Abstract:
Apparatus is disclosed herein which is capable of administering DIAPULSE® treatments, and also capable of applying electromagnetic energy to a treatment area for modified DIAPULSE treatments and for new applications, both thermal and non-thermal, including research. The apparatus provides: more precise control of treatment parameters, including burst repetition rate, power level, and treatment duration, using a minimal number of hardware components; dynamic adjustment of power radiated to a treatment area to a selected power level; the capability of varying treatment parameters in software beyond the variations possible in the earlier DIAPULSE® apparatus; the automatic creation and updating of a patient file which logs treatment parameters and other information, and the ability to access, upload and down load the patient file and information therein; and the reduction of power consumption and power dissipation by and in the improved apparatus. The apparatus includes a power monitor and a processor which cooperate to provide closed loop control of the power of the RF pulses output by the apparatus, and “fail-safe” control of the apparatus to prevent the apparatus from radiating pulses at power levels above a given maximum and upon detection by the apparatus of an abnormal condition.

Description:
COPYRIGHT NOTICE 
     A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent disclosure, as it appears in the Patent and Trademark Office public patent files or records, but otherwise reserves all copyright rights whatsoever. 
     BACKGROUND OF THE INVENTION 
     The invention disclosed herein relates to an apparatus for administering electromagnetic energy to tissue for medical and research purposes. In particular, the present invention relates to such apparatus which administers the electromagnetic energy athermapeutically (non-thermally). Also, the invention relates to a method for providing and updating patient and research files which store information regarding the treatment parameters and the patient or research project. 
     Prior art apparatus for administering high frequency electromagnetic energy athermapeutically has been available for many years from Diapulse Corporation of America, of Great Neck, N.Y. Such apparatus, referred to by Diapulse Corporation of America as the “Diapulse Wound Treatment System”™ (“DWTS”™ ), and referred to herein as “DIAPULSE® apparatus,” has been used extensively for the athermapeutic treatment of damaged tissue, and treatments using such apparatus have come to be identified as “DIAPULSE® treatments” or “DIAPULSE® Therapy”. The following patents relate to earlier DIAPULSE® apparatus, including the treatment head thereof: U.S. Pat. Nos. 2,276,994; 2,276,995; 2,276,996; 3,043,310; 3,181,535; 3,464,010; 3,670,737 and 4,226,246; Canadian Patent No. 679,371; and French Patent No. 2,301,965. The entire disclosures of all of those patents are hereby incorporated herein by reference. 
     DIAPULSE® apparatus available from Diapulse® Corporation of America generates and delivers short bursts of high peak power RF electromagnetic pulses to an area to be treated in or on the patient&#39;s body without causing any significant rise in temperature in the treated area. A DIAPULSE® treatment applies the energy to the desired treatment area by radiating it from a treatment head placed adjacent the treatment area, either in direct contact with or in close proximity to the treatment area. The specific operating parameters of DIAPULSE® treatments are: radiation of RF electromagnetic pulses of 27.12 MHz (11 meter band) in short, squared bursts of 65 μsec., at selectable burst repetition rates between 80 to 600 bursts per second (duty cycle between 0.5% and 3.9%), at selectable peak powers between about 300 and about 1000 watts, providing average powers of from about 1.5 W to about 38 W. Pulse frequencies of 0.5 of 27.12 Mhz and 1.5 of 27.12 Mhz may also be used, i.e. pulse frequencies of 13.56 MHz and 40.68 Mhz, respectively. The treatment head size and the treatment area size are such, that with the parameters given above, the DIAPULSE® treatment is athermapeutic, and the pulsed energy delivered to the treatment area is “non-thermal” in a medical sense. 
     The efficacy of the high amplitude, short duration electromagnetic pulses applied in DIAPULSE® treatments resides in the ability of these pulses to affect the electrical state of living cells, rather than to generate heat. As understood, these high amplitude, short duration electromagnetic pulses achieve beneficial effects by accelerating the return of the electrical state of damaged tissue to its normal condition, thus hastening the resulting electrochemical and chemical responses, and increasing blood flow, which are involved in healing and pain relief. Scientific blind, double blind and control studies have proved that DIAPULSE® treatments accelerate the healing of tissue damaged by burn, laceration, contusion, abrasion and surgical intervention, reduce edema, erythema, and inflammation, and prevent and relieve acute and chronic pain. These studies also show DIAPULSE® treatments to be effective in the treatment of a wide range of specific applications from the treatment of head injuries, pressure ulcers and acute and chronic wounds (due to surgery and otherwise) to the treatment of ankle sprains. See, for example, Ross, Jesse, Utilization of Pulsed High Peak Power Electromagnetic Energy (Diapulse Therapy) to Accelerate Healing Processes, Digest International Symposium, IEEE Antennas and Propagation Society, Stanford University, Jun. 20-22, 1977, pp. 146-149; Ross, Jesse, Results, Theories, and Concepts Concerning the Beneficial Effects of Pulsed High Peak Power Electromagnetic Energy (Diapulse® Therapy) in Accelerating the Inflammatory Process and Wound healing, presented at The Bioelectromagnetics Society 3rd Annual Conference, Washington, D.C., Aug. 9-12, 1981; Ross, Jesse Evolution, Prevention and Relief of Acute and Chronic Pain with the Application of Diapulse® Therapy (Pulse of High Peak Power Electromagnetic Energy), published in Schemerz, 1/1984, pp. 9-16; Ross, Jesse, Biological Effects of pulsed Peak Power Electromagnetic Energy using Diapulse®, published in Emerging Electromagnetic Medicine, O&#39;Connor, M. E., Bentall, R. H. C., Monohan, J. C., editors, Springer-Verlag, 1990, pp. 269-281; Itoh, Masayoshi et al., Accelerating Wound Healing of pressure Ulcers by Pulsed High Peak Power Electromagnetic Energy (Diapulse®), Decubitus, 4(1):24:February 1991; Pennington, Gerard M., et al., Pulsed, Non-Thermal, High Frequency Electromagnetic Energy (Diapulse®) in the Treatment of Grade I and Grade II Ankle Sprains, Military Medicine, Vol. 158, No. 2, February 1993; Sambasivan, M., Pulsed Electromagnetic Field in Management of Head Injuries Neurology India, (1993) 41 (Suppl.), pp. 56-59; Salzberg, Andrew C. et al., The Effects of Non-Thermal Pulsed Electromagnetic Energy (Diapulse®) on Wound Healing of Pressure Ulcers in Spinal Cord-Injured Patients: A Randomized Double-Blind Study, Wounds, Vol. 7, No. 1, January/February 1995, pp. 11-16; Tung, Shirley et al., The Application of Diapulse® in the Treatment of Decubitus Ulcers: Case Reports, Contemporary Surgery, Vol. 47, No. 1, July 1995, pp. 27-32. 
     There is a need, however, for an improved apparatus capable of administering DIAPULSE® treatments, and also capable of applying electromagnetic energy to a treatment area for modified DIAPULSE® treatments and for new applications, both thermal and non-thermal, including research. 
     SUMMARY OF THE INVENTION 
     It is an object of the invention disclosed herein to provide an improved apparatus for the application of electromagnetic energy for medical treatments and/or research. 
     It is another object of the invention to provide such treatment apparatus with improved and/or expanded control of treatment parameters. 
     It is another object of the invention to more precisely control parameters of medical and/or research treatments in an apparatus which delivers high frequency electromagnetic pulses to treatment areas; other objects are to do so using a minimal number of components, and to be able to vary such treatment parameters in software, in response to settings input by a user or in response to settings stored in the apparatus. Another object is to vary the settings stored in the apparatus at the site of the apparatus and/or remotely. 
     It is another object of the invention to control more closely the power output of high frequency electromagnetic pulses radiated by apparatus for conducting medical treatments and/or research. Another object is to provide for “fail-safe” operation in the sense that such apparatus does not radiate the electromagnetic pulses at unsafe power levels, or for time periods sustained for longer than the time periods of the bursts, or when the apparatus is not set to radiate the pulses. 
     It is another object of the invention to automatically store in apparatus for conducting medical treatments and/or research (or apparatus coupled thereto) treatment parameters and other information for each patient or research project and for each treatment session. Another object is to process and/or print these parameters and information either directly from or by the apparatus, or after transfer of the parameters and information to other apparatus or storage devices. Another object is to be able to transfer such information, including information which controls the treatment parameters for a particular patient or treatment session, into and out of such apparatus through a communication link from and/or to a remotely located apparatus. Another object is to provide multi-media capability for such apparatus which includes at least storing and/or displaying of images. 
     It is another object of the invention to provide some indication or alarm (e.g., audio, visual or both, and/or an electronic record), when the treatment head of a medical treatment apparatus is moved out of the position it was initially set in (or a patient moves relative to the treatment head). 
     It is another object of the invention to provide a transportable apparatus for conducting medical treatments and/or research in which treatment parameters may be changeably entered at a given site, and the treatment defined by the entered parameters carried out by the apparatus at another site. 
     It is another object of the invention to reduce power consumption and/or power dissipation in apparatus for generating and delivering bursts of high peak power electromagnetic RF pulses. 
     A more specific object is to improve the prior DIAPULSE® apparatus in one or more, and preferably all, of the following ways, while at the same time retaining the specific operating parameters described above of DIAPULSE® treatments: 
     more precise control of treatment parameters, including burst repetition rate, power level, and treatment duration, using a minimal number of hardware components; 
     dynamic adjustment of power radiated to a treatment area to a selected power level; 
     the capability of varying treatment parameters in software beyond the variations possible in the earlier DIAPULSE® apparatus; 
     the automatic creation and updating of a patient file which logs treatment parameters and other information, and the ability to access, upload and down load the patient file and information therein; 
     the reduction of power consumption and power dissipation by and in the improved apparatus; and 
     provide an entirely “solid-state” apparatus. 
     An improved apparatus for applying electromagnetic energy to a treatment area is disclosed herein which has the capability of maintaining (and does maintain) the specific operating parameters described above of DIAPULSE® treatments, has the capability of regulating these parameters more precisely and/or for safety purposes, and also the capability of changing these parameters for use in DIAPULSE® type treatments and research, and in new or modified treatments and research, both non-thermal and thermal. A method for creating and updating, etc., a patient or research file is also disclosed. The file may be multi-media, e.g., include images and/or sound. 
     When operated in a non-continuous or pulsed manner, as when administering DIAPULSE® treatments, the inventive apparatus generates and radiates bursts of RF electromagnetic energy to a treatment area, with reduced power consumption and dissipation by causing the primary (or major) RF power handling or generating component(s) to be in an off or non-conductive state except substantially during the bursts. According to the invention, power to the primary RF power component(s) is continuously maintained, i.e., the power to the primary RF power component(s) is not pulsed, and the primary RF power component(s) is (are) caused to turn on or conduct substantially only during the bursts. Specifically, the inventive apparatus includes a primary RF power component in the form of one or more RF power amplifiers which output high peak RF power pulses in bursts. According to the invention, power is connected to the RF power amplifier(s) continuously, and the RF power amplifier(s) is (are) biased on for the length of each burst and is (are) biased off substantially at all other times. In the preferred embodiment, two RF power amplifiers are provided connected in parallel, and a power splitter is provided to supply input pulses to the two RF power amplifiers from a common source, e.g., an RF preamplifier, and a power combiner is provided at the outputs of the two RF power amplifiers to combine the pulses output by the RF power amplifiers and provide the combined pulses to a radiating device, e.g., a treatment head. 
     In another embodiment, the primary RF power component(s) may be one or more solid state RF power oscillators which are selectively biased into oscillation during the bursts. 
     In the preferred embodiment, bias is supplied to the RF power amplifier(s) by a bias circuit which may be enabled and disabled by a control signal. In accordance with the invention, the bias circuit is enabled for substantially only the duration of each burst, i.e., are gated into enablement for substantially only the duration of each burst. The bias circuit in the preferred embodiment comprises at least one controllable voltage regulator coupled to supply, when enabled, the bias voltage to the RF power amplifiers(s). 
     In the preferred embodiment, power is supplied to the primary RF power component(s) through a power storage device which stores power between bursts supplied by a power supply, and then releases the stored power to the primary RF power component(s) during the bursts. Thus, the power supply continuously supplies power to the power storage device at a low rate compared to the peak power of the RF pulses. This has the advantage that the power supply may have a continuous power rating which is substantially less than the peak power of the pulses in each burst or series of bursts output by the primary RF power component(s). Also, in the preferred embodiment, pulses to be amplified are not supplied to the primary RF power component(s) except during the time periods of the bursts. In the preferred embodiment, the power supply is a DC power supply and the power storage device(s) comprise one or more capacitors. 
     The inventive apparatus controls the repetition rate of the bursts of pulses in accordance with a burst repetition rate selected by a user, and includes a configurable logic device, coupled to a pulse generator, which comprises a plurality of separately configurable logic elements. The configurable logic device outputs pulses to be amplified during the bursts and outputs signals which control operating parameters, e.g., the burst repetition rate and burst duration. In the preferred embodiment, these signals control the voltage regulator(s) which supplies(y) the bias voltage(s) to the power amplifier(s). The configurable logic device may be configured to support operation of the apparatus for all of these operating parameters without being reconfigured, but can be reconfigured, if desired, to change an operating parameter or parameters. Alternatively, the configurable logic device may be configured to operate in a plurality of modes in which the configurable logic device is reconfigured, preferably dynamically, from mode to mode. In the preferred embodiment, the reconfigurable logic device is dynamically reconfigurable to operate in each of a plurality of modes. In the preferred embodiment, a memory device is provided to store a plurality of configuration files, each file when loaded into the configurable logic device causing the configurable logic elements to be configured to operate in one of the plurality of modes. A controller or processor is coupled to the configurable logic device and the memory device to select the configuration file stored in the memory device to be loaded into the configurable logic device based on a desired burst duration and/or repetition rate which may be input by a user or determined by the apparatus according to a program or dynamically in response to measured or detected parameters. In the preferred embodiment, the burst repetition rate is selected by the user and the burst duration is fixed, but could be made variable, and the configurable logic device is a logic cell array. 
     According to the invention, the controller comprises a system processor or controller and a local processor or controller. The configurable logic device is coupled to the local controller which causes information stored in a memory device coupled to the local controller to be transferred to the configurable logic device to configure or program it. The local controller is directed by the system processor which is preferably that of a computer. In the preferred embodiment, the inventive apparatus includes at least one input device coupled to the system processor for inputting information related to one or more of the parameters of the bursts, including but not limited to the following: the time between bursts (burst repetition rate), the duration of the bursts, a desired peak power level of the pulses in the bursts, and an overall length of time that the bursts are to be supplied. In the preferred embodiment, the burst length is in the order of 65 μsec., and the burst repetition rate is from about 80 bursts per second to about 600 bursts per second (“bps”) (time between bursts of from about 12.5 msec. to about 1.6 msec). 
     The parameters may be set by a user through any suitable input device (e.g., keyboard, mouse and display, touch screen, digitizer). In lieu of or in addition to setting parameters with an input device, the parameters may be stored in memory and set into the apparatus according to a program controlling the processor. The parameters may be input into or changed in the memory by any suitable input device, or by downloading from an apparatus co-located with or located remotely from the inventive apparatus, or dynamically in response to measured, detected or monitored conditions or parameters. 
     Like earlier DIAPULSE® apparatus, the preferred embodiment of the inventive apparatus generates high peak power RF pulses in short bursts for athermapeutic treatment. This apparatus includes an RF pulse generator, an amplifier, and a radiating device coupled to the amplifier for radiating electromagnetic pulses received from the amplifier. 
     According to preferred embodiments of the invention, the inventive apparatus includes a closed loop, real time power adjustment system for automatically adjusting RF electromagnetic power delivered to a load to a desired level. The power adjustment system comprises a power monitor which provides in real time a first (or forward) power level signal related to the forward power level of RF pulses radiated by the radiating device. This signal may be used by itself to regulate the peak power level of the pulses output by the power amplifier(s) to the load, which here comprises the treatment head and the treatment area. The amplifier includes a variable gain stage. A processor or controller which controls the timing of the bursts is coupled to receive at least the first signal, calculate therefrom the forward power level of the RF pulses delivered to the load, and provide a control signal to the amplifier gain control stage which causes the amplifier to adjust the amplitude of RF pulses supplied to the radiating device at or closer to the desired power level in real time, e.g., within the time period between bursts. The apparatus thus can sample and regulate the peak power output by the apparatus, and does not depend upon colormetric measurements to regulate the power output. This real-time power measurement and regulation capability minimizes the time period during which power may be radiated at an unwanted, and perhaps unsafe, level. 
     In the preferred embodiment, the power monitor also provides a second (or reflected) power level signal related to the reflected power level of an RF signal reflected by the load. The processor or controller also receives the second signal, calculates the power reflected from the load and provides the control signal to the variable gain stage in response to both the first signal and the second signal. 
     In the preferred embodiment, the power monitor provides analog first and second power level signals, and the apparatus comprises an analog to digital converter coupled to receive the analog power level signals from the power monitor and provide digital power level signals to the processor, and the processor provides digital signals to the variable gain stage which cause the amplifier to supply RF pulses at the desired power level. In the preferred embodiment, the processor provides the digital signals to a digitally controlled resistance, which controls the gain of the variable gain stage. 
     The power adjustment system may also include a second closed loop for automatically limiting the RF electromagnetic power delivered to the load to a below a maximum level. In the preferred embodiment, the second loop is analog, is not controlled by a processor and is responsive only to the first analog power level signal. This second closed loop includes a circuit which receives the first analog power level signal and prevents the power level of the amplified pulses from exceeding a given maximum value. Also, the system may include a third loop which ensures that the electromagnetic power is not radiated unless the control signal(s) directing same are present. The second and third loops provide the “fail-safe” operation referred to above. 
     In the preferred embodiment, the variable gain amplifier stage comprises one or more solid state devices (e.g., transistors) whose DC supply or bias level is adjusted to adjust the gain thereof. The adjustment may be made by the power monitor system as described above, or in response to data or settings input by a user or stored in the apparatus in software or hardware. An RF transformer is coupled to the output of the solid state device(s) to couple pulses output thereby to a preamplifier or amplifier. The DC supply or bias is supplied to the primary of the RF transformer which supplies the DC to the solid state device(s). In the preferred embodiment, the solid state device is an RF transistor having its collector coupled to the transformer primary and operating in the common base mode. The digitally controlled resistance is coupled to another transistor operating in the common emitter mode with its emitter coupled to the transformer primary, its collector coupled to a source of DC power, and its base coupled to the variable resistance. This arrangement enables the gain of the RF transistor to be controlled with low frequency components. 
     The power adjustment system is used in the preferred embodiments of the invention for the application of DIAPULSE® treatments, but the entire power adjustment system or parts thereof may be used in other applications, both thermal and non-thermal. 
     The invention also provides an indication or alarm when there has been a change by a given amount of the RF energy delivered to the treatment area (detected in the preferred embodiment by a ratio of the forward and reflected power levels at the treatment head). This may be caused by relative movement between the treatment head and the treatment area, i.e., in the case of a patient, either the treatment head or the patient has moved, or other factors. Such movement is manifested by a mismatch in the forward and reflected power levels at the treatment head, which is detected. When the mismatch reaches or passes a given value, an indication is provided by the apparatus, which could be audio, visual or simply an electronic recording of same. The indication may be provided by any conventional audio device, display, indicator, etc. 
     According to the invention, files such as patient or research project files may be automatically generated, updated and maintained in apparatus for applying treatments to a treatment area. Such apparatus may be apparatus of the type disclosed or referred to herein, or other apparatus. The apparatus receives information input by the user, which includes identifying information about the patient or project, and at least one treatment parameter selected by the user. The apparatus measures, monitors, detects, or tracks the at least one treatment parameter while the apparatus is administering the treatment, creates or modifies at least one file based on the identifying information about the patient or project, and stores the identifying information and the at least one treatment parameter in the at least one file. The apparatus may also measure or obtain treatment information and/or at least one treatment attribute, and also store the treatment information or attribute in the file. For example, the treatment information or attribute may be optical data (e.g., scanned photographically, magnetically, electromagnetically, ultra-sonically, etc.) relating to the treatment area, which provides the apparatus with multi-media capability. If desired, sound may also be provided to enhance the apparatus&#39; multi-media capability. The at least one treatment attribute may be obtained while the apparatus is administering the treatment, or before or after the treatment has been administered. The information in the file may be displayed, printed and/or stored, and may be accessed for uploading, down loading and modification by other apparatus, either by direct connection or a communication link. 
    
    
     DESCRIPTION OF THE DRAWINGS 
     The invention is illustrated in the figures of the accompanying drawings which are meant to be exemplary and not limiting, in which like references in different figures refer to like or corresponding parts, and in which: 
     FIG. 1 is block diagram of an improved athermapeutic treatment apparatus in accordance with a preferred embodiment of the invention; 
     FIG. 2 is a block diagram of one of the power amplifiers depicted in FIG.  1  and an embodiment of a gate circuit for turning off the bias to that power amplifier; 
     FIG. 3 is a block diagram of the power monitor of the apparatus of FIG. 1; 
     FIG. 4, consisting of FIGS. 4A,  4 B,  4 C and  4 D, is an schematic diagram, mainly at the integrated circuit level, of a part of the control section of the apparatus of FIG. 1; 
     FIG. 5 is a block diagram of a circuit for cutting off power to the power amplifiers if the apparatus radiates electromagnetic power in the absence of the appropriate control signal; 
     FIGS. 6-8 are screen displays for touch screen inputs of the touch screen of the apparatus of FIG. 1, in which: 
     FIG. 6 is a screen for inputting identifying information about a patient; 
     FIG. 7 is a screen for selecting treatment parameters; and 
     FIG. 8 is a screen displayed while a treatment is in process; and 
     FIG. 9 is a sample patient file record generated by and stored in the apparatus of FIG.  1 . 
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     The preferred embodiments will be described herein with reference to the drawings and the computer program listings contained in the Appendix, which are incorporated into and form part of this specification. 
     Referring to FIG. 1, an improved, computer-controlled DIAPULTSE® treatment apparatus  10  of the type described above generates and radiates from a treatment head  16  short bursts of high frequency, high power electromagnetic pulses at a frequency of 27.12 MHz., although the apparatus may generate and radiate at other frequencies if desired. A crystal oscillator  12  generates a 27.12 MHz. square wave clock signal which is used both as a timing signal and as the source of the RF pulses radiated by the treatment head  16  after amplification by an RF amplifier  14 . The apparatus  10  is controlled by a control section  18  which includes a processor  20  and memory  22 . A crystal oscillator associated with the processor  20  functions as the system clock. In the preferred embodiment, the processor  20  is a 486 or higher model microprocessor available from Intel Corporation. However, other processors available from Intel and other sources may be used. 
     As shown in FIG. 1, the clock signal from the oscillator  12  is fed into a configurable logic device  24 , described below, which outputs the 27.12 MHz clock pulses to the amplifier  14  in short bursts, at a burst repetition rate selected by the user. In the preferred embodiment, the configurable logic device is a Xilinx XC2018 logic cell array (“LCA”). Other suitable configurable logic devices may be used, both those that are configured once for operation with all system parameters and those that are dynamically reconfigurable for system operation in modes as described herein. Such other devices will be apparent to those having skill in the art from the disclosure herein. The bursts of RF pulses are amplified by the amplifier  14  to a desired amplitude and delivered to the treatment head  16  via an RF coaxial cable  41  and a power monitor  26 . The treatment head  16  radiates electromagnetic pulses at a peak RF power level selected by the user to an area of a patient to be treated. As mentioned above, the RF load comprises the treatment head  16  and the patient. Since the impedance of patients varies from patient-to-patient and in different parts of a patient&#39;s body, and since the treatment head  16  may be positioned differently for any patient or treatment area, the amount of RF power reflected back from the treatment head  16  due to a mismatch between the RF power amplifiers  36 A, B and the RF load may vary from treatment to treatment. To compensate for this, an adjustable tuned circuit (not shown) is provided in the treatment head  16 . Further compensation for this and/or to tune different lengths of a coaxial cable  41  coupling the amplifier  14  to the treatment head  16  another adjustable tuned circuit (not shown) may be provided at the apparatus side of the coaxial cable. 
     In accordance with the invention, the apparatus  10  additionally includes a closed loop, real-time power adjustment system, described below, which adjusts the power radiated to the patient in response to: both the forward and reflected power levels described above, and also in response only to the forward power level. The power adjustment system measures, or detects, in the power monitor  26  (FIG. 1) the level of RF (forward) power delivered to the treatment head  16  (which is representative of the RF power radiated to the patient) and the level of RF power reflected at the treatment head  16 , and supplies this information to the control section  18  which then adjusts the gain of amplifier  14  to thereby adjust the forward RF power level. 
     The power adjustment system includes three closed control loops, one including the processor  20  and the other two bypassing the processor  20 . As shown in FIG. 1, in one loop, the processor  20  receives the forward and reflected power levels detected by the power monitor  26 . As described below, processor  20  computes the actual power delivered to the treatment head  16 , and determines a revised amplitude of the RF pulses to be radiated which would provide an actual RF power at or closer to the power level selected by the user. The processor  20  provides revised signals to the amplifier  14  to essentially continuously adjust the amplitude of the pulses in real time. The processor  20  controls the duration of the treatment and the burst repetition rate (duty cycle) of the RF pulse bursts, and controls the amplifier  14  to set the amplitude of the RF pulses delivered to the treatment head  16  to achieve peak adjustable RF power levels of from less than about 300 watts to about 1000 watts or more, and average power levels of from less than about 1.5 W to about 38 W or more, all as selected by the user who may be a doctor, nurse, therapist, medical professional, etc., or even the patient him or herself. The apparatus  10  has the capability of providing peak powers of less than about 300 W and more than about 1000 W and average powers of less than about 1.5 W and more than about 38 W, primarily or exclusively under software control, except that where higher peak and average powers are desired, it may also be necessary to provide higher power hardware components. 
     In another loop (not shown in FIG.  1  and described below with reference to FIG.  4 ), the forward detected RF power level signal from the power monitor  26  is fed to a circuit  27  which is a fail-safe circuit that prevents the pulses output by the amplifier  14  from exceeding a maximum amplitude value in the event that the forward power exceeds a predetermined safety threshold. This eliminates any danger to the patient should the burst length, burst repetition rate and/or pulse amplitude change. 
     The RF amplifier  14  includes an RF preamplifier  34  and RF power amplifiers  36 A and  36 B. Power for the RF preamplifier  34  (FIG. 1) is supplied by a DC power supply  66  and an associated power storage device  67 . In a third loop shown in FIG. 1, the forward detected RF power signal from the power monitor  26  is fed to a circuit  27 A (shown schematically in FIG. 5) which cuts off the power from the power supply  66  if a given level of forward power is detected in the absence of a control signal (line  86 A, or line  86 B in FIG.  4 ). Circuit  27 A is another fail-safe circuit which ensures that the apparatus  10  does not radiate power unless the apparatus  10  generates the appropriate control signal. 
     Power for the RF power amplifiers  36 A and  36 B (FIG. 1) is supplied by a DC power supply  28  and an associated power storage device  29 . The DC power supply  28  has a continuous power rating significantly less than the peak power of the radiated pulses. The continuous rating of the power supply  28  depends upon the peak power and the average power of the radiated pulses. For example, for a maximum peak power of about 1000 w and a maximum average power of about 38 watts, the continuous power rating of power supply  28  may be only 38 watts, plus any losses and a safety factor, which in the case of amplifiers  36 A,  36 B is in the order of 50%. In the preferred embodiment where the maximum peak power is about 1000 W and average power is about 38 W, the power supply  28  has a continuous rating of 100 W and the power storage device  29  comprises 10,000 μf of capacitance connected across the output of the power supply  28 . The fail-safe circuit  27  (FIG. 4) also eliminates the risk that the peak power will be sustained. 
     The three-loop system described above provides for precise, computerized, fail-safe control over the power radiated by the apparatus, thus improving the quality and safety of the treatments. 
     The amplifier  14  (FIG. 1) also includes a variable gain stage  32 , whose gain is controlled by the first loop discussed above, in addition to the preamplifier stage  34  and the power amplifiers  36 A and  36 B. The power amplifiers  36 A and  36 B are turned on only a short time before each burst is generated and during each burst, and are turned off all other times. The configurable logic device  24  provides a signal to control the timing of the turn-on of the power amplifiers  36 A and  36 B, and also passes RF clock pulses to the variable gain stage  32  of the amplifier  14  during the short burst periods. Turning off the amplifiers  36 A and  36 B during most of the time between bursts and not supplying RF clock pulses to the amplifier  14  between bursts reduce power consumption and dissipation in the amplifier  14 , and allow the use of components with lower continuous ratings. The output of the preamplifier  34  is split in a power splitter  38 , and the outputs of the power amplifiers  36 A and  36 B are combined in a power combiner  40 . The output of the power combiner  40  is supplied to the treatment head  16  through the power monitor  26  and the coaxial cable  41 . 
     Apparatus  10  may also be operated in an open loop mode, i.e., without any power adjustment responsive to signals from the power monitor  26 . During open loop operation, information regarding power levels provided by the power monitor  26  may simply be ignored. However, it is preferred that apparatus  10  not be operated without the closed loop fail-safe circuits  27  (FIG. 4) and  27 A (FIGS.  1  and  5 ). 
     The configurable logic device  24  (FIG. 1 ) can be configured to provide timing for a number of different burst repetition rates. A configuration memory  46  stores configuration files which are selectively loaded into the configurable logic device  24  via a local controller  48  to configure the logic device  24  to provide the timing for different burst repetition rates. The use of a dynamically reconfigurable logic device  24  to control the burst repetition rate allows software configuration thereof without the need to replace or provide additional hardware components. The frequency of the RF pulses output by the treatment head  16  and the length of the pulse bursts may also be adjusted through software configuration of the configurable logic device  24 . Frequencies higher than 27.12 MHz, require a higher frequency clock oscillator  12  (or a frequency doubler, etc.), with the configurable logic device  24  being configured to provide lower frequency clock signals as needed. Thus, the improved DIAPULSE® apparatus  10  is fully adjustable by software within given ranges imposed by certain hardware components. Outside these ranges, the apparatus  10  is still adjustable in software but also may require different or additional hardware components. For example, the apparatus  10 , via the configurable logic device  24  (and memory and a processor), has the capability of adjusting the duration of bursts and the burst repetition rate from a single cycle and a single bps, respectively, up to continuous wave which, however, would require replacement of some hardware components in order to operate at the higher average power levels of longer bursts and higher burst repetition rates. 
     The apparatus communicates information to the user through a video display screen  56  (FIG. 1) (e.g., an LCD flat panel display) and the user enters patient data and treatment parameters through a touch screen  58 , e.g. an IR touch screen available from Carrol Touch Screen or a resistive touch screen available from Elographics Inc.. Other types of displays and input devices may be used, such as a conventional CRT monitor and a keyboard, mouse, or electronic stylus and digitizer. 
     Information entered by the user, as well as actual treatment data including the time duration of the treatment, are stored in memory  22  (FIG. 1) in an automatically generated and updated patient file. The patient file is stored on a hard disk (or in another memory device) and retrieved in later treatment sessions with the same patient so that the user can selectively utilize the same treatment parameters or adjust the parameters based on the effects of the previous treatment. The patient file of the apparatus  10  may be uploaded to and/or downloaded from and/or modified by another source, and may be printed from a printer coupled directly to the apparatus  10 , or elsewhere. The other source may be remotely located and linked by a communication link such as telephone lines, as will be described below. 
     The DC power supply 66 (FIG. 1) in the preferred embodiment is 24 v, and the associated power storage device  67 , comprises 10,000 μf of capacitance connected across the output of the power supply  66 . The power supply  66  supplies DC to the preamplifier  34  and a cooling fan (not shown). The DC power supply  28  which supplies power to the power amplifiers  36 A and  36 B in the preferred embodiment is 48 v. A third power supply  70  supplies DC to circuits in control section  18 . 
     All of the components of apparatus  10  may be housed together as a stand alone unit. Alternatively, all or parts of apparatus  10  may be housed within a commercially available computer e.g., a desk top computer such as a personal computer, and integrated with the computer. For example, all or some of the circuits of apparatus  10  may be installed in one or more printed circuit boards which are mounted in the computer. The processor  20 , memory  22  and the power supply  70  may be embodied in the commercially available computer, which may be housed as described above. In the preferred embodiment, the oscillator  12 , the configurable logic device  24 , the controller  48  and the configuration memory  45 , as well as the variable gain amplifier stage  32  and the fail safe circuit  27 , are all contained on a single printed circuit board, and comprise the components shown in FIG.  4 . The fail safe circuit  27 A may also be contained on that board. The other components shown in FIG. 1 are not contained on that board. 
     Referring to FIG. 1, bursts of RF pulses from the configurable logic device  24  are fed into the variable gain amplifier stage  32 , which receives gain control signals from the control section  18 , as will be described in detail below with reference to FIG.  4 . The output from the variable gain amplifier stage  32  is fed into preamplifier  34  having a nominal power gain of 40 dB and capable of developing 20 watts of RF power. The preamplifier  34  may be conventional. The preferred embodiment of the preamplifier  34  is described in literature published by Motorola, and includes a Motorola MHW59 hybrid module driving a pair of MRF426 power transistors. However, other preamplifiers apparent to those of skill in the art may be used. 
     The output from the preamplifier  34  is fed into power splitter  38  (FIG.  1 ), which in the preferred embodiment is conventional, e.g., a ferro-magnetic device having a nominal input and output impedance of 50 ohms. The power splitter  38  divides the power level of the incoming pulses in half, sending half to each of two identical power amplifiers  36 A and  36 B connected in parallel, which may be conventional. The preferred embodiment of power amplifiers  36 A and  36 B is described in literature published by Motorola, and each amplifier  36 A,  36 B includes a push-pull circuit  76  (FIG. 2) employing four MRF150 RF power FETs. Other power amplifiers apparent to those of skill in the art may be employed. Each amplifier  36 A,  36 B has a gain of 20 dB and can produce RF pulses of up to 600 W peak power. The power amplifiers  36 A and  36 B are used in a hybrid parallel configuration to obtain a combined peak output power of up to 1200 W at the output of the power combiner  40 . 
     In the preferred embodiment described herein, the preamplifier  34  and power amplifier  36 A,  36 B provide up to 1000 W peak power output and up to 38 W average power. However, as pointed out above, other preamplifiers and amplifiers may be provided for substantially higher or substantially lower peak and average power outputs for use in other applications, both non-thermal and thermal. 
     Referring to FIG. 2, which shows only one power amplifier  36 A (power amplifier  36 B is the same), the RF pulses output by the preamplifier  34  are supplied to the push-pull circuit  76  which outputs amplified RF to the power combiner  40 . The power for amplifying the pulses in amplifier  36 A is supplied by power supply  28  and power storage device  29 , which are coupled to the push-pull circuit  76  of both amplifiers  36 A and  36 B. The push-pull circuit  76  also receives a bias voltage from a voltage regulator  80  (part of the bias circuit) that in cooperation with circuitry in amplifier  36 A either provides a bias voltage to the push-pull circuit  76  or does not. The voltage regulator  80  receives DC power from power supply  28  and power storage device  29 , and provides or does not provide a more regulated, lower DC bias voltage to the push-pull circuit  76 , and a bias control signal on a control input  82  which enables and disables the voltage regulator. The logic level of the signal on control input  82  determines whether the voltage regulator  80  is enabled or disabled, and whether it provides a bias voltage to the push pull circuit  76 . Specifically, in the preferred embodiment, a logic one signal on the control input  82  enables the voltage regulator  80 , and a logic zero disables it. A transistor  84  coupled between the control input  82  and line  86 A from the configurable logic device  24  functions as an inverter. Thus, a logical zero signal from the logic device  24  on line  86 A enables the voltage regulator  80  to cause it to provide a bias voltage which either causes or allows the power amplifier  36 A to conduct, and a logical one signal from the logic device  24  on line  86 A disables the voltage regulator to cause it to turn the power amplifier  36 A off. Since power amplifier  36 A is biased off except for the short burst periods, the signal on line  86 A to turn amplifier  36 A on is a short negative going pulse, which is inverted by transistor  84  to a short positive-going pulse, as shown schematically in FIG.  2 . 
     Stated another way, configurable logic device  24  (FIG. 4) provides a gate signal on line  86 A to gate voltage regulator  80  on for the burst periods and a short time therebefore. In this embodiment, the configurable logic device  24  provides a 75 μs negative-going pulse as the on gating signal on lines  86 A and  86 B (FIG. 1) at a selected burst repetition rate of between 80 to 600 bps. The amplifiers  36 A and  36 B are gated on for this short period of time and are off at all other times. For 75 μsec. on-times, at burst repetition rates of from 80 to 600 bps, the on duty cycle for the power amplifiers  36 A and  36 B is very low—from about 0.6% to about 4.5%. However, the actual duty cycle is that of the 65 μsec. bursts when the amplifiers  36 A and  36 B are on and amplifying pulses output by the preamplifier  34  to provide the high peak power pulses, which is from 0.5% to about 3.9%. With such low duty cycles, the power amplifiers  36 A and  36 B may be operated far in excess of their continuous power ratings, with little or no power being consumed when the power amplifiers  36 A and  36 B are off and in the 10 μsec. before each burst. At the highest on duty cycle of 3.9%, the average power needed to deliver bursts of radiated RF electromagnetic pulse power of 1 kW is about 38 W. Accordingly, the present invention provides the ability to use a power supply  28  as small as 38 W (plus losses and a safety factor) to deliver short, high peak power, non-thermal bursts of RF electromagnetic pulses. However, to provide for losses and to provide a safety factor, a 100 W power supply  28  is used. 
     As one skilled in the art will recognize, one power amplifier with twice the capacity of the two amplifiers  36 A and  36 B may be used in place of the two amplifiers. In that case, only one control line  86  from the configurable logic device  24  is required, and the power splitter  38  and power combiner  40  are not required and may be omitted from the circuit. 
     The amplified RF pulses from power amplifiers  36 A and  36 B (FIG.  1 ), combined in power combiner  40 , are fed via a coaxial cable past the power monitor  26  to the treatment head  16 . The power monitor  26  forms part of the three closed control loops described above for controlling the level of power output by apparatus  10 . 
     Referring to FIG. 3, the power monitor  26  comprises a current transformer  94 . a voltage transformer  96 , and two identical video detector circuits  98 A and  98 B, one of which, detector  98 A, serves as a forward power detector, and the other, detector  98 B, serves as a reflected power detector. The power monitor may also be considered to include an analog-to-digital converter  112 , as described below. A short length of conductor  100  in an RG-8/M coaxial cable from the power combiner  44  to the treatment head  16  is exposed and serves as the primary winding of current transformer  94 . Current transformer  94  induces an AC current in its secondary  95 A,  95 B proportional to the RF current in conductor  100 . Voltage transformer  96  generates an AC potential at each of two independent single turn secondaries  104 A and  104 B. These generate an AC potential proportional to the current in conductor  100  across respective parallel RC circuits, composed of resistors  102 A,  102 B and capacitors  103 A,  103 B, which act as terminating impedances. As discussed above, the treatment head  16  and the patient constitute a load to the amplifier  14 . For a resistive load presented to the amplifier  14  equal to 50 ohms (the RF pulse impedance), the AC potentials across resistor  102 A and capacitor  103 A at the input to forward power detector  98 A are in phase and are additive, while the AC potentials across resistor  102 B and capacitor  103 B at the input to the reflected power detector  98 B are out of phase and are thus subtractive. For a load with a reactive component or a resistance not equal to 50 ohms, the magnitude of the AC potentials at the forward and reflected detectors  98 A and  98 B are vectorial summations of components thereof. 
     The AC signals provided by the transformers  94 ,  96  (FIG. 3) are rectified by video detectors  98 A and  98 B comprised respectively of diodes  106 A and  106 B, filter capacitors  107 A and  107 B, and resistors  108 A, B and  109 A, B. The values of these components are selected so that the outputs of the video detectors  98 A and  98 B are fast varying analog power level signals related to the phase angles and magnitudes of the forward and reflected RF pulses, respectively. A similar power detector is described in U.S. Pat. No. 5,424,691, the entire disclosure of which is incorporated herein by reference. The power monitor  26  is available from Tandy Corporation. 
     Referring to FIG. 4, in which all of the components shown therein are mounted to the printed circuit board described above, the analog power level signals output by the power monitor  26  are received on the printed circuit board through pins  1  and  3  of connector  110 , and supplied to an analog-to-digital converter (“A/D”)  112  through a multiplexer (MUX)  114 . A/D  112  supplies digital power level signals to the controller  48  corresponding to the value of the analog power level signals. These digital power level values are provided to the processor  20  which processes the power level values to compute a value for the actual power delivered to the load, which is the forward power value minus the reflected power value. This forms part of the first closed loop described above for the real time control of the power output by the apparatus  10 . (A/D 112  may be considered part of the power monitor when converting analog power level signals to digital power level signals.) This actual power value is used to raise or lower the amplitude of the RF pulses output by the power amplifiers  36 A and  36 B so that the actual power level is closer or equal to the desired power level, as selected by a user. Because the detectors  98 A and  98 B are video detectors, the forward and reflected power levels are measured in real-time, and changes in the forward and reflected power levels can be detected, and appropriate changes to the RF pulse amplitude can be made, in the time period between the bursts of RF pulses. Thus, power regulation is essentially instantaneous, occurring in the preferred embodiment within from about 1.6 msec to about 12.5 msec (the time between bursts). 
     The processor  20  also compares the actual power value (forward to reflected power ratio) to a preset value, and when the actual power value reaches or passes (equals or falls below) the preset value, the processor outputs a signal to alarm  123  to activate it. Alarm  123  remains activated as long as the actual power value is less than or equal to the preset value. When the actual power value again exceeds the preset value, the processor  20  terminates the signal to the alarm  123 , which then turns off. Alarm  123  may be any conventional audio device, indicator device, video device or display. A change in the ratio may be caused by movement of the treatment head relative to the treatment area, or by other factors. The indication or alarm notifies the patent or attendant of such movement, and the need for readjustment. If desired, the occurrence of an alarm signal may be stored to indicate a change in the power delivered to the treatment area, or for other reasons. 
     Referring to FIG. 1, the processor  20  supplies signals to controller  48  which in turn supplies signals to the variable gain amplifier stage  32  to adjust the amplitude of the RF pulses output by the power amplifiers  36 A and  36 B, which cause the variable gain amplifier stage  32  to either raise or lower the forward power level by the value of the reflected power, or, as in the preferred embodiment, which adjust the forward power level using conventional PID (proportional, integral, derivative) algorithms, well known in the art, to bring the actual power level closer to the desired power level more slowly to avoid a succession of back and forth adjustments and overshoots. 
     Referring to FIG. 4, the variable gain amplifier stage  32  includes an RF amplifier  124  coupled to receive the RF pulses from the configurable logic device  24 , an RF transformer  125  coupled between the RF amplifier  124  and the input of the preamplifier  34  (FIG. 1) via connector  110  (FIG.  4 ), and a variable level DC circuit  126  for supplying a level of DC to the RF amplifier  124  via the primary of transformer  125  corresponding to the gain desired of the RF amplifier  124 . The higher the DC level, the higher the output of the RF amplifier  124 . The RF amplifier  124  comprises a transistor  128  having its collector coupled to the primary of transformer  125 , its base coupled to receive RF clock pulses from the configurable logic device  24  through a high pass filter  130 , and its emitter connected to ground through a resistor. RF pulses amplified at the collector of transistor  128  are supplied to the preamplifier  34  via connector  110 . The DC level of the collector of transistor  128  determines its gain, which is set by a transistor  132  as controlled by a DS1267 digitally controlled, dual potentiometer  134 , available from Dallas Semiconductor. The dual potentiometer  134  receives serial digital signals from the processor  20  (not shown in FIG. 4) via the controller  48  over the SDATA line into a data-in pin DI, which set the resistance values of the two potentiometers. The two potentiometers in the dual potentiometer  134  are connected in series between Vcc and ground, to provide a variable resistance to the base of transistor  132 , as follows. The high end H 1  of one potentiometer is connected to Vcc through a resistance. The wiper W 1  of the one potentiometer is connected to its low end L 1 , which is connected to the high end HO of the other potentiometer. The low end LO of the other potentiometer is connected to ground through a diode. The wiper WO of the other potentiometer is connected to the base of transistor  132 . The resistance value set in dual potentiometer  134  between the high end H 1  of the first potentiometer and the wiper WO of the second potentiometer determines the DC voltage at the base of transistor  132 , with the lower the setting of this resistance the lower the voltage value at the base of transistor  132 . The high pass filter  130 , transistor  128  and transformer  125  convert the square wave RF clock pulses output by variable gain stage  124  into a sinusoidal signal which is then input to the preamplifier  34  (FIG. 1) off the printed circuit board via connector  110  (FIG.  4 ). 
     The variable gain amplifier stage  32  (FIG. 4) just described provides the ability to digitally control the amplitude of the high frequency RF pulses output by the power amplifiers  36 A and  36 B using low frequency components so that the treatment head  16  delivers RF pulses of a desired magnitude as selected by the user. In the preferred embodiment, the user has six possible peak power settings, each at six possible burst repetition rates, as shown in the screen display of FIG. 7, although many more can be provided if desired. These settings provide six levels of peak power and 36 levels of average power, as shown in Table 1 below. The actual power levels may differ from those listed in Table 1, and the actual power levels for open loop operation may be different from those in closed loop operation. Known calibration techniques may be employed to obtain the actual power levels. 
     
       
         
               
               
             
               
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
               
             
           
               
                 TABLE 1 
               
             
             
               
                   
               
               
                      Power 
                 Burst Repetition Rate 
               
             
          
           
               
                      Setting 
                                 600 
                 500 
                 400 
                 300 
                 160 
                 80 
               
               
                   
               
             
          
           
               
                        6 
                 975 
                 975 
                 975 
                 975 
                 975 
                 975 
                 Pk. Pwr. 
               
               
                   
                 38 
                 31.6 
                 25.3 
                 19 
                 10.1 
                 5.07 
                 Av. Pwr. 
               
               
                 5 
                 780 
                 780 
                 780 
                 780 
                 780 
                 780 
                 Pk. Pwr. 
               
               
                   
                 30.4 
                 25.3 
                 20.3 
                 16.2 
                 9.1 
                 4.06 
                 Av. Pwr. 
               
               
                 4 
                 585 
                 585 
                 585 
                 585 
                 585 
                 585 
                 Pk. Pwr. 
               
               
                   
                 22.8 
                 19 
                 15.2 
                 11.4 
                 6.08 
                 3.04 
                 Av. Pwr. 
               
               
                 3 
                 488 
                 488 
                 488 
                 488 
                 488 
                 488 
                 Pk. Pwr. 
               
               
                   
                 19 
                 15.85 
                 12.68 
                 9.5 
                 5.07 
                 2.53 
                 Av. Pwr. 
               
               
                 2 
                 390 
                 390 
                 390 
                 390 
                 390 
                 390 
                 Pk. Pwr. 
               
               
                   
                 15.2 
                 12.65 
                 10.14 
                 7.6 
                 4.05 
                 2.03 
                 Ag. Pwr. 
               
               
                 1 
                 293 
                 293 
                 293 
                 293 
                 293 
                 293 
                 Pk. Pwr. 
               
               
                   
                 11.4 
                 9.5 
                 7.6 
                 5.7 
                 3.04 
                 1.52 
                 Av. Pwr. 
               
               
                   
               
             
          
         
       
     
     The forward power level signal from the power monitor  26  is supplied both to the A/D 112  and to the fail-safe circuit  27  (FIG.  4 ), which also controls the gain of the variable gain amplifier stage  32  when the actual power delivered reaches a predetermined safety threshold. The fail-safe circuit  27  forms part of the second closed control loop, and comprises a transistor  140  with its collector connected to the base of transistor  132 , its emitter connected to ground, and its base connected to a diode  142 , resistors  143  and  144 , and capacitor  145 . During normal system operation, i.e., when bursts are no longer than the se burst length (e.g. 65 μs), the voltage at the base of transistor  140  will be about 0.3 V, which is not enough to turn it on. However, if the RF pulses exceed the set burst length by a predetermined threshold, or if the burst repetition rate increases, or the bursts become continuous, the base voltage at the transistor  140  will increase to turn transistor  140  on. This has the same effect as the potentiometer  134  lowering the voltage to the base of transistor  132 , except that transistor  140  eventually will somewhat abruptly turn on fully to ground the base of transistor  132 , which turns transistor  132  off so that no DC component is supplied at the transformer  125 . With no DC component supplied to transistor  128 , it does not pass the RF pulses supplied by the configurable logic device  24  so that no RF input is provided to preamplifier  34 . Thus, the power amplifiers  36 A and  36 B will output pulses of varying magnitude between zero and a maximum value as controlled by the fail safe circuit  27 , eliminating the risk of harm to the patient and to system components as the result of increased forward power due to certain failures in apparatus  10 . 
     Another safety circuit  27 A (FIG.  1 ), which forms part of the third closed control loop, acts to cut off the DC voltage to the preamplifier  34  if the power monitor  26  detects a given level of forward power (detector  98 A in FIG. 3) in the absence of the gate signal on lines  86 A,  86 B (FIG. 4) from configurable logic device  24 . Thus, if apparatus  10  is providing high power pulses to the treatment head  16  when it shouldn&#39;t be, circuit  27 A cuts off the DC voltage to the preamplifier  34 . Referring to FIG. 5, the DC voltage from the power storage device  67  is supplied to a voltage regulator  80 A from which the DC voltage is supplied to the preamplifier  34 . As for the voltage regulator  80  in FIG. 2, a logic level one provided on the control input  82 A of voltage regulator  80 A enables the voltage regulator  80 A and allows it to output a DC voltage to the preamplifier  34 , and a logic level zero disables the voltage regulator  80 A so it does not output a DC voltage. The conditions for providing a logic level zero on input  82 A are the presence of a logic level one from the forward power detector  98 A and the absence of the gate signal on line  86 A or B. AND gate  147  logically and&#39;s these conditions, and when they are both present, provides a logic level one to transistor  84 A to turn it on and ground the control input  82 A to the voltage regulator  80 A. When these conditions are not present, the output of AND gate  147  is a logic level zero, transistor  84 A is off, and the voltage level at control input  82 A is a logic level one, as provided by the voltage division of resistors  148  and  149 . 
     FIG. 4 also shows the circuitry for outputting the RF pulse bursts at the desired repetition rate and for controlling the touch screen interface and the timing of the A/D  112 . This circuitry includes the local controller  48  programmed to carry out tasks requested by the processor  20 , memory  46  in the form of an EPROM, a latch  150 , the MUX  114 , and filters and scaling circuitry for pulse and touch screen monitoring, and touch screen connector  154 . 
     Still referring to FIG. 4, the controller  48  in the preferred embodiment is an Intel 8031 microcontroller, programmed to, among other things, control data transfers between the processor  20  and components shown in FIG. 4, and to control the configuration of the configurable logic device  24  by selecting one of the configuration files stored in the memory  46  to be loaded into the configurable logic device  24 . The programming for the Intel 8031 microcontroller  48  is contained in the Appendix. The configurable logic device  24  receives signals from the crystal oscillator  12  at the XTL 1  and XTL 2  inputs. An oscillator (not shown) associated with the processor  20  on a motherboard of a desk top computer functions as the system clock. The configurable logic device  24  passes the RF pulses to the variable gain amplifier  32  in 65 μs bursts at the selected burst repetition rate by counting down the 27.12 MHz. clock. 
     As shown in the screen display of FIG. 6, and in Table 1, the user can select from six possible burst repetition rates (labeled “frequency” in the FIG. 6 screen display). Referring to FIG. 4, for each burst repetition rate, the configurable logic device  24  is configured to count down different times between pulses. The controller  48  selects the appropriate configuration file to be loaded into the configurable logic device  24  by addressing the file in the memory  46  through latch  150 . The selected configuration file is output from the memory  46  over the data lines as 8-bit data words and loaded into the configurable logic device  24  at the data input lines shown in FIG.  4 . The configuration files for the Xilinx XC2018 logic cell array generated using the XACT development system available from Xilinx and stored in memory  24 , are contained in the Appendix. 
     Still referring to FIG. 4, in addition to providing the RF pulses, the configurable logic device  24  performs other functions. It provides the bias control signals on lines  86 A and  86 B to pins  5  and  7  on connector  110  to the two power amplifiers  36 A and  36 B (FIG.  1 ) 10 μs before the configurable logic device  24  passes an RF pulse burst. The configurable logic device  24  also controls the timing of the A/D  112  so that the A/D  112  converts the analog forward and reverse potentials received from the power monitor  26  over pins  1  and  3  of connector  110  into digital signals during the brief duration of each RF pulse burst. The A/D converter  112  is a high speed converter capable of making about 30,000 conversions per second, thereby providing digital conversions in real time. 
     The timing of inputs to the A/D  112  (FIG. 4) is controlled by the configurable logic device  24  through MUX  114  as follows. MUX  114  contains two 4:1 multiplexers, indicated in FIG. 4 by inputs X 0 -X 3  and output X, and inputs Y 0 -Y 3  and output Y. The detected forward and reverse power signals received from the power monitor  26  (via connector  110 ) are input to the second multiplexer at inputs Y 2  and Y 3 . Inputs Y 0  and Y 1  receive signals from the touch screen  58  (FIG.  1 ). The configurable logic device  24  uses the two inputs A and B of the MUX  114  to toggle the MUX  114  between the four inputs Y 0 -Y 3  and output it to the A/D  112  through the output Y. The other 4:1 multiplexer in the MUX  114  is used to provide signals to the touch screen  58  via pins  1  and  2  of connector  154 . The outputs from the A/D  112  are fed to the controller  48  which then feeds them to the processor  20  to be processed. 
     In this manner, the configurable logic device  24  controls the timing so that the detected analog forward and reverse RF power signals within each 65 μs RF pulse burst and the analog signals received from the touch screen are converted by the A/D  112  and supplied to the processor  20  by the controller  48  in real time so that the user can effect changes in system operation in real time. 
     In FIG. 4, U 22  is a bus transceiver coupled to the bus of the processor  20 , and J 1 -J 4 , JP 1  and JP 2  are connectors for interfacing the printed circuit board on which the components shown in FIG. 4 are mounted with the processor  20  and other components of apparatus  10  not mounted on the printed circuit board. 
     In accordance with further aspects of the present invention, user interface, data entry, total treatment time, and record keeping functions are controlled by a software program running on the processor  20 . In the preferred embodiment, the software is written in the Visual Basic programming language, a compiler for which is available from Microsoft Corporation. The source code for the software program is contained in the Appendix. 
     FIGS. 6-8 show screen displays through which the user enters patient information and selects treatment parameters. All pertinent patient data is entered through the screen display shown in FIG. 6, which contains a “QWERTY” type keyboard image 170 and icons  172  representing the categories of information to be entered, including patient name, patient ID number, patient age, name of facility in which treatment is being administered, patient&#39;s room/bed number, and patient&#39;s sex. Previously entered data for a patient already treated with the device may be recalled from a patient file stored in memory, such as hard disk, by touching the “Patient Files” icon on the screen display shown in FIG.  6  and entering some identifying information about the patient. Apparatus  10  then uses conventional search techniques to search for any existing patient files based on the identifying information entered by the user. 
     If no existing patient file is found or searched for, the user enters all the patient data. After all patient data has been entered, the apparatus  10  prompts the user for the next screen, shown in FIG.  7 . This screen display allows the user to enter desired treatment parameters, including peak power level (from 1 to 6, as shown in Table 1). pulse frequency (i.e., burst repetition rate, from 80 to 600 bps), and total treatment time, entered either by selecting one of the available choices (20, 30, 45, or 60), or entering any custom length of time (Custom Time™) by moving button  174  to a desired position along a bar  176  until the desired time appears in minutes in a treatment time field  178 . Once the treatment parameters have been selected, the user presses the “Start Treatment” icon to initiate the RF pulses. The processor  20  counts the time duration of the treatment until the total treatment time selected by the user is reached, at which point the processor  20  stops the treatment. 
     If the user retrieves the patient file for a previously treated patient, the treatment parameters for that patient are automatically entered into the fields in FIG.  7 . The user may then elect to use the same treatment parameters or change the parameters. This provides for the ability to improve the quality of treatments based on the effects of prior treatments and to save input time. 
     The screen display in FIG. 8 is a treatment screen which advises the user as to the selected power and frequency for the current treatment being administered and keeps track of the time remaining on a down counting timer  180 . The user can stop the treatment at any time by touching the “Pause” icon, and can restart the treatment by selecting the same icon, which changes to read “Resume” after a pause is initiated. While a treatment is paused, the apparatus  10  stops counting the total actual treatment time, and continues counting when the treatment is resumed. 
     At the end of the treatment, the apparatus  10  automatically stores the date and time, patient information, and treatment parameters, including the actual treatment time, into a patient file stored on the hard disk. If no patient file exists, the system creates a file and stores it. If a patient file already exists, the additional information is added to the file. FIG. 8 shows an example of a patient file, showing the information recorded and the file structure. The first line  182  of the file contains the date and time of file creation and identifying information about the patient, including (in order) patient name, patient ID number, facility, patient age, gender and room/bed number. The remaining lines  184  of the patient file each contain the date and time of a given treatment as well as the treatment parameters, including burst repetition rate, power level setting, and actual total treatment time. When an existing patient file is found and opened, the identifying information and last set of treatment parameters are retrieved from the file and displayed on the screen, enabling the user to use the same parameters for a new treatment or to change the information and/or parameters. 
     Apparatus  10  includes a help system for providing on-screen help to users. A help button  184  is provided on each screen, which when touched provides help information for that screen. 
     If desired, other information regarding a patient or research project may be input to the patient or research file. This may be done by inputting the information via down loading, as described below, or via an input device. For example, in the treatment of wounds, it would be desirable to have optical representations of the wound at various stages of the treatment. As shown in FIG. 1, optical data may be input into system  10  via any conventional digital imaging device, for example a conventional TV camera (e.g., a ccd device) or digital still camera  190 . The camera  190  may be controlled entirely by apparatus  10  to provide digital images of the wound to the apparatus  10  at any predetermined time immediately before, during or immediately after a treatment, or semi-automatically in response to prompts output by apparatus  10  on display  56  and commands input on the touch screen  58 , or manually in response to user control of apparatus  10 . Programs for controlling the digitizing and input of optical images to apparatus  10  may be conventional and are known or can easily be constructed by those of skill in the art. Apparatus  10  may also be provided with sound input and playback to provide multi-media operation similar to that in current personal computer systems. A microphone, speakers, CD ROM drive, etc., may be provided in known manner to implement multi-media operation. 
     Referring to FIG. 1, patient file information and/or parameter settings may be down loaded from and/or up loaded to and/or modified by other apparatus, for example, through a serial port  192  (e.g., according to the RSC-232-C standard) coupled to processor  20 . Such down loading, up loading, and modification may be accomplished remotely via a modem  194  and a telephone line, or an ISDN telephone line, or any other suitable communication link and associated hardware and software. Up loading, downloading and remote access are conventional and well known, and further details therefore are not supplied herein. 
     The apparatus  10  may be provided in modified form to carry out a programmed treatment with no or little user input other than initiating the treatment. A programmed treatment may be loaded via the serial port  192 , including programming to cause the display to provide minimal prompts and the touch screen to accept minimal inputs, limited to, for example, power on/off, start and stop. The modified apparatus may include all or part of the patient file system described above for apparatus  10 , including up and down loading. The modified apparatus may be provided with a digital imager  190  and multi-media capability to enhance and simplify data collection during transportable use of the modified apparatus. Also, the modified apparatus need not include a display and touch screen, but simply may be provided with an on/off switch and a start/stop switch or switches. 
     While the invention has been described and illustrated in connection with preferred embodiments, many variations and modifications as will be evident to those skilled in this art may be made without departing from the spirit and scope of the invention, and the invention as set forth in the appended claims is thus not to be limited to the precise details of methodology or construction set forth above as such variations and modification are intended to be included within the scope of the appended claims.