Method and apparatus for assisting deglutition

• US 7,890,178 B2
• Filed: 12/15/2006
• Issued: 02/15/2011
• 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.
• Primary Examiner(s): Bertram; Eric D.
• Application Number:
  US11/611,365
• Publication Number:
  US 20080147141A1
• Time in Patent Office: 1,523 Days
• Field of Search: 607/48, 607/42
• 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 of controlling deglutition of a user without substantial aspiration comprising:

subcutaneously positioning a first electrode array at a first location along a first nerve comprising a first fascicle controlling a first deglutition muscle and a second fascicle controlling a second deglutition muscle,

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

selectively stimulating the first fascicle with the first electrode array to artificially activate the first deglutition muscle independent of activation of the second deglutition muscle;

wherein the first deglutition muscle is selected from the group consisting of tongue, hyoglossus, genioglossus, constrictor pharyngis, cricopharyngeous, digastricus, cricoarytenoid laterlis, geniohyoid, levator veli palatini, mylohyoid, omohyoid, palatoglossus, palatopharyngeus, sternohyoid, sternothyroid, styoglossus, stylohoid, stylopharyngeus, and tensor veli palatine muscles;

selectively stimulating the second fascicle with the first electrode array to artificially activate the second deglutition muscle independent of activation of the first deglutition muscle; and

wherein only fascicles of the first nerve are artificially stimulated throughout user deglutition.

2. The method of claim 1, 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 and hyoglossus muscles of the user.

3. The method of claim 1, wherein the first nerve causes artificial activation of the first deglutition muscle via sensory activation of the first deglutition muscle.

4. The method of claim 1, 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 simultaneously providing subthreshold currents through the plurality of radially positioned contacts of the electrode array for steering a stimulation signal delivered to the first fascicle.

5. The method of claim 1, wherein the first nerve comprises a first fascicle controlling the first deglutition muscle, the method further comprising:

partially depolarizing the first nerve after stimulating the first fascicle.

6. The method of claim 5, wherein partially depolarizing the first nerve comprises stimulating the first nerve with a subthreshold rectangular pulse.

7. The method of claim 1, 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.

8. The method of claim 1, 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.

9. A system for assisting user deglutition comprising:

an electrode array adapted to be subcutaneously implanted to stimulate a first nerve comprising a first fascicle and a second fascicle, the first fascicle causing activation of a first deglutition muscle and the second fascicle causing activation of a second deglutition muscle, the electrode array including a plurality of electrode contacts;

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 programmed to operate the signal generator to selectively stimulate the first fascicle with the electrode array to cause activation of the first deglutition muscle independent of activation of the second deglutition muscle and selectively stimulate the second fascicle with the electrode array to cause activation of the second deglutition muscle independent of activation of the first deglutition muscle, including the controller programmed to simultaneously deliver varying amounts of energy to each of the plurality of electrode contacts as subthreshold steering currents configured to direct an additional stimulating current pulse to a selected region of the first nerve.

10. The system of claim 9, wherein the signal generator and the electrode array are housed together as a single unit adapted to be subcutaneously implanted.