Non-surgical device and methods for trans-esophageal vagus nerve stimulation

• US 7,962,214 B2
• Filed: 07/27/2007
• Issued: 06/14/2011
• Est. Priority Date: 04/26/2007
• Status: Active Grant

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Byerman, Bryan P., Scott, Timothy L., Maschino, Steven E.
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): MALAMUD, DEBORAH LESLIE
• Application Number:
  US11/829,772
• Publication Number:
  US 20080269834A1
• Time in Patent Office: 1,418 Days
• Field of Search: 607 1- 2, 607/40, 607/59, 607115-116, 607/118, 607/133, 607/145
• US Class Current: 607/40
• CPC Class Codes: A61N 1/0517 Esophageal electrodes
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362

Abstract

A method and apparatus for providing trans-esophageal electrical signal therapy to a portion of a vagus nerve of a patient to treat a medical condition. An implantable medical device comprising at least one electrode is implanted in an inner lumen of the esophagus of the patient. At least one electrode is electrically coupled to the inner lumen of the esophagus. An electrical signal from the IMD is provided to a target portion of the vagus nerve through at least a portion of the wall of the esophagus for treating the medical condition.

Claims

1. An implantable medical device (IMD) for providing a trans-esophageal electrical signal to a target portion of the vagus nerve, comprising:

a generally elongated outer shell comprising an upper surface configured in a generally convex shape, a lower surface opposite the upper surface, a leading end, and a trailing end opposite the leading end, wherein the leading end is substantially narrower than the trailing end, wherein the lower surface is configured in a generally flat shape for conforming to a portion of an inner wall of an esophagus of a patient, and wherein the outer shell is configured to be affixable to the inner wall of the esophagus with the substantially narrower leading end pointing up;

at least one electrode protruding from said outer shell and extending past the lower surface of the outer shell, said electrode capable of being electrically coupled to a portion of said inner wall of the esophagus of a patient;

a power supply to provide power for an operation performed by said IMD; and

a signal generation unit operatively coupled to said power supply and to said at least one electrode, said signal generation unit to generate said electrical signal to provide a therapeutic electrical signal to a vagus nerve through at least a portion of the wall of the esophagus of said patient.

2. The implantable medical device of claim 1, wherein said outer shell comprises at least one suture structure selected from the group consisting of a suture hole and a suture loop, to allow for suturing said IMD to said inner wall of the esophagus.

3. The implantable medical device of claim 1, wherein said at least one electrode is formed as a hook capable of penetrating said inner wall of the esophagus for securing said IMD on said inner wall of the esophagus.

4. The implantable medical device of claim 1, wherein said IMD further comprises a communication unit for receiving a programming signal from an external unit for defining said electrical signal.

5. The implantable medical device claim 1, wherein said IMD further comprises a controller to control an operation of said medical device, and a magnetic field detection unit to receive a magnetic signal from an external source.

6. The implantable medical device claim 1, wherein at least one of the leading and trailing ends comprises a framed end configured with a low profile, and wherein said at least one framed end comprises a mechanism for securing said IMD onto said portion of said inner wall of the esophagus.

7. The IMD of claim 1, wherein the outer shell has a shape that allows food to travel down the esophagus past the IMD without excessive obstruction when the IMD is affixed to the inner wall of the esophagus with the substantially narrower leading end pointing up.

8. The IMD of claim 1, wherein the outer shell is generally leech shaped.