System and method for sustained baroreflex stimulation

• US 8,606,359 B2
• Filed: 04/13/2007
• Issued: 12/10/2013
• Est. Priority Date: 09/27/2000
• Status: Active Grant

• Current Assignee: CVRx, Inc.
• Original Assignee: CVRx, Inc.
• Inventors: Rossing, Martin A., Kieval, Robert S., Serdar, David J., Persson, Bruce J.
• Primary Examiner(s): HELLER, TAMMIE K
• Application Number:
  US11/735,303
• Publication Number:
  US 20070185543A1
• Time in Patent Office: 2,433 Days
• Field of Search: 607/44
• 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 1/36114 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 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 1/36514 controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by two or more physical parameters A61N1/36585

Abstract

The present invention comprises a medical device having a baroreflex stimulator to generate a stimulation signal, the stimulation signal being adapted to stimulate a baroreflex, and a controller to communicate with the baroreflex stimulator and implement a baroreflex stimulus regimen to vary an intensity of the baroreflex stimulation provided by the stimulation signal to maintain stimulation efficacy.

Claims

1. A medical device, comprising:

an implantable baroreflex activation device configured to be implanted on or in a blood vessel of a patient proximate a baroreceptor in a wall of the blood vessel; and

an implantable controller coupled to the implantable baroreflex activation device and configured to deliver a stimulation signal to the baroreceptor via the implantable baroreflex activation device, the controller including stimulus regimen stored in a memory accessible by the controller, the stimulus regimen programmed to vary an intensity of the stimulation signal to maintain responsiveness of the baroreceptor to the stimulation signal.

2. The device of claim 1, wherein the controller is adapted to modulate the stimulation signal based at least in part on a heart rate of the patient.

3. The device of claim 1, wherein the controller is adapted to deliver a stimulation signal that has a frequency within a range between 1 and 200 Hz.

4. The device of claim 1, wherein the stimulus regimen is programmed to vary a parameter of the stimulation signal, the parameter selected from the group consisting of amplitude, frequency, and duty cycle.

5. The device of claim 4, wherein the controller is adapted to modulate the frequency of the stimulation signal within a range between 1 and 200 Hz.

6. The device of claim 1, wherein the stimulus regimen is programmed to periodically modulate two or more parameters of the stimulation signal, the two or more parameters selected from the group consisting of:

amplitude, frequency, and duty cycle.

7. The device of claim 1, further comprising at least one sensor operably connected to the controller to monitor an effect of the stimulation signal and provide feedback to the controller.

8. The device of claim 7, wherein the at least one sensor includes a pressure transducer to monitor a blood pressure parameter to provide feedback to the controller.

9. The device of claim 7, wherein the at least one sensor is configured to monitor nerve activity to provide feedback to the controller.

10. The device of claim 7, wherein the at least one sensor includes a heart rate sensor to provide feedback to the controller.

11. A method, comprising:

implanting a baroreflex activation device on or in a blood vessel of a patient proximate a baroreceptor in a wall of the blood vessel;

implanting a controller within the patient, the controller coupled to the baroreflex activation device, the controller having a stimulus regimen stored therein; and

causing the controller to deliver a stimulation signal to the baroreceptor via the baroreflex activation device, the stimulation signal delivered according to the stimulus regimen, the stimulus regimen programmed to change at least one parameter of the stimulation signal such that the stimulation ranges within a range from a first stimulation level to a second stimulation level so as to maintain responsiveness of the baroreceptor to the stimulation signal.

12. The method of claim 11, wherein changing at least one parameter of the stimulation signal includes modulating the stimulation signal based at least in part on a heart rate of the patient.

13. The method of claim 11, wherein changing at least one parameter of the stimulation signal includes changing a parameter selected from the group consisting of:

frequency, amplitude, and duty cycle.

14. The method of claim 13, wherein delivering a stimulation signal includes delivering a stimulation signal having a frequency within a range between 1 and 200 Hz, and changing at least one parameter of the stimulation signal includes modulating the frequency.

15. The method of claim 11, further comprising detecting information associated with heart rate, and changing the at least one parameter of the baroreflex stimulation signal based on the information.

16. The method of claim 11, further comprising detecting a baroreflex feedback parameter.

17. The method of claim 16, wherein detecting a baroreflex feedback parameter includes detecting a blood pressure parameter using a pressure transducer.

18. The method of claim 16, wherein detecting a baroreflex feedback parameter includes detecting nerve activity using a sensor.

19. The method of claim 16, wherein detecting a baroreflex feedback parameter includes detecting a parameter associated with heart rate.

20. The method of claim 16, wherein detecting a baroreflex feedback parameter includes detecting a parameter associated with respiration.