Techniques for reducing pain associated with nerve stimulation

• US 8,571,651 B2
• Filed: 02/07/2011
• Issued: 10/29/2013
• Est. Priority Date: 09/07/2006
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: BioControl Medical (B.C.M) Ltd.
• Inventors: Ben-Ezra, Omry, Ben-David, Tamir, Cohen, Ehud
• Primary Examiner(s): PATTON, AMANDA K
• Application Number:
  US13/022,199
• Publication Number:
  US 20110137365A1
• Time in Patent Office: 995 Days
• Field of Search: 607/2, 607/116, 607/118
• US Class Current: 607/2
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362

Abstract

Apparatus is provided including an electrode device and a control unit. The electrode device is configured to be coupled to a site of a subject selected from the group consisting of: a vagus nerve, an epicardial fat pad, a pulmonary vein, a carotid artery, a carotid sinus, a coronary sinus, a vena cava vein, a right ventricle, a right atrium, and a jugular vein. The control unit is configured to drive the electrode device to apply to the site a current in at least first and second bursts, the first burst including a plurality of pulses, and the second burst including at least one pulse, and set (a) a pulse repetition interval (PRI) of the first burst to be on average at least 20 ms, (b) an interburst interval between initiation of the first burst and initiation of the second burst to be less than 10 seconds, (c) an interburst gap between a conclusion of the first burst and the initiation of the second burst to have a duration greater than the average PRI, and (d) a burst duration of the first burst to be less than a percentage of the interburst interval between, the percentage being less than 67%. Other embodiments are also described.

Claims

1. Apparatus comprising:

an electrode device, configured to be coupled to a site of a subject;

a sensor, configured to sense a physiological parameter of the subject indicative of cardiac activity of the subject; and

a control unit, configured to;

drive the electrode device to apply to the site a current in at least first and second bursts, the first burst including a plurality of pulses, and the second burst including at least one pulse,

synchronize the first and second bursts with a feature of a cardiac cycle of the subject, and

set (a) a pulse repetition interval (PRI) of the first burst to be on average at least 30 ms, (b) an interburst interval between initiation of the first burst and initiation of the second burst to be less than 10 seconds, (c) an interburst gap between a conclusion of the first burst and the initiation of the second burst to have a duration greater than the average PRI, and (d) a burst duration of the first burst to be less than a percentage of the interburst interval, the percentage being less than 67%.

2. The apparatus according to claim 1, wherein the control unit is configured to set the percentage to be less than 33%.

3. The apparatus according to claim 1, wherein the control unit is configured to set the average PRI of the first burst to be less than 200 ms.

4. The apparatus according to claim 1, wherein the control unit is configured to set an average duration of the pulses of the first burst to be less than 4 ms.

5. The apparatus according to claim 1, wherein the site is a nerve of the subject, and wherein the electrode device is configured to be coupled to the nerve.

6. The apparatus according to claim 5, wherein the electrode device comprises:

an electrically-insulating cuff, configured to be placed around the nerve; and

electrodes mounted in the cuff.

7. The apparatus according to claim 1, wherein the control unit is configured to:

drive the electrode device to apply the current in at least the first and the second bursts, and in at least a third burst following the second burst, wherein the second burst includes a plurality of pulses, and wherein the third burst includes at least one pulse, and

set (a) a PRI of the second burst to be on average at least 30 ms, (b) an interburst interval between initiation of the second burst and initiation of the third burst to be less than 10 seconds, (c) an interburst gap between a conclusion of the second burst and the initiation of the third burst to have a duration greater than the average PRI of the second burst, and (d) a burst duration of the second burst to be less than 67% of the interburst interval between the initiation of the second burst and initiation of the third burst.

8. The apparatus according to claim 1, wherein the control unit is configured to apply an interburst current to the site during at least a portion of the interburst gap, and to set the interburst current on average to be less than 20% of the current applied on average during the first burst.

9. The apparatus according to claim 1, wherein the control unit is configured to set the average PRI of the first burst to be at least 50 ms.

10. The apparatus according to claim 9, wherein the control unit is configured to set the average PRI of the first burst to be at least 75 ms.

11. The apparatus according to claim 1, wherein the site is selected from the group consisting of:

a vagus nerve, an epicardial fat pad, a pulmonary vein, a carotid artery, a carotid sinus, a coronary sinus, a vena cava vein, a right ventricle, a right atrium, and a jugular vein, and wherein the electrode device is configured to be coupled to the selected site.

12. The apparatus according to claim 1, wherein the control unit is configured to synchronize the first and second bursts to commence after a delay after the feature of the cardiac cycle.

13. The apparatus according to claim 12, wherein the feature of the cardiac cycle is selected from the group consisting of:

an R-wave of an ECG of the subject, and a P-wave of the ECG.

14. Apparatus comprising:

an electrode device, configured to be coupled to a site of a subject; and

a control unit, configured to;

drive the electrode device to apply to the site a current in at least first and second bursts, the first burst including a plurality of pulses, and the second burst including at least one pulse, and

set (a) a pulse repetition interval (PRI) of the first burst to be on average at least 30 ms, (b) an interburst interval between initiation of the first burst and initiation of the second burst to be between 400 ms and 1500 ms, (c) an interburst gap between a conclusion of the first burst and the initiation of the second burst to have a duration greater than the average PRI, and (d) a burst duration of the first burst to be less than a percentage of the interburst interval, the percentage being less than 67%.

15. The apparatus according to claim 14, comprising a sensor configured to sense a physiological parameter of the subject indicative of cardiac activity of the subject, wherein the control unit is configured to synchronize the first and second bursts with a feature of a cardiac cycle of the subject.

16. The apparatus according to claim 14, wherein the site is a nerve of the subject, and wherein the electrode device is configured to be coupled to the nerve.

17. The apparatus according to claim 16, wherein the electrode device comprises:

an electrically-insulating cuff, configured to be placed around the nerve; and

electrodes mounted in the cuff.

18. The apparatus according to claim 14, wherein the control unit is configured to apply an interburst current to the site during at least a portion of the interburst gap, and to set the interburst current on average to be less than 20% of the current applied on average during the first burst.

19. Apparatus comprising:

an electrode device, configured to be coupled to a site of a subject; and

a control unit, configured to;

drive the electrode device to apply to the site a current in at least first and second bursts, the first burst including between two and six pulses, and the second burst including at least one pulse, and

set (a) a pulse repetition interval (PRI) of the first burst to be on average at least 30 ms, (b) an interburst interval between initiation of the first burst and initiation of the second burst to be less than 10 seconds, (c) an interburst gap between a conclusion of the first burst and the initiation of the second burst to have a duration greater than the average PRI, and (d) a burst duration of the first burst to be less than a percentage of the interburst interval, the percentage being less than 67%.

20. The apparatus according to claim 19 wherein the control unit is configured to configure the first burst to include at least three pulses.

21. The apparatus according to claim 19, wherein the site is a nerve of the subject, and wherein the electrode device is configured to be coupled to the nerve.

22. The apparatus according to claim 21, wherein the electrode device comprises:

an electrically-insulating cuff, configured to be placed around the nerve; and

electrodes mounted in the cuff.

23. The apparatus according to claim 19, wherein the control unit is configured to apply an interburst current to the site during at least a portion of the interburst gap, and to set the interburst current on average to be less than 20% of the current applied on average during the first burst.

24. The apparatus according to claim 19, comprising a sensor configured to sense a physiological parameter of the subject indicative of cardiac activity of the subject, wherein the control unit is configured to synchronize the first and second bursts with a feature of a cardiac cycle of the subject.

25. A method comprising:

coupling an electrode device to a site of a subject selected from the group consisting of;

a vagus nerve, an epicardial fat pad, a pulmonary vein, a carotid artery, a carotid sinus, a coronary sinus, a vena cava vein, a right ventricle, a right atrium, and a jugular vein;

using the electrode device, applying, to the site, a current in at least first and second bursts, the first burst including a plurality of pulses, and the second burst including at least one pulse; and

setting (a) a pulse repetition interval (PRI) of the first burst to be on average at least 30 ms, (b) an interburst interval between initiation of the first burst and initiation of the second burst to be less than 10 seconds, (c) an interburst gap between a conclusion of the first burst and the initiation of the second burst to have a duration greater than the average PRI, and (d) a burst duration of the first burst to be less than a percentage of the interburst interval, the percentage being less than 67%.

26. The method according to claim 25, wherein setting comprises setting the percentage to be less than 33%.

27. The method according to claim 25, wherein setting comprises setting the average PRI of the first burst to be less than 200 ms.

28. The method according to claim 25, wherein setting comprises setting the interburst interval to be between 400 ms and 1500 ms.

29. The method according to claim 25, wherein applying comprises configuring the first burst to include at least three pulses.

30. The method according to claim 25, wherein applying the current comprises setting the first burst to include no more than six pulses.

31. The method according to claim 25, wherein applying the current comprises setting an average duration of the pulses of the first burst to be less than 4 ms.

32. The method according to claim 25, wherein the site includes the vagus nerve, and wherein applying the current comprises applying the current to the vagus nerve.

33. The method according to claim 25,

wherein applying comprises applying the current in at least the first and the second bursts, and in at least a third burst following the second burst, wherein the second burst includes a plurality of pulses, and wherein the third burst includes at least one pulse, and

wherein setting comprises setting (a) a PRI of the second burst to be on average at least 30 ms, (b) an interburst interval between initiation of the second burst and initiation of the third burst to be less than 10 seconds, (c) an interburst gap between a conclusion of the second burst and the initiation of the third burst to have a duration greater than the average PRI of the second burst, and (d) a burst duration of the second burst to be less than 67% of the interburst interval between the initiation of the second burst and initiation of the third burst.

34. The method according to claim 25, wherein applying the current comprises applying an interburst current to the site during at least a portion of the interburst gap, and setting the interburst current on average to be less than 20% of the current applied on average during the first burst.

35. The method according to claim 25, wherein setting comprises setting the average PRI of the first burst to be at least 50 ms.

36. The method according to claim 35, wherein setting comprises setting the average PRI of the first burst to be at least 75 ms.

37. The method according to claim 25, wherein applying the current comprises sensing a physiological parameter of the subject indicative of cardiac activity of the subject, and synchronizing the first and second bursts with a feature of a cardiac cycle of the subject.

38. The method according to claim 37, wherein synchronizing comprises synchronizing the first and second bursts to commence after a delay after the feature of the cardiac cycle.

39. The method according to claim 37, wherein the feature of the cardiac cycle is selected from the group consisting of:

an R-wave of an ECG of the subject, and a P-wave of the ECG, and wherein synchronizing comprises synchronizing the first and second bursts to commence after the delay after the selected feature of the cardiac cycle.