DEVICES AND METHODS FOR CARDIOVASCULAR REFLEX CONTROL

• US 20100179614A1
• Filed: 03/08/2010
• Published: 07/15/2010
• Est. Priority Date: 09/27/2000
• Status: Active Grant

• Current Assignee: CVRx, Inc.
• Original Assignee: CVRx, Inc.
• Inventors: Rossing, Martin A., Keith, Peter T., Serdar, David J., Persson, Bruce J., Kieval, Robert S.
• Granted Patent: US 8,583,236 B2
• Time in Patent Office: Days
• US Class Current: 607/44
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36117 for treating hypertension
• CPC Class Codes: A61N 1/37229 Shape or location of the implanted or external antenna

Abstract

Devices, systems and methods are disclosed by which the blood pressure, nervous system activity, and neurohormonal activity may be selectively and controllably reduced by activating baroreceptors. An intravascularly implantable medical device may include a sleeve formed at least in part of an expandable member configured to be movably attachable about at least a portion of an outer surface of an expandable intravascular stent, and one or more electrodes disposed on the sleeve and coupled to a control system and configured to selectively activate baroreceptors within a wall of a vessel when the expandable intravascular stent is implanted within the vessel.

Claims

1. An intravascularly implantable medical device, comprising:

a sleeve formed at least in part of an expandable member configured to be movably attachable about at least a portion of an outer surface of an expandable intravascular stent; and

one or more electrodes disposed on the sleeve and operably couplable to a control system and configured to selectively activate baroreceptors within a wall of a vessel when the expandable intravascular stent is implanted within the vessel.

2. The device of claim 1, further comprising a receiving coil disposed on the sleeve for receiving a wireless signal from the control system.

3. The device of claim 1, wherein the one or more electrodes are hard wired to the control system.

4. The device of claim 1, wherein the sleeve is tubular and wraps about the entirety of the outer surface of the expandable intravascular stent.

5. The device of claim 1, wherein the sleeve is configured to wrap about at least half of the outer surface of the expandable intravascular stent.

6. The device of claim 1, wherein the sleeve wraps about less than half of the outer surface of the expandable intravascular stent.

7. The device of claim 1, wherein the sleeve wraps about half of the outer surface of the expandable intravascular stent.

8. A system, comprising:

an expandable intravascular stent movable between a collapsed delivery position and an expanded implantation position;

a controller including a pulse generator; and

a medical device, including;

a sleeve formed at least in part of an expandable member configured to be movably attached about at least a portion of an outer surface of the expandable intravascular stent; and

one or more electrodes disposed on the sleeve and operably coupled to the controller and configured to selectively activate baroreceptors within a wall of a vessel when the expandable intravascular stent is implanted within the vessel.

9. The system of claim 8, further comprising a receiving coil disposed on the sleeve for receiving a wireless signal from the control system.

10. The system of claim 8, wherein the one or more electrodes are hard wired to the control system.

11. The system of claim 8, wherein the sleeve is tubular and wraps about the entirety of the outer surface of the expandable intravascular stent.

12. The system of claim 8, wherein the sleeve wraps about at least half of the outer surface of the expandable intravascular stent.

13. The system of claim 8, wherein the sleeve wraps about less than half of the outer surface of the expandable intravascular stent.

14. The system of claim 8, wherein the sleeve wraps about half of the outer surface of the expandable intravascular stent.

15. A method, comprising:

providing an expandable intravascular stent in a collapsed position;

providing a medical device, including a sleeve formed at least in part of an expandable member and one or more electrodes disposed on the sleeve;

providing a controller including a pulse generator; and

providing instructions, including;

attaching the medical device about the stent;

delivering the stent and the medical device to a desired location within the vasculature of a patient proximate a baroreceptor in a vessel wall;

expanding the stent from the collapsed position to an expanded implantation position such that the medical device and the stent are secured within the vasculature, operably connecting the medical device to the controller; and

activating, deactivating, or otherwise modulating the one or more electrodes on the medical device with the controller to effect a change in the baroreflex system of the patient.

16. The method of claim 15, wherein providing the medical device further includes providing a receiving coil disposed on the sleeve, and wherein activating, deactivating, or otherwise modulating the one or more electrodes on the medical device comprises wirelessly transmitting a signal from the controller to the receiving coil.

17. The method of claim 15, wherein attaching the medical device about the stent comprises releasably attaching the medical device about the stent and where delivering the stent and the medical device further comprises selectively moving the medical device relative to the stent after the stent is at the desired location.

18. A method, comprising:

attaching a medical device including a sleeve formed at least in part of an expandable member and one or more electrodes disposed on the sleeve about an expandable intravascular stent in a collapsed position;

delivering the stent and the medical device to a desired location within the vasculature of a patient proximate a baroreceptor in a vessel wall;

expanding the stent from the collapsed position to an expanded implantation position such that the medical device and the stent are secured within the vasculature;

operably connecting the medical device to a controller, including a pulse generator; and

activating, deactivating, or otherwise modulating the one or more electrodes on the medical device with the controller to effect a change in the baroreflex system of the patient.

19. The method of claim 18, wherein attaching the medical device further includes a receiving coil disposed on the sleeve, and wherein activating, deactivating, or otherwise modulating the one or more electrodes on the medical device comprises wirelessly transmitting a signal from the controller to the receiving coil.

20. The method of claim 18, wherein attaching the medical device about the stent comprises releasably attaching the medical device about the stent and where delivering the stent and the medical device further comprises selectively moving the medical device relative to the stent after the stent is at the desired location.

21. An apparatus for insertion into a blood vessel and for modulating the baroreflex system of a mammal, said apparatus comprising:

an expandable support member for engaging a wall of a blood vessel at a desired location where baroreceptors are located, said expandable support member including a lumen defined by an inner circumferential surface and an outer circumferential surface, said lumen extending between oppositely disposed first and second end portions of said expandable support member;

a continuous, sheet-like insulative material having a cylindrical configuration and being mated to said expandable support member, said insulative material extending the entire longitudinal length between said first and second end portions of said expandable support member; and

at least one electrode separately connected with said insulative material;

said insulative material for isolating blood flowing through the vessel from the electric current delivered by said at least one electrode.

22. The apparatus of claim 21, further comprising at least one sensor incorporated into the expandable support member.

23. The apparatus of claim 22, wherein the at least one sensor is positioned in or on a blood vessel.

24. The apparatus of claim 21, wherein said insulative material extends the entire length of said expandable support member.

25. The apparatus of claim 21, wherein a plurality of said electrodes is arranged in a helical fashion about said insulative material.

26. The apparatus of claim 21, wherein said insulative material extends circumferentially about the entirety of said outer circumferential surface of said expandable support member.

27. A method for modulating the baroreflex system of a mammal, said method comprising:

providing an expandable support for engaging a wall of a blood vessel at a desired location where baroreceptors are located, at least one electrode being connected with the expandable support member and arranged to selectively deliver electric current to modulate the baroreceptors, and an insulative material attached to at least a portion of the expandable support member for isolating blood flowing through the vessel from the electric current delivered by the at least one electrode;

implanting the expandable support member intravascularly so that at least a portion of the expandable support member is positioned substantially adjacent to a baroreceptor in the vessel wall; and

delivering electric current to the at least one electrode to induce a baroreceptor signal to effect a change in the baroreflex system.

28. The method of claim 27, wherein the baroreceptor signal is chemically modulated.

29. The method of claim 27, wherein the change in the baroreflex system includes a change in parasympathetic nervous system activity.

30. The method of claim 27, wherein the change in the baroreflex system includes a change in sympathetic nervous system activity.

31. The method of claim 27, wherein the change in the baroreflex system includes a change in neurohormonal activation.

32. The method of claim 27, wherein at least a portion of the expandable support member is positioned substantially adjacent to a baroreceptor in the vessel wall.

33. The method of claim 27, wherein at least a portion of the expandable support member is positioned substantially adjacent to a high pressure baroreceptor in the vessel wall.

34. The method of claim 27, wherein at least a portion of the expandable support member is positioned substantially adjacent to a baroreceptor in an arterial wall.

35. The method of claim 34, wherein at least a portion of the expandable support member is positioned substantially adjacent to a baroreceptor in the common carotid artery.

36. The method of claim 34, wherein at least a portion of the expandable support member is positioned substantially adjacent to a baroreceptor in the internal carotid artery.

37. The method of claim 34, wherein at least a portion of the expandable support member is positioned substantially adjacent to a baroreceptor in the external carotid artery.

38. The method of claim 34, wherein at least a portion of the expandable support member is positioned substantially adjacent to a baroreceptor in the carotid sinus.

39. The method of claim 27, wherein at least a portion of the expandable support member is positioned substantially adjacent to a baroreceptor in a venous wall.

40. The method of claim 27, further comprising at least one sensor incorporated into the expandable support member.

41. The method of claim 40, wherein the at least one sensor is positioned in or on a blood vessel.

42. An apparatus for insertion into a blood vessel and for modulating the baroreflex system of a mammal, said apparatus comprising:

an expandable support member for engaging a wall of a blood vessel at a desired location where baroreceptors are located, said expandable support member including a lumen defined by an inner circumferential surface and an outer circumferential surface, said lumen extending between oppositely disposed first and second end portions of said expandable support member;

at least one electrode directly connected with said outer circumferential surface of said expandable support member and arranged to selectively deliver electric current to modulate the baroreceptors; and

a continuous, sheet-like insulative material having a cylindrical configuration and being directly connected to said expandable support member, said insulative material extending the entire longitudinal length between said first and second end portions of said expandable support member, said insulative material extending circumferentially about the entirety of said lumen of said expandable support member, said insulative material for isolating blood flowing through the vessel from the electric current delivered by said at least one electrode.

43. The apparatus of claim 42, further comprising at least one sensor.