IP Library Granted Patent US 11,633,600
Granted Patent B2
US 11,633,600 · App. 17/136,804 · Granted Apr 25, 2023

Titration assist system

Inventors: Imad Libbus (St. Paul, MN); Bruce KenKnight (Maple Grove, MN); Scott Stubbs (Maple Grove, MN); Scott Mazar (Maple Grove, MN)
Assignee: LivaNova USA, Inc.
A61N1/36114A61N1/36139A61N1/36175
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 11,633,600
App. No.
17/136,804
Granted
Apr 25, 2023
Kind
B2
Abstract

A neurostimulation system comprises a sensor and a control system. The sensor is configured to detect a cardiac physiological measure of a patient. The control system is programmed to monitor, via the sensor, the cardiac physiological measure during the treatment. The control system is further programmed to detect a change in the cardiac physiological measure during the treatment. The control system is further programmed to determine, based on the detected change in the cardiac physiological measure, a first transition time in a duty cycle of a neurostimulation signal delivered to the patient where the neurostimulation signal transitions between a stimulation OFF period and a stimulation ON period.

Claims (69)

1. A neurostimulation system comprising:

a sensor configured to detect a cardiac physiological measure of a patient;

a control system programmed to:

receive one or more stimulation timing parameters of a treatment;

monitor, via the sensor, the cardiac physiological measure during the treatment;

detect a first change and a second change in the cardiac physiological measure during the treatment;

compare a time period between the first change and the second change with the one or more stimulation timing parameters; and

determine, based on the comparison, a first transition time in a duty cycle of a neurostimulation signal delivered to the patient where the neurostimulation signal transitions between a stimulation OFF period and a stimulation ON period.

2. The neurostimulation system of claim 1 , wherein the one or more stimulation timing parameters comprise one or more of a stimulation ON period duration, a stimulation OFF period duration, or an overall stimulation cycle duration, and the control system is further programmed to:

determine the stimulation ON period and the stimulation OFF period based on the one or more stimulation timing parameters and the first transition time in the duty cycle where the neurostimulation signal transitions between the stimulation OFF period and the stimulation ON period.

3. The neurostimulation system of claim 2 , wherein the control system is further programmed to:

record the cardiac physiological measure during the stimulation ON period and the stimulation OFF period during the treatment at a first set of stimulation intensity parameters of the neurostimulation signal;

compare the cardiac physiological measure recorded during the stimulation ON period to the cardiac physiological measure recorded during the stimulation OFF period for the first set of stimulation intensity parameters; and

determine a first magnitude of stimulation-induced change of the cardiac physiological measure for the first set of stimulation intensity parameters based on the comparison of the cardiac physiological measure recorded during the stimulation ON period to the cardiac physiological measure recorded during the stimulation OFF period.

4. The neurostimulation system of claim 3 , wherein the control system is further programmed to:

determine a first degree of autonomic engagement for the first set of stimulation intensity parameters based on the first magnitude of stimulation-induced change;

determine that the first degree of autonomic engagement for the first set of stimulation intensity parameters is not within a neural fulcrum zone; and

responsive to the determination that the first degree of autonomic engagement is not within the neural fulcrum zone, identify a second set of stimulation intensity parameters of the neurostimulation signal based on the first degree of autonomic engagement, the second set of stimulation intensity parameters being different than the first set of stimulation intensity parameters.

5. The neurostimulation system of claim 1 , wherein the cardiac physiological measure is at least one of a heart rate, an R-R interval, a P-R interval, a Q-T interval, or a heart rate variability of the patient.

6. The neurostimulation system of claim 5 , wherein one of the first change or the second change in the cardiac physiological measure during the treatment is a reduction of the heart rate of between one and five beats per minute.

7. The neurostimulation system of claim 1 , further comprising an implantable medical device (IMD) configured to deliver the treatment to the patient, the IMD comprising a neurostimulator coupled to an electrode assembly, the neurostimulator including an implantable pulse generator configured to generate the neurostimulation signal delivered to the patient via the electrode assembly.

8. A method of delivering a neurostimulation signal to a patient from an implantable pulse generator, the method comprising:

receiving, by a control system, one or more stimulation timing parameters of a treatment;

delivering, by the implantable pulse generator, the neurostimulation signal to the patient via an electrode assembly, the neurostimulation signal having a duty cycle with a stimulation ON period and a stimulation OFF period;

detecting, by a sensor, a cardiac physiological measure of the patient;

monitoring, by the control system, the cardiac physiological measure during the treatment via the sensor;

detecting, by the control system, a first change and a second change in the cardiac physiological measure during the treatment;

comparing, by the control system, a time period between the first change and the second change with the one or more stimulation timing parameters; and

determining, by the control system based on the comparison, a first transition time in the duty cycle where the neurostimulation signal transitions between the stimulation OFF period and the stimulation ON period.

9. The method of claim 8 , wherein the one or more stimulation timing parameters comprise one or more of a stimulation ON period duration, a stimulation OFF period duration, or an overall stimulation cycle during, the method further comprising:

determining, by the control system, the stimulation ON period and the stimulation OFF period based on the one or more stimulation timing parameters and the first transition time in the duty cycle where the neurostimulation signal transitions between the stimulation OFF period and the stimulation ON period.

10. The method of claim 9 , further comprising:

recording, by the control system, the cardiac physiological measure during the stimulation ON period and the stimulation OFF period during the treatment at a first set of stimulation intensity parameters of the neurostimulation signal;

comparing, by the control system, the cardiac physiological measure recorded during the stimulation ON period to the cardiac physiological measure recorded during the stimulation OFF period for the first set of stimulation intensity parameters; and

determining, by the control system, a first magnitude of stimulation-induced change of the cardiac physiological measure for the first set of stimulation intensity parameters based on the comparison of the cardiac physiological measure recorded during the stimulation ON period to the cardiac physiological measure recorded during the stimulation OFF period.

11. The method of claim 10 , further comprising:

determining, by the control system, a first degree of autonomic engagement for the first set of stimulation intensity parameters based on the first magnitude of stimulation- induced change;

determining, by the control system, that the first degree of autonomic engagement for the first set of stimulation intensity parameters is not within a neural fulcrum zone; and

responsive to the determination that the first degree of autonomic engagement is not within the neural fulcrum zone, identifying, by the control system, a second set of stimulation intensity parameters of the neurostimulation signal based on the first degree of autonomic engagement, the second set of stimulation intensity parameters being different than the first set of stimulation intensity parameters.

12. The method of claim 11 , further comprising:

delivering, by the implantable pulse generator, the neurostimulation signal having the second set of stimulation intensity parameters to the patient via the electrode assembly;

recording, by the control system, the cardiac physiological measure during the stimulation ON period and the stimulation OFF period during the treatment at the second set of stimulation intensity parameters of the neurostimulation signal;

comparing, by the control system, the cardiac physiological measure recorded during the stimulation ON period to the cardiac physiological measure recorded during the stimulation OFF period for the second set of stimulation intensity parameters;

determining, by the control system, a second magnitude of stimulation-induced change of the cardiac physiological measure for the second set of stimulation intensity parameters based on the comparison of the cardiac physiological measure recorded during the stimulation ON period to the cardiac physiological measure recorded during the stimulation OFF period for the second set of stimulation intensity parameters;

determining, by the control system, a second degree of autonomic engagement for the second set of stimulation intensity parameters based on the second magnitude of stimulation-induced change; and

comparing, by the control system, the first degree of autonomic engagement to the second degree of autonomic engagement.

13. The method of claim 12 , wherein a plurality of degrees of autonomic engagements are determined iteratively for a plurality of sets of stimulation intensity parameters until a degree of autonomic engagement is within the neural fulcrum zone, the plurality of degrees of autonomic engagements including at least the first degree of autonomic engagement and the second degree of autonomic engagement, and the plurality of sets of stimulation intensity parameters including at least the first set of stimulation intensity parameters and the second set of stimulation intensity parameters.

14. The method of claim 8 , wherein the first transition time in the duty cycle is where the neurostimulation signal transitions from the stimulation OFF period to the stimulation ON period and the method further comprises:

determining, by the control system, a second transition time in the duty cycle where the neurostimulation signal transitions from the stimulation ON period to the stimulation OFF period based on the second change in the cardiac physiological measure.

15. The method of claim 8 , wherein the cardiac physiological measure is at least one of an R-R interval, a P-R interval, a Q-T interval, or a heart rate variability of the patient.

16. One or more non-transitory computer-readable mediums comprising instructions executable by one or more processors to:

receive one or more stimulation timing parameters of a treatment

detect, via a sensor, a cardiac physiological measure of a patient;

monitor, via the sensor, the cardiac physiological measure during the treatment

detect a first change and a second change in the cardiac physiological measure during the treatment;

compare a time period between the first change and the second change with the one or more stimulation timing parameters; and

determine, based on the comparison, a first transition time in a duty cycle of a neurostimulation signal delivered to the patient where the neurostimulation signal transitions between a stimulation OFF period and a stimulation ON period.

17. The one or more non-transitory computer-readable mediums of claim 16 , wherein the one or more stimulation timing parameters, comprise one or more of a stimulation ON period duration, a stimulation OFF period duration, or an overall stimulation cycle duration, and the instructions are further executable by the one or more processors to:

deliver, via an implantable pulse generator, the neurostimulation signal to the patient via an electrode assembly; and

determine the stimulation ON period and the stimulation OFF period based on the one or more stimulation timing parameters and the first transition time in the duty cycle where the neurostimulation signal transitions between the stimulation OFF period and the stimulation ON period.

18. The one or more non-transitory computer-readable mediums of claim 17 , wherein the instructions are further executable by the one or more processors to:

record the cardiac physiological measure during the stimulation ON period and the stimulation OFF period during the treatment at a first set of stimulation intensity parameters of the neurostimulation signal;

compare the cardiac physiological measure recorded during the stimulation ON period to the cardiac physiological measure recorded during the stimulation OFF period for the first set of stimulation intensity parameters; and

determine a first magnitude of stimulation-induced change of the cardiac physiological measure for the first set of stimulation intensity parameters based on the comparison of the cardiac physiological measure recorded during the stimulation ON period to the cardiac physiological measure recorded during the stimulation OFF period.

19. The one or more non-transitory computer-readable mediums of claim 18 , wherein the instructions are further executable by the one or more processors to:

determine a first degree of autonomic engagement for the first set of stimulation intensity parameters based on the first magnitude of stimulation-induced change;

determine that the first degree of autonomic engagement for the first set of stimulation intensity parameters is not within a neural fulcrum zone; and

responsive to the determination that the first degree of autonomic engagement is not within the neural fulcrum zone, identify a second set of stimulation intensity parameters of the neurostimulation signal based on the first degree of autonomic engagement, the second set of stimulation intensity parameters being different than the first set of stimulation intensity parameters.

20. The one or more non-transitory computer-readable mediums of claim 16 , wherein the cardiac physiological measure is at least one of an R-R interval, a P-R interval, a Q-T interval, or a heart rate variability of the patient.

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 Jan 21, 2021
From: LIBBUS, IMAD; KENKNIGHT, BRUCE; STUBBS, SCOTT; MAZAR, SCOTT
To: LIVANOVA USA, INC.
Reel/Frame 054984/0006 →