Evaluation of vagus nerve stimulation using heart rate variability analysis

Patent metadata

Field	Value
Publication number	US-11980758-B2
Application number	US-202318092716-A
Country	US
Kind code	B2
Filing date	Jan 3, 2023
Priority date	May 25, 2018
Publication date	May 14, 2024
Grant date	May 14, 2024

Abstract

An implantable vagus nerve stimulation (VNS) system includes a sensor configured to measure ECG data for a patient, a stimulation subsystem configured to deliver VNS to the patient, and a control system configured to perform a heart rate variability analysis with the ECG data. In some aspects, performing the heart rate variability analysis includes measuring R-R intervals between successive R-waves for the ECG data measured during a stimulation period of VNS therapy and a baseline period of the VNS therapy, wherein the stimulation period comprises at least a portion of the ON period and the baseline period comprises at least a portion of the OFF period immediately preceding the ON period, and generating a plot of each R-R interval against an immediately successive R-R interval for each of the stimulation period and the baseline period configured to be displayed on a display.

First claim

What is claimed is:

1. An implantable vagus nerve stimulation (VNS) system, comprising:
a sensor configured to measure ECG data for a patient;
a stimulation subsystem comprising a pulse generator and at least one stimulating nerve electrode configured to deliver VNS therapy to the patient, wherein the VNS therapy is delivered according to a duty cycle comprising an ON period during which a VNS dose is applied and an OFF period during which the VNS dose is suspended; and
a control system comprising a processor configured to perform a heart rate variability analysis with the ECG data by:
measuring R-R intervals between successive R-waves for the ECG data measured during a stimulation period of the VNS therapy and a baseline period of the VNS therapy, wherein the stimulation period comprises at least a portion of the ON period and the baseline period comprises only a portion of the OFF period immediately preceding the ON period; and
generating a plot of each R-R interval against an immediately successive R-R interval for each of the stimulation period and the baseline period configured to be displayed on a display.

2. The implantable VNS system of claim 1 , wherein the heart rate variability analysis is a Poincare analysis.

3. The implantable VNS system of claim 1 , wherein the control system is further configured to perform the heart rate variability analysis by determining, based on the plot, a standard deviation from an axis of a line perpendicular to an identity line for each of the stimulation period plot and the baseline period plot.

4. The implantable VNS system of claim 1 , wherein the at least a portion of the OFF period immediately preceding the ON period comprises a last five seconds of the OFF period immediately preceding the ON period.

5. The implantable VNS system of claim 1 , wherein the at least a portion of the ON period is immediately preceding the OFF period.

6. The implantable VNS system of claim 1 , wherein the control system is further configured to control the stimulation subsystem to increase the VNS dose delivered to the patient according to a titration schedule.

7. The implantable VNS system of claim 6 , wherein the control system is configured to perform the heart rate variability analysis in response to an increase in the VNS dose.

8. The implantable VNS system of claim 1 , wherein the heart rate variability analysis is a real-time heart rate variability analysis.

9. The implantable VNS system of claim 1 , wherein the control system is configured to prepare periodic reports for a physician of the patient based on the heart rate variability analysis.

10. A vagus nerve stimulation (VNS) system, comprising:
an external programmer comprising a processor; and
an implantable system comprising:
a sensor configured to measure ECG data for a patient and transmit the ECG data to the external programmer; and
a stimulation subsystem comprising a pulse generator and at least one stimulating nerve electrode configured to deliver VNS therapy to the patient, wherein the VNS therapy is delivered according to a duty cycle comprising an ON period during which a VNS dose is applied and an OFF period during which the VNS dose is suspended;
wherein the processor of the external programmer is configured to:
receive the ECG data from the implantable system; and
perform a heart rate variability analysis with the ECG data by:
measuring R-R intervals between successive R-waves for the ECG data measured during a stimulation period of the VNS therapy and a baseline period of the VNS therapy, wherein the stimulation period comprises at least a portion of the ON period and the baseline period comprises only a portion of the OFF period immediately preceding the ON period; and
generating a plot of each R-R interval against an immediately successive R-R interval for each of the stimulation period and the baseline period configured to be displayed on a display.

11. The VNS system of claim 10 , wherein the heart rate variability analysis is a Poincare analysis.

12. The VNS system of claim 10 , wherein the external programmer is further configured to perform the heart rate variability analysis by determining, based on the plot, a standard deviation from an axis of a line perpendicular to an identity line for each of the stimulation period plot and the baseline period plot.

13. The VNS system of claim 10 , wherein the at least a portion of the OFF period immediately preceding the ON period comprises a last five seconds of the OFF period immediately preceding the ON period.

14. The VNS system of claim 10 , wherein the at least a portion of the ON period is immediately preceding the OFF period.

15. The VNS system of claim 10 , wherein the external programmer is further configured to display the stimulation period plot and the baseline period plot on a display.

16. The VNS system of claim 10 , wherein the heart rate variability analysis is a real-time heart rate variability analysis.

17. A vagus nerve stimulation (VNS) system, comprising:
a local telemetry device comprising a processor; and
an implantable system, comprising:
a sensor configured to measure ECG data for a patient and transmit the ECG data to the local telemetry device; and
a stimulation subsystem comprising a pulse generator and at least one stimulating nerve electrode configured to deliver VNS therapy to the patient, wherein the VNS therapy is delivered according to a duty cycle comprising an ON period during which a VNS dose is applied and an OFF period during which the VNS dose is suspended;
wherein the processor of the local telemetry device is configured to:
receive the ECG data from the implantable system; and
perform a heart rate variability analysis with the ECG data by:
measuring R-R intervals between successive R-waves for the ECG data measured during a stimulation period of the VNS therapy and a baseline period of the VNS therapy, wherein the stimulation period comprises at least a portion of the ON period and the baseline period comprises only a portion of the OFF period immediately preceding the ON period; and
generating a plot of each R-R interval against an immediately preceding R-R interval for each of the stimulation period and the baseline period configured to be displayed on a display.

18. The VNS system of claim 17 , wherein the heart rate variability analysis is a Poincaré analysis.

19. The VNS system of claim 17 , wherein the local telemetry device is further configured to perform the heart rate variability analysis by determining, based on the plot, a standard deviation from an axis of a line perpendicular to an identity line for each of the stimulation period plot and the baseline period plot.

20. The VNS system of claim 17 , wherein the local telemetry device is configured to prepare periodic reports for a physician of the patient based on the heart rate variability analysis.

Assignees

• Livanova Usa Inc

Inventors

• Libbus Imad
• Nearing Bruce D
• Amurthur Badri
• Kenknight Bruce H
• Verrier Richard L

Classifications

• A61N1/36114 Primary

  Cardiac control, e.g. by vagal stimulation (stimulating the heart A61N1/362) · CPC title

• A61B5/02405

  Determining heart rate variability · CPC title

• A61N1/36139

  with automatic adjustment · CPC title

• A61B5/352

  Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval · CPC title

• A61B5/366

  Detecting abnormal QRS complex, e.g. widening · CPC title