Responsive neurostimulation for the treatment of chronic cardiac dysfunction

• US 10,166,391 B2
• Filed: 11/06/2017
• Issued: 01/01/2019
• Est. Priority Date: 05/07/2014
• Status: Active Grant

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc), East Tennessee State University (University and Community College System Tennessee State)
• Original Assignee: Cybertronics Incorporated, East Tennessee State University (University and Community College System Tennessee State)
• Inventors: Libbus, Imad, Amurthur, Badri, KenKnight, Bruce H., Ardell, Jeffrey L.
• Primary Examiner(s): Mahmood, Nadia A
• Application Number:
  US15/805,062
• Publication Number:
  US 20180117333A1
• Time in Patent Office: 421 Days
• Field of Search: 607 62, 607 4
• 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 1/36135 using physiological parameters
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/3615 Intensity
• CPC Class Codes: A61N 1/37217 characterised by the communication link, e.g. acoustic or tactile
• CPC Class Codes: A61N 1/37264 Changing the program; Upgrading firmware

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. The implanted stimulation device includes a physiological sensor for monitoring the patient'"'"'s response to the neurostimulation therapy on an ambulatory basis over extended periods of time and a control system for adjusting stimulation parameters to maintain stimulation in the neural fulcrum zone based on detected changes in the physiological response to stimulation.

Claims

1. A neurostimulation system, comprising:

an electrode assembly; and

a neurostimulator coupled to the electrode assembly, the neurostimulator comprising;

a control circuit; and

a memory operably coupled to the control circuit and comprising instructions that, when executed by the control circuit, cause the control circuit to;

deliver stimulation signals to a patient via the electrode assembly;

increase an intensity of the stimulation signals until a tachycardia heart rate response in the patient is detected;

continue to increase the intensity of the stimulation signals until a bradycardia heart rate response in the patient is detected; and

deliver therapeutic stimulation signals to the patient at an intensity producing a transition heart rate response in the patient, wherein the transition heart rate response corresponds to a zone between the tachycardia heart rate response and the bradycardia heart rate response and is a heart rate reduction between a baseline heart rate and a predefined threshold.

2. The neurostimulation system of claim 1, wherein the stimulation signals comprise an output current amplitude, a pulse width, a pulse frequency, and a duty cycle.

3. The neurostimulation system of claim 2, wherein the instructions cause the control circuit to increase the intensity of the stimulation signals by increasing at least one of the output current amplitude, the pulse width, the pulse frequency, or the duty cycle of the stimulation signals.

4. The neurostimulation system of claim 1, wherein the transition heart rate response is a 0% to 5% reduction from the baseline heart rate.

5. The neurostimulation system of claim 1, wherein the stimulation signals are delivered to a vagus nerve of the patient.

6. The neurostimulation system of claim 1, wherein the instructions further cause the control circuit to:

deliver the stimulation signals to the patient via the electrode assembly at a first frequency and at a second frequency;

for each of the first frequency and the second frequency, increase the intensity of the stimulation signals until a tachycardia heart rate response in the patient is detected;

for each of the first frequency and the second frequency, continue to increase the intensity of the stimulation signals until a bradycardia heart rate response in the patient is detected; and

deliver the therapeutic stimulation signals to the patient at one of the first frequency or the second frequency and at an intensity producing a transition heart rate response in the patient at the one of the first frequency or the second frequency.

7. The neurostimulation system of claim 6, wherein the instructions cause the control circuit to increase the intensity of the stimulation signals by increasing an output current amplitude of the stimulation signals.

8. A method of operating a neurostimulator coupled to an electrode assembly, comprising:

delivering stimulation signals to a patient via the electrode assembly;

increasing an intensity of the stimulation signals until a tachycardia heart rate response in the patient is detected;

continuing to increase the intensity of the stimulation signals until a bradycardia heart rate response in the patient is detected; and

delivering therapeutic stimulation signals to the patient at an intensity producing a transition heart rate response in the patient, wherein the transition heart rate response corresponds to a zone between the tachycardia heart rate response and the bradycardia heart rate response and is a heart rate reduction between a baseline heart rate and a predefined threshold.

9. The method of claim 8, wherein the stimulation signals comprise an output current amplitude, a pulse width, a pulse frequency, and a duty cycle.

10. The method of claim 9, wherein increasing the intensity of the stimulation signals comprises increasing at least one of the output current amplitude, the pulse width, the pulse frequency, or the duty cycle of the stimulation signals.

11. The method of claim 8, wherein the transition heart rate response is a 0% to 5% reduction from the baseline heart rate.

12. The method of claim 8, wherein the stimulation signals are delivered to a vagus nerve of the patient.

13. The method of claim 8, wherein:

delivering the stimulation signals comprises delivering stimulation signals to a patient via the electrode assembly at a first frequency and a second frequency;

increasing the intensity of the stimulation signals until a tachycardia heart rate response in the patient is detected comprises, for each of the first frequency and the second frequency, increasing the intensity of the stimulation signals until a tachycardia heart rate response in the patient is detected;

continuing to increase the intensity of the stimulation signals until a bradycardia heart rate response in the patient is detected comprises, for each of the first frequency and the second frequency, continuing to increase the intensity of the stimulation signals until a bradycardia heart rate response in the patient is detected; and

delivering the therapeutic stimulation signals to the patient comprises delivering therapeutic stimulation signals to the patient at one of the first frequency or the second frequency and at an intensity producing a transition heart rate response in the patient at the one of the first frequency or the second frequency.

14. The method of claim 13, wherein increasing the intensity of the stimulation signals comprises increasing an output current amplitude of the stimulation signals.

15. A memory coupled to a processor and comprising instructions that, when executed by the processor, cause the processor to:

deliver stimulation signals to a patient via an electrode assembly;

increase an intensity of the stimulation signals until a tachycardia heart rate response in the patient is detected;

continue to increase the intensity of the stimulation signals until a bradycardia heart rate response in the patient is detected; and

deliver therapeutic stimulation signals to the patient at an intensity producing a transition heart rate response in the patient, wherein the transition heart rate response corresponds to a zone between the tachycardia heart rate response and the bradycardia heart rate response and is a heart rate reduction between a baseline heart rate and a predefined threshold.

16. The memory of claim 15, wherein the stimulation signals comprise an output current amplitude, a pulse width, a pulse frequency, and a duty cycle.

17. The memory of claim 16, wherein the instructions cause the processor to increase the intensity of the stimulation signals by increasing at least one of the output current amplitude, the pulse width, the pulse frequency, or the duty cycle of the stimulation signals.

18. The memory of claim 15, wherein the transition heart rate response a 0% to 5% reduction from the baseline heart rate.

19. The memory of claim 15, wherein the instructions further cause the processor to:

deliver the stimulation signals to the patient via the electrode assembly at a first frequency and at a second frequency;

for each of the first frequency and the second frequency, increase the intensity of the stimulation signals until a tachycardia heart rate response in the patient is detected;

for each of the first frequency and the second frequency, continue to increase the intensity of the stimulation signals until a bradycardia heart rate response in the patient is detected; and

deliver the therapeutic stimulation signals to the patient at one of the first frequency or the second frequency and at an intensity producing a transition heart rate response in the patient at the one of the first frequency or the second frequency.

20. The memory of claim 19, wherein the instructions cause the processor to increase the intensity of the stimulation signals by increasing an output current amplitude of the stimulation signals.