MXPA98003209A - Neuromuscular stimulator faringeo, electr - Google Patents

Abstract

This invention is directed to a non-invasive, simple method and a device for the treatment of dysphagia and thus artificially provoke swallowing, by means of electrical stimuli. In the present invention, a plurality of electrodes adapted to be selectively placed in electrical contact with the tissue of a pharyngeal region of a patient, and a generator for generating a series of electrical pulses, generally having a frequency set at 80 hertz, a pulse width modulator, to generate each pulse of the series of electrical pulses, to a generally fixed duration of 300 microseconds, and a governor to regulate the electric pulses in such a way that at least one current does not exceed 4.4 milliamperes RMS or the power does not exceed 9.6 MW RMS. The electrical pulses selectively stimulate the localized muscles near the electrodes selectively placed to initiate swallowing

Description

STIMULATOR NEUROMUSCÜLAR FARÍNGEO, ELÉCTRICO Background of the Invention This invention relates to a method and a device for effectively treating dysphagia. In particular, the present invention relates to a method and a device for treating dysphagia by providing electrical stimulation to the pharyngeal region of an associated animal. Dysphagia is the inability to swallow or difficulty swallowing and can be caused by stroke, neurodegenerative diseases or respiratory disorders. The swallowing is a complicated action which often starts involuntarily, but always takes place reflexively, where the food is displaced from the mouth through the pharynx and the esophagus and up to the stomach. The act of swallowing occurs in three stages and requires the integrated action of the respiratory center and the motor functions of multiple cranial nerves and the coordination of the autonomic system, within the esophagus. In the first stage, the food is located 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 towards REF: 27330 the isthmus in the jaws of the pharynx. In the second stage, the food passes through the pharynx. This involves, to the constriction of the walls of the pharynx, with the epiglottis leaning backwards, the larynx and the trachea with a forward movement. Thus, food is prevented from entering the nasal cavity, by raising the soft palate and entering the larynx, by closing the glottis and the backward tilt of the epiglottis. During this stage, respiratory movements are inhibited by reflex. In the third stage, the food moves down through the esophagus and into the stomach.

This movement is performed at the same time as in the second step, by peristaltic contractions and gravity.

Although the main function of swallowing is to propulsion the food from the mouth to the stomach, the swallowing also works as a protective reflex of the respiratory tract, since it removes the trapped particles in the nasopharynx and the oropharynx, returning the reflux materials, from the stomach to the pharynx, or returning the displaced particles from the upper respiratory tract, to the pharynx. With this, the absence of an adequate swallowing reflex greatly increases the chance of pulmonary aspiration. In the past, patients suffering from dysphagia underwent dietary changes or thermal stimulation treatments, to regain the reflexes of an adequate swallowing. Thermal stimulation involves inserting a mirror or probe into ice or an icy substance. The tonsilar fossa is stimulated with the mirror or probe, and the patient closes his mouth and tries to swallow. While these traditional methods are usually effective for the treatment of dysphagia, these methods often require the patient to support weeks or months of therapy. Electrical stimulation has been used frequently, as a method to relieve pain, stimulating the nerves and also, as a means to diagnose disorders in the spine or peripheral nervous system. Electrical stimulation has also been used to facilitate the rehabilitation and reeducation of muscles and along with other physical therapy treatments. In the past, electrical stimulation has not been recommended for use in the neck or thoracic region, since severe spasms may occur in the laryngeal and pharyngeal muscles, resulting in airway closure or difficulty breathing. In addition, the introduction of electrical current in the heart can cause cardiac arrhythmia. Electrical stimulation has been used to stimulate the recurrent laryngeal nerve, to stimulate the laryngeal muscles, to control the opening of the vocal cords, to attend the paralysis of vocal cords, to assist in the estimation of the functioning of the vocal cords, to help with intubation and other related uses. In spite of this and up to now, the electrical stimulation has not been used in the treatment of dysphagia, to provoke the reflex of the swallowing, which involves the integrated action of the respiratory center and the motor functions of the multiple cranial nerves and the coordination of the autonomous system within the esophagus. It is desirable to have a non-invasive, simple method and a device for the treatment of dysphagia and thus provoke artificial swallowing.

Brief Compendium of the Invention In accordance with the present invention, a non-invasive, simple method and a device is provided for the treatment of dysphagia and artificially causing swallowing, where electrical stimuli are provided to the pharyngeal region of a patient, to stimulate the muscles located in the pharyngeal region, with the aim of causing swallowing. According to the present invention, a simple non-invasive method is provided for the treatment of dysphagia and artificially provoking the swallowing, by means of electrical stimuli, the method comprising, selectively placing electrodes in electrical contact with the tissue of the pharyngeal region of a patient and generating a series of electrical pulses in electrical contact, with each of the plurality of electrodes, wherein the electrodes provide a series of electrical pulses to selectively stimulate the muscles located proximally to the selectively placed electrodes, So, start the swallowing. According to the present invention, there is provided a non-invasive, simple method for the treatment of dysphagia and artificially causing swallowing, the device comprising, a plurality of electrodes adapted to be selectively placed in electrical contact with the tissue of a pharyngeal region of a patient, and a generator to generate a series of electrical pulses, having a generally a frequency set at 80 hertz, a pulse width modulator, to generate each pulse of the series of electrical pulses, to generally a duration fixed to 300 microseconds, and a governor to regulate the electrical pulses in such a way that at least one current does not exceed 4.4 milliamperes RMS or the power does not exceed 9.6 MW RMS. This and other aspects of the invention will be apparent to those skilled in the art, as they read and understand the specifications that follow.

Brief Description of the Drawings The invention may take physical form in certain parts and arrangements of parts, a preferred embodiment and a method, which will be described in detail in this specification and illustrated in the accompanying drawings, which form a part in themselves, and in which: FIG. . 1 is a simplified fragmentary illustration of an electrical pharyngeal neuromuscular stimulator, for use in causing swallowing, according to the present invention; FIG. 2 is a flow diagram of a method for electrical pharyngeal neuromuscular stimulation, to cause swallowing, according to the present invention; FIG. 3 is a view of a portion of a pharyngeal region of a patient, illustrating the placement of the electrodes according to the present invention; FIG. 4 is a view of a portion, of a pharyngeal region of a patient, illustrating the placement of the electrodes according to the present invention; and FIG. 5 is a graph illustrating the effectiveness of the method for electrical pharyngeal neuromuscular stimulation and the device, according to the present invention.

Detailed Description of the Preferred Modalities This invention is directed to a non-invasive, simple method and a device for electrical pharyngeal neuromuscular stimulation, to cause swallowing, where it provides electrical stimulation to the pharyngeal region of a patient, to stimulate the muscles located in the pharyngeal region, with the aim of causing the swallowing. Referring now to the drawings, wherein the objectives of illustrating the preferred embodiment of the invention are only to show, not for purposes of limiting thereto, the pharyngeal electrical neuromuscular stimulation device 10, as shown in FIG. . 1, is comprised of a plurality of electrodes 12, adapted to be selectively placed in electrical contact with the tissue of a pharyngeal region of a patient, and a generator 20, to generate a series of electrical pulses, in electrical contact with each of the plurality of electrodes. The device 10 is preferably comprised of two electrodes. The electrodes 22 are preferably made of a metal or other physiologically acceptable conductive material. In general, the electrodes 22 are of any suitable conventional and convenient form, which should be suitable for physiological applications. The charging cables 14 are made of any physiologically acceptable conducting metal, preferably an isolated aluminum cable. The subject waveforms are suitably made by a selectable control of a pulse generator 20, working in connection with an amplifier 18. The generator 20 is comprised of a pulse range modulator or a frequency controller 22, to generate each of the electric pulses, having a frequency usually set at 80 hertz. The generator 20 is also comprised of a pulse width modulator, suitably performed, with an on / off duration control 24 to generate each pulse of the series of electrical pulses to generally a duration of 300 milliseconds. The generator further comprises a governor 26 for regulating the electrical pulses in such a way that the electric current does not exceed 4.4 milliamperes RMS, the power does not exceed 9.6 MW RMS, or either. The applied current will vary depending on the physical condition and the tolerance of the patient, but the applied current should be sufficient to produce the desired response and provoke the swallowing reflex. The intensity of the current is increased in small increments, until the limits in the level of tolerance and comfort are reached by the patient. Despite this, the current that is applied, should not be very intense and therefore, result in laryngeal spasms or cardiac arrhythmia in the patient.

Another input for the pulse generator 20 is formed by the amplitude control module 28. The amplitude control module 28 allows the selective control of an amplitude of pulses generated from the pulse generator 20. The channel selector 30, suitably forming another input to the amplifier 18, to allow the concurrent activation of groups of electrodes 12, the state of the channel selector 30 is effectively indicated by the channel selector indicator 32. In one embodiment of the present invention, the generator continuously generates electrical pulses for a predetermined period of time. Preferably, the electrical pulses are continuously generated and sent to the electrodes, until a complete swallowing is obtained or the level of tolerance is reached by the patient. The additional treatments in which the generator continuously generates electrical pulses, are adequately performed in the patient, as necessary. In another embodiment of the present invention, the generator selectively generates electric pulse cycles. The generator further comprises a treatment time controller which is also performed in conjunction with the real-time information control 26, which is provided by a timer 40. The timer 40, control 26 and pulse generator 16 also serve to provide the functions of controller outside treatment time, controller outside treatment ramp and controller in treatment ramp. The treatment time controller selectively controls the duration of time in which the generator selectively generates cycles of electrical pulses. The treatment time is any suitable period, such as 15, 30 or 60 minutes. Like all measures, the particular values are highly specific, depending on the patient and the application. Thus, a suitable duration is determined for the electrical pulses in each cycle. Preferably, the duration of the electrical pulses in each cycle are from a range of 0.5 to about 30 seconds. A selection is made for an amount of time between each cycle. Preferably, the amount of time between the cycles will be from 0.1 to about 60 seconds. A selection is also made for the amount of time required to decrease from the maximum intensity to the zero intensity at the end of each cycle. Preferably, the amount of time required to decrease from maximum intensity to zero intensity is between 0.1 and about 60 seconds. Preferably, the amount of time required to decrease from the maximum intensity to zero intensity is between 0.1 seconds to about 6.0 seconds. A commercially available and appropriate device, which provides the functions described above, is found in the Staodyn EMS + 2 System, manufactured by Staodyn, Inc. and described in the associated instructional manual, which is incorporated for reference.

FIG. 2 provides a flow diagram of the method for electrical arygeal neuromuscular stimulation, to cause swallowing, according to the present invention. Going to block 100, the procedure for the treatment of dysphagia with electrical stimulation is initiated. Then, in block 102, these electrodes are applied to the pharyngeal region of the patient. The details of the placement and selection of the electrodes have been discovered elsewhere in the subject application. Leaving us later to block 104, a pulse frequency is selected according to the parameters discovered above. Similarly, in block 102, a pulse duration is selected. Finally, in block 108, a determination of the duration of the treatment is made, as well as the number of treatment periods, which have to be applied.

Following block 110, a present waveform associated with the previously selected parameters is applied to the pharyngeal region of the patient. After, in block 112, a determination is made, if the treatment period has been completed in accordance with the preselected standards. A positive determination results in progress to decision block 114 and a negative determination results in progress to decision block 116. In block 116, a duration selection is applied, such as a waiting period, in which it is returned in progress to block 110, as described above. In block 114, a determination is made to see if additional periods of treatment are needed. A positive determination results in returning to block 11. A negative determination signals the termination of the treatment procedure and in progress to the termination block 118. The electrodes are selectively located at any suitable site within the pharyngeal region 200 of the patient, as it is shown in FIGS. 3 and 4. The placement of the electrodes in the pharyngeal region of the patient is based on several factors, such as the extent and type of dysphagia exhibited by the patient and, given the extent and type of dysphagia exhibited, these locations within of the pharyngeal region, when subjected to electrical stimuli, they are capable of producing the most complete deglutition. An evaluation is made for the ability to swallow in the patient, to determine the extent and type of dysphagia. The critical elements in the evaluation are determining the presence of a gagging reflex, a dry swallowing and the ability to tolerate the secretions of oneself. The placement of the electrodes can be changed several times in order to obtain the strongest and most effective treatment possible. As shown in FIGS. 3 and 4, in one embodiment of the invention, a pair of electrodes 202, are located on the skin of the pharyngeal region 200 at a position approximated to the minor horn 204 of the hyoid bone 206 on both sides of the pharyngeal region 200 and just below the body of the hyoid bone 206. The electrodes overlap the muscles at the base of the mouth. In a second embodiment of the present invention, a pair of electrodes 208 are located in the skin of the pharyngeal region 200 on one side of the center line of the pharyngeal region 200. An electrode 208a is placed on the thyroid membrane 210 a approximately the level of the minor tube 204, near the hyoid bone 206. This electrode 208a overlies the sternothyroid muscle 214. The other electrode 208b is placed in the cricoid cartilage 216, on one side of the pharyngeal region 200 centreline. This electrode superimposes the sternohyoid muscle 218 and the sternothyroid muscle 212, on one side of the central line of the pharyngeal region. In a third embodiment of the present invention, a pair of electrodes 220 are placed on the skin of the pharyngeal region 200 on the thyroid membrane 210 on either side of the center line of the pharyngeal region 200. These electrodes are superimposed on the thyroid muscle 214 and in the sternohyoid muscle 218. In a fourth embodiment of the present invention, a pair of electrodes 222 is placed on the skin of the pharyngeal region 200 on either side of the midline of the pharyngeal region 200, near the middle between the thyroid cleft 224 and the cricoid cartilage 216. These electrodes superimpose the sternohyoid muscle 218 and the transmission zone between the sternothyroid muscle 212 and the thyroid muscle 214 on either side of the central line of the pharyngeal region 200. In a fifth embodiment of the present invention, a pair of electrodes 226, are located in the skin of the pharyngeal region 200, in any of the sides of the midline of the pharyngeal region 200. An electrode 226a is located just to one side of the minor tube 204 and the hyoid bone 206, close to the middle between the hyoid bone 206 and the lower edge of the mandible (not shown ). This electrode is superimposed on the mylohyoid muscle 228 and the digastric muscle 230. The other electrode 226b, is placed near the upper end of the thyroid membrane 210 and next to the hyoid bone 206 or on the hyoid bone 206, approximately at the level of the minor tube 204 of the hyoid bone 206. This electrode overlaps the sternothyroid muscle 212 and the thyroid muscle 214. In a sixth embodiment of the present invention, a pair of electrodes 232 are placed on the skin of the pharyngeal region 200 on one side of the centerline of the pharyngeal region 200. An electrode 232a is located on the centerline of the pharyngeal region 200a. the pharyngeal region, near the chin (not shown). The other electrode 232b is located laterally to the other electrode. These electrodes superimpose the mylohyoid muscle 228 and the digastric muscle 230 on the central line and on either side of the central line of the pharyngeal region 200.

EXAMPLE 1 Ninety-four patients suffering from dysphagia as a result of stroke or neurodegeneration were studied. The swallowing ability of each patient was evaluated to determine the extent and type of dysphagia exhibited by the patient. The ability to swallow of each patient was assigned to a number, which corresponded to a corresponding swallowing state, where the swallowing states are listed below; the state of zero deglutition is the inability to have a pharyngeal contraction; the state of swallowing one is the inability to swallow the secretions of oneself; the state of swallowing two is the ability to swallow pasta, porridge or similar substances; the state of swallowing three is the ability to swallow honey or similar substances; the state of swallowing four is the ability to swallow nectar or similar substances; the five swallowing state is the ability to swallow thin liquids; and the state of swallowing six is the ability to swallow water. All patients were determined to have a deglutition status of either, zero or one, indicating that the patient did not have a pharyngeal contraction, no gagging reflex or the ability to withstand secretions. The patients were then, subject to a series of treatment sessions. The patients were divided into two treatment groups: electrical stimulation and thermal stimulation. Sixty-three patients were subjected to a series of electrical stimulation treatment sessions. Preferably, the patients were subjected to at least seven sessions of electrical stimulation treatment. At each treatment session, the electrodes were selectively placed on the skin of the patient's pharyngeal region. The location of the electrodes was determined by the extent and type of dysphagia exhibited by the patient and, given the extent and type of dysphagia exhibited, these locations within the pharyngeal region, when subjected to electrical stimuli, were able to produce the most complete and strong deglutition. The placement of the electrodes was adjusted until the patient got the most complete contraction to which he was capable. Once the correct electrode location was determined, the intensity of current was increased by small increments, until the patient reached the limits of the tolerance and comfort level. The optimal intensity was obtained when the patient felt a stretch or a sting in the area of stimulation. The patient was then subjected to continuous electrical stimulation where the electrical pulses were continuously generated and sent to the electrodes where a complete deglutition was achieved or the level of tolerance was reached by the patient. This step was repeated five to twenty times in each treatment session, where the patient was subjected to continuous electrical stimulation. If the electrical stimulation was successful in causing a complete contraction, the oral cavity was cleaned and the patient attempted to swallow dry. In those patients in whom no pharyngeal contraction was exhibited, one or more treatment sessions were required, before dry swallowing occurred. Once adequate dry swallowing was achieved, oral substance was provided to assist with treatment. The consistency of the oral substance is determined by the strength of the contraction obtained by the patient. If the patient was able to swallow their own saliva, a cotton ball was soaked with water or juice and applied to the oral cavity. The patient tried to swallow the water or the juice, at the time of being subjected to continuous electrical stimulation. Once the patient got strong and audible contractions, the patient was challenged with porridge, thick liquids or iced scraping. The patient tried to swallow these substances, while he was being subjected to continuous electrical stimulation. Once three or five strong and audible contractions were achieved with electrical stimulation assistance, the patient tried to swallow these substances without the assistance of electrical stimulation. The treatment sessions were continued until the patient's improvement was noticeable. Thirty-one patients were subjected to a series of thermal stimulation treatment sessions. Preferably, the patients were subjected to at least seven sessions of thermal stimulation treatment. In each treatment session, a mirror or probe was immersed in ice or an icy substance. The tonsilar fossa was stimulated with the mirror or probe, the patient then closed his mouth and tried to swallow dry. If the thermal stimulation was successful, oral substance was provided to assist the treatment. The consistency of the oral substance is determined by the strength of the contraction obtained by the patient. If the patient was able to swallow their own saliva, a cotton ball was soaked with water or juice and applied to the oral cavity. The patient tried to swallow the water or the juice, while being subjected to continuous thermal stimulation. Once the patient got strong and audible contractions, the patient was challenged with porridge, thick fluids or ice cream. The patient tried to swallow these substances, while he was being subjected to continuous thermal stimulation. Once three or five strong and audible contractions were obtained with thermal stimulation assistance, the patient tried to swallow these substances without the assistance of thermal stimulation. The treatment sessions were continued until the patient's improvement was noticeable. The effectiveness of electric stimulation treatments and thermal stimulation treatments are shown in FIG. 5, which is an illustrated graph the true swallowing state, achieved after the electric stimulation treatments and the thermal stimulation treatments. After seven sessions of treatment, the swallowing state obtained from the patient treated with electrical stimulation was of a five-stage swallowing state or the ability to swallow thin liquids. After seven sessions of treatment, the state of swallowing obtained from the patient treated with thermal stimulation was only a state of swallowing one or the ability to swallow the secretions of oneself.

The method and device for electrical pharyngeal neuromuscular stimulation of the present invention provides a non-invasive, simple treatment for dysphagia. The method and device for electrical pharyngeal neuromuscular stimulation is more effective for the treatment of dysphagia than other traditional treatment methods, such as thermal stimulation. In addition, the method and device of the present invention is effective in the treatment of but a case of dysphagia, resulting from a neurodegeneration or a stroke.

While several modalities of a method and device to artificially provoke the swallowing reflex have been discovered, it should be understood that modifications and adaptations of these will occur to persons who are experts in the art. Other features and aspects of this invention will be appreciated by those experts in the art, when reading and understanding this discovery. Said features, aspects and expected variations and modifications of the reported results and examples are clearly within the scope of the invention wherein the invention is limited only by the field of the following claims. It is noted that, with regard to this date, the best method known by the requested, to carry out the present invention, is that which is clear from the present, discovering the invention. Having described the invention as above, the content of the following is claimed as property.

Claims (1)

1. CLAIMS An electrical pharyngeal neuromuscular stimulator, characterized in that it comprises: a) a plurality of electrodes adapted to be selectively placed in electrical contact with the tissue of the pharyngeal region of an associated animal; and b) a generator, fixed to each of the plurality of electrodes, to generate a series of electrical pulses, the generator including: i) a pulse rate modulator for generating each of the electrical pulses, having a predetermined frequency, ii) a pulse width modulator for generating each of the electrical pulses, having a predetermined duration, iii) a circuit for regulating the voltage of the series of the electrical pulses, to prevent the voltage from exceeding the predetermined voltage limit, and iv) a circuit to regulate the current of the series of electrical pulses, to prevent the voltage from exceeding the predetermined current limit. The pharyngeal neuromuscular stimulator, electric, according to claim 1, characterized in that in this, the generator also comprises means for temporarily varying the network magnitude of the value of the electric current, applied to the associated electrode means, through the series of electrical pulses. The electrical pharyngeal neuromuscular stimulator, according to claim 2, characterized in that in this, the means for temporarily varying the network magnitude of the value of the applied electric current, is a ramp generator to increase the magnitude of the current value applied, for a predetermined period of time. The electrical pharyngeal neuromuscular stimulator, according to claim 2, characterized in that in this, the means for temporarily varying the network magnitude of the applied electric current value, is a ramp generator to decrease the magnitude of the value of the applied current, for a predetermined period of time. The electrical pharyngeal neuromuscular stimulator, according to claim 1, is characterized in that in this, the generator also comprises the cycle means for generating the series of electric pulses with a plurality of moderate cycles. The electrical pharyngeal neuromuscular stimulator according to claim 1, characterized in that in it, the cycle means include: a) means for suspending the generation of electrical pulses for a predetermined period of time; and b) means for generating the electrical pulses for a predetermined period of time. A pharyngeal, electrical neuromuscular stimulation method for artificially causing swallowing, characterized in that the method comprises the steps of: a) selectively placing a plurality of electrodes in electrical contact with the tissue of the pharyngeal region of an associated animal; and b) generate a series of electrical pulses, using a generator that includes: i) a pulse range modulator to generate each of the electrical pulses, having a predetermined frequency, ii) a pulse width modulator to generate each of the electric pulses, having a predetermined duration, iii) a circuit to regulate the voltage of the series of the electric pulses, to avoid that the voltage exceeds the predetermined voltage limit, and iv) a circuit to regulate the current of the series of the electrical pulses, to prevent the voltage from exceeding the predetermined current limit.