Fine resolution identification of a neural fulcrum for the treatment of chronic cardiac dysfunction

• US 10,463,859 B2
• Filed: 05/03/2017
• Issued: 11/05/2019
• Est. Priority Date: 04/17/2014
• 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: KenKnight, Bruce H., Libbus, Imad, Amurthur, Badri, Ardell, Jeffrey L.
• Primary Examiner(s): Abreu, Michael J D
• Application Number:
  US15/585,742
• Publication Number:
  US 20170296824A1
• Time in Patent Office: 916 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 1/36157 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 neural fulcrum zone is identified and ongoing neurostimulation therapy is delivered within the neural fulcrum zone. This neural fulcrum zone may be identified by monitoring a patient'"'"'s response to incrementally increased intensity settings at a first frequency. If the incremental intensity increases do not result in the identification of the neural fulcrum zone, the frequency may be changed to provide finer resolution identification of the neural fulcrum zone.

Claims

1. An implantable medical device (IMD) comprising:

a neurostimulator coupled to an electrode assembly, said neurostimulator configured to deliver a stimulation signal to a patient; and

a control system configured to;

monitor a heart rate of a patient implanted with the IMD;

deliver to the patient a first set of stimulation signals at a first frequency, wherein said delivering comprises increasing the intensity parameter level for subsequent stimulation signals until bradycardia is detected;

detect whether a response to the stimulation signal having a first intensity parameter level below a second intensity parameter level at which bradycardia is detected is tachycardia or a transition heart rate response;

responsive to detecting that the response to the stimulation signal having the first intensity parameter level is tachycardia, deliver to the patient a second set of stimulation signals at a second frequency different than the first frequency, wherein said delivering the second set of stimulation signals comprises increasing the intensity parameter level for subsequent stimulation signals until bradycardia is detected; and

responsive to detecting that the response to the stimulation signal having the first intensity parameter level is the transition heart rate response, continue to deliver to the patient the stimulation signal having the first intensity parameter level.

2. The IMD according to claim 1, wherein the control system is further configured to chronically deliver the stimulation signal having the first intensity parameter level.

3. The IMD according to claim 2, wherein said chronically delivering stimulation signals comprises activating the IMD to chronically deliver the stimulation signal having the first intensity parameter level to treat chronic cardiac dysfunction.

4. The IMD according to claim 1, wherein the transition heart rate response comprises a heart rate change of between 0% and 5% reduced heart rate.

5. The IMD according to claim 1, wherein:

said intensity parameter level comprises at least one of a pulse width, a duty cycle or an output current; and

said delivering the first set of stimulation signals comprises increasing at least one of the pulse width, the duty cycle or the output current for subsequent stimulation signals until bradycardia is detected.

6. The IMD according to claim 1, wherein at least one of the first frequency or second frequency comprises at least one of approximately 10 Hz or approximately 5 Hz.

7. The IMD according to claim 1, wherein the control system is further configured to, prior to delivering the first set of stimulation signals, complete a titration process in which stimulation intensity is gradually increased over a period of time to adapt the patient to the stimulation.

8. The IMD according to claim 1, wherein the control system is configured to deliver the stimulation signals to a vagus nerve of the patient.

9. The IMD according to claim 1, wherein the neurostimulator is further configured to, in the second set of stimulation signals if tachycardia is detected in response to the stimulation signal having the first intensity parameter level, deliver to the patient a third set of stimulation signals at a third frequency different than the first frequency and the second frequency, wherein said delivering the third set of stimulation signals comprises increasing the intensity parameter level for subsequent stimulation signals until bradycardia is detected.

10. The system according to claim 1, wherein the control system is further configured to, based on detecting the transition heart rate response in response to the stimulation signal having the first intensity parameter level, identify the stimulation signal resulting in the transition heart rate response as corresponding to a neural fulcrum zone.

11. A method of operating an implantable medical device (IMD) comprising a neurostimulator coupled to an electrode assembly, said neurostimulator adapted to deliver a stimulation signal at a plurality of intensity parameter levels, said method comprising:

monitoring a heart rate of a patient implanted with the IMD;

delivering to the patient a first set of stimulation signals at a first frequency, wherein said delivering comprises increasing the intensity parameter level for subsequent stimulation signals until bradycardia is detected;

detecting whether a response to the stimulation signal having a first intensity parameter level below a second intensity parameter level at which bradycardia is detected is tachycardia or a transition heart rate response;

responsive to detecting that the response to the stimulation signal having the first intensity parameter level is tachycardia, delivering to the patient a second set of stimulation signals at a second frequency different than the first frequency, wherein said delivering the second set of stimulation signals comprises increasing the intensity parameter level for subsequent stimulation signals until bradycardia is detected; and

responsive to detecting that the response to the stimulation signal having the first intensity parameter level is the transition heart rate response, continue to deliver to the patient the stimulation signal having the first intensity parameter level.

12. The method according to claim 11, further comprising activating the IMD to chronically deliver the stimulation signal having the first intensity parameter level.

13. The method according to claim 12, wherein said activating the IMD to chronically deliver stimulation signals comprises activating the IMD to chronically deliver the stimulation signal having the first intensity parameter level to treat chronic cardiac dysfunction.

14. The method according to claim 11, wherein the transition heart rate response comprises a heart rate change of between 0% and 5% reduced heart rate.

15. The method according to claim 11, wherein:

said intensity parameter level comprises at least one of a pulse width, a duty cycle or an output current; and

said delivering the first set of stimulation signals comprises increasing at least one of the pulse width, the duty cycle or the output current for subsequent stimulation signals until bradycardia is detected.

16. The method according to claim 11, wherein at least one of the first frequency or second frequency comprises at least one of approximately 10 Hz or approximately 5 Hz.

17. The method according to claim 11, further comprising, prior to delivering the first set of stimulation signals, completing a titration process in which stimulation intensity is gradually increased over a period of time to adapt the patient to the stimulation.

18. The method according to claim 11, further comprising delivering the stimulation signals to a vagus nerve of the patient.

19. The method according to claim 11, further comprising, in the second set of stimulation signals if tachycardia is detected in response to the stimulation signal having the first intensity parameter level, delivering to the patient a third set of stimulation signals at a third frequency different than the first frequency and the second frequency, wherein said delivering the third set of stimulation signals comprises increasing the intensity parameter level for subsequent stimulation signals until bradycardia is detected.

20. The method according to claim 11, further comprising, based on detecting the transition heart rate response in response to the stimulation signal having the first intensity parameter level, identifying the stimulation signal resulting in the transition heart rate response as corresponding to a neural fulcrum zone.

21. A neurostimulation system, comprising:

an electrode assembly configured to deliver a stimulation signal to a patient; and

an implantable medical device (IMD) comprising;

a neurostimulator coupled to the electrode assembly, said neurostimulator configured to deliver the stimulation signal to the electrode assembly; and

a control system configured to;

monitor the heart rate of the patient implanted with the IMD;

deliver to the electrode assembly a first set of stimulation signals at a first frequency, wherein said delivering comprises increasing the intensity parameter level for subsequent stimulation signals until bradycardia is detected;

detect whether a response to the stimulation signal having a first intensity parameter level below a second intensity parameter level at which bradycardia is detected is tachycardia or a transition heart rate response;

responsive to detecting that the response to the stimulation signal having the first intensity parameter level is tachycardia, deliver to the electrode assembly a second set of stimulation signals at a second frequency different than the first frequency, wherein said delivering the second set of stimulation signals comprises increasing the intensity parameter level for subsequent stimulation signals until bradycardia is detected; and

responsive to detecting that the response to the stimulation signal having the first intensity parameter level is the transition heart rate response, continue to deliver to the patient the stimulation signal having the first intensity parameter level.

22. The system according to claim 21, wherein at least one of the first frequency or second frequency comprises at least one of approximately 10 Hz or approximately 5 Hz.

23. The system according to claim 21, wherein the control system is further configured to, based on detecting the transition heart rate response in response to the stimulation signal having the first intensity parameter level, identify the stimulation signal resulting in the transition heart rate response as corresponding to a neural fulcrum zone.