Abstract:
A therapeutic electrostimulation apparatus and method operates to supply electrostimulation signals to three channels. The basic electrostimulation signal for each of the channels is the same; and this signal is applied to a transcranial electrostimulation set of output electrodes. A second channel provided with the same signal is further operated to modulate the signal with a dual frequency signal pattern for the application of the second channel signal to a second set of electrodes, typically applied to the body near the spinal area. A third channel supplied with the basic electrostimulation signal modulates the electrostimulation signal during a portion of a treatment session with a diapason of frequencies varying randomly, and the output of this channel is applied to a set of electrodes at a local area for therapeutic treatment.

Description:
BACKGROUND 
       [0001]    Bio-electric stimulation apparatus has been developed for applying current pulses to a patient through electrodes located on opposite sides of the head of the patient. The current pulses at selected frequencies are applied to cause reaction with the central nervous system of the patient. Such devices, referred to as transcranial electrostimulation (TCES) or cranial electrostimulators (CES) have been used for a variety of non-invasive procedures, such as producing analgesic effects, reducing or controlling migraine headaches, and other applications of treatment and electro-anesthesia. 
         [0002]    Earliest prototypes of transcranial electrostimulation devices originated in Russia. These original designs, although successfully employed for several different treatment modalities, had a severe drawback with regard to the comfort of the wearer or patient. In some cases, these earlier cranial electrostimulation devices even subjected the wearer to pain. It has been discovered that the reason for the discomfort of these earlier designs was a result of the use of direct current as part of the overall operation of the devices. The direct current was used to break down or lower skin resistance to allow the treatment alternating current signals to penetrate the brain and nervous systems to cause the desired effect established by the placement of the electrodes on the head of the patient. 
         [0003]    In these earlier types of machines, the wearer received a combination of direct current and alternating current electrical waveform packages through a series of electrodes affixed to the head with straps. Typically, two electrodes comprising a cathode or negative pole of the DC based circuit would be placed approximately three inches apart to the left and right of the center of the forehead. Two other electrodes, comprising the anode or positive pole of the DC based circuit, were placed on the rear of the skull on the post mandibular area behind and below each ear. 
         [0004]    With this DC current based design, the wearer was required to place a thick pad between any electrode and the skin. Typically, the pad was comprised of several layers of unbleached and uncolored cotton flannel, or an equivalent product. For best results, the fabric pads were soaked with water to provide a conductive path between the electrodes and the skin of the wearer. Without the presence of the pads (which were only required because of the presence of the DC current), such devices could either burn the skin of the wearer, or cause relatively intense pain before a usable level of the treatment modality of the currents at the AC frequency could be reached. 
         [0005]    Although various types of treatment were employed by such earlier transcranial electrostimulation devices, the devices typically needed to be employed for an average time of thirty minutes per treatment period. Without the presence of the relatively thick cumbersome pads, the DC based design was unusable. With the presence of the thick padding, the DC design was bearable to the wearer, but rarely provided the wearer with a pleasant experience. 
         [0006]    Three Russian patents which utilize such devices for different treatment methods comprise Russian patent Nos. 1489719; 1507404; and 1522500. In all of these patents, a combination of direct current and rectangular impulse current, with a frequency of between 70 and 80 Hertz, was employed at current amperages which were increased from a relatively low level to a higher or maximum level over the course of each treatment session. 
         [0007]    An additional and potentially harmful drawback of the DC based designs was that of iontophoresis. A characteristic of a DC circuit application of this type is that molecular sized parts of metal, toxins and other undesirable impurities can be caused to migrate in the direction of current flow through the skin and into the bloodstream of the wearer of such DC based CES devices. Consequently, care had to be taken to ensure that no substance was present other than water used to create good electrical contact with the pad to the skin of the wearer. Since practically all CES treatment modalities require repeated treatments, the potential for iontophoresis being a harmful factor was escalated. 
         [0008]    Transcranial electrostimulation (CES or TCES) originally was used in the 1960&#39;s to induce sleep. These early devices typically used less than 1.5 mA at 100 Hz. The Liss U.S. Pat. No. 4,627,438 employed higher frequencies modulated by a lower frequency squarewave to produce recurring pulse bursts. The repetition frequency of the device of Liss is determined by the modulation frequency; but the pulse bursts are of a uniform amplitude within each repetition cycle. The device of the Liss patent is specifically directed to utilization in conjunction with the treatment of migraine headaches. The low frequency or modulating signal is asymmetrical, utilizing a 3:1 duty cycle, “on” three-fourths of the time and “off” one fourth of the recurring period. This results in bursts of the high frequency signal separated by the off time when no signal is applied, following the re-application of the bursts of the high frequency signal. Some patient discomfort may be present in such an “on/off” system operation over the period of time of application of the pulse during a treatment interval. 
         [0009]    A number of other United States patents, all directed to dual frequency systems which utilize high frequency signals modulated by a low frequency modulation carrier, operating in the general nature of the device of the Liss U.S. Pat. No. 4,627,438, exist. Typical of these patents are the patents to Limoge U.S. Pat. No. 3,835,833; Nawracaj U.S. Pat. No. 4,071,033; Kastrubin U.S. Pat. No. 4,140,133; Morawetz U.S. Pat. No. 4,922,908 and Giordani U.S. Pat. No. 5,131,389. All of these patents employ a uniform amplitude high frequency signal, which is modulated at the lower frequency of the modulation carrier. 
         [0010]    A variation on the systems of the patents discussed above is disclosed in the Haimovich U.S. Pat. No. 5,540,736. The device of this patent employs two different current generators for providing electrical currents delivered to two electrode pairs operating across different portions of the head of the patient. This allows independent control of the current generators to administer independent regulated electrical current across each of the pairs to adjust for different impedances caused by the physiological and anatomical differences between different sides of a patient&#39;s mid brain portion, the quality of the conducting medium, and other factors. In all other respects, the system disclosed in this patent is similar to the operation of the system disclosed in the Liss patent discussed above. 
         [0011]    Russian patent publication No. 2139111 is directed to a method for treating narcomania, which is a treatment also used in others of the CES patents described above for alcohol and narcotic addiction. In this patent, transcranial electrical stimulation is accomplished by means of packets of current with a duration of four milliseconds, at a modulation frequency of 100 Hz. Within each of the packets, the high frequency signals have a uniform frequency and current amplitude. 
         [0012]    The Katsnelson U.S. Pat. No. 6,904,322 is directed to a transcranial electrostimulation apparatus which employs an asymmetrical signal modulated by a 77.5 Hz modulating signal, with a resultant lowering of the capacitive resistance of the epidermal layer. As a consequence, lower current levels using the Katsnelson system of the &#39;322 patent were found capable of achieving the desired results which previously required much higher current levels. The lower current levels of this system translate into a greater level of comfort for the patient or user of the device of the Katsnelson patent. 
         [0013]    There also have been a number of efforts in the past to apply electrical signals to multiple body sites, in an effort to obtain some type of therapeutic result, such as pain relief. Early efforts, such as disclosed in the Phurston U.S. Pat. No. 309,897 and Gavigan U.S. Pat. No. 693,257, apply direct current to pads located at different locations on the body. These devices are subject to the same disadvantages described above for direct current TCES and CES systems, inasmuch as a relatively high level of discomfort or pain may be experienced through the use of direct current applications. Other devices employing stimulation of electrodes applied to the skin or external areas of the body, or implanted in permanent locations for therapeutic purposes, have been devised using alternating current signals. Such devices, however, have not been coordinated or combined with the use of transcranial electrostimulation apparatus, or cranial electrostimulators. 
         [0014]    It is desirable to provide a system which combines transcranial electrostimulation with therapeutic stimulation to other body locations utilizing coordinated signals between the transcranial electrostimulation apparatus and the other applications to improve the efficacy of the treatment, and to obtain increased user comfort. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWING 
         [0015]      FIG. 1  is a diagrammatic drawing illustrating the overall principles of operation of the system in accordance with an embodiment of the invention; 
           [0016]      FIG. 2  is a waveform of a typical signal pattern of an embodiment of the invention; and 
           [0017]      FIG. 3  is a block diagram illustrating additional details of the system of the embodiment of the invention shown in  FIGS. 1 and 2 . 
       
    
    
     DETAILED DESCRIPTION 
       [0018]    Reference now should be made to the drawings which illustrate an embodiment of the invention and its operation.  FIG. 1  is a diagrammatic representation of the salient operating features of circuitry implementations which produce a unique triple waveform asymmetry useful for various transcranial electrostimulation applications combined with simultaneous electrostimulation applications to other portions of human anatomy for maximum therapeutic efficacy. The waveform which is described in detail in conjunction with  FIG. 2  produces little to no discomfort to the user of the device when applied to the head area for transcranial electrostimulation, and similarly, produces little or no discomfort when applied to other areas of the anatomy, as subsequently described. 
         [0019]    As illustrated in  FIG. 1 , the basic high frequency current signals are produced by a high frequency generator  10 , which may employ a frequency control  12  and a pulse duration control  14  to establish the basic frequency and to provide the desired asymmetry between the positive and negative portions of each of the pulses produced by the generator  10 . Typically, the generator  10  may include a crystal oscillator operating at 1,000 to 1,200 kHz, which then is divided down to the desired operating frequency of the alternating current pulses applied to the transcranial stimulation electrodes and to additional electrodes applied to the spinal cord area, and to a peripheral pain area, such as a knee, elbow or the like. Typically, the division ratio may be a 1:4 ratio to produce signals which then are modulated by a low frequency generator  16 . 
         [0020]    As illustrated in the diagrammatic representation of  FIG. 1 , the output of the low frequency generator  16  may be established by means of a conventional frequency control  18 , a pulse duration control  20 , and a modulation depth control  22  to produce a composite modulated output signal at  24 . The signal  24 , which comprises the pulses from the output of the high frequency generator  10  modulated by the low frequency generator  16  then is provided to three different channel outputs  24 A,  24 B and  24 C. 
         [0021]    Each of the channel outputs is further provided with a corresponding amplitude control  26 A,  26 B and  26 C, respectively, to establish the amplitude of the pulse train supplied to the system through three corresponding power amplifiers  28 A,  28 B and  28 C, respectively. The current at each of these power amplifiers  28 A,  28 B and  28 C may be varied in accordance with the treatment modality to be used by the system; and this current is measured by the respective ammeters  34 A,  34 B and  34 C. The various power amplifiers  28 A,  28 B and  28 C then supply the appropriate alternating current pulses to multiple pairs of electrode outputs, illustrated as pairs  30 A/ 32 A;  30 B/ 32 B; and  30 C/ 32 C in  FIG. 1 . As indicated in  FIG. 1 , the electrode outputs  30 A/ 32 B are applied to the head area, or for transcranial electrostimulation; the electrodes  30 B/ 32 B are applied to the spinal cord area of a human anatomy; and the electrodes  30 C and  32 C are applied to a peripheral area of a human anatomy, as mentioned above. 
         [0022]    It also should be noted in the circuit of  FIG. 1  that in addition to the amplitude control, the channel  2  output  24 B also is further modulated by a modulation frequency control  25  of dual frequencies. Similarly, the channel  3  output  24 C is additionally controlled by a modulation frequency control  27 , which applies a diapason of modulation frequencies to the channel  3  output. The result is that while the three-channel outputs from the channel outputs  24 A,  24 B and  24 C all are supplied with an identical signal from the low frequency generator  16 , the outputs are not identical when they are finally applied to the respective power amplifiers  28 A,  28 B and  28 C to the corresponding output electrodes. The variations are made by the modulation frequency control circuits  25  and  27 , which are coupled with the channel  2  output  24 B and channel  3  output  24 C, respectively. 
         [0023]    The operation of the disclosed embodiment of the invention produces a waveform having triple asymmetry in order to produce effective transcranial stimulation and further effective stimulation to the spinal cord area and to a peripheral body area, such as an elbow, knee, finger, or the like. The waveform of  FIG. 2  and the block diagram of the system shown in  FIG. 3  further illustrate the nature of the signals, and the manner in which these signals are processed. The block diagram of the system shown in  FIG. 3  is typical of the manner of implementation of the various circuit functions required to produce the waveform of  FIG. 2 ; but other arrangements for producing the signal waveform also may be utilized. 
         [0024]    In  FIG. 3 , a crystal oscillator  50  is employed to provide the basic alternating current operating signals utilized for both the high frequency pulses and the modulating pulses, illustrated in  FIG. 1  as being produced by the high frequency generator  10  and the low frequency generator  16 , respectively. Typically, the oscillator  50  may have an operating frequency in the order of 1,000 kHz to 1,200 kHz (although other frequencies may be used). In  FIG. 3 , the output of this oscillator is supplied in parallel to three dividers  52 A,  52 B and  52 C, which each may comprise multiple division stages, to produce the lower modulating frequency (illustrated in  FIG. 1  as being generated by the low frequency generator  16 ). The output signals from the oscillator  50  also are supplied in parallel through three frequency dividers  54 A,  54 B and  54 C to produce the operating signal waveform shown as the squarewave signal in the waveform of  FIG. 2 , after being shaped by a pulse shaper  56 A,  56 B and  56 C, respectively, to achieve the generally squarewave configuration of the signal shown in  FIG. 2 . In the example given, these pulses occur at an alternating current rate of 100 KHz; although they could be at higher or lower frequencies in accordance with particular applications of the system. 
         [0025]    The pulses from the output of the dividers  54 A,  54 B and  54 C are respectively supplied to counters  60 A,  60 B and  60 C, which may be of any suitable type such as a cascade counter or a ring counter, for producing outputs on sets of leads  64 A/ 66 A;  64 B/ 66 B; and  64 C/ 66 C, respectively, utilized in controlling the amplitude of the pulses from the corresponding pulse shapers  56 A,  56 B and  56 C. The counters  60 A,  60 B and  60 C are reset by the outputs of their respective dividers  52 A,  52 B and  52 C, applied over the respective leads  62 A,  62 B and  62 C, to reset the counters  60 A,  60 B and  60 C for each cycle of operation of the corresponding dividers  52 A,  52 B and  52 C. In the present example, the output of the dividers  52 A,  52 B and  52 C (comprising the low frequency modulation control signal described previously in conjunction with  FIG. 1 ) is selected to be 77.5 Hz, since this repetition frequency has been found to be highly effective in conjunction with transcranial electrostimulation devices. Repetitive frequencies which are in the range of 70 Hz to 85 Hz have been found to be effective, but a frequency of 77.5 Hz has been empirically ascertained as a general ideal operating frequency for producing the maximum efficacy of the system, particularly for the transcranial electrostimulation, which takes place from the channel  1  output electrodes  30 A/ 32 /A applied to the head area of a person. 
         [0026]    The modulating or reset frequency, applied over the leads  62 A,  62 B and  62 C, could as well be supplied by a second independent crystal oscillator, operating at a lower initial frequency than the frequency of the oscillator  50 , if desired. If two different signal sources are employed, synchronization between the two should be effected to cause the various pulse transitions of the signals to be correlated with one another in order to produce the signal waveform of  FIG. 2 . The system shown in  FIG. 3 , however, is an effective way of accomplishing this purpose. 
         [0027]    Assume, for the present example, that the counter  60 A has been reset to its initial or “zero” count. The system then operates to supply output pulses at the high frequency of the divided down signal from the divider  54 A to the counter input, which advances one count for each of the applied pulses. In the waveform shown in  FIG. 2 , the initial pulses (the first four in  FIG. 2 ) cause the counter outputs on  64 A and  66 A to be such that, as these outputs are applied to the amplitude control  68 A, a maximum amplitude (which may be adjusted if desired) is produced. This is illustrated in the left-hand portion of the waveform signal of  FIG. 2 . 
         [0028]    When pulse No. 4 in the group or packet of pulses is applied, a signal is obtained from one or both of the outputs  64 A and  66 A of the counter  60 A and applied to the amplitude control circuit  68 A to switch it to a lower amplitude, as illustrated for the right-hand portion of the signal shown in  FIG. 2 . This causes the output of the amplitude control circuit  68 A, as applied to a regulator amplifier  58 A, to produce the signal waveforms in the asymmetrical pattern shown in  FIG. 2 , wherein the left-hand one-fourth ( 42 ) of each of the signal burst envelopes  40  is at a high amplitude; and the right-hand portion ( 44 ) comprising the remainder of the pulses in the burst envelope  40  is at a lower amplitude. The ratio is such that one-fourth (the initial amplitude) is at the high amplitude range  42 , and that the remainder three-fourths of the signal burst is at the low amplitude range  44 . This is the first level of asymmetry of the applied signals. 
         [0029]    The regulator amplifier  58 A also operates on the squarewave shaped pulses from the pulse shaper  56 A to cause a second asymmetry in the positive and negative going aspects of the signal. As shown in  FIG. 2 , the negative going amplitude is one-fourth of the total excursion of the signal; and the positive going portion is three-fourths of the total excursion. This is true of both the maximum amplitude pulse burst  42  at the beginning of each of the burst groups or packets, and the lower amplitude portion  44  at the end of each of the burst groups or envelopes. 
         [0030]    Finally, a third asymmetry is produced within the thirteen millisecond squarewave burst envelope illustrated as  40  in  FIG. 2 . This is the result of the operation of the divider signal on the lead  62 A comprising the reset operation for the counter  60 A. The pulse time, or dwell time, for the positive-going aspect of the signal is one-fourth of the total pulse width; while the pulse time for the negative-going aspect of the signal is three-fourths of the total pulse width. 
         [0031]    The composite asymmetrical signal illustrated in  FIG. 2  then is provided by the output of the regulator amplifier  58 A to a power amplifier  70 A. The amplification may be adjusted to change the amount of current applied by the system (while maintaining the relative waveform shapes and patterns shown in  FIG. 2 ) in accordance with the treatment modality to be utilized by users of the system. The ammeter  74 A is employed to measure the magnitude of the current supplied by the system. The ammeter  74 A may be a simple analog ammeter, or it may be a digital ammeter providing separate readings of the maximum amplitude and minimum amplitude portions of the signal which is shown in  FIG. 2 . 
         [0032]    The output of the amplifier  70 A may be applied through a polarity switch  72 A which allows the polarity of the signals applied to the output electrodes to be reversed, if desired. The polarity switch  72 A supplies the signals across a pair of spaced output electrodes  76 A and  78 A which may be in the form of pairs of split anodes and split cathodes, or which may be a single “anode” and “cathode” pair, or any combination thereof. These are the electrodes which are applied to the head area of the user for transcranial electrostimulation. Since no direct current components are present, the electrode paths connected to the outputs  76 A and  78 A are not really anodes and cathodes; but, depending upon the treatment which is being effected, it may be desirable to apply the positive going portions of the pulses to one or the other of these electrodes and the negative going portions to the other of the two electrodes  76 A and  78 A to achieve specific results. 
         [0033]    It should be noted that in the system which is shown and described, there are no direct current components. It also should be noted that although the system essentially is illustrating 70 kHz to 120 kHz tone bursts in each of the burst envelopes  40  shown in  FIG. 2 , other frequencies could be employed. The 77.5 Hz waveform derived through the timing cycle is used to complete each burst envelope  40  including first pulses of a relatively high amplitude, followed by a series of pulses of relatively low amplitude in accordance with the signal pattern shown in  FIG. 2 . The frequency of pulses comprising the asymmetrical tone burst is approximately 1,150 to 1,450 times the repetition frequency of the burst envelopes  40 . 
         [0034]    In the system which is described above, an individual squarewave pulse of 0.01 Ms is utilized with 0.0075 Ms in the negative portion of the pulse and 0.0025 Ms in the positive portion of each of the pulses. The general asymmetrical waveform which is described above in conjunction with  FIG. 2  has been found to be effective when it is centered around three-to-one ratios throughout the system operation. These ratios of course may be varied, in accordance with corresponding variations of other ratios of the system; but it has been found that the asymmetrical relationship which is disclosed replaces the formerly necessary, but unpleasant, DC portion of the operating protocol of earlier systems. 
         [0035]    It has been found that the utilization of the unique asymmetrical signal produced by the system shown in  FIG. 3  and illustrated in the waveform of  FIG. 2  effectively lowers the capacitive resistance of the epidermal layer to something on the order of 100 Ohms. Since less resistance is presented to the integrated 77.5 Hz modulating frequency, lower current levels are capable of achieving the same desired result which previously required much higher current levels. The lower current levels translate into-a greater level of comfort for the patient or user of the device. 
         [0036]    The signals supplied to the channel  2  and channel  3  outputs, illustrated as  24 B and  24 C of  FIG. 1 , are processed through essentially identical circuitry in  FIG. 3 , with the exception that in conjunction with the channel  2  output  52 B through  78 B and the channel  3  output  52 C through  78 C, the additional modulation which is indicated as applied by the modulators  25  and  27  ( FIG. 1 ), respectively, for the number 2 and number 3 channel outputs is employed. In all other respects, the operation of these additional channels employs the same basic signal shown in  FIG. 2  and described above in conjunction with  FIG. 1 . 
         [0037]    In conjunction with channel  2 , the power amplifier  70 B is provided with an additional or second modulation frequency control by the modulator  25  shown in  FIG. 1 , coupled to the power amplifier  70 B in any suitable manner. The additional modulation frequency switches between two frequencies in the range of 0.01 Hz and 100 Hz. Two empirically chosen frequencies of 7.75 Hz and 77.5 Hz for modulating the signal pattern of the signal bursts of  FIG. 2 , have been found to produce satisfactory results. These modulation frequencies each are applied for a relatively long period of time, on the order of thirty to forty minutes during a treatment session. The system starts with the modulation frequency of 77.5 Hz applied by the modulator  25 , which then is followed, after an appropriate interval, typically one-half of the session duration, with the lower modulating frequency of 7.75 Hz for a similar length of time. The switching between the two modulating frequencies continues from the higher frequency to the lower frequency, and back again, over a therapy session, which typically lasts on the order of thirty to forty minutes. The output electrodes  76 B and  78 B (or  30 B and  32 B of  FIG. 1 ) of channel  2  are applied to different locations on the back vertebrae, typically at the lower back. The amplitude of the channel  2  current ranges up to 150 mA. 
         [0038]    The Channel  3  portion of the system, indicated from the divider  52 C through the output electrode  78 C, also is supplied with the signal of  FIG. 2  in the same manner as that signal is applied to the channel  1  and channel  2  portions of the system. The channel  3  output electrodes  76 C and  78 C (or  30 C and  32 C of  FIG. 1 ) are used for peripheral stimulation. For example, if the therapeutic treatment is for pain in a knee or an elbow, the electrodes are placed across the appropriate areas for treatment. The signal frequency applied to the dividers  52 C and  54 C is obtained, as described above in detail for channel  1 . The 77.5 Hz signal burst envelopes  40  are then further modulated with a third modulation frequency within a diapason of frequencies (typically between 0.01 Hz and 10 Hz). A range from 7.75 Hz to 0.775 Hz has been found effective. The basic modulation is 77.5 Hz, as with the modulating frequency for channel  1 , and as with one of the modulating frequencies for channel  2  ( 52 B through  78 B). The depth of the modulations is the same as used for channel  1  ( 52 A through  78 A). 
         [0039]    The starting frequency for channel  3  is selected to be 77.5 Hz, for the first portion of a treatment session, with the diapason frequencies of 7.75 Hz to 0.775 Hz then continuing for the second portion of a treatment session. As with channel  2 , the channel  3  current amplitude ranges up to 150 mA. A typical treatment session lasts between thirty minutes and forty minutes. For such a treatment session, the frequency of modulation for the burst envelope for channel  1  is 77.5 Hz continuously, throughout the session. For channel  2 , the modulation frequency for the first half of the session (15 or 20 minutes, depending upon the session length) is at 77.5 Hz. During the second half of each treatment session, the modulating frequency for channel  2  drops to 7.75 Hz. For channel  3 , the modulation frequency during the first half of the treatment session is the basic 77.5 Hz frequency; but during the second half of the treatment session, the modulating frequency for channel  3  switches to a frequency in the diapason of 7.75 Hz to 0.775 Hz for the remainder of the second half of the session. The frequency changes in this diapason are random change every two or three minutes. This typically completes a treatment session. For some situations, however, the entire session may be repeated, with everything going “back again” to the starting conditions mentioned above, and then repeating the operation described. 
         [0040]    The application of the signal of  FIG. 2  to the three channels (with the additional modulation described for channels  2  and  3 ) used together with the 3 output electrode sets results in improved therapeutic relief over that which is obtained from TCES (channel  1 ) used alone. A synergism of the three signals appears to produce more lasting beneficial results. 
         [0041]    The foregoing description of an embodiment of the invention is to be considered as illustrative and not as limiting. Various changes and modifications will occur to those skilled in the art for performing substantially the same function, in substantially the same way, to achieve substantially the same result without departing from the true scope of the invention as defined in the appended claims.