System and method for sustained baroreflex stimulation

• US 8,175,705 B2
• Filed: 10/12/2004
• Issued: 05/08/2012
• Est. Priority Date: 10/12/2004
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Libbus, Imad
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): MALAMUD, DEBORAH LESLIE
• Application Number:
  US10/962,845
• Publication Number:
  US 20060079945A1
• Time in Patent Office: 2,765 Days
• Field of Search: 607/9
• US Class Current: 607/14
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362

Abstract

Various aspects of the present subject matter provide an implantable medical device. In various embodiments, the device comprises a baroreflex stimulator and a controller. The baroreflex stimulator is adapted to generate a stimulation signal to stimulate a baroreflex. The controller is adapted to communicate with the baroreflex stimulator and implement a baroreflex stimulation protocol to vary an intensity of the baroreflex stimulation provided by the stimulation signal to abate baroreflex adaptation. According to various embodiments, the controller is adapted to implement the baroreflex stimulation protocol to periodically modulate the baroreflex stimulation to produce an effect that mimics an effect of pulsatile pressure. Other aspects are provided herein.

Claims

1. A medical device, comprising:

a baroreflex stimulator configured to generate a stimulation signal to stimulate a baroreflex; and

a controller configured to communicate with and control the baroreflex stimulator to deliver baroreflex stimulation with an intensity to cause a desired physiological response and implement a baroreflex stimulation protocol when the baroreflex stimulation causes the desired physiological response to maintain the desired physiological response, wherein in implementing the baroreflex stimulation protocol the controller is configured to vary the intensity of the baroreflex stimulation when the baroreflex stimulation causes the desired physiological response to abate baroreflex adaptation to the baroreflex stimulation.

2. The device of claim 1, wherein the controller is adapted to implement the baroreflex stimulation protocol to periodically modulate the intensity of the baroreflex stimulation at a rate to correspond to a naturally-occurring pulse rate.

3. The device of claim 1, wherein the baroreflex stimulator is adapted to generate a stimulation signal that has a frequency within a range between approximately 16 Hz and approximately 128 Hz.

4. The device of claim 1, wherein the baroreflex stimulation protocol includes an amplitude protocol to vary an amplitude of the stimulation signal to vary the intensity of the baroreflex stimulation to abate baroreflex adaptation.

5. The device of claim 1, wherein the baroreflex stimulation protocol includes a frequency protocol to vary a frequency of the stimulation signal to vary the intensity of the baroreflex stimulation to abate baroreflex adaptation.

6. The device of claim 5, wherein the controller is adapted to implement the frequency protocol to modulate the frequency of the stimulation signal within a range between approximately 8 Hz and approximately 256 Hz.

7. The device of claim 6, wherein the controller is adapted to implement the frequency protocol to modulate the frequency of the stimulation signal within a range between approximately 16 Hz and approximately 128 Hz.

8. The device of claim 1, wherein the baroreflex stimulation protocol includes a duty cycle modulation protocol to vary a duty cycle of the stimulation signal to vary the intensity of the baroreflex stimulation to abate baroreflex adaptation.

9. The device of claim 1, wherein the baroreflex stimulation protocol includes a combination of two or more protocols selected from the group consisting of:

an amplitude modulation protocol to periodically modulate an amplitude of the signal to periodically modulate the baroreflex stimulation;

a frequency modulation protocol to periodically modulate a frequency of the signal to periodically modulate the baroreflex stimulation; and

a duty cycle modulation protocol to periodically modulate a duty cycle of the signal to periodically modulate the baroreflex stimulation.

10. The device of claim 1, further comprising at least one baroreflex sensor operably connected to the controller to monitor an effect of the baroreflex stimulation and provide feedback for the baroreflex stimulation.

11. The device of claim 10, wherein the at least one baroreflex sensor includes a pressure transducer to monitor a blood pressure parameter to provide feedback for the baroreflex stimulation.

12. The device of claim 10, wherein the at least one baroreflex sensor includes a nerve traffic sensor to monitor nerve activity to provide feedback for the baroreflex stimulation.

13. The device of claim 10, wherein the at least one baroreflex sensor includes a heart rate sensor to provide feedback for the baroreflex stimulation.

14. The device of claim 1, further comprising a pulsation detector to detect a pulse and provide a signal indicative of at least one parameter of the pulse to the controller, wherein the baroreflex stimulation protocol is adapted to vary the baroreflex stimulation based on the pulse.

15. The device of claim 14, wherein the pulsation detector is adapted to detect a pulse rate and provide a signal indicative of the pulse rate to the controller, and the controller is adapted to implement the baroreflex stimulation protocol to modulate the baroreflex stimulation at a modulation rate approximately equal to the pulse rate.

16. The device of claim 15, wherein:

the pulsation detector is further adapted to detect a pulse phase and provide a signal indicative of the pulse phase to the controller;

the controller is adapted to implement the baroreflex stimulation protocol to modulate the baroreflex stimulation with the pulse phase such that a first pulsatile pressure during a pulse period corresponds to a first baroreflex stimulation level and a second pulsatile pressure during the pulse period corresponds to a second baroreflex stimulation level;

the first pulsatile pressure being higher than the second pulsatile pressure; and

the first baroreflex stimulation level being higher than the second baroreflex stimulation level.

17. The device of claim 1, further comprising:

a communications interface operably connected to the controller; and

an implantable housing containing the baroreflex stimulator, the controller, and the communications interface, wherein the communications interface is adapted to wirelessly communicate with a programmer.

18. The device of claim 17, further comprising a lead adapted to be connected to the baroreflex stimulator and to deliver the stimulation signal to nerve endings at a carotid sinus baroreceptor site.

19. The device of claim 17, further comprising a lead adapted to be connected to the baroreflex stimulator and to deliver the stimulation signal to nerve endings at a pulmonary artery baroreceptor site.

20. The device of claim 17, further comprising a lead adapted to be connected to the baroreflex stimulator and to deliver the stimulation signal to an afferent nerve trunk.

21. The device of claim 20, wherein the lead includes a cuff electrode to deliver the stimulation signal to the afferent nerve trunk.

22. The device of claim 17, further comprising a lead adapted to be connected to the baroreflex stimulator and to intravascularly deliver the stimulation signal from within a vessel through a vessel wall to nerve endings outside of the vessel.

23. The device of claim 17, further comprising a lead adapted to be connected to the baroreflex stimulator and to intravascularly deliver the stimulation signal from within a vessel through a vessel wall to an afferent nerve trunk outside of the vessel.

24. An implantable medical system, comprising:

means for generating a baroreflex stimulation signal to stimulate a baroreflex and cause a desired physiological response to baroreflex stimulation; and

means for abating baroreflex adaptation to maintain the desired physiological response to the baroreflex stimulation, wherein the means for abating baroreflex adaptation includes means for changing at least one parameter of the baroreflex stimulation signal when the baroreflex stimulation causes the desired response such that the baroreflex stimulation ranges within a range from a first baroreflex stimulation level and a second baroreflex stimulation level when the baroreflex stimulation causes the desired response.

25. The system of claim 24, wherein the means for changing at least one parameter of the baroreflex stimulation signal includes means for modulating the baroreflex stimulation signal at a rate corresponding to a naturally-occurring pulse rate.

26. The system of claim 24, wherein the means for changing at least one parameter of the baroreflex stimulation signal includes means for changing a frequency of the baroreflex stimulation signal.

27. The system of claim 24, wherein the means for changing at least one parameter of the baroreflex stimulation signal includes means for changing an amplitude of the baroreflex stimulation signal.

28. The system of claim 24, wherein the means for changing at least one parameter of the baroreflex stimulation signal includes means for changing a duty cycle of the baroreflex stimulation signal.

29. The system of claim 24, further comprising a single implantable device that includes the means for generating a baroreflex stimulation signal, and the means for abating baroreflex adaptation.

30. The system of claim 24, further comprising an implantable neuro stimulator (NS) device and an implantable cardiac rhythm management (CRM) device, wherein:

the NS device and the CRM device are adapted to communicate with each other;

the CRM device includes an analyzer adapted to detect pulse information;

the NS device includes the means for generating a baroreflex stimulation signal and the means for changing at least one parameter of the baroreflex stimulation signal; and

the means for changing at least one parameter of the baroreflex stimulation signal including means for changing the at least one parameter based on the pulse information.

31. A method, comprising:

generating a baroreflex stimulation signal to stimulate a baroreflex and cause a desired physiological response to baroreflex stimulation; and

abating baroreflex adaptation to maintain the desired physiological response to the baroreflex stimulation, wherein abating baroreflex adaptation includes changing at least one parameter of the baroreflex stimulation signal when the baroreflex stimulation causes the desired response such that the baroreflex stimulation ranges within a range from a first baroreflex stimulation level and a second baroreflex stimulation level when the baroreflex stimulation causes the desired response.

32. The method of claim 31, wherein changing at least one parameter of the baroreflex stimulation signal includes modulating the baroreflex stimulation signal at a rate corresponding to a naturally-occurring pulse rate.

33. The method of claim 31, wherein changing at least one parameter of the baroreflex stimulation signal includes changing a frequency of the baroreflex stimulation signal.

34. The method of claim 32, wherein generating a baroreflex stimulation signal includes generating a stimulation signal having a frequency within a range between approximately 8 Hz and approximately 256 Hz, and changing a frequency of the baroreflex stimulation signal includes modulating the frequency within the range between approximately 8 Hz and approximately 256 Hz.

35. The method of claim 34, wherein generating a baroreflex stimulation signal includes generating a stimulation signal having a frequency within a range between approximately 16 Hz and approximately 128 Hz, and changing a frequency of the baroreflex stimulation signal includes modulating the frequency within the range between approximately 16 Hz and approximately 128 Hz.

36. The method of claim 31, wherein changing at least one parameter of the baroreflex stimulation signal includes changing an amplitude of the baroreflex stimulation signal.

37. The method of claim 31, wherein changing at least one parameter of the baroreflex stimulation signal includes changing a duty cycle of the baroreflex stimulation signal.

38. The method of claim 31, further comprising detecting pulse information, and changing the at least one parameter of the baroreflex stimulation signal based on the pulse information.

39. The method of claim 38, wherein the pulse information includes a pulse rate.

40. The method of claim 39, wherein the pulse information further includes a pulse phase.

41. The method of claim 31, further comprising detecting a baroreflex feedback parameter.

42. The method of claim 41, wherein detecting a baroreflex feedback parameter includes detecting a blood pressure parameter using a pressure transducer.

43. The method of claim 41, wherein detecting a baroreflex feedback parameter includes detecting nerve traffic using a nerve traffic sensor.

44. The method of claim 41, wherein detecting a baroreflex feedback parameter includes detecting a heart rate.

45. The method of claim 41, wherein detecting a baroreflex feedback parameter includes detecting respiration.

46. The method of claim 31, wherein generating a baroreflex stimulation signal to stimulate a baroreflex includes transvascularly stimulating an afferent nerve from an electrode positioned within a blood vessel.

47. The method of claim 31, wherein generating a baroreflex stimulation signal to stimulate a baroreflex includes generating a signal to a nerve cuff electrode to stimulate an afferent nerve.

48. A medical device, comprising:

a baroreflex stimulator configured to generate a stimulation signal to stimulate a baroreflex; and

a controller configured to control the baroreflex stimulator to deliver the stimulation signal at an intensity effective for providing a desired physiological response to the stimulated baroreflex, wherein the controller is further configured to maintain the desired physiological response by abating baroreflex adaptation using a programmed stimulation protocol, wherein the controller is configured to use the programmed stimulation protocol to vary an intensity of the baroreflex stimulation provided by the stimulation signal when the delivered stimulation signal causes the desired physiological response to the stimulated baroreflex.

49. A medical device, comprising:

a baroreflex stimulator configured to generate a stimulation signal to stimulate a baroreflex;

a controller configured to communicate with the baroreflex stimulator and implement a baroreflex stimulation protocol to vary an intensity of the baroreflex stimulation provided by the stimulation signal to abate baroreflex adaptation; and

a pulsation detector to detect a pulse and provide a signal indicative of at least one parameter of the pulse to the controller, wherein the baroreflex stimulation protocol is adapted to vary the baroreflex stimulation based on the pulse, wherein the pulsation detector is adapted to detect a pulse rate and provide a signal indicative of the pulse rate to the controller, and the controller is adapted to implement the baroreflex stimulation protocol to modulate the baroreflex stimulation at a modulation rate approximately equal to the pulse rate, and wherein;

the pulsation detector is further adapted to detect a pulse phase and provide a signal indicative of the pulse phase to the controller;

the controller is adapted to implement the baroreflex stimulation protocol to modulate the baroreflex stimulation with the pulse phase such that a first pulsatile pressure during a pulse period corresponds to a first baroreflex stimulation level and a second pulsatile pressure during the pulse period corresponds to a second baroreflex stimulation level;

the first pulsatile pressure being higher than the second pulsatile pressure; and

the first baroreflex stimulation level being higher than the second baroreflex stimulation level.