Method and apparatus for treating dysphagia with electrical stimulation

• US 5,725,564 A
• Filed: 10/27/1995
• Issued: 03/10/1998
• 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:
  US08/549,046
• Time in Patent Office: 865 Days
• Field of Search: 607/39, 607/40, 607/62, 607/72, 607/118
• 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 1/36034 specified by the stimulation parameters

Abstract

This invention is directed to a simple, non-invasive method and device for treating dysphagia and artificially promoting swallowing by electrical stimulus. In the present invention, a plurality of electrodes are selectively placed in electrical contact with tissue of a pharyngeal region of patient and a series of electrical pulses in electrical contact with each of the plurality of electrodes with a generator. The generator includes a pulse rate modulator for generating each of the electrical pulses having a frequency generally fixed at 80 hertz, a pulse width modulator for generating each pulse of the series of electrical pulses at a duration generally fixed at 300 microseconds, and a governor for regulating the electrical pulses such that at least one of current so as not to exceed 4.4 milliamps RMS or power so as not to exceed 9.6 MW RMS. The electrical pulses selectively stimulate muscles located proximate to the selectively placed electrodes to initiate swallowing.

Claims

1. An electrical pharyngeal neuromuscular stimulator comprising:

a plurality of electrodes adapted to be selectively placed in electrical contact with tissue of a pharyngeal region of an associated animal;

a generator for generating a series of electrical pulses in electrical contact with each of the plurality of electrodes, the generator including,

a pulse rate modulator for generating each of the electrical pulses having a frequency generally fixed at 80 hertz,

a pulse width modulator for generating each pulse of the series of electrical pulses at a duration generally fixed at 300 microseconds, and

a governor for regulating the electrical pulses such that at least one of current so as not to exceed 4.4 milliamps RMS or power so as not to exceed 9.6 MW RMS.

2. The electrical pharyngeal neuromuscular stimulator apparatus for artificially promoting swallowing of claim 1 wherein the generator for generating the series of electrical pulses includes means for increasing incrementally the electrical current value applied to the electrodes.

3. The electrical pharyngeal neuromuscular stimulator apparatus of claim 1 wherein the generator further includes a ramp function to increase the current of the pulses linearly as a function of time.

4. The electrical pharyngeal neuromuscular stimulator apparatus for artificially promoting swallowing of claim 1 wherein the generator for generating the series of electrical pulses includes means for generating a plurality of discrete cycles each of which includes a series of electrical pulses.

5. The electrical pharyngeal neuromuscular stimulator apparatus for artificially promoting swallowing of claim 4 wherein the means for generating the plurality of discrete cycles of the series of electrical pulses includes means for generating cycles of pulses up to 30 seconds in length.

6. The electrical pharyngeal neuromuscular stimulator apparatus for artificially promoting swallowing of claim 5 wherein the means for generating the plurality of cycles of the series of electrical pulses includes means for providing an off period wherein no pulses are generated, the off period being between the plurality of cycles of the series of electrical pulses.

7. A method for electrical pharyngeal neuromuscular stimulation for artificially promoting swallowing, said method comprising the steps of:

selectively placing a plurality of electrodes in electrical contact with tissue of a pharyngeal region of an associated animal; and

generating a series of electrical pulses in electrical contact with each of the plurality of electrodes with a generator, the generator including,

a pulse rate modulator for generating each of the electrical pulses having a frequency generally fixed at 80 hertz,

a pulse width modulator for generating each pulse of the series of electrical pulses at a duration generally fixed at 300 microseconds, and

a governor for regulating the electrical pulses such that at least one of current so as not to exceed 4.4 milliamps RMS or power so as not to exceed 9.6 MW RMS;

wherein the electrical pulses selectively stimulate muscles located proximate to the selectively placed electrodes to initiate swallowing.

8. The method of electrical pharyngeal neuromuscular stimulation for artificially promoting swallowing of claim 7 wherein the step of generating the series of electrical pulses includes increasing incrementally the electrical current value applied to the electrodes.

9. The method of electrical pharyngeal neuromuscular stimulation for artificially promoting swallowing of claim 7 wherein the step of generating the series of electrical pulses includes generating a plurality of cycles of the series of electrical pulses.

10. The method of electrical pharyngeal neuromuscular stimulation for artificially promoting swallowing of claim 9 wherein the step of generating the plurality of cycles of the series of electrical pulses includes generating cycles having pulses up to 30 seconds in duration.

11. The method of electrical pharyngeal neuromuscular stimulation for artificially promoting swallowing of claim 10 wherein the step of generating the plurality of cycles of the series of electrical pulses includes providing an off period wherein no pulses are generated, the off period being situated between the plurality of cycles of the series of electrical pulses.

12. The method of electrical pharyngeal neuromuscular stimulation for artificially promoting swallowing of claim 11 wherein the step of providing an off period between the plurality of cycles of the series of electrical pulses includes providing off periods up to 60 seconds in length.

13. The method of electrical pharyngeal neuromuscular stimulation for artificially promoting swallowing of claim 9 wherein the step of generating a series of electrical pulses further includes the step of increasing a magnitude of the pulses in the series of electrical pulses as a function of time.

14. The method of electrical pharyngeal neuromuscular stimulation for artificially promoting swallowing of claim 13 wherein the step of increasing a magnitude of the pluses increases the current value linearly over a selected duration.

15. The method of electrical pharyngeal neuromuscular stimulation for artificially promoting swallowing of claim 13 wherein the step of increasing a magnitude of the pulses as a function of time comprises increasing the electrical current value over a duration of up to 6 seconds.

16. The method of electrical pharyngeal neuromuscular stimulation for artificially promoting swallowing of claim 9 wherein the step of generating a series of electrical pulses further includes the step of decreasing a magnitude of the pulses in the series of electrical pulses as a function of time.

17. The method of electrical pharyngeal neuromuscular stimulation for artificially promoting swallowing of claim 16 wherein the step of decreasing a magnitude of the pulses includes decreasing a current value thereof generally linearly.

18. The method of electrical pharyngeal neuromuscular stimulation for artificially promoting swallowing of claim 16 wherein the step of decreasing a magnitude of the pulses as a function of time includes the step of decreasing the electrical current value over a duration of up to 6 seconds.

19. The method of electrical pharyngeal neuromuscular stimulation for artificially promoting swallowing of claim 7 wherein the step of selectively placing the plurality of electrodes includes operatively placing a first electrode at approximately the position of a lesser horn of a hyoid bone and operatively placing a second electrode at approximately the position of a lesser horn of a hyoid bone, the first and second electrodes placed substantially symmetrically on opposite sides of a generally longitudinal axis of the pharyngeal region.

20. The method of electrical pharyngeal neuromuscular stimulation for artificially promoting swallowing of claim 7 wherein the step of selectively placing the plurality of electrodes includes operatively placing a first electrode at approximately the position of a thyrohyoid membrane overlying a sternothyroid muscle and operatively placing a second electrode at approximately a cricoid cartilage overlying the sternothyroid muscle.

21. The method of electrical pharyngeal neuromuscular stimulation for artificially promoting swallowing of claim 7 wherein the step of selectively placing the plurality of electrodes includes operatively placing a first electrode at the position of a thyrohyoid membrane and operatively placing a second electrode at the position of the thyrohyoid membrane, the first and second electrodes placed substantially metrically on opposite sides of a generally longitudinal axis of the pharyngeal region.

22. The method of electrical pharyngeal neuromuscular stimulation for artificially promoting swallowing of claim 7 wherein the step of selectively placing the plurality of electrodes includes operatively placing a first electrode at a position between a thyrohyoid notch and a cricoid cartilage and operatively placing a second electrode at a position between a thyrohyoid notch and a cricoid cartilage, the first and second electrodes placed substantially symmetrically on opposite sides of a generally longitudinal axis of the pharyngeal region.

23. The method of electrical pharyngeal neuromuscular stimulation for artificially promoting swallowing of claim 7 wherein the step of selectively placing the plurality of electrodes includes operatively placing a first electrode at a position lateral to a lesser horn of a hyoid bone between the hyoid bone and a mandible and operatively placing a second electrode at an end of a thyrohyoid membrane.

24. The method of electrical pharyngeal neuromuscular stimulation for artificially promoting swallowing of claim 7 wherein the step of selectively placing the plurality of electrodes includes operatively placing a first electrode at a chin and generally on a longitudinal axis of the pharyngeal region and operatively placing a second electrode in the pharyngeal region generally radially off of the longitudinal axis of the pharyngeal region.

25. The method of electrical pharyngeal neuromuscular stimulation for artificially promoting swallowing of claim 7 wherein the series of electrical pulses are provided continuously.