Evaluation of vagus nerve stimulation using heart rate variability analysis

Patent metadata

Field	Value
Publication number	US-2023146182-A1
Application number	US-202318092716-A
Country	US
Kind code	A1
Filing date	Jan 3, 2023
Priority date	May 25, 2018
Publication date	May 11, 2023
Grant date	—

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 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.

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

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

• A61B5/4836

  Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence) · CPC title

• A61N1/36139

  with automatic adjustment · CPC title

• A61N1/3616

  Voltage density or current density · CPC title

• A61N1/36196

  Frequency modulation · CPC title

• A61B5/02405

  Determining heart rate variability · CPC title