Method and apparatus for treating oropharyngeal respiratory and oral motor neuromuscular disorders with electrical stimulation

A simple, non-invasive device and method for treating oropharyngeal, respiratory, and oral motor neuromuscular disorders provides electrical stimulation to various regions of a patient. The method and device offer an effective and non-invasive treatment for these disorders. The device is an electrical neuromuscular stimulator that includes a pulse generator for generating a series of electrical pulses and a processor coupled to the pulse generator for controlling its operation. An electrode array of uni-directional or bi-directional electrodes is coupled to the pulse generator and provides electrical stimulation to the appropriate neck, chest, or facial region of the patient. Using bi-directional snap electrodes, for example, the electrode array may also generate electrical feedback signals in response to the neuromuscular stimulation of the patient. The electrical feedback signals are provided to the processor, which generates and stores test data and may modify the operation of the device in response to the electrical feedback signals.

FIELD OF THE INVENTION
 This invention relates to a method and apparatus for effectively treating
 oropharyngeal, respiratory, and oral motor neuromuscular disorders. In
 particular, the present invention relates to a method and apparatus for
 treating oropharyngeal, respiratory and oral motor neuromuscular disorders
 by providing electrical stimulation to specific muscle regions of a
 patient using one or more snap electrodes.
 BACKGROUND OF THE INVENTION
 Asymptomatic and symptomatic oropharyngeal disorders can lead to an
 inability to swallow or difficulty in swallowing. These disorders may be
 caused, for example, by stroke, neurodegenerative diseases, brain tumors
 or respiratory disorders.
 Swallowing is a complicated action whereby food is moved from the mouth
 through the pharynx and esophagus to the stomach. The act of swallowing
 may be initiated voluntarily or reflexively but is always completed
 reflexively.
 The act of swallowing occurs in three stages and requires the integrated
 action of the respiratory center and motor functions of multiple cranial
 nerves, and the coordination of the autonomic system within the esophagus.
 In the first stage, food or some other substance is placed on the surface
 of the tongue. The tip of the tongue is placed against the hard palate.
 Elevation of the larynx and backward movement of the tongue forces the
 food through the isthmus of the fauces in the pharynx. In the second
 stage, the food passes through the pharynx. This involves constriction of
 the walls of the pharynx, backward bending of the epiglottis, and an
 upward and forward movement of the larynx and trachea. Food is kept from
 entering the nasal cavity by elevation of the soft palate and from
 entering the larynx by closure of the glottis and backward inclination of
 the epiglottis. During this stage, respiratory movements are inhibited by
 reflex. In the third stage, food moves down the esophagus and into the
 stomach. This movement is accomplished by momentum from the second stage,
 peristaltic contractions, and gravity.
 Although the main function of swallowing is the propulsion of food from the
 mouth into the stomach, swallowing also serves as a protective reflex for
 the upper respiratory tract by removing particles trapped in the
 nasopharynx and oropharynx, returning materials refluxed from the stomach
 into the pharynx, or removing particles propelled from the upper
 respiratory tract into the pharynx. Therefore, the absence of adequate
 swallowing reflex greatly increases the chance of pulmonary aspiration.
 In the past, patients suffering from oropharyngeal disorders have undergone
 dietary changes or thermal stimulation treatment to regain adequate
 swallowing reflexes. Thermal stimulation involves immersing a mirror or
 probe in ice or another cold substance. The tonsillar fossa is stimulated
 with the mirror or probe, and the patient closes his mouth and attempts to
 swallow. While these traditional methods are usually effective for
 treating oropharyngeal disorders, in some patients these methods require
 that the patient endure weeks or months of therapy. It is also difficult
 to distinguish these patients who require more extensive treatments from
 patients who recover spontaneously. Thus, it is desirable to have a
 simple, non-invasive method and device for treating oropharyngeal
 disorders and artificially promoting swallowing which is effective within
 a relatively short treatment period.
 Electrical stimulation has been used as a method for alleviating pain and
 stimulating nerves, as well as a means for treating disorders of the
 spinal cord or peripheral nervous system. Electrical stimulation has
 further been used to facilitate muscle reeducation and with other physical
 therapy treatments. In the past, electrical stimulation was not
 recommended for use in the neck because of the theoretical concerns that
 the patient would develop spasms of the laryngeal muscles, resulting in
 closure of the airway or difficulty in breathing. Further, the
 introduction of electrical current into the neck near the carotid body may
 cause cardiac arrhythmia.
 More recently, 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 overcome vocal cord paralysis, to assist
 with the assessment of vocal cord function, to aid with intubation, and
 other related uses. There have been no adverse reactions to such treatment
 techniques. However, electrical stimulation has not been used in the
 treatment of oropharyngeal disorders to promote the swallowing reflex,
 which involves the integrated action of the respiratory center and motor
 functions of multiple cranial nerves.
 The oral motor skills needed to effectively speak, chew and swallow include
 the ability to open and close the mouth, the ability to elevate the
 tongue, the ability to laterals the tongue, and the ability to purse the
 lips. Deficiencies in one or more of these oral motor skills as sometimes
 occurs in children and stroke victims, for example, can delay or cause a
 complete inability of a patient to achieve safe oral intake.
 Known treatment techniques for oral motor skills deficiencies typically
 require lengthy treatment periods to achieve the skills necessary to speak
 and swallow. Thus, there is a need for a method of treatment that enables
 development of these skills with relatively fewer treatments performed
 within a shorter period of time.
 Chronic respiratory disorders, including asthma, bronchitis, asthma-like
 symptoms, chronic obstructive pulmonary disease, and actelectasis are
 common and often debilitating disorders. Individuals suffering from one or
 more of these disorders may incur the expense of high-cost medications and
 may be severely limited in terms of the physical activities they are able
 to undertake. These individuals may also be placed on ventilators because
 they are unable to breathe deeply enough without the aid of a ventilator.
 Such ventilator dependence substantially increases the cost to the patient
 and severely restricts the patient's mobility. Thus, there is a need for a
 simple, inexpensive treatment for chronic respiratory disorders that
 reduces the coughing and inflammation associated with such disorders, for
 example, to allow the patient to be extubated from a ventilator and/or to
 reduce or eliminate the medications needed by the patient, thereby
 substantially reducing the costs of the treatment and improving the
 quality of life of the patient.
 SUMMARY OF THE INVENTION
 The present invention provides a simple, non-invasive method and device for
 treating oropharyngeal disorders and artificially promoting swallowing.
 The present invention further provides a simple, non-invasive method and
 device for treating respiratory disorders such as asthma, bronchitis, and
 chronic obstructive pulmonary disease to provide improved respiratory
 capacity of a patient. The present invention also provides a simple,
 non-invasive method and device for treating oral motor neuromuscular
 damage and disorders to provide improved control and usage of oral motor
 muscles.
 According to one embodiment of the present invention, a method and device
 provide electrical stimulus to the pharyngeal region of a patient (a human
 or other animal) to stimulate muscles and nerves located in the pharyngeal
 region in order to promote swallowing.
 The method and device for electrical pharyngeal neuromuscular stimulation
 according to the present invention are more effective for treating
 oropharyngeal disorders than traditional treatment methods, such as
 thermal stimulation. Further, the method and device of the present
 invention are effective for treating worst-case dysphagia resulting from
 neurodegeneration and strokes.
 According to another embodiment of the present invention, a method and
 device provide electrical stimulus to the intercostal muscle regions
 between the ribs of a patient to enable improved respiratory functions of
 the patient, treating respiratory disorders such as asthma, bronchitis or
 chronic obstructive pulmonary disease, and further treating ventilator
 dependence (also known as life support) conditions of patients with no
 ability to breathe independently. By providing electrical stimulation to
 these muscles, deeper self-motivated inhalations and exhalations may be
 achieved by the patient. The method and device according to the present
 invention may substantially reduce coughing and inflammation suffered by
 the patient, substantially increase the air intake and outflow of the
 patient, and may allow a patient on a ventilator to achieve sufficiently
 deep aspirations to enable extubation of the patient from the ventilator.
 None of the known treatments for respiratory disorders is capable of safely
 achieving the results achieved by the method and device according to the
 present invention. The method and device according to the present
 invention may also eliminate the long-term costs and potential side
 effects from inhalers and other medications, as well as avoid the need for
 high-cost, long-term ventilator care.
 According to another embodiment of the present invention, the method and
 device provide electrical stimulation to various oral motor muscles and
 nerves to enable treatment of muscle and nerve damage and disorders of
 these muscles. Use of the method and device according to the present
 invention may result in substantial improvement of the physical skills
 needed to speak, chew, and swallow effectively after only a few
 treatments, for example two to three treatments, thereby allowing
 expedited recovery of the patient. The present invention facilitates the
 retraining and use of the oral motor muscles to enable the patient to
 speak, chew and swallow, thereby allowing safe intake of food and liquids
 and regular self-motivated breathing. Moreover, the method and device
 according to the present invention may be used to apply electrical
 stimulation to oral motor muscles to create a more normal facial
 appearance of a patient and enable use and control of the oral motor
 muscles within only a few treatments, for example, five to eight
 treatments. In contrast, known techniques often involve lengthy treatment
 periods, for example, of a year or more, and often do not enable the
 patient to successfully regain oral motor skills.
 An apparatus for treating oropharyngeal, respiratory, and oral motor
 neuromuscular disorders according to the present invention includes a
 plurality of electrodes adapted to provide selective electrical
 stimulation to the tissue of a patient and a pulse generator preferably
 coupled to each of the plurality of electrodes, for generating a series of
 electrical pulses. The pulse generator preferably includes a frequency
 controller, which modulates an electrical signal generated by the pulse
 generator at a predetermined frequency to produce the series of electrical
 pulses output by the pulse generator. The pulse generator also includes a
 duration control circuit for controlling the duration of time for which
 the pulse generator outputs the series of electrical pulses. An intensity
 control circuit regulates the series electrical pulses such that the
 electrical current does not exceed a predetermined current or voltage
 value. The predetermined current and voltage values may vary in accordance
 with the patient's physical condition and tolerances and the treatments
 performed.
 A method for treating oropharyngeal, respiratory, and oral motor
 neuromuscular disorders according to the present invention includes the
 steps of generating a series of electrical pulses using the pulse
 generator described above; generating operation control signals to control
 operation of the pulse generator; and applying the series of electrical
 pulses to the tissue of a patient to achieve neuromuscular stimulation of
 a patient.
 Another apparatus for treating oropharyngeal, respiratory, and oral motor
 neuromuscular disorders according to the present invention includes one or
 more pulse generators for generating a series of electrical pulses and a
 processor coupled to the pulse generators for outputting operation control
 signals to the pulse generators. A switching network is coupled to the
 pulse generators and the processor. The switching network receives the
 series of electrical pulses from the pulse generators and outputs the
 series of electrical pulses in accordance with switching control signals
 received from the processor. An electrode array is also coupled to the
 switching network. The electrode array applies the series of electrical
 pulses output by the switching network to tissue of a patient to achieve
 neuromuscular stimulation of the patient, and also generates electrical
 feedback signals in response to the neuromuscular stimulation of the
 patient. The electrical feedback signals are a provided to the processor
 via the switching network. The processor generates and stores test data
 and modifies the operation control signals and switching control signals
 in response to the electrical feedback signals.
 Another method for treating oropharyngeal, respiratory, and oral motor
 neuromuscular disorders according to the present invention includes the
 steps of generating a series of electrical pulses using one or more pulse
 generators; generating operation control signals to control operation of
 the pulse generators; receiving the series of electrical pulses from the
 pulse generators at a switching network; generating switching control
 signals to control operation of the switching network; outputting the
 series of electrical pulses from the switching network in accordance with
 the switching control signals; applying the series of electrical pulses to
 the tissue of a patient to achieve neuromuscular stimulation of a patient;
 generating electrical feedback signals in response to the neuromuscular
 stimulation of the patient; generating test data in response to the
 electrical feedback signals; and modifying the operation control signals
 and switching control signals in response to the electrical feedback
 signals.
 A novel size and arrangement of snap electrodes may be utilized to enable
 effective stimulation of the muscles and nerves in the respective regions
 of the patient. In this novel size and arrangement of snap electrodes,
 each snap electrode provides a halo or circle of electrical output, such
 that the electrical field is concentrated at the outer circumference of
 the electrode and not evenly dispersed over the surface of the electrode.
 This is in contrast to pin-type electrodes, commonly used in electrical
 stimulation applications, which provide an even, dispersed field of
 electrical output over the entire surface of the electrode. As a result of
 the concentration of the electrical output of snap electrodes around their
 circumferences, less electrical intensity is required to treat the patient
 when using snap electrodes than when using pin electrodes. Thus, the
 electrical output produced by the novel size and arrangement of snap
 electrodes according to the present invention enables the stimulated
 muscles to achieve stronger squeeze and contractility without exceeding
 the tolerance or comfort level of the patient. In contrast, achieving the
 same degree of squeeze and contractility with larger, standard electrodes
 requires the use of a substantially higher intensity of electrical
 stimulation, which frequently exceeds the tolerance or comfort level of
 the patient. Moreover, the size of a snap electrode may be reduced without
 decreasing the electrical output of the electrode, providing for
 additional treatment flexibility, such as treatment of small children.
 These and other aspects of the invention will be apparent to those skilled
 in the art upon reading and understanding the specification that follows.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
 The present invention will now be described in detail with reference to the
 accompanying drawings, which are provided as illustrative examples of
 embodiments of the invention only and not for purposes of limiting the
 same. In the drawings, like reference numerals indicate like elements
 throughout the several views.
 FIG. 1 illustrates a preferred embodiment of an electrical neuromuscular
 stimulation device 10 for providing electrical neuromuscular stimulus to
 specific regions of a patient in order to artificially promote swallowing,
 to treat respiratory disorders, or to provide neuromuscular stimulation to
 oral motor regions of the patient. The electrical neuromuscular
 stimulation device 10 as shown in FIG. 1 is comprised of a plurality of
 electrodes 12 (including individual electrodes 12a, 12b, and 12c) adapted
 to be selectively placed in electrical contact with tissue of a patient,
 and a pulse generator 20 for generating a series of electrical pulses,
 which is coupled to each of the plurality of electrodes 12.
 The device 10 preferably includes at least two electrodes 12a and 12b,
 although three electrodes (12a, 12b, and 12c) are shown in FIG. 1. For
 human applications, the electrodes 12a, 12b and 12c may preferably be snap
 electrodes having approximate measurements as follows: an
 eleven-millimeter diameter circular metal snap electrode affixed to the
 patient using strips of adhesive tape or using a circular adhesive pad for
 each electrode having an approximate radius of two millimeters greater
 than that of the electrode for adult applications. A three-eighths inch
 diameter circular metal snap electrode affixed with strips of adhesive
 tape or with a circular adhesive pad for each electrode having an
 approximate radius two-millimeters greater than that of the electrode may
 be used for child applications. The electrodes may alternatively be made
 of piezoelectric material. The adhesive portion of each electrode (e.g.,
 12a, 12b, and 12c) is preferably a conventional conductive skin adhesive
 manufactured from a polyethylene-glycol polymer. Because the conductivity
 of the adhesive is dependent on the water content in the polymer, the
 addition of a small amount of salt will further aid conduction by the
 adhesive. For child applications, hi-tack versions of the adhesive are
 preferred because of the small contact area. A hi-tack adhesive called
 RG-72 is available from the Promeon Company. The electrodes 12a, 12b and
 12c may also be any suitably conventional and convenient shapes that are
 suited for physiological applications.
 In a preferred embodiment, lead wires 14 are attached to each electrode and
 are suitable for attachment to the pulse generator 20. Lead wires 14 may
 be made from any physiologically acceptable conductive metal, preferably
 insulated aluminum or copper wire. Multistrand wire is preferable to "wire
 wrap" wire because multistrand wire is softer and less likely to break
 with repeated flexing.
 The series of electrical pulses is generated by selective control of pulse
 generator 20, which provides the series of electrical pulses to the
 plurality of electrodes 12 via an amplifier 18. Pulse generator 20
 preferably includes a frequency controller 22 (shown as separate component
 in FIG. 1) which modulates an electrical signal generated by the pulse
 generator at a predetermined frequency to produce the series of electrical
 pulses output by the pulse generator 20. The frequency controller 22 may
 modulate the electrical signal at a fixed frequency, for example, 80
 hertz, or may vary the frequency of the electrical pulses within a
 predetermined range of frequencies, for example, a range of frequencies
 from 4 to 80 hertz. Other frequency ranges as known in the art may also be
 used. Generally, the frequency of the electrical pulses is selected in
 order to provide the greatest comfort to the patient and to minimize as
 much as possible the amount of pin-prick sensation felt by the patient.
 The pulse generator 20 also preferably includes a duration control 24 for
 controlling the duration of time for which pulse generator 20 outputs the
 series of electrical pulses. The duration control 24 may control pulse
 generator 20 to output the electrical pulses for a fixed duration, for
 example, generally fixed at 300 microseconds. Alternatively, the duration
 control 24 may control pulse generator 20 to output the electrical pulses
 for varying durations within a predetermined range, for example a range of
 50 to 300 microseconds, and may further create one or more pauses of
 varying duration during the application of the electrical pulses to the
 patient s tissue. Other durations as known in the art may also be used.
 The duration control 24 may be adjusted manually or automatically using
 conventional circuits, such as a timer 40.
 In the embodiment depicted in FIG. 1, the generator is further comprised of
 an intensity control circuit 26 (shown as a separate component in FIG. 1)
 for regulating the series electrical pulses such that the electrical
 current does not exceed a predetermined current value, for example, 25
 milliamps RMS, and the power does not exceed a predetermined voltage
 value, for example, 9.6 MW RMS, or both. In a preferred embodiment, the
 intensity control circuit 26 limits the current and voltage values of the
 electrical pulses output by pulse generator 20 using conventional limiter
 circuits. The predetermined current and voltage values may vary in
 accordance with the patient's physical condition and tolerances and the
 treatments performed. Generally, the intensity of the current and voltage
 outputs is determined in order to provide the greatest comfort to the
 patient and to minimize as much as possible the amount of pin-prick
 sensation felt by the patient.
 For example, in treatment of oropharyngeal disorders, the current applied
 should be sufficient to produce the desired response and promote the
 swallowing reflex. The intensity of the current is increased by small
 increments until the swallow response or muscle fasciculation occurs.
 However, the current that is applied should not be too intense in order to
 avoid laryngeal spasms or cardiac arrhythmia in the patient.
 Similarly, in treatment of respiratory disorders, the amount of current
 applied should be selected so as not to adversely affect the function of
 the patient's heart or lungs. In the treatment of oral motor neuromuscular
 disorders, the intensity of the current applied and the placement of the
 electrodes are selected so as to avoid any damage to the patients tissue
 or skin. Accordingly, in a preferred embodiment of the present invention,
 a current of up to approximately 100 milliamps may be applied in
 respiratory and oral motor neuromuscular treatments.
 In the preferred embodiment depicted in FIG. 1, pulse generator 20 also
 includes an amplitude control circuit 28 (shown as a separate component in
 FIG. 1). Amplitude control circuit 28 allows for selective control of the
 amplitude of the electrical pulses generated by pulse generator 20 by
 manually or automatically operated conventional circuits as are known in
 the art.
 In a preferred embodiment, a channel selector 30 suitably forms another
 input to amplifier to allow for concurrent activation of additional sets
 of electrodes (not shown) using conventional switching circuits. The
 status of channel selector 30 is indicated by a channel selector indicator
 32.
 In one embodiment of the present invention, the pulse generator 20
 continuously generates electrical pulses for a predetermined period of
 time. For example, electric pulses may be continuously generated and
 delivered to the electrodes until a complete swallow is achieved or the
 sensory tolerance level is reached in the patient. Additional treatments
 wherein the generator continuously generates electric pulses are suitably
 performed on the patient as necessary.
 In an alternative embodiment of the present invention, the pulse generator
 20 selectively generates cycles of electrical pulses. In this embodiment,
 pulse generator 20 includes a treatment time control function, which is
 accomplished with intensity control 26 in response to real time
 information provided by timer 40. The timer 40, intensity control 26, and
 pulse generator 16 also serve to provide functions of treatment time
 control, on-ramp control, and off-ramp control.
 In a preferred embodiment, the treatment time control function selectively
 controls the duration of time wherein the pulse generator 20 selectively
 generates cycles of electric pulses. The treatment time is any suitable
 period, such as fifteen, thirty, or sixty minutes or continuous treatment.
 As with all settings, the particular values are highly specific to the
 application and patient. Thus, a suitable duration of the electric pulses
 in each cycle is manually or automatically set. In one embodiment
 according to the present invention, the duration of electric pulses in
 each cycle is within the range of 0.5 seconds to 30 seconds. Other
 durations as known in the art may also be used.
 In a preferred embodiment, the treatment time control function also
 selectively controls the amount of time between each treatment cycle. For
 example, the treatment time control may be set to provide a delay between
 treatment cycles ranging from 0.1 seconds, for example, for facial and
 respiratory treatments, to 60 seconds, for other oropharyngeal
 applications. Other ranges as known in the art may also be used.
 In a preferred embodiment, the on-ramp control function controls the amount
 of time required to reach the maximum intensity in each cycle. In one
 embodiment of the present invention, the amount of time required to reach
 the maximum intensity is between approximately 0.1 and 6.0 seconds.
 According to a preferred embodiment of the present invention, the maximum
 intensity in facial and respiratory treatments may be reached in 0.1
 second or less to reach the maximum intensity as rapidly as possible.
 Other times as known in the art may also be used.
 In a preferred embodiment, the off-ramp control function controls the
 amount of time required to decrease from the maximum intensity to zero
 intensity at the end of each cycle. In one embodiment of the present
 invention, the amount of time required to decrease from the maximum
 intensity to zero intensity is between approximately 0.1 and 6.0 seconds.
 Other times as known in the art may also be used.
 A suitable commercially available device that provides the functions
 described above is a Staodyn.sup.7 EMS+2 System manufactured by Staodyn,
 Inc. of Longmont, Colo.
 An alternative embodiment of a device for electrical neuromuscular
 stimulation according to the present invention will now be described with
 reference to FIG. 6.
 FIG. 6 illustrates a microprocessor-based stimulation device 600 according
 to the present invention including a microprocessor 601, a bi-directional
 analog switching network 602, and a plurality of pulse generators 603,
 604, 605 and 606. Microprocessor 601 controls the operation of pulse
 generators 603 through 606 by generating control signals indicating the
 parameters for generation of electrical pulses for each pulse generator
 603 through 606 respectively. For example, control signals provided by
 microprocessor 601 to each pulse generator 603 through 606 may include
 waveform, intensity, pulse width, ramp-on, and ramp-off control signals.
 Upon receipt of the respective control signals from microprocessor 601,
 pulse generators 603 through 606 generate electrical pulses and output the
 pulses to bi-directional analog switching network 602.
 In the preferred embodiment depicted in FIG. 6, microprocessor 601 is also
 coupled to bi-directional analog switching network 602 and provides
 control signal to switching network 602 to control the operation of
 switching network 602 in processing and selectively outputting the
 electrical pulses to a bidirectional electrode array 607 coupled to
 switching network 602.
 In the preferred embodiment depicted in FIG. 6, switching network 602
 receives electrical pulses generated by each of pulse generators 603
 through 606. Based upon the control signals from microprocessor 601 to
 switching network 602 control, switching network 602 outputs the
 electrical pulses from one or more of pulse generators 603 through 606 to
 electrodes 710, 702, 703 and 704 (various exemplary arrangements of
 electrodes are shown in FIGS. 7, 9A-E, and 12) in electrode array 607 via
 lead wires 710, 711, 712, and 713 respectively. The control signals from
 microprocessor 601 to switching network 602 determine, for example, the
 sequence in which the electrical pulses from each of pulse generators 603
 through 606 are provided to each electrode in electrode array 607 and the
 duration for which electrical pulses from each pulse generator will be
 provided to each electrode. Notably, switching network 602 may include one
 or more conventional buffer memories (not shown) to prevent overloading of
 the network.
 According to one embodiment of the present invention, microprocessor 601,
 switching network 602 and pulse generators 603 through 606 may be designed
 to provide maximum flexibility of operation. Thus, each of the pulse
 generators may be capable of providing electrical pulses having either
 fixed or variable current and voltage values, modulation rates and
 frequencies. The waveform, intensity, and ramp-on and ramp-off functions
 provided by each pulse generator 603 through 606 may also be variably
 selected. Stimulation device 600 allows each of pulse generators 603
 through 606 to independently produce simultaneous and/or sequential
 stimulation by each of the electrodes in electrode array 607. Generally,
 the waveform and intensity of the electrical pulses is selected and/or
 pre-programmed in order to provide the greatest comfort to the patient and
 to minimize as much as possible the amount of pin-prick sensation felt by
 the patient.
 In the preferred embodiment depicted in FIG. 6, microprocessor 601 is
 coupled to a programming device 608, which enables the microprocessor to
 be programmed to perform the processing functions in accordance with the
 present invention. Data may also be provided to microprocessor 601 by
 programming device 608. Programming of microprocessor 601 and downloading
 of data to the microprocessor may be accomplished through a conventional
 interface, such as standard RS232 serial and parallel ports or infrared
 links, as is known in the art.
 Stimulation device 600 depicted in FIG. 6 also includes a feedback network
 for receiving and processing feedback received from electrode array 607.
 For example, electrode array 607 may use electromyographic (EMG) sensing
 capabilities to generate electrical feedback signals. The EMG sensing
 capabilities are utilized, for example, to determine whether muscles are
 contracting and, if so, the sequence of muscle contractions. This
 information may be used to adjust the electrical pulses supplied to
 stimulate these muscles. In treatments of oropharyngeal disorders, muscle
 contraction information may also be used to identify the patient's
 attempts to swallow, enabling the stimulator to facilitate the remainder
 of the swallowing sequence.
 The feedback signals generated by electrode array 607 are provided to
 switching network 602 that outputs the feedback signals to a receiver
 amplifier 613. Receiver amplifier 613 amplifies the feedback signals and
 outputs the amplified feedback signals to a conversion circuit 612.
 Conversion circuit 612 formats the amplified feedback signals into a
 selected signal format and outputs the formatted feedback signals to an
 input processor 611. The selected signal format into which conversion
 circuit 612 converts the feedback signals is selected to enable input
 processor 611 to download and process the feedback signals.
 In the preferred embodiment depicted in FIG. 6, input processor 611 also
 optionally receives one or more physiological and/or non-physiological
 inputs from input devices 615, 616, 617, 618, 619, 620 and 621. The
 physiological input devices such as devices 616, 617, 618, 619 and 620
 provide inputs representing various physiological characteristics of the
 patient. For example, physiological inputs may be received from such
 devices as an accelerometer 616 (indicating motion due to a contraction of
 the muscle during swallowing), a manometry device 617 (indicating pressure
 increase due to the attempt at swallowing), a video fluoroscopy device 618
 (for providing an input from visual examination of the patient's
 swallowing mechanism to determine the effectiveness of the swallow), an
 EMG device 619 (indicating muscle movements in the oral motor muscles
 and/or swallowing mechanism which may not be detected by the electrode
 stimulation patch), and/or an acoustic signaling device 620, e.g., a
 microphone placed on the neck of the patient, to detect speech and/or
 swallowing sounds.
 Non-physiological devices such as device 615 may provide inputs
 representing various non-physiological characteristics of the patient.
 Non-physiological inputs may be received from such sources as
 therapist/patient/doctor input device 615 which enables a therapist,
 patient and/or doctor to enter information such as the patient's threshold
 for the stimulation device parameters, including a minimum threshold
 needed and the maximum intensity usable for the patient, as well as
 parameters for altering the sequence and intensity of electrode
 stimulation for the patient based upon asymmetries which the patient may
 have during the swallowing process, respiratory process or oral motor
 stimulation process.
 Additional factors such as height, weight, neck thickness/size, torso
 measurements, facial dimensions, pain tolerance, and the current status of
 the patient's ability to swallow, breathe, or control oral motor muscles
 may be entered for use in determining the appropriate stimulation
 frequency patterns and intensities (depending on the type of treatment).
 Additional physiological and/or non-physiological inputs may be received
 from other devices as indicated by representative input device 621.
 In a preferred embodiment, the physiological and non-physiological inputs
 respectively generated by physiological and non-physiological input
 devices 615 through 620 are formatted by a conversion circuit 614 (similar
 to conversion circuit 612) and then stored and processed by input
 processor 611. Input processor 611 processes and stores as test data both
 the feedback signals originated by electrode array 607 and physiological
 and non-physiological inputs from devices 615 through 620. Input processor
 also receives control signals and data inputs from microprocessor 601.
 In the preferred embodiment depicted in FIG. 6, a system and patient
 interaction display 610 is optionally provided. Display 610 is coupled to
 microprocessor 601 and receives processed data from input processor 611
 via microprocessor 601. In this manner, display 610 enables monitoring of
 the feedback signals from electrode array 607 in addition to the status of
 inputs from the various physiological and non-physiological inputs 615
 through 620 as described above. Display 610 may also enable monitoring of
 the operating status of stimulation device 600.
 The display 610 may display a variety of parameters, inputs, and outputs as
 may be desired. For example, display 610 may show current patient
 parameters, current inputs from the physiological and non-physiological
 devices and the electrode stimulation array, an overall rating of
 swallowing capability and current swallowing effectiveness, respiratory
 capacity and capability, or degree of oral motor muscle control (depending
 on the type of treatment), and the current setting(s) of the stimulation
 pattern frequency and/or intensity. Additionally, the display 610 may be
 adapted for monitoring by the patient to provide feedback to the patient
 as to how well swallowing has been completed. This feedback to the patient
 may assist with the patient's inherent bio-feedback mechanisms.
 In the preferred embodiment depicted in FIG. 6, a data/software I/O
 interface 609 is optionally provided to enable downloading of testing data
 collected and processed by stimulation device 600, for example, during
 patient treatments. Patient-specific data may be downloaded to external
 devices, including portable devices, through any conventional interface
 (e.g., a hardwired interface, coaxial interface, infrared interface,
 etc.).
 Treatment of Oropharyngeal Disorders
 A preferred embodiment of a bi-directional electrode array 607 for use in
 conjunction with stimulation device 600 for treatment of oropharyngeal
 disorders is illustrated in FIG. 7. Each bi-directional electrode in array
 607 stimulates one or more pharyngeal muscles with electrical stimulation
 provided by the switching network 602, detects the electromyographic (EMG)
 response from the stimulated muscle(s), and provides the EMG response as
 an electrical feedback signal to the switching network 602.
 Notably, the arrangement of electrodes and connecting wires shown in FIG. 7
 is provided as an example and is not intended to limit the scope of the
 present invention. Uni-directional electrodes (stimulating muscles but not
 sensing EMG signals from the stimulated muscles) may also be used in
 accordance with the present invention. Also, multiple electrodes,
 including squares of four, sixteen, twenty-five, or thirty-six electrodes
 or more, may be used. As the number of electrodes increases, the surface
 area treated by the array may be increased and/or the electrodes may be
 more closely positioned.
 As shown in FIG. 7, array 607 preferably comprises bi-directional four
 electrodes 701, 702, 703 and 704, which are positioned on the tissue of
 the pharyngeal region of a patient using adhesive bands 705 and 706 as
 illustrated in FIG. 7A or with circular adhesive regions surrounding each
 metal electrode. The electrodes may preferably be arranged in two pairs or
 in a vertical row of four electrodes. In yet other preferred embodiments
 (not shown), alternative electrode arrangements may be used to achieve
 elevation of the patient's larynx.
 In the two-pair electrode arrangement, each pair of electrodes (701, 703)
 is positioned on one lateral side (e.g., the right hand or left hand side)
 of the pharyngeal region of the patient, with one electrode positioned
 above the patient's Adams Apple and the other below the Adams Apple of the
 patient. The second pair of electrodes (702, 704) is positioned in the
 same arrangement on the opposite side of the patient's pharyngeal region.
 Each pair of electrodes may preferably be positioned such that the
 distance between the centers of the electrodes, shown as distance "X" in
 FIG. 7, may be approximately three to four centimeters or other spacing as
 required to position the electrodes on the pharyngeal region of the
 patient as described above. The pairs of electrodes may preferably be
 spaced at a distance, shown as distance "Y" in FIG. 7, of approximately
 two and a half centimeters or other spacing as required to position the
 electrodes on the pharyngeal region of the patient as described above. In
 the two-pair electrode arrangement described above, the two electrodes
 (701, 703) positioned on one lateral side (e.g., right or left side) of
 the patient's pharyngeal region are coupled to a first output channel of
 the switching network 602, and the two electrodes (702, 704) positioned on
 the other lateral side of the patient's pharyngeal region are coupled to a
 second output channel of the switching network 602.
 In the vertical row electrode arrangement (not shown), the four electrodes
 are positioned in a vertical row directly adjacent to one another, but not
 overlapping, starting with a first uppermost electrode being positioned on
 the patient's digastric muscles, covering the hyoid and the strap muscles
 of the patient's larynx, and ending with a fourth lowermost electrode
 being positioned at the base of the patient's thyroid cartilage. In the
 vertical row electrode arrangement described above, the two upper
 electrodes in the row are coupled to a first output channel of the
 switching network 602, and the two lower electrodes in the row are coupled
 to a second output channel of the switching network 602.
 The electrodes 701, 702, 703 and 704 may preferably be snap electrodes
 having the following approximate dimensions: an eleven-millimeter diameter
 circular metal snap electrode positioned on an adhesive band as shown in
 FIG. 7A or using a circular adhesive pad for each electrode having an
 approximate radius of two millimeters greater than that of the electrode
 for adult applications. A three-eighths inch diameter circular metal snap
 electrode affixed with an adhesive band, strips of adhesive tape, or a
 circular adhesive pad for each electrode having an approximate radius
 two-millimeters greater than that of the electrode may be used for child
 applications. The electrodes 701-704 may also be any suitably conventional
 and convenient shape that is suited for physiological applications.
 The adhesive bands used to attach each pair of electrodes in array 607 to
 the patient may have a width of approximately eight centimeters, shown as
 distance "A" in FIG. 7. Contact pads 707 and 708 having a width of
 approximately eight and a half centimeters (shown as distance "B" in FIG.
 7) are also provided.
 The adhesive portions may be preferably made of a conventional conductive
 skin adhesive such as a polyethylene-glycol polymer. Because the
 conductivity of such adhesives may be dependent on the water content in
 the polymer, the addition of a small amount of salt may further aid
 conduction by the adhesive. For child applications, hi-tack versions of
 the adhesive are preferred because of the small contact area. Other
 suitable adhesive materials may also be used as would be apparent to those
 of skill in the art.
 In a preferred embodiment, each electrode of electrode array 607 is
 independently coupled to an output of switching network 602 (shown in FIG.
 6) by lead wires 710, 711, 712, and 713 respectively. As a result, each
 electrode independently receives one or more series of electrical pulses
 generated by one or more of pulse generators 603-606 via switching network
 602 as determined by microprocessor 601. Microprocessor 601 controls the
 switching operation of switching network 602 to control which output or
 outputs from pulse generators 603-606 are provided to each electrode in
 electrode array 607.
 Several alternative two-electrode arrangements for the placement of
 electrodes on the tissue of the pharyngeal region of a patient will now be
 described in detail with reference to FIGS. 3, 4 and 7. These arrangements
 are provided as examples of electrode placement and are not intended to
 limit the number and arrangement of electrodes for use in practicing the
 present invention.
 The electrodes are selectively placed in any suitable site within the
 pharyngeal region 200 of the patient as shown in FIGS. 3, 4 and 7. The
 placement of the electrodes in the pharyngeal region of the patient is
 based on several factors, such as the extent and type of oropharyngeal
 disorder exhibited by the patient and, given the extent and type of
 oropharyngeal disorder exhibited, those locations within the pharyngeal
 region, when subjected to electrical stimulus, have the possibility of
 eliciting the strongest and most complete swallow. An evaluation for
 swallowing ability is done on the patient to determine the extent and type
 of oropharyngeal disorder. The critical elements in the evaluation are
 analysis by video fluoroscopy and clinical evaluation to determine the
 presence of a gag reflex, a dry swallow, and ability to tolerate one's own
 secretions. The placement of the electrodes may be changed several times
 in an effort to obtain the strongest and most effective treatment.
 In a two-electrode embodiment of the present invention, a pair of
 electrodes 202 is positioned on the skin of the pharyngeal region 200 at
 approximately the position of the lesser horn 204 of the hyoid bone 206 on
 either side of the pharyngeal region 200 and just above the body of the
 hyoid bone 206. The electrodes overlie the muscles of the floor of the
 mouth (not shown).
 In an alternative two-electrode embodiment of the present invention, a pair
 of electrodes 208 is positioned on the side of the pharyngeal region 200
 on one side of the midline of the pharyngeal region 200. One electrode
 208a is placed on the thyrohyoid membrane 210 at approximately the level
 of the lesser horn 204 close to the hyoid bone 206. This electrode 208a
 overlies the sternothyroid muscle 212 and the thyrohyoid muscle 214. The
 other electrode 208b is placed on the cricoid cartilage 216 to the side of
 the midline of the pharyngeal region 200. This electrode overlies the
 sternothyroid muscle 218 and the sternothyroid muscle 212 on one side of
 the midline of the pharyngeal region.
 In another embodiment of the present invention, a pair of electrodes 220 is
 positioned on the skin of the pharyngeal region 200 on the thyrohyoid
 membrane 210 on either side of the midline of the pharyngeal region 200.
 These electrodes overlie the thyrohyoid muscle 214 and the sternothyroid
 muscle 218.
 In yet another embodiment of the present invention, a pair of electrodes
 222 is positioned on the skin of the pharyngeal region 200 on either side
 of the midline of the pharyngeal region 200 proximately midway between the
 thyroid notch 224 and the cricoid cartilage 216. These electrodes overlie
 the sternothyroid muscle 218 and the transition zone between the
 stemothyroid muscle 212 and the thyrohyoid muscle 214 on either side of
 the midline of the pharyngeal region 200.
 In an additional embodiment of the present invention, a pair of electrodes
 226 is positioned on the skin of the pharyngeal region 200 on one side of
 the midline of the pharyngeal region 200. One electrode 226a is placed
 just lateral to the lesser horn 204 of the hyoid bone 206 proximately
 midway between the hyoid bone 206 and the lower border of the mandible
 (not shown). This electrode overlies the mylohyoid muscle 228 and the
 digastric muscle 230. The other electrode 226b is placed proximate to the
 upper end of the thyrohyoid membrane 210 and proximate to the hyoid bone
 206 or on the hyoid bone 206 proximately at the level of the lesser horn
 204 of the hyoid bone 206. This electrode overlies the sternothyroid
 muscle 212 and the thyrohyoid muscle 214.
 In a further embodiment of the present invention, a pair of electrodes 232
 is positioned on the skin of the pharyngeal region 200 to the side of the
 midline of the pharyngeal region 200. One electrode 232a is placed on the
 midline of the pharyngeal region near the chin (not shown). The other
 electrode 232b is placed laterally to the other electrode. These
 electrodes overlie 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 dimensions of the electrodes in accordance
 with the present invention is performed so as to avoid the carotid body
 and to insure the safety of the patient.
 A preferred method for electrical pharyngeal neuromuscular stimulation
 using the apparatus shown in FIG. 1 will now be described with reference
 to FIG. 2. Turning to start procedure step 100, the procedure for treating
 oropharyngeal disorders with electrical stimulation is initiated. Next, at
 apply electrodes to patient step 102, actual electrodes are applied to the
 pharyngeal area of a patient. The particulars for electrode placement and
 selection are described in detail below with reference to FIGS. 3, 4 and
 7.
 Turning next to set pulse frequency step 104, a pulse frequency is set in
 accordance with the parameters disclosed above. Similarly, at set pulse
 duration step 106, pulse duration is set. Finally, at determine treatment
 time step 108, a determination of a treatment duration is made, as well as
 to the number of treatment periods that are to be applied.
 Turning next to apply waveform step 110, an actual waveform associated with
 the previously selected parameters is applied to the pharyngeal area of a
 patient. Next, at decision step 112, a determination is made as to whether
 a treatment period is complete in accordance with the preselected
 standards. A positive determination causes progress to decision step 114
 and a negative determination causes progress to wait for duration step
 116. At wait for duration step 116, the device automatically waits for a
 predetermined period of time before returning to apply waveform step 110.
 At decision step 114, a determination is made as to whether further
 treatment periods are merited. A positive determination causes a return to
 wait set duration step 110. A negative determination results in completion
 of the treatment procedure as indicated by end procedure step 118.
 With reference to FIG. 8, an alternative embodiment of a preferred method
 for electrical pharyngeal neuromuscular stimulation according to the
 present invention includes the steps of:
 801: generating a series of electrical pulses using one or more pulse
 generators;
 802: generating operation control signals to control operation of the pulse
 generators;
 803: receiving the series of electrical pulses from the pulse generators at
 a switching network;
 804: generating switching control signals to control operation of the
 switching network;
 805: outputting the series of electrical pulses from the switching network
 in accordance with the switching control signals;
 806: applying the series of electrical pulses to tissue of a pharyngeal
 region of a patient using an electrode array to achieve neuromuscular
 stimulation of a patient;
 807: generating electrical feedback signals in response to the
 neuromuscular stimulation of the patient;
 808: generating test data in response to the electrical feedback signals;
 and
 809: modifying the operation control signals and switching control signals
 in response to the electrical feedback signals.
 This method may further include the step of:
 810: generating physiological and/or non-physiological input signals using
 at least one physiological and/or non-physiological input device.
 When step 810 is included, the test data generated in step 808 above is
 also based upon the physiological and/or non-physiological input signals.
 Similarly, step 809 above includes the modification of the operation
 control signals and switching of control signals in response to both the
 electrical feedback signals and the physiological and/or non-physiological
 input signals.
 The preferred method depicted in FIG. 8 may optionally include the steps of
 monitoring the electrical feedback signals, the physiological input
 signals, the non-physiological input signals, or any combination thereof
 and downloading the test data to a test data receiver, for example, an
 external receiving device.
 The practice of various embodiments of the method according to the present
 invention will now be described in further detail. In the following
 examples, the inventive method was used to treat dysphagia. These examples
 are not intended to limit the scope of the present invention.
 EXAMPLE 1
 One hundred and ninety-five patients suffering from dysphagia as a result
 of a 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 swallowing ability of each patient was
 assigned a number which corresponds to a defined swallow state wherein the
 swallow states are listed below: swallow state zero is the inability to
 have a pharyngeal contraction; swallow state one is the ability to swallow
 one's own secretions; swallow state two is the ability to swallow paste,
 pudding, or similar substances; swallow state three is the ability to
 swallow honey or similar substances; swallow state four is the ability to
 swallow nectar or similar substances; swallow state five is the ability to
 swallow liquids; and swallow state six is the ability to swallow water.
 All of the patients were determined to have swallowing states of either
 zero or one, indicating the patient did not have a complete pharyngeal
 contraction and had no gag reflex or the ability to handle secretions. The
 patients were then objected to a series of treatment sessions. The
 patients were divided into two treatment groups: electrical stimulation
 and thermal stimulation.
 Sixty three patients underwent a series of electrical stimulation treatment
 sessions. Preferably, the patients underwent a least seven electrical
 stimulation treatment sessions. In each treatment session, electrodes were
 selectively placed on the skin of the pharyngeal region of the patient.
 The placement 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, those locations within the pharyngeal region, when
 subjected to electrical stimulus, have the possibility of eliciting the
 strongest and most complete swallow. Electrode placement was adjusted
 until the patient achieved the most complete swallowing contraction for
 which he was capable. Once the correct electrode placement was determined,
 the intensity of the current was increased by small increments until the
 tolerance and comfort level limits are reached in the patient. The optimal
 intensity was realized when the patient felt a tugging or pinch in the
 area of stimulation. The patient was then subjected to continuous
 electrical stimulation wherein electric pulses were continuously generated
 and delivered to the electrodes until a complete swallow was achieved or
 the tolerance level was reached in the patient. This step was repeated
 five to twenty times in each treatment session wherein the patient was
 subjected to continuous electrical stimulation. If the electrical
 stimulation was successful in promoting a complete contraction, swabbing
 of the oral cavity was done and the patient attempted a dry swallow. In
 those patients who did not exhibit any pharyngeal contraction, one or more
 treatment sessions were required before an adequate dry swallow occurred.
 Once an adequate dry swallow was achieved, oral intake was provided to
 assist in the treatment. The consistency of the oral intake was determined
 by the strength of the contraction elicited by the patient. If the patient
 was able to swallow his own saliva, swabbing the oral cavity with a sponge
 moistened by water or juice was performed. The patient attempted to
 swallow the water or juice while subjected to continuous electrical
 stimulation. Once the patient had achieved audible, strong contractions,
 the patient was challenged with pudding, thick liquid, or ice slush. The
 patient attempted to swallow these substances while subjected to
 continuous electrical stimulation. Once three to five strong swallows were
 achieved with the assistance of electrical stimulation, the patient
 attempted to swallow these substances without the assistance of electrical
 stimulation. Treatment sessions continued with each patient until the
 patient's improvement reached a plateau.
 Thirty-one patients were subjected to a series of thermal stimulation
 treatment sessions. Preferably, the patients were subjected to a least
 seven thermal stimulation treatment sessions. In each treatment session, a
 mirror or probe was immersed in ice or cold substance. The tonsillar fossa
 was stimulated with the mirror or probe. The patient then closed his mouth
 and attempted a dry swallow. If the stimulation was successful in
 promoting a complete contraction, oral intake was provided to assist in
 the treatment. The consistency of the oral intake was determined by the
 strength of the contraction elicited by the patient. Once an adequate dry
 swallow was achieved, oral intake was provided to assist in the treatment.
 The consistency of the oral intake was determined by the strength of the
 contraction elicited by the patient. If the patient was able to swallow
 his own saliva, swabbing the oral cavity with a sponge moistened by water
 or juice was performed. The patient attempted to swallow the water or
 juice while subjected to thermal stimulation. Once the patient had
 achieved audible, strong contractions, the patient was challenged with
 pudding, thick liquid, or ice slush. The patient attempted to swallow
 these substances while subjected to thermal stimulation. Once three to
 five strong swallows were achieved with the assistance of thermal
 stimulation, the patient attempted to swallow these substances without the
 assistance of thermal stimulation. Treatment sessions continued with each
 patient until the patient's improvement plateaus. Once the patient had
 achieved audible, strong contractions, the patient was challenged with
 pudding, thick liquid, or ice slush. The patient attempted to swallow
 these substances while subjected to continuous electrical stimulation.
 Once three to five strong swallows were achieved with the assistance of
 electrical stimulation, the patient attempted to swallow these substances
 without the assistance of thermal stimulation. Treatment sessions
 continued with each patient until the patient's improvement plateaus.
 The effectiveness of the electrical stimulation treatments and the thermal
 stimulation treatments is shown in FIG. 5. FIG. 5 is a graph illustrating
 the mean swallowing state achieved after electrical stimulation treatment
 sessions and thermal stimulation treatments. After seven treatment
 sessions, the mean swallowing state of the patients treated with
 electrical stimulation was swallow state five, or the ability to swallow
 thin liquids. After seven treatment sessions, the mean swallowing state of
 the patients treated with thermal stimulation was only swallow state one,
 or the ability to handle one's own secretions.
 The method and device for electrical pharyngeal neuromuscular stimulation
 of the present invention provides an effective and non-invasive treatment
 for dysphagia. The method and device for electrical pharyngeal
 neuromuscular stimulation is more effective for treating dysphagia than
 traditional treatment methods, such as thermal stimulation. Further, the
 method and device of the present invention is effective for treating
 worst-case dysphagia resulting from neurodegeneration and strokes.
 Treatment of Respiratory Disorders
 The device described above with reference FIGS. 1 and 6 above may further
 be used to treat respiratory disorders, such as asthma, bronchitis, and
 chronic obstructive pulmonary disease, and to treat ventilator dependence
 conditions by providing electrical neuromuscular stimulation to the
 intercostal muscles between the ribs of a patient.
 The electrodes used in treatment of respiratory disorders are preferably
 uni-directional or bidirectional snap electrodes having an
 eleven-millimeter diameter circular metal snap electrode surrounded by an
 annular adhesive portion approximately two millimeters wide may be used
 for adult applications. A three-eighths inch diameter circular metal snap
 electrode affixed to the patient using strips of adhesive tape or using a
 circular adhesive pad for each electrode having an approximate radius of
 two millimeters greater than that of the electrode may be used for adult
 applications. A three-eighths inch diameter circular metal snap electrode
 affixed with strips of adhesive tape or with a circular adhesive pad for
 each electrode having an approximate radius two-millimeters greater than
 that of the electrode may be used for child applications. The adhesive
 portions are preferably made of a conventional conductive skin adhesive
 such as a polyethylene-glycol polymer. Because the conductivity of the
 adhesive is dependent on the water content in the polymer, the addition of
 a small amount of salt will further aid conduction by the adhesive. For
 child applications, hi-tack versions of the adhesive are preferred because
 of the small contact area. However, the electrodes may also be any
 suitably conventional and convenient shape that is suited for
 physiological applications.
 Various exemplary electrode configurations will now be described with
 reference to FIGS. 9A-E. These arrangements are provided as examples of
 electrode placement and are not intended to limit the number and
 arrangement of electrodes for use in practicing the present invention.
 According to a preferred embodiment of the present invention, treatment of
 respiratory disorders such as asthma and asthma-type symptoms may be
 performed by placing one uni-directional circular snap electrode on the
 intercostal muscle between the patient's third and fourth anterior ribs
 and one unidirectional circular snap electrode on the intercostal muscle
 between either the patient's fourth and fifth or fifth and sixth anterior
 ribs. Both electrodes are positioned on the same side (left or right side,
 depending on the patient's condition) of the patient, applying a total of
 two circular uni-directional snap electrodes (901 and 902) in this
 embodiment, as shown in FIG. 9A (showing left side placement only). Each
 electrode is placed in proximity to, but not touching, the patient's
 sternum.
 According to another preferred embodiment of the present invention,
 treatment of respiratory disorders may be performed by placing one
 bi-directional circular snap electrode on the intercostal muscle between
 the patient's third and fourth anterior ribs on each side of the patient
 and one bi-directional circular snap electrode on the intercostal muscle
 between either the patient's fourth and fifth or fifth and sixth anterior
 ribs on each side of the patient. Thus, a total of four circular
 bi-directional snap electrodes (903, 904, 905 and 906) are applied in this
 embodiment, as shown in FIG. 9B. Each electrode is placed in proximity to,
 but not touching, the patient's sternum.
 According to yet another preferred embodiment of the present invention,
 treatment of ventilator dependence conditions may be performed by placing
 one bi-directional rectangular two-inch snap electrode in the intercostal
 space between the patient's seventh and eighth anterior ribs on each side
 of the patient and one bi-directional rectangular two-inch snap electrode
 in the intercostal space between the patient's eighth and ninth anterior
 ribs on each side of the patient. Thus, a total of four rectangular
 bi-directional snap electrodes (910, 911, 912, and 913) are applied in
 this embodiment, as shown in FIG. 9C.
 According to another preferred embodiment of the present invention,
 treatment of respiratory disorders such as bronchitis and chronic
 obstructive pulmonary disorder (COPD) may be performed by placing one
 unidirectional circular snap electrode on the intercostal muscle between
 the patient's second and third anterior ribs and one uni-directional
 circular snap electrode on the intercostal muscle between the patient's
 third and fourth anterior ribs. Both electrodes are placed on the same
 side (either the right or left side, depending on the patient's condition)
 of the patient. Thus, a total of two circular unidirectional snap
 electrodes (914 and 915) are applied in this embodiment, as shown in FIG.
 9D (showing left side placement only). Each electrode is placed in
 proximity to, but not touching, the patient's sternum.
 According to another preferred embodiment of the present invention,
 treatment of respiratory disorders such as bronchitis and COPD may be
 performed by placing one bidirectional circular snap electrode on the
 intercostal muscle between the patient's second and third anterior ribs on
 each side of the patient and one bi-directional circular snap electrode on
 the intercostal muscle between the patient's third and fourth anterior
 ribs on each side of the patient. Thus, a total of four circular
 bidirectional snap electrodes (916, 917, 918 and 919) are applied in this
 embodiment, as shown in FIG. 9E. Each electrode is placed in proximity to,
 but not touching, the patient's sternum.
 Other arrangements and placements of electrodes may also be used in
 accordance with the present invention as would be apparent to those of
 skill in the art.
 As illustrated in FIG. 10, a method for treating respiratory disorders
 according to the present invention using the electrical neuromuscular
 stimulator shown in FIG. 1 includes the following steps:
 1001: applying electrodes to the intercostal regions of a patient as
 described above with reference to FIGS. 9A-E.
 1002: setting a pulse frequency in accordance with the parameters disclosed
 above with reference to FIG. 1.
 1003: setting a pulse duration.
 1004: setting a treatment duration, as well as to the number of treatment
 periods that are to be applied.
 1005: applying a waveform associated with the previously selected
 parameters to the intercostal regions of the patient as described above
 with reference to FIGS. 9A-E.
 1006: determining whether a treatment period is complete in accordance with
 preselected standards.
 1007: a positive determination causes progress to decision step 1010.
 1008: a negative determination causes the device to wait for a duration as
 defined in step 1009.
 1009: pausing for a predetermined period of time before returning to apply
 waveform step 1005.
 1010: determining whether further treatment periods are merited. A positive
 determination causes a return to wait for duration step 1009. A negative
 determination results in completion of the treatment procedure as
 indicated by end procedure step 1011.
 As shown in FIG. 11, an alternative method for treating respiratory
 disorders according to the present invention using the electrical
 neuromuscular stimulator shown in FIG. 6 includes the following steps:
 1101: generating a series of electrical pulses using one or more pulse
 generators;
 1102: generating operation control signals to control operation of the
 pulse generators;
 1103: receiving the series of electrical pulses from the pulse generators
 at a switching network;
 1104: generating switching control signals to control operation of the
 switching network;
 1105: outputting the series of electrical pulses from the switching network
 in accordance with the switching control signals;
 1106: applying the series of electrical pulses to tissue of at least one
 intercostal region of a patient and using an electrode array as described
 above with reference to FIGS. 9A-E to achieve neuromuscular stimulation of
 the patient;
 1107: generating electrical feedback signals in response to the
 neuromuscular stimulation of the patient;
 1108: generating test data in response to the electrical feedback signals;
 and
 1109: modifying the operation control signals and switching control signals
 in response to the electrical feedback signals.
 This method may further include the step of:
 1110: generating physiological and/or non-physiological input signals using
 at least one physiological and/or non-physiological input device.
 When step 1110 is included, the test data generated in step 1108 above is
 also based upon the physiological and/or non-physiological input signals.
 Similarly, step 1109 above includes the modification of the operation
 control signals and switching of control signals in response to both the
 electrical feedback signals and the physiological and/or nonphysiological
 input signals.
 The preferred method depicted in FIG. 11 may optionally include the steps
 of monitoring the electrical feedback signals, the physiological input
 signals, the non-physiological input signals, or any combination thereof
 and downloading the test data to a test data receiver, for example, an
 external receiving device.
 Treatment of Oral Motor Neuromuscular Damage and Disorders
 The device described above with reference FIGS. 1 and 6 above may further
 be used to treat oral motor neuromuscular damage and disorders by
 providing electrical neuromuscular stimulation at specific oral motor
 points on the face of a patient.
 The electrodes used in treatment of oral motor neuromuscular disorders are
 preferably uni-directional or bi-directional snap electrodes having an
 eleven-millimeter diameter circular metal snap electrode surrounded by an
 annular adhesive portion approximately two millimeters wide may be used
 for adult applications. A three-eighths inch diameter circular metal snap
 electrode affixed to the patient using strips of adhesive tape or using a
 circular adhesive pad for each electrode having an approximate radius of
 two millimeters greater than that of the electrode may be used for adult
 applications. A three-eighths inch diameter circular metal snap electrode
 affixed with strips of adhesive tape or with a circular adhesive pad for
 each electrode having an approximate radius two-millimeters greater than
 that of the electrode may be used for child applications. The adhesive
 portions are preferably made of a conventional conductive skin adhesive
 such as a polyethylene-glycol polymer. Because the conductivity of the
 adhesive is dependent on the water content in the polymer, the addition of
 a small amount of salt will further aid conduction by the adhesive. For
 child applications, hi-tack versions of the adhesive are preferred because
 of the small contact area. However, the electrodes may also be any
 suitably conventional and convenient shape that is suited for
 physiological applications.
 Various exemplary electrode configurations will now be described with
 reference to FIG. 12. These arrangements are provided as examples of
 electrode placement and are not intended to limit the number and
 arrangement of electrodes for use in practicing the present invention.
 With reference to FIG. 12, treatment of oral motor neuromuscular damage
 and/or disorders may be performed by placing one unidirectional circular
 snap electrode in front of the Targus and the Tempro Mandibular Joint. A
 second uni-directional circular snap electrode is placed overlying the
 neck of the mandible at the N. Facial (Trunk). Thus, a total of two
 circular unidirectional snap electrodes (1201 and 1202) are applied to the
 oral motor region on one side of the patient's face (either the left or
 right side, depending on the patient's condition).
 An alternative treatment (not shown) of oral motor neuromuscular damage
 and/or disorders may be performed by placing one bi-directional circular
 snap electrode in front of the Targus and the Tempro Mandibular Joint on
 each side of the patient's face and one bi-directional circular snap
 electrode overlying the neck of the mandible at the N. Facial (Trunk) on
 each side of the patient's face. Thus, a total of four circular
 bi-directional snap electrodes are applied to the patient's oral motor
 region in this embodiment.
 As shown in FIG. 13, a method for treating oral motor neuromuscular damage
 and/or disorders according to the present invention using the electrical
 neuromuscular stimulator shown in FIG. 1 includes the following steps:
 1300: initiating the procedure for treating respiratory disorders with
 electrical stimulation.
 1301: applying electrodes to the tissue of the oral motor region of a
 patient as described above with reference to FIG. 12.
 1302: setting a pulse frequency in accordance with the parameters disclosed
 above with reference to FIG. 1.
 1303: setting a pulse duration.
 1304: setting a treatment duration is made, as well as to the number of
 treatment periods that are to be applied.
 1305: applying a waveform associated with the previously selected
 parameters to the face of the patient as described above with reference to
 FIG. 12.
 1306: determining whether a treatment period is complete in accordance with
 preselected standards.
 1307: a positive determination causes progress to decision step 1310.
 1308: a negative determination causes the device to wait for a duration
 determined in step 1309.
 1309: pausing for a predetermined period of time before returning to apply
 waveform step 1305.
 1310: determining whether further treatment periods are merited. A positive
 determination causes a return to wait for duration step 1309. A negative
 determination results in completion of the treatment procedure as
 indicated by end procedure step 1312.
 As shown in FIG. 14, an alternative method for treating oral motor
 neuromuscular damage and/or disorders according to the present invention
 using the electrical neuromuscular stimulator shown in FIG. 6 includes the
 following steps:
 1401: generating a series of electrical pulses using one or more pulse
 generators;
 1402: generating operation control signals to control operation of the
 pulse generators;
 1403: receiving the series of electrical pulses from the pulse generators
 at a switching network;
 1404: generating switching control signals to control operation of the
 switching network;
 1405: outputting the series of electrical pulses from the switching network
 in accordance with the switching control signals;
 1406: applying the series of electrical pulses to the face of a patient
 using an electrode array as described above with reference to FIG. 12 to
 achieve neuromuscular stimulation of a patient;
 1407: generating electrical feedback signals in response to the
 neuromuscular stimulation of the patient;
 1408: generating test data in response to the electrical feedback signals;
 and
 1409: modifying the operation control signals and switching control signals
 in response to the electrical feedback signals.
 This method may further include the step of:
 1410: generating physiological and/or non-physiological input signals using
 at least one physiological and/or non-physiological input device.
 When step 1410 is included, the test data generated in step 1408 above is
 also based upon the physiological and/or non-physiological input signals.
 Similarly, step 1409 above includes the modification of the operation
 control signals and switching of control signals in response to both the
 electrical feedback signals and the physiological and/or non-physiological
 input signals.
 The preferred method depicted in FIG. 14 may optionally include the steps
 of monitoring the electrical feedback signals, the physiological input
 signals, the non-physiological input signals, or any combination thereof
 and downloading the test data to a test data receiver, for example, an
 external receiving device.
 While various embodiments of a method and device for treating
 oropharyngeal, respiratory, and oral motor neuromuscular disorders with
 electrical stimulation have been disclosed, it should be understood that
 modifications and adaptations thereof will occur to persons skilled in the
 art. Other features and aspects of this invention will be appreciated by
 those skilled in the art upon reading and comprehending this disclosure.
 Such features, aspects, and expected variations and modifications of the
 reported results and examples, as well as their equivalents, are clearly
 within the scope of the invention as described by the following claims.