Baroreflex modulation to gradually decrease blood pressure

• US 20050149131A1
• Filed: 12/24/2003
• Published: 07/07/2005
• Est. Priority Date: 12/24/2003
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Spinelli, Julio C., Libbus, Imad
• Granted Patent: US 7,486,991 B2
• Time in Patent Office: Days
• US Class Current: 607/9
• 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; and

a modulator to modulate 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.

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 baroreflex stimulation therapy by the predetermined rate of change.

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 baroreflex stimulation therapy by the predetermined rate of change.

5. The system 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 baroreflex stimulation therapy by the predetermined rate of change.

6. The system of claim 1, wherein the predetermined rate of change is such to reverse remodel vascular stiffening.

7. The system of claim 1, further comprising a cardiac output monitor to modify the predetermined rate of change if a monitored cardiac output is not acceptable.

8. The system of claim 1, further comprising a pressure detector to monitor arterial pressure and provide an arterial pressure signal, wherein the modulator receives the arterial pressure signal to modulate the baroreflex stimulation signal adjust the predetermined rate of change.

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

10. The system 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 system of claim 1, wherein the baroreflex stimulation therapy is increased over a period of two or more weeks.

12. The system of claim 1, wherein the baroreflex stimulation therapy is increased over a period of two or more months.

13. An implantable medical system, comprising:

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

means for increasing the baroreflex stimulation therapy by a predetermined rate of change to lower systemic blood pressure to a target pressure.

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 13, 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 13, wherein means for applying baroreceptor stimulation using an electrode in a vessel includes means for stimulating a vagus nerve.

20. The system of claim 13, 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 the an aortic nerve.

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

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

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

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

increasing the baroreflex stimulation therapy by a predetermined rate of change to lower systemic blood pressure to a target pressure.

28. The method of claim 27, wherein the predetermined rate of change is such to reverse remodel vascular stiffening.

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

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

modifying the predetermined 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 the baroreflex stimulation therapy by a predetermined rate of change includes modulating an amplitude of a baroreflex stimulation signal.

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

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

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

35. The method of claim 27, wherein applying a baroreflex stimulation signal 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.

36. A method, comprising:

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

implementing a process to increase the baroreflex stimulation therapy by a predetermined rate of change until a systemic blood pressure is lowered to a target level.

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 an algorithm to increase the baroreflex stimulation therapy includes implementing an algorithm to modulate an amplitude of a baroreflex stimulation signal.

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

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

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

42. The method of claim 36, wherein implementing an algorithm to increase the baroreflex stimulation therapy by a predetermined rate of change includes increasing the baroflex stimulation therapy over a time duration of approximately one to eight weeks.

43. The method of claim 36, wherein implementing an algorithm to increase the baroreflex stimulation therapy by a predetermined rate of change includes increasing the baroflex stimulation therapy over a time duration of approximately two to twelve months.