ELECTRODE STRUCTURES AND METHODS FOR THEIR USE IN CARDIOVASCULAR REFLEX CONTROL

• US 20120130447A1
• Filed: 11/18/2011
• Published: 05/24/2012
• Est. Priority Date: 09/27/2000
• Status: Active Grant

• Current Assignee: CVRx, Inc.
• Original Assignee: CVRx, Inc.
• Inventors: Irwin, Eric D., Rossing, Martin A., Bolea, Stephen L., Kieval, Robert S., Persson, Bruce J., Serdar, David J., Keith, Peter T.
• Granted Patent: US 9,044,609 B2
• Time in Patent Office: Days
• US Class Current: 607/44
• 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, comprising:

implanting a baroreceptor activation device within a patient, the baroreceptor activation device including an electrode, wherein the baroreceptor activation device is implanted such that the electrode is on a blood vessel and proximate a baroreceptor in a wall of the blood vessel; and

activating, deactivating, or otherwise modulating the baroreceptor activation device as part of a baroreflex therapy.

2. The method of claim 1, wherein activating, deactivating, or otherwise modulating the baroreceptor activation device comprises delivering electric current through the electrode directly to the baroreceptor in the wall of the blood vessel.

3. The method of claim 1, wherein activating, deactivating, or otherwise modulating the baroreceptor activation device comprises delivering electric current through the electrode to locally stimulate the baroreceptor in the wall of the blood vessel and limit stimulation outside the vascular wall.

4. The method of claim 1, further comprising:

implanting a sensor within the patient, the sensor configured for generating a sensor signal indicative of a need for baroreflex therapy;

activating, deactivating, or otherwise modulating the baroreceptor activation device based at least in part on the sensor signal as part of the chronic baroreflex therapy.

5. The method of claim 1, wherein the blood vessel is a carotid artery.

6. The method of claim 1, wherein the blood vessel is a carotid sinus.

7. The method of claim 1, wherein the blood vessel is a subclavian artery.

8. The method of claim 1, wherein the blood vessel is an aortic arch.

9. The method of claim 1, wherein the blood vessel is a brachiocephalic artery.

10. A system, comprising:

an extravascular electrode configured for chronic implantation on a blood vessel proximate a baroreceptor within a vascular wall;

a controller coupled to the electrode, the controller programmed to deliver a baroreflex therapy to the baroreceptor via the extravascular patch electrode; and

an electrical lead coupled between the electrode and the controller.

11. The system of claim 10, wherein the electrode comprises a patch electrode.

12. The system of claim 10, wherein the electrode comprises a monopolar electrode.

13. The system of claim 10, wherein the electrode comprises a cathode.

14. The system of claim 10, wherein the controller is further programmed to locally stimulate baroreceptors in the vascular wall and to limit stimulation outside the vascular wall.

15. The system of claim 10, further comprising a sensor coupled to the controller, wherein the sensor is configured for generating a sensor signal indicative of a need for baroreflex therapy, and wherein the controller is further programmed to deliver a baroreflex therapy to the baroreceptor based at least in part on the sensor signal.

16. A method, comprising:

providing a baroreceptor activation device having an electrode;

causing the baroreceptor activation device to be implanted such that the electrode is in contact with an outer surface of a blood vessel so as to be proximate a baroreceptor in a wall of the blood vessel;

causing the baroreceptor activation device to be activated, deactivated, or otherwise modulated as part of a chronic baroreflex therapy.

17. The method of claim 16, further comprising:

providing a sensor configured for generating a sensor signal indicative of a need for baroreflex therapy;

causing the sensor to be implanted within the patient, the sensor configured for generating a sensor signal indicative of a need for baroreflex therapy;

causing the baroreceptor activation device to be activated, deactivated, or otherwise modulated based at least in part on the sensor signal as part of the chronic baroreflex therapy.

18. A baroreceptor activation system, comprising:

a sensor for generating a signal indicative of a need for baroreflex therapy;

an electrode configured to be implanted on a blood vessel and proximate a baroreceptor in a wall of the blood vessel; and

a signal generator coupled to the sensor and the electrode, the signal generator configured to generate a therapy signal as a function of the sensor signal and deliver the therapy signal through the electrode to the baroreceptor.

19. The system of claim 18, wherein the sensor is configured to sense blood pressure.

20. The system of claim 18, wherein the sensor is configured to sense heart failure.

21. The system of claim 18, wherein the therapy signal is configured to locally stimulate the baroreceptor in the vascular wall and limit stimulation outside the vascular wall.

22. The system of claim 18, wherein the electrode comprises a monopolar electrode.

23. The system of claim 18, wherein the electrode comprises a cathode.

24. A method, comprising:

providing a baroreceptor activation device having an electrode; and

providing instructions, comprising;

implanting the baroreceptor activation device within a patient such that the electrode is implanted on a blood vessel so as to be proximate a baroreceptor in a wall of the blood vessel; and

activating, deactivating, or otherwise modulating the baroreceptor activation device as part of a chronic baroreflex therapy.

25. The method of claim 24, wherein activating, deactivating, or otherwise modulating the baroreceptor activation device comprises delivering electric current through the electrode on the baroreceptor activation device to the baroreceptor in the vascular wall.

26. The method of claim 24, wherein activating, deactivating, or otherwise modulating the baroreceptor activation device comprises delivering electric current through the electrode to locally stimulate the baroreceptor in the vascular wall and limit stimulation outside the vascular wall.

27. The method of claim 24, wherein providing a baroreceptor activation device having an electrode comprises providing a baroreceptor activation device having a monopolar patch electrode.

28. The method of claim 24, further comprising:

implanting a sensor within the patient, the sensor configured for generating a sensor signal indicative of a need for baroreflex therapy;

activating, deactivating, or otherwise modulating the baroreceptor activation device based at least in part on the sensor signal as part of the chronic baroreflex therapy.