Responsive neurostimulation for the treatment of chronic cardiac dysfunction

• US 9,272,143 B2
• Filed: 05/07/2014
• Issued: 03/01/2016
• 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): Lavert, Nicole F
• Assistant Examiner(s): MAHMOOD, NADIA AHMAD
• Application Number:
  US14/271,714
• Publication Number:
  US 20150321001A1
• Time in Patent Office: 664 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. An implantable medical device (IMD), comprising:

an electrode assembly;

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 and an OFF time;

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

a control system coupled to the neurostimulator and the heart rate sensor, said control system being programmed to;

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

monitor a heart rate response signal acquired by the 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, adjust one or more parameters of the stimulation signal to deliver the stimulation signal in the patient'"'"'s neural fulcrum zone, 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 0% and 5%.

2. The IMD according to claim 1, 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.

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

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

5. The IMD according to claim 1, wherein the control system is programmed to monitor the baseline signals and the response signals in response to receiving a control input from an external device.

6. The IMD according to claim 5, wherein said control input comprises detection of a magnetic field from the external device.

7. The IMD according to claim 5, wherein said control input comprises receipt of a wireless data signal from the external device.

8. The IMD according to claim 1, wherein the control system is further programmed to decrease a stimulation intensity in response to receiving a control input from an external device.

9. The IMD according to claim 8, wherein said control input comprises detection of a magnetic field from the external device.

10. The IMD according to claim 8, wherein said control input comprises detection of a wireless data signal from the external device.

11. The IMD 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 an implantable medical device (IMD) comprising a heart rate sensor configured to acquire a heart rate signal from the patient and a neurostimulator coupled to an electrode assembly, said neurostimulator adapted to deliver a stimulation signal to a patient, the method comprising:

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

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

monitoring a heart rate response signal acquired by the 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 0% and 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 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 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 the baseline signals and the response signals comprises monitoring the baseline signals and the response signals in response to receiving a control input from an external device.

17. The method according to claim 16, wherein said control input comprises detection of a magnetic field from the external device.

18. The method according to claim 16, wherein said control input comprises receipt of a wireless data signal from the external device.