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

• US 9,713,719 B2
• Filed: 04/17/2014
• Issued: 07/25/2017
• 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: Cyberonics, Inc, East Tennessee State University (University and Community College System Tennessee State)
• Inventors: KenKnight, Bruce H., Libbus, Imad, Amurthur, Badri, Ardell, Jeffrey L.
• Primary Examiner(s): D ABREU, MICHAEL JOSEPH
• Application Number:
  US14/255,276
• Publication Number:
  US 20150297894A1
• Time in Patent Office: 1,195 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. 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 at predefined increments, 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 incrementally increasing the intensity parameter level by the predefined increment for subsequent stimulation signals until bradycardia is detected;

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

based on detecting tachycardia in response to the stimulation signal having the first intensity parameter level, delivering to the patient a second set of stimulation signals at a second frequency lower than the first frequency, wherein said delivering the second set of stimulation signals comprises incrementally increasing the intensity parameter level by the predefined increment for subsequent stimulation signals until bradycardia is detected; and

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.

2. The method according to claim 1, further comprising:

activating the IMD to chronically deliver stimulation signals corresponding to the identified neural fulcrum zone.

3. The method according to claim 2, wherein said activating the IMD to chronically deliver stimulation signals comprises activating the IMD to chronically deliver stimulation signals corresponding the identified neural fulcrum zone to treat chronic cardiac dysfunction.

4. The method according to claim 1, wherein:

said intensity parameter level comprises an output current; and

said delivering the first set of stimulation signals comprises incrementally increasing the output current by the predefined increment for subsequent stimulation signals until bradycardia is detected.

5. The method according to claim 4, wherein:

said predefined increment comprises approximately 0.25 mA; and

said incrementally increasing the output current by the predefined increment comprises incrementally increasing the output current by 0.5 mA for subsequent stimulation signals until bradycardia is detected.

6. The method according to claim 1, wherein:

said first frequency comprises approximately 10 Hz.

7. The method according to claim 6, wherein:

said second frequency comprises approximately 5 Hz.

8. The method according to claim 1, wherein:

the transition heart rate response comprises a heart rate change of between 0% and 5% reduced heart rate.

9. The method according to claim 1, wherein:

said intensity parameter level comprises a pulse width or duty cycle.

10. The method according to claim 1, 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.

11. The method according to claim 1, wherein said IMD is adapted to deliver the stimulation signals to a vagus nerve of the patient.

12. The method according to claim 1, wherein:

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 lower than the second frequency, wherein said delivering the third set of stimulation signals comprises incrementally increasing the intensity parameter level by the predefined increment for subsequent stimulation signals until bradycardia is detected.

13. 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 at predefined increments, 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 incrementally increasing the intensity parameter level by the predefined increment for subsequent stimulation signals until either bradycardia or a transition heart rate response is detected;

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

based on detecting tachycardia in response to the stimulation signal having the first intensity parameter level, delivering to the patient a second set of stimulation signals at a second frequency lower than the first frequency, wherein said delivering the second set of stimulation signals comprises incrementally increasing the intensity parameter level by the predefined increment until either bradycardia or a transition heart rate response is detected; and

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.

14. The method according to claim 13, further comprising:

activating the IMD to chronically deliver stimulation signals corresponding to the identified neural fulcrum zone.

15. The method according to claim 14, wherein said activating the IMD to chronically deliver stimulation signals comprises activating the IMD to chronically deliver stimulation signals corresponding the identified neural fulcrum zone to treat chronic cardiac dysfunction.

16. The method according to claim 13, wherein:

said intensity parameter level comprises an output current; and

said delivering the first set of stimulation signals comprises incrementally increasing the output current by the predefined increment for subsequent stimulation signals until bradycardia is detected.

17. The method according to claim 16, wherein:

said predefined increment comprises approximately 0.5 mA; and

said incrementally increasing the output current by the predefined increment comprises incrementally increasing the output current by 0.5 mA for subsequent stimulation signals until bradycardia is detected.

18. The method according to claim 13, wherein:

said first frequency comprises approximately 10 Hz.

19. The method according to claim 18, wherein:

said second frequency comprises approximately 5 Hz.

20. The method according to claim 13, wherein:

the transition heart rate response comprises a heart rate change of between 0% and 5% reduced heart rate.

21. The method according to claim 13, wherein:

said intensity parameter level comprises a pulse width or duty cycle.

22. The method according to claim 13, 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.

23. The method according to claim 13, wherein said IMD is adapted to deliver the stimulation signals to a vagus nerve of the patient.

24. A neurostimulation system, comprising:

an implantable medical device (IMD) comprising a neurostimulator coupled to an electrode assembly, said neurostimulator adapted to deliver a stimulation signal to a patient; and

a control system programmed to;

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

activate the IMD to deliver to the patient a first set of stimulation signals at a first frequency, wherein said delivery comprises incrementally increasing the intensity parameter level by the predefined increment for subsequent stimulation signals until bradycardia is detected;

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

activate the IMD, based on detection of tachycardia in response to the stimulation signal having the first intensity parameter level, to deliver to the patient a second set of stimulation signals at a second frequency lower than the first frequency, wherein said delivery of the second set of stimulation signals comprises incrementally increasing the intensity parameter level by the predefined increment for subsequent stimulation signals until bradycardia is detected; and

identify, based on the detection of the transition heart rate response in response to the stimulation signal having the first intensity parameter, the stimulation signal resulting in the transition heart rate response as corresponding to a neural fulcrum zone.

25. The system according to claim 24, wherein the control system is further programmed to activate the IMD to chronically deliver stimulation signals corresponding to the identified neural fulcrum zone.

26. The system according to claim 25, wherein the control system is programmed to activate the IMD to chronically deliver stimulation signals corresponding to the identified neural fulcrum zone to treat chronic cardiac dysfunction.

27. The system according to claim 24, wherein said intensity parameter level comprises an output current.

28. The system according to claim 27, wherein said predefined increment comprises approximately 0.5 mA.

29. The system according to claim 24, wherein:

the transition heart rate response comprises a heart rate change of between 0% and 5% reduced heart rate.

30. A system according to claim 24, wherein:

said IMD is adapted to deliver the stimulation signal to a vagus nerve of the patient.