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

• US 7,869,884 B2
• Filed: 04/26/2007
• Issued: 01/11/2011
• Est. Priority Date: 04/26/2007
• Status: Expired due to Fees

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Scott, Timothy L., Maschino, Steven E.
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): Malamud; Deborah
• Application Number:
  US11/796,158
• Publication Number:
  US 20080269840A1
• Time in Patent Office: 1,356 Days
• Field of Search: 607 1- 2, 607/40, 607/59, 607115-116, 607/118, 607/133, 607/145
• US Class Current: 607/116
• 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

Devices and methods of non-surgically providing vagus nerve therapy trans-esophageally to treat a variety of medical conditions are disclosed herein. In an embodiment, an implantable medical device comprises a support member having an outer surface. The support member is adapted to engage the inner wall of an esophagus. The IMD also comprises at least one electrode disposed on the outer surface of the support member. The at least one electrode is capable of applying a trans-esophageal electrical signal to the vagus nerve through the wall of the esophagus from the inner lumen thereof. The implantable medical device further comprises a signal generator coupled to the support member and to the at least one electrode. The signal generator causes the at least one electrode to apply an electrical signal to the vagus nerve to treat a medical condition.

Claims

1. A medical device for providing a therapeutic electrical signal to a vagus nerve of a patient comprising:

a support member having an outer surface adapted to engage the inner surface of an esophagus;

at least one electrode disposed on the outer surface of said support member, said at least one electrode adapted to apply a trans-esophageal electrical signal to a vagus nerve of the patient through the wall of the esophagus, wherein said at least one electrode penetrates the wall of the esophagus;

one or more anchors to secure said support member to the inner surface of the esophagus, wherein said one or more anchors comprises said at least one electrode; and

a signal generator coupled to the support member and to the at least one electrode, wherein said signal generator generates said electrical signal for application to the vagus nerve.

2. The medical device of claim 1, wherein said support member has a contracted size and an expanded size.

3. The medical device of claim 1, wherein said support member comprises a stent.

4. The medical device of claim 1, wherein said support member comprises a planar, flexible member, a ring member, or a partial ring member.

5. The medical device of claim 1, wherein said support member comprises a polymer, a metal, or combinations thereof.

6. The medical device of claim 5, wherein said support member comprises a polymer selected from the group consisting of a silicone polymer, a hydrogel, polyethylene, polypropylene, polyurethane, polycaprolactone, polytetrafluoroethylene (PTFE), and combinations thereof.

7. The medical device of claim 1, further comprising a retainment member coupled to said support member.

8. The medical device of claim 7, wherein said retainment member is selected from the group consisting of a stent, a metallic ring, a metallic wire, a metallic mesh, a polymer ring, and a polymer mesh.

9. The medical device of claim 1, further comprising a power supply coupled to said signal generator.

10. The medical device of claim 1, comprising a plurality of electrodes.

11. The medical device of claim 10, wherein said plurality of electrodes are a plurality of parallel bands disposed around the outer surface of said support member.

12. The medical device of claim 1, wherein said one or more anchors comprise sutures, barbs, staples, adhesives, pins, or combinations thereof.

13. An implantable medical device comprising:

a support member having an outer surface operable to engage an inner surface of an esophagus of a patient;

at least one electrode coupled to said outer surface of the support member and operable to apply an electrical signal to a vagus nerve of the patient through the wall of the esophagus, wherein said at least one electrode penetrates the wall of the esophagus;

a signal generator coupled to the support member and to the at least one electrode, wherein said signal generator is capable of generating said electrical signal for application to a vagus nerve of the patient; and

a power supply coupled to said support member and to said signal generator, wherein said power supply is capable of providing electrical power to said signal generator.

14. The implantable medical device of claim 13 wherein at least a portion of said signal generator and said power supply are integral to said support member.

15. The implantable medical device of claim 14 wherein said at least a portion of said signal generator and said power supply are embedded within said support member.

16. The implantable medical device of claim 13 wherein said support member comprises at least one of:

a polymer selected from the group consisting of a silicone polymer, a hydrogel, polyethylene, polypropylene, polyurethane, polycaprolactone, polytetrafluoroethylene (PTFE), and combinations thereof; and

a metal.

17. The implantable medical device of claim 13 further comprising a retainment member coupled to said support member, said retainment member selected from the group consisting of a stent, a metallic ring, a metallic partial ring, a metallic wire, a metallic mesh, a polymer ring, a metallic partial ring, and a polymer mesh.

18. A medical device system comprising:

a support member having an outer surface that is adapted to engage an inner surface of an esophagus of a patient;

at least one electrode coupled to said outer surface of the support member and adapted to apply a therapeutic electrical signal trans-esophageally to a vagus nerve of a patient, wherein said at least one electrode penetrates the wall of the esophagus;

a signal generator coupled to the support member and to the at least one electrode, wherein said signal generator is capable of generating said electrical signal for application to a vagus nerve;

a power supply for providing electrical power to said signal generator; and

an external programming system for programming one or more parameters defining said therapeutic electrical signal.

19. The medical device system of claim 18 wherein said power supply is coupled wirelessly to said signal generator.

20. The medical device system of claim 18 wherein said at least one electrode, said signal generator, and said power supply are integrated into a unitary implantable medical device for implantation in the lower esophagus of the patient.

21. The medical device system of claim 18 wherein said support member comprises at least one of:

a polymer selected from the group consisting of a silicone polymer, a hydrogel, polyethylene, polypropylene, polyurethane, polycaprolactone, polytetrafluoroethylene (PTFE), and combinations thereof; and

a metal.

22. The medical device system of claim 18 wherein said external programming system comprises a programming device selected from the group consisting of a personal computer, a personal digital assistant, and a portable computing device.