Trans-esophageal vagus nerve stimulation

• US 7,904,175 B2
• Filed: 04/26/2007
• Issued: 03/08/2011
• 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:
  US11/796,058
• Publication Number:
  US 20080269833A1
• Time in Patent Office: 1,412 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 method of providing electrical signal therapy to a vagus nerve of a patient comprising:

using an ambulatory medical device to apply an electrical signal trans-esophageally to a vagus nerve of the patient from inside the abdominal portion of an esophagus;

the ambulatory medical device comprises at least one electrode; and

the operation of using the ambulatory medical device to apply an electrical signal trans-esophageally to the vagus nerve of the patient comprises applying said electrical signal to at least one vagus nerve of the patient through the wall of the esophagus to treat a medical condition of the patient, wherein said at least one electrode penetrates the wall of the esophagus.

2. A method according to claim 1, wherein:

the method further comprises implanting the ambulatory medical device in the lumen of the abdominal portion of the esophagus of the patient such that the at least one electrode is in contact with the surface of the esophagus wall.

3. The method of claim 2 wherein the ambulatory medical device comprises a support member having an outer surface, wherein the at least one electrode is disposed on the outer surface of the support member.

4. The method of claim 2 wherein implanting the ambulatory medical device comprises non-surgically coupling the ambulatory medical device to the inner surface of the esophagus wall.

5. The method of claim 2, where implanting the ambulatory medical device comprises introducing the ambulatory medical device into the patient'"'"'s mouth, passing the ambulatory medical device through the patient'"'"'s throat into the esophagus, placing the ambulatory medical device in the abdominal portion of the esophagus, and securing the ambulatory medical device to the wall of the abdominal portion of the esophagus.

6. The method of claim 5, wherein implanting the ambulatory medical device further comprises providing the ambulatory medical device in a contracted position prior to introducing the ambulatory medical device into the patient'"'"'s mouth, and expanding the ambulatory medical device into an expanded position prior to securing the ambulatory medical device to the wall of the lower esophagus.

7. The method of claim 6 wherein providing the ambulatory medical device comprises providing the ambulatory medical device mounted on a catheter.

8. The method of claim 7 wherein providing the ambulatory medical device comprises providing the ambulatory medical device mounted on a balloon catheter, and wherein implanting the ambulatory medical device comprises expanding the balloon portion of the balloon catheter to expand the ambulatory medical device to the expanded position.

9. The method of claim 2 wherein applying the electrical signal comprises selecting at least one parameter selected from the group consisting of pulse width, current amplitude, frequency, on-off time, duty cycle, number of pulses per burst, interburst period, interpulse interval, and burst duration.

10. The method of claim 2 wherein the method is used to treat a medical condition selected from the group consisting of epilepsy, neuropsychiatric disorders including depression, eating disorders, obesity, traumatic brain injury, coma, addiction disorders, dementia, sleep disorders, pain, migraine, pancreatic disorders including diabetes, motility disorders, hypertension, congestive heart failure, cardiac capillary growth, hearing disorders, angina, syncope, vocal cord disorders, thyroid disorders, pulmonary disorders, and reproductive endocrine disorders including fertility.

11. The method of claim 1 wherein the ambulatory medical device comprises a support member having an outer surface, wherein said at least one electrode is disposed on the outer surface of the support member.

12. The method of claim 1 wherein the ambulatory medical device is a wireless device.

13. The method of claim 11 wherein the ambulatory medical device comprises a signal generator and a power supply coupled to the at least one electrode.

14. The method of claim 13 wherein said signal generator and said power supply are integrated into the support member.

15. The method of claim 1 further comprising:

providing a portable external programming system capable of programming the ambulatory medical device; and

programming said ambulatory medical device using said portable external programming system.

16. The method of claim 1 further comprising non-surgically implanting the ambulatory medical device.

17. The method of claim 1 wherein the method is used to treat a medical condition selected from the group consisting of epilepsy, neuropsychiatric disorders including depression, eating disorders, obesity, traumatic brain injury, coma, addiction disorders, dementia, sleep disorders, pain, migraine, pancreatic disorders including diabetes, motility disorders, hypertension, congestive heart failure, cardiac capillary growth, hearing disorders, angina, syncope, vocal cord disorders, thyroid disorders, pulmonary disorders, and reproductive endocrine disorders including fertility.

18. A method according to claim 1, wherein:

said ambulatory medical device comprises;

a support member having an outer surface,

wherein the at least one electrode is on the outer surface of said support member; and

an electrical signal generator coupled to said support member and to said at least one electrode;

the method further comprises non-surgically implanting said ambulatory medical device;

and

the operation of using said ambulatory medical device to apply an electrical signal trans-esophageally to the vagus nerve of the patient comprises;

generating a therapeutic electrical signal using said electrical signal generator; and

applying said therapeutic electrical signal trans-esophageally to the vagus nerve of the patient from inside the abdominal portion of the patient'"'"'s esophagus.

19. The method of claim 18 further comprising:

providing a power supply coupled to said electrical signal generator.

20. The method of claim 18 wherein said step of applying said therapeutic electrical signal comprises treating a medical condition selected from the group consisting of epilepsy, neuropsychiatric disorders including depression, eating disorders, obesity, traumatic brain injury, coma, addiction disorders, dementia, sleep disorders, pain, migraine, pancreatic disorders including diabetes, motility disorders, hypertension, congestive heart failure, cardiac capillary growth, hearing disorders, angina, syncope, vocal cord disorders, thyroid disorders, pulmonary disorders, and reproductive endocrine disorders including fertility.