Devices and methods for cardiovascular reflex control

• US 6,522,926 B1
• Filed: 09/27/2000
• Issued: 02/18/2003
• Est. Priority Date: 09/27/2000
• Status: Expired due to Term

• Current Assignee: CVRx, Inc.
• Original Assignee: CVRx, Inc.
• Inventors: Burns, Matthew M., Kieval, Robert S., Hansen, Gina L., Keith, Peter T., Hektner, Thomas R.
• Primary Examiner(s): Jastrzab, Jeffrey R.
• Assistant Examiner(s): Oropeza, Frances P.
• Application Number:
  US09/671,850
• Time in Patent Office: 874 Days
• Field of Search: 600/300, 600/377, 600/381, 600/372, 600/373, 600/483, 604/20, 607/2, 607/44, 607/62, 607/115, 607/116, 607/118
• US Class Current: 607/44
• CPC Class Codes: A61N 1/36117 for treating hypertension

Abstract

Devices, systems and methods by which the blood pressure, nervous system activity, and neurohormonal activity may be selectively and controllably reduced by activating baroreceptors. By selectively and controllably activating baroreceptors, the present invention reduces excessive blood pressure, sympathetic nervous system activity and neurohormonal activity, thereby minimizing their deleterious effects on the heart, vasculature and other organs and tissues. A baroreceptor activation device is positioned near a baroreceptor, preferably in the carotid sinus and/or the aortic arch. The baroreceptor activation device may comprise a wide variety of devices which utilize mechanical, electrical, thermal, chemical or biological means to activate the baroreceptor. A control system may be used to generate a control signal to modulate the baroreceptor activation device. A sensor may be used to generate a signal indicative of cardiovascular function or other organ system function, and the control signal may be made a function of the sensor signal. The control system may include a processor and a memory, wherein the memory includes software containing an algorithm defining a relationship between the control signal and the sensor signal. The present invention also provides devices, systems and methods to selectively and controllably increase blood pressure, nervous system activity, and neurohormonal activity by inhibiting/dampening baroreceptor signals.

Claims

1. A method of activating a baroreceptor to induce a baroreceptor signal and thereby effect a change in the baroreflex system in a patient, the method comprising the steps of:

providing a baroreceptor activation device;

implanting the baroreceptor activation device intravascularly proximate a baroreceptor in a vascular wall; and

activating, deactivating or otherwise modulating the baroreceptor activation device to induce a baroreceptor signal to effect a change in the baroreflex system.

2. A method as in claim 1, wherein the change in the baroreflex system results in a decrease in sympathetic nervous system activity.

3. A method as in claim 1, wherein the change in the baroreflex system results in an increase in parasympathetic nervous system activity.

4. A method as in claim 1, wherein the change in the baroreflex system results in a decrease in neurohormonal activation.

5. A method as in claim 1, wherein the change in the baroreflex system results in a reduction in systolic blood pressure.

6. A method as in claim 1, wherein the change in the baroreflex system results in a reduction in diastolic blood pressure.

7. A method as in claim 1, wherein the change in the baroreflex system results in a reduction in mean blood pressure.

8. A method as in claim 1, wherein the change in the baroreflex system results in a reduction in pulse pressure.

9. A method as in claim 1, wherein the patient has a carotid sinus, and wherein the baroreceptor activation device is positioned proximate a baroreceptor in the carotid sinus.

10. A method as in claim 1, wherein the patient has an aortic arch, and wherein the baroreceptor activation device is positioned proximate a baroreceptor in the aortic arch.

11. A method as in claim 1, wherein the patient has a common carotid artery, and wherein the baroreceptor activation device is positioned proximate a baroreceptor in the common carotid artery.

12. A method as in claim 1, wherein the patient has a subclavian artery, and wherein the baroreceptor activation device is positioned proximate a baroreceptor in the subclavian artery.

13. A method as in claim 1, wherein the patient has an brachiocephalic artery, and wherein the baroreceptor activation device is positioned proximate a baroreceptor in the brachiocephalic artery.

14. A method as in claim 1, wherein two baroreceptor activation devices are provided, and wherein the baroreceptor activation devices are positioned proximate a baroreceptor at two different baroreceptor sites.

15. A method as in claim 1, wherein the baroreceptor activation device is surrounded at least in part by vascular wall tissue such that activation of the barorecepior activation device causes the vascular wall tissue to stretch or otherwise deform and thereby induce the baroreceptor signal.

16. A method as in claim 1, wherein the baroreceptor activation device mechanically induces the baroreceptor signal.

17. A method as in claim 1, wherein the baroreceptor activation device electrically induces the baroreceptor signal.

18. A method as in claim 1, wherein the baroreceptor activation device thermally induces the baroreceptor signal.

19. A method as in claim 1, wherein the baroreceptor activation device chemically induces the baroreceptor signal.

20. A method as in claim 1, wherein the baroreceptor activation device biologically induces the baroreceptor signal.

21. A method as in claim 1, wherein a control signal activates, deactivates and otherwise modulates the baroreceptor activation device.

22. A method as in claim 21, wherein the control signal is continuous.

23. A method as in claim 22, wherein the continuous control signal comprises a constant pulse.

24. A method as in claim 22, wherein the control signal comprises a constant train of pulses.

25. A method as in claim 22, wherein the control signal comprises a triggered pulse.

26. A method as in claim 22, wherein the control signal comprises a triggered train of pulses.

27. A method as in claim 21, wherein the control signal is periodic.

28. A method as in claim 27, wherein the control signal includes a designated start time and a designated duration.

29. A method as in claim 21, wherein the control signal is episodic.

30. A method as in claim 29, wherein the control signal is triggered when a sensor signal rises above or falls below a predetermined threshold value.

31. A method as in claim 29, wherein the control signal is triggered when a change in a sensor signal rises above or falls below a predetermined threshold value.

32. A method as in claim 29, wherein the control signal is triggered by the patient.

33. A method as in claim 29, wherein the control signal is triggered by a person other than the patient.

34. A method as in claim 1, further comprising the steps of:

providing a sensor for generating a signal indicative of a need to modify the patient'"'"'s baroreflex system;

providing a control system connected to the sensor and the baroreceptor activation device, the control system generating a control signal as a function of the sensor signal; and

wherein the baroreceptor activation device is activated, deactivated and otherwise modulated by the control signal.

35. A method as in claim 34, wherein the control system includes a processor and a memory, and wherein the memory includes software containing an algorithm defining a relationship between the control signal and the sensor signal, and wherein the baroreceptor activation device is activated, deactivated and otherwise modulated in accordance with the algorithm.

36. A method as in claim 35 wherein the algorithm dictates a continuous control signal.

37. A method as in claim 35 wherein the algorithm dictates a periodic control signal.

38. A method as in claim 35 wherein the algorithm dictates an episodic control signal.

39. A system for inducing a baroreceptor signal to effect a change in the baroreflex system in a patient, the system comprising:

a baroreceptor activation device sized and shaped for intravascular implantation proximate a baroreceptor in a vascular wall, the baroreceptor activation device comprising an electrode structure having a plurality of discrete electrode contacts arranged to contact the vascular wall upon implantation of the device in a blood vessel and to deliver electric current to locally stimulate baroreceptors in the vascular wall and to limit stimulation outside the vascular wall.

40. A system as in claim 39, further comprising:

a control system connected to the baroreceptor activation device, the control system generating a control signal to activate, deactivate or otherwise modulate the baroreceptor activation device.

41. A system as in claim 40, wherein the control system generates a continuous control signal.

42. A system as in claim 40, wherein the control system generates a control signal such that activation of the baroreceptor activation device is periodic.

43. A system as in claim 40, wherein the control system generates a control signal such that activation of the baroreceptor activation device is episodic.

44. A system as in claim 40, further comprising:

a sensor for generating a signal indicative of a need to modify the patient'"'"'s baroreflex system, the sensor connected to the control system, wherein the control signal is a function of the sensor signal.

45. A system as in claim 44, wherein the control system includes a processor and a memory, and wherein the memory includes software containing an algorithm defining a relationship between the control signal and the sensor signal, and wherein the baroreceptor activation device is activated in accordance with the algorithm.

46. A system as in claim 39, wherein the baroreceptor activation device causes the baroreceptor to deform.

47. A system as in claim 39, wherein the baroreceptor activation device causes the vascular wall to deform.

48. A system as in claim 39, wherein the electrode structure comprises a stent.

49. A system as in claim 39, further comprising an inductor for inductively activating, deactivating, or otherwise modulating the electrode structure.

50. A system as in claim 39, wherein the electrode structure is bipolar.

51. A system as in claim 39, wherein the electrode structure is tripolar.

52. A system as in claim 39, wherein the electrode structure comprises a plurality of electrically isolated coil has connected end-to-end to define the plurality of isolated electrodes.

53. A medical system for treating high blood pressure comprising:

a sensor for generating a sensor signal indicative of high blood pressure;

a signal generator for generating a control signal as a function of the sensor signal; and

an intravascular stent adapted to be positioned proximate a baroreceptor in a vascular wall and operably coupled to the signal generator, the stent comprising an electrode structure having a plurality of discrete electrode contacts arranged to locally stimulate baroreceptors in the vascular wall and to limit stimulation outside the vascular wall.

54. A method of treating high blood pressure comprising the steps of:

providing an intravascular stent and a signal generator;

positioning the stent intravascular proximate a baroreceptor in a vascular wall; and

transmitting a signal from the signal generator to the stent to induce a baroreceptor signal.

55. A medical system for treating heart failure comprising:

a sensor for generating a sensor signal indicative of heart failure;

a signal generator for generating a control signal as a function of the sensor signal; and

an intravascular stent adapted to be positioned proximate a baroreceptor in a vascular wall and operably coupled to the signal generator, the stent comprising an electrode structure having a plurality of discrete electrode contacts arranged to locally stimulate baroreceptors in the vascular wall and to limit stimulation outside the vascular wall.

56. A method of treating heart failure comprising the steps of:

providing an intravascular stent and a signal generator;

positioning the stent intravascularly proximate a baroreceptor in a vascular wall; and

transmitting a signal from the signal generator to the stent to induce a baroreceptor signal.

57. A method of inducing a baroreceptor signal to decrease blood pressure, sympathetic nervous system activity, or neurohormonal activity, the method comprising the steps of:

providing a baroreceptor activation device;

positioning the baroreceptor activation device intravascularly proximate a baroreceptor in a vascular wall; and

activating, deactivating or otherwise modulating the baroreceptor activation device to activate the baroreceptor and induce a baroreceptor signal.

58. A method of inhibiting or dampening a baroreceptor signal to increase blood pressure, nervous system activity, or neurohormonal activity, the method comprising the steps of:

providing a baroreceptor signal dampening device;

positioning the baroreceptor signal dampening device intravascularly proximate a baroreceptor in a vascular wall; and

activating, deactivating or otherwise modulating the baroreceptor signal dampening device to dampen a baroreceptor signal.

59. A method of activating a baroreceptor to induce a baroreceptor signal and thereby effect a change in the baroreflex system in a patient, the method comprising the steps of:

providing an electrical baroreceptor activation device having a plurality of discrete electrical contacts arranged to locally stimulate baroreceptors in a vascular wall and to limit stimulation outside the vascular wall;

positioning the electrical baroreceptor activation device proximate a baroreceptor in a vascular wall; and

delivering electric current through the electrical contacts on the baroreceptor activation device to the baroreceptors to stimulate a baroreceptor signal to effect a change in the baroreflex system.

60. A medical system for affecting a change in a baroreflex system of a patient, comprising:

a signal generator; and

an intravascular stent adapted to be positioned proximate a barorecepior in a vascular wall, the stent including a plurality of electrode contacts arranged for localized stimulation of baroreceptors in the vascular wall, the stent being wirelessly coupled to the signal generator.