SYSTEM AND METHOD FOR SUSTAINED BAROREFLEX STIMULATION

• US 20070185543A1
• Filed: 04/13/2007
• Published: 08/09/2007
• Est. Priority Date: 09/27/2000
• Status: Active Grant

• Current Assignee: CVRx, Inc.
• Original Assignee: CVRx, Inc.
• Inventors: Kieval, Robert, Rossing, Martin, Persson, Bruce, Serdar, David
• Granted Patent: US 8,606,359 B2
• Time in Patent Office: Days
• 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:

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.

2. The device of claim 1, wherein the controller is adapted to implement the baroreflex stimulus regimen to periodically modulate the intensity of the baroreflex stimulation at a rate to correspond to a naturally-occurring pulse rate.

3. The device of claim 1, wherein the baroreflex stimulator is adapted to generate a stimulation signal that has a frequency within a range about 20 Hz.

4. The device of claim 1, wherein the baroreflex stimulus regimen is adapted 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 about 20 Hz.

6. The device of claim 1, wherein the baroreflex stimulus regimen is adapted 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 control system to monitor an effect of the baroreflex stimulation and provide feedback for the baroreflex stimulation.

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 for the baroreflex stimulation.

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

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

11. The device of claim 1, further comprising a sensor to detect a parameter associated with a heart rate and provide a signal indicative of the sensed parameter to the controller, wherein the baroreflex stimulus regimen is adapted to vary the baroreflex stimulation based on the parameter.

12. The device of claim 11, wherein:

the sensor is further adapted to detect a pulse pressure parameter and provide a signal indicative of the pulse pressure parameter to the controller;

the controller is adapted to implement the baroreflex stimulus regimen to modulate the baroreflex stimulation with the pulse pressure parameter such that a first pulsatile pressure during a pulse period corresponds to a first baroreflex stimulation level and a second pulsatile pressure during the pulse period corresponds to a second baroreflex stimulation level;

the first pulsatile pressure being higher than the second pulsatile pressure; and

the first baroreflex stimulation level being higher than the second baroreflex stimulation level.

13. The device of claim 1, further comprising a communications interface operably connected to the controller and an implantable housing containing the baroreflex stimulator, the controller, and the communications interface, wherein the communications interface is adapted to wirelessly communicate with a programmer.

14. The device of claim 13, further comprising a lead adapted to be connected to the baroreflex stimulator and to deliver the stimulation signal to a carotid sinus baroreceptor site.

15. The device of claim 13, further comprising a lead adapted to be connected to the baroreflex stimulator and to intravascularly deliver the stimulation signal from within a vessel through a vessel wall to nerve endings outside of the vessel.

16. An implantable medical system, comprising:

means for generating a baroreflex stimulation signal to stimulate a baroreflex; and

means for maintaining stimulation efficacy, including means for changing at least one parameter of the baroreflex stimulation signal such that the baroreflex stimulation ranges within a range from a first baroreflex stimulation level and a second baroreflex stimulation level.

17. The system of claim 16, wherein the means for changing at least one parameter of the baroreflex stimulation signal includes means for modulating the baroreflex stimulation signal at a rate corresponding to a naturally-occurring pulse rate.

18. The system of claim 16, wherein the means for changing at least one parameter of the baroreflex stimulation signal includes means for changing a parameter of the baroreflex stimulation signal, the parameter selected from the group consisting of:

frequency, amplitude, and duty cycle.

19. The system of claim 16, further comprising a single implantable device that includes the means for generating a baroreflex stimulation signal, and the means for abating baroreflex adaptation.

20. A method, comprising:

generating a baroreflex stimulation signal to stimulate a baroreflex; and

maintaining stimulation efficacy, including changing at least one parameter of the baroreflex stimulation signal such that the baroreflex stimulation ranges within a range from a first baroreflex stimulation level and a second baroreflex stimulation level.

21. The method of claim 20, wherein changing at least one parameter of the baroreflex stimulation signal includes modulating the baroreflex stimulation signal at a rate corresponding to a naturally-occurring pulse rate.

22. The method of claim 20, wherein changing at least one parameter of the baroreflex stimulation signal includes changing a parameter of the baroreflex stimulation signal, the parameter selected from the group consisting of:

frequency, amplitude, and duty cycle.

23. The method of claim 22, wherein generating a baroreflex stimulation signal includes generating a stimulation signal having a frequency within a range about 20 Hz, and changing a frequency of the baroreflex stimulation signal includes modulating the frequency.

24. The method of claim 20, further comprising detecting information associated with heart rate, and changing the at least one parameter of the baroreflex stimulation signal based on the information.

25. The method of claim 24, wherein the pulse information further includes a pulse pressure parameter.

26. The method of claim 20, further comprising detecting a baroreflex feedback parameter.

27. The method of claim 26, wherein detecting a baroreflex feedback parameter includes detecting a blood pressure parameter using a pressure transducer.

28. The method of claim 26, wherein detecting a baroreflex feedback parameter includes detecting nerve activity using a sensor.

29. The method of claim 26, wherein detecting a baroreflex feedback parameter includes detecting a parameter associated with heart rate.

30. The method of claim 26, wherein detecting a baroreflex feedback parameter includes detecting a parameter associated with respiration.