Baroreflex modulation to gradually decrease blood pressure

• US 7,486,991 B2
• Filed: 12/24/2003
• Issued: 02/03/2009
• Est. Priority Date: 12/24/2003
• Status: Expired due to Fees

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Spinelli, Julio C., Libbus, Imad
• Primary Examiner(s): Evanisko; George R
• Assistant Examiner(s): KAHELIN, MICHAEL WILLIAM
• Application Number:
  US10/746,845
• Publication Number:
  US 20050149131A1
• Time in Patent Office: 1,868 Days
• Field of Search: 607/44, 607/18, 607/23, 607/118
• US Class Current: 607/44
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/3611 Respiration control stimulating respiratory organs A61N1/3601
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36117 for treating hypertension
• CPC Class Codes: A61N 1/36146 specified by the stimulation parameters
• CPC Class Codes: A61N 1/36564 controlled by blood pressure

Abstract

An aspect of the present subject matter relates to a baroreflex stimulator. An embodiment of the stimulator includes a pulse generator to provide a baroreflex stimulation signal through an electrode, and a modulator. The modulator modulates the baroreflex stimulation signal to increase the baroreflex stimulation therapy by a predetermined rate of change to lower systemic blood pressure to a target pressure. Other aspects are provided herein.

Claims

1. A baroreflex stimulator, including:

a pulse generator to provide a baroreflex stimulation signal through an electrode for a baroreflex therapy;

a blood pressure sensor to provide a sensed blood pressure signal;

a memory to store a target blood pressure, a time duration that defines a time period beginning with an event trigger for sensed blood pressure to reach the target blood pressure, and a programmed algorithm for determining a rate of change for progressively increasing a level of the baroreflex therapy using the sensed blood pressure signal, the target blood pressure, and the time duration, wherein the programmed algorithm is adapted to determine the rate of change to progressively decrease sensed blood pressure to the target blood pressure by an end of the time period; and

a modulator operatively connected to the pulse generator, the blood pressure sensor and the memory to implement the programmed algorithm in the memory to modulate the baroreflex stimulation signal to progressively increase the level of the baroreflex stimulation therapy by the rate of change determined by the algorithm to progressively lower sensed blood pressure to the target pressure by the end of the time period.

2. The system of claim 1, wherein the baroreflex signal has an amplitude, and the modulator includes a modulator to modulate the amplitude to increase the baroreflex stimulation therapy by the predetermined rate of change.

3. The system of claim 1, wherein the baroreflex signal has a frequency, and the modulator includes a modulator to modulate the frequency to increase the level of the baroreflex stimulation therapy by the rate of change determined by the algorithm.

4. The system of claim 1, wherein the baroreflex signal has a burst frequency, and the modulator includes a modulator to modulate the burst frequency to increase the level of the baroreflex stimulation therapy by the rate of change determined by the algorithm.

5. The stimulator of claim 1, further comprising a waveform generator to produce baroreceptor signals of a desired morphology, wherein the modulator includes a modulator to change the morphology of the baroreflex stimulation signal to increase the level of the baroreflex stimulation therapy by the rate of change determined by the algorithm.

6. The stimulator of claim 1, wherein the time duration and the programmed algorithm for determining the rate of change controls the rate of change to reverse remodel vascular stiffening.

7. The stimulator of claim 1, further comprising a cardiac output monitor to provide a monitored cardiac output, wherein the algorithm is adapted to modify the rate of change if the monitored cardiac output is not acceptable.

8. The stimulator of claim 1, wherein the pressure sensor includes a pressure detector to monitor arterial pressure and provide an arterial pressure signal.

9. The stimulator of claim 1, wherein the baroreflex stimulation signal has a white noise distribution to mimic a nerve traffic distribution.

10. The stimulator of claim 1, further comprising a lead adapted to be electrically connected to the pulse generator, the lead including the electrode and adapted to be fed through a right ventricle and a pulmonary valve such that the electrode is positioned near a baroreceptor site in a pulmonary artery.

11. The stimulator of claim 1, wherein the time duration is two or more weeks, and the algorithm determines the rate of change to progressively increase the level of the baroreflex therapy over the two or more weeks.

12. The stimulator of claim 1, wherein the time duration is two or more months, and the algorithm determines the rate of change to progressively increase the level of the baroreflex therapy over the two or more months.

47. The stimulator of claim 1, wherein the time duration is on the order of weeks to months, the rate of change is determined using the time duration on the order of weeks to months, and the level of baroreflex therapy is progressively increased for a time on the order of weeks to months.

13. An implantable medical system, comprising:

means for sensing blood pressure;

means for applying a baroreflex therapy, including means for applying baroreflex stimulation to a pressoreceptive region to lower systemic blood pressure; and

means for progressively increasing a level of the baroreflex stimulation therapy by a rate of change over a time period pre-programmed into the implantable medical system to progressively lower sensed blood pressure to a target pressure by an end of the time period as the level of the baroreflex therapy is progressively increased by the rate of change, wherein the means for progressively increasing the level includes means for determining the rate of change to reach the target pressure by the end of the time period using the time period, sensed blood pressure and the target pressure to cause the system blood pressure to be progressively lowered during the time period.

14. The system of claim 13, wherein the means for applying baroreflex stimulation to a pressoreceptive region to lower systemic blood pressure includes means for applying baroreflex stimulation therapy to a baroreceptor region in a pulmonary artery.

15. The system of claim 13, wherein the means for applying baroreflex stimulation to a pressoreceptive region to lower systemic blood pressure includes means for applying baroreflex stimulation therapy to a baroreflex neural target in a cardiac fat pad.

16. The system of claim 13, wherein the means for applying baroreflex stimulation to a pressoreceptive region to lower systemic blood pressure includes means for transvascularly applying baroreceptor stimulation to an afferent nerve using an electrode in a vessel.

17. The system of claim 16, wherein the means for applying baroreceptor stimulation using an electrode in a vessel includes means for stimulating an aortic nerve.

18. The system of claim 16, wherein the means to apply baroreceptor stimulation using an electrode in a vessel includes means to stimulate a carotid sinus nerve.

19. The system of claim 16, wherein means for applying baroreceptor stimulation using an electrode in a vessel includes means for stimulating a vagus nerve.

20. The system of claim 16, wherein means for applying baroreceptor stimulation using an electrode in a vessel includes means for stimulating a baroreflex neural target in a cardiac fat pad.

21. The system of claim 13, wherein the means for applying baroreflex stimulation to a pressoreceptive region to lower systemic blood pressure includes means for stimulating an afferent nerve using a cuff electrode.

22. The system of claim 21, wherein means for stimulating an afferent nerve using a cuff electrode includes means for stimulating an aortic nerve.

23. The system of claim 21, wherein means for stimulating an Afferent nerve using a cuff electrode includes means for stimulating a carotid sinus nerve.

24. The system of claim 21, wherein means for stimulating an Afferent nerve using a cuff electrode includes means for stimulating a vagus nerve.

25. The system of claim 13, wherein the means for applying baroreflex stimulation to a pressoreceptive region to lower systemic blood pressure includes means for stimulating a baroreflex neural target in a cardiac fat pad using an electrode screwed into the cardiac fat pad.

26. The system of claim 13, wherein the means for applying baroreflex stimulation to a pressoreceptive region to lower systemic blood pressure includes means for applying stimulation with a white noise distribution to mimic nerve traffic distribution.

48. The system of claim 13, wherein the time duration is on the order of weeks to months, the rate of change is determined using the time duration on the order of weeks to months, and the level of baroreflex therapy is progressively increased for a time on the order of weeks to months.

27. A method for operating an implantable medical device, comprising:

sensing a blood pressure;

applying a baroreflex stimulation therapy using a baroreflex stimulator in the implantable medical device;

implementing an algorithm programmed in the implantable medical device to determine a rate of change for increasing a level of the baroreflex therapy using sensed blood pressure, a programmed target pressure, and a programmed time duration that defines a time period beginning with an event trigger for sensed blood pressure to reach the target blood pressure; and

increasing a level of the baroreflex stimulation therapy by the rate of change determined by the algorithm to progressively lower sensed blood pressure to the target pressure as the level of the baroreflex therapy is progressively increased during the time period by the determined rate of change.

28. The method of claim 27, wherein the time duration and the rate of change controls the rate to reverse remodel vascular stiffening.

29. The method of claim 27, wherein increasing the baroreflex stimulation therapy by the rate of change to lower systemic blood pressure to a target pressure includes:

implementing a process to control the rate of change for increasing the baroreflex stimulation; and

modifying the determined rate of change if cardiac output is not acceptable.

30. The method of claim 27, wherein applying a baroreflex stimulation therapy using a baroreflex stimulator in the implantable medical device includes applying baroreflex stimulation therapy to a baroreceptor region in a pulmonary artery using a lead fed through a right ventricle and pulmonary valve into the pulmonary artery.

31. The method of claim 27, wherein increasing a level of the baroreflex stimulation therapy by the rate of change includes modulating an amplitude of a baroreflex stimulation signal.

32. The method of claim 27, wherein increasing a level of the baroreflex stimulation therapy by the rate of change includes modulating a frequency of a baroreflex stimulation signal.

33. The method of claim 27, wherein increasing a level of the baroreflex stimulation therapy by the rate of change includes modulating a pulse frequency of a baroreflex stimulation signal.

34. The method of claim 27, wherein increasing a level of the baroreflex stimulation therapy by the rate of change includes changing a morphology of a baroreflex stimulation signal.

35. The method of claim 27, wherein applying a baroreflex stimulation therapy includes applying a signal with a white noise distribution to mimic a nerve traffic distribution.

44. The method of claim 27, wherein applying a baroreflex stimulation therapy includes applying baroreflex therapy to an afferent nerve.

45. The method of claim 44, wherein applying baroreflex therapy to an afferent nerve includes using a nerve cuff to apply baroreflex therapy to the afferent nerve.

46. The method of claim 44, wherein applying baroreflex therapy to an afferent nerve includes transvascularly stimulating the afferent nerve using an intravascularly-fed lead.

49. The method of claim 27, wherein the time duration is on the order of weeks to months, the rate of change is determined using the time duration on the order of weeks to months, and the level of baroreflex therapy is progressively increased for a time on the order of weeks to months.

36. A method, comprising:

sensing a blood pressure;

applying a baroreflex stimulation therapy to a baroreceptor site using a lead extending into the pulmonary artery;

implementing an algorithm programmed in an implantable medical device to determine a rate of change for increasing a level of the baroreflex therapy using sensed blood pressure, a target pressure programmed in the implantable medical device, and a time duration programmed in the implantable medical device that defines a time period beginning with an event trigger for sensed blood pressure to reach the target blood pressure; and

implementing a process to increase the baroreflex stimulation therapy by the rate of change determined by the algorithm to progressively lower sensed blood pressure to the target pressure at an end of the time period.

37. The method of claim 36, wherein applying a baroreflex stimulation therapy to a baroreceptor site using a lead extending into the pulmonary artery includes applying a stimulation signal with a white noise distribution to mimic a nerve traffic distribution.

38. The method of claim 36, wherein implementing a process to increase the baroreflex stimulation therapy includes modulating an amplitude of a baroreflex stimulation signal.

39. The method of claim 36, wherein implementing a process to increase the baroreflex stimulation therapy includes modulating a frequency of a baroreflex stimulation signal.

40. The method of claim 36, wherein implementing a process to increase the baroreflex stimulation therapy includes modulating a burst frequency of a baroreflex stimulation signal.

41. The method of claim 36, wherein implementing a process to increase the baroreflex stimulation therapy includes changing a morphology of a baroreflex stimulation signal.

42. The method of claim 36, wherein the time duration includes a duration between approximately one to eight weeks.

43. The method of claim 36, wherein the time duration includes a duration between approximately two to twelve months.

50. The method of claim 36, wherein the time duration is on the order of weeks to months, the rate of change is determined using the time duration on the order of weeks to months, and the level of baroreflex therapy is progressively increased for a time on the order of weeks to months.