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

Abstract

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.

We claim:  
     
         1 . An electrical neuromuscular stimulator for treating respiratory disorders comprising: 
 at least one electrode adapted for selective placement in electrical contact with tissue of at least one intercostal region of a patient: and    a pulse generator coupled to said at least one electrode for generating a series of electrical pulses, wherein said pulse generator comprises 
 a frequency controller for modulating an electrical signal generated by the pulse generator at a predetermined frequency to produce the series of electrical pulses output by said pulse generator,  
 a duration control circuit for controlling the duration of time for which said pulse generator outputs the series of electrical pulses, and  
 an intensity control circuit for regulating the series electrical pulses such that the electrical current does not exceed a predetermined current or voltage value.  
   
     
     
         2 . The electrical neuromuscular stimulator according to  claim 1 , wherein said intensity control circuit regulates the series electrical pulses such that the electrical current does not exceed a predetermined current or voltage value.  
     
     
         3 . The electrical neuromuscular stimulator according to  claim 1 , wherein said predetermined current and voltage values vary in accordance with the patient's physical condition or tolerances.  
     
     
         4 . An electrical neuromuscular stimulator for treating respiratory disorders, comprising: 
 at least one pulse generator for generating a series of electrical pulses;    a processor coupled to said at least one pulse generator for outputting operation control signals to said at least one pulse generator;    a switching network coupled to said at least one pulse generator and said processor, said switching network receiving the series of electrical pulses from said at least one pulse generator and outputting, responsive to switching control signals from said processor, the series of electrical pulses; and    an electrode array coupled to said switching network for applying the series of electrical pulses to tissue of at least one intercostal region of a patient.    
     
     
         5 . The electrical neuromuscular stimulator according to  claim 4 , wherein said electrode array generates electrical feedback signals in response to neuromuscular stimulation of the patient, the electrical feedback signals being provided to said processor via said switching network.  
     
     
         6 . The electrical neuromuscular stimulator according to  claim 5 , wherein, in response to the electrical feedback signals, said processor generates and stores test data.  
     
     
         7 . The electrical neuromuscular stimulator according to  claim 4 , wherein said switching network includes a buffer memory.  
     
     
         8 . The electrical neuromuscular stimulator according to  claim 5 , further comprising at least one physiological input device for providing physiological input signals to said processor, wherein said processor is responsive to the physiological inputs signals.  
     
     
         9 . The electrical neuromuscular stimulator according to  claim 5 , further comprising at least one non-physiological input device for providing non-physiological input signals to said processor, wherein said processor is responsive to the non-physiological inputs signals.  
     
     
         10 . The electrical neuromuscular stimulator according to  claim 5 , further comprising a programming device coupled to said processor.  
     
     
         11 . The electrical neuromuscular stimulator according to  claim 8 , further comprising a display device coupled to said processor.  
     
     
         12 . The electrical neuromuscular stimulator according to  claim 4 , further comprising a data/software interface device coupled to said processor.  
     
     
         13 . The electrical neuromuscular stimulator according to  claim 4 , wherein said electrode array comprises at least one bi-directional electrode.  
     
     
         14 . The electrical neuromuscular stimulator according to  claim 4 , wherein said electrode array comprises at least one unidirectional electrode.  
     
     
         15 . A method of electrical neuromuscular stimulation for treating respiratory disorders, comprising the steps of: 
 generating a series of electrical pulses using a pulse generator comprising: 
 a frequency controller for modulating an electrical signal generated by the pulse generator at a predetermined frequency to produce the series of electrical pulses output by said pulse generator,  
 a duration control circuit for controlling the duration of time for which said pulse generator outputs the series of electrical pulses, and  
 an intensity control circuit for regulating the series electrical pulses such that the electrical current does not exceed a predetermined current or voltage value; and  
   applying the series of electrical pulses to tissue of at least one intercostal region of a patient using an electrode array.    
     
     
         16 . A method of electrical neuromuscular stimulation for treating respiratory disorders, comprising the steps of: 
 generating a series of electrical pulses using at least one pulse generator;    generating operation control signals to control operation of said at least one pulse generator;    receiving the series of electrical pulses from said at least one pulse generator at a switching network;    generating switching control signals to control operation of said switching network;    outputting the series of electrical pulses from said switching network in accordance with said switching control signals;    applying the series of electrical pulses to tissue of a least one intercostal region of a patient using an electrode array;    generating electrical feedback signals in response to the application of the series of electrical pulses;    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.    
     
     
         17 . The method for electrical neuromuscular stimulation according to  claim 16 , further comprising the step of generating physiological input signals using at least one physiological input device; wherein the test data is generated in response to the electrical feedback signals and the physiological input signals; and wherein the operation control signals and switching control signals are responsive to the electrical feedback signals and the physiological inputs signals.  
     
     
         18 . The method for electrical neuromuscular stimulation according to  claim 16 , further comprising the step of generating non-physiological input signals using at least one non-physiological input device; wherein the test data is generated in response to the electrical feedback signals and the non-physiological input signals; and wherein the operation control signals and switching control signals are responsive to the electrical feedback signals and the non-physiological inputs signals.  
     
     
         19 . The method for electrical neuromuscular stimulation according to  claim 17 , further comprising the step of monitoring of the electrical feedback signals and the physiological input signals.  
     
     
         20 . The method for electrical neuromuscular stimulation according to  claim 18 , further comprising the step of monitoring of the electrical feedback signals and the non-physiological input signals.  
     
     
         21 . The method for electrical neuromuscular stimulation according to  claim 16 , further comprising the step of downloading the test data to a test data receiving device.  
     
     
         22 . An electrical neuromuscular stimulator for treating oral motor neuromuscular disorders, comprising: 
 at least one electrode adapted to be selectively placed in electrical contact with tissue of an oral motor region of a patient; and    a pulse generator for generating a series of electrical pulses in electrical contact with said at least one electrode, wherein said pulse generator comprises 
 a frequency controller for modulating an electrical signal generated by the pulse generator at a predetermined frequency to produce the series of electrical pulses output by said pulse generator,  
 a duration control circuit for controlling the duration of time for which said pulse generator outputs the series of electrical pulses, and  
 an intensity control circuit for regulating the series electrical pulses such that the electrical current does not exceed a predetermined current or voltage value.  
   
     
     
         23 . The electrical neuromuscular stimulator according to  claim 22 , wherein said predetermined current and voltage values vary in accordance with the patient's physical condition or tolerances.  
     
     
         24 . An electrical neuromuscular stimulator for treating oral motor neuromuscular disorders, comprising: 
 at least one pulse generator for generating a series of electrical pulses;    a processor coupled to said at least one pulse generator for outputting operation control signals to said at least one pulse generator;    a switching network coupled to said at least one pulse generator and said processor, said switching network receiving the series of electrical pulses from said at least one pulse generator and outputting, responsive to switching control signals from said processor, the series of electrical pulses; and    an electrode array coupled to said switching network for applying the series of electrical pulses to tissue of an oral motor region of a patient.    
     
     
         25 . The electrical neuromuscular stimulator according to  claim 24 , wherein said electrode array generates electrical feedback signals in response to the neuromuscular stimulation of the patient, the electrical feedback signals being provided to said processor via said switching network.  
     
     
         26 . The electrical neuromuscular stimulator according to  claim 25 , wherein, in response to the electrical feedback signals, said processor generates and stores test data.  
     
     
         27 . The electrical neuromuscular stimulator according to  claim 24 , wherein said switching network includes a buffer memory.  
     
     
         28 . The electrical neuromuscular stimulator according to  claim 25 , further comprising at least one physiological input device for providing physiological input signals to said processor, wherein said processor is responsive to the physiological inputs signals.  
     
     
         29 . The electrical neuromuscular stimulator according to  claim 25 , further comprising at least one non-physiological input device for providing non-physiological input signals to said processor, wherein said processor is responsive to the non-physiological inputs signals.  
     
     
         30 . The electrical neuromuscular stimulator according to  claim 25 , further comprising a programming device coupled to said processor for transmitting programming information and data to said processor.  
     
     
         31 . The electrical neuromuscular stimulator according to  claim 28 , further comprising a display device coupled to said processor for monitoring at least one of the electrical feedback signals, physiological input signals, test data, and operating status of said neuromuscular stimulator.  
     
     
         32 . The electrical neuromuscular stimulator according to  claim 28 , further comprising a display device coupled to said processor for monitoring at least one of the electrical feedback signals, non-physiological input signals, test data, and operating status of said neuromuscular stimulator.  
     
     
         33 . The electrical neuromuscular stimulator according to  claim 24 , further comprising a data/software interface device coupled to said processor for transmitting the test data.  
     
     
         34 . The electrical neuromuscular stimulator according to  claim 24 , wherein said electrode array comprises at least one bi-directional electrode.  
     
     
         35 . The electrical neuromuscular stimulator according to  claim 24 , wherein said electrode array comprises at least one unidirectional electrode.  
     
     
         36 . A method of electrical neuromuscular stimulation for treating oral motor neuromuscular disorders, comprising the steps of: 
 generating a series of electrical pulses using a pulse generator comprising: 
 a frequency controller for modulating an electrical signal generated by the pulse generator at a predetermined frequency to produce the series of electrical pulses output by said pulse generator,  
 a duration control circuit for controlling the duration of time for which said pulse generator outputs the series of electrical pulses, and  
 an intensity control circuit for regulating the series electrical pulses such that the electrical current does not exceed a predetermined current or voltage value; and  
   applying the series of electrical pulses to tissue of an oral motor region of a patient using an electrode array.    
     
     
         37 . A method of electrical neuromuscular stimulation for treating oral motor neuromuscular disorders, comprising the steps of: 
 generating a series of electrical pulses using at least one pulse generator;    generating operation control signals to control operation of said at least one pulse generator;    receiving the series of electrical pulses from said at least one pulse generator at a switching network;    generating switching control signals to control operation of said switching network;    outputting the series of electrical pulses from said switching network in accordance with said switching control signals;    applying the series of electrical pulses to tissue of an oral motor region of a patient using an electrode array;    generating electrical feedback signals in response to the application of the series of electrical pulses;    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.    
     
     
         38 . The method for electrical neuromuscular stimulation according to  claim 37 , further comprising the step of generating physiological input signals using at least one physiological input device; wherein the test data is generated in response to the electrical feedback signals and the physiological input signals; and wherein the operation control signals and switching control signals are responsive to the electrical feedback signals and the physiological inputs signals.  
     
     
         39 . The method for electrical neuromuscular stimulation according to  claim 37 , further comprising the step of generating non-physiological input signals using at least one non-physiological input device; wherein the test data is generated in response to the electrical feedback signals and the non-physiological input signals; and wherein the operation control signals and switching control signals are responsive to the electrical feedback signals and the non-physiological inputs signals.  
     
     
         40 . The method for electrical neuromuscular stimulation according to  claim 38 , further comprising the step of monitoring of the electrical feedback signals and the physiological input signals.  
     
     
         41 . The method for electrical neuromuscular stimulation according to  claim 39 , further comprising the step of monitoring of the electrical feedback signals and the non-physiological input signals.  
     
     
         42 . The method for electrical neuromuscular stimulation according to  claim 37 , further comprising the step of downloading the test data to a test data receiving device.