Method and apparatus for treating oropharyngeal disorders with electrical stimulation

• US 5,891,185 A
• Filed: 11/10/1997
• Issued: 04/06/1999
• 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., Asmar, Marie, Kotton, Bernard, Freed, Leonard A., Christian, Michael O., Beytas, Erol M.
• Primary Examiner(s): Getzow, Scott M.
• Application Number:
  US08/966,580
• Time in Patent Office: 512 Days
• Field of Search: 607/72, 607/39, 607/40, 607/62, 607/118, 607/63, 607/59
• US Class Current: 607/72
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system

Abstract

A simple, non-invasive device and method for treating oropharyngeal disorders provides electrical stimulation to the pharyngeal region of a patient. Oropharyngeal disorders may cause an inability to swallow or difficulty in swallowing. The method and device provide an effective and non-invasive treatment for these disorders which is substantially more effective than traditional treatment methods, such as thermal stimulation. The method and device also effectively treat worst-case dysphagia (the inability to swallow) resulting from neurodegeneration and strokes. The device, an electrical pharyngeal neuromuscular stimulator, includes one or more pulse generators for generating a series of electrical pulses and a processor coupled to the pulse generators for controlling their operation. A switching network is also coupled to the pulse generators. The switching network directs series of electrical pulses respectively generated by the pulse generators to an electrode array positioned on the tissue of a patient'"'"'s pharyngeal region. The processor controls the switching operation of the switching network by determining which electrode in the electrode array receives the series of pulses generated by the respective pulse generators. The electrode array also generates electrical feedback signals in response to the neuromuscular stimulation of the patient. The electrical feedback signals are 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.

Claims

1. An electrical pharyngeal neuromuscular stimulator 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 a pharyngeal 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.

2. The electrical pharyngeal neuromuscular stimulator according to claim 1, wherein said switching network includes a buffer memory.

3. The electrical pharyngeal neuromuscular stimulator according to claim 1, further comprising at least one physiological input device for providing physiological input signals to said processor, wherein said processor modifies the operation control signals and switching control signals in response to the physiological inputs signals.

4. The electrical pharyngeal neuromuscular stimulator according to claim 3, 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 pharyngeal neuromuscular stimulator.

5. The electrical pharyngeal neuromuscular stimulator according to claim 1, further comprising at least one non-physiological input device for providing non-physiological input signals to said processor, wherein said processor modifies the operation control signals and switching control signals in response to the non-physiological inputs signals.

6. The electrical pharyngeal neuromuscular stimulator according to claim 5, 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 pharyngeal neuromuscular stimulator.

7. The electrical pharyngeal neuromuscular stimulator according to claim 1, further comprising a programming device coupled to said processor for transmitting programming information and data to said processor.

8. The electrical pharyngeal neuromuscular stimulator according to claim 1, further comprising a data/software interface device coupled to said processor for transmitting the test data.

9. The electrical pharyngeal neuromuscular stimulator according to claim 1, wherein said electrode array comprises four bi-directional electrodes.

10. The electrical pharyngeal neuromuscular stimulator according to claim 1, wherein said electrode array comprises four uni-directional electrodes.

11. A method for electrical pharyngeal neuromuscular stimulation for artificially promoting swallowing, 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 pharyngeal 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.

12. The method for electrical pharyngeal neuromuscular stimulation according to claim 11, 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 modified in response to the electrical feedback signals and the physiological inputs signals.

13. The method for electrical pharyngeal neuromuscular stimulation according to claim 12, further comprising the step of monitoring of the electrical feedback signals and the physiological input signals.

14. The method for electrical pharyngeal neuromuscular stimulation according to claim 11, 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 modified in response to the electrical feedback signals and the non-physiological inputs signals.

15. The method for electrical pharyngeal neuromuscular stimulation according to claim 14, further comprising the step of monitoring of the electrical feedback signals and the non-physiological input signals.

16. The method for electrical pharyngeal neuromuscular stimulation according to claim 11, further comprising the step of downloading the test data to a test data receiving device.