Electrode structures and methods for their use in cardiovascular reflex control

• US 8,880,190 B2
• Filed: 11/30/2012
• Issued: 11/04/2014
• Est. Priority Date: 09/27/2000
• Status: Expired due to Fees

• Current Assignee: CVRx, Inc.
• Original Assignee: CVRx, Inc.
• Inventors: Kieval, Robert S, Keith, Peter T, Burns, Matthew, Hektner, Thomas
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): So, Elizabeth K
• Application Number:
  US13/690,016
• Publication Number:
  US 20130090700A1
• Time in Patent Office: 704 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 baroreflex modification system comprising:

a baroreceptor activation device arranged to be coupled to a vascular wall, the vascular wall containing at least one baroreceptor; and

a control system comprising a driver coupled to the baroreceptor activation device, the driver being configured to drive mechanical motion of at least a portion of the activation device, wherein the mechanical motion causes indirect activation of the baroreceptor by stretching or deforming the vascular wall surrounding the baroreceptor.

2. The system of claim 1, wherein the control system includes a processor and a programmable memory, the control system programmed to generate a control signal and deliver the control signal to the driver.

3. The system of claim 2, comprising a user interface coupled to the control system, the user interface being arranged to receive a value or a command in relation to the generated control signal, wherein the memory is configured to store data related to the generated control signal and/or the value or command received by the user interface.

4. The system of claim 2, wherein the memory stores a stimulus regimen, wherein the control system is arranged to generate the control signal in accordance with the stimulus regimen.

5. The system of claim 4, wherein the stimulus regimen is chosen to promote long term efficacy of baroreceptor activation.

6. The system of claim 4, wherein the stimulus regimen comprises a first level to establish a desired therapeutic effect and a second level to sustain the desired effect.

7. The system of claim 2, wherein the control signal comprises a continuous, periodic or episodic signal, or a combination thereof.

8. The system of claim 7, wherein an episodic control signal can be triggered by an episode wherein the episode comprises a sensed increase of a physiological parameter above a certain threshold and/or a sensed decrease below of a physiological parameter below a certain threshold.

9. The system of claim 1, wherein the activation device is arranged for pneumatic or hydraulic actuation in response to the control signal so as to compress and/or expand the tissue.

10. The system of claim 1, comprising a sensor coupled to the control system, wherein the sensor is configured to monitor a parameter indicative of a need to modify the baroreflex system and to provide to the control system a sensor signal indicative of the sensed parameter.

11. The system of claim 10, wherein the control system contains software containing an algorithm defining one or more functions or relationships between the control signal and the sensor signal, wherein the algorithm prescribes starting or stopping provision of the control signal to the driver based on the sensor signal.

12. The system of claim 11, wherein the algorithm dictates one or more of the following starting or stopping provision of the control signal when the sensor signal falls below a predetermined threshold value or rises above a predetermined threshold value or when the sensor signal indicates a specific physiological event.

13. The system of claim 1, wherein the baroreceptor activation device comprises an intravascular device.

14. The system of claim 13, wherein the activation device comprises an intravascular inflatable balloon having a geometry which allows blood perfusion therethrough.

15. The system of claim 14, wherein the driver comprises an inflation device in fluid communication with a fluid reservoir, the driver being coupled to the activation device by at least one fluid line.

16. The system of claim 15, wherein the inflation device comprises a pressure or a vacuum source.

17. The system of claim 14, wherein the intravascular inflatable balloon includes a helical geometry.

18. The system of claim 13, wherein the activation device comprises an intravascular mechanical expansion device having tubular braid configured to diametrically expand when longitudinally compressed.

19. The system of claim 13, wherein the activation device comprises an intravascular flow regulator arranged to artificially create back pressure adjacent the baroreceptor, the intravascular flow regulator comprising a valve configured to at least partially close the vascular lumen.

20. The system of claim 1, wherein the baroreceptor activation device comprises an extravascular device.

21. The system of claim 20, wherein the activation device comprises an extravascular inflatable pressure cuff.

22. The system of claim 21, wherein the driver comprises an inflation device in fluid communication with a fluid reservoir, the driver being coupled to the activation device by at least one fluid line, optionally wherein the inflation device comprises a pressure or a vacuum source.

23. The system of claim 22, wherein the inflation device comprises a pressure or a vacuum source.

24. The system of claim 20, wherein the activation device comprises an extravascular mechanical compression device, wherein the compression device comprises a piston device, the piston device being actuated by solenoid, hydraulic or pneumatic means.

25. The system of claim 24, wherein the activation device comprises an extravascular mechanical compression device, wherein the compression device comprises a rotary ring compression device.

26. The system of claim 20, wherein the activation device comprises an extravascular flow regulator arranged to artificially create back pressure adjacent the baroreceptor, the extravascular flow regulator comprising an external compression device.

27. The system of claim 1, wherein the activation device comprises a transducer, wherein the driver is an electric power generator or amplifier and is coupled to the activation device by at least one electrical lead, wherein the transducer comprises an acoustic transmitter arranged to transmit sonic or ultrasonic waves into vascular wall to cause vibration of the vascular wall.

28. The system of claim 1, wherein the activation device is configured to be implanted at a location within a patient proximate one or more baroreceptors, the location selected from the group consisting of:

a carotid sinus, an aortic arch, a common carotid artery, a subclavian artery, a brachiocephalic artery, and a heart.

29. An implantable baroreflex modification system, comprising:

a baroreceptor activation device arranged to be coupled to a vascular wall, the vascular wall containing at least one baroreceptor, wherein the activation device includes a means for mechanically activating the baroreceptor; and

a control system coupled to the baroreceptor activation device, the control system programmed to deliver a control signal to the baroreceptor activation device to cause the means for mechanically activating to stretch or deform the vascular wall surrounding the baroreceptor.

30. A method, comprising:

causing a baroreceptor activation device to be manufactured and made available to a user;

causing a control system to be manufactured and made available to the user, the control system comprising a driver coupled to the baroreceptor activation device; and

providing instructions to the user, comprising;

implanting the baroreceptor activation device in contact with a vascular wall, the vascular wall containing at least one baroreceptor; and

causing the driver to drive mechanical motion of at least a portion of the activation device, wherein the mechanical motion causes indirect activation of the baroreceptor by stretching or deforming the vascular wall surrounding the baroreceptor.