Stimulus regimens for cardiovascular reflex control

• US 20030060858A1
• Filed: 09/26/2001
• Published: 03/27/2003
• Est. Priority Date: 09/27/2000
• Status: Active Grant

• Current Assignee: CVRx, Inc.
• Original Assignee: CVRx, Inc.
• Inventors: Keith, Peter T., Serdar, David J., Kieval, Robert S., Perrson, Bruce J.
• Granted Patent: US 6,985,774 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 1/36117 for treating hypertension

Abstract

Devices, systems and methods 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, for example a baroreceptor 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.

Claims

1. A method of inducing a baroreceptor signal to affect a change in the baroreflex system of a patient, the method comprising the steps of:

providing a baroreceptor activation device; and

positioning the baroreceptor activation device proximate a baroreceptor, the baroreceptor activation device having an output which changes over time to promote long term efficacy.

2. A method as in claim 1, wherein the output of the baroreceptor activation device has a first level delivered for a first period of time, and a second level delivered for a second period of time, wherein the second level is less than the first level.

3. A method as in claim 2, wherein the first level is selected to attain a beneficial physiologic change.

4. A method as in claim 3, wherein the second level is selected to retain the beneficial physiologic change.

5. A method as in claim 1, wherein the baroreceptor activation device mechanically, electrically, thermally, chemically, or biologically induces the baroreceptor signal.

6. A method as in claim 5, wherein the output of the baroreceptor activation device comprises an electrical signal, and wherein the electrical signal induces the baroreceptor signal.

7. A method as in claim 6, wherein the electrical output signal has an amplitude, and wherein the amplitude of the first output level is greater than the amplitude of the second output level.

8. A method as in claim 6, wherein the electrical output signal comprises a series of pulses having a pulse frequency, and wherein the pulse frequency of the first output level is greater than the pulse frequency of the second output level.

9. A method as in claim 6, wherein the electrical output signal has a pulse width, and wherein the pulse width of the first output level is greater than the pulse width of the second output level.

10. A method as in claim 6, wherein the electrical output signal comprises a series of pulses delivered in bursts having a burst frequency, and wherein the burst frequency of the first output level is greater than the burst frequency of the second output level.

11. A method of inducing a baroreceptor signal to affect a change in the baroreflex system in a patient, the method comprising the steps of:

providing a baroreceptor activation device having a first electrode and a second electrode;

positioning the first electrode at a first anatomical location proximate a baroreceptor;

positioning the second electrode at a second anatomical location proximate a baroreceptor, wherein the first location is different than the second location;

alternatively activating, deactivating or otherwise modulating the electrodes of the baroreceptor activation device.

12. A method as in claim 11, wherein the first anatomical location comprises a right carotid sinus, and wherein the second anatomical location comprises a left carotid sinus.

13. A method as in claim 11, wherein the first anatomical location is disposed immediately adjacent the second anatomical location.

14. A method of inducing a baroreceptor signal to affect a change in the baroreflex system in a patient, the method comprising the steps of:

providing a baroreceptor activation device;

positioning the baroreceptor activation device proximate a baroreceptor;

generating a control signal to activate, deactivate or otherwise modulate the baroreceptor activation device to induce a baroreceptor signal; and

changing the control signal to promote long term efficacy of inducing baroreceptor signals.

15. A method as in claim 14, wherein the baroreceptor activation device mechanically, electrically, thermally, chemically, or biologically induces the baroreceptor signal.

16. A method as in claim 15, wherein the baroreceptor activation device is activated, deactivated or otherwise modulated for a period of time having a start time and a duration, and wherein the start time and/or duration are changed to promote long term efficacy.

17. A method as in claim 16, wherein the start time is triggered by an event, and wherein the event is changed to promote long term efficacy.

18. A method as in claim 16, wherein the start time is triggered by an event with a delay between the event and the start time, and wherein the delay is changed to promote long term efficacy.

19. A method of inducing a baroreceptor signal to affect a change in the baroreflex system in a patient, the method comprising the steps of:

providing a baroreceptor activation device;

positioning the baroreceptor activation device proximate a baroreceptor;

generating an electrical signal from the baroreceptor activation device to electrically induce a baroreceptor signal; and

changing the electrical signal to promote long term efficacy of inducing baroreceptor signals.

20. A method as in claim 19, wherein the electrical signal has a frequency, and wherein the step of changing the electrical signal comprises changing the frequency.

21. A method as in claim 19, wherein the electrical signal has a voltage, and wherein the step of changing the electrical signal comprises changing the voltage.

22. A method as in claim 19, wherein the electrical signal has a polarity, and wherein the step of changing the electrical signal comprises changing the polarity.

23. A method as in claim 19, wherein the electrical signal has a waveform, and wherein the step of changing the electrical signal comprises changing the waveform.

24. A method as in claim 19, wherein the electrical signal has a phase, and wherein the step of changing the electrical signal comprises changing the phase.

25. A system for inducing a baroreceptor signal to affect a change in the baroreflex system in a patient, the system comprising:

a baroreceptor activation device positioned proximate a baroreceptor such that activation of the baroreceptor activation device induces a baroreceptor signal; and

a control system connected to the baroreceptor activation device, the control system including a processor and a memory, wherein the memory includes software defining a stimulus regimen, the control system generating a control signal as a function of the stimulus regimen, the stimulus regimen causing a change in the control signal to promote long term efficacy of inducing baroreceptor signals.