METHOD AND APPARATUS FOR ASSISTING DEGLUTITION

• US 20080147141A1
• Filed: 12/15/2006
• Published: 06/19/2008
• Est. Priority Date: 12/15/2006
• Status: Active Grant

• Current Assignee: Medtronic Xomed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Xomed Incorporated (Medtronic Plc)
• Inventors: Jagler, Robyn Lee, Torgerson, Nathan Andrew, Hissong, James Britton, Davis, Jon P., Testerman, Roy L.
• Granted Patent: US 7,890,178 B2
• Time in Patent Office: Days
• US Class Current: 607/48
• CPC Class Codes: A61N 1/04 Electrodes electrosurgical electrodes A61B18/14
• CPC Class Codes: A61N 1/0504 Subcutaneous electrodes
• CPC Class Codes: A61N 1/0526 Head electrodes A61N1/0551 takes precedence
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36085 Eating disorders or obesity

Abstract

Artificially stimulated deglutition methods and systems including providing a portable system born by a user for controlling a component of a complete swallowing act without substantial aspiration. The system includes a controller, a signal generator, and a subcutaneously positioned electrode array with at least one electrode. The electrode array is subcutaneously positioned and is operated to stimulate a single deglutition muscle where the single deglutition muscle is the only deglutition muscle directly artificially stimulated via the electrode array during the complete swallowing act. Systems and methods of nerve stimulation and selective nerve stimulation are also provided to artificially stimulate deglutition.

Claims

1. A method for stimulating multiple deglutition responses in a user, the method comprising:

providing a portable system born by a user for controlling a component of a complete swallowing act without substantial aspiration, the system comprising a controller, a signal generator, and an electrode array including at least one electrode;

subcutaneously positioning the electrode array in stimulating communication with at least one deglutition muscle; and

artificially stimulating a single deglutition muscle to cause the component of the complete swallowing act to occur;

wherein the single deglutition muscle is the only deglutition muscle directly artificially stimulated via the electrode array during the complete swallowing act.

2. The method of claim 1, wherein the single deglutition muscle is artificially stimulated via stimulation of a nerve.

3. The method of claim 2, wherein the electrode array includes a nerve cuff electrode.

4. The method of claim 1, wherein the electrode array includes a self-contained electrode.

5. The method of claim 1, wherein the electrode array includes an electrode selected from the group consisting of an epimysial electrode and an intramuscular electrode.

6. The method of claim 1, wherein the single deglutition muscle is selected from the group consisting of a hyoglossus, a posterior belly of a digastric, and a stylohyoid of the user.

7. The method of claim 1, wherein the user is characterized as being capable of completing the complete swallowing act without substantial aspiration by autonomously, sufficiently stretching an upper esophageal sphincter of the user in combination with the artificially stimulated component of the complete swallowing act.

8. The method of claim 1, wherein artificially stimulating the single muscle to cause the component of the complete swallowing act to occur includes causing a hyolaryngeal complex of the user to lift.

9. A system for assisting user deglutition by only stimulating a single deglutition muscle, the system comprising:

an electrode array adapted to be subcutaneously implanted to stimulate the single deglutition muscle;

a signal generator adapted to communicate with the electrode array to stimulate the single deglutition muscle; and

a controller for operating the signal generator, wherein the controller is adapted to operate the signal generator to only directly stimulate the single deglutition muscle with the electrode array.

10. A method of controlling deglutition of a user without substantial aspiration comprising:

subcutaneously positioning a first electrode array at a first location along a first nerve, wherein the electrode array comprises at least one electrode, and further wherein the first nerve is associated with a first deglutition muscle such that stimulation of the first nerve causes movement of the first deglutition muscle; and

selectively stimulating the first nerve with the first electrode array to artificially activate the first deglutition muscle.

11. The method of claim 10, wherein the first nerve comprises a first fascicle controlling the first deglutition muscle and a second fascicle controlling a second deglutition muscle different from the first deglutition muscle, the method further comprising:

selectively stimulating the second fascicle with the first electrode array to artificially activate the second deglutition muscle.

12. The method of claim 11, wherein the first nerve is a hypoglossal nerve and further wherein each of the first and second deglutition muscles are selected from the group consisting of geniohyoid, hyoglossus, and thyrohyoid muscles of the user.

13. The method of claim 11, wherein only fascicles of the first nerve are artificially stimulated throughout user deglutition.

14. The method of claim 10, wherein the first nerve causes artificial activation of the first deglutition muscle via sensory activation of the first deglutition muscle.

16. The method of claim 10, further comprising:

partially depolarizing the first nerve after stimulating the first fascicle.

17. The method of claim 16, wherein partially depolarizing the first nerve comprises stimulating the first nerve with a subthreshold rectangular pulse.

18. The method of claim 10, further comprising:

subcutaneously positioning the electrode array in stimulating communication with a mylohyoid, a genihyoid, and a thyrohyoid and at least one of an anterior belly of a digastric and a hyoglossus of the user.

19. The method of claim 10, wherein the electrode array includes an electrode selected from the group consisting of a self-contained electrode, an intramuscular electrode, an epimysial electrode, and a nerve cuff.

15. The method of clam 10, wherein the electrode array comprises a plurality of radially positioned contacts disposed about the first nerve at the first location, and further wherein stimulating the first fascicle comprises providing subthreshold current through the electrode array for steering a stimulation signal delivered to the first fascicle.

20. A system for assisting user deglutition comprising:

an electrode array adapted to be subcutaneously implanted to stimulate a first nerve, the first nerve causing activation of a first deglutition muscle, the electrode array including at least one electrode;

a signal generator adapted to communicate with the electrode array to stimulate the first nerve; and

a controller for operating the signal generator, wherein the controller is adapted to operate the signal generator to stimulate the first nerve with the electrode array to cause activation of the first deglutition muscle.

21. The system of claim 20, wherein the first nerve includes a first fascicle controlling the first deglutition muscle and a second fascicle controlling a second deglutition muscle, and wherein the controller is further adapted to selectively stimulate the second fascicle with the electrode array.

22. The system of claim 20, wherein the signal generator and the electrode array are housed together as a single unit adapted to be subcutaneously implanted.