Neurostimulation in a neural fulcrum zone for the treatment of chronic cardiac dysfunction

• US 9,409,024 B2
• Filed: 03/25/2014
• Issued: 08/09/2016
• Est. Priority Date: 03/25/2014
• Status: Active Grant

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc), East Tennessee State University (University and Community College System Tennessee State)
• Original Assignee: Cyberonics, Inc
• Inventors: KenKnight, Bruce H., Ardell, Jeffrey L., Libbus, Imad, Amurthur, Badri
• Primary Examiner(s): VOORHEES, CATHERINE M
• Application Number:
  US14/224,922
• Publication Number:
  US 20150273214A1
• Time in Patent Office: 868 Days
• US Class Current: 1/1
• 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 1/3615 Intensity

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 corresponds to a combination of stimulation parameters at which autonomic engagement is achieved, while the tachycardia-inducing stimulation effects are offset by the bradycardia-inducing effects, thereby minimizing side effects such as significant heart rate changes while providing a therapeutic level of stimulation.

Claims

1. 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 to a patient, the method comprising:

activating the IMD to generate a plurality of stimulation signals, each stimulation signal of the plurality of stimulation signals having at least one parameter setting that is different as compared to a corresponding parameter setting of the other stimulation signals of the plurality of stimulation signals;

detecting a heart rate of the patient during the generation of the plurality of stimulation signals, wherein a tachycardia condition is detected with the tachycardia condition defined by a heart rate increase corresponding to a first subset of the plurality of stimulation signals and wherein a bradycardia condition is detected with the bradycardia condition defined by a heart rate reduction of greater than about 5% corresponding to a second subset of the plurality of stimulation signals; and

defining a neural fulcrum zone corresponding to a third subset of the plurality of stimulation signals during which a transition heart rate response is identifiable, the transition heart rate response being between a heart rate associated with the tachycardia condition and a heart rate associated with the bradycardia condition, the transition heart rate further comprising a heart rate reduction inclusively between about 0% and about 5%.

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

activating the IMD to chronically deliver the third subset of stimulation signals corresponding to the neural fulcrum zone.

3. A method according to claim 2, wherein the activating of the IMD to chronically deliver the third subset of stimulation signals comprises activating the IMD to treat a chronic cardiac dysfunction condition of the patient.

4. A method according to claim 1, wherein the at least one parameter setting comprises an amplitude setting.

5. A method according to claim 1, wherein the at least one parameter setting comprises a pulse width setting.

6. A method according to claim 1, wherein the at least one parameter setting comprises a duty cycle setting.

7. A method according to claim 1, wherein the at least one parameter setting comprises a frequency setting.

8. A method according to claim 1, wherein the plurality of stimulation signals includes a series of stimulation signals having a greater amplitude as compared to an immediately previous stimulation signal.

9. A method according to claim 1, wherein the plurality of stimulation signals is a first plurality of stimulation signals having a first frequency, the method further comprising:

activating the IMD to generate a second plurality of stimulation signals having a second frequency different than the first frequency, each stimulation signal of the second plurality of stimulation signals having at least one parameter setting that is different as compared to a corresponding parameter setting of the other stimulation signals of the second plurality of stimulation signals;

detecting the heart rate of the patient during the generation of the second plurality of stimulation signals, wherein at least one of another tachycardia condition is detected corresponding to a first subset of the second plurality of stimulation signals and wherein another bradycardia condition is detected corresponding to a second subset of the second plurality of stimulation signals; and

defining another neural fulcrum zone corresponding to a third subset of the second plurality of stimulation signals during which another transition heart rate response is identifiable.

10. A method according to claim 9, further comprising:

activating the IMD to chronically deliver the third subset of stimulation signals corresponding to the another neural fulcrum zone.

11. A method according to claim 10, wherein the activating of the IMD to chronically deliver the third subset of stimulation signals comprises activating the IMD to treat a chronic cardiac dysfunction condition of the patient.

12. A method according to claim 1, further comprising:

prior to activating the IMD to generate the plurality of stimulation signals, completing a titration process in which a stimulation intensity is gradually increased over a period of time.

13. A method according to claim 1, wherein the IMD is adapted to deliver the stimulation signal to a vagus nerve of the patient.

14. A method of identifying a set of parameter settings for an implantable medical device (IMD) for treating a chronic cardiac dysfunction condition of a patient, the method comprising:

activating the IMD to generate a plurality of stimulation signals at a same frequency, each stimulation signal of the plurality of stimulation signals having at least one parameter setting that is different as compared to a corresponding parameter setting of the other stimulation signals of the plurality of stimulation signals;

detecting a heart rate of the patient during the generation of the plurality of stimulation signals, wherein a tachycardia condition is detected with the tachycardia condition defined by a heart rate increase corresponding to a first subset of the plurality of stimulation signals and wherein a bradycardia condition is detected with the bradycardia condition defined by a heart rate reduction of greater than about 5% corresponding to a second subset of the plurality of stimulation signals; and

defining a neural fulcrum zone corresponding to a third subset of the plurality of stimulation signals during which a transition heart rate response is identifiable, the transition heart rate response comprising a heart rate reduction inclusively between about 0% and about 5%.

15. A neurostimulation system, comprising:

an implantable medical device (IMD) comprising a neurostimulator coupled to an electrode assembly, the neurostimulator adapted to deliver a plurality of stimulation signals to a patient; and

a control system programmed to;

detect a heart rate of when the IMD generates the plurality of stimulation signals, each stimulation signal of the plurality of stimulation signals having at least one parameter setting that is different as compared to a corresponding parameter setting of the other stimulation signals of the plurality of stimulation signals;

define a first subset of the plurality of stimulation signals during which a tachycardia condition of the patient is detected, the tachycardia condition defined by a heart rate increase;

define a second subset of the plurality of stimulation signals during which a bradycardia condition of the patient is detected, the bradycardia condition defined by a heart rate decrease of greater than about 5%; and

define a neural fulcrum zone corresponding to a third subset of the plurality of stimulation signals during which a transition heart rate response is identifiable, the transition heart rate response being between a heart rate associated with the tachycardia condition and a heart rate associated with the bradycardia condition, the transition heart rate response further comprising a heart rate decrease inclusively between about 0% and about 5%.

16. A system according to claim 15, wherein the control system is further programmed to:

activate the IMD to chronically deliver the third subset of stimulation signals corresponding to the neural fulcrum zone.

17. A system according to claim 16, wherein the control system is programmed to activate the IMD to chronically deliver the third subset of stimulation signals to treat a chronic cardiac dysfunction condition of the patient.

18. A system according to claim 15, wherein the at least one parameter setting comprises an amplitude setting.

19. A system according to claim 15, wherein the at least one parameter setting comprises a pulse width setting.

20. A system according to claim 15, wherein the at least one parameter setting comprises a duty cycle setting.

21. A system according to claim 15, wherein the at least one parameter setting comprises a frequency setting.

22. A system according to claim 15, wherein the plurality of stimulation signals includes a series of stimulation signals having a greater amplitude as compared to an immediately previous stimulation signal.

23. A system according to claim 15, wherein the plurality of stimulation signals is a first plurality of stimulation signals having a first frequency and wherein the control system is further programmed to:

activate the IMD to generate a second plurality of stimulation signals having a second frequency different than the first frequency, each stimulation signal of the second plurality of stimulation signals having at least one parameter setting that is different as compared to a corresponding parameter setting of the other stimulation signals of the second plurality of stimulation signals;

detecting the heart rate of the patient during the generation of the second plurality of stimulation signals, wherein at least one of another tachycardia condition is detected corresponding to a first subset of the second plurality of stimulation signals and wherein another bradycardia condition is detected corresponding to a second subset of the second plurality of stimulation signals; and

defining another neural fulcrum zone corresponding to a third subset of the second plurality of stimulation signals during which another transition heart rate response is identifiable.

24. A system according to claim 23, wherein the control system is further programmed to:

activate the IMD to chronically deliver the third set of stimulation signals corresponding to the another neural fulcrum zone.

25. A system according to claim 24, wherein the control system is configured to activate the IMD to chronically deliver the third subset of stimulation signals to treat a chronic cardiac dysfunction condition of the patient.

26. A system according to claim 15, wherein the control system is further programmed to:

prior to activating the IMD to generate the plurality of stimulation signals, complete a titration process in which an stimulation intensity is gradually increased over a period of time.

27. A system according to claim 15, wherein the IMD is adapted to deliver the stimulation signal to a vagus nerve of the patient.