Responsive neurostimulation for the treatment of chronic cardiac dysfunction

• US 9,446,237 B2
• Filed: 09/22/2015
• Issued: 09/20/2016
• 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): Stigell, Theodore
• Assistant Examiner(s): MAHMOOD, NADIA AHMAD
• Application Number:
  US14/861,390
• Publication Number:
  US 20160008603A1
• Time in Patent Office: 364 Days
• Field of Search: 607/2, 607/6, 607/9, 607/62
• 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 1/36135 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 implantable medical device (IMD), the IMD comprising;

an electrode assembly; and

a neurostimulator coupled to the electrode assembly, said neurostimulator adapted to deliver a stimulation signal to a patient in the patient'"'"'s neural fulcrum zone, said stimulation signal comprising an ON time period and an OFF time period; and

an external system, the external system comprising;

an external heart rate sensor configured to acquire a heart rate signal from the patient; and

an external control system communicatively coupled to the heart rate sensor, the external control system being programmed to;

monitor a baseline heart rate signal acquired by the external heart rate sensor during the OFF time periods of the stimulation signal;

monitor a heart rate response signal acquired by the external heart rate sensor during the ON time periods of the stimulation signal; and

in response to the monitored baseline signal and the monitored response signal, to cause the IMD to adjust one or more parameters of the stimulation signal to deliver the stimulation signal in the patient'"'"'s neural fulcrum zone, wherein the neural fulcrum zone corresponds to a stimulation intensity during which a transition heart rate response is detected, said transition heart rate response being between tachycardia and bradycardia and comprising a heart rate change of between about 0% and a decrease of about 5%.

2. The neurostimulation system according to claim 1, wherein:

the IMD further comprises a first wireless communication interface; and

the external control system further comprises a second wireless communication interface configured to wirelessly communicate with the first wireless communication interface.

3. The neurostimulation system according to claim 2, wherein the IMD is programmed to receive stimulation parameters from the external control system via the wireless communication interface.

4. The neurostimulation system according to claim 1, wherein the external heart rate sensor is a separate device from the external control system, wherein the external heart rate sensor is in communication with the external control system.

5. The neurostimulation system according to claim 1, wherein the external control system is configured to cause the IMD to adjust one or more parameters of the stimulation signal to deliver the stimulation signal in the patient'"'"'s neural fulcrum zone by:

in response to detecting tachycardia, increasing a stimulation intensity; and

in response to detecting bradycardia, decreasing a stimulation intensity.

6. The neurostimulation system according to claim 1, wherein the external control system is programmed to monitor the baseline signals and the response signals substantially continuously.

7. The neurostimulation system according to claim 1, wherein the external control system is programmed to periodically monitor the baseline signals and the response signals at least once per day.

8. The neurostimulation system according to claim 1, wherein the external control system is programmed to monitor the baseline signals and the response signals in response to receiving a control input.

9. The neurostimulation system according to claim 8, wherein said control input comprises receipt of an input from a healthcare provider.

10. The neurostimulation system according to claim 1, wherein the external control system is programmed to decrease a stimulation intensity in response to receiving a control input.

11. The neurostimulation system according to claim 1, wherein the electrode assembly and the neurostimulator are adapted to deliver the stimulation signal to a vagus nerve of the patient.

12. A method of operating a neuromodulation system comprising an implantable medical device (IMD) and an external system, wherein the IMD comprises an electrode assembly and a neurostimulator coupled to the electrode assembly, and the external system comprises an external heart rate sensor and an external control system communicatively coupled to the heart rate sensor and the IMD, the method comprising:

acquiring a heart rate signal from a patient using the external heart rate sensor;

transmitting control signals from the external control system to the IMD to activate the neurostimulator to deliver a stimulation signal in the patient'"'"'s neural fulcrum zone, the stimulation signal comprising an ON time period and an OFF time period;

monitoring with the external control system a baseline heart rate signal acquired by the external heart rate sensor during the OFF time periods of the stimulation signal;

monitoring with the external control system a heart rate response signal acquired by the external heart rate sensor during the ON time periods of the stimulation signal; and

in response to the monitored baseline signal and the monitored response signal, adjusting one or more parameters of the stimulation signal to deliver the stimulation signal in the patient'"'"'s neural fulcrum zone, wherein the neural fulcrum zone corresponds to a stimulation intensity during which a transition heart rate response is detected, said transition heart rate response being between tachycardia and bradycardia and comprising a heart rate change of between about 0% and a decrease of about 5%.

13. The method according to claim 12, wherein said adjusting one or more parameters of the stimulation signal to deliver the stimulation signal in the patient'"'"'s neural fulcrum zone comprises:

in response to detecting tachycardia, increasing a stimulation intensity; and

in response to detecting bradycardia, decreasing a stimulation intensity.

14. The method according to claim 12, wherein said monitoring with the external control system the baseline signals and the response signals comprises recording the baseline signals and the response signals substantially continuously.

15. The method according to claim 12, wherein said monitoring with the external control system the baseline signals and the response signals comprises periodically monitoring the baseline signals and the response signals at least once per day.

16. The method according to claim 12, wherein said monitoring with the external control system the baseline signals and the response signals comprises monitoring the baseline signals and the response signals in response to receiving a control input.

17. The method according to claim 12, wherein said adjusting one or more parameters of the stimulation signal to deliver the stimulation signal in the patient'"'"'s neural fulcrum zone comprises wirelessly transmitting control signals from the external control system to the IMD to cause the IMD to adjust one or more parameters of the stimulation signal.

18. The method according to claim 12, further comprising:

receiving by the external control system a control input from a healthcare provider.

19. The method according to claim 18, further comprising:

in response to receiving by the external control system the control input from the healthcare provider, wirelessly transmitting control signals from the external control system to the IMD to cause the IMD to adjust one or more parameters of the stimulation signal.

20. The method according to claim 18, further comprising:

storing stimulation parameters in a non-transitory memory of the external control system.

21. The method according to claim 18, further comprising:

storing the heart rate signals from the external heart rate sensor in a non-transitory memory of the external control system.