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

• US 6,198,970 B1
• Filed: 01/25/1999
• Issued: 03/06/2001
• Est. Priority Date: 10/27/1995
• Status: Expired due to Term

• Current Assignee: ESD LLC
• Original Assignee: ESD LLC
• Inventors: Tucker, Howard, Freed, Marcy L.
• Primary Examiner(s): Getzow, Scott M.
• Application Number:
  US09/236,829
• Time in Patent Office: 771 Days
• Field of Search: 607/42, 607/47, 607/72, 607/73, 607/74
• US Class Current: 607/42
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: A61N 1/36031 using physiological parameters for adjustment
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters
• CPC Class Codes: A61N 1/37241 providing test stimulations

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.

Claims

1. A device for treating respiratory disorders using electrical stimulation, comprising:

a power source;

a signal generator for providing an output signal, said output signal having an intensity, a frequency, and a pulse duration;

an output protector circuit for limiting said intensity of said output signal;

a treatment duration circuit for controlling the duration of operation of said signal generator;

a ramp control circuit for controlling said intensity of said output signal; and

a monitor for displaying operating parameters of said device;

wherein said signal generator regulates said intensity, said frequency, and said pulse duration of said output signal in accordance with a procedure for treating respiratory disorders by applying said output signal to an intercostal region of a patient;

wherein said treatment duration circuit and said ramp control circuit regulate said output signal in accordance with a procedure for treating respiratory disorders by applying said output signal to the intercostal region of the patient; and

wherein said output protector circuit is programmed to limit said intensity of said output signal in accordance with a treatment tolerance level of the patient.

2. A device for treating respiratory disorders using electrical stimulation, comprising:

a power source;

a signal generator for providing an output signal, said output signal having an intensity, a frequency, and a pulse duration;

an output protector circuit for limiting said intensity of said output signal;

a treatment duration circuit for controlling the duration of operation of said signal generator;

a ramp control circuit for controlling said intensity of said output signal;

a monitor for displaying operating parameters of said device; and

at least one electrode for providing said output signal to an intercostal region of a patient;

wherein said signal generator regulates said intensity, said frequency, and said pulse duration of said output signal in accordance with a procedure for treating respiratory disorders by applying said output signal to the intercostal region of the patient;

wherein said treatment duration circuit and said ramp control circuit regulate said output signal in accordance with a procedure for treating respiratory disorders by applying said output signal to the intercostal region of the patient; and

wherein said output protector circuit is programmed to limit said intensity of said output signal in accordance with a treatment tolerance level of the patient.

3. 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 an intercostal region of a patient to achieve neuromuscular stimulation of the patient, and for generating electrical feedback signals in response to the neuromuscular stimulation of the patient,

wherein the electrical feedback signals are provided to said processor via said switching network, and

wherein, in response to the electrical feedback signals, said processor generates and stores test data and modifies the operation control signals and switching control signals.

4. The electrical neuromuscular stimulator according to claim 3, wherein said switching network includes a buffer memory.

5. The electrical neuromuscular stimulator according to claim 3, 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.

6. The electrical neuromuscular stimulator according to claim 5, further comprising a display device coupled to said processor.

7. The electrical neuromuscular stimulator according to claim 3, 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.

8. The electrical neuromuscular stimulator according to claim 3, further comprising a programming device coupled to said processor.

9. The electrical neuromuscular stimulator according to claim 3, further comprising a data/software interface device coupled to said processor.

10. The electrical neuromuscular stimulator according to claim 3, wherein said electrode array comprises at least one bi-directional electrode.

11. The electrical neuromuscular stimulator according to claim 3, wherein said electrode array comprises at least one uni-directional electrode.

12. A device for treating oral motor neuromuscular disorders using electrical stimulation, comprising:

a power source;

a signal generator for providing an output signal, said output signal having an intensity, a frequency, and a pulse duration;

an output protector circuit for limiting said intensity of said output signal;

a treatment duration circuit for controlling the duration of operation of said signal generator;

a ramp control circuit for controlling said intensity of said output signal; and

a monitor for displaying operating parameters of said device;

wherein said signal generator regulates said intensity, said frequency, and said pulse duration of said output signal in accordance with a procedure for treating oral motor neuromuscular disorders by applying said output signal to an oral motor region of a patient;

wherein said treatment duration circuit and said ramp control circuit regulate said output signal in accordance with a procedure for treating oral motor neuromuscular disorders by applying said output signal to the oral motor region of the patient; and

wherein said output protector circuit is programmed to limit said intensity of said output signal in accordance with a treatment tolerance level of the patient.

13. 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.

14. 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.

15. The method for electrical neuromuscular stimulation according to claim 14, 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.

16. The method for electrical neuromuscular stimulation according to claim 15, further comprising the step of monitoring of the electrical feedback signals and the physiological input signals.

17. The method for electrical neuromuscular stimulation according to claim 14, 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.

18. The method for electrical neuromuscular stimulation according to claim 17, further comprising the step of monitoring of the electrical feedback signals and the non-physiological input signals.

19. The method for electrical neuromuscular stimulation according to claim 14, further comprising the step of downloading the test data to a test data receiving device.

20. 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.

21. 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.

22. The method for electrical neuromuscular stimulation according to claim 21, 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.

23. The method for electrical neuromuscular stimulation according to claim 22, further comprising the step of monitoring of the electrical feedback signals and the physiological input signals.

24. The method for electrical neuromuscular stimulation according to claim 21, 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.

25. The method for electrical neuromuscular stimulation according to claim 24, further comprising the step of monitoring of the electrical feedback signals and the non-physiological input signals.

26. The method for electrical neuromuscular stimulation according to claim 21, further comprising the step of downloading the test data to a test data receiving device.

27. 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 to achieve neuromuscular stimulation of the patient, and for generating electrical feedback signals in response to the neuromuscular stimulation of the patient,

wherein the electrical feedback signals are provided to said processor via said switching network, and

wherein, in response to the electrical feedback signals, said processor generates and stores test data and modifies the operation control signals and switching control signals.

28. The electrical neuromuscular stimulator according to claim 27, wherein said switching network includes a buffer memory.

29. The electrical neuromuscular stimulator according to claim 27, 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.

30. The electrical neuromuscular stimulator according to claim 29, 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.

31. The electrical neuromuscular stimulator according to claim 29, 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.

32. The electrical neuromuscular stimulator according to claim 27, 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.

33. The electrical neuromuscular stimulator according to claim 27, further comprising a programming device coupled to said processor for transmitting programming information and data to said processor.

34. The electrical neuromuscular stimulator according to claim 27, further comprising a data/software interface device coupled to said processor for transmitting the test data.

35. The electrical neuromuscular stimulator according to claim 27, wherein said electrode array comprises at least one bidirectional electrode.

36. The electrical neuromuscular stimulator according to claim 27, wherein said electrode array comprises at least one uni-directional electrode.

37. A device for treating oral motor neuromuscular disorders using electrical stimulation, comprising:

a power source;

a signal generator for providing an output signal, said output signal having an intensity, a frequency, and a pulse duration;

an output protector circuit for limiting said intensity of said output signal;

a treatment duration circuit for controlling the duration of operation of said signal generator;

a ramp control circuit for controlling said intensity of said output signal;

a monitor for displaying operating parameters of said device; and

at least one electrode for providing said output signal to an oral motor region of a patient;

wherein said signal generator regulates said intensity, said frequency, and said pulse duration of said output signal in accordance with a procedure for treating oral motor neuromuscular disorders by applying said output signal to the oral motor region of the patient;

wherein said treatment duration circuit and said ramp control circuit regulate said output signal in accordance with a procedure for treating oral motor neuromuscular disorders by applying said output signal to the oral motor region of the patient; and

wherein said output protector circuit is programmed to limit said intensity of said output signal in accordance with a treatment tolerance level of the patient.