Stimulator for auricular branch of vagus nerve

• US 9,089,691 B2
• Filed: 12/07/2004
• Issued: 07/28/2015
• Est. Priority Date: 12/07/2004
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Libbus, Imad, Moffitt, Julia
• Primary Examiner(s): Bertram, Eric D.
• Application Number:
  US11/005,703
• Publication Number:
  US 20060122675A1
• Time in Patent Office: 3,885 Days
• Field of Search: 607/17, 607/40, 607 45- 46, 600/382, 600/386, 600/379
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362

Abstract

Devices and methods to stimulate the auricular branch of the vagus nerve are provided. Various device embodiments comprise a lead, a neural stimulation circuit, and a controller. The lead has a neural stimulation electrode. The neural stimulation circuit is connected to the lead to deliver a neural stimulation signal adapted to stimulate the auricular nerve branch using the neural stimulation electrode. The controller is connected to the neural stimulation circuit and is adapted to control delivery of the neural stimulation signal from the neural stimulation circuit to provide a vagal stimulation therapy. In various embodiments, the electrode is adapted to be placed in an external auditory canal. In various embodiments, the electrode includes a transcutaneous neural stimulation electrode adapted to be placed behind an ear.

Claims

1. A device, comprising:

a lead with a neural stimulation electrode adapted to be placed past a conch of an outer ear into an external auditory canal to target an auricular nerve branch for neural stimulation, wherein the auricular nerve branch innervates surfaces of the outer ear and skin over a parotid gland and mastoid process near the outer ear, and wherein the neural stimulation electrode is configured to be appropriately placed within the external auditory canal effectively proximate to the outer ear near the auricular nerve branch to deliver stimulation from the external auditory canal out toward the auricular nerve branch;

a neural stimulation circuit connected to the lead to deliver a neural stimulation signal from the neural stimulation electrode appropriately placed within the external auditory canal out toward the auricular nerve branch, the neural stimulation circuit configured to deliver the neural stimulation signal with stimulation parameters effective to elicit depolarization of the auricular nerve branch from the appropriately placed neural stimulation electrode; and

a controller connected to the neural stimulation circuit and adapted to control delivery of the neural stimulation signal from the neural stimulation circuit to control depolarization of the auricular nerve branch, the controller configured to provide a vagal stimulation therapy using controlled depolarization of the auricular nerve branch.

2. The device of claim 1, further comprising a feedback circuit connected to the controller to provide the controller with a feedback signal indicative of a physiologic signal, the controller being adapted to respond to the feedback signal to adjust the neural stimulation signal delivered from the neural stimulation circuit.

3. The device of claim 2, wherein the feedback circuit includes a heart rate monitor to detect a heart rate, and the controller is adapted to adjust the neural stimulation delivered from the neural stimulation circuit based on the detected heart rate.

4. The device of claim 3, wherein the heart rate monitor includes a sensor to directly detect a heart rate from a carotid artery.

5. The device of claim 2, wherein the feedback circuit includes a blood pressure monitor to detect a blood pressure, and the controller is adapted to adjust the neural stimulation delivered from the neural stimulation circuit based on the detected blood pressure.

6. The device of claim 5, wherein the blood pressure monitor is adapted to sense blood pressure from a carotid artery.

7. The device of claim 2, wherein the feedback circuit includes an electrocardiogram (ECG) monitor to detect an ECG signal, and the controller is adapted to adjust the neural stimulation delivered from the neural stimulation circuit based on the detected ECG signal.

8. The device of claim 1, wherein the controller is adapted to respond to provide open-loop neural stimulation based on predetermined neural stimulation parameters.

9. The device of claim 8, wherein the open-loop neural stimulation includes intermittent neural stimulation.

10. The device of claim 8, wherein the open-loop neural stimulation includes periodic neural stimulation.

11. The device of claim 1, wherein the neural stimulation circuit and the controller are adapted to provide a post myocardial infarction therapy using the neural stimulation signal delivered by the neural stimulation circuit to depolarize the auricular branch of the vagus nerve.

12. The device of claim 1, wherein the neural stimulation circuit and the controller are adapted to provide angina therapy using the neural stimulation signal delivered by neural stimulation circuit to depolarize the auricular branch of the vagus nerve.

13. The device of claim 1, further comprising an actuator to allow a patient to initiate delivery of the neural stimulation signal.

14. The device of claim 13, wherein the actuator includes a switch to be actuated by a magnetic field such that the patient provides the magnetic field to actuate the switch and initiate delivery of the neural stimulation signal to the neural stimulation electrode.

15. A device, comprising:

a lead with a transcutaneous neural stimulation electrode to be placed behind an outer ear to target an auricular nerve branch with transcutaneous stimulation, wherein the auricular nerve branch innervates skin over a mastoid process behind the outer ear;

a neural stimulation circuit connected to the lead to deliver a neural stimulation signal adapted to stimulate the auricular nerve branch using the neural stimulation electrode;

a controller connected to the neural stimulation circuit and adapted to control delivery of the neural stimulation signal from the neural stimulation circuit to depolarize the auricular nerve branch to provide a vagal stimulation therapy; and

a feedback circuit connected to the controller to provide the controller with a feedback signal indicative of a physiologic signal, the controller being adapted to respond to the feedback signal to adjust the neural stimulation signal delivered from the neural stimulation circuit.

16. The device of claim 15, wherein the feedback circuit includes a heart rate monitor to detect a heart rate, and the controller is adapted to respond to adjust the neural stimulation delivered from the neural stimulation circuit based on the detected heart rate.

17. The device of claim 16, wherein the monitor includes a sensor to directly detect a heart rate from a carotid artery.

18. The device of claim 15, wherein the feedback circuit includes a blood pressure monitor to detect a blood pressure, and the controller is adapted to respond to adjust the neural stimulation delivered from the neural stimulation circuit based on the detected blood pressure.

19. The device of claim 18, wherein the blood pressure monitor is adapted to sense blood pressure from a carotid artery.

20. The device of claim 15, wherein the feedback circuit includes an electrocardiogram (ECG) monitor to detect an ECG signal, and the controller is adapted to adjust the neural stimulation delivered from the neural stimulation circuit based on the detected ECG signal.

21. The device of claim 15, wherein the controller is adapted to respond to provide open-loop neural stimulation based on predetermined neural stimulation parameters.

22. The device of claim 21, wherein the open-loop neural stimulation includes intermittent neural stimulation.

23. The device of claim 21, wherein the open-loop neural stimulation includes periodic neural stimulation.

24. The device of claim 15, wherein the neural stimulation circuit and the controller are adapted to provide a post myocardial infarction therapy using the neural stimulation signal delivered by the neural stimulation circuit to depolarize the auricular branch of the vagus nerve.

25. The device of claim 15, wherein the neural stimulation circuit and the controller are adapted to provide angina therapy using the neural stimulation signal delivered by the neural stimulation circuit to depolarize the auricular branch of the vagus nerve.

26. The device of claim 15, further comprising an actuator to allow a patient to initiate delivery of the neural stimulation signal.

27. The device of claim 26, wherein the actuator includes a switch to be actuated by a magnetic field such that the patient provides the magnetic field to actuate the switch and initiate delivery of the neural stimulation signal to the neural stimulation electrode.

28. A device, comprising:

at least one port to connect at least one lead, the at least one lead including at least one neural stimulation electrode and at least one physiology sensor;

a neural stimulation circuit connected to the at least one port to selectively deliver a neural stimulation signal to the neural stimulation electrode to target an auricular nerve branch for neural stimulation, wherein the auricular nerve branch innervates surfaces of an outer ear and skin over a parotid gland and mastoid process near the outer ear, and wherein the neural stimulation electrode is configured to be appropriately placed proximate the auricular nerve branch to deliver stimulation toward the auricular nerve branch;

a feedback circuit connected to the at least one port to receive a feedback signal from the at least one physiology sensor; and

a controller connected to the neural stimulation circuit and adapted to deliver the neural stimulation signal to the neural stimulation electrode, the controller further being connected to the feedback circuit and adapted to adjust the neural stimulation signal in response to the feedback signal.

29. The device of claim 28, wherein the feedback circuit includes a heart rate monitor to detect a heart rate, and the controller is adapted to adjust the neural stimulation based on the detected heart rate.

30. The device of claim 28, wherein the feedback circuit includes an electrocardiogram (ECG) monitor to detect an ECG signal, and the controller is adapted to adjust the neural stimulation based on the detected ECG signal.

31. The device of claim 28, wherein the feedback circuit includes a blood pressure monitor to detect a blood pressure, and the controller is adapted to respond to adjust the neural stimulation based on the detected blood pressure.

32. The device of claim 28, wherein the neural stimulation electrode includes a bipolar electrode adapted to be inserted into and appropriately placed within an external auditory canal proximate to the outer ear near the auricular nerve branch to stimulate the auricular nerve branch.

33. The device of claim 28, wherein the neural stimulation electrode includes a transcutaneous neural electrode adapted to be placed behind an ear to transcutaneously stimulate the auricular nerve branch.

34. The device of claim 33, wherein the transcutaneous neural electrode has a patch for adhering to skin.

35. The device of claim 28, wherein the neural stimulation electrode includes an electrode adapted to be pierced through skin to stimulate the auricular nerve branch.

36. The device of claim 28, wherein the neural stimulation electrode includes a subcutaneous cuff electrode.

37. The device of claim 28, further comprising a conductive housing, wherein the neural stimulation electrode includes the conductive housing.

38. A method to provide vagal stimulation, comprising:

positioning a non-invasive neural stimulation electrode proximate to an auricular nerve branch of a vagus nerve to target the auricular nerve branch for neural stimulation, including positioning a bipolar electrode past a conch of an outer ear into an external auditory canal, wherein the auricular nerve branch innervates surfaces of the outer ear and skin over a parotid gland and mastoid process near the outer ear, and wherein positioning the bipolar electrode in the external auditory canal includes placing the bipolar electrode within the external auditory canal effectively proximate to the outer ear near the auricular nerve branch to deliver stimulation from the external auditory canal out toward the auricular nerve branch; and

applying a neural stimulation signal to the electrode appropriately placed within the external auditory canal to transcutaneously stimulate the auricular nerve branch from the external auditory canal.

39. The method of claim 38, wherein applying a neural stimulation signal to the electrode includes intermittently applying the neural stimulation signal in an open loop neural stimulation system.

40. The method of claim 38, wherein applying a neural stimulation signal to the electrode includes periodically applying the neural stimulation signal in an open loop neural stimulation system.

41. The method of claim 38, wherein applying a neural stimulation signal to the electrode includes adjusting the neural stimulation signal in a closed-loop neural stimulation system, the closed-loop neural stimulation system including a feedback signal indicative of a physiological signal.

42. The method of claim 41, further comprising sensing a heart rate to provide the feedback signal.

43. The method of claim 42, wherein sensing a heart rate includes sensing the heart rate from a carotid artery.

44. The method of claim 41, further comprising sensing a blood pressure to provide the feedback signal.

45. The method of claim 44, wherein sensing a blood pressure includes sensing the blood pressure from a carotid artery.

46. The method of claim 41, further comprising detecting an electrocardiogram (ECG) signal to provide the feedback signal.