Method and apparatus for using heart rate variability as a safety check in electrical therapies

• US 7,672,725 B2
• Filed: 01/18/2005
• Issued: 03/02/2010
• Est. Priority Date: 01/18/2005
• Status: Expired due to Fees

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Carlson, Gerrard M., Pastore, Joseph M., Yu, Yinghong, Ding, Jiang, Kramer, Andrew P., Salo, Rodney W.
• Primary Examiner(s): BOCKELMAN, MARK
• Application Number:
  US11/037,309
• Publication Number:
  US 20060161209A1
• Time in Patent Office: 1,869 Days
• Field of Search: 607/4, 607/5, 607/9, 607 14- 15, 607 27- 28, 607/17, 607/19, 600/510
• US Class Current: 607/19
• CPC Class Codes: A61N 1/365 controlled by a physiological parameter, e.g. heart potential evoked response A61N1/371
• CPC Class Codes: A61N 1/36592 controlled by the heart rate variability

Abstract

A cardiac rhythm management system modulates the delivery of pacing and/or autonomic neurostimulation pulses based on heart rate variability (HRV). An HRV parameter being a measure of the HRV is produced to indicate a patient'"'"'s cardiac condition, based on which the delivery of pacing and/or autonomic neurostimulation pulses is started, stopped, adjusted, or optimized. In one embodiment, the HRV parameter is used as a safety check to stop an electrical therapy when it is believed to be potentially harmful to continue the therapy.

Claims

1. A cardiac rhythm management system, comprising:

a sensing circuit to sense a cardiac signal;

a heart rate variability (HRV) measurement circuit, coupled to the sensing circuit, to measure an HRV being a variance in cardiac cycle lengths over a predetermined period of time based on the sensed cardiac signal and to produce an HRV parameter representing the measured HRV;

a pacing output circuit to deliver pacing pulses; and

a stimulation control circuit coupled to the sensing circuit, the HRV measurement circuit, and the pacing output circuit, the stimulation control circuit including;

a stimulation algorithm execution module to control the delivery of the pacing pulses by executing at least a first stimulation algorithm, the stimulation algorithm execution module adapted to control the delivery of the pacing pulses by executing one of a cardiac resynchronization therapy (CRT) pacing algorithm and a remodeling control therapy (RCT) pacing algorithm; and

a safety check module adapted to dynamically adjust a first safety threshold using an indication, estimation, or prediction of an activity level and including;

a comparator adapted to compare the HRV parameter to the first safety threshold; and

a switch circuit adapted to stop the execution of the RCT pacing algorithm and start the execution of the CRT pacing algorithm when the HRV parameter falls below the first safety threshold.

2. The system of claim 1, wherein the sensing circuit comprises an electrogram sensing circuit to sense one or more electrograms.

3. The system of claim 2, wherein the stimulation algorithm execution module comprises a bradycardia pacing algorithm execution module to control the delivery of the pacing pulses by executing a bradycardia pacing algorithm.

4. The system of claim 1, wherein the sensing circuit comprises an electrogram sensing circuit to sense one or more electrograms and a neural signal sensing circuit to sense one or more autonomic neural signals, and further comprising a neurostimulation output circuit to deliver neurostimulation pulses.

5. The system of claim 4, wherein the stimulation algorithm execution module comprises a neurostimulation algorithm execution module to control the delivery of the neurostimulation pulses by executing a first neurostimulation algorithm.

6. The system of claim 1, wherein the safety check module is adapted to dynamically adjust the first safety threshold based on a heart rate.

7. The system of claim 1, wherein the comparator is adapted to compare the HRV parameter to the first safety threshold and a second safety threshold, and the switch circuit is adapted to resume the execution of the RCT pacing algorithm and stop the execution of the CRT pacing algorithm when the HRV parameter exceeds the second safety threshold.

8. The system of claim 7, wherein the first safety threshold and the second safety threshold are equal.

9. The system of claim 7, wherein the first safety threshold and the second safety threshold are different.

10. The system of claim 1, wherein the HRV measurement circuit is adapted to produce a plurality of HRV parameters selected from a Standard Deviation of Normal-to-Normal intervals (SDNN), a Standard Deviation of Averages of Normal-to-Normal intervals (SDANN), an HRV footprint a Root-Mean-Square of Successive Differences (RMSSD);

and a Ratio of Low Frequency HRV to High Frequency HRV ratio (LF/HF ratio).

11. The system of claim 1, wherein the HRV measurement circuit is adapted to produce a Ratio of Low Frequency HRV to High Frequency HRV ratio (LF/HF ratio).

12. The system of claim 1, comprising an implantable medical device including the sensing circuit, the HRV measurement circuit, the pulse output circuit, and the stimulation control circuit.

13. The system of claim 1, wherein the HRV measurement circuit is adapted to produce a Standard Deviation of Normal-to-Normal intervals (SDNN).

14. The system of claim 1, wherein the HRV measurement circuit is adapted to produce a Standard Deviation of Averages of Normal-to-Normal intervals (SDANN).

15. The system of claim 1, wherein the HRV measurement circuit is adapted to produce an HRV footprint.

16. The system of claim 1, wherein the HRV measurement circuit is adapted to produce a Root-Mean-Square of Successive Differences (RMSSD).

17. The system of claim 1, wherein the safety check module is adapted to dynamically adjust the first safety threshold based on an anticipated activity level during specific times of each day.