MXPA00006948A - Augmentation of electrical conduction and contractibility by biphasic cardiac pacing administered via the cardiac blood pool - Google Patents

Abstract

Augmentation of electrical conduction and contractibility by biphasic cardiac pacing. A first stimulation phase is administered to the cardiac blood pool. This first stimulation phase has a predefined polarity, amplitude and duration. A second stimulation phase is then administered to the cardiac blood pool. This second phase also has a predefined polarity, amplitude and duration. The two phases are applied sequentially. Contrary to current thought, anodal stimulation is first applied and followed by cathodal stimulation. In this fashion, pulse conduction through the cardiac muscle is improved together with the increase in contractibility.

Description

INCREASED ELECTRICAL DRIVING AND CONTRACTIBILITY THROUGH THE REGULATION OF THE CARDIAC RHYTHM, TWO-PHASE, ADMINISTERED VIA THE BLOOD CARDIAC TORRENT.

FIELD OF THE INVENTION This invention relates generally to a method for the stimulation of muscle tissue. In particular, this invention relates to a method for the stimulation and regulation of cardiac rhythm with biphasic waveforms, wherein the stimulation is administered via the cardiac bloodstream.

BACKGROUND OF THE INVENTION The function of the cardio-vascular system is vital to survive. Through the circulation of blood, body tissues obtain the necessary nutrients and oxygen, and eliminate residual substances. In the absence of circulation, the cells begin to undergo irreversible changes that lead to their death. The muscular contractions of the heart are the driving force behind the circulation. In a cardiac muscle, the muscle fibers are interconnected in networks REF .: 121826 branched that are scattered in all directions by the heart. When any portion of this network is stimulated, a wave of depolarization passes to all its parts, and the entire structure contracts as a unit. Before a muscle fiber is stimulated to contract, its membrane must be polarized. A muscle fiber generally remains polarized until it is stimulated by some change in its environment. A membrane can be stimulated electrically, chemically, mechanically, or by changing the temperature. The minimum stimulation force necessary to produce a contraction is known as the threshold stimulus. The maximum stimulation amplitude that can be administered without contraction occurs is the maximum subthreshold amplitude. When the membrane is electrically stimulated, the pulse amplitude required to produce a response depends on a number of factors. First, there is the duration of the current flow. Since the total charge transferred is equal to the times of the current amplitude of the pulse duration, the increased duration of the stimulus is associated with a decrease in the amplitude of the threshold current. Second, the percentage of applied current that actually travels the membrane, varies inversely with the size of the electrode. Third, the percentage of the applied current that actually travels the membrane varies directly with the proximity of the electrode to the tissue. Fourth, the pulse amplitude required to produce a response depends on the stimulation time within the excitability cycle. Much of the heart are groups and branches of muscle tissue, cardiac, specialized. This tissue comprises the cardiac conduction system and serves to initiate and distribute depolarization waves throughout the myocardium. Any interference or blockage in the conduction of the cardiac impulse can cause an arrhythmia or a marked change in the speed or rhythm of the heart. Sometimes a patient suffering from a driving disorder can be helped by means of a cardiogenic device or artificial pacemaker. Such a device contains an electric stimulator energized by a small battery. When the artificial pacemaker is installed, electrodes are usually enhiladed by most of the veins in the right ventricle, or in the right atrium and right ventricle, and the stimulator is implanted under the skin in the shoulder or abdomen. . The connections or conductors are placed in intimate contact with the cardiac tissue. Then, the pacemaker transmits electrical and rhythmic impulses to the heart, and the myocardium responds rhythmically contracting. Medical devices that can be implanted to regulate heart rhythm are well known in the art, and these have been used in humans since about the middle of the 1960s. Any anodic or cathodic current can be used to stimulate the myocardium . However, it is believed that the anode current is not useful clinically. The cathodic current comprises electrical pulses of negative polarity. This type of current depolarizes the membrane of the cell by discharging the capacitor of the membrane, and directly reduces the potential of the membrane towards the threshold level. The cathodic current, directly reducing the potential of the latent membrane to the threshold value, has from half to a third the threshold current lower in the late diastole or last than the anodic current. The anodic current comprises electrical pulses of positive polarity. The effect of the anodic current is to hyperpolish the latent membrane. In the sudden termination of the anodic pulse, the potential of the membrane returns to the latent level, passes over the threshold, and a propagated response occurs. The use of anodic current to stimulate the myocardium is generally discouraged due to the increased stimulation of the threshold, which leads to the use of a higher current, resulting in a battery emptying of an implanted device and a deteriorated longevity. In addition, the use of the anodic current for cardiac stimulation is disapproved due to the suspicion that the contribution of the anode to depolarization can, particularly at higher voltages, contribute to arrhythmioses. Virtually all the operation of a brand steps lies in the use of negative stimulation pulses, or in the case of bipolar systems, the cathode is closer to the myocardium than the anode is. Where the use of anodic current is described, it is generally handled as a load of magnitude of minutes used to dissipate the residual charge at the electrode. This does not affect or condition the myocardium on its own. Such use is described in U.S. Patent No. 4,543,956 by Hersco ici. The use of a three-phase waveform has been described in U.S. Patent No. 4,903,700 and No. 4,821,724 by Whigham et al., And in U.S. Patent No. 4,343,312 by Cals et al. Here, the first and third phases have nothing to do with the myocardium per se, but are only expected to affect the surface of the electrode itself. Thus, the load applied in these phases is of a very low amplitude. Lately, biphasic stimulation has been described in U.S. Patent No. 4,402,322 by Duggan. The purpose of this description is to produce a doubling of the voltage without the need for a large capacitor in the output circuit. The phases of the biphasic stimulation described are of equal magnitude and duration. What is needed is to improve the means to stimulate the muscle tissue, where the contraction produced is intensified and the damage to the tissue adjacent to the electrode is reduced. The function of the increased myocardium is obtained by regulating the two-phase rhythm of the present invention. The combination of the cathodic pulses with the anodic pulses of any nature of conditioning or stimulation, preserves the improved conduction and the contractibility of the regulation of the anodic rhythm while eliminating the disadvantage of the increased stimulation threshold. The result is an increased propagation velocity depolarization wave. This increased rate of propagation results in a superior cardiac contraction that leads to an improvement in blood flow. Improved stimulation at a lower voltage level also results in reduced energy consumption and increases the life of the batteries of the marking steps. Lately, the improved stimulation obtained by the practice of the present invention allows cardiac stimulation without the need to place electrical conductors in intimate contact with the cardiac tissue. The standard stimulus delivered to the bloodstream is ineffective in the capture of the myocardium, this because it does not meet the threshold of stimulation. While the voltage of the pulse generator can be increased, when this capture is often so high that it also stimulates the skeletal muscles which causes painful tightening of the chest wall only when the stimulation of the heart is desired. As will be most discussed, by means of the practice of the aforementioned invention, one can increase the function of the myocardium by stimulating the cardiac bloodstream. As for the cardiac muscle, striated muscle can also be stimulated electrically, chemically, mechanically or by changing the temperature. Where the muscle fiber is stimulated by a motor neuron, the neuron transmits an impulse that activates all the muscle fibers within its control, that is, those muscle fibers in its motor unit. Depolarization in a region of the membrane also stimulates the adjacent regions to depolarize, and a depolarization wave travels through the membrane in all directions away from the stimulation site. Thus, when a motor neuron transmits an impulse, all the muscle fibers in its motor unit are stimulated to contract simultaneously. The minimum force to produce a contraction is known as a threshold stimulus. Once this level of stimulation is reached, the general belief is that the increase in level does not increase the contraction. Additionally, since the muscle fibers within each muscle are organized into motor units, and each motor unit is controlled by a single motor neuron, all the muscle fibers in a motor unit are stimulated at the same time. However, the muscle as a whole is controlled by many different motor units that respond to different stimulation thresholds. Thus, when a given stimulus is applied to a muscle, some motor units can respond while others can not. The combination of anodic and cathodic pulses of the present invention also provides improved contraction of striated muscle, where electrical muscle stimulation is indicated due to muscle or nerve damage. When the nerve fibers have been damaged due to a trauma or condition, the muscle fibers in the regions supplied by the damaged nerve fiber tend to suffer atrophy and wear. A muscle that can not be exercised can decrease to half its usual size in a few months. Where there is no stimulation, not only the fibrous muscles will decrease in size, but they will also fragment and degenerate, and will be replaced by a connective tissue. Through electrical stimulation one can maintain muscle tone, so that once the nerve fiber heals or regenerates, muscle tissue remains viable. The increased contraction of the muscle is obtained by the biphasic stimulation of the present invention. The combination of anodic and cathodic pulses of any nature of conditioning or stimulation, results in the contraction of a greater number of motor units at a lower voltage level, which leads to a superior muscular response.

BRIEF DESCRIPTION OF THE INVENTION It is therefore an object of the present invention to provide improved stimulation of cardiac tissue. It is another objective of the present invention to increase the cardiac output by means of an upper cardiac contraction, which leads to a greater volume of pulsations or beats. It is another object of the present invention to increase the velocity of impulse propagation. It is another object of the present invention to increase or extend the useful life of the battery of the marking steps. It is another object of the present invention to obtain effective cardiac stimulation at a lower voltage level. It is another object of the present invention to eliminate the need to place electrical conductors in intimate contact with the tissue to obtain tissue stimulation. It is another object of the present invention to provide improved stimulation of muscle tissue. It is another object of the present invention to provide the contraction of a greater number of muscle motor units at a lower voltage level. An apparatus and method for muscle stimulation according to the present invention includes the administration of biphasic stimulation to muscle tissue, wherein both anodic and cathodic pulses are administered. In accordance with one aspect of the present invention, this stimulation is administered to the myocardium in order to increase the function of the myocardium. According to a further aspect of the present invention, this stimulation is administered to the cardiac bloodstream and subsequently conducted to the cardiac tissue. This allows cardiac stimulation without the need to place electrical conductors in intimate contact with the cardiac tissue. According to yet another aspect of the present invention, the stimulation is administered to the striated muscle tissue to evoke muscular response. The electronic parts of the mark steps that are needed to carry out the method of the present invention are well known to those skilled in the art. The electronic parts of the step mark can be programmed to supply a variety of pulses, including those described here. The method and apparatus of the present invention comprise first and second stimulation phases, each stimulation phase having a polarity, shape and duration. In a preferred embodiment the first and second phases have different polarities. In an alternative mode, the two phases are of different amplitude. In a second alternative mode, the two phases are of different duration. In a third alternative mode, the first phase is a sectioned waveform. In a fourth alternative mode, the amplitude of the first phase is ramp. In a fifth alternative mode, the first phase is administered for more than 200 milliseconds after a pumping / latching cycle has been completed. In a preferred alternative embodiment, the first stimulation phase is an anodic pulse at the maximum threshold amplitude for a long duration, and the second stimulation phase is a cathode pulse of short duration and high amplitude. It will be noted that the aforementioned alternative modalities can be combined in different ways. It will also be noted that these alternative modalities are presented only by way of example, and are not intended to be limiting.

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a schematic representation of the connection for anodic biphasic stimulation. Figure 2 is a schematic representation of the connection for the cathodic biphasic stimulation. Figure 3 is a schematic representation of the connection for low-level long-term anodic stimulation, followed by conventional cathode stimulation. Figure 4 is a schematic representation of the connection for anodic stimulation of low level of ramp and long duration, followed by a conventional cathodic stimulation. Figure 5 is a schematic representation of the connection for low level, short duration anodic stimulation, administered in series followed by a conventional cathodic stimulation. Figure 6 is a graph of the conduction velocity that the fiber travels, against the duration of the regulation of the rhythm resulting from the conduction of the anodic biphasic pulse. Figure 7 is a graph of the conduction velocity parallel to the fiber, against the duration of the regulation of the rhythm resulting from the conduction of the biphasic anodic pulse.

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to the biphasic electrical stimulation of muscle tissue. Figure 1 describes a biphasic electrical stimulation wherein a first stimulation phase comprising an anodic stimulus 102 is administered having an amplitude 104 and a duration 106. This first stimulation phase is immediately followed by a second stimulation phase comprising Cathodic stimulation 108 of equal intensity and duration. Figure 2 describes the biphasic electrical stimulation, where a first stimulation phase comprising the cathodic stimulation 202 having amplitude 204 and duration 206 is administered. This first stimulation phase is immediately followed by a second stimulation phase comprising the stimulation. Anodic stimulation 208 of equal intensity and duration. Figure 3 describes a preferred embodiment of the present invention, wherein a first stimulation phase comprising a low level, and long-acting anodic stimulation 302 having an amplitude 304 and duration 306 is administered. This first stimulation phase is immediately followed by a second stimulation phase comprising the cathode stimulation 308 of conventional intensity and duration. In an alternative embodiment of the invention, the anodic stimulation 302 is at its maximum subthreshold amplitude. In yet another alternative embodiment of the invention, the anodic stimulation 302 is less than three volts. In yet another alternative embodiment of the invention, the anodic stimulation 302 is of a duration of approximately two to eight milliseconds. In yet another alternative embodiment of the invention, cathodic stimulation 308 is of short duration. In yet another embodiment of the invention, cathodic stimulation 308 is from about 0.3 to 0.8 milliseconds. In yet another alternative embodiment of the invention, the cathode stimulation 308 is of a high amplitude. In another embodiment of the invention, cathode stimulation 308 is within the range of three and twenty volts. In yet another alternative embodiment of the present invention, cathodic stimulation 308 is of a duration less than 0.3 milliseconds at a voltage greater than twenty volts. In another alternative embodiment, anodic stimulation 302 is administered for more than 200 milliseconds after the heartbeat. In the way described by these modalities, as well as in those alterations and modifications that can become obvious from the reading of this specification, in the first phase of stimulation a maximum membrane potential without activation is obtained. Figure 4 describes a preferred, alternative embodiment of the present invention, wherein a first stimulation phase comprising anodic stimulation 402 is administered for a period 404 with the increase in intensity level 406. The ramp of the increase in the intensity level 406 can be linear or non-linear, and the slope can vary. This anodic stimulation is immediately followed by a second stimulation phase comprising 408 cathodic stimulation, of conventional duration and intensity. In an alternative embodiment of the present invention, anodic stimulation 402 increases to a maximum subthreshold amplitude. In yet another alternative embodiment of the invention, anodic stimulation 402 increases to a maximum amplitude that is less than three volts. In yet another alternative embodiment of the invention, the anodic stimulation 402 is of a duration of about two to eight milliseconds. In yet another alternative embodiment of the invention, cathodic stimulation 408 is of a short duration. In another alternative embodiment of the invention, the cathodic stimulation 408 is from about 0.3 to 0.8 milliseconds. In yet another embodiment of the present invention, cathodic stimulation 408 is of high amplitude. In yet another alternative embodiment of the invention, cathodic stimulation 408 is approximately within the range of three to twenty volts. In yet another embodiment of the present invention, cathodic stimulation 408 is of a duration less than 0.3 milliseconds and at a voltage greater than twenty volts. In another alternative modality, anodic stimulation 402 is administered for 200 milliseconds after the heartbeat. In the way described by these modalities, as well as in those alterations and modifications that can become obvious from the reading of this specification, in the first phase of stimulation a maximum membrane potential without activation is obtained.

Figure 5 describes a biphasic electrical stimulation, wherein a first stimulation phase comprising the series 502 of the anodic pulses is administered at an amplitude 504. In one embodiment, the rest period 506 is equal to the duration of the stimulation period 508. and it is administered at baseline amplitude. In an alternative embodiment, the rest period 506 is of a duration different from the stimulation period '508 and is administered at the baseline amplitude. The rest period 506 occurs after each stimulation period 508, with the exception that the second stimulation phase comprising the cathodic stimulation 510 of conventional intensity and duration, immediately follows the completion of the 502 series. alternative of the present invention, the total load transferred through the series 502, of the anodic stimulation, is at the maximum threshold level. In yet another alternative embodiment of the invention, the first stimulation pulse of the 502 series is administered for 200 milliseconds after the heart beat. In another alternative embodiment of the invention, the cathodic stimulation 510 is of a short duration. In yet another embodiment of the invention, cathodic stimulation 510 is from about 0.3 to 0.8 milliseconds. In another alternative embodiment of the invention, the cathodic stimulation 510 is of a high amplitude. In yet another alternative embodiment of the invention, cathodic stimulation 510 is approximately within the range of three to twenty volts. In yet another alternative embodiment of the invention, the 510 cathodic stimulation is of a duration of less than 0.3 milliseconds and at a voltage greater than twenty or 11 io s.

EXAMPLE 1 The characteristics of myocardial stimulation and propagation were studied in isolated hearts using pulses of different polarities and phases. The experiments were carried out on five rabbit hearts, scattered, Langerdorff type. The conduction velocity in the epicardium was measured using an array of bipolar electrodes. Measurements were made between six millimeters and nine millimeters from the stimulation site. The transmembrane potential was recorded using a floating intracellular microelectrode. The following protocols were examined: monophasic cathodic pulse, monophasic anodic pulse, connection of the biphasic cathode pulse and the connection of the biphasic anodic pulse. Table 1 describes the conduction velocity that runs in the direction of the fiber for each stimulation protocol administered, with stimulations of three, four and five volts and a pulse of two milliseconds in duration.

TABLE 1 Driving Speed that is Traveled in Fiber Direction, with 2 milliseconds of duration 3V 4V 5V fcnofásica Catódica 18.9 ± 2.5 an / seg 21.4 ± 2.6 sn / seg 23.3 ± 3.0 an / sec Manofascial Anodic 24.0 ± 2.3 an sßg 27.5 ± 2.1 cm / sec 31.3 ± 1.7 an / sec Csnexisri Cathodic Biphasic 27.1 ± 1.2 an / sec 28.2 ± 2.3 an / sec 27.5 + 1.8 an ^ sec Canesd? N Biphasic Anodic 26.8 ± 2.1 an / sec 28.5 ± 0.7 an sec 29.7 ± 1.8 cm sec Table 2 describes the conduction velocity- along the direction of the fiber, for each stimulation protocol administered, with stimulations of three, four and five volts and pulse duration of two thousand isecond.

TABLE 2 Driving Speed that is Traveled in Fiber Direction, with 2 milliseconds duration 3V 4V 5V Single-phase Cathodic 45.3 ± 0.9 ar sec 47.4 ± 1.8 an / sec 49.7 ± 1.5 a sec Single-phase Anodic 48.1 ± 1.2 anseg 51.8 ± 0.5 cm / sec 54.9 ± 0.7 an / sec Cathodic Biphasic Ccnnexicn 50.8 ± 0.9 an / sec 52.6 ± 1.1 an / sec 52.8 ± 1.7 an / sec Ccnexicn Biphasic Anodic 52.6 ± 2.5 an / sec 55.3 ± 1.5 sn / sec 54.2 ± 2.3 an / sec the differences in conduction velocities between the cathodic monophasic, monophasic anodic, cathodic biphasic connection and biphasic anodic connection were found to be significant (p <0.001). From the measurements of the transmembrane potential, the maximum ascent ((dV / dt) max) of the action potentials was found to correspond well with the changes in the conduction velocity in the longitudinal direction. For a four-volt pulse of two milliseconds in duration, the (dV / dt) max was 63.5 ± 2.4 V / sec for the cathode pulses, and 75.5 ± 5.6 V / sec for the anodi eos.

EXAMPLE 2 Using rabbit hearts, isolated, prepared, Langendorff type, the effects on the variation of rhythm regulation protocols in the elec tro ry f log ics were analyzed. The stimulation was applied to the heart to a rectangular pulse of constant voltage. The following protocols were examined: monophasic anodic pulse, monophasic cathodic pulse, biphasic anodic pulse connection and the cathodic biphasic pulse connection. The administered voltage was increased by one step from one to five volts for both the cathodic and the anodic stimulations. The duration was increased in steps of two milliseconds from two to ten milliseconds. The conduction velocities of the epicardium were measured along and transverse to the direction of the left ventricular fiber at a distance between three and six millimeters from the free left ventricle wall. Figures 6 and 7 describe the effects of stimulation pulse duration and the stimulation protocol administered at driving speeds.

Figure 6 describes the speeds measured between three and six millimeters transverse to the direction of the fiber. In this region, the cathodic monophasic stimulation 602 demonstrates the slowest conduction velocity for each pulse duration of stimulation tested. This is followed by the monophasic anodic stimulation 604 and the connection of the cathodic biphasic stimulation 606. The faster conducting speed is demonstrated by means of the connection of the biphasic anodic stimulation 608.

Figure 7 describes the speeds measured between three and six millimeters parallel to the direction of the fiber. In this region, cathodic monophasic stimulation 702 demonstrates the slowest conduction velocity for each of the stimulation pulse durations tested. The results of the speeds of the anodic monophasic stimulation 704 and the connection of the cathodic biphasic stimulation 706 are similar with the anodic monophasic stimulation that shows slightly higher speeds. The fastest driving speed is demonstrated by the connection of the anodic biphasic stimulation 708.

In one aspect of the invention, electrical stimulation is administered to the cardiac muscle. The anodic stimulation component of biphasic electrical stimulation increases cardiac contractibility by hyperpolarization of the tissue before excitation, leading to a faster impulse conduction, more intracellular calcium release, and the resulting superior cardiac contraction. The cathodic stimulation component eliminates the disadvantages of anodic stimulation, resulting in effective cardiac stimulation at a lower voltage level that could be required with anodic stimulation alone. This, in turn, extends the battery life of the marking steps and reduces the damage caused to the fabric.

In a second aspect of the invention, the biphasic electrical stimulation is administered to the cardiac bloodstream, that is, the blood that enters and surrounds the heart. This allows cardiac stimulation without the need to place electrical connections in intimate contact with cardiac tissue, thereby decreasing the likelihood of tissue damage. The stimulation threshold of biphasic stimulation that is administered via the bloodstream is within the range as is a standard stimulus delivered directly to the heart muscle.

Therefore, by using biphasic electrical stimulation with the cardiac bloodstream, it is possible to obtain increased cardiac contraction, without skeletal muscle contraction, cardiac muscle damage or adverse effects to the bloodstream.

In a third aspect of the invention, biphasic electrical stimulation is applied to striated muscle tissue. The combination of cathodic and anodic stimulation results in the contraction of a greater number of muscular motor units, at a lower voltage level, which results in an improved muscular response.

Having thus described the basic concept of the invention, it will be quite obvious to those skilled in the art that the above detailed description is intended to be presented by way of example only, and is not limiting. Various alterations, improvements and modifications will be presented and attempted by those skilled in the art, but are not expressly presented here. These alterations, modifications and improvements are intended only to suggest hereby, within the scope and spirit of the invention. In addition, the rhythm regulation pulses described in this specification are well within the existing capabilities in terms of the electronic appearance of the steps mark with the appropriate programming. Accordingly, the invention is limited only by the following claims and equivalents of the same. It is noted that in relation to this date, the best method known to the applicant, to carry out the aforementioned invention, is that which is clear from the present description of the invention. Having described the invention as above, property is claimed as contained in the following:

Claims (46)

1. A method for regulating the electrical heart rate characterized in that it comprises: a means for providing electrical stimulation to the cardiac bloodstream, wherein the means for electrical stimulation has no intimate contact with the cardiac tissue; and applying the biphasic electrical stimulation to the bloodstream for the regulation of the heart rhythm, wherein the electrical stimulation comprises: a first phase of stimulation with a first phase polarity, a first phase amplitude, a first phase form and a first duration of phase; and a second phase of stimulation with a second phase polarity, a second phase amplitude, a second phase form and a second phase duration; where the first phase polarity is pos tive.

2. The method for regulating the electrical heart rate of the rei indication 1, characterized in that the first phase of stimulation and the second phase of stimulation are applied in sequence to the cardiac bloodstream.

3. The method for regulating the electrical heart rate of claim 1, characterized in that the first phase amplitude is at a maximum subthreshold amplitude.

4. The method for regulating the electrical heart rate of claim 3, characterized in that the maximum subthreshold amplitude is around 0.5 to 3.5 volts.

5. The method for regulating the electrical heart rate of claim 1, characterized in that the first phase duration is at least as long as the second phase duration.

6. The method for regulating the electrical heart rate of claim 1, characterized in that the first phase duration is about one to nine milliseconds.

7. The method for regulating the electrical heart rate of claim 1, characterized in that the second phase duration is around 0.2 to 0.9 mi 1 s and second s.

8. The method for regulating the electrical heart rate of claim 1, characterized in that the second phase amplitude is around two to twenty volts

9. The method for regulating the electrical heart rate of claim 1, characterized in that the first phase of stimulation is initiated more than 200 milliseconds after the cycle of a heartbeat is completed.

10. A method for regulating the heart rate characterized in that it comprises: means for supplying electrical stimulation to the bloodstream, where the means for electrical stimulation has no intimate contact with the cardiac tissue; and applying the biphasic electrical stimulation to the bloodstream for the regulation of the heart rhythm, wherein the electrical stimulation comprises: a first phase of stimulation with a first phase polarity, a first phase amplitude, a first phase form and a first duration of phase; and a second phase of stimulation with a second phase polarity, a second phase amplitude, a second phase form and a second phase duration; where the first phase amplitude is smaller than the second phase amplitude.

11. A method for regulating the electrical heart rate characterized in that it comprises: means for supplying electrical stimulation to the bloodstream, where the means for electrical stimulation has no intimate contact with the cardiac tissue; and applying biphasic electrical stimulation to the cardiac bloodstream to regulate the cardiac rhythm, wherein the electrical stimulation comprises: a first phase of stimulation with a first phase polarity, a first phase amplitude, a first phase form and a first phase duration; and a second phase of stimulation with a second phase polarity, a second phase amplitude, a second phase form and a second phase duration; where the first phase amplitude increases in ramp from a baseline value to a second value.

12. The method for regulating the electrical heart rate of claim 11, characterized in that the second value is equal to the second phase itude.

13. The method for regulating the electrical heart rate of claim 11, characterized in that the second value is at a maximum subthreshold itude.

14. The method for regulating the electrical heart rate of claim 13, characterized in that the maximum subthreshold itude is around 0.5 and 3.5 volts.

15. The method for regulating the electrical heart rate of claim 11, characterized in that the first phase duration is at least as long as the second phase duration.

16. The method for regulating the electrical heart rate of claim 11, characterized in that the first phase duration is around one to nine milliseconds.

17. The method for regulating the electrical heart rate of claim 11, characterized in that the second phase duration is around 0.2 and 0.9 milliseconds.

18. The method for regulating the electrical heart rate of claim 11, characterized in that the second phase itude is around two and twenty volts.

19. The method for regulating the electrical heart rate of claim 11, characterized in that the second phase duration is less than 0.3 milliseconds and the second phase itude is greater than twenty volts.

20. A method for regulating the electrical heart rate characterized in that it comprises: means for supplying the electrical stimulation to the cardiac bloodstream, where the means for electrical stimulation has no intimate contact with the cardiac tissue; and applying the biphasic electrical stimulation to the cardiac bloodstream for the regulation of the heart rhythm, where the electrical stimulation comprises: a first phase of stimulation with a first phase polarity, a first phase itude, a first phase form and a first duration of phase; and a second phase of stimulation with a second phase polarity, a second phase itude, a second phase form and a second phase duration; where the second phase duration is less than 0.3 milliseconds and the second phase itude is greater than twenty vol 11 ios.

21. A method for regulating the electrical heart rate characterized in that it comprises: means for supplying electrical stimulation to the cardiac bloodstream, where the means for electrical stimulation has no intimate contact with the cardiac tissue; and applying biphasic electrical stimulation to the cardiac bloodstream to regulate the cardiac rhythm, wherein the electrical stimulation comprises: a first phase of stimulation with a first phase polarity, a first phase itude, a first phase form and a first duration of phase; and a second phase of stimulation with a second phase polarity, a second phase itude, a second phase form and a second phase duration; wherein the first stimulation phase further comprises a series of stimulation pulses of predetermined itude, polarity and duration; and where the first phase of stimulation also comprises a series of periods at rest.

22. The method for regulating the electrical heart rate of claim 21, characterized in that applying the first stimulation phase further comprises applying a resting period of a baseline itude after at least one stimulation pulse.

23. The method for regulating the electrical heart rhythm of the rei indication 22, characterized in that the period at rest is of equal duration to the duration of the stimulation pulse.

24. An apparatus for regulating the electrical heart rate, the apparatus comprises: conductors for applying electrical stimulation to the bloodstream; and a stimulation generator connected to the conductors, characterized in that the stimulation generator produces a biphasic electric waveform, to stimulate the cardiac blood stream via the conductors to effect the regulation of the heart rhythm, the electric waveform comprises: a first stimulation phase with a first phase polarity, a first phase itude, a first phase form and a first phase duration; and a second phase of stimulation with a second phase polarity, a second phase amplitude, a second phase form and a second phase duration; where the first phase polarity is po s i t i va.

25. The apparatus for regulating the electrical heart rate of rejection 24, characterized in that the first stimulation phase and the second stimulation phase are sequentially applied to the cardiac bloodstream.

26. The apparatus for regulating the electrical heart rate of claim 24, characterized in that the first phase amplitude is at a maximum subthreshold amplitude.

27. The apparatus for regulating the electrical heart rate of claim 26, characterized in that the maximum subthreshold amplitude is around 0.5 to 3.5 volts.

28. The apparatus for regulating the electrical heart rate of claim 24, characterized in that the first phase duration is at least as long as the second phase duration.

29. The apparatus for regulating the electrical heart rate of claim 24, characterized in that the first phase duration of is about one to nine milliseconds.

30. The apparatus for regulating the electrical heart rate of claim 24, characterized in that the second phase duration is around 0.2 to 0.9 milliseconds.

31. The apparatus for regulating the electrical heart rate of claim 24, characterized in that the second phase amplitude is from about two to twenty volts.

32. The apparatus for regulating the electrical heart rate of claim 24, characterized in that the first stimulation phase is initiated more than 200 milliseconds after the completion of a heartbeat cycle.

33. An apparatus for regulating the electrical heart rate, the apparatus comprises: conductors for applying electrical stimulation to the cardiac bloodstream; and a stimulation generator connected to the conductors, characterized in that the stimulation generator produces a biphasic electric waveform, to stimulate the cardiac blood stream via the conductors to effect the regulation of the heart rhythm, the electric waveform comprises: a first stimulation phase with a first phase polarity, a first phase amplitude, a first phase form and a first phase duration; and a second phase of stimulation with a second phase polarity, a second phase amplitude, a second phase form and a second phase duration; where the first phase amplitude is lower than the second phase amplitude.

34. An apparatus for regulating the electrical heart rate, the apparatus comprises: conductors for applying electrical stimulation to the bloodstream; and a stimulation generator connected to the conductors, characterized in that the stimulation generator produces a biphasic electric waveform to stimulate the bloodstream via the conductors to effect the regulation of the heart rhythm, the electric waveform comprising: a first phase of stimulation with a first phase polarity, a first phase amplitude, a first phase form and a first phase duration; and a second phase of stimulation with a second phase polarity, a second phase amplitude, a second phase form and a second phase duration; where the first phase amplitude increases in ramp from a baseline value to a second value.

35. The apparatus for regulating the electrical heart rate of claim 34, characterized in that the second value is equal to the second phase amplitude.

36. The apparatus for regulating the electrical heart rate of claim 34, characterized in that the second value is at a maximum sub-threshold amplitude.

37. The apparatus for regulating the electrical heart rate of claim 36, characterized in that the maximum subthreshold amplitude is around 0.5 to 3.5 volts.

38. The apparatus for regulating the electrical heart rate of claim 34, characterized in that the first phase duration is at least as long as the second duration of phase.

39. The apparatus for regulating the electrical heart rate of the indication rei 34, characterized in that the first phase duration is around one and nine milliseconds.

40. The apparatus for regulating the electrical heart rate of claim 34, characterized in that the second phase duration is about 0.2 to 0.9 mi 1 s seconds.

41. The apparatus for regulating the electrical heart rate of claim 34, characterized in that the second phase amplitude is from about two to twenty volts.

42. The apparatus for regulating the electrical heart rate of claim 34, characterized in that the second phase duration is less than 0.3 milliseconds and the second phase amplitude is greater than 20 volts.

43. An apparatus for regulating the electrical heart rate, the apparatus comprises: conductors for applying electrical stimulation to the cardiac bloodstream; and a stimulation generator connected to the conductors, characterized in that the stimulation generator produces a biphasic electric waveform, to stimulate the cardiac bloodstream via the conductors, to effect the regulation of the heart rhythm, the electric waveform comprising: first phase of stimulation with a first phase polarity, a first phase amplitude, a first phase form and a first phase duration; and a second phase of stimulation with a second phase polarity, a second phase amplitude, a second phase form and a second phase duration; where the second phase duration is less than 0.3 milliseconds and the second phase amplitude is greater than 20 volts.

44. An apparatus for regulating the electrical heart rate, the apparatus comprises: conductors for applying electrical stimulation to the cardiac bloodstream; and a stimulation generator connected to the conductors, characterized in that the stimulation generator produces a biphasic electric waveform, to stimulate the cardiac bloodstream via the conductors, to effect the regulation of the heart rhythm, the electric waveform comprising: first phase of stimulation with a first phase polarity, a first phase amplitude, a first phase form and a first phase duration; and a second phase of stimulation with a second phase polarity, a second phase amplitude, a second phase form and a second phase duration; and wherein the first stimulation phase further comprises a series of predetermined amplitude, polarity, and duration stimulation pulses; and where the first phase of stimulation also includes a series of periods at rest

45. The apparatus for regulating the electrical heart rate of claim 44, characterized in that the application of the first stimulation phase further comprises applying a resting period of a baseline amplitude, after at least one stimulation pulse.

46. The apparatus for regulating the electrical heart rate of claim 45, characterized in that the rest period is of equal duration to the duration of the stimulation pulse.