Patent Publication Number: US-8112156-B2

Title: Method and device for improving blood flow by a series of electrically-induced muscular contractions

Description:
This application claims priority from U.S. patent application Ser. No. 10/451,334 filed 20 Jun. 2003, which claims priority from PCT/IL02/00035, filed 16 Jan. 2002, which in turn claims priority from Israeli Patent Application No. 140950, filed 17 Jan. 2001. 
    
    
     FIELD AND BACKGROUND OF THE INVENTION 
     The present invention relates to a method of enhancing blood flow, and more particularly, to a method of promoting a localized increase in the flow of blood through a blood vessel by inducement of a repeated, contracting movement of muscular tissue associated with the blood vessel, the inducement being achieved by subjecting the muscular tissue to an electric current. This repeated, contracting movement of muscular tissue creates a peristaltic motion of the blood vessels, thereby increasing the flow of blood. Alternatively, the repeated, contracting movement of muscular tissue can be induced against the flow of blood, such that the flow of blood to a given area is reduced. 
     The method presented herein is germane to a wide variety of medical applications, including various problems associated with poor blood circulation, improved drainage of retained water, relief of muscle and tissue pain, and therapy related to controlling the functioning of erectile tissue. The stimulation of blood flow is of particular importance for the treatment of sores on extremities and/or in organs suffering from poor blood circulation, e.g., increasing the flow of blood to the toes of a diabetic patient, or increasing the rate at which an edema is drained from a body cavity. The restriction of blood flow is also germane to a wide variety of medical applications, including various surgical procedures. 
     Current treatments for improving blood circulation and alleviating neural and muscle pain include manual, electrical, and mechanical methods. Manual treatment practiced in physiotherapy requires massage administered by qualified personnel. This art varies according to the experience and technique of each individual massage therapist, and therefore can not be prescribed in an adequately standardized form. The improvement in blood circulation is also of an extremely limited magnitude. 
     Electrical Muscle Stimulation (EMS) has seen widespread use in many applications. The Food and Drug Administration (Section 355.200 Electrical Muscle Stimulators, CPG 7124.26) maintains that EMS devices are recognized in the health care community as being effective for muscle reeducation, relief of muscle spasm, increasing range of motion, disuse atrophy therapy, increasing local blood circulation, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. It must be emphasized, however, that the stimulation provided by EMS is very similar to the stimulation achieved by therapeutic massage. The increase in blood circulation is so modest that it is often undetectable using conventional flow-measuring equipment such as Doppler-based equipment. EMS is a random excitation of a local tissue area. Hence, EMS methods, like therapeutic massage, hot-water treatments, etc. are incapable of providing a major increase in the localized flow of blood. Moreover, because the excitation is random, EMS methods are fundamentally incapable of providing a decrease in the localized flow of blood. 
     Also known is a sequential pneumatic device for the reduction of an edema. The device consists of several overlapping compartments contained in a sleeve assembly. The compartments are inflated in a sequential fashion, from a distal end disposed adjacent to the edema, to a proximal end, such that the edema is pressed in the proximal direction. Each compartment is filled with air by a pump. The cycle starts with the filling of the distal compartment, and subsequently the remaining compartments are filled until all compartments are full. After a deflation period, the cycle is repeated. 
     In such electromechanical installations, electric motors, reciprocating mechanisms and the like create uncomfortable noise and vibration. These treatments are of further disadvantage in that they require various device elements to be contacted with the skin. These elements are often a source of discomfort to the patient, and require changing and cleaning after each use in order to ensure good sanitary conditions. 
     There is therefore a recognized need for, and it would be highly advantageous to have, a method for promoting, regulating, and/or decreasing the localized fluid circulation through blood vessels, according to demand. It would be of further advantage if such a method would be simple, user-friendly, non-invasive, repeatable, and adjustable to the individual needs of the patient. 
     SUMMARY OF THE INVENTION 
     According to the teachings of the present invention there is provided a treatment method for promoting a localized increase in a flow of blood through a blood vessel in an area of a body, including the steps of: (a) providing a system including: (i) at least a first electrode operatively contacting a first portion of body tissue; (ii) at least a second electrode operatively contacting a second portion of body tissue, and (iii) a signal generator, operatively connected to the first electrode and the second electrode, for providing a plurality of electrical impulses to the electrodes; (b) applying the electrical impulses so as to subject the muscular tissue to at least one voltage differential, thereby inducing a repeated, contracting, directional movement of muscular tissue associated with the blood vessel, so as, to produce a localized increase in the flow of blood through the blood vessel. 
     According to another aspect of the present invention there is provided a treatment method for promoting a localized change in a flow of blood through a blood vessel in an area of a body, including the steps of: (a) providing a system including: (i) at least a first electrode operatively contacting a first portion of body tissue; (ii) at least a second electrode operatively contacting a second portion of body tissue, and (iii) a signal generator, operatively connected to the first electrode and the second electrode, for providing a plurality of electrical impulses to the electrodes, and (b) placing the at least a first electrode at one end of the area, and placing the at least a second electrode at a second end of the area, and (c) applying the electrical impulses so as to establish a voltage differential between the electrodes, the voltage differential being made up of two wave forms propagated in opposite directions between the electrodes, so as to produce a localized change in the flow of blood through the blood vessel. 
     According to another aspect of the present invention there is provided a treatment method for promoting a localized decrease in a flow of blood through a blood vessel in an area of a body, including the steps of: (a) providing a system including: (i) at least a first electrode operatively contacting a first portion of body tissue; (ii) at least a second electrode operatively contacting a second portion of body tissue, and (iii) a signal generator, operatively connected to the first electrode and the second electrode, for providing a plurality of electrical impulses to the electrodes, and (b) applying the electrical impulses so as to subject the muscular tissue to at least one voltage differential, thereby inducing a repeated, contracting movement of muscular tissue associated with the blood vessel, so as to produce a localized decrease in the flow of blood through the blood vessel. 
     According to yet another aspect of the present invention there is provided a device for promoting a localized change in a flow of blood through a blood vessel, the device including: (a) at least a first electrode operatively contacting a first portion of body tissue; (b) at least a second electrode operatively contacting a second portion of body tissue, and (c) a signal generator, operatively connected to the first electrode and the second electrode, for providing a plurality of electrical impulses to the electrodes, and (d) control means for controlling signals produced by the signal generator, wherein the control means and the signal generator are designed and configured, and the electrodes are displaced, so as to establish a voltage differential between the electrodes, the voltage differential being made up of wave forms propagated in opposite directions between the electrodes, the voltage differential for promoting a localized change in the flow of blood through the blood vessel. 
     According to features in the described preferred embodiments, the electrical impulses act upon the muscular tissue to produce a periodic, repetitive, undulating motion that imposes on the blood vessel a repetitive periodic motion of peristaltic character. 
     According to still further features in the described preferred embodiments, the first electrode is a first plurality of electrodes, the second electrode is a second plurality of electrodes, and the providing of the localized increase in the flow of blood is achieved by spacing the electrodes of the first plurality and of the second plurality along a length of the area and establishing sequential and repetitive voltage differences between the electrodes of the first plurality and the electrodes of the second plurality. 
     According to still further features in the described preferred embodiments, the method further includes the step of: (e) placing the first electrode at one end of the area, and placing the second electrode at a second end of the area, and wherein the voltage differential established between the electrodes is made up of two wave forms propagated in opposite directions so as to obtain a resultant signal of defined direction, frequency and strength whereby the repeated contracting movement of muscular tissue is induced. 
     According to still further features in the described preferred embodiments, the first electrode is a single first electrode, and the second electrode is a single second electrode. 
     According to still further features in the described preferred embodiments, the method further includes the step of: (c) optimizing the localized increase in the flow of blood. 
     According to still further features in the described preferred embodiments, the optimizing is based upon sensory controlled adjustment. 
     According to still further features in the described preferred embodiments, the optimizing is performed based upon instrumentally measured blood flow. 
     According to still further features in the described preferred embodiments, the method further includes the step of: (c) obtaining a periodic measurement of the flow of blood through the blood vessel, and (d) optimizing the localized increase or decrease in the flow of blood based upon the measurement. 
     According to still further features in the described preferred embodiments, the method further includes the step of: (c) modulating a parameter of a wave signal established across the first electrode and the second electrode. 
     According to still farther features in the described preferred embodiments, the parameter of the wave signal includes a frequency of the wave signal. 
     According to still further features in the described preferred embodiments, the parameter of the wave signal includes a form of the wave signal. 
     According to still further features in the described preferred embodiments, the parameter of the wave signal includes a voltage of the wave signal. 
     According to still further features in the described preferred embodiments, the method further includes the step of: (c) modulating a parameter of the repeated contracting movement to achieve defined target characteristics for the flow of blood. 
     According to still further features in the described preferred embodiments, a pressure sensor is utilized to measure or indicate the blood flow. 
     According to still further features in the described preferred embodiments, the method further includes the step of: (c) synchronizing the plurality of electrical impulses with pulses of blood corresponding to heartbeats, to obtain the localized increase in the flow of blood. 
     According to still further features in the described preferred embodiments, the synchronizing is achieved by monitoring blood pressure in the body. 
     According to still further features in the described preferred embodiments, the signal consists of a positive voltage differential phase and a negative voltage differential phase, wherein the positive phase and the negative phase have a time overlap. 
     According to still further features in the described preferred embodiments, the time overlap is between 1 microsecond and 500 microseconds. 
     According to still further features in the described preferred embodiments, the time overlap is between 10 microseconds and 100 microseconds. 
     According to still further features in the described preferred embodiments, the signal consists of a plurality of positive voltage differential peaks and a plurality of negative voltage differential peaks, wherein each of the peaks has a duration of 30-500 microseconds. 
     According to still further features in the described preferred embodiments, each of the peaks has a duration of 50-300 microseconds. 
     According to still further features in the described preferred embodiments, each of the positive peaks has a duration of 150-300 microseconds. 
     According to still further features in the described preferred embodiments, the signal consists of a plurality of pulses, each of the pulses including a positive voltage differential phase and a negative voltage differential phase, wherein the plurality of pulses has a frequency in the range of 0.5-150 pulses per second (PPS). 
     According to still further features in the described preferred embodiments, the plurality of pulses has a frequency in the range of 25-150 PPS. 
     According to still further features in the described preferred embodiments, the localized change is an increase in the flow of blood through the blood vessel. 
     According to still further features in the described preferred embodiments, the localized change is a decrease in the flow of blood through the blood vessel. 
     According to still further features in the described preferred embodiments, the voltage differential is a plurality of voltage differentials. 
     According to still further features in the described preferred embodiments, the voltage differential is controlled by the control means so as to induce a repeated, contracting, directional movement of muscular tissue associated with the blood vessel, thereby achieving the localized increase in the flow of blood through the blood vessel. 
     According to still further features in the described preferred embodiments, the control means control the wave forms so as to obtain a resultant signal of defined direction, frequency and strength, whereby a repeated, contracting movement of muscular tissue is induced. 
     According to still further features in the described preferred embodiments, the device further includes: (e) an instrument for measuring blood flow, operatively connected to the control means. 
     According to still further features in the described preferred embodiments, the control means are further designed to initiate the sequence of electrical impulses based on an input from the instrument. 
     According to still further features in the described preferred embodiments, the instrument includes a pressure sensor for producing blood pressure data. 
     According to still further features in the described preferred embodiments, the control means are further designed to synchronize the sequence of electrical impulses with pulses of blood corresponding to heartbeats. 
     According to still further features in the described preferred embodiments, the signal generator includes at least two signal generators. 
     According to still further features in the described preferred embodiments, the device further includes: (e) amplifiers, operatively connected in parallel to the signal generator. 
     The present invention successfully addresses the shortcomings of the existing technologies by providing a painless, external, non-invasive method of enhancing or reducing a localized flow of blood. The present invention is simple, easy to adjust, and is readily adaptable to the needs of a specific patient. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The invention is herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of the preferred embodiments of the present invention only, and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the invention may be embodied in practice. In the drawings: 
         FIG. 1  provides a schematic illustration of a section of a forearm to which are affixed a first electrode and a second electrode, according to the prior art; 
         FIG. 2  provides a schematic illustration of the inner tissues of the forearm section of  FIG. 1 ; 
         FIG. 3  is a cross sectional diagram depicting the peristaltic pumping principle; 
         FIG. 4  provides a schematic illustration of a method for enhancing blood flow using a large plurality of electrodes, according to one aspect of the present invention; 
         FIG. 5  provides a schematic illustration of a method for enhancing blood flow using two electrode pairs operatively connected to a system having at least two signal generators; 
         FIG. 6  provides a schematic illustration of a method for enhancing blood flow using a single electrode pair; 
         FIG. 7   a  provides a schematic illustration of a system for enhancing blood flow according to the method described in the description accompanying  FIG. 5 ; 
         FIG. 7   b  provides a schematic illustration of a system for enhancing blood flow according to the method described in the description accompanying  FIG. 6 ; 
         FIG. 8   a  is a graph showing an exemplary voltage vs. time curve for a treatment method according to the present invention; 
         FIG. 8   b  is a graph showing another exemplary voltage vs. time curve for a treatment method according to the present invention; 
         FIG. 9   a  is a plot showing blood flow through a blood vessel, as a function of time, measured using a Doppler instrument, during a normal period prior to initiating the treatment method of the present invention; 
         FIG. 9   b  is a plot showing blood flow through a blood vessel as a function of time, using the treatment method of the present invention; 
         FIG. 10   a  is a plot showing blood flow through a blood vessel as a function of time, before implementing the treatment method of the present invention, the blood flow being measured using a Doppler instrument having ultrasound capability for mapping the blood vessel; 
         FIG. 10   b  is a plot showing blood flow through a blood vessel as a function of time, using the instrument of  FIG. 10   a , and applying the treatment method of the present invention; 
         FIG. 11   a  is a magnified view of the blood vessel mapping shown in  FIG. 10   a , and 
         FIG. 11   b  is a magnified view of the blood vessel mapping shown in  FIG. 10   b.    
     
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     According to the teachings of the present invention there is provided a treatment method for promoting a localized increase in a flow of blood through a blood vessel in a particular area of the body. 
     The principles and operation of this process according to the present invention may be better understood with reference to the drawings and the accompanying description. 
     Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of the components set forth in the following description or illustrated in the drawing. The invention is capable of other embodiments or of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting. 
     As used herein in the specification and in the claims section that follows, the term “polarity” refers to any an absolute magnitude of voltage, including zero voltage. 
     As used herein in the specification and in the claims section that follows, the term “modulated” and “modulation” refer to a process of changing one or more property of electromagnetic energy by methods known in the art and realizable using various commercially available devices. 
     As used herein in the specification and in the claims section that follows, the term “voltage differential” refers to an absolute difference between two distinct voltage values. 
     As used herein in the specification and in the claims section that follows, the term “peristaltic” refers to a property common to peristalsis, wherein one or more vessels carrying fluids is compressed in a series of concerted contractions or constrictions in order to move the fluids in a desired direction. 
     As used herein in the specification and in the claims section that follows, the term “instrumentally measured blood flow” and the like include instrumentally measured flow rates measured using any direct or indirect method. The term is also meant to include any direct or indirect instrumental methods of sensing the heartbeat or the pulsing of blood. Specifically, the term is meant to include methods that utilize pressure sensors to determine relative or absolute blood flow rates, or to sense the pulsing of blood. 
     In  FIG. 1  is provided a schematic illustration of a section  20  of a forearm to which are affixed a first electrode  22  at one end of section  20  and a second electrode  24  at the opposite end of section  20 . Electrodes  22 ,  24  are operatively connected to a power source (not shown). It is known in the art that the application of a suitable voltage differential and current to electrodes  22 ,  24 , results in a contraction of muscular tissue (see  FIG. 2 ). The contraction occurs with a certain time delay, and at a point  26  approximately midway between electrodes  22 ,  24 . 
     In  FIG. 2  is provided a schematic illustration of the inner tissues of the forearm section of  FIG. 1 , which include bone  151 , muscle fibers forming muscle  153 , and body fluid vessel  152 . Vessel  152 , (a general term for blood-transporting conduits, which includes, but is not limited to, arteries and veins) located between muscle  153  and skin  150 , carries blood substantially along the length of muscle  153 . 
     Subsequent to applying a current to electrode groups  110  and  120 , a muscular contractions occurs, causing a bulge or knot  154  in the fibers of muscle  153 , thereby impinging upon vessel  152  at constriction point  155 . 
     It has been discovered by the inventor that this phenomenon can be harnessed to enhance the flow of blood through vessel  152 . Without wishing to be limited by theory, the inventor attributes the enhanced flow of blood to a peristaltic effect in which the electric current causes such muscular contractions and blood vessel constrictions to occur in series along the length of the muscular tissue. The series of blood vessel constrictions occurs in a very short time frame, such that the flow of blood within the blood vessel is enhanced in a direction predetermined by the form of the electric impulse delivered to the electrodes. 
     The peristaltic pumping action is better understood by referring to  FIG. 3 . A typical peristaltic pump utilizes tubing  130  that contains and conveys the pumped fluid. Wall  135  of tubing  130  is typically made of resilient and pliable synthetic material and the tubing  130  is conformed to a U-shaped pattern as shown in the diagram. Against the tubing are disposed-three equidistantly and radially arranged rollers  137 ,  139  and  141 , which are mounted on a frame  140  that is typically driven by any type of electrical motor, in direction  136 . The axis of the frame  140  is disposed such that two of the three rollers held thereon cause the tubing  130  to be compressed and constricted: roller  139  creates a constriction point  144  and roller  141  creates a constriction point  143 . Subsequent to rotation of the frame  140  in counterclockwise fashion, a pumping action is effected whereby a portion  133  of the fluid is drawn inward in direction  131 , a portion  142  of the fluid is entrained between constriction points  143  and  144  created by rollers  141  and  139  respectively, such that portion  142  is caused to move along direction  136 , and a portion of fluid  134  is caused to be driven outward in direction  132 . Thus, the peristaltic motion causes blood to flow from inlet  124  to outlet  126 . 
     Peristaltic transportation by the wavelike constriction of involuntary muscle tissue is a mechanism used by the body to move food along the length of the alimentary canal. The involuntary muscular walls of arteries can expand or contract to enhance or constrict the flow of blood. 
     According to the present invention, this principle can be applied by providing a series of external electric impulses, such that the muscular contractions (and hence, the constrictions of an adjacent blood vessel) occur along the length of the muscular tissue in a timely fashion that is conducive to peristaltic flow. 
     The peristaltic pumping effect can be achieved in various ways.  FIG. 4 , by way of example, provides a schematic illustration of the forearm section  20  shown in  FIG. 1 , to which are affixed a series of electrodes  51 - 60  disposed between site A and site B of the forearm section  20 . It must be emphasized that in  FIG. 4  and in the accompanying description, the number of electrodes, the positioning of the electrodes, and the sequence in which the voltage differential is applied are provided by way of example, in order to illustrate the invention. It will be appreciated by one skilled in the art that many other configurations and sequences are possible. 
     Electrodes  51 - 60  are operatively connected to one or more signal generators (not shown), however, for the purpose of this example, a single signal generator is used. The signal generator first provides a suitable voltage differential and current to electrodes  51  and  52 , resulting in a contraction of muscular tissue, with a certain time delay, and at a point  62  midway between electrodes  51  and  52 . This contraction causes a constriction in a blood vessel adjacent to the muscular tissue, as described above. Subsequently, the signal generator provides a voltage differential to electrodes  51  and  52 , resulting in further contraction of muscular tissue, this time at a point  64  approximately midway between electrodes  51  and  53 . Subsequently, the signal generator provides a voltage differential to electrodes  51  and  54 , resulting in further contraction of muscular tissue, this time at a point  66  midway between electrodes  51  and  54 . Subsequently, the signal generator provides a voltage differential to electrodes  51  and  55 , resulting in further contraction of muscular tissue, this time at a point  68  midway between electrodes  51  and  55 . It may be advantageous to activate an electrode other than electrode  51 . Thus, in the next stage of the sequence, the signal generator can provide a voltage differential to electrodes  52  and  55 , resulting in further contraction of muscular tissue, this time at a point  70 , approximately midway between electrodes  52  and  55 . The sequence described above can be continued until the final contraction in the sequence (at point  72 ) is achieved by supplying a voltage differential to electrodes  59  and  60 . 
     It has thus been demonstrated how a series of muscular contractions can be propagated along a length of muscular tissue, in this case between site A and site B of forearm  20 . This series of contractions enhances the flow of blood by constricting an adjacent blood vessel so as to substantially effect peristaltic pumping. 
     It has been further discovered by the inventor that peristaltic pumping from site A to site B can be effected in such a blood vessel even without the positioning of electrodes across the length between site A and site B, as previously illustrated in  FIG. 4 .  FIG. 5  provides a schematic illustration of the forearm section  20  shown in  FIG. 1  and  FIG. 4 , to which are affixed a first electrode pair,  80 A and  80 B, and a second electrode pair,  82 A and  8211 . By way of example, electrodes  80 A and  82 A are situated near the end of site A, and electrodes  80 B and  82 B are situated near the end of site B of forearm section  20 . As shown in  FIG. 7   a , each electrode pair is operatively connected to a different signal generator. Initially, a voltage differential is applied to first electrode pair  80 A and  80 B, by a first signal generator  85 . Very shortly thereafter, a voltage differential is applied to second electrode pair  82 A and  82 B, by a second signal generator  87 , wherein the sign on the voltage differential is reversed relative to the initial impulse provided to first electrode pair  80 A and  80 B. 
     As a result, the initial muscular contraction does not occur halfway between the above-mentioned electrode pairs, as might be anticipated, but at point  86 , close to the end of site A. Without wishing to be limited by theory, it is believed that this phenomenon is related to the fact that a muscle is fundamentally different from an ideal resistor in that a muscle is an extremely complex resistor having an inherent lag time until contraction occurs. In any event, after a short time interval, another voltage differential is applied to first electrode pair  80 A and  80 B by first signal generator  85 . Immediately thereafter, a voltage differential is applied to second electrode pair  82 A and  82 B, by second signal generator  87 , as described above. Consequently, the muscle continues to contract from point  86  to point  88 . This sequence is repeated several times, and the point of contraction shifts from point  88  to point  90 , from point  90  to point  92 , and ultimately, the point of contraction reaches point  94 , located near site B. As explained above, the point of constriction of the adjacent blood vessel (see  FIG. 3 ) substantially parallels the point of contraction of the muscular tissue. Thus, the directional constriction of the blood vessel increases the flow within the blood vessel due to the peristaltic effect. If the directional constriction of the blood vessel is opposite to the natural direction of flow in the blood vessel, the peristaltic effect reduces the flow of blood coming from the heart. 
     Upon reaching point  94 , the cycle is reinitiated, with the point of contraction again occurring near point  86 . 
     Preferably, the voltage differential applied to second electrode pair  82 A and  82 B by second signal generator  87 , wherein the sign on the voltage differential is reversed relative to the initial impulse provided to first electrode pair  80 A and SOB, is timed such that the initiation of the voltage differential takes place before the voltage differential applied to first electrode pair  80 A and  80 B by first signal generator  85  has been terminated. Exemplary voltage vs. time curves are provided in  FIGS. 8   a  and  8   b , described in Example 1 below. 
       FIG. 6  illustrates a more simple configuration of the present invention, one that requires only a single electrode pair. By way of example,  FIG. 6  provides a schematic illustration of the forearm section  20  shown in  FIGS. 1 ,  4  and  5 , to which is affixed a single electrode pair,  180 A and  180 B, substantially in the same location as single electrode pair  80 A and  80 B shown in  FIG. 5 . Electrode pair  180 A and  180 B is connected to 4 amplifiers (a 1 -a 4 ) in a differential floating scheme, as shown in  FIG. 7   b  and as described in further detail below. 
     This configuration enables each electrode in electrode pair  180 A and  180 B to change polarity from a positive charge to a negative charge, and vice versa, according to the program that the controller dictates to signal generators  85 ,  87 . In essence, electrode  180 A performs the function of electrodes  80 A and  82 A ( FIG. 5 ), and similarly, electrode  180 B performs the function of electrodes  80 B and  82 B. 
       FIG. 7   a  is a schematic electric diagram of the system referred to in the description of  FIG. 5 .  FIG. 7   b  is a schematic electric diagram of the system referred to in the description of  FIG. 6 . In  FIG. 7   a , system  300  includes electrodes  80 A and  80 B connected to amplifiers a 1  and a 2 , respectively. Amplifiers a 1  and a 2  are connected to signal generator  85 , which is in turn connected to a power supply (not shown). Similarly, electrodes  82 A and  82 B are connected to amplifiers a 3  and a 4 , respectively. Amplifiers a 3  and a 4  are connected to signal generator  87 , which is in turn connected to a power supply (not shown). When electrodes  80   a  and  80   b  (or electrodes  82 A and  82 B) are electrically contacted to an area of skin on the patient, a current is passed through the area in order to complete the electric circuit. 
     In  FIG. 7   b , system  400  includes electrode  180 A connected to amplifiers a 2  and a 3 , and electrode  180 B connected to amplifiers a 1  and a 4 . Amplifiers a 1  and a 2  are connected to signal generator  85 , as in  FIG. 7   a  described above. Similarly, amplifiers a 3  and a 4  are connected to signal generator  87 , as in  FIG. 7   a . Amplifiers a 1 -a 4  are disposed in a differential floating configuration. 
     When electrodes  180   a  and  180   b  are electrically contacted to an area of skin on the patient, a current is passed through the area in order to complete the electric circuit. 
     The frequency, the number, the intensity and the duration of muscle contractions are controlled by the modulation characteristics of the current passed to the electrodes. The treatment method of the invention provides for repeating the passing of the modulated voltage to the treated area sufficient number of times so as to affect a localized increase in the flow of blood. This is important in a wide variety of medical applications, including but not limited to rehabilitating muscular response affected by a trauma, inactivity, decreasing the amount of water retained, as in case of the lower limbs, improving blood and lymph circulation, thereby alleviating pain, therapy related to controlling the function of erectile tissue, and speeding up healing, particularly in the case of diabetic patients. The restriction of blood flow by inducing the repeated, contracting movement of muscular tissue against the natural flow of blood is also germane to a wide variety of medical applications, including various surgical procedures. 
     Various frequencies and wave forms have been found to be effective in the method of the present invention. Appropriate wave forms include square waves, waves of transcendental functions, spikes, linear functions, and stepped patterns. Frequencies vary greatly, depending on the general health of the client, the type and duration of the treatment, etc. 
     It must also be emphasized that the experienced operator can adjust the wave forms, frequencies, and intensity according to the needs of the individual patient. 
     In  FIG. 7   b , the wave form, frequency, etc. produced by signal generator  85  and by signal generator  87  are controlled by CPU  89 . In a preferred embodiment of the present invention, the parameters dictated by CPU  89  are pre-determined. It must be emphasized that various frequencies and wave forms have been found to be effective in conjunction with the method of the present invention. Appropriate wave forms include square waves, waves of transcendental functions, spikes, linear functions, and stepped patterns. Frequencies vary greatly, depending on the general health of the client, the type and duration of the treatment, etc. Hence, it is preferable that the device be configured such that an operator can easily adjust such parameters in CPU  89 . 
     Another preferred embodiment, in which the signal generators are controlled by CPU  89  based on input from a sensor  91 , is described hereinbelow. 
       FIG. 9   a  is a plot showing blood flow through a blood vessel as a function of time, before implementing the treatment method of the present invention. The magnitude of the blood flow is correlated to the linear velocity, which is measured using a Doppler instrument. The major peaks  220  correspond to the linear velocity of the blood through the blood vessel during each pulse (heartbeat). The minor peaks  230  correspond to the linear velocity of the blood through the blood vessel between pulses. The average magnitude of major peaks  220  is 21.1 cm/s; The average magnitude of minor peaks  230  is 6.0 cm/s. 
     After completing the plot provided in  FIG. 9   a , the treatment method of the present invention was implemented on the subject.  FIG. 9   b  shows the linear velocity of the blood flowing through the blood vessel as a function of time. The major peaks  320  have an average magnitude of 30.8 cm/s. The minor peaks  330  have an average magnitude of 6.7 cm/s. Thus, the average magnitude of the major peaks is increased by 40-50%, which indicates an appreciable increase in the local blood flow through the blood vessel. 
       FIG. 10   a  is another plot, similar to  FIG. 9   a , showing the linear velocity of the blood flowing through a blood vessel as a function of time, before implementing the blood flow enhancement (BFE) method of the present invention. The linear velocity is measured using a Doppler instrument having ultrasound capability for mapping the blood vessel. 
       FIG. 10   b  is a plot showing the linear velocity of the blood flowing through the blood vessel as a function of time, using the instrument of  FIG. 10   a , after applying the treatment method of the present invention. 
       FIG. 11   a  is a magnified view of the blood vessel mapping shown in  FIG. 10   a . This view is temporal, as the diameter of the blood vessel is dependent on the volumetric flow rate of the blood, which varies with time and is substantially cyclic with respect to the heartbeat.  FIG. 11   b  is a magnified view of the blood vessel mapping shown in  FIG. 10   b , in which the inventive BFE method of the present invention is applied. The width of the blood vessel, based on the ultrasound data, was found to have increased relative to the width of the blood vessel in  FIG. 11   a . The volumetric flow rate through the blood vessel is proportional to the linear velocity multiplied by the cross-sectional area of the blood vessel. The percent increase in linear velocity demonstrated in  FIGS. 9   a  and  9   b  is multiplied by the square of the width ratio to calculate the percent increase in volumetric flow rate. Hence, the increase in blood flow through the blood vessel is actually even higher than the appreciable increase in blood velocity using the BFE device and method of the present invention. 
     According to the teachings of the present invention there is provided a treatment method for promoting a localized increase or decrease in a flow of blood through a blood vessel in an area of a body, including the steps of: (a) providing a system including: (i) at least a first electrode operatively contacting a first portion of body tissue; (ii) at least a second electrode operatively contacting a second portion of body tissue, and (iii) a signal generator providing a plurality of electrical impulses having at least one voltage differential to the first electrode and the second electrode, and (b) providing the localized increase or decrease in the flow of blood through the blood vessel by inducement of a repeated, contracting, directional movement of muscular tissue associated with the blood vessel, wherein the inducement is achieved by subjecting the muscular tissue to the voltage differential via the electrodes. 
     According to further features in the described preferred embodiments, the method further includes optimizing the localized increase or decrease in the flow of blood. The optimizing is preferably based upon sensory controlled adjustment and/or instrumentally measured blood flow. 
     Although it will be appreciated that one skilled in the art could utilize various and sundry means for instrumentally measuring the blood now or the timing of the heartbeat, as described above, I have found that a pressure sensor is particularly suitable for this function. More specifically, miniature, off-the-shelf pressure sensors such as Motorola Chip Pak High Volume Sensor for Low Pressure Applications (Serial No. MPXC2011DT1) are readily connected to the CPU of the BFE device of the present invention, such that the CPU controls the electric signals produced based on the data obtained from the sensor. 
     This is more readily understood in conjunction with  FIG. 7   b , described hereinabove. Sensor  91 , which is a pressure sensor, by way of example, is operatively connected to CPU  89  in system  400 . Sensor  91  is disposed externally to the skin of the subject, in operative proximity to the rest of system  400 . Preferably, sensor  91  is disposed so as to obtain a continuous or semi-continuous reading of the blood pressure in the vicinity of electrode  180   a , which is arbitrarily defined to be the electrode that is closer to the heart. 
     The pressure in blood vessels is characteristically pulsed and substantially cyclic, corresponding to the beating of the heart and the circulation of the blood. Consequently, the maximum flow rate of blood through a blood vessel or a group of blood vessels can be sensed by sensor  91 . It has been found that the efficacy of the blood flow enhancement of the present invention is greatly improved when the induced series of muscular contractions is synchronized with the maximum flow rate of blood delivered from the heart. Thus, CPU  89  is preferably configured so as to initiate a new series of muscular contractions (via signal generators  85 ,  87 , amplifiers a 1 -a 4 , and electrodes  180   a ,  180   b ) upon receiving a maximum reading, close to maximum reading, or a reading above a pre-determined value. 
     EXAMPLES 
     Reference is now made to the following examples, which together with the above descriptions, illustrate the invention in a non limiting fashion. 
     Example 1 
       FIG. 8  shows an exemplary voltage vs. time graph for a treatment method according to the present invention, using the system described in  FIG. 7   b  and in  FIG. 6 . The impulses are square waves having an intensity of 30 Volts. The duration of each square wave is approximately 100 microseconds. It should be pointed out that the time axis has not been drawn to scale, in order to fit  3  full cycles in the graph. 
     The initial impulse provided to electrode pair  180 A and  180 B by first signal generator  85  voltage has a positive voltage differential (+30 Volts). The second impulse applied to electrode pair  180 A and  180 B by second signal generator  87 , has a reversed charge, i.e., a negative charge of −30 Volts. The second impulse overlaps the first impulse by about 50, such that the second impulse is terminated about 50 microseconds after the first impulse has been terminated. 
     The time interval between positive impulses (or between negative impulses) is approximately 1 millisecond. Although only 6 impulses are shown in  FIG. 8 , it will be appreciated that a practical treatment requires a large plurality of such impulses. 
       FIG. 8   b  is an oscilloscope tracing showing another exemplary voltage vs. time curve for a treatment method according to the present invention. Each individual pulse (or spike) has a voltage of .about.35V and a duration of 250 microseconds. The sequence is characterized by 2 positive spikes followed by 2 negative spikes. The load is approximately 500 ohms. 
     Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.