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FIELD OF THE INVENTION [0001] The present invention relates to medical systems and methods and more particularly, to an electroencephalograph (“EEG”) based system for monitoring or automatic guidance of anesthesia, analgesia, and amnesia during surgical operations. BACKGROUND INFORMATION [0002] Anesthetic drugs which, when properly administered, induce loss of awareness, are often used for painful and serious medical procedures such as surgical operations. A general anesthetic, when properly administered, will cause a progressive depression of the central nervous system so that the patient loses consciousness. A local anesthetic, however, only affects sensation at the region to which it is applied. [0003] Generally, the patient, prior to a surgical operation, is anesthetized by a specialized medical practitioner (“anesthesiologist”) who may be a Board Certified physician, or a specially trained nurse anesthetist. One or more volatile inhalational liquids or gases may be administered (e.g., nitrous oxide, methoxy flurane, sevoflurane, isoflurane, desflurane, ethylene, cyclopropane, ether chloroform, halothane, etc.). Certain desirable anesthetic gases such as Ciboflorane® (Abbott Lab) may sometimes not be used because of their cost. Alternatively, nonvolatile drugs may be administered by injection or intravenous infusion (e.g., flumazenil, thiopentone, Retamine, remifentanyl, midazolam, pentothal, propofol, evipal procaine and etomidate® (Abbott)). The objectives of general anesthesia administered prior to a surgical operation, may include: a) blocking the patient's movements and relaxing the patient's muscles to prevent involuntary reflex muscle movements which may interfere with the operation; b) preventing the patient from being aware (i.e., loss of consciousness, or sedation) during the operation; c) preventing the patient feeling pain (i.e., loss of sensation, or analgesia) during the operation; and d) preventing the patient from remembering intra-operative events or discussions (i.e., amnesia). Furthermore, the anesthesia should not lower blood pressure to a dangerous extent (e.g., below 50 mm Hg for mean arterial pressure (MAP)). [0008] These objectives of general anesthesia may often be attained by separate administration of hypnotic or sedative, analgesic and amnesic agents, in accordance with the clinical judgment of the managing anesthesiologist evaluating the apparent state of the patient and a variety of vital signs. [0009] In order to monitor the “anesthetic depth” or “plane of anesthesia” of the patient, a skilled anesthesiologist looks at the vital signals of the patient (e.g., breathing, blood pressure, etc.) to determine if more, or less, anesthetic is required. Often he/she looks into the patient's eyes to determine the extent of the dilation of the pupils as an indication of the level (or depth) of the effect of the anesthesia. Complete reliance on the availability, skill and attention of the anesthesiologist presents problems in some situations. In addition, respiration may be artificially controlled (e.g., by a respirator) and/or medications may block or alter useful autonomic signs. In the absence of graded neurological reflexes, the depth of suppression of brain activity related to awareness often may not be accurately gauged. The mute, paralyzed patient cannot report the experience of pain. Furthermore, pain cannot be reliably inferred from vital signs since they may be blocked by the presence of medications. In some operations (e.g., heart surgery), the head is covered so that the patient's eyes cannot be viewed and pupillary dilation is not apparent. No reliable estimate may then be made of the possibility that the patient may be aware of environmental events, experience pain and/or be able to store and retrieve memories about unpleasant experiences. Furthermore, during prolonged operations (e.g., 10 to 15 hours or more), the attention of the anesthesia nurse or anesthesiologist may not be constant. [0010] Also, at times, an anesthesiologist may not be available (e.g., in emergency or battlefield situations). Similarly, in isolated geographic locations, it may be impractical to move a patient requiring an operation to a hospital where an anesthesiologist would be available. However, a physician or surgeon may be able to perform a required operation if there were some way to effectively and safely anesthetize the patient. [0011] U.S. Pat. No. 2,690,178 to Bickford purports to describe an automatic system for applying anesthetic to a patient while monitoring the patient's brain waves to monitor the effects of the anesthetic. Bickford used an integrated potential output of the cortex to judge the efficacy of the anesthetic. (See also, U.S. Pat. Nos. 4,280,494 and 4,533,346 to Cosgrove et al. entitled “System for Automatic Feedback-Controlled Administration of Drugs”). The EEG measure used is an “EEG power response” (i.e., a total power output of the brain). However, the use of the single measure of integrated cortex output as described in the Bickford and Cosgrove patents may not provide a reliable control signal for applying a general anesthetic. Different anesthetics have different impacts on power output and several may actually cause an increase in a power detected by a cortical EEG. Furthermore, in some instances, the nature of the power detected changes depending upon electrode position. In addition, not only do different anesthetics have different effects upon the EEG, but those effects may vary from patient to patient as a consequence of different pre-operative medications and/or different biochemical sensitivities. [0012] The following patents which describe methods and apparatus for monitoring and/or controlling the provision of anesthetic to patients are hereby expressly incorporated by reference: U.S. Pat. No, 6,315,736 to Tsutsumi et al.; U.S. Pat. No. 6,317,627 to Ennen et al; U.S. Pat. No, 6,016,444 to E. R. John; U.S. Pat. No. 5,699,808 to E. R. John; U.S. Pat. No. 5,775,330 to Kangas et al.; U.S. Pat. No. 4,557,270 to E. R. John; U.S. Pat. No. 5,010,891 to Chamoun; and U.S. Pat. No. 4,869,264 to Silberstein. SUMMARY OF THE INVENTION [0013] The present invention is directed to a method for monitoring anesthetization of a patient undergoing a medical procedure, comprising the steps of (a) removably connecting a set of at least two electroencephalograph (“EEG”) electrodes to the scalp of the patient, (b) administering sufficient anesthesia to the patient so that the patient attains a plane of anesthesia selected by an operator and (c) amplifying and digitizing brain waves of the patient after step (b) and before beginning the medical procedure to obtain a first set of digital data in combination with the steps of (d) amplifying and digitizing brain waves of the patient during the medical procedure to provide a second set of digital data, (e) analyzing the first and second sets of digital data in at least one of a time domain and a frequency domain; and (f) computing from the data analysis of step (e) separate trajectories for at least two different indices of an anesthetic state of the patient during the medical procedure, the indices being selected from a group including a Depth Index (DI), a Memory Index (MI) and a Pain Index (PI), wherein the DI corresponds to a depth of anesthesia of the patient, PI corresponds to a sensitivity of the patient to pain and MI corresponds to an ability of the patient to form and store memories. BRIEF DESCRIPTION OF DRAWINGS [0014] FIG. 1 is a block schematic drawing of an exemplary apparatus according to the present invention. DETAILED DESCRIPTION [0015] The present invention utilizes electrophysiological methods to provide automatic quantitative evaluation separately for a level of awareness (sedation), a sensitivity to pain and/or an ability to comprehend auditory speech and store memories of intraoperative or environmental events. This information may be provided as a monitor to aid an anesthesiologist in the management of an individual patient or may be used as an input to a servo system which automatically delivers anesthetic, analgesic and amnesic agents to optimize the state of a patient. [0016] In particular, before an operation, the anesthesiologist may attach a plurality of removable EEG electrodes to the scalp of the patient (preferably, two to eight electrodes and more preferably, five electrodes). If five active electrodes are used, they may, for example, be placed at F1, F2, F7 and F8 active positions as would be understood by those skilled in the art. Reference electrodes may then be placed, for example, at FPZ and CZ (vertex) and the cheekbone. In addition, an earpiece insert may be used to apply audio stimulus to the patient, and a finger cot electrode may be used to apply slight electrical shocks as somatosensory stimulus. The anesthesiologist may than administer a selected anesthetic to place the patient at a desired depth of anesthesia using his clinical judgment, based upon the patient's vital signs and clinical experience. At that time, measurements of the patient's EEG, AER (Auditory Evoked Response) and/or SER (Somatosensory Evoked Response) may be automatically made to provide an adequate self-norm (reference or base line). Measures of vital signs such as heart rate, stroke volume, blood pressure, respiration and temperature may also be obtained and monitored from the anesthesiology console. In addition, oxygen saturation may be measured, for example, using an NIR sensor such as “INVOS”® In Vitro Optical Spectroscopy) (Somanetics). A QEEG system, which monitors the electrophysiology of the patient, may then be able to detect changes in the clinical state of the patient (e.g., changes in the depth of anesthesia, sensitivity to pain, or probability of memory storage) before there are clinical or qualitative signs of change (e.g., movement, tachycardia, or increased blood pressure). During the operation, the QEEG system automatically and continually collects on-going EEG and also challenges the patient with regularly repeated periods of stimuli to provide evoked potentials, such as AER and SER. These data are subjected to automatic artifact removal and features selected from the self-norm are continuously analyzed and displayed as three trajectories. In one embodiment of the invention, deviations beyond confidence limits (i.e., a reference band) for any of the trajectories, may automatically control the application of the different agents to achieve or maintain the desired depth of anesthesia. Alternatively, this data may be displayed to the anesthesiologist who may then make judgments based on his experience, etc., as to what measures are required to optimize the anesthesia of the patient. [0017] In accordance with one embodiment of the present invention, a Guidance of Anesthesia, Analgesia and Amnesia System (“GAS”) includes an ERG system and automatic quantitative analysis of the EEG (“QEEG”) and sensory evoked responses. It serves as an intra-operative multimodal monitor to inform the anesthesiologist of the present state of anesthesia of the patient or, if desired, to automatically administer dosages of one or more agents during an operation to facilitate management of the patient. If an anesthesiologist or intensivist is not available, the system may permit a physician or paramedical personnel to manually or automatically maintain the desired level of anesthesia in a patient. [0018] In contrast to conventional systems, the GAS separately evaluates several dimensions of the state of the patient. In addition to serving as a monitor to aid optimal manual management of the patient, the present method and system enables an automatic control of multiple dimensions of anesthesia. Separate measures quantify indices for the depth of anesthesia (DI), sensitivity to pain (Pain Index or PI) and likelihood of storage of Memory Index (MI). [0019] The first dimensional measure, the Depth Index (DI), relates to a depth of anesthesia. If the patient has attained a satisfactory depth of anesthesia, consciousness has been lost and the patient's muscles are sufficiently relaxed so that involuntary muscle movements do not interfere with the operation. This is an over-all measurement of the depth of anesthesia. An example of an agent primarily directed to attain and maintain general anesthesia level (DI), is propofol (“Diprivan”® by Zeneca Phar). The measurement of the patient's immediate sensitivity to pain is called the “Pain Index” (PI) and an example of an agent primarily directed to controlling PI is remifentanyl (selective mu-opiod with a very short half-life). The measurement of the functional state of the patient's memory is called the “Memory Index” (MI). An example of an agent directed primarily to control MI is midazolam (Versed). [0020] General anesthetics produce a progressive depression of the central nervous system. Generally, they produce an irregular descending paralysis of the central nervous system and suppression of the sensory cortex. The paralysis successively affects the basal ganglia, the cerebellum and the spinal cord; without suppression of the medulla (respiratory and cardiac functions). The sensory input to the cortex is suppressed because the sensory pathway from the brain stem reticular formation and the thalamus is inhibited. The electrical activity of every local brain region as well as interactions among regions is auto-regulated by a complex neuroanatomical homeostatic system, producing an EEG power spectrum which is generally predictable in healthy persons of any age and independent of ethnic background, in the absence of perturbing illnesses or chemical substances. Serial measurements are extremely stable and reproducible within any individual. Anesthetic agents alter the relationships within the homeostatic system, producing certain changes in the power spectrum, which have been shown to be invariant with loss of consciousness caused by any agent but reversible with the return of consciousness. Anesthetics act upon pacemaker oscillator cells which normally regulate the stable spontaneous EEG rhythm, generating a power spectrum with a peak that is generally in the center of the Alpha band (8-12 Hz)) via the nucleus reticularis. This inhibits the thalamus via the neurotransmitter gamma-amino butyric acid and, in effect, closes the sensory gate to the cortex. The pacemaker cells are hyperpolarized by this inhibitory influence of n. reticularis, thereby slowing their oscillations to produce slower Alpha waves and enhancement of Theta waves. The slower Alpha waves and Theta waves, and other distinctive alterations of the patient's normal regional EEG power spectra, and electrophysiological signs of interactions between regions, may be detected by the QEEG analysis system of the present invention. Using pattern recognition algorithms, which may be discriminant functions, quantitative features are continuously extracted from ongoing EEG data and used to construct a scale for depth of anesthesia, the Depth Index (DI). This information may be presented to the anesthesiologist to serve as an adjunct to the manual management of the patient. Alternatively, servo systems may be used to administer appropriate agents automatically to control the DI. [0021] The present invention presents a relatively simple and yet effective and reliable system and method for the monitoring and/or control of the multiple dimensions of anesthesia. The method is based upon computation of the covariance matrix of spectral quantitative EEG (QEEG) features within each electrode and among a set of electrode positions. In its simplest form, it uses a set of anterior (frontal) EEG electrodes on the forehead. When the patient attains the surgical plane of anesthesia, the power in each band will change within each electrode and the cross-spectral matrix will change. One way to display this data may be as a scrolling waterfall of the power spectra from each lead, updated at periodic intervals (e.g., Compressed Spectral Array or “CSA”). The means and standard deviations of baseline samples of the covariance matrices and the measures may be used to define a self-norm. As updated samples of EEG are analyzed, a comparison relative to population or self-normative data is made of the absolute and relative EEG power within each of the electrodes continuously or within selected frequency bands, and the symmetry and coherence relationships among these spectral measurements within and between the set of electrodes. This comparison preferably entails transformation of every measure for Gaussianity and rescaling the measure to the common metric of probability by computing the standard or Z score for each variable. A second way to display this data may be as a scrolling waterfall of the Z-transformed spectra or ZSA. A third way to display this QEEG data may be to extract selected, differentially sensitive variables from the EEG and compute separate composites such as Mahalanobis distances or discriminant scores to provide scales which accurately assess DI, PI and MI. [0022] These scores may be displayed as separate, updated numerical values or as separate updated trajectories of the values versus elapsed intra-operative or monitoring time. If the patient begins regaining consciousness, sensitivity to pain or the ability to comprehend speech and store memories, as shown by the trajectory for the corresponding dimension, the confidence level (mean+2 standard deviations) around the self-norm (baseline) for that dimension will be exceeded. An alarm may be sounded or a vibratory signal transmitted. If that occurs, more agent, directed toward the specific dimension displaying change of state, may then be delivered (titrated) to the patient manually by the attending medical personnel or, alternatively, the corresponding agent may be automatically delivered via a self-adaptive servo algorithm. Conversely, if these changes are excessive, less agent will be indicated relative to the self-norm, and the attending personnel or the servo system may reliably intervene to control the administration of each of the agents in a manner optimized for the individual patient. [0023] The QEEG variables may be augmented by sensory evoked potentials (“EPs”) and autonomic data to obtain measurements for quantifying the pain (PI) and memory (MI) indices. To obtain the sensory EPs, the system presents to the patient a programmed sequence of concurrent or sequential stimulations in one or multiple sensory modalities. Preferably, two modes are used: (1) auditory stimulation (e.g., auditory clicks or rectangular tone pips at about 65 dB, modulated at a frequency selected to maximize EP amplitude, such as, approximately 1500 Hz), delivered to the ears via air tubes from an audio source at an ‘auditory tracer’ repetition rate F1; and (2) somatosensory stimulation consisting of electrical shocks (e.g., 0.2 msec pulses of constant current at about 12 mA delivered to a peripheral nerve, preferably via a finger cot, at a second ‘somatosensory tracer’ rate (F2). The tracer rates F1 and F2, although concurrent, may preferably be selected at different prime number frequencies to permit separation of the different EP's and avoid interference. Concurrent stimulations permit a more rapid, examination and provide the patient's responses more quickly. However, intermittent sequential stimulation may be more effective as habituation may readily be avoided by randomizing sequences or other maneuvers to maximize EP amplitudes. Based an the responses to the auditory stimuli, the system tests the functional state of the lateral lemniscal auditory pathway in the brain stem (Brain Stem Auditory Evoked Response or BAER), the thalamus (Mid-Latency Auditory Evoked Response or MLAER) and the auditory cortex (“AER”). Based on the responses to electrical stimuli, the system tests the functional state of the spinal cord, medial lemniscal pathways in the brain stem and the somatosensory cortex (Somatosensory Evoked Response, or SER). [0024] One way to quantify the EPs is to utilize separate tracer frequencies, F1 and F2, in order detect the different times of presentation of the stimuli in the two different modalities to provide ‘trigger pulses’ needed to compute the wave shape of each of the average evoked responses in the time domain, using the conventional evoked response averaging techniques. This selective averaging may be performed whether the stimuli are presented simultaneously or sequentially. The raw wave shapes may be optionally displayed as a scrolling waterfall, or Compressed Evoked Potential Array (CEPA). The system may extract from each such wave shape a numerical feature of merit or a metric (e.g., such as the length of the curvilinear outline or the area under the EP wave shape). From a baseline sample for both the AEPs and SEPs, the mean and standard deviation of the distribution of such EP measures may be specified. Subsequent samples may be Z-transformed to provide a common metric of probability. These Z-scores may be displayed as periodically updating numerical values or as continuously updating trajectories. They may also be combined with the Z-scores of the separate QEEG measures found to be sensitive to pain or memory storage into a ‘State Vector’ in order to provide a multi-modal and more sensitive and specific assessment. Such multivariate vectors may be computed as the square root of the sum of the squared separate Z-scores. Such vectors may combine QEEG and SEP Z-scores to yield a Pain State Vector, QEEG and AEP Z-scores to yield a Memory State Vector, or QEEG, SEP and AEP Z-scores to yield a Brain State Vector. [0025] Another way to quantify the EPs is to perform very narrow band (e.g., using 0.5 Hz frequency bins) FFTs on the EEG recorded in the absence of the tracer stimuli and during intermittent or constant periods of stimulation. Using the very narrow band power computed over a sliding window of appropriate length (e.g., 20 to 60 seconds), the power in the bin corresponding to F1 or F2 is divided by the mean power of the two adjacent bins of lower frequencies and the two adjacent bins of higher frequencies. The power of the EEG is equal to its variance because the variance of a set of samples of a variable equals the mean squared value minus the square of the mean value across the set and the mean value of the EEG is zero. Thus, this quotient of powers is equivalent to an F-ratio. In this way, without actually computing an average response wave shape, a statistically interpretable FIGURE of merit can be readily provided for the responsiveness of the patient to somatosensory or auditory stimulation. By constructing a database of such F values in a baseline sample, the updating F ratio's can be Z-transformed to probability and processed for display on a monitor or inputs to a servo controller just as the features extracted from the EP wave shapes. [0026] Measures of vital signs (e.g., heart rate, stroke volume, blood pressure, respiration and temperature) may also be obtained and monitored from the anesthesiology console. In addition, oxygen saturation may be measured (e.g., using an NIR sensor such as “INVOS”® (In Vitro Optical Spectroscopy). A preferred comprehensive system monitors the electrophysiology of the patient, detecting changes in available measurements of such vital signs. Any such data which becomes available may be treated the same way in principal (i.e., a baseline sample may be collected to serve as the reference state). The quantified feature(s) may then be assembled into a baseline distribution sample. After transforms for Gaussianity, if necessary, the mean and standard deviation of each measure are calculated. Z-transformation of the raw measure values now rescales them all in the common metric of probability. These may now be presented on the screen as numerical values or displayed as continuous updating trajectories as univariates or as multivariate “vital sign vectors” combined by computing the square root of the sum of the squared Z-scores. While a mathematically more correct multivariate may require correction for intercorrelations using the covariance among the set of measures, the simple square root of the sum of squares errs in the direction of possible over-estimation of the vector length, which acts as a ‘fail-safe’ early warning signal. In particular, the normalized variability in heart rate (HRV) has been reported to be a sensitive autonomic indicator of pain, Z (HRV) might contribute enhanced sensitivity if incorporated into the “pain vector” together with the selected pain-sensitive QEEG variables and selected SEP features. [0027] As shown in FIG. 1 , prior to a surgical operation, a plurality of EEG electrodes (e.g., EEG electrodes 2 a - 2 e ) are removably secured to the scalp 1 of the patient. Preferably, the EEG electrodes will include the following forehead locations: F1, F2, F7, F8 (all 4 active) and FPZ (reference). The capital letters refer to position location names in the International 10/20 Electrode Placement System as would be understood by those of skill in the art. Additional removable electrodes may be utilized as desired while additional reference electrodes (unilateral or linked) may be removably positioned on the patient's mastoids or earlobes (A1, A2). An electrode may be placed on the shoulder over Erb's Point to serve as confirmation that SEP are being conducted through the spinal cord. EOG electrodes may optionally be placed at the outer canthus of the eye to facilitate artifact rejection. As would further be understood by those of skill in the art, electrodes may also be placed on the central vertex (Cz) to record brainstem potentials, on the chest for EKG recording and on the cheekbone to serve as the ground. [0028] The electrodes 2 a - 2 e preferably use a standard electrolyte gel, or other application method, for contact so that the impedances of each electrode-skin contact are below 5000 ohms. Alternatively, for some applications, needle electrodes, a pre-gelled electrode appliance with adhesive or other means of fixation, or an electrode cap or net with previously located electrode positions may be used. The EEG system, described below, automatically checks the electrode-skin impedance at each electrode at frequent intervals, (e.g., every minute), and displays a warning (e.g., a red LED light) if any such impedance falls below 5000 ohms. [0029] As shown in FIG. 1 , the patient's head 1 is connected to the patient module which includes a desired number of electrodes 2 a - 2 e. FIG. 1 shows four active electrodes. [0030] Each of the electrodes 2 a - 2 e is connected to a respective one of the EEG/EP amplifiers 3 a - 3 e, with each electrode lead being connected to its respective amplifier. Each amplifier 3 a - 3 e has an input isolation switch, (e.g., a photo-diode and LED coupler), to prevent current leakage to the patient. The EEG amplifiers 3 a - 3 e are high-gain low-noise amplifiers, preferably having, for example, peak-to-peak noise of 1 microvolt or less, a frequency range of 0.5 to 200 Hz, fixed gain of 10,000, common mode rejection of 100 db or more (4 amplifiers). Two auditory or somatosensory brainstem EP amplifiers may have, for example, a peak to peak noise of less than 1 microvolt, a frequency range from 30 to 5000 Hz, gain of 100,000 (2 amplifiers) and a common mode rejection of at least 100 dB. Alternatively, high-gain amplifiers may be used with fixed gain of, for example, 10,000 of which 2 may be remotely switched to a fixed gain of, for example, 100,000. Amplifier parameters may be switched for separate data collection of EEG and EP, separate amplifiers may be connected to the same electrode input, or a programmable A/D multiplexer converter may be used to output the separated data. [0031] The amplifiers 3 a - 3 e are connected to a four channel analog-to-digital multiplexer 4 (A/D multiplexer). The multiplexer 4 samples the amplified analog brain waves at a rate of, for example, 5 KHz for each channel. The multiplexer 4 is connected to “buffer signal” 5 which stores the signal, and “buffer noise” 6 which stores samples of the “noise”, that is, amplifier output of EEG when no stimuli are delivered to elicit EPS. The buffers 5 , 6 and A/D multiplexer 4 are connected to a dedicated digital signal processor (DSP) 7 , such as, for example, model TMS320C44® (Texas Instruments). Alternatively, the DSP 7 may be a Pentium 4 Processor® (Intel) or a digital signal processor such as the TMS320C44® (Texas Instruments) along with a microprocessor. The DSP may be controlled by, for example, a software program 8 and connected, through a dedicated 512-point FFT 9 (Fast Fourier Transform) to a digital comb filter 10 . [0032] The comb filter 10 is connected to, and controls, the IFFT 11 (Inverse Fast Fourier Transform). The output of IFFT 11 is connected to the system microprocessor 12 . The microprocessor 12 is also connected to, and controls, the stimulus generator 13 (e.g., lights, loudspeaker, shock, device, etc.), the mass storage 14 (e.g., a hard disk), the display 15 (e.g., a CRT), a printer 16 and a keyboard operator control panel 17 . The microprocessor 12 operates under control of a software program 18 . Preferably, as shown, the stimulus generator 13 is connected to “auditory” 20 , which generates clicks at, for example, 100 dB and at an “auditory tracer” frequency “F1”. The clicks may then be transmitted to the patient via, for example, earphones or air tubes. The stimulus generator 13 is also connected to “somatosensory” 21 which delivers electrical stimulation (e.g., constant current electrical shock pulses), for example, of 200 microseconds duration and 12 milliamps current. The electrical stimulation may be transmitted to the patient via, for example, a fingertip cot at a second, and different, “somatosensory tracer” frequency “F2.” [0033] The digital comb filter 10 may be as described in U.S. Pat. No. 4,705,049, incorporated by reference herein. The comb filter may considered a series of band pass and band stop filters which are responsive over a selected range. The selected range may for example be is 0-3000 Hz and may, preferably be 0-1400 Hz. Preferably, band pass filters may operate at 10-580 Hz, 600-640 Hz, 720-800 Hz and 900-1400 Hz with band-stop filters at 0-10 Hz, 580-600, 640-720 Hz, 800-900 Hz and above 1400 Hz. Thus the band pass filters form the “teeth” of a comb and are selected to accord with frequencies in which a signal/noise ratio is acceptable. The band-stop filters are selected to remove frequencies in which the noise is excessive. [0034] The multiplexer 4 may be programmed to obtain samples of the signal and of the noise. The “noise” is preferably obtained when there is an absence of evoked potential stimuli and the “signal” is obtained during stimulation, beginning with presentation of the stimuli or after a pre-selected delay. The program 8 with its controlled DSP 7 conditions the input signals and insures that they are valid biological signals. Such validation checks on the input signals include periodic calibration measurements and impedance measurements and continuous automatic artifact rejection algorithms. The microprocessor 12 automatically provides a timed set of two kinds of stimuli for simulator 13 : An audio sound from a speaker or earphones and a tactile signal from the electric shock of about 0.2 msec duration and about 12 mA of intensity delivered to electrodes via the fingertip cot. Auditory clicks (e.g., about 100 db SPL) may be delivered through a stethoscope earpiece by air conduction tubes from a magnetic speaker or other arrangement as would be understood by those skilled in the art. Ideally, these clicks may be rectangular pulses of 1500 Hz tones at a repetition rate of about 40/sec. The rate of stimulus may range between 7-50/second and may more preferably range between 35-45/second (i.e., eliciting a 40 Hz auditory steady-state evoked response (40 Hz) at an auditory tracer frequency 1 (F1)). [0035] The patient's brain responds to these stimuli, providing “Evoked Potentials” (EP which are averaged to reduce noise. Sample size varies with stimulus modality, ranging from 100 (VEP) to 512-2048 (BAER/BSER). The average EP is the sum of samples time-locked to the onset of the stimuli divided by the number of samples, to provide an updated average. [0036] The software program provides patient information. Typically, the patient header gives the patient's IDS number, age and the date of the operation. In addition, it may contain the name of the physician, anesthetist or other operator and the nature of the procedure. The time is provided by a time code generator, which records both local time and elapsed time directly on the EEG tracings, so that events may be retrieved from any acquisition session given input to the database of the date. Retrieved data should include all clinical protocols and physiological documentation, including the trajectories of the indices. The software program provides the data analysis module, described in detail elsewhere in this application. [0037] After analysis of the data, the microprocessor 12 provides information to the display 15 which info ns the anesthesiologist or medical personnel of the state of the patient with respect to the 3 dimensions being monitored. This data can then be used to guide manual administration of agents in accordance with the clinical judgment of the physician. Alternatively, this information may be provided as control signals to a delivery control 19 , which, automatically controls three agent infusion pumps 22 a - 22 c (e.g., Pumps A, B and C) to achieve a desired balance of the three agents. If the anesthetic is gaseous, the anesthesia control 19 may control valves of gas cylinders (not shown) as would be understood by those of skill in the art. [0038] Each of the three state indices (i.e., the DI, the MI and the PI) are separately analyzed by the computer software of the present invention, in the frequency domain and also in the time domain. [0039] The following is a preferred exemplary method for frequency domain analysis of the depth of anesthesia to obtain the DI. The frequency domain, from 0-200 Hz, is divided into narrow bins (e.g., for 0.50 Hz bins, 400 bins are set), QEEG variables are extracted from 0.05-1.5 Hz (low delta) to gamma 2 (35-50 Hz). Based upon experience (e.g., based on data from sets of prior patients), features are selected from the data from univariate (i.e., single electrode) and multi-variate (i.e., composite sets of electrodes) measures. [0040] The data, in the frequency domain, is preferably converted by a Fast Fourier Transform (FFT) and then may be converted again by an Inverse Fast Fourier Transform (IFFT). The FFT is the preferred method for calculating a power spectrum of the patients' brain waves. Using the Fourier transformation, the complex wave diagram of the EEG is divided into underlying oscillation components, followed by a translation from the time domain into the frequency domain. The squared amplitudes of these oscillation components form the “power spectrum.” Further processing of the results of the Fourier analysis may include the extraction of spectrum parameters as well as continued statistical calculations. IFFT may be performed after analysis of the relative phase variances at each frequency, of segments containing EP signals and segments containing only noise samples, removing noise by setting appropriate coefficients to zero and reconstructing EPs with the noise digitally removed. Parameters which may be derived from the spectrum, include, for example, the total power and absolute and relative power in different frequency bands. The median, the spectral edge frequency, and the dominant frequency may also be used as parameters. The median frequency is most often defined as the 95% quantile (i.e., 95% of the total power of the spectrum is below this frequency). The dominant frequency is the frequency with the highest power. Mean powers within selected band intervals are calculated, transformed to achieve a normal or Gaussian distribution. Mean values and standard deviations of a baseline set of samples of each QEEG or EP variable are obtained during an adequate and appropriate reference period to define the patients “self-norm.” The relevant population norm is obtained (i.e., from a look-up normative table). Z-scores are calculated for each univariate or multi-variate QEEG or EP measure, relative to both the self- and population-norms. For each variable, a sliding window, for example, 20 seconds of data which is continuously updated, is formed which integrates sequential segments (i.e., 2.5 second artifact-free EEG samples). From the updated mean value of the sliding window, the trajectory of each variable and the DI, PI and MI are calculated. The trajectory of each index is presented to the physician as a quantitative monitor of each dimension of patient state to provide guidance for the optimal management of the patient or optionally may be used to automatically control the delivery of various agents to the patient, preceded or accompanied by display of the intended maneuver to the operator. [0041] The EP wave shapes are stored. The peaks of the EPs are detected and an EP Index (“EPI”) is computed. The EPI reflects the area under the EP curve, the length of the contour of the EP wave shape (“string length”), its peak amplitudes and its latencies. An updating EP waterfall type display may be computed (Compressed EP Array, or CEPA), that scrolls (with time) with the EP peaks marked, for example, as brightened points or by arrows or stars. The automatic comb filter, mentioned above, may be used to define an optimum digital filter for computation of any EPs . As in the case of the BAER/AER, for all EPs, the data is stored, the peaks are detected, and an EP Index (“EPI”) is computed. The EPI reflects the area under the EP, and its string length, peak amplitudes and latencies. An updating scrolling waterfall display may be computed and displayed (on the monitor) with the EP peaks marked. In addition, separate updated sliding windows of data may be computed and displayed (on the monitor) for the patient's vital signs. Preferably, these vital signs include heart functions, as detected by QRS peaks, heart rate variability, respiratory cycle, BP (Blood Pressure), oxygen saturation, and temperature. These vital signs windows are computed using the means value and standard deviation for each of the vital signs. [0042] The data collected and analyzed in the time domain and frequency domain are used to form the patient's multiple indices. These are, preferably, the Depth Index (PSI) (assesses anesthesia level), the Memory Index (MI) and the Pain Index (PI). A preferred method of computing these indices may be to use discriminant analysis as described in U.S. Pat. No. 5,083,571 relating to psychiatric classification of a patient with respect to a class or specific disorder and the inventor's prior U.S. Pat. No. 6,016,444. In general, discriminant analysis uses “discriminant functions”, U.S. Pat. Nos. 5,083,571 and 6,016,444 are hereby expressly incorporated by reference in their entireties. [0043] A discriminant function is composed of weighted combinations of subsets of variables. In the case where patients' norms are used, the subsets are Z scores. Each of the subsets (each Z score) is selected, on the basis of experience and experimentation, because it significantly contributes to the discrimination (e.g., discrimination between anesthetized and yet feeling pain and anesthetized and not feeling pain). The weighting of the subsets, the contribution of each Z score toward the discrimination, is also based on experience and experimentation. [0044] The distributions of features of two groups of subjects, where the groups belong to different diagnostic categories, may be thought of as two clouds of points in a multidimensional space in which each dimension corresponds to a feature. For example, each feature is a Z score and the diagnostic categories, for example, are the degrees of anesthetization to prevent pain. There may be no significant differences between two groups (i.e., significant differences in other dimensions). A problem arises when these clouds of points overlap, i.e., when there is no apparent significant difference between two groups with respect to some features. A solution is to attempt to define a boundary, through the clouds of points, to create a first zone which includes as much as practicable of the first group, and as little as possible of the second group, and a second zone which includes as much as practicable of the second group and as little as practicable of the first group. [0045] The third zone is defined as an overlap region where no reliable classification can be made. In principle, a discriminant function weights the values of selected features for a new patient and adds these weighted values to specify a single point in the relevant multidimensional space. This single point then would be in one of the three zones, and the individual's category (in each of the DI, MI and PI) would be classified accordingly. The discriminant analysis is performed during the operation using Z scores based on self-norms (i.e., comparison with the same patient pre-operation) and population norms (i.e., patients of the same age and condition during similar operations using the same anesthetic). After the DI, MI and PI are computed, these computations may be used to automatically administer the various anesthetics to the patient. In addition, these indices are displayed to the operator on, e.g., a monitor. They may also be recorded and printed out for analysis after the operation. The DI gives an assessment in QEEG, the depth of anesthesia, the Memory Index (MI) is obtained, in QEEG, by combining the F (AER) value with selected AER features (i.e., assessment of reception). This should give an indication of the patients' ability to comprehend speech, i.e., the conversation of the doctors and nurses during the operation. The Pain Index (PI) is derived from the F (SER) values and selected SER features. In addition, non-QEEG autonomic measures, which are responsive to pain, may be used and computed into the PSI, PI and MI. [0046] In order for the tendencies of the DI, MI and PI to control and/or monitor the quantities of the various anesthetics, each of which is primarily directed to one of those indices, it is necessary to measure the effects of those anesthetics on the individual patients. Population norms are based on gender, age, surgical procedure and specific anesthetics. However, individuals, due to their metabolisms and other factors, may react differently from the average patient of such population norms. [0047] The preferred method of determining the correct anesthesia dosage for each patient is to test the patient using the 2 or 3 different anesthetic agents which will be used for the operation. This QEEG method may analyze the particular patient's brain wave reaction to each anesthetic agents, one at a time, and derive a “transfer function” for each patient, reflecting that patient's biochemical reactions to each anesthetic agent. For example, one patient may require an injection of 5 milliliters of an anesthetic agent to prevent a feeling of pain, as shown by his PI, while another patient may require twice that dosage to obtain the same effect. The transfer function is preferably updated at regular intervals (i.e., for example every 20 minutes) during the operation, as it may change if the operation lasts longer than 15-20 minutes. [0048] A preferred method for calculating each of transfer function may include perturbation analysis. After the patient has been anesthetized to the desired plane of anesthesia, and his QEEG self-norm (reference set -point) has been obtained, the system halts delivery of the first anesthetic, for example, the anesthesia remifentanyl primarily directed to control pain (PI) or may diminish the delivered amount by some fraction, for example, 50 percent. The patient then starts, in a gradual way, to show a change in the relevant index, e.g., DI, MI or PI. At a selected distance from a set point, preferably about 2.5 Standard Deviations (S.D.), (i.e., probability P<0.01), the application of the particular anesthetic agent is resumed. The system, in this method determines the number of anesthetic units withheld from the patient to cause the change in the relevant index. For example, it may require withholding 3 units for a particular patient to be roused to 2.5 S.D. from the set-point of the PI. The amount of anesthetic agent withheld, called the “test correction amount,” is an approximation of the amount of anesthetic agent required to restore that particular patient to the selected index when he has deviated from his set point by 2.5 S.D. A selected fraction of that amount is then administered, as a first approximation, to see whether this restores the patient to the set point. The amount required to restore the patient to the set points is defined as the “correction amount” and is retained in system memory and is administered to the patient whenever the patient has deviated from his set-point by 2.5 S.D. or more. [0049] Adequate determination of the transfer function may require positive, as well as negative perturbations. Preferably, periodic evaluation is shown by a significant change in each index (DI, MI and PI) caused by a small increment in the amount of anesthetic agent delivery, for example 10%. [0050] As shown in FIG. 1 , the anesthesia control 19 , under management of the microprocessor 12 , controls the administration of the different anesthetic agents. In this example, the anesthetic agents are injections and they are administered intravenously by infusion pumps A-C ( 22 a - 22 c ). For example, pump A ( 22 a ) may inject propofol (to control DI), while pump B ( 22 b ) injects midzolam (to control MI) and pump C ( 22 c ) injects remifentanyl (to control PI). Alternatively, as would be understood by those of skill in the art, any or all of the various anesthetic agents may be gases which are administered through controlled inhalation by the patient. [0051] For each index (DI, MI and PI), one infusion pump 22 a - 22 c is used to administer or withhold the anesthetic agent primarily directed toward controlling that index. For example, the DI is continually computed and compared to the desired value or desired range of values. The pump (i.e., pump A ( 22 a )) is energized (or not energized) to inject (or withhold) the corresponding anesthetic agent (e.g., propofol primarily to control the PSI). Similarly, the MI and PT are continually computed and a corresponding one of the pumps 22 (i.e., pump B ( 22 b ) or pump C ( 22 c ), respectively) is controlled to inject, or withhold, the anesthetic agent primarily directed to that index. [0052] As would be understood by those of skill in the art, the system of FIG. 1 may be implemented incorporating a dedicated freestanding computer, such as a PC, a laptop or other handheld device. Alternatively, the computer and monitor portions (as distinct from the pumps) may be implemented as part of a multi-modal monitor, which may also include sensors and displays of the patient's vital signs (i.e., blood pressure, respiration, O2 saturation, temperature and pulse (heart rate)). In any event, preferably, the display 15 is a monitor having a color screen to display graphics and alphanumerics. The operator control 17 may preferably include a standard ASCI key board which may be used to enter the patient header (e.g., name, age, gender, hospital number, date, medical procedure etc.) and comments (which may use function keys). Preferably, the display shows the results of the QEEG analysis continually during the operation. These displays may preferably include: a) The trajectories of each of the indices (DI, MI and PI) separately either on the same screen or in sequence; b) The set points and the selected ranges (permitted deviations) for each index; c) The current numerical value for each index; d) A waterfall type display or/and actual (raw data) brain waves showing, for each data channel, the FFT, AER and SER; e) Coded symbols and/or alarms for events which should be brought to the attention of the operator, such as epileptic spikes, epileptic seizures, burst suppression and abrupt changes in those vital signs (e.g., BP, respiration, pulse (heart rate), O2 saturation and temperature); and f) Wave shapes stored in an Epileptic form event file (epileptic spikes and seizures) calculated and displayed as well as their number and the their times of occurrences. [0059] Other embodiments of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a method for placement of certain medical devices. In particular, it pertains to the placement of electrodes in the field biopotential or electrophysiological monitoring. More particularly, it provides a new method for marking the skin of a subject where medical electrodes are to be placed including the placement of an electrode harness containing these electrodes. 2. Technical Background Electrodes are used in the medical field for monitoring biopotential of different subjects including patients. Groups of two or more electrodes are commonly used in order to allow for a variety of types of analysis. Such types of analysis include ECG (or EKG), EEG, EMG, and other such biopotential measurements using standard sensors such as electrodes. Many standard EKG measurements such as the commonly performed “stress test” require up to 12 separate electrodes to be placed on the skin of the subject in precise correlation to the patient's anatomical features. For many biopotential measurements, specific anatomical placement of electrodes is required for accurate measurements. In some instances, misplacement of electrodes by as much as a half an inch could lead to faulty measurements and misdiagnosis. Such accurate placement has in the past, and continues to require a highly trained medical specialist such as a doctor or nurse. Availability of one of the aforementioned medical specialists is generally not an issue in an inpatient setting. However, increasing use of “at home” or ambulatory monitoring presents the problem of placing the patient in a monitoring setting where no healthcare professional is available to properly place electrodes. Generally, an at home monitoring setup is conducted at the hospital where electrodes and accompanying wires or harness are accurately placed on the patient by a healthcare professional. The patient is instructed to wear the electrodes and harness 24 hours a day for in some cases a number of days without removal to ensure that the proper placement of the electrodes is maintained. The patient is also instructed not to bathe during this time period. Periodically, the patient may return for placement of new electrodes. There is currently a need in the healthcare field for a way to enable ambulatory monitoring of patients that allows for patients or their untrained healthcare providers to properly place monitoring electrodes. There are many factors contributing to this need for ambulatory monitoring. The greatest factor is the high cost of healthcare and especially inpatient care. Hospital stays routinely cost a thousand dollars a day, with intensive care unit (ICU) and cardiac care unit stays greatly elevating this cost. Many healthcare providers and insurance companies consider it a waste of valuable resources and scarce hospital beds to keep an otherwise stable patient in a hospital when their only requirement is medial monitoring. In the past, the problem with ambulatory monitoring has been its decreased accuracy due to patient compliance with monitoring procedures. Monitored patients routinely violate their doctor's orders by removing their electrodes because they are uncomfortable for mobile activities and do not allow the patient to bathe. Once removed, these electrodes are extremely difficult, if not impossible, for the patient or an untrained healthcare provider to correctly place the electrodes back on. Consequently, the monitoring suffers and the doctor cannot obtain an accurate diagnosis of the patient's medical condition. Therefore, there is a need for a method that allows for accurate placement of medical electrodes and associated harness in an ambulatory setting by a home caregiver or even the patient himself. It is an object of the present invention to provide a method of marking a subject's skin with a permanent or semi-permanent marking, which allows for any person, untrained in the medical arts, to properly place medical electrodes onto a patient to allow for precise biopotential monitoring. This method yields many advantages to both the patient and the doctor. Hospital stays are reduced leading to lower healthcare costs. Patient quality of life is increased because there are fewer trips to and stays at the hospital and because the patient can properly replace detached electrodes after bathing or other mobile activities. More accurate monitoring is achieved through allowing the patient to remove the monitor for short periods and permitting them to replace it properly. This allows for longer-term monitoring and increases the overall accuracy of monitoring. SUMMARY OF THE INVENTION The present invention relates to a method for placement of certain medical devices, and in particular, to the placement of electrodes in the biopotential monitoring field. More particularly, it provides a new method for marking the skin of a subject where medical electrodes are to be placed including the placement of an electrode harness containing these electrodes. There are numerous embodiments of the present invention, which are envisioned with a few of those listed below. The method for accurate placement of electrodes of the present invention provides a quick, efficient method of electrode placement and replacement. This method further allows homecare providers or even the patient to accurately place and replace electrodes for home health care or outpatient monitoring. In one embodiment, the present invention includes a method of facilitating placement of electrodes comprising locating an area of a subject's outer layer of skin on which to place an electrode used for biopotential monitoring; applying ink to under the subject's outer layer of skin in the form of a tattoo; and applying the electrode to the subject's outer layer of skin in reference to the tattoo. In another embodiment, the present invention includes a method for marking the skin of a subject in order to facilitate placement of EKG [dk1] electrodes comprising locating an area on a subject's outer layer of skin on which to place an EKG electrode; marking under or over the subject's outer layer of skin using a device to create a permanent or semi-permanent mark; and applying an EKG electrode on the subject's outer layer of skin in reference to the mark. In still another embodiment, the present invention includes a method applying an electrode array to a subject comprising the steps of locating an area on a subject's outer layer of skin on which to place an electrode array comprising at least two electrodes; marking under or over the subject's outer layer of skin using a device to create a permanent or semi-permanent mark to be referenced; and applying an electrode array comprising at least one reference mark to be aligned with the permanent or semi-permanent mark under or over the subject's outer layer of skin. Additional features and advantages of the invention will be set forth in the detailed description which follows, and in part will be readily apparent to those skilled in the art from that description or recognized by practicing the invention as described herein, including the detailed description which follows, the claims, as well as the appended drawings. It is to be understood that both the foregoing general description and the following detailed description are merely exemplary of the invention, and are intended to provide an overview or framework for understanding the nature and character of the invention as it is claimed. The accompanying drawings are included to provide a further understanding of the invention, and are incorporated in and constitute a part of this specification. The drawings illustrate various embodiments of the invention, and together with the description serve to explain the principles and operation of the invention. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 . is a schematic diagram showing one embodiment of the step of marking a subject under the method of the present invention. FIG. 2 . is a schematic diagram showing an electrode array with reference marks for alignment on the subject shown in FIG. 1 . FIG. 3 . is a schematic diagram showing the electrode array in FIG. 2 aligned to the markings on the subject shown in FIG. 1 . DESCRIPTION OF THE PREFERRED EMBODIMENT The present invention relates to a method for placement of certain medical devices, and in particular, to the placement of electrodes in the field biopotential monitoring. More particularly, it provides a new method for marking the skin of a subject where medical electrodes are to be placed including the placement of an electrode harness containing these electrodes. These medical devices include but are not limited to ECG, EEG, EMG, electrodes and the like. The method of the present invention comprises a number of steps and the various embodiments encompass variations of those steps. In the present invention, preferably some person locates an area on a subject on which to place an electrode, multiple electrodes, an electrode array or some combination thereof. The subject to be monitored can be any animal but preferably is a human. Generally, the area is determined by means known to those skilled in the art. Some factors affecting location selection include the end-use application or testing method which will preferably determine not only the intended anatomical location where the electrodes will be placed, but also the number and placement on the body of the subject. For example, cardiac electrophysiology protocols (ECGs) may simply require two electrodes for a low-resolution projection of cardiac electrical activity on the body surface. On the other hand, high-resolution studies may make use of more than 224 electrodes simultaneously. Each electrode placement configuration will have optimal anatomical location on the surface of the body for the most accurate readings, and the interelectrode distance will vary according to the number of electrodes used. There are a number of different types of electrodes available today. The major types of existing electrodes include the wet surface electrodes, dry surface electrodes, invasive electrodes, and the like. The wet surface electrodes are the most commonly used electrodes today. These electrodes require a wet electrolyte gel or conductive hydrogel solution to enhance signal performance. The most commonly materials used for these electrodes include solid silver, gold, sintered silver and silver chloride, carbon, and sponge saturated with conductive gel or also called pre-gelled electrodes. The dry electrodes on the other hand do not make use of conductive gel and include non-polarizable dry electrodes (e.g. NASICON-type ceramic); active dry electrodes with built-in amplifiers, capacitively coupled electrodes coated with dielectric substances, micropenetrators or spiked based dry electrodes, etc. The invasive electrodes include the needle type electrodes designed to fully penetrate the skin of the subject to form a direct interface with bodily fluids. Preferably the wet surface electrodes and the dry surface electrodes are used in the method of the present invention. Electrode arrays are flexible and conformable substrates which allow many individual electrodes to be placed together as a single assembly, while conforming to the shape of the anatomical geometry under the electrodes (e.g. chest, scalp, back, legs, etc). Electrode arrays are convenient devices that allow fast and accurate placement of multiple electrodes for multi-array recordings. Electrode arrays may contain built-on or preassembled electrodes, or appropriate connections for the attachment of electrodes. In addition, the electrode arrays may contain built-on circuitry and connection pads that independently connect the electrodes to a single and non-intrusive cable that connects to the signal receiver equipment. A reference point system may be included on the arrays to facilitate the identification of the appropriate anatomical regions to enhance the accurate placement of all electrodes. Overall the electrode arrays provide the opportunity for enhanced patient comfort and may reduce the risk of cross contamination as a result of minimizing or eliminating the potential for the overlapping of two or more electrodes and/or for signal interference as a result of two or more wires contacting each other. In addition it facilitates patient mobility and ambulation by minimizing or eliminating the number of cables required for connecting all electrodes to monitoring equipment. The electrodes and/or electrode arrays used in the present invention preferably also have distinct reference points, areas or locations that are used in the placement, respectively of the electrodes and/or arrays based on markings placed on and/or anatomical features of the subject. These reference points, areas or locations could include various markings on either the electrode or electrode array, voids or cutouts, and the like. One embodiment would be to line up these reference points, areas or locations on the electrode and/or electrode array with the marking(s) and/or anatomical features on the subject. Another step used in various embodiments of the present invention includes applying a marking under or over the subject's outer layer of skin. This marking can be any marking to those skilled in the art. The marking can include but is not limited to a tattoo both permanent and henna tattoos/semi-permanent tattoos (including but not limited to various types of tattoo inks), other types of permanent and semi-permanent inks, small marks with adhesive backing that can be placed on the subject's skin, small objects placed below the skin, a burn or branding, and the like. Preferably, the marking is either small or can be removed so when the subject is finished with the monitoring program there is little or no visibility of the markings. One preferred embodiment of the marking is a tattoo created with inks that are of a color so that they are not very noticeable under normal lighting conditions of a subject's skin, but can be seen distinctly under another type of light such as a “black light”. More preferably, these markings match or nearly match the color of the subject's skin. Another preferred embodiment of the marking is a small plastic disk with a permanent adhesive backing, which can be positioned as a marking on a subject, and can be removed with an appropriate solvent when the monitoring period is over. Still another preferred embodiment of the marking is a semi-permanent tattoo or inks that wear off after a given period of time, preferably several months. For purposes of this application, by semi-permanent it is meant that the marking will remain visible under the appropriate conditions on the subject over a reasonable period of time even after the subject washes or bathes. This reasonable period of time is preferably at least 2 days, more preferably is at least 7 days, even more preferably is at least 2 weeks, still even more preferably at least 1 month, still even more preferably is at least 3 months and most preferably is at least 6 months. Preferably, also the marking can fade or disappear, can be removed or covered in some fashion after the monitoring period is over [dk2] . Preferably, the marking is large enough to be seen by the person including the subject applying the electrodes but is small enough not to be highly visible to other individuals. Preferably, each marking has a surface area of between 0.001 and 2000 mm 2 , more preferably between 0.01 and 500 mm 2 , even more preferably between 0.25 and 100 mm 2 , still even more preferably between 0.25 and 50 m m2 , and most preferably between 0.25 and 5 mm 2 . The system of marking can be used for the present invention to place individual electrodes or to place a harness with multiple electrodes. An individual marking can be used by itself or with some other anatomical feature of the subject to place the one or more electrodes or the harness containing the electrodes. One example is a marker could be used along with the sternum (or breast bone) of the subject to place an electrode harness. Multiple markings allow for an even more accurate placement of the electrode(s) or electrode harness. Preferably, at least 2 markings are used for placement of electrodes or an electrode harness, more preferably at least 4 markings are used, even more preferably at least 6 markings are used, still even more preferably at least 8 markings are used, still even more preferably at least 10 markings are used and most preferably at least 12 markings are used [dk3] . Another step used in various embodiments of the present invention involves applying an electrode(s) (or the electrode harness containing an electrode) to the subject's outer layer of skin in reference to the marking. This can be done by the subject, a friend, a family member, a home healthcare provider or a medical professional. The markings, however, make it simpler for an unskilled individual to accurately apply the monitoring electrode(s) or electrode harness. The markings also make it quicker for a healthcare provider or medical professional to make the application. FIGS. 1-3 demonstrate the use of this marking system on a human subject. FIG. 1 is a schematic diagram showing one embodiment of the step of marking a subject under the method of the present invention. In FIG. 1 the subject 2 is 25 marked under or over the subject's outer layer of skin 6 using a device to create a permanent or semi-permanent mark. In this particular embodiment, the subject 2 actually has five marks 4 , 5 , 7 , 8 and 9 , which are placed on the subject's thorax. FIG. 2 is a schematic diagram showing an electrode array 12 with reference marks for alignment on the subject 2 shown in FIG. 1 . In the particular embodiment of the electrode array 12 in FIG. 2 , the electrode array 12 contains five reference marks 14 to be aligned with the permanent or semi-permanent marks 4 , 5 , 7 , 8 and 9 shown in FIG. 1 under or over the subject's 2 outer layer of skin 6 . The electrode array 12 , in this embodiment, further includes a connector 18 for connecting the electrode array to a processing or monitoring device (not shown), and flexible arms 16 to allow for positioning of the array 12 . The call-out 20 shows both a planar and a side view of one of the electrodes and corresponding reference mark of the electrode array 12 . FIG. 3 is a schematic diagram showing the electrode array 12 in FIG. 2 aligned to the markings 4 , 5 , 7 , 8 , and 9 on the subject 2 shown in FIG. 1 . It will be noted that the electrode array in FIG. 3 is aligned to the markings by being placed so as to cover (or be aligned over), to overlap or to touch the markings. In addition, in this embodiment the connector 18 for the electrode array 12 connects the electrode array 12 with a wireless monitoring and/or transmission device 32 for relaying the biopotential signal picked up from the subject 2 . It will be apparent to those skilled in the art that various modifications and variations can be made to the present invention without departing from the spirit and scope of the invention. Thus, it is intended that the present invention cover the modifications and variations of this invention provided they come within the scope of the appended claims and their equivalents.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention The invention relates to a receptacle for treatment of fluid materials and specially to a container which can be used for filtering, separating, and dispensing measured quantities of a liquid. In particular, the vessel of this invention is concerned with a beaker or cup having a bottom drain opening for gravity flow discharge. The device includes a companion sluice valve assembly for controlling the rate of discharge flow. A strainer basket is also incorporated for filtering incoming liquids. 2. Description of the Prior Art The utensil of this invention is designed to provide in one unit a measuring cup having the combined features and convenience of use previously not available in such devices. The improved design of this invention incorporates detachable component parts which can be disassembled for cleaning and replacement to provide trouble-free operation. A sluice valve assembly is adapted for a snap-fit or equivalent coupling attachment to an exterior portion of the cup. The valve assembly includes a valve housing and a slidable valve member which can be readily removed from within the housing. The significance of this structural arrangement of the valve assembly is particularly advantageous when the device is used as a kitchen utensil for food handling or in laboratory use wherein cleanliness and hygienic conditions are of particular importance. Additionally, since the valve assembly is readily accessible, it can be washed free of deposits of foreign matter which can interfere with its smooth and effective operation. In contrast, prior devices of this nature which have been patented, such as those shown in U.S. Pat. No. 954,346 or in U.S. Pat. No. 1,327,389, include valve mechanisms which form an integral part of the device and are not separately removable for maintenance or replacement. A disadvantage therefore of these patented devices is that it is more difficult to maintain sanitary conditions as, for example, by sterilization of the individual valve components. Further, routine maintenance is hampered when the valve is relatively inaccessible. Another problem with prior art devices is that it is difficult to obtain a smooth, steady, laminar flow through a discharge outlet as may be required for accurate measurement of the discharged material. This is overcome, in part, in the instant invention by the application of a strainer basket which is placed over the mouth of the cup. In addition, the strainer is adapted for receiving one of a plurality of apertured disc insets wherein each of the discs contains an apertured grid pattern for preventing different size particulate material from entering into the cup and thus contaminating the valve assembly or otherwise causing a blockage or interference with proper operation of the valve mechanism. In this connection and as a further feature, a sloped transverse wall surface has been provided for directing the liquid contents toward a centrally located outlet orifice for gravity flow discharge. The funnel-like surface increases the flow velocity and is believed to reduce sedimentation on the floor or bottom of the cup. This approach of incorporating a funnel shaped interior transverse wall surface in a device of this type for improving discharge flow characteristics has not previously been shown. BRIEF SUMMARY OF THE INVENTION The subject matter of the dispensing utensil of this invention includes a substantially cylindrical cup shaped vessel having an open mouth for receiving liquid materials and a sloped interior transverse wall surface for directing the contents toward a centrally located outlet orifice for gravity flow discharge of same. A sluice valve assembly is releasably attached to the cup in registration with the outlet orifice for selectively regulating the rate of discharge flow. The valve assembly includes a valve housing for accommmodating a slidable valve member. The nature of the invention is such that a smooth, uniform and laminar discharge flow can be controlled by the user's push-pull manipulation of a terminal end of the valve member. A constructional feature of this device is that the substantially cylindrical wall of the cup shaped vessel extends below the outlet orifice and forms a skirt enclosure which will support the dispensing utensil when placed on a horizontal surface. The sluice valve assembly is externally mounted to the cup and recessed within the skirt enclosure. A purpose of this device is for the separation of liquids having different specific gravities and can be applied in the culinary arts, for instance, to remove grease or fats from gravies or soups or for clarifying butter. The invention also incorporates a separable strainer basket which is suspendable within the mouth of the cup. The strainer basket is provided with an apertured disc inset wherein each of a plurality of such apertured discs is provided respectively with different size openings forming a grid pattern, and an appropriate disc can be selected in accordance with the materials to be separated or filtered from the inflowing liquid. The removal of such particulate materials is useful for eliminating impurities and also for preventing clogging of the valve mechanism. It should further be noted that the cup is provided with graduated markings to facilitate the determination of and to control the amount of liquid ingredients to be dispensed. In this connection, the utensil can be used for dispensing such food ingredients as pancake batter. In addition, the constituent components as provided for in a recipe can be quickly and easily dispensed with the device being used as a general purpose measuring cup. Having thus summarized the invention, it will be seen that an object thereof is to provide a dispensing utensil of the general character described herein which is not subject to the disadvantages of the prior art. Specifically, it is an object of the instant invention to provide a dispensing utensil having a cup shaped vessel with a valve controlled outlet orifice for regulating gravity discharge flow from the vessel. It is a further object of this invention to provide a dispensing utensil which can be held in one hand and the valve mechanism operated using the other hand to selectively control the quantity of liquid contents discharged. A still further object of this invention is to provide a dispensing utensil wherein the valve assembly is readily removable for cleaning and maintenance purposes. A further object of this invention is to provide a dispensing utensil having a strainer basket adapted to be seated over the mouth thereof wherein selected aperture disc insets can be used with the strainer basket for predetermining the size of particles to be filtered from the incoming liquid. Still another object of this invention is to provide a dispensing utensil having an interior transverse wall surface being sloped toward a centrally located outlet orifice for improving the discharge flow characteristics. The above and other objects, features and advantages of this invention will be apparent from the following description of the preferred embodiment when considered in connection with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS In the accompanying drawings in which are shown the preferred embodiments of the invention: FIG. 1 is a perspective view of the dispensing utensil of this invention with a portion being cut away to expose the sluice valve assembly; FIG. 2 is a sectional view taken substantially along line 2--2 of FIG. 1 and shows the dispensing utensil of this invention including the component strainer basket and sluice valve assembly mounted in registration with the outlet orifice and recessed within the skirt portion of the extended cup wall section; FIG. 3 is a sectional view taken substantially along line 3--3 of FIG. 2 and shows the sluice valve assembly including the valve housing and slidable valve member shown in an open position with a valve stem shown extending through the skirt portion of the cup wall; FIG. 4 is a partial sectional view shown to an enlarged scale indicating in detail the coupling arrangement between the outlet orifice and the valve housing; and FIG. 5 is a sectional view slightly enlarged and taken substantially along line 5--5 of FIG. 3 and shows the valve housing including the channel for receiving the gate closure portion of the slidable valve member. DETAILED DESCRIPTION OF THE INVENTION Referring now in detail to the drawings, the reference numeral 10 denotes generally a dispensing utensil as constructed in accordance with this invention. The dispensing utensil 10 as typically illustrated in FIGS. 1 and 2 appears as a beaker or cup shaped vessel having a substantially cylindrical body portion 12 which terminates at an upper end in a peripheral edge 14 defining a mouth opening for receiving a strainer basket 16. The peripheral edge 14 also forms a spout or pouring lip 18. A handle extension 20 is shown as being formed integrally with the body portion 12 and is angled as shown for comfortable gripping. The body portion 12 is provided with an interior transverse wall or intermediate surface 22 which is sloped gradually toward a centrally located outlet orifice 24. The funnel or frustoconical shaped intermediate surface 22 provides desired hydraulic characteristics for the outflow of liquids and has a constant gradient being in the range of 10°-20° from the horizontal and preferably approximately 15°. Discharge flow through the outlet orifice 24 is controlled by a sluice valve assembly 26, details of which will be more fully discussed hereinafter. As noted in the drawings, the body portion 12 extends at its lower end below the sloped intermediate surface 22 and forms a skirt 28 which surrounds and recesses the sluice valve assembly 26 and also provides a pedestal or base for stabilizing the cup and permitting free standing upon a horizontal support surface. The cup body 10 is preferably fabricated from a transparent material such as clear polycarbonate or Pyrex glass, and the sluice valve assembly 24 can be made of a high density polyethylene or equivalent material. Although the dimensions of the dispensing utensil 10 can be varied in accordance with the proposed use requirements, a 250 or 300 milliliter (approximately 8 or 10 ounce) capacity has been found to be adequate for most common usage within the kitchen. A series of graduations 30 such as hatch markings are inscribed on the body portion 12 corresponding to the volumetric capacity of the utensil 10, and, for example, a 250 milliliter capacity can be graduated with spaced divisions indicating 25 milliliter increments. The sluice valve assembly 26 includes a valve housing 32 having a discharge port 34 extending therethrough. The housing 32 is adapted for removable coupling to the cup body 12 with the discharge port 34 being in registration with the outlet orifice 24. A snap-fit watertight connection is provided between the valve housing 32 and cup body 12. In the embodiment shown this is accomplished by providing the outlet orifice 24 with a depending cylindrical extension 36 which carries a flexible sealing ring 38; a mating portion of the valve housing 32 has an internal diameter conforming to the external dimension of the extension 36 and is provided with a corresponding interior groove 40 for lockingly engaging the sealing ring 38 and providing a snap fitting. The sluice valve assembly 26 also includes a slidable valve member or stem 42 having a gate closure element 44 at one end. The valve member 42 extends through an opening 46 in the skirt 28 and terminates in a finger grip element 48 at the other end. The gate closure element 44 is adapted for slidable accommodation within a receiving channel 50 formed in the valve housing 32. The gate closure element 44 is slidably displaceable in varying degrees into or out of the discharge port 34 for controlling the rate of outflow and for terminating flow. In operation, the dispensing utensil 10 can be held in one hand by the handle 20; the other hand can be used to manually grasp the finger grip element 48 and to manipulate it through a push-pull action such as noted by the phantom lines in FIGS. 2 and 3. After the desired liquids have been discharged or conversely retained within the utensil 10, the gate closure element 44 is positioned to seal the discharge port 34, and the remaining contents can be poured utilizing handle 20 and lip 18. It is also contemplated that a compression spring can be placed over the valve stem 42 and between the skirt 28 and gate closure element 44. This will contain the gate closure element 44 in a normally closed position. It should be apparent that with a little dexterity and with the aid of graduations 30 the user can readily control and discharge a desired quantity of the liquid contents. Further, since the cup body 12 is transparent, visual observation of different colorations of the contents or of the division line between liquids of different specific gravities can be used for aiding in the separation of liquids as, for example, to remove fats or greases from gravies or soups. After use, the valve housing 32 can be detached and removed for cleaning or sterilization. The valve stem 42 can be readily passed through the opening 46, and the gate closure element 44 can be slid out from within channel 50. The strainer basket 16 provides for the filtering of the incoming liquids and can thus be used to remove undesirable particulate material or for preventing impurities from clogging or otherwise interfering with the operation of the sluice valve assembly 26. The strainer basket 16 includes a ring or retainer 52 which corresponds in diameter to the open mouth for complementary fit within cup body 12 and is designed for seating on edge 14. A selection of replaceable disc insets having different size openings or grid patterns such as disc 54 having apertures 56 forming a grid pattern can be respectively positioned and held in the retainer 52 as shown in FIG. 2. The strainer basket 16 can be removed after the inflow of liquids or prior to the pouring of the contents from the utensil 10 using lip 18. It should be noted that the dispensing utensil of this invention can be applicable for other uses than those herein described and can dispense a wide range of fluids or flowable granulated materials in measured quantities as may be required in industrial, commercial or laboratory situations. The above cited embodiment is intended as exemplary, and while it has described the invention with specific implementation thereof, other modifications and changes might be made in this embodiment as set forth and will be apparent to those skilled in the art. Furthermore, it should be understood that all material shown and described in the accompanying drawings is to be interpreted as illustrative and not in a limiting sense, and the invention should be considered as comprehensive of all of the same which come within the scope of the appended claims.

1a

FIELD OF THE INVENTION This invention relates generally to packages for planar substrates, and, more particularly, to packages for housing self-adhesive planar substrates, such as a self-adhesive bandages. BACKGROUND OF THE INVENTION A variety of planar substrates must be individually packaged to preserve cleanliness of the substrate. The most common such planar substrate is a self-adhesive bandage having opposed, adhesive-coated end portions and a sterile central pad portion. To preserve the sterility of the pad portion, such self-adhesive bandages are normally packaged in individual sealed "envelopes." Although such envelopes satisfactorily maintain the sterility of the bandage, there are several problems with the use of such envelopes. Firstly, the envelopes are frequently difficult to open. The most commonly used envelope, for example, requires tearing open the envelope using an internally attached piece of thread. Manipulating this piece of thread can be frustratingly difficult, especially if wearing protective gloves. Moreover, occasionally the internal attachment of the thread breaks--wholly disabling the opening mechanism. Secondly, once the envelope is opened, an additional problem is raised as to how to administer the bandage without soiling the sterile pad and without becoming entangled with the adhesive-coated ends. In almost all self-adhesive bandages on the market, the opposed adhesive-covered ends are protected with separate cover sheets. It can be exceedingly difficult to remove these cover sheets without contacting either the adhesive-covered ends or the sterile pad. The difficulty inherent in removing the protective sheets is magnified when the caregiver is wearing protective gloves. Typically, such gloves are made from a very thin material to which the adhesive on the bandage readily attaches. Accordingly, it can seem almost impossible to manipulate a simple self-adhesive bandage from package to patient by a caregiver wearing protective gloves. Accordingly, there is a need for a package which eliminates the above-described problems with the prior art. SUMMARY The invention satisfies this need. The invention is a combination of a planar substrate, such a self-adhesive bandage, and a package for housing that substrate. The substrate has a front side and a back side. On the front side of the substrate, there is a central portion (where can be disposed a sterile pad) and opposed first and second end portions, at least one having an adhesive coating disposed thereon. The package comprises a first package moiety and a second package moiety. The first package moiety comprises (i) a rearward sheet having an exterior side and an interior side, having opposed distal and proximal ends and having opposed first and second side edges and (ii) a forward sheet having an exterior side and an interior side, having opposed distal and proximal ends and having opposed first and second side edges, wherein the distal ends of the rearward and forward sheets of the first package moiety are sealed together, wherein the first side edges of the rearward and forward sheets of the first package moiety are sealed together and wherein the second side edges of the rearward and forward sheets of the first package moiety are sealed together, in each case with the interior sides of the rearward and forward sheets of the first package moiety facing one another, so that the first package moiety forms a first partial enclosure. The second package moiety comprises (i) a first rearward sheet having an exterior side and an interior side, having opposed distal and proximal ends and having opposed first and second side edges, and (ii) a forward sheet having an exterior side and an interior side, having opposed distal and proximal ends and having opposed first and second side edges, wherein the distal ends of the rearward and forward sheets of the second package moiety are sealed together, wherein the first side edges of the rearward and forward sheets of the second package moiety are sealed together and wherein the second side edges of the rearward and forward sheets of the second package moiety are sealed together, in each case with the interior sides of the rearward and forward sheets of the second package moiety facing one another, so that the second package moiety forms a second partial enclosure. The proximal end of each sheet includes a tip portion and an inward portion. The proximal end of at least one of the sheets in the first package moiety is folded and disposed with its exterior side in contact with an adhesive layer on the front side of the substrate. Similarly, the proximal end of at least one of the sheets in the second package moiety is folded and disposed with its exterior side in contact with an adhesive layer on the front side of the substrate. The two proximal ends of the rearward sheets of the first and second package moieties are sealed together and the two proximal ends of the forward sheets of the first and second package moieties are sealed together, so that the first and second package moieties cooperate to provide a sealed enclosure with the substrate disposed therein. The invention provides the caregiver with the unique ability to open the package, remove the sheets which protect the adhesive surfaces and apply the bandage to a patient in a one-step operation by merely grasping the package at opposite ends and gently pulling the first and second package moieties apart. This simple pulling apart of the package not only opens the package, but also automatically removes the protective sheets from the adhesive portions of the bandage. Finally, while continuing to grasp the opposite ends of the two package moieties, the bandage can be administered to a patient. There is no need to deal with a myriad of individual parts of the bandage package, and there is no risk of the caregiver contacting either with the sterile pad portion of the adhesive portions. DRAWINGS These features, aspects and advantages of the present invention will become better understood with regard to the following description, appended claims and accompanying figures where: FIG. 1 is a perspective view of a combination having features of the invention; FIG. 2 is a perspective view of the combination illustrated in FIG. 1, shown in partial disassembly, as during application; FIG. 3 is an exploded perspective view of the combination as shown in FIG. 1 having features of the invention; FIG. 4 is a schematic side view of the combination illustrated in FIG. 1; FIG. 5 is a schematic side view of the combination illustrated in FIG. 1 showing the two combination moieties drawn partially apart; FIG. 6 is a schematic side view of the combination illustrated in FIG. 1 showing the two combination moieties drawn further apart than shown in FIG. 5; FIG. 7 is a schematic side view of the combination illustrated in FIG. 1 showing the two combination moieties drawn further apart than shown in FIG. 6; FIG. 8 is a schematic side view of a self-adhesive bandage applied to a patient using the combination illustrated in FIG. 1; FIG. 9 is a schematic side view of a second combination having features of the invention; FIG. 10 is a schematic side view of the combination illustrated in FIG. 9 showing the two combination moieties drawn partially apart; FIG. 11 is a schematic side view of the combination illustrated in FIG. 9 showing the two combination moieties drawn further apart than shown in FIG. 10; FIG. 12 is a schematic side view of the combination illustrated in FIG. 9 showing the two combination moieties drawn further apart than shown in FIG. 11; FIG. 13 is a schematic side view of a self-adhesive bandage applied to a patient using the combination illustrated in FIG. 9; FIG. 14 is a schematic side view detail of a self-adhesive bandage and package having features of the invention; and FIG. 15 is a side view detail of an alternative self-adhesive bandage having features of the invention. DETAILED DESCRIPTION The following discussion describes in detail one embodiment of the invention and several variations of that embodiment. This discussion should not be construed, however, as limiting the invention to those particular embodiments. Practitioners skilled in the art will recognize numerous other embodiments as well. The invention is a combination 8 of a planar substrate 10 disposed within a unique package 12. As illustrated in the drawings and as hereinafter described, the planar substrate 10 is most typically a self-adhesive bandage. However, it will be appreciated by those skilled in the art that the planar substrate 10 can be other than a self-adhesive bandage. In all cases, the planar substrate 10 has a front side 14 and a back side 16. The front side 14 comprises a central portion 18 and opposed first and second end portions 20 and 22, respectively. Both the first and second end portions 20 and 22 each have a distal-most end 23 and 25, respectively. Disposed on the front side 14 of the substrate 12, and typically on each end portion 20 and 22, is an adhesive layer 24 suitable for adhering the planar substrate 10 to a target surface 26. Where the planar substrate 10 is a self-adhesive bandage, the central portion 18 includes a sterile pad 28 and the target surface 26 is the skin of a patient. The package 12 comprises a first package moiety 30 and a second package moiety 32. The first package 30 moiety includes a rearward sheet 34 having an exterior side 36 and an interior side 38, having opposed distal and proximal ends 40 and 42, respectively, and having opposed first and second side edges 44 and 46, respectively. The first package moiety 30 further includes a forward sheet 48 having an exterior side 50 and an interior side 52, having opposed distal and proximal ends 54 and 56, respectively, and having opposed first and second side edges 58 and 60, respectively. The proximal end 42 of the rearward sheet 34 of the first package moiety 30 has a tip portion 61 and an inward portion 63. Similarly, the proximal end 56 of the forward sheet 48 of the first package moiety 30 has a tip portion 65 and an inward portion 67. The distal ends 40 and 54 of the rearward and forward sheets of the first package moiety 30 are joined together at a first distal end joint 62 to provide a first package moiety distal end 69. The first side edges 44 and 58 of the rearward and forward sheets 34 and 48 of the first package moiety 30 are joined together at a first side edge joint 64, and the second side edges 46 and 60 of the rearward and forward sheets 34 and 48 of the first package moiety 30 are joined together at a second side edge joint 66. Each such joint 62, 64 and 66 can be accomplished, for example, by folding the sheets, by use of a permanent sealing adhesive or by use of a suitable heat sealing process. Each joint 62, 64 and 66 is made such that the interior sides 38 and 52 of the rearward and forward sheets 34 and 48 of the first package moiety face each other. After the joining of the distal ends 40 and 54 and the side edges 44 and 58, 46 and 60, the first package moiety 30 forms a first partial enclosure 68. The second package moiety 32 includes a rearward sheet 70 having an exterior side 72 and an interior side 74, having opposed distal and proximal ends 76 and 78, respectively, and having opposed first and second side edges 80 and 82, respectively. The second package moiety 32 further includes a forward sheet 84 having an exterior side 86 and an interior side 88, having opposed distal and proximal ends 90 and 92, respectively, and having opposed first and second side edges 94 and 96, respectively. The proximal end 78 of the rearward sheet of the second package moiety 32 has a tip portion 97 and an inward portion 99. Similarly, the proximal end 92 of the forward sheet 84 of the second package moiety 32 has a tip portion 101 and an inward portion 103. The distal ends 76 and 90 of the rearward and forward sheets 70 and 84 of the second package moiety 32 are joined together at a second distal end joint 98 to provide a second package moiety distal end 105. The first side edges 80 and 94 of the rearward and forward sheets 70 and 84 of the second package moiety 32 are joined together at a third side edge joint 100, and the second side edges 82 and 96 of the rearward and forward sheets 70 and 84 of the second package moiety 32 are joined at a fourth side edge joint 102. Each such joint 98, 100 and 102 can be accomplished, for example, by folding the sheets, by use of a permanent sealing adhesive or by use of a suitable heat sealing process. Each joint 98, 100 and 102 is made such that the interior sides 74 and 88 of the rearward and forward sheets 70 and 84 of the second package moiety 32 face each other. After the joining of the distal ends 76 and 90 and the side edges 80 and 94, 82 and 96, the second package moiety 32 forms a second partial enclosure 104. Typically, each of the sheets 34, 48, 70 and 84 in the first and second package moieties 30 and 32 are made from a non-woven material, such as a paper or flexible plastic material. The proximal end 42 and/or 56 of at least one of the sheets 34 and 48 of the first package moiety 30 is folded and disposed with its exterior side 36 and/or 50 in contact with the adhesive layer 24 on the front side 14 of the substrate 10. Similarly, the proximal end 78 and/or 92 of at least one of the sheets 70 and 84 of the second package moiety 32 is folded and disposed with its exterior side 72 and/or 86 in contact with an adhesive layer 24 on the front side 14 of the substrate 10. FIGS. 1-8 illustrate one embodiment of the invention. In this embodiment, the proximal end 56 of the forward sheet 48 of the first package moiety 30 is folded and disposed with its exterior side 50 in contact with the adhesive layer 24 on the front side 14 of the first end portion 20 of the substrate 10. Also in this embodiment, the proximal end 92 of the forward sheet 84 of the second package moiety 32 is folded and disposed with its exterior side 86 in contact with the adhesive layer 24 on the front side 14 of the second end portion 22 of the substrate 10. FIGS. 9-13 illustrate a second embodiment of the invention. In this embodiment, the proximal end 42 of the rearward sheet 34 of the first package moiety 30 is folded and disposed with its interior side 38 in contact with the adhesive layer 24 on the front side 14 of the first end portion 20 of the substrate 10. Also in this embodiment, the proximal end 92 of the forward sheet 84 of the second package moiety 32 is folded and disposed with its exterior side 86 in contact with the adhesive layer 24 on the front side 14 of the second end portion 22 of the substrate 10. In all embodiments, the two proximal ends 42 and 78 of the rearward sheets 34 and 70 of the first and second package moieties 30 and 32 are joined together at a rearward proximal end joint 106, and the two proximal ends 56 and 92 of the forward sheets 48 and 84 of the first and second package moieties 30 and 32 are joined together at a forward proximal end joint 107. Thus, the first and second package moieties 30 and 32 cooperate to provide an enclosure 108 with the substrate 10 disposed therein. In the embodiment illustrated in FIGS. 1-8, the two proximal ends 42 and 78 of the rearward sheets 34 and 70 of the first and second moieties 30 and 32 are joined together near their proximal-most ends 109 and 110, respectively. Preferably, the proximal-most ends 109 and 110 of one of the rearward sheets 34 or 70 is folded at a fold 112 so that the interior surfaces 38 and 74 of the two proximal-most ends 109 and 110 are joined together. Also in the embodiment illustrated in FIGS. 1-8, the inward portions 67 and 103 of the proximal ends 56 and 92 of the forward sheets 48 and 84 are joined together. Each proximal end 56 and 92 of the forward sheets 48 and 84 is folded so that the exterior sides 50 and 86 of both proximal ends 56 and 92 of the forward sheets 48 and 84 can be disposed in contact with the adhesive layer 24 on the front side 14 of the substrate 10. In this embodiment, the proximal ends 56 and 92 of the forward sheets 48 and 84 are joined together at their respective inward portions 67 and 103, such that the external sides 50 and 86 of the two inward portions 67 and 103 of the proximal ends 56 and 92 of the forward sheets 48 and 84 are joined together. In the embodiment illustrated in FIGS. 9-13, one of the proximal ends 42 or 78 of the rearward sheets 34 or 70 is folded so that the proximal end 42 or 78 of that sheet 34 or 70 can be disposed in contact with the adhesive layer 24 on the front side 14 of the substrate 10. The joining of both the rearward sheets 34 and 70 and the forward sheets 36 and 72 is accomplished by joining the tip portion 61 or 97 of one of the proximal ends 42 or 78 to the inward portion 63 or 99 of the other proximal end 42 or 78. Preferably, the forward proximal end joint 107 is made such that the exterior sides 36 and 72 of both sheets 34 and 70 are joined together. In all embodiments, it is also preferable that the proximal ends 42 and 78 of the rearward sheets 34 and 70 of the first and second package moieties 30 and 32 and the proximal ends 56 and 92 of the forward sheets 48 and 84 of the first and second package moieties 30 and 32 are both joined together by folding, by use of a low tack adhesive or by some similar reversible joining mechanism. This allows the joints 106 and 107 between the proximal ends 42 and 78 of the rearward sheets 34 and 70 and the forward sheets 48 and 84 to be easily and gradually broken by gently pulling on opposite distal ends 69 and 105 of the first and second package moieties 30 and 32. In a still further preferred embodiment, one of the tip portions 61 or 65 of the proximal ends 42 and 56 of the sheets 34 or 48 of the first package moiety 30 is folded so that a tab 114 is formed at the end of each tip portion 61 or 65. Likewise, in this still preferred embodiment, one of the tip portions 97 or 101 of the proximal ends 78 and 92 of the sheets 70 and 84 of the second package moiety 32 is folded so that a tab 114 is formed at the end of each tip portion 97 or 101. Each tab 114 is between about 1 mm and about 10 mm long. Each tab 14 is disposed in contact with the adhesive layer 24 on the front side 14 of the substrate 10 at opposite end portions of the substrate 10. This feature is illustrated in each of the drawings, but is most easily seen in FIG. 14. In the embodiment illustrated in FIG. 14, the entire interior side 88 of the forward sheet 84 is coated with a high adherence material 116, such as polyethylene. Conversely, the entire exterior side 86 of the forward sheet 84 is coated with a low adherence layer 117, such as a non-stick fluorocarbon, such as Teflon® brand materials manufactured and sold by the DuPont Chemical Company of Wilmington, Del. The high adherence layer 116 has little propensity to adhere to itself, but does strongly adhere to the adhesive layer 24 on the front side 14 of the substrate 10. The low adherence layer 117, on the other hand, adheres to a much lesser extent to the adhesive layer 24. In the preferred embodiment illustrated in FIG. 14, the only material in contact with the adhesive layer 24 is the low adherence layer 117, except for the high adherence layer 116 on the tab 114. By this design, the forward sheet 84 can be readily peeled away from the adhesive layer 24 until the only contact between the adhesive layer 24 and the forward sheet 84 is the tab 114. Pulling the tab 114 away from the adhesive layer 24 requires a modestly sharp tug on the distal end 90 of the forward sheet 84. In embodiments wherein the high adherence layer 116 is polyethylene, the side edges 44, 46, 58 and 60 and the distal ends 69 and 105 of the first and second package moieties 30 and 32 can be heat-sealed by heating the polyethylene at the respective side edges and distal ends, whereupon the opposed polyethylene layers 116 rigidly adhere to one another. In a typical embodiment, the width of the substrate 10 is about 0.75 inches and the package 12 has a width of about 1.25 inches. Accordingly, approximately 0.125 inches along each side edge 44, 46, 58 and 60 can be heat-sealed in the manner described above. This tab feature provides additional assurance that the distal-most ends 23 and 25 of the adhesive-covered end portions 20 and 22 of the substrate 10 will remain in firm contact with the tip portion of a sheet within each package moiety 30 and 32 during application of the substrate 10 to the target surface 26 (as illustrated in FIGS. 7 and 12). The tabs 114 can only be pulled away from the distal-most ends 23 and 25 of the substrate 10 in a synchronized "high force" release which frees both tabs 114 simultaneously. Without this feature, the distal-most ends 23 and 25 of one or both of the adhesive-covered ends 20 and 22 of the substrate 10 might prematurely disengage from its respective package moiety 30 or 32 during application of the substrate 10. FIG. 15 illustrates an alternative embodiment (alternative to the preferred embodiment illustrated in FIG. 14). In the embodiment illustrated in FIG. 15, instead of the tip portions 61 or 65 and 97 or 101 being folded over to provide tabs 114, the tip portions 61 or 65 and 97 or 101 are disposed flat against the adhesive layer 24. To provide a synchronized "high force" release similar to that provided by the embodiment illustrated in FIG. 14, the tip portions 61 or 65 and 97 or 101 in the embodiment illustrated in FIG. 15 are provided with a high adherence surface relative to the non-tip surface disposed against the adhesive layer 24. Such high adherence surface can be provided by selectively coating the tip portions 61 or 65 and 97 or 101 with a high adherence layer 116, such as polyethylene. Alternatively, the high adherence surface can be provided as illustrated in FIG. 15 by merely leaving the tip portions 61 or 65 and 97 or 101 wholly uncoated and coating the non-tip portions with a low adherence layer 117. In operation, the package 12 of the invention can be conveniently opened and the substrate 10 applied to the target surface 26 in one continuous operation--by merely gripping the opposed distal ends 69 and 105 of the package 12 and gently pulling those two distal ends 69 and 105 apart. In the embodiment illustrated in FIGS. 1-8, this operation is easily seen by reference to FIGS. 4-8. In the embodiment illustrated in FIGS. 9-13, this operation is easily seen by reference to FIGS. 9-13. FIGS. 4 and 9 represent the two different embodiments of the package 12 before opening is commenced. In FIGS. 5 and 10, the user grips the opposed distal ends 69 and 105 of the package 12 and begins to gently pull outwardly on those two distal ends 69 and 105. The easily broken joints 106 and 107 are gradually broken. The user then continues to gradually pull the opposed distal ends 69 and 105 further apart as illustrated in FIGS. 6 and 11. As the user does so, the proximal ends of each sheets from the two package moieties 30 and 32 which are in contact with the adhesive layer 24 on the substrate 10 are gradually pulled away from the adhesive layer 24. The user ceases to pull on the distal ends 69 and 105 of the package 12 when the only contact between the package moieties 30 and 32 and the substrate 10 is provided by contact with a tab 114 from one of the sheets of each package moiety 30 and 32 (as illustrated in FIGS. 7 and 12). The user then, while holding the opposed distal ends 69 and 105 with the substrate 10 and package moieties 30 and 32 construed as shown in FIGS. 7 and 12, applies the substrate 10 to the target surface 26. Thereafter, the user pulls slightly further on the opposed distal ends 69 and 105 of the package 12 until both package moieties 30 and 32 are fully disengaged from the substrate 10 (as illustrated in FIGS. 8 and 13). Having thus described the invention, it should be apparent that numerous structural modifications and adaptations may be resorted to without departing from the scope and fair meaning of the instant invention as set forth hereinabove and as described hereinbelow by the claims.

1a

REFERENCE TO RELATED APPLICATIONS [0001] This application claims the priority of United Kingdom Application No. 1122162.9, filed Dec. 22, 2011, the entire contents of which are incorporated herein by reference. FIELD OF THE INVENTION [0002] The invention relates to a vacuum cleaner, particularly of the handheld type of vacuum cleaner being generally compact and lightweight. The invention also relates to a filter for such a vacuum cleaner. BACKGROUND OF THE INVENTION [0003] Handheld vacuum cleaners are popular with users due to their light weight and inherent portability, as well as the lack of power cords, which makes such vacuum cleaners particularly convenient for spot cleaning tasks as well as for cleaning larger areas. The cleaning efficiency of handheld vacuum cleaners is improving and it is known to equip a handheld vacuum cleaner with a cyclonic separating apparatus to separate the dirt and dust from the incoming flow of dirt laden air. One such example is disclosed in EP2040599B, which incorporates a first cyclonic separating stage in the form of a relatively large cylindrical cyclone chamber and a second cyclonic separating stage in the form of a plurality of smaller cyclones fluidly downstream from the first cyclonic separating stage. In such an arrangement, the first cyclonic separating stage works to separate relatively large debris from the airflow, whilst the second cyclonic separating stage filters relatively fine dirt and dust from the airflow by virtue of the increased separation efficiency of the smaller cyclones. [0004] Whilst two-stage cyclonic separation is efficient at separating dirt and dust from the incoming airflow, it is still prudent to provide a filter downstream of the cyclonic separating apparatus and upstream of the motor in order to protect the motor from the ingress of fine dust which may still be entrained in the airflow. EP2040599B includes a generally planar filter member that is located in a recess adjacent an outlet duct of the cyclonic separating unit. The plane of the filter member lies generally parallel to the longitudinal axis of the cyclonic separating unit. Although this configuration permits a relatively large filter to be used, the overall size of the vacuum cleaner is increased significantly. It is with this drawback in mind that the invention has been devised. SUMMARY OF THE INVENTION [0005] The invention provides a vacuum cleaner comprising a cyclonic separating apparatus including a dirty air inlet, a main body connected to the cyclonic separating apparatus and a motor and fan unit for generating an airflow through the cyclonic separating apparatus from the dirty air inlet to a clean air outlet, wherein the cyclonic separating apparatus includes at least a first cyclonic cleaning stage and an elongate filter arranged fluidly downstream from the first cyclonic cleaning stage. The elongate filter is housed in a duct at least partially surrounded by the first cleaning stage, and comprises an inlet portion carrying a filter portion defining a filter chamber. The inlet portion includes one or more radial inlets to permit air to flow into the inlet portion in a radial direction, wherein the air flows from the inlet portion to the filter chamber in an axial direction. [0006] Preferably, the filter is a sock filter arranged in the duct and so is generally tubular and defines a filter wall having a longitudinal axis generally parallel with a longitudinal axis of the duct/separating apparatus. Commonly, elongate filters such as sock filters are arranged such that air flow enters the interior or lumen of the filter in a direction along the longitudinal axis of the filter, through the open end of the filter. Such a configuration requires a chamber adjacent the open end of the filter to define the entry zone and allow air to flow in an axial direction in to the filter. Conversely, in the invention, the filter defines one or more radial inlets so that airflow is directed into the interior of the filter in a radial direction, that is to say in a direction normal to the longitudinal axis of the filter, thereby avoiding the need for a chamber adjacent the open end of the sock filter as in conventional arrangements. This enables the housing of the filter i.e. the surrounding part of the duct and the separating apparatus to be more compact, which is beneficial in particular for handheld vacuum cleaners for which important characteristics are compactness and low weight. [0007] Various configuration of radial inlets are possible. For example, the radial inlet may be a single annular opening extending either partly or wholly about the circumference of the inlet portion. Alternatively, the inlet portion may have a plurality of inlets spaced angularly around the periphery of the inlet portion. A plurality of inlet apertures may improve the air flow through the filter and so reduces pressure drop. In the case of a plurality of inlet apertures, each aperture may be aligned with a respective air channel or ‘vortex finger’ defined by a cyclone outlet manifold of the separating apparatus. Once the airflow has entered the interior of the filter, due to the configuration of the filter the air flows radially outwards through the wall of the filter media portion. [0008] In order to improve accessibility of the filter, the inlet portion may define a filter cap that is engageable within a complementary shaped aperture defined by the separating apparatus such that the filter cap defines an outer surface of the cyclonic separating apparatus. In this way, the user is able to grip the top of the filter and remove it from the separating apparatus without removing the separating apparatus from the main body of the vacuum cleaner. The filter may therefore extend along the duct from a point above the cyclonic separating apparatus to a point below the first cyclonic cleaning stage and near to the base of the separating apparatus. [0009] The separating apparatus may include a second cyclonic cleaning stage arranged fluidly downstream of the first cyclonic cleaning stage. In such a configuration, the filter may be configured such that the first cyclonic cleaning stage, the second cyclonic cleaning stage and the filter may be concentric about a common axis. [0010] The invention is applicable to upright and cylinder type vacuum cleaner, but is particularly suited to handheld vacuum cleaners due to the packaging benefits it provides particularly in terms of size and weight of the separating apparatus. [0011] From another aspect, the invention provides a filter for a vacuum cleaner comprising a generally tubular inlet portion carrying a generally tubular filter media portion defining an interior chamber having an axis, the inlet portion including one or more radially facing inlets such that a radial air path is defined for air to flow into the inlet portion and an axial air flow path is defined for air to flow from the inlet portion to the filter chamber. [0012] In a second aspect, the invention resides in a vacuum cleaner comprising a cyclonic separating apparatus including a dirty air inlet, a main body connected to the cyclonic separating apparatus and a motor and fan unit for generating an airflow through the cyclonic separating apparatus from the dirty air inlet to a clean air outlet. The cyclonic separating apparatus includes at least a first cyclonic cleaning stage and an elongate filter arranged fluidly downstream from the first cyclonic cleaning stage, the elongate filter being housed in a duct at least partially surrounded by the first cleaning stage. The filter comprises an inlet portion and a filter portion, the inlet portion including one or more inlets to permit air to flow into the inlet portion, wherein the inlet portion includes a cover portion that is receivable in the separating apparatus such that the cover portion defines at least a part of an outer surface of the separating apparatus. [0013] Such an arrangement improves the accessibility of the filter, since a user can simply grip the top of the filter and remove it from the separating apparatus without removing the separating apparatus from the main body of the vacuum cleaner. The filter may therefore extend along the duct from a point above the cyclonic separating apparatus to a point below the first cyclonic cleaning stage and near to the base of the separating apparatus. [0014] In order to improve the sealing of the filter within the separating apparatus and prevent ambient air from bleeding into the filter duct or unfiltered air from entering the filter duct, the inlet portion may include a first sealing member above the one or more inlets and a second sealing member below the one or more inlets. The first sealing member may be provided about the periphery of the cover portion so as to seal against a complementary shaped aperture in an exhaust manifold of the separating apparatus. [0015] The vacuum cleaner may also include a second cyclonic cleaning stage located downstream of the first cyclonic cleaning stage, the second cyclonic cleaning stage comprising a plurality of cyclones arranged fluidly in parallel about an axis, and wherein the duct is in communication with an outlet passage which extends between two of the cyclones in the second cyclonic cleaning stage and defines an outlet port which is centred on an axis that is orthogonal with the axis of the second cyclonic cleaning stage. Such an arrangement provides a height reduction benefit for the separating apparatus since the outlet extends rearwardly and between a gap defined between two of the cyclones of the second cyclonic separation stage instead of air being exhausted from the top of the apparatus. [0016] It should be noted that preferred and/or optional features of the first aspect of the invention can be combined with second aspect of the invention, and vice versa. BRIEF DESCRIPTION OF THE DRAWINGS [0017] Embodiments of the present invention will now be described, by way of example only, with reference to the accompanying drawings, in which: [0018] FIG. 1 is a side view of a handheld vacuum cleaner in accordance with the invention; [0019] FIG. 2 is a view from above of the vacuum cleaner of FIG. 1 ; [0020] FIG. 3 is a vertical section through the separating apparatus along line A-A in FIG. 2 ; [0021] FIG. 4 is an exploded perspective view of the separating apparatus of the vacuum cleaner in FIGS. 1 and 2 ; [0022] FIG. 5 is a view looking down into the cyclones of the separating apparatus; and [0023] FIG. 6 is a perspective view of an embodiment of a vortex finder member of the separating apparatus. DETAILED DESCRIPTION OF THE INVENTION [0024] Referring firstly to FIGS. 1 and 2 , a handheld vacuum cleaner 2 has a main body 4 which houses a motor and fan unit (not shown) above a generally upright handle or grip portion 6 . The lower end 6 a of the handle 6 supports a generally slab-like battery pack 8 . A set of exhaust vents 10 are provided on the main body 4 for exhausting air from the handheld vacuum cleaner 2 . [0025] The main body 4 supports a cyclonic separating apparatus 12 that functions to remove dirt, dust and other debris from a dirt-bearing airflow drawn into the vacuum cleaner by the motor and fan unit. The cyclonic separator 12 is attached to a forward part 4 a of the main body 4 and an air inlet nozzle 14 extends from a forward portion of the cyclonic separator that is remote from the main body 4 . The air inlet nozzle 14 is configured so that a suitable brush tool can be removably mounted to it and includes a catch 16 for securely holding such a brush tool when the tool is engaged with the inlet. The brush tool is not material to the present invention and so is not shown here. [0026] The cyclonic separating apparatus 12 is located between the main body 4 and the air inlet nozzle 14 and so also between the handle 6 and the air inlet nozzle 14 . The separating apparatus 12 has a longitudinal axis Y which extends in a generally upright direction so that the handle 6 lies at a shallow angle to the axis Y. [0027] The handle 6 is oriented in a pistol-grip formation which is a comfortable interface for a user since it reduces stress on a user's wrist during cleaning. The separating apparatus 12 is positioned close to the handle 6 which also reduces the moment applied to the user's wrist when the handheld vacuum cleaner 2 is in use. The handle 6 carries an on/off switch in the form of a trigger 18 for turning the vacuum cleaner motor on and off. In use, the motor and fan unit draws dust laden air into the vacuum cleaner 12 via the air inlet nozzle 14 . Dirt and dust particles entrained within the air flow are separated from the air and retained in the separating apparatus 12 . The cleaned air is ejected from the rear of the separating apparatus 12 and conveyed by a short duct to the motor and fan unit located within the main body 4 , and is subsequently expelled through the air outlets 10 . [0028] The separating apparatus 12 forming part of the handheld vacuum cleaner 2 is shown in more detail in FIG. 3 which is a cross section through the separating apparatus 12 along the line A-A in FIG. 2 , and FIG. 4 which shows an exploded view of the components of the separating apparatus 12 . In overview, the separating apparatus 12 comprises a first cyclonic separating unit 20 and a second cyclonic separating unit 22 located downstream from the first cyclonic separating unit 20 . In this example, the first cyclonic separating unit 20 extends about part of the second cyclonic separating unit 22 . [0029] It should be appreciated that the specific overall shape of the separating apparatus can be varied according to the type of vacuum cleaner in which the separating apparatus is to be used. For example, the overall length of the separating apparatus can be increased or decreased with respect to the diameter of the separating apparatus 12 . [0030] The separating apparatus 12 comprises an outer bin 24 defined by an outer wall being substantially cylindrical in shape and which extends about a longitudinal axis Y of the separating apparatus 12 . The outer bin 24 is preferably transparent so that components of the separating apparatus 12 are visible through it. [0031] The lower end of the outer bin 24 is closed by a bin base 26 that is pivotably attached to the outer wall 24 by means of a pivot 28 and held in a closed position by a catch 30 . Radially inward of and coaxial with the outer wall 24 is a second cylindrical wall 32 so that an annular chamber 34 is defined between the two walls. The second cylindrical wall 32 engages and is sealed against the base 26 when it is closed. The upper portion of the annular chamber 34 forms a cylindrical cyclone of the first cyclonic separating unit 20 and the lower portion of the annular chamber forms a dust collecting bin of the first cyclonic separating unit 20 . [0032] A bin inlet 36 is provided at the upper end of the chamber 34 for receiving an air flow from the air inlet nozzle 14 . Although not shown in the Figures, the bin inlet 36 is arranged tangentially to the chamber 34 so as to ensure that incoming dirty air is forced to follow a helical path around the chamber 34 . [0033] A fluid outlet is provided in the outer bin in the form of a generally cylindrical shroud 38 . More specifically, the shroud has an upper frusto-conical wall 38 a that tapers towards a lower cylindrical wall 38 b that depends downwardly into the chamber 34 . A skirt 38 c depends from the lower part of the cylindrical wall and tapers outwardly in a direction towards the outer wall 24 . The lower wall 38 c of the shroud is perforated therefore providing the only fluid outlet from the chamber 34 . [0034] A second annular chamber 40 is located behind the shroud 38 and provides a manifold from which airflow passing through the shroud 38 from the first separating unit 20 is fed to the second cyclonic separating unit 22 through a plurality of conduits or channels 74 defined by a centrally positioned cyclone support structure 42 . The second cyclonic separating unit 22 comprises a plurality of cyclones 50 arranged fluidically in parallel to receive air from the first cyclonic separating unit 20 . In this example, the cyclones 50 are substantially identical in size and shape, each comprising a cylindrical portion 50 a and a tapering portion 50 b depending downwardly therefrom (only one cyclone is labelled in FIG. 3 for clarity). The cylindrical portion 50 a comprises an air inlet 50 c for receiving fluid from one of the channels 74 . The tapering portion 50 b of each cyclone is frusto-conical in shape and terminates in a cone opening 52 at its bottom end through which dust is ejected, in use, into the interior of the cyclone support structure 42 . An air outlet in the form of a vortex finder 60 is provided at the upper end of each cyclone 50 to allow air to exit the cyclone. Each vortex finder 60 extends downwardly from a vortex finder member 62 as will be explained. [0035] As is shown clearly in FIGS. 3 and 4 , the cyclones of the second cyclonic separating unit 22 are grouped into a first set of cyclones 70 and a second set of cyclones 72 . Although not essential to the invention, in this embodiment the first set of cyclones 70 contains more cyclones (ten in total) than the second set of cyclones 72 (five in total). [0036] Each set of cyclones 70 , 72 is arranged in a ring which is centred on a longitudinal axis Y of the separating unit. The first set of cyclones 70 has a greater number so this forms a relatively large ring of cyclones into which the second set of cyclones is partially received or ‘nested’. Note that FIG. 4 depicts the first and second set of cyclones in an exploded view for clarity, whilst FIG. 3 shows the relative positioning of the first and second sets of cyclones when in a nested, but axially spaced, position so that the second set of cyclones can be considered to be ‘stacked’ on the first set of cyclones. [0037] Each cyclone 50 of both sets has a longitudinal axis C which is inclined downwardly and towards the longitudinal axis Y of the outer wall 52 . However, to enable a greater degree of nesting of the second set of cyclones into the first set of cyclones, the longitudinal axes C 2 of the second set of cyclones 72 are all inclined at to the longitudinal axis Y of the outer wall at a shallower angle than the longitudinal axes C 1 of the first set of cyclones 70 . [0038] Referring now to FIG. 5 , and specifically the outer ring defined by the first set of cyclones 70 , it can be seen that the cyclones are arranged into subsets 70 a which each comprise at least two cyclones. In this example, each subset of cyclones comprises an adjacent pair of cyclones so that the first set of cyclones 70 is divided into five subsets of cyclones 70 a, one subset of which 70 b are spaced apart more than the others. Within each subset, the cyclones 70 a are arranged so that the air inlets 50 c are located opposite to each other. The cyclone subset 70 b located that the rear of the separating apparatus 12 are spaced apart to allow the passage of an exhaust duct 94 , as will be explained. [0039] In this example, each subset of cyclones 70 a, 70 b is arranged to receive air from a respective one of the plurality of channels 74 defined by the cyclone support structure 42 which channel airflow from the annular chamber 40 located behind the shroud 38 to the air inlets 50 c of respective cyclones. [0040] It will also be noted from FIG. 5 that the cyclones 50 in the second set of cyclones 72 are arranged also in a ring-like pattern and distributed annularly such that each cyclone is positioned between an adjacent pair of cyclones in the first set of cyclones 70 . Furthermore, the respective inlets 50 c of the second set of cyclones are oriented to face a respective one of the channels 74 that feed air also to the first set of cyclones 70 . Since the air inlets 50 c of both the first and second sets of cyclones are fed air from a channel 74 that leads from the same annular chamber 40 , the first and second sets of cyclones can be considered to be fluidly in parallel. [0041] Turning once again to FIGS. 3 and 4 , the vortex finders 60 are defined by a short cylindrical tube that extends downwardly into an upper region of a respective cyclone 50 . Each vortex finder 60 leads into a respective one of a plurality of radially distributed air channels or ‘vortex fingers’ 80 defined by an exhaust plenum or manifold 82 located at the top of the separating apparatus 12 that serves to direct air from the outlets of the cyclones to a central aperture 84 of the manifold 82 . The aperture 84 constitutes the upper opening of a central duct 88 of the separating apparatus into which a filter member 86 is received. In this embodiment, the filter member 86 is an elongate tubular filter or ‘sock filter’ that extends down into the central duct 88 along the axis Y, and is delimited by a third cylindrical wall 90 defined by the cyclone supporting structure 42 . [0042] The third cylindrical wall 90 is located radially inwardly of the second cylindrical wall 32 and is spaced from it so as to define a third annular chamber 92 . An upper region of the cyclone support structure 42 provides a cyclone mounting arrangement 93 to which the cone openings 52 of the cyclones of the second cyclonic separating 22 are mounted so that they communicate with the interior of the support structure 42 . In this way, in use, dust separated by the cyclones 50 of the second cyclonic separating unit 22 is ejected through the cone openings 52 and collects in the third annular chamber 92 . The chamber 92 therefore forms a dust collecting bin of the second cyclonic separating unit 22 that can be emptied simultaneously with the dust collecting bin of the first cyclonic separating unit 20 when the base 26 is moved to an open position. [0043] During use of the vacuum cleaner, dust laden air enters the separating apparatus 12 via the bin inlet 36 . Due to the tangential arrangement of the bin inlet 36 , the dust laden air follows a helical path around the outer wall 24 . Larger dirt and dust particles are deposited by cyclonic action in the first annular chamber 34 and collect at the bottom of the chamber 34 in the dust collecting bin. The partially-cleaned dust laden air exits the first annular chamber 34 via the perforated shroud 38 and enters the second annular chamber 40 . The partially-cleaned air then passes into the air channels 74 of the cyclone support structure 42 and is conveyed to the air inlets 50 c of the first and second sets of cyclones 70 , 72 . Cyclonic separation is set up inside the two sets of cyclones 70 , 72 in order to separate the relatively fine dust particles still entrained within the airflow. [0044] The dust particles separated from the airflow by the first and second set of cyclones 70 , 72 are deposited in the third annular chamber 92 , also known as a fine dust collector. The further cleaned air then exits the cyclones via the vortex finders 60 and passes into the manifold 82 , from which the air enters the sock filter 86 in the central duct 88 and from there passes into the exhaust duct 94 of the cyclone separator whereby the cleaned air is able to exit the separating apparatus. [0045] As can be seen in FIGS. 3 and 4 , the filter 86 comprises an upper mounting portion 86 a and lower filter portion 86 b that carries out the filtering function and so is formed from a suitable mesh, foam or fibrous filter media. The upper mounting portion 86 a supports the filter portion 86 b and also serves to mount the filter 86 within the duct 88 by engaging with the aperture 84 of the exhaust manifold 82 . The mounting portion 86 a defines a circular outer rim that carries a sealing member 96 , for example in the form of an o-ring, by which means the mounting portion is received removably, but securely, within the aperture 84 of the manifold, simply by way of a press fitting. Since the mounting portion 86 a is circular, there is no restriction on the angular orientation of the filter, which aids a user in relocating the filter. Although not shown here, it should be appreciated that the filter 86 could also be provided with a locking mechanism if it is desired to more securely hold the filter in position. For example, the filter mounting portion 86 a could carry a twist-lock fitting formation so that the filter could be twisted in a first direction to lock it into position within the aperture 84 , and twisted in the opposite direction to unlock the filter. [0046] The mounting portion 86 a also includes an annular upper section provided with apertures or windows 100 distributed around its circumference, the apertures 100 providing an airflow path for air to enter the interior of the filter member 86 . The sealing member 96 prevents airflow from entering into the region of the filter from outside of the separating apparatus. Beneficially, the apertures 100 are distributed angularly around the periphery of the mounting portion 86 a and are arranged so as to be in line with a respect one of the radially distributed vortex fingers 80 of the manifold 82 which means that air can flow substantially uninterrupted from the ends of the vortex fingers 80 into a neighbouring one of the inlet apertures 100 of the filter 86 . Air therefore flows into the filter 86 in a radial direction through the apertures 100 , following which the air flows down the interior of the filter 86 and then exits through the cylindrical filter media in a radial direction. A second sealing element 97 , also in the form of an o-ring, is located in an annular groove on the exterior of the mounting portion 86 a thus extending circumferentially about the mounting portion thereby preventing air from flowing down the side of the filter from the inlet section. [0047] After flowing out of the filter 86 , the cleaned air then travels up the outlet passage 94 and exhausts the separating apparatus 12 via an exit port 101 located at the rear of the separating unit. It should be noted that the outlet passage 94 is shaped so as have a generally inclined orientation relative to the central axis Y of the duct 88 and rises to a position so that it lies between the two rearmost cyclones on the first set of cyclones 70 . [0048] The exit port 101 of the outlet passage 94 is oriented generally horizontally and rearwardly from the separating apparatus 12 and is aligned on an axis 103 that is substantially orthogonal to the longitudinal axis Y of the separating apparatus 12 . [0049] This configuration of airflow inlet enables the housing of the filter to be more compact since the alternative of allowing air to flow into the filter 86 in an axial direction requires a chamber above the inlet end of the filter to direct air into the top of the filter. The filter of the invention therefore avoids the need for such a chamber which enables the filter housing to be reduced in height. [0050] Having described the general function of the separating apparatus 12 , the skilled reader will appreciate it includes two distinct stages of cyclonic separation. First, the first cyclonic separating unit 12 comprises a single cylindrical cyclone 20 having a relatively large diameter to cause comparatively large particles of dirt and debris to be separated from the air by virtue of the relatively small centrifugal forces. A large proportion of the larger debris will reliably be deposited in the dust collecting bin 34 . [0051] Second, the second cyclonic separating unit 22 comprises fifteen cyclones 50 , each of which has a significantly smaller diameter than the cylindrical first cyclone unit 20 and so is capable of separating finer dirt and dust particles due to the increased speed of the airflow therein. The separation efficiency of the cyclones is therefore considerably higher than that of the cylindrical first cyclone unit 20 . [0052] Reference will now be made also to FIG. 6 which shows the vortex finder member 62 in more detail. The vortex finder member 62 is generally plate-like in form and performs two main functions. Its primary function is to provide a means by which air is channelled out of the cyclones 50 on an upwardly spinning column of air and thereafter to direct the airflow exiting the cyclones 50 to an appropriate zone on the adjacent exhaust manifold 82 . Secondly, it serves to seal to upper end of the cyclones 50 so that air cannot bleed away from the primary airflow inside the cyclones. [0053] In more detail, the vortex finder plate 62 of the invention comprises upper and lower vortex finder portions 62 a, 62 b, each of the portions providing vortex finders 60 for respective cyclones in the first and second sets of cyclones 70 , 72 . The first, upper, vortex finder portion 62 a includes five planar segments 102 configured into a ring so as to define a central aperture 104 matching the central aperture 84 of the exhaust manifold 82 . Each of the upper segments 102 defines a central opening 106 (only two of which are labelled for clarity) from which the cylindrical vortex finders 60 depend. As can be seen clearly in FIG. 3 , the vortex finders 60 associated with the second set of cyclones 72 sit within the outlet end of the cyclones and are coaxial to the cyclone axis C 2 . Accordingly, the segments 102 in the first ring are dished downwards slightly out of a horizontal plane. The outer edge of the segments 102 define a downwardly depending wall or skirt 108 , the lower end 108 a of which defines the inner edge of the lower vortex finder portion 62 b. [0054] The lower vortex finder portion 62 b comprises ten segments 110 in total (only three of which are labelled for clarity), corresponding to the number of cyclones in the first set of cyclones 70 . Once again, each segment 110 includes a central opening 112 from which depends a respective one of the vortex finders 60 . With reference to FIG. 3 , it should be noted that the vortex finders 60 of the lower vortex finder portion 62 b sit coaxially within the upper end of each respective cyclone in the first set 70 so as to be centred on the cyclone axis C 1 . Therefore, each segment 110 is angled downwardly with respect to the first ring so that the plane of the segment 110 is perpendicular to the axis C 1 . [0055] It will be appreciated from the above that each of the vortex finders for the stacked sets of cyclones is provided by a common vortex finder plate. Such an arrangement improves the sealing of the cyclone outlets since a single vortex finder plate can be assembled on both upper and lower sets of cyclones which reduces the possibility of air leaks which may occur if the vortex finders for each set of cyclones were provided by an individual vortex finder plate. [0056] In order to secure the vortex finder plate 62 to the second cyclonic separating unit 22 , lugs 111 are provided on the lower vortex finder portion 62 b. Screw fasteners may then pass through the lugs 111 to engage with corresponding bosses 113 (shown in FIG. 5 ) provided on the lower set of cyclones 72 . On assembly, suitable rubber gasket rings 115 a, 115 b are positioned so as to be sandwiched between the upper face of the second cyclone separating unit 22 and the underside of the vortex finder plate 62 . Although various materials may be used for the gasket rings, for example natural fibre-based material, a flexible polymeric material is preferred. It will be noted that since the vortex finder plate 62 fastens directly to the lower set of cyclones 72 , that the gaskets 115 a, b and the second set of cyclones 70 are clamped between them. As a result the gaskets and the vortex finder plate are secured without needing additional fasteners, which reduces the part count of the separating apparatus as a whole as well as reducing weight and manufacturing complexity. [0057] In this embodiment, each vortex finder segment in both the lower and upper portions 62 a, 62 b is demarcated from its neighbouring segment by a line of weakness to allow a degree of relative movement between them. The lines of weakness allow the segments 102 , 110 an element of ‘play’ so that they may find a natural position on top of the cyclones when separator is assembled. However, it should be noted that these lines of weakness are not essential to the invention and the vortex finder member could instead be made rigid with limited or no flexibility between the segments. A suitable material for the vortex finder member is any suitably rigid plastics, for example acrylonitrile butadiene styrene (ABS). [0058] The skilled will appreciated that various modifications may be made to the inventive concept without departing from the scope of the invention, as defined by the claims. [0059] For example, although the vortex finder plate has been described here as being defined by a plurality of interconnected, and integral, segments, optionally demarcated by lines of weakness, the vortex finder plate could also be formed from continuous ring elements with no differentiating features. [0060] With reference to the filter member 86 , it should be noted that in the specific embodiment described above the filter member 86 is provided with a plurality of apertures 100 distributed around its circumference to provide a radial airflow path for air to enter the interior of the filter, the apertures 100 being aligned with a respective one of the radially distributed vortex fingers 80 of the manifold 82 . However, it should be appreciated that the alignment is not essential, and the number of apertures in the filter 86 need not coincide with the number of the vortex fingers 80 . One possibility, for example, is that a single aperture could extend circumferentially about the inlet portion of the filter. It should be noted for example that airflow benefits may be attained by reducing the number of apertures, whilst increasing the aperture area. The important feature is that air is able to flow radially inward into the filter member to access the interior of the filter and then to flow axially inside the tubular structure defined by the filter media before passing through the wall of the filter media. This avoids the need for a chamber to be provided above the filter. [0061] Furthermore, although the filter portion 86 b has been described as cylindrical, it may also be conical or frusto-conical such that the filter portion 86 b tapers towards its lower end 86 c which has a smaller diameter compared to its upper, or inlet, end. A tapered filter portion 86 b may be beneficial in resisting deformation due to the comparatively reduced pressure region in the outlet duct 94 which may tend to impart a ‘curved’ shape to the filer portion 86 b in use.

1a

TECHNICAL FIELD The present invention relates to an antitumor agent for combined use of compounds having a kinase inhibitory effect. Particularly, the present invention relates to an antitumor agent for combined use of a compound having a HGFR inhibitory effect and a compound having a multi-tyrosine kinase inhibitory effect. BACKGROUND ART wherein R 1 is azetidinyl and the like, R 2 to R 5 is a hydrogen atom or a halogen atom, R 6 is C 3-8 cycloalkyl and the like, R 7 is a hydrogen atom and the like, and R 8 is a halogen atom and the like. The compound represented by Formula (I) has potent inhibitory effects against hepatocyte growth factor receptor (HGFR), and thus is useful as an antitumor agent, an angiogenesis inhibitor, and a tumor metastasis inhibitor (Patent Literature 1). HGFR is known to be overexpressed in a large number of tumor cells (Non Patent Literature 1) and involved in malignant alteration of tumors. Further, HGFR is also expressed in vascular endothelial cells, and is considered to cause the proliferation of tumors by promoting angiogenesis (Non Patent Literature 2). On the other hand, the compound represented by Formula (II) has anti-angiogenic actions (Patent Literature 2), inhibitory effects (Patent Literatures 3 to 6) against tyrosine kinases which are reported to be involved in malignant alteration of tumors (Non-Patent Literatures 3 to 5), and the like; and is known as a therapeutic agent for various tumors such as thyroid cancer, lung cancer, melanoma, endometrial cancer, gastric cancer and bladder cancer. In general, antitumor agents are often not effective for all of the patients when they were used individually. Thus, attempts have been made so far to increase the cure rate by combination of plural antitumor agents (Patent Literatures 7 to 9). CITATION LIST Patent Literature Patent Literature 1: WO 2007/023768 Patent Literature 2: WO 2002/032872 Patent Literature 3: WO 2004/080462 Patent Literature 4: WO 2007/061130 Patent Literature 5: WO 2007/136103 Patent Literature 6: WO 2008/026748 Patent Literature 7: WO 2009/140549 Patent Literature 8: US Patent Application Publication No. 2004-259834 Patent Literature 9: U.S. Pat. No. 6,217,866 Non Patent Literature Non Patent Literature 1: Oncology Reports, 5, 1013-1024, 1998. Non Patent Literature 2: Advances in Cancer Research, 67, 257-279, 1995. Non Patent Literature 3: Current Cancer Drug Targets, 6, 65-75, 2006. Non Patent Literature 4: Nature Reviews, Cancer, 10, 116-129, 2010. Non Patent Literature 5: Clinical Cancer Research, 15, 7119-7123, 2009. SUMMARY OF INVENTION Technical Problem However, the therapeutic effects, which have been reported so far, obtained by combination of plural antitumor agents were insufficient, and hence development of a novel combination therapy using antitumor agents has been expected. Solution to Problem In view of such circumstances, the present inventors intensively studied to discover that administration of a combination of the compounds represented by Formula (I) and Formula (II) to a patient suffering from a tumor attains an unexpectedly excellent antitumor effect, thereby completing the present invention. That is, the present invention provides [1] to [8] below. [1] An antitumor agent for combined use of: a compound or pharmaceutically acceptable salt thereof represented by Formula (I): wherein R 1 is azetidinyl, piperidinyl, or a formula —NR 11a R 11b , each of which optionally have a substituent selected from Substituent group A, wherein R 11a and R 11b are the same or different and each is a hydrogen atom, C 1-6 alkyl, or piperidinyl optionally having C 1-6 alkyl, Substituent group A consists of hydroxyl, piperazinyl optionally having methyl, and azetidinyl optionally having dimethylamino, and R 2 to R 5 are the same or different and each is a hydrogen atom or a fluorine atom; and a compound or pharmaceutically acceptable salt thereof represented by Formula (II): wherein R 6 is C 1-6 alkyl or C 3-8 cycloalkyl, R 7 is a hydrogen atom, C 1-6 alkyl, or C 1-6 alkoxy, and R 8 is a hydrogen atom or a halogen atom. [2] An antitumor agent for simultaneous or separate administration of a compound or pharmaceutically acceptable salt thereof represented by the above Formula (I), and a compound or pharmaceutically acceptable salt thereof represented by the above Formula (II). [3] An antitumor agent comprising a compound or pharmaceutically acceptable salt thereof represented by the above Formula (I), and a compound or pharmaceutically acceptable salt thereof represented by the Formula (II). [4] A compound or pharmaceutically acceptable salt thereof represented by the Formula (II) for therapy of a tumor by combined use with a compound or pharmaceutically acceptable salt thereof represented by the above Formula (I). [5] A compound or pharmaceutically acceptable salt thereof represented by the Formula (I) for therapy of a tumor by combined use with a compound or pharmaceutically acceptable salt thereof represented by the above Formula (II). [6] A method of treating a tumor, wherein a compound or pharmaceutically acceptable salt thereof represented by the above Formula (I), and a compound or pharmaceutically acceptable salt thereof represented by the Formula (II) are used in combination. [7] A pharmaceutical composition comprising a compound or pharmaceutically acceptable salt thereof represented by the above Formula (I), a compound or pharmaceutically acceptable salt thereof represented by the Formula (II), and a vehicle. [8] A kit comprising: a pharmaceutical composition comprising a compound or pharmaceutically acceptable salt thereof represented by the above Formula (I) and a vehicle; and a pharmaceutical composition comprising a compound or pharmaceutically acceptable salt thereof represented by the Formula (II), and a vehicle. The compound represented by the above Formula (I) is preferably one or more compounds selected from the group consisting of N-(2-fluoro-4-{[2-({[4-(4-methylpiperazin-1-yl)piperidin-1-yl]carbonyl}amino)pyridin-4-yl]oxy}phenyl)-N′-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide: N-[4-({2-[({4-[3-(dimethylamino)azetidin-1-yl]piperidin-1-yl]carbonyl}amino)pyridin-4-yl}oxy)-2-fluorophenyl]-N′-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide: N-{2,5-difluoro-4-[(2-{[(3-hydroxyazetidin-1-yl)carbonyl]amino}pyridin-4-yl)oxy]phenyl}-N′-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide: N-{2,5-difluoro-4-[(2-{[4-(4-methylpiperazin-1-yl)piperidin-1-yl]carbonyl}amino)pyridin-4-yl]oxy}phenyl)-N′-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide: and N-(2,5-difluoro-4-{[2-({[methyl(1-methylpiperidin-4-yl)amino]carbonyl}amino)pyridin-4-yl]oxy}phenyl)-N′-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide: and more preferably N-(2-fluoro-4-{[2-({[4-(4-methylpiperazin-1-yl)piperidin-1-yl]carbonyl}amino)pyridin-4-yl]oxy}phenyl)-N′-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide: The compound represented by the above Formula (II) is preferably one or more compounds selected from the group consisting of 4-[3-chloro-4-(cyclopropylaminocarbonyl)aminophenoxy]-7-methoxy-6-quinolinecarboxamide: 4-[3-chloro-4-(methylaminocarbonyl)aminophenoxy]-7-methoxy-6-quinolinecarboxamide: 4-[3-chloro-4-(ethylaminocarbonyl)aminophenoxy]-7-methoxy-6-quinolinecarboxamide: N6-methoxy-4-(3-chloro-4-{[(cyclopropylamino)carbonyl)amino]phenoxy}-7-methoxy-6-quinolinecarboxamide: and N6-methoxy-4-(3-chloro-4-{[(ethylamino)carbonyl]amino}phenoxy)-7-methoxy-6-quinolinecarboxamide: and more preferably 4-[3-chloro-4-(cyclopropylaminocarbonyl)aminophenoxy]-7-methoxy-6-quinolinecarboxamide: Advantageous Effects of Invention The present invention provides an antitumor agent for combined use of a compound having a HGFR inhibitory effect and a compound having a multi-tyrosine kinase inhibitory effect. Such an antitumor agent exhibits an excellent antitumor effect compared to cases where these are individually used, and exhibits antitumor effects against various cancer types. BRIEF DESCRIPTION OF DRAWINGS FIG. 1 is a graph showing a combined effect of Compound A and Compound B in a model animal to which human malignant melanoma cell line (SEKI) was transplanted. FIG. 2 is a graph showing a combined effect of Compound A and Compound B in a model animal to which human pancreatic cancer cell line (KP-4) was transplanted. FIG. 3 is a graph showing a combined effect of Compound A and Compound B in a model animal to which human gastric cancer cell line (IM95m) was transplanted. FIG. 4 is a graph showing a combined effect of Compound A and Compound B in a model animal to which human ovarian cancer cell line (A2780) was transplanted. FIG. 5 is a graph showing a combined effect of Compound A and Compound B in a model animal to which human glioblastoma cell line (U87MG) was transplanted. DESCRIPTION OF EMBODIMENTS The compound or pharmaceutically acceptable salt thereof represented by Formula (I) according to the present invention can be produced by the method described in Patent Literature 1. Further, the compound or pharmaceutically acceptable salt thereof represented by Formula (II) according to the present invention can be produced by the method described in Patent Literature 2. Examples of the pharmaceutically acceptable salt include salts with inorganic acids, salts with organic acids, salts with inorganic bases, salts with organic bases, and salts with acidic or basic amino acids. Preferred examples of the salts with inorganic acids include salts with hydrochloric acid, hydrobromic acid, sulfuric acid, nitric acid, phosphoric acid and the like. Preferred examples of the salts with organic acids include salts with acetic acid, succinic acid, fumaric acid, maleic acid, tartaric acid, citric acid, lactic acid, stearic acid, benzoic acid, methanesulfonic acid, ethanesulfonic acid, p-toluenesulfonic acid and the like. Preferred examples of the salts with inorganic bases include alkaline metal salts such as a sodium salt and a potassium salt; alkaline earth metal salts such as a calcium salt and a magnesium salt; an aluminum salt; and an ammonium salt. Preferred examples of the salts with organic bases include salts with diethylamine, diethanolamine, meglumine, N,N-dibenzylethylenediamine and the like. Preferred examples of the salts with acidic amino acids include salts with aspartic acid, glutamic acid and the like. Preferred examples of the salts with basic amino acids include salts with arginine, lysine, ornithine and the like. Especially preferred pharmaceutically acceptable salts are salts with organic acids. The antitumor agent of the present invention may be orally administered in the form of a solid formulation such as a tablet, granule, fine granule, powder or capsule, or in the form of a liquid, jelly, syrup or the like. Further, the antitumor agent of the present invention may be parenterally administered in the form of an injection, suppository, ointment, cataplasm or the like. The dose of the compound or pharmaceutically acceptable salt thereof represented by Formula (I) may be appropriately selected depending on the degrees of symptoms, age, sex and body weight of the patient, difference in sensitivity, route, time and interval of administration, type of pharmaceutical formulation, and/or the like. Usually, in cases where oral administration is carried out for an adult (60 kg body weight), the dose is 10 to 6000 mg, preferably 50 to 4000 mg per day. This may be administered at one time, or dividedly at 2 or 3 times per day. The dose of the compound or pharmaceutically acceptable salt thereof represented by Formula (II) may be appropriately selected as in the case described above. Usually, in cases where oral administration is carried out for an adult (60 kg body weight), the dose is 1 to 600 mg, preferably 4 to 400 mg, more preferably 4 to 200 mg per day. This may be administered at one time, or dividedly at 2 or 3 times per day. In cases where an oral solid formulation is prepared, a vehicle, and, as required, a binder, disintegrator, lubricant, coloring agent, flavoring agent and/or the like may be added to the principal component, that is, a compound or pharmaceutically acceptable salt thereof represented by Formula (I), and a compound or pharmaceutically acceptable salt thereof represented by Formula (II), to prepare, thereafter, a tablet, granule, fine granule, powder, capsule or the like according to a conventional method. Examples of the vehicle include lactose, corn starch, white soft sugar, glucose, sorbitol, crystalline cellulose and silicon dioxide. Examples of the binder include polyvinyl alcohol, ethylcellulose, methylcellulose, gum Arabic, hydroxypropylcellulose and hydroxypropylmethylcellulose. Examples of the lubricant include magnesium stearate, talc and silica. Examples of the coloring agent include titanium oxide, iron sesquioxide, yellow iron sesquioxide, cochineal, carmine and riboflavin. Examples of the flavoring agent include cocoa powder, ascorbic acid, tartaric acid, peppermint oil, borneol and cinnamon powder. These tablets and granules may be coated as required. In cases where an injection is prepared, a pH adjustor, buffering agent, suspending agent, solubilizer, stabilizer, isotonic agent, preservative and/or the like may be added as required to the principal component, to prepare an intravenous, subcutaneous or intramuscular injection, or an intravenous drip infusion. As required, these may be prepared into lyophilized products by conventional methods. Examples of the suspending agent include methylcellulose, polysorbate 80, hydroxyethylcellulose, gum Arabic, powdered tragacanth, sodium carboxymethylcellulose and polyoxyethylene sorbitan monolaurate. Examples of the solubilizer include polyoxyethylene hydrogenated castor oil, polysorbate 80, nicotinamide, polyoxyethylene sorbitan monolaurate, macrogol and glycerin fatty acid ester. Examples of the stabilizer include sodium sulfite and sodium metabisulfite. Examples of the preservative include methyl parahydroxybenzoate, ethyl parahydroxybenzoate, sorbic acid, phenol, cresol and chlorocresol. The antitumor agent of the present invention may be prepared by formulating a compound or pharmaceutically acceptable salt thereof represented by Formula (I), and a compound or pharmaceutically acceptable salt thereof represented by Formula (II) separately, and the both may be administered either at the same time or separately. Further, the two formulations may be placed in a single package, to provide the so called kit formulation. Further, the both compounds may be contained in a single formulation. The type of the tumor to be treated with the antitumor agent of the present invention is not restricted, and examples thereof include fibroma, adipoma, myxoma, chondroma, osteoma, angioma, lymphoma, myeloma, melanoma, myoma, neuroma, glioma, osteosarcoma, myosarcoma, fibrosarcoma, papilloma, adenoma, brain tumor, and cancers such as cervical cancer, esophagus cancer, tongue cancer, lung cancer, breast cancer, pancreatic cancer, gastric cancer, small intestinal cancer in duodenum, jejunum, ileum and the like, large bowel cancer in colon, caecum, rectum and the like, bladder cancer, renal cancer, liver cancer, gallbladder cancer, prostate cancer, uterine cancer, ovarian cancer, thyroid cancer and pharyngeal cancer; and mixed tumors thereof. EXAMPLES The present invention is described in more detail by way of Examples below. [List of Abbreviations] FBS: Fetal bovine serum EDTA: Ethylene diamine tetra acetic acid TV: Tumor volume RTV: Relative tumor volume Compound A: 4-(3-chloro-4-(cyclopropylaminocarbonyl)aminophenoxy)-7-methoxy-6-quinolinecarboxamide mesylate Compound B: N-(2-fluoro-4-{[2-({[4-(4-methylpiperazin-1-yl)piperidin-1-yl]carbonyl}amino)pyridin-4-yl]oxy}phenyl)-N′-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide tartrate Example 1 A Combined Effect of Compound A and Compound B in a Model Animal to which Human Malignant Melanoma Cell Line (SEKI) was Transplanted The human malignant melanoma cell line SEKI (JCRB Cell bank) was cultured using a 10% FBS-containing RPM 1640 medium (SIGMA) in a 5% CO 2 incubator under the condition of 37° C. When the cells reached a state of approximately 80% confluency, the cells were collected using trypsin-EDTA. To these cells, a Hanks' Balanced Salt Solution containing 50% Matrigel was added to prepare a suspension at 5.0×10 7 cells/mL. The cell suspension thus obtained was subcutaneously transplanted at the lateral side of the body of a nude mouse (CAnN.Cg-Foxn1nu/CrlCrlj, Charles River Laboratories Japan, Inc.) in an amount of 0.1 mL, where each group contained six mice. From 11 days after the transplantation, Compound A (10 mg/kg, once daily, for 17 days) and Compound B (100 mg/kg, once daily, for 17 days) were orally administered, either individually or both in a row. Setting the initial day of administration at Day 0, the major axis and the minor axis of a tumor developed in each mouse were measured using Digimatic caliper (Mitsutoyo Corporation) thereafter on Day 3, 7, 10, 14, and 17. The tumor volume and the relative tumor volume were calculated according to the equations below. TV=major axis (mm)×minor axis 2 (mm 2 )/2 RTV=TV on the day of measurement/TV on the initial day of administration The results of RTV were summarized in Table 1 and FIG. 1 . The numbers in the Table indicate an average value±standard deviation (the same will apply to the following Tables). Compared to cases where Compound A and Compound B were each administered individually, the combined use of Compound A and Compound B exhibited a remarkably excellent antitumor effect. Also, as a result of performing two-way ANOVA with respect to log-transformed RTV by setting Compound A and Compound B as the factors, RTV on Day 17 was found to be statistically significant (p<0.05), whereby the synergistic effect of Compound A and Compound B was confirmed. TABLE 1 Day 3 Day 7 Day 10 Control group 1.63 ± 0.10 3.35 ± 0.56 4.95 ± 1.00 Compound A group 1.71 ± 0.19 2.88 ± 0.35 3.74 ± 0.53 Compound B group 1.76 ± 0.22 2.93 ± 0.57 4.06 ± 0.85 Combination group of 1.43 ± 0.06 2.10 ± 0.38 2.66 ± 0.19 Compound A and Compound B Day 14 Day 17 Control group 7.18 ± 1.66 8.65 ± 1.89 Compound A group 5.06 ± 0.49 5.92 ± 0.50 Compound B group 5.23 ± 0.20 5.80 ± 1.35 Combination group of 2.80 ± 0.27 2.77 ± 0.38 Compound A and Compound B Example 2 A Combined Effect of Compound A and Compound B in a Model Animal to which Human Pancreatic Cancer Cell Line (KP-4) was Transplanted The human pancreatic cancer cell line KP-4 (acquired from National Hospital Organization Kyushu Cancer Center) was cultured using a 10% FBS-containing RPMI 1640 medium (SIGMA) in a 5% CO 2 incubator under the condition of 37° C. When the cells reached a state of approximately 80% confluency, the cells were collected using trypsin-EDTA. To these cells, a Hanks' Balanced Salt Solution containing 50% Matrigel was added to prepare a suspension at 5.0×10 7 cells/mL. The cell suspension thus obtained was subcutaneously transplanted at the lateral side of the body of a nude mouse (CAnN.Cg-Foxn1nu/CrlCrlj, Charles River Laboratories Japan, Inc.) in an amount of 0.1 mL, where each group contained six mice. From 11 days after the transplantation, Compound A (10 mg/kg, once daily, for 17 days) and Compound B (100 mg/kg, once daily, for 17 days) were orally administered, either individually or both in a row. Setting the initial day of administration at Day 0, the major axis and the minor axis of a tumor developed in each mouse were measured using Digimatic caliper (Mitsutoyo Corporation) thereafter on Day 3, 7, 10, 14, and 17. The tumor volume and the relative tumor volume were calculated according to the equations below. TV=major axis (mm)×minor axis 2 (mm 2 )/2 RTV=TV on the day of measurement/TV on the initial day of administration The results of RTV were summarized in Table 2 and FIG. 2 . Compared to cases where Compound A and Compound B were each administered individually, the combined use of Compound A and Compound B exhibited a remarkably excellent antitumor effect. Also, as a result of performing two-way ANOVA with respect to log-transformed RTV by setting Compound A and Compound B as the factors, RTV on Day 17 was found to be statistically significant (p<0.05), whereby the synergistic effect of Compound A and Compound B was confirmed. TABLE 2 Day 3 Day 7 Day 10 Control group 2.27 ± 0.25 4.68 ± 0.70 7.12 ± 1.35 Compound A group 1.67 ± 0.16 2.89 ± 0.74 3.77 ± 1.26 Compound B group 1.71 ± 0.26 3.33 ± 1.06 4.72 ± 1.55 Combination group of 1.40 ± 0.14 1.54 ± 0.24 1.64 ± 0.23 Compound A and Compound B Day 14 Day 17 Control group 9.65 ± 2.61 9.92 ± 3.07 Compound A group 4.83 ± 1.75 5.81 ± 2.17 Compound B group 6.53 ± 2.19 9.05 ± 3.71 Combination group of 1.79 ± 0.32 2.13 ± 0.52 Compound A and Compound B Example 3 A Combined Effect of Compound A and Compound B in a Model Animal to Which Human Gastric Cancer Cell Line (IM95m) was Transplanted The human gastric cancer cell line IM95m (Health Science Research Resources Bank) was cultured using a DMEM medium (Wako Pure Chemical Industries, Ltd) containing 4500 mg/mL glucose, 10% FBS, and 10 μg/mL insulin in a 5% CO 2 incubator under the condition of 37° C. When the cells reached a state of approximately 80% confluency, the cells were collected using trypsin-EDTA. To these cells, a Hanks' Balanced Salt Solution containing 50% Matrigel was added to prepare a suspension at 1.0×10 8 cells/mL. The cell suspension thus obtained was subcutaneously transplanted at the lateral side of the body of a nude mouse (CAnN.Cg-Foxn1nu/CrlCrlj, Charles River Laboratories Japan, Inc.) in an amount of 0.1 mL, where each group contained six mice. From 13 days after the transplantation, Compound A (10 mg/kg, once daily, for 21 days) and Compound B (100 mg/kg, once daily, for 21 days) were orally administered continuously, either individually or both in a row. Setting the initial day of administration at Day 0, the major axis and the minor axis of a tumor developed in each mouse were measured using Digimatic caliper (Mitsutoyo Corporation) thereafter on Day 4, 7, 11, 14, 18 and 21. The tumor volume and the relative tumor volume were calculated according to the equations below. TV=major axis (mm)×minor axis 2 (mm 2 )/2 RTV=TV on the day of measurement/TV on the initial day of administration The results of RTV were summarized in Table 3 and FIG. 3 . Compared to cases where Compound A and Compound B were each administered individually, the combined use of Compound A and Compound B exhibited a remarkably excellent antitumor effect. Although no statistical significance was shown by two-way ANOVA, an effect of complete inhibition of tumor proliferation was confirmed by the combined use of Compound A and Compound B. TABLE 3 Day 4 Day 7 Day 11 Control group 1.97 ± 0.16 2.87 ± 0.20 4.91 ± 0.64 Compound A group 1.53 ± 0.12 2.10 ± 0.18 2.65 ± 0.37 Compound B group 1.12 ± 0.08 1.24 ± 0.15 1.75 ± 0.17 Combination group of 0.92 ± 0.12 0.89 ± 0.22 0.76 ± 0.09 Compound A and Compound B Day 14 Day 18 Day 21 Control group 6.27 ± 0.83 8.38 ± 1.41 10.36 ± 1.74  Compound A group 2.65 ± 0.49 2.80 ± 0.47 3.18 ± 0.57 Compound B group 1.85 ± 0.16 3.09 ± 0.48 4.02 ± 1.05 Combination group of 0.73 ± 0.15 0.91 ± 0.14 1.00 ± 0.25 Compound A and Compound B Example 4 A Combined Effect of Compound A and Compound B in a Model Animal to Which Human Ovarian Cancer Cell Line (A2780) was Transplanted The human ovarian cancer cell line A2780 (ATCC) was cultured using a 10% FBS-containing RPMI 1640 medium (SIGMA) in a 5% CO 2 incubator under the condition of 37° C. When the cells reached a state of approximately 80% confluency, the cells were collected using trypsin-EDTA. To these cells, a Hanks' Balanced Salt Solution containing 50% Matrigel was added to prepare a suspension at a concentration of 5.0×10 7 cells/mL. The cell suspension thus obtained was subcutaneously transplanted at the lateral side of the body of a nude mouse (CAnN.Cg-Foxn1nu/CrlCrlj, Charles River Laboratories Japan, Inc.) in an amount of 0.1 mL, where each group contained six mice. Compound A (10 mg/kg, once daily, for 10 days) and Compound B (100 mg/kg, once daily, for 10 days) were orally administered, either individually or both in a row. Setting the initial day of administration at Day 0, the major axis and the minor axis of a tumor developed in each mouse were measured using Digimatic caliper (Mitsutoyo Corporation) thereafter on Day 3, 5, 8, and 10. The tumor volume and the relative tumor volume were calculated according to the equations below. TV=major axis (mm)×minor axis 2 (mm 2 )/2 RTV=TV on the day of measurement/TV on the initial day of administration The results of RTV were summarized in Table 4 and FIG. 4 . Compared to cases where Compound A and Compound B were each administered individually, the combined use of Compound A and Compound B exhibited a remarkably excellent antitumor effect. Also, as a result of performing two-way ANOVA with respect to log-transformed RTV by setting Compound A and Compound B as the factors, RTV on Day 10 was found to be statistically significant (p<0.05), whereby the synergistic effect of Compound A and Compound B was confirmed. TABLE 4 Day 3 Day 5 Control group 2.37 ± 0.60 7.52 ± 1.45 Compound A group 1.92 ± 0.17 4.77 ± 0.85 Compound B group 2.23 ± 0.42 7.01 ± 1.54 Combination group of 1.38 ± 0.12 1.95 ± 0.27 Compound A and Compound B Day 8 Day 10 Control group 17.47 ± 3.75 20.41 ± 6.02 Compound A group  9.51 ± 2.44 12.37 ± 3.53 Compound B group 15.70 ± 2.27 21.29 ± 2.76 Combination group of  2.50 ± 0.76  3.34 ± 1.30 Compound A and Compound B Example 5 A Combined Effect of Compound A and Compound B in a Model Animal to Which Human Glioblastoma Cell Line (U87MG) was Transplanted The human glioblastoma cell line (U87MG) (ATCC) was cultured using a 10% FBS-containing E-MEM medium (SIGMA) in a 5% CO 2 incubator under the condition of 37° C. When the cells reached a state of approximately 80% confluency, the cells were collected using trypsin-EDTA. To these cells, a Hanks' Balanced Salt Solution containing 50% Matrigel was added to prepare a suspension at a concentration of 5.0×10 7 cells/mL. The cell suspension thus obtained was subcutaneously transplanted at the lateral side of the body of a nude mouse (CAnN.Cg-FOXn1nu/CrlCrlj, Charles River Laboratories Japan, Inc.) in an amount of 0.1 mL, where each group contained six mice. Compound A (10 mg/kg, once daily, for 21 days) and Compound B (100 mg/kg, once daily, for 21 days) were orally administered, either individually or both in a row. Setting the initial day of administration at Day 0, the major axis and the minor axis of a tumor developed in each mouse were measured using Digimatic caliper (Mitsutoyo Corporation) thereafter on Day 2, 5, 7, 9, 12, 14, 16, 19, and 21. The tumor volume and the relative tumor volume were calculated according to the equations below. TV=major axis (mm)×minor axis 2 (mm 2 )/2 RTV=TV on the day of measurement/TV on the initial day of administration The results of RTV were summarized in Table 5 and FIG. 5 . Compared to cases where Compound A and Compound B were each administered individually, the combined use of Compound A and Compound B exhibited a remarkably excellent antitumor effect. Also, although no statistical significance was shown by two-way ANOVA performed with respect to log-transformed RTV by setting Compound A and Compound B as the factors, an effect of complete inhibition of tumor proliferation was confirmed by the combined use of Compound A and Compound B. TABLE 5 Day 2 Day 5 Day 7 Control group 1.30 ± 0.19 1.86 ± 0.45 2.45 ± 0.71 Compound A group 0.95 ± 0.08 1.27 ± 0.07 1.59 ± 0.16 Compound B group 0.69 ± 0.05 0.61 ± 0.05 0.56 ± 0.10 Combination group of 0.59 ± 0.05 0.49 ± 0.10 0.44 ± 0.09 Compound A and Compound B Day 9 Day 12 Day 14 Control group 3.19 ± 0.89 5.71 ± 1.58 8.88 ± 2.26 Compound A group 1.85 ± 0.13 3.29 ± 0.32 4.76 ± 0.49 Compound B group 0.57 ± 0.07 0.65 ± 0.08 0.73 ± 0.12 Combination group of 0.36 ± 0.11 0.48 ± 0.16 0.46 ± 0.17 Compound A and Compound B Day 16 Day 19 Day 21 Control group 12.13 ± 3.46  18.47 ± 6.88  23.08 ± 8.72 Compound A group 6.19 ± 0.95 9.60 ± 1.99 11.53 ± 2.57 Compound B group 0.93 ± 0.13 1.65 ± 0.37  2.23 ± 0.51 Combination group of 0.59 ± 0.20 0.78 ± 0.26  0.95 ± 0.38 Compound A and Compound B

1a

CROSS REFERENCE TO RELATED APPLICATION This is a continuation of co-pending application Ser. No. 796,321 filed on Nov. 7, 1985, now abandoned. That application is a continuation of application Ser. No. 407,143, filed on Aug. 11, 1982, now abandoned. BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to apparatuses for endotraceal intubation, and more particularly to a medical instrument which facilitates endotracheal intubation by simultaneously providing visualization of the intubation as well as controlled delivery of gas and suction at the end of an obturator which carries the endotracheal tube. 2 Description of the Prior and Contemporary Art Endotracheal intubation is a medical procedure which concerns the placement of a tube in the trachea of a patient to facilitate breathing or to permit the controlled introduction of certain gasses through the tube by an anesthesiologist, or other medical personnel for appropriate purposes. In the past, endotracheal intubation only has been attempted and accomplished under controlled circumstances which were not acute, i.e., where no immediate medical emergency existed. For instance, uncuffed tracheotomy tubes were used to provide an airway in patients during the Scandinavian polio epidemic of 1952. Unfortunately, the use of these essentially plain tubes was not particularly successful and the mortality rate was approximately eighty percent at the beginning of the use of the tubes. By using a cuffed endotracheal tube and a proper ventilator in conjunction with the tube, the mortality rate was lowered to approximately thirty percent. In the midfifties, a branch of medicine called "critical care medicine" began to develop. Critical care medicine is concerned with treatment of acute patients who have been the victims of serious accidents or the like. To cater to critical care patients, intensive care units have been opened in many hospitals. For instance, the intensive care unit at Baltimore City Hospital opened in 1958 and the intensive care unit opened at Massachusetts General Hospital in 1961. Typically, the patients in these units are critically ill following surgery, accident induced trauma, or acute infectious processes. Trauma is the leading cause of death in the U.S. in patients between the ages of one and forty. Twenty million people will seek emergency room treatment this year, over one hundred and fifty thousand of whom will die from their injuries. A common type of trauma is face trauma wherein the airway function of the patient is compromised. This causes the aspiration of blood or vomitus and results in ventilatory or pulmonary complications. As a result, the most common causes of trauma related deaths are inadequate ventilation, inadequate circulation, or more massive hemorrhage for which there is little recourse. As critical care medicine developed, acute resuscitation techniques were established. Respiratory resuscitation started developing in the 1950's. External cardiac and cardo-pulmonary resuscitation developed in the 1960's. Proper ventilation is critical as pointed out by Doctors Weil and Shubin, former Directors of intensive care at the University of California and the founders of the Society of Critical Care Medicine. The doctors stated that the first priority among the primary functions which determine survival in all critical care units is the maintenance of ventilation and gas exchange. Despite this development in critical care medicine, no heretofore satisfactory method of ventilation has been developed and despite the recognition of the importance of maintaining ventilation and gas exchange, devices known in the prior art have not satisfactorily accomplished this task. In Vietnam, for example, asphyxiation from upper airway obstruction or injury was a common cause of death in the field or enroute to forward surgical facilities. It therefore can be concluded that priorities in critical care medicine must respond to airway management, breathing and circulatory problems and that the efficiency of airway management is essential to optimal circulatory resuscitation. Unfortunately, hardware development in this area has been virtually arrested in terms of development of a single instrument which can provide all the necessary functions. No instrument presently available provides visualization of the airway and airway access in acute resuscitation, the ability to suck debris to avoid aspiration and to assist in obtaining visualization, means for providing ventilation capabilities and also means for carrying and inserting a suitable airway tube in position. Presently, in order to obtain and maintain a properly functioning airway, at least two instruments are required for placement of an endotracheal tube, unless blind insertion of the tube is attempted. The blind insertion of the tube, that is the placement of a tube on a suitable obturator and the insertion of the obturator without visualization, leads to numerous lethal complications. Specifically, the location and passage of the tube cannot be visualized and there is no way to provide ventilation, the much needed reason for placing the tube to begin with, while the tube is being positioned. In some instances, placement of a tube has been enhanced by the use of a laryngoscope which permits entry of the tube and an obtruator which includes an optical stylet for introducing the tube. The use of a laryngoscope along with an obturator and an optical stylet or endoscope requires multi-handed, complicated manipulation of several instruments at once with the critically situated patient being the loser for the inefficiency of such procedures. Specifically surveying the prior art, a larynogoscope with illumination means is shown in U.S. Pat. No. 2,646,036 and an endoscope with illumination means can be found in U.S. Pat. No. 3,269,387. Intubating stylets, i.e., fixtures for carrying thereon tubes to facilitate the insertion thereof, can be found in U.S. Pat. Nos. 2,463,149 and 2,541,402. Bronchoscopy tubes which permit delivery of a fluid or oxygen during use are shown in U.S. Pat. Nos. 4,041,936; 3,941,120; 3,850,162; 3,460,541; 3,348,542; 3,175,557; 2,705,959; 4,090,518; and 4,146,019. U.S. Pat. Nos. 2,912,982 and 3,087,493 teach endotracheal tubes which permit gas suctioning and gas delivery. Surgical endoscopes which provide illumination means in addition to a telescope and which in some instances provide for the delivery of fluids or suction are shown in U.S. Pat. Nos. 3,830,225; 3,572,325; 3,162,190; 2,704,541; and 2,129,391. None of these devices, however, show or suggest the use of an endotracheal tube therewith and each of these apparatuses can only accomplish its function when in position, with tubal ventilation upon removal not being possible. U.S. Pat. No. 3,147,746 teaches an illuminating endoscope which permits intubation, but does not permit simultaneous use of an obturator and visualization. As a result, the obturator is used to place the device in position and only then can visualization take place after the obturator is removed. A similar apparatus wherein an obturator must be removed from a tube so that visualization by a scope can take place is shown in U.S. Pat. No. 3,081,767. U.S. Pat. No. 3,677,262 shows a surgical instrument which permits endotracheal intubation simultaneously with visualization. No means are shown or suggested for accomplishing ventilation during intubation nor are means shown or suggested for selectively retaining and/or ejecting the tube during the intubation process. After reviewing the aforegoing, it is obvious that there has been quite a bit of activity in the field of endotracheal intubation. Nonetheless, no one heretofore has provided an apparatus which integrates all the necessary and desirable features into a single instrument which accomplishes intubation in a safe and optimumly fast way despite all the activity in this area and recent growing emphasis in critical care medicine. Despite this intense emphasis on critical care medicine since the early 1970's, no one has developed an integrated instrument for safely and quickly placing an endotracheal tube. With this as a backdrop, the present invention overcomes the shortcomings of the prior art by providing a medical instrument for facilitating endotracheal intubation or the like which, in a single integrated, apparatus, provides light and visualization for placement of an endotracheal tube, an obturator for support of the endotracheal tube, suction to enhance visualization and to preclude asphyxiation, and a ventilation source so that rapid airway gas exchange can take place. All this has been integrated into a single instrument which can be used with one hand providing for "fast" in and out so that the maximum number of patients can be aided with the lowest possible morbidity. SUMMARY OF THE INVENTION Therefore, a primary object of the present invention is to provide a medical instrument for facilitating endotracheal intubation. A further object of the present invention is to provide a medical instrument for facilitating endotracheal intubation which permits rapid, successful, and nonlethal intubation to be accomplished. A still further object of the present invention is to provide a medical instrument for facilitating endotracheal intubation wherein the intubation is visualized while being effected. Still another object of the present invention is to provide a medical instrument for facilitating endotracheal intubation wherein ventilation can be accomplished as intubation is taking place. Still another further object of the present invention is to provide a medical instrument for facilitating endotracheal intubation wherein suction is provided during intubation to enhance visualization and to preclude lethal aspiration of blood or vomitus. Another further object of the present invention is to provide a medical instrument for facilitating endotracheal intubation which accomplishes all the aforenoted objects and is embodied in a single instrument which can be handled by a physician in one hand. Another still further object of the present invention is to provide an endotracheal intubation instrument which provides means for securing the endotracheal tube until it is in position and also provides means for ejecting the endotracheal tube once it is in position. An additional object of the present invention is to provide a medical instrument for facilitating endotracheal intubation which is compatible with presently known ventilation devices. A still additional object of the present invention is to provide a medical instrument for facilitating endotracheal intubation which is simple in design, inexpensive to manufacture, rugged in construction, easy to use, and efficient in operation. These objects, as well as further objects and advantages of the present invention, will become readily apparent after reading the ensuing description of several nonlimiting illustrative embodiments and reviewing the accompanying drawings. A medical instrument for facilitating endotracheal intubation or the like in a patient, according to the principles of the present invention, includes a handle adapted to be gripped by the user physician; an elongated obturator element fixedly secured adjacent to a first end thereof to the handle, the obturator element for releasably retaining thereon a selected endotracheal tube, the obturator element having a longitudinal lumen disposed therein which extends from the first end of the obturator to the second end thereof, the longitudinal lumen adapted to removably receive therein a portion of an endoscope to permit visualization by the endoscope at the second end of the obturator element; means for selectively retaining and ejecting a selected endotracheal tube when associated with the obturator element; means for providing controlled delivery of gas to the second end of the obturator element; and means for providing controlled suction at the second end of the obturator element. BRIEF DESCRIPTION OF THE DRAWINGS In order that the present invention may be more fully understood, it will now be described, by way of example, with reference to the accompanying drawings in which: FIG. 1 is a pictorial representation of the medical instrument incorporating the principles of the present invention in use in placement of a tube in a patient; FIG. 2 is a pictorial representation of the instrument in use in FIG. 1; FIG. 3 is an enlarged fragmentary partially broken away view of the instrument of FIG. 2; FIG. 4 is a cross sectional view taken substantially through the lines 4--4 of FIG. 3; FIG. 5 is a fragmentary view of an alternate embodiment of the present invention; and FIG. 6 is a pictorial representation of the embodiment of FIG. 5 in use. DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring now to the figures, and more particularly to FIG. 1 thereof, there is illustrated a medical instrument 10 which incorporates the principles of the present invention therein. The instrument 10 is illustrated in use in carrying out an intubation procedure in a patient P, the instrument 10 being held by the hand H of a physician, not illustrated. Disposed on the instrument 10 is an endotracheal tube T having a fixture F for attachment to a cuff inflation apparatus, well known in the art, fixture F being coupled to the tube T by a conduit C. Disposed within the instrument 10 is an endoscope E, as hereinafter further described. Although an endoscope E is illustrated, it is to be understood that other types of medical visualization scopes sometimes called telescopes, bronchoscopes, or the like can also be employed. With reference to FIGS. 2, 3, and 4, the structure of the instrument 10 can be observed. The instrument 10 includes a handle 12 which is fixedly secured to an elongated obturator element 14. The elongated obturator element 14 is sized to accommodate the endotracheal tube T thereon and includes a collar portion 16 for frictionally engaging the end of the endotracheal tube T. The collar portion 16 has an annular recess 18 formed therein for engaging the end of the endotracheal tube T with an annular recess 18 being sized to cause frictional engagement. A trigger 20, which essentially functions as a lever, is pivotably mounted by a pivot mounting 22 to the handle 12. An end 24 of trigger 20 is shaped so that it engages a protrusion PR, commonly annular in shape, disposed on the endotracheal tube T adjacent to the end thereof. When the trigger 20 is drawn by the user toward the handle 12, the end 24 of the trigger 20 pushes the protrusion PR overcoming the frictional engagement between the endotracheal tube T and the collar 16, thereby causing the endotracheal tube to be forced out of engagement with the collar portion 16 and causing the endotracheal tube to be ejected from the elongated obturator element 14. The handle 12 includes a plurality of undulations 26 to enhance the comfort of the handle 12 in the hand H of the physician, as illustrated in FIG. 1, and the trigger 22 is placed in a position relative to the undulations 26 so that it is readily accessible to the physician. The elongated obturator element 14 has a longitudinal lumen 28 disposed therein which is sized to removably receive therein a portion of the endoscope E, as illustrated in FIGS. 3 and 4. Also disposed longitudinally in the elongated obturator element 14 are a longitudinal gas delivery lumen 30 and a longitudinal suction lumen 32 which each terminate and open through the end 34 of the elongated obturator element 14. The longitudinal gas lumen 30 and the longitudinal suction lumen 32 are in communication, respectively, with conduits 36 and 38 disposed in the handle 12 of the instrument 10. The conduits 36 and 38 terminate, respectively, in fittings 40 and 42 which are configured to affix to a conventional gas supply and suction apparatus, an example of which is the Sanders Venturi system. Alternately, one of the other numerous high frequency ventilation systems used in resuscitation and endoscopic procedures can be employed. A pair of vents 44 and 46 are in communication, respectively, with the conduits 36 and 38 and are mounted on the handle 12. The fittings 40 and 42, vents 44 and 46, and the conduits 36 and 38 can be integrally formed with the handle 12 or can be incorporated therein from separate components during manufacture. The vents 44 and 46 are provided to control, respectively, the delivery of gas through the longitudinal gas lumen 30 and the provision of suction to the longitudinal suction lumen 32. When the vents 44 and 46 are uncovered, nothing is delivered or suctioned from the end 34 of the elongated obturator element 14. If the vent 44 is covered by a finger of the physician, gas, usually oxygen, which must be supplied to the patient, is not permitted to exit the vent 44 and is forced through the conduit 36 to the longitudinal gas lumen 30 and out the end thereof. When the finger is removed from the vent 44, the gas does not flow through the longitudinal gas lumen 30 and escapes through the vent 44. By covering the vent 46, suction is created in the conduit 38, by virtue of a suitable suction source being connected to fitting 42, and this causes suction to also be created in the longitudinal suction lumen 32. When the vent 46 is uncovered, the suction in the conduit 38 and the longitudinal suction tube 32 is terminated since atmospheric air can be sucked in through the vent 46. Although vents 44 and 46 are illustrated for modulating the delivery of gas and the provision of suction, it is to be understood that those skilled in the art could substitute alternate means for accomplishing this end. What has been described is a medical instrument which permits simultaneous visualization and illumination, through use in conjunction with an endoscope, as well as suction, ventilation, and a support or obturator for the intubation of an endotracheal tube. This apparatus can be employed with the use of just one hand of a physician, all of these functions being accomplishable simultaneously. Furthermore, the endoscope can be interchanged or replaced as desired without removal of the instrument from its placement within a patient. As illustrated in FIG. 1, when the instrument is held in a semi-vertical or suspension position it can provide anterior lift during intubation. Once the obturator element 14 of the apparatus is in position, the endotracheal tube or the like, which is to be left in the patient after the instrument 10 is withdrawn, is separated therefrom easily and quickly by pulling of the trigger 20 and the pivoting thereof, without the necessity of any more than a single handed operation. An alternate embodiment of the present invention is illustrated in FIGS. 5 and 6. The variation in construction of this embodiment is in the handle portion of the apparatus and therefore that is the only section which is illustrated. In FIGS. 5 and 6, a handle 48 having suitable undulations 50 is shown fixedly secured to an elongated obturator element 52. The elongated obturator element 52 is mounted to the handle 48 intermediate the ends thereof so that the physician's hand, as illustrated in FIG. 6, can grip the handle with the elongated obturator element 52 suspended between the fingers of the hand H of the physician. A pair of vents 54 and 56 are provided and perform the same function as the vents 44 and 46, previously described. Similarly, an aperture 58 is provided, the aperture 58 being the end of a longitudinal lumen which extends through the elongated obturator 52 for accepting therein an endoscope. A differently configured trigger 60 is incorporated in the handle 48 for separating therefrom the end of an endotracheal tube, the trigger 60 being mounted to the handle in the same pivotal relationship as is the trigger 20. This configuration is provided and suggested since it may be of a more comfortable arrangement for some of the required intubation positions. It is also to be understood that other modifications of the structure of the present invention and in particular in regard to the handle portion thereof may be made within the principles and scope of the invention. Additionally, locations of the vents can be such that they are disposed other than in the positions illustrated. The apparatus hereinbefore described can find application in emergency resuscitation as a replacement for the much less sophisticated or dangerous esophageal obturator. In addition, it can be used as a temporary safe ventilation system at disaster scenes or in wartime positions in the field. In ear, nose, and throat medical practices, it may find use as an adjunct in endoscopic procedures and in the intensive care unit it can be employed for airway inspection and changing of endotracheal tubes or the like. In general, the apparatus will find use in the critical care endoscopy and maxillofacial surgery branches of medicine. It will be understood that various changes in the details, materials, arrangements of parts and operational conditions, which have been herein described and illustrated in order to explain the nature of the invention, may be made by those skilled in the art within the principles and scope of the invention.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates to drawer slides and more particularly to a novel universal drawer slide having lateral control of the slide member and improved support for the drawer. This application is a continuation-in-part of my prior U.S. patent application Ser. No. 576,349, entitled "Drawer Slide", filed May 12, 1975, abandoned. 2. Brief Description of the Prior Art In the past, it has been the conventional practice to employ slide members on the underside of a drawer for slideably engaging a channel so that the drawer may be pulled or drawn easily from its storage cavity in a cabinet. Although a variety of slides are known for movably supporting a drawer on a channel, problems have been encountered which stem largely from the fact that the drawer is not supported firmly enough to prevent lateral displacement during movement of the drawer. Also, prior art drawer slides sometimes take the form of a plurality of components which must be carefully installed with respect to alignment and registry between cooperating members. Such a multiplicity of component parts is expensive to manufacture and difficult to assemble or install. Other known drawer slides extend the full length of the drawer and must be specially made to fit each of the many different drawer lengths. Therefore, there has been a long standing need to provide a simple universal slide for a drawer whereby the drawer may be readily moved along a track between limit stops and which preclude wobble or lateral misalignment. SUMMARY OF THE INVENTION Accordingly, the above problems and difficulties are obviated by the present invention which provides a novel slide for a drawer that includes a slide member having a delta shape with downwardly depending parallel guides for slidably engaging the opposing surfaces of a conventional mounting channel. Disposed between the guides and extending into the channel, there is provided a manually releasable positive stop, in the form of a central strip cantilevered from the slide member toward the rear and which is formed with a hooked end. The central strip is normally biased into the channel so as to positively engage a stop provided at one end of the channel so as to block drawer movement in that direction, as the drawer is slid open. The stop may be released and the drawer removed by manually pressing the hook toward the drawer. The opposite side of the hook may be beveled to ride over the stop as the drawer is inserted. A rear flange carried by the slide member readily aligns the slide member with the drawer during installation, and may provide additional engagement between the slide and the drawer. The slide is less than nine inches in length, and preferably less than eight inches long, as compared with the variable normal drawer length of two or three times these lengths. Accordingly, the drawer slide is of universal applicability, which is highly desirable to reduce mould, inventory and other costs in the field. The width of the guide, in its delta embodiment should be at least two and preferably three inches, at the rear of the drawer to provide lateral stability when it is secured to the drawer only at the rear edge thereof. Further, the guides of the slide may be held within 0.010 inch tolerances, with the mounting channel having tolerances in the order of 0.001 or 0.002 inch tolerances. Assuming that the drawer is three times the length of the slide, this means that the lateral movement of the drawer is held to about 1/16 of an inch, and normally to less than this figure. Therefore, it is among the primary object of the present invention to provide a novel slide for a drawer which prevents lateral movement of the drawer during operation. Another object of the present invention is to provide a novel drawer slide which is light weight and of rigidized construction and which is economic to manufacture and easy to install. Still a further object of the present invention is to provide a novel drawer slide for slidably mounting a drawer on a channel member, and which includes means cooperating with a limit stop on the channel for limiting the movement of the drawer along the channel. Still a further object of the present invention is to provide a channel having lateral adjustment means for aligning the drawer with the cabinet opening so that the drawer may ride on the channel without binding against the cabinet in which the drawer is mounted. In accordance with an important feature of the invention a universal drawer slide is provided, with a single slide fitting all normal drawer sizes from less than one foot to two and one-half feet in depth. An additional feature of the inventiion is the controlled smooth and effortless drawer action resulting from the small surface area of the short drawer slide in engagement with the mating channel. BRIEF DESCRIPTION OF THE DRAWINGS The features of the present invention which are believed to be novel are set forth with particularity in the appended claims. The present invention, both as to its organization and manner of operation, together with further objects and advantages thereof, may best be understood by reference to the following description, taken in connection with the accompanying drawings, in which: FIG. 1 is a longitudinal cross sectional view of a drawer having a slide of the present invention installed thereon; FIG. 2 is a cross sectional view similar to the view of FIG. 1 showing the drawer pulled to its open position; FIG. 3 is a plan view of the novel drawer slide as taken in the direction of arrows 3--3 of FIG. 1; FIG. 4 is a transverse cross sectional view of the drawer slide shown in FIG. 3 as taken in the direction of arrows 4--4 thereof; FIG. 5 is a front perspective view of the drawer slide prior to installation on the bottom of a drawer; and FIG. 6 is a transverse cross sectional view of the novel drawer slide illustrated in another installation version. FIGS. 7 and 8 are a bottom plan view and an end view respectively of another embodiment of the invention. DESCRIPTION OF THE PREFERRED EMBODIMENT Referring to FIG. 1, a conventional cabinet is illustrated which includes, in part, a back 10, a bottom 11 and a front 12. The front 12 is provided with an access opening indicated by numeral 13 into which a conventional drawer is slidably mounted. The drawer includes a back 14, a bottom 15 and a front 16. A pair of sides 17 are also included which extend between the front and back 14 and 16, respectively. A handle 18 is mounted on the front 16 so that the drawer may be manually withdrawn from the cabinet or pushed into the cabinet. As the conventional practice, the cavity in the cabinet occupied by the drawer includes a channel 20 on which the underside of the drawer is slidably mounted. The channel includes a U-shaped member having parallel side rails indicated by numerals 21 and 22 throughout the present specification. The channel 20 further includes a mounting bracket 23 which is carried on one end of the channel member and includes an upright flange that is screwed to the back or rear board of the cabinet 10. The channel 20 further includes limit means for restricting movement of the drawer during withdrawal. For example, the extreme edge 24 of the drawer front 16 limits the rearward movement of the drawer when engaged with the cabinet front 12 while an upright projection 25 limits the forward movement of the drawer. The drawer slide of the present invention is mounted on the underside of the bottom 15 of the drawer and is indicated in general by the numeral 26. The novel drawer slide 26 includes a body portion or slide member 27 having a central strip 28 which is normally biased downward between the parallel rails of the channel 20. The central strip 28 includes a hooked end 30 which is intended to engage with the upright projection 25, as shown in FIG. 2, to limit movement of the drawer out of the opening 13. The drawer may be easily removed by manually pressing or bending the strip 20 upwardly so as to clear the projection 25. FIG. 2 also illustrates the fact that the slide member 26 is fixedly carried on the underside of bottom 15 of the drawer so that the slide member travels with the drawer. The slide member is attached to the drawer by means of screws such as 34 and 35 at extreme corner of the delta as in FIG. 3 and a central screw 32 as in FIG. 3. Two screws may be fastened into the rear of the drawer back through holes 45 in flange 44 in place of or in addition to central screw 32. The end of the hook facing to the rear is chamfered or bevelled to ride over the stop 25 as the drawer is put back in place after having been removed from the cabinet. Incidentally, as may be noted in FIGS. 1 and 2, the rails 42 and 43 may be provided with reinforcing ribs 29 at each end of the guide and just before and after the hook 28, 30. These ribs may be triangular or curved from a low elevation at the center to permit passage of the stop 25 to full height adjacent the rails 42, 43 for maximum strength. The ribs 29 are not shown in other figures of the drawings. Referring now in detail to FIG. 3, it can be seen that the slide member 27 is of a delta configuration or shape having its widest portion at the rear of the drawer and its narrowest portion at the front thereof. It can also be seen that the central strip 28 lies on the central longitudinal axis of the slide member and that the strip is in alignment with the channel 20 between its parallel rails 21 and 22. The slide member 27 not only includes a mounting screw 32 which is passed through a hole 33, but includes fastening screws 34 and 35 at opposite sides of the rear of the slide member. The illustrative delta-shaped slide member shown in the drawings is about 5 1/4 inches in width by seven inches long. More generally, it is contemplated that the slide may be from 4 to 9 inches long, with the preferred range being from 5 to 8 inches; and that it may be from 2 to 7 inches wide with the preferred range being from 2 1/2 to 6 inches. The channel mounting screw 36 extends through an elongated slot 37 to permit lateral channel adjustment to align the drawer precisely in the drawer opening of the cabinet structure. For conservation purposes as well as providing light weight construction, the delta shaped slide member 27 may include cutout portions 38 and 39. However, stiffeners may be provided on the opposite edges of the slide member 27 to rigidize or reinforce the construction and are indentified by numerals 40 and 41 in FIG. 4. If desired, the slide member may be of solid construction without ribs 40 or 41 or cutouts; and the material may be of suitable plastic or other material having a high strength to weight ratio. High density POLYETHELENE may be employed, for example, for its toughness and self lubricating qualities. Other known high strength plastic or other materials may also be employed. FIG. 4 further illustrates that the slide member 27 includes downwardly depending guides 42 and 43. The downwardly depending guides 42 and 43 are substantially L-shaped in cross section so as to mate with the configuration of the rails 31 and 22 of the channel 20. The guides 42 and 43 engage with the opposing surfaces of the rails 31 and 22 so that the slide member and drawer are in sliding engagement therewith and no lateral movement is permitted. The underside of the slide guides react with the underside of the inwardly directed channel rail feet to prevent the drawer from tipping down when the drawer is pulled fully open. It can also be seen that the hooked end 30 carried on the end of the cantilevered central strip 28 rides in the center of the channel between the guides 42 and 43. In FIG. 5, the drawer has not been illustrated so that the slide member can be more clearly shown. The slide member 27 is permitted restricted rectilinear movement between the stop member 25 and the stop formed by the engagement of the fronts 16 and 12. The guides 42 and 43 are elongated and readily engage with the opposing surfaces of the rails 21 and 22 of the channel 20 so that adequate support is given for the drawer. To further permit rigidity of construction of the slide member as well as to provide an adequate support, a flange 44 is carried at the rear end of the slide member 27 which can be directly attached to the back 14 of the drawer by screws 45. Such construction further insures proper alignment as a means for squaring-up the slide member in relation to the drawer. The delta slide may be secured to the drawer entirely at the rear edge by fasteners through holes 32, 34 and 35. In addition. fasteners through holes 45 in flange 44 may be used in place of central screw 32 or in addition to screw 32. Referring now in detail to FIG. 6, another version of the present invention is illustrated wherein the channel 20 is modified to include outwardly extending flanges 46 and 47 rather than the inwardly directed flanges associated with the channel showing in FIGS. 1-5. In this embodiment, the slide member 27 includes guides 48 and 49 which include seats that extend around and beneath the flanges 46 and 47 in sliding engagement therewith. Therefore, it can be seen that the sliding member of the present invention provides a novel means for slidably mounting a drawer on a channel member. Limit stops are provided which cooperate with the hooked member or end of the central strip 28 so that rearward and forward movement of the drawer is restricted. Rigidity is achieved by means of the stiffeners 41 and 40 as well as by the flange 44. The device is lightened by material removable to provide apertures 38 and 39 and the device is readily installed by screws 32, 34 and 35, respectively. The central strip 28 is cantilevered from the forward end of the slide member rearwardly and is normally biased by its resilient contruction so that the hooked end substantially rides within the channel 20 between the rails 21 and 22. By this construction, the slide member is easy to install and is economic to manufacture. Another embodiment of the invention is shown in FIGS. 7 and 8. Instead of the delta shape shown in the previous embodiment, a rectangular body or member 50 is used with only a pair of screws 51 and 52 for mounting and stability. A smaller amount of material is used. This version includes a resilient strip 28 with a hooked end 30 and guides 42 and 43 as previously described. In closing, the present invention will be reviewed and considered in connection with known prior art references. By way of background, prior patents include: R. H. Reiss U.S. Pat. No. 3,185,530, granted May 25, 1965, which shows a complex full length drawer slide which must be moulded for the exact drawer length; C. J. Dean U.S. Pat. No. 3,923,347, granted Dec. 2, 1975, which shows a drawer locking mechanism operative at the rear of a drawer assembly; and K. H. Gutner U.S. Pat. No. 3,658,394, granted Apr. 25, 1972, showing two sheet metal members forming an "overcomeable stop" in a slide assembly extending the full length of a drawer. In the following paragraphs, some general features, improvements and advantages of the invention will be recapitulated and reviewed in the light of the above prior patents, and commercial drawer construction techniques. Specifically, the system of the invention provides a drawer guide means that substantially eliminates side play and tipping of the drawer in relation to the cabinet or piece of furniture in which it is installed. It permits quick mounting and fastening of the guide to the drawer, and by virtue of its unique shape and self rigidizing structure, allows for very economical manufacturing. It can be readily and reliably moulded from a self lubricating plastic which provides for a smooth and quiet operating function when sliding in a metal channel attached to a cabinet or furniture structure. An integral resilient stop arrangement is provided which is a positive, manually released device, not merely a warning device. By their very nature, many of the known drawer guide systems do not adequately provide arrangements to eliminate undesirable side play in a drawer unit unless a substantial amount of time is spent in adjusting rollers, or shimming to make a drawer precisely fit the opening. Even then, as the drawer is pulled further from its opening, wobble and side play increase in proportion, or more than proportionately to the withdrawal. Certain constructional features contributing to the improved results will now be reviewed. The plastic drawer guide is triangular or delta in shape, having two rail members spaced apart and a cantilevered strip with a hooked end between these at its rear or base portion. This is a unique feature of the delta guide, since prior art drawer guide units that claim to prevent side play (such as the Reiss reference) show a drawer member that runs the full length of the drawer and fastens onto the back and the front of the drawer structure. The delta guide may be secured to the drawer only at the drawer back. The two screws at each extreme corner provide a very rigid structure and prevent any lateral movement. The two screws through the flange portion prevent the guide from pulling away from the drawer bottom when the drawers center of gravity falls outside the face of the cabinet and the front wants to come down and the back up, such as in a fully extended position, and these screws are then under shear forces. The guide can also be stapled with an air gun stapler along the rear of the delta guide and in the flange near where the screw holes are shown in FIG. 5, for example. The guide of the present invention, because of the flange and short length, can be easily squared with the rear of the drawer back, and a centering jig can be used to center it between the drawer sides prior to fastening. In a mass production shop the one location along the back for fastening results in a great savings of labor since the operator is not shifting the staple gun from one area to another. Also, since the delta guide does not fasten to the drawer front as do full length drawer guides, the machining which would be required in some type of drawer construction, to accept the full length drawer guide is eliminated. Some prior art drawer guide systems, such as that shown in the Reiss patent, have used full length guide members on the drawer with fairly loose tolerances between the cabinet member and drawer member for most of the length of the drawer, and have relied on a device at one end of the drawer guide member to have a frictional contact or close contact with the member secured to the cabinet, to eliminate side play. Therefore, as mentioned earlier, the drawer has a fair amount of wobble when extended and only upon closing does it prevent side play. The delta guide, because of its small size relative to the full length drawer guide, permits the securing of a very accurate part from an injection moulding process. The tolerance between the guide and steel channel that the guide slides in is approximately 0.005 inch. The matching steel guide may be held to about 0.001 inch tolerances. Since the guide is only about 7 inches in length and an average size drawer for a kitchen cabinet is 21 inches, this 0.005 inch will be multiplied about three times to approximately 0.015 inch to 0.018 inch at the drawer front. This provides a drawer with a sufficiently low side play tolerance for the highest quality cabinet and furniture applications and in addition, keeps the drawer tracking straight throughout its length. In view of its small size and weight, the delta guide can be moulded from a thermoplastic material for a fraction of the cost of full length systems. Also, because of its size, it can be moulded to closer tolerances than larger sizes which of necessity must have larger tolerances due to warpage of materials of this type when they are of substantial length (such as the Reiss guide). An additional advantage is that the delta guide will fit all drawer depths due to the smaller size and the fact that it does not fasten at the front and back of the drawer but only at the back. This results in a great savings in manufacturing and also for the cabinent or furniture manufacturer since he does not have to inventory a multiplicity of different drawer lengths. Particularly for the custom manufacturer who builds cabinets of all depths, all that is necessary is to cut the mating steel channel to the cabinet depth required. In the case of the full length drawer guide of Reiss, for example, if this were attempted on the drawer guide member, some function of the guide would have to be cut off in order for it to fit a shorter drawer. The universal applicability of a single guide becomes particularly important when the several thousand dollar cost of a single injection moulding die is considered. Thus, the savings achieved extend from manufacturing, through inventory and simplified manufacturing operations. An additional feature of the delta guide, which is an inherent part of its structure is that, when a drawer is picked up at the front, as when the drawer is fully extended, the front of the guide will stay in the channel and allow the drawer bottom to be lifted away from it. The guide possessing enough resiliency in the plastic to be pulled away from the bottom at the front end of the delta guide a considerable distance and still return to a close fit with the bottom with no damage to the guide or excess stress on the fastening means. The drawer however still maintains lateral stability and the drawer can not be untracked from the steel channel and the "moulded in" positive stop. With regard to the stop arrangements shown in the Reiss and Gutner patents, their "stops" are principally warning devices of either a frictional or resilient nature, or a full length guide system which rely on moulded in areas to achieve the same result. They are both devices which can be overcome by a sustained pull, or lifting the front a small amount, and all are marginal as far as a positive stopping is concerned. As an example, a child who is not mindful of the warning device could pull the drawer out, with danger to himself. Also, for recreational vehicles such as mobile homes and campers, the drawers equipped with this invention could not be shaken out of the cabinet by vibration or acceleration while the vehicle is in motion. The stop device does not require any additional cost to manufacture. After the drawer has been removed reinsertion is easy as the cammed end of the cantilevered plastic strip readily overrides the upstanding metal tab in the steel channel. The drawer may be withdrawn at will by merely pressing on the exposed cantilevered strip so that the right angle abutting surface clears the upstanding metal tab. The drawer can then be slid out of the drawer opening without any pulling or lifting up of the drawer front to clear a projection as is required in some prior art arrangements. An additional feature, contributing to smooth and effortless drawer action, is the small surface area of the guide rails in contact with the slide channel as compared to other full length systems, such as that of Reiss, which use moulded in areas to reduce frictional contact between the cabinet channel and drawer guide. In conclusion, while particular embodiments of the present invention have been shown and described, it will be obvious to those skilled in the art that changes and modifications may be made without departing from this invention in its broader aspects, and therefore, the aim in the appended claims is to cover all such changes and modifications as fall within the true spirit and scope of this invention.

1a

FIELD AND BACKGROUND OF THE INVENTION The present invention relates to a device for reducing the danger of accidental detonation of a land mine and, more particularly, to a shoe for working safely in a minefield and to a method of manufacture thereof. Land mines are usually detonated when a weight, exceeding a predetermined threshold, is applied thereon. The sensitivity to the detonation of a mine is governed, on the one hand, by the desire to provide a mine that will explode under the application of a minimal weight and, on the other hand, a mine that will not be accidentally detonated by small animals passing by, wind-blown debris, etc. Similar to the snowshoe, which enables a wearer to walk on deep snow without sinking, it has been suggested to use a minefield shoe composed of a flat, rigid surface lined with a thick rubber or plastic foam, which, as it is understood, reduces the weight per unit area of the wearer on the ground. The main disadvantages, however, of such a minefield shoe are the difficulty of movement or walking due to the rigidity of the relatively large surface required for contacting the ground, and, of even greater importance, the fact that such shoes are effective only on smooth ground. On uneven ground or on ground having scattered stones, the weight of the wearer is no longer evenly distributed across the entire tread surface but is concentrated on the highest and limited points of contact between the ground and the contact surface of the shoe. Moreover, the rubber or plastic foam is rapidly worn down, requiring frequent replacement. Hence, this type of minefield shoe is not sufficiently safe and is of limited usefulness. U.S. Pat. No. 4,611,411 to Ringler, et al., teaches a minefield shoe that displays improved performance in terms of ground contact. The minefield shoe disclosed contains an inflatable, multiple compartment air cushion. In contradistinction to the snowshoe-type minefield shoe, when the ground contacting surface of the air cushion presses against an uneven terrain or against a protrusion, a portion or portions of the surface move inwardly, the extent of which depends, inter alia, on the air pressure prevailing inside the compartment. Since the outer skin of the compartments is deformable and the interior of the compartments are in fluid communication with each other, the increased internal pressure caused by the decrease in volume will quickly be “absorbed” by all compartments, thus effectively allowing the deformation of the ground contacting surface so as to form a matching counterpart of the terrain. This, in turn, assures that the load on the shoe will, in most cases, still be evenly distributed along the entire ground contacting surface of the air cushion. The compartments making up the cushion fluidly communicate with each other through external tubing having numerous three-way tube junctions (T-type or Y-type fittings). The external placement of the tubes and the accompanying fittings render the minefield shoe vulnerable to failures associated with deflation. Inadvertent and catastrophic deflation can occur when such a tube is accidentally snagged by a foreign object, such that the tube is separated from a fitting, or such that the tube is punctured or torn (e.g., by a sharp object on the ground or by excessive wear. A tube blowout or a seal failure may also occur as a result of an overly-high internal pressure, e.g., from over-inflation. Perhaps the greatest disadvantage of the minefield shoe taught by U.S. Pat. No. 4,611,411 to Ringler, et al., is the susceptibility of the gas cushion to puncturing. Since the compartments of the cushion are designed to be fluidly communicable, in order to provide improved ground contacting and weight distribution, and failure within any one of the compartments (or tubes and fittings) results in substantially immediate and catastrophic deflation of the entire cushion, thereby nullifying the detonation risk-reducing properties of the shoe, and unexpectedly subjecting the user to various kinds of life-threatening dangers. There is therefore a recognized need for, and it would be highly advantageous to have, a minefield shoe that achieves superior ground contact, like that of U.S. Pat. No. 4,611,411, but is highly robust and reliable. It would be of specific advantage for such a minefield shoe to have lower susceptibility to being punctured and to maintain satisfactory function even after being punctured. It would be of further advantage for such a minefield shoe to exhibit improved performance, in terms of weight distribution, even relative to the minefield shoe taught by the above-referenced application. Finally, it would be of further advantage for such a minefield shoe to be simple to manufacture, lightweight, compact, and easy to store and to inflate. SUMMARY OF THE INVENTION According to the teachings of the present invention there is provided a minefield shoe for reducing the danger of accidental detonation of a land mine by a wearer of the shoe, including: (a) a cushion including a plurality of inflatable compartments, the cushion having, when inflated, at least one flexible, substantially flat, ground-contacting surface extending across the compartments; (b) passages, disposed within the cushion, for providing fluid communication between the compartments, and (c) means for attaching the shoe to a boot of the wearer, wherein each of the compartments is in fluid communication with at least one other compartment, via the passages, so as to prevent any significant increase in internal pressure of any one of the compartments resulting from a decrease in internal volume of another compartment, thereby to allow deformation of the ground-contacting surface to form a matching counterpart of terrain engaged by the shoe, while maintaining a substantially even distribution of the load on the shoe along all of the ground-contacting surface. According to further features in preferred embodiments of the invention described below, the passages include a tubular fitting. According to still further features in preferred embodiments of the invention described below, the passages include a fitting having a substantially rectangular external profile. According to still further features in preferred embodiments of the invention described below, the cushion includes at least one additional inflatable compartment that is fluidly isolated from and disposed above the plurality of inflatable compartments. According to still further features in preferred embodiments of the invention described below, the additional compartment is a plurality of top compartments, each of the top compartments being in communication with at least one other top compartment. According to still further features in preferred embodiments of the invention described below, the top compartments have passages, disposed within the cushion, for effecting fluid communication between the compartments. According to still further features in preferred embodiments of the invention described below, the minefield shoe further includes: (d) at least one rigid tread member attachable to an upper surface of the cushion for evenly distributing a load of the wearer along the cushion and across a top surface of the compartments. According to another aspect of the present invention there is provided a minefield shoe for reducing the danger of accidental detonation of a land mine by a wearer of the shoe, including: (a) a cushion including: (i) an inflatable top compartment, and (ii) an inflatable bottom compartment, for providing the cushion, when inflated, with at least one flexible, substantially flat, ground-contacting surface, the top compartment being disposed substantially on top of the bottom compartment, the top compartment being fluidly sealed from the bottom compartment; (b) at least one rigid tread member attachable to an upper surface of the cushion for evenly distributing a load of the wearer along the cushion and across a top surface of the top compartment, and (c) means for attaching the shoe to a boot of the wearer, wherein even with the bottom compartment in a deflated state, the cushion maintains a substantially even distribution of the load on the shoe along all of the ground-contacting surface. According to still further features in preferred embodiments of the invention described below, the inflatable bottom compartment is a plurality of compartments, each of the compartments being in communication with at least one other compartment. According to still further features in preferred embodiments of the invention described below, the compartments have passageways, disposed within the cushion, for effecting fluid communication between the compartments. According to still further features in preferred embodiments of the invention described below, the inflatable top compartment is a second plurality of compartments, each of the compartments being in communication with at least one other compartment in the second plurality of compartments. According to still further features in preferred embodiments of the invention described below, the flexible, substantially flat, ground-contacting surface is bonded to a bottom surface of the bottom compartment to form an integral sheet. According to still further features in preferred embodiments of the invention described below, the flexible, substantially flat, ground-contacting surface is loosely attached to a bottom surface of the bottom compartment. According to still further features in preferred embodiments of the invention described below, the ground-contacting surface is designed and optimized solely for maximal flexibility. According to another aspect of the present invention there is provided a method for producing an inflatable minefield shoe for maintaining an evenly-distributed load on terrain, including the steps of: (a) providing at least two sheets, each sheet including a fabric layer and an impermeable coating adhering thereto; (b) fixing the sheets in a substantially parallel and substantially contacting disposition; (c) bonding the sheets in a series of pre-determined locations, so as to form a plurality of pockets, each of the pockets being in fluid communication with at least one other pocket, wherein the plurality of pockets, upon inflation, enables a ground-contacting surface of the minefield shoe to maintain a substantially even distribution of the load along the ground-contacting surface. According to further features in preferred embodiments of the invention described below, the bonding is effected by means of high-frequency welding and an electrode. According to still further features in preferred embodiments of the invention described below, the bonding is effected by means of heat-sealing. According to still further features in preferred embodiments of the invention described below, the pockets are in fluid communication via passageways disposed within the plurality of pockets. According to still further features in preferred embodiments of the invention described below, the passageways are formed by temporary insertion of a strip between the sheets, at predetermined locations. According to still further features in preferred embodiments of the invention described below, each of the passageways is formed by disposing a tubular element between the sheets. According to still further features in preferred embodiments of the invention described below, the tubular element is bonded to the sheets prior to step (c). BRIEF DESCRIPTION OF THE DRAWINGS The invention is herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of the preferred embodiments of the present invention only, and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the invention may be embodied in practice. In the drawings: FIG. 1 is a side view of the minefield shoe disclosed by U.S. Pat. No. 4,611,411 to Ringler, et al., attached to the boot of the wearer; FIG. 2 shows one of the air cells of the minefield shoe of FIG. 1, along with the tubing structure for interconnecting this cell with the other cells of the air cushion; FIG. 3 is a cross-sectional view of the long side of the air cushion portion of the inventive minefield shoe; FIGS. 4 a and 4 b are cross-sectional views of the short side of the air cushion portion of the inventive minefield shoe, in which fittings for the interconnecting passageways between the inflated compartments are revealed; FIG. 5 is a side view of another aspect of the minefield shoe of the present invention, having two levels of inflated compartments; FIG. 6 is a schematic illustration of a minefield shoe disposed on a mine detonator plate in which the shoe has poor ground-contacting flexibility (FIG. 6 a ) and improved ground-contacting flexibility (FIG. 6 b ); FIG. 7 is a schematic, exploded cross-sectional view of the various layers that make up the top and bottom levels of the gas cushion according to one embodiment of the present invention; FIG. 8 a is a schematic illustration of a top sheet and a bottom sheet of an inventive gas cushion, and a bridge-like device for attaching therebetween; FIG. 8 b is a schematic cross-sectional view of the components of FIG. 8 a , after bonding, in which the bridge-like device forms an internal passageway for fluid communication between adjacent cushions, and FIG. 9 is a graph illustrating the improved weight distribution of the inventive minefield shoe as compared with the minefield shoe disclosed by U.S. Pat. No. 4,611,411, as a function of mine trigger surface area, and for varying length of mine trigger protruding from the soil. DESCRIPTION OF THE PREFERRED EMBODIMENTS The principles and operation of the minefield shoe according to the present invention may be better understood with reference to the drawings and the accompanying description. Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of the components set forth in the following description or illustrated in the drawing. The invention is capable of other embodiments or of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting. Referring now to the drawings, FIG. 1 is a side view of a minefield shoe, attached to the boot of a wearer, disclosed by U.S. Pat. No. 4,611,411 to Ringler, et al., which is incorporated by reference for all purposes as if fully set forth herein. The prior-art minefield shoe includes an inflatable air cushion 2 composed of a plurality of chambers or compartments 4 . When inflated, the compartments form an air cushion having upper and ground contacting surfaces that are substantially flat. The air cushion 2 may be made of an inner, inflatable, rubber, neoprene or the like, balloon 6 and of an outer abrasion and cut resistant fabric 8 . The air cushion may otherwise be composed of an integral single layer of material that is impermeable to gas and having an outer surface which is abrasion and cut resistant. Such a layer should be capable of limiting the extent to which the compartments are inflated and of keeping their volume substantially constant below a certain maximum. The interiors of the compartments communicate with each other by means of tubing 10 extending along the sides of the compartments 4 . One end of tubing 10 may be fixedly closed for example, by folding the tubing edge and clamping the same in its folded configuration as seen at 16 , while the other end of tubing 10 is provided with a valve (not shown), for inflation and deflation of the air cushion. The minefield shoe taught by U.S. Pat. No. 4,611,411 to Ringler, et al., further includes a rigid tread surface 20 for evenly distributing the wearer's weight along the air cushion on top of each of the compartments 4 . While the illustrated tread surface 20 is designed to facilitate compacting the mine-field shoe for carrying and transporting purposes, it is disclosed that the tread surface could also be embodied by a single, rigid plate having an overall surface area substantially the same as that of the upper surface of the air cushion. The tread surface 20 is fitted with straps 26 arranged for easy attachment to a wearer's boot 28 . Although the multiple-compartment air cushion 2 , the tubing 10 interconnecting the compartments, and the tread surface 20 essentially form the mine-field shoe of the instant invention, it has been found advantageous to attach to the upper major flat surface of each compartment, a support plate 30 , thus effecting an even more uniform weight distribution along the entire surface area of the air cushion. The shoe is of the foldable type, including an inflatable gas cushion composed of a plurality of chambers or compartments. When inflated, the compartments form a gas cushion having upper and ground contacting surfaces that are substantially flat. FIG. 2 shows an air cell 86 of U.S. Pat. No. 4,611,411 along with T-connectors 116 in the first four cells, an L-connector 118 in the last cell, and four intermediate rubber tubing sections 120 . A first tubing section 122 is provided with a schematically indicated pinch cock 124 . As mentioned hereinabove, the minefield shoe taught by U.S. Pat. No. 4,611,411 is highly prone to failures associated with deflation, and more specifically, deflation associated with the external placement of the tubes and the large plurality of accompanying fittings, each having two or three joints. Each joint presents a sealing problem that detracts from the reliability of the device. Moreover, deflation can also occur when the tubing is caught by a foreign object, such that the tube is separated from a fitting, punctured by a nail or other sharp object, or torn (e.g., due to excessive wear). Although it is disclosed by U.S. Pat. No. 4,611,411 that the air cushion can be inflated by means of a pump or by means of a pressurized gas bottle, it has been the experience of the present inventors that such means are inappropriate, unless the inflation is performed in a very slow, gradual, controlled manner. When the inflation is performed in a less gradual fashion, the device is highly susceptible to a sealing failure, such as a tubing section 120 becoming detached from a T-connector 116 , because the external tubing has a relatively small diameter, and further in view of the numerous fittings, all of which represent weak points, particularly under high-pressure conditions. By sharp contrast, the minefield shoe of the present invention has compartments that fluidly communicate by means of passages that are internal to the cushion structure. These internal passages are shown in cross-sectional views of the long side (FIG. 3) and short side (FIGS. 4 a - 4 b ) of the air cushion of the inventive device. As in the prior art device, the inventive minefield shoe includes an inflatable air cushion 202 composed of a plurality of chambers or compartments 204 . When inflated, the compartments form an air cushion having upper and ground contacting surfaces that are substantially flat. Unlike the prior-art minefield shoe, however, the interiors of the compartments 204 communicate with each other by a series of internal passages 210 . Internal passages 210 are inherently protected by compartments 204 , and are thus not vulnerable to damage and/or failure due to external sharp objects, rough use under battlefield conditions, and blowouts or leakage due to overinflation, excessive pressures, etc. There is no external tubing for linking compartments 204 , such that the serious problems associated with external tubes and fittings are eliminated. In simplest form, internal passages 210 are one or more sealing gaps disposed in each of internal walls 220 . It has been found to be advantageous, however, to place a fitting in internal passage 210 , as shown in FIGS. 4 a and 4 b . In FIG. 4 a , the fitting is a tubular orifice 222 . FIG. 4 b is a schematic representation of a multiple-orificed fitting 224 . Preferably, multiple-orificed fitting 224 , and tubular orifice 222 have a rectangular profile. An additional inventive aspect of the minefield shoe of the present invention is illustrated in a schematic side view in FIG. 5 . Minefield shoe 300 has a top level 310 of gas-containing compartments 312 and a bottom level 320 of gas-containing compartments 322 . Gas-containing compartments 312 in top level 310 fluidly communicate with each other, preferably by means of internal passages, such as multiple-orificed fitting 224 shown in FIG. 4 b . Similarly, gas-containing compartments 322 in bottom level 320 fluidly communicate with each other. However, top level 310 is fluidly sealed from bottom level 320 . In the event that one or more of gas-containing compartments 322 in bottom level 320 is punctured, top level 310 remains pressurized and intact, thereby maintaining the main safety function of the minefield shoe. Hence, the reliability of minefield shoe 300 is substantially improved relative to the shoe disclosed by U.S. Pat. No. 4,611,411. Preferably, top level 310 and bottom level 320 each have a dedicated valve ( 316 , 326 , respectively) for inflation and deflation. However, it will be appreciated by one skilled in the art that various configurations are possible. In a preferred embodiment, top level 310 and bottom level 320 are fluidly isolated by at least one self-adjusting partition 315 . Self-adjusting partition 315 is typically a flexible, loosely disposed layer that serves both as a bottom wall of top level 310 and as a top wall for bottom level 320 . It has been found to be advantageous to fill top level 310 with at least 60% of the total amount of gas used to inflate minefield shoe 300 , and more preferably, between ⅔ and ¾ of the total amount of gas. Consequently, in the event of a puncture in bottom level 320 , the bulk of the gas remains contained in top level 310 . Moreover, when self-adjusting partition 315 is a flexible, loosely disposed layer, attached approximately near the vertical middle (at a height of H/2) of levels 310 , 320 , self-adjusting partition 315 is distended below the vertical middle, upon inflation, as top level 310 and bottom level 320 reach an identical pressure. In the event that bottom level 320 is punctured, top level 310 continues to provide a thick cushion of pressurized air, such that the weight distribution functionality of the shoe is substantially maintained. Yet another inventive aspect of the minefield shoe of the present invention will be made apparent in comparison to the prior art and in conjunction with the schematic illustration of a minefield shoe contacting a mine detonator plate (FIGS. 6 a - 6 b ). Perhaps the most significant feature of the minefield shoe taught by U.S. Pat. No. 4,611,411 to Ringler, et al., is the improved ground-conforming property relative to the rigid snowshoe-type minefield shoe described hereinabove. FIG. 6 a shows a somewhat flexible bottom surface 350 of a minefield shoe that insufficiently conforms to a mine detonator plate (or mine trigger) 352 protruding from the ground. Although the weight distribution is improved with respect to a rigid bottom surface, the surface area 354 that is unsupported by ground surface 356 is relatively large, such that the force exerted down on the detonator plate surface is high. Consequently, the risk of detonation is correspondingly high. In FIG. 6B, the bottom surface 360 is more flexible, conforming more snugly to detonator plate 352 . The result is improved performance (weight distribution): the surface area 364 that is unsupported by ground surface 356 is decreased, such that less weight is placed on detonator plate 352 . It is thus a cardinal design principle to make the bottom surface of the minefield shoe as flexible as possible. The bottom surfaces of the minefield shoe taught by U.S. Pat. No. 4,611,411 are designed not only for flexibility, but for cut and abrasion resistance as well. Alternatively, the air cushion is composed of a single integral layer of material that is impermeable to gas and having an outer (bottom) surface that is abrasion and cut resistant. In both cases, the additional design constraints result in a bottom surface that is far from optimal in terms of flexibility and weight distribution on uneven terrain. The flexibility compromise is particularly severe because a puncture or tear in the bottom surface completely destroys the efficacy of the minefield shoe. By sharp contrast, and as developed hereinabove, the minefield shoe of the present invention has a two-level design in which the levels are fluidly incommunicable, such that the shoe remains completely functional in the event of a tear or puncture. The ramification, from a design standpoint, is manifest: the requisite double design constraint of flexibility and toughness in the shoe taught by U.S. Pat. No. 4,611,411 is now substantially decoupled. In the minefield shoe of the present invention, the toughness constraint on the bottom surface is greatly relaxed, such that the bottom surface can be designed to have increased flexibility, thereby improving the ground-conforming property and hence, performance. FIG. 7 is a schematic, exploded cross-sectional view of the various layers that make up the top and bottom levels of the gas cushion according to one embodiment of the present invention. A cushion 410 contains a top gas compartment 417 and a bottom gas compartment 420 . Sheet 412 defines the top of compartment 417 , sheet 422 defines the bottom of compartment 420 , and sheet 418 defines the bottom of compartment 417 and the top of compartment 420 . Sheets 418 and 422 are made of any impermeable, and preferably flexible synthetic material such as PVC, polyurethane, or nylon fabric. Sheet 412 is composed of a fabric 414 having an impermeable coating 416 on the underside thereof. Bottom sheet 426 is composed of a porous and flexible fabric that is loosely attached (e.g., sewn) to the bottom surface of sheet 422 . Bottom sheet 426 is sufficiently loose and pliable so as to conform freely to protruding objects that the shoe wearer might step on, such as a mine detonator pin, thereby improving the performance of the inventive minefield shoe. FIG. 8 a is a schematic illustration of a top sheet 448 and a bottom sheet 452 of an inventive gas cushion, and a bridge-like device 454 for attaching therebetween. FIG. 8 b is a schematic cross-sectional view of the components of FIG. 8 a , after bonding, in which bridge-like device 454 forms internal passageways 462 for fluid communication between adjacent cushions. FIG. 9 is a graph illustrating the improved weight distribution of the inventive minefield shoe as compared with the minefield shoe disclosed by U.S. Pat. No. 4,611,411. The X-axis represents the force acting on the mine trigger, for a soldier weighing 100 kg. The Y-axis represents the area of the mine trigger, in cm 2 . Multiple plots are presented, as a function of the length (in cm) of mine trigger protruding from the soil. It is evident that the force acting on the mine trigger increases with increasing area of the mine trigger, and with increasing of the length of mine trigger protruding from the soil, for both the inventive device and the prior-art device. Significantly, with the inventive device, lower forces are exerted on the mine trigger, relative to the shoe disclosed by U.S. Pat. No. 4,611,411, at virtually every measured point on the graph. Without wishing to be bound by theory, this superior performance is attributed, at least in part, to the superior flexibility of the bottom surface of the inventive device. Yet another aspect of the present invention is a manufacturing method for producing a minefield shoe having the basic design taught herein. Whereas U.S. Pat. No. 4,611,411 to Ringler, et al., teaches a device having individual balloons or compartments, fabric housing for the compartments, and a large plurality of tubes and fittings for fluid communication between the compartments, the design of the present invention allows for production using a simple, inexpensive, and highly-efficient bonding process. Two sheets of polyester or nylon fabric, coated with polyurethane, are held together, with the coated sides facing and contacting one another. It will be appreciated by one skilled in the art that other suitable fabrics and coatings may be utilized. The sheets are then bonded at a pre-determined interval along the length of the sheets to form a series of pockets in a single unit-operation. The bonding is preferably effected by high-frequency welding using a single top electrode, or by various, conventional heat-sealing techniques. The passages for fluid communication between the pockets, described hereinabove, may be effected in several ways, including: (1) Prior to the heat sealing operation, a strip of proper dimensions (e.g., 7 mm by 30 mm) is temporarily inserted between the sheets during the heat-sealing process, in order to provide a suitable internal gap or passageway between pockets. Typically the strip is left in place only during the welding operation. (2) Prior to the heat sealing operation, fittings such as tubular orifice 222 or multiple-orificed fitting 224 (see FIGS. 4 a - 4 b ) are inserted between the sheets and are preferably bonded to the sheets at intervals corresponding to a designed, pre-determined length of each pocket. It is presently preferred to use a multiple-orificed fitting 224 having a rectangular profile. The fittings provide the pockets with a mechanically strong passageway that assures full fluid communication between pockets, even under extenuating circumstances (e.g., significant overinflation of the pockets). Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims. All publications, patents and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, no citation or identification of any reference in this application shall be construed as an admission that such reference is available as prior art to the present invention.

1a

CROSS REFERENCE TO RELATED APPLICATIONS This application claims priority based on DE 102005056526.3 filed Nov. 25, 2005, and International Application PCT/EP2006/068878 filed Nov. 24, 2006 which are hereby incorporated by reference in their entirety. TECHNICAL FIELD The invention is concerned with a ski binding. BACKGROUND OF THE INVENTION In the case of a ski binding of this type known from DE 26 60 145 C2, the plate, which is suitable for touring, is locked in its rear region in relation to two retaining clips fastened to the ski by means of two laterally arranged locking elements. In order to release the plate for the touring position, said locking elements have to be displaced or pivoted. An advantage of this arrangement of locking elements is that the latter are positioned within the binding region, i.e. between the front sole holder and the rear heel holder. In comparison to conventional locking elements of touring plates, which locking elements can be fixed to the ski behind the heel holder, there is less distortion of the ski and a better transmission of force during skiing. However, the disadvantage of the known embodiment is that the plate has to be designed to be relatively stiff in order to show sufficient strength for downhill skiing and in order to prevent the plate from tipping in the front region in particular when the ski is tilted. This results in a low resistance to tipping, said resistance to tipping being necessary in particular for downhill skiing. To date, there are either special touring bindings, with specific properties for touring and disadvantageous effects for downhill skiing, or there are downhill skiing bindings which have specific properties for downhill skiing but do not have any touring properties. In recent times, a new skiing technique known under the term “free riding” is being increasingly used. In this case, as a rule, a wider ski than normal is used in order also to be able to travel off piste in deep snow. Great value is nevertheless placed on a stable behavior during skiing downhill, in particular on a large resistance to tipping. In order also to reach locations off piste, a touring property is also desirable, i.e. a possibility, by pivoting up the ski boot, to permit a cross-country running option, which generally presupposes a plate which also pivots. The desirable specific properties of such a ski binding are contrary to each other, therefore there is not yet any satisfactory example of this in the prior art. BRIEF SUMMARY OF THE INVENTION It is therefore the object of the invention to provide a ski binding which, in addition to good touring properties, also provides unrestricted downhill skiing options without the resistance to tipping of the ski binding being impaired. Nevertheless, the ski binding is not to be substantially heavier than a conventional ski binding, i.e. the plate which also pivots is either to be flexible and/or to be able to be composed of a lightweight material. This object is achieved according to the invention by the characterizing features of patent claim 1 . Advantageous embodiments of the invention are described in the subclaims. The invention is therefore based on the general concept that, by means of the further locking element in the front region of the ski binding, in particular in the ball region of the ski boot, the plate is fixed to the ski in the manner of a conventional downhill ski binding and is stiffened, i.e. the plate, in the locked state, is anchored to the front and to the rear ends and also in between repeatedly to parts fixed on the ski. Protection is claimed not only for the features indicated below or illustrated graphically but also for basically any desired combinations of the features stated or illustrated. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S) The invention is explained in more detail below with reference to the drawing, in which FIG. 1 shows a side view of a first embodiment of a ski binding according to the invention, FIG. 2 shows a top view of the exemplary embodiment according to FIG. 1 , FIG. 3 shows a side view of a second exemplary embodiment in a locked position, FIG. 4 shows a side view according to FIG. 3 in an unlocked position, FIG. 5 shows an exploded illustration of a particularly preferred embodiment, FIG. 6 shows a vertical central longitudinal section of said embodiment, FIG. 7 shows a perspective illustration of said embodiment, FIG. 8 shows a side view of said embodiment, FIG. 9 shows a perspective illustration of one variant of said embodiment (with the lever 24 arranged at the front), FIG. 10 shows a side view of said variant, and FIG. 11 shows a vertical central longitudinal section of said variant. DETAILED DESCRIPTION OF THE INVENTION The ski binding 1 illustrated in FIG. 1 has a front sole holder 2 and a heel holder 3 which hold a sole 4 of a conventional downhill ski boot or of a touring ski boot on a plate 5 . The release function, the mechanics and adjustability of said front sole holder 2 and of the heel holder 3 are basically known and are therefore not described in more detail here. The plate 5 can be pivoted upward about a front axis 6 , as known per se. In this case, said axis 6 is arranged transversely with respect to the longitudinal direction of the ski below the front sole holder 2 on a bearing part 7 fixed on the ski. In order to achieve said pivotability of the plate 5 , the rear end of the plate 5 has to be freely movable upward in the arrow direction “T”, i.e. has to be able to be positioned from a locked position into an unlocked position. In the exemplary embodiment illustrated in FIG. 1 , the ski binding 1 according to the invention therefore has front locking elements 8 and rear locking elements 9 which are arranged below the plate 5 . The locking elements comprise a lever mechanism 10 which is arranged on the ski and has two connectors 11 , 11 ′ which are fixed at their one end on a rotary disk 12 and at their other end on locking pins 13 , 13 ′. The front locking element 8 is preferably arranged below the ball region of the boot sole and the rear locking element 9 is preferably arranged below the heel region in order to permit a good transmission of force to the ski. This arrangement has the further advantage that the locking elements are located within the binding region or the region of the boot sole and not outside it, and therefore there is virtually no negative influence on the natural sag of the ski. Recesses 14 , 14 ′, in which the locking pins 13 , 13 ′ engage in order to lock the plate 5 to the ski, are now provided in bearing elements 15 , 15 ′ on the plate 5 . Of course, instead of two recesses and locking pins, as illustrated in FIG. 1 , just one recess and in each case one locking pin can also be provided. The locking pin may also have a different shape than shown in the exemplary embodiment. In order to unlock the plate 5 for touring, the rotary disk 12 merely has to be rotated in the direction of rotation “A” (see FIG. 2 ). In the process, the connectors 11 , 11 ′ which are fixed to the rotary disk 12 are rotated at the same time and therefore the locking pins 13 , 13 ′ are synchronously pushed out of the recesses 14 , 14 ′. The locking elements 8 and 9 are then unlocked, and the plate 5 can be pivoted together with the boot in the arrow direction “T” for touring. In order to lock the plate 5 again for skiing downhill, the operation has to take place in the opposite sequence to the sequence described previously. In order to be able to easily actuate the rotary disk 12 , the latter has a handle (not illustrated specifically) which can protrude laterally from the ski binding. Of course, other operating means are also possible without departing from the scope of the present invention. FIGS. 3 and 4 illustrate a further exemplary embodiment in which the ski binding 1 likewise has front locking elements 8 and rear locking elements 9 . However, in contrast to the exemplary embodiment described previously, here the entire plate 5 is displaced out of the bearings 15 , 15 ′ fixed on the ski or out of the recesses 16 , 16 ′ thereof in the longitudinal direction of the ski (see arrow “B”). In the process, the locking webs 17 , 17 ′ which are fastened below the plate are displaced out of the locked position, which is illustrated in FIG. 3 , for downhill skiing into the unlocked position which is illustrated in FIG. 4 , for touring skiing such that a pivoting of the plate upward is also possible here. In order to be able to displace the locking webs 17 , 17 ′ and therefore also the plate 5 in the arrow direction “B” and vice versa, a lever mechanism (not illustrated specifically) is provided which, as in the case of the exemplary embodiment according to FIG. 1 , may be formed from a crank mechanism but also from any other adjusting mechanism. Furthermore, it is also possible in this exemplary embodiment to also only provide one locking element, for example in the central region of the plate. It is pointed out that the present invention is not restricted to the embodiment described and illustrated but that modifications apparent to a person skilled in the art are also to be included. With reference to FIGS. 5 to 11 , a particularly preferred embodiment is described below, in which use is made very substantially of the construction principles illustrated with reference to FIGS. 3 and 4 . Two flexible base plates 21 and 22 (not illustrated in FIG. 5 ) are fastened consecutively in the longitudinal direction of the ski to the ski 20 by means of screws 19 and are designed in such a manner that they do not provide any significant resistance to flexing movements of the skis 20 . Guide rails 21 ′ and 22 ′ are integrally formed on said base plates 21 and 22 , said guide rails being, for example, in the form of angled profiles with in each case a vertical leg integrally formed on the associated base plate 21 or 22 and a horizontal leg integrally formed on the upper edge of the vertical leg, with it being possible for said horizontal legs to point outward in directions facing away from each other. The bearing part 7 is guided in a longitudinally displaceable manner on the guide rails of the front base plate 21 in the longitudinal direction of the ski. For this purpose, the bearing part 7 has guide elements 23 which are formed in an essentially complementary manner to the guide rails and which engage around and below the abovementioned horizontal legs of the guide rails such that the bearing plate 7 is secured on the front base plate 21 in a virtually play-free manner by means of a form-fitting connection to the guide rails in the transverse and vertical directions. The bearing part 7 can be displaced by means of a hand lever 24 between a front end position in the longitudinal direction of the ski and a rear end position in the longitudinal direction of the ski when the hand lever is folded over from its one position resting on the top side of the ski into the other position resting on the top side of the ski. The hand lever 24 is mounted pivotably about an axis parallel to the transverse axis of the ski on small bearing blocks arranged fixedly on the front base plate 21 or on the top side of the ski, and forms an assembly in the manner of a toggle lever together with a leaf spring 25 , the one end of which is connected fixedly to the bearing part 7 and the other end of which is coupled to the hand lever 24 by means of a transverse axis 26 . The leaf spring 25 is designed with a certain amount of prestressing in such a manner that the leaf-spring end connected to the hand lever 24 in an articulated manner attempts to tension the hand lever 24 in each case into a position in which it is placed onto the upper side of the ski, with the toggle lever assembly formed from the leaf spring 25 and the hand lever 24 being in a dead-center position or position beyond the dead center when the hand lever 24 is placed in the one or other direction onto the top side of the ski. Accordingly, the bearing part 7 , depending in each case on the end position which is taken up by the hand lever 24 and which rests on the top side of the ski, is secured immovably in the front or rear position in the longitudinal direction of the ski. The standing plate 5 is arranged on the bearing part 7 in a manner such that it can pivot about the transverse axis 27 . In this case, the standing plate 5 is secured virtually immovably on the top side of the ski when, with the standing plate 5 placed onto the top side of the ski, the bearing part 7 is displaced out of its rear end position in the longitudinal direction of the ski into the front end position in the longitudinal direction of the ski. During this forward displacement of the standing plate 5 placed onto the upper side of the ski, guide elements 28 which are arranged on the lower side of the standing plate 5 and are formed in a similar manner to the guide elements 23 of the bearing part 7 , interact in a locking manner with the horizontal webs of the guide rails 21 ′ on the front base plate 21 and with identical guide rails 22 ′ on the base plate 22 . If the standing plate 5 is placed onto the top side of the ski in the rear position of the bearing part 7 in the longitudinal direction of the ski, the guide elements 28 arranged in the vicinity of the front end of the standing plate 5 take up a position behind the rear ends, in the longitudinal direction of the ski, of the guide rails 21 ′ of the front base plate 21 while the guide elements 28 , which are arranged further to the rear, of the standing plate 5 each take up a position at corresponding cutouts of the horizontal legs of the guide rails 22 ′ of the rear base plate 22 . If the bearing part 7 is now displaced forward in the longitudinal direction of the ski by the hand lever 24 being folded over from its one position resting on the top side of the ski through approximately 180.degree. into its other position resting on the top side of the ski, then the guide elements 28 are each displaced into a position in which they engage around and under the horizontal webs of the guide rails 21 ′ and 22 ′ of the base plates 21 and 22 such that the standing plate 5 is secured on the base plates 21 and 22 in a manner such that it is free from play in the transverse and vertical directions, but remains displaceable in the longitudinal direction of the ski. This displaceability in the longitudinal direction of the ski is of importance for flexing movements of the ski. Since the standing plate 5 is at a more or less large vertical distance from the neutral bending zone of the ski, during flexing movements of the ski relative displacements inevitably occur in the longitudinal direction of the ski between the standing plate 5 and the base plates 21 and 22 , with, in particular, the relative movements between the rear base plate 22 and the standing plate 5 being relatively large because the region of the rear base plate 22 is at a relatively large distance from the bearing plate 7 which is secured in a virtually immovable manner by the leaf spring 25 and the hand lever 24 resting on the top side of the ski. As soon as the bearing part 7 has been adjusted by means of the hand lever 24 into its rear position in the longitudinal direction of the ski, the standing plate 5 takes up its state, as desirable for touring, in which it can be pivoted upward about the transverse axis 27 relative to the ski 20 , i.e. can be raised from the top side of the ski. After the standing plate 5 is raised from the top side of the ski, a supporting clip 29 can be pivoted from the inoperative position, illustrated in FIG. 6 , into a first or second latchable operative position by pivoting in the clockwise direction through approximately 90.degree. or 180.degree. in the clockwise direction. In the first operative position, the heel-side end of the standing plate 5 is supported at a distance, which is predetermined by the length of the long leg 29 ′ of the supporting clip 29 , from the upper side of the rear base plate. This is advantageous in particular if very steep slopes are to be overcome during the touring. In the second operative position, i.e. when the supporting clip 29 has been pivoted from the inoperative position of FIG. 6 through 180.degree. in the clockwise direction, the heel-side end of the standing plate is supported in relation to the top side of the rear base plate 22 or the top side of the ski at a distance predetermined by the length of the short leg 29 ″ of the supporting clip 29 . This setting is selected if comparatively shallow slopes are to be overcome during touring. Since, during touring, i.e. with the standing plate 5 pivoted up relative to the ski 20 , the bearing part 7 takes up its rear position in the longitudinal direction of the ski, it is readily ensured that the center of gravity of the ski 20 is located in the longitudinal direction of the ski in front of the transverse axis 27 , about which the standing plate 5 pivots on the bearing part 7 , and always attempts to drop the ski tip downward when the skier lifts the foot and therefore the respective ski. The abovementioned center of gravity position of the ski is advantageous in particular for kick turns or similar maneuvers. If appropriate, depressions can be arranged on the top side of the rear base plate 22 , into which the supporting clip 29 can be lowered when placed onto the base plate 22 . As a result, the standing plate 5 which is placed onto the base plate 22 by the supporting clip 29 obtains increased stability in the transverse direction of the ski. The front sole holder arrangement 2 is fastened together with the standing plate 5 to the bearing part 7 by the transverse axis 27 , with a securing of the housing of the front sole holder arrangement 2 in a stationary manner relative to the standing plate 5 being ensured by a form-fitting connection between the housing of the sole holder arrangement 2 and the front end of the standing plate 5 . If a ski boot is inserted into the ski binding 1 , the front sole end of the ski boot is secured by the sole holders 30 of the front sole holder arrangement 2 , with the sole holders 30 engaging around or over the front sole end laterally and from above. Ski boots for downhill skiing have standard thicknesses, and therefore, by means of corresponding adaptation of the shape of the sole holders 30 , vertical play-free securing can readily be ensured. The conditions for touring ski boots are different. In this case, in comparison to boots for downhill skiing, the sole thicknesses may differ greatly. The front sole holder arrangement 2 is therefore combined with a supporting arrangement 31 which can be adjusted in the vertical direction. Said supporting arrangement has a slide 32 which is guided displaceably by means of lateral guide elements 33 on lateral guide webs 34 of the standing plate 5 . The guide webs 34 are arranged obliquely with respect to the plane of the standing plate 5 such that, during longitudinal displacement in the direction of the guide webs 34 relative to the standing plate 5 , the slide 32 is also adjusted in the vertical direction. The position of the slide 32 on the guide webs 34 can be set by means of an adjusting screw 35 , the head of which is mounted axially and radially on the bearing part 7 and the threaded section of which is screwed into a nut 36 which is secured on the slide 32 radially and axially with wobbling mobility. A slide plate 37 which can be displaced in the transverse direction is arranged on the top side of the slide 32 and is tensioned into a central position by means of a helical compression spring 38 . The slide plate 37 is preferably guided on the slide 32 on a curved path, the center of which drops into the heel region of the ski boot. By means of appropriate selection of the materials, it can readily be ensured that the slide plate 37 can be displaced smoothly on the slide 32 . The front end of the ski boot sole is then also supported relative to the front sole holder arrangement 2 with smooth mobility in the transverse direction, as is desirable for a satisfactory release function of the front sole holder arrangement 2 . This smooth displaceability is ensured even if the lower side of the boot sole is to have an anti-slip rubber profile. The heel holder arrangement 3 , which, according to FIG. 5 , is combined with a ski break arrangement, is arranged displaceably in the longitudinal direction on the standing plate 5 . For this purpose, lateral guide webs 39 are arranged on the standing plate 5 and interact in a form-fitting manner with guide elements 40 , i.e. the heel holder arrangement 3 is secured in a play-free manner in the vertical and sideways directions on the guide webs 39 . The securing of the heel holder arrangement 3 in the longitudinal direction of the standing plate 5 takes place by means of an adjusting screw 41 which is mounted rotationally within a housing part of the heel holder arrangement 3 and is tensioned by a thrust spring 42 against a stop 43 fixed on the housing. The adjusting screw 41 has a worm-like external threaded section, the threaded web of which engages in transverse slots of a toothing belt 44 which is arranged nondisplaceably on the top side of the standing plate 5 below the housing of the heel holder arrangement 3 , which housing can be displaced in the guide webs 39 . For this purpose, the toothing belt 44 engages with angled ends in corresponding recesses on the top side of the standing plate 5 . By means of a rotational adjustment of the adjusting screw 41 , the adjusting screw 41 is displaced together with the heel holder arrangement 3 on the toothing belt 44 and therefore in the longitudinal direction of the standing plate 5 . Accordingly, the heel holder arrangement 3 can be positioned in a manner matched to the respective length of the ski boot sole. In this case, the heel holder arrangement 3 remains displaceable relative to the adjusting screw 41 counter to the tensioning force of the thrust spring 42 , which is designed as a helical compression spring, such that the ski boot sole can be clamped in a play-free manner in the longitudinal direction of the sole in such a manner that the thrust spring 42 keeps the heel-side sole holder 45 resiliently in contact with the rear sole end in a basically known manner. As can be gathered in particular from FIGS. 7 and 8 , firstly, and FIGS. 9 and 10 , secondly, the hand lever 24 can be arranged in front of or behind the bearing part 7 in the longitudinal direction of the ski. When it is arranged behind the bearing part 7 , there has to be a corresponding cutout 46 in the standing plate 5 in order to be able to accommodate the hand lever 24 in a pivotably adjustable manner on the top side of the ski or on the top side of the front base plate 21 .

1a

BACKGROUND OF THE INVENTION It has long been desired to defat nuts, thereby lowering their caloric content. However, it has often been difficult to remove significant amounts of fat from nuts without simultaneously diminishing their flavor. The present invention avoids this problem with a process of defatting nuts where the nuts retain a greater portion of their natural flavor. The term "nuts" as used in this description includes whole nuts and pieces of nuts such as peanuts, almonds, Brazil nuts, filberts, pecans, walnuts, and the like. For conciseness, the following disclosure will center around the production of low-fat peanuts. It is not, however, limited to peanuts, because the principles of the present invention, as it relates to peanuts, are also applicable to other nuts. The basic procedures for preparing partially-defatted nuts by pressing oil from them have been known for a number of years. U.S. Pat. Nos. 2,003,415 to Ammann and 3,294,549 to Vix et al. disclose examples of such processes. Broadly, these methods involve pressing nuts until the desired quantity of oil is removed and then steaming or cooking the partially-defatted nuts in water until the nuts are reconstituted to substantially their original size and shape. The nuts have a substantially high moisture content. Further work on the process of Vix et al. is described in a series of articles entitled "Development and Potential of Partially Defatted Peanuts," Peanut Journal and Nut World, January and February 1967, and an article entitled "Low Calorie Peanuts," Food Processing/Marketing, September 1965. Later workers, encouraged by the appeal of low fat products to weight conscious consumers, continued work in this area. U.S. Pat. No. 3,740,236 to Baxley indicates that roasted peanut flavor appears to be reduced in proportion to the percentage of the peanut oil removed during the pressing process. Baxley, however, does not attempt to prevent this flavor loss but, instead, provides a process for improving the flavor of the nuts after defatting. In this process, the defatted nuts are reconstituted in an aqueous binder solution which may contain flavors. U.S. Pat. No. 3,645,752 to Baxley discloses a process of improving the flavor of partially-defatted nuts by quenching them in a flavored oil after roasting. U.S. Pat. No. 4,049,833 to Gannis et al. also recognizes the adverse effect defatting has on the flavor and texture of partially-defatted nuts and suggests reconstituting the partially-defatted nuts with a glycerol-containing solution prior to roasting. When roasted, the reconstituted nuts are disclosed to have an improved flavor, texture, and storage stability. U.S. Pat. No. 4,329,375 to Holloway, Jr. et al. discloses a process for producing low fat nuts which retain more of their natural flavor and aroma. This involves preroasting the nuts, pressing them to partially remove the oil, and then completing roasting. An improvement on this process is disclosed by U.S. Pat. No. 4,466,987 to Wilkins et al. The exact reason for the flavor loss in partially-defatted nuts is not fully understood. The Doctoral Dissertation of M. E. Mason, entitled "Procedures in Studying and Factors Influencing the Quality and Flavor of Roasted Peanuts," (Oklahoma State University, 1963, pp. 63 and 64), indicates that oil pressed from peanuts contains aleurone grains, among other particulates, which appear to contain flavor precursors. The Mason dissertation, however, was not concerned with the preparation of low-fat nuts, but simply with gaining a better knowledge of the source and identification of flavor principles in peanuts. SUMMARY OF THE INVENTION The present invention relates to an improved process for preparing partially-defatted nuts which retain a greater degree of their natural nut flavor. As a result, the partially-defatted nuts produced by this process have an overall combination of texture, flavor, and mouthfeel more closely resembling nut products containing their natural oil content. Nevertheless, this peanut product has a significantly reduced calorie content. The process of the present invention involves pressing raw redskin nuts with a moisture content of 6% to 7% or greater under conditions effective to remove about 40% to 52% of the oil content of the nuts. The pressed nuts are then blanched and roasted to develop their flavor and color fully. DETAILED DESCRIPTION OF THE INVENTION By utilizing the process of the present invention, partially-defatted nuts of all varieties can be produced with a greater degree of their natural flavor and aroma retained. The nuts can be whole or split depending upon the desired end use. Preferably, the nuts used in the process of this invention are decorticated--i.e., the nut shell is removed prior to pressing--to save energy and to enable efficient moisture control. Blanching--i.e., removing the skin--is also advantageously employed in the practice of this invention with the point at which the nuts are blanched being varied, as determined by the skilled artisan. For example, the skins of partially-defatted redskin peanuts to be air-roasted can be removed either before or after roasting to improve the flavor of the nuts. However, nuts to be granular-roasted, as described in more detail below, should be blanched prior to roasting to avoid contamination of the heat transfer vehicle with pieces of skin. Desirably, the nuts are blanched without the traditional heating to loosen their skins. Surprisingly, it has been found that raw redskin nuts at a moisture content above about 6% and preferably about 6% to about 7%, can be effectively defatted without conventional hydration treatment. Although not wishing to be bound by theory, it is believed that traditional defatting methods produced nuts which had a non-uniform moisture content and at least some protein denaturation. In such processes, nuts, such as peanuts, were pre-wetted to a uniform moisture content of less than about 10% and pre-roasted to loosen the skins and facilitate blanching prior to pressing. Further, according to previous teachings, the moisture content of the nuts during pressing was thought to be critical with a narrow range of acceptability (i.e., 3.5% to 4.5%). It was felt that moisture contents below 3.5% would cause excessive breakage and that moisture levels above 4.5% would block oil removal and significantly extend the press time (i.e., by a factor of 2 or more). Further, the present invention's avoidance of a pre-wetting step precludes leaching of soluble materials from the nuts, and oil is readily removed. The peanuts are pressed according to any technique which will extract about 40% to about 50% of the initial oil content of the nut. This can be achieved, for example, by employing a Carver press at applied pressures of greater then about 1,000 psig for about 15 to about 120 minutes. Although the exact oil extraction pressure can be varied to control the degree and rate of extraction, pressures of less than about 1500 psig, are preferred. The pressure is preferably brought up to the desired level as quickly as possible. It should be recognized, however, that although pressures much higher than 1500 psig will achieve more rapid oil extraction, the nuts may be more extensively damaged and the level of retained natural flavor reduced. By contrast, pressures below 1,000 psig may cause less breakage of nuts, but the time required for oil extraction will greatly increase. A desirable balance between calorie content and final product flavor and texture can be achieved by reducing oil content to between about 40% and about 52%. After pressing, the nuts are flattened and undesirably dense, so they must be returned to approximately their original size and shape. It is desired to obtain post-roasting bulk densities of less than about 0.40 grams per cubic centimeter (g/cc), with levels in the range of about 0.32 to about 0.39 g/cc being particularly desirable. Products with these bulk densities have significantly reduced calorie levels but still retain a nut-like crunch and chew. These bulk densities are determined by filling a 500 cubic centimeter graduated cylinder with nuts, determining the weight of the nuts, and dividing the weight in grams by the volume in cubic centimeters. After partial defatting, the nuts must be roasted to obtain a final roasted nut product. Roasting can be accomplished in any suitable manner, such as by the art-recognized technique of dry-roasting, to achieve the desired degree of flavor and color development while at the same time drying the nuts to a moisture content low enough to obtain the desired crunch and chew. When dry-roasting, the pressed nuts must be first wetted by contacting them with sufficient water to reconstitute them not during the contact with water but when subsequently roasted. Such contact is at a temperature of 40° F. to 80° F. with a level of 3 to 7, preferably 4, pounds of water per hundred pounds of nuts. At such ratios, the nuts can be efficiently wetted without significant loss of flavor components which will occur when greater quantities of water are utilized. Nut-water contact can be in any suitable mixing device such as a rotatable coating drum. If the partially defatted nuts are instead oil roasted, no wetting is required. Advantageously in the practice of the present invention, nuts are dry-roasted or granularly roasted--i.e., by contacting the nuts with a finely divided heat transfer vehicle. An Agtron color photometer can be employed to standardize the degree of roast. Typically, this device is employed in the green mode with 12% and 33% plates defining the scale on which a reading of about 60 to about 95 is preferred. Most preferably, the reading will be within the range of about 80 to about 90. In dry roasting, the nuts are roasted in a stream of hot air at a temperature of about 275° F. to about 400° F., preferably about 320° F. to about 335° F., for a time sufficient to achieve the desired roasting of the particular type of nut being processed. For example, the time and extent of roasting will be greater for peanuts (i.e., about 10 minutes to about 30 minutes) than for cashews (i.e., about 3 minutes to about 15 minutes). The most appropriate conditions to be adopted in any particular instance can be readily determined by the skilled artisan. In granular roasting, the nuts are contacted with a finely divided heat transfer vehicle which is heated to a temperature of about 315° F. to about 465° F., preferably about 380° F. to about 410° F. The contact will vary depending upon the particular type of nut being processed, as well as the roasting temperature and the degree of roasting desired. For example, the time and extent of roasting will be greater for peanuts (i.e., about 1 minute to about 9 minutes) than for cashews (i.e., about 0.5 minutes to about 3 minutes). Again, the most appropriate granular roasting conditions can be readily determined by the skilled artisan. The finely divided heat transfer vehicle can be any suitable finely divided material which will absorb heat from a heat source, such as an ignited jet, and transfer heat upon contact with the nuts. The finely divided heat transfer vehicle may be salt, sand, ceramic beads, and metal balls, preferably, ceramic beads. When the desired degree of roast is achieved, the temperature of the nuts should be rapidly reduced so they are not badly over-roasted or burned. This can be accomplished by dumping them rapidly from the roasting apparatus and flushing them with a stream of ambient air. Air blowing can, however, be eliminated if the nuts are dropped a significant distance from the roasting apparatus and are spread uniformly on an open mesh conveyor. After roasting, and preferably after cooling, the nuts can be coated with various flavoring agents, allspice, cinnamon, clove, caraway, bay, sage, ginger, basil, and the like, which can be employed alone or with condiments such as salt, pepper, monosodium glutamate, and the like. Also, texturizers such as glycerine and binders such as natural gums, dextrins, gelatin, sugars, and the like, may be applied. Advantageously, a portion or all of the added materials can be introduced prior to completion of the roasting operation. It is particularly beneficial to infuse with flavored oils in accordance with our copending and simultaneously-filed application entitled "Infusion Flavoring Of Partially-Defatted Nuts", which is incorporated by reference. The following examples arc presented for the purpose of further illustrating and explaining the present invention and are not to be taken as limiting in any regard. Unless otherwise indicated, all parts and percentages are by weight and are based on the total weight of the product at that particular stage in processing. EXAMPLE Ia This example illustrates the production of low-fat roasted peanuts according to the present invention. Raw redskin Jumbo Runner peanuts having 7% moisture may be placed in a Carver press and pressed at 1,200 psig for about 20 minutes. The pressure starts at a value of about 500 psig and is gradually raised to the final pressure of 1,200 psig over the period of pressing. Pressing under these conditions removes about 40% of the original oil content of the nuts. The peanuts are then blanched by means of a whole nut blancher. The blanched peanuts are contacted with water at a level of 4 pounds of water per 100 pounds of nuts. The peanuts are then dry roasted by exposing them to a stream of hot air at a temperature of about 325° F. for about 20 minutes to roast the peanuts to a point where they exhibit a 95 reading on the Agtron color photometer employed in the green mode with the scale defined by the 12% and 33% plates. This product exhibits a bulk density of about 0.40 grams per cubic centimeter, has an acceptable appearance with respect to the number of cracks, and has a good texture and flavor. EXAMPLE Ib Raw redskin Jumbo Runner peanuts having 7% moisture are treated according to the same procedure as described in Example Ia except that the nuts are pressed at 1,200 psig for about 30 minutes. The pressure starts at a value of about 500 psig and is gradually raised to the final pressure of 1,200 psig over the period of pressing. Pressing under these conditions removes about 52% of the original oil content of the nuts. The final roasted product exhibits a bulk density of about 0.38 grams per cubic centimeter, has an acceptable appearance with respect to the number of cracks, and has good texture and flavor. As a comparison, the oil reduction percentage and calorie content for 1/5 cup of nuts produced according to Examples Ia and Ib are compared to full-fat peanuts. The results are shown below in Table I. TABLE I______________________________________ Gms. Oil % Oil Calories % CalorieProduct (1/5 cup) Reduction (1/5 cup) Reduction______________________________________Example Ia 8.26 42.8 110.3 35.6Example Ib 7.28 50.3 99.3 42.0Full Fat 14.46 -- 171.3 --______________________________________ The above description is presented for the purpose of teaching the person of ordinary skill in the art how to make and use the invention. It is not intended to detail all those obvious modifications and variations of the invention which will become apparent to the skilled worker upon reading the description. It is intended, however, that all such obvious modifications and variations be included within the scope of the invention which is defined in the following claims.

1a

CROSS-REFERENCE TO RELATED APPLICATION This application is a continuation of International Application No. PCT/EP2008/060780, filed Aug. 15, 2008, which claims the benefit of European Application No. 07114414.1, filed Aug. 16, 2007, the entire disclosures of which are hereby incorporated by reference. BACKGROUND The invention concerns a disposable diagnostic part comprising a lancing element which is designed for puncturing the skin and has a preferably laterally open collecting channel for taking up body fluid and comprising a detection element which has a test layer provided with reagents and in particular enzymes for the detection of an analyte in the body fluid and is disposed in the collecting channel. The invention additionally concerns a production process for such a disposable part. For blood sugar self-monitoring by diabetics it is desirable to impose the fewest possible number of handling steps on the person concerned and at the same time to ensure a less painful and reliable measurement. Disposable particles are used in this connection for a skin puncture for hygienic reasons. In more recent concepts such as those which are for example described in WO 2007/045412, it is aimed to simplify the sample transfer by integrating the detection element into the disposable part in order to ensure a robust measuring process even with minimal amounts of sample. SUMMARY Starting from this, the object of the invention is to further improve the sample collectors and processes for their production known in the prior art and to design them such that an uncomplicated sample uptake and reliable analyte detection is made possible. The combination of features stated in the independent patent claims is proposed to achieve this object. Advantageous embodiments and further developments of the invention are derived from the dependent claims. The invention is based on the idea of using disposable parts in which the sample can be analysed in a biocompatible and reliable manner in a small volume as near as possible to the lancing member. Accordingly it is proposed according to the invention that the detection element integrated into the collecting channel is provided with a sealing layer which is applied to the test layer and covers the reagents. This allows the integrity of the test layer to be improved even during the assembly and storage period while at the same time ensuring that the test chemistry does not come into direct contact with the skin. Equally it can thus be ensured that no particles of solid become detached from the test layer provided with enzyme-coated dry substances and trigger allergic reactions in the body. This is of particular importance in view of the high number and necessity to repeat the application daily. The sealing also enables the detection element to be shifted distally into the lancing member so that the collecting volume can also be further reduced. In this connection it is important that the duration of the measurement is not unacceptably elongated for the user. A preferred embodiment provides that the sealing layer is dissolvable when the collecting channel is filled by body fluid so that the analyte comes into contact with the reagents. In this case it is advantageous when the time required to dissolve the sealing layer in the body fluid is less than 10 s, preferably less than 2 s. In order to facilitate a rapid dissolving it is advantageous when the sealing layer is designed as a liquid film or flowable fluid film. In order to further improve protection against detachment of particles it is of particular advantage when the sealing layer encloses a margin of the detection element which borders the test layer. In a constructionally advantageous embodiment the detection element has a support for the layers of material which are applied without having a shape of their own, where said support can be preferably made from a flat material. In this connection the test layer is located on the support and a sealing layer is provided on its side facing away from the support. It is also advantageous when the lancing element consists of metal, in particular of steel. In order to have as little influence as possible on the test properties and in order to optimize the layer adaptation it is advantageous when the test layer is provided with a substance that is also present in the sealing layer. It is advantageous for the application of body fluid obtained by the lancing when the detection element is firmly inserted into an end section of the collecting channel and the test layer is aligned in the lancing direction of the lancing element. A special aspect of the invention is that the sealing layer is formed from non-ionic surfactants. In this connection it is also conceivable that only a part of the lancing element is provided with a coating formed from non-ionic surfactants especially to improve the hydrophilicity and to create a surface which is optimized for blood uptake. In this connection it is possible that the abrasion-resistant sealing layer covers a part of the lancing element which penetrates into the skin. Polysorbates and preferably polysorbate 20 and/or polysorbate 80 are particularly preferably used. It is also conceivable that the non-ionic surfactants contain poloxamer, preferably poloxamer 188. Another advantageous embodiment provides that the non-ionic surfactants contain at least one substance selected from the group comprising fatty alcohol polyglycol ethers, glucamides, fatty alcohol ethoxylates, alkyl-polyglycosides, sucrose fatty acid esters. The invention also concerns a magazine containing a plurality of disposable diagnostic parts according to the invention for use in a hand-held device especially for blood sugar determination as well as a system for analysing a body fluid, in particular as a hand-held device for blood sugar determination having at least one disposable diagnostic part according to the invention that is disposed therein or can be used therein. With regard to the process the object mentioned above is achieved in that the lancing element and/or the detection element is at least partially coated with non-ionic surfactants as a coating material. This can be advantageously achieved in that the coating material is applied to the surface to be coated in an at least predominantly anhydrous solvent, preferably ethanol. The solvent can then be removed after the coating by a stream of gas, a vacuum and/or by heating. The coating material is advantageously applied to the surface to be coated by means of dip coating, spray coating or contact coating. In this case it may be advantageous when the viscosity of the coating material is adjusted by additional components. A further improvement provides that the detection element is cut out of a flat material and that the coating material is applied to the cut-out detection element before or after it is inserted into the lancing element. For the production technology it is also advantageous when the detection element is placed on a support after the coating and in particular its front end is placed on a light guide and that subsequently the assembly unit consisting of support and detection element is assembled with the lancing element. In order to adjust the viscosity of the coating material it is conceivable that a liquid surfactant is combined with another non-ionic (optionally also solid) surfactant provided that the resulting mixture is above all non-crystalline or flowable. BRIEF DESCRIPTION OF THE DRAWINGS The invention is further elucidated in the following on the basis of an embodiment example shown schematically in the drawing. FIG. 1 shows a blood sugar measuring instrument with a microsampler inserted therein as a disposable diagnostic part in a diagrammatic representation. FIG. 2 shows the microsampler in a top-view of a truncated perspective representation. FIG. 3 shows the microsampler in a truncated side-view. FIG. 4 shows an enlarged section of FIG. 2 . DETAILED DESCRIPTION The disposable diagnostic parts 10 shown in the drawing can be used as microfluidic sample collectors or microsamplers for a blood sugar determination in a hand-held device 12 designed therefor, where it is possible to carry out a glucose detection with a minimal amount of sample in the disposable part. For this purpose the microsamplers 10 comprise a lancing element 14 with a slot-shaped collecting channel 16 which is open on both sides and a detection element 18 disposed therein for an optical or electrochemical measurement directly in the collecting channel 16 , where the detection element 18 and optionally also the lancing element 14 is provided with a special coating 20 made of non-ionic surfactants. A holder 22 for the lancing element and the detection element allows coupling to a lancing drive 24 for a puncture into the skin 26 for example of a finger of a user. As shown in FIG. 1 the microsamplers 10 can be brought successively into an active application position in a magazine 28 which can be inserted into the instrument 12 . In this connection the tip 30 of the active lancing element 14 points in a distal direction towards the body part 26 while a coupling end 32 of the holder 22 is coupled with the lancing drive 24 for a drive coupling and signal coupling. The body fluid (blood or tissue fluid) taken up during the skin puncture in the collecting channel 16 can be analysed directly photometrically or electrochemically by means of the detection element 18 where the signals are evaluated in an evaluation unit 34 in the instrument. In this connection it is also possible to indicate the result of the measurement to the user on a display 36 thus enabling an on-site blood sugar monitoring without complicated handling steps. As shown in FIG. 2 the shaft-shaped elongate lancing element 14 has a transverse continuous longitudinal slot as a collecting channel 16 . This slot enables, optionally by means of capillary action, the transfer of a microscopic amount of liquid onto the detection element 18 which is aligned in the direction of the tip 30 . The elongate slit opening that is open on both sides ensures an effective uptake of liquid without the risk of blockage by cell components. In order to withdraw blood in the gentlest possible manner with as little pain as possible it is provided that the volume of the collecting channel 16 is only a few tens of nanoliters. In the side view of FIG. 3 it can be seen that the proximal end of the lancing element 14 is plugged onto the holder 22 provided with lateral grooves in a clamp-like manner so that the detection element 18 which is applied to the end of the holder 22 engages in the collecting channel 16 . The distal section of the lancing element 14 made of steel is ground such that it slopes towards the tip 30 in order to facilitate the skin puncture by a reduced cross-section. FIG. 4 shows the detection element 18 composed of several layers in an enlarged section. A transparent support 38 is provided as a base which rests on an arrangement of light guides 40 which cross the holder 22 . A test layer 42 is located on the support 38 and is provided with reagents for a glucose detection in the blood fluid collected in the collecting channel 16 and optionally further auxiliary substances. The reagents can consist of a known enzymatic system which reacts irreversibly with glucose with a colour change but do not dissolve in the blood fluid. An optical detection by the instrument is enabled by means of scattering particles within the chemistry system with back-scattering of the measuring light that is radiated in via the arrangement of light guides 40 . The sealing layer 20 covers the test layer 42 and thus seals the reagents so that firstly a good storage stability is achieved and reagent particles are prevented from detaching from the dry-stored test surface. The sealing also results in an important user advantage in that it prevents direct skin contact with the test surface or with substances that are detached therefrom during the puncture. The sealing layer 20 also advantageously encloses the margins of the test area 42 in order to reliably prevent a detachment of particles. This is particularly important when the detection element 18 is made by cutting it from a large area of coated foil material. In order to not significantly impair the detection of the analyte, the sealing layer 20 is dissolvable when blood fluid which flows into the collection channel 16 is applied thereto. The time required for an adequate dissolution i.e. the time until a measurement signal that can be analysed is obtained should be less than 2 seconds in order not to limit the user convenience. Accordingly the sealing layer 20 should have a high hydrophilicity where a liquid film design is advantageous. It goes without saying that the sealing layer 20 should be biocompatible so that it does not itself trigger disadvantageous reactions upon skin contact. This can be achieved in a particularly reliable manner by using pharmacologically approved harmless substances as well as harmless substances that are approved for food chemistry as a coating material. However, such substances should not have independent pharmacological functional properties within the scope of the pharmacological registration. Finally the coating material should not have an effect on the test reagents and the test process and thus on the result, regardless of whether a contact with the test surface takes place during production, storage or not until sample measurement. Ideally an existing test chemistry should not only be compatible with regard to the coating material but should also advantageously itself contain this material as the test area 42 . Thus, the test area 42 can contain that substance which is also used as a sealing material, as a wetting agent which is in any case required. In this manner critical concentration gradients or disadvantageous changes in the overall system are avoided. A coating 20 ′ of the lancing element 14 can also prove to be advantageous in order to create a hydrophilic surface for the uptake of body fluid especially in the area of the collecting channel 16 . It is also possible to reduce the friction during lancing and thus the lancing pain by means of a coating in the area of the tip 30 . In this connection non-ionic surfactants and above all polysorbates have proven to be a particularly suitable coating material for fulfilling the aforementioned requirements and enabling a mass production of disposable articles in a practical manner. Polysorbate 20 (PS 20) which has the following advantages is particularly preferably used: PS 20 is used in pharmaceutical preparations (injection solutions) and is also found in foods. PS 20 can be stored for a long period and is still active even long after the expiry date. PS 20 has a high molecular weight and thus hardly diffuses through body tissue. PS 20 is viscous at room temperature and dissolves well in the solvent ethanol (and not only in water). PS 20 is sterile in the solvent ethanol, does not become contaminated with microorganisms and wetted areas are sterilized by the solvent. PS 20 can be easily applied in an ethanolic solution and rapidly and readily penetrates into capillary structures due to the low solvent viscosity. PS 20 applied from ethanol can be rapidly and reliably freed from ethanol (e.g. by a stream of air or a vacuum). PS 20 does not form a crystal lattice and consequently rapidly dissolves on contact with the water of the sample (blood) because a high enthalpy of solution is not required to overcome lattice forces. A rapid interaction with the sample also leads to a rapid wetting. PS 20 also creeps (depending on the amount) into the finest structures after drying. The hydrophilicity and wetting rate appears to become even better and not poorer after some storage time. PS 20 did not exhibit a detectable effect on the detection reaction in the initial experiments. PS 20 should inhibit coagulation to a slight extent but not in a functional manner (and indeed only in the collecting channel, whereas outside the channel the dilution is too high). The consistency or viscosity of PS 20 can, if necessary, be optimized by adding other components. For example an addition of poloxamer 188 (solid) can suitably modify the creep capability of PS 20. Polysorbate 80 has also proven to be a suitable coating material. The following detergents are further conceivable classes of substances which, although being foreign to the body, are nevertheless used in food chemistry and biochemistry or molecular biology: AEOs: fatty alcohol polyglycol ethers CH3—(CH2)16—CH2—(OCH2CH2)n—OH n=1-20 glucamides, derived from fatty acids and glucose R—CO—NH—CH2—(CH2)4—CH2—OH R═C11H23 fatty alcohol ethoxylates APGs (alkyl-polyglycosides) polyglycosil-O—(CH2)n—CH3 n=e.g. 12 sucrose fatty esters (sucrose: glucose-C6)-O—CO—(CH2)n—CH3 n=10-16 Of course combinations of these substances with one another or with other substances are conceivable. Hence, when producing disposable diagnostic articles 10 it is advantageous that the lancing element 14 and/or the detection element 18 is at least partially coated with non-ionic surfactants as a coating material. This can be achieved by applying the coating material to the surface to be coated by dip coating, spray coating or contact coating. The coating material is advantageously applied to the surface to be coated in ethanol as a solvent and subsequently the solvent is removed for example by a stream of gas, a vacuum and/or heating. The detection element 18 as a cut-out piece of flat material can be attached after coating to the support 22 i.e. with its front end on the light guide 40 and subsequently the assembly unit consisting of support 22 and detection element 18 are assembled with the lancing element 14 . Further details on this are given by the patent application PCT/US07/65918 to which reference is expressly made in this connection.

1a

FIELD [0001] The present disclosure relates in general to foodservice containers, and more particularly to transporting and placing foodservice containers. BACKGROUND [0002] In the foodservice industry, foodservice containers enable foodservice staff to transport foodstuffs, dishes, and other items to and from food serving areas. [0003] One example of a foodservice container is a bus tub, which can be used to load and carry dirty dishes from a restaurant's dining room to the kitchen area. Another example of a foodservice container is a serving tray, which can include, but is not limited to, a steam table pan. Serving trays are typically used to transport foodstuffs from a food preparation area to a food serving area, such as a dining table, steam table, or the like. [0004] However, conventional foodservice containers are not necessarily designed for optimum operational efficiency. For example, a food serving tray that bears fresh foodstuffs or has been in a steam table for a significant period of time may be hot or have substantial condensation on some or all of its surface. The outside of a bus tub may be contaminated with water, grease, or food particles during use. In addition, some foodservice containers may leak liquids. Use of foodservice containers in these or other conditions may increase a risk of an undesirable water, grease, or some other contaminant being left in a food serving area, such as on a table, chair, or the like, which may damage consumer assets, such as a diner's clothing. Thus, conventional foodservice containers are less than perfect. SUMMARY [0005] Various embodiments of the present disclosure allow a device configured to facilitate handling of a foodservice container in a way that prevents a lower portion of the foodservice container from coming into contact with a dining-room surface. [0006] In one aspect of the disclosure, a device includes a sleeve and two or more handles. The sleeve has an open top and includes a bottom, which covers at least a part of the lower portion of the bus tub, and one or more side portions, which extend less than the full height of the bus tub. The sleeve prevents the lower part of a bus tub placed in the sleeve from coming into contact with a dining-room surface. The handles facilitate carrying the bus tub, and can be coupled to a part of the sleeve so that, when the bus tub is inserted into the sleeve, the handles are on generally opposite sides of the bus tub. The bottom and the side portions can be coupled together, with an attachment cover protecting the point of attachment. The sleeve can be sized to facilitate removal of the lower part of the bus tub before placing the bus tub on a kitchen surface. The handles can be coupled to each other to form a handle assembly which can be made from a single length of material. Some or all the sleeve can be made of multiple layers, and part or all of the handle assembly can be located between an inner and outer layer. Layers can be made of different materials, with one or more layers being made to resist liquid absorption. [0007] The device can include an insulated sleeve to prevent the lower part of a steam table pan placed in the insulated sleeve from coming into contact with a dining-room surface. The insulated sleeve can be sized to facilitate removal of the lower part of the steam table pan prior to placing the steam table pan on a kitchen surface. BRIEF DESCRIPTION OF THE DRAWINGS [0008] Aspects of this disclosure will become apparent upon reading the following detailed description and upon reference to the accompanying drawings, in which like references may indicate similar elements: [0009] FIG. 1 is a perspective view of a foodservice container caddy according to various embodiments of the present disclosure; [0010] FIG. 2 is an end view of a foodservice container caddy according to various embodiments of the present disclosure; and [0011] FIG. 3 is an end view of a foodservice container caddy according to various embodiments of the present disclosure. DETAILED DESCRIPTION [0012] The following is a detailed description of embodiments of the disclosure depicted in the accompanying drawings. The embodiments are described in such detail as to clearly communicate to one of ordinary skill how to make and use the claimed invention. However, the amount of detail offered is not intended to limit the anticipated variations of embodiments; on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure as defined by the appended claims. [0013] A foodservice container caddy (hereinafter referred to as a “Caddy”) according to various embodiments can be used to transport and place foodservice containers without portions of the foodservice containers coming into contact with a surface. In addition, such a device can enable foodservice staff to handle foodservice containers without risk of personal exposure to hazardous surfaces. Note that although Caddies designed for bus tubs and steam table pans are used as the primary examples throughout, some embodiments of a Caddy can be used for handling various different foodservice containers. [0014] As used herein, the terms “container” or “foodservice container” are used interchangeably unless otherwise specified. Foodservice containers include, but are not limited to, tubs, trays, pans, or the like used in the foodservice industry or foodservice establishments such as restaurants, dining halls, cafeterias and cafés. Bus tubs, steam table pans, and food serving trays are examples of foodservice containers. In some embodiments, the container can have a shape that includes an upper portion and a lower portion. For example, a container might have a bottom, one or more sides, and a lip structure, where the bottom and a lower portion of the sides make up the lower portion of the container, and the lip structure and an upper portion of the sides make up the upper portion of the container. In some embodiments, the lip structure of the container can be a circumferential “lip” that extends along the top of all sides of the container, handle structures integrated into the structure of the container, or the like. [0015] In some embodiments, a Caddy allows foodservice staff to handle and utilize a container without portions of the container coming into contact with a surface. For example, a bus tub, which can be utilized by foodservice staff to clean a dining-room table and collect used diningware after consumers have departed, may accumulate water, grease, or some other liquids on its outer surfaces after the bus tub has been deposited on a kitchen surface to unload the used diningware to be cleaned. Placing the bus tub into a Caddy can help ensure that, when the bus tub is carried to and placed on a surface or dining-room surface, any liquids on the outer surface of the container do not touch or otherwise contaminate the dining-room surface, thereby preventing such liquids from damaging the dining-room surface or damaging clothing or other personal assets of customers. As used herein, the term “dining-room surface” includes, but is not limited to, a dining-room table, dining-room floor, dining-room upholstery, or the like. [0016] In another example, a steam table pan, which can be utilized by foodservice staff to deliver cooked food to a steam table in a dining room, may, in addition to accumulating water on its outer surface from steam condensation, have surfaces that are too hot to be safely handled by foodservice staff without some form of thermal protection device, such as a thermal glove. Some embodiments of the Caddy can incorporate materials that have insulating properties to ensure that, when the steam table pan is carried to or from a steam table, any liquids that have accumulated on the outer surfaces of the steam table pan do not drip onto dining room surfaces, and that foodservice staff, dining-room surfaces, and the like are not damaged, injured, or otherwise harmed by the temperature of the steam table pan. [0017] In some embodiments, the Caddy can include a sleeve (also referred to herein as a “receptacle”, “sheath”, and the like) and handles. In some embodiments, the sleeve can be made of multiple layers of materials, some of which are different from other layers. For example, in some embodiments, the sleeve can include an outer layer that comes into contact with dining-room surfaces. The sleeve can also include an inner layer that comes into contact with a container placed in the Caddy. In some embodiments, the inner layer can have insulating properties. Various layers of the sleeve can be made of materials such as fabric, vinyl, leather, plastic, metal, wood, or the like. One or more of the Sleeve layers may be waterproof, water-resistant, grease-proof, grease-resistant, proofed or resistant against absorbing or retaining other liquids. [0018] In some embodiments, the handles can be irreversibly attached to the sleeve. For example, where the sleeve is formed or constructed from a single piece of material, the handles can be formed or constructed out of the same piece of material. In some other embodiments, the handles can be reversibly or irreversibly attached to the sleeve via one or more various attachment means including, but not limited to, snap-buttons, zippers, adhesives, stitching, stapling, or the like. In some embodiments, the handles can be holding straps, lengths of cord or rope, other pieces of material, or the like. [0019] In some embodiments, the handles can be coupled to each other to form a handle assembly which may be formed or constructed from a single piece of material including, but not limited to, fabric, vinyl, leather, plastic, metal, wood, or the like. In some embodiments, some or all of the handle assembly or handles can extend on one or more sides of some or all portions that make up the sleeve. [0020] A handle assembly can extend along the outer layers of the sleeve, or between two or more layers of some or all portions that make up the sleeve. In some embodiments, part of the handle assembly extends along the inner layers of the side portions of the sleeve, while part of the handle assembly extends between the inner layer and outer layer of the bottom portion. The portion of the handle assembly which extends between two or more layers of a portion of the sleeve can be attached to one or more of the layers. In some embodiments, a part of the handle assembly that extends between the inner layer and outer layer of the bottom portion of a sleeve can be attached to the inner layer via stitching. In other embodiments, parts of the handle assembly are attached to both inner and outer layers via one or more forms of attachment including, but not limited to, stitching, stapling, adhesives, soldering, welding, or the like. [0021] In some embodiments, the various portions of the Caddy can be attached to each other using various forms of attachment. For example, in some embodiments where the Caddy includes two side portions and one bottom portion, the side portions can be attached to each other via stitching that extends through some or all layers of material that make of the side portions, and the side portions may be attached to the bottom portion via an adhesive. In some other embodiments, other forms of attachment or combinations thereof may be utilized, including, but not limited to, stapling, soldering, welding, or the like. [0022] In some embodiments, an additional piece of material covers the edge along which an attachment between two or more portions of the sleeve extends. For example, an attachment cover can extend along the edge between the side portions and the bottom portion, with stitching extending between one or more points on the attachment cover and through some or all of the layers that make up the side portions, bottom portion, or both. The attachment cover may be coupled to the portions by a different form of attachment. In some embodiments, the side portions are attached to the bottom portion via stitching, while the attachment cover can be attached to both portions via one or more of adhesives, stapling, another set of stitching, soldering, welding, or the like. [0023] In some embodiments, the sleeve of the Caddy can be sized to fit over the lower portion of a foodservice container in such a manner that the fit is snug, yet still enables the foodservice container to be removed from the Caddy with minimal effort. For example, in some embodiments the sleeve of the Caddy may be sized to fit snugly and removably over the lower portion of a bus tub, where the sleeve must ensure that the outer surfaces of the bus tub do not contaminate or otherwise damage or room surfaces, foodservice staff, consumers, or the like, yet also enable the bus tub to be quickly removed from the sleeve to unload dirty dishes or the like. In some other embodiments, the sleeve of the Caddy can be sized to fit loosely over the lower portion of a foodservice container such that the foodservice container can be removed from the Caddy as quickly as possible. For example, in some embodiments the sleeve of the Caddy may be sized to fit loosely over the lower portion of a serving tray, where the serving tray must be removed from the sleeve often. In other embodiments, the sleeve of the Caddy can be sized to fit tightly over the lower portion of a foodservice container such that the Caddy forms a tight seal around the lower portion of the foodservice container. For example, an insulated sleeve of the Caddy can be sized to fit tightly over the lower portion of a serving tray, where quick removal of the foodservice container from the Caddy is a lower priority. [0024] Referring first to FIG. 1 , embodiments of a Foodservice Container Caddy (“Caddy”) 102 are illustrated and discussed. FIG. 1 illustrates a perspective view 100 of Caddy 102 , which is adapted to receive part of container 103 , which has a lower portion 105 and an upper portion 107 . Caddy 102 can include a sleeve, made up of a bottom portion 104 and one or more side portions 106 , and two or more handles 108 . In some embodiments, the sleeve of Caddy 102 can have one or more of various types of shapes including, but not limited to, generally rectangular, circular, elliptic, hexagonal, some other polygonal shape, or the like. For example, in the illustrated embodiment, the sleeve of Caddy 102 has a generally rectangular shape. [0025] In some embodiments, bottom portion 104 and side portions 106 can include one or more layers of material. In the illustrated embodiment, side portions 106 include an inner layer 120 and an outer layer 116 . One or more layers can have certain properties including, but not limited to, waterproofing or water-resistance, liquidproofing or liquid-resistance, water-absorbance, impermeability to some or all elements or compounds, heat resistance, stain resistance, insulating properties, opacity, transparency, varying levels of translucence, or the like. [0026] In some embodiments, the layers that make up a bottom portion 104 or side portion 106 are attached to each other. In the illustrated embodiment, for example, the inner layer 120 and outer layer 116 that make up side portion 106 are attached to each other via stitching 114 that extends through both layers. In some embodiments, the layers can fold at or near the point of attachment. For example, in the illustrated embodiment, inner layer 120 and outer layer 116 of side portions 106 can be folded inwards upon themselves near the point of attachment such that stitching 114 can pass through each layer more than once. The point of attachment between two layers can vary in some embodiments. In the illustrated embodiment, the area of attachment between inner layer 120 and outer layer 116 on the side portions 106 is near the top edge of the side portion. Other forms of attachment to attach layers that make up a bottom portion 104 or side portion 106 , such as adhesives, stapling, soldering, welding, or the like, which may or may not extend partially or fully through one or more layers, exist between two or more layers, or attach one or more layers in another manner are contemplated and should be considered to be encompassed by the scope of this disclosure. [0027] In some embodiments, Caddy 102 is adapted to receive a container 103 . Container 103 can be a bus tub, a steam table pan, some other foodservice container, or the like. In some embodiments, Caddy 102 is configured to receive only a lower portion 105 of container 103 , leaving an upper portion 107 of container 103 to extend above the side portions 106 of Caddy 102 . For example, in some embodiments, the side portions 106 may extend only four inches above the bottom portion 104 , such that the Caddy 102 is adapted to receive a container 103 which features a combined height of the lower portion 105 and upper portion 107 that exceeds four inches. In some other embodiments, container 103 may feature a circumferential lip that extends substantially around part or all of the upper portion 107 of container 103 , and Caddy 102 can be configured to receive only the lower portion 105 of container 103 so that the circumferential lip remains above the side portions 106 of Caddy 102 . In some embodiments, Caddy 102 may be sized to fit over the lower portion 105 in such a manner that ensures a snug fit between Caddy 102 and container 103 yet enables container 103 to be quickly removed from the sleeve of Caddy 102 . In some other embodiments, Caddy 102 may be sized to fit more tightly or loosely over the lower portion 105 of container 103 . [0028] Where more than one side portion 106 make up the sides of Caddy 102 , side portions 106 can be attached to each other via one or more forms of attachment. In the illustrated embodiment, for example, two side portions 106 are attached to each other via stitching 118 that can extend through one or more layers of one or both side portions 106 . Other forms of attachment to attach side portions 106 , such as adhesives, stapling, soldering, welding, or the like, which may or may not extend partially or fully through one or more side portions 106 , exist between two or more side portions 106 , or attach one or more side portions 106 in another manner are possible and should be considered to be encompassed by the scope of this disclosure. [0029] Handles 108 can be formed or constructed of a single length of fabric that is looped back upon and attached to itself, via stitching, adhesive, stapling, or some other method, to form a single handle assembly that extends adjacent to at least one layer that makes up bottom portion 104 and side portion 106 . In some other embodiments, handles 108 can be formed or constructed of a single piece of material formed or constructed from a mold, cast, or the like. In some embodiments, a handle assembly can be formed or constructed from one or more pieces of material. For example, in the illustrated embodiment, a handle assembly is formed or constructed from two handles 108 and two straps (not shown) which are stitched together. The straps in the illustrated embodiment extend below bottom portion 104 and are attached to the inner layer 120 of bottom portion 104 via stitching 110 , which can extend partially or fully through one or more layers of bottom portion 104 and partially or fully through the strap itself [0030] Where one or more of side portions 106 and bottom portion 104 are formed or constructed of more than one piece of material, some or all of the handle assembly can extend between layers that make up one or more side portion 106 and bottom portion 104 . For example, in the illustrated embodiment, bottom portion 104 is made up of an inner layer 120 (shown) and an outer layer (not shown), and the straps that are attached to handles 108 to make up a handle assembly, which are not shown but are denoted by stitching 110 , extend between the inner layer 120 and the outer layer (not shown) that make up bottom portion 104 . [0031] In some embodiments, one or more of side portions 106 and bottom portion 104 can include one or more layers that have insulating properties, including but not limited to some type of thermal insulation. For example and not by way of limitation, in some embodiments where side portions 106 and bottom portion 104 include an inner layer 120 and an outer layer 116 (not shown for bottom portion 104 ) that are attached to each other to make the sleeve of Caddy 102 , one or more layers of insulating material can be located between the inner layer 120 and the outer layer 116 . [0032] In some embodiments where Caddy 102 is used to receive a container 103 that has hot or cold outer surfaces, one or more layers of insulating material located in side portions 106 and bottom portion 104 can protect foodservice staff and other objects, surfaces, and the like from being burned, injured, damaged, or otherwise affected by the hot surfaces of container 103 . For example, in some embodiments where container 103 is a steam table pan, the surfaces of which may be hot, insulation layers in one or more of side portions 106 and bottom portion 104 can help protect the foodservice staff handling Caddy 102 and others from being affected by the hot surfaces of container 103 . Other types of insulation layers can make up one or more portions of Caddy 102 . For example, an inner layer 120 , an outer layer 116 , or both, making up one or more of side portions 106 and bottom portion 104 may have insulating properties. [0033] In some embodiments, side portions 106 are attached to bottom portion 104 to form a sleeve. In the illustrated embodiment, for example, side portions 106 are attached to bottom portion 104 via stitching 122 that extends one or more layers of one or both of the side portions 106 and bottom portion 104 . Other forms of attachment used to attach side portions 106 and bottom portion 104 are possible and should be considered to be encompassed by the scope of this disclosure. Such forms of attachment can include, but are not limited to, adhesives, stapling, soldering, welding, or the like and can extend partially or fully through one or more layers of the sleeve, lie between two or more of side portions 106 and bottom portion 104 , or attach one or more of side portions 106 and bottom portion 104 in some other manner. [0034] Furthermore, in some embodiments, an attachment cover 112 can cover the point of attachment between one or more of side portions 106 and bottom portion 104 . For example, in the illustrated embodiment, attachment cover 112 covers the point of attachment between side portions 106 and bottom portion 104 , with stitching 122 extending from one side of attachment cover 112 , through one or more layers of one or more of side portions 106 and bottom portion 104 , and, in some embodiments, to another side of attachment cover 112 (not shown). In some embodiments, an attachment cover 112 can protect the point of attachment between one or more portion from deteriorating due to friction, frequent impacts, thermal stresses, or the like. In some embodiments, an attachment cover 112 can be integrated into the attachment of side portions 106 to each other. [0035] Where some or all of the inner layer 120 of side portions 106 and bottom portion 104 is waterproof, water-resistant, grease-proof, grease-resistant, liquid-proof, liquid-resistant, or the like, Caddy 102 may be adapted to catch and trap liquids leaked from or on the outside of container 103 . For example, in embodiments where container 103 is a steam table pan, which may have steam condensate on its outer surfaces, the condensate could drain into the sleeve formed or constructed by side portions 106 and bottom portion 104 , thereby preventing such condensate from dripping onto other surfaces, including but not limited to dining room tables, floors, and upholstery. In some other embodiments, container 103 is a bus tub, which may have water, grease, or some other liquid on its outer surfaces. In such an embodiment, the liquid could drain into the sleeve formed or constructed by side portions 106 and bottom portion 104 , thereby preventing such liquid from dripping onto other surfaces, including but not limited to dining-room surfaces. In some such embodiments, Caddy 102 can be provided with an absorbent inner layer (not illustrated) that may or may not be removable. [0036] Referring to FIG. 2 , embodiments of a Foodservice Container Caddy (“Caddy”) are illustrated and discussed. FIG. 2 illustrates a cross-sectional width view 200 of the embodiment of Caddy 102 illustrated in FIG. 1 from near the midsection of Caddy 102 . FIG. 2 illustrates an embodiment of Caddy 102 where side portions 106 and bottom portion 104 that make up the sleeve of Caddy 102 are each made up of inner layer 120 , outer layer 116 , and an internal layer 204 , which in some embodiments has insulating properties. In some embodiments, the inner layer 120 on the bottom portion 104 may be different from, or be made of a different material than the inner layer 120 on one or more of the side portions 106 , and the outer layer 120 on the bottom portion 104 may be different from, or be made of a different material than the outer layer 120 on one or more of the side portions 106 . [0037] In some embodiments, some parts of the handle assembly illustrated and discussed in FIG. 1 can extend between layers that make up one or more of side portions 106 and bottom portion 104 . For example, as shown in the illustrated embodiment where the handle assembly illustrated and discussed in FIG. 1 includes handles 108 (not illustrated) and two straps 202 , the straps 202 can extend through bottom portion 104 between the inner layer 120 of bottom portion 104 and the outer layer 116 of bottom portion 104 . The straps 202 can, in some embodiments, be attached to one or more layers by stitching, stapling, adhesives, welding, soldering, or the like. In the illustrated embodiment, straps 202 are attached to the inner layer 120 of bottom portion 104 by stitching 110 that can extend partially or fully through straps 202 , but not the outer layer 116 . In some other embodiments, stitching 110 , or some other form of attachment, can be used to attach straps 202 to both the inner layer 120 and the outer layer 116 . In some other embodiments, straps 202 can extend between two other different layers that make up one or more of side portions 106 and bottom portion 104 . [0038] In some embodiments, as discussed above in FIG. 1 , bottom portion 104 and side portions 106 can be attached via stitching 122 that extends through one or more layers of one or more of side portions 106 and bottom portion 104 . For example, in the illustrated embodiment, bottom portion 104 and side portions 106 are attached via stitching 122 that extends through both the inner layer 120 and outer layer 116 of both a side portion 106 and the bottom portion 104 . In some embodiments, the stitching can also extend between one or more sides of attachment cover 112 . For example, in the illustrated embodiment, stitching 122 extends through two sides of attachment cover 112 . In some embodiments, the attachment cover 112 may not be present. In some other embodiments, other forms of attachment might be used to attach side portions 106 and bottom portion 104 including, but not limited to, stitching extending through one or more layers of side portions 106 and bottom portion 104 , stapling, adhesive between portions, and the like Inner layer 120 and outer layer 116 of side portions 106 can be attached via stitching 114 , as illustrated, by adhesive, by stapling, or by some other form of attachment. [0039] In some embodiments, internal layers 204 do not extend through an entire side portion 106 or bottom portion 104 . For example, in the illustrated embodiment, internal layers 204 do not extend throughout the entire interior of side portions 106 and bottom portion 104 between inner layer 120 and outer layer 116 , as some of the interior of bottom portion 104 is occupied by strap 202 and adjustment space for stitching 122 , 114 , and 110 . Some or all internal layers 204 of one or more of side portions 106 and bottom portion 104 can extend throughout the interior of side portions 106 and bottom portion 104 , such that the internal layer 204 is stitched, stapled, or attached in some other manner to one or more of the inner layer 120 or outer layer 116 , or both, that make up side portions 106 and bottom portion 104 . [0040] In some embodiments, a sleeve made up of side portions 106 and bottom portion 104 may be formed or constructed of a single piece of material, including, but not limited to, a single cut piece of fabric, a piece of material formed or constructed from a mold or cast, or the like. [0041] Referring to FIG. 3 , embodiments of a Foodservice Container Caddy (“Caddy”) 102 are illustrated and discussed. FIG. 3 illustrates a cross-sectional side view 300 of Caddy 102 in an embodiment where handle assembly 302 includes handles 108 and one strap 202 . In some other embodiments, additional straps 202 may be present and be attached, via stitching, stapling, adhesives, or some other form of attachment, to two or more handles 108 . Some embodiments of Caddy 102 may feature portions of strap 202 extending between inner layer 120 and outer layer 116 , or some other combination of one of the above layers and an internal layer (not shown) of some or all of one or more of side portions 106 and bottom portion 104 . For example, in the illustrated embodiment, strap 202 extends between inner layer 120 and outer layer 116 of bottom portion 104 , but strap 202 extends adjacent to the inner layer 120 of side portions 106 . In some other embodiments, strap 202 can extend adjacent to the outer layer 116 of side portions 106 . [0042] It will be understood that the Foodservice Container Caddy can include other components, elements, or interfaces without departing from the scope of the present disclosure. Furthermore, although particular embodiments have been discussed above, the disclosure is not limited to the disclosed embodiments, but includes subject matter encompassed by the scope of the appended claims. [0043] It will be understood that, although certain embodiments employing particular materials and forms of attachment are illustrated, other materials and forms of attachment can be used without departing from the present scope of the disclosure. For example, adhesives between materials can be used as a form of attachment. In addition, various arrangements of particular components can be employed to accomplish the same functions disclosed herein, also without departing from the present scope of the disclosure.

1a

CROSS REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 60/814,976 for “Method To Increase Electrode's Stability” filed on Jun. 19, 2006, and to U.S. Provisional Application No. 60/815,037 for “New Electrode Design” filed on Jun. 19, 2006, which are both incorporated herein by reference in their entirety. GOVERNMENT RIGHTS NOTICE This invention was made with government support under grant No. R24EY12893-01, awarded by the National Institutes of Health. The government has certain rights in the invention. FIELD OF THE INVENTION The present invention is generally directed to an electrode with increased stability and method of manufacturing the same. In particular the present invention is directed to a new electrode design. BACKGROUND OF THE INVENTION In 1755 LeRoy passed the discharge of a Leyden jar through the orbit of a man who was blind from cataract and the patient saw “flames passing rapidly downwards.” Ever since, there has been a fascination with electrically elicited visual perception. The general concept of electrical stimulation of retinal cells to produce these flashes of light or phosphenes has been known for quite some time. Based on these general principles, some early attempts at devising prostheses for aiding the visually impaired have included attaching electrodes to the head or eyelids of patients. While some of these early attempts met with some limited success, these early prosthetic devices were large, bulky and could not produce adequate simulated vision to truly aid the visually impaired. In the early 1930's, Foerster investigated the effect of electrically stimulating the exposed occipital pole of one cerebral hemisphere. He found that, when a point at the extreme occipital pole was stimulated, the patient perceived a small spot of light directly in front and motionless (a phosphene). Subsequently, Brindley and Lewin (1968) thoroughly studied electrical stimulation of the human occipital (visual) cortex. By varying the stimulation parameters, these investigators described in detail the location of the phosphenes produced relative to the specific region of the occipital cortex stimulated. These experiments demonstrated: (1) the consistent shape and position of phosphenes; (2) that increased stimulation pulse duration made phosphenes brighter; and (3) that there was no detectable interaction between neighboring electrodes which were as close as 2.4 mm apart. As intraocular surgical techniques have advanced, it has become possible to apply stimulation on small groups and even on individual retinal cells to generate focused phosphenes through devices implanted within the eye itself. This has sparked renewed interest in developing methods and apparatus to aid the visually impaired. Specifically, great effort has been expended in the area of intraocular retinal prosthesis devices in an effort to restore vision in cases where blindness is caused by photoreceptor degenerative retinal diseases; such as retinitis pigmentosa and age related macular degeneration which affect millions of people worldwide. Neural tissue can be artificially stimulated and activated by prosthetic devices that pass pulses of electrical current through electrodes on such a device. The passage of current causes changes in electrical potentials across visual neuronal membranes, which can initiate visual neuron action potentials, which are the means of information transfer in the nervous system. Based on this mechanism, it is possible to input information into the nervous system by coding the sensory information as a sequence of electrical pulses which are relayed to the nervous system via the prosthetic device. In this way, it is possible to provide artificial sensations including vision. One typical application of neural tissue stimulation is in the rehabilitation of the blind. Some forms of blindness involve selective loss of the light sensitive transducers of the retina. Other retinal neurons remain viable, however, and may be activated in the manner described above by placement of a prosthetic electrode device on the inner (toward the vitreous) retinal surface (epiretinal). This placement must be mechanically stable, minimize the distance between the device electrodes and the visual neurons, control the electronic field distribution and avoid undue compression of the visual neurons. In 1986, Bullara (U.S. Pat. No. 4,573,481) patented an electrode assembly for surgical implantation on a nerve. The matrix was silicone with embedded iridium electrodes. The assembly fit around a nerve to stimulate it. Dawson and Radtke stimulated cat's retina by direct electrical stimulation of the retinal ganglion cell layer. These experimenters placed nine and then fourteen electrodes upon the inner retinal layer (i.e., primarily the ganglion cell layer) of two cats. Their experiments suggested that electrical stimulation of the retina with 30 to 100 μA current resulted in visual cortical responses. These experiments were carried out with needle-shaped electrodes that penetrated the surface of the retina (see also U.S. Pat. No. 4,628,933 to Michelson). The Michelson '933 apparatus includes an array of photosensitive devices on its surface that are connected to a plurality of electrodes positioned on the opposite surface of the device to stimulate the retina. These electrodes are disposed to form an array similar to a “bed of nails” having conductors which impinge directly on the retina to stimulate the retinal cells. U.S. Pat. No. 4,837,049 to Byers describes spike electrodes for neural stimulation. Each spike electrode pierces neural tissue for better electrical contact. U.S. Pat. No. 5,215,088 to Norman describes an array of spike electrodes for cortical stimulation. Each spike pierces cortical tissue for better electrical contact. The art of implanting an intraocular prosthetic device to electrically stimulate the retina was advanced with the introduction of retinal tacks in retinal surgery. De Juan, et al. at Duke University Eye Center inserted retinal tacks into retinas in an effort to reattach retinas that had detached from the underlying choroid, which is the source of blood supply for the outer retina and thus the photoreceptors. See, e.g., E. de Juan, et al., 99 Am. J. Opthalmol. 272 (1985). These retinal tacks have proved to be biocompatible and remain embedded in the retina, and choroid/sclera, effectively pinning the retina against the choroid and the posterior aspects of the globe. Retinal tacks are one way to attach a retinal electrode array to the retina. U.S. Pat. No. 5,109,844 to de Juan describes a flat electrode array placed against the retina for visual stimulation. U.S. Pat. No. 5,935,155 to Humayun describes a retinal prosthesis for use with the flat retinal array described in de Juan. US Patent Application 2003/0109903 to Berrang describes a Low profile subcutaneous enclosure, in particular and metal over ceramic hermetic package for implantation under the skin. Current on electrode surfaces tends to flow mainly from the edge of the metal surface. This is called edge effect for stimulating electrodes. Edge effect can cause tissue damage due to uneven current distribution. This effect can be minimized for a given electrode by increasing the edge. Thin film techniques may not provide enough electrode materials on the electrode surface for chronic stimulation. Further, common electroplating technique presents stress problem that limits the plated layer to less than 1 μm. SUMMARY OF THE INVENTION The present invention is generally directed to an electrode with increased stability and method of manufacturing the same. In particular the present invention is directed to a new electrode design. The present invention provides electrode designs and methods for manufacturing electrodes with higher stability and improved adhesion of the electrode material on the substrate. One aspect of the present invention is an electrode array containing electrodes with different shapes. Another aspect of the present invention are electrodes with a clustered surface. The surface of an electrode is covered with an insulated material and openings are provided in the area of the electrode into the insulating material resulting in a cluster. Another aspect of the present invention are electrodes containing a grid on the surface comprising at least one metal and/at least one polymer. Another aspect of the invention is that the openings have different shapes. Another aspect of the present invention is a method of manufacturing an electrode with increased stability, comprising: a) depositing a metal layer on an base layer; b) applying photoresist layer on the metal layer; c) patterning the photoresist layer providing openings; d) electroplating the openings with metal; e) removing the photoresist layer leaving spaces; and f) filling the spaces with polymer. Another aspect of the present invention is a method of manufacturing an electrode with increased stability, comprising: a) depositing a metal layer on an base layer; b) applying a polymer layer on the metal layer; b) applying photoresist layer on the polymer layer; c) patterning the photoresist layer providing openings; d) electroplating the openings with metal; and e) removing the photoresist layer. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 depicts a SEM imaging (×2,500) of electroplated platinum filled with grids of insulation polymers; FIG. 2 depicts a spherical view of an electrode with micro sticks/posts; FIG. 3 depicts a process scheme for manufacturing electroplated sticks/posts and polymer filling; FIG. 4 a depicts a SEM imaging (×850) of polymer surface with patterned holes before Pt plating; FIG. 4 b depicts a SEM imaging (×850) of polymer surface with patterned holes after Pt plating; FIG. 5 depicts a process scheme for manufacturing electroplated sticks/posts and polymer filling; FIG. 6 depicts a spherical view of an electrode with mesh grid as fixture; FIG. 7 depicts an electrode with polymer rings as fixture; FIG. 8 depicts an electrode array with different shapes of fixtures. DETAILED DESCRIPTION OF THE INVENTION The present invention is generally directed to an electrode with increased stability and method of manufacturing the same. In particular the present invention is directed to a new electrode design. The present invention provides an electrode for an implantable electrode array with an improved current distribution and adhesion for neural stimulation electrodes. Sputtered thin film electrodes may not provide enough electrode material on the electrode array surface for chronic stimulation. The electrodes are too thin and smooth and dissolve easily. Electroplating adds more material to increase the life time of the electrode. The electrodes are thicker and more solid. However, high stress problems, such as cracking or delaminating, limit the plating thickness to <1 μm which is the thickness normal dense plating. According to the method of the present invention electrodes (Pt, Ir, Pd, IrO) were electroplated with a diameter of 50 μm-500 μm and a thickness of 2 μm-3 μm on a substrate, such as a polymer, like polyimide, silicone, peek or parylene, or mixtures thereof. One aspect of the invention is to provide a mesh or grid of a different metal, such as Ti, Zr, Ta or mixtures or alloys thereof, or a polymer, such as silicone, polyimide, peek or parylene or mixtures thereof. The mesh or grid has a height of 5 μm-35 μm, preferably 22 μm-27 μm. Another aspect of the invention includes an additional electroplating step on top of the mesh or grid. In this case an embedded mesh or grid can be obtained. Another aspect of the invention is to plate micro sticks with a dense structure on sputtered electrode surface as a support. As next step a porous and loose layer with low stress is applied on top of the electrode to cover the electrode surface. FIG. 1 depicts a SEM imaging (×2,500) of electroplated platinum filled with grids of insulation polymers. The electrode of platinum containing the grid of polymer can be produced according to the process shown in FIG. 3 . By adding insulated lines on the metal surface more edges are created. An increase of the edges minimizes the edge effect or electrical discharge. For example, an electrode surface has a metal disk with a diameter of d, the edge length is π*d. If an insulated cross is added on the metal surface, the edge length is increased from π*d to (4d+π*d), which is over 120% increase in edge length. For a square metal surface, it has a 100% increase from 4d to 8d. In thin-film electrodes added insulation lines also serve as a protector for the metal layer to hold it from delaminating. In thick-film electrodes, a cut on the electrode surface will provide similar effect as an insulated line. The impedance is much higher inside the cut due to lower conductivity of electrolyte, which will force current flow through the edge of the cut. FIG. 2 depicts a spherical view of an electrode with micro sticks/posts. First a sputtered metal layer 1 is provided, then micro stick/post 2 are produced and finally the gabs are filled in by polymer such as PDMS or epoxy wherein a plated soft low stress layer 3 is provide. The process is shown in FIG. 3 and in FIG. 5 . Thin-film techniques can't provide enough electrode materials on the electrode surface for chronic stimulation. By electroplating a layer of electrode material on sputtered metal layer increases array's life time to several folds. However, normal electroplating technique presents stress problem that limited the plated layer to <1 μm. 2-3 μm thick of metal layer is successfully plated on thin-film Pt electrode with disk opening up to 500 μm. Micro sticks of Au and Pt can be plated up to 25 μm. There are several methods to reduce stress in plated metal layer according to the present invention which include: 1. Optimizing plating conditions to increase plated layer to 4-5 μm: surface pre-treatment (include cleaning or surface modification, redox status), surfactant, solution concentration, complex compounds, temperature, pH, stirring, current or voltage control (amplitude, waveform and frequency), or gas purge. 2. Plating micro sticks with dense structure on the electrode surface as support structure, then plate a porous and loose layer with low stress to cover the electrode surface. 3. Plating 2-3 μm thick of metal layer, then sputtering a mesh (or grid) of Ti to fix or hold the plated layer. Repeating above step until desired thickness (layer) is obtained. Each plated layer will be softer than the layer below. Top layer can be a porous material such as Pt black. 4. Add grids of polyimide on sputtered Pt surface. Then plate soft Pt on sputtered surface. The polyimide grids will separate or isolate plated surface and reduce stress. Materials for sticks can be same as or different from plated surface layer. For example, stick is dense Pt and plated layer is Pt black; or stick is Pt and plated layer is IrOx; support mesh grid can be metal or polymer, such as Ti or polyimide. The metal for electroplating the posts can be Pt, Ir, Au, Ru, Pd, or alloys thereof. FIG. 3 depicts a process scheme for manufacturing electroplated sticks/posts 3 and polymer filling 2 . In particularly six steps of the process are shown. In step I a thin film 5 of Pt, Ir, Au, Ru, Pd, or alloys thereof is applied by sputtering on a substrate 4 . In step II a polymer 6 covering the edge of the electrode is applied. In step III a photoresist layer 7 is applied and a patterning by MEMS is performed whereby holes 8 are created. The holes 8 are filled with electroplated metal 9 like Pt in step IV. In step V the photoresist 7 is removed leaving spaces 10 between the metal sticks or posts 9 . The spaces 10 between the sticks are filled with polymer 11 adhesive such as PDMS or epoxy in step VI. The obtained electrode is the electrode shown in FIG. 2 with micro stocks FIG. 4 a depicts a SEM imaging (×850) of polymer surface with patterned holes 8 before Pt plating 9 as shown in step III. FIG. 4 b depicts a SEM imaging (×850) of polymer surface with patterned holes after Pt plating 9 as shown in step IV. FIG. 5 depicts a process scheme for manufacturing electroplated sticks/posts 3 and polymer filling 2 . In particularly three steps of the process are shown. In step I to be seen as cross sectional view and top view a thin film 5 of Pt, Ir, Au, Ru, Pd, or alloys thereof is applied by sputtering on a substrate 4 . In step II a polymer 6 covering the edge of the electrode is applied and is patterned whereby holes 8 are created. The holes 8 are filled with electroplated metal 9 like Pt in step III. The obtained electrode is the electrode shown in FIG. 2 with micro sticks 3 and polymer 6 in the spaces. FIG. 6 depicts a spherical view of an electrode with mesh grid as fixture. First a sputtered metal layer 11 is provided, then a low stress layer 22 is plated and a grid is obtained and filled with a polymer like polyimide, silicone, peek or parylene, or mixtures thereof or metal Pt, Ir, Au, Ru, Pd, or alloys thereof to create a mesh grid 23 . The steps can be repeated to apply a second low stress layer 32 which is plated and a grid is obtained and filled with a polymer like polyimide, silicone, peek or parylene, or mixtures thereof or metal Pt, Ir, Au, Ru, Pd, or alloys thereof to create a mesh grid 33 are produced and finally the gabs are filled in by polymer such as PDMS or epoxy wherein a plated soft low stress layer 3 is provide. The process is shown in FIG. 3 and in FIG. 5 . FIG. 7 depicts an electrode with polymer rings as fixture. This is an alternative to the mesh grid as shown in FIG. 6 . The rings can be polymer rings or exposed metal. A multi-ring electrode is achieved by selectively insulating a conductive pad in a appropriate pattern concentric rings such as to leave exposed concentric rings of metal in between successively larger isolation rings. Novel design feature are small circles radially patterned in the metal pad exposing the substrate material. These circles serve as anchor points for the adhesion of the insulation rings to the substrate. FIG. 8 depicts an electrode array with different shapes of fixtures. Circle shapes, star shapes, square shapes and rings are shown in the electrode array. Each of the shapes contains overlapping edges and mesh grids. This presents a series of new electrode geometries that control charge transfer characteristics by the strategic use of edges and corners to concentrate current delivery. These designs are an improvement on conventional surface electrode designs which are typically circles. The present invention will be further explained in detail by the following example. EXAMPLE General Procedure Platinum Plating Solution Preparation 0.3 g sodium dihydrogen phosphate (NaH 2 PO 4 ) and 6.03 g disodium hydrogen phosphate (Na 2 HPO 4 ) [Fluka] were dissolved in 100 ml deionized water, and stirred by magnetic stirring for 30 minutes. The concentrations for NaH 2 PO 4 and Na 2 HPO 4 were 25 mM and 425 mM. Then 0.5 g of Platinum chloride (PtCl 4 ) [Alfa Aesar] was added to the phosphate solution to form the platinum salt concentrations of 15 mM. The solution was then stirred for 30 minutes. Different concentrations of (PtCl 4 ) were used in the experiments and the range of Pt salt concentrations was from 3 to 30 mM. The pH of the solution was measured at 7.9. The color of the solution was amber. The solution was deaerated before the plating process by bubbling nitrogen through the solution. Preparation of the Substrate A thin-film platinum polyimide array was used for platinum plating. The array included 16 electrodes with 200 μm thin-film Pt disk as exposed electrode surface. All the electrodes in the array were shorted to common contact points for the plating. The Pt disk electrodes were first electrochemically cleaned by bubbling the surface with oxygen at +2.8V vs Ag/AgCl in 0.5 M H 2 SO 4 for 10 sec. Then the surface was cleaned by bubbling with hydrogen at −1.2 V vs Ag/AgCl in 0.5 M H 2 SO 4 for 15 sec to remove surface contaminations and polymer residues. Electroplating Cell A classical Pyrex glass three-electrode reaction cell was used for the electroplating. The reference electrode compartment was separated from the reaction compartment by a Vicor porous frit, in order to avoid the migration of concentrated KCl and AgCl from the inner filling solution of the reference electrode to the plating bath. The counter electrode was a platinized-platinum sheet of a real surface area equal to 1.8 cm 2 . A digital magnetic stirrer (Dataplate PMC720) was used to agitate the solution during plating. The solution temperatures were from 15° C. to 80° C. and were controlled by a VWR circulating water bath with a digital temperature controller (VWR 1147P). The potential was controlled by using an EG&G PARC model 273 potentiostat-galvanostat and the response current, current density and charge were recorded by EG&G PARC M270 software. The charge/charge density and average plating current/current density were calculated by integrating the area under the plating current vs. time curve. The plating time was from 1 minute to 60 minutes. Platinum Plating A platinum polyimide electrode array having 16 electrodes (FIG. 14) having a diameter of 200 μm platinum disc on the array was cleaned electrochemically in 0.5 M H 2 SO 4 . The electrode array was placed in an electroplating cell containing a plating solution having a concentration of 15 mM platinum chloride in 0.025 M sodium dihydrogen phosphate and 0.425 M disodium hydrogen phosphate. The plating bath temperature was at 22° C. A constant voltage of −0.525 V vs Ag/AgCl reference electrode was applied on the electrode and terminated after 10 minutes. The electrode array was thoroughly rinsed in deionized water. The charge/charge density and average plating current/current density were calculated by integrating the area under the plating current vs. time curve. The current density was near linearly increased from initial 11.1 A/cm 2 to final 15.2 A/cm 2 . The electrochemical capacitance of the electrode array with the surface coating of rough platinum was 1462 μF/cm 2 , measured in a 10 mM phosphate buffered saline solution. The thin-film Pt disks only have an average capacitance of less than 20 μF/cm 2 before plating measured at the same condition. The optimal voltage drop across the electrodes for producing rough platinum was from −0.4 to −0.7 Volts vs. Ag/AgCl reference electrode. The plated platinum surface coating thickness is about 3.5 μm. The electrochemical active surface area increase is about 73 fold. The relation of surface area to the thickness of the platinum surface coating is 4.18 F/cm 3 [surface coating of rough platinum 1462 μF/cm 2 per thickness of the platinum coating of 3.5 μm.] The platinum surface coating adhesive strength was 55 mN. Procedure On a glass substrate, a 5 μm polyimide was spin coated on. A thin-layer Pt (˜5000 A) is sputtered then coated with polyimide having a thickness of about 5 μm with openings ranged from 30 μm to 400 μm. On each sample, 16 such openings are exposed as electrode surfaces for plating. A photoresist mask is coated on these electrode openings with some holes patterned. The electrode sample was electrochemically cleaned in 0.5 M sulphric acid by applying a dc voltage to cause water hydrolysis. Then the sample was rinsed with DI water thoroughly. 150 ml glass beakers are used as the electroplating cell. A large surface area Pt sheet was used as a common electrode (anode). The reference electrode was an Ag/AgCl electrode (silver-silver chloride electrode). About 100 ml of 18 mM Ammonium hexachloroplatinate in phosphate buffer solution was used to plating Pt. Arrange the electrode in the test cell, so that the plating electrode (cathode) is in parallel with the common electrode (anode). The reference electrode is positioned beside the cathode. Add the plating solution with specified concentration. Turn on the magnetic stirrer. The solution agitation is controlled by a magnetic stirrer (VWR Thermolyne Cimarec 1). The typical plating temperature was about 24-26° C. A voltage waveform (1 ms pulse width square wave) is generated by HP 33120A arbitrary waveform generator, which is converted to current signal through a FHC isolator. The pulse current is a square wave at 500 Hz with a 1 ms pulse width. Apply this pulse current on the plating electrode vs anode. The electrode voltage vs Ag/AgCl reference electrode is monitored using an oscilloscope (Tektronix TDS3014B Oscilloscope). The current amplitude was adjusted so that the cathodic peak voltage reaches about −0.6V vs Ag/AgCl reference electrode. During plating, the electrode voltage tends to decrease with plating time. The current amplitude is frequently adjusted so that the electrode voltage is kept within −0.5 to −0.7 V range vs Ag/AgCl reference electrode. When specified plating time is reached, terminate the current pulse. Rinse the cathode in DI water thoroughly. The photoresist mask was dissolved in solvent to leave electroplated Pt posts exposed on the thin film metal surface. The plated samples are profiled to measure the height of the plated posts. The plated posts have a height of 8 μm, ranging from 4 to 25 μm. The gaps around the Pt posts were then filled with a layer of PDMS or polyimide. The final sample was examined under a microscope. After plating, the current amplitudes are averaged for the whole plating time. It is found that the charge density increases exponentially with sample opening decrease. The smaller the sample openings, the higher the charge density required. Accordingly, what has been shown is an improved flexible circuit with an electronics control unit attached thereto, which is suitable for implantation in living tissue and to transmit electrical impulses to the living tissue. Obviously, many modifications and variations of the present invention are possible in light of the above teachings. It is therefore to be understood that, within the scope of the appended claims, the invention may be practiced other than as specifically described.

1a

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] The present invention relates generally to trousers and specifically to trousers in which the center line closely approximates the center line of the human leg from the thigh to ankle with both a pivoting and aligning method of forming the trousers. [0003] 2. Description of the Prior Art [0004] Trousers (pants) generally comprise two tubes of material connected at the top. These tubes form the legs of the garment and the material at the top of each tube forms the hip area. In their simplest form, the tubes are each straight. However, the mature human leg is not. Rather, in a normal standing position, when viewed from the front, the thigh bone (femur) angles inward such that an upper thigh bone portion is positioned near an outside of the pelvis and a lower thigh bone portion is positioned at the knee. This angle, known as a bicondylar angle, is between eight (8) and fourteen (14) degrees in humans. The lower leg is, thus, not positioned directly below the femur in a normal standing position, when viewed from the front. In short, the thigh bones and lower leg bones are angled inward and backward with respect to the center of each thigh. Thus, the center line (“crease”) of the conventional pant leg aligns but cannot pivot with the center line of the lower leg. Unless an alteration is made, the pants will remain tubes contrary to the anatomy of the leg. [0005] Tailors and fashion designers have accounted for the differences between the natural center lines of the upper and lower legs in a number of ways. The conventional ways of aligning the center lines involve breaking the outer seam. However, it is often desirable to maintain the integrity of the outer seam such as in the case of traditional blue jeans which comprise a selvedge outer seam. A selvedge seam is a self-finished edge of fabric that prevents the fabric from unraveling or fraying. Selvedge seams run parallel to the warp, the longitudinal threads extending along the length of the fabric. Denim jeans comprising selvedge edges are considered by many to be highly desirable. However, there is a need for a pair of jeans or other trousers comprising a selvedge edge, the jeans/trousers being better fitting and comprising a center of thigh line that pivots and aligns with the center of knee line. [0006] The present disclosure provides a novel pair of trousers and method in which a two dimensional cutting of the pattern moving both the center of the pant leg to center of leg and providing a second dimensional move, a pivoting backward angle of the lower leg. SUMMARY OF THE INVENTION [0007] A novel pair of trousers and method are provided, the trousers comprising a centerline generally aligning with a centerline of a wearer's leg. The trousers comprise a diagonal upper seam, a diagonal lower seam, and a selvedge or straight grain outer seam. The diagonal upper seam extends downward from a position near an inside hip line to the centerline above the knee. The lower seam extends diagonally upward from the trouser bottom to the centerline above the knee. [0008] The trouser blank used to form the trousers of the present disclosure comprises a selvedge outer seam. Prior to slits being made and material repositioned, the vertical center of the thigh line and vertical center of knee line are not aligned. The present disclosure provides a pair of trousers and method for forming same, in which these lines are more closely aligned as a result of one or more slits being formed in a garment blank and the fabric repositioned. [0009] In one embodiment, an initial slit and a lower slit are formed. In other embodiments, an initial slit, a lower slit, and one or more intermediate slits are formed. When lower leg material adjacent to the lower slit is moved from a first lower leg material position to a second lower leg material position, upper leg material below the initial slit is moved from a first upper leg material position to a second upper leg material position. The upper leg material on either side of the initial slit can then be sewn to form a “dart”, or a fold in the fabric rather than the slit. These movements have the effect of moving the vertical knee center line to a position more aligned with the vertical thigh center line. Moreover, these changes also permit greater mobility and comfort for the wearer. BRIEF DESCRIPTION OF THE DRAWINGS [0010] FIG. 1 is a side elevation view of a prior art pair of trousers. [0011] FIG. 2 is a side elevation view of the trousers, in accordance with a preferred embodiment. [0012] FIG. 3 is a plan view of a trouser blank comprising a selvedge edge, a vertical center of thigh line, a horizontal hip line, a horizontal knee line, and a vertical center of knee line. [0013] FIG. 4 is a plan view of the trouser blank of FIG. 3 , in accordance with a preferred embodiment, showing the Initial cuts made to the blank. [0014] FIG. 5 is a plan view of the trouser blank of FIG. 4 , depicting the initial cuts and positioning of fabric after the cuts, in accordance with a preferred embodiment. [0015] FIG. 6 is a plan view of the trouser blank after material repositioning. [0016] FIG. 7 is a front elevation view of the trousers, in accordance with a preferred embodiment. DESCRIPTION OF THE PREFERRED EMBODIMENT [0017] Referring to FIGS. 2-7 , there is shown the initial garment blank 8 ( FIG. 3 ), an improved garment blank ( FIGS. 4, 5 , & 6 ), and trousers 12 formed from such blanks 8 , in accordance with a preferred embodiment. As used herein, the terms “a” or “an” shall mean one or more than one. The term “plurality” shall mean two or more than two. The term “another” is defined as a second or more. The terms “including” and/or “having” are open ended (e.g., comprising). The term “or” as used herein is to be interpreted as inclusive or meaning any one or any combination. Therefore, “A, B or C” means “any of the following: A; B; C; A and B; A and C; B and C; A, B and C”. An exception to this definition will occur only when a combination of elements, functions, steps or acts are in some way inherently mutually exclusive. [0018] Reference throughout this document to “one embodiment,” “certain embodiments,” “an embodiment,” or similar term means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present disclosure. Thus, the appearances of such phrases in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner on one or more embodiments without limitation. The detailed description illustrates by way of example, not by way of limitation, the principles of the invention. This description will clearly enable one skilled in the art to make and use the invention, and describes several embodiments, adaptations, variations, alternatives, and uses of the invention, including what is presently believed to be the best mode of carrying out the invention. [0019] General Overview [0020] FIG. 1 depicts a conventional prior art pair of trousers with a crease line 17 comprising a lower crease line 17 L, upper crease line 17 U, and a conventional seam line 21 . The crease line 17 of the conventional trousers generally runs parallel to the conventional seam line 21 . [0021] FIG. 2 depicts a novel pair of trousers 12 comprising fabric 10 . The novel pair of trousers 12 results from a first movement of the lower crease line 17 L to a vertical center of knee line 18 and a second movement of the lower crease line 17 L towards the rear of the lower leg 25 to form a new lower crease line 17 LN. When viewed from the front, the vertical center of knee line 18 is an imaginary vertical line that conceptually comprises the position on the fabric 10 at which, when assembled, approximately one half of the wearer's knee would be positioned on one lateral side, and the other half of the wearer's knee on the other lateral side. [0022] Referring to FIG. 3 , an initial garment blank 8 for the novel pair of trousers 12 is shown. In accordance with the present disclosure, the blank 8 comprises fabric 10 , a selvedge outer seam 14 , an upper edge 38 , a crotch 24 , an inner edge 34 , and a lower edge 38 . The blank 8 further comprises a vertical center of thigh line 16 , the vertical center of knee line 18 , a horizontal knee line 20 , and a horizontal hip line 22 . The vertical center of thigh line 16 is an imaginary line that, when viewed from the front, conceptually comprises the position on the fabric 10 at which approximately one half of a wearer's thigh would be positioned on one lateral side, and the other half of the wearer's thigh on the other lateral side. [0023] In the preferred embodiment, the fabric 10 is denim. However, the fabric 10 need not be denim. Rather, the fabric 10 may be duck or other suitable weave and may be formed from cotton, wool, synthetic fibers, or other conventional and commercially available material. [0024] As may be seen in FIGS. 3-5 , the vertical center of thigh line 16 and vertical center of knee line 18 are not aligned. As may be seen in FIG. 1 , in a conventional pair of pants, the crease line 17 is vertical the entire length of the pants and generally parallel to the conventional seam line 21 . This configuration results in undesirable gatherings 19 in the fabric 10 . [0025] Referring to FIG. 4 , in order to more closely align the vertical center of thigh line 16 and vertical center of knee line 18 , and to cause the crease line 17 and selvedge seam 14 to more closely approximate the backward angle of the leg 23 , one or more slits 26 , 28 , 30 a , 30 b are formed such that the fabric 10 may be repositioned. In the preferred embodiment, an initial slit 26 is cut on the crotch 24 side of the blank 8 and extends downwardly from a juncture 32 of the crotch 24 and inner edge 34 to the vertical center of thigh line 16 at a position approximately ¾ of the way down from the horizontal hip line 22 . As may be seen in FIG. 4 , in the preferred embodiment, a lower slit 28 extends from a lower edge 38 position approximately midway between the inner edge 34 and the vertical center of knee line 18 to a position on the vertical center of knee line 18 approximately midway between the lower edge 38 and the horizontal knee line 20 . [0026] Although in the preferred embodiment, the initial slit 26 extends from the juncture 32 of the crotch 24 and inner edge 34 to the vertical center of thigh line 16 at the position approximately ¾ of the way down from the horizontal hip line 22 , and the lower slit 28 extends from the lower edge 38 position approximately midway between the inner edge 34 and the vertical center of knee line 18 to a position on the vertical center of knee line 18 approximately midway between the lower edge 38 and the horizontal knee line 20 , the initial and lower slits 26 , 28 may begin and end at different positions without departing from the scope and spirit of this disclosure. For example, the initial slit 26 may begin at a position closer to the horizontal knee line 20 and extend at a different angle to a position further from the vertical center of thigh line 16 . The lower slit 28 may begin nearer or further from the inner edge 34 and extend at a different angle to a position further from the vertical center of knee line 18 . [0027] In some embodiments one or more intermediate slits 30 a , 30 b may be formed. In one embodiment, a lower intermediate slit 30 a extends upwardly at an angle from an end of the lower slit 28 to a position approximately ¾ of the way between the lower edge 38 and horizontal knee line 20 . In one embodiment, an upper intermediate slit 30 b extends downwardly at an angle from an end of the initial slit 26 to a position approximately ¾ of the way between the horizontal hip line 22 and horizontal knee line 20 . [0028] Referring to FIG. 5 , after the one or more slits 26 , 28 , 30 a , 30 b are formed, lower slit material 46 on the crotch 24 side of the lower slit 28 is repositioned from a first position 40 to a second position 42 (defined by the lower diagonal line 42 ). In some embodiments, central material 48 between positions 40 and 42 may be removed. In some embodiments, the central material 48 is folded to form a dart. Whether the central material 48 between positions 40 and 42 is removed or folded, the lower slit material 46 is secured to selvedge side material 50 in a conventional manner such as with stitching. [0029] Referring to FIG. 6 , the movement of the lower slit material 48 from the first position 40 to the second position 42 results in the vertical center of knee line 18 being moved to a resulting vertical center of lower leg line 44 . As may be seen in FIG. 6 , such vertical center of lower leg line 44 is more closely aligned with the vertical center of thigh line 16 . Referring to FIG. 7 , when worn by the wearer, the vertical center of thigh line 16 generally aligns with the vertical center of a wearer's thigh and the vertical center of lower leg line 44 generally aligns with the vertical center of a wearer's lower leg. [0030] Referring again to FIG. 5 , after the lower slit material 46 is moved from the first position 40 to the second position 42 , initial slit material 52 is repositioned from a first position 54 to a second position 56 (defined by the upper diagonal line 56 ). In the preferred embodiment initial central material 58 between positions 54 and 56 is folded into a seam comprising a diagonal seam 57 comprising a dart 62 ( FIG. 7 ). In other embodiments, the initial central material 58 is removed. Whether the initial central material 58 between positions 54 and 56 is removed or folded, initial slit material 52 is secured to inner edge material 60 in a conventional manner such as with stitching. [0031] Referring to FIG. 7 , the blank 8 , as modified in the manner discussed herein, is then used to form a pair of trousers 12 comprising a diagonal upper seam 57 and a vertical lower seam 45 . The modified blank 8 may be sewn together with a similarly modified blank 8 to form the front and back of a pants leg. The pants leg may be coupled with a similarly formed pants leg to form the pants of a pair of trousers 12 . The modified blank 8 may be sewn to an unmodified blank 8 or blank 8 modified in a different manner than that described herein. A zipper 64 , waist band 66 , belt loops 68 , button 70 , pocket 72 , and other finishing elements found in conventional trousers may be added to form the trousers 12 . [0032] The method of making trousers 12 comprises the steps of providing a garment blank 8 , the blank 8 comprising fabric 10 , a selvedge outer seam 14 , an upper edge 36 , a crotch 24 , an inner edge 34 , and a lower edge 38 ; the blank 8 further comprising vertical center of thigh line 16 , vertical center of knee line 18 , horizontal knee line 20 , and horizontal hip line 22 ; making an initial slit 26 extending from a juncture 32 of the crotch 24 and inner edge 34 to the vertical center of thigh line 16 ; making a lower slit 28 extending from a lower edge 38 position approximately midway between the inner edge 34 and the vertical center of knee line 18 to a position on the vertical center of knee line 18 approximately midway between the lower edge 38 and the horizontal knee line 20 ; after making the initial and lower slits 26 , 28 , repositioning lower slit material 46 from a first position 40 to a second position 42 ; securing the lower slit material 46 to selvedge side material 50 ; after the lower slit material 46 is moved from the first position 40 to the second position 42 , repositioning the initial slit material 52 from a first position 54 to a second position 56 ; forming a seam 57 which may comprise a dart with the initial slit material 52 ; using the modified blank 8 to form a pair of trouser comprising an unbroken selvedge edge 14 . [0033] In some embodiments of the method, one or more intermediate slits 30 a , 30 b are formed. In one embodiment of the method, a lower intermediate slit 30 a extends upwardly at an angle from an end of the lower slit 28 to a position approximately ¾ of the way between the lower edge 38 and horizontal knee line 20 . In one embodiment, of the method, an upper intermediate slit 30 b extends downwardly at an angle from an end of the initial slit 26 to a position approximately ¾ of the way between the horizontal hip line 22 and horizontal knee line 20 . [0034] In some embodiments of the method, central material 48 between positions 40 and 42 is removed. In some embodiments, the central material 48 is folded to form a dart. [0035] In some embodiments of the method, the initial central material 58 is removed. [0036] While there has been illustrated and described what is, at present, considered to be a preferred embodiment of the present invention, it will be understood by those skilled in the art that various changes and modifications may be made, and equivalents may be substituted for elements thereof without departing from the true scope of the invention. Therefore, it is intended that this invention not be limited to the particular embodiment disclosed as the best mode contemplated for carrying out the invention, but that the invention will include all embodiments falling within the scope of this disclosure.

1a

BACKGROUND OF THE INVENTION [0001] The treatment of chronic disease often requires repeated and prolonged access to a patient's vascular system to, e.g., to administer medications, blood products, nutrients and other fluids and/or to withdraw blood. When such procedures must be frequently repeated, it may be impractical and/or dangerous to insert and remove the catheter and the needle for each session. In this case, a semi-permanent catheter, (e.g., a peripherally inserted central catheter (PICC)), may be used. As would be understood by those skilled in the art, a PICC is a catheter that is inserted in a vein at a peripheral location, such as the arm or leg and threaded through the vein to the chest, in proximity to the heart. [0002] To simplify the insertion process and reduce patient discomfort, PICCs and other semi-permanent catheters are generally made small and thin. Accordingly, their structural strength is limited by the thickness and type of material forming the catheter's walls. The amount of pressure and flow rate that the catheter can support without damage is also limited. If the maximum pressure the catheter can withstand (the burst pressure) or the maximum flow rate is exceeded, the catheter may be damaged or may completely fail possibly spilling fluids from the catheter into the body. During high pressure injections, escaping fluid may also damage the surrounding tissues. [0003] Modern medical procedures rely considerably on visualization techniques to diagnose and treat diverse conditions. Some of these techniques include the injection of a contrast media to the vascular system to improve visualization of blood vessels and other biological structures during fluoroscopy, radiology, or other imaging. The contrast media is generally a liquid that is opaque to the visualization method used, so that body lumens containing the media appear distinct from other tissues. Typically, contrast media is introduced using a separate catheter designed to withstand the high injection pressures and flow rates necessary to disperse the media throughout the organs of interest. For example in the case of fluoroscopy, the contrast media may be a substance opaque to X-ray radiation. More modern visualization methods such as, for example, enhanced computed tomography (CT) may require the introduction of different contrast media, as would be understood by those skilled in the art. [0004] Conventional PICC catheters are unable to withstand the high pressures and flow rates associated with the introduction of visualization media which are often substantially above what is used for the infusion of medications. Thus, it is often necessary to insert one or more additional catheters dedicated to the contrast media increasing patient discomfort and the time and costs associated with the procedure. If the patient exhibits poor peripheral venous access, the insertion of an additional contrast media catheter may be difficult. SUMMARY OF THE INVENTION [0005] In one aspect, the present invention is directed to a catheter for medical procedures comprising a shaft portion having a distal end insertable into a body lumen, the shaft portion including a wall defining a working lumen extending therewithin and a first strengthening element coupled to the wall to increase a burst pressure of the shaft portion, wherein the first strengthening element cooperates with a base material of the wall to define a flexible region of the shaft portion allowing the shaft portion to be atraumatically inserted into the body lumen. BRIEF DESCRIPTION OF THE DRAWINGS [0006] FIG. 1 is a cross sectional view showing a first embodiment of a venous access catheter with layered materials, according to the present invention; [0007] FIG. 2 is a cross sectional view showing a second embodiment of a venous catheter with layered materials, according to the present invention; [0008] FIG. 3 is a cross sectional view showing a third embodiment of a venous catheter with a braid, according to the present invention; [0009] FIG. 4 is a cross sectional view showing a further embodiment of a venous catheter having a braid and layered materials, according to the present invention; [0010] FIG. 5 is a cross sectional view showing another embodiment of a venous catheter having an externally placed braid; [0011] FIG. 6 is a cross sectional view showing a different embodiment of a venous catheter having a micro-particle reinforcement; [0012] FIG. 7 is a perspective view showing a venous catheter partially reinforced according to the invention; and [0013] FIG. 8 is a perspective view showing a venous catheter with exemplary designed failure points. DETAILED DESCRIPTION [0014] The present invention may be further understood with reference to the following description and the appended drawings, wherein like elements are referred to with the same reference numerals. The invention is related to medical devices used to introduce a contrast media fluid into a patient, preferably at high pressure and with a large flow rate. Specifically, the devices according to the invention may be used to inject the contrast media using a PICC. [0015] As described above, where repeated access to the vascular system is required, a semi-permanent central venous catheter may be inserted in a vein kept in place for up to two years. A PICC typically comprises a flexible elongated portion tunneled from a remote peripheral location (an arm or leg) to a location near the heart. The proximal end of the PICC may be accessed via a port placed, for example, subcutaneously in the arm or chest of the patient or which may remain outside of the body. [0016] As would be understood by those skilled in the art, the pressure exerted by the fluid is a function of the flow rate, the viscosity and the cross sectional flow area of the catheter, among other variables. Accordingly, limitations on the fluid pressure and/or flow rate are often specified for various types of catheters to ensure that the catheter will not be damaged during use by excessive strains. However as mentioned above, modern imaging methods often rely on the introduction of contrast fluids at high flow rates. [0017] The catheter according to the present invention, may be used for both central venous access and the injection of contrast media decreasing patient discomfort and the time and expense of procedures. The catheter according to this invention, e.g., a PICC venous catheter, is at least partially reinforced to enhance its burst pressure and maximum flow rate to levels suitable for the introduction of contrast media without compromising kink resistance or increasing the cross sectional profile of the catheter, as compared to conventional PICC devices. [0018] For example, a catheter according to the present invention will withstand a flow rate of about 4 to about 6 cc/sec and a pressure of more than about 300PSI typical of power injection devices. A reinforcement is included in the exemplary catheter according to the invention to increase the burst pressure. In one embodiment, both the shaft of the catheter and an extension tube thereof are reinforced, to give a substantially uniform resistance to the increased pressure. Alternatively, only the shaft may be reinforced. [0019] FIG. 1 shows an exemplary embodiment of a catheter comprising a reinforced portion in accord with the present invention. The exemplary catheter 100 is a dual lumen catheter in which the lumens 110 are separated by a partition 108 extending along a longitudinal axis of the catheter 100 . In the exemplary embodiment, the catheter 100 has a layered construction, in which layers of stronger material are formed near layers of more flexible material to obtain desired mechanical characteristics of an outer wall 102 . For example, an outer layer 104 of a material having a lower durometer value may be used, to retain the flexibility of a conventional catheter. Materials such as members of the polyurethane family that are alcohol compatible may be used advantageously in this function. An inner portion 106 of the catheter shaft wall 102 may be made of a material with a higher durometer value, to give strength to the composite assembly. For example, high strength thermoplastic polyurethanes, polyether block-amides and polyolefines may be used. [0020] It is often necessary, in the course of a catheterization procedure, to adjust the length of the portion of the catheter inserted into the patient. Generally, the surgeon cuts a distal portion of the catheter to a desired length. Thus, in the case of a catheter 100 reinforced according to the present invention, the reinforcing material is preferably selected so that it can be easily cut with a blade. The exemplary materials described above fall within this category, so that the reinforced catheter 100 may be cut to a desired length using conventional methods. Alternatively, a material that is more difficult to cut may be used and/or a portion of the catheter 100 may be left unreinforced so that it may be cut. For example, the weakest portions of the catheter, such as the portion immediately distal to the suture wing, may be reinforced, leaving a 20-40 cm section of the tip of the catheter unreinforced. Because the portion immediately distal to the suture wing is one of the weakest and most likely to fail, reinforcement around the weak areas will prevent most failures from occurring. The unreinforced section of the catheter will continue to permit surgeons to easily cut the catheter in conventional manners, such as with a blade. [0021] According to the present embodiment, the catheter 100 may be composed of various layers with each layer being formed of a material of different hardness, thereby allowing the catheter 100 to be atraumaticly inserted while exhibiting an improved resistance to the pressures associated with high flow rate power injection. As would be understood by those skilled in the art, the manufacture of the catheter 100 may be accomplished using a co-extrusion or a lamination process. For example, the softer, more flexible outer layer 104 of the shaft wall 102 may be co-extruded with the stiffer, higher durometer inner layer 106 . This configuration provides both the flexible outer portion and the pressure resistant inner portion of the catheter 100 . [0022] The co-extrusion process may be carried out with polymers that are either compatible or non-compatible with one another. If non compatible polymers are used, it may be necessary to provide an intermediate tie layer along an interface 112 between the outer layer 104 and the inner layer 106 . In this exemplary embodiment, a soft thermoplastic polyurethane (TPU) may be used for the outer layer 104 while a stiff polyester block-amide (PEBA), a stiff polyether block-amide, polyolefin or polytetrafluoroethylene (PTFE) may be used for the inner layer 106 . The outer TPU exhibits softening while within the body, giving the desired flexibility, etc., and allowing atraumatic insertion. However the PEBA of the inner layer 106 retains its inherent strength and resistance to pressure. [0023] FIG. 2 shows a second embodiment of the catheter 120 according to the invention. In this exemplary embodiment, the shaft wall 122 is reinforced by an inner layer 126 of a material with greater durometer values. Here, instead of an entire inner portion of the shaft 120 formed of a higher durometer material as in the example of FIG. 1 , both the inner layer 126 and the outer layer 124 are formed of lower durometer, more flexible material. Specifically, the outer layer 124 of the wall 122 as well as the inner core 132 of a lumen divider 128 are formed from one piece of the lower durometer material. To this basic catheter shaft is then added a coating of higher durometer material on the inner sides of the two lumens 110 , forming the inner layer 126 of the wall 122 as well as outer portions 130 of the divider 128 . This embodiment provides for a flexible outer surface of the catheter 120 , together with increased mechanical reinforcement of the stiffer lining of the dual lumens 110 . Alternatively, the inner layers 126 , 130 may be part of a separate tube of smaller diameter which is inserted into, but not bonded to the shaft of the catheter 120 . [0024] A further exemplary embodiment of a catheter shaft according to the invention is shown in FIG. 3 . In this case, the increased resistance to fluid pressure within the lumens 110 is provided by a braid included therewithin. As shown, the catheter 140 includes an outer wall 142 comprising a braid 144 , shown here in cross section. The braid 144 may be formed of any of a variety of materials, depending on the amount of additional pressure resistance desired. The braid 144 may be formed, for example, of a metal or alloy such as Nitinol or stainless steel. A material having shape memory properties may be especially well suited for reinforcement braids used in extension tubes of the catheter. In use, the proximal ends of these catheters are clamped shut between uses. Thus, the reinforcing braid will preferably be selected so that it will not retain the clamped shape, but will return to the original tubular shape when the clamping force is released. As would be understood by those skilled in the art, for catheters which are to be used in conjunction with MRI, the braid 144 is preferably formed of a non-ferro-magnetic material, for example, kevlar, vectran, silk, members of the polyolefin family and other types of polymer or other suitable material. [0025] A variation of the braid reinforcement is shown in cross section in FIG. 4 . The exemplary embodiment shown there comprises a braid 154 together with a dual material layered construction of the wall 152 . The catheter shaft 150 includes two lumens with an inner portion 156 of the wall 152 formed of a material having an increased durometer with respect to a material comprising an outer portion 158 thereof. All of the variations in design described above with respect to the embodiments of FIGS. 1-3 may also be applied to the construction of the exemplary catheter shaft 150 . It will be apparent to those of skill in the art that the radial location of the braid 154 within the wall 152 of the catheter shaft 150 may also be varied. It will also be apparent that the same reinforced construction methods described herein may be used for other components of a catheter, such as extension tubes, or for other medical tubes. [0026] In a different embodiment, the reinforcement braid may be disposed on the outside of the catheter body. For example, FIG. 5 shows a dual lumen catheter 160 having an outer wall 162 and a braid 164 disposed outside the surface of the wall 162 . This configuration may provide manufacturing benefits compared to a configuration in which the braid 164 is embedded within the material of the catheter wall. For example, the braid 164 may be added to the assembly after the catheter has been formed by extrusion. The braid 164 may then be bonded to the catheter wall 162 , or may be left free to slide longitudinally relative to the catheter. In this latter embodiment, the user may be allowed to longitudinally move the external braid to a desired position. [0027] To further improve the pressure resistance and ultimate hoop strength of the base catheter material, micro particles may be added to the compound forming the catheter wall. The micro particles (sometimes referred to as nano-particles, depending on their size) may include clay and fumed silica. FIG. 6 shows an exemplary embodiment, in which a catheter shaft 170 is formed with a wall 172 comprising strengthening particles 174 . The presence of the micro particles 174 increases the radial stiffness of the catheter wall 172 , resulting in a more durable and more pressure resistant base material for the catheter. The distribution of the micro particles 174 both radially and longitudinally along the catheter 170 may be selected to obtain desired mechanical properties of the device. For example, a more pliable section of the catheter may be formed by locally reducing the amount of micro particles 174 added to the material of wall 172 while areas of increased stiffness may be created by increasing the amount of micro particles 174 in a region. [0028] As an alternative to introducing strengthening particles into the catheter material, cross linking agents may be incorporated into the base material of the catheter shaft. For example, agents such as silanes, dicumyl peroxide, maleic anhydride and functionalized polymers may be added. These agents are effective in partially cross-linking thermoplastic polymers. Activation of the cross linking agents may be accomplished in a conventional manner, for example through secondary exposure to high energy sources such as electron beams to increase the strength of the base material. As indicated above, both the radial and tangential distribution of cross linking agents through the material of the catheter shaft may be selected to obtain desired mechanical properties, as would be understood by those skilled in the art. [0029] It will be apparent to those of skill in the art that the various methods described herein to increase the strength of a catheter shaft wall may be applied selectively to certain portions of the catheter in question. For example, FIG. 7 shows a catheter shaft 200 having a reinforced portion 204 and an unreinforced portion 202 . The reinforced portion 204 may comprise any of the reinforcement elements or treatments described above, such as a mesh 206 embedded within wall 208 of the catheter shaft 200 . It will be apparent to those of skill in the art that different types or combinations of reinforcements may be used, such as an external mesh, a layered multi-material composite structure, or the addition of reinforcing particles in the wall material. In the example depicted in FIG. 7 , the shaft wall 208 is altered along its length, in the longitudinal direction. However, for different applications, the variation in structural reinforcement may be carried out in the angular direction or in the radial direction, as was described above. The non-uniform reinforcement construction may be applied to both catheter shaft and to the extension tubes, as needed. [0030] In one exemplary application, the longitudinal variation in the strength of catheter wall 208 may be used to allow the user to trim the distal end of the catheter shaft 200 , to provide a better fit in the patient. Leaving the unreinforced portion 202 without the reinforcement elements 206 included elsewhere (i.e., in reinforced portion 204 ) to increase pressure resistance allows the user to cut the wall 208 more easily, The reinforcement elements 206 may thus be selected to have greater strength, since it is not necessary that the user be able to cut therethrough to trim the catheter shaft 200 to the desired length. In one example, between about 15 cm and 20 cm of the distal end of catheter shaft 200 may form the unreinforced portion 202 . [0031] In another exemplary application, the wall of shaft 200 may be composed of varying materials, or may be otherwise reinforced by different amounts along its length to allow for increased strength and durability at specified stress points. These points of increased stress may occur during power injection of a fluid only at certain locations, such as near the injection point or near bends in the catheter. In this manner, the additional material used to strengthen the catheter may be targeted where it is most effective, without having to reinforce the entire catheter. This construction may be simpler and less costly than forming a catheter with reinforcements along its entire length. [0032] According to another exemplary embodiment of the invention, the catheter shaft or the extension tube may be constructed with an inherent weak point designed to fail before the rest of the device does. When the catheter experiences excessive pressure, the extension tube will fail and release the pressure, leaving the catheter shaft intact. The extension tube may be formed with a tapered region of lesser strength, or by profiling the wall thickness of the tube to create the designated failure point. As shown in FIG. 8 , a catheter extension tube 250 comprises a reduced thickness portion 252 in which the wall 254 is much thinner and is, at this point, able to withstand a pressure reduced with respect to the rest of the catheter. It will be apparent to those skilled in the art that the wall thickness reduction may be achieved by removing material from the outside of the wall (as shown), the inside of the wall or both. [0033] In another embodiment, the inherent weak point may be formed by making either or both of the inside and outside diameters of the tube irregular in cross section. The non uniform wall thickness thus created, for example in the extension tube, defines specific sites for failure of the tube. As shown in the example of FIG. 8 , a rectangular inner profile 256 of the extension tube 250 may be placed within a generally circular extension tube 250 . This configuration may be used to define four thin walls 258 at the corners of the profile 256 , which will tend to fail before thicker portions of the wall. In addition, the corners 260 act as stress concentrators, further ensuring that the extension tube 250 will fail at the location of the rectangular profile 256 when subject to excessive pressure. It will be apparent to those skilled in the art that the rectangular profile 256 may be used separately or in conjunction with the reduced thickness portion 252 , as desired in specific applications. [0034] The present invention has been described with reference to specific embodiments, and more specifically to a PICC catheter used for power injection of contrast media used in CT imaging. However, other embodiments may be devised that are applicable to other medical devices and procedures, without departing from the scope of the invention. Accordingly, various modifications and changes may be made to the embodiments, particularly with regard to dimensions and materials, without departing from the broadest spirit and scope of the present invention as set forth in the claims that follow. The specification and drawings are accordingly to be regarded in an illustrative rather than restrictive illustrative rather than restrictive sense.

1a

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation of U.S. patent application Ser. No. 14/292,488 filed May 30, 2014, now U.S. Pat. No. 9,039,582, which is a continuation of U.S. patent application Ser. No. 13/857,051 filed Apr. 4, 2013, now U.S. Pat. No. 8,764,616, which is a continuation of U.S. patent application Ser. No. 12/858,233 filed Aug. 17, 2010, now U.S. Pat. No. 8,419,597, which claims the benefit of U.S. Provisional Application No. 61/234,547 filed Aug. 17, 2009, all of which are incorporated herein by reference in their entirety. FIELD OF THE DISCLOSURE [0002] Disclosed herein are systems and methods for a hill training apparatus for a bicycle trainer. The systems and methods disclosed herein enable cyclists to simulate hill resistance, incline, decline, and body positioning while riding on a bicycle trainer for improved training purposes. BACKGROUND OF THE DISCLOSURE [0003] Cyclists use stationary bicycle trainers for training due to inclement weather, time constraints, and convenience and to achieve specific athletic objectives, such as performing controlled drills to improve their cycling performance. Most commonly cyclists attach their own bicycle to a portable trainer; however, occasionally they may use a stationary bicycle. [0004] Most existing bicycle trainers consist of an apparatus that attaches to the rear wheel of the cyclist's bicycle in order to apply resistance which can vary throughout the workout. Additionally, most often, the front wheel sits in a simple rest, or the front wheel is removed and the front fork of the bicycle is mounted to a component of the trainer in order to support the front of the bicycle, which remains stationary during the workout. Stationary bicycles use the same method of applying resistance to the rear wheel to vary the difficulty of the workout. [0005] Many indoor bicycle manufacturers provide compatible software programs that incorporate “virtual reality” effects where the user views a rider on a screen in front of him and the resistance applied to the bicycle on the trainer increases as the rider on the screen approaches a hill. Some of the programs also incorporate a steering option for the rider to simulate cornering while viewing the rider on the screen cornering right or left. These virtual reality programs use an increase in resistance applied to the rear wheel to simulate the increasing workload of an uphill effort and a decrease in resistance to simulate the decreasing workload of downhill effort. [0006] U.S. Pat. No. 5,279,529 (the '529 patent) uses existing torque or resistance generators (load generators) to increase and decrease workload resistances in simulating incline and decline riding. It describes a pedal platform apparatus that simulates uphill or downhill riding, and focuses on assisting with cycling while in the standing cycling position. The '529 patent also provides for changing pedal positioning. [0007] U.S. Pat. No. 4,976,424 (the '424 patent) allows for adjustable incline and decline of the front wheel achieved by manually positioning the fork mount for the purpose of creating a ‘slight uphill’ position for the comfort of the cyclist. The '424 patent simulates uphill and downhill resistance by adjusting the force applied via a resistance generator. To maintain constant resistance, the front fork support described in U.S. Pat. No. 4,976,424 moves in response to the cyclist's shifting weight to keep the back wheel in contact with the resistance rollers. [0008] U.S. Patent Publication. No. 2002/20107114 (the '114 publication) allows for automatic inclination and declination of the front of the trainer to simulate uphill and downhill riding. To achieve inclination and declination of the front of the trainer the '114 publication describes utilizes a telescoping frame of a stationary bike which in turn raises and lowers the pedal height position. [0009] U.S. Pat. No. 7,303,510 (“the '510 patent) allows for automatic inclination and declination of the front wheel of a bicycle using an elevator assembly and a wheel support assembly that is operatively coupled to the elevator assembly. To achieve proper declination of the front wheel to simulate downhill orientation, the '510 patent requires the use of elevation legs to support the bicycle some distance above the ground when in level orientation. In addition, the '510 patent provides for the wheel support assembly to be modified to attach to the bicycle's front fork through the use of a fixedly attached cylinder approximating a wheel axle. By fixedly attaching the bicycle's front fork to the wheel support assembly the horizontal movement of the fork in relation to the elevator assembly is removed. Without this horizontal movement, the ability to raise or lower the front fork of the bicycle is negated. [0010] While these references provide some features to enhance bicycle trainers, there is still room for improvement in bicycle training devices. For example, none of these approaches allow for the simulation of hill training addressing resistance, incline, decline, and body positioning. In addition, none of these approaches allows for the simulation of decline hill training and body positioning without the need for additional components to raise the bicycle off the ground. SUMMARY OF THE DISCLOSURE [0011] Disclosed herein are systems and methods that allow the simulation of hill training addressing resistance, incline, decline, and body positioning. Embodiments disclosed herein allow a rider to simulate the biomechanical orientation characteristic of incline and decline outdoor hill cycling using a bicycle trainer while maintaining a fixed pedal position in relation to the bicycle frame. The bicycle trainer allows for automatic or manual incline and decline adjustment. Embodiments described herein can also allow for seated or standing training, incorporate extreme degrees of inclination and declination, allow for the cyclist to use their personal bicycles, and can be portable and require minimal effort to install, assemble, and use. Systems and methods disclosed herein achieve these benefits by raising or lowering the front of a bicycle using a rod's movement in a direction that does not match the directional movement of the front of the bicycle. The systems and methods can also be applied to the back of a bicycle. [0012] Particularly, one embodiment disclosed herein includes an apparatus for a hill training stationary portable bicycle trainer comprising: a connecting rod; and a slider, slidably supported by a surface, wherein the connecting rod links the slider to a front fork and/or front wheel of a bicycle, wherein force applied to the slider causes the slider to slide along the surface altering the angle of the connecting rod and operating to raise or lower the front fork and/or front wheel of the bicycle. [0013] Another embodiment includes an apparatus for a hill training stationary portable bicycle trainer comprising: a crank; a coupler; and a pivot, wherein the coupler links the crank to a front fork and/or front wheel of a bicycle through the pivot, wherein when torque is applied to the crank it alters the angle of the pivot causing the front fork and/or front wheel of the bicycle to raise or lower. [0014] Another embodiment includes an apparatus for a hill training stationary portable bicycle trainer comprising: a rod; a slider; and a pivot; wherein the slider operatively connects the rod to a front fork and/or front wheel of a bicycle and, wherein the rod is operatively connected to the pivot such that torque applied to the rod causes the rod to rotate about the pivot such that the slider raises or lowers thereby raising or lowering the front fork and/or front wheel of the bicycle. [0015] Embodiments disclosed herein can further comprise a rear mounting apparatus attached to the rear hub of the bicycle such that substantially no translation of the hub occurs in the vertical or horizontal direction. In another embodiment, the rear mounting apparatus measures the angular velocity of the hub and/or a rear wheel of the bicycle. In another embodiment, the rear mounting apparatus measures a cyclist's cadence. In another embodiment, the rear mounting apparatus provides resistance to the hub and/or a rear wheel of the bicycle. [0016] Embodiments disclosed herein also include methods. Particularly, one method includes a method of adjusting the elevation of the front or back end of a bicycle comprising adjusting a rod's movement in a plane wherein the rod and the front or back end of the bicycle are linked and wherein movement of the rod is not parallel to the movement of the front or back end of the bicycle. This method can be used with the apparatus embodiments disclosed herein. BRIEF DESCRIPTION OF THE FIGURES [0017] FIGS. 1A and 1B depict a side view of features of a hill training apparatus described and referred to herein as an R-R-R-P implementation or embodiment. FIG. 1A shows a side view schematic of an R-R-R-P embodiment, and FIG. 1B depicts the corresponding kinematic structure. [0018] FIGS. 2A and 2B depict a side view of features of a hill training apparatus described and referred to herein as an R-R-R-R mechanism or embodiment. FIG. 2A shows a side view schematic of an R-R-R-R embodiment, and FIG. 2B depicts the corresponding kinematic structure. [0019] FIGS. 3A and 3B depict a side view of features of a hill training apparatus described and referred to herein as an R-R-P-R mechanism or embodiment. FIG. 3A shows a side view schematic of an R-R-P-R embodiment, and FIG. 3B depicts the corresponding kinematic structure. [0020] FIGS. 4A-4E depict a side view of a bicycle attached to a hill training apparatus described herein. FIG. 4A shows a side view of an embodiment of the disclosure. FIG. 4B shows the apparatus of FIG. 4A in a downhill position. FIG. 4C shows the apparatus of FIG. 4A in an uphill position. FIG. 4D shows a side view schematic of an R-R-P-P embodiment, and FIG. 4E depicts the corresponding kinematic structure. DETAILED DESCRIPTION [0021] Previous bicycle trainers provide some features to enhance the training they achieve. There is still room for improvement, however, in bicycle training devices. For example, previous approaches did not allow for the simulation of decline hill training and body positioning without the need for additional components to raise the bicycle off the ground. [0022] The presently-disclosed systems and methods provide for the simulation of hill training addressing resistance, incline, decline, and body positioning. Embodiments disclosed herein allow a rider to simulate the biomechanical orientation characteristic of incline and decline outdoor hill cycling using a bicycle trainer while maintaining a fixed pedal position in relation to the bicycle frame. The bicycle trainer allows for automatic or manual incline and decline adjustment. Embodiments described herein can also allow for seated or standing training, incorporate extreme degrees of inclination and declination, allow for the cyclist to use their personal bicycles, and can be portable and require minimal effort to install, assemble, and use. Systems and methods disclosed herein achieve these benefits by raising or lowering the front of a bicycle using a rod's movement in a direction that does not match the directional movement of the front of the bicycle. Accordingly, no additional components are required to achieve the desired downhill positioning and the mechanisms to achieve this positioning do not interfere with the front of the bicycle. The following non-limiting and exemplary embodiments are provided. [0023] One embodiment of the systems and methods disclosed herein is depicted in FIG. 1A with the corresponding kinematic structure is shown in FIG. 1B . In this embodiment, link 1 is the ground (K), link 2 is the bicycle frame (HE), link 3 is the connecting rod (EL), and link 4 is the slider (M). This embodiment has one degree of freedom. The orientation of the bicycle frame (HE) can be manipulated by applying a horizontal force to the slider (M). Such a force will cause the connecting rod (EL) to move and thus effect a change in the orientation of the bicycle frame (HE). Particularly, movement of the slider (M) towards the back of the bicycle lowers the front of the bicycle. Movement of the slider (M) towards the front of the bicycle raises the front of the bicycle. This movement is achieved because slider (M) is connected to sufficiently rigid connecting rod (EL). As can be seen, in this embodiment, no additional components are required to elevate the bicycle to achieve this downhill position and the mechanism to achieve it does not unduly limit the downhill angle that can be achieved. This embodiment can be referred to as an R-R-R-P implementation. [0024] Another embodiment, referred to as an R-R-R-R mechanism, is shown in FIGS. 2A (schematic) and 2 B (kinematic). FIG. 2 depicts a ‘four-bar’ (four link) mechanism. In this embodiment, the ground is link 1 , the bicycle frame (HE) is link 2 , the coupler (EN) is link 3 , and the crank (O) is link 4 . This mechanism also has one degree of freedom. One approach to manipulating the orientation of the bicycle frame is to control the angle of the crank (O). For example, a torque applied to the crank (O) will cause a change in the orientation of the bicycle frame (HE). In particular exemplary embodiments adjusting the crank (O) towards the front of the bicycle brings coupler (EN) forward raising the front of the bicycle, while adjusting the crank (O) towards the back of the bicycle brings coupler (EN) backwards, lowering the front of the bicycle. Again, in this embodiment, no additional components are required to elevate the bicycle to achieve this downhill position and the mechanism to achieve it does not unduly limit the downhill angle that can be achieved. [0025] Yet another embodiment, referred to herein as the R-R-P-R mechanism, is shown in FIGS. 3A (schematic) and 3 B (kinematic). In this embodiment, link 1 is the ground (K), link 2 is the bicycle frame (HE), link 3 is the slider (J), and the rod (Q) is link 4 . This embodiment has one degree of freedom. The manipulation of the bicycle frame (HE) can be accomplished by applying a torque to the rod (Q) about the pivot (S). Such a torque will cause the rotation of the rod (Q) and as a result the orientation of the bicycle frame (HE) must change so as to satisfy the loop closure condition. [0026] While the previous exemplary embodiments require no additional components to elevate the bicycle to achieve the described downhill positions and the mechanisms to achieve these positions do not unduly limit the downhill angle that can be achieved, it should be understood that the embodiments described above can also be used in combination with previously-used approaches. An example is depicted in FIGS. 4A-4E . In this example, the entire hill training apparatus rests on the ground (K). The figure shows the bicycle in the level position (i.e., neither up hill nor down hill). In this schematic the bicycle's front wheel (C) is removed, and hence is represented by the dashed circle. [0027] The bicycle's front fork (E) is attached to an apparatus (F) via slider (J). The apparatus (F) is used to raise and lower the front fork (E) of the bicycle so as to simulate cycling up or down a hill. FIG. 4B shows the bicycle trainer of FIG. 4A in the downhill position. To obtain this configuration the apparatus (F) translates downwards, (i.e. in the −y direction) and the slider (J) translates backwards, (i.e. in the −x direction). FIG. 4C shows the bicycle trainer of FIG. 4A in an uphill position. To obtain this configuration the apparatus (F) translates upwards, (i.e. in the +y direction) and the slider (J) translates backwards, (i.e. in the −x direction). [0028] The +/−y direction motion generated by the apparatus (F) can be realized using previously-known devices including, without limitation: telescoping hydraulic or pneumatic cylinders; direct drive linear translation motors; a rack and pinion system driven by a rotational motor; or a Scotch yoke mechanism. As described above, the apparatus (F), in conjunction with the slider (J), allows the bicycle frame to rotate about the hub (H). While this embodiment allows for inclination and declination of the bicycle to simulate the biomechanical orientation characteristic of outdoor hill cycling using a bicycle trainer, the kinematic behavior can be realized more effectively using the alternate kinematic structures above in FIGS. 1-3 . [0029] FIGS. 4A-4E describe additional features that can also be used with the embodiments disclosed in FIGS. 1-3 . For example, FIG. 4A depicts a rear mounting apparatus (A) attached to the rear wheel of the cyclist's bicycle (B). A computer control panel (I) is connected to the rear mounting apparatus (A) and to the apparatus (F). Notwithstanding FIG. 4 , in certain embodiments, the computer control panel (I) can be mounted on the bicycle handle bar. [0030] In some embodiments, the rear mounting apparatus (A) can attach to the hub (H) of the cyclist's bicycle. Embodiments disclosed herein can also be modified so that the rear wheel (B) and/or the hub (H) is raised and lowered by apparatus (F) or according to the embodiments depicted in FIGS. 1-3 above rather than the front wheel (C). Those of ordinary skill in the art understand these modifications and they are not discussed in detail herein. [0031] As the cyclist pedals the back wheel (B) rotates about the hub (H). The rear mounting apparatus (A) can provide several functions including, without limitation: ensuring that the hub (H) does not translate in the horizontal direction (x), or the vertical direction (y), relative to the ground (K); measuring the angular velocity of the back wheel, which can be used to determine the effective translational speed of the cyclist; measuring the cadence of the cyclist; and providing resistance to the back wheel (B) and/or hub (H). [0032] The computer control panel (I) can be used to perform various tasks, including, without limitation: sensing and recording the angular velocity of the back wheel (B); sensing and recording the cadence of the cyclist; computing the effective translational velocity of the cyclist; sensing and recording the height of apparatus (F); and regulating the height of apparatus (F) so as to put the cyclist in an uphill, level, or downhill orientation. [0033] In addition, using the effective translational velocity of the cyclist, the computer control panel can be used to determine the instantaneous height of the apparatus (F) so as to simulate cycling on a specific hill. [0034] To begin a kinematic analysis for a hill training apparatus as described herein, note that in all orientations of the bicycle the hub (H) does not translate significantly or at all. That is, the hub (H) does not substantially move in the horizontal or vertical direction relative to the ground (K). Hence, the hub (H) can be treated as a stationary point (affixed to the ground (K)). Moreover, the bicycle frame is assumed to be sufficiently rigid, thus the distance between the hub (H) and the fork (E) is functionally constant in all orientations of the bicycle in the hill training apparatus. Embodiments disclosed herein can be modified, however, such that the hub (H) translates to move vertically and/or horizontally relative to the ground (K). In such modified embodiments, the front fork (E) would not substantially translate and would therefore be treated as a stationary point. [0035] FIG. 4E is a kinematic representation of a hill training apparatus under the assumptions stated above. This is a four link mechanism that forms a closed kinematic chain. The links that make up the mechanism are as follows. Link 1 is the ground (K), link 2 is the bicycle frame, represented by HE, link 3 is the slider (J), and link 4 is the apparatus (F). Based on this diagram, one of ordinary skill in the art will note that links 1 and 2 are connected via a revolute (or turning) pair (R). See Fabien, B. C., Analytical System Dynamics: Modeling and Simulation , Springer, 2009:64-73). This is because link 2 (the bicycle frame (HE)) can rotate relative to the link 1 (the ground (K)) about the hub (H). Links 2 and 3 are connected by a revolute pair (R). This is because link 2 (the bicycle frame (HE)) can rotate relative to the slider (J) about the front fork (E). Links 3 and 4 are connected by a prismatic (or sliding) pair (P). This is because link 3 (the slider (J)) can only translate in the horizontal direction relative to link 4 (apparatus (F)). Finally, links 4 and 1 are connected by a prismatic pair (P). This is because link 4 (apparatus (F)) can only translate in the vertical direction relative to the ground (K). Thus, in this realization the hill training apparatus is called an R-R-P-P mechanism. [0036] The mobility of this mechanism can be established using Gruebler's equation ([1], pp. 70). Specifically, the number of degrees of freedom (DOF) for this mechanism is given by [0000] DOF = λ  ( l - j - 1 ) + ∑ i = 1 j  f i , ( 1 ) [0000] where λ=3 for motion in a plane, I is the number of links in the mechanism, j is the number of joints in the mechanism, and fi is the number of degrees of freedom allowed at the i-th joint. Therefore, the R-R-P-P mechanism shown in FIGS. 4D and 4E have [0000] DOF=3(4−4−1)+4=1 [0000] That is, the mechanism has one degree of freedom. By regulating any one of the degrees of freedom at the joints the bicycle frame (HE) can be placed in an arbitrary orientation. [0037] For example, the height of the apparatus (F) can be controlled to manipulate the orientation of the bicycle frame (HE). If apparatus (F) is a hydraulic cylinder, applying a force via the cylinder will cause the front fork (E) to be raised (or lowered). [0038] Unless otherwise indicated, all numbers expressing numerical values and so forth used in the specification and claims are to be understood as being modified in all instances by the term “about.” Accordingly, unless indicated to the contrary, the numerical parameters set forth in the specification and attached claims are approximations that may vary depending upon the desired properties sought to be obtained by the present invention. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. [0039] Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. Any numerical value, however, inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements. [0040] The terms “a,” “an,” “the” and similar referents used in the context of describing the invention (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. Recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein. All methods disclosed herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., “such as”) provided herein is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the invention. [0041] Groupings of alternative elements or embodiments of the invention disclosed herein are not to be construed as limitations. Each group member may be referred to and claimed individually or in any combination with other members of the group or other elements found herein. It is anticipated that one or more members of a group may be included in, or deleted from, a group for reasons of convenience and/or patentability. When any such inclusion or deletion occurs, the specification is deemed to contain the group as modified thus fulfilling the written description of all Markush groups used in the appended claims. [0042] Certain embodiments of this invention are disclosed herein, including the best mode known to the inventors for carrying out the invention. Of course, variations on these described embodiments will become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventor expects skilled artisans to employ such variations as appropriate, and the inventors intend for the invention to be practiced otherwise than specifically disclosed herein. Accordingly, this invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the invention unless otherwise indicated herein or otherwise clearly contradicted by context. [0043] Specific embodiments disclosed herein may be further limited in the claims using consisting of or and consisting essentially of language. When used in the claims, whether as filed or added per amendment, the transition term “consisting of” excludes any element, step, or ingredient not specified in the claims. The transition term “consisting essentially of” limits the scope of a claim to the specified materials or steps and those that do not materially affect the basic and novel characteristic(s). Embodiments of the invention so claimed are inherently or expressly described and enabled herein. [0044] In closing, it is to be understood that the embodiments of the invention disclosed herein are illustrative of the principles of the present invention. Other modifications that may be employed are within the scope of the invention. Thus, by way of example, but not of limitation, alternative configurations of the present invention may be utilized in accordance with the teachings herein. Accordingly, the present invention is not limited to that precisely as shown and described.

1a

BACKGROUND OF THE INVENTION [0001] Plants are often treated by contacting them with compositions. For example, U.S. patent application Ser. No. 11/324,617 discloses treating non-citrus plants with compositions that contain at least one cyclopropene and that contain at least one plant growth regulator that is not a cyclopropene. It is desired to provide methods that involve treating certain specific crop plants at developmental stage or stages appropriate for those specific crop plants. Independently, it is also desired to provide methods of treating plants that result in an increase in the yield of the crop produced by those plants. [0002] Many inbred corn lines are especially susceptible to heat stress during early tassel formation and pollination. Other inbred corn lines are especially susceptible to drought stress during early to mid vegetative growth periods. Inbreds are also susceptible to the stress associated with the physical injury that occurs during the act of detasseling inbreds to be used as females. All of these situations result in exaggerated economic losses due to the weak nature of the inbreds and high value seed they produce. [0003] Thus, there remains a need for methods to enhance yield or seed production for stress-susceptible plant, including certain inbred corn lines. SUMMARY OF THE INVENTION [0004] This invention is based on the use of cyclopropene to stabilize/enhance yield/seed production for corn inbred lines known to be stress-susceptible. Inbred corn lines are especially susceptible to environmental and mechanical stresses. Provided are methods and use of cyclopropene to enhance production of inbred seed from inbreds especially susceptible to stress. Also provided are methods and use of cyclopropene to enhance production of hybrid seed from inbreds susceptible to environmental stress. Also provided are methods and use of cyclopropene to enhance production of hybrid seed from inbreds susceptible to mechanical stress. [0005] In one aspect, provided is method for improving the yield of a crop produced by a plurality of plants. The method comprises contacting said plants with a composition that comprises at least one cyclopropene compound, wherein the contacting is performed while the plants are in a location other than in a building, and the crop is susceptible to stress. [0006] In one embodiment, the location comprises an open field. In another embodiment, the location does not comprise an enclosed environment. In a further embodiment, the enclosed environment is a container or a greenhouse. [0007] In one embodiment, the composition is a liquid. In another embodiment, the composition comprises a complex of a cyclopropene compound and a molecular encapsulating agent. In another embodiment, the at least one cyclopropene compound comprises 1-methylcyclopropene (1-MCP). In a further or alternative embodiment, the molecular encapsulating agent is selected from alpha-cyclodextrin, beta-cyclodextrin, gamma-cyclodextrin, or combinations thereof. In a further embodiment, the molecular encapsulating agent comprises alpha-cyclodextrin. [0008] In one embodiment, the cyclopropene compound is of the formula: [0000] [0009] wherein R is a substituted or unsubstituted alkyl, alkenyl, alkynyl, cycloalkyl, cycloalkylalkyl, phenyl, or naphthyl group; wherein the substituents are independently halogen, alkoxy, or substituted or unsubstituted phenoxy. [0010] In a further embodiment, R is C 1-8 alkyl. In another embodiment, R is methyl. [0011] In another embodiment, the cyclopropene compound is of the formula: [0000] [0000] wherein R 1 is a substituted or unsubstituted C 1 -C 4 alkyl, C 1 -C 4 alkenyl, C 1 -C 4 alkynyl, C 1 -C 4 cycloalkyl, cylcoalkylalkyl, phenyl, or napthyl group; and R 2 , R 3 , and R 4 are hydrogen. [0012] In one embodiment, the stress comprises abiotic stress. Abiotic stress may include dehydration or other osmotic stress, salinity, high or low light intensity, high or low temperatures, submergence, exposure to heavy metals, and oxidative stress. In another embodiment, the stress comprises an environmental stress. In a further embodiment, the environmental stress comprises drought and/or heat. In another embodiment, the stress comprises mechanical stress. [0013] In one embodiment, the crop comprises an inbred corn line. In another embodiment, the contacting is performed during tassel formation and/or pollination of the crop. In another embodiment, the contacting is performed during early to mid vegetative growth periods of the crop. In another embodiment, the yield comprises seed production. In another embodiment, the yield may be improved at least 10%; from 10% to 25%; from 10% to 30%; from 10% to 50%; from 20% to 40%, or from 20% to 50%. BRIEF DESCRIPTION OF THE DRAWINGS [0014] FIG. 1 shows a representative saleable units versus treatment at AP2 (stressed location). While not statistically significant, there are nearly 15% increase saleable units obtained from the VT application of AFxRD-038 at AP2. [0015] FIG. 2 shows a representative comparison of Flats versus Rounds within the AP2 location. While not statistically significant, there is a trend toward increased percentage of flat seeds with application of AFxRD-038. [0016] FIG. 3A shows a representative yield comparison of trial locations. Overall yield of AP2 is significantly reduced due to environmental and biotic stresses during the season. AP2 experienced drought and high temperatures, hail damage and subsequent Japanese beetle infestations. Grain yield at AP1 is very respectable for a seed production field and is enhanced through timely irrigation. [0017] FIG. 3B shows a representative yield comparison of treatments across AP1 and AP2 locations. Data combined across locations indicate some overall yield reduction though not statistically significant in plots treated compared to the UTC. [0018] FIG. 3C shows a representative yield comparison between treatments at AP2. Plots treated at the VT timing have increased yield compared to the UTC and the V5 timing although there is no statistical significance. [0019] FIG. 4A shows a representative comparison of Grain Moisture at Harvest between AP1 and AP2. Grain at AP2 has significantly higher moisture at harvest than does grain at AP2. Grain harvest is delayed until October 6 th (about 3 weeks after seed harvest had occurred). Increased moisture is likely the result of poor plant health and stress. [0020] FIG. 4B shows a representative comparison of Grain Moisture between treatments. No difference is observed between treatments for grain moisture. [0021] FIG. 5A shows a representative Test Weight comparison between AP1 and AP2. Test weight of grain from AP1 is significantly less than test weight of grain from AP2. [0022] FIG. 5B shows a representative Test Weight Comparison between treatments across locations. There is no significant difference in test weights related to treatments when summarized across locations. [0023] FIG. 5C shows a representative Test weight Comparison between treatments within locations. While at the AP2 location the VT treatment appears to have slightly lower test weight, since only single samples are analyzed from each location, the significance is unknown. [0024] FIG. 6A shows a representative 1000 (1k) Kernel Weight comparison between Locations. Kernel weights of AP1 are significantly greater than those from AP2. Lower kernel weights are probably the result of the stress conditions at AP2. [0025] FIG. 6B shows a representative 1000 (1k) Kernel Weight Comparison between Treatments. There are no significant differences in kernel weight related to treatments. [0026] FIG. 6C shows a representative 1000 (1k) Kernel Weight Comparison between Treatments within Locations. Since only single samples are analyzed per location, significance is unknown but there appears to be a trend towards lower kernel weights at AP2 with application of AFxRD-038. [0027] FIG. 7A shows a representative 80K Kernel Bag Weight Comparison between Locations. As expected from the test weight and kernel weights, seed from AP2 is significantly lighter than seed from AP1. [0028] FIG. 7B shows a representative 80k Kernel Bag Weight Comparison between Treatments. There is no significant difference in bag weight related to treatments when summarized across locations. [0029] FIG. 7C shows a representative 80k Kernel Bag Weight comparison between treatments within locations. There is no significant difference in bag weight related to treatments. [0030] FIG. 8A shows a representative Seed Size Distribution comparison between locations. While not statistically significant, there is a trend toward larger seeds and more round seeds at the AP1 location. The trend is towards more flat seeds at the AP2 location. [0031] FIG. 8B shows a representative Comparison of Seed Size Distribution as Related to Treatment. While none of the comparisons are statistically significant, there is a trend toward smaller seeds and more flat seeds with applications of AFxRD-038. [0032] FIG. 8C shows a representative Comparison of Flats versus Rounds between treatments across locations. While not statistically significant, there is a trend toward increased percentage of flat seeds with application of AFxRD-038. [0033] FIG. 8D shows a representative Comparison of Flats versus Rounds within the AP2 location. While not statistically significant, there is a trend toward increased percentage of flat seeds with application of AFxRD-038. [0034] FIG. 9A shows a comparison of Warm, Cold and Advanced Aging % Germination Between Treatments (across locations). There appears to be no effect on germination related to treatment. [0035] FIG. 9B shows a comparison of Warm, Cold and Advanced Aging % Germination Between Treatments (within locations). There appears to be no effect on warm or cold germination related to treatment at AP2. However, there is possibly a reduction in AA germination with application of AFxRD-038. Only single samples are analyzed per location, so statistical significance is unknown. Also, all germinations are above the critical 90% level required for seed. [0036] FIG. 10A shows a representative result for Number of saleable units per acre between locations. As expected, there are significantly more saleable units obtained at AP1 (non-stressed) compared to AP2. [0037] FIG. 10B shows a representative result for Saleable Units versus Treatment (across locations). There is no significant difference in saleable units when comparing treatments across locations. [0038] FIG. 10B shows a representative result for Saleable Units versus Treatment at AP2 (stressed location). While not statistically significant, there were nearly 15% increase saleable units obtained from the VT application at AP2. DETAILED DESCRIPTION OF THE INVENTION [0039] The practice of the present invention involves the use of one or more cyclopropenes. As used herein, a cyclopropene compound means any compound with the formula [0000] [0000] where each R 1 , R 2 , R 3 and R 4 is independently selected from the group consisting of H and a chemical group of the formula: [0000] -(L) n -Z [0000] where n is an integer from 0 to 12; each L is independently selected from the group consisting of D1, D2, E, and J; where D1 is of the formula: [0000] [0000] where D2 is of the formula: [0000] [0000] where E is of the formula: [0000] [0000] and where J is of the formula: [0000] [0000] where each X and Y is independently a chemical group of the formula; [0000] -(L) m -Z; [0000] and m is an integer from 0 to 8; and no more than two D2 or E groups are adjacent to each other and no J groups are adjacent to each other; where each Z is independently selected from the group consisting of hydrogen, halo, cyano, nitro, nitroso, azido, chlorate, bromate, iodate, isocyanato, isocyanido, isothiocyanato, pentafluorothio, and a chemical group G, wherein G is a 3 to 14 membered ring system; where the total number of heteroatoms in -(L) n -Z is from 0 to 6; and where the total number of non-hydrogen atoms in the compound is 50 or less. [0040] For the purposes of this invention, in the structural representations of the various L groups, each open bond indicates a bond to another L group, a Z group, or the cyclopropene moiety. For example, the structural representation [0000] [0000] indicates an oxygen atom with bonds to two other atoms; it does not represent a dimethyl ether moiety. [0041] Among embodiments in which at least one of R 1 , R 2 , R 3 , and R 4 is not hydrogen and has more than one L group, the L groups within that particular R 1 , R 2 , R 3 , or R 4 group may be the same as the other L groups within that same R 1 , R 2 , R 3 , or R 4 group, or any other L groups within that same R 1 , R 2 , R 3 , or R 4 group. [0042] Among embodiments in which at least one of R 1 , R 2 , R 3 , and R 4 contains more than one Z group, the Z groups within that R 1 , R 2 , R 3 , or R 4 group may be the same as the other Z groups within that R 1 , R 2 , R 3 , or R 4 group, or any number of Z groups within that R 1 , R 2 , R 3 , or R 4 group may be different from the other Z groups within that R 1 , R 2 , R 3 , or R 4 group. [0043] The R 1 , R 2 , R 3 , and R 4 groups are independently selected from the suitable groups. The R 1 , R 2 , R 3 , and R 4 groups may be the same as each other, or any number of them may be different from the others. Among the groups that are suitable for use as one or more of R 1 , R 2 , R 3 , and R 4 are, for example, aliphatic groups, aliphatic-oxy groups, alkylphosphonato groups, cycloaliphatic groups, cycloalkylsulfonyl groups, cycloalkylamino groups, heterocyclic groups, aryl groups, heteroaryl groups, halogens, silyl groups, other groups, and mixtures and combinations thereof. Groups that are suitable for use as one or more of R 1 , R 2 , R 3 , and R 4 may be substituted or unsubstituted. Independently, groups that are suitable for use as one or more of R 1 , R 2 , R 3 , and R 4 may be connected directly to the cyclopropene ring or may be connected to the cyclopropene ring through an intervening group such as, for example, a heteroatom-containing group. [0044] Among the suitable R 1 , R 2 , R 3 , and R 4 groups are, for example, aliphatic groups. Some suitable aliphatic groups include, for example, alkyl, alkenyl, and alkynyl groups. Suitable aliphatic groups may be substituted or unsubstituted. Some suitable substituted aliphatic groups include, for example, acetylaminoalkenyl, acetylaminoalkyl, acetylaminoalkynyl, alkoxyalkoxyalkyl, alkoxyalkenyl, alkoxyalkyl, alkoxyalkynyl, alkoxycarbonylalkenyl, alkoxycarbonylalkyl, alkoxycarbonylalkynyl, alkylcarbonyloxyalkyl, alkyl(alkoxyimino)alkyl, carboxyalkenyl, carboxyalkyl, carboxyalkynyl, haloalkoxyalkenyl, haloalkoxyalkyl, haloalkoxyalkynyl, haloalkenyl, haloalkyl, haloalkynyl, hydroxyalkenyl, hydroxyalkyl, hydroxyalkynyl, trialkylsilylalkenyl, trialkylsilylalkyl, trialkylsilylalkynyl, dialkylaminoalkyl, alkylsulfonylalkyl, alkylthioalkenyl, alkylthioalkyl, alkylthioalkynyl, haloalkylthioalkenyl, haloalkylthioalkyl, and haloalkylthioalkynyl. [0045] Also among the suitable R 1 , R 2 , R 3 , and R 4 groups are, for example, substituted and unsubstituted aliphatic-oxy groups, such as, for example, alkenoxy, alkoxy, alkynoxy, and alkoxycarbonyloxy. [0046] Also among the suitable R 1 , R 2 , R 3 , and R 4 groups are, for example, substituted and unsubstituted alkylphosphonato, substituted and unsubstituted alkylphosphato, substituted and unsubstituted alkylamino, substituted and unsubstituted alkylsulfonyl, substituted and unsubstituted alkylcarbonyl, and substituted and unsubstituted alkylaminosulfonyl, including, for example, alkylphosphonato, dialkylphosphato, dialkylthiophosphato, dialkylamino, alkylcarbonyl, and dialkylaminosulfonyl. [0047] Among the aliphatic groups suitable as R 1 , R 2 , R 3 , or R 4 are, for example, cycloaliphatic groups, including, for example, cycloalkenyl, cycloalkyl, and cycloalkynyl. Suitable cycloaliphatic groups may be substituted or unsubstituted. Among the suitable substituted cycloaliphatic groups are, for example, acetylaminocycloalkenyl, acetylaminocycloalkyl, acetylaminocycloalkynyl, cycloalkenoxy, cycloalkoxy, cycloalkynoxy, alkoxyalkoxycycloalkyl, alkoxycycloalkenyl, alkoxycycloalkyl, alkoxycycloalkynyl, alkoxycarbonylcycloalkenyl, alkoxycarbonylcycloalkyl, alkoxycarbonylcycloalkynyl, cycloalkylcarbonyl, alkylcarbonyloxycycloalkyl, carboxycycloalkenyl, carboxycycloalkyl, carboxycycloalkynyl, halocycloalkoxycycloalkenyl, halocycloalkoxycycloalkyl, halocycloalkoxycycloalkynyl, halocycloalkenyl, halocycloalkyl, halocycloalkynyl, hydroxycycloalkenyl, hydroxycycloalkyl, hydroxycycloalkynyl, trialkylsilylcycloalkenyl, trialkylsilylcycloalkyl, trialkylsilylcycloalkynyl, dialkylaminocycloalkyl, alkylsulfonylcycloalkyl, cycloalkylcarbonyloxyalkyl, cycloalkylsulfonylalkyl, alkylthiocycloalkenyl, alkylthiocycloalkyl, alkylthiocycloalkynyl, haloalkylthiocycloalkenyl, haloalkylthiocycloalkyl, and haloalkylthiocycloalkynyl. [0048] Also among the suitable R 1 , R 2 , R 3 , and R 4 groups are, for example, substituted and unsubstituted cycloalkylsulfonyl groups and cycloalkylamino groups, such as, for example, dicycloalkylaminosulfonyl and dicycloalkylamino. [0049] Also among the suitable R 1 , R 2 , R 3 , and R 4 groups are, for example, substituted and unsubstituted heterocyclyl groups (i.e., non-aromatic cyclic groups with at least one heteroatom in the ring). Among the suitable substituted heterocyclyl groups are, for example, alkenylheterocyclyl, alkylheterocyclyl, alkynylheterocyclyl, acetylaminoheterocyclyl, alkoxyalkoxyheterocyclyl, alkoxyheterocyclyl, alkoxycarbonylheterocyclyl, alkylcarbonyloxyheterocyclyl, carboxyheterocyclyl, haloalkoxyheterocyclyl, haloheterocyclyl, hydroxyheterocyclyl, trialkylsilylheterocyclyl, dialkylaminoheterocyclyl, alkylsulfonylheterocyclyl, alkylthioheterocyclyl, heterocyclylthioalkyl, and haloalkylthioheterocyclyl. [0050] Also among the suitable R 1 , R 2 , R 3 , and R 4 groups are, for example, substituted and unsubstituted heterocyclyl groups that are connected to the cyclopropene compound through an intervening oxy group, amino group, carbonyl group, or sulfonyl group; examples of such R 1 , R 2 , R 3 , and R 4 groups are heterocyclyloxy, heterocyclylcarbonyl, diheterocyclylamino, and diheterocyclylaminosulfonyl. [0051] Also among the suitable R 1 , R 2 , R 3 , and R 4 groups are, for example, substituted and unsubstituted aryl groups. Some suitable substituted aryl groups are, for example, alkenylaryl, alkylaryl, alkynylaryl, acetylaminoaryl, aryloxy, alkoxyalkoxyaryl, alkoxyaryl, alkoxycarbonylaryl, arylcarbonyl, alkylcarbonyloxyaryl, carboxyaryl, diarylamino, haloalkoxyaryl, haloaryl, hydroxyaryl, trialkylsilylaryl, dialkylaminoaryl, alkylsulfonylaryl, arylsulfonylalkyl, alkylthioaryl, arylthioalkyl, diarylaminosulfonyl, and haloalkylthioaryl. [0052] Also among the suitable R 1 , R 2 , R 3 , and R 4 groups are, for example, substituted and unsubstituted heteroaryl groups. Some suitable substituted heteroaryl groups are, for example, alkenylheteroaryl, alkylheteroaryl, alkynylheteroaryl, acetylaminoheteroaryl, heteroaryloxy, alkoxyalkoxyheteroaryl, alkoxyheteroaryl, alkoxycarbonylheteroaryl, heteroarylcarbonyl, alkylcarbonyloxyheteroaryl, carboxyheteroaryl, diheteroarylamino, haloalkoxyheteroaryl, haloheteroaryl, hydroxyheteroaryl, trialkylsilylheteroaryl, dialkylaminoheteroaryl, alkylsulfonylheteroaryl, heteroarylsulfonylalkyl, alkylthioheteroaryl, and haloalkylthioheteroaryl. [0053] Also among the suitable R 1 , R 2 , R 3 , and R 4 groups are, for example, substituted and unsubstituted heteroaryl groups that are connected to the cyclopropene compound through an intervening oxy group, amino group, carbonyl group, sulfonyl group, thioalkyl group, or aminosulfonyl group; examples of such R 1 , R 2 , R 3 , and R 4 groups are diheteroarylamino, heteroarylthioalkyl, and diheteroarylaminosulfonyl. [0054] Also among the suitable R 1 , R 2 , R 3 , and R 4 groups are, for example, hydrogen, fluoro, chloro, bromo, iodo, cyano, nitro, nitroso, azido, chlorato, bromato, iodato, isocyanato, isocyanido, isothiocyanato, pentafluorothio; acetoxy, carboethoxy, cyanato, nitrato, nitrito, perchlorato, allenyl; butylmercapto, diethylphosphonato, dimethylphenylsilyl, isoquinolyl, mercapto, naphthyl, phenoxy, phenyl, piperidino, pyridyl, quinolyl, triethylsilyl, trimethylsilyl; and substituted analogs thereof. [0055] As used herein, the chemical group G is a 3 to 14 membered ring system. Ring systems suitable as chemical group G may be substituted or unsubstituted; they may be aromatic (including, for example, phenyl and napthyl) or aliphatic (including unsaturated aliphatic, partially saturated aliphatic, or saturated aliphatic); and they may be carbocyclic or heterocyclic. Among heterocyclic G groups, some suitable heteroatoms are, for example, nitrogen, sulfur, oxygen, and combinations thereof. Ring sysytems suitable as chemical group G may be monocyclic, bicyclic, tricyclic, polycyclic, or fused; among suitable chemical group G ring systems that are bicyclic, tricyclic, or fused, the various rings in a single chemical group G may be all the same type or may be of two or more types (for example, an aromatic ring may be fused with an aliphatic ring). [0056] In some embodiments, G is a ring system that contains a saturated or unsaturated 3 membered ring, such as, for example, a substituted or unsubstituted cyclopropane, cyclopropene, epoxide, or aziridine ring. [0057] In some embodiments, G is a ring system that contains a 4 membered heterocyclic ring; in some of such embodiments, the heterocyclic ring contains exactly one heteroatom. Independently, in some embodiments, G is a ring system that contains a heterocyclic ring with 5 or more members; in some of such embodiments, the heterocyclic ring contains 1 to 4 heteroatoms. Independently, in some embodiments, the ring in G is unsubstituted; in other embodiments, the ring system contains 1 to 5 substituents; in some of the embodiments in which G contains substituents, each substituent is independently chosen from chemical groups in the category X as defined herein below. Also suitable are embodiments in which G is a carbocyclic ring system. [0058] Among the suitable G groups are, for example, cyclopropyl, cyclobutyl, cyclopent-3-en-1-yl, 3-methoxycyclohexan-1-yl, phenyl, 4-chlorophenyl, 4-fluorophenyl, 4-bromophenyl, 3-nitrophenyl, 2-methoxyphenyl, 2-methylphenyl, 3-methyphenyl, 4-methylphenyl, 4-ethylphenyl, 2-methyl-3-methoxyphenyl, 2,4-dibromophenyl, 3,5-difluorophenyl, 3,5-dimethylphenyl, 2,4,6-trichlorophenyl, 4-methoxyphenyl, naphthyl, 2-chloronaphthyl, 2,4-dimethoxyphenyl, 4-(trifluoromethyl)phenyl, 2-iodo-4-methylphenyl, pyridin-2-yl, pyridin-3-yl, pyridin-4-yl, pyrazinyl, pyrimidin-2-yl, pyrimidin-4-yl, pyrimidin-5-yl, pyridazinyl, triazol-1-yl, imidazol-1-yl, thiophen-2-yl, thiophen-3-yl, furan-2-yl, furan-3-yl, pyrrolyl, oxazolyl, isoxazolyl, thiazolyl, isothiazolyl, oxadiazolyl, thiadiazolyl, quinolyl, isoquinolyl, tetrahydrofuryl, pyrrolidinyl, piperidinyl, tetrahydropyranyl, morpholinyl, piperazinyl, dioxolanyl, dioxanyl, indolinyl and 5-methyl-6-chromanyl, adamantyl, norbornyl, and their substituted analogs such as, for example: 3-butyl-pyridin-2-yl, 4-bromo-pyridin-2-yl, 5-carboethoxy-pyridin-2-yl, and 6-methoxyethoxy-pyridin-2-yl. [0059] In some embodiments, each G is independently a substituted or unsubstituted phenyl, pyridyl, cyclohexyl, cyclopentyl, cycloheptyl, pyrolyl, furyl, thiophenyl, triazolyl, pyrazolyl, 1,3-dioxolanyl, or morpholinyl. Among these embodiments include those embodiments, for example, in which G is unsubstituted or substituted phenyl, cyclopentyl, cycloheptyl, or cyclohexyl. In some of these embodiments, G is cyclopentyl, cycloheptyl, cyclohexyl, phenyl, or substituted phenyl. Among embodiments in which G is substituted phenyl are embodiments, for example, in which there are 1, 2, or 3 substituents. Independently, also among embodiments in which G is substituted phenyl are embodiments, for example, in which the substituents are independently selected from methyl, methoxy, and halo. [0060] In some embodiments, one or more cyclopropenes are used in which one or more of R 1 , R 2 , R 3 , and R 4 is hydrogen. In some embodiments, R 1 or R 2 or both R 1 and R 2 is hydrogen. Independently, in some embodiments, R 3 or R 4 or both R 3 and R 4 is hydrogen. In some embodiments, R 2 , R 3 , and R 4 are hydrogen. [0061] In some embodiments, one or more of R 1 , R 2 , R 3 , and R 4 is a structure that has no double bond. Independently, in some embodiments, one or more of R 1 , R 2 , R 3 , and R 4 is a structure that has no triple bond. Independently, in some embodiments, one or more of R 1 , R 2 , R 3 , and R 4 is a structure that has no halogen atom substituent. Independently, in some embodiments, one or more of R 1 , R 2 , R 3 , and R 4 is a structure that has no substituent that is ionic. Independently, in some embodiments, one or more of R 1 , R 2 , R 3 , and R 4 is a structure that is not capable of generating oxygen compounds. [0062] In some embodiments of the invention, one or more of R 1 , R 2 , R 3 , and R 4 is hydrogen or (C 1 -C 10 ) alkyl. In some embodiments, each of R 1 , R 2 , R 3 , and R 4 is hydrogen or (C 1 -C 8 ) alkyl. In some embodiments, each of R 1 , R 2 , R 3 , and R 4 is hydrogen or (C 1 -C 4 ) alkyl. In some embodiments, each of R 1 , R 2 , R 3 , and R 4 is hydrogen or methyl. When R 1 is methyl and each of R 2 , R 3 , and R 4 is hydrogen, the cyclopropene is known herein as “1-MCP.” [0063] In some embodiments, a cyclopropene is used that has boiling point at one atmosphere pressure of 50° C. or lower; or 25° C. or lower; or 15° C. or lower. Independently, in some embodiments, a cyclopropene is used that has boiling point at one atmosphere pressure of −100° C. or higher; −50° C. or higher; or −25° C. or higher; or 0° C. or higher. [0064] The cyclopropenes applicable to this invention may be prepared by any method. Some suitable methods of preparation of cyclopropenes are the processes disclosed in U.S. Pat. Nos. 5,518,988 and 6,017,849. Any compound that is not a cyclopropene is known herein as a “non-cyclopropene.” [0065] In some embodiments, one or more composition of the present invention includes at least one ionic complexing reagent. An ionic complexing reagent interacts with a cyclopropene to form a complex that is stable in water. Some suitable ionic complexing reagents, for example, include lithium ion. In some embodiments, no ionic complexing reagent is used. [0066] In some embodiments, no composition of the present invention includes any molecular encapsulating agent. In other embodiments, one or more composition of the present invention includes at least one molecular encapsulating agent. [0067] When a molecular encapsulating agent is used, suitable molecular encapsulating agents include, for example, organic and inorganic molecular encapsulating agents. Suitable organic molecular encapsulating agents include, for example, substituted cyclodextrins, unsubstituted cyclodextrins, and crown ethers. Suitable inorganic molecular encapsulating agents include, for example, zeolites. Mixtures of suitable molecular encapsulating agents are also suitable. In some embodiments of the invention, the encapsulating agent is alpha-cyclodextrin, beta-cyclodextrin, gamma-cyclodextrin, or a mixture thereof. In some embodiments of the invention, particularly when the cyclopropene is 1-methylcyclopropene, the encapsulating agent is alpha-cyclodextrin. The preferred encapsulating agent will vary depending upon the structure of the cyclopropene or cyclopropenes being used. Any cyclodextrin or mixture of cyclodextrins, cyclodextrin polymers, modified cyclodextrins, or mixtures thereof can also be utilized pursuant to the present invention. Some cyclodextrins are available, for example, from Wacker Biochem Inc., Adrian, Mich. or Cerestar USA, Hammond, Ind., as well as other vendors. [0068] In some of the embodiments in which a molecular encapsulating agent is present, at least one molecular encapsulating agent encapsulates one or more cyclopropenes. A cyclopropene or substituted cyclopropene molecule encapsulated in a molecule of a molecular encapsulating agent is known herein as a “cyclopropene molecular encapsulating agent complex.” The cyclopropene molecular encapsulation agent complexes can be prepared by any means. In one method of preparation, for example, such complexes are prepared by contacting the cyclopropene with a solution or slurry of the molecular encapsulation agent and then isolating the complex, using, for example, processes disclosed in U.S. Pat. No. 6,017,849. For example, in one method of making a complex in which 1-MCP is encapsulated in a molecular encapsulating agent, the 1-MCP gas is bubbled through a solution of alpha-cyclodextrin in water, from which the complex first precipitates and is then isolated by filtration. In some embodiments, complexes are made by the above method and, after isolation, are dried and stored in solid form, for example as a powder, for later addition to useful compositions. [0069] In some embodiments, one or more molecular encapsulating agent and one or more cyclopropenes are both present in a composition; in some of such embodiments, the amount of molecular encapsulating agent can usefully be characterized by the ratio of moles of molecular encapsulating agent to moles of cyclopropene. In some embodiments, the ratio of moles of molecular encapsulating agent to moles of cyclopropene is 0.1 or larger; or 0.2 or larger; or 0.5 or larger; or 0.9 or larger. Independently, in some of such embodiments, the ratio of moles of molecular encapsulating agent to moles of cyclopropene is 2 or lower; or 1.5 or lower. [0070] In some embodiments, the composition of the present invention has no abscission agent. [0071] In the practice of the present invention, the composition may be contacted with a plant in a variety of ways. For example, the composition of the present invention may be a solid, a liquid, a gas, or a mixture thereof. [0072] In some embodiments, a plant is contacted with at least one composition of the present invention that is a gas. Among such embodiments, it is contemplated that the plant being treated will be surrounded by a normal ambient atmosphere (at approximately 1 atmosphere pressure) to which composition of the present invention has been added. In some embodiments, the concentration of cyclopropene is 0.1 nl/l (i.e., nanoliter per liter) or higher; or 1 nl/l or higher, or 10 nl/l or higher; or 100 nl/l or higher. Independently, in some embodiments, the concentration of cyclopropene is 3,000 nl/l or lower; or 1,000 nl/l or lower. [0073] In some embodiments, the practice of the present invention involves one or more liquid compositions. In some embodiments, liquid compositions are liquid at 25° C. In some embodiments, liquid compositions are liquid at the temperature at which the composition is used to treat plants. Because plants are often treated outside of any buildings, plants may be treated at temperatures ranging from 1° C. to 45° C.; suitable liquid compositions need not be liquid over that entire range, but suitable liquid compositions are liquid at some temperature from 1° C. to 45° C. [0074] A liquid composition of the present invention may be a single pure substance, or it may contain more than one substance. If a liquid composition contains more than one substance, that liquid composition may be a solution or a dispersion or a combination thereof. If, in the liquid composition, one substance is dispersed in another substance in the form of a dispersion, the dispersion may be of any type, including, for example, a suspension, a latex, an emulsion, a miniemulsion, a microemulsion, or any combination thereof. [0075] Among embodiments in which the composition of the present invention is a liquid, the amount of cyclopropene in the composition may vary widely, depending on the type of composition and the intended method of use. In some embodiments, the amount of cyclopropene, based on the total weight of the composition, is 4% by weight or less; or 1% by weight or less; or 0.5% by weight or less; or 0.05% by weight or less. Independently, in some embodiments, the amount of cyclopropene, based on the total weight of the composition, is 0.000001% by weight or more; or 0.00001% by weight or more; or 0.0001% by weight or more; or 0.001% by weight or more. [0076] Among embodiments of the present invention that use a composition of the present invention that contains water, the amount of cyclopropene may be characterized as parts per million (i.e., parts by weight of cyclopropene per 1,000,000 parts by weight of water in the composition, “ppm”) or as parts per billion (i.e., parts by weight of cyclopropene per 1,000,000,000 parts by weight of water in the composition, “ppb”). In some embodiments, the amount of cyclopropene is 1 ppb or more; or 10 ppb or more; or 100 ppb or more. Independently, in some embodiments, the amount of cyclopropene is 10,000 ppm or less; or 1,000 ppm or less. [0077] In some embodiments, a composition of the present invention that is a liquid is used in which some or all of the cyclopropene is encapsulated in one or more encapsulating agent. [0078] In some embodiments, no composition of the present invention includes one or more metal-complexing agents. In some embodiments, one or more compositions of the present invention include one or more metal-complexing agents. [0079] Among embodiments in which one or more liquid compositions are used, in some of such embodiments, one or more metal-complexing agents may be included in one or more liquid compositions. A metal-complexing agent is a compound that is capable of forming coordinate bonds with metal atoms. Some metal-complexing agents are chelating agents. As used herein, a “chelating agent” is a compound, each molecule of which is capable of forming two or more coordinate bonds with a single metal atom. Some metal-complexing agents form coordinate bonds with metal atoms because the metal-complexing agents contain electron-donor atoms that participate in coordinate bonds with metal atoms. Suitable chelating agents include, for example, organic and inorganic chelating agents. Among the suitable inorganic chelating agents are, for example, phosphates such as, for example, tetrasodium pyrophosphate, sodium tripolyphosphate, and hexametaphosphoric acid. Among the suitable organic chelating agents are those with macrocyclic structures and non-macrocyclic structures. Among the suitable macrocyclic organic chelating agents are, for example, porphine compounds, cyclic polyethers (also called crown ethers), and macrocyclic compounds with both nitrogen and oxygen atoms. [0080] Some suitable organic chelating agents that have non-macrocyclic structures are, for example, aminocarboxylic acids, 1,3-diketones, hydroxycarboxylic acids, polyamines, aminoalcohols, aromatic heterocyclic bases, phenol, aminophenols, oximes, Shiff bases, sulfur compounds, and mixtures thereof. In some embodiments, the chelating agent includes one or more aminocarboxylic acids, one or more hydroxycarboxylic acids, one or more oximes, or a mixture thereof. Some suitable aminocarboxylic acids include, for example, ethylenediaminetetraacetic acid (EDTA), hydroxyethylethylenediaminetriacetic acid (HEDTA), nitrilotriacetic acid (NTA), N-dihydroxyethylglycine (2-HxG), ethylenebis(hydroxyphenylglycine) (EHPG), and mixtures thereof. Some suitable hydroxycarboxylic acids include, for example, tartaric acid, citric acid, gluconic acid, 5-sulfoslicylic acid, and mixtures thereof. Some suitable oximes include, for example, dimethylglyoxime, salicylaldoxime, and mixtures thereof. In some embodiments, EDTA is used. [0081] Some additional suitable chelating agents are polymeric. Some suitable polymeric chelating agents include, for example, polyethyleneimines, polymethacryloylacetones, poly(acrylic acid), and poly(methacrylic acid). Poly(acrylic acid) is used in some embodiments. [0082] Some suitable metal-complexing agents that are not chelating agents are, for example, alkaline carbonates, such as, for example, sodium carbonate. [0083] Metal-complexing agents may be present in neutral form or in the form of one or more salts. Mixtures of suitable metal-complexing agents are also suitable. [0084] In some embodiments of the present invention, the compositions of the present invention do not contain water. In other embodiments, the compositions of the present invention contain water; in some of such embodiments, the water contains one or more metal ions, such as, for example, iron ions, copper ions, other metal ions, or mixtures thereof. In some embodiments, the water contains 0.1 ppm or more of one or more metal ions. [0085] Among embodiments that use one or more metal-complexing agents, the amount of metal-complexing agent used may vary widely. In some embodiments in which at least one liquid composition is used, the amount of metal-complexing agent in that liquid composition will be adjusted to be sufficient to complex the amount of metal ion that is present or expected to be present in the liquid composition that contains the metal-complexing agent. For example, in some embodiments in which a liquid composition of the present invention is used that includes water that contains some metal ion, if a relatively efficient metal-complexing agent is used (i.e., a metal-complexing agent that will form a complex with all or nearly all the metal ions in the water), the ratio of moles of metal-complexing agent to moles of metal ion will be 0.1 or greater; or 0.2 or greater; or 0.5 or greater; or 0.8 or greater. Among such embodiments that use a relatively efficient metal-complexing agent, the ratio of moles of metal-complexing agent to moles of metal ion will be 2 or less; or 1.5 or less; or 1.1 or less. It is contemplated that, if a less-efficient metal-complexing agent is used, the ratio of moles of metal-complexing agent to moles of metal ion could be increased to compensate for the lower efficiency. [0086] Independently, in some embodiments in which a liquid composition is used, the amount of metal-complexing agent is, based on the total weight of the liquid composition, 25% by weight or less; or 10% by weight or less; or 1% by weight or less. Independently, in some embodiments, the amount of metal-complexing agent is, based on the total weight of the liquid composition, 0.00001% or more; or 0.0001% or more; or 0.01% or more. [0087] Independently, in some embodiments in which a liquid composition that includes water is used, the amount of metal-complexing agent can usefully be characterized by the molar concentration of metal-complexing agent in the water (i.e., moles of metal-complexing agent per liter of water). In some of such liquid compositions, the concentration of metal-complexing agent is 0.00001 mM (i.e., milli-Molar) or greater; or 0.0001 mM or greater; or 0.001 mM or greater; or 0.01 mM or greater; or 0.1 mM or greater. Independently, in some embodiments in which a liquid composition of the present invention includes water, the concentration of metal-complexing agent is 100 mM or less; or 10 mM or less; or 1 mM or less. [0088] In some embodiments of the present invention, one or more adjuvants is also included in the composition of the present invention. The use of adjuvants is considered optional in the practice of the present invention. Adjuvants may be used alone or in any combination. When more than one adjuvant is used, it is contemplated that any combination of one or more adjuvants may be used. Some suitable adjuvants are surfactants, alcohols, oils, extenders, pigments, fillers, binders, plasticizers, lubricants, wetting agents, spreading agents, dispersing agents, stickers, adhesives, defoamers, thickeners, transport agents, and emulsifying agents. [0089] In some embodiments, a composition of the present invention is used that contains at least one adjuvant selected from alcohols, oils, and mixtures thereof; such a composition may or may not additionally contain one or more surfactant. [0090] Among embodiments in which one or more liquid compositions are used, various embodiments are contemplated that include the use of, for example, any one or more of the following liquid compositions: liquid compositions that contain one or more surfactant but no oil and no alcohol; liquid compositions that contain one or more oil but no surfactant and no alcohol; and liquid compositions that contain one or more alcohol but no surfactant and no oil. In some embodiments, one or more liquid compositions are used that each contain one or more surfactant and one or more oil; or one or more liquid compositions are used that each contain one or more surfactant and one or more alcohol. In some embodiments, one or more liquid compositions are used that each contains one or more surfactant, one or more oil, and one or more alcohol. [0091] Among embodiments in which one or more liquid compositions are used, in some liquid compositions, one or more alcohols are used. Suitable alcohols include, for example, alkyl alcohols and other alcohols. As used herein, alkyl alcohols are alkyl compounds with one hydroxyl group; the alkyl group may be linear, branched, cyclic, or a combination thereof; the alcohol may be primary, secondary, or tertiary. In some embodiments, alkyl alcohols are used which have alkyl groups with 2 or more carbon atoms. In some embodiments, ethanol, isopropanol, or a mixture thereof is used. In some embodiments, one or more alkyl alcohols are used which have alkyl groups with 20 or fewer carbon atoms; or 10 or fewer carbon atoms; or 6 or fewer carbon atoms; or 3 or fewer carbon atoms. [0092] Among liquid compositions that use alcohol, some liquid compositions use alcohol in amounts, by weight based on the total weight of the liquid composition, of 0.25% or higher; or 0.5% or higher; or 1% or higher. Among liquid compositions that use alcohol, some liquid compositions use alcohol in amounts, by weight based on the total weight of the liquid composition, of 90% or less; or 50% or less; or 10% or less; or 5% or less; or 4% or less; or 3% or less. [0093] As used herein, the phrase “plant” includes dicotyledons plants and monocotyledons plants. Some plants are grown for the purpose of removing one or more plant parts, when such parts are considered a useful product. Such plants are known herein as “crop plants.” Removal of such useful plant parts is known as harvesting. In the practice of the present invention, plants that produce useful plant parts are treated with composition of the present invention prior to the harvesting of the useful plant parts. In such embodiments, each composition that is used may, independently of any other compositions that may be used, be brought into contact with all of or with some portion of the plant. If a composition is brought into contact with a portion of the plant, that portion may or may not include the useful plant part intended to be harvested. [0094] In the practice of the present invention, at least one treatment is performed on crop plants before any useful plant parts are harvested. The growth and development process of many crop plants can be described by certain developmental stages. For example, many crop plants develop through vegetative stages followed by reproductive stages. In some embodiments, crop plants are contacted with a composition of the present invention one or more times during one or more vegetative stages. Independently, in some embodiments, crop plants are contacted with a composition of the present invention one or more times during one or more reproductive stages. Also contemplated are embodiments in which crop plants are contacted with a composition of the present invention one or more times during one or more vegetative stages and also contacted with a composition of the present invention one or more times during one or more reproductive stages. Some crop plants develop through ripening stages after their reproductive stages; it is contemplated in some embodiments to contact such crop plants with one or more composition of the present invention one or more times during one or more ripening stage, either in addition to or instead of contact with one or more composition of the present invention during other stage or stages. In some embodiments, the plants or crop plants of the present invention include seed corn and inbred corn production. [0095] Some crop plants develop through vegetative and reproductive processes simultaneously. It is contemplated to contact such crop plants with one or more composition of the present invention one or more times after germination but before harvest. [0096] It is contemplated that, for some specific crop plants, there may be an optimum stage or stages at which to perform the contact with the composition of the present invention, in order to achieve the maximum improvement in crop yield. It is contemplated that such optimum stage or stages may be different for each type of crop plant, and such optimum stage or stages may, in some cases, depend on the specific growing conditions. [0097] In some embodiments, it is contemplated to contact a group of crop plants at a certain desired stage of development. In such cases, it is contemplated that such contacting may be performed when the ratio of the number of plants that have reached the desired stage of development to the total number of plants in the group is at least 0.1, or at least 0.5, or at least 0.75, or at least 0.9 (i.e., when the portion of plants that have reached the desired stage of development is at least 10%, or 50%, or 75%, or 90%). [0098] For example, corn plants also develop through vegetative stages followed by reproductive stages. The vegetative growth stages of corn plants include VE (emergence), V1 (emergence of first leaf), VN (emergence of Nth leaf), VNMAX (emergence of last leaf), and VT (tasselling). One of these vegetative stages is V5, which begins when the fifth leaf emerges. Another of these vegetative stages is V12, which begins when the twelfth leaf emerges. The reproductive growth stages of corn plants include R1 (silking), R2 (blister), R3 (milk), R4 (dough), R5 (dent), R6 (maturity). In some embodiments, corn plants are contacted with one or more composition of the present invention during or after any of V5 (emergence of fifth leaf), V12 (emergence of 12th leaf), VT, R3, or during or after any combination of two or more of V6, V12, VT, and R3. Independently, in some embodiments, corn plants are contacted with one or more composition of the present invention during V12, during VT, and during R3. Independently, some embodiments involve spraying corn plants one or more times with at least one liquid composition comprising at least one cyclopropene, after at least 10% of said corn plants have reached the developmental stage at which the fifth leaf is fully expanded, or after at least 10% of said corn plants have reached the developmental stage at which the twelfth leaf is fully expanded. [0099] Suitable treatments may be performed on plants that are planted in a field, in a garden, in a building (such as, for example, a greenhouse), or in another location. Suitable treatments may be performed on a plants that are planted in open ground, in one or more containers (such as, for example, a pot, planter, or vase), in confined or raised beds, or in other places. [0100] In some embodiments, treatment is performed on plants that are in a location other than in a building. [0101] In some embodiments, plants are treated while they are growing in a container such as, for example, pots, flats, or portable beds. In some of such cases, when treated plants are subsequently transplanted to open ground, the treated plants resist the stress of transplantation better than untreated plants do. In some embodiments, such resistance to transplantation stress can lead to improved crop yield. For example, tomatoes that are treated according to the practice of the present invention and that are transplanted can sometimes show improved resistance to transplantation stress and, sometimes, improved crop yield, in comparison to untreated tomato plants. [0102] In some embodiments, the amount of cyclopropene is chosen to be appropriate for the particular crop that is being treated. For example, in some of the embodiments in which the crop plants are corn or soybean, the amount of cyclopropene is 500 g/ha or less; or 250 g/ha or less; or 100 g/ha or less, or 50 g/ha or less. For another example, in some of the embodiments in which the crop plants are cotton, the amount of cyclopropene is 50 g/ha or more; or 100 g/ha or more; or 200 g/ha or more. [0103] In some embodiments of the present invention, a group of plants is treated simultaneously or sequentially. One characteristic of such a group of plants is the crop yield, which is defined as the amount (herein called “crop amount”) of useful plant parts collected from a defined group of plants. In one useful definition of the crop yield, the defined group of plants is the group that occupies a certain area of ground (this definition is often used when plants are growing in a contiguous group in a field). In another useful definition of the crop yield, the defined group of plants is a specific number of individually identified plants (this definition may be used for any group of plants, including, for example, plants in fields, in pots, in greenhouses, or any combination thereof). [0104] The crop amount may be defined in a variety of ways. In the practice of the present invention, the crop amount may be measured, for example, by any of the following methods: weight, volume, number of harvested plant parts, or biomass. Also contemplated are methods in which the crop amount is measured as the amount in the crop of a specific constituent (such as, for example, sugar, starch, or protein). Further contemplated are methods in which the crop amount is measured as the amount of a certain characteristic (such as, for example, redness, which is sometimes used to measure the amount of a crop of tomatoes). Additionally contemplated are methods in which the crop amount is measured as the amount of a specific portion of the harvested plant part (such as, for example, the number of kernels or the weight of kernels, which are sometimes used to measure the amount of a crop of corn; or the weight of lint, which is sometimes used to measure the amount of a cotton crop). [0105] In some embodiments, the crop yield is defined as the crop amount per unit of area of land. That is, the land area from which the crop was harvested is measured, and the crop amount is divided by the land area to calculate the crop yield. For example, a crop amount measured as the weight of harvested plant parts would lead to a crop yield that is reported as a weight per area (for example, kilograms per hectare). [0106] It is contemplated that, in some embodiments, the harvested plant parts that contribute to the crop amount are those plant parts that meet the minimum quality criteria that are appropriate for that type of plant part. That is, when plant parts are harvested from certain plants, the crop amount is, for example, the weight of the plant parts of acceptable quality that are harvested from those plants. Acceptable quality may be determined by any of the common criteria used by persons who harvest or handle the plant part of interest. Such criteria of acceptable quality of a plant part may be, for example, one or more of size, weight, firmness, resistance to bruising, flavor, sugar/starch balance, color, beauty, other quality criteria, or any combination thereof. Also contemplated as a criterion of quality, either alone or in combination with any of the foregoing criteria, is the time over which the plant part maintains its quality (as judged by any of the forgoing criteria). [0107] In some embodiments of the present invention, treatment of a group of plants with the methods of the present invention will increase the crop yield of that group of plants, compared to the crop yield that would have been obtained from that group of plants if it had not been treated with the methods of the present invention. The increase in crop yield may be obtained in any of a wide variety of ways. For example, one way an increase in crop yield may be obtained is that each plant may produce a greater number of useful plant parts. As another example, one way an increase in crop yield may be obtained is that each useful plant part may have higher weight. As a third example, crop yield may increase when a larger number of potentially useful plant parts meet the minimum criteria for acceptable quality. Other ways of increasing the crop yield may also result from the practice of the present invention. Also contemplated are increases in crop yield that happen by any combination of ways. [0108] Another contemplated benefit of practicing some embodiments of the present invention is that the general quality of the crop may be improved. That is, a crop produced by methods of the present invention may have a general or average level of quality higher than comparable crops produced without the methods of the present invention, as judged by the quality criteria appropriate for that crop. In some cases, such higher-quality crops may command higher prices when sold. [0109] The improvement in crop yield caused by the practice of the present invention may arise by any mechanism. That is, the practice of the present invention, in some embodiments, may cause an improvement in some process of the plant's development, maturation, growth, or reproduction, and such improvement in such process may, in turn, cause improvement in crop yield. For example, the practice of the present invention may cause an improvement in any one or any combination of the following processes: synchronization of pollination (i.e., better agreement between the time period when a plant sheds pollen and the time period when that plant is able to receive the pollen and become fertilized), photosynthesis, nitrogen accumulation, leaf senescence, or late-season production of green leaves. In some of the embodiments where photosynthesis is improved, the improvement in photosynthesis can be observed as increased assimilation of carbon dioxide. Independently, the improvement in crop yield may, in some embodiments, occur because of improvement in disease resistance or drought resistance or frost resistance or heat resistance or a combination thereof. [0110] In some crops (such as, for example, corn), it is contemplated that drought resistance and the resultant improvement in crop yield arise because the practice of the present invention causes stomatal closure, which gives the plant its resistance to drought. Independently, some crops (such as, for example, wheat) experience improved frost tolerance when used in the practice of the present invention. Independently, some crops (such as, for example, wheat and grapes) experience improved resistance to disease when used in the practice of the present invention. [0111] In some embodiments, improvement in crop yield may occur because of a delay in the dropping of one or more of leaves, flowers, or fruiting structures (such as, for example, pods, bolls, or the fruit itself). In some embodiments, improvement in crop yield may occur because of enhanced root nodulation, which sometimes occurs in certain crops such as, for example, soybeans. [0112] Whether or not the practice of the present invention results in improvement in one or more of the above-mentioned processes, in some embodiments the practice of the present invention leads to improvement in one or more of the following: biomass volume, biomass quality, increased fruit, increased fruit size (when desired), decreased fruit size (when desired), harvest timing (advanced or delayed, as desired), reduced fruit drop, decreased cell turgor, decreased russetting, lowered stress response, lowered wounding response, reduced storage disorders in harvested plant parts, increased shelf life of harvested plant parts, apical dominance, abscission prevention, senescence prevention, yellowing prevention, improved vigor during growth, improved vigor during transit, improved vigor during transplant, and combinations thereof. [0113] In some embodiments, an improvement in crop yield is evident at the time of harvest, such as, for example, when the improvement is an increase in weight of crop per unit area of land. In some embodiments, an improvement in crop yield is observed some time after the crop has been in storage. That is, in some cases, the crop yield is measured as the amount of high-quality crop that is delivered to the retail market after storage. It is contemplated that some embodiments of the present invention involve pre-harvest contacting of crop plants resulting in crop that can be put in storage after harvest and then come out of storage with higher quality than previously obtainable. EXAMPLES Example 1 [0114] A representative saleable units versus treatment at AP2 (stressed location) is shown in FIG. 1 . While not statistically significant, there are nearly 15% increase saleable units obtained from the VT application of AFxRD-038 at AP2. [0115] A representative comparison of Flats versus Rounds within the AP2 location is shown in FIG. 2 . While not statistically significant, there is a trend toward increased percentage of flat seeds with application of AFxRD-038. [0116] There are no visible phytotoxic effects observed from the applications of AFxRD-038 in any of the plots. [0117] There are significant differences in almost all of the seed traits due to location but no statistically significant differences related to treatment. The more stressed location, AP2, resulted in lower yield and fewer, smaller and flatter seeds with slightly lower germination. [0118] There are trends towards more flat seeds and more saleable units of seed produced per acre (˜15%) with the VT application of AFxRD-038 at the AP2 location. The increase in saleable units appears to be a result of more flats and fewer large round seeds. Example 2 [0119] A similar experiment showing effects of AFxRD-038 in hybrid seed corn product is conducted and results are summarized in FIGS. 3-10 . The Objective of this study is to determine whether applications of AFxRD-038 have a positive effect on seed yield of hybrid seed production. [0120] Treatments with AFxRD-038 in hybrid seed production indicate that there is potential for increased value with little risk of phytotoxic or detrimental effects. Increased value seems to be possible from increased seeds per acre under stressed production conditions. Treatments used are the following: [0121] (1) AFxRD-038 @ 25 gm/ha, V5 [0122] (2) AFxRD-038 @ 25 gm/ha, VT (just prior to detasseling) [0123] (3) UTC [0124] 2 Replications, Plots 15 ft (4 rows female+2 rows male)×50 feet long [0125] Observations include the following parameters: Phytotoxicity, Chlorosis, Necrosis, Plant Height Reduction, Date of Anthesis & Silking versus UTC, Leaf Senescence, % Barren stalks, Yield, % Moisture, # Kernel Rows, Test Weight, 1000 Seed Weight, Seed Size Distribution, and Germination (warm, cold and advanced aging). [0126] Locations include (1) AP1: Essentially non-stressed, irrigated; and (2) AP2: Highly stressed non-irrigated. [0127] No negative effects of product application are observed in any of the treatments at either location. No differences in flowering characteristics are observed (date of pollination, date of silking), and no differences in crop maturation are observed. [0128] Yield: A representative yield comparison of trial locations is shown in FIG. 3A . Overall yield of AP2 is significantly reduced due to environmental and biotic stresses during the season. AP2 experienced drought and high temperatures, hail damage and subsequent Japanese beetle infestations. Grain yield at AP1 is very respectable for a seed production field and is enhanced through timely irrigation. A representative yield comparison of treatments across AP1 and AP2 locations is shown in FIG. 3B . Data combined across locations indicate some overall yield reduction though not statistically significant in plots treated compared to the UTC. A representative yield comparison between treatments at AP2 is shown in FIG. 3C . Plots treated at the VT timing have increased yield compared to the UTC and the V5 timing although there is no statistical significance. [0129] Grain Moisture at Harvest: A representative comparison of Grain Moisture at Harvest between AP1 and AP2 is shown in FIG. 4A . Grain at AP2 has significantly higher moisture at harvest than does grain at AP2. Grain harvest is delayed until October 6 th (about 3 weeks after seed harvest had occurred). Increased moisture is likely the result of poor plant health and stress. A representative comparison of Grain Moisture between treatments is shown in FIG. 4B . No difference is observed between treatments for grain moisture. [0130] Test Weight and Kernel Weight: A representative Test Weight comparison between AP1 and AP2 is shown in FIG. 5A . Test weight of grain from AP1 is significantly less than test weight of grain from AP2. A representative Test Weight Comparison between treatments across locations is shown in FIG. 5B . There is no significant difference in test weights related to treatments when summarized across locations. A representative Test weight Comparison between treatments within locations is shown in FIG. 5C . While at the AP2 location the VT treatment appears to have slightly lower test weight, since only single samples are analyzed from each location, the significance is unknown. [0131] 1000 (1k) Kernel Weight: A representative 1000 (1k) Kernel Weight comparison between Locations is shown in FIG. 6A . Kernel weights of AP1 are significantly greater than those from AP2. Lower kernel weights are probably the result of the stress conditions at AP2. A representative 1000 (1k) Kernel Weight Comparison between Treatments is shown in FIG. 6B . There are no significant differences in kernel weight related to treatments. A a representative 1000 (1k) Kernel Weight Comparison between Treatments within Locations is shown in FIG. 6C . Since only single samples are analyzed per location, significance is unknown but there appears to be a trend towards lower kernel weights at AP2 with application of AFxRD-038. [0132] Weight of 80k Kernel Bag: A representative 80K Kernel Bag Weight Comparison between Locations is shown in FIG. 7A . As expected from the test weight and kernel weights, seed from AP2 is significantly lighter than seed from AP1. A representative 80k Kernel Bag Weight Comparison between Treatments is shown in FIG. 7B . There is no significant difference in bag weight related to treatments when summarized across locations. A representative 80k Kernel Bag Weight comparison between treatments within locations is shown in FIG. 7C . There is no significant difference in bag weight related to treatments. [0133] Seed Size Distribution: A representative Seed Size Distribution comparison between locations is shown in FIG. 8A . While not statistically significant, there is a trend toward larger seeds and more round seeds at the AP1 location. The trend is towards more flat seeds at the AP2 location. A representative Comparison of Seed Size Distribution as Related to Treatment is shown in FIG. 8B . While none of the comparisons are statistically significant, there is a trend toward smaller seeds and more flat seeds with applications of AFxRD-038. A representative Comparison of Flats versus Rounds between treatments across locations is shown in FIG. 8C . While not statistically significant, there is a trend toward increased percentage of flat seeds with application of AFxRD-038. A representative Comparison of Flats versus Rounds within the AP2 location is shown in FIG. 8D . While not statistically significant, there is a trend toward increased percentage of flat seeds with application of AFxRD-038. [0134] Germination: A comparison of Warm, Cold and Advanced Aging % Germination Between Treatments (across locations) is shown in FIG. 9A . There appears to be no effect on germination related to treatment. A comparison of Warm, Cold and Advanced Aging % Germination Between Treatments (within locations) is shown in FIG. 9B . There appears to be no effect on warm or cold germination related to treatment at AP2. However, there is possibly a reduction in AA germination with application of AFxRD-038. Only single samples are analyzed per location, so statistical significance is unknown. Also, all germinations are above the critical 90% level required for seed. [0135] Number of Sellable Units per Acre: A representative result for Number of saleable units per acre between locations is shown in FIG. 10A . As expected, there are significantly more saleable units obtained at AP1 (non-stressed) compared to AP2. A representative result for Saleable Units versus Treatment at AP2 (stressed location) is shown in FIG. 10B . While not statistically significant, there were nearly 15% increase saleable units obtained from the VT application at AP2. [0136] Conclusion: There are no visible phytotoxic effects observed from the applications of AFxRD-038 in any of the plots. There are significant differences in almost all of the seed traits due to location but no statistically significant differences related to treatment. The more stressed location, AP2, resulted in lower yield and fewer, smaller and flatter seeds with slightly lower germination. There are trends towards more flat seeds and more saleable units of seed produced per acre (˜15%) with the VT application of AFxRD-038 at the AP2 location. The increase in saleable units seems to be a result of more flats and fewer large round seeds.

1a

CROSS REFERENCE TO RELATED APPLICATIONS This application is a divisional application of pending U.S. application Ser. No. 11/869,861, filed on Oct. 10, 2007. FIELD The present invention relates to chemical dispensing and, more particularly, to a device for selectively dispensing a chemical agent into a targeted environment. BACKGROUND Dispensing of a chemical agent slowly over a period of time is useful in many industries, particularly in the agriculture, railroad and roadway maintenance industries. Conventional application of fertilizers, pesticides and herbicides is time consuming and requires repeated application. Typically, application of these chemical agents is time sensitive for the chemical agent to be effective. Additionally, environmental factors such as rain may wash away the chemical requiring another application within a specified period of time for the chemical to be effective. Various slow dispensing devices have been developed to release small amounts of fertilizer, pesticides or herbicides over an extended period of time. Some of these devices include biodegradable materials impregnated with the chemical to be dispensed. As the biodegradable material decomposes, the chemical is released. Other devices have dissolved the desired chemical in an elastomeric material at a super saturated concentration causing the chemical to bloom to the surface of the elastomer and be dispensed into the surrounding environment. Problems associated with such slow dispensing devices include leaching of chemicals and the danger of exposure to the user, fragile carrier systems whereby the carrier material is susceptible to breakage during handling and installation, or conversely, the carrier material is not biodegradable and requires removal and disposal after a period of time. SUMMARY The present invention includes a biodegradable carrier material wrapped in a biodegradable paper, film or fabric to protect the user from exposure to the chemical in the carrier material, and a biodegradable, braided twine or rope surrounding the carrier material and paper to provide strength and ease of handling to the system. One or more carrier materials may be included each separately wrapped by the paper or wrapped together and surrounded by the rope. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of the chemical application line of the present invention. FIG. 2 is a cross sectional end view of an embodiment of the chemical application line of FIG. 1 . FIG. 3 is a plan view of various uses of the chemical application line of FIG. 1 . FIG. 4 is a perspective view of a placement of the chemical application line around the foundation of a house. FIG. 5 is a perspective view of a placement of the chemical application line around a memorial stone. FIG. 6 is a perspective view of a placement of the chemical application line along a highway. FIG. 7 is a plan view of a placement of the chemical application line along a sidewalk. FIG. 8 is a plan view of a placement of the chemical application line along an intersection. FIG. 9 is a perspective view of a placement of the chemical application line along a fence. FIG. 10 is a plan view of a placement of the chemical application line along a railroad track. FIG. 11 is an elevation and plan view of a placement of the chemical application line in a citrus grove. FIG. 12 is a perspective view of a placement of the chemical application line on a fruit tree branch. DETAILED DESCRIPTION As required, detailed embodiments of the present invention are disclosed herein. However, it is to be understood that the disclosed embodiments are merely exemplary of the invention that may be embodied in various and alternative forms. The figures are not necessarily to scale, some features may be exaggerated or minimized to show details of particular components. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a representative basis for the claims and/or as a representative basis for teaching one skilled in the art to variously employ the present invention. Moreover, except where otherwise expressly indicated, all numerical quantities in this description and in the claims are to be understood as modified by the word “about” in describing the broader scope of this invention. Practice within the numerical limits stated is generally preferred. Also, unless expressly stated to the contrary, the description of a group or class of materials as suitable or preferred for a given purpose in connection with the invention implies that mixtures or combinations of any two or more members of the group or class may be equally suitable or preferred. Referring initially to FIGS. 1 and 2 , a chemical application line of the present invention is generally indicated by numeral 20 . Chemical application line 20 includes core chemical carrier 22 , a paper 24 wrapping the core chemical carrier 22 and a braided rope 26 surrounding the paper 24 and core chemical carrier 22 . Two or more core chemical carriers 22 may be included in the chemical application line 20 . As shown in FIG. 2 , four core chemical carriers 22 are included. Core chemical carriers 22 may include a number of different chemical depending on the specific application. For example, the core application carrier 22 may include fertilizers, pesticides, herbicides, insect attractants, animal repellants or an exothermic chemical heater. Core chemical carrier 22 may include various compostable, biodegradable or degradable binding materials to contain and release the chemical at a desired rate and time. For example, the binding materials may include potato starch, corn starch, tapioca starch or sugar cane fiber individually or mixed in various combinations to achieve a desired decomposition rate according to the application and rate at which the chemical is to be discharged. These materials may decompose within 30 to 180 days or longer depending on the binding material and the environment of the application. A corn starch-based binding material typically decomposes faster than a potato or tapioca starch binding material, for example. For a six-month application of a pesticide, three core carriers 22 may be included in the chemical application line. The binding material of the first core carrier may be made of a corn starch with a decomposition time of 30 days. The second binding material may be made of a combination of corn starch and potato starch with a decomposition time of 90 days. The third binding material may be made of a potato or tapioca starch with a decomposition time of 180 days. In this manner, the pesticide may be released over a six-month period to provide continuous application of the desired pesticide or fertilizer for the desired time. In order for the pesticide to achieve a continuous release, the first binder and pesticide mixture 30 may be homogeneous so that as the binder initially begins to break down, the pesticide is released into the environment. Second core carrier 32 may have an outer layer 34 of binder material only and an inner layer 36 of a binder and pesticide mixture. The outer layer 34 may be formulated to decompose within 30-45 days. When the inner layer 36 is reached, the pesticide begins to be released as the inner layer 36 breaks down. Because the inner layer 36 decomposes at a slower rate than the first binder, for example, a higher concentration of the pesticide may be combined with the inner layer binder 36 so that the release of pesticide is generally constant over the life of the second core carrier 32 . The third core carrier 38 may include an outer layer 40 that decomposes within approximately 90 days with an inner layer 42 mixed with the pesticide that also decomposes within 90 days. The paper 24 wrapping the core chemical carrier 22 protects the user from exposure to the chemical contained within the core chemical carrier 22 . The paper 24 may be a cellulose paper, a fabric, film or other biodegradable coating or wrapping. For example, core chemical carrier 22 may be sprayed or dipped in a starch-based liquid coating to provide a protective layer. The coating 24 may readily decompose or dissolve when exposed to moisture and thereby activate the core chemical carrier 22 . Alternatively, the coating 24 may be of varying thicknesses and thus time to decompose for each of the core chemical carriers 22 to provide a delayed release of the chemicals. The braided rope 26 provides strength to the system and protects the core chemical carriers 22 . The thickness and composition of the rope 26 may be tailored to the environment and the method of application. The rope 26 may be made of natural fibers such as hemp or may be made from sugar cane fibers, starches or other biodegradable materials. Selection of the type of rope 26 may be made based on the application time period of the chemical. Referring to FIGS. 3 and 4 , the chemical application line 20 may be applied along a driveway 50 , a sidewalk 52 , the foundation 54 of a house 56 , around a tree 58 , along a fence 60 , and along a street 62 . For the applications along the driveway 50 , sidewalk 52 , fence 60 and street 62 , the chemical application line 20 may include a fast-acting herbicide, such as a vegetation killer, which may be released for a period of one or more years. The chemical application line 20 around the foundation 54 of house 56 may include a vegetation killer, a pesticide and a rodent repellant. The chemical application line 20 around the tree 58 may include a fertilizer for flowers or other plants around the tree 58 and a rodent repellant to discourage rabbits and other animals from eating the flowers or other plants. Referring to FIG. 5 , the chemical application line 20 may be applied around a memorial stone 70 in a cemetery to keep weeds from growing around the stone 70 and reduce the time necessary for mowing by eliminating the need to trim. Referring to FIG. 6 , the chemical application line 20 may be applied along the top 80 and bottom 82 of a fence line 84 , and along a highway 86 . At the top 80 of fence 84 the chemical application line 20 may include natural repellants to deter nuisance wildlife from entering a roadway, such as deer. Placed along interstates and highways at high risk areas for deer crossings, this deterrent may reduce costly accidents and save the lives of both humans and wildlife. Further placing the chemical application line 20 along the highway including a vegetation killer improves visibility and reduces the time and cost of road maintenance. Additionally, a pesticide may also be included in the chemical application line 20 along the shoulder of the highway 86 to reduce or eliminate damage from fire ants and other pests that build nests along the edge of roads causing the road to weaken and crumble. Referring to FIGS. 7-10 , the chemical application line 20 may be used to fill and treat cracks along walks 90 , walls 92 , curbs 94 , medians 96 , parking lots 98 and railroad tracks 100 , keeping these areas free from weeds. Additionally, medians containing vegetation may be continually fertilized by the release of a fertilizer from the chemical application line 20 . Referring to FIGS. 11 and 12 , the chemical application line 20 may be used in citrus groves 110 to help keep the trees warm during cold weather occurrences. The chemical application line may encapsulate heat packets consisting of iron powder, water, salt, activated charcoal and vermiculate. When the line 20 is stretched, the wrapping (not shown) is torn or broken to allow the compound to be exposed to air triggering an exothermic reaction to warm the citrus grove 110 . The exothermic reaction may last for 6-12 hours. Multiple chemical application lines 20 may be arranged to provide longer term protection from freezing weather. Chemical application line 20 containing insect attractants may be placed in fruit trees 112 to attract bees or other pollinating insects to enhance the yield of the fruit trees 112 . It is to be understood that while certain forms of this invention have been illustrated and described, it is not limited thereto, except in so far as such limitations are included in the following claims and allowable equivalents thereof.

1a

The present application is a continuation-in-part of a copending application Ser. No. 728,998, filed Oct. 4, 1976, now abandoned, entitled EMMITTER FLOW CONTROL TUBE. BACKGROUND This invention is directed to drip or trickle flow irrigation systems utilizing emitters of the flush-drip type such as disclosed in U.S. Pat. No. Re. 29,022 and in copending application Ser. No. 708,062, now U.S. Pat. No. 4,113,180. A problem in the development of drip or trickle irrigation systems, especially for row crops is to produce an inexpensive emitter of the type which undergoes flush flow as well as being capable of essentially constant drip flow over a wide pressure range, and in addition is capable of insertion at low cost in an irrigation flow tube. Another problem encountered in drip or trickle irrigation is the entrance of insects or the exploratory hair roots of plants into the emitter outlets. SUMMARY The present invention is directed to a multiple emitter flow control which is summarized in the following objects: First, to provide a drip or trickle flow emitter system which utilizes an inexpensive normally flat irrigation flow tube capable of being wrapped in a roll to minimize storage and shipping costs, and a series of low cost emitter units which are readily installed in the flow tube and capable of withstanding the forces incidental to wrapping the flow tube in a roll as well as remaining in place as the flow tube is layed in place for irrigation use. Second, to provide an emitter flow control tube having a series of outlets fitted with a series of flush-drip emitters capable of extending radially therein for flush flow; the tube, however, being biased to assume between irrigation cycles a flattened profile whereby its wall opposite the outlets applies a force causing the emitters to bend and in bending close the emitters sufficiently to exclude insects. Third, to provide an emitter flow control tube, as indicated in the preceding object, wherein the tube expands in response to internal water pressure, toward an essentially cylindrical profile to clear the radially inner ends of the emitters and permit expansion thereof to undergo a flush flow phase, followed by collapse to drip flow as the water pressure exceeds a predetermined value. Fourth, to provide an emitter flow control tube as indicated in the preceding object, wherein, on termination of an irrigation cycle, the emitters pass through a flush flow phase as the pressure is reduced, then are bent by the walls of the tube to close the emitters to exclude insects. Fifth, to provide an emitter flow control tube as indicated in the other objects, wherein movement of the tube between its flattened profile and cylindrical profile, as well as the attendent movement of the emitters prevent the entrance of exploratory hair roots of plants. Sixth, to provide an emitter system, an embodiment which utilizes a web on which is installed a series of emitter units; the web then being folded and sealed to form a tube with the emitter units disposed therein. DESCRIPTION OF THE FIGURES FIGS. 1 through 8 illustrate one embodiment of the multiple emitter flow control in which: FIG. 1 is a fragmentary edge view of the multiple emitter flow control shown at approximately full size as it appears between irrigation cycles. FIG. 2 is an enlarged transverse sectional view thereof taken through 2--2 of FIG. 1. FIG. 3 is an end view of an emitter in its flush flow condition. FIG. 4 is a sectional view thereof taken through 4--4 of FIG. 3. FIG. 5 is an enlarged fragmentary longitudinal sectional view of the flow control tube taken through 5--5 of FIG. 2 showing a side view partially in section of an emitter in its fully bent condition. FIG. 6 is an enlarged fragmentary longitudinal sectional view corresponding to FIG. 5, but showing side views, partially in section, of two emitters, one in a slightly bent condition, the other released and assuming a flush flow condition. FIG. 7 is an enlarged fragmentary longitudinal sectional view corresponding to FIGS. 5 and 6 showing the tube in its fully expanded condition and an emitter in its drip flow condition due to pressure of surrounding water. FIG. 8 is a transverse sectional view taken through 8--8 of FIG. 7. FIGS. 9 and 10 illustrate another embodiment of the multiple emitter flow control in which: FIG. 9 is an enlarged transverse sectional view corresponding to FIG. 2 showing a modified form of the flow control tube. FIG. 10 is a fragmentary longitudinal sectional view taken through 10--10 of FIG. 9 showing an emitter in section and in its flush flow condition. FIGS. 11 through 18 illustrate another embodiment of the multiple emitter flow control in which: FIG. 11 is a fragmentary edge view of the emitter flow control tube shown at approximately full size, with an emitter indicated in position. FIG. 12 is an enlarged fragmentary longitudinal view of the emitter flow control tube with an emitter therein shown in side elevation. FIG. 13 is an enlarged transverse sectional view of the emitter flow control tube taken through 13--13 of FIG. 12 with an emitter therein shown in end elevation. FIG. 14 is an enlarged transverse sectional view, corresponding to FIG. 13, showing the emitter flow control tube in its expanded water pressurized condition and the emitter in its drip flow condition. FIG. 15 is a further enlarged inner end view of the emitter in its flush flow condition. FIG. 16 is an inner end view of the emitter corresponding to FIG. 15, showing the emitter in its drip flow condition. FIG. 17 is a further enlarged sectional view of the emitter shown in its flush condition and taken through 17--17 of FIG. 15. FIG. 18 is a further enlarged sectional view of the emitter in its drip flow condition taken through 18--18 of FIG. 16. DETAILED DESCRIPTION Referring to FIGS. 1 through 8, the multiple emitter flow control herein shown preferably utilizes a series of emitter units 1 of the flush-drip type such as shown in copending application Ser. No. 708,062, with the exception that the base is modified to be fitted in a flow control tube. More specifically, the emitter unit 1 includes an outside or base flange 2, joined to a short neck 3, which in turn, is joined to an inside flange 4, the flanges and neck being circular in cross section. The second flange 4 is joined to an emitter tube 5 having confronting arched walls 6 joined at their lateral edges by thin webs 7. The arched walls form therebetween, when free of stress, a flush flow passage 8 joined to an outlet passage 9 extending through flange 4, neck 3 and flange 2. Formed in one of the arched walls 6 is a channel 10 which, when closed by the other wall, forms a drip flow passage, the size of which depends on irrigation requirements which may range from a fraction of a gallon per hour to two or three gallons per hour. For a one gallon per hour flow the drip passage is approximately 0.020 inches by 0.015 inches (0.0508 cm by 0.0381 cm). The emitter unit 1 is formed of highly flexible and resilient elastomeric material even though held under moderate stress for long periods. Materials having such properties are well known. Furthermore, the walls 6 and the webs 7 are as thin as possible to minimize the force required to bend or flatten the emitter tube for drip flow therethrough. The flow tube, designated 11, is an extrusion of plastic material selected from the materials now available for irrigation purposes. The flow tube normally, that is when not internally pressurized, has a flat profile with lateral margins 12 having an acute radius, which are connected by essentially flat or slightly arched side walls 13 and 14. One of the side walls, such as the side wall 14 is provided with a series of perforations 15 spaced in accordance with the type of crop to be irrigated. In this regard, the perforations may be as close as six inches or as far as three feet or more. The emitter units 1 are secured in the flow tube 11 by forcing the emitter tubes 5 and inside flange 4 through corresponding perforations 15 until stopped by the larger outside flange 2. It is preferred to orient the emitter tubes perpendicular to the longitudinal axis of the flow tube 11 as shown in FIGS. 1, 2, 5, 6 and 7; however, tests have indicated that the emitter tubes may be oriented in the longitudinal plane of the flow tube, or in an intermediate position. Referring principally to FIGS. 5, 6 and 7, when the flow tube is free of internal pressure, such as between irrigation cycles, the flow tube is relatively flat as shown in FIG. 5 and the length of the emitter tube is greater than the distance between the flow tube walls 13 and 14. Consequently, the emitter tube may be bent as much as 90° as indicated by 16. Under this condition, at least at the base end, the emitter tube is flattened causing mutual engagement of the walls 13 and 14 and closing off the flush flow passage, leaving only the drip passage or channel 10 open. Also under this condition, drip flow permits slow escape of residual water; however, the size of the drip passage, which is, as indicated previously, in the order of only a few thousandths of an inch, excludes insects except microorganisms which pose far less a problem. It should be noted that the flow tube is formed of plastic material selected to have substantially greater strength than the emitter tube; that is, the bending resistance of the emitter tube 1 is substantially less than the force exerted by the flow tube 11 as it assumes its normal flat condition. When irrigation is initiated, the water pressure increases from zero pressure and causes the flow tube to expand permitting the emitter tubes 1 to straighten as indicated by 17a and 17b in FIG. 6. The amount of tube expansion which occurs before the wall 13 clears the emitter tube depends upon the length of the emitter tube and the diameter of the flow tube. It is preferred to proportion the flow tube and emitter tubes so that, under irrigation pressure, the emitter tubes extend slightly more than half the diameter of the flow tube as indicated by 18 in FIG. 7. As the flow tube expands slightly beyond the position indicated by 17a in FIG. 6, the emitter tube is freed. The strength and size of the flow tube as well as the length of the emitter tube are calculated so that when the emitter tube is first free of the flow tube wall, the water pressure is below that required to collapse the emitter tube; hence, the emitter tube assumes a flush flow condition, as indicated by 17b in FIG. 6, which terminates when the water pressure exceeds the strength of the arched walls and causes closure to drip flow as indicated by 18 in FIG. 7. It should be noted that flush flow may be adequate, even though the duration of flush flow is extremely short, for the area at the entrance of the emitter tube which may require flushing is relatively small. Control of the amount of flush flow may be accomplished by the rate at which the irrigation water is supplied. When the irrigation cycle is terminated, the rate at which the flow tube collapses is relatively slow resulting in a greater duration of flush flow period. This is desirable, as accumulation of matter requiring flushing occurs during the irrigation cycle, and usually the flushing action occuring at the end of the irrigation cycle is adequate. Thus during initiation of the irrigation cycle, flush flow is supplementary. Referring to FIGS. 9 and 10, a flow tube 19 is illustrated which is formed from a flat web, the web being rolled into a tubular form and joined by bonded margins 20, for example, in the manner disclosed in U.S. Pat. No. 2,491,048. First, however, perforations 21 are formed and emitter units 22 are secured in place. The normal profile of the tube 19 is similar to the flow tube 11 and when subjected to internal pressure, expands as illustrated in FIGS. 5, 6 and 7. The emitter units 22 are similar to the emitter units 1 except an inside flange 23 is provided which is of sufficient area as to be peripherally bonded, as indicated by 24 to a surface surrounding a perforation 21, which becomes an inner surface of the tube 19. Like the emitter units 1, each emitter unit 22 is provided with a neck 25, fitting a perforation 21, and an outside flange 26, which however, may be smaller than the flange 23. The remaining portions of the emitter unit 22 may be the same as the corresponding portions of the emitter unit and are similarly identified. Operation of the embodiment shown in FIGS. 9 and 10 is essentially the same as the first described embodiment. Referring to FIGS. 11 through 18, the emitter unit 27 therein illustrated includes an outside or base flange 28 joined to a short neck 29, which in turn, is joined to an inside flange 30, the flanges and neck being of circular cross section. The flange 30 is joined to a short emitter tube 31 having confronting arched walls 32 joined at their lateral edges by thin webs 33. When free of stress, the arched walls form therebetween a flush flow passage 34 terminating at its inner end in a pair of converging walls 35 merging into an outlet passage 36. Formed in one of the arched walls 32 is a drip flow channel 37. The channel is offset so as to terminate at one of the converging walls 35 rather than communicating directly with the outlet passage 36. As indicated in FIG. 18, the drip flow channel 37 communicates under drip flow with the outlet passage 36 through a connecting passage 38 formed by the walls 32 and corresponding wall 35. As the connecting passage is larger than the drip flow channel, it does not interfer with drip flow. The emitter unit 27 is fitted in a flow tube 11 in the manner of the emitter 1. In conducting tests with an emitter corresponding to emitter unit 1, the length of the emitter tube 5 was progressively reduced in length. Surprisingly, shortening the tube 5 appeared to have no appreciable effect on the pressure at which drip flow occurred or in the constriction of the drip flow passage with increased pressure; that is, essentially constant flow over a wide range of flow continued to occur. Tests with the emitter corresponding to emitter unit 1 indicated that installation could be improved if the width were reduced to the diameter of the neck 3 and the opening 15 which tests had indicated could be approximately the same as the neck 3. Also, with the drip flow channel 10 in alignment with discharge passage 9 the water tended to issue as a jet which placed the water as much as two or three feet from the tube 11, instead of in the immediate vicinity of the tube 11 as accomplished by trickle or drip discharge. The jet discharge did not, however, appeciably change the rate of flow. Consequently, a test mold was made to produce an emitter unit 27, as shown in FIGS. 11 through 18. The drip flow channel was reduced in size calculated to reduce flow to approximately 1/2gal. per hour (1.89 letters) Tests were made of the emitter unit 27 with a tube length X of 1/8in. (3.17 mm) and a tube length Y of 1/16 in. (1.59 mm) as indicated in FIG. 17. The tests indicated that the actual drip flow rate was close to the intended drip flow rate of 1/2gal. per hour and was nearly constant throughout a pressure range between 5 and 40 lbs/sq. in. (2.27 kilograms and 1.81 kilograms/sq.). The flow rate of the Y length emitter tube was sligntly lower than the X length emitter tube between 5 and 20 lbs/sq. in. Whereas the two flow rates tended to become equal in the range between 20 and 40 lbs/sq. in. (0.905 kilograms and 1.81 kilograms). In the course of tests with emitter tubes of such short length, it was observed that under mechanical force applied to a short length of open ended flow tube containing an emitter unit to cause the tube transition from a flat shape toward a circular shape, the inner flange 30 of the emitter unit tended to curve into conformity with the flow tube wall. This tendency to conform also was observed when a clear flow tube was used and subjected to water pressure as indicated by arrows 39 in FIG. 18. The tendency of the inner flange 30 to conform to the curvature of the flow tube wall produced an unexpected result; namely, when the emitter tube was positioned with its major width parallel to the axis of the flow tube, as shown in FIGS. 11 through 18, the conforming movement of the inner flange 30, exerted a force, separate from the force of water pressure, on the emitter tube in the direction of the arrows 40 in FIG. 18 tending to close the emitter tube toward drip flow. Thus it seems that the closing force on the emitter tube is greater than would be accounted for by water pressure on the emitter tube itself. When the short emitter tube 31 is placed as shown in FIGS. 1 through 10, conformity of the inner flange with the flow tube causes the walls 32 to increase their arch, spreading the walls 32 in opposition to water pressure. If the emitter tube area is substantial, as in FIGS. 1 through 10, the force exerted by the inner flange 30 is not significant; however, when the emitter tube is shortened as in FIGS. 11 through 18, the force exerted by the inner flange is significnat as it increases the flush flow cutoff pressure if major width of the emitter tube is transverse to the flow tube axis and decreases the flush flow cutoff pressure if the major width of the emitter tube is parallel to the flow tube axis. In order to place the emitter tube in the desired orientation, the outer flange is provided with a channel 41 or other external marking. It will be noted that the orientation of the emitter tube 31 is the same as the emitter tube 5 as shown in FIGS. 9 and 10 and that the inner flange 24 and base end of the emitter unit 22 exerts a force similar to the inner flange 30. It will also be noted that the neck 29 is of greater length than the wall thickness of the flow tube 11, and that an interference fit is preferred to a fit which would constrict the outlet passage 36. The extra length of the neck 29 aids in thrusting the inner flange 24 through the opening 15. Once inserted, water pressure causes the inside to conform to and seal the opening 15. It will be further noted that the embodiments shown in FIGS. 1 through 10 are preferred where the insect problem is substantial; however, if the tube 11 has a sufficiently flat profile and a capability to maintain such profile between irrigation cycles, the emitter tubes 31 are closed as shown in FIGS. 11, 12 and 13. Furthermore, even though the emitter tubes 31 are short, the emitter units 27 may be formed of elastomeric material which is sufficiently flexible as to fold under a small force exerted by the tube 11. Having fully described our invention it is to be understood that we are not to be limited to the details herein set forth, but that our invention is of the full scope of the appended claims.

1a

[0001] The present disclosure relates to a dose indicator device and apparatus comprising such devices, and in particular to a dose indicator device for use with, or incorporated as part of a pressurised metered dose inhaler. BACKGROUND [0002] It has been recognised that there is a need to provide accurate information to a user of a dispensing apparatus, such as a pressurised metered dose inhaler, concerning the quantity of doses delivered from, or remaining in, the dispensing apparatus. Without such information, there is a danger that a user may be unaware that the dispensing container of the dispensing apparatus is empty or close to empty. This is especially dangerous where the dispensing apparatus is for use in delivering medicinal compounds for the treatment of chronic or acute symptoms, for example, as in the case of a pressurised metered dose inhaler used for treating asthmatic reactions. [0003] It is known to provide a dispensing apparatus with a dose indicator device. Typically such dose indicator devices are triggered by movement of the dispensing container wherein the movement either directly or indirectly provides the motive force for incrementing or decrementing the dose indicator device. EP1758631 disclose one example of a dose indicator device. This device, while accurate and robust, comprises a relatively large number of separate components. [0004] It would be desirable to produce a dose indicator device that requires fewer components. SUMMARY OF THE DISCLOSURE [0005] According to the present disclosure there is provided a dose indicator device for a pressurised metered dose inhaler comprising: [0006] an inner wheel, an annular outer wheel, an actuator and a housing; [0007] the inner wheel comprising a plurality of primary indexing teeth and a flexible drive arm; [0008] the annular outer wheel comprising a plurality of secondary indexing teeth on an outer face of the annular outer wheel; [0009] the inner wheel and outer annular wheel being located at least partially within the housing such that the inner wheel and annular outer wheel are rotatable about a common longitudinal axis of rotation; [0010] the actuator being movable in a plane perpendicular to the longitudinal axis of rotation to engage the primary indexing teeth of the inner wheel to rotate the inner wheel; [0011] the housing being fixed relative to the longitudinal axis of rotation and comprising a deflector; [0012] the deflector being configured such that, on rotation of the inner wheel, the flexible drive arm is intermittently deflected by the deflector and is thereby brought into contact with the secondary indexing teeth so as to rotate the annular outer wheel about the axis of rotation. [0013] Advantageously, the dose indicator device comprises a relatively small number of separate components and is suitable to form a compact, space-saving design. [0014] The inner wheel may be cylindrical in shape and may be solid or may be provided with a central bore. The inner wheel may have a stepped diameter with portions of different diameter. [0015] The annular outer wheel may have the form of a ring and may be circular in shape. [0016] The inner wheel may be at least partially nested within the longitudinal extent of the annular outer wheel. By arranging the inner wheel at least partly within the annular outer wheel the ‘depth’ of the dose indicator device measured in a direction along the longitudinal axis of rotation may be minimised, since it is not necessary to stack the two wheels one upon the other. [0017] The deflector may be configured such that, on rotation of the inner wheel, the flexible drive arm is intermittently deflected by the deflector inwardly towards the longitudinal axis. [0018] In one aspect a proximal end of the flexible drive arm of the inner wheel may be located closer to the longitudinal axis than the secondary indexing teeth and a distal end of the flexible drive arm may be located further from the longitudinal axis than the secondary indexing teeth when not in contact with the deflector. Thus, the flexible drive arm is enabled to engage the secondary indexing teeth on the outer face of the annular outer wheel. [0019] The housing may further comprise a first flexible restraint which engages the inner wheel to restrain rotation of the inner wheel when not being rotated by the actuator and a second flexible restraint which engages the annular outer wheel to restrain rotation of the annular outer wheel when not being rotated by the inner wheel. [0020] The restraints advantageously serve to restrain movement of the inner wheel and annular outer wheel other than when the wheels are being positively driven during a counting action. This helps to minimise the chances of the dose indicator device changing the displayed indication if the device is dropped, shaken or otherwise knocked. [0021] The inner wheel may comprise a plurality of indentations on an outer face of the inner wheel which are engagable by the first flexible restraint. The plurality of indentations may be located circumferentially around the inner wheel with the primary indexing teeth located to one side of the plurality of indentations. The indentations may have a cross-sectional shape that is part-circular or otherwise smoothly curved and the portion of the first flexible restraint that engages the indentations may have a matching circular shape. [0022] The second flexible restraint may be engagable with the secondary indexing teeth of the annular outer wheel. The secondary indexing teeth may have a cross-sectional shape that is part-circular or otherwise smoothly curved and the portion of the second flexible restraint that engages the secondary indexing teeth may have a matching circular shape. [0023] The housing may comprise a mounting aperture for the inner wheel enabling the inner wheel to rotate therein relative to the housing. Advantageously the housing may function to mount and locate the annular outer wheel and the inner wheel relative to one another while allowing both wheels to rotate. [0024] In one aspect the inner wheel may comprise a plurality of indentations on an outer face of the inner wheel which are engagable by the first flexible restraint and wherein the plurality of indentations form the bearing surface of the inner wheel in the mounting aperture. In this aspect, a portion of a boundary of the mounting aperture may comprise a first flexible restraint which is engagable with the plurality of indentations of the inner wheel to restrain rotation of the inner wheel when not being rotated by the actuator. [0025] In one aspect the actuator may be provided on an actuator member, said actuator member being movable by a dispensing container of a pressurised metered dose inhaler into an indexing position on actuation of the pressurised metered dose inhaler to engage the actuator with the primary indexing teeth of the inner wheel to rotate the inner wheel; wherein said actuator member may be biased away from the indexing position such that the actuator is disengaged from the primary indexing teeth when the pressurised metered dose inhaler is in a non-dispensing position. [0026] The actuator member may take the form of a plunger or carriage which is slidable relative to an actuator housing of the pressurised metered dose inhaler. The actuator member may comprise a head part that in use is contacted by a part of the dispensing container of the pressurised metered dose inhaler (such as the valve ferrule), a stem part that movably mounts the actuator member to the housing of the pressurised dispensing container and the actuator itself which may be in the form of a flexible arm. The actuator member may comprise an aperture into or through which a portion of the inner wheel extends so as to locate the primary indexing teeth in alignment with the actuator. Again, this allows for a more compact arrangement of the components. The biasing of the actuator member may be achieved by providing a compression spring between the stem part and the actuator housing or by integrating a flexible, sprung leg into the actuator member that is compressed and strained during actuation of the pressurised metered dose inhaler. In one aspect, the head part of the actuator member comprises an annular yoke through which on assembly a valve stem of the pressurised dispensing container projects. In this aspect the stem part may comprise a carriage that slides within a C-section channel provided on the actuator housing. The stem part may comprise at least one downwardly extending leg on which is provided the flexible arm actuator. The C-section channel comprises the aperture allowing the inner wheel to project therethrough. [0027] The intermittent engagement of the one or more secondary indexing teeth of the inner wheel and the indexing teeth of the annular outer wheel serve to enable the annular outer wheel to be incremented only after a plurality of rotational increments of the inner wheel. For example, the inner wheel and the annular outer wheel may have a gear ratio such that for every 10 incremental rotations of the inner wheel the annular outer wheel is incrementally rotated once. Consequently, for every 10 actuations of the inner wheel by the actuator the inner wheel will rotate through 360° and the flexible drive arm of the inner wheel will be deflected to engage the secondary indexing teeth of the annular outer wheel once to rotate it one increment. In another example, a gear ratio of 10:1 can be achieved by providing two flexible drive arms on the inner wheel at 180° spacing, two deflectors on the housing at 180° spacing and 20 primary indexing teeth. Other gear ratios can be used as desired. For example, the annular outer wheel can be arranged to incrementally rotate every 20 actuations of the pressurised dispensing container by providing one flexible drive arm and 20 primary indexing teeth on the inner wheel. [0028] The housing may comprise a first housing part which is engagable with a wall portion of an actuator housing of a pressurised metered dose inhaler to define a housing enclosure containing the inner wheel and annular outer wheel. Advantageously, the components of the dose indicator device are kept in correct alignment by being held between the housing of the dose indicator device and the actuator housing which therefore requires fewer components than needed for a dose indicator housing that itself fully defines the housing enclosure. [0029] The first housing part may comprise the deflector. [0030] The inner wheel and/or annular outer wheel may comprise dosage indicia. The dosage indicia may be in the form of numbers, words, letters, colours, pictograms or similar. For example a decreasing series of numbers can be displayed: 200, 190, 180, 170, etc. where a gear ratio of 10:1 is used between the inner wheel and the outer annular wheel. Alternatively, where it is not desired to show a numerical count but simply to indicate to a user that the end of the useful life of the pressurised metered dose inhaler is approaching, the indicia could be in the form of a changing colour, e.g. a display that changes from green, through orange to red, or in the form of words which are displayed near or at the end of the pack life such as “Order replacement now” and “Empty”. [0031] Dosage indicia may be presented only on the annular outer wheel where individual dosage counts are not to be displayed to a user. Alternatively, the inner wheel may also be provided with dosage indicia where individual dosage counts are desired to be displayed. [0032] The dosage indicia may be provided on an end face of the inner wheel and/or outer wheel, the end faces being perpendicular to the longitudinal axis. [0033] The present disclosure also relates to a pressurised metered dose inhaler comprising an actuator housing, a pressurised dispensing container received in the actuator housing and a dose indicator device as described in any of the aspects above. [0034] The pressurised metered dose inhaler may comprise a housing enclosure containing the inner wheel and annular outer wheel, the housing enclosure being defined by a first housing part of the dose indicator device and a wall portion of the actuator housing. [0035] The wall portion may comprises a rear wall of the actuator housing such that the housing enclosure is located between a stem block and the rear wall of the actuator housing. Advantageously, positioning the dose indicator to the rear of the stem block permits a clear airway to be provided between the stem block and the front of the actuator housing. [0036] In one embodiment, the actuator housing may be formed from two mouldings, comprising a front case and a rear case. The front case may comprise the dispensing orifice (mouthpiece or nasal piece for example). The actuator housing may have a split line between the front and rear cases that runs down the length of the actuator housing to split the compartment receiving the pressurised dispensing container in two. The front and rear cases may be joined by a snap-fit arrangement. [0037] In an alternative embodiment, the actuator housing may be formed from two mouldings, comprising a top case and a bottom case. The bottom case may comprise the dispensing orifice (mouthpiece or nasal piece for example). The top and bottom cases may be joined by a snap-fit arrangement. [0038] The pressurised metered dose inhaler may further comprise a window in the actuator housing for viewing the inner wheel and/or outer wheel therethrough. [0039] The window may be sized so as only to show the annular outer wheel and to obscure view of the inner wheel. Alternatively both wheels may be visible. [0040] The components of the dose indicator device and actuator housing are preferably formed from plastics mouldings, except for the compression spring (when present) which may be metal or plastic. [0041] Rigid components of the dose indicator device may be formed from, for example, polyester, nylon, polypropylene, polyacetal, ABS or similar. [0042] Preferably, the flexible drive arm, flexible restraints and the actuator drive arm are formed from an elastic material such that imparted strains during normal actuation are recoverable elastically. A suitable example is polyacetal (POM). [0043] The dose indicator device may be used with, or form a part of a pharmaceutical dispensing device, such as, for example, a pulmonary, nasal, or sub-lingual delivery device. A preferred use of the dose indicator device is with a pharmaceutical pressurised metered dose aerosol inhaler device. The term pharmaceutical, as used herein, is intended to encompass any pharmaceutical, compound, composition, medicament, agent or product which can be delivered or administered to a human being or animal, for example pharmaceuticals, drugs, biological and medicinal products. Examples include antiallergics, analgesics, bronchodilators, antihistamines, therapeutic proteins and peptides, antitussives, anginal preparations, antibiotics, anti-inflammatory preparations, hormones, or sulfonamides, such as, for example, a vasoconstrictive amine, an enzyme, an alkaloid, or a steroid, including combinations of two or more thereof. In particular, examples include isoproterenol [alpha-(isopropylaminomethyl) protocatechuyl alcohol], phenylephrine, phenylpropanolamine, glucagon, adrenochrome, trypsin, epinephrine, ephedrine, narcotine, codeine, atropine, heparin, morphine, dihydromorphinone, ergotamine, scopolamine, methapyrilene, cyanocobalamin, terbutaline, rimiterol, salbutamol, flunisolide, colchicine, pirbuterol, beclomethasone, orciprenaline, fentanyl, and diamorphine, streptomycin, penicillin, procaine penicillin, tetracycline, chlorotetracycline and hydroxytetracycline, adrenocorticotropic hormone and adrenocortical hormones, such as cortisone, hydrocortisone, hydrocortisone acetate and prednisolone, insulin, cromolyn sodium, and mometasone, including combinations of two or more thereof. [0044] The pharmaceutical may be used as either the free base or as one or more salts conventional in the art, such as, for example, acetate, benzenesulphonate, benzoate, bicarbonate, bitartrate, bromide, calcium edetate, camsylate, carbonate, chloride, citrate, dihydrochloride, edetate, edisylate, estolate, esylate, fumarate, fluceptate, gluconate, glutamate, glycollylarsanilate, hexylresorcinate, hydrobromide, hydrochloride, hydroxynaphthoate, iodide, isethionate, lactate, lactobionate, malate, maleate, mandelate, mesylate, methylbromide, methylnitrate, methylsulphate, mucate, napsylate, nitrate, pamoate, (embonate), pantothenate, phosphate, diphosphate, polygalacturonate, salicylate, stearate, subacetate, succinate, sulphate, tannate, tartrate, and triethiodide, including combinations of two or more thereof. Cationic salts may also be used, for example the alkali metals, e.g. Na and K, and ammonium salts and salts of amines known in the art to be pharmaceutically acceptable, for example glycine, ethylene diamine, choline, diethanolamine, triethanolamine, octadecylamine, diethylamine, triethylamine, 1-amino-2-propanol-amino-2-(hydroxymethyl)propane-1,3-diol, and 1-(3,4-dihydroxyphenyl)-2 isopropylaminoethanol. [0045] The pharmaceutical will typically be one which is suitable for inhalation and may be provided in any suitable form for this purpose, for example as a solution or powder suspension in a solvent or carrier liquid, for example ethanol, or isopropyl alcohol. Typical propellants are HFA134a, HFA227 and di-methyl ether. [0046] The pharmaceutical may, for example, be one which is suitable for the treatment of asthma. Examples include salbutamol, beclomethasone, salmeterol, fluticasone, formoterol, terbutaline, sodium chromoglycate, budesonide and flunisolide, and physiologically acceptable salts (for example salbutamol sulphate, salmeterol xinafoate, fluticasone propionate, beclomethasone dipropionate, and terbutaline sulphate), solvates and esters, including combinations of two or more thereof. Individual isomers such as, for example, R-salbutamol, may also be used. As will be appreciated, the pharmaceutical may comprise of one or more active ingredients, an example of which is flutiform, and may optionally be provided together with a suitable carrier, for example a liquid carrier. One or more surfactants may be included if desired. BRIEF SUMMARY OF THE DRAWINGS [0047] Embodiments of the present disclosure will now be described, by way of example, with reference to the accompanying drawings, in which:— [0048] FIG. 1 is a perspective view of a pressurised metered dose inhaler comprising a dose indicator device according to the present disclosure and including a pressurised dispensing container; [0049] FIG. 2 is an exploded perspective view of the pressurised metered dose inhaler of FIG. 1 ; [0050] FIG. 3 is an exploded perspective view of the pressurised dispensing container of FIG. 1 from another angle; [0051] FIG. 4 is an exploded perspective view of the pressurised dispensing container of FIG. 1 from another angle; [0052] FIG. 5 is a side elevation of a portion of a dose indicator device according to the present disclosure; [0053] FIG. 6 is a cross-sectional view of the portion of the dose indicator device of FIG. 5 ; [0054] FIG. 7 is an end elevation of the portion of the dose indicator device of FIG. 5 ; [0055] FIG. 8 is an exploded perspective view of the portion of the dose indicator device of FIG. 5 ; [0056] FIG. 9 is an exploded perspective view of the portion of the dose indicator device of FIG. 5 from another angle; [0057] FIG. 10 is a perspective view of another embodiment of pressurised metered dose inhaler comprising a dose indicator device according to the present disclosure and including a pressurised dispensing container; [0058] FIG. 11 is a rear view of the pressurised metered dose inhaler of FIG. 10 ; and [0059] FIG. 12 is a cross-sectional view of the pressurised metered dose inhaler of FIG. 10 . DETAILED DESCRIPTION [0060] FIG. 1 shows a pressurised metered dose inhaler 1 which comprises an actuator housing 2 that contains a pressurised dispensing container 3 . [0061] The actuator housing 2 comprises a generally tubular body 7 and a depending mouthpiece 6 at one end covered by a dust cap 106 . The tubular body 7 may have a generally circular cross-sectional shape. However, in the illustrated example the tubular body 7 comprises a squarer cross-sectional shape with a front wall 7 a , side walls 7 b and rear wall 7 c . A stem block 8 is provided at a basal end of the tubular body 7 nearest the mouthpiece 6 . The actuator housing 2 may be formed from two mouldings comprising a front case 17 a and a rear case 17 b . The front case 17 a comprises the mouthpiece 6 and a portion of the tubular body 7 comprising the front wall 7 a and half of each side wall 7 b . In addition; the front case 17 a comprises a base 7 d of the actuator housing 2 from which project the stem block 8 , a C-section channel 8 and a tubular extension 10 defining a bore. The C-section channel 80 comprises an aperture 81 . The rear case 17 b comprises the rear wall 7 c and the remainder of the side walls 7 b . A rim 71 provided on an inner face of the rear case 17 b , as shown in FIG. 4 , defines a cavity 71 a the function of which will be described below. The rim 71 is generally circular except for a flattened section 71 a . The front and rear cases 17 a , 17 b may be snap-fit together by means of formations 7 e on each casing. A viewing window 62 in the form of a cut out is provided in the rear wall 7 c of the actuator housing 2 . A lock-out aperture 61 is provided in the front wall 7 a just above the mouthpiece 6 . The dust cap 106 is provided with a body that encloses the mouthpiece 6 and a tang 161 that in use can protrude through the lock-out aperture 61 when the dust cap 106 is in position on the mouthpiece 6 . [0062] The pressurised dispensing container 3 typically comprises a canister 4 and a valve (not shown). To assemble the pressurised metered dose inhaler, the dispensing container 3 is inserted into an open end 7 f of the tubular body 7 of the housing 2 such that a valve stem of the valve is received in the stem block 8 . [0063] According to the present disclosure, the pressurised metered dose inhaler 1 includes a dose indicator device marked generally by reference 9 . The dose indicator device is located towards the mouthpiece end of the tubular body 7 situated between the stem block 8 and the rear wall 7 c. [0064] In general the dose indicator device 9 comprises an inner wheel 11 , an annular outer wheel 12 , an actuator member 13 , a cup-shaped housing 70 and a spring 15 . The cup-shaped housing 70 of the dose indicator device 9 defines, together with the rear wall 7 c , a housing enclosure of the dose indicator device 9 which locates and aligns the inner wheel 11 and annular outer wheel 12 . [0065] In the following description, unless the context otherwise requires, the term “inwardly-facing” refers to a direction which is inwards towards the pressurised dispensing container 3 within the tubular body 7 . The term “outwardly-facing” refers to a direction which is outwards away from the pressurised dispensing container 3 within the tubular body 7 . Further, unless the context otherwise requires, terms such as “upwards” refer to the direction towards the open end 7 f of the tubular body 7 while terms such as “downwards” refer to the opposite direction. [0066] The inner wheel 11 comprises a generally solid cylindrical body 20 that is mounted in use to rotate about a first rotational axis 21 as marked on FIG. 5 . The body 20 is provided with three layers which are positioned adjacent to one another in a direction along the first rotational axis 21 . The first layer comprises a plurality of primary indexing teeth 22 . In the example shown there are 10 primary indexing teeth 22 . Adjacent the primary indexing teeth 22 is the second layer which comprises a plurality of indentations 24 . Each indentation 24 takes the form of a part circular cut out in the body 20 of the inner wheel 11 . In the example shown there are 10 indentations 24 , 1 for each of the primary indexing teeth 22 . Adjacent the indentations 24 is the third layer which comprises a flexible drive arm 23 . The flexible drive arm 23 comprises an arm portion 23 a that depends from the body 20 and terminates at a distal end with a circular pin 23 b . As shown most clearly in FIG. 9 , an end face 20 a of the body 20 of the inner wheel 11 comprises a peripheral rebate 25 . [0067] The annular outer wheel 12 , as shown in FIG. 8 , has a generally annular body 30 which in use is rotatable about the longitudinal axis 21 . The body 30 comprises an annular portion 38 a dependent flange 36 . The annular body 30 defines a central aperture 31 which accommodates on assembly as described below a portion of the inner wheel 11 . The flange 36 extends both radially outwards of the annular portion 38 and also for a distance radially inwardly of the annular portion 38 to define an annular shoulder 39 as shown in FIG. 8 . A plurality of indexing teeth 33 are provided around an outer face of the annular portion 38 . In the example shown 21 indexing teeth 33 are provided. As well as the indexing teeth 35 , the outer face of the annular portion 38 is provided with a land 33 a the function of which will be described below. [0068] An outwardly-facing face 36 a of the flange 36 and/or the end face 20 a of the inner wheel 11 are provided with one or more indicia to provide information to a user of the pressurised metered dose inhaler 1 regarding the number of doses dispensed from the inhaler or remaining in the inhaler. For example, the indicia may comprise a set of increasing or decreasing numbers, a series of pictograms, a series of words or a band of changing colour—e.g. a band which changes from green to red around the circumference of the annular outer wheel 12 . [0069] As shown in FIGS. 2 to 4 , the actuator member 13 comprises a yoke 41 at its upper end from which depend two legs 42 defining a channel 44 therebetween. An actuator drive arm 45 in the form of a flexible extension is provided on one of the legs 42 facing, and extending into, the channel 44 . In use, as described below the actuator drive arm 45 drives the rotation of the inner wheel 11 . Also depending from the yoke 41 is a plunger rod 46 . [0070] The cup-shaped housing 70 is shown most clearly in FIGS. 8 and 9 . The cup-shaped housing 70 comprises a body 50 which has a generally disc-shaped planar portion 51 and a dependent rim 52 which is generally circular except for a flattened section 52 a . A projection 74 located at one point of the periphery of the body 50 projects perpendicularly to the planar portion 51 . The disc-shaped portion 51 of the body 50 comprises a centrally-located aperture 54 bounded by a rim 54 a which, as described below, in use accommodates a portion of the inner wheel 11 . A portion of the rim 54 a is interrupted and in the gap is provided a first flexible restraining arm 57 in the form of a flexible arm portion which has a circular pin at its distal end. A second flexible restraining arm 55 that again has a circular formation at its distal end is provided on the inner face of the rim 52 . Opposite the restraining arm 55 is provided on the inner face of the rim 52 a deflector 59 the function of which will be described below. [0071] To assemble the pressurised metered dose inhaler 1 , the annular outer wheel 12 , inner wheel 11 and cup-shaped housing 70 are first nested together. When nested the primary indexing teeth 22 of the inner wheel 11 project through the aperture 54 with the indentations 24 being aligned with and bearing against the inner face of the rim 54 a . Also the peripheral rebate 25 of the inner wheel 11 engages against the shoulder 39 of the annular outer wheel 12 . With the inner wheel 11 and annular outer wheel 12 nested together the pin 23 b of the flexible drive arm 23 lies radially just outwards of the location of the indexing teeth 33 of the annular outer wheel 12 but extends in the direction of the longitudinal axis 21 to be in line with the plane of the indexing teeth 33 as shown in FIG. 6 . As such, the arm portion 23 a of the flexible drive arm 23 spans the annular portion 38 . At the same time, the restraining arm 55 of the cup-shaped housing 70 is engaged with one of the indexing teeth 33 . The flange 36 is fully received within the cavity of the cup-shaped housing 70 . As such, a very compact arrangement is obtained as shown in FIG. 5 where the depth of the inner wheel 11 and annular outer wheel 12 are fully contained within the depth of the cup-shaped housing 70 . [0072] The nested annular outer wheel 12 , inner wheel 11 and cup-shaped housing 70 are then inserted into the cavity 71 a defined by the rim 71 of the rear case 17 b . The rim 71 serves to locate the other components and prevent rotation of the cup-shaped housing 70 relative to the rear case 17 b by virtue of the inter-engagement of the flattened sections 52 a and 71 b. [0073] Next, the spring 15 is inserted into the bore of the tubular extension 10 . The actuator member 13 is then inserted with the two legs 42 being slidingly received in the C-section channel 80 . At the same time the plunger rod 46 is engaged in the open end of the bore of the tubular extension 10 so as to contact and rest on the upper end of the spring 15 . [0074] The front and rear cases 17 a and 17 b are then fastened together. Once fastened the cup-shaped housing 70 is abutted against the rear face of the C-section channel 80 such that the indexing teeth 22 of the inner wheel 1 project through the aperture 81 in the C-section channel 80 into alignment with the legs 42 and flexible drive arm 45 of the actuator member 13 . The abutment prevents any of the components becoming disengaged from one another. In addition, when abutted the projection 74 of the cup-shaped housing spans across the top of the C-section channel 80 preventing the actuator member 13 from becoming detached from the C-section channel is the actuator housing is inverted. [0075] A pressurised dispensing container 3 can now be inserted through the open end 7 f of the tubular body 7 such that a leading face of a ferrule of the dispensing container 3 contacts the yoke 41 of the actuator member 13 . The aperture in the middle of the yoke 41 accommodates the valve stem to enable it to project beyond the yoke 41 into engagement with the stem block 8 . The action of the spring 15 on the base of the plunger rod 46 ensures that in the rest position, the yoke 41 is held in face to face contact with the ferrule of the dispensing container 3 . [0076] FIGS. 6 and 7 illustrate the relative positions of the inner wheel 11 , annular outer wheel 12 and cup-shaped housing 70 at the rest position. At rest, the distal end of the actuator drive arm 45 is out of contact with the primary indexing teeth 22 of the inner wheel 11 . Also, in this rest position, the first flexible restraining arm 57 is engaged with one of the indentations 24 of the inner wheel 11 and the second flexible restraining arm 55 is engaged with one of the indentations 33 of the annular outer wheel 12 . The purpose of the first and second flexible restraining arms is to restrain inadvertent rotation in either direction of either the inner wheel 11 or the annular outer wheel 12 other than when the components are being actively driven on actuation of the dispensing container 3 as will be described below. In other words, the action of the flexible restraining arms helps to prevent actuation of the dose indicator device 9 if the device is dropped, shaken or knocked. [0077] In operation, as is normal for a pressurised metered dose inhaler, the dispensing container 3 is depressed relative to the housing 2 such that the canister 4 moves downwardly within tubular body 7 towards the stem block 8 to actuate the valve. [0078] On actuation of dispensing container 3 , downward movement of the canister 4 and valve 5 within the tubular body 7 causes the actuator member 13 to be moved downwardly within the tubular body 7 so as to compress spring 15 due to contact between the yoke 41 and the ferrule. At the same time, the legs 42 and thus the actuator drive arm 45 are moved downwardly relative to the C-shaped channel 80 and the inner wheel 11 . This brings the distal end of the actuator drive arm 45 into contact with one of the primary indexing teeth 22 and onward movement of the actuator arm 45 causes the inner wheel 11 to be rotated by one increment. Rotation of the inner wheel 11 is accommodated by radially-outward flexing of the first flexible restraining arm 57 such that the circular formation at the distal end of the first flexible restraining arm 57 is displaced from its initial indentation 24 and then re-engages into a neighbouring indentation 24 associated with a neighbouring primary indexing tooth 22 to that being engaged by the actuator drive arm 45 . During rotation of the inner wheel 11 the pin 23 b moves around the annular gap between the teeth 33 of the annular outer wheel 12 and the rim 52 of the cup-shaped housing 70 . This movement of the pin 23 b does not interact with the teeth 33 until contact with the deflector 59 as described below. [0079] On release of the dispensing container 3 , the dispensing container 3 moves back upwardly within the tubular body 7 under the internal spring bias of the valve 5 . This upward movement allows the actuator member 13 to move back upwardly within tubular body 7 under action of spring 15 . This causes in turn the legs 42 and yoke 41 to move back upwardly relative to the inner wheel 11 back into the at rest position. Depending on the number of primary indexing teeth 22 and their relative spacing, this upward movement may be accommodated by the actuator drive arm 45 flexing and riding back over the neighbouring primary indexing tooth 22 . In such a situation, the engagement of the first flexible restraining arm 57 in the indentation 24 prevents any back rotation of the inner wheel 11 . [0080] Thus, on each actuation of the dispensing container 3 , the inner wheel 11 is rotated by one increment. Successive actuations of the dispensing container 3 continue to rotate the inner wheel 11 until the point that the pin 23 b moves round into engagement with the deflector 59 . At this point, on actuation of the dispensing container 3 , the inner wheel 11 is rotated as described above and at the same time the pin 23 b is deflected radially inwardly into engagement with one of the teeth 33 of the annular outer ring such that the annular outer wheel 12 is rotated by one increment. Advantageously, no transmission cog is required to transfer the motive force from the inner wheel 11 to the annular outer wheel 12 . As with the movement of the inner wheel 11 , the rotation of the annular outer wheel 12 is accommodated by radially-outward flexing of the second flexible restraining arm 55 to move the circular formation at the distal end of the second flexible restraining arm from its tooth 33 on to a neighbouring tooth 33 . Both the inner wheel 11 and the annular outer wheel 12 rotate in the same sense, which may be designed to be either clockwise or anti-clockwise. [0081] In this way, reciprocal longitudinal movement of the dispensing container 3 can be used to create rotational movement of the inner wheel 11 and the annular outer wheel 12 to change display of dosage indicia provided on the inner wheel 11 and or annular outer wheel 12 . [0082] At the end of life of the pack the rotation of the inner wheel 11 will bring the pin 23 b into contact with the land 33 a of the annular outer wheel 12 . At this point further rotation of the annular outer wheel 12 is prevented since the pin 23 b is unable to engage with a tooth 33 to rotate the annular outer wheel 12 . [0083] When not in use the dust cap 106 can be placed on the mouthpiece 6 . The tang 161 projects through the lock-out aperture 61 to prevent actuation of the counter by contacting and blocking downward movement of the yoke 41 . [0084] FIGS. 10 to 12 show another embodiment of pressurised metered dose inhaler 1 according to the present disclosure. The structure and function of this embodiment is similar to that of the embodiment of FIGS. 1 to 9 and in the following only the differences will be described in detail. Equivalent features have been referenced using equivalent reference numerals. [0085] The tubular body 7 of the actuator housing 2 of this embodiment is formed from two mouldings comprising a top case 117 a and a bottom case 117 b . The bottom case 117 b fully defines the mouthpiece 6 , the stem block 8 and the base 7 d of the actuator housing. In addition, the C-section channel 80 and the tubular extension 10 form part of the bottom case 117 b . As can be seen in FIG. 12 , the bottom case 117 b fully houses the dose indicator device 9 . The top case 117 a in this embodiment shields the majority of the body of the pressurised dispensing container 3 . The top case 117 a may be formed from a transparent or translucent material to allow markings or writing on the pressurised dispensing container 3 to be read without the need to remove the container from the actuator housing 2 . [0086] The top and bottom cases 117 a , 117 b may be snap-fit together by means of formations on each casing. [0087] As before, the pressurised dispensing container 3 is inserted into the actuator housing 2 through the open upper end 7 f —in this embodiment fully defined by the top case 117 a. [0088] Operation of the pressurised metered dose inhaler 1 , including actuation of the dose indicator device 9 is the same as in the previous embodiment.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention This invention is in the field of tennis rackets made up of essentially two channel-shaped members which have interengaging portions within their geometrics so that they can be received in tight interengaging relationship. 2. Description of the Prior Art All are familiar with the conventional tennis rackets which for years have been made of wood and provided with gut or nylon strings. The playing characteristics of such wood rackets, however, unavoidably vary because of differences in the character of the wood, humidity and age. Such changes may tend to cause the head of the racket to warp due to variations in string tension. The prior art is also replete with suggestions relating to steel and aluminum tennis rackets which do not have some of the noted disadvantages of the wood rackets but they are nevertheless difficult to fabricate and quite expensive. The prior art also contains numerous disclosures, some of them quite incidental, dealing with the use of synthetic resins as materials for tennis racket manufacture, either alone or in combination with metal. The following discussion refers to some of such prior art disclosures but is meant to be illustrative only and is certainly not exhaustive. In the late 1920's Robinson in his U.S. Pat. No. 1,636,867 disclosed a tennis racket which included a truss-type structure which could be utilized alone or embedded in a suitable material such as a "Bakelite" thermosetting resin. Panker U.S. Pat. No. 1,954,327 which issued in 1934 referred to a method of making tennis rackets by embedding a previously tightly stretched network in a frame consisting of a material which during embedding was rendered plastic and which hardened after being shaped to the desired shape to secure the strings firmly in position. Hatton U.S. Pat. No. 2,274,788 issued in 1942 described a composite tennis racket in which a central metal tube was encased in a suitable plastic material such as a cellulose base material or a thermosetting resin. Robinson U.S. Pat. No. 2,593,714 issued in 1952, describes in connection with FIG. 170 a method for manufacturing a tennnis racket in which plastic tubes are inserted into a prepared mold, utilizing tapered insert pins inserted between the opposed plastic tubes to form the stringing holes. In more recent times, Eshbaugh in U.S. Pat. No. 3,483,055 which issued in 1969 described a method of producing tennis racket frames from flexible winding materials which involved the winding of such winding materials about a suitable form and then heat curing the materials to a rigid condition while under pressure. Howe U.S. Pat. No. 3,690,658 described a tennis racket construction having a central dampening core sandwiched between skins of high strength material which served as the racket faces. The bow portion of the racket had at least one web having higher strength characteristics than the core, and extending normal to the skins, Layers of elastomeric material were utilized between the skins and the core to assist in laminating the core, skins and web into a unitary structure. Erwin et al. U.S. Pat. No. 3,755,037 which issued in 1973 described a racket composed of a head portion and a handle portion integrally formed by a tubular member composed of helically wound fibers of high tensile strength embedded in a hardened binder having a preformed reinforcing member defining the base of the oval head portion and bounded on opposite sides to the tubular member, the handle portion being defined in part by generally parallel extending portions of the tubular member surrounded by a grip. The racket was produced by helically winding high strength fibers around the core, removing the core and finally hardening the binder. Regardless of the method employed for making tennis rackets from synthetic resinous materials, the punching and drilling of string holes in volume production is quite an expensive procedure because of the costs of the tooling and the drilling time required. To our knowledge, no one had successfully molded in holes into a synthetic resin frame because of the complexity required in the mold. The present invention overcomes the difficulty of the prior art and provides a tennis racket frame utilizing readily moldable parts having generally uniform wall thicknesses, the geometry of the parts being such that they can be identical in cross-section and by inverting one part with respect to the other, the various ribs and walls are made to engage with each other into firm integrated relationship. SUMMARY OF THE INVENTION The present invention provides a tennis racket frame comprising a pair of channel-shaped members, the two channel-shaped members preferably having identical cross-sectional configurations so that all of the members can be made from a single mold. Each channel-shaped member preferably has a marginal rib, a first upstanding wall portion spaced from the marginal rib by a first groove, a second upstanding wall portion adjacent the other marginal edge of the member, and a second groove inwardly of the second wall portion. In a particularly preferred form of the present invention, we provide a tennis racket frame in which each of the channel-shaped members has a flat base portion, a marginal rib of equal or greater thickness than the base portion at each marginal edge thereof, the marginal ribs having depending portions defining a flat recessed portion at the underside of the base portion, a first wall extending perpendicular to the base portion and spaced from one of said marginal ribs by a distance slightly less than the width of the first wall, a second wall extending from the base portion in parallel spaced relation to the first wall, the second wall having a width and height dimension the same as those of the first wall, and means extending from the base portion to define a groove inwardly of the second wall and having a width slightly less than that of one of the walls. The channel-shaped members are interengaged with one channel member being in inverted relation with respect to the other, one wall of one channel member being received between the marginal rib and a wall of the other channel member, and the other wall of the channel member being bottomed in the aforementioned groove. Each of the walls of the channel members may have a tapered end portion to facilitate wedge locking engagement between the two channel members. Each of the channel-shaped members is provided with slots therein which are arranged to be aligned with slots in the other channel member so that the slots when in registry define string holes for the frame. The rackets of the present invention may also be provided with facing strips on both faces thereof for purposes of increasing the stiffness and strength. BRIEF DESCRIPTION OF THE DRAWINGS Other objects, features and advantages of the invention will be readily apparent from the following description of certain preferred embodiments thereof, taken in conjunction with the accompanying drawings, although variations and modifications may be effected without departing from the spirit and scope of the novel concepts of the disclosure, and in which: FIG. 1 is a plan view of a tennis racket produced according to the present invention; FIG. 2 is an enlarged cross-sectional view taken substantially along the line II--II of FIG. 1; FIG. 3 is a plan view of one of the two channel members before the two members are assembled into interengaging relationship to form the finished racket; FIG. 4 is an enlarged cross-sectional view of the handle portion taken substantially along the line IV--IV of FIG. 1; FIG. 5 is an enlarged elevational view illustrating the manner in which the slots in the two interengaging channel members cooperate to define stringing holes; and FIG. 6 is an enlarged cross-sectional view taken substantially along the line VI--VI of FIG. 5. DESCRIPTION OF THE PREFERRED EMBODIMENTS In FIG. 1, reference numeral 10 indicates generally a tennis racket produced according to the present invention and including a head portion 11, a throat portion 12 and a handle portion 13. The head of the racket is provided with the usual strings 14 extending along and across the oval-shaped head portion 11. Turning now to FIGS. 2 and 3 it will be seen that the tennis racket of the present invention involves the interengagement of two channel-shaped members generally identified at reference numerals 15 and 16, respectively. For convenience, since the two channel members 15 and 16 are identical in cross-sectional configuration, corresponding portions of these two channel members will be given the same subscripts. Thus, the channel-shaped member 15 has a flat portion 15a while the channel-shaped member 16 has a similar flat base portion 16a. The channel-shaped member 15 is provided with a marginal rib 15b at one marginal edge thereof and a second marginal rib 15c along its other marginal edge. The ribs 15b and 15c have a thickness equal to or greater than the thickness of the flat base portion 15a. Similarly, the channel member 16 has corresponding marginal rib portions 16b and 16c. The marginal rib portions 15b and 15c (as well as rib portions 16b and 16c) are formed with flat recessed portions 15d and 16d, respectively, for receiving flat facing strips 17 and 18. These facing strips may be strips of synthetic resin containing steel, fiberglas, graphite, aluminum, titanium, boron, or other high modulus fibers, or they may be strips of high strength, high modulus metals which add stiffness and strength to the frame assembly. The channel-shaped members themselves may be made of a reinforced plastic material such as a nylon which is reinforced with short fibers of glass, steel, aluminum or other stiff material. While the use of facing strips 17 and 18 will be desirable in most instances, they may not be required if the body of the channel members is composed of an exceptionally strong composite material such as one containing "Kevlar 49" which is the Du Pont Company's trademark for its lightweight, high strength, high modulus organic reinforcing fibers contained in an epoxy or polyester matrix. The channel-shaped member 15 includes a first wall 15e which is spaced from the marginal rib 15c by a distance slightly less than the width of the wall 15e. Similarly, a wall 16e extends perpendicular to the flat base portion 16a of the channel member 16. A second wall 15f extends perpendicular to the base portion 15a in generally parallel spaced relation to the wall 15e, the second wall 15f having a width and height dimension the same as those of the first wall 15e. The corresponding wall portion on channel member 16 has been identified at reference numeral 16f. An angular rib 15g is provided on the base portion 15a in spaced relation to the wall portion 15f to define a groove therein inwardly of the wall 15f, the groove having a width slightly less than the width of the wall 15e or 15f. The channel member 16 is provided with a corresponding rib 16g, as shown in FIG. 2. The walls 15e and 15f as well as walls 16e and 16f are provided with tapered end portions such as those indicated at 15h and 16h, respectively, to facilitate a wedge locking engagement between the two sections when they are mated in the position shown in FIG. 2 of the drawings. In other words, the wall 16f is fitted in wedged engagement in the groove which exists between the wall 15e and the rib 15c and the wall 15e has a tapered end portion 15h which facilitates wedge locking engagement in the groove provided between the rib 16g and the wall 16f. The same is true, of course, in the opposite side where the wall 16e is received in wedged engagement between the rib 15g and the rib 15b and the wall 15f is likewise received in the groove provided between the web 16c and the wall 16e. Turning next to FIG. 3, it will be seen that the walls 15e and 15f cooperate to define the oval string-receiving head portion of the racket and their extremities define the handle portion of the racket. At the throat portion of the racket, there may be provided additional brace members 15i, 15j, 15k and 15l which cooperate with corresponding base members on the channel-shaped member 16 to provide additional rigidity in the throat section. The channel-shaped member 15 may also include a centrally extending wall 15m in that portion of the channel-shaped member which extends from the throat of the racket through the handle portion, as best illustrated in FIG. 4. The wall 15m is received in a groove provided by an angular rib 16n which is spaced from the corresponding centrally disposed wall 16m of the channel section 16. The end portion of the wall 16m is, in turn, received in the groove provided between the wall 15m and an angular rib 15n formed in the base portion of the channel member 15. The manner in which the string holes are provided is best illustrated in FIGS. 5 and 6 of the drawings. As there illustrated, the wall member 15e (as well as the wall member 16e) is provided with a series of spaced slots 15o which are arranged to be aligned with correspondingly shaped slots 16o provided in the wall 16f and thereby defining a plurality of spaced string apertures 19 as best seen in FIGS. 5 and 6. As best seen in FIG. 6, the apertures 19 which extend between the abutting walls 15b and 16e are aligned with the apertures 19 which extend between the abutting walls 15e and 16f. It should also be noted that the walls in the vicinity of the slots 15o and 16o can be rounded off to give a relatively wide radius (a 1/16 inch or so) to avoid any sharp edges at the string hole areas. The extremity of the slot 16o, identified at 16p, may be provided with a double wall thickness to create a flush face at the resulting hole when the two sections are mated. The channel members 15 and 16 are assembled as shown in FIGS. 2 and 4 and may be secured together with a suitable adhesive or otherwise secured together. Then, the handle portion 13 may be provided in the usual manner, as by applying a pair of pallets to the frame structure and winding a layer of leather over the assembled pallets. The tennis racket assembly of the present invention has unique advantages as compared with other tennis racket assemblies composed of plastic materials. For one, the two channel sections are readily moldable in a single mold. The string holes are achieved without drilling as a natural result of the geometry employed. Furthermore, the cross-section of the channels can be shaped to create string protection channels. The mating sections are also such that it is virtually impossible to detect that the frame is made of two sections. It should be evident that various modifications can be made to the described embodiments without departing from the scope of the present invention.

1a

PRIORITY STATEMENT This application claims benefit of priority under 35 U.S.C. §119 from Swedish Patent Application No. 0602185-1 filed on Oct. 18, 2006, in the Swedish Patent Office, the disclosure of which is incorporated herein by reference in its entirety. FIELD OF THE INVENTION The present invention relates to the field of animal arrangements and in particular to a method for cleaning a gripper device of a milking station, and to a milking system for effectuating the cleaning method. BACKGROUND OF THE INVENTION Apparatuses for automatically milking animals are well known and have a widespread use. The milking apparatuses comprise various mechanical movable parts for implementing the automation. For example, a milking robot comprises a robot arm for automatically gripping teat cups and for attaching them to the teats of a milking animal, such as a cow. The environments in which the milking apparatuses are arranged, for example cowsheds, are often dirty and dusty. This imposes strains on the mechanical parts of the automatic milking systems in that their proper functioning may be detrimentally affected or even halted by dirt entering into openings in the housings of the mechanical parts. A stoppage within a milking farm is very undesired since it not only imposes costs for the farmer, but may also be harmful and painful for the milking animals. Gripping devices of the type that encloses the teat cups in order to grip hold of them, for example claw like grippers, have several movable parts prone to wear. Further, the movable parts of such gripper devices comprise a housing and joints having a number of openings into which dirt and dust may penetrate and detrimentally affect their performance. From the above it is clear that the stresses put on the mechanical parts of the milking system, for example by dirt, should be kept at a minimum in order to obtain a secure and reliable operation. The mechanical parts are therefore advantageously cleansed regularly in order to function properly. A farmer then typically inspects the milking station manually and washes off each milking station separately if required. It is clear that such cleaning may be cumbersome and time-consuming considering the number of openings in the various mechanical parts of each milking station. It is most desirable that cleaning procedures within a milking farm are efficient and easy to perform. SUMMARY OF THE INVENTION In contrast to the above-described claw type of gripper devices electromagnetic gripper devices generally do not have as many movable parts or open spaces in which dust and the like may gather. An example of electromagnetic gripper devices is disclosed in the International Application WO 2005/122753, assigned to the same applicant as the present application. The electromagnetic gripper devices in the above-mentioned document do not have any movable parts and are each made in one piece. Thereby the gripper devices lack openings into which dust and dirt may enter. All gripper devices manufactured may further be identical to each other, i.e. they need not be adapted for use at a particular side of the animals being milked. Although the electromagnetic gripper devices described above have advantages compared to traditional gripping claws, they will still need to be cleansed. The gripper device has to be capable of gripping and holding teat cups firmly and also to withstand forces exerted on the teat cups while being moved in the usage. If the electromagnet of the gripper device is dirty its grip on the teat cup will inevitably be poorer. It is therefore an object of the invention to provide cleaning means for cleaning gripper devices, and in particular for cleaning electromagnetic gripper devices. It is another object of the present invention to provide means for enabling an efficient and reliable cleaning of gripper devices, which do not require cumbersome and time-consuming cleaning steps. It is yet another object of the present invention to provide means for enabling a cost-efficient and simple cleaning of gripper devices. In accordance with the invention, a method for cleaning a gripping device of a milking station for milking animals is provided. The method comprises the steps of initiating a gripper device cleaning procedure; moving the gripper device to a cleaning position; and carrying out the gripper device cleaning procedure. Further, the invention is easily implemented in already existing and utilized milking stations, with only minor changes. The present invention thus provides a cost-efficient way to perform the cleaning, since existing cleaning steps may be utilized. In an embodiment of the invention, the gripping device is arranged on or is a part of a robot arm. This embodiment of the invention provides a cost-efficient way to perform the cleaning, wherein the movement ability of the robot arm holding a gripper device can be utilised. That is, an existing robot arm is able to perform movements in order to fetch teat cups, and a similar movement may be utilised for cleaning the gripper device arranged on the robot arm. Further, the gripper device may be arranged on any handling device for handling teat cups and the like, which handling device is manually moved or computer-controlled. In accordance with an embodiment of the invention, the step of initiating the gripper device cleaning procedure is performed when a milking occasion is completed or at regular intervals or when a failure to grip the teat cup is detected. The initiation can be performed at any suitable triggering occurrence or event and a flexible cleaning of the gripper device is thereby provided. The cleaning can be customized to suit the particular user and the particular milking plant. In accordance with another embodiment of the invention, the method further comprises the step of moving the gripper device back to an idle position upon completion of the gripper device cleaning procedure. If the gripper device is arranged on a robot arm, then the robot arm is moved to an idle position upon completion of the cleaning process. The robot arm and/or gripper device is thereby always ready for a subsequent operation and the efficiency of a milking system is increased. In accordance with still another embodiment of the invention, the method comprises the further step of determining a degree of soil on a surface of the gripper device. If it is determined that the gripper device is too soiled to function properly, the cleaning procedure may be initiated. A most reliable functioning of the gripper device can thereby be obtained, wherein the gripper device always provides a firm grip of the teat cup or the like. In accordance with yet another embodiment of the invention, the step of carrying out the gripper device cleaning procedure comprises rubbing the gripper device against a sponge. In an alternative embodiment the gripper device cleaning procedure comprises spraying cleaning agent on the surface of the gripper device. In a further yet embodiment, the gripper device cleaning procedure comprises blowing air on the surface of the gripper device. The cleaning procedure can thereby be made very flexible to suit the needs of the specific user. The invention also relates to a milking station comprising cleaning means for cleaning the gripper device, whereby advantages similar to the above are achieved. Further characteristics of the invention and advantages thereof will be evident from the following detailed description of preferred embodiments of the present invention given hereinafter and the accompanying figures, which are given by way of illustration only, and shall thus not be construed as limitative of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 illustrates a milking robot of a milking system comprising the cleaning means in accordance with the present invention. FIG. 2 illustrates the method for cleaning a gripper device in accordance with the present invention. DETAILED DESCRIPTION OF EMBODIMENTS A milking system or milking station 1 for voluntary milking comprising cleaning means in accordance with the invention is illustrated in FIG. 1 . An automatic milking machine (not illustrated in detail) is provided for milking animals, such as for example cows. The automatic milking machine comprises teat cups 2 connected to an end unit by means of milk lines (only small portions of which attached to the teat cups are shown in the figure). A milking robot or other automatic handling device 3 having a handling device, such as a robot arm 4 , equipped with a gripper device 5 in its far end is provided for automatically fetching the teat cups 2 of the milking machine from a rack 6 , in which the teat cups 2 are stored. The robot arm 4 moves the teat cups 2 toward the udder of the cow and attaches them to the teats of the cow. The teat cups 2 may be fetched, moved and attached one at a time or several at a time. The milking robot 3 is typically equipped with a camera system or other detecting device 7 for determining the exact positions of the teats to which the teat cups 2 are to be attached. The gripper device 5 is intended to grip, to hold and to release the teat cups 2 or other equipment, such as for example a teat-cleaning cup 11 . The milking station 1 may comprise other conventionally used devices, not shown or described in detail herein. For example, teat-treatment devices may be provided, identification members for identifying a cow etc. The milking station 1 further comprises a control unit 8 , which is responsible for controlling the milking station 1 . Processing within the control unit 8 comprise, inter alia, initiation of various activities in connection with the milking such as opening and closing of gates, controlling of the automatic milking machine and the milking robot 3 . The control unit 8 typically comprise a microcomputer, suitable software and a database including information of each of the cows being milked by the automatic milking machine, such as for example when a specific cow was last milked or last fed, or her milk production, her health etc. In accordance with the invention, means are provided for enabling efficient cleaning of the gripper device 5 . In one embodiment of the invention, the means comprise a cleaning device 9 having a suitable cleaning member 10 . The cleaning member 10 may for example comprise spray means for spraying cleaning agents on the gripper device 5 , or blowing means for blowing air, preferably compressed air, onto the gripper device 5 and thereby cleaning it. Other types of cleaning members are conceivable as well. In a particular embodiment the cleaning member 10 is a sponge or the like. The cleaning is then effectuated by removing dirt off the gripper device 5 by rubbing it against the sponge. The cleaning member 10 of the cleaning device 9 is then a suitable sponge. The use of a sponge provides a cost-efficient solution, with low energy consumption and low purchase costs. Further, the sponge is easily replaced when need arises. The robot arm 4 comprising the gripper device 5 is moved towards the cleaning device 9 upon initiation of a gripper device cleaning procedure. The gripper device 5 of the robot arm 4 is thereby moved to a cleaning position (indicated by dashed lines in the figure) in which the cleaning can be performed. In case the cleaning member 10 is a sponge, the robot arm 4 is preferably arranged to move back and forth in front of the sponge a number of times in order to rub the gripper device 5 against it. Upon finishing the cleaning of the gripper device 5 , the robot arm 4 is returned to a non-active or an idle position. The robot arm 4 is then ready for a subsequent operation, such as fetching teat cups 2 or the like. For ease of illustration, the cleaning device 9 is shown as a separate unit in the figure. However, the cleaning device 9 is preferably integrated with the milking station 1 in any suitable manner, for example constituting part of or being arranged on the enclosure of the milking station 1 . The cleaning device may be arranged on a part of the milking robot 3 . The only requirement is that the cleaning device 9 is placed so as to be within reach of the gripper device 5 of the robot arm 4 . The control unit 8 comprises software for effectuating the cleaning procedure in accordance with the invention. The cleaning procedure for cleaning the gripper device 5 may be programmed and customized to suit the needs of the specific farm in which it is utilized. The cleaning may, for example, be performed after each cow that has been milked, after every fifth or tenth milked cow, a certain number of times an hour or whatever frequency is most appropriate for the particular milking farm. The frequency may depend on various factors, such as the number of cows (the environment may be more soiled the more cows are being kept), the water quality, the sensitivity of the gripper device and so on. The frequency with which to cleanse the gripper device 5 can be set by the user and is easily changed should such need arise. The suitable cleaning frequency is programmed into the control unit 8 . There are means for transmitting signals from the control unit 8 to the milking robot 3 , for initiation of the gripper device cleaning procedure. That is, the control unit 8 comprises means, such as software, for initiating the gripper device cleaning procedure. However, the gripper device 5 may comprise means for transmitting signals to the control unit 8 as well. For example, the gripper device 5 may include sensing means for sensing if the surface of the gripper device 5 is too soiled to function properly and transmit an indication to the control unit 8 about this. Such sensing of a soiled surface may be implemented by means of a camera and a laser source emitting laser light. The detecting device 7 described earlier may be utilised in this sensing of a soiled surface. The camera is provided to register laser light as reflected from the gripper device 5 and to thereby enable a determination of whether the surface of the gripper device 5 is soiled. The gripper device 5 may comprise an optical sensor for this end, which optical sensor presumably is as soiled as the gripper device surface in which it is arranged. Alternatively, inductive sensors may be provided in the gripper device 5 for sensing a magnetic field or an inductance or a change thereof as caused by the gripper device surface being soiled. A video camera or CCD-camera may be utilised for the above sensing of a soiled surface. Such camera may be fixedly arranged to take images of the gripper device 5 in the idle position, and the control unit 8 may then comprise means for processing the images or evaluating the need of cleansing in dependence on the amount of reflected light. The cleaning may also be initiated if the gripper device 5 fails to grip hold of a teat cup. Sensing means for sensing such failure is then included within the gripper device 5 . Such sensing means are disclosed in a patent application entitled “Detecting arrangement and method for a magnetic gripper device”, filed on Sep. 2, 2005, assigned to the same applicant as the present application. The control unit 8 may be programmed to initiate the cleaning procedure of the gripper device 5 in case of such teat attachment failure. Further, the sensing means may also detect if the performance of the gripper device 5 is deteriorating, that is, the gripper device 5 may still be capable of holding a teat cup 2 but the grip is deteriorating. The gripper device 5 is then cleaned before a failure occurs. Typically, when a teat attachment step fails, the control unit 8 of the milking machine starts a fault-localizing test. Such fault-localizing tests require rather long periods of time in order to be performed, typically about 10-15 minutes, during which no milking can be done. In contrast, the cleaning step in accordance with the invention may be accomplished within about 5-10 s. Therefore, should the teat attachment procedure fail, cleaning of the gripper device 5 is a fast way to eliminate the possibility of the gripper device 5 being too dirty as the cause to the failure, or a fast way to obtain a successful teat attachment in case the reason for the failure is indeed that the gripper device 5 is too dirty. The detecting device 7 , for example a camera, for determining the exact positions of the teats may need cleaning as well. The detecting device 7 is preferably cleansed regularly in order to not reduce its performance. The cleaning of the detecting device 7 may, for example, be performed by moving the robot arm 4 comprising the detecting device 7 to a cleaning position. In an embodiment of the invention, the same cleaning device is utilised for cleaning the gripper device 5 . Since the cleaning of the gripper device 5 is performed in a similar manner or even by utilising the same cleaning means as is used for cleaning the detecting device 7 , a most cost-efficient cleaning of gripper devices is provided. In an embodiment of the invention, the cleaning of the gripper device 5 is performed each time cleaning of the detecting device 7 is effectuated. In particular, the cleaning device 9 may be adapted to accomplish simultaneous cleaning of the detecting device 7 and the gripper device 5 . The cleaning device 9 may comprise different cleaning members for the gripper device 5 and the detecting device 7 , respectively. The different cleaning members may then be arranged so as to allow simultaneous cleaning to be performed. The invention is also related to a corresponding method, illustrated in FIG. 2 . The method 20 for cleaning the gripping device 5 arranged on the robot arm 4 of the milking station 1 is initiated in step 21 . The initiation may be triggered, for example, at completion of a milking occasion or at a detected failure to grip the teat cup 2 as described above. The initiation may be triggered by other means as well. In step 22 the robot arm 4 comprising the gripper device 5 is moved to a cleaning position. In the cleaning position, the robot arm 4 is in close proximity of the cleaning device 9 comprising the cleaning member 10 . Finally, in step 23 , the cleaning of the gripper device 5 is carried out. The gripper device cleaning procedure may comprise any suitable ways of cleaning the gripper device 5 . For example, the gripper device cleaning procedure may comprise rubbing the gripper device 5 against a sponge, or spraying cleaning agents on the surface of the gripper device, or even a combination of the described different cleaning procedures. In the cleaning position, a detecting device 7 of the milking station 1 can also be cleaned. Such step of cleaning the detecting device 7 can be effectuated before or after the cleaning of the gripper device 5 . Upon completion of the gripper device cleaning procedure, the robot arm 4 may be moved to an idle position, in which the robot arm 4 is ready for a subsequent operation, such as a teat attachment procedure. The gripper device 5 is preferably an electromagnetic gripper device, but any other type of gripper device may benefit from the present invention. Since electromagnetic gripper devices do not have any movable parts or open spaces wherein dirt may gather, they are particularly suitable for being cleansed by means of the invention. In the above description a milking station has been described in connection with an automatic milking system, and in particular a milking station for voluntary milking. However, the present invention may be utilised in other milking environments as well, for example in a not fully automated milking environment. For the purposes of the present invention, a milking station can be any area in which a milking animal is being milked, that is, an area arranged to house at least one animal for milking. The present invention can be implemented in any type of milking stall, for example a parallel stall arrangement or a rotary milking parlour. The term “milking station” is thus intended to encompass different types of milking stations. Similarly, throughout the above description the term “robot arm” has been utilised. However, the term robot arm has been used in an illustrative embodiment of the invention, in which the term robot arm is generally used to denote a part of a milking robot. In the above description, the term “robot arm” could be exchanged to “handling device”. The handling device is intended to denote a handling device for handling teat cups and other milking related equipment. In accordance with the invention, such handling device may be the described robot arm of a milking robot, but it may alternatively be a supporting arm or service arm that can be moved in a computer-controlled manner, semi-manually or manually to a cleaning position. In summary, the present invention provides an efficient cleaning of gripper devices. The farmer is alleviated from the task of manually inspecting the gripper devices and wash them upon need. Further, by regularly cleaning the gripper device the operation of the milking station is ensured and the gripper device provides at all times a firm and reliable grip of the teat cups. While the present invention has been described in various embodiments it shall be appreciated that the invention is not limited to the specific features and details set forth, but is defined only by the appended patent claims.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This patent application claims priority to and the benefit of and is a continuation-in-part of U.S. Provisional Patent Application Ser. No. 61/062,448 entitled “Dilator” filed on Jan. 23, 2008 which is incorporated herein by reference in its entirety. This application also claims priority to and is a continuation-in-part of U.S. patent application Ser. No. 11/582,874 entitled “Minimally invasive tooling for delivery of interspinous spacer” filed on Oct. 18, 2006 which is incorporated herein by reference in its entirety. BACKGROUND [0002] A variety of retractors and dilation systems have been used to provide a traditional “open” or “mini-open” approach to the posterior spine, as well as for providing the more modern “minimally invasive” and “percutaneous” access to the spine. The “open” or “mini-open” approaches to the spine typically require larger incisions. These larger incisions readily provide visual and instrument access to the surgical site; however, larger incisions generally result in greater damage to muscle tissue, blood loss, long healing times accompanied by prolonged pain and significant scarring. [0003] The development of minimally invasive, percutaneous procedures has provided a major improvement in reducing recovery time and post operative-pain. In minimally invasive, percutaneous techniques patient trauma is minimized by creating a relatively smaller incision, followed by the introduction of a series of successfully larger dilators installed in sequence to dilate the soft tissues and increase the effective size of the incision. In some cases, a guide wire is used to first access the surgical site and then cannulated dilators are installed over the wire. Following installation of the largest dilator deemed necessary, a cannula or retractor is advanced over the largest dilator for providing a working channel from the skin of the patient to the working space adjacent to the spine. Surgery is performed or an implant is inserted through a surgical port or cannula inserted into the dilated incision. [0004] Instead of cutting a larger opening, sequential dilation splits the surrounding tissue to create a larger opening. Splitting the muscle fibers apart, rather than cutting the muscle causes less damage to the tissue and leads to faster recovery times and reduced patient discomfort. Also, sequential dilation provides an advantage in that it allows the surgeon to make an initially small incision, then gradually increase the size of the opening to the minimum size required for performing the surgical procedure, thus reducing tissue damage and speeding patient recovery time. [0005] Certain spinal procedures, such as those developed by VertiFlex, Inc. and described in U.S. patent application Ser. No. 11/314,712 entitled “Systems and methods for posterior dynamic stabilization of the spine” filed on Dec. 20, 2005 and U.S. patent application Ser. No. 11/582,874 entitled “Minimally invasive tooling for delivery of interspinous spacer” filed on Oct. 18, 2006 and U.S. patent application Ser. No. 11/593,995 entitled “Systems and methods for posterior dynamic stabilization of the spine” filed on Nov. 7, 2006, U.S. patent application Ser. No. 12/148,104 entitled “Interspinous spacer” filed on Apr. 16, 2008, U.S. patent application Ser. No. 12/217,662 entitled “Interspinous spacer” filed on Jul. 8, 2008, U.S. patent application Ser. No. 12/220,427 entitled “Interspinous spacer” filed on Jul. 24, 2008, U.S. patent application Ser. No. 12/205,511 entitled “Interspinous spacer” filed on Sep. 5, 2008, U.S. patent application Ser. No. 12/338,793 entitled “Interspinous spacer” filed on Dec. 18, 2008, U.S. patent application Ser. No. 12/354,517 entitled “Interspinous spacer” filed on Jan. 15, 2009, all of which are incorporated herein by reference in their entireties, access the surgical site through tissue and through the supraspinous ligament, for example, for the insertion of a device, such as an interspinous spacer. Whereas the procedure may be performed in an open, mini-open or minimally invasive, percutaneous approach, penetrating the supraspinous ligament can be challenging as the ligamentous tissue is not only strong but also slippery. However, penetrating the supraspinous ligament particularly lends itself well to sequential dilation as the ligament is formed of a cord of substantially uniformly oriented fibrous strands that are advantageously capable of being split apart rather than transversely cut for minimizing trauma and increasing patient recovery time. Furthermore, approaching the interspinous process space through the supraspinous ligament, like the VertiFlex device, advantageously avoids the multifidus muscle and thereby preserves its critical function as a stabilizer of the lumbar spine. Because of the difficulties associated with penetrating ligament, there is a special need for a dilator and/or dilator system designed for accessing a surgical site through ligament such as the supraspinous or interspinous ligament. The current invention provides a dilator and dilator system for establishing an opening through ligament that may also be used in conjunction with minimally invasive, percutaneous procedures. SUMMARY [0006] According to one aspect of the invention, a dilator comprising a proximal portion and a distal portion interconnected by an elongated body portion is provided. At least a part of the distal portion has a cross-sectional area decreasing with distance towards the distal end. Two oppositely located channels are formed in the body portion and extend longitudinally into the distal portion. [0007] A system comprising a dilator and a cannula is provided. The dilator comprises a proximal portion and a distal portion interconnected by an elongated body portion. At least a part of the distal portion has a cross-sectional area decreasing with distance towards the distal end. Two oppositely located channels are formed in the body portion and extend longitudinally into the distal portion. The cannula includes two oppositely located channels on the outer surface and has a passageway configured to receive the dilator. [0008] A method is provided comprising the steps of inserting a dilator into a patient via a posterior midline approach between two adjacent spinous processes and distracting the adjacent spinous processes by advancing the dilator relative to the adjacent spinous processes. BRIEF DESCRIPTION OF THE DRAWINGS [0009] FIG. 1 a is a side view of a dilator and an enlarged portion of the distal end of the dilator according to the present invention. [0010] FIG. 1 b is a top view of a dilator and an enlarged portion of the distal end of the dilator according to the present invention. [0011] FIG. 1 c is a perspective view of a distal end of a dilator according to the present invention. [0012] FIG. 1 d is an end view of a distal end of a dilator according to the present invention. [0013] FIG. 1 e is a cross-sectional view of the distal end of a dilator according to the present invention. [0014] FIG. 2 a is a side view of a dilator and an enlarged portion of the distal end of the dilator according to the present invention. [0015] FIG. 2 b is a top view of a dilator and an enlarged portion of the distal end of the dilator according to the present invention. [0016] FIG. 2 c is a perspective view of a distal end of a dilator according to the present invention. [0017] FIG. 2 d is an end view of a distal end of a dilator according to the present invention. [0018] FIG. 2 e is a cross-sectional view of the distal end of a dilator according to the present invention. [0019] FIG. 3 a is a side view of a dilator and an enlarged portion of the distal end of the dilator according to the present invention. [0020] FIG. 3 b is a top view of a dilator and an enlarged portion of the distal end of the dilator according to the present invention. [0021] FIG. 3 c is a perspective view of a distal end of a dilator according to the present invention. [0022] FIG. 3 d is an end view of a distal end of a dilator according to the present invention. [0023] FIG. 3 e is a cross-sectional view of the distal end of a dilator according to the present invention. [0024] FIG. 4 a is a side view of a dilator and an enlarged portion of the distal end of the dilator according to the present invention. [0025] FIG. 4 b is a top view of a dilator and an enlarged portion of the distal end of the dilator according to the present invention. [0026] FIG. 4 c is a perspective view of a distal end of a dilator according to the present invention. [0027] FIG. 4 d is an end view of a distal end of a dilator according to the present invention. [0028] FIG. 4 e is a cross-sectional view of the distal end of a dilator according to the present invention. [0029] FIG. 5 a is a side view of a dilator and an enlarged portion of the distal end of the dilator according to the present invention. [0030] FIG. 5 b is a top view of a dilator and an enlarged portion of the distal end of the dilator according to the present invention. [0031] FIG. 5 c is a perspective view of a distal end of a dilator according to the present invention. [0032] FIG. 5 d is an end view of a distal end of a dilator according to the present invention. [0033] FIG. 5 e is a cross-sectional view of the distal end of a dilator according to the present invention. [0034] FIG. 6 a is a side view of a dilator and an enlarged portion of the distal end of the dilator according to the present invention. [0035] FIG. 6 b is a top view of a dilator and an enlarged portion of the distal end of the dilator according to the present invention. [0036] FIG. 6 c is a perspective view of a distal end of a dilator according to the present invention. [0037] FIG. 6 d is an end view of a distal end of a dilator according to the present invention. [0038] FIG. 7 a is a side view of a dilator and an enlarged portion of the distal end of the dilator according to the present invention. [0039] FIG. 7 b is a top view of a dilator and an enlarged portion of the distal end of the dilator according to the present invention. [0040] FIG. 7 c is a perspective view of a distal end of a dilator according to the present invention. [0041] FIG. 7 d is an end view of a distal end of a dilator according to the present invention. [0042] FIG. 8 a is a side view of a cannula according to the present invention. [0043] FIG. 8 b is a perspective view of a distal end of a cannula according to the present invention. DETAILED DESCRIPTION [0044] While the description of the dilator system of this invention will be discussed primarily in relation to spinal surgery, it should be understood that the system will find use in other areas of surgery in which a surgeon wishes to gain access to an internal cavity by cutting the skin and enlarging an incision in a body wall so that surgical instruments can be inserted to perform a desired surgical procedure. For example, the dilator system may be used to create an incision to provide access to the posterior spine through which pedicle screws may be percutaneously installed in one or more selected vertebra. Alternatively, the dilator system may be used to create an incision to access an invertebral disc space for performance of a minimally invasive discectomy procedure and/or spinal fusion procedure including the implantation of one or more intervertebral or interspinous process implants. [0045] Implants are inserted between adjacent spinous processes to distract the spine segments and maintain them in a position to relieve symptoms of spinal stenosis and other conditions that cause pain which is associated with the back. Such implants have a spacer which remains in place between the adjacent spinous processes. An opening is created in the supraspinous and/or interspinous ligament so that the implant can be inserted. The dilators of the present invention are used to step dilate or gradually dilate body tissue, in particular, the supraspinous and/or interspinous ligament. [0046] The dilator system of the present invention includes one or more dilators configured to work independently or in conjunction with one another. When used in conjunction with one another a first dilator is generally smaller in outer diameter or cross-sectional area than that of a second dilator which typically is also cannulated so that the second dilator fits over the first dilator to dilate tissue. It should be noted that the second dilator, in one variation, is not cannulated but is sized larger than the first dilator. In such a variation, the first dilator is removed and the second dilator is inserted to expand body tissue. In another variation, the first dilator is cannulated to be placed over a guide wire that is first positioned in the patient. In any of the variations disclosed herein, the first dilator may also be cannulated. Although in some cases two dilators are discussed it should be noted that more than two dilators may be employed in any of the variations disclosed herein. Furthermore, some of the distal ends of the dilators of the present invention are sufficiently sharp or manufactured with integrated knife points to cut tissue without a need for a separate instrument such as a scalpel to create an initial incision in the skin or ligament which is then expanded with the dilators, whereas other dilators of the present invention have a distal end that is too blunt and a separate instrument such as a scalpel is employed to create the first incision in the tissue or ligament. [0047] With reference to FIG. 1 a , there is shown a dilator 10 according to the present invention. The dilator 10 has an elongated body 12 , a proximal end 14 and a distal end 16 . The dilator 10 includes a pair of channels 18 shown in FIGS. 1 b , 1 c and 1 e that are oppositely located from each other and run parallel to the longitudinal axis of the dilator 10 . The distal end 20 of the channel 18 commences in the distal end 16 and the proximal end 22 of the channel 18 ends in the body 12 portion of the dilator 10 . In one variation, the channel 18 has a flat base between two sidewalls. When inserted in a patient and aligned with the adjacent spinous processes, the channels 18 are advantageous for distracting the spinous processes apart as well as for keeping the dilator 10 in position between the spinous processes while being inserted especially in a “kissing” condition of the spine where the posterior tips of adjacent spinous processes are in close proximity, touch or “kiss”. In one variation, the channels 18 are absent from the dilator 10 . The distal end 16 of the dilator 10 is a tapered portion where the diameter or cross-sectional area is less than the diameter or cross-sectional area of the body portion 12 . In the embodiment shown in FIGS. 1 a - 1 e , the distal end 16 portion has a cone shape shown in FIG. 1 c . An end view of the distal end 16 is shown in FIG. 1 d illustrating the tip or point 24 of the cone or bore 24 in a cannulated version of the dilator. When a cross-section of the distal end 16 is taken at a location distal to the channels 18 and perpendicular to the longitudinal axis of the dilator 10 as shown in FIG. 1 e , the cross-sectional area 26 of the distal end 16 is circular in shape. The cone-shaped dilator of FIGS. 1 a - 1 e is generally employed as a first dilator 10 and may be cannulated for passing over a guide wire or if used as a subsequent dilator for passing over a previous dilator. The cone-shaped dilator 10 shown in FIG. 1 punctures ligament and passes through soft tissue easily and therefore, it can be used as a first dilator in a minimally invasive percutaneous procedure without the need to first create a cut with a separate sharp edge such as a scalpel. A sharper tip formed by a distal end 16 with a more acute angle θ (see FIG. 1 b ) will prevent the tip 24 from slipping off to the sides of the ligament. [0048] Turning now to FIGS. 2 a - 2 e , there is shown another variation of a dilator 10 according to the present invention wherein like reference numbers are used to describe like parts. Referring first to FIG. 2 a , the dilator 10 has an elongated body 12 , a proximal end 14 and a distal end 16 . The dilator 10 includes a pair of channels 18 shown in FIGS. 2 b , 2 c and 2 e that are oppositely located from each other and run parallel to the longitudinal axis of the dilator 10 . The distal end 20 of the channel 18 commences in the distal end 16 and the proximal end 22 of the channel 18 ends in the body 12 portion of the dilator 10 . When inserted in a patient and aligned with the adjacent spinous processes, the channels 18 are advantageous for distracting the spinous processes apart as well as for keeping the dilator 10 in position between adjacent spinous processes while being inserted especially in a “kissing” condition of the spine where the posterior tips of adjacent spinous processes are in close proximity, touch or “kiss”. In one variation, the channels 18 are absent from the dilator 10 . The distal end 16 of the dilator 10 is a tapered portion where the diameter or cross-sectional area is less than the diameter or cross-sectional area of the body portion 12 and decreases toward the distal end 16 . In the embodiment shown in FIGS. 2 a - 2 e , the distal end 16 portion has a wedge shape formed by two substantially flat faces 28 that angle towards each other at the distal end 16 and form a line or rectangular tip 24 shown in FIG. 2 d . An end view of the distal end 16 is shown in FIG. 2 d illustrating the line or rectangular tip 24 of the wedge. A cannulated variation of the dilator 10 is not shown but is within the scope of the present invention. When a cross-section of the distal end 16 is taken at a location distal to the channels 18 and perpendicular to the longitudinal axis of the dilator 10 as shown in FIG. 2 e , the cross-sectional area 26 of the distal end 16 is rectangular in shape. The wedge-shaped dilator of FIGS. 2 a - 2 e is generally employed as a first dilator 10 and may be cannulated for passing over a guide wire or if used as a subsequent dilator for passing over a previous dilator. The distal end 16 is positioned in the patient such that the length of the tip 24 is aligned along the cephalad-caudal direction when puncturing the supraspinous ligament or otherwise aligned substantially parallel to the fibrous strands of the ligament. The wedge-shaped dilator 10 shown in FIGS. 2 a - 2 e does not puncture ligament as readily as the dilator 10 of FIGS. 1 a - 1 e and hence, is typically used in conjunction with a scalpel or other sharp edge, for example, to create a small opening in the ligament prior to insertion of the dilator 10 of FIGS. 2 a - 2 e which then splits the ligament to create a larger opening as it is inserted. For these reasons, the dilator of FIGS. 2 a - 2 e is generally used as a first dilator in a mini-open or open procedure in which direct visual access is gained and a sharp edge is used to first create a cut. The line or rectangular shaped point 24 is centered as seen in FIGS. 2 d and 2 e and therefore advantageously assists in centering the location of the splitting on the ligament. It should be noted that a sharper tip may be formed by a distal end 16 with a more acute angle θ (see FIG. 2 b ) thereby, creating or a approaching a knife-like edge that can pierce the ligament without first using a sharp edge and therefore well suited for truly percutaneous procedures. [0049] Turning now to FIGS. 3 a - 3 e , there is shown another variation of a dilator 10 according to the present invention wherein like reference numbers are used to describe like parts. Referring first to FIG. 3 a , the dilator 10 has an elongated body 12 , a proximal end 14 and a distal end 16 . The dilator 10 includes a pair of channels 18 shown in FIGS. 3 b , 3 c , 3 d and 3 e that are oppositely located from each other and run parallel to the longitudinal axis of the dilator 10 . The distal end 20 of the channel 18 commences in the distal end 16 and the proximal end 22 of the channel 18 ends in the body 12 portion of the dilator 10 . When inserted in a patient and aligned with the adjacent spinous processes, the channels 18 are advantageous for distracting the spinous processes apart as well as for keeping the dilator 10 in position between the spinous processes while being inserted especially in a “kissing” condition of the spine where the posterior tips of adjacent spinous processes are in close proximity, touch or “kiss”. In one variation, the channels 18 are absent from the dilator 10 . The distal end 16 of the dilator 10 is a tapered portion where the diameter or cross-sectional area is less than the diameter or cross-sectional area of the body portion 12 and decreases towards the distal end 16 . In the embodiment shown in FIGS. 3 a - 3 e , the distal end 16 portion has a pyramid shape formed by four substantially flat faces 28 that angle towards each other at the distal end 16 and meet at a tip 24 shown in FIGS. 3 c and 3 d . An end view of the distal end 16 is shown in FIG. 3 d illustrating the tip 24 of the pyramid-shaped distal end 16 . A cannulated variation of the dilator 10 is not shown but is within the scope of the present invention wherein the tip 24 would include an opening. When a cross-section of the distal end 16 is taken at a location distal to the channels 18 and perpendicular to the longitudinal axis of the dilator 10 as shown in FIG. 3 e , the cross-sectional area 26 of the distal end 16 is substantially square in shape. The pyramid-shaped dilator of FIGS. 3 a - 3 e is generally employed as a first dilator 10 and may be cannulated for passing over a guide wire or if used as a subsequent dilator for passing over a previous dilator. The pyramid-shaped dilator 10 shown in FIGS. 3 a - 3 e can puncture ligament and pass through soft tissue and hence, is generally used as a first dilator in a minimally invasive percutaneous procedure without the need to first create a cut with a separate sharp edge such as a scalpel. A sharper tip formed by a distal end 16 with a more acute angle θ (see FIG. 3 b ) will prevent the tip 24 from slipping off to the sides of the ligament. [0050] Turning now to FIGS. 4 a - 4 e , there is shown another variation of a dilator 10 according to the present invention wherein like reference numbers are used to describe like parts. Referring first to FIG. 4 a , the dilator 10 has an elongated body 12 , a proximal end 14 and a distal end 16 . The dilator 10 includes a pair of channels 18 shown in FIGS. 4 b , 4 c , 4 d and 4 e that are oppositely located from each other and run parallel to the longitudinal axis of the dilator 10 . The distal end 20 of the channel 18 commences in the distal end 16 and the proximal end 22 of the channel 18 ends in the body 12 portion of the dilator 10 . When inserted in a patient and aligned with the adjacent spinous processes, the channels 18 are advantageous for distracting the spinous processes apart as well as for keeping the dilator 10 in position between the spinous processes while being inserted especially in a “kissing” condition of the spine where the posterior tips of adjacent spinous processes are in close proximity, touch or “kiss”. In one variation, the channels 18 are absent from the dilator 10 . The distal end 16 of the dilator 10 is a tapered portion where the diameter or cross-sectional area is less than the diameter or cross-sectional area of the body portion 12 and decreases toward the distal end 16 . In the embodiment shown in FIGS. 4 a - 4 e , the distal end 16 portion has a pyramid shape formed by four substantially flat faces 28 that angle towards each other at the distal end 16 and form a tip 24 shown in FIG. 4 d . An end view of the distal end 16 is shown in FIG. 4 d illustrating the tip 24 of the pyramid. A cannulated variation of the dilator 10 is not shown but is within the scope of the present invention wherein the tip 24 would include an opening. When a cross-section of the distal end 16 is taken at a location distal to the channels 18 and perpendicular to the longitudinal axis of the dilator 10 as shown in FIG. 4 e , the cross-sectional area 26 of the distal end 16 is a quadrilateral and, in the variation shown in FIG. 4 e , the quadrilateral is a rhombus in which one of the diagonals 30 or the longest diagonal 30 is aligned with the channels 18 as opposed to the variation of FIGS. 3 a - 3 e in which none of the diagonals are aligned with the channels 18 . It is the intersection of two faces 28 that align with one channel 18 and the intersection of opposite two faces 28 that align with the other channel 18 . In a variation in which no channels 18 are included, the difference between the dilator of FIGS. 3 a - 3 e is in the shape of the quadrilateral. The pyramid-shaped dilator of FIGS. 4 a - 4 e is generally employed as a first dilator 10 and may be cannulated for passing over a guide wire or if used as a subsequent dilator for passing over a previous dilator. The distal end 16 is positioned in the patient such that one of the diagonals or longest diagonal 30 is aligned along the cephalad-caudal direction when puncturing the supraspinous ligament or otherwise aligned substantially parallel to the fibrous strands of the ligament such that the intersection of faces 28 form an edge along which ligament is split. The pyramid-shaped dilator 10 shown in FIGS. 4 a - 4 e in either the channeled or non-channeled variations, splits ligament more readily than either of the channeled or non-channeled variations of the dilator 10 of FIGS. 3 a - 3 e where the intersections of faces 28 are not aligned with the channels 18 or does not have a diagonal 30 that is longer relative to the other diagonal 30 which can be aligned with the fibrous ligament strands for easier splitting. The variation of FIGS. 4 a - 4 e can be used with or without a scalpel or other sharp edge, for example, to create a small opening in the ligament prior to insertion of the dilator 10 of FIGS. 4 a - 4 e which then splits the ligament to create a larger opening as it is inserted. The intersection of faces 28 or diagonal 30 , when aligned substantially parallel to the ligament strands, assist in centering the location of the splitting on the ligament. It should be noted that a sharper tip, intersection or diagonal may be formed by a distal end 16 with a more acute angle θ (see FIG. 4 b ) thereby, creating or a approaching a knife-like edge that can pierce the ligament without first using a sharp edge and therefore well suited for percutaneous procedures. [0051] Turning now to FIGS. 5 a - 5 e , there is shown another variation of a dilator 10 according to the present invention wherein like reference numbers are used to describe like parts. Referring first to FIG. 5 a , the dilator 10 has an elongated body 12 , a proximal end 14 and a distal end 16 . The dilator 10 includes a pair of channels 18 shown in FIGS. 5 b , 5 c , 5 d and 5 e that are oppositely located from each other and run parallel to the longitudinal axis of the dilator 10 . The distal end 20 of the channel 18 commences in the distal end 16 and the proximal end 22 of the channel 18 ends in the body 12 portion of the dilator 10 . When inserted in a patient and aligned with the adjacent spinous processes, the channels 18 are advantageous for distracting the spinous processes apart as well as for keeping the dilator 10 in position between the spinous processes while being inserted especially in a “kissing” condition of the spine where the posterior tips of adjacent spinous processes are in close proximity, touch or “kiss”. In one variation, the channels 18 are absent from the dilator 10 . The distal end 16 of the dilator 10 is a tapered portion where the diameter or cross-sectional area is less than the diameter or cross-sectional area of the body portion 12 and decreases toward the distal end 16 . In the embodiment shown in FIGS. 5 a - 5 e , the distal end 16 portion has two curved faces 28 that angle towards each other at the distal end 16 and form a tip 24 shown in FIG. 5 d . An end view of the distal end 16 is shown in FIG. 5 d illustrating the tip 24 . A cannulated variation of the dilator 10 is not shown but is within the scope of the present invention wherein the tip 24 would include an opening. In yet another variation, the tip 24 includes an opening to a blade housing through which a blade may extend. The blade (not shown) may also be retractable. When a cross-section of the distal end 16 is taken at a location distal to the channels 18 and perpendicular to the longitudinal axis of the dilator 10 as shown in FIG. 5 e , the cross-sectional area 26 of the distal end 16 is comprised of an area bounded by two curved lines in which the length is aligned with the channels 18 . It is the intersections of two faces 28 that align with one channel 18 . In a variation in which no channels 18 are included, the length is aligned with the length of the ligament. The dilator 10 of FIGS. 5 a - 5 e is generally employed as a first dilator 10 and may be cannulated for passing over a guide wire or if used as a subsequent dilator for passing over a previous dilator. The distal end 16 is positioned in the patient such that the length of the tip 24 is aligned along the cephalad-caudal direction when puncturing the supraspinous ligament or otherwise aligned substantially parallel to the fibrous strands of the ligament or to the ligament itself such that the intersections of faces 28 form an edge along which ligament is split. The variation of FIGS. 5 a - 5 e can be used with or without a scalpel or other sharp edge, for example, to create a small opening in the ligament prior to insertion of the dilator 10 of FIGS. 5 a - 5 e which then splits the ligament to create a larger opening as it is inserted. The intersection of faces 28 when aligned substantially parallel to the ligament strands, assist in centering the location of the splitting on the ligament. It should be noted that a sharper tip, intersection or diagonal may be formed by a distal end 16 with a more acute angle θ (see FIG. 5 b ) thereby, creating or a approaching a knife-like edge that can pierce the ligament without first using a sharp edge and therefore well suited for percutaneous procedures. [0052] Turning now to FIGS. 6 a - 6 d , there is shown another variation of a dilator 10 according to the present invention wherein like reference numbers are used to describe like parts. Referring first to FIG. 6 a , the dilator 10 has an elongated body 12 , a proximal end 14 and a distal end 16 . The dilator 10 includes a pair of channels 18 shown in FIGS. 6 b , 6 c and 6 d that are oppositely located from each other and run parallel to the longitudinal axis of the dilator 10 . The distal end 20 of the channel 18 commences in the distal end 16 and the proximal end 22 of the channel 18 ends in the body 12 portion of the dilator 10 . When inserted in a patient and aligned with the adjacent spinous processes, the channels 18 are advantageous for distracting the spinous processes apart as well as for keeping the dilator 10 in position between the spinous processes while being inserted especially in a “kissing” condition of the spine where the posterior tips of adjacent spinous processes are in close proximity, touch or “kiss”. In one variation, the channels 18 are absent from the dilator 10 . The distal end 16 of the dilator 10 is a tapered portion where the diameter or cross-sectional area is less than the diameter or cross-sectional area of the body portion 12 and decreases toward the distal end 16 . In the embodiment shown in FIGS. 6 a - 6 d , the distal end 16 portion has a surface 28 , that may also be curved that angles toward the distal end 16 and forms an opening 32 at tip 24 shown in FIGS. 6 c and 6 d . An end view of the distal end 16 is shown in FIG. 6 d illustrating the opening 32 that forms distal end of the cannulation or bore 34 running along at least part of the length of the dilator 10 . Because of the central bore 34 is sized to received therein a smaller dilator 10 such as any of the dilators described above in FIGS. 1-5 , the dilator 10 of FIGS. 6 a - 6 d is generally employed as a second dilator 10 or dilator 10 subsequent for passing over a previous dilator. The distal end 16 is positioned over a previous dilator 10 in the patient such that the channels 18 are aligned generally perpendicular to the cephalad-caudal direction when puncturing the supraspinous ligament or otherwise aligned substantially perpendicular to the fibrous strands of the ligament or to the ligament itself. When inserted, the cannula of FIGS. 6 a - 6 d continues to distract the spinous processes as they ride in the channels 18 with the channels 18 helping with maintaining the proper orientation of the dilators 10 between the spinous processes. In one variation, the channels 18 are ramped or angled towards the distal end to improve upon the distraction action provided by the dilator. [0053] Turning now to FIGS. 7 a - 7 d , there is shown another variation of a dilator 10 according to the present invention wherein like reference numbers are used to describe like parts. Referring first to FIG. 7 a , the dilator 10 has an elongated body 12 , a proximal end 14 and a distal end 16 . The dilator 10 includes a pair of channels 18 shown in FIGS. 7 b , 7 c and 7 d that are oppositely located from each other and run parallel to the longitudinal axis of the dilator 10 . The distal end 20 of the channel 18 commences in the distal end 16 and the proximal end 22 of the channel 18 ends in the body 12 portion of the dilator 10 . In one variation, the channel 18 includes a flat base between two sidewalls. When inserted in a patient and aligned with the adjacent spinous processes, the channels 18 are advantageous for distracting the spinous processes apart as well as for keeping the dilator 10 in position between the spinous processes while being inserted especially in a “kissing” condition of the spine where the posterior tips of adjacent spinous process are in close proximity, touch or “kiss”. In one variation, the channels 18 are absent from the dilator 10 . The distal end 16 of the dilator 10 is a tapered portion where the diameter or cross-sectional area is less than the diameter or cross-sectional area of the body portion 12 and decreases toward the distal end 16 . In the embodiment shown in FIGS. 7 a - 7 d , the distal end 16 portion has a surface 28 that may also be curved that angles toward the distal end 16 and forms an opening 32 at tip 24 shown in FIGS. 7 c and 7 d . An end view of the distal end 16 is shown in FIG. 7 d illustrating the opening 32 that forms distal end of the cannulation or bore 34 running along at least part of the length of the dilator 10 . Because of the central bore 34 is sized to received therein a smaller dilator 10 such as any of the dilators described above in FIGS. 1-5 , the dilator 10 of FIGS. 7 a - 7 d is generally employed as a second dilator 10 or dilator 10 subsequent for passing over a previous dilator. The distal end 16 is positioned over a previous dilator 10 in the patient such that the channels 18 are aligned generally perpendicular to the cephalad-caudal direction when puncturing the supraspinous ligament or otherwise aligned substantially perpendicular to the fibrous strands of the ligament or to the ligament itself. The dilator of FIGS. 7 a - 7 d further includes a pair of oppositely located flats 36 that are aligned with the channels 18 . At least part of the channel 18 is formed in the flats 36 and in one variation, the flat 36 is substantially parallel to the flat base of the channel 18 . The flats 36 create a lower profile for the dilator 10 which is advantageous for insertion between closely spaced spinous processes. When inserted, the cannula of FIGS. 7 a - 7 d continues to distract the spinous processes as they ride in the channels 18 with the channels 18 helping with maintaining the proper orientation of the dilators 10 between the spinous processes. [0054] An entry point is selected on the patient's skin to obtain access to the targeted surgical site, and an incision of appropriate length is made through the dermal layers of a patient's body at the entry point. The length and depth of the incision may be larger depending on whether the clinician is using an open, mini-open, or minimally invasive, percutaneous approach. If a guide wire is used, the tip of the guide wire is then positioned within the incision and guided toward the spine using a cannulated T-handled trocar. If a ligament such as the supraspinous or interspinous ligament is to be punctured with a sharp edge other than with the dilator, the sharp edge or scalpel is used to create a small cut in the ligament. One of the first dilators, such as any one of the dilators 10 described above in reference to FIGS. 1-5 , is then inserted (over the guidewire if one is used) into the incision and into the cut in the ligament (if the ligament is pre-cut with a scalpel or other sharp edge). The first dilator is properly oriented (such that diagonal or edges are aligned with ligamentous strands as described above) and further inserted to spread apart body tissue and/or pierce and/or split and/or cut the ligament. After the first dilator is inserted a second dilator, such as any one of the dilators 10 described above in reference to FIGS. 6-7 , is then passed over the proximal end 14 of the first dilator and further passed over the first dilator into the incision to further spread apart tissue and/or split the ligament. Any number of additional dilators, that are preferably cannulated for passing over the one or more previous dilators, are then inserted. A dilator with a channel 18 is oriented such that one of the adjacent spinous processes is positioned inside the channel 18 and in one variation, the other of the adjacent spinous processes is tracked inside the oppositely located channel 18 . Such placement of the dilator with respect to the spinous processes stabilizes the dilator with respect to the spine. Advancement of the dilator relative to the adjacent spinous processes, ramps the adjacent spinous processes first at the tip of the distal portion and then inside the channel 18 if one is employed to distract the adjacent spinous processes. Subsequent dilators placed over the previous dilator may further distract the spinous processes. In one variation, the channels 18 themselves may be flat or further ramped to further distract the adjacent spinous processes. After the desired amount of dilation with dilators is achieved, a cannula 40 of the type shown in FIGS. 8 a - 8 b is passed over the last dilator 10 such that the dilators 10 are received in the cannula bore 42 . The cannula 40 may further include oppositely located channels 44 for receiving the adjacent spinous processes, stabilizing the spinous processes with respect to the dilator and for further distraction of the adjacent spinous processes. The channels 44 are formed by four wings 46 extending outwardly from the surface. With the cannula 40 in place, the dilators 10 inside the cannula bore 42 are removed leaving an open cannula bore 42 through which surgery can be performed or an implant be inserted. [0055] All publications mentioned anywhere herein are incorporated herein by reference as part of the detailed description of the present invention to disclose and describe the methods and/or materials in connection with which the publications are cited or in connection with the present invention. The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present invention is not entitled to antedate such publication by virtue of prior invention. Further, the dates of publication provided may be different from the actual publication dates which may need to be independently confirmed. [0056] The preceding merely illustrates the principles of the invention. It will be appreciated that those skilled in the art will be able to devise various arrangements which, although not explicitly described or shown herein, embody the principles of the invention and are included within its spirit and scope.

1a

CROSS REFERENCE TO RELATED APPLICATION [0001] The present application claims the benefit of U.S. Provisional Patent Application No. 60/867,587, filed Nov. 29, 2006, which is incorporated herein by reference. FIELD [0002] This invention relates in general to improvements in wheel mount assemblies of the type used with wheelchairs and other devices. More particularly, this invention relates to an improved wheel mount assembly that provides center of gravity adjustability and wheel camber angle adjustability. BACKGROUND [0003] Wheel mount assemblies in general are well known in the art for use with many different types of wheeled devices. Such wheel mount assemblies are commonly employed for mounting the rear wheels on a typical wheelchair. Each wheel mount assembly typically incorporates a number of adjustments that allow the wheelchair occupant to customize the wheelchair to his or her body proportions, body mechanics, and driving conditions. Frequently, the rear wheels of the wheelchair are cambered, or angled with respect to a vertical plane. A wheelchair with a large camber angle has more responsive turning, which is typically beneficial in sports applications. A wheelchair with a little to no camber angle has a smaller overall width and thus greater manoeuvrability in tight confines. Often the wheels can be adjusted so that their camber angle can be changed from 0 degrees to 12 degrees, or sometimes substantially more, where the top of the wheel is closer to the chair than the bottom of the wheel. [0004] Some wheelchairs provide the ability to adjust the fore/aft position of the rear wheel with respect to the wheelchair frame. Such adjustment is known as a “center-of-gravity” adjustment. Shifting the rear wheels rearward produces a more stable wheelchair that is less likely to tip backwards. Shifting the rear wheels forward makes the wheelchair easier to balance on the rear wheels. This helps with manoeuvrability over obstacles, such as curbs, where the wheelchair occupant must lift the front casters off the ground in order to traverse the obstacles. [0005] When an adjustment is made to the rear wheel camber angle the rear height of the wheelchair may also change, which may in turn cause the rear wheels to toe-in or toe-out. That is to say, the rear wheels become misaligned with respect to the frame. This misalignment is undesirable because it increases rolling friction. If the act of decreasing the camber angle raises the rear wheel height, the rear wheels may toe-in. Conversely, increasing the rear wheel camber angle typically lowers the rear wheel height, which may cause the rear wheels to toe-out. To correct toe-in or toe-out, the mounting hardware that attaches the rear wheels to the wheelchair frame must allow the axles of the rear wheel to rotate in order to re-align the camber angle with respect to a vertical sagittal plane. Alternatively, the height of either the rear wheels or the front caster wheels may be changed to adjust the toe-in or toe-out of the drive wheels as well as to keep the main pivot axis of each of the caster wheels vertical. [0006] With some conventional wheelchairs that offer adjustable camber (although note that in many wheelchairs the camber angle is fixed), the camber adjustment takes the user a significant amount of time. Adjusting the camber often requires removing quite a number of parts and adding or subtracting washers or other spacers to achieve the proper angle. Alternatively adjusting the camber may entail needing different camber inserts each with fixed angles. Even when done by a trained technician, the process may still take considerable time. [0007] In some wheelchairs that provide easier means of changing camber angle and center gravity adjustment, often the result is an overly flexible wheelchair frame. A wheelchair that lacks rigidity or is overly flexible typically has reduced performance, may feel cumbersome or un-safe, and may be more prone to breakage. [0008] While many wheelchairs provide wheel camber angle, toe-in, toe-out, and center of gravity adjustability, there is a need for a lightweight, user-friendly adjustment design that minimizes parts, complexity, and adjustment difficulty while at the same time providing adequate rigidity and performance. SUMMARY [0009] The present disclosure pertains to a wheel mount assembly of the type used with wheelchairs and other devices. [0010] According to a first aspect, there is provided a wheel mount assembly for mounting a drive wheel to a frame of a wheelchair, the assembly comprising a camber body attachable to an axle of one of the drive wheels and operable to pivotably couple about the frame through a range of camber angles; a spacer operable to set a desired camber angle, the spacer contacting the camber body at the desired camber angle; and a clamp operable to secure the camber body and the spacer to the frame at the camber angle. The wheel mount assembly may comprise a clamping member coupled to the frame so as to fix the camber body from pivoting through the camber angles; and a fastener operable to secure the clamping member to the camber body and to the frame. The fastener may be a clamping screw extending through the clamping member and screwed into the camber body. Optionally, the clamping member may be welded to the frame. Additionally, the spacer may be a set screw screwed into the camber body. [0011] Furthermore, the wheel mount assembly may comprise left and right camber bodies, each attachable to one of the drive wheels and each operable to pivotably couple one of the drive wheels about the frame through the range of camber angles; and left and right spacers, each operable to set the desired camber angle, each spacer contacting one of the camber bodies at the desired camber angle; wherein the clamp may comprise a transverse member extendable between the drive wheels and having two ends, each end operable to engage a portion of the frame such that the clamp is prevented from pivoting through the camber angles of each respective camber body; and a pair of fasteners, each fastener operable to secure one of the camber bodies to one of the ends of the transverse member. Each spacer may be a set screw screwed into the camber body. The set screw may abut against the transverse member at the camber angle. The two ends of the transverse member can slidably engage respective longitudinally extending portions of the frame in a longitudinal direction. Furthermore, there may be two metal plugs, each inserted into one of the ends of the transverse member, each metal plug having a radially extending bore therethrough for accepting one of the fasteners. For each drive wheel, an axle receiver insert can be interposed between the axle and the camber body, the axle receiver insertable to different depths in the camber body. The axle receiver insert may comprise an eccentrically located hole for receiving the axle, the hole rotatable within the camber body for adjusting a height of the drive wheel. [0012] According to another aspect of the invention, there is provided a wheelchair comprising a frame; a pair of drive wheels, each having an axle; and a wheel mount assembly for mounting one of drive wheels to the frame, the assembly comprising a camber body attachable to an axle of one of the drive wheels and operable to pivotably couple about the frame through a range of camber angles; a spacer for setting a desired camber angle, the spacer contacting the camber body at the desired camber angle; and a clamp operable to secure the camber body and the spacer to the frame at the camber angle. The clamp may comprise a clamping member coupled to the frame so as to fix the camber body from pivoting through the camber angles; and a fastener operable to secure the clamping member to the camber body and to the frame. The fastener can be a clamping screw extending through the clamping member and screwed into the camber body. Furthermore, the clamping member may be welded to the frame, and the spacer can be a set screw screwed into the camber body. [0013] Furthermore, the wheelchair may comprise left and right camber bodies, each attachable to one of the drive wheels and each operable to pivotably couple one of the drive wheels about the frame through the range of camber angles; and left and right spacers, each operable to set the desired camber angle, each spacer contacting one of the camber bodies at the desired camber angle; wherein the clamp may comprise a transverse member extendable between the drive wheels and having two ends, each end operable to engage a portion of the frame such that the clamp is prevented from pivoting through the camber angles of each respective camber body; and a pair of fasteners, each fastener operable to secure one of the camber bodies to one of the ends of the transverse member. The spacer may be a set screw screwed into the camber body. The set screw can abut against the transverse member at the camber angle. The two ends of the transverse member can slidably engage respective longitudinally extending portions of the frame in a longitudinal direction. Furthermore, there may be two metal plugs, each inserted into one of the ends of the transverse member, each metal plug having a radially extending bore therethrough for accepting one of the fasteners. For each drive wheel, an axle receiver insert can be interposed between the axle and the camber body, the axle receiver insertable to different depths in the camber body. The axle receiver insert may comprise an eccentrically located hole for receiving the axle, the hole rotatable within the camber body for adjusting a height of the drive wheel. [0014] The foregoing and other objects, features, and advantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures. BRIEF DESCRIPTION OF THE DRAWINGS [0015] FIG. 1 is a perspective view of a wheelchair. [0016] FIGS. 2( a ) and ( c ) are perspective views of a wheel mount assembly according to one embodiment; FIG. 2( b ) is a front elevation view of the embodiment illustrated in FIGS. 2( a ) and ( c ). [0017] FIG. 3 is a front elevation view a wheel mount assembly according to a second embodiment. [0018] FIG. 4 is a perspective view of a wheel mount assembly depicting an eccentric axle receiver insert according to a third embodiment. [0019] FIGS. 5( a ) and ( c ) are perspective views of a wheel mount assembly according to a fourth embodiment; FIG. 5( b ) is a front elevation view of the embodiment illustrated in FIGS. 5( a ) and ( c ). [0020] FIGS. 6( a ) and ( c ) are perspective views of a wheel mount assembly according to a fifth embodiment; FIG. 6( b ) is a front elevation view of the embodiment illustrated in FIGS. 6( a ) and ( c ). DETAILED DESCRIPTION [0021] Directional terms such as “left”, “right”, “horizontal”, “vertical”, “transverse” and “longitudinal” are used in this description merely to assist the reader to understand the described embodiments and are not to be construed to limit the orientation of any described method, product, apparatus or parts thereof, in operation with or in connection to another object. [0022] Referring to FIG. 1 , an example wheelchair 1 is depicted having a wheelchair frame 2 with attached rear wheels 3 . The rear wheels 3 are attached to the wheelchair frame 2 by axles inserted into camber bodies 6 . The camber bodies 6 are coupled to horizontal tubes 4 which are members of the frame 2 and which extend longitudinally; that is, the tubes 4 extend from the front to the rear of the frame 2 . The camber bodies 6 and horizontal tubes 4 are also coupled to a transverse tube 5 that transversely spans across the frame 2 . The front of the wheelchair 1 also has caster wheel assemblies 14 attached to the frame 2 . The geometry of this example wheelchair 1 is such that the horizontal tubes 4 lie in a horizontal plane, parallel to the ground, and the housing tubes 18 of the caster wheel assemblies 14 lie in a vertical plane, perpendicular to the horizontal plane. In this configuration, a wheel mount assembly can provide an adjustable camber angle of the rear wheels 3 , while also maintaining negligible toe-in and toe-out effects of the rear wheels. Such a configuration would provide low rolling resistance and an efficient wheeling mechanism. [0023] Referring now to FIGS. 2( a )-( c ), which depict three views of the exemplary embodiment of the wheel mount assembly in detail, the transverse tube 5 consists of a tubular structure with alloy plugs 17 inserted into either end to a depth of approximately 2.5 inches. The ends of the transverse tube 5 are shaped to concentrically couple to the horizontal tubes 4 of the wheelchair frame 2 . Oval or elongated through-holes 12 are formed in the transverse tube 5 through the tube 5 and alloy plugs 17 such that a bolt 8 may pass through the tube 5 at various angles to the vertical. The end of the elongated holes 12 are further shaped to be an elliptical counterbore 11 , such as may be obtained through the use of a ball nose end mill. This counterbore 11 is shaped to receive a spherical washer 9 through which the bolt 8 passes such that regardless of the angle of the bolt 8 to the vertical, the bolt may fasten firmly to the transverse tube 5 . The counterbore 11 is shaped with a sufficient depth to enable the spherical washers 9 to snugly couple to the transverse tube 5 . The bolt 8 can be a socket button head cap screw, for instance, with a head with a flat surface to coincidentally mate with the flat side of the spherical washer 9 . In an alternative embodiment (not shown), instead of using the counterbore 11 to receive the spherical washer 9 , a female spherical washer can be used to receive the spherical washer 9 , with the female spherical washer sitting flat on a machined flat shoulder. [0024] The bolt 8 is screwed into the bottom of a camber body 6 . The camber bodies 6 are shaped to concentrically couple to the horizontal tubes 4 of the wheelchair frame 2 . Another bolt 10 is screwed into the camber body medial to the bolt 8 . This bolt 10 is a socket button head cap screw, for instance, which has a head with a radius. The distal surface of the head of the bolt 10 is coincidentally and approximately concentrically coupled to an elliptical counterbore hole 13 shaped in top of the transverse tube 5 and alloy plugs 17 . This elliptical hole 13 is sufficiently deep to provide a surface with a radius closely matched to the head of the button head screw 10 , again optionally by using a ball nose end mill. [0025] When the bolt 8 is firmly screwed into the camber body 6 , the camber body 6 and the transverse tube 5 mate to the horizontal tube 4 on opposing sides of the tube 4 , the spherical washer 9 mates to the elongated counterbore 11 , and the bolt 10 mates to the elongated counterbore hole 13 . Thus the force of the bolt 8 provides sufficient clamping force to rigidly secure the wheel mount assembly to the wheelchair 1 . [0026] An axle receiver insert 7 is inserted into the camber body 6 . One example of an axle receiver insert 7 is a threaded rod approximately 2 inches long with a bored hole through it to accept a wheel axle. The axle receiver insert 7 can be screwed to various depths into the camber body 6 , thus effectively spacing the wheels 3 laterally with respect to the wheelchair frame 2 . [0027] The distance that the bolt 10 is screwed into the camber body 6 determines the angle α of the camber body 6 to the horizontal. The more the bolt 10 is screwed into the camber body 6 (the shorter the bolt 10 has an exposed length), the greater the angle α becomes. The angle α determines the angle of the wheels in the following relationship. The angle α between the camber body 6 and a horizontal plane is equal to the camber angle of the wheelchair 1 rear wheels 3 with respect to a vertical sagittal plane. The embodiment depicted in FIGS. 2( a )-( c ) provide for the angle α to be adjusted from 0 degrees to approximately 12 degrees. It is appreciated that the angle α can be made even greater by changing the coupling shapes of the camber bodies 6 and transverse tube 5 , as well as the diameters and sizes of the camber bodies 6 , the transverse tube 5 , and the horizontal tubes 4 , and the length of the bolt 10 . [0028] An alternative embodiment is shown in FIG. 3 . Essentially, the wheel mount assembly described above and shown in FIGS. 2( a )-( c ) is flipped upside down. To similarly achieve adjustable wheel camber angles, the bolt 10 is screwed into the camber body 6 to various depths. In contrast to the embodiment depicted in FIGS. 2( a )-( c ), a longer exposed length of the bolt 10 equates to a greater wheel camber angle. One benefit of the embodiment illustrated in FIG. 3 is that the head of the bolts 8 , 10 face upwards, which can make their adjustment easier than that of the bolts 8 , 10 of the embodiment illustrated in FIGS. 2( a )-( c ). [0029] In both embodiments described above, and referring to the example wheelchair 1 in FIG. 1 , it is appreciated that changing the camber angle α of the rear wheels 3 would also change the relative height of the rear of the wheelchair frame 2 . Such a change may tilt the plane in which the horizontal tubes 4 lie such that it is no longer parallel with the horizontal plane, and may also tilt the plane in which the housing tubes 18 of the caster wheel assemblies 14 lie such that it is no longer parallel with the vertical plane. Such changes may increase the toe-in or toe-out of the rear wheels 3 and impact rolling resistance and pushing efficiency. This could be mitigated in the example wheelchair 1 by changing the relative height of the housing tubes 18 of the caster wheel assemblies 14 for a given wheel camber angle in order to adjust the tilt of the planes in which the horizontal tubes 4 and vertical housing tubes 18 of the caster wheel assemblies 14 lie. The relative height of the housing tubes 18 may be changed with washers or spacers. Given the embodiments of the wheel mount assemblies described above, the toe-in and toe-out would then be negligible. [0030] Referring to FIG. 4 , an axle receiver insert 7 with an eccentrically placed hole 15 is shown. This alternative embodiment may be needed if by changing the camber angle of the wheels 3 , the rear height of the wheelchair 1 is raised or lowered, and that this changed height could not be compensated for by changing the height of the caster wheel housings 18 . Such a change in rear height may alter the toe-in toe-out of the rear wheels 3 , thus impacting rolling resistance and pushing efficiency. To alter the toe-in and toe-out to a negligible amount, the axle receiver insert 7 with an eccentric hole 15 can be rotated in the camber body 6 . The eccentric hole 15 would then provide a means to subtly alter the toe-in and toe-out of the rear wheels 3 . Once the optimum rotational placement of the axle receiver insert 7 with an eccentric hole 15 is achieved, the position can be fixed in place by tightening the jam nut 16 firmly against the camber body 6 . [0031] Referring now to FIGS. 5( a )-( c ) and 6 ( a )-( c ), embodiments of the present invention wherein the transverse tube 5 is absent are depicted. In FIGS. 5( a )-( c ) and 6 ( a )-( c ), in lieu of the transverse tube 5 , a lower camber body 19 is present. The bolt 10 abuts against the lower camber body 19 instead of the transverse tube 5 when the camber body 6 is at the desired camber angle α. Referring specifically to FIGS. 5( a )-( c ), the lower camber body 19 is welded to the horizontal tube 4 , as evidenced by the presence of a weld bead 20 . Referring specifically to FIGS. 6( a )-( c ), the lower camber body 19 is secured to the horizontal tube 4 with a pin 19 , which extends through the lower camber body 19 , the horizontal tube 4 , and the camber body 6 . The combination of the pin 19 and the clamping force resulting from the bolt 8 result to prevent movement of the camber bodies 6 , 19 about the tube 4 . While the camber bodies 6 , 19 depicted in FIGS. 5( a )-( c ) are necessarily fixed to the horizontal tube 4 at the location of the weld bead 20 , the camber bodies 6 , 19 depicted in FIGS. 6( a )-( c ) are movable to different positions along the horizontal tube 4 so long as at each position to which the camber bodies 6 , 19 are to be moved, a channel for receiving the pin 19 exists within the tube 4 . [0032] All embodiments described above, and others not shown here, also provide another feature: the wheel mount assembly can be slid rearwards and forwards along the horizontal tubes 4 and clamped in position. By changing the clamping position along the horizontal tubes 4 , the center of gravity of the wheelchair 1 can be changed. [0033] The components of the wheel mount assembly can be manufactured from a light alloy material to reduce the weight of the wheelchair 1 . Suitable such materials include steel alloys, aluminum alloys, titanium alloys, magnesium alloys, plastics such as polycarbonate, carbon fibre composites, and other materials suitable for such an application. By selecting such materials and by utilizing the design of the wheel mount assembly described here, it is expected that the weight of the wheelchair 1 can minimized. [0034] The embodiments described herein can offer several advantages. For instance, the lateral distance between the rear wheels 3 may be adjusted by varying the insertion depth of the axle receiver insert 7 within the camber body 6 . In the embodiments of the invention wherein the camber bodies may be coupled at different positions along the horizontal tubes 4 , the center of gravity of the wheelchair may be adjusted. The camber angle of the wheels 3 may be adjusted by removing bolts 8 and un-clamping the wheel mount assemblies. The depths of the bolts 10 can then be adjusted and the wheel mount assemblies re-clamped. The toe-in and toe-out of the wheels 3 may be adjusted by changing the heights of the caster wheel housings 18 or by rotating the axle receiver inserts 7 with eccentrically placed holes 15 . [0035] While the present invention has been described herein by the preferred embodiments, it will be understood to those skilled in the art that various changes may be made and added to the invention. The changes and alternatives are considered within the spirit and scope of the present invention.

1a

BACKGROUND OF THE INVENTION The invention relates to a fish lure, and in particular, to a fish lure having interchangeable body parts. A wide variety of fish lures are designed to catch certain fish in particular different circumstances. For example, the type of fish which is to be caught, weather conditions, time of day and other factors determine which particular lure will be most effective to catch the fish at a particular time and location. For this reason, most fishermen have a relatively large collection of lures which are used in various fishing endeavors. The present invention is directed to a fish lure having an interchangeable body sleeve whereby a single generic lure body may be transformed into a variety of different lure types, thereby eliminating the necessity of having multiple lures. The invention provides a rigid lure body which is connected to a line and uses a flexible body sleeve which is placed over the rigid body. Sleeves are designed in a variety of configurations, sizes and colors, and when used in combination with the generic body, create a different lure configuration with each sleeve. While fishing, a fisherman can easily interchange one body sleeve for another without taking the lure off of the line by simply removing the rear treble hook and sliding off the sleeve that is being used and replacing it with another sleeve. This permits the fisherman to experiment as to what lure design, color, size or other feature catches the most fish without having to undergo the tedious process of attaching and detaching a variety of different lures. Among the objects of the present invention are the provision of a generic fish lure capable of a variety of different configurations using interchangeable body sleeves, the provision of a lure which eliminates the need for attaching and detaching lures from a line when a lure change is desired and the provision of a lure which eliminates the need for a large number of different lure configurations for various fishing conditions. These and other objects will become apparent from the following description and drawings. DESCRIPTION OF THE DRAWINGS FIG. 1 shows a top perspective view of an assembled fish lure in accordance with the present invention. FIG. 2 is a side elevational view thereof. FIG. 3 is an elevational view of a generic form of a lure in accordance with the present invention. FIG. 4 is a view of the lure disassembled. FIGS. 5A through 5E show alternate embodiments of interchangeable body sleeves used with the present invention. DESCRIPTION OF THE PREFERRED EMBODIMENTS FIGS. 1 and 2 show views of a lure 10 in accordance with the present invention in an assembled condition. The lure 10 includes a head 12 having a variety of features, such as a bill 16 and eyes 18. The head also includes a hook eye 14 for attaching a fishing line, which eye is preferably attached to the bill 16 A body portion 20 of the lure 10 includes front treble hook 21 and a rear treble hook 22. An interchangeable body sleeve 24 is shown in place over the body 20, as further described hereinbelow. FIG. 3 shows a generic form of the lure 10 without the body sleeve 24 and rear treble hook 22 as shown in FIGS. 1 and 2. Referring to FIG. 4, the fish lure of the present invention is shown in a disassembled condition. The body 20 is preferably attached to the head 12, and extends rearwardly therefrom. It is contemplated that the body 20 be formed in a curved cylindrical configuration with a forward end 25 and a distal tail end 26. Each body sleeve 24 takes the form of a flexible, tubular sleeve having an outer design to attract fish and an opening 27 on one end thereof. Preferably, the sleeve is made of plastic, fabric or other similar flexible material. Notwithstanding various outer design features, the body sleeve 24 is sized to be attached onto the body 20 by sliding distal tail end 26 of the body 20 into the opening 27 in the sleeve 24 until the forward end of the sleeve abuts the head 12 of the lure 10. Preferably, a light lubricant is used to facilitate the process. The rear treble hook 22 is removable, using a suitable screw 28, or other suitable attaching means to enable the body sleeve 24 to be attached directly on the body 20 without interference. When the sleeve 24 is in place on the lure body 20, the screw 28 is reattached to complete the lure. FIGS. 5A through 5E disclose a variety of body sleeves, 24A through 24E respectively, showing various outer designs to simulate a variety of bait types. It will be appreciated that the number of sleeves shown are exemplary only, and that an infinite variety of sleeves of various sizes, colors, shapes and so forth may be used with the present invention to attract fish in keeping within the spirit and scope of the present invention as defined in the following claims.

1a

DESCRIPTION This invention relates to an insert for seats in general and, in particular, to seat cushions and backs of seats for motor vehicle seats. With reference to motor vehicle seats, to which the invention is specifically but not exclusively applied, said seats are provided with a tubular metal frame apt to support the padding by means of the elastic inset or inserts. The known types of inserts consist of a flexible structure comprising steel springs and denote considerable drawbacks caused by friction between the elements of said structure and the fixing ends. Moreover, deformation of the springs can cause breakage and destruction of the padding as well as noise and creaking due to the metal parts rubbing against each other. Furthermore, the embodiment of such inserts is complex and consequently uneconomic. The present invention proposes to eliminate the above and other drawbacks and to provide an elastic insert, satisfactory from all aspects and which allows to obtain in an easy and rational manner, predetermined and controlled springing actions according to the requirements and end use of the invention. A further object of the invention is to provide an insert which besides having the desired comfort is of simple construction, which obviously leads to economic advantages. The insert according to the present invention is characterized in that together with the metal supporting frame, it has at least one flexible plate connected to said frame by elastic elements. The elastic elements are advantageously made in rubber or a similar material and have a practically continuous and flat surface, said elements being secured to said supporting frame. This concept can, in practice, lead to various embodiments of the insert all of which fall within the scope of the present invention. The continuous surface elastic elements are, at least in part, annularly shaped, securable, on one side, to the flexible plate or plates and, on the other side, to the supporting frame of the insert. In order to provide inserts having areas of different and desired elasticity, the flexible plate or plates are provided with shaped apertures apt to delimit the zones of controlled flexibility, in order to form zones of differing longitudinal or transversal flexibility. According to one advantageous embodiment of the insert, the flexible plates are made of plastic material, such a polyethylene, polypropylene, etc., preferably obtained by molding, and the thickness of which may be conveniently varied. Moreover, the plates may incorporate reinforcements, such as cross bars or similar expedients, to retain connecting means and securing hooks. The invention will now be described in conjunction with the annexed drawings which illustrate, by way of example, some forms of embodiment of the insert according to the present invention. In the drawings: FIG. 1 is the vertical cross-section of a motor vehicle seat, with seat cushion and back of seat, provided with the inserts according to the present invention; FIG. 2 is a detail, in elevation of the frame of the back of the seat shown in FIG. 1; FIG. 3 is a detail on a scale larger than that of FIG. 2; FIG. 4 is a variant of the embodiment of the back of the seat according to FIG. 2, whereas FIG. 5 is a detail in cross-section; FIG. 6, identical to FIG. 2, shows in transversal cross-section a further embodiment of the insert; FIG. 7, is a variation of the embodiment of an elastic element. With reference to the figures in the drawings, A indicates the seat, the seat cushion of which is equipped, in the known manner, with a reclining seat back. The seat back and seat cushion are both fitted with a metal frame B (see also FIGS. 2 and 3) of suitable contour and advantageously consisting of a tubular metal element 10 apt to retain, as described herebelow, insert C consisting of one or more plates 12, suitably arranged with respect to each other in rows or columns. The insert shown in FIGS. 2 and 3 of the drawing consists of a plurality of flexible plates arranged in rows with respect to supporting frame B. In the case illustrated, plates 12 are two in number per row, each being conveniently arranged for the purposes to be explained hereafter. Each one of flexible plates 12 is provided, at one of its vertical ends, with an aperture 16 which forms a cross bar 18, provided in its mid part with a slot 20 conveniently inclined with respect to the longitudinal axis of said cross bar. Cross bar 18 is adapted to retain an elastic element 22 which, in the case illustrated, is annularly shaped and joins the two or more flexible plates 12 which constitute the row or rows retained by supporting frame B to each other, thereby exerting on said plates a traction. The other vertical end of flexible plate 12 considered in FIGS. 2 and 3, terminates with a fin 24 which is folded as a hook to embrace, with an amplitude of at least 180°, risers 10 of supporting frame B to ensure the securing of insert C to said frame. FIG. 4 shows a different embodiment of insert C for one of the frames B of the seal illustrated in FIG. 1. Insert C of the embodiment consists of one only flexible plate 12a, of a suitable width, provided along its vertical edges with a plurality of slots 16a which retain corresponding elastic annular elements 22a. Each one of said elements is secured to riser 10a of frame B by means of a plate, the extremity 24 of which is folded over to form a hook (see also FIG. 6). In the version according to FIG. 5, insert C, held by frame B, consists of a plurality of flexible plates 12b arranged according to rows and columns perpendicular to each other. Each of said plates is provided with slots 16b and 17 on its longitudinal and transversal edges, apt to retain annular elastic elements 22b and 23, secured to said frame B by means of hooks 24b and 25. Moreover, two or more of flexible plates 12b are vertically and/or horizontally connected to one another by intermediate elastic elements 28, secured to plates by slots 17 on the edges of said contiguous plates. Lastly, FIG. 7 illustrates a variation of the embodiment of the elastic element consisting of a tension element 22 having a slotted end, the extremities of which are secured, respectively, one to the flexible plate and the other to frame B by means of hooks 40 in said frame. Other variations and modifications may be embodied according to different requisites of use called for in each case, for example, and as shown in FIG. 3, the engagement of elastic elements 22 in apertures 16 of flexible plates 12 may be implemented by a feather edge or a dove tail connection 30, provided in a suitable position between cross piece 18 and the corresponding extremity of flexible plate 12. Moreover, and in order to provide an insert C having the desired characteristics of elasticity and flexibility, apertures 14 in flexible plates 12 can be conveniently shaped so as to obtain longitudinal and/or transversal areas of different flexibility. The possibility is not excluded of manufacturing said plates 12, at least in part, with a metallic material and that is, at the limits, said plates may be made totally in metal or provided with metallic reinforcements embedded or distributed in their different sections, particularly in the position of cross bars 18 and/or securing hooks 24. The same applies to elastic elements 22, the width and/or thickness of which may vary depending on the elastic action they are to develop. It is understood that the present invention also covers the seat, the seat cushion and/or seat back which incorporate the insert according to the invention. In practice, the construction details may be varied without, however, departing from the scope of the invention and, therefore, from the field of the patent.

1a

CROSS REFERENCES AND RELATED SUBJECT MATTER This application is a continuation-in-part of patent application Ser. No. 10/716,155, filed in the United States Patent Office on Nov. 18, 2003 now U.S. Pat. No. 6,960,989. BACKGROUND OF THE INVENTION The invention relates to a detectable warning system. More particularly, the invention relates to a system for easily and effectively applying prefabricated detectable warnings to pavement to provide a tactile warning to pedestrians regarding a hazardous transition. It is well known that persons with little or no usable vision depend upon environmental cues—ambient sounds, edges and other physical elements that can be sensed by a cane, and texture changes underfoot—for safe and independent travel. People with low vision can also use color contrast as a navigation aid. When raised curbs do not mark and separate the pedestrian route on a sidewalk from the vehicular way, as at curb ramps, vehicle drop-offs, or depressed corners at intersections, it is difficult for some pedestrians to discern the boundary between pedestrian safety and hazard. Because of the inherent danger caused by transitions without textural changes, the Americans with Disabilities Act Accessibility Guidelines (ADAAG) requires that detectable warnings be installed onto pavement or ground surfaces at certain hazardous junctures. The detectable warnings provide a contrasting texture that signals a hazardous condition to the pedestrian, and thereby informs the pedestrian to exercise care. In particular, the current regulation requires that the detectable warning consist of truncated domes having a nominal diameter of 0.9 inches, protruding from the ground surface to a height of 0.2 inches, and having a center-to-center spacing of 2.35 inches. In addition, the warning should be of contrasting color to effectively warn those who have greatly reduced vision. In many cases, the warnings must be retrofitted onto existing ground surfaces. Further, the installation of such warnings is not readily compatible with standard paving techniques. Accordingly, the detectable warnings are most typically installed onto already existing pavement surfaces. Some have proposed systems for the creation and installation of the domes. Generally these systems involve the use of templates to create the dome “in place”. Others have proposed systems of prefabricated warning domes. For example, TOPMARK proposes a system of preformed thermoplastic detectable warnings that is installed in sheets that have a plurality of thermoplastic domes. Unfortunately, the use of thermoplastic warning domes makes the system extremely difficult to install, since heat must be used to install the sheets, but heat will deform or destroy the thermoplastic domes. My previous patent application described a system wherein warning domes are encapsulated between a top layer and a base layer of thermoplastic. The present invention contemplates a single attachment layer that both maintains the warning domes in position and adheres the dome carrier assembly to the recipient pavement surface. While these units may be suitable for the particular purpose employed, or for general use, they would not be as suitable for the purposes of the present invention as disclosed hereafter. SUMMARY OF THE INVENTION It is an object of the invention to provide a system for allowing the effective installation of detectable warnings upon a pavement surface using heat, wherein the warning domes are not harmed during application to said pavement surface. Accordingly, the detectable warnings are made of a heat resistant casting material that is joined to a layer of thermoplastic. The thermoplastic allows the warnings to be effectively mounted and evenly distributed on the pavement surface. It is another object of the invention to provide a system for allowing the easy fabrication of detectable warning dome carriers for quick and easy subsequent installation of a plurality of domes simultaneously. Accordingly, by a first embodiment, a mold is used to initially create a top layer of thermoplastic material and create the detectable warning domes thereupon. Upon removal from the mold, the detectable warning dome carriers may be easily adhered to pavement surfaces by the application of heat. In particular, the thermoplastic top layer drapes over the domes and adheres to the pavement surface. The domes themselves also rest upon the pavement surface but are held thereagainst by the top layer. Further, by a second embodiment, a mold is used to initially create the detectable warning domes, and then create a base layer thereupon within which the warning domes are adhered and partially submerged. The base layer is adhered to the pavement surface and secures the domes thereonto. The invention is a detectable warning system, for tactily signaling the presence of a terrain transition to a pedestrian, using a plurality of detectable warning domes that are arranged in a grid within a detectable warning carrier assembly. The detectable warning carrier assembly comprises heat resistant detectable warning domes and an attachment layer that may be one of a top layer and a base layer. The attachment layer is heated and adhered to a pavement surface. The detectable warning domes protrude from the pavement surface in an evenly spaced pattern that is detectable by the pedestrian using a cane or other guidance instrument. To the accomplishment of the above and related objects the invention may be embodied in the form illustrated in the accompanying drawings. Attention is called to the fact, however, that the drawings are illustrative only. Variations are contemplated as being part of the invention, limited only by the scope of the claims. BRIEF DESCRIPTION OF THE DRAWINGS In the drawings, like elements are depicted by like reference numerals. The drawings are briefly described as follows. FIG. 1 is a diagrammatic perspective view illustrating a first embodiment of a detectable warning carrier assembly, having a plurality of detectable warning domes below a top layer of thermoplastic. FIG. 2 is a cross sectional view of a mold used in the creation of the detectable warning carrier assembly, wherein a thermoplastic sheet has been placed to span the mold and extend across a plurality of dome forming cavities. FIG. 3 is a cross sectional view similar to FIG. 2 , except wherein heat is applied to melt the thermoplastic sheet so that it conforms to contours of the mold. FIG. 4 is a cross sectional view, similar to FIG. 3 , except wherein a heat resistant casting material has been added to the mold to form detectable warning domes within the dome forming cavities. FIG. 5 diagrammatic perspective view illustrating the first embodiment of the invention installed onto a pavement surface. FIG. 6 is a cross sectional view of the detectable warning carrier assembly installed on the pavement surface, as indicated by line 6 — 6 in FIG. 5 , showing the domes resting upon the pavement surface and the top layer adhered to the pavement around the domes, holding the domes securely against the pavement surface. FIG. 7 is a cross sectional view of a mold used in the creation of a second embodiment of the detectable warning carrier assembly, wherein a heat resistant casting material has been introduced into the dome forming cavities. FIG. 8 is a cross sectional view of the second embodiment, wherein a sheet of thermoplastic material has covered the domes created within the dome forming cavities. FIG. 9 is a cross sectional view of the second embodiment, wherein heat is applied to conform the thermoplastic materials to the domes and to adhere the thermoplastic material to the domes. FIG. 10 is a diagrammatic perspective view, wherein the detectable warning carrier assembly of the second embodiment has been applied to the pavement surface. FIG. 11 is a cross sectional view, taken generally in the area of line 11 — 11 in FIG. 10 , illustrating the base layer adhered to the pavement surface, with the domes exposed thereabove and held to the pavement surface with the base layer. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS In the present application, both a first embodiment and second embodiment of the detachable warning carrier assembly, 101 and 102 , are presented. FIGS. 1–6 illustrate the first embodiment, and FIGS. 7–11 illustrate the second embodiment. Each of the embodiments include an attachment layer of thermoplastic material. FIG. 1 illustrates a first embodiment of a detectable warning carrier assembly 101 comprising a plurality of detectable warning domes 12 arranged in an evenly spaced, grid-like pattern, and covered beneath a top layer 16 . The top layer 16 is the attachment layer in the first embodiment. The carrier assembly 101 is substantially planar in between detectable warning domes 12 . The domes 12 are preferably truncated, such that they are flattened on top. To facilitate proper application of the detectable warning carrier assembly 101 , the top layer 16 is preferably made of thermoplastic. The use of thermoplastic allows the top layer 16 to melt so as to conform to the contours of the recipient surface, and to effectively bond with said recipient surface by flowing into cracks and pores present thereon. Referring to FIG. 2 , formation of the first embodiment of the detectable warning carrier assembly centers upon a mold 20 having a top surface 22 and a plurality of dome forming cavities 24 extending downwardly from the top surface 22 . The dome forming cavities 24 are shaped like inverted truncated warning domes and are spaced apart as required by regulations such as ADAAG 4.29.2, and to otherwise function as an effective detectable warning. The dome forming cavities 24 are dimensionally modified to accommodate a coating of thermoplastic as will be apparent hereinafter. A first sheet of thermoplastic 26 is illustrated extending across the top surface 22 , spanning the mold 20 , and thereby extending across all dome forming cavities 24 . The first sheet of thermoplastic 26 may actually be numerous sheets of thermoplastic that are adjacent and/or overlap each other so that they together substantially span the top surface 22 of the mold 20 . Referring now to FIG. 3 , heat 28 is applied to the thermoplastic sheet 26 to a temperature sufficient to substantially melt the first sheet of thermoplastic, so that it forms a one-piece, continuous, top layer 16 of the detectable warning carrier assembly 101 being formed. Accordingly the top layer 16 flows into the dome forming cavities 24 where it conforms to the mold 20 , taking the shape of the dome forming cavities 24 , and spanning the top surface 22 with one continuous piece. The top layer 16 , however, is substantially thin, and thus does not fill the dome forming cavities 24 , nor does it substantially obscure the topography thereof. Referring now to FIG. 4 , heat resistant casting material 30 has been added to substantially fill each of the dome forming cavities 24 . In particular, the dome forming cavities 24 have been filled to a height substantially equivalent to the top surface 22 , or more particularly—to substantially the height of the top layer 16 as it extends across the top surface 22 . The heat resistant casting material is flowable but settable, hardens in time, and is preferably a masonry material such as concrete. Note that the casting material is shown as uneven at its uppermost surface—this is to emphasize its flowability and viscosity. The casting material will, however, settle and form a substantially flat dome base surface 12 A, as seen in FIG. 6 . Preferably the dome base surface 12 A is substantially coplanar with the top layer 16 . Note that prior to the addition of the casting material, sand may optionally be sprinkled into the mold, while the thermoplastic is still hot, to adhere to the not-yet-cured top layer. Such sand may be added to facilitate a strong bond between the casting material and the thermoplastic top layer. Alternatively, formable heat resistant plastic, such as thermosetting plastic, may be introduced into the mold to form the domes. Once set, such plastic will resist subsequent melting, but may melt slightly on the surface sufficient to establish a strong bond between the dome and top layer 16 . In general, a variety of heat resistant materials can be used for the domes 12 , including chemical compounds, mixtures, resins, polymers, glass, organic or inorganic substances, metals or other materials that have heat resistant properties. An important parameter of the heat resistant casting material is that it can resist temperatures of approximately 300–500 degrees Fahrenheit, so as to endure the bonding process that will be subsequently described. If additional strength is desired, a strengthening grid, such as a mesh material, can be introduced at this point. Accordingly, such a mesh grid can be placed upon the top layer 16 so that it substantially spans the mold, and adheres to all domes. The additional strength provided by the strengthening grid helps make the invention more suitable for use on a surface where vehicles or other heavy equipment might be used. In this regard, rather than casting the domes in place, performed domes can be introduced into the mold, with or without a pre-existing mesh grid holding a plurality of domes together. For example, the domes may be injection molded in a group, wherein members that connect the domes together are simultaneously formed during the injection molding process. The entire grouping of domes can then be placed within the dome forming cavities with the connecting members extending parallel to the top surface 22 of the mold 20 . In such a case, the domes are made of a heat resistant plastic material. In addition, a plurality of domes can be joined and mounted upon a veneer of brick or other earthen material. The domes and veneer are then placed into the mold, with the domes resting against the top layer 16 within the dome forming cavities. The domes and veneer (along with adjacent veneers holding their own domes) are then adhered to the thermoplastic material by any suitable means. Referring now to FIG. 5 , to install the detectable warning carrier assembly 101 , the top layer 16 is placed upon a pavement surface 40 near a hazardous transition point 42 , which also places the dome base surfaces 12 A upon the pavement surface (best seen in FIG. 6 ). In the environmental context provided within FIG. 5 , a curb cut 44 creates the transition point 42 at which it is necessary to provide a textured, tactile warning. When suitably positioned adjacent to the hazardous transition point, and trimmed to fit, heat is applied to partially melt the top layer 16 . A simple torch may be used to supply the necessary heat. As the top layer 16 melts, it will flow into cracks, crevices, and pores of the pavement 40 . Once it has been allowed to cool, it remains permanently attached to the pavement 40 , and the domes 12 will provide tactile feedback to any pedestrian approaching the transition point 42 . Referring to FIG. 6 , the substantially flat dome base surfaces 12 A of each dome rest upon the pavement surface. The top layer 16 both covers and drapes downwardly over each of the domes 12 and then extends substantially coplanar with their base surfaces 12 A, such that the top layer 16 can adhere to the pavement surface 40 and hold the domes 12 downwardly thereagainst. FIGS. 7 thru 11 illustrate a second embodiment of the detectable warning carrier assembly 102 . In the second embodiment, a base layer 14 is employed as the attachment layer—to both maintain the positioning of the domes 12 and to adhere to a recipient pavement surface. Formation of the second embodiment is illustrated in FIGS. 7 thru 9 . In FIG. 7 , the heat resistant casting material 30 has been added directly into the mold to partially fill the dome forming cavities 24 of the mold 20 . In particular, the heat resistant casting material 30 is added until it substantially reaches the top surface 22 of the mold 20 . What will become the dome base surfaces 12 A are shown as uneven in an exaggerated sense to emphasize the flowability of the casting material. The dome base surfaces 12 A are still, in fact, preferably somewhat uneven to facilitate secure attachment to the base layer 14 as will be illustrated hereinafter. In FIG. 8 a second sheet of thermoplastic material 32 has been overlaid upon the mold, spanning the top surface thereof, to coat the detectable warning domes 12 and with a continuous piece of thermoplastic material to form the base layer 14 . In particular, the second sheet of thermoplastic material 32 spans the mold 20 , covers all the detectable warning domes 12 (inverted and within the dome forming cavities). Then in FIG. 9 , heat 28 is applied to bring the second sheet of thermoplastic material 32 into a melted or plastic state so that it flows to adhere to the base surface 12 A of the detectable warning domes 12 . Thus, the second sheet of thermoplastic material 32 becomes the base layer 14 of the detectable warning carrier assembly 102 . To facilitate the adhering to the base surface 12 A, sand may be sprinkled over the domes 12 , or other means employed to facilitate a secure joint between the domes 12 and base layer 14 . After cooling, the detectable warning carrier assembly 102 may be removed from the mold—by separating the base layer 14 from the mold. The carrier assembly 102 is then inverted. As seen in FIG. 11 , when fabricated carefully, the base layer 14 is substantially planar, and the domes 12 are mounted thereon. Referring to FIG. 10 , to install the second embodiment of the detectable warning carrier assembly 102 , the base layer 14 is placed upon the pavement surface 40 near the hazardous transition point 42 created by the curb cut 44 . When suitably positioned adjacent to the hazardous transition point, and trimmed to fit, heat is applied to partially melt the base layer 14 . A simple torch may be used to supply the necessary heat. As the base layer 14 melts, it will flow into cracks, crevices, and pores of the pavement 40 . Once it has been allowed to cool, it remains permanently attached to the pavement 40 , and the domes 12 provide tactile feedback to any pedestrian approaching the transition point 42 . The domes 12 are exposed above the base layer 14 . As illustrated in FIG. 11 , the base layer 14 rests upon the pavement surface 40 to which it is adhered, the domes 12 are themselves adhered to the base layer 14 . In conclusion, herein is presented a detectable warning system for use on a pavement surface. The invention is illustrated by example in the drawing figures, and throughout the written description. It should be understood that numerous variations are possible, while adhering to the inventive concept. Such variations are contemplated as being a part of the present invention.

1a

FIELD [0001] The present invention relates to a feminine hygiene product dispenser. TECHNICAL FIELD OF THE INVENTION [0002] This invention relates generally to a dispenser for feminine hygiene products wherein the products are easily accessed by lifting or sliding a lid, and after the selected product is removed, the lid self-closes protecting the remaining products. BACKGROUND OF THE INVENTION [0003] Feminine hygiene products come in many forms including sanitary napkins, vaginal tampons, panty liners, and panty shields. These products are generally sold in box packaging containing a plurality of individual units. The box packaging usually displays the contents of the box via external advertising and is usually constructed from a paper product. The box packaging is not easily opened and closed, often tearing or failing to adequately seal the remaining product from contaminants once opened. The external advertising and paper packaging makes the box the hygiene products came in an undesirable storage option, and definitely not a desirable option if kept in plain view. Women often store the box packaging and hygiene product out of sight, under the sink, or in a bottom drawer, making access more difficult and contamination more likely. A preferred storage location would be sterile or aseptic, and easy to access. [0004] Easy access becomes imperative for women with limited motility, the handicapped, and the aging. A good location for storage and easy access would be the bathroom countertop, however the undesirable box packaging prevents placement there. Many women require habitual and regular feminine hygiene products, and repeatedly accessing a difficultly located product is undesirable. [0005] Therefore it is desirable to have a dispenser for feminine hygiene products that is pleasing to look at, so as to be placed for convenient access, is easy to open and close, and which will maintain a protected environment for the unused hygiene products. [0006] Boxes, containers, packages, and cases for holding or storing general items are numerous. There are many of the same constructed specifically for feminine hygiene products. However, none satisfy the described needs above. PRIOR ART [0007] Boxes and containers with lids are well known in the art. Simple cigar type boxes have been used to package various tobacco products and after emptied of the original contents, the cigar box has been historically utilized for protecting or keeping personal items safe and secure. When used to package tobacco products, the cigar box is of a shape and dimension, usually rectangular, to match the stacking of the tobacco products to maximize the number of products contained within the box. Cigar type boxes are generally constructed to be durable enough to be utilized beyond the original purpose of packaging. The cigar box tends to be ornate and appealing to look at, often with gold inlay or wooden trim. The indication from the cigar box appearance is that the user is proud of its contents, and displays the box prominently in plain view on a desk or table When the lid is closed, the cigar box seals the tobacco products from the outside environment, protecting the contents. The advantages of the cigar box include sealing the product from the outside environment, constructed to contain many tobacco products, aesthetically pleasing, and able to be opened with a specific pressure and lift of the lid. The disadvantages of a cigar box, when used for containing items other than tobacco product is that the size and dimension cannot accommodate some items such as feminine hygiene products. The lid requires specific pressure, and often times, a hook of a fingernail to open. Finally, in the context of feminine hygiene products, the user may not desire the contents of the box to be known, and therefore a discrete pleasing appearance is preferred. [0008] U.S. Pat. No. 4,286,639 to Murphy discloses a flexible, flat, wallet-like case for enclosing a single tampon or sanitary napkin. Murphy's teaching is directed to a single-pocket case with the additional object of maintaining thinness. The characteristics of thinness, flexibility and the ability to hold only one tampon or sanitary napkin limit the usefulness of Murphy's invention. It is not suitable for carrying a variety of feminine hygiene products. [0009] U.S. Pat. No. 3,557,853 to Jones discloses a foldable cloth bag for carrying one or two sanitary napkins but fails to teach a dispenser for home use that is easy to open and able to store many feminine hygiene products. [0010] U.S. Pat. No. 4,964,526 to Stephens teaches a case specifically designed to house a variety of feminine hygiene products of various sizes for easy carrying and access, but fails to teach of a dispenser for home use that would hold a plurality and/or variety of feminine products. [0011] U.S. Pat. No. 2,843,170 to Frankfurt discloses a flexible case for sanitary napkins. The primary disadvantages of the case are that it is flexible and it is configured to primarily accommodate sanitary napkins. In addition, the case's general construction, including its combination of zippers and snaps, does not provide an easily accessible dispenser. OBJECTS AND ADVANTAGES [0012] It is an object of the present invention to provide a dispenser for a plurality of feminine hygiene products, that is pleasing to look at but not descriptive of contents allowing for accessible placement in the bathroom, bedroom, or convenient accessible location. [0013] It is also an object of the present invention to provide a dispenser that is easy to open and close for the ordinary user, as well as the user who suffers from limited motility, arthritis, or other physical limitations. [0014] It is a further object of the invention is to provide a dispenser that stores the unused feminine hygiene products in an aseptic or clean environment safe from damage or contamination. [0015] It is also a further object of the invention to provide a dispenser of a size and dimension matching the feminine hygiene product desired to be stored within, so that the feminine hygiene product precisely stacks within the dispenser, maximizing the number of product stored while still maintaining the intended shape. [0016] Other aspects, objects, features and advantages of the present invention will become apparent to those skilled in the art upon reading the detailed description of a preferred embodiment in conjunction with the accompanying drawings and appended claims. DESCRIPTION OF THE DRAWINGS [0017] FIG. 1 is a perspective drawing of a hinged-lid feminine hygiene product dispenser, in accordance with one embodiment. [0018] FIG. 2 is a two-dimensional left-view of the hinged-lid feminine hygiene product dispenser of FIG. 1 . [0019] FIG. 3 is a two-dimensional right-view of the hinged-lid feminine hygiene product dispenser of FIG. 1 . [0020] FIG. 4 is a two-dimensional view of the top-view of the hinged-lid feminine hygiene product dispenser of FIG. 1 . [0021] FIG. 5 is a two-dimensional bottom-view of the hinged-lid feminine hygiene product dispenser of FIG. 1 . [0022] FIG. 6 is a two-dimensional rear-view of the hinged-lid feminine hygiene product dispenser of FIG. 1 . [0023] FIG. 7 is a two-dimensional front-view of the hinged-lid feminine hygiene product dispenser of FIG. 1 . DETAILED DESCRIPTION [0024] Referring now to the drawings, and particularly to FIGS. 1-7 , a preferred embodiment of the present device is shown, illustrating the hinged-lid feminine hygiene product dispenser. The exemplary embodiments according to the present device are illustrated with those components necessary to demonstrate the inventive design. [0025] FIG. 1 illustrates one embodiment of the assembled device from a perspective view having an open box shaped container 100 , constructed of a front panel 110 , a left panel 150 , a right panel 140 , a bottom panel 130 , a rear panel 120 , and a lid 160 . Said left panel 150 and right panel 140 are of a distance apart so as to accommodate a feminine hygiene product. The lid 160 , is of a longitudinal length greater than the bottom panel 130 and hingedly connects at hinge points 170 . Said hinge points 170 being located on the right panel 140 and left panel 150 , approximately along the axis of the long side of the rear panel 120 . The lid 160 being of a greater longitudinal length provides for an overhang 180 that when closed hangs over the front panel 110 , said overhang 180 makes for an easy surface to open and close the lid 160 . A further reason for the overhang 180 is to facilitate closing of the lid 160 in that the weight of the overhang 180 is sufficient enough to overcome the friction in the hinge points 170 , thus the lid 160 will self close once the user releases the lid 160 . FIG. 1 demonstrates the embodiment having the lid 160 in the open position. [0026] FIG. 2 illustrates the embodiment of FIG. 1 , having an open box shaped container 100 , constructed of a front panel 110 , a left panel 150 , a bottom panel 130 , a rear panel 120 , and a lid 160 . The lid 160 , is of a longitudinal length greater than the bottom panel 130 and hingedly connects at hinge points 170 . Said hinge point 170 being shown located on the left panel 150 , approximately along the axis of the long side of the rear panel 120 . The lid 160 being of a greater longitudinal length than the bottom panel 130 , provides for an overhang 180 that when closed hangs over the front panel 110 . By practice, applicant discovered that overhang 180 should be a width approximately the width of a finger, thus making for easy opening for users suffering from limited motility, arthritis, or other ailments preventing normal hand dexterity. [0027] To open the invention, a user would run her finger or edge of her hand up the front panel 110 and up against the overhang 180 underside surface. Applying easy pressure the lid 160 swingably opens exposing the feminine hygiene products for selection, when the pressure is removed the weight of the lid 160 and overhang 180 overcomes the friction in the hinge points 170 and the lid self closes. With the lid 160 closed, the feminine hygiene products are protected. [0028] FIG. 3 illustrates the embodiment of FIG. 1 , having an open box shaped container 100 , constructed of a front panel 110 , a right panel 140 , a bottom panel 130 , a rear panel 120 , and a lid 160 . The lid 160 , is of a longitudinal length greater than the bottom panel 130 and hingedly connects at hinge points 170 . Said hinge points 170 being shown located on the right panel 140 , approximately along the axis of the long side of the rear panel 120 . The lid 160 being of a greater longitudinal length than the bottom panel 130 , provides for an overhang 180 that when closed hangs over the front panel 110 . The hinge points 170 may be at any location on the rear panel 120 , right panel 140 or left panel 150 so as to allow for easy opening and closing of the lid 160 . [0029] FIG. 4 illustrates a top view of the embodiment of FIG. 1 , having an open box shaped container 100 , constructed of a front panel 110 , a right panel 140 , a left panel 150 , a bottom panel 130 , a rear panel 120 , and a lid 160 . The lid 160 is shown in the closed position. The lid 160 , is of a longitudinal length greater than the bottom panel 130 and hingedly connects at hinge points 170 . Said hinge points 170 being shown located on the right panel 140 , approximately along the axis of the long side of the rear panel 120 . The lid 160 being of a greater longitudinal length than the bottom panel 130 , provides for an overhang 180 that when closed hangs over the front panel 110 . The overhang 180 allows for an easy and accessible surface for opening the invention. [0030] FIG. 5 illustrates a bottom view of the embodiment of FIG. 1 , having an open box shaped container 100 , constructed of a front panel 110 , a right panel 140 , a left panel 150 , a bottom panel 130 , a rear panel 120 , and a lid 160 . The lid 160 is shown in the closed position. The lid 160 , is of a longitudinal length greater than the bottom panel 130 and hingedly connects at hinge points 170 . Said hinge points 170 being shown located on the right panel 140 , approximately along the axis of the long side of the rear panel 120 . The lid 160 being of a greater longitudinal length than the bottom panel 130 , provides for an overhang 180 that when closed hangs over the front panel 10 and can be clearly seen from the bottom view. In the illustrated embodiment the overhang 180 is of an elliptical arc shape, however the overhang 180 may be of any shape to match the aesthetic tastes of the user. [0031] FIG. 6 illustrates a rear view of the embodiment of FIG. 1 , having an open box shaped container 100 , constructed of a front panel 110 , a right panel 140 , a left panel 150 , a bottom panel 130 , a rear panel 120 , and a lid 160 . The lid 160 is shown in the closed position. The lid 160 , is of a longitudinal length greater than the bottom panel 130 and hingedly connects at hinge points 170 . The illustrated configuration allows for the hinge points 170 to be singular on each side, and could be constructed from a wooden dowel, a metal pin, or any other round object that the lid 160 could pivot on. The rear panel 120 can also be used as a hinge point 170 so long as the hinging method makes for an easy to open lid 160 . [0032] FIG. 7 illustrates a front view of the embodiment of FIG. 1 , having an open box shaped container 100 , constructed of a front panel 110 , a right panel 140 , a left panel 150 , a bottom panel 130 , and a lid 160 . The lid 160 is shown in the closed position. The lid 160 , is of a longitudinal length greater than the bottom panel 130 and hingedly connects at hinge points 170 . In the illustrated embodiment, the lid 160 fittingly inserts between the right panel 140 and left panel 150 , coming to rest on the front panel 120 . The illustrated configuration allows for the hinge points 170 to be singular on each side and approximately centered on the rear panel 120 and could be constructed from a wooden dowel, a metal pin, or any other round object that the lid 160 could pivot on. The rear panel 120 can also be used as a hinge point 170 so long as the hinging method makes for an easy to open lid 160 . [0033] The foregoing embodiments and advantages are merely exemplary and are not to be construed as limiting the present invention. Those skilled in the art can appreciate from the foregoing description that the techniques of the embodiments of the invention can be implemented in a variety of forms. For example, the hinge point 170 may be put anywhere so as to facilitate opening and closing of the lid. For another example, the lid 160 may either be between the left panel 150 and right panel 140 or in the alternative; the lid 160 could be on top of the left panel 150 and right panel 140 , having the front panel 110 and rear panel 120 being of greater width to compensate for the lid's 160 different location. Therefore, while the embodiments of this invention have been described in connection with particular examples thereof, the true scope of the embodiments of the invention should not be so limited since other modifications will become apparent to the skilled practitioner upon a study of the drawings, specification, and following claims.

1a

FIELD OF THE INVENTION The invention relates to a dispenser for repeatedly discharging a predetermined length of a continuous web of material, especially paper towels. PRIOR ART A number of dispensing devices are known in the art. Such dispensers serve for dispensing and cutting web material, including paper towelling, paper products and the like. With such dispensers, the processes of dispensing and cutting the web material are carried out automatically by pulling on the free or “tail” end of the web material that extends from the dispenser. The web material is taken from a feed roller and the action of pulling the web material causes the feed roller to rotate. The continuous web taken from the feed roller is directed to a cutting mechanism which is also driven by the pulling operation of the user. Such cutting mechanism cuts the continuous web at predetermined lengths. In many conventional dispensers, the cutting mechanism uses a cutting drum equipped with a blade which moves from a retracted position within the drum to an extended position once the drum reaches a predetermined rotational position to effect a cutting of the web material. U.S. Pat. No. 1,811,537 describes a dispenser holding a continuous roll of paper and severing the end of the web into sheets of predetermined lengths which are discharged one at a time. A knife is disposed within a groove extending longitudinally of a cutting drum. Spring means are provided for urging the knife outwards of the groove to severe a predetermined length of the web. A mechanism for cutting a web of flexible sheet material is known from U.S. Pat. No. 4,188,844. Such mechanism to be used in a dispenser has a feed roller and a pinch roller between which rollers the web passes. A knife is pivotally mounted in the feed roller to swing about an axis. The cutting edge of the knife projects outwardly beyond the periphery of the feed roller to cut the web as it passes over the feed roller. Cam followers are affixed to the knife and run in cam means which are stationarily mounted. The cam means have a cam surface engaged with the cam follower to swing the cam follower along an arcuate path in order to project the cutting edge of the knife upon rotation of the feed roller. A second cam surface engaging the cam follower serves to retract the cutting edge of the knife upon further rotation of the roller. Another example of a feed mechanism with a cam follower mechanism for operating a cutting knife is known from U.S. Pat. No. 5,048,386 and US 2007/0079676 A1. Such prior art dispensers require a relatively high pulling force which even can lead to the inadvertent tearing of the web in case of a relatively thin paper. This restricts the use of conventional dispensers to a specific type of material to be dispensed. EP 0 526 358 A1 discloses a dispenser with the pre-characterizing features of claim 1 . SUMMARY An object underlaying the invention is to provide a dispenser for repeatedly discharging a predetermined length of a continuous web of material which can be used for various types of material to be dispensed as well as different metered lengths of material. The dispenser for repeatedly discharging a predetermined length of a continuous web of material, especially paper towels, comprises a feed roller with the continuous web of material wound thereon, and a cutting drum incorporating a cutting device, the continuous web of material being directed in contact to at least part of the cutting drum. The dispenser is characterized in that the cutting device comprises at least two cutting knives with cutting blades, which cutting blades are operable between an active, extended position projecting beyond the outer circumferential surface of the cutting drum, and an inactive retracted position, wherein each cutting knife is provided with a cam follower engaging a stationary cam path of a camming mechanism. The dispenser has a cutting drum with at least two individual cutting knives at different positions of the circumferential direction of the cutting drum. This specific feature has several advantages. Since two or more individual cutting knives are placed along the circumferential direction of the cutting drum, either a shorter sheet length is possible or, when maintaining the same sheet length as is used with a cutting drum with one cutting knife only, it is possible to reduce the pull force required to operate the dispenser. The reduction of pull force is based on the general principle that the momentum effecting a rotation of the cutting drum linearly increases with increasing diameter of the cutting drum. Therefore, a larger cutting drum reduces the necessary pull force and, at the same time, a higher number of cutting knives can be placed along the circumferential direction of the cutting drum so as to provide for a desired sheet length dispensed. In other words, it is possible to select different lengths of paper depending on the number of cutting knives provided on the cutting drum. A further advantage of the dispenser lies in a controlled movement of the cutting device because each knife is provided with a cam follower engaging a stationary cam path of a camming mechanism. Such camming mechanism serves to generate a highly accurate movement of each knife. Further, the cutting drum incorporating a cutting device has two cutting knives which are positioned diametrically opposite to each other relative to the cutting drum. Such position of two cutting knives generates the same length of each paper towel. The dispenser, the cutting device of which has two cutting knives, further comprises an elastic means suitable to rotate into and hold the cutting drum in one of two distinct equilibrium positions. This specific feature serves to eject a paper tail for the next user. Once the paper web has been cut, the pulling force of a user can no longer be used to rotate the cutting drum and feed roller. Therefore, an internal means has to be provided in order to further move the cutting drum into a position so that a paper tail of the web to de dispensed can be grasped by the next user. Such further rotation can be best carried out by providing two distinct equilibrium positions of the cutting drum so that, after severing the web, the cutting drum rotates into the next of the two equilibrium positions. According to a preferred embodiment, the elastic means comprises two spring elements, both of which are attached at one end to a stationary part of the dispenser and at the other end to an attachment point off-axis relative to the longitudinal axis of the cutting drum and movable together with the rotation of the cutting drum. This is a simple means to provide an elastic means with two distinct equilibrium positions. The equilibrium positions are defined by the state in which the sum of the stretching forces of both spring elements are at a minimum. According to nature's law, each system seeks to come into a state of lowest energy so that the cutting drum, after cutting the web, will automatically rotate into the next position which provides a minimum value of the overall energy. Such system using two spring elements can be adjusted such that the rotation of the cutting drum will be in the right direction in order to feed the paper tail for the next user. Further, spring elements have a small friction so that the cutting drum will not become stuck at some undesirable intermediate position because high friction forces cannot be overcome when rotating into the equilibrium state. Further, such system using two spring elements only requires a small number of parts so that such mechanism can be manufactured at low costs and is easy to assemble. According to a preferred embodiment, the diameter of the cutting drum is from 120 mm to 210 mm, preferably around 140 mm. The advantage of such selection of diameter is a low pull force required because of a higher momentum. The larger diameter also enables a suitable sheet length even when each sheet is only half the circumference, instead of as in earlier such dispensers where one sheet is one full circumference. Further, a low cutting force is possible since, with a cutting drum of a diameter of at least 120 mm, a lot of space is available to operate the cutting knives via long levers. If a diameter of the cutting drum of 210 mm is selected, three cutting knives can be distributed over the perimeter of the cutting drum. Preferably, the feed roller is positioned such as to abut the cutting drum. Such design reduces the space required inside the dispenser. Such space can be used to increase the diameter of the cutting drum. Further, no separate braking mechanism is necessary because the rotation of the feed roller is stopped by the cutting drum once the cutting drum has been rotated into one of the equilibrium positions. According to a preferred embodiment, the cutting blade of each cutting knife has two main surfaces and an edge portion, wherein in the inactive, retracted position of the cutting knives, one main surface of each cutting blade essentially follows the outer circumferential surface of the cutting drum. In other words, in the inactive, retracted position of the cutting blades, the slot formed in the cutting drum for holding the cutting knife is essentially closed. As a result of this, there are no gaps in the cutting drum except in those position where the cutting knife is in its active, extended position projecting beyond the outer circumferential surface of the cutting drum. When such position of the cutting knife in the inactive, retracted position is used in combination with a feed roller positioned such as to abut the cutting drum, no bumping effect occurs. This means that the feed roller runs smoothly over the circumferential surface of the cutting drum since one main surface of each cutting blade essentially closes the gap formed in the cutting drum. As a result of this, the noise generated between the feed roller and the cutting drum when operating the dispenser can be reduced. Preferably, the dispenser is further characterized by two camming mechanisms, one camming mechanism being positioned at each longitudinal end of the cutting drum. The specific advantage of this feature is a good, controlled movement of the knives since, in case of two knives, these can be simultaneously operated from both longitudinal sides of the cutting drum. Further, the controlled movement also contributes to a low pulling force required to operate the dispenser. According to an alternative embodiment of the invention, each of two cutting knives can be operatively connectable to a different camming mechanism. If such design is used, there is increased flexibility as to which knife follows which of the cam paths. This opens up the possibility to provide alternating sheet lengths or to select long or short sheets depending on the position and design of the two camming mechanisms. BRIEF DESCRIPTION OF THE DRAWINGS In the following, embodiments of the invention will be briefly described by way of example with reference to the accompanying drawings in which: FIG. 1 shows a part of a dispenser and the relative position of a feed roller and a cutting drum; FIG. 2 shows a part of the dispenser and especially its cutting drum; FIG. 3 shows an end surface of a cutting drum with two cutting knives and a camming mechanism; FIG. 4 schematically explains the sequence of the rotational movement of the cutting drum and its related position of two cutting knives; and FIG. 5 shows the mechanism for ejecting a paper tail for the next user after cutting the paper web. DESCRIPTION OF PREFERRED EMBODIMENTS In the following, throughout the drawings, the same elements will be denoted by the same reference numerals. FIG. 1 shows a part of a dispenser 10 and especially the rear side 12 of its housing which can be affixed e.g. to a wall. The housing 12 is usually made of a hard plastic material. The housing mainly contains a feed roller 14 equipped with a continuous web of e.g. paper with a high absorbency which could be used in public rest rooms. The feed roller 14 is held by a mounting bracket 16 which is pivotally attached to the housing and can be biased by means of springs 18 (as shown in FIG. 2 ) but also by gravity into such a position that feed roller 14 always abuts against and slightly urges against cutting drum 20 positioned below feed roller 14 . The cutting drum 20 has a relatively large diameter from 120 mm to 150 mm and preferably around 140 mm. In operation, a continuous web is removed from feed roller 14 , runs between feed roller 14 and cutting drum 20 and partly around cutting drum 20 in order to leave the dispenser 10 in a position below the cutting drum 20 . When a user grasps the web and pulls the tail end of the web, this pulling force generates a rotation of the cutting drum 20 and, correspondingly, of the feed roller 14 . Depending on the amount of material wound on the feed roller, the rotational speed of the feed roller 14 and cutting drum 20 differ from each other. However, the circumferential rotational speed of both rollers is the same. During the rotation of the cutting drum, the paper web is cut to a suitable length so that the user receives a metered length of the web material. As will be described later, the dispenser continuous the rotational movement even without the pulling force of a user in order to eject a tail end of the web for being grasped by the next user. FIG. 2 shows in more detail the cutting drum 20 of the dispenser and its associated parts. The feed roller 14 is not shown in FIG. 2 but the mounting bracket 16 and the biasing spring 18 are shown. The cutting drum has a cylinder shape. On its circumferential surface, there can be provided numerous projections 22 which are slightly elevated over the circumferential surface of the cutting drum. Such projections 22 serve to reduce the contact area between the material to be dispensed and the cutting drum. Such reduction of the contact surface has the effect that the electrostatic charging of the web to be dispensed and of the dispenser is reduced. FIG. 2 also shows a cutting knife 24 which is provided with a blade 26 with a cutting edge 28 , the cutting edge having several teeth 30 . However, the invention is not restricted to such shape of the cutting knife 24 and any other shape is also possible as long as the web material to be cut and dispensed can be properly severed. As can be seen from FIG. 2 , the cutting knife 24 is in such a position that the blade 26 roughly follows the circumferential surface of the cutting drum 20 . The cutting knife 24 is attached to a knife lever 32 , the function of which will be described in more detail by means of the following drawings. Paper dispensed from a feed roller runs around the cutting drum 20 , turns near the lowermost point of the cutting drum and leaves the dispenser at tray 34 where the user can grasp it and pull the web to be dispensed. FIG. 3 shows the longitudinal end of cutting drum 20 in which the side panel 36 as shown in FIG. 2 has been removed. From FIG. 3 it follows that the cutting drum as shown therein is provided with two cutting knives both of which are fixedly attached to a knife lever 32 . From FIG. 3 it can be seen that the two cutting knives are arranged on the cutting drum diametrically opposite to each other. This leads to a cutting operation where each sheet to be dispensed has the same length. However, it is also possible to select a different position of the cutting knives relative to each other or to provide more than two cutting knives which is possible by providing different camming mechanisms at both longitudinal sides of the cutting drum and to connect selected cutting knives to either the first or the second camming mechanism. The camming mechanism 40 is only generally shown in FIG. 3 and will be explained in more detail by means of FIG. 4 . The camming mechanism 40 comprises a camming plate 42 , the rear side of which is shown in FIG. 3 . The opposite side serves as the front side and is provided with a camming slot which is engaged by camming elements fixed to the knife levers, respectively. In order to show the operation of the camming mechanism, FIG. 4 shows a sequence of individual rotational positions of the cutting drum with the position of camming elements 44 at both knife levers 32 . The camming element 44 of each knife lever 32 runs along a camming slot 46 , which is provided in the front side of camming plate 42 and for which only the center line of the camming slot is shown in FIG. 4 . Accordingly, the center line of the camming slot 46 runs through the center of the circular camming elements 44 . The camming plate 42 is at a fixed position relative to the housing of the dispenser so that upon rotation of the cutting drum 20 , the knife levers are moved in a predetermined and controlled way because the camming elements fixed to the knife levers 32 are forced along the camming slot 46 . In the position as shown in FIG. 4( a ), both knife levers 32 are in the position as shown in FIG. 3 . In this state, each cutting knife is arranged such as to cover the knife slot 45 . In this position, one main surface of the blade covers the knife slot 45 so that there are essentially no slots in the outer circumferential surface of cutting drum 20 . When the cutting drum is rotated further into position (b) by a clockwise movement in the plane of FIG. 4 , the cutting knife 24 fixedly attached to knife lever 32 a is still in the inactive retracted position, whereas cutting knife 24 b attached to knife lever 32 b is on the way into the active, extended position. Cutting knife 24 b already extends beyond the outer circumferential surface of the cutting drum 20 . When a further rotational movement in clockwise direction up to the position in FIG. 4( c ) has taken place, cutting knife 24 a is still in the inactive position whereas cutting knife 24 b is now fully extended and in its cutting position in which the web material is severed. When a further rotational movement is carried out up to the position as shown in FIG. 4( d ), cutting knife 24 b has already returned to some extent in direction of arrow A into its retracted position. When a further rotation of the cutting drum 20 is carried out, the situation will resemble again that as shown in FIG. 4( a ) with the only difference that it is now cutting knife 24 a which will start in the further progress of rotation to reach the cutting region 50 of the camming slot in which the knife will extend into its active position so as to cut the web of material. Once the web has been cut, the further rotation of the cutting drum can no longer be effected in reaction to the pulling force of a user. Therefore, a mechanism has to be provided so that the cutting drum rotates into a suitable position in which the end of the web to be dispensed is ejected far enough onto the tray so that the next user can grasp and pull again the tail of the web. In order to achieve this function a lever arm 52 is fixed to the cutting drum 20 . This lever arm 52 rotates together with the drum. It provides an off-center attachment position 54 which serves to attach the first end 56 ( a ) of a spring element 56 . When the cutting drum is rotated, the first ends 56 a of the spring elements 56 change their position. The second ends 56 b of the spring elements 56 are affixed to a suitable attachment means 58 , the position of which is fixed relative to the housing of the dispenser. Therefore, when the cutting drum is rotated, the first ends 56 a of the spring means change their position together with the lever arm 52 , whereas the second ends 56 b of the spring element 56 remain fixed relative to the dispenser. Therefore, by selecting the geometry two distinct equilibrium states can be achieved which are shown in FIG. 5 . In both these equilibrium states, the spring elements 56 have the least tensioning energy so that, provided that the friction of the rotating drum is sufficiently low, the rotating drum 20 will move into the closest of the two equilibrium states as shown in FIG. 5 . The two equilibrium positions as shown in FIG. 5 follow the specific embodiment described with two cutting knives which are diametrically opposite to each other on the cutting drum. However, when using three elastic elements, it is likewise possible to define three distinct equilibrium states. It should be noted that the accuracy of the equilibrium positions need not to be high. It is sufficient that the tail end of the web is further transported to an extent that the next user can comfortably grasp the end of the web. Small positional deviations when reaching the equilibrium state of a few millimeters are not decisive. The inventive dispenser has the advantage that, due to the large diameter of the cutting drum, the pull force can be kept low. The camming mechanism provides for an accurate and controlled movement of the knives and the further mechanism to further rotate the cutting drum into a near-by equilibrium position makes it possible to eject the paper tail for the next user. The camming mechanism further allows to provide a movement such that, in the inactive, retracted position of the knife, the blades of the knife follow the circumferential surface of the cutting drum. In such a way, no sharp edges are accessible for the user or service personnel in order to minimize the risk of injuries. The larger diameter of the cutting drum also makes it possible to mount the cutting knives to relatively long knife levers. This makes it possible to generate high cutting forces. If, as shown in the specific embodiment, the dispenser roll is in direct contact to the cutting drum, no separate braking mechanism is necessary which reduces the number of components of the dispenser and makes it easier to assemble. The provision of at least two cutting knives makes it possible to realize a shorter length of the individual sheets to be dispensed. If the knives are operated from different sides of the cutting drum, respectively, it is possible to make one knife inoperable. In such a case it is easily possible to select different lengths of paper. Because of the low pulling force required, also relatively thin paper webs can be safely used in the inventive dispenser.

1a

This application is a continuation of U.S. application Ser. No. 09/986,060, filed Nov. 7, 2001 now abandoned, which is a continuation of PCT/IE00/00057, filed May 8, 2000, and is a continuation-in-part of U.S. application Ser. No. 09/188,472, filed Nov. 9, 1998, now U.S. Pat. No. 6,336,934, the contents of each of these applications are incorporated herein by reference. This invention relates to a filter element for a transcatheter embolic protection device. INTRODUCTION The invention is particularly concerned with filter elements for transcatheter embolic protection devices of the type described in our WO-A-9923976. One type of such embolic filter essentially comprises a filter body mounted on an associated collapsible support frame which can be collapsed against the guidewire by means of a catheter for deployment of the filter through a patient's vascular system. Upon retraction of the catheter the support frame and filter body expand outwardly from the guidewire across a blood vessel within which the filter is positioned to filter blood flowing through the blood vessel. One problem with the filter device is that there is a guidewire tip on the distal end which is required for guiding the filter into a desired position. The guidewire tip needs to be relatively long to provide a smooth tip transition. However, the guidewire distal tip may interfere with the optimal placement of the filter element. The present invention is directed towards overcoming this problem. STATEMENTS OF INVENTION According to the invention there is provide a medical guidewire assembly comprising: guidewire having a flexible tip at a distal end of the guidewire; a medical device mounted near the distal end of the guidewire proximally of the tip, the medical device being movable relative to the tip for adjustment of the amount of the tip extending distally of the medical device; and means to limit the movement of the medical device relative to the tip. In a preferred embodiment of the invention the means to limit the movement of the medical device comprise one or more stiff limiting elements. Preferably at least one limiting element is provided on the guidewire. The limiting element may be fixedly mounted to the guidewire. Alternatively, the limiting element is slidably mounted on the guidewire. In this case preferably the assembly includes stop means to limit slidable movement of the limiting element relative to the guidewire. The stop means to limit slidable movement of the limiting element preferably comprises a pair of stops spaced axially apart along the guidewire. The stops may be provided by abutment surfaces formed in the guidewire. In a preferred embodiment of the invention at least one limiting element is mounted to the medical device. Preferably the limiting element is mounted to the medical device at the proximal end of the medical device. In one arrangement the limiting element is mounted intermediate proximal and distal ends of the medical device. In one embodiment of the invention at least one limiting element is stiff relative to the guidewire. Alternatively or additionally at least one limiting element is compliant relative to the guidewire. Preferably the medical device and the tip are slidable relative to each other. Ideally, the medical device has a receiver slot for reception of at least portion of the tip. In one embodiment of the invention the tip is fully retractable within the receiver slot. In a particularly preferred embodiment of the invention the medical device is a collapsible embolic filter mounted on a tubular sleeve which is slidably mounted on the guidewire adjacent the distal end of the guidewire, the sleeve having a bore through which the guidewire passes, said bore forming a receiver slot for reception of the flexible tip of the guidewire which is at least partially retractable within the bore of the sleeve. Preferably the tip is fully retractable within the bore of the sleeve. In one embodiment a guidewire limiting element is mounted to the guidewire proximal of the embolic filter and a filter limiting element is mounted to the filter within the bore of the sleeve, the guidewire being movable relative to the filter between the first and second limiting elements. In this case preferably the guidewire has an abutment which is engagable with the filter limiting element when the guidewire tip is retracted. In one embodiment the abutment is provided by a shoulder of the tip. In one arrangement the filter limiting element is provided at a proximal end of the filter. In another arrangement the filter limiting element is provided intermediate proximal and distal ends of the filter. In another embodiment of the invention a guidewire limiting element is mounted to the guidewire intermediate proximal and distal ends of the filter and the filter has a proximal filter limiting element and a distal filter limiting element, the guidewire limiting element being movable with the guidewire between the proximal and distal filter limiting elements. In one case the guidewire tip is retractable proximally of the distal filter limiting element. Preferably the guidewire limiting element is movable on the guidewire. In this case the assembly includes stop means to limit slidable movement of the guidewire limiting element relative to the guidewire. The stop means may comprise a pair of stops spaced axially apart along the guidewire. The stops may be provided by abutment surfaces formed in the guidewire. In one embodiment the guidewire has a recessed portion of reduced diameter on which the guidewire limiting element is mounted. In another aspect the invention provides an embolic protection device comprising: a collapsible filter element mounted on a filter carrier for delivery through a vascular system of a patient; the filter element being movable between a collapsed stored position against the filter carrier for movement through the vascular system, and an expanded position for occluding a blood vessel such that blood passing through the blood vessel is delivered through the filter element; the filter element comprising a collapsible filter body having an inlet end and an outlet end; the inlet end of the filter body having one or more inlet openings sized to allow blood and embolic material enter the filter body; the outlet end of the filter body having a plurality of outlet openings sized to allow through passage of blood but to retain undesired embolic material within the filter body; the collapsible filter element being slidably mounted on the filter carrier for axial movement of the filter element along the filter carrier; and means to limit the movement of the filter element relative to the filter carrier, the means being arranged to allow a distal end of the filter carrier to be substantially retracted into the filter element. In one embodiment of the invention the means to limit the movement of the filter element comprise one or more limiting elements. At least one limiting element is preferably provided on the filter carrier. The limiting element may be fixedly mounted on the filter carrier. Alternatively the limiting element is slidably mounted on the filter carrier. In this case the device preferably includes stop means to limit the movement of the limiting element relative to the filter carrier. The means to limit the movement of the limiting element may comprise a pair of stops spaced axially apart along the filter carrier. The stops may be provided by abutment surfaces formed on the filter carrier. In a preferred embodiment of the invention at least one limiting element is mounted to the filter element. The limiting element may be mounted to the filter element intermediate the proximal and distal ends of the filter element. In one embodiment of the invention at least one limiting element is stiff relative to the filter carrier. Alternatively or additionally at least one limiting element is compliant relative to the filter carrier. The limiting element may be mounted to the filter element at the proximal end of the filter element. In a particularly preferred embodiment of the invention the filter carrier is a guidewire. Preferably the distal end of the guidewire includes a guiding tip which may be substantially retracted into the filter element. The invention also provides a method for positioning a medical device in a body lumen comprising the steps of: providing a medical guidewire assembly of the invention; advancing the assembly into a body lumen with the guidewire tip extending distally of the medical device to a first location; moving the medical device relative to the tip to advance the medical device to a second location which is distally advanced from the first location. BRIEF DESCRIPTION OF THE DRAWINGS The invention will be more clearly understood by the following description of some of the embodiments thereof, given by way of example only, with reference to the accompanying drawings, in which: FIG. 1 is partially sectioned elevational view of an embolic protection device; FIG. 2 is a schematic sectional elevational view of the embolic protection device of FIG. 1 ; FIG. 3 is a detail sectional view of a portion of the device of FIG. 1 ; FIG. 4 is a longitudinal cross sectional view of the device of FIG. 1 ; FIG. 5 is a cross sectional view of a distal end of the device of FIG. 1 ; FIG. 6 is a view on the line A-A in FIG. 4 ; FIG. 7 is a perspective view of a filter body of the device of FIGS. 1 to 6 ; FIG. 8 is a side elevational view of the filter body of FIG. 7 ; FIG. 9 is a view on a proximal end of the filter body; FIG. 10 is a perspective view of a support frame of the device of FIGS. 1 to 6 ; FIG. 11 is a side elevational view of the support frame; FIG. 12 is a perspective view illustrating the manufacture of the support frame; FIG. 13 is a view of the support frame and filter body assembly; FIG. 14 is a side partially cross sectional view of a filter body and guidewire according to one embodiment of the invention in one position of use; FIG. 15 is a side view similar to FIG. 14 in another position of use; FIG. 16 is a side, partially cross sectional view of a filter body and guidewire according to another embodiment of the invention in one position of use; FIG. 17 is a side view similar to FIG. 16 in another position of use; FIG. 18 is a side partially cross sectional view of a filter body and guidewire according to a further embodiment of the invention in one position of use; FIGS. 19 and 20 are side views similar to FIG. 18 in other positions of use; and FIGS. 21 to 23 are side, partially cross sectional views of a filter body and guidewire according to a further embodiment of the invention in different positions of use. DETAILED DESCRIPTION Referring to FIGS. 1 to 13 there is illustrated an embolic protection device as described in our WO-A-9923976 indicated generally by the reference number 100 . The device 100 has a guidewire 101 with a proximal end 102 and a distal end 103 . A tubular sleeve 104 is slidably mounted on the guidewire 101 . A collapsible filter 105 is mounted on the sleeve 104 , the filter 105 being movable between a collapsed stored position against the sleeve 104 and an expanded position as shown in the drawings extended outwardly of the sleeve 104 for deployment in a blood vessel. The sleeve 104 is slidable on the guidewire 101 between a pair of spaced-apart end stops, namely an inner stop 106 and an outer stop which in this case is formed by a spring tip 107 at the distal end 103 of the guidewire 101 . The filter 105 comprises a filter body 110 mounted over a collapsible support frame 111 . The filter body 110 is mounted to the sleeve 104 at each end, the body 110 being rigidly attached to a proximal end 112 of the sleeve 104 and the body 110 being attached to a collar 115 which is slidable along a distal end 114 of the sleeve 104 . Thus the distal end of the body 110 is longitudinally slidable along the sleeve 104 . The support frame 111 is also fixed at the proximal end 112 of the sleeve 104 . A distal end 116 of the support frame 111 is not attached to the sleeve 104 and is thus also free to move longitudinally along the sleeve 104 to facilitate collapsing the support frame 111 against the sleeve 104 . The support frame 111 is such that it is naturally expanded as shown in the drawings and can be collapsed inwardly against the sleeve 104 for loading in a catheter 118 or the like. The filter body 105 has large proximal inlet openings 117 and small distal outlet openings 119 . The proximal inlet openings 117 allow blood and embolic material to enter the filter body, while, the distal outlet openings 119 allow through passage of blood but retain undesired embolic material within the filter body. An olive guide 120 is mounted at a distal end of the sleeve 104 and has a cylindrical central portion 121 with tapered ends 122 , 123 . The distal end 122 may be an arrowhead configuration for smooth transition between the catheter and olive surfaces. The support frame 111 is shaped to provide a circumferential groove 125 in the filter body 110 . If the filter is too large for a vessel, the body may crease and this groove 125 ensures any crease does not propagate along the filter. Enlarged openings are provided at a proximal end of the filter body 110 to allow ingress of blood and embolic material into an interior of the body 110 . In use, the filter 105 is mounted in a collapsed state within a distal end of the catheter 118 and delivered to a deployment site. When the filter is correctly positioned the catheter 118 is retracted allowing the support frame 111 to expand expanding the filter body 110 across the vessel in which the filter is mounted. Blood and emboli can enter the enlarged openings at a proximal end of the filter body 110 . The blood will pass through the filter body, however, the openings or pores in the filter body are sized so as to retain the embolic material. After use, a retrieval catheter 18 is delivered along the guidewire 101 and slid over the filter 105 engaging the proximal inlet end 112 first to close the openings and then gradually collapsing the filter body against the sleeve 104 as the catheter 118 advances over the filter 105 . Once the filter 105 is fully loaded in the catheter 118 , it can then be withdrawn. It will be noted that a proximal end of the filter is fixed and a distal end of the filter is longitudinally movable along the sleeve to facilitate collapsing of the filter body. Further, the catheter engages the proximal end of the filter body first thus closing the filter body inlet and preventing escape of embolic material from the filter body as the filter body is being collapsed. The outer filter body 110 is preferably of a resilient biocompatible elastomeric material. The material may be a polyurethane based material. There are a series of commercially available polyurethane materials that may be suitable. These are typically based on polyether or polycarbonate or silicone macroglycols together with diisocyanate and a diol or diamine or alkanolamine or water chain extender. Examples of these are described in EP-A-461,375 and U.S. Pat. No. 5,621,065. In addition, polyurethane elastomers manufactured from polycarbonate polyols as describe U.S. Pat. No. 5,254,622 (Szycher) are also suitable. The filter material may also be a biostable polycarbonate urethane article example of which may be prepared by reaction of an isocyanate, a chain extend and a polycarbonate copolymer polyol of alkyl carbonates. This material described in our WO-A-9924084. The filter material may be manufactured from a block and cut into a desired shape. However the filter is preferably formed by dipping a rod of desired geometry into a solution of the material which coats the rod. The rod is then dissolved. The final geometry of the filter may be determined in the dipping step or the final geometry may be achieved in a finishing operation. Typically the finishing operations involve processes such as mechanical machining operations, laser machining or chemical machining. The filter body is of hollow construction and is formed as described above by dipping a rod in a solution of polymeric material to coat the rod. The rod is then dissolved, leaving a hollow body polymeric material. The rod may be of an acrylic material which is dissolved by a suitable solvent such as acetone. The polymeric body thus formed is machined to the shape illustrated in FIGS. 1 to 13 . The final machined filter body comprises an inlet or proximal portion 210 with a proximal neck 212 , and outlet or distal portion 213 with a distal neck 214 , and an intermediate portion 215 between the proximal and distal portions. The inlet holes 117 are provided in the proximal portion 210 which allow the blood and embolic material to flow into the filter body. In this case the proximal portion 210 is of generally conical shape to maximise the hole size. The intermediate portion 215 is also hollow and in this case is of generally cylindrical construction. This is important in ensuring more than simple point contact with the surrounding blood vessel. The cylindrical structure allows the filter body to come into soft contact with the blood vessel to avoid damaging the vessel wall. The intermediate portion 215 is provided with a radial stiffening means, in this case in the form of a radial strengthening ring or rim 220 . The ring 220 provides localised stiffening of the filter body without stiffening the material in contact with the vessel. Such an arrangement provides appropriate structural strength so that line apposition of the filter body to the vessel wall is achieved. It is expected that other geometries of stiffening means will achieve a similar result. The tubular intermediate portion 215 is also important in maintaining the stability of the filter body in situ to retain captured emboli and to ensure that flow around the filter is minimised. For optimum stability we have found that the ratio of the axial length of the intermediate portion 215 of the filter body to the diameter of the intermediate portion 215 is preferably at least 0.5 and ideally greater than 1.0. The collapsible support frame 111 has four foldable arms 290 which are collapsed for deployment and upon release extend outwardly to expand the filter body 110 . The support frame 111 can be manufactured from a range of metallic or polymeric components such as a shape memory alloy like nitinol or a shape memory polymer or a shaped stainless steel or metal with similar properties that will recover from the deformation sufficiently to initiate opening of the filter body 110 . The support frame may be formed as illustrated in FIG. 12 by machining slots in a tube 291 of shape memory alloy such as nitinol. On machining, the unslotted distal end of the tube forms a distal collar 293 and the unslotted proximal end of the tube forms a proximal collar 294 . In use, the distal collar 293 is slidably moveable along the tubular sleeve 104 which in turn is slidably mounted on the guidewire 101 for deployment and retrieval. The proximal collar 294 is fixed relative to the tubular sleeve 104 . To load the filter the sub assembly of the support frame and filter body is pulled back into the catheter 118 to engage the distal stop 107 . The support arms 290 are hinged inwardly and the distal collar 293 moves forward along the tubular sleeve 104 . As the support arms 290 enter the catheter 118 the filter body 110 stretches as the filter body collar 115 slides along the tubular sleeve 104 proximal to the olive 120 . On deployment, the catheter 118 is retracted proximally along the guidewire 101 initially bringing the collapsed filter assembly with it until it engages the proximal stop 106 . The catheter sleeve then begins to pull off the filter, freeing the support arms 290 to initiate opening of the filter body to appose the vessel wall. For retrieval, a retrieval catheter is introduced by sliding it over the guidewire 101 until it is positioned at the proximal end of the filter body and support frame. Pulling the guidewire 101 will initially engage the distal stop 107 with the filter element and begin to pull it into the retrieval catheter. The initial travel into the delivery catheter acts to close the proximal openings of the filter element, thus entrapping the embolic load. As the filter continues to be pulled back the filter body and the support frame are enveloped in the retrieval catheter. The collapsed filter may then be removed from the patient. Referring to FIGS. 14 and 15 there is illustrated a medical guidewire assembly according to one embodiment of the invention. A filter 31 is mounted on a guidewire 30 and projecting from the distal end of the guidewire 30 is a guidewire tip 32 . The guidewire tip 32 is slidable in a bore 38 in a sleeve 39 of the filter 31 . When the filter 31 is being manoeuvred into place the guidewire tip 32 facilitates the manoeuvring of the filter device. By advancing and retracting the tip 32 relative to the filter assembly 31 it is possible to manoeuvre the guidewire tip 32 around various portions of the anatomy, for example, where it is particularly tortuous, or where the guidewire tip 32 has to cross lesions. The tip 32 can be partially retracted to give a stiffer tip, or can be fully retracted in the deployment position, FIG. 15 . The guidewire 30 is slidable between a proximal guidewire limiting element 35 on the guidewire 30 and a filter limiting element 37 provided at a proximal end of the filter 31 . A stop defined by a shoulder 36 of the tip 32 is engagable against the limiting element 37 . The proximal limiting element 35 and the filter limiting element 37 are of a relatively stiff material, such that upon engagement of the filter 31 with the proximal limiting element 35 , or the shoulder 36 with the filter limiting element 37 , the limiting elements 35 , 37 do not deform. In this way the movement of the filter 31 relative to the guidewire tip 32 is accurately controlled. One or both of the limiting elements 35 , 37 may be of a compliant material. This feature will assist in ensuring that the flexibility of the filter is not affected by the limiting elements. Referring to FIGS. 16 and 17 there is illustrated a medical guidewire assembly including a filter 42 , which is similar to the filter 31 of FIGS. 14 and 15 , and the same reference numerals are used to denote similar elements in FIGS. 16 and 17 . In this case the guidewire 30 is slidable between a proximal limiting element 35 on the guidewire 30 and a filter limiting element 40 positioned intermediate the proximal and distal ends of the filter 42 . A distal stop defined by a shoulder 36 of the tip 32 is engagable against the filter limiting element 40 . Referring to FIGS. 18 to 20 there is illustrated a medical guidewire assembly including a filter 50 , which is similar to filters 31 and 42 of FIGS. 14 to 17 , and the same reference numerals are used to denote similar elements in FIGS. 18 to 20 . In this arrangement a guidewire limiting element 51 is rigidly fixed to the guidewire 30 proximal of the tip 32 , the filter 50 being mounted on the guidewire 30 so that the limiting element 51 is intermediate the proximal and distal ends of the filter 50 . The guidewire 30 is slidable between a distal limiting element defined by a proximal shoulder 53 of the filter 50 which is engagable against the guidewire limiting element 51 , and a proximal limiting element defined by a distal shoulder 52 of the filter 50 which is engagable against the guidewire limiting element 51 . In this arrangement there is no obstruction to advancement of another medical device over the guidewire 30 to approach the filter 50 from the proximal direction. Referring to FIGS. 21 to 23 in an alternative embodiment of the invention, the guidewire limiting element 51 is slidably mounted within a recess 53 provided on the guidewire 30 , the movement of the limiting element 51 relative to the guidewire 30 being limited between a proximal stop provided by a shoulder 55 of the recess and a distal stop provided by a shoulder 54 provided by the guidewire tip 32 . This arrangement provides an even greater degree of freedom for movement of the guidewire 30 relative to the filter. The filter may be placed over or beyond the distal guidewire tip. Thus, the invention facilitates the optimal placement of a filter device in the limited vasculature space available. Other medical devices may be advanced over the guidewire to approach the filter from the proximal direction without obstruction. Such devices may be for use in performing angioplasty procedures, stenting and the like. Ready access is also provided to perform emergency procedures such as snaring of a medical device or part, and lysis for treatment of a blood clot. It will be appreciated that while the invention has been described in relation to an embolic protection device it may also be applied to medial guidewire assemblies for placement of other medical devices. The invention is not limited to the embodiments hereinbefore described which may be varied in both construction and detail.

1a

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] The present invention relates to a fusion protein, more particularly, to a fusion protein for inhibiting cervical cancer induced or caused by HPV type 16 and pharmaceutical compositions thereof. [0003] 2. Description of Related Art [0004] Currently, the incidence ratio of cervical cancer has remained high among all woman cancer patients. There are no any obvious symptoms of general variation of cervical epithelium or early cervical cancer. Although cervical cancer can be successfully treated in its early stages, prevention is still much better than treatment. Therefore, the researchers in this field have been making effort to find out the most efficient way to prevent cervical cancer. [0005] It is already proved that human papillomavirus, HPV is highly related with cervical cancer. Some types (e.g. type 16, or 18) of DNA sequence of HPV had been found in cervical cancer cells, about 75%˜100%, but it is still not clear what the mechanism is in causing the cancer. Lately, research has found that the early gene product of virus—protein E6 and E7 of highly dangerous type 16, 18 and 31 of HPV easily combines with the product of genes Rb and p53 and thus reduce the ability of anti-tumor agent. This explains that HPV is not functioning alone when causing cancer but is assisted by environmental factors. Moreover, E7 protein expresses continuously in cervical cancer cells and carcinoma tissues. E7 protein also plays an important role in the process of maintaining shifted malignant tissue phenotype. [0006] The cancer immune therapy is mainly displayed with cell-mediated immunization, assisted by humoral immunization. Cells involved in cell-mediated immunization are cytotoxic T lymphocytes (CTL), NK and macrophages. CTL is triggered by interlukin-2, and then identified by T cells. The major histocompatibility complex (MHC) on the cancer cells with antigen present appears and releases lysozyme to destroy the cancer cells and restrain the proliferation of cancer cells. CTL protection is proved to inhibit cancers caused by HPV. Therefore if it is possible to induce the proliferation of the HPV-antigen-specific CTL, for example, CD 8 + T lymphocytes, by enhancing complexes of HPV antigen and MHC class I presenting on cancer cells, the strategy of CTL induction with E7 antigen can be able to control carcinoma cell directly and beneficial for immunological prevention and treatment. [0007] It is proved by research that cervical cancer is able to be prevented by vaccine injection. E7 proteins of HPV are highly common in carcinoma tissues or the tissues before carcinoma damage, therefore, E7 protein has the potential for developing as a vaccine. Basically, HPV type 16 and HPV type 18 are serious causes of not only cervical cancer, they are also dangerous factors for inducing lung cancer in females. The carcinogenic proteins E6 and E7 can be transferred to lungs through the circulation of blood and they decompose the anti-tumor proteins produced by gene Rb and p53. Once the anti-tumor genes or the proteins produced by them are deactivated, cancer cells show up. Though the present DNA vaccine does have a long term effect, on the other hand, it has high production costs. The main factor of restrained development in the DNA vaccine is the highly dangerous nature of the virus itself, which mutates easily. Furthermore, when applying E7 protein in gene therapy to cervical cancer, the induced immune response is usually induced weakly because of the weak antigen character of E7 protein of HPV virus. The effect of the prophylaxis and the therapy of cervical cancer are not able to be evaluated because of frail immune response. [0008] Generally, the specific antigen of cancer cells needs to be modified and combined with MHC-I then presented to the cell surface in order to trigger the CD8 + cells and elicit cell-mediated system. The research shows that the HPV type 16 E7 gene can be found in cervical cancer tissues but there is a lack of the specific MHC-I complex to present to the cell surface for showing E7 antigen. Therefore, HPV type 16 E7 protein will not be present to or initiate the cellular immune system of the host cell and then HPV escapes from the detection or monitoring of host. Usually, when E7 protein is injected in vivo, it is considered as external antigens. The E7 vaccination can only be induced the humor immune response thus lowering the effect to elicit cell-mediated immunity. Hence, it is necessary to develop a transportation system of sending the intact foreign protein into cytoplasm and induce effective immune response. [0009] Therefore, it is desirable to provide an fusion protein for inhibiting cervical cancer to mitigate and/or obviate the aforementioned problems. SUMMARY OF THE INVENTION [0010] A fusion protein for inducing immune response of specific cancers is disclosed, especially to some weak antigen viruses, which do not easily induce immune response. The fusion protein of the present invention can effectively inhibit the proliferation of carcinoma cells and lower the carcinoma level, and moreover can to prevent cancers. [0011] The fusion protein of the present invention is able to induce CTL and antibody protection in vivo, then further is able to destroy the infected cells by presenting the antigen. A pharmaceutical composition for preventing or inhibiting cancer cells induced by human papillomavirus type 16 is also disclosed in the present invention. The pharmaceutical composition of the present invention also comprises a medical compound such as a fusion protein for preventing or inhibiting cancer induced by human papillomavirus type 16, wherein the compound is able to control the proliferation or the increase of carcinoma cells. [0012] The fusion protein, T cell vaccine, or the pharmaceutical composition includes the fusion protein for inhibiting or preventing cancer induced by human papillomavirus type 16 of the present invention comprise: an E7 peptide segment of human papillomavirus type 16; a translocating peptide segment possessing translocation function; and a peptide fragment having a carboxyl terminal section. [0013] The cancer induced by human papillomavirus type 16 can be inhibited or prevented by the fusion protein of the present invention or the pharmaceutical composition thereof. More precisely, the cancer is cervical cancer or lung cancer. In the fusion protein of the present invention, the nucleotide sequence of E7 peptide segment of human papillomavirus type 16 is preferred as SEQ. ID. NO.1. The peptide fragment can be selected from any known peptide fragment in the art, which has translocation function, and preferably is a part of pseudomonas exotoxin A. The peptide fragment of carboxyl terminal section can be selected from any known sequence of carboxyl terminal section in the art. Preferably, the peptide fragment of carboxyl terminal section is part of pseudomonas exotoxin, and, the peptide fragment of carboxyl terminal section comprises an amino acid sequence of KDEL, the peptide sequence is SEQ.ID.NO.2. [0014] The preferable amino acid sequence of fusion protein of the present invention is SEQ.ID.NO.3. [0015] The present invention also discloses an antibody composition, which is combined E7 peptide, wherein the nucleotide sequence corresponding to the E7 peptide is SEQ. ID. NO.1. The antibody composition of the present invention is able to detect the antigen of E7 peptide in vivo and then binds together in a way of “key and lock”. [0016] The fusion protein of the present invention can be applied for inhibiting or preventing the infection of human papillomavirus type 16. The pharmaceutical composition of the present invention can further include an adjuvant for enhancing the medical effect. The adjuvant can be any conventional adjuvant of the art. Preferably, the adjuvant is aluminum gel, oily adjuvant such as Freund's FCA, or FIA, mannide mono-oleate emulsifier, ISA 206, or ISA 720. More preferably, the adjuvant is ISA 206. [0017] The present invention is applied with the property of bacterial exotoxin in order to combine the bacterial exotoxin carried with protein and the surface acceptor of cell membrane of target cell (antigen presenting cell), the protein thus entering the cell and translocating the protein to cytoplasm by its natural ability of bacterial exotoxin; in the mean time, the external protein in cytoplasm can be prepared into small peptide and combined to MHC I or MHC II, and presented at the outside surface of the antigen presenting cell. The cell combined with MHC II or I will be identified by CD4 + cells or CD8 + cells, further induce a series of immune responses, and the immune ability of the fusion protein of the present invention is thus performed. [0018] The pharmaceutical composition of the present invention can selectively comprise any conventional adjuvant, dispersant, humectant (for example: Tween 80) and suspension to produce sterile injection, for example, a sterile injectable composition can be a solution or suspension in a non-toxic parenterally acceptable diluent or solvent, such as a solution in 1,3-butanediol. Among the acceptable vehicles and solvents that can be employed, mannitol or water is preferred. In addition, fixed oils are conventionally employed as a solvent or suspending medium (e.g., synthetic mono- or diglycerides). Fatty acid, (e.g. oleic acid or glyceride derivatives thereof), and pharmaceutically acceptable natural oils (e.g. olive oil or castor oil, especially polyoxyethylated derivatives thereof) can be used in the preparation of injected composition. These oil solutions or suspensions can also contain a long chain alcohol diluent or dispersant, carboxymethyl cellulose, or similar dispersing agents. Other commonly used surfactants such as Tweens, Spans, other similar emulsifying agents, or bioavailability enhancers which are commonly used in the manufacture of pharmaceutically acceptable solid, liquid, or other dosage forms can also be used for the purpose of formulation. [0019] A composition for oral administration can be any orally acceptable dosage form including capsules, tablets, emulsions and aqueous suspensions, dispersions, and solutions. In the case of tablets, the preferable vector is lactose, or corn starch. Lubricating agents, such as magnesium stearate, are also typically added. For oral administration in a capsule form, the used diluent is preferred to be lactose, or dried corn starch. When aqueous suspensions or emulsions are administered orally, the active ingredient can be suspended or dissolved in an oily phase combined with emulsifying or suspending agents. If necessary, certain sweetening, flavoring, or coloring agents can be added. vector. [0020] The vector in the pharmaceutical composition must be “acceptable” in the sense that it is compatible with the active ingredient of the composition (and preferably, capable of stabilizing the active ingredient) and not deleterious to the subject to be treated. Examples of other vectors include colloidal silicon oxide, magnesium stearate, cellulose, sodium lauryl sulfate, and D&C Yellow # 10. [0021] The fusion protein of the present invention or the pharmaceutical composition thereof can inhibit or prevent the disease induced by the infection of human papillomavirus type 16. Moreover, the concentration of the antibody induced by the fusion protein of the present invention or the pharmaceutical composition in a subject can last for a long time, and further enhance the medical effect. [0022] Other objects, advantages, and novel features of the invention will become more apparent from the following detailed description when taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0023] FIG. 1 shows the flow chart for a 8.0-kb plasmid (named pET-E7-KDEL3) encoding PE(ΔIII)-E7-KDELKDELKDEL (named PE(ΔIII)-E7-KDEL3) construction in example 2; [0024] FIG. 2 shows the result of in vivo tumor protection experiments in example 2; 100% of mice receiving PE(ΔIII)-E7-KDEL3 protein remained tumor-free 60 days after TC-1 challenge. In contrast, all of the unvaccinated mice and mice receiving E7, PE(ΔIII), and PE(ΔIII)-E7 protein groups developed tumors within 15 days after tumor challenge; [0025] FIG. 3 shows the numbers of E7-specific IFN-γ-secreting CD8 + T cell precursors in PE(ΔIII)-E7-KDEL3 group in example 6; [0026] FIG. 4 shows the results for evaluation of the PE(ΔIII)-E7-KDEL3 protein enhancing the titer of anti-E7 antibody in example 7; [0027] FIG. 5 shows the numbers of E7-specific CD 8 + T lymphocytes secreting from mice vaccinated with fusion proteins of the present invention with or without an adjuvant in example 8; [0028] FIG. 6 shows the anti-tumor effects in mice with or without an adjuvant in example 8; [0029] FIG. 7A shows the pulmonary tumor nodules in the in vivo tumor treatment experiments in example 9, wherein the symbols illustrate: (i) control group, (ii) E7, (iii) PE(ΔIII), (ix) PE(ΔIII)-E7, and (x) PE(ΔIII)-E7-KDEL3); [0030] FIG. 7B shows the anti tumor effects of mice vaccinated with various times of PE(ΔIII)-E7-KDEL3 protein in example 9; [0031] FIG. 8A shows the tumor prevention effects of mice vaccinated with various times of fusion protein in vivo in example 10; and [0032] FIG. 8B shows the tumor suppression effects of mice treated with various times of fusion protein in vivo in example 10. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT EXAMPLE 1 Synthesis of E7 Nucleotide and KDEL Sequence [0033] HPV type 16 E7 protein sequence (NC — 001526, SEQ.ID.NO.3) was found in the database of National Center for Biotechnology Information (NCBI), U.S.A., 98 amino acid were collected in total. [0034] The method disclosed in Taiwan patent application number 92126644 was conducted to express HPV16 E7 protein by E. coli system in large scale. Modification of the nucleotides in the present embodiment is to replace single base of wild type virus sequence with another base that expressed well in E. coli system, allowing target proteins expressed in E. coli the same as that expressed naturally. The modified sequence of HPV16 E7 nucleotide is SEQ.ID.NO.1. [0035] Eight pairs of primers were used for the synthesis of polynucleotides in the present example. The polynucleotide are synthesized by polymerase chain reaction (PCR). The sequence of all primers are shown in table 1. The sequences underlined represent as complementary fragments to a specific sequences. [0036] At first, F1 and R1 primers are used to perform polyneucleotides synthesis by PCR without DNA template. There are 15 bases designed for complementary to each other at 3′ end of the both primers, and a double strand DNA template was obtained thereby. After the first PCR, 1 μl of amplicon was used as DNA template to conduct the second PCR, and 4 μl of primers of F1, R2, required dNTPs, reagent and Pfu polymerase were mixed to perform the second PCR. The modified nucleotide sequence SEQ.ID.NO.1 was synthesized after eight times of PCR as described above. [0037] Signal peptides with KDEL sequence are prepared in the same method illustrated above. The primer sequence is shown as K3F AND K3R in table 1. The peptide sequence of the synthesized KDEL is SEQ.ID.NO.2. TABLE 1 Pri- Seq. Seq. mers ID. Sequence listing E7 F1 4 5′-AGAATTC ATG CAC GGT GAC ACC CCG ACC CTG CAC GAA TAC ATG CTG GAC CTC -3′ R1 5 5′- C GTA GCA GTA CAG GTC GGT GGT TTC CGG CTG GAG GTC CAG CAT GTA -3′ R2 6 5′- TTC GTC TTC TTC TTC GGA GGA GTC GTT CAG CTG TT C GTA GCA GTA CAG GTG -3′ R3 7 5′- GTC CGG TTC AGC CTG ACC AGC CGG ACC GTC GAT TTC GTC TTC TTC TTC -3′ R4 8 5′-T GCA GCA GAA GGT AAC GAT GTT GTA GTG AGC AGC GTC CGG TTC AGC CTG -3′ R5 9 5′-CTG AAC GCA CAG ACG CAG GGT GGA GTC GCA TT T GCA GCA GAA GGT AAC -3′ R6 10 5′- TTC CAG GGT ACG GAT GTC AAC GTG GGT GGA CTG AAC GCA CAG ACG -3′ R7 11 5′- AAC GAT ACC CAG GGT ACC CAT CAG CAG GTC TTC CAG GGT ACG GAT -3′ R8 12 5′- TTT GAA TTC CGG TTT CTG GGA GCA GAT CGG GCA AAC GAT ACC CAG GGT AC -3′ KDEL K3F 13 5′- AGAATTCGTGGAC TAC CTC AAA AAA GAC  GAA CTG AGA GAT GAA CTG -3′ K3R 14 5′-GTG GTG GTG CTC GAG TCA TTA CAG TTC GTC TTT CAG TTC ATC TCT CAG TT -3′ EXAMPLE 2 Vector Construction of Plasmids [0038] The E7 product obtained from PCR in example 1 is separated by 5% polyacrylamide agarose gel. The target product is purified according to the molecular weight of the product. VectorVectors pET or Ppe (ΔIII) are provided (J. R. Chen, C. W. Liao, S, J. T. Mao, and C. N. Weng, Vet. Microbiol. 80 (2001) 347-357) and digested with restriction endonuclease as well as vector the purified E7. Another electrophoresis is conducted with 5% polyacrylamide agarose gel for further isolating and purifying. Then 0.3 kb of E7 sequence fragment is obtained. 7.84 kb plasmid PE (ΔIII) is further constructed by ligasing the E7 fragment and the vectorvector, which comprises exotoxin A (ETA) but without enzyme toxic section. Moreover, a plasmid pPE (ΔIII)-E7 containing the fusion protein PE(ΔIII)-E7, and a 3.83 kb plasmid pE7 containing E7 fragment and pET23a are also constructed. [0039] A 3.78 kb pKDEL3 plasmid which encodes n′-KDELRDELKDEL polypeptide fragment is obtained by digesting, purifying the amplicon (obtained from PCR with K3-F, and K3-R primers), and further inserting into the site of Sall-Xhol of vector pET23a. [0040] A 8.0 kb plasmid pPE(DIII)-E7-K3 encoding fusion protein PE (ΔIII)-E7-K3 is obtained by digesting 1.47 kb KDEL sequence from pKDEL3 plasmid by restriction endonuclease Sall and Pstl, and further inserting into the spliced 6.5 kb, PE (ΔIII)-E7 plasmid DNA which is spliced by splicing by Xholl and Pstl. The flow chart of preparing plasmid mentioned above is as shown in FIG. 1 . [0041] The plasmid constructed above is further transformed to E. coli and maintained in the bacteria strain JM108. [0000] vectorvectorvector EXAMPLE 3 Purification of Protein [0042] The plasmid synthesized above is further transformed into E. coli BL21 (DE3) pLys strain. The transformed E. coli BL21 (DE3) pLys strain is cultured in the 200 ml LB culture medium containing 200 μg/ml ampicillin until the culture concentration reach 0.3 under OD550 spectrum. Then after 1 mM IPTG (isopropylthio-β-D-galactoside, Promege, USA) is added, the E. coli BL21 (DE3) pLys strain is cultured for 2 hours. The grown cells are collected by centrifugation. A freeze-thraw method is conducted to the target protein contained cells to loose the structure of cell membrane. 10 ml lysis buffer (0.3 mg/ml lysozyme, 1 mM PMSF and 0.06 mg/ml DNAse I) is added to the cultured cells, and then placed at room temperature for 20 minutes. 1 ml 10% Triton X-100 is added, and placed at room temperature for 10 minutes. The target proteins are released and collected by centrifugation at a rate of 1200×g for 10 minutes, resulting pallet was washed with 1M or 2M urea. At the end, the collected protein of inclusion body is dissolved in 8 ml 8M urea. [0043] The fusion proteins were then purified under the His-Tag system in the denatured condition as the manufacturer's manual (Novagen, USA). The denatured samples in 8M urea were loaded into a column packed with a NTA-Ni2 + -bind agarose resin. The bound proteins were then eluted with different pH buffer (from 8.0, 7.0, 6.5, 6.0, 5, 4, and 3.5) containing 6M urea, 0.3M NaCl, and 20 mM Tris-HCL and 20 mM phosphate buffer. After purified, protein elution fractions were analyzed for the purity and quantification by SDS-PAGE analysis as described previously. The purified protein product contained the amino acid sequence as shown in SQE:ID.NO.3. EXAMPLE 4 Preparing Carcinoma Cell Strain (TC-1) [0044] HPV16 E6, E7 and ras oncogene were used to transform primary lung epithelial cells of C57BL/6 mice. This tumorigenic cell line was named TC-1. TC-1 cells were grown in RPMI 1640, supplemented with 10% (vol/vol) fetal bovine serum, 50 units/ml penicillin/streptomycin, 2 mM L-glutamine, 1 mM sodium pyruvate, 2 mM nonessential amino acids and 0.4 mg/ml G418 at 37° C. with 5% CO 2 . On the day of tumor challenge, tumor cells were harvested by trypsinization, washed twice with 1× Hanks buffered salt solution (HBSS) and finally resuspended in 1× HBSS to the designated concentration for injection. EXAMPLE 5 In Vivo Tumor Protection Experiments [0045] The testing protein samples: E7, PE (ΔIII), PE (ΔIII)-E7, PE (ΔIII)-E7-KDEL3 are diluted with a phosphate buffer solution in a ratio of 1:10 to make the concentration at 0.1 mg/ml. Then the test samples are incubated at 37° C. for 2 hours. The incubated samples are mixed with 10% ISA206 (Sepec, France) by a vortex to form 4 kinds of different vaccines. Then 0.1 mg of each vaccine obtained is injected to the mice for vaccination. These mice were then boosted subcutaneously two weeks later with the same regimen as the first vaccination. One week after last vaccination, mice were challenged with 5×10 4 TC-1 tumor cells by subcutaneous injection in the right leg. Naive mice received the same amount of TC-1 cells to assess natural tumor growth control. Tumor growth was monitored by visual inspection and palpation twice weekly until 7, 14, 20, 30, and 60 days after after tumor challenge. The spleens of the sacrificed mice are also taken out for further checking. [0046] As shown in FIG. 2 , no cancer cells are found in the mice injected with PE (ΔIII)-E7-KDEL3. In other words, the percentage of the PE (ΔIII)-E7-KDEL3-injected mice without cancer cells is 100%. Moreover, even 60 days later, none of the PE (ΔIII)-E7-KDEL3-injected mice has cancer. In contrary, cancer cells can be found in the mice injected with E7, PE (ΔIII), or PE (ΔIII)-E7, or the mice of control. The longest period without cancer cells among these mice is 20 days. According to the result of the experiment, only fusion protein include the sequence of PE (ΔIII), and KDEL3, and the fragment of E7 can prevent and inhibit the growth of cancer cells in the cancer-inducing model illustrated above. EXAMPLE 6 Cell Immune Experiment [0047] Mice are injected, and cancer-induced as described in example 5. One week later, the mice are sacrificed and the spleen macrophages are taken out. Before intracellular cytokine staining, 3.5×10 5 pooled splenocytes from each vaccinated group were incubated for 16 hours with either 1 μg/ml of E7 peptide (aa 49-57) containing an MHC class I epitope for detecting E7-specific CD8 + T cell precursors. Cell surface marker staining of CD8 + or CD4 + and intracellular cytokine staining for IFN-γ, as well as FACScan analysis, were performed using conditions described by Cheng, et al. (Hum Gene Ther, 13:553-568, 2002) to compare the E7-sepcific immunological assays in mice received different regimens of vaccination. [0048] In the present example, it is confirmed that PE (ΔIII)-E7-KDEL3 has influence for E7 specific immunization, as shown in FIG. 3 . In the mice of the group injected with PE (ΔIII)-E7-KDEL3, it is founded that the numbers of E7-specific IFN-γ-secreting CD8 + T cell precursors in PE(ΔIII)-E7-KDEL3 group were higher than those in the other groups (10.0±11.4 in nave group, 14.0±2.1 in E7 group, 12.0±2.1 in PE(ΔIII) group, 36.0±2.8 in PE(ΔIII)-E7 group, 564.0±28.0 in PE(ΔIII)-E7-KDEL3, p<0.01, AVONA). [0049] According to the result above, the number of E7-specific IFN-γ(+) CD8(+) T cell precursors of the mice vaccinated with PE(ΔIII)-E7-KDEL3 protein is 40 times higher than that vaccinated with E7. EXAMPLE 7 E7 Specific Antibody Evaluation [0050] Mice are vaccinated with 0.1 mg of the E7, PE (ΔIII), PE (ΔIII)-E7, PE (ΔIII)-E7-KDEL3 fusion proteins as described in example 5. Further boosts after one and two weeks later with the same regimen as the first vaccination are conducted. The mouse serum is collected at the 7 th day after the last immunization. [0051] Briefly, a 96-microwell plate was coated with 100 μl of bacteria-derived HPV-16 E7 proteins (0.5 μg/ml) and incubated at 4° C. overnight. The wells were then blocked with phosphate-buffered saline (PBS) containing 20% feta bovine serum. Sera were prepared from mice of various vaccinated groupd serially diluted in PBS, added to the ELISA wells, and incubated at 37° C. for 2 hr. After washing with PBS containing 0.05% Tween 20, the plate was incubated with a 1:2000 dilution of a peroxidase-conjugated rabbit anti-mouse IgG antibody (Zymed, San Francisco, Calif.) at room temperature for 1 hr. The plate was washed, developed with 1-Step Turbo TMB-ELISA (Pierce, Rockford, Ill.), and stopped with 1 M H 2 SO4. The ELISA plate was read with a standard ELISA reader at 450 nm. [0052] C57BL/6 mice were immunized subcutaneously with PE(ΔIII)-E7-KDEL3 mixed 10% ISA206 adjuvant one to three times. Sera were prepared and the E7-specific antibody titers were detected by the ELISA as described earlier. [0053] In the present example, it is further confirmed that PE (ΔIII)-E7-KDEL3 is able to improve the potency of resisting E7 antibody. As shown in FIG. 4 , mice vaccinated with the PE(ΔIII)-KDEL/E7 protein generate highest titers of anti-E7 Ab's in the sera of mice compared with those vaccinated with other fusion protein (for 1:100 dilution, 0.629±0.093 in naïve group, 0.882±0.086 in E7 group, 0.690±0.06 in PE(ΔIII) group, 0.930±2.80.06 in PE(ΔIII)-E7 group, 3.593±0.54 in PE(ΔIII)-E7-KDEL3, p<0.01, AVONA). Apparently, PE(ΔIII)-E7-KDEL3 protein could also enhance the titer of anti-E7 antibody. [0054] The data showed that PE(ΔIII)-E7-KDEL3 fusion protein could enhance E7-specific immunological responses (including the numbers of E7-specific CD4 + and CD8 + T lymphocytes and the titers of E7-specific antibodies). [0055] All the obtained readings are expressed with Mean Value and Mean±SEM. The compared data from the experiment will be processed ANOVA analysis by Statistical Package for Social Sciences, SPSS 9.0, SPSS Inc, Chicago, Ill.; there is a significant difference of the data if the statistical error is under 0.05. EXAMPLE 8 Application of an Adjuvant in a Vaccine Composition [0056] In many cases, peptides or proteins are poorly immunogenic and hardly induce a response when they injected alone. Hence, an adjuvant is usually injected together with peptides or proteins. Examples of such adjuvants include BCG, incomplete Freund's adjuvant, cwellra toxin B, GM-CSF, ISA206 and IL-12, wherein ISA206 is used for the protein adjuvant of the present embodiment. [0057] The fusion proteins here are PE (ΔIII)-E7, and PE (ΔIII)-E7-KDEL3. The process of mice vaccination was the same as that described above in examples 5 and 6. Samples of fusion proteins were mixed with or without 10% ISA206 adjuvant (SEPPIC, France). The result is shown in FIG. 5 , wherein the first sample group (i.e. the blank sample group) showed no significant immune response for E7 specific CD 8 + T lymphocytes stimulation. The same result can be found in the second sample group. In other words, no matter E7 is included in the vaccine or not, there is no significant numbers of antibody induced by the vaccine composition without adjuvants. However, the numbers of E7 specific CD 8 + T lymphocytes is about 600, which is 500-600 times higher than that induced by the vaccine composition without adjuvant. [0058] As shown in FIG. 6 , the period for preventing the proliferation of cancer in the induced mice by administrating (through injection) the mice with the vaccine composition having PE (ΔIII)-E7-KDEL3 and adjuvant is 60 days. In contrary, for the mice administrated with the vaccine composition of PE (ΔIII)-E7-KDEL3 without an adjuvant, the population of the mice with tumor is almost the same as that of the control group which is not vaccinated with fusion proteins of the present invention. Mice immunized with PE(ΔIII)-E7-KDEL3 protein alone (i.e. without an adjuvant) could not generate potent E7-specific immunological responses and anti-tumor effects (data not shown). However, according to the result, vaccine compositions of PE(ΔIII)-E7-KDEL3 protein of the present invention comprising an adjuvant is preferred for application for capability to induce optimal immunological responses. EXAMPLE 9 [0059] In vivo tumor treatment experiments were performed using a lung hematogenous spread model. C57BL/6 mice mice (five per group) were challenged with 5×10 4 cells/mouse TC-1 tumor cells via tail vein. Two days after tumor challenge, mice received 0.1 mg/mouse of E7, PE(ΔIII), PE(ΔIII)-E7 or PE(ΔIII)-E7-KDEL3 protein vaccines subcutaneously, followed by a booster with the same regimen every 7 days for 2 weeks (a total of four times, 0.3 mg protein). Mice receiving no vaccination were used as a negative control. Mice were sacrificed and lungs were explanted on day 30. The pulmonary tumor nodules in each mouse were evaluated and counted by experimenters blinded to sample identity. [0060] The representative figures of pulmonary tumor nodules in various protein-vaccinated groups are shown in FIGS. 7A and 7B . As shown in FIG. 7A , only the mice accepting the PE(ΔIII)-E7-KDEL3 fusion protein don't have lung cancer. The mean lung weight (214.4±11.6) of the mice treated with PE(ΔIII)-E7-KDEL3 showed significantly lower than those of mice treated with PE(ΔIII)-E7 (673.6±20.8) or wild-type E7 protein (811.1±45.6) (one-way ANOVA, p<0.001) These data indicated that mice treated with PE(ΔIII)-E7-KDEL3 could control established E7-expressing tumors in the lungs. EXAMPLE 10 [0061] Evaluation of the E7-specific immunological profiles of the mice immunized with different times of PE(ΔIII)-E7-KDEL3 protein vaccine could reflect the anti tumor effects of the mice. As described earlier in examples 5 and 6, mice were challenged with TC-1 tumor cells and then received 0.1 mg PE(ΔIII)-E7-KDEL3 protein from one to three times as described earlier. Mice were sacrificed on day 30 and the pulmonary tumor nodules in each mouse were evaluated and counted as described earlier. [0062] As shown in FIG. 8A , all of the naïve mice and mice immunized one time of PE(ΔIII)-KDEL3 protein vaccine grew tumors within 14 days after tumor cell TC-1 challenged. And 60% or 100% of mice immunized with 2 or 3 times of PE(ΔIII)-KDEL3 protein vaccine were tumor-free 60 days after tumor challenge, respectively. [0063] Similar phenomena were also observed in the tumor treatment experiments as described in example 9. The pulmonary tumor nodules decreased significantly from one to three shots of PE(ΔIII)-KDEL3 protein vaccine (103.0±3.8 for one time, 28.8±6.1 for two times, 0.6±0.4 for three times, p<0.001, ANOVA) [0064] Our results show that increasing shots of PE(ΔIII)-KDEL3 protein vaccine could improve the preventive and therapeutic anti-tumor effects of E7-expressing tumor cells. [0065] PE(ΔIII)-E7-KDEL protein could enhance MHC class I presentation of E7 in cells expressing this fusion protein to enhance E7-specific CD8+ T-cell activity in vivo. [0066] According to the examples illustrated above, the fusion protein of the present invention can enhance the stimulation of the precursor of E7 specific CD 8 + T lymphocytes and CD 4 + T lymphocytes by enhancing the presentation of the E7 antigen through MHC I and II. The concentration of the E7 specific antibody can be increased through the mechanism illustrated above. Moreover, the cancer induced by E7 can be inhibited or prevented through the administration of the fusion protein of the present invention. In addition, the mice vaccinated by the fusion protein of the present invention have longer time for inhibiting cancer. [0067] Although the present invention has been explained in relation to its preferred embodiment, it is to be understood that many other possible modifications and variations can be made without departing from the spirit and scope of the invention as hereinafter claimed.

1a

BACKGROUND OF THE INVENTION This invention generally relates to dispensers of vaporizable media. More specifically, this invention relates to a device for dispensing a fragrance or deodorant in the form of a vapor for air freshening in an enclosed environment. The need for effectively combating airborne malodors in homes and enclosed public buildings, by odor masking or destruction, is well established. Various kinds of vapor-dispensing devices have been employed for this purpose. The most common of such devices is the aerosol container which propels minute droplets of an air freshener composition into the air. Another common type of dispensing device is a dish containing or supporting a body of gelatinous matter which when it dries and shrinks releases a vaporized air-treating composition into the atmosphere. Other products such as deodorant blocks and liquid wicks are also used for dispensing air-treating vapors into the atmosphere by evaporation. Another group of vapor-dispensing devices utilizes a carrier material such as paperboard impregnated or coated with a vaporizable composition. A number of recent developments include a liquid air-treating composition in an enclosure, all or part of which is formed of a polymeric film through which the air-treating composition can migrate to be released as a vapor at an outer surface. Use of this type of permeable polymeric membrane controls the dispensing of air-treating vapors and tends to eliminate great variations in the rate of dispensing over the life of the product. Such products are considered advantageous when compared with the many air-treating products for which the rate of vapor release drops substantially over the life of the product. Products of the type having a sheet of permeable polymeric material to control the emission of air-treating vapors may be in a variety of forms. In some, the polymeric sheet covers a cylindrical container, while in others the liquid air-treating material is trapped between the permeable sheet and an impermeable plastic sheet. In still others, the permeable polymeric material forms a flexible pouch having a content of the air-treating liquid. The liquid, prior to activation, is isolated within a breakable container such as a glass vial or an impermeable plastic inner pouch, or the like. Publications of background interest in connection with air freshener devices include U.S. Pat. Nos. 2,481,296; 2,594,714; 3,790,081; 3,946,945; 4,130,245; 4,145,001; 4,220,281; 4,306,679; 4,382,548; 4,502,630; 4,558,820; 4,583,686; 4,595,925; 4,615,486; 4,660,763; 4,630,775; 4,739,928; 4,849,606; 4,948,047; 4,960,240; 4,983,578; 4,998,671; and the like; incorporated by reference. U.S. Pat. No. 4,157,787 describes an air freshener device which consists of a container with an open topside. The open topside is bordered by a peripheral flange, and the container has a content of a volatile ingredient. The topside of the container is sealed with two coextensive layers of thin plastic film bonded to the peripheral flange surface. The inner layer is a vapor-permeable film, and the outer layer is a peelable vapor-impermeable film. Some air freshener dispensers are expensive to manufacture. Other air freshener dispensers are inexpensive to produce, but tend to have inferior construction and functionality. There remains a need for a well-constructed air freshener dispenser device which can be mass-produced economically and which can deliver a vapor medium at a controlled uniform rate over an extended period of time. Accordingly, it is an object of this invention to provide an improved air freshener dispenser device for delivering an odorant and/or deodorant vapor in an enclosed environment. It is another object of this invention to provide an air freshener dispenser device with a primary structure which is a semi-rigid plastic assembly that can be produced economically by a thermoforming means. It is another object of this invention to provide an air freshener dispenser device that consists of multiple cartridges which provide a more versatile range of air freshener dispensing functionality. It is another object of this invention to provide an air freshener dispenser device which has a pair of cartridge units which are connected end-to-end by a flexible hinge means. It is a further object of this invention to provide an air freshener dispenser device with dual rigidly supported reservoir enclosures which respectively have a volatile air freshener content, and which respectively have a topside sealed with a translucent or transparent permeable membrane. Other objects and advantages of the present invention shall become apparent from the accompanying description and drawings. SUMMARY OF THE INVENTION One or more objects of the present invention are accomplished by the provision of an air freshener dispenser device consisting of an attached pair of identical cartridge units which are connected end-to-end by a flexible hinge means, wherein each cartridge is a structural assembly comprising: (a) an elongated shallow tray having side walls with an upper edge flange which forms a peripheral margin around the open space of the tray; (b) a thin membrane which covers the open space of the tray and is bonded to the flange peripheral margin, and the membrane forms a sealed reservoir enclosure within the tray interior, and the said membrane is permeable to a volatile medium in the reservoir enclosure; (c) a volatile air freshener medium which is contained within the reservoir enclosure; and (d) a thin peelable impermeable membrane which is laminated coextensively with the permeable membrane to prevent volatilization of the air freshener medium through the permeable membrane from the reservoir enclosure. DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of an invention air freshener dispenser device with an imprinted design. FIG. 2 is a cross-sectional view taken along lines 2--2 of FIG. 1. FIGS. 3-5, respectively, illustrate alternative reservoir configurations for the tray interior and volume of air freshener ingredient taken along lines 2--2 of FIG. 1. FIG. 6 is a side view of a FIG. 1 air freshener dispenser device which is folded in a tray-bottom to tray-bottom configuration of the twin cartridges. DESCRIPTION OF THE PREFERRED EMBODIMENTS FIG. 1 illustrates a present invention air freshener dispenser device 10 which has a design imprinted on the upper surface of each cartridge. A FIG. 1 type of air freshener dispenser device has a semi-rigid structure, and its typical dimensions are about nine inches in length, about one half to one inch in width, and about one sixteenth to one half inch in thickness. A FIG. 1 type of air freshener dispenser device can be utilized by peeling the outer impermeable membrane partially or completely from one cartridge, or peeling the outer impermeable membrane from each of the twin cartridges. FIG. 2 is a cross-sectional end view of a FIG. 1 type of air freshener dispenser cartridge which has tray 12 and air freshener ingredient 14, and a flange 15 which is seal-bonded with inner thin film vapor-permeable membrane 16 and coextensive outer thin film vapor-impermeable membrane 18. FIG. 3 is a cross-sectional end view similar to FIG. 2, in which centrally disposed structural reinforcing rib 19 extends along the bottom surface of tray 12. FIG. 4 is a cross-sectional end view similar to FIG. 3, in which two spaced structural reinforcing ribs 19 extend along the bottom surface of tray 12. Rib 19 can have a configuration which is adapted to key tray 12 into a conformational slotted space in a dispensing housing structure. FIG. 5 is a cross-sectional end view of an alternative reservoir configuration with a stepped structure. FIG. 6 is a side view of a FIG. 1 air freshener device, which has cartridges 20 folded 90° C. with trays 12 in a bottom-to-bottom configuration. Cartridges 20 are folded along seams 21. FIG. 6 also illustrates the partial removal of membrane 18 from the surface of membrane 16 of the upper positioned cartridge 20. Tray 12 of each cartridge 20 can be constructed by either injection or thermoform molding of a thermoplastic polymer such as polyethylene, polypropylene, polyvinyl chloride, and the like. In a preferred embodiment, end-to-end attached trays 12, and interconnecting flexible hinge band 23, are thermoformed as a unitary structure, and optionally include folding seams 21 to facilitate a 90° C. folding of cartridges 20. Thin film vapor-impermeable membrane 18 is bonded to thin film vapor-permeable membrane 16 in the form of a laminate. Vapor-impermeable membrane 18 is peelable, so that its removal allows air freshener ingredient 14 to migrate through vapor-permeable membrane 16 and volatilize into the atmosphere. Peelable membrane 18 can be adapted for removal from both cartridge units at the same time, or from each cartridge unit at different times. Vapor-permeable membrane 16 can be in the form of a flexible thin film of a thermoplastic polymer such as polyethylene, isotactic polypropylene, cellulose acetate, and the like. Membrane 16 permits migration of the enclosed volatile air freshener ingredient 14, either as a liquid or a vapor, depending on the type of membrane 16 being employed. Membrane 16 can be a microporous type (submicron pores), such as isotactic hydrophobic polypropylene film sold under the CELGARD tradename (Celanese). Microporous thermoplastic polymer films are described in U.S. Pat. No. 3,055,297; incorporated by reference. Vapor-impermeable membrane 18 can be in the form of a flexible thin film such as aluminum foil or nylon film, which is peelable from its adhering bond to vapor-permeable membrane 16. In a preferred embodiment a laminate of membrane 16 and membrane 18 is preformed, and then applied to tray 12 to cover the open interior, and heat-sealed along periphery flange 15 to enclose the reservoir content of air freshener ingredient 14. Production of a laminate of permeable and impermeable membranes is illustrated in U.S. Pat. No. 4,145,001; incorporated by reference. In another preferred embodiment the membrane laminate is not heat-sealed to periphery flange 15 at the respective ends of twin cartridges 20. In FIG. 1 the heat-sealing of the membrane laminate end sections is shown as chevron-shaped heat-seal 22. This facilitates manual gripping and peeling of membrane 18 from membrane 16. Air freshener ingredient 14 can be any air treating material which can migrate through membrane 16 and disperse into the atmosphere in vapor form. Typically air freshener ingredient 14 is a fragrance or a deodorant in liquid or gel form. Preferably, air freshener ingredient 14 is a liquid fragrance comprising one or more volatile organic compounds which are available from perfumery suppliers such as Firmenich Inc., Takasago Inc., Noville Inc., Quest Co., and Givaudan-Roure Corp. Most conventional fragrance materials are volatile essential oils. The fragrance can be a synthetically formed material, or a naturally derived oil such as oil of Bergamot, Bitter Orange, Lemon, Mandarin, Caraway, Cedar Leaf, Clove Leaf, Cedar Wood, Geranium, Lavender, Orange, Origanum, Petitgrain, White Cedar, Patchouli, Lavandin, Neroli, Rose absolute, and the like. A wide variety of chemicals are known for perfumery, such as aldehydes, ketones, esters, alcohols, terpenes, and the like. A fragrance can be relatively simple in composition, or can be a complex mixture of natural and synthetic chemical components. A typical scented oil can comprise woody/earthy bases containing exotic constituents such as sandalwood oil, civet, patchouli oil, and the like. A scented oil can have a light floral fragrance, such as rose extract or violet extract. Scented oil also can be formulated to provide desirable fruity odors, such as lime, lemon or orange. Synthetic types of fragrance compositions either alone or in combination with natural oils are described in U.S. Pat. Nos. 4,314,915; 4,411,829; and 4,434,306; incorporated herein by reference. Other artificial liquid fragrances include geraniol, geranyl acetate, eugenol, isoeugenol, linalool, linalyl acetate, phenethyl alcohol, methyl ethyl ketone, methylionone, isobomyl acetate, and the like. A liquid fragrance also can be formed into a thixotropic gel by the addition of a thickening agent, such as fumed silica of the type marketed under the Cabosil trademark (Cabot Corporation). A fragrance ingredient also can be in the form of a crystalline solid, which have the ability to sublime into the vapor phase at ambient temperatures. A crystalline fragrance starting material can be selected from organic compounds which include vanillin, ethyl vanillin, coumarin, tonalid, calone, heliotropene, musk xylol, cedrol, musk ketone benzophenone, raspberry ketone, methyl naphthyl ketone beta, phenyl ethyl salicylate, veltol, maltol, maple lactone, proeugenol acetate, evemyl, and the like. This type of fragrance can contribute a long term air-treating capability to an air freshener dispenser device. A present invention air freshener dispenser device can be produced in a continuous process by providing a moving band of thermoformed end-to-end hinged trays in repeating unitary sections, in combination with an air freshener filling station, and a moving band of flexible membrane laminate in contacting and sealing proximity with the flanges of the filled trays. The unitary sections are cut and trimmed from the moving band at the terminal end of the production line. A present invention air freshener device can be produced in high volume from relatively inexpensive plastic materials. After usage, the device qualifies for disposal as a non-hazardous solid waste. The present invention also contemplates an integrated combination of a FIG. 1 type air freshener device and a dispensing holder structure. The FIG. 1 device then functions as a replaceable assembly having a dual refill cartridge capacity.

1a

This is a Divisional of Application Ser. No. 936,876 filed Aug. 25, 1978, now U.S. Pat. No. 4,201,770, which in turn is a continuation-in-part of Ser. No. 622,031 filed Oct. 14, 1975, now abandoned, which in turn is a continuation-in-part of application Ser. No. 462,955 filed Apr. 22, 1974, now abandoned, which in turn is a continuation-in-part of application Ser. No. 406,821 filed Oct. 16, 1973, now abandoned, which in turn is a continuation-in-part of application Ser. No. 357,892, filed May 7, 1973, now abandoned. BACKGROUND OF THE INVENTION It is well known that antibodies are generated in humans and in other animals in response to the presence of foreign antigers. It is also known to confer immunity on an animal by administering an antibody formed elsewhere. For instance, the patents to Michaelson (U.S. Pat. No. 3,553,317), Friedheim (U.S. Pat. No. 2,388,260), Reusser (U.S. Pat. No. 3,317,400) and Peterson (U.S. Pat. No. 3,376,198) relate to production of antibodies, which when injected into an animal of a different species or into a human being cause passive immunization. In patents to Fell (U.S. Pat. Nos. 2,301,532 and 2,372,066), the patentee refers to active immunization using modified histamine in such animals as horses, cows, etc. In a paper by R. G. Edwards in the British Medical Journal, Vol. 26, pages 72 to 78, published in 1970 on "Immunology of Conception and Pregnancy", he surveys the literature regarding the possibilities of utilizing immunological methods to influence or control fertility, surveying first production of antibodies against testes or spermatozoa. Much of the literature surveyed is directed to the production of foreign antibodies which are injected into the subject (passive immunization). Hormone antibodies have been studied for a long time and the effect of specific antisera have been recorded for many years. It is known that administration of certain antibodies during pregnancy can suppress implantation or cause fetal resorption. Several different approaches have been tried ranging from the induction of near permanent infertility in the case of agglutination of spermatozoa in the male to the disturbance of a single pregnancy by passive immunization with antibodies. There are serious limitations to the use of passive immunization procedures for human therapy. Since the antibodies are practically produced only in non-human animals, the repeated injection of animal proteins into humans is known to produce serious reaction in many individuals. British patent No. 1,058,828 discloses that small molecules, referred to as "serological determinant peptides," can be coupled to large protein molecules, such as cattle albumin and the resultant conjugate then may be injected into animals for antibody production. The document lists proteins from which the serologically determinant peptides may be isolated prior to being used in the process taught, the collection including viruses and bacteria whose surface component has the characteristics of a protein, toxins ad hormones having protein structure and enzymes. No specific hormone is named in the document and no utility of anti-hormone immunization is described. The patent specification references a publication entitled: "The Specificity of Serological Reactions", Dover Publications, Inc., New York, 1962, Chapter V, "Artificial Conjugated Antigens" by K. Landsteiner. This publication outlines various chemical methods and applies them passively to bind various toxic substances in the blood such as arsenic. Thyroxine data provided in the publication suggests that such methods may be applied to protein hormones without indicating the therapeutic application, the publication teaching that specific antibodies may be formed to the small molecules and these antibodies are capable of neutralizing the biological action of a large protein from which the small peptide was a part. Recently it has been discovered that doses of certain steroids consisting of synthetic non-protein hormones ("The Pill") when administered at stated intervals usually confer protection against pregnancy for a short time (possibly a month). This medication has sometimes been found to create undesirable side effcts in creating undesirable metabolic changes and sometimes changes in the blood clotting mechanisms. Moreover, the effect of each dose is of such short duration that often it is of limited application, particularly in remote areas to persons not readily instructed on proper and continuing use. There is need therefore of an effective safe method of creating a temporary but relatively long-time immunity against pregnancy which does not have serious side effects. There is also a need for an effective safe method of terminating a pregnancy soon after conception which does not have serious harmful side effects. Such need may be met by the neutralization of a reproductive protein which is necessary for the normal events of conception and/or gestation. There is also a need for a means for control of various disease states or maladies caused or influenced by unusual excesses of certain polypeptides such as gastrin, angiotension II, or somatomedian. It is believed that this invention meets this need safely and effectively. SUMMARY OF THE INVENTION This invention is concerned (1) with the production of antigens for the purpose of active immunization, (2) with the antigens so produced, and (3) with the use of said antigens. More particularly, the invention relates to antigens consisting of natural protein reproductive hormones, non-hormonal proteins, specific fragments of such hormones and proteins and synthetically derived portions of said hormones and proteins, all modified as will be indicated more fully hereinafter. For the sake of simplicity, hereinafter in this specification and in the claims, these antigens are collectively referred to as modified polypeptides. The invention is directed in one aspect to the use of modified polypeptides in actively immunizing an animal, particularly mammals, against the biological action of endogenous unmodified non-hormonal natural protein and/or hormone. The state of immunity arises because of the creation of antibodies which act against both the antigenic modified polypeptide and its endogenous counterpart which is neutralized (rendered biologically ineffectual) as a result of the existence of said antibodies. The immunity may take place because of the inability of the antibody to distinguish between the modified polypeptide and the naturally existing protein, but it is uncertain that this is in fact the situation. In effect, the invention provides, in one aspect, for the isoimmunization of a primate animal. A more specific aspect of this invention relates to the modification of protein reproductive hormones by adding certain numbers of foreign moieties to each hormone molecule, or hormonal fragment. The modification must be sufficient to cause the body to create antibodies to the modified hormones which will neutralize or inhibit the biological action of the natural hormones produced by the body. Thus, the modified hormones become antigenic and cause the production of antibodies which disrupt the natural processes of conception and/or gestation. The term "protein reproductive hormones" includes those hormones essential to the normal events of the reproductive process. According to a further aspect of this invention, a disease state which can be treated by application of the technique of the instant invention is the digestive disorder known to those skilled in the medical field as the Zollinger-Ellison Syndrome. This syndrome or disease state is generally described as a condition in which a hyper secretion of the polypeptide gastrin, which is produced in the pancreas and brings about a state of hyperacidity in the stomach which results in a chronic digestive disorder. Heretofore, the only effective treatment for this disease state was the surgical removal of a part or total removal of the subject's stomach. Although survival of such patients is usually not threatened, the medical state and life style of such individuals is severely affected by such treatment. Treatment of such subjects with hapten coupled (produced according to the general method described herein) or otherwise chemically modified gastrin can be used to enhance the production of antibodies against the hypersecretion of gastrin and thereby alleviate or reduce the symptoms of this disease without surgical intervention. Sufficient reduction by immunological means of this substance in the system of the body would be sufficient to avoid the complicated and serious consequences of the surgical treatment currently in use. In practice, an effective amount of modified gastrin is simply injected into the patient as required to accomplish the control of the flow or presence of gastrin. Another serious medical problem which is treatable by the application of the technique of the instant invention is that of hypertension. In general terms, the state of hypertension is the abnormal level or fluctuation of one's blood pressure. The blood pressure in an individual is controlled by many physiological processes in the body. However, one major substance effecting the regulation of such pressure is the hormonal polypeptide known as angiotension II. In certain states of high blood pressure (hypertension) it is difficult to medically control the secretion and therefore the level of angiotension II in the circulatory system. By the appropriate modification of this hormone and subsequent immunization with this altered modified proteinaceous hormone, it is possible to reduce the secretion of angiotension II in patients with chronically elevated hormone levels. The predictable and controlled reduction of this substance is beneficial to certain patients with chronic problems of hypertension. Modified angiotension II can be produced by the general protein modification technique described herein. The resultant modified angiotension II is simply injected into the patient in an amount sufficient to induce antibody response sufficient to control or regulate unmodified angiotension II to the desired degree. A further embodiment of the present invention is the treatment of diabetes and associated micro and macro vascular diseases. Currently, the treatment of diabetes is limited to dietary and/or drug treatment to regulate blood glucose levels. Recent scientific data support the concept that growth hormone and somatomedian (both polypeptides) are intimately involved in the disease syndrome. These substances can be modified by the technique described herein and used in an effective amount to control the progress of this disease. In practice, modified growth hormone or modified somatomedian is injected into the body to develop antibodies for control of the normally secreted hormones. Another health problem that can be treated by the use of the concepts of this invention is that of certain endocrine or hormone dependent breast tumors or cancers. Certain of these cancers have been shown to be dependent upon the abundant secretion of the hormone prolactin for their continued survival. The inhibition of the secretion of prolactin has been shown to diminish the growth rate and the actual survival of certain of these tumors. The immunization of such subjects with the hapten coupled or otherwise altered prolactin produced as described herein, would result in the systematic reduction of the level of this hormone circulating in the system and consequently, may result in the regression or remission of tumor growth. The consequence of this treatment would be far more favorable in terms of effective treatment of this disease since surgical removal of the breasts is a principal method of treatment currently available. It should be understood that this treatment should be effective for only those tumors that are dependent upon the secretion of prolactin for survival. Investigators also have determined, for example, that certain polypeptide entities are supportive factors to and secretions of neoplastic diseases in both man and other animals. These entities have biochemically, biologically and immunologically close resemblances to hormones, particularly to Chorionic Gonadotropin (CG), as well as to Luteinizing Hormone (LH). By applying the isoimmunization techniques of the invention, the function of such polypeptides or endogenous counterparts can be neutralized to carry out regulation of the malignancy. For example, tumors in both male and female primates may be treated by isoimmunization procedures developing antibodies to Chorionic Gonadotropin or Luteinizing Hormone or the noted entity analogous thereto. Further, neoplasms in primate females may be regulated by isoimmunization procedures developing antibodies to endogenous Follicle Stimulating Hormone (FSH). This hormone, when associated with a tumor state, tends to aggravate the tumorous condition. The immunochemical control asserted, as noted, neutralizes the naturally occuring hormone or the above-described entity biologically analogous thereto. As a consequence, the hormone or entity will not be available as would normally be the case, for example, the stimulation of some action of a target tissue. Conversely, the neutralization of the biological activity of the hormone or analogous entity may serve to take away an inhibitory action which it otherwise might assert. There are certain other disease states that may be treatable by the use of altered or modified hormonal or non-hormonal proteins as antigens. The disease states and the associated substances that may be used as modified antigens for immunological treatment of these diseases will be listed as follows: (1) modified parathyroid hormone for the treatment of kidney stones, (2) modified insulin and/or glucagon for the treatment of hyperinsulinoma, (3) modified thyroid stimulating hormone (TSH) for the treatment of hyperthyroidism, and (4) modified secretin for the treatment of irritable bowel syndrome. Another group of polypeptides which can be altered by the procedures described herein and used in the field of human fertility control are specific non-hormonal protein antigens isolated from placental tissue. There is direct evidence that inhibition of substances that are specific to the placental tissue and do not have similar antigenic properties with other antigens from organs in other parts of the body, can result in the disruption of pregnancies by passive immunization. Such specific placental substances when modified to form modified polypeptides by the procedures described herein can be injected into the body of an animal of the same species as an effective fertility control means with the mechanism being active immunization similar to that described for the antigenic modification of hormones. The particular advantages of these substances in that placental antigens are foreign to the non-pregnant female human subject and therefore are unlikely to cause any cross-reaction or disruption of normal body function in the non-pregnant female. While the invention is useful for the human species it will be appreciated that it is also useful in connection with other animals. Similarly, while the reference herein with respect to fertility control is primarily directed to females, such described techniques may be applicable to males, i.e. FSH, its beta subunit and fragments thereof. Such immunization represents an effective fertility control procedure, providing no physiological consequences are encountered which may be found to react adversely to the performance of other body constituents. Whether the concerned hormone, non-hormonal protein or specific fragment thereof which is modified is naturally occurring or is a synthetic product is clearly immaterial. A synthetic protein molecule will perform the same function as the naturally occurring one, inasmuch as the body will react in an equivalent antigenic manner. It has accordingly been discovered by virtue of this invention that it is possible to interfere with or treat various disease states or medical problems which are caused or influenced by certain polypeptides by active immunization of a male or female animal by the production and use of antigens formed by administration of modified polypeptides. The modification of the polypeptides forms antigens which are then administered into an animal in which immunization is to be developed. Said modification is accomplished by attaching to a polypeptide one or more foreign reactive (modifying) groups and/or by attaching two or more polypeptides to a foreign reactive group (i.e., a carrier) or both of the above, so that the body of the animal, recognizing the modified polypeptide as a foreign object, produces antibodies which neutralize not only the modified protein but also the natural protein which is responsible for the disease or medical problem being regulated. In order to produce an effective quanta of antibodies to the antigen or targeted functional polypeptide, it may be advantageous to administer the modified polypeptide together with an immunological adjuvant. The term "adjuvant" is commonly referred to by those engaged in the field at hand as being a substance which will elevate the total immune response of an animal or person to any immunization thereof, i.e. the adjuvant is a nonspecific immuno-stimulator. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a chart describing the results of mating four baboons three times following the administration thereto of a fertility controlling antigen according to the invention; FIG. 2 shows two plots illustrating the antifertility antibody levels maintained within two baboons following the administration of antigens thereto formulated in accordance with the invention; and FIG. 3 shows three dose response lines illustrating the specificity of antibody response to a CG antigen formulated in accordance with the invention. GENERAL DESCRIPTION In an effort to better define the modified polypeptides with which this invention is concerned, it is first considered appropriate to set out more precisely than hereinabove, examples of the natural hormones and natural non-hormonal proteins modified according to this invention. They include Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH), Chorionic Gonadotropin (CG), e.g. Human Chorionic Gonadotropin (HCG), Placental Lactogen, e.g. Human Placental Lactogen (HPL) Prolactin, e.g. Human Prolactin (all of which are proteinaceous reproductive hormones), gastrin, angiotension II, growth hormone, somatomedian, parathyroid hormone, insulin, glucagon, thyroid stimulating hormone (TSH), secretin, and other polypeptides which could adversely affect body function. The hormone Chorionic Gonadotropin (CG) has been the subject of extensive investigation, it being demonstrated in 1927 that the blood and urine of pregnant women contained a gonad-stimulating substance which, when injected into laboratory animals, produced marked gonadal growth. Later, investigators demonstrated with certainty that the Placental Chorionic villi, as opposed to the pituitary, were the source of this hormone. Thus, the name Chorionic Gonadotropin or, in the case of humans, Human Chorionic Gonadotropin (HCG) was given to this hormone of pregnancy. During the more recent past, a broadened variety of studies have been conducted to describe levels of HCG in normal and abnormal physiological states, indicating its role in maintaining pregnancy. The studies have shown the hormone's ability to induce ovulation and to stimulate corpus luteum function and evidence has been evoked for showing its ability to suppress lymphocyte action. The immunological properties of the HCG molecule also have been studied widely. Cross-reaction of antibodies to HCG with human pituitary Luteinizing Hormone (LH), and vice-versa, have been extensively documented, see for example: Paul, W. E. & Ross, F. T. (1964) Immunological Cross Reaction Between HCG and Human Pituitary Gonadotropin. Endrocrinology, Vol. 75, pp. 352-358. Flux, D. X. & Li C. H. (1965) Immunological Cross Reaction Among Gonadotropins. Acta Endocrinologica, Vol. 48, pp. 61-72. Bogshawe, K. D.; Orr, A. H. & Godden J. (1968) Cross-Reaction in Radio-Immunoassay between HCG and Plasma from Various Species. Journal of Endocrinology, Vol. 42, pp. 513-518. Franchimont, P. (1970) Study on the Cross-Reaction between HCG and Pituitary LH. European Journal of Clinical Investigation, Vol. 1, pp. 65-68. Dorner, M.; Brossmer, R.; Hilgenfeldt, U. & Trude, E. (1972). Immunological reactions of Antibodies to HCG with HCG and its chemical derivatives. In Structure-Activity Relationships of Proteins and Polypeptide Hormones (ed. M. Margoulies & F. C. Greenwood), pp. 539, 541 Amsterdam: Exerpta Medica Foundation. Further, these cross-reactions have been used to perform immunoassays for both CG and LM hormones. See: Midgley, A. R. Jr. (1966) Radioimmunoassay: a method for HCG and LH. Endocrinology, Vol. 79, pp. 10-16. Crosignani, P. G., Polvani, F. & Saracci R. (1969) Characteristics of a radioimmunoassay for HCE-LH. In Protein and Polypeptide Hormones (ed. M. Margoulies) pp. 409, 411 Amsterdam: Excerpta Medica Foundation. Isojima, S; Nake, O.; Kojama, K. & Adachi, H. (1970). Rapid radioimmunoassay of human L.H. using polymerized anti-human HCG as immunoadsorbent. Journal of Clinical Endocrinology and Metabolism, Vol. 31, pp. 693-699. In addition to providing for the modification of the entire hormone or selected polypeptide, the invention further provides for the utilization of modified subunits, for example the beta subunit of Chorinonic Gonadotropin. Of particular interest, such subunits may be fragmented into smaller components herein termed "fragments". The latter can be produced synthetically to exhibit an amino acid sequence sufficiently in analogous correspondence to a predetermined portion of the parent subunit. Such fragments generally are conjugated with a larger molecule or component foreign to the body, which may be termed a "carrier", in order to effectively evoke or raise a sufficient quanta of antibodies. The use of the fragments, as thus conjugated, advantageously provides a high degree of specificity of antigenic reaction to the targeted hormone or its biochemical equivalent, i.e. the antibodies will not react with other body constituents. Of particular interest, the above-discussed cross reaction of HCG and LH can be avoided by utilization of fragments of the respective hormone due to the desirable specificity of response thereto. Thus, when interested in obtaining an immunological reaction against the hormone, HCG, the undesirable immune reaction to the naturally occuring body constituent, LH, may be eliminated. Synthetic equivalents of the fragments offer enhanced practicality both from the standpoint of production costs and necessary maintenance of purity. As is indicated in the above discussion, when considered in isolation with respect to conception and pregnancy, CG only is present in female primates when they are in a post conception state. However, as discussed above and later herein, an entity at least analogous thereto (having similar immunological properties to HCG) is seen to be present in conjunction with malignancies. Subunits and fragments of the proteinaceous reproductive hormones include the beta subunit of natural Follicle Stimulating Hormone, the beta subunit of natural Human Chorionic Gonadotropin, fragments including, inter alia, a 20-30 or 30-39 amino acid peptide consisting of the C-terminal residues of natural Human Chorionic Gonadotropin beta subunit, as well as specific unique fragments of natural Human Prolactin and natural Human Placental Lactogen, which may bear little resemblance to analogous portions of other protein hormones. Further with respect to the type of novel chemical entities with which this invention is concerned, one may note for instance the chemical configuration of the beta subunit of HCG. That structure is as follows: ##STR1## For specificity of antibody action it is necessary that distinctive peptides be isolated or prepared that contain molecular structures completely or substantially completely different from the other hormones. The beta-subunit of HCG possesses a specific chain or chains of amino acid moieties which differ either completely or essentially from the polypeptide chain of Human Luteinizing Hormone. These chains or fragments, when conjugated with a carrier, represent an additional aspect of this invention. Accordingly, the polypeptide structures (II) and (III) [C-terminal portion of structure (I)] Asp-Asp-Pro-Arg-Phe-Gln-Asp-Ser-Ser-Ser-Ser-Lys-Ala-Pro-Pro-Pro-Ser-Leu-Pro-Ser-Pro-Ser-Arg-Leu-Pro-Gly-Pro-Ser-Asp-Thr-Pro-Ile-Leu-Pro-Gln Structure (II) Gln-Asp-Ser-Ser-Ser-Ser-Lys-Ala-Pro-Pro-Pro-Ser-Leu-Pro-Ser-Pro-Ser-Arg-Leu-Pro-Gly-Pro-Ser-Asp-Thr-Pro-Ile-Leu-Pro-Gln Structure (III) whether obtained by purely synthetic methods or by enzymatic degradation from the natural or parent polypeptide, [Carlson et al., J. Biological Chemistry, 284 (19), p. 6810, (1973)] when modified according to this invention, similarly provide materials with antigenic properties sufficient to provide the desired immunological response. It will be understood, for example, that additon of a polytyrosine chain or a protein macromolecule (carrier) may assist in rendering structure (II) antigenic so that the resulting administration of modified structure (II) will provide the desired immunological action against natural HCG. The beta subunit set forth at structure (I) is seen to represent a chemical sequence of 145 amino acid components. This structure has a high degree of structural homology with the corresponding subunit of Luteinizing Hormone (LH) to the extent of the initial 110 amino acid components. As incicated above, it may be found desirable, therefore, to evoke a high specificity to the Chorionic Gonadotropin hormone or an analogous entity through the use of fragments analogous to the C-terminal, 111-145 amino acid sequence of the subunit. Structure (II) above may be observed to represent just that sequence. Structure (III) is slightly shorter, representing the 116-145 amino acid positions within the subunit sequence. Further polypeptide chains useful in promoting antibody buildup against natural HCG include the following structures labeled Structures (IV) through (XIV). When modified according to this disclosure, such as by coupling to Ficoll 70* or other modifier-carriers such as protein macromolecules described herein, these polypeptides provide immunogenic activity with which this invention is concerned. All of these polypeptides are considered fragments of HCG by virtue of their substantial resemblance to the chemical configuration of the natural hormone and the immunological response provided by them when modified as indicated herein. Cys-Pro-Pro-Pro-Pro-Pro-Pro-Ser-Asp-Thr-Pro-Ile-Leu-Pro-Gln Structure (IV) Asp-Asp-Pro-Arg-Phe-Gln-Asp-Ser-Pro-Pro-Pro-Pro-Pro-Pro-Cys Structure (V) Phe-Gln-Asp-Ser-Ser-Ser-Ser-Lys-Ala-Pro-Pro-Pro-Ser-Leu-Pro-Ser-Pro-Ser-Arg-Leu-Pro-Gly-Pro-Ser-Asp-Thr-Pro-Ile-Leu-Pro-Gln Structure (VI) Asp-Asp-Pro-Arg-Phe-Gln-Asp-Ser-Ser-Ser-Ser-Lys-Als-Pro-Pro-Pro-Ser-Leu-Pro-Ser Structure (VII) Asp-Asp-Pro-Arg-Phe-Gln-Asp-Ser-Pro-Pro-Pro-Cys-Pro-Pro-Pro-Ser-Asp-Thr-Pro-Ile-Leu-Pro-Gln Structure (VIII) Asp-Asp-Pro-Arg-Phe-Gln-Asp-Ser-Pro-Pro-Pro-Pro-Pro-Pro-Cys-Pro-Pro-Pro-Pro-Pro-Pro-Ser-Asp-Thr-Pro-Ile-Leu-Pro-Gln Structure (VIIIa) A synthetic copolymer of sucrose and epicholorohydrin having an average molecular weight of 70,000±10,000, good solubility in water, Stokes radius about 5.1, stable in alkaline and neutral media. Asp-His-Pro-Leu-Thr-Aba-Asp-Asp-Pro-Arg-Phe-Gln-Asp-Ser-Ser-Ser-Ser-Lys-Als-Pro-Pro-Pro-Ser-Leu-Pro-Ser-Pro-Ser-Arg-Leu-Pro-Gly-Pro-Ser-Asp-Thr-Pro-Ile-Leu-Pro-Gln-Pro-Pro-Pro-Pro-Pro-Pro-Cys Structure (IX) Asp-Asp-Pro-Arg-Phe-Gln-Asp-Ser-Ser-Ser-Ser-Lys-Ala-Pro-Pro-Pro-Ser-Leu-Pro-Ser-Pro-Ser-Arg-Leu-Pro-Gly-Pro-Ser-Asp-Thr-Pro-Ile-Leu-Pro-Gln-Pro-Pro-Pro-Pro-Pro-Pro-Cys Structure (X) Asp-Asp-Pro-Arg-Phe-Gln-Asp-Ser-Ser-Ser-Ser-Lys-Ala-Pro-Pro-Pro-Ser-Leu-Pro-Ser-Pro-Ser-Arg-Leu-Pro-Gly-Pro-Ser-Asp-Thr-Pro-Ile-Leu-Pro-Gln-Cys Structure (XI) Structure (IV) will be recognized as incorporating a Cys component at the amino or N terminal which is associated with a Proline spacer sequence. These spacers serve to position the sequence which follows physically distant from the carrier-modifier. The latter sequence may be observed to represent the 138th to 145th amino acid component sequence of the subunit Structure (I). Structure (V) on the other hand, represents an initial sequence corresponding with the 111th to 118th components of the subunit Structure (I) followed by a sequence of six Proline spacer components and a carboxyl terminal, present as Cysteine. The rationale in providing such a structure is to eliminate the provision of sites which may remain antigenically neutral in performance. Structures (IV) and (V) represent relatively shorter amino acid sequences to the extent that each serves to develop one determinant site. Consequently, as alluded to in more detail hereinafter, they are utilized in conjunction with a mixed immunization technique wherein a necessary two distinct determinants are provided by the simultaneous administration of two such fragments, each conjugated to a corresponding, separate carrier macromolecule. Structure (VI) represents the 115th through 145th component sequence of Structure (I). Structure (VII) represents a portion of Structure (I), however, essentially, a sequence of the 111th to 130th components thereof is formed. Structure (VIII) incorporates two sequences, one which may be recognized in Structure (V) and the other in Structure (IV). These two sequences are separated by two spacer sequences of Proline components and one is joined with an intermediately disposed Cysteine component which serves a conjugation function as described later herein. With the arrangement, two distinct determinant sites are developed in physically spaced relationship to avoid the development of an unwanted artificial determinant possibly otherwise evolved in the vicinity of their mutual coupling. Structure (VIIIa) represents Structure (VIII) with additional Pro spacer residues to provide a widened spacing of determinant sites. Structure (IX) mimics sequences from Structure (I) with the addition of a Proline Spacer Sequence, a Cysteine Component at the C-terminal, and an Aba substituted for Cys at the 110 position. The Aba designation is intended herein to mean alpha-aminobutyric acid of Cysteine. Structure (X) will be recognized as a combination of Structure (II) with a six residue Proline spacer sequence and a Cysteine component at the C-terminal. Similarly, Structure (XI) combines Structure (II) with a Cysteine component at the C-terminal without a Proline spacer sequence. Thr-Cys-Asp-Asp-Pro-Arg-Phe-Gln-Asp-Ser-Ser-Ser-Ser-Lys-Ala-Pro-Pro-Pro-Ser-Leu-Pro-Ser-Pro-Ser-Arg-Leu-Pro-Gly-Pro-Ser-Asp-Thr-Pro-Ile-Leu-Pro-Gln Structure (XII) Asp-His-Pro-Leu-Thr-Aba-Asp-Asp-Pro-Arg-Phe-Gln-Asp-Ser-Ser-Ser-Ser-Lys-Ala-Pro-Pro-Pro-Ser-Leu-Pro-Ser-Pro-Ser-Arg-Leu-Pro-Gly-Pro-Ser-Asp-Thr-Pro-Ile-Leu-Pro-Gln-Cys Structure (XIII) Cys-Pro-Pro-Pro-Pro-Pro-Pro-Asp-Asp-Pro-Arg-Phe-Gln-Asp-Ser-Ser-Ser-Ser-Lys-Ala-Pro-Pro-Pro-Ser-Leu-Pro-Ser-Pro-Ser-Arg-Leu-Pro-Gly-Pro-Ser-Asp-Thr-Pro-Ile-Leu-Pro-Gln Structure (XIV) Structure (XII) will be recognized as having the sequence of Structure (II) with the addition of Thr-Cys components at its N terminal. Structure (XIII) is similar to Structure (IX) but does not contain the spacer conjugate. Structure (XIV) will be recognized as being similar to Structure (II) with the addition of spacer components at the N terminal and a Cys component for conjugation purposes. Particularly where the larger whole hormone or subunit type molecular structures are concerned, the number of foreign reactive groups which are to be attached to the polypeptide and the number of polypeptides to be attached to a foreign reaction group depends on the specific problem being treated. Basically, what is required is that the concerned polypeptide be modified to a degree sufficient to cause it to be antigenic when injected in the body of the host. If too little modification is effected, the body may not recognize the modified polypeptide as a foreign body and would not create antibodies against it. If the number of foreign molecules added to the polypeptide is too great, the body will create antibodies against the intruder antigen, but the antibodies will be specific to the injected antigen and will not neutralize the action of the concerned natural endogenous hormone or non-hormonal protein, i.e. they will be specific to the modifier. In general, again considering the larger molecule subunit or whole hormone, it has been found that about 1-40 modifying groups per molecule of polypeptide will be useful in modifying the polypeptide adequately so as to obtain the desired immunological effect of this invention. As will be appreciated by one skilled in the art, this ratio of modifying groups per polypeptide will vary depending upon whether an entire hormone is utilized for modification or whether for instance a relatively small synthetic fragment of said hormone is to be modified. Generally for the larger molecules, it is preferred that 2-40 modifying groups per molecule of polypeptide be used according to this invention. In the instance where the polypeptide is the beta-subunit of HCG it is particularly preferred that about 5-30 and more preferably 10-26 modifying groups per molecule of polypeptide be used. The important consideration with respect to each modified polypeptide is that the degree of modification be adequate to induce generation by the body of antibodies adequate to neutralize some of the natural hormone or non-hormonal protein against which neutralization is desired, and this will vary with each polypeptide involved, and the degree of correction or change desired for the body function involved. Modification of the polypeptide is accomplished by attaching various kinds of modifying groups to proteinaceous hormone, non-hormonal proteins, subunits or specific fragments thereof according to methods known in the art. As is apparent, Structures (II)-(XIV) are relatively smaller fragments, usually produced synthetically. To render them capable of eliciting antibody production, it becomes necessary to conjugate them with larger carrier-modifier molecules. Generally about 5-30 peptide fragments will be coupled with one carrier molecule. The body will, in effect, recognize these foreign carriers as well as the sequences represented by the fragments and form antibodies both to the carrier and to the sequences of the coupled fragments. Note that the carrier-modifiers are foreign to the body and thus antibodies to them will not be harmful to any normal body constituents. In the latter regard, it may be found preferable to utilize a carrier which, through the development of antibodies specific to it, will be found beneficial to the recipient. As indicated earlier herein, it also is preferred that the modification constitute two or more immunological determinants represented on the native hormone as polypeptide structures to which it is desired to evoke an antibody response. The effect is one of heterogeneity of antibody development. Thus, several fragment structures have been described above having at least two distinct amino acid sequences represented in the HCG beta subunit [Structure (I)]. These sequences may be so spaced as to derive the determinants in mutual isolation, while the spaced sequence fragment is conjugated with a larger, macromolecular carrier. Alternately, the noted mixed immunization arrangement may be utilized wherein a first fragment developing one determinant is conjugated with a first carrier molecule and is administered in combination with a second, distinct fragment which is conjugated with a second carrier molecule, the latter of which may be the same as or different in structure from the first carrier. Thus, each macromolecular carrier must be conjugated with hormone fragments such that each fragment represents two or more immunological determinants. These two necessary determinants can be evolved by mixing, for example, separate conjugate structures, for example Structures (IV) and (V) each of which, through forming antibodies separately to the distinct determinants, will provide a population of antibodies reacting with two separate determinants on the natural endogenous hormone. Inasmuch as the noted fragments are relatively small as compared, for instance, to a whole hormone or subunit thereof, a criterion of size is imposed upon the selection of a carrier. The carrier size must be adequate for the body immune system to recognize its foreign nature and raise antibodies to it. Additionally, carrier selection preferably is predicated upon the noted antibody heterogeneity requirement, i.e. the carrier must itself evoke a heterogeneous immune response in addition to the fragments. For example, improved response may be recognized where the carrier is varied in structure, e.g. incorporating branching chains to enhance the recognition of both the carrier and the attached polypeptide as being of a foreign nature. As one example of whole hormone modification, modified diazo groups derived from sulfanilic acid may be attached to the subject polypeptides, see the Cinader et al and Phillips et al references cited subsequently for instruction on how this "attachment" is accomplished, and to the extent necessary for an understanding of this invention, such is incorporated herein by reference. Additional modifying groups for modifying whole hormones or their subunits are those groups obtained by reaction of the polypeptides with dinitrophenol, trinitrophenol, and S-acetomercaptosuccinic anhydride, while, suited for utilization as a carrier-modifier in conjunction with fragments, are polytyrosine in either straight or branched chains, polyalanines in straight or branched chains, biodegradable polydextran, e.g. polymerized sugars such as sucrose copolymerized with epichlorohydrin, e.g. Ficoll 70 and Ficoll 400* or a polyglucose such as Dextran T 70**, serum proteins such as homologous serum albumin, hemocyanin from Keyhole limpet, a marine gastropodmollusk, viruses such as influenza virus (type A, B, or C) or poliomyelitis virus, live or killed, Types 1, 2 and 3 of tetanus toxoid, diphtheria toxoid, cholera organisms or somewhat less preferably, natural proteins such as thyroglobulin, and the like. Generally, synthetic modifiers are preferred over the natural modifiers. However, carrier-modifiers found particularly suitable for conjugation with the above-discussed fragment structures are Flagellin, tetanus toxoid and an influenza subunit, for example, the preparation of which is described by Bachmeyer, Schmidt and Liehi, "Preparation and Properties of a Novel Influenza Subunit Vaccine", Post-Graduate Medical Journal (June, 1976) 52:360-367. This influenza subunit was developed as a vaccine which incorporates essentially only the two viral proteins, Haemagglutinin and Neuraminidase. Containing substantially only these two essential immunogens, the subunit represents a preparation which does not contain other protein and lipid antigens which may be found to cause undesired side reactions. A secondary benefit may be realized through the utilization for example, of the influenza subunit, *Pharmacia Fine Chemicals, Pharmacia Laboratories, Inc. 800 Centennial Ave., Piscataway, N.J. 08854. A synthetic copolymer of sucrose and epichlorohydrin having an average molecular weight of 400,000±100,000 intrinsic viscosity of 0.17 dl/g. specific rotation [α] D 20 of +56.5° Flagellin is a protein described as forming the wall of the main spiral filament of the flagellum. Bacterial flagella, in turn, have been known as the active organelles of cell locomotion, individual flagella (flagellum) occurring in suspension as individual spirals which, upon drying, collapse into filaments which describe a sine wave with a wave length of 2-3 microns and an amplitude of 0.25-0.60 microns. Generally, the flagellum consists of three morphologically distinct parts: a basal structure that is closely associated with the cytoplasmic membrane and cell wall, a hook and the noted main spiral filament. Purified flagellum is readily obtained by solubilization of flagellar filaments below a pH value of about four, and subsequent removal of the insoluble material by centrifugation or filtration. As a group of related proteins, flagellins from different bacterial species have been predicted to have similar amino-acid compositions. However, the amino acid composition of each flagellin species is unique. Essentially all flagellins are described as containing no or only a few residues of cysteine, tryptophan, tyrosine, proline and histidine. Thus, when conjugated with fragments in accordance with the invention, a thiolactonization procedure or the like is carried out as described later herein. The molecular weights of various flagellin have been calculated, in all cases the values thereof of the monomeric subunits falling in the range of 30,000 to 50,000. From an immunological standpoint, a flagellin molecule is highly immunogenic. For a further and more detailed discourse describing bacterial flagella and flagellin, reference is made to "Advances in Microbial Physiology" 6:219 1971, "Bacterial Flagella" by R. W. Smith and Henry Coffler, which publication is incorporated herein by reference. Tetanus toxoids have been the subject of study and production for many years. The toxoid generally is evolved from a formalinization of tetanus toxin, the latter being a protein synthesized by Clostridium tetani. Immunization currently is carried out utilizing soluble and absorbed tetanus toxoids and suggestions have been made concerning the utilization of fluid tetanus toxoid in complex with antitoxin. Publications describing the toxin and toxoid are numerous, reference being made to the following: 1. Immunochemistry of Tetanus Toxin, Bizzini, et al, Journal of Biochemistry, Vol. 39, pp. 171-181 (1973). 2. Early and Enhanced Antitoxin Responses Elicited with Complexes of Tetanus, Toxoid and Specific Mouse and Human Antibodies, Stoner et al, Journal of Infectious Diseases, Vol. 131, No. 3, pp. 230-238 (1975). 3. Differences in Primary and Secondary Immunizability of Inbred Mice Strains, Ipsen, Journal of Immunology, Vol. 83, pp. 448-457 (1959). 4. Antigenic Thresholds of Antitoxin Responses Elicited in Irradiated Mice with Complexes of Tetanus Toxin and Specific Antibody, Hess et al, Radiation Research, Vol. 25, pp. 655-667 (1965). 5. Early and Enhanced Germinal Center Formation and Antibody Responses in Mice After Primary Stimulation with Antigenisologous Antibody Complexes as Compared with Antigen Alone, Laissue et al, Journal of Immunology, Vol. 107, pp.822-825, (1971). 6. Distinctive Medullary and Germinal Center Proliferative Patterns in Mouse Lymph Nodes after Regional Primary and Secondary Stimulation with Tetanus Toxoid, Buerki et al, Journal of Immunology, Vol. 112, No. 6, pp. 1961-1970 (1974). Modification by removal of moieties is also contemplated by this invention. Thus, for example, where certain of the natural proteins have carbohydrate moieties, these carbohydrate moieties may be removed according to methods known in the art by, for instance, N-acetyl neuriminidase of N-acetyl glucosidase, materials useful for removal of specific carbohydrate moieties. These various means for modification are, as indicated above, known to persons skilled in the art. Certain of these means may be found in the following list of literature references, whereas various others of them may be found elsewhere in the literature by art-skilled persons: (1) Klotz et al., Arch. of Biochem. and Biophys., 96, pp. 605-612, (1966). (2) Khorana, Chem. Rev. S3: 145, (1953). (3) Sela et al., Biochem. J., 85, p. 223, (1962)- (4) Eisen et al., J. Am. Chem. Soc. 75, 4583, (1953). (5) Centeno et al., Fed. Proc. (ABSTR) 25; 729, (1966). (6) Sokolowsky et al. J. Am. Chem., Soc. 86: 1212, (1964)- (7) Tabachnick et al., J. Biol. Chem. 234, No. 7, p. 1726, (1959). (8) Crampton et al., Proc. Soc. Exper. Biol. & Med. 80: 448, (1952). (9) Goodfriend et al., Science 144, p. 1344 (1964). (10) Sela et al., J. Am. Chem. Soc., 78, p. 746, (1955). (11) Cinader et al., Brit. of Exp. Pathol. 36, p. 515, (1955). (12) Phillips et al, J. of Biol. Chem. 240 (2), pp. 699-704, (1965). (13) Bahl, J. of Biol. Chem., 244, p. 575, (1969). Methods for preparing the modified polypeptides of this invention also include the following. In one preferred modification approach, the polypeptide fraction, for example, Structure (XII), is activated first following which is conjugated with a carrier, for example the influenza subunit described above, tetanus texoid or Flagellin. An activating reagent may be utilized which exhibits differing functionality at its ends and by choice of reaction conditions, these end components can be made to react selectively. For example, the following activator A and B, having a maleiimido group and a substituted acid group, may be provided: ##STR2## where X is a non-reacting group made up of a substituted, or unsubstituted phenyl or C 1 -C 10 alkalene moiety, or a combination thereof. In this regard, the moiety substituted on the phenyl should be non-interfering as is the remainder of the "X" grouping. X may, inter alia, be selected from the following: ##STR3## The maleiimido grouping of the above reagents will react with sulfhydryl (SH) groups in the polypeptide fragments under conditions whereby the opposite end (active ester end) of the reagent does not react with the amino groups present in the fragment sequences. Thus, for example, polypeptide fragments such as Structure (XII), containing a Cys amino acid and hence, an SH group react as follows: ##STR4## Following the above, upon adjusting the pH to a slightly alkaline condition, e.g. 8, and adding the carrier protein accomplishes the following conjugation: ##STR5## Alternately, a carrier protein such as the above-noted Flagellin which does not contain SH groups, but does contain NH 2 groups, may first be treated with activator A or B at pH 7 or lower at the active ester end, giving: ##STR6## Following the above, the activated carrier is reacted with a polypeptide fragment containing an SH group to derive a product similar to that discussed immediately above. Should the polypeptide fragment not contain an SH group, e.g. Structures (II), (III), (VI) and (VII), such structures can be modified first to introduce such a grouping by standard methods such as "thiolactonization", following which they are conjugated utilizing the above-discussed selective bi-functional reagents. For a more detailed description of these reagents, reference is made to the following publications: O. Keller and J. Rudinger, Helv. Chim. Acta 58, 531-541 (1975). W. Trommer, H. Kolkenbrock & G. Pfleiderer, Hoppe-Seyler's Z. Physiol. Chem., 356, 1455-1458 (1975). Further description of preferred embodiments of the above-described utilization of bi-functional reagents is provided hereinbelow at Examples XXVII and XXVIII. As an alternate approach to the utilization of the maleiimido group reagents discussed above, an alkylation step may be used to cause conjugation. Conditions can be chosen such that in the presence of amino groups, essentially only SH groups will be alkylated. With this approach, a generalization of the reactions carried out may be expressed as follows: ##STR7## With this approach, the larger molecule carrier, e.g. Flagellin, tetanus toxoid or the influenza subunit described herein is first modified by reaction of a fraction of its amino groups with an active ester of chloro, dichloro, bromo or iodo acetic acid, such as: ##STR8## and this modified carrier is then reacted with the sulfhydryl group in a polypeptide fraction, or a polypeptide fraction which has been modified to contain the SH group (e.g. thiolactonization) if it does not already have such a group. Such modification is described in Example XXV below. The present approach produces a thio ether linkage by alkylation of a free thiol (sulfhydryl group). With the instant procedure, the roles of the fragment and carrier may be reversed, the fragment being modified to contain the halomethyl alkylating group which would then react with sulfhydryl groups in the carrier, or a carrier suitably modified to exhibit a sulfhydryl group. More description of this selective alkylation of sulfhydryl groups is provided in conjunction with Example XXX below. It may be seen from an observation of the formulae of Structures (IV), (V), (IX), (X), (XI), (XII), (XIII) and (XIV) that a Cys amino acid, which in a reduced state provides an SH reactive group, is located at either the C terminal or N terminal of the peptide structure. This location permits the peptide to be chemically linked to carrier molecules at either terminus. And some Structures (XIV), (X), (IX), (X), (IV) have a six-proline spacer chain (Pro) 6 between the Cys residue and the remainder of the peptide sequence. This latter arrangement provides a chemical spacer between the coupled carrier and the sequences representing a fragment of the natural hormone. A six-proline spacer can be added as a side chain spacer, for example at position 122 (Lys) in Structure (II), by initially adding an SH group (thiolactonization) to the free or unblocked epsilon amino group on this (Lys) residue, as set out in Example XXIX below. Then, utilizing the activator A,B above in which the component "X" is a chain of six proline amino acid, conjugation can be carried out. In the latter case, a spacer is provided between the carrier and peptide linked at an intermediate site, for example at position 122 in Structure (II). In the former case, only the space represented by conjugating reagent links the carrier and peptide. Modifying groups, such as hemocyanin from Keyhole limpet, containing free amino groups, are prepared in buffer solution such as phosphate buffer, is sodium chloride solution at a pH of 6-8. To this solution, tolylene diisocyanate (T.D.I.C.) reagent diluted from about 1-10 to about 1-40 times with dioxane, is added to the modifying group. The general procedure was disclosed by Singer and Schick, J. Biophysical and Biochem. Cytology 9:519 (1961). The amount of T.D.I.C. added may range from 0.075 to 1,000 molar equivalents of the modifier used. The reaction may be carried out at about -5° to about +10° C., preferably 0° to 4° C., for about 1/2 to 2 hours. Any excess T.D.I.C. may be removed by centrifugation. The precipitate may be washed with the above-mentioned phosphate buffer and the supernatants combined. This activated modifying group solution may then be combined with the hormonal or non-hormonal polypeptide to be conjugated. Polypeptide is dissolved n the same phosphate buffer (5-30 mg/ml) and the volume of modifier and polypeptide combined according to the molar ratio of the two desired in the conjugate. Combined solutions are reacted at 30°-50° C., preferably 35°-40° C., for 3-6 hours. Separation of modified polypeptide and free unconjugated polypeptide may be accomplished by conventional techniques, such as gel filtration. Picogram amounts of I 125 labeled polypeptide may be added as a tracer to the reaction mixture at the time of conjugation, and a quantity of polypeptide conjugated to modifying groups (molar ratio) may be determined by the amount of radioactivity recovered. Included in the methods for modifying the hormones, non-hormonal proteins and their fragments (unmodified polypeptides) are conjugation by use of water-soluble carbodiimide. The amino groups of the unmodified polypeptide are first preferably protected by acetylation. This (acetylated) unmodified polypeptide is then conjugated to modifier, such as natural protein modifier, e.g. hemocyanin from Keyhole limpet, homologous serum albumin, and the like, or Dextrans, Ficolls, or polytyrosine, preferably in the presence of guanidine such as guanidine HCl, using 10-ethyl-3-(3-dimethylamino propyl) carbodiimide as activating agent. This method is generally disclosed by Hoare and Koshland, Jr., J. of Biological Chemistry 242:2447 (1967). In the instance where Ficoll 70 is used, it is preferred that it be first treated with ethylene diamine so as to render the final coupling more efficient. This treatment with ethylene diamine may be performed in solvent such as saline and dioxane at about room temperature and a pH of about 9-12, preferably 10-11 for about 1/4 to about 2 hours. The conjugation itself between the umodified polypeptide and the modifier may be performed in solvent such as glycine methyl ester while maintaining the pH at about 4-5, preferably about 4.5-4.8. The temperature or reaction is conveniently about room temperature and the reaction may be allowed to proceed for about 2-8 hours, preferably 5 hours. The resulting modified polypeptide with which this invention is concerned may be purified by conventional techniques, such as column chromatography. The immunogenic substances for this invention may also be provided by polymerization or unmodofied polypeptide using bifunctional imidoester. The imidoester, such as dimethyl adipimidate, dimethyl suberimidate and diethyl malonimidate, may be used to form the polymer in a manner similar to the generally described methods of Hartman and Wold; Biochem. 6:2439 (1967). The polymerization may take place conveniently at room temperature in aqueous solvent at a pH of about 9-12, preferably about 10-11, over a period of 1/4-2 hours. Said immunogenic substances may also be prepared by dimerization through a disulfide bond formed by oxidation of the thiol group on a Cys-residue using iodosobenzoic acid and methods corresponding to known methods, such as room temperature reaction for about 10-40 minutes. Modified polypeptide may also be prepared using glutaric dialdehyde as conjugating agent. According to a theory proposed by Richards and Knowles [J. Mol. Biol. 37:231 (1968)], commercial glutaric dialdehyde contains virtually no free glutaric dialdehyde, but rather consists of a very complex mixture of polymers rich in α,β-unsaturated aldehydes. Upon reaction with natural protein modifiers such as homologous serum albumins, these polymers form a stable bond through the free amino group, leaving aldehyde groups free. This intermediate product then reacts with unmodified polypeptide in the presence of alkali metal borohydride, such as sodium borohydride. This intermediate is formed at pH 7-10, preferably 8-9, at about room temperature. The modified polypeptide is also conveniently obtained at about room temperature after about 1/4-2 hours' reaction time. The resulting product is recovered in pure form by conventional techniques, such as gel filtration, dialysis and lyophilization. Polymerized sugar modifiers such as Ficoll 70 or Dextran T 70 may also be prepared for conjugation by treatment with a cyanuric halide such as cyanuric chloride to form a dihalotriazinyl adduct. The process may be performed in solvent such as dimethylformamide at about 0°-20° C., preferably 10°-15° C., for about 1/2-4 hours. The resulting intermediate product may then be dialyzed until essentially halogen ion free, and lyophilized and treated with unmodified polypeptide at pH 8-11, preferably about 9-10, for about 1/2-12 hours at about 15°-35° C., conveniently at room temperature. The resulting modified polypeptide may be recovered as indicated above. Said polymerized sugar modifiers may also be treated with alkali metal periodate, such as sodium periodate, at a pH of 3-6 at about 30°-60° C. for about 1/2-4 hours, and the resulting intermediate conjugated with unmodified polypeptide at a pH of about 7-11, preferably about 8-10, for about 1/4 to about 2 hours at a temperature of about 15°-80° C., preferably 20°-60° C. The resulting immunogenic substance according to this invention may be separated as indicated previously. The modifying groups may vary in chemistry and number for any given polypeptide structure. However, they will attach to only certain amino acid moieties. In particular, when modifying with diazo groups they will chemically bond to only the histidine, arginine, tyrosine and lysine moieties or sites. Other modifying groups will bond to peptide molecules at different sites and in different numbers. Consequently, depending upon the size and chemical make-up of a particular modified polypeptide desired, one skilled in the art will readily be able to calculate the maximum possible number of modifying groups associable with a polypeptide. It is also recognized that several modifying groups may attach themselves to each other which in turn attach to a single amino acid moiety, but as used herein, reference to a number of modifying groups means the number of reaction sites to which a modifier has been attached. As indicated above, a theory leading to this invention was that the chemical modification of an essential reproductive hormone would alter it such that it would exhibit antigenic properties so that when injected into an animal (including humans) it would cause the formation of antibodies which in turn would not only react to the injected modified hormone but also to the natural unmodified endogenous hormone as well. With this theory in mind, reproductive hormones of various species were modified and tested in baboons. The results illustrated that modified hormones of unrelated species do not produce the desired results, whereas modified hormones of the same or closely related species do produce the desired results. It will accordingly be clear that the polypeptide to be modified should be so related to the endogenous hormone or non-hormonal protein so as to be either from the same animal species or be the immunological equivalent thereof as modified. Additional experiments were conducted to test the validity of this concept in humans, i.e. modified human reproductive hormones injected into humans. Collectively, the results prove the conclusion drawn from the experiments with the baboons, namely, isoantigenic immunization using modified human reproductive hormones does produce contraception or interruption of gestation. Detailed examples which follow illustrate this result. It is known that fragments of endogenous hormones exhibit essentially no antigenic properties. However, should a large enough fragment of an endogenous hormone be slightly modified as indicated above, then antibodies will be formed which will react in the same way as if the modification is on a whole hormone, provided the large fragment is sufficiently distinctive in chemical and physical make-up as to be recognized as a specific part of the whole. Whether the hormone or specific fragment thereof is naturally occurring or is a synthetic product is clearly immaterial. A synthetic hormone molecule will perform the same function as the naturally occurring one, being equivalent for the purpose of this invention. In this connection, it will be noted that natural substances with which this invention is concerned possess carbohydrate moieties attached at certain sites thereof whereas the contemplated corresponding synthetic polypeptides do not. Nevertheless, for the purpose of the instant specification and claims, the synthetic and natural polypeptides are treated as equivalents and both are intended to be embraced by this invention. Reference in the above regard is made to Table No. 3 herein as read in conjunction with Example XXIX. Thus, where the word "hormone" or "hormone molecule" is used herein, the word "synthetic" may be added before "hormone" without changing the meaning of the discussion. Similarly, the word, "fragment" may be inserted after "hormone" or "molecule" without changing the meaning, whether or not "synthetic" has been inserted before "hormone". Throughout the above specification, the term "modified" has been utilized in referring to the chemical reaction by which the foreign molecules become chemically attached to specific sites on the usually much larger polypeptide molecule. Although specific mechanisms by which this is accomplished are described herein in detail, other appropriate mechanisms may be used if desired. It is clear that the modifier, i.e., the substance which modifies the concerned protein, can be a physically larger molecule or fragment thereof than the molecule or fragment which it modifies. As noted above, such large molecules are deemed herein to be "carriers". Clearly, physical size of the fragment is not always critical; the criterion for effectiveness being that the body reaction generate antibodies in sufficient quanta and specific to the targeted hormone or endogenous substance. The modified polypeptides of this invention may be administered parenterally to the animals to be protected, preferably with a pharmaceutically acceptable injectable vehicle. They may be administered in conventional vehicles with other standard adjuvants, as may be desirable, in the form of injectable solutions or suspensions. As indicated earlier, the adjuvant serves as a substance which will elevate total immune response in the course of the immunization procedure. Lipasomes have been suggested as suitable adjuvants. The insoluble salts of aluminum, that is, aluminum phosphate or aluminum hydroxide, have been utilized as adjuvants in routine clinical applications in man. Bacterial endotoxins or endotoxoids have been used as adjuvants as well as polynucleotides and polyelectrolytes and water soluble adjuvants such as muramyl dipeptides. The adjuvants developed by Freund have long been known by investigators, however, the use thereof is limited to non-human experimental procedures by virtue of a variety of side effects evoked. The preferred mode of administration of the entire vaccine is intramuscular. The amount of modified polypeptide to be administered will vary depending upon various factors, including the condition being treated and its severity. However, in general, unit doses of 0.1-50 mg in large mammals administered one to five times at intervals of one to five weeks provide satisfactory results. Primary immunization may also be followed by "booster" immunization at one to twelve month intervals. DESCRIPTION OF THE PREFERRED EMBODIMENTS EXAMPLE I Adult female baboons were studied for at least one menstrual cycle for patterns of urinary estrogens, plasma, progestin, and in some cases urinary LH. Only those animals displaying normal patterns of these hormones were immunized. The criteria for normality and the procedures for housing animals are well known and will not be described. Gonadotropin Preparations Human Luteinizing Hormone (HLH)--partially purified preparation from human pituitaries with a biological potency of 2.5 units per mg. (NIH-LH-SI). Human Follicle Stimulating Hormone (HFSH)--a partially purified preparation from humand pituitaries with a biological potency of 86 units per mg. (NIH-FSH-SI). Human Chorionic Gonadotropin (HCG)--a highly purified preparation from human pregnancy urine with biological potency of 13,200 IU/mg. (2nd IRP-HCG). Monkey Luteinizing Hormone (MLH)--a crude preparation from rhesus monkey pituitaries with a biological potency of 0.75 units per mg. (NIH-LH-SI). Ovine Luteinizing Hormone (OLH) (NIH-LH-S5). Baboon Luteinizing Hormone (BLH)--partially purified baboon pituitary preparation with a biological potency of 1.1 units per mg. (NIH-LH-S1). All preparations, excepting the OLH, were prepared in the inventor's laboratory. LH and HCG biological activity was determined by the ovarian ascorbic acid depletion test and the FSH preparation assayed by the ovarian augmentation assay. Hormones were altered as antigens by coupling with a hapten in varying ratios of hapten to hormone as described by Cinader et al., supra. For convenience, the Cinader process is discussed herein although Phillips, supra, may provide a more stable bond under certain circumstances. In this procedure, the protein hormone serves as a carrier and the hapten is coupled to it by diazo bonds. Although a variety of hapten groups were coupled to different hormones, the same basic procedure was used for any combination. Fifteen to thirty-five haptenic groups per hormone molecule were found most useful for preparing immuizing antigens. The basic reaction consisted of diazotizing the hapten (sulfanilic acid) by adding it to a solution of 0.11 N HCl and then slowly adding this solution dropwise to a 1 percent solution of NaNO 2 with constant stirring at 4° C. Diazotization was considered complete with free HNO 2 was detected in the reaction mixture. Although the above reaction was accomplished at 4° C., optimum temperatures for the reaction normally are about 0°-6° C., although 4° C. is preferred. The hapten-protein coupling was performed by dissolving the protein hormone in an alkaline buffer, pH 8.0. The diazotized hapten was added slowly to the hormone solution with continuous stirring at 4° C. The pH of the reaction was constantly monitored and kept near 8.0. After all the hapten was added, the pH was finally adjusted to 8.0, stirred for 1-2 hours and allowed to stand at 4° overnight. The mixture was thoroughly dialyzed for 6-8 days against distilled water to remove unreacted hapten. Although the number of diazo groups per hormone molecule could be regulated by the number of moles of hapten and hormone reacted, a parallel control experiment with S 35 labelled sulfanilic acid to evaluate the precise composition of the haptenprotein samples was performed with each diazotization. The same hormone preparation to be used for immunization was used in the control experiment. After the reaction was completed, an aliquot was taken from the reaction mixture and the remainder thoroughly dialyzed. Equal volumes of the dialyzed and undialyzed solutions were counted by liquid scintillation. By comparing the counts of the dialyzed and undialyzed samples, the moles of hapten coupled to each mole of hormone was calculated since the unreacted hapten was removed by dialysis. For this calculation, a molecular weight of 30,000 was assumed for all gonadotropin preparations. Following dialysis, hapten-hormones were lyophilized and stored at 4° C. Diazo-HCG (35 groups/molecule) and HLH (26 groups/molecule) were bioassayed by the ovarian ascorbic acid depletion method and found to retain 62 and 85 percent respectively of the activity of the unaltered hormones from which they were derived. None of the other hormones were assayed for biological activity. Immunization Procedures Female baboons received their initial immunization on days 3-5 of the menstrual cycle and the second and third injections one week apart. The fourth injection was given 2-3 weeks after the third. A few animals received a fifth injection at 70-80 days after the first injections. All antigens were administered subcutaneously in a suspension of mannide manoleate or peanut oil. Doses of antigens for each injection varied between 3 and 5 mg. Injection sites were inspected daily for 5 days after each immunization for local reactions. Monitoring Effects of Immunization. Daily 24-hour urine specimens and frequent serum samples were collected during at least one menstrual cycle prior to immunizations and following immunizations until the effects of treatment were assessed. Urinary LH, urinary estrogens and plasma progestins were measured. Antibodies were detected in post-immunization serum samples by reacting 0.2 ml. of a 1:1000 dilution of serum in phosphate-buffered saline (pH 7.4) 0.5 percent normal baboon serum with 250 pg of 1 131 labelled hormone. Sera were reacted with both the unaltered immunizing hormone and unaltered baboon LH for antibody detection. A purified baboon LH preparation (1.9×NIH-LH-S1) was used as a tracer antigen. Antigen-antibody complexes were precipitated with ovine anti-baboon gamma globulin after a 24-hr. incubation at 4° C. Antibody levels were expressed as pg of labelled hormone bound. Significant antibody levels were considered to be those that would bind 5.0 pg or more of the 1 131 labelled antigen. Antisera were fractionated by gel filtration of Sephadex G-200 according to the procedure of Fahey and Terry (at p. 36, Experimental Immunology, F. A. Davis Co., Philadelphia, Pa., 1967, incorporated by reference to the extent necessary to understand the invention) to determine the proportion of IgM and IgG antibodies in the baboon sera. Since the IgG fraction in this procedure contained a portion of IgA and IgD antibodies, only IgM and total titers were determined. The IgM fraction from the column was reacted with 1 131 hormones and the binding capacity determined. The volumes of the fractionated sera were adjusted so that antibody levels would be comparable to those of whole serum. Antibody Production No significant reactions were observed at the site of injection following any immunization. On 4 occasions, a slight induration (2-3 cm in diameter) was seen when mannide manoleate was used as a vehicle but the redness and swelling disappeared within 4-5 days. Antibodies were detected against the immunizing antigen within 3-5 weeks in all animals. The extent, duration and cross reactivity of these antibodies is recorded. Generally speaking, higher levels were observed to heterologous gonadotropin immunization than to homologous ones. The cross-reactivity of induced antibodies with baboon LH was studied on each animal. Cross-reactivity of antisera at peak levels was recorded. Although relatively high antibody activity against human LH and HCG were seen, relatively little reaction with baboon LH occurred. An intermediate cross-reaction was noted with anti-ovine LH and a high degree of cross-reactivity was seen with anti-monkey LH. Diazo-human FSH was weakly antigenic in the baboon. The duration of antibody production was generally longer with the human and sheep gonadotropin immunization than with those of monkey or baboon origin. Peak antibody levels usually occurred at the time when the antibodies had shifted to principally the IgG type. Early antibodies had a larger proportion of IgM type and were generally more cross-reactive with baboon LH. The change in the proportion of the total antibody population that was IgM was recorded from the time antibodies were first detected. Significant cross-reactivity to baboon LH was observed in anti-human gonadotropins when IgM was abundant but dropped sharply as the antisera shifted to nearly all IgG. This drop in cross-reactivity did not occur with monkey and baboon immunizations. Again, the ovine LH immunizations produced an intermediate change in reactivity with the shift from IgM to IgG. Effects on the Menstrual Cycle The effects of immunization upon the event of the menstrual cycle were determined by observing changes in sex skin turgescence and levels of pituitary and/or ovarian hormones. Based on these parameters, the delay or retardation of ovulation from the expected time, as judged by the control cycle, was calculated. One animal immunized with HCG had no interruption in ovulation and another immunized with HFSH was delayed for only one cycle. Two animals injected with HLH and two injected with HCG had ovulation delays equivalent to two menstrual cycles. A third animal immunized with HLH was delayed a calculated 86 days. Ovine LH immunizations produced an 88 day delay in ovulation. Immunizations with diazo-monkey or baboon LH resulted in longer disruption of the menstrual cycle. Calculated delays in ovulation for the two animals receiving monkey LH was 146 and 122 days whereas the animals receiving altered baboon LH were retarded from ovulation 224 and 210 days. Effects on specific hormone patterns following immunization with HLH in one animal were recorded. The interval between menses was considered to represent a "cycle". Urinary estrogens and plasma progestin patterns indicated that no ovulation occurred during the cycle of immunization which was 85 days in duration. Urinary estrogens were elevated during treatment but did not reflect a typical pattern. Plasma progestins were not elevated until about day 19 of the final post-treatment cycle. Patterns of both estrogens and progestins were within normal limits during the second post-treatment cycle. Antibody levels were elevated from about day 35 of the treatment cycle until 289 days from the first detection of antibodies. An LH assay was not available when this animal was studied and no data on plasma or urinary levels of this hormone was obtained. Hormonal patterns following an immunization with diazobaboon LH were recorded. In this animal, antibody levels were lower and persisted, in general, for a shorter period than did immunizations with human gonadotropins. During the treatment cycle, levels of urinary estrogens and plasma progestins followed a normal pattern but were quantitatively lower than normal. Urinary LH patterns fluctuated markedly due to the injections of diazo-LH during this period. No conclusive evidence of ovulation was obtained for the treatment cycle. The first post-treatment cycle lasted 246 days. During this cycle urinary LH and estrogens were elevated on days 35-41 but there was no subsequent elevation in plasma progestins that would indicate ovulation had occurred. Following day 42 of this cycle, there was no significant elevation in any of the three hormone levels until day 231 when significant elevations of urinary estrogens and LH occurred. These rises were followed 3 days later by an elevation in plasma progestins indicating the presence of a functioning corpus luteum. A second post-treatment menstrual cycle was of normal duration and the endocrine patterns were normal. Antibodies to unaltered baboon LH attained maximum levels by about day 70 of the post-treatment cycle and remained relatively constant until day 190 when a steady decline was observed. By day 215 of this cycle, antibody levels were barely detectable. Approximately 16 days after this time, a peak of LH commensurate with a normal midcycle elevation was observed. From this point the animal appeared to have the normal function of the pituitaryovarian axis. Hormonal patterns in animals with other heterologous gonadotropin immunizations were similar to animal receiving HLH and other animals receiving monkey or baboon LH were similar in response to animal receiving baboon LH. These results in baboons indicated that the modification of a reproductive hormone, by the procedures outlined, did render it antigenic and the antibodies thus formed did neutralize natural endogenous hormones if the natural hormone was obtained from the species receiving the immunizations with modified hormone. EXAMPLE II HCG is a hormone naturally present only in pregnant women with the exception that an entity at least analogous thereto has been found to be present in humans in conjunction with neoplasms. HCG is also commercially available. Human LH is immunologically and biologically identical to HCG, even though there are chemical differences. Since they are biologically identical and HCG is readily available from commercial sources it was presumed that the effectiveness of this immunological procedure could be evaluated by injecting modified HCG into non-pregnant women and monitoring the blood levels of LH. Antibodies formed will neutralize both the LH and the modified HCG. Reference in the above regard is made to the publications identified earlier herein. Women have a pattern of LH levels; the level is substantially constant until the middle period between menstrual cycles, immediately prior to ovulation; at that point the LH level rises greatly and helps induce the ovulation. Monitoring the LH level and the antibody level will show that the procedure used did or did not cause the production of antibodies capable of neutralizing the endogenous reproductive hormone, namely LH. A women aged 27 years was selected for study. Hormone was obtained, purified and modified. The modified human hormone (HCG) was injected into the subject. It is well known that antibodies to HCG react identically to LH as well as HCG. The effect of the immunization was evaluated, principally by monitoring blood levels of LH. Finally the results were evaluated. Preparation of Hormone Clinical grade HCG derived from pregnancy urine was obtained from the Vitamerican Corp. Little Falls, N.J. This material has an immunological potency of 2600 IU/mg. Contaminants were detected in this preparation. Purification consisted of chromatography and elution. Fractions were dialyzed and lyophylized. The most potent fraction contained approximately 7600 IU/mg., however, it was heterogenous on polyacrylamide gel electrophoresis. The fraction was further purified by gel filtration. The elution profile revealed two major protein peaks. The most potent HCG was found in the first peak and had an immunological potency of 13,670 IU per mg. This fraction was subjected to polyacrylamide gel electrophoresis. Further purification by gel filtration showed no evidence of heterogeneity of the HCG at this stage. Consequently, materials for study were processed according to the above procedure. The contamination of this purified HCG was tested with I 131 used for identification and a sample was reacted with antisera against several proteins offering potential contamination. Those proteins were follicle stimulating hormone, human growth hormone, whole human serum, human albumin, transferin, alpha one globulin, alpha two globulin and orosomucoid. No detectable binding of the purified HCG was observed with any antisera at a dulution of 1:50 of each. These negative results, calculated against potential binding of the respective proteins, indicated that contamination with any was less than 0.005 percent. Alteration of Hormone Hormone was altered by coupling with a hapten (sulfanilazo). This method couples the hapten molecules to the protein via the amino group of the aliphatic or aromatic portion of the hapten. The number of hapten molecules coupled to each HCG molecule (Ha-HCG) can be regulated and for this study, forty haptenic groups per HCG molecule were used for preparing the immunizing antigen. Following the hapten-coupling process, the Ha-HCG was sterilized and tested. Subject The subject was multiparous and had terminated her reproductive capabilities by prior elective bilateral salpingectomy. She was in good health and had regular cyclic menstruation. She underwent complete history, physical examination and laboratory evaluation including blood count, urinalysis, latex fixation and Papanicolau smear. She had no history of allergy. To demonstrate normal functioning of the pituitaryovarian axis prior to immunization, blood samples were obtained every other day from the first day of menses for 10 days, then daily for 10 days and finally, every other day until the next menses. Serum determinations of FSH, LH, estrone, estradiol and progesterone were performed. These studies indicated an ovulatory pattern. Immunization Procedures Ten mg. of the Ha-HCG antigen were dissolved in 1.0 ml. of saline and emulsified with an equal volume of oil. Prior to injection, scratch tests to antigen and vehicle were performed. Immunizations were begun in the luteal phase of the treatment cycle to prevent superovulation from the administered HCG. Four injections at two week intervals were given to the subject. The first two of these were administered in oil subcutaneously (1.0 ml. in each upper arm); the final two injections were given in saline only via the intradermal route. Following each injection, blood pressure readings were taken and the subject observed for allergic reactions. Monitoring Effects of Immunizations Blood samples were collected at weekly intervals beginning two weeks after the initial injection to test for the presence of humoral and cellular antibodies. Following completion of the immunization schedule, blood samples were collected in the same manner as in the control cycle to assess effects of immunization on hormonal patterns of the menstrual cycle. Since antibodies to HCG react identically to LH as with HCG, LH was monitored as an index of effectiveness of the procedure. A third cycle was similarly studied six months after initial immunization. Upon completion of the study, physical and pelvic examinations and laboratory evaluations were repeated. Serum samples from the control and post-treatment cycles were assayed for FSH, LH, estrone, estradiol and progesterone. The subject was tested for delayed hypertensivity before immunization and at two week intervals until the injection schedule was completed by an in vitro lymphocyte transformation test. Results Temporal relationships of serum pituitary and gonadal hormones in the control cycles of the subject were recorded. Antibody titers to HCG were detected in the subject after two injections. Menses occurred at regular intervals during the immunizations. Following the initial injection in mannide manoleate, some itching and swelling at the injection site occurred. Subsequent intradermal injections in saline produced no reactions and it was concluded that the local reactions were induced by the mannide manoleate. Lymphocyte transformation tests on plasma samples were negative. In the post-treatment cycle, baseline follicular and luteal phase LH levels were not noticeably changed in the subject. Very small midcycle elevations in LH levels were observed as compared to the normal large increases. FSH patterns in the post-treatment cycle were normal. This indicated that the antibodies were neutralizing the action of endogenous LH. The subject showed an ovulatory progesterone pattern but attained relatively high antibody titers to LH and HCG after only two injections of Ha-HCG. The subject was studied during another cycle approximately six months from the first immunization. Significant antibody titers were found. LH patterns indicated a small midcycle elevation. FSH patterns were essentially normal. Thus, the specificity of anti-HCG antibodies to LH was shown but not to FSH. EXAMPLE III Another woman aged 29 years was selected for further study. Hormone was obtained, purified, and modified as in Example II. This modified hormone was injected into this subject in the same way as in Example II. The subject was monitored and tested as in Example II. The results were similar to the results found in Example II except that (1) the levels of estrone and estradiol were substantially normal, (2) the subject acquired significant antibody titers late in the post-immunization cycle, and (3) in the cycle studied after six months this subject showed no significant midcycle elevation in LH patterns. EXAMPLE IV Anther woman aged 29 years was selected for further study. Hormone was obtained and purified and modified as in Example II. This modified hormone was injected into this subject in the same way as in Example II. The subject was monitored and tested as in Example II. The results were similar to the results found in Example II except that (1) baseline follicular and luteal phase LH levels were noticeably depressed in the post-treatment cycle, (2) no midcycle elevations were observed in LH, (3) estrone levels were elevated during the follicular phase of the post-immunization cycle, and (4) during the six-months study there was no significant midcycle elevation in LH patterns. EXAMPLE V Another woman aged 35 years was selected for further study. Hormone was obtained, purified, and modified as in Example II. This modified hormone was injected into this subject in the same way as in Example II. The subject was monitored and tested as in Example II. The results were similar to the results found in Example II except that (1) baseline follicular and luteal phase LH levels were noticeably depressed in the post-treatment cycle, (2) a very small midcycle elevation of LH were observed, (3) levels of FSH patterns in the post-treatment cycle were depressed, and (4) levels of both estrone and estradiol were reduced, during the follicular phase of the post-immunization. EXAMPLE VI Another woman aged 28 years was selected for further study. Hormone was obtained, purified, and modified as in Example II. This modified hormone was injected into this subject in the same way as in Example II. The subject was monitored and tested as in Example II. The results were similar to results found in Example II except that (1) baseline follicular and luteal phase LH levels were depressed in the post-treatment cycle, (2) no peaks were observed in midcycle levels of LH, (3) estrone levels appeared elevated in the follicular phase of the post immunization cycle, and (4) LH patterns indicated no significant midcycle elevation in the six-month post-immunization cycle. EXAMPLE VII Another woman aged 28 was selected for further study. Hormone was obtained, purified, and modified as in Example II. This modified hormone was injected into this subject in the same way as in Example II. The subject was monitored and tested as in Example II. The results were similar to results found in Example II except that (1) antibody titers to HCG were not detected until after three injections, (2) baseline follicular and luteal phase LH levels were depressed in the post-treatment cycle, (3) no peaks nor midcycle elevation in the LH were observed, (4) estrone levels were elevated during the follicular phase, and (5) no significant antibody titers were found in the six-month cycle. All the above examples show the practicality of injecting modified hormones for the purpose of neutralizing an endogenous reproductive hormone and thereby offering a procedure for the prevention of conception or the disruption of gestation. EXAMPLE VIII Data obtained in earlier experiments and discussed in Examples I-VII showed that a modified natural reproductive hormone, when injected into an animal of species from which it was derived, would produce antibodies that would neutralize the action of the unmodified endogenous natural hormone in the body of the animal. Hormones used in Examples I-VII were FSH, LH and HCG. New experiments were performed, baed on this knowledge, to identify another reproductive hormone (placental lactogen) that could be used in a similar fashion. Preparation of Hormone A purified preparation of placental lactogen was prepared from placentae of baboons since it was intended to use modified placental lactogen to immunize baboons. Placentae were extracted and purified on column chromatograph according to previously published procedures. The purity was tested by polyacrylamide gel, electrophoresis and by radioimmunoassay. The material obtained showed a high degree of purity on electrophoresis and radioimmunoassay showed no contamination with other placental hormones. Hormone Modification and Immunizations The baboon placental lactogen (BPL) was altered by coupling with the diazonium salt of sulfanilic acid as outlined for other hormones in Example I. The number of diazo molecules per BPL molecule in this instance was 15. Immunization procedures were also similar to those described in Example I for other hormones. Results Within 4-6 weeks after the first injection of diazo-BPL, antibody levels to natural unmodified BPL in vitro were detected in 6 female baboons. Levels rose to a plateau within 8-10 weeks and remained there for several months. Hormonal measurements indicated that there were no efects on the normal events of the menstrual cycle due to the immunizations. Since BPL is normally secreted only in pregnancy, this was not a surprising observation. All six females were mated with a male of proven fertility three times (once each in three different cycles during the fertile period). Pregnancy diagnosis by hormonal measurement was performed after each mating. From the 18 matings, there were 13 conceptions as judged by pregnancy tests. The animals that were pregnant had menstrual bleeding 7-12 days later than was expected for their normal menstrual cycles. Subsequent hormonal measurements confirmed that these 13 pregnancies were terminated by abortions approximately one week after the time of expected menses. These findings suggest that the antibodies formed in the animal's body after immunization had no effect on the nonpregnant menstrual cycle but when pregnancy was established, they neutralized the baboon placental lactogen in the baboon placenta and the result was abortion very early after conception. When in Examples I-VIII above Structures (I), (II), and (III) are modified by use of diazosulfanilic acid, dinitrophenol, or S-aceto mercaptosuccinic anhydride or Structures (II), and (III) are modified by addition of polytyrosine or polyalanine, according to known methods, the results obtained should be similar to those in said Examples. Similarly, when FSH, somatomedian, growth hormone or angiotension II are modified by use of diazosulfanilic acid or trinitrophenol, the results obtainable upon administration of the purified modified polypeptide into a male or female human or animal would indicate the stimulation of antibodies which neutralize all or some of the modified polypeptide as well as corresponding endogenous polypeptide. EXAMPLE IX The subjects used in the studies reported in the example are female baboons. All baboons were adults of reproductive age. A description of subjects and the conditions of experimentation have been described in Example I. The animals have been studied using highly purified beta subunits of HCG using a preparation with a biological activity of less than 1.0 IU/mg. Animals were immunized with 14-26 moles/mole of polypeptide of diazosulfanilic acid coupled subunits in mannide manoleate. Antibody levels were assessed by determining the binding of serum dilutions with I 125 labelled antigens. Crossreactivity of antisera was measured by direct binding of labelled antigens and by displacement radioimmunoassays. Antifertility effects in actively immunized animals were tested by mating females with males of proven fertility. Effects in pregnant baboons passively immunized with either sheep or baboon anti-β-HCG were determined by monitoring serum levels of gonadotropins and sex steroid hormones before and after immunizations. Eight female baboons were immunized with the modified beta subunit of HCG. Significant antibody levels were attained in all animals. Baboon immunizations with the modified beta subunit of HCG resulted in high antibody levels reacting to HCG, human LH and baboon CG but not to baboon LH. All animals remained ovulatory, however, no pregnancies resulted from numerous matings with males of proven fertility. Passive immunization of non-immunized pregnant baboons with sheep anti-β-HCG serum produced abortions within 36-44 hours. EXAMPLE X Hemocyanin from Keyhole limpet (KLH) solution (7 mg/ml) in 0.05 M sodium phosphate buffer in 0.2 M NaCl, pH 7.5, is prepared. Insoluble particles are removed by centrifugation. To one ml of this solution, tolylene diisocyanate (T.D.I.C.) reagent is added (20 μl) diluted to 1/30 with dioxane, the amount being essentially the equivalent of the moles of lysyl residues in the KLH molecules. After 40 minutes at 0° C., the T.D.I.C. activated KLH solution is combined with 0.5 mg of synthetic β-HCG peptide having the following structure: Asp-His-Pro-Leu-Thr-Cys-Asp-Asp-Pro-Arg-Phe-Gln-Asp-Ser-Ser-Ser-Ser-Lys-Als-Pro-Pro-Pro-Ser-Leu-Pro-Ser-Pro-Ser-Arg-Leu-Pro-Gly-Pro-Pro-Asp-Thr-Pro-Ile-Leu-Pro-Gln-Ser-Leu-Pro Structure (XV) which is first dissolved in 25 μl of 0.05 M sodium phosphate buffer in 0.2 M NaCL, pH 7.5. The mixture is incubated at 37° C. for four hours. The resulting product is purified by gel filtration. EXAMPLE XI One g. of Ficoll 70 is dissolved in 1 ml each of normal saline and 2 M ethylene diamine (adjusted to pH 10 with hydrochloric acid) solution. The solution is kept at room temperature in a water bath and stirred with a magnetic stirrer. Cyanoger bromide, 4 g, dissolved in 8 ml of dioxane, is added to the Picoll 70 solution. The acidity of the mixture is maintained at pH 10-10.5 for 8 minutes by adding drops of 2 N sodium hydroxide solution. An additional 2 ml of 2 M ethylene diamine, pH 10, solution is added, and stirring at room temperature is continued for 30 more minutes. The product is purified by passing it through a Bio-Gel p-60 column. EXAMPLE XII Two mg of the compound of Structure (II) containing picogram amount of I 125 labeled adduct and KLH (1.6 mg) is dissolved in 1 ml. of 1.0 M glycine methyl ester in 5 M guanidine hydrochloride. Ethyl dimethylamino propylcarbodiimide (E.D.C.) 19.1 mg is added to this solution. The acidity is adjusted to and maintained at pH 4.75 with 1 N HCl at room temperature for 5 hours. The KLH-peptide conjugate is purified by passing it through a Bio-Gel p-60 2.2×28 cm column equilibrated with 0.2 M NaCl. EXAMPLE XIII Solid bifunctional imidoester dihydrochloride (3 mole) is added in 2 mg portions at 5-minute intervals to a constantly stirred solution of 1 mole of polypeptide of Structure (II) (1-20 mg/ml) in 0.1 M sodium phosphate, pH 10.5, at room temperature. Sodium hydroxide 0.1 N is added to maintain the acidity at pH 10.5. One hour after the addition of the diimidoester has been completed, a polymerized product according to this invention is obtained. EXAMPLE XIV To a 20 mg/ml solution of homologous serum albumin in 0.1 M borate buffer, pH 8.5, 1000% mole excess of 25% aqueous solution of glutaric dialdehyde is added at room temperature. The excess dialdehyde is removed by gel filtration in water using Bio-Gel p-2. The material collected at the void volume is lyophilized, and the dried product is redissolved in 0.1 M borate buffer, pH 8.5 (20 mg/ml), mixed with the required amount of polypeptide of the following Structure: Asp-Asp-Pro-Arg-Phe-Gln-Asp-Ser-Ser-Ser-Ser-Lys-Als-Pro-Pro-Pro-Ser-Leu-Pro-Ser-Pro-Ser-Arg-Leu-Pro-Gly-Pro-Pro-Asp-Thr-Pro-Ile-Leu-Pro-Gln-Ser-Leu-Pro Structure (XVI) (20 mg/ml) in the same buffer at room temperature. Twenty minutes later, sodium borohydride in 250 percent molar excess of polypeptide XVI is added. The reaction is terminated after one hour. The conjugated product is purified by gel filtration on Bio-Gel p-60 column, dialyzed free of salt and lyophilized. EXAMPLE XV Ficoll 70 l g, NaHCO 3 500 mg, cyanuric chloride 3 g, H 2 O 20 ml, and dimethylformamide 80 ml., are stirred at temperature below 16° C. for 2 hours. The product is dialyzed against distilled water until Cl-free, then lyophilized. A polypeptide of Structure (XV) (2 mg) containing minute quantity of I 125 -labeled analogue is incubated with 1 mg of this product in 0.25 ml of 0.2 M sodium borate buffer, pH 9.5, for one hour at 20° C., and the product is recovered from a Bio-Gel p-60 2.2×28 cm column. When the above procedure is carried out and Dextran T 70 is used in place of Ficoll 70, the corresponding modified polypeptide, useful according to this disclosure, is obtained. EXAMPLE XVI Ficoll 70 l g, NaIO 4 1.2 g, and KCl 0.42 g are dissolved in 1.5 ml of 1 M sodium acetate buffer, pH 4.5, and incubated at 37° C. for 1 hour. Two mg (=588 μmoles) of polypeptide of Structure (XV) above mixed with a minute quantity of I 125 -labeled analogue is incubated with 2 mg of the product obtained above in 0.3 ml of 0.2 M borate buffer, pH 9.5 at 55° C. for 1 hour. The reaction mixture is then chilled in an ice water bath and NaBH 4 1 mg is then added into this solution. The reduction reaction is terminated by passing the product through a Bio-Gel p-60 2.2×28 cm column equilibrated and eluted with 0.2 M NaCl. EXAMPLE XVII Numerous rabbits are immunized with a variety of synthetic peptides conjugated to different modifying groups. Following two or three immunizations at 3-5 week intervals, sera from animals are assessed by determining their ability to bind in vitro to radiolabeled HCG. The specificity of this binding is studied by reacting the same sera against similarly labeled other protein hormones, particularly, pituitary LH. Sera are further assessed by determining their ability to inhibit the biological action of exogenously administered HCG in bioassay animals. Thus, the increase in uterine weight of the immature female rat in resonse to a prescribed dose of HCG is noted. The dose of HCG is administered subcutaneously in saline in five injections over a three day period and the animal is sacrificed for removal of the uterus on the fourth day. The weight of the uterus increases in dose reponse fashion to the hormone injections. When assessing the effects of antisera in this response, varying quantities of test serum are administered intraperitoneally separately from the subcutaneous injection of hormone during the assay. This procedure permits the antiserum to be absorbed rapidly into the rat's bloodstream and will permit interaction of it with hormone when the latter likewise enters this fluid. If the antiserum is capable of reacting with the hormone in a manner preventing stimulation of the uterus, the antiserum is considered to be effective for biological inhibition of hormone action. The frequency of animals showing a positive response to immunological binding and neutralization of biological activity is presented in EXAMPLE XVIII Iodosobenzoic acid dissolved in a slight excess of 1 N potassium hydroxide in 10% molar excess is added to the peptide of Structure (II) in phosphate buffer with normal saline at pH of 7.0. After thirty minutes at room temerature, the product polypeptide dimer is purified by gel filtration. EXAMPLE XIX To an ice water bath cooled and vigorously stirred 0.23 ml. of bovine gamma globulin (10 mg/ml) in 0.05 M phosphate buffer with normal saline (PBS) pH 7.5, 50 μl of 1/10 T.D.I.C. in dioxane is added. After 40 minutes, in excess T.D.I.C. is removed by centrifugation (0° C., 10 minutes, 10,000 g) and the precipitate is washed twice with 0.1 ml. of PBS. The combined supernatents are added to 7.7 mg. of the peptide of Structure (II) dissolved in 0.8 ml. of PBS, pH 7.5. The mixture is stirred at room temperature for 10 minutes, then incubated at 37° C. for 4 hours. The conjugate product is purified by dialysis. EXAMPLE XX BSA (10 mg/ml) in PBS solution (0.25 ml.) is treated with 50 μl of 1/10 T.D.I.C. dioxane solution and conjugated to 7.5 mg. of synthetic β-HCG peptide of Structure (III) in 0.8 ml. of PBS (pH 7.5) as in Example XIX to obtain the product. EXAMPLE XXI To an ice water bath cooled and vigorously stirred 0.6 ml. of β-HCG peptide of Structure (III) (10 mg/ml) in phosphate buffered saline, pH 7.5, is added 30 μl of 1/10 T.D.I.C. After 40 minutes, the excess T.D.I.C. is removed by centrifugation (10,000 g, 0° C., 10 minutes) and the precipitate is washed twice with 0.1 ml. PBS. The combined supernatents are added to 3 mg. of poly (D, L-Lys-Als) dissolved in 0.3 ml. of PBS. The mixture is incubated at 37° C. for 4 hours. The product is then dialyzed and lyophilized. EXAMPLE XXII The results set out in Table I provide further evidence of the broad applicability of this invention as indicated previously in this specification. Using standard methods of testing in rabbits, both immunological binding response and neutralization of biological activity were established for the medified polypeptides indicated with the result as set out in Table I. EXAMPLE XXIII Antigen was prepared by reacting a Diisocyanate (T.D.I.C.--see above) coupling reagent with carrier (tetanus toxoid), extracting excess reagent and incubating activated carrier with peptide Structure (II). Baboons were immunized with the antigen and the results of mating 4 animals three times are shown in FIG. 1. The figure shows that from 12 exposures (matings) one pregnancy resulted even though relatively low levels of immunity from the antigen were achieved. Non-immunized baboons of the same colony had a fertility rate of approximately 85%. EXAMPLE XXIV Referring to FIG. 2, baboons were immunized initially with a beta subunit of HCG modified by diazotization in a manner similar to that described in conjunction with Example II. Following this initial administration, the baboons were injected 21 and 42 days later with Structure (II) above having been modified by the same diazotization process. FIG. 2 shows plots representing the levels of antibodies generated in consequence of these administrations. Such quantities of antibodies are expressed as micrograms of isotopically-labeled HCG that will bind each milliliter of serum from the baboons at specified days after the initial injection. The levels shown were maintained for a period of over one year. TABLE 1__________________________________________________________________________Frequency of Positive Antibody Responses to Various HCGPeptide-Conjugates Number of Rabbits Immunological Neutralization ofPeptide Carrier Immunized Binding Responses Biological Activity__________________________________________________________________________35 amino acid111-145 Bovine Gamma Globulin 10 10 6Morgan et al Keyhole LimpetPeptide II Hemocyanin 10 5 *31 amino acid115-145 Poly-D-L-Alanine 10 9 5Morgan et al Bovine Serum Albumin 12 12 6Peptide III44 amino acid105-148 Keyhole Limpet Hemocyanin 10 8 *Peptide XVNatural109-145 Keyhole LimpetKeutman Hemocyanin 10 10 *Peptide XII__________________________________________________________________________ *additional time needed for assessment Referring to Table 2, the results of breeding the two baboons represented in FIG. 2 is revealed in tabular form. The table presents the results of mating these animals ten times over a period of approximately one year. These data suggest that the animals ovulated in every cycle, however, no pregnancy was observed, as indicated by the animal having a menstrual period at or before the expected time therefor. While the results tabulated demonstrate the efficacy of the entire procedure, it was observed for the particular structure utilized in the primary immunization, i.e. Structure (I), antibody cross reactivity with LH was observed. Such cross reactivity may be avoided by the utilization of the fragment conjugation procedures set forth in detail hereinabove. EXAMPLE XXV The specificity of antibody response to a CG fragmentmacromolecular carrier is represented by the instant experiment. A 35 amino acid sequence [Structure (II), herein "synthetic peptide"] of the HCG beta subunit was conjugated with bovine gamma-globulin and administered to a baboon. Varying doses of each of these three hormones were tested for their ability to compete with I 125 -labeled synthetic peptide [Structure (II)] bound to the antiserum. The results are set forth in FIG. 3. Note from the figure that Human LH was ineffective for displacement of tracer antigen at doses up to 2.5 IU (international units). Since HCG displaced antigen at a dose of 20 mIU, the cross-reactivity with HLH in this assay system was less than 0.8%. Baboon CG also displaced I 125 -labeled antigen in this assay and, based on biological potency of the two hormones, was about 20% as effective as HCG. EXAMPLE XXVI The following experiments were carried out to determine whether the carbohydrate chains contained in the C-terminal 37 residues of β-HCG influence the immunogenicity of that peptide. TABLE 2______________________________________Breeding of Immunized Baboons[Diazo-β-HCG presensitized]Booster: Diazo-β-hCG-(111-145)1 2Pre-Mate Pre-MateTiter Ovul. Preg. Titer Ovul. Preg.______________________________________Mating No. 15.00 + - 4.20 + -Mating No. 24.25 + - 4.10 + -Mating No. 34.22 + - 4.00 + -Mating No. 44.17 + - 3.89 + -Mating No. 53.80 + - 3.76 + -Mating No. 66.65 + - 5.00 + -Mating No. 75.90 + - 4.75 + -Mating No. 85.10 + - 4.20 + -Mating No. 95.00 + - 4.25 + - Mating No. 104.66 + - 4.00 + -______________________________________ A peptide representing amino acid residues 109-145 of β-HCG was isolated from a chymotryptic digest of reduced and carboxymethylated β-HCG by procedures reported by Keutmann, H. T.; Williams, R. M., J. Biol. Chem. 252, 5393-5397 (1977). This peptide is identified in Table 3 as P-1. The purity of the peptide was confirmed by amino acid and terminal end group analyses. A portion of the isolated peptide was treated with anhydrous hydrofluoric acid (HF) to remove carbohydrate moieties and repurified by column chromatography according to methods described by Sakakibara S. et al, Bull. Chem. Soc. Japan, 40, 2164-2167 (1967). This portion of the isolated peptide is identified in Table 3 as P-2. Complete removal of the sugar chains were confirmed by carbohydrate analysis; See Nelson, Norton, J. Biol. Chem. 153, 375-380 (1944). A third peptide with the amino acid sequence 109-145 of β-HCG was prepared synthetically using the solid state synthesis procedure of Tregear, G. W. et al., Biochem. 16, 2817 (1977). This third peptide is identified in Table 3 as P-3. Highly purified HCG was used in all immunological experiments where reference was made to intact HCG. Preparation of Immunogens and Immunizations Conjugates of the three peptides were prepared to keyhole-limpet hemocyanin (KLH) using tolulene diisocyanate. A peptide-carrier ratio of 4-6 peptides per 100,000 daltons of carrier was obtained for different conjugates prepared according to amino acid analyses. Rabbits were immunized with conjugates by three multiple site intramuscular injections of 1.0 mg. of conjugate in 0.5 ml. of saline emulsified with an equal volume of Freund's complete adjuvant. Injections were given at 3 weeks intervals and weekly blood samples were collected from 3-20 weeks of immunization. Evaluation of Antisera Antisera to all conjugates were monitored for antibody levels by reacting dilutions of sera with I 125 labeled HCG (chloramine T method) at 4° C. for 5 days and precipitating immune complexes with sheep anti-rabbit gamma globulin serum. Antibody levels were determined by assessing dilution curves in which a linear correlation between dilution and binding of labelled antigen at equilibrium occurred. At least 3 points in each curve were used in calculating levels. These levels were expressed as μg. HCG bound per ml. of undiluted serum calculated by multiplying mass of labelled antigen bound by serum dilution. A radioimmunoassay system employing I 125 HCG and antisera raised to peptide conjugates was used to determine the relative ability of HCG and peptides to compete with labeled HCG. Peak antibody levels from each rabbit were evaluated in these studies. Antigens and antisera contained in phosphate-buffered saline (pH 7.4) BSA (1%) were added to test tubes and incubated at 4° for 5 days. Separation of free and bound tracer HCG was accomplished by the addition of sheep anti-rabbit gamma globulin serum and further incubated for 48 hours followed by centrifugation. Assessment of parallelism of dose response curves was accomplished using methods described by Rodbard, D. in: Odell, W. D. and Daughaday, W. H., eds., "Competitive Protein Binding Assays," J. B. Lippincott, Phila. Pa. (1971). The ability of unlabelled HCG and peptides to compete with I 125 HCG for antibody binding sites was expressed as moles of unlabeled antigen, per mole of unlabeled HCG, required to reduce the binding of labeled HCG by 50%. For this purpose molecular weights for HCG, P-1, P-2, and P-3 of 38,000, 7,000, 3,990, and 3,990 respectively were used. The molecular weight of the P-1 peptide was an estimate since the contribution of the 4 carbohydrate chains to its size was not determined. Four radioimmunoassays were performed with each of the 11 antisera studied and the results presented as the mean of the four values. RESULTS Parallel dose response curves of HCG and peptides were observed in all radioimmunoassays. In the assay system employed, 200-400 moles of unlabeled HCG was required per mole of labeled HCG at 50% binding of the latter to antisera. There was no detectable difference among antisera to the 3 peptide conjugates in the ability of intact HCG to compete with labeled hormone for antibody binding sites. Data obtained from comparing the ability of HCG and peptides to compete with I 125 HCG for binding to anti-peptide sera revealed some qualitative differences in the antisera (Table 2). Much larger quantities of P-2 peptide and P-3 peptide were required to reduce I 125 HCG binding than was required by P-1 peptide when sera against the P-1 peptide was tested. While similar quantities of P-2 and P-3 peptides were required to inhibit one mole of labeled HCG binding, these were 2-10 times the amounts required by the P-1 peptide. Differences in the quantities of peptides required to compete with an equivalent mass of labeled HCG were less using antisera raised to carbohydrate-free natural peptide (P-2). More P-1 peptide was needed for an equal reduction in binding than the other 2 peptides. No significant difference could be detected in the quantities of P-2 or P-3 peptides required among the 3 antisera tested. Approximately 1.5-2.0 times as much P-1 peptide was required to compete equally with I 125 HCG for antibodies raised to the P-3 peptide but P-2 peptide reacted nearly as well as did the synthetic peptide. DISCUSSION Despite low levels of antibodies obtained in this study, the carbohydrate-containing peptide was not more immunogenic than those without this moiety when conjugates to both were prepared in the same manner TABLE 3______________________________________Mean Quantities of HCG and 109-145 C-Terminal β-HCGPeptides Required to Compete with I.sup.125 HCG at 50%Binding of Labelled HormoneUnlabelled Antigens HCG P-1 P-2 P-3Antisera mol/mol mol/mol mol/mol mol/molRabbit HCG I.sup.125 HCG I.sup.125 HCG I.sup.125 HCG I.sup.125No. (X ± SE) (X ± SE) (X ± SE) (X ± SE)______________________________________Anti P-1 78 284 (12.6) 430 (11.8) 4565 (200.8) 3628 (154.1) 79 350 (13.5) 404 (18.5) 855 (33.4) 881 (42.2)171 403 (17.7) 343 (9.9) 899 (35.1) 759 (37.1)173 377 (16.5) 320 (13.9) 1448 (72.4) 1536 (73.7)Anti P-2 93 247 (11.8) 385 (18.2) 264 (12.5) 268 (12.73) 94 294 (14.1) 431 (15.5) 362 (15.2) 329 (13.8)252 201 (9.6) 296 (12.4) 216 (7.7) 205 (9.0)Anti P-3405 496 (23.6) 998 (47.4) 628 (27.6) 309 (13.6)411 489 (20.5) 1200 (50.4) 678 (29.7) 413 (16.1)416 364 (13.1) 581 (20.9) 400 (14.4) 271 (12.8)417 340 (14.9) 474 (18.4) 176 (6.8) 105 (4.6)______________________________________ From these studies, it can be concluded that although antibodies to carbohydrate free peptides are qualitatively different than those to the natural peptide, antisera generated to the synthetic peptide reacted with HCG as well as antisera to natural peptides and equivalent to natural and synthetic peptides elicited similar anti-HCG levels in rabbits. EXAMPLE XXVII In this Example, a polypeptide fragment structure having an --SH group is activated utilizing the following reagent: ##STR9## A solution of the reagent (1.2 eq. per --SH group in the polypeptide) in a suitable water miscible organic solvent, such as dioxane, is added to a solution of the polypeptide fragment structure, e.g. Structure (XII) (which has had its amino groups blocked) in aqueous buffer at pH 6.5. After 2 hours, the solvent is removed at a temperature of less than 30° C. under vacuum, and to the residue are added water and ethyl ether (1:1). The aqueous layer is separated and its pH adjusted to approximately 8.5 by the addition of sodium hydroxide solution and this alkaline mixture is added rapidly to an aqueous solution of the carrier, e.g. the above described influenza subunit, maintained at pH 8.5 by a suitable buffer. After a further 4 hours, the conjugate is isolated, by gel filtration. EXAMPLE XXVIII With the following reagent: ##STR10## a solution or suspension of a carrier containing no sulfhydryl groups such as Flagellin in a suitable aqueous buffer at a pH 6.5 is treated with the required (1.2 eq/-NH 2 desired to be reacted) amount of a solution of the reagent in dimethylformamide. After 1 hour, the modified carrier is isolated by column chromatography and added to buffer at pH 6-7. This is then treated with a solution of the selected fragment (containing sulfhydryl groups) in the same buffer and the reaction is allowed to proceed for 12 hours before the conjugate is isolated by column chromatography. EXAMPLE XXIX Modification of non-sulfhydryl containing peptide fragments [e.g. Structure (II)] or a carrier such as Flagellin to a sulfhydryl containing one via "thiolactonization" is carried out as follows: The peptide is dissolved in a 1 M aqueous solution of imidazole containing 0.5% of ethylenediamine tetraacetic acid at a pH of 9.3 under an atmosphere of nitrogen and a 100 fold excess of N-acetylhomocysteine thiolactone is added in three portions at eight hour intervals. After a total of 30 hours, the pH is adjusted to 3-4 with acetic acid and the modified peptide is isolated by gel chromatography and elution with 0.5 M acetic acid. EXAMPLE XXX The carrier protein is reacted with the N-hydroxysuccinimide ester of a halo-(either chloro, bromo or iodo) acetic acid in the general procedure described in the first part of Example XXVIII thus yielding a modified carrier containing the required number of halomethyl alkylating groups as desired. To a solution of the sulfhydryl containing peptide [e.g. Structure (XII)] in a phosphate buffer at pH 6.5-7.0 under nitrogen at room temperature is added an aqueous solution or suspension of the modified carrier prepared above. The mixture is stirred for 12 hours. It is then washed with ethyl acetate and the conjugate contained in the aqueous phase is purified by dialysis, gel chromatography and lyophilization. Should neither the carrier nor polypeptide fragment contain a sulfhydryl group, one may be introduced into either of them by the standard procedures such as "thiolactonization" described above under Example XXIX.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates generally to soil openers that use a disc assembly to open the soil prior to injection of a fertilizer or seed into the ground. More specifically, the present invention concerns a sectored disc assembly for use in such a soil opener, a removable disc sector of a sectored disc assembly, as well as a method of replacing a disc sector of a sectored disc assembly. 2. Discussion of the Prior Art Those of ordinary skill in the art will appreciate that farmers often use no-till planting techniques to produce all types of agricultural crops. Such no-till techniques minimize the disturbance to the soil and leaves the stubble, or organic matter from the previous crop, standing in the field. This, in turn, reduces water runoff in the field, thereby greatly reducing erosion of the top soil. Typically, no-till planting involves using a rotatable disc soil opener to cut a furrow in the soil as it is pulled across a field, creating a small disturbed soil zone. Fertilizer, seeds, or both, are then injected into this disturbed soil zone, after which the furrow is closed. The closing of the furrow can be accomplished by naturally allowing the disturbed soil to flow back into the furrow, or by following the rotatable disc soil opener with a closing wheel designed to push soil into the disturbed soil zone and close the furrow. Often, the opening of the furrow, formation of the seed bed, injection of fertilizer, seed, or both, and closing of the furrow are accomplished in a single pass with a soil opener that includes a rotatable disc, an injector foot, and a closing wheel. Conventional rotatable discs used in soil openers have been formed, most typically out of carbon steel, as single, annular bodies for rotation about a spindle on the soil opener. While this unitary construction has been satisfactory in some respects, such solid discs are very heavy components that can be difficult to handle and are often expensive to produce. As the rotatable disc component of a soil opener directly contacts the soil as the implement moves through a field, the disc is subject to considerable stress and is exposed to damage. Damage to a rotatable disc, often the result of transport, inexperienced or poor operators, or hitting a railroad track or rocks in the soil, requires replacement of the entire disc. Such disc replacement is expensive and time consuming, as the entire heavy disc must be removed from the soil opener, typically involving tedious disassembly of the entire supporting frame, and only then can an entire new disc be installed. The cost associated with whole disc replacement can be disproportional to the amount of damage to the disc, such as when a single portion of the edge of the disc is damaged from hitting a rock. Additionally, the replacement of the whole disc results in considerable down time of the implement, as heavy components must be elevated out of the soil to facilitate removal of the disc to be replaced and installation of a new disc. The time requirement associated with such replacement adds to the cost and inconvenience of the periodic and necessary change out of rotatable discs. SUMMARY The present invention provides a unique sectored disc assembly, removable disc sector, and method of replacing a disc sector for use with a soil opener that uses a disc assembly to open the soil prior to injection of a fertilizer or seed into the ground. The sectored disc includes multiple disc sectors that can be removed and replaced individually, requiring a fraction of the cost and time of whole disc replacement. The quick and simple change out of disc sectors also allows an operator to match the disc material to the soil type for improved performance of the soil opener. According to one aspect of the present invention, a sectored disc assembly for use in a soil opener of an agricultural implement is provided, wherein the disc assembly serves as a blade to open the soil prior to injection of a fertilizer or seed into the ground. The sectored disc assembly includes a rotatable hub, wherein the hub presents a central rotational axis and a radial outer periphery. The sectored disc assembly also includes a plurality of disc sectors, wherein each disc sector is disposed around the periphery of the hub and extends radially outwardly therefrom. The disc sectors cooperatively form a substantially continuous disc disposed radially around and coaxial with the hub. The disc sectors cooperate with the hub to define a substantially continuous interface therebetween around the periphery of the hub. Each disc sector cooperates with the hub to present a tongue-and-groove connection along the interface, wherein one of the disc sector and hub includes a radially extending internal groove and the other of the disc sector and hub includes a radially extending tongue, with the tongue being snugly received in the groove to restrict axial movement of the disc sector relative to the hub. Another aspect of the present invention concerns a disc sector that is removably and individually connectable to a rotatable hub of a sectored disc assembly serving as a blade of a soil opener to open the soil prior to injection of a fertilizer or seed into the ground, wherein the hub presents a central rotational axis and a pair of circumferentially extending opposed faces along the outer periphery thereof, and wherein the disc sector cooperates with other disc sectors to form a substantially continuous disc disposed radially around the hub. The disc sector includes a sector body that presents a radially inner margin, a radially outwardly spaced generally arcuate outer margin, and generally radially extending side margins each defined between the inner and outer margins. The body includes a pair of opposed engagement surfaces configured for flush contact with the opposed faces of the hub so that axial movement of the disc sector relative to the hub is thereby restricted. The body presents an axial thickness that tapers in a radially outer direction adjacent the outer margin. The side margins cooperatively form an acute angle therebetween and are configured for continuous abutment with adjacent ones of the other disc sectors. Yet another aspect of the present invention concerns a method of replacing a disc sector of a sectored disc assembly serving as a blade of a soil opener to open the soil prior to injection of a fertilizer or seed into the ground. The method includes the steps of removing the connector that secures the disc sector to the rotatable hub of the sectored disc assembly, moving the disc sector radially outwardly and away from the hub, placing a replacement disc sector into contact with the hub so that the replacement disc sector and hub cooperatively form a tongue-and-groove connection extending along the periphery of the hub, and inserting the connector to secure the replacement disc sector to the hub. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description of the preferred embodiments. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. Various other aspects and advantages of the present invention will be apparent from the following detailed description of the preferred embodiments and the accompanying drawing figures. BRIEF DESCRIPTION OF THE DRAWING FIGURES A preferred embodiment of the present invention is described in detail below with reference to the attached drawing figures, wherein: FIG. 1 is a side elevational view of a portion of a towable agricultural implement with a soil opener including a rotatable sectored disc assembly constructed in accordance with the principles of a preferred embodiment of the present invention; FIG. 2 is an enlarged, fragmentary top-down plan view of a portion of the soil opener shown in FIG. 1 , with an optional closing wheel shown in phantom lines, particularly illustrating the coupling of the soil opener to the toolbar and the rotatable sectored disc assembly; FIG. 3 is a fragmentary top-down plan view on a reduced scale of a towable agricultural implement having a toolbar and a plurality of soil openers including rotatable sectored disc assemblies constructed in accordance with the principles of a preferred embodiment of the present invention; FIG. 4 is an enlarged, side elevational view of the soil opener shown in FIG. 2 , presented from the opposite vantage point of that in FIG. 1 , with the optional closing wheel shown in solid lines, particularly illustrating the rotatable sectored disc assembly coupled to a draw bar assembly and an adjacently disposed injector foot; FIG. 5 is a an enlarged, side elevational view of the soil opener shown in FIG. 4 , presented from the opposite vantage point, with the optional closing wheel shown in phantom lines, particularly illustrating the rotatable sectored disc assembly coupled to the draw bar assembly and the adjacently disposed injector foot; FIG. 6 is an enlarged, top-down sectional view of the rotatable sectored disc assembly and associated portion of the draw bar assembly, the view taken along the line 6 - 6 of FIG. 5 , particularly illustrating in detail a plurality of disc sectors disposed about a rotatable hub with a tongue-and-groove connection and secured thereto with connecting bolts; FIG. 7 is an exploded perspective view of the sectored disc assembly shown in FIG. 6 , particularly illustrating the separate components thereof, including the rotatable hub, the plurality of disc sectors, and the connecting bolts; and FIG. 8 is a perspective assembly view of the sectored disc assembly shown in FIG. 7 , particularly illustrating the plurality of disc sectors cooperatively forming a substantially continuous disc disposed about the rotatable hub, with one disc sector shown in phantom lines to depict removal of a single disc sector from the sectored disc assembly and the associated disposition of the connecting bolt through a portion of the rotatable hub. The drawing figures do not limit the present invention to the specific embodiments disclosed and described herein. The drawings are not necessarily to scale, emphasis instead being placed upon clearly illustrating the principles of the preferred embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention is susceptible of embodiment in many different forms. While the drawings illustrate, and the specification describes, certain preferred embodiments of the invention, it is to be understood that such disclosure is by way of example only. There is no intent to limit the principles of the present invention to the particular disclosed embodiments. With initial reference to FIG. 1 , a towable agricultural implement 10 selected for purposes of illustration includes a floating hitch section 12 and a framework 14 . The floating hitch section 12 includes a hitch connector 16 at a terminal end thereof. It will be appreciated by one of ordinary skill in the art that the hitch connector 16 is configured for coupling the implement 10 to a corresponding towing hitch on a driving power source (not shown) for pulling the implement 10 across a field. It is also noted that such a driving power source could take the form of a tractor, or any other suitable power source known in the art, without departing from the teachings of the present invention. The framework 14 is supported above the ground 18 by wheels 20 , rotatably connected to the framework 14 by bolts 22 , in a manner known in the art and not shown in detail here. With reference to FIG. 3 , the implement 10 is pulled through a field in the direction indicated by the large arrow. Thus, the wheels 20 support the rear portion of the framework 14 . The front portion of the framework 14 is supported by the connection of the floating hitch section 12 to a driving power source and an additional section 15 of the framework 14 is supported in the front by a supplemental swiveling support wheel 24 . As shown in FIG. 1 , the swiveling support wheel 24 is journaled to a wheel arm 44 for rotation therebetween. The wheel arm 44 is pivotally coupled to a forward extension 46 in a manner known in the art and not shown in detail here. The forward extension 46 brackets to the toolbar 28 to space the swiveling support wheel 24 ahead of the toolbar 28 as the implement 10 moves across a field. It is noted that the swiveling support wheel 24 is disposed on the section 15 of the framework 14 that is not otherwise supported in the front by the connection of the floating hitch section 12 to a driving power source. Additionally, this section 15 of the framework 14 may pivot upwards relative to the central section of the framework 15 to facilitate transport of the implement 10 across the ground other than in a field, as will be readily appreciated by one of ordinary skill in the art. It is noted, however, that such arrangement of the framework 14 is not critical to the principals of the present invention. Returning now to FIG. 1 , the framework 14 also includes a vertically extending support member 26 , extending downwardly from the framework 14 . The support member 26 connects the framework 14 to a toolbar 28 , through a spacing element 30 , in a manner known in the art. As shown particularly in FIG. 3 , the toolbar 28 extends transverse to the direction of travel of the implement 10 . A plurality of soil opener assemblies 32 are coupled to the toolbar 28 , as described in more detail below. It is noted that FIG. 3 depicts a plurality of soil opener assemblies 32 linearly coupled to the toolbar 28 in a single gang. However, it will be appreciated that the layout of the plurality of soil opener assemblies 32 could take other forms, such as a two gang configuration, or be variously configured in any manner known in the art, including any alternative suitable number or spacing of soil opener assemblies 32 . It is further noted that each soil opener assembly 32 is virtually identically configured to each other soil opener assembly 32 . Thus, in each of the drawing figures other than FIG. 3 , only a single soil opener assembly 32 is depicted, with the understanding that other soil opener assemblies 32 are similarly constructed. With continued reference to FIG. 1 , the exemplary soil opener assembly 32 depicted broadly includes a drawbar assembly 36 , a sectored disc assembly 38 , an injector boot assembly 40 , and a closing wheel 42 . The drawbar assembly 36 is bracketed to the toolbar 28 to thereby pull the other components of the soil opener assembly 32 behind the toolbar 28 while yieldably biasing the components downwardly into engagement with the ground 18 as the implement 10 moves through a field. With particular reference to FIGS. 2 and 5 , a swiveling assembly 48 is attached to the toolbar 28 with a plurality of bolts 50 . The swiveling assembly includes an inner member 52 and a coaxial outer member 54 that are configured for relative rotation therebetween. A mounting bracket 56 extends outwardly from the outer member 54 . The bolts 50 pass through a plate 58 , around the toolbar 28 , and are secured to the mounting bracket 56 to thereby clamp the swiveling assembly 48 to the toolbar 28 . A drawbar bracket 60 connects the drawbar assembly 36 to the inner member 52 so that the drawbar assembly 36 can swivel relative to the toolbar 28 . A locking pin 62 selectively locks the inner member 52 and the outer member 54 together to prevent relative rotation therebetween, thereby permitting an operator to “lock out” the swiveling movement of the drawbar assembly 36 . Such locking out of the swiveling assembly 48 is often used, for example, to prevent drift of the soil opener assemblies 32 as the implement 10 is towed along steep inclines, as will be readily appreciated by one of ordinary skill in the art upon review of this disclosure. Turning now to FIGS. 4 and 5 , the drawbar assembly 36 includes a disc opener arm 64 pivotally coupled to the drawbar bracket 60 with a pin 66 . The pivotal movement of the drawbar assembly 36 allows the components thereof to be vertically adjusted relative to the ground 18 . The vertical position of the drawbar assembly 36 is controlled by an adjustable-length strut 68 . The strut 68 includes an outer cylinder 70 and a telescopingly interfitted inner rod 72 , wherein the inner rod 72 is coaxial with and configured for relative sliding within the outer cylinder 70 . A strut pin 74 passes through the outer cylinder 70 and into at least a portion of the inner rod 72 in a manner known in the art to lock the strut 68 at a particular length. A strut support 76 is fixed to and extends vertically upwardly from the drawbar bracket 60 . The ends of the adjustable-length strut 68 extends between a fixed position on the strut support 76 and a fixed position on the disc opener arm 64 . In the illustrated embodiment, an end of the outer cylinder 70 is coupled to the top of the strut support 76 with a bolt-and-nut assembly 78 in a manner known in the art. Similarly, an end of the inner rod 72 is coupled to the disc opener arm 64 with a bolt-and-nut assembly 80 in a manner known in the art. It is noted that the depicted orientation of the strut 68 could be reversed, or an alternative device for adjusting the vertical height of the drawbar assembly 36 relative to the ground 18 could be used, without departing from the teachings of the present invention. The sectored disc assembly 38 is rotatably coupled with and vertically fixed to the disc opener arm 64 , as is discussed in greater detail below, for relative rotation therewith. Thus, it is noted that as the drawbar assembly 36 , including the disc opener arm 64 , is vertically adjusted relative to the ground 18 as described above, the sectored disc assembly 38 is correspondingly vertically adjusted relative to the ground 18 . It is further noted that the principles of the present invention are not limited to the production of any particular crop and can readily be adapted to virtually all crops generated by placement of seed and/or fertilizer in the ground, as will be understood by one of ordinary skill in the art. A closing wheel arm 82 is adjustably mounted to the disc opener arm 64 , wherein the closing wheel arm 82 rotatably supports the closing wheel 42 at the end thereof. The closing wheel arm 82 is fixed to a closing wheel arm mounting bracket 84 that attaches to the disc opener arm 64 with a pair of bolt-and-nut assemblies 86 . The bolt-and-nut assemblies 86 attach the mounting bracket 84 to the disc opener arm 64 by extending through a selected pair of a plurality of holes 88 in the disc opener arm 64 . Extending the bolt-and-nut assemblies 86 through distinct pairs of holes 88 allows the closing wheel arm 82 to be adjustably mounted to the disc opener arm 64 . By extension, this relative adjustability affects the relative position of the components mounted to the end of each of these arms, namely the sectored disc assembly 38 and the closing wheel 42 , respectively. As shown in the difference between FIGS. 4 and 5 , it is noted that the closing wheel 42 , and its associated closing wheel arm 82 , are depicted in FIG. 4 by way of example only and that the principals of the present invention do not depend on the selective inclusion of these elements, as will be readily appreciated by one of ordinary skill in the art upon review of this disclosure. With continued reference to FIG. 5 , an injector boot support element 90 is fixed to the end of the disc opener arm 64 with a pair of bolt-and-nut assemblies 92 . The bolt-and-nut assemblies 92 attach the boot support element 90 to the disc opener arm 64 by extending through a selected pair of a plurality of holes 94 in the disc opener arm 64 . Extending the bolt-and-nut assemblies 92 through distinct pairs of holes 94 allows the boot support element 90 to be adjustably mounted to the disc opener arm 64 . The injector boot assembly 40 is fixed to the distal end of the boot support element 90 relative to the disc opener arm 64 by a bolt-and-nut assembly 96 . Thus, adjustment of the boot support element 90 relative to the disc opener arm 64 as described above changes the disposition of the injector boot assembly 40 relative to the sectored disc assembly 38 . The injector boot assembly 40 broadly includes a pair of conduits 98 and 100 for carrying and controllably inserting seed, fertilizer, or both, into the ground in a manner generally known in the art and not described in detail here. Additionally, as shown in FIG. 6 , a threaded extension 102 controls the lateral disposition of a distribution end 104 of the injector boot assembly 40 relative to the sectored disc assembly 38 . The threaded extension 102 is coupled to the boot support element 90 and secured thereto with a nut 106 . In the depicted embodiment, the distribution end 104 of the injector boot assembly 40 is adjacent an end of the sectored disc assembly 38 , although this placement could be changed without departing from the teachings of the present invention. As discussed briefly above, the sectored disc assembly 38 is rotatably coupled to the disc opener arm 64 for relative rotation therewith. The sectored disc assembly 38 broadly includes a rotatable hub 108 and a plurality of disc sectors 110 disposed around the hub 108 to cooperatively form a substantially continuous disc 111 . In the illustrated embodiment, the hub 108 has considerable mass, weighing slightly more than one hundred pounds, substantially contributing to the total weight of each soil opener assembly 32 of approximately five hundred pounds. The disc sectors 110 cooperate with the hub 108 to present a tongue-and-groove connection therebetween along the interface between the disc sectors 110 and the hub 108 . As will be readily appreciated by one of ordinary skill in the art, as the agricultural implement 10 moves across a field, the soil opener assemblies 32 are often disposed at a slight angular offset relative to the direction of travel of the implement 10 . It is particularly noted that while FIG. 3 depicts the soil opener assemblies 32 generally aligned with the direction of travel, the soil opener assemblies 32 may move about the swiveling assembly 48 during operation and often do not precisely follow the direction of travel. It is additionally noted that sometimes the soil opener assemblies 32 are intentionally offset from the direction of travel to facilitate the opening of the soil. This angular offset can lead to the introduction of considerable lateral forces to the components of the soil opener assemblies 32 , including the substantially continuous disc 111 . The tongue-and-groove connection between the disc sectors 110 and the hub 108 of the unique sectored disc assembly 38 described herein directs these lateral forces inward to the central hub 108 such that axial movement of the disc sectors 110 is restricted. As shown particularly in FIG. 6 , a spindle 112 is fixed to the disc opener arm 64 with a pair of bolts 114 , wherein the spindle 112 extends generally transverse to the direction of travel of the implement 10 across a field. The hub 108 includes a generally central hole 116 therethrough about which the hub 108 is disposed about the spindle 112 for relative rotation therewith in a manner generally known in the art. A cap 118 is attached to the hub 108 with a plurality of screws 120 to cover the hole 116 when the hub 108 is disposed on the spindle 112 . The cap 118 prevents dirt or other debris from entering the hole 116 in the hub 108 , as will be appreciated by one of ordinary skill in the art. With continued reference to FIG. 6 and turning also to FIGS. 7 and 8 , the component parts of the sectored disc assembly 38 will be discussed in greater detail. The hub 108 is generally circular and presents a continuous outer periphery 122 , although it is noted that it is within the ambit of the present invention to incorporate alternative hubs of other general shapes (e.g., polygonal), so long as such a hub is rotatable about the spindle 112 or the like. The hub 108 also includes a radially inwardly extending circumferential groove 124 that extends continuously about the outer periphery of the hub 108 . In the illustrated embodiment, the hub 108 includes an additional groove 126 , substantially identical to the groove 124 , but disposed axially away from the groove 124 . The second groove 126 can provide an alternative location for the disposition of the plurality of disc sectors 110 . The second groove 126 can also provide a location for the disposition of a depth band for controlling the depth to which the soil is opened, as will be appreciated by one of ordinary skill in the art. Although it is not necessary to provide multiple grooves in the hub 108 , it is further noted that more than the two depicted grooves could be provided in the hub 108 , so long as there is at least one groove to cooperate with the plurality of disc sectors 110 to form the substantially continuous disc 111 of the sectored disc assembly 38 . It is further noted that an alternative hub (not shown) could present a noncontinuous groove without departing from the teachings of the present invention, as will be readily appreciated by one of ordinary skill in the art upon review of this disclosure. The plurality of disc sectors 110 , depicted individually in detail in FIG. 7 , each includes a radially inner margin 128 and a radially outer margin 130 . Each disc sector 110 further includes radially extending side surfaces 132 and 134 that extend generally flatly between the inner margin 128 and the outer margin 130 . The disc sectors 110 are each partially received within the groove 124 to restrict axial movement of each disc sector 110 relative to the hub 108 . The disc sectors 110 and the hub 108 interfit in a tongue-and-groove connection along the outer periphery 122 of the hub 108 to form the substantially continuous disc 111 about the hub 108 , as will be described in more detail below. The radially outer margins 130 of the plurality of disc sectors 110 are generally arcuate and cooperate to form a substantially continuous disc edge 136 . The disc edge 136 is generally circular and serves as the end of a blade to open the soil as the implement 10 moves across a field, as will be readily appreciated by one of ordinary skill in the art. It is noted that it is clearly within the ambit of the present invention to provide alternative disc sectors that cooperate to form a disc edge that is noncontinuous and presents, for example, an edge that is fluted, serrated, or spoked. The axial width of the disc sectors 110 taper inwardly from the radially inner margins 128 to the radial outer margins 130 such that the tongue-and-groove connection is sufficiently strong to take the lateral forces and the disc edge 136 is sufficiently narrow to penetrate into the soil to form the furrow. In the illustrated embodiment, the radially inner margins 128 of the disc sectors 110 are also generally arcuate and correspond with the shape of the groove 124 in the hub 108 to interfit therein. It is noted, however, that with an alternately shaped hub, such as described above, it is clearly within the ambit of the present invention for the corresponding radially inner margins of cooperating alternative disc sectors to have a shape that is nonarcuate to flushly engage a corresponding surface on the outer periphery of such an alternative hub. With continued reference to the embodiment depicted in FIGS. 7 and 8 , it is noted that the illustrated groove 124 of the hub 108 presents a generally U-shaped channel with opposed faces 138 and 140 . Similarly, the groove 126 of the hub 108 presents a generally U-shaped channel with opposed faces 142 and 144 . Also in the illustrated embodiment, the each disc sector 110 includes a tongue section 146 that presents opposed engagement surfaces 148 and 150 . In the tongue-and-groove connection between the disc sectors 110 and the hub 108 , the opposed faces 138 and 140 of the groove flushly contact the engagement surfaces 148 and 150 of the tongue section 146 . It is clearly within the ambit of the present invention to provide an alternative groove that is not U-shaped, so long as the tongue and groove sections correspond for a snug connection therebetween. It is additionally specifically noted that in an alternative embodiment (not shown) that the components of the tongue-and-groove connection could be switched, such that a central hub presents a tongue section and a plurality of disc sectors present a corresponding groove. In such an alternative embodiment, similar flush contact would result between opposed faces and engagement surfaces such that a substantially continuous disc would be formed about the hub, wherein axial movement of the disc sectors relative to the hub was restricted. Regarding additional specifics of the depicted central hub 108 , it is noted that the hub 108 includes a pair of axially opposed, generally planar side portions 152 and 154 . The grooves 124 and 126 in the central hub 108 define radially extending flange sections 156 , 158 , and 160 along the outer periphery 122 of the hub 108 , wherein the grooves 124 and 126 extend between the flange sections 156 , 158 , and 160 . The flange section 156 extends axially between the hub side portion 152 and the opposed face 138 of the groove 124 . Similarly, the flange section 158 extends axially between the opposed face 140 of the groove 124 and the opposed face 142 of the second groove 126 . Also, the flange section 160 extends axially between the opposed face 144 of the second groove 126 and the hub side portion 154 . Regarding additional specifics of the depicted individual disc sectors 110 , it is noted that each disc sector includes a pair of axially extending flared shoulder sections 162 that each extend axially outward beyond the dimension of the tongue section 146 . Each of the shoulder sections 162 present a radially inner shoulder surface 164 . In the sectored disc assembly 38 , the shoulder surfaces 164 flushly contact the outer periphery 122 of the hub 110 . As described briefly above, the radially extending side surfaces 132 and 134 of each disc sector 110 extend generally flatly between the inner margin 128 and the outer margin 130 . A surface 132 of an individual disc sector 110 bears against the corresponding surface 134 of an adjacent disc sector 110 to restrict circumferential movement of any individual disc sector 110 of the substantially continuous disc 111 . In addition, as shown in FIG. 8 , the generally flat shape of the side surfaces 132 and 134 allow a single disc sector 110 to be removed from or inserted into the hub 108 without disturbance to the other disc sectors 110 . With continued reference to the embodiment depicted in FIGS. 7 and 8 , a plurality of bolt connectors 166 are included to secure each of the disc sectors 110 to the central hub 108 . The hub 108 includes a plurality of holes 168 that extend axially therethrough, spanning all of the flange sections 156 , 158 , and 160 . Each of the disc sectors 110 similarly includes a hole 170 that is axially aligned with the corresponding hole 168 in the hub 108 when the disc sector 110 is disposed therein. A bolt 166 extends through a washer 172 , through one of the holes 168 in the flange section 156 , through one of the holes 170 in the disc section 110 , and through the remainder of the hole 168 in the hub 108 . Each of the disc sectors 110 are secured to the hub 108 in like manner, as will be readily appreciated by one of ordinary skill in the art. The front side 152 of the hub 108 also includes a recess 174 around each of the holes 168 . The recess 174 is axially larger than the diameter of the hole 168 and extends radially inwardly through the flange 156 toward the groove 124 . Each of these recesses 174 allow the head of the bolt 166 to countersink below the surface of the front side 152 of the hub 108 as shown in FIG. 8 . The countersinking of the bolts 166 into the hub 108 provides the sectored disc assembly 38 with a clean design without exposed hub nuts or bolts to disturb material as the blade cuts into the soil. Finally, it is noted that in the illustrated embodiment, the sectored disc assembly 38 includes four substantially identical disc sectors 110 that each define a quadrant of the substantially continuous disc 111 . It is clearly within the ambit of the present invention to provide alternative disc sectors that are not substantially identical or require more or fewer than the depicted four sectors to make up a substantially continuous disc. Such variations will be readily appreciated by one of ordinary skill in the art upon review of this disclosure. The disc sectors 110 are preferably, although not necessarily, formed by casting the sectors from a metal alloy. Examples of preferred alloys for the material of the disc sectors 110 include steel 8630, ASTM 897 heat treated, and YC chrome, as will be understood by one or ordinary skill in the art. The efficient and simple ability to change out individual disc sectors 110 allows an operator to replace damaged or worn disc sectors 110 without the cost of replacing an entire unitary disc. In addition, an operator can easily change the material of the disc sectors 110 , and thus the entire disc 111 , as desired to match the material of the disc to the particular characteristics of the soil to be worked by the implement 10 . The method of replacing a given disc sector 110 of the sectored disc assembly 38 should be apparent from the foregoing and, therefore, will be described here only briefly. With particular reference to FIGS. 7 and 8 , the connecting bolt 166 is accessed through the recess 174 and removed from the sectored disc assembly 38 in the axial direction. After the removal of this single connecting bolt 166 , the disc sector 110 to be removed is simply moved radially outwardly and away from the hub 108 . As the disc sector 110 is moved away from the hub 108 , the opposed faces 138 and 140 of the groove 124 and the corresponding engagement surfaces 148 and 150 of the tongue section 146 slide radially past each other so that the disc sector 110 moves smoothly out of the hub 108 . In substantially the reverse of the above-described removal procedure, a replacement disc sector 110 is placed into contact with the hub 108 so that the replacement disc sector 110 and the hub 108 cooperatively form a tongue-and-groove connection extending along the periphery of the hub 108 . In making such tongue-and-groove connection, the engagement surfaces 148 and 150 of the tongue section 146 of the replacement disc sector 110 contact and slide into a snug connection with the corresponding opposed faces 138 and 140 of the groove 124 . As the replacement disc sector 110 is inserted into the groove 124 of the hub 108 , the generally flat radially extending side surfaces 132 and 134 of the replacement disc sector 110 slidingly engage the corresponding side surfaces 132 and 134 of the adjacent disc sectors 110 already secured to the hub 108 . As is shown particularly in FIG. 8 , this sliding engagement of the side surfaces 132 and 134 allows removal and insertion of a single disc sector 110 relative to the hub 108 without removing other disc sectors 110 . Finally, the connecting bolt 166 is inserted into the hole 168 in the hub 108 and extended axially through the hole 170 in the replacement disc sector 110 to secure the disc sector 110 to the hub 108 . As will be readily appreciated by one of ordinary skill in the art, the ability to replace a disc sector 110 with manipulation of only a single connecting bolt 166 and without disturbance of the other disc sectors 110 in the sectored disc assembly 38 allows for replacement in an efficient and simple manner as described above. The preferred forms of the invention described above are to be used as illustration only, and should not be utilized in a limiting sense in interpreting the scope of the present invention. Obvious modifications to the exemplary embodiments, as hereinabove set forth, could be readily made by those skilled in the art without departing from the spirit of the present invention. The inventor hereby states his intent to rely on the Doctrine of Equivalents to determine and access the reasonably fair scope of the present invention as pertains to any apparatus not materially departing from but outside the literal scope of the invention set forth in the following claims.

1a

[0001] This application claims the benefit under 35 U.S.C. §120 of U.S. patent application Ser. No. 10/158,412 filed on May 29, 2002, by Chien-Hsuan Han et al., entitled Combination Immediate Release Sustained Release Levodopa/Carbidopa Dosage Forms, which is incorporated herein by reference in its entirety. FIELD OF THE INVENTION [0002] The present invention relates to dosage forms of a combination of carbidopa and levodopa comprising both immediate release and controlled release components for the treatment of ailments associated with depleted amounts of dopamine in a patient's brain tissue. BACKGROUND [0003] Combinations of carbidopa and levodopa to treat Parkinson's disease are known in the pharmaceutical arts. Several products currently on the North American market, including SINEMET® and SINEMET® CR contain combinations of carbidopa and levodopa in immediate release and controlled release forms, respectively. Overseas, other decarboxylase inhibitor and levodopa combinations include those sold under the mark Madopark (levodopa with benserizide instead of carbidopa). [0004] The carbidopa and levodopa combination is used to treat the symptoms of Parkinson's disease, which is characterized by abnormally low levels of dopamine. Dopamine is a neurotransmitter having significant influence over the mobility and control of the skeletal muscular system. Patients suffering from Parkinson's disease frequently have periods in which their mobility becomes difficult, often resulting in an inability to move. [0005] Administering dopamine is not effective to treat Parkinson's disease because dopamine does not cross the blood brain barrier. To resolve this failure, Parkinson's patients are administered levodopa, the metabolic precursor of dopamine. Levodopa crosses the blood brain barrier and is rapidly converted to dopamine, thereby alleviating the symptoms of Parkinson's disease caused by reduced levels of dopamine. Levodopa is problematic because of its rapid decarboxylation by tissues other than the brain. Thus, when levodopa is administered alone, large doses are required because only a small portion is transported to the brain unchanged. [0006] Patients treated with levodopa therapy for Parkinson's disease may frequently develop motor fluctuations characterized by end-of-dose failure, peak dose dyskinesia and akinesia. An advanced form of motor fluctuations is known as the “on-off effect” in which the patient suffers from unpredictable swings from mobility to immobility. It is believed that the on-off effect can be minimized in some patients with a treatment regimen which produces narrow ranges of plasma levels of levodopa. [0007] Carbidopa inhibits the decarboxylation of levodopa by a patient's body tissues outside of the brain. Small doses of carbidopa administered in conjunction with levodopa allow a larger percentage of levodopa to reach the brain unchanged for later conversion to dopamine. There is at least one study reporting that carbidopa reduces the amount of levodopa required to produce a given response by about 75% and, when administered in conjunction with levodopa, increases plasma levels and the plasma half life of levodopa. The carbidopa and levodopa combination allows for lower doses of levodopa with a concordant reduction of side effects. [0008] The carbidopa and levodopa combination is now available in immediate release as well as controlled release compositions. The controlled release formulations allow for the continuous release of drug over a prolonged period in an attempt to maintain tight levodopa plasma ranges. However, the use of controlled release dosage forms are problematic in that many Parkinson's patients wake up in the morning having little or no mobility due to the wearing off of the previous dose taken the day or evening before. Once the previous dose has worn off, such patients are usually unwilling or unable to wait for the extended period of time required for a controlled release dosage form to deliver the appropriate plasma levels of levodopa. The use of immediate release formulations require more frequent dosing and are associated with more fluctuating plasma levodopa concentrations. [0009] Combination immediate release and controlled release carbidopa and levodopa dosage forms are described in U.S. Pat. No. 6,238,699 to Rubin, entitled Pharmaceutical Formulations Containing A Combination Of Carbidopa And Levodopa, issued May 29, 2001, which discloses an immediate release and controlled release carbidopa and levodopa combination product, and is incorporated herein by reference. [0010] There remains, however, a continuing need for immediate release and controlled release carbidopa and levodopa products which will improve the administration of levodopa to Parkinson's patients by narrowing blood plasma ranges of levodopa and reducing side effects. SUMMARY OF THE INVENTION [0011] The present invention is directed to a pharmaceutical dosage form having an immediate release component and a controlled release component. The immediate release component comprises a ratio of carbidopa to levodopa of from about 1:1 to about 1:50 such that the in vitro dissolution rate of the immediate release component is from about 10% to about 99% levodopa released after 15 minutes and from about 60% to about 99% levodopa released after 1 hour. The controlled release component comprises a ratio of carbidopa to levodopa of from about 1:1 to about 1:50 such that the in vitro dissolution rate of the controlled release component is from about 10% to about 60% levodopa released after 1 hour; from about 20% to about 80% levodopa released after 2 hours; and from about 30% to about 99% levodopa released after about 6 hours according to measurements under the USP paddle method of 50 rpm in 900 ml aqueous buffer at pH 4 at 37° C. The in vitro release rate is chosen such that the initial peak plasma level of levodopa obtained in vivo occurs between 0.1 and 6 hours after administration of the dosage form. BRIEF DESCRIPTION OF THE DRAWINGS [0012] [0012]FIG. 1 is a graph of the dissolution profiles of carbidopa/levodopa immediate release (IR) 25/100 mg formulations PX03002 and PX03102 according to measurements under the USP paddle method of 50 rpm in 900 ml acetate buffer at pH 4 at 37° C. [0013] [0013]FIG. 2 is a graph of the dissolution profile of a carbidopa/levodopa controlled release (CR) 50/200 mg formulation PX00502 according to measurements under the USP paddle method of 50 rpm in 900 ml acetate buffer at pH 4 at 37° C. [0014] [0014]FIG. 3 is a graph of the dissolution profiles of carbidopa/levodopa 75/300 mg formulations PX03602 and PX04002 according to measurements under the USP paddle method of 50 rpm in 900 ml acetate buffer at pH 4 at 37° C. [0015] [0015]FIG. 4 is a graph of the dissolution profiles of carbidopa/levodopa immediate release (IR) 25/100 mg formulations PX00102, PX02001, and Brand K5370 according to measurements under the USP paddle method of 50 rpm in 900 ml at pH 1.2(0.1 N HCL) at 37° C. [0016] [0016]FIG. 5 is a graph of the dissolution profiles of carbidopa/levodopa controlled release (CR) 50/200 mg formulations PX00302, PX00502, and Brand 01023 according to measurements under the USP paddle method of 50 rpm in 900 ml at pH 1.2(0.1 N HCL) at 37° C. [0017] [0017]FIG. 6 is a graph of the dissolution profiles of carbidopa/levodopa formulations PX03602 (controlled release, 75/300 mg), PX04002 (controlled release, 75/300 mg), Brand K5370 (immediate release, 25/100 mg), and Brand 01023 (controlled release, 50/200 mg) according to measurements under the USP paddle method of 50 rpm in 900 ml at pH 1.2 (0.1 N HCL) at 37° C. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0018] The present invention is directed to methods of treating symptoms, pathologies or diseases characterized by reduced levels of dopamine in a patients brain, including neurological or movement disorders such as restless leg syndrome, Parkinson's disease and secondary parkinsonism, Huntingdon's disease, Shy-Drager syndrome and conditions resulting from brain injury including carbon monoxide or manganese intoxication. [0019] The present invention is directed to a pharmaceutical dosage form having an immediate release component and a controlled release component. The immediate release component comprises carbidopa alone or a ratio of carbidopa to levodopa from about 1:1 to about 1:50 such that the in vitro dissolution rate of the immediate release component, according to measurements under the USP paddle method of 50 rpm in 900 ml aqueous buffer at pH 4 at 37° C., is from about 10% to about 99% active agent released after 15 minutes and from about 75% to about 99% active agent released after 1 hour. Benzeraside as an alternate peripheral decarboxylase inhibitor, and may be substituted in appropriate doses in all subsequent details of the carbidopa discussions. The controlled release component comprises a ratio of levodopa to carbidopa of from about 1:2 to about 1:50 such that the in vitro dissolution rate of the controlled release component, according to measurements under the USP paddle method of 50 rpm in 900 ml aqueous buffer at pH 4 at 37° C., is about 10% to about 60% levodopa released after 1 hour; from about 25% to about 80% levodopa released after 2 hours; and, from about 40% to about 95% levodopa released after 6 ours. Additionally, the formulations of the present invention are chosen such that the initial peak plasma level of levodopa obtained in vivo occurs between 0.1 and 6 hours after administration of the dosage form. [0020] The ratio of immediate release to controlled release Levodopa in dosage forms according to the present invention is from about 3 to about 0.1. The skilled artisan will appreciate that this ratio can range anywhere within these endpoints depending on the goal of therapy and such well known factors such as patient weight, stage of disease, etc. The skilled artisan will appreciate that the ratios of 1, 0.875, 0.538, 0.5 and 0.33, which are used in dosage forms according to the present invention, are representative of specific ratios, but not limiting of the possible ratios which may be employed in carbidopa/levodopa dosage forms. [0021] For purposes of the present invention the term “controlled release” refers to a pharmaceutical dosage form which releases one or more active pharmaceutical agents over a prolonged period of time, in this case over a period of more than 1 hour. Controlled release (CR) components can also be referred to as sustained release (SR), prolonged release (PR), or extended release (ER). When used in association with the dissolution profiles discussed herein, the term “controlled release” refers to that portion of a dosage form made according to the present invention which delivers active agent over a period of time greater than 1 hour. “Immediate release” refers to a dosage form which releases active agent substantially immediately upon contact with gastric juices and will result in substantially complete dissolution within about 1 hour. Immediate release (IR) components can also be referred to as instant release. When used in association with the dissolution profiles discussed herein, the term “immediate release” refers to that portion of a dosage form made according to the present invention which delivers active agent over a period of time less than 1 hour. [0022] Initial peak plasma level refers to the first rise in blood plasma level of active agent and may be followed by one or more additional peaks, one of which may be C max . [0023] The USP paddle method refers to the Paddle and Basket Method as described in United States Pharmacopoeia, Edition XXII (1990). [0024] As used herein, the term patient means any mammal including humans. [0025] The active agents for use in dosage forms according to the present invention include levodopa and carbidopa their salts, derivatives and pro-drugs. The terms “levodopa” and “carbidopa” are meant to embrace these chemical compounds themselves, pro-drugs thereof, N-oxides thereof, the pharmaceutically acceptable salts thereof, derivatives thereof, and the solvates thereof, e.g. hydrates, where the context so permits. Similarly, reference to intermediates, whether or not they themselves are claimed, is meant to embrace their salts, and solvates, where the context so permits. [0026] The term “derivative” means a chemically modified compound wherein the modification is considered routine by the ordinary skilled chemist, such as an ester or an amide of an acid, protecting groups, such as a benzyl group for an alcohol or thiol, and tert-butoxycarbonyl group for an amine. [0027] The term “effective amount” means an amount of a compound/composition according to the present invention effective in producing the desired therapeutic effect. [0028] The term “analogue” means a compound which comprises a chemically modified form of a specific compound or class thereof, and which maintains the pharmaceutical and/or pharmacological activities characteristic of said compound or class. [0029] As used herein, “pharmaceutically acceptable salts” refer to derivatives of the disclosed compounds wherein the parent compound is modified by making acid or base salts thereof. Examples of pharmaceutically acceptable salts include, but are not limited to, mineral or organic acid salts of basic residues such as amines; alkali or organic salts of acidic residues such as carboxylic acids; and the like. The pharmaceutically acceptable salts include the conventional non-toxic salts or the quarternary ammonium salts of the parent compound formed, for example, from non-toxic inorganic or organic acids. For example, such conventional non-toxic salts include those derived from inorganic acids such as hydrochloric, hydrobromic, sulfuric, sulfamic, phosphoric, nitric and the like; and the salts prepared from organic acids such as acetic, propionic, succinic, glycolic, stearic, lactic, malic, tartaric, citric, ascorbic, pamoic, maleic, hydroxymaleic, phenylacetic, glutamic, benzoic, salicylic, sulfanilic, 2-acetoxybenzoic, fumaric, toluensulfonic, methanesulfonic, ethane dislfonic, oxalic, isethionic, and the like. [0030] The phrase “pharmaceutically acceptable” is employed herein to refer to those compounds, materials, compositions; and/or dosage forms which are, within the scope of sound medical judgment, suitable for use in contact with the tissues of human beings and animals without excessive toxicity, irritation, allergic response, or other problem or complication commensurate with a reasonable benefit/risk ratio. [0031] The term “about” when used in connection with percentages means ±1%. [0032] The term “Pro-drugs”, as the term is used herein, is intended to include any covalently bonded carriers which release an active parent drug of the present invention in vivo when such pro-drug is administered to a mammalian subject. Since pro-drugs are known to enhance numerous desirable qualities of pharmaceuticals (i.e., solubility, bioavailability, manufacturing, etc.) the compounds of the present invention may be delivered in pro-drug form. Thus, the present invention is intended to cover pro-drugs of the presently claimed compounds, methods of delivering the same, and compositions containing the same. [0033] One example of a pro-drug for levodopa is 3-hydroxy-L-tyrosine ethyl ester. In the formulations of the present invention, 3-hydroxy-L-tyrosine ethyl ester can be used in combination with levodopa or as a replacement for levodopa in any of the formulations. Generally, an appropriate pro-drug for levodopa can be used in combination with levodopa or as a replacement for levodopa in any of the levodopa/carbidopa formulations of the present invention. Similarly, an appropriate pro-drug for carbidopa can be used in combination with levodopa or as a replacement for carbidopa in any of the levodopa/carbidopa formulations of the present invention. [0034] Pro-drugs of the present invention are prepared by modifying functional groups present in the compound in such a way that the modifications are cleaved, either in routine manipulation or in vivo, to the parent compound. The transformation in vivo may be, for example, as the result of some metabolic process, such as chemical or enzymatic hydrolysis of a carboxylic, phosphoric or sulphate ester, or reduction or oxidation of a susceptible functionality. Pro-drugs within the scope of the present include compounds wherein a hydroxy, amino, or sulfhydryl group is bonded to any group that, when the pro-drug of the present invention is administered to a mammalian subject, it cleaves to form a free hydroxyl, free amino, or free sulfydryl group respectively. Functional groups which may be rapidly transformed, by metabolic cleavage, in vivo form a class of groups reactive with the carboxyl group of the compounds of this invention. They include, but are not limited to such groups as alkanoyl (such as acetyl, propionyl, butyryl, and the like), unsubstituted and substituted aroyl (such as benzoyl and substituted benzoyl), alkoxycarbonyl (such as ethoxycarbonyl), trialkysilyl (such as trimethyl- and triethysilyl), monoesters formed with dicarboxylic acids (such as succinyl), and the like. Because of the ease with which metabolically cleavable groups of the compounds useful according to this invention are cleaved in vivo, the compounds bearing such groups act as pro-drugs. The compounds bearing the metabolically cleavable groups have the advantage that they may exhibit improved bioavailability as a result of enhanced solubility and/or rate of absorption conferred upon the parent compound by virtue of the presence of the metabolically cleavable group. [0035] A thorough discussion of pro-drugs is provided in the following: Design of Pro-drugs, H. Bundgaard, ed., Elsevier, 1985; Methods in Enzymology, K. Widder et al., ed., Academic Press, 42, p.309-396, 1985; A Textbook of Drug Design and Development, Krogsgaard-Larsen and H. Bundgaard, ed., Chapter5; “Design and Applications of Pro-drugs” p.113-191, 1991; Advanced Drug Delivery Reviews, H. Bundgard, 8, p.1-38, 1992; Journal of Pharmaceutical Sciences, 77, p. 285, 1988; Chem. Pharm. Bull., N. Nakeya et al., 32, p. 692, 1984; Pro-drugs as Novel Delivery Systems, T. Higuchi and V. Stella, Vol. 14 of the A.C.S. Symposium Series, and Bioreversible Carriers in Drug Design, Edward B. Roche, ed., American Pharmaceutical Association and Pergamon Press, 1987, each of which is incorporated herein by reference. [0036] Total daily dosages of the compounds useful according to this invention administered to a host in single or divided doses are generally in amounts of from about 0.01 mg/kg to about 100 mg/kg body weight daily, and preferably from about 0.05 mg/kg to about 50 mg/kg body weight daily. Both the levodopa and carbidopa doses fall within this mg/kg/day dosage range. The relative amounts of carbidopa and levodopa can vary from about 1:1 to about 1:50 in dosage forms according to the present invention. Other dosage ratios useful according to the present invention include 1:10, 5:26, 1:5, 1:4, 5:16, 1:3, 5:14, 1:2, 2:3, 3:4, 5:6) of carbidopa to levodopa. [0037] The skilled artisan will appreciate that daily dosages having an amount of active agent sufficient to treat Parkinson's disease will generally contain from about 25 mg to about 4,000 mg of levodopa in combination with from about 5 mg to about 600 mg of carbidopa. Dosage forms according to the present invention may also contain from about 25 or preferably 100 mg to about preferably 300 or 600 mg of levodopa in combination with from about 12.5 or preferably 50 mg to about preferably 75 or 200 mg of carbidopa. Preferred dosage forms contain 25, 37.5, 50, 70, 75, 80, 100, 125, 130, 150, 200, 250, 300, 400, or 600 mg of levodopa and 12.5, 25, 37.5, 50, 75, 100, 112.5, 125 or 150 mg of carbidopa. Preferred dosage forms include all possible combinations of these amounts of levodopa and carbidopa. Dosage unit compositions may also contain amounts of levodopa and carbidopa in percentages of these dosages as may be used to make up the daily dose. It will be understood, however, that the specific dose level for any particular patient will depend upon a variety of factors including body weight, general health, gender, diet, time and route of administration, rates of absorption and excretion, combination with other drugs, and the severity of the particular disease being treated. [0038] Actual dosage levels of active ingredient in the compositions of the present invention may be varied so as to obtain an amount of active ingredient that is effective to obtain a desired therapeutic response for a particular composition and method of administration. The selected dosage level, therefore, depends upon the desired therapeutic effect, on the route of administration, on the desired duration of treatment, and other factors. [0039] The dosage forms of the present invention are designed to administer active agent according to the combination of two release profiles. The first profile is an immediate release burst of carbidopa, another decarboxylase inhibitor such as benserazide, or a combination of active ingredients such as a decarboxylase inhibitors and levodopa to provide early relief from symptoms via quick onset of effective blood plasma levels of active agent. Such early release is such that the in vitro dissolution rate of the immediate release component, according to measurements under the USP paddle method of 50 rpm in 900 ml aqueous buffer at pH 4 at 37° C. are from about 10% to about 99% levodopa released after 15 minutes and from about 75% to about 99% levodopa released after 1 hour. [0040] The second profile is a controlled release profile in which the combination of active ingredients is released slowly over time to provide a plasma level effective to alleviate the symptoms of Parkinson's disease over a prolonged period. This controlled release profile may be over a period of 3, 4, 6, 8, 12, or 24 hours. Furthermore, the controlled release profile of the present invention is such that the in vitro dissolution rate of the controlled release component, according to measurements under the USP paddle method of 50 rpm in 900 ml aqueous buffer at pH 4 at 37° C., are from about 10% to about 60% levodopa released after 1 hour; from about 25% to about 80% released after 2 hours; from about 30% to about 85% levodopa released after 4 hours and from about 40% to about 99% levodopa released after about 6 hours, and chosen such that the peak plasma level of levodopa obtained in vivo occurs between 0.1 and 6 hours after administration of the dosage form. [0041] The active ingredients of the present invention may be mixed with pharmaceutically acceptable carriers, diluents, adjuvants, excipients, or vehicles, such as preserving agents, fillers, polymers, disintegrating agents, glidants, wetting agents, emulsifying agents, suspending agents, sweetening agents, flavoring agents, perfuming agents, lubricating agents, acidifying agents, and dispensing agents, depending on the nature of the mode of administration and dosage forms. Such ingredients, including pharmaceutically acceptable carriers and excipients that may be used to formulate oral dosage forms, are described in the Handbook of Pharmaceutical Excipients , American Pharmaceutical Association (1986), incorporated herein by reference in its entirety. Examples of, pharmaceutically acceptable carriers include water, ethanol, polyols, vegetable oils, fats, waxes polymers, including gel forming and non-gel forming polymers, and suitable mixtures thereof. Examples of excipients include starch, pregelatinized starch, Avicel, lactose, milk sugar, sodium citrate, calcium carbonate, dicalcium phosphate, and lake blend. Examples of disintegrating agents include starch, alginic acids, and certain complex silicates. Examples of lubricants include magnesium stearate, sodium lauryl sulphate, talc, as well as high molecular weight polyethylene glycols. The artisan of ordinary skill in the art will recognize that many different excipients can be used in formulations according to the present invention and the list provided herein is not exhaustive. Dosage Forms [0042] Dosage forms can be made according to well known methods in the art. Some preferred methods are described below. Matrix Dosage Forms [0043] The term matrix, as used herein, is given its well known meaning in the pharmaceutical arts, that is a solid material having an active agent incorporated therein. Upon exposure to a dissolution media, channels are formed in the solid material so that the active agent can escape. Dosage forms according to one embodiment of the present invention may be in the form of coated or uncoated matrices. A coating, for example may contain immediate release carbidopa alone, or in the alternative, a combination of levodopa and carbidopa, and the matrix itself can contain the controlled release combination of levodopa and carbidopa. [0044] The skilled artisan will appreciate that the matrix material can be chosen from a wide variety of materials which can provide the desired dissolution profiles. Materials can include, for example, one or more gel forming polymers such as polyvinyl alcohol, cellulose ethers including, for example, hydroxy propyl alkyl, celluloses such as hydroxypropyl methyl cellulose, hydroxy alkyl celluloses such as hydroxy propyl cellulose, natural or synthetic gums such as guar gum, xanthum gum, and alginates, as well as, ethyl cellulose, polyvinyl pyrrolidone, fats, waxes, polycarboxylic acids or esters such as the Carbopol ® series of polymers, methacrylic acid copolymers, and methacrylate polymers. [0045] Methods of making matrix dosages are well known in the art and any known method of making such dosages which yields the desired immediate release and controlled release dissolution profiles can be used. One such method involves the mixture of the levodopa and carbidopa combination with a solid polymeric material and one or more pharmaceutically acceptable excipients which are then blended and compressed in controlled release tablet cores. Such tablet cores can be used for further processing as bi-layer tablets, press coated tablets, or film coated tablets. [0046] A coating containing the immediate release carbidopa or carbidopa and levodopa in combination can be added to the outside of the controlled release tablet cores to produce a final dosage form. Such a coating can be prepared by mixing carbidopa alone, or a combination of levodopa and carbidopa, with polyvinylpyrrolidone (PVP) 29/32 or hydroxypropyl methylcellulose (HPMC) and water/isopropyl alcohol and triethyl acetate. Such an immediate release coating can be spray coated onto the tablet cores. The immediate release coating may also be applied using a press-coating process with a blend consisting of 80% by weight levodopa and carbidopa and 20% by weight of lactose and hydroxypropyl methylcellulose type 2910. Press coating techniques are known in the art and are described in U.S. Pat. No. 6,372,254 to Ting et al., incorporated herein by reference in its entirety. [0047] In addition, the formulation of respective release components can occur by appropriate granulation methods as is well known in the art. In wet granulation, solutions of the binding agent (polymer) are added with stirring to the mixed powders. The powder mass is wetted with the binding solution until the mass has the consistency of damp snow or brown sugar. The wet granulated material is forced through a sieving device. Moist material from the milling step is dried by placing it in a temperature controlled container. After drying, the granulated material is reduced in particle size by passing it through a sieving device. Lubricant is added, and the final blend is then compressed into a matrix dosage form. [0048] In fluid-bed granulation, particles of inert material and/or active agent are suspended in a vertical column with a rising air stream. While the particles are suspended, a common granulating material in solution is sprayed into the column. There is a gradual particle buildup under a controlled set of conditions resulting in tablet granulation. Following drying and the addition of lubricant, the granulated material is ready for compression. [0049] In dry-granulation, the active agent, binder, diluent, and lubricant are blended and compressed into tablets. The compressed large tablets are comminuted through the desirable mesh screen by sieving equipment. Additional lubricant is added to the granulated material and blended gently. The material is then compressed into tablets. Particle Based Dosage Forms Immediate Release Particles [0050] The immediate release/controlled release dosage forms of the present invention can also take the form of pharmaceutical particles. The dosage forms can include immediate release particles in combination with controlled release particles in a ratio sufficient to deliver the desired dosages of active agents. The controlled release particles can be produced by coating the immediate release particles. [0051] The particles can be produced according to any of a number of well known methods for making particles. The immediate release particles comprise the active agent combination and a disintegrant. Suitable disintegrants include, for example, starch, low-substitution hydroxypropyl cellulose, croscarmellose sodium, calcium carboxymethyl cellulose, hydroxypropyl starch, and microcrystalline cellulose. [0052] In addition to the above-mentioned ingredients, a controlled release matrix may also contain suitable quantities of other materials, for example, diluents, lubricants, binders, granulating aids, colorants, flavorants, and glidants that are conventional in the pharmaceutical arts. The quantities of these additional materials are sufficient to provide the desired effect to the desired formulation. A controlled release matrix incorporating particles may also contain suitable quantities of these other materials such as diluents, lubricants, binders, granulating aids, colorants, flavorants, and glidants that are conventional in the pharmaceutical arts in amounts up to about 75% by weight of the particulate, if desired. [0053] Particles can assume any standard structure known in the pharmaceutical arts. Such structures include, for example, matrix particles, non-pareil cores having a drug layer and active or inactive cores having multiple layers thereon. A controlled release coating can be added to any of these structures to create a controlled release particle. [0054] The term particle as used herein means a granule having a diameter of between about 0.01 mm and about 5.0 mm, preferably between about 0.1 mm and about 2.5 mm, and more preferably between about 0.5 mm and about 2 mm. The skilled artisan will appreciate that particles according to the present invention can be any geometrical shape within this size range and so long as the mean for a statistical distribution of particles falls within the particle sizes enumerated above, they will be considered to fall within the contemplated scope of the present invention. [0055] The release of the therapeutically active agent from the controlled release formulation of the present invention can be further influenced, i.e., adjusted to a desired rate, by the addition of one or more release-modifying agents. The release-modifying agent may be organic or inorganic and include materials that can be dissolved, extracted, or leached from the coating in the environment of use. The pore-formers may comprise one or more hydrophilic materials such as hydroxypropyl methylcellulose. The release-modifying agent may also comprise a semi-permeable polymer. In certain preferred embodiments, the release-modifying agent is selected from hydroxypropyl methyclcellulose, lactose, metal stearates, and mixtures thereof. [0056] In one preferred embodiment, oral dosage forms are prepared to include an effective amount of particles as described above within a capsule. For example, melt-extruded particles may be placed in a gelatin capsule in an amount sufficient to provide an effective controlled release dose when ingested and contacted by gastric fluid. In another preferred embodiment, a suitable amount of the particles are compressed into an oral tablet using conventional tableting equipment using standard techniques. Techniques and compositions for making tablets (compressed and molded), capsules (hard and soft gelatin), and pills are also described in Remington's Pharmaceutical Sciences , Arthur Osol, editor, pp. 1553-1593 (1980), incorporated herein by reference. The particles can be made by mixing the relevant ingredients and granulating the mixture. The resulting particles are dried and screened, and the particles having the desired size are used for drug formulation. Controlled Release Particles [0057] The controlled release particles of the present invention slowly release the combination of levodopa and carbidopa when ingested and exposed to gastric fluids, and then to intestinal fluids. The controlled release profile of the formulations of the invention can be altered, for example, by increasing or decreasing the thickness of the retardant coating, i.e., by varying the amount of overcoating. The resultant solid controlled release particles may thereafter be placed in a gelatin capsule in an amount sufficient to provide an effective controlled release dose when ingested and contacted by an environmental fluid, e.g., gastric fluid, intestinal fluid or dissolution media. The particles may be overcoated with an aqueous dispersion of a hydrophobic or hydrophilic material to modify the release profile. The aqueous dispersion of hydrophobic material preferably further includes an effective amount of plasticizer, e.g. triethyl citrate. Preformulated aqueous dispersions of ethylcellulose, such as Aquacoat® or Surelease®, may be used. If Surelease® is used, it is not necessary to separately add a plasticizer. [0058] The hydrophobic material may be selected from the group consisting of alkylcellulose, acrylic and methacrylic acid polymers and copolymers, shellac, zein, hydrogenated castor oil, hydrogenated vegetable oil, or mixtures thereof. In certain preferred embodiments, the hydrophobic material is a pharmaceutically acceptable acrylic polymer, including but not limited to acrylic acid and methacrylic acid copolymers, methyl methacrylate, methyl methacrylate copolymers, ethoxyethyl methacrylates, cyanoethyl methacrylate, aminoalkyl methacrylate copolymer, poly(acrylic acid), poly(methacrylic acid), methacrylicacid alkylamine copolymer, poly(methyl methacrylate), poly(methacrylic acid anhydride), polymethacrylate, polyacrylamide, poly(methacrylic acid anhydride), and glycidyl methacrylate copolymers. In alternate embodiments, the hydrophobic material is selected from materials such as one or more hydroxyalkyl celluloses such as hydroxypropyl methycellulose. The hydroxyalkyl cellulose is preferably a hydroxy (C 1 to C 6 ) alkyl cellulose, such as hydroxypropylcellulose, hydroxypropylmethylcellulose, or preferably hydroxyethylcellulose. The amount of the hydroxyalkyl cellulose in the present oral dosage form is determined, inter alia, by the precise rate of active agents desired and may vary from about 1% to about 80%. [0059] In embodiments of the present invention where the coating comprises an aqueous dispersion of a hydrophobic polymer, the inclusion of an effective amount of a plasticizer in the aqueous dispersion of hydrophobic polymer can further improve the physical properties of the film. For example, because ethylcellulose has a relatively high glass transition temperature and does not form flexible films under normal coating conditions, it is necessary to plasticize the ethylcellulose before using it as a coating material. Generally, the amount of plasticizer included in a coating solution is based on the concentration of the film-former, e.g., most often from about 1 percent to about 50 percent by weight of the film-former. Concentration of the plasticizer, however, is preferably determined after careful experimentation with the particular coating solution and method of application. [0060] Examples of suitable plasticizers for ethylcellulose include water-insoluble plasticizers such as dibutyl sebacate, diethyl phthalate, triethyl citrate, tributyl citrate, and triacetin, although other water-insoluble plasticizers (such as acetylated monoglycerides, phthalate esters, castor oil, etc.) may be used. Triethyl citrate is an especially preferred plasticizer for the aqueous dispersions of ethyl cellulose of the present invention. [0061] Examples of suitable plasticizers for the acrylic polymers of the present invention include, but are not limited to, citric acid esters such as triethyl citrate NF XVI, tributyl citrate, dibutyl phthalate, and possibly 1, 2-propylene glycol. Other plasticizers which have proved to be suitable for enhancing the elasticity of the films formed from acrylic films such as Eudragit® RL/RS lacquer solutions include polyethylene glycols, propylene glycol, diethyl phthalate, castor oil, and triacetin. Triethyl citrate is an especially preferred plasticizer for aqueous dispersions of ethyl cellulose. It has further been found that addition of a small amount of talc reduces the tendency of the aqueous dispersion to stick during processing and acts a polishing agent. [0062] One commercially available aqueous dispersion of ethylcellulose is Aquacoat® which is prepared by dissolving the ethylcellulose in a water-immiscible organic solvent and then emulsifying the ethylcellulose in water in the presence of a surfactant and a stabilizer. After homogenization to generate submicron droplets, the organic solvent is evaporated under vacuum to form a pseudolatex. The plasticizer is not incorporated into the pseudolatex during the manufacturing phase. Thus, prior to using the pseudolatex as a coating, the Aquacoat® is mixed with a suitable plasticizer. [0063] Another aqueous dispersion of ethylcellulose is commercially available as Surelease® (Colorcon, Inc., West Point, Pa., U.S.A.). This product is prepared by incorporating plasticizer into the dispersion during the manufacturing process. A hot melt of a polymer, plasticizer (dibutyl sebacate), and stabilizer (oleic acid) is prepared as a homogeneous mixture which is then diluted with an alkaline solution to obtain an aqueous dispersion which can be applied directly onto substrates. [0064] In one preferred embodiment, the acrylic coating is an acrylic resin lacquer used in the form of an aqueous dispersion, such as that which is commercially available from Rohm Pharma under the trade name Eudragit®. In additional preferred embodiments, the acrylic coating comprises a mixture of two acrylic resin lacquers commercially available from Rohm Pharma under the trade names Eudragit® RL 30 D and Eudragit® RS 30 D. Eudragit® RL 30 D and Eudragit® RS 30 are copolymers of acrylic and methacrylic esters with a low content of quaternary ammonium groups, the molar ratio of ammonium groups to the remaining neutral (meth)acrylic esters being 1:20 in Eudragit® RL 30 and 1:40 in Eudragit® RS 30 D. The mean molecular weight is about 150,000 Daltons. The code designations RL (high permeability) and RS (low permeability) refer to the permeability properties of these agents. Eudragit® RL/RS mixtures are insoluble in water and in digestive fluids, however, coatings formed from them are swellable and permeable in aqueous solutions and digestive fluids. [0065] The Eudragit® RL/RS dispersions may be mixed together in any desired ratio in order to ultimately obtain a controlled-release formulation having a desirable dissolution profile. Desirable controlled-release formulations may be obtained, for instance, from a retardant coating derived from one of a variety of coating combinations, such as 100% Eudragit® RL; 50% Eudragit® RL and 50% Eudragit® RS; or 10% Eudragit® RL and Eudragit® 90% RS. Of course, one skilled in the art will recognize that other acrylic polymers may also be used, for example, Eudragit®L. In addition to modifying the dissolution profile by altering the relative amounts of different acrylic resin lacquers, the dissolution profile of the ultimate product may also be modified, for example, by increasing or decreasing the thickness of the retardant coating. [0066] In preferred embodiments of the present invention, the stabilized product is obtained by subjecting the coated substrate to oven curing at a temperature above the Tg of the plasticized acrylic polymer for the required time period, the optimum values for temperature and time for the particular formulation being determined experimentally. In certain embodiments of the present invention, the stabilized product is obtained via an oven curing conducted at a temperature of about 45° C. for a time period from about 1 to about 48 hours. It is also contemplated that certain products coated with the controlled-release coating of the present invention may require a curing time longer than 24 to 48 hours, e.g., from about 48 to about 60 hours or more. [0067] The coating solutions preferably contain, in addition to the film-former, plasticizer, and solvent system (i.e., water), a colorant to provide elegance and product distinction. Color may be added to the solution of the therapeutically active agent instead of, or in addition to the aqueous dispersion of hydrophobic material. For example, color may be added to Aquacoat® via the use of alcohol or propylene glycol based color dispersions, milled aluminum lakes and opacifiers such as titanium dioxide by adding color with shear to the water soluble polymer solution and then using low shear to the plasticized Aquacoat®. Alternatively, any suitable method of providing color to the formulations of the present invention may be used. Suitable ingredients for providing color to the formulation when an aqueous dispersion of an acrylic polymer is used include titanium dioxide and color pigments, such as iron oxide pigments. The incorporation of pigments, may, however, increase the retardant effect of the coating. [0068] Spheroids or beads coated with the therapeutically active agents can be prepared, for example, by dissolving the therapeutically active agents in water and then spraying the solution onto a substrate, for example, non pareil 18/20 beads, using a Wuster insert. Optionally, additional ingredients are also added prior to coating the beads in order to assist the binding of the active agents to the beads, and/or to color the solution, etc. For example, a product which includes hydroxypropyl methycellulose with or without colorant (e.g., Opadry®, commercially available from Coloron, Inc.) may be added to the solution and the solution mixed (e.g., for about 1 hour) prior to application onto the beads. The resultant coated substrate, beads in this example, may then be optionally overcoated with a barrier agent to separate the therapeutically active agent from the hydrophobic controlled release coating. An example of a suitable barrier agent is one which comprises hydroxypropylmethylcellulose. However, any film-former known in the art may be used. It is preferred that the barrier agent does not affect the dissolution rate of the final product. [0069] Immediate release particles according to the present invention may be coated with a controlled release coating in order to change the release rate to obtain the dissolution rates according to the present invention. Press Coated, Pulsatile Dosage Form [0070] In another embodiment of the present invention, the carbidopa and levodopa combination is administered via a press coated pulsatile drug delivery system suitable for oral administration with a controlled release component, which contains a compressed blend of an active agent and one or more polymers, substantially enveloped by an immediate release component, which contains a compressed blend of the active agent and hydrophilic and hydrophobic polymers. The immediate-release component preferably comprises a compressed blend of active agent and one or more polymers with disintegration characteristics such that the polymers disintegrate rapidly upon exposure to the aqueous medium. [0071] The controlled-release component preferably comprises a combination of hydrophilic and hydrophobic polymers. In this embodiment, once administered, the hydrophilic polymer dissolves away to weaken the structure of the controlled-release component, and the hydrophobic polymer retards the water penetration and helps to maintain the shape of the drug delivery system. [0072] In accordance with the present invention, the term “polymer” includes single or multiple polymeric substances, which can swell, gel, degrade or erode on contact with an aqueous environment (e.g., water). Examples include alginic acid, carboxymethylcellulose calcium, carboxymethylcellulose sodium, colloidal silicon dioxide, croscarmellose sodium, crospovidone, guar gum, magnesium aluminum silicate, methylcellulose, microcrystalline cellulose, polacrilin potassium, powdered cellulose, pregelatinized starch, sodium alginate, sodium starch glycolate, starch, ethylcellulose, gelatin, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, polymethacrylates, povidone, pregelatinized starch, shellac, and zein, and combinations thereof. [0073] The term “hydrophilic polymers” as used herein includes one or more of carboxymethylcellulose, natural gums such as guar gum or gum acacia, gum tragacanth, or gum xanthan, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, methylcellulose, and povidone, of which hydroxypropyl methylcellulose is further preferred. The term “hydrophilic polymers” can also include sodium carboxymethycellulose, hydroxymethyl cellulose, polyethelene oxide, hydroxyethyl methyl cellulose, carboxypolymethylene, polyethelene glycol, alginic acid, gelatin, polyvinyl alcohol, polyvinylpyrrolidones, polyacrylamides, polymethacrylamides, polyphosphazines, polyoxazolidines, poly(hydroxyalkylcarboxylic acids), an alkali metal or alkaline earth metal, carageenate alginates, ammonium alginate, sodium alganate, or mixtures thereof. [0074] The hydrophobic polymer of the drug delivery system can be any hydrophobic polymer which will achieve the goals of the present invention including, but not limited to, one or more polymers selected from carbomer, carnauba wax, ethylcellulose, glyceryl palmitostearate, hydrogenated castor oil, hydrogenated vegetable oil type 1, microcrystalline wax, polacrilin potassium, polymethacrylates, or stearic acid, of which hydrogenated vegetable oil type 1 is preferred. Hydrophobic polymers can include, for example, a pharmaceutically acceptable acrylic polymer, including, but not limited to, acrylic acid and methacrylic acid copolymers, methyl methacrylate copolymers, ethoxyethyl methacrylates, cyanoethyl methacrylate, aminoalkyl methacrylate copolymer, poly(acrylic acid), poly(methacrylic acid), methacrylic acid alkylamide copolymer, poly(methyl methacrylate), poly(methyl methacrylate) copolymer, polyacrylamide, aminoalkyl methacrylate copolymer, poly(methacrylic acid anhydride), and glycidyl methacrylate copolymers. Additionally, the acrylic polymers may be cationic, anionic, or non-ionic polymers and may be acrylates, methacrylates, formed of methacrylic acid or methacrylic acid esters. The polymers may also be pH dependent. [0075] The present invention also provides a method for preparing a press coated, pulsatile drug delivery system suitable for oral administration. This method includes the steps of combining an effective amount of an active agent, or a pharmaceutically acceptable salt thereof, and a polymer to form an immediate-release component; combining an effective amount of an active agent, or a pharmaceutically acceptable salt thereof, and a combination of hydrophilic and hydrophobic polymers to form an controlled-release component; and press coating the controlled-release component to substantially envelop the immediate-release component. [0076] A preferred embodiment further includes the steps of combining an effective amount of an active agent, or a pharmaceutically acceptable salt thereof, and a polymer to form an immediate-release component, and press coating the immediate-release component to substantially envelop the controlled-release component. In another preferred embodiment, the combining steps can be done by blending, wet granulation, fluid-bed granulation, or dry granulation according to methods recognized in the art. [0077] The term “substantially envelop” is intended to define the total or near-total enclosure of a component. Such an enclosure includes, preferably, at least 80% enclosure, more preferably at least 90% enclosure, and most preferably at least 99% enclosure. [0078] The following examples describe and illustrate the processes and products of the present invention. These examples are intended to be merely illustrative of the present invention, and not limiting thereof in either scope or spirit. Those skilled in the art will readily understand that variations of the materials, conditions, and processes described in these examples can be used. All references cited herein are incorporated by reference. EXAMPLE 1 [0079] The method described below was employed to obtain a press coated, pulsatile drug delivery system, the composition of which is set forth in Tables 1 and 2. [0080] Appropriate weights of levodopa and carbidopa (weights shown in Tables 1 and 2) are intimately mixed for use in preparing immediate release and controlled release components of the formulations of the present invention. [0081] Immediate-Release Component [0082] The active agents are first mixed with silicon dioxide in a Patterson-Kelley V-blender for 10 minutes. Then microcrystalline cellulose and crosscarmellulose sodium are added and blended for 10 more minutes. Finally, magnesium stearate is added to the blender and mixed for another 10 minutes. The powder blend is then compressed using a Manesty Dry-cota with a 0.2031 inch diameter, round, flat-face punch and die set. The hardness of the tablets is maintained at 4±2 kp. [0083] Immediate-Release Component Plus Controlled-Release Component [0084] The active agents are first mixed with silicon dioxide in a Patterson-Kelley V-blender for 10 minutes. Then hydroxypropyl methylcellulose 2208 and microcrystalline cellulose are added and blended for 10 more minutes. Finally, hydrogenated vegetable oil and magnesium stearate are added to the blender and mixed for another 10 minutes. The core tablets are press-coated using the Manesty Dry-cota with 0.3600″in diameter, round, shallow concave punch and die set. The hardness of the tablets is maintained at 12±4 kp. EXAMPLE 2 [0085] Immediate-Release Component Plus Controlled-Release Component Plus Immediate-Release Component [0086] The method of manufacture for the controlled-release tablets is the same as described in Example 1. The application of the immediate-release component was done by charging the controlled-release tablets into a perforated pan coater or a fluidized particle coater and coating the tablet cores with a solution consisting of levodopa and carbidopa 80% w/ lactose and hydroxypropyl methylcellulose type 2910. TABLE 1 Quantity/Tablet Example #1 Example #2 RT-010 (press- RT-011 (press coated w/o coated w/ immediate- immediate- release coating) release coating) Immediate-Release (IR) Component Levodopa/carbidopa 4:1 ratio 80% w/ 50.0 mg 50.0 mg lactose Croscarmellose sodium 1.6 mg 1.6 mg Microcrystalline cellulose 26.8 mg 26.8 mg Colloidal silicon dioxide 0.8 mg 0.8 mg Magnesium stearate 0.8 mg 0.8 mg Total: 80.0 mg 80.0 mg IR Component Plus Controlled- Release (CR) Component IR Component 80.0 mg 80.0 mg Levodopa/carbidopa 4:1 ratio 80% w/ 37.5 mg 18.8 mg lactose Hydroxypropyl methylcellulose 61.6 mg 61.6 mg type 2208 Microcrystalline cellulose 70.3 mg 89.0 mg Hydrogenated vegetable oil type 1 46.2 mg 46.2 mg Colloidal silicon dioxide 2.2 mg 2.2 mg Magnesium stearate 2.2 mg 2.2 mg Total: 300.0 mg 300.00 mg IR Component Plus CR Component Plus Immediate-Release Component IR Component Plus ER Component 300.0 mg Levodopa/carbidopa 4:1 ratio 80% w/ 18.7 mg lactose Hydroxypropyl methylcellulose 1.9 mg type 2910 Total: 320.6 mg [0087] [0087] TABLE 2 EXCIPIENT RANGE Quantity/tablet Example #1 RT-010 (press coated w/o IR coating) Percent Range Immediate-Release Component Levodopa/carbidopa 4:1 ratio 50.0 mg 62.5% 80% w/lactose Croscarmellose sodium 1.6 mg 2.0%  0.5-10.0% Microcrystalline cellulose 26.8 mg 33.5% 18.0-36.0% Colloidal silicon dioxide 0.8 mg 1.0%  0.5-2.0% Magnesium stearate 0.8 mg 1.0%  0.5-2.0% Total: 80.0 mg Controlled-Release Component Levodopa/carbidopa 4:1 ratio 37.5 mg 17.0% 80% w/lactose Hydroxypropyl methylcellulose 61.6 mg 28.0% 15.0-40.0% type 2208 Microcrystalline cellulose 70.3 mg 32.0%  8.0-57.0% Hydrogenated vegetable oil 46.2 mg 21.0% 10.0-30.0% type 1 Colloidal silicon dioxide 2.2 mg 1.0%  0.5-2.0% Magnesium stearate 2.2 mg 1.0%  0.5-2.0% Total: 220.0 mg EXAMPLE 3 [0088] Example 3 employs the ingredients and amounts listed in Tables 3A, 3B, and 3C below for the formulations PX00502, PX03002, and PX03102, respectively. [0089] For each batch, whether 502, 3002 or 3102, the follows procedure is used: All ingredients, except magnesium stearate are weighed and mixed thoroughly. The mixed ingredients are added to a high shear granulator and mixed for 5 minutes, with an impeller speed of 5 and a chopper speed of 4. Deionized water is employed as the granulating agent. Granules so made are dried in an oven overnight and then screened through a #20 mesh (US standard). Oversize granules are milled, screened with the process repeated until all particles can be screened through a #20 mesh. The magnesium stearate is added to the screened particles and mixed thoroughly. [0090] The resulting mixture can then be used for different types of dosage forms as set out in examples 4 and 5. TABLE 3A per tablet amount PX00502 (w/w) % in mg Carbidopa 18 53.8 Levodopa 67 200.1 Klucel 12.9 38.5 Lake blend 0.3 0.9 Mg stearate 1.8 5.4 Total 100 298.7 [0091] [0091] TABLE 3B per tablet amount PX03002 (w/w) % in mg Carbidopa 11.3 27 Levodopa 41.9 100 Avicel 33.2 79.2 Starch 11.1 26.5 Acdisol 0.8 1.9 Mg stearate 1.7 3.8 Total 100 238.4 [0092] [0092] TABLE 3C per tablet amount PX03102 (w/w) % in mg Carbidopa 9.3 26.9 Levodopa 34.6 100.1 Avicel 27.4 79.3 Starch 27.4 79.3 Mg Stearate 1.3 3.8 Total 100 289.4 [0093] [0093]FIG. 1 shows the dissolution profiles of profiles of carbidopa/levodopa immediate release (IR) 25/100 mg formulations PX03002 and PX03102. As discussed above, all dissolution profiles were carried out by the standard USP paddle method of 50 rpm in 900 ml aqueous buffer at pH 4 at 37° C. [0094] [0094]FIG. 2 shows the dissolution profile of a carbidopa/levodopa controlled release (CR) 50/200 mg formulation PX00502. [0095] [0095]FIG. 3 shows the dissolution profiles of carbidopa/levodopa 75/300 mg formulations PX03602 and PX04002. Note that controlled release (or prolonged release (PR)) tablets PX03602 comprise the combination of PX0502(CR) and PX03102, and PR tablets PX04002 comprise the combination of PX0502(CR) and PX03002. EXAMPLE 4 [0096] The lot 3102 particles produced in Example 3 are segregated into two equal portions of 125 grams each. One portion is coated in a fluidized pan with a mixture of 24.25 g of PVP 29/32, 1000 g of deionized water and isopropyl alcohol (15%), and 0.75 g of triethyl acetate. The particles are dried and thoroughly mixed with the uncoated particles. The particle mixture is then loaded into immediate release gelatin capsules. EXAMPLE 5 [0097] Particles produced according to lots 3002 and 502 of Example 3 are loaded into the two separate hoppers of a dual layer tablet punch. The punch is actuated and two-layer tablets are produced. EXAMPLE 6 [0098] The dissolution summaries for carbidopa/levodopa immediate release (IR) 25/100 mg formulations PX00102, PX02001, and Brand K5370 are shown in Tables 4, 5, and 6, respectively. All data was obtained according to measurements under the USP paddle method of 50 rpm in 900 ml at pH 1.2 (0.1 N HCL) at 37° C. FIG. 4 is a graph of the dissolution profiles of carbidopa/levodopa immediate release (IR) 25/100 mg formulations PX00102, PX02001, and Brand K5370. EXAMPLE 7 [0099] The dissolution summaries for carbidopa/levodopa controlled release (CR) 50/200 mg formulations PX00302, PX00502, and Brand 01023 are shown in Tables 7, 8, and 9, respectively. All data was obtained according to measurements under the USP paddle method of 50 rpm in 900 ml at pH 1.2 (0.1 N HCL) at 37 C. FIG. 5 is a graph of the dissolution of carbidopa/levodopa controlled release (CR) 50/200 mg formulations PX00302, PX00502, and Brand 01023. EXAMPLE 8 [0100] The dissolution summaries for carbidopa/levodopa formulations PX03602 (controlled release, 75/300 mg), PX04002 (controlled release, 75/300 mg), Brand K5370 (immediate release, 25/100 mg), and Brand 01023 (controlled release, 50/200 mg) are shown in Tables 10, 11, 12, and 13, respectively. All data was obtained according to measurements under the USP paddle method of 50 rpm in 900 ml at pH 1.2 (0.1 N HCL) at 37 C. FIG. 6 is a graph of the dissolution profiles of carbidopa/levodopa formulations PX03602 (controlled release, 75/300 mg), PX04002 (controlled release, 75/300 mg), Brand K5370 (immediate release, 25/100 mg), and Brand 01023 (controlled release, 50/200 mg). [0101] As note in Example 3, controlled release (or prolonged release (PR)) tablets PX03602 comprise the combination of PX0502(CR) and PX03102, and PR tablets PX04002 comprise the combination of PX0502(CR) and PX03002. Data For FIG. 4 Levodopa/Carbidopa IR Tablets, 100/25 mg Levodopa Dissolution Summary (n=6) SGF/37° C./50 rpm/Paddle [0102] [0102] TABLE 4 Lot PX00102-100 T = 0 (Ref: F1386, p. 62-67) % Dissolved Range Time (min) V1 V2 V3 V4 V5 V6 V7 V8 V9 V10 V11 V12 Min Max Mean SD 5 88 82 90 83 89 89 85 87 85 85 68 79 68 90 84 6.03 10 96 90 95 91 95 99 94 96 95 99 89 96 89 99 95 3.18 15 98 92 96 93 97 100 96 97 99 101 91 100 91 101 97 3.2 [0103] [0103] TABLE 5 Lot PX02001-100 T = 0 (Ref: F1386, p. 62-67) % Dissolved Range Time (min) V1 V2 V3 V4 V5 V6 V7 V8 V9 V10 V11 V12 Min Max Mean SD 5 87 96 83 95 80 97 87 89 84 82 90 88 80 97 88 5.57 10 98 98 97 101 92 100 98 98 98 93 98 100 92 101 98 2.64 15 100 99 100 103 97 101 100 100 101 97 100 101 97 103 100 1.68 [0104] [0104] TABLE 6 Brand (Sinemet, exp. 02/05) Lot K5370, T = 0 (Ref: F1351, p. 78-82) % Dissolved Range Time (min) V1 V2 V3 V4 V5 V6 V7 V8 V9 V10 V11 V12 Min Max Mean SD 5 92 89 97 97 93 97 94 95 92 99 93 102 89 102 95 3.62 10 99 95 100 100 99 102 101 99 99 101 101 104 95 104 100 2.05 15 100 97 101 101 100 103 102 100 101 101 101 104 97 104 101 1.69 Data For FIG. 5 Levodopa/Carbidopa CR Tablets, 200/50 mg Levodopa Dissolution Summary (n=6) SGF/37° C./50 rpm/Paddle [0105] [0105] TABLE 7 PX00302-100A, T = 0 (Ref: F1351, P. 87-94) % Dissolved Range Time (min) V1 V2 V3 V4 V5 V6 V7 V8 V9 V10 V11 V12 Min Max Mean SD 30 26 26 28 26 25 25 24 26 26 26 26 26 24 28 26 1.07 60 40 39 41 39 37 39 36 38 39 39 39 39 36 41 39 1.21 120 58 62 74 63 56 66 56 57 70 65 58 65 56 74 62 5.87 180 83 90 101 92 75 97 82 87 98 78 93 100 75 101 90 8.82 [0106] [0106] TABLE 8 PX00502-100A, T = 0 (Ref: F1351, P. 87-94) % Dissolved Range Time (min) V1 V2 V3 V4 V5 V6 V7 V8 V9 V10 V11 V12 Min Max Mean SD 30 23 24 24 26 25 24 24 25 25 25 24 24 23 26 24 0.82 60 40 43 43 44 45 42 43 44 43 44 42 42 40 45 43 1.40 120 67 71 70 72 75 68 70 73 71 72 69 69 67 75 71 2.17 180 84 88 88 88 91 84 90 93 89 88 86 88 84 93 88 2.46 [0107] [0107] TABLE 9 Brand 01023, T = 0 (Ref: F1351, P. 83-86) % Dissolved Range Time (min) V1 V2 V3 V4 V5 V6 V7 V8 V9 V10 V11 V12 Min Max Mean SD 30 37 47 42 42 42 34 42 41 30 41 37 34 30 47 39 4.81 60 64 79 71 71 74 59 75 69 53 71 66 60 53 79 68 7.69 120 92 101 99 99 99 93 102 98 84 97 97 93 84 102 96 4.86 180 101 103 103 102 102 105 103 101 103 100 102 104 100 105 102 1.55 Data For FIG. 6 Levodopa/Carbidopa Compositions Drug Release Summary (n=12), SGF/37° C./50 rpm/Paddle [0108] [0108] TABLE 10 (PR, 75/300 mg) PX03602-100, (Ref: PP444, p. 81-87) Range Time (min) V1 V2 V3 V4 V5 V6 V7 V8 V9 V10 V11 V12 Min Max Mean SD 5 34.6 39.9 35.3 33.2 38.0 37.6 42.2 32.1 28.6 33.6 38.3 33.6 29 42 36 3.8 10 39.1 45.0 38.9 36.9 41.3 41.4 47.7 36.7 33.3 37.5 42.4 39.0 33 48 40 3.9 15 42.0 49.0 41.2 39.2 43.5 44.7 51.5 40.1 36.7 40.1 45.3 42.8 37 52 43 4.2 30 48.8 59.0 45.9 44.4 48.4 51.3 60.2 47.8 42.6 46.7 52.5 51.5 43 60 50 5.4 60 55.5 75.9 52.6 51.9 55.6 61.8 72.0 59.4 51.2 56.7 63.2 64.7 51 76 60 7.9 120 65.8 98.9 61.9 62.4 65.5 72.3 82.5 74.7 63.3 70.6 76.9 81.5 62 99 73 10.9 180 73.7 102.2 68.2 69.1 72.1 80.1 88.2 83.6 70.7 79.5 86.9 91.0 68 102 80 10.4 [0109] [0109] TABLE 11 (PR, 75/300 mg) PX04002-100, (Ref: TV490, p. 54-64) Range Time (min) V1 V2 V3 V4 V5 V6 V7 V8 V9 V10 V11 V12 Min Max Mean SD 5 35.1 34.0 27.3 29.2 30.4 24.0 33.7 33.5 36.3 33.8 36.3 35.6 24 36 35 1.3 10 40.6 38.5 32.0 33.8 37.4 29.5 39.8 38.5 42.4 41.8 40.8 41.7 30 42 41 1.5 15 44.2 41.4 35.1 36.8 42.2 32.8 43.9 41.9 46.6 46.9 44.4 46.1 33 47 45 1.9 30 52.3 47.3 41.4 43.2 52.5 39.2 52.6 49.5 56.0 57.7 53.0 55.3 39 58 54 2.9 60 64.7 56.1 51.0 52.7 66.8 48.7 64.9 61.2 70.6 75.0 66.9 69.8 49 75 68 4.8 120 79.3 68.8 64.4 71.4 84.6 63.1 80.4 78.2 89.9 92.0 84.9 88.0 63 92 86 5.4 180 87.1 77.5 73.2 75.4 93.5 72.0 89.0 88.8 96.3 96.2 93.9 94.1 72 96 93 3.4 [0110] [0110] TABLE 12 (IR 25/100 mg) Brand Lot K5370 (Ref: BT476, p. 83-91 & BT497, p. 29-35) % Dissolved Range Time V1 V2 V3 V4 V5 V6 V7 V8 V9 V10 V11 V12 Min Max Mean SD  5 min 100.8 95.9 94.6 99.1 96.5 97.1 97.6 93.0 99.2 100.8 93.7 98.8 93 101 97 2.6 10 min 101.7 99.3 100.3 102.6 100.9 100.9 99.7 98.3 101.9 103.4 98.3 100.5 98 103 101 1.6 15 min 101.6 100.7 100.7 103.1 101.8 101.3 100.7 100.7 102.0 103.6 99.6 100.7 100 104 101 1.1 [0111] [0111] TABLE 13 (SR 50/200 mg) Brand Lot 01023 (Ref: PP496, p. 22-29) Range Time (min) V1 V2 V3 V4 V5 V6 V7 V8 V9 V10 V11 V12 Min Max Mean SD 30 45.9 41.2 36.5 39.0 36.3 35.7 40.5 36.7 36.5 42.5 30.3 30.5 30 46 38 4.6 60 77.2 72.0 62.3 65.9 61.5 60.6 69.7 61.9 62.0 74.7 53.4 54.3 53 77 65 7.5 120 98.9 98.9 91.7 94.1 89.1 88.8 95.7 90.2 89.8 103.9 85.7 85.4 85 104 93 5.7 180 101.3 103.1 101.4 100.8 99.2 98.1 99.2 99.7 99.4 104.6 101.3 99.1 98 105 101 1.9

1a

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation of U.S. application Ser. No. 11/104,720, filed Apr. 13, 2005, which is a continuation of U.S. application Ser. No. 10/668,487, filed Sep. 22, 2003, now U.S. Pat. No. 6,898,452, which is a continuation of U.S. application Ser. No. 10/026,013, filed Dec. 21, 2001, now U.S. Pat. No. 6,714,804, which is a continuation of U.S. application Ser. No. 09/323,176, filed May 27, 1999, now U.S. Pat. No. 6,334,065, which claims priority from U.S. Provisional No. 60/087,802, filed Jun. 3, 1998. BACKGROUND [0002] The measurement of oxygen delivery to the body and the corresponding oxygen consumption by its organs and tissues is vitally important to medical practitioners in the diagnosis and treatment of various medical conditions. Oxygen delivery, the transport of oxygen from the environment to organs and tissues, depends on the orchestration of several interrelated physiologic systems. Oxygen uptake is determined by the amount of oxygen entering the lung and the adequacy of gas exchange within the lung. This gas exchange is determined by the diffusion of oxygen from the alveolar space to the blood of the pulmonary capillaries. Oxygen is subsequently transported to all organs and tissues by blood circulation maintained by the action of the heart. The availability of oxygen to the organs and tissues is determined both by cardiac output and by the oxygen content in the blood. Oxygen content, in turn, is affected by the concentration of available hemoglobin and hemoglobin oxygen saturation. Oxygen consumption is related to oxygen delivery according to Fick's axiom, which states that oxygen consumption in the peripheral tissues is equal to oxygen delivery via the airway. [0003] Oxygen delivery and oxygen consumption can be estimated from a number of measurable parameters. Because of the diagnostic impracticalities of measuring oxygen uptake and cardiac output, oxygen delivery is typically assessed from the oxygen status of arterial blood alone, such as arterial oxygen partial pressure, P a O 2 , and arterial oxygen saturation, S a O 2 . P a O 2 represents the relatively small amount of oxygen dissolved in the blood plasma. S a O 2 represents the much larger amount of oxygen chemically bound to the blood hemoglobin. Oxygen consumption is typically assessed from the oxygen status of mixed venous blood, i.e. the oxygen saturation of blood from the pulmonary artery, S v O 2 , which is used to estimate the O 2 concentration of blood returning from all tissues and organs of the body. These parameters can be measured by both invasive and non-invasive techniques, except S v O 2 , which requires an invasive measurement. [0004] Invasive techniques include blood gas analysis using the in vitro measurement of extracted arterial or venous blood, drawn with a syringe and needle or an intervascular catheter. Arterial blood is commonly obtained by puncturing the brachial, radial or femoral artery. Venous blood can be obtained from an arm vein, but such a sample reflects only local conditions. To obtain mixed venous blood, which represents the composite of all venous blood, a long catheter is typically passed through the right heart and into the main pulmonary artery from a peripheral vein. Extracted blood gas analysis utilizes blood gas machines or oximeters. A blood gas machine measures the partial pressure of oxygen, PO 2 , using a “Clark electrode” that detects the current generated by oxygen diffusing to a sealed platinum electrode across a gas permeable membrane. An oximeter measures the oxygen saturation, SO 2 , of oxygenated and deoxygenated hemoglobin using spectrophotometry techniques that detect the differential absorption of particular wavelengths of light by these blood components. [0005] Invasive monitoring also includes the in vivo monitoring of blood gas via a catheter sensor inserted into an artery or vein. Miniaturization of the Clark electrode allows placement of the electrode in a catheter for continuous measurement of PO 2 . A fiber optic equipped catheter attached to an external oximeter allows continuous measurement of oxygen saturation. Because of risks inherent in catheterization and the promotion of blood coagulation by certain sensors, these techniques are typically only used when vitally indicated. [0006] Non-invasive techniques include pulse oximetry, which allows the continuous in vivo measurement of arterial oxygen saturation and pulse rate in conjunction with the generation of a photoplethsymograph waveform. Measurements rely on sensors which are typically placed on the fingertip of an adult or the foot of an infant. Non-invasive techniques also include transcutaneous monitoring of PO 2 , accomplished with the placement of a heated Clark electrode against the skin surface. These non-invasive oxygen status measurement techniques are described in further detail below. SUMMARY [0007] Prior art invasive oxygen assessment techniques are inherently limited. Specifically, in vitro measurements, that is, blood extraction and subsequent analysis in a blood gas machine or an oximeter, are non-simultaneous and non-continuous. Further, in vivo measurements through catheterization are not casual procedures and are to be particularly avoided with respect to neonates. Prior art noninvasive techniques are also limited. In particular, conventional pulse oximeters are restricted to measurement of arterial oxygen saturation at a single patient site. Also, transcutaneous monitoring is similarly restricted to the measurement of an estimate of arterial partial pressure at a single patient site, among other limitations discussed further below. [0008] The stereo pulse oximeter according to the present invention overcomes many of the limitations of prior art oxygen status measurements. The word “stereo” comes from the Greek word stereos, which means “solid” or three-dimensional. For example, stereophonic systems use two or more channels to more accurately reproduce sound. The stereo pulse oximeter is similarly multi-dimensional, providing simultaneous, continuous, multiple-site and multiple-parameter oxygen status and plethysmograph (photoplethysmograph) measurements. The stereo pulse oximeter provides a benefit in terms of cost and patient comfort and safety over invasive oxygen status estimation techniques. The multi-dimensional aspects of this invention further provide oxygen status and plethysmograph measurements not available from current noninvasive techniques. In addition, the stereo pulse oximeter allows the isolation of noise artifacts, providing more accurate oxygen status and plethysmograph measurements than available from conventional techniques. The result is improved patient outcome based on a more accurate patient assessment and better management of patient care. [0009] In one aspect of the stereo pulse oximeter, data from a single sensor is processed to advantageously provide continuous and simultaneous multiple-parameter oxygen status and plethysmograph measurements from a particular tissue site. This is in contrast to a conventional pulse oximeter that provides only arterial oxygen saturation data from a tissue site. In particular a physiological monitor comprises a sensor interface and a signal processor. The sensor interface is in communication with a peripheral tissue site and has an output responsive to light transmitted through the site. The signal processor is in communication with the sensor interface output and provides a plurality of parameters corresponding to the oxygen status of the site, the plethysmograph features of the site or both. The parameters comprise a first value and a second value related to the peripheral tissue site. In one embodiment, the first value is an arterial oxygen saturation and the second value is a venous oxygen saturation. In this embodiment, another parameter provided may be the difference between arterial oxygen saturation and venous oxygen saturation at the tissue site. The venous oxygen saturation is derived from an active pulse generated at the site. The signal processor output may further comprise a scattering indicator corresponding to the site, and the sensor interface may further comprise a pulser drive, which is responsive to the scattering indicator to control the amplitude of the active pulse. One of the parameter values may also be an indication of perfusion. [0010] In another aspect of the stereo pulse oximeter, data from multiple sensors is processed to advantageously provide continuous and simultaneous oxygen status measurements from several patient tissue sites. This is in contrast to a conventional pulse oximeter that processes data from a single sensor to provide oxygen status at a single tissue site. In particular, a physiological monitor comprises a plurality of sensor interfaces each in communications with one of a plurality of peripheral tissue sites. Each of the sensor interfaces has one of a plurality of outputs responsive to light transmitted through a corresponding one of the tissue sites. A signal processor is in communication with the sensor interface outputs and has a processor output comprising a plurality of parameters corresponding to the oxygen status of the sites, the plethysmograph features of the sites or both. The parameters may comprise a first value relating to a first of the peripheral tissue sites and a second value relating to a second of the peripheral tissue sites. In one embodiment, the first value and the second value are arterial oxygen saturations. In another embodiment, the first value and the second value are plethysmograph waveform phases. The physiological monitor may further comprise a sensor attachable to each of the tissue sites. This sensor comprises a plurality of emitters and a plurality of detectors, where at least one of the emitters and at least one of the detectors is associated with each of the tissue sites. The sensor also comprises a connector in communications with the sensor interfaces. A plurality of signal paths are attached between the emitters and the detectors at one end of the sensor and the connector at the other end of the sensor. [0011] In yet another aspect of the stereo pulse oximeter, data from multiple sensors is processed to advantageously provide a continuous and simultaneous comparison of the oxygen status between several tissue sites. A conventional oximeter, limited to measurements at a single tissue site, cannot provide these cross-site comparisons. In particular a physiological monitoring method comprises the steps of deriving a reference parameter and a test parameter from oxygen status measured from at least one of a plurality of peripheral tissue sites and comparing that reference parameter to the test parameter so as to determine a patient condition. The reference parameter may be a first oxygen saturation value and the test parameter a second oxygen saturation value. In that case, the comparing step computes a delta oxygen saturation value equal to the arithmetic difference between the first oxygen saturation value and the second oxygen saturation value. In one embodiment, the reference parameter is an arterial oxygen saturation measured at a particular one the tissue sites and the test parameter is a venous oxygen saturation measured at that particular site. In another embodiment, the reference parameter is a first arterial oxygen saturation value at a first of the tissue sites, the test parameter is a second arterial oxygen saturation value at a second of the tissue sites. In yet another embodiment, the reference parameter is a plethysmograph feature measured at a first of the sites, the test parameter is a plethysmograph feature measured at a second of the sites and the monitoring method comparison step determines the phase difference between plethysmographs at the first site and the second site. In a further embodiment, the comparing step determines a relative amount of damping between plethysmographs at the first site and the second site. The multi-dimensional features of these embodiments of the stereo pulse oximeter can be advantageously applied to the diagnosis and managed medical treatment of various medical conditions. Particularly advantageous applications of stereo pulse oximetry include oxygen titration during oxygen therapy, nitric oxide titration during therapy for persistent pulmonary hypertension in neonates (PPHN), detection of a patent ductus arteriosis (PDA), and detection of an aortic coarctation. BRIEF DESCRIPTION OF THE DRAWINGS [0012] The present invention will be described in detail below in connection with the following drawing figures in which: [0013] FIG. 1A is a top-level block diagram of a stereo pulse oximeter according to the present invention; [0014] FIG. 1B shows a single-sensor alternative embodiment to FIG. 1A ; [0015] FIG. 2 is a block diagram of the stereo pulse oximeter sensor interface; [0016] FIG. 3 is a graph illustrating the absorption of red and infrared wavelengths by both oxygenated and deoxygenated hemoglobin; [0017] FIG. 4 is a graph showing the empirical relationship between the “red over infrared” ratio and arterial oxygen saturation; [0018] FIG. 5 is a block diagram of the analog signal conditioning for the sensor interface; [0019] FIG. 6 is a functional block diagram of the stereo pulse oximeter signal processing; [0020] FIG. 7 is a functional block diagram of the front-end signal processing; [0021] FIG. 8 is a graph depicting the frequency spectrum of an arterial intensity signal; [0022] FIG. 9 is a graph depicting the frequency spectrum of a combined arterial and venous intensity signal; [0023] FIG. 10 is a functional block diagram of the saturation calculation signal processing; [0024] FIG. 11 is a graph illustrating a plethysmograph waveform; [0025] FIG. 12 is a graph illustrating the absorption contribution of various blood and tissue components; [0026] FIG. 13 is a graph illustrating an intensity “plethysmograph” pulse oximetry waveform; [0027] FIG. 14 is a functional block diagram of the plethysmograph feature extraction signal processing; [0028] FIG. 15 is a functional block diagram of the multiple parameter signal processing; [0029] FIG. 16A is an illustration of a single-site stereo pulse oximeter display screen; [0030] FIG. 16B is an illustration of a multi-site stereo pulse oximeter display screen; [0031] FIG. 17A is a graph depicting a family of constant power curves for the electrical analog of constant oxygen consumption; [0032] FIG. 17B is a graph depicting arterial and venous oxygen saturation versus fractional inspired oxygen; [0033] FIG. 17C is a graph depicting arterial minus venous oxygen saturation versus fractional inspired oxygen; [0034] FIG. 18 is a three-dimensional graph depicting a delta oxygen saturation surface; [0035] FIG. 19 is an illustration of a neonatal heart depicting a pulmonary hypertension condition; [0036] FIG. 20 is an illustration of a fetal heart depicting the ductus arteriosis; and [0037] FIG. 21 is an illustration of a neonatal heart depicting a patent ductus arteriosis (PDA). DETAILED DESCRIPTION [0038] Stereo Pulse Oximetry [0039] FIG. 1A illustrates the multi-dimensional features of a stereo pulse oximeter 100 according to the present invention. Shown in FIG. 1A is an exemplary stereo pulse oximeter configuration in which a first sensor 110 is attached to a neonate's left hand, a second sensor 120 is attached to one of the neonate's feet, and a third sensor 130 is attached to the neonate's right hand. In general, these sensors are used to obtain oxygen status and photoplethysmograph measurements at peripheral sites, including a person's ears and face, such as the nose and regions of the mouth in addition to hands, feet and limbs, but not including internal sites such as internal organs and the brain. [0040] Each sensor 110 , 120 , 130 provides a stream of data through a corresponding sensor interface 114 , 124 , 134 to the digital signal processor (DSP) 150 . For example, the first sensor 110 is connected to an input 112 of the first sensor interface 114 , and the output 118 of the first sensor interface 114 is attached to a first data channel input 152 of the DSP 150 . Similarly, the second sensor 120 provides data to a second data channel input 154 and the third sensor 130 provides data to a third data channel input 158 . [0041] FIG. 1B illustrates an alternative embodiment of the separate sensors 110 , 120 , 130 ( FIG. 1A ). A stereo sensor 140 has multiple branches 112 , 122 , 132 each terminating in a sensor portion 114 , 124 , 134 . Each sensor portion 114 , 124 , 134 has two light emitters and a light detector, as described below, and is attachable to a separate patient site. Thus, the stereo sensor 140 advantageously provides a single sensor device having multiple light emitters and multiple light detectors for attachment to multiple patient tissue sites. A combination of the stereo sensor 140 and a single patient cable 142 advantageously allows a single connection 144 at the stereo pulse oximeter 100 and a single connection 146 at the stereo sensor 140 . [0042] The DSP 150 can independently process each data channel input 152 , 154 , 158 and provide outputs 162 typical of pulse oximetry outputs, such as arterial oxygen saturation, Sp a O 2 , the associated plethysmograph waveform and the derived pulse rate. In contrast with a conventional pulse oximeter, however, these outputs 162 include simultaneous measurements at each of several patient tissue sites. That is, for the configuration of FIG. 1A , the stereo pulse oximeter 100 simultaneously displays Sp a O 2 and an associated plethysmograph waveform for three tissue sites in addition to the patient's pulse rate obtained from any one of sites. Further, the DSP 150 can provide unique outputs unavailable from conventional pulse oximeters. These outputs 164 include venous oxygen saturation, Sp v O 2 , a comparison of arterial and venous oxygen saturation, Δ sat =Sp av O 2 =Sp a O 2 −Sp v O 2 , and pleth, which denotes plethysmograph shape parameters, for each site. In addition, the DSP 150 can provide cross-site outputs that are only available using stereo pulse oximetry. These unique cross-site outputs 168 include Δsat xy =Sp ax O 2 −Sp ay O 2 , which denotes the arterial oxygen saturation at site x minus the arterial oxygen saturation at site y. Also included in these outputs 168 is Δpleth xy , which denotes a comparison of plethysmograph shape parameters measured at site x and site y, as described in detail below. The stereo pulse oximeter also includes a display 180 capable of showing the practitioner the oxygen status and plethysmograph parameters described above. The display 180 has a multiple channel graphical and numerical display capability as described in more detail below. [0043] Pulse Oximetry Sensor [0044] FIG. 2 depicts one stereo pulse oximeter data channel having a sensor 110 and a sensor interface 114 providing a single data channel input 152 to the DSP 150 . The sensor 110 is used to measure the intensity of red and infrared light after transmission through a portion of the body where blood flows close to the surface, such as a fingertip 202 . The sensor 110 has two light emitters, each of which may be, for example, a light-emitting diode (LED). A red emitter 212 , which transmits light centered at a red wavelength and an infrared (IR) emitter 214 , which transmits light centered at an infrared wavelength are placed adjacent to, and illuminate, a tissue site. A detector 218 , which may be a photodiode, is used to detect the intensity of the emitted light after it passes through, and is partially absorbed by, the tissue site. The emitters 212 , 214 and detector 218 are secured to the tissue site, with the emitters 212 , 214 typically spaced on opposite sides of the tissue site from the detector 218 . [0045] To distinguish between tissue absorption at the two wavelengths, the red emitter 212 and infrared emitter 214 are modulated so that only one is emitting light at a given time. In one embodiment, the red emitter 212 is activated for a first quarter cycle and is off for the remaining three-quarters cycle; the infrared emitter 214 is activated for a third quarter cycle and is off for the remaining three-quarters cycle. That is, the emitters 212 , 214 are cycled on and off alternately, in sequence, with each only active for a quarter cycle and with a quarter cycle separating the active times. The detector 218 produces an electrical signal corresponding to the red and infrared light energy attenuated from transmission through the patient tissue site 202 . Because only a single detector 218 is used, it receives both the red and infrared signals to form a time-division-multiplexed (TDM) signal. This TDM signal is coupled to the input 112 of the sensor interface 114 . One of ordinary skill in the art will appreciate alternative activation sequences for the red emitter 212 and infrared emitter 214 within the scope of this invention, each of which provides a time multiplexed signal from the detector 218 allowing separation of red and infrared signals and determination and removal of ambient light levels in downstream signal processing. [0046] To compute Sp a O 2 , pulse oximetry relies on the differential light absorption of oxygenated hemoglobin, HbO 2 , and deoxygenated hemoglobin, Hb, to compute their respective concentrations in the arterial blood. This differential absorption is measured at the red and infrared wavelengths of the sensor 110 . The relationship between arterial oxygen saturation and hemoglobin concentration can be expressed as: Sp a ⁢ O 2 = 100 ⁢ C HbO ⁢   ⁢ 2 C Hb + C HbO ⁢   ⁢ 2 ( 1 ) That is, arterial oxygen saturation is the percentage concentration of oxygenated hemoglobin compared to the total concentration of oxygenated hemoglobin and deoxygenated hemoglobin in the arterial blood. Sp a O 2 is actually a measure of the partial oxygen saturation of the hemoglobin because other hemoglobin derivatives, such as COHb and MetHb, are not taken into consideration. [0047] FIG. 3 shows a graph 300 of the optical absorption properties of HbO 2 and Hb. The graph 300 has an x-axis 310 corresponding to wavelength and a y-axis 320 corresponding to hemoglobin absorption. An Hb curve 330 shows the light absorption properties of deoxygenated hemoglobin. An HbO 2 curve 340 shows the light absorption properties of oxygenated hemoglobin. Pulse oximetry measurements are advantageously made at a red wavelength 350 corresponding to 660 nm and an infrared wavelength 360 corresponding to 905 nm. This graph 300 shows that, at these wavelengths 350 , 360 , deoxygenated hemoglobin absorbs more red light than oxygenated hemoglobin, and, conversely, oxygenated hemoglobin absorbs more infrared light than deoxygenated hemoglobin. [0048] In addition to the differential absorption of hemoglobin derivatives, pulse oximetry relies on the pulsatile nature of arterial blood to differentiate hemoglobin absorption from absorption of other constituents in the surrounding tissues. Light absorption between systole and diastole varies due to the blood volume change from the inflow and outflow of arterial blood at a peripheral tissue site. This tissue site might also comprise skin, muscle, bone, venous blood, fat, pigment, etc., each of which absorbs light. It is assumed that the background absorption due to these surrounding tissues is invariant and can be ignored. Thus, blood oxygen saturation measurements are based upon a ratio of the time-varying or AC portion of the detected red and infrared signals with respect to the time-invariant or DC portion. This AC/DC ratio normalizes the signals and accounts for variations in light pathlengths through the measured tissue. Further, a ratio of the normalized absorption at the red wavelength over the normalized absorption at the infrared wavelength is computed: RD IR = ( Red AC Red DC ) ( IR AC IR DC ) ( 2 ) where Red AC and IR AC are the root-mean-square (RMS) of the corresponding time-varying signals. This “red-over-infrared, ratio-of-ratios” cancels the pulsatile signal. The desired Sp a O 2 measurement is then computed from this ratio. [0049] FIG. 4 shows a graph 400 depicting the relationship between RD/IR and Sp a O 2 . This relationship can be approximated from Beer-Lambert's Law, as outlined below. However, it is most accurately determined by statistical regression of experimental measurements obtained from human volunteers and calibrated measurements of oxygen saturation. The result can be depicted as a curve 410 , with measured values of RD/IR shown on a y-axis 420 and corresponding saturation values shown on an x-axis 430 . In a pulse oximeter device, this empirical relationship can be stored in a read-only memory (ROM) look-up table so that Sp a O 2 can be directly read-out from input RD/IR measurements. [0050] According to the Beer-Lambert law of absorption, the intensity of light transmitted through an absorbing medium is given by: I = I 0 ⁢ exp ⁡ ( - ∑ i = 1 N ⁢ ɛ i ⁢   ⁢ λ ⁢ c i ⁢ x i ) ( 3 ) where I 0 is the intensity of the incident light, ε i,λ . is the absorption coefficient of the i th constituent at a particular wavelength λ, c i is the concentration coefficient of the i th constituent and x i is the optical path length of the i th constituent. As stated above, assuming the absorption contribution by all constituents but the arterial blood is constant, taking the natural logarithm of both sides of equation (3) and removing time invariant terms yields: ln( l )=−[ε HbO2,λ C HbO2 +ε Hb,λ C hb ]x ( t )  (4) Measurements taken at both red and infrared wavelengths yield: RD( t )=−[ε HbO2,RD C HbO2 +ε Hb,RD C hb ]x RD   ( t )  ( 5 ) IR( t )=−[ε HbO2,IR C HbO2 +ε Hb,IR C hb ]x IR ( t )  (6) Taking the ratio RD(t)/IR(t) and assuming x RD (t)≈x IR (t) yields: RD/IR=[ε HbO2,RD C HbO2 +ε Hb,RD C Hb ]/[ε HbO2,IR C HbO2 +ε Hb,IR C hb ]  (7) Assuming further that: C HbO2 +C Hb =1  (8) then equation (1) can be solved in terms of RD/IR yielding a curve similar to the graph 400 of FIG. 4 . [0051] Sensor Interface [0052] FIG. 2 also depicts the sensor interface 114 for one data channel. An interface input 112 from the sensor 110 is coupled to an analog signal conditioner 220 . The analog signal conditioner 220 has an output 223 coupled to an analog-to-digital converter (ADC) 230 . The ADC output 118 is coupled to the DSP 150 . The analog signal conditioner also has a gain control input 225 from the DSP 150 . The functions of the analog signal conditioner 220 are explained in detail below. The ADC 230 functions to digitize the input signal 112 prior to further processing by the DSP 150 , as described below. The sensor interface 114 also has an emitter current control input 241 coupled to a digital-to-analog converter (DAC) 240 . The DSP provides control information to the DAC 240 via the control input 241 for a pair of emitter current drivers 250 . One driver output 252 couples to the red emitter 212 of the sensor 110 , and another driver output 254 couples to the IR emitter 214 of the sensor 110 . [0053] FIG. 5 illustrates one embodiment of the analog signal conditioner 220 . The analog signal conditioner 220 receives a composite intensity signal 112 from the sensor detector 218 ( FIG. 2 ) and then filters and conditions this signal prior to digitization. The embodiment shown has a preamplifier 510 , a high pass filter 520 , a programmable gain amplifier 530 and a low pass filter 540 . The low pass filter output 223 is coupled to the ADC 230 ( FIG. 2 ). The preamplifier 510 converts the current signal 112 from the detector 218 ( FIG. 2 ) to a corresponding amplified voltage signal. The gain in the preamplifier 510 is selected in order to prevent ambient light in the signal 112 from saturating the preamplifier 510 under normal operating conditions. The preamplifier output 512 is coupled to the high pass filter 520 , which removes the DC component of the detector signal 112 . The corner frequency of the high pass filter 520 is set well below the multiplexing frequency of the red and infrared emitters 212 , 214 ( FIG. 2 ). The high pass filter output 522 couples to the programmable gain amplifier 530 , which also accepts a programming input 225 from the DSP 150 ( FIG. 2 ). This gain is set at initialization or at sensor placement to compensate for variations from patient to patient. The programmable gain amplifier output 532 couples to a low-pass filter 540 to provide anti-aliasing prior to digitization. [0054] As described above, pulse oximetry measurements rely on the existence of a pulsatile signal. The natural heart beat provides a pulsatile signal that allows measurement of arterial oxygen saturation. In the systemic circulation, all arterial pulsations are damped before flow enters the capillaries, and none are transmitted into the veins. Thus, there is no arterial pulse component in the venous blood and absorption caused by venous blood is assumed canceled by the ratio-of-ratio operation described above. Venous blood, being at a relatively low pressure, will “slosh back and forth” during routine patient motions, such as shivering, waving and tapping. This venous blood sloshing creates a time-varying signal that is considered “noise” and can easily overwhelm conventional ratio-based pulse oximeters. Advanced pulse oximetry techniques allow measurement of Sp v O 2 under these circumstances. For example, such advanced techniques are disclosed in U.S. Pat. No. 5,632,272, which is assigned to the assignee of the current application. This measurement is only available during motion or other physiological events causing a time-varying venous signal. [0055] The venous blood may also have a pulsatile component at the respiration rate, which can be naturally induced or ventilator induced. In adults, the natural respiration rate is 10-15 beats per minute (bpm). In neonates, this natural respiration rate is 30-60 bpm. The ventilator induced pulse rate depends on the ventilator frequency. If this respiration induced venous pulse is of sufficient magnitude, advanced pulse oximetry techniques, described below, allow measurement of Sp v O 2 . [0056] A controlled physiological event, however, can be created that allows for a continuous measurement of venous oxygen saturation, independent of motion or respiration. U.S. Pat. No. 5,638,816, which is assigned to the assignee of the current application discloses a technique for inducing an intentional active perturbation of the blood volume of a patient, and is referred to as an “active pulse.” Because peripheral venous oxygen saturation, Sp v O 2 , is a desirable parameter for stereo pulse oximetry applications, it is advantageous to provide for a continuous and controlled pulsatile venous signal. [0057] FIG. 2 depicts an active pulse mechanism used in conjunction with a pulse oximetry sensor. An active pulser 260 physically squeezes or otherwise perturbs a portion of patient tissue 270 in order to periodically induce a “pulse” in the blood at the tissue site 202 . A pulser drive 280 generates a periodic electrical signal to a transducer 262 attached to the patient. The transducer 262 creates a mechanical force against the patient tissue 270 . For example, the pulser 260 could be a solenoid type device with a plunger that presses against the fleshy tissue to which it is attached. The DSP 150 provides pulse drive control information to a digital to analog converter (DAC) 290 via the control input 291 . The DAC output 292 is coupled to the pulser drive 280 . This allows the processor to advantageously control the magnitude of the induced pulse, which moderates scattering as described below. The pulser 260 could be a pressure device as described above. Other pressure mechanisms, for example a pressure cuff, could be similarly utilized. Other methods, such as temperature fluctuations or other physiological changes, which physiologically alter a fleshy medium of the body on a periodic basis to modulate blood volume at a nearby tissue site could also be used. Regardless of the active pulse mechanism, this modulated blood volume is radiated by a pulse oximeter sensor and the resulting signal is processed by the signal processing apparatus described below to yield Sp v O 2 . [0058] Signal Processor [0059] FIG. 6 illustrates the processing functions of the digital signal processor (DSP) 150 ( FIG. 1A ). Each data channel input 152 , 154 , 158 ( FIG. 1A ) is operated on by one or more of the front-end processor 610 , saturation calculator 620 , plethysmograph feature extractor 630 and multiple parameter processor 640 functions of the DSP 150 . First, a digitized signal output from the ADC 230 ( FIG. 2 ) is input 602 to the front-end processor 610 , which demultiplexes, filters, normalizes and frequency transforms the signal, as described further below. A front-end output 612 provides a red signal spectrum and an IR signal spectrum for each data channel as inputs to the saturation calculator 620 . Another front-end output 614 provides a demultiplexed, normalized IR plethysmograph for each data channel as an input to the feature extractor 630 . The saturation calculator output 622 provides arterial and venous saturation data for each data channel as input to the multiple parameter processor 640 . One feature extractor output 632 provides data on various plethysmograph shape parameters for each data channel as input into the multiple parameter processor 640 . Another feature extractor output 634 , also coupled to multiple parameter processor 640 , provides an indication of plethysmograph quality and acts as a threshold for determining whether to ignore portions of the input signal 602 . The multiple parameter processor has a numerical output 642 that provides same-channel Δsat parameters and cross-channel parameters, such as Δsat xy or Δpleth xy to a display 180 ( FIG. 1A ). The numeric output 642 may also provide saturation and plethysmograph parameters directly from the saturation calculator 620 or the feature extractor 630 without further processing other than data buffering. The multiple parameter processor also has a graphical output 644 that provides plethysmograph waveforms for each data channel in addition to graphics, depending on a particular application, the indicate the trend of the numerical parameters described above. [0060] Front-End Processor [0061] FIG. 7 is a functional block diagram of the front-end processor 610 for the stereo pulse oximeter. The digitized sensor output 118 ( FIG. 2 ) is an input signal 602 to a demultiplexer 710 , which separates the input signal 602 into a red signal 712 and an infrared signal 714 . The separated red and infrared signals 712 , 714 are each input to a filter 720 to remove unwanted artifacts introduced by the demultiplexing operation. In one embodiment, the filter 720 is a finite-impulse-response, low-pass filter that also “decimates” or reduces the sample rate of the red and infrared signals 712 , 714 . The filtered signals 722 are then each normalized by a series combination of a log function 730 and bandpass filter 740 . The normalized signals, RD(t), IR(t) 742 are coupled to a Fourier transform 750 , which provides red frequency spectrum and infrared frequency spectrum outputs, RD(ω), IR(ω) 612 . A demultiplexed infrared signal output 614 is also provided. [0062] Saturation Calculator [0063] FIG. 8 shows a graph 800 illustrating idealized spectrums of RD(t) and IR(t) 752 ( FIG. 7 ). The graph has an x-axis 810 that corresponds to the frequency of spectral components in these signals and a y-axis 820 that corresponds to the magnitude of the spectral components. The spectral components are the frequency content of RD(t) and IR(t), which are plethysmograph signals corresponding to the patient's pulsatile blood flow, as described below. Thus, the frequencies shown along the x-axis 810 , i.e. f 0 , f 1 , f 2 , are the fundamental and harmonics of the patient's pulse rate. The spectrum of RD(t), denoted RD(ω) 612 ( FIG. 7 ), is shown as a series of peaks, comprising a first peak 832 at a fundamental frequency, f 0 , a second peak 842 at a first harmonic, f 1 and a third peak 852 at a second harmonic, f 2 . Similarly, the spectrum of IR(t), denoted IR(ω) 612 ( FIG. 7 ), is shown as another series of peaks, comprising a first peak 834 at a fundamental frequency, f 0 , a second peak 844 at a first harmonic, f 1 and a third peak 854 at a second harmonic, f 2 . Also shown in FIG. 8 is the ratio of the spectral peaks of RD(t) and IR(t), denoted RD(ω)/IR(ω). This ratio is shown as a first ratio line 838 at the fundamental frequency f 0 , a second ratio line 848 at the first harmonic f 1 , and a third ratio line 858 at the second harmonic f 2 . [0064] The magnitude of these ratio lines RD(ω)/IR(ω) corresponds to the ratio RD/IR defined by equation (2), and, hence, can be used to determine Sp a O 2 . This can be seen from Parseval's relation for a periodic signal, x(t), having a period T, where X k is the spectral component at the kth harmonic of x(t): 1 T ⁢ ∫ 0 T ⁢ (  x ⁡ ( t )  ) 2 ⁢ ⅆ t = ∑   ⁢ k   ⁢   ⁢ (  X k ⁢    ) 2 ( 9 ) Equation (9) relates the energy in one period of the signal x(t) to the sum of the squared magnitudes of the spectral components. The term |X k | 2 can be interpreted as that part of the energy per period contributed by the kth harmonic. In an ideal measurement, the red and infrared signals are the same to within a constant scale factor, which corresponds to the arterial oxygen saturation. Likewise, the red and infrared spectra are also the same to within a constant scale factor. Thus, in an ideal measurement, all of the ratio lines 838 , 848 , 858 have substantially the same amplitude. Any differences in the amplitude of the ratio lines is likely due to motion, scattering or other noise contaminations, as discussed further below. Accordingly, any of the RD(ω)/IR(ω) ratio lines is equivalent to the ratio, RD/IR, of equation (2) and can be used to derive Sp a O 2 . [0065] One skilled in the art will recognize that the representations in FIG. 8 are idealized. In particular, in actual measured data, especially if contaminated by noise, the frequencies of the peaks of RD(ω) do not correspond exactly to the frequencies of the peaks of IR(ω). For example, the fundamental frequency, f 0 , found for RD(ω) will often be different from the fundamental frequency, f 0 ′, found for IR(ω) and similarly for the harmonics of f 0 . [0066] FIG. 9 shows a graph 900 illustrating idealized spectrums RD(ω) and IR(ω) and associated ratio lines measured with an active pulse sensor. The graph 900 has an x-axis 910 that corresponds to the frequency of spectral components in these signals and a y-axis 920 that corresponds to the magnitude of the spectral components. The spectrum, RD(ω), is shown as two series of peaks. One series of peaks 930 occurs at a fundamental frequency, f h0 , and associated harmonics, f h1 and f h2 , of the patient's pulse (heart) rate. Another series of peaks 940 occurs at a fundamental frequency, f p0 , and associated harmonics, f p1 and f p2 , Of the active pulse rate. Similarly, the spectrum, IR(ω), is shown as two series of peaks. One series of peaks 950 occurs at a fundamental frequency, f h0 , and associated harmonics, f h1 and f h2 , of the patient's pulse rate. Another series of peaks 960 occurs at a fundamental frequency, f p0 , and associated harmonics, f p1 and f p2 , of the active pulse rate. Accordingly, there are two series of RD/IR ratio lines. One series of ratio lines 970 are at the patient's pulse rate and associated harmonics, and another series of ratio lines 980 are at the active pulser rate and associated harmonics. [0067] Because only the arterial blood is pulsatile at the patient's pulse rate, the ratio lines 970 are only a function of the arterial oxygen saturation. Accordingly, Sp a O 2 can be derived from the magnitude of these ratio lines 970 , as described above. Further, a modulation level for the active pulse is selected which insignificantly perturbates the arterial blood while providing a measurable venous signal. This is possible because the arterial blood pressure is significantly larger than the venous pressure. The modulation level is regulated as described above with respect to FIG. 2 , i.e. the DSP 150 , via a pulser drive control 291 , sets the magnitude of the pulser drive 280 to the pulse inducing mechanism 262 . Assuming that the active pulse modulation of the arterial blood is insignificant, only the venous blood is pulsatile at the active pulser rate. Hence, the ratio lines 980 are only a function of the venous oxygen saturation. Accordingly, Sp a O 2 can be derived from the magnitude of the pulse rate related ratio lines 980 in the same manner as Sp a O 2 is derived from the magnitude of the pulse rate related ratio lines. [0068] Scattering [0069] Propagation of optical radiation through tissue is affected by absorption and scattering processes. The operation of pulse oximeters was described qualitatively above using an analysis based on the Beer-Lambert law of absorption, equation (3). This approach, however, fails to account for the secondary effects of light scattering at pulse oximeter wavelengths. The primary light scatterer in blood is erythrocytes, i.e. red blood cells. A qualitative understanding of the effects of scattering on pulse oximetry is aided by a description of red blood cell properties within flowing blood. [0070] Human blood is a suspension of cells in an aqueous solution. The cellular contents are essentially all red blood cells, with white cells making up less the 1/600 th of the total cellular volume and platelets less than 1/800 th of the total cellular volume. Normally the hematocrit, which is the percentage of the total volume of blood occupied by cells, is about 50% in large vessels and 25% in small arterioles or venules. [0071] Red blood cells are extremely deformable, taking on various shapes in response to the hydrodynamic stresses created by flowing blood. For example, assuming a laminar blood flow within a vessel, a parabolic velocity profile exists that is greatest in the vessel center and smallest along the vessel walls. Nominally, red blood cells are shaped as biconcave disks with a diameter of 7.6 um and thickness of 2.8 um. Exposed to this velocity profile, the red blood cells become parachute-shaped and aligned in the direction of the blood flow. Thus, during systole, transmitted light is scattered by aligned, parachute-shaped cells. During diastole, the light is scattered by biconcave disks having a more or less random alignment. [0072] The time-varying shape and alignment of the red blood cells can have a significant effect on measured values of oxygen saturation if scattering is ignored. Analogous to the analysis using the Beer-Lambert absorption law, scattering can be qualitatively understood as a function of the scattering coefficients of various tissues. Specifically, the bulk scattering coefficient can be written as: μ s =V b μ b +V t μ t   (10) where V b is the blood volume, .μ b is the scattering coefficient of blood, V t is the surrounding tissue volume and .μ t is the scattering coefficient of the surrounding tissue. The volume, V t , and scattering coefficient, μ t , of the surrounding tissue are time invariant. The blood volume, V b , however, is pulsatile. The ratio of ratios computation, RD/IR, results in normalization of the time invariant or DC tissue absorption and cancellation of the time varying or AC pulsatile blood volume absorption to yield a number related to oxygen saturation. This computational approach is valid because the absorption coefficients of blood, ε HbO2,λ , ε Hb,λ given in equation (4) were assumed to change only slowly over time. The scattering coefficient of blood .μ b , however, is time variant. As described above, this variation is due to the time-varying alignment and shape of the red blood cells. This time variation in the detected intensity of light transmitted through a tissue site is not normalized or canceled by the RD/IR calculation. Further, because the magnitude of the scattering coefficient variations is a function of blood flow, these variations become more pronounced with larger pulses in the blood supply. As a result, scattering produces frequency-dependent magnitude variations in the ratio lines RD(ω)/IR(ω). [0073] FIG. 9 illustrates the effect of scattering on the spectra of the detected red and infrared intensity waveforms. When these waveforms are transformed into the frequency domain, the time varying component of scattering manifests itself as spreads 978 , 988 in the RD/IR ratio lines at each harmonic of the plethysmograph or active pulse rate. The magnitude of the ratio lines 970 at the fundamental and harmonics of the patient's pulse rate varies between a minimum 972 and a maximum 974 , resulting in a magnitude spread 978 . Similarly, the magnitude of the ratio lines 980 at the fundamental and harmonics of the active pulse rate varies between a minimum 982 and a maximum 984 , resulting in a magnitude spread 988 . Normally, absent motion artifact or noise contamination, the spread 978 , 988 in the ratio lines is quiet small, but the magnitude of these spreads 978 , 988 , increases with larger blood flows or pulse magnitudes. Scattering attributable to an active pulse can be regulated by adjusting the magnitude of the active pulse modulation based upon the amount of spread 978 , 988 of the ratio line magnitudes. Thus, the active pulse magnitude can be increased to obtain a larger detected AC signal, but limited to below the point at which scattering becomes significant. [0074] FIG. 10 depicts an embodiment of the signal processing for determining oxygen saturation from the ratio lines of RD(ω)/RD(ω). The red spectrum RD(ω) 612 and infrared spectrum IR(ω) 612 , computed as described above with respect to FIG. 7 , are input to a peak detector 1010 . The peak detector 1010 separately calculates localized maximums for RD(ω) and IR(ω). The peak detector output 1012 is a series of frequencies corresponding to the patient pulse rate fundamental and harmonics. If an active pulse is used, the peak detector output 1012 is also a series of frequencies corresponding to the active pulse rate. Although the active pulse rate is known, the detected peaks may have been shifted due to noise, motion artifact or other signal contamination. The peak detector output 1012 is coupled to a series combination of peak matcher 1020 and ratio line calculator 1030 . The ratio lines RD/IR are calculated by matching the frequency peaks of RD(ω) with the nearest frequency peaks of IR(ω). The ratio lines associated with the pulse rate harmonics 1032 are then separated into a different set from the ratio lines associated with the active pulse harmonics 1034 , assuming an active pulse is utilized. An average ratio line for each set 1032 , 1034 is calculated by averaging 1060 all ratio lines in a set. The magnitude of the average ratio line r 1062 for the pulse rate set 1032 is then fed to a look-up table (LUT) 1090 , which provides an output 622 of the measured value of Sp a O 2 . Similarly, if an active pulse is used, the magnitude of the average ratio line μ 1064 for the active pulse rate set 1034 is then fed to a LUT 1090 , which provides an output 622 of the measured value of Sp v O 2 . A scattering detector 1080 computes the spread 988 ( FIG. 9 ) in the set of ratio lines associated with the active pulse and provides this value 1082 to the DSP 150 ( FIG. 2 ) so that the DSP can set the pulser drive control 291 ( FIG. 2 ) to regulate the magnitude of the active pulse. [0075] Alternatively, Sp v O 2 may be measured from respiration-induced pulses in the venous blood, described above, without utilizing an active pulse sensor. Specifically, a series of ratio lines 980 ( FIG. 9 ) would occur at a fundamental frequency, f r0 , and associated harmonics, f r1 and f r2 , of the respiration rate, which is either known from the ventilator frequency or derived from a separate measurement of the natural respiration. As shown in FIG. 10 , the ratio lines associated with the respiration rate harmonics 1034 are then separated into a different set from the ratio lines associated with the pulse rate harmonics 1032 . An average ratio line for the respiration rate set 1034 is calculated by averaging 1060 all ratio lines in that set. The magnitude of the average ratio line μ 1064 for the respiration rate set 1034 is then fed to a look-up table (LUT) 1090 , which provides an output 622 of the measured value of Sp v O 2 . [0076] Plethysmograph Feature Extractor [0077] FIG. 11 illustrates the standard plethysmograph waveform 1100 , which can be derived from a pulse oximeter. The waveform 1100 is a visualization of blood volume change in the illuminated peripheral tissue caused by arterial blood flow, shown along the y-axis 1110 , over time, shown along the x-axis 1120 . The shape of the plethysmograph waveform 1100 is a function of heart stroke volume, pressure gradient, arterial elasticity and peripheral resistance. The ideal waveform 1100 displays a broad peripheral flow curve, with a short, steep inflow phase 1130 followed by a 3 to 4 times longer outflow phase 1140 . The inflow phase 1130 is the result of tissue distention by the rapid blood volume inflow during ventricular systole. During the outflow phase 1140 , blood flow continues into the vascular bed during diastole. The end diastolic baseline 1150 indicates the minimum basal tissue perfusion. During the outflow phase 1140 is a dicrotic notch 1160 , the nature of which is disputed. Classically, the dicrotic notch 1160 is attributed to closure of the aortic valve at the end of ventricular systole. However, it may also be the result of reflection from the periphery of an initial, fast propagating, pressure pulse that occurs upon the opening of the aortic valve and that precedes the arterial flow wave. A double dicrotic notch can sometimes be observed, although its explanation is obscure, possibly the result of reflections reaching the sensor at different times. [0078] FIG. 12 is a graph 1200 illustrating the absorption of light at a tissue site illuminated by a pulse oximetry sensor. The graph 1200 has a y-axis 1210 representing the total amount of light absorbed the tissue site, with time shown along an x-axis 1220 . The total absorption is represented by layers including the static absorption layers due to tissue 1230 , venous blood 1240 and a baseline of arterial blood 1250 . Also shown is a variable absorption layer due to the pulse-added volume of arterial blood 1260 . The profile 1270 of the pulse-added arterial blood 1260 is seen as the plethysmograph waveform 1100 depicted in FIG. 11 . [0079] FIG. 13 illustrates the photoplethysmograph intensity signal 1300 detected by a pulse oximeter sensor. A pulse oximeter does not directly detect absorption, and hence does not directly measure the standard plethysmograph waveform 1100 ( FIG. 11 ). However, the standard plethysmograph can be derived by observing that the detected intensity signal 1300 is merely an out of phase version of the absorption profile 1270 . That is, the peak detected intensity 1372 occurs at minimum absorption 1272 ( FIG. 12 ), and minimum detected intensity 1374 occurs at maximum absorption 1274 ( FIG. 12 ). Further, a rapid rise in absorption 1276 ( FIG. 12 ) during the inflow phase of the plethysmograph is reflected in a rapid decline 1376 in intensity, and the gradual decline 1278 ( FIG. 12 ) in absorption during the outflow phase of the plethysmograph is reflected in a gradual increase 1378 in detected intensity. [0080] FIG. 14 illustrates the digital signal processing for plethysmograph feature extraction 630 ( FIG. 6 ). The input 614 is the IR signal output from the demultiplexer 710 ( FIG. 7 ). This signal is shifted into a first-in, first-out (FIFO) buffer, which allows fixed-length portions of the input signal 614 to be processed for feature extraction. The buffered output signal 1412 is coupled to a shape detector 1420 , slope calculator 1430 , feature width calculator 1440 and a notch locator 1450 , which perform the core feature extraction functions. The shape detector 1420 determines if a particular buffered signal portion 1412 contains specific gross features, such as a peak, a valley, an upward slope, a downward slope, a dicrotic notch or a multiple dicrotic notch. A detected shape output 1422 containing one or more flags indicating the gross feature content of the current signal portion 1412 is coupled to the other feature extraction functions 1430 , 1440 , 1450 and to the waveform quality determination functions 1460 , 1470 , 1480 . A slope calculator 1430 determines the amount of positive or negative slope in the signal portion 1412 if the shape detector output 1422 indicates a slope is present. The output slope value 1432 is coupled to the waveform quality functions 1460 , 1470 , 1480 in addition to the feature extraction output 632 . A feature calculator 1440 quantifies a feature in one or more signal portions 1412 specified by the shape detector 1420 , such as the magnitude, the area under, or the width of a peak or notch. The feature calculator output 1442 is a code indicating the feature and its value, which is coupled to the feature extraction output 632 . A feature locator 1450 quantifies the time of occurrence of one or more features of a signal portion 1412 as specified by the shape detector 1420 . The feature locator output 1452 , which is coupled to the feature extraction output 632 , is a code indicating a feature and an associated code indicating time of occurrence in reference to a particular epoch. The feature locator output 1452 allows a determination of the relative location of plethysmograph features in addition to a phase comparison of plethysmographs derived from two or more tissue sites. Another feature extraction output 634 , which is coupled to the multiple parameter processor 640 ( FIG. 6 ), provides an indication of waveform quality. Input signals portions 1412 not having either a sharp downward edge 1460 , a symmetrical peak 1470 or a gradual decline 1480 are not processed further. [0081] Multiple Parameter Processor [0082] FIG. 15 illustrates the multiple parameter processing portion 640 ( FIG. 6 ) of the signal processing. A differencing function 1510 has as inputs a first saturation value, Sp 1 O 2 , and a second saturation value, Sp 2 O 2 , 622 . The saturation input values 622 can be arterial and venous saturation values from a single data channel, arterial saturation values from two different data channels or venous saturation values from two different data channels. The differences of the saturation value inputs 622 are provided as an output 1514 , which is coupled to a saturation data memory 1520 . The saturation values 622 are also directly coupled to the saturation data memory 1520 . The memory 1520 stores a record of saturation values, SpO 2 , for each channel, delta saturation values, Δsat, for each channel and cross-channel delta saturation values, Δsat xy , as required for a particular application. A flow calculator 1530 utilizes a plethysmograph input 614 or a bio-impedance probe input 1534 to provide a flow value 1538 , which is also coupled to the saturation data memory 1520 . For example, the flow value 1538 may be a perfusion index, PI, defined as follows: PI = IR max - IR min IR DC ( 11 ) where IR max is the maximum value, IR min is the minimum value, and IR DC is the average value of the IR plethysmograph signal 614 ( FIG. 7 ). [0083] The saturation data memory 1520 provides a buffered output 1522 that is coupled to a numerical display driver 1540 . The numerical display driver 1540 provides an output 642 to a standard display, such as LED or LCD numerical display modules or a CRT monitor. The memory output 1522 is also coupled to a saturation data analyzer 1530 , one function of which calculates a long-term trend of the values in memory 1520 . For example, the saturation data analyzer may average a saturation value over time, or provide samples of the saturation values taken at regular time intervals. The output 1532 can either be numerical, which is coupled to the numerical display driver 1540 , or graphical, which is coupled to the graphical display driver 1570 . The graphical display driver 1570 provides an output 644 to a standard graphical display device, such as LED or LCD graphical display modules or a CRT monitor. [0084] A pleth data memory 1550 has as inputs the IR plethysmograph signals 614 ( FIG. 7 ) from each data channel and the associated extracted features 632 ( FIG. 14 ). The memory 1550 also has an input indicating waveform quality 634 ( FIG. 14 ). The pleth memory 1550 provides a buffered output 1558 that is coupled to the graphical display driver 1570 , allowing display of the plethysmograph waveforms for each data channel. The memory output 1558 is also coupled to a pleth data analyzer 1560 , one function of which calculates a long-term trend of the plethysmograph and shape parameters in pleth memory 1520 . For example, the pleth data analyzer 1560 may provide an average of particular shape parameters over time. As another example, the pleth data analyzer 1560 may provide a graphic showing an accumulation of many overlaid plethysmographs. The output 1562 can either be numerical, which is coupled to the numerical display driver 1540 , or graphical, which is coupled to the graphical display driver 1570 . [0085] Another function of the saturation data analyzer 1530 and the pleth data analyzer 1560 is to compare oxygen status and plethysmograph parameters derived from multiple sites in order to isolate noise artifacts and to derive a more accurate estimate of these parameters. For example, it is unlikely that motion artifact will affect each peripheral site in the same manner. If the quality input 634 indicates a noisy plethysmograph for one channel during a particular time period, the pleth data analyzer 1560 can exchange this information 1565 with the saturation data analyzer 1530 . The saturation data analyzer 1530 can then ignore the saturation data for that channel for that time period in lieu of saturation data from another channel. In a similar fashion, noisy data from multiple channels can be averaged, correlated or otherwise processed to provide an estimate of Sp a O 2 , Sp v O 2 or pulse rate, or to provide a plethysmograph that is more accurate than can be derived from a single data channel. [0086] FIG. 16A illustrates detail of a single-site display screen 180 for the stereo pulse oximeter. The display has a numerical display portion 1610 controlled by the numerical display driver 1540 ( FIG. 15 ) and a graphical display portion 1660 controlled by the graphical display driver 1570 ( FIG. 15 ). The numerical display portion 1610 displays a value for Sp a O 2 1620 , Sp v O 2 1630 and pulse rate 1640 for a particular tissue site. The graphical display portion 1660 displays a plethysmograph 1662 for the corresponding tissue site, which can be displayed as a single waveform or an accumulated multiple of overlayed waveforms that may reveal a waveform trend. A push button or menu selection allows the user to switch to a display of data from any single one of the multiple tissue sites to which a sensor is attached. [0087] FIG. 16B illustrates detail of a multi-site display screen 180 for the stereo pulse oximeter. The numerical display portion 1610 displays a value for Sp a O 2 1622 and Sp v O 2 1632 for a first tissue site. Also displayed is a value for Sp a O 2 1624 and Sp v O 2 1634 for a second tissue site. In addition, a value for pulse rate 1642 derived from either the first or second tissue site, or both, is displayed. The graphical display portion 1660 displays a first plethysmograph 1664 and a second plethysmograph 1666 corresponding to the first and second tissue sites, respectively. A push button, menu selection allows the user to manually switch between the single site display ( FIG. 16A ) and the multi-site display ( FIG. 16B ). Also, a triggering event, such as an alarm based on multiple-site oxygen status parameters, causes the display to automatically switch from the single-site display to the multi-site display, enabling the user better view the conditions that caused the triggering event. [0088] One of ordinary skill will appreciate many display screens variations from those shown in FIGS. 16A and 16B that are within the scope of this invention. For example, the stereo pulse oximeter could be configured to provide several push button or menu selectable display screens. One display screen might display more than two channels of oxygen status data. Another display screen could display cross-channel parameters such as Δsat xy or a comparison of plethysmograph shape parameters from two channels. One of ordinary skill will also appreciate many variations and modifications of layout and design for the graphical and numerical displays within the scope of this invention. [0089] Stereo Pulse Oximetry Applications [0090] Oxygen Titration [0091] Oxygen is one of the most commonly used drugs in an intensive care unit and is an integral part of all respiratory support. The goal of oxygen therapy is to achieve adequate delivery of oxygen to the tissues without creating oxygen toxicity. Too little oxygen results in organ damage and, in particular, brain damage. Too much oxygen can result in, for example, pulmonary edema and, in neonates, retinopathy of prematurity (ROP). Infants receiving oxygen therapy, in particular, must have inspired oxygen concentration and blood oxygen levels monitored closely. [0092] Oxygen titration in neonates is currently accomplished with either transcutaneous monitoring or monitoring with a conventional pulse oximeter. As mentioned above, transcutaneous monitoring involves the placement of a heated Clark electrode against the skin surface. The electrode is secured to the skin surface with an airtight seal to eliminate contamination by room air gases. The skin surface beneath the electrode is then heated, which opens pre-capillary sphincters allowing localized arteriolar blood flow beneath the sensor. The so-called T c O 2 value that is measured correlates well with P a O 2 . However, there are several drawbacks to this approach. Because the skin surface must be heated, a fifteen minute elapsed time after application is necessary before stable readings are acquired. Further, the required temperature is 43-45° C. (110° F.), with an associated risk of burns. In addition, titration is often accomplished by simply maintaining T c O 2 within acceptable limits for this parameter, e.g. an equivalent P a O 2 of 50-80 mm Hg for neonates. However, P a O 2 alone does not provide an indication of balance between inspired oxygen and the rate of tissue oxygen consumption. If the patient is particularly anemic or hypovolemic, has an abnormal hemoglobin, or a small cardiac output, then oxygen delivery may be inadequate even in the presence of a normal P a O 2 . Titration with a conventional pulse oximeter is similarly accomplished by maintaining Sp a O 2 within acceptable limits, which also fails to consider tissue oxygen consumption. [0093] Oxygen titration can be more adequately monitored with a continuous indication of oxygen consumption, which is equal to oxygen delivery according to Fick's algorithm, as noted above. Further, continuous monitoring of oxygen consumption at a peripheral tissue site, although not necessarily indicative of overall oxygen consumption, may be indicative of an oxygen supply dependency. A measure of peripheral oxygen consumption can be expressed in terms of Δsat=Sp a O 2 −Sp v O 2 and perfusion, which, as noted above, are parameters advantageously provided by the stereo pulse oximeter according to the present invention. Oxygen consumption at a peripheral site is obtained by multiplying the difference between peripheral arterial and venous oxygen content by perfusion at the site. VpO 2 =[O 2 content (arterial)−O 2 content (venous)]Φ  12) where oxygen content is measured in milliliters (ml) of O 2 per deciliters (dl) of blood and Φ denotes perfusion in deciliters per minute. Oxygen content, however, can be expressed in terms of the amount of oxygen bound to the hemoglobin plus the amount of oxygen dissolved in the plasma. The amount of bound oxygen is equal to the hemoglobin concentration, C hb , in grams per deciliter of blood, times the hemoglobin carrying capacity, which is 1.34 milliliters of O 2 per gram of hemoglobin times the hemoglobin oxygen saturation, SO 2 . The amount of dissolved oxygen is simply the partial pressure of oxygen, PO 2 , times the O 2 solubility coefficient in blood, which is 0.003 milliliters of O 2 per deciliter. The sum of these two terms yields: O 2 content=1.34C Hb SO 2 +0.003PO 2   (13) Substituting equation (13) into equation (12) yields the following equation for tissue oxygen consumption: VpO 2 =[1.34C Hb (Sp a O 2 −Sp v O 2 )+0.003(P a O 2 -P v O 2 )]φ (14) Except when the fractional inspired oxygen, FiO 2 , is high, blood plasma plays a minimal role in oxygen delivery. Thus, peripheral oxygen consumption is approximately: VpO 2 =[1.34C Hb Δsat]Φ  (15) [0094] In order to illustrate a schema of oxygen titration, it is convenient to characterize the relationship between oxygen supplied at the airway to oxygen consumed at a peripheral tissue site. Specifically, characterization of the relationship between Δsat, Φ and FiO 2 is useful. Assuming constant oxygen consumption at the tissue site, equation (15) is: Δsat Φ=constant  (16) Equation (16) has a simple analog in electronic circuits, i.e. a variable resistor across a current or voltage source adjusted to maintain constant power. In this analog circuit, the current through the resistor, I, is equivalent to perfusion, the voltage across the resistor, V, is equivalent to Δsat and the constant of equation (16) is equivalent to the constant power, P, consumed by the resistor. The equation representing this electrical analog is: V×I=P   (17) [0095] FIG. 17A shows a graph 1701 that depicts a family of curves each corresponding to different values of P in equation (17). The graph 1701 has an x-axis 1710 indicating current, I, and a y-axis 1720 indicating voltage, V. A first curve 1730 shows V versus I for a constant power, P, of 0.5 watts; a second curve 1740 shows V versus I for a constant P of 1 watt; and a third curve 1750 shows V versus I for a constant P of 2 watts. Using the analogy between equations (16) and equation (17), whenever Φ (current) is small, the Δsat (voltage) is large and vice-a-versa. Also, a change in consumption (power) causes a shift in the curve along with a change in its curvature. That is, if the body suddenly changes its metabolic rate at the peripheral tissue site, the curve will accordingly shift up or shift down and will change its shape. Equation (16) and the analogous constant consumption curves of FIG. 17A assume a supply independent condition, i.e. that peripheral oxygen consumption is satisfied by peripheral oxygen delivery. If the peripheral tissue site is starved for oxygen, then the locus of points for Δsat versus Φ is quite different from a hyperbola The amount of tissue oxygen extraction is at a maximum and is independent of Φ. Accordingly Δsat is at a maximum and independent of Φ. The above analysis provides insight into the relationship between Δsat and Φ. The relationship between Δsat and FiO 2 can also be characterized. [0096] FIG. 17B shows a graph 1702 of saturation along a y-axis 1760 and fractional inspired oxygen along an x-axis 1770 . A curve of Sp a O 2 1780 and a curve of Sp a O 2 1790 are depicted versus FiO 2 . The difference between these curves 1780 , 1790 yields Δsat 1785 versus FiO 2 . When FiO 2 is zero 1772 , oxygen saturation and, hence, both Sp a O 2 1780 and Sp v O 2 1790 are zero. As FiO 2 is increased, Sp a O 2 1780 also increases until virtually reaching 100 percent saturation 1762 . As FiO 2 increases further, Sp a O 2 1780 stays at virtually 100 percent saturation 1762 . As FiO 2 is increased from zero 1772 , Sp v O 2 1790 also increases. In this low FiO 2 region 1774 , the peripheral tissue site is supply dependent and Δsat 1785 also increases. At a certain point, the tissue site oxygen demand is met by supply. In this supply independent region 1776 , oxygen consumption is constant and equation (16) is valid. Also, Δsat 1785 is at a constant maximum, which is a function of the metabolism at the tissue site. As FiO 2 increases further, eventually the partial pressure of oxygen becomes significant and the second term of equation (14) must be considered. In this high FiO 2 region 1778 , Δsat 1785 decreases because some of the tissue oxygen consumption is supplied by oxygen dissolved in the plasma. [0097] FIG. 17C shows a graph 1704 of saturation difference along a y-axis 1764 and fractional inspired oxygen along an x-axis 1770 . A curve of Δsat 1786 is depicted versus FiO 2 , corresponding to the region Δsat 1785 depicted in FIG. 17B . The curve 1786 has a first deflection point 1766 occurring at the transition between the low FiO 2 region 1774 ( FIG. 17B ) and the supply independent region 1776 ( FIG. 17B ). The curve 1786 also has a second deflection point 1768 occurring at the transition between the supply independent region 1776 ( FIG. 17B ) and the high FiO 2 region 1778 ( FIG. 17B ). The curve 1786 illustrates how the trend for Δsat, as measured by the stereo pulse oximeter, can be used to accurately titrate oxygen. The goal of oxygen titration is to supply sufficient oxygen to supply tissue demand and avoid unnecessarily high amounts of FiO 2 . Thus, the Δsat parameter should be monitored so that FiO 2 is adjusted between the two deflection points 1766 , 1768 . For neonates, FiO 2 should be adjusted just beyond the first deflection point 1766 . For adults, FiO 2 should be adjusted just before the second deflection point 1768 . [0098] FIG. 18 illustrates a graph having a three-dimensional surface 1800 generally depicting the relationship between Δsat, Φ and FiO 2 from the combined graphs of FIGS. 17A and 17C . The graph has an x-axis 1810 showing FiO 2 , a y-axis 1820 showing Φ and a z-axis 1830 showing Δsat. The surface 1800 has a supply dependent region 1840 , a perfusion-limited region 1850 , a constant consumption region 1860 and a plasma dependent region 1870 . The surface describes the oxygen status of a peripheral tissue site. The supply dependent region 1840 corresponds to the low FiO 2 region 1774 ( FIG. 17B ) described above. That is, inspired oxygen into the lungs is so low that, at the tissue site, oxygen extraction by the tissues is limited by oxygen delivery, and Δsat falls rapidly as FiO 2 is reduced. The perfusion-limited region 1850 along the x-axis 1810 represents a low perfusion state where equation (16) is not valid. That is, perfusion at the tissue site is so low that oxygen extraction by the tissues is at a maximum, and, hence, Δsat is at a maximum and is independent of FiO 2 . A cross-section of the surface taken parallel to the y-axis 1820 yields a hyperbole-shaped constant consumption region 1860 , consistent with the constant metabolic rate curves illustrated above with respect to FIG. 17A . The plasma dependent region 1870 corresponds to the high FiO 2 region 1778 ( FIG. 17B ) described above. That is, inspired oxygen into the lungs is so high that the tissue site is partially dependent on oxygen dissolved in the plasma The surface 1800 illustrates that perfusion should be monitored simultaneously with Δsat to avoid the perfusion-limited region 1850 , where Δsat is an unresponsive indicator of FiO 2 , and to avoid misinterpreting hyperbolic changes in Δsat that result from changes in perfusion. [0099] Persistent Pulmonary Hypertension in Neonates [0100] FIG. 19 illustrates the heart/lung circulation of a hypertensive neonate. Persistent Pulmonary Hypertension in Neonates (PPHN) is a neonatal condition with persistent elevation of pulmonary vascular resistance and pulmonary artery pressure. Shown is a neonatal heart 1902 and a portion of a neonatal lung 1904 . The pulmonary artery 1910 that normally feeds oxygen depleted “blue” blood from the right ventricle 1920 to the lung 1904 is constricted. The back pressure from the constricted artery 1910 results in a right-to-left shunting of this oxygen depleted blood through the ductus arteriosus 1930 , causing it to mix with oxygen rich “red” blood flowing through the descending aorta 1940 . PPHN treatment options include vasodilators, such as nitric oxide (NO). Inhaled exogenous NO causes a dose-dependent decrease in pulmonary artery pressure and pulmonary vascular resistance, as well as a parallel increase in pulmonary blood flow, without affecting systemic arterial pressure. However, the response to NO therapy is a function of the cause of the PPHN as well as the time elapsed before initiation of therapy. Potential toxic effects of NO dictate the proper titration of NO gas. Too little NO may not effectively relieve pulmonary hypertension, and too much NO may cause cellular injury or toxicity. NO therapy is currently monitored using intermittent ultrasound imaging and/or in vitro blood gas measurements. The drawbacks to these techniques are noncontinuous monitoring and disturbances to the neonate that can exacerbate or not reflect the hypertension in the non-disturbed state. [0101] The stereo pulse oximeter according to the present invention allows noninvasive, continuous monitoring of a neonate for detection and managed treatment of PPHN that does not disturb the patient. A right hand sensor 130 ( FIG. 1 ) provides arterial oxygen saturation and a plethysmograph for blood circulating from the left ventricle 1950 through the innominate artery 1960 , which supplies the right subclavian artery. Because the innominate artery 1960 is upstream from the shunt at the ductus arteriosus 1930 , the oxygen saturation value and plethysmograph waveform obtained from the right hand are relatively unaffected by the shunt and serve as a baseline or reference for comparison with readings from other tissue sites. Alternatively, a reference sensor can be placed on a facial site, such as an ear, the nose or the lips. These sites provide arterial oxygen saturation and a plethysmograph for blood circulating from the left ventricle 1950 to the innominate artery 1960 , which supplies the right common carotid artery (not shown), or to the left common carotid artery 1965 . [0102] A foot sensor 120 ( FIG. 1 ) provides oxygen status for blood supplied from the descending aorta 1940 . The shunt 1930 affects both the oxygen saturation and the blood flow in the descending aorta 1940 . As stated above, the shunt 1930 causes oxygen-depleted blood to be mixed with oxygen-rich blood in the descending aorta 1940 . Because the descending aorta 1940 supplies blood to the legs, the oxygen saturation readings at the foot will be lowered accordingly. The PPHN condition, therefore, is manifested as a higher arterial oxygen saturation at the right hand reference site and a lower saturation at the foot site. [0103] The shunt also allows a transitory left to right flow during systole, which distends the main pulmonary artery 1980 as the result of the blood flow pressure at one end from the right ventricle and at the other end from the aortic arch 1990 . A left-to-right flow through the shunt 1930 into the distended artery 1980 alters the flow in the descending aorta 1940 and, as a result, the plethysmograph features measured at the foot. The PPHN condition, therefore, also is manifested as a plethysmograph with a narrow peak and possibly a well-defined dicrotic notch at the left hand baseline site and a broadened peak and possibly no notch at the foot site. [0104] An optional left hand sensor 110 ( FIG. 1 ) provides oxygen status for blood circulating from the left ventricle through the left subclavian artery 1970 that supplies the left arm. Because the left subclavian artery 1970 is nearer the shunt 1930 than the further upstream innominate artery 1960 , it may experience some mixing of deoxygenated blood and an alteration in flow due to the shunt 1930 . The PPHN condition, therefore, may also be manifested as a reduced saturation and an altered plethysmograph waveform at the left hand site as compared with the right hand baseline site, although to a lesser degree than with a foot site. Thus, the PPHN condition can be detected and its treatment monitored from Δsat and plethysmograph morphology comparisons between a right hand baseline sensor site and one or more other sites, such as the left hand or foot. [0105] Patent Ductus Arteriosus [0106] FIG. 20 illustrates the fetal heart/lung circulation. Shown is a fetal heart 2002 and a portion of a fetal lung 2004 . The lung 2004 is non-functional and fluid-filled. Instead, oxygenated blood is supplied to the fetus from gas-exchange in the placenta with the mother's blood supply. Specifically, oxygenated blood flows from the placenta, through the umbilical vein 2006 and into the right atrium 2022 . There, it flows via the foramen 2024 into the left atrium 2052 , where it is pumped into the left ventricle 2050 and then into the aortic trunk 2092 . Also, oxygenated blood is pumped from the right atrium 2022 into the right ventricle 2020 and directly into the descending aorta 2040 via the main pulmonary artery 2080 and the ductus arteriosus 2030 . Normally, the ductus arteriosus 2030 is only open (patent) during fetal life and the first 12 to 24 hours of life in term infants. The purpose of the ductus arteriosus 2030 is to shunt blood pumped by the right ventricle 2020 past the constricted pulmonary circulation 2010 and into the aorta 2040 . [0107] FIG. 21 illustrates a neonatal heart 2002 with a patent ductus arteriosus 2030 . The ductus arteriosus frequently fails to close in premature infants, allowing left-to-right shunting, i.e. oxygenated “red” blood flows from the aorta 2040 to the now unconstricted pulmonary artery 2010 and recirculates through the lungs 2004 . A persistent patent ductus arteriosus (PDA) results in pulmonary hyperperfusion and an enlarged right ventricle 2020 , which leads to a variety of abnormal respiratory, cardiac and genitourinary symptoms. Current PDA diagnosis involves physical examination, chest x-ray, blood gas analysis, echocardiogram, or a combination of the above. For example, large PDAs may be associated with a soft, long, low-frequency murmur detectable with a stethoscope. As another example, two-dimensional, color Doppler echocardiography may show a retrograde flow from the ductus arteriosus 2030 into the main pulmonary artery 2080 . Once a problematic PDA is detected, closure can be effected medically with indomethacin or ibuprofen or surgically by ligation. Multiple doses of indomethacin are commonplace but can still result in patency, demanding ligation. A drawback to current diagnostic techniques is that clinical symptoms of a PDA can vary on an hourly basis, requiring extended and inherently intermittent testing. [0108] The stereo pulse oximeter according to the present invention allows for continuous evaluation of PDA symptoms using non-invasive techniques. A right hand sensor 130 ( FIG. 1 ) provides arterial oxygen saturation and a plethysmograph for blood circulating from the left ventricle 2050 through the innominate artery 2160 , which supplies the right subclavian artery leading to the right arm. Because the innominate artery 2160 is upstream from the shunt at the ductus arteriosus 2030 , the oxygen saturation value and plethysmograph waveform obtained from the right hand are relatively unaffected by the shunt and serve as a baseline for comparison with readings from other tissue sites. [0109] A foot sensor 120 ( FIG. 1 ) provides oxygen status for blood supplied from the descending aorta 2040 . Unlike a PPHN condition, the shunt 2030 does not affect oxygen saturation in the descending aorta 2040 , because the relatively low pressure in the pulmonary artery 2010 does not allow a mixing of deoxygenated blood into the relatively high pressure flow of oxygenated blood in the aorta 2040 . However, like a PPHN condition, the shunt 2030 does affect the aortic flow. In particular, the shunt allows a transitory left-to-right flow during systole from the high pressure aorta 2040 to the low pressure pulmonary circulation 2010 . This left-to-right flow through the shunt 1930 alters the flow in the descending aorta 1940 and, as a result, the plethysmograph features measured at the foot. The PDA condition, therefore, is manifested as a normal plethysmograph with a characteristically narrow peak and well-defined dicrotic notch at the right-hand baseline site compared with a damped plethysmograph with a broadened peak and reduced or missing notch at the foot site. Further, the foot site waveform is phase shifted from the baseline waveform. These plethysmograph differences are accompanied by comparable arterial oxygen saturation values between the right-hand site and the foot site. [0110] An optional left hand sensor 110 ( FIG. 1 ) provides oxygen status for blood circulating from the left ventricle through the left subclavian artery 2170 that supplies the left arm. Because the left subclavian artery 2170 is nearer the shunt 2030 than the further upstream innominate artery 2160 , it may experience some alteration in flow due to the shunt 2030 . The PDA condition, therefore, may also be manifested as an altered plethysmograph waveform at a left hand site as compared with the right hand baseline site, although to a lesser degree than with a foot site. Thus, the PDA condition can be detected and its treatment monitored from Δsat xy ≈0 and plethysmograph morphology and phase comparisons between a right hand baseline sensor site and one or more other sites, such as the left hand or foot. One of ordinary skill will recognize that multiple site comparisons using the stereo pulse oximeter of the current invention may also be used to detect other cardiac abnormalities that cause mixing of oxygenated and deoxygenated blood, such as a ventricular hole or a patent foramen. Further, abnormal mixing of oxygenated and deoxygenated blood may also be manifested in measurements provided by the stereo oximeters other than Δsat xy and .Δpleth xy as described above. For example, an inversion in Δsat at a particular tissue site, i.e., Sp v O 2 being larger than Sp a O 2 at that site, would indicate such an abnormal condition. [0111] Aortic Coarctation [0112] Coarctation of the aorta is a congenital cardiac anomaly in which obstruction or narrowing occurs in the distal aortic arch or proximal descending aorta. It occurs as either an isolated lesion or coexisting with a variety of other congenital cardiac anomalies, such as a PDA. If the constriction is preductal, lower-trunk blood flow is supplied predominantly by the right ventricle via the ductus arteriosus, and cyanosis, i.e. poorly oxygenated blood, is present distal to the coarctation. This can be detected by the stereo pulse oximeter from a comparison of Sp a O 2 between an upper body and a lower body site. If the constriction is postductal, blood supply to the lower trunk is supplied via the ascending aorta Differential plethysmographs between the upper and lower extremities may not exist if the ductus is widely patent. If the ductus closes, however, this condition can be detected by the stereo pulse oximeter as a reduced amplitude and phase delay between the plethysmographs measured at a lower body site with respect to an upper body site. [0113] The stereo pulse oximeter has been disclosed in detail in connection with various embodiments of the present invention. These embodiments are disclosed by way of examples only and are not to limit the scope of the present invention, which is defined by the claims that follow. One of ordinary skill in the art will appreciate many variations and modifications within the scope of this invention.

1a

[0001] This is a continuation of International Application PCT/JP2005/008297 (published as WO 2005/107480) having an international filing date of 2 May 2005, which claims priority to JP 2004-139128 filed on 7 May 2004. The disclosure of the priority application, in its entirety, including the drawings, claims, and the specification thereof, is incorporated herein by reference. BACKGROUND [0002] To reduce the cost of making and distributing bread, distributors and bakeries recently adopted a method of freeze-storing baked bread at low temperature by introducing cooling air and then cooking the frozen bread to thaw and sell the bread restored to near fresh baked state. Referring to FIG. 11 , conventionally, baked bread is stored frozen after the bread is baked in a baking process 11 , and the baked bread whose surface temperature is 85° C. and above is cooled in a cooling process 21 for preliminarily cooling baked bread at high temperature in a cooling chamber at approximately −5° C. and below to make the surface temperature approximately 1 to 3° C. In a freeze-storing process 22 , the cooled bread is frozen to about −20° C. and at 50 to 70% RH to prepare for storing. [0003] Another related art discloses a method of freeze-storing bread while the bread is carried on a conveyor through a cooling chamber from an entrance to an exit and through a freezing chamber from an entrance to an exit. The conveyor carries bread thereon at a constant speed through the cooling chamber and the freezing chamber in which bread is cooled and frozen. According to this method, the bread is cooled in the cooling chamber while humidified air (pre-mixed with spray water) is supplied to the exit side and freeze-stored in the freezing chamber in which temperature is maintained at approximately −20° C. to be ready for the shipment. [0004] Japanese patent publication JP 11-346644A proposes another method of freeze-storing baked bread and confectionery. Here, fresh cakes are quickly frozen to bring its core temperature to 0° C. and below, stored at −18° C. and below and at high humidity, and thawed in a cool room of 0° C.±2° C. and at 50 to 70% RH. Cakes include sponge cakes and bread made from dough containing more than 40% soluble sugar in weight ratio of solid ingredients. This publication, however, does not disclose a method of freeze-storing baked bread for a long period, retaining excellent quality of the crust (surface layer of bread), good sensory condition, and preventing crust flaking. [0005] According to the inventors' tests, if the freezing process is performed for longer than a predetermined period, the baked bread processed by a conventional freeze-storing method shows crust staling and flaking, resulting in a weight decrease, thereby losing good texture and its commercial value. Moreover, In the conventional method, the exit side of the cooling chamber supplies humidified air, which is humidified by spraying cold water to air at room temperature. When water contained in the humidified air evaporates, taking evaporative latent heat from the surrounding, the ambient temperature decreases at the exit side of the cooling chamber, causing a temperature difference between the entrance side and exit side of the cooling chamber, which causes a drop in relative humidity inside the cooling chamber. This can deteriorate the quality of the baked bread. [0006] There still remains a need for improving the quality of freeze-stored baked goods so that they can be restored more closely to their original baked condition, namely to retain excellent crust quality of baked food and also to prevent crust flaking while maintaining the quality and sensory condition of fresh baked food even after a long period of freeze-storing. The present invention addresses this need. SUMMARY OF THE INVENTION [0007] The present invention relates to an apparatus and a method for freeze-storing baked goods, such as baked bread and confectionary in a humidified atmosphere. [0008] One aspect of the present invention is an apparatus for freeze-storing baked food in an atmosphere of high or medium humidity. The apparatus comprises a cooling chamber, a pre-mixing device, a freezing chamber, and at least one conveyor. The cooling chamber is maintainable at room temperature and high or medium humidity. The pre-mixing device pre-mixes air at room temperature with warm water spray and introduces the pre-mixed air into the cooling chamber. The freezing chamber is maintainable below the freezing point of the baked food and below. The conveyor conveys the baked food in and out of the cooling chamber and the freezing chamber. The cooling chamber and freezing chamber are provided separately. The period of freezing the baked good in the freezing chamber is longer than the period of cooling the baked good in the cooling chamber. [0009] The pre-mixed air from the pre-mixing device is introduced to an exit side of the cooling chamber, and ambient temperature on the exit side of the cooling chamber is controlled to be near the room temperature, which is about the same as the ambient temperature on an entrance side of the cooling chamber. The freezing chamber is at the freezing point and below and at lower humidity than the cooling chamber. [0010] When the cooling chamber is maintained medium humidity of 45-60% RH, water is sprayed on the surface of the baked food before introducing the baked food into the cooling chamber. [0011] Another aspect of the present invention is a method of freeze-storing baked food. The method includes a cooling step of cooling the baked food in a cooling chamber having an atmosphere of high or medium humidity, a first freezing step of freeze-storing the baked food in an atmosphere of the freezing point and below and high humidity after the cooling step, and a second freezing step of freeze-storing the baked food in an atmosphere of the freezing point and below and humidity lower than the first freezing step after the first freezing step. The second freezing step is performed for a longer period than the first freezing step, and when the cooling chamber has the atmosphere of medium humidity, the surface of the bake food can be sprayed with water before the cooling step. [0012] The cooling step includes pre-mixing air at room temperature with warm water spray, and introducing the pre-mixed air into the cooling chamber. The temperature of the water spray is higher than that of the pre-mixed air. The pre-mixed air can be introduced into an exit side of the cooling chamber having the atmosphere of high humidity. The temperature of the atmosphere of the exit side of the cooling chamber is thus controlled to be at room temperature, which is approximately the same as that of an entrance side of the cooling chamber. [0013] The cooling step is performed to cool the baked food so that the core (crumb) of the baked food is at the temperature of 30 to 35° C., and the atmosphere of the cooling chamber is maintained highly humid at 20 to 28° C. and 65% RH and above, even when the pre-mixed air is introduced therein. When the relative humidity of the cooling chamber during the cooling step is between 45% RH and 60% RH, water is sprayed on the surface of the baked food before the cooling step. [0014] The baked food can include half-baked bread and fully baked bread. The cooling step includes pre-mixing air at room temperature with warm water spray and introducing the pre-mixed air into the cooling chamber at high humidity. The temperature of the water spray is higher than that of the pre-mixed air. When the relative humidity during the cooling step is between 45% RH and 60% RH, water can be sprayed on the surface of the baked food before the cooling step. [0015] The baked food is cooled in the cooling chamber at high humidity in the cooling step, and then plainly wrapped and freeze-stored in a freezing box at below the freezing point and high humidity in the first freezing step. The cooling step can include cooling the fresh baked food in the atmosphere of high humidity in which the temperature difference from an entrance to an exit of the cooling chamber is within ±5° C. to bring the crust temperature to room temperature, and subsequently freezing the same rapidly in the first freezing step. The first cooling step can include cooling the baked food for less than 60 minutes in the cooling chamber while the humidity in the cooling chamber is kept above 90% RH to bring the surface temperature of the baked food to near 30° C. [0016] The baked food can be freeze-stored in the atmosphere of −30 to −40° C. to make the core temperature −10° C. and below. BRIEF DESCRIPTION OF THE DRAWINGS [0017] FIG. 1 schematically illustrates an apparatus for freeze-storing baking food according to the present invention. [0018] FIG. 2 is a table showing the test conditions. [0019] FIG. 3 is a table showing the cooling/freezing temperature. [0020] FIG. 4 is a graph showing the transition of cooling/freezing temperature in test Nos. 1 and 4. [0021] FIG. 5 is a graph showing the transition of cooling/freezing temperature in test No. 5. [0022] FIG. 6 is a graph showing the transition of cooling/freezing temperature in test No. 6. [0023] FIG. 7 is a table showing the test results. [0024] FIG. 8 schematically illustrates a freeze-storing system for baked food according to the present invention. [0025] FIG. 9 is a table showing a comparison of evaluation test results of freeze-stored baked bread. [0026] FIGS. 10A and 10B are graphs illustrating test results regarding crust flaking of freeze-stored baked bread. [0027] FIG. 11 schematically illustrates a conventional freeze-storing system. DETAILED DESCRIPTION [0028] Preferred embodiments according to the present invention will now be detailed with reference to the accompanying drawings. It is intended, however, that unless particularly specified, dimensions, materials, relative positions and so forth of the constituent parts in the embodiments shall be interpreted as illustrative only and not as limitative of the scope of the present invention. [0029] Referring to FIG. 1 , a freeze-storing apparatus for cooling and freezing baked food includes a cooling chamber 1 for cooling baked food in high or medium humidity, a freezing chamber 2 for freezing baked food, and a conveyor 3 for conveying baked food. The cooling chamber 1 is configured to be sealed hermetically so that desired temperature and humidity can be maintained inside. The freezing chamber 2 also is sealed hermetically so that temperature inside can be maintained at freezing temperature and below, and desired humidity. The conveyor 3 transfers baked food through the cooling chamber 1 and the freezing chamber 2 . [0030] Here, baked food or goods refer to fully baked or half baked bread and confectionary. In both instances, the crust part is fully baked to prevent water from being absorbed inside when spraying water on the crust. Moreover, humidity means relative humidity (RH) and high humidity means that the relative humidity (RH) is 65% and above, and medium or mid-humidity means that the relative humidity is 45-60% RH. [0031] In freeze-storing baked goods, the most important thing is to keep the constant humidity of the core of baked food. Therefore, it is necessary to cool the baked food to bring the core temperature 30 to 35° C. by maintaining the temperature and high humidity in the cooling atmosphere. The freshly baked food can be cooled in the cooling chamber at 90% RH and above thus to bring the surface temperature of the baked food to near 30° C. Freshly-baked bread is laid in the cooling chamber or traveled in the cooling chamber of high humidity, thereby lowering its temperature near room temperature with enough moisture maintained in the crust. Thus, baked food can be processed, maintaining excellent crust condition and preventing crust flaking. When the humidity is between 45% RH and 60% RH, water can be sprayed on the surface of the baked bread before the cooling process. By spraying water, only the water from the surface of baked food evaporates, preventing the water evaporation from the inside of baked food, and keeping the appropriate moisture inside even when the surrounding is at mid-humidity, i.e., 45 to 60% RH. [0032] The conveyor 3 is formed of vertical conveyors 4 , 5 and horizontal conveyor 7 . The conveyor 3 is in the form of a vertical conveyor 4 , 5 inside the cooling and freezing chambers 1 , 2 and is configured to move in the vertical direction. Its speed can be adjusted so that the baked food can travel on the conveyor in the chambers 1 , 2 for a desired period of time. [0033] A pre-mixed air chamber 6 can be located at the exit side of the cooling chamber 1 . The chamber 6 takes in air a and produce pre-mixed air m by spraying warm water h to the air a. The pre-mixed air m is sprayed in the atmosphere on the exit side of the cooling chamber 1 . In this case, the temperature of the sprayed water h is preferably higher than that of the pre-mixed air. Introducing the pre-mixed air in the exit side of the cooling chamber 1 prevents temperature drop as the water contained in the pre-mixed air evaporates taking evaporative latent heat from the surrounding. In the cooling chamber 1 , temperature of the atmosphere on the exit side is maintained by introducing the pre-mixed air m of high humidity and high temperature from the pre-mixed air chamber 6 . When water contained in the pre-mixed air m evaporates taking evaporative latent heat from the surrounding, the pre-mixed air of high humidity and high temperature provides heat to maintain the atmospheric temperature on the exit side of the cooling chamber 1 . Therefore, the cooling chamber 1 can be maintained approximately at room temperature and high humidity on both the entrance and exit sides. [0034] With this structure, baked food is placed on the conveyor 3 and enters the cooling chamber 1 from the entrance 1 a . The baked food is conveyed through the cooling chamber 1 on the vertical conveyor 4 at prescribed speed for a desired period and is cooled in the cooing chamber 1 . The baked food comes out from the exit 1 b of the cooling chamber 1 and enters the freezing chamber 2 from the entrance 2 a on the horizontal conveyor 7 . The baked bread is carried through the freezing chamber 2 on the vertical conveyor 5 to move in the vertical direction inside the freezing chamber 2 , thereby freeze-storing the baked bread to the temperature below the freezing point, i.e., −30 to −40° C. The baked food is freeze-stored in the atmosphere of −30 to −40° C. to make the core temperature −10° C. and below. The baked bread coming out from the exit 2 b of the freezing chamber 2 is retrieved at station 8 packed and shipped at station 9 to stores such as convenient stores. [0035] The constant temperature and high humidity inside the cooling chamber 1 is maintained by introducing the pre-mixed air m of high humidity and high temperature. The pre-mixed air provides heat and humidity to maintain the constant temperature and high humidity inside the chamber 1 as the water contained in the pre-mixed air m evaporates taking evaporative latent heat from the surrounding. Therefore, the cooling chamber 1 is maintained approximately at room temperature and high humidity on both the entrance and exit sides, and the baked food can be cooled, lowering the core temperature to 30 to 50° C. and maintaining high humidity. The temperature of the freezing chamber 2 is kept below the freezing point of baked food, e.g., −30 to −40° C. so that even large bread can be frozen to below the freezing point. [0036] The result of cooling and freezing tests is described below. Half-baked Zopf (braided bread) (500 g/unit), i.e., partially baked, was tested under various conditions. Zopf is rich bread made from flour 100, salt 2, yeast 0.8, water 62, fat 5, egg 5 and others in weight ratio. After mixing ingredients and fermenting the dough, bread was baked for the primary baking. The primary-baked bread was divided into one for spraying water and the other for no spraying on the crust, and cooled and frozen under the conditions shown in FIG. 2 . The bread was baked in an oven at a store for the final baking (175° C. for 11 min. →190° C. for 5 min) and evaluated. The result of the tests is shown in FIGS. 3-7 . [0037] In the sensory test, Test No. 1 showed the best result and Test No. 4 showed the second best result (showed water spots partially). The bread of test No. 5 came out too soft and loose and its color was bad. The bread of Test No. 6 had thick crust and the quality was poor. As this sensory test shows, good result was obtained from Test Nos. 1 and 4 in which during the cooling process the temperature and humidity was kept high at 26 to 27° C. and 49% RH plus water spray in Test No. 1 and 65% RH in Test No. 4 and cooling time was long, 62 minutes, and after the cooling process the core temperature was kept at 30 to 35° C. This test was carried out using half-baked bread. In the case of testing fully baked bread, the fully baked bread whose crust was sprayed with water did not show crust flaking maintaining good quality as the crust was hard and kept the water out, preventing deterioration. [0038] Referring to FIGS. 8-10B , bread baked in the baking process 11 having a crust temperature 88 to 96° C. is stored in the cooling chamber in which a humidifying process 12 is performed. In the humidifying process 12 , the baked bread at high temperature is highly humidified inside the cooling chamber approximately at 34° C. and above 95% RH, and in a cooling process 13 the baked bread is cooled inside the chamber of high temperature and high humidity for about 60 minutes to lower the crust temperature to about 30 to 33° C. In the humidifying process 12 and the cooling process 13 , freshly-baked bread at high temperature is cooled in the cooling chamber, thereby lowering its temperature near room temperature while holding enough moisture in the crust of the baked bread. [0039] After the cooling process, the baked bread is plainly wrapped and conveyed into the freezing chamber. Here, “plainly wrapped” means wrapping baked food plainly enough to prevent water evaporation from the surface layer between the cooling chamber and freezing chamber. By plainly wrapping the baked bread coming out of the cooling chamber, the water evaporation from the crust is prevented while conveying the baked bread from the cooling chamber to the freezing chamber. [0040] The freezing chamber is controlled such that the temperature inside is −17 to −20° C. and the relative humidity is 50 to 70% RH. Inside the freezing chamber has a freeze box controlled to be at the temperature of −17 to −19° C. and high relative humidity, 80 to 85% RH. The baked bread is stored in the freezing box during a high-humidity freeze-storing process 15 . By performing the high-humidity freeze-storing process 15 , the baked bread is freeze-stored while holding enough moisture in the crust, thereby retaining good quality. It is also possible to cool freshly baked bread slowly in the high-humidity atmosphere to bring the crust temperature to room temperature and then to freeze the cooled bread rapidly. Here, cooling “slowly” means to cool the baked food at a slow speed so that the temperature difference from the entrance to the exit of the cooling chamber is small (within ±5° C.). The cooling period of the baked food traveling from the entrance to the exit of the cooling chamber can be 35 to 80 minutes. [0041] The humidifying process 12 and the cooling process 13 are performed on freshly baked bread so that its temperature is lowered near to the room temperature while maintaining enough moisture in the crust, and the plain wrapping process is performed for preventing water evaporation from the crust. Then the high-humidity freeze-storing process 15 is performed by storing the plainly wrapped bread in the freezing box in which the temperature is kept below the freezing point (−17 to −20° C.) and the humidity is kept high at 80 to 85% RH. Thus, the baked bread maintains enough moisture in the crust from baking to freeze-storing, thereby maintaining good crust quality and preventing crust flaking, and further freeze-storing for long period while maintaining good sensory condition. [0042] According to another process, the baked bread can be sent to the high-humidity freeze-storing process 15 and then to the lower-humidity freeze-storing process 16 . In the high-humidity freeze-storing process 15 , the baked bread is freeze-stored for a short period of time, e.g., two days in the freezing box of low temperature and high humidity inside the freezing chamber of low temperature and lower humidity. Next in the lower-humidity freeze-storing process 16 , the baked bread is further freeze-stored for longer period of time than the high-humidity freeze-storing process 15 , in which the temperature is kept below the freezing point of bread with the relative humidity of 50 to 70% RH. [0043] In many cases, baked bread is freeze-stored for a short period and shipped to stores. However, by performing the high-humidity freeze-storing 15 even for a short period, baked bread can be freeze-stored holding enough humidity in the crust and shipped to stores without quality deterioration. [0044] FIG. 9 shows a comparison of evaluation test results of freeze-stored baked bread and non freeze-stored baked bread. FIG. 9 also shows freezing conditions and the sensory evaluation. Half-baked Zopf (braided bread) (500 g/unit), which is partially baked bread, was tested under various conditions. The bread used for the test was baguette made from flour 100, salt 1.9, yeast 1.0, water 63.3 in weight ratio. After mixing ingredients well to make the dough, the dough is primary-fermented for 2 hours at 28° C., punched down for pushing the air out, final-fermented for 1 hour at 30-35° C., and baked in the oven for 20 to 25 minutes at 230° C. [0045] In FIG. 9 , Case Nos. 1-3 are freeze-stored according to the present invention. Case Nos. 4-6 are freeze-stored according to comparative examples. Case Nos. 1 and 2 were processed in the humidification process 12 , the cooling process 13 inside the cooling chamber, and the high-humidity freezing process 15 inside the freezing box. Case No. 3 was processed in the high-humidity freezing process 15 inside the freezing box followed by the lower-humidity freeze-storing process 16 . Bread in Case Nos. 1 and 2 showed no defect such as crust flaking and retained great shape and excellent taste. On the other hand, baked bread of case Nos. 4-6 showing the comparative examples, which was not processed in the humidifying process 12 or cooling process 13 showed defects in shape and taste after freeze-storing. [0046] FIG. 10A shows the relation between the storing period and the crust flaking percentage in weight and FIG. 10B shows the relation between the storing period and the crust flaking percentage in area. As apparent from FIGS. 10A and 10B , crust flaking in Case Nos. 1-3 is suppressed to ⅓ of the comparative examples of Case Nos. 4-5. [0047] An apparatus and a method for freeze-storing baked foods including baked bread allows the baked food to be freeze-stored for a long time, while maintaining its good crust condition without crust flaking, and good sensory condition. [0048] Fresh baked food is cooled in a humidified atmosphere, and freeze-stored at temperature lower than the freezing point, namely at the atmosphere of −30 to −40° C. to make the core temperature −10° C. and below. Baked food is cooled to make the core temperature 30 to 35° C. in the atmosphere in which the cooling space is maintained highly humid at 20 to 28° C. and 65% RH and above (45% RH and above in the case of water-spraying the crust) even when the pre-mixed air is introduced therein. As a result, baked food can be freeze-stored maintaining excellent texture, flavor, and softness without deterioration in quality. [0049] When the humidity is between 45% RH and 60% RH, water can be sprayed on the surface of the baked bread before the cooling step. By spraying water, only the water from the surface of baked food evaporates, preventing the water evaporation from the inside of baked food, and keeping the appropriate moisture inside even when the surrounding is at mid-humidity, i.e., 45 to 60% RH. [0050] Further, freshly-baked food at high temperature can be cooled unattended in the atmosphere of high humidity such as inside the cooling chamber of high humidity, thereby lowering its temperature near room temperature, holding enough moisture in the crust of the baked food. By plainly wrapping the baked food after the cooling step, water evaporation from the crust can be prevented. Further, by storing the baked food in the freezing chamber of the freezing point and below, the baked food can be cooled to the freezing point with enough moisture in the crust, thereby achieving a freeze-storing of baked food maintaining excellent quality. [0051] Accordingly, freshly-baked food can be freeze-stored keeping enough moisture in the crust from post-baking to the freeze-storing step. Thus, the baked food maintains enough moisture in the crust from baking to freeze-storing, thereby maintaining good crust quality and preventing crust flaking, and further freeze-storing for long period maintaining good sensory condition can be achieved. [0052] With the above configuration of the present invention, this problem of the prior art can be solved and freeze-storing of baked food becomes possible maintaining excellent texture, flavor, softness, and others. [0053] While the present invention has been particularly shown and described with reference to preferred embodiments thereof, it will be understood by those skilled in the art that the foregoing and other changes in form and details can be made therein without departing from the spirit and scope of the present invention. All modifications and equivalents attainable by one versed in the art from the present disclosure within the scope and spirit of the present invention are to be included as further embodiments of the present invention. The scope of the present invention accordingly is to be defined as set forth in the appended claims.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of Provisional Patent Application No. 61/359,061, filed Jun. 28, 2010. BACKGROUND OF THE INVENTION This invention relates generally to storage containers and more particularly to a storage container adapted to measure and dispense a flowable material. For various reasons there is a need to store and dispense flowable materials, such as granules, particulates, powders, or liquids. For example, nutritional supplements, infant formula, and beverage mixes are often supplied as powders that must be mixed with water in specified proportions before use. Frequently these products are used away from a kitchen or other location where measuring implements are available. It is thus helpful to store a pre-measured quantity of the particular product ready for mixing. It is also desirable in many circumstances to store several identical portions of the same product for use throughout a day or week. Numerous types of containers are known which are capable of storing and/or dispensing flowable materials. However, known containers do not provide a convenient way of storing several identical portions, nor do they provide a convenient way of loading multiple portions without repeated measuring. BRIEF SUMMARY OF THE INVENTION These and other shortcomings of the prior art are addressed by the present invention, which provides a container useful for storing and dispensing measured amounts of flowable material. According to one aspect of the invention, a storage and dispensing container includes: a housing having a bottom plate with a feed opening defined therein, and a generally cylindrical outer wall extending around an outer periphery of the bottom plate; a funnel disposed at a lower end of the housing, in flow communication with the feed opening; a drum having an outer wall defining an interior that is partitioned into at least two chambers which are open at upper and lower ends thereof, the wall including a cylindrical portion which is coupled to the outer wall of the housing, such that the drum is rotatable relative to the housing; and a removable cap which closes off the upper end of the drum. BRIEF DESCRIPTION OF THE DRAWINGS The invention may be best understood by reference to the following description taken in conjunction with the accompanying drawing figures in which: FIG. 1 is a side view of a storage and dispensing container constructed in accordance with an aspect of the present invention; FIG. 2 is a front cross-sectional view of the container of FIG. 1 ; FIG. 3 is an exploded cross-sectional view of the container of FIG. 1 ; FIG. 4 is a bottom plan view of the container shown in FIG. 3 ; FIG. 5 is a view taken along lines 5 - 5 of FIG. 3 ; FIG. 6 is a cross-sectional view taken along lines 6 - 6 of FIG. 5 ; FIG. 7 is a top plan view of the container; FIG. 8 is a view taken along lines 8 - 8 of FIG. 3 ; FIG. 9 is a cross-sectional view of two containers in a stacked assembly; FIG. 10 is a cross-sectional view of an exemplary receptacle for use with the container; FIG. 11 is a cross-sectional view of an exemplary receptacle for use with the container; FIG. 12 is an exploded perspective view of an alternative storage and dispensing container constructed in accordance with an aspect of the present invention; FIG. 13 is a side view of the container of FIG. 12 ; FIG. 14 is a top plan view of a housing of the container of FIG. 12 ; FIG. 15 is a view taken along lines 15 - 15 of FIG. 14 ; FIG. 16 is a view taken along lines 16 - 16 of FIG. 14 ; and FIG. 17 is a cross-sectional view of a portion of the container shown in FIG. 12 . DETAILED DESCRIPTION OF THE INVENTION Referring to the drawings wherein identical reference numerals denote the same elements throughout the various views, FIGS. 1-3 depict an exemplary storage and dispensing container constructed according to an aspect of the present invention, referred to hereinafter simply as a “container” 10 . The container has a cap 12 placed over its upper end and is shown placed over a receptacle “R”, such as a mug or cup. The container 10 is suitable for storing and selectively dispensing any type of flowable material. As used herein the term “flowable material” refers to any substance which is capable of deforming under shear stress and flowing, such as granular materials, particulates, powders, and liquids. Referring to FIGS. 1-3 , the container 10 comprises a housing 14 with a rotating drum 16 disposed therein. A carrying handle 11 may be incorporated with the container 10 . The housing 14 has a generally cylindrical wall 18 with an upper rim 20 and a lower edge that is formed into a flared lip 22 . The lip 22 is capable of receiving the upper edge 24 of the receptacle R. An upright cylindrical tube 26 is disposed in the center of the housing 14 . The housing 14 and other constituent parts of the container 10 may be made from any material which is sufficiently rigid to maintain the required shapes. Nonlimiting examples include plastic, metal, fiberboard, and the like. The various components of the container 10 may be formed as an integral whole (for example by injection molding) or may be formed separately and then assembled, for example using adhesives, snap- or friction-fit joints, bonding processes (e.g. thermal or ultrasonic), or mechanical fasteners. As best seen in FIG. 3 , the tube 26 is held in place within the housing 14 by a bottom plate 28 which is generally circular. A wedge-shaped segment is removed from the bottom plate 28 to define a feed opening 30 (see FIG. 5 ). In the illustrated example the feed opening 30 spans an angle of about 90 degrees. A funnel 32 is disposed underneath the bottom plate 28 (see FIG. 4 ). In plan view the funnel 32 is generally wedge-shaped and is centered under the feed opening 30 . The funnel 32 is formed so as to transition smoothly into the lower end of the tube 26 . A valve 34 is provided to selectively open or close off the feed opening 30 as desired. In the illustrated example the valve 34 is a wedge-shaped plate with arcuate inboard and outboard edges 36 and 38 . The valve 34 spans an angle slightly larger than the angle of the feed opening 30 . The inboard edge 36 is supported by a retaining ring or ledge 40 , which may be part of the tube 26 , and the outboard edge 38 is supported by an outer edge of the funnel 32 . Arcuate rails 42 and 44 on the tube 26 and the wall 18 retain the inboard and outboard edges 36 and 38 , respectively. In this example the valve 34 is mounted at approximately the same plane as the remainder of the bottom plate 28 . Mounted in this fashion, the valve 34 is able to move along an arcing path. Means are provided for moving the valve 34 between positions. In the illustrated example, a tab 46 formed as part of the valve 34 extends through an arcuate slot in the wall 18 of the housing 14 to allow manual operation of the valve 34 . FIG. 3 shows the drum 16 in more detail. It is generally cylindrical with concentric generally cylindrical inner and outer walls 48 and 50 . The inside diameter of the inner wall 48 is sized to fit closely over the tube 26 , and the outside diameter of the outer wall 50 is sized to fit closely within the wall 18 of the housing 14 , so that the drum 16 can rotate freely within the housing 14 . Partitions 52 (see FIG. 7 ) extend between the inner and outer walls 48 and 50 so as to divide the annular space between the two walls into a plurality of chambers 54 which are open at both ends. The number and size of the chambers 54 may be chosen to suit a particular application. The overall volume of the chambers 54 may also be adjusted by scaling of the overall height “H” (see FIG. 3 ) of the drum 16 . As described in more detail below, it may be desirable to provide a particular total drum capacity either through a small number of large chambers 54 or a large number of small chambers 54 . The number of chambers 54 , and thus the angle spanned by each chamber 54 , matches the angle spanned by the feed opening 54 . In the illustrated example, the drum 16 is divided into four chambers 54 . It is also possible to divide the interior of the drum 16 into chambers 54 of unequal sizes. The cap 12 includes a generally circular outer shell 56 with a generally “U”-shaped cross section, and an inner liner 58 with a similar cross-sectional shape. A vent 60 is provided through the outer shell 56 and may be of a shielded type as shown. One or more vent holes 62 (only one is shown) pass through the inner liner 58 (see FIG. 8 ). When assembled to the container 10 , the cap 12 , specifically the inner liner 58 , seals against the upper edges of the drum 16 and the wall 18 of the housing 14 , to prevent spillage of any flowable material from the chambers 54 . The cap 12 may be provided with means to securely fasten it to the container 10 . In the illustrated example, the cap 12 includes several spaced-apart lugs 64 which extend inward from the lip 22 . The upper edge of the housing 14 includes corresponding lugs 66 (see FIG. 7 ). When the cap 12 is placed over the container 10 and rotated a fraction of a turn, the lugs 64 and 66 engage each other and hold the cap 12 and the container 10 together. The container 10 is provided with means for rotating the drum 16 . In the illustrated example, best seen in FIG. 7 , the upper portion of the outer wall 50 of the drum 16 has an array of detent slots 68 formed therein. A slider 70 is carried by the housing 14 near the upper rim 20 . As seen in FIGS. 2 and 7 , the wall 18 incorporates a lower slider track 72 around part of its periphery. The slider 70 is an arcuate band with an outwardly-protruding handle 74 and an inwardly-protruding, resilient finger 76 . The lower edge of the cap 12 defines an upper slider track 80 . Cooperatively, the upper and lower slider tracks 72 and 80 restrain the slider 70 in position and allow it to move in an arc between fixed stops 82 and 84 , with the finger 76 bearing against the outer wall 50 of the drum 16 . Moving the slider 70 in one direction allows the finger 76 to slip past the detent slots 68 , while moving it in the opposite direction causes the finger to engage one of the detent slots and thereby cause the drum 16 to rotate along with the slider 70 . Preferably, the fixed stops 82 and 84 and the size of the slider 70 are selected so that a full cycle of motion between the fixed stops 82 and 84 will result in the drum 16 being indexed by exactly one chamber 54 . In order to prevent backwards motion of the drum 16 during rotation, the housing 14 may be provided with a fixed resilient ratchet finger 86 that engages each detent slot 68 as it passes by during drum rotation. The container may be configured to be stackable. FIG. 9 shows an example of two identical containers labeled 10 A and 10 B, both identical in construction to the container 10 described above and having corresponding components. The upper container 10 A is placed over top of the lower container 10 B so that its lower flared lip 22 A engages the upper rim 20 B of the lower container 10 B. If desired, the containers 10 A and 10 B may be provided with a twist-lock arrangement of lugs as described above. The cap 12 is then secured to the upper container 10 A. The tubes 26 A and 26 B of the respective containers 10 A and 10 B form a continuous flowpath to the receptacle R. In the illustrated example, the tubes 26 A and 26 B are made slightly shorter than the height of the drums 16 A and 16 B so as to allow the tube 26 A of the upper container 10 A to nest into the lower container 10 B. Using this arrangement, any number of containers 10 A, 10 B, etc. may be stacked. Referring back to FIG. 2 , the container 10 is used by removing the cap 12 , making sure the valve 34 is in the closed position, and then filling the chambers 54 with the flowable material of choice. The individual chambers 54 are sized so as to provide multiple pre-measured portions without multiple measuring steps. For example, if a portion size of a particular nutritional supplement powder is about 89 ml (3 oz.), then each chamber 54 would be sized to contain exactly that volume. The entire container 10 can be dipped into a large package of the flowable material to overfill the chambers 54 and then scraped off level with a suitable implement. The cap 12 is then replaced and the container is ready for use. The container 10 keeps multiple individual portions of flowable material ready for dispensing. To dispense material, the user simply places the container 10 over a suitable surface or receptacle R and slides the valve 34 to the open position. This allows the flowable material in the chamber 54 which is aligned with the valve 34 to flow past the valve 34 and through the feed opening 30 into the funnel 32 , which guides the flowable material out through the tube 26 . A path is provided from the vent 60 and the vent hole 62 into the active chamber 54 to ensure that the flowable material can flow freely. The valve 34 is then closed and the slider 70 is actuated to bring a full chamber 54 over the feed opening 30 ready to be dispensed. The container 10 may be used for multiple measurements. For example, the individual chamber volume may be some integral fraction of a desired portion. In the example recited above where each chamber 54 holds about 89 ml (3 oz.), then dispensing the contents of two chambers 54 would produce a total of about 178 ml (6 oz.). When using the containers in a stacked arrangement, flowable material can be dispensed without disassembling the containers. For example, referring to the containers 10 A and 10 B shown in FIG. 9 , material may be dispensed from the upper container 10 A by simply opening its valve 34 A. The material will then flow through the tube 26 A of the upper container 10 A into the tube 26 B of the lower container 10 B and then into the receptacle R. In addition to simply providing additional storage capacity, this combination is also helpful if it is desired to dispense varying amounts of flowable material. For example, if each chamber 54 B of the lower container 10 B holds about 89 ml (3 oz.), and each chamber 54 A of the upper container 10 A holds about 59 ml (2 oz.), then discharging one chamber 54 B and one chamber 54 A will result in a total portion of about 148 ml (5 oz.). As noted above the container 10 may be used to store and dispense any type of flowable material. One example of a flowable material would be a powdered nutritional supplement, beverage mix, or baby formula. FIG. 10 illustrates a cup 88 which incorporates a cylindrical upper portion 90 and a flared, frusto-conical lower portion 92 . The shape of the cup 88 may be helpful in mixing such powdered materials with a liquid because of the mixing action imparted in the lower portion 92 when the cup 88 is swirled in a circular motion. The container 10 may also be used to store products such as spices, dry food mixes, or even chopped vegetables. In these situations it may be desirable to dispense the product onto a surface such as a countertop rather than directly into a receptacle. To accommodate this type of use the container 10 may be mounted on a stand 94 such as the one shown in FIG. 11 . This incorporates a simple ring 96 with a plurality of legs 98 extending downward. In use the stand would be placed on the surface and the lip 20 of the container 10 placed over the top edge of the ring 96 . The container 10 may be scaled as needed to suit a particular application. While the examples above have described material capacities of several ounces, the same principals may be used to make containers having capacities of many pounds or even hundreds or thousands of pounds, using the appropriate structural materials. FIGS. 12-17 illustrate an alternative container 110 constructed according to the principles of the present invention. Referring to FIGS. 12 and 13 in particular, the basic components of the container 110 are a housing 114 , a drum 116 , a funnel 132 , a cap 112 , and a bottom cap 134 . In the illustrated example, a flexible tether 113 extends between the cap 112 and the drum 116 . The housing 114 (seen in FIGS. 14-16 ) has a generally cylindrical outer wall 118 with an upper edge 120 and a lower edge 122 . The housing 114 and other constituent parts of the container 110 may be made from any material which is sufficiently rigid to maintain the required shapes. Nonlimiting examples include plastic, metal, fiberboard, and the like. The various components of the container 110 may be formed as an integral whole (for example by injection molding) or may be formed separately and then assembled, for example using adhesives, snap- or friction-fit joints, bonding processes (e.g. thermal or ultrasonic), or mechanical fasteners. A bottom plate 128 which is concave-curved and generally circular in plan view spans the interior of the outer wall 118 . A wedge-shaped segment is removed from the bottom plate 128 to define a feed opening 130 . In the illustrated example the feed opening 130 spans an angle of about 90 degrees. A handling flange 136 with a slight downward curvature extends radially outward from the exterior surface of the outer wall 118 . The handling flange 136 provides a secure grip for manipulating the housing 114 , and may have a generally polygonal or otherwise noncircular shape to prevent the container 110 from rolling if placed on its side. A groove 138 is formed in the interior surface of the outer wall 118 . Short vertical notches 140 are spaced around the periphery of the outer wall's interior surface, at its upper edge 120 . The number of notches 140 corresponds to the number of chambers 154 of the drum, as described below. An annular retention flange 142 with an L-shaped cross-section extends downward from the handling flange 136 . It is spaced a short distance outboard of the outer wall 118 so as to accommodate the funnel 132 . The funnel 132 is disposed underneath the bottom plate 128 (see FIG. 17 ). The funnel 132 has a generally frustoconical body 146 and a short generally cylindrical discharge tube 148 at its bottom end. A series of concentric annular rims 156 extend axially away from the body 146 , near the discharge tube 148 . The sizes of the rims 156 are selected so as to seat over the top edge of a receptacle such as a can, glass, or bottle (not shown). An annular, radially-outwardly-extending barb 158 is formed at the upper edge of the body 146 . The drum 116 is generally a body of revolution with an outer wall 150 . In this example the drum 116 is tapered in diameter from top to bottom. The outer wall 150 defines a short generally cylindrical coupling tube 160 at its bottom end. The outside diameter of the coupling tube 160 is sized to fit closely within the outer wall 118 of the housing 114 , so that the drum 116 can rotate freely within the housing 114 . Partitions 152 extend across the interior of drum 116 , so as to divide it into a plurality of chambers 154 . The number and size of the chambers 154 may be chosen to suit a particular application. The overall volume of the chambers 154 may also be adjusted by scaling of the overall height of the drum 116 . It may be desirable to provide a particular total drum capacity either through a small number of large chambers 154 or a large number of small chambers 154 . The number of chambers 154 , and thus the angle spanned by each chamber 154 , matches the angle spanned by the feed opening 130 . In the illustrated example, the drum 116 is divided into four chambers 154 . All but one of the chambers 154 are open at both their top and bottom ends. One of the chambers 154 ′ is closed off by an end wall 162 , which closely conforms to the bottom wall 128 of the housing 114 . A plug 164 (see FIG. 12 ) is installed in the top of this chamber 154 ′ to close it off completely. An annular flange 166 protrudes from the outer surface of the coupling tube 160 . When assembled, the flange 166 engages the groove 138 of the housing 114 so as to couple the drum 116 and the housing 114 together and permit them to rotate relative to each other. One or more vertically-oriented ribs 168 (seen in FIG. 12 ) protrude from the outer surface of the coupling tube 160 . When the drum 116 is rotated relative to the housing 114 , the ribs 168 gently force the upper edge 120 of the outer wall 118 of the housing 114 outboard. When they are aligned with one of the notches 140 , the ribs 168 and the notches 140 engage each other to hold the drum 116 in a desired position, acting as a detent mechanism. The notches 140 and ribs 168 are arranged so that one of the chambers 154 or 154 ′ is aligned with the feed opening 130 in each of the “stopped” positions. The bottom cap 134 is sized and shaped to close off the discharge tube 148 of the funnel 132 in a snap or press fit, and to be readily removable. In the illustrated example, a flexible tether 170 (seen in FIG. 12 ) extends between the bottom cap 134 and the housing 114 , and is coupled to the housing by pins 172 pivoted in grooves 174 of a lug 176 of the housing 114 . Referring back to FIG. 12 , the container 110 is used by removing the cap 112 , making sure the drum 116 is turned so that the closed chamber 154 ′ is over the feed opening 130 , and then filling the chambers 154 with the flowable material of choice. The individual chambers 154 are sized so as to provide multiple pre-measured portions without multiple measuring steps. For example, if a portion size of a particular nutritional supplement powder is about 89 ml (3 oz.), then each chamber 154 would be sized to contain exactly that volume. The entire container 110 can be dipped into a large package of the flowable material to overfill the chambers 154 and then scraped off level with a suitable implement. The cap 112 is then replaced and the container is ready for use. The container 110 keeps multiple individual portions of flowable material ready for dispensing. To dispense material, the user simply removes the bottom cap 134 , places the container 110 over a suitable surface or receptacle (not shown), and turns the drum 116 until one of the open chambers 154 is over the feed opening 130 . This allows the flowable material in the chamber 154 to flow through the feed opening 130 into the funnel 132 , which guides the flowable material out through the tube 126 . An air flow path can be provided into the active chamber 154 to ensure that the flowable material can flow freely. This may be done by providing a vent through the cap 112 (not shown) or by simply “cracking” or slightly opening the cap 112 while material is being dispensed. The bottom cap 134 is then replaced. Additional portions can be dispensed by again removing the bottom cap 134 and turning the drum 116 until another open chamber 154 is positioned over the feed opening 130 . The foregoing has described a storage and dispensing container. While specific embodiments of the present invention have been described, it will be apparent to those skilled in the art that various modifications thereto can be made without departing from the spirit and scope of the invention. Accordingly, the foregoing description of the preferred embodiment of the invention and the best mode for practicing the invention are provided for the purpose of illustration only.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] Not Applicable. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT [0002] Not Applicable. INCORPORATION BY REFERENCE OF MATERIAL SUBMITTED ON A COMPACT DISC [0003] Not Applicable. FIELD OF THE INVENTION [0004] The invention disclosed broadly relates to the field of jewelry and fashion accessories, and more particularly relates to the field of decorative accessories for the ears. BACKGROUND OF THE INVENTION [0005] An earring is a piece of jewelry attached to the ear via a piercing in the earlobe or another external part of the ear. Earrings are worn by both sexes, although more common among women, and have been used by different civilizations in different times. Common locations for piercings, other than the earlobe, include the rook, tragus, and across the helix of the ear. The simple term “ear piercing” usually refers to an earlobe piercing, whereas piercings in the upper part of the external ear are often referred to as “cartilage piercings.” Cartilage piercings are more complex to perform than earlobe piercings and take longer to heal. Ear piercing is one of the oldest known forms of body modification, with artistic and written references from cultures around the world dating back to early history. [0006] Earring components may be made of any number of materials, including metal, plastic, glass, precious stone, beads, wood, bone, and other materials. Designs range from small loops and studs to large plates and dangling items. The size is ultimately limited by the physical capacity of the earlobe to hold the earring without tearing. This leads to one of the drawbacks of conventional earrings—typically, earrings are sold in standard sizes that may fit a majority of wearers but do not fit a substantial minority of consumers. Further, earrings, earring components and other ear accessories have not developed or progressed in a substantial way in recent history. I.e., the earrings and ear accessories available today are almost identical to those available decades ago. [0007] Therefore, a need exists to overcome the problems with the prior art as discussed above, and particularly for a more efficient way of providing a variety of well-fitting ear accessories to consumers. SUMMARY OF THE INVENTION [0008] Briefly, according to one embodiment, an interchangeable door handle system is disclosed. This Summary is provided to introduce a selection of disclosed concepts in a simplified form that are further described below in the Detailed Description including the drawings provided. This Summary is not intended to identify key features or essential features of the claimed subject matter. Nor is this Summary intended to be used to limit the claimed subject matter's scope. [0009] The method for making a decorative ear cover includes generating a positive mold of a user's ear, placing the mold on a thermoforming machine, placing a thermoforming film in the thermoforming machine such that the thermoforming film is disposed over the positive mold, activating the thermoforming machine, so as to heat the thermoforming film, provide suction on a bottom side of the thermoforming film, and thermoforming the film to a shape of the positive mold, thereby generating a decorative ear cover, de-activating the thermoforming machine and removing the decorative ear cover from the thermoforming machine, and trimming sides of the decorative ear cover such that only portions of the thermoforming film that reflect the shape of the positive mold remain. [0010] The foregoing and other features and advantages of the present invention will be apparent from the following more particular description of the preferred embodiments of the invention, as illustrated in the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0011] The subject matter, which is regarded as the invention, is particularly pointed out and distinctly claimed in the claims at the conclusion of the specification. The foregoing and other features and also the advantages of the invention will be apparent from the following detailed description taken in conjunction with the accompanying drawings. Additionally, the left-most digit of a reference number identifies the drawing in which the reference number first appears. [0012] FIG. 1 is an illustration of a system for making a custom fit decorative ear cover, in accordance with one embodiment. [0013] FIG. 2 is an illustration of a vacuum molding system for making a custom fit decorative ear cover, in accordance with one embodiment. [0014] FIG. 3 is an illustration of the main components used during fabrication of the custom fit decorative ear cover, in accordance with one embodiment. [0015] FIG. 4 is an illustration of several views of several embodiment of a custom fit decorative ear cover, in accordance with one embodiment. [0016] FIG. 5 is an illustration of several views of several embodiments of a custom fit decorative ear cover, in accordance with one embodiment. [0017] FIG. 6 is an illustration of a custom fit decorative ear cover before placement on a consumer's ear, in accordance with one embodiment. [0018] FIG. 7 is an illustration of a custom fit decorative ear cover after placement on a consumer's ear, in accordance with one embodiment. DETAILED DESCRIPTION [0019] The following detailed description refers to the accompanying drawings. Wherever possible, the same reference numbers are used in the drawings and the following description to refer to the same or similar elements. While embodiments of the invention may be described, modifications, adaptations, and other implementations are possible. For example, substitutions, additions, or modifications may be made to the elements illustrated in the drawings, and the methods described herein may be modified by substituting, reordering, or adding stages to the disclosed methods. Accordingly, the following detailed description does not limit the invention. Instead, the proper scope of the invention is defined by the appended claims. [0020] In accordance with the embodiments described herein, a customized decorative ear cover is disclosed that overcomes the problems with the prior art as discussed above, by providing a decorative ear cover that is custom fit to a user's ear and provides the consumer with a variety of ear covers to choose from. Applicant's system provides a more efficient way of providing a variety of well-fitting decorative ear covers to consumers. The invention also provides an apparatus and method of making the custom fit decorative ear covers with a minimal number of component parts, thereby reducing the potential for failure or malfunction of the manufacturing process. Also, the minimal number of component parts of the custom fit decorative ear covers allows for quick and inexpensive fabrication of the device, thereby meeting the economic requirements for a decorative ear cover that allows for purchase of multiple ear covers. The ear covers can be constructed of various inexpensive materials, such as acrylic, plastic and rubber, as well as expensive materials such as precious stones and crystal. [0021] FIG. 1 is an illustration of a system 100 for making a custom fit decorative ear cover, in accordance with one embodiment. FIG. 1 shows the system 100 includes a thermoforming machine 102 (described more fully below) and various materials 120 , 122 for making negative mold impressions of a user's ear and positive molds 110 of a user's ear. System 100 also includes bowls 111 , 113 and spatula 117 for mixing the materials 120 , 122 . Lastly, the system 100 includes containers 115 for holding the materials 120 , 122 and thermoforming films 130 , 139 . [0022] In one embodiment, a user creates a viscous, thixotropic impression material by mixing materials 120 , 122 in a bowl or impression tray 111 using the spatula 117 . Alternatively, the impression material may be created by mixing materials 120 , 122 in an automated mixer. When complete, the impression tray 111 holding the impression material may then be placed on top of a vibrating machine 121 , which vibrated the impression tray so as to remove any air bubbles in the impression materia. Common materials 120 , 122 used to create the impression material are sodium alginate, polyether and silicones—both condensation-cured silicones and addition-cured silicones, such as polyvinyl siloxane. Alternatives include plaster of Paris, zinc oxide eugenol and agar. [0023] A negative mold impression of a user's ear can be made by placing the impression tray holding the impression material onto the user's ear such that the ear is enveloped in impression material. The impression material then sets to become an elastic solid, and, when removed from the ear, provides a detailed and stable negative mold impression of the ear. Subsequently, additional materials (such as materials 120 , 122 or the same impression material) are placed into the negative impression mold so as to create a positive mold 110 of the user's ear. The positive mold 110 is used to create a custom fit decorative ear cover using the thermoforming machine 102 . [0024] Thermoforming is a manufacturing process where a plastic sheet 130 or 139 is heated to a pliable forming temperature, formed to a specific shape in a positive mold 110 , and trimmed to create a usable product. The sheet or “film” 130 is heated (in a thermoforming machine 102 or in an oven) to a high-enough temperature that it can be stretched into or onto a positive mold 110 and cooled to a finished shape. In its simplest form, a small tabletop or lab size machine 102 can be used to heat small cut sections of a plastic sheet 130 and stretch it over a positive mold 110 using a vacuum created by a thermoforming machine 102 . This method is often used for sample and prototype parts. In complex and high-volume applications, very large production machines are utilized to heat and form the plastic sheet and trim the formed parts from the sheet in a continuous high-speed process. Thermoforming differs from injection molding, blow molding, rotational molding, and other forms of processing plastics. Thin-gauge thermoforming refers to the usage of thinner films 130 and thick-gauge thermoforming refers to the usage of thicker films 130 . [0025] In the most common method of high-volume, continuous thermoforming of thin-gauge products, a plastic sheet is fed from a roll or from an extruder into a set of indexing chains that incorporate pins, or spikes, that pierce the sheet and transport it through an oven for heating to forming temperature. The heated sheet then indexes into a form station where a mating positive mold and pressure-box close on the sheet, with vacuum or suction then applied to the underside of the sheet to remove trapped air and to pull the material into or onto the mold along with pressurized air to form the plastic to the detailed shape of the mold. After a short form cycle, a burst of reverse air pressure or reverse suction is actuated from the vacuum side of the mold as the form tooling opens, commonly referred to as air-eject, to break the vacuum and assist the formed parts off of, or out of, the mold. A stripper plate may also be utilized on the mold as it opens for ejection of more detailed parts or those with negative-draft, undercut areas. The sheet containing the formed parts then indexes into a trim station on the same machine, where a die cuts the parts from the remaining sheet web, or indexes into a separate trim press where the formed parts are trimmed. The sheet web remaining after the formed parts are trimmed is typically wound onto a take-up reel or fed into an inline granulator for recycling. [0026] Vacuum forming is a simplified version of thermoforming, whereby a sheet 130 of plastic is heated to a forming temperature, stretched onto or into a single-surface mold 110 , and held against the mold by applying a vacuum between the mold surface and the sheet 130 . Suitable materials for use in vacuum forming are conventionally thermoplastics. The most common and easiest to use thermoplastic is high impact polystyrene sheeting (HIPS), which can form to almost any shape. Vacuum forming is also appropriate for transparent materials such as acrylic. [0027] FIG. 2 is an illustration of a vacuum molding system for making a custom fit decorative ear cover, in accordance with one embodiment. FIG. 2 shows the films 130 , a positive mold 110 and a perforated flat element 202 . The positive mold 110 is placed on top of the flat element 202 , and the film 130 is placed inside of the clamp 210 of the vacuum forming machine 102 . (Whereas FIG. 1 shows the clamp 210 in a raised position, FIG. 1 shows the clamp 210 in a lowered position.) Once the positive mold 110 is placed on top of the flat element 202 , and the film 130 is placed inside of the clamp 210 , the heating lamp 215 is activated, which makes the film 130 more pliable and moldable. When the film 130 is adequately heated, the clamp 210 is lowered such that the film 130 is draped over the mold 110 and machine 102 is activated, wherein suction or a vacuum is placed on the underside of the sheet 130 (via the perforations in the flat element 202 ). The suction force draws the film 130 down over the mold 110 and thereby forms the decorative ear cover to reflect the contours and shape of the mold 110 . At this juncture, any of the interim steps described below, may be executed. [0028] Subsequently, the clamp 210 is raised and the decorative ear cover is removed from the mold 110 . Then, any pieces of the film 130 that do not reflect the contours and shape of the mold 110 are cut, clipped or removed from edges of the decorative ear cover. Lastly, one or more paints, fabrics, glitter, and/or decorative elements may be applied to the exterior of the decorative ear cover. Decorative elements include small rigid objects that maintain their shape during the thermoforming process, such as beads, crystals, stones, precious stones, buttons, cylindrical elements, toroidal elements, washers, bolts, nuts, etc. [0029] In one embodiment, decorative elements may be applied to the mold 110 before the step of forming the film 130 over the mold 110 . This would result in the decorative ear cover reflecting, or conforming to, the shape of the decorative element. This process is described in greater detail below. [0030] In another embodiment, an example interim step is executed as follows: one or more paints, fabrics, glitter, and/or decorative elements may be applied to the exterior of the decorative ear cover, and an additional or second film 139 may be applied over the same, using the steps described above. This results in a decorative ear cover that comprises a first or base film 130 , a layer of paints, fabrics, glitter, and/or decorative elements and a second or last film 139 disposed over the paints, fabrics, glitter, or decorative elements, such that the paints, fabrics, glitter, or decorative elements are protectively encased in the two layers of film. In this embodiment, the paints, fabrics, glitter, or decorative elements are sealed between the first film 130 and the second film 139 . This feature protects the paints, fabrics, glitter, or decorative elements from wear and tear and keeps them securely in place. [0031] FIG. 3 is an illustration of the main components used during fabrication of the custom fit decorative ear cover, in accordance with one embodiment. FIG. 3 shows the film 130 , a positive mold 110 , decorative elements 302 and a perforated flat element 202 . The decorative elements 302 may be beads, cylindrical elements or any items of any shape that add a decorative element to the decorative ear cover. The positive mold 110 is placed on top of the flat element 202 , the decorative elements 302 are placed on top of the mold 110 , and the film 130 is formed on top of the mold 110 , using the vacuum forming machine 102 as described above. This forms the decorative ear cover to reflect the contours and shape of the mold 110 and decorative elements 302 . In one alternative, at this juncture, one or more paints, fabrics, glitter, or decorative elements are applied to the decorative ear cover. [0032] Subsequently, in one alternative, an additional film 139 is formed over or on top of the first film 130 of the decorative ear cover, so as to create a decorative ear cover with multiple layers. [0033] FIG. 4 is an illustration of several embodiments 402 , 404 of custom fit decorative ear covers, in accordance with one embodiment. The custom fit decorative ear covers 402 , 404 show that the custom fit decorative ear covers include impressions 412 and 414 resulting from the use of at least four decorative elements 302 . FIG. 5 is an illustration of several embodiments 502 , 504 of custom fit decorative ear covers, in accordance with one embodiment. The custom fit decorative ear covers 502 , 504 show that the custom fit decorative ear covers include impressions 512 and 514 resulting from the use of the decorative elements 302 . Two decorative elements are used in cover 502 and four decorative elements are used in cover 504 . [0034] FIG. 6 is an illustration of a custom fit decorative ear cover 402 before placement on the ear 612 of a consumer 602 , in accordance with one embodiment. FIG. 7 is an illustration of a custom fit decorative ear cover 402 after placement on the ear 612 of a consumer 602 , in accordance with one embodiment. As can be seen in FIG. 6 , a consequence of the use of the custom molding procedure is that the decorative ear cover 402 is shaped to fit exactly the contours and surfaces of the consumer's ear 612 , and therefore the decorative ear cover 402 is shaped to fit securely over the consumer's ear 612 , while allowing the decorative ear cover 402 to be easily and quickly removed and re-attached. [0035] In one embodiment, the use of the system and components described in FIGS. 1 and 2 can be replaced with the use of a 3D scanner and printer to create the negative mold, the positive mold 110 and/or the decorative ear covers 402 , 404 , 502 , 504 . A 3D scanner is a device that analyzes a real-world object or environment to collect data on its shape and possibly its appearance (i.e. color). The collected data can then be used to construct digital, three dimensional models. Additive manufacturing or 3D printing is a process of making a three-dimensional solid object of virtually any shape from a digital model. 3D printing is achieved using an additive process, where successive layers of material are laid down in different shapes. 3D printing is considered distinct from traditional machining techniques, which mostly rely on the removal of material by methods such as cutting or drilling. In one embodiment, the 3D scanner is used to scan the user's ear. Next, the 3D printer is used to generate the negative mold, the positive mold 110 and/or the decorative ear covers 402 , 404 , 502 , 504 . [0036] While certain embodiments of the invention have been described, other embodiments may exist. Although the subject matter has been described in language specific to structural features, it is to be understood that the subject matter defined in the appended claims is not necessarily limited to the specific features or acts described above. Rather, the specific features and acts described above are disclosed as example forms of implementing the claims. Although specific embodiments of the invention have been disclosed, those having ordinary skill in the art will understand that changes can be made to the specific embodiments without departing from the spirit and scope of the invention. The scope of the invention is not to be restricted, therefore, to the specific embodiments. Furthermore, it is intended that the appended claims cover any and all such applications, modifications, and embodiments within the scope of the present invention.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates to orthopedic appliances and in particular to deformable splints for application to the elbow, hand or knee of a human patient to achieve a gradual, controlled extension of the limb to which it is applied. 2. State of the Prior Art Persons debilitated by old age or chronic illness, particularly those bound to a wheelchair or bedridden, develop a tendency to retract their limbs to a persistently contracted condition. The arm, leg and hand are all susceptible to this affliction. An accepted treatment for this condition is for a physical therapist to exercise the affected limb by flexing the pertinent joint through the range of motion possible under the circumstances, and applying light force to extend the limb slightly beyond the existing range of motion. The exercised limb is then fixed at the maximum achieved extension by means of an orthosis, or splint, which bridges the joint being exercised and prevents its retraction. This procedure is repeated during successive therapy sessions, over a period of weeks, to achieve a progressive extension of the limb. The orthosis is adjusted following each session to prevent the limb from retracting beyond the maximum extension gained during the particular session. The nearest pertinent prior art is believed to be described in U.S. Pat. No. 5,248,292 issued to Holland, which discloses a static orthosis for use similar to the orthosis of this invention. Briefly, the Holland orthosis consists of a deformable unitary body having two pads connected by a spine. The unitary body is made up of an aluminum endoskeleton which is deformable by means of sufficient manual force and retains a desired shape when so deformed. The endoskeleton is molded in a closed cell polyethylene foam matrix. A unitary cover has pockets connected by a spine strap. Each pocket receives one of the end pads of the unitary body. A number of straps on the cover serve to attach the cover and the unitary body to the limb of the patient. The Holland device suffers from a number of shortcomings. The removable cover does not entirely enclose the deformable unitary body, leaving exposed portions of the unitary body including edges which can press into the skin and tissues of the patient. This requires that the foam matrix around the aluminum endoskeleton provide cushioning. The exposed unitary body comes into contact with the patient and therefore must be periodically washed and cleaned, since the splint is worn for extended periods of time, often several weeks. The straps used to secure the splint to the patient's limb are attached directly to the unitary body, and are separate from the cover. Removal and reinstallation of the straps is needed for washing, adding complexity to the use of the device and exposing the straps to possible misplacement and loss. Improved deformable static orthoses are needed featuring greater comfort and ease of use and maintenance. SUMMARY OF THE INVENTION The present invention addresses the aforementioned need by providing an improved orthosis for application to a joint of an anatomical limb. The improved orthosis has an insert with a semi-rigid stiffener deformable by application of manual force, the stiffener having first and second end plates joined to each other by a narrower intermediate strip, and opposing sheets of pliable material bonded to each other and defining a contour of the insert, such that the stiffener is completely contained between the opposing sheets. A removable cover of launderable fiber material is generally fitted to the contour of the insert. The cover has an interior accessible through a zippered opening for receiving the insert, so that the insert is fully enclosed and covered by the removable cover. A number of retaining straps are spaced apart on the cover and extend transversely to the intermediate strip of the insert for encircling the limb to which the orthosis is applied. The stiffener is preferably metallic, such as of a soft steel, and the end plates are more readily deformable than the intermediate strip. The end plates may be of sheet metal such as a mild steel and the intermediate strip is desirably of thicker metal than the end plates. The end plates may be portions of a single metallic sheet which integrally includes a narrower mid-portion defining the intermediate strip, and the intermediate strip includes a reinforcing strip secured for increasing the stiffness of the mid-portion. The reinforcing strip may be narrower than the mid-portion, and the reinforcing strip may be welded to the mid-portion with welding material applied to define a tapered transition in thickness between the combined thickness of the reinforcing strip and the midportion, and the thickness of midportion alone. Alternatively, the end plates may be discrete metallic plates and the intermediate strip a metallic strip of greater stiffness than the discrete metallic plates. The opposing sheets of the insert are desirably adhered directly to the metallic stiffener, and the opposing sheets may be of uniform thickness and foamed synthetic material. The outer covering is preferably made of terry-cloth material, which can be provided with compressible padding extending over at least one side of the insert, so that the opposing sheet do not need to provide significant cushioning. The covering may have two opposite sides, the zippered opening being on one of the opposite sides, and the other of the opposite sides being padded with cushioning material. The zippered opening preferably extends substantially the entire length of the cover in the direction of the intermediate strip. The insert preferably has a longitudinal axis along the intermediate strip and each of the end plates and the contour defined by the opposing sheets is symmetrical about the longitudinal axis, such that the orthosis is ambidextrous for application to either a right hand or a left hand limb. Each of the retaining straps may have hook and loop fasteners for securing each of the straps in encircling relationship with the limb to which the orthosis is applied. Each of said retaining straps may have an outer covering and an interior strip of compressible but non-stretchable padding material. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a top perspective view of a hand splint according to this invention, shown in an initial planar configuration; FIG. 2 is an exploded view of the hand splint of FIG. 1, showing the bottom side of the cover unzipped for access to its interior and the deformable insert in position for placement in the cover; FIG. 3A shows a first type of construction of the metallic stiffener of the deformable insert; and FIG. 3B shows a second type of construction of the metallic stiffener of the deformable insert; FIG. 4 is a sectional view of the assembled splint taken along line 4--4 in FIG. 1; FIG. 5 shows the bottom side of the cover zipped closed; FIG. 6 is a view as in FIG. 1 showing the hand splint bent to a typical operative configuration; FIG. 6A is perspective view of the deformable insert of the hand splint bent to the operative configuration of FIG. 6; FIG. 7 is a right side view of the hand splint of FIG. 6 applied to the hand of a patient; FIG. 8 is a left side view of the hand splint of FIG. 7; FIG. 9 is a perspective view of a finger separator accessory for use with the hand splint of FIGS. 1 through 8; FIG. 10 illustrates typical installation and use of the finger separator of FIG. 9 with the hand splint applied as in FIG. 7; FIG. 11 shows an elbow splint according to this invention, applied to the elbow of a patient; FIG. 12 is a perspective view of the proximal side of an elbow or knee splint, bent to a typical shape for application to the elbow of a patient as in FIG. 11 or a knee as in FIG. 14; FIG. 13 a shows the insert and cover of an elbow or knee splint, in original planar condition; and FIG. 14 illustrates application of the knee splint according to this invention to the knee of a typical patient. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS With reference to the accompanying drawings, FIG. 1 shows a deformable static orthosis or splint, generally designated by the numeral 10, which by way of example is a hand splint adapted for application to the hand, wrist and forearm of a human patient. FIGS. 2 through 9 further illustrate the hand orthosis. The invention is not, however, limited to hand orthosis and the improvements described herein are equally applicable to elbow and knee splints, such as are shown in FIGS. 11 through 14. The hand splint 10 in FIG. 1 has two pads, including a front pad 12 and a rear pad 14, which are joined by a narrower waist section 16, arranged along a longitudinal axis which traverses all three portions of the splint. The splint further has a proximal side 18 which is applied against the limb of the patient, and an opposite, distal side 20, seen in FIGS. 4, 5 and 6, which faces away from the same limb. Turning to FIG. 2, it is seen that the orthosis 10 includes an exterior cover 22 and a deformable inner 24. The cover 22 has a zippered opening 25 on the distal side 20 which extends nearly the entire length of the cover. Three retaining straps 26a, 26b and 26c each have one end attached to the distal side of the cover at spaced apart locations along the length of the cover. The deformable inner 24 is made up of a stiffener 28, seen in phantom lining in FIG. 2, which is entirely contained or laminated between two relatively thin opposing sheets 30 of foamed synthetic material, as shown in FIG. 4. The stiffener 28 has two end plates, front end plate 32 and rear end plate 34, joined to each other by a narrower midportion 36. FIGS. 3A and 3B show alternate forms of the stiffener 28. In FIG. 3A the end plates 32, 34 and the midportion 36 are portions of a single plate 40 of uniform thickness. A reinforcing strip 42 is affixed longitudinally along the midportion 36. The plate 40 and strip 42 are of a mild steel and the plate is such that it can be bent by moderate manual force. The reinforcing strip is chosen to substantially increase the stiffness of the plate 40 along its midportion 36. The result is that the end plates can be bent in a direction transverse to the length of the stiffener with less effort than required to bend the stiffener along its midportion. A similar result is obtained in the stiffener 28' of FIG. 3B where separate end plates 32', 34' are connected by a connecting strip 44 of heavier gauge than the end plate material. In the insert of FIG. 3A the reinforcing strip is welded to the plate 40 with a substantially continuous bead of solder or weldment material 45 extending about the four sides of the strip 42. The bead 45 is applied so as to form a tapering transition between the greater thickness of the reinforcing strip and the thickness of the plate 40 around the strip. The tapering transition of bead 45 eliminates a sharp edge around the strip 42 which might press against the skin of the user even through the layers of a foam sheet 30 and the cover 22 and be injurious or uncomfortable to the patient. The foamed sheets 30 are oversized with respect to the stiffener 28 and define a contour of the inner 24 which generally follows the contour of the stiffener 28, so as to define two end pads, front end pad 46 and rear end pad 48 connected by a narrower intermediate portion 50. The front end pad 46 has side wings 52 extending in opposite directions transversely to the longitudinal dimension of the inner 24, corresponding to wings 49 on the front plate 32 and 32' of the stiffener. The cover 22 is made of launderable and moisture absorbent terry-cloth fabric, preferably of natural cotton fiber, which entirely covers and contains the deformable inner 24. The cover 22 generally conforms to the perimeter and both sides of the inner 24. The inner 24 is inserted through the zippered opening 24 so that the front end pad 46 fits into the front pad 12 of the cover and the rear end pad 48 fits into the rear pad 14 of the cover. The midportion of the inner is contained by the waist portion 18 of the cover. The assembled splint 10, with the inner 24 inserted into the cover 22 and the zippered opening 25 closed, is seen in FIG. 5. The inner 24 is in an initially planar condition as shown in FIG. 2, and is fitted to a particular patient by bending in both longitudinal and transverse directions, as suggested in FIG. 6A, to the contour of the limb to which it is to be applied. The inner 24 retains the shape to which it is formed and imparts a similar shape to the cover as in FIG. 6. Fitting of the splint 10 is normally done with the inner 24 contained inside the cover 22. Typically the proximal side 18 of the splint 10 will have a concave curvature at the end pads 12, 14 in a transverse direction and a convex curvature along the waist portion 18 in a longitudinal direction of the splint. The hand splint 10 is applied as shown in FIGS. 7 and 8. The proximal side 18 of the splint is applied against the underside of the patient's arm A such that the front end pad 12 supports the fingers of the hand, the rear end pad 14 lies against the forearm, and the waist 18 lies under the wrist. The splint 10 is secured to the arm A in this position by wrapping each of the three retaining straps 26a-c around the forearm and hand and securing the free end of each strap to the distal side 20 of the cover by means of mating hook and loop fasteners 54, 56. As therapy progresses, the curvature of the waist portion 18 is gradually reduced to achieve extension of the hand and wrist from an initially retracted condition. The materials of which stiffener 28 is constructed are chose so that the stiffener, and consequently the splint 10, can be formed to the desired shape by deliberate manual force applied by a therapist, but yet will resist forces to which it is normally subjected when worn by a patient. Neither the opposing sheets 30 nor the cover 22 contribute materially to the stiffness, i.e. resistance to deformation, of the splint 10. The terry cloth cover 22 of splint 10 is padded on the proximal side 18 by a layer of compressible synthetic foam 58 contained between a outer sheet 60 of terry cloth cover material and an inner liner 62 which is also of similar terry cloth fabric. The three layers 60, 58, 62 extend over the entire proximal side 18 of the cover and are sewn together along the perimeter 64 of the cover. The foam padding 58 cushions contact of the patient's arm against the relatively firm inner 24, and particularly contact against the edges of the opposing foam sheets 30 which if unprotected would tend to cause some discomfort to the patient when firmly applied against the limb for extended periods of time. Each of the retaining straps 26a-c are made of the same terry-cloth fabric as the cover 22, and is padded with a strip of resilient compressible non-stretchable synthetic foam which extends substantially the entire length of the strap and is entirely wrapped and covered by the terry-cloth fabric. The terry-cloth covering of retaining strap 26a is partially broken away in FIG. 6 to illustrate the foam strip 27. The foam strip is made non-stretchable by virtue of a mesh 29 of inelastic fiber bonded to one longitudinal surface of the strip. Such foam material is a commercially available product. The same padding is provided in each of the straps 26b and 26c. The padded retaining straps further reduce the likelihood of injury or discomfort to the patient when the splint is properly applied by a skilled therapist. It will be appreciated that the cover 22 and retaining straps 26a-c are permanently secured together as a unit which can be easily separated from the inner 24 and washed, cleaned or laundered without concern with separation or loss of the straps apart from the cover. The synthetic foam surfaces of the inner 24 can also be easily cleaned or sanitized by methods appropriate to synthetic foam materials apart from the textile fabric of the cover 22. After cleaning the cover and inner are assembled quickly and easily, as already described. The side wings 52 of the inner 24 extend into corresponding lateral extensions 15 formed in the cover 22, which are typically bent upwards from the proximal side 18 of the splint, as best understood from FIGS. 6 and 6A. The side wings 52 are deformed to the desired position while inside the cover 22, as in FIG. 6. The inner 24 is shown outside the cover in FIG. 6A for purposes of explanation only. The lateral extensions 15 constitute thumb extenders which serve to separate and extend the patient's thumb T away from the fingers F, as best understood by reference to FIG. 8. The position of the thumb extenders 15 can be gradually adjusted during the course of therapy to achieve gradual extension of the thumb. The hand orthosis 10 is bilaterally symmetrical about a longitudinal axis dividing the front, rear and midportion of the splint. This symmetry makes the splint 10 ambidextrous, i.e., permits the hand splint to be applied equally to the right or the left hand of a patient, and eliminates the need to purchase and maintain stocks of separate right and left hand orthoses, with consequent reduction in administrative costs and improved efficiency of health care institutions where such splints are used. In particular, each splint has a left and a right side thumb extender 15, symmetrically disposed about the imaginary longitudinal axis, only one of which is used for a particular hand of the patient. FIG. 9 shows an accessory finger separator 70 for use with the hand splint 10. The finger separator 70 has an upper portion 72 of terry cloth fabric folded and sewn to make three upright partitions 74. The opposite ends of the terry cloth upper are connected by an elastic band 76. The separator 70 is fitted onto the splint so as to encircle the front pad 12, as depicted in FIG. 9, such that the terry cloth upper 72 extends across the proximal side of the front pad and the elastic band 76 is stretched over the distal side of the front pad. The separator 70 is held on the splint 10 by elastic tension of the band 76. The fingers F of the patient are spaced from each other by the three partitions 74, each partition being inserted between each pair of adjacent fingers. Separation of the fingers is desirable in some cases to prevent deformations, ulcerations and other disease processes of the skin and joints when a patient's fingers are pressed together for extended periods of time. The separator 72 is typically positioned forwardly of the thumb extenders 15 and forwardly of the front retaining strap 26c. However, the actual position of the separator 70 on the splint is easily adjusted, forwardly and backwardly as well as side to side, on the front pad 12, for optimum positioning as required by the shape, size and condition of the individual patient's hand. The ability to install or entirely remove the finger separator 70 on a hand splint 10 gives the therapist flexibility during the course of therapy while minimizing the cost of providing a finger separator when needed on an existing hand splint. FIGS. 12 and 13 show a splint 80 which is shaped for use as an elbow or knee splint. The construction of splint 80 is similar to that of the hand splint 10 explained above, in that splint 80 also has a deformable inner contained and fully enclosed in a terry cloth cover, and numerals in FIGS. 11 through 14 designate features denoted by like numerals in FIGS. 1 through 8. The elbow and knee splint 80 differs from hand splint 10 in that no thumb extenders are needed nor provided, and the two end plates of splint 80 are similar to each other, so that splint 80 is not only bilaterally symmetrical about a longitudinal axis but also symmetrical about a line transverse to the waist of the splint. As further shown, especially in FIGS. 11 and 14, the knee and elbow orthosis are symmetrical about the center strap 26b, i.e. about a line bisecting the orthosis transversely to the elongated midportion. In general, the straps of the orthosis 80 are seen to be symmetrical about a center line transversely dividing the orthosis. As a result of this two-way symmetry of the orthosis 80, the orthosis can be flipped end for end on a particular limb with no change in effectiveness of the orthosis, and furthermore may be used on either a right or a left limb with equal effectiveness. This capability greatly facilitates application of the orthosis by untrained personnel frequently found in old age homes and similar facilities where such orthosis are widely needed and used. The central retaining strap 26b is bifurcated at 82 to wrap on either side of the elbow E or knee K, as shown in FIGS. 11 and 14 respectively where the bony protuberance of the knee and elbow is received in the opening defined by the bifurcation and projects through the strap, in effect serving to hold the strap against easy sliding along the limb. The splint 80 is made in different sizes, a smaller size for application to the elbow and a larger size for the knee. The difference between the elbow and knee splints is however one of scale only. In FIG. 13 the cover 22 is shown open along its zippered opening 25 and the deformable stiffener is shown in its initial flat, planar condition and removed from the cover. In FIG. 12 the splint 80 is shown assembled and formed to a shape appropriate for application to a knee or elbow of a patient. The several advantages and improvements described in connection with the hand splint are equally featured in the elbow and knee splint 80, including provision of padding integral to the removable cover and permanent attachment of the retaining straps to the same cover. The construction of the inner is similar as is the construction of the stiffener of the inner. While a preferred embodiment of the invention has been described and illustrated for purposes of clarity and example, it should be understood that many changes, substitutions and modifications to the described embodiment will be apparent to those possessed of ordinary skill in the art in light of the foregoing disclosure without thereby departing from the scope and spirit of the present invention which is defined by the following claims.

1a

CROSS REFERENCE TO RELATED APPLICATION None BACKGROUND OF THE INVENTION This application relates generally to portable rest or sleeping surfaces and, more particularly, to a lightweight, portable, padded mat that is impervious to fluids and to invasion by infectious organisms and vermin and a method for making the same. Rest or sleeping mattress or mats are known to the art. Generally speaking, such known mats are comprised of an outer cover around a filler or padding. In most instances the prior are expedients have filler or padding of cotton batting, foam or the like and a fabric or plastic cover. The covers of the prior art mats generally are stitched and secured around the filler. It will be appreciated by those skilled in the art that a stitched fabric cover provides innumerable portals of entry for infections organisms, such as bacteria, or vermin such as head lice or scabies, both through the weave of the fabric and through the stitch holes. Furthermore, a cover made from a material with limited portals of entry, such as plastic, which has stitched seams still presents an unacceptably high number of sites accessible by fluid, bacteria or vermin. Furthermore, such stitched mattresses have threads that fray and pull loose and also include rough seams and sharp corners that are unacceptable on mats used by children. A number of prior art expedients have been offered in an attempt to limit contamination of such sleeping or rest mats and mattresses by bacteria or vermin. For example, U.S. Pat. No. 1,371,919, to Mahoney, provides a vermin proof combined mattress and spring; U.S. Pat. No. 4,539,057, to Ahim, provides a method of making a protective layer of film to protect a mattress from injurious substances and bacteria; U.S. Pat. No. 5,007,123, to Salyards provides a flexible covering for reducing moisture and bacteria in a mattress; and, U.S. Pat. No. 5,265,294, to McClure et al. discloses a mattress having a seamless, impermeable PVC cover. The prior art mattresses and covers have several drawbacks. For example, the patents either disclose large full sized mattresses or simply coverings for mattresses. It will be appreciated that full sized mattress are not particularly lightweight or portable or easily used by children. The prior art designs do not lend themselves to convenient storage and occasional use, for example, for convenient storage in a child-care center and occasional use by children for rest or nap. Furthermore, the use or application of a separate, bacteria or vermin resistant cover to a rest or nap cot is impractical. The process is time consuming, requires additional storage space, and requires the maintenance and disinfection of both the cot and the cover. Moreover, the production of a full sized mattress with a totally seamless surface can be quite costly. Therefore, it would be advantageous to have a padded, foldable and portable infection resistant mat for use in the child-care environment, for example, that is durable and relatively simple and economical to construct, lightweight and easy to use. SUMMARY OF THE INVENTION It is among the several objects of the present invention to provide a padded mat that is resistant to invasion by infectious organisms and vermin. Another object of the present invention is to provide such a mat that is lightweight and portable. Another object of the present invention is to provide such a mat that is segmented for folding to allow convenient storage. Still another object of the present invention is to provide such a mat that has a cover that is sealed in such a manner that it does not create portals of entry for infectious organisms, vermin, or body fluids. Another object of the present invention is to provide such a mat that has seams with no sharp edges and no sharp corners. Still another object of the present invention is to provide such a mat that has seams that are sealed by radio frequency (RF) welding techniques which satisfy the aforestated objects. Yet another object of the present invention is to provide such mat that is easily and economically manufactured, convenient to use, and well suited for its intended purposes. In accordance with the invention, generally stated, an infection resistant mat is provided having individual segments containing foam padding and a contiguous cover of impervious material. The cover is constructed by radio frequency (RF) sealing of the seams which eliminates portals of entry for infectious organisms, vermin or body fluids. Air channels communicate between the segments to allow pressure equalization among the several segments during use. The RF sealed seams eliminate sharp edges and sharp corners. The individual segments allow the mat to be folded for convenient storage. The mat also can be constructed with only one padded segment. The mat can be constructed with the cover having the resting surface of one color and the floor-contacting surface of a contrasting color so that the resting surface always is turned up to avoid contamination. The materials are fire retardant and easily cleaned. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is an isometric view of the portable, infection resistant mat of the present invention; FIG. 2 is a top plan of the portable, infection resistant mat of the present invention; FIG. 3 is a side elevation view thereof; FIG. 4 is a side elevational view of the portable, infection resistant mat of the present invention, partially folded for storage; FIG. 5 is a cross-sectional view of the portable, infection resistant mat of the present invention taken along line 5 — 5 of FIG. 2; and FIG. 6 is a cross-sectional view of the portable, infection resistant mat of the present invention taken along line 6 — 6 of FIG. 2 . Corresponding reference numerals indicate corresponding elements throughout the various drawings. DETAILED DESCRIPTION OF THE INVENTION The portable infection resistant mat of the present invention is indicated generally by reference numeral 10 in the drawings. Mat 10 , as illustrated, includes a cover 12 and around an inner padding 14 (FIG. 5 ). Mat 10 can be of any size, however, a size convenient for use by children in a day care environment is preferred. For example, mat 10 can range in dimension from 19 inches by 46 inches to 24 inches by 48 inches. Of course, the mat 10 can be much wider and much longer for use by an adult. The detailed description of the elements and manufacture of mat 10 now will be described in greater detail. Cover 12 of mat 10 preferably is constructed from a material which is fire retardant and durable, such as approximately 10 mil to approximately 20 mil super strong vinyl. The cover material also is easy to clean and to disinfect. Most important, however, is the fact that cover 12 is impervious to liquids, such as urine or other body fluids, and also is impervious to disease causing bacteria and impervious to vermin, such as head lice. The cover 12 of mat 10 includes a top sheet 16 and a bottom sheet 18 . It will be appreciated that the top sheet 16 and the bottom sheet 18 are constructed from contrasting color materials so that the bottom sheet 18 , which has contact with the floor, for example, is always placed on the floor and is not used as a resting surface (FIG. 3 ). Thus, the sleeping side of mat 10 is distinguished from the floor side, providing more sanitary conditions of use. As best seen in FIGS. 1-4, mat 10 is divided into segments, 10 A, 10 B and 10 C. It will be appreciated that mat 10 can include more than three segments or fewer than three segments, depending upon the desired length of the mat. The segmented mat allows the mat 10 to be folded for storage, as shown partially folded in FIG. 4 . The top and bottom cover sheets are sealed along the seams S by radio frequency (RF) welding, as will be explained in greater detail below, to form a contiguous cover. However, at this point it will be noted that the cover sheets are welded together between the segments, to create thin, flexible hinge areas 20 and 22 , for example, which facilitate folding. Of course if mat 10 had more segments it also would include additional hinge areas. Referring to FIGS. 2 and 6, it will be noted that when the hinge areas 20 and 22 are sealed by RF welding, discrete areas are not welded, thereby creating air passageways 24 and 26 . Air passages 24 and 26 allow for air flow between the various segments, thus equalizing pressure within the various segments when a user lays on the mat, providing a more comfortable mat. Air passages made by this method do not require hard inserts or tubing and thus are more comfortable. Referring to FIG. 2, it will be noted that the novel RF welding technique used to produce mat 10 produces seams S without stitch holes, thus eliminating another site of bacterial contamination and does not have threads that can unravel. Furthermore, the manufacturing technique yields a mat 10 having rounded corners C, which is important for mats used by small children. Each segment of mat 10 includes padding 14 . Padding 14 preferably is a polyurethane foam of an appropriate thickness, preferably between ½ inch and 3 inches, most preferably 1 to 2 inches. The thickness of padding 14 should be sufficient to provide a padded, comfortable rest surface if mat 10 is placed directly on a floor. The mat 10 of the present invention generally is manufactured and constructed by the following steps: Two aluminum bottom nests are attached to an aluminum turntable on a radio frequency (RF) vinyl welding machine; A top sealing brass die is attached to a top heated platen on the RF welding machine; A “distance down” limiting switch is set for the height of the die; Copper outside RF shields are set for the down stroke of the brass die; A bottom limit switch is set for the lowest level for the brass die; The power level is set for the RF power to the specific die used for sealing on the production run; The pre-seal time, seal time and cool down time are set on the RF welding machine based upon the thickness and type of vinyl used for the cover; The lower and upper plate current and power settings are sent on the RF welding machine; The skip switch is set on the “on” position on the turntable drive; The operation switch on the control panel is set to “Semiautomatic”; A sheet or piece of cover vinyl is placed on one of the bottom aluminum nests so that it completely covers the aluminum; On one end of the vinyl sheet appropriate tags are positioned under the vinyl on the aluminum nest; The foam padding is appropriately positioned on the vinyl and centered inside the aluminum bottom nest; One sheet or piece of vinyl is placed on top of the foam, completely covering the bottom pieces of vinyl; The start button is activated on the RF welding machine; the turntable rotates 180 degrees and then stops; the RF welding machine upper platen compresses down on the foam and vinyl; after settling for approximately 3 seconds, the RF power is applied and the two sheets of vinyl are welded together at their peripheral edges under the brass die and completely sealed; The turntable rotates again and a completely sealed mat rotates out of the RF welding machine; An operator picks up the mat and places it on an inspection table; The operator pulls off any excess vinyl. On the outside seam is a tear seal that allows the vinyl to pull of cleanly. The excess vinyl is recycled; The mat is inspected to see that all seams are completely sealed with no foam caught in the seal or any defects in the vinyl; and The mat is place in a shipping box for shipment. It will be appreciated by those skilled in the art that various changes and modifications can be made in the mat of the present invention without departing from the scope of the appended claims. Therefore, the foregoing description and accompanying drawings are intended to be illustrative only and should not be construed in a limiting sense.

1a

This application claims benefit of provisional application 60/077,876, filed Mar. 13, 1998. BACKGROUND OF THE INVENTION 1. Field of the Invention The invention relates to compounds, compositions and methods for inhibiting (preventing and treating) neovascularization (angiogenesis). 2. Prior Work Malignant neovascularization (angiogenesis), particularly ocular neovascularization associated with macular degeneration, diabetic retinopathy and retinopathy of prematurity, as well as psoriasis, rheumatoid arthritis and solid tumors, is a serious medical condition. The most common cause of blindness in Americans over age 55 is age-related macular degeneration (AMD); for those under 40, diabetes is the most common cause of blindness. Neovascularization is the root cause of blindness in both cases. Neovascularization is the result of a compromise of the vascular bed supplying the retina, and may be regarded as a response to tissue ischemia (or hypoxia). Clinicians have long recognized the high probability of neovascularization in individuals who have lost part of the capillary bed due to diabetes, or who have experienced occlusion of a branch vein of the retina. The primary current treatment for neovascularization is destructive. Photocoagulation is used to reduce the volume of hypoxic tissue in diabetic retinopathy or to destroy vessels in AMD. Cryotherapy may be used to destroy hypoxic retina in infants. There is an urgent need for therapeutic intervention in these disease processes. No known therapeutic treatment can prevent neovascularization following loss of capillaries in diabetes, reduce the risk of further neovascularization in wet AMD, or offer reassurance to patients at risk because of heredity, diabetes, or age. Any progress toward therapeutic management and prevention of neovascularization will greatly reduce the social and economic impact of diabetes and AMD. One of the limitations of the newer therapeutic approaches to neovascularization that are under development, particularly those involving growth factors, is that they may also inhibit wound repair or the development of collateral vessels in mild occlusion of coronary arteries. STATEMENT OF THE INVENTION It has now been found that certain simple chemical agents, referred to herein as nitrone-related therapeutics or “NRTs”, when administered to a patient susceptible to angiogenesis, can intervene and inhibit its progress. In one aspect this invention provides a method for inhibiting angiogenesis in a patient susceptible thereto by administering to that patient an effective angiogenesis-inhibiting dose of one or more NRTs. In a second aspect, this invention provides pharmaceutical compositions for use in such methods of treating. These compositions include one or more NRTs in a pharmaceutically acceptable carrier. In a third aspect, this invention provides NRTs useful in these compositions and therapeutic methods. DETAILED DESCRIPTION OF THE INVENTION BRIEF DESCRIPTION OF THE DRAWINGS This invention will be further described with reference being made to the accompanying drawings in which: FIG. 1 is a depiction of the chemical structures of ten NRTs preferred for use in the practice of the invention; FIG. 2 is a series of bar graphs illustrating the effect of NRTs in preventing lipid peroxidation in bovine retinal homogenates; FIG. 3 is a series of bar graphs illustrating the effect of NRTs in preventing lipid peroxidation in isolated bovine retinal pigment epithelium cells; FIG. 4 is a graph illustrating the degree of corneal neovascularization observed in a lipid hydroperoxide-induced vascular growth experiment in the presence of compounds of the invention and in the absence of such compounds; FIG. 5 is a graph of the concentration of VEGF in the cornea in the presence of lipid hydroperoxide with and without added NRT; and FIG. 6 is a graph of the concentration of VEGF in the retina in the presence of lipid hydroperoxide with and without added NRT. FIG. 7 is a graph of the concentration of tumor necrosis factor alpha in the cornea in the presence of lipid hydroperoxide with and without added NRT; and FIG. 8 is a graph of the concentration of tumor necrosis factor alpha in the retina in the presence of lipid hydroperoxide with and without added NRT. DESCRIPTION OF PREFERRED EMBODIMENTS This Description of Preferred Embodiments is broken into the following segments: The NRTs Pharmaceutical Preparations, Modes of Administration and Dosages Methods of Preparation of NRTs Description of Experiments The NRTs The NRTs which are employed in the practice of this invention are generally classed as spin-trapping agents. They include aromatic nitrones, including the best known nitrone, alpha-phenyl-N-t butyl nitrone (“PBN”) and derivatives thereof; pyrolline N-oxides such as 5,5-dimethyl pyrroline N-oxide (“DMPO”) and derivatives thereof; pyridyl N-oxide nitrones such as alpha-(4-pyridyl-1-oxide)-N-butyl nitrone (“POBN”) and derivatives thereof. Examples of useful materials are described in U.S. Pat. No. 5,622,994 and published PCT application number WO 92/22290, both of which are incorporated herein by reference. Among the NRT materials, aromatic nitrones are preferred. Aromatic nitrones are generally depicted by the formula X—C(R)═N(O)—Y wherein X is an aromatic group, particularly a phenyl group or a phenyl group with at least one and particularly up to about three substituents selected from the following: lower alkyls of from one to about four carbon atoms, which may be linear or branched, and particularly methyls; lower alkenyls; halogens; haloalkyls; hydroxys; primary, secondary and tertiary amines; NOs; amides; lower alkoxyls, of from one to about four carbon atoms and particularly methoxyls; carboxylic acid functionalities, present as free acid —COOH groups or as suitable salts or esters such as lower alkyl esters of from one to about four carbon atoms and particularly methyl esters; sulfur-containing acid functionalities such as sulfates, sulfites and sulfonates, with the sulfates and sulfites being present as free acids or as salts. In this formula R is most typically hydrogen but can also be a lower alkyl, lower alkoxyl or the like, wherein “lower” has the one to four carbon atom meaning set forth above. In this formula Y is most commonly a one to twelve carbon alkyl group which may be straight chain or branched chain and which may be unsubstituted hydrocarbyl or may contain one or more heteroatoms substituents such as oxygen, sulfur, nitrogen or the like. These heteroatoms can be present as substituents in the Y group's main structural chain, for example as ether oxygens. Alternatively, the heteroatoms can be in the form of groups depending from the Y group main chain. Most commonly Y is from about two to about eight carbon atoms in size with no or one hydroxy or alkoxy substituents. Representative Y groups include methyl; ethyl; the propyls including n- and i-propyl; the butyls, especially t-butyl, heteroatom-substituted (such as hydroxy-substituted-) t-butyl and n-butyl; pentyls such as 1,1-dimethyl propyl and n-pentyl; the hexyls, heptyls and octyls. Some of these compounds include sulfate, sulfone, sulfoxide, sulfonamide or carboxylate groups. The sulfate groups can be present in an at least partially protonated acid form as a solid and in solution at low pH conditions. The weaker acid groups, such as carboxylates, are present as acids at somewhat higher pH's. These ionizable acid groups can also exist at higher pHs in an ionized salt form in combination with pharmaceutically acceptable cations. Most commonly, these cations are a monovalent material such as sodium, potassium or ammonium, but can also be a multivalent cation in combination with a pharmaceutically acceptable monovalent anion, for example calcium with a chloride, bromide, iodide, hydroxyl, nitrate, sulfonate, acetate, tartrate, oxalate, succinate, palmoate or the like anion; magnesium with such anions; zinc with such anions or the like. When reference is made herein to these sulfate or carboxylate groups or the like it will be understood to include the acid form as well as these salt forms, unless otherwise expressly stated. Often the salt forms are more stable than the corresponding free acids. Among these acid groups, the simple sodium, potassium and ammonium salts are most preferred with the calcium and magnesium salts also being preferred but somewhat less so. In the case of the other general types of NRTs, such as those based upon POBN or DMPO, the same types of substitutions can be employed as described with reference to the PBN type nitrones. Thus, in summary, the NRTs preferably used in this invention can be selected form the groups of aromatic nitrones of the formula X—C(R)═N(O)—Y, wherein X, R and Y are defined above; PBN derivatives of the formula X—C(R)═N(O)—Y, wherein X is a phenyl or a phenyl with substituents, and R and Y are defined above; DMPO and derivatives thereof of the general formula wherein A and B are each methyls or are each of the substituents listed with reference to the general aromatic nitrone formula; and POBN and derivatives thereof of the general formula wherein Y is as defined above, n is 0 to 4 and R 2 is any of the substituents listed with reference to the aromatic nitrones. A group of most preferred NRTs is depicted in FIG. 1 . These materials include the following compounds which are at times described using the noted compound references: (Compound Number 1) 3,5-dimethyl,4-hydroxyphenyl-N-n hexyl nitrone; (Compound Number 2) 3,5-dimethoxy,4-hydroxyphenyl-N-t butyl nitrone; (Compound Number 3) 2,4-disulfophenyl-N-ethyl nitrone, disodium salt; (Compound Number 4) 2,4-disulfophenyl-N-isopropyl nitrone, disodium salt; (Compound Number 5) 2,4-dihydroxyphenyl-N-t butyl nitrone; (Compound Number 6) 2,4-disulfophenyl-N-n butyl nitrone, disodium salt; (Compound Number 7) 2,4-disulfophenyl-N-1,1-dimethyl,2-hydroxyethyl nitrone, di-sodium salt; and (Compound Number 8) 2,4-disulfophenyl-N-t amyl nitrone, disodium salt. Of these, 3,5-dimethyl,4-hydroxyphenyl-N-n hexyl nitrone is the most preferred at this time. Pharmaceutical Preparations, Modes of Administration and Dosages Pharmaceutical preparations based upon the NRTs include one or more NRT in combination with a pharmaceutically acceptable carrier. The particular carrier employed will depend upon the mode of administration. Our studies provide evidence that the NRTs are effective in the treatment of angiogenesis when administered systemically, such as parenterally or orally. We also have evidence that the NRTs are active against angiogenesis when administered locally such as by intravitreal injection to the eye or topically to the eye via ointments, via eye drops of solutions or suspensions of particles or of liposomes or from a drug-releasing ocular insert. The compositions for oral administration can take the form of bulk liquid solutions or suspensions or bulk powders. More commonly, however, the compositions are presented in a unit dosage form to facilitate accurate dosing. Typical unit dosage forms include prefilled, premeasured ampules or syringes of the liquid compositions or pills, tablets, capsules or the like in the case of solid compositions. In such compositions, the NRT is usually a minor component (0.1 to say 50% by weight or preferably from about 1 to about 40% by weight) with the remainder being various vehicles or carriers and processing aids helpful for forming the desired dosing form. A liquid form may include a suitable aqueous or nonaqueous vehicle with buffers, suspending and dispensing agents, colorants, flavors and the like. A solid form may include, for example, any of the following ingredients, or compounds of a similar nature: a binder such as microcrystalline cellulose, gum tragacanth or gelatin; an excipient such as starch or lactose, a disintegrating agent such as alginic acid, Primogel, or corn starch; a lubricant such as magnesium stearate; a glidant such as colloidal silicon dioxide; a sweetening agent such as sucrose or saccharin; or a flavoring agent such as peppermint, methyl salicylate, or orange flavoring. In the case of injectable compositions, they are commonly based upon injectable sterile saline or phosphate-buffered saline or other injectable carriers (both aqueous and nonaqueous) known in the art. Again the active NRT is typically a minor component, often being from about 0.05 to 10% by weight with the remainder being the injectable carrier and the like. These components for orally administrable or injectable compositions are merely representative. Other materials as well as processing techniques and the like are set forth in Part 8 of Remington's Pharmaceutical Sciences, 17th edition, 1985, Mack Publishing Company, Easton, Pa., which is incorporated by reference. When treating ocular neovascularization conditions, one can also administer the compounds of the invention topically to the eye in the form of an ocularly acceptable eye drop or suspension of particles or liposomes, from ointments or from a suitable sustained release form. Eye drops include a liquid carrier which is typically isotonic and sterile and also includes a suitable preservative and thixotropic material. Representative topical ocular preparations are described in chapter 2 “Pharmacokinetics: Routes of Administration”, pages 18-43, of Ocular Pharmacology, Fifth Edition, William Havener, The C. V. Mosby Company, St. Louis, 1983, which is also incorporated herein by reference. As pointed out there, eye drop formulations may be based on simple aqueous vehicles or may employ more viscous vehicles such as thickened aqueous vehicles or nonaqueous materials such as vegetable oils or the like all with various buffers and salts to adjust the pH and tonicity to non-irritating levels. In these eye drop formulations the NRT can be present as a solute or as a suspension or in the form of liposomes based on phospholipids and the like. Ocular ointments include a gel or ointment base as described in Havener's Ocular Pharmacology. In these topical compositions the amount of NRT will range from about 0.05 to 10% by weight with the remainder being the carrier and the like. Typical concentrations for eye drops are 0.25-2% by weight. When direct delivery of NRT to the eye is desired, it may also be accomplished using sustained release forms or sustained release drug delivery systems. A description of representative sustained release materials such as soft contact lenses, soluble drug inserts and membrane-controlled diffusional systems, can be found in the incorporated materials in Havener's Ocular Pharmacology. The conditions treated with the NRT-containing pharmaceutical compositions may be classed generally as malignant neovascularization (angiogenesis) conditions. These occur with particular severity as ocular neovascularization associated with macular degeneration, diabetic retinopathy and retinopathy of prematurity. Angiogenesis is also observed in psoriasis, rheumatoid arthritis, and solid tumors. Each of these conditions is characterized by a progressive loss of function, such as vision, range of motion or skin integrity. The NRT compounds, when administered orally or by injection such as intravenously, can slow and delay and possibly even to some extent reverse the loss of function. Injection dose levels such as by intravenous administration for treating these conditions range from about 0.01 mg/kg/hr to about 10 mg/kg/hour. Such intravenous therapy might last for from less than a hour to as long as eight hours or more. A preloading bolus of from about 0.1 mg/kg to about 10 mg/kg or more may also be administered to achieve adequate steady state levels. The maximum total dose is not expected to exceed about 2 g/day for a 40 to 80 kg adult patient. Many of the conditions treated are chronic in nature. With these chronic conditions, the regimen for treatment usually stretches over many months or years so oral dosing is preferred for patient convenience and tolerance. With oral dosing, one to five and especially two to four and typically three oral doses per day are representative regimens. Using these dosing patterns, each dose commonly provides from about 1 to about 20 mg/kg of NRT, with preferred doses each providing from about 1 to about 10 mg/kg and especially about 1 to about 5 mg/kg. In the case of treating angiogenesis associated with solid tumors, one can of course use systemic administration as just described. One can also use more localized delivery to the tumor site. This can be accomplished by close intra-arterial delivery where the artery chosen is one delivering blood to the tumor site where the angiogenesis is occurring. In the case of close intra-arterial administration one typically administers doses of up to about 10 mls, e.g. from about 0.25 to about 10 mls, containing from about 0.1 to about 10 and preferably from about 0.5 to about 5 mg/ml of active NRT. In the case of treating angiogenesis associated with solid tumors, the doses of NRT can be delivered daily or more often during the therapy period. One could also administer the active NRT by a continuous pumping into the arterial delivery route or continuously from a depot or other site within or near the tumor. Of course, one can administer an NRT as the sole active agent or one can administer it in combination with other agents, including other active NRTs. Methods of Preparation of NRTs Many of the NRTs employed herein are known compounds which may be purchased or which may be prepared by methods described in the literature. In addition, in the case of the NRTs which are simple nitrones, such as the PBN analogues described above as most preferred materials, these materials can be produced using a two step synthesis. In the first step, a commercially available nitroalkane (wherein the alkane corresponds to the R group present on the nitrogen in the final nitrone functionality) (for example 2-nitropropane or 2-nitrobutane) is converted to the corresponding hydroxylamine using a suitable reagent such as activated zinc/acetic acid, activated zinc/ammonium chloride or an aluminum/mercury amalgam. This reaction can be carried out in 0.5 to 12 hours and especially about 2 to 6 hours or so at a temperature of about 0 to 100° C. in a liquid reaction medium such as alcohol/water mixture in the case of the zinc reagents or an ether/water mixture in the case of the aluminum amalgam reactant. In the second step, the freshly formed hydroxylamine is reacted in slight molar excess with a formyl-substituted aromatic compound which corresponds to the aromatic portion of the desired NRT. If the aromatic portion carries an acid substituent such as sulfonic acid or carboxylic acid functionality, this group will be present in the salt form. The position of the formyl group corresponds to the position of the nitrone in the final product, for example 2,4-dihydroxy benzaldehyde. The number (0, 1, 2 or 3) and position (2, 3, 4, 5, or 6) of the substituents on the aromatic ring corresponds to the number and position in the final product. This reaction can be carried out at similar temperature conditions described with reference to the first step. This reaction is generally complete in 1 to 48 hours and especially 10 to 24 hours. If the product so formed contains a sulfate, carboxylate or the like, such group is typically present as the salt. These salts can be converted to the free acid form by suitable acidification. Other salts can be easily formed by admixing the free acid in aqueous medium with the appropriate base, for example, KOH for the potassium salt, and the like. Description of Examples This invention will be further described with reference being made to the following experiments. These are intended to exemplify preferred aspects of this invention and are not to be construed as limiting its scope. Two in vitro experiments were conducted as Example 1 and 2 to determine whether or not NRTs showed promise as active agents against neovascularization. EXAMPLE 1 In the first test, selected NRTs were tested for their ability to prevent lipid peroxidation of bovine retinal homogenates. Lipid peroxidation was induced by the addition of 2.5 mM Fe +2 . NRTs were added to give concentrations of 10 and 100 μg/ml which is approximately 40-400 μM depending on the molecular weight of the NRT tested. Lipid peroxidation was measured by a TBARs assay. This assay is based on a modification of a fluorescent method reported by Yagi (Biochem. Med. 25:373-378(1981)). Of the eight NRTs tested, all were active as shown in FIG. 2 and in Table 1. EXAMPLE 2 In the second test, selected NRTs were tested to determine their effect on preventing lipid peroxidation of isolated bovine retinal pigment epithelium cells. Lipid peroxidation was induced by the addition of 2.5 mM Fe +2 . NRTs were added to give concentrations of 10 and 100 μg/ml which is approximately 40-400 μM depending on the molecular weight of the NRT tested. Lipid peroxidation was measured by a TBARs assay. This assay is based on a modification of a fluorescent method reported by Yagi (Biochem. Med. 25:373-378(1981)). Of the eight NRTs tested, five were active as shown in FIG. 3 and in Table 1. TABLE 1 Activity of NRTs in In Vitro Assays Testing Ability to Inhibit Lipid Peroxidation Isolated Bovine Retinal Homogenate Bovine Pigment Epithelium Com- Con- Com- Con- pound centration Inhibition pound centration Inhibition 1  10 μg/ml 49% 1  10 μg/ml 82% 100 μg/ml 100%  100 μg/ml 31% 2  10 μg/ml 33% 2  10 μg/ml 31% 100 μg/ml 67% 100 μg/ml 69% 6  10 μg/ml 11% 5  10 μg/ml 19% 100 μg/ml 53% 100 μg/ml 44% 7  10 μg/ml 18% 6  10 μg/ml  5% 100 μg/ml 35% 100 μg/ml 30% 5  10 μg/ml 19% 3  10 μg/ml  0% 100 μg/ml 28% 100 μg/ml 18% 4  10 μg/ml 10% 7  10 μg/ml  0% 100 μg/ml 19% 100 μg/ml  0% 8  10 μg/ml 10% 8  10 μg/ml  0% 100 μg/ml 17% 100 μg/ml  0% 3  10 μg/ml  0% 4  10 μg/ml  0% 100 μg/ml 27% 100 μg/ml  0% EXAMPLE 3 In one animal model for neovascularization, New Zealand white rabbits were treated with lipid hydroperoxide (“LHP”). In comparison to animals not so treated or treated with non-hydroperoxidized lipid (18:1 linoleic acid), these animals develop high degrees of neovascularization in their corneas and retina. A test material's effectiveness is measured by its ability to intervene in the neovascularization event. In one study, neovascularization of the cornea was examined. Vessels in the superior quadrant which were stimulated by LHP served as the positive control. They grew progressively to a mean length of 2.4 mm. There were approximately 20 separate vessels arising from the parent limbal vessels. Multiple branches were observed in this quadrant especially at the distal ends. Vessels in the center were always longer than at the edges. This was because neovascularization is a function of distance between the stimulus and the limbus. Thus, vessels were never observed in the inferior or intermediate quadrants. The controls using nonperoxidized linoleic acid (18:1) were essentially negative for vessel growth. To quantitate the neovascular response, Kodachrome slides taken from each group of animals were projected onto a screen and the entire vascular bed traced with an Opsiometer. This provided a cumulative index of total vessel proliferation at the various time intervals. These results are shown in FIG. 4 . This study showed that Compound 1 was the most effective inhibitor of corneal neovascularization (38% at 3 days, 61% at 7 days, 67% at 10 days and 75-85% at 14 days post-exposure. Compound 6 was also effective; 42% at 4 days, 37% at 7 days 46% at 11 days and 58% at 14 days post-exposure. Compound 2 showed anti-neovascular properties, but was the least effective of the drugs tested (17% at 4 days, 27% at 7 days, 33% at 11 days and 37% at 14 days post-exposure). From analysis of the slope and development of growth curves, it was determined that from 3 days until the end of the experiment, vessel proliferation was stopped completely by Compound 1. At 14 days, there was evidence for vessel retraction (from 7.5 mm to 6 mm). In contrast, vessels from Compound 6- and Compound 2-treated animals continued to grow in length and numbers until 10-11 days post-exposure. Compound 1 and Compound 6 showed the greatest amount of vessel retraction (20 and 23%, respectively). Similar findings were obtained when the retina was examined. New vessels grew extensively in the LHP-treated animals without drug intervention. Numerous small branches were observed proximally and some were markedly dilated. At the distal end of vessels, there was extensive dilation and hemorrhage. In contrast, vessels in control animals injected with 18:1 showed no edema, neovascularization, or hemorrhage. An animal treated with Compound 1 showed a reduction in neovascularization, but only slight effects on dilation and hemorrhage. Vasodilation edema and hemorrhage are prominent in an animal treated with Compound 2, however, no neovascularization was evident. Only dilation is observed in the retina treated with Compound 6. As shown in Table 2, Compounds 1, 2 and 6 all greatly retarded the neovascularization process. The degree of retardation ranged from 87.5% for Compound 2, to 75% for Compound 6, to 62.5% for Compound 1. TABLE 2 Retinal Data Rabbit # CD or CS Treatment Dilation Hemorrhage Neovascularization RD Edema 993 CD LHP - 14d + + + + + CS LHP - 14d + + + − − 994 CD LHP - 14d − − − + + CS LHP - 14d + + + + + 75% 75% 75% 75% 75% 996 CD 18: 1 - 14d − − − − − CS 18: 1 - 14d − − − − − 997 CD 18: 1 - 14d − − − − − CS 18: 1 - 14d − − − − − 977 CD 1 - 7d + + − + + CS 1 - 7d + + + + − 978 CD 1 - 7d + − − − + CS 1 - 7d + − − − − 979 CD 1 - 14d − − − + − CS 1 - 14d − − − − − 980 CD 1 - 14d + + + − + CS 1 - 14d + + + − − 75% 50% 37.5% 37.5% 37.5% 983 CD 2 - 7d − + − + − CS 2 - 7d + + − + − 984 CD 2 - 7d + + + − + CS 2 - 7d + − − − + 985 CD 2 - 14d + + − − + CS 2 - 14d + + − − − 986 CD 2 - 14d − − − − − CS 2 - 14d − + − − + 62.5% 75% 12.5% 25% 50% 989 CD 6 - 7d + + − − + CS 6 - 7d + − + − − 992 CD 6 - 7d + + − + − CS* 6 - 7d + − + − − 990 CD 6 - 14d − − − − − CS 6 - 14d − − − − − 991 CD 6 - 14d + − − − − CS 6 - 14d + + − + − 75% 37.5% 25% 25% 12.5% *keratitis Compounds 1, 2 and 6 showed differing effects on neovascular-associated phenomena in the retina. Vasodilation, hemorrhage, retinal detachment and edema were observed in 75% of the eyes injected with LHP. In contrast, the control vehicle (18:1 linoleic acid) evoked none of these responses in either right (OD) or left eyes (OS). Compounds 1, 2 and 6 were ineffective in controlling dilation or hemorrhage, although Compound 2 reduced the incidence to 37.5%. Retinal detachment was also reduced to a level of 25% by Compounds 2 and 6 and to a level of 37.5% by Compound 1). Retinal edema was reduced to 12.5% by Compound 6, to 37.5% by Compound 1 and to 50% by Compound 2. EXAMPLE 4 An additional study was conducted. This study was based on the suggestion that certain cytokines play a role in the neovascularization process with the concentration of these cytokines being abnormal when the undesirable neovascularization takes place. An effective agent would correct these abnormalities. In one study, the concentration of the cytokine, vascular endothelial growth factor (“VEGF”) was studied. VEGF concentration was measured by immunoassay (R&D Systems Quantkine kit). Measurements were made in control animals, control animals receiving an injection of LHP and test animals receiving LHP plus test compound. Measurements were carried out at the injection site and in the superior quadrant. LHP stimulated the maximum synthesis of VEGF between 6 to 24 hours. a. Cornea Since both areas (injection site and superior quadrant) were decreased in treated animals, the values were added together and averaged. The degree of reduction produced by NRT compounds at 12 hours post-injection of LHP ranged from 55% for Compound 6, to 48% for Compound 1 to 40% for Compound 2. The concentration of VEGF declined further to 50% to 75% levels at 7 days and 14 days. These results are presented graphically in FIG. 5 . b. Retina VEGF was reduced by NRT compounds to a greater extent than observed in cornea. At 12 hours, 7 or 14 days, the difference was 30% greater in the retina (FIG. 6 ). By 14 days post-injection, Compound 1 inhibited VEGF production 92%, Compound 2 inhibited 86% and Compound 6 inhibited 76%. This placed all 3 drugs within the range of control samples. These results are presented graphically in FIG. 6 . c. Tumor necrosis factor alpha (TNFα) addition Measurements of tumor necrosis factor alpha (TNFα) were added to the protocol to obtain a more comprehensive understanding of alterations occurring in the initiation of the angiogenic cytokine cascade. Tissue levels were quantified using a WEH1 cell bioassay which is specific for TNFα. Previous studies in our laboratory have demonstrated that during the first day after LHP exposure, there is a dramatic increase in TNFα and if inhibitors (anti-TNFα or pentoxifylline) are added in vivo, neovascularization is markedly retarded. In the cornea, Compound 2 depressed TNFα levels at 12 hours by 36% and at 7 days was still 25% below LHP control levels. (These results are shown in FIG. 7) Corneal samples at 12 hours from Compound 1 and Compound 6 were contaminated. Compound 1- and Compound 6-treated rabbits had TNFα levels that were increased above the baseline at 7 and 14 days post-injection. In the retina, Compounds 1, 2 and 6 all inhibited TNFα synthesis, with Compound 6 showing the greatest effect at 12 hours post-injection. Compound 2 and Compound 1 appeared to stimulate new synthesis, at 7 days after exposure, and then dropped to low levels, whereas Compound 6 remained near baseline over the 14 days experimental period. (These results are presented in FIG. 8) While early response of TNFα provides localized signals for synthesis of other cytokines to sustain growth and can be considered a pathological event, the increases at 7 days in retina and 14 days in cornea may represent secondary repair process. For example, TNFα may be cytotoxic in one situation and restorative in another. Therefore, repair stimuli may be regulated differently than the initial oxidative stress which initiated neovascularization from the parent vessel. In summary, in this study all three NRT compounds tested showed an inhibitory effect on LHP induced neovascularization in both cornea and retina. As a model for studying diabetic retinopathy, the effect of NRTs in protecting against induction and associated pathophysiologic changes by LHP was important. NRT compounds were observed to affect the synthesis of both TNFα and VEGF which are essential growth factors for the initiation and propagation of new vessels. The collective reduction of these cytokines would be expected to abate the neovascular responses. Retinal neovascular proliferation was reduced best (88%) by Compound 2 with the other two drugs ranging from 63% to 75%. Compound 6 appeared to be more effective against controlling edema, hemorrhage and retinal detachment. These results suggest the efficacy of using NRT compounds in the management of proliferative diabetic retinopathy. Using a more easily visualized corneal model, a marked inhibitory effect was also observed. This, too, was correlated with statistically significant reductions in the cytokine growth factors TNFα and VEGF.

1a

BACKGROUND Procedures requiring the use of peripherally inserted central catheters (“PICC”) often employ pressure activated valves to seal these catheters when not in use. Such pressure activated valves are designed to remain closed during normal pressure fluctuations between uses to prevent leakage and backflow which may lead to occlusions and/or infections. However, these valves have often been unsuitable for the injection of fluids at high pressures or volumes. SUMMARY OF THE INVENTION The present invention is directed to a device for transferring fluids between an internal structure in a living body and an exterior thereof, comprises a housing including a pressure activated lumen extending to a distal end opening to a power injection lumen that extends to a distal port configured for connection to a fluid conduit extending to a target structure within the body and a pressure activated valve extending across the pressure activated lumen and controlling fluid flow therethrough, the pressure activated valve opening to permit fluid flow therethrough into the power injection lumen when a fluid pressure differential thereacross is at least a first predetermined threshold level and remaining sealed when the fluid pressure differential thereacross is less than the first threshold level in combination with a proximal port coupled to the housing for movement between a first position in which a proximal end of the power injection lumen opens to the proximal port and a second position in which a proximal end of the pressure activated lumen opens to the proximal port. The present invention is further directed to a method for transferring fluids between a target internal structure of a living body and an exterior of the body, the method comprising connecting to a proximal end of a fluid conduit extending into the body to the target structure a distal port of a housing opening to a power injection lumen thereof, the housing including a pressure activated lumen extending to a distal end opening to the power injection lumen with a pressure activated valve opening to permit fluid flow therethrough into the power injection lumen when a fluid pressure differential thereacross is at least a first predetermined threshold level and remaining sealed when the fluid pressure differential thereacross is less than the first threshold level and moving a proximal port of the housing to a first position in which the proximal port is fluidly coupled to the power injection lumen in combination with supplying a first fluid to the proximal port at a power injection pressure greater than the first threshold level, moving the proximal port of the housing to a first position in which the proximal port is fluidly coupled to the pressure activated lumen and supplying a second fluid to the proximal port at a pressure greater than the first threshold level and less than the power injection pressure. BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawing illustrates the design of the present invention wherein: FIG. 1 shows a first view of an apparatus according to a first embodiment of the present invention; FIG. 2 shows an exploded view of the device of FIG. 1 ; FIG. 3 shows an internal view of the device of FIG. 1 ; FIG. 4 shows a side view of the device of FIG. 1 ; FIG. 5 shows a bottom view of the device of FIG. 1 ; FIG. 6 shows a top view of the device of FIG. 1 ; FIG. 7 shows a perspective view of the device of FIG. 1 in a position permitting flow through a pressure activated valve; and FIG. 8 shows a perspective view of the device of FIG. 1 in a normal flow position. DETAILED DESCRIPTION The present invention, which may be further understood with reference to the following description and the appended drawings, relates to a system and method for high pressure and high volume injection without damaging a pressure activated valve. In particular, the present invention relates to the selective engagement for high pressure and high volume injection of separate lumens within a device employed in conjunction with a catheter (e.g., a PICC catheter) with at least one of the lumens employing a pressure activated valve. Presently available pressure activated valves are generally unable to sustain the high pressures and flow rates associated with power injection (e.g., of contrast media). An exemplary embodiment of the present invention seeks to alleviate this problem by incorporating with a pressure activated valve a bypass feature allowing power injection without damaging the pressure activated valve. As shown in FIGS. 1-8 , a port 100 according to a first embodiment of the invention includes two passages which may be selectively engaged to select either power injection or standard infusion/withdrawal of fluids. The port 100 comprises a base 110 and a cover 120 joined together, for example, via any known means such as bonding, welding, friction fit, etc. Protruding distally from the port 100 is an elongated tubular body 105 with a lumen 115 extending therethrough and into the base 110 , as will be described in greater detail below. It is noted that the term proximal as referred to herein refers to a direction approaching a user or point of user access to the device while distal refers to a direction toward an interior of the body of the patient. The tubular body 105 is provided with a barbed fitting comprising a series of ridged portions 106 designed to frictionally engage a catheter disposed thereover. Specifically, the ridged portions 106 are formed with a diameter sized to frictionally engage inner walls of a catheter, thereby firmly securing the catheter to the port 100 . Accordingly, to mate to the port 100 , a catheter is guided over the tubular body 105 to a proximal-most position and frictionally retained thereon. In an alternate embodiment, the tubular body 105 may be insert molded on the catheter, as those skilled in the art will understand. As shown in the exploded view of FIG. 2 , a silicone disk 130 is provided in the port 100 , in engagement with a correspondingly sized recess 131 in the base 110 which opens to the lumen 115 . The silicone disk 130 effectively regulates the pressure and flow of fluids passing therethrough the port 100 . As would be understood by those skilled in the art, the disk 130 may be formed in any desired configuration to obtain desired flow configurations. For example, the disk 130 and a slot or slots therethrough may be formed as shown for any of slitted membranes disclosed in U.S. patent application Ser. No. 10/768,571 entitled “Pressure Activated Safety Valve With Anti-Adherent Coating” filed on Jan. 29, 2004 to Weaver, et al. (the '571 app.); U.S. application Ser. No. 10/768,565 entitled “Pressure Activated Safety Valve With High Flow Slit” filed on even day herewith naming Karla Weaver and Paul DiCarlo as inventors, and U.S. application Ser. No. 10/768,629 entitled “Stacked Membrane For Pressure Actuated Valve” filed on even day herewith naming Karla Weaver and Paul DiCarlo as inventors, and U.S. application Ser. No. 10/768,855 entitled “Pressure Actuated Safety Valve With Spiral Flow Membrane” filed on even day herewith naming Paul DiCarlo and Karla Weaver as inventors, and U.S. application Ser. No. 10/768,479 entitled “Dual Well Port Device” filed on even day herewith naming Katie Daly, Kristian DiMatteo and Eric Houde as inventors. The entire disclosures of each of these applications are hereby incorporated by reference in this application. The silicone disk 130 is held in place over the recess 131 via a disk retainer 135 which engages a periphery thereof. When the cover 120 is mounted to the base 110 , a portion of the cover 120 engages the disk retainer 135 applying pressure against the disk 130 to hold the disk 130 against a periphery of the recess 131 and prevent the silicone disk 130 from being moved therefrom. A rotating luer 150 engages a proximal end of the base 110 at a proximal end of the port 100 , as further shown in FIG. 3 . The rotating luer 150 includes a lumen 155 extending therethrough from a proximal end 151 to a distal end 152 and at least two tabs 160 extending therefrom about a circumference of an end plate 158 of the luer 150 which preferably forms a substantially continuous surface with the portion of the port 100 (i.e., proximal ends of the base 110 and the cover 120 regardless of a rotational orientation of the luer 150 . The tabs 160 indicate an alignment of the lumen 155 in relation to the two lumens 115 and 125 of the port 100 , as will be described in greater detail below. The luer 150 also includes a disk-shaped mating projection 156 which is received within a correspondingly shaped and sized slot 154 to rotatably secure the luer 150 to the base 110 . Two O-rings 140 are provided between the rotating luer 150 and the upper and lower body portions 120 , 110 to provide a fluid seal therebetween. However, those skilled in the art will understand that any number of O-rings may be provided in the device and these O-rings may vary in thickness and size to obtain the desired seal. The O-rings may exhibit elastomeric properties and may, in an exemplary embodiment, be received in recesses formed on a proximal faces of the base 110 and the cover 120 around proximal openings to the lumens 115 , 125 , respectively. As shown in FIG. 3 , when in a pressure activated position, the lumen 155 of the luer 150 is aligned with the lumen 125 of the cover 120 which opens to the disk 130 . As would be understood by those skilled in the art, when a pressure differential between the lumen 125 and the lumen 115 exceeds a predetermined threshold, edges of the slit(s) in the disk 130 are moved apart from one another and fluid will flow through the disk 130 into the lumen 115 to a catheter attached thereto. When the pressure differential remains below the predetermined threshold, the disk 130 remains sealed preventing fluid flow from the lumen 115 to the lumen 125 . In order to configure the port 100 in the pressure activated position as also shown in FIGS. 6 and 7 , a user of the port 100 rotates the luer 150 until the tabs 160 are aligned with corresponding projections (e.g., projections 161 ) on the port distal body of the port 100 (i.e., the base 110 and/or the cover 120 ) to an indicated pressure activated position. Specifically, the proximal portion of the port 100 may be labeled to indicate the locations of the lumens 115 and 125 , as shown in FIGS. 5 and 6 . A physician may then rotate the proximal portion of the port 100 to align the tabs 160 with the projections 161 . Rotating the proximal portion of the port 100 in either a clockwise or counter-clockwise direction until the lumen 155 aligns with the desired lumen of the port 100 engages the desired one of the lumens 125 and 115 . It is further noted that, when the tabs 160 are not aligned with the projections 161 , the port 100 is in an off position with both of the lumens 115 and 125 sealed to prevent the flow of fluid into or out of the proximal portion of the device. Once the pressure activated valve has been selected, the flow of fluid through the port 100 is guided through the pressure activated valve, as detailed above, with fluid entering the port 100 through an externally attached fluid source via an attachment means shown at the proximal end 151 of the rotating luer 150 . The fluid flows through the lumen 155 and into the lumen 125 and, when the pressure differential exceeds the predetermined threshold level, past the silicone disk 130 into the lumen 115 via the recess 131 . The fluid is passes through the lumen 115 toward the elongated tubular body 105 as flow toward the proximal end of the lumen 115 is prevented by the fluid-tight seal formed by the distal face of the rotating luer 150 which covers the proximal opening to the lumen 115 when the pressure activated valve has been selected. The fluid flows out of the distal opening of the elongated tubular body 105 to a targeted site in the body via a catheter or other device attached to the tubular body portion 105 as would be understood by those skilled in the art. Alternatively, if the “<5 mL/s” marker is selected, as shown in FIGS. 5 and 8 , the lumen 155 is connected directly to the lumen 115 located inside the base 110 of the port 100 . An external high pressure or high volume fluid source may then be attached to a proximal end of the port 100 so that high pressure and/or high volume fluid (e.g., at flow rates and pressures suitable for the power injection of contrast media) supplied to the port 100 passes directly through the lumen 115 to the distal opening in the body 105 and into the catheter without passing through the disk 130 . It is further noted that the diameter of the lumen 155 may be substantially similar to the diameter of the lumen 115 to allow for an undeterred flow of fluid therethrough. The present invention has been described with respect to particular designs and embodiments. However, those skilled in the art will understand that the described exemplary embodiments of the present invention may be altered without departing from the spirit or scope of the invention. For example, the port 100 may be altered in geometry, with the diameters of the either of the lumens 115 , 125 and 155 increased or decreased to accommodate the requirements of a patient or procedure for which they are intended. Furthermore, a design may be incorporated with each of the lumens 115 and 125 identified by a different color or pattern of colors, eliminating the need for written markings on the outer body of the port 100 . It is to be understood that these embodiments have been described in an exemplary manner and are not intended to limit the scope of the invention which is intended to cover all modifications and variations of this invention that come within the scope of the appended claims and their equivalents. The specifications are, therefore, to be regarded in an illustrative rather than a restrictive sense.

1a

RELATED APPLICATION [0001] This application is a continuation of U.S. patent application Ser. No. 10/156,611, filed May 24, 2002. FIELD OF THE INVENTION [0002] The present invention relates to a shield for a needle and more particularly to a safety shield assembly that may be used in conjunction with a syringe assembly, a hypodermic needle, a needle assembly, a needle assembly with a needle holder, a blood collection needle, a blood collection set, an intravenous infusion set or other fluid handing devices or assemblies that contain piercing elements. BACKGROUND OF THE INVENTION [0003] Disposable medical devices having piercing elements for administering a medication or withdrawing a fluid, such as hypodermic needles, blood collecting needles, fluid handling needles and assemblies thereof, require safe and convenient handling. The piercing elements include, for example, pointed needle cannula or blunt ended cannula. [0004] Safe and convenient handling of disposable medical devices is recognized by those in the medical arts so as to minimize exposure to blood borne pathogens. Safe and convenient handling of disposable medical devices results in the disposal of the medical devices intact. [0005] As a result of this recognition, numerous devices have been developed for shielding needles after use. Many of these devices are somewhat complex and costly. In addition, many of these devices are cumbersome to use in performing procedures. Furthermore, some of the devices are so specific that they preclude use of the device in certain procedures or with certain devices and/or assemblies. For example, some devices employ very short thin needle cannulas. A shield designed to lock near the distal end of one needle cannula might not engage a much shorter needle cannula. Additionally, a shield designed to lock with a wider gauge needle cannula might be more likely to generate a spray upon engaging a much narrower needle cannula. Furthermore, it may be desirable to reduce the force required to effect shielding without reducing the audible and tactile indications of complete shielding. [0006] Therefore, there exists a need for a safety shield assembly: (i) that is manufactured easily; (ii) that is applicable to many devices; (iii) that is simple to use with one hand; (iv) that can be disposed of safely; (v) that does not interfere with normal practices of needle use; (vi) that has tactile features whereby the user may be deterred from contacting the needle, the user may easily orient the needle with the patient and easily actuate and engage the shield assembly; (vii) that has visual features whereby the user may be deterred from contacting the needle, the user may easily orient the needle with the patient and easily actuate and engage the shield assembly; (viii) that is not bulky; (ix) that includes means for minimizing exposure to the user of residual fluid leaking from the needle; and (x) provides minimal exposure to the user because the needle shield is immediately initiated by the user after the needle is withdrawn from the patient's vein. SUMMARY OF THE INVENTION [0007] The present invention is a safety shield assembly that comprises: a shield; means for connecting the shield to a fluid handling device that contains a piercing element, such as needle; means for pivoting the shield away from the needle; means for securely covering and/or containing the needle within the shield and means for securely locking the shield in a final non-retractable closed position over the needle. [0008] Preferably, the shield comprises a rearward end, a forward end, a slot or longitudinal opening for housing the used needle in the forward end, means for securing the needle in the slot, means for guiding the needle into the slot, means for connecting the shield and the fluid handling device, means for guiding the user's fingers to move the shield into various positions, and means for retaining the shield securely over the used needle. [0009] Desirably, the means for connecting the shield to the fluid handling device is a collar. Preferably, the shield is connected movably to a collar which is connected to a fluid handling device. [0010] Preferably, the shield is connected to the collar by a hanger bar that engages with a hook arm on the collar so that the shield may be pivoted with respect to the collar into several positions. It is within the purview of the present invention to include any structure for connecting the shield to the collar so that the shield may be pivoted with respect to the collar. These structures include known mechanical hinges and various linkages, living hinges, or combinations of hinges and linkages. [0011] Most preferably, the shield is connected to the collar by an interference fit between the hanger bar and the hook bar. Therefore, the shield always is oriented in a stable position and will not move forward or backwards unless movement of the shield relative to the hanger bar and the hook bar is initiated by the user. [0012] Alternatively, the shield and collar may be a unitary one-piece structure. The one-piece structure may be obtained by many methods, including molding the shield and the collar as a one-piece unit, thereby eliminating the separate shield and collar during the manufacturing assembly process. [0013] The assembly of the present invention may further comprise tactile and visual means for deterring the user from contacting the needle, providing easy orientation of the needle with the patient and providing the user with a guide for actuation and engagement with the shield. [0014] The assembly of the present invention may further comprise means for minimizing exposure by the user to residual fluid leaking from a used needle. For example, a polymer material, such as a gel, may be located in the shield. [0015] Most desirably, the assembly of the present invention is such that the cooperating parts of the assembly provide the means for the shield to move into a forward position over the needle. Thus, by simple movement of the shield into a forward position over the used needle, the assembly is ready for subsequent disposal. Therefore, the safety shield assembly of the present invention provides minimal exposure of the user to a needle because the shielding is initiated by the user immediately after the needle is withdrawn from the patient's vein. [0016] Desirably, the assembly of the present invention may be used with a syringe assembly, a hypodermic needle, a needle assembly, a needle assembly with a needle holder, a blood collection set, an intravenous infusion set or other fluid handling devices. Preferably, the assembly of the present invention is used with a needle assembly comprising a needle and a hub. Preferably the needle is a conventional double ended needle. [0017] Most preferably, the present invention is used with a needle assembly comprising a hub and a needle connected to the hub whereby the needle comprises a non-patient end and an intravenous end. The collar of the present invention may comprise a hook arm and the shield may be connected movably to the hook arm. Thus the shield may be pivoted with respect to the collar and moved easily into several positions. [0018] Preferably, the collar is fitted non-rotatably with the hub of the needle assembly. Additionally, the collar includes cooperating means that mate with reciprocal means on the shield to help retain the shield in a final closed position, to propel the shield toward the final closed portion and to provide a clear audible and tactile indication of complete shielding. [0019] The shield preferably includes at least one cannula finger lock for locked engagement with the cannula when the shield is in the final closed position around the needle cannula. The cannula finger lock preferably projects obliquely from one sidewall of the shield angularly toward the opposed sidewall and the top wall of the shield. The cannula finger lock is dimensioned, disposed and aligned to contact the needle cannula when the shield approaches the final closed position. Contact between the cannula and the cannula finger lock will cause the cannula finger lock to resiliently deflect toward the sidewall from which the cannula finger lock extends. Sufficient rotation of the shield will cause the needle cannula to pass the cannula finger lock. As a result, the cannula finger lock will resiliently return to or toward its undeflected condition for securely trapping the needle cannula in the shield. [0020] The shield also preferably includes at least one cannula shelf lock. The cannula shelf lock projects substantially rigidly from a sidewall of the shield. The cannula shelf lock may be a generally triangular panel with a lower edge that is inclined closer to the top wall of the shield at further distances from the sidewall on which the shelf lock is disposed. The shelf lock may further include a top edge that extends substantially parallel to the axis of rotation of the shield and/or substantially parallel to the top wall of the shield. The top edge of the shelf lock may include a recess or groove approximately symmetrically between the sidewalls of the shield for trapping the needle cannula. The cannula shelf lock functions differently from the cannula finger lock. In particular, the cannula finger lock is dimensioned and aligned to deflect in response to engagement with the needle cannula. The cannula shelf lock, on the other hand, is dimensioned and aligned to generate deflection of the needle cannula. Thus, the cannula shelf lock will cause the needle cannula to deflect transversely a sufficient distance for the needle cannula to clear the shelf lock. After sufficient rotation, the needle cannula will clear the shelf lock and resiliently return toward an undeflected condition. Thus, the cannula shelf lock will substantially prevent a re-exposure of the used needle cannula. [0021] Preferably, the collar is fitted with the hub of the needle assembly so that the collar cannot rotate around the hub. Additionally, the collar includes cooperating means that mate with reciprocal means on the shield to propel the shield toward a final closed position. [0022] Alternatively, the collar and hub may be a unitary one-piece structure. The one piece structure may be accomplished by many methods including molding the collar and the hub as a one-piece unit thereby eliminating the need to separately assemble the collar to the hub during the manufacturing process. [0023] Most preferably, the collar is fitted with the hub of the needle assembly so that the bevel surface or bevel up surface of the intravenous or distal end of the needle faces the same side of the collar when the shield is in the open position. Alignment of the collar, hub, shield and needle with the bevel surface up makes it easier to insert the needle into the patient without manipulating the assembly. The orientation of the intravenous end of the needle with the bevel up assures the user that the needle is properly oriented properly for use and does not require any manipulation before use. Most notably, the orientation of the shield provides a visual indication to the user of the orientation of the bevel surface of the needle. [0024] Preferably, the shield is capable of pivoting from an open position where the intravenous end of the needle is exposed and bevel up, to an intermediate position where the needle is partially covered, to a final closed nonretractable position where the needle is covered completely and the shield is locked and no longer able to be moved out of the closed position. [0025] Alternatively, it is within the purview of the present invention that the shield, collar and hub is a unitary one-piece structure. The one-piece structure may be accomplished by many methods including molding the shield, collar and hub as a one-piece unit thereby eliminating the need to separately assemble the shield, collar and hub during the manufacturing process. [0026] It is an advantage of the present invention that the shield covering the used intravenous end of the needle provides easy containment of the used needle. A further advantage of the shield is that it will only move upon initiation by the user. [0027] The assembly of the present invention when used with a fluid handling device is also easily disposable when removed from a conventional needle holder, or other such device. [0028] Another important feature of the present invention includes means for locking the shield in a closed permanent position covering the needle. The closed permanent position will generally withstand the normal forces encountered during proper disposal of the safety shield assembly when it is removed from a conventional needle holder. [0029] A notable attribute of the present invention is that it is easily adaptable with many devices. For example, the invention is usable with syringe assemblies, hypodermic needles, needle holders, blood collection needles, blood collection sets, intravenous infusion sets such as catheters or other fluid handling devices or assemblies that contain piercing elements. [0030] Another notable attribute of the present invention is that the tactile and visual features deter the user from touching the needle, allow the user to easily orient the needle with the patient and guide the user to actuate and engage the shield of the assembly. BRIEF DESCRIPTION OF THE DRAWINGS [0031] FIG. 1 is a perspective view of the safety shield assembly of the present invention as connected to a needle assembly and related packaging features. [0032] FIG. 2 is a perspective view of the unassembled pieces of FIG. 1 . [0033] FIG. 3 is a bottom view of the shield as shown in FIG. 2 . [0034] FIG. 4 is a cross sectional view of the collar as shown in of FIG. 2 taken along lines 4 - 4 thereof. [0035] FIG. 5 is a cross sectional view of the needle hub as shown in FIG. 2 taken along lines 5 - 5 thereof. [0036] FIG. 6 is a cross sectional view of the shield of FIG. 2 taken along lines 6 - 6 thereof. [0037] FIGS. 7-12 illustrate the use of the safety shield assembly with the needle assembly of FIG. 1 with a conventional needle holder. [0038] FIG. 13 is a cross sectional view of the assemblies in use with a conventional needle holder as shown in FIG. 12 taken along lines 13 - 13 thereof. [0039] FIG. 14A is a cross-sectional view of the assemblies of FIG. 13 taken along lines 14 A- 14 A thereof. [0040] FIG. 14B is a cross-sectional view of the assemblies of FIG. 13 taken along lines 14 B- 14 B thereof. [0041] FIG. 15 is a bottom view of the assemblies as shown in FIG. 11 . [0042] FIG. 16 illustrates an additional embodiment of the present invention, whereby a gel material is located in the shield as shown in a bottom view of the assemblies of FIG. 11 . [0043] FIG. 17 is a perspective view of an additional embodiment of the present invention in use with a blood collection set. [0044] FIG. 18 is a perspective view of an additional embodiment of the present invention in use with a syringe. [0045] FIG. 19 is a perspective view of an additional embodiment of the present invention in use with a catheter. DETAILED DESCRIPTION OF THE INVENTION [0046] While this invention is satisfied by embodiments in many different forms, there is shown in the drawings and will herein be described in detail, the preferred embodiments of the invention, with the understanding that the present disclosure is to be considered as exemplary of the principles of the invention and is not intended to limit the invention to the embodiments illustrated. Various other modifications will be apparent to and readily made by those skilled in the art without departing from the scope and spirit of the invention. The scope of the invention will be measured by the appended claims and their equivalents. [0047] Referring to the drawings in which like reference characters refer to like parts throughout the several views thereof, FIGS. 1 and 2 illustrate a needle assembly with the safety shield assembly of the present invention and the related packaging features. The needle assembly includes a needle 40 , a hub 60 , packaging features to cover the needle and a label. The safety shield assembly includes a collar 90 and a shield 140 . [0048] As shown in FIG. 2 and 5 , needle 40 includes a non-patient end 42 , an intravenous end 44 and a passageway 46 extending between the non-patient end and the intravenous end. An elastomeric sleeve 48 covers the non-patient end. A first rigid sleeve 50 covers the intravenous end and a second rigid sleeve 52 covers the non-patient end and the elastomeric sleeve. As shown in FIG. 1 , a label 196 may also be applied to the finally assembled parts. [0049] As shown in FIGS. 2 and 5 , hub 60 includes a threaded end 64 , a ribbed end 66 and passageway 62 extending between the threaded end and the ribbed end. Threaded end 64 and ribbed end 66 are separated by flange 68 . Non-patient end 42 of needle 40 extends from threaded end 64 and intravenous end 44 of needle 40 extends from ribbed end 66 . Preferably, threaded end 64 comprises male threads 80 for mounting the hub on a conventional needle holder and ribbed end 66 comprises male ribs 82 for connecting the hub and collar 90 . [0050] As shown in FIGS. 2 and 4 , collar 90 includes a forward skirt 92 and a rearward skirt 94 . Forward skirt 92 is cylindrical and comprises an inner circumferential surface 96 and an outer circumferential surface 98 . Forward shirt 92 mates with rearward skirt 94 at a shoulder 100 . Rearward skirt 94 is cylindrical and comprises an inner circumferential surface 102 and an outer circumferential surface 104 and extends from shoulder 100 opposite of forward skirt 92 . The inner diameter of forward skirt 92 is larger than the inner diameter of rearward skirt 94 . Alternatively, the inner diameters for collar 90 can be equal. A hook 114 extends from outer circumferential surface 98 of forward skirt 92 . Additionally, detents or protrusions 118 project outwardly from outer circumferential surface 98 of forward skirt 92 at a side opposite hook 114 . Protrusions 118 may define a substantially chevron-shape with well defined edges 119 facing toward rearward skirt 94 . [0051] As shown in FIGS. 2 and 6 , shield 140 comprises a rearward end 144 and a forward end 146 . [0052] Forward end 146 of shield 140 includes a slot or longitudinal opening 160 formed by sidewalls 162 that extend downwardly from top wall 163 and run substantially opposite of one another in parallel along the length of slot 160 towards forward end wall 164 . Slot 160 is slightly wider than needle 40 . Sidewalls 162 include bottom edges 165 that extend substantially parallel to one another and parallel to top wall 163 . [0053] A cannula finger lock 167 is located at one of sidewalls 162 and is configured to secure the used needle. Cannula finger lock 167 extends from a location on a first of the sidewalls 162 adjacent the bottom edge 165 thereof and projects angularly toward the opposed sidewall 162 and toward the top wall 163 . The projection of the cannula finger lock 167 from the respective sidewall 162 preferably exceeds half the distance between the respective sidewalls. Cannula first lock 167 is deflectable by the needle when the needle enters slot 160 . Once the needle passes the end of cannula finger lock 167 , the cannula finger lock moves back to its original position so that the needle is permanently trapped in slot 160 by cannula finger lock 167 . [0054] Rearward end 144 of shield 140 defines a collar engaging area 166 that is a continuation of slot 160 . Collar engaging area 166 includes a rearward end 168 , a forward end 170 , a top finger guide area 172 , sidewalls 174 that extend downwardly from top finger guide area 172 , an underside area 176 dimensioned for surrounding collar 90 , and extending arms 180 to support hold hanger bar 182 . Sidewalls 174 are spaced apart by a major width adjacent rearward end 168 . The major width is selected to enable sidewalls 174 to slide across diametrically opposite side surfaces of forward skirt 92 of collar 90 . Sidewalls 174 converge, however, toward forward end 170 to define a minor distance therebetween substantially equal to the distance between sidewalls 162 at forward end 146 of shield 140 . Sidewalls 174 include bottom edges 177 that face away from top finger guide area 172 . As shown most clearly in FIG. 6 , bottom edges 177 curve toward top finger guide area 172 at locations between rearward end 168 and forward end 170 of collar engaging area 166 . [0055] Shield 140 further includes a cannula shelf lock 220 . Cannula shelf lock 220 is a substantially planar and substantially rigid panel that projects orthogonally from one side wall 174 at a location at or near the interface of forward sidewalls 162 and rearward sidewalls 174 . Cannula shelf lock 220 includes a bottom edge extending substantially from bottom edge 177 of sidewall 174 angularly toward top wall 163 and/or top finger guide area 172 . Cannula shelf lock 220 further includes a top edge 224 aligned substantially parallel to the axis about which shield 140 rotates. Top edge 224 includes a cylindrically generated concavity 226 generated about an axis extending parallel to top wall 163 and dimensioned to accommodate needle 44 . Slanted bottom edge 222 and top edge 224 meet at a corner 228 that is spaced from the opposed sidewall of shield 140 by a distance that exceeds the outside diameter of needle 44 . [0056] The extreme rear ends of sidewalls 174 on collar engaging area 166 include rounded ears 194 that project toward one another from opposed inner surfaces 175 of sidewalls 174 . Rounded ears 194 are disposed to engage detents 118 on collar 90 . More particularly, each rounded ear 194 includes a distal surface 195 , a proximal surface 197 and a curved surface 198 extending between distal and proximal surfaces 195 and 197 . Distal surface 194 is aligned to sidewall 174 at a rake angle of approximately 60° and proximal surface 197 is aligned to sidewall 174 at an angle of approximately 45°. Curved surface 198 extends smoothly and convexly between distal and proximal surfaces 195 and 197 . Proximal surfaces 197 of rounded ears 194 will engage detents 118 to deflect sidewalls 174 slightly away from one another as shield 140 approaches the second position. This deflection of sidewalls 174 will occur substantially simultaneously with the deflection of cannula finger lock 167 and with the deflection of needle 44 in response to engagement with cannula shelf lock 220 . The apex of curved surface 198 on each rounded ear 194 passes the respective detent 118 on collar 90 slightly before cannula finger lock 167 and cannula shelf lock 220 pass the needle cannula. As a result, sidewalls 174 begin to return resiliently toward an undeflected condition. This resilient return of sidewalls 174 cooperates with raked distal surfaces 195 on rounded ears 194 to propel shield 140 into the second position where cannula finger lock 167 and cannula shelf lock 220 pass needle 44 . This acceleration of shield 140 caused by the resilient return of sidewalls 174 and raked distal surface 195 of ears 194 also causes sidewalls 174 to snap against detents 118 . This snapping action provides a clear audible and tactile indication of complete shielding and occurs substantially when the used needle is trapped by cannula finger lock 167 and cannula shelf lock 220 . The angles of distal and proximal surfaces 195 and 197 of rounded ears 194 affects the performance of shield 140 . In particular, a smaller acute angle alignment of proximal face 197 reduces the force required to move shield 140 passed rounded ears 194 . A larger acute angle proximal surface 197 of rounded ears 194 requires a greater force to move shield 140 toward the second position. Similarly, the angle between distal surface 195 and sidewall 174 affects the acceleration characteristics as shield 140 is propelled toward the second position in response to the resilient return of sidewalls 174 . [0057] Top finger guide area 172 comprises a first ramp 184 that extends slightly on an upwardly slope from the rearward end of the collar engaging area to a shoulder 186 . From shoulder 186 extends a second ramp 188 which slopes downwardly towards top section 163 . Most preferably, first ramp 184 comprises touch bumps 190 . The touch bumps provide a tactile and visual guide to alert the user that the user's finger has contacted the shield and that the shield is in a defined or controlled position. The touch bumps may be any configuration so long as they extend and are distinct from the top finger guide area. The touch bumps may also be of a distinguishing color as compared to the top finger guide area or the shield. [0058] Second ramp 188 has interior surface 192 for urging the needle toward the center of slot 160 as the shield is being rotated into the closed position. The exterior surfaces are slightly inclined and extending radially from the second ramp. The interior surfaces are especially helpful if the longitudinal axis of the needle is misaligned with respect to the longitudinal axis of the hub. [0059] Extending arms 180 are located at rearward end 168 and at the beginning of top finger area 172 and hold hanger bar 182 . [0060] The safety shield assembly and the needle assembly are assembled together whereby needle 40 is connected to hub 60 and sealed with adhesive at the ends of the hub. Hub 60 is then joined with collar 90 by ultra-sonic welding techniques or any other bonding techniques, or mechanical fit, whereby rearward annular skirt 94 of collar 90 mates with ribbed end 66 of the hub. Male ribs 82 of the hub are contained or forced fitted within inner sidewall 102 of rearward annular skirt 94 of collar 90 . The collar is aligned with the intravenous end of the needle whereby the hook arm is aligned with the bevel up of the needle. Then rigid sleeve 50 is force fitted into inner side wall 96 of forward skirt 92 of collar 90 to cover the needle. Thereafter, shield 140 is connected to collar 90 whereby hanger bar 182 is force fitted into hook member 114 whereby slot 160 faces rigid sleeve 50 . Most preferably, the shield is connected to the collar by a force fit or interface fit between the hanger bar and the hook bar. Therefore, the shield is always oriented in a stable position and will not move unless movement of the shield is positively initiated by the user. To assemble the last piece, shield 140 is moved towards rigid sleeve 50 and second rigid sleeve 52 is force fitted onto outer sidewall 104 of rearward skirt 94 of collar 90 . [0061] In addition, a label 196 may be applied to the finally assembled parts. The label may be used to prevent tamper resistance of the parts, so that they are not reused. [0062] In use, as shown in FIGS. 7-15 , the non-patient needle shield is removed and then a needle holder is screwed onto the hub of the needle. As specifically shown in FIGS. 8 and 12 the shield is then rotated back by the user towards the needle holder. Then as shown in FIG. 9 , the intravenous needle shield is removed from covering the intravenous needle. Then as shown in FIG. 10 , a venipuncture is conducted whereby the intravenous end of the needle is inserted into a vein of a patient and an evacuated tube having a closure is inserted into the needle holder. Then as shown in FIGS. 11 and 13 , when the venipuncture is complete the user easily rotates the shield from the open position towards the intravenous needle to an intermediate position and then the user pushes on the shield at the top finger guide area to move the shield into a final, non-retractable locked position whereby the needle is trapped in the longitudinal opening. More particularly, needle 44 contacts cannula finger lock 167 and cannula shelf lock 220 . The engagement of needle 44 with cannula finger lock 167 causes cannula finger lock 167 to deflect toward top wall and toward the sidewall 162 from which cannula finger lock 167 projects. Simultaneously, sloped bottom edge 222 of cannula shelf lock 220 will cause needle 44 to deflect. Sufficient rotation of shield 140 will cause needle 44 to pass both cannula finger lock 167 and cannula shelf lock 220 . As a result, cannula finger lock 167 will return resiliently to an undeflected condition and needle 44 will return resiliently to an undeflected condition. Thus, needle 44 will be trapped above cannula finger lock 167 and above cannula shelf lock 220 . Additionally, needle 44 will be retained securely in concave region 226 of cannula shelf lock 220 . The combination of cannula finger lock 167 and cannula shelf lock 220 can provide more secure protection than a single cannula finger lock or a plurality of finger locks. More particularly, a cannula finger lock provides a secure trapping of needle 44 , albeit with relatively low resistance to a forced attempt to intentionally re-expose needle 44 . On the other hand, shelf lock 220 provides somewhat less effective trapping than cannula finger lock 167 in that a transverse shifting for the shield could bypass a cannula shelf lock that was used alone. However, a cannula shelf lock provides much more secure resistance to a forcible attempt to rotate shield 140 back to its initial position. Thus, the cannula finger lock 167 and cannula shelf lock 220 cooperate to provide significantly enhanced trapping and resistance to re-exposure of cannula 44 . [0063] Needle 44 is contained within shield 140 as the shield is pivoted into the closed position. More particularly, proximal surfaces 197 of rounded ears 194 move over detents 118 and cause sidewalls 174 to deflect away from one another. The angularly aligned proximal faces 197 of rounded ears 194 ensures easy movement of shield 140 . Additionally, the resiliency of sidewalls 174 and the angular alignment of distal surface 195 of ears 194 causes shield 140 to be accelerated into the full shielding closed position. Thus needle 44 snaps past cannula finger lock 167 and cannula shelf lock 220 and is trapped as shown in FIGS. 14A, 14B and 15 to ensure complete locking of shield 140 in the closed position. This accelerated movement of shield 140 helps to generate a clear audible and tactile indication of complete shielding. [0064] Alternatively as shown in FIG. 16 , a gel material 190 is located in shield 140 so that when the needle snaps past cannula finger lock 167 and cannula shelf lock 220 it will come to rest in gel material 190 . The gel material will contain any residual fluid that may be on the needle. Simultaneously, rounded ears or projections 198 move over detents 118 . This causes sidewalls 174 to deflect away from one another and then to snap back into engagement with collar 90 to provide a clear audible and tactile indication of complete shielding. [0065] FIGS. 17, 18 , and 19 are further embodiments of the invention that include may components which are substantially identical to the components. FIGS. 1-3 . Accordingly, similar components performing similar functions will be numbered identically to those components of FIGS. 1-3 , except that a suffix “a” will be used to identify those similar components in FIG. 17 , a suffix “b” will be used to identify those similar components in FIG. 18 and a suffix “c” will be used to identify those similar components in FIG. 19 . [0066] Alternatively, the safety shield assembly of the present invention may be used in conjunction with a conventional intravenous (IV) fusion set, as illustrated in FIG. 17 . [0067] For purposes of illustration, shield 140 a and collar 90 a are connected to a conventional IV infusion set, 200 , or butterfly structure comprising a needle body with a needle hub 204 extending from the forward end of the needle body and a needle 206 embedded in hub 204 . Extending from the rearward end of the needle body is flexible tubing 208 which is conventional and utilized to allow the user to manipulate the structure and to connect it subsequently to supplies of infusion liquids or for the return of collected blood if the arrangement is being used to collect blood. [0068] Infusion set 200 further comprises flexible wings 210 attached to and projecting outwardly from needle hub 204 . [0069] Alternatively, the safety shield assembly of the present invention may be used in conjunction with a syringe, as illustrated in FIG. 18 . [0070] For purposes of illustration, shield 140 b and collar 90 b are connected to a conventional hypodermic syringe 300 comprising a syringe barrel 302 having a distal end 304 a proximal end 306 and a plunger 312 . [0071] Alternatively, the present invention may be used in conjunction with a catheter as illustrated in FIG. 19 . [0072] The shield and collar of the safety shield assembly of the present invention are comprised of moldable parts which can be mass produced from a variety of materials including, for example, polyethylene, polyvinyl chloride, polystyrene or polyethylene and the like. Materials will be selected which will provide the proper covering and support for the structure of the invention in its use, but which will provide also a degree of resiliency for the purpose of providing the cooperative movement relative to the shield and the collar of the assembly.

1a

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] The present invention concerns a method to show a concentration of a contrast agent or the course of the concentration of the contrast agent in a predetermined volume segment by means of a tomosynthesis, as well as a correspondingly designed tomosynthesis apparatus. [0003] 2. Description of the Prior Art [0004] To differentiate malignant and benign lesions or tumors, it is known to administer a contrast agent TO the volume segment to be examined and to produce a corresponding evaluation of the lesion or the tumor using the dynamic of the contrast agent concentration. Particularly in the case of malignant tumors, an enrichment of the contrast agent in the tumor (which normally takes place very quickly (within approximately 1 min)) occurs due to the neovascularization. A fast imaging is required in order to measure this increase in the contrast agent concentration. A tomosynthesis scan typically lasts up to 25 s, and when the contrast agent concentration within the volume segment to be shown changes very significantly in the enrichment phase during this time this leads to problems in the reconstruction since inconsistent data from the different angles (due to the temporally varying contrast agent concentration) are acquired during the tomosynthesis scan. SUMMARY OF THE INVENTION [0005] An object of the present is to better show or measure the contrast agent concentration and/or the course of the contrast agent concentration than is possible according to the prior art. [0006] The object is achieved in accordance with the scope of the present invention by a method to show a concentration of a contrast agent in a predetermined volume segment of an examination subject by means of a tomosynthesis apparatus. After a (most often intravenous) administration of the contrast agent, the method includes the following steps: Create a two-dimensional, low-energy image (mammography) of the predetermined volume segment with a low x-ray energy or, low x-ray dose (in a range from 20 to 35 kVp, for example). The low energy image is in particular thereby created in a standard screening projection (CC or MLO) or, more rarely, as a diagnostic exposure (spot compression, magnification mammography). Given the CC alignment (“cranial-caudal”, from head to foot), the x-rays are generated such that the x-ray tube (for example) is aligned such that the x-rays travel vertically. In contrast to this, given the MLO alignment (“medio-lateral oblique”) the x-rays run with a defined angle relative to the vertical alignment. Generate one or more two-dimensional high-energy images (mammography) of the predetermined volume segment with a high x-ray energy (in a range from 40 to 50 kVp) that is significantly higher than the low x-ray energy of the low-energy image. The high-energy image or images is/are generated after the low-energy image, with the alignment to generate the high-energy image or images being the same as the alignment in the generation of the low-energy image. Implement a high-energy tomosynthesis of the predetermined volume segment. Automatically subtract the two-dimensional low-energy image from the at least one two-dimensional high-energy image. If it is only one high-energy image, the low-energy image is subtracted with weighting from this high-energy image. Given multiple high-energy images, the low-energy image is subtracted with weighting from each of these high-energy images. A resulting image in which the concentration of the contrast agent is visible is generated by this subtraction. This subtraction is also designated as a non-temporal dual-energy subtraction (or “dual-energy subtraction”). Image data of an earlier low-energy tomosynthesis which was implemented before the administration of the contrast agent are subtracted from image data of the high-energy tomosynthesis, which is also known as a temporal dual-energy subtraction. [0012] While the spectrum (more precisely the focal point of the spectrum) of the x-rays for generation of the high-energy images is markedly above the k-edge of the contrast agent, the spectrum (more precisely the focal point of the spectrum) of the x-rays to generate the low-energy image is markedly below this k-edge. Given the use of an iodine contrast agent, a tube voltage of well above 33 kVp (the iodine absorption edge and k-edge are at 33 kV) is used to generate a high-energy image and a tube voltage of well below 33 kVp is used to generate a low-energy image. (Given the use of gadolinium as a contrast agent, a markedly harder radiation would in particular have to be used to generate the high-energy image in comparison to iodine, for example.) The x-ray photons in the generation of the high-energy image have a sufficient amount of energy in order to strip an electron of a contrast agent atom from the k-shell, such that the contrast agent absorbs at least a portion of the x-ray radiation. In contrast to this, given the generation of the low-energy image the x-ray photons (for the most part) have insufficient energy to strip an electron of a contrast agent atom from the k-shell, such that the x-ray radiation is not absorbed by the contrast agent. [0013] The individual projections of the high-energy tomosynthesis are similarly generated with an x-ray radiation whose spectrum lies well above the k-edge of the contrast agent, while the individual projections of the low-energy tomosynthesis are generated with an x-ray radiation whose spectrum is well below this k-edge. Since the x-ray energy or, respectively, dose is normally determined from the product of the high voltage (with which the x-ray tube operates), the tube current and the acquisition duration (switching time), the tube voltage (and therefore the energy of the individual x-ray photons) to acquire a single image and to acquire a projection of a tomosynthesis can be the same, but nevertheless the x-ray dose to generate the projection can be markedly lower than the x-ray dose to generate the single image. [0014] There are multiple possibilities in order to subtract the image data of the low-energy tomosynthesis scan from the image data of the high-energy tomosynthesis scan: The projections of the low-energy tomosynthesis scan are registered (possibly with the use of an angle interpolation) with the corresponding projections of the high-energy tomosynthesis scan, and then a subtraction of the respective projection of the low-energy tomosynthesis scan from the respective projection of the high-energy tomosynthesis scan is implemented, wherein a reconstruction of slice images can thereby be produced. A defined slice within the predetermined volume segment is reconstructed from the low-energy tomosynthesis scan while a three-dimensional model of the predetermined volume segment is created from high-energy tomosynthesis scan, which model also contains information per voxel about the contrast agent content per point in time. Slice images of the defined slice are reconstructed from this three-dimensional model at respective different points in time, which slice images then respectively contain information about the contrast agent content corresponding to the point in time. Stated in a different way, a reconstruction is implemented first and then a subtraction of the (in particular registered and motion-corrected) slices. [0017] The method according to the invention accordingly combines the temporal dual-energy subtraction of tomosynthesis results with the non-temporal dual-energy subtraction of two-dimensional images. As used herein, a dual-energy subtraction is a subtraction of first and second image data, with the first image data being generated with a higher x-ray energy than the second image data. For this reason the method is also called a two-spectra method since the x-ray radiation to generate the low-energy image data and the x-ray radiation to generate the high-energy image data have different wavelengths. Stated differently, the dual-energy subtraction designates the subtraction of a low-energy image from only one high-energy image, both of which are acquired in a short time interval. [0018] While the first and second image data are generated within a quite short time period (1-50 s) in the non-temporal dual-energy subtraction, the first and second image data are created at different points in time in the temporal dual-energy subtraction, which points in time can by all means be separated by multiple minutes. In the temporal dual-energy subtraction, multiple subtractions are implemented by means of high-energy slice image generated (or reconstructed) at time intervals, so a series of subtraction images is created with which the course of the contrast agent can be shown. [0019] Stated differently, the present invention combines the contrast agent-assisted dual-energy tomosynthesis (CEDET, “Contrast-Enhanced Dual-Energy Tomosynthesis”) with contrast agent-assisted mammography (CEDM, “Contrast-Enhanced Digital Mammography”). [0020] According to the invention, differentiation is made between the generation of two-dimensional images (mammography) and generation of the tomosynthesis image. Digital tomosynthesis is a combination of a digital image acquisition and image processing given a small movement of the x-ray tube or x-ray source. Tomosynthesis has certain similarities to computed tomography (CT) but is considered a separate technique by those in the art. In computed tomography, images are generated during a complete 360° revolution of the x-ray source around the examination subject, but in tomosynthesis the x-ray source pans only around the subject through a small angle (of 40°, for example), so only a small number of exposures (typically between 7 and 60) is created. By the use of high-resolution detectors, a very high resolution can be achieved in planes perpendicular to the Z-axis (axis in the direction of the tomosynthesis angle 0°, or the vertical direction, or the CC alignment), even though the resolution is lower in the direction of the Z-axis. The primary field of use of tomosynthesis is imaging of the female breast as a supplement to or replacement for mammography. In comparison to mammography, tomosynthesis operates with a lower radiation energy per projection. For example, given the same energy of individual x-ray photons, the total radiation energy (i.e. the sum of the radiation energies required to create all projections) of the tomosynthesis corresponds to one to two times the radiation energy to generate a two-dimensional image. [0021] Corresponding information from earlier two-dimensional exposures and/or of earlier tomosynthesis scans is used in order to determine the x-ray energy to generate the two-dimensional low-energy image, the at least one two-dimensional high-energy image, and for the high-energy tomosynthesis scan. [0022] For example, the two-dimensional low-energy image and the high-energy image or, respectively, images can be generated in the enrichment phase of the contrast agent in order to detect the rising edge of the contrast agent concentration. The high-energy tomosynthesis scan then represents the wash-out phase (falling edge of the contrast agent concentration). Since the enrichment phase is normally shorter than the wash-out phase, the two-dimensional images (the low-energy image and the at least one high-energy image) are used to detect the concentration of the contrast agent, or better to track the contrast agent concentration, since a few two-dimensional images can be generated in a shorter period of time than is necessary to implement a tomosynthesis scan. [0023] For example, a time interval can be provided in which an enrichment of the contrast agent presumably occurs within the predetermined volume segment. The two-dimensional low-energy image and the at least one two-dimensional high-energy image are then automatically created in this time interval. [0024] According to the invention, it is ensured that the two-dimensional low-energy image and the at least one two-dimensional high-energy image are generated in an enrichment phase of the contrast agent so that the non-temporal dual-energy subtraction allows conclusions about the contrast agent course in this enrichment phase. [0025] A registration of the two-dimensional low-energy image and the at least one two-dimensional high-energy image advantageously occurs before the subtraction of the two-dimensional low-energy image of the at least one two-dimensional high-energy image, wherein an earlier two-dimensional low-energy image of the predetermined volume segment which was generated before the administration of the contrast agent is used for registration. This earlier two-dimensional low-energy image is normally an image which was created in an earlier examination of the patient. [0026] By means of the registration, the images to be subtracted are advantageously adapted to one another and possible movements of the subject are corrected. The goal in the image registration is to find a transformation that brings the high-energy image into congruence with the low-energy image in the best possible manner. This prevents image regions that do not match one another from being subtracted from one another in the subtraction. [0027] Via the use of an earlier two-dimensional low-energy image in the registration, movement artifacts, position-dependent subject changes and compression-dependent subject changes are advantageously compensated in the creation of the currently generated two-dimensional images. [0028] According to the invention, it is possible for the two-dimensional low-energy image and/or the at least one high-energy image are created within the scope of the implementation of the high-energy tomosynthesis scan. For this, corresponding acquisition parameter settings (filter settings, tube voltage, tube current, acquisition duration) of the tomosynthesis apparatus and corresponding power supply parameters for an x-ray source of the tomosynthesis apparatus are produced given a change from tomosynthesis acquisition to acquisition of the two-dimensional low-energy image and/or of the at least one high-energy image. To continue the tomosynthesis scan, these altered filter settings and altered power supply parameters must again be changed to their settings for the tomosynthesis. [0029] The generation of the two-dimensional images during the tomosynthesis advantageously enables the two-dimensional images to be created at an arbitrary point in time (thus not immediately before the tomosynthesis). [0030] According to one embodiment according to the invention, the following Steps can be implemented in the following order: 1: Generate the two-dimensional low-energy image of the predetermined volume segment of an examination subject. 2. Generate the at least one high-energy image of the predetermined volume segment. 3. Generate an additional two-dimensional low-energy image of an additional volume segment of the examination subject. 4. Generate at least one additional high-energy image of the additional volume segment. 5. Implement an additional high-energy tomosynthesis scan of the additional volume segment. 6. Implement the high-energy tomosynthesis scan of the predetermined volume segment. [0037] The additional two-dimensional low-energy image is subtracted from the additional high-energy images or from the multiple additional high-energy images in order to make the concentration of the contrast agent visible in the additional volume segment using the results or result images thereby generated via this additional non-temporal dual-energy subtraction. Image data of an earlier low-energy tomosynthesis scan of the additional volume segment can be subtracted from image data of the high-energy tomosynthesis scan of the additional volume segment within the scope of a temporal dual-energy subtraction in order to obtain corresponding results about the contrast agent course in the additional volume segment. [0038] This embodiment according to the invention enables the examination of two different examination subjects (for example of a right breast and a left breast of a patient) with only a single administration of the contrast agent. [0039] The temporal dual-energy subtraction—in which image data of the earlier low-energy tomosynthesis scan are subtracted from image data of the high-energy tomosynthesis scan—in particular requires a registration in which the image data of the earlier low-energy tomosynthesis scan are registered with the image data of the high-energy tomosynthesis scan, depending on the two-dimensional low-energy image. [0040] By the use of the two-dimensional low-energy image in the registration, movement artifacts, positioning-dependent subject changes and compression-dependent subject changes can advantageously be compensated in the generation of the high-energy tomosynthesis scan. [0041] Moreover, it is possible for a time interval to be provided in which a washing-out of the contrast agent is expected within the predetermined volume segment. The high-energy tomosynthesis is subsequently implemented automatically in this time interval in that parameters of the high-energy tomosynthesis (for example the number of projections to be generated or the time interval between the projections) is adapted such that the high-energy tomosynthesis can be implemented in the provided time interval. [0042] According to an additional embodiment according to the invention, the following Steps can be implemented in the following order after the administration of the contrast agent: 1. Generate the two-dimensional low-energy image of the predetermined volume segment. 2. Generate an additional two-dimensional low-energy image of an additional volume segment. 3. Implement an additional high-energy tomosynthesis scan of the additional volume segment, wherein one or more additional two-dimensional high-energy images of the additional volume segment are thereby also generated. 4. Implement the high-energy tomosynthesis scan of the predetermined volume segment, wherein the one or more high-energy images of the predetermined volume segment are also generated. [0047] The additional two-dimensional low-energy image is thereby also subtracted from the high-energy image or the respective additional high-energy images (non-temporal dual-energy subtraction). A temporal dual-energy subtraction of image data of an earlier low-energy tomosynthesis scan (which was implemented before the administration of the contrast agent with regard to the additional volume segment) from image data of the additional high-energy tomosynthesis scan of the additional volume segment can also be implemented. [0048] The method according to the invention offers the following advantages: A combination of a dual-energy imaging (difference from the two-dimensional low-energy image and the two-dimensional high-energy images) with a depiction of the chronological enrichment of the contrast agent and the wash-out phase (in particular via results of the high-energy tomosynthesis) is possible. The contrast agent course can be determined very precisely via the generation of two-dimensional images in the temporally short enrichment phase. A localization, for example of lesions and tumors, is also possible in three-dimensional space via the use of the high-energy tomosynthesis during the temporally longer (comparable to the enrichment phase) wash-out phase. [0052] Within the scope of the present invention, an additional method is also provided to show a concentration of a contrast agent in a predetermined volume segment of an examination subject by means of a tomosynthesis apparatus. This additional method comprises the following Steps: Provide a time interval in which an enrichment or a washing-out of the contrast agent within the predetermined volume segment is expected. Automatically implement a tomosynthesis scan of the predetermined volume segment in the provided time interval. The concentration of the contrast agent in the predetermined volume segment is depicted or determined depending on the results of this tomosynthesis scan. [0055] Because the tomosynthesis scan is adapted to the provided time interval or is synchronized with the provided time interval, both the contrast agent course in the enrichment phase and the contrast agent course in the wash-out phase are optimally shown and measured by means of the tomosynthesis scan. Due to the high coefficient of attenuation of the contrast agent, an image contrast of a possibly present malignant tumor is sufficient, even given the low radiation energy (in comparison to mammography or the generation of two-dimensional images) that is used to generate the projections during the tomosynthesis, to quantitatively determine the contrast agent concentration in the tumor (i.e. via corresponding pixel values). Since the projections generated during the tomosynthesis are acquired in succession, the contrast agent course can be shown and measured via the tomosynthesis scan. [0056] For example, a number of exposures to be generated can be provided during a tomosynthesis scan. The time interval between two successive acquisitions of these exposures to be generated can be adapted to the provided time interval such that the provided number of exposures to be generated is generated within the predetermined time interval. [0057] It is thereby ensured that the provided number of exposures to be generated is generated entirely during the enrichment phase or during the wash-out phase. Stated in a different way, the tomosynthesis scan can thereby advantageously be synchronized with the administration of the contrast agent so that the tomosynthesis scan takes place directly in the time interval of interest (i.e. across the entire enrichment phase or across the entire wash-out phase). In other words, the scan speed is adapted to the dynamic of the contrast agent, i.e. to the course of the contrast agent. According to the invention it is correspondingly taken into account that the enrichment of the contrast agent takes place relatively quickly (within approximately 10-50 s) so that a fast tomosynthesis scan (short interval between successive acquisitions) must be conducted. In contrast to this, the duration of the time curve of interest in the elimination of the contrast agent (wash-out phase) amounts to a few minutes. This means that the duration of the tomosynthesis scan is set so that this duration corresponds to the duration of the enrichment phase or, respectively, wash-out phase. [0058] According to the invention, it is possible for both the enrichment phase and the wash-out phase to be tracked with a respective tomosynthesis scan. For this, a first time interval in which the enrichment of the contrast agent is expected within the predetermined volume segment and a second time interval in which the washing-out of the contrast agent is expected within the predetermined volume segment are provided. A first tomosynthesis scan is then implemented in the first time interval and a second tomosynthesis scan is implemented in the second time interval in order to show or to determine the concentration of the contrast agent in the predetermined volume segment, depending on the results of these two tomosynthesis scans. This means that the duration of the first tomosynthesis scan is set such that it corresponds to the first time interval and the duration of the second tomosynthesis scan is set such that it corresponds to the second time interval. [0059] Starting from results of the tomosynthesis scan or scans, slice images of the predetermined volume segment can be reconstructed under consideration of a kinetic model of a flow of the contrast agent within the predetermined volume segment. The kinetic model is based on an equation system with differential terms to determine the propagation of the contrast agent in the enrichment phase and/or the wash-out phase. The kinetic model is known from CE-MRI (“Contrast Enhanced Magnet Resonance Imaging”); see “Imaging Systems for Medical Diagnostics”; A. Oppelt ISBN: 3-89578-226-2, Pages 660-667 and “Automatic identification and classification of characteristic kinetic curves of breast lesions on DCE-MRI; W. Chen et al.; Medical Physics, Vol. 33, No. 8, August 2006; Pages 2878-2887. The kinetic model is known from pharmacokinetics and describes the concentration of the contrast agent as a function of time with conventional differential equations with parameters which describe the acquisition or, respectively, delivery of the contrast agent (pharmaceutical) in a compartment (vessel, cell, intracellular space). Pharmacokinetics, as a scientific sub-field of pharmacology, primarily researches and describes the effect of the body on an applied pharmaceutical or, respectively, (stated in a different way) its time curve in individual regions of the body. [0060] By using the kinetic model in the reconstruction, variations due to different contrast agent concentrations at different points in time in the same volume segment can be taken into account in the reconstruction of three-dimensional image information of the predetermined volume segment from the projections created during the tomosynthesis. [0061] Moreover, it is possible to reconstruct image data with an iterative reconstruction algorithm, starting from results of the tomosynthesis scan or scans. The iterative reconstruction algorithm can thereby contain a model of the contrast agent flow as a boundary condition of the projection images to be created. In other words, in the generation of the three-dimensional image information the iterative reconstruction algorithm accounts for the fact that different contrast agent concentrations (as a result of the contrast agent flow) prevail in the same volume segment at different points in time. For example, ART (“Algebraic Reconstruction Technique”), SART (“Simultaneous ART”), SIRT (“Simultaneous Iterative Reconstruction Technique”), ML (“Maximum Likelihood”) or MAP (“Maximum Activity Projection”) can be used as an iterative reconstruction algorithm. [0062] In the event that only a few tomosynthesis scans are implemented (for example only two, namely a scan during the enrichment and a scan during the depletion), the total dose or total energy of the x-rays during the tomosynthesis scan according to the invention can be set to be higher by a predetermined factor (2, for example) than is normally the case in the implementation of a normal tomosynthesis. [0063] By the increase of the total dose of the x-rays corresponding to the predetermined factor, the quality of the generated image data—and therefore the reliability of the quantitative image evaluation—can be increased. [0064] Moreover, the contrast agent concentration in the predetermined volume segment can be determined from difference images. For this an image of the predetermined volume segment which was created by means of a tomosynthesis apparatus before an administration of the contrast agent is subtracted from an additional image which is reconstructed starting from results of the tomosynthesis implemented according to the invention in order to determine the concentration of the contrast agent in the predetermined volume segment via the corresponding difference image. [0065] The further method according to the invention offers the following advantages: in comparison to magnetic resonance tomography, a higher spatial resolution and a higher temporal resolution can be realized specifically in the fast enrichment phase. In that the scan speed (i.e. the duration in which the tomosynthesis scan is implemented) is adapted to the contrast agent dynamic, the total radiation dose with which the patient is exposed can be kept optimally low. [0068] It is noted that the method according to the invention and the further method according to the invention can be combined with one another. In particular, the further method according to the invention can be used to implement the high-energy tomosynthesis scan in the wash-out phase. [0069] The present invention also encompasses a tomosynthesis apparatus with a detector and an x-ray source (in order to limit x-rays directed towards the detector) is also provided. An examination subject (in particular a female breast) can thereby be positioned between the x-ray source and the detector such that the x-rays traverse a predetermined volume segment of the examination subject before they strike the detector. The tomosynthesis apparatus has a controller to activate the x-ray source and the detector and an image computer in order to receive data of the predetermined volume segment (said data acquired by the detector) and to generate an image which shows a concentration of a contrast agent in the predetermined volume segment. After administration of a contrast agent, the tomosynthesis apparatus generates a two-dimensional low-energy image of the predetermined volume segment and at least one two-dimensional high-energy image of the predetermined volume segment, wherein a radiation energy to create a high-energy image is significantly higher than the radiation energy to create the low-energy image. Moreover, after the administration of the contrast agent the tomosynthesis apparatus implements a high-energy tomosynthesis of the predetermined volume segment, wherein a total radiation dose of the high-energy tomosynthesis is significantly higher than a radiation dose to create the two-dimensional low-energy image. With the aid of the image computer, the controller subtracts the two-dimensional low-energy image from each high-energy image (non-temporal dual-energy subtraction) in order to generate a result or, respectively, result image in which the concentration of the contrast agent can be shown. [0070] The advantages of the tomosynthesis apparatus according to the invention substantially correspond to the advantages of the corresponding method according to the invention as described above. [0071] Within the scope of the present invention, an additional tomosynthesis apparatus with a detector and an x-ray source for the emission of x-rays directed toward the detector is also provided. In this additional tomosynthesis apparatus an examination subject (in particular a female breast) can be positioned between the x-ray source and the detector such that the x-rays traverse a predetermined volume segment of said examination subject before they strike the detector. The additional tomosynthesis apparatus also has a controller to activate the x-ray source and the detector, as well as an image computer in order to receive data of the predetermined volume segment (said data acquired by the detector) and generate an image from which a concentration of a contrast agent in the predetermined volume segment can be derived. A time interval in which an enrichment or a washing-out of the contrast agent within the predetermined volume segment is expected can be provided to the controller. Within the provided time interval, the tomosynthesis apparatus implements a tomosynthesis in order to determine the concentration of the contrast agent in the predetermined volume segment depending on results of this tomosynthesis (the result is in particular an image). [0072] The advantages of the additional tomosynthesis apparatus according to the invention significantly correspond to the advantages of the additional method according to the invention which are stated in detail in the preceding, such that a repetition is omitted here. [0073] Furthermore, the present invention encompasses a non-transitory computer-readable storage medium encoded with programming instructions or control commands (software), which can be loaded into a memory of a programmable controller or a computer of a tomosynthesis apparatus. All or various embodiments of the methods according to the invention that are described in the preceding can be executed by when the computer program in the controller or control device of the tomosynthesis apparatus according to the encoded information. The programming instruction may require other items (libraries and auxiliary functions, for example) in order to realize the corresponding embodiments of the methods. The software can be source code (C++, for example) that must still be compiled (translated) and linked or that only needs to be interpreted, or can be an executable software code that has only to be loaded into the corresponding computer for execution. [0074] The electronically readable data medium can be, for example, a DVD, a magnetic tape or a USB stick,—on which is stored electronically readable control information, in particular software (see above). [0075] The present invention is particularly suitable to supplement or extend contrast agent-assisted mammography. Naturally, the present invention is not limited to this preferred field of application since contrast agent courses or contrast agent concentrations in other regions of the body of a living organism can also be shown with the present invention. BRIEF DESCRIPTION OF THE DRAWINGS [0076] FIG. 1 schematically depicts a tomosynthesis apparatus according to the invention. [0077] FIG. 2 shows a workflow according to the invention of a dual-energy image acquisition, image processing and presentation, beginning with the contrast agent administration. [0078] FIG. 3 shows a further workflow according to the invention of a dual-energy image acquisition, image processing and presentation, beginning with the contrast agent administration, wherein two different volume segments are examined. [0079] FIG. 4 shows a different workflow according to the invention of a dual-energy image acquisition, image processing and presentation, beginning with the contrast agent administration, wherein two different volume segments are examined. [0080] FIG. 5 shows a workflow according to the invention for the generation of two-dimensional images during a high-energy tomosynthesis scan. [0081] FIGS. 6 a and 6 b together show a flow chart of a method according to the invention. DESCRIPTION OF THE PREFERRED EMBODIMENTS [0082] A tomosynthesis apparatus 30 according to the invention for mammography examinations is schematically shown in FIG. 1 . The tomosynthesis apparatus 30 has a support arm 9 that is mounted such that it can pivot in a bearing around a horizontal axis A (see double arrow and angle α). The bearing is arranged on a stand 3 and can be vertically adjusted as indicated with the double arrow b. An arm 6 provided with an x-ray source 5 , a flat panel detector 7 and a compression device (consisting of a compression plate 10 and a support plate 11 ) are arranged on the support arm 9 . Schematically shown in FIG. 1 is a female breast 12 compressed by the compression plate 10 and the bearing plate 11 . The arm 6 can pivot around the axis A relative to the support arm 1 , the detector 7 and the compression device 10 , 11 . Electromotors 13 through 15 of the tomosynthesis apparatus 30 are provided for height adjustments and pivot motions. [0083] A control of the tomosynthesis apparatus 30 takes place via an operating device 6 of the tomosynthesis apparatus 30 which is connected with a controller 17 and an image computer 22 of said tomosynthesis apparatus 30 . Specific methods (among these the methods according to the invention) can be loaded into the controller 17 and the operating device 16 by means of a DVD 21 . [0084] A basic workflow according to the invention of a dual-energy image acquisition, image processing and image presentation is shown in FIG. 2 , beginning with the contrast agent administration. After the administration of the contrast agent, the acquisition of a two-dimensional low-energy image 1 of the female breast (of the predetermined volume segment) most often takes place in the form of a standard screening projection (CC or MLO). Multiple two-dimensional high-energy images 2 are subsequently generated with the same acquisition angle (CC or MLO) of the female breast. A registration of the low-energy image 1 with a respective one of the high-energy images 2 takes place using earlier low-energy images 31 of the same breast of the patient. After this registration 8 the low-energy image 1 is subtracted from each of the high-energy images 2 , so a dual-energy image (difference image) results for each subtraction. This subtraction is also designated as a non-temporal dual-energy subtraction. The concentration of the contrast agent is visible in each of these difference images, such that the contrast agent course results from the multiple difference images. [0085] The acquisition of the two-dimensional low-energy image 1 and the acquisition of the two-dimensional high-energy images 2 take place in the enrichment phase of the contrast agent since the generation of the two-dimensional images 1 , 2 can take place fast enough in order to generate these two-dimensional images 1 , 2 even given a temporally short enrichment phase of only 10 s. [0086] After the creation of the two-dimensional high-energy images 2 (approximately 2 to 4 minutes after the contrast agent administration), a high-energy tomosynthesis 4 of the same breast is implemented. With the use of the two-dimensional low-energy image 1 , the image data resulting from the high-energy tomosynthesis 4 are registered with image data of an earlier low-energy tomosynthesis 18 implemented with regard to the same breast. [0087] After the registration 38 , the image data of the high-energy tomosynthesis 4 that are created from different tomosynthesis angles are adapted to one another such that a three-dimensional image data set of the female breast is created. A subtraction 39 subsequently occurs in which the image data of the earlier low-energy tomosynthesis 18 are subtracted from the image data of the high-energy tomosynthesis 4 , which is also known as a temporal dual-energy subtraction. [0088] The high-energy tomosynthesis 4 occurs in the wash-out phase in which the contrast agent flows out of the lesions or tumors, such that the concentration of the contrast agent decreases. This wash-out phase normally has a smaller (negative) slope of the contrast agent concentration per time unit in comparison to the (positive) slope of the contrast agent concentration in the enrichment phase, such that more time is available to implement the high-energy tomosynthesis. [0089] An additional workflow according to the invention of a dual-energy image acquisition, image processing and presentation is shown in FIG. 3 , beginning with the contrast agent administration, wherein two different volume segments (both breasts) are examined. [0090] After the administration of the contrast agent, a two-dimensional low-energy image is first created from the right breast of the patient and multiple two-dimensional high-energy images 2 are subsequently created. The right breast is subsequently released and a two-dimensional low-energy image 1 ′ (and following this multiple two-dimensional high-energy images 2 ′) of the left breast is created. After the generation of the two-dimensional high-energy images 2 ′, a high-energy tomosynthesis scan 4 ′ of the left breast is implemented. The left breast is subsequently released and a high-energy tomosynthesis scan 4 of the right breast is implemented. [0091] With the method shown in FIG. 3 , both breasts of a patient can accordingly be examined with the with the same administration of a contrast agent. Since a low-energy image 1 , 1 ′ of multiple high-energy images 2 , 2 ′ and a high-energy tomosynthesis scan 4 , 4 ′ are thus created both for the right breast and for the left breast, a non-temporal dual-energy subtraction 9 and a temporal dual-energy subtraction 39 can be implemented for both the right breast and the left breast, as is shown in detail for one breast in FIG. 2 . [0092] A variant of the workflow according to the invention shown in FIG. 3 for the examination of both breasts is shown in FIG. 4 . In comparison to the workflow shown in FIG. 3 , the generation of the two-dimensional high-energy images 2 , 2 ′ of the right and left breast is missing in the workflow shown in FIG. 4 , so the generation of the two-dimensional images 1 , 1 ′ takes place more quickly and the high-energy tomosynthesis scan 4 , 4 ′ can be started faster. The two-dimensional high-energy images 2 ′ of the left breast are generated during the high-energy tomosynthesis scan 4 ′ of the left breast while the two-dimensional high-energy images 2 of the right breast are generated during the high-energy tomosynthesis scan 4 of the right breast. [0093] A variant of the embodiment shown in FIG. 2 is depicted in FIG. 5 . In the embodiment shown in FIG. 5 , the high-energy tomosynthesis scan 4 begins directly after the administration of the contrast agent. The two-dimensional low-energy image 1 and the multiple two-dimensional high-energy images 2 are generated during this high-energy tomosynthesis scan 4 . [0094] A flow chart diagram of an embodiment of the method according to the invention is presented in FIG. 6 a. [0095] In a first Step S 1 , a contrast agent is administered to the patient before the breast to be examined is positioned between the bearing plate and the compression plate in a second Step S 2 . These two first Steps S 1 and S 2 can also be swapped in terms of their order so that the contrast agent is only administered when the breast to be examined is already positioned between the bearing plate and the compression plate. [0096] In the following Step S 3 a two-dimensional low-energy image is subsequently generated with a correspondingly low x-ray energy as quickly as possible after the administration of the contrast agent. During the enrichment phase of the contrast agent in possible tumors and lesions present in the breast, multiple two-dimensional high-energy images are generated with a correspondingly high x-ray energy in Step S 4 . [0097] Since the generation of the two-dimensional images (mammography) is concluded, in Step S 5 the detector is switched over from two-dimensional mode into a tomosynthesis mode. In Step S 6 a high-energy tomosynthesis scan is subsequently implemented with a correspondingly high radiation energy in order to generate image data of the wash-out phase of the contrast agent before the breast is released in Step S 7 . [0098] The processing of the images or image data generated in Steps S 1 through S 7 takes place in the Steps shown in FIG. 6 b . Steps S 8 through S 12 can thereby also be implemented in a different order than as shown in FIG. 6 b insofar as the registration of the corresponding images or image data occurs before a reconstruction or subtraction of these images or image data. Moreover, Steps S 8 through S 12 do not need to occur after Steps S 1 through S 7 ; rather, these can be interleaved with these Steps S 1 through S 7 insofar as the images or image data required for a processing Step S 8 through S 12 are created beforehand via the corresponding generation Steps S 3 , S 4 , S 6 . [0099] In Step S 8 the two-dimensional low-energy image 1 is registered with each of the high-energy images 2 , wherein this registration is implemented depending on a three-dimensional low-energy image created before the administration of the contrast agent. In Step S 9 the low-energy image is subsequently subtracted from each high-energy image, whereby a number of dual-energy images or reference images is created which corresponds to the number of two-dimensional high-energy images. The respective subtraction of the low-energy image from the respective high-energy image is also designated as non-temporal dual-energy subtraction. [0100] In Step S 10 the image data of the high-energy tomosynthesis scan are registered with image data of a low-energy tomosynthesis scan implemented before the administration of the contrast agent, wherein this registration is implemented depending on the two-dimensional low-energy image generated in Step S 3 . In Step S 11 , three-dimensional image information of the examined breast is reconstructed from the projections generated in the high-energy tomosynthesis scan. Arbitrary slice images (with arbitrary viewing angles) of the examined breast can be generated with the aid of this three-dimensional image information. To show the contrast agent concentration or the course of the contrast agent concentration in the wash-out phase, the image data of the earlier low-energy tomosynthesis scan are subtracted from the image data of the high-energy tomosynthesis scan (which is also known as a temporal dual-energy subtraction). [0101] Although modifications and changes may be suggested by those skilled in the art, it is the intention of the inventors to embody within the patent warranted hereon all changes and modifications as reasonably and properly come within the scope of their contribution to the art.

1a

BACKGROUND OF THE INVENTION This invention relates to a low profile device for treatment of vascular abnormalities, such as the repair of aneurysms. In the past, treatment of aneurysms involved an open surgical procedure which exposed the affected lumen and bypassing the aneurysm with an artificial tubular graft. More recently stent grafts have been employed as a minimally invasive alternative to traditional graft bypass surgery. There are a number of stent graft designs that have been tried. Current designs are limited to use with patients having large vessels because of the large size of the delivery systems. Such large sizes require surgical exposure of the vascular system and in smaller patients, often females, such stent grafts are simply too large to use at all. In addition, such larger stent graft designs can be difficult to position and may cause damage to the blood vessels. SUMMARY OF THE INVENTION It is an object of the present invention to provide a stent graft design that has a low cross sectional profile that can be delivered percutaneously and used in patients with small and tortuous vessels. It is a further object to provide a stent graft that is highly flexible. It is a still further object to provide a stent graft that is simple and inexpensive to construct. These and other objects are achieved by providing a stent graft that has a minimal metallic endoskeleton that holds the graft material in place until secondary deployment of additional stents. Such a minimal metallic endoskeleton allows the delivery system to have a lower cross-sectional profile than conventional stent grafts. The endoskeleton of the stent graft of this invention has a first self expandable metallic stent located at the distal end thereof and a second self expandable metallic stent located at the proximal end thereof. At least one flexible longitudinal strut member extends between and is connected to the first and second stents. The strut member can have a fixed length or can be a compound strut comprised of two or more strut sections that are fastened together in a manner that allows a sliding motion between the strut sections so that the compound strut can be elongated by applying traction to the proximal stent. The endoskeleton of the stent graft of this invention may be bifurcated for use with aneurysms of the abdominal aorta. The endoskeleton of the stent graft of this invention is inserted into a tube of a graft material and the tube attached to the first and second stents. In the case of the bifurcated system, the graft material is also connected to the third contralateral stent. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a plan view of a straight tubular form of the endoskeleton of the stent graft of the present invention; FIG. 2 is a plan view of a portion of a stent used in the invention; FIG. 3 is a plan view, partially in section, of the straight tubular form of the endoskeleton attached to the inside a tubular graft; FIG. 4 is a plan view of a bifurcated form of the endoskeleton of the stent graft of the present invention; FIG. 5 is a plan view, partially in section, of the bifurcated form of the endoskeleton attached to the inside of a tubular graft; and FIG. 6 is a partial plan view of the bifurcated stent attached to a two component strut to permit sliding elongation, shown in its collapsed condition; FIG. 7 is a partial plan view of the strut of FIG. 6 shown in its extended condition; and FIG. 8 is a plan view of the bifurcated stent of the FIG. 6 embodiment shown with tubular graft material attached thereto. DESCRIPTION OF PREFERRED EMBODIMENTS The endoskeleton 10 of the straight tubular form of stent graft 30 is illustrated in FIG. 1 . Endoskeleton 10 is comprised of a first stent 12 and a second stent 14 . Stents 12 and 14 are identical in construction, each being a cylindrical spring assembly made from a single piece of fine gauge stainless steel spring wire or nitinol having a diameter of about 0.4 to 0.5 mm that is bent into a sinusoidal configuration comprised of a plurality of arms 16 and outer and inner elbows 18 and 19 , respectively, as best seen in FIG. 2 . Elbows 18 and 19 are illustrated as being simple arches, but other elbow configurations, such as a recurved arch or aperatured arch may be used. Struts 20 , 21 , and 22 extend between first and second stents 12 and 14 , as shown. Struts 20 - 22 are constructed of fine gauge stainless steel spring wire or nitinol having a diameter of about 0.3 to 0.6 mm. Struts 20 - 22 are attached to stents 12 and 14 in any suitable manner, such as soldering to outer elbows 18 at solder joint 24 ; they may, alternatively be attached by bending, or cut from a single piece of metal. The struts are substantially evenly spaced apart around cylindrical stents 12 and 14 . Although three struts are preferred, a single strut may be used. More than three struts may also be used, but the number used should not be such that the flexibility of the stent graft is compromised. A straight tubular stent graft 30 is formed by compressing stents 12 and 14 and inserting endoskeleton 10 into elongated cylindrical graft tube 31 , as best seen in FIG. 3 . The graft tube 31 is attached to stents 12 and 14 by sutures 32 passed through graft 31 and outer elbows 18 . Graft tube 31 may be formed of any conventional graft material which is known to be substantially biologically inert, non-biodegradable, and durable. A suitable such graft material is polytetrafluoroethylene (“PTFE”) sold under the trademark “IMPRA” by Bard of Tempe, Arizona. The diameter of the graft tube 31 can be between about 6 and about 40 mm in diameter and between about 1.5 and about 400 mm in length. The endoskeleton 40 of a bifurcated form of stent graft 60 of this invention is illustrated in FIG. 4 . Endoskeleton 40 is comprised of a first stent 42 and a second stent 44 having struts 46 , 47 , and 48 extending therebetween and attached thereto in the same manner as for the straight tubular form 10 discussed above. Stents 42 and 44 are cylindrical spring assemblies of the same configuration and material as discussed above, except that stent 42 has approximately twice the diameter of stent 44 . Stent 50 is attached to stent 42 by means of a single strut 52 . Bifurcated stent graft 60 is formed by positioning a partially compressed bifurcated endoskeleton 40 inside a bifurcated tubular graft 61 as shown in FIG. 5 . Graft 61 is formed of the same material as graft 31 . Stent 44 is located inside, and adjacent the end of, channel 62 and sewn to graft 61 by sutures 63 , only two of which are shown. Stent 44 is in a partially compressed state so that an outward force is applied to the inner side of channel 62 . Stent 50 is located inside, and adjacent the end of, channel 64 and sewn to graft 61 by sutures 65 , only two of which are shown. Stent 50 is in a partially compressed state so that an outward force is applied to the inner side of channel 64 . Stent 42 extends outwardly from the end of channel 66 and is sewn to graft 61 by sutures 67 , only two of which are shown. Being in a partially compressed state at its inner end, stent 42 exerts an outward force on the inner side of channel 66 . Stent 42 is not covered by graft material 61 to allow placement of the stent graft 60 across critical branch vessels without causing occlusion, the blood flowing through the open structure of the uncovered stent. This is especially true in the abdominal aorta where the renal arteries are just above the level of the aneurysms. An uncovered stent 42 can be placed safely across the origins of the renal arteries and still allow a fixation site for the stent graft 60 . Graft material 61 is configured to wrap around stent 50 and is sewn along stitch line 68 to form channel 64 . There is no communication between channel 62 and channel 64 along the stitch line 68 , but both channels 62 and 64 communicate with channel 66 . Bifurcated stent graft 60 is used to repair aneurysms of the abdominal aorta which typically occur where the aorta branches into smaller (iliac) arteries. Bifurcated stent graft 60 can be used in conjunction with the straight tubular stent graft 30 described above by inserting straight tubular stent graft 30 into channel 64 of bifurcated stent graft 60 and sewing it into place. The end of bifurcated stent graft 60 containing channel 66 is located in the aorta with channel 50 (extended by insertion of a stent graft 30 ) and channel 62 being located in the adjacent iliac arteries. A variation of the endoskeleton of bifurcated stent graft 60 is shown in FIGS. 6 and 7. In this variation, single strut 52 of FIG. 4 is replaced by a two component strut comprised of fixed strut 152 and sliding strut 252 . Fixed strut 152 is attached to stint 142 and sliding strut 252 is attached to stint 150 , the reference numbers of the components in FIGS. 6 and 7 common to those in FIG. 4 being the same but increased by 100 or, in the case of the sliding strut, by 200. Sliding strut 252 has a ring 254 attached at its outer end. Ring 254 fits over fixed strut 142 in sliding relationship. In FIG. 6 sliding strut 252 is shown in its unextended (collapsed) configuration. In FIG. 7 sliding strut 252 is shown in its extended configuration. Cap 154 attached to the outer end of fixed strut 152 prevents passage of ring 254 thereover. FIG. 8 illustrates the bifurcated configuration employing the sliding strut configuration illustrated in FIGS. 6 and 7. In other respects, the bifurcated configuration of FIG. 8 is the same as the bifurcated configuration illustrated in FIG. 5, and identical components of the FIG. 8 configuration have the same reference numbers as those used in FIG. 5, but increased by 100. In FIG. 8, the sliding strut 152 / 252 (not shown) is in the collapsed configuration shown in FIG. 6 . That portion of graft 161 covering sliding strut 152 / 252 and stent 150 is collapsed, accordion style, since it must have a length long enough to accompany stent 150 (to which it is attached by sutures 165 ) as strut portion 252 is extended. The endoskeletons of both the straight stent graft 30 and bifurcated stent graft 60 are easily compressed into a small diameter endoprosthesis package for percutaneous delivery to the required aneurysm repair site since a minimum number of stents are employed (two in straight stent graft 30 and three in stent graft 60 ). For example, straight stent graft 30 can be collapsed to a diameter of about 3.3 mm and bifurcated stent graft 60 can be collapsed to a diameter of about 4.0 mm. The stent grafts 30 and 60 of the invention are introduced through a conventional sheath with a hemostatic valve. The sheath and taper dilator is initially positioned over an intravascular guide wire. The tapered dilator is removed and the stent graft is advanced through the sheath with a blunt pushing device. The distal tip of the sheath is demarcated with a radiopaque marker. After stent graft 30 or stent graft 60 is secured in place in the artery of a patient, additional (secondary) stents can be inserted inside the graft tube along the length thereof.

1a

[0001] This application is a formal application claiming the priority of provisional U.S. patent application No. 61/148,391, filed Jan. 30, 2009, the specification of which is incorporated by reference herewith in its entirety. TECHNICAL FIELD [0002] This invention relates to massage tools. More specifically, it relates to such tools that are ergonomically designed so that they can be used to massage with a reduced muscle fatigue of the massage therapist. DISCUSSION OF PRIOR ART [0003] Massage services are in high demand worldwide. However, performing a massage is physically demanding both in term of physical energy as well as wear and tear of therapist's hands, wrists, arms and shoulders. Repetitive motion problems are amongst the most common. [0004] There are many kinds of massage assisting tools. These include massage chairs, pillows, beds, mattresses, massage bath tubs, massage belts, vibrators etc.; various accessories and implements such as massage balls, massage thumps, massage rollers, etc. are also known. Examples of such products are described in the following U.S. patents and patent applications: U.S. Pat. No. 7,431,706, issued Oct. 7, 2008 to Louis, U.S. Pat. No. 7,252,645, issued Aug. 7, 2007 to Polins, U.S. Pat. No. 7,179,240, issued Feb. 20, 2007 to Wu, U.S. Pat. No. 7,141,030, issued Nov. 28, 2006 to Chen, U.S. Pat. No. 6,267,738, issued Jul. 31, 2001 to Louis, U.S. Pat. No. 6,241,694, issued Jun. 5, 2001 to Goulding-Thompson et al., U.S. Pat. No. 6,010,469, issued Jan. 4, 2000 to McAtee, U.S. Pat. No. 5,624,385, issued Apr. 29, 1997 to Hwang, U.S. Pat. No. 5,382,222, issued Jan. 17, 1995 to Yih-Jong, U.S. Pat. No. 4,483,328, issued Nov. 20, 1984 to Wolocko, U.S. Pat. No. 3,545,434, issued Dec. 8, 1970 to Woodruff, U.S. Pat. No. 5,868,689, issued Feb. 9, 1999 to Faroky et al., U.S. Pat. No. 5,843,005, issued Dec. 1, 1998 to Chubinsky, 20050159689, issued Jul. 21, 2005 to Olson, 20040249324, issued Dec. 9, 2004 to Louis, 20040230147, issued Nov. 18, 2004 to Fretterd. [0021] There are also systems involving transmission of energy and allowing a change of massage applicators. Examples of such products are shown in the following U.S. patents: U.S. Pat. No. 7,354,408, issued Apr. 8, 2008 to Muchisky, U.S. Pat. No. 7,229,424, issued Jun. 12, 2007 to Jones et al., U.S. Pat. No. 7,175,592, issued Feb. 13, 2007 to Lee, U.S. Pat. No. 6,988,997, issued Jan. 24, 2006 to Stultz, U.S. Pat. No. 6,758,826, issued Jul. 6, 2004 to Luettgen et al. U.S. Pat. No. 6,735,808, issued May 18, 2004 to Chen, U.S. Pat. No. 6,585,668, issued Jul. 1, 2003 to Nissim, U.S. Pat. No. 6,332,873, issued Dec. 25, 2001 to Naruse et al., U.S. Pat. No. 6,267,737, issued Jul. 31, 2001 to Meilus, U.S. Pat. No. 6,241,693, issued Jun. 5, 2001 to Lambden, U.S. Pat. No. 5,187,827, issued Feb. 23, 1993 to Wei, U.S. Pat. No. 4,919,117, issued Apr. 24, 1990 to Muchisky et al., U.S. Pat. No. 4,102,334, issued Jul. 25, 1978 to Muchisky, U.S. Pat. No. 4,098,266, issued Jul. 4, 1978 to Muchisky et al. [0036] There are also devices/systems using gravity as energy for massaging. Examples of such products are shown in the following U.S. patents: U.S. Pat. No. 7,320,668, issued Jan. 22, 2008 to Warder, U.S. Pat. No. 6,217,121, issued Apr. 17, 2001 to Mollet, U.S. Pat. No. 5,913,839, issued Jun. 22, 1999 to Wincek, U.S. Pat. No. 1,265,083, issued May 7, 1918 to Hoard. [0041] While each of the above-noted developments is useful, there is still a need to reduce physical stress on massage therapists' hands, wrists, arms and shoulders. OBJECTS OF THE INVENTION [0042] Accordingly, it is an object of the invention to provide an ergonomic massage tool the use of which is relatively easy on therapist's hands, wrists, arms and shoulders by reducing the stress on and in them while providing an effective massage. [0043] Further objects and advantages of the invention will become apparent from a consideration of the ensuing description and drawings. SUMMARY OF THE INVENTION [0044] In accordance with one aspect of the invention, there is provided a massage tool which comprises a shank coupled with a user's body support and with a massage applicator spaced from the body support by a predetermined distance. [0045] In an embodiment of the invention, the massage tool comprises a shank having a predetermined length, the shank having a first end adapted for engaging a user's (massage therapist's) shoulder, upper arm or vicinity, and a distal second end coupled with a massage applicator. [0046] In one embodiment, the first end is coupled with a body engagement structure and the distal end is coupled with a massage applicator (a body contact head). [0047] In one embodiment, the shank comprises means for adjusting its length according to the massage therapist's size, personal preference and ergonomic considerations. The shank may be extendible and/or retractable. In one embodiment, the shank is foldable. In one embodiment, it is made of separable components for easy storage and/or transportation. [0048] In an embodiment of the invention, the shank comprises at least one hand grip portion. The portion may be of a size and shape to facilitate manipulation of the shank during a massage. [0049] In one embodiment, the hand grip portion is disposed at an angle relative to the longitudinal axis of the shank, the angle selected according to ergonomic considerations. [0050] Preferably, the shank is rigid enough to transfer a force from the massage therapist's body to the recipient's body, the force sufficient for massage purposes. The shank may be made of a material exhibiting a degree of flexibility and/or may comprise a compressible mechanism, e.g. a shock absorber, so as to counteract a possibility of the user's excessive force, if any, applied through the user's body during the therapy. [0051] The contact heads may be removable from said distal end of the shank and interchangeable. [0052] According to another aspect of the invention, there is provided a method for performing a massage using a tool comprising a shank having a first end coupled with a user's body support and with a massage applicator spaced from the body support by a predetermined distance, the method comprising the steps of a) contacting the applicator with the massage recipient's body, b) applying a pressure with the body through the body support and the shank onto the massage applicator with a force selected to perform a massage therapy, and c) moving the shank with the applicator on a massage recipient's body to perform the massage. [0056] For the purpose of the present specification, the term “shank” denotes any structure, elongated or not, suitable to be coupled with a body support and a massage applicator. [0057] According to another aspect of the invention, there is provided a method for performing a massage using a tool comprising a shank having a first end coupled with a user's body support and with a massage applicator spaced from the body support by a predetermined distance, the method comprising the steps of d) contacting the applicator with the massage recipient's body, e) applying a pressure with the body through the body support and the shank onto the massage applicator with a force selected to perform a massage therapy, and f) moving the shank with the applicator on a massage recipient's body to perform the massage. [0061] For the purpose of the present specification, the term “shank” denotes any structure, elongated or not, suitable to be coupled with a body support and a massage applicator. BRIEF DESCRIPTION OF THE DRAWING FIGURES [0062] Preferred embodiments of the invention will now be described with reference to the accompanying drawings, in which: [0063] FIG. 1 . a is a front view of an embodiment of the massage tool; [0064] FIG. 1 . b is a front view of another embodiment of the massage tool; [0065] FIG. 1 . c is a front view of yet another embodiment of the massage tool; [0066] FIG. 1 . d is a front view of yet another embodiment of the massage tool; [0067] FIG. 2 a is an illustration of the use of the massage tool of the invention; [0068] FIG. 2 b is another illustration of the use of the massage tool; [0069] FIG. 3 is a front view of the body support; [0070] FIG. 4 is a cross-section along the lines A-A of the body support of FIG. 3 ; [0071] FIG. 5 shows a side view of another embodiment of the tool without a massage applicator; [0072] FIG. 6 shows a sectional front view of an applicator holder; [0073] FIG. 7 a is a front view of an exemplary massage applicator; [0074] FIG. 7 b is a side view of the applicator of FIG. 7 a; [0075] FIG. 8 a is a perspective view of another massage applicator; [0076] FIG. 8 b shows a front view of the applicator of FIG. 8 a; [0077] FIG. 9 is a perspective view of yet another massage applicator; [0078] FIG. 10 a is a perspective view of still another massage applicator; [0079] FIG. 10 b illustrates a front view of the applicator of FIG. 10 a ; and [0080] FIG. 11 illustrates still another embodiment of a massage applicator. DETAILED DESCRIPTION [0081] FIG. 1 . a illustrates one embodiment of the massage tool of the invention. The tool, generally designated as 10 , has a shank 12 which is connected with a body support 14 through a pivotable connection 16 enabling the body support, in operation of the tool, to adapt to the curvature of the user's body. The shank has a longitudinal axis 18 . At the end of the shank 12 opposite to the body support, a massage applicator 20 is coupled to the shank 12 using a known mechanical connection. In FIG. 1 . a, the applicator is a wheel mounted to a holder 22 which is in turn threadedly connected to the shank 12 . [0082] The shank has a grip portion 24 which is bent at an angle to the axis 18 to facilitate hand grip for ergonomic reasons. Alternatively, the shank may be shaped to form two hand grip portions (not illustrated). [0083] The shank should be lightweight to reduce the user's fatigue in operation. It may be made of metal or another material, e.g. a polymer. It may have a degree of flexibility to reduce the possibility of discomfort or injury of the massage recipient in case of application of excessive force by the user of the tool during massage. [0084] The length of the shank 12 can be adjusted to suit the size and preference of the user (distance from the user's shoulder to the massage recipient's body may vary) and/or therapy requirements. The length adjustment means are schematically represented at 26 . They may be exemplified by a separable segment of the shank or an extendible portion thereof. [0085] The shank 12 may comprise at least one compressible mechanism, e.g. a well-known spring-loaded shock absorber (not illustrated) so as to counteract a possibility of the user's excessive force, if any, applied through the tool during the therapy. [0086] FIG. 1 . b illustrates another embodiment of the massage tool of the invention. The grip portion is placed in between two elongated elements of a crutch-like shank 12 for improved grip or for providing alternative grip options for various users. [0087] FIG. 1 . c illustrates another embodiment of the massage tool of the invention. The grip portion is placed at one side of the shank 12 for improved grip or for providing alternative grip options for various users. [0088] FIG. 1 . d illustrates another embodiment of the massage tool of the invention. The grip portion is placed at both sides of the shank 12 for improved grip or for providing alternative grip options for various users. [0089] FIG. 2 a is an illustration of the use of the massage tool of the invention. A massage therapist (also synonymously referred to as a user in the specification) holds the tool 10 so that one end of the tool (the applicator end) contacts the body of a prone massage recipient and the other end, with a body support, rests against the therapist's shoulder or a shoulder area. The body support may be placed in the armpit, against the shoulder joint, against the upper arm or anywhere in the vicinity, the purpose being for the user to apply a force with the user's upper body onto the applicator end and thereby reduce the energy use by hand and arm muscles. In the FIG. 2 a , the body support is shown for simplicity as resting against the shoulder joint of the user. In FIG. 2 b , the body support rests against the user's upper arm. [0090] For clarification, the term “body support” denotes herein an element of the tool of the invention that can be shaped and sized to be used as either the top of a crutch (when placed in the armpit of the user) or as a rifle butt (when placed against the shoulder or in the vicinity thereof). [0091] FIGS. 3 and 4 show the body support in more detail. [0092] As shown in FIG. 5 , the shank can be assembled from two parts for easy storage and transportation, element 28 denoting a temporary connection e.g. a bayonet connection. Alternatively, the shank may be foldable, wherein the element 28 would denote a suitable joint, known in the mechanical art. [0093] The applicator 20 is mounted on the shank using an applicator holder 22 shown in detail in FIG. 6 . The upper part 34 of the holder 30 is threaded into the lower part of the shank 12 ( FIG. 1 ) or connected thereto using alternative suitable means. [0094] FIGS. 7 a , 7 b , 8 a , 8 b , 9 , 10 a , 10 b and 11 illustrate various applicators which can be used in connection with the tool of the invention. The applicators may be ball tips, wheels, rollers, contact heads with two contact points ( FIG. 11 ) for areas like the soft tissues along the two sides of the spine, or other massage applicators known in the prior art. [0095] The element in FIG. 9 may be incapable of rolling but has a soft surface to allow user to place their hand, finger or fingers underneath on patient's body to, at one hand, maintain palpation, i.e. feeling the patient's muscles, and on the other hand, applying force from the user's shoulder, armpit, trunk, other upper arm or the palm of the other hand as opposed to from the user's fingers or edges of the hand, hence reduce the stress on the user's fingers and hand. The diameter should be large enough to minimize the pressure on user's hand, finger or fingers, but small enough to be easily manipulate-able. An good compromised diameter would be about 1 inch. The length of the element should be long enough to be able to cover 1 to 4 fingers, and should short enough to be easily manipulate-able. A reasonable compromised length would be 2-3 inches. The soft surface can be made of, for example but not limited to, soft rubber layer, soft polyurethane layer, sturdy foam layer, or any such material know in the art, to protect the user's hand, finger or fingers and to allow greater degree of comfort possible. In such situation, the user will first place one hand, finger or fingers at desired spot on patient's body, then place the soft-surfaced element according to FIG. 9 on the hand, finger or fingers, then apply strength from their upper body such as shoulder, while sensing patient's muscle or muscles with the hand, finger, or fingers on patient body and using the other hand stabilize the massage tool 10 and guide the application of the strength from the user's upper body. [0096] In operation, as illustrated in FIGS. 2 a and 2 b , the therapist places the massage applicator on desired location of patient's body and applies a suitable amount of pressure onto patient's body by pressing on the body support 14 of the massage tool 10 . The therapist guides the shank of the tool with hand and shoulder, while controlling the pressure applied on the body support. [0097] Although the description above contains many specifics, these should not be construed as limiting the scope of the invention but as merely providing illustrations of some of the presently preferred embodiments of this invention. For example, the body support may have other shapes and structure or it may be connected with the shank in a manner allowing the pivotal motion in many planes; the extended rigid structure may have other shapes than illustrated; the applicator connection to the tool may be effected in many ways; the applicator may be integral with the tool; the applicators may have various shapes, dimensions, textures, hardness to suit various therapeutic needs; the shank or other components of the tool may be equipped with oscillatory motor/mechanism to allow massage applicator to vibrate to provide further therapeutic benefits. [0098] Thus the scope of the invention should be determined by the appended claims and their legal equivalents, rather than by the examples given.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates to electric or electronic animal traps, and relates more particularly to an animal trap adapted to catch and electrocute a targeted animal simultaneously stepping on a pair of spaced electrodes, with means designed to direct a targeted animal entering the trap housing into and through a pathway leading to a source of bait beyond the electrodes while minimizing the likelihood that the animal will back out or escape from the trap before engaging the electrodes, and while precluding accidental contact with the electrodes by a user, a pet or non-targeted animal that could inadvertently fire the trap. Although the concepts of the instant invention are equally applicable to traps for animals of any size, devices of this type are primarily utilized in connection with the trapping of rodents such as mice and rats and the description will, therefore, focus on this application. 2. The Prior Art Animal traps have been around for hundreds of years and include many different designs. Most common is the typical rodent snap trap that utilizes a spring and a snapping bar to kill the target animal. These designs can be unpleasant to handle and pose a danger to the consumer setting the trap. Due to these problems, many other types of animal traps, particularly rodent traps, have been utilized. One alternative to the snap trap is to use electricity to kill the target animal. Traps of this nature are typically easier to set and do not produce an unsightly result when the consumer catches a rodent or the like. However, other issues such as safety and efficacy can be a concern. Professional pest control companies have complained of possible dangers in using such traps; additionally, it is not uncommon for target animals to avoid electrocution by backing out of the trap. Attempts to avoid these problems have been less than successful. In U.S. Pat. No. 5,269,091 to Johnson et al., a flexible plate is charged with a base plate. When the pest enters the trap, the pest presses the flexible plate into contact with the base plate. This contact completes the circuit and a high voltage is applied to the pest. The problem with this type of device is that voltage only occurs when the pest makes contact with the flexible plate. When the pest is initially shocked it may move and fail to receive sufficient voltage to exterminate it. Johnson et at. U.S. Pat. No. 5,949,636 discloses a portable pest electrocution device with a resistive switch to sense the presence of a pest between a pair of electrodes. One of the electrodes is set at a high voltage and the other is set to ground. The ground electrode is a separate stake shaped electrode which is placed physically in the ground. When the pest enters the trap, contact is made, and a timer begins for a set period of time. After timing out, the timer deactivates the power to the electrodes. A problem with this device is that a separate ground stake is necessary. It is costly and cumbersome. If the user forgets or misplaces the separate ground stake, the device does not work correctly and thus will be useless. The subject matter of the Johnson et al. patents is incorporated herein in its entirety by reference. Copending, commonly assigned, U.S. Pat. No. 6,609,328 issued Aug. 26, 2003 (the '328 patent), the subject matter of which is also incorporated herein by reference in its entirety, overcomes many of the problems associated with the Johnson et al. patented products by providing an electric or electronic trap of the inclined plane or teeter-totter type wherein the target animal entering the trap passes over the fulcrum of a tilting floor or platform and closes a circuit initiating an electrical shock to kill the animal. While the '328 patent discloses improved circuitry for such an animal trap, the mechanical aspects of tilting floor traps, while effective, require significant design features to insure the targeted animal does not escape before it engages the electrodes and to preclude accidental engagement with the electrodes by a less sophisticated or curious person such as a young child. Other prior art electric or electronic traps are particularly complicated and costly to manufacture making them poor candidates for mass marketing. Deficiencies in their reliability and safety features have also minimized the commercialization of devices of this nature. SUMMARY OF THE INVENTION A primary object of this invention is to provide an animal trap, particularly a mouse or rat trap, which will quickly and efficiently electrocute a targeted animal, is simple and inexpensive to manufacture and highly reliable and completely safe in use. A further object of this invention is the provision of an inclined plane electric or electronic animal trap such as disclosed in the '328 patent modified to incorporate a diverter plate or the like making it difficult for an animal stepping from an electrified platform which functions as a first electrode to reverse direction as it contacts the second electrode at the end of the platform. Another object of this invention is to provide an electric or electronic animal trap utilizing, if desired, the improved circuitry of the '161 application, but modifying the mechanical structure of the device to eliminate the sometimes problematic operation and effectiveness of the inclined plane or tilting floor design disclosed in the '161 application, and replacing the same with a fixed barrier or diverter system that has no moving parts and, while minimizing or preventing escape of the animal, totally precludes the accidental simultaneous engagement of the electrodes and actuation of the circuitry by blocking the pathway between the entrance opening and at least the second electrode to preclude the introduction of an extraneous element by an inexperienced or curious user. Yet another object of this invention is to provide a mouse or rat trap comprising at least a pair of spaced, oppositely angled, barrier elements immediately within the entrance opening, diverting a target animal into a maze-like path as it passes into the trap because of its innate curiosity or to seek a quantity of bait, such as peanut butter or the like, positioned beyond the electrodes. Once the animal passes the first barrier, it no longer sees the opening and is encouraged to simply move forward, rather than to attempt to back out or escape from the trap before engaging and actuating the electronic circuitry. The same barrier system that minimizes the likelihood of escape of the target animal also bars the entry of a relatively straight element such as screwdriver or a child's finger that could accidentally close the circuit and injure the trap user and/or damage the trap. A further object of this invention is to provide a trap of the type described either with the angled diverters or the inclined plane, but incorporating a plate or the like extending downwardly from the housing cover intermediate the spaced electrodes that provides limited space between its lower edge and the floor of the housing to force a target animal to squeeze thereunder making it more difficult for the animal to reverse itself when it contacts the second electrode. A still further object of this invention is to incorporate a pair of cooperating diverters or barriers, one extending partway down to the floor from the cover and the other extending partway up from the floor toward the cover which together block direct access to the electrodes by a straight element inserted through the entrance opening. From the foregoing, it is obvious that the instant invention provides an electric or electronic animal trap which, in all embodiments, is highly efficient and reliable, providing excellent protection against inadvertent or accidental damage to the user of the trap or the trap itself. Other and further objects of this invention will be readily understood by those with ordinary skill in the art with particular reference to the following detailed description of the preferred embodiments in combination with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is an exploded view of a general housing design for the various embodiments of trap assemblies according to this invention; FIG. 2 is a top plan view of the base of one preferred embodiment of an animal trap according to the instant inventive concepts with the cover and electronic components removed for illustrative clarity; FIG. 3 is a perspective view of the trap housing base of the embodiment of FIG. 2; FIG. 4 is a perspective view of the trap housing base of the embodiment of FIG. 2 from another angle; FIG. 5 is a perspective view of a modified cover for a trap housing according to this invention carrying a diverter or barrier which extends into the trap intermediate the spaced electrodes when the cover is closed; FIG. 6 is a perspective view of a trap similar to the embodiment of FIG. 2, but with a modified cover such as seen in FIG. 5 in a partially closed position; FIG. 7 is a perspective view of yet another embodiment of animal trap according to this invention incorporating a cover such as seen in FIG. 5, but replacing the angled barriers of the embodiment of FIG. 2 with a diverter or barrier extending upwardly from the floor toward the cover intermediate the entrance opening and the downwardly extending plate carried by the cover; FIG. 8 is a perspective view of the trap of FIG. 7 from another angle; FIG. 9 is a perspective view of an embodiment of animal trap according to this invention including an inclined plane trap assembly of the type seen in the '161 application in combination with a unique cover such as seen in FIG. 5 to minimize the possibility that a target animal will reverse itself before being electrocuted; and FIG. 10 is a perspective view of the trap of FIG. 9 from another angle. Like reference characters refer to like parts throughout the several views of the drawings. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS In describing preferred embodiments of the invention illustrated in the drawings, specific terminology will be resorted to for the sake of clarity. However, the invention is not intended to be limited to the specific terms so selected, and it is to be understood that each specific term includes all technical equivalents which operate in a similar manner to accomplish a similar purpose. A housing for the various trap embodiments of this invention is illustrated at 20 in FIG. 1 and can be formed of plastic, metal or other suitable material. The housing 20 includes a base 25 and a simple cover 30 hingedly secured thereto in a well known manner. The base 25 is divided longitudinally by a separator 35 to provide compartments on one side for reception of the electronic circuitry (not shown) at 40 and batteries (not shown) at 45 . The specifics of the electronic circuitry and energizing source are not critical to the instant inventive concepts and the '328 patent may be referred to for preferred embodiments which may be useful in the traps of this invention. However, it is to be understood that other circuitry may be substituted therefore without departing from the instant inventive concepts and, additionally, as an alternative to the use of batteries, appropriate means can be included to energize the trap from an a-c source or even an external d-c source. Additionally, as disclosed in the '328 patent, a pair of contacts (not shown) can be incorporated in the base 25 and cover 30 so that when the cover 30 is lifted to access the interior of the base 25 , the circuit is broken to preclude injury to the user. One form of two-diverter trap according to this invention is illustrated in FIGS. 2-4 and includes a pair of spaced charge plates or electrodes 50 , 52 located in the “killing” chamber 55 and electrically connected in a well-known manner to the electronic circuitry so that contact with both charge plates simultaneously by a target animal will actuate an electronic charge to effectively kill the animal. A principle feature of this embodiment of the instant invention is the mechanism by which an animal entering the trap is directed along a tortuous path or maze to make contact with the charge plates 50 , 52 . In this respect, a pathway is defined between the side wall 26 of the housing base 25 and the separator 35 from the trap opening entrance 60 to a bait receiving location 65 , with the charge plates 50 , 52 interposed in this path. Openings such as 26 ′ in the side wall, or elsewhere such as the openings 30 a ′ seen in the cover of FIGS. 5 and 6, may be provided to permit the odor of bait, if any, to exude to the atmosphere and attract the animal to the trap. In lieu of the tilting platform trapping mechanism of the '161 application, this embodiment of the instant invention substitutes at least two fixed barriers or diverter members 70 , 75 positioned between the opening 60 and the killing chamber 55 . The diverter 70 has one end 72 fixed to the side wall 26 of the base 25 , and extends at approximately a 45° angle toward the killing chamber, with the end 74 stopping short of the separator 35 to define a space “a” therebetween for passage of an animal. The second diverter 75 has one end 76 fixed to the separator 35 , and extends at approximately an oppositely directed 45° angle toward the killing chamber, with its second end 78 spaced from the side wall 26 by a distance “b”, again sufficient for an animal to pass through. Each of the diverters 70 , 75 extend upwardly at least substantially the full height of the side walls of the housing 25 so as to preclude an animal passing over the tops thereof when the cover 30 is closed. As will be seen best in FIG. 2, the end or edge portions 74 of the first diverter 70 and the end or edge portions 78 of the second diverter 75 overlap so that an animal entering the trap opening 60 does not have a clear view along the pathway, but must pass through a “maze” formed at “a” and “b” to reach the bait 65 . Since mice and other such small animals are curious and attracted to dark spaces, the pathway from the opening 60 will entice them into the trap housing, whether a bait is present or not. However, placement of a quantity of odoriferous material such as peanut butter at the end 65 of the pathway will further attract the animal into the killing chamber 55 . Once the animal passes the first diverter 70 on its way to the space “b”, it no longer has a clear view of the opening 60 behind it and is discouraged from reversing its direction. Thus, as the animal progresses along the pathway from the opening 60 , through the spaces “a” and “b” toward the bait-receiving area 65 , it will step onto the charge plates 50 , 52 , which are slightly spaced apart, but close enough that the animal must contact both plates simultaneously before reaching the bait at 65 . Upon doing so, the circuit will be closed by the animal's body and an electrical charge will kill the animal. The barrier 75 also acts as a blocking mechanism inhibiting the animal from retreating from contact with the charge plates 50 , 52 after the initial shock, insuring continued contact until the animal is electrocuted. The cover 30 can then be opened to break the circuit and dispose of the animal, following which the trap can be reused in an obvious manner. Although only two barriers or diverters are shown at 70 , 75 and for all practical purposes, this is sufficient to effect both the maze-like pathway and to protect against accidental contact with both of the charge plates 50 , 52 , from a straight element such as a screwdriver or the like (not shown), additional barriers can be included to render the path even more tortuous without diverging from the instant inventive concepts. Referring now to FIGS. 5 and 6, a modified trap incorporating a third barrier is illustrated. In this trap, parts similar to the embodiment of FIGS. 1-4 are designated by the same reference numeral followed by the suffix “a”. For all intents and purposes, the base 25 a of the trap 20 a is identical to the base 25 of the trap 20 . However, the cover 30 a of the trap 20 a differs from the cover 30 of the trap 20 in having affixed to the underside thereof a third diverter or barrier 80 which is positioned along the length of the cover 30 a to extend into the space between the electrodes 50 , 52 when the cover 30 a is pivoted to its closed position. The height “h” of the barrier 80 is less than the height “h′” of the side walls of the housing 25 a to provide a limited space between the lower edge 80 ′ of the barrier 80 and the floor of the base 25 a to force a target animal to squeeze under the barrier 80 as it moves toward the bait. Thus, at the time the animal's front paws engage the second electrode and energize the electrocuting circuit, its body is extended and contorted such that withdrawal from contact with the electrodes is rendered more difficult. Although the diverter 80 is preferably carried by an openable cover, it could be carried by a fixed cover if access to the chamber for disposing of the electrocuted carcasses is provided elsewhere, or, for that matter, it could be fixed to the sides of the pathway. While it is evident that a diverter such 80 is best used in conjunction with the angled diverters as shown in FIGS. 5 and 6, it has independent utility in minimizing escape from an electric or electronic trap of other constructions. See, for example, the discussion below of the embodiments of FIGS. 7 and 8 and FIGS. 9 and 10. The two-diverter trap shown in FIGS. 2-4 of the drawings was tested both with the diverters illustrated and without diverters. Additionally, traps containing a third diverter as seen in FIGS. 5 and 6 were tested. The tests were conducted on both male and female wild Mus Musclus, the house mouse, of varying size and age. Mice were collected from wild populations on farms and adjusted in the laboratory for two to three weeks before being used in the tests. Five field mice were placed in an arena measuring 4×8×3 ft (width by length by height). Within the arena, a shelter containing shredded paper towels was placed at one end. On the opposite end of the arena, a food (Purina lab chow) and water source were placed. The 5 mice were then allowed to acclimate for a period of 8 hours within this arena. During this period, the lights were left “on” to simulate daytime. At the end of this period, the corresponding test traps were placed into the arena for a period of approximately 16 hours. All traps were baited with creamy peanut butter (Shur-Fine brand). During this time, the lights were turned “off” to simulate nighttime. Five traps were placed in each arena with each arena considered a replication. Three arenas were used during each testing period. The traps were evaluated based on three criteria: (1) Kill rate (the number of mice killed divided by total number of traps); (2) Escape rate (where the mouse has triggered the trap but was not killed); and (3) Interaction (the total number visited by mice resulting in either a kill or escape). Sample t-tests were used to determine the significant differences between the traps with and without diverters (Windows 2000, Excel, Microsoft Corporation). Kill Rate: The traps with two and three diverters had mean kill rates of 83.4% and 100%, respectively, compared to 43.4% for traps without diverters. When analyzed using a t-test at 95% probability, the kill rate of the traps with two and three diverters was significantly greater than the traps with no diverters. (See Tables 1-3) Escape: The traps with two and three diverters had mean escape rates of 3.33% and 0%, respectively, compared to 53.33% for the trap without diverters. When analyzed using a t-test at 95% probability, the traps without diverters had a significantly higher escape rate compared to the traps with two and three diverters. (See Tables 1-3) Interaction: The traps with two and three diverters had mean interaction rates of 86.67% and 90%, respectively, compared to 96.67% for the trap without diverters. When analyzed using a t-test at 95% probability, the interaction was not significantly different. (See Tables 1-3) The traps were identical to each other with the exception of the two and three diverters, yet the trap with the diverters performed significantly better, killing more mice with fewer escapes without significantly reducing interaction. Although not wishing to be bound by an explanation of these results, there are two theories for why the diverters reduce the escape rate. First, as the mouse is moving through the trap without diverters, it moves slowly. When it touches the second plate and gets shocked, it is able to back off. In the trap with diverters, the second diverter acts as a barrier, preventing the mouse from retreating. In one instance, there was fur observed on one of the diverters of the trap that had an escape, indicating that the barrier did interfere with the retreat of the mouse. The second theory is based on the space in the trap. The diverters restrict the movement of the mouse until it gets close to the second plate and peanut butter. At this point, the trap opens up to the entire width of the tunnel. It is believed that the mouse is more tentative in the confined space in the diverter areas, but once it sees the open space and the peanut butter, it is more willing to commit. With more of the momentum of the mouse going forward, it is less likely for it to retreat once the shock is triggered. Finally, traps with three diverters had an even greater kill rate and lower escape rate. Results have shown in these tests that mice not only move back away from the electric plates after being shocked, but also move up. Traps with a third diverter prevent the mouse from jumping in this upward direction to escape. In fact, dead mice removed from these traps after being shocked have indentations on their back from hitting the third diverter. In conclusion, both traps with two and three diverters are significantly better in controlling mouse populations than traps without diverters. Mice have an instinctive behavior to avoid being shocked, however, this behavior can be predicted and prevented through the use of diverters in the trap design. Regardless of the theory, the results are self-evident from the data below: TABLE 1 Electronic Mouse Trap with Two Diverters Percent Kill # Mice Killed/Rep (5 mice per Rep) Total AVE % 1 2 3 4 5 6 Killed Per Rep SD Mortality 5 4 3 4 4 5 25 4.17 0.75 83.33 Percent Interaction # Mice Interacted/Rep (5 mice per Rep) Total AVE % 1 2 3 4 5 6 Interaction Per Rep SD Interaction 5 4 3 5 4 5 26 4.33 0.82 86.67 Percent Escape # Mice Escaped/Rep (5 mice per Rep) Total AVE % 1 2 3 4 5 6 Escapes Per Rep SD Escape 1 3 2 4 2 4 16 2.67 1.21 3.33 TABLE 2 Electronic Mouse Trap with Three Diverters Percent Kill # Mice Killed/Rep (5 mice per Rep) Total AVE % 1 2 3 4 Killed Per Rep SD Mortality 5  3* 5 5 15 5.00 0.00 100 Percent Interaction # Mice Interacted/Rep (5 mice per Rep) Total AVE % 1 2 3 4 Interaction Per Rep SD Interaction 5  3* 5 5 15 5.00 0.00 100 Percent Escape # Mice Escaped/Rep (5 mice per Rep) Total AVE % 1 2 3 4 Escapes Per Rep SD Escape 0 0 0 0 0 0.00 0.00 0 *Two mice escaped from test arena. TABLE 3 Electronic Mouse Trap without Diverters Percent Kill # Mice Killed/Rep (5 mice per Rep) Total AVE % 1 2 3 4 5 6 Killed Per Rep SD Mortality 4 2 3 0 3 1 13 2.17 1.47 43.33 Percent Interaction # Mice Interacted/Rep (5 mice per Rep) Total AVE % 1 2 3 4 5 6 Interaction Per Rep SD Interaction 5 5 5 4 5 5 29 4.38 0.41 96.67 Percent Escape # Mice Escaped/Rep (5 mice per Rep) Total AVE % 1 2 3 4 5 6 Escapes Per Rep SD Escape 1 3 2 4 2 4 16 2.67 1.21 53.33 Reference is now made to FIGS. 7 and 8, where yet another embodiment of the instant invention is illustrated, with parts similar to those of the previous embodiments being designated by the same reference numeral followed by the suffix “b”. Again, for all intents and purposes, the base 25 b of the trap 20 b is identical to the base 25 of the trap 20 or the base 25 a of the trap 20 a , with the exception that the angled diverters have been eliminated. In this embodiment, the cover 30 b is identical to the cover 30 a and includes a downwardly extending plate or barrier 80 b positioned along its length to fit in the space between the electrodes 50 B, 52 b when the cover 30 b is pivoted to its closed position. Additionally, the trap 20 b includes an upwardly extending plate or barrier 82 interposed between the entrance opening 60 b and the downwardly depending plate 80 b . The height of each of the plates 80 b , 82 is less than the height h′ of the side walls of the housing 25 b to provide a limited space over the upper edge 82 ′ of the plate 82 and under the lower edge 80 b ′ of the plate 80 b for the target animal to pass. According to a preferred feature of this invention, the upper edge 82 ′ of the plate 82 is spaced from the floor of the housing 25 b by a distance greater than the distance from the lower edge 80 b ′ of the plate 80 b whereby the plates 80 b , 82 together define a barrier blocking simultaneous access to the electrodes 50 b , 52 b from a straight element passing through the entrance opening 60 b. Thus, with this embodiment, the limited space between the downwardly depending plate 80 b and the floor of the housing 25 b forces the target animal to squeeze thereunder making it almost impossible for the animal to pull back once its front paws have contacted the second electrode 52 b . The upwardly extending plate 82 also functions to discourage a target animal from reversing its path because of the difficulty in squeezing back through the space between the upper edge 82 ′ of the plate. 82 and the undersurface of the cover 30 b. The embodiment of FIGS. 9 and 10 is included to illustrate that, even if an inclined plane or tilting platform assembly is incorporated in a trap according to the instant invention, the inclusion of a cover of the type seen in FIG. 5, including a downwardly extending plate which is positioned intermediate the electrode members when the cover is dosed, enhances the effectiveness of the trap by minimizing the likelihood that the target animal can back away from the second electrode before it is electrocuted. In this embodiment, parts similar to the previous embodiments are designated by the same reference numeral followed by the suffix “c”. For all intents and purposes, the trap, 20 c is very similar to the trap 20 a of FIGS. 5 and 6, with the exception that an inclined plane or tilting platform assembly 100 is incorporated adjacent the entrance opening 60 c . The manner in which the tilting platform or inclined plane assembly 100 operates is well known. Reference may be had to the '161 application for further details. As shown, the inclined plane trap assembly 100 includes a platform element 102 having a first end portion 104 juxtaposed to the entrance opening 60 c and a second end portion 106 juxtaposed to the second electrode 52 c . A pivot element (not shown) underlies and supports the platform element 102 intermediate its end portions 104 , 106 for tilting movement of the platform element 102 in a well known manner between a first position in which the first end portion 104 is lowered and the second end portion 106 is raised, and a second position in which the first end portion 104 is raised and the second end portion 106 is lowered. A door member 108 is hinged at its lower edge 108 ′ adjacent to the entrance opening 60 c for pivotal movement between a lowered position in which the door member 108 rests on the first end portion 104 of the platform element 102 when the platform element is in its first position to provide access to the passageway by a target animal through the entrance opening 60 c , and a raised position in which the door member 108 is lifted by upward movement of the first end portion 104 of the platform element 102 when the platform element 102 is moved from its first position to its second position. The door member 108 is biased toward its lowered position under the force of gravity, the weight of the door member 108 on the first end portion 104 of the platform element 102 when the door member 108 is in its lowered position normally maintaining the platform element 102 in its first position. However, the weight of a target animal on the second end portion 106 of the platform element 102 tilts the platform element 102 to its second position when the target animal passes from the entrance opening 60 c beyond the pivot element thereby lifting the door member 108 to its raised position, blocking escape through the entrance opening 60 c by a target animal on the platform element 102 . In the embodiment shown, the platform element 102 is connected to the circuitry (not shown) to electrify the same to function as a first electrode. An insulator 110 in the form of a plastic or rubber element underlies the second end portion 106 of the platform element 102 so that the target animal is only shocked when its rear paws are on the platform element 102 and its front paws are on the second electrode 52 c . In this embodiment, the platform element 102 , in either of its positions, blocks simultaneous contact with both of the electrodes by a straight element passing through the entrance opening 60 c. When the cover 30 c is closed, the downwardly depending plate 80 c is interposed between the end portion 106 of the platform element 102 and the second electrode 52 c , forcing 2 target animal to squeeze under the lower edge 80 c ′ of the plate 80 c in its attempt to get to the bait. In doing so, it must then step on the second electrode 52 c and, for all intents and purposes, is precluded from pulling back before the circuitry is closed by the animal's body and the animal is electrocuted. Thus, it will be seen that, even if a tilting platform or inclined plane trap is desired, the incorporation of the downwardly depending diverter or barrier plate carried by the trap housing cover as seen in the embodiment of FIGS. 9 and 10 adds further advantages in both minimizing the likelihood of escape by a target animal before electrocution and, additionally, by cooperating with the platform element to make it virtually impossible for a screwdriver or a child's finger inserted through the entrance opening 60 c to simultaneously contact both the platform element or first electrode 102 and the second electrode 52 c. In summary, in each of the embodiments of this invention, at least one diverter member is interposed in the pathway from the entrance opening along the interior of the housing to the second electrodes to discourage a target animal approaching the second electrode from reversing direction. Additionally, at least one barrier member is provided to block simultaneous contact with both of the electrodes by a straight element passing through the entrance opening. For the embodiments of FIGS. 2-8, there are literally no moving mechanical parts other than the cover so that the animal trap is inexpensive to manufacture, easy to maintain and highly effective in operation. Moreover, even with an inclined plane trap, the extra barrier plate enhances its effectiveness. The foregoing descriptions and drawings should be considered as illustrative only of the principles of the invention. As noted, the invention may be configured in a variety of shapes and sizes and is not limited by the dimensions of the preferred embodiment. Numerous applications of the present invention will readily occur to those skilled in the art. Therefore, it is not desired to limit the invention to the preferred embodiments or the exact construction and operation shown and described. Rather, all suitable modifications and equivalents may be resorted to, failing within the scope of the invention.

1a

RELATED APPLICATIONS [0001] This application claims priority to U.S. provisional application Ser. No. 60/846,677, Filed Sep. 22, 2006 BACKGROUND OF THE INVENTION [0002] The present invention relates to oxygen delivery for aircraft pilots and passengers, and is particularly applicable to supplemental oxygen requirements for general aviation. [0003] Pilots of general aviation aircraft are required to use supplemental oxygen when above 12,500 feet in altitude for greater than 30 minutes. When flying above 14,000 feet, pilots must use oxygen at all times. Passengers must have oxygen available at altitudes greater than 15,000 feet. Currently, this requirement is handled by aircraft carrying bottles of compressed oxygen or chemical oxygen generators when planning to operate in a regime requiring supplemental oxygen. Such bottles are heavy, and must be re-filled or replaced often when used with current supplemental oxygen systems. Other oxygen sources, such as oxygen concentrators, might be employed, but devices of this type suitable for small aircraft, would typically require a method of conserving oxygen used by passengers and pilots, to avoid the need for an inconveniently large and heavy high capacity concentrator. Use of a device called a conserver, which is placed in the product line between an oxygen source and a user, potentially could improve the situation for either oxygen bottles or a concentrator solution for supplemental oxygen. [0004] The conserver, many designs of which are known in the art, is depicted in a general sense in FIG. 1 . A conserver generally is placed between oxygen supply 1 and a user, who accesses the conserver through a breathing device such as a cannula. Many types of cannula are known in the art, and do not form part of the novelty of the invention. A breath sensor, 4 , typically consisting of a pressure transducer and detection circuit, senses a user's breath demand, and responds by delivering a volume of oxygen-rich gas (known as a bolus) to the user through a valve 3 . This bolus, which is significantly less than the total volume of a typical inhalation, is entrained in the breath's air intake, and mixes with the air, eventually reaching the lungs, esophagus, and respiratory cavities (nose and mouth). Approximately half of an inspiration enters the lungs, where oxygen is absorbed. Elevated oxygen concentrations in this volume result in greater transfer of the gas to the blood. Because the lungs can only make use of oxygen in the volume that reaches them, conserver designs try to ensure that the bolus is delivered during the portion of an inhalation that actually reaches the lungs, typically the first 50% of a breath. Thus quick delivery of the bolus allows smaller boluses to be delivered while still satisfying the user's need for oxygen. Thus, the conserver delivers an effective amount of oxygen in relatively small, short bursts, constituting a more efficient use of the oxygen supply, whether sourced from finite supplies such as bottles or, fixed rate supplies, such as small concentrators. Such conservers are described in co-pending U.S. application Ser. Nos. 10/192,194, 11/170,743, and 11/274,275, which are incorporated in their entirety by reference. Typically a conserver will also have programmable logic, 2, which allows for the valve timing, and thus bolus characteristics, to be adjusted by various inputs, such as required aggregate oxygen delivery rate for example. [0005] Although individual conservers of the type currently known could be used with oxygen supplies with finite capacities such as compressed oxygen cylinders, such conservers could not be plumbed together for use with oxygen concentrators or other rate-limited oxygen sources, because they do not effectively deliver oxygen using an oxygen source without a pressure regulator and similarly, do not have means to match their output to the rate of oxygen production of a concentrator. Known medical oxygen conservers would also not be well-suited to the general aviation requirements where oxygen demand is determined by altitude and not medical need. Thus, it is the object of this invention to provide a conserver which is usable in a general aviation environment and achieves the result of more efficient use of an oxygen supply while providing adequate supplemental oxygen for higher altitude aircraft operation from a rate limited oxygen source. SUMMARY OF THE INVENTION [0006] The invention is a multi-port oxygen conserver system for general aviation, including at least one oxygen source input, at least pilot oxygen output port and at least one passenger output port, wherein each port includes a breath pressure sensor and a gas control valve, and each system includes an ambient pressure input, which in some embodiments is connected to an integrated pressure sensor, or aircraft instrumentation and a CPU, adapted to acquire the breath pressure sensors' or the aircraft's altitude data and to independently control the valves' timing. In one embodiment, the system further includes at least one back-up oxygen source port, a pressure sensor adapted to read the source pressure and be read by the CPU and, a source control valve, controlled by the CPU adapted to select either the primary source or the back-up source. In a preferred embodiment, the conserver system includes a user input panel adapted to communicate with the CPU. [0007] In various embodiments, the controller inputs and operations include: 1. Individual pilot and passenger flow settings 2. Pilot only flow setting 3. Production capacity distribution: 4. Altitude adjusting flow setting: 5. Adaptive auto-pulse: 6. Pilot selective delivery BRIEF DESCRIPTION OF THE DRAWINGS [0014] The detailed description of how to make and use the invention will be facilitated by referring to the accompanying drawings. [0015] FIG. 1 depicts the general operation of a conserver. [0016] FIG. 2 depicts a multiport conserver according to the invention DETAILED DESCRIPTION OF THE INVENTION [0017] Referring to FIG. 2 , a conserver of the present invention is shown. The conserver receives pressurized oxygen-rich air from a supply 1 , which could either be a finite capacity supply such as compressed gas bottles, or a limited rate supply such as an oxygen concentrator or other oxygen generating system. Both supply types could be available either simultaneously or in rotation. By allowing dual source inputs to the conserver, the invention provides an automated means for backup oxygen based on flow demand from passengers or to automatically switch from a depleted or faulted primary oxygen source to a backup source without interrupting the delivery of oxygen to the pilot and passengers. A concentrator is the preferred approach of the inventors, as electrical power is typically available, and therefore a concentrator needs very little service compared to refilling gas bottles. The utilization of an oxygen conservation system in conjunction with an oxygen concentrator also removes time constraints from the flight duration that might otherwise be present using gas bottles or chemical oxygen generators. An exemplary suitable concentrator is described in referenced U.S. application Ser. No. 10/192,194. If needed, such a concentrator could be supplemented by gas bottles for circumstances where the rate required exceeds the capacity of the concentrator. In any case, the projected increase in time before re-fill for gas bottles, using the novel conserver, is a factor of six, so the invention provides significant improvement even for the case where bottles only are used. [0018] At least two independent ports are advantageous for most general aviation applications, as the pilot's needs are greater than passengers', both by law and for safety reasons. Thus the conserver will preferably have at least two distribution ports serviced by valves 3 . Each valve will preferably have an associated breath sensor 4 . In the example shown, four passenger ports and one pilot port are shown, each with its own valve and sensor. Also, by way of example, one controller (CPU) 2 is shown which controls valve timing for each valve independently and manages the oxygen supply and distribution for the whole plane. Of course, multiple controllers could also be employed. The control of the valve timing determines the bolus volume, and therefore gas usage rate for each port. The oxygen source pressure sensor 5 allows the source of oxygen to be monitored for safety purposes and also for the bolus delivery timing to be adjusted to maintain proper oxygen volume delivery even as the source pressure varies with altitude or as a finite oxygen source is depleted beyond the regulator's set-point. Rate limited oxygen concentrators generally produce oxygen based on a pressure ratio between a high pressure, PH, and a low pressure, PL where, the backpressure in the system changes with altitude, which would make current conserver technologies give unreliable bolus volume doses. The ambient pressure sensor 6 allows adjustment and response to the changing ambient pressure conditions without manual intervention by the flight crew. The ambient pressure sensor may also be used as a trigger for activating the oxygen supply when altitude is reached. Alternatively, ambient pressure could be acauired from the aircraft's instrumentation. A variety of user inputs or pre-programmed modes allow for significant flexibility in how gas is used by each passenger and pilot, thereby allowing for a variety of ways to reduce gas utilization while maintaining safety. The user interface panel (UIP) 7 enables the conserver to be adapted to suit the number of passengers in a plane and to adjust the amount of oxygen delivered to each patient independently. The UIP also functions to notify the flight crew of any errors or alarm conditions detected in the oxygen supply and delivery system. The backup oxygen input system 7 allows the conserver system and CPU to switch over to a backup supply in situations where the primary source is depleted or when the demanded delivery rate exceeds the capacity of the primary oxygen source. In cases of emergency or unexpected changes in altitude this backup system can ensure proper oxygen delivery without flight crew intervention. [0019] Various exemplary modes of operation include: [0000] 1. Individual pilot and passenger flow settings: a. Each distribution port on the conserver would enable users to select the appropriate flow setting for their physical condition and flying altitude 2. Pilot only flow setting: b. The pilot would select the amount of oxygen required based on flying altitude and physical condition. c. The conserver would then distribute the remaining oxygen to the passengers evenly based on total minute-volume delivery (assuming a fixed-rate oxygen generating system as the oxygen source). 3. Production capacity distribution: d. The conserver could deliver the entire production capacity of the supply to the passengers and pilot based solely on the number of active ports. This would ensure maximum delivery of oxygen up to the capacity of the source. e. Each position could have a simple ±switch that would refine the delivery amount at a given port to allow for some individualization of oxygen delivery. 4. Altitude adjusting flow setting: f. The conserver's ambient pressure sensor would adjust the dosage rate to the pilot based on the flying altitude. Dosing could commence at 12,500 feet during daytime hours and 5,000 feet during nighttime hours and proportionally increase with altitude to the maximum rate of delivery based on the oxygen source. g. The conserver could alternately have an altitude adjustment setting where the pilot would select the approximate flying altitude and the conserver would deliver a fixed amount based on that setting up to the maximum delivery rate of the oxygen source. 5. Adaptive auto-pulse: [0000] h. To ensure oxygen delivery to the pilot and passengers at all times, the oxygen ports could be equipped with adaptive auto-pulse (see references) to deliver the correct minute volume of oxygen in the absence of breath detection. 6. Pilot selective delivery: The oxygen conserver could alter the delivery of oxygen to maintain delivery to the pilot in preference over the passengers if the conserver's source pressure sensor detected a drop in the source pressure [0028] Other modes of operation may suggest themselves to one skilled in the art given the flexibility of the novel conserver. [0029] A visual confirmation that oxygen is being delivered such as an LED indicator is advantageous as well. [0030] Another embodiment of the distributed conserver design could include a number of satellite conservers in communication with a main control unit at the oxygen source. This concept is similar in principle to the communication concepts identified in referenced patent application Ser. No. 11/274,755 However, in an aircraft environment, each seat could have an integrated conserving device with a common supply. With a rate limited supply, each seat conserver would communicate via hardwire or RF communication to the source controller to balance the oxygen demand to the oxygen supply, in order to achieve modes of operation such as described above. In this embodiment, the source unit would provide the CPU functions described above.

1a

RELATED APPLICATION This application claims priority to prior U.S. Provisional Application Ser. No. 60/207,019 filed May 5, 2000, the entire contents of which are hereby incorporated by reference. TECHNICAL FIELD OF THE INVENTION The invention is in the field of starches and starch derivatives. More particularly, the invention relates to a cold-water soluble extruded hydroxyalkyl starch product, and to films, coatings, and other products composed therefrom. BACKGROUND OF THE INVENTION Food, pharmaceutical, and industrial films and coatings contain a polymeric base that often is supplemented with plasticizers, detacifiers, surfactants, and coloring agents. Typically used polymers include gums; cellulose derivatives or hydrolysis products; synthetic polymers such as polyvinyl alcohol, polyvinyl acetate, polyurethane, polystyrene or polyvinylpyrrolidone; gelatin; dextrins; modified cook-up-starches, and combinations of the foregoing. These polymers are often very expensive or difficult to use, or have reduced acceptance by certain segments of the consuming public. In recent years, greater emphasis has been placed on replacing all or part of these polymer systems with more economical consumer-friendly starch-based polymers. Many starch materials have been used to make a variety of films, foams, and other industrial and food products. However, despite the variety of starch materials available, known starches generally can be somewhat unsuitable for use in these applications. For instance, native starches have two key limitations when used in films and coatings. Films made from unmodified or “reduced viscosity” starches generally are brittle, weak, cloudy, and opaque, and cooking is generally required to hydrate the starch polymers, inasmuch as native starches typically are water insoluble at temperatures at or below room temperature (25° C.). The problems of brittleness, clouding and opacity can be mitigated somewhat with a low degree of hydroxyalkylation of amylose and/or amylopectin contained in the starch to form a hydroxyalkyl starch, but still the hydroxyalkyl starch will be cold-water insoluble. Thus, such starches are not useful where heating is not available. To overcome the problem of cold-water insolubility, the starch may be physically or chemically modified, or may be enzymatically treated. One approach known in the art is to modify the starch by using alkylene oxide reagents, such as propylene, oxide, ethylene oxide, and the like. This process generally requires the use of organic solvents, such as ethanol, which are undesired due to the additional processing costs associated with such solvents. The prior art also has taught to hydroxyalkylate the starch using an aqueous process. The hydroxyalkyl starch thus prepared is then cooked by drum-drying or spray-drying, and is ground to be marketed as a pre-gelled or “instant” starch. While such pre-gelled starches are suitable for some applications, such starches are difficult to disperse in water in low temperatures. Starches used in film and coating applications may contain intact starch granules, which can result in poor film clarity and increased film opacity. Particularly in the case of drum-dried starches, large lumps, sometimes referred to as “fish-eyes,” are often formed. Also, the viscosity of these starches often is high, thus limiting the level of solids, which can be dispersed in an aqueous system without resulting in mixing and handling problems. Moreover, while occasionally additives such as borax, boric acid, gum arabic, and sulfate salts are added to improve wettability or dispersability, these solutions are somewhat unsatisfactory because of the additional costs required for such additional ingredients. Attempts also have been made to formulate a pre-gelled, starch using an extruder. However, such attempts often have resulted in processing difficulties, particularly when modified starches are extruded under conditions of low moisture. For example, U.S. Pat. No. 5,849,233 discloses a method of extruding starch. This reference recognizes processing difficulties in extruding starches, and purports to teach that these difficulties can be overcome by employing as a feed starch a starch with a coarse particle size. However, the process requires additional drying and conditioning equipment, and can entail extra processing costs. Other efforts to extrude starch (e.g., as shown in International Publication WO 00/08945, U.S. Pat. No. 3,904,429 and Canadian patent, 1,286,533) have not provided a cold water soluble starch that is film-forming in aqueous solution. The invention seeks to address these shortcomings in the art. SUMMARY OF THE INVENTION Surprisingly, it has been found that hydroxyalkyl starches can satisfactorily be extruded without encountering the difficulties found in prior art processes or requiring the unusually coarse particle size required of the prior art. The extruded hydroxyalkyl starches prepared in accordance with the invention are cold-water soluble and film-forming in aqueous solution, and are useful in a number of applications. In accordance with the invention, a process for preparing a cold-water soluble starch is provided. The process comprises providing a hydroxyalkyl starch, generally in granular form, and applying a shearing force to the starch in the presence of moisture in an extruder. The conditions in the extruder are controlled in a manner not heretofore known to provide a starch product that surprisingly is soluble in water at 25° C. and that is film-forming in aqueous solution. Generally, an extruder having a barrel, a die, and at least one rotating shaft is provided. The barrel includes at least first and second zones, the first zone being upstream from the second zone. The zones are typically defined by plural heads in the extruder barrel. In extruding the starch, the total moisture in the extruder is kept below about 25%. The temperature in the first zone is maintained at a level insufficient to gelatinize the starch at the moisture content in the barrel, and the temperature in the second zone is maintained at a level that is sufficient to gelatinize the starch. Additionally, the rotational speed of the shaft is controlled to impart a specific mechanical energy to the starch that is sufficient to result in a soluble extruded starch product that is capable of extrusion through the die, i.e., that is not overly tacky or otherwise not susceptible to extrusion. The extruded starch then may be cut, dried, and ground. The cold-water soluble starch thus prepared will be particularly suitable for use in connection with films, coatings, and like applications. Moreover, the invention is applicable to hydroxyalkyl starches having a conventional particle size distribution, and there is no need to use feed starch having an unusually coarse particle size. DESCRIPTION OF THE DRAWINGS FIG. 1 is a differential scanning calorimetry thermogram of a cold-water soluble starch prepared in accordance with the invention. FIG. 2 is a rapid viscoanalyzer profile for a cold-water soluble starch prepared in accordance with the invention. FIG. 3 is a side view illustrating the screw configuration shown for the extruder used in Example 1. FIG. 4 is a side view illustrating the screw configuration shown for the extruder used in Example 2. FIG. 5 is a side view illustrating the screw configuration shown for the extruder used in Example 3. FIG. 6 is a side view illustrating the screw configuration shown for the extruder used in Example 4. FIG. 7 is a side view illustrating the screw configuration shown for the extruder used in Example 5. FIG. 8 is a representational view illustrating an extruder useful in conjunction with the invention. DESCRIPTION OF THE PREFERRED EMBODIMENT The starting feed starch used in connection with the invention is a hydroxyalkyl starch, which may be derived from any suitable plant source, such as corn, potato, wheat, rice, sago, tapioca, high amylose corn, waxy maize, sorghum, and so forth. The hydroxyalkyl starch may be obtained commercially, or a native starch may be hydroxylated in accordance with known methods, such as those described in Starch: Chemistry and Technology , Whistler, et al., ed. (1984), pp. 343-49. The hydroxyalkyl starch may be otherwise modified, before, after or during hydroxyalkylation, such as via acid hydrolysis, enzyme treatment, heat treatment, oxidation, cross-linking or the like. Preferably, the feed starch is an acid-thinned hydroxypropyl corn starch. Most preferably, the starch has a particle size distribution such that at least 90% by weight of the starch granules pass through an 80-mesh (180 micron) screen. Such starch is cold-water insoluble, and must be cooked to form a paste. The hydroxyalkyl starch should be derivatized with a substituent having from 2 to 6 carbon atoms, and the degree of substitution (DS) of the starch may be any value suitable to provide a film-forming starch. In accordance with the invention, the feed starch is subjected to a shearing force, moisture and heat sufficient to gelatinize all or substantially all of the granules of the feed starch. The shearing force is applied by introducing the feed starch into an extruder, which, in accordance with the invention, may be a single screw extruder or a twin screw extruder or other suitable extruder. As shown in FIG. 8 , the extruder 100 generally includes a barrel 10 and a die 11 (in practice the extruder may include many other components, such as preconditioners, steam or water jackets, and numerous other components as may be conventional or otherwise suitable for use in conjunction with the invention). The extruder barrel includes at least first and second zones 12 , 13 , which generally are defined by heads in the extruder. The direction of travel is illustrated by the arrow 14 in FIG. 8 . Commercially available extruders useful in conjunction with the invention include those available from Wenger, such as the Wenger TX57 and TX144 extruders. The moisture content in the extruder barrel should be sufficient to gelatinize the starch, taking into account the moisture present in the feed starch (typically 9% to 12% by starch weight). Preferably, the moisture content is less than about 25% by weight (based on the total weight of dry starch and water in the barrel); more preferably, the moisture content is below about 22.5%; even more preferably, the moisture content is below about 20%; and even more preferably, the moisture content is below about 17.5%. The moisture may be added in the extruder preconditioner via addition of steam or liquid water. The preconditioner cylinder may be equipped with an agitator, such as a single agitator, dual agitators, or dual agitators with different speeds. In operating the extruder, the temperature of the heads is such that the temperature in the first zone is not sufficient to gelatinize the starch, but the temperature in the second zone is sufficient to gelatinize the starch. The head temperature typically ranges from about 25° C. to 200° C. (it should be noted that the head temperature may be different from the actual temperature of the starch in the zone of the extruder). The extruder may have more than two zones; the invention may be performed in any such extruder so long as two zones meet the relationship heretofore described. More preferably, the temperature increases steadily in the extruder to thereby gradually cook the starch. The invention also contemplates controlling the shaft speed of the extruder. The shaft speed typically ranges from 125 to 450 rpm, thus resulting in a retention time of from about 25 to 250 seconds. More generally, the shaft speed must be such as to provide a sufficient mechanical energy input that is sufficient to result in a starch product that is soluble in water at 25° C. If the specific mechanical energy input is too low, then the starch will be insufficiently hydrolyzed, leading to a starch that is not soluble. If the specific mechanical energy input is too high, the starch may become overly tacky, thus leading to problems with extrusion. Typically, the specific mechanical energy input will range from about 60 to about 150 kW/ton, although this and the other foregoing parameters may vary depending upon the extruder type. The extruded starch product thus formed will be an extruded mass, often an extruded starch product, that may be cut, dried, and ground to have any desired particle size distribution. An optimum particle size range is between 40 to 140 mesh (100-400 microns), with fewer than 30% of the particles passing through a U.S. 200-mesh (75 microns) screen. When a product is made with such particle size distribution, the product will exhibit good wettability. The product may have a viscosity range, as measured by a Brookfield Viscometer, from 100 to 300 cp at 15% solids at room temperature. A typical RVA (Rapid Visco Analyzer) profile is shown in FIG. 2 . The extruded starch product will be substantially free of starch granules, by which it is contemplated that the starch will be at least 95% gelatinized; this may be determined by an inspection of birefringence under a microscope using polarized light. FIG. 1 illustrates a differential scanning calorimetry thermogram at 10° C./min. from 20° to 140° C. of a mixture of one embodiment of the starch product of the invention and excess water (starch:water=1:3). No endothermic peaks normally expected for starch gelatinization are exhibited, thus signifying that the starch product is already gelatinized. The starch product prepared in accordance with the invention also will be substantially completely cold-water soluble, i.e., soluble in water at 25° C. A method for determining solubility is described below. Other methods can be found in such publications as “Physical Properties of Extruded Wheat, Starch-Additive Mixtures,” Singh et al., Cereal Chemistry 75 (3):325-30 (1998). In accordance with a preferred method for determining cold-water solubility, 9.0 g (dry basis) product is dispersed in 291.0 g of distilled water. After stirring for 30 minutes at room temperature, two 50 ml aliquots of the mixture are transferred into two centrifuge tubes and centrifuged at 2,000 rpm in a suitable centrifuge, such as an IEC CL2 laptop centrifuge, for 10 minutes. Twenty ml of each supernatant are then transferred to pre-weighed PYREX evaporating dishes, and the dishes are then weighed. The dishes are then placed on a steam bath to be evaporated to dryness. Residues are then dried in an oven at 105° C. for at least two hours, and the dried samples with dishes are then cooled to room temperature in a desiccator for at least two hours. The dishes are then weighed and recorded as a dry sample weight. Solubility is calculated using the following formula: Solubility=[(dry sample weight-tare)×30000]/(9.00×supernatant weight) The product will be deemed cold-water soluble if the solubility is greater than 90%. A starch product prepared by the process of the invention may have a solubility greater than 99.0% by the method described. The product prepared in accordance with the invention has an excellent film-forming property, and is particularly useful in connection with coatings. Films and coatings made of the product are clear, transparent, flexible, and strong at room temperatures. While it is not intended to limit the invention to a particular theory of operation, it is believed that the disruption of the starch granules leaves few granules intact to defract and defuse light, and to thereby cause opaqueness. The high shear encountered in the extruder also may realign the starch polymers in directions favorable to film-forming. The starch product of the invention may be used in any application where a film, coating, barrier, or binding material is desired. The product also may be used in any application where filler, viscosity, solid, adhesive, or texture modification is needed, for example, in polishing/clear coat applications, oil/lipid barrier, adhesive, water or moisture or vapor barrier, oxygen barrier, or physical barrier, protective coating, encapsulation, fluidized bed purification, texture modification, flavor entrapment and preservation, flavor migration inhibition (especially from alcohol-based solvents), opaque maskings and coatings, imaging-forming films for printing, for example, edible inks, flavored coatings, colored coatings, free-standing films, tablet coatings, capsules, thickeners, materials for agglomeration, and the like. The product may be used in connection with food products, such as nut meats, ready-to-eat cereals, snack foods of many types, confections including soft-pan items, chocolate, marshmallows, pressed mints, chocolate pan pieces, and rolled pieces, molded chocolate bars, coffee beans, processed and unprocessed meats, and the like. The starch product also may be used in connection with industrial and consumer products, such as paper, corrugating board, cardboard boxes, detergents, cleaners, and the like, and in pharmaceutical applications such as tablets, tablet coatings, capsules, agglomeration ingredients, and so forth. The product may be used in connection with other ingredients, including surfactants, polymers, fillers, and other ingredients as may be desired in a given application. As surfactants it is contemplated that those such as mono- and di-glycerides, di-acetyl tartaric esters of fatty acids, propylene glycol mono- and di-esters of fatty acids, polysorbate 60, calcium or sodium stearoyl 2 lactylate, lactyl stearate, sodium stearoyl fumarate, succinylate mono-glycerides, ethoxylated mono- and di-glycerides, and the like may be used. In certain applications, the starch may be used in conjunction with other natural polymers such as gums, cellulose derivatives, starch derivatives, starch hydrolysis products, microorganism products, or with synthetic polymers, such as polyvinyl alcohol, polyvinylacetate, polyurethane, polystyrene, polyvinyl pyrrolidone, and the like. The product of the invention is particularly useful in connection with film-forming applications. In accordance with the invention, a film may be made by providing the starch of the invention, mixing the starch with sufficient water to solubilize the starch and, optionally but preferably including a plasticizer, such as glycerin, a polyethylene glycol, a propylene glycol, oleic acid, triacetin, or the like. The film thus prepared without any additive may have a tensile strength generally above 35 Mpa at 55-60% relative humidity and room temperature (as measured, for example, by an INSTRON apparatus equipped with a one-inch rubber-based grip). The product also may be used in connection with an instant tack coating formulation. Such formulation preferably comprises water in an amount ranging from about 25% to about 85% by weight; the starch in an amount ranging from about 10% to about 25% by weight, and optionally a surface gloss agent; the surface gloss agent may serve to some extent as a plasticizer. Suitable surface gloss agents include, for example, maltodextrins, such as MALTRIN® M180 sold by Grain Processing Corporation of Muscatine, Iowa. When used, the surface gloss agent preferably is used in an amount ranging from about 5% to 50% by weight. More generally, any amount of water suitable to hydrate the starch and any amount of surface gloss agent suitable to impart surface gloss may be employed with or without colorants, flavoring agents, additional plasticizers, and the like. The invention also encompasses a protective coating formulation, which generally comprises water, starch and a plasticizer and/or surfactant. Suitable plasticizers include glycerol and propylene glycol; one suitable surfactant is Polysorbate 80. These ingredients may be added in amounts suitable for their intended function. The following Examples are provided to illustrate the present invention, but should not be construed as limiting the invention in scope. Example 1 Cold Water Soluble Acid-Thinned Hydroxypropyl Starch An acid-thinned hydroxypropyl starch (B790 PURE-COTE® starch, available from Grain Processing Corporation, Muscatine, Iowa) having a moisture content of about 11% and having a particle size such that more than 90% by weight of the starch passed through a US 80-mesh screen was extruded on a Wenger TX144 Twin Screw Extruder according to the following conditions to give an expanded product. The expanded product was dried in a fluid bed dryer. The screw configuration of the extruder was as shown in FIG. 3 and was set such that the starch was cooked and sheared to an extent such that no significant amount of intact granules remained. The extrusion conditions were as follows. 1A 1B 1C 1D 1E 1F 1G Raw Material Information Substrate B790 B790 B790 B790 B790 B790 B790 Dry Recipe % moisture 11.6 11.6 11.6 11.6 11.3 11.3 11.3 Feed Starch Rate (lb/hr) 4200 4275 4300 4400 4400 4500 4500 Cylinder Information Steam Flow to Cylinder lb/hr 84 85 85 86 86 97 91 Water Flow to Cylinder lb/hr 107 107 109 108 110 113 115 Extrusion Information Extruder Shaft Speed rpm 360 360 360 360 360 360 360 Extruder Motor Load % 79 80 78 84 80 79 78 Steam Flow to Extruder lb/hr 0 0 0 0 0 0 0 Water Flow to Extruder lb/hr 105 106 109 109 111 115 113 1 st Head Temp 101° F. 144° F. 95° F. 127° F. 95° F. 110° F. 97° F. 2 nd Head Temp 195° F. 192° F. 192° F. 190° F. 190° F. 191° F. 190° F. 3 rd Head Temp 225° F. 225° F. 225° F. 225° F. 225° F. 225° F. 225° F. 4 th Head Temp 258° F. 266° F. 274° F. 273° F. 269° F. 264° F. 265° F. 5 th Head Temp 320° F. 287° F. 312° F. 313° F. 319° F. 372° F. 306° F. 6 th Head Temp 280° F. 240° F. 200° F. 160° F. 170° F. 255° F. 265° F. Specific Mechanical 100.0 106.2 103.4 100.7 102.0 99.3 98.2 Energy kW/ton Product Assay Moisture (%) 6.9 6.5 6.9 6.6 6.3 6.5 — Solubility (%) 99.9 100 100 100 100 100 100 For each of these examples, the extruder specific mechanical energy inputs was greater than 80 kW/ton. The SME, shaft speed, temperature profile, and moisture content were used to monitor and control the extrusion process. Example 2 Cold Water Soluble Acid-Thinned Hydroxypropyl Starch A hydroxypropyl starch (B760 PURE-COAT®, available from Grain Processing Corporation of Muscatine, Iowa) was extruded on a Wenger TX57 Twin Screw Extruder having the screw configuration shown in FIG. 4 and under the following conditions to yield an expanded product, which was dried in a moving grate dryer. The conditions were as follows. 2A 2B 2C 2D 2E 2F 2G Raw Material Information Substrate B760 B760 B760 B760 B760 B760 B760 Dry Recipe % moisture 10-11 10-11 10-11 10-11 10-11 10-11 10-11 Feed Starch Rate (lbs/hr) 350 350 250 270 290 310 330 Cylinder Information Steam Flow to Cylinder 12 12 12 12 12 12 12 lb/hr Water Flow to Cylinder 8 8 8 8 8 8 8 lb/hr Extrusion Information Extruder Shaft Speed rpm 350 350 250 270 290 310 330 Extruder Motor Load % 51 51 35 40 41 46 47 Steam Flow to Extruder 0 0 0 0 0 0 0 lb/hr Water Flow to Extruder 10 10 10 10 10 10 10 lb/hr 1 st Head Temp 98° F. 97° F. 96° F. 96° F. 95° F. 95° F. 97° F. 2 nd Head Temp 135° F. 136° F. 124° F. 125° F. 125° F. 126° F. 126° F. 3 rd Head Temp 144° F. 198° F. 129° F. 131° F. 132° F. 135° F. 136° F. 4 th Head Temp 179° F. 180° F. 176° F. 175° F. 175° F. 180° F. 180° F. 5 th Head Temp 292° F. 295° F. 231° F. 233° F. 233° F. 236° F. 239° F. Specific Mechanical 79 79 76 81 77 81 78 Energy kW/ton The starches produced were substantially completely soluble (over 99%). Example 3 The starch used in Example 1 was extruded on a Wenger TX57 Twin Screw Extruder according to the following conditions and with the screw configuration shown in FIG. 5 . Raw Material Information Substrate B790 Dry Recipe % moisture ~11% Dry Recipe Rate lb/hr 175 Feed Screw Speed rpm 15 Cylinder Information Cylinder Speed rpm 278 Steam Flow to Cylinder lb/hr 0 Water Flow to Cylinder lb/hr 0 Extrusion Information Extruder Shaft Speed rpm 398 Extruder Motor Load % 42 Steam Flow to Extruder lb/hr 0 Water Flow to Extruder lb/hr 11 Knife Speed rpm 459 No. of Knives 2 1 st Head Temp  77° F. 2 nd Head Temp  78° F. 3 rd Head Temp 108° F. 4 th Head Temp 133° F. 5 th Head Temp 270° F. 6 th Head Temp Die Hole Size & How many? 3 mm/15 Die Pressure psi 500 Vacuum on/off inches of vac? OFF Specific Mechanical Energy kW/ton 148 The expanded, friable product thus formed needed no drying. The product was ground on a Wiley Mill followed by an Alpine Mill to give a powder. The powder was mixed into water at room temperature. A paste was formed, thus evidencing the gelatinized nature of the product. The paste was drawn into a thin film using a Meyer Road and then left to dry overnight at 50% relative humidity and 72° F. to form a clear, transparent film. Example 4 Cold Water Soluble Hydroxypropyl Starch A cross-linked hydroxypropyl starch (B992 PURE-GEL®, available from Grain Processing Corporation of Muscatine, Iowa), and having a moisture content of about 11% was extruded on a Wenger TX52 Twin Screw Extruder according to the conditions provided below and using the screw configuration shown in FIG. 6 . 4A 4B 4C Raw Material Information Substrate B992 B992 B992 Dry Recipe % moisture ~11 ~11 ~11 Feed Screw Rate rpm 12 12 12 Cylinder Information Cylinder Speed rpm 110 110 110 Steam Flow to Cylinder lb/hr 0 0 0 Water Flow to Cylinder lb/hr 27.1 27.1 27.1 Extrusion Information Extruder Shaft Speed rpm 160 160 160 Extruder Motor Load % 29 28 17 Steam Flow to Extruder lb/hr 0 0 6.4 Water Flow to Extruder lb/hr 5.5 16.7 4.8 1 st Head Temp 2 nd Head Temp 32° C. 33° C. 42° C. 3 rd Head Temp 32° C. 33° C. 42° C. 4 th Head Temp 90° C. 90° C. 90° C. 5 th Head Temp 90° C. 90° C. 90° C. 6 th Head Temp 65° C. 65° C. 65° C. 7 th Head Temp 62° C. 57° C. 65° C. 8 th Head Temp 62° C. 57° C. 65° C. 9 th Head Temp 63° C. 63° C. 65° C. Die Pressure kPa 1720 70 2760 The extruded product, which was in the form of a condensed bead was dried on a moving grate dryer and then ground into a powder. Each powder was mixed into water at room temperature to give pastes at 12% solids (thus evidencing the gelatinized nature of the extruded product). The pastes were evaluated for gel strength and clarity. Gel strength was determined using a Texture Analyzer, Stevens LFRA Texture Analyzer TA 1000, 1 cm diameter probe after one day refrigeration at 40° F. Clarity was determined by observation on a scale of 0 to 9, 0 being opaque and 9 being clearest. The following results were obtained. Evaluation Water B992 Starch Test Temperature 4A 4B 4C (control) Gel Strength 30° C. 26 25 26 * 40° C. 24 49 51 * 50° C. 50 56 60 48 65° C. 49 60 62 103 Clarity 30° C. 1 1 1 * 40° C. 3 5 4 * 50° C. 7 7 6 0 65° C. 9 8 8 8 *The control, B992 Starch, was not amenable to testing at 30° C. and 40° C. Starch B992 was not amenable to testing at 30° and 40° because these temperatures were too low to allow this starch to gelatinize. Gel strength reflects the thickening power of a product when the product is mixed with water (generally, a higher gel strength is preferred in many applications). Example 5 Cold Water Soluble Hydroxyethyl Starch A hydroxyethyl starch (K95F COATMASTER® starch available from Grain Processing Corporation of Muscatine, Iowa) and having a moisture content of about 11% was extruded on a Wenger TX57 Twin Screw Extruder under the following conditions and having the screw configuration shown in FIG. 7 . Raw Material Information Substrate K95F Dry Recipe % moisture ~11% Dry Recipe Rate lb/hr 146 Feed Screw Speed rpm 8 Cylinder Information Cylinder Speed rpm 3498 Steam Flow to Cylinder lb/hr 0 Water Flow to Cylinder lb/hr 0 Extrusion Information Extruder Shaft Speed rpm 324 Extruder Motor Load % 32 Steam Flow to Extruder lb/hr 0 Water Flow to Extruder lb/hr 13 Knife Speed rpm 1087 No. of Knives 1 1 st Head Temp 85° F. 2 nd Head Temp 169° F. 3 rd Head Temp 175° F. 4 th Head Temp 203° F. 5 th Head Temp 245° F. 6 th Head Temp Die Hole Size & 3/36 How many? Die Pressure psi 200 Vacuum on/off inches of vac? OFF Specific Mechanical Energy kW/ton 110 The product was made into an aqueous paste containing 35% extrudate at room temperature (thus evidencing the gelatinized nature of the Product). The paste was tested in a Rapid Visco-Analyzer (Newport Scientific) by monitoring the rotational viscosity and was found to have a viscosity of 1800 cP at 50° C. compared to a baseline viscosity measurement of the raw starting material of about 100 cP, thus evidencing the gelatinized nature of the extruded product. Additionally, when the paste was tested in a Rapid Visco-Analyzer by monitoring the rotational viscosity during a controlled heating of the paste, the product exhibited no gelatinization peak. The starting material exhibited a crisp, characteristic peak at 70° C. Example 6 Tack Coating and Cooked Products The expanded starch from Example 1, 18 parts by weight, was blended with MALTRIN® M180 (a maltodextrin available from Grain Processing Corporation of Muscatine, Iowa), 9 parts by weight to form a dry blend. Water, 73 parts by weight, was added to a kettle and stirred with a powered mixer so as to create a vortex. The dry blend was slowly added to the vortex, and the contents were mixed for an additional 10 to 30 minutes to form an instant tack coating. The tack coating may be applied to a dry feed product substrate, such as a corn curl, pretzels, snack mix, or like item. The product may be applied by spraying or ladling at a level of from about 1% to about 15% weight gain, including moisture. Seasonings, including savory seasonings such as Cajun, barbeque, cheese, mustard, ranch, Creole, and the like, or sweet seasonings such as sugar and pareils, may be added, and may be applied in any suitable manner, such as by hand or using a seasoning applicator. The resulting coated product preferably is dried in an oven at a temperature ranging from 300° F. to 450° F. to a moisture content of from about 3% to 5%. Example 7 Oil-Based Instant Coating Soybean oil, 50 parts by weight, was added to a vessel equipped with good agitation. The cold water soluble starch from Example 1, 7 parts by weight, was added to the stirred oil and mixing was continued in order to achieve a smooth mixture. Water, 42 parts by weight, and lecithin, 1 part by weight, were added as an emulsifier and mixing was continued for 10 to 15 minutes in order to achieve a smooth mixture. The coated product may be applied to a food substrate as discussed in Example 6. Preferably, the coated product is dried in an oven at 300° F. to 350° F. with forced air to a moisture content of from 3% to 5% in the finished product. Example 8 Coated Peanut Products A dusting mixture was prepared by dry-blending together the product of Example 1, 50 parts by weight, and MALTRIN® M100 (a maltodextrin available from Grain Processing Corporation, Muscatine, Iowa), 50 parts by weight. Blanched, unroasted medium runner peanuts were placed in a 16″ ribbed candy pan rotating at 20 to 25 RPM. A 50% sucrose solution was poured into the pan in an amount effective to just wet the nuts to give about a 2% weight gain. The dusting mixture was then applied until the surfaces of the dusted nuts appeared dry, to thus give about a 5 to 6% weight gain. The dusted nuts were then tumbled an additional 2 to 3 minutes, during which time they wet back. An additional dusting with the dusting mixture was administered in order to achieve a dry appearance. The dry appearing, dusted nuts were then recoated with the sucrose solution, and the resulting rewetted nuts were dusted to dryness again with the dusting mixture. This alternating procedure of wetting with the sucrose solution followed by dusting to dryness with the dusting mixture was repeated until a final dry appearing dusted nut resulted having a 75 to 100% weight gain as compared to the starting peanuts. The coated nuts were roasted in an oven at 300° F. for 40 minutes with occasional stirring to assure uniformity of the roast. The roasted coated nuts were cooled to room temperature and placed back into the ribbed pan rotating at 20 to 25 rpm. Subsequently, the instant tack coating formulation from Example 6 was sprayed onto the roasted coated nuts to provide approximately 0.5% weight gain in a rotating pan in order to create a slight tackiness. McCormick Barbecue Seasoning F76161, 6% to 8% weight gain was added, and the coated nuts were tumbled until the seasoning was well distributed. The resulting coated product was dried in an oven to a moisture level of from 3% to 5%. Example 9 Trail Mix Coating and Product A mixture was prepared by dry-blending together sugar, 25 parts by weight, the product of Example 1, 15 parts by weight, MALTRIN QD® M500 (a maltodextrin available from Grain Processing Corporation, Muscatine, Iowa), 5 parts by weight, and lecithin, 0.2 parts by weight. Water, 54.8 parts by weight, was added to a kettle and stirred with a powered mixer so as to create a vortex. The dry blend was slowly added into the water at the top edge of the vortex, and the contexts were mixed for an additional 10 minutes to form an instant trail mix coating. The resulting coating was sprayed onto a commercially purchased trail mix, by a spray gun system in a tumbler at a level of 5% to 15% weight gain. The resulting coated trail mix was dried in an oven at 150° F. to a moisture content of 10 to 12%. Example 10 Tablet Coating A coating for a ⅜″ round lactose/micro-crystalline cellulose placebo tablet was made. The coating had the following composition. Formulation Ingredients Percentage by Weight Product from Example 1 12.0% Water 88.0% 100.0 To prepare the coating, the starch was mixed into water with good agitation. A Vector HiCoater HC 100 coating pan with 2 spraying guns was used to apply the coating onto the tablets to result in a 2% weight gain on the tablet. The coating pan was set at the following conditions. Inlet temperature 60-65° C. Exhaust temperature 38-42° C. Pan speed 8 RPM Process air flow 590 CFM Spray air volume 125 atomize/50 pattern PSI Spray rate 130-150 ml/min. A plasticizer, such as glycerin, polyethylene glycols (PEG), propylene glycol (PG), oleic acid, triacetin, and the like can be used to improve the physical and mechanical properties of starch. Surfactants such as di-glycerides, tartaric acid esters of fatty acids, propyleneglyco mono and diesters of fatty acids, polysorbate 60, calcium or sodium stearoyl-2-lactylate, lactylic stearate, sodium stearoyl fumarate, succinylated monoglyceride, ethoxylated mono and diglycerides, and the like optionally may be used to provide hydrophilicity. Likewise, polymers of gums, cellulose derivatives, starch derivatives or hydrolysis products, and microorganism products, synthetic polymers such as polyvinyl alcohol, polyvinyl acetate, polyurethane, polystyrene, and polyvinylpyrrolidone, and so forth can be used to improve the performance of the starch, for example, by increasing the flexibility and strength of the film coating. Example 11 Film Coating A coating for a ⅜″ round lactose/micro-crystalline cellulose placebo was made. The coating had the following composition. Formulation Percentage by Ingredients Weight Product of Example 1 5.0% Hydroxypropyl methyl cellulose 5.0% Propylene glycol 1.0% Polysorbate 80 0.5% PURE-DENT ® B815 corn starch NF* 0.5% Titanium Dioxide 2.0% Color 0.2% Water 85.8% 100.0 *Available from Grain Processing Corporation, Muscatine, Iowa. To prepare the coating, the starch was mixed into water with good agitation. A Vector HiCoater HC 100 coating pan with 2 spraying guns was used to apply the starch to tablets to result in a 3% weight gain on the tablets. The coating pan was set at the following conditions: Inlet temperature 65-70° C. Exhaust temperature 40-45° C. Pan speed 8 RPM Process air flow 575-595 CFM Spray air volume 125 atomize/50 pattern PSI Spray rate 170-180 ml/min. Example 12 The properties of the starch extrusion may be characterized in part by an Extruder Solubilization Point Value (ESPV), which may be calculated as follows. ESPV = 1.71 × 10 6 × ( M + M ws ) × D 4 ( T h - T l ) ⁢ ( M ⁡ ( Fws ⁢ ⁢ Cps + Fww ⁢ ⁢ Cpw ) + ⁢ Mws ⁢ ⁢ Cpw ) ⁢ ⁢ ( Ffww 5 × M × Afg ) wherein M = mass flow rate of starch through extruder (kg/s) Mws = flow rate of water through extruder (kg/s) D = diameter of extruder barrel (m) T h = highest head temperature in barrel (° C.) T l = lowest head temperature in barrel (° C.) Fws = weight fraction of starch in feed Fww = weight fraction of water in feed Ffww = weight fraction of water in the barrel Afg = grams of starch from viscosity test*(g) Cps = specific heat capacity of starch (J/kg) Cpw = specific heat capacity of water (4186 J/kg) *From the method disclosed in “The Estimation of Starch Paste Fluidities.” W. R. Fetzer and L. C. Kirst, J. Cereal Chem ., American Ass'n of Cereal Chemists, Vol. 36, No. 2 (U.S., March, 1959). Preferably, the ESPV is greater than or equal to 1.0. Following is a table of extrusion conditions and ESPVs for the extruded starch of Examples 1, 2 and 3. Inputs Ex. 3 Ex. 1A Ex. 1B Ex. 1C Ex. 1D Ex. 1E Ex. 1F Ex. 1G SME, 148 100 106.2 103.4 100.7 102 99.3 98.2 kW/ton M, lb/hr 175 4200 4275 4300 4400 4400 4500 4500 Mws, 11 296 298 303 303 307 325 319 lb/hr T h , deg F. 270 320 287 312 313 319 372 306 T l , deg F. 77 101 144 95 127 95 110 97 Fws 0.89 0.884 0.884 0.884 0.884 0.887 0.887 0.887 Fww 0.11 0.116 0.116 0.116 0.116 0.113 0.113 0.113 Ffww 0.163 0.174 0.174 0.174 0.173 0.171 0.173 0.172 Dia, mm 57 144 144 144 144 144 144 144 Afg 36 36 36 36 36 36 36 36 M/SME 1.18 42.00 40.25 41.59 43.69 43.14 45.32 45.62 ESPV 1.0 1.1 1.7 1.1 1.3 1.1 0.9 1.2 Inputs Ex. 2A Ex. 2B Ex. 2C Ex. 2D Ex. 2E Ex. 2F Ex. 2G SME, 79 79 76 81 77 81 78 kW/lb M, lbs/hr 350 350 250 270 290 310 330 Mws, 30 30 30 30 30 30 30 lbs/hr T h , deg F. 292 295 231 233 233 236 239 T l , deg F. 98 97 96 96 95 95 97 Fws 0.895 0.895 0.895 0.895 0.895 0.895 0.895 Fww 0.105 0.105 0.105 0.105 0.105 0.105 0.105 Ffww 0.176 0.176 0.201 0.195 0.189 0.184 0.180 Dia, mm 57 57 57 57 57 57 57 Afg 13 13 13 13 13 13 13 M/SME 4.43 4.43 3.29 3.33 3.77 3.83 4.23 ESPV 1.0 1.0 1.1 1.1 1.2 1.2 1.3 All of the ESPVs were above 1.0. Comparative Example Unacceptably sticky products were prepared by extruding B790 PURE-COTE® starch on a Wenger TX144 Twin Screw Extruder under the following conditions. Inputs C-1A C-1B C-1C C-1D C-1E SME, 86.9 76.4 103.6 140 150 kW/ton M, lbs/hr 3800 4100 4100 3000 3000 Mws, lbs/hr 380 370 382 238 300 T h , deg F. 269 269 269 293 305 T l , deg F. 97 87 90 96 86 Fws 0.88 0.884 0.884 0.88 0.884 Fww 0.12 0.116 0.116 0.12 0.166 Ffww 0.200 0.189 0.191 0.185 0.196 Dia, mm 144 144 144 144 144 Afg 36 36 36 36 36 M/SME 43.73 53.66 39.58 21.43 20.00 ESPV 0.8 0.9 0.9 1.3 0.8 As seen, all but one of the ESPVs were below 1.0 in these examples. It is believed that, although the barrel temperature was allowed to vary in accordance with the invention, the moisture content in the barrel was too high to result in an acceptable product given the other conditions. Thus, it is seen that the invention provides a satisfactory cold-water soluble starch. The starch may be prepared by extrusion in a conventional extruder. While particular embodiments of the invention have been shown, it will be understood that the invention is not limited thereto since modifications may be made by those skilled in the art, particularly in light of the foregoing teachings. It is, therefore, contemplated by the appended claims to cover any such modifications as incorporate those features, which constitute the essential features of these improvements within the true spirit and scope of the invention. All references cited herein are hereby incorporated by reference.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS The present application is a National Stage Application of International Application No. PCT/FR99/03293, filed Dec. 27, 1999. Further, the present application claims priority under 35 U.S.C. §119 of French Patent Application No. 98/16697 filed on Dec. 29, 1998. BACKGROUND OF THE INVENTION 1. Field of the Invention In certain corresponding structures currently available on the market, the game grid has the shape of a relatively flat parallelepiped. This grid consists of two parallel plane faces connected by walls that delineate the juxtaposed chutes. Both parallel plane faces comprise circular openings in order to is visualise the game pieces piled up in the chutes. This invention relates to the general domain of strategy games; and concerns in particular a strategy game for at least two players, utilizing game pieces, a game grid, and a plurality of juxtaposed vertical chutes in which the game pieces can be piled up in order to form rows and columns. 2. Discussion of Background Information In games of this type, the players take turn positioning a game piece in the vertical grid, with a view to form a row of a number of one's own pieces, horizontally, vertically or diagonally. The game grid is carried by an underframe that maintains the grid in a vertical plane. The juxtaposed chutes are open in the upper part to enable insertion of the game pieces; a removable bottom enables to keep the pieces and to dispose of them downwards once the game is completed. SUMMARY OF THE INVENTION This invention suggests to perfect the games that implement game pieces and a grid composed of a plurality of parallel chutes, in order to increase the strategic opportunities and consequently, to render the invention more attractive. According to this invention, the game comprises a mechanism for turning the game grid upside down so as to reverse the position of its top and bottom edges, and the grid comprises a mechanism enabling both ends of the juxtaposed chutes to be removably blocked. This structure enables the players to take turns inserting a game piece in the chutes of the reception grid, so as to try and form a predetermined geometric figure (straight line, cross; arrow . . . ), predefined using one's own pieces. During the game and according to a pre-set rule, the players may decide to turn the grid upside down in order to modify the positioning of the game pieces, according to one's own strategy or to disturb the opponent's strategy. To perform this operation, the upper end of the chutes is closed by the blocking mechanism provided on the corresponding edge of the game grid, the grid is turned upside down, then the blocking mechanism that formed the bottom of the chutes previously and are now located in the upper section, are deactivated, so that new game pieces can be inserted via the upper end of the chutes. The game grid can be mounted as fixed on its support frame; in which case, it is the frame/grid assembly that can be turned upside down, whereas the frame has an appropriate structure to ensure stable positioning of the grid, vertically, in one direction or the other. According to another possible embodiment, the game grid is articulated on its support frame about a horizontal axis so that it can be turned upside down by pivoting at 180°; the grid also comprises a mechanism for locking it in vertical position on the support frame. According to one aspect of the invention, there is provided a strategy game using at least two lots of game pieces with each lot being allocated to a player, the game comprising a game grid forming rows and columns, and having a juxtaposition of parallel chutes, the parallel chutes including a first end and a second end, at least one of the first and second ends being adapted to receive the game pieces, at least one of the first and second ends being adapted to be blocked so as to prevent the game pieces from falling out, the game grid being movable between at least a position wherein a first end is substantially disposed above the second end and at least a position wherein a second end is substantially disposed above the first end, wherein the game pieces are visible when disposed within the game grid. The game grid may comprise at least two ends which are adapted to receive the game pieces. The game grid may comprise at least two ends which are adapted to be blocked. Each of the first and second ends of parallel chutes may be adapted to receive the game pieces. Each of the first and second ends of the parallel chutes may be adapted to be blocked. The game grid is configureable so that the first end of parallel chutes receive the game pieces, while the second end of the parallel chutes is blocked. The game grid may be configureable so that the second end of parallel chutes receive the game pieces, while the first end of the parallel chutes is blocked. The game grid may be adapted to be arranged in a vertical or substantially vertical plane. The game may further comprise a frame for supporting the game grid. The game grid may be rotatably mounted to the frame. The game may further comprise at least one blocking mechanism for blocking one of the first and second ends in order to prevent the game pieces from falling out. The at least one blocking mechanism may comprise first and second blocking mechanisms for blocking the respective first and second ends. The at least one blocking mechanism may be movable between a blocking position which prevents the game pieces from falling out and an un-blocking position which allows the game pieces to fall out. The game grid may be one of pivotally and rotatably mounted on the frame about a horizontal axis. The game grid may be rotatable or pivotal by 180°. The game grid may be adapted to be locked in at least one position. The game grid may be adapted to be locked in two positions. The game may further comprise a mechanism for locking the game grid with respect to the frame. The frame may comprise two vertical stanchions and each stanchion may be arranged to be disposed along a side the game grid. The game may further comprise an articulation disposed between each stanchion and side of the game grid. Each side of the game grid may be pivotally mounted to a corresponding stanchion. At least one of the stanchions may comprise a mechanism adapted to cooperate with a mechanism disposed on the game grid, the mechanisms being adapted to lock the game grid in a vertical position. The mechanism disposed on the game grid may comprise at least one protruding toe. The mechanism disposed on the stanchion may comprise one of a snap-on system and a groove having contraction zones. Each side of the game grid may comprise at least one protruding toe. Each of the stanchions may comprise one of a snap-on system and a groove having contraction zones adapted to engage a corresponding protruding toe. The game may further comprise at least one blocking mechanism for blocking one of the first and second ends in order to prevent the game pieces from failing out, the at least one blocking mechanism being disposed adjacent an edge of the first or second ends. The blocking mechanism may comprise a retention element adapted to slide in an internal groove of the game grid. The retention element may comprise a control cursor which is adapted to be moved between at least a closed position and an opened position. The control cursor may be accessible by a player in order to move the retention element. The at least one blocking mechanism may be slidably disposed within the game grid and the at least one blocking mechanism may comprise at least one cursor, a plurality of openings, and a plurality of rungs. The at least one blocking mechanism may be slidably disposed within the game grid and the at least one blocking mechanism may comprise at least one cursor and a flexible rod. The game grid may further comprise at least one blocking mechanism and at least one protruding toe, and the toe may be movably connected to a cursor. The game may further comprise a frame with two vertical stanchions, wherein the game grid is configured such that movement of the cursor also controls movement of the at least one blocking mechanism, and such that the toe co-operates with a stop disposed on a vertical stanchion of a frame for locking the game grid in a vertical position. The invention also provides for a method of playing a game comprising at least two lots of game pieces, each lot being allocated to a player, a game grid forming rows and columns, and having a juxtaposition of parallel chutes, the parallel chutes having a first end and a second end, at least one of the first and second ends being adapted to receive the game pieces, at least one of the first and second ends being adapted to be blocked so as to prevent the game pieces from falling out, the game grid being movable between at least a position wherein a first end is substantially disposed above the second end and at least a position wherein a second end is substantially disposed above the first end, wherein the game pieces are visible when disposed within the game grid. The method comprises placing the game pieces in the game grid, moving the game grid to a first substantially vertical position wherein the first end is disposed above the second end, moving the game grid to a second substantially vertical position wherein the second end is disposed above the first end, and blocking at least one of the first and the second end. BRIEF DESCRIPTION OF THE DRAWINGS Other characteristics will appear in the light of the following description of various embodiments, given solely for exemplification purposes and represented on the appended drawings, in which: FIG. 1 is a front view of a first possible embodiment of the strategy game according to the invention; FIG. 2 shows the same game, seen in perspective, when turning the game grid upside down; FIG. 3 is a detailed view, in perspective, showing the upper end of the vertical stanchions that support the game grid, with the snap-on system that enables to lock the grid in vertical position; FIG. 4 is a cross sectional view along line 4 — 4 of FIG. 1, showing the removable blocking system at the end of the chutes, in active position; FIG. 5 is a cross sectional view along line 5 — 5 of FIG. 1, showing the removable blocking system at the end of the chutes, in inactive position; FIG. 6 is a cross sectional view along line 6 — 6 of FIG. 5; FIG. 7 is a perspective view of one of the game pieces; FIG. 8 is a cross sectional view along line 8 — 8 of FIG. 7; FIG. 9 is a cross sectional view along line 9 — 9 of FIG. 7; FIG. 10 is a partial perspective view that illustrates the assembly of the game grid on the vertical stanchions of the frame; FIG. 11 is a perspective view of an embodiment variation of the strategy according to this invention; FIG. 12 is an enlarged cross sectional view along line 12 — 12 of FIG. 11; FIG. 13 is a cross sectional view along line 13 — 13 of FIG. 11; FIG. 14 is a perspective view of the cursor and of a portion of the flexible blocking rod, provided as a single bloc; FIG. 15 is a front view of another embodiment variation of the strategy game according to this invention; and FIG. 16 is another front view of an embodiment variation of the strategy game according to this invention. DETAILED DESCRIPTION OF THE INVENTION As can be seen in the embodiment of FIGS. 1 and 2, the game according to this invention comprises a game grid 1 carried by a support frame 2 . The game grid 1 utilizes a juxtaposition of vertical chutes 3 in which game pieces 4 can be piled up so as to form rows and columns of pieces. In such a case, the game grid 1 utilizes seven chutes, whereas in each of them, seven game pieces can be piled up. A lot of game pieces is allocated to each player and the pieces of each lot can be differentiated for instance by their color. The different game pieces 4 piled up in the chutes 3 are visible via windows 5 provided on either side of the grid 1 . These windows have the shape of a star, but they can adopt any other shape, according to the overall aesthetic desired. The game grid 1 is generally square or rectangular in shape according to the number of chutes 3 and according to the height of the chutes; e.g., the game grip can comprise two lateral vertical sides and two horizontal end edges. The game grid 1 is articulated on the vertical stanchions 6 of the frame 2 about a rotation axis 8 so that the grid can be turned upside down. The rotation axis 8 is situated in the middle section of the grid 1 for easier pivoting. Both vertical stanchions 6 of the frame 2 extend in height slightly above the upper level of the game grid; at the lower section, they are interconnected by a linking structure 10 in the form of a footing. The game grid 1 comprises lateral toes 12 arranged on the cants of its lateral sides, that enable to lock it removably in vertical position, in connection with a snap-on system 14 provided on the stanchions 6 . The toes 12 look like protruding journals, four in number, provided at the ends of each lateral cant of the grid. A snap-on system 14 , detailed on FIG. 3, is provided in the upper section of each stanchion 6 ; this snap-on system has the shape of a groove 15 provided in the internal face of the stanchion 6 , fitted with a recess for central positioning 16 flanked, on either side, by two contraction zones 17 . The toes 12 located at the upper end edge of the game grid will nest slightly and forcibly into the central recess 16 of the lateral snap-on systems 14 , for stable positioning of the grid during the game. The grid can also be disengaged using a little strength so as to be turned upside down. Every snap-on system 14 is symmetrical on either side of the central recess 16 so that the locking and releasing operations can be performed on one side or the other, indifferently. The toes 12 situated at the lower edge of the game grid are used for locking this grid in the upper snap-on systems 14 , after pivoting at 180°. In the lower section of the internal face of the stanchions 6 , there are grooves 18 through which the lateral lugs 12 , located at the lower end edge of the game grid, pass unimpeded. The game grid 1 also comprises a mechanism for blocking or opening the ends of the chutes 3 , controlled in relation to the position of the chutes. The blocking position is used in the lower section of the grid, to form the bottom of the chutes; the opening position is used in the upper section of the grid to enable insertion of the game pieces in the chutes. These mechanisms, on each end edge of the game grid are detailed in FIGS. 4 to 6 . They utilize an internal groove 23 provided in the structure of the grid 1 parallel to its end edges, in which a retention element 24 is positioned. This retention element 24 has the general shape of a flat ladder whose width corresponds to that of the groove 23 , within the clearance, and whose length is smaller for easier sliding motion. The rungs 25 of the ladder 24 form blocking members separated by openings 26 . The number of rungs 25 corresponds to the number of chutes 3 and the retention element 24 may slide over half a chute's width, so as to adopt:—a closing position (FIG. 4) in which the blocking rungs 25 are placed in front of the end of the chutes 3 , and—an opening position (FIG. 5) in which the openings 26 are placed in front of the end of the chutes 3 , whereby the rungs 25 are laid on their side. The retention elements 24 are controlled using single-block lateral extensions 27 that extend on either side of the grid 1 through oblong slots 28 ; these lateral extensions 27 make up a control cursor. The game grid 1 utilizes two identical semi-shells, molded in plastic, whose internal faces are structured so as to form a portion of the parallel chutes 3 and a portion of the grooves 23 intended for positioning the retention elements 24 . Both these semi-shells are assembled together, after positioning the retention elements 24 in their reception groove 23 . On the embodiment illustrated on the drawings, the chutes 3 have an oblong cross section. The game pieces 4 , one of whose is detailed on FIGS. 7 to 9 , have a general shape and especially an adapted cross section. Preferably, the footing 10 and both lateral stanchions 6 are realised independent from one another by plastic moulding, then assembled using appropriate nesting structures. Still preferably, the game grid 1 is interconnected with the lateral stanchions 6 removably. As represented in FIG. 10, the axis portions 8 can be positioned in their support cradle 30 , after passing the end flange 31 through the circular opening 32 provided in the extension of the cradle. As illustrated in the figures, the footing 10 that links both vertical stanchions 6 may utilize a single plane plate. In an embodiment variation, the upper face of this plate may comprise recesses for accommodating game pieces; still according to another embodiment, this footing may provide a semi-cylinder arranged under the game grid 1 and whose opening is oriented upwards to form a chute for accommodating game pieces 4 . Before beginning the game, the grid 1 is locked vertically on its support frame 2 ; the blocking mechanism or system 23 , 24 of its lower edge is actuated so as to form the bottom of the chutes 3 . The blocking system 23 , 24 of its upper edge is deactivated to enable insertion of the game pieces 4 . The players take turns inserting a game piece 4 in the vertical chutes 3 , so as to try and form a predetermined geometric figure predefined, for example a straight line made of a certain number of pieces, e.g., a cross, a star, an arrow, etc. For increased attraction of the game, according to pre-set rules, the players may decide to turn the grid upside down in order to modify the respective positioning of the game pieces 4 , either according to their own strategies or to disturb the opponent's strategy, or both at the same time; the possibility of turning the grid upside down every round or every other round can be agreed in advance. To enable this pivoting, the blocking system 23 , 24 arranged at the upper end edge of the game grid is actuated; the grid is pivoted about its horizontal rotation axis 8 and, after having locked the lugs 12 in the snap-on system 14 , the blocking system 23 , 24 is deactivated and is now placed at the upper end edge of the grid that formed previously the bottom of the chutes 3 , with a view to enable new insertions of game pieces 4 . The game is ended when the predefined figure(s) has(have) been completed by one of the players or according to a predefined different rule. It should be noted that this game can be played by more than just two people, whereas the number of different game pieces will be suited consequently. In an embodiment variation, the blocking system 23 , 24 can be adapted so as to contribute to locking the grid 1 in a vertical position. To this end, one of the ends of the retention elements 24 may comprise an extension in the form of a toe going through an opening provided on the side of the game grid and capable of nesting into a recess provided opposite, in the internal face of the corresponding lateral stanchion, when the retention elements are controlled to open the upper end of the chutes 3 . Another embodiment of the strategy game according to this invention is illustrated in FIGS. 11 to 14 ; in these figures, the sections identical to the previous embodiment maintain the same reference numbers for easier understanding. In this variation, the removable blocking mechanism of the ends of the chutes 3 comprise flexible rods 35 that slide inside internal grooves 36 . A rod 35 is associated with each end edge of the game grid: the groove 36 that is guiding it, extends over practically the whole length of the corresponding end edge and practically over the whole length of one of the lateral sides of the grid. The length of the rods 35 corresponds approximately to the length of the end edge that it may block, and each rod 35 is controlled by a cursor 37 . The cursors 37 are arranged each on one of the lateral sides of the game grid; they extend on either side of the grid through longitudinal slots 38 . These longitudinal slots 38 are provided along the lateral sides of the game grid; their ends delineate the travel of the blocking rods 35 . Blocking one of the ends of the chutes, using one of the flexible rods 35 is made by causing the associated cursor 37 to slide towards the corresponding end edge of the game grid. The flexible rod 35 moves on one of the angles of this grid until it blocks the ends of all the juxtaposed chutes 3 . This active blocking position is visible on the lower edge of the game grid of FIG. 11 . Closing is made by a reverse motion, enabling the flexible rod 35 to be removed completely and to be placed parallel to the lateral side of the game grid. This deactivated position is visible on the upper edge of the game grid of the FIG. 11 . As can be seen on FIG. 14, the flexible rods 35 and the associated cursor 37 are made of single blocks, by plastic moulding. As with the previous embodiment, the game grid 1 utilizes two semi-shells assembled after positioning the flexible rods 35 and their cursor 37 . It can be seen in FIGS. 13 and 14 that the cursors 37 comprise two lateral wings 39 to maintain and guide the cursors 37 in appropriate grooves 40 provided along the longitudinal slots 38 (FIG. 13 ). For easier displacement of the flexible rods 35 on the corresponding angles of the game grid, the curving radius of the groove 36 at that level might be increased. In such a case, the locations of the game pieces located on the corresponding angles can be deleted. Using the game grid and/or turning the game grid upside down is identical to the procedures described in relation to the embodiment of FIGS. 1 to 10 . In the embodiment illustrated in FIG. 11, the game grid comprises eight juxtaposed chutes 3 in which eight game pieces can be piled up. For the reasons exposed above, certain angle locations could be deleted for easier travel of the blocking rods 35 ; preferably, in such a case, the four angle locations will be deleted so as to obtain a homogeneous game grid. In another embodiment illustrated in FIG. 15, the game grid 1 comprises triangular lateral extensions 42 that confer it an overall hexagonal shape. The articulation 8 of the grid 1 on the lateral stanchions 6 is made at the tip 43 of the extensions 42 , similarly to the nesting structure illustrated in FIG. 10 or a similar embodiment. The mechanism for blocking the grid in vertical position is similar to those of both previous embodiments, i.e., it utilizes toes 12 integral with the game grid, that can be nested into lateral snap-on systems 14 . In this embodiment, however, the toes 12 are placed on the sides of the 75 triangular extensions 42 and the lateral snap-on systems 14 are provided below the articulation axis 8 , on the edge of a structure 44 located in the alignment of the stanchions 6 or of the footing 10 . In a variation, the toes 12 can be deleted and the edge of the sides of the triangular extensions 42 can nest into a protruding snap-on structure on the extensions 44 . The removable blocking mechanism of the ends of the chutes 3 utilize two flexible rods 35 that are provided in sliding grooves 36 and that are associated with control cursors 37 , in a way similar to the embodiment of FIGS. 11 to 14 . Here, however, the flexible rods 35 follow the contour of the triangular extensions 42 so as to lengthen their possible travel. The principle of use of this embodiment is identical to that of the embodiment illustrated in FIGS. 11 to 14 . FIG. 16 illustrates a variation derived from the various previous embodiments. In this variation, the flexible rods 35 ′ that slide in the grooves 36 ′ look like flat ladders with rungs 46 making up retention elements, separated by openings 47 . Each of the rods 35 ′ is controlled by a cursor 48 provided on the side of the game grid. The cursors 48 extend on either side of the grid 1 and they are guided in oblong slots 48 ′ that delineate their travel. Given the particular ladder shape of the rods 35 ′, the travel of the cursors 48 is limited to half the width of a chute 3 . In FIG. 16, the flexible rod 35 ′ of the upper section of the grid is positioned so that game pieces 4 can be inserted in the grooves 3 and the rod 35 ′ of the lower section of the grid blocks the bottom of the chutes. The grid 1 can be locked in vertical position using toes 49 integral with the cursors 48 , that can be placed between sets of stops 50 provided on the internal face of the vertical stanchions 6 . When both sliding rods 35 ′ are in blocking position of the corresponding end of the chutes 3 , the game grid 1 can pivot freely about its articulation axis 8 . The grid can be locked in vertical position by one of the toes 49 , when the corresponding cursor 48 is controlled so as to open the upper end of the chutes.

1a

REFERENCE TO RELATED APPLICATIONS This application is related to provisional application Ser. No. 60/331,131 filed Nov. 9, 2001 entitled FLUIDIC SPA NOZZLE WITH MODE CHANGE DISC. BACKGROUND AND BRIEF DESCRIPTION OF THE INVENTION Fluidic and spa nozzles are widely known in the art. See for example the following patents: U.S. Pat. Nos. Inventor 3,471,091 Baker 4,151,955 Stouffer 4,227,550 Bauer 4,325,235 Bauer et al 4,407,032 Bauer et al 4,416,030 Reynoso 4,800,046 Malek et al 4,982,459 Henkin 4,985,943 Tobias et al 5,095,558 Howard 5,269,029 Spears et al 5,495,627 Leaverton 5,810,257 Ton 6,378,146 Johnston 6,401,273 Fung et al The present invention incorporates fluidic oscillators adaptable for submerged operation, e.g. for spa use, which can be caused to sweep or not sweep a jet of water with simple manual adjustment from the front of the device. In addition, the frequency of oscillation or sweeping of the water jet into the spa can be changed by adjusting the length and size of the inertance loop plates attached to the walls of the fluidic element itself. The inertance plates have inertance loop-forming grooves formed therein, one end of each inertance plate, forming a loop groove being juxtaposed over an aperture to a control passage and the other end of the loop groove being juxtaposed over a pass-through port or passage to the corresponding end of the loop on the loop groove in the opposing inertance plate to thereby form the frequency determining loop connecting the control ports of the fluidic oscillator. The invention also features a mode disc which is secured to the front of the fluidic in such a manner as to allow it to be manually rotated by a spa user to change the outlet geometry of the fluidic element and thus the character of the fluidic stream. In one position, the mode ring has a slot which aligns with and provides a continuation of the fluidic exit geometry and thus allows the water jet to oscillate. Upon rotation of 90°, for example, the slot is perpendicular to the fluidic exit geometry, and this results in the edges of the oscillating wave being backloaded so that the output is a straight focused jet. The shape of the rectangle can be made with the generally round section to control the feel of the jet in the jet mode. In addition, it can be adjusted to angles in between to achieve progressively narrower oscillations. The mode control disc has a pair of depressions or slots to each side of the slot in the mode disc to enable easy and firm grasping between the user's fingers. Air is routed through a central control valve. Air enters the rear of the spa nozzle housing and is kept separated from the water passages by O-rings. The air passes through two channels along either side of a water conditioning passage. The air goes to the top and bottom inertance plates of the fluidic oscillator. The inertance plates have an air channel in them to carry the air to an air entrainment hole or port downstream of the power nozzle. Thus, the object of the invention is to provide an improved fluidic spa nozzle. A further object of the invention is to provide an improved fluidic spa nozzle which incorporates a manually movable mode-change disc to control the sweeping of the jet back and forth in the spa. Another object of the invention is to provide an improved fluidic spa nozzle which incorporates inertance loop plates which are interconnected by a pass-through. Another object of the invention is to provide a structure which enables the air to be introduced into the spa nozzle just downstream of the power nozzle and to maintain the inertance loop substantially free of air and thus maintain the inertance loop operable. The inertance loop is comprised of a pair of plates secured to said top and bottom walls, respectively, each plate has a groove cut therein forming the inertance loop and having one end of said groove juxtaposed over an aperture in one of said control ports and the opposite end of said groove being juxtaposed over a passage passing between the top and bottom walls to interconnect with the end of a groove of opposing plates secured to the top and bottom walls. The spa tub nozzle includes a water ingestion port in the passage for purging air from said inertance loop. BRIEF DESCRIPTION OF THE DRAWINGS The above and other objects, advantages and features of the invention will become more apparent when considered with the following specification and attached drawings wherein: FIG. 1 is an exploded isometric view of a fluidic spa nozzle incorporating the invention, FIG. 2A is a sectional view of the assembled fluidic spa nozzle, and FIG. 2B is a sectional view taken on the plane of the device showing the fluidic silhouette, FIG. 3A is a front view of a schematic version of the device showing the mode disc, FIG. 3B is a schematic isometric view of the device showing the oscillating liquid jet, FIG. 3C is a schematic illustration showing the mode disc in a position to prevent sweeping, and FIG. 3D is a further isometric schematic view showing the straight flow. DETAILED DESCRIPTION OF THE INVENTION Referring now to the exploded view of FIG. 1 , the spa nozzle includes a main housing 10 which has an external threaded portion 11 for below the waterline securement or mounting by a gland nut (not shown) in the wall W of a spa, an air inlet barb 12 and a main water inlet barb 13 . The air inlet 12 is connected to a valve (not shown) for ON/OFF control. The upstream end 14 of subhousing 15 has a cutout 16 ( FIG. 2A ) that aligns with the flow inlet 13 to control water flow rate from full to about 30%. Subhousing 15 has a flared or bell-shaped section 15 B and an annular rib 15 R which engages the inner wall of main housing 10 . The downstream end of the subhousing 15 has a hook element CHM which will be described later in connection with the securement thereto of the escutcheon 40 . The fluidic oscillator element 20 includes an annular dam member 21 that receives an O-ring member 22 which engages the inner wall 23 of the upstream end 14 of subhousing 15 (see FIGS. 2 A and 2 B). This forms a water chamber WCP for feeding water into the fluidic itself. The fluidic oscillator per se is shown in silhouette form in FIG. 2 B and includes a plug P, a power nozzle PN for projecting a jet stream of water past a pair of control ports CP 1 , CP 2 through an interaction region IR which has sidewalls SW 1 and SW 2 which diverge or flare outwardly toward ambient and top TP and bottom BT walls. Top and bottom inertance plates 25 and 26 , respectively, are mounted on the top and bottom walls and have inertance loop forming grooves ILG (only one shown in FIG. 1 ) formed in the faces thereof. One inertance loop coupling aperture is shown in the view taken in FIG. 1 and designated as ILC for inertance loop connection passage to interconnect the control ports CP 1 and CP 2 . A similar passage or opening is formed in the opposite control passage CP 1 , but in the opposite sidewall thereof. (See exploded view shown in FIG. 1. ) The opposing ends of the inertance grooves and the inertance loops themselves are juxtaposed over a pass-through passage PTP so that the inertance loop extends between the two control ports CP 1 , CP 2 and controls the frequency of oscillation of the fluidic oscillator. Thus, the inertance loop between the two control ports CP 1 and CP 2 is comprised of inertance loop coupling passages ILC (one for each control port), two inertance loop grooves ILG (one in each of plates 25 and 26 ) which are connected by the passthrough passage PTP. The fluidic oscillator operates in a conventional fashion as follows: the water jet issues through power nozzle PN and passes across the control ports adjacent thereto and due to some perturbance, the jet will be closer to one or the other control port CP 1 or CP 2 . This produces a pressure gradient across the jet at the control ports to switch the let to one side or the other and then the process repeats. As noted earlier, the length and size of the inertance loop plates attached to the control ports of the fluidic element set the oscillating frequency. The frequency oscillation or sweeping of the water jet into the spa tub per se can be changed by adjusting the length and size (area) of the inertance loops formed on the inertance loop plates. An air passage or groove AG is formed in the top and bottom inertance plates for matching with other holes all in the body of the fluidic for air entrainment admission to air entrainment hole AH. In this embodiment the air entrainment hole AH is located downstream of the power nozzle PN. The fluidic interaction region IR has sidewalls SW 1 , SW 2 that diverge downstream of the power nozzle PN to form a “V” shape. To obtain sufficient air entrainment, the air entrainment hole must be located close to the power nozzle where the jet is still focused. If the air entrainment hole AH is moved further downstream, the moving (sweeping) jet is not over the hole for a sufficient period of time to allow sufficient air to be drawn in. When the air entrainment hole AH is positioned close to the power nozzle PN to optimize air entrainment, some quantity of air would be drawn into the inertance loop constituted by the groove AG in inertance plates 25 , 26 . Air is sufficiently less dense than water so its inclusion in the inertance loop would first raise the oscillating frequency, and then as more air contaminates the inertance loop, the oscillations would stop. To solve this problem, a water ingestion port WIP is added to the inertance loop. In addition to slowing the frequency (desirable in this application), the key benefit of the water ingestion port WIP is to provide water to purge the air contamination from the inertance loop. Without the water ingestion port WIP, the air entrainment hole AH would need to be placed further downstream and less air would be entrained into the exiting water (undesirable). Air entrainment may be enhanced by a slot structure SLO extending downstream of air entrainment port or hole AH, as is disclosed in Thurber et al application Ser. No. 09/899,547, filed Jul. 6, 2001, entitled SPA NOZZLES WITH AIR ENTRAINMENT, incorporated herein by reference. Integrally molded with the fluidic is an annular ring 29 which receives a rotatable or movable mode change disc 30 which has tabs 31 , 32 that are fitted into arcuate guide slots 33 , 34 . Mode change disc member 30 is also retained in position by a snap-on escutcheon member 40 . Snap-on escutcheon member 40 has a cooperating latch member CLM which engages a cooperating hook member CHM on the downstream end of housing 15 . Mode change disc 30 has an elongated slot 35 . The important feature about mode-change disc 30 is the slot 35 and its orientation relative to the downstream end of the interaction region or chamber IR. As illustrated, the mode disc 30 is generally round and has a generally rectangular slot 35 therein. The slots 33 , 34 and tabs 31 , 32 allows the mode disc 30 to be rotated up to about 90° to change the outlet geometry and thus the sweep of fluid stream. At 0° rotation (FIGS. 3 A- 3 B), the slot 35 is aligned with the diverging ends of the fluidic oscillator. As shown in FIG. 2B , the slot 35 is aligned with the width of the diverging end of sidewalls SW 1 and SW 2 of the interaction region IR, thus allowing the water jet to sweep. Thus at 0° rotation, the slot 34 provides a continuation of the exit geometry of the interaction region IR and allows the submerged jet to sweep or oscillate back and forth in the water of the spa tub. At 90° rotation, the slot 34 is perpendicular to the fluidic exit geometry. This results in the edges of the oscillating wave being backloaded, and the output is a straight focused jet. The rectangular slot 34 can be made larger with a generally round section to control the field of the straight jet in the jet mode. The disc 30 can be adjusted to angles from between 0° and 90° to achieve progressively narrower sweeping oscillations. The mode control disc 30 has a pair of side slots or depressions F 1 , F 2 to each side of the slot in the mode disc 30 to enable easy, ergonomic and firm grasping between the user's fingers. In the straight jet mode, the jet may have a pulsating sensation, depending on the size of the opening chosen. This pulsation feels twice as quick as the oscillations in oscillating mode due to the jet passing through the center twice per oscillation. In the straight jet mode, the water is concentrated in a smaller area than the oscillation mode. Therefore, the momentum flux and intensity, is greater. Control of the flow rates can be accomplished by rotating the sleeve valve formed in the subhousing and discussed briefly above. Air can be routed through the central control valve on the spa nozzle to a manifold, and an air line (not shown) from this manifold is connected to each spa nozzle housing via air barb fitting 12 . Air enters the rear of the housing and is separated from the water passages by the rear O-ring RO. The air passes through the two channels HC 1 and HC 2 on either side of the water chamber WCP. Air passages then turn 90° through aperture APP to the top and bottom inertance plates 25 , 26 of the fluidic, and each of the inertance plates 25 , 26 have an air channel AG in them to carry the air to the pass-through hole AH downstream of the power nozzle PN. The fluidic oscillator can be set in any angular position. As illustrated in the drawings, the fluidic oscillator is constrained in its fore and aft position by being retained between the housing and the escutcheon. It is constrained from rotating by the friction of the rear O-ring. While the invention has been described in relation to preferred embodiments of the invention, it will be appreciated that other embodiments, adaptations and modifications of the invention will be apparent to those skilled in the art.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS This application is based upon and claims the benefit of priority from Japanese Patent application No. 2004-174865 filed on Jun. 11, 2004, the entire contents of which is incorporated herein by reference. FIELD OF THE INVENTION The present invention concerns an inter-labial pad a portion of which is put between female labia and abutted to the labial inner surface in wearing and, more specially, it relates to an inter-labial pad capable of flexibly following-up the fluctuation of pressure caused from the right-to-left direction of a wearer in the state of wearing. RELATED ART Heretofore, sanitary napkins and tampons have been used generally as women's sanitary articles. For the sanitary napkins, a great effort has been made in order to prevent leakage of menstrual blood from a gap caused by poor adhesion to the vicinity of an introitus. Further, also for the tampons, since due to their attribution they cause foreign-body sensation, uncomfortable feeling upon wearing and difficulty in insertion to the inside of a vagina, various devices have been made in order to avoid them. Under the circumstances, sanitary articles referred to as inter-labial pads, which are of a hybrid type merging the features of the sanitary napkins and the tampons have become noted in recent years. The inter-labial pads are partially inserted between female labia and abutted against the inner surface of the labia in wearing. Accordingly, since the inter-labial pads have closer adhesion with a body compared with the sanitary napkins, leakage of the menstrual blood can be prevented and since they prevent the menstrual blood from diffusing and being in contact with a body at large area, they are sanitary and clean. Further, since the inter-labial pads are smaller in the size compared with the sanitary napkins, the inter-labial pads have a feature that they are excellent in the feeling of wearing and comfortable, and cause less psychological resistance compared with the tampons to be inserted inside of the vagina. As inter-labial pads having such features, those of various structures have been developed. For example, patent document 1 mentioned bellow discloses an inter-labial pad which is folded at a fold line along the longitudinal center axis of the inter-labial pad such that a pair of portions of a back surface are opposed to each other in which the pair of portions of the back surface are joined in at least one joined portion with each other. Further, as another example, commercial products having a liquid pervious surface side sheet, a liquid impervious back face sheet and an absorbent body interposed therebetween in which the back face sheet facing a garment is provided with a semi-circular gripping tag for attaching the inter-labial pad in an labia, and the tab is formed by embossing the back face sheet and the absorbent body simultaneously were sold trially in USA about from May, 2000 to May, 2001 (Envive: trade name of products, manufactured by Procter & Gamble Co.). [Patent Document 1] International Publication Application laid-open No WO 02/100315 pamphlet Any of the inter-labial pads in the prior art described above is in a substantially longitudinal shape having a longitudinal direction and a lateral direction and it is inserted being folded along the longitudinal center line. In this case, when a pressure caused from the right and left sides of the labia to the inter-labial pad fluctuates, since a gap is formed between the labial inner wall and the inter-labial pad, it may be a risk of leakage or a possibility that the inter-labial pad detaches from the labia. Particularly, in a moistened state where an absorbent body absorbs a body fluid, since fibers constituting the absorbent body are more tended to be slipped to each other, the inter-labial pad folded in two would not follow sufficiently to the fluctuation of the pressure in the right-to-left direction of a wearer in a state of wearing. On the other hand, in the absorbent body constituted with fibers capable of absorbing a body fluid, fibers can be oriented into a predetermined direction by a manufacturing method or a post treatment. However, in conventional inter-labial pads, no consideration has been taken on the relation between the direction of arrangement of fibers constituting the absorbent body and the following-up property of the inter-labial pad with respect to the fluctuation of the pressure in the right-to-left directions caused to the inter-labial pad. SUMMARY OF THE INVENTION The present invention has been achieved in view of the problems as described above and intends to provide an inter-labial pad capable of flexibly follow-up the fluctuation of the pressure in the right-to-left direction caused to the inter-labial pad in the state of wearing. More specifically, the invention provides an inter-labial pad comprising the following constitutions. (1) An inter-labial pad having an absorbent body capable of absorbing a body fluid and being put between labia in wearing, comprising; a pressure following-up recoverable structure having predetermined compressibility and bulk recoverability responding to an inter-labial pressure caused to the inter-labial pad from the right and left sides of the labia in a state of wearing, wherein the pressure following-up recoverable structure is formed by orienting at least a portion of fibers constituting the inter-labial pad so as to direct in the right-to-left direction of the labia. According to the inter-labial pad of the present invention, since it comprises a pressure following-up recoverable structure having predetermined compressibility and bulk recoverability responding to an inter-labial pressure caused to the inter-labial pad from the right and left sides of the labia in the state of wearing, it is properly compressed responding to pressurization caused to the inter-labial pad, and sufficiently recovers the bulk when the pressure caused to the inter-labial pad is released. Accordingly, no gap is formed between the labial inner wall and the inter-labial pad responding to the fluctuation of the pressure caused from the right-to-left directions, and can prevent the risk for the leakage of the menstrual blood and detachment of the inter-labial pad from labia. For example, in the absorbent body constituted with fibers capable of absorbing a body fluid, the fibers can be oriented to a predetermined direction by a manufacturing method or a post treatment. In a case where the direction of the fibers is aligned with respect to the longitudinal direction of the inter-labial pad, when a pressure is applied from the labial inner wall in the right-to-left direction in the state of wearing to the inter-labial pad, the fibers tend to intrude easily between other fibers. As a result, the inter-fiber distance is shortened and the thickness of the absorbent body is reduced to lower the bulk recoverability. Particularly, in a state of absorbing menstrual blood, since the fibers tend to slip more easily to each other, the fibers are more liable to intrude between other fibers to further lower the bulk recoverability. On the contrary, in the present invention, since the fiber orientation of at least a portion of the fibers constituting the inter-labial pad is aligned so as to be along the right-to-left direction which corresponds to the direction of fluctuation caused by the inter-labial pressure in the state of wearing, the inter-fiber distance is not shortened excessively due to the fiber rigidity responding to the fluctuation of the pressure caused from the right and left sides of the labial inner walls, between which the inter-labial pad is put and, even if it is shortened, since the recovering force due to the fiber rigidity exerts in a case where the inter-labial pressure is released, the thickness of the inter-labial pad tends to return easily to the original state. Accordingly, it can appropriately follow-up the fluctuation of the pressure in the right-to-left directions of the labial inner walls between which the pad is put, thereby capable of preventing the risk of leakage of the menstrual blood and detachment of the inter-labial pad from the labia. In the present invention, “orienting so as to direct in the right-to-left direction” means orienting to a direction which is parallel with the ground surface in the state of wearing the inter-labial pad and is vertical to pudential slit. Further, for the orientation of the fibers constituting the inter-labial pad, either the orientation of at least a portion of fibers may be aligned in the right-to-left directions, for example, in a case of using an embossing to be described later, or the orientation of the entire fibers is aligned in the right-to-left direction. The pressure following-up recoverable structure may be provided to the fiber aggregate constituting the inter-labial pad. Specifically, the pressure following-up recoverable structure may be provided to a surface side sheet, an absorbent body, a back face sheet having a fiber aggregate or other third member having a fiber aggregate alone or in a composite form thereof. The third member may be disposed on a surface of the surface side sheet, may be disposed between the surface side sheet and the absorbent body or between the absorbent body and the back face sheet in a case where it comprises a material having affinity with liquid, and it may be disposed either between the absorbent body and the back face sheet or may be disposed on the back face of the back face sheet in a case where it comprises a material not having affinity with liquid. Cases where the inter-labial pressure to the inter-labial pad increases in the state of wearing include, for example, a case where a wearer takes an attitude of sitting on a chair. Further, cases where the inter-labial pressure to the inter-labial pad is released include, for example, a case where a wearer takes an attitude of standing up from the chair. The compressibility means a property of decreasing the thickness of the inter-labial pad when the inter-labial pad is pressed at a predetermined pressure and for a predetermined time in the present specification. Further, the bulk recoverability means a property of increasing the thickness of the inter-labial pad when it is left with no pressure for a predetermined time after it has been pressed at a predetermined pressure and for a predetermined time. The necessary constitution for the inter-labial pad is to have at least an absorbent body constituted with fibers capable of absorbing the menstrual blood, and it is not particularly limited. For example, it includes a constitution of consisting only of the absorbent body or a constitution of consisting of the absorbing covered with a liquid pervious sheet, a constitution of forming a laminate comprising a surface side sheet/an absorbent body/a back face sheet shaped into a loop and, a constitution of folding a laminate comprising a surface side sheet/an absorbent body/a back face sheet folded along a crease as will be described later. (2) The inter-labial pad according to (1), wherein the absorbent body comprised absorbing fibers capable of absorbing the body fluid, and the pressure following-up recoverable structure is formed by orienting at least a portion of the absorbing fibers constituting the absorbent body so as to direct in the right-to-left direction. According to this embodiment, since the fibers (absorbing fibers) constituting the absorbent body capable of absorbing the body fluid are oriented to a predetermined direction by a manufacturing method or a post treatment thereof, this embodiment is particularly suitable to the present invention. As a method of orienting the absorbing fibers constituting the absorbent body in the direction of the thickness of the laminate, fiber orientation may be applied during sheeting of the absorbent body, or a post treatment such as enforcing the fiber orientation after the sheeting may be applied. (3) The inter-labial pad according to (1) or (2), wherein the inter-labial pad comprises a laminate having a surface side sheet in contact with the labia in the state of wearing, a back face sheet disposed so as to stack over the surface side sheet and not in contact with the labia, and the absorbent body disposed between the surface side sheet and the back face sheet, in which the inter-labial pad is of a substantially longitudinal shape having a longitudinal direction and a lateral direction, and is folded such that a pair of portions of the back face sheet are opposed to each other along a longitudinal crease of the laminate in wearing, and at least a portion of the inter-labial pad put between the labia has the pressure following-up recoverable structure. According to this embodiment, occurrence of the gap can be prevented easily by merely folding in two and, further, the gap can be prevented more easily by applying the pressure following-up recoverable structure. The gap can be prevented easily as described above by merely folding because the absorbent body extending from the crease as an axis to both the right-to-left directions is disposed corresponding to the labial inner wall extending from the vestibular floor as an axis to both the right-to-left direction so that the inter-labial pad can easily follow up the change of behavior of the labia. For example, in a case where the labia opens such that the right and left labial inner walls recede with the vestibular floor as an axis, also the right and left parts of the absorbent body can open following up the same with the crease as the axis. Then, in the present invention, since the pressure following-up recoverable structure is also applied in addition to the constitution described above, risk of the body flood leakage or detachment of the inter-labial pad from the labia can be prevented more reliably. (4) The inter-labial pad according to (3), wherein the pressure following-up recoverable structure is disposed symmetrically with the crease of the laminate as an axis of symmetry. According to this embodiment, the inter-labial pad compresses and the bulk recover uniformly to both right and left side of the labial inner walls without slanting either side. Therefore, the occurrence of a gap between only one side of the labial inner wall and the inter-labial pad can be prevented. (5) The inter-labial pad according to (3) or (4), wherein the pressure following-up recoverable structure is formed by orientating the absorbing fibers constituting the absorbent body in the direction of the thickness of the laminate. According to this embodiment, by orienting the fibers constituting the absorbent body in the direction of the thickness of the laminate, the direction of fibers constituting the absorbent body can be aligned to be along the right-to-left direction in which the inter-labial pressure is caused in the inter-labial pad in the state of wearing when it is folded in two. Accordingly, the inter-labial pad can properly follow-up the fluctuation of the inter-labial pressure and it is possible to prevent the risk of leakage of the menstrual blood and detachment of the inter-labial pad from the labia. Further, as a method of orienting the fibers constituting the absorbent body to the direction of the thickness of the laminate, for example, a treatment of enforcing the fiber orientation may be applied during sheeting of the absorbent body, or a post treatment of enforcing the fiber orientation may be applied after sheeting. (6) The inter-labial pad according to (5), wherein the absorbing fibers are oriented by applying concave/convex fabrication to the absorbent body. According to the embodiment, since the fibers can be compulsorily aligned to a predetermined direction by the concave/convex pattern, the absorbing fibers constituting the absorbent body can be oriented in the direction of the thickness of the absorbent body in the same manner as in (5) described above. (7) The inter-labial pad according to any one of (1) to (6), wherein the absorbing fibers constituting the absorbent body are crimped fibers. According to this embodiment, since the crimped fibers tend to cause partial fiber orientation and are excellent in the recoverability in a case where they are compressed so as to shrink, the bulk recoverability is enhanced and, accordingly, it is suitably usable particularly to the present invention. (8) The inter-labial pad according to any one of (1) to (7), wherein at least a portion of the absorbing fibers constituting the absorbent body is synthetic fibers. According to this embodiment, since the synthetic fibers are poor in the water absorbability, the fiber rigidity can be retained easily also in a case of absorbing the menstrual blood in a state of wearing the inter-labial pad. Accordingly, the compressibility and the bulk recoverability can be maintained during wearing. (9) The inter-labial pad according to any one of (1) to (8) wherein an elastic sheet is disposed to a portion of the inter-labial pad to be put between the labia. According to this embodiment, since the elastic sheet having a high bulk recoverability is provided, even when the inter-labial pressure fluctuates excessively, for example, by playing sports, a gap is less caused between the inter-labial inner wall and the inter-labial pad. (10) The inter-labial pad according to any one of (1) to (9), wherein the predetermined compressibility and the bulk recoverability are formed such that they are higher in the forward portion of the inter-labial pad situating at the front of a wearer compared with those in the backward portion of the inter-labial pad situated at the back of the wearer in the state of wearing the inter-labial pad. According to the embodiment, the compressibility and the bulk recoverability are made higher in the forward portion of the inter-labial pad situated at the front of the wearer compared with those of the backward portion situated at the back of the wearer. In this regard, since the forward portion of the labia minus pudendi is thicker and longer than the backward portion thereof with respect to the shape, the inter-labia pressure is higher and the fluctuation of the inter-labia pressure is larger in the forward portion. Accordingly, the following-up property of the inter-labia pad to the fluctuation of the inter-labial pressure can be improved further by controlling the compressibility and the bulk recoverability higher in the forward portion than in the backward portion of the inter-labial pad. (11) The inter-labial pad according to (10), wherein the inter-labial pad is applied with slitting from the forward portion to the backward portion. According to this embodiment, the higher inter-labia pressure in the forward portion and the lower inter-labial pressure in the backward portion can be separated by applying slitting to the inter-labial pad. This can prevent a high inter-labial pressure from being exerted particularly on the backward portion of the inter-labial pad. (12) The inter-labial pad according to any one of (1) to (11), wherein the predetermined compressibility and bulk recoverability are the compressibility and the bulk recoverability in a moistened state of absorbing the body fluid. Generally, the compressibility and the bulk recoverability of fibers are remarkably lowered in the absorbent body, particularly, in a moistened state. However, according to this embodiment, since preferred compressibility and bulk recoverability are provided in the moistened state of absorbing the body fluid, this can effectively prevent the risk of the leakage of the menstrual blood, etc. and the detachment of the inter-labial fluid from the labia. (13) The inter-labial pad according to any one of (1) to (12), wherein the predetermined compressibility and bulk recoverability of the inter-labial pad after it has absorbed an artificial body fluid about seven time as much as the mass of the absorbent body provide (a) a compression ratio in which the thickness of the inter-labial pad after it has been pressed at a pressure of 50 g/cm 2 for 3 min is 30% or more relative to the thickness of the inter-labial pad before it absorbs the artificial body fluid, and (b) a bulk recovery ratio in which the thickness of the inter-labial pad after it has been pressed at the pressure of 50 g/cm 2 for 3 min, and, further, left under no pressure for 2 min is 60% or more relative to the thickness of the inter-labial pad before it absorbs of the artificial body fluid. According to this embodiment, since the compression ratio in the state of absorbing the artificial body fluid by the method described above is 30% or more, even in a state where the inter-labial pressure is exerted on the inter-labial pad, the pad can easily deform under compression confirming the change of the shape of the labia and the inter-labial pad can follow-up the change. Further, since the bulk recovery ratio in the state of absorbing the artificial body fluid is 60% or more, even in a state where the inter-labial pressure lowers, the inter-labial pad follows-up the labial inner wall under bulk recovery. The thickness of the inter-labial pad in the present invention is a thickness assuming the state of wearing the inter-labial pad and, in the state of use where the laminate is folded in two, it means the total thickness in the folded state. (14) The inter-labial pad according to (13), wherein the compression ratio is 30% or more and 80% or less, and the bulk recovery ratio is 60% or more and 150% or less. According to this embodiment, since the compression ratio in the state of absorbing the artificial body fluid by the method described above is 80% or less, it is possible to prevent discharge of the body fluid once absorbed under excess compression. Further, since the bulk recovery ratio is 150% or less, it is possible to prevent excess urging of the labial inner wall. Particularly, in a case where the bulk recovery ratio is within a range from 100 to 150%, this means the volume increases to more than the volume before absorption of the artificial body fluid and, since this can reduce the volume upon insertion of the inter-labial pad, a wearer can easily insert the inter-labial pad in a narrow gap between labia and can easily attach the pad to a position reliably. (15) The inter-labial pad according to any one of (1) to (12), wherein the thickness of the inter-labial pad before it absorbs the artificial body fluid is from 3 mm to 10 mm, and the thickness of the inter-labial pad after it has been pressed at a pressure of 50 g/cm 2 for 3 min and further left under pressure for 2 min in a state where the inter-labial pad absorbs the artificial body fluid about seven times as much as the mass of the absorbent body. According to this embodiment, since the thickness of the inter-labial pad after releasing the pressurization in a state of absorbing the artificial body fluid is 3.8 mm or more, even in a state where the inter-labial pressure lowers, the pad can follow-up without causing a gap between the labial inner wall and the inter-labial pad. Further, since this is 15 mm or less, it can prevent excess urging on the labial inner wall. This invention can provide an inter-labial pad capable of flexibly following-up the pressure fluctuation in a case where an inter-labial pressure in the right-to-left direction of a wearer exerts on the inter-labial pad, for example, as in the attitude where a wearer is sitting on a chair, standing up from the chair or during vigorous movement and can provide an inter-labial pad of less leaking the menstrual blood from the inter-labial pad and less detaching the inter-labial pad from the labia. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view showing the state of wearing an inter-labial pad according to a first embodiment of the invention; FIG. 2 is a schematics view of an apparatus for fiber opening and laminating fibers for manufacturing an inter-labial pad according to the first embodiment of the invention; FIG. 3 is an enlarge perspective view showing an example for a portion of a lamination device in FIG. 2 ; FIG. 4 is an enlarge perspective view showing another example for a portion of a lamination device in FIG. 2 ; FIG. 5 is a perspective view showing the state of wearing an inter-labial pad according to a second embodiment of the invention; FIG. 6 is a perspective view of a laminating device for manufacturing an inter-labial pad according to the second embodiment of the invention; FIG. 7 is a perspective view showing the state of wearing an inter-labial pad according to a third embodiment of the invention; FIG. 8 is a perspective view of a laminating device for manufacturing an inter-labial pad according to the third embodiment of the invention; FIG. 9 is a perspective view showing the state of wearing an inter-labial pad according to a fourth embodiment of the invention; FIG. 10 is a cross sectional view of an inter-labial pad according to a fifth embodiment of the invention; FIG. 11 is a perspective view showing the state of wearing the inter-labial pad according to the fifth embodiment of the invention; FIG. 12 is a cross sectional view taken along line X 1 -X 2 in FIG. 11 ; FIG. 13 is a cross sectional view taken along line Y 1 -Y 2 in FIG. 11 ; and FIG. 14 is an upper view showing a modified example of the inter-labial pad according to the fifth embodiment of the invention. “DESCRIPTION OF THE SYMBOLS” 10, 10a, 10b inter-labia 100, 300, 400, 500, 600 inter-labial pad 110, 310, 410, 510, 610 absorbent body 311, 411, 511 crease 415 convex portion 416 concave portion 512 embossing 620 surface side sheet 630 back face sheet 650 elastic sheet 660a, 660b, 660c slit DESCRIPTION OF THE PREFERRED EMBODIMENTS Preferred embodiments of the present invention is to be described with reference to the drawings. In the subsequent descriptions for the embodiments, identical constituent factors carry identical reference numerals for which descriptions will be omitted or simplified. First Embodiment <State of Using Inter-Labial Pad> FIG. 1 shows a state of using an inter-labial pad 100 according to a first embodiment of the present invention. As shown in FIG. 1 , the inter-labial pad 100 has a substantially rectangular shape as a whole and is attached to labia so as to be put between wearer's labia 10 a and 10 b . The inter-labial pad 100 comprises a substantially rectangular absorbent body 110 . The absorbent body 110 is constituted with fibers capable of absorbing menstrual blood and the direction of the fibers are aligned, in a state of wearing, along the direction 10 a to 10 b in which the inter-labial pressure is caused, that is, in the direction of an arrow in FIG. 1 . <Manufacturing Method of Absorbent Body> FIG. 2 and FIG. 3 are views showing an example for a method of manufacturing the absorbent body 110 in which FIG. 2 is a schematic view of an apparatus for fiber opening and laminating fibers and FIG. 3 is an enlarged perspective view for a portion of the laminating device shown in FIG. 2 . As shown in FIG. 2 , the apparatus 200 mainly comprises a fiber opening device 200 A for opening fibers, and a conveyor belt 208 for conveying opened fibers at a predetermined speed and sheeting them. At first, the fiber aggregate before fiber opening is taken up as a take-up roll 201 . Then, a fiber aggregate sheet 202 is delivered therefrom and conveyed by a pair of rolls 203 to the fiber opening device 200 A. The fiber opening device 200 A has a garnet type fiber opening roll 204 in which corrugating blades are arranged in plurality and the fiber aggregate sheet 202 is passed over the fiber opening roll 204 to be opened. In this case, for enhancing the fiber opening performance, it is more preferred that a plurality of rolls 205 , 205 ′ in which tips of corrugating blades arranged in plurality and adjacent with each other are disposed alternately in a zigzag manner are combined such that they rotate in the direction opposite to the rotational direction of the fiber opening roll 204 for passing the fiber aggregate. The method for fiber opening the fiber aggregate is not particularly restricted but selected, for example, from a garnet type and a hammer mill type. It is preferred to conduct fiber opening by the garnet type in which the corrugating blades less fracturing the fibers are arranged in plurality. Further, for enhancing the fiber opening performance more, a plurality of rolls may be combined such that they rotate in the directions opposite to each other. Further, they may be disposed in a zigzag manner such that the tips of corrugating blades arranged in plurality and adjacent with each other are arranged alternately. A fiber aggregate 206 fibers of which have thus opened is drawn under suction from a suction device 207 disposed to the inner surface of a mesh-shaped conveyor belt 208 and laminated as the fiber aggregate 206 on the conveyor belt 208 . Then, a collection speed is given to the opened fiber aggregate 206 by suction soon after the fibers have left from the corrugating blades of the fiber opening roll 204 . In a case where the conveying speed of the conveyor belt 208 is relatively higher than the collection speed of the fiber aggregate 206 , fibers are oriented in the MD direction which is the direction of the arrow in FIG. 2 to form an oriented fiber aggregate 215 and, finally, passed through the rolls 210 , 210 ′ to form a sheet. The MD direction is an advancing direction of the conveyor belt 208 , that is, the advancing direction of the fiber aggregate 206 . As described above, the fiber orientation of the fiber aggregate collected by the conveyor belt 208 can be mainly controlled by the relative difference between the collection speed and the conveying speed. As shown in FIG. 3 , fibers are oriented in the MD direction and an absorbent body 110 is cut into a rectangular shape as shown by dotted lines in FIG. 3 , that is, so as to have a width w and a height h in the state of wearing the inter-labial pad 100 in FIG. 1 . Then, when it is inserted as in the illustrated state between the labia as shown in FIG. 1 , the fiber directions can be aligned in the direction of 10 a to 10 b in which the inter-labial pressure is caused, that is, in the direction of the arrow shown in FIG. 1 , in the state of wearing. <Fiber Constitution> Fibers constituting the absorbent body 110 preferably have a fiber rigidity for obtaining appropriate compressibility and bulk recoverability. The fiber rigidity is generally expressed by Young's modulus (=load/strained amount). In this invention, it is preferred to use fibers having Young's modulus in a range from 100 to 1500 kg/mm 2 and, more preferably, in a range from 300 to 1000 kg/mm 2 . Further, the fiber rigidity can also be controlled by changing the fiber denier and, specifically, it is preferably selected in a range from 1.1 to 8.8 dtex. For the materials of the fibers, natural pulp, chemical pulp, rayon, acetate, natural cotton, super absorbent polymer, super absorbent polymer fiber, synthetic fiber, etc. are used. They may be used alone or a plurality of them may be mixed. Further, it is preferred that they are bulky, less deforming and giving less chemical stimulations. Among those described above, it is preferred that at least a portion of the fibers constituting the absorbent body is synthetic fibers. Since the synthetic fibers are poor in the water absorbability, they tend to easily maintain fiber rigidity even when they absorb menstrual blood in a state of wearing the inter-labial pad. Accordingly, compressibility and bulk recoverability can be maintained during wearing. The synthetic fibers include, for example, polyethylene (PE) fibers, polypropylene (PP) fibers, polyethylene terephthalate (PET) fibers, polyamide (PA) fibers, acrylic fibers, etc. with no particular restriction to them. In order to provide compressibility without giving a foreign-body sensations to a wearer, “bulky” materials are preferred. For example, it is preferred to use physically embossed rayon or acetate. As the “bulky” materials, crimped fibers having crimped structure are also preferred. The crimped fibers include chemical pulp crimped by cross linking using a cross linker, composite fibers such as of PE, PP, PET, etc. described above, which are composite fibers of a core-sheath type, core-sheath eccentric type or side-by-side type by utilizing the difference of the heat shrinkage of respective resins, and those physically crimped spun fibers by engagement, embossing, etc. Further, those enhanced for the molecular orientation by stretching in a state of spinning, or fibers having a profiled cross section such as Y- or C-type cross sectional shape may also be mixed. Furthermore, fibers having the Young's modulus within the range described above and in the form of crimped fibers are more preferred since the fiber orientation partially tends to be directed rightward and leftward, which is substantially the direction of the arrow in FIG. 1 , they tend to be compressed easily so as to be crimped and tend to recover the original shape. Further, for improving the slipping property between the fibers, an oil agent may be coated on or contained in the fibers. For the fiber length, longer fibers are more likely to be entangled for sheeting the collected fiber aggregate, that is, for entangling fibers to each other with the fiber orientation being aligned. Specifically, it is preferred that the fiber length is within a range from 10 to 51 mm and it is more preferred to use mainly those fibers with the average fiber length of from 25 to 50 mm. Specific examples of the fibers described above include mixed fibers comprising (a) from 5 to 100% of synthetic fibers which are of a core-sheath eccentric type of PE and PP, having a fiber denier of 4.4 dtex, a fiber length of 51 mm, and a fiber crimping ratio of 60%, with 0.2% of a hydrophilic oil agent being deposited and (b) from 95 to 0% of rayon having a fiber denier of 3.3 dtex, a fiber length of 51 mm, and a fiber crimping ratio of 50%, with 0.2% of a hydrophilic oil agent being deposited. They are formed into an oriented fiber aggregate 215 in FIG. 2 by relatively increasing the conveying speed to be more than the collection speed. Then, they may be embossed by a dot-shaped emboss pattern, for example, by constituting the rolls 210 , 210 ′ as dot-shaped emboss rolls. In addition to the synthetic fibers and rayon, it is also preferred to incorporate super absorbent polymer or highly compressed fiber lumps. Since this expands the volume after absorbing a body fluid, etc. the volume can be increased relative to the volume before absorbing the body fluid to obtain a further high bulk recoverability. Further, as other highly bulky and less deforming oriented fiber aggregate 215 than described above, non-woven fabric sheeted by a through air method using a plurality kinds of synthetic fibers may also be used alone or being stacked by plural sheets. <Other Example for the Manufacturing Method of Absorbent Body> FIG. 4 shows another manufacturing method for aligning the direction of fibers constituting an absorbent body 110 as shown in FIG. 1 . In this method, contrary to FIG. 3 , the conveying speed of the conveyor belt 208 is relatively lower than the collection speed of the fiber aggregate 206 . In this case, the fiber orientation of the oriented fiber aggregate 216 is in the direction of the thickness of the oriented fiber aggregate 216 which is the direction of the arrow in FIG. 4 . In this case, as shown by dotted lines in FIG. 4 , an absorbent body 111 is cut in a rectangular shape such that the width w corresponds to the direction of the thickness for the oriented fiber aggregate 216 and the height h corresponds to the MD direction of the oriented fiber aggregate 216 in FIG. 1 . Then, when this is put between labia in a state being inverted from the state shown in FIG. 4 by 90°, the direction of the fibers can be aligned in the direction of 10 a to 10 b in which the inter-labial pressure is caused, that is, in the direction of the arrow shown in FIG. 1 in a state of wearing. Fibers of oriented fiber aggregate 216 can be directed to the direction of the thickness by selecting the suction pressure caused to the collected fibers aggregate by way of the mesh-like conveyor belt 208 within a range from 1500 to 15000 Pa, for example, in a case where the conveying speed is within a range from 20 to 200 m/min. When the suction pressure is lower than 1500 Pa, the fibers tend to be directed in the MD direction by the conveying speed. On the other hand, when it is higher than 15000 Pa, the fibers are excessively entangled to the mesh of the conveyor belt, making it difficult to hand the fiber aggregate to the succeeding step. In a case where the suction pressure is selected within a range from 1500 to 15000 Pa, since a collection speed of 4 to 20 m/sec (240 to 1200 m/min) is given to the fibers, and the conveyor belt is conveyed in a range of a speed from 20 to 200 m/min, so that the collection speed given to the fibers becomes relatively higher and the fiber orientation is less directed to MD. Further, after collection, it is necessary that the fiber aggregate is not stretched but conveyed in a state where the fiber orientation in a collected state is substantially maintained as it is. It is preferred not to stretch the fiber aggregate, 216 particularly before embossing step (by rolls 210 , 210 ′) provided for controlling the degree of freedom for the collected oriented fiber aggregate 216 . This is because the fiber orientation of the fiber aggregate is easily directed to the MD direction when the fiber aggregate has been stretched in any steps before embossing, since the degree of freedom of the fiber aggregate is excessively high. Accordingly, it is necessary not to excessively increase the surface speed of the emboss rolls ( 210 , 210 ′) for conducting embossing relative to the surface speed of the conveyor belt 208 on which the fiber aggregate is collected and, specifically, it is preferred that the ratio between the surface speed of the emboss roll and the surface speed of the conveyor belt (surface speed of emboss roll/surface speed of conveyor belt) is preferably within a range from 0.9 to 1.2 and, more preferably, within a range from 1.0 to 1.1. On the other hand, as shown in FIG. 3 , for directing the fiber orientation of the fiber aggregate mainly to the MD direction, the condition may be set in the manner opposite that described above. Second Embodiment <State of Using Inter-Labial Pad> FIG. 5 shows the state of using an inter-labial pad 300 according to a second embodiment of the present invention. As shown in FIG. 5 , the inter-labial pad 300 is constituted such that an absorbent body 310 is folded in two along a crease 311 and a portion along the crease 311 being put between the labia 10 a and 10 b. <Manufacturing Method of Absorbent Body> FIG. 6 shows an example for the method of manufacturing an absorbent body 310 . In the same manner as shown in FIG. 4 , the conveying speed of a conveyor belt 208 is relatively lower to the collection speed of fibers 206 . Accordingly, the fiber orientation of an oriented fiber aggregate 216 is in the direction for the thickness of the oriented fiber aggregate, which is the direction of an arrow shown in FIG. 6 . In this case, the absorbent body 310 is cut into a rectangular shape by the dotted lines as shown in FIG. 6 such that the width w′ in FIG. 5 corresponds to the direction of thickness for the oriented fiber aggregate 216 in FIG. 6 , doubled height for h′/2 in FIG. 5 corresponds to the lateral direction h′ of the oriented fiber aggregate 216 . Then, when it is folded along the crease 311 and put between the labia, the fiber direction can be aligned along the direction of 10 a to 10 b in which the inter-labial force is caused in a state of wearing. That is, fibers may be aligned in the direction of the arrow in FIG. 1 . Third Embodiment <State of Using the Inter-Labial Pad> FIG. 7 shows a state of using an inter-labial pad 400 according to a third embodiment of the present invention. As shown in FIG. 7 , the inter-labial pad 400 is different from that shown in FIG. 5 in that a convex portions 415 and a concave portion 416 are formed alternately along the direction vertical to a crease 411 on the surface of an absorbent body 410 . <Manufacturing Method of Absorbent Body> The absorbent body 410 can be obtained by the manufacturing method as shown in FIG. 8 . That is, as shown in FIG. 8 , a plate 250 that gradually restricts the thickness of the fiber aggregate 206 is located above a conveyor belt 208 . Since the plate 250 constitutes resistance to the fiber aggregate 206 being conveyed and the fiber aggregate 206 is conveyed being deformed in a corrugated shape, the fiber orientation of the fiber aggregate is directed to the direction of the thickness as a whole. In the succeeding step, the absorbent body 410 is cut into a substantially rectangular shape having a corrugated surface by the dotted lines as shown in FIG. 8 . Then, when it is folded along a crease 311 , and put between the labia, the fiber direction can be aligned along the direction of 10 a to 10 b in which the inter-labial pressure is caused, that is, in the direction of the arrow in FIG. 7 . In addition to the method described above, the conveyor belt 208 may be previously formed into a corrugated shape upon collecting the fiber aggregate 206 . Also in this constitution, the fiber aggregate 206 is collected profiling the shape of the conveyor belt 208 . Fourth Embodiment <State of Using Inter-Labial Pad> FIG. 9 shows a fourth embodiment of an inter-labial pad according to the present invention. An inter-labial pad 500 is different from the embodiment shown in FIG. 5 in that embossing 512 is applied to the surface of an absorbent body 510 . Reference numeral 511 denotes a crease. <Manufacturing Method of Absorbent Body> Such embossing can be conducted, for example, by constituting rolls 210 , 210 ′ in FIG. 2 as emboss rolls. That is, by embossing, since the fiber orientation at the portion is partially aligned in the direction of the thickness of the fiber aggregate, the same effect as that of the embodiment described above can be obtained. An emboss pattern is not particularly limited so long as the fiber orientation is directed to the direction of the thickness of the fiber aggregate and it may be a dot-shape or lattice-shape, as well as a corrugated shape causing deformation as shown in FIG. 8 . Among them, a dot-shape emboss pattern is preferred considering a flexibility giving less foreign-body sensation to a wearer. Specifically, embossing can be applied, for example, by a dot-shape emboss pattern arranged in a zigzag manner with an embossing area ratio of 0.5%, a pin diameter of 1.0 mm and a pitch of 12.5 mm. With this constitution, since the fiber orientation is partially directed to the direction of the thickness at the instance the fibers are collected and, in addition, fibers at the periphery of the dot-like embossing are enforced by the pins in the direction of the thickness and joined by hot melting, the fiber orientation at the periphery of the dot-shape embossing is further directed to the direction of the thickness and becomes more firm. The dot-shape embossing area ratio is, preferably, within a range from 0.3 to 60%. As other examples than the embossing as described above of controlling the fiber orientation upon sheeting the collected fiber aggregate, a needle punching manufacturing method of directing the fiber orientation at the needled portion to the direction of the thickness by applying needling in the direction of the thickness thereby entangling the fibers to each other, and a spun lace manufacturing method of hitting a water jet in the direction of the thickness thereby directing the fiber orientation at the portion undergoing a water pressure to the direction of the thickness and entangling the fibers to each other by the water jet, etc. may also be used. Fifth Embodiment <State of Using Inter-Labial Pad> FIG. 10 shows a fifth embodiment of an inter-labial pad according to the present invention. Further, FIG. 11 shows a perspective view showing a state of attaching the inter-labial pad according to the fifth embodiment, FIG. 12 is a cross sectional view taken along line X 1 -X 2 in FIG. 11 and FIG. 13 is a cross sectional view taken along line Y 1 -Y 2 in FIG. 11 . An inter-labial pad 600 comprises, as shown in FIG. 10 , a surface side sheet 620 in contact with labia 10 in the state of wearing, a back face sheet 630 disposed so as to stack over the surface side sheet 620 and not in contact with the labia 10 , an absorbent body 610 interposed between the surface side sheet 620 and the back face sheet 630 , and a pair of portions 650 a , 650 b of at least one elastic sheet member 650 is disposed vertically centered between the longitudinal crease and bottom fold of the interlabial pad, each portion of the pair of portions 650 a , 650 b being interposed between the absorbent body 610 and the back face sheet 630 in symmetry with respect to the longitudinal center axis of the inter-labial pad 600 . The absorbent body 610 prevents each portion 650 a , 650 b of the at least one elastic sheet member 650 from contacting the surface side sheet 620 . The inter-labial pad 600 is in substantially a longitudinal shape having a longitudinal direction and a shorter direction as a whole and folded along the longitudinal crease such that a pair of portions 630 a , 630 b of the back face sheet 630 are opposed to each other, and put with a portion along the crease being put between the labia. The fiber direction of the absorbent body 610 is aligned along the direction of the arrow in FIG. 10 like that in FIG. 5 . Each portion of the pair of portions 650 a , 650 b is opposed to the other portion and each portion of the pair of portions 650 a , 650 b is in contact with a respective one of the pair of portions 630 a , 630 b of the back face sheet. <Example of Elastic Sheet> The location where the elastic sheet 650 is disposed is not particularly limited and it may be disposed between the surface side sheet 620 and the absorbent body 610 , may be disposed in the absorbent body 610 or at the back of the back face sheet 630 . The back face sheet 630 per se may be the elastic sheet 650 . In view of the liquid absorbability and flexibility, the elastic sheet 650 is preferably disposed on the side of the absorbent body 610 at the back face sheet 630 . Further, the elastic sheet 650 is preferably disposed in symmetrical with the crease as an axis of symmetry. Furthermore, it may be disposed so as to override the crease. The size of the elastic sheet 650 is not particularly limited and it is preferably equal with or less than the size of the absorbent body 610 in view of the flexibility. Further, for the thickness, it is preferably within a range from 0.5 to 5 mm in view of the flexibility. As specific examples of the elastic sheet 650 , laminates of elastic fibers, films, foamed materials having air cells, etc. can be mentioned. The elastic fibers include thermoplastic materials such as PE, PP, PET, etc., and each of the resins is preferably used alone or as composite fibers of core-sheath type, core-sheath eccentric type, side-by-side type. Further, fibers applied with secondary crimping, for example, by mechanical crimping or heat are preferred because of more elasticity. In view of the feeling of wear with respect to elasticity and rigidity, those fibers controlled to a fiber denier of 0.5 to 88 dtex and a fiber length of 3 to 64 mm are used preferably. A laminate of elastic fibers include non-woven fabrics. In this case, non-woven fabrics obtained by laminating fibers by carding, and being formed by a through air manufacturing method of bonding by hot melting of thermoplastic fibers can provide repulsive elasticity and can be used preferably. Generally utilized point bonding, spun bonding or spun lace method can also be utilized. Spun bonded non-woven fabrics of spinning continuous filaments and bonding them by heat embossing can also be utilized. Further, SMS (spun bonded layer/melt blown layer/spun bonded layer) non-woven fabrics bonded by blowing melt-blown fibers to spun bonds can also be utilized, and chemical bonding or an air laid method by coating a binder to the surface after the fiber lamination can also be utilized. The materials described above may be used in a single layer or may be multi-layered and fixed by an adhesive material or embossing. Further, those materials controlled for the compressibility or bulk recoverability to a predetermined direction by an embossing pattern can also be utilized preferably. As the film, those materials obtained by extruding resins such as elastic PE, PP, PET or further higher elastic urethane or rubber by T-die or inflation method can be utilized. In the extrusion, a single material may be used, plural materials may be extruded as a multi-layered form, or plural layers may be laminated into a composite form. As the foamed materials having air cells, those materials obtained by foaming resins such as elastic PE, PP or higher elastic urethane or rubber and, further, cellulose sponge having absorbability can be utilized. The foamed materials may be of open cell or closed cell type. The elastic sheet 650 and the absorbent body 650 described above are preferably used in combination while aligning the fiber direction, but they may be used alone respectively. <Place for Locating Elastic Sheet> As shown in FIG. 11 , since the shape of female labium minus pudendi is thicker and longer in the forward portion compared with the backward portion, the inter-labia pressure is higher and the fluctuation of the inter-labia pressure is also greater in the forward portion. In FIG. 11 , the direction A shows the forward direction of the labia and the direction B shows the backward direction of the labia. Accordingly, it is also preferred to control the compressibility and the bulk recoverability between the forward portion and the backward portion. That is, it is preferably constituted such that the compression ratio and the bulk recoverability are higher in the forward portion than those in the backward portion. Further, as shown in FIG. 12 and FIG. 13 , the elastic sheet 650 may be disposed only in the forward portion. FIG. 12 is a cross sectional view along line X 1 -X 2 in FIG. 11 , that is, for the forward labial portion, while FIG. 13 is a cross sectional view along line Y 1 -Y 2 in FIG. 11 , that is, for the backward labial portion. As can be seen from FIG. 12 and FIG. 13 , the elastic sheet 650 is disposed only at the forward portion of the inter-labial pad 600 ( FIG. 12 ) and the elastic sheet 650 is not disposed in the backward portion thereof. Further, one or plural slits may also be disposed along the shorter direction of the inter-labial pad 600 from the forward to the backward portions. Thus, since the external pressure applied strongly to the forward portion of the inter-labial pad 600 is separated by the slit portions, the external pressure is less propagated backward of the inter-labial pad. Specifically, as shown in FIG. 14 , for example, it is preferred that perforated slits 660 a , 660 b and 660 c are formed in a zigzag slit pattern such that the slit length is from 5 to 20 mm along the longitudinal direction of the inter-labial pad 600 , and the slit pitch is from 5 to 20 mm along the longitudinal direction of the inter-labial pad 600 . The direction A shows the forward direction of the labia while the direction B shows the backward direction of the labia. <Example of Surface Side Sheet> For the surface side sheet 620 , those materials which are water permeable and give less stimulations to skins are used. They include, for example, those non-woven fabrics obtained by a manufacturing method such as a point bonding or through air method, which are used alone or in a composite form. Among the materials, those mainly comprising at least hydrophilic cellulosic fibers are preferred in view of the affinity with the inter-labial inner walls so that deviation is not caused between the inter-labial pad and the labial inner wall to give a foreign-body sensation to a wearer. Specifically, spun laced non-woven fabrics obtained by mixing from 5 to 30% of natural cotton and from 70 to 95% of rayon or acetate, conditioning to a range from 20 to 50 g/m 2 , then entangling fibers to each other by water jet entanglement followed by drying and conditioning the thickness within a range from 0.3 to 1.0 mm are preferred. The thread material used in this case is selected materials having a fiber denier of within a range from 1.1 to 6.6 dtex and a fiber length from a range of 15 to 60 mm for natural cotton and from a range of 25 to 51 mm for rayon or acetate. Further, they may be also films having perforated apertures or fiber layers laminated with films and having perforated apertures. <Example of Back Face Sheet> As the back face sheet 630 , any material capable of preventing menstrual blood kept in the absorbent body 610 from leaking to the outside of the inter-labial pad may be used. Further, by the use of moisture permeable materials, steaming during wearing can be decreased and uncomfortable feeling during wearing can be reduced. The materials of the less water permeable sheet include polyethylene, polypropylene, polyethylene terephthalate, polyvinyl alcohol, polylactic acid, polybutyl succinate, non-woven fabric, paper and laminate materials thereof at a thickness from 15 to 60 μm. Further, the materials may also be an air permeable film obtained by filling inorganic fillers and applying stretching. Specifically, they include films mainly comprising low density polyethylene resin and conditioned within a range of basis weight per unit area of from 15 to 30 g/m 2 , and further, air permeable films controlled within a range of an open pore area percentage of from 10 to 30% and an aperture diameter of from 0.1 to 0.6 mm. Example of the non-woven fabrics include spun bonded non-woven fabric, point bonded non-woven fabric, and through air non-woven fabric, etc. which may be applied with a water repelling treatment. Among them, SMS (spun bond/melt-blown/spun bond) non-woven fabrics containing melt-blown fibers constituted with ultrafine fibers and with extremely small inter-fiber distance are preferred. In this case, it is preferred to constitute within the range of basis weight per unit area of from 5 to 15 g/m 2 for the spun bonded layer, from 1 to 10 g/m 2 for the melt-blown layer and from 5 to 15 g/m 2 for the spun bonded layer. <Example for Bonding Absorbent Body and Surface Side and Back Face Sheets> As the specific method for bonding the absorbent body and the surface side sheet and the back face sheet, known-techniques such as adhesives or embossing seal can be used. The adhesive coating pattern includes, for example, spiral coating, controlled seam coating, coater coating, curtain coater coating and summit gun coating. Among them, the summit gun coating capable of making the pitch finer between bonded portion and non-bonded portion is preferred. The basis weight per unit area of the adhesive is within a range from 1 to 30 g/m 2 , preferably, from 3 to 10 g/m 2 . Further, in a pattern where the adhesive is coated linearly, the line width is preferably within a range from 30 to 300 μm. In a case where the basis weight is 1 g/m 2 or less, or the line width is less than 30 μm, when the surface side sheet 620 is constituted with a fiber aggregate, the adhesive is buried between the fibers failing to provide a sufficient bonding force. On the other hand, in a case where the basis weight per unit area is more than 30 g/m 2 or the line width is more than 300 μm, the peripheral portion becomes rigid. There is no particular restriction for the portion coated with the adhesive and it is preferred that the adhesive is coated at least between the absorbent body and the back face sheet. The emboss pattern may be a lattice-shape, dot-shape, corrugated shape, etc. with no particular restriction. The location for emboss sealing also has no particular restriction and it is preferred that emboss sealing is applied for the surface side sheet and the back face sheet extending along the peripheral edge of the absorbent body together. <Example of a State of Wearing and a Shape of Inter-Labial Pad> While the depth of the labia is different depending on the individual since it is about 14 mm as an average value, a region put between the labia is in a region within 14 mm from the vestibular floor in the vertical direction attached to the labia. Further, in an inter-labial pad in which the shape changes before and after attachment in the labia, for example, an inter-labial pad folded along the longitudinal center line as an axis of fold such that the portions of the back face sheet are opposed to each other during wearing, the region is within 14 mm in both outward directions from the longitudinal center line respectively. Further, the region put between the labia along the longitudinal direction is 50 mm forward and 5 mm backward to the ostium vaginae since the length of the labia is generally 55 mm as the average value. Accordingly, the region put longitudinally between the labia is a region within 50 mm for the forward and within 5 mm for the backward from the position in contact with the ostium vaginae. The shape of the inter-labial pad is not particularly limited so long as it is a shape that conforms the female labia such as elliptic shape, hour glass shape or droplet shape. The total size for the outer profile is preferably from 40 to 180 mm and, more preferably, 80 to 120 mm in the longitudinal direction. Further, it is preferably from 20 to 100 mm and, more preferably, from 50 to 80 mm in the lateral direction. The inter-labial pad may be contained entirely in the labia or may have a region exposing out of the labia. <Individual Wrapping Container for Inter-Labial Pad> The inter-labial pad according to the invention is preferably contained further in an individual wrapping container. The materials for the individual wrapping container include polyethylene, polypropylene, polyethylene terephthalate, polyvinyl alcohol, polylactic acid, polybutyl succinate, non-woven fabric, and paper, as well as laminate materials thereof, at a thickness of from 15 to 60 μm. Specifically, they include films, formed by mixing low density polyethylene ranging from 0 to 80% and high density polyethylene ranging from 100 to 20% and controlling the basis weight per unit area within a range from 15 to 35 g/m 2 . Further, films applied with stretching for improving the resin orientation may also be used. Examples of non-woven fabrics include spun bonded non-woven fabrics, point bonded non-woven fabrics, and through air non-woven fabrics, which may be applied with a water repelling treatment. Among them, SMS non-wove fabrics containing melt-blown fibers constituted with ultrafine fibers with extremely small inter-fiber distance are preferred. In this case, it is preferred that they are constituted with the basis weight per unit area within a range from 5 to 15 g/m 2 for a spun bonded layer, from 1 to 10 g/m 2 for a melt-blown layer and from 5 to 15 g/m 2 for a spun bonded layer. Further, it is preferred that the individual wrapping container can shield the color of the menstrual blood absorbed in the inter-labial pad and may be mixed with a pigment in a range from 0.2 to 10%, or applied with printing on the surface, for example, with an ink. Further, the inter-labial pad or the individual wrapping container may comprise a water disintegratable material or biodegradable material so that the pad can be flushed away. [Compressibility and Bulk Recoverability] The compressibility and the bulk recoverability in the present invention can be estimated by the following method. At first, predetermined compressibility and bulk recoverability in the present invention are preferably the compressibility and the bulk recoverability in a moistened state of absorbing a body fluid. As an evaluation method for the compressibility in the moistened state of absorbing the body fluid, the thickness of the inter-labial pad after pressurization at 50 g/cm 2 for 3 min in a state where the inter-labial pad absorbs an artificial body fluid seven times as much as the mass of the absorbent body is measured and the ratio relative to the thickness of the inter-labial pad before absorption of the artificial body fluid is measured. This is defined as a compression ratio. In the inter-labial pad according to the invention, the compression ratio is, preferably, 30% or more and, more preferably, 30% or more and 80% or less. As an evaluation method for the bulk recoverability in the moistened state of absorbing the body fluid, the thickness of the inter-labial pad after pressurization at 50 g/cm 2 for 3 min and further leaving under no pressure for 2 min in a state where the inter-labial pad absorbs an artificial body fluid seven times as much as the mass of the absorbent body is measured and the ratio relative to the thickness of the inter-labial pad before absorption of the artificial body fluid is measured. This is defined as a bulk recovery ratio. In the inter-labial pad according to the present invention, the bulk recovery ratio is preferably 60% or more and, more preferably, 60% or more and 150% or less. The artificial body fluid used for the evaluation described above includes an artificial menstrual blood prepared as follows. An example of specific composition in a case of using the artificial menstrual blood includes, for example, a solution of a composition comprising 32 mass parts of sodium carboxymethyl cellulose, 320 mass parts of glycerin, 40 mass parts of sodium chloride, 16 mass parts of sodium hydrogen carbonate, 32 mass parts of food pigment preparation Red No. 102, 8 mass parts of food pigment preparation Red No. 2, and 8 mass parts of food pigment preparation Yellow No. 5, with no restriction thereto. EXAMPLE The present invention is to be described more specifically with reference to examples and comparative examples. The compressibility and bulk recoverability in the present invention concern not only the absorbent body but also the entire inter-labial pad. However, in the following examples and comparative examples, the values for the compressibility and bulk recoverability of the entire inter-labial pad after releasing compression were measured only for the absorbent body. This is because most of the factors giving an influence on such physical values are attributable to those of the absorbent body occupying a major portion of the weight for the entire inter-labial pad. Example 1 Using 100% of pulp with a fiber length of 1 to 8 mm, as shown in FIG. 4 , fibers were fiber-opened by an air laid method using a garnet type fiber opening method while increasing the collection speed relative to the conveying speed, amending them by suction such that the basis weight per unit area was 700 g/m 2 , conveying them so as not to apply excess tension during the conveying step and then applying embossing at an embossing ratio of 0.5% with a dot-shape emboss pattern, to manufacture an absorbent body. The lamination conditions were at an attraction pressure under suction of 7000 Pa, at a conveying speed of 80 m/min, and at an emboss roll circumferential speed/conveyor belt circumferential speed of 1.2. Further, in the dot-shape emboss roll, pins each of 1.0 mm diameter are arranged in a dot-pattern (1.0 mm diameter means a diameter at the pin tip and the diameter at the pin bottom was 2.6 mm) at a pitch of 12.5 mm and arranged in a zigzag manner. Example 2 An absorbent body was manufactured under the same conditions as those in Example 1 except for using fibers formed by mixing 85% of rayon with a fiber denier of 3.3 dtex having a fiber length of 51 mm, fiber crimping ratio of 50%, and deposited with 0.2% of a hydrophilic oil agent, and 15% of natural cotton. Example 3 Using 100% synthetic fibers of PE-PP core-sheath eccentric type with a fiber denier of 4.4 dtex having a fiber length of 51 mm, fiber crimping ratio of 60% and deposited with a hydrophilic oil agent of 0.2%, the synthetic fibers were sheeted into a non-woven fabric of 20 g/m 2 by a through air method, the non-woven fabric was stacked by 35 sheets so as to be 700 g/m 2 and then embossing was applied in the same manner as in Example 1. Example 4 (a) Using the same 100% synthetic fibers as in Example 3, the synthetic fibers were fiber-opened by an air laid method using a garnet type fiber opening method while increasing the collection speed relative to the conveying speed, and they were collected by suction such that the basis weight per unit area was 100 g/m 2 as shown in FIG. 4 . (b) On the other hand, a non-woven fabric formed by sheeting the synthetic fibers described above by a through air manufacturing method into 20 g/m 2 was stacked by 13 sheets so as to be 260 g/m 2 . (a) was placed over (b) and the same embossing as in Example 1 was applied. Then, it was folded with the central axis as the start point. As the lamination conditions, the suction pressure was set to 4,000 Pa and other conditions were set in the same manner as in Example 1. Comparative Example 1 Articles, trade name of: “Envive” manufactured by Procter & gamble Co. in the prior art described above were used as they were. Test Example Compression ratio and bulk recovery ratio were measured for the absorbent bodies of Examples 1 to 4 and Comparative Example 1. Table 1 shows the results. The measurement for the compression ratio and the bulk recovery ratio were evaluated in accordance with the test method as described in [Compressibility and bulk recoverability] and, as an artificial menstrual blood, a solution of a composition comprising 32 mass parts of sodium carboxymethyl cellulose, 320 mass parts of glycerin, 40 mass parts of sodium chloride, 16 mass parts of sodium hydrogen carbonate, 32 mass parts of food pigment preparation Red No. 102, 8 mass parts of food pigment preparation Red No. 2 and 8 mass parts of food pigment preparation Yellow No. 5 was used. TABLE 1 Comparative No. Example 1 Example 1 Example 2 Example 3 Example 4 Sample Upper layer Manufacturing envive Fiber opening Fiber opening Through air Fiber opening lamination method lamination lamination stocked by 35 sheets of 20 g/m 2 Raw material 100% - Pulp 85% - Rayon → PE-PP core- PE-PP core-eccentric type → fiber length fiber denier eccentric type fiber: 100% → fiber denier of 1-8 mm of 4.4 dt × fiber: 100% → of 4.4 dt × fiber length of 51 fiber length fiber denier of mm of 51 mm 15%- 4.4 dt × fiber Natural cotton length of 51 mm Basis weight 100 g/m 2 per unit area Lower layer Manufacturing Through air stacked by 13 method sheets of 20 g/m 2 Raw material PE-PP core-eccentric type fiber: 100% → fiber denier of 4.4 dt × fiber length of 51 mm Basis weight 260 g/m 2 per unit area Settled total g/m 2 700 700 700 360 basis weight per unit area Processing Dot-shape Dot-shape Dot-shape Dot-shape emboss emboss emboss emboss Shape putted Two-folded Rectangular Rectangular Rectangular Two-folded to labia shape shape shape Dry Weight g 1.02 1.02 1.01 1.24 1.19 <1> Thickness → mm 5.98 6.52 6.8 8.48 9.21 6.1 g/cm 2 or less Density g/cm 3 0.085 0.104 0.099 0.097 0.086 Wet → <2> Thickness mm 2.97 3.36 3.65 4.43 4.19 Absorption upon compres- magnification: sion → 50 g/cm 2 7 fold or less Thickness after mm 3.52 3.98 4.58 6.72 7.81 releasing of com- pression → 6.1 g/cm 2 or less <3>/<1> × 100 % 59 61 67 79 85 Recovery ratio (<1> − <2>)/ % 50 48 46 48 55 <1> × 100 Compression ratio From the result of Table 1, the bulk recovery ratio was 61% and the volume after releasing compression was 3.98 mm in Example 1, and the bulk recovery ratio was 67% and the volume after releasing the compression was 4.58 mm in Example 2, all of the values were higher compared with the bulk recovery ratio of 59% and the volume of 3.52 mm after releasing the compression in Comparative Example 1. This is because, in Comparative Example 1, since the direction of the fibers of the absorbent body was aligned in front-to-back direction, in a state where pressure was added and menstrual blood was absorbed, other fibers were further intruded between fibers to shorten the distance between the fibers, and this reduced the thickness of the absorbent body to result in lowering of bulk recoverability. On the other hand, in Example 1 and Example 2, since the fiber orientation was partially directed to the direction of the thickness upon collection, the bulk recoverability was increased by the rigidity of the fibers. Further, the values in Example 2 were higher than those in Example 1, this is because, since the fiber length was longer than that in Example 1, other fibers were less intruded between fibers. In Example 3, the bulk recovery ratio was 79% and the bulk after releasing compression was 6.72 mm. It is considered that since the fibers were crimped synthetic fibers, the fiber rigidity was scarcely lowered and the fiber tended to recover the original shape even in a moistened state and, in addition, the embossed portions were press-bonded by heating, and the fiber orientation directing to the direction of the thickness was more firm. In addition, since the sheet per se was a through air non-woven fabric being melted by heat at entangling points between each of fibers, the bulk recovery ratio was high even in a more moistened state. In Example 4, the compression ratio was 55% and the bulk recovery ratio was 85%. The compression ratio was high because the fibers at the upper layer were bonded only at embossed portions and, accordingly, the degree of freedom of the fibers with each other was high, which gave less foreign-body sensation to a wearer. In addition, it is considered that the bulk recovery ratio was higher than that in Example 2 because repulsive force tending to return to the original shape was applied due to folding at the center axis. The present invention can be used as an inter-labial pad which is put at a portion thereof between the female labial space and abutting it at the inner surface of the labia in wearing.

1a

CROSS REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application Ser. No. 60/320,147 filed on Apr. 25, 2003. The entire disclosure is incorporated by reference herein. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT Not applicable. REFERENCE TO SEQUENCE LISTING, A TABLE, OR COMPUTER PROGRAM LISTING Not applicable. BACKGROUND OF THE INVENTION (1) Field of the Invention This invention is directed toward pool cues used in games that are played on a billiard table such as pool, billiards, snooker, and the like. The pool cue of this invention is a hollow shaft wherein a mechanical spring loaded mechanism is activated inside the cue so that the cue tip is projected outward to strike a billiard ball. The striking force may be varied by an adjustment at the end of the cue. The design of the cue looks very similar to a standard pool cue that is manually struck against the billiard ball. The cue is designed to be disassembled for convenient storage and transport. (2) Description of Related Art U.S. Pat. Nos. 6,348,006, 5,628,691, 4,949,964, and 4,718,671 all disclose various methods of creating a variable length cue stick. The methods in these patents include screw assembly and telescoping. Various locking methods are disclosed to fix the telescoping length. U.S. Pat. No. 5,411,441 discloses a cue tip that is spring loaded in connection with a silicone encasement. The goal is to provide additional momentum to the ball when struck. U.S. Pat. No. 5,299,983 discloses a spring activated cue using a ratchet and pawl. The invention is overly complicated in order to move the cue tip forward and backward, and most of the cue length moves relative to the end which contains the spring actuation mechanism. This makes it difficult for an operator to hold and aim correctly. U.S. Pat. No. 4,634,123 discloses a spring activated cue using a saw tooth ratchet mechanism that locks the cue tip inside the hollow cue shaft. It is difficult for the operator to know exactly where the cue tip will strike the ball as the cue tip is recessed within the hollow cue. U.S. Pat. No. 4,526,370 discloses a spring activated cue designed with two pieces: a moving portion and a fixed portion. The moving portion is difficult for the operator to hold steady and strike on the desired ball spot when suddenly activated. U.S. Pat. No. 4,134,588 discloses a spring activated cue tip for a shorter cue length with an awkward push button and method to vary the striking force. The striking force is restricted to a few select forces and is not continuously adjustable. U.S. Pat. No. 3,447,805 discloses a spring activated cue. Similar to U.S. Pat. No. 4,526,370 the moving portion is difficult for the operator to hold steady and strike on the desired ball spot when activated. Also the striking force is restricted to a few select forces and is not continuously adjustable. U.S. Pat. No. 1,604,023 discloses a spring activated cue tip with a moving stock piece at the end of the cue. When activated, the device is designed for the cue tip to strike the ball and return to the latched position. To do this, a stock piece at the other end pops out. The end stock piece is then pressed inward to reset the device. There is additional internal undesirable movement that disturbs the aim of the operator and makes the striking force less predictable. U.S. Pat. No. 1,182,530 discloses a spring activated cue tip that includes two springs and a gun trigger type of release mechanism. A primary forcing shaft strikes a secondary shaft which is attached to the cue tip. The energy needed to activate the device is set by a sliding collar. The collar is troublesome and the operator must remember to slide it to the proper forward position or the device activation will impact the collar which is liable to hurt the operator's hand. The gun trigger is an unnatural and undesirable way of holding a cue, making the cue awkward to aim. U.S. Pat. Nos. 673,753 and 673,693 both disclose a spring activated cue. Similar to U.S. Pat. No. 4,526,370, the suddenly moving portion is difficult for the operator to hold steady and strike on the desired ball spot when activated. Two springs are used to create the striking energy and also retract the moving portion partially into the fixed portion. In addition, in U.S. Pat. Nos. 4,634,123, 4,526,370, 4,134,588, and 3,447,805 the adjusting mechanism provides a higher striking force with the longer ball striking movement which is undesirable as a longer cue may contact other balls causing a game violation. None of the above disclosed spring activated devices provide for operator convenience in traveling or storage. There has been no consideration for convenient disassembly for a more convenient length suitable for a carrying or storage nor has there been consideration for economic and simplified manufacturability. BRIEF SUMMARY OF THE INVENTION This invention is directed toward a piece pool cue that is designed to strike the cue ball with a cue tip that is spring activated and also overcomes the problems just mentioned with similar devices. The device has also been specifically designed to be taken apart for storage, transport, and easy repair. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S) FIG. 1 is a general arrangement of the spring activated pool cue as a cross section. FIG. 2 is a detail of a release cylinder used in the activation mechanism. FIG. 3 is a detail of a retaining ring for the release button. DETAILED DESCRIPTION OF THE INVENTION FIG. 1 shows a general arrangement cross section of the pool cue as conceived in this invention. To aid in understanding this general arrangement, the pool cue is made up of the following items. No. Description 10 Release mechanism cavity 11 Trigger release button spring 12 Trigger release button 13 Release cylinder 14 Barrel spring 15 End plate 16 Threaded rod 17 Threaded bushing 18 Tension adjustment coupler 19 Rear impact rod 20 Stop edge 21 Front impact rod 22 Pin 23 Machined tip 24 End impact tip 25 Threaded connection for cue barrels 26 Threaded connection for impact rods 28 Rear cue barrel 30 Front cue barrel 31 Contact point 33 Barrel taper 35 Drilled opening in rear cue barrel 40 Machined recess The cue is made up of two elongated barrels, a front cue barrel 30 and a rear cue barrel 28 . Both barrels may be made from materials such as aluminum, titanium, graphite, and wood. A preferred embodiment is to begin with a solid aluminum dowel or billet. The overall length of the cue can vary from a typical four and one half feet long to any length specified by a prospective owner. The barrel outside diameter is preferably 1.25 inches. The barrels are preferably made by drilling length wise with a gun drill bit to bore ⅛ inch hole or a 3/16 inch hole as illustrated to allow the front impact rod 21 and rear impact rod 19 to freely move. A taper 33 in machined on the outside diameter the front cue barrel 30 and rear cue barrel 28 to match existing cue designs. The outside of the barrels can be given a high quality machined or polished finish. It should be noted that FIG. 1 is not drawn to scale. The length is shortened for the sake of showing the important features of the invention. The front cue barrel 30 and rear cue barrel 28 are carefully machined so that they can be screwed together by male and female threads 25 near the middle of the overall cue length. The machining must be done carefully to ensure that the mating surfaces keep the overall cue assembly straight. The rear cue barrel 28 is also drilled or machined out, preferably to ⅝ inches in diameter and 4 to 6 inches deep, to allow the barrel spring 14 and release mechanism assembly to be inserted into the cue. A stop edge 20 illustrates where the diameter changes. The end diameter of the rear cue barrel 28 is also machined to allow room for the tension adjustment coupler 18 to be assembled. The rear cue barrel 28 is also drilled out 35 , preferably to ⅜ inches in diameter and just deep enough to allow the trigger release button 12 and the trigger release button spring 11 to be inserted. A spring release mechanism cavity 10 is created inside the rear cue barrel 28 by the machining and drilling. The barrel spring 14 and release mechanism assembly is designed to provide for continuously variable energy storage in the barrel spring and provide for a fixed stroke length for striking a billiard ball. The energy stored in the barrel spring 14 is adjusted by an assembly of four parts. A threaded rod 16 is firmly fixed to a threaded tension coupler 18 and an end plate 15 so that they all rotate together. A threaded bushing 17 is fixed to the end of the rear cue barrel 28 by a pin or other means. When the tension adjustment coupler is turned, the threaded rod 16 turns inside the threaded bushing 17 and causes the end plate 15 to move and compress the barrel spring 14 . This assembly provides for a continuously variable amount of stored energy. The stiffness of the spring may be designed to the preference of the owner. The trigger release assembly consists of three important parts. A trigger release button 12 is inserted in the rear cue barrel and also in a release cylinder 13 . A trigger release button spring 11 is under the trigger release button 12 . The mechanism is shown in the locked position with spring force being applied to the trigger release button. When the trigger release button 12 is pressed into the rear cue barrel 28 , the contact 31 between the trigger release button 12 and the release cylinder 13 is removed and the release cylinder 13 then slides forward until the stop edge 20 prevents movement. The trigger release button 12 is machined to a shape that matches slots in the release cylinder 13 to allow the motion to occur. The trigger release button spring 11 helps to prevent unwanted activation of the pool cue by keeping the trigger release button 12 in the locked position until activated by the owner. It also provides for a convenient re-locking action on the trigger release button 12 when getting ready for the next pool shot. A machined recess 40 on the release cylinder 13 provides support for the barrel spring 14 and optionally includes room for a washer to ensure a smooth turning for the barrel spring 14 when the spring compression is adjusted. When the release cylinder 13 is allowed to slide forward, it then pushes the rear impact rod 19 forward. The rear impact rod 19 is firmly threaded into the release cylinder 13 . The rear impact rod 19 is connected to a front impact rod 21 by a threaded connection 26 . The front impact rod 21 is connected to a machined tip 23 which is attached by a pin 22 or other means. The machined tip 23 is then attached to an end impact tip 24 which will actually strike the billiard ball. The attachment design for the end impact tip 24 may be by glue, threading, press fit, or other mounting means. The end impact tip 24 may be a typical material used in pool cues as desired by the owner. The attachment may include the use of a knurled or threaded hole. Various designs may be used that allow a quick change. The pool cue may be disassembled for storage by first unscrewing the front impact rod 21 and then unscrewing the front cue barrel 30 . The rear impact rod 19 is prevented from rotating because the release cylinder 13 is prevented from rotating by the trigger release button 12 . The pool cue is reset for the next shot merely by pushing the impact rods and tip assembly back into the cue. The trigger release button spring 11 pushes the trigger release button 12 into the locked position and which holds the cue ready for the next shot. FIG. 2 shows a detail of the release cylinder 13 in a view in the same direction as the release button motion. An enlarged eyehole 39 is designed to engage a larger diameter of the trigger release button 12 and provide a smaller diameter slot 32 that will slide past the trigger release button 12 when the invention is activated. FIG. 3 shows an additional important detail that is omitted in FIG. 1 . A machined aluminum retainer ring 41 is added to the outside diameter of the rear cue barrel 28 . It slides over the length of the cue in the direction as illustrated to lock the trigger release button 12 inside the rear cue barrel 28 and prevent it from falling out. The retainer ring 41 has an outside diameter small enough to allow the trigger release button 12 only enough motion to perform its function and not spring out. In general, the cue can be modified as per the desires of the owner. The overall design provides for the use of a variety of materials. Also the cue exterior may be modified by various paints, surface textures, anodizing, and knurling. This invention lends itself very readily to the use by persons with handicaps or disabilities. This invention may be adapted in length to fit for use by the preference or need of the owner. This cue barrels have been designed, in a preferred embodiment, to be made by the use of standard machining techniques from an aluminum dowel or billet. This allows the customization of the cue to the length, surface texture, and appearance specified by an owner. While various embodiments of the present invention have been described, the invention may be modified and adapted to various similar pool cues to those skilled in the art. Therefore, this invention is not limited to the description and figure shown herein, and includes all such embodiments, changes, and modifications that are encompassed by the scope of the claims.

1a

FIELD OF INVENTION [0001] This invention relates to enclosures for spas. BACKGROUND [0002] Hot tubs are pools designed to hold heated water and are used for soaking, relaxation, massage, or hydrotherapy. Many users of hot tubs have their hot tubs installed at their homes. Naturally, these users seek to have tubs that enhance the aesthetics of the location in which the hot tub is installed. BRIEF DESCRIPTION OF THE DRAWINGS [0003] The above-mentioned features and objects of the present disclosure will become more apparent with reference to the following description taken in conjunction with the accompanying drawings wherein like reference numerals denote like elements and in which: [0004] FIG. 1 is a perspective view of an embodiment of a portable spa enclosure according to the present disclosure; [0005] FIG. 2 is a perspective view of an embodiment of a portable spa enclosure according to the present disclosure; [0006] FIG. 3 is a front view of an embodiment of a corner piece of a portable spa enclosure according to the present disclosure; [0007] FIG. 4 is a bottom view of an embodiment of a corner piece of a portable spa enclosure according to the present disclosure; [0008] FIG. 5 is a top view of an embodiment of a corner piece of a portable spa enclosure according to the present disclosure; [0009] FIG. 6 is a cross sectional view of an embodiment of a corner piece of a portable spa enclosure according to the present disclosure; [0010] FIG. 7 is a perspective view of an embodiment of a portable spa enclosure according to the present disclosure; and [0011] FIG. 8 is a perspective view of an embodiment of a buckle that is used in conjunction with a corner piece of a portable spa enclosure according to the present disclosure. DETAILED DESCRIPTION [0012] An illustrative embodiment of a decorative spa enclosure is shown in FIGS. 1 and 2 . The enclosure 11 includes four side panels 13 , 15 , 17 , 19 . Three of the side panels 15 , 17 , 19 may be identically constructed while side panel 13 is provided with an opening 29 for purposes of installing a spa equipment control panel. [0013] At each of the four corners of the enclosure 11 , respective side panels interface with corner pieces 21 , 23 , 25 , 27 . Each of the corner pieces 21 , 23 , 25 , 27 is preferably a molded plastic part, each having an elongated scallop or depression 31 , 34 , 33 , 32 formed therein. A downlight 36 is located above each scallop or depression 31 , 34 , 33 , 32 so as to illuminate it to provide an aesthetically pleasing appearance at night. [0014] Each of the side panels 13 , 15 , 17 , 19 are preferably formed from a thin, e.g., 0.350 inches thick, plastic sheet, and are supported by respective backing frame structures 57 . The frame structures 57 are shown as comprising a rectangular lattice work in FIGS. 1 and 2 . However, they could be variously configured, as those skilled in the art will appreciate. [0015] The panels 13 , 15 , 17 , 19 and corner pieces 21 , 23 , 25 , 27 are attached to and supported by an internal cabinet structure. The cabinet structure includes lower horizontal frame members 43 , 44 and vertical support members 41 , as well as upper horizontal frame members 45 . The lower horizontal frame support member 44 is fixedly attached to the adjacent horizontal frame member 43 ′ The vertical frame members 41 are fixedly attached to the lower horizontal frame member 44 and to the upper horizontal frame member 45 . Base frame members 56 , 58 are further provided to enhance the rigidity of the structure. The frame and cabinet structures shown may be fabricated from wood, composite, or other suitable materials. [0016] Additionally, bullnoses e.g., 47 , 49 are disposed around the upper periphery of the frame structure. These bullnoses 47 , 49 are provided to support an outer lip of a cooperating spa shell, which preferably conceals them to form a complete spa unit, for example, as illustrated in FIG. 7 . [0017] The construction of one of the corner pieces 25 is illustrated in further detail in FIGS. 3 to 6 . The corner piece 25 is preferably thermo formed from a single ABS plastic sheet using an appropriate mold. The corner piece 25 includes a curved, contoured body portion 75 and a scallop or depression 33 , which includes a smaller depression 73 that provides for installation of a cover buckle 37 provided to facilitate tie-down of a spa cover. The scallop or depression 33 has a generally linear upper edge 78 with respective sides 91 , 93 curving symmetrically toward an end point 95 to create a shield-like shape. [0018] At the lower end of the corner piece 25 is formed a horizontally extending bottom web 79 . The horizontally extending bottom web 79 may include screw recesses 81 , 83 for facilitating attachment to the cabinet structure. In FIGS. 3-6 , dimension W 1 may be, for example, 19.377 inches, while dimension W 2 may be 17.738 inches according to one illustrative embodiment. [0019] Each of the respective side panels 13 , 15 , 17 , 19 includes first and second horizontal grooves 61 , with use of a single groove as illustrated in FIG. 7 being an optional alternative. The side panels are preferably formed of ABS plastic with an acrylic film applied to the front surface thereof. Preferably the plastic and film are extruded together at the same time (“co-extruded”). This process may enable, for example, a decorative wood-grain effect to be obtained. With such a wood grain appearance, the flat plastic panel gives the appearance of wood siding, as illustrated in FIG. 7 . [0020] FIG. 8 illustrates a buckle 37 used for connection of a spa cover, according to embodiments. The buckle may be equipped with a locking mechanism as a safety feature to prevent the spa cover from being removed without the use of a key or combination. [0021] While the apparatus and method have been described in terms of what are presently considered to be the most practical and preferred embodiments, it is to be understood that the disclosure need not be limited to the disclosed embodiments. It is intended to cover various modifications and similar arrangements included within the spirit and scope of the claims, the scope of which should be accorded the broadest interpretation so as to encompass all such modifications and similar structures. The present disclosure includes any and all embodiments of the following claims.

1a

FIELD OF INVENTION [0001] This invention relates to control systems, and in particular, to temperature-controlled actuators. BACKGROUND [0002] In automatic control systems, a temperature sensitive controller is useful for controlling a system based on a change in temperature. . In many controllers, a change in temperature causes a change in some electrical quantity. Examples of such devices include thermistors and resistance temperature detectors (“RTDs”), in which a resistance varies with temperature, and thermocouples, in which a resistance generates a voltage. In such devices, the temperature sensor is placed within the region whose temperatures is to be measured. The sensor generates a signal that can then be transmitted to a switch located outside that region. [0003] Controllers of the foregoing type have two discrete elements: a temperature measurement device to generate a temperature-dependent signal, and a separate electromechanical or electronic actuator for receiving that signal and performing some action on the basis of that signal. As long as an electrical link is provided, the temperature sensor can be separated from the actuator. This is particularly useful when the temperature sensor is to be exposed to a harsh environment. [0004] Another temperature sensitive controller uses a bimetallic strip as a temperatures sensing element. Such controllers are purely mechanical. No electrical signal is needed to drive the actuator because, in effect, the bimetallic strip is both the temperature sensor and the actuator. As the bimetallic strip experiences temperature change, it moves, almost imperceptibly. This temperature-induced motion can be used to, for example, operate a switch. [0005] The bimetallic strip is simple to make and requires no power. In addition, the set point of a control system can easily be adjusted by appropriately biasing the strips. However, a bimetallic strip is unsuited for harsh environments because it is difficult to separate the temperature sensor from the actuator. In addition, it is difficult to accurately control a set point with a bimetallic strip. [0006] Another type of thermally controlled actuator relies on a temperature-dependent phase change or chemical reaction. An example of such an actuator is a spring-loaded element that is held in place by a metal having a melting point lower than that of the spring. When the temperature exceeds the melting point, the metal liquefies, thus releasing the spring-loaded element. Actuators of this type, however, cannot easily be re-used. SUMMARY [0007] The invention is based, in part, on the recognition that a temperature-dependent transition between martensite and austenite states of an alloy can be harnessed to permit a temperature change to trigger mechanical motion. [0008] In one aspect, the invention includes a temperature-controlled actuator having a housing with a proximal end and a moveable distal portion. A core-wire extends along the housing, with its distal section anchored to the distal portion of the housing. The core-wire's distal section has an austenite state and a martensite state. The distal section is configured to move the distal portion of the housing by transitioning between the austenite state and the martensite state in response to a temperature change along a thermometric section of the core-wire. A proximal section in mechanical communication with the core-wire's distal section transmits tension, provided by a tensioning element, to the distal section. The tensioning element, which is coupled to the proximal section of the core-wire, is configured to constantly apply a tensioning force to the core-wire. [0009] In one embodiment, the temperature controlled actuator has a distal section that includes a nickel-titanium alloy. Other embodiments include those in which the housing includes a flexible tube, a tube having a flexible distal portion, or a tube having a hinged distal portion. The housing can be configured to define a path when in a compressed state. The flexible distal portion can be configured to assume a pre-determined shape when relaxed. A proximal portion of the tube can be enclosed by a rigid sleeve. [0010] In another embodiment, the austenite transition temperature of the distal section exceeds an austenite transition temperature of the proximal section. The thermometric section of the core-wire can be the distal section of the core-wire, the proximal section of the core-wire, or an intermediate section of the core-wire. [0011] One embodiment of the actuator includes an intermediate section between the proximal section and the distal section. The intermediate section includes can be an alloy having an austenite state and a martensite state. In this case, the proximal section can be an extension of the intermediate section. This extension has a smaller diameter than the diameter of the intermediate section. [0012] In some embodiments, the proximal section is in an austenite state when the distal section is in a temperature-induced martensite state. In these embodiments, the diameter of the proximal section is selected such that the tensioning force causes the proximal section to be in a stress-induced martensite state when the distal section is in a temperature-induced austenite state. [0013] Conversely, other embodiments include those in which the proximal section is in a temperature-induced martensite state when the distal section is in an austenite state. In these embodiments, the diameter of the distal section is selected such that the tensioning force causes the distal section to be in a stress-induced martensite state when the proximal section is in a temperature-induced austenite state. [0014] The tensioning element can apply a constant force or a variable force. Examples of tensioning elements include a mass suspended from the core-wire, an axially moveable member engaging the core-wire, the axial position of which controls the tension in the core-wire, a spring loaded plate pushing against the core wire, or a screw applying tension to the core wire. [0015] Another aspect of the invention is a method for providing a mechanical response to a temperature change in a monitored environment. The method includes anchoring a distal section of a core-wire to a distal portion of a housing. The distal section has an austenite state and a martensite state. The core-wire is then biased with a tensile force. A thermometric portion of the core-wire is then exposed to the monitored environment. [0016] In one practice, exposing a thermometric portion of the core-wire includes exposing the distal section of the core-wire to the monitored environment. This practice of the invention can include causing a transition between an austenite state and a martensite state in the distal section in response to a temperature change along the distal section. [0017] Alternatively, exposing a thermometric portion of the core-wire includes exposing the proximal section of the core-wire to the monitored environment. This alternative practice of the invention can include causing a transition between an austenite state and a martensite state in the proximal section in response to a temperature change along the proximal section. In response to this transition, the method optionally includes causing a transition between an austenite state and a martensite state in the distal section in response to the transition between an austenite state and a martensite state in the proximal section. [0018] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, suitable methods and materials are described below. All publications, patent applications, patents, and other references mentioned herein are incorporated by reference in their entirety. In case of conflict, the present specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting. [0019] The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the invention will be apparent from the description and drawings, and from the claims. BRIEF DESCRIPTION OF THE DRAWINGS [0020] Like reference symbols in the various drawings indicate like elements. [0021] FIG. 1 is a schematic of an actuator in its relaxed state. [0022] FIG. 2 is a schematic of the actuator of FIG. 1 in its tensioned state. [0023] FIG. 3 is a cross-section of the actuator of FIG. 1 in its relaxed state. [0024] FIG. 4 is a cross-section of the actuator of FIG. 1 in its tensioned state. [0025] FIG. 5 is cross-sections of a second actuator in its relaxed state. [0026] FIG. 6 is a cross-section of the actuator in FIG. 5 in its tensioned state. [0027] FIG. 7 is a cross-section of a third actuator in its relaxed state. [0028] FIG. 8 is a cross-section of the actuator in FIG. 5 in its tensioned state. DETAILED DESCRIPTION [0029] Temperature-controlled actuators described herein use an inhomogeneous core-wire that, when subjected to a pulling force, stretches by different amounts at different locations. These different amounts depend, in part, on temperatures at various sections of the core-wire. At least one portion of the core-wire includes a shaped memory alloy that has been pre-heated to take a pre-defined shape when in its austenite state. This portion of the wire is attached to and controls the shape of a flexible portion of the actuator. A weight or other force applicator coupled to the proximal section of the core-wire maintains tension along the core-wire. [0030] Referring to FIG. 1 , a first embodiment of an actuator 10 incorporating the principles of the invention includes a housing 12 having a proximal portion and a distal portion. In the illustrated embodiment, the housing 12 is a flexible tube made of articulating segments. However, the housing 12 can also be a tube having a flexible distal portion and a rigid proximal portion. A housing 12 has an equilibrium compressed state in which it defines a pre-selected path. Additionally, the housing 12 can be a tube having a rigid distal portion coupled to a rigid proximal portion by one or more hinges to allow movement of the distal portion relative to the proximal portion. In other embodiments, the housing 12 need not be tubular at all, but can instead be open to its surroundings. [0031] A sleeve 14 enclosing the proximal portion of the housing 12 provides rigid support to the proximal portion. The distal portion of the housing 12 , however, is free to change its shape. In particular, the distal portion is free to change between a relaxed shape, shown in FIG. 1 , and a tensioned shape, shown in FIG. 2 . In FIGS. 1 and 2 , the relaxed shape is a coil and the tensioned shape is straight. However, the invention is not constrained to these two particular configurations. [0032] As indicated by FIG. 1 , the housing 12 can be a segmented structure capable of articulation between its constituent segments. However, the housing 12 can also be any flexible section capable of freely making the required transition between the curved state of FIG. 2 and the extended state of FIG. 1 . The housing 12 may be a close wound coil, with or without preload, or it may be an open wound coil. The housing 12 can include baffles, bellows, or any such flexible and compressible member. [0033] A cross-sectional view of the actuator 10 , shown in FIGS. 3 and 4 , reveals a portion of the structure that enables a change in temperature to toggle the housing 12 between its relaxed state and its tensioned state. [0034] Referring to FIG. 3 , a core-wire 16 anchored at an end cap 19 at the distal end of the housing 12 extends through a lumen between the distal and proximal ends thereof. The end cap 19 provides mechanical coupling between the core-wire 16 and the housing 12 so that a change in the path traced out by the core-wire 16 results in a corresponding change in the path traced out by the housing 12 . [0035] Coupling between the housing 12 and the core-wire 16 can also be provided by a direct connection between the housing 12 and the core-wire 16 . In addition, the point of coupling need not be at the tip of the housing 12 as shown in FIG. 3 . By proximally displacing the coupling point, for example, the tip can be made floppy. [0036] A proximal end of the wire 16 is operably connected to a tensioning element 20 that applies a constant force, denoted by the force vector {right arrow over (F)}, to the proximal end of the core-wire 16 . Because the core-wire 16 is anchored to the end cap 19 , this constant force does not move the core-wire 16 . Instead, it places the wire 16 under tension. This tension is manifested as a stress field throughout the core-wire 16 . In response to the stress field, the core-wire 16 stretches. The design of the core-wire 16 is such that at a particular temperature, different portions of the core-wire 16 stretch by different amounts. [0037] The tensioning element 20 is represented in FIG. 3 as a weight. However, any mechanism for applying a force can be used as a tensioning element 20 . For example, a pulley may be used to direct the force at an angle relative to the force vector. The magnitude of the force need not be constant. In other embodiments, the weight can be replaced by a spring mechanism. [0038] A distal section 22 of the core-wire 16 is made from a shaped-memory alloy. A suitable alloy from which the core-wire 16 can be manufactured is a nickel-titanium alloy sold under the trade name NITINOL™. Such an alloy has the property that when deformed and heated past a critical temperature, which is on the order of 700 degrees Fahrenheit for NITINOL, it “remembers” its deformed shape. [0039] A distal section 22 is formed by deforming a distal section of the core-wire 16 , heating it past a critical temperature, and then cooling it. The shape into which the distal section 22 is deformed then becomes the remembered shape. When treated in this manner, the distal section 22 acquires temperature-dependent mechanical properties. In particular, the distal section 22 has the property that it can be in one of two states: an austenite state, in which it reverts to its remembered shape, and a martensite state, in which it is super-elastic. [0040] The state in which the distal section 22 of the core-wire 16 finds itself depends on its temperature. When heated past an austenite transformation temperature, the distal section 22 reverts to its austenite state. In this state, the distal section 22 has a tendency to recover its remembered shape. In addition, when the distal section 22 is stressed, it yields reluctantly. An applied stress on the distal section 22 in its austenite state results in comparatively little elongation of that section. In contrast, when cooled below a martensite transformation temperature, the distal section 22 becomes super-elastic. In its martensite state, the distal section 22 yields readily. Thus, an applied stress results in considerable strain, and hence considerable elongation of the distal section 22 . [0041] A proximal section 24 of the core-wire 16 is made of a rigid material, for example stainless steel, whose strain response is only weakly dependent on temperature. Alternatively, the proximal section 24 can be made of a super-elastic alloy having an austenite transformation temperature that is less than the austenite transformation temperature of the distal section 22 . [0042] In operation, the force applied by the tensioning element 20 urges the core-wire 16 to stretch. When the distal section 22 of the core-wire 16 is below its martensite transformation temperature, the distal section 22 loses its tendency to assume its remembered shape. In addition, the distal section 22 becomes super-elastic. As a result, most of this stretching occurs at the distal section 22 . The proximal section 24 , being more rigid than the super-elastic distal section 22 , stretches very little. Because the distal end of the core-wire 16 is anchored to the end cap 19 , there is a tendency for the core-wire 16 to straighten the distal section of the housing 12 , as shown in FIG. 4 . [0043] In contrast, when the distal section 22 of the core-wire 16 is above its austenite transformation temperature, it loses its super-elastic properties and assumes its remembered shape. As a result, it stretches very little. In this case, what stretching occurs is borne by the proximal section 24 . In addition, the distal section 22 reverts to its remembered shape. Because the core-wire 16 is mechanically coupled to the housing 12 by the end cap 19 , the distal section of the housing 12 likewise assumes this remembered shape. [0044] As noted above, a material such as NITINOL becomes super-elastic when it transitions from its austenite form to its martensite form. This can occur when the NITINOL, in its austenite form, is cooled to below its martensite transition temperature. Another way to cause a transition from austenite to martensite, however, is to pull so hard on an austenite wire that it turns into martensite. Martensite formed in this way is referred to as “stress-induced martensite”. Additional embodiments of the invention, described below, make use of stress-induced martensite. [0045] In a second embodiment, shown in FIGS. 5 and 6 , the core-wire 16 has a distal section 22 , a proximal section 24 , and an intermediate section 26 between the distal and proximal sections 22 , 24 . The distal section 22 and the intermediate section 26 are similar to the distal section 22 and proximal section 24 described above in connection with the first embodiment. [0046] As was the case with the first embodiment, a tensioning element 20 coupled to the proximal end applies a constant force that places the core-wire 16 in tension. The resulting tension causes a stress field throughout the core-wire 16 , including within its proximal section 24 . The strain experienced by the proximal section 24 in response to that stress depends in part on whether the distal section 22 is in its austenite state or in its martensite state. [0047] Referring to FIG. 5 , when the distal section 22 is below its martensite transition temperature, it becomes super-elastic. As a result, most of the stress imposed by the tensioning element 20 is relieved by the stretching of the distal section 22 . Because the stress is relieved primarily by stretching of the distal section 22 , the proximal section 24 undergoes comparatively little strain. As a result, the proximal section 24 remains in its austenite form. [0048] Referring now to FIG. 6 , when the distal section 22 is above its austenite transition temperature, it loses its super-elastic properties and reverts to its remembered shape. As a result, the distal section 22 no longer contributes so generously toward relieving the stress present throughout the core-wire 16 . In this case, the stress strains the proximal section 24 and thereby causes it to transition into its martensite form. Once in its martensite form, the proximal section 24 becomes super-elastic. In its super-elastic form, the proximal section 24 stretches sufficiently to relieve the stress in the core-wire 16 . [0049] The proximal section 24 and the intermediate section 26 can be different materials. However, to avoid having to join the proximal and middle sections, it is convenient to make them integral with each other. In the illustrated second embodiment, the proximal section 24 is formed by grinding down a section of the core-wire 16 . In this case, the proximal section 24 is that portion of the wire 16 whose diameter has been reduced by grinding and the intermediate section 26 is that portion of the wire 16 that retains its original diameter. Because the proximal section 24 has a smaller diameter than the intermediate section 26 , it yields more to stress than does the intermediate section 26 . This, in turn, ensures that the intermediate section 26 can remain in its austenite form even when the proximal section 24 has transitioned into its martensite form. [0050] In a third embodiment, shown in FIGS. 7 and 8 , the roles of the proximal and distal sections of the core-wire 16 are opposite those in the second embodiment. In this case, a NITINOL core-wire 16 has a reduced-diameter distal section 22 . As a result, the distal end responds to sufficient stress by transitioning into stress induced martensite. In so doing, it acquires super-elastic properties and stretches as shown in FIG. 7 . Because the core-wire 16 is coupled to the housing 12 by the end cap 19 , this causes the housing 12 to straighten. In the absence of such stress, the distal end reverts to austenite and recovers a remembered shape. Again, because the core-wire 16 is coupled to the housing 12 by the end cap 19 , this causes the housing 12 to assume that remembered shape. [0051] The proximal section 24 of the core-wire 16 has an austenite transition temperature that is higher than the austenite transition temperature of the intermediate section 26 of the core-wire 16 . As was the case with the second embodiment, a tensioning element 20 applies a pulling force to the proximal end. [0052] Referring to FIG. 8 , when the proximal end of the core-wire 16 is below its martensite transition temperature, it becomes martensite. As a result, it stretches considerably, so much so that it manages to relieve most of the stress applied throughout the core-wire 16 . The proximal section 24 thus isolates the distal section 22 from stress sufficient to turn it into stress induced martensite. Because the distal section 22 remains austenite, it assumes its remembered shape. Because of the coupling between the core-wire 16 and the housing 12 , the housing 12 likewise assumes the remembered shape. [0053] Referring to FIG. 7 , when the proximal section 24 is above its austenite transition temperature, it becomes austenite, and therefore does not stretch significantly in response to the applied stress. As a result, the stress must be borne by the remainder of the core-wire 16 . Because of its reduced diameter, the distal section 22 of the core-wire 16 experiences considerable stress, enough to cause it to transition into stress-induced martensite. In doing so, it loses its remembered shape and straightens. Because of the coupling between the core-wire 16 and the housing 12 , the housing 12 also straightens. [0054] The tensioning element 20 shown in FIGS. 6-8 is a collar having a slot for accepting the sleeve 14 and a central opening for attachment to the core-wire 16 . The slot enables the tensioning element 20 to move axially along the sleeve 14 , thereby changing the tension applied to the core-wire 16 . The axial position of the slot can be adjusted by, for example, by a rack and pinion arrangement. However, no particular form of tensioning element 20 is required. What is important is that the core-wire 16 be constantly sufficient tension to stretch a portion of the core-wire when the temperature provides an opportunity to do so. [0055] Another embodiment of a tensioning element 20 is a screw that mounted across the diameter of the housing. The screw has a hole in its shaft that engages the core-wire 16 . As the screw turns, the core-sire 16 can be tightened or loosened in the same manner that a string is tuned on a guitar or other stringed instrument. [0056] The austenite transformation temperature and the martensite transformation temperature can be adjusted by known methods such as heat treating the alloy or doping the alloy. OTHER EMBODIMENTS [0057] It is to be understood that while the invention has been described in conjunction with the detailed description thereof, the foregoing description is intended to illustrate and not limit the scope of the invention, which is defined by the scope of the appended claims. Other aspects, advantages, and modifications are within the scope of the following claims.

1a

BACKGROUND OF THE INVENTION This invention relates to a target projector such as might be used, for example, in automatically testing one's visual field. Measurement of one's visual field is important for a variety of reasons including the diagnosis of glaucoma as well as other human visual system diseases or impairments. In general, the prior techniques for determining one's visual field and any blind spots have been quite slow and tedious and require a definite subjective response from the person being tested in order to determine whether he has sighted the target at a particular location in his visual field. Additionally, the previously employed tests require administration by one having relatively high degree of skill such as an ophthalmic technician, optometrist or ophthalmologist. For example, in the most common type of visual field test, a hand-held target such as a small disc at the end of a wand, is moved about the subject's visual field by the examiner while the subject fixates on a central point. During movement of the hand-held target through the subject's field, the examiner asks the subject repeatedly whether he can see the movable target as it is passing from location to location. The examiner may plot, manually, the location of each point which is seen by the subject, or alternatively, he may plot those locations which the subject is unable to see, and which, therefore, define his blind spot. In order to overcome the uncertainties and difficulties in the foregoing prior testing techniques improved techniques have been developed to automate the foregoing visual field test and to obtain an objective evaluation of the subject's visual field. By way of example, an improved method and apparatus is described in U.S. Pat. application Ser. No. 286,422, filed Sept. 15, 1972. The technique includes a means for projecting, automatically, and in sequence, a plurality of target images to the subject in selected, various locations within his visual field. SUMMARY OF THE INVENTION My invention relates to an improved target image projector usable, for example, in a system of the type described above. The target image projector includes a projection light source which develops a narrow collimated light beam. The position of the light beam and target image on the screen is determined by reflecting the beam, from its source, off one surface of a double faced mirror toward the screen. The attitude of the mirror is controllable to selectively direct the beam in the desired direction by stepping motors which may be positioned in accordance with preprogrammed digital information. The location of the target image on the screen, as presented to the subject, may be recorded permanently and automatically on photographic film incorporated into the projector. The photographic recording is made by employing a second light beam which is reflected off the opposite face of the controlled mirror toward the photograph film. The second, reflected beam is directed along the same axis as the first projection beam, but from the opposite direction and impinges on the film at a location which is dependent on the angle of incidence of the beam to the mirror which corresponds to the direction of the light beam which impinges on the target screen. Shutters are provided in association with each of the first and second light beams, the first shutter being employed to control the timing and duration of presentation of the target light and the second shutter means being employed to expose the photographic film to the second beam. The mirror is mounted for rotational movement about each of a pair of perpendicular axes and one stepping motor is associated with each of the axes to rotate the mirror in incremental steps about its respective axes. It is among the primary objects of the invention to provide an improved target image projector. Also among the objects of the invention is to provide a light beam projector which is readily usable in a system for presenting target images at predetermined locations in accordance with preprogrammed digital information. A further object of the invention is to provide a projector of the type described which is of simple construction and is compact. DESCRIPTION OF THE DRAWINGS The foregoing and other objects and advantages of the invention will be understood more fully from the following further description thereof, with reference to the accompanying drawings wherein: FIG. 1 is an illustration of a system in which the invention may be employed; FIG. 2 is a sectional plan illustration of the mirror positioning mechanism as seen from line 2--2 of FIG. 1 and showing portions of the mechanism broken away; FIG. 3 is a diagrammatic sectional elevation as seen along the line 3--3 of FIG. 2; FIG. 4 is a side elevation of the mirror positioning mechanism as seen along the line 4--4 of FIG. 2; FIG. 5 is a sectional view of the mirror positioning mechanism as seen along the line 5--5 of FIG. 4; FIG. 6 is a sectional elevation of the mirror positioning mechanism as seen along the line 6--6 of FIG. 5; and FIG. 7 is an enlarged illustration of the low friction bearing by which the mirror is mounted. DESCRIPTION OF THE PREFERRED EMBODIMENT FIGS. 1-3 shows generally a visual fields testing system including a projector-camera housing 10 in which is mounted the mirror mechanism 12. The housing 10 includes a front wall 14 and a rear wall 16, having apertures 18, 20 respectively which can be opened or closed by a projection shutter indicated diagrammatically at 22 and film shutter indicated diagrammatically at 24. The mirror mechanism 12 includes a double faced mirror 26 having a front face 28 and a rear face 30. The mirror 26 is arranged so that it will reflect a collimated light beam 32 from a projection light 34, mounted to a sidewall 36 of the housing 10 through the projection shutter 22 and onto the projection screen 38. The opposite sidewall 40 of the housing 10 supports a second light source 42 which directs a beam of light 44 toward the rear face 30 of the mirror 26 along the same axis as that of the light beam from the projection light 34. The beam from the recording light source 42 is reflected from the mirror surface 30 in a direction which is opposite that of the reflected projection beam 32 from the front face 28 of the mirror 26. The recording light beam 44 is directed toward a film plane, indicated diagrammatically at 46 and disposed at the rear of the housing 10 by any of a variety of well-known film holding devices 48. The double faced mirror 26 thus directs the projection beam 32 to a selected location on the screen and simultaneously directs the recording beam 44 to a corresponding location in the film plane 46, depending on the attitude of the mirror 26. The mirror 26 is mounted for adjustable movement by the mirror mechanism 12 in which the mirror 26 is rotatable about each of a pair of perpendicular axes. The mirror mechanism includes a support block 50 which is secured to the interior of the housing 10. The mirror mechanism 12 includes a driven bevel gear segment 52. The mirror 26 is secured with respect to and across the diameter of gear 52 by a bracket 54 and lies in a plane perpendicular to that of the gear 52 and which coincides with the axis of rotation of the gear 52. The mirror 26 and gear 52 are supported for rotation in unison about the rotational axis of the gear 52 by means of a yoke 56 having low friction bearings 58, 60 which support the upper edge of the mirror, by bracket 62, and the opposite face of the gear 52, by bracket 54, to enable the mirror 26 and gear 52 to rotate in unison about the common axis defined by the bearings 58, 60. The yoke 56 is mounted for rotation about a horizontal axis perpendicular to the axis defined by bearings 58, 60 to rotate the mirror 26 and gear 52 bodily about that horizontal axis. To this end the yoke 56 is secured to the end of an outer cylinder 64 which is rotatably mounted within a cylindrical cut-out 61 formed along one side of the block 50 as by ball bearings 63 which are securely mounted to the cut-out 61. The cylinder 64 has a worm gear 66 secured thereto which is driven by a worm 68 which is driven, in turn, by a stepping motor 80 mounted to the block 50. The worm 68 is disposed within a bore 69 formed in the block 50 and may be supported by bearings 71. The mirror 26 and gear 52 are driven with respect to the yoke 56 by means of an inner cylinder 72 which extends through the outer cylinder 64. An end of the inner cylinder 72 extends into and is journaled to the yoke at bearing 73. The other end of the inner cylinder 72 extends rearwardly beyond the end of the outer cylinder 64. The rear, protruding end of cylinder 72 has a collar 75 secured thereto and the collar 75 is rotatably mounted within cut-out 61 of the block 50 by bearing 77. A bevel gear 74 is secured to the end of the inner cylinder 72 which projects into the yoke 56 and meshes with the driven beveled gear 52 to which the mirror is mounted. The inner cylinder 72 is rotated by means of a worm gear 76 secured to the collar 75. Gear 76 is driven by a worm connected to the drive shaft 78 of stepping motor 70 in the same manner as described above with regard to worm 68. The stepping motors 70, 80 are operated in response to appropriate electrical signals from the controlling electronic circuitry to pulse the motors incrementally to their intended positions. The motors 70, 80 may be selected from a wide variety of commercially available devices and preferably are reversible. The recording light 42 is mounted in the housing and extends into the rearward end of the cut-off 61 in the block in alignment with the axis of rotation of the cylinders 64, 72. The recording light thus passes axially through the hollow inner cylinder 72 and, if desired, suitable lenses, such as suggested at 79 may be mounted within the hollow inner cylinder 72 to maintain the light beam collimated. The projection light source 34 is mounted to the opposite side wall of the housing, also in substantial alignment with the axis of rotation of the cylinders so that both light beams will be directed substantially along the same horizontal axis and will be reflected in substantially opposite directions. It may be noted that the axis of rotation of the mirror defined by the bearing 58, 60 is a movable axis in that it intersects, perpendicularly, and is rotatably about the horizontal axis of the cylinders 64, 72. It may be noted further that operation of one of the step motors 70, 80 usually will result in movement of the mirror in a compound direction, e.g., rotation of the yoke alone usually will also cause some rotation of the mirror about the axis defined by its bearings 58, 60. When such compound motion is not desired, it may be corrected by operating the other of the stepper motors in a reverse direction to compensate and drive the inner cylinder to return the mirror to its desired position about the movable axes. This may be accomplished by suitable electronic control of the stepping motors 70, 80 and reference is made to an application of Marvin E. Jernigan filed of even date herewith for a description of one such control system. Similarly, the operation of the projection and recording lights as well as the projection and recording shutters may be controlled electronically as described in said application. The invention is illustrated as being employed in connection with a visual fields testing system which may also include a partially reflective plate 82 mounted above and forwardly of the housing 10 so as to be directly in front of the subject's view when his head is properly placed in the head rest and chin support 84. Plate 82 is adapted to enable the subject to view the screen 38 and is disposed at an angle to his general line of sight to enable a light source 86, preferably infrared, to reflect from the plate 82 and illuminate the subject's eyes. The image from the subject's eyes is, in turn, reflected from the plate 82 toward an imaging arrangement 88 which includes a ground glass screen 90 on which the reflected image of the subject's eye may be focused, employing the technique described in the aforementioned U.S. patent. As described in that patent a pair of vertically spaced photoelectric cells 92 and horizontally spaced photoelectric cells 94 are located on or adjacent the screen 90 and are aligned with selected regions of the image of the subject's eye on the screen 90. Variations in the output signals from the photocells 92, 94 are dependent on the direction and magnitude of the subject's eye movements and their signals may be electronically processed. Imaging arrangement 88 preferably is mounted for adjustment to the housing 10 to facilitate initial alignment of the photocells 92, 94 with the subject's eye image on the screen 90. This may include a bracket 96 pivoted for horizontal movement to the housing 10 and a vertical elevation screw 98 carried by the bracket 96 and in engagement with the end of the barrel 100, the other end of the barrel 100 being pivoted to the bracket at trunnions 102. While the invention has been described primarily for use in a visual fields testing system, it may be employed in other environments where it is desirable to control the direction of a beam of light. It should be understood that the foregoing description of the invention is intended merely to be illustrative thereof and that other modifications and embodiments may be apparent to those skilled in the art without departing from its spirit.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention generally relates to a chili harvester in the form of a self propelled vehicle for movement along rows of chili pepper plants and includes spaced, opposed rotatably driven picking units. Each of the picking units is in the form of a plurality of vertically oriented spirally coiled pod picking rods. The spirally coiled rods are supported for lateral adjustment in relation to each other for varying the distance between opposed spirally coiled rods for optimizing the picking efficiency of the picking units and enabling the picking units to be adjusted to compensate for variations in picking conditions. The spirally coiled picking units are manually adjusted towards and away from each other to vary the spatial relation between the picking units. A paddle-type conveyor structure is associated with each picking unit for conveying chili pods removed from the chili plants rearwardly and upwardly onto a transverse conveyor which drops chili pods through an air gap onto a rearwardly and upwardly extending conveyor with pressurized air passing through the air gap to remove lightweight trash, debris and the like from the chili pods. 2. Description of the Prior Art My prior U.S. Pat. Nos. 4,546,602 issued Oct. 15, 1985 and 5,210,999 issued May 18, 1993 disclose chili pepper harvesters with forwardly extending picking units combined with conveyor structures to collect the chili pods removed from the plants by the picking units and conveying the chili pods through a trash separation unit and sorting unit. U.S. Pat. No. 3,568,419 issued Mar. 9, 1971 discloses a chili harvester picking unit in the form of opposed rotatably driven spiral coils. The above patents and the prior art of record therein are incorporated herein by reference thereto. The prior patents do not disclose a chili harvester incorporating the novel and unique features of the chili harvester disclosed in this application. SUMMARY OF THE INVENTION An object of the present invention is to provide a chili harvester having multiple picking units extending forwardly therefrom with each picking unit including a plurality of spaced and opposed spiral picking coils formed by a spiral rod that has its upper and lower ends laterally adjustably supported to enable opposed spiral coils to be adjusted toward and away from each other for more effective removal of chili pepper pods from chili pepper plants. Another object of the invention is to provide a chili pepper harvester in accordance with the preceding object in which the opposed picking coils in each picking unit are counterrotated for more effective removal of chili pepper pods from the plants. A further object of the invention is to provide a chili pepper harvester in accordance with the preceding objects in which each spiral picking coil includes a central shaft having supporting bearings individually adjustably mounted on top and bottom plates with the top and bottom plates being manually adjusted to move all of the spiral picking coils on one side of a picking unit laterally in relation to the coils on the other side of a picking unit to vary the space between the picking units through which chili pepper plants pass for optimizing the picking efficiency of the picker units. Still another feature of the chili harvester is the use of paddle conveyors for conveying the harvested chili pods rearwardly and upwardly for depositing on a transverse conveyor which drops the chili pods through an air gap onto a rearwardly and upwardly extending conveyor with the air gap being subjected to an air flow therethrough for entraining and removing trash and debris which may have been picked by the picking units with the air gap including vertically adjustable fingers on the downstream side of the air flow passing through the air gap to collect any chili pods which may have been entrained in the air flow. Another significant object of the invention is to provide a chili harvester in accordance with the preceding objects in which each picking unit is provided with a floating leaf lifter at the forward end thereof for lifting the chili pepper plant leaves for entry between the picker units. These together with other objects and advantages which will become subsequently apparent reside in the details of construction and operation as more fully hereinafter described and claimed, reference being had to the accompanying drawings forming a part hereof, wherein like numerals refer to like parts throughout. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of the forward end portion of a chili pepper harvester illustrating the picker units extending forwardly from a self propelled vehicle. FIG. 2 is a side elevational view of the structure illustrated in FIG. 1. FIG. 3 is a longitudinal, vertical sectional view taken substantially upon a plane passing along section line 3--3 on FIG. 1 illustrating structural details of the picker unit and conveyor. FIG. 4 is a top plan view of one of the picker units illustrating the drive structure for the spiral coils. FIG. 5 is a plan sectional view substantially along section line 5--5 on FIG. 3 illustrating the mounting plates and mounting structure for the lower ends of the spiral coils. FIG. 6 is a transverse sectional view taken substantially along section line 6--6 on FIG. 3 illustrating further structural details of the picker unit. FIG. 7 is a transverse sectional view taken substantially along section line 7--7 on FIG. 3 illustrating the structure of the transverse conveyor, the air gap at the discharge end of the transverse conveyor and the finger structure spaced from the discharge end of the transverse conveyor to limit outward movement of material discharged on an upwardly inclined conveyor. FIG. 8 is a detailed fragmental sectional view taken along section line 8--8 on FIG. 4 illustrating the structure for adjusting the spiral picker coils. FIG. 9 is a fragmental prospective view illustrating the lower end of the structure for adjusting the spiral coils. FIG. 10 is a sectional view taken substantially along section line 10--10 on FIG. 6 illustrating further structural details of the fingers which retain the chili pods discharged from the transverse conveyor and which may be picked up by the air flow as they pass through the air gap. FIG. 11 is a perspective view of the mounting plate for each end of the spiral coils to enable adjustment of the coils individually or simultaneous with respect to the coils on the other side of a picking unit. DESCRIPTION OF THE PREFERRED EMBODIMENT The chili pepper harvester of the present invention is partially illustrated in FIGS. 1 and 2 and is designated by reference numeral 12. The rearward portion of the chili pepper harvester is the same as that disclosed in my U.S. Pat. No. 5,210,999. The chili pepper harvester 12 is in the form of a mobile vehicle including support wheels 14 and an operator's cab 16 in which controls are provided for operating the harvester. Projecting forwardly from the harvester is a pair of picker units 18 for straddling and removing chili pepper pods from two rows of chili pepper plants. The number of picker units 18 may vary and are of identical construction. The picker units may be angulated upwardly or oriented generally horizontally by frame structure and hydraulic lifting rams oriented in a manner to position the picker units 18 in generally horizontal relation adjacent to but above the ground surface. Each picker unit 18 includes opposed rows of spiral picking coils 20 as illustrated in FIGS. 4 and 5. FIG. 3 illustrates four vertically disposed spiral coils 20 in each row of picking units with the rows of picking units being disposed along opposite sides of the picker unit 18 to receive the chili pepper plants therebetween as the picker unit 18 moves forwardly as illustrated by the arrow in FIG. 5. Each spiral coil 20 is in the form of a spiral rod having a radially inwardly extending end portion 22 rigidly affixed to a central vertical shaft 24 as illustrated in FIGS. 3, 5 and 6. Each picker unit 18 includes an outer vertical frame 26 supporting outer side walls 28 in the form of wire mesh or reticulated material forming a closure for the outer walls of the picker unit 18. The bottom of the picker unit 18 is provided with an inwardly extending bottom member 30 supported from the frame 26 and including an upwardly offset bottom member 32 at the inner edge of bottom member 30 to form a support for the lower ends of the shafts 24 of the coils 20 as illustrated in FIG. 6. The inner edge of the upwardly offset wall portion 32 is provided with an inclined plate 34 which inclines upwardly and inwardly. The inclined plate 34 is adjustably secured in lateral adjusted relation by fasteners 36 extending through slots to enable the plates 34 to be adjusted toward and away from each other to provide a slot-like passageway 38 for the stalks of the chili pepper plants passing through the picker units 18. As illustrated in FIG. 6, the spiral coils 20 are spaced apart a distance generally equal to the width of the passageway 38. Positioned on the bottom wall 32 is a mounting plate 40 for bearing 42 which support the lower end of the shaft 24. The top of the picker unit 18 is provided with a top wall 44 which supports a mounting plate 46 for the upper ends of the shafts 24 which are journaled in bearings 48 supported from the mounting plate 46. FIG. 11 illustrates the structure of the mounting plate 40 which includes a plurality of lateral slots 50 extending inwardly from one edge of the elongated plate 40. The end edges of the plate 40 includes an inwardly extending slot or notch 52 and the corner edges of the plate 40, opposite to the slots 50 are notched or recessed at 54 and the notched corners 54 face inwardly as illustrated in FIG. 5. The upper plate 46 is of similar structure. The slots 50 receive mounting bolts 56 to attach the bearing 42 to the plate 40. This enables each individual bearing 42 at the lower end of the shaft 24 to be adjusted laterally in relation to the plate 40 and locked in place by use of the bolts 56. The upper end of the shaft 24 is individually adjustable in the same manner in order for the bearings on each shaft 24 to be simultaneously adjusted and locked in place in relation to the lower mounting plate 40 or the upper mounting plate 46. Each of the top and bottom mounting plates are movable laterally inwardly or outwardly as indicated by the arrows in FIG. 5 to move all of the coils 20 toward or away from each other. The structure for moving the plates 40 and 46 inwardly and outwardly is an elongated vertically disposed shaft 58 at each end of the plates 40 and 46 with the shafts being journaled in bearing sleeves 60 attached in vertical alignment to an end wall structure 62. The lower end of the shaft 58 is provided with an offset eccentric rod 64 received in the notch 52 in the plate 40. The upper end of each shaft 58 is provided with a similar eccentric rod 66 received in the notch in the end of the plate 46. At the upper end of the shaft 58, a portion of the shaft is broken away at 68 with the spaced portions being connected by a connector 70 which enables the plate 46 to move laterally inwardly and outwardly through the space 68. The upper end of the shaft 58 is provided with a laterally extending handle 72 pivoted to the upper end of the shaft by a pivot member 74 to enable the handle 72 to pivot from a generally horizontal position parallel to the plate 46 to an upwardly inclined or upwardly extending position as illustrated by broken line in FIG. 8. With this structure, the handle 72 can be moved in a rotatable path when it is in an inclined position thus rotating the shaft 58 so that the eccentrics 64 and 66 will move the upper and lower plates 40 and 46 inwardly in unison thus moving all of the spiral coils 20 on each side of the picker unit 18 toward and away from each other simultaneously. In order to lock the shaft 58 in adjusted position, an arcuate flange 76 is mounted on an end frame member 78. The arcuate flange has a center corresponding with the center of rotation of the shaft 58 and is provided with a plurality of vertical notches 80 therein to receive the lower edge portion of the handle 72 when in a generally horizontal position as illustrated in FIG. 8 thus locking the handle 72 against rotational movement thereby locking the shaft 58 and thus the upper and lower plates 40 and 46 in laterally adjusted relation. FIG. 5 illustrates the movement of the plates and the inwardly adjusted and outwardly adjusted position of the spiral coils as indicated by broken lines. Thus, the space between opposed spiral coils may be adjusted depending upon the conditions encountered when harvesting chili peppers. As illustrated in FIGS. 4 and 6, each of the shafts 24 having the spiral coils 20 mounted thereon extend upwardly beyond the upper bearings 48 and each shaft includes a sprocket gear 82 thereon for engagement by a continuous sprocket chain 84 which is entrained over a drive sprocket gear 86 at an inner end of the picker unit 18 and entrained over an idler sprocket gear 88 at the forward end of the picker unit 18 and intermediate sprocket gears 90 between certain of the sprocket gears 82. With the endless construction of the sprocket chain 84 and the association of the sprocket gears with the drive chain 84, the coils on one side of the picking unit 18 rotate in one direction and the spiral coils on the other side rotate in the opposite direction with the coils rotating in a direction to engage the chili pepper plants in a manner to move the leaves and chili pepper pods upwardly for separating the pods from the chili pepper plants and depositing the chili pods laterally outwardly of the rotating spiral coils. The idler sprocket 88 is located generally in alignment with one row of spiral coils and the idler sprocket gears 90 are oriented between the coils nearest the drive sprocket gear 86. The idler gears 88 and 90 are supported from a bracket structure 92 having slots 94 therein to receive the shaft and fastening arrangement to adjustably support the sprocket gears to enable the drive chain 84 to be kept in a taut condition even though the spiral coils 20 may be adjusted laterally in relation to each other. As a safety measure, all of the sprocket gears, the sprocket chain and other structure at the upper end of the picker unit are enclosed by a heavy screen, expanded metal or reticulated material 96 rigidly affixed to the top of the picker unit or the reticulated material may be removably attached to provide access to the sprocket gears and chain for repair, lubrication and the like. Positioned alongside of and outwardly from the bottom of the spiral coils 20 is a plurality of paddles 98 which are movable along the upper surface of the bottom wall or member 30. The outer frame 26 is in the form of an inwardly facing channel shaped member receiving an endless sprocket chain 100 to which one end of the paddles 98 are attached. The paddles 98 extend along the surface of the bottom wall 30 and also extend along the upper surface of an inclined extension 102 of the bottom wall 30 which extends upwardly to a point overlying a transverse conveyor generally designated by reference numeral 104. As shown in FIG. 3, the upper end of the wall 102 curves outwardly and downwardly at 106 over a side wall 108 of the conveyor 104 to deposit all material removed from the chili pepper plants onto the conveyor 104. The sprocket chain 100 extends over a drive sprocket gear 110 and extends downwardly along the inner surface of a downwardly inclined front wall 112 which joins with the top wall 44 of the picker unit 18. At the forward top of the picker unit 18, the chain 100 extends downwardly against the inner surface of a front wall 114 to the lower front corner of the picker unit and then rearwardly in channel shaped member 26 along the inner surface of the bottom wall 30 as illustrated in FIG. 3. A lubricator 101 is provided for each sprocket chain 100 which is oriented at the rearward end of the top wall 44 and includes a brush 103 engaging the top surface of the chain 100 and a supply line 105 provides pressurized lubricant to the lubricator 101. A control in the cab is used to operate the lubricator. With this construction, the material discharged laterally from the rotating spiral coils will be moved along the inner surfaces of the bottom wall 30 and inclined wall 102 for discharge onto the transverse conveyor 104. A hydraulic drive motor 116 is mounted at an upper end of the picker unit and includes an output sprocket gear 118 driving a sprocket chain 120 which drives a shaft 122 that has the two sprocket gears 110 mounted thereon thus driving both chains 100 and the paddles from the hydraulic drive motor 116 receiving hydraulic fluid pressure through supply and return hoses 124 in a wall known manner with control valves being provided in the cab for operating the hydraulic motor 116. A hydraulic motor 126 suspended from the frame below the drive sprocket 86 drives the drive sprocket 86 and the sprocket chain 84 for rotating all of the spiral coils 20 with hydraulic hoses 128 supplying hydraulic pressure to the hydraulic motor in a conventional manner. The controls in the cab may be used to vary the speed of rotation of the spiral coils and also vary the speed of the paddles and chains 100 to which the paddles are attached thereby controlling operation of the chili pepper harvester in order to optimize the picking efficiency. FIG. 7 illustrates the construction of the transverse conveyor 104 which receives the material from the paddles 98 as the paddles pass above the curved upper edge 106 of the inclined bottom wall 102 as illustrated in FIG. 3. The transverse conveyor 104 includes a belt conveyor 130 entrained over a pair of end rollers 132 and 134 with the upper run of the belt conveyor being supported by a slider bed 136. The roller 134 is driven by a hydraulic motor 138 communicated with hydraulic hoses 140 connected with a supply of hydraulic pressure and a control structure in the cab 16 of the harvester. The transverse conveyor 104 extends transversely across all four of the paddle conveyors for receiving all material moved upwardly along the inclined bottom wall 102 of each of the paddle conveyors. The material received on the conveyor 104 is moved transversely and discharged onto an upwardly and rearwardly extending conveyor 142 which includes a conveyor belt 144 with cleats or paddles 146 thereon. This conveyor is similar to the conveyor 30 in U.S. Pat. No. 5,210,999 and serves the same purpose by taking the material rearwardly for positioning in a rotatable separating drum, the details of which are the same as in the above mentioned patent number. The relationship of the discharge of the transverse conveyor 104 and the conveyor 144 is illustrated in FIG. 7 with the material passing from the conveyor 104 onto the conveyor 142 passing over and through an air gap 148 which has air flowing upwardly therethrough from an air duct 150 through a deflector structure 152 which discharges air upwardly and toward the conveyor 142 and through the air gap 148 as indicated by the arrows in FIG. 7. The air duct 150 is connected to a fan 154 positioned below the cab 12 and hydraulically powered and controlled from the cab. This structure provides an air blast separator for removing lightweight leaves and other debris and discharging it laterally of the upwardly and rearwardly extending conveyor 142. The conveyor 142 includes an outer wall 156 forming a portion of a receiving chute for the material discharged from the transverse conveyor 104. Mounted on the upper edge of the outer wall is a plurality of spaced fingers 158 mounted on a supporting rod 160 journaled from bearing supports 162. The rod 160 includes a laterally extending member 164 on an outer end thereof associated with an arcuate plate 166 rigid with the wall 156. The plate 166 is provided with a plurality of arcuately spaced apertures 168 therein for removably receiving a fastening bolt 170 extending through the member 164 and the arcuate plate 166 to secure the upwardly extending fingers in angular relation. This enables air and debris to pass through the space between the fingers and also upwardly over the fingers which are slightly outwardly curved while retaining any chili pepper pods that may not have fallen into the inlet chute of the upwardly extending conveyor 142 thus forming an adjustable separation for lightweight leaves and other debris from the chili pods prior to the chili pods moving up the conveyor 142 into the drum separator. Extending forwardly from the picker units 18 is a pair of leaf lifters generally designated by reference numeral 172 which are generally in the form of right triangular members having an upwardly facing edge 174 extending downwardly and forwardly from the front wall 114 of each picker unit. The leaf lifter includes an inner wall 176 and an outer wall 178 which are interconnected by the top wall to provide a hollow unit which may be closed on the bottom and provided with a ground engaging shoe 180 at the forward lower end thereof. The rearward bottom edge of the inner wall 176 includes a deflector plate 182 oriented generally horizontally for assisting the leaf lifter in guiding all of the plants and leaves of the chili pepper plants into the picker unit. The rearward edge of the inner wall 176 generally is aligned with but slightly outwardly of the inclined peripheral edge 184 of the front wall 114 to define an entrance area 186 between each pair of leaf lifters 172 for guiding the pepper plants into the picker units. The leaf lifters 172 are adjustably supported by a chain 188 connected to the interior surface of the inner wall with the chain links extending through a support plate 190 mounted on the front wall 114 and provided with a keyhole slot 192 to adjustably support the leaf lifter in vertically adjusted position as illustrated in FIG. 3. Also, the leaf lifter 172 and the front wall 114 of the picker unit are interconnected by a plurality of support arms 194 which extend upwardly and rearwardly from their point of attachment with the leaf lifter to their point of attachment with a bracket 196 mounted on the front wall 114 of the picker unit thus floatingly supporting the weight of the leaf lifters so that they will more effectively follow the contour of the ground surface and even if the bottom of the leaf lifter comes into contact with the ground surface, the leaf lifter will move upwardly without the nose end 180 digging into the ground surface. The down position or lowest position of the leaf lifters is controlled by the length of the chain 188 and tension springs can be provided between the leaf lifters and wall 114 to enable floatation of the leaf lifters. The spiral coil picker units are adjustable toward and away from each other as set forth previously which provides for cleaner picking of the product from the plant. Plant varieties and growing seasons as well as farming practices control growth and stage of green leaves or dry leaves after frost with the adjustment of the spiral coil picking units enabling maximum crop to be harvested from the plants in the field. The adjustment of the spiral coil picker units can be easily performed by the operator in the field with very little appreciable down time of the machine. The pepper pods picked from the plants are deposited laterally outwardly in relation to the spiral coil picker units and the paddles move the picked pepper pods from the picker units to the transverse conveyor 104. The paddles 98 are attached to the chain 100 at the outer ends of the paddles with the inner edges of the paddles being inclined slightly with the paddles moving upwardly along with the chain along the surface of the inclined bottom 102 with the chain and paddles passing over the sprocket gear 110 and the material being conveyed along the surface of the inclined bottom member 102 being deposited onto the transverse conveyor 104. Inasmuch as the paddles 98 are attached to and supported from the chain at only one end thereof, the paddles 98 are supported by a guide brace 198 as they pass the upper ends of the spiral coil picker units 20 to keep the paddles from hitting the top of the picker units. The spiral coils may vary in size but have preferably a diameter of about 8 inches with a height of approximately 24 inches and approximately 6 convolutions. The pepper plants are guided into the entranceway 186 by the leaf lifters 172 and the inclined walls 184 and pass through the space 38 as the spiral coils engage and remove the chili pepper pods. Four spiral picking coils 20 are positioned along each side of the area 38 through which the pepper plants pass. The fourth or innermost spiral picking coil is provided with a shield 200 which partially encloses the spiral picking coil which prevents the spiral picking coil from throwing chili pods out the back into the row and deflects the chili pods picked down into the paddles to be moved to the transverse conveyor. Air flow through the duct 150 to the air gap 148 may be controlled by a manually pivotal and adjustable baffle which controls the velocity of air to blow trash from the chili product as it falls from the transverse conveyor into the upwardly inclined conveyor with the fingers 158 retaining chili pods while permitting leaves and trash to escape. The chili pods fall down onto the upwardly and rearwardly extending conveyor for discharge into the rotating separator drum for travel through the remainder of the chili pepper harvester as disclosed in U.S. Pat. No. 5,210,999. The foregoing is considered as illustrative only of the principles of the invention. Further, since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation shown and described, and, accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the invention.

1a

FIELD OF INVENTION This invention generally relates to a vapor-dispensing device, and more particularly to a multiple-outlet vapor dispensing device. BACKGROUND OF INVENTION Vapor-dispensing devices of the type inserted into common electrical outlets are generally known. Many such devices require a particular positioning or orientation relative to the outlet due to the polar configuration and dimensioning of the electrical prongs and corresponding outlet openings. For example, in the United States, many standard polar two-prong devices include a larger prong and a smaller prong corresponding respectively to the two electrical poles and differentiated openings of the wall outlet. Some devices require that the poles and thus the prongs be aligned for proper operation of the device. Other devices may employ the polar plug design merely to provide improved stability, particularly if the device does not have a third prong for grounding. Problems may arise, however, when electricians install a polar or other standard outlet upside down, which is sometimes an industry practice used to indicate when the outlet is coupled to a light switch. In such cases, orienting a device having polar prongs with the inverted polar outlet may cause inferior performance, instability or failure of the device. In the case of air fresheners or other devices employing a liquid medium, it is a concern that inversion of the device may result in condensation or leakage of the liquid medium. Furthermore, various dispenser components such as wicks, emanators, or dispersion passages may rely on gravity or may be otherwise dependent on a particular orientation. Similarly, problems may be encountered when a device is plugged into an outlet that is installed horizontally. Accordingly, there is a need for means to properly orient such devices relative to an inverted outlet and/or for means to render such devices capable of operation in multiple orientations. SUMMARY OF INVENTION While the way that the present invention addresses the disadvantages of the prior art will be discussed in greater detail below, in general, the present invention provides means associated with a dispensing device for compensating for various orientations of an outlet into which the device is to be inserted. In accordance with various aspects of the present invention, operational independence of a dispenser and/or reservoir relative to an outlet orientation may be accomplished with a base member configured to be oriented independent of the outlet orientation, a reservoir configured to be oriented independent of a base member orientation, a reservoir and associated dispenser configured to operate in multiple orientations, or a pair of sleeved wicks configured for selective transport of dispersible material based upon device orientation. BRIEF DESCRIPTION OF THE DRAWINGS A more complete understanding of the present invention may be derived by referring to the detailed description and claims when considered in connection with the Figures, wherein like reference numerals refer to similar elements throughout the Figures, and FIG. 1 illustrates an exemplary dispensing device according to one embodiment having an orientation sensor; FIGS. 2A–2C illustrate exemplary dispensing devices according to various embodiments having various emanator configurations; FIG. 3 illustrates an exemplary dispensing device according to an embodiment having a reversible outlet body; FIG. 4 illustrates an exemplary dispensing device according to an embodiment employing an inverted polar prong adapter; FIG. 5 illustrates an exemplary dispensing device according to an embodiment having rotatable polar prongs; FIG. 6 illustrates an exemplary dispensing device according to an embodiment having a pair of inversely operable sleeved wicks; and FIG. 7 illustrates an exemplary dispensing device according to an embodiment having a pair of inversely operable sleeved wicks in separate reservoir compartments. DETAILED DESCRIPTION The following description is of exemplary embodiments of the invention only, and is not intended to limit the scope, applicability or configuration of the invention in any way. Rather, the following description is intended to provide a convenient illustration for implementing various embodiments of the invention. As will become apparent, various changes may be made in the function and arrangement of the elements described in these embodiments without departing from the scope of the invention as set forth herein. It should be appreciated that the description herein may be adapted to be employed with alternatively configured devices having different shapes, components, delivery mechanisms and the like and still fall within the scope of the present invention. Thus, the detailed description herein is presented for purposes of illustration only and not of limitation. Various outlet orientation compensating means are disclosed herein in the exemplary context of air fresheners. That being said, the present invention may be used with any vapor-dispensing products. Such products typically include a volatizable material and a transport system configured to facilitate evaporation of the volatizable material into the surrounding air. Exemplary volatizable materials include fragrances, air fresheners, deodorizers, odor eliminators, odor counteractants, insecticides, insect repellants, medicinal substances, disinfectants, sanitizers, mood enhancers, and aroma therapy compositions. Thus, “air freshener” as used herein refers to any vapor dispensing device similarly described in connection with polarized dual-outlet receptacles. That being said, such air fresheners may be used in connection with any configuration or orientation of receptacle. Air fresheners may be passive in operation, i.e., they may operate by ambient evaporation without the need for additional energy input to the system, or they may be active, requiring additional energy input, for example, in the form of heating elements or fans. Conventional air fresheners often include a refillable or replaceable reservoir. An exemplary air freshener according to the present invention comprises a low profile dispensing device that resembles a standard dual electrical outlet and includes a base member having at least one pair of electrical prongs for insertion into an electrical wall outlet, a secondary electrical outlet, and a heating element for heating a volatile material. A replaceable or refillable reservoir containing volatile material is attachable to the base member and associated with a dispenser, e.g., an emanator pad. The device further includes orientation compensating means allowing for upright orientation of the reservoir, base member, dispenser and/or other components independent of the orientation of the wall outlet (e.g., upright, horizontal, or inverted). “Upright,” as used herein refers to a target or default orientation. Orientational and/or operational independence of the reservoir or dispenser relative to the outlet orientation may be accomplished by numerous configurations. For example, briefly, one embodiment includes a base member configured to be oriented independent of an outlet orientation. Another embodiment includes a reservoir configured to be oriented independent of a base member orientation. Another embodiment includes a reservoir and associated dispenser configured to operate in multiple orientations. Yet another embodiment includes a pair of sleeved wicks configured for alternate operation depending upon orientation. In sum, any number of air freshener components may be configured to accommodate multiple wall outlet orientations or multiple air freshener orientations. For example, with reference to FIG. 1 , an exemplary embodiment of an air freshener device 2 includes a base 4 , and a reservoir 6 . Base 4 includes electrical prongs (not shown) for insertion into a wall outlet, a pair of secondary outlets 8 , heating elements 10 and 12 , and a gravity switch 14 . Heating elements 10 and 12 are electrically connected through gravity switch 14 to the electrical prongs on base 4 . Gravity switch 14 is configured to selectively supply power to heating elements 10 and 12 based upon the orientation of base 4 . Gravity switch 14 may be activated by a weight or fluid acting under the influence of gravity. For example, heating element 10 may be powered with base 4 in an upright orientation while heating element 12 may be powered with base 4 in an inverted orientation. In an alternative embodiment, heating elements 10 and 12 may be simultaneously powered regardless of the orientation of base 4 . Heating elements 10 and 12 may be further configured to operate periodically or continuously. In another embodiment, selective activation of heating elements 10 and 12 may be manual or automatic through use of any other suitable control or sensor. Any number of heating elements may be used, configured, and located to suitably volatize dispersible materials with the device in multiple orientations. With reference now to FIGS. 2A–2C , another embodiment of device 2 is shown including an emanator 16 configured for multiple or universal orientation(s). Exemplary emanators 16 include an absorbent pad, evaporation surface, porous material or the like. As shown in FIG. 2A , emanator 16 may be disposed along a side portion of reservoir 6 or base 4 and configured to dispense a substantially consistent quantity of volatile material regardless of the orientation of reservoir 6 and/or base 4 . For example, emanator 16 may be symmetrically aligned with respect to an axis common to device 2 in multiple orientations. Further to this example, emanator 16 may be supplied by wicks (not shown) extending to either vertical end of reservoir 6 , accommodating multiple orientations of reservoir 6 . Alternatively, emanator 16 may be configured in any manner suitable to allow for controlled dispensing of volatile materials with the reservoir in at least an upright and an inverted orientation. For example, as shown in FIG. 2B , emanator 16 may be disposed in multiple locations around the periphery of base 4 or reservoir 6 or may be configured as a substantially continuous ring. In yet another embodiment shown in FIG. 2C , emanators 16 are placed at each longitudinal end of device 2 for cooperation with heating elements 10 and 12 on base 4 , as shown in FIG. 1 . As described above, emanators 16 may be selectively supplied with heat and/or volatile material according to the orientation of device 2 . In various other embodiments of device 2 , any number of device components may be configured to accommodate various wall outlet or device component orientations. One such exemplary embodiment, includes spacing reservoir 6 a sufficient distance from base 4 to allow sufficient air flow past emanator 16 and/or providing an enlarged emanator 16 to accommodate any excess or variations in the transport or dispersion of volatile materials resulting from the various device orientations. Alternatively, use of a smaller quantity of volatile material, as with a smaller reservoir 6 or smaller emanator 16 , may serve to reduce leakage in the event that device 2 is inverted. Similarly, in embodiments employing a wick to transport volatile material from reservoir 6 to emanator 14 , the wick may be configured to meter capillary transport regardless of device orientation, for example by altering the composition or porosity of the wick. In another embodiment, the composition of the volatile material may be selected to achieve substantially uniform delivery regardless of orientation, for example, by use of a gel instead of an oil carrier. In another embodiment shown in FIG. 3 , base 4 is comprised of a base plate 18 and a removable, reversible outlet body 20 having a first polar outlet 22 and a second polar outlet 24 coupled to at least one of a first and second pair of polar prongs 26 . Outlet body 20 has a symmetrical profile, e.g., rectangular, and includes electrical outlets 22 and 24 . A first symmetrical opening 28 in base plate 18 and a second symmetrical opening 30 in reservoir 6 accommodate the corresponding symmetrical profile of outlet body 18 in both the upright and inverted orientation. Use of a symmetrical outlet body 20 and corresponding opening 28 allows base plate 18 to be attached to outlet body 20 in an upright orientation regardless of whether outlet body 20 is upright or inverted. That being said, any suitable combination of outlet body profiles and complimentary openings 28 and 30 may be used such that outlet prong pairs 26 on outlet body 20 are first inserted into a wall outlet according to the orientation of the wall outlet and then base plate 18 and/or reservoir 6 are then attached to outlet body 20 in the upright position. With continued reference to FIG. 3 , outlet body 20 further includes electrical contacts 32 for communicating power to heating element(s) 10 by means of electrical leads 34 on base plate 18 . Electrical contacts 32 are located along a centerline of outlet body 20 to contact heating element leads 34 located along a centerline of base plate 18 with outlet body 20 in either the upright or the inverted position. Thus, reservoir 6 and base plate 18 may both be removable and rotatable relative to outlet body 20 . Electrical leads 34 and electrical contacts 32 may be further configured as the means of attachment between base plate 18 and outlet body 20 . This may be accomplished, for example, by configuring electrical contacts 32 to securely receive or otherwise attachably engage heating element leads 34 . For example, in one embodiment, electrical leads 34 include protruding posts and electrical contacts 32 include grooves for receiving the protruding posts. Electrical contacts 32 of outlet body 20 and electrical leads 34 of base plate 18 may be configured in any suitable manner to allow for proper orientation of heating element 10 and/or other dispensing mechanism relative to an upright, inverted, or rotated outlet body 20 . Alternatively, base plate 18 or reservoir 6 may be press-fitted, snap-fitted, slidably fitted or otherwise suitably attached to outlet body 20 to cause electrical leads 34 to engage electrical contacts 32 . Reservoir 6 and base plate 18 may be separately attachable to outlet body 20 . Alternatively, reservoir 6 may attach to base plate 18 and the combination may then attach to outlet body 20 . It is understood that reservoir 6 , base plate 18 , and outlet body 20 may be assembled and attached in any suitable manner. That being said, any of the embodiments described herein may be used with purely passive delivery systems as well, i.e., without the need for heating element 10 , electrical contacts 32 , electrical leads 34 , fans, or the like. For example, a simple wick and emanator 16 associated with reservoir 6 may be maintained upright by any number of means described herein. In accordance with one embodiment, device 2 is specifically configured to accommodate an inverted outlet by means of inverted polar prongs. This may be done by reversing the positions of the larger and smaller prongs. Thus, a reservoir, emanator, and wick may be maintained upright without further structural modifications. In another embodiment shown in FIG. 4 , outlet body 20 including polar electrical prongs 26 may be maintained in an upright orientation by use of an inverter adapter 36 interposed between the upright outlet body 20 and an inverted wall outlet. Polar electrical prongs 26 on inverted adapter are geometrically inverse to those of outlet body 20 allowing for upright orientation of outlet body 20 . With reference now to FIG. 5 , still another embodiment includes an outlet body 20 having a pair polar prongs 26 integrated into a rotator(s) 38 moveable between multiple positions to allow for multiple orientations of the device relative to a wall outlet. For example, a single pair of polar prongs 26 may be rotated as desired between 0 and 360 degrees, while two pairs of polar prongs may be jointly rotated 180 degrees by turning rotator(s) 38 . In another embodiment, two pairs of polar prongs 26 are fixed to a single rotator 38 . Any means of reorienting polar prongs 26 with respect to outlet body 20 , whether now known or later developed, may be used in conjunction with the present invention. Another exemplary embodiment includes a baffle(s) adjacent emanator 16 to absorb and/or divert any leaked, condensed, or excess volatile dispersible materials released in a given orientation of the device. Baffles may be associated with emanator 16 or any other dispensing mechanism or other device component. One exemplary baffle is composed of an absorptive material placed in close proximity to emanator 16 . Baffle may be any material or structure configured to absorb, stop, divert, or otherwise contain leaked or condensed volatile materials. In one embodiment, baffles are provided on two sides of emanator 16 , one to contain leakage, the other to contain condensation. With reference now to FIG. 6 , accommodation of multiple outlet orientations is accomplished by a first wick 102 encased in a first sleeve 104 and a second wick 106 encased in a second sleeve 108 . Wicks 102 and 106 communicate dispersible materials from reservoir 6 to emanators 16 located at opposite ends, i.e., top and bottom, of reservoir 6 . Sleeves 104 and 108 are composed of an impermeable material and configured to selectively enable or block capillary transport through wicks 102 and 106 . Wicks 102 and 106 extend to opposite ends of reservoir 6 such that wick 102 is in contact with dispersible materials while wick 106 is shielded by sleeve 108 in the upright orientation, and the inverse relationship exists in a second orientation. In one embodiment, sleeves 104 and/or 108 may extend the full length of wick 102 and 106 or beyond such that wicks 102 and 106 contact dispersible materials within the sleeve. Alternatively, sleeves 104 and 108 may include any means to allow absorption of dispersible materials, for example, perforations or other openings towards one end or a bell formation around and/or past the end of wicks 102 and 106 to allow increased contact with dispersible materials in a given orientation. In yet another embodiment shown in FIG. 7 , two separate reservoir compartments 110 and 112 within reservoir 6 contain two distinct dispersible materials. Wick 102 is in communication with one of the two dispersible materials in a first reservoir orientation. Conversely, wick 106 is in communication with the other dispersible material in a second reservoir orientation. In other words, in an upright orientation, a portion of a wick 102 is in contact with the dispersible materials of first reservoir compartment 110 while a portion of wick 106 is maintained above the dispersible materials of second reservoir compartment 112 . Inverting reservoir 6 causes a portion of wick 106 to contact the dispersible materials of second reservoir compartment 112 and further causes wick 102 to be withdrawn or isolated from the dispersible materials of first reservoir compartment 110 . Wicks 102 and 106 may supply a common emanator 16 or separate emanators 16 . By using two distinct dispersible materials and separate emanators 16 , alternate dispersions such as varying scents may be obtained simply by reorienting reservoir 6 . As discussed above, wicks 102 and 106 need not extend beyond sleeves 104 and 108 to contact the dispersible materials. For example, in one embodiment, sleeves 104 and 108 may be dimensioned to provide an open annular chamber around a length of wicks 102 and 106 . Accordingly, dispersible liquids may flow into the annular chamber up to the level of the liquid in reservoir 6 . In one embodiment, wicks 102 and 106 and sleeves 104 and 108 may be configured at an angle within reservoir 6 such that liquids may flow from the annular chamber as reservoir 6 is rotated between positions. Any suitable means of allowing contact or blocking contact with dispersible materials by wicks 102 and 106 may be used in accordance with the present invention. By configuring sleeves 104 and 108 to extend the length of wicks 102 and 106 , a greater volume of reservoir 6 and/or reservoir compartments 110 and 112 may be filled with dispersible materials. In other words, because the full length of wicks 102 and 106 are shielded, the fluid level may likewise rise to the full length of a shielded wick before fluid transport begins. Finally, while the present invention has been described above with reference to various exemplary embodiments, many changes, combinations and modifications may be made to the exemplary embodiments without departing from the scope of the present invention. For example, the various components may be implemented in alternate ways. These alternatives can be suitably selected depending upon the particular application or in consideration of any number of factors associated with the operation of the system. In addition, the techniques described herein may be extended or modified for use with other types of devices. These and other changes or modifications are intended to be included within the scope of the present invention.

1a

PRIORITY This application claims priority to U.S. Provisional Application No. 61/488,014 filed May 19, 2011, and is a continuation in part application of U.S. application Ser. No. 12/025,028, which filed Feb. 2, 2008 and issued as U.S. Pat. No. 8,286,284 on Oct. 16, 2012, which claims priority to U.S. Provisional Application No. 60/980,768 filed Oct. 17, 2007, to U.S. Provisional Application No. 60/887,932 filed Feb. 2, 2007, and to International Application No. PCT/US08/52868 filed Feb. 3, 2008, each of which are incorporated herein by reference. BACKGROUND 1. Field of the Invention The present invention relates generally to an emergency rescue device and method for operation thereof to enable rapid removal of an injured individual from hazardous locations and, more specifically, emergency rescue device that combines a base panel formed of a flexible sheet material and a harness coupled to the base panel to securely restrain the injured individual. 2. Description of the Related Art Stretchers of various types have been developed to move injured individuals. Stretchers of different types and configurations have also been developed to safely and efficiently move an injured individual from an emergency situation, for example an individual found injured in a burning building or a soldier injured on a battlefield. A conventional emergency stretcher is provided by Skedco, Inc. that combines features of a sled and a skid, and is often referred to as a ‘SKED’. Components of the SKED are disclosed in U.S. Pat. No. 6,871,368 to Calkin. The SKED is manufactured from a single piece of material, can be stored flat, and is manipulated by a user into a functioning configuration. An injured individual is loaded onto the SKED device, which is then skidded across varied types of terrain. However, the individual is secured within the SKED device using a plurality of pairs of conventional seat-belt style straps, and the plastic used to manufacture the SKED device has a shape memory. This arrangement creates an inefficient and time consuming process to secure the injured individual. Moreover, the SKED device does not provide a self-contained packing arrangement to protect the straps and also position the straps for immediate deployment. Rather, a separate cover is needed to protect the straps of the SKED device. Use of such separate cover further delays deployment of the SKED device. Accordingly, the SKED device does not ensure an efficient process for securing an injured individual. The delays in deploying the SKED device are undesirable, particularly if the SKED device is used in emergency situations. Another conventional drag-style emergency evacuation stretcher is disclosed by U.S. Pat. No. 7,699,324 to Walkingshaw et al. (“Walkingshaw”). Like the SKED, the Walkingshaw device is manufactured from a single piece of material. The Walkingshaw device can be stored flat and is folded into a functioning configuration. Also like the SKED, the Walkingshaw device utilizes a conventional seat-belt style straps to secure an injured individual therein and fails to provide a self-contained packing arrangement that protects the straps from the elements while also maintaining the harness straps in a stored state that allows for immediate deployment. Yet another conventional stretcher is U.S. Pat. No. 7,168,110 to Girard et al. (“Girard”), which discloses a transfer stretcher and harness for lifting, transferring or supporting a person—in particular an overweight person—via a single lift point, typically by use of lifting equipment. However, the transfer stretcher of Girard is not arranged for use as an emergency evacuation stretcher, particularly when immediate deployment is needed, such as for fire rescue or battlefield scenarios. Another example of a conventional emergency stretcher is provided by U.S. Pat. No. 6,871,368 to Catkin, which a flexible drag stretcher that can be stored and transported in a tightly rolled, compact cylindrical storage condition for hand carrying and for mounting on a backpack, to be unrolled into an operative stretcher condition having a single center base panel formed of a flexible sheet material onto which a pair of opposite, flexible side torso flap members are mounted to cinch against the sides of only the torso portion of an injured person's body to secure the injured person to the stretcher during stretcher operation. However, like the other conventional stretchers, the emergency personal must follow numerous and time-consuming steps to secure the injured person in the device. SUMMARY OF THE INVENTION The present invention provides an apparatus and method providing a lightweight, readily compactable, rescue device for evacuation and emergency use including transporting, dragging and lifting of an injured individual. An aspect of the present invention fully secures an injured individual without use of complex strapping configurations of conventional devices, thereby providing a more efficient device better suited for emergency evacuation. In addition, an aspect of the present invention provides a rescue stretcher that utilizes the body support member as a primary means for securely restraining the injured individual, with a harness strapping systems that fully secures the individual to allow for dragging operation, as well as multiple lift point operation. Another aspect of the present invention provides a rescue device with fastening harness members that fasten to a single location for rapid deployment with a self-contained storage bag that protects the harness members from deterioration while allowing for immediate and rapid deployment of the harness members. Yet another aspect of the present invention provides an emergency rescue device that combines a base panel formed of a flexible sheet material and a harness, with the harness having straps that fasten to a single location to securely restrain an injured individual while simultaneously holding the base panel against the individual, thereby allowing the individual to be dragged or vertically lifted using the stretcher device, while the base panel protecting the individual. Another aspect of the present invention provides a rescue device that includes a harness bag for storing harness straps therein, to protect the straps during periods of non-deployment and facilitates expedited strap deployment. The harness bag includes a plurality of reinforced slots/slits through which the straps, including haul straps, shoulder straps, waist straps and groin straps, extend from within the harness bag interior. In a non-deployed state, excess strap slack is releasably held within the harness bag with connecting ends of each strap, including mating fasteners, being releasably secured on an exterior surface of the harness bag, with the straps passing through respective slots/slits. When in a deployed state, end portions of the straps are extracted from the harness bag to wrap the straps around the individual who is being restrained in the harness device. A further aspect of the present invention provides a rescue device with a base panel removably coupled to a harness for securing an individual to be rescued when the rescue device is in the deployed state, with the harness being enclosed within and protected by the base panel when the rescue device is in the non-deployed state, when the base panel and the harness are rolled into a storage state. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 illustrates a base panel of a rescue device according to an exemplary embodiment of the invention; FIG. 2 illustrates a harness according to an exemplary embodiment of the invention, for use with the base panel shown in FIG. 1 ; FIG. 3 illustrates the rescue device formed by the base panel and harness of FIGS. 1 and 2 , respectively; FIG. 4 shows the rescue device of FIG. 3 operatively supporting an injured individual; FIG. 5 illustrates a drag stretcher device according to another exemplary embodiment of the invention; FIG. 6 illustrates a drag stretcher device according to another exemplary embodiment of the invention; FIGS. 7-9 illustrate a drag stretcher device according to another exemplary embodiment of the invention, including a harness bag; and FIGS. 10A-10C illustrate a drag stretcher device according to another exemplary embodiment of the invention; FIG. 11 shows an individual secured in the drag stretcher device of FIGS. 10A-10C ; and FIG. 12 shows the drag stretcher device in a storage state. DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS FIGS. 1-3 illustrate a rapid intervention rescue device according to an exemplary embodiment of the invention. In particular, FIG. 3 illustrates a rescue device ( 30 ) according to an exemplary embodiment of the invention, which includes a base panel ( 10 ) formed of a flexible sheet material, separately shown in FIG. 1 , and a harness ( 20 ), which is separately shown in FIG. 2 . The base panel ( 10 ) is formed of a flexible sheet material having a top end (T) and bottom end (B). The base panel ( 10 ) is preferably formed pliable plastic materials or polyurethane, preferably being flexible and not having a shape retaining memory, to provide hardness and durability to protect the individual being rescued. Preferably, base panel ( 10 ) does not retain any shape memory, to facilitate and expedite loading of an injured person by a single rescuer. The base panel ( 10 ) includes a plurality of harness strap holes ( 10 a ) formed at various positions along a first side edge and a plurality of harness strap holes ( 10 b ) formed at various positions along a second side edge of the base panel ( 10 ). As explained below, the harness strap holes ( 10 a , 10 b ) insertably receive portions of the harness straps in manner that allows the harness, such as shown in FIG. 2 , to be coupled to the base panel ( 10 ) by lacing strap of the harness device through the holes ( 10 a , 10 b ). The harness strap holes ( 10 a 10 b ) can be cut or otherwise stamped in the sheet material forming the base panel ( 10 ) and such strap holes can be reinforced using metal, such as brass or stainless steel, or reinforced with plastic grommets. Moreover, the base panel ( 10 ) includes strips of Velcro™ ( 11 - 15 ) strategically placed in position to interface with mating Velcro™ strips affixed to regions along the various straps of the harness ( 20 ) and further serves to hold the harness ( 20 ) in position on the base panel ( 10 ). FIG. 2 illustrates an exemplary harness ( 20 ) according to an exemplary embodiment of the invention, which may be used with the exemplary base panel ( 10 ) of FIG. 1 . The harness ( 20 ) includes elongated cross-body straps ( 21 - 23 ) or waist straps, elongated holding straps ( 24 , 25 ), a pull handle strap ( 26 ) or tow handle, and a groin strap ( 27 ). The elongated body straps ( 21 - 23 ) each have looped ends ( 21 a , 21 b ), ( 22 a , 22 b ) and ( 23 a , 23 b ), respectively. A portion of respective body straps ( 21 - 23 ) may have Velcro™ strips ( 21 c , 22 c , 23 c ) attached thereto, which are designed to mate with corresponding Velcro™ strips ( 11 - 13 ) affixed on the base panel ( 10 ). The elongated body straps ( 21 - 23 ) are preferably interconnected by box stitching with a cross-strap ( 28 ). The elongated holding strap ( 24 ) includes a locking clip fastener ( 24 a ) such as a snap clip connected on one end thereof and a looped end ( 24 b ). The elongated holding strap ( 25 ) includes a metallic ring fastener ( 25 a ), such as a bull ring, connected on one end thereof and a looped end ( 25 b ). The handle strap ( 26 ) includes an elongated length of strap material having first and second looped ends ( 26 a , 26 b ). A connector ( 29 ), such as a carabineer, may be used to enable the handle strap ( 26 ) to be connected to a safety line device or other equipment, otherwise the handle ( 26 ) can be physically pulled by hand. The groin strap ( 27 ) includes clip fastener ( 27 a ) and strap portions ( 27 b , 27 c , 27 d ) where the clip fastener ( 27 a ) is attached to one end of strap portion ( 27 b ) and where strap portions ( 27 c , 27 d ) may have strips of Velcro™ attached thereto which are designed to mate with corresponding Velcro™ strips ( 14 - 15 ) on the base panel ( 10 ). The ends of the strap portions ( 27 c , 27 d ) are box stitched to the elongate body strap ( 23 ). It should be understood that the cross-straps ( 28 ) and groin strap portions ( 27 c , 27 d ) may be formed by two elongated lengths of strapping which are arranged and box stitched to the elongated body straps ( 21 - 23 ) in a way to form the cross strap layout with extended pieces forming the strap portions ( 27 c , 27 d ). The groin strap ( 27 ) may have a ring connector connected to the groin strap portion ( 27 b ), where the strap portions ( 27 b , 27 c and 27 b ) meet, allowing connection to another carabineer ( 29 ) clip of another rescue device to form a connecting chain of rescue devices that can be pulled together to extricate multiple injured or dead individuals from a given location. The harness ( 20 ) may be formed of any suitable strapping or webbing material that is rated for a desired strength and durability for the intended purposes. For example, in firefighting applications, the harness straps forming the harness ( 20 ) may be formed of flexible tubular webbing preferably formed of non-abrading, flame-resistant material that uses aramid fibers such as Kevlar™ and Nomex™. In other applications, the harness straps may be formed of nylon, polyester or other suitable materials. FIG. 3 illustrates a drag rescue stretcher device ( 30 ) which includes an assembly of the exemplary base panel ( 10 ) and harness ( 20 ), wherein the harness ( 20 ) is removably connected to the base panel ( 10 ) by lacing portions of the harness straps through the strap holes in the base panel ( 10 ) and coupling the mating Velcro™ strips on the harness straps to the Velcro™ strips on the base panel ( 10 ). In particular, in the exemplary embodiment of FIG. 3 , the harness ( 20 ) can be coupled to the base panel ( 10 ) by inserting the looped ends ( 21 a , 22 a , 23 a ) of the elongated straps ( 21 - 23 ) through corresponding strap holes ( 10 a ) on the left peripheral side edge of base panel ( 10 ) and by inserting the looped ends ( 21 b , 22 b , 23 b ) through corresponding strap holes ( 10 b ) on the right peripheral side edge of the base panel ( 10 ). The harness ( 20 ) is held in place on the base panel ( 10 ) via the corresponding mating Velcro™ strips ( 21 c / 11 ), ( 22 c / 12 ), 23 c / 13 ), ( 27 c / 15 ) and ( 27 d / 14 ) that are stitched to the portions of the elongate straps ( 21 - 23 ) and glued to the base panel ( 10 ). Moreover, the pull handle strap ( 26 ) is laced through corresponding strap holes on the base panel ( 10 ) by inserting the looped end ( 26 a ) of the pull handle strap ( 26 ) through the upper strap holes ( 10 a ) and by inserting the looped end ( 26 b ) of the pull handle strap ( 26 ) through the upper strap holes ( 10 b ). The pull handle strap ( 26 ) is coupled to the harness waist straps by, e.g. inserting the looped end ( 21 a ) of the elongated body strap ( 21 ) through the looped end ( 26 a ) of the handle ( 26 ), and by inserting the looped end ( 21 b ) of the elongated body strap ( 21 ) through the looped end ( 26 b ) of the pull handle strap ( 26 ), as shown in FIG. 3 . The holding strap ( 24 ) is laced through the looped ends ( 21 a , 22 a , 23 a ) of the elongated body straps ( 21 - 23 ) and the holding strap ( 25 ) is laced through the looped ends ( 21 b , 22 b , 23 b ) of the elongated body straps ( 21 - 23 ). The drag rescue stretcher ( 30 ) can be deployed as follows. An injured individual is placed onto the base panel ( 10 ) with a torso of the individual aligned with the base panel ( 10 ). When maneuvering the individual onto the base panel ( 10 ), the harness device ( 20 ) will be maintained in proper position on the base panel ( 10 ) by, e.g. Velcro™ strip connections between the harness device ( 20 ) and base panel ( 10 ). When the individual is in proper position, the loose end of the groin strap portion ( 27 b ) with the clip fastener ( 27 a ) is passed between an individual's legs in the groin region such that the clip ( 27 a ) is brought to a front torso region of the individual. Moreover, the clip fastener ( 24 a ) of the holding strap ( 24 ) is passed through the looped end ( 24 b ) to form a closed loop and the clip fastener ( 24 a ) is brought to the front torso region of the individual. Similarly, the ring fastener ( 25 a ) of the holding strap ( 25 ) is passed through the looped end ( 25 b ) to form a closed loop, and the ring fastener ( 25 a ) is brought to the front torso region of the individual, where the clip fastener ( 24 a , 27 a ) are connected to the ring fastener ( 25 a ). In this manner, the harness ( 20 ) essentially encloses and surrounds the torso of the individual. The lengths of the elongated body straps ( 21 - 23 ) and holding straps ( 24 , 25 ) are preferably designed such that the harness ( 20 ) is relatively tightly secured around the torso of the individual upon connection of the clips ( 24 a , 27 a ) to the ring ( 25 a ) with the side portions of the base panel ( 10 ) being drawn against the sides of the individual. FIG. 4 is a perspective view of the assembly of FIG. 3 operatively deployed to secure an injured individual. In operation, the drag rescue stretcher can be used to drag an individual where the base panel ( 10 ) is designed to readily slide over various surfaces while protecting the back and side torso regions of the individual. Moreover, the drag rescue stretcher ( 30 ) can be used for vertical lift applications where the carabineer ( 29 ) is hooked to a haul line to pull the individual out of a hole or up a flight of stairs, for example. The dimensions of the base panel ( 10 ) can vary depending of the application. For example, the overall width of the base panel ( 10 ) can be made sufficiently wide to wrap around the sides and backside of the torso, as shown in FIG. 4 . Moreover, the base panel ( 10 ) has a length sufficient to receive and support the individual's head and torso. In the embodiment shown in FIG. 4 , the individual's legs and hips can bend while secured to the stretcher device ( 30 ), to facilitate extrication from confined places and where tight turns must be navigated, e.g. firefighting applications where an injured firefight must be dragged through winding hallways of a burning home or building. In other embodiments, the base panel ( 10 ) is provided in a length that supports full-body protection, preferably by inclusion of a separate panel that is removably attached to the bottom end (B) of the base panel ( 10 ) and is extends away from the base panel ( 10 ) for leg support, to provide a full length drag stretcher device. The pull handle strap ( 26 ) is used to pull the drag rescue stretcher ( 30 ) while the individual is secured therein. In the exemplary embodiment of FIG. 3 , the pull strap handle ( 26 ) is not fixedly attached to the base panel ( 10 ) and does not pull directly on the base panel ( 10 ) during a drag or lift operation. Instead, the looped ends ( 26 a , 26 b ) of the harness handle ( 26 ) are slideably attached to the looped ends ( 21 a , 21 b ) of the upper elongated body strap ( 21 ) such that in effect, the handle ( 26 ) actually pulls on the harness ( 20 ) in which the individual is secured. In the exemplary embodiment of FIG. 3 , the pulling of the handle ( 26 ) operates to remove slack and more tightly secure and cinch the harness ( 20 ) around the torso region. The clip fasteners ( 24 a , 27 a ) on the holding strap ( 24 ) and groin strap ( 27 ) may allow for adjustment of the length of the strap members ( 24 , 27 ), so as to accommodate individuals of different size and bulk, and to permit an individual to be fully and positively secured, while using the pulling action of the handle on the elongated body strap ( 21 ) to effectively remove any slack in the harness ( 20 ) and more tightly cinch the harness ( 20 ) around the individual. FIG. 5 illustrates a drag rescue stretcher device ( 40 ) according to another exemplary embodiment of the invention, which includes an assembly of a base panel ( 50 ) and a harness ( 60 ). In general, the base panel ( 50 ) is formed of a flexible sheet material having a plurality of apertures ( 51 - 56 ) formed at top (T) and side regions (S 1 , S 2 ) of the base panel ( 50 ). The apertures ( 51 , 52 , 53 and 54 ) are preferably formed as thin slots to insertably receive harness straps of the harness ( 60 ). The apertures ( 55 , 56 ) are preferably formed to serve as handles that enable a rescuer to grab the drag stretcher base panel ( 50 ) by hand when necessary. The harness ( 60 ) includes elongated straps ( 61 - 64 ) that extend between top (T) and bottom (B) ends of the base panel ( 50 ), an elongated waist strap ( 65 ) that extends between sides S 1 and S 2 of the base panel ( 50 ), a groin strap ( 66 ) that is disposed at the bottom region of the base panel ( 50 ), and a support pad ( 67 ) that acts as a lumbar support. At the top end (T) of base panel ( 50 ), end portions of the elongated straps ( 61 - 62 ) are looped through respective aperture pairs ( 51 - 52 ) and are connected to form a pull handle strap. A connector ( 70 ) may be used to connect the end portions of straps ( 61 - 62 ) and to assist in dragging. Other means for connecting the ends of straps ( 61 - 62 ) may be used to form the strap loop, such as connecting the ends of the straps ( 61 - 62 ) via a water knot ( 70 ′), as shown in FIG. 6 . The connector ( 70 ) facilitates expedited connection of the handle strap to a safety line device or other equipment; and also allows the handle strap to be physically pulled by hand. Moreover, end portions of the elongated straps provide a pair of shoulder straps ( 63 - 64 ) that are connected at distal ends thereof via a clip fastener ( 74 ) to form shoulder harness straps, as shown in FIGS. 5-9 . The elongated straps ( 61 - 64 ) are connected to each other via box stitching and arranged in a crisscross pattern in region ( 69 ), as shown in FIG. 5 . The elongated straps ( 61 - 64 ) are further fixedly attached to a backside of the support pad ( 67 ), as shown in FIGS. 5-6 . The end portions of the elongated straps ( 61 - 64 ) converge at a bottom (B) of the base panel ( 50 ) and are connected to an end of the groin strap ( 66 ) via box stitch connection region ( 68 ), as shown in FIGS. 5-7 and 9 . Proximal ends of each strap of the pair of shoulder straps are fixedly connected to a proximal end of the groin strap at the box stitch connection region ( 68 ). The groin strap ( 66 ) includes clip fastener ( 73 ). The straps ( 61 - 62 ) are preferably formed from one continuous strap element that is folded and stitched at the box stitch connection region ( 68 ). Similarly, the elongated strap members ( 63 - 64 ) are preferably formed from one continuous length of strap that is folded and stitched at the box stitch connection region ( 68 ). The groin strap ( 66 ) may be an extended looped portion of the continuous strap element ( 63 , 64 ). The waist strap ( 65 ) is fixedly attached, for example by box stitching, to a backside of the support pad ( 67 ). A first end of the waist strap ( 65 ) is looped through the aperture ( 53 ) and handle ( 56 ) and includes a metallic locking clip fastener ( 71 ), such as a snap clip. A second end of the waist strap ( 65 ) is looped through the aperture ( 54 ) and handle ( 55 ) and includes a metallic ring fastener ( 72 ), such as a bull ring, connected thereto to provide a single fastener to couple each end portion of each harness strap when securing an individual within the rescue harness. The harness ( 60 ) is removably connected to the base panel ( 50 ) by inserting the ends of the elongated waist strap ( 65 ) through corresponding apertures ( 53 - 56 ) of base panel ( 50 ) and by inserting the ends of elongated straps ( 61 - 62 ) through corresponding apertures pairs ( 51 - 52 ) of base panel ( 50 ), as shown in FIG. 5 . The harness ( 60 ) may be formed of any suitable strapping or webbing material that is rated for a desired strength and durability for the intended purposes. The drag rescue stretcher ( 40 ) can be deployed as follows. An injured individual is placed onto the base panel ( 50 ) with individual's torso aligned with the base panel ( 50 ). When maneuvering the individual onto the base panel ( 50 ), the harness ( 60 ) is maintained in proper position on the base panel ( 50 ) by the Velcro™ strip connections between the harness straps and base panel. When the individual is in proper position, the loose end of the groin strap ( 66 ) with the clip fastener ( 73 ) is passed between the individual's legs in the groin region such that the clip ( 73 ) is brought to the individual's front torso region. Moreover, the clip fastener ( 71 ) of the waist strap ( 65 ) is brought to the front torso region. Similarly, the ring fastener ( 72 ) of the waist strap ( 65 ) is brought to the front torso region, where the clip fasteners ( 71 , 73 ) are connected to the ring fastener ( 72 ). Moreover, the shoulder strap loop formed by the connected ends of elongated straps ( 63 - 64 ) is looped over the individual's head and shoulders, whereby the clip fastener ( 74 ) is brought to the front torso region and connected to ring fastener ( 72 ). In this manner, the harness ( 60 ) encloses and surrounds the individual's torso. In other embodiments, a head support/strap system can be integrally connected to the base panel ( 50 ) in an upper region of the panel ( 50 ). In other embodiments, the harness straps ( 61 - 64 ) may be arranged in region ( 69 ) in a layout other than the crisscross pattern ( 69 ) shown in FIG. 5 . The crisscross pattern is advantageous to provide back support when an individual is strapped in the drag stretcher ( 40 ). The elongated straps ( 61 - 62 ) may be arranged to extend down either sides of the base panel ( 50 ) without crossing each other in region ( 69 ). For example, FIG. 6 schematically illustrates another exemplary embodiment of a drag rescue stretcher device ( 40 ′) that includes an assembly of a harness ( 60 ′) and base panel ( 50 ′), which is similar in design to the embodiment described in FIG. 5 . FIG. 6 further illustrates an exemplary head restraint device ( 80 ) that includes adjacent head pad restraint elements ( 81 - 82 ), between which the individual's head is positioned and secured by a strapping element ( 83 ). In other exemplary embodiments of the invention, harness is formed with a harness housing or harness bag that serves various functions such as providing protection for harness webbing and strap storage when the harness device is not deployed. For instance, FIGS. 7-9 schematically illustrate a rescue stretcher device ( 90 ) according to another exemplary embodiment of the invention, which is an extension of the rescue stretcher device of FIG. 5 that includes base panel ( 50 ), the harness ( 60 ) and includes harness bag ( 100 ). The harness bag ( 100 ) has a bottom layer and a top layer of material that are stitched together around perimeters thereof to form an interior cavity to contains the body of the harness ( 60 ). The harness bag ( 100 ) includes a plurality of reinforced slots/slits ( 61 a , 62 a , 63 a , 64 a , 65 a , 66 a ) to allow the end portions of the various harness straps, e.g. haul straps ( 61 - 62 ), shoulder straps ( 63 - 64 ), waist straps ( 65 ) and groin straps ( 66 ) of the harness system ( 60 ) to extend from within the interior cavity of the harness bag ( 100 ). The harness bag ( 100 ) also includes an elongated reclosable opening ( 101 ) formed in the central region of the top surface thereof. In one embodiment, the opening ( 101 ) is formed with overlapping mating portions ( 101 a , 101 b ) having mating connector mechanisms such as Velcro™ strips, as shown in FIG. 9 . The bottom exterior surface of the harness bag ( 100 ) may be removably or fixedly attached to the base panel ( 50 ), such as by use of corresponding mating Velcro™ strips that are stitched along portions of an exterior of a backside of the harness bag ( 100 ) and corresponding Velcro™ strips glued to portions on a surface of the base panel ( 50 ). The harness bag ( 100 ) also includes a plurality of strap fasteners ( 102 ) disposed on the exterior surface of the top layer of the bag ( 100 ) in proximity to each of the slots/slits ( 61 a , 62 a , 63 a , 64 a , 65 a , 66 a ), and a plurality of reflective patches ( 103 ) formed in proximity to each of the fasteners ( 102 ). As shown in FIG. 8 , when the rescue stretcher device ( 90 ) is not being used, i.e. is in a non-deployed state, the excess slack of the various straps, e.g. haul straps ( 61 , 62 ), shoulder straps ( 63 , 64 ), waist straps ( 65 ) and groin straps ( 66 ), of the harness device ( 60 ) are contained within the harness bag ( 100 ). Fasteners ( 102 ) are provided to releasably secure the distal end of each strap in a fixed position on an exterior surface of the upper layer of the harness bag ( 100 ) near the corresponding strap slits. The fasteners ( 102 ) may, for example, be straps having one end stitched to an exterior surface of the top layer of the bag ( 100 ) with Velcro™ connectors to strap down and hold the harness strap fasteners of the harness straps. In other exemplary embodiments, the harness strap fasteners disposed on the exterior of the bag ( 100 ) are stowed in pockets provided on the upper exterior surface of the bag ( 100 ) in proximity to the strap slits of the harness bag ( 100 ). FIG. 9 illustrates the device in FIG. 8 in the non-deployed state, showing the overlapping mating sides ( 101 a , 101 b ) separated along a length of the reclosable opening ( 101 ) to enable access the portion of the harness body contained within the interior cavity of the harness bag ( 100 ). When in the non-deployed state, excess slack of the elongated straps ( 63 - 66 ) that are stored inside the bag ( 100 ) are held in place using holding straps ( 104 , 105 ) or mating snap button connectors ( 110 a , 110 b ). As shown in FIG. 9 , the excess slack of the waist strap ( 65 ) is held in place inside the bag ( 100 ) using a strap fastener ( 104 ) provided by use of a Velcro™ strap. Similarly, a strap fastener ( 105 ) can be used to hold the excess slack of the groin strap ( 66 ) inside the harness bag ( 100 ). Moreover, the excess slack of the shoulder straps ( 63 , 64 ) can be held in place by connecting the mating snaps ( 110 a ) on the straps ( 63 , 64 ) to mating snaps ( 110 b ) connected to the lower straps ( 61 , 62 ) along the lengths between the support waist band ( 67 ) and the box stitch connection region ( 68 ). It is to be understood that for purposes of clarity, FIG. 9 does not show excess slack of the haul straps ( 61 , 62 ). When in the non-deployed state, strap element ( 64 ) is also stowed and releasably secured inside the harness bag ( 100 ), using snaps or strap mechanisms as discussed above. When deploying the rescue stretcher device ( 90 ) from the arrangement in FIG. 8 , a rescuer need not open the bag ( 100 ) via the opening ( 101 ) as shown in FIG. 9 to unfasten the straps ( 104 , 105 ) or to unsnap the snap connections ( 110 a , 110 b ). Rather, the slack of the various harness straps ( 61 - 66 ) is released by application of a pulling force on distal ends of respective various harness straps ( 61 - 66 ). In the exemplary embodiment of FIGS. 7-9 , the harness bag ( 100 ) is preferably made of a fire retardant material. The harness bag ( 100 ) stores and protects the harness ( 60 ) from adverse environmental conditions. The harness bag ( 100 ) facilitates storage of the harness ( 60 ) in an organized manner when in the non-deployed state, avoiding tangling and damage to the harness straps. The harness bag ( 100 ) can be used with harness frameworks, such as the harness system of FIG. 6 . It is to be appreciated that a harness with an integral harness bag, as shown in FIGS. 7-9 , may be utilized as a stand-alone rescue harness device, such as a full body harness, independent of a base panel as in rescue stretcher device applications. As a stand alone rescue harness system, the harness bag ( 100 ) serves as a container for any rescue harness device used in conjunction with the harness bag, to protect and provide stowage for the harness device, with the harness bag further serving to provide some level of back and upper torso support when the harness system with the integral harness bag is donned and deployed by an individual. In the exemplary embodiment shown in FIGS. 10A-C , 11 and 12 , a rescue device ( 400 ) is provided that includes a harness ( 420 ) with a plurality of harness straps and a harness bag ( 100 ) having an interior cavity (C) to contain the harness ( 420 ) when the rescue device ( 400 ) is in the non-deployed state. Each proximal end of each harness strap is secured within the harness bag ( 100 ) and the harness straps include shoulder straps ( 440 A, 440 B) and a waist strap ( 465 ), having respective distal ends ( 465 D 1 , 465 D 2 ) that each pass through respective slits (S 1 , S 2 ) in the harness bag ( 100 ) to extend outside of the harness bag ( 100 ). FIG. 10A shows only harness bag ( 100 ), with the rescue device ( 400 ) in the non-deployed state, in which excess slack of each harness strap is releasably secured within the harness bag ( 100 ) and distal ends of each harness strap are releasably secured on an exterior surface (E) of the harness bag ( 100 ). FIG. 10B shows the harness bag ( 100 ) secured to the base panel ( 10 ), with an interior cavity (C) of the harness bag ( 100 ) exposed. It is to be understood that for purposes of clarity, FIG. 10B does not show excess slack of the pull straps ( 492 , 494 ) and other straps. When in the non-deployed state, a majority of the length of the shoulder straps ( 440 A, 440 B), the waist strap ( 465 ), and the leg straps ( 470 , 480 ) are retracted into and stored within the interior cavity (C) of the harness bag ( 100 ), and are releasably secured using snaps or strap mechanisms, as discussed above. FIG. 10C shows only harness bag ( 100 ), with the shoulder straps ( 440 A, 440 B), the waist strap ( 465 ), and the leg straps ( 470 , 480 ) extracted from the harness bag ( 100 ). First and second connectors ( 466 , 467 ) are provided on the waist strap ( 465 ) with clips that are stored in fastener devices provided on an exterior surface (E) of the harness bag ( 100 ). The fastener devices are provided as pockets (P) preferably located in close proximity to respective slot (SL) in a top layer ( 102 ) of harness bag ( 100 ) that releasably hold in place distal portions of the harness straps ( 440 A, 440 B) when the harness ( 420 ) is in the non-deployed state. To deploy the rescue device ( 400 ), the distal ends of the harness straps ( 440 A, 440 B) are released from the exterior surface (E) of the harness bag ( 100 ) and the harness straps ( 440 A, 440 B) are extracted from within the harness bag ( 100 ) by pulling the harness straps ( 440 A, 440 B) through the respective slits (SL) in the harness bag ( 100 ). Accordingly, when the rescue device ( 400 ) is in a deployed state, an individual (I) being rescued is secured in the rescue device ( 400 ) by looping the harness straps ( 440 A, 440 B) around the individual (I) and interconnecting the distal ends of the harness straps. A reclosable opening (O) is provided in the harness bag ( 100 ) of the rescue device ( 400 ) to provide access to the interior cavity (C) of the harness bag ( 100 ) to repack the plurality of harness straps and return the rescue device ( 400 ) to the non-deployed state. A plurality of fasteners are disposed within the interior cavity (C) of the harness bag ( 100 ) to releasably secure excess slack of the plurality of harness straps ( 440 A, 440 B) within the interior cavity (C) of the harness bag ( 100 ) when the harness ( 420 ) is in the non-deployed state. The plurality of harness straps of the rescue device ( 400 ) also include leg straps ( 470 , 480 ), distal ends of which extend outside of the harness bag ( 100 ). The distal ends of the shoulder straps ( 440 A, 440 B) are preferably fixedly interconnected, such as by stitching each distal end to the shoulder strap connector ( 450 ), as shown in FIGS. 10A-C and 11 . Accordingly, an individual (I) being rescued is secured in the rescue device ( 400 ) by looping the harness straps around the individual (I) and connecting the distal ends ( 465 D 1 , 465 D 2 ) of the waist strap ( 465 ) to the interconnected distal ends of the shoulder straps ( 440 A, 440 B). The individual (I) is secured in the rescue device ( 400 ) by looping each leg strap ( 470 , 480 ) around respective legs of the individual (I) and securing distal ends of each leg strap (n/a) to respective connectors ( 472 , 482 ), i.e. first and second leg strap receivers, fixed to the exterior surface (E) of the harness bag ( 100 ). To facilitate use by a single rescuer, the base panel ( 10 ) of the rescue device ( 400 ) is preferably formed of a flexible, non-shape retaining, material. As shown in FIG. 12 , when in the non-deployed state, the base panel ( 10 ) is rolled in a lengthwise direction with the harness bag ( 100 ) contained therein, thereby providing a self-contained and easily transportable rescue device ( 400 ). As shown in FIGS. 10A-C , a plurality of pull straps ( 492 , 494 ) are provided having proximal ends thereof fixedly attached to the harness ( 420 ). When an individual (I) being rescued is positioned in the rescue device ( 400 ), the individual (I) and the rescue device ( 400 ) can be moved by pulling the pull straps ( 492 , 494 ). Accordingly, a method is provided for operating a rescue device ( 400 ), in which base panel ( 10 ) and a harness bag ( 100 ) of the rescue device ( 400 ) are unrolled, and distal ends of a plurality of harness straps are released from an exterior surface (E) of the harness bag ( 100 ). The plurality of harness straps include shoulder straps ( 440 A, 440 B), waist strap ( 465 ) and leg straps ( 470 , 480 ), with distal ends of the shoulder straps ( 440 A, 440 B) being fixedly interconnected. The individual (I) to be rescued is then placed on the exterior surface (E) of the harness bag ( 100 ), and the harness straps are extended from the interior cavity (C) of the harness bag ( 100 ) through respective slots (SL 1 , SL 2 ) in a top layer ( 102 ) the harness bag ( 100 ), with proximal ends of each harness strap remaining secured within the harness bag ( 100 ). The individual (I) is then secured in the rescue device ( 400 ) by looping the extended harness straps around the individual (I) and interconnecting distal ends of the harness straps, with shoulder straps ( 440 A, 440 B), a waist strap ( 465 ), with distal ends ( 465 D 1 , 465 D 2 ) of the waist strap ( 465 ) being connected to the interconnected distal ends of the shoulder straps ( 440 A, 440 B). When the rescue device ( 400 ) is in a non-deployed state, excess slack of each harness strap is releasably secured within the harness bag ( 100 ) and distal ends of each harness strap are releasably secured on an exterior surface (E) of the harness bag ( 100 ), thereby containing the harness straps in the harness bag ( 100 ). As shown in FIG. 11 , the shoulder harness ( 440 ) preferably includes two straps ( 440 A, 440 B) arranged to facilitate the individual's (I) head (H) therebetween. A shoulder strap connector ( 450 ) secures each of the straps of shoulder harness ( 440 ) at distal ends thereof. The shoulder strap connector ( 450 ) includes first and second waist strap receivers ( 452 , 454 ), preferably each being female part a quick release fasteners that also allow for rapid strap tensioning to accommodate different size individuals. The quick release fasteners remain closed when under load, such as AustriAlpin COBRA™ quick release stab-lock fasteners. Preferred embodiments also include fasteners disclosed in U.S. Pat. No. 4,937,923 to McEntire and in U.S. Pat. No. 7,073,235 to Benedict. Corresponding male ends of the quick release fasteners are provided on first and second ends ( 466 , 467 ) of the waist strap ( 465 ). As also shown in FIG. 11 , first and second leg straps ( 470 , 480 ) are also provided to each secure a leg of the individual (I). Distal ends of the first and second leg straps ( 470 , 480 ) each include a quick release fastener that connect to first and second leg strap receivers ( 472 , 482 ), respectively. Proximal ends of the plurality of leg straps ( 470 , 480 ), shoulder harness ( 440 ) and waist strap ( 465 ) are fixedly connected to a form a harness ( 420 ), with the first and second leg strap receivers ( 472 , 482 ), respectively. The harness ( 420 ) is removably coupled to a base panel ( 10 ) and includes pull straps ( 492 , 494 ) that pass through corresponding slots (SL 1 , SL 2 , FIGS. 8-9 ) of the base panel ( 10 ) to securely couple the harness ( 420 ) and the harness bag ( 100 ) to the base panel ( 10 ). FIG. 12 shows the drag stretcher device ( 400 ) in a storage state, being carried by a rescuer via carry handle ( 410 ). It is to be understood that the exemplary embodiments discussed here are merely illustrative of general conceptual frameworks of a rescue stretcher device or rescue sled having a flexible base panel combined with a harness, wherein the harness may include an integral harness bag for protection and stowage of the harness body straps. The harness according to exemplary embodiments of the invention can be designed for different applications and can include any type of harness systems such as full-body harnesses or rescue harness frameworks that otherwise meet NFPA (National Fire Protection Association) standards (or other regulatory standards) for Class I, Class II, and/or Class III service, depending on the application. Although illustrative embodiments of the present invention have been described herein with reference to the accompanying drawings, it is to be understood that the invention is not limited to those precise embodiments, and that various other changes and modifications may be affected therein by one skilled in the art without departing from the scope or spirit of the invention.

1a

This application takes priority from German Patent Application DE 10 2009 002 988.5, filed 11 May 2009, the specification of which is hereby incorporated herein by reference. BACKGROUND OF THE INVENTION 1. Field of the Invention One or more embodiments of the invention relates to an electromedical implant designed for determining P-wave dispersion. The electromedical implant can, for example, be an appropriately configured implantable pacemaker or an implantable cardioverter/defibrillator (ICD), or a combination of both. 2. Description of the Related Art Electromedical implants include a recording unit for recording an electrocardiogram signal. This recording unit is connected, or can be connected, to at least two electrodes for recording electric signals, which reflect the curve of an electrocardiogram signal of the right and left atria. In addition, the electromedical implant comprises a detection unit, which is designed to detect signal features characterizing atrial cardiac actions in an electrocardiogram signal. The latter is performed in known implantable pacemakers or ICD in that an intra-atrial electrocardiogram signal recorded in the atrium of a heart is permanently subjected to a threshold value comparison. If the amplitude of the intra-atrial electrocardiogram signal exceeds the threshold value, an atrial cardiac action is detected. Typically, an atrial sensing unit is provided for this purpose. The detection of an atrial cardiac action is also referred to an atrial sense event. The respectively detected electric signal is the result of a depolarization of the atrial muscle cells accompanying the contraction of the atrial myocardium. Detecting and evaluating the atrial dispersion are likewise known in principle. The P-wave dispersion describes the temporal distribution of the P-wave in the 12 leads of the surface electrocardiogram and is therefore an expression of atrial excitation propagation. If the P-wave dispersion value increases, it can be assumed that inhomogeneous atrial excitation formation and conduction are present. In particular atrial excitation initiated by several focuses prior to atrial arrhythmia causes inhomogeneous excitation of the atrium and consequently greater P-wave dispersion. P-wave dispersion therefore provides important diagnostic information for patients at risk of atrial arrhythmia. Since the coincidence of atrial fibrillation and the indication for an ICD are very high, this parameter is of tremendous importance for these patients. US 2005/0027321 A1 describes an apparatus which, among other things, can determine the morphology of the P-wave, including the duration thereof, and is also intended to record the dispersions of widths of the P-waves. The dispersion term is used slightly differently in US 2005/0027321 A1: here, the comparison of the variance of the P-wave width recorded over several consecutive P-waves is meant. P-wave dispersion described in the literature, however, in the 12-channel surface electrocardiogram is defined as a temporal “scattering” of a P-wave measured in the 12 leads of the surface electrocardiogram. This P-wave dispersion is therefore an expression of the atrial excitation formation and propagation. This is for example what is to be implemented with one or more embodiments of the invention in an electronic implant, without making an atrial electrode absolutely necessary as will be explained in the remainder of this disclosure. The study “Koide Y, Yotsukura M, Ando H, Aoki S, Suzuki T, Sakata K, Ootomo E, Yoshino H. “Usefulness of P-wave dispersion in standard twelve-lead electrocardiography to predict transition from paroxysmal to persistent atrial fibrillation.” Am J. Cardiol. 2008 Sep. 1; 102(5):573-7. Epub 2008 Jul 10” reports of the diagnostic values of P-wave dispersion derived from the 12-channel surface electrocardiogram. So far, it has not been possible to automatically capture this parameter in an ICD. BRIEF SUMMARY OF THE INVENTION It is the object of one or more embodiments of the invention to capture a parameter in an implantable device (such as ICD, pacemaker, heart rhythm monitor) that corresponds to the P-wave dispersion of the 12-channel surface electrocardiogram, thereby providing a predictive diagnostic value for managing patients with atrial fibrillation. The key in doing so in one or more embodiments is the exact determination of the earliest onset of atrial excitation and the end of atrial excitation. According to one or more embodiments of the invention, this object is achieved by an electromedical implant which comprises a far-field electrocardiogram capturing unit for recording a far-field electrocardiogram signal, wherein the unit is connected, or can be connected, to at least two electrodes for recording such electric signals which reflect the curve of a far-field electrocardiogram of the right and left atria. In addition, the electromedical implant according to one or more embodiments of the invention comprises a detection unit, which is designed to detect signal features characterizing atrial cardiac actions in an electrocardiogram signal. The electromedical implant further comprises an averaging unit, which is connected to the recording unit and the detection unit and designed to generate an averaged P-wave signal in that the averaging unit averages a plurality of signal sections of the far-field electrocardiogram signal associated with a particular detected atrial cardiac action. Finally, the electromedical implant comprises an evaluation unit, which is connected to the averaging unit and designed to determine the duration of an averaged P-wave in the particular averaged P-wave signal. The duration of a particular averaged P-wave reflects the dispersion of the P-wave. One or more embodiments of the invention is based on the realization that a far-field electrocardiogram signal, which is recorded by way of an implant and reflects the activities of both atria, is especially suited for analysis with respect to P-wave dispersion. In the implants known from the prior art, the analysis of P-waves is typically based on an intra-atrial electrocardiogram, which is recorded using an electrode having a relatively small surface in an atrium of a heart. Such electrocardiograms usually substantially reflect the activity of a single atrium, but not of both atria. The advantage of the solution according to one or more embodiments of the invention is that now the diagnostic information of P-wave dispersion can be captured in an electronic implant, such as a pacemaker, an ICD, or an implantable monitor. For this purpose, electrodes already present for the typical applications of such a device can be employed. Using this diagnostic information, patients with atrial fibrillation can be managed considerably better because now continuous monitoring the P-wave dispersion is possible and, for example, the time of a switch in medication or atrial fibrillation ablation can be anticipated and planned. This additional atrial diagnostics can also contribute to a more customized use of atrial fibrillation ablation and consequently lower the costs for the ablation procedure, which presently are still too high. Below, a few advantageous embodiments will be explained in detail. The detection unit for capturing atrial cardiac actions can be a conventional atrial sensing unit, which can be connected to a conventional atrial electrode. The detection unit, however, is preferably connected to the far-field electrocardiogram capturing unit and designed to detect atrial cardiac actions, for example on the basis of morphology criteria, or other criteria, in the far-field electrocardiogram recorded by the far-field electrocardiogram capturing unit. The latter variant has the advantage that it enables the P-wave dispersion to be captured and analyzed even for such implants which have no dedicated atrial electrode, these being single-chamber pacemakers or single-chamber ICDs, for example. The electrocardiogram supplied to the detection unit is preferably filtered. For this purpose, the implant preferably has a band pass filter, which is matched to the frequency range of the signals to be detected. In order to record a far-field electrocardiogram signal, the far-field electrocardiogram capturing unit is preferably connected at least to an electrically conductive part of a housing of the implant by way of a first electrode. For one, this allows a far-field electrocardiogram to be recorded, because the housing of the implant is located outside of the heart at a suitable distance. In addition, this variant eliminates the need to implant a separate electrode. Furthermore, it is preferred to connect the far-field electrocardiogram capturing unit to a defibrillation electrode on an appropriate electrode lead connected to the implant as the second electrode. Defibrillation electrodes are generally designed as shock coils and have a relatively large surface, compared to typical stimulation or sensing electrodes. An atrial shock coil is an electrode that is particularly well suited. By providing an electrode having a large surface as the second electrode for recording a far-field electrocardiogram, the electrocardiogram that is recorded is in fact a far-field electrocardiogram. The implant is preferably an ICD, connected to the usual electrodes. Specifically in this case (but also for other implants), the far-field electrocardiogram capturing unit can also be connected to atrial or ventricular ring or tip electrodes, which are known per se, for example the following configurations are possible: The broad band derivation of the far-field electrocardiogram for determining the P-wave signal is carried out between a distal shock electrode and the housing of an ICD. The broad band derivation of the far-field electrocardiogram for determining the P-wave signal is carried out between a proximal shock electrode and the housing of an ICD. The broad band derivation of the far-field electrocardiogram for determining the P-wave signal is carried out between a right ventricular ring electrode and the housing of an ICD or pacemaker. The broad band derivation of the far-field electrocardiogram for determining the P-wave signal is carried out between a right ventricular tip electrode and the housing of an ICD or pacemaker. It is also advantageous when the electrode configurations used for the broad band derivation of the far-field electrocardiogram for determining the P-wave dispersion can be manually switched or reprogrammed. Alternatively, it may be provided that that the respective electrode configuration used for the broad band derivation of the far-field electrocardiogram for determining the P-wave dispersion is automatically selected on the basis of an electrocardiogram signal quality analysis. The evaluation unit preferably comprises both a unit for determining a starting time of an averaged P-wave and a unit for determining an ending time of an averaged P-wave. These two units can also be provided separately from the evaluation unit and connected thereto. The evaluation unit is designed to determine the duration of an averaged P-wave as a time difference between the starting time determined by the one unit and the ending time determined by the other unit. These two units for determining the starting time and the ending time of an averaged P-wave are preferably designed such that in each case for individual detection parameters, such as signal amplification factor, threshold values, signals used, and the like, can be specified for them. The specification to be selected may also include evaluation of a defined electrocardiogram signal among several regarding the respective time. It is particularly advantageous when the averaging unit, the evaluation unit, or the unit for determining an ending time of an averaged P-wave is designed to subtract an isochronous ventricular electrocardiogram from a particular P-wave, or a signal section to be averaged, which is to say to subtract the amplitude of a synchronous ventricular electrocardiogram from the respectively corresponding amplitude of the P-wave or the signal section to be averaged. The averaging unit is preferably designed to average signal sections to be averaged with one another such that they are synchronized with one another over the respective points of time of the detection of an atrial cardiac action. The time of detection of a particular atrial cardiac action is therefore the reference time for averaging the signal sections with one another for all signal sections to be averaged. With respect to the averaging unit, the number of consecutive signal sections to be averaged can preferably be set. According to a preferred variant, the implant comprises a monitoring unit, which monitors a parameter that corresponds to the P-wave dispersion—which is to say, in particular the duration of the averaged P-waves determined by the evaluation unit—at regular intervals, preferably continuously or at least once a day. It is particularly advantageous to design the far-field electrocardiogram capturing unit such that at least two far-field electrocardiogram signals can be recorded simultaneously, as is explained below with respect to at least the final two figures of the specification described in the next section. According to a further advantageous variant, a broad band derivation of the far-field electrocardiogram for determining the P-wave dispersion is carried out by way of a right atrial, floating electrode (VDD principle). BRIEF DESCRIPTION OF THE DRAWINGS One or more embodiments of the invention will now be described in more detail with reference to an exemplary embodiment illustrated the figures. The figures show: FIG. 1 : a single-chamber ICD system as an example of an electromedical implant; FIG. 2 : an exemplary illustration of a P-wave in a far-field electrocardiogram; FIG. 3 : a block diagram of several components of an implant; FIG. 4 : an example of an implant in a remote transmission system; FIG. 5 : an example of a multichannel P-wave duration determination; and FIG. 6 : a multichannel detector for P-wave duration determination. DETAILED DESCRIPTION OF THE INVENTION As a possible embodiment, FIG. 1 shows a single-chamber ICD system. The housing 110 thereof, including the components provided therein, is connected to a flexible, implantable electrode lead 120 . At the distal end thereof, the lead has a bipolar perception and stimulation pole, comprising a right ventricular tip electrode 130 and a right ventricular ring electrode 140 . For delivering the defibrillation shock, a distal shock coil 150 , and optionally a proximal shock coil 160 , are provided at the electrode lead 120 as the respective defibrillation or shock electrode. The electrocardiograms required for the determination of the P-wave dispersion as claimed can in principle be derived from the following electrode combinations: Variant A: right ventricular tip electrode —ICD housing Variant B: right ventricular ring electrode —ICD housing Variant C: distal shock coil —ICD housing Variant D: proximal shock coil —ICD housing The preferred derivations, however, are variant D, if a proximal shock coil is present, and variant C, if no proximal shock coil is present, since in these derivations the imaging of the atrial excitation (P-wave) is the most favorable. Since several derivations are possible for determining the P-wave, in the exemplary embodiment a selection matrix is provided, which selects the most favorable derivation of the P-wave determination, either manually and programmably by the user, or automatically on the basis of electrode impedances and signal quality. In the version as a pacemaker, the illustrated shock coils 150 and 160 are eliminated. Instead, the electrocardiogram derivation is performed by way of an atrial pacemaker electrode (optionally tip electrode or ring electrode), or by way of a floating atrial electrode, which additionally is accommodated as a ring electrode on the feed line of the ventricular electrode (A+ or VDD principle). FIG. 2 shows the results of signal averaging for detection of a P-wave in the far-field electrocardiogram. The upper curve 210 shows an input signal having an amplitude of 0.1 mV in order to simulate a very small P-wave. In addition, the input signal is slightly noisy in order to simulate the actual conditions of the far-field electrocardiogram derivation. In the second curve 220 , the derivation of these P-waves in the far-field electrocardiogram is shown, derived with an ICD between the proximal shock coil and the housing of the ICD. The interference signals illustrated next to the P-wave do not allow any automatic P-wave detection by the ICD. In the third curve 230 , the signal is shown after it has been averaged over 24 cardiac cycles. Signal averaging is synchronized for a particular detected atrial cardiac action (atrial sense event). The atrial cardiac action in this embodiment is detected in an electrocardiogram which was recorded by the proximal shock electrode 160 and the housing of the implant 110 . Alternatively, a separate right atrial electrode can be used for atrial sensing. After 24 averagings (signal 230 ), the signal quality is already sufficient to be able to achieve automatic detection the P-wave, including the components thereof (right-left atria), in the ICD. Based on the sufficiently averaged signal 230 , it is now possible to determine parameters which correlate with the P-wave dispersion. The most important parameter is the duration (t) (also referred to as width) of the P-wave, which is determined in the implant and stored. If the derivation vector and number of averaged cycles are sufficient, the duration of the averaged P-wave corresponds to the P-wave dispersion from the 12-channel surface electrocardiogram. Further improvement in the diagnostic meaningfulness—particularly for unmasking several focuses of the atrial excitation—is achieved by counting the points of irregularities (S 1 . . . S 4 ) in the averaged P-wave 230 . FIG. 3 shows several components of an ICD, which is designed for a P-wave dispersion analysis described according to one or more embodiments of the invention, shown in the form of a block diagram. The ICD here is additionally connected to a right atrial perception and stimulation electrode 310 . The intracardiac electrocardiogram (IEGM) recorded (derived) with the help of this electrode is analyzed in a conventional ICD sensing stage 320 , and the detected atrial cardiac actions (atrial events, P-sense) are subsequently supplied to an ICD timer 330 for therapy control and rhythm diagnostic 340 . Not shown is the ventricular perception and stimulation channel, because it is not changed compared to the prior art for the implementation according to embodiments of the invention. The shock electrodes 391 and 392 connected to a shock generator 390 of the ICD, and the electrically conductive housing 300 of the ICD, are additionally connected to a far-field electrocardiogram selection matrix 350 . This selection matrix 350 establishes which of the electrodes are used for the derivation (recording) of a far-field electrocardiogram for the P-wave dispersion analysis. The selection is made either manually by programming by the physician, or automatically by a signal quality analysis conducted in the ICD ( 380 : “signal quality analysis”). This far-field electrocardiogram is subsequently preprocessed (amplified, digitized, filtered) in an electrocardiogram signal processing unit 360 and then fed to an average value forming device 370 as the averaging unit. The far-field electrocardiogram selection matrix 350 and the electrocardiogram signal processing unit 360 together form a far-field electrocardiogram capturing unit. The average value forming device 370 connected thereto conducts triggered signal averaging for a particular detected atrial cardiac action (atrial event 320 ), and supplies these averaged P-wave recordings to a morphology classifier 380 . This morphology classifier 380 measures these averaged P-wave with respect to the signal duration (signal width) thereof, optionally with respect to the number of points of irregularities and optionally other morphological characteristics. This information is then supplied to a diagnostic memory 340 , wherein an association with the atrial rhythm (330->340) is maintained. The information on the P-wave dispersion and on the atrial rhythm available in the diagnostic memory 340 can then be transmitted and displayed to the physician by way of near-field or far-field telemetry 321 . FIG. 4 shows an expanded overall system for continuous monitoring of the P-wave dispersion. Here, the electronic implant 410 described above is connected to a relay station or a base station 420 by way of RF telemetry (preferably in the MICS band) and periodically transmits this information relating to the absence of atrial fibrillation to this relay station 420 . This station in turn transmits the information via a data transmission network 430 to a remote monitoring server 440 to which the physician 450 has access, for example via Internet, and therefore has the option to care for the patient by telemedicine (such as drug monitoring, scheduling for ablation therapy). Optionally, following a renewed occurrence of atrial fibrillation, or a period during which the criteria for the verification of the absence of atrial fibrillation are not met, the implant can immediately send a message to the remote monitoring system, and the remote monitoring server then sends a special message to the attending physician (such as in the form of SMS, fax, e-mail, or particularly striking identification of the patient in the remote continuing care database). In order to ensure correct analysis of the classified rhythm by the physician, during the events classified as periods not free of atrial fibrillation a stored IEGM is also sent to the remote monitoring server. In FIG. 5 , a multichannel determination of the P-wave width (“dispersion”) is illustrated by way of example. In this example, a first far-field electrocardiogram derivation 510 is recorded and averaged, and simultaneously a second far-field electrocardiogram derivation 530 is recorded and averaged. Both far-field electrocardiogram derivations are selected such that the atrial electrocardiogram can be depicted well. In addition, the right ventricular (alternatively the left ventricular) derived intracardiac electrocardiogram 520 is also recorded. The P-wave duration is now determined such that the earliest onset 540 of atrial excitation is searched for in both averaged atrial derivations. Subsequently, the end 550 of the atrial excitation in the two averaged atrial electrocardiograms is determined. Since typically also the ventricular excitation is visible in the atrial far-field electrocardiogram, additionally the analysis window for the atrial excitations is limited to the back. For this purpose, the information from the ventricular IEGM is used. The atrial analysis window is limited at the earliest verifiable ventricular excitation 560 . FIG. 6 shows a multichannel detector for determining the P-wave width according to the method illustrated in FIG. 5 . This detector is connected to a right ventricular electrode ( 600 : RV), electrodes for a first far-field derivation ( 630 : FF 1 ), and electrodes for a second far-field derivation ( 660 : FF 2 ). The electrodes for the first far-field derivation can be, for example, the proximal shock coil of an ICD electrode and the ICD housing. The electrodes for the second far-field derivation can be, for example, the proximal ring of a coronary sinus electrode and the ICD housing. The right ventricular electrode connection is connected to a conventional sensing stage 610 for IEGM signal processing. This unit in turn forwards the processed IEGM signals to an R-wave detector, which is designed such that it detects the earliest onset of the R-wave and then forwards it to the connected R-wave width detector 690 . The two far-field connections 630 and 660 are connected to an electrocardiogram signal processing unit 640 and 670 , respectively. These electrocardiogram signal processing units 640 and 670 are designed such that they maximally amplify the atrial signals to be captured and subject them to broadband filtration, so that the entire atrial excitation can be captured. For the electrocardiogram signal processing of the first far-field channel 640 , other parameters can be set than for the electrocardiogram signal processing unit of the second far-field channel 670 . Optionally, the electrocardiogram signal processing units may contain algorithms, which conduct automatic beat-to-beat adjustment of the parameters in order to optimally capture the recorded electrocardiogram signals. The far-field electrocardiogram signal processing units are associated with a P-wave averaging unit 650 and 680 . These units average the atrial electrocardiogram over a defined number of cardiac cycles, wherein this number is either fixed and preset or automatically determined by a signal quality analysis (such as based on the evaluation of the signal-to-noise ratio). The results of the P-wave averaging ( 650 , 680 ) are likewise supplied to the P-wave width detector ( 690 ). This P-wave width detector then determines the duration of the P-wave in accordance with the description of FIG. 5 . It will be apparent to those skilled in the art that numerous modifications and variations of the described examples and embodiments are possible in light of the above teaching. The disclosed examples and embodiments are presented for purposes of illustration only. Therefore, it is the intent to cover all such modifications and alternate embodiments as may come within the true scope of this invention.

1a

FIELD OF THE INVENTION [0001] This application claims the benefit of U.S. provisional application No. 60/543,491 filed on Feb. 11, 2004. The invention relates to devices for treatment of sleep disordered breathing (SDB). More specifically, the invention relates to a device for detecting SDB events in the presence of a continuous positive airway pressure and determining an appropriate adjustment to the airway pressure in response to detected SDB events. BACKGROUND OF THE INVENTION [0002] The present invention relates to the diagnosis and treatment of partial or complete upper airway occlusion, a condition in which the upper airway collapses, particularly under the reduced pressure generated by inhalation. This is most likely to happen during unconsciousness, sleep or anesthesia. [0003] A particular application of the present invention is to the diagnosis and/or treatment of snoring and sleep apnea. Sleep apnea is characterized by complete occlusion of the upper airway passage during sleep while snoring is characterized by partial occlusion. An obstructive sleep apnea sufferer repeatedly chokes on their tongue and soft palate throughout an entire sleep period, resulting in lowered arterial blood oxygen levels and poor quality of sleep. It should be realized that although the following specification discusses sleep apnea in detail, the present invention also applies to the diagnosis and treatment of other forms of upper airway disorders. [0004] The application of continuous positive airway pressure (CPAP) has been used as a means of treating the occurrence of obstructive sleep apnea. The patient is connected to a positive pressure air supply by means of a mouth and nose mask, nose mask only or nasal prongs. The air supply breathed by the patient is at all times at slightly greater than atmospheric pressure. For example, therapuetic pressures will typically be within the range of 4 cmH 2 O to 20 cmH 2 O. It has been found that the application of continuous positive airway pressure (CPAP) provides what can be described as a “pneumatic splint”, supporting and stabilizing the upper airway and thus eliminating the occurrence of upper airway occlusions. It is effective in eliminating both snoring and obstructive sleep apnea, and in many cases is effective in treating central and mixed apnea. [0005] The airway pressure required for effective CPAP therapy differs from patient to patient. In order to discover the airway pressure which is most effective for a particular individual, the practice has been for the patient to undergo two sleep studies at an appropriate observation facility such as a hospital, clinic or laboratory. The first night is spent observing the patient in sleep and recording selected parameters such as oxygen saturation, chest wall and abdominal movement, air flow, expired CO 2 , ECG, EEG, EMG and eye movement. This information can be interpreted to diagnose the nature of the sleep disorder and confirm the presence or absence of apnea and, where present, the frequency and duration of apneic episodes and extent and duration of associated oxygen desaturation. Apneas can be identified as obstructive, central or mixed. The second night is spent with the patient undergoing nasal CPAP therapy. When apnea is observed, the CPAP setting is increased to prevent apneas. The pressure setting at the end of the sleep period, i.e., the maximum used, is deemed to be the appropriate setting for that patient. [0006] For a given patient in a given physical condition, various stages of sleep will require different minimum pressures to prevent occlusions. Furthermore, these various pressures will, in fact, vary from day to day depending upon the patient's physical condition, for example, nasal congestion, general tiredness, and effects of drugs such as alcohol, as well as the patient's sleeping posture. Thus the appropriate pressure found in the laboratory is necessarily the maximum of all these minimum pressures for that particular night and is not necessarily the ideal pressure for all occasions nor for every night. It will generally be higher than necessary for most of the night. [0007] Also, a patient must be able to operate a CPAP system to deliver appropriate airway pressure at home where their general physical condition or state of health may be quite different from that in the sleep clinic, and will certainly vary from day to day. The patient's physical condition often improves due to CPAP therapy. It is often the case that after a period of therapy the necessary airway pressure can be reduced by some amount while still preventing the occurrence of obstructive sleep apnea. [0008] The long term effects of CPAP therapy are unknown so it is desirable to keep the airway pressure as low as practicable, particularly if a patient requires long term treatment. Lower airway pressures also result in a lower face mask pressure which is generally more comfortable for the patient. It has been found that CPAP induces patients to swallow and this inducement to swallow can be reduced by lowering the airway pressure. Thus it is desirable to use the lowest practicable airway pressure that is effective in preventing airway occlusion during CPAP therapy for the comfort and possibly the long term safety of the patient. Also, a lower airway pressure requires less energy consumption and a less complex and therefore less expensive apparatus, which is also generally quieter. [0009] Low airway pressures are also desirable before and during the early stage of each sleep period as the increased comfort of an initially lower airway pressure allows the patient to more easily fall asleep. When a patient undergoing CPAP opens their mouth with pressurized air being forced through the nose, the pressured air exits out of the mouth producing an unpleasant sensation. This can occur when the patient puts on the mask connected to the pressured air supply before falling asleep and some patients will therefore leave the mask off for as long as possible and may in fact fall asleep without wearing the mask and therefore without the benefits of the CPAP therapy. [0010] In addition to the problems associated with administering CPAP therapy there exists the inconvenience and cost of diagnosis which may be undertaken by overnight observation at a sleep clinic or the like. Hence a simple means whereby a patient's apnea problem can be diagnosed at home without supervision is clearly desirable as well as a CPAP device which will deliver a continuously minimum appropriate pressure for substantially the entire period of therapy. [0011] Although diagnosis in a sleep clinic as outlined above is beneficial, it has some deficiencies. A patient is likely not to sleep in a fully relaxed state in an unfamiliar environment and a single night is insufficient to obtain a pressure setting that will be optimal in the long run. Thus home therapy at the pressure setting arrived at in this way is likely to be less than 100% effective on some occasions and higher than necessary for a substantial portion of the time. The cost and inconvenience of a sleep study in a hospital setting are to be avoided if possible. [0012] A skilled physician can usually recognize the symptoms of sleep apnea from questioning and examining a patient. Where no other indications are present there is very little risk in attempting nasal CPAP therapy without further testing as the treatment is fail safe and non-invasive. However, a very useful intermediate step would be to analyze the pattern of respiratory waveforms (e.g., pressure, flow or sound) over one or more full nights of sleep. Interpretation of these patterns together with questioning and examination will, in many cases, provide sufficient confirmation of apnea to prescribe nasal CPAP therapy. If nasal CPAP eliminates the symptoms of day time sleepiness (as assessed by the patient) and of apneic snoring patterns (as assessed by analysis of recorded respiratory sounds while on nasal CPAP), the treatment can be continued. Further check-ups can be conducted at intervals recommended by the physician. [0013] In the most general form of a CPAP treatment device, the intermediate step before the device attempts CPAP pressure increases is to analyze the patterns of the respiratory parameters that can be obtained from sensors, such as a pressure sensor or flow sensor. As those skilled in the art will recognize, these parameters include, in addition to acoustic rate of breathing, inhaled/exhaled air volume and inhaled/exhaled air flow rate, and provide comprehensive information for the physician to assess the patient's condition. This additional information, for example, generated by a pressure transducer, is available at additional cost and complexity. Similar information related to airflow may be estimated from the speed of or current supplied to the blower of the apparatus that is supplying the pressure to the mask in a system where pressure changes are generated by changing the speed of the blower. Examples of such an implementation are disclosed in commonly owned U.S. Pat. Nos. 5,740,795, 6,332,463 and 6,237,593, the disclosures of which are hereby incorporated by reference. [0014] The measurement of other parameters would provide further information to assist diagnoses, and the acoustic and/or other respiratory recordings described above can readily be used in conjunction with other monitors such as ECG and/or pulse oximetry. Suitable monitors are available to measure both these parameters in the home. The correlation between reduced oxygen saturation and apnea is sufficiently well established to infer oxygen desaturation from the confirmation of an apneic event. [0015] One index determined from these parameters is the Apnea Hypopnea Index. The Apnea Hypopnea Index (“AHI”) is an indicator of severity of a patient's sleep disordered breathing. The AHI is determined by adding the total number of apneas and hypopneas the patient experienced over a particular time period, such as during a sleep clinic study. Various forms of AHI index are known by those skilled in the art. [0016] However, in automated devices, sophisticated sensors and associated algorithms for detecting SDB events and determining an appropriate response to the detected events add a level of complexity to the device that may increase the cost, potentially making them too expensive for some patients. Thus there is a need for a device that can accurately adjust the therapeutic pressures in response to SDB events to alleviate the events but utilizing minimum hardware and minimized methodology for controlling the hardware. OBJECTS AND SUMMARY OF THE INVENTION [0017] It is an objective of the invention to provide a device that can detect SDB events and automatically and effectively determine an appropriate pressure response. [0018] It is an objective of the invention to provide such a device that minimizes the pressure treatment but assures the provision of a minimum level of support necessary to treat the patient. [0019] It is still a further objective to provide such a device with minimal components to ensure that it is inexpensive and cost-effective to develop and manufacture. [0020] The invention is a device for detecting SDB events and adjusting pressure to prevent such events on a session-by-session basis, such as night by night, rather than on a breath-by-breath basis. In the device, in a first session while providing a level of treatment pressure, an indicator of severity of SDB events is detected. For example, in the first session the device detects and records a total number of apneas and hypopneas. Preferably, the detection of such events does not result in a change to the treatment pressure during that session. In a subsequent session, the treatment pressure is adjusted based on what the device learned during the previous session. Thus, the historic SDB index from the previous session is compared to a threshold in a current session and the treatment pressure is currently adjusted based on the historic index. In other words, pressure changes in subsequent sessions may increase or decrease depending on the nature of the historic SDB indicator. For example, if the prior night's AHI is greater than a threshold of 8, the pressure is automatically increased for use during the new session. If the pressure is less than 8, the pressure may decrease or stay the same. In one embodiment, patterns in changes over several prior sessions, such as consecutive nights, are analyzed to automatically determine a pressure setting in a current session. For example, if the AHI is 0 for two consecutive nights, the pressure may be reduced for or in the next night's treatment. [0021] In the preferred embodiment of the invention, an AHI index is determined from a flow signal which is preferably calculated from speed of the blower or current to the blower without use of a differential pressure transducer type flow sensor. Similarly, it is preferred that no pressure sensor be used in the setting of the pressure in the mask. Such a configuration assists in meeting the objectives as previously described. Further aspects of the invention are described in more detail herein. BRIEF DESCRIPTION OF THE FIGURES [0022] To satisfy the recited objectives, a description of the invention is provided with reference to appended drawings that depict typical embodiments of the invention and are not intended to limit the scope of the invention, in which: [0023] FIG. 1 depicts the structure of an embodiment of a pressure treatment apparatus suitable for implementing the methods of the current invention; [0024] FIG. 2 is a flow chart of steps in a methodology for the control of a pressure treatment apparatus for making pressure adjustments during a treatment session based on apnea/hypopnea (AHI) indices taken from an earlier treatment session; [0025] FIG. 3 is a more detailed flow chart of steps in a methodology for the control of a pressure treatment apparatus to determine an AHI during a treatment session; and [0026] FIG. 4 is a more detailed flow chart of steps in a methodology for the control of the adjustment of pressure treatment in a subsequent session based upon an AHI taken during a prior treatment session. DESCRIPTION OF THE INVENTION [0027] In reference to FIG. 1 , mask flow is measured using a flow sensor 4 f and/or pressure sensor 4 p with a pneumotachograph and differential pressure transducer or similar device. A flow signal F(t) is derived and mask pressure is measured at a pressure tap using a pressure transducer to derive a pressure signal P mask (t). The pressure sensor 4 p and flow sensor 4 f have only been shown symbolically in FIG. 1 since those skilled in the art would understand how to measure flow and pressure. Flow F(t) and pressure P mask (t) signals are sent to a controller or microprocessor 6 which then determines how to adjust the blower. Alternatively, it is preferred that a flow signal f(t) and pressure signal P mask (t) be estimated or calculated in relation to the blower motor by monitoring power supplied to the motor and/or the speed of the motor as disclosed in U.S. Pat. Nos. 5,740,795, 6,332,463 or 6,237,593, without the provision of flow and pressure sensors as described above. [0028] The controller 6 is configured and adapted to implement the methodology described in more detail herein and may include integrated chips, a memory and/or other instruction or data storage medium. For example, programmed instructions with the control methodology may be coded on integrated chips in the memory of the device (e.g., firmware) or loaded as software. [0029] The pressure delivery device includes a blower 8 , which preferably is an impellor. The impellor 8 is controlled by a servo 10 , receives ambient air through an inlet 12 and delivers pressurized air through an outlet 14 defined by an air delivery conduit 16 and a mask 18 with an integrated exhaust vent 20 . The impellor, motor, and controller assembly define a blower assembly and are located within the blower housing 22 . Various switches 24 and displays 26 are provided in the blower housing. A number of sensors are provided within the blower to monitor, among other things, snore 28 , motor speed 30 , and motor current 32 . Various devices known in the art can serve as these types of sensors. A communication interface 34 allows data to be transferred between the apparatus and an external device, such as a computer or controller. [0030] Preferably, the device delivers a generally constant therapeutic level of continuous positive airway pressure (CPAP) during any given treatment session. However, consistent with the control principles of the invention as described herein, other types of pressure treatment may be implemented in the apparatus, such as bi-level CPAP treatment or other variants of natural patient-synchronized pressure changes. A. Control of Pressure Adjustments Based on Historic AHI Determinations [0031] As illustrated in FIG. 2 , the pressure treatment apparatus implements control based on historic AHI determinations. As shown in step 20 , airway pressure treatment is provided to the patient during a first treatment session. In such a session, in the absence of historic AHI, the pressure treatment level will be set to a default low or minimum level, or a level prescribed by a physician or clinician. Preferably, no adjustments to the treatment pressure are made to change the level of therapy in response to a current detection of an SDB event during the current session. During the treatment session, in step 22 , sleep disordered breathing events are detected and an index of these events is determined. Preferably, apnea and hypopnea events are detected and an AHI, the AHI being initialized for the current session, is incremented by the number of such detected events. In step 24 , a new or subsequent treatment session is initiated with the apparatus. In this subsequent session, a therapeutic level of the treatment is set automatically as a function of the SDB event related index that was determined in the prior treatment session. [0032] In the preferred embodiment of the invention, each of the previously described treatment sessions is a different night's treatment with the device. Thus, an AHI may be recorded during use of the treatment apparatus during a single night and saved at the conclusion of the session. This saved AHI may then be utilized to set the treatment pressure in the next use of the device, such as during the next night. To distinguish such sessions, the device may be configured to store the AHI on power down. Then it will utilize a previously recorded AHI, if it exists, in setting the treatment pressure after the device is powered on but before or as treatment is commenced. Alternatively, other schemes for ensuring the use of an AHI from a previously recorded session may be implemented. In one alternative scheme, date and/or time of every determined AHI from all sessions are recorded and stored. During a subsequent use, checking is performed for the most recent AHI. Similarly, this may be implemented by checking the date of an AHI against an internal clock to permit the use of a previous day's AHI in setting treatment pressure. [0033] While additional pressure treatment adjustments may be made in a current session based on a current AHI determination or on detection of an SDB related event, it is preferred that no such adjustments be made until a subsequent session. Similarly, the ramping of pressure from a low pressure up to the set therapeutic treatment pressure such that the patient can fall asleep before reaching the therapeutic level may also be implemented by the device. B. Determination of an Apnea Hypopnea Index (AHI) in a First Session [0034] As previously noted, the pressure treatment device preferably detects sleep disordered breathing events including apneas and hypopneas, by determining an Apnea-Hypopnea Index. Optionally, other SDB related indices may be used, for example, an apnea index, a hypopnea index or some other SDB related index. The preferred determination methodology is illustrated in the flow chart of FIG. 3 . At the beginning of a treatment session with the device, a current SDB index or AHI is reset or initialized in step 30 . During the delivery of pressure treatment, flow is continuously measured or determined in step 32 . With flow information or the flow signal (e.g., from a differential pressure transducer or derived from blower speed or power to the blower motor), measures of ventilation (e.g., an average flow determined over a period of time) are calculated in a step 34 . [0035] Preferably, these ventilation measures include a short term measure and a long term measure. In one embodiment, a suitable recent ventilation measure or a short term average may be a low pass filtered flow signal utilizing a low pass filter having a time constant which is short with respect to the duration of a breath, e.g., about 2 to 8 seconds. A suitable longer term ventilation or longer term average measure of flow may be a low pass filtered flow signal utilizing a low pass filter having a time constant which is long with respect to the duration of a breath, e.g., about 110 seconds. [0036] These ventilation measures, including a short term measure and a long term measure, are for purposes of comparing a more recent average measure with a longer term average. From the results of such a comparison, either apneas or hypopneas may be detected in steps 36 A and/or 36 B respectively. For example, in detecting a hypopnea, if the short term average measure falls below the longer term average such that it is less than 50% of the longer term average, a hypopnea may be tallied or detected. Similarly, if the short term average falls below the longer term average such that it is less than 20% of the longer term average, an apnea may be tallied or detected. [0037] In one embodiment of the invention an AHI scoring scheme may be implemented as follows: i. An apnea is scored if a 2 second moving average ventilation drops below 25% of a recent average ventilation (time constant=100 s) for at least 10 consecutive seconds, ii. A hypopnea is scored if an 8 second moving average drops below 50% but not more than 25% of the recent average ventilation for 10 consecutive seconds. [0040] Those skilled in the art will recognize other methods or modifications for detecting hypopneas or apneas and determining an AHI or an SDB index which will otherwise indicate severity in the patient's SDB symptoms. [0041] After detecting either an apnea or a hypopnea event, an AHI may be incremented in step 37 . After incrementing the AHI, the system determines whether the session has ended at step 38 . At this point, the system terminates at step 39 . If the session is ongoing, the system cycles back to step 32 to continue detecting apnea and hypopnea events and incrementing the AHI. [0042] The total of these detected apneas and hypopneas for any given session would make up the AHI used in the adjustment of treatment pressure in a subsequent session. Preferably, the AHI is determined by adding the total number of apneas and hypopneas the patient experienced over a treatment period covering a single night. Optionally, the AHI may be a function of time such as an average hourly AHI determined over the total time for any given treatment session with the device such as a period of sleep or a single night of sleep. C. Adjustment of Treatment Pressure in Response to AHI in a Subsequent Session [0043] As previously noted, preferably automated adjustments to the therapeutic level of the treatment pressure are only made or only take effect for treatment in a subsequent session or subsequent night of treatment based on an AHI determined in a prior session or previous night of treatment. That is, the automated dynamic pressure changes are on a night-by-night basis rather than a breath-by-breath basis. Thus, the device implements an algorithm for adjusting the treatment pressure in a subsequent session. For example, as illustrated in FIG. 4 , after starting a new or entering a treatment session in step 40 , the device may then evaluate a previously recorded AHI in an evaluation step 42 . Based on the detected AHI from a prior session a new treatment pressure will be set. Optionally, for a first use or first session, the AHI may have a default of 0 such that no changes to the treatment pressure will be implemented in the first session. Similarly, a default pressure setting for the first use may be a low non-therapeutic value (e.g., about 1-3 cmH 2 O) or some other physician or clinician set value in a therapeutic range of about 4-20 cmH 2 O. [0044] In evaluating the historic AHI in step 42 , if a prior session results in no detected apneas or hypopneas or only a few (e.g., AHI=0 or less than 8), no pressure changes will be implemented and the treatment pressure setting will remain from the prior session. Alternatively, for purposes of determining the minimum pressure necessary to prevent SDB, for an AHI of 0 or an AHI of less than 8 from the prior session, the device may lower the pressure in the new session. In lowering the pressure, the device may decrement the pressure by a fixed amount, (e.g., 0.25 cmH 2 O) which is preferably lower than the pressure increase although they may be the same. Thus, in setting the treatment pressure in step 44 , the new pressure for the current setting will be the pressure from the prior session less the fixed decrement amount. [0045] However, if the AHI from the prior session is greater than 0 or greater than some low non-adjustment range (e.g., 1-8 events), the treatment pressure will automatically increment upwards since such an AHI score is an indication of the need for an increase in treatment. Thus, based on the high AHI from the previous night, the treatment pressure can be increased by some increment. The treatment pressure increase is performed with the intent to decrease the AHI towards a clinically desirable level in the subsequent night. The ideal treatment pressure will decrease the AHI to a clinically desirable level but not be so far in excess of the minimum required pressure that it induces unnecessary discomfort. Therefore, the quantum of the incremental pressure increase may vary depending upon the perceived clinical severity of the AHI. For example, the choice of incremental pressure increase may reflect the clinical observation that a relatively small increment will induce a clinically significant change where the patient has a relatively low AHI (e.g., a pressure increment of 0.5 cmH 2 O for an AHI in the range of 5-19) while a relatively larger increment will be appropriate to induce a clinically significant change where the patient has a relatively high AHI (e.g., a pressure increment of 2 cmH 2 O for an AHI of 40 or higher). [0046] Referring to FIG. 4 , in the treatment pressure setting step 44 , the treatment pressure is automatically set for the new session to be the previous session's pressure setting plus the increment. The treatment pressure will then be delivered during the current session in step 46 and then, at step 48 , the system cycles back to step 30 ( FIG. 3 ) and again begins the process of determining a new AHI. The new AHI will affect the treatment pressure for the next session or treatment in the next night or future session. Such a scheme allows the device to adjust itself over an unlimited number of nights, while evolving with the needs of the patient. [0047] In one embodiment, other schemes of adjustment of the pressure may be based on patterns of the AHI over more than a single night, such as two or more nights. For example, the pressure may be lowered if the AHI has been 0 for two or more consecutive sessions. Similarly, pressure may be increased only if the AHI in more than one consecutive night, for example, 2 or 3 nights, suggests a need for an increase. Preferably, any decay in pressure over time is slower than the increase in pressure over time. [0048] Optionally, the device may be configured with an adaptation range that limits the changes to the treatment pressure that the device may automatically implement based on a previous night's AHI determination. The adaptation range may be a preset variable that is determined by a physician and preferably is not changed during the many treatment sessions with the user or patient. A default range may be set into the device in the absence of such a setting by a physician. For example, the physician may preset the adaptation range to a value of 10 cmH 2 O. When a pressure change is implemented by the device, the range is checked to make certain that any increments attempted by the device never exceed the original pressure setting of the physician by the amount of the range. Thus, if the pressure is set to 5 cmH 2 O for the first session with a patient, and the adaptation range is set to 10 cmH 2 O, any automated treatment pressure change that attempts to increment the treatment pressure beyond 15 cmH 2 O would be prevented. In addition, the device may be configured with an optional warning indicator to advise the patient or the physician of the attempted increase beyond the adaptation range. [0049] A device that implements the above-described treatment scheme would have many benefits for SDB patients. For example, utilizing the described algorithm would be more cost effective when compared to more complex detection and adjustment schemes. Also, since the device can adjust on a night-by-night basis, it can provide adaptation for seasonal changes that may affect the patient's condition. It can also adapt with the patient's disease progression. [0050] The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not as restrictive. The scope of the invention is, therefore, indicated by the appended claims and their combination in whole or in part rather than by the foregoing description. All changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope.

1a

FIELD OF THE INVENTION The invention relates generally to fastening devices and more particularly to a hair tie which is adapted to be placed in an encircling relation about a lock of hair such as a pony tail. BACKGROUND OF THE INVENTION Devices to fasten locks of hair in a pony tail, braids or dred locks are generally well known, but suffer from a number of drawbacks. Many hair ties have as their predominate tying feature some sort of elastic band that requires the user to loop and twist about a lock of hair. These hair ties are sometimes difficult to apply. In addition, some of the elastic band hair ties on the market have numerous small metal pieces on the elastic loop, which can pull out or damage the hair. Other hair ties require knots that must be tied by the user in order to properly secure the hair in a pony tail. Some are difficult to tie to the hair, and sometimes the user may need assistance from a second person to help attach the hair tie. In addition, certain hair ties are unreliable in that they fail to remain in place on the pony tail. This drawback requires the wearer to adjust the hair tie intermittently. Some hair ties also provide limited flexibility to adjust and allow the user to choose different amounts of hair that may be fastened by a single hair tie at any one time. Furthermore, certain hair ties do not permit the hair tie to be decorated in a way that enhances the appearance of the wearer. SUMMARY OF THE INVENTION It is accordingly a primary objective of the present invention to provide a hair tie which will avoid the drawbacks stated above. The present invention provides a new means of securing a lock of hair into a pony tail, braid or dred lock. The foundation for the hair tie is a generally planar, elongated element forming a loop strap that is sufficiently flexible to encircle a lock of hair in a belt-like fashion. By sufficiently flexible, it is meant that the elongated element may be made from one or more of a variety of material or fabrics including but not limited to suede, leather, polyester, silk, cotton or vinyl. A surface of fastening tape is attached to the inside face of the element or loop strap, and a corresponding surface of fastening tape is attached to the outside face of the loop strap. The loop strap encircles a lock of hair in a belt-like fashion, and the fastening tape surfaces detachably engage to secure the lock of hair into a pony tail, braid or dred lock. When the hair tie is in the proper position on the wearer's hair, decorative ornaments are visible to a third person. The ornaments may be placed on the outside face of the loop strap or attached to a loop strap tail. The loop strap tail is an extension of the loop strap. It provides another surface for mounting decorative ornaments such as beads, studs, rhinestones, jewelry, braided rope, ribbon, etc. The loop strap and loop strap tail also provide a surface to emboss or print names or logos. In this manner, the hair tie may be decorated to the preference of the user. The fastening tape surfaces attached to the inside and outside faces of the loop strap preferably comprise fibrous loop and hook fastening material respectively. For purposes of this specification, the "hook fasteners" and "fibrous loop fastening material" should be understood as designating fasteners of the same general type as those distributed under the trademark Rip 'N Grip™. Similar fastening material is sold under the trademarks VELCRO, SCOTCHMATE and MASTEX. Preferably, secured on the inside face of the loop strap is a surface of fibrous loop fastening material, or female fastening tape. When the female tape wraps around a lock of hair, the tape connects with a surface of hook fasteners, or male fastening tape, secured to the outside face of the loop strap. A characteristic of the fastening tape allows the inside face of the loop strap to engage any of various selectable locations on the outside face of the loop strap, thereby permitting the hair tie to tie a lock of hair that may vary considerably in size. Embodiments of the invention desirably contain a combination of features that improve the functional characteristics and aesthetic appeal of the invention. For example, one embodiment of the invention may comprise the generally planar, elongated element or loop strap having an inside face and an outside face; an elastic loop secured to the inside face of the loop strap; and a surface of loop fastening tape attached to the inside face of the element or loop strap, and a corresponding surface of hook fastening tape is attached to the outside face of the loop strap. The lock of hair to be tied threads through the elastic loop, which holds the hair in position until the loop strap ties the hair. To tie the hair, the loop strap encircles the lock of hair in a belt-like fashion, and the fastening tape surfaces detachably engage to secure the lock of hair into a pony tail, braid or dred lock. An alternate embodiment of the invention may comprise the generally planar, elongated element or loop strap having an inside face and an outside face; a friction pad attached to the inside face of the loop strap; a surface of loop fastening tape attached to the inside face of the element or loop strap; a corresponding surface of hook fastening tape attached to the outside face of the loop strap; and a stiffening element secured to the loop fastening tape in a sandwich-like manner between the loop fastening tape and the inside face of the loop strap. The hair tie encircles the lock of hair in a belt-like fashion, and the fastening tape surfaces detachably engage to secure the lock of hair into a pony tail, braid or dred lock. The friction pad provides a surface which grips the lock of hair after the loop strap has encircled the lock of hair. The friction pad prevents the hair tie from slipping from the desired position on the lock of hair. The stiffening element has the capability of being deformed and maintaining its deformation. The stiffening element provides increased stability and forming capabilities to an end portion of the loop strap and allows the user to "tie" different amounts of hair on any one occasion. When only a small portion of the hair is encircled by the hair tie, a portion of the loop fastening tape may extend beyond and not engage the area of the male fastening tape and make the hair tie appear "unfinished". To prevent this "unfinished" look, the stiffening element allows the wearer to mold the extended end of the hair tie around the hair tie. The stiffening element enables the loop strap to maintain its molded shape. This gives the hair tie a finished look on the hair, rather than the extended end of the loop strap sticking straight out. Preferably, the stiffening element is flexible metal foil such as aluminum. Alternatively, other types of metal foil such as tin or a wire mesh, such as that used in window screens, or plastic may be used in place of the aluminum foil. The preferred embodiment the invention includes a first layer of a generally planar thin resilient reinforcing element having adhesive laminated on both sides, a second layer of a generally planar, elongated member adhered to one side of the reinforcing element, a thin stiffening element adhered to one end of the other side of the reinforcing element and a friction pad adhered to the reinforcing element adjacent to the stiffening element. The friction pad includes a hole for passing an elastic loop therethrough and capturing the ends of the elastic loop. Fibrous loop fastening tape attaches to the stiffening element and detachably engages with hook fastening tape attached to the opposite end of the reinforcing element on the fabric side. The resilient reinforcing element adheres to one side of the generally planar, elongated member. The member is sufficiently flexible to allow the hair tie encircle a lock of hair in a belt-like fashion. By sufficiently flexible, it is meant that the member may be made from one or more of a variety of material or fabrics including but not limited to suede, leather, polyester, silk, cotton or vinyl. The reinforcing element provides the overall support to the hair tie and provides a surface on which all other components directly or indirectly are attached. The reinforcing elements is resilient so that it will not distort the circular shape of the loop strap as it encircles the hair. Preferably, the reinforcing element is a polyester film characterized by high tensile strength, such as mylar™. A stiffening element is interposed between the female fastening tape and reinforcing element. The stiffening element has the capability of being deformed and maintaining its deformation. The stiffening element provides increased stability and forming capabilities to an end portion of the loop strap and allows the user to "tie" different amounts of hair on any one occasion. When only a small portion of the hair is encircled by the hair tie, a portion of the female fastening tape may extend beyond and not engage the area of the male fastening tape and make the hair tie appear "unfinished". To prevent this "unfinished" look, the stiffening element allows the wearer to mold the extended end of the hair tie around the hair tie. The stiffening element enables the loop strap to maintain its molded shape. This gives the hair tie a finished look on the hair, rather than the extended end of the loop strap sticking straight out. Preferably, the stiffening element is flexible metal foil such as aluminum. Alternatively, other types of metal foil such as tin or a wire mesh, such as that used in window screens, or plastic may be used in place of the aluminum foil. A friction pad attaches to the area of the reinforcing element adjacent to the stiffening element. The friction pad provides a surface which grips the lock of hair after the loop strap has encircled the lock of hair. The friction pad prevents the hair tie from slipping from the desired position on the lock of hair. An elastic loop extends through a hole in the friction pad. The elastic loop holds the hair firmly in place before the loop strap encircles the lock of hair. The ends of the elastic loop are desirably interposed between the friction pad and the reinforcing element and are held in place by the friction pad and adhesive. To use the invention, the wearer gathers an amount of hair desired to be held in a pony tail, braid or dred lock and threads it through the elastic loop until the hair tie is in the desired position on the hair. The hair is initially held in place by the elastic loop. Then, the wearer encircles the hair with the loop strap in a belt-like fashion so that the corresponding pieces of fastening tape attached to the hair tie detachably engage. The fastening tape connection resists forces in a plane substantially parallel to the connection securely holding the hair in place. However, the male and female pieces of the fastening tape that form the connection may be easily separated by normal peeling forces. The friction pad encircles a substantial portion of the pony tail and prevents the hair tie from slipping from its intended position on the pony tail. The circumference of the hair tie can be selectively varied since the ends of the hair tie may engage each other at various selectable locations. The selectable locations that the ends engage depend on the amount of hair that is being tied and how tight the wearer desires the hair tie. When a small amount of hair is tied into a pony tail, a portion of the female fastening tape may extend beyond and not engage the male fastening tape, causing the end of the hair tie to stick out and appear "unfinished." If this occurs, the user is able to mold the extended end of the hair tie around the hair tie to finished appearance. give the hair tie a finished appearance. When the hair tie is in the proper position on the wearer's hair, decorative ornaments are visible to a third person. The ornaments may be placed on the fabric portion of the hair tie or attached to a tail. The tail is an extension of the hair tie. It provides an additional surface for mounting decorative ornaments such as beads, studs, rhinestones, jewelry, braided rope, ribbon, etc. The hair tie and tail also provide a surface to emboss or print names or logos. In this manner, the hair tie may be decorated to the preference of the user. The hair tie may be made in various sizes to allow the user flexibility in the arrangement of his or her hair. For example, large hair ties may be used to hold in place one large pony tail, comprising substantially all of the user's hair. Alternatively, the user may elect to use numerous smaller sized hair ties to arrange his or her hair in smaller pony tails. In this manner, the user may decorate his or her hair with various hair ties in a variety of positions. It is a feature of the invention to provide a hair tie capable of tying different sizes of hair locks. Therefore, a person can put all of his or her hair in one single hair tie, or multiple smaller locks of hair, each into a separate hair tie. It is an object of the invention to provide a flexible closure device for hair, principally for use with and to hold hair in "pony tails". The invention may be constructed using any variety of fabrics and materials such as suede, leather, polyester, silk, cotton and vinyl. In addition, an advantage of the invention is that the hair tie that does not use knots but enables the user to securely fasten the hair tie around a lock of hair. The hair tie is easy to apply and remove from the hair and securely holds the hair in a pony tail. Of particular advantage is the fact that each end of the hair tie is detachably connected to the other. The connection resists forces in a plane substantially parallel to the connection securely holding the hair in place. However, the connection may be easily separated by normal peeling forces. Furthermore, it is another feature of the invention to provide a hair tie which not only is capable of efficiently securing hair, but also is an attractive fashion accessory. The hair tie may be furnished with decorative pins, beads, decorative fabrics or other ornaments. Other aspects of the invention will be apparent from a description of certain preferred embodiments below and will be more specifically identified in the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is an elevation view illustrating one side of an embodiment of the invention; FIG. 2 is an elevation view illustrating the opposite side of the embodiment of FIG. 1; FIG. 3 is an exaggerated plan view of the layered components of the embodiment of FIG. 1; FIG. 4 is an isometric view illustrating assembly of a single unit of the embodiment of FIG. 1; FIG. 5 is an elevation view illustrating one side of an alternate embodiment of the invention; FIG. 6 is an elevation view illustrating the opposite side of the embodiment of FIG. 5; FIG. 7 is a view illustrating the assembly of a roll of the foil subassembly; FIG. 8 is a view illustrating the assembly of a roll of the friction pad subassembly; FIG. 8A is a view of a roll adhesive showing the wax paper sections; FIG. 9 is a view illustrating the assembly of a roll of the reinforcing element subassembly; FIG. 10 is a view illustrating the assembly of a roll of the final product; FIG. 11 is a view illustrating the process of die cutting the invention from a roll of the final product of FIG. 10; FIG. 12 is a view of a partially assembled alternate embodiment of the invention, after the process of FIG. 11; FIG. 13 is a plan view illustrating the placement of the embodiment of FIG. 5 onto a lock of hair; and FIG. 14 is a view depicting the embodiment of FIG. 5 functioning in its stated purpose. DETAILED DESCRIPTION Referring to FIGS. 1 through 3, the foundation for the loop strap hair tie 11, as a unit, is a generally planar rectangular-shaped strap 13. Alternatively, the invention may include a tail 30 attached to the rectangular-shaped strap 13 as illustrated in FIGS. 5 and 6. By saying that the tail 30 is "attached" to the loop strap 13, it is meant either that the loop strap 13 and tail 30 are constructed from a continuous piece of fabric or material or that the loop strap 13 and tail 30 are constructed from separate pieces of fabric or materials and fastened together at abutting edges in generally coplanar orientation. The hair tie 11 may be assembled using one or more of a variety of materials or fabrics including, but not limited to, suede, leather, polyester, silk, cotton or vinyl. Referring to FIG. 1, the hair tie 11 is rectangular in shape with rounded corners. Generally, the overall size range of this embodiment is approximately 3 to 5 inches long and between about 1 and 11/2 inches wide. The exact size of the hair tie 11 is determined by the intended range of the amount of hair to be tied by the hair tie. For example, the hair tie 11 is longer for large amounts of hair to be tied and shorter for smaller amounts of hair to be tied. The construction of a single hair tie 11 is detailed in FIGS. 3 and 4. The dimensions that follow are for illustrative purposes only and are not intended to limit the size of the invention. As mentioned, the size of the invention is dependent upon how much hair the hair tie is intended to tie. The supporting structure of the invention is a generally planar thin resilient reinforcing film 26 having adhesive 32 laminated on one side. Preferably, the reinforcing film 26 is a polyester film characterized by high tensile strength, such as Mylar™ that may be purchased from the Dupont Company in Bloomington, Del. The reinforcing film 26 may be any of a variety of thicknesses, but preferably it is about 0.003 inches thick. The reinforcing film 26 encompasses the entire surface area of the hair tie 11 and in this example is cut to be 5 inches long by 13/8 inches wide. The reinforcing film 26 provides a surface on which all the other components mount directly or indirectly. The preferred adhesive 32 is catalog number 9460 manufactured by the 3M Company, Minneapolis, Minn., which is a sheet of adhesive material supplied with a wax paper backing 33 (not shown) on both sides of the adhesive. The adhesive 32 is cut to the same size as the reinforcing film 26 and laminated to one side 34 of the reinforcing film 26 using pressure. A layer of fabric 14 is laminated by pressure to the adhesive side 34 of the reinforcing film 26. The fabric 14 may be any of a variety of fabrics and materials such as suede, leather, polyester, silk, cotton and vinyl. The fabric is the same width as the reinforcing film 26, but is cut 1/2 inch shorter than the reinforcing film 26. In this example, the fabric 14 is 41/2 inches long and 13/8 inches wide. The fabric 14 is laminated to the reinforcing film 26 so that one end of the fabric 14 corresponds to one end of the reinforcing film 26. Attached to the remaining surface of reinforcing film 26 on side 34 is hook fastening tape 16. The hook tape 16 is 1/2 inch long and 13/8 inches wide. The hook fastening tape 16 is a surface consisting of multiple rows of hook fasteners, preferably catalog number 5400, supplied by Rip 'N Grip Industries, Chatsworth Calif. This specific fastening tape is preferred because it has a high density of hooks per square inch, thus providing increased connecting properties over a small amount of contacting surface area. Also, an additional advantage of this fastening tape is that it is less apt to catch the wearer's hair when the hair tie is fastened. On the adjacent side 35 of the reinforcing film 26, a stiffening element 28, the loop fastening tape 18, a friction pad 20 and an elastic loop 22 is attached to the reinforcing film 26. The stiffening element 28 must be flexible so that it may be easily shaped and yet maintain its deformation. In the preferred embodiment, the stiffening element 28 is aluminum foil #1100 soft and 0.006 inches thick. It is manufactured by A. J. Oster, 22833 La Palma Avenue, Yorba Linda, Calif. In this example, the size of the stiffening element 28 is 11/2 inches long by 13/8 inches wide. Alternatively, other types of metal foil such as tin or a wire mesh, such as that used in window screens, may be used in place of the aluminum foil. A foil subassembly 36 comprises the stiffening element 28 and the loop fastening tape 18. Adhesive 32, cut to the same size as the stiffening element 28, is laminated on both sides of the foil 28 using pressure. On one side of the foil 28, the loop fastening tape 18, which is also cut to the same dimensions as the stiffening element of 28, attaches to the stiffening element 28. The loop fastening tape 18 is a surface consisting of a fibrous loop fastening material, preferably, catalog number 4600, also supplied by Rip 'N Grip Industries. This subassembly 36 then adheres to one end of the reinforcing film 26 as shown in FIG. 4. A friction pad subassembly 38 comprises the friction pad 20 having adhesive 32 laminated on one entire side and an elastic loop 22 passing through a hole 24 in the friction pad 20. The friction pad subassembly 38 adheres to the remaining surface area of the reinforcing film 26, adjacent to the foil subassembly 36. Preferably, the friction pad 20 is a foam pad, 0.062 inches neoprene sponge-hard, manufactured by Rubatex Corporation, Bedford, Va. This foam pad is preferred since it provides a non-slip surface and is flexible and supple to allow the hair tie 12 to mold around the hair. Alternatively, the friction pad 20 may be made from other rubber-type substances, such as neoprene, so long as it provides a non-slip surface and is flexible. In this illustration, the foam pad 20 is cut to be 31/2 inches long by 13/8 inches wide. The friction pad 20 includes a hole 24, about 3/16ths of an inch in diameter, for passing an elastic loop 22 therethrough and capturing the ends 23 of the elastic loop. The hole 24 is centrally located in the friction pad 20 and about 13/8ths inches from the end of the friction pad 20 as shown in FIG. 2. The size of the elastic loop 22 varies depending on the amount of hair that the hair tie 11 can hold in a pony tail. Generally, the overall length of the elastic loop 22 and ends 23 ranges from approximately 3 to 51/2 inches in length and approximately 1/8th of an inch in circumference. The size of the loop ranges from approximately 1 to 2 inches in length and has approximately a 190-200 percent elastic stretch. The preferred elastic may be purchased from United Stretch Design, 90 Cherry Street, Hudson, Mass, 01749. The elastic loop 22 passes through hole 24 so that the loop ends 23 adhere to the adhesive 32 laminated to the friction pad 20. FIGS. 5 and 6 represent two views of an alternate embodiment of the invention. This alternate embodiment is the hair tie 12 having a tail 30 extending from the bottom long edge of the rectangular-shaped strap 13. The actual length of the tail 30 is not critical, but generally its length ranges from about 1 to 2 inches wider at its peak than the width of the rectangular-shaped strap 13. The assembly of this embodiment is similar to that of the embodiment of FIGS. 1 and 2 except that all the components are sized to correspond to the added dimensions of the tail 30. The tail 30 provides a surface for mounting decorative ornaments 44 such as beads, studs, rhinestones, jewelry, etc. The tail 30 also provides a mounting surface for an optional tailpiece 40 for decoration, which may be a string of beads or braided fabric, ribbon, etc. as illustrated in FIGS. 5 and 14. The hair tie and tail also provide a surface to emboss or print names or logos. In this manner, the hair tie 12 may be decorated to the preference of the user. Alternatively, the hair tie 12 may be made in any of various shapes that incorporate the features previously described. For example, the hair tie 12 could be shaped in accordance with holidays or observances, such as a heart for Valentine's Day. A preferred method of assembly enables mass production of the hair tie 12. The method of mass production takes advantage of the layered construction of the components comprising the hair tie 12 and the fact that each component may be purchased in considerable lengths supplied in rolls. FIG. 7 illustrates the method to assemble a roll 54 of the foil sub-assembly 36 from rolls of the individual components that comprise the foil sub-assembly 36. Rolls of the loop fastening material 48, adhesive 50A, foil 52 and adhesive 50 are aligned in the stated respective descending order in a common vertical plane and attached to spools that rotate at a single constant linear speed. The common vertical plane alignment causes the loop fastening material 18, adhesive 32, stiffening element 28 and adhesive 32 to be aligned in the required corresponding layers. The wax paper 33, is not shown, is removed from both sides on adhesive roll 50A, but the wax paper 33 on adhesive roll 50 is only removed on the face that attaches to the foil 28 unwinding from the foil roll 52. The ends of the rolls are threaded between rollers 72 that form nip 70. The pressure of nip 70 causes the adhesive to adhere to each component and the resulting product from the nip winds onto a pickup spool as foil sub-assembly roll 54. The pickup spool travels at the same linear speed as rolls 48, 50, 50A and 52. FIG. 8 illustrates the method to assemble a roll 58 of the friction pad sub-assembly 38 from rolls of the individual components that comprise the friction pad sub-assembly 38. Rolls of the foam material 56 and adhesive 50, are aligned in the respective descending order in a common vertical plane and attached to spools that rotate at a single constant linear speed. The wax paper 33 on adhesive roll 50 is only removed on the face that attaches to the foam 20 unwinding from the foam roll 56. FIG. 8A illustrates the wax paper 33 on the opposite face slit 63 in one lengthwise location to allow staged removal of wax paper sections 57 and 59 later in the process. The ends of each roll are threaded between rollers 72 that form nip 70. The pressure of nip 70 causes the adhesive to adhere to the foam 20 and the resulting product from the nip winds onto a pickup spool as friction pad sub-assembly roll 58. The pickup spool travels at the same linear speed as rolls 56 and 50. FIG. 9 illustrates the method to assemble a roll of a reinforcing film sub-assembly 62 from a foil sub-assembly roll 54, a foam pad sub-assembly roll 58, a roll of reinforcing film 60 and a roll of adhesive 50. Rolls 58 and 54 are aligned in the same horizontal plane so they are laminated on the reinforcing film 26 adjacent to each other in the same horizontal plane as shown in FIG. 4. Also, roll 58 is aligned as such so that wax paper section 59 is adjacent to roll 54. The remaining wax paper surface 33 on roll 54 is removed and wax paper section 57 on roll 58 is removed. Wax paper sections 57 and 59 remain on the foam 20 for removal later in the process. The wax paper 33 on the adhesive roll 50 facing the reinforcing film 26 is removed and the wax paper 33 on the opposite face remains on the adhesive 32. Rolls 58 and 54, aligned in a in a horizontal plane, are aligned in a common vertical plane with rolls 60 and 50 in the stated descending order. The ends of each roll are threaded between rollers 72 that form nip 70. The pressure of nip 70 causes the adhesive to adhere to each component and the resulting product from the nip winds onto a pickup spool as reinforcing film sub-assembly roll 62. As a result of the wax paper section 59 remaining on the adhesive 32, a portion of the foam sub-assembly 38 does not adhere to the reinforcing film 26. FIG. 10 illustrates the process of attaching the decorative fabric 14 and hook fastener 16 onto the reinforcing film sub-assembly 62. Decorative fabric roll 66 and hook fastener roll 64 are aligned in the same horizontal plane so they are laminated onto the reinforcing film sub-assembly 62 adjacent to each other in the same horizontal plane as shown in FIG. 4. The remaining wax paper 33 on the outside face of the reinforcing film sub-assembly roll 62 is removed. Rolls 66 and 64, aligned in a horizontal plane, are aligned in a common vertical plane with roll 62 in the stated descending order. The ends of each roll are threaded between rollers 72 that form nip 70. The pressure of nip 70 and exposed adhesive 32 causes the fabric 14 and hook fastener 16 to adhere to the reinforcing film sub-assembly and the resulting product from the nip winds onto a pickup spool as finished product roll 68. FIG. 11 illustrates the finished roll 68 feeding into a die cutter 74 via feed rolls 76. The die cutter stamps out individual hair ties 12 without an elastic loop 22. The individual hair tie 12 is deposited into a finished goods hopper 78 and the scrap is deposited into scrap hopper 80. The advantages of this die-cutting method is that it allows mass production of a uniform hair tie 12. Additionally, the die-cutting method gives the flexibility to vary easily the shape and appearance of the hair tie 12. Die patterns may be easily manufactured in various shapeps that will emboss emblems, names, etc. on the hair ties 12, or produce cutouts in the hair tie. As currently practiced, hole 24A through foam 20A is formed using a punch in a hand operation. Hole 24 is punched-out in the area of wax paper section 57. After hole 24A is punched in the foam 20, wax paper section 59 may be peeled away, exposing adhesive 33. The elastic loop 22A is inserted through the hole 24A so that the loop 23A, not shown will adhere to the adhesive 32A. The loop 23A, not shown are sandwiched between the foam 20A and reinforcing film 26 and securely held in place by the adhesive 32A. Additionally, before the foam pad 20A attaches to the reinforcing film 26A, a tail piece 40 may be attached to the tail area 30 by placing a portion of the tail piece 40 between the foam pad 20A and reinforcing film 26A so that the adhesive 32A holds the tail piece 40 in place. Optionally, the tail piece 40 may be attached to the tail 30 by attaching a post, similar to those found on pierced earrings, to the tail piece 40 and inserting the post through a pin hole in the fabric layer 14A and reinforcing film 26A. After inserting the post in the pin hole, the post is bent to secure the tail piece 40 in place. The bent post is sandwiched between the foam pad 20A and reinforcing film 26A and held in place by adhesive 32A. Alternatively, the tail piece 40 may be attached to the fabric layer 14 using adhesive. As shown in FIG. 13, elastic loop 22A encircles a lock of hair 42 and initially holds the hair in place. The hair tie 12 wraps in the direction of arrow 46 around the lock of hair 42 in a beltlike fashion until the loop fastening tape 18A faces and detachably engages the hook fastening tape 16A, attached to the outside face of the hair tie 12. Depending upon the amount of hair being tied and how tight the wearer desires the hair tie 12, the loop fastening tape 18A can engage the hook fastening tape 16A at various selectable locations. The fastening tapes 16 and 18, when fastened together, strongly resist relative longitudinal movement, but, may be separated from one another by peeling the surfaces apart. If a portion of the loop fastening tape 18A extends beyond and does not engage the hook fastening tape 16A the stiffening element 28 allows the extended end to be molded around the hair tie 12 to give the hair tie 12 a finished look. The friction pad 20A maintains the hair tie 12 in position on the lock of hair. After the hair tie is properly positioned on the lock of hair 42, decorative ornaments 44, located on the outside face of the hair tie, face outwardly from the pony tail as illustrated in FIG. 14. The decorative ornaments 44, along with an optional tailpiece 40 and imprinted names, are visible to others. Modifications and changes from the specific form of the invention herein shown and described as a preferred embodiment will occur to those skilled in the art. All such modifications and changes not departing from the spirit of the invention are intended to be embraced within the scope of the appended claims.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to shell separation devices and more particularly pertains to a clam and oyster opener for separating the shells of a clam or oyster. 2. Description of the Prior Art The use of shell separation devices is known in the prior art. More specifically, shell separation devices heretofore devised and utilized are known to consist basically of familiar, expected and obvious structural configurations, notwithstanding the myriad of designs encompassed by the crowded prior art which have been developed for the fulfillment of countless objectives and requirements. Known prior art shell separation devices include U.S. Pat. No. 5,178,577; U.S. Pat. No. 4,870,719; U.S. Pat. No. 4,787,123; U.S. Pat. No. 3,886,628; and U.S. Pat. No. 3,683,458. While these devices fulfill their respective, particular objectives and requirements, the aforementioned patents do not disclose a clam and oyster opener for separating the shells of a clam or oyster which includes a base plate having a support channel for receiving and supporting an oyster, and a lever arm pivotally mounted to the base plate and including an engaging tip secured to the lever arm and positioned for engagement with the oyster residing within the support channel to effect cracking and opening of the oyster. In these respects, the clam and oyster opener according to the present invention substantially departs from the conventional concepts and designs of the prior art, and in so doing provides an apparatus primarily developed for the purpose of separating the shells of a clam or oyster. SUMMARY OF THE INVENTION In view of the foregoing disadvantages inherent in the known types of shell separation devices now present in the prior art, the present invention provides a new clam and oyster opener construction wherein the same can be utilized for opening the shell of a clam or oyster. As such, the general purpose of the present invention, which will be described subsequently in greater detail, is to provide a new clam and oyster opener apparatus and method which has many of the advantages of the shell separation devices mentioned heretofore and many novel features that result in a clam and oyster opener which is not anticipated, rendered obvious, suggested, or even implied by any of the prior art shell separation devices, either alone or in any combination thereof. To attain this, the present invention generally comprises an opener for separating the shells of a clam or oyster. The inventive device includes a base plate having a support channel for receiving and supporting an oyster. A lever arm is pivotally mounted to the base plate and includes an engaging tip secured to the lever arm and positioned for engagement with the oyster residing within the support channel to effect cracking and opening of the oyster. There has thus been outlined, rather broadly, the more important features of the invention in order that the detailed description thereof that follows may be better understood, and in order that the present contribution to the art may be better appreciated. There are additional features of the invention that will be described hereinafter and which will form the subject matter of the claims appended hereto. In this respect, before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and to the arrangements of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments and of being practiced and carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein are for the purpose of description and should not be regarded as limiting. As such, those skilled in the art will appreciate that the conception, upon which this disclosure is based, may readily be utilized as a basis for the designing of other structures, methods and systems for carrying out the several purposes of the present invention. It is important, therefore, that the claims be regarded as including such equivalent constructions insofar as they do not depart from the spirit and scope of the present invention. Further, the purpose of the foregoing abstract is to enable the U.S. Patent and Trademark Office and the public generally, and especially the scientists, engineers and practitioners in the art who are not familiar with patent or legal terms or phraseology, to determine quickly from a cursory inspection the nature and essence of the technical disclosure of the application. The abstract is neither intended to define the invention of the application, which is measured by the claims, nor is it intended to be limiting as to the scope of the invention in any way. It is therefore an object of the present invention to provide a new clam and oyster opener apparatus and method which has many of the advantages of the shell separation devices mentioned heretofore and many novel features that result in a clam and oyster opener which is not anticipated, rendered obvious, suggested., or even implied by any of the prior art shell separation devices, either alone or in any combination thereof. It is another object of the present invention to provide a new clam and oyster opener which may be easily and efficiently manufactured and marketed. It is a further object of the present invention to provide a new clam and oyster opener which is of a durable and reliable construction. An even further object of the present invention is to provide a new clam and oyster opener which is susceptible of a low cost of manufacture with regard to both materials and labor, and which accordingly is then susceptible of low prices of sale to the consuming public, thereby making such clam and oyster openers economically available to the buying public. Still yet another object of the present invention is to provide a new clam and oyster opener which provides in the apparatuses and methods of the prior art some of the advantages thereof, while simultaneously overcoming some of the disadvantages normally associated therewith. Still another object of the present invention is to provide a new clam and oyster opener for separating the shells of a clam or oyster. Yet another object of the present invention is to provide a new clam and oyster opener which includes a base plate having a support channel for receiving and supporting an oyster, and a lever arm pivotally mounted to the base plate and including an engaging tip secured to the lever arm and positioned for engagement with the oyster residing within the support channel to effect cracking and opening of the oyster. These together with other objects of the invention, along with the various features of novelty which characterize the invention, are pointed out with particularity in the claims annexed to and forming a part of this disclosure. For a better understanding of the invention, its operating advantages and the specific objects attained by its uses, reference should be had to the accompanying drawings and descriptive matter in which there is illustrated preferred embodiments of the invention. BRIEF DESCRIPTION OF THE DRAWINGS The invention will be better understood and objects other than those set forth above will become apparent when consideration is given to the following detailed description thereof. Such description makes reference to the annexed drawings wherein: FIG. 1 is an isometric illustration of a clam and oyster opener according to the present invention. FIG. 2 is a side elevation view thereof. FIG. 3 is a cross-sectional view taken along line 3--3 of FIG. 1. FIG. 4 is an enlarged view of the area set forth in FIG. 2. FIG. 5 is a cross-sectional view taken along line 5--5 of FIG. 4. FIG. 6 is a further cross-sectional view taken along line 6--6 of FIG. 1. FIG. 7 is an enlarged isometric illustration of the area set forth in FIG. 1. DESCRIPTION OF THE PREFERRED EMBODIMENT With reference now to the drawings, and in particular to FIGS. 1-7 thereof, a new clam and oyster opener embodying the principles and concepts of the present invention and generally designated by the reference numeral 10 will be described. More specifically, it will be noted that the clam and oyster opener 10 comprises a base plate 12 positionable upon a support surface and preferably including at least one aperture 14 extending therethrough, as shown in FIG. 7, which permits the passage of a threaded fastener 16 through the base plate 12 to secure the base plate to an underlying support surface. A support channel 18 is secured to a top surface of the base plate 12 and is defined by a first planar member 20 (see FIG. 6) secured to an upper surface of the base plate 12 and oriented at an oblique angle relative thereto, with a second planar member 22 similarly secured to the upper surface of the base plate 12 and oriented at an oblique angle relative to both the base plate and the first planar member 20. The orientation of the first planar member 20 relative to the second planar member 22 defines the substantially V-shape of the support channel 18. By this structure, the clam or oyster can be positioned within the support channel 18 and oriented such that the opening crack of the oyster or clam is positioned within a substantially vertical plane extending through a juncture of the first and second planar members 20, 22. As best illustrated in FIGS. 1 through 3, the clam and oyster opener 10 further comprises a pair of spaced vertical stanchions 24 which extend upwardly from an end of the base plate 12 and cooperate to support an axle 26 therebetween. A pair of brace plates 28 are coupled to vertical edges of the vertical stanchions 24 and to the base plate 12 and cooperate to support the vertical stanchions 24 in a fixed position relative to the base plate. A rotatable tube 30 is concentrically disposed about the axle 26. A lever arm 32 having first and second ends is fixedly secured to the rotatable tube 30 at the first end of the lever arm, and is provided with a handle 34 at the second end thereof, whereby an individual can grasp and manipulate the handle 34 to effect pivotal movement of the lever arm 32 through the vertical plane extending through the support channel 18. Preferably, a length of the rotating tube is substantially less than a distance between the vertical stanchions, as shown in FIG. 1, such that the lever arm can be axially translated laterally as desired to center the lever arm over an oyster or clam. An engaging tip 36 is fixedly secured to the lever arm 32 and is positioned so as to extend into the support channel 18 to engage and open an oyster or clam positioned therewithin as described above. As best illustrated in FIG. 4, it can be shown that the engaging tip 36 comprises a depending projection 38 which is fixedly secured to the lever arm 32 and includes a plurality of spaced transverse slots 40 extending partially therearound. A single longitudinal slot 42 extends into contiguous communication with the spaced transverse slots 40 and permits an adjustable plate 44 to be movably positioned into any one of the spaced transverse slots. As shown in FIG. 5, the adjustable plate 44 is concentrically disposed about the depending projection 38 and includes a radial projection 46 projecting radially inward and into one of the transverse slots 40. By this structure, the adjustable plate 44 can be rotated so as to position the radial projection 46 into the longitudinal slot 42, whereby axial movement of the adjustable plate 44 relative to the depending projection 38 can be accomplished to position the radial projection 46 into another one of the transverse slots 40. Such movement of the adjustable plate 44 allows the same to be positioned at a desired location along the depending projection 38 to limit a distance that the engaging tip 36 extends into the clam or oyster during cracking or opening thereof. The device operates appropriately when the adjustable plate is positioned approximately one and one-half inches from a lower most portion of the engaging tip to preclude damage to the oyster or clam being opened. The engaging tip 36 continues past the adjustable plate 44 into a mounting projection 48 having an annular groove 50 extending circumferentially thereabout. The mounting projection 48 is operable to receive any one of a plurality of tips for mounting thereto. The tips, as shown in FIG. 4, include a blunt tip 52, a sharp tip 54, and a blade tip 56. The tips 52-56 each include a threaded set screw 58 directed therethrough which can be rotatably advanced into engagement with the annular groove 50 to effect securement of the respective tip to the mounting projection 48 of the engaging tip 36. By this structure, a desired tip 52-56 can be selectively coupled to the engaging tip 36 as desired. In use, the clam and oyster opener 10 of the present invention operates to quickly and easily open the shell of the clam or oyster. An individual operating the device 10 can simply place the oyster within the support channel 18 with the lever arm 32 in a raised position, whereby a pivotal motion of the lever arm 32 towards the base plate 12 causes the engaging tip 36 to engage the oyster within the support channel 18 to effect cracking and opening of the oyster. The device 10 is particularly useful in an assembly line operation wherein a first individual hands the clams or oysters to a second individual operating the clam and oyster opener 10 to effect continuous opening of the clam and/or oysters. As to a further discussion of the manner of usage and operation of the present invention, the same should be apparent from the above description. Accordingly, no further discussion relating to the manner of usage and operation will be provided. With respect to the above description then, it is to be realized that the optimum dimensional relationships for the parts of the invention, to include variations in size, materials, shape, form, function and manner of operation, assembly and use, are deemed readily apparent and obvious to one skilled in the art, and all equivalent relationships to those illustrated in the drawings and described in the specification are intended to be encompassed by the present invention. Therefore, the foregoing is considered as illustrative only of the principles of the invention. Further, since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation shown and described, and accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the invention.

1a

This is a Utility Patent Application for Provisionally File Application No. 60/252,693 filed on Nov. 24, 2000. BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates generally to a barbecue grill and more particularly to an adjustable barbecue grill apparatus that includes a grill surface that is adapted to easily and quickly expand or decrease in length for innately providing an increased or decreased cooking surface and/or increase or decrease in height, consequently providing a customized and comfortable fit for the particular cook. Inherently providing a grill that will enable a cook to efficiently and successfully accommodate any amount of food by rendering a cook to utilizes the desired amount of grill space for optimizing the cooking process for the comestibles on the grill surface. 2. Description of the Prior Art It is undeniable that food cooked on a grill is not only deliciously but also provides a healthy means of preparing comestibles. Many find that grilling produces tasty cuisine, at the same time providing the act of grilling to be an easy and enjoyable task. Thus, it is not surprising that most homes today do have one form or another of a grill. Grills come in a variety of shapes, sizes, forms and even being configured for a specialized task, such as smoking. To aid and assist the cook, devices have been developed for improving on a variety of grilling apparatus. For example in U.S. Pat. No. 5,481,964 issued to Kitten there is disclose a barbecue pit that is designed and configured to improve the process of barbecuing by providing a barbecue pit that will providing even heat distribution in the even by providing an oven that is rarely opened. Thereby preventing the smoke and heat to escape therefrom. To enable such a configuration, this grilling apparatus comprises an oven and a firebox mounted upon a frame. Access to the oven is provided for by a rack opening wherein a rack rolls in and out of the oven on rollers and features a series of doors which close the rack opening of the oven when the doors are properly aligned. For food which require different heat for successful cooking a grill is disclosed in U.S. Pat. No. 4,932,390 issued to Ceravolo wherein there is disclosed is a food support grid that is adjustable both vertically and rotatively so as to provide for the food to be position at a certain location above the heat source. Yet another example of a device which does not drastically disrupt the cooking temperature when inspecting the cooked food is seen in U.S. Pat. No. 4,840,118 issued to Rinehart. In this patent there is disclosed a grill having a grate or tray which is sidably mounted on tracks. This grate or tray is pulled horizontally outwardly from the interior of the housing for rendering an inspection of food in a smoke-free environment. To address the concerns of flames that can develop as drops of fat fall into the heating chamber of a grill, in U.S. Pat. No. 4,628,896 issued to Baynes discloses a barbecue grill featuring a moveable grid. This grid can be shifted horizontally to move the meat away from the heating chamber, and once the flames subside can be replace thereon at the desired position. Accordingly, it is seen that there exist a numerous styles of grills, each address a specialized concern or problem generally associated with grilling. What is not disclosed is a grill that includes a means of adjusting, either by increasing and/or decreasing the particular cooking surface. In addition, the prior is silent to a means of adjusting the height of the actual grill for consequently providing a grill that can easily be transportable as well as convenient to the user. As can be seen, what is needed is a grill apparatus that will successfully and efficiently accommodate any amount of food without adversely affecting the time, space, energy and fuel used with the cooking particular of the particular amount of food. As will be seen, the present invention achieves its intended purposes, objectives and advantages by accomplishing the needs as identified above, through a new, useful and unobvious combination of component elements, which is simple to use, with the utilization of a minimum number of functioning parts, at a reasonable cost to manufacture, assemble, test and by employing only readily available material. SUMMARY OF THE INVENTION The present invention is a unique multifunctional portable barbecue grill that is designed and configured to expand in order to increase the total size the cooking surface of the particular grill. In addition, for convenience and added comfort, the mainframe of the grill can be altered in sized to provide for a comfortable height for the cook as well as provide for an easy means for storage and transportability. In order to provide for such a configuration, the present invention comprises a support frame that maintains housing. The support frame and housing each include an inner member and an outer member. The inner member being slideably mounted within the outer member. As such, the outer member of the support frame includes a horizontal support arm and a pair of vertical legs attached to a side thereof. The outer support arm includes an opening, which forms a sleeve for receiving and maintaining a support arm of the inner frame. A second pair of vertical legs is attached to the opposite side of the inner frame. In use the inner arm will slide into the sleeve of the outer arm and the legs of the inner and outer supports will maintain the grill body of the present invention. For ease of adjustment and for ease in transportability, each leg can include lockable wheels. The inner member of the housing is attached to the inner arm. Thus, as the arm is slid outward, the inner member of the housing will inherently slide outward. The inner member and outer member of the housing each include a lower section and an upper section. The lower section maintains the heating element, such as lava rocks for gas grills or coals for charcoal grills. The lower section of the inner member includes an access means for allowing access to the interior for permitting maintenance to occur as necessary. Hindgedly secured to lower section is the upper section. This upper section acts as the lid and as such each includes a handle for lifting the lid and apertures for ventilation. A thermostat or the like can also be located on each lid for displaying the temperature within the housing. A shelf or the like can be exteriorly attached to the housing of the inner frame member, outer frame member or a combination thereof. To enable the slideable connection of the housing, the inner member is substantially the same shaped, but smaller in size to allow for inner member to slide freely into the outer member. A locking device can be attached to provide for the inner member to be in a locked and secured position once the desired length is met. Removably secured the lower section of the inner and outer housings is a grate. The outer grate member includes a plurality of parallel disposed hollow sleeves. Slideably located within each sleeve is a rod. As the inner frame is pulled outward, the housing is inherently adjusted horizontally, causing the rods to be removed from the hollow sleeves. Once at the desired located, the housing and/or frame are locked into position, and the sleeves and rods form the cooking surface. Thus providing for the sleeves and rods to form the grate. For enhancing the present invention, the legs on the inner and outer frame member can be adapted to be adjustable vertically. To provide for such an adjustment, conventional adjusting means can be utilized. Thereby, providing a grill that can be used by any individual, regardless of size and height, as well as provide for a grill that can easily be transported and stored. Accordingly, it is the object of the present invention to provide a multifunctional portable barbecue grill that includes expandable capabilities so as to provide for a grill apparatus that will overcome the deficiencies, shortcomings, and drawbacks of the prior art and methods thereof. Accordingly, it is the object of the present invention is to provide a novel and unique multifunctional portable barbecue grill which is adapted to easily and efficiently adjusted in length so as to innately increase the cooking surface of the portable grill. Another object of the present invention is to provide a multifunctional portable barbecue grill apparatus that is easy to operate, successful in grilling regardless of its size and one that will safely allow for alternating size differences. Yet another object of the present invention is to provide a multifunctional portable barbecue grill apparatus that is lightweight, adjustable in height, and one that is completely portable. A final object of the present invention, to be specifically enumerated herein, is to provide a portable expansion barbecue grill in accordance with the preceding objects and which will conform to conventional forms of manufacture, be of simple construction and easy to use so as to provide a device that would be economically feasible, long lasting and relatively trouble free in operation. Although there have been other barbecue grills, none of these inventions utilize a means of extending the cooking area of the grill as disclosed with the present invention. In addition the present invention will prove to be sufficiently compact, low cost, and reliable enough to become commonly used. The present invention meets the requirements of the simplified design, compact size, low initial cost, low operating cost, ease of installation and maintainability, and minimal amount of training to successfully employ the invention. The foregoing has outlined some of the more pertinent objects of the invention. These objects should be construed to be merely illustrative of some of the more prominent features and application of the intended invention. Many other beneficial results can be obtained by applying the disclosed invention in a different manner or modifying the invention within the scope of the disclosure. Accordingly, a fuller understanding of the invention may be had by referring to the detailed description of the preferred embodiments in addition to the scope of the invention defined by the claims taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWING FIG. 1 is an exploded perspective view of the multifunctional portable barbecue grill apparatus of the present invention, in an expanded position. FIG. 2 is a side view of the multifunctional portable barbecue grill apparatus of the present invention. FIG. 3 is a perspective front view of the multifunctional portable barbecue grill apparatus of the present invention in an extended position. FIG. 4 is a top perspective view of the multifunctional portable barbecue grill apparatus of the present invention in an extended position. Similar reference numerals refer to similar parts throughout the several views of the drawings. DESCRIPTION OF THE PREFERRED EMBODIMENT With reference to the drawings, in particular to FIGS. 1-4 thereof, the present invention, denoted by reference number 10 , known as a portable expandable barbecue grill will be described. As seen in the figures, the present invention is a grill apparatus 10 designed and configured to adjust in length so as to provide for an increase or decrease in cooking surface. In addition, the present invention can be altered in height so as to accommodate any size person, or alternatively, to provide for a device that can easily be towed via vehicle or stored at any location. To provide for such a configuration, the present invention comprises a present invention comprises a support frame 12 that maintains a housing 14 . The support frame and housing each include an inner member 16 a , 18 a , respectively, and an outer member 16 b , 18 b respectively. The inner member 16 a of the frame being slideably mounted within the outer member 16 b of the frame. The inner member of the housing 18 a being slideably mounted within the outer member of the housing 18 b. As such, the outer member 16 b of the support frame 12 includes a horizontal support arm 20 . This support arm 20 includes an outer end and an inner end. Secured to the outer ends is a pair of vertical legs 22 a . Slideably mounted to the inner end of the support arm 20 is the inner frame member 16 a . To receive the inner frame member 16 a , the support arm 20 includes a groove 24 that forms a sleeve. The outer support arm 20 includes an opening, which forms a sleeve for receiving and maintaining a support arm of the inner frame. This outer support arm 20 is secured exteriorly to the outer housing 18 b. An inner support arm 26 includes an outer end and an inner end. The inner end is received within the groove 24 and as such provides for the inner support arm 26 to be slideably mounted within the groove 24 . Located at the outer end of the inner support arm 26 is an attaching member 28 . This member receives the outer end of the inner housing 18 a so as to provide for the outer end of the inner housing to be secured to the inner support arm 26 via the attaching member 28 . Also secured to this attaching member 28 is a second set of vertical legs 22 b . Though not illustrated, a handle can be attached to this attaching member for enabling the user to grab the handle and pull or push the inner support arm 26 out or in the groove of the outer support arm 20 . Accordingly, as the user pulls out the attaching member, the inner support bar slides out of the groove. Since the attaching member is attached to the inner housing, the inner housing is inherently slid out or m as well. Thus rendering an extended or non-extended grill. A locking device, as illustrated but not labeled, can be located on the frame. This locking device is conventional and will ensure that the inner frame member will be secured to the outer frame member when in a desired position. As seen in the various drawings, FIGS. 1-4, the inner member 18 a and outer member 18 b of the housing 14 each include a lower section 30 and 32 , respectively and an upper section 34 and 36 , respectively. The lower section 30 and 32 maintains the heating element, such as lava rocks for gas grills or coals for charcoal grills. The lower section will be designed so as to accommodate the preferred heating system. The lower section 30 of the inner member 18 a , and/or the lower section 32 of the outer member 18 b include an access means 38 for allowing access to the interior for permitting maintenance to occur as necessary. Hindgedly secured to lower section 30 and 32 is the upper section 34 and 36 . This upper section 34 and 36 act as the lid and as such each includes a handle 40 for lifting the lid and apertures 42 for ventilation. This aperture can include a pivotally or hingedly located cover for enabling the user to decide the need and the amount for ventilation. It is noted that the handle located on the inner housing is sized such that the housing can slid freely within the outer housing and be non-obtrusive. A thermostat 44 or the like can also be located on each lid for displaying the temperature within the housing. A shelf 46 or the like can be exteriorly attached to the housing 14 of the inner housing, outer housing or a combination thereof. To enable the slideable connection of the housing 14 , the inner member 18 a is substantially the same shape, but smaller in size to allow for inner member 18 a to slide freely into the outer member 18 b . A locking device 48 can be attached to provide for the inner member to be in a locked and secured position once the desired length is met. This locking member 48 can be any conventional locking device. This locking device can be located on the lid, on any surface of the housing or a combination thereof This will provide for a locking device that can be located at any location that will enable adequate locking capabilities. Removably secured the lower section 30 and 32 , respectively, of the inner and outer housings 18 a and 18 b , respectively is a grate 50 . The grate comprises an inner grate member 52 a and an outer grate member 52 b , wherein the inner grate is slideably secured to the outer grate member. As seen in the drawings the outer grate 52 b is secured to the lower section of the outer housing via conventional means such as by hooks, groove or the like. This grate 52 b includes a plurality of parallel disposed hollow sleeves 54 . Perpendicular crossbars 56 can be secured to the hollow sleeves for additional support. Slideably located within each sleeve 54 is a rod 58 . Each rod includes an inner end and an outer end. The inner is received within the sleeve. The outer end is secured to a perpendicularly disposed cross bar 60 . This cross bar 60 is removably secured to the inner housing via conventional means, such as by hooks or the like. Optionally, the front most and back most rod can be secured to the side of the housing. This will ensure the securement of the grate. Accordingly, as the inner frame is pulled outward, the housing is inherently adjusted horizontally, causing the rods to be removed from the hollow sleeves. Once at the desired length is located, the housing and/or frame are locked into position, and the sleeves and rods form the cooking surface. Thus providing for the sleeves and rods to form the grate. A handle can be secured to the inner and outer portions of the grate. This handle is illustrated but not labeled. As seen in the drawings, the handle is secured to the outer grate and is slideable mounted to the inner grate. To provide for a slideably connection, conventional means is utilized. In this embodiment, as shown, the handle on the inner grate includes an aperture. This aperture receives a rod of the inner grate. The rod slides within this aperture and thus enables the handle to accommodate any length grate. Two handles can be located thereon to provide for a handle to be located near the front of the grill and a second handle to be located in the rear of the grill. This arrangement will ensure adequate removal of the grate. For enhancing the present invention, the legs can include lockable wheels, illustrated, but not labeled. The wheels can be enlarged to provide for the grilled to be transported across a variety of terrain, easily and effortlessly. In addition the legs can be adjusted and/or removably from the support bars. This provides for a grill that can be utilized by any cook, regardless of their size or stored for easy transportation. The legs can be adjusted via any conventional means, but preferably, and as illustrated, the legs can be adjusted via the system as shown in the figures. As seen, the support 20 and attaching member 28 include a receiving member 62 for each leg. The receiving member will lock the upper end of the leg via the use of a butter fly nut 64 . The upper portion of each leg 66 is secured to the receiving member 62 . This upper portion 66 is designed and configured to slideably receive the lower portion of the leg 68 . In order to achieve the desired height, the lower portion of the leg 68 is slid within the upper portion 66 . Once the desired height is achieved, the lower portion is locked into place via a butterfly pin or the like, as shown. While the invention has been particularly shown and described with reference to an embodiment thereof, it will be understood by those skilled in the art that various changes in form and detail may be made without departing from the spirit and scope of the invention.

1a

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit of the filing date of U.S. Provisional Patent Application No. 60/546,027 filed Feb. 19, 2004, the disclosure of which is hereby incorporated herein by reference. FIELD OF THE INVENTION [0002] This invention relates generally to a spinal implant assembly for implantation into the intervertebral space between adjacent vertebral bones to simultaneously provide stabilization and continued flexibility and proper anatomical motion, and more specifically to such a device that has limited rotation using an uncaptured ball and socket joint with a partial ball having a large radius and substantially continuous radii of curvature. BACKGROUND OF THE INVENTION [0003] The bones and connective tissue of an adult human spinal column consists of more than twenty discrete bones coupled sequentially to one another by a tri-joint complex that consists of an anterior disc and the two posterior facet joints, the anterior discs of adjacent bones being cushioned by cartilage spacers referred to as intervertebral discs. These more than twenty bones are anatomically categorized as being members of one of four classifications: cervical, thoracic, lumbar, or sacral. The cervical portion of the spine, which comprises the top of the spine, up to the base of the skull, includes the first seven vertebrae. The intermediate twelve bones are the thoracic vertebrae, and connect to the lower spine comprising the five lumbar vertebrae. The base of the spine is the sacral bones (including the coccyx). The component bones of the cervical spine are generally smaller than those of the thoracic spine, which are in turn smaller than those of the lumbar region. The sacral region connects laterally to the pelvis. While the sacral region is an integral part of the spine, for the purposes of fusion surgeries and for this disclosure, the word spine shall refer only to the cervical, thoracic, and lumbar regions. [0004] The spinal column is highly complex in that it includes these more than twenty bones coupled to one another, housing and protecting critical elements of the nervous system having innumerable peripheral nerves and circulatory bodies in close proximity. In spite of these complications, the spine is a highly flexible structure, capable of a high degree of curvature and twist in nearly every direction. [0005] Genetic or developmental irregularities, trauma, chronic stress, tumors, and degenerative wear are a few of the causes that can result in spinal pathologies for which surgical intervention may be necessary. A variety of systems have been disclosed in the art that achieve immobilization and/or fusion of adjacent bones by implanting artificial assemblies in or on the spinal column. The region of the back that needs to be immobilized, as well as the individual variations in anatomy, determine the appropriate surgical protocol and implantation assembly. With respect to the failure of the intervertebral disc, the interbody fusion cage has generated substantial interest because it can be implanted laparoscopically into the anterior of the spine, thus reducing operating room time, patient recovery time, and scarification. [0006] Referring now to FIGS. 1-2 , in which a side perspective view of an intervertebral body cage and an anterior perspective view of a post implantation spinal column are shown, respectively, a more complete description of these devices of the prior art is herein provided. These cages 1 generally comprise tubular metal body 2 having an external surface threading 3 . They are inserted transverse to the axis of the spine 4 , into preformed cylindrical holes at the junction of adjacent vertebral bodies (in FIG. 14 the pair of cages 1 are inserted between the fifth lumbar vertebra (L5) and the top of the sacrum (S1)). Two cages 1 are generally inserted side by side with the external threading 4 tapping into the lower surface of the vertebral bone above (L5), and the first surface of the vertebral bone (S1) below. The cages 1 include holes 5 through which the adjacent bones are to grow. Additional materials, for example autogenous bone graft materials, may be inserted into the hollow interior 6 of the cage 1 to incite or accelerate the growth of the bone into the cage. End caps (not shown) are often utilized to hold the bone graft material within the cage 1 . [0007] These cages of the prior art have enjoyed medical success in promoting fusion and grossly approximating proper disc height. It is, however, important to note that the fusion of the adjacent bones is an incomplete solution to the underlying pathology as it does not cure the ailment, but rather simply masks the pathology under a stabilizing bridge of bone. This bone fusion limits the overall flexibility of the spinal column and artificially constrains the normal motion of the patient. This constraint can cause collateral injury to the patient's spine as additional stresses of motion, normally borne by the now-fused joint, are transferred onto the nearby facet joints and intervertebral discs. It would therefore, be a considerable advance in the art to provide an implant assembly which does not promote fusion, but, rather, which mimics the biomechanical action of the natural disc cartilage, thereby permitting continued normal motion and stress distribution. [0008] It is, therefore, an object of the invention to provide an intervertebral spacer that stabilizes the spine without promoting a bone fusion across the intervertebral space. [0009] It is further an object of the invention to provide an implant device that stabilizes the spine while still permitting normal motion. [0010] It is further an object of the invention to provide a device for implantation into the intervertebral space that does not promote the abnormal distribution of biomechanical stresses on the patient's spine. [0011] It is further an object of the invention to provide an artificial disc that provides free rotation of the baseplates relative to one another. [0012] It is further an object of the invention to provide an artificial disc that supports compression loads. [0013] It is further an object of the invention to provide an artificial disc that permits the baseplates to axially compress toward one another under a compressive load. [0014] It is further an object of the invention to provide an artificial disc that permits the baseplates to axially compress toward one another under a compressive load and restore to their original uncompressed relative positions when the compressive load is relieved. [0015] It is further an object of the invention to provide an artificial disc that prevents lateral translation of the baseplates relative to one another. [0016] It is further an object of the invention to provide an artificial disc that provides a centroid of motion centrally located within the intervertebral space. [0017] It is further an object of the invention to provide artificial intervertebral disc baseplates having outwardly facing surfaces that conform to the concave surface of adjacent vertebral bodies. [0018] It is a further object of the present invention to provide a disc replacement device having a first element for seating against a lower endplate surface of a superior vertebral body and a second element for seating against an first end plate surface of an inferior vertebral body, said baseplates having disposed therebetween a partial spherical member having a large radius disposed in a complementary concavity such that said baseplates are articulatable against one another. [0019] It is yet a further object of the present invention to provide a disc replacement device that is resistant to point loading and fatigue failure. [0020] It is still a further object of the present invention to provide a disc replacement device employing ball and socket type articulation using a partial spherical member wherein said partial spherical member is not captured. [0021] Other objects of the invention not explicitly stated will be set forth and will be more clearly understood in conjunction with the descriptions of the preferred embodiments disclosed hereafter. SUMMARY OF THE INVENTION [0022] The preceding objects are achieved by the invention, which is an artificial intervertebral disc or intervertebral spacer device comprising a pair of support members (e.g., spaced apart baseplates), each with an outwardly facing surface. Because the artificial disc is to be positioned between the facing endplates of adjacent vertebral bodies, the baseplates are arranged in a substantially parallel planar alignment (or slightly offset relative to one another in accordance with proper lordotic angulation) with the outwardly facing surfaces facing away from one another. The baseplates are to mate with the vertebral bodies so as to not rotate relative thereto, but rather to permit the spinal segments to bend (and in some embodiments, axially compress) relative to one another in manners that mimic the natural motion of the spinal segment. This natural motion is permitted by the performance of a ball and socket type joint using a partial spherical member disposed between the secured baseplates, and the securing of the baseplates to the vertebral bone is achieved through the use of a vertebral body contact element attached to the outwardly facing surface of each baseplate. [0023] Preferable vertebral body contact elements include, but are not limited to, one or more of the following: a convex mesh, a convex solid dome, and one or more spikes. The convex mesh is preferably secured at its perimeter to the outwardly facing surface of the respective baseplate. This can be accomplished in any effective manner, however, laser welding and plasma coating burying are two preferred methods when the mesh is comprised of metal. While domed in its initial undeflected conformation, the mesh deflects as necessary during insertion of the artificial disc between vertebral bodies, and, once the artificial disc is seated between the vertebral bodies, the mesh deforms as necessary under anatomical loads to reshape itself to the concave surface of the vertebral endplate. Thus, the mesh is deformably reshapeable under anatomical loads such that it conformably deflects against the concave surface to securably engage the vertebral body endplate. Stated alternatively, because the mesh is convexly shaped and is secured at its perimeter to the baseplate, the mesh is biased away from the baseplate but moveable toward the plate (under a load overcoming the bias; such a load is present, for example, as an anatomical load in the intervertebral space) so that it will securably engage the vertebral body endplate when disposed in the intervertebral space. This affords the baseplate having the mesh substantially superior gripping and holding strength upon initial implantation, as compared with other artificial disc products. The convex mesh further provides an osteoconductive surface through which the bone may ultimately grow. The mesh preferably is comprised of titanium, but can also be formed from other metals and/or non-metals. Inasmuch as the mesh is domed, it does not restrict the angle at which the artificial disc can be implanted. It should be understood that while the flexible dome is described herein preferably as a wire mesh, other meshed or solid flexible elements can also be used, including flexible elements comprised of non-metals and/or other metals. Further, the flexibility, deflectability and/or deformability need not be provided by a flexible material, but can additionally or alternatively be provided mechanically or by other means. [0024] It should be understood that the convex mesh attachment devices and methods described herein can be used not only with the artificial discs and artificial disc baseplates described or referred to herein, but also with other artificial discs and artificial disc baseplates, including, but not limited to, those currently known in the art. Therefore, the description of the mesh attachment devices and methods being used with the artificial discs and artificial disc baseplates described or referred to herein should not be construed as limiting the application and/or usefulness of the mesh attachment device. [0025] To enhance the securing of the baseplates to the vertebral bones, each baseplate further comprises a porous area, which at least extends in a ring around the lateral rim of each outwardly facing surface. The porous area may be, for example, a sprayed deposition layer, or an adhesive applied beaded metal layer, or another suitable porous coating known in the art. The porous ring permits the long-term ingrowth of vertebral bone into the baseplate, thus permanently securing the prosthesis within the intervertebral space. The porous layer may extend beneath the domed mesh as well, but is more importantly applied to the lateral rim of the outwardly facing surface of the baseplate that seats directly against the vertebral body. [0026] Some of the embodiments described herein use two baseplates each having the above described convex mesh on its outwardly facing surface, while other embodiments use two baseplates each having a convex solid dome in combination with a plurality of spikes on the lateral rim of the outwardly facing surface of the baseplates. It should be understood, however, that the various attachments devices or methods described herein (as well as any other attachment devices or methods, such as, for example, keels) can be used individually or in combination in any permutation, without departing from the scope of the present invention. [0027] The ball and socket joint, employing a partial spherical member that is not captured, disposed between the baseplates permits rotation and angulation of the two baseplates relative to one another about a centroid of motion centrally located between the baseplates. A variety of embodiments are contemplated. In some embodiments, the joint is used in conjunction with a resilient member to additionally permit the two baseplates to axially compress relative to one another. Further in each of the embodiments, the assembly prevents lateral translation of the baseplates during rotation and angulation. [0028] It should be understood that the described embodiments and embodiment families are merely examples that illustrate aspects and features of the present invention, and that other embodiments and embodiment families are possible without departing from the scope of the invention. [0029] Each of the embodiments discussed herein share the same basic elements, some of which retain identical functionality and configuration across the embodiments, and some of which gain or lose functionality and/or configuration across the embodiments to accommodate mechanical and/or manufacturing necessities. More specifically, each of the embodiments includes two baseplates, each having an inwardly directed articulation surface, having a ball and socket joint disposed therebetween employing an uncaptured partial spherical member that is established centrally between the baseplates. The partial spherical member has a large radius and substantially continuous arc of curvature to minimize point loading and reduce the risk and incidence of fatigue failure. Each of the embodiments will be understood further in light of the additional descriptions of the embodiments herein. [0030] The inwardly directed articulation surface of the first baseplate is adapted such that extending thereform is a member having at its distal end a partial spherical member. The partial spherical member is defined by a convex arc that forms the articulation surface that is complementary to a concave articulation surface of the second baseplate. [0031] In a preferred embodiment the longitudinally inwardly directed articulation surface of the first baseplate comprises essentially a centrally disposed projection having a central bore for receiving and/or retaining an elongated member. The projection is sized to have a diameter less than the diameter of the inwardly directed concave articulating surface of the second baseplate. The projection preferably has a cross section that is cylindrical or frustoconical. [0032] In a preferred embodiment, the elongated member comprises essentially a mushroom-shaped pin having an elongated portion and a head portion, the elongated portion thereof seated in a central bore of the first baseplate and the head portion, located distally, having a convex arc having a substantially constant radius of curvature A. The pin shaped member may be fixedly engaged in the bore or may be slidably engaged in the bore. In the embodiment in which the pin is slidably engaged in the bore, in a preferred embodiment a resilient annular member such as a resilient washer or the like is optionally deployed over the projection of the first baseplate as a shock absorber, the resilient annular member being positioned with one side facing the surface adjacent the projection of the first member and the opposite side of the annular resilient member facing the interior of the head of the pin-shaped member. [0033] The elongated portion of the pin member preferably comprises a continuous cylindrical cross section; however, the cross section may vary toward the distal end thereof, such as by gradually or abruptly thickening near the juncture of the elongated member and the head portion, to provide structural strength. [0034] The longitudinally inwardly directed articulation surface of the second baseplate is a substantially constant radii concave articulation surface forming a curvate socket. [0035] The constant radii articulation surfaces are configured and sized to be nestable against one another and articulatable against one another, to enable adjacent vertebral bones (against which the first and second baseplates are respectively disposed in the intervertebral space) to articulate in flexion, extension, and lateral bending. More particularly, the artificial disc implant of the present invention is assembled by disposing the first and second baseplates such that the vertebral body contact surfaces are directed away from one another, and the articulation surfaces are nested against one another such that the concave arc accommodates the convex arc. [0036] The curvate socket defines a spherical contour that closely accommodates the partial spherical member for free rotation and angulation. Therefore, when seated in the curvate socket, the partial spherical member can rotate and angulate freely relative to the curvate socket through a range of angles, thus permitting the opposing baseplates to rotate and angulate freely relative to one another through a corresponding range of angles equivalent to the fraction of normal human spine rotation and angulation (to mimic normal disc rotation and angulation). Because the baseplates are made angulatable relative to one another by the partial spherical member being rotatably and angulatably coupled in the curvate socket, the disc assembly provides a centroid of motion within the sphere defined by the partial spherical member. Accordingly, the centroid of motion of the disc assembly remains centrally located between the vertebral bodies, similar to the centroid of motion in a healthy natural intervertebral disc. [0037] Optionally, the end of the mushroom-shaped pin element proximal to the baseplate, and the bore in which it is located, may be covered by a vertebral body contact element disposed on or as the outside surface of the baseplate. In such an embodiment it is preferable to include such a vertebral body contact element disposed on or as the opposing baseplate for purposes of symmetry. Such contact elements are preferably contoured to match the contour of the surface it contacts in the intervertebral space. [0038] In other preferred embodiments of the present invention, an intervertebral device includes a first plate having an outer face and an inner face, and a second plate juxtaposed with the first plate, the second plate having an outer face, an inner face that opposes the first plate and a concavity that opposes the first plate. The device preferably includes an elongated member extending from the first plate toward the second plate, the elongated member having a distal end with a spherical surface that is engageable with the concavity of the second plate for providing an articulating joint between the first and second plates. The device also desirably includes a resilient member in contact with the elongated member for counteracting compressive loads on the plates, whereby the resilient member is surrounded by the concavity of the second plate. [0039] In other preferred embodiments of the present invention, an intervertebral device includes a first plate having an outer face and an inner face, a second plate juxtaposed with the first plate, the second plate having an outer face and an inner face that opposes the first plate, and a ball and socket articulating joint provided between the first and second plates. The device also preferably includes a resilient member in contact with the ball portion of the ball and socket articulating joint for counteracting compressive loads on the plates, whereby the resilient member extends between the first and second plates and is surrounded by the socket portion of the articulating joint. [0040] In still other preferred embodiments of the present invention, an intervertebral device includes a first plate having an outer face and an inner face, a second plate juxtaposed with the first plate, the second plate having an outer face and an inner face that opposes the first plate, the inner face of the second plate having a concavity, and an elongated member extending from the inner face of the first plate toward the second plate, the elongated member being slideably attached to the first plate and having a distal end with a spherical surface that forms a ball and socket-like articulating joint between the first and second plates. The device may also include a resilient member in contact with the distal end of the elongated member for counteracting compressive loads on the plates. The concavity of the second plate desirably surrounds the resilient member. The elongated member may have a mushroom-shaped head at the distal end thereof. [0041] These and other preferred embodiments of the present invention will be described in more detail below. BRIEF DESCRIPTION OF THE DRAWINGS [0042] FIG. 1 shows a side perspective view of a prior art interbody fusion device. [0043] FIG. 2 shows a front view of the anterior portion of the lumbo-sacral region of a human spine, into which a pair of interbody fusion devices of FIG. 1 have been implanted. [0044] FIG. 3 is a cross sectional view of a first embodiment of the present invention, the first baseplate having an inwardly directed articulating surface having extending therefrom a mushroom-shaped pin element having a partial spherical element at the distal end thereof and a second baseplate having a circular recess within which seats the convex structure of the partial spherical element of the first baseplate. [0045] FIG. 4 is a cross-sectional view of a second embodiment of the present invention in which the pin element is slidably engaged in a central bore of the first baseplate and further includes a resilient member disposed between the first and second baseplates. [0046] FIG. 5 is a cross-sectional view of a preferred embodiment of the present invention. [0047] FIG. 6 is a cross-sectional view of a preferred embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0048] While the invention will be described more fully hereinafter with reference to the accompanying drawings, in which particular embodiments and methods of implantation are shown, it is to be understood at the outset that persons skilled in the art may modify the invention herein described while achieving the functions and results of the invention. Accordingly, the descriptions that follow are to be understood as illustrative and exemplary of specific structures, aspects and features within the broad scope of the invention and not as limiting of such broad scope. Like numbers refer to similar features of like elements throughout. [0049] A preferred embodiment of the present invention will now be described. [0050] Referring to FIG. 3 , the invention is shown having a first baseplate 10 and a second baseplate 30 and a pin 50 . Each baseplate 10 , 30 has an outwardly facing surface 12 , 32 . Because the artificial disc of the invention is to be positioned between the facing surfaces of adjacent vertebral bodies, the two baseplates 10 , 30 used in the artificial disc are disposed such that the outwardly facing surfaces 12 , 32 face away from one another. The two baseplates 10 , 30 are to mate with the vertebral bodies so as to not rotate relative thereto, but rather to permit the spinal segments to bend relative to one another in manners that mimic the natural motion of the spinal segment. This motion is permitted by the performance of a ball and socket joint disposed between the secured baseplates 10 , 30 . The mating of the baseplates 10 , 30 to the vertebral bodies and the construction of the ball and socket joint are described below. [0051] More particularly, each baseplate 10 , 30 is a plate (preferably made of a metal or metal alloy, such as, for example, cobalt-chromium or titanium) having an overall shape that conforms to the overall shape of the respective endplate of the vertebral body with which it is to mate. Further, each baseplate 10 , 30 comprises a vertebral body contact element 80 , 82 (e.g., a convex mesh, preferably oval in shape) that is attached to the outwardly facing surface 12 , 32 of the baseplate 10 , 30 to provide a vertebral body contact surface. The mesh 80 , 82 is secured at its perimeter to the outwardly facing surface 12 , 32 of the baseplate 10 , 30 . The mesh 80 , 82 is domed in its initial undeflected conformation, but deflects as necessary during insertion of the artificial disc between vertebral bodies, and, once the artificial disc is seated between the vertebral bodies, deforms as necessary under anatomical loads to reshape itself to the concave surface of the vertebral endplate. This affords the baseplate 10 , 30 having the mesh 80 , 82 substantially superior gripping and holding strength upon initial implantation as compared with other artificial disc products. The mesh 80 , 82 further provides an osteoconductive surface through which the bone may ultimately grow. The mesh 80 , 82 is preferably comprised of titanium, but can also be formed from other metals and/or non-metals without departing from the scope of the invention. [0052] Each baseplate 10 , 30 may further comprises at least a lateral ring (not shown) that is osteoconductive, which may be, for example, a sprayed deposition layer, or an adhesive applied beaded metal layer, or another suitable porous coating. This porous ring permits the long-term ingrowth of vertebral bone into the baseplate 10 , 30 , thus permanently securing the prosthesis within the intervertebral space. It shall be understood that this porous layer may extend beneath the domed mesh 80 , 82 as well, but is more importantly applied to the lateral rim of the outwardly facing surface 12 , 32 of the baseplate 10 , 30 that seats directly against the vertebral body. [0053] Each of the baseplates 10 , 30 comprises features that, in conjunction with other components described below, form the ball and socket joint. The first baseplate 10 includes an inwardly facing articulating surface 18 that includes a perimeter region 20 and a projection 22 protruding from the inwardly facing surface 18 . The projection 22 preferably has a cylindrical or frustoconical cross section. The projection 22 further includes an axial bore 26 that accepts a mushroom-shaped pin 50 (or rivet, plug, dowel, or screw). [0054] The second baseplate 30 comprises an inwardly facing articulation surface 34 having a peripheral surface 36 and a curvate socket 38 , the socket 38 having a substantially constant radii concave articulation surface. [0055] Pin 50 further comprises an elongated portion 52 and a head 54 , the head 54 having a convex arc having a substantially constant radius of curvature. The arc of head 54 is such that the sphere it defines has a large radius, thereby minimizing point loading and the risk of fatigue failure. [0056] The projection 22 of baseplate 10 is sized to have a diameter at least a portion of which is less than the diameter of the socket 38 . The projection 22 preferably has a cross section that is cylindrical or frustoconical. [0057] In a first embodiment, the elongated portion 52 of mushroom-shaped pin 50 is disposed in bore 26 of the baseplate 10 and the head 54 is nested in socket 38 . Pin 50 is fixedly engaged by force fitting, welding or the like in bore 26 . Head 54 is not captured in socket 38 . Baseplates 10 and 30 are at no time connected to each other in the ball and socket joint of the present invention. [0058] Optionally, the end of pin 50 proximal to the baseplate 10 , and the bore 26 , are covered by a vertebral body contact element 80 disposed over the outside surface 12 of the baseplate 10 . In such an embodiment it is preferable to include a vertebral body contact element 82 on the baseplate 30 for purposes of symmetry. Such contact elements 80 and 82 are preferably contoured to match the contour of the surface it contacts in the intervertebral space. [0059] Now referring to FIG. 4 , in a preferred embodiment, pin 50 is slidably engaged in bore 26 . In this embodiment, in a preferred embodiment a resilient annular member 60 such as a resilient washer or the like is deployed over the projection 22 (which in this embodiment is preferably cylindrical) of the first baseplate 10 as a shock absorber, the resilient annular member 60 being sized and positioned such that it functions as a force restoring element (e.g., a spring) that provides axial cushioning to the device, by deflecting under a compressive load and restoring when the load is relieved. [0060] Now referring to FIGS. 5 and 6 , in other embodiments the elongated portion 52 of pin 50 preferably has a continuous cylindrical cross section; however, the cross section may vary toward the distal end thereof, such as by gradually or abruptly thickening near the juncture of the elongated member 52 and the head 54 , to provide structural strength and/or to provide a different location for resilient member 60 . Now referring to FIG. 5 , in a preferred embodiment resilient member 60 is a continuous collar comprising a spring having a cylindrical cross section. It is desirable, but not essential, to use a spring as the resilient member 60 because of the ability of a spring to hold its diameter when subjected to compressive force. In a most preferred embodiment resilient member 60 is retained in a retainer 62 . Retainer 62 is formed of a resilient material such as but not limited to an elastomeric material. In this embodiment elongated member 52 has a frustoconical section 56 adjacent proximal head 54 such that resilient member 60 and retainer 62 are firmly engageable in a seat formed between the frustoconical section 56 of elongated portion 52 and the end 28 of projection 22 . As forces are applied to retainer 62 , the spring comprising resilient member 60 deforms outwardly such that its diameter increases. [0061] In another embodiment, now referring to FIG. 6 , resilient member 60 is an O-ring preferably formed of an elastomeric material. Retainer 62 is a collar such as a split collar having formed thereon an exterior groove 64 to accommodate secure mounting of a resilient member 60 . In this embodiment elongated member 52 has a frustoconical section 56 adjacent proximal head 54 such that resilient member 60 and retainer 62 are firmly engageable between the frustoconical section 56 of elongated portion 52 and the end 28 of projection 22 . As forces are applied to retainer 62 , the O-ring comprising resilient member 60 deforms outwardly such that its diameter increases. [0062] The substantially constant radii articulation surfaces of the head 54 and socket 38 are configured and sized to be nestable against one another and articulatable against one another, to enable adjacent vertebral bones (against which the baseplates 10 and 30 are respectively disposed in the intervertebral space) to articulate in flexion, extension, and lateral bending. More particularly, the artificial disc implant of the present invention is assembled by disposing the baseplates 10 and 30 such that the vertebral body contact surfaces 80 , 82 are directed away from one another, and the articulation surfaces (head 54 and socket 38 ) are nested against one another such that the concave arc of socket 38 accommodates the convex arc of head 54 . [0063] While there has been described and illustrated specific embodiments of an artificial disc, it will be apparent to those skilled in the art that variations and modifications are possible without deviating from the broad spirit and principle of the invention. The invention, therefore, shall not be limited to the specific embodiments discussed herein.

1a

BACKGROUND [0001] 1. Field of the Invention [0002] The present invention relates to medical diagnostic equipment, and more particularly to medical diagnostic equipment related to the measurement and interpretation of blood pressures. [0003] 2. Description of the Related Art [0004] The effects of high blood pressure continues to be a serious health problem. In the early 1990's, it was reported that two-thirds of Americans die with atherosclerotic blood vessels and that one-half of all Americans die as a result of these lesions. [0005] There are many possible causes of high blood pressure each relating to different physiological mechanisms. In response, different hypertensive pharmaceuticals have been developed, each targeting one or more of the potential mechanisms. Examples are calcium channel blockers, angiotensin-converting enzyme inhibitors, beta-blocking drugs and their hybrids, diuretics, centrally-acting alpha 2 agonists, alpha 1 -blocking agents, vasodilators, and adrenergic-blocking agents. Some of these medications act primarily on the microvascular (peripheral) resistance to blood flow, others on the lowered distensibility of larger arteries, cardiac output, or on various combinations of these. [0006] Medical doctors and other practitioners routinely determine systolic and diastolic blood pressures using an inflatable cuff and sphygmomanometer and measure heart rate by manual timing of the pulse. Possible disease states are inferred from these values and this may lead to the use of additional diagnostic tests. The additional tests, such as measurement of cardiac output, for example, are often more invasive, time-consuming, and expensive. For these reasons, practitioners may prescribe medicines without performing them. This less-than-optimal therapy increases the likelihood of adverse side effects and when more than one agent is involved, increases the potential for undesirable drug interaction. [0007] Clearly, in deciding on which type of hypertensive medication to prescribe for a particular patient, it is desirable to identify the underlying causes so that an informed decision, based on an accurate and timely diagnosis, can be made. SUMMARY [0008] The present invention provides a method and associated apparatus, which combine measures of systolic and diastolic blood pressure and pulse frequency (heart rate), producing quantitative data on normalized diastolic distensibility, normalized peripheral resistance, and a parameter based on these which is independent of cardiac output. These results can be compared with normal and abnormal results from recorded empirical data. [0009] In one aspect of the present invention, the method can include measuring, with standard or automatic equipment, the systolic and diastolic blood pressures, and pulse frequency (heart rate) of a patient; entering, electronically or with a keyboard, the data into a preprogrammed computer; reading from the computer display, normalized diastolic distensibility and normalized peripheral resistance, the product of theses two quantities, and the relation of these quantities to stored normal or abnormal distributions of such quantities for comparable individuals plus a list of medications that are indicated in those abnormal conditions. [0010] In another aspect of the present invention, a medical diagnostic method using systolic and diastolic blood pressures, and pulse frequency of a patient is provided to compute a normalized diastolic distensibility value and a normalized peripheral resistance value, and to compute the product of the normalized diastolic distensibility value and the normalized peripheral resistance value to generate a first product value. The first product value is compared to a stored distribution of normalized diastolic distensibility and normalized peripheral resistance values for comparable individuals to determine if the first product value is equivalent to a value determined to indicate an abnormal condition. [0011] The field of the present invention relates to measuring and interpreting blood pressures, bp, and pulse rate, f, in terms of hardening of the arterioles vs. peripheral resistance to blood flow. The venue for these actions can be a medical practitioner's office or any inpatient or outpatient location. The present method departs from current procedures by measuring blood pressure and pulse rate and deducing normalized values of arterial distensibility and peripheral resistance without using a transesophageal transducer or catheter insertion in a blood vessel. [0012] The scope of the invention is defined by the claims, which are incorporated into this section by reference. A more complete understanding of embodiments of the present invention will be afforded to those skilled in the art, as well as a realization of additional advantages thereof, by a consideration of the following detailed description of one or more embodiments. Reference will be made to the appended sheets of drawings that will first be described briefly. BRIEF DESCRIPTION OF THE FIGURES [0013] FIG. 1 is a simplified illustration of a block flow diagram illustrating an embodiment of the present invention; [0014] FIG. 2 is a plot of average aortic pulse wave velocity vs. age; [0015] FIG. 3 shows volume vs. pressure plots for human aorta and vena cava; [0016] FIG. 4 shows distortion over time of the arterial pressure pulse from the aortal pulse; [0017] FIG. 5 shows cross-section sizes of various blood vessels; [0018] FIG. 6 gives the distribution of intravascular pressures; [0019] FIG. 7 gives the pulse rate and blood pressures of a 64-year-old patient in mornings during a four-month period while the patient's hypertension medications were being changed; [0020] FIG. 8 shows blood pressure and pulse rate readings during evenings of the four-month period referred to with regard to FIG. 7 ; [0021] FIG. 9 shows measurement of AM normalized micro-peripheral resistance; [0022] FIG. 10 shows AM normalized arterial distensibility; [0023] FIG. 1I shows PM normalized micro-peripheral resistance; [0024] FIG. 12 shows the Range of Systemic Arterial Pressures vs age; [0025] FIG. 13 shows Normal Micro-Peripheral Resistance Ranges where the upper limits correspond to borderline hypertension, and the lower limits to borderline hypotension; [0026] FIG. 14 . shows normalized peripheral resistance vs. age; [0027] FIG. 15 shows the range of normalized arterial distensibility for a pulse rate of 70 per minute, where limits correspond to borderline hypertension (bottom) and borderline hypotension (top); [0028] FIG. 16 shows the range of normalized arterial distensibility for a pulse rate of 90 per minute, where limits correspond to borderline hypertension (bottom) and borderline hypotension (top); [0029] FIG. 17 shows limits of the product of normalized distensibility and normalized peripheral resistance for 70 beats/minute; and [0030] FIG. 18 shows a correlation between distensibility and peripheral resistance. [0031] Embodiments of the present invention and their advantages are best understood by referring to the detailed description that follows. It should be appreciated that like reference numerals are used to identify like elements illustrated in one or more of the figures. DETAILED DESCRIPTION [0032] At each ventricular ejection contraction, a volume of blood, the stroke volume is injected into the aorta. The aorta stretches to accommodate the stroke volume and an accompanying pressure pulse launches down the aorta into the main arteries. FIG. 2 shows a plot 200 of the velocity of a pulse along the major arteries as a function of the age of an individual. The pulse can travel at speeds of between about 5-10 meters/sec—the lower speeds typically applying at lower ages and the higher speeds applying at higher ages. Since a typical pulse rate is of the order of one pulse per second, the high pulse velocity indicates that to a first approximation, the entire arterial tree feels the same pressure practically simultaneously. [0033] The pressure in the arterial tree is related to the distension of the arteries. As shown in FIG. 3 , over a wide range of pressures, the plot 302 of the relation between the blood volume (distension) and the pressure is linear as contrasted with the plot 304 representing low-pressure veins. Accordingly: δ V i =D i δP   [1] where δV i denotes the change in volume in the i th artery due to a pressure change δP, and D i denotes the distensibility of the i th artery. [0034] The pressure in the arterial tree does not remain elevated after injection of a stroke volume of blood, because the pressure drives the blood from the arterial tree into the microvasculature. [0035] As shown in FIG. 4 , the time course of the pressure in the arterial tree changes slightly from the aorta plot 402 to the plot 404 of the outlying main arteries. The change in the time course has been ascribed to reflections from branching points, selective damping of higher frequency components, and dispersion due to frequency-dependent phase velocities. The rise time of the pulse is so much shorter than the decay time that in the lowest approximation it can be assumed that the stroke volume is injected instantaneously into the arterial tree. After injection, the blood volume V in the arterial tree is assumed to decrease at a rate proportional to the pressure in the tree, since it is this pressure that causes the blood to flow from the tree. dV/dt=−P/Z   [2] [0036] Here, Z denotes the resistance to flow presented by the microvasculature fed by the arteries. This gives an exponential pressure decline—a smoothed version of the arterial pressure decline seen in FIG. 4 . At any instant, the pressure P is equal to the pressure that exists just before the stroke volume is injected into the tree—i.e. the diastolic pressure P D , plus the pressure δP of eq. [1] P=P D +δP   [3] [0037] Similarly, the instantaneous volume of the arterial tree is equal to the sum of the volume just before a stroke volume is injected, V D , plus the sum of the volumes δV i of eq. [1] V=V D +ΣδV i   [4] [0038] On inserting [1] and [3] into [2] dδP/dt =−(1 /DZ )( P D +δP )  [5] where D=ΣD i   [6] the sum being over the body arteries. The general solution to equation [5] is δ P−P D +C exp(− t/DZ )  [7] [0039] The constant C can be evaluated at t=0 where it is known that by definition the increment in pressure is equal to the difference between the systolic pressure P S and the diastolic pressure P D δP ( t= 0)= P S −P D   [8] [0040] Accordingly, C=P S   [9] and so P=P D +δP=P S exp(− t/DZ )  [10] [0041] If the pulse rate, f, is some number of pulses per minute, then the end of the period, t, occurs when t=1/f. At that time, the pressure must once again be the diastolic pressure P D . Thus, the relationship can be shown as: P S =P D exp(1 /DZf )  [11] [0042] Since the arterial distensibility D, peripheral resistance Z, and pulse rate f, all enter into the exponent in this relationship, the ratio of systolic to diastolic pressure can depend sensitively on these parameters. [0043] At t=0, the total change in volume from the diastolic volume (the volume just before injection of the stroke volume) must be equal to the stroke volume V S . Equation [1] then shows (on using eq. [8]) that: V S =D ( P S −P D )  [12] The cardiac output <dV/dt> is the product of the pulse rate and the stroke volume. Then <dV/dt>=fD ( P S −P D )  [13] From [13] and [11]: Arterial distensibility: D=<dV/dt>[f ( P S −P D )] −1   [14] Peripheral resistance Z =( P S −P D )[< dV/dt> ln( P S /P D )] −1   [15] Equations [14] and [15] show that: D N =D/<dV/dt>=[f ( P S −P D )] −1   [16] R N =Z<dV/dt>= ( P S −P D )[ln( P S /P D )] −1   [17] [0044] The left sides of [16] and [17] are respectively, normalized distensibility, D N , and normalized peripheral resistance, R N . As shown, these terms are expressible solely in terms of quantities routinely and easily measured in local medical offices and represent parameters which are normalized by cardiac output. The product of these values DR=D N R N , is independent of cardiac output. The significance and utility of eqs. [16] and [17] derives from records of their values in association with several medical conditions. [0045] The normal reference values of blood pressures for typical subjects are shown in FIG. 13 . If the values of diastolic pressure and systolic pressure at the boundaries of the normal range are taken, then the corresponding normal values for D N and R N are as shown in FIGS. 14-16 . [0046] The R N is independent of pulse rate, while the D N depends on pulse rate. FIG. 15 shows the values of D N for a pulse rate of 70 per minute and FIG. 16 shows the values for D N for a pulse rate of 90 per minute. Also shown on each plot are two double-ended arrows, indicating the range of values for the morning and evening readings for a subject. [0047] FIG. 17 shows that the normal values of D N and R N fall within in a narrow range. This is in contrast to the values obtained on one hypertensive subject over the time period of several months which were found to vary widely about the reference values. [0048] FIG. 1 shows the entry and processing of blood pressure numeric data 102 and pulse rate numeric data 104 into a computer 106 . A wide variety of analog or digital computers may be used, such as hand-held, laptop, or desktop computers, the selection turning mostly on clinical convenience. The blood pressure data 102 can be gathered from a standard inflatable cuff and sphygmomanometer. The pulse rate data 104 can be gathered by manual timing of the pulse or from automatic equipment that can deliver the data electronically to computer 106 . [0049] The systolic and diastolic pressures, expressed numerically in a consistent set of units, for example, torr, are entered into computer 106 . The difference between these pressure numbers is produced and then divided by the natural logarithm of their ratio. The result is the R N . [0050] In the embodiment shown in FIG. 1 , unity gain amplifiers 108 and 110 , produce differences of input numbers, indicated by arrowheads 112 . Conventional logarithmic elements 114 and 116 produce natural logarithms of their input numbers. Conventional multipliers, 118 , 120 , 122 , and 124 , produce the products of two input numbers each. Amplifiers 126 and 128 , each of gain G>>1, produce division of input numbers. The output of amplifier 126 , Co for instance, is Co=G·(P S −P D )−G·[ln(P S )−ln(P D )]·Co. Solving for Co gives Co=G·(P S −P D )/{1+G·[ln(P S )−ln(P D )]} which, because G>>1 gives Co≈(P S −P D )/[ln(P S )−ln(P D )]=(P S −P D )/ln(P S /P D )=R N , normalized peripheral resistance. In like manner, the output of amplifier 128 is Do=1/[(P S −P D )·f]=D N , normalized arterial distensibility, where f is in units of beats per minute, for example. These two outputs and their product D N R N are applied to a standard display device 130 , which includes analog to digital converters producing called out numbers on the appropriate abscissa, as indicated in FIG. 1 . [0051] The three histograms 132 , 134 and 136 shown in FIG. 1 display statistical data taken from a collection of similar individuals. For example, the statistical data can be taken from the first month of the patient's examinations (21 exams during this period), the idea being to substitute the ensemble average by a time average, the ergotic hypothesis of statistical mechanics. [0052] The utility of these normalized measures is given in an example of a hypertensive scleroderma patient for whom values for blood pressure readings, heart rate, D N , and R N obtained over a four month period are displayed in FIGS. 7-12 . In this patient, before adequate treatment, the value for DR was below normal, the value for R N was within normal limits and the value for D N was below normal. The patient's range of these values is displayed with reference to normal values in FIGS. 14-15 . It can be inferred from these values that his hypertension was due to a decrease in normalized artery distensibility rather than to scieroderma-related increase in normalized peripheral resistance. These results would guide a clinician to select those drugs which inhibit vasoconstriction rather than those which address increased cardiac output such as beta-blockers and diuretics. Routine and automatic recording of the parameters, thus building a statistical database, would be a useful diagnostic adjunct to individual blood pressure and pulse rate readings thereby improving monitoring for therapeutic efficacy. [0053] FIG. 18 shows the correlation between D N and R N in the first 24 exams. Unlike these data, the single points indicated by the arrows in the Peripheral Resistance and Arterial Resistance histograms of FIG. 1 were taken near the end of the four-month examination period where hypertension was under control. Arterial Distensibility, D N , increased and Peripheral Resistance, R N , decreased because of the correlation between them. [0054] Although the present invention is described with reference to the presently preferred embodiments, it is understood that the invention as defined by the claims is not limited to these described embodiments. Various other changes and modifications to the invention will be recognized by those skilled in this art and will still fall within the scope and spirit of the invention, as defined by the accompanying claims.

1a

FIELD OF THE INVENTION [0001] This invention relates generally to the field of safe and effective pest elimination. More particularly, this invention relates to ant-pest elimination and uses a combination of a device and safe chemical component. BACKGROUND OF THE INVENTION [0002] Generally, we consider ants to be pests when found inside a house. However, ants are a beneficial insect when found in their natural environment. Ants dispose of dead and decaying plant and animal organic matter. Ant nests aerate the soil. [0003] As is well known, ants will eat just about anything, which is one reason they're such pests inside a residence. Ants, in great numbers, will carry back meat, sweets, plant and/or animal materials to their nests. Foods containing greasy proteins or sugars are especially attractive to ants. Such foods can draw ants in large numbers. [0004] As is well understood, the ants foraging in the residence are worker ants charged with bringing food back to their colony mates. As is also well, known, such worker ants leave behind a trail for their nest mates to follow by depositing a pheromone as they walk. Unless purposely removed, the pheromone trail stays in place for a long, long time. [0005] Various chemical insecticides have been found to effectively kill ants for a short period of time. As homeowners know, the initial kill doesn't last long enough. After a while, the ants return in at least in the same numbers as before. While the ant problem hasn't gone away, the environment may have been detrimentally affected. Various pesticides can last 50 years or more and create havoc in the environment. [0006] Other non-toxic approaches have also been attempted and are just good common sense for any ant infestation. Such approaches include the following: [0007] Storing all attractive food items such as any sugars, syrup, and honey in closed containers; [0008] Rinsing out soft-drink containers before placing food items in the trash; [0009] Cleaning up grease splatters and spills as soon as they happen; [0010] Resisting the convenience of free-feeding pets—ants find kibbled animals foods especially irresistible; and [0011] Scrubbing ant entry points with soap and water—this removes trail pheromones and make it more difficult for foragers to find previous trails. [0012] Ants will not eat bait, if foods, as described above are nearby and easily foragable. For the best results, sinks, pantries, and other areas of possible ant-infestation, should be free of food particles and other ant-attractive substances. [0013] There is no question that ants are an annoyance when found inside a residence. They are unsightly and give the homeowner a feeling that he's been invaded by an alien species. It is quite a ghastly sight, first thing in the morning, to see 10,000 or more ants chopping down on leftover pizza from the previous night. It's enough to make one miss the first and most important meal of the day. [0014] On the other hand, ants are beneficial outside the home and there is no reason to poison them to extinction, should such even be possible. Thus, there is a need for non-toxic methods of eliminating the ant pest from homes without poisoning the environment What is needed is an environmentally friendly, non toxic method of eliminating ants, whether they be found in a residence or plant garden or any other undesirable locations. SUMMARY OF THE INVENTION [0015] The structure for an improved ant trap in accordance with the present invention takes different forms. In some embodiments, the ant trap includes electro-mechanical devices, where a motor moves the platform having an ant path into a liquid toxic to ants, but environmentally safe. In another exemplary embodiment, there is only a passiVe trap, which is triggered .by the weight of the ants themselves. Finally, yet another embodiment includes a platform, which remains passive which the liquid is cycled. [0016] It is an object of this invention is to provide an environmentally safe and effective method of eliminating ant-pest in the home. [0017] It is another object of this invention to provide an ant trap, which can be used safely around pets and humans, while effectively eliminating ant infestations. [0018] In accordance with the objects set forth above and as will be described more fully below, the ant trap in accordance with this invention, comprises: [0019] a base having a central opening and the central opening suitable for storing liquid; [0020] a bait trap located within the central opening; and [0021] a platform movable with respect to the central opening, in a first position the platform forms an ant path from the base to the bait trap, in a second position, at least a portion of the platform moves within the central opening; [0022] whereby upon filling the central opening with a liquid and upon selectively moving the platform into the liquid the ant path immersed in the liquid for exterminating ants. [0023] In another exemplary embodiment, the ant trap, comprises: [0024] a base; [0025] a platform movable with respect to the base; [0026] a bait trap located on the platform, an ant path is defined from the base along the platform to the bait trap; and [0027] a sweeper mechanism for gathering ants on the ant path as the platform moves with respect to the base. [0028] In another exemplary embodiment, the ant trap, comprises: [0029] a base having a central opening and the opening suitable for storing liquid; [0030] a platform movable with respect to the base, the platform being balanced with respect to the base and pivotable thereto, the platform having pivot points located asymmetrically with relation to the base; [0031] a bait trap located on the platform, the bait trap aiding in balancing the platform with respect to the base, the ant path is defined from the base along the platform to the bait trap; [0032] the balance of the platform being such that the weight of a sufficient number of ants on the platform, causes the platform to tilt into the central opening; and [0033] whereby upon filling the central opening with a liquid and upon the balance being upset, the platform pivots and the ant path is at least partially immersed in the liquid for exterminating ants. [0034] In another exemplary embodiment, the ant trap, comprises: [0035] a base having a central opening and the, opening suitable for storing liquid; [0036] a platform located proximate to the central opening; [0037] a bait trap located on the platform and elevated above the platform; and [0038] a reservoir connected to the base and communicating with the central opening, the reservoir having a valve for selective communication with the central opening; [0039] a pump member for pumping liquid from the central opening back to the reservoir. [0040] It is an advantage of the ant trap in accordance with the instant invention to provide a safe and effective means for eliminating ant infestations. BRIEF DESCRIPTION OF THE DRAWING [0041] For a further understanding of the objects and advantages of the present invention, reference should be had to the following detailed description, taken in conjunction with the accompanying drawing, in which like parts are given like reference numerals and wherein: [0042] FIGS. 1-3 illustrate the first two exemplary embodiments of the ant trap in accordance with this invention. [0043] FIG. 4 illustrates another exemplary embodiment of the ant trap in accordance with this invention in cross section. [0044] FIG. 5 illustrates another exemplary embodiment of the ant trap in accordance with this invention shown in perspective. [0045] FIGS. 6 & 7 illustrate another exemplary embodiment of the ant trap in accordance with this invention. [0046] FIGS. 8 & 9 illustrate another exemplary embodiment of the ant trap in accordance with this invention. DETAILED DESCRIPTION OF THE INVENTION [0047] In order to appreciate the invention herein, one must appreciate the need in the art as set forth in the Background. Most importantly, the structure herein for resolving the long felt need to eliminate ant pest infestations in the home without causing environmental damage is represented by the various exemplary embodiments in accordance with the disclosed invention. [0048] With particular reference to FIGS. 1-3 , there is shown an exemplary embodiment of the ant trap denoted by the numeral 20 . Illustrated in FIG. 1 is the first exemplary embodiment, which includes a base 30 , an ant pathway 34 on a movable platform 36 , a bait station 38 and structure for moving the platform 36 , generally indicated by numeral 40 ( FIGS. 2 & 3 ). [0049] Additionally, the ant trap 20 includes a timer 42 and an on/off switch 44 . These elements are connected to the structure 40 . The structure 40 of FIGS. 1-3 , includes an electro-mechanical lift 50 for raising and lowering the platform 36 . The lift mechanism includes a motor 52 , connected to a power source 54 through wires 56 . [0050] Based upon a variety of factors, timing is set for activation of the lift 50 . Upon, activation, the lift 50 lowers the platform 36 toward the base 30 . [0051] As shown in FIGS. 1-3 , the base 30 has a central opening 32 , filled with a liquid. Typically, such a liquid is one that would be immediately harmful, even fatal, to an ant. For example, a liquid of water and sweet boric acid is preferable. This liquid is immediately harmful to the ants, while not being toxic to the environment or to mammals in the residence. [0052] The central opening 32 if filled with, for example, with a liquid made of sweet boric acid and water. However, it will be appreciated that other liquids within the spirit and scope of the invention herein. For example, although not quite as effective, simple water will suffice. [0053] It has also been found to be useful to sprinkle the ant path, the pathway 34 and the entire base 30 and platform 36 with powdered boric acid. Whatever ants do escape bring back healthy amounts of boric acid into the nest and often leads to a lessening of the ant population in the nest or complete eradication in some cases. All of this done without harm to humans or other mammals as well as the environment. [0054] As shown particularly in FIG. 1 , ant will fill the pathway 34 in their efforts to forage for food. Periodically, based upon the timer 42 , the entire platform 36 is submerged in the liquid of the central opening 32 . Ants will drown or otherwise, from the sweet boric acid solution, have their air holes clogged and similarly die. Their bodies sink to the bottom of the central opening 32 , while upon signal from the timer 42 , the platform 36 is raised once again and forms pathway 34 for the ants to reach the bait 60 . [0055] Although, unknown to the ants, the movable platform serves as the delivery system by which boric acid is delivered to the ants and the ants delivered to the liquid. It is well known that despite the witnessing of the lowering of such a platform, as long as there is food to forage, the ants will continue to board the platform, completely unmindful of the danger which awaits. Their programming for food is above their own need for survival. [0056] The base 30 includes a central stanchion 37 , rising from the floor 39 of the central opening 32 . The stanchion 37 is suitably configured so that bait or even food can be spread out for ants and boric acid powder can be sprinkled around so that the ants must crawl through it to get to the bait. Should any ants escape the trap and return to the nest, they will bring the boric acid with them causing further destruction of the nest. [0057] The exemplary embodiment illustrated in FIG. 3 , includes a transducer 70 and a motion detector 72 . The motion detector monitors activity at or near the bait. Upon the motion detector 72 sensing a high level of activity, it can be assumed that the ant pathway 34 is filled and the platform 36 , is lowered. [0058] Upon being lowered, the transducer 70 is activated. The transducer causes increased wetting of the ants and allows even more effective elimination of the ants. Obviously there are increased costs and the user will need to weigh and balance the increased effectiveness with the increased costs. [0059] Notice that in either embodiment shown with respect to FIGS. 1-3 , the stanchion portion holding the bait remains above the liquid line and thereby keeps the bait dry. [0060] In the exemplary embodiment with respect to FIG. 4 , the ant trap is generally denoted by the numeral 100 . The ant trap 100 includes a base 130 , an ant pathway 134 on a movable platform 136 , a bait station 138 and structure for moving the platform 136 , generally indicated by numeral 140 . [0061] Additionally, the ant trap 100 includes a timer (not shown) and an on/off switch (also not shown). These elements are connected to the structure 140 . The structure 140 includes an electrical motor 152 for rotating the platform 136 . The motor 152 , is connected to a power source 154 through wires 156 . [0062] Based upon a variety of factors, timing is set for rotation of the platform 136 . The platform 136 is rotated 180 degrees. Upon, activation, the platform 136 rotates leaving ants on the ant path 134 in the liquid. [0063] The base 130 has a central opening 132 , filled with a liquid. Typically, such a liquid is one that would be immediately harmful, even fatal, to an ant. For example, a liquid mixture of water and sweet boric acid is preferable. This liquid is immediately harmful to the ants while not being toxic to the environment or to humans or mammals in the residence. [0064] The central opening 132 if filled with, for example, with a liquid made of sweet boric acid and water. However, it will be appreciated that other liquids within the spirit and scope of the invention herein. For example, although not quite as effective, simple water will suffice. [0065] It has also been found to be useful to sprinkle the ant path, the pathway 134 and the entire base 130 and platform 136 with powdered boric acid. Whatever ants do escape bring back healthy amounts of boric acid into the nest and which often leads to a lessening of the ant population in the nest or complete eradication in some cases. Again, the objective of ant elimination is accomplished without harm to humans or other mammals or the environment. [0066] Similarly to the exemplary embodiment illustrated in FIG. 3 , the ant trap 100 in one embodiment also includes a transducer and a motion detector (not shown). The function of each of these elements is the same as that described with respect the earlier embodiments of FIGS. 1-3 . [0067] With respect to FIG. 5 , there is shown another exemplary embodiment of the ant trap, generally denoted by the numeral 200 . As with the earlier described embodiments, the FIG. 5 embodiment includes a base 220 and a platform 222 . [0068] The, ant trap 200 additionally includes a sweeper mechanism generally denoted by the numeral 230 . The sweeper mechanism 230 includes a sweeper 232 , an upstanding stanchion 234 . The sweeper 232 is fixedly attached to an arm 236 . Additionally, the arm 236 is fixedly connected to the stanchion 234 . [0069] The ant trap 200 additionally includes a support arm 238 and a motor 240 above the support arm 238 and platform 222 . The support arm 238 supports the suspended motor 240 . The ant trap 200 includes a power supply 250 and wires 252 connecting the power supply 250 to the motor 240 . [0070] Upon being activated, the motor 240 causes the stanchion 234 to rotate in the direction indicated by the arrow in FIG. 5 . Consequently, the sweeper 232 rotates in the same direction. As the sweeper 232 rotates, ants on the platform 222 are caught in the sweeper 232 . [0071] In order to increase the effectiveness of the sweeper 232 at removing ants on the platform 222 , the sweeper 232 is made from a wettable material. The material is for example a fabric as shown in FIG. 5 . The material is wetted with a liquid solution that is both harmful, even fatal to the ants, while being safe for mammals and the environment. For example, the material is treated with a liquid solution of sweet boric acid. [0072] In the exemplary embodiment of FIG. 5 , the arm 238 includes a reservoir 260 of the liquid solution described above. The reservoir 260 has one or more openings (not shown) communicating directly with the fabric. The openings are quite small and as a result the liquid slowly drips onto the fabric of the sweeper 232 keeping the, sweeper 232 moist at all times. [0073] The ant trap 200 additionally includes a bait trap, 270 mounted on the central portion of the platform. In the embodiment shown, the bait trap 270 is located where the stanchion 234 connects to the platform 222 . [0074] With respect to FIGS. 6 and 7 , there is shown another exemplary embodiment of the ant trap generally denoted by the numeral 300 . As described with regard to the earlier embodiments, the ant trap 300 includes a base 320 and a rotatable platform 322 . The base 320 in this embodiment is generally rectangular and has a central opening 324 . The central opening 324 stores a liquid, as described above. [0075] The platform 322 acts as a rocker platform. The platform 322 includes pivot points 340 . The pivot points 340 are located toward one of the base 320 . The platform is lightweight and is delicately balanced. [0076] The platform 322 includes a bait trap 330 . The bait trap 330 is positioned on the platform 322 to balance the platform and to create a situation where the maximum number of ants are on the “dipping” side 350 of the platform. Upon a sufficient number of ants on the dipping side 350 , the delicate balance is disturbed and the dipping side 350 dips into the liquid with the results previously described above. The liquid is as described with respect to the earlier embodiments. [0077] With respect to FIGS. 8 and 9 , there is shown another exemplary embodiment of the ant trap, generally denoted by the numeral 400 . The ant trap 400 includes a base 420 having a central opening 422 . Attached to the base 420 is a reservoir mechanism, generally denoted by the numeral 430 . [0078] The reservoir mechanism 430 includes a reservoir tank 440 attached to the base 420 . The tank 440 includes an outflow valve 442 operated by a solenoid 444 . Wires 446 connect the solenoid with a power source. Liquid of the type earlier described fills the tank 440 . [0079] The ant trap 400 includes a bait trap 448 , centrally located in the central opening 422 to attract the maximum number of ants into the central opening 422 . [0080] In one exemplary embodiment, a timer (not shown) similar to the timer shown in FIGS. 1-3 is connected the solenoid. Periodically, the solenoid releases the liquid in the reservoir tank 440 . The liquid floods the centrally opening terminating the ants found therein. [0081] The ant trap 400 includes a pump (not shown). The pump is activated to drain the water from the central opening 442 through outlet 450 , which opens upon activation of the pump. The ant-laden water is pumped through the outlet 450 and the return water is pumped back into the tank 440 . Since the dead ant don't float, their bodies fall into a collection area 460 . The collection is manually cleaned as needed. [0082] While the foregoing detailed description has described several, exemplary embodiments of the ant trap in accordance with this invention, it is to be understood that the above description is illustrative only and not limiting of the disclosed invention. Thus, the invention is to be limited only by the claims as set forth below.

1a

CROSS REFERENCES TO RELATED APPLICATIONS This application is a Continuation in Part of PCT/AU03/00936 filed on Jul. 24, 2003. TECHNICAL FIELD OF THE INVENTION This invention relates to a device for detecting insects and pests and in particular, detecting the presence of insects in a bait station. BACKGROUND OF THE INVENTION The destructive nature of pests, in particular termites, which ingest the wood of structures and other materials, is well known. The detection of the presence of termites and pests is vital in controlling and abating pest infestation in an area. There are numerous conventional devices which detect the presence of termites or pests. One such device is described in U.S. Pat. No. 5,555,672 wherein a termite detection and control system is provided by a subterranean bait station. The bait station comprises removable cartridges having partitions containing bait material to attract termites. Once termite presence is detected, the bait in one of the cartridges is replaced with bait induced with pesticide. Another apparatus is described in Australian Patent 708025. A cellulose monitoring device is housed in a durable station housing which is periodically observed to detect activity of isopteran insects. The insects are eliminated using a toxicant-containing matrix enclosed in the durable station housing. A further termite bait apparatus is known from U.S. Pat. No. 5,778,596. The apparatus has two compartments, a non toxic and a toxic compartment. A passage, initially blocked by a plug which the termites can eat through, connects the two compartments. Termites placed in the non toxic compartment feed on non-toxic food. An exit from the non-toxic compartment leads to the shelter of a target termite colony. The target termite colony then slowly enters the non-toxic compartment and eventually the toxic compartment. Yet another bait station is described in U.S. Pat. No. 6,195,934. A termite bait station uses a cellulose bait impregnated with a slow acting toxicant to control and eliminate termites. The above systems and methods detect the presence of termites and pests in an area and eradicate them using toxicant-bait. However, these systems require constant visual monitoring of the bait stations to ascertain the presence of pests and termites. Often, termite colonies and pests are well established before they are detected. The above systems are limited to the detection of insects and generally are not extendible to small animals such as mice and rodents. OBJECT OF THE INVENTION It is an object of the invention to provide an improved bait station for detecting the presence of insects and pests. SUMMARY OF THE INVENTION In one form, although it need not be the only or indeed the broadest form, the invention resides in a bait station comprising: a housing; at least one cavity formed within said housing; a plurality of openings for permitting insects or small animals to enter and exit said bait station; at least one electromagnetic radiation element generating an electromagnetic field in said at least one cavity; at least one electromagnetic receiving element detecting the electromagnetic field in said at least one cavity; wherein the at least one electromagnetic receiving element detects changes in the electromagnetic field in said at least one cavity caused by the ingress or egress of said insects or said small animals. Preferably the bait station comprises an inner cavity and an outer cavity formed within said housing. Suitably the bait station further comprises at least one opening formed in a wall of each of the inner cavity and outer cavity for insects or small animals to enter and exit said bait station. Preferably the inner cavity is contained within and is coaxial with the outer cavity. The outer cavity may be formed by an outer wall of the housing. Preferably there is at least one electromagnetic radiation element in each of said inner and outer cavities, and at least one electromagnetic receiving element in each of said inner and outer cavities. The bait station may include memory means that stores data including one or more of: received electromagnetic field, status of said cavities, status of a bait dispenser and a battery status. The electromagnetic field received at the electromagnetic receiving elements may be processed for storing as digital data in the memory. Activity in the bait station such as change in electromagnetic field in the cavities can be sent to a remote location via an onboard bidirectional RF link in the bait station. The electromagnetic receiving element may be interrogated periodically or on demand by a processor. Preferably, the electromagnetic receiving elements operate in a standby mode until an activity such as a change in the electromagnetic field is detected. In another aspect of the invention there is provided a method of detecting the presence of insects or small animals in a bait station having a housing, at least one cavity formed in the housing and a plurality of openings permitting ingress or egress of said insects or said small animals, said method including the steps of: generating an electromagnetic field in at least one cavity formed within the housing of said bait station; and detecting a change in the electromagnetic field in said at least one cavity caused by the ingress or egress of said insects or said small animals. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a schematic view of a first embodiment of a bait station in accordance with the invention; FIG. 2 is a detailed schematic illustration of a bait station in accordance with the first embodiment of the invention; FIG. 3 is a block diagram of an embodiment of a transmission circuit of a bait station in accordance with the invention; FIG. 4 is a block diagram of a receiver circuit of a bait station in accordance with the invention; FIG. 5 is a block diagram of a signal acquisition circuit of the bait station in accordance with the invention; FIG. 6 is a block diagram of a control circuit of the bait station in accordance with the invention; and FIG. 7 is a schematic view of a second embodiment of a bait station in accordance with the invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT In a preferred form, the invention will be described with reference to a bait station having inner and outer cavities suitable for termites and other pests. However, it should be noted that the invention can also be realised with a single cavity and the bait station can be used for small animals. In a preferred form of the invention, there is generally shown in FIG. 1 a schematic view of a bait station 1 having a housing 2 . An inner cavity 3 is contained within and is coaxial with an outer cavity 4 formed with an outer wall of housing 2 . A bait dispenser 5 contains a bait to attract insects and termites for detection and capture. The bait may contain toxicants to eradicate the termites. An electronics compartment 6 encloses a power supply and electronics for generating, detecting and processing electromagnetic radiation signals. Referring now to FIG. 2 , the bait station 1 further includes inner cavity openings 7 a and outer cavity openings 7 b formed in the respective walls to permit termites to enter and exit each of the inner cavity 3 and outer cavity 4 . The number of cavity openings can vary depending on the application of the bait station. In the case of detection of termite activity in an area, two or more cavity openings are suitable. The bait station is provided with inner cavity electromagnetic radiation elements, in the form of transmission antenna 8 contained in the inner cavity 3 , and outer cavity electromagnetic radiation elements, in the form of transmission antenna 9 contained in the outer cavity 4 . The electromagnetic antennas can take the form of a loop or dipole tuned to the required frequency of operation. Corresponding inner and outer cavity electromagnetic receiving elements 10 and 11 in the form of receive antennas, receive the electromagnetic signal transmitted by the respective transmission antennas, 8 and 9 . For simplicity the signal transmission lines between the electronics compartment 6 and the antennas 8 , 9 , 10 , 11 have been omitted. The housing 2 of the bait station 1 may be formed with an outer metallised cover defining the outer cavity 4 . Similarly, the inner cavity may also be formed from a metallised structure. The electromagnetic field generated in the cavities may involve microwave frequencies. The metallised structures of the cavities isolate the microwave field in the respective cavities. As will be well known to a person skilled in the art, metallic material provides an effective shield from microwave radiation. Alternatively, other suitable materials can be used, such as hardened (metallised) plastic or the like which termites cannot ingest. The transmission antennas 8 and 9 for the respective inner and outer cavities may be of loop or dipole configuration. Referring to FIG. 3 , a transmission circuit 12 of the bait station is shown. Antennas 8 and 9 are energised by a voltage controlled oscillator (VCO) 13 . The output frequency of VCO 13 is amplified by amplifier 14 and tuned to a resonance frequency of the cavities by an Automatic Frequency Control (AFC) loop (not shown). FIG. 3 shows a comb generator 15 (such as Alpha CVB 1031), which produces multiple harmonics of the VCO signal, and enables the simultaneous excitation of both cavities from the same oscillator. Using this technique, the VCO 13 can operate in the 2.4 GHz band, significantly reducing costs. The VCO 13 can be locked to the peak of the resonance frequency or to a high gradient skirt of the resonance curve. The tuned output signal from the comb generator 15 is split by Wilkinson splitter 16 into two signals for the respective transmission antennas 8 and 9 . The respective signals are bandpass filtered by filters 17 and 18 and amplified by amplifiers 19 and 20 . Couplers 21 and 22 connect and supply the transmission signals T 1 , T 2 to the transmission antennas 8 and 9 , and the local oscillator drive LO 1 , LO 2 to the receiver mixers 30 and 31 (shown in FIG. 4 ). Power to the bait station is provided by a suitable battery pack. Transmission circuit 12 and battery pack may be separate from the bait station 1 or attached to the bottom (as shown in FIG. 1 ), top or side. Referring now to FIG. 4 , a bait station receiver circuit 29 is shown. Received signal RF 1 for the inner cavity and RF 2 for the outer cavity are downconverted by mixer circuits 30 and 31 respectively. The mixers are quadrature mixers, producing I and Q signals for each of the cavities. The received signals are henceforth processed as complex numbers, and converted from Cartesian to polar format by the microprocessor 24 ( FIG. 6 ). Thus magnitude and phase of the received signals is available for further processing. The downconverted signals are amplified, buffered and low pass filtered 33 as shown in FIG. 5 . The filtered signal is converted by an analogue to digital converter 34 into a digital value and stored in a flash memory 25 using standard conversion techniques. Any suitable conventional equipment housed at the bait station or located at a remote site may do the conversion. Signal acquisition circuit 32 of FIG. 5 may also receive signals from sensors detecting moisture content of the cavities, battery status, temperature, vibration or air movement and other conditions of the bait station capable of being sensed electronically. The signals are received, buffered and filtered by a four channel buffer 35 and converted to digital data by an analog to digital converter 34 . The digital data is stored in a flash memory 25 as shown in FIG. 6 . All of these functions can be performed by a single chip microconverter, such as the Analog Devices AduC834. Referring now to FIG. 6 in detail, there is shown a control circuit 23 of the bait station. Any disturbances and fluctuations in the received electromagnetic field signal at the receive antennas 10 and 11 is processed by a microprocessor 24 and stored as digital data in a memory 25 . Alternatively, the digital data can be transmitted to a remote location via an onboard bidirectional RF link 26 , for further evaluation including, status of said cavities, status of bait dispenser 5 , size of insect, number of insects, etc. Changes in the amplitude or phase of the electromagnetic field in either of the cavities can be analysed. The temporal nature of these changes and the order in which they occur in the two cavities can be used to determine insect ingress or egress and discriminate against spurious effects such as ingress of inanimate matter (dirt, water, snow etc or environmental effects such as movement, vibration). Changes which are incommensurate with these spurious effects and commensurate with temporal patterns of insect activity, indicate the likely presence of insects such as termites in cavities 3 and 4 , their numbers and type of activity (ingress, egress, or feeding). Criteria for discrimination of these changes in electromagnetic field can be fixed from laboratory experiment results. Adaptive techniques and database updates can be used to refine this detection process. Microprocessor 24 can also be programmed via EEPROM 27 . A digital to analog converter 28 converts control signals from microprocessor 24 to tune the AFC loop of the transmission circuit 12 in FIG. 3 . The bait station of the present invention allows the detection of the presence of pests and in particular termite activity in an area. The bait station does not require visual inspection by a user to determine the presence of termites. The operation of the bait station will now be described in more detail with reference to the inner and outer cavities. The inner cavity transmission antenna 8 is energised to radiate a high order mode of electromagnetic signal, such as, but not restricted to TM m1n where, m and n are mode numbers resulting in a complex pattern of electromagnetic field (Transverse Magnetic) at an inner surface of inner cavity 3 . The nulls and maxima of the field pattern are spaced by 10 to 40 mm in azimuthal and longitudinal directions. Other spacing may also be used depending on the size of insects the bait station is targeted for. Insects crawling on the inner surface of the cavity will disturb the electromagnetic field pattern whenever they move a few millimeters. It is unlikely that the insects such as termites will become airborne inside the bait station. However, the electromagnetic field pattern will still be disturbed under this condition. The inner cavity openings 6 are positioned at the nulls of electromagnetic field pattern generated by the inner cavity transmission antenna 8 . The entry of a single insect into inner cavity 3 and its traversal of the areas of field maxima and/or minima will cause a fluctuation in the electromagnetic field pattern. The receive antenna 10 will receive a time varying signal caused by the movement of the insect. This signal is then processed by microprocessor 24 so that minute changes due to the movement of the insect are detected differentially. The outer cavity antenna 9 is energised to radiate a high order mode such as, but not restricted to the TEM variety. The high order TEM (Transverse Electromagnetic) resonant mode presents a pattern of nulls and maxima whose contours are circles spaced by 10 to 40 mm in the longitudinal direction. In one form, these nulls in the electromagnetic field can be designed to be spatially offset from the nulls of the corresponding TM patterns in inner cavity 3 . Since the openings should be placed at the field nulls (in order to minimise electromagnetic coupling between the cavities) the outer cavity openings 7 can be deliberately offset from inner cavity openings 6 to discriminate against false detection due to rain, snow, dust, mud or other inanimate matter, which is subject to gravity and wind only. Such offsets are equivalent to baffles. The presence of any null between the two sets of openings guarantees that an insect will cause an electromagnetic field disturbance in the outer cavity whenever it enters or exits inner cavity 3 . In operation, if the electromagnetic field is disturbed in the outer cavity followed by increased activity in the inner cavity, then it is likely to be due to an insect entering the bait station. A reduction in the fluctuation of the electromagnetic field in the inner cavity followed by activity in the outer cavity is likely due to an insect exiting the bait station. In a typical application, the bait station may be placed on the ground at an area of investigation. The inner cavity openings can be arranged so as to prevent extraneous materials from being either deposited by insects or naturally entering the inner cavity. Over time, foreign material may accumulate in the outer cavity, thereby degrading the TEM resonance in the outer cavity. The deterioration of the TEM resonance can be detected by the receive antenna 11 . Microprocessor 24 , either housed at the bait station or at a remote site can evaluate the degree of deterioration and generate a warning message alerting a user. The outer cavity openings may also be made into baffles so that only materials carried by the insects can be carried inside the cavities other than large foreign material. A drainage hole may be provided to drain any water, snow or ice collected in the bait station. Since the outer cavity slots are placed at nulls of the electromagnetic field pattern, very little electromagnetic field leaks out as radiation. This has several important ramifications: 1. The device is able to operate as an unlicensed sensor and is thus unencumbered by regulatory constraints relating to frequency of operation. Therefore, the cavity dimensions, resonant frequency and mode structure can be tailored to the detection of insect activity. 2. Because of the containment of the electromagnetic energy, much less power is needed for the detection process. This reduces battery consumption and simplifies transmitter design and reduces costs. The low coupling to the outside world also reduces interference from external clutter and external transmitters. The processing of the received electromagnetic field signal will now be described. The signal received by receive antennas 10 and 11 may be analysed in terms of its magnitude and number of events per time interval. In this manner, the former relates to an insect size and the latter to insect number or activity of an insect. Microprocessor 24 processes the stored digital signal to evaluate conditions in the bait station. The microprocessor may also process the stored data offline. The processing may be adaptive based on a library of recorded signals, or “learned” from stored historical data, including fuzzy logic and neural nets. The processing may involve the comparison between the observed signal and fixed or adaptive thresholds. Signals exceeding such thresholds may be identified and logged as alarm conditions and their particulars may be stored in memory. In addition, alarm conditions may be used to trigger actuators used to aid in termite identification. For example, an electromagnetic, ultrasonic or electromechanical transducer or transducers, or chemical dispenser(s) may be activated to provoke (or inhibit) termite (or other insect) movement. The resulting changes in the received microwave signal may be used to improve the confidence level in the detection process, or improve the specificity of the detection with regards to the exact species of insect being detected. The details of the means of provocation may involve pulsing the said actuators at various repetition rates, with various duty cycles etc. The actual frequencies of electromagnetic disturbances may be tuned or variable, according to known information, or be adaptive, trying many combinations until a response is noticed or the variations exhausted. Any activity in the cavities as registered with the receive antennas or alarm conditions generated may be sent to a remote central processor using an onboard bidirectional RF link 26 at the bait station, as shown in FIG. 6 . In an alternate form, the receive antennas may be interrogated periodically or on demand by the remote central processor. In this way, the raw or processed data or both can be stored in a remote location safe from adverse weather conditions or tampering. The data can include information about the received electromagnetic signal at the antennas, alarms conditions such as: cavity status, bait dispenser status, battery status, etc. Each data transmission to the remote central processor carries a date and time stamp. It is expected that no activity would be detected for the majority of an observation period. Hence, to conserve battery power and memory space, the antennas are operated in a standby mode until activity that causes a change in electromagnetic field pattern is detected. In the standby mode, the antennas, RF link and microprocessor can be pulsed periodically or in a pseudorandom pattern. With the present system, it is possible to acquire an antenna reading or RF link activity within 1 ms of turn on. If no activity is detected, the next pulse can occur approximately 1 second later resulting in a maximum latency of 1 second. During inactivity in the bait station, a duty cycle of 0.001 is attainable which provides an efficient operation of the bait station. As described in detail above, detection of insects or small animals is dependent upon movement within the inner and/or outer cavity that causes disruption of the electromagnetic field, thus producing a detectable signal. It is anticipated that an enhanced signal will be obtained if the insects or small animals are provoked to greater movement. As shown in FIG. 7 , the bait station 1 may include a provocation means 36 . The provocation means 36 is shown within the inner cavity 3 , but may be elsewhere. The provocation can be achieved in a number of ways including mechanical, acoustic and chemical provocation. A mechanical provocation could be a mechanical tapper that periodically generates noise and vibration by tapping the cavity wall. The mechanical tapper is operated on a low duty cycle synchronised with the signal detection duty cycle. An acoustic provocation can be supplied with an ultrasonic source operating at a frequency known to be annoying to the insects or small animals. For example, high frequency signals are known to cause agitation in small animals. Chemical provocation can be obtained by periodically dispensing a small quantity of pesticide by activating a solenoid to open a door to a storage chamber. As shown in FIG. 7 , one side of the bait dispenser 5 may have attractant bait and the other side may have a chemical provocant that is released under control of the solenoid. The bait station may be powered by standard battery packs. The active current drain is in the order of 150 mA at 6 volts. Hence, four standard AA batteries of 150 mAHr is sufficient to the power the antennas for 1000 hours or approximately forty (40) days in standby mode. The battery life may be slightly less with the addition of the provocation means. In an alternate form, other types of rechargeable batteries may be used. Solar cells may be provided as auxiliary power or substitute for the battery packs. Any number of configurations are possible as it would be readily apparent to a person skilled in the art. One advantage of the present invention is the bait station can be monitored remotely to evaluate the activities of pests and insects. The number of insects and activity habits can be monitored and evaluated over a period of time. The invention has been described with reference to an exemplary embodiment. However, it should be noted that other embodiments are envisaged within the spirit and scope of the invention.

1a

BACKGROUND OF THE INVENTION This invention relates to controlled administration of chemodenervating agents, e.g., botulinum toxin-derived pharmaceuticals, useful in attenuating neural stimulation and spasmotic activity of muscle. More particularly, the invention relates to a method of standardizing denervating pharmaceuticals and novel dosage forms based thereon which permit medically safe administration in the management of a variety of diseased states and injuries characterized by involuntary muscle spasm or hyperactivation. The invention also relates to novel methods of administering chemodenervating agents in a controlled and reproducible manner so as to confine their effect to a given region of muscle mass while minimizing paresis in adjacent muscle tissue. Pharmaceutical grade preparations from the toxin produced by Clostridium botulinum have been available for many years from Dr. Allan Scott and the Kettlewell Ophthamology Institute of San Francisco, Calif., and now is sold commercially by Allergan Pharmaceuticals, Inc. Many other materials toxic to neuromuscular transmission are known, such as tetanus toxin and various subtypes of botulinum toxin. Botulinum toxin preparations recently have been approved for the treatment of blepharospasm and strabismus, and clinical trials are underway on the treatment of spasmodic torticollis. Dykstra et al have proposed in U.S. Pat. No. 4,932,936 that botulinum toxin can be used in the treatment of spasmodic sphincter muscle which leads to urinary incontinence ("neurogenic bladder") characteristic of some forms of cancer. A survey of the literature provides evidence for the potential use of chemodenervating agents such as botulinum toxin in the treatment of other significant spasmodic diseases including jaw dystonias, occupational dystonias, corneal ulceration (protective ptosis), spasmodic dysphonia, and various forms of facial dyskinesis including Meige syndrome, hemifacial spasm, aberrant regeneration of facial nerves, and apraxia of eyelid opening. Treatment of these diseases involves injection of a chemodenervating agent, currently a botulinum preparation, directly into the muscle, using, for example, a fine gage teflon-coated needle under electromyographic control to aid the physician in locating the intended intramuscular locus of the injection. The pure active toxin is believed to be the single most toxic material known. A sufficient dose of the toxin acts on striated muscle to block release of the acetylcholine neurotransmitter from the presynaptic membrane resulting in varying degrees of effective denervation of the muscle in regions contacted by the toxin. This results in an increase in post-synaptic acetylcholinesterase activity and an increase in the population of acetylcholiee receptors, effects which occur as a characteristic physiological response to denervation. After a period of days, the axon terminals develop sprouting, and over a period of several months, collateral motor axons establish new neuromuscular connections with the muscle fiber. As neuromuscular junctions are regenerated, full function of the muscle returns along with the spasmodic contractions or hyperstimulation symptomatic of the disease. With the exception of the emerging spasmodic torticollis therapy, development of the therapeutic uses of botulinum toxin preparations has been limited to small muscles which may be treated with lower doses and have limited risk of toxin spread. Development of the therapies has proceeded empirically using low doses without theoretical basis or clinical data predictive of the distribution of the toxin in vivo. Currently, toxin preparations are quantified by measuring the LD 50 in white mice. LD 50 in white mouse equals one international unit or I.U. The treatment of blepharospasm with botulinum toxin as disclosed by Borodic et al in Plastic and Reconstructive Surgery. (March, 1989) is illustrative of a protocol for use of the toxin. Generally, for bilateral blepharospasm, a starting dose totalling 10 to 20 IU is injected at 4 to 6 sites in the upper and lower eyelid of each eye spaced laterally from the midline of the lid and close to the lash base of the upper lid. Injections above the brow are given only if significant involuntary movements are recurring in this region. If the toxin is injected too close to the upper lid fold, diffusion through the orbital septum can weaken the levator palpebrial superioris muscle and induce ptosis. If the toxin is injected too medially in the lower lid, the naso-lacrimal pumping mechanism can be weakened excessively resulting in epiphora. With an appropriate dose, because the muscle is only partially weakened, enough strength and neural control remain so that a treated muscle still can perform its primary voluntary function. The degree of weakening from denervation can be "titrated" empirically for particular patients by altering the dose. SUMMARY OF THE INVENTION This invention provides a novel method of measuring the activity of neurotoxin derived chemodenervation pharmaceutical preparations, such as botulinum toxin-derived preparations. Exploitation of the method permits manufacture of the preparation in standardized dose forms of predictable clinical effect labeled to indicate the zone of denervation, activity that will be induced by a unit dose of the preparation when injected in vivo. Provision of such dosage forms and the teaching disclosed herein permits the physician to preselect appropriate dosage in advance of injection of the preparation and to chemodenervate a given volume of muscle mass while essentially confining diffusive spread of the toxin within that predetermined volume. Thus, practice of the method of the invention permits the physician to avoid or minimize the complications of therapies involving such agents, i.e., to avoid inducing unwanted dysphagia or partial paralysis in muscles adjacent the site of injection which may be directly or indirectly life threatening, incapacitating, or disfiguring. Practice of the invention permits more exacting application of the toxin and facilitates its use in large muscle groups of the limbs and trunk. The foregoing is accomplished by determining experimentally within a muscle of an experimental animal the spatial extent of inhibition of acetylcholine release about a site of injection of a unit quantity of the preparation. The determination may be made in several ways. One can determine the extent of inhibition of muscle stimulation in regions spaced apart from the site of injection by electrophysiologic testing, for example, electromyography, e.g., single fiber electromyography. This method of determining the spatial extent of inhibition of acetylcholine release is most direct but also most cumbersome. More easily conducted indirect measurements currently are preferred. These techniques involve postmortem sectioning of muscle at regions spaced apart from the site of injection and determining the extent of denervation by indirect methods which take advantage of the known physiologic effects of neurotoxin based chemodenervation phenomena. For example, one may employ suitably labeled monoclonal antibody or polyclonal antisera raised against an epitope or epitopes of the toxin preparation which remain exposed or becomes exposed upon binding of the toxin to the motor end plate, against acetylcholine receptors (which increase significantly in response to denervation), or against acetylcholinesterase (which also increases upon denervation). The currently preferred method is to determine the local concentration of acetylcholinesterase in regions of the muscle spaced apart from the site of injection by colorimetric estimation of enzyme activity. Practice of the invention permits manufacture of novel dosage forms which are safer to administer, and permits expansion of chemodenervation therapies to the management of diseased states in larger muscles and muscle groups while reducing the risk of side effects. Thus, in another aspect, the invention comprises a novel article of manufacture comprising a package containing a neurotoxin-derived pharmaceutical for chemically inducing in vivo. upon injection of a unit dose of the pharmaceutical into a point in a muscle, at least partial denervation in a predetermined volume of muscle tissue spaced about the injection point. Printed on the label for the package or as an insert is information indicative of the volume of in vivo activity of a unit dose of the pharmaceutical. The physician thus can purchase, for example, a pharmaceutical preparation known in advance to induce partial chemodenervation within, for example, 3 mm, 10 mm, or 30 mm about the site of injection. With knowledge of the gross or microscopic anatomy of the muscle or muscle group involved, the physican can chemically denervate reproducibly a preselected volume of muscle tissue without inducing significant paresis in muscle tissue outside the preselected volume. This may be accomplished by selecting a particular unit dosage form and injecting a unit dose in one, or more typically in a number of spaced apart locations within he muscle to induce denervation within the preselected volume. The physician therefore can more clearly estimate the depth and area of toxin spread. The exact form of the dose of a pharmaceutical standarized in accordance with the invention can vary. Thus, the pharmaceutial may be lyophilized and in condition to be reconstituted before use, or may comprise a stabilized protein solution. While the invention is unlimited with respect to the nature of the neurotoxin which is standardized, it preferably is practiced on biologicals produced by prokaryotes such as those from the genus Clostridium. The currently most preferred neurotoxin is a botulinum toxin-derived pharmaceutical, most preferably a preparation derived from botulinum toxin type A. It may however take the form of any of the known types of botulinum toxin (A through G) or various engineered proteins which retain the native form's ability to block acetylcholine release. Knowledge of the in vivo biodistribution of chemodenervating agents gained by the practice of the invention permits very significant expansion of the use of these materials in the management of human disease. The agents may be used safely either for their direct or indirect effects. One example of their indirect effects involves use of such materials in facial cosmetic applications. The administration of an appropriate dose of, for example, botulinum toxin, to attenuate tone of muscles about the eyes and forehead can in many cases remove wrinkles characteric of aging in skin overlying the muscle while inducing only mild, often acceptable muscle weakness. Such chemodenervating agents also may be used to induce cosmetic improvement in hemifacial paralysis by intentionally inducing partial paralysis in the contralateral side of the face thereby to improve bilateral facial symmetry. The materials may be injected at points spaced asymetrically about the spine within paraspinal muscles to alter muscular support for the spine in juveniles to prevent or ameliorate the development of scoliosis. Injection of low doses of the agents into muscles activating the jaw can retard tooth wear caused by involuntary or unconscious clenching of the teeth. Examples of direct effects are the treatment of unwanted involuntary pathologic muscle stimulation, i.e., spasm, rigidity, or hyperstimulation, by direct injection throughout, or in the area of innervation of, the affected muscle or muscles. Thus, diseases involving muscle spasticity in general can be treated, typically without regard for its cause. The drug may be used to alleviate overstimulation, rigidity, or spasticity in muscle or muscle groups caused by stroke, cerebral palsey, multiple sclerosis, unilateral or bilateral parkinsonism, and other diseases characterized by spasmodic or continuous muscle hyperstimulation. Accordingly, it is an object of the invention to provide a novel method of standardizing chemodenervating neurotoxin-derived pharmaceuticals such as botulinum-derived pharmaceuticals. Another object is to standardize botulinum toxin preparations with respect to their zone of denervation when injected in vivo. Another object is to provide novel dosage forms of such agents. Yet another object is to provide novel therapies for muscle spasticity and/or hyperactivation heretofore untreatable or treatable only imperfectly with systemic drugs or surgery. BRIEF DESCRIPTION OF THE DRAWINGS Other objects and features of the invention will be apparent from the description and claims which follow and from the drawing wherein the sole figure is a bar graph illustrating measurement of the zone of chemodenervation of two botulinum toxin preparations. DESCRIPTION The invention may be practiced on any substance capable upon injection of interrupting nerve impulse transmission across the neuromuscular junction. While many such neurotoxins are known, the currently most promising reagents of this type are the family of toxins derived from Clostridium botulinum, and the most preferred is pharmaceutical grade botulinum toxin Type A available commercially from Allergan Pharmaceuticals, Inc. under the tradename OCULINUM. However, it should be stressed at the outset that it is a fundamental advantage and feature of the invention that it can be applied to any injectable substance which interrupts neuromuscular transmission at the synapse, and that other materials of this type when and if developed to pharmaceutical grade could be used in the novel therapies. Thus, it is contemplated that other materials, protein subunits, recombinantly produced materials, and other various novel types of pharmaceutical preparations can be used in the practice of the invention to advantage. However the work forming the basis of the invention was conducted using the commercially available botulinum toxin-based material identified above, and the remainder of the discussion will be limited to this material, hereinafter referred to simply as "toxin". Injection of a sublethal dose of a toxin into muscle deposits a bolus of the material intramuscularly which diffuses outwardly to a distance that is a complex and currently unknown function of, inter alia, the identity and amount of diluent if any injected with the toxin, the mass of the toxin, the population of presynaptic receptors about the site of injection, and the then current physiological condition of the patient. Diffusion, driven presumably by the concentration gradient, slows as active toxin binds to receptors on the. presynaptic membrane. Some portion of the toxin is swept away by the vascular system and distributed systemically. Some other portion may be proteolytically degraded before binding. Doses far smaller than the LD 50 for man (believed to be on the order of 2 μg) can paralyze completely, or partially or lightly denervate a muscle volume, depending on dose. The therapetic effects are achieved at dosage levels in the range between a few I.U. to 500 to 1000 I.U., preferably no more than 500 I.U., and most preferably no more than 300 I.U., administered as a plurality of injections about a muscle or muscle group. Injection of a therapeutic dose results in destruction of a subset of the neuromuscular junctions innervating the muscle but leaves others in a functional state. It has been hypothesized that a threshold quantity of the toxin must bind to a particular axon before that axon becomes irreversibly poisoned and the denervation-renervation cycle is initiated. Motor end plates which receive a dose below the threshold presumably recover and participate together with unaffected axons in continued innervation of the muscle. Support for this model of drug action comes from the observations that: transient low level retardation of muscle stimulation can be detected in some cases in muscles remote from the site of injection; an animal poisoned intraperitoneally with the toxin upon autopsy shows no histological signs of denervation, and; there is a gradient of denervation about the site of injection. Another factor affecting dose response is the existence of innervation zones within muscles, i.e., there are differences in the microanatomical distribution of neuromuscular junctions within muscles. A literature search suggests that little is known about muscle innervation patterns. However, it is clear that some muscles are denervated more or less uniformly throughout their mass whereas others have a zone of innervation in one region. Thus, particularly in large muscles, the locus of injection within the muscle can influence the physiological response. The extent of denervation of a muscle can be determined postmortem by sectioning the muscle and staining for acetylcholinesterase activity using the method of Karnovsky (See Woolf and Coers, The Innervation of Muscle. Charles Thomas Pub, Springfield, Ill., 1959). As disclosed below, excision of human muscle previously treated with the toxin, and postmortem sectioning of rabbit muscle about a site of toxin injection, exhibit a gradient of denervation akin to that disclosed by Duchen in mice (See J. Neurol. Neurosurg. 1970:33:40-54; J. Physiol. (Lond) 1969; 204:17-18). In accordance with the invention, the extent of spread of a given dose of a chemodenervating agent is used as a measure of the activity of the preparation, and is used to quantify an appropriate dose for injection into a muscle or muscle group. This permits the physician to confine the action of the toxin to a predetermined volume of muscle and to prevent or minimize the spread of the toxin into adjacent muscle tissue. For example, a given dose of a given preparation is injected into the muscle of an experimental animal. After three to five weeks, the animal is sacrificed, and in order to assess toxin spread of the injected dose, sections are taken about the site of injection, for example, 3, 10, 15, 30, 45, and 60 mm from the site. Each of the sections is stained to determine, for example, acetylcholinesterase activity. This permits visualization of the zone of effective denervation which can be determined rather precisely. Alternatively, the muscle may be sectioned through the point of injection across the denervated field and stained so that the gradient can be observed readily. Correlation of these data between, for example, small rodents and simians by direct observation, or between the experimental animals and surgically excised human muscle, backed by clinical experience, provide precise information on the zone and extent of denervation a given dose of toxin will induce when injected at a given site in a human. Determination of the extent and zone of inhibition of acetylcholine release can be measured by various techniques known to those skilled in the art in addition to acetylcholinesterase staining, including single fiber electromyography (See, for example, Sanders et al, Botulinum Toxin for Blephorospasm. Single Fiber EMG Studies. Neurology, 85; 35:271-272) and by using labeled binding proteins such as polyclonal or monoclonal antibodies labeled with, for example, fluorescein of other fluorescent moiety, colloidal metallic particles, or other remotely detectable substance. Antibodies can be produced, using known techniques, to acetylcholine receptors or to acetylcholinesterase, both of which can serve as a marker for effective denervation, or to epitopes which are newly exposed, or which remain after binding of the toxin to the receptor on the presynaptic motor end plate. Other stains may be used such as hematoxylin, eosin, and masson trichrome. Any of these techniques and others that can be devised may be used to determine the extent of diffusion and effective denervation of a given dose of a chemodenervating agent within the muscle of an experimental animal. Use of the technique enables chemodenervating agents to be prepared in various dosage forms and provides nomograms which enable the physician to inject the agents for therapeutic purposes in humans responsibly while eliminating or minimizing side effects caused by unwanted toxin spread beyond the intended denervation zone. Some degree of paresis and muscle weakening beyond the intended locus of denervating action may nevertheless occur. However, the physician may use the techniques and chemodenervating pharmaceuticals standardized as herein disclosed to tailor dose to the selected point or points of injection based on his diagnosis determining the affected muscles. The denervating effect therefore can be confined essentially to a given muscle or muscle groups despite the observation that botulinum toxin can spread beyond intervening facial planes and bony structures. Data obtained using the process of the invention to date indicate clearly that the size of the field of action of therapeutic injections of chemodenervating agents is dose dependent. Furthermore, several of the observed complications in established clinical protocols have been correlated to spread of the toxin beyond the intended field of action by retrospective and prospective study of the anatomic injection sites and doses. The sole figure of the drawing is a graph disclosing data representative of the type that can be generating using the process of the invention. Longissimus dorsi muscle of groups of six New Zealand white rabbits were studied to assess differences in acetylcholinesterase staining activity at varying distances from the site of injection of two separate doses of botulinum toxin. The first dose contained four to six I.U. as determined by dilution from a 100 I.U. vial of the commercial preparation; the second contained 0.2 to 0.4 I.U. The toxin was reconstituted at 1.25 I.U. per 0.1 ml physiological saline. The point of injection was marked with a tattoo. The injections were made 5 to 8 mm deep directly into the muscle. A control animal was injected with the saline diluent. After five weeks, the animals were sacrificed, and sections of the muscle were taken 15, 30, and 45 mm caudel from the sites of injections transverse to the spine and in a direction parallel to the spine on the contralateral side. Acetylcholinesterase slide staining was conducted by placing muscle specimens in Baker's solution (10% formal-calcium), which the were refrigerated, and after 24 hours, placed in 0.88 gum sucrose for 2 to 3 hours. the muscle then was sectioned into 10 micrometer sections in a cryostat at a -20° C. and placed on gelatin-coated slides. Acetylcholinesterase activity was demonstrated by Karnovsky's method, and the slides were incubated for 90 minutes at 37° C., washed in distilled water, counterstained with fast green, dehydrated rapidly, and mounted. At the site of injection, diffuse acetylcholinesterase staining was seen over essentially all muscle fibers. For the larger dose, (2 to 3 I.U./kg) the muscle histology was essentially identical at 15 mm. At 30 mms, a decrease in acetylcholinesterase enzymatic activity was indicated by a reduction in color intensity, but very significant muscle denervation was still apparent. At 45 mm, a very significant reduction in enzyme activity was noted. For the smaller dose (0.1 to 0.2 I.U./kg) immediately about the site of injection enzyme activity was similar to the larger dose. However, at 15 mm from the site of injection, denervation was markedly diminished, and at 30 mm and 45 mm, enzyme activity was barely above levels observed in control specimens. Contralateral longissimus dorsi biopsy specimens revealed staining intensities similar to those observed in the specimens discussed above, illustrating that toxin diffuses unhindered through facial planes and about bone. These results demonstrate the feasibility of the standardization process of the invention. That such results can be used to improve the clinical efficacy of botulinum preparations was demonstrated in the clinic as follows. Retrospective reviews were conducted from the records of patients with adult onset idiopathic spasmotic torticollis who had been given botulinum A toxin for a period of two to thirty-eight months (average 1.1 years) and who had experienced the complications of dysphagia (difficulty in swallowing caused by paresis). In these patients, the toxin had been reconstituted in normal saline (≃100 I.U./ml) without preservative and injected with a 25 or 27 gauge needle. Patients had been evaluated bi-weekly or immediately for evidence of dysphagia. A single treatment consisted of one or more injections to the sternomastoid muscle or to the posterior cervical muscles, or both. The muscles injected had been determined to be dystonic based on palpation, hypertrophy, involuntary spasms, and posture deformity. Each of the 49 injections to the cervical musculature of 26 patients was characterized with respect to dose and injection site. The injections that did not result in dysphagia were then compared with those that did. The data from this retrospective analysis indicated a potential cause-effect relationship between the dysphagia and sternomastoid dosage. Analysis of the data indicated that each patient who experienced dysphagia noted the onset of symptoms within 20 days of the injection and reported a duration of from six days to four weeks. There was no significant difference between total dosage given patients who experienced dysphagia and those who did not. However, if the dose given to individual muscles was evaluated, a significant difference in the dose administered to the sternomastoid muscle was apparent. More specificially, every patient who had experienced dysphagia had had 150 I.U. to 175 I.U. injected into the sternomastoid muscle. In addition to numeric analysis of dose, every patient who experienced dysphagia had been injected in their sternomastoid muscle, and the complication did not occur if the posterior cervical muscle group was alone injected. Thereafter, 24 patients were enrolled for a prospective study and were asked to report to the investigator promptly should dysphagia occur. Each patient was contacted within four weeks of injection and specifically questioned to assess whether post-injection dysphagia had occurred. Each of these patients were given a dose not greater than 100 I.U. in the sternomastoid muscle at three, four, or five injection points, typically five, of 20 to 35 I.U. per injection site. In addition, eight additional injections were given to six patients who initially experienced dysphagia yet benefited substantially from the previous treatment. Patients from this group were injected after a period of at least five months from the previous injection with a sternomastoid dose of 100 I.U., again in 3 to 5 points along the length of the muscle. None of the next 31 injections in the 24 patients were followed by dysphagia. Furthermore, the six patients previously experiencing dysphagia who received eight injections under the new treatment protocol showed no reoccurrence of dysphagia after 20 weeks follow-up. These data indicate that injection of 100 to 175 I.U. (2-3 I.U./kg) into the sternomastoid can result in diffusion of the botulinum preparation into deeper muscles of the throat resulting in dysphagia manifest by difficulties in speaking, swallowing, or breathing. In contrast, smaller doses of 20 to 30 I.U. spaced 5-15 mms apart, limiting the total does to less than about 100 I.U. (<2 I.U./kg) in the sternomastoid resulted in no deep muscle involvement causing dysphagia. In these patients the sternomastoid is about 30 mm from the pharanx. These data are supported further by the histological observation of strips of obicularis oculi muscle (normally discarded) excised from patients undergoing ptosis surgery who had been treated previously with botulinum A for involuntary blepherospasm, and control specimens of obicularis oculi excised from patients with involutional ptosis who had never been injected with botulinum toxin. The test specimens were obtained four weeks to four months after the last botulinum toxin injection and each was treated to assess denervation as disclosed above. Each toxin treated muscle specimen exhibited extensive spread of acetylcholinesterase activity over the individual muscle fibers. The diffuse pattern of staining, which was associated with muscle fiber atrophy, made identification of discrete neuromuscular junctions difficult. In contrast, each of the four control specimens showed discrete areas of staining on the muscle fiber surface corresponding to acetylcholinesterase activity and position of neuromuscular junctions of the muscle fiber. These and other observations from the clinical treatment of blepharospasm indicate that 20 I.U. botulinum toxin (0.2-0.4 I.U./kg) will spread less than about 30 cm in human obicularis oculi. In accordance with the invention the toxin may be prepared in dosage form in conventional biologic standardizations such as LD 50 but most importantly in terms of a unit dose of the toxin's spread capability. This involves nomagram preparation as outlined above and labeling the pharmaceutical agent with the information to provide the physician with the capability of placing injection sites at preselected intervals on the muscle selectively to denervate the muscle and to limit toxin spread in contiguous muscles. This permits expansion of use of the preparations into procedures such as those described below. INHIBITION OF TOOTH WEAR The involuntary grinding of teetch characteristic of true bruxism is caused by involuntary contractions of the masseter, temporalis and pterygoid muscles. The masseter and temporalis usually are targeted as the muscles which will undergo chemodenervation. They are injected so as to limit the penetration of the toxin to the volume and body of the muscles. Diffusion should be limited to a distance of no more than 25 to 35 mms. A unit dose injection is given at the surface of each of these muscles at multiple points percutaneously or permucosally. Of course, appropriate dental evaluation to assess the degree of damage or potential damage to the teeth should be conducted prior to application of the toxin. The treatment is repeated periodically, e.g., at three to five month intervals as needed to inhibit jaw clenching to protect the teeth, and to relieve the pain syndrome, if any. COSMETIC WRINKLE REDUCTION Facial expression lines such as the transverse forehead lines or the nasolabial fold are created by attachments of projections of facial muscles into the dermis. Contraction of facial muscles generally is well known to produce the various characteristic forms of facial expressions such as smiling, grimacing, etc. In addition, exaggeration of facial lines also is associated with the aging process. The general principle of the application of the toxin is to limit the tonic contractile state of facial muscles so as to reduce muscle tone and to improve or change the quality and characteristics of facial expression. The transverse forehead lines may be reduced in intensity by injecting a quantity of toxin with a diffusion field of approximately 5 to 10 mms in four injection sites at the superior border of the forehead and at a point approximately 15 mms superior to the brow. This is done symmetrically on both sides of the forehead. The glabellar lines (the frowning lines in the mid position of the forehead) may be targeted by treated the glabellar muscles with a toxin quantity producing a field of denervation of 5 to 10 mms The toxin is injected 15 mms. above the brow line in the mid position of the forehead. The nasal labial fold lines can be diminished in their intensity by treating the zygomatic major and minor muscles which emanate from the zygomatic arch and extend diagonally to the position of the nasal labial fold. An injection of toxin diffusing a distance of 5 to 10 mms over the superior border of these muscles will diminish this line effectively. Furthermore, the position of the lips can be controlled by injecting the zygomatic major and minor muscles. The protrusion of the upper lip can be reduced and even inverted by injection of these muscles. In addition, the protrusion of the lower lip can be reduced by injecting the mentalis muscle at doses producing a denervating field of 5 to 10 mms at the level of the chin approximately 15 mms inferior to the lower lips at a point of approximately 5 mms from the midline. STROKE AND CEREBRO-SPINAL INJURY Cerebrovascular injuries (stroke and cerebro-spinal injury) can cause spasticity and contractions as a result of paralysis and spasticity. Although the toxin produces a paralysis, it can be useful in reducing muscle mass and in helping spasticity. Symptomatic spasticity can result in chronic involuntary movements as well as difficulties with contracted postures or contractions of the limbs. The application of the drug to these spastic states involves knowledge of innervation zones of limb muscles, (See, e.g., Woolf et al, supra). The muscle which is involved in the abnormal posture or abnormal movement can be identified with an electromyographic needle. Such muscles can also be identified as causing the posture deformities based on experience and an understanding of the muscle's contractile states on the limb position and movement capabilities. These muscles are impaled with a needle at a site close to the innervation zone. In certain situations, it may be necessary to stimulate the muscle with a stimulating current through a teflon coated electromyographic needle to insure the correct placement of the injections. The toxin is injected at a dose level appropriate to create a field of denervation encompassing the innervation zone of the muscle or the entire muscle. Multiple injections over long muscles may be necessary to isolate the effect over that muscle. CEREBRAL PALSY Cerebral palsy results from various forms of brain damage related to anoxia or vascular insufficiency, usually at the time of birth. The destruction of the central cortex of the central motor system results in involuntary movement spasticity, abnormal posturing, and unwanted contractures of muscles. Physical therapy and occassionally antispasmodic drugs are used to treat cerebral palsy. In situations where spasticity is involved with pain, deformity, involuntary movements, or limitations in functional capabilities of a patient, use of the toxin may be indicated. Application involves targeting muscle groups vital to the patient's disability such as muscles which produce limb deformities or impairments in the volitional movements, or in situations where contractures seem to be developing into abnormal postures. The dosage for treatment of this disease will involve targeting these muscles and using a formulation similar to that used to treat cerebrovascular disease. The prototype for large muscle applications is spasmotic torticollis. The targeted muscles is injected with a dose sufficient to encompass the innervation zone of the muscle. MULTIPLE SCLEROSIS Multiple sclerosis is a disease of white matter of the central nervous system. It involves a demyelination process which leads to impairment of the cortical spinal track and associative tracks in the brain stem. This leads to spinal damage and resultant spasticity. Spasticity in multiple sclerosis can be debilitating because of involuntary movement, contracture, posture deformities, and in certain situations, pain. Use of the toxin is directed and targeted at indications which relieve these particular afflictions relative to the management of the disease. Again, the toxin is targeted at muscles determined by the physician, neurologist, podiatrist or orthopedic surgeon that appear to be hyperactive. The muscles are injected with a quantity sufficient to encompass volumetrically the muscle or its innervation zone, or both. A working knowledge of muscle anatomy, innervation, and functional anatomy will be needed by the practitioner to achieve optimum results. PARKINSON'S DISEASE Parkinson's disease is characterized by three basic defects: akinesia (lack of movement); tremor (involuntary movement); and rigidity (increase muscle tone in muscle groups). The toxin can be used to improve the degree of tremor and rigidity present in Parkinson's disease although it probably will be contraindicated in akinesia. In certain situations in Parkinson's disease severe dystonias develop in the patient's limbs. In these situations, the involuntary movements are exaggerated, spastic, and often painful. Toxin is injected into the muscle in a dose sufficient to encompass the volume of the muscle or its innervation zone or both. It is done with a stimulating electrode needle to an EMG machine or in conjunction with EMG machine to insure the correct placement of the needle in the muscle. The toxin is given in multiple injection points for large muscles in order to insure an adequate percentage of the innervation zone is encompassed in the injection formulation. The toxin injections must be repeated every three to six months to sustain the desired clinical effect. Total dose administered to initiate a given cycle of denervation--reinnervation should in all cases be far below the LD 50 for the patient. The invention may be embodied in other specific forms without departing from the spirit and essential characteristics thereof. Other embodiments are within the following claims.

1a

FIELD OF THE INVENTION [0001] The present invention relates to fecal incontinence assistance devices. More specifically, it relates to a fecal incontinence assistance device with a time of use limitation function. BACKGROUND OF THE INVENTION [0002] Many personal medical devices are designed to be used for a limited amount of time or a limited number of occurrences of a particular event. In a supervised setting such as a hospital or nursing home, requiring caregivers to follow an established procedure is the normal method to guaranty that those devices are not used beyond their expiration. In that case, the hospital or nursing home must rely on written or computerized care logs to verify that such devices are changed according to their required schedules. In the case of unsupervised care, where patients use the devices themselves, there is no way to ensure that the devices are changed according to their required schedules. SUMMARY OF THE INVENTION [0003] The present invention provides a reusable medical device comprising a disposable portion and a processor. The disposable portion comprises a probe capable of insertion into an opening of the human body for detecting a condition within the body and a memory associated with the probe for storing a value representing an amount of time that the probe has been in use. The processor is electrically connected to the disposable portion and reads and updates the value stored within the memory. The processor further alerts the human or a caretaker of the presence of the condition. BRIEF DESCRIPTION OF THE DRAWINGS [0004] FIG. 1 is a perspective view of a disposable catheter according to an embodiment of the of the present invention; [0005] FIG. 2 is a perspective view of FIG. 1 having a fecal guard and a filter tip installed upon the probe according to an embodiment of the of the present invention; [0006] FIG. 3 is a section view of a catheter probe according to an embodiment of the of the present invention; [0007] FIG. 4 is a perspective view of a memory associated with a disposable catheter according to an embodiment of the of the present invention; [0008] FIG. 5 is a perspective view of a memory encapsulated in epoxy associated with a disposable catheter according to an embodiment of the of the present invention; [0009] FIG. 6 is a front perspective view of a processor according to an embodiment of the of the present invention; [0010] FIG. 7A is a rear perspective view of a processor without a battery door attached according to an embodiment of the of the present invention; [0011] FIG. 7B is a rear perspective view of a processor with a battery door attached according to an embodiment of the of the present invention; [0012] FIG. 8 is a schematic view of a disposable catheter and processor according to an embodiment of the of the present invention; [0013] FIGS. 9A, 9B , and 9 C are perspective views of fecal guards according to an embodiment of the of the present invention; and [0014] FIG. 10 is a perspective view of a filter tip according to an embodiment of the present invention. DESCRIPTION OF THE PREFERRED EMBODIMENT [0015] While the invention is susceptible of embodiment in many different forms, there is described in detail preferred embodiments of the invention. It is to be understood that the present disclosure is to be considered only as an example of the principles of the invention. This disclosure is not intended to limit the broad aspect of the invention to the illustrated embodiments. The scope of protection should only be limited by the claims. [0016] Disclosed is a device for insertion into a human body for blocking an opening of the human body and alerting the person, or an individual caring for the person, when a quantity of effluent has accumulated near the device within the opening. The device is further capable of alerting the person or a caretaker to remove the device to allow the effluent to exit the body. Furthermore, the device has the capability to alert the person when the device should be replaced by the user or caretaker because it has reached a limit beyond which it may no longer be used safely, such that risk of infection or malfunction is minimized. [0017] In one particular application the device may be used as a fecal incontinence monitor. The fecal incontinence monitor may be inserted in the rectum to block the accidental passage of feces. The device further detects when a quantity of feces has accumulated in the rectum near the monitor to notify the patient or caregiver when fecal matter is present so that it may be expelled at the next opportunity. [0018] In this regard and referring to FIGS. 1, 2 , & 3 , the device comprises a silicone catheter tube 10 having a proximal end 12 and a distal end 14 . Near the distal end 14 of the catheter tube 10 is an inflatable balloon 16 . Beyond the inflatable balloon 16 is a probe 18 . The probe 18 is made from a rigid material and comprises a hollow cylinder having two annular exterior barbed ribs 24 , 26 and two journals 20 , 22 . The silicone tube 10 is placed onto the probe 18 by sliding the tube 10 over barbed rib 26 . The probe 18 further defines two metal electrical contacts 25 molded into the probe 18 such that the contacts 25 protrude through the probe 18 on opposite sides, extend into the interior of the probe 18 and through an opening at an end of the probe 18 . The contacts 25 are attached to electrically conductive wire 34 located within the catheter tube 10 . As a result, if a potential difference is applied to the contacts 25 , when an electrically conductive fluid comes in contact the electrical contacts 25 a complete circuit is accomplished through the fluid, and in this manner comprise a moisture detector. [0019] The balloon 16 is attached to and is in fluid communication with a hollow air supply tube 28 within the catheter tube 10 . In FIG. 1 , the balloon 16 is shown in its inflated state. When in its uninflated state, the balloon 16 has an outer diameter generally no greater than that of the catheter tube 10 . [0020] The hollow air supply tube 28 is further in fluid communication with a check valve 30 . The check valve 30 is biased to a normally closed state wherein air within the air supply tube 28 is trapped within the tube 28 . Furthermore, the balloon 16 is designed to allow air to permeate through the balloon 16 such that an inflated balloon will slowly deflate. In this manner, decubitus ulcers caused by the pressure of the balloon 16 cutting off blood supply to a portion of the rectum are avoided. However, this does require the user to occasionally reinflate the balloon 16 , as described below. [0021] Referring to FIGS. 1 and 2 , a small serial memory chip 36 is disposed near the proximal end 12 of the tube 10 . The memory 36 is further attached to electrical wire 38 that leads to a RJ-45 connector. Referring to FIG. 3 , the memory 36 and the electrical wires 38 are soldered to a printed circuit board and encapsulated in a nonconductive epoxy coating 39 ( FIG. 4 ). The printed circuit board upon which the memory 36 is mounted is preferably no more than generally 0.125 inch by 0.562 inch and more preferably smaller than such dimensions. [0022] Referring to FIGS. 6, 7A , and 7 B, the RJ-45 connector 40 is attached to a controller 50 . The controller 50 comprises a small plastic box that may be attached to a user's belt or pant waistline by means of a clip 52 and further comprises a modular port 54 for insertion of and electrical connection with the RJ-45 connector 40 . The controller 50 further comprises one green light emitting diode (“LED”) 58 and one red LED 56 that notify the user of the status of the electrical contacts 25 , memory 36 and the controller 50 . A switch 59 is provided so that the user may turn the controller on or off. A switch 55 is also provided so that the user may switch between vibrate and beep mode. Referring to FIG. 8 , the controller 50 further comprises a microprocessor 60 electrically connected to the memory 36 and the electrical contacts 25 . The microprocessor 60 is preferably a CY8C26233-24PVI made by the Cypress Microsystems Corp. of Bothell, Wash. The serial EEPROM is preferably an AT93C46 made by the Atmel Corp. of San Jose, Calif. During operation, the microprocessor 60 occasionally lights the green LED 58 to let the user know that the controller 50 is operating properly. When a low battery condition is present, the microprocessor 60 occasionally lights the red LED 56 to let the user know that the battery (not shown) is low and should be replaced soon. [0023] When the presence of fecal matter near the probe 18 is indicated by electric current traveling between the metal contacts, the microprocessor 60 causes a vibrator motor 64 to operate if the controller is in vibration mode, or a speaker 62 to sound an audible tone if the controller is in beep mode, to notify the user that he/she should remove the catheter at the next opportunity to expel accumulated feces. To acknowledge and end the alert, the user presses the switch 59 . [0024] Referring to FIGS. 2, 9A , 9 B, and 9 C, in order to control how fecal matter reaches to the contacts, a fecal guard 66 is placed over the probe 18 . The fecal guard 66 is maintained in position over the probe 18 by sliding a fecal guard 66 onto the probe 18 over the rigid, annular rib 24 and placing it over the journals 20 , 22 . The fecal guards 66 are generally cylindrical in shape with tapered ends 68 . In a central region thereof, the fecal guards 66 comprise cutout portions 70 which may vary in size. By varying the size of the cutout portions 70 , the ability of feces of different consistency to effectively reach the moisture detector can be varied. [0025] Furthermore, referring to FIG. 9 , a filter tip 72 is resiliently installed over the barbed rib 24 and held in place by tension and friction. The filter tip also secures the fecal guard 66 to the probe 18 . Filter tip 72 has a tip 74 in the general shape of a paraboloid of revolution and has a hollow, cylindrical body 76 . [0026] Upon initial communication, the microprocessor 60 functions by polling the memory 36 to determine the present numeric value stored therein. New catheters are provided to the user with the numeric value set to 0. The microprocessor 60 then increments the value of the memory 36 at set time intervals. In this manner, by reading and incrementing the memory 36 , the microprocessor 60 can identify how long the catheter 10 has been in use. The microprocessor 60 can further monitor the memory 36 to determine when the catheter has reached a point beyond which it is no longer safe to use. At such point, the microprocessor 60 can cease to function until a new catheter with a memory 36 value that has not reached an expiration point is attached, can continue to function during a grace period of operation before the microprocessor 60 discontinues operation or can continue indefinitely during the expired period. Preferably, the microprocessor 60 provides a notification to the user or the caretaker when the catheter has expired or will soon expire by lighting one or a combination of multiple LEDs and/or providing audible and/or tactile alerts. Upon expiration, the catheter 10 would be discarded and a new catheter with a new memory 36 set to zero would be implemented. [0027] In use, the catheter 10 is inserted into the rectum and a balloon 16 on the end of the catheter is inflated through the air supply tube 28 to hold the catheter 10 in place and to seal the rectum. The catheter 10 is inflated by attachment of the check valve 30 to a syringe which forces a measured quantity of air into the balloon 16 to inflate it. When fecal matter is detected, the controller 50 alerts the user by an audible or tactile alert. The user may then stop the alert by pressing the switch 59 , going to a restroom, deflating the balloon 16 by reinstalling the syringe and removing air, and removing the catheter 10 to allow the fecal matter to be expelled. [0028] Alternatively, rather than providing a memory 36 within the catheter 10 that is incremented, the present invention could implement a memory having a numeric serial number stored thereon. The microprocessor 60 would include a memory that associated a count with the serial number, the count being incremented at predetermined intervals. When the count reached a predetermined threshold, the catheter associated with the serial number would be marked as expired within the memory of the controller and would either cease to function until a new catheter with an unexpired serial number was attached, continue to function during a grace period of operation before the controller discontinues operation with the expired catheter or continue indefinitely during the expired period. Furthermore, the controller 50 would be able to track multiple serial numbers of catheters that have been used with the controller 50 , as well as store the periods of time such catheters were used with the controller 50 . [0029] In another alternative, the microcontroller could increment the count within the memory 36 not based on time, but instead based upon the occurrence of an event. For example, the memory 36 could be incremented every time an indication of moisture was detected by the moisture sensor 32 . In the event of a catheter that could be used only once, the memory would only need to store a value indicating whether the catheter had detected a single moisture event. [0030] Furthermore, it is envisioned that a radio frequency transmitter could be provided within the controller 50 to occasionally broadcast a signal to a receiving controller that allows a third party to remotely be notified of a signal from the moisture sensor or be notified of an expired or soon-to-expire condition of the catheter or any other information tracked by the controller. [0031] Furthermore, it is envisioned that the controller could monitor an air pressure within the air supply tube 28 to determine the inflation status of the balloon 16 . If the controller 50 detected that the balloon 16 was becoming deflated based upon a low air pressure reading, the controller 50 would alert the user or a caretaker so that appropriate action could be taken. It is also envisioned that an electrically operated air pump could also be provided within the controller to reinflate a balloon that, based on the air pressure sensor, was becoming deflated. [0032] Furthermore, while EEPROM memory is shown and described, any memory capable of holding a value and being incremented could be used instead. Obviously, while the connector is described as a RJ-45 connector, any connector having an appropriate number of conductors would work equally well. Additionally, while it is described that the memory is incremented until an expiration point is reached and new catheters are provided with memory having a value set equal to zero, it is readily apparent to one of ordinary skill in the art that memory could be provided with a value equal to a predetermined value and wherein that value is decremented to zero by the microprocessor. [0033] While the specific embodiments have been described, numerous modifications come to mind without significantly departing from the spirit of the invention, and the scope of protection should only limited by the scope of the accompanying claims.

1a

CROSS-REFERENCE TO RELATED APPLICATION This application claims the benefit of U.S. Provisional Patent Application No. 61/757,692, filed Jan. 28, 2013, entitled LACE FIXATION SYSTEM WITH LOW FRICTION GUIDES, the entirety of which is incorporated by reference for all purposes. SUMMARY Various lace fixation assemblies and systems beneficial to both manufacturers and users. In particular, the lace fixation assemblies and systems of the present disclosure may provide an easy to understand and easy to use means of adjusting and securing the closure of an article of footwear or other item. The lace fixation assemblies and systems of the present disclosure may further allow the use of small-diameter, low-friction lace material that does not require gripping by hand to secure or tighten. The lace fixation assemblies and systems of the present disclosure may further provide a convenient means to store excess lace after tightening while allowing quick and easy release and refastening of the fixation for secondary tension adjustment. The lace fixation assemblies and systems of the present disclosure may further be of a design and material such as plastic or other synthetic material that is economical to produce and to incorporate into existing manufacturing methods. For example, in a first aspect, a lacing system for tightening an article is disclosed. The lacing system may include or comprise a fixation member coupled to the article, the fixation member having at least one entry aperture and an exit aperture with a lumen extending therebetween, the fixation member also having a spool with a fixation post. In this example, the fixation member may be rigidly fastened to the article. The lumen may include or comprise of a passage, a cavity, a tube structure, or the like. Further, the spool may include or comprise of a flanged cylinder whereby an element may be wound around or to the post. Other embodiments are possible. The lacing system may further include or comprise a tension member having an intermediate portion slidably disposed within the lumen of the fixation member such that a proximal portion of the tension member is positioned on a proximal side of the fixation member and a distal portion of the tension member is positioned on a distal side of the fixation member and such that a length of the proximal portion and a length of the distal portion is adjustable via sliding of the tension member within the lumen. In this example, the tension member may include or comprise a lace or lacing that has a particular diameter. The tension member may generally be laced to the fixation member, and a length of the tension member protruding or exiting from the fixation member may be adjusted as desired. Other embodiments are possible. The lacing system may further include or comprise a plurality of guide members coupled to the article on the proximal side of the fixation member to guide the proximal portion of the tension member along the article to the fixation member. In this example, the tension member may generally be laced to each of the plurality of guide members. Other embodiments are possible. The lacing system may further include or comprise a tensioning component coupled to the distal portion of the tension member to effect sliding of the tension member within the lumen and thereby tighten the article by adjusting the length of the proximal portion of the tension member, and to maintain a tightness of the article by winding of the tension member about the fixation post, wherein the tensioning component is securable to the spool of the fixation member. In this example, the tension member together with other elements or features of the example lacing system may be used to tighten the article whereby the tension may be stored to the spool. Other embodiments are possible. Additionally, or alternatively, the fixation member of the lacing system may include a flange shaped complementary to the panel. Additionally, or alternatively, the lumen of the lacing system may extend between the entry aperture and the exit apertures in an arcuate configuration, so that the lumen may be guided through the fixation member in a gentle manner with minimized frictional resistance. Additionally, or alternatively, the plurality of guide members the lacing system may be configured to direct lacing along the panel of the article with or without overlap to the at least one lacing entry aperture and through the lacing exit aperture. Such a feature may be selected as desired and may be implementation-specific. Additionally, or alternatively, the tensioning component of the lacing system may be a ring-shaped element that may be snap-fit coupleable to the spool protrusion. Additionally, or alternatively, the spool protrusion and the tensioning component of the lacing system may each comprise a plurality of traction members that when engaged inhibit rotation of the tensioning component when the tensioning component is secured to the spool protrusion. Such a feature may prevent unwanted or undesired loosening of the tension member when the tensioning component is positioned to the spool protrusion. Other embodiments are possible. In another aspect, a lacing system for tightening an article is disclosed. The lacing system may include or comprise first plate coupleable to a first panel of the article and defining at least one lacing entry aperture, a lacing exit aperture, and a keyed protrusion that is positioned to a complementary recess of a second plate of the lacing system to form a groove with a lacing fixation post. In this example, the keyed protrusion and complementary recess may facilitate secure coupling of the first plate with the second plate. Other embodiments are possible. The lacing system may further include or comprise a lacing tensioner coupleable to lacing protruding from the lacing exit aperture and to a periphery of the groove so that the lacing tensioner is securable to the groove when lacing protruding from the lacing exit aperture is wound to the lacing fixation post for tightening the article by pulling together a second panel and a third panel of the article. Other embodiments are possible. Additionally, or alternatively, the first plate of the lacing system may further define a first plurality of ridged flutes extending radially from the keyed protrusion in a spoke pattern, and the second plate further defining a second plurality of ridged flutes extending radially from the recess in the spoke pattern and offset the first plurality of ridged flutes. Such a feature may maintain lacing tension when lacing protruding from the lacing exit aperture is wound to the lacing fixation post for tightening the article. Additionally, or alternatively, the lacing system may include a plurality of lacing guide members coupleable to the first panel to direct lacing along the first panel to the at least one lacing entry aperture and through the lacing exit aperture. Additionally, or alternatively, the lacing system may include a fastener positioned through an aperture of the keyed protrusion and an aperture of the recess to rigidly secure the keyed protrusion to the recess. Other embodiments are possible. In another aspect, a method for tightening an article using a lacing system is disclosed. The lacing system may include one or more of the features: a fixation member coupled to the article, the fixation member having at least one entry aperture and an exit aperture with a lumen extending therebetween, and also having a spool with a fixation post; a tension member having an intermediate portion slidably disposed within the lumen of the fixation member so that a proximal portion of the tension member is positioned on a proximal side of the fixation member and a distal portion of the tension member is positioned on a distal side of the fixation member; a plurality of guide members coupled to the article on the proximal side of the fixation member to guide the proximal portion of the tension member along/about the article to the fixation member; and a tensioning component coupled to the distal portion of the tension member. Further, the method may include or comprise tensioning the tension member via the tensioning component to effect sliding of the tension member within the lumen and thereby tighten the article by shortening the length of the proximal portion of the tension member. The method may further include or comprise winding the tension member about the fixation post via the tensioning component to maintain a tightness of the article, wherein the tensioning component is securable to the spool of the fixation member. Additionally, or alternatively, the method may include or comprise securing the tensioning component to the spool of the fixation member. Such a feature may allow for storage of the tensioning component when not in use. Additionally, or alternatively, the method may include or comprise positioning the tension member to the lumen of the fixation member to lace the tension member to the fixation member. Additionally, or alternatively, the method may include or comprise positioning the tension member to the plurality of guide members to lace the tension member to the plurality of guide members with or without overlap of the tension member. Additionally, or alternatively, the method may include or comprise positioning the tension member to the tensioning component to couple the tension member to the tensioning component. Additionally, or alternatively, the method may include or comprise winding the tension member within a gap about the fixation post that includes a plurality of radially offset ridged flutes to engage and maintain tension to the tension member. Additionally, or alternatively, the method may include or comprise winding excess length of the tension member within a gap about the fixation post to store the excess length of tension member about the fixation post. Other embodiments are possible. Although not so limited, an appreciation of the various aspects of the present disclosure along with associated benefits and/or advantages may be gained from the following discussion in connection with the drawings. DESCRIPTION OF THE DRAWINGS FIG. 1 shows a first lace fixation assembly. FIG. 2 shows a first plate of the assembly of FIG. 1 . FIG. 3 show a first view of a first and second plate of the assembly of FIG. 1 . FIG. 4 shows a second plate of the assembly of FIG. 1 . FIG. 5 show a second view of a first and second plate of the assembly of FIG. 1 . FIG. 6 shows a tensioning component of the assembly of FIG. 1 . FIGS. 7A-C show various views of a guide member of a first lace fixation system. FIGS. 8A-C show various views of a first lace fixation system. FIG. 9 shows a view of another lace fixation system. FIGS. 10A-D show various views of a second lace fixation assembly. FIGS. 11A-C show various exploded views of the assembly of FIG. 9 . FIGS. 12A-C show multiple embodiments of the assembly of FIG. 9 . FIG. 13 shows a first cross-section A-A of the assembly of FIG. 9 . FIG. 14 shows a second cross-section B-B of the assembly of FIG. 9 . FIG. 15 shows a view of still another lace fixation system. FIGS. 16A-B show various views of still another lace fixation system. FIG. 17 shows a view of still another lace fixation system. FIG. 18 shows a view of still another lace fixation system. FIGS. 19A-E show various views of still another lace fixation system. FIG. 20 shows a view of still another lace fixation system. FIG. 21 shows a view of still another lace fixation system. FIG. 22 shows a view of still another lace fixation system. FIGS. 23A-C show various views of a third lace fixation assembly. FIGS. 24A-B show various views of a fourth lace fixation assembly. FIG. 25 shows various views of a fifth lace fixation assembly. In the appended figures, similar components and/or features may have the same numerical reference label. Further, various components of the same type may be distinguished by following the reference label by a letter that distinguishes among the similar components and/or features. If only the first numerical reference label is used in the specification, the description is applicable to any one of the similar components and/or features having the same first numerical reference label irrespective of the letter suffix. DETAILED DESCRIPTION Different methods for closing or tightening shoes or boots and other flexible or semi-rigid panels have evolved over the years. Conventional laces whether led through metal eyelets, webbing loops, or low friction guides, have stood the test of time and remain popular. Mechanical systems using rotary dials, serrated grip surfaces and other designs may provide alternatives to knot-secured laces. Hook and loop engagements as well as elastic straps may also serve well in some applications. Currently available designs though present certain drawbacks. For example, conventional laces require the tying of a knot to secure the tightened adjustment, which obligates the user to untie the knot before any secondary adjustment can be made, unless or until the knot loosens of its own accord, requiring retying. Conventional lace systems are also limited to the use of relatively large diameter laces that are comfortable to grip by hand, the opposite desired characteristics for low-profile, efficient and effective closure. Rotary dials and other mechanical systems eliminate the knot problem and can make use of small diameter laces, but tend to be expensive to manufacture, to the point that they can represent up to 50% of the cost of a given pair of footwear. Some knotless fixation systems self-store excess lace while others require excess lace to be gathered and placed into a pocket on the boot, which is an inconvenient and inelegant solution. Given the harsh environment of daily use, often in climate extremes, mechanical system latching performance may also be problematic, often when a secure closure is needed most. Hook and loop and elastic systems also suffer performance loss in wet and/or freezing conditions, while being limited in the adjustment range and security of their closure. In addition to fixation issues, many lace systems suffer from excessive friction which can prevent the lace from exerting sufficient closure force in the area farthest from the point where tension is applied. This friction can have many causes including the lace material characteristic, the lace turning guides, the sliding of the lace over high friction surfaces, and also the points at which opposing laces cross over one another. In this aspect of lace function, the dilemma becomes one in which the more tension applied to tighten the closure, the more frictional force is created and the more difficult it becomes to obtain the desired closure. The present disclosure addresses these and other issues by providing a non-complex, inexpensive, non-mechanical, low-friction, knotless closure system with self-storage of excess lace. For instance, referring now collectively to FIGS. 1-8 , first lace fixation assembly 100 and first lace fixation system 102 are shown in accordance with the present disclosure. In general, first assembly 100 includes first plate 104 , second plate 106 , tensioning component 108 , and fastener 110 . FIG. 1 for example illustrates these respective components of first assembly 100 in an assembled configuration. First system 102 includes first assembly 100 , guide members 112 , and tension member 114 . FIG. 8A for example shows these respective components of first system 102 in an assembled configuration. In the example embodiment, tension member 114 is laced through first plate 104 of first assembly 100 via arcuate slots 116 that guide ends of tension member 114 from entry apertures 118 to exit aperture 120 . FIG. 2 for example illustrates entry apertures 118 and exit aperture 120 , and FIG. 3 for example illustrates arcuate slots 116 . Tension member 114 is further laced through guide members 112 via opposing grooves 122 so that tension member 114 does not overlap onto itself when laced thereto. Both first assembly 100 , at least in part, and guide members 112 are coupled to front panel 124 of boot 126 , and tensioning end 128 of tension member 114 is coupled to tensioning component 108 at notch 130 of tensioning component 108 . FIGS. 8A-B for example illustrate coupling of first assembly 100 and guide members 112 to boot 126 as well as tension member 114 to tensioning component 108 . In practice, tightening of boot 126 is performed or perfected by application of pulling force to tensioning component 108 , forcing first side panel 132 and second side panel 134 of boot 126 together. While maintaining pulling force, tensioning component 108 is used to wrap tension member 114 into channel or groove 136 that is formed between first plate 104 and second plate 106 . FIG. 5 for example illustrates groove 136 formed between first plate 104 and second plate 106 . Here, initial wrapping of tension member 114 into groove 136 forces tension member 114 into friction gap 138 that has surfaces along the length of which imparts force on tension member 114 when positioned thereto so that tension is generally maintained on tension member 114 when pulling force is removed, as discussed further below. Further wrapping of tension member 114 into groove 136 forces portions of tension member 114 into storage gap 140 . Storage gap 140 within groove 136 is therefore generally wider than friction gap 138 as storage gap 140 serves a different purpose than friction gap 138 in that it is used to store excess length of tension member 114 . Tension member 114 as wrapped onto itself though within both friction gap 138 and storage gap 140 imparts force on itself when positioned thereto, so that tension is generally maintained on tension member 114 when pulling force is removed. Wrapping of tension member 114 into groove 136 proceeds until length of tension member 114 protruding from exit aperture 120 is substantially wound into groove 136 . Tensioning component 108 is then generally snap-coupled onto first assembly 100 at groove 136 . Tensioning component 108 may be decoupled from first assembly 100 by application of leverage similar to that applied when opening a bottle having a cap, and may be used to unwind tension member 114 thereby loosening first side panel 132 and second side panel 134 of boot 126 . First side panel 132 and/or second side panel 134 may then be opened to allow exit, or tension reapplied to tension member 114 as desired. Such an implementation may be beneficial or advantageous in many respects. For example, knotting of tension member 114 is not required, excess length of tension member 114 is stored to first assembly 100 without additional steps, and through the use of tensioning component 108 , there is no need for a user to physically touch tension member 114 . Still other benefits and/or advantages are possible as well. Referring now specifically to FIGS. 1-6 , first lace fixation assembly 100 is shown in accordance with the present disclosure. As mentioned above, first assembly 100 includes first plate 104 , second plate 106 , tensioning component 108 , and fastener 110 . When assembled, axle- or post-like keyed portion 142 formed on protrusion 144 of first plate 104 , as shown for example in FIG. 2 , is positioned to complementary recess 146 of second plate 106 , as shown for example in FIG. 4 . Additionally, fastener 110 is positioned to both second plate aperture 148 that is adjacent to recess 146 and first plate aperture 150 that is formed within keyed portion 142 to secure first plate 104 with second plate 106 . In the example embodiment, keyed portion 142 and recess 146 are star-shaped in cross-section. Other embodiments are however possible, and shape of keyed portion 142 and recess 146 may be implementation-specific. Further, as mentioned above, tensioning component 108 is generally snap-fit coupleable to groove 136 that is formed between first plate 104 and second plate 106 . Rotational movement of tensioning component 108 is limited or restricted when positioned to groove 136 by interlock of bumps or ridges 152 formed on both second plate 106 and tensioning component 108 , illustrated for example at FIG. 4 and at FIG. 6 . Friction gap 138 within groove 136 is defined by first ridged flutes 154 that extend in a spoke pattern from keyed portion 142 of first plate 104 , and second ridged flutes 156 that extend in the spoke pattern from recess 146 of second plate 106 . FIG. 2 for example illustrates first ridged flutes 154 , and FIG. 4 for example illustrates second ridged flutes 156 . It is contemplated that more or fewer ridged flutes may be utilized in any pattern as desired, and further number and shape of first ridged flutes 154 and second ridged flutes 156 may be implementation-specific. In the example embodiment, when first plate 104 is coupled with second plate 106 , first ridged flutes 154 and second ridged flutes 156 are rotationally offset from each other so as to form a path for tension member 114 similar to that formed by an interdigitated comb structure. In this instance, however, fingers of the comb structure are interdigitally arranged along a circle. In this manner, first ridged flutes 154 and second ridged flutes 156 are configured and arranged to impart force on tension member 114 when tension member 114 is positioned to friction gap 138 within groove 136 , so that tension is generally maintained on tension member 114 when pulling force is removed. Referring now specifically to FIGS. 7A-C , a particular one of guide members 112 is shown in accordance with the present disclosure. As mentioned above, tension member 114 is laced through guide members 112 via opposing grooves 122 so that tension member 114 does not overlap onto itself. In general, grooves 122 positioned on each side of mounting aperture 158 provide a curved low-friction pathway for tension member 114 as it interfaces with panels 124 , 132 , and 134 of boot 126 , similar to arcuate slots 116 of first plate 104 that provide a low-friction pathway for tension member 114 from entry apertures 118 to exit aperture 120 . Whereas a typical lacing pattern may route laces back and forth between opposing panels, with laces crossing each other at various points along the center line of a particular panel, guide members 112 eliminate lace crossing and resulting friction that which may impede closure. It is contemplated that any number of guide members 112 may be employed to realize desired closure characteristics while maintaining the lowest possible lace system friction. In the present example, with guide members 112 attached to center portion of front panel 124 , tension member 114 is guided from first side panel 132 through a particular one of guide members 112 , and back to first side panel 132 . Similarly, tension member 114 is guided from second side panel 134 through a particular one of guide members 112 , and back to second side panel 134 . Tension member 114 thus does not overlap onto itself and does not bind, chafe, or create excess friction. It is contemplated that body 160 of guide members 112 may be curved to generally match the shape of front panel 124 or other intermediate panel onto which they are coupled. Further, profile or thickness 162 of guide members 112 may be defined such that tension member 114 is raised above a surface of an intermediate panel to further reduce friction. Various methods may be employed to attach guide members 112 to front panel 124 , such as in a manner that allows guide members 112 to self-align under loads presented by tension member 114 . Further, in order to facilitate injection molding with minimal tooling complexity, in one embodiment the bearing surface of the guide members 112 may be formed by alternating grooves in top and bottom surfaces. This arrangement may sufficiently capture tension member 114 , keeping tension member 114 bearing upon the desired radius surface, while not requiring any sliding elements in the injection mold. Referring now to FIG. 9 , another lace fixation system 902 is shown in accordance with the present disclosure. System 902 is similar to first lace fixation system 102 as described above in many respects. For example, system 902 includes first lace fixation assembly 100 of at least FIG. 1 coupled to front panel 904 of boot 906 . In the example embodiment, however, tension member 908 is laced through guide members 910 so as to overlap or cross itself. Guide members 910 in FIG. 9 are webbing or fabric strips that are sewn or otherwise coupled to panels of the article. The webbing or fabric strips 910 include loops through which the tension member 908 is inserted. The webbing or fabric strips 910 may be angled or directed to guide the tension member 908 about the article as desired. In practice though, tightening of boot 906 using first assembly 100 may be performed in a manner similar to that described above. Further, FIG. 9 demonstrates flexibility of first assembly 100 in that tensioning component 108 may be coupled to groove 136 (e.g., see FIG. 5 ) that is formed between first plate 104 and second plate 106 without orientation-specific keying. In other words, tensioning component 108 may be coupled to groove 136 in any particular orientation. For example, FIG. 8C illustrates tensioning component 108 positioned to groove 136 so that notch 130 is orientated towards guide members 112 . In contrast, FIG. 9 illustrates tensioning component 108 positioned to groove 136 so that notch 130 is orientated away from guide members 910 . Referring now to FIGS. 10A-16B , second lace fixation assembly 1000 and second lace fixation system 1002 are shown in accordance with the present disclosure. In general, second assembly 1000 includes plate 1004 and tensioning component 1006 . FIG. 10B for example illustrates these respective components of second assembly 1000 in an assembled configuration. Second system 1002 includes second assembly 1000 , guide members 1008 , and tension member 1010 . FIG. 15 for example illustrates these respective components of second system 1002 in an assembled configuration. In the example embodiment, tension member 1010 is laced through plate 1004 of second assembly 1000 via plate apertures 1011 that guide tension member 1010 through plate 1004 , and further is laced through guide members 1008 so that tension member 1010 overlaps onto itself. FIG. 12C for example illustrates plate apertures 1011 , and FIG. 15 and FIG. 16A for example illustrate lacing of tension member 1010 through guide members 1008 that are coupled to boot 1014 , and lacing of tension member 1010 through plate 1004 , respectively. Other embodiments though are possible. For example, it is contemplated that guide members 112 as discussed above may be used in place of guide members 1008 . Both second assembly 1000 , at least in part, and guide members 1008 are coupled to front panel 1012 of boot 1014 , and tensioning end 1016 of tension member 1010 is coupled to tensioning component 1006 at component apertures 1018 . FIGS. 11A-B for example illustrate component apertures 1018 of tensioning component 1006 , and FIG. 16A for example illustrates tensioning end 1016 of tension member 1010 coupled to tensioning component 1006 . In the example embodiment, component apertures 1018 flare open into elongated slots on bottom side 1005 of tensioning component 1006 to gently guide tension member 1010 therethrough, and plate 1004 includes primary surface 1007 that may be curved to at least partially conform to shape of panel 1012 of boot 1014 , similar to first plate 104 of first assembly 100 shown at least in FIG. 1 . In practice, tightening of boot 1014 is performed or perfected by application of pulling force to tensioning component 1006 , forcing first side panel 1020 and second side panel 1022 of boot 1014 together. While maintaining pulling force, tensioning component 1006 is used to wrap tension member 1010 into channel or groove 1024 formed by plate 1004 . FIG. 10B for example illustrates groove 1024 formed by plate 1004 . Wrapping of tension member 1010 tightly onto itself within groove 1024 fixes tension member 1010 in place, so that tension is generally maintained on tension member 1010 when pulling force is removed. Wrapping of tension member 1010 into groove 1024 proceeds until length of tension member 1010 protruding from component apertures 1018 is substantially wrapped into groove 1024 . Tensioning component 1006 is then snap-coupled onto flange 1026 of plate 1004 so that locking surface 1028 of at least one flexible tab 1030 of tensioning component 1006 engages with locking surface 1032 of flange 1026 adjacent to groove 1024 . FIG. 14 in a particular instance illustrates tensioning component 1006 snap-coupled onto flange 1026 of plate 1004 . In the example embodiment, tensioning component 1006 may subsequently be decoupled from plate 1004 by application of leverage to tensioning component 1006 similar to that of opening certain types of aspirin containers for example, and may be used to unwind tension member 1010 , thereby releasing force imparted on first side panel 1020 and second side panel 1022 of boot 1014 . First side panels 1020 and/or second side panel 1022 may then be opened to allow exit, or tension reapplied to tension member 1010 as desired. Such an implementation may be beneficial or advantageous in many respects, including at least those discusses above in connection with first assembly 100 . Further, referring now specifically to FIGS. 16A-B , flexibility of second assembly 1000 is demonstrated in that tension member 1010 may be laced through plate 1004 of second assembly 1000 in a particular direction as desired. For example, FIG. 16A illustrates tension member 1010 laced through plate 1004 of second assembly 1000 in a direction extending away from front end of shoe 1014 , so that tightening of shoe 1014 is perfected by application of pulling force generally in direction A. In contrast, FIG. 16B illustrates tension member 1010 laced through plate 1004 of second assembly 1000 in a direction extending towards front end of boot 1014 , so that tightening of boot is perfected by application of pulling force generally in direction B. Referring now specifically to FIGS. 11-14 , second lace fixation assembly 1000 is shown in accordance with the present disclosure. FIGS. 12A-C in particular show second assembly 1000 in varying dimension, generally increasing in size from FIG. 12A proceeding in order to FIG. 12C . As mentioned above, second assembly 1000 includes plate 1004 and tensioning component 1006 . When assembled, keyed aperture 1034 formed within flange 1026 of plate 1004 is positioned to complementary post 1036 of tensioning component 1006 . FIG. 11A and FIG. 11B for example illustrate keyed aperture 1034 formed within flange 1026 of plate 1004 , and post 1036 of tensioning component 1006 . In the example embodiment, keyed aperture 1034 and post 1036 are peripherally notched. Other embodiments are however possible. Tensioning component 1006 is snap-fit coupleable to keyed aperture 1034 formed within flange 1026 of plate 1004 by at least one flexible tab 1030 of tensioning component 1006 that has locking surface 1028 that engages with locking surface 1032 of flange 1026 adjacent groove 1024 . FIG. 14 for example illustrates flexible tab 1030 of tensioning component 1006 that has locking surface 1028 that engages with locking surface 1032 of flange 1026 adjacent to groove 1024 . In the example embodiment, rotational movement of tensioning component 1006 when coupled to plate 1004 is limited or restricted because post 1036 is rigidly fixed to plate 1004 at mounting surface 1038 . Referring now to FIG. 17 , still another lace fixation system 1702 is shown in accordance with the present disclosure. System 1702 is similar to second lace fixation system 1002 as described above in many aspects. For example, system 1702 includes second lace fixation assembly 1000 of at least FIG. 10 coupled to panel 1704 of item 1706 . In this example, however, second assembly 1000 is not coupled to a central panel of item 1706 , and further tension member 1708 is alternately laced through guide members 1710 terminating at end 1712 . In practice though, tightening of item 1706 using second assembly 1000 may be performed in a manner similar to that described above. Further, FIG. 17 demonstrates flexibility of second assembly 1000 in that second assembly 1000 may generally be coupled to a particular item at any location as desired, such as to an eyestay of a shoe as illustrated in FIG. 17 . Termination at end 1712 as shown in FIG. 17 may increase the tension imparted to tension member 1708 as the system is used to close item 1706 . Still other lace fixation systems embodiments are possible. For example, referring now to FIG. 18 , still another lace fixation system 1802 is shown in accordance with the present disclosure. System 1802 is similar to second lace fixation system 1002 as described above in many aspects. For example, system 1802 includes first instance 1000 a of second lace fixation assembly 1000 of at least FIG. 10 coupled to first panel 1804 of item 1806 . In this example, however, system 1802 further includes second instance 1000 b of second lace fixation assembly 1000 coupled to second panel 1808 of item 1804 , and tension member 1810 is coupled to fixed guide 1812 positioned to central panel 1814 of item 1806 . In some embodiments, first instance 1000 a of second assembly 1000 and second instance 1000 b of second assembly 1000 may be sized differently, for example as illustrated in FIG. 12 . Such an implementation as shown in FIG. 18 may be an example of a zone or zonal tightening system, whereby tension imparted on first length 1816 of tension member 1808 may be controlled by first instance 1000 a of second assembly 1000 , and tension imparted on second length 1818 of tension member 1808 may be controlled by second instance 1000 b of second assembly 1000 . Tension member 1810 may be fixedly coupled with fixed guide 1812 (i.e., the tension member 1810 may be prevented from sliding through guide 1812 ) to allow zonal tensioning of a proximal and distal portion of item 1806 . Still other lace fixation system embodiments are possible. For example, referring now to FIGS. 19A-E , still another lace fixation system 1902 is shown in accordance with the present disclosure. System 1902 is similar to second lace fixation system 1002 as described above in many aspects. For example, system 1902 includes embodiment 1000 a of second lace fixation assembly 1000 of at least FIG. 10 coupled to panel 1904 of item 1906 . In this example, however, system 1902 includes tension member 1908 coupled to fixed guide 1910 positioned to central panel 1912 of item 1906 . As shown in the sequence of FIGS. 19A-E , tension member 1908 may be positioned to guide members 1914 and fixed guide 1910 so that tension member 1908 may be wrapped and coupled to embodiment 1000 a of second assembly 1000 in a manner such as described above. In particular, tension member 1908 may be initially laced to guide member 1914 a and guide member 1914 b positioned in a lower portion of the item, and then laced through fixed guide 1910 as shown in FIG. 19C , such as by inserting tension member 1908 through a lumen of fixed guide 1910 . Tensioning component 1006 may then be pulled in direction X to apply tension to first length 1916 of tension member 1908 , thereby pulling the lower portion of side panel 1918 and side panel 1920 together. Tension member 1908 may then be wrapped around a post of fixed guide 1910 to lock or maintain a tension of first length 1916 of tension member 1908 and thereby secure the lower portion in a tightened arrangement. Tension member 1908 may then be laced to guide member 1914 c and guide member 1914 d in an upper portion of the item. Tensioning component 1006 may then be pulled in direction Y to apply tension to second length 1922 of tension member 1908 , thereby pulling the upper portion of side panel 1918 and side panel 1920 together. Tension member 1908 may then be wrapped into channel or groove 1024 formed by plate 1004 to lock or maintain a tension of second length 1922 of tension member 1908 and thereby secure the upper portion in a tightened arrangement. Such an implementation as shown in FIGS. 19A-E may be an example of a zone or zonal tightening system, whereby tension imparted on first length 1916 of tension member 1908 may be controlled or maintained due to coupling of tension member 1908 to fixed guide 1910 , and tension imparted on second length 1922 of tension member 1908 may be controlled or maintained due to coupling of tension member 1908 to plate 1004 . Still many other lace fixation system embodiments are possible. Referring now to FIG. 20 , still another lace fixation system 2002 is shown in accordance with the present disclosure. System 2002 is similar to both first lace fixation system 102 and second lace fixation system 1002 as described above in many respects. For example, system 2002 includes first lace fixation assembly 100 of at least FIG. 1 coupled to first panel 2004 of item 2006 , and also includes second lace fixation assembly 1000 of at least FIG. 10 coupled to second panel 2008 of item 2006 . In this example, however, system 2002 includes first tension member 2010 coupled to first assembly 100 in a manner similar to that described above, and also includes second tension member 2012 coupled to second assembly 1000 in a manner similar to that described above. Here, second tension member 2012 is shown partially in phantom line as a portion of second tension member 2012 is routed generally underneath outer shell 2014 of item 2006 , such as through tubing positioned under the upper of a boot. Such an implementation may be another example of a zone or zonal tightening system, whereby tension imparted on first tension member 2010 may be controlled by first assembly 100 , and tension imparted on second tension member 2012 may be controlled by second assembly 1000 . In the illustrated embodiment, first tension member 2010 and first assembly 100 is used to tighten an upper portion of a boot while second tension member 2012 and second lace fixation assembly 1000 is used to tighten a lower portion of a boot. Still other lace fixation system embodiments are possible. Referring now to FIG. 21 , still another lace fixation system 2102 is shown in accordance with the present disclosure. System 2102 is similar to second lace fixation system 1002 as described above in many respects. For example, system 2102 includes second lace fixation assembly 1000 of at least FIG. 10 coupled to panel 2104 of item 2006 . In this example, however, second assembly 1000 is not coupled to a central or offset panel of item 2106 , and instead is coupled to rear portion 2108 of item 2106 , such as heel portion of a shoe. Further, tension member 2110 is laced to second assembly 1000 at a point furthest possible from guide members 2112 of item 2106 , such as by being routed through tubing coupled with and/or positioned under an upper material layer of the shoe. In practice though, tightening of item 2106 using second assembly 1000 may be performed in a manner similar to that described above. Further, FIG. 21 demonstrates flexibility of second assembly 1000 in that second assembly 1000 may generally be coupled to a particular item at any location as desired. Still other lace fixation system embodiments are possible. Referring now to FIG. 22 , still another lace fixation system 2202 is shown in accordance with the present disclosure. System 2202 is similar to lace fixation system 2002 of FIG. 20 as described above in many respects. In this example, however, system 2202 exhibits an alternate embodiment of first lace fixation assembly 100 . In particular, lace fixation assembly 2204 coupled to first panel 2206 of item 2208 includes reel assembly mechanism 2210 having a knob or dial component 2212 that is rotatable in a first direction (e.g., clockwise) to wind the tension member 2216 about a channel or groove of a spool (not shown) positioned under the knob 2212 and within a housing 2214 of the reel assembly mechanism 2210 . The tension member 2216 is laced and/or positioned around one or more guides of an upper portion of item 2208 (i.e., boot). The reel assembly mechanism 2210 is used to tighten the upper portion of item 2208 by tensioning the tension member 2216 via reel assembly mechanism 2210 . In some embodiments, the reel assembly mechanism 2210 may be rotated in a second direction (i.e., counter-clockwise) to loosen the tension in tension member 2216 and thereby loosen the upper portion of item 2208 . In other embodiments, the knob 2212 may be grasped and moved axially upward to disengage internal components of reel assembly mechanism 2210 and thereby release the tension on tension member 2216 . Second assembly 1000 may be used to tension a lower portion of item 2208 as described in the embodiment of FIG. 20 . Still other lace fixation assembly embodiments are possible. For example, referring now to FIGS. 23A-C , third lace fixation assembly 2300 is shown in accordance with the present disclosure. In the example embodiment, tension member 2302 is laced through plate 2304 of third assembly 2300 via lumen or passage 2306 that guides tension member 2302 through plate 2304 , and tensioning end 2308 of tension member 2302 is coupled to tensioning component 2310 at component apertures 2312 . As shown in particular by the sequence of FIG. 23C , tensioning component 2310 may initially be pulled in direction C so that tension member 2302 in turn is pulled through passage 2306 . Tensioning component 2310 may then be flipped or positioned back over plate 2304 whereby portions of tension member 2302 are engaged with ridged friction surfaces 2314 within channel 2316 of plate 2304 . The ridged friction surfaces 2314 engage with tension member 2302 to lock or otherwise maintain the tension member 2302 in a tensioned stated. FIG. 23A and FIG. 23B too for example illustrates portions of tension member 2302 engaged with ridged friction surfaces 2314 within channel 2316 of plate 2304 . Tensioning component 2310 may then be pulled in direction D that is generally opposite direction C so that slack of tension member 2302 is taken up and portions of tension member 2302 are fully engaged with ridged friction surfaces 2314 within channel 2316 to lock or otherwise maintain the tension member 2302 in the tensioned stated. Tensioning component 2310 may then be used to wrap tension member 2302 within second channel 2318 of plate 2304 in rotational direction E and then snap-coupled to flange 2138 of plate 2304 in a manner similar to that described above in connection with tensioning component 1006 . Second channel 2318 may be separated from channel 2316 via a flange or other partition member. In the example embodiment, plate 2304 and tensioning component 2310 of at least FIG. 23 are configured in a manner substantially similar to plate 1004 tensioning component 1006 of at least FIG. 10A-D , with at least the exception of ridged friction surfaces 2314 . Still other lace fixation assembly embodiments are possible. Referring now to FIGS. 24A-B , fourth lace fixation assembly 2400 is shown in accordance with the present disclosure. In the example embodiment, fourth assembly 2400 is substantially similar to second lace fixation assembly 1002 as described above. Fourth assembly 2400 though is configured to exhibit coiler functionality. As shown in particular by the sequence of FIG. 24B , tensioning component 1006 may initially be pulled in direction F so that tension member 1010 in turn is pulled through plate 1004 . Post 2402 of plate 1004 may then be rotated in direction G to pull and wind tension member 1010 to groove 1024 formed by plate 1004 (e.g., see FIG. 10 ). Tensioning component 1006 may then be snap-coupled onto flange 1026 of plate 1004 in manner as described above. In the example embodiment, post 2402 of plate 1004 may be configured and arranged as a rotary dial having a clock spring or spiral-wound torsion spring so that tension member 1010 may be automatically wound to groove 1024 formed by plate 1004 without a user having to use tensioning component 1006 to wrap tension member 1010 to groove 1024 as describe above. In this manner, the user may simply pull tensioning component 1006 in direction F and then release tensioning component 1006 or gently guide tensioning component 1006 as post 2402 automatically rotates in direction G to wind tension member 1010 about groove 1024 . In other embodiments, the user may rotate post 2402 in direction G to wind the tension member 1010 about groove 1024 . In some embodiments, post 2402 may further be configured and arranged to exhibit push-to-lock/pull-to-unlock functionality whereby when tension member 1010 is fully wrapped to groove 1024 tensioning component 1006 may be pressed to lock second assembly 1002 . A reverse operation may be performed to unlock second assembly 1002 so that tension member 1010 may be unwound from groove 1024 . Still other lace fixation assembly embodiments are possible. Referring now to FIG. 25 , fifth lace fixation assembly 2500 is shown in accordance with the present disclosure. In the example embodiment, fifth lace fixation assembly 2500 is substantially similar to second lace fixation assembly 1002 as described above. Fifth assembly 2500 though is configured to exhibit incremental tightening/loosening functionality. For example, as shown in particular by the sequence of FIG. 25 , tensioning component 1006 may initially be pulled in direction H so that tension member 1010 in turn is pulled through plate 1004 . Tensioning component 1006 may then be used to wrap tension member 1010 to groove 1024 and then snap-coupled onto flange 1026 of plate 1004 in manner as described above. Subsequently, a fine tuning operation may be performed to increase or release tension on tension member 1010 . In particular, tensioning component 1006 may be incrementally rotated in a clockwise direction in a fixed ratcheting motion to increase tension on tension member 1010 , or incrementally rotated in a counterclockwise direction in the fixed ratcheting motion to release tension on tension member 1010 . In the example embodiment, post 2402 of plate 1004 (e.g., see FIG. 24 ) may be configured and arranged as a ratcheted rotary dial so that tension on tension member 1010 may be increased or decreased as desired, without having to decouple tensioning component 1006 from plate 1004 . Although the various disclosed lace fixation assemblies and systems are described in the context of a closure system for footwear or other panels desired to be closed toward one another, it will be appreciated that the designs may be optimized for a variety of other uses in which a lace or cord is desired to be removably secured at various tension levels or adjustment lengths. Examples include: a) fixation of high tensile rigging aboard ships, allowing for easy adjustment of a given line with secure fixation, b) orthopedic bracing products, c) garment closures, d) equestrian accessories, e) wakeboard boots, f) kitesurfing line adjustments, g) backpack and luggage closures. Having described several embodiments, it will be recognized by those of skill in the art that various modifications, alternative constructions, and equivalents may be used without departing from the spirit of the invention. Additionally, a number of well-known processes and elements have not been described in order to avoid unnecessarily obscuring the present invention. Accordingly, the above description should not be taken as limiting the scope of the invention. As used herein and in the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “a process” includes a plurality of such processes and reference to “the device” includes reference to one or more devices and equivalents thereof known to those skilled in the art, and so forth. Also, the words “comprise,” “comprising,” “include,” “including,” and “includes” when used in this specification and in the following claims are intended to specify the presence of stated features, integers, components, or steps, but they do not preclude the presence or addition of one or more other features, integers, components, steps, acts, or groups.

1a

TECHNICAL FIELD This invention relates in general to electrical devices, and more particularly, to an electrical device such as an intravascular pressure guide wire having a precision interconnect. BACKGROUND Medical guide wires having miniature pressure sensors are well known. Such pressure guide wires typically have a pressure sensor located at the guide wire's distal end that is used to measure the pressure within a patient's artery. Electrical conductors which are connected to the pressure sensor are passed through the inside of the guide wire to a set of electrical contacts or sleeves located at the proximal end of the guide wire. The electrical contacts on the guide wire are mated to external monitoring equipment using an interface cable. The external monitoring equipment can provide pressure information to the attending physician that is useful in the diagnosis for example of an arterial occlusion. An example of such a pressure guide wire is described in U.S. Pat. No. 5,715,827, entitled “Ultra Miniature Sensor and Guide Wire Using The Same and Method”. In FIG. 1 there is shown a prior art pressure measuring system 100 comprising a guide wire 10 placed within a patient 12 . The guide wire 10 is used with apparatus 20 that comprises rotary connector assembly 220 and a cable 214 that connects the rotary connector assembly 220 to an interface box 24 . Connector 32 which is part of the rotary connector assembly 220 electrically interconnects with interface box connector 34 . Interface box 24 is connected by cable 26 to a pressure monitoring console 28 , such as a WAVEMAP™ pressure monitoring instrument manufactured by EndoSonics, Inc., Rancho Cordova, Calif. Console 28 can display both proximal and distal pressure measurements as will has controls for calibrating the pressure wire 10 prior to its usage. Referring now to FIG. 2, there is shown a more detailed view of the prior art pressure guide wire 10 coupled to a rotary connector assembly 220 . As shown therein, pressure guide wire 10 can be manufactured utilizing the various constructions as shown and described in U.S. Pat. Nos. 5,163,445, 5,178,159 and 5,240,437. Guide wire 10 comprises a flexible elongate element 202 having a proximal and distal extremities 204 and 206 and which can be formed of suitable material such as stainless steel. The guide wire having an outside diameter for example of 0.018 inch or less and having a suitable wall thickness as for example, 0.001″ to 0.002″ and conventionally called a “hypotube” having a typical length of approximately 150-170 centimeters. A semiconductor pressure sensor 208 is located at the distal extremity of guide wire 10 . The proximal end of guide wire 10 is slid into a rotary connector 210 of the type described in U.S. Pat. Nos. 5,178,159 and 5,348,481 which is part of the rotary connector assembly 220 . A torquer 230 is typically clipped-on by a physician distal to the rotary connector 210 . Rotation of the torquer 230 causes rotation of guide wire 10 when used in connection with a catherization procedure in a manner well known to those skilled in the art. The proximal extremity 204 of the guide wire 10 is removably disposed within housing 212 of the type described in U.S. Pat. Nos. 5,178,159, 5,348,481 and 5,358,409. Located close to the distal extremity of guide wire 10 is a pressure sensor 208 which is used to measure pressure within a patient's blood vessels. Electrical contacts located within housing 212 make electrical contact with electrically conductive sleeves (not shown in FIG. 2) located on the proximal extremity 204 of guide wire 10 . The electrical contacts located in housing 212 allow for rotation of the guide wire while maintaining electrical contact with the conductive sleeves found in guide wire 10 , these conductive sleeves are electrically coupled to pressure sensor 208 . The electrical contacts in housing 212 are electrically connected to cable 214 that terminates in connector 32 . The connector 32 is connected to another mating connector 34 located on the interface box 24 . Interface box 24 provides signal buffering and voltage level adjustments between guide wire 10 and pressure monitoring console 28 . The electrically conductive sleeves 302 , 304 and 306 , which are located at the proximal extremity of guide wire 10 , are shown in FIG. 3 . In FIG. 4 there is shown an electrical schematic representation of the pressure sensor 208 which comprises two variable resistors 402 and 404 whose resistance values vary with changes in pressure as is known in the art. Pressure sensor 208 can be a semiconductor having a diaphragm as is well known in the art. The two resistors 402 and 404 are connected to the three electrically conductive sleeves or bands 302 , 304 and 306 located on the proximal extremity of guide wire 10 as shown. FIG. 5 shows an exploded isometric view of the prior art rotary connector assembly 220 including rotartary connector 210 and housing 212 . In operation, the proximal extremity of the flexible elongate member or pressure guide wire 10 is inserted into bore 501 with one hand while holding the rotary connector with the other hand. The nose piece 503 and the collar 504 are then pulled with fingers in a proximal direction against the force of the spring 508 to release the collet 502 and allow it to open. The guide wire 10 can then enter the bore 501 and pass through the inside of collet 502 and through bearing 510 . The guide wire 10 is then pushed further in until conductive sleeve 302 is making electrical contact with contact member 546 , conductive sleeve 304 is making electrical contact with contact member 544 and conductive sleeve 306 is making electrical contact with contact member 542 . Housing members 514 and 530 retain contacts 542 , 544 and 546 . A retaining ring 506 , which is inserted through an opening in bearing 510 , engages with and retains collet 502 . Connector 32 provides an interconnection with the interface box 24 through a cable as shown in FIG. 1 . A problem with the above noted design is that sometimes as the guide wire 10 is being rotated, the contact resistance between electrically conductive sleeves 302 , 304 and 306 located on the guide wire 21 and the corresponding electrical contacts located in housing 212 varies. This contact resistance variation is assumed to be caused by microscopic particles that get lodged between the pressure guide wire's conductive bands 302 , 304 and 306 and the corresponding spring contacts 546 , 544 and 542 . This change in contact resistance causes an error in the pressure measurement as determined by pressure monitoring console 28 , since this change in contact resistance affects the measurement of pressure sensor resistors 402 and 404 . An electrically equivalent circuit showing this change in contact resistance is shown in FIG. 8 . Pressure sensor 208 is shown coupled to sleeve contacts (conductive bands) 302 , 304 and 306 via electrical conductors. Sleeve contact 302 is shown coupled to contact 546 , sleeve contact 304 is shown coupled to contact 544 and sleeve contact 306 is shown coupled to contact 542 . Variable resistors 802 , 804 and 806 represent the variable contact resistance caused by the rotating connector interface. The resistance of resistors 802 , 804 and 806 vary as the pressure guide wire is rotated. As shown, contact resistance 802 is in series with sensor resistor 402 and contact resistance 806 is in series with sensor resistor 404 and thus any change in the contact resistance will affect the measurement of sensor 208 . A need thus exists in the art for a solution that can minimize electrical interconnection problems as the one described above. BRIEF DESCRIPTION OF THE DRAWINGS The features of the present invention, which are believed to be novel, are set forth with particularity in the appended claims. The invention, together with further objects and advantages thereof, may best be understood by reference to the following description, taken in conjunction with the accompanying drawings, in the several figures of which like reference numerals identify like elements, and in which: FIG. 1 is an illustration showing a prior art guide wire in conjunction with a patient undergoing a catheterization procedure for diagnosis or treatment. FIG. 2 shows a more detailed view of the prior art guide wire attached to a rotating connector assembly. FIG. 3 shows the prior art guide wire showing the electrically conductive sleeves located at the proximal extremity of the guide wire. FIG. 4 shows an electrical representation of the prior art pressure sensor attached to the electrically conductive sleeves. FIG. 5 shows an exploded view of the prior art rotary connector and housing used to receive the pressure guide wire. FIG. 6 shows a housing having contacts in accordance with the present invention. FIG. 7 shows a view of a pressure guide wire in accordance with the invention. FIG. 8 shows an electrical representation of the prior art electrical interconnection between the guide wire and the rotary connector. FIG. 9 shows an electrical representation of the electrical interconnection between the guide wire and rotary connector in accordance with the invention. FIGS. 10 and 11 show electrical schematics for the interface circuit in accordance with the present invention. FIG. 12 shows a simplified block diagram of the electrical schematics shown in FIGS. 10 and 11 in accordance with the invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT While the specification concludes with claims defining the features of the invention that are regarded as novel, it is believed that the invention will be better understood from a consideration of the following description in conjunction with the drawing figures, in which like reference numerals are carried forward. Referring now to FIG. 6, there is shown an electrical contact assembly 600 in accordance with the invention. Assembly 600 includes first and second housing members 602 and 604 that retain five guide wire spring contacts 606 - 614 . Assembly 600 takes the place of housing members 514 and 530 and contacts 542 , 544 and 546 in FIG. 5 . In FIG. 7, there is shown a pressure guide wire 700 in accordance with the invention. Similar to guide wire 10 , pressure guide wire 700 includes three conductive sleeves or contacts 702 , 704 and 706 . However, unlike guide wire 10 , the two outer contacts 702 and 706 are wider than the middle contact 704 . The wider sleeve contact 702 and 706 are designed so that they can make contact with two corresponding contacts each from among contacts 606 - 614 . Guide wire sleeve contact 702 is designed to make an electrical connection with contacts 606 and 608 and sleeve contact 706 makes electrical connection with contacts 612 and 614 when guide wire 700 is placed in assembly 600 . The center guide wire sleeve contact 704 makes electrical connection with center contact 610 . Housing assembly 600 has been designed to be backward compatible and will accept either the newly designed guide wire 700 or the prior art guide wire 10 . When guide wire 10 is inserted into assembly 600 , sleeve contact 306 makes connection with contact 612 , sleeve contact 304 makes connection with contact 610 and sleeve contact 302 makes connection with contact 608 . In FIG. 9, there is shown a simplified electrical representation of the preferred embodiment precision interconnect circuit which solves for the variable contact resistance's and provides for backward compatibility with both the old pressure guide wire 10 and the new pressure wire 700 . The pressure sensor 208 is coupled to sleeve contacts 702 , 702 ′, 704 , 706 and 706 ′ when a new pressure guide wire 700 is being used. When an old pressure guide wire 10 is being used, contacts 702 ′ and 706 ′ are not utilized since the outer sleeve contacts are not as wide as those shown in pressure wire 700 . In FIG. 9, contacts 702 ′ and 706 ′ are simply representing the extra wide sleeve contacts found in contacts 702 and 706 as shown in FIG. 7 . The variable contact resistance problem of the interconnection is highlighted within box 920 . Sleeve contacts 702 ′, 702 , 704 , 706 and 706 ′ are coupled to corresponding contacts 614 , 612 , 610 , 608 and 606 in the new design which form the input port for the interconnection circuit. When an old pressure guide wire 10 is attached, contacts 614 and 606 are not utilized. Switches 910 and 912 remain in the open position or first state when a new guide wire 700 is attached and are automatically placed in the closed position or second state when an old guide wire 10 is attached in response to a control signal. The control electronics for switches 910 and 912 will be discussed in detail further below. Switches 910 and 912 allow for the interconnect interface to be backward compatible and support both pressure guide wire 10 and the new pressure guide wire 700 . In the interconnection interface, new pressure guide wire 700 uses a 5-wire interconnection, while the old pressure guide wire uses a 3-wire interconnection. A pair of differential operational amplifiers or precision amplifiers 902 and 904 that have high impedance inputs and are part of the interface circuit allow for three low current paths. These paths take away the effect of changes in the contact resistance ( 924 , 926 and 928 ) from changes in the sensor resistors 402 and 404 . A reference current is provided to the sensor resistor 402 and 404 as shown in order to generate the appropriate voltage drops used for pressure change detection. Referring now to FIGS. 10 and 11, there is shown a full electrical schematic for the interface circuit which replaces the electronics found in interface box 24 . The circuitry shown in FIGS. 10 and 11 includes not only the circuitry needed to perform the precision interconnection as described above, but also provides the necessary signal conditioning circuitry needed to match the signal from the pressure sensor 208 to the pressure measurement console 28 . The signal conditioning circuitry will not be discussed in detail since it is not needed in the understanding of the present invention. The circuit shown in FIG. 10 is the mother board and the circuit shown in FIG. 11 is a daughter board which in the preferred embodiment comprise two separate printed circuit boards which are coupled together. The two circuit boards are coupled together using jack connectors J 1 and J 2 found in the circuit of FIG. 10 which mate with corresponding plug connectors P 1 and P 2 located on the circuit of FIG. 11 . Connector “JP2” 1002 in FIG. 10 is coupled to the pressure sensor resistors 402 and 404 which are coupled through via connectors 32 and 34 into the interface circuitry. The five sensor contacts are coupled to pins 2 , 4 , 6 , 8 and 10 of connector JP2 as shown in diagram 1014 . Differential amplifiers 902 and 904 as previously shown in FIG. 9 that are part of amplifier stage 1008 , provide a gain of approximately two. The output of these amplifiers are fed into a 2 pole, 250 Hertz low pass filter (LPF) stage 1012 which provides for a gain of approximately twenty. The outputs of the LPF stage 1012 are coupled to connector “JP1” 1010 that in turn couples into the pressure monitoring console 28 . Pins 7 and 9 of connector JP1 are inputs to the pressure monitoring console, while pins 1 , 2 , 4 , 6 , 8 , 10 , 14 , 15 and 16 are signals coming from the pressure console 28 into the interface circuitry. Although not important to the understanding of the present invention, circuit block 1004 , provides offset voltage correction for the interface between the pressure guide wire 700 and the pressure monitoring console 24 . Box 1016 shows the internal interconnections of connector J 2 . In FIG. 11, operational amplifiers U 5 A, U 1 A and U 1 B form a buffer stage 1108 that provides signal buffering. Block 1104 forms an oscillator circuit that provides a signal of about 10-12 kilohertz. This signal is used to determine whether an old pressure guide wire 10 or a new pressure guide wire 700 is coupled to the interface circuitry in accordance with the present invention. A synchronous demodulator circuit 1102 takes the oscillating signals and provides a control signal 1106 that is used to control switches 910 and 912 . Switches 910 and 912 remain open when pressure sensor 700 is attached and are closed when pressure wire 10 is attached. The output of demodulator circuit 1102 passes through a two pole 30 Hertz low pass filter stage 1112 having a gain of approximately thirty. FIG. 12 shows a simplified block diagram of the electrical schematics of FIGS. 11 and 12 as interface circuit 1200 . Pressure wire 700 is coupled to connector 1002 that is in turn coupled to the interface switch circuit 1110 comprising the two digital switches 910 and 912 . The output of the digital switches is passed through a buffer stage 1108 prior to being sent to the differential amplifier stage 1008 comprising differential amplifiers 902 and 904 . The output of the differential amplifier stage 1008 is sent to the 2 pole 250 Hertz low pass filter stage 1012 before the signals are sent to console 28 . A reference voltage generator stage 1202 provides the necessary voltages to the circuit. As previously mentioned in order to provide for backward compatibility between the old pressure wire 10 and the new pressure wires 700 , an oscillator 1104 and demodulator 1102 are used to provide a control signal 1106 which either closes switches 910 and 912 or leaves them in the open position. When a new pressure wire 700 is detected, the control signal 1106 leaves the switches 910 and 912 in the open state, while if the old pressure wire 10 is detected control signal 1106 causes the switches to go to the closed state. By using a high frequency (10-12 Kilohertz) signal having low amplitude to make the switching determination between the 3-wire and 5-wire guide wires, prevents any stray noise and interference from affecting the control signal. Also, the use of such a low amplitude-oscillating signal prevents the signal from affecting the measurement of pressure sensor resistors 402 and 404 . A large signal at capacitor C 2 causes control signal 1106 at the output of inverter 114 to be logic high closing the switches 910 and 912 indicating a 3-wire pressure wire 10 is connected to the interface circuit. While a low signal at capacitor C 2 caused by the connection of a 5-wire pressure wire 700 causes the control signal 1106 to be at a low logic level leaving switches 910 and 912 in the open position. The present invention with its use of high input impedance differential amplifiers 902 and 904 to measure pressure sensor resistors 402 and 404 avoids the problem caused by changing contact resistance 922 - 930 . Also, the automatic switching technique disclosed above provides for a system which is backward compatible between pressure guide wires 10 and 700 . While the preferred embodiments of the invention have been illustrated and described, it will be clear that the invention is not so limited. Numerous modifications, changes, variations, substitutions and equivalents will occur to those skilled in the art without departing from the spirit and scope of the present invention as defined by the appended claims. For example, although the preferred embodiment has discussed forming a precision interconnect for a rotating connection, the present invention is not so limited and can be used for non-rotating connections. The present invention can be used for not only with a pressure guide wire it can be used with other devices that need proper measurement of electrical parameters from the device. Also, instead of monitoring a pressure sensor 208 utilizing two resistors 402 and 404 , the present invention can be used to provide a precision interconnect for devices having any number of resistors. If the number of resistors that need to be monitored change, a change has also to be made as to the number of monitoring devices such as differential op-amps 902 and 904 need to be used.

1a

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit of priority under 35 USC §119(e) to U.S. Application No. 61/225,476, filed Jul. 14, 2009 and entitled “Vibrating Fishing Lure”, and which is hereby incorporated by reference in its entirety. FIELD [0002] The present disclosure is related to fishing equipment. More specifically, the present disclosure relates to fishing lures. BACKGROUND [0003] There are a variety of options for fishing lures and bait. Depending on the fish and/or the person fishing, real bait such as worms, small fish, or bugs may be used. Other fish and/or fishermen prefer lures that simulate real bait. Such lures may have a body shape that mimics a bait fish. However, body shape alone is typically insufficient for attracting the desired fish. [0004] Typically, the person fishing will try to make the lure move through the water to mimic a bait fish. However, the success of the mimicry may be limited by the design of the lure, by the skill and knowledge of the user or by other factors. [0005] The information included in this Background section of the specification, including any references cited herein and any description or discussion thereof, is included for technical reference purposes only and is not to be regarded subject matter by which the scope of the invention is to be bound. SUMMARY [0006] Disclosed herein is a fishing lure. In one embodiment, the fishing lure includes a body including a front end, a rear end and a belly portion disposed between the front end and the rear end. The belly portion may include at least a part that has a lateral dimension greater than a lateral dimension of another part of the body longitudinally offset from the part of the belly portion and another part of the body transversely offset from the part of the belly portion. The fishing lure may further include a attachment structure configured to provide a tying point for a line or a connection point for a leader. In various embodiments, the attachment structure may be positioned along a top of the body of the lure, or along a width or a length of the lure, or at a rear end of the lure, or at a front end of the lure. In some embodiments, the fishing lure may further comprise a wire member disposed at least partially in the body of the lure. The body of the fishing lure may be made of a first material and the wire member may be made of a second material. The second material may be more rigid or stronger than the first material. In some embodiments, the wire member is continuous. In some embodiments, the wire member is discontinuous. In some embodiments, the wire member extends over substantially an entire length of the body. [0007] In another embodiment, the fishing lure comprises a body made of a first material and including a front end, a rear end, a top, a bottom and a belly portion disposed between the front end and the rear end, the body defining a longitudinal axis between the front end and the rear end. The lure may also comprise a first connector disposed along the top of the body between the front end and the rear end, the first connector configured to connect with at least one of a fishing line and a leader. The lure may also comprise a second connector disposed at the front end of the body, the second connector configured to connect to a first hook. The lure may also comprise a third connector disposed at the rear end of the body, the third connector configured to connect to a second hook. The lure may also comprise a wire member made of a second material, disposed at least partially in the body and defining the first connector, the second connector and the third connector, the second material being more rigid or stronger than the first material. The belly portion includes at least a part that has a lateral dimension greater than a lateral dimension of another part of the body longitudinally offset from the part of the belly portion in a direction of the front end, greater than a lateral dimension of another part of the body longitudinally offset from the part of the belly portion in a direction of the rear end, greater than a lateral dimension of another part of the body transversely offset from the part of the belly portion in a direction of the top, and greater than a lateral dimension of another part of the body transversely offset from the part of the belly portion in a direction of the bottom, the part of the belly portion disposed between the longitudinal axis and the bottom of the body. In some embodiments, the wire member is continuous. In some embodiments, the wire member is discontinuous. In some embodiments, the wire member extends over substantially an entire length of the body. [0008] This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. While multiple embodiments are disclosed, still other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the invention. As will be realized, the invention is capable of modifications in various aspects, all without departing from the spirit and scope of the present invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive. BRIEF DESCRIPTION OF THE DRAWINGS [0009] FIG. 1 is a side view of an embodiment of a fishing lure. [0010] FIG. 2 is a top view of the fishing lure of FIG. 1 . [0011] FIG. 3 is a top perspective view of the fishing lure of FIG. 1 . [0012] FIG. 4 is a side view of the fishing lure of FIG. 1 illustrating a first embodiment of a wire member. [0013] FIG. 5 is a side view of the fishing lure of FIG. 1 illustrating a second embodiment of a wire member. [0014] FIG. 6 is a side view of the fishing lure of FIG. 1 illustrating a third embodiment of a wire member. DETAILED DESCRIPTION [0015] The present disclosure pertains generally to a fishing lure that is configured to provide action or vibrate as the lure moves through a liquid such as water. In embodiments, the fishing lure may be configured to vibrate as the lure moves vertically through water, in up and/or down directions. In such embodiments, the lure may be configured to vibrate as the lure is dropped in water with a line attached to the lure completely slack and/or with a minimal tension, such as provided by resistance of a spool as the line is unwound therefrom and/or of contact of the line with eyelets of a fishing rod. In embodiments, the lure may be configured to vibrate with different intensity and/or at different frequency with a change in the tension on the line as the lure is dropped in water, such as tensioning the line with a finger of the fisherman on the spool and/or the line. [0016] In embodiments, the lure may be configured to vibrate in up and/or down directions. Such embodiments may be useful for vertical fishing, and particularly useful for ice fishing where control of the lure is restricted by a hole in the ice. [0017] Alternatively or additionally, in embodiments the lure may be configured to vibrate as the lure moves in a direction other than vertical, such as when the lure is cast and reeled in. As such, the lure may be useful for trolling. [0018] In embodiments, the lure may include a means for attaching or attachment structure(s) that may provide a tying point for a line or a connection point for a leader. The attachment structure may be located along a top of the lure. Further, the attachment structure may be positioned along a length and/or along a width of the lure so that the lure is balanced when supported to hang from a line or a leader attached to the attachment structure. In this context, balanced means that a longitudinal axis and/or a lateral axis of the lure is substantially horizontal when so supported. [0019] In embodiments, the lure may have a body that includes a front end, a rear end and a belly portion disposed between the front and rear ends. In embodiments, the belly portion may be disposed between a top and a bottom of the body of the lure. In embodiments, the belly portion may be disposed between a longitudinal axis of the body and the bottom of the body. In embodiments, the belly portion may include the bottom of the body of the lure. [0020] In embodiments, at least a part of the belly portion may have a width or lateral dimension that is greater than a width/lateral dimension of another portion of the body of the lure. In embodiments, the part of the belly portion may have a width or lateral dimension that is greater than that of any other portion of the body of the lure. In embodiments, the part of the belly portion may have a width or lateral dimension that is greater than that of any other portion of the belly. In embodiments, the body of the lure may taper from the part of the belly portion toward the top of the lure, and/or toward the bottom of the lure, and/or the toward the front end of the lure and/or toward the rear end of the lure. [0021] In embodiments, the lure may have a relatively low center of gravity. In embodiments, the center of gravity of the lure may be located below the longitudinal axis of the lure body. In embodiments, the lure may include an attachment structure for attaching the lure to a line or a leader that is located relatively high on the body of the lure. In embodiments, the attachment structure may be located above the longitudinal axis of the lure body. [0022] In embodiments, the lure may include an attachment structure at the front end of the lure body. In embodiments, the lure may include a hook, such as a treble hook, attached to the attachment structures at the front end of the lure body. Alternatively or additionally, the lure may include an attachment structure at the rear end of the lure body. In embodiments, the lure may include a hook, such as a treble hook, attached to the attachment structure at the rear end of the lure body. [0023] In embodiments, the lure may include a wire member disposed at least partially in the body of the lure. In embodiments, the wire member may be of a material that is more rigid and/or stronger than a material of the body of the lure. In such embodiments, the wire member may provide rigidity and/or strength to the lure. In embodiments, the wire member may extend over substantially an entire length of the body of the lure. In embodiments, the wire member may extend along the body near the top of the body. In such embodiments, at least some portions of the wire member disposed in the body of the lure may follow an outer contour of the top of the body. Additionally or alternatively, in embodiments the wire member may extend along the longitudinal axis of the body. Additionally or alternatively, in embodiments the wire member may extend along the body near the bottom of the body. In such embodiments, at least some portions of the wire member disposed in the body of the lure may follow an outer contour of the bottom of the body. [0024] In embodiments, the wire member may be continuous. In other embodiments, the wire member may be discontinuous. In some embodiments, the wire member may define the attachment structure that provides a tying point for a line or a connection point for a leader, and/or the attachment structure at the front end of the lure body, and/or the attachment structure at the rear end of the lure body. [0025] In embodiments, the body of the lure may have a uniform density, excluding the wire member. In embodiments, the body of the lure may be sufficiently dense, or have a sufficient weight, to allow the lure to operate as desired at any depth of water, fresh and/or salt. In embodiments, the body of the lure may be solid. [0026] One embodiment of a lure 10 is shown in FIGS. 1-3 . As depicted, the lure 10 may include a body 12 in a shape that resembles a natural shape of a bait fish typically used for fishing in fresh or salt waters. In particular, the lure 10 may be a jig that is designed to be jerked up and down or drawn through the water. [0027] The body 12 may include a front or head end 14 and a rear or tail end 16 . The ends 14 , 16 may define a length or longitudinal dimension 18 of the body 12 of the lure 10 . The body 12 may also include a top 20 and a bottom 22 . The top 20 and bottom 22 may define a height or transverse dimension 24 of the body 12 of the lure 10 . As shown, the height/transverse dimension 24 of the body 12 may vary over the length/longitudinal dimension 18 . The body 12 may also include a right side 26 and a left side 28 . The right and left sides 26 , 28 may define a width or lateral dimension 30 of the body 12 of the lure 10 . As shown, the width/lateral dimension 30 of the body 12 may vary over the length/longitudinal dimension 18 and/or over the height/transverse dimension 24 of the body 12 . [0028] The lure 10 may include a first attachment structure 32 . The first attachment structure 32 may be configured to provide a tying point for a line L and/or a connection point for a leader L. For example, the first attachment structure 32 may comprise a hole in the body 12 of the lure 10 . As shown, the first attachment structure 32 may be located along the top 20 of the body 12 of the lure 10 . Further, the first attachment structure 32 may be positioned along the length 18 and/or along the width 30 of the body 12 so that the lure 10 is balanced when supported to hang from the line/leader L attached to the first attachment structure 32 . The lure 10 may be balanced such that a longitudinal axis A and/or a lateral axis B of the lure 10 is substantially horizontal when so supported. Further, the lure 10 may be balanced when configured to include one or more hooks, such as described below. [0029] The lure 10 may include a second attachment structure 34 . The second attachment structure 34 may be configured to provide a connection point for a hook, such as a first treble hook 36 . For example, the second attachment structure 34 may comprise a hole in the body 12 of the lure 10 . Alternatively, the second attachment structure 34 may comprise a wire loop extending from the body 12 as shown. The second attachment structure 34 may be located at the front/head end 14 of the body 12 of the lure 10 . [0030] The lure 10 may include a third attachment structure 38 . The third attachment structure 38 may be configured to provide another connection point for a hook, such as a second treble hook 40 . For example, the third attachment structure 38 may comprise a hole in the body 12 of the lure 10 . Alternatively, the third attachment structure 38 may comprise a wire loop extending from the body 12 as shown. The third attachment structure 38 may be located at the rear/tail end 16 of the body 12 of the lure 10 . [0031] In view of the foregoing, it should be understood that one, two or more attachment structures for attaching hooks may be provided on the lure 10 . As such, the lure 10 may include one, two or more hooks of any desired configuration. As described herein, locating the second and third attachment structures 34 , 38 at the front/head and rear/tail ends 14 , 16 , respectively, may help to ensure that a fish will be hooked whether the fish strikes the lure 10 from the front or rear. [0032] The body 12 of the lure 10 may include a belly portion 42 . As shown, the belly portion 42 may be disposed between the front/head end 14 and the rear/tail end 16 . The belly portion 42 may also be disposed between the top 20 and the bottom 22 of the body 12 of the lure 10 . In some embodiments, the belly portion 42 may be disposed between the longitudinal axis A and the bottom 22 . In some embodiments, the belly portion 42 may include part of the bottom 22 . [0033] At least a part 44 of the belly portion 42 may have a greater width/lateral dimension 30 as compared to the width/lateral dimension 30 of another part of the body 12 of the lure 10 . For example, the part 44 of the belly portion 42 may have a greater width/lateral dimension 30 than a head portion 46 and/or a tail portion 48 of the body 12 . [0034] In some embodiments, the part 44 of the belly portion 42 may have a greater width/lateral dimension 30 as compared to other parts of the belly portion 42 . The part 44 of the belly portion 42 may extend longitudinally over a desired length of the belly portion 44 and/or may extend vertically over a desired height of the belly portion 42 . In some embodiments, the part 44 of the belly portion 42 may be disposed between the longitudinal axis A and the bottom 22 of the body 12 of the lure 10 . In some embodiments, the part 44 of the belly portion 42 may include part of the bottom 22 . [0035] As shown in FIGS. 2 and 3 , the body 12 of the lure 10 may taper from the part 44 of the belly portion 42 toward the top 20 , toward the bottom 22 , toward the front end 14 and/or toward the rear end 16 . Such tapering may narrow the width/lateral dimension 30 of the body 12 adjacent to the part 44 of the belly portion 42 . It should be understood that such tapering may be continuous over at least the belly portion 42 . [0036] The configuration of the body 12 of the lure 10 described above may cause the body 12 of the lure 10 to vibrate as the lure 10 moves or is moved through water. In particular, the configuration may cause the body 12 of the lure 10 to vibrate as the lure 10 moves vertically through water, in up and/or down directions. Alternatively or additionally, the configuration may cause the body 12 of the lure 10 to vibrate as the lure 10 moves in other directions through water. In embodiments, the vibrations of the body 12 of the lure 10 may cause waves to propagate through the water over substantial distances. [0037] The configuration may cause the body 12 of the lure 10 to vibrate as such, regardless of the speed at which the lure moves through the water. In particular, the body 12 of the lure 10 may vibrate upon a minimal amount of movement through water such that vibration of the body 12 is substantially instantaneous with movement of the lure 10 through water. The configuration may also cause the body 12 of the lure 10 to vibrate regardless of the weight (diameter) of the line, the leader and/or other tackle attached to the line attached to the lure 10 . [0038] For example, the configuration may cause the body 12 of the lure 10 to vibrate as the lure 10 is dropped into the water, with or without tension on the line connected to the lure 10 . Further, the configuration may cause the body 12 of the lure 10 to vibrate as the lure 10 is moved vertically upward and/or moved horizontally, such as by moving the tip of the fishing rod and/or reeling in the line. Further, the configuration may cause the body 12 of the lure 10 to vibrate more or less in response to an amount of tension applied to the line attached to the lure 10 . [0039] In embodiments, the wider part 44 of the belly portion 44 may generate turbulence in the water on either or both sides of the lure 10 as the lure 10 moves through water. Such turbulence combined with a relatively high attachment point and a relatively low center of gravity may create the action or vibration of the lure 10 . As discussed above, such action may result from any movement of the lure 10 through water, whether dropped by tipping the associated fishing rod or by unreeling the associated line, raised by tipping the associated fishing rod or by reeling in the line, or otherwise moved by the associated rod and/or line. [0040] The configuration of the body 12 of the lure 10 described above may thus facilitate fishing vertically within a “strike zone” where the fish are located, while providing constant or near constant vibrations to attract the fish and cause them to bite. The configuration of the body 12 of the lure 10 described above may also facilitate trolling by reducing snags on plants, rocks, and other underwater obstacles, while providing constant or near constant vibrations. In particular, the wider part 44 of the belly portion 42 of the body 12 of the lure 10 may result in a deflecting effect to help avoid snags on the one or more hooks of the lure 10 . This may be especially true when the hook(s) are located at the front/head end 14 and/or the rear/tail end 16 of the body 12 . [0041] In embodiments, the part 44 , or more, of the belly portion 42 may include reflective and/or iridescent material. Such material may highlight the part 44 and/or the belly portion 42 to attract fish. In some embodiments, the reflective and/or iridescent material of the part 44 , or more, of the belly portion 42 may differ from other parts/portions of the body 12 . [0042] In embodiments, the density and/or weight of the lure 10 may be sufficient to allow the lure 10 to operate at any water depth desired. In particular, embodiments of the lure 10 may be provided in various weights, such as 14 g (½ oz), 21 g (¾ oz), 28 g (1 oz), 42 g (1½ oz), 56 g (2 oz), 84 g (3 oz), 120 g (4 oz) and 120 g (5 oz), this list not being exhaustive. [0043] With reference to FIGS. 4-6 , the lure 10 may include a wire member 50 disposed at least partially in the body 12 . The wire member 50 may be of a material that is more rigid and/or stronger than a material of the body 12 of the lure 10 . In such embodiments, the wire member 50 may provide rigidity and/or strength to the body 12 of the lure 10 . The wire member 50 may extend over substantially an entire length 18 of the body 12 of the lure 10 , as shown in each of the embodiments of FIGS. 4-6 . [0044] In the embodiment shown in FIG. 4 , the wire member 50 may extend longitudinally along the body 12 near the top 20 . At least some portions of the wire member 50 may follow an outer contour of the top 20 of the body 12 as shown. [0045] Additionally or alternatively, in the embodiment shown in FIG. 5 , the wire member 50 may extend along the longitudinal axis A of the body 12 . As shown, this may be in combination with the wire member 50 may extend longitudinally along the body 12 near the top 20 . Thus, the wire portion 50 may include an upper portion 50 a and a lower portion 50 b as depicted in FIG. 5 . [0046] Additionally or alternatively, in the embodiment shown in FIG. 6 , the wire member 50 may extend along the body 12 near the bottom 22 of the body 12 . At least some portions of the wire member 50 may follow an outer contour of the bottom 22 of the body 12 . As shown, this may be in combination with the wire member 50 may extend longitudinally along the body 12 near the top 20 . Thus, the wire portion 50 may include the upper portion 50 a and the lower portion 50 b as depicted in FIG. 6 . [0047] As illustrated by the embodiment of FIG. 4 , the wire member 50 may be discontinuous. As illustrated by the embodiments of FIGS. 5 and 6 , the wire member 50 may be continuous. In some embodiments, the wire member 50 may define the first attachment structure 32 that provides a tying point for a line or a connection point for a leader, the second attachment structure 34 at the front end 14 of the body 12 , and/or the third attachment structure 38 at the rear end 16 of the body 12 . [0048] It should be understood that various features of the embodiments described above may be combined to form yet further embodiments not specifically described. Thus, it should be understood that any of the features described above may or may not be included in embodiments while still embodying aspects of the disclosed invention.

1a

BACKGROUND OF THE INVENTION [0001] The present invention relates to a cosmetic composition for external use containing a carrier, a skin-whitening agent, and sodium magnesium silicate. [0002] Certain skin-whitening agents in cosmetic compositions oxidize over time, causing the cosmetic composition to decompose. The decomposition causes the cosmetic composition to darken and to develop an intense, undesirable odor. Certain skin-whitening ingredients are known to be worse than others for premature oxidation. For example, magnesium ascorbyl phosphate and botanical whiteners such as bearberry extract and others have been especially prone to premature oxidation. For this reason, cosmetic compositions containing these whitening agents tend to decompose, turn brown, and develop a foul odor. As a result, cosmetic compositions containing certain skin-whitening agents have very limited shelf lives. [0003] Nevertheless, skin-whitening compositions are still in high demand, especially in Asian markets. For this reason, a method is needed to slow the decomposition of skin-whitening compositions and the resulting darkening and foul odor of the skin-whitening compositions. Surprisingly, adding sodium magnesium silicate to skin-whitening compositions dramatically slows the darkening of these compositions as well as the development of the undesirable odor. Accordingly, cosmetic compositions that contain skin-whitening agents susceptible to oxidation have longer shelf lives if those cosmetic compositions also contain sodium magnesium silicate. SUMMARY OF THE INVENTION [0004] In one aspect of the invention, a composition for topical use that has a melanin synthesis-inhibiting activity is provided. The composition comprises a carrier, a skin-whitening agent, and sodium magnesium silicate, wherein the sodium magnesium silicate is present in an amount effective to slow decomposition of the composition. [0005] In another aspect of the invention, an improvement in a skin-whitening composition comprises an effective amount of sodium magnesium silicate to slow the decomposition of the composition. [0006] In still another aspect of the invention, a method of slowing the decomposition of a cosmetic composition containing a skin-whitening agent comprises adding an effective amount of a sodium magnesium silicate to the composition. [0007] It is noted that, unless otherwise stated, all percentages given in this specification and the appended claims refer to percentages by weight. [0008] The present invention provides the foregoing and other features, and the advantages of the invention will become further apparent from the following detailed description of the presently preferred embodiments. The detailed description is merely illustrative of the invention and does not limit the scope of the invention, which is defined by the appended claims and equivalents thereof. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0009] In accordance with the present invention, a skin-whitening cosmetic composition is provided that comprises a carrier, a skin-whitening agent, and sodium magnesium silicate. The present invention also concerns preventing the premature oxidation of skin-whitening agents in cosmetic compositions, which causes the compositions to brown and to develop an odor over time. [0010] Certain skin-whitening agents are especially prone to premature oxidation. These skin-whitening agents include, but are not limited to, magnesium ascorbyl phosphate and botanical extracts such as bearberry extract, lemon extract, cucumber extract, mulberry extract, licorice extract. [0011] The cosmetic composition may contain other skin-whitening agents, whether or not those agents are prone to premature oxidation. Such skin-whitening agents may include all the known whitening agents and those that may be developed in the future. Although it is not possible to identify and list all known skin-whitening agents, the following skin-whitening agents may be included in the cosmetic composition of the present invention: tyrosinase inhibitors, free radical scavengers, chelating agents, and mixtures thereof. [0012] Some tyrosinase inhibitors include, but are not limited to, arbutin, bearberry extract, orange extract, lemon extract, cucumber extract, mercaptosuccinic acid, mercaptodextran, kojic acid, derivatives of kojic acid, vitamin C, derivatives of vitamin C, hydroquinone and derivatives of hydroquinone, glutathione, cysteine and its derivatives such as N-acetyl-L-cysteine and those described in U.S. Pat. No. 5,296,500, the relevant portions of which are incorporated herein by reference, mulberry extract and its derivatives, licorice extract and its derivatives, rosemary extract and its derivatives, and mixtures thereof. [0013] The kojic acid or its esters are represented by the formula: [0014] wherein R 1 and R 2 are the same or different, and each is hydrogen atom or an acyl group of 3 to 20 carbon atoms. [0015] Non-exclusive examples of the esters are, for instance, kojic acid monoesters such as kojic acid monobutyrate, kojic acid monocaprate, kojic acid monopalmitate, kojic acid monostearate, kojic acid monocinnamoate and kojic acid monobenzoate; kojic acid diesters such as kojic acid dibutyrate, kojic acid dipalmitate, kojic acid distearate and kojic acid dioleate. A preferred monoester is an ester in which an OH group at 5-position of kojic acid is esterified. Esterification can improve stabilities against pH or sun light, while maintaining a melanin synthesis-inhibiting activity equal to that of kojic acid. [0016] The free radical scavengers may include, but are not limited to ascorbic acid (vitamin C) and its derivatives, vitamin E, superoxide dismutase, acerola cherry extracts, acerola cherry fermentates [0017] The vitamin C and its derivatives may be present in any isomeric form. For example, they can all be in cis configurations, they can all be in trans configurations, or they can be in a mixture of cis and trans configurations. [0018] Non-exclusive examples of the vitamin C derivatives are, for instance, the alkyl esters of L-ascorbic acid where the alkyl portion has from 8 to 20 carbon atoms. For example, such esters include, but are not limited to L-ascorbyl palmitate, L-ascorbyl isopalmitate, L-ascorbyl dipalmitate, L-ascorbyl isostearate, L-ascorbyl distearate, L-ascorbyl diisostearate, L-ascorbyl myristate, L-ascorbyl isomyristate, L-ascorbyl 2-ethylhexanoate, L-ascorbyl di-2-ethylhexanoate, L-ascorbyl oleate and L-ascorbyl dioleate, tetrahexyl decyl ascorbate; phosphates of L-ascorbic acid such as L-ascorbyl-2-phosphate and L-ascorbyl-3-phosphate; sulfates of L-ascorbic acid such as L-ascorbyl-2-sulfate and L-acorbyl-3-sulfate; their salts with alkaline earth metals such as calcium and magnesium. A preferred whitener is magnesium ascorbyl phosphate. The vitamin C derivatives can be used alone or in a mixture of two or more. [0019] Other skin-whitening agents may include gingko extract, carob extract, rose fruit extract, geranium herb extract, Perilla extract, cinnamon extract, sweet marjoram extract, Arnica extract, Concha Blanca extract, cola ed Caballo, Piri-Piri, Pinon Negro, Pinon Blanco, extracts of clove, alfalfa, Baliospermum montanum, Melia azadirachta, convolvulus arvensis, Gaiyo, Sansonin, Syuroyo, Seimkko, Soukyo, Taiso, Hakusempi, Woodfordia fructosa, Lagerstroemia speciosa, passiflorine, tepezcohite, amoule, Hobiyu, Baffalo Uri, Achote, Guayule, Adhatoda, Cymbopogon nardus, Desmodium gangeticum, Murraya koenigii, Smilax zeylanica, Gastrodia elata, Karukeija, Biota orientalis, Kichiascoporia, Arecatachu, Phyllostachys Nigra leaves, Atractylodes japonica, Koidzumi, Tila, Camotede Azafran, Jamaica, Poleo verde, Navo negro, Cyperus, Kanzo, Broussonetia, Karojitsu, Trichosanthis Radix, Dioscorea Phizoma, and Aquilliaria. [0020] Other skin-whitening agents may include teprenone, dihydroxy-isoquinoline, indomethacin, 3-hydroxymanule, vitamin K (such as vitamin K1-K7, its homologues, salts, and derivatives), thiazolidinone derivatives, and kynurenine and its derivatives and salts. [0021] The skin-whitening agent may be used in the cosmetic composition of the present invention in an amount of from about 0.001% to about 99%. Preferably, the skin-whitening agent is present in the composition in an amount of from about 0.01% to about 20%. More preferably, the amount ranges from about 0.1% to about 10%. [0022] Sodium magnesium silicate is commercially available under the trade name LAPONITE. It is a synthetic silicate clay with a composition mainly of magnesium and sodium silicate. [0023] Surprisingly, sodium magnesium silicate has the unexpected and beneficial effect of reducing the time and temperature-induced darkening effect of the skin-whitening agent in the cosmetic composition. In other words, sodium magnesium silicate prevents the premature darkening of the cosmetic composition. The results are especially impressive when the cosmetic composition includes skin-whitening agents prone to oxidation such as magnesium ascorbyl phosphate and botanical extracts. [0024] Surprisingly, sodium magnesium silicate also improves the odor of the composition by reducing the time and temperature-induced development of foul odors as the skin-whitening agents oxidize. In other words, sodium magnesium silicate prevents the premature development of a foul odor. The results are especially impressive when the cosmetic composition includes skin-whitening agents prone to oxidation such as magnesium ascorbyl phosphate and botanical extracts. [0025] Sodium magnesium silicate may be used in the whitening composition in an amount from about 0.001% to about 99%. Preferably, sodium magnesium silicate is present in the composition in an amount of from about 0.01% to about 10%. More preferably, the amount ranges from about 0.1% to about 5%. [0026] The cosmetic compositions of the present invention may be prepared in various forms. For example, they may be in the form of a cosmetic preparation such as an emulsion, liniment or ointment lotions, creams, (both oil-in-water, water-in-oil, and multiple phase), solutions, suspensions (anhydrous and water based), anhydrous products (both oil and glycol based), gels, sticks, surfactant systems (cleansers, shampoos, facial washes, etc.), powders, masks, pack or powder, or the like. [0027] The cosmetic compositions of the present invention generally include a cosmetically acceptable or pharmaceutically acceptable carrier. The terms “pharmaceutically acceptable” and “cosmetically acceptable” means those drugs, medicaments, or inert ingredients which are suitable for use in contact with the tissues of humans and lower animals without undue toxicity, incompatibility, instability, irritation, and the like, commensurate with a reasonable benefit/risk ratio. [0028] The carrier usually forms from about 1% to about 99.9%, preferably from about 50% to about 99% by weight of the composition, and can, in the absence of other cosmetic adjuncts, form the balance of the composition. [0029] Other optional ingredients can be included in the cosmetic composition of the present invention. As a non-limiting illustration, the optional ingredients can include UV absorbers, fragrances, preservatives, thickeners, ph adjusters, etc, so long as they do not interfere with the function of the skin-whitening agent and the sodium magnesium silicate. EXAMPLES [0030] Following are examples of compositions made according to the present invention. The examples are merely illustrative; they are not limiting. [0031] Each example was compared with a “control” cosmetic composition that had all the same ingredients as the example except for sodium magnesium silicate. The cosmetic composition of each example was then qualitatively compared to its control cosmetic composition after exposure to the same conditions. Example 1 [0032] [0032] Ingredient Weight Percent Laponite XLG (Sodium Magnesium Silicate) 0.50 Magnesium Ascorbyl Phosphate 3.00 Botanical whitening complex 1.00 Water and Optional Ingredients q.s. [0033] The composition of Example 1 was qualitatively compared to its control composition after 30 days at 50° C. The control composition decomposed, changed its color to brown, and began developing a foul odor, as expected. Surprisingly, the composition of Example 1 maintained its pleasant odor and appearance. Example 2 [0034] [0034] Ingredient Weight Percent Laponite XLG (Sodium Magnesium Silicate) 1.00 Bearberry Extract 2.00 Lactic Acid 2.00 Acerola Fermentate 3.00 Water and Optional Ingredients q.s. [0035] The composition of Example 2 was qualitatively compared to its control composition after 30 days at 50° C. The control composition decomposed, changed its color to brown, and began developing a foul odor, as expected. Surprisingly, the composition of Example 2 maintained its pleasant odor and appearance. Example 3 [0036] [0036] Ingredient Weight Percent Laponite XLG (Sodium Magnesium Silicate) 1.00 Magnesium Ascorbyl Phosphate 3.00 Vitamin E 0.05 Water and Optional Ingredients q.s. [0037] The composition of Example 3 was qualitatively compared to its control composition after 30 days at 50° C. The control composition decomposed, changed its color to brown, and began developing a foul odor, as expected. Surprisingly, the composition of Example 3 maintained its pleasant odor and appearance. [0038] Based on the above results, the addition of magnesium ascorbyl phosphate to a cosmetic composition containing a skin-whitening agent prone to premature oxidation will extend the shelf life of that cosmetic composition. Magnesium ascorbyl phosphate may extend the shelf life of the cosmetic by as much as 25%, preferably by as much as 50%, more preferably by as much as 100%, or most preferably by as much as 200%. [0039] It should be understood that a wide range of changes and modifications could be made to the embodiments described above. It is therefore intended that the foregoing description illustrates rather than limits this invention, and that it is the following claims, including all equivalents, which define this invention.

1a

BACKGROUND OF THE INVENTION [0001] Minimization of the time between injury occurrence and transport to the appropriate level of medical care is necessary to ensure that wounded and sick soldiers obtain the prompt medical attention essential for their survival. During that time, aeromedical care in a MEDEVAC helicopter environment is used to identify and transport casualties. [0002] Military units conduct aeromedical evacuations daily during times of war and peace, exposing the patient and flight/medical crew to noise or environmental stress and difficult monitoring conditions. As in the civilian community, military nurses depend on reliable and efficient monitoring devices to provide accurate patient care in various environments, some of which are hostile and obtrusive to the use of conventional monitoring instrumentation. While aeromedical evacuation is a life-saving process for many, it is nearly impossible for medical personnel to monitor vital signs in a high noise environment. [0003] Vital signs monitoring is normally a simple and routine procedure involving collection of pulse, respiration and blood pressure data. In a relatively quiet environment, these parameters are easily detected. However, acquisition of physiological signals of interest in a helicopter environment is a challenging problem for several reasons. Limitations on vital signs collection include high noise, vibration, auditory distractions, ineffective monitoring equipment, cramped working conditions, bulky gear during air evacuation, and electromagnetic interference with aircraft systems caused by some medical equipment. The additional complexity of leads and electrodes compounds the noise and environmental problems. The physiological parameters of vital signs fall within the helicopter-generated frequencies. Helicopter frequencies have a much greater power in those frequencies as well. Vibrational and acoustic artifacts are also major problems. The signal to noise problem must therefore be solved by other means in addition to low and high band pass filtering approaches. Due to the limiting work conditions, medical personnel cannot use a stethoscope to accurately monitor heart activity or blood pressure. [0004] The military medical system needs a portable, non-invasive device capable of monitoring a soldier's vital signs in the field environment under less than ideal circumstances. This system needs to be useful to military medical personnel across the spectrum of care delivery, such as in-mass casualty situations, aeromedical evacuations, ground ambulance transports, hospital wards, and intensive care units. A recent study found that thirty-two percent of aircraft medical devices flown onboard a rotor-wing MEDEVAC aircraft failed at least one environmental test. [0005] Quartz crystals are minerals that create an electric field known as piezoelectricity when pressure is applied. Materials scientists have found other materials with piezoelectric properties. The versatility and potential uses for piezoelectric materials have been known but cost-prohibitive for some time. [0006] However, recent decreases in the cost of manufacturing now permit greater application by engineers and researchers. The advantageous qualities of piezoelectric materials have been applied to medicine, security, acoustics, defense, geology and other fields. Development of applications with piezoelectric materials is in its infancy. [0007] The medical practice and research application of piezoelectric-based instrumentation is gaining momentum. Piezoelectric methods have been successfully used in plethysmography, blood pressure monitoring by piezoelectric contact microphone, heart rate monitoring in avian embryos and hatchlings and piezoelectric probes. Piezoelectric materials are used as detectors of sensitive motion to measure human tremor, small body movements of animals in response to pharmacological manipulation, and respiratory motion for nuclear magnetic resonance (NMR) animal experiments. In combination with ultrasound, piezoelectric methods have been used to assess coronary hemodynamics, elastic tensor, intra-arterial imaging, and receptor field dimensions. In addition, piezoelectric transducers have been attached to the chest wall and used with automated auscultation devices and microcomputers for lung sound analysis. Piezoelectric film has been applied and studied to determine joint contact stress, and piezoelectric disks have been used for recording muscle sounds and qualitative monitoring of the neuromuscular block. [0008] Stochastic wave theory, as commonly used in ocean engineering to analyze pseudo-periodic phenomena, indicates spectral peaks from respiration and heart rate. Human heartbeats, respiration, and blood pressure are repetitive in nature, reflecting complex mechano-acoustical events. However, various problems with piezoelectric instrumentation development prevent its full realization. Measurement of human tremor only works well when the environment is absolutely silent. In fact, extraneous noise such as equipment, fans, people talking, and the patient's own voice routinely exists in most hospital rooms. That noise masks and distorts the signal of interest, thus limiting the practicality of piezoelectric instrumentation. Animal noises make data collection difficult in laboratory animal studies. In non-laboratory environments, medical uses of piezoelectric instrumentation for humans remains a problem because of the inherent signal-noise problem. [0009] A primary mission of military nurses is to ensure that wounded and sick soldiers obtain prompt medical attention and/or evacuation to definitive medical care. The actions performed during the time period between a battlefield injury and the transfer of casualties to appropriate medical treatment is critical for the welfare of the soldier, and can be the difference between life and death. It is during this critical time period where diagnosis and treatment begins and also when evacuation—for example via MEDEVAC helicopter—occurs. [0010] Unfortunately, the extremely high noise and vibration inherent in the helicopter environment prevents nursing and medical personnel from accurately measuring vital signs. Not only are electronic medical monitors rendered ineffective with the high vibrations; traditional methods of measuring pulse and blood pressure using a stethoscope become unreliable in the high noise. Cramped working conditions and bulky gear during air evacuation exacerbate these problems. [0011] Most conventional methods use devices that employ electrodes, leads, wires, and cuffs to measure one or more vital signs, for example, blood pressure machine, ECG monitor, pulse oximeter. Existing monitors require some sort of attachment and thus are not passive. In addition, conventional equipment is highly sensitive to noise, such as a helicopter or airplane engines and rotors. [0012] Clearly, what is needed for this common situation is a monitor that can consistently and accurately measure vital signs during a medical evacuation where there is high noise and vibration. The monitor being relatively autonomous intervention by a nurse or technician is not required. With the added capability of telemetry for remote monitoring and communication, information may be forwarded in real-time via wireless communication to the destination where medical personnel and other caregivers are located. [0013] Needs exist to develop better methods and apparatus for physiological monitoring. SUMMARY OF THE INVENTION [0014] The present invention is known as Passive Physiological Monitoring, P 2 M, or simply P2M. Data records with vast information, such as blood pressure, are measured, recorded, and may later be delineated to determine the physical condition of the subject being monitored. [0015] Recent developments in materials science and data processing have created the potential for a new monitoring device using piezoelectric film, an electrically active fluoropolymer. Although the medical applications of piezoelectric film are still at the infant stage, the testing of medical instruments is promising. [0016] The cardiovascular system is modeled as a system of pipes, pumps, and other appendices, with the engineering phenomenon known as “water hammer” as the basis for a working model for data analysis in the calculation of blood pressure. [0017] “Water hammer” is a compression wave transmitted through the household plumbing network of pipes and valves when household water is abruptly shut off. The result is a noticeable sound and the deterioration of the plumbing system. Water hammer is caused by the increase in pipe pressure caused by sudden velocity change, typically after water is shut off during a valve closing. The compression wave is described as follows: c = 1 ρ * ⅆ P ⅆ V ( 1 ) [0018] where [0019] c=speed of the compression wave (ft/sec); [0020] dV=change in velocity (V initial −V final ); [0021] ρ=density of the fluid; and [0022] dP=change in pressure. [0023] Skalak (1966) applied the linearized theory of viscous flow to develop a basis for understanding the main waveform features in arteries and veins. The vascular system is equivalent to a network of non-uniform transmission lines. [0024] Womersly (1957) had applied those principles to a single uniform tube representing an arterial segment and compared the results to the experimental data taken in a dog, prior to Skalak's theory. Good agreement was reported between the measured flow and the flow computed from the measured pressure gradient. [0025] Anliker (1968) showed that the dispersion phenomena associated with waves propagating in blood vessels are potential measures of the distubility of the vessels and other cardiac parameters. Anliker assumed that vessels behave like thin-walled cylindrical shells filled with inviscid compressible fluid. More complete models have provided good agreement. [0026] Karr (1982) studied pressure wave velocity on human subjects and developed a method to determine the pulse propagation speed. The invention recognizes that such information may be used to determine plaque buildup, cholesterol concentration on the arterial wall, and arterial wall thickness. [0027] Equation (1) allows for determination of pressure change (dP) from the heart pulsing based on the dispersion relationship between pulse wave velocity (c) and flow velocity (v). Karr's method measures flow velocity to determine dP, which is related to systolic pressure (pS) and diastolic pressure (pD). [0028] The new invention measures the pressure energy from heartbeat and respiration collectively. The heart contribution to the energy spectrum is determined by removing the respiration contribution to the energy spectrum. Respiration energy is filtered out by comparing the energy spectrum calculations of velocity with velocity measures using electromagnetic and doppler methods. Since the sympathetic tone may influence blood pressure measurement accuracy, the new monitor can be configured for one of its piezoelectric sensors to serve as a dedicated doppler sensor that uses ultrasonics to adjust interpretations of data as a function of the sympathetic tone of the patient. The selective omission of P2M signals and the selective comparison of P2M sensor data with data from other parts of the body, as well as comparisons between two or more simultaneously triggered sensors, isolates energy contributions from the heart. P2M energy spectra determined from the foot differs from spectra derived from the chest area, which provides a means for isolating heart energy as the foot spectra is largely void of energy from respiration. [0029] Once velocity (v) is known, the relation between systolic and diastolic blood pressure (2) and the Bernoulli equation (3) is used to measure blood pressure. The Bernoulli equation is a fundamental relationship in fluid mechanics that is derived from Newtonian mechanics and the principle of conservation of energy. A more compressive version of the same equation can be developed to reflect more complicated non-steady flows. p = pD + 1 3 * ( pS + pD ) ( 2 ) [0030] where [0031] pS=systolic pressure; [0032] pD=diastolic pressure; and [0033] p=average pressure. p=ρgh+ ½ *ρ*V 2   (3) [0034] where [0035] ρ=fluid density, [0036] g=gravitational constant, and [0037] h=height, head energy term. [0038] From these equations we can develop expressions for pD and pS, both as a function of the pulse wave velocity (c), flow velocity (v) and pulse wave pressure (dP): pD= ½ *ρ*v 2 −ρ*C*dV   (4) pS=pD+ρ*C*dv   (5) [0039] P2M is well-suited to assist medical personnel in several areas including, but not limited to, the following situations: [0040] (1) Medical monitoring of vital signs of severely injured persons in high noise and vibration environments such as rescue helicopter where current monitoring techniques are cumbersome or impossible; [0041] (2) Monitoring casualties resulting from major disasters such as aircraft accidents, earthquakes and floods; [0042] (3) Physiological monitoring of large numbers of patients through a “smart stretcher” easily deployed for field use by medical personnel; [0043] (4) Continuous military hospital bed monitoring without disturbing patients; and [0044] (5) Patient monitoring when treatment is delayed due to temporary overload of medical facilities. [0045] The development of the P2M or a passive sensor array (multi-sensor system) is a significant innovation in passive monitoring. Through the use of a grid of passive sensors, noise can be reduced through correlating signals from different pads to discern noise from biological signals. This is very important in high-noise environments. Additionally, the significance of a passive multi-sensor system is that it affords the opportunity to more comprehensively monitor a patient. As a tool, the grid of passive sensors provides an innovative way to monitor patients in adverse ambient conditions. The system provides a tool whereby parameters other than blood pressure, heart rate, and respiration can be measured. These parameters include, but are not limited to, patient movement and sleep habits, pulse strength over various portions of the body, relative blood flow volumes, and cardiac output, among others. [0046] The main components of the Passive Physiological (P 2 M) system are the passive sensor, hardware for amplification, filtering, data-acquisition, and signal-analysis software. In a preferred embodiment, the single passive sensor has dimensions 8″×10″ and is preferably encased in a protective covering. Leads from the sensor attach to the electronics (amplifier, filter, data-acquisition card, desktop computer) where the raw analog voltage signal is filtered and amplified and converted to digital form. Digital filtering and software manipulation of the data in the form of frequency analyses are then performed. Finally, signal processing techniques are then used to extract physiological information from the digital signal. [0047] The sensor pad is preferably placed directly beneath the back of a patient lying supine on a MEDEVAC litter. The mechanical/acoustic signals created by cardio-pulmonary function are transmitted through the body onto the passive sensor, which converts the signal into an analog voltage. An illustration of the existing P2M setup is shown in FIG. 6 . Among the major hardware used for the laboratory setup are: desktop computer, a multi-function programmable charge amplifier and roll-around rack to encase all of the hardware. To maintain versatility for initial research and development, most of the equipment were chosen for functionality at the expense of space efficiency. [0048] It is an object of the present invention to provide the military medical community with an inexpensive, non-restrictive, portable, light-weight, accurate, and reliable device that can be used in field or fixed facilities to provide an accurate measurement of heart rate, respiration and blood pressure in high noise and vibration environments and thus improve medical care in mass casualty situations, aeromedical evacuations and hospital settings. [0049] It is an object of the present invention to adjust the signal noise to enable the use of piezoelectric instruments in aeromedical transport of patients, hospital bed monitoring, and other applications in the military and civilian medical environment. [0050] It is an object of the present invention to develop a prototype physiological monitor using piezoelectric film in various field environments. The variables of accuracy, precision, user characteristics, and patient comfort determine the value of a field instrument for collection data on vital signs. [0051] It is an object of the present invention to provide a non-invasive means for monitoring vital functions without the use of electrical leads or wiring on the patient. The use of the human body's acoustic and electromagnetic signals to determine heart rate, respirations, and blood pressure. [0052] These and further and other objects and features of the invention are apparent in the disclosure, which includes the above and ongoing written specification, with the claims and the drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0053] FIG. 1 is a schematic of the P2M system components. [0054] FIG. 2 is a perspective view of the P2M system. [0055] FIG. 3 is a graphical comparison of the P2M bench test results and the human evaluator measurements. [0056] FIG. 4 is a front view of the front panel display and user interface of the P2M system in Acquire Mode. [0057] FIG. 5 is a front view of the front panel display of the P2M system in Monitor Mode. [0058] FIG. 6 is a schematic view of a preferred embodiment of the P2M sensor. [0059] FIG. 7 shows one of the graphical user interfaces (GUI) of the P2M system. [0060] FIG. 8 shows the graphical user interface of the P2M system showing time-series and frequency-domain representations of physiological data. [0061] FIG. 9 shows measurement of Pulse-Wave Travel Time (PWTT) FIG. 10 shows a system test and evaluation results in a graph. [0062] FIG. 11 high noise and vibration testing of the P2M at Wheeler Army Air Field. [0063] FIG. 12 shows the measurement through a body armor. [0064] FIG. 13 shows testing through body armor and MOPP gear combined. [0065] FIG. 14 shows a schematic view of the Passive Physiological Monitoring (P2M) System Using a passive sensor array and microelectronics incorporated into a MEDEVAC litter. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS [0066] The preferred P2M system is a monitoring device with two major subsystems, one to measure signals and the other to process data into meaningful information. [0067] FIG. 1 shows a schematic of the system, and FIG. 2 shows a perspective view of the system. First, the piezoelectric film, an electrically active fluoropolymer converts mechanical energy such as movement caused by a heartbeat into voltage measurements capable of supporting time series analysis techniques. Second, the voltage is recorded by and analyzed using a microcomputer controlled system, the purpose of which is to discriminate the signal from background noise and display it on a screen or printout. Techniques such as preamplifying and preconditioning through the use of high and low-band pass filters reduces noise. [0068] The piezoelectric material 1 used is the polymer polyvinylidene fluoride (PVDF), which can be shaped into cables, thin film, or thick tiles. PVDF piezoelectric film is environmentally rugged, lightweight, flexible, inherently reliable, sturdy, easily repairable and transportable with excessive assembly or disassembly. Since the material is inert, it may be used inside the human body. Ultraviolet radiation passes harmlessly through the PVDF film, which may be produced in varying thicknesses. In addition, the piezoelectric film is waterproof, operates between 0 and 145 degrees Centigrade, and does not tear under stress. PVDF may convert a temperature reading into an electric output. The PVDF film is incorporated into a fluid-filled vinyl pad, approximately 10 cm by 10 cm in surface area. This is placed on/under/above various locations of the patient. [0069] P2M detects cardiac and respiratory motion, and monitors pulse, respiration and apnea episodes 3 . Cardiac and respiratory movements are simultaneously recorded by selective filtering of original signal. The piezoelectric element 1 is a pressure—sensing detector acting as a highly sensitive strain gage providing high dynamic range and linearity. Analog signals are fed through a band-pass filter into an amplifier (×200-×5000) 5 and are visually displayed. Analog acoustic signals are converted to digital values using a multi-channel converter 7 at a sampling rate of up to 5 kHz. Data is transformed to the frequency domain using Fast Fourier Transform (FFT). The system uses a microcomputer 9 for recording, analysis and presentation of data, which allows for on-line assessment of data and realtime decisions. [0070] In its simplest mode of operation PVDF piezoelectric film 1 acts as a piezoelectric strain gage. The voltage output is up to four orders of magnitude higher than that produced by a nonamplified signal from circuitry used with resistive wire. Linearity and frequency response are excellent. Although similarities to a strain gage exist, current need not be applied since the device is electrically self-generating. Unlike the strain gage, the present invention does not produce an electric charge ad infinitum with sustained stress. The slowest frequency the polymer film detects is a thousand seconds for an electrical event to occur, and the highest is one gigahertz (microwave). The piezoelectric film is passive and biologically non-hazardous, as opposed to traditional strain gages that require an applied current. [0071] PVDF sheets are commercial off-the-shelf (COTS) products, the type and specifications of which were chosen based on optimum sensitivity range and resilience. Each sheet contains seven-foot attached shielded twisted-pair (for noise rejection) leads 11 to transmit the charge produced by the sheets. [0072] The piezoelectric sheets 1 are placed under a patient's chest and foot or at similarly remote areas of the body, or may be put on like a wrapped cuff. The change in pressure exerted by the patient's respiration and heartbeat causes the piezoelectric film to generate voltages, which is carried via nonmagnetic miniature coaxial cable 11 through a radio frequency filter 13 . The signal is then directed to a high input-impedance amplifier 5 and computer system 7 for data processing. A conventional oscilloscope and a chart recorder displays the output. Respiration and heart rate 15 are then calculated by the energy spectrum from the time series data. [0073] Several techniques reduce noise and vibration interferences. Active cancellation uses two piezoelectric sensors, one of which is not in contact with the body. The sensor not attached to the body is exposed to environmentally acoustic and vibrational signals, while the sensor attached to the body is exposed to environmental as well as body signals. Subtraction of one output from the other output yields the body signal of interest. [0074] Another preferred technique to reduce noise involves band-pass filtering/band-stop filtering. By identifying the extraneous electronic or acoustic noise and its particular frequencies, band-pass or band-stop filtering eliminates extraneous signals from the overall signal. [0075] Additionally, signal processing techniques that use a prior knowledge of the expected signals extract the desired information from the piezoelectric signal. Spectral techniques help to identify the frequencies and amplitudes of the events of interest and discern them from extraneous noise. [0076] Cardiac action analysis uses a bandpass frequency limit of 0.1-4.0 Hz, and respiration analysis uses a frequency limit from 0.01-3.0 Hz. The filtered cardiac and respiration signals are fed to a recording system. Body movements are analyzed by bandpass filtering the original signal with frequency limits from 0.1-20 Hz. [0077] Once the signal produced by the film sensor is converted to voltages, amplified and filtered, it is processed through the P2M instrumentation. The hardware equipment includes, but is not limited to, a 586 processor computer 9 with enhanced RAM and disk capacity to handle large amounts of data. A board with a range that includes acoustic frequencies facilitates data acquisition, signal conditioning and signal processing. [0078] For system operation, a master program 17 combines the three separate software modules of data acquisition/control, signal processing/analysis, and data display/user interface. The LabVIEW™ “G” graphical programming language was used for all three subroutine programs. The analog voltage signal is digitized and analyzed in time and frequency domains. Routines developed for signal conditioning and analysis include digital filtering, spectral analysis, auto correlation, and noise—rejection programs. The data is displayed real-time in either Monitor or Acquisition mode. Monitor mode displays the current data and discards old readings as new updates are processed, while Acquisition mode saves data for future analysis. The voluminous data must not exceed the disk-storage capacity of the computer in Acquisition mode. [0079] For protection and ease of transport, the entire P2M system 19 is encased in a metal technical enclosure 21 with casters (not shown) and locking glass door (not shown), as shown in FIG. 2 . The equipment also includes a MEDEVAC stretcher 23 on which the sensor is mounted. This device may be incorporated into a litter to eliminate the need for patient attachment or miniaturized as a portable field device in a purse with a wireless communication setup. [0080] Significant field and analysis testing was conducted to confirm the workability and accuracy of the P2M system. The piezoelectric film measures mechanical, thermal and acoustic signals. That high sensitivity is necessary to measure vital signals non-intrusively. For pulse rate, the physical beating of the heart is transmitted through the body into the piezo-film sensor pad as mechanical impulses. The respiration is measured by the mechanical impulse transmitted to the sensor based on chest movements. The sensitive piezo-film sensor pad measures all extraneous movement and speech, resulting in a voltage signal output that is superimposed upon the physiological signals. As a result, movement or speech by the subject may cause a reading error. [0081] The P2M sensor measures all physical impulses in the measuring environment, including the patient's physiological signals, nearby human noise and activity signals, noise and vibration from the machinery, and electromagnetic (EM) noise emitted from the lights and instrumentation. While the output signal includes all of these signals, many are too weak to affect the measurement while others such as EM noise corrupt the reading. Running the signal through filters and other signal—processing algorithms removes the noise. The conditioned signal is then analyzed through routines, including a fast Fourier transform (FFT) which identifies the primary signal frequencies. For a still, speechless patient, the primary frequency is usually respiration, and the second highest frequency is heart rate. Patient positioning and frequency harmonics may complicate the distinction, requiring additional logic to separate and identify the heart and respiration frequency peaks. The logic algorithms must be robust enough to define the respiration and heart peaks for a variety of conditions. [0082] To increase resolution, a large number of high sampling rate data points were selected and re-sampled at a lower rate to simplify computation for accurate analysis. The minimum sampling interval was thirty seconds. [0083] FIG. 3 shows the results for the twenty respiration/pulse-rate measurements performed with the P2M system. Human evaluator measurements were performed simultaneously as a control. P2M accurately measured pulse 25 and respiration 27 under ideal conditions, but patient movement or speech interfered with accurate measurement. Heart rate measurement quality was not reduced by the absence of respiration, and P2M matched the control measurement results 29 , 31 with an error of less than beat per minute. [0084] FIG. 4 shows the P2M front panel in Acquisition mode. The upper graph 33 displays a thirty-second window of time-series measurements of all physiological signals. Heartbeat spikes are shown in the upper (time series) graph 33 , along with a lower-frequency sinusoidal function which corresponds to the respiration signal. The lower graph 35 shows the same data in the frequency domain. The first and largest spike 37 corresponds to approximately 16.4 respirations per minute. The control group 31 measured 17±2 respirations per minute. The large amplitude of the spike indicates that respiration is the largest impulse measured by the sensor pad. The second-largest spike 39 is sixty times per minute, which was identical to the actual heart rate measured by a fingertip-clip heart-rate monitor. The power as measured by the amplitude is less than one-third of that found in the respiration frequency, but the ratio varies based on the physiology and sensor pad positioning of the patient. The smaller spikes 41 in the lower graph represent respiration and heart-rate harmonics, a result of the harmonics not being a perfect sinusoidal function. Since the heart rate might fall at exactly the same frequency as a respiration harmonic, it is necessary for logic algorithms to check for harmonics. The heart rate and respiration harmonics may be differentiated by comparing signals taken from different parts of the body. [0085] The buttons and menus 43 on the front panel of the interface program enables the control of data acquisition and analysis routines. The thirty-second data records may be saved to file for archiving or additional evaluation. [0086] FIG. 5 shows the P2M system in Monitor mode. The top graph 45 shows the time-series data, with the characteristic higher-frequency heartbeat spikes 47 superimposed over a lower—frequency respiration wave 49 . The middle graph 51 shows heart rate 53 and respiration 55 as updated every five seconds. As a new five-second data string is acquired, the oldest five seconds of data is discarded, and the heart rate and respiration are re-calculated by analyzing the thirty-second data string with the new data. The upper curve 53 is colored red to signify heart rate, while the lower curve 55 is colored blue to signify respiration. Heart rate appears steady in the mid-50s range, with respiration in the mid-teens. Both compare favorably (±2) with human control measurements. The anomaly 57 after 25 updates is attributable to patient movement or an extraneous and errant noise/vibration event. The bottom graph 59 shows an FFT of the time-series signal. [0087] Regular voltage signals of heart beat provide strength signals as voltage levels that are related to blood pressure. Times between signals at varied parts of the body or patterns of secondary signals provide information on circulation or blockage or interference with blood flow. [0088] In another preferred embodiment, FIG. 6 shows a schematic view of the P2M system with a single passive sensor 61 positioned on a patient 63 . FIG. 7 shows one of the graphical user interfaces (GUI) of the P2M system. The upper chart 65 shows a 30-second window of digital voltage data, where the low-frequency oscillations are caused by respiration and the higher-frequency spikes are the result of heartbeat measurements of the patient on the litter. The time-series signal is converted to frequency data via a Fourier transform and displayed as a power spectrum, shown in the middle chart 67 . From this data, pulse and respiration can be extracted by examining the power associated with the dominant frequencies 69 . [0089] In a preferred method of blood pressure measurement passive measurement of blood pressure (systolic and diastolic) may be conducted using pulse wave analyses. Measurement and characterization of the pulse-wave velocity (PWV), or alternately, the pulse-wave travel time (PWTT), inherently requires more than one measurement location. Thus, plural sensors are required for measurements in different locations. The sensors may measure pulse-wave characteristics, for example, along the brachial artery, along with other measurements described herein. [0090] FIG. 8 shows measurement results of the pulse at two locations along the arm. The temporal separation between the two corresponding peaks 71 , 73 gives the Pulse-Wave Travel Time (PWTT). This value can be used to correlate systolic and diastolic blood pressure. As such, the calibration must be performed simultaneously for several measurements of PWTT and blood pressure to construct a calibration curve. Barschdorff & Erig showed that the relationship between blood pressures (systolic and diastolic) are approximately linear with PWV and PWTT. [0091] Testing and evaluation of the P2M system was performed at TAMC in February, 1998. Simultaneous measurements of pulse and respiration were performed with the P2M, an electronic monitor, and by human evaluation. FIG. 9 shows a photograph of the testing performed at TAMC. A total of 11 volunteers were monitored following the project's testing protocol. [0092] FIG. 10 displays the results of the testing. The P2M was over 95% accurate as compared to conventional methods, and the several instances where the P2M was not in agreement with conventional methods proved to be very valuable in subsequent modifications and improvements to the system software. In addition, 12 volunteer nurses performed physiological monitoring of pulse and respiration using the P2M, electronic monitor, and human evaluation. Following the monitoring, the nurses completed a survey comparing and ranking the usage of the three methods. [0093] Testing of the P2M system for pulse and respiration in a high noise and vibration environment was performed at Wheeler Army Air Field, on Mar. 5, 1999. Tests were-performed during static display of a MEDEVAC helicopter. The main purpose of the test was to characterize the high noise/vibration environment using the P2M, microphones and accelerometers. Results showed that through filtering and signal analyses, the P2M was able to discern physiological signals from the high amplitude and frequency noise caused by the helicopter to output accurately pulse and respiration. No conventional methods were performed at this test due to the high-noise environment, which would render those methods useless. [0094] FIG. 11 shows the high noise and vibration testing of P2M at Wheeler Army Air Field, on Mar. 5, 1999. [0095] Next, in response to inquiries made by the flight medics during the Mar. 5, 1999 testing at Wheeler, the ability of P2M system to accurately monitor pulse and respiration through layers of clothing and gear was tested. Fragmentation protective body armor, Military Oriented Protective Posture (MOPP) gear, and a combination of the two were tested using the P2M system. Results showed that the P2M performed with higher fidelity with the additional layers between the subject and the sensor, which is largely due to the increased contact area and efficient transmission of mechanical and acoustic signals through the solid layers. [0096] The single-sensor P 2 M configuration that has been demonstrated to accurately measure pulse and respiration is very sensitive to the patient position relative to the main sensor pad. The quality and magnitude of the physiological signals received by the system depends on this positioning. The preferred optimum placement is to situate the sensor directly beneath the center of the patient's chest. If the sensor is moved from this placement, or if the patient position changes, the integrity of the incoming signal also changes. Thus, a preferred configuration uses multiple sensors in a pattern that covers the entire region of the litter on which the patient would lie so that regardless of patient movement and position, there will always be one or more active sensors in optimum measurement placements. [0097] In a preferred embodiment, the invention is a passive system using an array of distributed sensors (or “multi-sensor”) capable of accurately and robustly monitoring certain physiological signals of the human body. These signals, in turn, may be processed for determination of vital signs that are currently used by nurses and other caregivers, for example, heart rate, respiration, and systolic/diastolic blood pressure. [0098] Passive monitoring of such parameters as cardiac output, cardiac function, and internal bleeding are within the scope of this invention. The invention uniquely provides a device that is passive (completely non-invasive), unobtrusive, and autonomous; i.e., the apparatus in no way interferes either with the patient's mobility or with other monitoring equipment, and is capable of functioning with a minimum of technical expertise. In addition, the equipment functions reliably in high-noise environments and other situations that render alternative and existing methods ineffective. These environments include, but are not limited to, medical evacuation (MEDEVAC) by helicopter or ambulance, and operation through Military Oriented Protective Posture (MOPP) gear and body armor. [0099] With the development of a reliable multi-sensor monitoring system for such rugged and noisy operation, the application to the hospital ICU environment, where noise is substantially lower, is considerably more straightforward. Completely non-invasive, passive, pulse, respiration, blood pressure (and detection of cardiac output, internal bleeding, shock, etc.) measurements using a sensor system that is undetectable to the patient have considerable intrinsic value even in noise-free surroundings. The passive and autonomous operation of such a system is suitable for telemetry and real-time remote monitoring, and the final feature of the invention is a telemetry design feature for distance and remote monitoring. [0100] FIG. 14 shows a schematic of the P2M using a passive sensor array and microelectronics incorporated into a MEDEVAC litter. A schematic of the inventive technology, incorporated into a MEDEVAC litter, is shown in FIG. 14 below. The litter 75 is covered in an array 77 of 32 sensors, each of which can measure acoustic and hydraulic inputs from the patient 63 . Each of these signals contains a measure of physiologically generated signal and environmental noise. The environmental noise on each pad will be similar, whereas the physiologically generated signals may be position dependent. This information is used to separate the signal from the noise using proven techniques. Position dependent physiological signals are used to determine patient position, heart rate, respiration, blood pressure, pulse strength distribution, and potentially some measure of cardiac output. [0101] The invention may be incorporated into a wide range of applications apart from the MEDEVAC litter. The passive sensor array may be configured without much change to operate on a hospital bed or an ordinary mattress used at home. Of particular note is the area of premature infant care. In this case, the attachment of sensor leads to the infant may often be difficult, causing irritation of sensitive skin and entanglement in leads. The sensor may be incorporated into equipment for use in both civilian and military sectors. The sensor may be incorporated into field equipment, clothes and uniforms. This includes, but is not limited to, cervical collars, body armor, biological and/or chemical hazard protection suits, extraction devices, clothes, cushions on seats and seatbacks. Exercise equipment, such as stationary bicycles, treadmills or steppers may benefit by incorporating sensors into the supports. [0102] Physiological indicators such as heart rate may be detected through handholds as an aid to regulating the exercise regime. Other useful applications might include the use of a passive sensor system in a chair or couch used for psychological examinations. Scrutiny of the subject's physiological signs may give indications of emotional disturbance caused by trigger words or events during counseling. The size of each sensor, number of sensors in the array, and configuration of the sensor array may be tailored, without much experimentation, to particular needs and situations. For a mattress, for example, 32 or more sensors in a rectangular array may be required. [0103] The preferred passive sensor may use piezo-electric films and ceramics, hydrophones, microphones or pressure transducers. Amplification hardware may include signal amplification circuitry and hardware, e.g., charge amplifier. Data acquisition hardware and signal processing hardware (circuitry) and software are used in the system. For the interface between sensor and patient either solid, fluidized (air) or fluid layer may be used, as for example, gel, water, foam, rubber, plastic, etc. The interface facilitates transmittal of physiological signals. [0104] The invention has great medical value for field monitoring, hospital monitoring, transport monitoring, and home/remote monitoring. For example, the invention may have application in every hospital for passive monitoring of patients. The invention being undetectable to the patient, which adds comfort to the monitoring process. [0105] While the invention has been described with reference to specific embodiments, modifications and variations of the invention may be constructed without departing from the scope of the invention.

1a

FIELD [0001] This application relates to the transdermal administration of ionic solutions, drugs and cosmetics. [0002] More particularly, this application relates to active iontophoretic delivery systems in which a hand-held roller-ball applicator forming an electrical contact applied to the surface of the skin of a subject for the purpose of delivering agents through the surface of the skin into underlying tissues. BACKGROUND [0003] Iontophoresis uses electrical current through a body, such as human or animal, to drive charged ionic particles into the skin. Some ionic particles may be drugs or cosmetic solution. During active iontophoresis, direct electrical current is used to cause ions of a solution, such as a medicament, to move across the surface of the skin and to diffuse into underlying tissue. The surface of the skin is not broken by the iontophoresis. When conducted within appropriate parameters, the sensations experienced by a subject during the delivery of the ionic solution in this manner are not unpleasant. Therefore, active iontophoresis presents an attractive alternative to hypodermic injections and to intravascular catheterization. [0004] Iontophoresis has been used with patches that allow a current flow and ionic treatment of a particular area of the body. As such, conventional iontophoresis has used patches to allow sufficient time for the current to drive an ionic solution into a particular part of the body. Due to the limitations of current and patch size, only specific, discrete areas of skin covered by an iontophoretic patch accept the transdermal ionic solution transfer. SUMMARY [0005] Embodiments of iontophoretic devices are disclosed which may include a reservoir; a roller-ball applicator coupled to the reservoir and configured to dispense contents of the reservoir; a power supply; a first electrode electrically coupled to a pole of the power supply; and a second electrode coupled to the other pole of the power supply. The devices may be configured such that a current travels between the first electrode and the second electrode through the skin of a subject when the device is used. [0006] In some embodiments, the roller-ball applicator may include the first electrode, a roller-ball, and a fitment, the roller-ball comprising a conductive material. In such embodiments, the roller-ball may function as the first electrode. Similarly, some embodiments may include a handle, wherein the second electrode is included on the handle, such that the second electrode may be configured to be grasped by the hand of the subject. The reservoir may contain an ionic solution. Iontophoretic devices may also include a control circuit disposed between the power supply and one of the first and second electrodes. The device may be configured for a single use only, or the reservoir may be refillable or replaceable. The device may also include a cap to fit over the roller-ball applicator. [0007] Some exemplary methods of iontophoretic application may include placing ionic fluid in a reservoir; coupling the reservoir to a roller-ball applicator, the roller-ball applicator having a roller-ball and a handle; grasping the handle; placing the roller-ball against the skin of an individual; dispensing the ionic fluid by way of the roller-ball onto the skin of the individual; and applying current between the roller-ball and the skin of the individual such that the ionic fluid is delivered iontophoretic ally into the skin of the individual. BRIEF DESCRIPTION OF THE DRAWINGS [0008] The following description can be better understood in light of Figures, in which: [0009] FIG. 1 illustrates a schematic view of an exemplary iontophoretic roller-ball applicator; [0010] FIG. 1 b illustrates schematic view of an exemplary iontophoretic roller-ball applicator being used; [0011] FIGS. 2 a and 2 b illustrate an exemplary iontophoretic roller-ball applicator; [0012] FIG. 3 illustrates a cross-sectional view of the exemplary iontophoretic roller-ball applicator of FIG. 2 a; [0013] FIG. 4 illustrates an exploded view of the exemplary roller-ball applicator of FIG. 3 ; [0014] FIGS. 5 and 6 illustrate exemplary embodiments of portions of iontophoretic roller-ball applicators; [0015] FIG. 7 illustrates an exemplary iontophoretic roller-ball applicator; and [0016] FIG. 8 illustrates an exemplary iontophoretic roller-ball applicator. [0017] Together with the following description, the Figures demonstrate and explain the principles of iontophoretic roller-ball applicators and methods for making and using the iontophoretic roller-ball applicator. In the Figures, the thickness and configuration of components may be exaggerated for clarity. The same reference numerals in different Figures represent the same component. DETAILED DESCRIPTION [0018] The following description supplies specific details in order to provide a thorough understanding. Nevertheless, the skilled artisan would understand that the apparatus and associated methods of using the apparatus can be implemented and used without employing these specific details. Indeed, the apparatus and associated methods can be placed into practice by modifying the illustrated apparatus and associated methods and can be used in conjunction with any other apparatus and techniques conventionally used in the industry. For example, while the description below focuses on iontophoretic roller-ball applicators powered with a battery, applicators may also be powered from a wall socket. [0019] Iontophoretic roller-ball applicators described below may provide a user with a manipulable device that may used to apply ionic solution, such as a medicament, to treat an area of skin with iontophoresis. Iontophoretic roller-ball applicators may provide additional massaging or stimulation to skin to facilitate the iontophoresis and to provide the iontophoresis to a larger area of skin than traditional attached patches, which are placed and held in a single location. Additionally, the ionic solution applied to the skin may be conductive and continue with iontophoresis over a broad area when in conductive contact with the roller-ball of an iontophoretic roller-ball applicator, which may function as an electrode in the iontophoresis process, as will be explained in more detail below. [0020] The direct current employed in active iontophoresis systems may be obtained from a variety of electrical power sources. These may include electrical equipment that ultimately receives power from a wall socket, paired regions of contrasting galvanic materials that when coupled by a fluid or a gel medium produce minute electrical currents, capacitors, consumable and rechargeable batteries, etc. A flow of electrical current may require an uninterrupted, electrically-conductive pathway from the positive pole of a power source to the other, negative pole of the power source. Living tissue may be made up primarily of fluid and may be, therefore, a conductor of electrical current. In an iontophoretic circuit, the opposite poles of a power source may be electrically coupled to respective, separated contact locations on the skin of the subject. The difference in electrical potential created by the power source between those contact locations may cause a movement of electrons and electrically charged molecules, or ions, through the tissue between the contact locations. [0021] In an active iontophoretic delivery system, the polarity of the net overall electrical charge on dissolved molecules of an ionic solution, including solutions with medicaments and/or cosmetics, may determine the contact location on the skin at which a supply of the ionic solution of must be positioned. A positively charged ionic solution in a reservoir against the skin of a patient may be coupled to the positive pole of any power source that is to be used to administer the ionic solution iontophoretically. Correspondingly, a reservoir on the skin of a patient containing a negatively charged ionic solution may be coupled to the negative pole of such a power source. Examples of common iontophoretically administrable ionic solutions of positive polarity include Bupivacaine hydrochloride, Calcium chloride, Lidocaine hydrochloride, Zinc chloride, and Lidocaine. Examples of common iontophoretically administrable ionic solutions of negative polarity include Betamethasone sodium phosphate, Dexamethasone sodium phosphate, Fentinol, Copper sulfate, Acetic acid, Magnesium sulfate, Naproxen sodium, Sodium chloride, and Sodium salicylate. [0022] The ionic solution supply may be housed in a fluid reservoir that is positioned electrically conductively engaging the skin of the subject at an anatomical location overlying the tissue to which ionic solution is to be administered. The ionic solution reservoir can take the form of a gel suspension of the ionic solution or of a pad of an absorbent matrix, such as gauze or cotton, which is saturated with fluid containing the ionic solution. In some instances the fluid containing the ionic solution is provided from the manufacturer in the absorbent matrix. More commonly, the fluid is added to the absorbent matrix by a medical practitioner at the time that the ionic solution is about to be administered to a subject. [0023] As shown in FIG. 1 a, an iontophoretic circuit 10 for driving an ionic solution through unbroken skin 5 may be established by coupling the appropriate pole of power source 12 through ionic solution reservoir 30 and through roller-ball 70 to skin 5 of a subject at the anatomical location at which the ionic solution is to be administered. Roller-ball 70 may function as an electrode connected to one pole of power source 12 and provide an electrical pathway from power source 12 to skin 5 of a subject. Simultaneously, the other electrode 16 may be coupled to a pole of power source 12 may be coupled to an anatomical location on skin 5 of the subject that is distanced from ionic solution reservoir 30 and roller-ball 70 . For example, a negative pole may be connected to electrode 116 , which may be contacted by the hand of an individual holding an iontophoretic applicator 100 while roller-ball 170 applies ionic solution at a desired location, as shown in FIG. 1 b. [0024] The coupling of each pole of power source 12 may be affected by the electrical connection of each pole to a respective electrode. The electrode forming the roller-ball and delivering the ionic solution from reservoir 30 may be referred to as an active electrode; the electrode 16 at the location on skin 5 distanced from the roller-ball 70 may be referred to as a return electrode. The electrical potential that is imposed across ionic solution reservoir 30 of an iontophoretic circuit may produce electrical current flow I s by causing electrolysis in some of the molecules of the water (H 2 O) in the solution in reservoir 30 . Skin 5 provides resistance R s for circuit 10 between electrode 16 and roller-ball 70 . Control circuit 20 may regulate and control current through circuit 10 . [0025] In some embodiments, such as when a person is using the applicator 100 to treat another person, a separate contact (not shown) between the skin 5 of the individual being treated and the other person performing the treatment may be provided to close the circuit between the electrode 16 and the skin 5 of the individual being treated. In some embodiments, this may simply be the person performing the treatment touching in a skin-to-skin manner the person being treated, or a cord extending from the applicator 100 with a remote electrode may be placed on or attached to the skin 5 of the individual being treated. [0026] In electrolysis, the positively-charged hydrogen ion (H 30 ) of a water molecule may then becomes separated from the negatively-charged hydroxyl radical (HO − ) of that same molecule. These ions and radicals may then migrate in respective opposite directions through the solution in the ionic solution reservoir. The hydrogen ions (H + ) may then move toward the negative pole of the electrical potential being imposed on the solution, while the hydroxyl radicals (HO − ) move toward the positive pole. This may in turn drive the treatment solution ions M + into skin 5 . [0027] Ionic solution reservoir 30 may be contained within a roller-ball applicator, with an associated active electrode conveniently retained against skin 5 by contact with roller-ball 70 , with roller-ball 70 functioning as the electrode as described in detail below, while return electrode 16 may be retained against skin 5 through the handle of the roller-ball applicator. [0028] FIGS. 2 a and 2 b illustrate an embodiment of iontophoretic roller-ball applicator 100 Iontophoretic roller-ball applicator 100 may include body 110 with electrode 116 , base 112 , solution fitment 160 with roller-ball 170 , and cap 150 . FIGS. 3 and 4 illustrate the components of some embodiments of iontophoretic roller-ball applicator 100 in greater detail. In some embodiments, iontophoretic roller-ball applicators described may be reusable, or may be a single use applicator. [0029] In the embodiments of FIGS. 3 and 4 , body 110 houses various components for iontophoretic roller-ball applicator 100 . Base 112 may be removably or permanently connected to body 110 . Base 112 may also provide an electrical pathway between power source 122 and electrode 116 , located on the outer surface of body 110 . Body 110 may be formed such that it may be grasped by the hand of an individual, with electrode 116 being located to contact the hand of the individual grasping body 110 . Body 110 may be formed of a non-conductive material to provide insulation between electrode 116 and roller-ball 170 . [0030] Base 112 may be formed of any suitable material, such as a conductive material, or a non-conductive material with a conductor to connect power source 122 to electrode 116 . Some suitable materials may include metals, a plastic with a conductive coating, conductive plastic, conductive ceramic, conductive carbon etc. Power source 122 may be any suitable power source such as batteries, which may also include board circuitry to control current output, a connection to a wall outlet, capacitors, etc., to provide sufficient current over time to affect an iontophoretic process, for example between about 0.00001-100 mAmps. Power source 122 may be DC to provide a steady current to drive an ionic solution into the skin of a subject using iontophoretic roller-ball applicator 100 . Lead 126 may connect power source 122 to control circuit 120 . Control circuit 120 may function to provide and maintain the correct current flow between electrode 116 and roller-ball 170 when being used. [0031] Lead 124 may connect control circuit 120 to conductive post 128 through plate 114 . Plate 114 may function to separate and protect the electronic components in the lower portion of body 110 from the upper portion of body 110 , which houses reservoir 130 of ionic solution. Plate 114 may be formed of a non-conductive material, such as plastic, or any other suitable material. In some embodiments, control circuit 120 may be directly connected to power source 122 external to base 112 . [0032] In the embodiment of FIGS. 3 and 4 , conductive post 128 may contact reservoir 130 . Reservoir 130 may be formed of a conductive material that allows current from power source 122 and control circuit 120 to reach roller-ball 170 . Or in some embodiments, a layer of conductive material may provide a pathway from conductive post 128 . For example, a bottom portion of reservoir 130 may be conductive and in conductive connection with an inside coating of conductive material in the interior portion of reservoir 132 . Similarly, reservoir walls 132 may include one or more conductors extending to ring 172 that would allow an ionic fluid in reservoir 130 to be charged and conduct electricity to complete a circuit when iontophoretic roller-ball applicator 100 is being used. [0033] As such, in some embodiments the fluid in reservoir 130 may function as the conductor. In such embodiments, roller-ball 170 may be formed of a non-conductive material, the current being conveyed by the fluid flowing from reservoir 130 to skin 5 . Iontophoresis may cease when the fluid is depleted, by breaking the circuit and thereby automatically stopping the iontophoresis treatment. [0034] Reservoir 130 may be replaceable or removable in some embodiments where iontophoretic roller-ball applicator 100 is reusable. In other embodiments, reservoir 130 may be affixed to the upper portion of body 110 . Similarly, reservoir 130 may fit snugly in body 110 as a selectively removable attachment. As shown, fitment 160 may be coupled to reservoir 130 through cooperative connection of complimentary threads 134 of reservoir 130 and threads 164 of fitment 160 . [0035] In some embodiments where iontophoretic roller-ball applicator 100 is not reusable, fitment and reservoir 130 may be permanently affixed using adhesive or other suitable affixment. Similarly, fitment 160 may be permanently affixed to body 110 such that when reservoir 130 is empty, iontophoretic roller-ball applicator 100 may cease to function and would no longer be useful. In such embodiments and other reusable embodiments, no current would flow when iontophoretic roller-ball applicator 100 is in an upright position and no fluid is present outside of reservoir 130 , or when the fluid level in reservoir 130 does not permit an electrical connection between roller-ball 170 and conductive post 128 . [0036] Ring 172 may be located in fitment 160 and on top of reservoir 130 to provide a seat for roller-ball 170 . Ring 172 may be formed as part of fitment 160 , or it may be compressed between reservoir 130 and fitment 160 when assembled. Ring 172 may be conductive and attach to a conductive portion of reservoir 130 to allow current to flow to roller-ball 170 . In some embodiments, fitment 160 may be formed of a non conductive material having sufficient elasticity that roller-ball 170 may be press-fit into fitment 160 and retained by the top portion of fitment 160 , as the top portion returns to its diameter. The diameter of the top portion of fitment 160 may be smaller than the diameter of roller-ball 170 to keep roller-ball 170 from falling out. [0037] In other embodiments, fitment 160 may be formed of a conductive material, such as metal, that would not permit press-fitting of roller-ball 170 . In such embodiments, roller-ball 170 may be placed inside of fitment 160 through the bottom prior to attachment with reservoir 130 and body 110 , and held in place with ring 172 . Roller-ball 170 may fit relatively loosely within fitment 160 to allow for free rotation and to convey ionic fluid from reservoir 130 to skin 5 when in use. [0038] Roller-ball 170 may be formed of a conductive material that forms part of the electrical circuit, or it may be formed of a non-conductive material, allowing the current to pass through the fluid as described above. Cap 150 may connect to fitment through fitment threads 162 and cap threads 152 to reduce evaporation, leaking, and spillage of a fluid in reservoir 130 . Cap 150 may be formed of any suitable material, such as metal, plastic, etc. [0039] FIGS. 5-7 illustrate other embodiments of iontophoretic roller-ball applicators, particularly relating to mechanisms for completing a circuit for the iontophoresis. In each of these embodiments, corresponding components to iontophoretic roller-ball applicator 100 are similarly numbered. For example, roller-ball 270 of iontophoretic roller-ball applicator 200 corresponds to roller-ball 170 of iontophoretic roller-ball applicator 100 . [0040] In FIG. 5 , iontophoretic roller-ball applicator 200 conductive post 228 extends into the center of reservoir 230 and up to roller-ball 270 . Similar to iontophoretic roller-ball applicator 100 , conductive post 228 may contact roller-ball 270 or may leave a gap between conductive post 228 and roller-ball 270 such that the fluid in reservoir 230 forms part of the circuit and that iontophoretic roller-ball applicator 200 stops functioning when the fluid is depleted. Ring 272 , fitment 260 , roller-ball 370 , and cap 250 may be formed and function in the various embodiments as described above with respect to the similar components of iontophoretic roller-ball applicator 100 . [0041] In FIG. 6 , iontophoretic roller-ball applicator 300 reservoir 330 may be formed of or coated with a conductive material such that ring 372 or fluid in reservoir 330 may provide electrical connection for the iontophoretic process when iontophoretic roller-ball applicator 300 is used. Ring 372 , fitment 360 , roller-ball 370 , and cap 350 may be formed and function in the various embodiments as described above with respect to the similar components of iontophoretic roller-ball applicator 100 . [0042] In FIG. 7 , iontophoretic roller-ball applicator 400 may be reusable and provided to use a standard liquid medicament vial 436 . Vial 436 may be positioned in body 410 in well 430 . Well 430 may provide an electrical pathway to ring 472 from a power source, similar to the embodiments discussed above. Ring 472 may include needle 476 attached to ring 472 or formed in the ring. Needle 476 may be used to pierce the top of vial 430 similar to how hypodermic needles are used to pierce the same vials in other applications. Fitment 460 , roller-ball 470 , and cap 450 may be formed and function in the various embodiments as described above with respect to the similar components of iontophoretic roller-ball applicator 100 . [0043] Turning now to FIG. 8 , iontophoretic roller-ball applicator 500 may include reservoir 536 along with reservoir 530 to provide ionic fluid to roller-ball 570 concurrently or sequentially, depending on the contents of the reservoirs and the desired treatment regimen. For example, some medications may be more effective when used with other medications, or with a skin conditioner. Similarly, other embodiments may provide three or more different reservoirs. [0044] Additionally, body 510 may be shaped in a different ergonomic configuration than iontophoretic roller-ball applicator 100 , as shown in other figures and described above. Similarly, electrode 516 may be contoured to fit a hand and body 510 may be angled to give a gentler wrist position of an individual holding the applicator. The various components of iontophoretic roller-ball applicator 500 may be formed and function similarly to those of the various embodiments as described above with respect to the similar components of iontophoretic roller-ball applicator 100 . In some embodiments, a single reservoir 536 may be positioned as shown in FIG. 8 to allow for easy changing or refilling of reservoir 536 . [0045] In some embodiments, multiple roller-balls may be employed to engage a broader region. The bodies and handles of various iontophoretic roller-ball applicators may be formed and shaped to be of varying sizes and shapes depending on the desired aesthetic and ergonomic considerations of the applicator being used. Similarly, iontophoretic roller-ball applicators may be formed with specific shapes and sizes to accommodate particular areas of the body. For example, very small roller-balls may be used with iontophoretic roller-ball applicators for treating areas under the eyes, or fine wrinkles around the mouth and eyes, while a large ball may be used to treat large muscle groups such as those in legs, arms, and torso. [0046] In other embodiments, iontophoretic roller-ball applicators may include a display in the body to indicate the amount of charge, time, and/or reservoir capacity used or remaining. Similarly, the iontophoretic roller-ball applicators may include switches to turn on the applicators and/or adjust the current to a desired level. Iontophoretic roller-ball applicators may turn on automatically with a circuit is completed between the electrodes and described above. [0047] The various iontophoretic roller-ball applicators described may be used to provide several advantages over previous iontophoretic application systems. For example, medications or treatments may be made over a larger area of skin and a user may concentrate with varying intensities of particular trouble spots of on a region with an irregular shape that would be difficult to treat effectively with an iontophoretic patch. [0048] Additionally, medications delivered by an active iontophoretic system may bypass the digestive system, which reduces digestive tract irritation. In many cases, ionic solutions administered orally may less potent than if administered transcutaneously. In compensation, it may be necessary in achieving a target effective dosage level to administer orally larger quantities of ionic solution than would be administered transcutaneously. [0049] Active iontophoretic systems may not require intensive skin site sanitation to avoid infections. Equipment used in active iontophoresis may not interact with bodily fluids and, accordingly, need not be disposed as hazardous biological materials following use. Being a noninvasive procedure, the administration of ionic solution using an active iontophoretic system may not cause tissue injury of the types observed with hypodermic injections and with intravenous catheterizations. Repeated needle punctures in a single anatomical region, or long term catheter residence, can adversely affect the health of surrounding tissue. Needle punctures and catheter implantations inherently involve the experience of some degree of pain. These unintended consequences of invasive transcutaneous ionic solution administration are particularly undesirable in an area of the body that, being already injured, is to be treated directly for that injury with an ionic solution. Such might be the case, for example, in the treatment of a strained muscle or tendon. [0050] The dosage of an ionic solution delivered iontophoretically may be conveniently and accurately measured by monitoring the amount and the duration of the current flowing during the administration. Similarly, the application may be completed with fluid contained in the reservoirs is depleted and the system stops. As such, the successful operation of an active iontophoretic system is not reliant on the medical skills of nurses or doctors. Foregoing the involvement of such medical personnel in the administration of ionic solutions whenever appropriate favors the convenience of patients and reduces the costs associated with the delivery of such types of therapy. [0051] In addition to any previously indicated modification, numerous other variations and alternative arrangements may be devised by those skilled in the art without departing from the spirit and scope of this description, and appended claims are intended to cover such modifications and arrangements. Thus, while the information has been described above with particularity and detail in connection with what is presently deemed to be the most practical and preferred aspects, it will be apparent to those of ordinary skill in the art that numerous modifications, including, but not limited to, form, function, manner of operation and use may be made without departing from the principles and concepts set forth herein. Also, as used herein, examples are meant to be illustrative only and should not be construed to be limiting in any manner.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Application Ser. No. 60/748,176, filed Dec. 8, 2005, incorporated herein by reference. TECHNICAL FIELD For medical devices which are formed in vivo the biocompatibility profile, especially during the initial reactive stage, is of specific importance. Many chemically bonded ceramics, and especially aluminate and silicate ceramics, which are formed as a result of an acid-base reaction, exhibit a high pH-range during the first hours. The present invention is directed to such compositions exhibiting a lowered pH range during the initial reaction period. The composition of the invention is especially intended for endodontic and orthopaedic applications, and also for soft tissue applications. STATE OF THE ART AND PROBLEM Implants that are to interact with the human body should advantageously be composed of materials having a good biocompatibility and bioactivity. An example of such a material is the class known as “chemically bonded ceramics” (CBC). The hardening of such materials is accomplished by chemical reaction with water, involving formation of stable hydrates, precipitation and crystallization thereof, which reaction takes place already at ambient temperature, such as for example in in vivo conditions. Chemically bonded ceramics have been shown to be bioactive in the sense that the materials in contact with phosphate solution (both in vitro and in vivo) form apatite in the contact zone between the biomaterial and the tissue. Examples of such materials are the high strength CBC materials, which are based on Ca-aluminates and/or Ca-silicates, such as those described in SE463493, SE502987, WO 2000/021489, WO 2001/076534, WO 2001/076535, WO 2004/037215, WO 2004/00239 and WO 2003/041662. Said materials have been proposed for use in dental applications. It would be desirable to be able to use such materials also in endodontic and orthopaedic applications. Accordingly, it is an object of the present invention to improve the characteristics of the above materials in order to make them better suited for use in endodontic and orthopaedic applications. For a CBC material producing an initial pH of ≧10 on hydration the problem has been solved by means of the characterizing features of claim 1 , according to which a solid phase buffer component is included in the CBC material forming powder composition. SUMMARY OF THE INVENTION The present inventors have found the inherently high pH value produced on hydration of many of the above prior art materials to make them less suited for use in endodontic and orthopaedic applications. As an example, most of the above Ca-aluminates and Ca-silicates hydrate in the basic pH-range of 10.5-12.5. This is especially believed to be a problem when said materials are to be used in applications other than dental applications and coatings on implants requiring larger amounts of the material. The high pH value has been found to be connected with the initial hydration reaction of the material (see Tables 1 and 2 for Ca-aluminate and Ca-silicate, respectively). After the initial reaction the subsequent diffusion controlled reaction is controlled with regard to pH by the body liquid buffer system. Accordingly, after the initial hydration reaction, which has been found to be intense during the first hours up to one day, and especially during the first 4 hours, the use of Ca-aluminate and Ca-silicate systems should no longer be problematic. The present inventors have now found that the initially high pH value produced on hydration can be successfully controlled to be within a reduced pH range already after 1 hour of hydration reaction by including a solid phase buffer component in the powder system forming the CBC material. Such powder system is provided for in claim 1 . The system is especially intended for endodontic and orthopaedic applications. According to the present invention the period of time during which an alkaline CBC system produces a critically high pH value in vivo can be markedly reduced. Therefore, the inventive CBC system containing the buffer component will to a lesser extent affect the endogenous buffer system than the prior art alkaline CBC system not having a buffer component, thus making the inventive system more tolerable in vivo. The use of a buffer component in the solid state according to the invention allows for a very effective buffering action. Also, the use of buffer components exhibiting anions which can form part of the structure of chemically bound material makes the buffering component a more integral part of the system and allows for larger amounts of the buffer component to be used. In addition to endodontic and orthopaedic applications, the material of the invention is also believed to be suitable for soft tissue applications by virtue of the reduced pH during the initial hydration reaction. Further features and advantages of the present invention will be evident from the following detailed description and dependent claims. The system of the invention also allows for incorporation of pH sensitive drugs and/or bone growth promoting agents, prophylactically and/or diagnostically active agents to be released subsequently by the chemically bound ceramic biomaterial in vivo. Examples of such drugs include therapeutic agents for many areas, e.g. pain relief, anesthetics, anti-infective agents and anti-inflammatory drugs, drugs for treatment of immunological disorders, hormonal disruption, clotting behavior, cancer, and combinations thereof. In these cases the agents can be contained in the porous implant, precursor or implant material or as separate porous granules. BRIEF DESCRIPTION OF THE ATTACHED DRAWINGS FIG. 1 shows the pH change over time of a system according to the invention producing a rapid controlled pH change. FIG. 2 shows a plot of the pH as a function of time for a controlled and delayed pH reduction after a given period of time to optimize the hydration during the first 30-60 minutes, and thereafter a substantially reduced pH to a more biocompatible range. DETAILED DESCRIPTION OF THE INVENTION The internal buffer system is composed of a buffering salt of mono-, di-, tri- and/or tetravalent acids. The salts are typically salts of mineral acids of the type [Me:H:Anion], wherein: Me=Na, K, Mg, Ca or similar elements; Anion=CO 3 2− , PO 4 3− , SO 3 2− , SO 4 2− , SiO 4 4− or fluoride; and H=one or more hydrogen ions. In one embodiment the CBC material of the invention is combined with an added acid as dry component in inert particle porosities for a rapid change early in the hydration process, such as improved early-age mechanical properties, as described in WO 2005/039508. The pH change over time is presented in FIG. 1 . Another advantage of a controlled pH reduction after a given period of time according to the invention is the possibility to optimize the hydration during the first 30-60 minutes, and thereafter obtaining a substantially reduced pH to a more biocompatible range. See the pH vs. time plot in FIG. 2 . In such embodiment, in order to achieve an optimized hydration during the first 30-60 minutes, the buffering salt can be impregnated in porous granules of the component forming the chemically bonded ceramic material and/or in an additional porous inert phase. The diffusion of the buffer salt into the surrounding media will thereby be delayed. According to the present invention the initial hydration reaction of very alkaline systems, such as Ca-aluminate and Ca-silicate (with an initial pH value on hydration of 11-12.5), can be effectively controlled to be in a reduced pH range of 7.5-10 already after 1 hour of hydration reaction, preferably within the range 7.5 to 9.5, and more preferably within the range of 7.5 to 9.0, by the use of an internal buffer system added to the powdered biomaterial of CBC type used. The internal buffer system is composed of a buffering salt of mono-, di-, tri- and/or tetravalent mineral acids. The salts are typically acidic salts of the type [Me:H:Anion], wherein: Me=Na, K, Mg, Ca and similar elements; Anion=CO 3 2− , PO 4 3− , SO 3 2− , SO 4 2− , SiO 4 4− and fluoride; and H=one or more hydrogen ions. Very attractive are the acid salts forming the ions HF 2 − , HCO 3 − , HP 4 2− and H 2 PO 4 − in aqueous solutions. Examples of most suitable salts for use as the buffer are: KHF 2 , NaHCO 3 , Mg(Ca)HPO 4 , Na 2 HPO 4 and NaH 2 PO 4 . The pH development has been found to depend on three major material sources; the solid raw material (CBC), the general hydration liquid used, and the body liquid encountered after implantation. Especially effective with high buffering capacity are the solid buffers according to the present invention. The buffering capacity can be expressed as mM OH—. The capacity is as high as 100 mM, corresponding to a pH change from approximately 13 to near neutral, i.e. pH 7-8. The buffering capacity of body liquids are considerably lower due to two aspects; the ion buffering capacity expressed as mM is considerably lower, and secondly the body liquids are external and thus pH reduction is diffusion-time restricted, as generally described in Ceramics, Cells and Tissues, Ed Ravaglioli and Krajewski, pp 200-201, published by IS-TEC-CNR-Faenza, May 2005. The buffering salts are preferably added in solid form to the ceramic powder. However, the salts could also be dissolved in the hydrating liquid, in which case the required buffer salt could be added to the hydration liquid only, or to both liquid and powder in any desired ratio. The skilled person having read the present disclosure can readily establish the necessary amount of a given buffer salt to be added to a given amount of the composition in order to achieve a desired pH value on hydration, e.g. merely by routine pH measurements. With reference to Table 3 it can be seen that the necessary amount is dependent upon the specific CBC material used. For example, the silicate material is more alkaline than the aluminate material and will consequently require a larger amount of any given buffer salt. In general the amount of the buffer is selected so as to obtain a pH value within the range of 7.5 to 10 after 1 hour of hydration reaction, preferably within the range 7.5 to 9.5, and more preferably within the range of 7.5 to 9.0. The amount of the buffer should not exceed 30% by volume of the total volume of the constituents of the powder system in the dry state, since otherwise the mechanical properties of the bound material will be negatively effected. On the other hand, an amount of less than 3% by volume of any buffer salt will not produce a sufficient pH controlling effect. With reference to Tables 1 and 2 it can be seen that the pH in phosphate buffer solution (i.e. a simulated body fluid), declines more rapidly than in water. A volume of 3% of the acid buffer salt of the invention is generally sufficient to produce a pH reduction at 1 hour of hydration of at least 0.5. With reference to the total hydrating system, i.e. the powdery constituents together with hydration liquid, a preferred amount the acidic buffer salt is within the range of 5-20% by weight, and more preferably 5-10% by weight. Suitable Ca-aluminate and/or Ca-silicate systems for implants which can be used in the present invention are described in e.g. Swedish patent applications Nos.: SE 0200637-7, SE 0203223-3 and SE 0203324-1. Additives which can be used are described in SE 463493, SE 502987, WO 00/21489, WO 01/76534, WO 01/76535, WO 2004/037215 and WO 2003/041662, the relevant contents of which are incorporated herein by reference. As disclosed in WO 2005/039508, in order to improve the controllability of the composition's initial viscosity and consistency, and early-age properties (initial strength, pore closure, translucency and early obtained bioactivity), a polycarboxylic acid or a copolymer or a salt or an ester thereof having a molecular weight of 100-250,000, preferably 1000-100,000 could be added to the powder. The amount of the acid or the copolymer, salt or ester thereof must however be selected so as not interfere with the buffering action of the salt, or compromise the desired mechanical properties of the hardened material. A suitable amount is believed to be within the range of 1-15% and preferably 2-5% by weight, based on the powdered material including any dry additives. EXAMPLES Ca-aluminate (CA) and Ca-silicate (C 3 S) were synthesized at 1410 and 1380° C., respectively, in a conventional sintering furnace for 6 h. The materials were crushed and thereafter milled for 72 h in a rotating mill using ceramics containers and with the milling media of Silicon nitride balls (15 mm in diameter) and iso-propanol as liquid. After thin film evaporation the powder was pressed to small pellets. The pellet dimensions were: length, 1=6 mm; and diameter, d=4 mm. The compact density was approximately 59%. In tables 1 and 2 pH development for a pure Ca-aluminate and a pure Ca-silicate phase (0-30 days with exchange of liquid after each test time), respectively, are shown. In table 3 pH development for the systems in examples (tables 1 and 2) with different amounts of three different internal buffer systems added (KHF 2 , NaHCO 3 and MgHPO 4 and NaH 2 PO 4 ) according to table 3 below, are presented. The amount of added internal buffer was a=5, b=10 and c=20 wt-% of the weight of the hydrating system used. TABLE 1 The pure system Ca-aluminate and pH development in water (W) and phosphate buffer solution (PBS). Medium Time zero 1 h 4 h 24 h 1 week 1 month W 11.5 11.3 11.0 9.4 8.8 8.4 PBS 11.5 10.2 9.5 8.0 7.8 7.8 TABLE 2 The pure system Ca-silicate and pH development in water (W) and phosphate buffer solution (PBS). Medium Time zero 1 h 4 h 24 h 1 week 1 month W 12.4 12.0 11.8 10.5 9.0 9.0 PBS 12.4 11.5 10.5 9.5 9.0 9.0 TABLE 3 Ca-aluminate (CA) and two different types of internal buffer components in phosphate buffer solution, (1-3 = KHF 2 , 4-6 = , NaHCO 3 ) and Ca-silicate (C 3 S) and two different types of internal buffer components in water (7-9 = and MgHPO 4 and 10-12 = and NaH 2 PO 4 ). Type 1 2 3 4 5 6 7 8 9 10 11 12 a = 5 b = 10 b = 20 a = 5 b = 10 c = 20 a = 5 b = 10 c = 20 a = 5 b = 10 c = 20 After 11.5 11.5 10.5 11.5 11.0 10.0 12.3 11.8 11.5 12.0 11.2 10.2 5 min 1 5 min 2 11.3 11.3 10.0 11.0 10.5 9.5 12.0 11.5 11.2 11.5 10.5 9.8 1 h 9.5 9.3 9.0 9.5 9.0 9.0 10.0 10.0 9.8 9.0 8.5 8.0 4 h 9.0 9.0 8.5 8.5 8.0 8.0 10.0 10.0 9.7 8.5 8.0 8.0 24 h 8.0 8.0 7.8 8.5 8.0 8.0 9.5 9.0 9.0 8.0 8.0 8.0 1 w 8.0 8.0 7.8 8.5 8.0 8.0 8.5 8.0 8.0 8.0 8.0 7.7 1 m 8.0 8.0 7.8 8.0 8.0 7.5 8.0 8.0 8.0 8.0 8.0 7.7 1 After 5 min means 5 min after start of mixing the powder and liquid. 2 5 min means 5 min after mixing is completed. The mixing takes approx. 2 minutes.

1a

CROSS REFERENCE TO RELATED APPLICATION [0001] This application is a continuation-in-part application of U.S. application Ser. No. 10/202,294 that was filed with the United States Patent and Trademark Office on Jul. 23, 2002. FIELD OF THE INVENTION [0002] The present invention relates to food compositions containing specified lecithins suitable for many applications such as calf milk replacers. BACKGROUND OF THE INVENTION [0003] Lecithin is used as an emulsifier in numerous applications including food and feed. Lecithin is added to animal feed to achieve an improved nutritive value of the feed or to achieve a better emulsion and dispersion in the case of liquid feed. The emulsifying properties of lecithin are not only exploited in livestock production by inclusion of lecithin in dry rations but also in areas where animals are given liquid feed containing a large proportion of fat. These are primarily milk replacements for calves and sow milk substitutes for piglets. The function of lecithins is to produce the finest possible dispersion of the fat in the ready prepared liquid feed. The fine dispersion results in improved digestibility of the fat by the animals. In addition, the lecithin exhibits a favorable effect on the settling of insoluble constituents in a liquid feed. SUMMARY OF THE INVENTION [0004] The compositions according to the invention are oil-in-water emulsions. The present invention relates to a composition suitable for use as a calf milk replacer comprising from about 1 wt. % to about 30 wt. % fat phase, from about 70 wt. % to about 99 wt. % aqueous phase, and from about 0.05 wt. % to about 5.0 wt. % of a membrane separated lecithin having a ratio of alkali metals to alkaline earth metals ranging from greater than 0 to about 10, preferably greater than 0 to about 5. In another embodiment, the composition comprises from about 1 wt. % to about 30 wt. % fat phase, from about 70 wt. % to about 99 wt. % of an aqueous phase, and from about 0.05 wt. % to about 5.0 wt. % of a lecithin having a ratio of alkali metals to alkaline earth metals ranging from about 1.6 to about 3.0, preferably about 1.8 to about 2.8. The fat phase may comprise any vegetable and/or animal oils or fats that are natural or modified, for example, chemically, physically or enzymatically. DETAILED DESCRIPTION OF THE INVENTION [0005] The compositions according to the invention are oil-in-water emulsions. The present invention relates to a composition suitable for use as a calf milk replacer comprising from about 1 wt. % to about 30 wt. % fat phase, from about 70 wt. % to about 99 wt. % aqueous phase, and from about 0.05 wt. % to about 5.0 wt. % of a membrane separated lecithin having a ratio of alkali metals to alkaline earth metals ranging from greater than 0 to about 10, preferably greater than 0 to about 5. In another embodiment, the composition comprises from about 1 wt. % to about 30 wt. % fat phase, from about 70 wt. % to about 99 wt. % of an aqueous phase, and from about 0.05 wt. % to about 5.0 wt. % of a lecithin having a ratio of alkali metals to alkaline earth metals ranging from about 1.6 to about 3.0, preferably about 1.8 to about 2.8. The fat phase may comprise any vegetable and/or animal oils or fats that are natural or modified by interesterification, hydrogenation, fractionation, and the like. [0006] The composition of the present invention can be produced by any known methods. For example, a fat phase is prepared comprising an oil and a lecithin product of the present invention. The fat phase is mixed with an aqueous phase. [0007] In the present composition, the fat phase of about 1 wt. % to about 30 wt. % of any oil is used. In particular, the fat phase suitable for use is about 2 wt. % to about 15 wt. %. Any oil, which may be solid or liquid at ambient temperature, can be used in the present food composition. Suitable vegetable oils for use include, for example, soybean oil, sunflower oil, rapeseed oil, cottonseed oil, olive oil, corn oil, ground nut oil, safflower oil, linola oil, linseed oil, palm oil, coconut oil, all of which may be partially or completely hydrogenated or modified otherwise, and mixtures thereof. Particularly useful are soybean oil and partially hydrogenated soybean oil. Suitable oils of animal origin for use include, for example, butterfat and fish oil. [0008] In addition to the above-mentioned ingredients, the fat phase may optionally contain further fat-soluble ingredients. Examples of these materials are colorants, fat-soluble flavors and vitamins, fat soluble emulsifiers and stabilizers, and the like. [0009] The optional aqueous phase of the present composition may comprise water and optionally contain further water-soluble ingredients suitable for use. Examples of these materials are proteins, flavors which are water soluble, emulsifiers, thickeners, salt, sugars, dairy ingredients, preservatives, and the like. [0010] In the present composition, about 0.05 wt. % to about 5.0 wt. % of a lecithin having an acetone soluble content of about 35 wt. % to about 40 wt. % and a ratio of greater than 0 to about 10 of alkali metals to alkaline earth metals in monovalent or divalent ionic state, is used. In particular, a membrane separated lecithin having a ratio of 1.9 alkali metals to alkaline earth metals is used. [0011] The lecithin products of the present invention are in a first embodiment described as membrane separated lecithin having a ratio of alkali metals to alkaline earth metals ranging from greater than 0 to about 10, and in another embodiment ranging from greater than 0 to about 5. In a second embodiment the lecithin products of the present invention are described as lecithins having a ratio of alkali metals to alkaline earth metals ranging from about 1.6 to about 3.0, and in another embodiment ranging from about 1.8 to about 2.8. [0012] In determining the content of the alkali metals and alkaline earth metals of the lecithin product, the following test procedure is used: [0000] Elemental Analysis Standard Procedure SRC [0013] Elemental analysis was performed by Inductively Coupled Plasma-Emission Spectroscopy (ICP-ES) with target elements of aluminum, calcium, chromium, iron, lead, magnesium, nickel, potassium, phosphorus, silicon, sodium, and zinc. This analysis was performed according to the American Oil Chemists' Society (AOCS) Official Method Ca 20-99. Each sample was weighed on an analytical balance to the nearest 0.0001 g. Because of the range of concentration, two dilution levels are required. Approximately 0.8 g of sample was weighted out and recorded. To the sample approximately 4.2 g of kerosene was weighted and recorded. The sample/kerosene mixture was vortexed until the sample is completely dissolved. Approximately 4.2 g mineral oil was added to the sample/kerosene solution and recorded. This concentration is used to analyze the lower level elements, Al, Cr, Fe, Pb, Na, Ni, Si, and Zn. For the higher concentration elements, Ca, Mg, P and K, another dilution is made by taking approximately 0.5 g of the first dilution, recording the weight, and adding approximately 9.5 g of a 50/50 kerosene/mineral oil and record the total weight. All of the final dilutions are mixed until homogeneous. The samples are placed into a heated, 40° C., sample hot plate along with the standards and allowed to come to temperature, approximately 10 minutes, prior to the introduction into the ICP. Samples were run in triplicate. [0000] Calculation: [0014] The ICP data is reported typically as ppm calcium, magnesium, potassium, sodium and phosphorous, along with other metals. The ppm values are divided by the atomic weight of the respective element (Ca:40, K:39, P:31 and Mg:24) and the atomic equivalents are used to calculate the ratio of monovalent to divalent (alkali metals to alkaline earth metals). [0015] The lecithin products of the present invention may be prepared by any suitable manner. For example, a vegetable oil miscella may be passed through a membrane, preferably polymeric or semi-permeable, to obtain a retentate and a permeate. The lecithin products are in the retentate. Exemplary of such methods are those appearing in U.S. Pat. No. 6,207,209 to Jirjis, et al.; U.S. Pat. Nos. 4,496,498 and 4,533,501 to Sen Gupta. Specific examples describing the preparation of lecithin products of the invention are provided as follows: Example A [0016] Two samples of miscella were prepared by using the present technique. Miscella samples were obtained from two different oil seeds plants. [0017] A membrane was conditioned and used for removing phospholipids from each of the two samples of miscella. The membrane purchased was a PAN membrane from Osmonics, Inc. The membrane can be characterized as having an average pore size of 0.3 micron, and in the form of a spiral wound 25 inch×40 inch membrane element. The membrane was conditioned by soaking the membrane in an intermediate solvent (propanol) for 24 hours. Then the membrane was soaked in mixture of intermediate solvent (propanol) and extraction solvent (hexane) for 24 hours. Finally, the membrane was soaked in extraction solvent (hexane) for 24 hours. [0018] The two samples of miscella were individually processed. For the soybean oil miscella, the test was conducted at retentate concentration of 10× of the feed concentration and the permeate rate of 10× concentration was 100 liter/hour m 2 . For the corn miscella, the test was conducted at retentate concentration of 7.4× of the feed at a permeate rate of 80 liter/hour m 2 . Example B [0019] Samples of soybean oil miscella were taken on different days and were treated by using the present technique. [0020] Spiral wound 8 inch×40 inch QX membranes were purchased from Osmonics, Inc. The membranes were conditioned and used for removing phospholipids by soaking them in an intermediate solvent (100% isopropanol) for 12 hours. At 6 hours, the intermediate solvent was recirculated at a flow rate of 15 m3/hr per element and forced through the membrane pores for about 15 minutes using a pump (this recirculation or forcing through is referred to as “forced permeation” for purposes of this Example B). Then the resulting membrane was soaked in a 50:50 mixture of intermediate solvent (100% isopropanol) and extraction solvent (100% commercial hexane) for 12 hours. After 6 hours this soaking included recirculation at a flow rate of15 m 3 /hour per element and forced permeation for about 15 minutes. Finally, the resulting membranes were soaked in extraction solvent (100% commercial hexane) for 12 hours, also with recirculation and forced permeation of the extraction solvent at 6 hours for about 15 minutes with 15 m 3 /hour recirculation flow. The resulting membranes treated with this process are “conditioned membranes” for purposes of this Example B. [0021] The soybean miscella containing about 75 wt. % hexane, 24.3 wt. % crude oil, and 0.7 wt. % phospholipids, was passed through the first conditioned membrane at a trans-membrane pressure of 4 Kgf/cm 2 at a rate of 0.6 m 3 /hour per element. The resulting retentate stream had about 7 wt. % phospholipids and 23 wt. % oil (i.e., the test was conducted at retentate concentration of 10× of the feed concentration). Excess hexane was added to this retentate in the proportion of 2 portions of hexane to 1 portion of retentate resulting in a stream containing 88 wt % hexane. This retentate stream was passed through a second conditioned membrane at a trans-membrane pressure of 4 Kgf/cm 2 at a rate of 0.35 m 3 /hour per element, resulting in a retentate stream having about 65 wt % hexane, 23 wt. % phospholipids and 12 wt. % oil which is equivalent to lecithin free of hexane with 66% acetone insolubles. This retentate stream was desolventized at a rate of 1800 kg/hour, 95° C. and 260 mmHg absolute pressure. The resulting concentration of hexane was 5%. The retentate stream was further desolventized at a temperature of 110° C. at an absolute pressure of 20 mm Hg and sparge steam of 80 kg/hour by using a stripper to produce 600 kg/hour of lecithin product with less than 5 ppm of hexane. [0022] The compositions according to the present invention shows low creaming compared to the standard, which indicates the composition is a good emulsifier. [0023] The composition suitable for use as a calf milk replacer is supported by the following example. It should be understood that the example is not intended to limit the scope of the invention. EXAMPLE [0024] The creaming test was used to determine the emulsifying property of the composition of the present invention suitable for use as a calf milk replacer. A fat phase, representative of the milk composition of a cow, was prepared by mixing 60% refined coconut fat at 50° C. and 40% refined paln oil at 50° C. in a glass beaker. 3.0 grams of membrane separated lecithin having 62 wt. % acetone insolubles and a ratio of 1.9 of alkali metals to alkaline earth metals was placed in a 150-millimeter glass beaker, and 47.0 grams of the fat phase and 5 milligrams of Sudan Red III colorant were added to the glass beaker. The beaker was then placed in a warm water bath to maintain the temperature at 50° C. 400 millimeter of demineralized water at 50° C. was placed in a 600-millimeter glass beaker and the mixture of fat phase and lecithin was added to the water and mixed using a mixer (Ultraturrax comprised of a module by Kinematica GmbH, Switzerland, Type RECO 20T, and a POLYTRON mixer Type PT 10/35 by Kinematica GmbH, Switzerland) for 2 minutes at 9900 rpm, which formed small droplets of an emulsino. This resulting emulsion was poured into a 500-millimeter graduated cylinder. The creaming of a dark red layer at the top of the cylinder was measured every 10 minutes for 1 hour. The results are shown in Table 1. TABLE 1 Time (minutes) Creaming (millimeter)  0 0 10 0 20 2 30 3 40 4 50 5 60 7 [0025] A standard of less than 15 millimeter creaming at 60 minutes indicates a good calf milk replacer. Therefore, the composition of the present invention is suitable for use as a calf milk replacer. [0026] The invention has been described with reference to various specific and illustrative embodiments and techniques. However, one skilled in the art will recognize that many variations and modifications may be made while remaining within the spirit and scope of the invention.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit of U.S. Provisional Patent Application No. 61/489,656, filed May 24, 2011. This application is incorporated herein by reference in its entirety. STATEMENT OF GOVERNMENT SUPPORT [0002] This invention was made with the support of government grant 1R01EY019287-01A1 from the National Institutes of Health. The government of the United States of America has certain rights in this invention. REFERENCE TO A SEQUENCE LISTING [0003] The Sequence Listing, which is a part of the present disclosure, includes a text file comprising primer nucleotide and/or amino acid sequences of the present invention. The subject matter of the Sequence Listing is incorporated herein by reference in its entirety. The information recorded in computer readable form is identical to the written sequence listing. INTRODUCTION [0004] There are a number of diseases that include or are characterized by inappropriate or pathological neovascularization. Among these diseases are diseases of the eye, such as diabetic retinopathy, retinopathy of prematurity, and choroidal neovascularization (CNV), i.e., the development of abnormal blood vessels underneath the retina which can occur in age-related macular degeneration (AMD). AMD is the leading cause of blindness and market size is currently about 4-6 billion USD. Only anti-VEGF approaches are currently available and efficacy has plateaued. [0005] AMD includes wet AMD and dry AMD. Blindness in AMD occurs largely from the exudative (wet) form of the disease that is characterized by the development of abnormal blood vessels underneath the retina, also called choroidal neovascularization (CNV) ( FIG. 7 a , arrows). In wet (exudative) AMD, blood vessels grow up from the choroid behind the retina, and the retina can become detached ( FIG. 7 a ). Senescent macrophages have been shown to polarize to a pro-angiogenic phenotype and promote the development of CNV. [0006] Wet AMD is preceded by non-exudative (dry) AMD. Dry or early AMD is diagnosed by the presence of lipid rich deposits called drusen that develop external to the retinal pigment epithelium (RPE) underneath the retina ( FIG. 7 b , arrows). In dry (non-exudative) AMD, the retina can also become detached. In the aged eye, alternatively activated macrophages can promote pathologic angiogenesis that can lead to blindness. Drusen are cardinal features of dry AMD. Progression of AMD is often characterized by increased size and number of drusen as well as softening of these deposits with associated detachment of the overlying retinal pigmented epithelium (RPE). Drusen have high lipid content and are rich in both esterified and unesterified cholesterol. These deposits with their high lipid content can serve as a nidus for inflammation. Macrophages have been shown to extend dendritic processes into drusen, and macrophage-mediated inflammation acclerates the development of the wet form of AMD by promoting blinding pathogenic neovascularization. Specifically, programmatic changes in macrophage activation associated with senescence polarize these cells to a proangiogenic or alternatively activated phenotype characterized by increased expression of IL-10 and decreased expression of IL-6 and Fas Ligand (FasL) among others. These alternatively activated macrophages promote the development of CNV that leads to progressive loss of vision. The precise mechanisms by which ‘old’ macrophages polarize to a pro-angiogenic phenotype are yet unknown. [0007] It has been hypothesized that high-density lipoprotein (HDL) metabolism is associated with CNV/AMD pathogenesis. However, data regarding the association between serum HDL levels and AMD are conflicting (The Eye Disease Case-Control Study Group, Arch. Ophthalmol 110:1701-1708 (1994), van Leeuwen, R., et al., Ophthalmology 111: 1169-1175 (2004); Wachter, A., et al., Ophthalmologe 101: 50-53 (2004); Delcourt, C., et al. Ophthalmic Epidemiol 8: 237-249 (2001); Nowak, M., et al. Clin Exp Med 4: 183-187 (2005); Abalain, J. H., et al., Clin Chim Acta 326: 97-104 (2002); Tan, J. S., et al., Ophthalmology 114: 1143-1150 (2007)). Some studies have shown an inverse relationship with either decreased HDL levels in AMD cases or decreased incidence of advanced AMD with higher HDL (Wachter, A., et al., Ophthalmologe 101: 50-53 (2004); Tan, J. S., et al., Ophthalmology 114: 1143-1150 (2007)). [0008] ABC (ATP binding cassette) transporters are a family of proteins that transport cholesterol out of macrophages and onto extracellular high density lipoprotein (HDL). Of the ABC family of proteins that regulate cholesterol efflux, ABCA1 (ATP binding cassette transporter A1) and ABCG1 (ATP blinding cassette transporter G1) are the most relevant to macrophage cholesterol efflux. ABCA1 promotes cholesterol efflux from cytoplasmic organelles such as lysosomes and the endoplasmic reticulum to the cell surface as well as to lipid poor apolipoprotein A-1 (apoA-1) in the extracellular compartment. ABCA1 regulated efflux of cholesterol out of cells leads to the formation of nascent high density lipoprotein (HDL) particles. ABCG1 can transport cholesterol from the macrophage cell membrane directly to HDL and can contribute to the formation of mature serum HDL. [0009] ABCA1 is the cAMP-inducible apolipoprotein receptor which mediates cholesterol secretion from macrophages (Oram, J. F., et al., J. Biol. Chem. 275: 34508-34511 (2000)). Tserentsoodol, N., et al., Mol Vis 12: 1319-1333 (2006) reported that intraretinal lipid transport is dependent on high density lipoprotein-like particles and class B scavenger receptors. Their study reported that ABCA1 as well as apoA1 are localized to the ganglion cell layer, retinal pigment epithelium (RPE), and rod photoreceptor inner segments. Furthermore, they found that lecithin:cholesterol acyltransferase (LCAT), and cholesteryl ester transfer protein (CETP) localizes mainly to the interphotoreceptor matrix (IPM). [0010] Liver X Receptors (LXRs) are nuclear receptors that play a central role in the control of lipid and carbohydrate metabolism as well as inflammation. Through the control of reverse cholesterol transport in macrophages, LXR ligands induce the expression of ABCA1, ABCG1, and ABCG4 transporters. In addition, LXRs promote the transcription of apolipoproteins ApoE and ApoC which act as cholesterol acceptors in macrophages. Moreover, LXRs positively regulate genes involved in lipoprotein remodeling such as lipoprotein lipase, CETP, and the phospholipid transfer protein (Gabbi, C., et al., Molec. Endocrin. 23: 129-136 (2009)). [0011] Tall, A. R., J. Internal Medicine 263 256-273 (2008) reported that plasma HDL levels exhibit an inverse relationship with atherosclerotic cardiovascular disease. This author speculates that the central anti-atherogenic activity of HDL is likely to be its ability to remove cholesterol and oxysterols from macrophage foam cells, smooth muscle cells and endothelial cells in the arterial wall. Furthermore, this author asserts that in cholesterol-loaded macrophages, activation of liver X receptors (LXRs) leads to increased expression of ABCA1, ABCG1 and apoE, and promotes cholesterol efflux. This author further reports that despite some recent setbacks in clinical investigations, there is still interest in therapeutically targeting HDL and macrophage cholesterol efflux pathways affecting atherosclerotic cardiovascular disease, via treatments with niacin, cholesterol ester transfer protein inhibitors, LXR activators and infusions of apoA-1, phospholipids and peptides. [0012] Cholesteryl ester transfer protein (CETP) is a plasma glycoprotein involved in reverse cholesterol transport (RCT), i.e., the transfer of cholesteryl esters from HDL to low density lipoprotein cholesterol (LDL) and very low density lipoprotein cholesterol (VLDL) (van der Velde, A., World J. Gastroenterol. 16(47): 5908-5915 (2010)). CETP activity can lead to lower levels of HDL while raising the levels of proatherogenic LDL and VLDL. CETP deficiencies in human populations have been associated with high levels of serum HDL. CETP is believed to influence macrophage cholesterol efflux indirectly by regulating the serum levels and stability of HDL particles. It is hypothesized to do so by facilitating the transport of cholesterol esters (CE) from HDL particles to low density lipoproteins (LDL) and very low density lipoproteins (VLDL) and in turn transporting triglycerides to HDL. The end result of this exchange can be the generation of unstable HDL. In macrophages from conditional ABCA1 −/− mice lacking the gene and protein only within macrophages, there is accumulation of free cholesterol (FC) within these cells. Intracellular accumulation of cholesterol at baseline and after stimulation of macrophages is also associated with increased lipid rafts in the plasma membrane and polarization of macrophages to a pro-inflammatory phenotype. [0013] While inhibition of CETP is considered a potential approach to treat atherosclerotic cardiovascular disease, negative phase III studies on clinical endpoints with the CETP inhibitor torcetrapib challenge the future perspectives of CETP inhibitors as potential therapeutic agents (Weber, O., et al., Cell. Mol. Life. Sci. 67: 3139-3149 (2010)). However, these studies involve systemic administration of CETP inhibitors. [0014] Genome wide association studies (GWAS) have identified single nucleotide polymorphisms (SNPs) in the innate immune system, specifically in the complement regulatory pathway that correlate with increased the risk of development and progression of AMD. GWAS have also demonstrated an association between SNPs in genes involved in cholesterol metabolism and advanced AMD. These include ABCA1, cholesterol esteryl transferase protein (CETP), hepatic triglyceride lipase C (LIPC) and lipoprotein lipase (LPL). Multivariate analyses have shown that allelic associations with advanced AMD are independent of actual serum HDL or lipid levels. It is thus apparent that the biologic pathways that connect macrophage-mediated inflammation, cholesterol regulation and age in AMD are highly complex and cannot be explained by a simple association of increased risk and abnormal serum lipid component levels. [0015] An analysis of SNPs by Chen, W., et al. (Proc. Nat'l Acad. Sci. USA 107: 7401-7406 (2010)) identified a susceptibility locus for AMD near TIMP3. In addition, their data revealed strong association signals with alleles at two loci: hepatic lipase (LIPC) and CETP. These loci were previously associated with high-density lipoprotein cholesterol (HDL-c) levels in blood. Consistent with a hypothesis that high-density lipoprotein (HDL) metabolism is associated with AMD pathogenesis, these workers observed an association with AMD of HDL-c-associated alleles near lipoprotein lipase (LPL) and ABCA1 genes. [0016] An analysis of SNPs by Neale, B. M., et al. (Proc. Nat'l Acad. Sci. USA 107: 7395-7400 (2010)) reported a significant association between advanced AMD and the hepatic lipase gene (LIPC) locus in their genome-wide association study. However, these workers found that previously reported results from HDL loci was inconsistent with a straightforward correlation between HDL levels and AMD. Data from their study suggested to these authors that the HDL-raising alleles of ABCA1 and CETP may increase the risk of AMD, although they did not consider their results as currently genome-wide significant. Thus, they concluded that the association between advanced AMD and LIPC may not represent a phenotypic correlation to, or a causal effect of, serum HDL but could indicate a shared underlying biologic mechanism involving the cholesterol pathway. [0017] An analysis of single-nucleotide polymorphisms (“SNPs”) by Yu, Y. et al., Invest Ophthalmol V is Sci. 2011 Mar. 29. [Epub ahead of print] indicated that loci LIPC and ABCA1 are related to intermediate and large drusen as well as advanced AMD. While Yu et al. report an inverse association between LIPC and ABCA1 with drusen, they speculate that is possible that functional variants regulating expression levels of LIPC and ABCA1 may promote cholesterol efflux, reduce the activation of the inflammatory pathway in subretinal macrophages and result in less drusen accumulation. Yu et al. further state that there is an allele in ABCA1 which decreases HDL levels and an allele in LIPC which increases HDL levels, and that both alleles are associated with decreasing risk of advanced AMD and drusen. [0018] There is no prior evidence that cholesterol regulation within macrophages affects angiogenesis within the eye and can affect outcomes in age-associated eye disease. There are currently no approaches that target cholesterol efflux as a mechanism to prevent blindness from wet AMD. The above-cited references do not teach that increasing cholesterol efflux from macrophages in the eye would provide an effective method of treating an ocular disease characterized by choroidal neovascularization such as AMD, nor do they teach that increasing ABC transporter expression or activity would provide an effective method of treating an ocular disease characterized by choroidal neovascularization such as AMD. SUMMARY [0019] The present inventor has demonstrated that as macrophages age, their ability to efflux cholesterol from the intracellular space declines. By using both gain of function and loss of function experiments, he has demonstrated that upregulation of the ABCA1 transporter protein on macrophages can alter macrophage polarization and protect against choroidal neovascularization (CNV) and blindness in age-associated eye disease. [0020] Macrophages from old mice have reduced ABC transporter expression, at the levels of both gene and protein expression, and can be unable to regulate CNV in eyes, unlike macrophages from young mice. In some configurations of the present teachings, treating old macrophages with agonists (LXR1) that can increase ABCA1 expression can alter macrophage activation and can restore their ability to regulate CNV. [0021] In some configurations, knockout mouse models of AMD, treatment with agonists that increase ABCA1, loss of function and gain of function experiments demonstrated the protective role of elevating ABCA1 in regulating angiogenesis in eye disease, and human data from patients and controls were used to demonstrate the translation of mouse findings in human disease. In some embodiments, simultaneous treatment with a PPAR agonist and LXR agonist (oxysterol) can have an additive effect on ABCA1 expression. [0022] The present teachings disclose methods of treating an ocular disease characterized by choroidal neovascularization (CNV) in a subject in need thereof. In some configurations, the methods comprise administering to the subject a therapeutically effective amount of an activator of an ATP-binding cassette (ABC) transporter. As used herein, an activator of an ABC transporter can be a compound that directly or indirectly increases expression or activity of an ABC transporter, such as, for example, an agonist for PPARα, PPARβ, or PPARδ (Borst, P., et al., Ann. Rev. Biochem. 71: 537-592 (2002); Chinetti, G., et al., Nat. Med. 7: 53-58 (2001); Oliver, W. R. J., et al., Proc. Nat'l. Acad. Sci. USA 98: 5306-5311 (2001) or an LXR agonist. In various configurations, the ABC transporter can be selected from the group consisting of ABCA1, ABCG1, and a combination thereof. [0023] In various embodiments, the activator of an ATP-binding cassette (ABC) transporter can be a compound that increases ABCA1 expression described in U.S. Pat. No. 7,579,504, U.S. Pat. No. 7,423,045, or U.S. Pat. No. 7,666,900. In various embodiments, the activator of an ATP-binding cassette (ABC) transporter can be an LXR agonist. In various embodiments, the LXR agonist can be selected from the group consisting of TO-901317 (CAS #: 293754-55-9; Synonym: N-(2,2,2-trifluoro-ethyl)-N-[4-(2,2,2-tri-fluoro-1-hydroxy-1-trifluoromethyl-ethyl)-phenyl]-benzenesulfonamide), N,N-dimethyl-3beta-hydroxy-cholenamide (DMHCA), methyl-3β-hydroxy-5α,6α-epoxycholanate (Yan, W., et al., Pharmacology 86: 306-312 (2010)), and GW3965 (2-[3-[3-[[2-chloro-3-(trifluoromethyl)phenyl]methyl-(2,2-diphenylethyl)amino]propoxy]phenyl]acetic acid). [0024] In various embodiments, the administering a therapeutically effective amount of an activator of an ABC transporter can comprise administering the activator intraocularly, periocularly or systemically. In various embodiments, the administering a therapeutically effective amount of an activator of an ABC transporter comprises administering to an eye of the subject a pharmaceutically acceptable eye drop formulation comprising the activator. In various embodiments, the administering a therapeutically effective amount of an activator of an ABC transporter comprises intraocularly can comprise injecting into an eye of a subject in need a pharmaceutically acceptable formulation comprising the activator. In some embodiments, the administering a therapeutically effective amount of an activator of an ABC transporter comprises administering the activator orally or parenterally in a pharmaceutically acceptable formulation. [0025] In various embodiments, the disease can be age-related macular degeneration (AMD). In various embodiments, the disease can be diabetes. In various embodiments, the disease can be a retinopathy of prematurity. [0026] In some configurations the methods comprise administering to a subject in need of treatment a therapeutically effective amount of an inhibitor of cholesteryl ester transfer protein (CETP) activity. In various embodiments, the inhibitor of CETP activity can be selected from the group consisting of Torcetrapib, Anacetrapib and Dalcetrapib. [0027] In some embodiments, the administering a therapeutically effective amount of an inhibitor of CETP activity can comprise administering the inhibitor intraocularly. In various embodiments, the administering a therapeutically effective amount of an inhibitor of CETP activity can comprise administering to an eye of the subject a pharmaceutically acceptable eye drop formulation comprising the inhibitor. In some embodiments, the administering a therapeutically effective amount of an inhibitor of CETP activity can comprise intraocularly injecting a pharmaceutically acceptable formulation comprising the inhibitor. In various embodiments, the administering a therapeutically effective amount of inhibitor of CETP activity can comprise administering the inhibitor orally or parenterally in a pharmaceutically acceptable formulation. [0028] In some configurations a method of the present teachings can comprise administering to a subject in need thereof a therapeutically effective amount of an inhibitor of cholesteryl ester transfer protein (CETP) gene expression. [0029] In various embodiments, the inhibitor of CETP gene expression can be an inhibitory RNA. In some embodiments, the inhibitory RNA can be an siRNA. In various embodiments, the inhibitor of CETP gene expression can be an inhibitory RNA. In some embodiments, the inhibitory RNA can be an miRNA. [0030] In various embodiments, the administering a therapeutically effective amount of an inhibitor of CETP gene expression can comprise administering the inhibitor intraocularly or periocularly. In some embodiments, the administering a therapeutically effective amount of an inhibitor of CETP gene expression can comprise administering to an eye of the subject a pharmaceutically acceptable eye drop formulation comprising the inhibitor. In various embodiments, the administering a therapeutically effective amount of an inhibitor of CETP gene expression can comprise intraocularly injecting a pharmaceutically acceptable formulation comprising the inhibitor. In various embodiments, the administering a therapeutically effective amount of an inhibitor of CETP gene expression can comprise administering the inhibitor orally or parenterally in a pharmaceutically acceptable formulation. [0031] In some configurations the methods can comprise, in order: a) providing a cell culture comprising macrophages; b) adding an activator of an ATP-binding cassette (ABC) transporter to the culture in an amount sufficient to stimulate ABC transporter expression and/or activity in the macrophages; and c) administering the macrophages to the subject. [0032] In some embodiments, the activator of an ATP-binding cassette (ABC) transporter can be an LXR activator. In various embodiments, the LXR activator can be N-(2,2,2-trifluoro-ethyl)-N-[4-(2,2,2-tri-fluoro-1-hydroxy-1-trifluoromethyl-ethyl)-phenyl]-benzenesulfonamide (CAS #: 293754-55-9). In various embodiments, the activator of an ATP-binding cassette (ABC) transporter can be a compound that increases ABCA1 expression described in U.S. Pat. No. 7,423,045. In various embodiments, the activator of an ATP-binding cassette (ABC) transporter can be an LXR agonist. In some embodiments, the LXR agonist can be selected from the group consisting of TO-901317 (CAS #: 293754-55-9; Synonym: N-(2,2,2-trifluoro-ethyl)-N-[4-(2,2,2-tri-fluoro-1-hydroxy-1-trifluoromethyl-ethyl)-phenyl]-benzenesulfonamide), methyl-3β-hydroxy-5α,6α-epoxycholanate (Yon, W., et al., Pharmacology 86: 306-312 (2010)), GW3965 (2-[3-[3-[[2-chloro-3-(trifluoromethyl)phenyl]methyl-(2,2-diphenylethyl)amino]propoxy]phenyl]acetic acid). [0033] In various embodiments, the providing a cell culture comprising macrophages comprises providing a cell culture comprising peripheral blood mononuclear cells (PBMCs). In some embodiments, the cell culture comprising PBMCs can comprise PBMCs autologous to the subject. In various embodiments, the providing a cell culture comprising macrophages can comprise growing macrophages comprised by the culture by methods known to skilled artisans, for example by the method of Bennett, S., et al., J. Immunol. Methods 153: 201-2-2 (1992). [0034] In some embodiments, the administering the macrophages to the subject can comprise administering the macrophages to the subject intravenously. In various embodiments, the administering the macrophages to the subject can comprise administering the macrophages to the subject periocularly. In various embodiments, the administering the macrophages to the subject comprises administering the macrophages to the subject intraocularly. [0035] In some embodiments, the present teaching include methods of treating an ocular disease characterized by choroidal neovascularization (CNV), comprising administering to a subject in need thereof a therapeutically effective amount of an inhibitor of miR33, such as, without limitation, a single-stranded RNA which specifically inhibits endogenous miR33 expression. In some configurations, the administering the inhibitor of miR33 can inhibit vascular endothelial cell proliferation. BRIEF DESCRIPTION OF THE DRAWINGS [0036] FIG. 1 illustrates age-associated decrease in gene expression of ABC transporters (ABCA1 and ABCG1) in senescent macrophages. [0037] FIG. 2 illustrates age associated impairment in macrophage cholesterol efflux capacities. [0038] FIG. 3 illustrates that the ability of macrophages to regulate vascular proliferation is altered by Abca1 deletion or cholesterol-rich diet. [0039] FIG. 4 illustrates that LXR agonist treatment restores the functional capacities of senescent macrophages. [0040] FIG. 5 illustrates age-related alteration of ABCA1 expression in human PBMCs. [0041] FIG. 6 illustrates MiR33 modulates macrophage regulation of vascular proliferation. [0042] FIG. 7 illustrates biomicroscopic findings in AMD. Clinical photograph of the retina of a patient with wet AMD (a) illustrates the development of CNV characterized by sub-retinal blood (arrow). An eye with dry AMD (b) demonstrates the presence of lipid rich drusen (arrow). [0043] FIG. 8 illustrates age-related alteration of macrophage ability to efflux cholesterol. [0044] FIG. 9 illustrates that the deletion of Abcg1 has no effect on macrophage-mediated regulation of vascular proliferation. [0045] FIG. 10 illustrates the effects of LXR agonist treatment on ABC transporter expression. [0046] FIG. 11 illustrates IL-10, ABCA1 and ABCG1 gene expression in human PBMCs of young and old donors. [0047] FIG. 12 illustrates Abca1 and Abcg1 promoter methylation in young and old macrophages. [0048] FIG. 13 illustrates the CNV complex. Cryostat section of eye with CNV and stained for H&E. DETAILED DESCRIPTION [0049] The present inventors have demonstrated that the cholesterol efflux regulators ABCA1 and ABCG1 are downregulated in macrophages with age in both mice and human. Age-associated downregulation of ABCA1 leads to alternative pro-angiogenic polarization of macrophages to an M2-like disease promoting phenotype. This is especially interesting in the light of previous studies that have shown that older mice have significantly higher volumes of CNV (Kelly, J., et al., J. Clin. Invest. 117, 3421-3426, 2007) after injury and that advanced AMD (van Leeuwen, R., et al., Epidemiology of age-related maculopathy: a review. Eur. J. Epidemiol. 18, 845-854, 2003) characterized by CNV only develops in individuals over 50 years of age. Using loss of function experiments with knockout mice, we have been able to demonstrate that macrophages deficient in ABCA1 are unable to regulate CNV in vivo and vascular endothelial cell proliferation in vitro. In essence, Abca1 −/− macrophages functionally behave like senescent macrophages isolated from mice at least 18 months of age. Of interest, loss of Abcg1 does not seem to affect the ability of these cells to regulate CNV or vascular endothelial proliferation suggesting a dominant role for ABCA1 in this process. A potential reason for the ABCA1 dominance in this process is the complete polarization of Abca1 −/− macrophages to an M2 phenotype identical to that seen in senescent macrophages that are unable to regulate aberrant angiogenesis. By contrast, Abcg1 −/− macrophages have a mixed phenotype, which may explain why they retain their functional abilities and do not demonstrate a programmatic shift to a senescent phenotype. It is also possible that ABCA1-driven efflux of intracellular cholesterol to the cell surface prior to deposition on to lipid-poor ApoA-1 is the critical pathway involved in the ability of macrophages to regulate aberrant and proliferative angiogenesis. [0050] Experiments in DIO mice have also provided insights in to the effects of cholesterol loading on macrophage function in the eye. Macrophages fed a high fat diet for a period of up to 6 months are unable to regulate CNV in vivo and vascular endothelial cell proliferation in vitro. These findings shed light on conflicting data from genetic and epidemiologic studies that demonstrate a complex association between polymorphisms in genes that regulate HDL and cholesterol metabolism and AMD as outlined above (Chen, W. et al. Genetic variants near TIMP3 and high-density lipoprotein-associated loci influence susceptibility to age-related macular degeneration. Proc Natl Acad Sci USA 107, 7401-7406, 2010; Neale, B. M. et al. Genome-wide association study of advanced age-related macular degeneration identifies a role of the hepatic lipase gene (LIPC). Proc. Natl. Acad. Sci. USA 107, 7395-7400, 2010). The data from knockout mice and the reduced expression of ABC transporters from old humans, diagnosed with AMD, suggest that local regulation of cholesterol efflux in the eye and the ability of macrophages to efficiently transport cholesterol from drusen to HDL and on to the systemic circulation are critical for the prevention of triggering of drusen-induced CNV in AMD. In older animals and humans, macrophages lose their ability to efflux cholesterol efficiently. This leads to alternative pro-angiogenic polarization of these cells, which in the appropriate genetic context of polymorphisms in complement regulatory genes (Edwards, A. O. et al. Complement factor H polymorphism and age-related macular degeneration. Science 308, 421-424, 2005) and alongside environmental cues such as smoking, can create a lethal micromilieu for the development and progression of advanced AMD where new blood vessels proliferate, cause bleeding and induce the formation of scar tissue that leads to photoreceptor loss and blindness. Our gain of function studies demonstrate that by upregulating ABC transporter expression in senescent macrophages using LXR agonists, we are able to restore their ability to inhibit vascular endothelial cell proliferation and CNV. In essence, LXR agonists are able to reverse the senescent phenotype and restore their angioregulatory function to levels comparable to mice that are significantly younger. [0051] Our work also reveals that upregulation of miR33 in aged macrophages might be responsible for the repression of ABCA1 that leads to defective cellular cholesterol metabolism in senescent macrophages. Indeed, antagonism of endogenous miR33 improves macrophage regulation of vascular proliferation. [0052] These results have significant therapeutic implications. CNV in AMD accounts for a large majority of blindness from this disease. Therapeutic intervention prior to the development of advanced disease with effective agents that upregulate macrophage cholesterol efflux in the eye can prevent progression and can be used as prophylaxis against the development of CNV and its blinding complications. The ability to deliver such therapies locally to the eye is a unique advantage in this immune privileged organ (Niederkorn, J. Y. See no evil, hear no evil, do no evil: the lessons of immune privilege. Nat. Immunol. 7, 354-359, 2006) and can be an effective barrier to off-target complications that are often seen with systemic therapy. [0053] Methods and compositions described herein utilize laboratory techniques well known to skilled artisans. Such techniques can be found in laboratory manuals such as Sambrook, J., et al., Molecular Cloning: A Laboratory Manual, 3rd ed. Cold Spring Harbor Laboratory Press, Cold Spring Harbor, N.Y., 2001; Spector, D. L. et al., Cells: A Laboratory Manual, Cold Spring Harbor Laboratory Press, Cold Spring Harbor, N.Y., 1998; Harlow, E., Using Antibodies: A Laboratory Manual, Cold Spring Harbor Laboratory Press, Cold Spring Harbor, N.Y., 1999; and Sioud, M., ed. Ribozymes and siRNA Protocols, New York, Springer-Verlag, 2004; Sohail, M., ed., Gene Silencing by RNA Interference: Technology and Application, CRC Press LLC, Boca Raton, Fla., 2005; Schepers, U., RNA Interference in Practice: Principles, Basics, and Methods for Gene Silencing in C. elegans, Drosophila , and Mammals, Wiley-VCH Verlag GmbH & Co., Weinheim 2005; and Engelke, D., RNA Interference (RNAi) Nuts & Bolts of RNAi Technology, DNA Press LLC, 2003. Methods of administration of pharmaceuticals and dosage regimes, can be determined according to standard principles of pharmacology well known skilled artisans, using methods provided by standard reference texts such as Remington: the Science and Practice of Pharmacy (Alfonso R. Gennaro ed. 19th ed. 1995); Hardman, J. G., et al., Goodman & Gilman's The Pharmacological Basis of Therapeutics, Ninth Edition, McGraw-Hill, 1996; and Rowe, R. C., et al., Handbook of Pharmaceutical Excipients, Fourth Edition, Pharmaceutical Press, 2003. Other techniques can be found in the references cited herein. In addition, the Examples may make use of the following materials and methods. [0054] Whole blood can be drawn from subjects by venipuncture using standardized phlebotomy procedures into 8-mL greencapped Vacutainers containing the anti-coagulant sodium heparin (Becton Dickinson, Franklin Lakes, N.J.). Plasma can be collected by centrifugation, aspirated and stored at −80° C. for later use. The plasma can be replaced with PBS and the blood resuspended and further diluted with an equal volume of PBS. PBMCs can be isolated by layering the diluted blood onto Ficoll-Paque PLUS (GE Healthcare), centrifuging for 22 min at 800 g, aspirating the PBMC layer and washing it once in PBS. The PBMCs (approximately 2×10 7 cells) can be centrifuged at 500 g for 7 min and either stored as frozen unactivated cells in 90% FBS and 10% DMSO at −80° C. for further culture and analysis or resuspended in TRIzol (Invitrogen, Grand Island, N.Y.) and stored at −80° C. for DNA and RNA extraction and analysis. [0055] Isolation, Separation and Culture of Primary Cells. Leukopaks of peripheral blood from subjects can be collected according to standard methods, such as a National Institutes of Health Clinical Center protocol NCT00001846. A subject's peripheral blood and plasma samples can be frozen according to standard methods. Mononuclear leukocytes can be isolated by Ficoll-Hypaque gradient centrifugation. The light density fraction (buffy coat) can be collected, and washed, for example twice with PBS. PBMC can be activated, e.g., by 1 μg/mL PHA (Abbott Diagnostics, Abbott Park, Ill.) and the cells can be cultured with 20 units/mL of IL-2 (Zeptometrix, Buffalo, N.Y.), M-CSF or GM-CSF and subcultured, e.g., every 3-5 days. For enrichment or isolation of macrophages, other cells can be removed using magnetic activated cell sorting (MACs) methods according to manufacturer's instructions (Miltenyi Biotec, Inc., Auburn, Calif.) and antibodies against cell-surface antigens not found on macrophages. After isolation or enrichment, macrophages can be cultured using a standard culture medium such asn RPMI-1640 medium supplemented with 10% fetal calf serum (FCS), 2 mM glutamine, 1 mM sodium pyruvate and antibiotics. Animals [0056] C57BL/6 mice (age <6 months), Diet Induced Obese mice (DIO) and age-matched controls were purchased from The Jackson Laboratory. C57BL/6 old mice (age >18 months) were purchased from National Institute of Aging. Macrophage-specific ABCA1 knockout mice (Abca1−/−) were generated by breeding Abca1 flox/flox mice, provided by Dr. John S Parks (Timmins, J. M. et al. Targeted inactivation of hepatic Abca1 causes profound hypoalphalipoproteinemia and kidney hypercatabolism of apoA-1. J Clin Invest 115, 1333-1342, 2005) with Lys-M Cre mice (The Jackson Laboratory, Bar Harbor, Me.). Previously characterized Abcg1−/− knockout mice (Baldan, A. et al. Deletion of the transmembrane transporter ABCG1 results in progressive pulmonary lipidosis. J. Biol. Chem. 281, 29401-29410, 2006); Kennedy, M. A. et al. ABCG1 has a critical role in mediating cholesterol efflux to HDL and preventing cellular lipid accumulation. Cell Metab. 1, 121-131, 2005) were provided by Dr. Angel Baldan. Cells [0057] Splenic macrophages were isolated by positive selection as previously described (Apte, R. S., et al., Macrophages Inhibit Neovascularization in a Murine Model of Age-Related Macular Degeneration. PLoS Med 3(8): e310. doi:10.1371/journal.pmed.0030310 2006). In brief, F4/80+ macrophages were purified from dissociated mouse spleen using magnetic separation (Stemcell Technologies Inc., Vancouver, BC Canada). Flow cytometry analysis of selected cell demonstrated cell purity greater than 90%. [0058] Peritoneal macrophages recruitment was elicited by intraperitoneal injection of 4% thioglycollate. Five days after injection, macrophages were harvested and cultured in RPMI-1640 overnight (Gibco, Grand Island, N.Y.). Macrophages were then washed with RPMI-1640 and non-adherent cells removed. [0059] Young or old mouse peripheral blood mononuclear cells (PBMCs) were prepared by centrifugation over Histopaque 1083 (Sigma-Aldrich) according to the manufacturer's instructions. [0060] Eye macrophages were isolated from CNV complexes by laser capture microdissection. Seven days after laser induction of CNV, mice were euthanized in a CO2 chamber, and their eyes were harvested for tissue processing. Eyes were cryoprotected in 1.5% sucrose, embedded in Tissue-Tek OCT compound (Sakura Finetek USA) and frozen. Cryostat sections, 12 μm thick, were mounted on PEN-Membrane slides (Leica Microsystems Inc., Buffalo Grove, Ill.). Sections were then incubated in absolute ethanol and briefly stained for H&E ( FIG. 13 ). In FIG. 13 , RPE: Retinal Pigment Epithelium; Macs: Macrophages; POS: Photoreceptors Outer Segments; ONL: Outer Nuclear Layer; ECs: Endothelial Cells. Scale bar, 100 μm. Single macrophages in CNV complexes were collected using Laser Microdissection System LMD6000 (Leica). Total RNA was extracted using the RNeasy mini kit (Qiagen). Human dermal microvascular endothelial cells (HMVECs) were purchased from Lonza (Basel, Switzerland) and cultured in EGM2V media. [0061] Human peripheral blood mononuclear cells were isolated from young (age range 25-34 years, n=9) or old (age range 67-87 years, n=9) donors diagnosed with neovascular AMD. This study was approved by the Human Research Protection Office of Washington University in St. Louis School of Medicine, and informed consent was obtained from all blood donors. PBMCs were purified by density gradient centrifugation using BD Vacutainer CPT according to the manufacturer's instructions (Becton Dickinson, Franklin Lakes, N.J.). PBMCs were resuspended and cultured in RPMI-1640 for 1 h and non-adherent cells were washed out. Real-time PCR and Gene Expression Analysis [0062] Total RNA was prepared from splenic macrophage, peritoneal macrophages, retina, choroid or PBMCs using the RNeasy mini kit (Qiagen Inc., Valencia, Calif.). cDNA was prepared using the High Capacity cDNA Archive Kit (Applied Biosystems) and PCR amplifications of cDNA were performed using Taqman probe-based gene expression assay (Applied Biosystems) as previously described (Kelly, J., et al., Senescence regulates macrophage activation and angiogenic fate at sites of tissue injury in mice. J Clin Invest 117, 3421-3426, 2007). Primer and probe sets were as follows: ActB, Mm00607939_s1; ABCA1, Mm00442649_m1; ABCG1, Mm01348250_m1; IL-6, Mm00446190_m1; FasL, Mm00438864_m1; IL-10, Mm99999062_m1; 18s rRNA, Hs99999901_s1; ABCA1, Hs00442663_m1; ABCG1: Hs 01555199_g1; IL10, Hs00961622_m1. Western Blot Analysis [0063] Whole cell lysate was extracted from mouse peritoneal macrophages or human PBMCs using lysis buffer (50 mM Tris (pH=7.4), 150 mM NaCl, 1% EDTA, 10% TritonX, and 1% SDS) with proteinase inihibitor (Complete, Roche). 20 mg lysates were resolved using NuPAGE gradient gels (Invitrogen) and electro-transferred to nitrocellulose membranes (Whatman) according to the manufacturer's instructions. Membranes were blocked in Odyssey Blocking Buffer (LI-COR Biosciences) for 1 h at room temperature then incubated with antibodies against ABCA1 (Timmins, J. M. et al. Targeted inactivation of hepatic Abca1 causes profound hypoalphalipoproteinemia and kidney hypercatabolism of apoA-I. J Clin Invest 115, 1333-1342, 2005), ABCG1 (Novus Biologicals) or β-Actin (Sigma-Aldrich, St. Louis, Mo.) in the same blocking buffer at 4° C. overnight. Blots were then washed and incubated with the secondary antibody conjugated to IRDye 800CW fluorophore (LI-COR Biosciences). Proteins were detected and analyzed using the Odyssey Infrared Imaging System (LI-COR Biosciences, Lincoln, Nebr.). Band densities of ABCA1 and ABCG1 were quantified and normalized to β-actin. Flow Cytometry [0064] Thioglycollate elicited peritoneal macrophages of young and old mice were rinsed in FACS buffer (0.1 mM EDTA, 2% FBS, PBS Mg/Ca free), permeabilized using 0.1% Triton X 100 in 1×PBS for 15 minutes and stained for either ABCA1 or ABCG1 along with isotype controls for 1 hour. After three washes, cells were incubated with FITC-conjugated secondary antibodies. Stained cells were then analyzed using Beckman Coulter flow cytometer (Beckman Coulter, Inc., Brea, Calif.). Oil Red O Staining [0065] Peritoneal macrophages were stained with Oil Red O Staining Kit, according to the manufacturer's instructions (Lifeline Cell Technology, Frederick, Md.). Cells were fixed with 4% PFA for 20 min and washed twice with deionized water. Dehydrated cells with 1,2 Propanediol were incubated with pre-warmed Oil Red O solution for 30 min at 37° C. Cells were then washed with 85% 1,2 Propanediol Stain Differential solution prior to examination by microscopy. Cholesterol Measurement [0066] Total cholesterol content of young and old peritoneal macrophages was quantified using the Amplex Red Cholesterol Assay Kit, according to the manufacturer's instructions (Molecular Probes). In brief, 50 μl of cell lysates (diluted in reaction buffer supplied in the assay kit) were incubated with. 50 μL of the Amplex Red reagent/HRP/cholesterol oxidase/cholesterol esterase solution for 30 min at 37° C. At different time points, cholesterol-associated fluorescence was measured and total cholesterol content was quantified using a cholesterol standard curve. For each sample, cellular protein content was determined and total cholesterol levels were represented as micrograms of total cholesterol per milligram of protein. OxLDL Uptake Assay [0067] Peritoneal macrophages isolated from young (<3 months) and old (>18 months) mice were plated on chamber slides and adherent cells were treated with 25 μg/ml Dil-oxydized LDL (oxLDL) for 24 hours (Intracel). After multiple washes, macrophages were incubated with fresh medium and Dil-oxLDL retention was examined using Zeiss LSM510 Confocal microscope. OxLDL Efflux Assay [0068] Young and old macrophages were preincubated for 3 hours with 25 μg/ml-DiI-oxLDL following which cells were further cultured for additional 21 hours and incubated in fresh media. Extruded Dil-oxLDL in the supernatant was analyzed and fluorescence was measured using 520 nm excitation and emission detection at 564 nm. Cholesterol Efflux Assay [0069] Thioglycollate-elicited peritoneal macrophage from young (<3 months) and old (>18 months) mice were incubated with 5 μCi/ml [3H]cholesterol-labeled oxLDL for 24 hours. Cells were then washed and equilibrated with 2 mg/ml BSA (Sigma-Aldrich) in media for 1 hour followed by incubation for 4 hours in media containing 10 μg/ml Human ApoA 1 or 50 μg/ml human HDL. Supernatants were collected and specific ApoA1/HDL-cholesterol efflux was expressed as a percentage relative to total radioactivity in cells and media. Cholesterol Sensing Assay [0070] Young and old macrophages were incubated with 25 oxLDL for 24 hours following which quantitative analysis of ABCA1 and ABCG1 gene expression by real time qPCR was assessed as described above. Vascular Endothelial Cell Proliferation Assay [0071] Cell proliferation was measured with an adaptation of a previously described method (Khan, A. A. & Apte, R. S. An assay for macrophage-mediated regulation of endothelial cell proliferation. Immunobiology 213, 695-699, 2008). HMVECs (1×10 4 cells) in log phase were cultured in 96-well round-bottomed plates for adherence. HMVECS cells were then co-cultured with peritoneal macrophages (1:25 ratio) and incubated with 5 μCi/ml [ 3 H] thymidine (PerkinElmer) for 24 hours. Cells were harvested onto glass fiber filters (Packard) and incorporated [3H] thymidine was read using ToPCount NXT (PerkinElmer). Laser-Induced CNV in Mice [0072] Rupture of Bruchs membrane with laser was used to initiate CNV in mice as described previously (Apte R S, Niederkorn J Y. Isolation and characterization of a unique natural killer cell inhibitory factor present in the anterior chamber of the eye. J. Immunol. 156:2667-2673, 1996). Briefly, mice were anesthetized by injecting ketamine hydrochloride (100 mg/kg) and xylazine (13.4 mg/kg) intraperitoneally, and their pupils were dilated with 1% tropicamide. Using argon green laser, four laser burns were placed around the optic nerve (0.1 second, 50 μm, and 110 mW). Seven days after laser, mice were anesthetized as described above and perfused intraventricularly with FITC-dextran (Sigma-Aldrich). Mice were euthanized in a CO2 chamber, and their eyes were harvested for tissue processing. A dissecting microscope was used to remove the cornea and lens and to gently separate the retina from the underlying choroid and sclera. [0073] Micro scissors were used to make four radial incisions in the sclerochoroidal “eyecup” to prepare choroidal flat mounts on glass slides. The tissues were incubated in 4% paraformaldehyde for 45 min and washed 3 times with 3% bovine serum albumin. The choroidal flat mounts were analyzed for the presence of CNV by confocal microscopy. The extent of choroidal neovascularization was quantified by Metamorph Imaging software. We used n>5 mice for each group. [0000] Treatment LXR agonist [0074] Young and old peritoneal macrophages were treated with Liver X Receptor (LXR) agonist, TO-901317 (Sigma-Aldrich, St. Louis, Mo.) for 24 hours. LXR agonist was dissolved in DMSO (vehicle) and treatment dosage ranged from 0 to 10 Treated macrophages were analyzed for ABCA1 and ABCG1 gene expression and their ability to inhibit HMVECs proliferation was tested. [0075] Old mice (>18 months) were given a daily intraperitoneal injection of vehicle, 25 mg/kg or 50 mg/kg TO-901317. After five consecutive days treatment, CNV was induced in one set of mice (5 of each group) and analyzed as described above. The second set of mice (3 of each group) was sacrificed for ABCA1 and ABCG1 gene and protein expression analysis in retina, choroid, peritoneal macrophages, brain and liver. Oxysterol Determinations [0076] Oxysterols were extracted from RPMI-1640 culture media of young or old peritoneal macrophages and determinations of 27-hydroxycholesterol (27-HC) and 7-ketocholesterol (7-KC) were performed as previously described (Jiang, X. et al. A sensitive and specific LC-MS/MS method for rapid diagnosis of Niemann-Pick C1 disease from human plasma. J. Lipid Res. 52, 1435-1445, 2011). 27-HC and 7-KC measurements were normalized to total proteins extracted from young or old macrophages. MicroRNA Quantification [0077] Total miRNA was isolated from peritoneal macrophages using mirVana kit (Ambion) and reverse transcribed with the RT 2 miRNA First Strand Kit (SABioscience). PCR amplifications of cDNA were performed using RT 2 SYBR Green qPCR (SABioscience) with specific primers for quantification of mouse miR33 and normalized to U6 as housekeeping gene. MiR33 Transfection [0078] Peritoneal macrophages were transfected with 50 nM miScript miR33 inhibitor (anti-miR33) or negative control inhibitor (con anti-miR) using HiPerFect Transfection reagent (Qiagen). The transfection efficiency of macrophages was assessed using BLOCK-iT Fluorescent Oligo (Invitrogen). After miR33 inhibition, target genes and proteins were analyzed by qPCR and Western blot. DNA Methylation Analysis [0079] DNA samples were bisulfite modified using the Epitect Bisulfite kit (Qiagen) to convert unmethylated cytosines into uracils. CpG methylation was determined by Sanger sequencing the bisulfite-modified using ABI Prism Dye Terminator BigDy kit (Applied Biosystems) with the following primers: ABCA1 forward—GAAGGTTAGTAGGTTAGGGTTAGGG (SEQ ID NO:1); ABCA1 reverse—AAAAACAAAAAACAAAACAACTCCC (SEQ ID NO:2); ABCG1 forward—GGGTTGAGTTGGTTTAGTTTTTGTA (SEQ ID NO:3); ABCG1 reverse—ACAAACACACCCATCTTCAACTAAT (SEQ ID NO:4). Sequence data was interpreted using Sequencer software (Gene Codes Corp., Ann Arbor, Mich.). Statistics [0080] Statistical analysis was determined by 2-tailed Student's t test and ANOVA with the use of GraphPad Prism Software. Results are presented as mean±SEM. Statistical significance was defined at P<0.05. EXAMPLES [0081] The present teachings including descriptions provided in the Examples that are not intended to limit the scope of any claim or aspect. Unless specifically presented in the past tense, an example can be a prophetic or an actual example. The following non-limiting examples are provided to further illustrate the present teachings. Those of skill in the art, in light of the present disclosure, will appreciate that many changes can be made in the specific embodiments that are disclosed and still obtain a like or similar result without departing from the spirit and scope of the present teachings. Example 1 [0082] This example illustrates effects of age on cholesterol efflux. [0083] To determine whether age altered cholesterol efflux in macrophages, we analyzed the expression patterns of ABCA1 and ABCG1 in these cells. Quantitative analysis of gene expression by real time PCR demonstrated an age-associated reduction in levels of ABCA1 and ABCG1 expression in splenic, peritoneal and eye macrophages and PBMCs ( FIG. 1 a - d ). Analysis of ABCA1 and ABCG1 protein levels in peritoneal macrophages isolated from either young (<3 months) or old (>18 months) mice by western blotting as well as flow cytometry confirmed that reduced gene expression of ABCA1 and ABCG1 with age translated to reduced protein expression ( FIG. 1 e - f ). [0084] Because of the critical role of ABC transporters in lipid metabolism in macrophages, we examined whether the age-associated decrease of ABCA1 and ABCG1 altered the intracellular lipid load within macrophages and influenced formation of foam cells. Thioglycollate elicited young or old peritoneal macrophages were stained with Oil red O to visualize foam cells ( FIG. 2 a , arrow). Quantitative analysis of lipid-laden macrophages showed that foamy macrophages were more frequent in peritoneal macrophages collected from old mice as compared to young mice ( FIG. 2 b ). Subsequent quantification of total cholesterol content by fluorometry confirmed the significantly increased accumulation of cholesterol in old macrophages compared to their young counterparts (21.95±0.15 vs 14.90±0.10, p<0.001) ( FIG. 2 c ). [0085] To test whether the senescence-associated decrease of ABC transporters affected the cholesterol efflux efficiency in macrophages, we assessed the ability of peritoneal macrophages to effectively internalize, retain and subsequently efflux lipids from oxidized low-density lipoproteins (oxLDL). Thioglycollate elicited young or old peritoneal macrophages were incubated with Dil-oxLDL for 24 hours following which cells were washed and incubated in fresh media. Intracellular accumulation of Dil-oxLDL was then examined by confocal microscopy. Macrophages from old mice had higher levels of intracellular oxLDL compared to macrophages from young mice ( FIG. 2 d ). [0086] In order to assess their abilities to efflux lipids, young and old macrophages were incubated with Dil-oxLDL for 3 hours following which cells were washed and incubated in fresh media for an additional 21 hours. There was no difference in the level of internalized oxLDL in young as compared to old macrophage examined by fluorescence microscopy immediately after 3 hours of incubation confirming that the influx capacity of old macrophages was not altered. However, quantitative analysis of the extruded oxLDL content showed significantly higher levels in supernatants of young macrophages compared to old cells ( FIG. 8 ). As Dil-oxLDL is not a direct and specific measure of cholesterol efflux, we next analyzed specific cholesterol efflux of young and old macrophages, preloaded with [3H] cholesterol using ApoA1 and HDL as carriers. Macrophages were incubated with 5 μCi/ml [3H]cholesterol-labeled oxLDL for 24 hours. Cells were washed and equilibrated for 1 hour followed by incubation for 4 hours in media containing ApoA1 or HDL. Consistent with the results above, we demonstrate that cholesterol efflux is significantly reduced in old macrophages ( FIG. 2 e ). Taken together, our findings demonstrate that reduced expression of ABC transporters in old macrophages impairs their ability to effectively efflux cholesterol. [0087] It has been previously demonstrated that macrophages can sense alterations in extracellular cholesterol levels and effectively modulate levels of ABC transporters (Repa, J. J. et al. Regulation of absorption and ABC1-mediated efflux of cholesterol by RXR heterodimers. Science 289, 1524-1529, 2000). We next investigated the effect of cholesterol treatment on the expression patterns of ABCA1/G1 in young or old macrophages. Young macrophages demonstrated a robust increase in expression of both ABCA1 and G1 after incubation with oxLDL, while old macrophages were significantly impaired in their ability to do so ( FIG. 2 f - g ). These findings confirm that senescent macrophages not only have reduced cholesterol efflux capacities, but also are unable to respond to exogenous lipid as efficiently as young macrophages. Example 2 [0088] This example illustrates that Abca1 depletion affects macrophage regulation of vascular endothelial cell proliferation and pathological angiogenesis. [0089] To determine the contribution of individual ABC transporters in age-associated dysfunction of macrophage cholesterol homeostasis, we investigated the effects of selective Abca1 or Abcg1 deletion on effector function. Recent studies have demonstrated that macrophage polarization can play a pivotal role in determining their ultimate effector functions including their ability to regulate angiogenesis (Macrophages Inhibit Neovascularization in a Murine Model of Age-Related Macular Degeneration. PLoS Med 3(8): e310. doi:10.1371/journal.pmed.0030310 2006; Kelly, J., et al., Senescence regulates macrophage activation and angiogenic fate at sites of tissue injury in mice. J. Clin. Invest. 117, 3421-3426, 2007; Mosser, D. M. The many faces of macrophage activation. J. Leukoc. Biol. 73, 209-212, 2003; Mantovani, A., et al., Macrophage polarization comes of age. Immunity 23, 344-346, 2005). To determine whether Abca1 or Abcg1 deletion affected macrophage polarization, we analyzed the cytokine gene expression patterns of peritoneal macrophages isolated from young wt, Abca1 −/− or Abcg1 −/− mice by quantitative real time PCR. Loss of Abca1 was associated with a significant decrease in IL-6 and FasL expression and an upregulation of IL-10 expression, consistent with an alternatively activated phenotype ( FIG. 3 a ). Expression levels of TNF-α and IL-12 were not altered. As previously shown, this cytokine signature is characteristic of pro-angiogenic macrophages (Macrophages Inhibit Neovascularization in a Murine Model of Age-Related Macular Degeneration. PLoS Med 3(8): e310. doi:10.1371/journal.pmed.0030310 2006; Mosser, D. M. The many faces of macrophage activation. J. Leukoc. Biol. 73, 209-212, 2003; Mantovani, A., et al., Macrophage polarization comes of age. Immunity 23, 344-346, 2005). In contrast, loss of Abcg1 had no effect on global macrophage polarization to either classical or alternatively activated cells as both IL-6 and IL-10 gene expression were reduced significantly without any associated change in FasL expression ( FIG. 9 a ). [0090] FIG. 9 illustrates that the deletion of Abcg1 has no effect on macrophage-mediated regulation of vascular proliferation. (a) Quantitative mRNA analysis of IL-6, FasL and IL-10 in wt (Abcg1+/+) and ABCG1-deficient (Abcg1−/−) macrophages. (b) Assessment of the ability of Abcg1+/+ or Abcg1−/− macrophages to inhibit proliferation of HMVECs. Laser-induced CNV in Abcg1+/+ or Abcg1−/− mice was examined by confocal microscopy (c) and CNV (white circle) volume quantified (d). Statistically significant difference **P<0.01, ***P<0.001. [0091] Next, we investigated the ability of Abca1 −/− and Abcg1 −/− macrophages to inhibit vascular endothelial cell proliferation in vitro using HMVECs and to regulate pathologic angiogenesis in vivo using the injury-induced CNV assay as described previously and in Methods (Kelly, J., et al., Senescence regulates macrophage activation and angiogenic fate at sites of tissue injury in mice. J. Clin. Invest. 117, 3421-3426, 2007). In co-cultures, Abca1 −/− macrophages from young mice lost their ability to inhibit HMVECs proliferation as compared to macrophages from age-matched wt mice or from Abcg1−/− young macrophages ( FIG. 3 b and FIG. 9 b ). These results combined with previous findings that old macrophages lose the ability to regulate vascular proliferation and CNV suggest that Abca1 −/− macrophages demonstrate an accelerated senescence program. We investigated this in vivo in the injury-induced CNV model. As anticipated, CNV volumes were significantly higher in mice whose macrophages were deficient in Abca1 as compared to wild type littermates ( FIG. 3 c - d ). In contrast, CNV volumes in Abcg1 −/− mice were comparable to littermate controls confirming an ability of these cells to inhibit CNV ( FIG. 9 c - d ). These results demonstrate that ABCA1 is the primary regulator of macrophage polarization and that ‘young’ macrophages lacking Abca1 have the same cytokine polarization and functional deficits i.e. pro-angiogenic behavior as ‘old’ wild type macrophages. Example 3 [0092] This example illustrates that a cholesterol-rich diet accelerates a senescent macrophage phenotype. [0093] As shown in FIG. 2 , ABCA1/G1 transporters within macrophages regulate intracellular cholesterol efflux. We next investigated the effect of chronic dietary lipid/cholesterol burden on macrophage function using diet-induced obesity (DIO) mice as a model of high fat/cholesterol fed mice. Quantitative analysis of intracellular cholesterol content demonstrated that DIO macrophages had significantly higher levels of total cholesterol compared to age-matched controls at both 3 and 6 months of age ( FIG. 3 e ). To determine whether high fat/cholesterol stress altered the ability of DIO macrophages to regulate vascular proliferation, we incubated young DIO macrophages with HMVECs and assessed their proliferation. DIO macrophages were unable to inhibit HMVECs proliferation ( FIG. 3 f ). In addition, DIO macrophages demonstrated an impaired ability to regulate CNV in vivo ( FIG. 3 g - h ) indicating that chronic fat/cholesterol stress can impair the ability of macrophages from young mice to regulate pathological vascular proliferation and angiogenesis. These data also suggest that higher dietary lipid can potentially accelerate the programmatic changes associated with senescence within macrophages. Example 4 [0094] This example illustrates that LXR agonists restore in senescent macrophages their functional capacity to regulate pathological angiogenesis. [0095] Our data show that age-associated reduction in expression of ABC transporters impairs the efflux capacity of macrophages and results in increased cholesterol accumulation. Loss of Abca1 also translated into a loss of the ability of these cells to regulate angiogenesis. We therefore investigated whether restoring the efflux capacity of macrophages in old mice could improve their effector functions. Recent studies have shown that transcriptional nuclear receptors such as Liver X Receptors (LXRs) were direct enhancers of ABC transporters expression in macrophages (Repa, J. J., et al., Regulation of absorption and ABC1-mediated efflux of cholesterol by RXR heterodimers. Science 289, 1524-1529, 2000). [0096] Treatment of peritoneal young or old macrophages with LXRs synthetic agonist (TO-901317, Cayman Chemical Company Ann Arbor, Mich.) induced a dose-dependent up-regulation of both ABCA1 and ABCG1 gene expression ( FIG. 4 a - b ). Importantly, this ligand-dependent increase of ABC transporters was higher in old macrophages suggesting retained responsiveness of old macrophages to LXR agonists despite low baseline levels of ABCA1/G1 expression (as shown in FIG. 1 a - d ) allowing old cells to reach the expression levels of ABCA1 and ABCG1 comparable to that seen in young macrophages. Although the ability of old macrophages to upregulate ABCA1/G1 transporter expression in response to exogenous cholesterol (oxLDL) was dampened as seen in FIG. 2 f - g , they were able to respond robustly to direct LXR stimulation by synthetic ligand (TO-901317). [0097] It has been previously demonstrated that LXR can be regulated by endogenously-synthesized cholesterol oxidation products (oxysterols) such as 27-hydroxycholesterol (27-HC) or non-oxysterol mediators (TO-901317) (Repa, J. J., et al., Regulation of absorption and ABC1-Mediated efflux of cholesterol by RXR heterodimers. Science 289, 1524-1529, 2000; Janowski, B. A., et al., An oxysterol signalling pathway mediated by the nuclear receptor LXR alpha. Nature 383, 728-731, 1996; Repa, J. J. & Mangelsdorf, D. J. Nuclear receptor regulation of cholesterol and bile acid metabolism. Curr. Opin. Biotechnol. 10, 557-563, 1999). [0098] An analysis of baseline cell-associated oxysterol content of young and old macrophages at baseline showed a 2-fold increase in 27-HC in old macrophages ( FIG. 4 c ). The increase in 27-HC was accompanied by a commensurate 2-fold increase in 7-ketocholesterol (7-KC). While 27-HC is an activator of the LXR pathway (Fu, X. et al. 27-hydroxycholesterol is an endogenous ligand for liver X receptor in cholesterol-loaded cells. J. Biol. Chem. 276, 38378-38387, 2001), numerous studies have shown that 7-KC can effectively interfere with LXR activation and cholesterol efflux (Gelissen, I. C. et al. Sterol efflux is impaired from macrophage foam cells selectively enriched with 7-ketocholesterol. J. Biol. Chem. 271, 17852-17860, 1996; Gelissen, I. C., et al., Oxysterol efflux from macrophage foam cells: the essential role of acceptor phospholipid. J. Lipid Res. 40, 1636-1646, 1999; Kritharides, L., et al., Apolipoprotein A-I-mediated efflux of sterols from oxidized LDL-loaded macrophages. Arterioscler. Thromb. Vasc. Biol. 15, 276-289, 1995). As seen in FIG. 4 c , the absolute increase in 7-KC levels was 17-fold greater than that of 27-HC, offering a possible explanation as to why old macrophages are unable to respond as efficiently to exogenous cholesterol stimulation but respond robustly to synthetic agonists. These data suggest the possibility of reversing some of the programmatic dysfunctionality seen in these cells with age. [0099] In order to confirm this hypothesis, we co-cultured LXR agonist (TO-901317)-treated young or old macrophages with HMVECs and analyzed their ability to inhibit endothelial cell proliferation. As shown in FIG. 4 d , LXR agonist treatment of old macrophages completely restored their ability to inhibit endothelial cell proliferation. Treatment of Abca1 −/− macrophage with LXR agonist does not restore their ability to inhibit HMVECs proliferation. These results confirm that downregulation of ABCA1 (not ABCG1) is the basis of the impaired function observed in old macrophages. [0100] Old mice were then treated with intraperitoneal injections of vehicle (DMSO) or TO-901317 at 25 or 50 mg/kg/day for 5 days prior laser induction of CNV. Quantitative analysis of gene expression showed that treated mice at both doses had strong systemic upregulation of ABCA1 and ABCG1 expression compared to vehicle treated mice ( FIG. 4 e - g and FIG. 10 ). [0101] FIG. 10 illustrates the effects of LXR agonist treatment on ABC transporter expression. Quantitative analysis of mRNA levels of ABCA1 and ABCG1 in brain (a) and liver (b) of old mice, treated for 5 days with vehicle, 25 mg/kg or 50 mg/kg of TO-901317. Statistically significant difference *P<0.05, **P<0.01, ***P<0.001, compared to vehicle treatment. [0102] In addition, LXR-agonist treatment of old mice resulted in a significant and dose dependent reduction in CNV compared to vehicle treated old mice thus restoring their functional capacity to regulate pathological vascular proliferation ( FIG. 4 h - i ). Taken together, these results conclusively demonstrate that LXR agonists restore in old macrophages effector capabilities that are similar to those observed in young macrophages. Example 5 [0103] This example illustrates age-related reduction of ABCA1 expression in human PBMCs. [0104] The above data demonstrate that senescent macrophages have impaired cholesterol efflux capacities that lead to a loss of their ability to regulate vascular proliferation. This impairment in macrophage function is associated with a loss of ABCA1. We next investigated the expression levels of ABCA1/G1 in PBMCs isolated from young (age range 25-34 years, n=9) and old (age range 67-87 years, n=9) donors. In these experiments, total protein extracts were analyzed for ABCA1/G1 expression and representative immunoblots are shown in FIG. 5 a . Densitometric analysis normalized to β-actin expression showed that ABCA1 expression level was significantly reduced in old compared to young donors while ABCG1 protein expression was unchanged ( FIG. 5 b - c ). These findings are consistent with quantitative gene expression analysis demonstrating that ABCA1 gene expression was 2.5 fold lower in old donors while ABCG1 expression was not significantly different ( FIG. 11 b - c ). In addition, PBMCs from old donors had higher levels of IL-10 expression compared to young, confirming their phenotype as alternatively activated cells ( FIG. 11 a ). Immunohistochemistry of a CNV membrane isolated from a patient during sub-retinal surgery confirmed the presence of CD68 positive macrophages that have reduced ABCA1 expression when compared to other cell types within the lesion ( FIG. 5 d , arrows). Example 6 [0105] This example illustrates age-related overexpression of Mir33 repressed macrophage regulation of vascular proliferation. [0106] We have shown that aging altered macrophage expression of ABCA1 and ABCG1 that resulted in defective cholesterol efflux and subsequent impairment in their capacity to regulate pathological angiogenesis. We next investigated the mechanisms that led to the age-associated decline in the expression of ABC transporters. To determine whether epigenetic mechanisms were involved in this process, the methylation pattern of Abca1 and Abcg1 promoters by bisulfite modified CpG Sanger sequencing. There was no significant difference in the frequency or pattern of methylation of the promoter regions of these genes between young and old macrophages ( FIG. 12 ). Recent studies have shown that a highly conserved microRNA, miR33 regulates the expression of genes involved in cellular cholesterol metabolism, among them ABCA1 and ABCG1 (Najafi-Shoushtari, S. H. et al. MicroRNA-33 and the SREBP host genes cooperate to control cholesterol homeostasis. Science 328, 1566-1569, 2010; Rayner, K. J. et al. MiR-33 contributes to the regulation of cholesterol homeostasis. Science 328, 1570-1573, 2010; Marquart, T. J., et al., miR-33 links SREBP-2 induction to repression of sterol transporters. Proc. Natl. Acad. Sci. USA 107, 12228-12232, 2010; Rayner, K. J. et al. Antagonism of miR-33 in mice promotes reverse cholesterol transport and regression of atherosclerosis. J. Clin. Invest. 121, 2921-2931, 2011). We next examined miR33 expression in young and old macrophages. As shown in FIG. 6 a , miR33 expression was significantly higher in old macrophages as compared to young, consistent with reduced expression of ABCA1 and ABCG1 observed in aged macrophages. [0107] Based on these findings, we hypothesized that antagonism of tniR33 in macrophages might enhance their regulation of vascular proliferation. Macrophages were transfected with miR33 inhibitor (anti-miR33) or negative control inhibitor (con anti-miR) and expression of ABC transporters expression was assessed. Efficacy of microRNA transfection was confirmed using fluorescent RNA oligomer as shown in FIG. 6 b . Inhibition of miR33 resulted in a significant increase in mRNA and protein levels of both ABCA1 and ABCG1 ( FIG. 6 c - d ). In addition, antagonism of endogenous miR33 improved the ability of macrophages to inhibit vascular endothelial cell proliferation ( FIG. 6 e ). [0108] References cited herein are incorporated by reference, each in its entirety.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates to educational and amusement devices or games and more particularly to a geographical air travel game played upon a game board. 2. Description of the Prior Art Various games relating to airline travel and played upon a game board are known to the prior art. For example, U.S. Pat. No. 1,609,262 discloses an air travel game in which miniature airplanes are insertable by means of pins mounted thereon into a cork base designating a geographic location. Printed instructions are applicable to each location. A roll of the dice determines the distance to be moved. The first player to circle the glove and return to the starting point wins the game. No skill or discretion on the part of the players is involved, just mere chance. U.S. Pat. No. 3,467,387 has as its object a predetermined total of financial possessions of visited locations. The game uses several decks of cards to accomplish its objective. U.S. Pat. No. 3,726,527 is similar to the immediate above but more complicated in requiring business judgement and knowledge. U.S. Pat. Nos. 3,638,946; 3,658,337; and 3,883,142 disclose other board game devices which are of interest in involving game boards and various modes of transportation moving about them, e.g., car, airplane, boat, even walking. None of the foregoing, as will be seen, discloses the present inventive combination. SUMMARY OF THE INVENTION It is, therefore, among the principal objectives of this invention to provide a board game apparatus improved over the prior art both in skill and amusement as well as in educational value. The objective of this invention game is twofold: (1) arrive at your destination first; and (2) score the most points. Both criteria must be achieved in order to be the winner. The game apparatus includes a game board illustrating a map of the United States designating certain cities connected by color coded airplane flight routes, an equal number of checkpoints on each flight route identifying the location of each flight at all tims, alternate flight routes being provided for each flight in the same color coding aforementioned, not necessarily the same number of checkpoints on each alternate flight leg; a chance number indicator such as a pair of dice; color coded miniature jet airplane markers; color coded board markers; a plurality of randomly sortable "Airmanship Cards," "Decision Cards," and "Enroute Cards." This game is played with two types of markers; miniature jet airplane markers that move across the jet routes on the map and show the location of each flight at all times, and board markers that move around the border of the game board based on rolls of the dice. The board markers, together with Airmanship, Decision and Enroute Cards described below, determine the progress of each jetliner towards its destination. Each of the four jet routes, airplane markers and board markers are color coded for identification. Various blocks around the border of the game board are color-coded to the colors of the various flights. When a player's board marker lands on a block of the same color, the player advances his aircraft the number of checkpoints specified on that block. Airmanship Cards describe various situations encountered by each player as "Captain" of his/her flight and are self-explanatory. Airmanship Cards are "points" type cards and do not affect the progress of the flight towards its destination. Decision Cards offer alternative decisions to the "Captain" that affect both points and progress of the flight. Enroute Cards can affect both progress of the flight and points scored (or lost) enroute to your destination and are based on a variety of situations encountered by the "Captain" (pilot). Checkpoints are used by pilots to establish their position over the surface of the earth at all times. Pilots of modern day jetliners do not need to see the ground to know where they are. Modern jetliners utilize "electronic" checkpoints that register on instruments in the cockpit. For the purposes of this game, checkpoints are represented by the short lines drawn perpendicular to the route. The distances (checkpoints) from the originating airports to the intended destination airports are the same for all flights. However, the distances from the original destination airports to the alternate destination airports vary somewhat. Consequently, it may be advisable to select the flight with the shortest distance to its alternate airport in the event the flight should have to continue to its alternate airport. BRIEF DESCRIPTION OF THE DRAWING The invention will be hereinafter more fully described with reference to the accompanying drawing, in which: FIG. 1 is a plan view of the playing board illustrating the map of the United States with flight routes and alternate routes shown, and indicating the various border marker positions; FIG. 2 is a plan view of a pair of dice used to determine the length of a move for the player along the border positions; FIG. 3 is a top plan view of a miniature jet airplane marker; and FIG. 4 is a perspective view of a border marker. DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring now to the figures of the drawing there is shown therein a game board 10 showing a map 12 of the United States (except in Hawaii and Alaska). The flight routes are designated as Spokane-Chicago-New York, color coded red and signified by the reference numeral 14; Pittsburgh-St. Louis-San Francisco, color coded blue and signified by the reference numeral 16; Los Angeles-Oklahoma City-Miami, color coded yellow and signified by the reference numeral 18; Miami-Houston-Los Angeles, color coded green and signified by the reference numeral 20. Each flight has the same number of checkpoints 19 (drawn perpendicular to the route) which in this instance are 30 in number (this can vary as can color codings). Each flight has a predetermined alternate destination in keeping with good safety precautions practiced by all major airlines. To wit, red flight's alternate is Richmond 14a; blue's is Portland 16a; yellow's is Atlanta 18a; and Green's is San Francisco 20a. As mentioned earlier, the numbers of checkpoints for the alternate flights are not necessarily the same. Game board 10 has all four borders marked off in boxes numbering 40 in all, 12 each on the top and bottom borders, and 8 each on the side borders. Each box has a number designated therein, which number specifies specific instructions pertaining thereto. Table I immediately hereinbelow collates these box numbers with their specific instructions in the manner according to the invention. TABLE I 21 foul Weather Lose Next Turn 22 Advance 1 Check Point 23 Advance two Check Points 24 Airmanship Take 1 Card 25 Airmanship Take 2 Cards 26 Special Air Traffic Clearance Advance 2 Check Points 27 Decision Take 1 Card 28 Decision Take 2 Cards 29 Enroute Take 2 Cards 30 Exceptional Blind Flying Ability Advance 3 Check Points or Score 30 Points 31 Enroute Take 1 Card 32 Bomb Scare Lose Next Turn 33 Won Air Safety Award Score 25 Points 34 Roll 10 or Higher to Advance 3 Check Points 35 Excellent Technique Advance 2 Check Points or Score 20 Points 36 Saw Flying Saucer Take 1 Extra Turn 37 Off Course Lose 20 Points 38 Marvelous Navigation Advance 2 Check Points or Score 20 Points 39 Rough Air Slow Down Return 2 Check Points 40 Sky Jack Lose 10 Points Fly to Cuba Roll 9 or Higher to Resume Flight at Point of Sky Jack or Resume After 3 Rolls 41 Excellent Knowledge of Air Traffic Rules. Score 20 Points 42 Roll 8 or Higher Return 2 Check Points 43 Blue Skies Take 1 Extra Turn 44 Complimentary Letter from Airline President Score 30 Points. Additionally, some of the numbered boxes are color coded as well for the reason indicated earlier. The boxes are color coded in random fashion, however, each color is represented four times. Table I refers to the "Airmanship Cards," "Decision Cards" and "Enroute Cards." These are identified by the reference numerals 50, 52, and 54, respectively, and are illustrated only diagrammatically. In this specific embodiment there are about 25 of each but this number may vary. Airmanship Cards 50 are printed on one face with messages such as the following: 1. Because Snoopy is your favorite pilot -- score 10 points! 2. Because you discovered and reported a malfunctioning radio navigation device -- score 15 points! 3. Because you bounced on a recent landing -- lose 20 points! 4. Because stewardess spilled salad on passengers -- lose 10 points! 5. Last month you made a mistake in your Pilot Log Book -- lose 10 points! (Two cards are used.) 6. Because you blamed your last bad landing on your First Officer -- lose 10 points! 7. Because you goofed on a recent flight and announced an incorrect landmark to your passengers -- lose 20 points! 8. Because you had Chicken Pox and couldn't take your last flight physical on time -- lose 5 points! 9. Because you overshot a recent landing and stuck the nosewheel in the mud -- lose 20 points! 10. Because you became "owly" with your First Officer when he suggested that you brush up on Air Traffic Regulations -- lose 10 points! 11. Operations complimented you on the beautiful writing in your Pilot Log Book -- score 10 points! However, because you made a mistake -- lose next turn! 12. Stewardess sits on your lap -- score 10 points! However, because it is against regulations -- lose your next turn! 13. Because you petted a small fuzzy poodle on a passenger's lap -- score 10 points! However, because dogs are not permitted in the passenger section -- lose next turn! 14. Because you divide the flying time with the First Officer -- score 10 points! 15. Because of your ability to produce fuzzy teddy bears for small passengers during bumpy flights -- score 30 points! 16. Superior rating on recent proficiency flight check -- score 30 points! 17. Your passengers think you are the best pilot ever -- score 20 points! 18. You were voted "Pilot of the Month" by the Stewardess' Association -- score 10 points! 19. Congratulations! Promoted to Senior Captain -- score 25 points! 20. Won duck lover's award for delaying a recent take off because of a mother duck and ducklings on runway -- score 20 points! 21. Passenger on a recent flight wrote letter to airline complimenting you -- score 20 points! 22. Passed flight physical with flying colors -- score 10 points! 23. Because of exceptional skill in adjusting engine and flight controls for maximum efficiency -- score 15 points! Decision cards 52 are printed on one face with decisions such as these: 1. Score 10 points or take 1 Airmanship Card! (This card used 2 times.) 2. May score 15 points or take 1 Enroute card. (Used once.) 3. May advance 1 check point or score 5 times the throw of 1 die. (Used 2 times.) 4. Return the throw of 1 die in check points or lose 30 points. (Used once.) 5. Return 1 check point or lose 3 times the throw of 1 die in points. (Used once.) 6. May return 3 check points or lose 10 times the throw of one die in points. (Used 2 times.) 7. Keep to prevent future Sky Jack or score 20 points now! (Used 2 times.) 8. May take 2 Enroute cards or score 20 points. (Used once.) 9. May return 2 check points or lose 3 times the throw of both dice in points! (Used 2 times.) 10. May advance 1 check point or score double the throw of both dice in points. (Used once.) 11. May return 2 check points or lose 20 points! (Used once.) 12. May take 1 Enroute card or 1 Airmanship card. (Used 2 times.) 13. May advance 1 check point or score 15 points. (Used 2 times.) 14. May score 5 times the throw of 1 die in points or take 1 Enroute card! (Used 2 times.) 15. May advance in checkpoints the throw of 1 die or score 10 times the throw of 1 die in points! (Used 2 times.) Enroute cards 54 are printed on one face with various situations encountered by the pilot. 1. Because of your excellent voice communications with ground stations -- score 20 points! 2. Because your cockpit radar indicates a severe storm directly on your course, you wisely detour and explain the situation to your passengers -- score 15 points! 3. Because you arrived over your last checkpoint exactly on time -- score 20 points for excellent navigation! 4. Because of excellent preflight planning, you took advantage of favorable tailwinds at your cruising altitude -- advance 2 checkpoints! 5. Because you pointed out beautiful cloud formations to your passengers -- score 10 points! 6. Because you arrived over your last checkpoint exactly on time -- score 20 points for excellent navigation! 7. Because you flew well around a high flying flock of geese -- score 10 points! 8. Because you keep your passengers advised concerning the progress of the flight -- score 10 points! 9. Because of excellent pre-flight planning, you took advantage of favorable tailwinds at your cruising altitude -- advance 2 checkpoints! 10. Because of exceptional skill in adjusting throttles and trim settings for maximum speed -- advance 2 checkpoints! 11. Because your cockpit radar indicates a severe storm directly on your course, you wisely detour and explain the situation to your passengers -- score 15 points! 12. Favorable tailwinds at your cruising altitude -- advance 2 checkpoints! 13. Alternate Airport! Because the weather at your destination airport is below your landing minimum requirements -- continue to your alternate airport! 14. Sky-Jack! Fly directly to Cuba. On next turn, roll 10 or higher to resume flight at point of Sky-Jack. May resume flight after 3 attempts but lose 20 points! 15. Encounter "Jet Stream" headwinds -- roll (1) die and return the member of checkpoints thrown. 16. A ground station along your route reports that you were 5 miles off-course at your last check point -- lose 30 points! 17. Encounter "Jet Stream" headwinds -- roll 1 die and return the number of checkpoints thrown! 18. Encounter strong headwinds -- return 1 checkpoint! 19. A ground station reports that you were 3 miles off-course at your last checkpoint -- lose 20 points! 20. Sky-Jack! Fly directly to Cuba. On next turn roll 10 or higher to resume flight at point of Sky-Jack. May resume flight after 3 attempts but lose 20 points! 21. Because you got wise with an air traffic controller on the radio -- lose 15 points! 22. You are entering a high density air traffic area and must slow down for safety -- return 1 checkpoint. However, score 20 points for proper procedure. 23. Because you took proper evasive action because of an unidentified flying object -- score 15 points! 24. Because you keep your passengers informed concerning the progress of the flight -- score 10 points! 25. Alternate Airport! Because the weather at your destination airport is below your landing minimum requirements -- continue to your alternate airport! RULES OF THE GAME 1. Two, three or four players may play. 2. Starting with the player at the South (Texas) side of the board, each player in turn (clockwise) rolls the dice 60. The player with the highest dice roll wins his/her choice of flights; second highest roll wins second choice, etc. In case of ties, those who tied roll again until the tie is broken. 3. Each player places his color-coded "board marker," a circular disc 62, on the "TAKE OFF" 22 block on the game board 10. 4. Each player places his color-coded aircraft 64 at the airport where his flight originates, e.g., Flight Red originates at Spokane; Flight Blue at Pittsburgh, etc. 5. Again, each player, in turn (clockwise), starting at the South (Texas) side of the board rolls both dice to determine who starts the game. The player with the highest dice roll starts the game (attempts to take off) and each player follows in clockwise order. 6. Seven or higher is required to take off. If the first player fails to roll 7 or higher, play moves to the next player in clockwise order. If he rolls 7 or higher he moves his aircraft to the first checkpoint (the short line drawn perpendicular to the route) and passes the dice to the next player. 7. After reaching his first checkpoint, each player, in turn, rolls both dice. He then moves his board marker around the board (counterclockwise) the number of blocks thrown on the dice and follows the instructions shown on the block on which his marker lands, i.e., the legend of Table I. 8. Each time a player's board marker travels completely around the game board and passes the "TAKE OFF" block, the player moves his aircraft one checkpoint towards his destination. 9. The moment any player arrives at his/her destination or Alternate Airport and has the most points, that player wins the game! SPECIAL SITUATIONS A. When an aircraft reaches its destination or Alternate Airport, whichever is the case, it cannot be Sky-Jacked, or otherwise be forced to return in checkpoints. In other words, the only way an aircraft that has arrived at its destination can be affected is by points, either plus or minus! B. If an aircraft arrives at its destination or Alternate Airport, but the player does not have the greatest number of points, the player continues to play as before, i.e., he continues to move his board marker based on his dice rolls and scores or loses points accordingly. The instant such a player scores more points than any other player, he wins the game! This is an unusual situation but can occur. C. If a player receives a card requiring him to lose points, he can only lose points if he has points to lose, i.e., negative points are not utilized. D. If a player arrives at his destination and receives a card involving both points and checkpoints, or lands on a block involving both, only the instructions concerning points shall be followed. While this game has been illustrated with a map of the United States, it is to be understood that the world map could be used, or continents, or outer space, etc.

1a

CROSS REFERENCE TO RELATED APPLICATION [0001] This is a divisional of prior U.S. application Ser. No. 12/658,300, filed Feb. 9, 2010, which claims the benefit of U.S. Provisional Application Serial No. 61/210 311, filed Mar. 17, 2009, the disclosures of which are hereby incorporated by reference in their entirety. FIELD OF THE INVENTION [0002] This invention is related generally to an electrosurgical system having a controller for selectively changing the intensity of power applied to an electrosurgical probe in a cutting mode and providing a constant power to the probe in a coagulation mode. The system can include a mechanically powered tool that shares a control console with the electrosurgical probe. BACKGROUND OF THE INVENTION [0003] Endoscopy in the medical field allows internal features of the body of a patient to be viewed without the use of traditional, fully-invasive surgery. Endoscopic imaging systems enable a user to view a surgical site and endoscopic cutting tools enable non-invasive surgery at the site. For instance, an RF generator provides energy to a distal end tip of an RF probe within the surgical site. In one mode, the RF probe provides RF energy at a power level to ablate or otherwise surgically remove tissue. In another instance, RF energy is provided to the RF probe in order to coagulate the tissue at the surgical site to minimize bleeding thereat. [0004] Tissue ablation is achieved when a high power electrical signal having a sufficiently large voltage is generated by a control console and directed to an attached probe. Application of the high power signal to the probe results in a large voltage difference between the two electrodes located at the tip of the probe (presuming a bipolar probe), with the active electrode being generally 200 volts more than the passive or return electrode. This large voltage difference leads to the formation of an ionized region between the two electrodes, establishing a high energy field at the tip of the probe. Applying the tip of the probe to organic tissue leads to a rapid rise in the internal temperature of the cells making up the neighboring tissue. This rapid rise in temperature near instantaneously causes the intracellular water to boil and the cells to burst and vaporize, a process otherwise known as tissue ablation. An electrosurgical “cut” is thus made by the path of disrupted cells that are ablated by the extremely hot, high energy ionized region maintained at the tip of the probe. An added benefit of electrosurgical cuts is that they cause relatively little bleeding, which is the result of dissipation of heat to the tissue at the margins of the cut that produces a zone of coagulation along the cut edge. [0005] In contrast to tissue ablation, the application of a low power electrical signal having a relatively low voltage to the active electrode located at the tip of the probe results in coagulation. Specifically, the lower voltage difference established between the active and return electrodes results in a relatively slow heating of the cells, which in turn causes desiccation or dehydration of the tissue without causing the cells to burst. [0006] FIG. 1 corresponds to FIG. 1 of U.S. Patent Publication No. 2007/0167941, owned by the same assignee hereof, the disclosure of which is hereby incorporated by reference. [0007] As illustrated in FIG. 1 , a typical electrosurgical system 10 includes an electrosurgical probe 12 (hereafter referred to simply as “probe”) and a control console or controller 14 . Interface 15 enables configuration of various devices connected to the console 14 . The probe 12 generally comprises an elongated shaft 16 with a handle or body 18 at one end and a tip 20 at the opposite end. A single active electrode 19 is provided at the tip 20 if the probe 12 is of a “monopolar” design. Conversely, the probe 12 may be provided with both an active electrode 19 and a return electrode 21 at the tip 20 if the probe is “bipolar” in design. The probe 12 connects to control console 14 by means of a detachable cable 22 . The current for energizing the probe 12 comes from control console 14 . When actuated, the control console 14 generates a power signal suitable for applying across the electrode(s) located at the tip 20 of the probe 12 . Specifically, current generated by the control console 14 travels through the cable 22 and down the shaft 16 to tip 20 , where the current subsequently energizes the active electrode 19 . If the probe 12 is monopolar, the current will depart from tip 20 and travel through the patient's body to a remote return electrode, such as a grounding pad. If the probe 12 is bipolar, the current will primarily pass from the active electrode 19 located at tip 20 to the return electrode 21 , also located at tip 20 , and subsequently along a return path back up the shaft 16 and through the detachable cable 22 to the control console 14 . [0008] After configuration of the control console 14 is carried out by means of the interface 15 , actuation and control of the probe 12 by the surgeon is accomplished by one or more switches 23 , typically located on the probe 12 . One or more remote controllers, such as, for example, a footswitch 24 having additional switches 25 - 28 , respectively, may also be utilized to provide the surgeon with greater control over the system 10 . In response to the surgeon's manipulation of the various switches 23 on the probe 12 and/or remote footswitch 24 , the control console 14 generates and applies various low and high power signals to electrode 19 . [0009] Actuation of coagulation switch 26 of footswitch 24 results in coagulation of the tissue adjacent the tip 20 of the probe 12 . While operating in coagulation mode, the control console 14 of the prior art system shown in FIG. 1 is configured to drive the electrosurgical probe at a low, but constant, power level. Due to inherent varying conditions in tissue (i.e., the presence of connective tissue versus fatty tissue, as well as the presence or absence of saline solution), the impedance or load that the system experiences may vary. According to Ohm's law, a change in impedance will result in a change in current levels and/or a change in voltage levels, which in turn, will result in changing power levels. If the operating power level of the system changes by more than a predefined amount, the control console 14 will attempt to compensate and return the power back to its originally designated level by regulating either the voltage and/or current of the power signal being generated by the console and used to drive the attached probe 12 . [0010] Electrosurgical systems 10 also have a cutting mode for cutting tissue. Actuation of cutting switch 25 of the footswitch 24 places the electrosurgical system 10 in the cutting or ablation mode by application of a high energy signal to probe 12 . In the cutting mode, the controller 14 outputs constant energy to the electrosurgical probe 12 while an operator maintains at least a predetermined force to actuate the cutting switch 25 . [0011] In a cutting operation, to change the power level of energy applied to the electrosurgical probe 12 , the cutting switch 25 must be off. Then a user actuates either of switches 27 , 28 on the footswitch 24 , which function as controls for increasing and decreasing the power intensity output level, respectively. The electrosurgical system 10 senses actuation of increase switch 27 for increasing the power intensity value for output by the control console 14 depending on the original intensity value setting and the number of times the switch 27 is pressed. Likewise the electrosurgical system senses actuation of decrease switch 28 for decreasing the power intensity value from a previous value. Then, upon actuation of switch 25 , the RF generator in the console 14 applies power to the probe 12 at the newly selected power level. [0012] While the system shown in FIG. 1 adjusts cutting energy that is output from an RF generator in the control console 14 , the changes in power level are made while the RF generator is off. Thus, a cutting operation must be interrupted or discontinued to change the power level. FIG. 2 shows one example wherein eleven separate discrete power levels are selectable for an electrosurgical system. Turning off energy to the electrode 19 to change power levels increases the length of time required to perform a surgery, which can be detrimental to the patient. [0013] In the electrosurgical system 10 shown in FIG. 1 , a non-volatile memory device (not shown) and reader/writer (not shown) can be incorporated into the handle 18 of the electrosurgical probe 12 , or alternatively, incorporated into or on the cable 22 that is part of the probe 12 and which is used to connect the probe 12 to the control console 14 of the system. Alternatively, the memory device may be configured so as to be incorporated into or on the communication port that is located at the free end of the cable 22 and which is used to interface the cable with a corresponding port on the control console 14 . [0014] During manufacturing of the probe shown in FIG. 1 , data representing probe-specific operating parameters is loaded into the memory device. Upon connection of the probe 12 to the control console 14 of the electrosurgical system 10 , the data stored in the probe's non-volatile memory can be accessed by a reader and forwarded on to the control console 14 . As such, once an electrosurgical probe 12 is connected, the control console 14 accesses the configuration data of the specific probe 12 and automatically configures itself based on the operating parameters of the probe. [0015] Beyond probe-specific operating parameters, the memory device within each attachable probe 12 can store additional data concerning usage of the probe. This usage data includes a variety of information. For example, usage data may represent the number of times an electrosurgical probe 12 has been used, or the duration of the time that the probe has been activated overall or operated at different power levels. Additional usage data may restrict the amount of time that a specific attachable probe can be used. In addition to usage data, the prior art memory device can store information concerning any errors that were encountered during use of the probe 12 . [0016] One embodiment of the invention is directed to a system for an electrosurgical probe that dynamically adjusts power output from the probe without deactivating and then reactivating an RF generator. This arrangement can minimize the length of time for an operating procedure. [0017] One embodiment of the invention disclosed herein is directed to improving cutting of tissue by an electrosurgical probe, such as by manually adjusting or varying the intensity of power delivered to tissue by a generator without temporarily interrupting the application of power. This arrangement also includes an actuator for coagulating tissue at a constant power level. [0018] In another embodiment of the invention, operation of an electrosurgical system is obtained by providing a controller to vary the intensity of power applied to an electrosurgical probe without disruption in a first variable mode, and by providing a second fixed mode wherein energy to the RF probe is discontinued to allow a user to change the power level. BRIEF DESCRIPTION OF THE DRAWINGS [0019] FIG. 1 depicts an electrosurgical system that includes an electrosurgical probe connected to a control console, along with a footswitch. [0020] FIG. 2 is a graph showing output power at a plurality of set points having corresponding different power levels. [0021] FIG. 3 depicts an electrosurgical system of the invention that includes a foot controller, an electrosurgical probe and a powered surgical handpiece for attachment to a control console. [0022] FIG. 4 is a block diagram of the electrosurgical system. [0023] FIG. 5 is a top perspective view of the foot controller shown in FIG. 3 . [0024] FIG. 6 is a flow chart showing steps for controlling power to an electrosurgical probe depending on selected operating modes. [0025] FIG. 7 is a flow chart for a variable mode subroutine that provides varying power levels to an electrosurgical probe without discontinuing power to the probe. [0026] FIG. 8 illustrates a graph showing delivered power versus percentage of pedal press of an actuator. [0027] FIG. 9 is a flow chart for a fixed mode subroutine that requires no application of power to an electrosurgical probe to change a power level value. [0028] FIG. 10 is a tool/probe routine which includes selecting the device to be operated. [0029] FIG. 11 is a flow chart showing a second embodiment for controlling an electrosurgical probe. [0030] FIG. 12 is a flow chart of a cutting subroutine for the embodiment of FIG. 11 . DETAILED DESCRIPTION [0031] FIG. 3 shows a surgical system 30 including a console 32 having a visual display screen 33 , a footswitch receiving port 34 , a handpiece receiving port 36 , an RF probe receiving port 38 and control console selectors. The visual display screen 33 displays devices connected to the receiving ports 36 , 38 . The display screen 33 is capable of displaying a plurality of modes for selection in response to actuation of selected ones of the console selectors. The footswitch receiving port 34 provides a connection to the control console 32 for a foot controller 40 . Handpiece receiving port 36 receives the connection jack of a powered surgical handpiece 42 with a cutting element attached thereto, for instance a mechanical cutting tool or cutting element 43 , such as a burr. The powered surgical handpiece 42 can control oscillation or rotation speed of the mechanical cutting tool 43 secured thereto in response to actuation of the foot controller 40 . RF probe receiving port 38 receives a connecting jack of an RF or electrosurgical probe 44 having an electrode 46 . In some embodiments, control console selectors include push buttons that control or scroll through menus shown on the visual display screen 33 of the control console 32 . In some instances, one or more of the selectors select user preferences for particular operating modes of the surgical handpiece 42 with a mechanical cutting element 43 , such as a burr secured thereto or the electrosurgical probe 44 of the surgical system 30 . [0032] The handpiece 42 of the surgical system 30 includes a transceiver (not shown) and a non-volatile memory device (not shown). The transceiver acts as a reading device for reading cutter-specific data from the cutting element 43 . [0033] One embodiment of the RF probe structure generally corresponds to the probe structure illustrated in FIG. 1 , except additional probe-specific data, described later herein, is provided on a one-wire memory 48 as shown in FIG. 4 for reading by the control console 32 . The control console 32 includes a processing device 50 for processing the data received from the one-wire memory device 48 . The processing device 50 shown in FIG. 4 controls an RF generator 52 that provides RF energy to the electrosurgical probe 44 to power the electrode 46 disposed at the distal end thereof. Controller [0034] The foot controller 40 illustrated in FIGS. 3-5 is similar in structure to the remote console disclosed in U.S. Patent Publication No. 2006/0116667, owned by the same assignee hereof, the disclosure of which is hereby incorporated by reference. [0035] As shown in FIG. 5 , the foot controller 40 includes a device selection actuator 56 , a power decrease actuator 58 and a power increase actuator 60 . The device selection actuator 56 chooses between a powered surgical handpiece 42 and an electrosurgical probe 44 that are connected to the control console 32 for operation thereof. Further, the controller 40 includes a cutting power actuator 62 and a coagulation actuator 64 for operating the electrosurgical probe 44 when the probe is selected. In the fixed cutting mode, the actuator 62 acts as a switch that enables cutting by the electrosurgical probe 44 . In the variable cutting mode, the actuator 62 provides a changing output value depending on the total force applied thereto. Detailed operation of the foot controller 40 for the surgical system 30 is discussed below. Electrosurgical Probe Routine [0036] FIG. 6 is a flow chart representing an electrosurgical probe routine 68 for a processing device 50 operating the RF generator 52 that supplies power to the electrosurgical probe 44 . In one embodiment of the invention, selectors of the control console 32 enable an operator to select between a variable mode and a fixed mode for operation of the electrosurgical probe 44 . [0037] The probe routine 68 illustrated in FIG. 6 begins at start 70 . A user selects the variable mode or the fixed mode. Further, other modes for selection, such as a device configuration mode are contemplated. In another embodiment, a user selects a menu entry that initializes settings of the surgical system 30 using the stored preference information for a particular user. In other embodiments, a selection switch is provided to select the operating mode. [0038] At step 72 , the processing device 50 determines if the variable mode or the fixed mode has been selected. If the variable mode is chosen by a user, the processing device advances to step 74 . Variable Mode Subroutine [0039] When variable mode subroutine 74 is selected, the processing device 50 executes the variable subroutine illustrated in FIG. 7 . From start 76 , the variable mode subroutine 74 advances to coagulation decision step 78 . If the coagulation actuator 64 provides a coagulation signal, the processing device 50 advances to step 80 and outputs a constant predetermined power value from the RF generator 52 . The RF generator 52 provides the constant predetermined coagulation power value to the electrosurgical probe 44 to coagulate tissue. The processing device 50 then returns to decision step 78 and determines if the coagulation actuator 64 continues to be pressed. [0040] In the instance when the coagulation actuator 64 is not depressed, the variable mode subroutine 74 of the processing device 50 advances to step 82 . At step 82 , the processing device 50 determines whether the dual purpose power actuator 62 is depressed, and if depressed, a measured force or control value from the dual purpose power actuator 62 is provided to the processing device 50 . At step 83 , depending on the amount of force applied to the actuator 62 , such as a foot pedal, the processing device 50 controls the RF generator 52 to output a discrete power level from the electrosurgical probe 44 that is proportional with respect to the measured force or sensed control value received from the actuator 62 . So long as the actuator 62 is depressed, at decision step 82 the routine advances to execute at step 83 and then returns to step 82 of the variable mode subroutine 74 and repeats same. When the actuator 62 is not depressed at decision step 82 , the variable mode subroutine 74 advances to return 84 and the variable mode subroutine ends. [0041] The variable mode enables an operator to select from the various power level outputs illustrated in FIG. 8 while being capable of providing different power levels to the electrosurgical probe 44 without first discontinuing power to the probe. The pedal press or force applied to the actuator 62 provides essentially instantaneous variable power control of the power output from the RF generator 52 . As shown in the embodiment of FIG. 8 , the percentage of applied pedal force/pressure or pedal travel extends from 0% to 100% and corresponds to eleven different discrete power levels or values that depend on the force applied to the actuator 62 . In another embodiment, the amount of movement of a pedal of the actuator 62 controls the power level provided by the RF generator 52 . [0042] Returning to FIG. 6 , when the power actuator 62 no longer receives at least a predetermined force, the processing device 50 advances to probe reset decision step 90 . At step 90 , the processing device 50 determines if a selector of the control console 32 has been operated to select the other electrosurgical probe operating mode, a configuration routine or other operating mode for execution by processing device 50 . If one of the electrosurgical probe mode subroutines 74 , 92 is or remains selected, the processing device 50 advances to step 72 . [0043] In one embodiment, the actuator 62 includes a hall effect sensor that determines the movement or position of a pedal of the actuator and controls the power levels as illustrated in FIG. 8 . Further, in some embodiments the actuator 62 is a force transducer or pressure transducer for sensing force applied thereto, without necessarily having significant movement of a foot pedal or other element thereof. In these embodiments the power level output can be linear with respect to the force applied to the pedal of the actuator 62 . In other embodiments the power level output is non-linear with respect to the force applied to the pedal. [0044] In some embodiments the actuator 62 is a position sensor including a series of position responsive switches actuated in response to the amount of movement of a pedal of the actuator to provide a linear increase in the power level with respect to movement of the pedal. In some embodiments the power level output is non-linear with respect to foot travel distance or movement of the actuator 62 . [0045] While FIG. 8 shows eleven discrete power levels for the variable mode of operation, fewer or more power levels can be provided. For example, in some embodiments twenty or more power levels are correlated with the force applied to the actuator 62 and provided to processing device 50 to obtain a more precise output power level control. As discussed above, the variable mode results in less cutting delay and thus a less time consuming surgical procedure. [0046] In some embodiments, a default to the variable mode or to the fixed mode for the electrosurgical probe 44 is provided when the surgical system 30 is initially powered on. Fixed Mode Subroutine [0047] At decision step 72 in probe routine 68 shown in FIG. 6 , if the variable mode is not indicated at decision step 72 , the processing device 50 advances to fixed mode subroutine 92 shown in FIG. 9 . [0048] The fixed mode subroutine 92 shown in FIG. 9 executes by advancing from start 94 to coagulation decision step 96 . In the fixed mode subroutine 92 , if the coagulation actuator 64 is depressed, the processing device 50 advances to step 98 . At step 98 , the processing device 50 operates to provide an essentially constant coagulation power value from the RF generator 52 to the electrosurgical probe 44 . As shown in FIG. 9 , from step 98 , the processing device 50 returns to coagulation decision step 96 . At step 96 , if the coagulation actuator 64 is not actuated, the coagulation power value is no longer output and the processing device 50 advances to step 100 . [0049] At step 100 , the processing device determines if any of actuators 58 , 60 and 62 are depressed. If actuator 62 is depressed, the RF generator 52 provides power to the electrosurgical probe 44 at an initial power value or level provided at system start-up or at a power level previously set by a user operating the control console 32 . If the actuator 62 is depressed to enable power to the electrosurgical probe 44 , actuators 58 , 60 are disabled and do not function. Thus the power level provided by the RF generator 52 to the electrosurgical probe 44 remains essentially constant. [0050] At step 100 , if power increase actuator 60 is depressed with actuator 62 not operative, the discrete power level to be output by the RF generator 52 is increased. In some embodiments, the power level increases in a manner corresponding to the various set points for discrete power level as shown in FIG. 2 , for each actuation of actuator 60 that is sensed by foot controller 40 and provided to the processor device 50 . [0051] If the power decrease actuator 58 is operated at step 100 with actuator 62 not operative, the discrete power level value is decreased for each actuation thereof. The power level decreases in a manner generally corresponding to the various set points for discrete power level as illustrated, for example, in FIG. 2 for each actuation of the actuator 58 . At return step 102 , the fixed mode subroutine 92 returns to the electrosurgical probe routine 68 shown in FIG. 6 . Tool/Probe Routine [0052] FIG. 10 is a flow chart directed to a tool/probe routine 108 for the processing device 50 . The routine 108 begins at start 110 and advances to a tool decision step 112 . When tool operation is selected at decision step 112 , the processing device 50 advances to tool routine 114 . Tool routine 114 is a known method of operating the cutting element 43 mounted to the powered surgical handpiece 42 . U.S. Patent Publication No. 2006/0116667 discloses an arrangement wherein various elements are operated with one controller. Thus, the tool routine 114 will not be discussed in detail herein. [0053] In tool routine 114 , the actuators on the foot controller 40 control the powered surgical handpiece 42 to power a cutting element 43 to cut tissue. After tool routine 114 , operation of the processing device 50 advances to decision step 116 . At step 116 , if a different device or mode is not selected, the processing device 50 returns to tool routine 114 and continues to operate the mechanical cutting tool or cutting element 43 that is mounted to the powered handpiece 42 . [0054] When a device reselection has been determined at step 116 , the processing device 50 returns to tool decision step 112 . At tool decision step 112 , if the tool is not selected, the processing device 50 advances to probe decision step 115 . If an electrosurgical probe operation is selected by the actuator 56 , the processing device 50 advances to electrosurgical probe routine 68 illustrated in FIG. 6 . The probe routine 68 operates as discussed above until electrosurgical probe operation is discontinued as illustrated at step 120 in FIG. 6 and can eventually return to the tool decision step 112 illustrated in FIG. 10 . [0055] In FIG. 10 , if the electrosurgical probe is not selected at decision step 115 , the processing device 50 can advance to select state 124 . [0056] The term “select state” references a state wherein a large number of additional modes can be operated, such as configuration modes or the like. [0057] One mode, as discussed in FIG. 1 , includes reading of one-wire memory devices 48 or reading of RFID chips disposed in the electrosurgical probe 44 or in the powered surgical handpiece 42 . Such data is received by the processing device 50 and stored therein to assist in operation thereof. For instance, data related to the operating parameters of the cutting element 43 mounted to the powered surgical handpiece 42 , or related to the electrosurgical probe 44 having an electrode 46 , may be stored by the processing device 50 to ensure proper operation thereof. [0058] In other embodiments, additional operating modes or subroutines enable control of both the cutting element 43 and electrode 46 simultaneously with actuators on at least one of the handpiece 42 , the electrosurgical probe 44 and the control console 32 , along with the controller 40 . Alternative Electrosurgical Probe Routine [0059] FIG. 11 is a flow chart representing a second embodiment of an electrosurgical probe routine. The electrosurgical probe routine 200 shown in FIG. 11 is executed by processing device 50 to control the RF generator 52 that supplies power to the electrosurgical probe 44 . The electrosurgical probe routine 200 begins at start 202 . In one embodiment, at start 202 the processing device 50 already has stored therein available default preferences for a particular user with regard to pre-selection of the variable or fixed operating mode and properties of the particular electrosurgical probe 44 connected to the console. [0060] From start 202 , the routine 200 advances to coagulation decision step 204 . The processor 50 determines if the coagulation actuator 64 is enabled. If so, the processor 50 advances to step 206 . At step 206 , the processor 50 controls the RF generator 52 to supply coagulation power to the electrosurgical probe 44 so long as the actuator 64 is enabled. When the actuator 64 is disengaged, the processor 50 advances to return step 208 and returns to start 202 . [0061] Returning to coagulation decision step 204 , when the processor 50 determines that the coagulation actuator 64 is not enabled, the probe routine 200 advances to increase power level decision step 210 . At decision step 210 , the processor 50 determines if the power increase actuator 60 is enabled. When the power increase actuator 60 is enabled, the routine 200 advances to step 212 . At step 212 , the stored power level value for the cutting operation is increased or incremented by a discrete power level value. [0062] In some embodiments, if the discrete power level is at a maximum value and thus cannot be further increased, enabling of the power increase actuator 60 selects the fixed cutting mode for operation instead of the variable cutting mode or maintains the fixed cutting mode. In other embodiments, the processor 50 changes the electrosurgical probe arrangement from the fixed cutting mode to the variable cutting mode, or remains in the variable cutting mode, when the power increase actuator 60 is enabled while at the maximum power level value. [0063] After the power increase actuator 60 is disengaged, the processor 50 advances to return step 214 and returns to start 202 . [0064] Returning to decision step 210 shown in FIG. 11 , when the processor 50 determines that the power increase actuator 60 is not enabled, the routine 200 advances to decrease power level decision step 216 . At decision step 216 , the processor 50 determines if the power decrease actuator 56 is enabled. When the power decrease actuator 56 is enabled, the probe routine 200 advances to step 218 . At step 218 , the power level value for the cutting operation is decreased by a discrete power level value. When the decrease actuator 56 is disabled, the routine 200 advances to return step 220 and then returns to start step 202 . [0065] Returning to decision step 216 , when the power decrease actuator 56 is not enabled, the electrosurgical probe routine 200 advances to cutting subroutine 230 shown in FIG. 12 . The cutting subroutine 230 begins at block 232 shown in FIG. 12 which represents a NO output from decision step 216 of the electrosurgical probe routine 200 shown in FIG. 11 . [0066] In the cutting subroutine 230 , the processor 50 advances from block 232 to cutting decision step 234 . At decision step 234 , the processor 50 determines if the cutting actuator 62 is enabled. When the cutting actuator 62 is not enabled, the processor 50 advances to return step 236 and returns to start step 202 illustrated in FIG. 11 . [0067] When the cutting actuator 62 is actuated, the processor 50 advances from cutting decision step 234 , to variable mode decision step 238 . At decision step 238 , the processor 50 determines if the electrosurgical probe arrangement is set in the variable operating mode. [0068] In some embodiments, variable mode is preset for the console as a user preference at start up of the control console 32 . As discussed above, in some embodiments the power increase actuator 60 selects the variable mode. In other embodiments, a separate actuator (not shown) selects between the variable and fixed operating mode for the electrosurgical probe 44 . [0069] At the variable mode decision step 238 , when the processor 50 determines that the variable mode has been set or selected, the cutting subroutine 230 advances to variable cut step 240 to provide a variable power output from the RF generator 52 to the electrosurgical probe 44 so long as the cutting actuator 62 is operated. [0070] As discussed in the first embodiment shown in FIGS. 6 , 7 and 9 , the cutting power actuator 62 can vary the power from a low value to a maximum value based upon measurement of the force applied thereto. In another embodiment, movement of the actuator 62 against a biasing device, such as a spring element, controls the amount of power supplied from the RF generator 52 to the electrosurgical probe 44 . In some embodiments, the power decrease actuator 58 and the power increase actuator 60 can select a maximum power value for use during variable operation of the electrosurgical probe 44 . [0071] When the cutting power actuator 62 is disabled, power output by the RE generator 52 is discontinued and the processor 50 advances to return step 242 . At step 242 , the cutting subroutine 230 returns to start block 202 of the probe routine 200 illustrated in FIG. 11 . [0072] Returning to decision step 238 , when the processor 50 determines the electrosurgical arrangement is not in the variable mode, the processor 50 advances to constant power level cutting step 244 . At cutting step 244 , the RF generator 52 provides the pre-selected constant power level to the electrosurgical probe 44 until the cutting power actuator 62 is deactivated. After deactivation, the RF generator 52 stops providing power and the processor 50 advances to return step 246 . At step 246 , the cutting subroutine 230 returns to start step 202 of the probe routine 200 illustrated in FIG. 11 . Alternatives [0073] While the above embodiments disclose a specific control pattern or function for each of the actuators 56 , 58 , 60 , 62 , 64 on the controller 40 , which in this embodiment is a foot controller, other embodiments of actuators provided on a controller 40 are contemplated. In some embodiments, the actuators are repositioned or the functions of specific individual actuators on a foot controller can be changed. [0074] As set forth above, the actuator 62 enables power to the electrosurgical probe 44 in both a variable mode and a fixed mode. Thus, the actuator 62 may be considered a variable/fixed mode power actuator. In some embodiments, other actuators provide the same, different, or multiple functions. [0075] While FIGS. 4 and 5 only show a foot operated controller 40 , other embodiments are contemplated. For instance, the electrosurgical probe 44 illustrated in FIG. 3 may have a grouping of three or more actuators disposed thereon that perform essentially the same functions as the actuators on the foot controller 40 . Further, in another embodiment, the actuators illustrated in FIG. 5 are provided as control buttons on the control console 32 as illustrated in FIG. 3 . [0076] In some embodiments, various actuators disposed on the controller 40 or disposed on the electrosurgical probe 44 may perform similar functions or share control of the electrosurgical probe. In one embodiment, an operator utilizes the foot controller 40 to select a variable power cutting mode or a fixed power cutting mode. Then, one of the actuators on the electrosurgical probe 44 shown in FIG. 3 is operated to provide various discrete power levels to the electrode 46 in a similar manner as the actuators disposed on the foot controller 40 . [0077] In some embodiments the control console 32 provides an audible and/or visual indication of the selected device and the selected mode. [0078] While FIGS. 2 and 8 disclose power values at various settings, in some embodiments a power value corresponds to an output voltage value that essentially remains constant regardless of the output resistance or load of the electrosurgical probe 44 and the electrode 46 . Thus, throughout the instant specification and claims, terms such as discrete power level, power value, fixed power, variable power and the like are intended to include predetermined voltage values or voltage levels output by the RF generator 52 . [0079] The routines and subroutines illustrated in FIGS. 6 , 7 and 9 - 12 are for purposes of describing various embodiments of the invention. Additional embodiments of the invention are contemplated wherein the routines and subroutines operate in a different order and/or have additional steps that provide similar operating results as the specific routines and subroutines disclosed herein. [0080] Although particular preferred embodiments of the invention are disclosed in detail for illustrative purposes, it will be recognized that variations or modifications of the disclosed apparatus, including the rearrangements of parts, lie within the scope of the present invention.

1a

RELATED APPLICATIONS This application is a Divisional of U.S. application Ser. No. 09/103,072, filed Jun. 23, 1998, now U.S. Pat. No. 6,813,520, which claims the benefit of U.S. Provisional Application No. 60/084,791, filed May. 8, 1998, and which is a Continuation in Part of U.S. application Ser. No. 08/632,516, filed April 12, 1996, now U.S. Pat. No. 5,769,880, issued Jun. 23, 1998, Reexamination Certificate issued Aug. 24, 2004. FIELD OF THE INVENTION The present invention relates generally to the field of apparatuses and methods for ablating or coagulating the interior surfaces of body organs. Specifically, it relates to an apparatus and method for ablating the interior linings of body organs such as the uterus and gallbladder. BACKGROUND OF THE INVENTION Ablation of the interior lining of a body organ is a procedure which involves heating the organ lining to temperatures which destroy the cells of the lining or coagulate tissue proteins for hemostasis. Such a procedure may be performed as a treatment to one of many conditions, such as chronic bleeding of the endometrial layer of the uterus or abnormalities of the mucosal layer of the gallbladder. Existing methods for effecting ablation include circulation of heated fluid inside the organ (either directly or inside a balloon), laser treatment of the organ lining, and resistive heating using application of RF energy to the tissue to be ablated. U.S. Pat. No. 5,084,044 describes an apparatus for endometrial ablation in which a bladder is inserted into the uterus. Heated fluid is then circulated through the balloon to expand the balloon into contact with the endometrium and to ablate the endometrium thermally. U.S. Pat. No. 5,443,470 describes an apparatus for endometrial ablation in which an expandable bladder is provided with electrodes on its outer surface. After the apparatus is positioned inside the uterus, a non-conductive gas or liquid is used to fill the balloon, causing the balloon to push the electrodes into contact with the endometrial surface. RF energy is supplied to the electrodes to ablate the endometrial tissue using resistive heating. These ablation devices are satisfactory for carrying out ablation procedures. However, because no data or feedback is available to guide the physician as to how deep the tissue ablation has progressed, controlling the ablation depth and ablation profile with such devices can only be done by assumption. For example, the heated fluid method is a very passive and ineffective heating process which relies on the heat conductivity of the tissue. This process does not account for variations in factors such as the amount of contact between the balloon and the underlying tissue, or cooling effects such as those of blood circulating through the organ. RF ablation techniques can achieve more effective ablation since it relies on active heating of the tissue using RF energy, but presently the depth of ablation using RF techniques can only be estimated by the physician since no feedback can be provided as to actual ablation depth. Both the heated fluid techniques and the latest RF techniques must be performed using great care to prevent over ablation. Monitoring of tissue surface temperature is normally carried out during these ablation procedures to ensure the temperature does not exceed 100° C. If the temperature exceeds 100° C., the fluid within the tissue begins to boil and to thereby produce steam. Because ablation is carried out within a closed cavity within the body, the steam cannot escape and may instead force itself deeply into the tissue, or it may pass into areas adjacent to the area intended to be ablated, causing embolism or unintended burning. Moreover, in prior art RF devices the water drawn from the tissue creates a path of conductivity through which current traveling through the electrodes will flow. This can prevent the current from traveling into the tissue to be ablated. Moreover, the presence of this current path around the electrodes causes current to be continuously drawn from the electrodes. The current heats the liquid drawn from the tissue and thus turns the ablation process into a passive heating method in which the heated liquid around the electrodes causes thermal ablation to continue well beyond the desired ablation depths. Another problem with prior art ablation devices is that it is difficult for a physician to find out when ablation has been carried out to a desired depth within the tissue. Thus, it is often the case that too much or too little tissue may be ablated during an ablation procedure. It is therefore desirable to provide an ablation device which eliminates the above-described problem of steam and liquid buildup at the ablation site. It is further desirable to provide an ablation method and device which allows the depth of ablation to be controlled and which automatically discontinues ablation once the desired ablation depth has been reached. SUMMARY OF THE INVENTION The present invention is an apparatus and method of ablating and/or coagulating tissue, such as that of the uterus or other organ. An ablation device is provided which has an electrode array carried by an elongate tubular member. The electrode array includes a fluid permeable elastic member preferably formed of a metallized fabric having insulating regions and conductive regions thereon. During use, the electrode array is positioned in contact with tissue to be ablated, ablation energy is delivered through the array to the tissue to cause the tissue to dehydrate, and moisture generated during dehydration is actively or passively drawn into the array and away from the tissue. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a front elevation view of a first embodiment of an ablation device according to the present invention, with the handle shown in cross-section and with the RF applicator head in a closed condition. FIG. 2 is a front elevation view of the ablation device of FIG. 1 , with the handle shown in cross-section and with the RF applicator head in an open condition. FIG. 3 is a side elevation view of the ablation device of FIG. 2 . FIG. 4 is a top plan view of the ablation device of FIG. 2 . FIG. 5A is a front elevation view of the applicator head and a portion of the main body of the ablation device of FIG. 2 , with the main body shown in cross-section. FIG. 5B is a cross-section view of the main body taken along the plane designated 5 B- 5 B in FIG. 5A . FIG. 6 is a schematic representation of a uterus showing the ablation device of FIG. 1 following insertion of the device into the uterus but prior to retraction of the introducer sheath and activation of the spring members. FIG. 7 is a schematic representation of a uterus showing the ablation device of FIG. 1 following insertion of the device into the uterus and following the retraction of the introducer sheath and the expansion of the RF applicator head. FIG. 8 is a cross-section view of the RF applicator head and the distal portion of the main body of the apparatus of FIG. 1 , showing the RF applicator head in the closed condition. FIG. 9 is a cross-section view of the RF applicator head and the distal portion of the main body of the apparatus of FIG. 1 , showing the configuration of RF applicator head after the sheath has been retracted but before the spring members have been released by proximal movement of the shaft. FIG. 10 is a cross-section view of the RF applicator head and the distal portion of the main body of the apparatus of FIG. 1 , showing the configuration of RF applicator head after the sheath has been retracted and after the spring members have been released into the fully opened condition. FIG. 11 is a cross-section view of a distal portion of an RF ablation device similar to FIG. 1 which utilizes an alternative spring member configuration for the RF applicator head. FIG. 12 is a side elevation view of the distal end of an alternate embodiment of an RF ablation device similar to that of FIG. 1 , which utilizes an RF applicator head having a modified shape. FIG. 13 is a top plan view of the ablation device of FIG. 12 . FIG. 14 is a representation of a bleeding vessel illustrating use of the ablation device of FIG. 12 for general bleeding control. FIGS. 15 and 16 are representations of a uterus illustrating use of the ablation device of FIG. 12 for endometrial ablation. FIG. 17 is a representation of a prostate gland illustrating use of the ablation device of FIG. 12 for prostate ablation. FIG. 18 is a cross-section view of target tissue for ablation, showing ablation electrodes in contact with the tissue surface and illustrating energy fields generated during bi-polar ablation. FIGS. 19A-19C are cross-section views of target tissue for ablation, showing electrodes in contact with the tissue surface and illustrating how varying active electrode density may be used to vary the ablation depth. FIG. 20 is a side elevation view, similar to the view of FIG. 2 , showing an ablation device according to the present invention in which the electrode carrying means includes inflatable balloons. For purposes of clarity, the electrodes on the electrode carrying means are not shown. FIG. 21 is a side elevation view of a second exemplary embodiment of an ablation device according to the present invention, showing the array in the retracted state. FIG. 22 is a side elevation view of the ablation device of FIG. 21 , showing the array in the deployed state. FIG. 23 is a top plan view of the applicator head of the apparatus of FIG. 21 . FIG. 24 is a cross-sectional top view of the encircled region designated 24 in FIG. 23 . FIG. 25A is a perspective view of the electrode array of FIG. 23 . FIG. 25B is a distal end view of the applicator head of FIG. 30A . FIG. 26A is a plan view of a knit that may be used to form the applicator head. FIG. 26B is a perspective view of a strand of nylon-wrapped spandex of the type that may be used to form the knit of FIG. 26A . FIGS. 27A , 27 B, 27 C are top plan views illustrating triangular, parabolic, and rectangular mesh shapes for use as electrode arrays according to the present invention. FIG. 28 is a perspective view showing the flexures and hypotube of the deflecting mechanism of the applicator head of FIG. 23 . FIG. 29 is a cross-section view of a flexure taken along the plane designated 29 - 29 in FIG. 23 . FIG. 30 is a top plan view illustrating the flexure and spring arrangement of an alternative configuration of a deflecting mechanism for an applicator head according to the present invention. FIG. 31 is a cross-sectional side view of the bobbin portion of the apparatus of FIG. 21 . FIG. 32A is a side elevation view of the handle of the ablation device of FIG. 21 . FIG. 32B is a top plan view of the handle of the ablation device of FIG. 21 . For clarity, portions of the proximal and distal grips are not shown. FIG. 33 illustrates placement of the applicator head according to the present invention in a uterine cavity. FIG. 34 is a side elevation view of the handle of the ablation apparatus of FIG. 21 , showing portions of the apparatus in cross-section. FIG. 35 is a front elevation view of the upper portion of the proximal handle grip taken along the plane designated 35 - 35 in FIG. 32B . FIGS. 36A , 36 B, and 36 C are a series of side elevation views illustrating the heel member as it becomes engaged with the corresponding spring member. FIGS. 37A and 37B are cross-sectional top views of the frame member mounted on the proximal grip section, taken along the plane designated 37 - 37 in FIG. 34 and illustrating one of the load limiting features of the second embodiment. FIG. 37A shows the condition of the compression spring before the heel member moves into abutment with frame member, and FIG. 37B shows the condition of the spring after the heel member moves into abutment with the frame member. DETAILED DESCRIPTION The invention described in this application is an aspect of a larger set of inventions described in the following co-pending applications which are commonly owned by the assignee of the present invention, and are hereby incorporated by reference: U.S. Provisional Patent Application No. 60/084,724, filed May. 8, 1998, entitled “APPARATUS AND METHOD FOR INTRA-ORGAN MEASUREMENT AND ABLATION”; and U.S. Provisional Patent Application No. 60/084,712 filed May. 8, 1998, entitled “A RADIO-FREQUENCY GENERATOR FOR POWERING AN ABLATION DEVICE”. The ablation apparatus according to the present invention will be described with respect to two exemplary embodiments. First Exemplary Embodiment—Structure Referring to FIGS. 1 and 2 , an ablation device according to the present invention is comprised generally of three major components: RF applicator head 2 , main body 4 , and handle 6 . Main body 4 includes a shaft 10 . The RF applicator head 2 includes an electrode carrying means 12 mounted to the distal end of the shaft 10 and an array of electrodes 14 formed on the surface of the electrode carrying means 12 . An RF generator 16 is electrically connected to the electrodes 14 to provide mono-polar or bipolar RF energy to them. Shaft 10 is an elongate member having a hollow interior. Shaft 10 is preferably 12 inches long and has a preferred cross-sectional diameter of approximately 4 mm. A collar 13 is formed on the exterior of the shaft 10 at the proximal end. As best shown in FIGS. 6 and 7 , passive spring member 15 are attached to the distal end of the shaft 10 . Extending through the shaft 10 is a suction/insufflation tube 17 ( FIGS. 6-9 ) having a plurality of holes 17 a formed in its distal end. An arched active spring member 19 is connected between the distal ends of the passive spring members 15 and the distal end of the suction/insufflation tube 17 . Referring to FIG. 2 , electrode leads 18 a and 18 b extend through the shaft 10 from distal end 20 to proximal end 22 of the shaft 10 . At the distal end 20 of the shaft 10 , each of the leads 18 a , 18 b is coupled to a respective one of the electrodes 14 . At the proximal end 22 of the shaft 10 , the leads 18 a , 18 b are electrically connected to RF generator 16 via an electrical connector 21 . During use, the leads 18 a , 18 b carry RF energy from the RF generator 16 to the electrodes. Each of the leads 18 a , 18 b is insulated and carries energy of an opposite polarity than the other lead. Electrically insulated sensor leads 23 a , 23 b ( FIGS. 5A and 5B ) also extend through the shaft 10 . Contact sensors 25 a , 25 b are attached to the distal ends of the sensor leads 23 a , 23 b , respectively and are mounted to the electrode carrying means 12 . During use, the sensor leads 23 a , 23 b are coupled by the connector 21 to a monitoring module in the RF generator 16 which measures impedance between the sensors 25 a , 25 b . Alternatively, a reference pad may be positioned in contact with the patient and the impedance between one of the sensors and the reference pad measured. Referring to FIG. 5B , electrode leads 18 a , 18 b and sensor leads 23 a , 23 b extend through the shaft 10 between the external walls of the tube 17 and the interior walls of the shaft 10 and they are coupled to electrical connector 21 which is preferably mounted to the collar 13 on the shaft 10 . Connector 21 , which is connectable to the RF generator 16 , includes at least four electrical contact rings 21 a - 21 d ( FIGS. 1 and 2 ) which correspond to each of the leads 18 a , 18 b , 23 a , 23 b . Rings 21 a , 21 b receive, from the RF generator, RF energy of positive and negative polarity, respectively. Rings 21 c , 21 d deliver signals from the right and left sensors, respectively, to a monitoring module within the RF generator 16 . Referring to FIG. 5A , the electrode carrying means 12 is attached to the distal end 20 of the shaft 10 . A plurality of holes 24 may be formed in the portion of the distal end 20 of the shaft which lies within the electrode carrying means 12 . The electrode carrying means 12 preferably has a shape which approximates the shape of the body organ which is to be ablated. For example, the apparatus shown in FIGS. 1 through 11 has a bicornual shape which is desirable for intrauterine ablation. The electrode carrying means 12 shown in these figures includes horn regions 26 which during use are positioned within the cornual regions of the uterus and which therefore extend towards the fallopian tubes. Electrode carrying means 12 is preferably a sack formed of a material which is non-conductive, which is permeable to moisture and/or which has a tendency to absorb moisture, and which may be compressed to a smaller volume and subsequently released to its natural size upon elimination of compression. Examples of preferred materials for the electrode carrying means include open cell sponge, foam, cotton, fabric, or cotton-like material, or any other material having the desired characteristics. Alternatively, the electrode carrying means may be formed of a metallized fabric. For convenience, the term “pad” may be used interchangeably with the term electrode carrying means to refer to an electrode carrying means formed of any of the above materials or having the listed properties. Electrodes 14 are preferably attached to the outer surface of the electrode carrying means 12 , such as by deposition or other attachment mechanism. The electrodes are preferably made of lengths of silver, gold, platinum, or any other conductive material. The electrodes may be attached to the electrode carrying means 12 by electron beam deposition, or they may be formed into coiled wires and bonded to the electrode carrying member using a flexible adhesive. Naturally, other means of attaching the electrodes, such as sewing them onto the surface of the carrying member, may alternatively be used. If the electrode carrying means 12 is formed of a metallized fabric, an insulating layer may be etched onto the fabric surface, leaving only the electrode regions exposed. The spacing between the electrodes (i.e. the distance between the centers of adjacent electrodes) and the widths of the electrodes are selected so that ablation will reach predetermined depths within the tissue, particularly when maximum power is delivered through the electrodes (where maximum power is the level at which low impedance, low voltage ablation can be achieved). The depth of ablation is also effected by the electrode density (i.e., the percentage of the target tissue area which is in contact with active electrode surfaces) and may be regulated by pre-selecting the amount of this active electrode coverage. For example, the depth of ablation is much greater when the active electrode surface covers more than 10% of the target tissue than it is when the active electrode surfaces covers 1% of the target tissue. For example, by using 3-6 mm spacing and an electrode width of approximately 0.5-2.5 mm, delivery of approximately 20-40 watts over a 9-16 cm 2 target tissue area will cause ablation to a depth of approximately 5-7 millimeters when the active electrode surface covers more than 10% of the target tissue area. After reaching this ablation depth, the impedance of the tissue will become so great that ablation will self-terminate as described with respect to the operation of the invention. By contrast, using the same power, spacing, electrode width, and RF frequency will produce an ablation depth of only 2-3 mm when the active electrode surfaces covers less than 1% of the target tissue area. This can be better understood with reference to FIG. 19A , in which high surface density electrodes are designated 14 a and low surface density electrodes are designated 14 b . For purposes of this comparison between low and high surface density electrodes, each bracketed group of low density electrodes is considered to be a single electrode. Thus, the electrode widths W and spacings S extend as shown in FIG. 19A . As is apparent from FIG. 19A , the electrodes 14 a , which have more active area in contact with the underlying tissue T, produce a region of ablation A 1 that extends more deeply into the tissue T than the ablation region A 2 produced by the low density electrodes 14 b , even though the electrode spacings and widths are the same for the high and low density electrodes. Some examples of electrode widths, having spacings with more than 10% active electrode surface coverage, and their resultant ablation depth, based on an ablation area of 6 cm 2 and a power of 20-40 watts, are given on the following table: ELECTRODE WIDTH SPACING APPROX. DEPTH 1 mm 1-2 mm 1-3 mm 1-2.5 mm 3-6 mm 5-7 mm 1-4.5 mm 8-10 mm 8-10 mm Examples of electrode widths, having spacings with less than 1% active electrode surface coverage, and their resultant ablation depth, based on an ablation area of 6 cm 2 and a power of 20-40 watts, are given on the following table: ELECTRODE WIDTH SPACING APPROX. DEPTH 1 mm 1-2 mm 0.5-1 mm 1-2.5 mm 3-6 mm 2-3 mm 1-4.5 mm 8-10 mm 2-3 mm Thus it can be seen that the depth of ablation is significantly less when the active electrode surface coverage is decreased. In the preferred embodiment, the preferred electrode spacing is approximately 8-10 mm in the horn regions 26 with the active electrode surfaces covering approximately 1% of the target region. Approximately 1-2 mm electrode spacing (with 10% active electrode coverage) is preferred in the cervical region (designated 28 ) and approximately 3-6 mm (with greater than 10% active electrode surface coverage) is preferred in the main body region. The RF generator 16 may be configured to include a controller which gives the user a choice of which electrodes should be energized during a particular application in order to give the user control of ablation depth. For example, during an application for which deep ablation is desired, the user may elect to have the generator energize every other electrode, to thereby optimize the effective spacing of the electrodes and to decrease the percentage of active electrode surface coverage, as will be described below with respect to FIG. 18 . Although the electrodes shown in the drawings are arranged in a particular pattern, it should be appreciated that the electrodes may be arranged in any pattern to provide ablation to desired depths. Referring to FIGS. 6 and 7 , an introducer sheath 32 facilitates insertion of the apparatus into, and removal of the apparatus from, the body organ to be ablated. The sheath 32 is a tubular member which is telescopically slidable over the shaft 10 . The sheath 32 is slidable between a distal condition, shown in FIG. 6 , in which the electrode carrying means 12 is compressed inside the sheath, and a proximal condition in which the sheath 32 is moved proximally to release the electrode carrying means from inside it ( FIG. 7 ). By compressing the electrode carrying means 12 to a small volume, the electrode carrying means and electrodes can be easily inserted into the body cavity (such as into the uterus via the vaginal opening). A handle 34 attached to the sheath 32 provides finger holds to allow for manipulation of the sheath 32 . Handle 34 is slidably mounted on a handle rail 35 which includes a sleeve 33 , a finger cutout 37 , and a pair of spaced rails 35 a , 35 b extending between the sleeve 33 and the finger cutout 37 . The shaft 10 and sheath 32 slidably extend through the sleeve 33 and between the rails 35 a , 35 b . The tube 17 also extends through the sleeve 33 and between the rails 35 a , 35 b , and its proximal end is fixed to the handle rail 35 near the finger cutout 37 . A compression spring 39 is disposed around the proximal most portion of the suction/insufflation tube 17 which lies between the rails 35 a , 35 b . One end of the compression spring 39 rests against the collar 13 on the shaft 10 , while the opposite end of the compression spring rests against the handle rail 35 . During use, the sheath 32 is retracted from the electrode carrying means 12 by squeezing the handle 34 towards the finger cutout 37 to slide the sheath 32 in the distal direction. When the handle 34 advances against the collar 13 , the shaft 10 (which is attached to the collar 13 ) is forced to slide in the proximal direction, causing compression of the spring 39 against the handle rail 35 . The movement of the shaft 10 relative to the suction/insufflation tube 17 causes the shaft 10 to pull proximally on the passive spring member 15 . Proximal movement of the passive spring member 15 in turn pulls against the active spring member 19 , causing it to move to the opened condition shown in FIG. 7 . Unless the shaft is held in this retracted condition, the compression spring 39 will push the collar and thus the shaft distally, forcing the RF applicator head to close. A locking mechanism (not shown) may be provided to hold the shaft in the fully withdrawn condition to prevent inadvertent closure of the spring members during the ablation procedure. The amount by which the springs 15 , 19 are spread may be controlled by manipulating the handle 34 to slide the shaft 10 (via collar 13 ), proximally or distally. Such sliding movement of the shaft 10 causes forceps-like movement of the spring members 15 , 19 . A flow pathway 36 is formed in the handle rail 35 and is fluidly coupled to a suction/insufflation port 38 . The proximal end of the suction/insufflation tube 17 is fluidly coupled to the flow pathway so that gas fluid may be introduced into, or withdrawn from the suction/insufflation tube 17 via the suction/insufflation port 38 . For example, suction may be applied to the fluid port 38 using a suction/insufflation unit 40 . This causes water vapor within the uterine cavity to pass through the permeable electrode carrying means 12 , into the suction/insufflation tube 17 via holes 17 a , through the tube 17 , and through the suction/insufflation unit 40 via the port 38 . If insufflation of the uterine cavity is desired, insufflation gas, such as carbon dioxide, may be introduced into the suction/insufflation tube 17 via the port 38 . The insufflation gas travels through the tube 17 , through the holes 17 a , and into the uterine cavity through the permeable electrode carrying member 12 . If desirable, additional components may be provided for endoscopic visualization purposes. For example, lumen 42 , 44 , and 46 may be formed in the walls of the introducer sheath 32 as shown in FIG. 5B . An imaging conduit, such as a fiberoptic cable 48 , extends through lumen 42 and is coupled via a camera cable 43 to a camera 45 . Images taken from the camera may be displayed on a monitor 56 . An illumination fiber 50 extends through lumen 44 and is coupled to an illumination source 54 . The third lumen 46 is an instrument channel through which surgical instruments may be introduced into the uterine cavity, if necessary. Because during use it is most desirable for the electrodes 14 on the surface of the electrode carrying means 12 to be held in contact with the interior surface of the organ to be ablated, the electrode carrying means 12 may be provide to have additional components inside it that add structural integrity to the electrode carrying means when it is deployed within the body. For example, referring to FIG. 11 , alternative spring members 15 a , 19 a may be attached to the shaft 10 and biased such that, when in a resting state, the spring members are positioned in the fully resting condition shown in FIG. 11 . Such spring members would spring to the resting condition upon withdrawal of the sheath 32 from the RF applicator head 2 . Alternatively, a pair of inflatable balloons 52 may be arranged inside the electrode carrying means 12 as shown in FIG. 20 and connected to a tube (not shown) extending through the shaft 10 and into the balloons 52 . After insertion of the apparatus into the organ and following retraction of the sheath 32 , the balloons 52 would be inflated by introduction of an inflation medium such as air into the balloons via a port similar to port 38 using an apparatus similar to the suction/insufflation apparatus 40 . Structural integrity may also be added to the electrode carrying means through the application of suction to the proximal end 22 of the suction/insufflation tube 17 . Application of suction using the suction/insufflation device 40 would draw the organ tissue towards the electrode carrying means 12 and thus into better contact with the electrodes 14 . FIGS. 12 and 13 show an alternative embodiment of an ablation device according to the present invention. In the alternative embodiment, an electrode carrying means 12 a is provided which has a shape which is generally tubular and thus is not specific to any particular organ shape. An ablation device having a general shape such as this may be used anywhere within the body where ablation or coagulation is needed. For example, the alternative embodiment is useful for bleeding control during laparoscopic surgery ( FIG. 14 ), tissue ablation in the prostate gland ( FIG. 17 ), and also intrauterine ablation ( FIGS. 15 and 16 ). First Exemplary Embodiment—Operation Operation of the first exemplary embodiment of an ablation device according to the present invention will next be described. Referring to FIG. 1 , the device is initially configured for use by positioning the introducer sheath 32 distally along the shaft 10 , such that it compresses the electrode carrying means 12 within its walls. At this time, the electrical connector 21 is connected to the RF generator 16 , and the fiberoptic cable 48 and the illumination cable 50 are connected to the illumination source, monitor, and camera, 54 , 56 , 45 . The suction/insufflation unit 40 is attached to suction/insufflation port 38 on the handle rail 35 . The suction/insufflation unit 40 is preferably set to deliver carbon dioxide at an insufflation pressure of 20-200 mmHg. Next, the distal end of the apparatus is inserted through the vaginal opening V and into the uterus U as shown in FIG. 6 , until the distal end of the introducer sheath 32 contacts the fundus F of the uterus. At this point, carbon dioxide gas is introduced into the tube 17 via the port 38 , and it enters the uterine cavity, thereby expanding the uterine cavity from a flat triangular shape to a 1-2 cm high triangular cavity. The physician may observe (using the camera 45 and monitor 56 ) the internal cavities using images detected by a fiberoptic cable 48 inserted through lumen 42 . If, upon observation, the physician determines that a tissue biopsy or other procedure is needed, the required instruments may be inserted into the uterine cavity via the instrument channel 46 . Following insertion, the handle 34 is withdrawn until it abuts the collar 13 . At this point, the sheath 32 exposes the electrode carrying member 12 but the electrode carrying member 12 is not yet fully expanded (see FIG. 9 ), because the spring members 15 , 19 have not yet been moved to their open condition. The handle 34 is withdrawn further, causing the shaft 10 to move proximally relative to the suction/insufflation tube 17 , causing the passive spring members 15 to pull the active spring members 19 , causing them to open into the opened condition showing in FIG. 10 . The physician may confirm proper positioning of the electrode carrying member 12 using the monitor 56 , which displays images from the fiberoptic cable 48 . Proper positioning of the device and sufficient contact between the electrode carrying member 12 and the endometrium may further be confirmed using the contact sensors 25 a , 25 b . The monitoring module of the RF generator measures the impedance between these sensors using conventional means. If there is good contact between the sensors and the endometrium, the measured impedance will be approximately 20-180 ohm, depending on the water content of the endometrial lining. The sensors are positioned on the distal portions of the bicornual shaped electrode carrying member 12 , which during use are positioned in the regions within the uterus in which it is most difficult to achieve good contact with the endometrium. Thus, an indication from the sensors 25 a , 25 b that there is sound contact between the sensors and the endometrial surface indicates that good electrode contact has been made with the endometrium. Next, insufflation is terminated. Approximately 1-5 cc of saline may be introduced via suction/insufflation tube 17 to initially wet the electrodes and to improve electrode electrical contact with the tissue. After introduction of saline, the suction/insufflation device 40 is switched to a suctioning mode. As described above, the application of suction to the RF applicator head 2 via the suction/insufflation tube 17 collapses the uterine cavity onto the RF applicator head 2 and thus assures better contact between the electrodes and the endometrial tissue. If the generally tubular apparatus of FIGS. 12 and 13 is used, the device is angled into contact with one side of the uterus during the ablation procedure. Once ablation is completed, the device (or a new device) is repositioned in contact with the opposite side and the procedure is repeated. See. FIGS. 15 and 16 . Next, RF energy at preferably about 500 kHz and at a constant power of approximately 30 W is applied to the electrodes. As shown in FIG. 5 a , it is preferable that each electrode be energized at a polarity opposite from that of its neighboring electrodes. By doing so, energy field patterns, designated F 1 , F 2 and F 4 in FIG. 18 , are generated between the electrode sites and thus help to direct the flow of current through the tissue T to form a region of ablation A. As can be seen in FIG. 18 , if electrode spacing is increased such by energizing, for example every third or fifth electrode rather than all electrodes, the energy patterns will extend more deeply into the tissue. (See, for example, pattern F 2 which results from energization of electrodes having a non-energized electrode between them, or pattern F 4 which results from energization of electrodes having two non-energized electrodes between them). Moreover, ablation depth may be controlled as described above by providing low surface density electrodes on areas of the electrode carrying member which will contact tissue areas at which a smaller ablation depth is required (see FIG. 19A ). Referring to FIG. 19B , if multiple, closely spaced, electrodes 14 are provided on the electrode carrying member, a user may set the RF generator to energize electrodes which will produce a desired electrode spacing and active electrode area. For example, alternate electrodes may be energized as shown in FIG. 19B , with the first three energized electrodes having positive polarity, the second three having negative polarity, etc. As another example, shown in FIG. 19C , if greater ablation depth is desired the first five electrodes may be positively energized, and the seventh through eleventh electrodes negatively energized, with the sixth electrode remaining inactivated to provide adequate electrode spacing. As the endometrial tissue heats, moisture begins to be released from the tissue. The moisture permeates the electrode carrying member 12 and is thereby drawn away from the electrodes. The moisture may pass through the holes 17 a in the suction/insufflation tube 17 and leave the suction/insufflation tube 17 at its proximal end via port 38 as shown in FIG. 7 . Moisture removal from the ablation site may be further facilitated by the application of suction to the shaft 10 using the suction/insufflation unit 40 . Removal of the moisture from the ablation site prevents formation of a liquid layer around the electrodes. As described above, liquid build-up at the ablation site is detrimental in that provides a conductive layer that carries current from the electrodes even when ablation has reached the desired depth. This continued current flow heats the liquid and surrounding tissue, and thus causes ablation to continue by unpredictable thermal conduction means. Tissue which has been ablated becomes dehydrated and thus decreases in conductivity. By shunting moisture away from the ablation site and thus preventing liquid build-up, there is no liquid conductor at the ablation area during use of the ablation device of the present invention. Thus, when ablation has reached the desired depth, the impedance at the tissue surface becomes sufficiently high to stop or nearly stop the flow of current into the tissue. RF ablation thereby stops and thermal ablation does not occur in significant amounts. If the RF generator is equipped with an impedance monitor, a physician utilizing the ablation device can monitor the impedance at the electrodes and will know that ablation has self-terminated once the impedance rises to a certain level and then remains fairly constant. By contrast, if a prior art bipolar RF ablation device was used together with an impedance monitor, the presence of liquid around the electrodes would cause the impedance monitor to give a low impedance reading regardless of the depth of ablation which had already been carried out, since current would continue to travel through the low-impedance liquid layer. Other means for monitoring and terminating ablation may also be provided. For example, a thermocouple or other temperature sensor may be inserted to a predetermined depth in the tissue to monitor the temperature of the tissue and terminate the delivery of RF energy or otherwise signal the user when the tissue has reached a desired ablation temperature. Once the process has self terminated, 1-5 cc of saline can be introduced via suction/insufflation tube 17 and allowed to sit for a short time to aid separation of the electrode from the tissue surface. The suction insufflation device 40 is then switched to provide insufflation of carbon dioxide at a pressure of 20-200 mmHg. The insufflation pressure helps to lift the ablated tissue away from the RF applicator head 2 and to thus ease the closing of the RF applicator head. The RF applicator head 2 is moved to the closed position by sliding the handle 34 in a distal direction to fold the spring members 15 , 19 along the axis of the device and to cause the introducer sheath 32 to slide over the folded RF applicator head. The physician may visually confirm the sufficiency of the ablation using the monitor 56 . Finally, the apparatus is removed from the uterine cavity. Second Exemplary Embodiment—Structure A second embodiment of an ablation device 100 in accordance with the present invention is shown in FIGS. 21-37B . The second embodiment differs from the first embodiment primarily in its electrode pattern and in the mechanism used to deploy the electrode applicator head or array. Naturally, aspects of the first and second exemplary embodiments and their methods of operation may be combined without departing from the scope of the present invention. Referring to FIGS. 21 and 22 , the second embodiment includes an RF applicator head 102 , a sheath 104 , and a handle 106 . As with the first embodiment, the applicator head 102 is slidably disposed within the sheath 104 ( FIG. 21 ) during insertion of the device into the uterine cavity, and the handle 106 is subsequently manipulated to cause the applicator head 102 to extend from the distal end of the sheath 104 ( FIG. 22 ) and to expand into contact with body tissue ( FIG. 33 ). RF Applicator Head Referring to FIG. 23 , in which the sheath 104 is not shown for clarity, applicator head 102 extends from the distal end of a length of tubing 108 which is slidably disposed within the sheath 104 . Applicator head 102 includes an external electrode array 102 a and an internal deflecting mechanism 102 b used to expand and tension the array for positioning into contact with the tissue. Referring to FIGS. 25A and 25B , the array 102 a of applicator head 102 is formed of a stretchable metallized fabric mesh which is preferably knitted from a nylon and spandex knit plated with gold or other conductive material. In one array design, the knit (shown in FIGS. 26A and 26B ) is formed of three monofilaments of nylon 109 a knitted together with single yarns of spandex 109 b . Each yarn of spandex 109 b has a double helix 109 c of five nylon monofilaments coiled around it. This knit of elastic (spandex) and inelastic (nylon) yarns is beneficial for a number of reasons. For example, knitting elastic and relatively inelastic yarns allows the overall deformability of the array to be pre-selected. The mesh is preferably constructed so as to have greater elasticity in the transverse direction (T) than in the longitudinal direction (L). In a preferred mesh design, the transverse elasticity is on the order of approximately 300% whereas the longitudinal elasticity is on the order of approximately 100%. The large transverse elasticity of the array allows it to be used in a wide range of uterine sizes. Another advantage provided by the combination of elastic and relatively inelastic yarns is that the elastic yarns provide the needed elasticity to the array while the relatively inelastic yarns provide relatively non-stretchable members to which the metallization can adhere without cracking during expansion of the array. In the knit configuration described above, the metallization adheres to the nylon coiled around the spandex. During expansion of the array, the spandex elongates and the nylon double helix at least partially elongates from its coiled configuration. One process which may be used to apply the gold to the nylon/spandex knit involves plating the knit with silver using known processes which involve application of other materials as base layers prior to application of the silver to ensure that the silver will adhere. Next, the insulating regions 110 (described below) are etched onto the silver, and afterwards the gold is plated onto the silver. Gold is desirable for the array because of it has a relatively smooth surface, is a very inert material, and has sufficient ductility that it will not crack as the nylon coil elongates during use. The mesh may be configured in a variety of shapes, including but not limited to the triangular shape S 1 , parabolic S 2 , and rectangular S 3 shapes shown in FIGS. 27A , 27 B and 27 C, respectively. Turning again to FIGS. 25A and 25B , when in its expanded state, the array 102 a includes a pair of broad faces 112 spaced apart from one another. Narrower side faces 114 extend between the broad faces 112 along the sides of the applicator head 102 , and a distal face 116 extends between the broad faces 112 at the distal end of the applicator head 102 . Insulating regions 110 are formed on the applicator head to divide the mesh into electrode regions. The insulated regions 110 are preferably formed using etching techniques to remove the conductive metal from the mesh, although alternate methods may also be used, such as by knitting conductive and non-conductive materials together to form the array. The array may be divided by the insulated regions 110 into a variety of electrode configurations. In a preferred configuration the insulating regions 110 divide the applicator head into four electrodes 118 a - 118 d by creating two electrodes on each of the broad faces 112 . To create this four-electrode pattern, insulating regions 110 are placed longitudinally along each of the broad faces 112 as well as along the length of each of the faces 114 , 16 . The electrodes 118 a - 118 d are used for ablation and, if desired, to measure tissue impedance during use. Deflecting mechanism 102 b and its deployment structure is enclosed within electrode array 102 a . Referring to FIG. 23 , external hypotube 120 extends from tubing 108 and an internal hypotube 122 is slidably and co-axially disposed within hypotube 120 . Flexures 124 extend from the tubing 108 on opposite sides of external hypotube 120 . A plurality of longitudinally spaced apertures 126 ( FIG. 28 ) are formed in each flexure 124 . During use, apertures 126 allow moisture to pass through the flexures and to be drawn into exposed distal end of hypotube 120 using a vacuum source fluidly coupled to hypotube 120 . Each flexure 124 preferably includes conductive regions that are electrically coupled to the array 102 a for delivery of RF energy to the body tissue. Referring to FIG. 29 , strips 128 of copper tape or other conductive material extend along opposite surfaces of each flexure 124 . Each strip 128 is electrically insulated from the other strip 128 by a non-conductive coating on the flexure. Conductor leads (not shown) are electrically coupled to the strips 128 and extend through tubing 108 ( FIG. 23 ) to an electrical cord 130 ( FIG. 21 ) which is attachable to the RF generator. During use, one strip 128 on each conductor is electrically coupled via the conductor leads to one terminal on the RF generator while the other strip is electrically coupled to the opposite terminal, thus causing the array on the applicator head to have regions of alternating positive and negative polarity. The flexures may alternatively be formed using a conductive material or a conductively coated material having insulating regions formed thereon to divide the flexure surfaces into multiple conductive regions. Moreover, alternative methods such as electrode leads independent of the flexures 124 may instead be used for electrically connecting the electrode array to the source of RF energy. It is important to ensure proper alignment between the conductive regions of the flexures 124 (e.g. copper strips 128 ) and the electrodes 118 a - 118 d in order to maintain electrical contact between the two. Strands of thread 134 (which may be nylon) ( FIG. 23 ) are preferably sewn through the array 102 a and around the flexures 124 in order to prevent the conductive regions 128 from slipping out of alignment with the electrodes 118 a - 118 d . Alternate methods for maintaining contact between the array 102 a and the conductive regions 128 include using tiny bendable barbs extending between the flexures 124 and the array 102 a to hook the array to the conductive regions 128 , or bonding the array to the flexures using an adhesive applied along the insulating regions of the flexures. Referring again to FIG. 23 , internal flexures 136 extend laterally and longitudinally from the exterior surface of hypotube 122 . Each internal flexure 136 is connected at its distal end to one of the flexures 124 and a transverse ribbon 138 extends between the distal portions of the internal flexures 136 . Transverse ribbon 138 is preferably pre-shaped such that when in the relaxed condition the ribbon assumes the corrugated configuration shown in FIG. 23 and such that when in a compressed condition it is folded along the plurality of creases 140 that extend along its length. Flexures 124 , 136 and ribbon 138 are preferably an insulated spring material such as heat treated 17-7 PH stainless steel. The deflecting mechanism is preferably configured such that the distal tips of the flexures 124 are sufficiently flexible to prevent tissue puncture during deployment and/or use. Such an atraumatic tip design may be carried out in a number of ways, such as by manufacturing the distal sections 124 a ( FIG. 28 ) of the flexures from a material that is more flexible than the proximal sections 124 b . For example, flexures 124 may be provided to have proximal sections formed of a material having a modulus of approximately 28×10 6 psi and distal sections having a durometer of approximately 72D. Alternatively, referring to FIG. 30 , the flexures 124 may be joined to the internal flexures 136 at a location more proximal than the distal tips of the flexures 124 , allowing them to move more freely and to adapt to the contour of the surface against which they are positioned (see dashed lines in FIG. 30 ). Given that uterine sizes and shapes vary widely between women, the atraumatic tip design is further beneficial in that it allows the device to more accurately conform to the shape of the uterus in which it is deployed while minimizing the chance of injury. The deflecting mechanism formed by the flexures 124 , 136 , and ribbon 138 forms the array into the substantially triangular shape shown in FIG. 23 , which is particularly adaptable to most uterine shapes. As set forth in detail below, during use distal and proximal grips 142 , 144 forming handle 106 are squeezed towards one another to withdraw the sheath and deploy the applicator head. This action results in relative rearward motion of the hypotube 120 and relative forward motion of the hypotube 122 . The relative motion between the hypotubes causes deflection in flexures 124 , 136 which deploys and tensions the electrode array 102 a. Measurement Device The ablation device according to the second embodiment includes a measurement device for easily measuring the uterine width and for displaying the measured width on a gauge 146 ( FIG. 21 ). The measurement device utilizes non-conductive (e.g. nylon) suturing threads 148 that extend from the hypotube 122 and that have distal ends attached to the distal portion of the deflecting mechanism ( FIG. 23 ). As shown in FIG. 24 , threads 148 are preferably formed of a single strand 150 threaded through a wire loop 152 and folded over on itself. Wire loop 152 forms the distal end of an elongate wire 154 which may be formed of stainless steel or other wire. Referring to FIG. 31 , wire 154 extends through the hypotube 122 and is secured to a rotatable bobbin 156 . The rotatable bobbin 156 includes a dial face 158 preferably covered in a clear plastic. As can be seen in FIG. 32 , dial face 158 includes calibration markings corresponding to an appropriate range of uterine widths. The bobbin is disposed within a gauge housing 160 and a corresponding marker line 162 is printed on the gauge housing. A torsion spring 164 provides rotational resistance to the bobbin 156 . Expansion of the applicator head 102 during use pulls threads 148 ( FIG. 23 ) and thus wire 154 ( FIG. 24 ) in a distal direction. Wire 154 pulls against the bobbin 156 ( FIG. 31 ), causing it to rotate. Rotation of the bobbin positions one of the calibration markings on dial face 158 into alignment with the marker line 162 ( FIG. 32B ) to indicate the distance between the distal tips of flexures 124 and thus the uterine width. The uterine width and length (as determined using a conventional sound or other means) are preferably input into an RF generator system and used by the system to calculate an appropriate ablation power as will be described below. Alternately, the width as measured by the apparatus of the invention and length as measured by other means may be used by the user to calculate the power to be supplied to the array to achieve the desired ablation depth. The uterine width may alternatively be measured using other means, including by using a strain gauge in combination with an A/D converter to transduce the separation distance of the flexures 124 and to electronically transmit the uterine width to the RF generator. Control of Ablation Depth The most optimal electrocoagulation occurs when relatively deep ablation is carried out in the regions of the uterus at which the endometrium is thickest, and when relatively shallower ablation is carried out in areas in which the endometrium is shallower. A desirable range of ablation depths includes approximately 2-3 mm for the cervical os and the cornual regions, and approximately 7-8 mm in the main body of the uterus where the endometrium is substantially thicker. As discussed with respect to the first embodiment, a number of factors influence the ablation depth that can be achieved using a given power applied to a bipolar electrode array. These include the power supplied by the RF generator, the distance between the centers of adjacent electrodes (“center-to-center distance”), the electrode density (i.e., the porosity of the array fabric or the percent of the array surface that is metallic), the edge gap (i.e. the distance between the edges of adjacent electrode poles), and the electrode surface area. Other factors include blood flow (which in slower-ablating systems can dissipate the RF) and the impedance limit. Certain of these factors may be utilized in the present invention to control ablation depth and to provide deeper ablation at areas requiring deeper ablation and to provide shallower regions in areas where deep ablation is not needed. For example, as center-to-center distance increases, the depth of ablation increases until a point where the center to center distance is so great that the strength of the RF field is too diffuse to excite the tissue. It can been seen with reference to FIG. 33 that the center to center distance d1 between the electrodes 118 a , 118 b is larger within the region of the array that lies in the main body of the uterus and thus contributes to deeper ablation. The center to center distance d2 between electrodes 118 a , 118 b is smaller towards the cervical canal where it contributes to shallower ablation. At the distal end of the device, the shorter center to center distances d3 extend between top and bottom electrodes 118 b , 118 c and 118 a , 118 d and again contribute to shallower ablation. Naturally, because the array 102 a expands to accommodate the size of the uterus in which it is deployed, the dimensions of the array 102 a vary. One embodiment of the array 102 a includes a range of widths of at least approximately 2.5-4.5 cm, a range of lengths of at least approximately 4-6 cm, and a density of approximately 35%-45%. The power supplied to the array by the RF generator is calculated by the RF generator system to accommodate the electrode area required for a particular patient. As discussed above, the uterine width is measured by the applicator head 102 and displayed on gauge 146 . The uterine length is measured using a sound, which is an instrument conventionally used for that purpose. It should be noted that calibration markings of the type used on a conventional sound device, or other structure for length measurement, may be included on the present invention to allow it to be used for length measurement as well. The user enters the measured dimensions into the RF generator system using an input device, and the RF generator system calculates or obtains the appropriate set power from a stored look-up table using the uterine width and length as entered by the user. An EPROM within the RF generator system converts the length and width to a set power level according to the following relationship: P=L×W× 5.5 Where P is the power level in watts, L is the length in centimeters, W is the width in centimeters, and 5.5 is a constant having units of watts per square centimeter. Alternatively, the user may manually calculate the power setting from the length and width, or s/he may be provided with a table of suggested power settings for various electrode areas (as determined by the measured length and width) and will manually set the power on the RF generator accordingly. Handle Referring again to FIGS. 21 and 22 , the handle 106 of the RF ablation device according to the second embodiment includes a distal grip section 142 and a proximal grip section 144 that are pivotally attached to one another at pivot pin 166 . The proximal grip section 144 is coupled to the hypotube 122 ( FIG. 23 ) via yoke 168 , overload spring 170 and spring stop 172 , each of which is shown in the section view of FIG. 34 . The distal grip section 142 is coupled to the external hypotube 120 via male and female couplers 174 , 176 (see FIGS. 32A and 32B ). Squeezing the grip sections 142 , 144 towards one another thus causes relative movement between the external hypotube 120 and the internal hypotube 122 . This relative sliding movement results in deployment of the deflecting mechanism 102 b from the distal end of the sheath and expansion of the array 102 a to its expanded state. Referring to FIGS. 32A and B, rack 180 is formed on male coupler 174 and calibration markings 182 are printed adjacent the rack 180 . The calibration markings 182 correspond to a variety of uterine lengths and may include lengths ranging from, for example, 4.0 to 6.0 cm in 0.5 cm increments. A sliding collar 184 is slidably disposed on the tubing 108 and is slidable over male coupler 174 . Sliding collar 184 includes a rotating collar 186 and a female coupler 176 that includes a wedge-shaped heel 188 . A locking spring member 190 ( FIGS. 32B and 35 ) extends across an aperture 192 formed in the proximal grip 144 in alignment with the heel 188 . When the distal and proximal handle sections are squeezed together to deploy the array, the heel 188 passes into the aperture 192 . Its inclined lower surface gradually depresses the spring member 190 as the heel moves further into the aperture 192 . See FIGS. 36A and 36B . After passing completely over the spring member, the heel moves out of contact with the spring member. The spring member snaps upwardly thereby engaging the heel in the locked position. See FIG. 36C . A release lever 194 ( FIG. 35 ) is attached to the free end of the spring member 190 . To disengage the spring lock, release lever 194 is depressed to lower spring member 190 so that the inclined heel can pass over the spring member and thus out of the aperture 192 . Referring again to FIGS. 32A and 32B , sliding collar 184 is configured to allow the user to limit longitudinal extension of the array 102 a to a distance commensurate with a patient's predetermined uterine length. It does so by allowing the user to adjust the relative longitudinal position of male coupler 174 relative to the female coupler 176 using the rotating collar 186 to lock and unlock the female coupler from the rack 180 and the male coupler 174 . Locking the female coupler to the rack 180 and male coupler 174 will limit extension of the array to approximately the predetermined uterine length, as shown on the calibration markings 182 . Once the uterine length has been measured using a conventional sound, the user positions sliding collar 184 adjacent to calibration marks 182 corresponding to the measured uterine length (e.g. 4.5 cm). Afterwards, the user rotates the collar section 186 to engage its internally positioned teeth with the rack 180 . This locks the longitudinal position of the heel 188 such that it will engage with the spring member 190 on the proximal grip when the array has been exposed to the length set by the sliding collar. The handle 106 includes a pair of spring assemblies which facilitate controlled deployment and stowage of the array 102 a . One of the spring assemblies controls movement of the grips 142 , 144 to automatically stow the array 102 a into the sheath 104 when the user stops squeezing the grips 142 , 144 towards one another. The other of the spring assemblies controls the transverse movement of the spring flexures 124 to the expanded condition by limiting the maximum load that can be applied to the deployment mechanism 102 b. FIG. 34 shows the distal and proximal grips 142 and 144 in partial cross-section. The first spring assembly for controlled stowage includes a handle return mandrel 196 that is slidably disposed within the proximal grip 144 . A compression spring 198 surrounds a portion of the return mandrel 196 , and a retaining ring 200 is attached to the mandrel 196 above the spring 198 . A spring stop 202 is disposed between the spring 198 and the retaining ring. The lowermost end of the return mandrel 196 is pivotally engaged by a coupling member 204 on distal grip 142 . Relative movement of the grips 142 , 144 towards one another causes the coupling member 204 to pull the return member downwardly with the proximal grip 144 as indicated by arrows. Downward movement of the mandrel 196 causes its retaining ring 200 and spring stop 202 to bear downwardly against the compression spring 198 , thereby providing a movement which acts to rotate the grips 142 , 144 away from one another. When tension against the grips 142 , 144 is released (assuming that heel 188 is not locked into engagement with spring member 190 ) the grips rotate apart into the opened position as the compression spring 198 returns to the initial state, stowing the applicator head inside the sheath. The second spring assembly for controlling array deployment is designed to control separation of the flexures. It includes a frame member 178 disposed over yoke 168 , which is pivotally attached to proximal grip 144 . Tubing 108 extends from the array 102 a (see FIG. 23 ), through the sheath 104 and is fixed at its proximal end to the frame member 178 . Hypotube 122 does not terminate at this point but instead extends beyond the proximal end of tubing 108 and through a window 206 in the frame member. Its proximal end 208 is slidably located within frame member 178 proximally of the window 206 and is fluidly coupled to a vacuum port 210 by fluid channel 212 . Hypotube 120 terminates within the frame. Its proximal end is fixed within the distal end of the frame. A spring stop 214 is fixed to a section of the hypotube within the window 206 , and a compression spring 170 is disposed around the hypotube between the spring stop 172 and yoke 168 . See FIGS. 32B and 34 . When the distal and proximal grips are moved towards one another, the relative rearward motion of the distal grip causes the distal grip to withdraw the sheath 104 from the array 102 a . Referring to FIGS. 37A and 37B , this motion continues until female coupler 176 contacts and bears against frame member 178 . Continued motion between the grips causes a relative rearward motion in the frame which causes the same rearward relative motion in external hypotube 120 . An opposing force is developed in yoke 168 , which causes a relative forward motion in hypotube 122 . The relative motion between the hypotubes causes deflection in flexures 124 , 136 which deflect in a manner that deploys and tensions the electrode array. Compression spring 170 acts to limit the force developed by the operator against hypotubes 120 , 122 , thus limiting the force of flexures 124 , 136 acting on the array and the target tissue surrounding the array. Referring to FIG. 21 , collar 214 is slidably mounted on sheath 104 . Before the device is inserted into the uterus, collar 214 can be positioned along sheath 104 to the position measured by the uterine sound. Once in position, the collar provides visual and tactile feedback to the user to assure the device has been inserted the proper distance. In addition, after the applicator head 102 has been deployed, if the patient's cervical canal diameter is larger than the sheath dimensions, the collar 214 can be moved distally towards the cervix, making contact with it and creating a pneumatic seal between the sheath and cervix. Second Exemplary Embodiment—Operation In preparation for ablating the uterus utilizing the second exemplary embodiment, the user measures the uterine length using a uterine sound device. The user next positions sliding collar 184 ( FIG. 32B ) adjacent to calibration marks 182 corresponding to the measured uterine length (e.g. 4.5 cm) and rotates the collar section 186 to engage its internally positioned teeth with the rack 180 . This locks the longitudinal position of the heel 188 ( FIG. 32A ) such that it will engage with the spring member 190 when the array has been exposed to the length set by the sliding collar. Next, with the grips 142 , 144 in their resting positions to keep the applicator head 102 covered by sheath 104 , the distal end of the device 100 is inserted into the uterus. Once the distal end of the sheath 104 is within the uterus, grips 142 , 144 are squeezed together to deploy the applicator head 102 from sheath 104 . Grips 142 , 144 are squeezed until heel 188 engages with locking spring member 190 as described with respect to FIGS. 36A through 36C . At this point, deflecting mechanism 102 b has deployed the array 102 a into contact with the uterine walls. The user reads the uterine width, which as described above is transduced from the separation of the spring flexures, from gauge 146 . The measured length and width are entered into the RF generator system 250 ( FIG. 21 ) and used to calculate the ablation power. Vacuum source 252 ( FIG. 21 ) is activated, causing application of suction to hypotube 122 via suction port 210 . Suction helps to draw uterine tissue into contact with the array 102 . Ablation power is supplied to the electrode array 102 a by the RF generator system 250 . The tissue is heated as the RF energy passes from electrodes 118 a - d to the tissue, causing moisture to be released from the tissue. The vacuum source helps to draw moisture from the uterine cavity into the hypotube 122 . Moisture withdrawal is facilitated by the apertures 121 formed in flexures 124 by preventing moisture from being trapped between the flexures 124 and the lateral walls of the uterus. If the RF generator 250 includes an impedance monitoring module, impedance may be monitored at the electrodes 118 a - d and the generator may be programmed to terminate RF delivery automatically once the impedance rises to a certain level. The generator system may also or alternatively display the measured impedance and allow the user to terminate RF delivery when desired. When RF delivery is terminated, the user depresses release lever 194 to disengage heel 188 from locking spring member 190 and to thereby allow grips 142 , 144 to move to their expanded (resting condition). Release of grips 142 , 144 causes applicator head 102 to retract to its unexpanded condition and further causes applicator head 102 to be withdrawn into the sheath 104 . Finally, the distal end of the device 100 is withdrawn from the uterus. Two embodiments of ablation devices in accordance with the present invention have been described herein. These embodiments have been shown for illustrative purposes only. It should be understood, however, that the invention is not intended to be limited to the specifics of the illustrated embodiments but is defined only in terms of the following claims.

1a

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] The present invention is broadly concerned with improved daily ration feed products for animals subject to heartworm infection including minor amounts of a heartworm preventative drug. More particularly, the invention is concerned with such feed products, and methods of preparing and using the products, wherein the feeds contain a sufficient quantity of a heartworm preventative drug so that when the animals consume the feeds, therapeutically effective amounts of the drug are established and maintained in the bloodstreams of the animals. In this way, conventional dosing regimes are eliminated, and the animals receive proper quantities of drug as a part of their normal daily diets. [0003] 2. Description of the Prior Art [0004] Heartworm infection is an endemic condition with certain animals, and especially household pets such as cats and dogs. A number of drugs have been developed for the treatment of heartworm infection, such as the avermectins, which are a class of macrocyclic lactones. Drugs of this class include ivermectin, celamectin, moxidectin, milbemycin oxine and eprinomectin. [0005] Ivermectin is a known oral and injectable medication used as a wormer, heartworm preventative and to kill certain mites (mange). Ivermectin is a mixture of (10E,14E,16E,22Z)-(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)-6′-[(S)-sec-butyl]-21,24-dihydroxy-5′,11,13,22-tetramethyl-2-oxo-(3,7,19-trioxatetracyclo[15.6.1.1 4,8 .0 20,24 ]pentacosa-10,14,16,22-tetraene)-6-spiro-2′-(perhydropyran)-12-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-αa-L-arabino-hexopyranosyl)-3-O-methyl-αa-L-arabino-hexopyranoside and (10E,14E,16E,22Z)-(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)-21,24-dihydroxy-6′-isopropyl-5′,11,13,22-tetramethyl-2-oxo-(3,7,19-trioxatetracyclo[15.6.1.1 4,8 .0 20,24 ]pentacosa-10,14,16,22-tetraene)-6-spiro-2′-(perhydropyran)-12-yl2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-αa-L-arabino-hexopyranosyl)-3-O-methyl-αa-L-arabino-hexopyranoside CAS: 70288-86-7. [0006] Selamectin is identified as (5Z,25S)-25-cyclohexyl-4′-O-de(2,6-dideoxy-3-O-methyl-αa-L-arabino-hexopyranosyl)-5-demethoxy-25-de(1-methylpropyl)-22,23-dihydro-5-(hydroxyimino)avermectin A 1a . [0007] Moxidectin is SPIRO[11,15-METHANO-2H,13H,17H-FURO[4,3,2-PQ][2,6]-B ENZODIOXACYCLO-OCTADECIN-13,2′[2H]PYRAN-17-ONE]-6′-[1,3-DIMETHYL-1-BUTENYL]-3′,4′,5′,6,6′,7,10,11,14,15,17a,20,20a,20b-DIHYDRO-4′-[METHOXYIMINO]-5′,6,6,19-TETRAMETHYL-[6R-2aE,4E,4′E,5′S*,6R*,6′S*(E),8E,11R* 13R*,15S*,17aR*, 20R*,20aR*,20bS*]]. [0008] Milbemycin Oxime consists of the oxime derivatives of 5-didehydromilbemycins in the ratio of approximately 80% A4 (C32H45N07, MW 555.71) and 20% A3 (C31H43N07). [0009] Eprinomectin is 4″-epiacetylamino-4″-deoxyavermectin B 1 [0010] These drugs are conventionally provided in tablet form or for larger animals as pastes and injectable liquids. Generally, animals are treated with relatively large doses of these drugs on a periodic basis. In the case of dogs and cats, tablets/chewables are given once a month by mouth year round for heartworm prevention. Higher doses are used to eliminate other parasites. [0011] Ivermectin is the most commonly used heartworm preventative drug in domestic pets, and is generally considered safe at recommended dosage levels. If these are exceeded, side effects such as tremors, staggering, dilated pupils, loss of body weight or death may occur. As a consequence of normal dosing regimes for ivermectin, the treated animals necessarily receive a relatively large quantity of the drug which is to remain effective for an extended period. This in turn means that shortly after treatment the animal has a very high concentration of ivermectin in its bloodstream, with this concentration tailing off during the remainder of the period. This is to be contrasted with a more preferable treatment protocol wherein a substantially constant level of ivermectin is maintained on a continuing basis. [0012] By the same token, the other established heartworm preventative drugs are generally administered in the same fashion as ivermectin, i.e., a relatively large quantity of the drugs are given at intervals, rather than daily administration of the drug to achieve a maintenance level in the animal's bloodstream. [0013] U.S. Pat. No. 6,190,591 describes a single-extruder process for the production of controlled release particles which may be tableted. Various encapsulants including pharmaceuticals, nutraceuticals, nutritional compounds, biologically active components, flavorants, fragrances, detergents and surface-active compositions are described, at relatively large quantities in the particles of at least 1% and preferably from about 3-50%. Hence, the '591 patent is not concerned with complete feeds, but rather encapsulant particles. The process described in this patent make use of an elongated extruder where water and lipid are successively injected into the barrel, followed by water evaporation from the barrel and final addition of encapsulants. Such equipment is generally not suited to the production of a daily ration feed or similar product, given the need to uniformly distribute an active in the latter type of product. [0014] There is accordingly a need in the art for improved feeds and methods of providing heartworm preventative drugs to animals in a manner which will avoid periodic, relatively large ivermectin doses and maintain a substantially constant level of ivermectin in the bloodstreams of the treated animals. SUMMARY OF THE INVENTION [0015] The present invention overcomes the problems outlined above and provides improved heartworm preventative drug-containing daily ration feed products for animals subject to heartworm infection such as cats and dogs, and methods of preparing and using such feeds. Generally speaking, a wide variety of feed types can be improved in accordance with the invention, e.g., extrusion-processed feeds of either dry or semi-moist kind, canned/retorted feeds or fresh refrigerated feeds. When the feeds are produced by extrusion they contain respective quantities of protein, fat and starch, together with a relatively minor amount of a desired heartworm preventative drug. Similarly, with canned or similar products a desired heartworm preventative drug is mixed with the solid and/or liquid fractions thereof to the desired therapeutic level. In all cases, however, it is preferred that the potency of the drug content of the feeds be maintained for at least six months at ambient temperature storage, and more preferably nine months at ambient temperature storage. [0016] Through use of the feed products of the invention, an animal consuming the feeds on a daily basis receives a maintenance quantity of the drug, so that the therapeutic effects thereof are realized. Normally, the drug should be present in the extruded feeds at a level of at least about 2 μg/kg of feed product, more preferably from about 2-1500 μg/kg of feed product, and most preferably from about 5-1000 μg/kg of feed product, although specific drug amounts may vary depending upon the particular drug chosen. In other products within the ambit of the invention, the drug(s) may be present at a level of up to about 0.75% by weight, more preferably up to about 0.5% by weight, and still more preferably up to about 0.1% by weight, based upon the total weight of the drug(s) taken as 100%. [0017] As noted, a wide variety of extruded feeds can be used in the context of the invention. For example, typical dry extruded product having a moisture content of less than about 10% by weight can be produced with added heartworm preventative drug. Similarly, semi-moist feeds having a moisture content on the order of 15-30% by weight are also suitable. In extruded feeds of these types, it is preferred that the drug content be substantially uniformly dispersed throughout the feed. Alternately, pillow-type feeds can be produced having a soft, flowable matrix center surrounded by a shell of self-sustaining feed material; in such a case, the drug content may be present only in the soft center matrix. In most cases, the extruded feed products of the invention should contain from about 5-15% by weight moisture (wet basis), 15-30% by weight protein, more preferably from about 18-25% by weight protein; from about 3-24% by weight fat, more preferably from about 5-20% by weight fat; and from about 5-80% by weight starch, more preferably from about 20-50% by weight starch. Generally, the extruded feeds should have a bulk density of from about 30-700 g/l, more preferably from about 140-400 g/l, and a water activity of from about 0.1-0.99, more preferably from about 0.6-0.75. [0018] An important goal of the invention is to provide heartworm preventative drug-containing daily ration feeds which when consumed on a daily basis by animals will establish and maintain a therapeutic amount of ivermectin in the bloodstreams of the animals. In this way, the need for periodic dosing with relatively large amounts of drug(s) is completely avoided, yet the beneficial effects of the drug remain. To this end, the feeds should have sufficient heartworm preventative drug therein so that, when a domesticated household pet consumes the feed at a rate of from about 10-40 g of the feed per kg of the consuming pet's weight, the desired therapeutic amount of drug is achieved. [0019] During extrusion processing in accordance with the invention, starting farinaceous feed ingredients are fed into the elongated barrel of an extruder including at least one elongated, axially rotatable, helically flighted screw with an endmost extrusion die. During passage through the extruder barrel, the ingredients are subjected to elevated temperature, agitation and shear in order to cook the product. In preferred forms of the invention, the starting ingredients are first preconditioned prior to passage into the extruder barrel. Generally, during preconditioning the starting mixture is subjected to a temperature of from about 20-98° C. (more preferably from about 90-97° C.) for a period of from about 15-600 seconds (more preferably from about 170-190 seconds). The purpose of preconditioning is to initially moisturize and partially cook the starting material prior to entrance thereof into the extruder barrel. Advantageously, the material leaving the preconditioner has a moisture content of from about 10-60% by weight, and more preferably from about 21-23% by weight. [0020] In the extruder, the preconditioned starting material is subjected to conditions of elevated heat, pressure and shear. Normally, the temperature conditions in the barrel are such as to achieve a maximum temperature of from about 20°-175° C., and more preferably from about 65-120° F. Normal maximum pressure conditions are from about 100-500 psi, and more preferably from about 150-300 psi. Residence times in the extruder barrel usually range from about 3-180 seconds, and more preferably from about 20-40 seconds. [0021] The heartworm preventative drug content of the extruded feeds can be added at a variety of locations during the process. One preferred technique is to prepare a dilute drug solution which can be pumped at a known rate into the farinaceous ingredients during processing. For example, the drug liquid may be added at the preconditioner, preferably adjacent the outlet thereof. Alternately, the drug may be injected directly into the extruder barrel during processing. Given the relatively small quantities of drug employed in the feeds, it is generally important that there be sufficient time in the process to adequately mix in the drug substantially uniformly throughout the other ingredients. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0022] The following examples set forth presently preferred methods for the production of heartworm preventative drug-containing pet foods and related information. It is to be understood, however, that these examples are provided by way of illustration and nothing therein should be taken as a limitation upon the overall scope of the invention. EXAMPLE 1 [0023] In this example, an ivermectin-containing dog food product was produced using a co-extrusion process. The dry farinaceous ingredients used in this example were (all percentages on a weight basis): wheat flour—14%; rice flour—15%; corn flour—32%; corn gluten meal—12%; poultry meal—8%; brewer's yeast—2%; sodium bicarbonate—0.6%; Thoxyquin—0.1%; potassium sorbate—0.3%; and sugar—5%. The liquid co-extruded mixture contained (all percentages on a weight basis: poultry fat—81.13%; GP (Glutamine Peptide)—11.32%; cheese powder—3.77%; and poultry meal—3.77%. [0024] The extrusion equipment included a Wenger X-85 single screw extruder with a Wenger Model 7 DDC preconditioner. The extruder barrel was made up of a series of interconnected heads. The screw configuration, dies, adaptor parts, preconditioner shafts and beater elements were all Wenger equipment. [0025] In order to effect the desired co-extrusion, a delivery pipe having approximately a ⅜″ delivery nipple was inserted into the center of the die so that the liquid portion was directed through the die with a surrounding annulus of the extruded farinaceous mixture. The liquid portion was pumped through the delivery pipe at a rate which was approximately 30% of the extrusion rate of the farinaceous mixture. At the outlet of the extruder die, the product was cut using an knife and respective samples of the cut product were manually crimped using a hand-crimping tool. In this fashion, “pillows” of the pet food were obtained, with an outer farinaceous ingredient shell and an inner flowable filling containing ivermectin. [0026] Following this treatment, the product was dried to a moisture level of less than 10% by weight. Three samples from the dryer were subsequently frozen and another sample was placed in a plastic bag and stored at room temperature, for a period in excess of six months. [0027] The following table sets forth the illustrative preconditioning and extrusion information. TABLE 1 DRY RECIPE INFORMATION Dry Recipe Rate kg/hr 93 Feed Screw Speed rpm 11 PRECONDITIONING INFORMATION Preconditioner Speed rpm 485 Steam Flow to Preconditioner kg/hr 8 Water Flow to Preconditioner kg/hr 21 Preconditioner Discharge Temp. ° C. 66 EXTRUSION INFORMATION Extruder Shaft Speed rpm 516 Extruder Motor Load % 75 Control/Temperature 2nd Head ° C. 40 Control/Temperature 3rd Head ° C. 51 Control/Temperature 4th Head ° C. 39 Control/Temperature 5th Head ° C. 48 Control/Temperature 7th Head ° C. 45 FINAL PRODUCT INFORMATION kg/m 3 350 Extruder Discharge Density [0028] The products resulting from this test were analyzed to determine the content of ivermectin in the samples. In this analysis, each feed sample was ground in a Retsch mill at low speed using a 2 mm grating screen, so that the ground material would pass through a #10 mesh screen. A total of six samples, three frozen and three stored at room temperature, were processed. In each case, three 37.5 g of a sample was placed in a 250 ml bottle and 100 ml of methanol was added. The bottle was capped, the sample was sonicated for 20 minutes and shaken for 1 hour. 40 ml of the extract was added to a centrifuge tube and centrifuged for 5 minutes at 2000 rpm. 20 ml of the supernatant solution was then passed through a alumina column. The first five ml was rejected and the remainder of the liquid through the column was collected as a purified sample. 2 ml of the purified sample was mixed with a 5 ml mixture of acetonitrile:water (1:1), and a solid phase extraction (SPE) was performed in accordance with the procedure described in Doherty et al., Analytical Chemists International, 81:869(4)(1998). 2 ml of the working, 1% ivermectin sample standard was also run through the SPE procedure to determine if any loss of ivermectin was taking place. [0029] All samples from the SPE treatment were evaporated under nitrogen using an analytical evaporator with a water bath temperature of 50° C. The dried samples were reconstituted in 2 ml of HPLC mobile phase for analysis. Two samples were also prepared using 2 ml of the working standard ivermectin solution (containing 0.42 μg/ml) and were run before and after the feed samples. [0030] The HPLC setup consisted of the following: [0031] Gilson 712 HPLC System Controller [0032] Gilson 305 pump, 231 sample injector, 401 dilutor and 115 UV detector [0033] Jones Chromatography column heater set at 30° C. HPLC Analytical column Symmetry C 18 , 5μ 4.6 × 350 mm Mobile Phase Acetonitrile/methanol/water 53/35/7 Flow rate 1 mL/minute UV Detection 245 nm [0034] The results of the HPLC analyses (two injections of each feed sample and two injections of the working standard solution) confirmed that the pet food samples contained very close to the expected content (0.42 μg/kg) of ivermectin. In particular, the average ivermectin content of the three frozen and the ambient-stored samples was 0.43 μg/kg. This demonstrated that storage conditions (frozen versus ambient) had little effect upon ivermectin potency, and an excellent ivermectin stability. EXAMPLE 2 [0035] In this example, an ivermectin-containing dog food was prepared using a Wenger TX-85 twin screw extruder equipped with a Model 16 Wenger DDC preconditioner. The dry ingredients fed to the extruder included (all percentages by weight basis): wheat middlings—18%; meat and bone meal—18%; soybean meal—18%; and corn—46%. In this run, two liquid dispersions were used which contained (all percentages by weight basis): first mixture, propylene glycol—11 lbs and water—11 lbs; second mixture, propylene glycol—48.82%; water—48.82%; red No. 40 dye—1.86%; and ivermectin solution—0.50%. The amount of ivermectin used was calculated to provide a dose of approximately 1121.1 μg of ivermectin per kg of the dog food on a dry basis. The extruder barrel was made up of interconnected heads. The rotating elements within the barrel included extruder shafts and other elements. The extruder was equipped with dies and adaptors, inserts, and a cutting knife with knife blades was used. The foregoing components as well as the preconditioners shafts and beater elements were all Wenger equipment. [0036] In the process, the dry ingredients were fed to the preconditioner where steam and water was added to moisturize and partially precook the mixture. This preconditioned material was then fed to the inlet of the extruder in the usual fashion. The first liquid mixture was added to the outlet end of the preconditioner for passage into the extruder barrel along with the preconditioned material, over a period of about 11 minutes. Thereafter, the colored, ivermectin-containing liquid mixture was added over a period of about 22 minutes. Finally, additional quantities of the first water/propylene glycol liquid mixture was again added, over about 11 minutes. After extrusion, the product was dried in a Wenger dryer operating at 115° C., followed by a cooler pass. The dryer discharge moisture was 6.25%, wb. [0037] Samples were collected of the colored ivermectin-containing dispersion, the raw material mixture, preconditioned material leaving the preconditioner and extruded samples. [0038] The following table sets forth illustrative preconditioning and extrusion conditions. TABLE 2 DRY RECIPE INFORMATION Dry Recipe Moisture % wb 9.56 Dry Recipe Density kg/m 3 570 Dry Recipe Rate kg/hr 2618 Feed Screw Speed rpm 205 PRECONDITIONING INFORMATION Preconditioner Speed rpm 250 Steam Flow to Preconditioner kg/hr 224 Water Flow to Preconditioner kg/hr 362 Preconditioner Additive 1 Rate kg/hr 57 Preconditioner Discharge Temp. ° C. 90 EXTRUSION INFORMATION Extruder Shaft Speed rpm 700 Extruder Motor Load % 67 Steam Flow to Extruder kg/hr 84 Water Flow to Extruder kg/hr 112 Control/Temperature 1st Head ° C. 50/57 Control/Temperature 2nd Head ° C. 50/86 Control/Temperature 3rd Head ° C. 40/52 Control/Temperature 4th Head ° C. 40/75 Head/Pressure kPa 900 Knife Drive Speed rpm 905 FINAL PRODUCT INFORMATION Extruder Discharge Density kg/m 3 368 Extruder Performance Stable [0039] The dog food from this run was fed ad libitum to an intact female mixed breed dog weighing about 10 kg. On day 7, blood was drawn from the dog four hours after eating and stored in an anti-coagulant tube with calcium EDTA in a refrigerator. Seven days later, the same dog was again fed the ivermectin-containing feed ad libitum and blood was collected four hours post-feeding. This sample was also refrigerated in the same fashion as the first sample. [0040] The blood samples were then analyzed to determine the content of ivermectin therein, using HPLC. The procedure used was described in Dickinson, Journal of Chromatography, 58:250-257 (1990). In this procedure, 0.5 ml of each blood sample was purified using solid phase extraction (SPE) cartridges and dissolved in a small volume of mobile phase for injection onto the HPLC column. The method has a limit of detection of about 2 ng/ml and uses an internal standard. After preparation of the internal standard, a standard curve is constructed using ivermectin-spiked blood samples. A known 1% ivermectin sample was used as the primary standard. [0041] The blood samples from the dog were then analyzed for ivermectin content with HPLC peak heights corrected using the internal standard. The HPLC setup consisted of the following: [0042] Gilson 712 HPLC System Controller [0043] Gilson 305 pump, 231 sample injector, 401 dilutor and 115 UV detector [0044] Jones Chromatography column heater set at 56° C. HPLC Analytical column: Coulter-Beckman UltraSphere XL C 18 , 3μ, 4.6 × 70 mm Mobile Phase: Acetonitrile/methanol/water 49/33/18 Flow Rate: 1 mL/minute UV Detection: 245 nm [0045] The results of this study demonstrated that the dog blood samples contained ivermectin in the range of about 5-8 ng/ml. EXAMPLE 3 [0046] In this example a series of extrusion runs were performed to determine the consistency of metering of ivermectin into a dog food mixture during extrusion. In each case, the farinaceous mixture included the following ingredients (all percentages on a weight basis): corn—35.93%; poultry meal—28.94%; rice—22.95%; corn gluten meal—11.98%; vitamin premix—0.10%; and mineral premix—0.10%. Three ivermectin-containing liquids were prepared, containing: Recipe #1, propylene glycol—8.60 pounds; water—8.60 pounds; red #40 dye—160 grams; ivermectin solution—0.212 ml; Recipe #2, propylene glycol—8.60 pounds; water-—8.60 pounds; red #40 dye—160 grams; ivermectin solution—0.433 ml; Recipe #3, propylene glycol—8.60 pounds; water—8.60 pounds; red #40 dye—160 grams; ivermectin solution—1.279 ml. In each run 8.0 kg of a respective ivermectin recipe was added to the farinaceous ingredients at the exit of the preconditioner, prior to entering the extruder barrel. The recipes were added at a rate equal to 2% of the farinaceous mixture rate. The target for the runs using Recipe #1 was 6 μg ivermectin/kg of feed; for runs using Recipe #2, 12 μg/kg; and for runs using Recipe #3, 36 μg/kg. [0047] The extruder system employed was a Wenger model TX 57 twin screw extruder with a model 2 DDC preconditioner. The extruder barrel was equipped with an extrusion die, a knife assembly was used to cut extrudate. [0048] The following table sets forth the preconditioning and extrusion information collected during this series of runs. In runs 101-103, Recipe #1 was used; in runs 104-106, Recipe #2 was used; and in runs 107-109, Recipe #3 was used. As the extrudates emerged from the die, they were cut using the knife assembly and dried in a Wenger multiple-pass drier. Samples were collected at 15 minutes, 30 minutes and 45 minutes from the preconditioner, extruder and drier. TABLE 3 101 102 103 104 105 106 107 108 109 DRY RECIPE INFORMATION: Dry Recipe Density kg/m 3 494 494 494 494 494 494 494 494 494 Dry Recipe Rate kg/hr 400 400 400 390 392 390 387 397 392 Feed Screw Rate rpm 48 53 55 49 52 52 56 54 54 PRECONDITIONING INFORMATION: Preconditioner Speed rpm 350 350 350 350 350 350 350 350 350 Steam Flow to Preconditioner kg/hr 36 35.8 35.9 36.1 35.9 35.8 36 36.1 35.9 Water Flow to Preconditioner kg/hr 48 48.1 48.3 T47.7 47.9 48.1 48 48.2 48.1 Preconditioner Additive 1 Rate kg/hr 8 7.9 8.05 7.8 7.95 7.84 8.12 8.03 8.02 Preconditioner Discharge Temp. ° C. 86 85 85 86 86 86 85 85 85 Moisture Entering Extruder % wb 16.26 17.04 19.14 18.96 16.47 18.18 16.14 18.97 18.98 EXTRUSION INFORMATION: Extruder Shaft Speed rpm 426 427 425 427 426 426 426 426 425 Extruder Motor Load % 53 45 61 54 52 67 49 51 52 Steam Flow to Extruder kg/hr 12 13.1 709 8 7.9 8 8.1 8 8 Water Flow to Extruder kg/hr 24 24 24.1 24 24 23.8 24 24 23.9 Control/Temp. 1st Head ° C. 40/52 40/52 40/52 40/53 40/55 40/52 40/53 40/55 40/54 Control/Temp. 2nd Head ° C. 60/60 60/60 60/59 60/60 60/60 60/59 60/59 60/59 60/60 Control/Temp. 3rd Head ° C. 80/79 80/80 80/81 80/80 80/80 80/81 80/80 80/80 80/79 Control/Temp. 4th Head ° C. 60/67 60/67 60/67 60/65 60/65 60/66 60/65 60/65 60/64 Head/Pressure kPa 1710 1600 1980 1660 1770 1910 1960 1980 1830 Knife Drive Speed rpm 1324 1324 1325 1492 1443 1493 1493 1492 1491 FINAL PRODUCT INFORMATION: Extruder Discharge Moisture % wb 20.43 19.79 20.4 21.32 21.46 21.97 22.12 22.83 22.71 Extruder Discharge Density kg/m 3 312 374 338 400 349 352 336 336 400 Extruder Performance Stable Stable Stable Stable Stable Stable Stable Stable Stable Dried Product Moisture % wb 2.75 2.12 4.67 9.38 9.74 10.18 7.45 9.4 8.0 [0049] The dried samples were analyzed to determine ivermectin content, using the technique described in Example 1. The results from the Recipe #1, #2 and #3 runs were averaged, with the following results. For the Recipe #1 runs (101-103), the ivermectin content was 6.02 μ/kg (dry basis); for the Recipe #2 runs (104-106), the ivermectin content was 11.99 μg (dry basis); and for the Recipe #3 runs (107-109), the ivermectin content was 35.98 μ/g (dry basis). This confirms that the processing technique of this Example gives extremely close ivermectin contents, as compared with the pre-extrusion goals.

1a

BACKGROUND OF THE INVENTION [0001] Alopecia (e.g., male pattern baldness), is primarily a cosmetic problem in humans, stemming from a deficiency of terminal hair; which is the broad diameter colored hair that is readily seen. In the so-called bald person there is a noticeable absence of terminal hair; however, the skin does contain vellus or fine colorless hair which may require microscopic examination to determine its presence. Current treatments for alopecia and other hair growth disorders include those seeking to convert the fine colorless vellus-like hairs into thicker, broader terminal hairs. One such treatment was serendipitously discovered by Dr. Charles A. Chidsey III. [0002] Dr. Charles A. Chidsey, III discloses and claims in U.S. Pat. No. 4,139,619 the use of minoxidil, 6-amino-1,2-dihydro-1-hydroxy-2-imino-4-piperidinopyrimidine, and related 6-amino-4-(substituted amino)-1,2-dihydro-1-hydroxy-2-iminopyrimidines as a means for (a) increasing the rate of growth of terminal hair, and (b) converting vellus-like hair to growth as terminal hair. (Many, but not all of the compounds considered to be “related 6-amino-4-(substituted amino)-1,2-dihydro-1-hydroxy-2-iminopyrimidines,” are described in U.S. Pat. No. 3,461,461). Dr. Chidsey III, teaches a process for making pharmaceutical compositions comprising minoxidil, said compositions including Topical Creams, Ointments and Solutions containing oily, unattractive and often harsh solvents. Furthermore, in U.S. Pat. No. 4,596,812 Dr. Chidsey III and Dr. Guinter Kahn disclose and claim the use of minoxidil as a therapeutic agent to treat alopecia and arrest and reverse male pattern alopecia. [0003] It is well established that the effectiveness of topical Minoxidil and related 6-amino-4-(substituted amino)-1,2-dihydro-1-hydroxy-2-iminopyrimidines, (“Minoxidil Derivatives”) (hereinafter, both minoxidil and Minoxidil Derivatives will be referred to as “Minoxidil”), in treating male pattern baldness is dose dependant, thus it is desirable to deliver a pharmaceutical composition comprising high percentages of Minoxidil. However, Minoxidil has poor solubility in water and ethanol, and thus the dose of Minoxidil in solutions remains relatively low. Thus, the Minoxidil solutions of the prior art comprise a maximum of 5% to 6.5% Minoxidil, depending on the solvent used. As the term is commonly used in the art, a solution is a watery, runny composition, that will either quickly dry or will evaporate once applied. The prior art addresses the Minoxidil solubility problem by making heavy, oily creams and lotions comprising up to 20% Minoxidil. These creams, lotions and ointments generally contain calamine, wool fat and the like to hold the higher percentage of Minoxidil. One of the biggest problems with these heavy, oily creams, ointments and lotions is that they are cosmetically unattractive when applied to the hair. [0004] In both U.S. Pat. No. 4,139,619 and U.S. Pat. No. 4,596,812, Drs. Chidsey III and Kahn disclose a solution wherein the Minoxidil comprises at most 0.5 to 5% of the total solution in a 12% polyethylene glycol base. Thus, Chidsey III's and Kahn's, solutions comprising these ingredients, as well as those currently marketed only contain up to 5% Minoxidil. [0005] Chidsey III further describes pharmaceutical compositions comprising greater than 5% Minoxidil; however, these formulations require more heavy bases like wool fat, calamine, liquid petroleum and the like, thereby forming creams, ointments or lotions comprising up to 20.0% Minoxidil. While the heavy, oily lotions and ointments are capable of maintaining up to 20% Minoxidil, the high percentages of liquid petroleum or wool fat needed to achieve such percentages is cosmetically undesirable. Baldness treatments requiring the addition of a grease to be worn in the hair for a substantial amount of time would appeal to only a small subset of the balding population, if to any at all. [0006] Numerous other formulations comprising Minoxidil have been published, and, as seen with Chidsey III, when the amount of Minoxidil is greater than 5%, these formulations must also resort to using heavy, oily bases, to keep the Minoxidil in solution. Thus, there is a desire in the art to have a highly effective hair growth formulation that does not have the undesirable look, feel and side effects associated with the lotion, cream and ointment formulations currently available and that allows for enhanced penetration of the active ingredient to those areas where the solution is applied. [0007] U.S. Application No. 20020172649 to So, et al. describes a pharmaceutical composition comprising: at least 5% Minoxidil; a water-based or an alcohol-based solvent; and a propylene glycol co-solvent. In the described pharmaceutical composition, the pH of said composition is adjusted to between 1.0 and 7.0 by addition of an acid, thereby solubilizing the Minoxidil into the solvent/co-solvent system. For lotions, the application method solubilizes up to 12% of the Minoxidil. Solutions of the application use a co-solvent system wherein one of said co solvents is propylene glycol. Propylene glycol causes local irritation and hypersensitivity where applied to the skin. (See, Katzung, B. G., Basic and Clinical Pharmacology McGraw/Hill, Eighth Ed. Page 1059; Catanzaro, J. M., et al., Propylene Glycol Dermatitis, J. Amer. Acad. Dermatol, (1991) 20: 90-5; Warshaw, T. G., et al., Studies of Skin Reactions to Propylene Glycol, J. Invest. Dermatol. (1952) 19: 423-9.) Thus, there is a need in the art for pharmaceutical compositions for hair growth comprising high percentages of Minoxidil in a watery runny solution and which will not cause irritation to the skin. [0008] Others have published the use of a pharmaceutical composition comprising Minoxidil used in conjunction with a co-active ingredient as a method for improving upon the rate of hair growth and vellus to terminal hair conversion. The general idea behind these combination therapies is to supplement the Minoxidil dose response curve with an additional hair growing agent (“co-active ingredient”) thereby bypassing the deficiency in said dose response curve caused by Minoxidil's poor solubility in water and alcohol. [0009] U.S. Pat. No. 5,183,817, issued to Bazzano, teaches a combination of Minoxidil and retinoic acid for the treatment of hair loss. Bazzano's comparative studies show that the addition of retinoic acid to pharmaceutical compositions comprising Minoxidil improved the hair growth response, thus accenting the dose response curve of Minoxidil alone. Bazzano discloses lotions and ointments having 0.5% to 10.0% Minoxidil admixed with retinoic acid; however, said lotions and ointments comprise cosmetically unacceptable heavy or oily bases, and up to 50% propylene glycol, a known skin irritant. [0010] A further example, U.S. Pat. No. 5,026,691, issued to Kligman, teaches a combination of Minoxidil and an anti-inflammatory agent (specifically, hydrocortisone) for treating hair loss. Kligman's comparative studies show that the addition of hydrocortisone to pharmaceutical compositions comprising Minoxidil improved the hair growth response, thus accenting the dose response curve of Minoxidil alone. Kligman discloses pharmaceutical compositions made using the methods of Chidsey III (e.g., comprising propylene glycol), a known skin irritant, and comprising both Minoxidil and hydrocortisone. [0011] In U.S. Pat. No. 5,059,606 to Grollier et al, is disclosed a combination of calcium antagonists (which in themselves neither induce nor stimulate hair growth nor slow hair loss) with certain pyrimidine derivatives to induce and stimulate hair growth and to ameliorate the slowing of hair loss. Grollier discloses that the combination of calcium agonist with pyrimidine derivative acts more quickly than does the pyrimidine derivative alone, and thus the combination allows for a greater hair growth effect using low concentrations of the pyrimidine derivative. In the disclosed combinations, Grollier et al use a propylene glycol base, and a maximum 3% Minoxidil concentration. [0012] Thus, there is a need in the art to increase the concentration of Minoxidil in an efficient, penetrating solution to achieve a highly effective dose of Minoxidil without formulating heavy, oily and cosmetically unattractive creams, lotions and/or ointments; and with out relying on the irritating solvents of the prior art. To satisfy this need in the art, it is necessary that a solution of Minoxidil achieve a greater response along the Minoxidil dose-response curve, and is in a thin, watery, runny, liquid solution rather than a cosmetically undesirable heavy, oily cream, lotion or ointment. Additionally, the need in the art requires that the increased concentration of Minoxidil is preferably not included in a solution that also includes skin irritants, such as propylene glycol and other known irritants. There is a further need for thin, watery, runny, liquid solutions with increased concentration of Minoxidil and comprising co-active ingredients for a still greater hair growing effect. [0013] Accordingly, it is an object of the present invention to overcome one or more of the difficulties and deficiencies related to the prior art. These and other objects and features of the present invention will be clear from the following disclosure. BRIEF SUMMARY OF THE INVENTION [0014] The current invention provides novel solutions comprising a high percentage of a piperidinopyrimidine derivative, more particularly minoxidil. Using the compositions and methods of the current invention, Applicant has made a highly effective, non-oily solution for facilitating hair growth that comprises a high concentration of Minoxidil, that is not cosmetically unattractive when applied to a treatment area and that does not cause skin irritation in the treatment area. In another aspect of the invention, said solution comprising high percentage Minoxidil may further comprise co-active ingredients, such as azelaic acid. [0015] The present invention also provides a method for stimulating the growth of hair or for preventing hair loss in humans and lower animals. The solutions of the current invention are topically administered to an application situs to increase the rate of terminal hair growth, stimulate the conversion of vellus-like hair to grow as terminal hair and to help prevent the loss of existing terminal hair. The present invention finds application in all mammalian species, including both humans and animals. In humans, the compounds of the subject invention can be applied for example, to the head, pubic area, upper lip, eyebrows, and eyelids. In animals raised for their pelts, e.g. mink, the compounds can be applied over the entire surface of the body to improve the overall pelt for commercial reasons. The process can also be used for cosmetic reasons in animals, e.g. applied to the skin of dogs and cats having bald patches due to mange or other diseases. DETAILED DESCRIPTION OF THE INVENTION [0016] By “topical administration”, as used herein, is meant directly laying on, applying to or spreading on outer skin (membrane epidermal tissue) or hair. [0017] By “application situs”, as used herein, is meant a localized area where it is desired that hair growth be stimulated. In humans the application situs can, for example, be on the head, pubic area, upper lip, eyebrows and eyelids. In animals raised for their pelts (for example, mink) the application situs can be over the entire surface of the body to improve the overall pelt for commercial reasons. The present invention can also be used for cosmetic reasons in animals, e.g., application to the skin of dogs or cats having bald patches due to mange or other diseases. [0018] As used herein the term “Minoxidil” means 6-amino-1,2-dihydro-1-hydroxy-2-imino-4-piperidinopyrimidine, in either its free base or hydrochloric acid salt, and also means 6-amino-1,2-dihydro-1-hydroxy-2-iminopyrimidines. These compounds, as well as the methods for synthesizing those compounds, are discussed in detail in the following issued U.S. patents, all of which are incorporated herein by reference: U.S. Pat. No. 3,461,461, Anthony et al., issued Aug. 12, 1969; U.S. Pat. No. 3,382,247, Anthony et al., issued May 7, 1968; U.S. Pat. No. 3,644,364, Anthony, issued Feb. 22, 1972; and U.S. Pat. No. 4,139,619, Chidsey III, issued Feb. 13, 1979. [0019] The Minoxidil compounds which form the pharmaceutically-active component of the present invention are known in the art to stimulate the growth of mammalian hair when applied topically and prevent further hair loss. Compositions of the present invention contain a safe and effective amount of the Minoxidil component; preferably the compositions contain from about 0.01% or more or Minoxidil, more preferably from about 0.01% to about 20%, even more preferably from about 5% to about 20%, and most preferably about 15%, of this component. Of course, the level of active component will vary with the nature and cause of the condition being treated, the surface area available for application, the particular vehicle selected, and the precise application regimen. [0020] As used herein, the term “solution” means a watery liquid preparation of soluble chemicals dissolved in solvents such as water, alcohol, and the like. [0021] As used herein, the term “lotion” means semisolid emulsions that contain fully dissolved or suspended substances for external application. [0022] As used herein, the term “ointment” means semisolid dosage form for topical application to the skin or mucous membranes. Typically, ointments are based on petrolatum and do not contain sufficient water to separate into a second phase at room temperature. [0023] As used herein, the term “co-active ingredient” refers to a wide variety of compounds that are used in combination with Minoxidil to accent the hair growth process. Said co-active ingredients are generally added to Minoxidil solutions by those of ordinary skill in the art, and include, but are not limited to: azelaic acid; retinoic acid; nicotinic esters; anti-inflammatories; calcium; and the like. [0024] As used herein, the term “desired pH” refers to any pH of the Minoxidil solution that does not negatively impact the high percentage of Minoxidil in a solution. [0025] The hair growth stimulant composition of the present invention contains 0.01% by mass or more of the active component Minoxidil, with 0.01% to 20.0% being preferable, 5.0% to 20.0% being more preferable, 12.5% to 15% being even more preferable and 15% being most preferable. [0026] Components and methods for making the vehicle of the present invention significantly increase the percentage of Minoxidil that will remain soluble in a solution. As the solvent for dissolving the Minoxidil, said vehicle preferably comprises the trihydric alcohol glycerin. Glycerin is a base used to make hand soap that is a neutral, colorless liquid which freezes to a gummy paste and which has a high boiling point. Glycerin is far less irritating and much less of a sensitizing agent that is propylene glycol. Glycerin dissolves into water or alcohol, but not oils. In the preferred embodiment, the glycerin-Minoxidil mixture is dissolved in a lower alcohol, and more preferably in ethyl alcohol. In addition, many things will dissolve into glycerin easier than they do into water or alcohol, thus glycerin forms the primary solvent of the current invention vehicle, while ethyl alcohol forms the secondary solvent. Glycerin is incorporated in an amount according to the desired range of Minoxidil, with from about 10% to about 20% glycerin being preferable and from about 15% to about 20% being particularly preferable. It is also desirable to add ethanol as a second solvent to the above solvent vehicle. The final composition preferably contains ethanol in an amount of from about 80% or less, depending on the volume of components such as the Minoxidil, the specific acid used for pH adjustments and any optional co-active ingredients such as retinoic acid; nicotinic esters; anti-inflammatories; calcium; azelaic acid; or the like. Although the preferred primary solvent is glycerin, Applicant's methods are also applicable to other solvents including propylene glycol, although the use of such a solvent will result in a watery, runny solution comprising a high percentage of Minoxidil and that is a skin irritant. [0027] In a preferred embodiment of the current invention, the vehicle comprises glycerin, ethyl alcohol and the active ingredient (e.g., Minoxidil). In this embodiment, 0.01% to 20.0% Minoxidil is solubilized in glycerin and ethyl alcohol resulting in a watery solution. [0028] The hair growth stimulant composition of the present invention is preferably prepared by first heating glycerin to a range of between from about 55.deg.C. to about 75.deg.C., and preferably heating said glycerin to about 60.deg.C. Following heating, 0.01% or more of the active component Minoxidil, preferably about 6.5% to about 20% and most preferably about 15% of micronized Minoxidil, is added to the heated glycerin solvent. The heated glycerin and micronized Minoxidil is then mixed and whisked for approximately 10 minutes, or for a sufficient time to obtain a homogenous white slurry. Applicant has discovered that the step of heating the glycerin is useful for solubilizing a higher percentage of Minoxidil into a water like solution than can be achieved using the methods of the prior art. [0029] The heated glycerin/Minoxidil solution is brought to a desired volume by rapidly mixing in a secondary solvent alcohol, preferably a lower alcohol, and more preferably 200 proof ethyl alcohol, and distilled water. While constantly and vigorously stirring, the glycerin/Minoxidil/alcohol/water mixture is heated to a range of between from about 35.deg.C. to about 40.deg.C., and preferably to about 40.deg.C. The glycerin/Minoxidil/alcohol/water solution, which is initially an opaque white solution, will begin to become transparent at about 30 deg.C. and will become totally clear at 40 deg.C. A desired pH is achieved. For example, the pH is adjusted to a range of between from about 3.5 to about 6.5, preferably from about 4.5 to about 6.3, and most preferably to a pH of about 5.7+/−0.3 using any of a number of well known, non-irritating pH adjustors, preferably ascorbic acid, citric acid, hydrochloric acid, lactic acid, phosphoric acid, and the like. When preparing the high concentration Minoxidil solution using this formulation method, the solution of Minoxidil will be a clear or slightly amber and water like colored liquid. [0030] In an alternative embodiment of the current invention, the vehicle comprises glycerin, ethyl alcohol, the active ingredient (e.g., Minoxidil) and a co-active ingredient (e.g., Azelaic Acid). In this embodiment, from about 0.01% to about 20.0% of Minoxidil and from about 0.01% to about 5.0% Azelaic acid are solubilized in the glycerin. Those of ordinary skill in the art will readily substitute in place of the Azelaic Acid numerous other co-active ingredients, including, but not limited to retinoic acid; nicotinic esters; anti-inflammatories; and calcium, without undue experimentation. Such substitutions are well within the spirit of the current invention. [0031] The hair growth stimulant composition of the present invention is preferably prepared by first heating glycerin to a range of between from about 55.deg.C. to about 75.deg.C., and preferably heating said glycerin to about 60.deg.C. Following heating, from about 0.01% or more of the active component Minoxidil, preferably about 6.5% to about 20% and most preferably about 15% of Minoxidil, is added to the heated glycerin solvent. The heated glycerin and Minoxidil is then mixed and whisked for approximately 10 minutes, or for a sufficient time to obtain a homogenous white slurry. [0032] Once a homogenous white slurry is achieved the solution is combined with a co-active ingredient, and is brought to volume using a secondary solvent alcohol, distilled water and a pH adjustor. In a preferred embodiment of this current method, a volume of alcohol, preferably ethyl alcohol 200 proof, and between from about 0.01% and about 5.0% Azelaic acid is added to the glycerin/Minoxidil opaque, white slurry. Distilled water, is added to bring the final solution to a desired volume. The combined mixture is heated to from about 35.deg.C. to about 40.deg.C., preferably about 40.deg.C., and stirred continuously until a homogenous and clear mixture is achieved. A desired pH is achieved. For example, the pH is adjusted to a range between from about 3.5 to about 6.5, preferably from about 4.5 to about 6.3 and most preferably to about 5.7+/−0.3. When preparing the high concentration Minoxidil preparation using this formulation method, the solution of Minoxidil will be a clear or slightly amber colored watery liquid. Applicant has discovered through experimentation that when the final solution of Minoxidil and Azelaic acid is brought above 40.deg.C., the final solution becomes tackier, and thus begins to take on cosmetically undesirable properties. Such is true particularly when azelaic acid is used as the co-active ingredient and pH adjustor. [0033] The methods of Applicant's current invention can be similarly used to make solutions comprising high concentration Minoxidil and other co-active ingredients. By way of example only, using the above methods Applicant has made a 15% Minoxidil solution that further comprises ascorbic acid or phosphoric acid in place of the azelaic acid. In such an example, Applicant added a high percentage of Minoxidil to heated glycerin. Once this slurry was homogenized, Applicant added the Ascorbic acid of Phosphoric acid; brought up the volume of the solution and adjusted the pH. Those of ordinary skill in the art will readily make the necessary alterations of the current description to include numerous other co-active ingredients without departing from the spirit of the current invention. [0034] A further variation anticipated by the current invention is the use of a solvent other than glycerin. Although glycerin is preferred because, among other reasons, is formulates a final solution that is cosmetically attractive, holds a high percentage of Minoxidil in solution and is not a general skin irritant, Applicant has used the methods of the current invention with other solvents for bringing a high concentration of Minoxidil in to solution. By way of example only, Applicant heated propylene glycol and added a high concentration of Minoxidil (up to 20%) to the heated propylene glycol. The final solution using this alternative solvent comprised a high concentration of Minoxidil, optionally a co-active ingredient, and was a cosmetically attractive solution; however, said final solution was also a general skin irritant, thusly not addressing all of the stated problems of the prior art. The advantage to showing Applicant's method is useful with propylene glycol is that those who have used this solvent in the prior art, can use Applicant's inventive method and make cosmetically attractive solutions comprising much higher percentages of Minoxidil without changing over their solvent system. As stated; however, said solutions will retain the skin irritant properties of the prior art. [0035] It is notable that one of ordinary skill in the art will readily perform the methods of the current disclosure in a different order and/or otherwise varying the techniques. [0036] The hair growth stimulant composition of the present invention thus obtained can be used as a suitable topical preparation, preferably as a watery solution; however, one of ordinary skill in the art will readily use Applicants' inventive method to prepare lotions, ointments, aerosols, tonics, creams, gels, and the like. [0000] Method of Use [0037] It will be appreciated that this invention provides a method for stimulating the growth of hair in humans and lower animals. In addition, the compositions of the present invention may be applied to hairy areas to prevent hair loss. The present invention permits the significantly improved topical application of the Minoxidil actives defined herein in an aesthetically acceptable, skin substantive composition, without irritating the skin at the site of application. [0038] Topical treatment regimens according to the practice of this invention comprise applying the compositions herein directly to the skin, i.e., at the application situs, usually one to six times daily. The rate of application and duration of treatment will, of course, depend on many factors. A typical safe and effective usage rate for topical treatment is from about 1 ml to about 10 ml of the total topical composition per square centimeter of skin per application. The skilled artisan will appreciate that this application rate will vary with the desired effect, the condition being treated and its cause, its progress and response, the area involved, the severity and nature of the condition being treated, the precise identity of the Minoxidil and or carriers being used, the presence or absence of penetration-interfering solvents, cosolvents, excipients and lipids, the physical condition of the patient, concurrent therapies being administered, the concentration of the actives or carriers being used, as well as other factors within the particular knowledge of the patient and/or physician within the scope of sound medical judgment. Generally, the compositions of the present invention will be used such that a total of from about 2.5 mg to about 100 mg of Minoxidil will be applied each day. [0039] The compositions can be applied from once every twenty-four hours to once every hour. Application intervals of every 4 hours to every 12 hours are preferred. A treatment regimen of application every 12 hours is particularly preferred because it minimizes the amount of Minoxidil which is applied at any one time while reducing the inconvenience of frequent applications. However, any treatment regimen, which allows a safe and effective amount of Minoxidil to reach the afflicted situs can be employed while using the compositions of this invention. EXAMPLES [0040] The present invention will be described in more detail by the following examples, which should not be construed as limiting the present invention. Example 1 100 ml Solution of 15% Minoxidil [0041] In a first example of the current invention, 100 ml of a 15% Minoxidil solution is prepared using the methods of the current disclosure. Although the steps are described linearly, those of ordinary skill in the art will readily vary the order thereof without exceeding the scope of the current disclosure. [0042] In a glass beaker, 20 ml of glycerin (e.g., Glycerin USP, Cat. No.: G2289, Sigma, St. Louis, Mo.) is heated to 60.deg.C. and maintained at said temperature. 150 grams of micronized Minoxidil (e.g., Minoxidil, Powder, USP, Cat. No.: 8518HP, Voigt Global Distribution, Kansas City, Mo.) is added to the heated glycerin and the mixture is stirred and whisked for about 10 minutes or until a homogenous white slurry is obtained. 70 ml of 200 proof ethyl alcohol is added to the Minoxidil/glycerin slurry and heated to between 30.deg.C. and 40.deg.C., while constantly and vigorously stirring. A desired pH is achieved. In this example, the pH is brought to and maintained at between about 3.5 and 6.5, preferably between about 4.5 and about 6.3, most preferably to 5.7+/−0.3 using 35 mg citric acid, (e.g., Citric Acid, Anhydrous, Granular, USP, Cat. No.: C1133, Voigt Global Distribution, Kansas City, Mo.). The solution is brought to the final desired volume of 100 ml using deionized water (approximately 10 ml). The final product is a clear 15% Minoxidil solution that is neither a skin irritant, nor a heavy, greasy and cosmetically unattractive lotion or ointment. Example 2 100 ml Solution of 15% Minoxidil and 5% Azelaic Acid [0043] In a second example of the current invention, 100 ml of a 15% Minoxidil and 5% Azelaic Acid solution is prepared using the methods of the current disclosure. Although the steps are described linearly, those of ordinary skill in the art will readily vary the order thereof without exceeding the scope of the current disclosure. [0044] In a glass beaker, 20 ml of glycerin (Cat. No.: G2289, Sigma) is heated to 60.deg.C. and maintained at said temperature. 150 grams of micronized Minoxidil (Cat. No.: 8518HP, Voigt Global Distribution) is added to the heated glycerin and the mixture is stirred and whisked for about 10 minutes or until a homogenous white slurry is obtained. 70 ml of 200 proof ethyl alcohol and 50 grams of Azelaic Acid are added to the Minoxidil/glycerin slurry and heated to between 30.deg.C. and 40.deg.C., while constantly and vigorously stirring. The solution is brought to the final desired volume of 100 ml using deionized water (approximately 10 ml). The final product is a clear 15% Minoxidil/5% Azelaic Acid Solution that is neither a skin irritant, nor a heavy, greasy and cosmetically unattractive lotion or ointment. Example 3 100 ml Solution of 20% Minoxidil [0045] In a third example of the current invention, 100 ml of a 20% Minoxidil solution is prepared using the methods of the current disclosure. Although the steps are described linearly, those of ordinary skill in the art will readily vary the order thereof without exceeding the scope of the current disclosure. [0046] In a glass beaker, 20 ml of glycerin (e.g., Glycerine USP, Cat. No.: G2289, Sigma, St. Louis, Mo.) is heated to 60.deg.C. and maintained at said temperature. 200 grams of micronized Minoxidil (e.g., Minoxidil, Powder, USP, Cat. No.: 8518HP, Voigt Global Distribution, Kansas City, Mo.) is added to the heated glycerin and the mixture is stirred and whisked for about 10 minutes or until a homogenous white slurry is obtained. 70 ml of 200 proof ethyl alcohol is added to the Minoxidil/glycerin slurry and heated to between 30.deg.C. and 40.deg.C., while constantly and vigorously stirring. A desired pH is achieved. In this example, the pH is brought to about 3.5 and 6.5, preferably to about 4.5 and about 6.3, most preferably to 5.7+/−0.3 using 35 mg citric acid, (e.g., Citric Acid, Anhydrous, Granular, USP, Cat. No.: C1133, Voigt Global Distribution, Kansas City, Mo.). The solution is brought to the final desired volume of 100 ml using deionized water (approximately 10 ml). The final product is a clear 20% Minoxidil solution that is neither a skin irritant, nor a heavy, greasy and cosmetically unattractive lotion or ointment. Example 4 12.5% Minoxidil in Propylene Glycol and Optionally Comprising a co-Active Ingredient [0047] In a fourth example, the current invention for bringing a high percentage of Minoxidil into solution is described using a propylene glycol solvent. Although propylene glycol is not the preferred solvent for the reasons stated above, Applicants have applied their invention to such a solvent in order to teach a cosmetically attractive solution comprising a high percentage of Minoxidil without requiring those in the art using said solvent to change their solvent system. [0048] Formula: [0049] Phase A: 40.00(v) % w/v Propylene Glycol USP. Phase B: 12.50(w) % w/v Minoxidil USP micronized. Phase C, 39.80(v) % w/v SD Alcohol 40_B 200 proof; 20.00(v) % w/v Benzyl Benzoate USP; 0.20(v) % w/v Benzyl Nicotinate; (optionally) 5.00(w) % w/v Azelaic Acid. [0050] Manufacture: [0051] Phase A was heated to 65.deg.C. and Phase B added to the heated Phase A with good agitation. Agitation continued for approximately 10 minutes or until mixture became homogenous with an opaque white look. Agitation continued as the mixture was allowed to cool to about 45.deg.C. The volume of the mixture was brought up by adding Phase C, which may optionally contain a co-active ingredient (e.g., Azelaic Acid). Mixing was continued until the solution homogenized and a clear, watery solution formed. The final product comprised 12.5% Minoxidil, and optionally comprised Azelaic Acid in a watery, clear solution that was not cosmetically unattractive. [0052] The compositions described in the above examples, as well as other compositions made by those of ordinary skill in the art using the teachings of the current invention are substantial improvements over the current art. The teachings of the current invention allow those of ordinary skill to prepare high dose Minoxidil solutions, which in turn have an improved hair growth response. The high dose of Minoxidil is solubilized in a non-greasy solvent, and thus is not cosmetically unattractive when used in the hair. Furthermore, the solvent of the current invention is not a skin irritant.

1a

CROSS REFERENCE TO RELATED APPLICATIONS [0001] Not Applicable STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT NOT APPLICABLE DESCRIPTION OF ATTACHED APPENDIX Not Applicable BACKGROUND OF THE INVENTION [0002] The present invention relates to meditation surfaces. Meditation is defined here to include such activities as meditation, contemplation, yoga, spiritual activities, worship and prayer. [0003] Several meditation surfaces are known that allow people to assume a comfortable sitting, laying, kneeling, prostration or standing position comfortably while engaged in meditation activities. In prayer houses such as churches, there are comfortable wooden benches, or other seating arrangements, where individuals can pray in a comfortable environment and away from the outdoor elements. In mosques there is end to end carpeting upon which individuals lay their prayer rugs and do their prayers. Even in yoga, there are the rubber yoga mats upon which people do their yoga in comfortable and clean fashion whether indoors or outdoors. [0004] In the distant past early Jews, Christians and. Muslims, as did other early belief systems, prayed barefooted and prostrated directly on the bare ground. Native Americans, too, valued connecting with the earth directly, and drawing healing powers from their contact with the earth during their spiritual rituals. In the case of the prophet Mohamed, there are historical records that he advised Muslims to pray standing directly on the sand, and when the sand was too hot for their foreheads to touch in prostration, he instructed them to put their heads on a few stones that were kept in their hands to keep them cool. He instructed his people not to put any kind of cloth between their foreheads and the ground, such as part of the turbans that men used to wear, or their sleeves, even when the desert sand was uncomfortably hot. This direct earth contact is still pursued today by some traditions. For example, today, some traditions of Islam, place a small piece of dry clean clay called Turbah on their prayer rug, upon which their head touches during prostration. This is done to resemble the old teachings of the religion; and millions of people around the world pray in this fashion today in an attempt to resemble the old teachings of direct contact with the earth during prayer. The current meditation surfaces evolved over time from meditating directly on the ground, as took place in human traditions thousands of years ago, to its current format, which is more comfortable, cleaner and away from the outdoor elements. BRIEF SUMMARY OF THE INVENTION [0005] Among the meditation surfaces known in the art are yoga mats, prayer rugs, church benches and chairs and so on. They are designed for comfort and have evolved over time to their current format for comfort and cleanliness. Furthermore, meditation activities have been moved mostly indoors for comfort and to be shielded from the elements. The known meditation surfaces are typically made out of rubber as in yoga mats, wool or synthetic fiber as in prayer rugs, wood or leather as in church benches, and so on. What the known meditation surfaces have in common is comfort and cleanliness but also they have effectively provided for complete electrical insulation from the earth. People today have not recognized this as a problem, but rather, a fact of life. The present inventors, however, have recognized that making the meditation surface electrically conductive and connecting to grounding means, would resolve this problem. Thus, the present invention provides for meditation surfaces configured in such a way to facilitate electrically grounded meditation. [0006] The current prayer meditation surfaces, while comfortable, have effectively prevented true direct contact with the earth, which was so valued by the early traditions. In the pursuit of advancement, comfort, and protection from the elements, not only has the physical contact with the earth been lost, but also the electrical body connection with the earth has been eliminated. The present invention recognizes that configuring the meditation surfaces in such a way to facilitate electric conductivity and connecting the meditation surface to grounding means, restores the electrical contact and balance with the earth for those meditating on such surface, while still preserving the comfort and cleanliness of being shielded from the elements, if so desired. [0007] Currently, even when shielded from the elements indoors, the human body and mind, at any moment, are being constantly bombarded by invisible Electro Magnetic Fields (EMFs), which are continuously generated by electrical transporting wires, electrical telecommunication towers, various electrical equipment and devices, as well as EMF generated naturally by the atmosphere at all times. These artificial and natural EMFs induce body voltage, in any ungrounded body. The magnitude of the induced body voltage is a function of the magnitude of the EMFs and the distance from the EMF source. This induced body voltage impacts natural chemical as well as natural electrical functions within the human body and brain. [0008] Long term and ongoing body grounding have been theorized to provide health advantages. Meditation Prayer for any individual, if it happens at all, is intermittent and of a short term duration, such that it does not go on all day long and the amount of time spent doing such activity is a small fraction of anyone's weekly activity, if any. Therefore, the importance of grounding during such a sporadic short period of time, is considered of little value for health purposes, and thus ignored by those advocating the health benefits of long term ongoing body grounding. [0009] This invention addresses this lack of grounding problem during meditation, not for any medical or health advantage, that it may or may not provide, but to restore electrical contact and grounding with the earth. Furthermore, removing the induced body voltage and its negative impact on the body and mind, specifically during meditating activities, thus restoring electrical balance precisely during meditation. The problem is solved by one embodiment of the invention by providing a meditation surface comprising electrically conductive material and then connecting it to grounding means to establish electrical grounding. The electrically conductive material can be any conductive material alone or in combination such as conductive fabric, conductive coating, conductive paint, conductive polymer (e.g. plastic/rubber), and other conductive natural and synthetic materials and compounds. The electrically conductive material used for the meditation surface may be placed on top of any other material, including electrically insulating material such as wood, batting, fabric or carpet; and then connected to grounding means, such as a wire connected to the conductive ground outside to electrically ground the conductive meditation surfaces. [0010] This invention thus re-establishes electrical contact with the earth which is currently missing in meditation activities in almost all religious and spiritual traditions around the world. By doing so, this invention also allows individuals to emulate the ancient teachings of being in contact with the earth during prayer and meditation, in at least the electrical contact aspect, which has been lost over the centuries. BRIEF DESCRIPTION OF THE DRAWINGS [0011] The drawings constitute a part of this specification and include exemplary embodiments to the invention, which may be embodied in various forms. It is to be understood that in some instances various aspects of the invention may be shown exaggerated or enlarged to facilitate an understanding of the invention. [0012] FIG. 1 depicts meditation surface of a conductive yoga mat, embodying the principles of the present invention; [0013] FIG. 2 depicts meditation surface of a conductive yoga mat grounded by touching a conductive surface, such as conductive ground, embodying the principles of the present invention; [0014] FIG. 3 depicts meditation surface of a conductive yoga mat grounded by connecting to grounding means, embodying the principles of the present invention; [0015] FIG. 4 depicts meditation surface of a conductive quilt with the top surface conductive, embodying the principles of the present invention; [0016] FIG. 5 depicts meditation surface of a conductive quilt with the top surface conductive connected to grounding means, embodying the principles of the present invention; [0017] FIG. 6 depicts meditation surface of a conductive quilt with the top surface conductive with a conductive extension connected to the conductive surface that can be slipped underneath or placed in such a way to touch a conductive grounded surface, embodying the principles of the present invention; [0018] FIG. 7 depicts meditation surface of a conductive quilt with both the top and bottom surfaces being conductive, electrically connected together by conductive binding or other electrical connection means, touching a surface such as conductive ground, embodying the principles of the present invention; [0019] FIG. 8 depicts meditation surface of a conductive quilt with both the top and bottom surfaces conductive, electrically connected together by conductive binding or other electrical connection means, connected to grounding means, embodying, the principles of the present invention; [0020] FIG. 9 depicts meditation surface of a wooden meditation bench coated painted with electrically conductive material connected to grounding means, embodying the principles of the present invention. DETAILED DESCRIPTION [0021] Detailed descriptions of the preferred embodiment are provided herein. It is to be understood, however, that the present invention may be embodied in various forms. Therefore, specific details disclosed herein are not to be interpreted as limiting, but rather as a basis for the claims and as a representative basis for teaching one skilled in the art to employ the present invention in virtually any appropriately detailed system, structure or manner. [0022] The object of the invention is to do any one or more of the following: to re-establish electrical contact with the earth for those meditating on such surface; to emulate the ancient teachings of being in contact with the earth and being, grounded during meditation, in at least the electrical contact aspect; to remove EMF induced body voltage and restore electrical harmony during meditating activities; to preserve the comfort and cleanliness of being shielded from the elements, if so desired. [0023] Other objects and advantages of the present invention will become apparent from the following descriptions, taken in connection with the accompanying drawings, wherein, by way of illustration and example, embodiment of the present invention is disclosed. [0024] In accordance with a preferred embodiment of the invention, disclosed is an article of manufacture, comprising a meditation surface configured to facilitate electrically grounded meditation. A preferred embodiment of the meditation surface comprising electrically conductive material, and grounding means. Also, in accordance with a preferred embodiment of the invention, a method is claimed comprising meditating while in contact with electrically grounded meditation surface. [0025] Meditation is defined here to include such activities as meditation, contemplation, yoga, spiritual activities, worship and prayer. [0026] Meditation surface is defined here as the outer surface of a constructed apparatus for use during meditation for such activities as seating, laying, standing, or prostration during meditation, where such surface comes in electrical bodily contact with the individual during meditation. Said constructed apparatus excludes metal chairs, metal benches, metal stools or metal bars used during meditation, if they are naturally electrically grounded during meditation without the need for grounding means. [0027] An example of a meditation surface is the part of the yoga mat that comes in contact with the individual doing yoga. Another example of a meditation surface is the part of the praying rug that comes in contact with the individual during praying activities. Another example of a meditation surface is the surface of a chair or bench in a church. [0028] Meditation quilt is defined to include prayer rugs, yoga mats, meditation cushions and meditation pillows. [0029] Meditation seating is defined to include chairs, benches, seats, and stools intended to be used for meditation activity. [0030] Meditation carpeting means include carpeting and rugs of all shapes and sizes made out of natural material such as wool, silk, cotton, other natural fibers and synthetic material such as nylon, polyester, triexta, and polypropylene, where such carpeting means are intended to be used for meditation activity. [0031] Grounding means is defined as any method of establishing electrical contact with the earth or a method of dissipating electrical charges, such as connecting to the ground/earth in an electrical socket indoors or outdoors; another example is electrically connecting to a grounding stake or a large structure for the purpose of dissipating electrical charges. [0032] Conductive material can be in the form of conductive fabric, conductive coating, conductive paint, conductive polymer (e.g. plastic/rubber), conductive natural material, conductive synthetic materials, conductive compounds and conductive alloys. [0033] One embodiment of the current invention depicted in FIGS. 1 , 2 and 3 comprises meditation surface of a yoga mat 1 constructed from a conductive material such as conductive rubber, where it can be placed directly on the earth 2 outside, or connected to grounding means 3 to facilitate electrical grounding while meditating. [0034] Another embodiment of the current invention depicted in FIGS. 4. 5 and 6 is a meditation quilt comprising, top conductive meditation surface 4 , and bottom quilt surface 5 , where top conductive meditation surface can be connected to grounding means 3 , such as a wire connected to an electrical grounding outlet in an electric wall socket. Such top meditation surface will facilitate electrical grounding during meditation when used anywhere, including indoors. Conductive extension 5 can be attached to top electrically conductive meditation surface 4 that can be slipped underneath the meditation quilt or placed in such a way to touch a conductive grounded surface to facilitate electrical grounding. [0035] Another embodiment of the current invention depicted in FIGS. 7 and 8 comprises a meditation quilt comprising a top conductive meditation surface 4 and a bottom conductive surface 8 , such that both top and bottom surfaces are electrically connected together with conductive binding 7 ; where meditation quilt can be placed directly on the earth outside 2 , or connected to grounding means 3 and then used for meditation in comfort, while at the same time facilitating electrical grounding. [0036] The present inventors have found that static dissipative fabrics such as those made out of carbon fibers woven into polyester fabric work well when used as electrically conductive fabric for use in preferred embodiments of the invention. The present inventors also have found that static dissipative fabrics such as those made out of polyester/cotton blend with micro-fine stainless steel fibers work well when used as electrically conductive fabric for use in preferred embodiments of the invention. Other types of static dissipative fabrics, such as those containing copper, silver or other conductive material also worked well for use in the preferred embodiments of the invention. [0037] Another embodiment of the current invention depicted in FIG. 9 comprises a meditation chair/bench surface 9 painted, coated or plated with conductive meditation surface 10 , where such meditation surface can be electrically grounded by grounding means 3 , thus electrically grounding a person meditating while seated on such meditating surface. The present inventors have found that electroconductive coating and paints such as YSHIELD typically used for painting structures, such as bedrooms, to shield from EMF, work well when used as electrically conductive paint on meditation chair to create meditation surface that is electrically conductive. When additional paint, that was not electrically conductive, was applied on top of the YSHIELD paint, the meditation surface remained electrically conductive and the embodiment of the invention continued to function as intended. [0038] Another embodiment of the current invention comprises a conductive meditation surface such as conductive fabric placed on top of an insulated prayer rug or yoga mat where the top meditation surface can be electrically grounded. [0039] Another embodiment of the current invention comprises meditation surface carpeting means in a temple, mosque or church comprising conductive fabric or material where such carpeting means can be grounded by grounding means. [0040] The embodiments of the present invention disclosed include meditation surface configured to facilitate, electrically grounded meditation; meditation surface comprising electrically conductive material, wherein said meditation surface is adaptable for grounding during meditation, the conductive meditation surface can be grounded by connecting to any grounding means; meditation quilt comprising electrically conductive upper material, wherein said conductive top material is adaptable for grounding; meditation quilt comprising electrically conductive top material wherein conductive top material may have an extension made out of conductive material; meditation quilt comprising electrically conductive top fabric connected to electrically conductive bottom fabric, wherein top and bottom fabric is adaptable for grounding; any disclosed embodiment of conductive meditation surface may be grounded by connecting to a grounding means; meditation seating means comprising electrically conductive material, wherein said meditation surface is adaptable for grounding; conductive meditation seating means may be grounded by connecting to grounding means; meditation carpeting means comprising electrically conductive material, wherein said carpeting means is adaptable for grounding; meditation carpeting means may be grounded by connecting to grounding means; meditation article of manufacture comprising electrically conductive meditation surface and grounding means for the purpose of meditating in a state of electric neutrality; meditation article of manufacture comprising conductive fabric constructed is such a way to yield electrically conductive meditation quilt, and grounding means; meditation article of manufacture comprising conductive rubber material constructed in such a way to yield electrically conductive meditation yoga mat, and grounding means; and a method comprising meditating while in contact with electrically grounded meditation surface [0041] The conductive material, conductive top material or conductive bottom material discussed in any of the embodiments of the invention can be made out of any one or more conductive material alone, integrated together, integrated with other nonconductive material as long as electrical conductivity is maintained: such material includes conductive fabric, conductive coating, conductive paint, conductive polymer, conductive natural material, conductive synthetic material, conductive compound, and conductive plating. [0042] The foregoing merely illustrates the principles of the invention. For example, an electrically conductive meditation bracelet can be used as meditation surface, or the grounding means itself can be considered a meditation surface when used directly to facilitate grounding during meditation. [0043] While the invention has been described in connection with preferred embodiment, it is not intended to limit the scope of the invention to the particular form set forth, but on the contrary, it is intended to cover such alternatives, modifications, and equivalents as may be included within the spirit and scope of the invention as defined by the appended claims. It will thus be appreciated that those skilled in the art will be able to devise numerous alternative arrangements that, while not shown in described herein, embody the principles of the invention and thus are within its spirit and scope.

1a

CROSS REFERENCE TO RELATED APPLICATIONS [0001] The present application is related to the co-pending and commonly-owned U.S. patent application Ser. No. 11/198,558 “BIOPSY DEVICE WITH REPLACEABLE PROBE AND INCORPORATING VIBRATION INSERTION ASSIST AND STATIC VACUUM SOURCE SAMPLE STACKING RETRIEVAL” to Hibner et al., filed 08 Aug. 2005, the disclosure of which is hereby incorporated by reference in its entirety. FIELD OF THE INVENTION [0002] The present invention relates in general to biopsy devices, and more particularly to biopsy devices having a cutter for severing tissue, and even more particularly to biopsy devices for multiple sampling with a probe remaining inserted. BACKGROUND OF THE INVENTION [0003] When a suspicious tissue mass is discovered in a patient's breast through examination, ultrasound, MRI, X-ray imaging or the like, it is often necessary to perform a biopsy procedure to remove one or more samples of that tissue in order to determine whether the mass contains cancerous cells. A biopsy may be performed using an open or percutaneous method. [0004] An open biopsy is performed by making a large incision in the breast and removing either the entire mass, called an excisional biopsy, or a substantial portion of it, known as an incisional biopsy. An open biopsy is a surgical procedure that is usually done as an outpatient procedure in a hospital or a surgical center, involving both high cost and a high level of trauma to the patient. Open biopsy carries a relatively higher risk of infection and bleeding than does percutaneous biopsy, and the disfigurement that sometimes results from an open biopsy may make it difficult to read future mammograms. Further, the aesthetic considerations of the patient make open biopsy even less appealing due to the risk of disfigurement. Given that a high percentage of biopsies show that the suspicious tissue mass is not cancerous, the downsides of the open biopsy procedure render this method inappropriate in many cases. [0005] Percutaneous biopsy, to the contrary, is much less invasive than open biopsy. Percutaneous biopsy may be performed using fine needle aspiration (FNA) or core needle biopsy. In FNA, a very thin needle is used to withdraw fluid and cells from the suspicious tissue mass. This method has an advantage in that it is very low-pain, so low-pain that local anesthetic is not always used because the application of it may be more painful than the FNA itself. However, a shortcoming of FNA is that only a small number of cells are obtained through the procedure, rendering it relatively less useful in analyzing the suspicious tissue and making an assessment of the progression of the cancer less simple if the sample is found to be malignant. [0006] During a core needle biopsy, a small tissue sample is removed allowing for a pathological assessment of the tissue, including an assessment of the progression of any cancerous cells that are found. The following patent documents disclose various core biopsy devices and are incorporated herein by reference in their entirety: U.S. Pat. No. 6,273,862 issued Aug. 14, 2001; U.S. Pat. No. 6,231,522 issued May 15, 2001; U.S. Pat. No. 6,228,055 issued May 8, 2001; U.S. Pat. No. 6,120,462 issued Sep. 19, 2000; U.S. Pat. No. 6,086,544 issued Jul. 11, 2000; U.S. Pat. No. 6,077,230 issued Jun. 20, 2000; U.S. Pat. No. 6,017,316 issued Jan. 25, 2000; U.S. Pat. No. 6,007,497 issued Dec. 28, 1999; U.S. Pat. No. 5,980,469 issued Nov. 9, 1999; U.S. Pat. No. 5,964,716 issued Oct. 12, 1999; U.S. Pat. No. 5,928,164 issued Jul. 27, 1999; U.S. Pat. No. 5,775,333 issued Jul. 7, 1998; U.S. Pat. No. 5,769,086 issued Jun. 23, 1998; U.S. Pat. No. 5,649,547 issued Jul. 22, 1997; U.S. Pat. No. 5,526,822 issued Jun. 18, 1996; and US Patent Application 2003/0199753 published Oct. 23, 2003 to Hibner et al. [0007] At present, a biopsy instrument marketed under the tradename MAMMOTOME is commercially available from ETHICON ENDO-SURGERY, INC. for use in obtaining breast biopsy samples. These devices generally retrieve multiple core biopsy samples from one insertion into breast tissue with vacuum assistance. In particular, a cutter tube is extended into a probe to cut tissue prolapsed into a side aperture under vacuum assistance and then the cutter tube is fully retracted between cuts to extract the sample. [0008] With a long probe, the rate of sample taking is limited not only by the time required to rotate or reposition the probe but also by the time needed to translate the cutter. As an alternative to this “long stroke” biopsy device, a “short stroke” biopsy device is described in the following commonly assigned patent applications: U.S. patent application Ser. No. 10/676,944, “Biopsy Instrument with Internal Specimen Collection Mechanism” filed Sep. 30, 2003 in the name of Hibner et al.; and U.S. patent application Ser. No. 10/732,843, “Biopsy Device with Sample Tube” filed Dec. 10, 2003 in the name of Cicenas et al. The cutter is cycled across the side aperture, reducing the sample time. Several alternative specimen collection mechanisms are described that draw samples through the cutter tube, all of which allow for taking multiple samples without removing the probe from the breast. [0009] Even given the many advantages of such multiple sample taking core biopsy devices, in certain applications some surgeons continue to use less expensive biopsy devices guided in real time by an ultrasonic system. These simple biopsy systems omit a full function control console that operates the cutter and vacuum assistance. Instead, a manually controlled hand piece advances a cutter by either stored spring force, a constant pneumatic pressure source, or motor power. Then the surgeon activates a cutter motor to effect the tissue sample. Thus, the surgeon is challenged to maintain the biopsy probe at a desired surgical site while manipulating the patient's breast. [0010] Spring-fired core needle biopsy devices rely upon a firing mechanism that thrusts forward a needle and a cutter to penetrate the tissue and to obtain a tissue sample rather than prolapsing tissue into a side aperture of a probe. Frequently, a surgeon may encounter an area of dense tissue that is more difficult to penetrate than the surrounding tissue during core needle biopsy. In particular, the lesion or tissue mass being targeted in the biopsy procedure may be difficult to penetrate, requiring the physician to push the biopsy needle with considerable force and/or speed in an attempt to penetrate the lesion and collect a sample. [0011] When encountering such an area of dense tissue, it is common for surgeons using the type of firing core needle biopsy device described above to fire the device in order to penetrate the lesion and obtain a sample. However, due to the length of the firing stroke of such devices, which may be as long as 0.75 inches, it is nearly impossible for the surgeon to control the travel of the needle after firing. Consequently, the long needle stroke may cause uncertainty as to the needle tip location post fire. This may cause the surgeon to obtain a sample from the wrong area. In addition to missing the targeted tissue, long firing strokes may cause the needle to puncture the chest wall or pierce the skin, particularly when the targeted area is near the patient's chest wall. Even if the skin is not pierced, the long travel of the needle, along with the likelihood that the needle will be pushed off course by the force of the firing stroke, may lead to needlessly increased trauma for the patient. These spring-fired biopsy devices also yield a single sample per insertion, thus limiting the amount of diagnostic and therapeutic treatment that may be achieved without the increased discomfort and tissue trauma from repeated insertions. Based on surgeons' use of the long firing stroke feature of current devices to aid in penetrating tissue lesions, it is clear that the medical community sees the benefit of firing assistance when inserting a probe to the desired location. [0012] In commonly-owned and co-pending U.S. patent application Ser. No. 11/035,873, BIOPSY INSTRUMENT WITH IMPROVED NEEDLE PENETRATION to Beckman, et al., filed on Jan. 10, 2005, the disclosure of which is hereby incorporated by reference in its entirety, manual mechanisms are disclosed that impart small reciprocating motions to the probe of a core biopsy device to render assistance in penetrating tissue, yet cutting is performed after the probe is properly positioned, thus avoiding taking samples from the wrong location. Moreover, retraction of a cutter tube between severing samples allows for retrieval of multiple samples without having to reinsert the probe through the skin again. A control system that is tethered to a hand piece of this core biopsy system provides vacuum assistance and other motor control algorithms with numerous clinical and safety features incorporated. Generally, the core biopsy device portion of the system is disposable and the control system is reused. [0013] While these multiple sample core biopsy instruments have numerous advantages, it is believed that the diagnostic and therapeutic opportunities of core biopsy procedures would be more widely used if an economical biopsy device without an elaborate control system existed which did not require the disposal of the entire core biopsy device. SUMMARY OF THE INVENTION [0014] The present invention addresses these and other problems of the prior art by providing a biopsy device that has a needle with a probe tube defining a cutter lumen, a sample aperture formed in the probe tube, a barrier defining a first fluid passage and a second fluid passage that both distally-terminate at the sample aperture. A motorized mechanism axially translates a cutter tube within the probe tube across the sample aperture to sever tissue prolapsed therein to axially translate the cutter tube. One of the first and second fluid passages is defined within the cutter tube and the other is defined between an outer surface of the cutter tube and an inner surface of the probe tube. Advantageously, a flush valve assembly responds to a flush control and to the distally positioned cutter tube to couple either the first or second fluid passage to a fluid supply while the other is at a lower pressure so that the needle is flushed. Thereby, tissue debris or coagulated blood may be flushed so that repeated tissue samples may be taken without impediment. However, the saline flush is selectively employed at the user's discretion, providing an economical reduction in the usage of saline and a corresponding reduction in the overall size of the fluid collection reservoir. It is also believed that certain pathology analyses would benefit from not subjecting tissue samples to a saline flush. [0015] In another aspect of the invention, a core biopsy device has a probe assembly with a probe support structure that holds a probe having a side aperture. A cutter tube is slidingly received by the probe and sized to translate across the side aperture to sever prolapsed tissue. A hand piece includes a hand piece support structure having a lateral engaging portion that receives the probe assembly. Thereby, an economical incorporation of a replaceable probe and cutter tube into a laterally mounted assembly allows reuse of a powered hand piece, yet also provides an advantageous saline flush capability of the probe assembly. [0016] In yet another aspect of the invention, a hand piece of a biopsy device has a proximal carriage that is also translated by the lead screw. The proximal carriage selectively actuates, when the distal carriage is distally positioned, a flush valve assembly contained in a probe assembly. A needle of the probe assembly has a cutter lumen for a cutter tube as well as a lateral lumen, both communicating with a side aperture in a probe tube. The same hand piece may instead be engaged to another probe assembly that utilizes the second carriage to actuate a tissue sample retraction mechanism. [0017] In yet a further aspect of the invention, a biopsy system includes a hand-held device that is connected to a static vacuum source and to a fluid supply. The hand-held device includes a housing that is gripped to position a core biopsy probe. Actuating user controls on the housing translates a motor driven cutter that translates within the core biopsy probe to sever tissue that is prolapsed into a sample opening. Vacuum assist valve assembly in the hand-held device responds to positioning of the motor driven cutter to communicate static vacuum pressure from the static vacuum source to prolapse the tissue. Advantageously, a user may select to couple a fluid supply to the core biopsy probe to dispel debris and coagulated blood. [0018] These and other objects and advantages of the present invention shall be made apparent from the accompanying drawings and the description thereof. BRIEF DESCRIPTION OF THE DRAWINGS [0019] While the specification concludes with claims particularly pointing out and distinctly claiming the present invention, it is believed the same will be better understood by reference to the following description, taken in conjunction with the accompanying drawings in which: [0020] FIG. 1 is a left front isometric view from above of a biopsy device with a disposable probe assembly detached from a reusable hand piece; [0021] FIG. 2 is a right aft isometric view from below of the biopsy device of FIG. 1 ; [0022] FIG. 3 is a right isometric view from below the disposable probe assembly of FIG. 1 disassembled to depict components of a vacuum assistance valve assembly and a saline flush valve assembly; [0023] FIG. 4 is a longitudinal, vertical cross sectional view through a probe of the disposable probe assembly of FIG. 1 ; [0024] FIG. 5 is a longitudinal, horizontal cross sectional view through a vacuum assist valve assembly in an initial state (i.e., communicating supply vacuum to the probe to prolapse tissue) of the disposable probe assembly of FIG. 1 ; [0025] FIG. 6 a longitudinal, horizontal cross sectional view through the vacuum assist valve assembly in a distally translated state (i.e., communicating increased pressure such as atmospheric pressure to the probe) of the disposable probe assembly of FIG. 1 ; [0026] FIG. 7 is a longitudinal, horizontal cross sectional view viewed from below through a saline flush valve assembly in an initial, retracted state (i.e., communication allowed between center port of the vacuum assist valve assembly and the probe) of the disposable probe assembly of FIG. 1 ; [0027] FIG. 8 is a longitudinal, horizontal cross sectional view viewed from below through the saline flush valve assembly in a distally translated state (i.e., communication allowed between a saline supply conduit and the probe) of the disposable probe assembly of FIG. 1 ; [0028] FIG. 9 is a left isometric view from above of the reusable hand piece of FIG. 1 with the handle housing shown in phantom to expose the dual carriages distally translated; [0029] FIG. 10 is a right isometric view from below of the reusable hand piece of FIG. 9 with the handle housing shown in phantom; [0030] FIG. 11 is a left isometric exploded view from below of the reusable hand piece of FIG. 1 ; [0031] FIG. 12 is a left isometric view from slightly below the reusable hand piece with the handle housing removed to expose the distally positioned dual carriages and a portion of the disposable probe assembly installed with a generally rectangular cover removed; [0032] FIG. 13 is a bottom view taken along a horizontal cross section through the probe of an assembled biopsy device of FIG. 1 with dual carriages both distally positioned; [0033] FIG. 14 is a left isometric detail view of the dual carriages in opposite translations as initially positioned during engagement of the disposable probe assembly and during insertion into tissue; [0034] FIG. 15 is a bottom view taken in horizontal cross section through a lead screw of the reusable hand piece of FIG. 14 ; [0035] FIG. 16 is a left isometric view of portions of the biopsy device of FIG. 1 depicted to include the dual carriages in the initial position and sleeve union in phantom and also depicted with the probe and pneumatic components of the disposable probe assembly; [0036] FIG. 17 is a left isometric view from below the portions of the biopsy device of FIG. 16 after retraction of the distal carriage; [0037] FIG. 18 is a bottom isometric view of the frame and dual carriage portion of the biopsy device of FIG. 1 with a horizontal portion cutaway made through the pneumatic components of the engaged disposable probe assembly with valving positioned such that vacuum is communicated to the lateral lumen; [0038] FIG. 19 is a bottom isometric view of the frame and dual carriage portion of the biopsy device of FIG. 1 with a horizontal portion cutaway made through the pneumatic components of the disposable probe assembly with valving positioned such that atmospheric pressure is communicated to the lateral lumen; [0039] FIG. 20 is a left side view of the probe assembly of the biopsy device of FIG. 1 taken in longitudinal cross section exposing a cutter tube distally positioned after severing a tissue sample being retracted by vacuum assistance; [0040] FIG. 21 is a left isometric view of portions of the biopsy device of FIG. 1 depicted to include the dual carriages in a distal position for saline flush and sleeve union in phantom and also depicted with the probe and pneumatic components of the disposable probe assembly; and [0041] FIG. 22 is a bottom isometric view of the frame and dual carriage portion of the biopsy device of FIG. 1 with a horizontal portion cutaway made through the pneumatic components of the engaged disposable probe assembly with valving positioned such that saline is communicated to the lateral lumen. DETAILED DESCRIPTION OF THE INVENTION [0042] In FIGS. 1-2 , a biopsy device 10 has a reusable hand piece 12 and a disposable probe 14 that enables economical taking of multiple percutaneous core biopsy samples by accessing a standard medical vacuum pump or wall-mounted vacuum access port (not shown) through an interfacing vacuum conduit 16 . In addition, the biopsy device 10 advantageously incorporates a saline flush capability received from saline supply conduit 17 . In the illustrative version, the reusable hand piece 12 is self-powered and suitable for use in conjunction with ultrasonic diagnostic imaging. The disposable probe 14 reduces the portion of biopsy device 10 that requires protective packaging to avoid contact with sharp surfaces and to keep it sterile prior to use. Further economy is accomplished by reducing the portion of the biopsy device 10 that is disposed as medical waste between uses. Movable components of the disposable probe 14 are advantageously locked until mounted in an access trough 18 formed in a handle housing 20 of the reusable hand piece 12 . It should be appreciated that one or more standard mechanical, pneumatic, or electrical latches (not shown) may be integrated into the biopsy device 10 to secure the disposable probe 14 to the reusable hand piece 12 . [0043] In FIGS. 1-4 , the disposable probe assembly 14 includes a substantially rectangular cover 22 sized to close the access trough recess 18 ( FIGS. 1-2 ). An end slot 24 formed in the cover 20 ( FIGS. 1-2 , 5 - 6 ) is closed by a probe union sleeve 26 attached to an inner surface 27 ( FIG. 1 ) of the substantially rectangular cover 22 . A core biopsy needle (“probe”) assembly 28 passes longitudinally through the probe union sleeve 26 and is formed by a probe tube 30 that includes an underlying lateral (vacuum) lumen 32 that communicates with a side aperture 34 ( FIG. 1 ) via holes 35 ( FIG. 4 ) near a distal opening 36 of the probe tube 30 that is closed by a piercing tip 38 . A cutter tube 40 is sized to closely fit and translate within an inner diameter (i.e., cutter lumen) of the probe tube 30 with a length sufficient to close the side aperture 34 with a proximal end 42 extending from the probe union sleeve 26 to attach to a cutter gear 44 , as depicted in FIG. 1 . [0044] It should be appreciated that the probe tube defines first and second fluid passages that are separated longitudinally within the probe tube and distally communicate with each other at the side aperture 34 . In the illustrative version, the first fluid passage is defined within the cutter tube 40 and the second fluid passage is defined within the lateral lumen 32 that is “hard walled” apart from a cylindrical portion of the cutter lumen of the probe tube 35 . However, for a cylindrical probe tube (not shown), a cutter tube may be axially offset within the cutter lumen of the probe tube such that the cutter tube may separate the first and second fluid passages, especially if the cutter tube need not be retracted for retraction of samples (e.g., vacuum retraction, straw retraction, single sample per insertion devices). [0045] With particular reference to FIG. 3 , sample retrieval tube 46 is received within a proximal opening in the cutter gear 44 and in turn proximally terminates itself at a half cylinder connector 47 positioned proximate to a rear support bracket 49 attached to the generally rectangular cover 22 . As described in the cross referenced application Ser. No. 11/198,558, the half cylinder connector 47 attaches to a moving portion of a sample holding apparatus and the rear support bracket 49 attaches to a stationary portion of the sample holding apparatus (proximal sample stacker 48 ). The relative movement increments a capture mechanism as samples are proximally stacked with vacuum being ported through the half cylinder connector 47 and sample retrieval tube 46 to extract samples from the cutter tube 40 . [0046] With continued reference to FIG. 3 , proximal to the probe union sleeve 26 is an elongate slot 50 that is part of a vacuum assist valve assembly 52 . The cutter gear 44 includes distal and proximal annular recesses 54 , 56 flanking spur gear teeth 58 that engage the reusable hand piece 12 as described below. A more distal annular recess 60 is gripped by a first valve post 62 that is engaged to longitudinally translate in an elongate post slot 64 of a distal portion 66 of a vacuum valve actuator 68 . [0047] In FIGS. 3, 5 , a cylindrical proximal portion 70 of the vacuum valve actuator 68 has distal and proximal O-ring grooves 72 , 73 that respectively retain distal and proximal dynamic O-ring seals 74 , 75 that move within a distally open cylindrical valve bore 76 of a vacuum valve body 78 molded onto an outer surface 79 of the substantially rectangular cover 22 . [0048] In an initial state depicted in FIG. 5 , the vacuum valve actuator 68 is in a retracted position (along with the cutter tube 40 ), allowing communication between a proximal vacuum port 80 and a center vacuum port 82 . In FIG. 6 , distal translation of the vacuum valve actuator 68 enables communication between the center vacuum port 82 and a distal vacuum port 84 . The center vacuum port 82 is attached to a proximal end of a distal vacuum conduit 86 whose other distal end is connected through the rectangular cover 22 to the probe union sleeve 26 ( FIGS. 2-3 ). It should be appreciated that the probe union sleeve 26 includes fluidic passages that communicate between the proximal end of the vacuum lumen 32 and the distal vacuum conduit 86 as allowed by the saline flush valve assembly 87 ( FIG. 7 ). [0049] Returning to the vacuum assist valve assembly 52 of FIGS. 2-3 , 5 - 6 , the distal vacuum port 84 is attached to a hose nib 88 that is exposed to atmospheric pressure. Hose nib 88 may include an air and/or saline filter. Alternatively, hose nib 88 may be connected to a positive pressure source (e.g., fluid pump) or a negative pressure source (e.g., vacuum pump, syringe) to aspirate fluids. Likewise, hose nib 88 may be used to lavage the tissue cavity with saline, pain medication, or bleeding control fluids. The proximal vacuum port 80 communicates through a proximal vacuum conduit 90 to the interfacing vacuum conduit 16 . [0050] In FIGS. 2-3 , 7 - 8 , the flush valve assembly 87 includes a proximally open saline valve bore 92 formed in a saline valve body 94 molded onto the outer surface 79 of the substantially rectangular cover 22 distal to a laterally offset longitudinal slot 96 ( FIG. 3 ) defined in a distal portion of the substantially rectangular cover 22 . [0051] With particular reference to FIGS. 3, 7 , a saline valve actuator 98 includes a distal cylindrical spool 100 that is sized to be slidingly received within the proximally open saline valve bore 92 . A distal O-ring groove 102 that receives a distal saline O-ring 104 and a mid-shaft O-ring groove 106 that receives a mid-shaft saline O-ring 108 are spaced on the distal cylindrical spool 100 to selectively allow communication between a proximal saline port 110 , which is attached to the distal end of the distal vacuum conduit 86 , and a center molded conduit 112 that communicates through the probe sleeve union 26 to the vacuum lumen 32 when the saline valve actuator 98 is proximally positioned, as depicted in FIG. 7 . When the saline valve actuator 98 is distally positioned, as depicted in FIG. 8 , the center molded conduit 112 communicates with a distal saline port 114 that is attached to a proximal end of the saline supply conduit 17 . A proximal end of the saline valve actuator 98 is attached to a saline slot link 116 that longitudinally slides within the laterally offset longitudinal slot 96 extending a proximal carriage engagement member 118 out of the inner surface 27 of the substantially rectangular cover 22 . [0052] With reference to FIGS. 1-2 , 9 - 11 , the reusable hand piece 12 , as described in previously cross referenced U.S. patent application Ser. No. 11/198,558 includes four user controls aligned on a top surface 160 of the housing 20 , specifically from most distal to most proximal: a forward motor rotation key 162 , a reverse motor rotation key 164 , a saline flush key 166 and a slide button 168 for selecting insertion mode or sample taking mode. The keys 162 - 166 control a control circuit 170 , which may include integral power storage (e.g., batteries, fuel cell, etc.) for untethered use. With particular reference to FIG. 11 , the forward motor rotation key 162 causes a DC motor 172 to rotate its motor output shaft 174 in a forward rotation. A slide spur gear 176 includes an internal keyed engagement with a longitudinal key groove 178 on the motor output shaft 174 that allows longitudinal positioning by the slide button 168 . In particular, fore and aft brackets 180 , 182 of the slide button 168 engage distal and aft annular grooves 184 , 186 that flank spur gear teeth 188 of the slide spur gear 176 . [0053] When the slide button 168 is moved distally, the slide spur gear 176 engages a tissue penetration gear 190 that spins on a common shaft centerline 192 forward of a gearbox input gear 196 . Gearbox input gear 196 consists of a distal small gear 198 and a proximal large gear 200 . The tissue penetration gear 190 has spur gear teeth 206 that engage the slide spur gear 176 . A frame post 212 projects proximally from an aft wall 234 of a frame 204 with a strike pin 214 projecting upwardly from the frame post 212 . In FIGS. 11-12 , a circular cam wheel 216 is attached to a distal side of the tissue penetration gear 190 . Rotating the tissue penetration gear 190 urges the strike pin 214 , and thus the frame 204 , proximally. In FIGS. 11, 13 , left and right spring cavities 218 , 220 (when viewed from above), formed longitudinally in distal corners of the frame 204 , respectively receive inwardly projecting left and right tabs 222 , 224 ( FIG. 13 ) from the cover 20 and receive left and right compression springs 226 , 228 . In particular, a distal end of each compression spring 226 , 228 presses against a distal inner surface of the respective spring cavity 218 , 220 . A proximal end of each compression spring 226 , 288 is grounded against a respective tab 222 , 224 of the cover 20 . Thus, the frame 204 is biased distally within the cover 20 . Movement of the frame 204 proximally compresses these compression springs 226 , 228 that thereafter assert a restoring force. [0054] When the slide button 168 is moved proximally, the slide spear gear 176 is moved into engagement with the gearbox input gear 196 , specifically the distal small gear 198 , which engages and turns a translation large input gear 230 whose shaft 232 passes through the aft wall 234 of the frame 204 . The proximal large gear 200 of the gearbox input gear 196 engages and turns a rotation small input gear 236 whose shaft 238 passes through the aft wall 234 . The frame 204 includes a carriage recess 240 , defined between a partition 242 and the aft wall 234 . The carriage recess 240 contains longitudinally aligned left side lead (translation) screw 244 and right-side rotation spur gear 246 that are attached for rotation respectively with the shafts 232 , 238 . The partition 242 is positioned aft of the left and right tabs 222 , 224 of the cover 20 and also defines in part the left and right spring cavities 218 , 220 . [0055] The rotation spur gear 246 engages the cutter gear 44 when the disposable probe 14 is inserted, imparting a rotation as the cutter tube 40 and cutter gear 44 translate longitudinally in response to the rotation of the lead (translation) screw 244 . This translation is caused by lead screw threads 248 . In particular, a distal carriage (cutter carriage) 250 is longitudinally moved on the lead screw threads 248 . Distal and proximal J-hook extensions 252 , 254 project downwardly from the distal carriage 250 to engage the distal and proximal annular recesses 54 , 56 of the cutter gear 44 ( FIG. 3 ). Distal of the distal carriage 250 , a biasing spring 256 urges against the distal carriage 250 , which assists in engagement of the lead screw threads 248 with the distal carriage 250 . [0056] In FIGS. 11 , 14 - 15 , a sliding pin 260 has a proximal carriage sliding pin retainer 266 attached to a proximal carriage 258 . A shaft 264 of the sliding pin 260 also passes through a distal carriage sliding pin retainer 270 attached to the distal carriage 250 . Sliding pin 260 has a proximal end 262 and a distal end 268 to prevent the sliding pin 260 from disengaging from the carriage sliding pin retainers 266 , 270 . A sliding pin spring 272 resides on the sliding pin 260 and is constrained at each end by carriage sliding pin retainers 266 , 270 . [0057] With the components of the reusable handpiece 12 now introduced, a sequence of use of the biopsy device 10 will be described. The disposable probe assembly 14 is installed into the reusable hand piece 12 . In so doing, the distal carriage 250 engages the cutter gear 44 to position (translate) the cutter tube 40 , initially in a distal position as depicted in FIG. 12 . During installation, the proximal carriage 258 engages the proximal carriage engagement member 118 feature located on saline slot link 116 that engages the proximal portion of the saline valve actuator 98 . A proximally stacking sample retrieving device 48 is attached to the disposable probe assembly 14 to provide a pneumatic vacuum bias to the cutter tube 40 and to hold retracted tissue samples. [0058] With the biopsy device 10 assembled, the reusable handpiece 12 is manipulated to insert the piercing tip 38 of the core biopsy needle (probe) assembly 28 into tissue. Penetration of dense tissue is assisted by moving the slide button 168 distally to a “tissue insertion mode” wherein the slide spur gear 176 engages the tissue penetration gear 190 . Depression of the forward motor rotation key 162 turns these gears 176 , 190 causing the circular cam wheel 216 to turn against strike pin 214 that creates proximal longitudinal motion of frame 204 and the attached core biopsy needle (probe) assembly 28 of approximately 0.1 inch at a rotation rate of 7 cycles per second ( FIG. 12 ). Left and right compression springs 226 , 228 provide the restoring distal longitudinal motion to frame 204 and probe assembly 28 as left and right compression springs 226 , 228 are repeatedly compressed between the distal surface of the left and right spring cavities 218 , 220 of the frame 204 and the left and right tabs 222 , 224 of the housing 20 . The restoring distal longitudinal motion to frame 204 and core biopsy needle (probe) assembly 28 result in a corresponding distal motion of piecing tip 38 that assists in penetrating tissue. [0059] With the probe assembly 28 positioned, the slide button 168 is moved proximally to move slide spur gear 176 into engagement with the gearbox input gear 196 . Depression of the reverse motor rotation key 164 causes the distal carriage 250 to retract ( FIG. 17 ). Thereby, the vacuum assist valve assembly 52 ( FIG. 5 ) communicates vacuum through saline flush valve assembly 87 ( FIG. 7 ) of the disposable probe assembly 14 ( FIG. 18 ) through the vacuum lumen 32 to a now open side aperture 34 in the probe tube 30 ( FIG. 4 ) to prolapse tissue. Vacuum is maintained by a lower pressure also communicating through the cutter tube 40 through the proximal sample stacker 48 . Depression of the forward motor rotation key 162 ( FIG. 1 ) distally translates the distal carriage 250 and thus the cutter tube 40 to sever a tissue sample ( FIG. 20 ) as well as shifting the vacuum assist valve assembly 52 to a distal position ( FIG. 6 ) that communicates an increased pressure (e.g., atmosphere) through the saline flush valve assembly 87 ( FIG. 7 ) through the vacuum lumen 32 to the side aperture 34 , allowing the vacuum through the cutter tube 40 to retract the tissue sample ( FIG. 20 ). [0060] At this point or after subsequent sample taking cycles, the surgeon my elect to flush tissue debris or coagulated blood from the vacuum lumen 32 , side aperture 34 and cutter tube 40 of the probe assembly 28 . By further depression of the forward motor rotation key 162 , the distal carriage 250 advances slightly forward, drawing the proximal carriage 258 onto the lead screw threads 248 , and thereafter the distal carriage 250 free wheels. Thereby, the flush valve assembly 87 switches from pneumatically coupling the lateral lumen 32 to the vacuum assist valve assembly 52 to coupling the saline supply (not shown) to the vacuum lumen 32 . Thereby, the vacuum drawn through the cutter tube 40 causes saline (or other liquid provided) to be drawn through the vacuum lumen 32 and into a distal end of the cutter tube 40 and out of the disposable probe assembly 14 , through proximal sample stacker 48 and then into the fluid collection canister (not shown) located near the vacuum pump. When the proximal carriage 250 is not fully distal, the flush valve 87 is positioned proximal of its fully distal position and prevents saline from communicating with the lateral lumen 32 of the probe assembly 28 . [0061] Control implementation may include sensing of the position of the distal carriage 250 such that motor operation stops distal travel of the distal carriage 250 prior to distal translation of the proximal carriage 258 , requiring release of the forward motor rotation key 162 prior to actuating again to indicate a desire for saline flush. Alternatively, a separate override button (not shown) may be used that continues forward rotation of the lead screw 244 to effect the saline flush feature. [0062] It should be appreciated that in the illustrative version, the distal carriage 250 does not freewheel in its proximal-most position. Instead, rotation of the motor is stopped as the distal carriage 250 is about to contact the proximal carriage 258 with closed-loop control based on an encoder (not shown) coupled to the DC motor 172 enabling accurate positioning of the motor output shaft 174 . Alternatively, freewheeling may be incorporated at the proximal-most position of the distal carriage 250 by adding a section of no helical threads to the proximal end of the lead (translation) screw 244 equal to the longitudinal thickness of the distal carriage 250 . By virtue of the foregoing, with one-handed operation, a clinician is able to select between a plurality of ports (e.g., vacuum pressure, atmospheric pressure, saline supply) that can communicate with a side aperture 34 of a needle assembly 28 of core biopsy device 10 . In particular, valve mechanisms are contained on the hand piece that need only selectively port a constant vacuum source without the necessity for a separate, expensive programmed control module. One advantage of such an economical capability is providing “on-demand” saline flush to the side aperture 34 (or distal opening) of the needle assembly 28 . During normal tissue sampling, the side aperture 34 pressure levels transitions from vacuum during cutting to atmospheric pressure while the tissue sample is being transported proximally out of the reusable handpiece 12 . Clearing tissue debris from the needle assembly 28 at the press of a saline push key 166 during the sample ensures proper operation so that the desired number of samples may be taken. [0063] It should be appreciated that any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein, will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material. [0064] While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the spirit and scope of the appended claims. Additionally, each element described in relation to the invention may be alternatively described as a means for performing that element's function. [0065] For example, one or more sensors may be incorporated into the hand piece 12 to sense the actual position of each carriage or to sense the particular disposable probe assembly assembled into the hand piece 12 . [0066] As another example, use of a proximal carriage for saline flush takes advantage of this additional motive device that is dedicated for sample retrieval in other versions of the disposable probe assembly (i.e., straw). In some applications consistent with the present invention where two carriages are not required or desired, an alternative saline valve selection may be incorporated where a separate electromechanical valve actuator may be incorporated that is not driven by the lead screw. [0067] As an additional example, biasing the cutter tube 40 with a vacuum source advantageously assists in both prolapsing tissue as well as retracting tissue samples from the probe assembly 28 . However, applications consistent with the present invention may include reversing the direction of fluid flow through the cutter tube and out of the lateral lumen 32 . In addition, prolapsing of tissue may be alternatively achieved by closing the lateral lumen and allowing the vacuum bias through the cutter tube 40 to effect tissue prolapse. In addition, a pressurized liquid source may be directed by the flush valve assembly to forcibly push out a tissue sample or debris without the assistance of a vacuum bias on the cutter tube. [0068] As yet a further example, while the illustrative versions advantageously utilize a single motor and a single lead screw to translate two carriages, applications consistent with aspects of the present invention may use two motors and two lead screws or one motor selectively coupled to one of two lead screws, each having a carriage. [0069] As yet an additional example, while selective depression of the saline push key 166 provides clinical flexibility, it should be appreciated that the dual carriage lends itself to alternatively mechanizing automatic saline flush after each cutting cycle.

1a

This application is a Continuation under 35 USC 111 of PCT/AU2003/01191 (WO 2004/024242) filed on Sep. 11, 2003 claiming priority of Australian Application No. 2002 951380 filed Sep. 12, 2002. BACKGROUND The present invention relates to improvements in swim fins and flippers and more particularly relates to a swim fin and method of manufacture thereof which includes fin geometry resulting in a more mechanically efficient, economic, flexible, soft, light weight and comfortable fin in comparison to the known fins. The improvements in such fins enable enhanced maneuverability for the swimmer to whose foot or feet the swim fin or fins are attached. The present invention also provides an improved method of fin construction in which layer hardness distribution throughout the fin is more efficient in that there is increased user comfort, improved geometry and more efficient aqua dynamics. PRIOR ART Swimmers such as surfers and body board users commonly attach swim fins to their feet to gain greater maneuverability. This is achieved by kicking which causes the fins to flex and push against the water with greater force than is possible using the feet alone. There are in existence a wide variety of fin designs each having a particular aqua dynamic effect dictated by their flexibility, weight, shape and configuration. Fin flexibility is a function of, the particular construction of the fin and the stiffness of the material used. The shape and contour of a swim fin is largely dictated by its function. Thus, long fins are used in such activities as scuba diving and short fins are used in such activities as surfing where less purchase in the water (or water displacement) is required. The longer the fin, the greater the load on the foot of the wearer but greater the water displacement. The shorter the fin the lower the load on the foot of the wearer and lower the displacement. In fin design the objective is to provide a comfortable fin which reduces wearer effort without compromise to efficiency. Efficiency is related to wearer effort versus mechanical advantage. An efficient fin propels the wearer with maximum thrust but with a minimum of effort. The differences between fin designs can be subtle but a subtle change in design can result in a more or less efficient fin. Another design criterion is foot comfort. This is predominately a function of material softness disposed in the right places so the foot interacts favorably with the rubber of the fin. Ideally, soft compound rubber will be located in areas of the fin which engage the foot and hard compound rubber will be in those areas which require sufficient stiffness to resist excessive flexure during water displacement. Thus, fin design is a compromise between adequate stiffness for propulsion and sufficient softness for wearer comfort. As an example, a known fin is disclosed in U.S. Pat. No. 6,354,894 which teaches a, spear bladed swim fin which enables divers to propel themselves through the water. Spear-bladed swim fins generally provide a lower surface area to a higher perimeter edge length. By reducing the effective surface area of the swim fin, more propulsive force is delivered by the fin for each kick of the diver. Such dispersion of the diver's energy may be particularly advantageous where stationery swimming is required. Additionally, vortices generated during swim kicks may advantageously complement the operation of the swim fin. The spear blade has a large channel through which water can flow to eliminate dead spots on the lee side of the fin. Fork extension stubs present with the foot pocket of the swim fin provide an adjustable means by which the flexing, bowing, and/or geometry of the swim fin blade may be adjusted according to the preferences and/or demands of the diver. Another known fin is disclosed in U.S. Pat. No. 5,533,918 which teaches a swim fin unit for use on the foot of a swimmer, comprising a body defining a foot receptacle that opens endwise forwardly; a first fin structure integral with and extending generally rearwardly of the body to be flexed upwardly and downwardly rearwardly of the body by water pressure; and a second fin structure integral with and extending generally vertically rearwardly relative to the body; wherein the said first fin structure defines a first plane and the second fin structure defines a second plane; the first and second planes intersecting in generally perpendicular relation. With the advancement of scuba diving and snorkeling, swim fins have likewise developed in order to propel the swimmer through the water more efficiently. As with the swimming fins of fish, swim fins for human beings have certain dynamic characteristics, depending upon fin architecture, that provide for different types of propulsion through the water. Most swim fins, particularly those often used in conjunction with body surfing and body board surfing, scuba and skin diving, are bladed fins having edges extending outwardly from a foot pocket. Webbing is present in the form of elastic or plastic webbing that forms a blade by which the diver propels him or herself. Such swim fins often resemble the rounded or truncate caudal fins present on fish. Consequently, such swim fins provide strength, but generally not speed. As a result, skin and scuba divers swimming around reefs and trying to cover longer distances in calm waters must generally work harder in order to propel themselves faster. Additionally, such bladed swim fins are not adjustable and the lateral edges and the blade webbing does generally not provide any adjustment with respect to the foot pocket. In addition to the shape and configuration, the materials and methods of construction determine whether the fin will be efficient in use and comfortable for the wearer. Fins are typically manufactured from layers of different compound rubbers. A soft compound is normally used for the foot housing to facilitate convenient and comfortable insertion of the foot therein and also to prevent abrasion from hard edges. A hard compound is used for the free trailing end blade as this requires a minimum stiffness to displace water without unwanted excessive flexure or bending. The known fins and particularly surfing fins have undergone many changes in geometry over the years each attempting to achieve maximum efficiency (propulsion) for minimum user effort. There is always room for improvement in fin design and method of construction to achieve more improvements in geometry, comfort and user efficiency. INVENTION The present invention provides an improved fin which results in a more economic, flexible, soft, light weight and comfortable fin. It is an object of the invention to provide a method of construction of a fin and a fin produced by that method of construction. It is an object of the invention to provide an improved fin which meets the needs for significantly enhanced maneuverability realized when used by a surfer, swimmer or surf or body board user. It is another object of the invention to provide a more comfortable fin having improved flexibility and without compromise to the economics of manufacture or to aqua dynamic efficiency. According to a method aspect the present invention provides an improved method of construction of a fin in which layers of rubber are preset prior to compression molding. According to a preferred embodiment, prescribed rubber layers which will form a bottom of a fin are set along with layers for a heel strap region. A foot mold is introduced between those layers and upper layers which will form an upper surface of the fin including the foot pouch. In one broad form the present invention comprises a laminated swim fin formed using two or more rubberized layers each having different hardness; the fin comprising; a) a foot body defining a foot receptacle, that includes an opening to receive the foot of a wearer; b) a first region integral with and extending generally rearwardly of the body to be flexed upwardly and downwardly and rearwardly of the body, by action of water when the fin is in use; c) the fin including an outer layer of medium hardness rubberized material; d) an inner layer of soft compound rubber forming the foot receptacle; e) a layer of hard rubberized material; wherein, the layer of hard material is disposed laterally of the foot receptacle. In another broad form the present invention comprises: a swim fin for use on the foot of a swimmer, the fin comprising; a foot body defining a foot receptacle, that includes an opening to receive a foot of a wearer; a fin body integral with and extending from the body of the foot receptacle and which is capable of being flexed upwardly and downwardly during use and responsive to water pressure wherein, the foot receptacle comprises a soft compound rubber and the fin body includes a medium compound rubber; the fin body further comprising lateral hard rubber regions between the medium and soft compounds wherein the hard rubber regions and medium rubber layer combine to form contoured splay rails which contribute to water displacement and propulsion of the user. According to the preferred embodiment the splay rails are symmetrical about a longitudinal axis through the fin. In its broadest for the present invention comprises; a swim fin including a leading end and a trailing end, the leading end including a recess for receiving a foot of a wearer and the trailing end being a free end which displaces water each sweeps through the water; the fin including a laminated construction comprising a first layer of medium hardness rubberized material ; a second layer of hard rubberized material and a third layer of soft rubberized material; wherein the first and second layers envelope said third layer of soft material. In a broadest form of a method aspect the present invention comprises; a method of construction of a swim fin, the method comprising the steps of; a) providing a first layer of medium compound rubberized material; b) placing a pocket mold in apposition to the first layer to allow formation of a foot pocket in the fin; c) applying a layer soft compound rubber about said foot pocket; d) applying a hard compound rubber between said medium compound rubber and said soft compound rubber; e) forming an envelope with said medium compound rubber to retain said foot pocket and said hard compound rubber; f) bonding said soft, medium and hard layers by heat fusion. According to one embodiment of the method aspect, the bonding of layers may be by a combination of heat fusion and compression. In another broad form of a method aspect the present invention comprises: a method of construction of a swim fin using a compression mold, the method comprising the steps of; a) providing at least one layer of rubberized material having a first degree of hardness; b) providing at least one layer of rubberized material having a second degree of hardness and being a harder material that the first degree of hardness layer; c) taking a mold capable of forming a foot cavity in said fin and placing the mold over at least the said at least one layer of rubberized material having a first degree of hardness; d) laying over the foot mold two rubberized layers of either the same or different hardness, e) compression molding all said layers about said foot mold such that at least layers adjacent said mold conform to the shape of said mold and form a foot pocket; f) separating mold parts of said compression mold; g) removing said foot mold from a foot pocket in a so formed fin. The method may comprise the further preliminary step of milling the rubber layers to a predetermined thickness. A preferred (but non limiting) layer thickness would be in the region of 10–15 mm. The layers can be milled to as low as 3 mm thick by running the layers through a rolling machine. Also, each layer may be of varying thicknesses The fin formed by the process according to the invention has a stiff inner hard layer, a medium outer layer of reduced stiffness and a foot pocket of soft rubber. According to a preferred embodiment the fin comprises a first medium layer of a first color, a second layer of a soft rubber layer having a second color and a hard layer of a third color. Preferably the colors of said layers provide an indication of the hardness or stiffness of the layers which comprise the fins. The method comprises the further step, before laying out said layer of medium compound rubber, of guillotining the layer to a shape according to the geometry of the fin required. DETAILED DESCRIPTION The present invention will now be described according to a preferred but non limiting embodiment and with reference to the accompanying illustrations, wherein FIG. 1 shows a plan view of a typical known fin constructed in accordance with prior art methodology; FIG. 2 shows a cross sectional view of a fin constructed in accordance with the prior art. FIG. 3 shows a plan view of a fin constructed in accordance with a preferred embodiment of the invention; and FIG. 4 shows s side elevation view of the fin of FIG. 3 . FIG. 5 shows a cross section across a line A—A as shown in FIG. 3 according to one embodiment. FIG. 6 shows a cross section across a line A—A as shown in FIG. 3 according to an alternative embodiment. FIG. 7 shows a cross section across a line B—B as shown in FIG. 3 according to one embodiment. FIG. 8 shows a schematic arrangement of an assembly for constructing a fin in accordance with the present invention. Referring to FIG. 1 there is shown a plan view of a typical known fin 1 constructed in accordance with prior art methodology. Typically a fin of the type of FIG. 1 is divided into key regions which relate to functionality of the fin. Accordingly, fin 1 comprises a foot pocket 2 disposed in a central region of the fin. Fin 1 also includes a retaining strap 3 which defines an opening 4 through which a users foot is inserted. Retaining strap 3 engages a users heel to retain the foot in foot pocket 2 . Fin 1 further comprises a distal or trailing end 5 which forms the major area of the overall fin. Trailing or distal end 5 is splayed outwards such that it is widest at edge 6 . The broad width at trailing end 5 enable the fin to displace a substantial amount of water when used by a swimmer. FIG. 2 shows a cross sectional view of fin 1 of FIG. 1 taken across a line A—A constructed in accordance with the prior art. As may be seen from FIG. 2 , fin 1 comprises a first hard rubber compound layer 7 which is heat fused with a second softer rubberized material 8 which forms a molded foot pocket 9 which receives and retains a foot of a wearer. This prior art fin is manufactured by fusing the hard layer 7 with the soft layer 8 . The result is a generally hard fin base and a soft upper wall 8 of foot pocket 9 which is flexible enough to enable a wearer to insert the foot and provide foot comfort during use. Typically the known fins include a leading (proximal) end and a trailing end. Intermediate the leading (proximal) end terminating in strap 3 is a foot pocket 2 for receiving and retaining a foot of a wearer; wherein the trailing end has a relatively stiff free end which displaces water each sweep of fin 1 through water. FIG. 3 shows a plan view of a fin 10 constructed in accordance with a preferred embodiment of the invention. Typically a fin of the type of FIG. 3 , as with fin 1 described with reference to FIG. 1 is divided into three key regions which relate to functionality of the fin. Accordingly, fin 10 comprises a foot pocket 12 disposed in a central region of the fin. Fin 10 also includes a retaining strap 13 which defines an opening 14 through which a users foot is inserted. Retaining strap 13 engages a users heel to retain the foot in foot pocket 12 . Fin 10 further comprises a distal or trailing end region 15 which forms the major area of the overall fin. Trailing or distal end 15 is splayed outwards such that it is widest across edge 16 . The broad width at trailing end 15 enables the fin to displace a substantial amount of water when used by a swimmer. FIG. 4 shows a side elevation of the fin of FIG. 3 with corresponding numbering. FIG. 5 shows a cross section taken along a line A—A through fin 10 according to one embodiment and manufactured in accordance with the method aspect of the invention. As shown in FIG. 5 , fin 10 comprises a first medium hardness layer 17 of rubberized material which is heat fused with a second inner layer 18 of softer rubberized material which forms a molded foot pocket 19 which receives and retains a foot of a wearer. Fin 10 further comprises a hard compound rubber 20 which is retained between layers 17 and 18 . The result is a generally medium hardness outer layer, a soft inner layer 18 for foot comfort and lateral hard regions which reinforce generally stiff but flexible splay rails 19 and 21 . According to one embodiment, the invention provides a swim fin including a leading end and a trailing end, the leading end including recess for receiving a foot of a wearer and the trailing end being a free end which displaces water each sweep through the water. Fin 10 is a laminated construction in which soft layer 18 is in apposition with and enveloped by outer layer 17 and hard layer 20 . The method of construction of fin 10 according to one embodiment, generally comprises the following steps. A first layer 17 of medium compound rubberized material is provided which is laid out on a platform after it is cut to the required configuration. Next a pocket mold (not shown) is placed in apposition to first layer 17 to allow formation thereabout of a foot pocket in the fin formed by soft layer 18 . Soft compound rubber layer 18 is disposed about the foot mold ( not shown) to form the foot pocket 19 . Hard compound rubber layer 20 is disposed between soft compound rubber 18 and medium compound rubber layer 17 so that the hard compound rubber layer 20 has a boundary with the soft inner layer 12 and outer medium rubber compound layer 17 . The medium layer 17 may be wrapped over the inner soft layer 18 and hard layer 20 . Each of layers 17 , 18 and 20 are preferably bonded by heat fusion and compression molding techniques. In a preferred embodiment, the fin 10 includes splay rails 21 and 22 formed on each side, the rails comprising respectively upper edges 23 and 24 and respective recesses 25 and 26 . The layers of the fin will typically be specified according to a flow index of the rubberized material layers. The method comprises the further step, before laying out said layer of medium compound rubber, of guillotining the layers so they are cut to size before compression molding. A process for construction of the fin will be described below with reference to FIG. 8 . The fin 10 formed by the process according to the embodiment described with reference to FIG. 5 above has a stiff hard layer, a medium outer layer of reduced stiffness and an inner foot pocket of soft rubber. According to a preferred embodiment the fin comprises a first medium layer of a first color, a second layer of a soft rubber layer having a second color and a hard layer of a third color. Preferably the colors of said layers provide an indication of the hardness or stiffness of the layers which comprise the fins. The fin may be constructed of laminated layers of the same color but it has been found convenient to employ layers of different colors to represent layers of different hardness and also to enhance the visual effect of the finish as layers of different colors undergo migration during compression molding. The foot recess 19 migrates from a wide region tapering to a narrower region at its opposite end wherein the splay rails 23 and 24 are disposed so as to increase the efficiency of travel of the fin through water and the mechanical advantage to the user. The upper edge of the fin is that which is nearest the users ankle and the lower edge is that which is nearest the soles of the users feet. The upper edge extends laterally beyond the lower edge so that contoured recesses 25 and 26 on opposite sides is formed when viewed in cross section. Fin 10 further comprises and inner rails 27 and 28 . The rails 21 and 22 and corresponding recesses 25 and 26 contribute to thrust provided by the fin and increase mechanical advantage. The upper edge rails 21 and 22 are to some extent flexible as a medium compound rubber is used to form the edges. The lower/inner edge rails 27 and 28 may flex to some extent laterally as the upper edge flexes substantially vertically. The cup like recess 25 and 26 formed by the upper and lower edges cause side thrust in conjunction with lateral displacement of water as the fin is maneuvered in an up and down sweep through the water. Due to the unique edge geometry of the fin, the user notices less effort in obtaining thrust in comparison to the known fin configurations. This is in part due to favorable vortices created as the fin undergoes its vertical sweeps through the water and also due to the particular displacement path of the water as the fin sweeps through. The side rails may undergo fine adjustments during manufacture to alter operating parameters such as its flexion, tension, pitch, geometry and/or a combination of each to alter slightly the water flow over the fin and ultimately aqua dynamics of the fin. The rails are preferably U or V shaped and reduce drag on the downward thrust but with lateral stability. FIG. 6 shows a cross section taken along a line A—A through a fin according to an alternative embodiment and manufactured in accordance with a method aspect of the invention. Fin 30 comprises a first inner soft layer 31 of rubberized material which is heat fused with a second layer outer layer 32 of hard rubberized material forming molded foot pocket 33 which receives and retains a foot of a wearer. The result is a generally hard outer layer 32 and a soft inner layer 31 for foot comfort. Fin 30 further comprises lateral hard splay rails 34 and 35 which provide lateral stiffness and also contribute to improved aqua dynamics of the fin. According to an alternative embodiment, layer 35 maybe substituted with either a medium hardness or soft layer. Thus inner layer 31 is in each embodiment a soft layer. Thus the fin according to two embodiments may be constructed from an inner soft layer and an outer medium hardness layer or from an inner soft layer and an outer hard layer. In the context of the invention, outer layers will be stiffer and harder than an inner foot pocket layer. A soft layer is preferably within the range of 35–40 gerometers. A medium layer is between 41–60 gerometers and a hard layer is within the range of 61–75 gerometers. FIG. 7 shows a cross section of fin 10 shown in FIG. 3 taken across line B—B with numbering corresponding to parts in FIG. 6 . Line B—B is closer to the wide tapered end 15 of fin 30 . FIG. 8 shows an exploded view of an assembly 40 for manufacture of a fin in accordance with an embodiment of a method aspect. Assembly 40 comprises upper mold part 41 and lower mold part 42 . Mold part 41 includes a molded recess 43 which has a molded profile of an upper surface of a fin to be made form the mold. Mold part 42 includes a molded outstanding profile 44 which has a molded profile of an upper surface of a fin to be made form the mold. Intermediate mold parts 41 and 42 is a foot mold 45 which allows formation of a foot pocket (such as foot pocket 12 shown in FIG. 3 ). When a fin is to be formed, layers forming an underside of a fin are disposed underneath foot mold 45 . In FIG. 8 there are shown two layers 46 and 47 which will form the underside of a fin. Layer 46 is preferably a hard stiff layer and layer 47 is a soft layer as it will form a tread in a foot pocket of the fin. Abutting layer 46 is a layer 50 of a hard material overlain by a layer of soft material 51 . Soft layer 51 will during compression molding of the fin when mold parts 41 and 42 are joined in opposing relationship migrate through channel 53 to form a heel strap of the fin. Layer 48 is a soft layer which forms an inside upper layer of a foot pocket. Layer 49 is a hard compound layer and forms an outer upper surface of the fin. Once each of the aforesaid layers are set in position compression molding takes place which fuses layers in contact with each other until the fused rubber conforms to the shape of the profiles 43 and 44 and in conjunction with foot mold 45 forms a fin having prescribed parameters. A fin manufactured in accordance with the method of the invention described herein has advantages of stiffness and flexibility with retention of elasticity, reduced weight increased user comfort and softness and potentially improved manufacturing cycle time. The costs of materials may be reduced due to the use of less hard material which is typically more expensive. According to one embodiment of the method aspect, the bonding of layers may be by a combination of heat fusion and compression. The method of construction may comprise the further preliminary step of milling the rubber layers to a predetermined thickness. A preferred (but non limiting) layer thickness would be in the region of 10–15 mm. The layers can be milled to as low as 3 mm thick by running the layers through a rolling machine. Also, each layer may be of varying thicknesses. It will be recognized by person skilled in the art that numerous variations and modifications may be made to the invention without departing from the overall spirit and scope of the invention broadly described herein.

1a

This application is a continuation in part of U.S. patent application Ser. No. 10/338,867, filed on: Jan. 9, 2003 now U.S. Pat. No. 7,128,076. FIELD OF THE INVENTION The invention relates to the area of solar protection coverings and more specifically to the area of automated canopies that provide solar protection. BACKGROUND OF THE INVENTION Skin cancer has become an increased concern due to the depletion of the ozone layer, which protects people from the sun's harmful UV rays. Thus, in order to provide protection from the sun, people now use umbrellas not only to keep themselves dry from rain but also to provide shade from the harmful effects of the sun. Solar umbrellas for providing shade are quite prevalent on patios and other outdoor facilities. Of course, sunscreens can optionally be applied by individuals to block the harmful UV rays, however in some cases this may not be a preferable option, especially when very young infants or those with allergies are involved. Since the chemicals in the sunscreens may react adversely with the skin of young infants or those with allergies. Young infants are especially susceptible to harmful UV rays when they are pushed around in a stroller by their parents. Thus, the strollers are typically equipped with sun shades that are spatially oriented by parents in such a manner to provide sun protection to the infant. Unfortunately, as the stroller is moved, the spatial orientation of a sun shade must typically be varied in order to maintain shade on the infant. Thus, as the stroller is wheeled around the position of the shade on the infant changes; and as a result the parents have to stop pushing the stroller and they have to reposition the sun shade in order to maintain their infant in the shade cast by the sun shade. A need therefore exists for providing an umbrella, which offers solar protection in a shadow cast therefrom, and one that does not require constant manual repositioning as a result of the orientation of the sun changing with respect to the canopy. It is therefore an object of the invention to provide an automated positioning system for a canopy of an umbrella that varies its position in an automated manner to facilitate providing of a shaded area at a predetermined location as the orientation of the sun varies with respect to the canopy. SUMMARY OF THE INVENTION In accordance with the invention there is provided a method of spatially orienting a canopy comprising the steps of: detecting an orientation of a light source relative to the canopy; moving of the canopy in dependence upon the detected orientation, the canopy positioned for providing a shade under the canopy; and, maintaining the shade about an approximately predetermined location relative to which the canopy is moved. In accordance with the invention there is also provided an apparatus comprising: a canopy having an upper surface and a lower surface for providing shade to a shaded area opposing the lower surface in response to light impacting the upper surface; a first photodetector for detecting at least one of an amount of light in the shaded area and an amount of light impacting the canopy upper surface, the detector for generating a photocurrent in response to light incident thereon; a control circuit for receiving the photocurrent and for generating a first control signal in dependence thereon; a positioning mechanism having a fixed portion and having a moving portion coupled with the canopy for spatially orienting the canopy relative to the fixed portion about at least an axis in response to the control signal for, in use, maintaining at least a portion of the shaded area in an approximately predetermined spatial orientation relative to the fixed portion. BRIEF DESCRIPTION OF THE DRAWINGS Exemplary embodiments of the invention will now be described in conjunction with the following drawings, in which: FIG. 1 illustrates a prior art solar umbrella; FIG. 2 a illustrates a prior art variation of a solar umbrella; FIG. 2 b illustrates a resilient portion provided with the prior art umbrella shown in FIG. 2 a; FIG. 3 illustrates a circuit for use with an embodiment of the invention; FIG. 4 illustrates a variation of a circuit for use with an embodiment of the invention; FIG. 5 illustrates an embodiment of the invention; FIG. 6 illustrates a positional change of a canopy from an initial position shown in FIG. 5 to a new position when the canopy is provided with sunlight; FIG. 7 a illustrates a spatial orientation of photodetectors on a canopy; FIG. 7 b illustrates an orientation of a single photodetector on a canopy; FIG. 8 illustrates a dual axis pivot component; FIG. 9 illustrates a variation of the dual axis pivot component shown in FIG. 8 ; FIG. 10 illustrates a stroller equipped with an automated canopy positioning system; and, FIG. 11 illustrates an umbrella having a variation of the dual axis pivot component shown in FIG. 9 . DETAILED DESCRIPTION OF THE INVENTION In FIG. 1 a, a prior art solar umbrella 10 is shown. The umbrella 10 includes a canopy 11 , for providing shade from the sun, an umbrella shaft 12 , and a mechanism (not shown) for allowing movement of the canopy between an open and a closed position. In the open position the canopy provides shade from the sun, and in the closed position the canopy other than substantially provides shade from the sun. The umbrella shaft 12 is coupled to a resilient portion 16 , which is further coupled to a mounting portion 14 for rigidly mounting to a frame member 13 , through the use of a clamping mechanism (not shown). The frame member 13 forms part of a stroller (not shown). The resilient portion 16 is of a type that facilitates maintaining of the spatial orientation of the umbrella shaft 12 with respect to the mounting portion 14 in response to a force applied to the umbrella shaft, where the force is sufficient to overcome the resiliency of the resilient portion 16 . Thus, the resilient portion 16 is movable or malleable to set the spatial orientation of the canopy 11 and to maintain the spatial orientation of the canopy 11 with respect to the frame member 13 during normal use. For instance, when the wind blows the resilient portion 16 allows for some movement of the canopy 11 with respect to the frame member 13 as a result thereof. However, it approximately maintains the spatial orientation of the canopy 11 with respect to the frame member 13 , unless a sufficient force is applied to the umbrella shaft 12 to overcome the resiliency in order to re orient the canopy 11 with respect to the frame member 13 . Thus, when the clamping mechanism (not shown) is fixedly mounted to the frame member 13 as part of a stroller, the umbrella shaft 12 is manually repositioned in such a manner that the canopy 11 provides shade to a shaded area in which, for instance, an infant is seated in the stroller. Effectively, the canopy blocks a portion of the harmful UV rays impacting on the shaded area. Unfortunately, as the orientation of the stroller changes with respect to the sun, the spatial orientation of the canopy 11 must be manually varied in order to re-orient the canopy 11 , such that the shaded area remains shaded. Prior art FIG. 2 a illustrates a variation of a solar umbrella 20 . The umbrella 20 has a canopy 21 and an umbrella shaft 22 . The umbrella shaft 22 is coupled to a moving portion (not shown) of a pivot component 26 having a moving portion and a fixed portion 24 . The fixed portion of the pivot component 26 is for rigidly mounting to a frame member 23 in the form of part of a stroller (not shown). The pivot component is a single axis pivot component 26 , of a design for facilitating movement of the umbrella shaft 22 with respect to the fixed portion 24 about a single axis. The pivot allows for vaying the spatial orientation of the canopy 21 with respect to the frame member 23 in response to loosening of a nut 27 , releasably engaged on a thread. The nut is for selectively frictionally engaging the moving portion with respect to the fixed portion 24 of the pivot component 26 . Thus, by loosening of the nut 27 , the canopy 21 is manually variably spatially orientable with respect to the fixed portion 24 in a spatial orientation about the single axis. Afterwards the nut 27 is tightened to fix the spatial orientation of the canopy 21 with respect to the fixed portion 24 . In accordance with prior art FIG. 2 b, shown is a solar umbrella 200 , a resilient portion 260 is provided between the umbrella shaft 22 and the pivot component 26 in order to facilitate movement of the canopy 21 in response to external forces such as wind, as well as to facilitate spatial orientation of the canopy. The resilience is selected to maintain the canopy 21 with respect to the fixed portion 24 about at least one axis. Unfortunately, as the stroller is moved with respect to the sun, periodic variations in the spatial orientation of the canopy 11 and 21 must be manually performed in order to ensure that the shaded area thereby provided encompasses the infant. Furthermore, if the solar umbrella is for instance used to provide shade to a fixed object in the form of a table, then movement of the sun with respect to the table also causes the shaded area under the canopy to vary in position relative to the fixed object and thus manual reorienting of the canopy is necessary to ensure that the shaded area under the canopy is at a desirable spatial orientation. FIG. 3 illustrates a circuit for use with an embodiment of the invention. The circuit uses a first photodetector 31 to receive light and to generate a photocurrent in response thereto. The photocurrent generated by the photodetectors is received by a control circuit 33 , which is further coupled to an actuator 34 . The control circuit comprises circuitry which determines, from the received photocurrent, a magnitude of light energy impacting on the surface of the photodetector 31 . In dependence on the magnitude of the light energy, a control signal is generated by the control circuit. The control signal is provided to the actuator, wherein the control signal has at least a polarity and preferably is also characterized by a magnitude. FIG. 4 illustrates a variation of the circuit for use with an embodiment of the invention. The circuit uses first and second photodetectors 48 and 49 to receive light, the first and second photodetectors 48 and 49 for generating photocurrents in response thereto. Both photocurrents, provided by the photodetectors, are received by a control circuit 43 , which is further coupled to an actuator 44 . The control circuit 43 comprises circuitry that determines from the received photocurrents a relative magnitude of light energy impacting on the surface of each of the photodetectors 43 , 44 . In dependence upon the relative magnitude of the light energy, a control signal is generated and provided to the actuator 44 . The control signal has at least a polarity and preferably also has a variable magnitude. Thus when the first photodetector 48 receives more light energy than the second photodetector 49 the control signal has a first polarity, and when the first photodetector 48 receives less light energy than the second photodetector 49 the control signal has a second other polarity. The first and second polarities each in response thereto result in the actuator 44 moving in different directions being a first direction and a second other direction, respectively. Optionally, the circuit is solar powered using at least a solar cell 47 . As is evident to those of skill in the art, since the canopy is for use in providing shade, sun energy is typically incident on an upper surface of the canopy during use and, as such, placement of solar cells is straightforward. The control circuit additionally has a circuit that stores electrical energy received from the solar cell in an energy storage medium in the form of a capacitor or a rechargeable battery. Further optionally, the photodetectors act as solar cells and photocurrent therefrom is used to charge an energy storage circuit that is then used to power movement of the actuator in either the first direction or the second other direction. In FIG. 5 , an embodiment of the invention is shown that utilizes the circuit featured in FIG. 4 . In this embodiment an umbrella is provided, the umbrella has a canopy 51 and an umbrella shaft 52 . The umbrella shaft 52 is coupled to a moving portion 501 of a pivot component 56 having the moving portion 501 and a fixed portion 54 . The moving portion 501 is disposed proximate an end of the umbrella shaft opposite the canopy 51 . The fixed portion 54 of the pivot component 56 is for rigid mounting to a frame member 53 . The frame member 53 is for example part of a vehicle, preferably in the form of a stroller (not shown) or part of a stationary object, such as a table. Of course, the rigid mounting may be other than rigidly coupled to the frame member 53 . The circuit assembly has first and second photodetectors 58 and 59 , preferably disposed about an outer surface of the canopy 51 , electrically coupled to a control circuit 57 for providing a control signal to an actuator 55 . Thus in response to a control signal generated by the control circuit 57 , the canopy 51 is spatially oriented about a first axis with respect to the fixed portion 54 by the actuator 55 . The pivot component is preferably at least a single axis pivot component 56 for supporting actuated movement of the umbrella shaft 52 with respect to the fixed portion 54 about at least a single axis with the actuator 55 and circuit assembly as shown in FIG. 4 . Movement about the at least a single axis results in the canopy sweeping out a first arc when the canopy moving portion 501 pivots about the first axis of the pivot component 56 . Alternatively, the first and second photodetectors 58 and 59 are mounted about an other than outer surface of the canopy in such a manner that other than light impacting the outer surface of the canopy is received thereby. Alternatively, at least one of the first and second photodetectors 58 and 59 is mounted below the canopy adjacent a window therein for allowing light to pass therethrough. For example, in a first predetermined mode of operation, the control circuit 57 samples photocurrents provided from the first and second photodetectors 58 and 59 . The control circuit 57 determines relative amplitude between the photocurrents and in response to the determined relative amplitude provides a control circuit for causing the actuator 55 to move the canopy 51 in the direction toward the photodetector providing more photocurrent, until a point is reached wherein the amplitude of the photocurrents generated by each of the photodetectors is approximately equal. Thus, in the first mode of operation, the canopy 51 is spatially oriented in first and second directions in an attempt to equalize the photocurrents generated by each of the photodetectors. Alternatively, different photodetector placement and control criteria are implemented within the control circuit 57 to, for example, position the canopy 51 in such a manner as to detect a least amount of photocurrent. Thus, when the apparatus shown in FIG. 5 is mounted to a moving vehicle frame member 53 using a clamping mechanism as part of the fixed portion 54 , movement of the vehicle with respect to the sun, or other light source, results in automated movement of the canopy 51 with respect to the fixed portion 54 in response to the control signal from the control circuit 57 . One of skill in the art will understand that the movement described above is in response to the control circuit satisfying a design goal of equalizing photocurrents generated by each of the photodetectors. Alternatively, another design goal is implemented when the photodetectors are different or differently oriented relative to the canopy. Referring to FIG. 6 , the sun 601 , or other light source, provides light that is incident on both photodetectors 58 and 59 . Using an initial position as shown in FIG. 5 , the control circuit 57 receives both photocurrents and generates a control signal having such a polarity that the actuator 55 automatically re-positions the canopy 51 , with respect to the fixed portion 54 , in such a manner that the canopy automatically arrives at an other than initial position. In this other than initial position shade from the light source is provided under the canopy between shade lines 602 and 603 , as shown in FIG. 6 . In this other than initial position, each of the photodetectors are illuminated by substantially a same amount of light and movement of the canopy 51 with respect to the fixed portion 54 is approximately stopped. In this approximately stopped position, the control circuit 57 either generates a control signal that changes polarities at a rate that is insufficient to cause substantial displacement of the actuator 55 in either the first or second directions, or the magnitude of the control signal is decreased sufficiently to provide other than sufficient power to move the actuator 55 substantially as the difference in photocurrents observed on each of the photodetectors is approximately zero. Of course, the difference in photocurrents observed on each of the photodetectors is optionally in accordance with other predetermined design goals of the control circuit. Referring to FIG. 7 a, the orientation of a first pair of photodetectors 58 , 59 , and a second pair of photodetectors 78 , 79 are shown. The first pair of photodetectors 58 and 59 are for generating photocurrents that are for use by the control circuit to provide a control signal for positioning the canopy 70 about a first axis and the second pair of photodetectors 58 and 59 are for generating photocurrents that are for use by the control circuit to provide a control signal for positioning the canopy 70 about a second axis. Preferably the first and the second axes are orthogonal one to the other. In FIG. 8 , a dual axis pivot component 86 is shown, mounted to a fixed portion 84 that is mounted to a frame 83 of an object. An umbrella shaft 82 is pivotally mounted to the dual axis pivot component 86 . The dual axis pivot component comprises actuators; the actuator are for pivoting the canopy 70 about a first axis 801 and a second axis 802 , with respect to the fixed portion 84 . Preferably, the photodetectors shown in FIG. 7 a are oriented on the canopy 70 in such a manner that the first pair of photodetectors, photodetectors 88 a and 88 b, are positioned substantially parallel to an arc swept by the umbrella shaft when the umbrella shaft moves about the first axis 801 and that the second pair of photodetectors, photodetector 89 b and another photodetector (not shown), are positioned substantially parallel to an arc swept by the umbrella shaft when the umbrella shaft moves about the second axis 802 . Thus, the umbrella shaft 82 moves about the two orthogonal axes 801 and 802 in response to first and second control signals generated by the control circuit (not shown). The control circuit shown in FIG. 4 is optionally employed and provided with an additional two photodetectors and an additional actuator in order to facilitate movement of the umbrella shaft about the two axes. When the canopy 70 is provided with light from a light source, such as the sun, the first and second control signals provided to first and second actuators, respectively, result in the canopy 70 of the umbrella automatically orienting itself toward the sun in a manner in accordance with predetermined design goals. Preferably, the shaded area under the canopy provides shade in a desired location as a result of the spatial orienting of the canopy 70 with respect to the fixed portion 84 . Alternatively, a single actuator is provided for orienting the canopy about both axes in response to the two control signals. Of course, instead of using the circuit shown in FIG. 4 , optionally the circuit shown in FIG. 3 is utilized with the embodiment shown in FIG. 8 . When using the control circuit shown in FIG. 3 , a single photodetector 72 is provided on the canopy 71 or umbrella shaft (not shown). In this case however, when a single photodetector is used, as shown in FIG. 7 b, it is more difficult to determine in which direction to actuate either of the actuators. As a result, for a single axis, the control circuit stores the photocurrent generated by the photodetector 72 in a current orientation of the canopy 70 , orients the canopy in a first direction, stores the photocurrent generated by the photodetector 72 in this new orientation, then determines whether the stored photocurrent is larger for the orientation of the canopy in the current orientation or the new orientation, and generates a control signal provided to the actuator to position the canopy in such a manner so that the photocurrent generated by the photodetector 72 is in accordance with predetermined parameters set forth within the control circuit. For a dual axis system, this same process is repeated for pivoting of the canopy 70 about the second axis 802 . However, using a single photodetector is less preferable than using two photodetectors per axis. When two photodetectors are employed for each axis, an immediate gradient is observed for that axis by measuring a difference in the magnitudes of each of the photocurrents within the control circuit. Referring to FIG. 9 , a variation of the dual axis pivot mechanism is shown for a solar umbrella for use with a table 908 . A dual axis pivot component is provided between a fixed portion 903 and an umbrella shaft 905 . The fixed portion 903 is mounted to the table 908 . The dual axis pivot component has an intermediate component 904 , thus the umbrella shaft 90 is pivotally mounted to the intermediate component 904 , for pivoting about a first axis 906 with respect to the intermediate component 904 , and the intermediate component 904 is pivotally mounted to the fixed portion 903 for pivoting about a second axis 907 with respect to the fixed portion 903 . Preferably, the first and the second axes 906 and 907 are orthogonal. At an end of the umbrella shaft 905 , other than the end that is pivotally mounted to the intermediate component 904 , a canopy 70 is disposed. The umbrella shaft 905 has a mechanism for allowing movement of the canopy 70 between an open position and a closed position. Two actuators (not shown) are provided for pivoting of the canopy 70 about the first axis 906 and the second axis 907 in response to photocurrents generated by photodetectors 98 a and 98 b (hidden in FIG. 9 ), and photodetectors 99 a (hidden in FIG. 9) and 99 b and photodetectors 58 and 79 (hidden in FIG. 8 ). Preferably the photodetectors such as those shown in FIG. 7 a are oriented on the canopy 70 in such a manner that the first pair, photodetectors 98 a and 98 b, are positioned substantially parallel to an arc swept by the umbrella shaft when the umbrella shaft pivots about the first axis 906 and that the second pair, photodetector 99 b and another photodetector (not shown), are positioned substantially parallel to an arc swept by the umbrella shaft when the umbrella shaft pivots about the second axis 907 . A control circuit (not shown) is provided for receiving the photocurrents from each of the photodetectors and for generating the control signal for provision to the actuators. Thus, in use, the actuators automatically orient the canopy 70 with respect to the table 908 in accordance with predetermined criteria set forth within the control circuit. The canopy 70 provides shade within a shaded area between shadow lines 901 and 902 . Preferably, the shaded area varies its position with respect to the canopy as the orientation of the table with respect to the sun is varied thus providing shade to the table at a similar location as the orientation of the table to the sun changes. Referring to FIG. 10 , a further embodiment of the invention is shown. In this embodiment a stroller 1002 is provided with a canopy 1001 pivotally mounted to a frame portion 1009 of the stroller about pivot points 1005 and 1006 . The canopy 1001 exhibits actuated movement with respect to the stroller 1002 between first and second positions 1003 and 1004 , respectively. Photodetectors 1007 and 1008 are disposed on at least one of a frame portion of the stroller and on the canopy to detect light and to generate photocurrent in response thereto. A control circuit (such as the one illustrated in FIG. 4 ) is used to receive this photocurrent and to provide a control signal for actuating movement of the canopy. For powering of the control circuit an optional generator 1010 is installed with its stator coupled to the frame portion 1009 and its armature coupled to a wheel on the stroller. Thus, movement of the stroller results in rotation of the arniature, which in turn provides electrical energy to the control circuit. Optionally, an energy storage device 1014 in the form of a battery is provided for storing energy and for powering of the control circuit and actuator when the stroller is stationary. Further optionally, an electrical port 1012 having a predetermined configuration consistent with an interface for a portable electronic device is provided. For instance, the electrical port 1012 receives power from the energy storage device 1014 . Referring to FIG. 11 , a further embodiment of the invention is shown. In accordance with this embodiment, a variation of the dual axis pivot mechanism is shown for a solar umbrella for use with a table 1108 . In this case a dual axis pivot component is provided between a fixed portion 1103 and an umbrella shaft 1105 . The fixed portion 1103 is mounted to the table 1108 . The dual axis pivot component has an intermediate component 1104 , thus the umbrella shaft 1105 is pivotally mounted to the intermediate component 1104 , for pivoting about a first axis 1106 with respect to the intermediate component 1104 , and the intermediate component 1104 is pivotally mounted to the fixed portion 1103 for pivoting about a second axis 1107 with respect to the fixed portion 1103 . Preferably, the first and the second axes 1106 and 1107 are orthogonal. At an end of the umbrella shaft 1105 , other than the end that is pivotally mounted to the intermediate component 1104 , a canopy 70 is disposed. The umbrella shaft 1105 preferably includes a mechanism for allowing movement of the canopy 70 between an open position and a closed position. Two actuators (not shown) are provided for pivoting of the canopy 70 about the first axis 1106 and the second axis 1107 in response to photocurrents generated by photodetectors 78 and 59 , and photodetectors 58 and 79 (occluded in FIG. 11 ). Alternatively, the canopy includes a switch actuated by opening and closing of the canopy. Thus in a first open position the switch is actuated and electrical energy from a power source is provided to the control circuit. In a second closed position electrical energy from the power source is other than provided to the control circuit. Alternatively, a rain sensor 1112 , and a rain detection circuit 1114 , is provided for detecting whether the upper surface of the canopy is subjected to rain. If a determination is made that rain is present then the rain sensor provides a rain signal to the control circuit. The control circuit in response to the rain signal provides control signals for moving the canopy to a covering position. For an umbrella type canopy, this is an upright position for the support shaft. Of course, the optical sensors need not be disposed on the umbrella canopy. Optionally they are disposed on other than the canopy of the umbrella in such an orientation that they detect one of shade within the shaded area formed by the canopy and an angle of light impacting the canopy. Thus, moving of the canopy need not result in motion of the photodetectors. Advantageously, by providing an automated system for positioning of the canopy with respect to an object, manually orienting of the canopy is for the most part obviated. Preferably, the control circuit is powered by solar power or stroller motion, obviating the need for extension cords and batteries. Further, this results in an environmentally friendly automated canopy positioning system. Alternatively, the positioning system is powered by a portable power source in the form of a battery. Further alternatively, the positioning system is powered by a power grid. Numerous other embodiments may be envisaged without departing from the spirit or scope of the invention.

1a

TECHNICAL FIELD The invention relates to a dishwashing machine, in particular a commercial dishwashing machine, and to a method for the operation thereof. BACKGROUND Dishwashing machines (warewashers), in particular commercial dishwashing machines, in the form of box-type dishwashing machines (box-type warewashers) may be hood-type dishwashing machines (hood-type warewashers) or frontloaders (frontloader warewashers). A dishwashing machine (box-type warewasher) and a plurality of methods for the operation thereof are known, for example, from WO 2006/129963 A2. Said dishwashing machine is provided with a steam generator for treating the washware with steam during various process cycles. The use of steam is provided before a washing cycle or after a washing cycle. Treating washware with steam between a prewash cycle and a main wash cycle is also known from DE 29 00 954 A1. EP 0 808 894 B1 discloses a method according to which the washware is sprayed with detergent solution (detergent) during a prewash cycle, before a main wash cycle and, following this, a final rinse cycle then take place. Spraying washware with a highly concentrated alkaline detergent solution is also known from EP 1 347 039 B1. WO 2006/037447 A1 discloses a dishwashing machine in which washware is washed with washing liquid, then rinsed with fresh water, and then subjected to thermal aftertreatment with steam. Since washware normally includes not only tableware, for example plates and cups, but also cutlery, for example spoons, forks and knives, and also other utensils, for example trays, pots and pans, dishwashing machines, in particular commercial dishwashing machines, are also called utensil washers (warewashers). Commercial dishwashing machines or utensil washers normally operate in two main process steps: a 1st step which includes washing with a washing liquid, and a 2nd step which includes final rinsing with heated fresh water and the metered addition of a final rinse aid. In order to be able to carry out these process steps, a commercial dishwashing machine is generally equipped with two independent liquid systems which are completely separate from one another. One of the liquid systems is a washing water circuit which is responsible for washing the washware, with washing being carried out using recirculated water from a washing tank. The other liquid system is a fresh water system which is responsible for final rinsing. Final rinsing is carried out with fresh water, preferably with fresh water from a water heater (boiler). The fresh water is likewise held by the washing tank after being sprayed. The main objective of final rinsing is to remove washing liquor from the washware. In addition, the final rinse water which flows into the washing tank during the final rinse step serves to regenerate the washing water which is present in the washing tank. Before fresh water is sprayed and thus conducted into the washing tank as final rinse liquid as a result of final rinsing, a quantity of washing liquid which is equal to the quantity of fresh water is pumped out of the washing tank. Modern dishwashing machines are equipped with a plurality of programs. These programs differ mainly by virtue of program run times of the washing process step of different lengths. The customer has the option of selecting a short washing program for washware which is lightly soiled, or of selecting a correspondingly longer washing program for washware which is heavily soiled. The proportion of washware which is heavily soiled, for example contains burnt-on food residues, is frequently very high, particularly in the case of commercial dishwashing machines or utensil washers. Since cookware, heat-retaining boxes or baking tins and baking trays with burnt-on food residues, for example, are washed in dishwashing machines of this type, such washware is prewashed or postwashed in many cases since “normal” machine washing is not able to provide a satisfactory wash result, even with relatively long run times of the programs. The object of the invention is to provide an option by means of which the wash process can be shortened in an ergonomical and environmentally friendly manner. SUMMARY The invention accordingly relates to a dishwashing machine or utensil washer which is in the form of a box-type dishwashing machine and is designed to carry out the following method steps: step 1: carrying out a pretreatment cycle comprising spraying the washware with an alkaline, highly concentrated detergent solution whose pH is at least 1 higher than the pH of the washing liquid of a main washing cycle; following step 1, step 2: carrying out an action cycle over an action time period during which the detergent solution acts on the washware and the washware is additionally thermally pretreated with steam, with the thermal pretreatment of the washware being carried out over at least a portion of the action time period, preferably over the entire action time period; following step 2, step 3: carrying out a main washing cycle comprising spraying the washware with washing liquid which contains water and detergent; following step 3, step 4: carrying out a final rinse cycle during which the washware is sprayed with final rinse liquid. By virtue of the invention, two process steps in which steam is used in combination with a highly concentrated alkaline detergent solution to remove dirt which is located on the washware, in particular dirt in the form of food residues or other foodstuff residues, precede the washing cycle. The highly concentrated, alkaline detergent solution is sprayed onto the washware which is located in the treatment chamber of the dishwashing machine or the utensil washer. During the following action cycle, an action time period is integrated in the program sequence during which the highly concentrated, alkaline detergent solution can act on the washware and during which steam is additionally introduced into the treatment chamber, for example into the region of the washware and there sprayed onto the washware. On account of the combination of the simultaneous action of highly concentrated, alkaline detergent and simultaneous thermal treatment of the washware with steam, the molecular structures of the dirt (food residues, foodstuff residues etc.) on the washware is broken down, with the dirt becoming detached from the washware. Following the abovementioned pretreatment with highly concentrated, alkaline detergent solution and simultaneous thermal treatment with steam, the main wash step is executed, which step can proceed in a conventional manner. The main wash step can be assisted by hot steam which is introduced into the treatment chamber during the main wash step, in order to promote the washing efficiency. On account of the uniform distribution of steam, steam has an advantage over a conventional washing cycle, predominantly in shadow zones of the washware. Steam reaches every surface of the washware within the treatment chamber equally, irrespective of the position and the orientation of the washware, for example of the plates, cups, trays, pans and pots. BRIEF DESCRIPTION OF THE DRAWINGS The invention is described below with reference to the associated drawings on the basis of preferred embodiments of the invention as examples. In the drawings FIG. 1 schematically shows a dishwashing machine according to the invention, FIG. 2 schematically shows a further embodiment of a dishwashing machine according to the invention, FIG. 3 schematically shows a further embodiment of a dishwashing machine according to the invention, FIG. 4 schematically shows a further embodiment of a dishwashing machine according to the invention, FIG. 5 schematically shows a further embodiment of a dishwashing machine according to the invention, and FIG. 6 schematically shows a further embodiment of a dishwashing machine according to the invention. DETAILED DESCRIPTION FIGS. 1 to 6 show six different embodiments of dishwashing machines 100 , 200 , 300 , 400 , 500 and 600 according to the invention. The invention relates to dishwashing machines, in particular commercial dishwashing machines, which can also be called utensil washers (warewashers), in the form of a box-type dishwasher. Said dishwashing machines contain a program-control device 2 for controlling at least one wash program and a treatment chamber 4 , which can be closed by a door (not shown) or a hood (not shown), in a machine housing 6 for accommodating washware (not shown) to be washed, for example tableware, cutlery, pots, pans and trays. A washing tank 8 for holding sprayed liquid from the treatment chamber 4 is located beneath the treatment chamber 4 . A washing pump 10 is provided for conveying washing liquid from the washing tank 8 , through a washing liquid line system 12 , to washing nozzles 14 and 16 which, in the treatment chamber 4 , are directed at the region of the washware to be washed and spray the washing liquid onto the washware to be washed. The sprayed washing liquid falls back into the washing tank 8 due to the force of gravity. As a result, the washing tank 8 , the washing pump 10 , the washing liquid line system 12 , the washing nozzles 14 and 16 , together with the wash chamber 4 , form a washing liquid circuit. The washing liquid line system 12 connects the pressure side of the washing pump 10 to the washing nozzles 14 and 16 . Furthermore, a final rinse apparatus 18 is provided for conveying final rinse liquid by means of a final rinse pump 20 , through a final rinse liquid line system 22 , to final rinse nozzles 24 and 26 which, in the treatment chamber 4 , are directed at the region of the washware to be washed. The sprayed final rinse liquid falls from the treatment chamber 4 into the washing tank 8 due to the force of gravity. The final rinse liquid line system 22 connects the pressure side of the final rinse pump 20 to the final rinse nozzles 24 and 26 . The washing nozzles 14 and 16 and the final rinse nozzles 24 and 26 can be arranged in the regions above and/or below and possibly also to the side of the region of the washware and can in each case be directed toward the region in which the washware is positioned. A large number of washing nozzles 14 is preferably provided on at least one upper washing arm 15 , a large number of washing nozzles 16 is preferably provided on at least one lower washing arm 17 , a large number of final rinse nozzles 24 is preferably provided on at least one upper final rinse arm 25 and a large number of final rinse nozzles 26 is preferably provided on at least one lower final rinse arm 27 . Before the final rinse liquid is sprayed, a quantity of washing liquid which corresponds to the final rinse liquid is in each case pumped out of the washing tank 8 by means of a discharge pump 30 whose suction side is connected to a sump 32 of the washing tank 8 . If the washing tank 8 is empty before the dishwashing machine is first started, it first has to be filled with fresh water via a fresh water line (not shown) or with fresh water or with another final rinse liquid by means of the final rinse apparatus 18 and its final rinse pump 20 . The final rinse liquid may be fresh water or fresh water mixed with final rinse aid. The washing liquid contains detergent which is automatically added in a metered manner to the liquid which is contained in the washing tank 8 by a detergent metering apparatus (not shown). All the dishwashing machines of the invention contain a steam apparatus with a steam generator for generating steam and introducing steam into the treatment chamber, in order to subject the washware to the action of steam in said treatment chamber. The steam apparatus can be implemented in various embodiments. Examples are illustrated in FIGS. 1 to 6 . The differences between the various embodiments 100 to 600 which are illustrated in FIGS. 1 to 6 are described below. In the dishwashing machines 100 , 200 and 300 of FIGS. 1, 2 and 3 , the suction side of the final rinse pump 20 can be connected to a fresh water connection 36 via a return-prevention means 34 . The return-prevention means 34 (air gap) prevents liquid returning from the final rinse liquid line system 22 to the public water supply system via the fresh water connection 36 . A water heater 35 can be located between the return-prevention means 34 and the suction side of the final rinse pump 20 . The dishwashing machines 100 , 200 and 300 of FIGS. 1, 2 and 3 are provided with a steam apparatus 38 which contains a steam generator 40 whose steam side 41 is connected to the treatment chamber 4 via a steam line 42 and whose water side can be connected to a fresh water connection 36 , for example via a non-return valve 37 . The downstream end 44 of the steam line 42 ends, for example, in a side wall of the treatment chamber 4 . The steam generator 40 can also be integrated in the dishwashing machine in such a way that its steam outlet 41 issues directly into the treatment chamber 4 , without the steam line 42 . By way of example, the steam generator 40 can be arranged beneath the treatment chamber 4 . In the dishwashing machines 400 , 500 and 600 of FIGS. 4, 5 and 6 , a combined water heater and steam apparatus 48 is provided instead of the steam apparatus 38 . The water heater and steam apparatus 48 contains a steam generator 50 . The steam generator 50 can be connected to a fresh water connection 36 and has a steam outlet 51 which, for example via a steam line 52 , issues into the treatment chamber 4 , for example by means of a steam outlet opening 54 in a side wall of the treatment chamber 4 . Furthermore, the steam generator 50 has a final rinse liquid outlet 55 which is connected to the suction side of the final rinse pump 20 for the purpose of conveying final rinse liquid through the final rinse liquid line system 22 to the final rinse nozzles 24 and 26 . The steam generator 50 contains a heating system 56 . Steam or heated final rinse liquid can be produced by said heating system. The program-control device 2 of the dishwashing machines 100 , 200 , 300 , 400 , 500 and 600 of FIGS. 1 to 6 contains at least one wash program which is designed to carry out the following program steps: step 1: carrying out a pretreatment cycle comprising spraying the washware with an alkaline, highly concentrated detergent solution whose pH is at least 1 higher than the pH of the washing liquid of a main washing cycle; following step 1, step 2: carrying out an action cycle over an action time period during which the detergent solution acts on the washware and the washware is additionally thermally pretreated with steam, with the thermal pretreatment of the washware being carried out over at least a portion of the action time period, preferably over the entire action time period; following step 2, step 3: carrying out a main washing cycle comprising spraying the washware with washing liquid which contains water and detergent; following step 3, step 4: carrying out a final rinse cycle during which the washware is sprayed with final rinse liquid. Spraying of the washware with the alkaline, highly concentrated detergent solution whose pH is at least 1 higher than the pH of the washing liquid of the main washing cycle can be performed in various ways. According to one preferred embodiment of the invention, a supply and spray system is provided, by means of which the alkaline, highly concentrated detergent solution whose pH is at least 1 higher than the pH of the washing liquid of a main washing cycle can be conveyed out of a detergent solution container and sprayed onto the washware in the treatment chamber 4 . In the dishwashing machines 100 and 400 of FIGS. 1 and 4 , a supply and spray system 110 is provided for the alkaline, highly concentrated detergent solution, which system comprises a supply apparatus 112 and a spray apparatus 114 . The supply apparatus 112 contains a detergent solution pump 60 with a suction side 61 and a pressure side 62 . A suction line 64 for conveying alkaline, highly concentrated detergent solution 66 from a detergent solution container 68 is connected to the suction side 61 . The spray apparatus 114 comprises a detergent solution line system 70 which is connected to the pressure side 62 of the detergent solution pump 60 , and detergent solution nozzles, for example detergent solution nozzles 74 , which are connected to said detergent solution line system and are formed in a detergent solution arm 75 which is preferably arranged above the region of the washware of the wash chamber 4 , and/or detergent solution nozzles 76 which are formed in a detergent solution arm 77 which is preferably arranged below the region of the washware of the detergent chamber 4 . The washing machines 200 and 400 of FIGS. 2 and 4 again have the supply apparatus 112 for the alkaline, highly concentrated detergent solution, but a separate spray apparatus 114 is not provided here and instead the pressure side 62 of the detergent solution pump 60 is connected to the final rinse liquid line system 22 via a connection line 78 . As a result, final rinse liquid or the alkaline, highly concentrated detergent solution 66 can be alternately sprayed onto the washware via the final rinse nozzles 24 , 26 . The supply and spray system 120 for the highly concentrated detergent solution of these dishwashing machines 200 and 400 therefore comprises the supply apparatus 112 and the final rinse liquid line system 22 and also the final rinse nozzles 24 and 26 . In the dishwashing machines 300 and 600 of FIGS. 3 and 6 , a supply and spray system 130 is provided for the alkaline, highly concentrated detergent solution, which system again contains the supply apparatus 112 but not the spray system 114 . The spray system used is the washing liquid spray system, since the pressure side 62 of the detergent solution pump 60 is connected to the washing liquid line system 12 via a connection line 78 . As a result, washing liquid or the alkaline, highly concentrated detergent solution 66 can be alternately sprayed by means of the washing nozzles 14 and 16 . The program-control device 2 controls the washing pump 10 , the final rinse pump 20 , the outflow pump 30 and the detergent solution pump 60 as a function of the wash program respectively selected on the program-control device 2 by an operator. At least one wash program is provided; a plurality of optionally selectable wash programs is preferably provided. According to the invention, the at least one wash program can be designed in such a way that the introduction of steam into the treatment chamber for the thermal pretreatment of the washware according to step 2 is started as early as after the beginning but before the end of step 1, preferably during the last quarter of the duration of step 1. Furthermore, the at least one wash program can be designed in such a way that the washware is sprayed with an alkaline, highly concentrated detergent solution according to step 1 over a time period in the range of between 5 seconds and 30 seconds, preferably between 10 seconds and 20 seconds. According to a further embodiment of the invention, the detergent program can be designed in such a way that steam thermally acts on the washware during said step 2 over a time period in the range of between 0.5 minutes and 7 minutes, preferably in a range of between 1 minute and 4 minutes. In order to shorten the wash time period, it may also be advantageous for steam to also be introduced into the wash chamber and the washware to be subjected to the action of the steam at least over a portion of the time period during which the washware is sprayed with washing liquid according to step 3. It is particularly advantageous if, according to the invention, the wash program involves washing liquid which contains detergent and has a pH in a range of between 9.0 and 11, preferably between 9.5 and 10.5, being used as the washing liquid for carrying out the main washing cycle according to step 3. Furthermore, provision may advantageously be made in the wash program for the pH of the alkaline, highly concentrated detergent solution for spraying the dishes according to step 1 to be at least 11. Furthermore, the at least one wash program for washing washware which is heavily soiled and/or contains firmly adhering dirt may involve a prewash step during which the washware is sprayed with liquid, preferably washing liquid containing detergent, being carried out before the dishes are sprayed with an alkaline, highly concentrated detergent solution according to step 1.

1a

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] The present invention relates to an endoscope, and in particular, to an endoscope having an insertion unit that is inserted into deep digestive tracts such as a small intestine and a large intestine to be observed. [0003] 2. Description of the Related Art [0004] When an insertion unit of an endoscope is inserted in deep digestive tracts, such as a small intestine, since a force is not easily transmitted to a tip of the insertion unit by merely pushing the insertion unit because of complicated bending of an intestinal tract, it is hard to perform insertion into the depth. For example, when excessive bending or flexion arises in the insertion unit, it becomes impossible to further insert the insertion unit into the depth. Then, a method is proposed, which prevents excessive bending or flexion of an insertion unit by putting an insertion aid on the insertion unit of the endoscope and inserting the insertion unit into a body cavity, and guiding the insertion unit by this insertion aid. [0005] Japanese Patent Application Laid-Open No. 2005-334475 discloses an endoscope apparatus which not only provides a first balloon in a tip portion of an insertion unit of an endoscope, but also provides a second balloon in a tip portion of an insertion aid (this is also called an over tube or a sliding tube). It is possible to make the insertion unit and insertion aid fix in an intestinal tract, such as a small intestine, by having the first balloon and second balloon expanded. Hence, by inserting the insertion unit and insertion aid by turns with repeating expansion and shrinkage of the first balloon and second balloon, it is possible to insert the insertion unit into the depth of a complicatedly bending intestinal tract, such as a small intestine. SUMMARY OF THE INVENTION [0006] By the way, in recent years, there has been a request of modifying a mounting location of a balloon, which is mounted on an insertion unit of an endoscope, according to an application. For example, when performing a bending operation of a bend of an insertion unit after expanding the balloon, it is desired to mount the balloon in a base end side further than in the bend. In addition, when it is desired to enlarge a stroke of the insertion operation mentioned above, or when it is desired to obtain a blurless observation image after expansion of a balloon, it is desired to mount the balloon near a tip of an insertion unit. [0007] Nevertheless, in the endoscope disclosed in Japanese Patent Application Laid-Open No. 2005-334475, since an opening of an air supply passage to supply and suck air to/from the balloon on an outer peripheral surface of a tip portion of the insertion unit, it is only possible to mount the balloon in the vicinity of this opening. [0008] A method in which a tube is post-installed, the tube being an air supply passage in an outside of an insertion unit is conceivable as a method of mounting a balloon in an arbitrary location. However, in this case, since a tip of the tube must be arranged inside the balloon, there arise problems of becoming difficult to fix the balloon, and being hard to keep airtightness after fixing the balloon. [0009] The present invention was made in view of such a situation, and aims at providing an endoscope which can easily fix a balloon and keep airtightness after the fixation, and can raise a degree of freedom of a mounting location of the balloon. [0010] In order to attain the above-mentioned object, an invention according to a first aspect is an endoscope apparatus which includes an insertion unit which is inserted into a body, and a pipeline which is provided inside the insertion unit, and supplies a fluid to a balloon which is mounted on an outer peripheral surface of the insertion unit, characterized in that the pipeline is made to have openings in a plurality of locations in an axial direction of the insertion unit on the outer peripheral surface of the insertion unit. [0011] According to the invention described in the first aspect, since the pipeline is made to have openings in a plurality of locations in an axial direction of the insertion unit, it is possible to select an opening from the plurality of openings and to mount a balloon. That is, according to the invention described in the first aspect, it is possible to select a mounting position of a balloon in the axial direction of the insertion unit from two or more locations. In addition, according to the invention of the first aspect, since the pipeline is provided inside the insertion unit, it is possible to easily mount a balloon, and to keep securely airtightness between an outer peripheral surface of the insertion unit and an inner peripheral surface of the balloon. [0012] An invention according to a second aspect is characterized in that each sealing device is mounted detachably in the plurality of openings in the invention according to the first aspect. As the each sealing device according to the second aspect, for example, there is a rubber ring which is fit outside on the insertion unit, a rubber plug pressed fit into the opening, a plug member fit to or screwed into the opening, an end of the balloon fixed in a location of the opening, or a valve member arranged in the pipeline. [0013] An invention described in a third aspect is characterized in that at least one opening among the plurality of openings is provided in a fixed location of a balloon which is mounted so as to be made to communicate with another opening, in the invention according to the first or second aspects. According to the invention according to the third aspect, it is possible to seal the opening by a balloon which is mounted on another opening. [0014] An invention according to a fourth aspect is characterized in that the opening is provided in a concave groove formed in an outer periphery of the insertion unit over a round, in the invention according to any one of the first to third aspects. According to the invention according to the fourth aspect, since the opening is provided in the concave groove, it is possible to arrange a rubber ring, which seals the opening, inside the concave groove, and hence, it is possible to prevent the rubber ring from projecting from an outer peripheral surface of the insertion unit. In addition, according to the invention according to the fourth aspect, since the opening is provided in the concave groove, it becomes hard for the opening to be sealed by the balloon when a fluid is sucked from the opening, and hence, it is possible to shrink the balloon securely. [0015] An invention according to a fifth aspect is characterized in that the plurality of openings is provided in a tip side and a base end side of a bend respectively, which is formed in the insertion unit and is given a bending operation, in the invention according to any one of the first to fourth aspects. [0016] According to the present invention, since a plurality of openings is provided in an axial direction of the insertion unit, it is possible to mount a balloon in two or more locations in the axial direction of the insertion unit. In addition, according to the present invention, since a pipeline is provided inside an insertion unit, it is possible to easily mount a balloon, and to keep securely airtightness between an outer peripheral surface of the insertion unit and an inner peripheral surface of the balloon. BRIEF DESCRIPTION OF THE DRAWINGS [0017] FIG. 1 is a system block diagram of an endoscope apparatus to which an endoscope which relates to the present invention is applied; [0018] FIG. 2 is a perspective view showing a tip portion of an insertion unit; [0019] FIG. 3 is a pipeline diagram showing a pipeline in the insertion unit schematically; [0020] FIG. 4 is a pipeline diagram of the insertion unit where an opening in a tip side is selected and a balloon is mounted; [0021] FIG. 5 is a pipeline diagram of the insertion unit where an opening in a base end side is selected and a balloon is mounted; [0022] FIG. 6 is a pipeline diagram of the insertion unit where two opening are provided in a connection ring; [0023] FIG. 7 is a pipeline diagram of the insertion unit where a mounting location of a balloon is different from that in FIG. 6 ; and [0024] FIG. 8 is a pipeline diagram of the insertion unit where a mounting location of a balloon is different from that in FIG. 6 . DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0025] Preferable embodiments of an endoscope according to the present invention will be described in detail with reference to accompanying drawings. [0026] FIG. 1 is a system block diagram showing an example of an endoscope apparatus to which the endoscope which relates to the present invention is applied. As shown in FIG. 1 , an endoscope apparatus mainly includes an endoscope 10 and a balloon controller 100 . [0027] The endoscope 10 includes a hand operation unit 14 and an insertion unit 12 which is installed in connection with this hand operation unit 14 and is inserted inside a living body. A universal cable 16 is connected to the hand operation unit 14 , and an LG connector 18 is provided at a tip of this universal cable 16 . The LG connector 18 is detachably connected to a light source apparatus 20 , and thereby illumination light is transmitted to an illumination light optical system (not shown) provided at a tip of the insertion unit 12 . In addition, an electric connector 24 is connected to the LG connector 18 through a cable 22 , and this electric connector 24 is detachably connected to a processor 26 . [0028] In the hand operation unit 14 , an air supply/water supply button 28 , a suction button 30 , a shutter release 32 , and a function switching button 34 are juxtaposed, while a pair of angle knobs 36 and 36 are provided. A balloon air supply opening 38 is formed by an L-shaped bent pipe in a base end portion of the hand operation unit 14 . A below-mentioned balloon 60 can be expanded or shrunk by supplying or sucking a fluid, such as air, to/from this balloon air supply opening 38 . [0029] The insertion unit 12 includes an elastic portion 40 , a bending portion 42 , and a tip portion 44 sequentially from a hand operation unit 14 side. The elastic portion 40 is a portion which has sufficient flexibility, and is installed in connection with a base end side of the bending portion 42 . [0030] The bending portion 42 is constructed so as to be bent remotely by rotating the angle knobs 36 and 36 of the hand operation unit 14 . For example, the bending portion 42 is constructed so that the bending portion 42 may be given a bending operation by a plurality of cylindrical joint rings being coupled rotatably by a guide pin, a plurality of operation wires being made to be inserted inside the joint rings and being guided by the guide pin, and the operation wires being pushed and pulled. It is possible to orient the tip portion 44 in a desired direction by giving the bending operation to this bending portion 42 . [0031] The tip portion 44 is a hard portion provided at a tip of the insertion unit 12 , and as shown in FIG. 2 , an observation optical system 52 , illumination light optical systems 54 and 54 , an air supply/water supply nozzle 56 , and a forceps opening 58 are provided in its tip surface 45 . A CCD (not shown) is arranged behind the observation optical system 52 , and a signal cable (not shown) is connected to a substrate which supports that CCD. The signal cable is inserted into the insertion unit 12 , the hand operation unit 14 , a universal cable 16 , and the like, and is extended to an electric connector 24 to be connected to a processor 26 . Therefore, an observation image taken in by the observation optical system 52 is imaged on a light-receiving surface of the CCD to be converted into an electric signal, and this electric signal is output to the processor 26 in FIG. 1 through the signal cable to be converted into a video signal. Thereby, the observation image is displayed on a monitor 50 connected to the processor 26 . [0032] An emission end of a light guide (not shown) is arranged behind the illumination light optical systems 54 and 54 in FIG. 2 , the light guide is inserted into the insertion unit 12 , hand operation unit 14 , and universal cable 16 in FIG. 1 , and its incident end is arranged inside the LG connector 18 . Hence, by connecting the LG connector 18 to the light source apparatus 20 , illumination light radiated from the light source apparatus 20 is transmitted to the illumination light optical systems 54 and 54 in FIG. 2 through the light guide, and is radiated forward from the illumination light optical systems 54 and 54 . [0033] The air supply/water supply nozzle 56 communicates with a valve (not shown) operated with the air supply/water supply button 28 in FIG. 1 , and this valve communicates with an air supply/water supply connector 48 provided in the LG connector 18 . An air supply/water supply device not shown is connected to the air supply/water supply connector 48 , and air and water are supplied. Hence, it is possible to inject air or water from the air supply/water supply nozzle 56 to the observation optical system by operating the air supply/water supply button 28 . [0034] The forceps opening 58 in FIG. 2 communicates with a forceps insertion portion 46 in FIG. 1 . Therefore, it is possible to draw a treatment tool from the forceps opening 58 by inserting the treatment tool, such as a forceps, from the forceps insertion portion 46 . In addition, the forceps opening 58 communicates with a valve operated with the suction button 30 , and this valve is connected to a suction connector 49 of the LG connector 18 . Hence, it is possible to suck a pathological change portion or the like from the forceps opening 58 by connecting a not-shown suction device to the suction connector 49 , and manipulating the valve with the suction button 30 . [0035] FIG. 3 is a diagram showing a pipeline in the insertion unit 12 schematically. As shown in this diagram, a pipeline 66 is provided inside the insertion unit 12 , this pipeline 66 is branched on the way, and two openings are provided in an outer peripheral surface of the insertion unit 12 . That is, two openings 64 and 65 are provided in the outer peripheral surface of the insertion unit 12 . [0036] The opening 64 is provided in a concave groove 67 formed in a base end portion of the tip portion 44 . The concave groove 67 is formed in an outer peripheral surface of the tip portion 44 over a round, and is formed in width of a rubber ring 69 shown in FIG. 5 . Hence, when the rubber ring 69 is fit outside the concave groove 67 , the rubber ring 69 is housed inside the concave groove 67 . [0037] The opening 65 is provided in a concave groove 68 formed in a base end portion of a connection ring 41 which connects the bending portion 42 and/with the elastic portion 40 . The concave groove 68 is formed in an outer peripheral surface of the connection ring 41 over a round, and is formed in the same width as the above-mentioned concave groove 67 , that is, in the width of the rubber ring 69 shown in FIG. 4 . Hence, when the rubber ring 69 is fit outside the concave groove 68 , the rubber ring 69 is contained inside the concave groove 68 . [0038] The rubber ring 69 is formed in a ring shape of an elasticity material such as rubber, and its inner diameter before outside fitting is formed a little smaller than outer diameters in locations of the concave grooves 67 and 68 . Hence, by making the rubber ring 69 fit outside the concave groove 67 or 68 , the rubber ring 69 sticks to a peripheral surface of the concave groove 67 or 68 by its own elastic force, and the opening 64 or 65 is sealed. In addition, although it is made to make the common rubber ring 69 fit outside the concave grooves 67 and 68 in this embodiment, it is not limited to this, but different rubber rings may be made to fit outside. [0039] As shown in FIG. 4 or 5 , the balloon 60 is mounted in a location of the opening 64 or 65 . The balloon 60 is formed of an elastic material, such as rubber, in substantially cylindrical shape whose end portion is shrunk, and includes a tip portion 60 A and a base end portion 60 B with a smaller diameter, and a swelling portion 60 C which is a central portion. After inserting the insertion unit 12 and arranging it in a predetermined location of the insertion unit 12 , this balloon 60 is fixed to the insertion unit 12 by putting rings 61 and 62 (referring to FIG. 2 ), made of rubber, in the tip portion 60 A and base end portion 60 B. In addition, a fixing method of the tip portion 60 A and base end portion 60 B is not limited particularly, it is also sufficient to wind a string to fix them. In addition, the balloon 60 is constructed expandably, and it is made to be substantially spherical when it expands, and it sticks to an outer surface of the insertion unit 12 when it shrinks. [0040] The above-mentioned pipeline 66 in FIG. 3 includes a tube, a pipe, a hole, and the like, and a base end side (left side in FIG. 3 ) of the pipeline 66 communicates with the balloon air supply opening 38 of the hand operation unit 14 in FIG. 1 . The below-mentioned balloon controller 100 is connected to the balloon air supply opening 38 through a tube 110 . Therefore, it is possible to supply and suck a fluid to/from the openings 64 and 65 by supplying and sucking a fluid, such as air, from the balloon controller 100 . [0041] The balloon controller 100 is an apparatus which not only supplies and sucks a fluid to the balloon 60 (refer to FIGS. 4 and 5 ) to expand and shrink the balloon 60 , but also controls internal pressure of the balloon 60 at that time, and is mainly constructed by an apparatus main body 102 and a hand switch 104 for remote control. [0042] A power switch SW 1 , a stop switch SW 2 , and a pressure display unit 106 are provided in a front face of the apparatus main body 102 . The pressure display unit 106 is a panel which displays a pressure value of the balloon 60 , and displays an error code at the time of occurrence of an abnormality such as a burst of a balloon. [0043] The tube 110 which performs air supply and suction to/from the balloon 60 is connected to the front face of the apparatus main body 102 . A backflow preventing unit 112 for preventing a backflow of humors when the balloon 60 is burst is provided in a junction between the tube 110 and apparatus main body 102 . The backflow preventing unit 112 is constructed by incorporating a filter for gas-liquid separation into an inside of a hollow disk-like case (not shown) which is mounted detachably in the apparatus main body 102 , and prevents a liquid with the filter from flowing into the apparatus main body 102 . [0044] On the other hand, various kinds of switches are provided in the hand switch 104 . For example, a stop switch which is the same as the stop switch SW 2 of the apparatus main body 102 side, an ON/OFF switch which indicates pressurization or depressurization of the balloon 60 , a pause switch for holding pressure of the balloon 60 , and the like are provided. This hand switch 104 is electrically connected to the apparatus main body 102 through a cord 130 . In addition, although not shown in FIG. 1 , a display unit which shows an air supply state or an exhaust state of the balloon 60 is provided in the hand switch 104 . [0045] The balloon controller 100 constructed as described above not only supplies air to the balloon 60 to expand it, but also to control the air pressure to a constant value to keep the balloon 60 in an expanding state. In addition, the balloon controller 100 not only sucks air from the balloon 60 to shrink it, but also to control the air pressure to a steady value to keep the balloon 60 in a shrinking state. [0046] The balloon controller 100 is connected to a balloon-dedicated monitor 82 , and makes a pressure value, and expansion and shrinkage states of the balloon 60 displayed on the balloon-dedicated monitor 82 when expanding and shrinking the balloon 60 . In addition, the pressure value, and expansion and shrinkage states of the balloon 60 may be superimposed on an observation image of the endoscope 10 to be displayed on the monitor 50 . [0047] As an example of an operation method of the endoscope apparatus constructed as described above, the insertion unit 12 is inserted in a push mode, and a balloon 60 is expanded if necessary, and is fixed inside a living body (for example, large intestine). Then, after drawing the insertion unit 12 to simplify a pipe shape of the living body (for example, large intestine), the balloon 60 is shrunk and the insertion unit 12 is further inserted in the depth of an intestinal tract. For example, the insertion unit 12 is inserted from an anus of a subject, the insertion unit 12 is fixed to the intestinal tract by the balloon 60 being expanded when the tip of the insertion unit 12 passes over a sigmoid colon, and the insertion unit 12 is pulled for the sigmoid colon to be made substantially linear. Then, the balloon 60 is shrunk and the tip of the insertion unit 12 is being inserted in the depth of the intestinal tract. Thereby, it is possible to insert the insertion unit 12 into the depth of the intestinal tract. [0048] Next, an operation of the endoscope 10 constructed as described above will be explained. [0049] The endoscope 10 includes two openings 64 and 65 in the insertion unit 12 , and a surgeon selects one of the two openings 64 and 65 to mount the balloon 60 according to an application. FIGS. 2 and 4 show examples of the balloon 60 being mounted in location of the opening 64 , and FIG. 5 shows an example of the balloon 60 being mounted in a location of the opening 65 . [0050] As shown in FIGS. 2 and 4 , when the balloon 60 is mounted in the location of the opening 64 , the tip portion 60 A of the balloon 60 is fixed on an outer peripheral surface of the tip portion 44 which is nearer to the tip than the opening 64 , and the base end portion 60 B of the balloon 60 is fixed on an outer peripheral surface of the bending portion 42 . Thereby, since the opening 64 is arranged inside the swelling portion 60 C of the balloon 60 , it is possible to expand and shrink the balloon 60 by supplying and sucking a fluid, such as air, to/from the opening 64 . [0051] In this case, the rubber ring 69 is made to fit outside the concave groove 68 , and the opening 65 which is not selected is sealed with the rubber ring 69 . Thereby, when a fluid is supplied and sucked by the balloon controller 100 , the fluid is supplied and sucked to/from the opening 64 . [0052] When the balloon 60 is mounted in the location of the opening 64 as described above, the balloon 60 is mounted near the tip of the insertion unit 12 . Hence, since the observation optical system 52 of the tip portion 44 is fixed to the inside of the living body when the balloon 60 is expanded and the insertion unit 12 is fixed to the inside of the living body (large intestine or the like), it is possible to obtain an observation image with a small blur. In addition, since the balloon 60 is near the tip of the insertion unit 12 , the insertion unit 12 can be fixed to the further depth of the living body when the balloon 60 is expanded and fixed to the inside of the living body. Hence, it is possible to enlarge a stroke in one insertion operation. [0053] As shown in FIG. 5 , when mounting the balloon 60 in a location of the opening 65 , the tip portion 60 A of the balloon 60 is fixed on an outer peripheral surface of the connection ring 41 which is nearer to the tip than the opening 65 , and the base end portion 60 B of the balloon 60 is fixed on an outer peripheral surface of the elastic portion 40 . Thereby, since the opening 65 is arranged inside the swelling portion 60 C of the balloon 60 , it is possible to expand and shrink the balloon 60 by supplying and sucking a fluid, such as air, to/from the opening 65 . [0054] In this case, the rubber ring 69 is made to fit outside the concave groove 67 , and the opening 65 which is not selected is sealed with the rubber ring 69 . Thereby, when the fluid is supplied and sucked by the balloon controller 100 , the fluid is supplied and sucked to and from the opening 65 . [0055] When the balloon 60 is mounted in the location of the opening 65 as described above, the balloon 60 is mounted in a base end side further than the bending portion 42 . Hence, it is possible to perform a bending operation of the bending portion 42 freely in a state that the balloon 60 is expanded and the insertion unit 12 is fixed to the inside of the living body (large intestine or the like). Therefore, since it is possible to orient the tip portion 44 to a pathological change portion or the like in a state that the insertion unit 12 is fixed to the inside of the living body, this is suitable for making an endoscope treatment tool, such as a forceps, inserted into a forceps channel of the endoscope 10 to treat the pathological change portion or the like. [0056] In this way, according to this embodiment, it is possible to select a mounting position of the balloon 60 according to an application of a balloon type endoscope. In addition, in the above-mentioned endoscope 10 , since the pipeline 66 is provided in the insertion unit 12 , differently from a case that the pipeline 66 is arranged outside the insertion unit 12 , it is possible to mount the balloon 60 easily, and to secure airtightness between the balloon 60 and insertion unit 12 . [0057] In addition, in the endoscope 10 of this embodiment, since the openings 64 and 65 are provided in the concave grooves 67 and 68 , when the rubber ring 69 is made to fit outside and seal the opening 64 or 65 , it is possible to prevent the rubber ring 69 from projecting from an outer peripheral surface of the insertion unit 12 . Furthermore, in this embodiment, since the openings 64 and 65 are provided in the concave grooves 67 and 68 , it becomes hard for the opening 64 or 65 to be sealed by the balloon 60 when a fluid is sucked from the opening 64 or 65 , and hence, it is possible to shrink the balloon 60 securely. [0058] Furthermore, although the rubber ring 69 is used in the embodiment mentioned above as a sealing device which seals the opening 64 or 65 which is not selected, the sealing device is not limit to this, and may be just a device which seals the opening 64 or 65 , or a branching portion of the pipeline 66 . For example, it is also sufficient to press fit a rubber plug into the opening 64 or 65 , or to seal the opening 64 or 65 by fitting or screwing a plug member into the opening 64 or 65 . In addition, as mentioned later, it is also sufficient to seal the opening 64 or 65 using the tip portion 60 A or base end portion 60 B of the balloon 60 . Furthermore, a pipeline-sealing device such as a solenoid valve may be provided in the branching portion of the pipeline 66 . [0059] In addition, although the example of providing the two openings 64 and 65 is explained in the embodiment mentioned above, the number of the openings is not limited to this, but three or more openings may be provided in an axial direction of the insertion unit 12 . For example, an opening may be provided in an outer peripheral surface of the elastic portion 40 in addition to the openings 64 and 65 mentioned above. [0060] Furthermore, although the opening 64 is provided in the tip portion 44 of the insertion unit 12 and the opening 65 is provided in the connection ring 41 in the embodiment mentioned above, locations of the openings are not limited to this, but what is necessary is just to be formed in different locations in the axial direction of the insertion unit 12 . For example, as shown in FIGS. 6 and 7 , openings 70 and 71 may be provided in the tip portion and base end portion of the connection ring 41 , respectively. The openings 70 and 71 are provided in concave grooves 72 and 73 formed in the outer peripheral surface of the connection ring 41 over a round in a circumferential direction, respectively. Widths of the concave grooves 72 and 73 are formed in widths of the tip portion 60 A and base end portion 60 B of the balloon 60 , respectively. [0061] When the opening 70 is selected in the endoscope constructed as described above, as shown in FIG. 6 , the tip portion 60 A of the balloon 60 is fixed on the bending portion 42 , and the base end portion 60 B of the balloon 60 is fixed in a location of the concave groove 73 . Hence, the opening 71 which is not selected is sealed by the base end portion 60 B of the balloon 60 . [0062] In addition, when the opening 71 is selected, as shown in FIG. 7 , the tip portion 60 A of the balloon 60 is fixed by the concave groove 72 , and the base end portion 60 B of the balloon 60 is fixed by the elastic portion 40 . Hence, the opening 70 which is not selected is sealed by the tip portion 60 A of the balloon 60 . [0063] According to the endoscope constructed as described above, it is possible to select a mounting position of the balloon 60 from a tip portion side and a base end side of the connection ring 41 . In addition, according to this embodiment, since the opening 70 or 71 which is not selected is sealed using the tip portion 60 A or base end portion 60 B of the balloon 60 , it is not necessary to provide a sealing device separately. In addition, according to this embodiment, since the tip portion 60 A or base end portion 60 B of the balloon 60 after mounting are arranged inside the concave groove 72 or 73 by providing the openings 70 and 71 in the concave grooves 72 and 73 , it is possible to prevent the tip portion 60 A or base end portion 60 B from projecting from an outer peripheral surface of the insertion unit 12 . [0064] Moreover, in the case of the above-mentioned endoscope, the balloon 60 may be mounted as shown in FIG. 8 . That is, the tip portion 60 A of the balloon 60 may be fixed in the tip side further than the concave groove 72 , and the base end portion 60 B may be fixed in the base end side further than the concave groove 73 . Thereby, the two openings 70 and 71 are arranged inside the balloon 60 , and supply and suction of a fluid are performed through the two openings 70 and 71 . Hence, it is possible to prevent the balloon from expanding and shrinking with partially uneven. [0065] In addition, although the pipeline 66 is branched and is made to communicate with the openings 64 and 65 , or 70 and 71 in the embodiment mentioned above, the present invention is not limited to this, but an independent pipeline for each of the openings 64 , 65 , 70 and 71 may be provided, and may be connected to the balloon controller 100 .

1a

FIELD OF THE INVENTION The invention relates to a device for the measurement of the size of an eye pupil, comprising at least one light source to illuminate the eye and at least one light detector sensitive to light reflected from the eye. BACKGROUND OF THE INVENTION Qualitative or quantitative observation of the pupilary reflex of human subjects, i.e. the variation of the pupil size caused by external stimuli, is of clinical significance because, from a normal or abnormal behavior of this reflex, conclusions can be drawn on the functional state of the brain structures and nerve tracks that participate in stimulus transmission from the locus of stimulation to the muscle bundles regulating the size of the pupil. Stimuli, apart from optical, may be also acoustical, tactile, thermal or other, thus providing many possibilities to test parts of the neural system. This sort of functional test is most valuable for the clinician when he has to deal with non-collaborating subjects, as, for example, unconscious persons or infants. Methods for measuring the pupillary reflex of collaborating subjects are known. The subject is told to fixate a target with open eye and the pupil is viewed for example by a cinema or television camera before, during and after application of the stimulus or the eye is illuminated with red or infrared light, and the pupil and the iris are imaged onto a photocell. All known methods are, however, applicable only with difficulty to non-collaborating subjects. In the case considered here it has to be supposed that the subject, in general, will hold his eyes closed. Nevertheless, his eyeballs may move in an arbitrary and not foreseeable manner. Even when, in such cases, the eyelids were artificially held open, a reliable measurement of the pupil size by known methods would be rendered considerably less accurate, since the pupil would appear distorted by perspective as a consequence of arbitrary eye movements. SUMMARY OF THE INVENTION The object of the present invention is a device as mentioned above that enables to illuminate the iris of the eye and to detect light reflected by the iris independently from eye movements, and to prevent at the same time stray light reflected by other surfaces than the iris or by the retina from reaching the detectors. According to the present invention the device is characterized by an optical system that collects the diverging light beams emitted by the illumination source and directs them towards the iris; it is further characterized by said illumination source, said optical system and said detectors being built into a contact body designed to adhere to the eye and to be moved with the latter. In such a device said contact body, after being put on the eye, follows each of its movements. It is, moreover, possible to reduce the weight of said body so far that it is readily tolerated by a subject in reclining position. This applies even when a second light source, generating optical stimuli, is incorporated in said body. Since the optical system according to the present invention makes use only of the more divergent parts of the light emitted by the illumination source, directing them obliquely onto the iris through an annular area of the cornea, there remains free space between the cornea and the illumination source around the optical axis of the eye that can advantageously be used to take up the detector(s) and the stimulus source without any interception of the illuminating light. Said oblique illumination of the iris includes the additional advantage that those parts of the illuminating light that pass through the pupil will strike lateral parts of the fundus of the eye, from which reflected light will not reach the detector(s) provided to respond to light reflected by the iris. Since the light-collecting optical system as well as the detector(s) are contained in the contact body adhering to the eye, practically no stray light interfering with the measurement is generated. Relatively strong stray light originates only from optical boundaries between media of high refraction index difference. The detector(s) in the device according to the invention can take up stray light, if any, only from the boundary between the contact body and the cornea. Because there is, however, no air gap between these media, the narrow space being filled with tear or another watery fluid, the index difference is small so that practically no stray light is generated. FIGS. 1 to 6 show some examples of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a cross section of a first embodiment of the device according to the present invention; FIG. 2 is a variant of the contact body of FIG. 1, shown at a reduced scale; FIG. 3 is a cross section of another modification of the device; FIG. 4 is a plan view of body 24 of FIG. 3; FIG. 5 is a cross section of a contact body that is specially suited to application on prematurely and new-born infants; and FIG. 6 is a plan view of the contact body of FIG. 5. DESCRIPTION OF PREFERRED EMBODIMENTS FIG. 1 shows a cross section of an eye-ball 1, with a cornea 2, a conjunctiva 3, an iris 4, a pupil 5, a lens 6, and a retina 7. Adhering to the eye 1 is a contact glass 8 consisting of a transparent material, preferentially a plastic (organic) glass, whose contact surface is adapted to the form of the eye under investigation. Between the eye 1 and the contact glass 8 a thin layer of fluid 9 has been placed in known manner, thus providing optical contact. Two light sources 10 and 11 are rigidly fixed to the contact glass 8, source 10 emitting illumination light and source 11 stimulus light. Also rigidly fixed to the contact glass 8 are several detectors 12, two of them being shown in the figure. The mounts of the light sources and the detectors are not shown, for clarity. Such mounts may, for example, be fixed to a case that can be slid over and fixed to the contact glass 8, said case making, however, no optical contact with those surfaces of the contact glass 8 which act as reflecting surfaces for the illumination light as described below. Electrical leads 13, 14 and 15 for the sources 10, 11 and the detectors 12 are indicated. Whereas the emission of the stimulus light source 11 must lie within the visible range of the spectrum since the retina 7 is expected to respond to it, the contrary applies to the emission of the light source 10. For the latter, therefore, light that is not perceived by the human eye, e.g. infrared radiation, is suitable. The detectors 12, then, have to be sensitive to this same spectral range. Such a separation of the spectral ranges of the illumination and stimulus lights has the additional advantage that stray light from the stimulus source (if any) may easily be withheld from the detectors 12 by optical filters, not shown. For the illumination and stimulus light sources 10 and 11 the use of so-called light-emitting diodes is of advantage; these can be obtained commercially. Such diodes, although not being of high intensity, have a relatively small radiating area, which is favorable for the present device. On the other hand their low intensity is compensated by the fact that the light path from the source to the detectors is relatively short. Nevertheless, it is of interest to use as great a part of the illumination light 10 as possible, in order to make the signal, that is, the variation of the pupil size, as high as possible relative to the unavoidable noise (stray light, instabilities of the detector and the amplifiers). For that purpose the contact glass 8 of the device according to the present invention is conceived as an optical collecting system of a special type which will be described below. Moreover, it is of advantage to provide not only one but several detectors 12 that may work independently or in series. Miniature photo diodes may be used which are commercially available. Their signals are processed electronically in known manner and may be displayed for example by a pen recorder. The contact glass 8 of FIG. 1, as an optical system, exhibits a polished toroidal surface 16 and a polished cylindrical surface 17. (The latter may also be given a slightly conical shape if so required by production necessities). The hollow light cone impinging on said refracting toroidal surface 16, emitted by source 10, is collimated and directed towards the iris by total reflection on said polished cylindrical surface 17. The light is thus concentrated on the plane of measurement as defined by the iris 4 and the pupil 5. Part of the light striking the iris 4 is absorbed, another part is diffusely reflected. A certain percentage of the reflected light reaches the detectors 12 and is recorded. If now the size of the pupil changes, e.g. as a reaction to a light stimulus reaching the retina 7 from the source 11 in the form of the beam 18, the surface of the iris lying within the illuminated area, and therefore the amount of reflected light, change too. The signals of the detectors thus vary as to sign and quantity according to the variation of the pupil size, and their temporal course can be recorded. Any movements of the eye 1 do not influence the results of the measurement because the contact glass 8 and hence all measuring elements as described take part in such movements. Good adherence of the contact glass 8 to the eye 1 can be provided in known manner by slight suction. The bore channel of small diameter necessary for this is not shown in FIG. 1. Another form 19 of the contact glass is shown in FIG. 2. Here the functions of the collimating and the totally reflecting surfaces 16 and 17 of FIG. 1 are taken over by one single polished toroidal mantle surface 20, whereas the entrance surface 21 for the light from source 10 is conical. FIG. 3 shows a third variant of the contact glass. The contact glass 22 differs from the contact glass 8 of FIG. 1 insofar as lenses 23 are provided, each lens forming an image of a certain sector of the iris 4 on one of the detectors 12. In contrast to this, light reflected from any point of the iris can reach all the detectors in the case of FIG. 1. With the device of FIG. 3 it is therefore possible to differentiate the pupillary reaction in respect to certain sectors of the iris. This too is of clinical interest since the coordination of the various muscle bundles responsible for iris movements may be out of order. According to FIG. 3 the lenses 23 of the contact glass 22 are part of a removable body 24. If required, the body 24 may be exchanged for another piece without such lenses. Said body 24 consists of a mount 25 that may be formed, for example, out of an opaque plastic material. This mount serves as a support for a lens body 26 of transparent material, e.g. glass or transparent plastic. The lenses 23 may be given an aspherical form. The detectors 12 are located above the lenses 23 on the upper surface of mount 25. The lens body 26 comprises, in addition, a central lens 27 that serves to direct the stimulus light from source 11 towards the retina (not shown here, see FIG. 1) through the pupil 5. The advantage of providing such a lens is that it can be devised to form an image 27' of the small radiating area of source 11 in the pupil plane, as shown. Since that image will be smaller than the smallest diameter the pupil is able to contract to, the retinal area covered by the stimulus light will be independent of the pupil size, whereas for the device of FIG. 1 it does depend on that size; this is not desirable, however, for well-defined investigations. As for the rest, the contact glass 22 of FIG. 3 corresponds to the contact glass 8 of FIG. 1, especially so concerning the course of the light beams from source 10 to iris 4. As can be seen on the plan view, FIG. 4, of body 24 (without detectors 12), four lenses 23 may be provided, for example. The use of the device described above in several examples is made difficult or impossible when measurements on prematurely or newly born infants are intended, because in these instances the lid fissure is too small to adapt the cylindrical optical system of the contact glass as shown in FIGS. 1 to 3. In FIGS. 5 and 6 a modification of the contact glass is shown that avoids this difficulty. The contact glass 28 possesses a cup-like contact part 29 of similar form to those described above, except that its radius is smaller, thus being adapted to the smaller radius of infantile corneas. The cross section (FIG. 5) of the optical system collecting the light from the illumination source (not shown) is of the same form as that of the contact glasses described above in FIGS. 1 and 3; that is, there is a collimating toroidal surface 30 and a totally reflecting cylindrical surface 31. However, as shown in FIG. 6, the part of the contact glass delimited by these two surfaces is partially cut off. The remaining sectors of the optical system have a width 32 of 5.5 mm, for example, which conforms to the lid fissure of prematurely or new-born infants. Besides, the contact glass 28, like that of FIG. 3, is provided with a recess 33 into which a body with lenses of appropriate dimensions may be fitted, as shown in FIG. 3. Other parts of the device, especially the illumination source and the detectors, not shown in FIGS. 5 and 6, correspond to those described above. Experience has shown that with the device described, measurements of the pupil size on prematurely and new-born infants are possible. It will be obvious to those skilled in the art that various changes may be made without departing from the scope of the invention and the invention is not to be considered limited to what is shown in the drawings and described in the specification.

1a

CROSS REFERENCE TO RELATED APPLICATIONS The instant non-provisional application is a Continuation application of non-provisional application Ser. No. 10/359,492, filed on Feb. 7, 2003, and entitled COMBINED WHEELCHAIR, WALKER, AND SITTING CHAIR. BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to the general art of chairs and seats, and to the particular field of interchangeable, occupant-propelled, and third party-assisted chairs and seats. 2. Discussion of the Related Art Many people who require the use of a walker at times also require a wheelchair, and as with everyone, a sitting chair. Often, these people are required to own more than one device in order to fulfill their needs. Not only is this expensive, it may also be wasteful of space and may require the person to move from one device to another. Space may be an important consideration in nursing and adult homes, and the like, where many people may require use of such devices. This in turn often requires the assistance of another person, thereby inhibiting a person's mobility. While today's walker-chairs offer some similar functionality, they offer neither the safety nor do they fully satisfy all of the needs of certain individuals who at times require the wheelchair function as well. Therefore, there is a need for a combination device which is versatile. The device combines the functions of sitting, standing, ambulation assistance, and assisted and self-propelled transfer (via wheelchair functionality), to be most versatile. Still further, many people have a balance problem. This may make getting into, or out of, a wheel-chair difficult. Some people may require the assistance of another person when getting into, or out of, presently available walker-chairs. If such an assistant is not available, the person may try to hold onto something outside of the chair, such as a table or the like. This may not be safe, especially if the person has a balance problem or is weak. Therefore, there is a need for a combined device which makes getting into, or out of, the device as easy and safe as possible, without requiring the person to hold onto an object located outside the device (which in most cases are non-stationary objects which creates for an unsafe transfer). Armrests on the device provide the necessary safety and comfort feature currently lacking in today's devices. Anything other than armrests is inherently anatomically and physiologically incorrect for people with low balance and muscle weakness. Due to their current structure, walker-chairs are not amenable for use at a table or at a desk because the front beams are not recessed and the chair cannot be pulled beneath the table or desk. If special designs for the tables or desks are required, comfort of the user of the walker-chair would be restricted or the user's mobility may be inhibited. Therefore, there is a need for a combined device which can be used in connection with presently existing tables and/or desks or the like. SUMMARY OF THE INVENTION Briefly stated, it is an object of the present invention to provide a supportive device for use as a wheelchair and a walker. The device includes a pair of handgrips, a seat, and a frame. The frame includes a back portion, a pair of side portions, a seat portion, a pair of rear legs, and a pair of front legs. The pair of rear legs of the frame terminate in wheels. The pair of front legs of the frame terminate in either wheels or caps. The pair of handgrips are pivotally attached to the pair of side portions of the frame, respectively, so as to have a rearwardly-facing position where they face away from the pair of front legs of the frame and a forwardly-facing position where they face towards the pair of front legs of the frame. The seat is pivotally attached to the seat portion of the frame so as to have a horizontal position where it faces the seat portion of the frame and a vertical position where it faces the back portion of the frame. The pair of front legs of the frame terminate in the wheels, the seat is in the horizontal position thereof, and the pair of handgrips are in the rearwardly-facing position thereof so as to allow a person to sit on the seat and face away from the back portion of the frame and have another person stand behind the person, grip the pair of handgrips, and push the supportive device so as to allow the supportive device to be used as the wheelchair. The pair of front legs of the frame terminate in either the wheels or the caps, the seat is in the vertical position thereof, and the pair of handgrips are in the forwardly-facing position thereof so as to allow a person to stand between the pair of side portions of the frame, face the back portion of the frame, grip the pair of handgrips, and push the supportive device so as to allow the supportive device to be used as the walker. BRIEF DESCRIPTION OF THE DRAWING FIGURES FIG. 1 is a front perspective view of the combined device embodying the present invention with wheel units on all legs thereof; FIG. 2 is a side elevational view of the combined device embodying the present invention with caps on the two front legs thereof, the side opposite to the side shown in FIG. 2 being identical thereto; FIG. 3 is a rear elevational view of the combined device embodying the present invention with a back support pillow strapped thereto; FIG. 4 is a perspective view of two caps that are used in the combined device of the present invention; FIG. 5 is a perspective view of two foot rests that are used in the combined device of the present invention; and FIG. 6 is a rear perspective view of a combined device embodying the present invention with a foot pedal mounted on a lower cross brace. LIST OF REFERENCE NUMERALS UTILIZED IN THE DRAWING 10 combined device 12 frame 14 first front leg of frame 12 16 first end of first front leg 14 of frame 12 18 second end of first front leg 14 of frame 12 20 second front leg of frame 12 22 first end of second front leg 20 of frame 12 24 second end of second front leg 20 of frame 12 26 first rear leg of frame 12 28 first end of first rear leg 26 of frame 12 30 second end of first rear leg 26 of frame 12 32 second rear leg of frame 12 34 first end of second rear leg 32 of frame 12 36 second end of second rear leg 32 of frame 12 40 first arm rest of frame 12 42 first end of first arm rest 40 of frame 12 44 second end of first arm rest 40 of frame 12 46 second arm rest of frame 12 48 first end of second arm rest 46 of frame 12 50 second end of second arm rest 46 of frame 12 60 first cross arm of frame 12 62 first end of first cross arm of frame 12 64 second end of first cross arm 60 of frame 12 66 second cross arm of frame 12 68 first end of second cross arm 66 of frame 12 70 second end of second cross arm 66 of frame 12 74 first back rest element of frame 12 76 first end of first back rest element 74 of frame 12 78 second end of first back rest element 74 of frame 12 80 second back rest element of frame 12 82 first end of second back rest element 80 of frame 12 84 second end of second back rest element 80 of frame 12 96 first rear cross brace of frame 12 98 first end of first rear cross brace 96 of frame 12 100 second end of first rear cross brace 96 of frame 12 102 second rear cross brace of frame 12 104 first end of second rear cross brace 102 of frame 12 106 second end of second rear cross brace 102 of frame 12 110 first top brace of frame 12 112 first end of first top brace 110 of frame 12 114 second end of first top brace 110 of frame 12 116 second top brace of frame 12 118 first end of second top brace 116 of frame 12 120 second end of second top brace 116 of frame 12 130 first support brace of frame 12 132 first end of first support brace 130 of frame 12 134 second end of first support brace 130 of frame 12 136 second support brace of frame 12 138 first end of second support brace 136 of frame 12 140 second end of second support brace 136 of frame 12 150 seat 152 back support 154 first end of back support 152 156 second end of back support 152 160 first arm rest cover 162 second arm rest cover 166 first tray mounting element 169 second tray mounting element 170 tray 172 first hand grip pivot mount 174 second hand grip pivot mount 180 first hand grip 182 proximal end of first hand grip 180 184 distal end of first hand grip 180 190 second hand grip 192 proximal end of second hand grip 190 194 distal end of second hand grip 190 200 first sleeve 202 first end of first sleeve 200 204 second end of first sleeve 200 206 cap of first sleeve 200 208 first lock 210 holes through first sleeve 200 212 button on first front leg 14 220 second sleeve 222 first end of second sleeve 220 224 second end of second sleeve 220 226 cap of second sleeve 220 230 second lock 234 holes through second sleeve 220 236 button on second front leg 20 250 first wheel unit 252 second wheel unit 260 first set of rear wheels 262 second set of rear wheels 270 first brake handle 272 second brake handle 274 first brake shoe 276 second brake shoe 280 first connection mechanism 282 second connection mechanism 288 weight 290 back support cushion 292 strap of back support cushion 290 294 first foot rest 296 second foot rest 300 lower cross brace 302 foot pedal DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Other features and advantages of the invention will become apparent from a consideration of the following detailed description and the accompanying drawings. The device embodying the present invention combines the functions of a wheelchair, a walker, and a sitting chair. In the interest of brevity, the combined wheelchair, walker, and sitting chair will be referred to herein as a device. As shown in the figures, the invention is embodied in a device 10 . The device 10 comprises a frame 12 , which includes a first front leg 14 , which extends vertically upward in a use orientation shown in FIG. 1 , and has a first end 16 and a second end 18 , with the first end 16 of the first front leg 14 of the frame 12 being located beneath the second end 18 of the first front leg 14 of the frame 12 in the use orientation. The frame 12 further includes a second front leg 20 , which extends vertically upward in the use orientation, and has a first end 22 and a second end 24 , with the first end 22 of the second front leg 20 of the frame 12 being located beneath the second end 24 of the second front leg 20 of the frame 12 in the use orientation. The frame 12 further includes a first rear leg 26 , which extends upward at an oblique angle in the use orientation, and has a first end 28 and a second end 30 , with the first end 28 of the first rear leg 26 of the frame 12 being located beneath the second end 30 of the first rear leg 26 of the frame 12 in the use orientation. The frame 12 further includes a second rear leg 32 , which extends upward at an oblique angle in the use orientation, and has a first end 34 and a second end 36 , with the first end 34 of the second rear leg 32 of the frame 12 being located beneath the second end 36 of the second rear leg 32 of the frame 12 in the use orientation. The frame 12 further includes a first arm rest 40 , which connects the second end 18 of the first front leg 14 of the frame 12 to the second end 30 of the first rear leg 26 of the frame 12 . The first arm rest 40 of the frame 12 has a first end 42 connected to the second end 18 of the first front leg 14 of the frame 12 , and a second end 44 spaced-apart from the second end 30 of the first rear leg 26 of the frame 12 , with the second end 30 of the first rear leg 26 of the frame 12 being connected to the first arm rest 40 of the frame 12 , at a location between the first end 42 of the first arm rest 40 of the frame 12 and the second end 44 of the first arm rest 40 of the frame 12 . The frame 12 further includes a second arm rest 46 , which connects the second end 24 of the second front leg 20 of the frame 12 to the second end 36 of the second rear leg 32 of the frame 12 . The second arm rest 46 of the frame 12 has a first end 48 connected to the second end 24 of the second front leg 20 of the frame 12 , and a second end 50 spaced-apart from the second end 36 of the second rear leg 32 of the frame 12 , with the second end 30 of the first rear leg 26 of the frame 12 being connected to the second arm rest 46 of the frame 12 , at a location between the first end 48 of the second arm rest 46 of the frame 12 and the second end 50 of the second arm rest 46 of the frame 12 . The frame 12 further includes a first cross arm 60 , which connects the first front leg 14 of the frame 12 to the first rear leg 26 of the frame 12 . The first cross arm 60 of the frame 12 has a first end 62 connected to the first front leg 14 of the frame 12 , at a location between the first end 16 of the first front leg 14 of the frame 12 , and the second end 18 of the first front leg 14 of the frame 12 , and a second end 64 connected to the first rear leg 26 of the frame 12 , at a location between the first end 28 of the first rear leg 26 of the frame 12 and the second end 30 of the first rear leg 26 of the frame 12 . The first cross arm 60 extends parallel to the first arm 40 . The frame 12 further includes a second cross arm 66 , which connects the second front leg 20 of the frame 12 to the second rear leg 32 of the frame 12 . The second cross arm 66 of the frame 12 has a first end 68 connected to the second front leg 20 of the frame 12 , at a location between the first end 22 of the second front leg 20 of the frame 12 and the second end 24 of the second front leg 20 of the frame 12 , and a second end 70 connected to the second rear leg 32 of the frame 12 , at a location between the first end 34 of the second rear leg 32 of the frame 12 and the second end 36 of the second rear leg 32 of the frame 12 . The first cross arm 60 of the frame 12 extends parallel to the second arm 46 of the frame 12 . The frame 12 further includes a first back rest element 74 , which has a first end 76 connected to the first rear leg 26 , adjacent to the second end 64 of the first cross arm 60 of the frame 12 , and extends vertically upward therefrom in the use orientation. The first back rest element 74 of the frame 12 has a second end 78 located above the first end 76 of the first back rest element 74 of the frame 12 in the use orientation. The frame 12 further includes a second back rest element 80 , which has a first end 82 connected to the second rear leg 32 of the frame 12 , adjacent to the second end 70 of the second cross arm 66 of the frame 12 , and extends vertically upward therefrom in the use orientation. The second back rest element 80 of the frame 12 has a second end 84 located above the first end 82 of the second back rest element 80 of the frame 12 in the use orientation. The frame 12 further includes a first rear cross brace 96 , which has a first end 98 connected to the first rear leg 26 of the frame 12 , adjacent to the second end 64 of the first cross arm 60 of the frame 12 , and a second end 100 connected to the second rear leg 32 of the frame 12 . The first rear cross brace 96 of the frame 12 , the first cross arm 60 of the frame 12 , and the second cross arm 66 of the frame 12 are coplanar. The frame 12 further includes a second rear cross brace 102 , which has a first end 104 connected to the second end 78 of the first back rest element 74 of the frame 12 , and a second end 106 connected to the second end 84 of the second back rest element 80 of the frame 12 . The second rear cross brace 102 of the frame 12 is parallel to the first rear cross brace 96 of the frame 12 . The frame 12 further includes a first top brace 110 , which has a first end 112 connected to the second end 78 of the first back rest element 74 of the frame 12 , and a second end 114 . The first top brace 110 of the frame 12 extends parallel to the first arm rest 40 of the frame 12 . The frame 12 further includes a second top brace 116 , which has a first end 118 connected to the second end 84 of the second back rest element 80 of the frame 12 , and a second end 120 . The second top brace 116 of the frame 12 extends parallel to the second arm rest 46 of the frame 12 . The frame 12 further includes a first support brace 130 , which has a first end 132 connected to the second end 114 of the first top brace 110 of the frame 12 , and a second end 134 connected to the first arm rest 40 of the frame 12 , at a location between the second end 30 of the first rear leg 26 of the frame 12 and the first end 42 of the first arm rest 40 of the frame 12 . The first support brace 130 of the frame 12 extends vertically upward from the second end 134 of the first support brace 130 of the frame 12 to the first end 132 of the first support brace 130 of the frame 12 in the use orientation, as shown in FIG. 1 . The frame 12 further includes a second support brace 136 , which has a first end 138 connected to the second end 120 of the second top brace 116 of the frame 12 , and a second end 140 connected to the second arm rest 46 of the frame 12 , at a location between the second end 36 of the second rear leg 32 of the frame 12 and the first end 48 of the second arm rest 46 of the frame 12 . The second support brace 136 of the frame 12 extends vertically upward from the second end 140 of the second support brace 136 of the frame 12 to the first end 138 of the second support brace 136 of the frame 12 in the use orientation. The device 10 further comprises a seat 150 , which is mounted on the first rear cross brace 96 of the frame 12 , the first cross arm 60 of the frame 12 , and the second cross arm 66 of the frame 12 . The device 10 further comprises a back support 152 , which has a first end 154 connected to the first back rest element 74 of the frame 12 , at a location adjacent to the first arm rest 40 of the frame 12 , and a second end 156 connected to the second back rest element 80 of the frame 12 , at a location adjacent to the second arm rest 46 of the frame 12 . The device 10 further comprises a first arm rest cover 160 , which is mounted on the first arm rest 40 of the frame 12 , between the second end 134 of the first support brace 130 of the frame 12 and the first end 42 of the first arm rest 40 of the frame 12 , and a second arm rest cover 162 , which is mounted on the second arm rest 46 of the frame 12 , between the second end 140 of the second support brace 136 of the frame 12 and the first end 48 of the second arm rest 46 of the frame 12 . The device 10 further comprises a first tray mounting element 166 , which is mounted on the first arm rest 40 of the frame 12 , and a second tray mounting element 168 , which is mounted on the second arm rest 46 of the frame 12 . The device 10 further comprises a tray 170 , which is mounted on the first and second tray mounting elements 166 , 168 to support food, work, or the like, for a person sitting in the device 10 . The device 10 further comprises a first hand grip pivot mount 172 , which is located on the first top brace 110 of the frame 12 , and a second hand grip pivot mount 174 , which is located on the second top brace 116 of the frame 12 . The device 10 further comprises a first hand grip 180 , which has a proximal end 182 pivotally mounted in the first hand grip pivot mount 172 , and a distal end 184 spaced-apart from the proximal end 182 of the first hand grip 180 . The first hand grip 180 is pivotally movable between a use position, shown in FIG. 1 , having the first back rest element 74 of the frame 12 located between the distal end 184 of the first hand grip 180 and the proximal end 182 of the first hand grip 180 , and a stored position, shown in FIG. 2 , having the first support brace 130 of the frame 12 located between the distal end 184 of the first hand grip 180 and the proximal end 182 of the first hand grip 180 . The device 10 further comprises a second hand grip 190 , which has a proximal end 192 pivotally mounted in the second hand grip pivot mount 174 , and a distal end 194 spaced-apart from the proximal end 192 of the second hand grip 190 . The second hand grip 190 is pivotally movable between a use position, shown in FIG. 1 , having the second back rest element 80 of the frame 12 located between the distal end 194 of the second hand grip 190 and the proximal end 192 of the second hand grip 190 , and a stored position, shown in FIG. 2 , having the second support brace 136 of the frame 12 located between the distal end 194 of the second hand grip 190 and the proximal end 192 of the second hand grip 190 . The device 10 further comprises a first sleeve 200 , which is telescopingly connectable to the first front leg 14 of the frame 12 . The first sleeve 200 has a first end 202 , a second end 204 , and a cap 206 on the second end 204 of the first sleeve 200 . The device 10 further comprises a first lock 208 , which releasably connects the first sleeve 200 to the first front leg 14 of the frame 12 , and has a plurality of holes, such as holes 210 , defined through the first sleeve 200 , with the holes 210 being spaced-apart from each other, from adjacent to the first end 202 of the first sleeve 200 , toward the second end 204 of the first sleeve 200 . The device 10 further comprises a button 212 on the first front leg 14 of the frame 12 , which is received in one of the plurality of holes 210 of the first sleeve 200 when the first sleeve 200 is connected to the first front leg 14 of the frame 12 . The device 10 further comprises a second sleeve 220 , which is telescopingly connectable to the second front leg 20 of the frame 12 , and has a first end 222 , a second end 224 , and a cap 226 on the second end 224 of the second sleeve 220 . The device 10 further comprises a second lock 230 , which releasably connects the second sleeve 220 to the second front leg 20 of the frame 12 , and has a plurality of holes, such as holes 234 defined through the second sleeve 220 , with the holes 234 being spaced-apart from each other, from adjacent to the first end 222 of the second sleeve 220 , toward the second end 224 of the second sleeve 220 . The device 10 further comprises a button 236 on the second front leg 20 of the frame 12 . The button 236 is received in one of the plurality of holes 234 of the second sleeve 220 when the second sleeve 220 is connected to the second front leg 20 of the frame 12 . One form of the device 10 further comprises a third sleeve telescopingly connectable to the first front leg 14 of the frame 12 . The third sleeve has a first end and a second end. This form also comprises a third lock releasably connecting the third sleeve to the first front leg 14 of the frame 12 . The third lock has a plurality of holes defined through the third sleeve, with the holes being spaced-apart from each other, from adjacent to the first end of the third sleeve, toward the second end of the third sleeve. The button on the first front leg 14 of the frame 12 is received in one of the plurality of holes of the third sleeve when the third sleeve is connected to the first front leg 14 of the frame 12 . This form further comprises a fourth sleeve telescopingly connectable to the second front leg 20 of the frame 12 . The fourth sleeve has a first end and a second end. This form still further comprises a fourth lock, which releasably connects the fourth sleeve to the second front leg 20 of the frame 12 . The fourth lock has a plurality of holes defined through the fourth sleeve, with the holes being spaced-apart from each other, from adjacent to the first end of the fourth sleeve, toward the second end of the fourth sleeve. The button on the second front leg 20 of the frame 12 is received in one of the plurality of holes of the fourth sleeve when the fourth sleeve is connected to the second front leg 20 of the frame 12 . The device 10 further comprises wheel units, such as a first wheel unit 250 and a second wheel unit 252 , which can be connected to either the first and second sleeves 200 , 220 or to the third and fourth sleeves, as desired. The device 10 further comprises a first set of rear wheels 260 , which is mounted on the first end 28 of the first rear leg 26 of the frame 12 , and a second set of rear wheels 262 , which is mounted on the first end 34 of the second rear leg 32 of the frame 12 . The device 10 further comprises a brake unit, which includes a first brake handle 270 on the first hand grip 180 , and a second brake handle 272 on the second hand grip 190 . The device 10 further comprises a first brake shoe 274 , which is on the first set of rear wheels 260 , and a second brake shoe 276 , which is on the second set of rear wheels 262 . The device 10 further comprises first connection mechanism 280 , which operably connects the first brake handle 270 to the first brake shoe 274 , and a second connection mechanism 282 , which operably connects the second brake handle 272 to the second brake shoe 276 . The brake connection mechanisms 280 , 282 may include cables, joints, and the like, such as might be used to connect the hand brake of a bicycle to the brake shoes of the bicycle, as will be understood by those skilled in the art. Thus, the exact structure of the brake mechanisms will not be discussed in detail. Brakes can also be operated by a person sitting in the device 10 using straps or the like, as is known to those skilled in the art. The strap brakes can be used to provide further stability to the device 10 while the person is moving into or out of the device 10 . The first rear cross brace 96 of the frame 12 , the first cross arm 60 of the frame 12 , and the second cross arm 66 of the frame 12 are all located beneath the second ends 134 , 140 of the first and second support braces 130 , 136 of the frame 12 , at a distance sufficient to locate a center of gravity of the frame 12 beneath the second ends 134 , 140 of the first and second support braces 130 , 136 of the frame 12 . The device 10 further comprises a weight, such as a weight 288 , which can be included to further control the location of the center of gravity of the device 10 and thus increase the stability thereof. Another form of the device 10 comprises a back support cushion 290 having straps, such as strap 292 , which releasably engage the back support 152 when the back support cushion 290 is in place, as shown in FIG. 2 . The back support cushion 290 assists in maintaining proper posture. The device 10 may also comprise first and second foot rests 294 and 296 , as shown in FIG. 5 , mounted on the frame 12 . Yet another form of the device 10 , shown in FIG. 6 , comprises a lower cross brace 300 and a foot pedal 302 on the lower rear cross brace 300 . The lower cross brace 300 and the foot pedal 302 provide further control of the device 10 for a person pushing the device 10 . It is understood that while certain forms of the present invention have been illustrated and described herein, it is not to be limited to the specific forms or arrangements of parts described and shown.

1a

FIELD OF THE INVENTION [0001] The present invention relates to carrying cases for delicate or fragile articles such as laptop computers and other electronic equipment, and more specifically a protection system that protects stored articles from the adverse affects of acceleration, shock, and vibrational loads. BACKGROUND OF THE INVENTION [0002] Electronic devices such as laptop computers, DVD players, radio equipment, and non-electronic products, such as survey equipment, are very susceptible to acceleration and shock loads due to their internal circuitry and delicate componentry. As referred to herein, these devices are collectively referred to as “electronic devices.” The electronic devices discussed herein are frequently hand carried and prone to damage from acceleration, shock, or vibration loading that can occur when the devices are inadvertently dropped or impacted during transportation. Previous methods of protecting electronic devices have generally employed padding materials such as foam, rubber and/or other similar compliant materials positioned within the carrying case or attache. Although padding may be somewhat protective, the majority of shock loads associated with a dropped carrying case may still be transmitted to the electronic device since padding is somewhat compressible. In addition, padding materials may be ineffective from protecting an article from acceleration or vibrational loads. [0003] Isolation of an article generally provides improved protection to the electronic device and may include a separate padded compartment in the carrying case. These isolated storage areas are often attached to an internal wall of the carrying case and are usually made of a flexible material that acts somewhat like a spring to dampen shock and acceleration loads originating from outside of the case. Thus there is a significant need for an affordable shock resistant carrying case that can restrain and protect delicate electronic componentry from damage during impact or as a result of acceleration loading. [0004] One prior art method of isolating an electronic device is to add a storage compartment that is partially isolated from the rest of the carrying case. The isolated compartments allow the electronic device to be slid into the case and be oriented such that a portion of the device is at or near parallel with the bottom of the case, and thus suspended above a bottom portion of the case. Generally, the compartment may be equipped with conventional foam or other padding materials to protect the electronic device. In addition, the bottom surface of the compartment may employ flexible fabrics to isolate the electronic device from loads emanating from the bottom of the case that are associated with an impact. However, no case currently exists that provides a selectively adjustable storage compartment for protecting the electronic device in a carrying case in substantially all six directions. Thus, there is a long felt but unsolved need for a carrying case that isolates fragile electronic devices, such as laptop computers, in more than one direction, and that avoids the above-mentioned deficiencies of the prior art. SUMMARY OF THE INVENTION [0005] Accordingly, it is one aspect of the present invention to provide a cost effective and portable carrying case that provides protection from acceleration and shock loads to an electronic device positioned within the carrying case. Thus, in one embodiment of the present invention a portable carrying case or attache is provided that employs a separate compartment for securing an electronic device and that has a suspension system that provides protection in a plurality of directions. [0006] It is another aspect of the present invention to provide a compartment in a carrying case that is capable of providing protection to an electronic device in substantially six directions of travel. More specifically, a combination of flexible materials and conventional padding may be used to absorb loads caused by impact from substantially any direction, thus providing more protection than traditional cases that depend solely on padding for protection. [0007] It is yet another aspect of the present invention to provide a lightweight, cost effective storage case. A shock absorbent or loads resistant case can be made of any number or combination of materials which dictate the weight of the finished product. A substantially indestructible and protective shock absorbent or load resistant case would generally not be feasible to construct because of the significant weight and cost. Thus, materials that are preferably used to protect and isolate electronic devices are generally light, and more specifically, materials such as nylon, Teflon®, elastic fiber, etc. are used. By altering the way these materials are used with each other, and with the addition of padding, an electronic device can be protected in substantially six directions of travel. [0008] It is yet another aspect of the present invention that the compartment that secures the electronic device be expandible. By using certain flexible and expandable materials, an added advantage of expandability emerges. Some cases that do not use flexible materials, or limit their use, commonly have carrying compartments of fixed volumes. A user of a case with a fixed volume may be forced to buy a new case when purchasing a new electronic device. Electronic devices vary in size and shape, and a compartment that is compliant with different electronic devices is of great utility to a user. [0009] It is still yet another aspect of the present invention to provide a case that includes a selectively adjustable storage compartment. More specifically, embodiments of the present invention employ a compartment that includes an adjustable internal panel in combination with adjustable side members that secure the electronic device. In addition, cushioned ribs may be employed that engage the electronic device. The adjustable side members in embodiments of the present include a selective fastening member for engagement to the internal panel. Thus a storage compartment is defined by the adjustable panel, the rear panel of the computer case with perhaps at least one cushioned rib protruding therefrom, and two adjustable side members. By selectively adjusting the location of interconnection of the adjustable side members to the adjustable internal panel, a user can selectively expand and contract the storage compartment to accommodate various sized electronic devices. More specifically, in one embodiment of the internal compartment is preferably adjustable to alter the horizontal dimension, vertical dimension, and depth of the compartment. Thus, the internal storage compartment can be selectively adjusted to secure a variety of different notebook computers with varying widths, heights and thicknesses. In addition, the adjustable internal panel may terminate and be hingedly interconnected to an inside corner of the computer case thereby providing some protection to the device against impacts, as described above. One skilled in the art should appreciate that further protection methods may be employed in conjunction with the adjustable storage compartment as primarily described herein without departing from the scope of the invention. For example. Internal gussets or suspension systems which may be interconnected to internal or external materials and framework may also be utilized. [0010] It is still a further aspect of the present invention that the carrying case and carrying compartment may be designed from inexpensive materials that are well-known in the art. These include nylon, rubber, plastics and other similar materials which are generally flexible and lightweight as opposed to more rigid. [0011] Thus, in one embodiment of the present invention a carrying case with an internal suspension system adapted for supporting and protecting an electronic device, is provided, comprising: [0012] an enclosure defined by a front panel, a rear panel, a bottom panel, a top panel and opposing side panels; [0013] a selective opening means interconnected to at least one of said top panel, said front panel and said rear panel to allow access to an internal portion of said enclosure; [0014] a support platform operably interconnected to an internal portion of said enclosure and elevated above said bottom panel, said support panel adapted to support an electronics device; and [0015] an adjustable lateral restraint means interconnected to an internal surface of said enclosure which is adapted to engage at least two opposing edges of said electronic device to substantially impede lateral movement and within said storage case. [0016] It is a further object of the present invention to provide a method of storing an electronic device in a selectively adjustable case including: [0017] a portable storage enclosure with at least one opening is provided; [0018] inserting an electronics device into a cradle formed by a suspension platform interconnected to an interior of the carrying case, wherein the electronics device is supported above a bottom panel of the carrying case; and [0019] selectively adjusting a first lateral restraint member and a second lateral resistant member to enclose the electronics device and secure the restraint members to the support panel, wherein the electronics device is substantially impeded from inadvertent movement. [0020] The summary of the invention is neither intended nor should it be construed as being representative of the full extent and scope of the present invention. The present invention is set forth in various levels of detail in the Summary of the Invention as well as in the attached drawings and the Detailed Description of the Invention and no limitation as to the scope of the present invention is intended by either the inclusion or non-inclusion of elements, components, etc. as provided herein. Additional aspects of the present invention will become more readily apparent in the detailed description, particularly when taken together with the drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0021] FIG. 1 is a front elevation view of one embodiment of the present invention; [0022] FIG. 2 is a front elevation view of the embodiment shown in FIG. 1 with the front panel removed for clarity, and identifying internal components of an internal suspension system; [0023] FIG. 3 is a front elevation view of the embodiment shown in FIG. 1 with the front panel removed for clarity and showing adjustable side members opened; [0024] FIG. 4 is a left partial cross-sectional view of the invention shown in FIG. 1 with a portion of the front panel removed for clarity; and [0025] FIG. 5 is a front perspective view of the embodiment shown in FIG. 1 with the front panel removed to identify the internal components. [0026] To assist in the understanding of the present invention the following list of components and associated numbering found in the drawings is provided herein: # Component 2 Electronic storage case 4 Front panel 6 Rear panel 8 Top panel 10 Bottom panel 12 Side panel 14 Zipper pull 16 Handle 18 Auxiliary storage compartment 20 Storage compartment 22 Cushioned rib 24 Adjustable support panel 26 First restraint member 28 Second restraint member 30 First fastening member 32 Second fastening member 34 Storage compartment lower surface 36 Electronic device 38 Gusset 40 Strap ring 42 Padding DETAILED DESCRIPTION [0027] Referring now to FIG. 1 , a front elevation view of one embodiment of the present invention is provided herein. More specifically, an electronic device storage case 2 is provided that generally comprises a front panel 4 , a rear panel 6 , a top panel 8 , a bottom panel 10 and opposing side panels 12 positioned between the top panel 8 and the bottom panel 10 . Alternatively, the top panel 8 may be removed and the case 2 interconnected along an upper edge of the front panel 4 and rear panel 6 . Although generally designed to carry a notebook computer, the electronic device storage case 2 may be used to retain and safely store any type of electronic device that may be fragile and prone to breakage. The electronic device storage case 2 shown in FIG. 1 generally includes one or more openings that allow access to the electronic storage case and insertion and removal of the electronic device. The storage compartment may be selectively accessed with the use of one or more zippers 14 , buckles, or other types of opening mechanisms commonly known in the art. Generally, the openings are included in the top panel 8 , but openings may also be positioned in the front panel 4 , rear panel 6 , or within one of the side panels 12 . The electronic storage case 2 may also include a handle 16 and at least one auxiliary storage compartment 18 . The auxiliary storage compartment 18 of one embodiment of the present invention may secure items like address books, compact discs, sunglasses, phones, PDAs, and other similar commonly used items. [0028] Referring now to FIGS. 2 and 3 , a front elevation view of one embodiment with the front panel omitted for clarity is provided herein. More specifically, a storage compartment 20 for receipt of an electronic device is provided. The storage compartment 20 is defined by the rear panel 6 that may include a plurality of cushioned ribs 22 emanating therefrom, an internal support panel 24 , and two adjustable restraint members 26 and 28 . The electronic device is thus supported on one surface by the adjustable internal support panel 24 , or another surface by the cushioned ribs 22 , and its left and right sides by the adjustable restraint members 26 and 28 respectively. A portion of the electronic device is also supported by a lower surface of the storage compartment 20 that also provides some impact isolation since it is spaced from the bottom panel 10 of the electronic storage case 2 . The electronic storage case 2 may also include padding 42 in a variety of locations to provide added protection. The internal support panel 24 in one embodiment includes a first fastening member 30 for selective interconnection to a second fastening member 32 interconnected to both adjustable side members 26 and 28 . These fastening members may comprise hook and loop fasteners, such as Velcro® but other fasteners known in the art such as snaps, buckles or latches, etc. may be employed without departing from the scope of the invention. In order to increase at least one dimension of the storage area, a user selectively disconnects the fastening members, transitions the adjustable support panel 24 towards the rear panel 6 of the case 2 to make the storage compartment 20 thinner or transition the internal support panel 24 away from the rear panel 6 to make the storage compartment 20 thicker and re-interconnect the fastening members. The first adjustable restraint member 26 and second adjustable restraint member 28 provide a means for securing the internal support panel 24 and substantially prevent the movement of the stored device in a direction transverse to the thickness of the electronic storage case 2 . Thus the dimension of storage area may be selectively adjusted to assure that the electronic device is securely retained to avoid unnecessary movement and to provide the flexibility to store electronic devices with different dimensions. [0029] Referring now to FIGS. 4 and 5 , cross sectional and perspective views of one embodiment of the present invention are shown. More specifically, additional detail regarding the storage compartment is provided within the electronic storage case 2 will be appreciated. The storage compartment 20 is defined by cushioned ribs 22 , the internal support panel 24 , the adjustable restraint members 26 and 28 , and a storage compartment lower surface 34 . This lower surface provides a space between the storage compartment 20 and the bottom panel 10 of the electronic storage case 2 thereby at least partially isolating a stored electronic device 36 from the bottom panel 10 of the case to provide some shock isolation. Preferably there is a gap or spacing of at least about 1 inch, and preferably 2-3 inches to prevent the electronic device from impacting a solid surface if the storage case 2 is inadvertently dropped. In addition, the adjustable support panel 24 may be hingedly interconnected to a corner defined by the rear panel 6 and the bottom panel 10 of the electronic storage case 2 . One skilled in the art will appreciate that other interconnection methods can be employed to further isolate the electronic device 36 without departing from the scope of the invention. Further, the front panel 4 of the case may be interconnected to the side panels of the case 2 by gussets 38 . Again, one skilled in the art will appreciate that these gussets 38 may be omitted to allow the front panel 4 to open to a greater extent thereby providing greater access to the interior or the case 2 . Although the handle 8 is primarily shown and described herein, other methods of securing the electronic storage case 2 to an individual, such as a strap (not shown) may be included that is selectively interconnectable to the electronic storage case 2 via a strap ring 40 . [0030] While various embodiments of the present invention have been described in detail, it is apparent that modifications and variations of those embodiments will occur to those skilled in the art. However, it is to be expressly understood that such modifications are within the scope and spirit of the present invention.

1a

RELATED APPLICATIONS [0001] This Application claims priority to German Application No. 102004016855.5, filed Apr. 6, 2004, the entire disclosure of which is hereby incorporated by reference. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] The present invention relates generally to items of clothing that are either self-warming, self-cooling or both. [0004] 2. Description of the Related Art [0005] Known are only the cooling or warming cushions for tempering the temperature of small body areas for medical purposes, e.g. sport injuries. [0006] Clothing which dissipates cold independently is not known. Only body bandages and the so-called cold cushions for sport injuries, etc. which apply the therapeutic effects of cold temperatures are known. [0007] Conventional clothing can only make use of the body temperature. It can either function in an insulating capacity or it can be used to ensure that the body loses heat rapidly. It cannot increase the energy requirements of the body and cannot in itself warm the body. [0008] Conventional clothing cannot suggest to the body that it is in a different climate by the temperature it dissipates. The problem to be solved by this invention was the production of a jacket, trousers, pullover, vest, coat (with or without hood), shoes and men's or women's briefs which can either dissipate warmth or cold to the body and in so doing either increase the energy consumption of the body or warm the whole body or individual body parts of the body. [0009] Therefore, there is an unmet need for self-cooling clothing that increases the energy consumption of the body permitting faster weight loss. Moreover, there is also a need for self-warming clothing that permits sojournment in cooler temperatures without the body needing to use its own energy to produce warmth. Until now, clothing has merely been designed to prevent the body losing its own warmth. SUMMARY OF THE INVENTION [0010] The invention concerns items of clothing made from a water impermeable envelope filled with a medium which is able to store either heat or cold and release this to the body on use of the clothing. The invention provides a practical method of controlling body temperature independently of the external temperature or the body's own temperature. Articles of clothing are provided that comprise a water impermeable envelope defining an outer surface and an inner surface and a space between the outer surface and inner surface. The space between the inner and outer surfaces is substantially filled with a gelatinous heat and/or cold thermal storage medium that is fluid at service temperature. BRIEF DESCRIPTION OF THE DRAWING FIGURES [0011] A preferred embodiment of the present invention is described in detail below with reference to the attached drawing figures, wherein: [0012] FIG. 1 illustrates a cross section of a portion of a water-impermeable envelope of a clothing item consistent with the present invention; [0013] FIG. 2 illustrates a section of a portion of a ridge between plastic layers or a heat seal between panels of articles of clothing consistent with the present invention; [0014] FIG. 3 illustrates various embodiments of panels of articles of clothing consistent with the present invention; [0015] FIG. 4 illustrates an outer surface of a panel consistent with the present invention including an aluminum crepe outer surface; [0016] FIG. 5 illustrates a flexible or stretch material between two panels of an article of clothing consistent with the present invention; [0017] FIG. 6 illustrates a panel of an article of clothing consistent with the present invention having a flexible or stretch material between ridges that are between plastic layers associated with the panel; and [0018] FIG. 7 illustrates a two panels of an article of clothing consistent with the present invention, one with velcro for attaching to a second panel, and the other with snaps for attaching to a second panel. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT [0019] Referring initially to FIG. 1 , the invention concerns items of clothing, e.g. a jacket, trousers, pullover, vest, coat (with or without hood), shoes and men's or women's briefs made from a water impermeable envelope 2 filled with a gelatinous heat and/or cold thermal storage medium 4 which is fluid at service temperature. When the human body is exposed to cold, its energy or calorie consumption increases. The reason for this is that the body attempts to maintain a normal temperature of approx. 36.5 deg. C. The invention can help people who want to accelerate their weight loss by increasing the calories necessarily expended on temperature maintenance while undertaking a sporting activity. The invention's users can cool the clothing in apparatus suitable for this purpose and wear it, e.g. when they train in a fitness studio, thereby losing weight in two respects, firstly by training and secondly by increasing their base energy requirements by wearing the invention. [0020] The human body begins to sweat with physical activity such as sport, or when the external temperature has reached a level where the body uses the cooling effects of evaporation to maintain a normal temperature level. People who do not want to sweat during normal exercising can make as good use of the invention (when cooled prior to exercising) as those who wish to exercise in high temperatures. People in hot, muggy areas who, for example, would like to get away from their air-conditioned hotel in the evening and go for a stroll or visit a nearby restaurant, can maintain a normal body temperature by reducing the invention's temperature to a more pleasant temperature. [0021] If the invention is preparatively “charged” with heat, a large source of warmth can be released to the body from the heat-storing thermal medium. Restaurants, which would like to be able to offer their guests the opportunity to sit outside on beautiful, cool, clear evenings can loan their guests warmth-storing thermal coats allowing them to keep either their whole body or parts of the body warm for long periods of time in the cold. The invention is interesting as a fashion accessory. The invention may be made in transparent plastic (for instance) filled with transparent heat and/or cold thermal storage medium so that the clothes warn under the invention can still be on show in cold temperatures. Items of clothing which dissipate heat independently as individual items are unknown. [0022] Problems inherent in known systems are solved consistent with the present invention by a jacket, trousers, pullover, vest, coat (with or without hood), shoes and men's or women's briefs being made from a water impermeable envelope, e.g. polyurethane or another plastic sheeting material, which in the temperature range −30 degrees Celsius to +100 degrees Celsius is adequately pliable and which is filled with a gelatinous or pliable heat or cold thermal storage medium, fluid at service temperature and which does not solidify at temperatures of less than 0 degrees or lose its plasticity. [0023] In various embodiments, the jacket, trousers, pullover, vest, coat (with or without hood), shoes and men's or women's briefs have two halves, a front and aback, which are sealed together at their edges. Both front and back have cells running horizontally across the body in semi-circles which prevent the thermal material from sagging. Each of the sides is made of two layers of plastic film which have been sealed along their edges. One film has horizontal cells separated by ridges. The cells are formed by extruding the film, i.e. swelling it out or in. The cells are filled with heat and/or cold thermal storage material. The second film is laid flat onto the first and sealed along the ridged area of the cells. [0024] Referring now to FIG. 3 , in various embodiments, the jacket, trousers, pullover, vest, coat (with or without hood), shoes, men's and women s briefs are divided into rectangular or square cells 10 by way of ridges 12 , such as ridge or heat seal 6 of FIG. 2 , to ensure even distribution of the thermal gel. Each of the two sides is made of two layers of plastic film which have been sealed along their edges 8 . In various embodiments, one film has horizontal and vertical cells separated by ridges forming a crosshatch pattern of substantially quadrilateral-shaped cells. In various embodiments, the cells are square or rectangular in configuration. The cells are formed by extruding the film, i.e. swelling it out or in. The cells are filled with heat and/or cold thermal storage material. The second film is laid flat onto the first and sealed along the ridged area of the cells. [0025] Referring now to FIG. 4 , in various embodiments, the jacket, trousers, pullover, vest, coat (with or without hood), shoes, men's or women s briefs have an external thermal insulating layer of, e.g. aluminum crepe foil 14 or thin foam sheeting which in turn is coated with aluminum crepe or foil type material. [0026] Referring now, to FIG. 5 , in various embodiments, a stretch material lining 16 is inserted or sewn between the two adjacent halves of the jacket, trousers, pullover, vest, coat (with or without hood), shoes, men's or women's briefs so that the clothing fits snugly. Such stretch material can comprise an elastic band or any number of flexible, elastic, and/or stretchable materials that are known in the art of clothing manufacture. [0027] Referring now to FIG. 6 , in various embodiments, the jacket, trousers, pullover, vest, coat (with or without hood), shoes, men's or women s briefs have stretch material 22 inserted between the adjacent rectangular or square cells 20 so that the clothing fits snugly. [0028] Referring now to FIG. 7 , in various embodiments, the jacket, trousers, pullover, vest, coat (with or without hood), shoes, men's or women s briefs the inner lining of the garment s made of a comfortable material such as cotton (not shown) and may be attached by means of Velcro 24 or snap fasteners 26 . [0029] The advantage of the invention is that the jacket, trousers, pullover, vest, coat (with or without hood), shoes, men's or women's briefs can be cooled and influence the body temperature in such a way that the body uses more energy and/or does not begin to sweat. Anyone wishing to lose weight can wear the cooled clothes and burn more calories. People who want to be able to be outside in hot places can avoid sweating; as can people who are exposed to the heat of stage spotlights. The advantage of the invention is that the jacket, trousers, pullover, vest, coat (with or without hood), shoes, men's or women's briefs can be “re-charged” with heat. The body does not then have to compensate for cold temperatures itself, but receives external warmth. This thereby makes it quite possible to rest in one position in cooler temperatures, staying comfortable and warm. It would therefore be possible for cafes, for example, to have the invention available for their guests who would like to sit outside on beautiful but cool spring and autumn days. The invention can also be manufactured as a transparent fashion accessory so that whatever is worm underneath the invention is still visible. The invention could also be used to create a more pleasant feeling for people with poor blood circulation who feel cold.

1a

RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Application Ser. No. 60/997,461 filed on Oct. 7, 2007 and is a continuation-in-part of U.S. patent application Ser. No. 11/244,944 filed on Oct. 5, 2005, which is now U.S. Pat. No. 8,088,144, which claims the benefit of U.S. Provisional Application Ser. No. 60/677,859, filed May 4, 2005. This application is related to U.S. patent application Ser. No. 10/687,848 filed Oct. 17, 2003 and U.S. patent application Ser. No. 10/850,795, filed May 21, 2004, the disclosures of which are incorporated in their entirety herein. FIELD OF THE INVENTION The present invention relates generally to apparatus and methods for sealing or closing passages through tissue, and more particularly to devices for sealing punctures or other openings communicating with body lumens, such as blood vessels, and to apparatus and methods for delivering or deploying such devices. BACKGROUND OF THE INVENTION Catheterization and interventional procedures, such as angioplasty and stenting, generally are performed by inserting a hollow needle through a patient's skin and muscle tissue into the vascular system. This creates a puncture wound in a blood vessel, frequently the femoral artery, which, once the interventional procedure has been completed, needs to be closed or sealed in a suitable manner. Procedures and devices have been proposed for accomplishing such closure which involve the use of an introducer sheath that is placed in the tract of the puncture wound following which a closure delivering device is introduced through the introducer sheath to deploy a sealing element within the tract. An indicator wire may be used to locate the edge of the tract. After the closure delivering device deploys the sealing element, the indicator wire and the device are retracted. Examples of such procedures and devices are disclosed in application Ser. No. 10/687,848, filed Oct. 17, 2003 and Ser. No. 10/850,795 filed May 21, 2004. In these procedures and devices, it would be desirable to exploit features of the patient's anatomy to optimize sealing of the puncture wound. SUMMARY OF THE INVENTION A method for sealing a puncture, having an edge, in a wall of a lumen of a body comprising: deploying a deployment member of a sealing device through an elastic tissue membrane adjacent the wall of the lumen and the puncture, wherein the sealing device includes a sealing element; positioning the sealing element adjacent the wall of the lumen; retracting the deployment member relative to the sealing element to stretch the tissue membrane away from the wall of the lumen; retracting the deployment member relative to the sealing element to allow the tissue membrane to engage the sealing element; and retracting the device from the body. In a preferred embodiment of the invention, the method is performed on a puncture wound in the femoral artery. In the noted embodiment, the elastic tissue membrane is a fascia layer and may comprise a portion of the femoral sheath. In one aspect of the invention, the sealing element is positioned between the tissue membrane and the wall of the artery lumen when the membrane engages the sealing element. Alternatively, the sealing element partially protrudes from the tissue membrane when the membrane engages the sealing element. Preferably, the membrane retains the sealing element at a desired position adjacent the wall of the lumen. Also preferably, the tissue membrane urges the sealing element against the wall of the lumen. In a further embodiment of the invention, the sealing device further includes an indicator wire having a distal tip; and the method further comprises the steps of extending the indicator wire out of the deployment member when the sealing device is deployed through the puncture; adjusting the position of the sealing device until the indicator wire is adjacent to the edge of the lumen puncture; and retracting the indicator wire into the device. In another aspect of the invention, the method for sealing a puncture comprises the steps of deploying a deployment member of a sealing device through an elastic membrane adjacent the wall of the lumen and the puncture, wherein the sealing device includes a sealing element; positioning the sealing element within the lumen; withdrawing the sealing element outside the lumen adjacent the wall of the lumen; frictionally engaging the membrane with the deployment member; retracting the deployment member relative to the sealing element to stretch the membrane away from the wall of the lumen; disengaging the deployment member from the membrane; and retracting the device from the body. In a further aspect of the invention, the method for positioning a sealing element within a puncture comprises the steps of deploying a deployment member of a sealing device through an elastic membrane adjacent the wall of the lumen and the puncture; positioning a sealing element carried by the sealing device within the lumen, partially withdrawing the sealing element from the lumen such that the sealing element is disposed partially within the lumen and partially within the puncture when the membrane is elastically displaced; retracting the deployment member to elastically displace the membrane away from the wall of the lumen; deploying the sealing element by releasing it from the sealing device; disengaging the deployment member from the membrane, wherein the membrane elastically holds the sealing member within the puncture and partially within the lumen; and retracting the device from the body. In yet another aspect of the invention, the method for positioning a sealing element adjacent a puncture comprises the steps of deploying a deployment member of a sealing device through an elastic membrane adjacent the wall of the lumen and the puncture; positioning a sealing element carried by the sealing device adjacent the wall of the lumen, wherein the sealing element is configured to be disposed between the wall of the lumen and the membrane when the membrane is elastically displaced; retracting the deployment member to elastically displace the membrane away from the wall of the lumen; deploying the sealing element by releasing it from the sealing device; disengaging the deployment member from the membrane, wherein the membrane elastically urges the sealing member against the wall of the lumen; and retracting the device from the body. Other systems, methods, features and advantages of the invention will be or will become apparent to one with skill in the art upon examination of the following figures and detailed description. It is intended that all such additional systems, methods, features and advantages be included within this description, be within the scope of the invention, and be protected by the accompanying claims. DESCRIPTION OF THE DRAWINGS In order to better appreciate how the above-recited and other advantages and objects of the present inventions are obtained, a more particular description of the invention briefly described above will be rendered by reference to specific embodiments thereof, which are illustrated in the accompanying drawings. It should be noted that the components in the figures are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the invention. Moreover, in the figures, like reference numerals designate corresponding parts throughout the different views. However, like parts do not always have like reference numerals. Moreover, all illustrations are intended to convey concepts, where relative sizes, shapes and other detailed attributes may be illustrated schematically rather than literally or precisely. FIG. 1 illustrates a side-view of a sealing element deployment device in accordance with a preferred embodiment of the present invention. FIG. 2A illustrates a side-view of a sealing element deployment device in accordance with a preferred embodiment of the present invention. FIG. 2B illustrates a side-view of a sealing element deployment device in accordance with a preferred embodiment of the present invention. FIG. 2C illustrates a side-view of a distal portion of the sealing element deployment device in accordance with a preferred embodiment of the present invention. FIG. 2D illustrates a side-view of a distal portion of the sealing element deployment device in accordance with a preferred embodiment of the present invention. FIG. 3 illustrates a perspective view of components of a sealing element deployment device in accordance with a preferred embodiment of the present invention. FIGS. 4( a - b ) illustrate a distal portion-of the device in accordance with a preferred embodiment of the present invention. FIGS. 5( a - b ) illustrate a top view of a window portion of the sealing element deployment device in accordance with a preferred embodiment of the present invention. FIG. 6 illustrates a perspective view of a window portion of the sealing element deployment device in accordance with a preferred embodiment of the present invention. FIG. 7 illustrates a schematic view of the fascia being stretched away from the vessel wall by the deployment device in accordance with a preferred embodiment of the present invention. FIG. 8 illustrates a schematic view of the fascia retaining the sealing element against the vessel wall in accordance with a preferred embodiment of the present invention. FIG. 9 illustrates another schematic view of the fascia retaining the sealing element against the vessel wall in accordance with a preferred embodiment of the present invention. FIG. 10 illustrates another schematic view the fascia retaining the sealing element against the vessel wall in accordance with a preferred embodiment of the present invention. FIG. 11 is a photographic reproduction of a cross section of tissue showing the fascia retaining the sealing element against the vessel wall in accordance with a preferred embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION A device 100 for deploying a detachable sealing element 160 (shown in FIG. 2 ) in a puncture wound is shown in FIG. 1 , herein referred to as a closure device 100 . Examples of such a sealing element or plug 160 are described in U.S. application Ser. No. 10/687,848, filed Oct. 17, 2003, Ser. No. 10/850,795 filed May 21, 2004, and Ser. No. 11/038,995, filed Jan. 19, 2005, each of which applications are hereby incorporated by reference. Sealing element 160 occludes blood flow from a puncture. In a preferred embodiment, the sealing element 160 will be fabricated from a material which may expand upon contact with blood, such as a felt made from polyglycolic acid and/or polylactic acid polymers or copolymers or other materials such as collagens. The sealing element 160 may also have one or more hemostasis, antibiotic or other therapeutic agents added to it. Alternatively, in other preferred embodiments, the sealing element 160 will be made in such a manner that it will expand spontaneously or upon removal of a restraining force. In still other embodiments, the sealing element 160 can be expandable mechanically, hydraulically or pneumatically. In all such embodiments, it is preferred that the sealing element 160 be fabricated from a bioabsorbable material. A presently preferred embodiment employs needle-weaved polyglycolic acid (PGA) fibers that degrade through chemical hydrolysis of unstable bonds in the crystalline phase to lactic acid and glycolic acid, followed by enzymatic attack and participation in the Kreb's cycle to metabolize to carbon dioxide and water. In one embodiment, sealing element 160 exhibits modest expansion in the range of approximately 0-15%. The closure device 100 for deploying the sealing element 160 includes a tubular elongate member 1 , herein referred to as the “housing,” which houses various components that will be described below. The device 100 also comprises a wire actuator 2 which is external and distal to the housing 1 and is slidably mounted and configured to actuate an indicator wire 6 , as described below. Extending through the distal end of the housing 1 is a deployment tube 7 configured to be received by an introducer sheath 300 known in the art. The deployment tube 7 is slightly longer than the introducer sheath 300 . The deployment tube 7 receives an indicator wire 6 (shown in FIGS. 2 a and 2 b ) and a plunger 80 , which operates as a backing member supporting a detachable sealing element 160 at a distal section of the deployment tube 7 . The plunger 80 preferably includes a channel through which the indicator wire 6 may be received within the tube 7 . The channel is preferably located on or near the edge or the periphery of the backing portion of the plunger 80 , i.e., near the internal surface of the deployment tube 7 . Optionally, an indicator wire tube or other lumen (not shown) may be provided within the interior of the deployment tube 7 . The indicator wire tube is preferably attached to the housing 1 at its proximal end, and extends through the deployment tube 7 . The indicator wire 6 then extends through the indicator wire tube or other lumen and exits the indicator wire tube at or near the distal end of the deployment tube 7 . (Additional details of the structure and operation of the plunger 80 are described in Ser. No. 10/850,795, filed May 21, 2004, which is incorporated by reference.) The deployment tube 7 includes an inlet port 22 in the distal section of the tube 7 , configured to take in blood when exposed to a vessel, and the housing 1 includes an outlet port 23 communicatively coupled to the inlet port 22 for allowing the blood to exit outside of the puncture wound. Also extending out of the housing is a trigger 8 that preferably includes a rotary link 14 configured to deploy the detachable sealing element 160 . Before operation of the closure device 100 , the rotary link 14 is locked, i.e., the operator is prevented from actuating the rotary link 14 despite pressing the trigger 8 , as described below. Turning to FIGS. 2(A-D) , deployment of a detachable sealing element 160 within a puncture wound 400 using the closure device 100 is illustrated. An introducer sheath 300 is already deployed within the tract 410 of the wound 400 with its distal end 310 exposed within the lumen 420 of a blood vessel defined by a vessel wall 430 . The deployment tube 7 of the closure device 100 is inserted into the introducer sheath 300 . As shown, the distal end of deployment tube 7 has a uniform diameter and sealing element 160 is disposed within it. Upon substantially complete insertion, the device 100 is engaged with the introducer sheath 300 , and the distal section of the deployment tube 7 extends out of the distal end of the sheath 300 . When the inlet port 22 is exposed to the lumen 420 of the vessel 430 , blood will enter the inlet port 22 and travel out of the outlet port 23 extending out of the housing 1 . The blood exiting the outlet port 23 will be visible to the operator (not shown) of the device 100 , notifying the operator that the distal end of the deployment tube 7 is within the lumen 420 of the vessel 430 and outside of the tract 410 of the puncture wound 400 . Also, upon substantially complete insertion, the wire actuator 2 of the device 100 is actuated by the proximal end of the sheath 300 , causing the wire actuator 2 to be pushed toward the housing 1 . The wire actuator 2 is mechanically coupled to the indicator wire 6 and configured to actuate the indicator wire 6 in the distal direction. Thus, as the wire actuator 2 is pushed towards the housing 1 , the wire actuator 2 causes the indicator wire 6 to extend out of the distal end of the deployment tube 7 . When the indicator wire 6 exits the tube 7 , the distal section of the wire 6 forms into a loop 5 located adjacent the distal tip of the tube 7 . The loop 5 of the wire 6 will come into contact with the vessel wall 430 near the edge 415 of the tract 410 when the device 100 and the sheath 300 are withdrawn, as shown in FIG. 2 b. Turning to FIG. 2 b , after the device 100 is inserted and engaged into the sheath 300 as described above, the operator withdraws or pulls back the device 100 and sheath 300 within the tract 410 . When the distal section of the deployment tube 7 exits the lumen 420 and enters the tract 410 , the inlet port 22 is no longer exposed to the blood within the lumen 420 and thus, the blood flow out of the outlet port 23 ceases. This notifies the operator that the distal section of the deployment tube 7 has exited the lumen 420 and entered the tract 410 of the puncture wound 400 . The indicator wire's 6 resistance that is caused by the loop 5 engaging the vessel wall 430 will unlock the rotary link 14 , as described below, and optionally toggle the indicator window 13 to a state that indicates that the loop 5 has engaged the vessel wall 430 near the edge 415 of the tract 410 , which places the distal end of the deployment tube 7 at a desirable location within the tract 410 and substantially adjacent to the edge 415 . In the embodiment shown in FIG. 2 b , the indicator window 13 toggles from a striped pattern, FIG. 2 a , to a solid pattern, as described below. The operator is then enabled to actuate the unlocked rotary link 14 to deploy the sealing element 160 by pressing the trigger 8 . Turning to FIGS. 2C and 2D , the rotary link 14 actuates and withdraws both the wire 6 and the tube 7 while the sealing element 160 remains substantially in place by the pusher 80 , thereby deploying the sealing element 160 . The device 100 then disengages from the sealing element 160 , thus sealing or plugging the puncture wound 400 . Preferably, in one motion, the rotary link 14 is configured to withdraw the indicator wire 6 into the tube 7 before the tube 7 is withdrawn. Thus, the wire 6 is withdrawn before the sealing element 160 deployed, preventing the wire 6 from interfering with the deployment of the sealing element 160 , such as damaging or dislodging the sealing element 160 . Turning to FIG. 3 , a rack and pinion system for actuating the tube 7 and the wire 6 within the housing 1 of the device 100 is shown. The device 100 is shown not engaged to an introducer sheath 300 , and thus the wire actuator 2 is in its original state away from the housing 1 . The wire actuator 2 is coupled to a first rack 4 that is configured to engage a first gear 3 when the wire actuator 2 is actuated in the proximal direction as described above. The first gear 3 is attached to a second gear 16 , which causes a second rack 50 to move in the distal direction. The second rack 50 is engaged with the indicator wire 6 , causing the indicator wire 6 to extend out of the tube 7 when wire actuator 2 is actuated by engaging with the introducer sheath 300 as described above. The wire actuator 2 proximally withdraws the first rack 4 , which rotates the second gear 16 via the first gear 3 , which then advances distally the second rack 50 , thus advancing distally the indicator wire 6 , causing the indicator wire to extend out of the deployment tube 7 . The first and second gears 3 and 16 share an axis that is secured by a bottom plate 101 . The bottom plate 101 is actuated by a trigger that includes a rotary link 14 . When the trigger 8 is pressed to deploy the plug 160 , the rotary link 14 , which includes an arcuate gear section 15 that engages and actuates the bottom plate 101 in the proximal direction, is actuated. A tube collar 115 , which is engaged to the deployment tube 7 , is anchored at a distal portion of the bottom plate 101 . When the bottom plate 101 is withdrawn proximally, the collar tube 115 is withdrawn as well, which in turn withdraws proximally the deployment tube 7 , which deploys the plug 160 . Proximally withdrawing the bottom plate 101 causes the first gear 3 to rotate along the first rack 4 , which is locked in place by the wire actuator 2 engaged with the introducer sheath 300 . Proximal to the wire actuator 2 is a post 116 that extends from the housing 1 . When the distal portion of the closure device 100 is inserted into the lumen of the introducer sheath 300 , a proximal portion of the introducer sheath 300 that defines a lip (not shown) engages the post 116 , which connects and locks the closure device 100 to the introducer sheath 300 . Thus, the second rack 50 is proximally withdrawn by the second gear 16 , which causes the indicator wire 6 to retract substantially simultaneously with the deployment tube 7 . The figures show that the first gear 3 has a smaller diameter than the second gear 16 . First and second gears 3 and 16 each provide a mechanical advantage to the control of the indicator wire 6 and deployment tube 7 respectively. Preferably, the mechanical advantage regarding the indicator wire 6 is 4:1 and the mechanical advantage regarding the deployment tube 7 is 2:1. Other mechanical advantage relationships may be used e.g., 3:1 for the indicator wire 6 and 1.5:1 for the tube 7 . It is preferred that the mechanical advantage for the indicator wire 6 be twice that for the tube 7 . Thus, when trigger 8 is depressed, the bottom plate 101 and tube collar 115 will withdraw the tube 7 more slowly than the indicator wire 6 is withdrawn into the device 100 and the indicator wire 6 will be retracted into the deployment tube 7 before the sealing element 160 is deployed and/or disengaged from the tube 7 and the device 100 . As described above, this advantageously prevents the indicator wire 6 from interfering with the deployment of the sealing element 160 . One of ordinary skill in the art will appreciate that though a rack and pinion system is described and shown in FIG. 3 , any suitable type of actuating system may be configured to retract the indicator wire 6 before a sealing element 160 is deployed and/or disengaged from the device 100 in accordance with a preferred embodiment of the present invention. For example, a hydraulic, electronic, and/or a pulley system may be used instead of or in addition to the rack and pinion system to retract the indicator wire 6 into the deployment tube 7 before the sealing element 160 is deployed and/or disengaged from the device 100 . The housing 1 can also include an indicator assembly 200 coupled to a stationary top plate 150 of the device 100 . The indicator assembly 200 can indicate to the operator, via an indicator panel 13 in the top plate 150 , whether the distal end of the deployment tube 7 is in the desired location, e.g., near the edge 415 of the tract 410 of the puncture wound. In addition to, or in the alternative, the indicator assembly 200 may further lock the trigger 8 until the deployment tube 7 is in the desired location. In FIGS. 4A and 4B , an implementation of the indicator assembly 200 of the device 100 is shown. The indicator assembly 200 comprises an indicator 20 , indicator spring 19 and lockout plate 17 . As can be seen from FIG. 4A , a slidable lockout plate 17 engages groove 18 in rotary link 14 , thereby preventing substantial movement of rotary link 14 . The indicator spring 19 applies a proximal force on the lockout plate 17 to maintain the lockout plate's 17 position even after the indicator wire 6 is deployed from the tube 7 . Turning to FIG. 4B , the indicator wire 6 is fixedly attached to the lockout plate 17 , which is coupled to a block 9 via the indicator spring 19 . The block 9 is in a secured position, fixed to the housing 1 and/or the tube 7 . Because the indicator wire 6 is connected to the tube 7 and/or housing 1 via a spring 19 and slidable lockout plate 17 , the indicator wire 6 is capable of axial movement independent of the housing 1 and/or tube 7 . During operation, after the indicator wire 6 has been deployed through the puncture wound 400 with the formed loop 5 exposed to the lumen 420 of a vessel defined by a vessel wall 430 , the operator is then ready to withdraw the device 100 and sheath 300 to deploy the sealing element 160 within the tract 410 of the puncture wound 400 . Even if blood stops flowing out of the outlet port 23 , that only indicates that the inlet port 22 is within the tract 410 , not necessarily that the sealing element 160 is desirably near the edge 415 of the tract 410 . However, the indicator wire 6 may provide such an indication. When the loop 5 of the wire 6 approaches the edge 415 of the tract 410 , the loop 5 will engage the vessel wall 430 near the edge 415 as the device 100 is withdrawn by the operator. When the loop 5 engages the vessel wall 430 , it will cause a force to be applied on the wire 6 toward the distal direction, or direction opposite that of the device 100 as its being withdrawn. This force will overcome the force of the spring 19 securing the lockout plate 17 , proximally withdraw the lockout plate 17 in the distal direction, and cause the lockout plate 17 to disengage from the groove 18 of the rotary link 14 , thereby unlocking the trigger 8 . When the trigger 8 is unlocked, because the loop 5 has caught the edge 415 , the distal end of the tube 7 is substantially adjacent to the edge 415 of the tract 410 , which is a desirable location for the deployment of the sealing element 160 . The operator is then enabled to deploy the sealing element 160 . Even though a spring loaded system is described above for locking and unlocking the trigger 8 , one of ordinary skill in the art would appreciate that any locking mechanism may be employed in accordance with an embodiment of the present invention, such as a hydraulic and/or electronic system. In addition to locking and unlocking the trigger 8 , the indicator assembly 200 may also provide a visual and/or audio notification to the operator that the distal end of the tube 7 is in a desirable position. As will be explained in more detail with regard to FIGS. 4A , 4 B, 5 A, 5 B, and 6 , indicator 20 can be seen through indicator panel 13 , which defines two windows 21 , on the top plate 150 and indicates to the user when the appropriate time to press trigger 8 with rotary link 14 has been reached. FIGS. 5A and 5B show a top view looking down through the windows 21 , indicator 20 is provided with opaque portions 22 . The windows 21 preferably have a shape consistent with the shape of markings 22 on the indicator 20 . Thus, prior to the indicator wire 6 being axially displaced opposite of the housing 1 and/or tube 7 , some or all of the windows 21 are clear, but when the indicator wire 6 is axially displaced opposite of the housing 1 and/or tube 7 as described above, markings 22 on the indicator 20 come into correspondence with the windows 21 of the indicator panel 13 as shown in FIG. 5B . When this registration occurs, trigger 8 may be pressed. FIG. 6 essentially shows the same thing as FIGS. 5A and 5B , but from a perspective view. One of ordinary skill in the art would appreciate that though windows 21 are described, the indicator panel 21 may also utilize other mechanisms, such as electronic circuitry, light emitted diodes (LED), and/or other visual and/or audio mechanisms known in the art. For example, the device 100 may be configured such that when the indicator wire 6 engages the vessel wall 430 near the edge 415 of the tract 410 , a circuit (not shown) is triggered within the housing 1 that causes a light to be emitted and/or an audio alarm to be invoked. One of ordinary skill in the art would also appreciate that features of the anatomy of the patient's tissue can cooperate with the sealing element to facilitate the closure procedure. Preferably, the procedures of the invention position sealing element 160 so that structures located in the tissue between the patient's skin and the vessel wall 430 engage sealing element 160 and retain it against edge 415 of vessel wall 430 . For example, the transversalis fascia and the iliac fascia surround the femoral artery, forming the femoral sheath. In this region, the fasciae are relatively thick, fibrous and elastic membranes. As a result, penetration of the fasciae tend to involve a smaller puncture followed by the expansion of the hole in the fasciae to accommodate the size of the instrument forming the puncture. Upon withdrawal of the instrument, the elastic nature of the fasciae will tend to return the hole to a smaller size than the original puncture. As can be seen in FIGS. 7-9 , methods of the invention use these characteristics of the fasciae to help retain sealing element 150 against edge 415 of vessel wall 430 . First, FIG. 7 shows an alternate detail of the operation described above with reference to FIGS. 2 c and 2 d . Introducer sheath 300 has been inserted through puncture wound 400 , through fascia 440 and into lumen 420 of vessel 420 . FIG. 7 shows the withdrawal of deployment tube 7 after sealing element 160 has been positioned adjacent edge 415 of blood vessel 430 . Introducer sheath 300 has been withdrawn already, and now deployment tube 7 is being withdrawn to leave sealing element 160 in position. As shown in FIG. 7 , the elastic nature of fascia 440 tends to close about deployment tube 7 so that as tube 7 is withdrawn, friction pulls fascia 440 away from vessel wall 430 . FIG. 8 shows that withdrawal of deployment tube 7 elastically displaces, or stretches, fascia 440 above sealing element 160 , so that sealing element 160 is positioned between vessel wall 430 and fascia 440 . When the range of travel of fascia 440 has been exceeded, fascia 440 pulls free from deployment tube and engages sealing element 160 has been placed adjacent edge 415 of vessel wall 430 . Given the elastic nature of fascia 440 , the size of the opening formed by introducer sheath 300 will have decreased so that the sheath cannot pass over sealing element 160 . Further, the expandable nature of sealing element 160 described above will tend to prevent it from passing through an opening in the fascia 440 . For example, needle-weaved PGA fibers absorb some blood volume. Accordingly, as can be seen in FIG. 8 , fascia 440 forms a “tent” over sealing element 160 , holding it in position adjacent edge 415 . The elasticity of fascia 440 transmits force to sealing element 160 to urge it against vessel wall 430 and effectively close lumen 420 . Alternatively, FIG. 9 shows another embodiment of the invention. Here, fascia 440 has pulled free from deployment tube 7 before sealing element 160 has been completely exposed. However, fascia 440 has still been stretched away from vessel wall 430 and will constrict about sealing element 160 . The resulting friction of the tissue tract and the fascia retains the sealing element 160 in position adjacent edge 415 and urges sealing element 160 against vessel wall 430 . The expandable nature of sealing element 160 increases its engagement with fascia 440 . FIG. 10 shows an alternative detail of the operation described above with reference to FIGS. 7 and 8 . FIG. 10 shows that after the deployment tube 7 is withdrawn and the sealing element 160 is completely exposed, a portion of the sealing element 160 may be positioned in lumen 420 of vessel 430 and the remaining portion positioned within tract 410 of the wound 400 . In other words, the sealing element may extend beyond edge 415 of vessel wall 430 and into the lumen 420 . The fascia 440 can form a tent completely over sealing element 160 as shown in FIG. 8 or partially over sealing element 160 as shown in FIG. 9 . In addition to the interaction with the fascia 440 , sealing element 160 is also stabilized and retained in position by other factors, including contraction of tissue above the tract. FIG. 11 is a photographic reproduction of a cross section of tissue showing placement of the sealing element. As can be seen, the sealing element is positioned between the fascia and the vessel wall. The elastic nature of the fascia helps retain the sealing element against the vessel wall and position it adjacent the puncture. FIG. 10 also shows that sealing element is preferably sized so that it can be positioned between the vessel wall and the fascia while maintaining the fascia in an elastically displaced position. Generally, the sealing element should be small enough to fit between the vessel wall and the elastically displaced fascia, yet large enough so that the elastically displaced fascia transmits force to the sealing element, holding it against the vessel wall. The procedures of the invention have successfully been used to seal femoral arteriotomies. In one clinical study, average time to hemostasis using the inventive procedure averaged 138±42 sec, with patients undergoing diagnostic catheterization achieving hemostasis in 138±46 sec (45-296 sec) and patients undergoing percutaneous coronary interventions achieving hemostatis in 139±36 sec (36-245 sec) in 42 successful procedures. Notably, 83% of the patients achieved hemostasis by 2 min. Within the same study, average time to ambulation averaged 2.8 hours, with patients undergoing diagnostic catheterization ambulating in 2.78±1.23 hours (0.98-7.02 hours) and patients undergoing percutaneous coronary interventions ambulating in 2.93±1.22 hours (2.17-6.32 hours). In this study, 92% of the patients ambulated within 4 hours. The noted study experienced a 97% success rate (36/37) excluding roll-ins, where hemostasis was achieved within 5 min of plug delivery without closure-related serious adverse effects. Overall, 42 closures were achieved in 47 patients. In the study, no device-related serious adverse effects, including death, stroke, surgical repair, infection requiring hospitalization or bleeding requiring transfusion, were observed and one non-device related effect, a myocardial infarction occurred. In the foregoing specification, the invention has been described with reference to specific embodiments thereof. It will, however, be evident that various modifications and changes may be made thereto without departing from the broader spirit and scope of the invention. For example, preferred embodiments of the invention are directed to sealing femoral arteriotomies and reference is made to the fasciae surround the femoral artery, the femoral sheath. However, the invention can be applied to other lumens and membranes in the body as desired. Further, the reader is to understand that the specific ordering and combination of process actions described herein is merely illustrative, and the invention can be performed using different or additional process actions, or a different combination or ordering of process actions. As a further example, each feature of one embodiment can be mixed and matched with other features shown in other embodiments. Additionally and obviously, features may be added or subtracted as desired. Accordingly, the invention is not to be restricted except in light of the attached claims and their equivalents.

1a

BACKGROUND OF THE INVENTION The invention relates to a method of producing a denture which can be veneered with ceramic or plastics with a metallic microstructure by sintering technology, from a mixture of metal powders and if necessary glass or ceramic powders. A mixing liquid is added to the powder mixture to form a spreadable mass with which the denture is modelled using techniques conventional in dental ceramics on a ceramic model of the prepared tooth used as a bat and is subsequently sintered on the model. Production of a metallic denture for prosthetic treatment in the case of dental sickness or after loss of one or several teeth, as for example inlays, crowns and bridges which can be veneered with ceramic or plastic, or crowns and bridges which are not veneered is done usually with the so-called "lost wax technique", a precise casting technique which ensures good dimensional accuracy. The advantages of crowns and bridges produced in this manner include not only dimensional accuracy but primarily high strength and ductility which must be ensured in the case of larger bridge structures to prevent forced ruptures in the case of overload. On the other hand, the process itself is very time consuming, material-- and equipment--intensive. Because runner bars and spryes are necessary in the case of the lost wax method, a much higher amount of alloy must be used vis-a-vis the weight of the cast denture; this can lead to changes of alloy properties in case of multiple reuse and if not reused it remains as scrap. Another disadvantage of this technique is that in the case of defects in the cast item, repair is not possible, but the entire production process beginning with wax modeling must be repeated. Another method for producing jacket crowns reinforced with metal caps is described in European application No. 0104320. A preformed, folded cap of a metal foil preferably built up from several layers of different metals is placed over the model of the prepared tooth and rotated onto the latter with a suitable tool. When annealed with a Bunsen burner, the superposed folds are sealed, resulting in a metal cap with a wall thickness of roughly 100 microns which is then veneered with a dental ceramic. Cost of labor and equipment is considerably reduced compared to the lost wax method; however, the denture produced in this manner falls far short of the strength properties of a cast denture so that bridges cannot be produced with this process. In addition, the uniform thickness of the metal foil in the case of highly prepared teeth or in the case of large teeth, especially molars, requires a very thick ceramic veneer so that the danger of ceramic failure is very great, especially in the case of posterior teeth. A known method for producing full ceramic crowns is the jacket crown technique in which an aluminum oxide containing ceramic mass is applied to a platinum foil preformed to the shape of the prepared tooth and is sintered. The crown is modeled freely by hand so that the entire equipment necessary to produce cast crowns is not required. The properties of the ceramic mass allow exact modelling of the most complex tooth; shapes. The major disadvantage of this type of denture is the brittleness, a characteristic property of ceramic material, which leads to catastrophic failure in the case of sudden overload. Furthermore the strength is not adequate to produce thick walled crowns and larger bridges. German OS No. 19 15 977 describes a method for producing a denture based on metal or alloy powders with a particle size from 2 to 25 microns which are made into a paste using a binder volatile below the sintering temperature. This paste is freely modelled using a spatula on a exact model of the prepared tooth; the model is used as a bat. The binder is expelled at higher temperatures and the metal particles sintered together. However, this method is subjected to the disadvantage that a high densification of the metal powder mixture cannot be achieved with the paste so that relatively great shrinkage takes place during sintering. The exact fit required for a denture cannot be achieved with this process, even when very fine, spherical powders are used, which on the other hand can only be produced with relatively low output and, therefore, only at high costs. SUMMARY OF THE INVENTION The task of the invention was to develop a method for producing a denture which can be veneered with ceramic or plastic with a metallic microstructure using sintering technology from a mixture of metal powders and if necessary glass or ceramic powders. A mixing liquid is added to the powder mixture to form a spreadable mass with which the denture is modelled with techniques ordinarily used in dental ceramics on a ceramic model of the prepared tooth being used as a bat and is then sintered on the model. In this process shrinkage should be minimized during sintering to maintain a denture with exact fit and with high strength which is for the most part free of open porosity and which can be produced inexpensively. This was done by the invention as follows. The powder mixture has a multimodal size of coarse and fine fractions in which the grain size of the coarsest fraction should not exceed 100 microns. Adding water this powder mixture is converted into a slip. The sintering temperature of the slip composition is selected such that it exceeds the solidus temperature of at least one component of the powder mixture and if the sintered body should be veneered with dental ceramic exceeds the baking-on temperature of the ceramic by at least 50° C. Preferred versions of the method are set forth in the dependent claims. In the method of the invention, a mixture of metal powders of the elements necessary for desired alloy composition in the corresponding quantitative ratios or alloyed powders and in a given case ceramic powders is mixed with water to form a slip with consistency and modelling properties corresponding to conventional dental or veneering ceramics. To maximize bulk density and accordingly minimize shrinkage during sintering, the use of powder mixtures with multimodal size distributions of the metal or ceramic powders used has been found to be essential in which the powders with grain size less than 100 microns must be used. The percentage of ceramic powder should only be of such a magnitude that a metallic matrix is always ensured. The admixed slip is modelled on an exact model of the prepared tooth using techniques and equipment conventional in dental ceramics and is compacted by suitable techniques likewise known in production of ceramic teeth or ceramic veneers (for example, vibrating with the fluted part of a modelling instrument). During the compaction process liquid is expelled; in this way the powder particles can be rearranged into more favorable positions and moved closer together. The model used, consisting of a refractory ceramic, is preferably enlarged for modelling with suitable materials according to known shrinkage of the alloy and insulated against overly great liquid absorption. These procedures yield optimum bulk density of the densified slip and low shrinkage during sintering. To achieve high sintering density a sintering method must be used in which the sintering temperature exceeds the solidus temperature of at least one component of the mixture, whereby efforts must be made to ensure that the sintering temperature exceeds the baking-on temperature of the ceramic by at least 50° C. in the case of intended ceramic veneering. The latter condition must be satisfied to prevent deformation of the metal framework. Depending on the alloy composition. sintering is done in air (for example, precious metals), in a protective gas atmosphere or under a vacuum. After sintering a sufficiently dense denture with a metallic matrix results. Multimodal means that powder mixtures are used with a size distribution with several peaks for different particle sizes. To achieve a high bulk density of the slip mass, those powder mixtures are especially suitable which contain coarse fractions in the range between 30 microns and 100 microns with a percent by volume from 30 to 90% in the overall powder mixture and which exhibit preferably spherical form. As fine powder (less than 50 microns) any form can be used; however, likewise spherical or fleshy powders are preferred. Preferably, the powder components with a solidus temperature greater than the sintering temperature of the slip composition are added as the coarse fraction, while the powder components with a solidus temperature less than the sintering temperature of the slip composition are added as the fine component. If the higher melting components are added as the fine fraction, a rigid skeleton can be formed, because the powder particles sinter during drying or when heated to the firing temperature. Thus densification by particle rearrangement can not occur during liquid phase sintering. The liquid phase which is formed when the liquidus temperature of the low melting powder components is exceeded penetrates into the porous skeleton of the high melting component so that sites previously occupied by them remain as pores. Favorable sintering temperatures for producing a denture using sintering technology are those in the range between the solidus temperature of the sintered alloy T solidus and (T solidus -200° C.;) here the boundary conditions that at least one powder component must have a solidus temperature less than sintering temperature and that the sintering temperature in the case of ceramic facing must lie 50° C. above the baking-on temperature of the ceramic must be considered. The liquid phase can be consumed in full or in part during the sintering process caused by alloy formation which takes place. The use of the described sintering temperatures in the range between T solidus and (T solidus -200° C.) presupposes that the powder mixture consists of at least two metal or alloy powders with different solidus temperatures. In the case that powder mixtures consist of different fractions of only one alloy, a sintering temperature between T solidus and T liquidus can be used to advantage. Part of the alloy is then present as a liquid phase, according to the solid/liquid phase relation. The liquid phase should occur here only to such an extent that stability of the shape of the sintered compact is preserved during sintering. To produce bridges, prefabricated parts, as, for example, wires, sections or metal pouches can be used which are incorporated into the slip during modelling of the crown caps and fixed there by sintering or soldered to the sintered caps. This procedure allows a better fit since the prefabricated parts do not shrink during sintering. another possibility for producing bridges consists in producing the individual teeth as well as the pouches using the method of the invention and then soldering them. To improve fit of the denture, the model of the prepared tooth can be coated with a material which burns without residue, for example wax. The thickness of the coating is such that the circumferential enlargement corresponds to expected shrinkage of the slip composition during sintering. The slip is applied to this coating and condensed. The material which burns without residue is then burned off at a suitable temperature. During sintering the shaped item (for example, a crown) shrinks onto the model so that its shape is accurately reproduced. In addition, before applying the slip, the bat can be coated with a metal which exhibits a melting point higher than that of the alloy to be sintered. Then the slip is applied to the model of the prepared tooth prepared in this manner and liquid phase sintered. The liquid phase wets the metal-coated model and ensures that the alloy fits the form closely even at the margin of the ceramic model. To produce the slip metal powder mixtures are mixed with water preferably containing electrolytes, as, for example, sodium carbonate, sodium hydroxide, or strontium chloride. Mono- or multivalent alcohols can also be added to the water. Thus, there can be added methyl alcohol, ethyl alcohol, isopropyl alcohol, ethylene glycol or glycerine. To produce a well-fitting denture using sintering technology, the green density of the slip composition should be as high as possible before sintering to minimize shrinkage during sintering. This is done as follows. Powder mixtures consisting of one or several metals or metal alloys with bi- or multimodal size distribution are used in which both spherical or fleshy particles or those in any other form can be used. Table 1 lists selected examples of powder combinations. Gold, platinum, and palladium powder of different size distributions and particle forms were used as model powders. Pure spherical powders (material 1) yield a higher base density than pure flaky powders (material 6). The two materials, however, lie outside the invention. By adding additional powders of smaller particle size to multimodal powder mixtures the green density can be significantly increased. The best results are achieved with slip masses with a coarse fraction consisting of spherical particles (Materials 1-5). In addition to size distribution, size and form of the powder used, the sintering temperature is of decisive importance for attainable density and strength. Table 2 lists the properties of sintered alloy Au50 Pt35 Pd15 when using different powder mixtures with multimodal size distribution after sintering. The density values and yield strength 0.2% offset are favorable for use as crown and bridge materials. The yield strengths 0.2% offset of conventional cast dental and bridge alloys likewise fall in the range from 450 to 600 MPa. Alloys produced in this manner exhibit closed porosity; this is important for prevention of plaque deposits and sites of preferred corrosion. Bending tests were carried out for alloys 5 and 7 using specimens 35 mm long with a cross-section 3×3 mm2. The yield strengths observed in the bending test match those of the pressure tests. The sintered alloys, therefore, exhibit sufficient strength vis-a-vis tensile stresses. The considerably higher bending rupture strength R m confirms that plastic deformation takes place before rupture. Base metal containing alloys were also used to produce specimens. To do this, for example, atomized powder of an Au-Sn-In alloy was mixed with Au and Pt powder and sintered at 990° C. To prevent oxidation of Sn and In, the samples to be sintered were placed in a graphite box on a ceramic base and sintered in this box in a conventional ceramic furnace. The compositions can comprise, consist essentially of, or consist of the stated materials. DETAILED DESCRIPTION The following examples will explain the invention in greater detail: EXAMPLE 1 A duplicate consisiting of a refractory, castable ceramic is produced from a master model; the duplicate is later used as the bat. A wax cap is modelled on the duplicated model made of refractory ceramic; the wall thickness of the cap is roughly 0.3 mm. On the one hand, the wax performs the function of insulation against the model stump and on the other hand is used to enlarge the model to compensate for shrinkage which occurs during sintering. The wax cap can be formed from a wax sheet (thickness 0.3 mm) or produced using a dipping wax. A slip is applied to the model prepared in this manner; the slip contains 10% by volume TiO 2 and 90% by volume of a metal-powder mixture. The latter consists of 74.4% by weight Au powder (spherical) with a particle size less than 90 microns, 18.6% by weight Au powder (flaky) with a particle size less than 10 microns and 7% by weight Pt powder (flaky) with a particle size less than 15 microns. Water with 0.5 g/l strontium chloride is used as the mixing liquid. The slip exhibits properties corresponding to those of dental ceramic slips. A veneerable crown cap is made with the slip using techniques conventional in modelling with dental ceramics and tools used for this purpose (brush, spatula, fluting tool, etc.). Upon completion of modelling, the entire configuration is kept for 30 minutes in a dewaxing furnace at 200° C. During this time the wax burns off without residue. Afterwards, the dewaxed configuration is first placed in the drying chamber of the ceramic furnace and dried at 600° C. for 15 minutes, then moved into the firing chamber preheated to 1200° C. and sintered 15 minutes there. After sintering the crown cap is cooled in air and can then be removed from the bat. Ceramic is applied directly to the sintered cap in conventional fashion without intermediate treatment. The crown produced in this manner features a metallic matrix and good fit, in concert with a high strength. EXAMPLE 2 The model is produced and prepared as described in Example 1. The slip admixed with water consists of 10% by volume of TiO 2 and 90% by volume of metal powder mixture which in turn consists of 65.1% by weight Au powder (spherical) of fraction 36-25 microns, 27.9% by weight Au powder (flaky) less than 25 microns and 7% by weight Pt powder (flaky) less than 15 microns. A crown with a occlusal surface is modelled with this slip using techniques conventional in ceramic veneering. Due to the outstanding modelling capacity of the slip, fine details on the occlusal surfaces can be formed. The stages of wax removal, drying and sintering proceed as in Example 1. After sintering, the crown is removed from the bat, the surface fine ground and subsequently polished. This crown also has a good fit. No pores can be recognized. The entire disclosure of German priority application No. P3532331.0 is hereby incorporated by reference. As used in the claims, the term metal is intended to cover pure metals and alloys of two or more metals. TABLE 1__________________________________________________________________________ (μm) □ plateletsPowder form/-size | needles ○ spherical Composition in % by weightMaterialP1 P2 P3 P4 P1:P2:P3:P4 rel. Green__________________________________________________________________________ Density1 ○ 90-71 -- -- -- 100/--/--/ -- 352 ○ 90-71 ○ < 10 -- -- 70/30/--/-- 583 ○ 90-71 ○ < 10 TiO2(<1) -- 68.42/29.33/2.25/-- 604 ○ 90-71 ○ < 10 Bi2O3(<2) -- 66.94/28.68/4.38/-- 735 ○ 90-71 □ < 25 -- -- 90/10/--/-- 566 □ < 50 -- -- -- 100/--/--/-- 9.87 □ < 50 ○ < 10 -- -- 90/10/--/-- 198 □ < 50 □ < 15 (Pt) □ < 15 (Pd) -- 50/35/15/-- 259 □ < 50 ␣ < 15 (Pt) □ < 15 (Pd) TiO.sub.2 (<1) 48.74/34.13/14.63/2.5 47__________________________________________________________________________ TABLE 2__________________________________________________________________________ Rp 0.2Powder form/-size μm Ceramic Additive in MPa Bending test50% Au 15% Pd 35% Pt Amount/% by Vol. Ts/°C. ρ/% compression Rp/MPa Rm/MPa__________________________________________________________________________1 □ < 25 □ < 15 □ < 15 1200 91.8 582 +-432 □ < 25 □ < 15 □ < 15 1300 92.7 700 +-83 □ < 25 □ < 15 □ < 15 + 10 Vol % TiO.sub.2 1200 92.0 631 +-214 □ < 25 □ < 15 □ < 15 + 20 Vol % TiO.sub.2 1200 91.9 656 +-165 □ < 25 □ < 15 □ < 15 + 10 Vol % TiO.sub.2 1300 93.7 710 640 900 +-15 +-30 +-506 □ < 25 □ < 15 □ < 15 + 10 Vol % Bi.sub.2 O.sub.3 1200 92.3 610 +-207 □ < 50 □ < 15 □ < 15 1300 91.8 630 650 864 +-15 +-50 +-1008 □ < 50 □ < 15 □ < 15 + 10 Vol % TiO.sub.2 1300 97.2 720 +-209 □ < 25 ○ < 10 ○ < 10 1300 91.0 566 +-5__________________________________________________________________________ □ platelets ○ spheres

1a

FIELD OF THE INVENTION [0001] The present invention relates to attenuated bacterial mutants, in particular attenuated Salmonella enterica mutants, and to a live attenuated vaccine comprising same. STATE OF THE ART [0002] Salmonellae are Gram-negative, facultative anaerobic, motile, non-lactose fermenting rods belonging to the family Enterobacteriaceae. Salmonellae are usually transmitted to humans by the consumption of contaminated foods and cause Salmonellosis. [0003] Salmonellae have been isolated from many animal species including, cows, chickens, turkeys, sheep, pigs, dogs, cats, horses, donkeys, seals, lizards and snakes. [0004] 95% of the important Salmonella pathogens belong to Salmonella enterica , with S. enterica serovar Typhimurium ( S. Typhimurium ) and S. enterica serovar Enteritidis ( S. Enteritidis ) as the most common serovars. [0005] Salmonella infections are a serious medical and veterinary problem world-wide and cause concern in the food industry. Contaminated food can not be readily identified. [0006] Control of Salmonellosis is important, to avoid potentially lethal human infections and considerable economic losses for the animal husbandry industry. [0007] The ubiquitous presence of Salmonella in nature complicates the control of the disease just by detection and eradication of infected animals. [0008] Several control strategies based on the principles of competitive exclusion and vaccination have been tested to control the infection of e.g. poultry. [0009] Vaccination of farm animals is often considered as the most effective way to prevent zoonoses caused by Salmonella. [0010] Whole-cell killed vaccines and subunit vaccines are used in the prevention of Salmonella infections in animals and in humans with variable results. Inactivated vaccines in general provide poor protection against Salmonellosis. [0011] Live attenuated Salmonella vaccines are potentially superior to inactivated preparations owing to: (i) their ability to induce cell-mediated immunity in addition to antibody responses; (ii) oral delivery with no risk of needle contamination; (iii) effectiveness after single-dose administration; (iv) induction of immune responses at multiple mucosal sites; (v) low production cost; and (vi) their possible use as carriers for the delivery of recombinant antigens to the immune system. [0012] Few live attenuated Salmonella vaccines are actually on the market because results with attenuated mutant strains have not always been good. [0013] For example, poultry has been vaccinated with aro- or cAMP mutants; yet many chicks died shortly after vaccination. As the infection by Salmonella often occurs very early, vaccination of very young chicks is crucial. However, at this age these are very sensitive to Salmonella , possibly due to the immaturity of their immune system. In addition to poor protection of the vaccinated chicks, a prolonged excretion of the vaccine strains was often observed. [0014] Vaccination of birds with the Megan® Vac1 strain, that carries deletions in the cya and crp genes (U.S. Pat. No. 5,389,368; U.S. Pat. No. 5,855,879; U.S. Pat. No. 5,855,880) results in a reduction of the number of birds from which a virulent Salmonella challenge strain can be isolated 7 days after challenge. However, it does not provide a full protection (http://www.meganhealth.com/meganvac.html). [0015] There is thus still a need for improved live attenuated Salmonella vaccine strains, and for improved live attenuated vaccine strains of bacteria infecting veterinary species in general. [0016] Information in literature on the influence of guaB mutations on the virulence of Salmonella and other bacteria is sparse. [0017] McFarland and Stocker (1987 , Microbial pathogenesis 3:129-141) reported on the reduced virulence of guaA and guaB Tn10 insertion mutants of S. Typhimurium and S. dublin in BALB/c mice. At high dosage (2.5×10 7 cfu for S. Typhimurium and 10 4 cfu for S. dublin ), however, these authors reported a high lethality, resulting from the multiplication of the auxotrophic strain. [0018] Wang et al. (2001 , Infection and Immunity 69:4734-4741) reported on pre-clinical trials with a vaccine against typhoid fever in humans. The vaccine of Wang et al. comprised a ΔguaBA mutant of Salmonella typhi . This attenuated strain, however, showed a significant residual virulence in mice. [0019] International patent application WO 99/58146 and U.S. Pat. No. 6,190,669 disclose Salmonella typhi vaccine strains harboring a ΔguaBA mutation, which are used as a live vector to deliver foreign antigens. Aims of the Invention [0020] An object of the present invention is to provide attenuated Salmonella enterica strains. [0021] Another object of the present invention is to provide a live attenuated vaccine against Salmonellosis and methods of prevention based thereon. [0022] Yet another object of the present invention is to provide live attenuated strains which are useful as live vector and as DNA-mediated vaccines expressing foreign antigens. Such strains are highly suitable for the development of vaccines including polyvalent vaccines. [0023] Still another object of this invention is to provide a method to achieve a S. enterica deletion mutant for use in a live attenuated vaccine. [0024] Yet a further object of this invention is to provide the same materials and methods for the preparation of attenuated strains of bacteria infecting veterinary specie, poultry more in particular. [0025] The general aim is to improve food safety and animal health. SUMMARY OF THE INVENTION [0026] A first aspect of the invention relates to an attenuated Salmonella enterica mutant strain which is incapable of forming de novo guanine nucleotides, and wherein said mutant contains a deletion mutation in the guaB gene. [0027] The principle as demonstrated here for S. enterica can be applied to any organism that can use the guanine nucleotide as an intermediary. An aspect of the invention therefore relates to an attenuated mutant strain of a bacterium infecting veterinary species that contains a deletion mutation in the guaB gene. The term “bacterium infecting veterinary species” in the context of the invention refers in particular to bacteria that are pathogenic to veterinary species, and which can be attenuated by a deletion mutation in the guaB gene. The bacterium infecting veterinary species may be a Gram-negative bacterium. Preferred are Gram-negative bacteria for poultry such as Salmonella, Pasteurella, Escherichia coli , etc. Most preferred are Salmonella enterica and (pathogenic) E. coli . By “pathogenic to” is meant that the bacterium, if not attenuated, is capable of causing an infectious disease in the veterinary species. [0028] The mutants of the invention fail to express a functional GuaB gene product. In other words the guaB gene function is impaired, whereby an auxotrophic attenuated strain is obtained. [0029] The mutant strain of the invention, carrying a deletion mutation in the guaB gene, can not grow on Minimal A medium, unless this medium is supplemented with 0.3 mM guanine, xanthine, guanosine or xanthosine. [0030] The present invention in particular aims to provide attenuated S. Enteritidis and S. Typhimurium strains. [0031] Preferably the deletion mutation in the guaB gene is introduced into parent strain S. Enteritidis phage type 4 strain 76Sa88 or into parent strain S. Typhimurium 1491S96. [0032] One of the attenuated S. enterica strains obtained according to the invention is a S. Enteritidis strain SM69 having the deposit number LMG P-21641. Another example is the S. Typhimurium strain SM86 having the deposit number LMG P-21646. [0033] The attenuated mutant strains of the invention are highly suitable for use in a live attenuated vaccine including a polyvalent or multivalent vaccine. The attenuated mutant strain of the invention may encode and express a foreign antigen and may as such be used as a live vector and/or as a DNA-mediated vaccine. [0034] A second aspect of the invention concerns a pharmaceutical composition or a vaccine for immunizing a veterinary species against a bacterial infection (e.g. Salmonellosis caused by Salmonellae) comprising: [0035] a pharmaceutically effective or an immunizing amount of a mutant strain according to the invention, which is incapable of forming de novo guanine nucleotides due to a deletion mutation in the guaB gene; and [0036] a pharmaceutically acceptable carrier or diluent. Preferred compositions are those comprising a Salmonella enterica mutant strain according to the invention. [0037] The attenuated strain of the invention may transfer DNA encoding a foreign antigen in a eukaryotic cell. This foreign antigen may be encoded by and expressed from a plasmid comprised by the attenuated mutant strain of the invention. [0038] In general about 10 2 cfu to about 10 10 cfu, preferably about 10 5 cfu to about 10 10 cfu is administered (examples of a pharmaceutically effective or an immunizing amount). An immunizing dose varies according to the route of administration. Those skilled in the art may find that the effective dose for a vaccine administered parenterally may be smaller than a similar vaccine which is administered via drinking water, and the like. [0039] The attenuated strains of the invention, and pharmaceutical compositions or vaccines comprising same, are highly suitable for immunizing an animal or veterinary species against a bacterial infection (e.g. Salmonellosis) and possibly other diseases (in the case of a multivalent vaccine). [0040] A further aspect of the invention therefore concerns a method of immunizing animals, preferably veterinary species, more preferably poultry such as chicken against an infection by a bacterium (e.g. Salmonellosis caused by Salmonellae), said method comprising the step of: [0000] administering to the animal or veterinary species in need thereof an immunizing amount of an attenuated mutant strain of the invention and/or of a vaccine comprising same, whereby a protective immune response is then invoked in the animal or veterinary species. [0041] Examples of veterinary species to be immunized against Salmonellosis: poultry, small or heavy livestock such as chicken, turkey, ducks, quails, guinea fowl, pigs, sheep, young calves, cattle etc. [0042] In general an appropriate dose is administered to these animals, preferably via the oral, nasal or parenteral route. [0043] A last aspect of the invention relates to a mutant strain of the invention for use as a medicament (e.g. for use in a vaccine). Yet another aspect of the invention relates to the use of an attenuated mutant strain of the invention for the preparation of a medicament, such as a vaccine, for the prevention (and/or treatment) of a disease caused by a pathogen (the infecting bacterium) such as Salmonellosis. Examples of animals or veterinary species to be treated and recommended doses are given above. DETAILED DESCRIPTION OF THE INVENTION [0044] It was surprisingly found that a deletion mutation in the guaB gene can lead to attenuated Salmonella enterica strains with significantly reduced virulence and capable of inducing an immune response in a livestock animal. Such deletion would attenuate any organism that can use the guanine nucleotide as an intermediary. [0045] The term “gene” as used herein refers to the coding sequence and its regulatory sequences such as promoter and termination signals. [0046] The deletion mutant according to the invention is one in which the purine metabolic pathway enzyme IMP dehydrogenase (encoded by guaB) is inactivated. [0047] Such inactivation may be obtained via a deletion by which the guaB gene function is impaired, leading to a null-function (no functional gene product formed) of the affected gene(s). A person skilled in the art knows how to obtain such mutants and a simple test can tell whether the guaB gene function is impaired. The mutant strain which fails to express a functional guaB gene product cannot grow on Minimal A medium, unless this medium is supplemented with (e.g. 0.3 mM) guanine, xanthine, guanosine or xanthosine. [0048] The invention aims to provide, amongst others, attenuated S. Enteritidis and S. Typhimurium strains since these are the most common S. enterica serovars. [0049] The present invention provides attenuated strains. The invention provides amongst others attenuated Salmonella enterica strains for use, inter alia, as live attenuated vaccines against Salmonellosis, as live vector and/or as DNA-mediated vaccines expressing foreign antigens. As used herein, a “foreign antigen” means an antigen foreign to Salmonella. [0050] Live vector vaccines, also called “carrier vaccines” and “live antigen delivery systems”, comprise an exciting and versatile area of vaccinology (Levine et al, 1990 , Microecol. Ther. 19:23-32). In this approach, a live viral or bacterial vaccine is modified so that it expresses protective foreign antigens of another microorganism, and delivers those antigens to the immune system, thereby stimulating a protective immune response. Live bacterial vectors that are being promulgated include, among others, attenuated Salmonella. [0051] An object of the invention is to provide attenuated strains, like attenuated S. enterica strains for use in a live vaccine, possibly a polyvalent or multivalent live vaccine. [0052] One of the objects of the invention is therefore to provide a vaccine against e.g. Salmonellosis comprising: [0053] a pharmaceutically effective or an immunizing amount of a mutant of the invention (e.g. a Salmonella enterica mutant) which is incapable of forming de novo guanine nucleotides, wherein said mutant contains a deletion mutation in the guaB gene; and [0054] a pharmaceutically acceptable carrier or diluent. [0055] Another object of the invention is to provide a live vector vaccine comprising: [0056] a pharmaceutically effective or an immunizing amount of a mutant of the invention (e.g. a Salmonella enterica mutant), which is incapable of forming de novo guanine nucleotides, wherein said mutant contains a mutation in the guaB gene, and wherein said mutant encodes and expresses a foreign antigen; and [0057] a pharmaceutically acceptable carrier or diluent. [0058] The particular foreign antigen employed in the ( S. enterica ) live vector is not critical to the present invention. [0059] Still another object of the invention is to provide a DNA-mediated vaccine comprising: [0060] a pharmaceutically effective amount or an immunizing amount of a mutant of the invention (e.g. a Salmonella enterica mutant), which is incapable of forming de novo guanine nucleotides, wherein said mutant contains a mutation in the guaB gene; wherein said mutant contains a plasmid which encodes and expresses in a eukaryotic cell, a foreign antigen; and [0061] a pharmaceutically acceptable carrier or diluent. [0062] Details as to the construction and use of DNA-mediated vaccines can be found in U.S. Pat. No. 5,877,159, which is incorporated by reference herein in its entirety. Again, the particular foreign antigen employed in the DNA-mediated vaccine is not critical to the present invention. [0063] The decision whether to express the foreign antigen in e.g. S. enterica (using a prokaryotic promoter in a live vector vaccine) or in the cells invaded by e.g. S. enterica (using a eukaryotic promoter in a DNA-mediated vaccine) may be based upon which vaccine construction for that particular antigen gives the best immune response in animal studies or in clinical trials, and/or, if the glycosylation of an antigen is essential for its protective immunogenicity, and/or, if the correct tertiary conformation of an antigen is achieved better with one form of expression than the other (U.S. Pat. No. 5,783,196). [0064] In the vaccines of the present invention, the pharmaceutically effective amount or the immunizing amount of the mutants of the present invention to be administered will vary depending on the age, weight and sex of the subject. By an “immunizing amount” as used herein is in fact meant an amount that is able to induce an immune response in the animal that receives the pharmaceutical composition/vaccine. The immune response invoked may be a humoral, mucosal, local and/or a cellular immune response. [0065] The particular pharmaceutically acceptable carrier or diluent employed is not critical to the present invention, and are conventional in the art. Examples of diluents include: buffer for buffering against gastric acid in the stomach, such as citrate buffer (pH 7.0) containing sucrose, bicarbonate buffer (pH 7.0) alone, or bicarbonate buffer (pH 7.0) containing ascorbic acid, lactose, and optionally aspartame. Examples of carriers include: proteins, e.g., as found in skimmed milk; sugars; e.g. sucrose; or polyvinylpyrrolidone. [0066] The deletion mutants according to the invention have been created via standard homologous recombination techniques, whereby part of the guaB gene, for instance part of the guaB coding sequence, in a first step is replaced by a resistance gene and flanking FRT sites. [0067] Preferably, in a second step, said resistance gene is removed by recombination between the two FRT sites. One FRT site and the priming sites P1 and P2 remain by the molecular mechanism of the recombination removing the antibiotics resistance gene according to Datsenko and Wanner (2000) (see for instance FIG. 4 ). [0068] A particular example of the invention relates for instance to guaB deletion mutants of S. Enteritidis that comprise a mutated guaB gene or coding sequence comprising SEQ ID NO: 12. SHORT DESCRIPTION OF THE DRAWINGS [0069] FIG. 1 is a schematic representation of the biosynthetic pathway of guanosine monophosphate (adapted from Zalkin and Nygaard, 1996, in “ Escherichia coli and Salmonella, Cellular and Molecular Biology, Second edition”, 1996 F. C. Neidhardt ed. ASM Press, Washington D.C., Vol. 1, Ch. 34:561-579). AICAR: 5′-phosphoribosyl-4-carboxamide-5-aminoimidazole; ATP: adenosine triphosphate; G: guanine; GMP: guanosine monophosphate; GR: guanosine; Hx: hypoxanthine; HxR: hypoxanthine riboside (inosine); IMP: Inosine monophosphate; X: Xanthine, XMP: Xanthosine monophosphate; guaA: GMP synthetase, guaB: IMP dehydrogenase; guaC: GMP reductase. [0070] FIG. 2 represents contig 1294 of the S. Enteritidis genome (SEQ ID NO: 10). The ATG initiation codon and TGA termination codon of the guaB gene are in bold. [0071] FIG. 3 represents the sequence of the ΔguaB fragment of S. Enteritidis cloned in pUC18 (SEQ ID NO: 11). The primers that were used are indicated by horizontal arrows. The fragment generated with primers GuaB6-GuaB7 was cloned in pUC18. The ATG initiation and TGA termination codon of the guaB gene and the CCCGGG SmaI restriction site are indicated in bold. [0072] FIG. 4 represents the nucleotide sequence of the S. Enteritidis PCR fragment, which includes the guaB deletion, obtained after sequencing, using primer GuaB10 (SEQ ID NO: 12). The PCR fragment was amplified with primers GuaB6-GuaB7, using total genomic DNA of the mutant SM20. The remaining FRT site is indicated in bold italic and the P1 and P2 primers by arrows (Datsenko and Wanner, 2000 , PNAS 97:6640-6645). The ATG initiation and TGA termination codon of the guaB gene are indicated in bold. [0073] FIG. 5 represents the guaB gene of S. Typhimurium LT2, section 117 of 220 of the complete genome (SEQ ID NO: 13). The ATG initiation codon and TGA termination codon of the guaB gene are in bold. [0074] FIGS. 6-7 represent the deposit receipts of SM69 and SM86 respectively. [0075] The invention will be described in further details in the following examples and embodiments by reference to the enclosed drawings. Particular embodiments and examples are not in any way intended to limit the scope of the invention as claimed. EXAMPLES Example 1 Auxotrophic Mutation Affects the guaB Gene [0076] An auxotrophic insertion mutant of a wild type S. Enteritidis was obtained via insertion mutagenesis. Only when supplemented with 0.3 mM guanine, xanthine, guanosine or xanthosine could the mutant strain grow on Minimal A medium. [0077] These data strongly suggest that the auxotrophic mutation of the strain affects the guaB gene, encoding the enzyme IMP dehydrogenase (EC 1.1.1.205). This enzyme converts inosine-5′-monophosphate (IMP) into xanthosine monophosphate (XMP) as indicated in FIG. 1 . [0078] An insertion mutant can revert, thereby restoring the pathogenicity of the strain. This limits its applicability in a live attenuated vaccine. In that aspect deletion mutants are preferred. guaB deletion mutants of S. Enteritidis and S. Typhimurium were therefore created and tested. The guaB genes of both serovars are given in FIGS. 2 and 5 . Example 2 guaB Deletion Mutants [0079] Construction of guaB Deletion Mutants [0080] guaB deletion mutants were created according to the method for generating deletion mutations in the genome of Escherichia coli K12 (Datsenko and Wanner, 2000 , PNAS 97:6640-5, incorporated by reference herein). [0081] This method relies on homologous recombination, mediated by the bacteriophage λ Red recombinase system, of a linear DNA fragment generated by PCR. [0082] The guaB sequence is hereby substituted by an antibiotic resistance gene. This resistance gene is flanked by FRT sites (FLP recognition target sites) and can be excised from the genome by site-specific recombination, mediated by the FLP recombinase. [0083] Overlap PCR (Ho et al., 1989 , Gene 77:51-59) was applied to construct a linear fragment. The principle relies on the use of two primer sets, one upstream pair (GuaB3-GuaB4; GuaB3: 5′ GGCTGCGATT GGCGAGGTAG TA 3′, SEQ ID NO 2; GuaB4: 5′ GGTGATCCCG GGCGTCAAAC GTCAGGGCTT CTTTA 3′, SEQ ID NO 3) and one downstream pair (GuaB5-GuaB2; GuaB5: 5′ TTGACGCCCG GGATCACCAA AGAGTCCCCG AACTA 3′, SEQ ID NO 4; GuaB2: 5′ CGTTCAGGCG CAACAGGCCG TTGT 3′, SEQ ID NO 1) of the guaB gene. [0084] Both sets contain primers (GuaB4, GuaB5) that are partially complementary and to which a SmaI restriction site was added. [0085] After annealing of the resulting complementary sequences and chain elongation, PCR with the outward primers (GuaB6-GuaB7; GuaBG: 5′ GCAACAACTC CTGCTGGTTA 3′, SEQ ID NO 5; GuaB7: 5′ AGACCGAGGA TCACTTTATC 3′, SEQ ID NO 6) generated a fragment with a 6 basepair SmaI site replacing an 861 basepair internal segment of the guaB coding sequence. This ΔguaB fragment was cloned in the vector pUC18 (see FIG. 3 ). [0086] The chloramphenicol resistance gene (cat) with its flanking FRT sequences was amplified using the primers P1 (5′ GTGTAGGCTG GAGCTGCTTC 3′, SEQ ID NO 8) and P2 (5′ CATATGAATA TCCTCCTTAG 3′, SEQ ID NO 9) (Datsenko and Wanner, 2000) and plasmid pKD3 DNA (Datsenko and Wanner, 2000) as a template. [0087] This PCR fragment was ligated in the SmaI site of the cloned ΔguaB fragment. The desired fragment was generated using nested primers (GuaB6-GuaB7). [0088] The resulting PCR fragment was electroporated into S. Enteritidis phage type 4 strain 76Sa88 (a clinical isolate from a turkey, obtained from the Veterinary and Agrochemical Research Centre, Groeselenberg 99, B-1180 Ukkel, Belgium) harboring the temperature sensitive replication plasmid pKD46, encoding the bacteriophage Lambda Red recombinase system. [0089] The chloramphenicol resistant transformants were tested on Minimal A medium and on Minimal A medium supplemented with 0.3 mM guanine. The ΔguaB::catFRT mutants were confirmed by. PCR using the following primer combinations: GuaB6-GuaB7, GuaB6-P2, GuaB7-P1 and P1-P2. [0090] The S. Enteritidis ΔguaB::catFRT mutant (SM12) was transformed with the temperature sensitive replication plasmid pCP20 by electroporation. The plasmid pCP20 encodes the FLP recombinase, which recognizes the FRT-sites, to remove the cat gene. The resulting strain was named SM20. [0091] The PCR fragment in which the deletion is located was obtained using total genomic DNA of the mutant SM20 and the primer combination GuaB6-GuaB7 (see FIG. 4 ). [0092] The ΔguaB mutation was confirmed by sequencing of this fragment, using the primer GuaB10 (5′ AGGAAGTTTG AGAGGATAA 3′, SEQ ID NO 7). [0093] The sequences of all above-mentioned primers are given in Table 1. [0094] To avoid the presence of possible additional mutations, caused by the expression of the Red recombinase system, an isogenic strain was constructed. [0095] The ΔguaB::catFRT mutation of the mutant SM12 was transduced by bacteriophage P22 HT int − (Davis, R. W., Botstein D. and Roth, J. R. (1980) In Advanced Bacterial Genetics , A manual for genetic engineering. Cold Spring Harbor Laboratory, Cold Spring Harbor, N.Y.) to wild type S. Enteritidis 76Sa88. The cat gene was removed using the plasmid pCP20. The resulting strain was called SM69 (deposit number LMG P-21641). [0096] A ΔguaB mutant of S. Typhimurium strain 1491S96 was constructed using the same procedure and the same primers. The resulting strains S. Typhimurium ΔguaB::catFRT and S. Typhimurium ΔguaB were named SM9 and SM19 respectively. SM86 (having the deposit number LMG P-21646) is the isogenic strain obtained therefrom, after transduction by bacteriophage P22 HT int − lysate from strain SM9 and excision of the cat gene using the plasmid pCP20. [0097] The ΔguaB mutants SM19, SM20, SM86 and SM69 are sensitive to bacteriophage P22. This proves the presence of intact lipopolysaccharides (LPS). [0000] Virulence and Protection Tests with the guaB Deletion Mutant SM20 in Mice [0098] The virulence of the mutant SM20 in mice was tested by oral infection of 6-8 week old female BALB/c mice in two independent experiments. These were performed as described above. The wild type strain S. Enteritidis 76Sa88 was tested in parallel as a positive control. The S. Enteritidis 76Sa88 ΔaroA mutant SM50 was included in the experiment as a vaccine control. This mutant carries a precise deletion of the complete aroA coding sequence and was constructed by the method of Datsenko and Wanner (2000). [0099] The complete data are given in Tables 2 and 3. These results demonstrate that the ΔguaB mutant SM20 is strongly attenuated in mice but still shows some residual pathogenicity when administered at this high dose. Oral immunization with the mutant induces protective immunity against infection by a high dose of the corresponding pathogenic wild type S. Enteritidis strain 76Sa88. The protection is at least equal to the protection conferred by the S. Enteritidis ΔaroA mutant SM50. [0000] Virulence and Protection Tests with the Isogenic guaB Deletion Mutants SM69 and SM86 in Mice [0100] The virulence of the mutants SM69 and SM86 in mice was tested by oral infection of 6-8 week old female BALB/c mice. These were performed as described above. The wild type strains S. Enteritidis 76Sa88 and S. Typhimurium 1491S96 were tested in parallel as positive controls. [0101] The complete data are given in Tables 4-7. These results demonstrate that the ΔguaB mutants SM69 and SM86 are strongly attenuated in mice but still show some residual pathogenicity when administered at this high dose. Oral immunization with the mutants induces protective immunity against infection by a high dose of the corresponding pathogenic wild type strain. [0000] Safety Evaluation of the S. Enteritidis guaB Deletion Mutant SM69 in One-Day-Old Chickens by the Intratracheal and Oral Gavage Routes [0102] The objective of this study was to evaluate the safety of S. Enteritidis ΔguaB mutant strain SM69 master seed in one-day-old chickens. Mortality was used as a primary parameter for the determination of safety. [0103] Chicks at one day of age were leg-banded and randomly placed in each of the four treatment groups (Group 1: SM69-IT, group 2: SM69-OG, group 3: PBS-IT and Group 4: PBS-OG). After the master seed inoculation, the birds from groups 1 and 2 were placed in one isolator and those of groups 3 and 4 in another isolator. [0104] Chickens in groups 1 and 2 were inoculated with the SM69 master seed by the intratracheal (IT) route or oral gavage (OG) route, respectively, with an actual titer of 1.28×10 8 cfu/0.2 ml per bird. Chickens in groups 3 and 4 were administered with 0.2 ml PBS (phosphate buffered saline) per bird by the intratracheal or oral gavage, respectively. [0105] Following the inoculation of SM69 or PBS, chick mortality was observed daily until 38 days post inoculation. Table 8 summarizes the results of mortality for all 4 groups. In group 1, one bird died during the inoculation due to inoculation trauma. Two birds died at 2 days post inoculation (DPI). Three birds died from day 3 to day 13 (at 3, 5 and 13 DPI respectively). A total of 6 birds thus died in group 1. In group 2, two birds died in total. One died during inoculation due to inoculation trauma and one died at day 5 post inoculation. No birds died in the PBS treated groups either by the intratracheal or oral gavage route. [0106] This study indicates that the S. Enteritidis ΔguaB mutant strain SM 69 is not safe when administered at 1.28×10 8 cfu per bird at one day of age by the intratracheal or oral gavage route. [0000] Safety Evaluation of the S. Enteritidis ΔguaB Deletion Mutant SM69 in 2-Week Old Chickens by the Intratracheal and Oral Gavage Routes [0107] Safety of the S. Enteritidis ΔguaB mutant strain SM69 was then evaluated in 2 week-old specific pathogen free (SPF) chickens by the intratracheal and oral gavage routes. Mortality was used as a primary criterion and body weight as a secondary criterion for the determination of safety. [0108] Birds at 2 weeks of age were leg-banded and randomly placed in each of the four treatment groups: SM69-IT, SM69-OG, Poulvac ST-IT and PBS-IT. Ten birds in group 1 were inoculated with SM69 by the intratracheal route; ten birds in group 2 were inoculated with SM69 by oral gavage; ten birds in group 3 were inoculated with a S. Typhimurium AroA − vaccine (Poulvac® ST) by the intratracheal route; and five birds in group 4 were inoculated with PBS by the intratracheal route. [0109] Chickens in groups 1 and 2 were inoculated with SM69 master seed by the intratracheal or oral gavage route, respectively, with the actual titer of 2.304×10 8 cfu/0.2 ml per bird. Chickens in group 3 were administered with Poulvac® ST by the intratracheal route with 2.19×10 8 cfu/0.2 ml per bird. Chickens in group 4 were administered by the intratracheal route with 0.2 ml PBS per bird. [0110] After inoculation, the birds from treatment groups 1 and 2 were placed in one isolator and those from groups 3 and 4 in another isolator. [0111] Following inoculations, mortality was observed daily until 21 days post-inoculation. Body weight of all birds was also recorded at the end of the study period (21 days). Poulvac® ST and PBS were used as intratracheal procedure controls. [0112] During the 21-day observation period, one bird in the SM69 intratracheal treatment group (group 1) died from an infected yolk sac. No mortality was associated with SM69 inoculation, indicating that the SM69 strain is safe at the titer tested, 2.304×10 8 cfu per bird by the intratracheal and oral gavage routes. As expected, no death was observed either in the Poulvac® ST treated birds at the titer of 2.19×10 8 cfu per bird or in the PBS treated birds, indicating that the study was valid (Table 9). [0113] Body weight was compared amongst groups in an analysis of variance (ANOVA) model with body weight as the dependent variable and treatment included as an independent variable. Group comparisons were made using Tukey's test for multiple comparisons. The level of significance was set a p<0.05. The study was considered valid because the control chickens (PBS control group) remained healthy and free of clinical signs of diseases or mortality throughout the study. [0114] There were no significant differences in the final body weight in chickens administered with SM69 by the intratracheal or oral gavage inoculation, Poulvac® ST, or PBS (Table 5). Even though no baseline was established of the birds in each group at one day of age, it was unlikely that there was a significant difference in the initial body weight amongst the four groups since the birds were randomly placed into each of the 4 treatment groups. [0115] Since no mortality was attributable to the inoculation of SM69, it can be concluded that the S. Enteritidis ΔguaB mutant strain, SM69, is safe when administered at the tested titer of 2.304×10 8 cfu/0.2 ml dose per 2-week-old bird, by either the intratracheal or oral gavage inoculation route. SM69 inoculations had no effect on the final body weight of the birds, bird weight being the second safety parameter evaluated here. [0116] A deposit has been made according to the Budapest Treaty at the BCCM/LMG Culture Collection, Laboratorium voor Microbiologie, K.L. Ledeganckstraat 35, B-9000 Gent (Belgium) for the following micro-organisms: Salmonella Enteritidis SM69 under deposit number LMG P-21641 (deposit date: 9 Aug., 2002) and S. Typhimurium SM86 under deposit number LMG P-21646 (deposit date: 28 Aug., 2002). The deposits have been made in the name of Prof. J. -P. Hernalsteens, previous address: Vrije Universiteit Brussel, Laboratorium Genetische Virologie, Paardenstraat 65, B-1640 Sint-Genesius-Rhode, current address: Vrije Universiteit Brussel, Onderzoeksgroep Genetische Virologie, Pleinlaan 2, B-1050 Brussels, Belgium. [0000] TABLE 1 Primer sequences SEQ ID NO Primer Sequence 1 GuaB2 5′ CGTTCAGGCGCAACAGGCCGTTGT 3′ 2 GuaB3 5′ GGCTGCGATTGGCGAGGTAGTA 3′ 3 GuaB4 5′ GGTGATCCCGGGCGTCAAACGTCAGGGCTTCTTTA 3′ 4 GuaB5 5′ TTGACGCCCGGGATCACCAAAGAGTCCCCGAACTA 3′ 5 GuaB6 5′ GCAACAACTCCTGCTGGTTA 3′ 6 GuaB7 5′ AGACCGAGGATCACTTTATC 3′ 7 GuaB10 5′ AGGAAGTTTGAGAGGATAA 3′ 8 P1 5′ GTGTAGGCTGGAGCTGCTTC 3′ 9 P2 5′ CATATGAATATCCTCCTTAG 3′ [0000] TABLE 2 Virulence test in BALB/c mice of the S. Enteritidis guaB deletion mutant SM20 Infection Day of Strain Dose Survival death State of the mice First Experiment negative control: milk / 11/11 / No disease symptoms positive control: S. Enteritidis 76Sa88 2.1 × 10 8 0/5 7, 7, 8, 8, 9 vaccine control: S. Enteritidis ΔaroA SM50 2.5 × 10 8 10/10 / No disease symptoms S. Enteritidis ΔguaB SM20 5.1 × 1O 8  9/10 13 Disease symptoms between the 7 th and the 14 th day after infection Second Experiment negative control: milk / 4/4 / No disease symptoms positive control: S. Enteritidis 76Sa88 1.4 × 10 8 0/3 8, 9, 9 vaccine control: S. Enteritidis ΔaroA SM50 2.1 × 10 8 3/3 / No disease symptoms S. Enteritidis ΔguaB SM20 1.9 × 10 8 3/3 / No disease symptoms [0000] TABLE 3 Challenge of mice vaccinated with the S. Enteritidis guaB deletion mutant SM20 Vaccination Challenge Day of Strain Dose Strain Dose Survival death State of the mice First Experiment negative / negative / 6/6 / No disease symptoms control: milk control: milk negative / S. Enteritidis 1.5 × 10 8 0/5 7, 8, 8, Disease symptoms starting control: milk 76Sa88 8, 9 on the 5 th day after challenge Vaccine 2.5 × 10 8 S. Enteritidis 1.5 × 10 8 3/5 9, 13 Disease symptoms between control: 76Sa88 the 7 th and the 14 th day S. Enteritidis after challenge ΔaroA SM50 S. Enteritidis 5.1 × 10 8 S. Enteritidis 1.5 × 10 8 5/5 / Mice are less active ΔguaB SM20 76Sa88 between the 11 th and the 14 th day after challenge. Second Experiment negative / negative / 2/2 / No disease symptoms control: milk control: milk negative / S. Enteritidis 1.5 × 10 8 0/2 9, 18 control: milk 76Sa88 Vaccine 2.1 × 10 8 S. Enteritidis 1.5 × 10 8 1/3 9, 21 Disease symptoms between control: 76Sa88 the 7 th and the 21 st day S. Enteritidis after challenge. ΔaroA SM50 S. Enteritidis 1.9 × 10 8 S. Enteritidis 1.5 × 10 8 2/3 10 Disease symptoms starting ΔguaB SM20 76Sa88 on the 9 th day after infection. [0000] TABLE 4 Virulence test in BALB/c mice with the isogenic S. Enteritidis guaB deletion mutant SM69 Infection Day of Strain Dose Survival death State of the mice negative control: milk / 4/4 / Asymptomatic positive control: S. Enteritidis 76Sa88 3.7 × 10 8 0/3 7, 8, 9 Severe symptoms onwards from day 5 S. Enteritidis ΔguaB SM69 7.6 × 10 8 5/5 / Mild symptoms, from day 11 till day 18 [0000] TABLE 5 Challenge of mice vaccinated with the S. Enteritidis guaB deletion mutant SM69 Vaccination Challenge Day of Strain Dose Strain Dose Survival death State of the mice negative — S. Enteritidis 3.1 × 10 8 0/4 8, 8, 8, 9 Severe symptoms onwards from control: milk wild type day 5 strain 76Sa88 S. Enteritidis 7.6 × 10 8 S. Enteritidis 3.1 × 10 8 2/5 8, 8, 19 Severe symptoms onwards from ΔguaB SM69 wild type day 5 strain 76Sa88 [0000] TABLE 6 Virulence experiments with S. Typhimurium 1491S96 isogenic mutant strains in BALB/c mice. Oral inoculation with of the mutants of S. Typhimurium strain Infection Strain Day of ( S. Typhimurium 1491S96) Dose Survival death State of the mice First Experiment Wild type SM2 * 0/3 (9, 9, 10) Disease symptoms from day 4 onwards ΔguaB SM86 *   2/5 ** (2, 2, 2) Mild disease symptoms from day 9 until challenge Negative control: milk — 4/4 No symptoms Second Experiment Wild type SM2 0.8 × 10 8 1/4 (11, 13, 14) Disease symptoms from day 6 onwards ΔguaB SM86 0.8 × 10 8 5/5 Weak symptoms on day 13 and 14 Negative control: milk 5/5 No symptoms * inoculated with approximately 10 8 cells (exact titer not determined) ** died after a fight [0000] TABLE 7 Protection experiments with S. Typhimurium isogenic mutant strains in BALB/c mice. Oral inoculation with approximately 10 8 cells of the S. Typhimurium strain 1491S96 Vaccination Strain S. Typhimurium Challenge Day of 1491S96 Dose Strain Dose Survival death State of the mice First Experiment ΔguaB SM86 * S. Typhimurium 1.3 × 10 7 2/2 Mild symptoms until days 14, 1491S96 afterwards one mouse showed clear symptoms, the other was healthy again Negative — S. Typhimurium 1.3 × 10 7 0/4 Severe symptoms from day 6 control: milk 1491S96 onwards Second Experiment ΔguaB SM86 0.8 × 10 8 S. Typhimurium 2.7 × 10 8 5/5 / Reduced activity from day 6 1491S96 till day 16 Negative — S. Typhimurium 2.7 × 10 8 0/5 (8, 9, 10, Severe symptoms from day 6 control: milk 1491S96 11, 16) onwards * inoculated with approximately 10 8 cells (exact titer not determined) [0000] TABLE 8 Safety evaluation of the S. Enteritidis guaB deletion mutant SM69 in one-day-old chickens Infection Strain Group N Titer Route Survival Day of death (DPI) S. Enteritidis SM69 1: SM69-IT 10 1.28 × 10 8 intratracheal  4/10* 0, 2, 3, 5, 13 cfu/0.2 ml S. Enteritidis SM69 2: SM69-OG 10 1.28 × 10 8 oral gavage   8/10** 0, 5 cfu/0.2 ml negative control: 3: PBS-IT 10 PBS - 0.2 ml intratracheal 10/10 — PBS negative control: 4: PBS-OG 10 PBS - 0.2 ml oral gavage 10/10 — PBS IT Intratracheal OG Oral gavage DPI Days post inoculation *In group 1, 1 bird died during inoculation; 1 bird died at 3, 5 and 13 DPI; and 2 birds at 2 DPI respectively **In group 2, 1 bird died during inoculation; and 1 bird died at 5 days DPI [0000] TABLE 9 Safety evaluation of the S. Enteritidis guaB deletion mutant SM69 in 2-week-old chickens Infection Day of Mean weight Std Strain Group N Titer Route Survival death (DPI) (kg) weight S. Enteritidis SM69 1: SM69-IT 10 2.304 × 10 8 IT  9/10* 13 0.429 0.064 cfu/0.2 ml S. Enteritidis SM69 2: SM69-OG 10 2.304 × 10 8 OG 10/10 — 0.420 0.044 cfu/0.2 ml vaccine control: 3: Poulvac- 10 2.19 × 10 8 IT 10/10 — 0.423 0.046 Poulvac ® ST** IT cfu/0.2 ml negative control: 4: PBS-IT 5 PBS - 0.2 ml OG 5/5 — 0.388 0.019 PBS IT Intratracheal OG Oral gavage DPI Days post inoculation *Death due to yolk sac infection **a live S. Typhimurium AroA − vaccine against S. Typhimurium

1a

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This is a continuation of international patent application PCT/GE2007/000003 of Gela Sulaberidze, filed Jul. 2, 2007 and published as WO 2008/146050 A1, which claims priority to Georgia AP 2007 010107, filed Jun. 1, 2007, the disclosures of each being incorporated herein by reference. TECHNICAL FIELD [0002] The invention relates to medicines and concerns the treatment and prevention of metabolic and digestion disorders and of pathological states associated therewith and products used therein. BACKGROUND ART [0003] The World Health Organization and the absolute majority of professional associations have recognized that improper diet, in particular the high calorie content of the diet, the abundance of carbohydrates and fats, and the deficit of dietary fibers, as the main cause of the development and frequency of most non-transmittable diseases, the so-called civilization-accompanying diseases (myocardial infarction, angina pectoris, atherosclerosis, essential hypertension, cholelithiasis, irritable bowels syndrome, obesity, diabetes mellitus, etc.). [0004] During the world history, the origins of diseases, morbidity, and protection against diseases have always been dependent on the mode of life and diet. The same holds true today. The early populations of humans were hunters and collectors and the reason for the most frequent cause of their morbidity was malnutrition due to starvation episodes. In the beginning of the agricultural period, the transition from collecting and hunting to farming and animal husbandry made the episodes of starvation less frequent. However, the less dynamic mode of life resulted in a growth of infectious and parasitic diseases, frequently associated with chronic malnutrition. Nutrient deficiency increased because of the monotonous diet, especially in wintertime. [0005] Infectious diseases were the main causes of morbidity and mortality during most of the periods of human existence. In the last century, especially during the last decades, the rate of infectious and parasitic, or transmittable diseases, has significantly decreased. The decrease can be ascribed to a rise in the level of education, growth of incomes, industrialization, urbanization, and advances in medical and public health care technologies. [0006] Along with this reduction of infectious and parasitic diseases, there has been a dramatically increase in the rate of non-transmittable diseases or medical conditions, which are now some of the leading causes of mortality. These medical conditions include: myocardial infarction; stenocardia, atherosclerosis, essential hypertension, cholelithiasis, irritable bowels syndrome, obesity, diabetes mellitus, etc. These medical conditions are also known as the civilization-associated diseases because their occurrences are closely associated to changes in the mode of life and living conditions. Incidences of civilization-associated diseases are becoming more frequent. It may be assumed that changes in the mode of life and living conditions may be the main causes of the development of these diseases and may be significant factors of pathogenesis. Changes in the mode of life serve as the basis for the formation and progress of civilization-associated diseases that manifest themselves (or are clinically revealed) in later stages of development when their involution is limited or impossible. At that stage an active drug therapy or surgical treatment is required. Treatments at later stages of the disease generally are more expensive, on the one hand, and are frequently associated with complications that frequently are dangerous to life and dramatically affect the standard of living. [0007] Statistically, the major civilization-associated diseases include metabolic disorders and atherosclerosis, which are usually treated surgically (prosthetics of blood vessels, coronary artery bypass grafting, stenting of blood vessels, etc). These treatments are rather costly and the rate of lethality is high. [0008] From 10 to 15 percent of the world population suffers from cholelithiasis and this number is constantly growing. Each decade of the last 50 years the number of people with cholelithiasis has doubled. To treat the disease, cholecystectomy (excise of gallbladder) is being applied more often. However, such treatment is associated with postoperative complications, digestion and metabolic disorders, development of colon cancer, etc. According to various statistics, in 31 to 72 percent of cases, the post-operated gallbladder nevertheless forms gallstones. [0009] The World Health Organization considers obesity to be an epidemic. Weight loss is one of the decisive factors for treatment and management of the most widespread diseases today. Very often obesity is being treated by means of a reconstructive surgery, which is expensive and is frequently associated with complications. [0010] The weight loss may bring forth negative results without reconstructive surgery as well. Investigations performed at 31 weight management centers in the USA demonstrated that in 28 percent of the 1004 patients, who during 16 weeks, for the purpose of weight loss, were given 520 kilocalories/day in the form of liquid proteins, in the absence of preventive measures, their gallbladders nevertheless form gallstones/concrements. [0011] In order to prevent and/or treat diseases, a patient may have to take chemical drugs, for example statins, chemo drugs, and antidiabetic, antianginal, or hypotensive medications as well as other drugs for a long period or his whole life. Such chemical treatments are had at considerable expenses. These preparations have shown side effects and contraindications, due to which their application is limited. Together with the long clinical course their doses increase revealing changes caused by their side effects that further is a separate problem. [0012] Epidemiologic transformation of diseases, in the first place, is connected with nutrition transformation linked with production of foodstuffs, technologies of production, distribution, availability, changes in dietary habits and physical activities (Glob.). [0013] The industrialization during the last 200 years caused the radical changes in food production, transportation, storage and distribution (Glob.). The economic development together with technological innovations and modern capabilities of marketing caused significant changes to the food content. A quantity of easily assimilated refined carbohydrates and saturated fats has increased in a diet while the quantity of dietary fibers has sharply reduced (Glob.). [0014] Popkin (2002) discusses differences of nutrition transformation between the developed and developing countries. He separated a number of common components characterizing the nutrition transformation in the countries of low and average incomes and concluded that those deviations, in the West of 100-200 years ago, will again occur in the developing world of the last decades. [0015] The incursion of the western habits, for example ways of life and commercial marketing, in developing countries furthers a transfer from the traditional foodstuffs to cheap fats and refined carbohydrates, which are readily available thanks to the globalization. Demographic changes caused by the prolongation of life and reduction of birth rate have a greater impact on the risk factors of the diseases become more urgent, of which improper nutrition is the most important (Glob.). [0016] Analysis of the statistical data accumulated in the 20 th century has shown the civilization-associated noncontagious diseases to be most frequent in the countries where the population consumes food rich in calories, refined carbohydrates, and fats, and consumes foods poor in dietary fibers. [0017] Dietary fibers contain non-starch polysaccharides and lignin (Beyul E. A. Class. Med. 1987 No 2). In comparison with starch these polysaccharides are not digested by the digestive enzymes and are utilized by the small and large intestines. For that reason from the early 19 th century and up to the 1960's of the 20 th century dietary fibers were considered an unnecessary component of food and they even were called the ballast substance. The focus shifted to technologies wherein dietary fibers were separated from the plant stock to produce high-calorie, easily assimilated, refined carbohydrates and fats. [0018] This direction had its opponents. In 1861 the German chemist and nutritionist Justus von Liebig wrote that the separation of bran by sieving of the wheat flour was an excess luxury and that bread baked from groats was more wholesome than white bread. The public and scholars of that time viewed such a statement as absurd. Presently, it has been recognized that Liebig was right. [0019] Both experimental and clinical investigations have proved that dietary fibers regulate digestion and metabolism and act as a physiological stimulator of digestive secretion and gastrointestinal motor activity. As a physiological choleretic, dietary fibers normalize intrarectal pressure, improve hepatoenteral cycle of bile acids, bring forth the sense of satiety, prevent the absorption of exogenous cholesterol, and excrete toxins and other waste products. Therefore, to ensure normal digestion and metabolism, food should contain dietary fibers. [0020] Based on the above, one of the leading ways to prevent and treat the most widespread diseases (myocardial infarction, stenocardia, atherosclerosis, essential hypertension, cholelithiasis, irritable bowels syndrome, obesity, diabetes mellitus, etc.) is to use the practical solution to restrict calorie intake, increase consumption of dietary fibers, and increase dietary fiber content in the diet. [0021] Due to the above, it is logical to assume that at present one of the urgent issues of medicine is the prevention and early treatment of the civilization-associated diseases without chemical preparations and surgical interventions. It is commonly accepted that wholesome food and proper nutrition are among the main means for preventing and early treating. Contemporary principles of proper nutrition undoubtedly employ the limitation of calories at the expense of refined fats and carbohydrates and making up for the deficiency of dietary fibers. It has been ascertained that for the purpose of normal functioning of the organism and prevention of the above diseases, healthy adults should take a minimum of 35-40 g of dietary fiber daily. Children should take more than 5 g daily (Marlett J A 2002). At the same time, low-calorie and dietary fiber-rich food is one of the main components in the treatment of these diseases. [0022] Disorders caused by the deficiency of dietary fibers, and the preventive and therapeutic effect based upon making up of this deficit, has repeatedly proved that the statements by Hippocratus said some twenty-five centuries ago, “do not harm” and “food must be a medication and take drug in the form of food” are still true. [0023] For a modern interpretation of the first statement of Hippocratus (“do not harm”) it is necessary to take into account that products rich in dietary fibers are coarse and difficult-to-digest in the unprocessed form. Taking them unprocessed (grain hulls, rinds of fruit and vegetables, berries, etc.) irritates the mucous coat of the stomach, and causes unwanted stimulation of secretion and the motor and evacuation function. Because of the above, the making up of the dietary fibers deficit with unprocessed products containing them in excessive quantities, tablets and granules that contain unprocessed cells is restricted both quantitatively and in time and is, in some cases, even contraindicative. The problem became especially acute in the late 20 th century and the early 21 st century, for the consumption of food prepared by the widespread new technologies. Contemporary man, in comparison with his ancestors, is less adapted to consume such coarse food, and the number of patients for whom coarse food is contraindicated is large. [0024] The perfection of the mechanical and thermal processing of food products (sterilization, manufacturing of refined food, concentrated juices) and the invasion of unnatural substances (preservatives) in cookery have significantly reduced the spread of infectious and parasitic diseases and have extended the shelf-life of food. On the other hand, these technological advances changed the content of the foodstuffs, reduced their beneficial properties, and made them unnatural, which in turn has affected the physiological processes, causing digestive and metabolic disorders. The taking of such unnatural food affects the physiological (natural) protective mechanisms of the human organism, making them unable to regulate digestion and metabolism, which is the basis for development of a number of diseases. [0025] There is a ground cereal product (GE Patent 1205. G. Sulaberidze, B. Rachvelishvili, 17.02.1998) comprised of grain flour and mechanically processed bran. Bread prepared from the ground cereal product is used as a wholesome dietary fiber-rich food. There is an improved method for preparing dough from ground cereal product (GE Patent 2881, G. Sulaberidze, 25.02.03). Bread made of the dough prepared using the method also represents a wholesome dietary fiber-rich food without side effects and contraindications. [0026] From the present state of the art there is no known application of the above ground cereal product and/or finished foodstuff made from it independently or in combination with other foodstuff for the purpose of prevention and treatment of digestion, metabolism and other related diseases. It should, however, be noted that use of the said products for treatment and preventive purposes as the sole foodstuff is inadvisable, for it is connected with the risk of developing a deficiency of proteins, vitamins, microelements. DETAILED DESCRIPTION OF THE INVENTION [0027] The technical effect of the invention is to enhance the therapeutic and preventive effect provided by processed cereal grain products, and to avoid side effects and contraindications. [0028] The subject matter of the invention comprises a method to provide a nutrient combination containing mechanically processed grain bran and meat or dried product selected from the following group: fruit (preferably berries), vegetables, or any combination thereof. [0029] According to the invention, the bran is selected from the following group: wheat bran, rye bran, corn bran, or any combination thereof. [0030] According to the invention, the meat is selected from the following group: beef, chicken, fish, or any combination thereof. [0031] According to the invention, a nutrient combination may comprise dried fruit including apple, peach, apricot, and other fruits. Dried vegetables, including carrot, beet root, and other vegetables may be components of a nutrient combination. Dried berries, including rosehips, cornel, and other berries may be components of the nutrient combination. [0032] In embodiments of the invention, the nutrient combination (e.g, in the form of a muesli or stuffing) contains components at the following ratio, weight %: [0000] Bran 20-80 Meat or dried product 20-80 [0033] According to another embodiment of the invention, the nutrient combination, prepared as a muesli, contains mechanically processed grain bran and dried product selected from the following group: fruit, vegetables, berries, or any combination thereof. Preferably, the dried product is finely minced. [0034] Preferably, the nutrient combination contains components at the following ratio, wt %: [0000] Bran 20-40 Dried product 60-80 [0035] The muesli is prepared by known technology: fruit, vegetables, berries or their combination are dried and minced, following which they are mixed with the dispersed bran. Before feeding to a patient or person desiring a dietary fiber-rich food, water or vinegar solution is poured over the muesli and is mixed to produce a porridge ready for consumption. [0036] In a preferred embodiment of the invention a nutrient combination, having the form of a whole product, is fed to a patient or other person. Such food product will additionally contain water or vinegar solution. The preferred concentration of the vinegar solution is 1-5%. [0037] Preferably, the nutrient combination contains components at the following ratio, wt %: [0000] Muesli 20-40 Water or vinegar essence 60-80 [0038] In another embodiment of the invention, the nutrient combination is incorporated in a whole food product as a stuffing. The whole product is prepared using known food technology in forming a cutlet or kebab, or is used in stuffed cabbage. One may substitute the cutlets, kebabs, or stuffed cabbage with other foods. [0039] According to the invention, the stuffing contains mechanically processed grain bran, meat and water or vinegar solution. The preferred concentration of the vinegar essence is 1-5%. [0040] According to the invention, the stuffing contains meat selected from the following group: beef, chicken, fish, or any combination thereof. Lean beef is the preferable option. [0041] Preferably, the stuffing contains components at the following ratio, wt %: [0000] Bran 4-48 Meat 4-48 Water or vinegar solution the remainder [0042] The method proposed by the invention is intended for the treatment and prevention of the following disorders and pathological conditions: Obesity Diabetes mellitus Irritable bowel syndrome Diverticular disease of colon Constipation Cholelithiasis Hypercholesterolemia Myocardial infarction, stenocardia Essential hypertension Constipation due to pregnancy. [0053] The efficacy of the proposed method has been tested on experimental volunteers. As shown in the Examples, the method proposed by the invention is efficient, safe, practicable and cost-effective. [0054] The invention-proposed porridge and stuffing are prepared according to the technology pattern resembling the process of digestion of dietary fibers by the human organism: mechanical processing (oral cavity), processing in the acid medium (stomach), dilution with liquid (oral cavity, stomach). The proposed method enables one to maintain beneficial properties of the dietary fibers and to prevent alteration of the raw material, contraindications and side effects of the food taken. At the same time, the food/nutrient combination used in the method is low-calorie and enables control of the caloric content. Thus, the proposed method makes it possible that both healthy people and patients consume the dietary fiber-rich food without any restriction. [0055] The proposed method can be widely introduced in the objects of public catering providing a good opportunity to widen the practical limits of making up the deficit of dietary fibers and correspondingly to ensure effective prevention of a whole number of pathologies. At the same time, the food combination applied in the method will ensure in the consumer the sense of satiety due to its quantity and its content of dietary fibers. This, in turn, will enable the consumer, where appropriate, to restrict caloric content without affecting physiological processes. Moreover, the proposed method will further the digestion process and the normalization of metabolism. [0056] Thanks to the proposed method, healthy people and patients will consume dietary fibers in the form of natural products proteins, vitamins, minerals, microelements, in which the raw material used to prepare the food combination is rich in dietary fibers (grain hulls, rinds of fruit and vegetables, berries, etc.). Concurrently, it makes possible that the composition of the combination and its beneficial properties be preserved. [0057] The proposed method enables, where necessary, that both healthy and ill people be fed for a long period with the nutrient food combination of the invention without taking other food, so that no deficit of any necessary nutrient (proteins, fats, carbohydrates, vitamins, minerals, microelements, etc.) be developed. The above is very important in terms of both weight control and the prevention and treatment of diseases. [0058] The proposed method, if regularly applied, will enable the contemporary healthy persons make up for the deficit of dietary fibers so that the organism may control the physiological process and prevent thus many disorders and/or pathologies. EXAMPLES Example 1 [0059] To 50 g muesli containing 20 g wheat bran and 30 g dried apple is added 150 g water and then the combination is mixed to make a porridge to be taken by the patient. Example 2 [0060] To 50 g muesli containing 17.5 g wheat bran, 7.5 g rye bran, 5 g dried apricot, 2.5 g dried beetroot, 2.5 g dried cornel. 2.5 g dried rosehips, and 5 g dried apple is added 75 g of 2% vinegar solution, following which the mass is agitated to make a porridge to be taken by the patient. Example 3 [0061] 260 g of 3%-vinegar solution is poured over 175 g wheat bran and agitated before a uniform mass is obtained. Thereafter, the mass is mixed with 65 g minced meat. The stuffing is used to make kebabs to be taken by the patient. Example 4 [0062] 115 g wheat bran is poured over with 260 g water and agitated before a uniform mass is produced. The obtained mass is mixed with 75 g minced chicken meat and 50 g fish meat. The stuffing is used to make cutlets to be taken by the patient. Example 5 [0063] Patient: male 54 years old, diagnosis: arterial hypertension (II stage JNC7); hypercholesterolemia (BMI—33.4), left ventricular hypertrophy. [0064] Height—178 cm; weight—109 kg. [0065] Arterial hypertension was systematically observed, which normalization was achieved by hypotensive drugs. [0066] Common cholesterol (CHOL)—285 mg/dl (<80) [0067] High density lipoprotein cholesterol (HDL)—37 mg/dl (>45) [0068] Low density lipoprotein cholesterol (LDL)—175 mg/dl (<A30) [0069] Triglycerides (TG)—364 mg/dl (<200) [0070] For 4 weeks the patient received dietary fiber-rich foods (muesli, mince-based food products). [0071] Loss of weight—6 kg [0072] Blood level of lipids was reduced. Common cholesterol (CHOL)—217 mg/dl [0074] High density lipoprotein cholesterol (HDL)—58 mg/dl [0075] Low density lipoprotein cholesterol (LDL)—131 mg/dl [0076] Triglycerides (TG)—139 mg/dl Example 6 [0077] Patient: male 42 years old, diagnosis: diabetes mellitus. Type II [0078] Height—182 cm, weight—113 kg. [0079] Glucose in blood: on an empty stomach 104 mg/dl [0080] After taking of a meal—158 mg/dl [0081] Glycated hemoglobin—7.3% [0082] The patient received during one week the dietary fiber-rich, low-calorie food (gruel, mince-based food products). [0083] Glucose in blood: on an empty stomach 101 mg/dl [0084] After taking meals—131 mg/dl [0085] Glycated hemoglobin—6.2% Example 7 [0086] Patient: female, 28-year old; diagnosis—obesity. [0087] For the purpose of weight correction, during 5 weeks took only the gruel and mince-based food products. No contraindications were noted (irritation of mucous coat, undesirable stimulation of secretion and motor-evacuation function); loss in weight 12 kg. Example 8 [0088] Patient: male, 46-year old; diagnosis: irritable bowel syndrome, constipation. Systematically took purgatives. During one week three times a day received 50 g of muesli-based porridge, i.e. gruel. In two days, a daily free defecation was observed. Example 9 [0089] 24-year old pregnant; on the 12th week of pregnancy constipation was marked; sense of weight in the right side and hypogastrium. According to the ultrasonic examination, bilious sediment was observable in the gallbladder. Against the background of systematic taking of the gruel and the mince-based food products, constipation was arrested. By ultrasonic examination on the 38 th week of pregnancy an increase of the bilious sediment and the formation of calculus were not noted. Example 10 [0090] Patient: female, 35 years old. [0091] Height 174 cm, weight 91 kg; body weight index—32 kg/m 2 . [0092] During 5 weeks for the purpose of weight loss took 520-700 kcal in the form of the dietary fiber-rich food (gruel, mince-based food products). [0093] In two weeks the weight made 86 kg; the body weight index—29 kg/m 2 . [0094] The above examples are for explanation purposes only and do not restrict the scope of protection of the invention. REFERENCES APPEARING IN SPECIFICATION [0000] 1. Glob 2. Popkin 2002 3. Beyul E. A. Class. Med. 1987 No 2 4. Marlett J A 2002 5. GE Patent 1205, G. Sulaberidze, B. Rachvelishvili, Feb. 17, 1998 6. GE Patent 2881, G. Sulaberidze, Feb. 25, 2003

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