APPLICATIONS OF HEART RATE VARIABILITY ANALYSIS IN ELECTROTHERAPY AFFECTING AUTONOMIC NERVOUS SYSTEM RESPONSE

• US 20080009917A1
• Filed: 05/21/2007
• Published: 01/10/2008
• Est. Priority Date: 05/19/2006
• Status: Abandoned Application

• Current Assignee: CVRx, Inc.
• Original Assignee: CVRx, Inc.
• Inventors: Kieval, Robert, Erwin, Eric, Braginisky, Vadim, Pedersen, Brad, Rossing, Martin
• Application Number:
  US11/751,574
• Publication Number:
  US 20080009917A1
• Time in Patent Office: Days
• US Class Current: 607/044
• CPC Class Codes: A61B 5/02405 Determining heart rate variability
• CPC Class Codes: A61B 5/4035 Evaluating the autonomic nervous system
• CPC Class Codes: A61B 5/4052 efferent nerves, i.e. nerves that relay impulses from the central nervous system
• 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: G16H 20/30 relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising

Abstract

A method of operating a baroreflex therapy system includes providing an implantable baroreflex activation device, providing a sensing arrangement, and providing a controller in operable communication with the baroreflex activation device and the sensing arrangement. The sensing arrangement is used to measure a physical parameter of a patient to generate physical parameter data. The physical parameter data is communicated to the controller, wherein the controller performs heart rate variability analysis based on the physical parameter data. An indication of results of the heart rate variability analysis are provided, upon which a determination may be made to adjust a baroreflex therapy to be delivered by the implantable baroreflex activation device.

Claims

1. A method of operating a baroreflex therapy system, comprising:

providing an implantable baroreflex activation device;

providing a sensing arrangement;

providing a controller in operable communication with the baroreflex activation device and the sensing arrangement;

measuring a physical parameter of a patient with the sensing arrangement to generate physical parameter data;

communicating the physical parameter data to the controller;

performing heart rate variability analysis with the controller based on the physical parameter data; and

providing an indication of results of the heart rate variability analysis upon which a determination may be made to adjust a baroreflex therapy to be delivered by the implantable baroreflex activation device.

2. The method of claim 1, wherein providing an indication of the results of the heart rate variability analysis is selected from the group consisting of:

communicating the results to a physician interface device, and communicating the indication to the implantable baroreflex activation device.

3. The method of claim 1, wherein the controller is configured with a desired performance target range, further comprising:

comparing the results of the heart rate variability analysis to the desired performance target range; and

automatically adjusting the baroreflex therapy with the controller if the results of the heart rate variability analysis are outside of the desired performance range.

4. The method of claim 1, wherein the target performance range is set by a physician.

5. The method of claim 1, further comprising:

sensing cardiac electrical activity associated with heart rate to generate cardiac electrical activity data;

communicating the cardiac electrical activity data to the controller; and

providing an indication of the cardiac electrical activity data and results of the heart rate variability analysis, upon which a determination may be made to adjust the baroreflex therapy to be delivered by the baroreflex activation device.

6. A system for providing a baroreflex therapy, comprising:

a baroreflex activation device;

a sensing arrangement adapted to collect physical parameter data; and

a controller in communication with the device and the sensing arrangement, wherein the controller is adapted to receive the physical parameter data from the sensing arrangement, perform heart rate variability analysis of the physical parameter data, and provide an indication of results of the heart rate variability analysis upon which a determination may be made to adjust a baroreflex therapy to be delivered by the baroreflex activation device.

7. The system of claim 6, further comprising a physician interface device communicatively coupled to the controller and configured to communicate the results of the heart rate variability analysis to a physician.

8. The system of claim 6, wherein the controller includes a desired performance target range, the results of the heart rate variability analysis are compared to the desired performance target range, and the controller is adapted to automatically adjust the baroreflex therapy if the results of the heart rate variability analysis are outside of the desired performance target range.

9. The system of claim 6, wherein the sensing arrangement includes an additional sensor adapted to sense cardiac electrical activity associated with heart rate to generate cardiac electrical data, the cardiac electrical activity data communicated to the controller for providing an indication of the cardiac electrical activity data and results of the heart rate variability analysis, upon which a determination may be made to adjust the baroreflex therapy to be delivered by the baroreflex activation device.

10. A system for providing a baroreflex therapy, comprising:

a baroreflex activation device;

means for sensing a physical parameter of a patient, adapted to collect physical parameter data; and

means for controlling the system in communication with the device and the means for sensing a physical parameter, wherein the means for controlling is adapted to receive the physical parameter data from the means for sensing, perform a heart rate variability analysis of the physical parameter data, and provide an indication of results of the heart rate variability analysis upon which a determination may be made to adjust a baroreflex therapy to be delivered by the baroreflex activation device.

11. The system of claim 10, further comprising a means for communicating the results of the heart rate variability analysis to a physician.

12. The system of claim 10, wherein the means for controlling includes a desired performance target range, the results of the heart rate variability analysis are compared to the desired performance target range, and the means for controlling is adapted to automatically adjust the baroreflex therapy if the results of the heart rate variability analysis are outside of the desired performance target range.

13. The system of claim 10, wherein the means for sensing is adapted to sense electrical cardiac activity associated with heart rate to generate electrical cardiac activity data, wherein the electrical cardiac activity data is communicated to the controller to provide an indication of the electrical cardiac activity data and results of the heart rate variability analysis upon which a determination may be made to adjust the baroreflex therapy to be delivered by the baroreflex activation device.

14. A method, comprising:

providing an implantable baroreflex activation device;

providing a sensing arrangement;

providing a controller operably communicable with the baroreflex activation device and the sensing arrangement; and

providing instructions for operating the device, comprising;

measuring a physical parameter of a patient with the sensing arrangement to generate physical parameter data;

communicating the physical parameter data to the controller;

performing heart rate variability analysis with the controller based on the physical parameter data; and

providing an indication of the results of the heart rate variability analysis to determine an effect on the autonomic nervous system of a patient, upon which a determination may be made to adjust a baroreflex therapy to be delivered by the implantable baroreflex activation device.

15. The method of claim 14, wherein the heart rate variability analysis is used to distinguish a sympathetic nervous system response to the baroreflex therapy from a parasympathetic nervous system response to the baroreflex therapy.

16. The method of claim 14, wherein the baroreflex therapy is adjusted in response to the results of the heart rate variability analysis to increase and/or suppress an effect on the autonomic nervous system.

17. The method of claim 14, wherein the controller is configured with a desired performance target range of an autonomic nervous system response, further comprising:

comparing the results of the heart rate variability analysis to the desired performance target range; and

automatically adjusting the baroreflex therapy with the controller if the results of the heart rate variability analysis are outside of the desired performance range.

18. The method of claim 14, wherein the baroreflex therapy is adjusted in response to the results of the heart rate variability analysis to increase an enhancement effect on the parasympathetic nervous system of the patient.

19. The method of claim 14, wherein the baroreflex therapy is adjusted in response to the results of the heart rate variability analysis to increase a suppressive effect on the sympathetic nervous system of the patient.

20. The method of claim 14, wherein providing an indication of the results of the heart rate variability analysis is selected from the group consisting of:

communicating the results to a physician interface device, and communicating the results to the implantable baroreflex activation device.

21. A baroreflex therapy system, comprising:

an implantable baroreflex activation device;

a sensing arrangement;

a controller in operable communication with the baroreflex activation device and the sensing arrangement; and

instructions recorded on a tangible medium for operating the device, comprising;

measuring a physical parameter of a patient with the sensing arrangement to generate physical parameter data;

communicating the physical parameter data to the controller;

performing heart rate variability analysis with the controller based on physical parameter data; and

providing an indication of the heart rate variability analysis upon which a determination may be made to adjust a baroreflex therapy to be delivered by the implantable baroreflex activation device.

22. The system of claim 21, wherein providing an indication of the results of the heart rate variability analysis is selected from the group consisting of:

communicating the results to a physician interface device, and communicating the results to the implantable baroreflex activation device.

23. The system of claim 21, wherein the controller is configured with a desired performance target range, further comprising:

comparing the results of the heart rate variability analysis to the desired performance target range; and

automatically adjusting the baroreflex therapy with the controller if the results of the heart rate variability analysis are outside of the desired performance range.

24. The system of claim 21, further comprising:

measuring cardiac electrical activity with the measuring arrangement to generate cardiac electrical activity data;

combining the cardiac electrical activity data and the heart rate variability analysis upon which a determination may be made to adjust the therapy.

25. The system of claim 21, wherein the sensing arrangement is selected from the group consisting of:

at least one sensor integrated with the implantable baroreflex activation device,

at least one sensor separate from the implantable baroreflex activation device,

a second implantable medical device that is capable of delivering cardiac rhythm management, and

a sensor integrated with the baroreflex activation device, the device also capable of delivering cardiac rhythm management.