IP Library Granted Patent US 11,628,301
Granted Patent B2
US 11,628,301 · App. 17/054,996 · Granted Apr 18, 2023

Display signal to assess autonomic response to vagus nerve stimulation treatment

Inventors: Imad Libbus (St. Paul, MN); Scott R. Stubbs (Maple Grove, MN); Scott Mazar (Woodbury, MN); Bruce KenKnight (Maple Grove, MN); Badri Amurthur (Los Gatos, CA)
Assignee: LivaNova USA, Inc.
A61N1/36114A61N1/36139A61N1/36175A61N1/37247
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Quick Facts
Patent No.
US 11,628,301
App. No.
17/054,996
Granted
Apr 18, 2023
Kind
B2
Abstract

An assessment system is provided for vagus nerve stimulation therapy treatment for congestive heart failure in a subject. The assessment system includes a first interface configured to communicate with a device that delivers a stimulation signal to a vagus nerve of the subject, a second interface configured to capture heart electrical activity of the subject in response to the stimulation signal, and a processor and a non-transitory computer readable memory storing instructions that, when executed by the processor, cause the assessment system to determine and display heart rate dynamics and display a digital ECG signal in real-time in response to the stimulation signal.

Claims (49)

1. An assessment system for vagus nerve stimulation therapy treatment for congestive heart failure in a subject, the assessment system comprising:

a first interface configured to communicate with a device that delivers a stimulation signal to a vagus nerve of the subject;

a second interface configured to capture heart electrical activity of the subject in response to the stimulation signal; and

a processor and a non-transitory computer readable memory storing instructions that, when executed by the processor, cause the assessment system to:

segregate the captured heart electrical activity into portions that correspond to at least one ON-period of the stimulation signal and at least one OFF-period of the stimulation signal based on a communication between the first interface and the device that delivers the stimulation signal; and

determine and display real-time heart rate dynamics for each of the at least one ON-period and the at least one OFF-period and display a digital ECG signal in real-time in response to the stimulation signal.

2. The system of claim 1 , wherein the instructions further cause the assessment system to:

determine the real-time heart rate dynamics and display the digital ECG signal for a plurality of cycles of stimulation signal delivery, each cycle defined by an ON-period and an OFF-period of the stimulation signal; and

provide an indication of autonomic engagement of the subject within 20 cycles.

3. The system of claim 2 , wherein the instructions cause the assessment system to provide the indication of the autonomic engagement within 10 cycles.

4. The system of claim 3 , wherein the instructions cause the assessment system to provide the indication of the autonomic engagement within 5 cycles.

5. The system of claim 4 , wherein the instructions cause the assessment system to provide the indication of the autonomic engagement in real-time.

6. The system of claim 1 , wherein the instructions cause the assessment system to:

record an ECG waveform signal from the captured heart electrical activity and synchronize recording of the ECG waveform signal with a timing of the stimulation signal delivery;

generate and display a plurality of QRS complexes from the ECG waveform signal;

identify a differential in the QRS complexes between ON-periods in which the stimulation signal is delivered as compared to OFF-periods in which the stimulation signal is not delivered; and

display the differential as indicating autonomic engagement.

7. The system of claim 6 , wherein the differential is a comparison of R-R intervals of the QRS complexes for the ON-periods as compared to the OFF-periods.

8. The system of claim 1 , wherein the instructions further cause the assessment system to record and display a waveform of the digital ECG signal response in real-time from the heart electrical activity captured by the second interface; and

wherein the displayed real-time heart rate dynamics include at least one of a real-time heart rate, a first average heart rate for ON-periods in which the stimulation signal is delivered, a second average heart rate for OFF-periods in which the stimulation signal is not delivered, or a difference between the second and the first average heart rates.

9. The system of claim 1 , wherein the display of the real-time heart rate dynamics and the digital ECG signal can be archived and played back.

10. The system of claim 1 , wherein the first interface communicates an ON-period during which stimulation is being delivered and an OFF-period during which no stimulation is being delivered; and

wherein the instructions further cause the assessment system to determine and indicate the stimulation signal delivery including the ON- and OFF-periods.

11. The system of claim 1 , wherein the display of the real-time heart rate dynamics and the digital ECG signal is dynamic.

12. The system of claim 11 , wherein a display playback speed can be controlled.

13. A titration assessment system for vagus nerve stimulation therapy treatment in a subject, the titration assessment system comprising:

an ECG cable assembly configured to acquire an ECG signal response in the subject;

a VNS titration assembly configured to deliver a periodic stimulation signal having ON-periods and OFF-periods;

a data acquisition system coupled to the ECG cable assembly and configured to capture the ECG signal response and detect delivery of the stimulation signal; and

a processor and a non-transitory computer readable memory storing instructions that, when executed by the processor, cause the titration assessment system to:

segregate the ECG signal response to the stimulation signal into portions that correspond to at least one ON-period of the ON-periods and at least one OFF-period of the OFF-periods based on the data acquisition system detecting the delivery of the stimulation signal;

process the ECG signal response to determine R-R intervals in the ECG signal response corresponding to the ON-periods and the OFF-periods;

determine and display real-time heart rate dynamics for each of the at least one ON-period and the at least one OFF-period; and

digitally reproduce the ECG signal response for display.

14. The system of claim 13 , wherein the VNS titration assembly includes an implantable stimulation device and a wand configured to wirelessly interface with the implantable stimulation device.

15. The system of claim 14 , wherein the implantable stimulation device includes an implantable cardioverter-defibrillator (ICD).

16. A method of assessing a vagus nerve stimulation treatment for a subject comprising:

segregating an ECG signal response to the vagus nerve stimulation treatment into portions that correspond to at least one ON-period of a stimulation signal and at least one OFF-period of the stimulation signal based on a communication between a first interface and a device that delivers the stimulation signal;

determining and displaying real-time heart rate dynamics in the ECG signal response for a plurality of cycles of stimulation signal delivery, each cycle defined by an ON-period and an OFF-period of the stimulation signal;

digitally displaying the ECG signal response in real-time; and

providing an indication of autonomic engagement of the subject within 20 cycles, the indication of autonomic engagement being based on the real-time heart rate dynamics for the at least one ON-period and the at least one OFF-period.

17. The method of claim 16 , wherein providing the indication of the autonomic engagement comprises providing the indication of the autonomic engagement within 10 cycles.

18. The method of claim 16 , wherein providing the indication of the autonomic engagement comprises providing the indication of the autonomic engagement within 5 cycles.

19. The method of claim 16 , wherein providing the indication of the autonomic engagement comprises providing the indication of the autonomic engagement in real-time.

20. The method of claim 16 , further comprising:

recording an ECG waveform signal from the ECG signal response and synchronizing recording of the ECG waveform signal with a timing of the stimulation signal delivery;

generating and displaying a plurality of QRS complexes from the ECG waveform signal;

identifying a differential in the QRS complexes between the ON-periods as compared to the OFF-periods; and

displaying the differential as indicating autonomic engagement.

Assignments (2)
SECURITY INTEREST Recorded Aug 16, 2021
From: LIVANOVA USA, INC.
To: GOLDMAN SACHS BANK USA, AS COLLATERAL AGENT
Reel/Frame 057188/0001 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 17, 2021
From: LIBBUS, IMAD; STUBBS, SCOTT R.; MAZAR, SCOTT; KENKNIGHT, BRUCE; AMURTHUR, BADRI
To: LIVANOVA USA, INC.
Reel/Frame 055292/0688 →
Continuity (2)
Provisional Application 62672011 · May 15, 2018
Related Publication 20210213291A1 · Jul 15, 2021