Dynamic stimulation adjustment for identification of a neural fulcrum

• US 10,426,961 B2
• Filed: 04/20/2018
• Issued: 10/01/2019
• Est. Priority Date: 04/25/2014
• Status: Active Grant

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc), East Tennessee State University (University and Community College System Tennessee State)
• Original Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Inventors: Libbus, Imad, Amurthur, Badri, KenKnight, Bruce H., Ardell, Jeffrey L.
• Primary Examiner(s): Hulbert, Amanda K
• Application Number:
  US15/958,985
• Publication Number:
  US 20180243566A1
• Time in Patent Office: 529 Days
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/36146 specified by the stimulation parameters
• CPC Class Codes: A61N 1/36157 Current A61N1/3616 takes precedence
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy

Abstract

Systems and methods are provided for delivering neurostimulation therapies to patients for treating chronic heart failure. A computer-implemented control system is operated to automatically identify a neural fulcrum zone based on a monitored patient physiological response. Ongoing neurostimulation therapy is delivered within the neural fulcrum zone.

Claims

1. A neurostimulation system, comprising:

an implantable medical device (IMD) comprising a neurostimulator coupled to an electrode assembly, the neurostimulator adapted to deliver stimulation signals to a patient, each stimulation signal comprising an ON time and an OFF time; and

a control system programmed to;

monitor a heart rate of a patient implanted with the IMD during delivery to the patient of a plurality of stimulation signals at a first frequency, each stimulation signal having at least one parameter setting different than parameter settings of the other stimulation signals in the plurality of stimulation signals, wherein monitoring the heart rate comprises monitoring a baseline heart rate during the OFF time periods of each stimulation signal and monitoring a heart rate response during the ON time periods of each stimulation signal, the heart rate response comprising a percentage change from the baseline heart rate;

compare the percentage change of the heart rate response for each of the plurality of stimulation signals to a first threshold and a second threshold less than the first threshold; and

deliver stimulation comprising one or more stimulation signals from the plurality of stimulation signals causing a percentage change of the heart rate response between the first and second thresholds.

2. The system of claim 1, wherein the IMD further comprises a heart rate sensor, and wherein the control system is provided in the IMD.

3. The system of claim 1, wherein the control system is in wireless communication with the IMD.

4. The system of claim 1, wherein the control system is programmed to monitor the baseline heart rate during the OFF time periods of the stimulation signal after a delay period following the ON time periods of the stimulation signal.

5. The system of claim 1, wherein the control system is further programmed to:

calculate a baseline heart rate average of a plurality of OFF time periods of the stimulation signal; and

calculate a heart rate response average of a plurality of ON time periods of the stimulation signal.

6. The system of claim 1, wherein the control system is further programmed to detect a first subset of signals causing percentage changes greater than the first threshold as corresponding to tachycardia.

7. The system of claim 1, wherein the control system is further programmed to detect a second subset of signals causing percentage changes less than the second threshold as corresponding to bradycardia.

8. The system of claim 1, wherein the control system is further programmed to detect a third subset of signals causing percentage changes between the first and second thresholds as corresponding to a neural fulcrum zone, the third subset of signals comprising the one or more stimulation signals.

9. The system of claim 1, wherein the at least one parameter setting different than the parameter settings of the other stimulation signals in the plurality of stimulation signals comprises an amplitude.

10. The system of claim 1, wherein the at least one parameter setting different than the parameter settings of the other stimulation signals in the plurality of stimulation signals comprises a pulse width.

11. The system of claim 1, wherein the at least one parameter setting different than the parameter settings of the other stimulation signals in the plurality of stimulation signals comprises a duty cycle.

12. The system of claim 1, wherein the control system is further programmed to first subset of signals activate the IMD to deliver to the patient the plurality of stimulation signals, each stimulation signal comprising an amplitude greater than an amplitude of the immediately previous stimulation signal.

13. The system of claim 1, wherein the control system is further programmed to, prior to activating the IMD to deliver to the patient the plurality of stimulation signals at the first frequency, complete a titration process in which stimulation intensity is gradually increased over a period of time as the patient adapts to the stimulation.

14. A method of operating an implantable medical device (IMD) comprising a neurostimulator coupled to an electrode assembly, the neurostimulator adapted to deliver a stimulation signal comprising an ON time and an OFF time, the method comprising:

operating a control system to activate the IMD to deliver to a patient a plurality of stimulation signals at a first frequency, each stimulation signal having at least one parameter setting different than parameter settings of the other stimulation signals in the plurality of stimulation signals;

monitoring a baseline heart rate during the OFF time periods of each stimulation signal;

monitoring a heart rate response during the ON time periods of each stimulation signal, the heart rate response comprising a percentage change from the baseline heart rate;

comparing the percentage changes of the heart rate responses for the plurality of stimulation signals to a first threshold and a second threshold less than the first threshold; and

delivering stimulation comprising one or more stimulation signals from the plurality of stimulations signals causing a percentage change of the heart rate response between the first and second thresholds.

15. The method of claim 14, wherein operating the control system comprises operating an implanted control system.

16. The method of claim 14, wherein operating the control system comprises operating an external control system in wireless communication with the IMD.

17. The method of claim 14, further comprising detecting a first subset of signals causing percentage changes greater than the first threshold as corresponding to tachycardia.

18. The method of claim 14, further comprising detecting a second subset of signals causing percentage changes less than the second threshold as corresponding to bradycardia.

19. The method of claim 14, further comprising detecting a third subset of signals causing percentage changes between the first threshold and the second threshold as corresponding to a neural fulcrum zone, the third subset of signals comprising the one or more stimulation signals.

20. A non-transitory computer-readable medium comprising instructions executable by a processor to:

activate a neurostimulator of an implantable medical device (IMD) to deliver to a patient a plurality of stimulation signals at a first frequency, each stimulation signal having at least one parameter setting different than parameter settings of the other stimulation signals in the plurality of stimulation signals and each stimulation signal comprising an ON time and an OFF time;

monitor a heart rate of the patient during delivery of the plurality of stimulation signals, wherein monitoring the heart rate comprises monitoring a baseline heart rate during the OFF time periods of each stimulation signal and monitoring a heart rate response during the ON time periods of each stimulation signal, the heart rate response comprising a percentage change from the baseline heart rate;

compare the percentage change of the heart rate response for each of the plurality of stimulation signals to a first threshold and a second threshold less than the first threshold; and

deliver stimulation comprising one or more stimulation signals from the plurality of stimulation signals causing a percentage change of the heart rate response between the first and second thresholds.