Baroreflex activation therapy with incrementally changing intensity

• US 8,594,794 B2
• Filed: 07/17/2008
• Issued: 11/26/2013
• Est. Priority Date: 07/24/2007
• Status: Active Grant

• Current Assignee: CVRx, Inc.
• Original Assignee: CVRx, Inc.
• Inventors: Kieval, Robert S., Lovett, Eric Grant, Covalin, Alejandro
• Primary Examiner(s): BOCKELMAN, MARK
• Application Number:
  US12/175,415
• Publication Number:
  US 20090030478A1
• Time in Patent Office: 1,958 Days
• Field of Search: 607/2, 607/44
• US Class Current: 607/44
• 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

Abstract

The present invention provides systems, devices, and methods for using the same for activating (stimulating) the baroreflex system of a patient using a baroreflex activation system with incrementally changing therapy intensity by sensing/monitoring/interpreting sensed data.

Claims

1. A method for treating a patient, comprising:

activating a baroreflex system of the patient with a baroreflex activation device according to a baroreflex activation therapy, the therapy stored within a control system coupled to the baroreflex activation device;

establishing an initial target value for a physiological parameter of the patient;

monitoring the physiological parameter;

using the control system to determine whether the value of the physiological parameter has changed and if so, automatically performing the following steps with the control system;

determining whether the value of the physiological parameter has increased or decreased as compared to the initial target value of the physiological parameter;

determining a magnitude of the change of the physiological parameter; and

determining a rate of change of the physiological parameter over a period of time; and

adjusting the baroreflex activation therapy in response to at least one of the magnitude of the change of the monitored parameter or the rate of change of the monitored physiological parameter.

2. The method of claim 1, wherein the magnitude of a change for the physiological parameter affects adjusting of the baroreflex activation therapy.

3. The method of claim 2, wherein if an increase in the magnitude of the monitored physiological parameter is determined to be a member of a class of large changes, then the baroreflex activation therapy is increased by a predetermined large step-size associated with large changes in the monitored physiologic parameter.

4. The method of claim 2, wherein if an increase in the magnitude of the monitored physiological parameter is determined to be a member of a class of small changes, then the baroreflex activation therapy is increased by a predetermined small step-size associated with small changes in the monitored physiologic parameter.

5. The method of claim 2, wherein if a decrease in the magnitude of the monitored physiological parameter is determined to be a member of a class of large changes, then the baroreflex activation therapy is decreased by a predetermined large step-size associated with large changes in the monitored physiologic parameter.

6. The method of claim 2, wherein if a decrease in the magnitude of the monitored physiological parameter is determined to be a member of a class of small changes, then the baroreflex activation therapy is decreased by a predetermined small step-size associated with small changes in the monitored physiologic parameter.

7. The method of claim 1, further comprising determining a baroreflex activation therapy intensity step size associated with a class of change in the monitored physiological parameter magnitude.

8. The method of claim 7, further comprising creating a classification system based on data collected regarding the magnitudes of the monitored physiological parameter monitored over time.

18. The method of claim 1, further comprising:

classifying the rate of change of the parameter; and

adjusting the baroreflex activation therapy by a prescribed therapy intensity step-size based on the classification of the rate of change of the parameter.

9. A method for treating a patient, comprising:

identifying a parameter indicative of a physiological condition of the patient;

establishing an initial target value for the parameter;

establishing a baroreflex activation therapy comprising a plurality of prescribed intensity step-sizes, each intensity step-size being associated with a predetermined class of parameter change rate;

activating a baroreflex system of the patient with a baroreflex activation device according to the baroreflex activation therapy at a pre-determined intensity;

monitoring the parameter;

determining whether the value of the parameter has changed and if so, performing the following steps;

determining whether the value of the parameter has increased or decreased as compared to the initial target value of the parameter;

determining a magnitude of the change of the parameter; and

determining a rate of change for the parameter; and

adjusting the baroreflex activation therapy in response to at least one of the magnitude of the change of the monitored parameter or the rate of change in the class of the monitored parameter.

10. The method of claim 9, wherein if there has been no change to the value of the parameter, baroreflex activation therapy continues.

11. The method of claim 9, wherein adjusting the baroreflex activation therapy is proportional to the change in the monitored parameter.

12. The method of claim 9, wherein adjusting in the baroreflex activation therapy is unproportional to the change in the monitored parameter.

13. The method of claim 9, wherein the intensity is changed based on a prescribed step-size intensity commensurate with the magnitude of change of the parameter and rate of change of the parameter.

14. The method of claim 9, wherein if the magnitude of the parameter has increased at a large rate, then the baroreflex activation therapy intensity is increased according to the prescribed step-sized intensity commensurate with a class of large rates of change for the parameter.

15. The method of claim 9, wherein if the magnitude of the parameter has increased at a small rate, then the baroreflex activation therapy intensity is increased according to the prescribed step-sized intensity commensurate with a class of small rates of change for the parameter.

16. The method of claim 9, wherein if the magnitude of the parameter has decrease at a large rate, then the baroreflex activation therapy intensity is decreased according to the prescribed step-sized intensity commensurate with a class of large rates of change for the parameter.

17. The method of claim 9, wherein if the magnitude of the parameter has decreased at a small rate, then the baroreflex activation therapy intensity is decreased according to the prescribed step-sized intensity commensurate with a class of small rates of change for the parameter.

19. The method of claim 9, further comprising:

classifying the rate of change of the parameter; and

adjusting the baroreflex activation therapy by the prescribed therapy intensity step-size based on the classification of the rate of change of the parameter.