FI59203B - ELECTROMEDICAL APPARATUS FOR THERAPEUTIC BEHANDLING AV CELLER OCH / ELLER LEVANDE - Google Patents

Description

ΓβΊ «. ^ ANNOUNCEMENT R ΠΛΛ 7 $ ΒΓφ 1¾ O *) UTLÄCGNI NGSSKRIFT ^ ^ ^ c <4s> 2¾10 ^ ^ (S1) K» .ik3; i «.ci.3 A 61 Η 1/32 FINLAND —FINLAND ( 21) P »t« 0tttl »k * imi · —P *« ntw »ehn4nf 189/73 (22) Hakemlipllv · —Anrtknlnpd · * 2k. 01.73 (13) AtkupUvft — GIMgh «tad * g 2U.01.73 (41) Tullut JulklMksI - Bllvlt offancllg 29.07.73

National Board of Patents and Registration (44} Date of Nihttvtiuipano

Patent and Registration Office AmMon utigd och «ijkrtfwn pubikwrad 31.03.81 (31) (33) (31) • tuolkeut — B« | «rd priority 28.01.72 19.09.72, 22.12.72 USA (US) 221653, 290391 315901 (71) ESB Incorporated, 5 Penn Center Plaza, Philadelphia, Pennsylvania 19103, USA (72) Michael Richard Manning, Philadelphia, Pennsylvania, USA (US) (7U) Leitzinger Ltd (5U) Electromedical device for cells and / or living for therapeutic treatment of tissue - Electromedical apparatus for therapeutic treatment of cells and / or blood cells

The invention relates to an electromedical device for the therapeutic treatment of cells and / or living tissue in a body living in a predetermined area, which device comprises a device for generating a wave-shaped electrical signal. Such a device is useful in the therapeutic treatment of cells or living tissue, especially when the cells or tissues require a "bioelectric" signal, an expression defined later, to artificially stimulate the healing, growth or regeneration of the cells or tissue.

As used herein, the term "therapeutic treatment" does not only mean the enhancement, growth or regeneration of desired cells or tissues by augmentation or. but also to increase the breakdown or destruction of unwanted cells or tissues.

In this context, the term "bioelectric signal" means a signal that activates either a mechanism that promotes the healing of cells or tissues in a living entity, or that promotes the non-functioning cells of a living entity, or. tissue breakdown or destruction.

As used herein, the term "reactive coupling" encompasses 2,520,203 of either capacitive coupling or inductive coupling, or both.

The invention is described in detail in particular for bone growth or bone repair or. in connection with the promotion of healing, since the device according to the invention has been specially developed for such use. However, the device according to the invention can be used therapeutically for all biological processes which react to bioelectrical signals or which can be affected by bioelectrical signals.

It is known among biologists that electrical activity is involved in most, perhaps all, cellular events. In this case, it is particularly interesting that accidents, such as fractures or. cracks, limb amputation, and so on are usually associated with so-called "accidental injury", which can be recorded as current intensity or voltage. What is important here is that the electrical activity observed after the accident is always different from that observed before the accident, i. after the accident, the electrical behavior is abnormal. Although the relationship of this phenomenon to actual cellular events, such as tissue healing or growth, is not. It is not clear yet, it has been found that the electronic whole.active.in artificial control or. Changing the area of the accident can sometimes promote healing.

In the specific case of bone healing, it is known that both this event and normal bone remodeling are associated with electrical phenomena. Tension in the bone and surrounding tissue is caused by or. piezoelectric properties, which are natural phenomena and the most likely reason that in most cases bones heal naturally, seem to cause these electrical phenomena. In order to study this electrical effect, and in an attempt to further promote bone healing, electrodes have been implanted directly into areas of fractures. In most cases, the controlled electrical parameter was continuous, i. pulsating direct current. In the few cases where electrical input signals other than DC were used, the overall effect was that there was a bipolar voltage at the tissue level, with the amplitude and frequency components of the second polarity corresponding to the corresponding components of the opposite polarity, i. the operating voltage was sinusoidal (alternating current). Also at the pulsating DC current, the voltage was bipolar at the tissue level, with the amplitude and frequency components of both polarities being equal.

In the second special case of regeneration, it has long been assumed that the factors regulating regeneration are electrical events in the amputation region associated with the central nervous system. In order to artificially stimulate regeneration in mammals (rats), implants using implanted and continuous DC signals were used. A partial regeneration of the limb was achieved, which would not otherwise have occurred in nature.

In all the specific cases mentioned above, as well as in most biological events involving cellular activity, it is obvious that electronic events play an important role. Most hitherto known cure. However, the emphasis has been on continuous DC signaling. I use stimulation as a source. This has several major disadvantages, such as: A. because it is limited to the use of direct current and current, not all the information (coding) that can. be incorporated into electrical energy or signals when they are finally coupled at the cellular level, B. the efficiency of energy transfer is unnecessarily and severely limited, C. selective excitation cannot be achieved at the cellular level as a result of the above disadvantages A and B, D. by far the use of implanted electrodes certain restrictions on electrode / electrolyte interfaces. For example, no electrode material. is not completely inert to direct current at any voltage when in contact with body fluids.

E. The use of implanted electrodes can be toxic. due to the possible weak Faraday reaction that occurs and the electrodes themselves are poisoned in long-term implants, F. the use of implanted electrodes, in which the excitatory source is also implanted, requires surgical pre- and post-treatment, G. when the stimulating source is placed outside the living object led by .hi, the route of infection passes through the skin from the environment to the body cavities and internal organs, there is a risk of superficial or internal infections.

From the above, it can be seen that bone growth can be promoted by altering electrical potentials in the region of fracture or rupture. It has been found that a naturally occurring electrical voltage or a naturally occurring voltage difference starting from a point close to a member and extending to the farthest end of the member rises more or less linearly. However, when there is a fracture or. interruption, normally occurring voltages change strongly. The change in stress distribution is assumed to be part of the natural mechanism by which it indicates that the skeleton needs to be repaired, in which case it is associated with bone growth. Although experimental and clinical data do not sufficiently support the claim, it can be assumed that the distribution of potentials also indicates the need for repair due to other quality injuries, such as contracted muscle tissue, ruptured muscle tissue, and scratches, bruises, and wounds.

The present invention uses the principle that a bioelectrical signal at the cellular or tissue level in a living organism artificially stimulates the healing of cells or tissue in the living organism. Although this mechanism is not yet known, it is assumed that the cell membranes that form the interface or contact surfaces between the external or internal fluids of the cell function in the same way as the electrode / electrolyte contact surfaces. The biological processes that take place can be stimulated or. in non-stimulatory cell membranes, can be expected to be voltage or potential dependent, such as voltage or potential dependent processes that occur at the electrode / electrolyte contact surface. Accordingly, it is assumed that the cell membrane is n. stored in significant amounts due to bilayer, adsorption, absorption, and desorption phenomena. Redox processes can also take place at these contact surfaces. In other words, it is hypothesized that cellular events may be affected by phenomena occurring in cell membranes, and that the membrane acts as an electrode. As a result, it can be affected by local voltage changes, which can, for example, cause the absorption or desorption of a critical, chemical intermediate (dissociated or non-dissociated) (to achieve a specific healing process associated with it).

Based on the principles described above, it is an object of the invention to provide an electrical signal with a suitable frequency content which can be used for the selective and effective artificial therapeutic treatment of cells and tissues without the disadvantages set out in A to G above.

59203

Previous experimental and clinical work, as well as other experimental and clinical findings, have been utilized to provide an artificial, regenerative electrical voltage in a predetermined zone of living tissue in which a need for repair is indicated to achieve the object of the invention.

To achieve the object of the invention, the device according to the invention is characterized in that the signal generating device is arranged or adjustable to generate an operating signal in a waveform in which the wave decay time differs at least tenfold from its rise time and further comprises means for reactively switching the operating signal to a predetermined range. The new and unexpected technical effect provided by the invention is based on the fact that complex and cumbersome electrodes and the like which have to be installed and surgically removed can be completely avoided, since the special operating signal according to the invention is reactively coupled to the operating area. The possibility of reactive signal transmission is known per se, as it is well known that living tissue has both capacitive and inductive properties. However, for the purpose of the invention, reactive coupling of a signal has not been previously proposed, nor has it been previously found that reactive transmission of a signal in the form of the invention works particularly well in practice. This is based on the fact that the electric current caused by the signal is considerably larger in the other direction than in the opposite direction. The resulting voltage drop causes a different voltage distribution in and over a predetermined zone of tissue, and the effect accumulates along with the naturally occurring potential change to promote and accelerate the repair mechanism, allowing damaged tissue to recover more quickly.

Based on the fact that the naturally pulsating increase in voltage that occurs when a living object tissue is damaged promotes healing, the opposite result can be expected when this voltage is attenuated or reduced, although experimental and clinical demonstrations are not yet complete. In this context, it is known that there are changes in tension in both benign and malignant tumors that appear to inhibit the ability of the body to destroy abnormal cells. The development of such tumors can be inhibited if the normally occurring voltage difference is altered by initiating a process designed to remove diseased or, in fact, foreign cells in the body. Experimental evidence supports this theory only 59203 to a limited extent. With the present invention, it may be possible to trigger an intuition-rejection reaction or some mechanism of destroying tumors in the body.

The invention will be described in more detail below with reference to a couple of embodiments and drawings, in which Figures 1 and 2 are schematic circuit diagrams of embodiments of an electropharmaceutical according to the invention, Figures 3 and 4 show schematically. electrical signals useful in explaining the effect of the schematic circuit diagrams of Figures 1 and 2, Figures 6 and 7 show an electromedical device according to the invention and the patient for which it is used, with a portion of the patient being shown schematically, and Figure 7 schematically showing a mechanical device according to the invention.

Figure 1 shows an embodiment of a bioelectrical device according to the invention. The circuit of Figure 1 is a substantially two-phase frequency-adjustable complementary astable blocking oscillator or astable. a multivibrator, which generates a pulsating output voltage or an electrical signal having a rotating waveform shown in Fig. 3 over its output terminals 20 and 22. For example, each torsion wave can be adjusted in duration. An example is a waveform with a duty cycle of 0.01 seconds, a rise time of 0.0001 seconds, and a fall time of 0.0099 seconds.

A pair of electrodes 50 and 52 are electrically connected to output terminals 20 and 22 via wires 54 and 55. Electrical energy in the form of saw blades or swirling waves is capacitively applied by electrodes 50 and 52 to an "external load" 24 representing a predetermined tissue zone in living tissue or object in which injury or abnormality has occurred in vivo. In the case of bone healing, the load may be considered on the patient's arm, or on the foot, where cracks, fractures or breaks occur in the area of the bones, said area of bone being between the electrodes. In this context, it is best preferred that one of the electrodes be located farther from the tissue zone than the other and that it be larger in size to reduce the density. This will be explained in more detail below with reference to Figure 5.

In the method of the present invention, the device utilizes the fact that an electric current can be induced in a living tissue or object by means of a reactive signal transmission. The living object forms a conductive medium, the resistance of which depends on the tissues or body fluids. Since a capacitor is then formed between the electrodes and the body, as will be explained in more detail below, the embodiment of Fig. 1 is primarily an example of capacitive transfer. In the following, reference is made to the waveform of Figure 3. First, a voltage is applied between the electrodes 50 and 52, which rises in a very short time, as indicated by the dots RST in Fig. 3. This is followed by a voltage drop over a substantially longer period of time, denoted by the points TU. The cycle repeats when the voltage rises rapidly in the positive direction, after which the voltage slowly decreases in the negative direction. The voltage can travel either positively or negatively depending on the observer's definition. The rise time and the fall time can also occur in a positive or negative direction, and in the present invention the rise time is a part of the signal of Figure 3, which is specifically intended to provide the desired therapeutic signal at the cellular level, i. the part given by the dots RST in Fig. 3. An important feature is that the introduction of electrical energy having the waveform shown in the figure into living tissue causes an electric current in the tissue having the general nature shown in Fig. 4. As a result, the rapidly rising voltage will have an equally high value of the current induced in the tissue. Thus, with each voltage rise from a negative value to a positive value, as shown in Figure 3, there will be an equally high peak current. This is shown in Figure 4 by the points ABC. As the voltage slowly decreases from a positive to a negative value, a very weak current is passed through the tissue, as given by the points CD. In connection with the above, the rising current can either flow in the positive direction, as shown in Fig. 4, or it can rise in the negative direction, as in the swing voltage output signal when the voltage is rapidly negatively rising and then slowly positively rising, as reversed by the situation in the figure. Due to the above-mentioned phenomena, the intensity of the current caused by the load representing the zone of living tissue or object in the other direction is higher than in the opposite direction. This electric current naturally causes voltage differences in body tissue, and these differences are assumed to modify and alter voltages at the contact surfaces of cell membranes as well as the absolute value of the total voltage distribution along the predetermined tissue zone to be treated. Hard tissue, such as bone, is usually much deeper than muscle tissue or than substantial amounts of soft tissue, which usually comprises fluids found near the surface.

8 59203 An important feature of the present invention is that the current is made to flow in the tissue in which the tensions at the cellular level are to be modified. When the tissue in the form of a skeleton is deep below the surface of the body, the rise time of the voltage applied to the electrodes 50 and 52 must therefore be long enough to penetrate to the depth of the skeleton. This results in a frequency content in a portion of the input signal which, as given by the dots RST in Figure 3, corresponds to the constraints imposed by the electromagnetic skin effect on the penetration depth. The rise time indicated by the dots RST in the signal shown in Figure 3 and thus the frequency content is selected so that the signal is able to penetrate the deepest parts of the body to produce the voltage changes required at the cellular level according to the present invention.

For deep tissue, the maximum frequency content of the portion of the drive or activation signal indicated by the dots RST in Figure 3 may conveniently be in the range of about 10 Hz to about 10 kHz, corresponding to a rise time of about 0.1 seconds to about 0.0001 seconds. For tissue located quite deep, the frequency should be in the range of about 10 kHz to about 50 kHz, which corresponds to a rise time of about 100 microseconds to about 20 microseconds. For subcutaneous tissue, the frequency should be in the range of about 50 kHz to about 200 kHz, corresponding to a rise time of about 20 microseconds to about 5 microseconds, for skin tissue, the rise time should be in the range of about 200 kHz to about 1 MHz, corresponding to a rise time of about 1-5 microseconds. The activation signal should normally be in the form of a wave whose descent time differs from the rise time by at least one order of magnitude, i. at least a factor of 10.

In this connection, it should be noted that the limitations of the above-mentioned electromagnetic eddy current effect waveform rise time must correspond to the limitations imposed by the kinetic reaction rates of electrochemical processes occurring at the cellular level and necessary to achieve the desired therapeutic effect.

Although the descent time of the waveform shown in Fig. 3 is relatively long compared to the ascent time, it is to be understood that a descent time shorter than the rise time of the waveform may be used in the practice of the present invention. This is primarily because most of the penetration depth of the tissue-induced current generated during the descent period can be adjusted by adjusting the descent period to meet the constraints imposed by the electromagnetic eddy current effect at the penetration depth of the induced current. This prevents most of the induced current from reaching the tissue to be treated. In addition, the small portion of the induced current that actually penetrates the tissue to be treated can be maintained over a period of time shorter than necessary to inhibit cellular electrochemical processes that occur during the waveform rise time, and the desired therapeutic effect can be achieved by adjusting the waveform fall time.

Such descent times should be at least 10 times less than the ascent time and should generally also be less than 10 microseconds, which corresponds to a frequency above 100 kHz.

From the foregoing, it is to be understood that the particular method used may obtain various embodiments; the rise time of the activation signal may be different from the fall time, and the switching circuit shown in Fig. 1 is to be considered as an example only. More specifically, the frequency 0n of the torsion signals shown in Fig. 1 is proportional to the power supply voltage 23, the external load 24 applied to the circuit, and the values of the resistor 32 and the control resistor 30. Transistor 25 is of the NPN type, and transistor 26 is of the PNP type. Both transistors have normal emitter, collector and base electrodes. Transistor 25 conducts when power supply 23 charges capacitor 28 through resistors 30 and 32 so that the emitter-to-base connection in transistor 25 is loaded, with point 27 becoming positive and point 29 becoming negative. Resistor 31 is connected between the emitter of transistor 25 and point 35. Since the collector of transistor 25 is connected to the base of transistor 26, this in turn causes transistor 26 to conduct. When transistor 26 conducts, current flows through the primary winding 33 of transformer 34. The secondary winding 36 of the transformer 34 is connected so that the induced voltage further increases the input base current of the transistor 25. This self-amplifying effect rapidly increases the current flowing through both transistors 25 and 26 until both transistors become saturated. Transistors 25 and 26 remain saturated during the swing wave rise time during which capacitor 28 charges, so that point 29 receives a positive voltage and point 27 receives a negative voltage.

The rise time of the swirling waveform induced in this way is controlled primarily by the inductance of the transformer 34, the front resistor between the base of the transistor 25 and the emitter, and the capacitance of the capacitor 28. The rise time also depends to some extent on the capacitance of the capacitor 43 connected in series with the external load »

When the circuit illustrated in Figure 1 is continued to generate a pulsating output voltage, it can be seen that as the induced voltage in the secondary winding 36 begins to decrease, the current flowing through the base electrode of transistor 25 also decreases, which in turn reduces the base current in transistor 26. the current in the primary winding 33 decreases, which further reduces the induced secondary voltage in the winding 36. This latter self-amplifying effect rapidly changes the transistors 25 and 26 from the saturation state to the non-conducting state and then stops the rising part of the torsional wave. The voltage that developed across capacitor 28 during the pulse now reverses the emitter-base connection in transistor 25 at the voltage level at which capacitor 28 was previously charged. Capacitor 28 now discharges slowly through resistors 30, 32 and 31, and the supply of power thus causes a downward portion of the swirling wave. When the capacitor 28 is completely discharged, the charging cycle of the capacitor 28 is repeated through the resistors 30 and 32. The bioelectrochemical stimulation circuit of Figure 1 is characterized in that the frequency of signal generation is determined by the rate at which capacitor 28 reaches the fundamental voltage at which transistor 25 becomes conductive. Correspondingly, the values of the variable resistor 30, the fixed resistors 31 and 32, the power supply and the capacitor 28 can be considered as essential RC timing factors in the circuit which determines the operating period, i. the frequency of the swirling wave or pulse. As described above, the pulse frequency also decreases as the power supply voltage decreases. Also, any external load placed over capacitor 80 through capacitor 43 increases the time required for capacitor 28 to reach the voltage necessary to activate transistor 25, thereby increasing the frequency determining capacity of the circuit. Thus, the increase in external load is reflected in a decrease in the pulse frequency of the torsional waveform generated by the circuit. Accordingly, the pulse frequency of the signal generated by the circuit of Fig. 1 is inversely proportional to the sum of the rise time and the fall time of the formed pulsating waveform. Finally, in connection with the description of the circuit of Figure 1, it may be mentioned that diode 44 is needed to suppress the large negative voltage peak that develops across the windings of transformer 34 at the end of each pulse as a result of the energy generated by self-induction of transformer 34. If this is not suppressed, this voltage spike will inevitably damage transistors 25 and 26. Capacitor 40 reduces interference by suppressing magnetic signals that are too disturbed by the magnetically permeable core of the transformer and could otherwise cause the circuit of Figure 1 to trip prematurely. Lastly, it can be mentioned that the resistor 46 of 11 59203 operates in such a way that it eliminates the leakage currents I bQ of the transistors 25 and 26. If these currents are not removed during the inter-pulse period, these currents are reflected by the collector of transistor 26 and amplified by transistor beta. In particular selected transistors, this would increase the average amount of current dissipated by the circuit of Figure 1 by several percent at an operating temperature of 35-40 ° C.

Now that the general principles of the present invention have been described in conjunction with the capacitive reactive coupling of the embodiment shown in Figure 1, it will be appreciated that reactive coupling in the form of an inductive coupling may also be used. This is due to the fact that the living tissue is a conductive medium, as explained above. Correspondingly, a voltage loop or loop and the resulting induced current are generated in the selected zone when a magnetic flux having a rate of change is applied to the selected zone in the body being treated. When the rate of change in the second direction differs significantly from the rate of change in the other direction, a voltage and an electric current are induced in the selected zone, the current and voltage flow of which normally correspond to the flow shown in Fig. 1. Although those skilled in the art will appreciate how the magnetic flux can be altered to meet the requirements of the present invention, Figure 2 shows a system using an inductive coupling method to achieve this result.

Referring now to Figure 2, a comparison of Figure 1 shows that it differs from this in that in Figure 2 the electrode 50 has been replaced by induction devices or coils 50a and 52 and the electrode plate 52 is omitted, the input terminal 22 is connected to ground via line 56, and an added operational amplifier 47. The operational amplifier 47 is supplied with electrical power through a 68 volt power supply, as indicated in the drawing, which is required because the coils 50a and 52a require more power compared to the power requirements of the electrode plates 50 and 52 to connect similar voltage gradients to living tissue. The coils 50a and 52a are electrically connected in parallel, and although two coils are shown, their coils can also be used if one coil is desired to take advantage of the information of the present invention. Coils 50a and 52a are adjacent to and preferably in non-contact with load 25. Load 25 depicts the member of the patient being treated, as does load 24 in Figure 1 represented the member of the patient.

The electrical operation of the circuit of Figures 2 takes place in the same way as the circuit shown in Figure 1. Even the amplitude of the pulsating output voltage measured between terminals 12 59203 20 and 22 is the same as in Figs. 1 and 2 because the operation amplifier 47 is incorporated as a tracking operation amplifier in the circuit of Fig. 2.

In this regard, the following should be clarified: (1) There is a capacitive coupling between the electrode and the dissociated conductive medium, known as an electrical double layer capacitance. This capacitance can be used to transfer energy across the interface and provided that the voltage across this interface is less than or equal to the voltage at which the Faraday reaction occurs or the time to reach the reaction voltage is too short for the reaction to occur, this energy is transferred without Faraday interference to the electrode. and a conductive dissociated medium with which it is in contact. (2) Every dissociated or electrically conductive medium having an time-varying electromagnetic field caused by induction has an electrical eddy current. This current is caused by a voltage loop that always surrounds the magnetic flux »whose density of force lines changes over time. If, therefore, this medium is normally conductive, this induction can be used to transfer energy to the medium. (3) The efficiency with which electrical energy can be transferred to such a medium is directly proportional to the components of the maximum amplitude of the electrical signals present in the medium and in the conductivity of the medium. (4) The penetration depth of electrical energy is inversely proportional to the frequency components of the maximum amplitude of the electrical signals present in the medium.

Based on (1) and (3) and the knowledge that cells, tissues and body fluids contain dissociated and electrically conductive media, it has been shown that externally or artificially, normal activity or cell healing or tissue healing in a living subject can be stimulated, such as e.g. bone healing. As will be explained in more detail below, this is accomplished by generating a pulsating voltage between the electrodes mounted adjacent to, but not necessarily implanted in, the living tissue. The pulsating voltage, when applied to the tissue, creates an electric current through the tissue, which in turn causes a bipolar voltage in the tissue whose second pole amplitude and frequency components differ from the amplitude and frequency components of the opposite pole. This bipolar voltage is thought to cause the aforementioned bioelectrical signal that artificially stimulates tissue healing.

13 59203 This can be further observed without placing the electrodes in a living object and without causing a Faraday reaction at the interface between the electrodes and the body. A therapeutic effect can also occur in cells or tissue by placing electrodes directly on the surface of a living body, i. at the interface between the electrical conductor and the electrochemical conductor or with a dielectric substance placed between the electrodes and the body surfaces, i.e. at the interface between the carrier of the dielectric charge and the electrochemical conductor **, and according to (4) the transfer of electrical energy from the pulsating voltage source to the treatment areas is performed across or over the surfaces of the body. This is especially desirable when it is desired to promote the healing of broken bones or fractures.

Based on (2) and (3) and the fact that cells, tissues and body fluids contain dissociated and electrically conductive media, it has been shown that the normal activity or healing of cells or tissues in a living organism can also be stimulated externally or artificially, and that this can be achieved by generating a pulsating voltage over an induction device located adjacent to a living body. The induction device generates an alternating, time-varying electromagnetic field which, when connected to the tissue of a living body, produces a voltage loop which again induces an electric current through the tissue. The induced voltage thus causes a voltage in the tissue that is bi-polar and whose amplitude and frequency components at one pole differ from the amplitude and frequency components at the other pole. This bipolar voltage is again assumed to generate said working electrical signal which artificially stimulates tissue healing. As is the case with the use of electrodes to connect an electrical signal to the body, this can be achieved without contacting the induction device with the living tissue in question. That is, the therapeutic effect can occur in a cell or tissue living body when the induction device is used near but not in contact with the surface of the body in question, and according to (4) the electromagnetic energy is transferred to the treatment area again through or over the intervening tissue. This is still particularly desirable in promoting the healing of broken bones or fractures.

Reference is now made to Figures 3 and 4. As mentioned above, the discharge terminals 20 and 22 show a pulsating discharge voltage generated by the circuits of Figures 1 and 2 and shown by the swirling waveform shown in Figure 3. As mentioned, the amplitude of the output voltage generated by the circuit of Fig. 2 is the same as that of the voltage generated by the circuit of Fig. 1 14 59203, and further the waveform is substantially the same. For explanation, Figures 3 are also used with reference to Figure 2.

The waveform of the signals present in the external load of Fig. 1, namely the external load 24, is illustrated in Fig. 4. For explanation, Fig. 4 is also used with reference to Fig. 2. Therefore, the waveform of the signals present in the external load 25 is also illustrated in Fig. 4. therefore shows both current and voltage drop waveforms at loads 24 and 25, i. tissue level.

In Figure 3, the RSTU points give the complete waveform of the output voltage at terminals 20 and 22. The Fourier analysis of this waveform shows that at maximum amplitude the frequency components (fundamental frequency and first harmonic frequencies) are much higher in the RST part of the waveform than in the TU part.

In the circuit of Figure 1, the electrode plates 50 and 52, and in the circuit of Figure 2, the coils 50a and 52a are electrically connected to the output terminals 20 and 22 to provide an electric current at respective loads 24 and 25. The manner in which this electric current is provided in each case will be described in more detail below. It is evident from Figure 4 that at the tissue level, the electric current increases in the second direction from the intensity shown at point A to a relatively higher intensity at point B. The current then decreases to intensity C and continues at this intensity until point D, after which the cycle repeats. The fact that the current in the other direction is much higher than the current in the opposite direction means that either a substantially negative or a substantially positive voltage is generated in the living tissue zone, depending on how desirable it is to change the normal electrical voltage, and thus artificially stimulating tissue growth. The voltage present in the treatment zone, which can be either positive or negative, is determined by the polarity of the activation or operating signal with respect to electrodes 50 and 52 and coils 50a and 52a. For example, changing terminals 20 and 22 relative to electrodes 50 and 52 causes the signals shown in Figures 3 and 4 to be reversed. The fact that a small electric current flows in a direction that is not desired to change naturally occurring stresses or in a direction that inhibits tissue growth does not adversely affect the results of therapeutic treatment with an electric current that is many times larger than the opposite direction. current 59203. The voltage at the tissue level shown in Figure 4 can therefore be considered bipolar, and a current with a much higher intensity in one direction than in the other generates a voltage difference of much desired polarity when transmitting electrical signals to the living tissue or body shown in Figures 1 and 2. to avoid the necessary surgical conductive implantation of electrodes in the tissue being treated · The magnitude of this current is directly proportional to the values of the frequency components of the maximum amplitude of the waveform shown in Figure 3.

It follows from the above that the relatively higher values of the maximum amplitude frequency components in the part represented by the RST dots of the waveform shown in Fig. 3 appear in the current generated by the load (24 or 25) given by the ABS points in Fig. 4. This generated current whose waveform is ABC in Fig. 4 , the positive direction is reflected in the upward direction of the rate of change of the signal or operating waveform shown in Fig. 3. Correspondingly, the relatively low values of the frequency components at the maximum amplitude shown in the part of the waveform marked with dots TU in Fig. 3 are manifested in the low total intensity of the current generated at load 24 or 25, as given in dots C-D in Fig. 4. The negative direction of this generated current, the waveform of which is given by the points CD in Fig. 4, is reflected in the downward direction of the rate of change of the operating waveform shown in Fig. 3 *.

From the above, it is to be understood that the current generated by the loads 24 and 25 is obtained in such a way that it reflects the relative values of the maximum amplitude frequency components, as shown in Figure 3. That is, the Fourier analysis of the waveform of Figure 4 shows that the maximum amplitude frequency is much higher in the part of the waveform given by points ABC than in the part given by points CD. Furthermore, it can be seen from Figure 4 that a voltage is generated at the tissue level which is bipolar and whose amplitude and frequency components at one pole differ from those at the other pole, and that The maximum amplitude of the 4 signals is in point B.

Referring again to Figure 1, the placement of the electrodes with respect to the desired treatment zone or injury is such that the electrode with the highest current density, i. the smallest electrode, is mainly the area where therapeutic treatment is desired. According to the present invention, and in order to promote bone growth, this electrode is the electrode in which the maximum frequency components travel in the negative direction, i. electrode 52 16 59203 is selected as the smaller of the electrodes. Hereinafter, the d.electrode 52 is occasionally referred to as a working electrode. The second electrode, electrode 50, hereinafter referred to as the counter electrode, is formed for a minimum current density, which, as will be explained later, avoids the counteracting effect of this electrode and minimizes side effects such as nerve damage, taking into account optimal voltage distribution. Electrodes 50 and 52 may be formed of either a conductive or semiconducting material. The requirements for electrode materials are: (1) that it does not react with the skin and, for example, cause infection or rash, (2) that it is not polarized so strongly that healing cannot occur in the presence of body fluids, but that the desired signal energy and frequency content is available at the right point at the cellular or tissue level.

The recommended material for forming the electrodes 50 and 52 is silver, but other suitable materials may be used.

It should be noted here that the electrodes 50 and 52 may be placed in direct physical contact with the epithelial surfaces of the body to be treated, in which case such physical contact may be an electro-electrochemical interface, or a suitable dielectric material such as myary or even air may be placed in the electrodes. and between the epithelial surfaces of the body, in which case such physical contact is a di-electro-electrochemical interface.

In the case of an electro-electrochemical interface, the maximum voltage or time at which it is applied to a particular electrode is selected in accordance with the teachings of the present invention so as to avoid Faraday reactions. Measured between electrodes 50 and 52, the maximum voltage applied between electrodes 52 and 50 is suitably in the range of about 0.8 volts to about 1.0 volts in the positive direction and in the range of about 0.0 volts to about -0.01 volts in the negative direction.

These Faraday reactions may involve local changes in pH, local changes in pressure (so-called osmolality), changes in essential proteins, lipids, etc. destruction or electrolysis in physiological saline, resulting in the evolution of the gas qualities contained therein (Κ ?, Cl? or 0?).

17 59203

If an unusually undesired high voltage has to be applied to the working electrode, i.e. more than about 1 volt to achieve the desired healing in the tissue zone, tissue microsis or other detrimental tissue effects can be avoided by keeping the working electrode at this abnormally high voltage for less than the time required for Faraday reactions to occur. The exact upper limit of time depends on the voltage drop across the interface between the drive electrode and the tissue.

This latter voltage drop is not directly measurable. However, a measurable voltage drop between the working electrode and the reference electrode can be obtained. This measurable voltage drop consists of two components, namely the voltage drop across the working electrode-tissue interface responsible for the presence of Faraday reactions and the voltage drop caused by the voltage drop across the tissue between the working and reference electrodes, respectively. Therefore, the upper limit of time allowed, expressed as the voltage to be measured, depends on the following factors: the area and geometry of the working electrode, the geometry of the tissue and the conductivity between the working and reference electrodes, all of which determine the voltage drop across this tissue volume. The voltage drop due to the impedance of tissue and body fluids when subtracted from the vector measured voltage drop between the working and reference electrodes gives a voltage drop across the interface between the working electrode and the tissue. The latter voltage drop in turn determines the main electrochemical reactions at this interface and thus also their kinetic reaction rates. Their speeds in turn determine the maximum time, i. an upper limit to the time at which a drop in the working electrode voltage may be allowed to be greater than a voltage drop that causes Faraday reactions at the interface between the working electrode and the tissue over a long period of time. When the voltage of the drive electrode is about 1 volt to about 100 volts, respectively, measured with respect to the reversible hydrogen electrode (RHE) in the same electrolyte, i. in tissue, the drive electrode can suitably maintain these voltages for about 500 microseconds to about 1 nanosecond in the drive electrode area of 1 cm, respectively, before harmful Faraday reactions occur at the drive electrode-tissue interface.

When the voltage of the drive electrode is about -0.01 volts to about -100 volts, respectively, measured with respect to RHE in the same electrolyte, i. in tissue, respectively, the working electrode may persist at these potentials for about 500 microseconds to about 1 nanosecond with a working electrode area 2 of 1 cm before harmful Faraday reactions occur at the interface between the working electrode and the tissue.

18 59203

In summary of the above and in accordance with the present invention, it can be shown that Faraday reactions are avoided in the case of an electro-electrochemical interface at too high a voltage applied to the electrode-tissue interface for a time not exceeding 500 microseconds. . . 2 about 1 nanosecond per cm of electrode dip because the time constants of said Faraday reactions are much longer than the time constants associated with charging and discharging double layer capacitances. When this time or frequency limitation cannot be used, according to the present invention, it is necessary that the voltage measured between the working electrode and the RH electrode in the same electrolyte (tissue, amplitude does not exceed +0.8 to +1.0 volts in the positive direction) or about 0.0 to about -0.1 volts measured between the working electrode and the reference hydrogen electrode in the same electrolyte in the negative direction to avoid the above-mentioned Faraday reactions.These voltage limits apply to those electrodes, i.e. platinum group metals, in which ions do not enter the solution to a significant extent , when the voltage is changed from the normal resting or constant voltage of the electrode, a narrower, i.e. more limited, voltage range must be used for most other types of electrodes.

In the case of the dielectric-electrochemical interface, there is no problem with the epithelial surfaces of the body caused by Faraday reactions.

Referring again to Figures 1,3 and 4, the pulsating output voltage generated by the circuit of Figure 1 occurs between the output terminals 20 and 22 and, as described above, is illustrated by the swirling waveform shown in Figure 3. The pulsating output voltage is capacitively or alternately connected to the electrodes 50 and 52 through the capacitor 43. This connection ensures that no DC components are present at terminals 20 and 22. The capacitor 43 can be omitted in cases where there is a die material between the electrodes 50 and 52 and the associated surfaces, because in each case the electrode, the dielectric material and the body surface effectively form a capacitor. The capacitor thus formed effectively blocks the direct current components.

Typically, a current, the waveform of which is shown in Figure 4, is generated at the tissue level when the output voltage at terminals 20 and 22 is placed over a capacitor in series and / or in parallel with the impedance. The capacitor consists of a double layer of capacitor formed between the electrode plates 50 and 52 placed on the surfaces of the body and the dissociated substances of the tissue fluids. Impedance is the impedance of tissue to the passage of ions through tissue and all other related electrochemical events, i. redox events, adsorption and desorption events. At the tissue level, the bipolar voltage whose voltage drop waveform is shown in Figure 4 is the result of the voltage drop that the current causes across the impedance of the tissue and body fluids.

The device shown in Figure 1 is assumed to operate for the purpose shown because the generated bipolar voltage at the tissue level, peak Y of which is shown in the figure, is higher in current intensity and amplitude than required to generate the desired stimulation during the rising pulse, i. greater than is required to generate a working electrical signal. The intensity and amplitude of the bipolar voltage given by the points CD in Figure 4, both generated at the tissue level, are below the levels required to provide stimulation, i. below the level that produces the working electrical signal.

As a result, the electrode plate 50 or 52, which is closest to the desired treatment zone, will be either negative or positive for nearby cells or tissue. This result is achieved despite the fact that the average current flowing through the system is zero. The following explains in more detail the preselection of the region for electrodes with positive or negative polarity with respect to foreign body surfaces. Usually, however, one of the electrode plates 50 or 52 is placed closer to the desired treatment zone than the other electrode plate. Electrode plates 50 and 52 are best located adjacent to the living tissue or epithelial surfaces of the patient being treated. The word "adjacent" as used herein means proximal, restrictive, tactile, or related, for example, when plates 50 and 52 are in direct physical contact with body surfaces, they contact body surfaces, with the plates adjacent to or near body surfaces, i.e., in close proximity; wherein the di-electrical substance is placed between the plates and the body surfaces.

However, it will be appreciated that the electrodes 50 and 52 may also be configured to be implanted in the treatment zone. That is, both electrodes may be formed as needle electrodes, or alternatively, one may be formed as a needle and the other as an electrode plate. However, as mentioned, the electrodes are best located outside the epithelium of living tissue. A non-intrusive method is preferred because in this way the signals generated in Figure 1 can be coupled to the treatment zone without causing discontinuity in the epithelium, thereby avoiding the risk of superficial or deep infection in the patient being treated.

In this connection, it should also be clarified that although the preferred form of the power source 23 is a battery with one or more electrochemical cells, other suitable known sources of electrical power can also be used. If desired, the entire circuit in Figure 1 can be poured into its casting mass, which is compatible with the environment of the body, with or without the construction of a power supply. In the latter case, the power source may be electrically connected to the electrical circuit by suitable terminals mounted on the casting. This makes it possible for the batteries to be replaced during treatment if necessary and for the electrical components of the circuit to be reused, which would not normally be the case if the batteries were molded together with the components in the manufacture of the circuit of Figure 1. Further, one of the electrodes 52 or 50 may be formed as a plate attached to the casting surrounding the electrical components. In this case, the plate would, of course, be suitably connected to the electronics inside the casting. Accordingly, one or both of the electrodes 50 or 52 may be formed as a spatula, spatula wall, gypsum light, or bandage surrounding the treatment zones. In this connection, it should also be mentioned that the circuit according to Figure 1 can also be cast or embedded in a material which does not affect those substances, nor which substances themselves do not affect this material, which is used in the light of broken or broken members or other body members. The reason for this is that the circuit of Figure 1 may, if desired, be immersed in light to secure or support a member or other part of the body with a fractured or broken bone.

The molded or embedded circuit of Figure 1 may also be completely implanted in the body of the patient being treated, if desired. In the latter case, a coating of silicone rubber or a similar material can also be used. That is, a paper-thin shell of silicone rubber may be formed around the embedding material. The coils 50a and 52a shown in Figure 2 can be formed of any conductive or semiconducting material. The main requirements for coils are: (1) that they be placed so that they do not necessarily touch the surfaces of the body in question and that the associated electromagnetic field, when changed, generates voltage loops and induces eddy currents in the desired areas, and 21 59203 (2) that coils are formed of a material that does not apply excessive impedance to the electric current with the voltage gradients normally present in this circuit.

The preferred embodiment of coils 50a and 52a is silver, although other suitable materials such as copper may be used.

The coils are best positioned with respect to the injury so that smaller electromagnetic force lines pass through the injury area at right angles to the recommended current direction, as will be explained in more detail below. These coils are also best formed and positioned to dissipate the current, i. reduce current density in areas of the body or surrounding tissue that are not in the immediate vicinity of the injury area to reduce potential side effects, such as negative healing.

Reference is now made to Figures 2, 3 and 4. As mentioned in the circuit of Figure 2, there is a pulsating output voltage between terminals 20 and 22, which is illustrated by the swirling waveform shown in Figure 3. As mentioned above, the amplitude of the output voltage caused by the circuit of Fig. 2 is the same as the amplitude caused by the circuit of Fig. 1. In addition, the waveform is substantially similar, and Figures 3 and 4 are again used to clarify this, but with reference to Figure 2 here. The pulsating output voltage is capacitively connected to the operational amplifier 47 via a capacitor 43. In fact, the capacitor 43 can be omitted from the circuit of Fig. 2, if desired, because no DC components can occur in the load 25, since in this case the output voltage is inductively connected to the load 25.

As a result of the pulsating output voltage or vortex waveform being applied over the coils 50a and 52a, a pulsating current is generated in the coils 50a and 52a which produces a pulsating, time-varying electromagnetic field load in the vicinity 25, i. a modulated electromagnetic and torsionally field-shaped field coupled to the load 25 by positioning the coils with respect to the load 25.

The waveform of the signals present at load 25 is illustrated in Figure 4, as mentioned above. The waveform illustrated in Figure 4 shows the voltage rise and the waveforms of the induced current at the tissue level. It will be appreciated by those skilled in the art that the remarks made above with respect to the waveforms 22 59203 of Figures 3 and 4 regarding the bipolarity of the voltage present at the load and from the Fourier analysis of these waveforms may be applied,

Typically, a voltage loop is generated at the fabric level by placing a modulated sink-wave electromagnetic field generated by coils 50a and 52a across the fabric perpendicular to the desired current direction at the fabric level. This voltage loop generates a current which in turn produces bipolar tension at the tissue level. The decrease in voltage and the current waveform shown in Figure 4 are the result of a decrease in voltage caused by the current flowing across the impedance of the tissues and body fluids.

The device according to Fig. 2 is believed to fulfill said purpose, since the amplitude of the bipolar voltage generated at the tissue level (sharp tip B in Fig. 4) in the rising part X of the swirling wave in Fig. 3 is greater than that required to generate a bioelectric signal. The magnitude of the current and the amplitude of the bipolar voltage shown by the dots CD in Fig. 4, which is generated at the tissue level during the decay of the torsional wave, i.e. in the decreasing part Z of Fig. less than the level required to produce the working electrical signal. As a result, in the intervening cells, a voltage drop across the tissue occurs as a tissue-related polarity, i. one end or part of the zone to be treated appears to be positive with respect to the intervening cells, but the other end or part appears to be negative, although the average current flowing through the system is zero.

It should be mentioned here that the coils 50a and 52a are usually positioned with respect to the desired stimulation zone so that the electromagnetic field strength becomes maximum in this zone. The coils 50a and 52a are best placed next to, but not necessarily in contact with, the skin surface of the patient to be treated. · However, the coils 50a and 52a may be formed so that they can be placed over the patient's skin or implanted in the treatment zone. Both coils can be formed as connected coils with tapered edges, or alternatively the geometry of the other coil can be as mentioned above, but the other coil can be made into a small ferrite core inductor.

59203 23 In this connection, it should also be mentioned that the power source 23 and the 68 volt power supply for the operating amplifier 4-7 are a battery or accumulator which either comprises one or more electrochemical cells. If desired, other suitable electrical power sources can be used. If desired, the entire circuit of Figure 2 can be cast into an implant that is compatible with the body environment (including the human body), with or without a built-in power source. In the latter case, the power source is electrically connected to the electrical circuit by suitable terminals placed in the casting. This allows the batteries to be replaced during treatment if necessary and also that the electrical components of the circuit can be reused, which would not normally be the case if the batteries were embedded with the components that make up the circuit of Figure 2. In addition, the coils 50a and 52a may each be formed as a coiled coil attached to a casting surrounding the electrical components. In this case, the coils can, of course, be suitably connected to the electronics inside the encapsulation tank. Both coils 50a and 52a may likewise be arranged in the form of a spatula, spatula wall, light or bandage surrounding the damaged area. In this connection, it should also be noted that the circuit of Figure 2 may also be molded or embedded in a material compatible with the environment in the materials used to form the lights for broken or broken members and other parts of the body. This is because the circuit in question may, if desired, be immersed in light intended to be held in place or supported by a member or other part of the body with a broken or fractured bone.

The encapsulated circuit of Figure 2 can also be completely implanted in the patient's body if desired. In the latter case, a coating made of silicone rubber or other similar material can also be used. That is, the material to be embedded may be surrounded by a thin silicone rubber shell.

However, as mentioned, the coils are best placed outside the epithelial surfaces of the body, as a non-invasive surgical procedure is preferred for applying electrical energy to living tissue using the principles of the present invention.

To date, the therapeutic treatment of bone tissue has been emphasized as a concrete example of the use of the method and apparatus of the present invention. Of course, it is to be understood that the bioelectrical activity of cell membranes can be regulated externally. Therefore, the bioelectrical method and apparatus of the present invention in all embodiments and related variations thereof can be used to provide effective stimulation or a curative effect in the following areas: (1) Growth (2) Regeneration and repair (3) Regeneration (4) Malignant conditions (5) ) Therapeutic pain control (6) Therapeutic muscle and nerve control (7) Infection These potential uses are given by way of example and not limitation. These potential uses mean that the method and apparatus of the present invention are likely to be used in areas such as bone repair or fracture healing, cancer prevention, limb regeneration, soft tissue and thrombosis healing. In other words, all biological processes in which electrical behavior is not normal are affected by a properly programmed bioelectrical method or device. A properly programmed work-electrical method or device in this context comprises those methods and devices for generating a pulsating waveform output voltage having a rise time different from its fall time and in which the output signals can be programmed by generating the device in a certain frequency range.

With respect to the circuits of Figures 1 and 2, the term properly programmed therefore means that it includes changes in frequencies, operating cycles, waveform rise times, waveform decay times, and also in the polarity of the output voltage generated by the circuits of Figures 1 and 2. Those skilled in the art will recognize that these factors determine the output voltages generated by the circuits of Figures 1 and 2. Changes in duty cycles, rise time, and frequency can be accomplished by changing resistor 30, capacitor 28, and power source 23. In terms of fall time, changes can be made by changing the inductance of transformer windings, e.g., changing transformer, and polarity changes can be made by reversing transmission lines 54 and 55 in the circuit of Figure 1 or transmission lines 54 and 56 in the circuit of Figure 2.

In the case of the circuit of Figure 1, properly programmed also means that it includes the placement of the electrode plate area and the geometry of the electrode plate. In other words, these latter factors control the intensity and area through which energy is transferred from the circuit of Figure 1 to a specific zone of living tissue to be treated. In the case of bone healing, wound healing, and tissue regeneration, for example, in the preferred embodiment, the placement of the electrode plates is such that the operating or negative electrode plate 52 is on the treatment area and the counter or positive electrode plate 50 is placed on the area where any inverse or the opposite effect with respect to the desired effect is either detrimental or cannot or does not occur. Typically, the area of the working electrode or electrode that provides the desired stimulation or healing effect is about 1/5 of the area of the counter electrode or opposing electrode plate, and the shape of the electrode plate is selected so that the electric field is concentrated as close to the desired treatment area as possible. When it comes to reversing cancer, disrupting or destroying unwanted or unwanted tissues, the same criteria can be used for plate shape, geometry, etc. however, it is assumed that the polarity of the electrode strips should be reversed, i. electrode plates should be placed in contrast to healing bones, wounds and tissue regeneration.

In the case of the circuit of Figure 2, "properly programmed" means that the term includes placement, coil volume, and coil geometry, the latter parameters controlling the intensity and range over which energy is transferred from the circuit of Figure 2 to the tissue zone of the living tissue being treated. that the maximum field strength, i.e. the maximum flux density, is as close to the desired treatment area as possible.

Figure 5 shows an electromedical device of the type shown in Figure 1 and the patient for which it is used, the parts of the patient being shown schematically. The drive electrode or negative electrode 52 is close to the area to be treated, and the counter electrode, i.e., the positive electrode 50, is located away from the area to be treated. Box 10 is marked with a circuit that can generate an electrical signal that pulses in both the positive and negative directions and whose waveform rise time differs from the fall time. Such an arrangement generates a current in the portion 102 of the patient to be treated during the pulsation of the electrical signal generated by the circuit of the box 100. The intensity of the current is higher when moving from the vicinity of the part 102 to the area of the part further than in the opposite direction. The magnitude of the stronger current corresponds to the current signal given by points ABC in Fig. U, and the smaller amount of current flowing from the distal region 26 59203 to the vicinity of portion 102 corresponds to the current signal given by points CD in Fig. 4. As a result of this current, a bipolar voltage is generated in and over the treatment zone, which oscillates in both positive and negative directions so that the maximum amplitude of the bi-polar voltage in the other direction is greater than the maximum amplitude of the bipolar voltage in the opposite direction, i. corresponds to the voltage drop waveform in Figure H. The bipolar voltage thus stabilized in the treatment area is for the most part negative in polarity, increasing the absolute value of the naturally occurring electrical voltage in the treatment zone, and this bipolar voltage is assumed to be cumulative. the recovery rate is higher.

Figure 6 shows an electromedical device of the type shown in Figure 1 and the patient in which it is used, the parts of the patient being shown schematically. The figure illustrates one fcela 202 positioned over the treatment area as close to the treatment area as possible. Box 200 shows a circuit that can generate an electrical signal that pulses in both the positive and negative directions and whose waveform rise time differs from the fall time. The arrangement shown in Figure 6 generates a pulsating current in the coil 202, which in turn provides a pulsating time-varying electromagnetic field which, due to the position of the coil 202 relative to the patient portion 102, is coupled to the portion 102 during pulses of the drive signal. At the tissue level, a voltage loop is generated, which in turn provides a current to the portion 102, which in turn causes a bipolar voltage in and over the patient portion 102. The electromagnetic field generated by the coil 202 is perpendicular to the desired current directions, and the current pulses in both the negative and positive directions in the patient section 102. The current flowing from the vicinity of the section 102 to the distal portion of the section 102 is greater than the distance from the remote section 102 from the area to its vicinity. The higher current corresponds to the current signal given by dotted ABC in Figure 4, and the lower current corresponds to the current signal given by dots CD. As a result, a bipolar voltage is generated in and over the treatment zone, which oscillates in both the positive and negative directions, whereby the maximum amplitude of the bipolar voltage in the other direction is greater than the maximum amplitude of the bipolar voltage in the opposite direction, i. corresponds to the voltage drop waveform in Figure 4.

27 59203

The polarity of the bipolar voltage thus generated in the treatment area is for the most part negative, increasing the absolute magnitude of the naturally occurring electrical voltage in the treatment zone, and this bipolar voltage is assumed to be cumulative with the naturally occurring voltage change promoting and accelerating the recovery mechanism.

Although electronic circuits have been mentioned so far, those skilled in the art will appreciate that a mechanical device capable of generating either a pulsating electrodynamic or electromagnetic field that rises and falls at a preselected frequency and that the field rise time differs from that of the present invention. current. Such a mechanical device is shown schematically in Figure 7, in which the magnet 302 rotates about an axis 304. The member 306 is a plate of a material through which the magnetic field of the rotating magnet 302 does not penetrate, and the member 306 has a three-edged hole 308. Those skilled in the art will appreciate that when the poles of the magnet 302 rotate past the hole 30, an electromagnetic field is generated on the other side of the member 306. and calculates the magnet 302 according to the rotational speed. In addition, the rise time of the generated magnetic field is different from the fall time due to the three-edged hole 308.

It will be recalled that the broadest area of the present invention is the treatment of living cells by taking advantage of the properties of the contact surfaces of the cell membranes, which means that the cell membranes act as electrodes. Accordingly, the membranes respond to local voltage changes. Although neurons, due to their specific structure and specific sensitivity, may be the cells most affected by the described local electrical voltages, the present invention is not only intended to stimulate neurons, although this may be a necessary step in healing but also to stimulate other susceptible cell or tissue species. if so necessary to achieve the desired results in the form of healing or regeneration of the desired tissue types, or alternatively in the possible degradation or destruction of unwanted or unwanted tissues.

Although the accompanying description has been made with respect to the specific mechanical phenomena associated with cell and tissue healing, it is to be understood that in many areas such actual events are not yet fully known. The above has only attempted to clarify the fact that the described device can be used for said purposes.

28 59203

In a practical embodiment of the present invention, the components mentioned in connection with the figure may have the values given in Table I; Talukko I

Resistance (ohms) 30 ....................... 0-1000 kilo ohms / control.

31 ....................... 50 kilo-onmi 32 ..................... ..50 "" 46 ....................... 500 ""

Capacitor (microfarad) 28 ....................... 0.047 40 .................... ... 0.0047 43 ....................... 1.0

Transistor

25 ....................... 2N718A

26 ....................... 2N3217

Transformer 34 ........................ United Transformer Corp.

♦ Bit-250-48

Diodes 44 ....................... Hewlett Packard HP2800

In a practical embodiment of the present invention, the components described in connection with Figure 1 may have the values given in Table 2; Table 2

Answer (ohm) 30 ........... ...... 0-1000 kilo-ohm, adjustable.

31 ....................... 50 kilo-ohms 32 ..................... ..50 kilo-ohm 46 ....................... 500 kilo-ohm

Capacitor (microfarad) 28 ....................... 0.047 40 .................... ... 0.0047 43 ....................... 1.0

Transistor

25 ....................., .2N718A

26 ....................... 2N3217

Transformer 34 ....................... United Transformer Corp. ^ Bit-250-48

Diodes 44 ....................... Hewlett Packard HP2 800

Operating amplifier 47 ....................... RCA HC 2000

Claims (7)

An electromedical apparatus for the therapeutic treatment of cells and / or living tissue within a predetermined zone of a living body, comprising an apparatus for generating a road-shaped electrical signal, characterized in that the signal generating device is arranged to be or is adjustable to generate a driving signal (Fig. 3) with a road shape where the tide's fall time (TU) differs at least tenfold from its rise time (RST) and the apparatus further comprises means for reactively coupling the driving signal to the predetermined zone of known in itself. 2. Apparatus according to claim 1, characterized in that said coupling means comprise capacitive coupling means, such as a pair of spaced electrode plates (50, 52). Apparatus according to claim 2, characterized in that one of said electrode plates has a surface which is considerably larger preferably about 5 times larger than the surface of the other electrode plate. 4. Apparatus according to claim 2 or 3, characterized in that the electrodes are arranged to or are designed to be placed in direct physical contact with the epithelial surfaces of said body to be treated. 5. Apparatus according to claims 1 and 4, characterized in that said signal generating device is arranged or adjustable to deliver a driving potential to said electrode plates for a period of time not exceeding about 500 µs to about 1 nanosize 2 per cm of electrode surface. 6. Apparatus according to claim 1, characterized in that said coupling means comprise inductive coupling means, such as at least one coil (202) or two electrically parallel coupled coils (50a, 52a). Apparatus according to any of the preceding claims, characterized in that said single generated device is adjustable to deliver rise times of about 0.1 s down to about 1 us.