ELECTRODE STRUCTURES AND METHODS FOR THEIR USE IN CARDIOVASCULAR REFLEX CONTROL

• US 20100222831A1
• Filed: 04/19/2010
• Published: 09/02/2010
• Est. Priority Date: 09/27/2000
• Status: Active Grant

• Current Assignee: CVRx, Inc.
• Original Assignee: CVRx, Inc.
• Inventors: Bolea, Stephen L., Keith, Peter T., Serdar, David J., Persson, Bruce J., Rossing, Martin A., Kieval, Robert S., Irwin, Eric D.
• Granted Patent: US 8,718,789 B2
• Time in Patent Office: Days
• US Class Current: 607/3
• CPC Class Codes: A61B 5/02028 Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• 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 1/36125 Details of circuitry or electric components
• CPC Class Codes: A61N 1/36135 using physiological parameters
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371

Abstract

Devices, systems and methods are described by which the blood pressure, nervous system activity, and neurohormonal activity may be selectively and controllably reduced by activating baroreceptors. A baroreceptor activation device is positioned near a baroreceptor, preferably a baroreceptor located in the carotid sinus. A control system may be used to modulate the baroreceptor activation device. The control system may utilize an algorithm defining a stimulus regimen which promotes long term efficacy and reduces power requirements/consumption. The baroreceptor activation device may utilize electrodes to activate the baroreceptors. The electrodes may be adapted for connection to the carotid arteries at or near the carotid sinus, and may be designed to minimize extraneous tissue stimulation.

Claims

1. A method for providing therapy, comprising:

implanting a baroreceptor activation device proximate a baroreceptor;

implanting a fluid delivery device, the fluid delivery device having a fluid agent adapted to enhance sensitivity of the baroreceptor to stimulation;

delivering the fluid agent with the fluid delivery device to an area proximate the baroreceptor;

stimulating the baroreceptor with the baroreceptor activation device subsequent to delivering the fluid agent with the fluid delivery device.

2. The method of claim 1, wherein implanting the baroreceptor activation device comprises implanting a mechanical baroreceptor activation device.

3. The method of claim 1, wherein implanting the baroreceptor activation device comprises implanting an electrical baroreceptor activation device.

4. The method of claim 1, wherein delivering the fluid agent comprises delivering the agent from a reservoir coupled to the fluid delivery device.

5. The method of claim 1, wherein implanting the fluid delivery device comprises implanting the fluid delivery device intravascularly.

6. The method of claim 1, wherein implanting the fluid delivery device comprises implanting the fluid delivery device extravascularly.

7. The method of claim 1, wherein implanting the fluid delivery device comprises implanting the fluid delivery device intramurally.

8. The method of claim 1, further comprising implanting a control system coupled to the baroreceptor activation device and the fluid delivery device, wherein the fluid agent is delivered in response to an output signal from a control system.

9. The method of claim 1, wherein enhancing the sensitivity of the baroreceptor to stimulation comprises modifying the physiologic function of the baroreceptor.

10. The method of claim 1, wherein enhancing the sensitivity of the baroreceptor to stimulation comprises modifying the physiologic function of cells of the vascular tissue surrounding the baroreceptor.

11. A system, comprising

an implantable baroreceptor activation device adapted to be positioned proximate a target baroreceptor in a vascular wall;

and

an implantable fluid delivery device including a fluid agent to be provided to an area proximate the target baroreceptor, wherein the fluid agent is configured to enhance sensitivity of the target baroreceptor to stimulation delivered by the baroreceptor activation device.

12. The system of claim 11 wherein the baroreceptor activation device comprises a mechanical activation device.

13. The system of claim 11, wherein the baroreceptor activation device comprises an electrical activation device.

14. The system of claim 11, wherein the fluid delivery device is configured to be implanted extravascularly.

15. The system of claim 11, wherein the fluid delivery device is configured to be implanted intravascularly.

16. The system of claim 11, wherein the fluid delivery device is configured to be implanted intramurally.

17. The system of claim 11, further comprising:

a control system coupled to the baroreceptor activation device and the fluid delivery device; and

a delivery lumen coupled between the control system and the fluid delivery device, wherein the control system is adapted to generate a control signal for delivery of the fluid agent through the delivery lumen.

18. The system of claim 11, wherein the driver comprises a pressure source and a reservoir containing the fluid agent.

19. The system of claim 17, wherein the delivery lumen comprises a distal and proximal seal, such that the fluid agent is retained in the lumen adjacent the vascular wall.

20. A method, comprising:

providing a baroreceptor activation device sized and shaped for implantation proximate a baroreceptor;

providing an implantable fluid delivery device having a fluid agent adapted to enhance the sensitivity of the baroreceptor to stimulation;

providing instructions, comprising;

implanting the baroreceptor activation device and the fluid delivery device proximate a baroreceptor;

delivering the fluid agent with the fluid delivery device to an area proximate the baroreceptor;

stimulating the baroreceptor with the baroreceptor activation device subsequent to delivering the fluid agent with the fluid delivery device.

21. The method of claim 20, wherein implanting the baroreceptor activation device comprises implanting a mechanical baroreceptor activation device.

22. The method of claim 20, wherein implanting the baroreceptor activation device comprises implanting an electrical baroreceptor activation device.

23. The method of claim 20, wherein delivering the fluid agent further comprises delivering the agent from a reservoir coupled to the fluid delivery device.

24. The method of claim 20, wherein implanting the fluid delivery device comprises implanting the fluid delivery device intravascularly.

25. The method of claim 20, wherein implanting the fluid delivery device comprises implanting the fluid delivery device extravascularly.

26. The method of claim 20, wherein implanting the fluid delivery device comprises implanting the fluid delivery device intramurally.

27. The method of claim 20, further comprising implanting a control system coupled to the baroreceptor activation device and the fluid delivery device, wherein the fluid agent is delivered in response to an output signal from a control system.

28. The method of claim 20, wherein enhancing the sensitivity of the baroreceptor to stimulation comprises modifying the physiologic function of the baroreceptor.

29. The method of claim 20, wherein enhancing the sensitivity of the baroreceptor to stimulation comprises modifying the physiologic function of cells of the vascular tissue surrounding the baroreceptor.