Responsive neurostimulation for the treatment of chronic cardiac dysfunction

• US 9,808,626 B2
• Filed: 09/16/2016
• Issued: 11/07/2017
• 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: Cyberonics, Inc, 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 AHMAD
• Application Number:
  US15/267,922
• Publication Number:
  US 20170001012A1
• Time in Patent Office: 417 Days
• Field of Search: 607 2, 607 6, 607 9, 607 62
• 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 pulses via the electrode assembly using a first set of stimulation parameters to cause a heart rate response in a neural fulcrum zone, the neural fulcrum zone being defined by a heart rate reduction between a baseline heart rate and a predefined threshold;

detect whether the heart rate response caused by the first set of stimulation parameters has deviated from the neural fulcrum zone by comparing the heart rate response to the baseline heart rate and the predefined threshold detecting whether the heart rate response has deviated from the neural fulcrum zone comprising detecting that the heart rate response has deviated from the neural fulcrum zone in response to detecting either a heart rate reduction of greater than the predefined threshold or a heart rate at or above the baseline heart rate;

continue to deliver the stimulation pulses using the first set of stimulation parameters in response to detecting the heart rate response remains within the neural fulcrum zone; and

deliver the stimulation pulses using a second set of stimulation parameters in response to determining the heart rate response has deviated from the neural fulcrum zone, the stimulation pulses using second set of parameters configured to modify the heart rate response back to the neural fulcrum zone.

2. The neurostimulation system according to claim 1, wherein in response to detecting tachycardia, the control circuit sets the second set of stimulation parameters to include a first stimulation intensity greater than a second stimulation intensity of the first set of stimulation parameters, and in response to detecting bradycardia, the control circuit sets the second set of stimulation parameters to include a third stimulation intensity less than the second stimulation intensity of the first set of stimulation parameters.

3. The neurostimulation system according to claim 1, wherein the control circuit continuously detects whether the heart rate response caused by the first set of stimulation parameters has deviated from the neural fulcrum zone.

4. The neurostimulation system according to claim 1, wherein the control circuit periodically detects whether the heart rate response caused by the first set of stimulation parameters has deviated from the neural fulcrum zone.

5. The neurostimulation system according to claim 1, wherein the control circuit detects whether the heart rate response caused by the first set of stimulation parameters has deviated from the neural fulcrum zone in response to a control input.

6. The neurostimulation system according to claim 5, wherein said control input comprises an input from at least one of a programmer or a magnet.

7. The neurostimulation system according to claim 5, wherein the control circuit sets the second set of stimulation parameters to include a first stimulation intensity less than a second stimulation intensity of the first set of stimulation parameters in response to receiving the control input.

8. The neurostimulation system according to claim 1, wherein the second set of stimulation parameters have a first stimulation intensity and the first set of stimulation parameters have a second stimulation intensity, wherein the stimulation intensity is defined by at least one of a pulse width, a pulse frequency, an output current or a duty cycle.

9. A 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 pulses using a first set of stimulation parameters to cause a heart rate response in a neural fulcrum zone, the neural fulcrum zone being defined by a heart rate reduction between a baseline heart rate and a predefined threshold;

detect whether the heart rate response caused by the first set of stimulation parameters has deviated from the neural fulcrum zone by comparing the heart rate response to the baseline heart rate and the predefined threshold, detecting whether the heart rate response has deviated from the neural fulcrum zone comprising detecting that the heart rate response has deviated from the neural fulcrum zone in response to detecting either a heart rate reduction of greater than the predefined threshold or a heart rate at or above the baseline heart rate;

continue to deliver the stimulation pulses using the first set of stimulation parameters in response to detecting the heart rate response remains within the neural fulcrum zone; and

deliver the stimulation pulses using a second set of stimulation parameters in response to determining the heart rate response has deviated from the neural fulcrum zone, the stimulation pulses using second set of parameters configured to modify the heart rate response back to the neural fulcrum zone.

10. The neurostimulator according to claim 9, wherein in response to detecting tachycardia, the control circuit sets the second set of stimulation parameters to include a first stimulation intensity greater than a second stimulation intensity of the first set of stimulation parameters, and in response to detecting bradycardia, the control circuit sets the second set of stimulation parameters to include a third stimulation intensity less than the second stimulation intensity of the first set of stimulation parameters.

11. The neurostimulator according to claim 9, wherein the control circuit continuously detects whether the heart rate response caused by the first set of stimulation parameters has deviated from the neural fulcrum zone.

12. The neurostimulator according to claim 9, wherein the control circuit periodically detects whether the heart rate response caused by the first set of stimulation parameters has deviated from the neural fulcrum zone.

13. The neurostimulator according to claim 9, wherein the control circuit detects whether the heart rate response caused by the first set of stimulation parameters has deviated from the neural fulcrum zone in response to a control input.

14. The neurostimulator according to claim 13, wherein said control input comprises an input from at least one of a programmer or a magnet.

15. The neurostimulator according to claim 13, wherein the control circuit sets the second set of stimulation parameters to include a first stimulation intensity less than a second stimulation intensity of the first set of stimulation parameters in response to receiving the control input.

16. A method of delivering neurostimulation, the method comprising:

delivering stimulation pulses using a first set of stimulation parameters to cause a heart rate response in a neural fulcrum zone, the neural fulcrum zone being defined by a heart rate reduction between a baseline heart rate and a predefined threshold;

detecting whether the heart rate response caused by the first set of stimulation parameters has deviated from the neural fulcrum zone by comparing the heart rate response to the baseline heart rate and the predefined threshold, detecting whether the heart rate response has deviated from the neural fulcrum zone comprising detecting that the heart rate response has deviated from the neural fulcrum zone in response to detecting either a heart rate reduction of greater than the predefined threshold or a heart rate at or above the baseline heart rate;

continuing to deliver the stimulation pulses using the first set of stimulation parameters in response to detecting the heart rate response remains within the neural fulcrum zone; and

delivering the stimulation pulses using a second set of stimulation parameters in response to determining the heart rate response has deviated from the neural fulcrum zone, the stimulation pulses using second set of parameters configured to modify the heart rate response back to the neural fulcrum zone.

17. The method according to claim 16, wherein delivering the stimulation pulses using the second set of stimulation parameters comprises, in response to detecting tachycardia, setting the second set of stimulation parameters to include a first stimulation intensity greater than a second stimulation intensity of the first set of stimulation parameters and, in response to detecting bradycardia, setting the second set of stimulation parameters to include a third stimulation intensity less than the second stimulation intensity of the first set of stimulation parameters.

18. The method according to claim 16, wherein detecting whether the heart rate response caused by the first set of stimulation parameters has deviated from the neural fulcrum zone occurs in response to a control input.

19. The method according to claim 18, wherein the control input comprises an input from at least one of a programmer or a magnet.

20. The method according to claim 18, wherein delivering the stimulation pulses using the second set of stimulation parameters comprises setting the second set of stimulation parameters to include a first stimulation intensity less than a second stimulation intensity of the first set of stimulation parameters in response to receiving the control input.