Stimulus regimens for cardiovascular reflex control

• US 7,623,926 B2
• Filed: 04/05/2004
• Issued: 11/24/2009
• Est. Priority Date: 09/27/2000
• Status: Expired due to Term

• Current Assignee: CVRx, Inc.
• Original Assignee: CVRx, Inc.
• Inventors: Serdar, David J., Persson, Bruce J., Rossing, Martin A., Kieval, Robert S.
• Primary Examiner(s): Layno; Carl H.
• Assistant Examiner(s): Heller; Tammie K.
• Application Number:
  US10/818,738
• Publication Number:
  US 20040254616A1
• Time in Patent Office: 2,059 Days
• Field of Search: 607/44, 607 68- 70, 607 72- 74, 607/59
• 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

Baroreflex activation is achieved by providing suitable control signals to a baroreflex activation device. A method comprises establishing a therapy interval (possibly on the order of minutes to hours, or possibly of indefinite duration), within the therapy interval, establishing a plurality of dose intervals, and generating an electrical output signal. The electrical output signal has a time dependence such that the average electrical power applied to the baroreflex activation device differs between first and second portions of at least some dose intervals. Another method comprises establishing a series of therapy interval portions, during at least some therapy intervals, establishing a plurality of burst intervals (perhaps having durations commensurate with an interval between heartbeats), and generating an electrical output signal. The electrical output signal has a time dependence such that the average electrical power applied to the baroreflex activation device differs between first and second portions of the therapy intervals and also differs between first and second portions of at least some burst intervals.

Claims

1. A method of controlling a baroreflex activation device for the treatment of hypertension, the method comprising:

implanting the baroreflex activation device on or within a blood vessel proximate one or more baroreceptors, the baroreflex activation device including at least one electrode configured to deliver therapy to the one or more baroreceptors based on a control signal;

providing a controller coupled to the baroreflex activation device; and

using the controller to generate the control signal based on a therapy interval defined by a plurality of burst intervals each defined by a series of electrical pulses and including a first burst portion and a second burst portion each having a burst average power defined by a number of electrical pulses delivered over a period less than or equal to that burst portion, wherein the therapy interval includes a first therapy portion and a second therapy portion each having a therapy average power defined by a number of electrical pulses delivered over a period at least equal to a plurality of burst intervals, wherein the burst average power of the first burst portion is different than the burst average power of the second burst portion and wherein the therapy average power of the first therapy portion is different than the therapy average power of the second therapy portion.

2. The method of claim 1, wherein the first therapy portion is at least partly characterized by an initial increase in the therapy average power followed by a generally constant therapy average power followed by a decrease in therapy average power.

3. The method of claim 1, wherein each electrical pulse in the series of electrical pulses is substantially identical.

4. The method of claim 3, wherein each electrical pulse has identical pulse amplitudes and identical pulse widths.

5. The method of claim 1, wherein the burst average power of the first burst portion is greater than the burst average power of the second burst portion and wherein the therapy average power of the first therapy portion is greater than the therapy average power of the second therapy portion.

6. The method of claim 1, wherein the therapy interval is further defined by a plurality of dose intervals, each dose interval defined by a plurality of burst intervals and each dose interval having a first dose portion and a second dose portion each having a dose average power defined by a number of electrical pulses delivered over a period less than or equal to that dose portion, and wherein the therapy average power is further defined by a number of electrical pulses delivered over a period at least equal to a plurality of dose intervals.

7. The method of claim 6, wherein the first dose portion is at least partly characterized by an initial increase in the dose average power followed by a generally constant dose average power followed by a decrease in dose average power.

8. The method of claim 6 wherein any of the therapy interval, dose interval, or burst interval are triggered by a signal having a correlation with a physiologic response that is characterized by a time interval longer than a cardiac cycle.

9. The method of claim 8 wherein the physiologic response is respiration.

10. The method of claim 8 wherein the physiologic response is one or more of inspiration and expiration.

11. The method of claim 6 wherein the therapy interval is further defined by a variation in average power over a plurality of dose intervals.

12. The method of claim 1 wherein the therapy interval is on the order of minutes to hours.

13. The method of claim 1 wherein the therapy interval is of an indefinite duration.

14. The method of claim 1, wherein the burst interval is on the order of a cardiac cycle.

15. The method of claim 1, wherein the second therapy portion average power is zero.

16. The method of claim 1, wherein the baroreflex activation device includes a second electrode configured to deliver therapy to the one or more baroreceptors based on the control signal, the method further comprising interleaving the control signal between the first electrode and the second electrode.

17. The method of claim 16, further comprising interleaving the control signal between the first electrode and the second electrode at the individual pulse level.

18. The method of claim 16, further comprising interleaving the control signal between the first electrode and the second electrode at the burst level.

19. The method of claim 16, further comprising interleaving the control signal between the first electrode and the second electrode at the therapy level.

20. A method, comprising:

providing a baroreflex activation device including at least one electrode configured to deliver therapy to one or more baroreceptors based on a control signal;

providing a controller coupled to the baroreflex activation device; and

providing instructions for controlling the baroreflex activation device for the treatment of hypertension, the instructions comprising;

implanting the baroreflex activation device on or within a blood vessel proximate one or more baroreceptors;

generating the control signal with the controller based on a therapy interval defined by a plurality of burst intervals each defined by a series of electrical pulses and including a first burst portion and a second burst portion each having a burst average power defined by a number of electrical pulses delivered over a period less than or equal to that burst portion, wherein the therapy interval includes a first therapy portion and a second therapy portion each having a therapy average power defined by a number of electrical pulses delivered over a period at least equal to a plurality of burst intervals, wherein the burst average power of the first burst portion is different than the burst average power of the second burst portion and wherein the therapy average power of the first therapy portion is different than the therapy average power of the second therapy portion.