Electrode structures and methods for their use in cardiovascular reflex control

• US 8,718,789 B2
• Filed: 04/19/2010
• Issued: 05/06/2014
• Est. Priority Date: 09/27/2000
• Status: Expired due to Fees

• Current Assignee: CVRx, Inc.
• Original Assignee: CVRx, Inc.
• Inventors: Bolea, Stephen L., Kieval, Robert S., Persson, Bruce J., Serdar, David J., Keith, Peter T., Irwin, Eric D., Rossing, Martin A.
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): So, Elizabeth K
• Application Number:
  US12/762,891
• Publication Number:
  US 20100222831A1
• Time in Patent Office: 1,478 Days
• Field of Search: None
• US Class Current: 607/117
• 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 system, comprising:

an implantable baroreceptor activation device including an electrode, the device adapted to be implanted such that the electrode is on or in a blood vessel proximate a target baroreceptor in a wall of the blood vessel;

an implantable fluid delivery device, configured to deliver a fluid agent directly to the wall of the blood vessel proximate the target baroreceptor, wherein the fluid agent is configured to enhance sensitivity of the target baroreceptor to electrical stimulation delivered by the electrode; and

a control system coupled to the baroreceptor activation device and the fluid delivery device, wherein the control system is programmed to stimulate the baroreceptor via the electrode subsequent to delivery of the fluid agent directly to the wall of the blood vessel proximate the baroreceptor.

2. The system of claim 1, wherein the fluid delivery device is configured to be implanted in a location selected from the group consisting of:

intravascularly, extravascularly, and intramurally.

3. The system of claim 1, further comprising:

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.

4. The system of claim 3, wherein the delivery lumen comprises a distal and proximal seal, such that the fluid agent is retained in the lumen adjacent the vascular wall.

5. A method, comprising:

causing a baroreceptor activation device to be manufactured and made available to a user, the baroreceptor activation device having an electrode, the activation device sized and shaped for implantation proximate a baroreceptor in a wall of a blood vessel;

causing an implantable fluid delivery device to be manufactured and made available to the user, the implantable fluid delivery device having a fluid agent adapted to enhance the sensitivity of the baroreceptor to electrical stimulation;

providing instructions to the user, comprising;

implanting the baroreceptor activation device and the fluid delivery device proximate the baroreceptor, such that the electrode is on or in the blood vessel proximate the baroreceptor;

delivering the fluid agent with the fluid delivery device directly to the wall of the blood vessel proximate the baroreceptor so as to enhance the sensitivity of the baroreceptor to electrical stimulation; and

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

6. The method of claim 5, wherein the instructions for delivering the fluid agent further comprises instructions for delivering the agent from a reservoir coupled to the fluid delivery device.

7. The method of claim 5, wherein the instructions for implanting the fluid delivery device comprises instructions for implanting the fluid delivery device in a location selected from the group consisting of:

intravascularly, extravascularly, and intramurally.

8. The method of claim 5, further comprising causing a control system to be manufactured and made available to the user, the control system coupled to the baroreceptor activation device and the fluid delivery device, wherein the instructions for delivering the fluid agent comprise causing the fluid agent to be delivered in response to an output signal from the control system.

9. The method of claim 5, wherein enhancing the sensitivity of the baroreceptor to electrical stimulation comprises modifying the physiologic function of the baroreceptor.

10. The method of claim 5, wherein enhancing the sensitivity of the baroreceptor to electrical stimulation comprises modifying the physiologic function of cells of the vascular tissue surrounding the baroreceptor.

11. A method for providing therapy with a baroreceptor activation device having an electrode, the method comprising:

implanting the baroreceptor activation device within a patient such that the electrode is on or in a blood vessel proximate a baroreceptor in a wall of the blood vessel;

causing a fluid agent to be delivered directly to the wall of the blood vessel proximate the baroreceptor, the fluid agent configured to enhance the sensitivity of the baroreceptor to electrical stimulation; and

causing the baroreceptor activation device to stimulate the baroreceptor with the electrode subsequent to delivering the fluid agent.

12. The method of claim 11, further comprising:

implanting a control system, the control system coupled to the baroreceptor activation device, wherein causing the baroreceptor activation device to stimulate the baroreceptor subsequent to delivering the fluid agent comprises delivering a stimulation signal from the control system via the electrode.

13. The method of claim 12, further comprising:

causing the baroreceptor activation device to stimulate the baroreceptor at a first level of therapy; and

causing the baroreceptor activation device to stimulate the baroreceptor at a second level of therapy subsequent to delivering the fluid agent, wherein the second level of therapy is lower than the first level of therapy.

14. The method of claim 12, further comprising:

implanting a fluid delivery device, the fluid delivery device coupled to the control system and configured to deliver the fluid agent in response to an output signal from the control system.

15. The method of claim 14, wherein implanting the fluid delivery device comprises implanting the fluid delivery device in a location selected from the group consisting of:

intravascularly, extravascularly, and intramurally.

16. A method, comprising:

causing an electrical baroreceptor activation device to be manufactured and made available to a user, the electrical baroreceptor activation device including an electrode sized and shaped for implantation proximate a baroreceptor;

providing instructions to the user, comprising;

implanting the electrical baroreceptor activation device such that the electrode is on or in a blood vessel proximate a baroreceptor within a wall of the blood vessel;

delivering a fluid agent directly to the wall of the blood vessel proximate the baroreceptor, the fluid agent configured to enhance the sensitivity of the baroreceptor to electrical stimulation; and

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

17. The method of claim 16, further comprising causing a control system to be manufactured and made available to the user, the control system coupled to the electrical baroreceptor activation device, wherein stimulating the baroreceptor with the baroreceptor activation device subsequent to delivering the fluid agent comprises delivering a stimulation signal from the control system via the electrode.

18. The method of claim 17, further comprising:

stimulating the baroreceptor at a first level of therapy; and

stimulating the baroreceptor at a second level of therapy subsequent to delivering the fluid agent, wherein the second level of therapy is lower than the first level of therapy.