IP Library Granted Patent US 10,967,184
Granted Patent B2
US 10,967,184 · App. 16/265,765 · Granted Apr 6, 2021

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

Inventors: Imad Libbus (St. Paul, MN); Badri Amurthur (Los Gatos, CA); Bruce H. KenKnight (Maple Grove, MN); Jeffrey L. Ardell (Johnson City, TN)
Assignees: LivaNova USA, Inc.; East Tennessee State University
A61N1/36139A61N1/0551A61N1/36053A61N1/36114A61N1/36146A61N1/36171A61N1/3627A61N1/36157
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Quick Facts
Patent No.
US 10,967,184
App. No.
16/265,765
Granted
Apr 6, 2021
Kind
B2
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 (31)

1. A neurostimulator adapted to deliver a stimulation signal to a patient, said stimulation signal comprising an ON time and an OFF time, the neurostimulator comprising:

a control system comprising a processor configured to:

activate the neurostimulator to deliver the stimulation signal;

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

during the ON time of the stimulation signal, acquire a response signal comprising a heart rate response from the heart rate sensor; 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 neurostimulator of claim 1 , wherein the control system is further configured to periodically record the baseline signals and the response signals for a period of at least one week.

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

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

5. The neurostimulator of claim 1 , wherein the control system is configured to transmit recorded baseline signals and response signals to an external computing device.

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

7. The neurostimulator of claim 1 , wherein the stimulation signals are vagus nerve stimulation signals.

8. The neurostimulator of claim 1 , wherein the control system is configured to acquire the baseline signal after a delay period following completion of the ON time of the stimulation signal.

9. The neurostimulator of claim 1 , wherein the control system is configured to acquire the response signal after a delay period following initiation of the ON time of the stimulation signal.

10. The neurostimulator of claim 1 , wherein the control system is further configured 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.

11. A method of operating a neurostimulator adapted to deliver a stimulation signal to a patient, said stimulation signal comprising an ON time and an OFF time, the method comprising:

activating the neurostimulator to deliver the stimulation signal;

during the OFF time of the stimulation signal, acquiring a baseline signal comprising a baseline heart rate from a heart rate sensor;

during the ON time of the stimulation signal, acquiring a response signal comprising a heart rate response from the heart rate sensor; 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 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 transmitting 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 the stimulation signals are vagus nerve stimulation signals.

18. The method of claim 11 , wherein acquiring the baseline signal comprises acquiring the baseline signal after a delay period following completion of the ON time of the stimulation signal.

19. The method of claim 11 , wherein acquiring the response signal comprises acquiring the response signal after a delay period following initiation of the ON time of the stimulation signal.

20. 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.

Assignments (5)
RELEASE OF SECURITY INTEREST Recorded Sep 20, 2021
From: ACF FINCO I LP
To: LIVANOVA USA, INC.
Reel/Frame 057552/0378 →
SECURITY INTEREST Recorded Aug 16, 2021
From: LIVANOVA USA, INC.
To: GOLDMAN SACHS BANK USA, AS COLLATERAL AGENT
Reel/Frame 057188/0001 →
RELEASE OF SECURITY INTEREST Recorded Aug 16, 2021
From: ARES CAPITAL CORPORATION, AS AGENT FOR THE LENDERS
To: LIVANOVA USA, INC.
Reel/Frame 057189/0001 →
PATENT SECURITY AGREEMENT Recorded Dec 30, 2020
From: LIVANOVA USA, INC.
To: ACF FINCO I LP, AS COLLATERAL AGENT
Reel/Frame 054881/0784 →
PATENT SECURITY AGREEMENT Recorded Jun 17, 2020
From: LIVANOVA USA, INC.
To: ARES CAPITAL CORPORATION, AS COLLATERAL AGENT
Reel/Frame 053673/0675 →