Autocapture in a neurostimulator

• US 7,561,918 B2
• Filed: 01/28/2005
• Issued: 07/14/2009
• Est. Priority Date: 01/28/2005
• Status: Active Grant

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Armstrong, Randolph K., Armstrong, Scott A.
• Primary Examiner(s): SCHAETZLE, KENNEDY
• Application Number:
  US11/046,601
• Publication Number:
  US 20060173495A1
• Time in Patent Office: 1,628 Days
• Field of Search: 607/48, 607/45, 607/2, 607/28, 607/46
• US Class Current: 607/39
• 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

A method (and associated apparatus) of providing electrical neurostimulation therapy to a patient using an implanted neurostimulator comprises (a) delivering an electrical stimulation to a nerve and (b) determining whether a predetermined condition has occurred as a result of the stimulation. The method further comprises (c) if the predetermined condition has not occurred, adjusting one or more stimulation parameters; and (d) repeating (a), (b), and (c) until the predetermined condition occurs.

Claims

1. A method of providing electrical neurostimulation therapy to a patient using an implanted neurostimulator comprising:

(a) delivering an electrical stimulation to a vagus nerve, said electrical stimulation being defined by a plurality of stimulation parameter settings;

(b) determining whether a first evoked response occurs on the vagus nerve in response to said electrical stimulation, wherein said first evoked response is a desired response and comprises an induced action potential propagating on the vagus nerve; and

(c) if said first evoked response has not occurred in response to said electrical stimulation, adjusting one or more of said plurality of stimulation parameter settings.

2. The method of claim 1 further comprising, prior to (a), programming each of said plurality of stimulation parameter settings to a predetermined value.

3. The method of claim 1 further comprising, prior to (a), programming said plurality of stimulation parameter settings to produce a pulsed electrical signal that is insufficient to elicit said first evoked response.

4. The method of claim 1 wherein once said first evoked response has occurred, using the most recent plurality of stimulation parameter settings to subsequently deliver neurostimulation therapy.

5. The method of claim 1 wherein once said first evoked response has occurred, using the most recent plurality of stimulation parameter settings to subsequently deliver neurostimulation therapy.

6. The method of claim 1 wherein the first evoked response comprises a plurality of action potentials defining a desired action potential profile.

7. The method of claim 1 wherein the first evoked response comprises reaching or exceeding an action potential threshold on the vagus nerve.

8. The method of claim 1 wherein (b) further comprises determining whether a second evoked response occurs in tissue other than the vagus nerve.

9. The method of claim 8 wherein said second evoked response comprises an evoked response to the patient'"'"'s vocal cords.

10. The method of claim 8 further comprising adjusting the one or more of said plurality of stimulation parameter settings to produce the first evoked response on the vagus nerve but not produce the second evoked response.

11. The method of claim 1 wherein said plurality of stimulation parameter settings comprise settings for at least two parameters selected from the group consisting of current magnitude, frequency, pulse width, on-time and off-time.

12. The method of claim 1 further comprising, (d) repeating (a), (b), and (c) until said first evoked response on the vagus nerve occurs.

13. An implantable neurostimulator, comprising:

a pulse generator that provides an electrical pulse signal to a vagus nerve in a patient, said signal being defined by a plurality of stimulation parameters;

a stimulation lead assembly coupled to said pulse generator for delivering said electrical pulse signal to said vagus nerve, said lead assembly having a proximal end coupled to said pulse generator and a distal end comprising a stimulation electrode assembly coupled to said vagus nerve; and

control logic that;

(a) delivers an electrical stimulation to the vagus nerve;

(b) determines whether a predetermined condition has occurred as a result of said stimulation;

(c) if said predetermined condition has not occurred, adjusts one or more of said plurality of stimulation parameters; and

(d) repeats (a), (b), and (c) until the predetermined condition occurs.

14. The implantable neurostimulator of claim 13 wherein the control logic, prior to delivering the electrical stimulation in (a), sets one of said plurality of stimulation parameters to a predetermined level.

15. The implantable neurostimulator of claim 13 wherein the control logic, prior to delivering the electrical stimulation in (a), sets one or more stimulation parameters to a level that is insufficient to elicit an evoked response from the vagus nerve.

16. The implantable neurostimulator of claim 13 wherein in (b) the predetermined condition comprises an evoked response on the vagus nerve.

17. The implantable neurostimulator of claim 13 wherein once an evoked response has occurred, the control logic uses said adjusted plurality of stimulation parameters to subsequently deliver neurostimulation therapy.

18. The implantable neurostimulator of claim 13 wherein, once the predetermined condition has occurred, the control logic uses said adjusted plurality of stimulation parameters to subsequently deliver neurostimulation therapy.

19. The implantable neurostimulator of claim 13 wherein the predetermined condition comprises reaching or exceeding a maximum target excitation threshold of the vagus nerve.

20. The implantable neurostimulator of claim 13 wherein the predetermined condition comprises reaching or exceeding a threshold change in evoked response of the vagus nerve.

21. The implantable neurostimulator of claim 13 wherein in (b) the control logic determines whether a predetermined condition pertaining to the vagus nerve has occurred and determines whether tissue other than the vagus nerve has been excited by the electrical stimulation.

22. The implantable neurostimulator of claim 21 wherein said other tissue comprises a vocal cord.

23. The implantable neurostimulator of claim 21 wherein the control logic adjusts the one or more stimulation parameters to excite the vagus nerve, but not said other tissue.

24. The implantable neurostimulator of claim 13 further wherein the one or more stimulation parameters comprise current magnitude.

25. An implantable neurostimulator, comprising:

a pulse generator that provides an electrical pulse signal to a vagus nerve in a patient, said signal being defined by a plurality of stimulation parameters;

a stimulation lead assembly coupled to said pulse generator for delivering said electrical pulse signal to said vagus nerve, said lead assembly having a proximal end coupled to said pulse generator and a distal end comprising a stimulation electrode assembly coupled to said vagus nerve; and

control logic comprising;

a stimulation delivery module that delivers said electrical signal from said pulse generator to said vagus nerve;

a signal capture module that determines whether a first evoked neural response has occurred on the vagus nerve as a result of said stimulation;

an adjustment module that adjusts one or more of said plurality of stimulation parameters if said first evoked response has not occurred; and

an increment module that causes said stimulation delivery, signal capture, and increment modules to repeat their operations until said first evoked neural response occurs.

26. The implantable neurostimulator of claim 25 wherein said control logic further comprises reset logic capable of resetting said plurality of stimulation parameters to initial value settings that may thereafter be adjusted based on the operations of the stimulation delivery and signal capture modules.

27. The implantable neurostimulator of claim 26 wherein said initial value settings define an electrical pulse signal that is insufficient to elicit said first evoked neural response from the vagus nerve.

28. The implantable neurostimulator of claim 25 wherein, when said first evoked response occurs, said stimulation delivery module thereafter uses the stimulation parameters as adjusted by said adjustment module to subsequently deliver neurostimulation therapy.

29. The implantable neurostimulator of claim 25 wherein the first evoked neural response comprises a desired induced action potential propagating along the vagus nerve.

30. The implantable neurostimulator of claim 25 wherein the first evoked neural response comprises reaching or exceeding a maximum target excitation threshold of the vagus nerve.

31. The implantable neurostimulator of claim 25 wherein the first evoked neural response comprises reaching or exceeding a threshold change in evoked response of the vagus nerve.

32. The implantable neurostimulator of claim 25 wherein the signal capture sensing module further determines whether a second evoked response occurs in tissue other than said vagus nerve.

33. The implantable neurostimulator of claim 32 wherein said second evoked response occurs in a vocal cord.

34. The implantable neurostimulator of claim 32 wherein said adjustment module adjusts one or more of the plurality of stimulation parameters to produce said first evoked response but not said second evoked response.

35. The implantable neurostimulator of claim 25 wherein said plurality of stimulation parameters comprise at least two of current magnitude, frequency, pulse width, on-time and off-time.

36. A computer readable program storage device encoded with instructions that, when executed by a computer, performs a method of providing electrical neurostimulation therapy to a patient using an implanted neurostimulator comprising:

delivering an electrical stimulation to a vagus nerve, said electrical stimulation being defined by a plurality of stimulation parameter settings;

determining whether a first evoked response has occurred on the vagus nerve in response to said electrical stimulation, wherein said first evoked response is a desired response and comprises an induced action potential propagating on the vagus nerve; and

adjusting at least one of said plurality of stimulation parameter settings in response to a determination that said first evoked response has not occurred in response to said electrical stimulation.

37. A method of providing electrical neurostimulation therapy to a patient using an implanted neurostimulator comprising:

(a) delivering an electrical stimulation to a vagus nerve, said electrical stimulation being defined by a plurality of stimulation parameter settings;

(b) determining whether a first evoked response occurs on the vagus nerve in response to said electrical stimulation, wherein said first evoked response is a desired response and comprises an induced action potential propagating on the vagus nerve;

(c) if said first evoked response has not occurred in response to said electrical stimulation, adjusting one or more of said plurality of stimulation parameter settings; and

(d) if said first evoked response has occurred, using said plurality of stimulation parameter settings to deliver neurostimulation therapy.