Neural stimulation therapy system for atherosclerotic plaques

• US 7,630,760 B2
• Filed: 11/21/2005
• Issued: 12/08/2009
• Est. Priority Date: 11/21/2005
• Status: Expired due to Fees

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Baynham, Tamara Colette, Spinelli, Julio C., Libbus, Imad
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): MALAMUD, DEBORAH LESLIE
• Application Number:
  US11/284,370
• Publication Number:
  US 20070118177A1
• Time in Patent Office: 1,478 Days
• Field of Search: 607 1- 2
• US Class Current: 607/2
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/36031 using physiological parameters for adjustment
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36135 using physiological parameters
• CPC Class Codes: A61N 1/362 Heart stimulators heart defibrillators A61N1/39

Abstract

A neural stimulation therapy system for atherosclerotic plaques is provided. One aspect of this disclosure relates to a medical device for applying neural stimulation therapy for atherosclerotic plaques. The device includes a neural stimulator adapted to deliver an electrical signal through at least one electrode to an autonomic neural target. The device also includes a controller to control the neural stimulator to provide a therapy for atherosclerotic plaques. The device is external to a human body in an embodiment, and includes an implantable medical device (IMD) in various embodiments. According to an embodiment, the device includes a neural stimulation lead connected to the neural stimulator. The neural stimulator delivers electrical signals with waveform parameters based on sensed arterial blockage levels, according to various embodiments. Other aspects and embodiments are provided herein.

Claims

1. A medical device, comprising:

at least one neural stimulation electrode adapted to be placed proximate to a site of atherosclerosis to enable stimulation of the site of atherosclerosis or stimulation of a peripheral neural pathway that is proximate to and that innervates the site of atherosclerosis;

a neural stimulator adapted to deliver an electrical signal through the at least one electrode to stimulate the site of atherosclerosis or to stimulate the peripheral neural pathway proximate to the site of atherosclerosis to provide local therapy that reduces an inflammatory response at the site of atherosclerosis; and

a programmed controller, wherein the controller is programmed with a therapy for atherosclerotic plaques to control the neural stimulator to intermittently deliver stimulation through the electrode to provide local therapy that reduces the inflammatory response at the site of the atherosclerosis and

to prevent plaque formation and promote stability of existing plaque.

2. The device of claim 1, wherein the device includes an implantable medical device (IMD).

3. The device of claim 1, wherein the device includes a neural stimulator external to a human body.

4. The device of claim 3, wherein the neural stimulator is adapted to deliver therapy transcutaneously.

5. The device of claim 1, wherein the at least one electrode includes an expandable electrode adapted to provide mechanical and electrical anti-atherosclerotic therapy.

6. The device of claim 1, wherein the neural stimulator delivers electrical signals with waveform parameters determined at least in part on sensed arterial blockage levels.

7. A medical device, comprising:

a sensing circuit to receive sensed signals representative of blood flow in a vessel to determine extent of blockage at a site of atherosclerosis;

at least one neural stimulation electrode adapted to be placed proximate to the site of atherosclerosis to enable stimulation of the site of atherosclerosis or stimulation of a peripheral neural pathway that is proximate to and that innervates the site of atherosclerosis;

a neural stimulator adapted to deliver an electrical signal through the at least one electrode to stimulate the site of atherosclerosis or to stimulate the peripheral neural pathway proximate to the site of atherosclerosis to provide local therapy that reduces an inflammatory response at the site of atherosclerosis; and

a programmed controller to communicate with the sensing circuit, wherein the controller is programmed with a therapy for atherosclerotic plagues to control the neural stimulator to intermittently deliver stimulation through the electrode to provide local therapy that reduces the inflammatory response at the site of atherosclerosis and to prevent plaque formation and promote stability of existing plaque, the controller adapted to control delivery of the electrical signal with waveform parameters modulated based on the determined extent of blockage.

8. The device of claim 7, further comprising:

a pacing circuit adapted to provide cardiac rhythm management therapy.

9. The device of claim 8, wherein neural stimulation therapy is delivered in conjunction with cardiac rhythm management therapy.

10. The device of claim 8, wherein neural stimulation therapy is delivered in conjunction with cardiac preconditioning therapy.

11. The device of claim 8, wherein neural stimulation therapy is delivered in conjunction with cardiac postconditioning therapy.

12. A system, comprising:

at least one neural stimulation lead having a proximal portion and a distal portion;

a plurality of electrodes along the distal portion of the at least one lead, at least one of the plurality of electrodes adapted to be placed proximate to a site of atherosclerosis to enable stimulation of the site of atherosclerosis or stimulation of a peripheral neural pathway that is proximate to and that innervates the site of atherosclerosis; and

a medical device coupled to the proximal portion of the at least one lead, the medical device including;

a neural stimulator adapted to deliver an electrical signal through the at least one electrode to stimulate the site of atherosclerosis or to stimulate the peripheral neural pathway proximate to the site of atherosclerosis to provide local therapy that reduces an inflammatory response at the site of atherosclerosis; and

a programmed controller, wherein the controller is programmed with a therapy for atherosclerotic plagues to control the neural stimulator to intermittently deliver stimulation through the electrode to provide local therapy that reduces the inflammatory response at the site of the atherosclerosis and

to prevent plaque formation and promote stability of existing plaque.

13. The system of claim 12, wherein the at least one lead includes a lead with an expandable portion.

14. The system of claim 13, wherein the lead with the expandable portion is placed in a pulmonary artery in proximity of a high concentration of baroreceptors.

15. The system of claim 12, wherein the at least one lead includes a transvascular lead.

16. The system of claim 15, wherein the transvascular lead is placed proximal to a cardiac fat pad.

17. The system of claim 15, wherein the transvascular lead is placed proximal to an aortic nerve.

18. The system of claim 15, wherein the transvascular lead is placed proximal to a carotid nerve.

19. The system of claim 15, wherein the transvascular lead is placed proximal to a vagus nerve.

20. The system of claim 12, wherein the at least one lead includes an epicardial lead.

21. The system of claim 20, wherein the epicardial lead is placed in a cardiac fat pad.

22. The system of claim 12, wherein the plurality of electrodes includes at least one cuff electrode.

23. The system of claim 22, wherein the cuff electrode is placed around an aortic nerve.

24. The system of claim 22, wherein the cuff electrode is placed around a carotid nerve.

25. The system of claim 22, wherein the cuff electrode is placed around a vagus nerve.

26. The system of claim 12, wherein the medical device includes a pacemaker.

27. A system, comprising:

means for monitoring blood pressure in a vessel to determine extent of blockage; and

means for applying neural stimulation based on the extent of blockage, the stimulation adapted to reduce inflammatory response to a site of atherosclerosis to provide a therapy for atherosclerotic plaques;

wherein the means for applying neural stimulation is adapted to intermittently stimulate a peripheral neural pathway that innervates the site of atherosclerosis to prevent plaque formation and promote stability of existing plaque.

28. The system of claim 27, further comprising:

means for applying cardiac rhythm management therapy.

29. The system of claim 27, further comprising:

means for monitoring blood flow in a vessel to determine extent of blockage.

30. The system of claim 27, wherein the means for applying neural stimulation includes at least one lead.

31. The system of claim 30, wherein the at least one lead is placed in a location known to activate the parasympathetic nervous system.

32. The system of claim 30, wherein the at least one lead is placed in proximity to a site of atherosclerosis.

33. A method, comprising:

monitoring blood flow in a vessel to determine extent of blockage;

placing a neural stimulation lead in proximity to a site of atherosclerosis;

applying neural stimulation using an electrical signal with waveform parameters modulated based on the determined extent of blockage, the stimulation adapted to reduce inflammatory response to the site of atherosclerosis to provide a therapy for atherosclerotic plaques; and

preventing plaque formation and promoting stability of existing plaque by applying neural stimulation including stimulating a peripheral neural pathway that innervates the site of atherosclerosis.

34. The method of claim 33, further comprising:

monitoring blood pressure in a vessel to determine extent of blockage.

35. The method of claim 33, further comprising:

applying cardiac rhythm management therapy in conjunction with neural stimulation therapy.

36. The method of claim 33, further comprising:

applying cardiac preconditioning therapy in conjunction with neural stimulation therapy;

wherein the cardiac preconditioning therapy is applied when the extent of blockage reaches a predefined threshold.

37. The method of claim 33, further comprising:

applying cardiac postconditioning therapy in conjunction with neural stimulation therapy;

wherein the cardiac postconditioning therapy is applied when the extent of blockage reaches a predefined threshold.

38. The method of claim 33, wherein applying neural stimulation includes applying electrical signals proximate a site of atherosclerosis.

39. The method of claim 33, wherein applying neural stimulation includes stimulating an autonomic neural target.

40. A method, comprising:

monitoring blood flow in a vessel to determine extent of blockage;

applying neural stimulation based on the extent of blockage, the stimulation adapted to provide a therapy for atherosclerotic plaques, including reducing inflammatory response to a site of atherosclerosis;

applying cardiac preconditioning therapy in conjunction with neural stimulation therapy; and

wherein the cardiac preconditioning therapy is applied when the extent of blockage reaches a predefined threshold.

41. A method, comprising:

monitoring blood flow in a vessel to determine extent of blockage;

applying neural stimulation based on the extent of blockage, the stimulation adapted to provide a therapy for atherosclerotic plaques, including reducing inflammatory response to a site of atherosclerosis;

applying cardiac postconditioning therapy in conjunction with neural stimulation therapy; and

wherein the cardiac postconditioning therapy is applied when the extent of blockage reaches a predefined threshold.

42. A medical device, comprising:

a sensing circuit to receive sensed signals representative of blood flow in a vessel to determine extent of blockage;

a neural stimulator adapted to deliver an electrical signal through at least one electrode to an autonomic neural target;

a controller to communicate with the sensing circuit and to control the neural stimulator to reduce inflammatory response to a site of atherosclerosis to provide a therapy for atherosclerotic plaques;

a pacing circuit adapted to provide cardiac rhythm management therapy;

wherein the neural stimulator and the at least one electrode cooperate to stimulate a peripheral neural pathway that innervates the site of atherosclerosis; and

wherein neural stimulation therapy is delivered in conjunction with cardiac preconditioning therapy.

43. A medical device, comprising:

a sensing circuit to receive sensed signals representative of blood flow in a vessel to determine extent of blockage;

a neural stimulator adapted to deliver an electrical signal through at least one electrode to an autonomic neural target;

a controller to communicate with the sensing circuit and to control the neural stimulator to reduce inflammatory response to a site of atherosclerosis to provide a therapy for atherosclerotic plaques;

a pacing circuit adapted to provide cardiac rhythm management therapy;

wherein the neural stimulator and the at least one electrode cooperate to stimulate a peripheral neural pathway that innervates the site of atherosclerosis; and

wherein neural stimulation therapy is delivered in conjunction with cardiac postconditioning therapy.