MXPA04001784A - Treatment of oropharyngeal disorders by application of neuromuscular electrical stimulation. - Google Patents

Abstract

A method for treating an oropharyngeal disorder in a patient by neuromuscular electrical stimulation includes selectively placing a plurality of electrodes in electrical contact with tissue of a pharyngeal region of the patient. The method also includes the steps of providing a pulse generator for generating a series of electrical pulses, each of which comprises a biphasic symmetrical waveform with an interval between the two phases, and attaching the plurality of electrodes to the pulse generator so that the series of electrical pulses may be provided to the patient through the plurality of electrodes. According to the method, a series of electrical pulses, each of which comprises a biphasic symmetrical waveform with an interval between the two phases, is generated, and said series of electrical pulses is provided to the patient through the plurality of electrodes. An apparatus for generating a series of electrical pulses for application of electrical neuromuscular stimulation to a p atient through a plurality of electrodes for treatment of oropharyngeal disorders includes a pulse generator which generates a series of electrical pulses, each of which pulses comprises a biphasic symmetrical waveform with an interval between the two phases. The apparatus includes an intensity control circuit for regulating the series of electrical pulses such that the intensity of the electrical pulses does not exceed a predetermined value, a frequency controller for controlling the frequency at which the series of electrical pulses is generated so that such pulses are generated at a predetermined frequency, and a duration control circuit for controlling the duration of each such electrical pulse.

Description

TREATMENT OF OROPHARINOGENIC AFFECTIONS THROUGH THE APPLICATION OF NEUROMUSCULAR ELECTRICAL STIMULATION RELATED PETITIONS This petition is a continuation in part of the U.S. Patent Request. Serial No. 10 / 375,407, which was filed on February 27, 2003, which is a continuation in part of the Petition in U.S. Serial No. 10 / 308,105, filed on December 3, 2002 (now abandoned), which is a continuation of the Petition in U.S. Serial No. 09 / 757,804, filed on January 11, 2001 (now abandoned), which is a continuation of the Petition in U.S. Serial No. 09 / 236,829, filed on January 25, 1999 (now U.S. Patent No. 6,148,970), which is a continuation in part of the Petition in U.S. Serial No. 08 / 956,448, filed on October 23, 1997 (now U.S. Patent No. 5,987,351), which is a continuation of the Petition in U.S. Serial No. 08 / 549,046, filed October 27, 1995 (now U.S. Patent No. 5,725,564).

FIELD OF THE INVENTION This invention relates to a method and apparatus for the treatment of oropharyngeal conditions. In particular, the present invention relates to a method and apparatus for the treatment of oropharyngeal conditions by the provision of neuromuscular electrical stimulation in the pharyngeal region of the patient.

BACKGROUND OF THE INVENTION Asymptomatic and symptomatic oropharyngeal conditions can lead to an inability to swallow or difficulty swallowing. These conditions may be caused, for example, by neurodegenerative conditions, stroke, brain tumors or respiratory conditions.

Swallowing is a complicated action by which food goes from the mouth along the pharynx and esophagus to the stomach. The act of swallowing can be initiated voluntarily or reflexively but always ends reflexively. The act of swallowing occurs in three stages and requires an integrated action of the respiratory and motor functions of multiple cranial nerves, and the coordination of the anatomical system within the esophagus. In the first stage, the food or some other substance is placed on the surface of the tongue. The tip of the tongue is placed against the hard palate. The elevation of the larynx and the backward movement of the tongue force the food along the isthmus of the jaws into the pharynx. In the second stage, the food passes-along the pharynx. This involves the constriction of the walls of the pharynx, the backward bending of the epiglottis, and an upward and forward movement of the larynx and trachea. Food is prevented from entering the nasal cavity by raising the soft palate and entering the larynx closing the glottis and the backward inclination of the epiglottis. During this stage, respiratory movements are inhibited by reflex action. In the third stage, the food goes down the esophagus and enters the stomach. This movement is carried out by the impulse from the second stage, peristaltic contractions, and gravity.

Although the main function of swallowing is the propulsion of food from the mouth to the stomach, swallowing also serves as a reflex protection for the upper respiratory tract by moving particles enclosed in the nasopharynx and oropharynx, returning to the stomach materials that have refluxed the stomach. pharynx, or moving particles propelled from the upper respiratory tract to the pharynx. Therefore, if you do not swallow adequately reflects there is a large increase in the likelihood of pulmonary aspiration.

In the past, patients suffering from oropharyngeal conditions had been undergoing treatment of dietary changes or thermal stimulation to recover the reflexes of swallowing properly. Thermal stimulation is about immersing a mirror or probe in ice or another cold substance and stimulating the tonsil fossa with the mirror or the cold probe. After such stimulation, the patient is instructed to close his mouth and try to swallow. Although dietary changes and rehabilitation with exercise using thermal stimulation may be effective for the treatment of oropharyngeal conditions, some patients may need weeks or months of therapy. It is also difficult to distinguish patients who need such treatments from patients who recover spontaneously.

Muscle fibers are generally characterized as Type I or Type?, Depending on their rate of contraction, endurance and resistance to fatigue and other characteristics. Type I muscle fibers are characterized by slow contraction rhythms, high endurance, slowness to fatigue and low strength. On the other hand, the muscle fibers of Type? They are characterized by rapid contraction rhythms, low endurance, rapidity for fatigue and high strength. All muscles have both types of fibers, and several of the muscles involved in swallowing contain a higher proportion of Type II fibers. It is believed that the high speed and dynamic and strong action of swallowing is due to this preponderance of Type? Fibers.

Most conditions treated in therapy are characterized by a degree of disuse atrophy. Disuse atrophy refers to changes in the muscle after a period of immobilization or reduced activity. The most obvious change is a decrease in the area of the cross section of the muscular belly, with Type? affected to a greater degree than Type I fibers. Swallowing musculature shows these typical changes with disuse, but the impact on these muscles is relatively greater because the total percentage of Type II fibers is higher. During the rehabilitation exercise, Type I fibers are first contracted, while larger Type II fibers only intervene when the effort increases. Therefore, Type I fibers receive the greatest benefit of exercise rehabilitation. On the other hand, during the electrical stimulation, Type? they are the first to contract, whereas Type I fibers only contract afterwards when the width and pulse intensity increase above a certain threshold. Therefore, electrical stimulation preferably trains Type II fibers.

Neuromuscular electrical stimulation (NMES) has been used to relieve pain and stimulate nerves, as well as a means to treat conditions of the spinal cord or peripheral nervous system. Neuromuscular electrical stimulation (as well as muscle electrical stimulation) has been used more to facilitate muscle reeducation and other physical therapy treatments. In the past, neuromuscular electrical stimulation or electrical muscle stimulation were not indicated for use on the neck because it worried that the patient could develop spasms of the muscles of the larynx, resulting in the closure of the airway or difficulty in breathing, and / or concern that the introduction of electrical current in the neck near the carotid body may cause bradycardia and subsequent hypotension.

More recently, neuromuscular electrical stimulation has been used for stimulation of the recurrent laryngeal nerve to stimulate the laryngeal muscles to control the opening of the vocal cords, to overcome the paralysis of the vocal cords, to aid in the evaluation of the function of the cords vowels, to help with the shoring, and other related uses.

Generally, there have been no adverse reactions with such treatment techniques. However, neither neuromuscular electrical stimulation nor electrical muscle stimulation have been used in the treatment of oro-pharyngeal affections to promote the swallowing reflex, which implies the integrated action of the functions of the respiratory center and the motor functions of multiple cranial nerves.

It would be desirable to provide a simple, non-invasive method and apparatus for the treatment of oropharyngeal conditions and to help swallow effectively within a relatively short treatment period.

ADVANTAGES OF THE INVENTION Among the advantages of the invention is that it provides a simple, non-invasive method and apparatus for the treatment of oropharyngeal conditions and to help swallow by providing electrical stimulation to the pharyngeal region of a human patient.

Other advantages of this invention will be apparent upon examination of the drawings and the description that follows.

EXPLANATION OF THE TECHNICAL TERMS As used herein, the term "electrical muscle stimulation" refers to the use of electrical stimulation for direct muscle activation of denervated muscle fibers in the absence of peripheral innervation.

As used herein, the term "neuromuscular electrical stimulation" refers to the use of electrical stimulation for the activation of muscles by stimulation of the intact peripheral motor nerves.

As used herein, the term "pharyngeal region" refers to the anterior part of the neck limited in the upper part by the jaw and in the lower part by the clavicles and the sternum handlebar.

SUMMARY OF THE INVENTION The invention consists of a method for the treatment of an oropharyngeal condition in a patient by electrical neuromuscular stimulation. According to this method, a plurality of electrodes are selectively placed in electrical contact with the tissue of a pharyngeal region of the patient, and a pulse generator is provided to generate a series of electrical pulses, each of which consists of a of biphasic symmetric wave with an interval between the two phases. A plurality of electrodes is attached to the pulse generator so that the series of electrical pulses can be supplied to the patient by the plurality of electrodes, and a series of electrical pulses are generated, each of which consists of a symmetrical waveform biphasic with an interval between the two phases. The series of electrical pulses is supplied and transmitted to the patient by means of the plurality of electrodes.

The invention also consists in apparatus for generating a series of electrical pulses, each of these pulses consists of a biphasic symmetrical waveform with a gap between the two phases, for the application of neuromuscular stimulation. to a patient by a plurality of electrodes for the treatment of oropharyngeal conditions. The apparatus consists of a pulse generator that includes a current control circuit to regulate the series of electrical pulses so that the intensity of the electrical pulses does not exceed a predetermined value, a frequency controller to control the frequency at which it generates the series of electrical pulses so that such pulses are generated at a certain frequency, and a circuit of duration control to control the duration of each electrical pulse.

A preferred apparatus for the treatment of oropharyngeal conditions according to the present invention also includes a first pair of electrodes and a second pair of electrodes. This preferred apparatus includes a first pulse generator that is adapted to generate a first series of electrical pulses (each of which consists of a two-phase symmetric waveform with a gap between the two phases) for output on a first channel and . the first pair of electrodes, and a second pulse generator that is adapted to generate a second series of electrical pulses (each of which consists of a biphasic symmetric waveform with an interval between the two phases) for output for a second channel and the second pair of electrodes. The first pulse generator of this embodiment also includes a first intensity control circuit for the regulation of the series of electrical pulses for the output by the first channel so that the electric current does not exceed a first predetermined value, and the second generator The pulse includes a second current control circuit for regulating the series of electrical pulses for the output by the second channel so that the electrical current does not exceed a second predetermined value. Each of the preferred pulse generators of this embodiment also includes a frequency counter to control the frequency at which the series of electrical pulses is generated by the pulse generator so that the pulses are generated at a predetermined frequency, and a duration control circuit to control the duration of each of these electrical pulses.

In a preferred embodiment of the invention, each of the electrodes includes an instantaneous opening, a conductive film and a layer of adhesive and conductive gel. The instantaneous opening has a first side and a second side, and the second side has a connector to which a lead wire can be connected. The conductive film is connected to the first side of the instantaneous aperture, and the adhesive and conductive gel layer is connected to the conductive film and is adapted to be held on the skin of the patient. The preferred embodiment of the invention also includes at least one reinforcing tape cover for securing the electrodes to the patient's skin.

To facilitate an understanding of the invention, the preferred embodiments of the invention are illustrated in the drawings, and a detailed description thereof follows. However, it is not intended that the invention be limited to the particular embodiments described or to the use in connection with the apparatus illustrated therein. Also contemplated and include various modifications and alternative embodiments as normally occur to a person skilled in the art to which the invention is related within the scope of the invention described and affirmed herein.

BRIEF DESCRIPTION OF THE DRAWINGS The preferred embodiments of the invention are now illustrated in the accompanying drawings, in which the reference numbers represent parts of the apparatus, and in which: Figure 1 is a schematic diagram of a preferred electrical neuromuscular stimulator according to the present invention for use in the treatment of dysphagia and other oropharyngeal conditions.

Figure 2 is a flow diagram of a preferred method for electrical pharyngeal neuromuscular stimulation according to the present invention to facilitate swallowing.

Figure 3 is a view of a part of the pharyngeal region of a patient showing several exemplary placements of a pair of electrodes according to the present invention.

Figure 4 is a view of a part of the pharyngeal region of a patient showing several exemplary placements of a pair of electrodes according to the present invention.

Figure 5 is a view of the parts of a preferred embodiment of an electrode of the invention.

Figure 6 is an illustration of a preferred waveform of an electrical pulse that is generated in accordance with the preferred embodiment of the invention.

Figure 7 is a diagram of a first embodiment of an electrode system that can be used in relation to (or as a part of) the invention.

Figure 7A illustrates the placement of the electrode system of Figure 7 in the pharyngeal region of a human patient. Figure 7B illustrates the placement in the throat of a patient of a second embodiment of an electrode system that can be used in relation to (or as a part of) the invention.

Figure 7C illustrates the placement of a third embodiment of an electrode system in the throat of a patient in accordance with the preferred embodiment of the invention.

Figure 7D illustrates the placement of a fourth embodiment of an electrode system in the throat of a patient in accordance with the preferred embodiment of the invention.

Figure 7E illustrates the placement of a fifth embodiment of an electrode system in the throat of a patient in accordance with the preferred embodiment of the invention.

Figure 8 is a front view of a preferred reinforcing tape cover for use to secure the electrodes to the skin of a patient according to the invention.

Figure 9 is a side view of the preferred clip forming a part of the preferred embodiment of the invention.

DESCRIPTION OF THE PREFERRED INCORPORATION The present invention will now be described in detail with reference to the accompanying drawings, which are given only as illustrative examples of the preferred embodiments of the invention and not for the purpose of limiting the same. Figure 1 illustrates a preferred embodiment of an electrical neuromuscular stimulation apparatus or apparatus 20 for using it to deliver neuromuscular electrical stimulation in the pharyngeal region of a patient to swallow it. As shown in Figure 1, the neuromuscular electrical stimulation apparatus 20 includes a pulse generator, or more preferably, a first pulse generator 22 and a second pulse generator 24. A single generator can also be provided in the neuromuscular electrical stimulation apparatus of that invention. of pulse or more than two pulse generators. Each of the pulse generators is adapted to generate a series of electrical pulses, wherein each pulse comprises a biphasic symmetric waveform with an interval between the two phases. Preferably, each of the pulses consists of a biphasic rectangular waveform having a gap between the two phases of opposite polarity, as illustrated in Figure 6.

The device 20 also includes one or more intensity control circuits for regulating the series of electrical pulses generated by each of the pulse generators so that the intensity of the electrical pulses does not exceed a predetermined value, such as, for example, regulating the series of electrical pulses so that the electric current does not exceed 25 milliamperes RMS. Preferably, an intensity control circuit will be provided for each pulse generator. In this way, as shown in Figure 1, the intensity control circuit 26 is related to the first pulse generator 22 and the intensity control circuit 28 is related to the second pulse generator 24. It can also be provided an intensity control circuit to ensure that the energy of the electrical pulses generated by each pulse generator does not exceed a predetermined value and / or to ensure that the voltage of the electrical pulses generated by each pulse generator does not exceed a predetermined voltage. In a preferred embodiment, the intensity control circuits 26 and 28 limit the values of the current, energy and / or output voltage of the electrical pulses by means of the pulse generators 22 and 24 using conventional limiting circuits. The values of the predetermined current, energy and / or voltage may vary according to the physical condition of the patient and to the tolerances and treatments performed. For example, in treatments of oropharyngeal conditions, the applied current must be sufficient to produce the desired response and help the swallowing reflex. Generally, the outputs of current intensity, energy and / or voltage are determined to produce the desired response while providing greater patient comfort and minimizing as much as possible the degree of the pinprick sensation felt by the patient. the patient. However, the intensity of the pulses applied should not be large enough to assume any risk of laryngeal spasms and bradycardia in the patient. Good results have been obtained when the pulse generators 22 and 24 are controlled by intensity control circuits 26 and 28 to generate a series of electrical pulses at a current less than or equal to about 25 mA. The intensity of the current normally starts at a level of about 0.5 mA and increases in small increments of preferably about 0.5 mA each until the swallowing or muscle fasciculation response occurs.

The current control circuit may also contain a voltage controller that can be used to regulate the voltage of the electrical pulses generated by each pulse generator so that such voltage does not exceed a predetermined value, such as about 100 V. The current control circuit may also have an energy controller that can be used to regulate the energy of the electrical pulses generated by each pulse generator so that such energy does not exceed a predetermined value, such as, for example, 2500 mW.

The preferred device also includes a frequency controller for controlling the frequency at which each pulse generator generates the series of electrical pulses so that such pulses are generated at a predetermined frequency. In this way, as shown in Figure 1, the frequency controller 30 is related to the pulse generator 22 and the frequency controller 32 is related to the pulse generator 24. The frequency controller modulates the electrical signal generated by the pulse generator at a predetermined frequency to produce the series of electrical output pulses by the pulse generator. The frequency controller can modulate the electrical signal at a fixed frequency, for example, 80 Hertz. In the alternative, the frequency controller may vary the frequency of the electrical pulses within a predetermined frequency range, for example, a frequency range of 30 to 100 Hertz, or it may allow an operator to set the frequency at a specific frequency within a predetermined range. Other frequency ranges which are known to those familiar with the normal technique to which the invention is related can also be used. Generally, the frequency of the electrical pulses will be. It selects to provide the desired response along with the greater well-being for the patient and to minimize as much as possible the degree of pricking sensation felt by the patient.

The device 20 includes a duration control circuit and an associated timer to control the duration (or pulse width) of each electrical pulse generated by a pulse generator. In this way, for example, the duration control circuit 34 and the timer 36 are associated with the pulse generator 22 and the duration control circuit 38 and the timer 40 are associated with the pulse generator 24. In A preferred embodiment of the invention, the pulse generator generates electrical pulses of a biphasic symmetric waveform and the duration control circuit controls the total pulse duration of each of such pulses from about 550 microseconds to about 850 microseconds. , with an interphase interval of around 50 up to about 150 microseconds. More preferably, as illustrated in Figure 6, the duration control circuit controls the duration of each electrical pulse so that each pulse has a total pulse duration of about 700 microseconds, comprising a first phase duration of about 300 microseconds, an interface interval of around 100 microseconds and a second (opposite polarity) phase duration of about 300 microseconds. Referring again to Figure 1, the duration control circuits 34 and 38 can be adjusted manually or automatically using conventional timing circuits, such as the timer 36 (for circuit 34) and the timer 40 (for circuit 38). ).

In a preferred embodiment, the chronometers can also be used to selectively control the amount of time during which the electrical pulses are applied. In this way, for example, chronometers can be used to apply electrical pulses in each treatment cycle during a period ranging from 0.5 seconds to 30 seconds. Other durations may also be used as those familiar with the technique to which the invention is related know. In the alternative, the time of the treatment cycle can be left for the operator to control, so that the electrical pulses can be generated continuously and can be delivered to the electrodes until a satisfactory contraction of the musculature to swallow is achieved or until the patient's sensory tolerance level is reached. The chronometers can also be used to control the time between the treatment cycles, as well as the treatment time for a particular treatment session, or the total duration of time during which the pulse generators generate electric pulse cycles, including the separation time between such cycles. For example, chronometers can be set to provide a separation between treatment cycles ranging from 0.1 second to 60.0 seconds, or other appropriate separation times. The treatment time for a particular treatment session can be set at any suitable period, such as fifteen, thirty, or sixty minutes, p. Control function of the treatment time can allow the continuous treatment controlled manually. As with all adjustments, the particular values are highly specific for the application and the patient. In addition, the chronometers can also control the amount of time necessary to reach the maximum intensity in each treatment session, such as, for example, the time during which the intensity of the current increases, in increments of around 0.5 mA (u another adequate increase), from an initial level of around 0.5 mA (or another suitable level) to a final level of around 25 mA (or another one of adequate mvel). Similarly, chronometers can also control the period of time necessary to decrease the intensity from maximum intensity to zero (or another appropriate level, if desired) at the end of each treatment session.

In a preferred embodiment of the invention, a channel or system change selector serves for the activation of one or more electrodes or series of electrodes by which the electric pulses can be supplied to the patient, using conventional change circuits. Thus, for example, a channel selector can provide simultaneous activation of two pairs of electrodes through two pairs of output paths. In the embodiment illustrated in Figure 1, the channel selector 42 can be used to activate a first pair of tracks 44a and 44b and a second pair of tracks 44c and 44d. The electrical pulses of the generator 22 can be transmitted via the channel selector 42, via the tracks 44a and 44b to the electrodes 50a and 50b by the conductor lines 46a and 46b respectively. Preferably, the current of the pulses transmitted by the output paths 44a and 44b can be regulated within the range of 0.5 to 25 milliamperes in increments of 0.5 milliamperes. Likewise and independently, the current of the pulses generated by the generator 24 can be transmitted by the channel selector 42 to the electrodes 50c and 50d by the conductive lines 46c and 46d respectively. Preferably, the current of the pulses transmitted by the output paths 44c and 44d can be regulated within the range of 0.5 to 25 milliamperes in increments of 0.5 milliamperes. It is contemplated within the scope of the invention that the current can be set at the same or different levels for output by the different channels.

As shown in Figure 1, the preferred device 20 includes two pairs of electrodes 50a and 50b, and 50c and 50d, although other series of electrodes related to the invention may also be employed. For human applications, the electrodes 50 are preferably rapid electrodes having a construction as illustrated in Figure 5 (described in more detail below). Preferably, as shown in the drawings, the electrodes of each pair are of equal size, so that they are not considered to be dispersive for the load or that the current is transmitted by them.

At least one conductor cable is provided for each electrode. Each of the conductor cables has a connection end of the electrode to connect it to an electrode and one end of the output path to connect it to the pulse generator (or to connect it to the pulse generator by means of a channel selector) . These connection ends can be. conventional designs or any design that is appropriate for the connection of an electrode to an output path of or related to a pulse generator, as deemed appropriate by those familiar with the normal technique to which the invention is related. Thus, as shown in Figure 1, the lead wire 46a has a connecting end of the electrode that is attached to the electrode 0a and one end of the outlet path that is attached to the outlet end 44a of the channel selector 42 Likewise, the lead wire 46b has an electrode connecting end that is attached to the electrode 50b and one end of the output path that is attached to the output path 44b, and the lead wire 46c has a connecting end electrode that is attached to the electrode 50c and one end of the outlet path that is attached to the exit path 44b, and the lead 46d has an electrode connection end that is attached to the electrode 50d and one end of the way of exit that is subject to the exit route 44d. The connector cables 46a, 46b, 46c and 46d can be made of any physiologically acceptable conductive metal, preferably insulated aluminum and copper wire. Multi-wire cables are preferable to "wire wrap" cables because the multi-wire cable is more flexible and less likely to break with repeated bending.

The preferred electrode 50 is illustrated in some detail in Figure 5. As shown therein, the preferred electrode 50 has a metal snap opening 52 having a first side 54 and a second side 56. The first side of each preferred instantaneous opening is generally circular and has a diameter of about 7 mrn. The second side has a clamping shaft connector 58 to which a conductor cable can be fastened. The preferred electrode also includes a generally circular conductive film 60 having a diameter within the range of 16mm-22mm that is attached to the first side of the instantaneous aperture. Preferably, the conductive films of the lower end of this size range, or the small size films, are used in electrodes intended for applications to children, while the upper end of the preferred range, or large size films, are used in electrodes designed for adult applications. As used herein, the term "conductive film" refers to a thin substrate that is conductive of electricity. Preferably, the film is a carbon film having a thickness of approximately 0.10 mm. However, those who are familiar with the normal technique with which this invention relates know other conductive substrates that can also be used. The preferred electrode also includes a layer of adhesive and conductive gel 62, preferably a crosslinked hydrogel having a thickness of approximately 1.0 mm, which is attached to the conductive film and adapted to be attached to the skin of the patient. For the application of the electrodes to children, high adhesiveness versions of the adhesive gel layer are preferable for the relatively small area of contact with the skin. A suitable high adhesive adhesive gel known as RG-72 is available from Promeon Company. The preferred electrode also includes an emission liner 64 that is secured to the gel cap to protect it before application to the patient's skin. Preferably, the emission liner is made of polyester or other suitable material having an approximate thickness of 0.125-mm. The electrode of the invention may also include a layer of conductive bonding tape 66, which has a hole for the holding shaft, which is adapted for attachment to the safest opening 52 to the conductive film 60. A layer may also be provided of electrical insulation 68 for superimposing on the layer of conductive bonding tape, or if there is no such layer, to the same opening. The insulating layer will also include a hole through which the clamping shaft can protrude. The preferred results have been obtained when the maximum electrical impedance of the electrode is about 150 ohms.

A preferred embodiment of the invention, as illustrated in the drawings, is sold under the registered trademark "VitalStim" by the Chattanooga LP Group's Encoré Medical Division, which is located in Chattanooga, Tenn. The apparatus "VitalStim" includes a pair of pulse generators, each of which is adapted to generate a series of electrical pulses by transmission to a patient by means of a channel selector and a pair of electrodes. The pulses generated by each of the pulse generators of the "VitalStim" device are waveforms. rectangular biphasic symmetries that have a total pulse duration of about 700 microseconds including an interphase interval of about 100 microseconds.

As shown in Figures 3 and 4, in an embodiment of two electrodes to the present invention, a pair of electrodes 202a and 202b may be placed in the skin of the pharyngeal region 200 in the approximate position of the minor horn of the hyoid bone. on either side of the pharyngeal region 200 and just above the body of the hyoid bone. In this arrangement, the electrodes overload the muscles of the floor of the mouth. In an alternative two-electrode embodiment of the present invention, a pair of electrodes 208a and 208b may be placed on the side of the pharyngeal region 200 on one side of. the midline of the pharyngeal region 200. In this embodiment of the invention, the electrode 208a is placed on the thyrohyoid membrane 210 at the approximate level of the horn lesser horn 204, to overload the sternohyoid muscle and the thyrohyoid muscle 214, the electrode 208b it is placed in the cricoid cartilage 26 adjacent to the midline of the pharyngeal region 200, to overload the stemotyroid muscle 217 and the sternohyoid muscle on one side of the midline of the fíf- netngeal region. In another embodiment of the present invention, a pair of electrodes 220a and 220b can be placed on the skin of the pharyngeal region 200 on the thyroid membrane 210 on either side of the midline of the pharyngeal region 200. In this arrangement, these electrodes overload the thyroid muscle 214 and the sternohyoid muscle 218. In another embodiment of the present invention, a pair of electrodes 222a and 222b can be placed on the skin in the pharyngeal region 200 on either side of the midline of the pharyngeal region 200 approximately at half way between the thyroid notch 224 and the cricoid cartilage 216. In this arrangement, these electrodes overload the sternohyoid muscle 218 and the transition zone between the stemotiroid muscle and the thyroid muscle on either side of the midline of the pharyngeal region 200.

In a further embodiment of the present invention, a pair of electrodes 226a and 226b can be placed on the skin of the pharyngeal region 200 on one side of the midline of the pharyngeal region 200. In this embodiment, an electrode 226a is placed just laterally to the lower horn of the hyoid bone 204 approximately midway between the hyoid bone 204 and the lower edge of the mandible (not shown), to overload the mylohyoid muscle 228 and the digastric muscle 230. In this embodiment, the other electrode 226b is it places near the upper end of the thyroid membrane 210 and near the hyoid bone 204 or in the hyoid bone 204 near the level of the horn lesser of the hyoid bone 204, to overload the estemohyoid muscle 218 and the thyroid muscle. In another embodiment of the present invention (Figure 4), a pair of electrodes 232a and 232b can be placed on the skin of the pharyngeal region 200 next to the midline of the pharyngeal region 200. In this arrangement, an electrode 232a is placed in the midline of the pharyngeal region near the chin (not shown), and the electrode 232b is placed laterally to the other electrode. These electrodes overload the mylohyoid muscle 228 and the digastric muscle 230 in the midline and to one side of the midline of the pharyngeal region 200. In general, the placement and size of the electrodes is selected according to the present invention to avoid carotid body and to ensure patient safety.

In Figure 7 there is shown an incorporation of a series of electrodes that is suitable for use in conjunction with the electrical stimulation apparatus 20 for the treatment of oropharyngeal conditions. Each series of electrodes 607 stimulates one or more pharyngeal muscles with electrical stimulation provided by a pulse generator of the apparatus 20. The arrangement of the electrodes and connecting leads shown in Figure 7 is provided as an example and is not intended to limit the scope of the present invention. Multiple electrodes can also be used, including square series of four, sixteen, twenty-five, or thirty-six or more electrodes, or vertically arranged pairs of two or four electrodes. As the number of electrodes increases, the surface area treated by the series of electrodes can increase and / or the electrodes can be placed closer. As shown in Figure 7, series 607 preferably comprises four electrodes 701, 702, 703 and 704, which are placed on the tissue of the pharyngeal region of a patient using adhesive tapes 705 and 706 as shown in Figure 7A, or more preferably, with a pair of reinforcing tape covers as shown in Figure 8 (and described later in more detail). The adhesive tapes illustrated in Figure 7 and 7A for securing each pair of electrodes in the series 607 to the patient can have a width of approximately eight centimeters, shown as the distance "A" in Figure 7. The pads are also provided. of contact 707 and 708 having a width of approximately eight and a half centimeters (shown as distance "B" in Figure 7). In embodying the invention illustrated in Figures 7 and 7A, the electrodes are preferably placed in two vertical pairs, each para to a lateral side (eg, on the right hand or left hand side) of the pharyngeal region of the patient, with one electrode placed above the Adam's apple of the patient and the other under the Adam's apple of the patient. The first pair of electrodes, 701 and 703, is placed on the left side of the patient (the right side of Figures 7 and 7A). The second pair of electrodes, 702 and 704, is placed in the same arrangement on the opposite side of the pharyngeal region of the patient, each pair of electrodes can preferably be placed so that the distance between the centers of the electrodes of each pair, shown as distance "X" in Figure 7, it may be approximately three or four centimeters or another separation that requires placing the electrodes in the pharyngeal region of the patient as described above.The electrodes of each pair may be spaced preferably at a distance, shown as "Y" distance in Figure 7, approximately two and a half centimeters or other distance that is necessary to place the electrodes in the pharyngeal region of the patient as described above In the arrangement of the two electrode pairs described above up, the two electrodes 701 and 703 which are placed on a lateral side (eg, right or left side) of the patient's pharyngeal region they are coupled with a first output channel of the apparatus 20, and the two electrodes 702 and 704 which are placed on the other lateral side of the pharyngeal region of the patient are coupled with a second output channel of the apparatus. In the embodiment of Figures 7 and 7 A, the electrodes 701, 703, 702 and 704 of the series of electrodes 607 can each be independently coupled with an output path (44a, 44b, 44c and 44d, respectively) of the selector of channel 42 by lead wires 710, 711, 712, and 713 respectively. As a result, each pair of electrodes independently receives one or more series of electrical pulses generated by one of the pulse generators 22 or 24. It is also contemplated that each electrode (in place of each pair of electrodes) in this electrode array can receive independently one or more series of electrical pulses generated by the pulse generator.

Another arrangement of electrodes, in two horizontal pairs, is illustrated in Figure 7B. As shown therein, a first pair of electrodes 714 and 716 is placed horizontally immediately above the thyroid notch. A second pair of electrodes 718 and 720 are placed horizontally below the notch. Preferably, the first pair of electrodes of this series is coupled independently, by a pair of outlet paths, (not shown in Figure 7B) with the channel selector 42 of the apparatus 20 (shown in Figure 1) by means of the conductor wire 722, comprise a pair of electrode connection ends 722a and 722b and a pair of ends of the output path (not shown). Likewise, the second pair of electrodes of this series is preferably coupled independently by a pair of output paths, (not shown in Figure 7B) to the selector channel 42 of the apparatus 20 by means of a lead wire 724, comprise a pair of electrode connection ends 724a and 724b and a pair of output path ends (not shown). As a result, each of these pairs of electrodes independently receives one or more series of electrical pulses generated by one of the pulse generators of the apparatus 20. It is also contemplated that each electrode (instead of each pair of electrodes) of this The electrodes can independently receive one or more series of electrical pulses generated by a pulse generator. As shown in Figure 7B, the connecting wires 722 and 724 can be connected together mechanically to facilitate handling of the joint 725.

In this embodiment of the invention, a pair of reinforcing tape covers 726 is provided to hold the electrodes to the patient's skin. The tape-726 (also shown in Figures 7C, 7D, 7E and 8) are preferably provided with a shape that will allow tight fitting to the skin of the patient's neck both in the horizontal orientation shown in Figures 7B and 7C and in the vertical orientation shown in Figures 7D and 7E. The plaster 726 is also preferably provided with an exterior surface that does not absorb moisture and a groove located in the center 728 that can be aligned over the instantaneous aperture connectors for the preferred electrodes (shown in Figure 5).

This groove allows the electrodes to be placed on the skin of the patient's neck and clamped with the plaster before the connection of the lead wires of the electrodes. The arrangement of the electrodes illustrated in Figure 7B is suitable for most laryngeal and pharyngeal motor defects. A similar arrangement (not shown) can be employed in which the first pair of electrodes 714 and 716 is placed slightly higher above the throat if it is desired to stimulate the tongue and upper pharyngeal muscles to swallow.

Another arrangement of the electrodes, in a single horizontally arranged pair, is illustrated in Figure 7C. This arrangement is also suitable for the treatment of most laryngeal and pharyngeal motor defects. As shown in Figure 7C, electrodes 730 and 732 are positioned horizontally above the thyroid notch. This pair of electrodes is preferably coupled independently, via a pair of output paths, (not shown in Figure 7C) to the channel selector 42 of the apparatus 20 by means of a lead wire 734, comprising a pair of electrode connection ends 734a and 734b and a pair of output path ends (not shown). As a result, this pair of electrodes independently receives one or more series of electrical pulses generated by one of the pulse generators of the apparatus 20. It is also contemplated that each electrode (instead of each pair of electrodes) in this electrode arrangement can receive independently one or more of the series of electrical pulses generated by a pulse generator. Also provided as shown in Figure 7C is a reinforcing tape cover 716 having a central slot 728 for securing the electrodes to the patient's skin.

Figure 7D illustrates another electrode arrangement that is suitable for the treatment of most laryngeal and pharyngeal motor defects. As shown therein, electrodes 736 and 738 are both placed above the thyroid notch in a vertical disposition, generally over the central line of the throat. This pair of electrodes is preferably coupled independently, via a pair of output paths, (not shown in Figure 7D) to the channel selector 42 of the apparatus 20 by means of a lead wire 740, comprising a pair of electrode connector ends. 740a and 740b and a pair of output path ends (not shown). As a result, this pair of electrodes independently receives one or more series of electrical pulses generated by one of the pulse generators of the apparatus 20. It is also contemplated that each electrode (instead of each pair of electrodes) of this electrode arrangement can receive independently one or more series of electrical pulses generated by a pulse generator. Also provided as shown in Figure 7D is a reinforcing tape cover 726 having a central slot 728 for securing the electrodes to the patient's skin.

Figure 7E shows another arrangement of the electrodes, in two pairs of electrodes arranged vertically. This arrangement is suitable for the treatment of most laryngeal and pharyngeal motor defects and is preferred for the treatment of many such defects. In this arrangement, the four electrodes are placed in a vertical ñla directly • contiguous to each other, but not overlapping, starting with the first highest electrode placing it on the patient's digastric muscles, covering the hyoid and clamping muscles of the larynx of the patient. patient, and ending with the fourth lowest electrode placed at the base of the patient's thyroid cartilage. As shown in Figure 7E, a first pair of electrodes 742 and 744 are placed vertically above the thyroid notch and generally along the central line of the patient's throat. A second pair of electrodes 746 and 748 are placed vertically below the notch and generally along the same centerline as the first pair. The first pair of electrodes of this series is preferably coupled · independently by a pair of output paths, (not shown in Figure 7D) with the channel selector 42 of the apparatus 20 by means of the lead wire 750, comprises a pair of connecting ends of electrodes 750a and 750b and a pair of output path ends (not shown). The second pair of electrodes of this series is preferably coupled independently by a pair of output paths, (not shown in Figure 7D) with the channel selector 42 of the apparatus 20 by means of a lead wire 752, consists of a pair of electrode connection ends 752a and 752b and a pair of output path ends (not shown). As a result, each of those pairs of electrodes independently receives one or more series of electrical pulses generated by one of the pulse generators of the apparatus 20, although it is also contemplated that each electrode (instead of each pair of electrodes) in that arrangement it can independently receive one or more series of electrical pulses generated by a pulse generator. The two upper electrodes 742 and 744 can be coupled with a first output channel of the channel selector 42, and the two lower electrodes 746 and 748 can be coupled with a second channel of the channel selector output. As shown in Figure 7D, a reinforcing tape cover 726 is provided to secure the electrodes to the patient's skin. In addition, the lead wires 750 and 752 can be mechanically connected together for ease of handling, and secured to the patient's shirt 754 using a preferred clip 756.

As shown in more detail in Figure 9, the clip 756 consists of a first part of the clip 758 and a second part of the clip 760. The first part of the clip has a built-in ring 762 that can rotate in pin 764 of the second part of the clip. Spring 766 is provided between the parts of the clip to keep the clip "closed", although it allows to open it easily. A groove of the lead wire 768 is provided in the part of the clip 760 to retain the lead wire so that it can be held to a point of the patient's clng and thus remain firmly in place.

The electrode arrangements of FIGS. 7A-7E are provided as an example of electrode placement and are not intended to limit the number and arrangement of the electrodes in use in the practice of the present invention. The electrodes are selectively placed at any suitable site within the pharyngeal region 200 of the patient as shown in Figures 3 and 4. The placement of the electrodes in the pharyngeal region of the patient is based on several factors, such as the magnitude and the type of oropharyngeal condition shown by the patient and, depending on the magnitude and type of oropharyngeal condition shown, in those sites within the pharyngeal region, which, when subjected to electrical stimuli, have the potential to cause swallowing with more strength and more completely. The patient is given an assessment of the ability to swallow to determine the extent and type of oropharyngeal condition. The critical elements in the evaluation are analyzed by means of a video fluoroscopy and a clinical evaluation to determine the presence of a nausea reflex, a dry swallow, and the ability to tolerate one's own secretions. The placement of the electrodes can be changed several times in an effort to obtain the strongest and most effective treatment.

A preferred method for neuromuscular electrical stimulation of the pharyngeal region according to the invention will now be described, using an apparatus similar to that shown in Figure 1, referring to Figure 2. In step 100 (Start Procedure), The procedure to treat oropharyngeal affections with neuromuscular electrical stimulation is initiated. Then, in step 102 (Application of the Electrodes to the Patient), the electrodes are applied to the pharyngeal region of the patient, as described above. In step 104 (Setting the Pulse Intensity), the desired intensity of the electrical pulses is set, preferably at the current level less than or equal to 25 mA. Likewise, in step 106 (Setting the Pulse Duration), the duration of each pulse is set, so that each pulse has a total pulse duration preferably within the range of about 550 to about 850 microseconds, with an interphase interval of about 50 to about 150 microseconds. Alternatively, the pulse duration can be set to a particular duration, as used in the VitalStim apparatus, for example, in a total pulse duration of about 700 microseconds, comprising a first phase of about 300 microseconds, an interface interval. of about 100 microseconds, and a second phase of about 300 microseconds. In step 106, the intervals between pulses can also be set, as well as the rate at which the intensity of the electrical pulses increases from an initial level to a final treatment level during a treatment session. Finally, in step 108 (Determination of Treatment Duration), a determination of the time of a treatment period (or the period during which the electrical pulses are applied in a treatment session) is made. In step 110 (Application of the Waveform), the patient is supplied with a series of electrical pulses, each one of which consists of a biphasic symmetric waveform with an interval between the two phases. Then, in step 112 (Is the Treatment Period over?), A determination is made as to whether a treatment session is finished according to the duration of the preselected treatment period. If the treatment period has ended, the next step is the method presented in step 114 (Are there Additional Treatment Periods?). This may be the case in which two or more sessions or treatment periods have been set, with a predetermined rest interval between the two periods. If in step 112, the determination is made that the treatment period has not ended, or if in step 114, additional treatment periods have been set, the sequence proceeds to step 116 ("Wait for the Fixed Duration") . After the stated duration of any rest interval has elapsed, the sequence returns to step 110, after which the electrical pulses are applied again to the patient. If in step 112, the determination is made that the treatment time has ended, and if no further treatment has been set, the final step in the method presented is step 118 ("End of Procedure").

The method and apparatus for neuromuscular electrical stimulation of the present invention provides an effective and non-invasive treatment for oro-pharyngeal conditions such as dysphagia. The method and apparatus for neuromuscular electrical stimulation is more effective for the treatment of oro-pharyngeal conditions than traditional treatment methods, such as rehabilitation by thermal stimulation or induced exercise. In addition, the method and apparatus of the present invention are effective for the treatment of the worst cases of dysphagia resulting from neurodegeneration and stroke.

Although this description contains many details, these will not be construed as limiting the scope of the invention but as merely illustrations of this provided with some of the preferred embodiments now, as well as the best mode contemplated by the inventor to carry out the invention. The invention, as described herein, is susceptible to various modifications and adaptations, and they are thought to fall within the equivalent meaning and scope in the items added below.

These points are:

Claims (4)

1. A method for the treatment of an oropharyngeal condition in a patient by neuromuscular stimulation, said method consists of the steps: (a) selective placement of a plurality of electrodes in electrical contact with the tissue of the pharyngeal region of the patient; (b) supplying a pulse generator to generate a series of electrical pulses, each of which comprises a biphasic symmetric waveform with an interval between the two phases; (c) clamping the plurality of electrodes to the pulse generator so that the series of electrical pulses can be delivered to the patient by means of the plurality of electrodes; (d) generation of a series of electrical pulses, each of which comprises a biphasic symmetric waveform with an interval between the two phases; (e) supplying said series of electrical pulses to the patient through the plurality of electrodes. ·

2. The method of point 1 that includes the generation of a series of electrical pulses at a current less than or equal to 25 mA.

3. The method of point 1 that includes the generation of a series of electrical pulses at a frequency of about 80 Hz.

4. The method of point 1 that includes the generation of a series of electrical pulses at a voltage less than or equal to 100 V. The method of point 1 that includes the generation of a series of electrical pulses at an energy less than or equal to 2500 mW. The method of point 1 that includes the following steps instead of step (a) of point 1: (a) supply of a first electrode and a second electrode, each of which consists of: (i) an instantaneous opening that has a first side and a second side, said second side has a connector to which a conductor cable can be fastened; (ü) a conductive film that is fastened to the first side of the instantaneous opening; (iii) a layer of adhesive and conductive gel that is attached to the conductive film and adapted to be attached to the skin of the patient; (a2) providing at least one reinforcing adhesive cover for securing the first and second electrodes to the patient's skin; (a3) placing the first electrode in the skin of the pharyngeal region of the patient with the adhesive gel layer in contact with the skin; (a4) placing the second electrode in the skin of the pharyngeal region of the patient with the adhesive gel layer in contact with the skin; (a5) attaching the electrodes to the skin of the pharyngeal region of the patient by applying at least one cover of a reinforcing plaster to the skin of the pharyngeal region of the patient on at least a portion of each of the electrodes. The method of point 1 that includes the generation of a series of electrical pulses, each one of which consists of a biphasic symmetric rectangular waveform that has a total pulse duration of between 550 and 850 microseconds, whose pulse duration it includes an inferred interval of between 50 and 150 microseconds. The method of point 1 that includes the generation of a series of electrical pulses, each of which consists of a biphasic symmetric rectangular waveform having a total pulse duration of about 700 microseconds, whose pulse duration includes a first phase of about 300 microseconds, an interface interval of about 100 microseconds and a second phase of about 300 microseconds .. A method for the treatment of a pharyngeal oropathy in a patient by neuromuscular electrical stimulation, said method consists of the steps: (a) selective placement of the first pair of electrodes in electrical contact with the tissue of the pharyngeal region of the patient; (b) selective positioning of the second pair of electrodes in electrical contact with the tissue of the pharyngeal region of the patient; (c) supply of an apparatus for generating a series of electrical pulses for the application of neuromuscular electrical stimulation to the patient by means of said. first pair of electrodes, and for the generation of. a series of electrical pulses for the application of neuromuscular electrical stimulation to the patient by means of said second pair of electrodes, said apparatus consists of: (i) a first pulse generator to generate a first series of electrical pulses, each of which it comprises a biphasic symmetric waveform with an interval between the two phases, to exit through the first channel; (ii) a first outlet for electrically connecting the first pair of electrodes to the first channel; (iii) a first intensity control circuit for regulating the first series of pulses for the output on the first channel so that the electric current does not exceed the first predetermined value; (iv) a first frequency controller for controlling the frequency at which the series of electrical pulses is generated by the first pulse generator for the output on the first channel so that such pulses are generated at a first predetermined frequency; (v) a first duration control circuit for controlling the duration of each electrical pulse generated by the first electrical pulse; (vi) a second pulse generator for generating a second series of electrical pulses, each of which comprises a biphasic symmetric waveform with a gap between the two phases, to exit through the second channel; (vii) a second outlet for electrically connecting the second pair of electrodes to the second channel; (viii) a second intensity control circuit for regulating the second series of pulses for the output by the second channel so that the electric current does not exceed the second predetermined value; (ix) a second frequency controller for controlling the frequency at which the series of electrical pulses is generated by the second pulse generator for output by the second channel so that such pulses are generated at a second predetermined frequency; (x) a second duration control circuit for controlling the duration of each electrical pulse generated by the second electrical pulse; (d) connecting the first pair of electrodes to the first outlet path; (e) connecting the second pair of electrodes to the second outlet path; (f) generation of the first series of electrical pulses, each of which consists of a biphasic symmetric waveform with a gap between the two phases, to exit through the first channel; (g) generation of the second series of electrical pulses, each of which consists of a biphasic symmetric waveform with a gap between the two phases, to exit through the second channel; (h) supplying a first series of electrical pulses for the first channel for the first pair of electrodes; (i) supply of a second series of electrical pulses through the second channel for the second pair of electrodes. An apparatus for the generation of a series of electrical pulses for the application of neuromuscular electrical stimulation to a patient through a plurality of electrodes for the treatment of oropharyngeal affections, said apparatus consists of a pulse generator that generates a series of electrical pulses , each of these pulses comprises a biphasic symmetrical waveform with an interval between the two phases, said pulse generator further comprising: (a) an intensity control circuit for regulating the series of electric pulses so that the intensity of the electrical pulses does not exceed a predetermined value; (b) a frequency controller to control that the frequency at which the series of electrical pulses is generated so that such pulses are generated at a predetermined frequency; (c) a duration control circuit for controlling the duration of each electrical pulse. The apparatus of item 10 in which the intensity control circuit allows the predetermined value to be set selectively for the intensity of the series of electrical pulses at an intensity level within the range of 0.5-25 mA. The apparatus of point 10 in which the frequency controller controls the frequency at which the electrical pulses are generated so that such pulses are generated at a frequency of about 80 Hz. The apparatus of item 10 including: (a) a first electrode and a second electrode, each of which comprises: (i) an instantaneous opening having a first side and a second side, said second side having a connector at that a conductor cable can be fastened; (ii) a conductive film that is fastened to the first side of the instantaneous opening; (iii) a layer of adhesive and conductive gel that is attached to the conductive film and adapted to be attached to the skin of the patient; (b) at least one reinforcing adhesive cover for securing the first and second electrodes to the patient's skin. The apparatus of item 10 consisting of a pulse generator that generates a series of electrical pulses, each of which consists of a two-phase symmetric rectangular waveform, said pulse generator has a duration control circuit for controlling the pulse. duration of each of such electrical pulses for such a pulse to have a total pulse duration of between about 550 and 850 microseconds, whose pulse duration includes an interphase interval of between about 50 and 150 microseconds. The apparatus of item 14 wherein the duration control circuit controls the duration of each such electrical pulse so that each such electrical pulse has a total duration of about 700 microseconds, whose pulse duration includes a first phase of about 300 microseconds, an interface interval of about 100 microseconds and a second phase of about 300 microseconds. An apparatus for generating a series of electrical pulses for the application of neuromuscular electrical stimulation to a patient for the treatment of oropharyngeal conditions, said apparatus consists of: (a) a first pair of electrodes; (b) a second pair of electrodes; (c) a first pulse generator for generating a first series of electrical pulses, each of which comprises a biphasic symmetric waveform with a gap between the two phases, to exit through a first channel; (d) a first current control circuit for regulating the first series of pulses for the output through the first channel so that the electric current does not exceed the first predetermined value; (e) a first frequency controller for controlling the frequency at which the first series of electrical pulses is generated by the first pulse generator for output on the first channel so that such pulses are generated at a first predetermined frequency; (f) a first duration control circuit for controlling the duration of each electrical pulse generated by the first pulse generator; (g) a second pulse generator for generating a second series of electrical pulses, each of which comprises a biphasic symmetric waveform with a gap between the two phases, to exit through a second channel; (h) a second intensity control circuit for regulating the second series of electrical pulses for output by the second channel so that the electric current does not exceed the second predetermined value; (i) a second current control circuit for regulating the second series of electrical pulses for output by the second channel so that the electrical current does not exceed the second predetermined value; (j) a second frequency controller - for controlling the frequency at which the second series of electrical pulses is generated by the pulse generator for output by the second channel so that such pulses are generated at a predetermined frequency; (k) ·. a second duration control circuit for controlling the duration of each electrical pulse generated by the second pulse generator; The apparatus of item 16 wherein: (a) the predetermined value for the electric current of the first series of electrical pulses can be selectively set at a current level within the range of 0.5-25 mA; and (b) the predetermined value for the electrical current of the second series of electrical pulses can be selectively set at a current level within the range of 0.5-25 mA The apparatus of point 16 in which the frequency controller for each pulse generator controls the frequency at which the series of electrical pulses is generated to exit through each channel so that such pulses are generated at a frequency of about 80 Hz . The apparatus of item 16 wherein the duration control circuit for each pulse generator controls the duration of each such electrical pulse so that such a pulse has a total pulse duration of between about 550 and 850 microseconds, the duration of which Pulse includes an interphase interval of between 50 and 150 microseconds The apparatus of item 16 which includes: (a) a first pair of electrodes, each of which comprises: (i) an instantaneous opening having a first side and a second side, said second side having a connector which is Can hold a wire rope; (ii) a conductive film that is fastened to the first side of the instantaneous opening; (ii) a layer of adhesive and conductive gel that is attached to the conductive film and adapted to be attached to the patient's skin; (b) a second pair of electrodes, each of which comprises: (i) an instantaneous opening having a first side and a second side, said second side having a connector to which a lead wire can be fastened; (ii) a conductive film that is fastened to the first side of the instantaneous opening; (iii) a layer of adhesive and conductive gel that is attached to the conductive film and adapted to be attached to the skin of the patient;