Neurostimulation and recording of physiological response for the treatment of chronic cardiac dysfunction

• US 10,195,438 B2
• Filed: 10/13/2017
• Issued: 02/05/2019
• Est. Priority Date: 04/25/2014
• 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, 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:
  US15/783,941
• Publication Number:
  US 20180126170A1
• Time in Patent Office: 480 Days
• Field of Search: 607 62, 607 2, 607 6, 607 9
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• 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 1/36146 specified by the stimulation parameters
• CPC Class Codes: A61N 1/36157 Current A61N1/3616 takes precedence
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy

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 recording the patient'"'"'s response to the neurostimulation therapy on an ambulatory basis over extended periods of time.

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, 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; and

a control system coupled to the neurostimulator and the heart rate sensor and configured to;

activate the neurostimulator to deliver the stimulation signal;

during the OFF time of the stimulation signal, activate the heart rate sensor to acquire a baseline signal comprising a baseline heart rate;

during the ON time of the stimulation signal, activate the heart rate sensor to acquire a response signal comprising a heart rate response; and

change an intensity of the stimulation signal, based on the baseline signal and the response signal, to cause a transition heart rate response in the patient, the transition heart rate response being between tachycardia and bradycardia and comprising a heart rate change between the baseline heart rate and the heart rate response that is less than a predefined threshold.

2. The IMD of claim 1, wherein the control system is programmed to periodically record the baseline signals and the response signals for a period of at least one week.

3. The IMD of claim 1, wherein the control system is programmed to periodically record the baseline signals and the response signals for a period of at least one month.

4. The IMD of claim 1, wherein the control system is programmed to periodically record the baseline signals and the response signals for a period of at least one year.

5. The IMD of claim 1, further comprising a communications interface configured to wirelessly transmit recorded baseline signals and response signals to an external computing device.

6. The IMD of claim 1, wherein the stimulation signals are configured to treat a chronic cardiac dysfunction.

7. The IMD of claim 1, wherein the control system is programmed to activate the heart rate sensor to acquire the baseline signal after a delay period following completion of the ON time of the stimulation signal.

8. The IMD of claim 1, wherein the control system is programmed to activate the heart rate sensor to acquire the response signal after a delay period following initiation of the ON time of the stimulation signal.

9. The IMD of claim 1, wherein the control system is programmed to calculate a baseline signal average of a plurality of OFF times of the stimulation signal and to calculate a response signal average of a plurality of ON times of the stimulation signal.

10. The IMD of claim 1, wherein the electrode assembly and the neurostimulator are adapted to deliver the stimulation signal to a vagus nerve of the patient.

11. 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 and adapted to deliver a stimulation signal to a patient, the method comprising:

activating the neurostimulator to deliver the stimulation signal;

during the OFF time of the stimulation signal, activating the heart rate sensor to acquire a baseline signal comprising a baseline heart rate;

during the ON time of the stimulation signal, activating the heart rate sensor to acquire a response signal comprising a heart rate response; and

changing an intensity of the stimulation signal, based on the baseline signal and the response signal, to cause a transition heart rate response in the patient, the transition heart rate response being between tachycardia and bradycardia and comprising a heart rate change between the baseline heart rate and the heart rate response that is less than a predefined threshold.

12. The method of claim 11, further comprising periodically recording the baseline signals and the response signals for a period of at least one week.

13. The method of claim 11, further comprising periodically recording the baseline signals and the response signals for a period of at least one month.

14. The method of claim 11, further comprising periodically recording the baseline signals and the response signals for a period of at least one year.

15. The method of claim 11, further comprising wirelessly transmitting the recorded baseline signals and response signals to an external computing device.

16. The method of claim 11, wherein the stimulation signals are configured to treat a chronic cardiac dysfunction.

17. The method of claim 11, wherein activating the heart rate sensor to acquire the baseline signal comprises activating the heart rate sensor to acquire the baseline signal after a delay period following completion of the ON time of the stimulation signal.

18. The method of claim 11, wherein activating the heart rate sensor to acquire the response signal comprises activating the heart rate sensor to acquire the response signal after a delay period following initiation of the ON time of the stimulation signal.

19. The method of claim 11, further comprising:

calculating a baseline signal average of a plurality of OFF times of the stimulation signal; and

calculating a response signal average of a plurality of ON times of the stimulation signal.

20. The method of claim 11, wherein activating the neurostimulator comprises activating the neurostimulator to deliver the stimulation signal to a vagus nerve of the patient.