IP Library Granted Patent US 12,157,008
Granted Patent B2
US 12,157,008 · App. 17/716,807 · Granted Dec 3, 2024

Responsive neurostimulation 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
A61N1/36114A61N1/36053A61N1/36135A61N1/36139A61N1/3615A61N1/37217A61N1/37264
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Quick Facts
Patent No.
US 12,157,008
App. No.
17/716,807
Granted
Dec 3, 2024
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 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 (38)

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

delivering stimulation to a nerve of a patient using a first set of stimulation parameters;

detecting a first heart rate response caused by the first set of stimulation parameters, the first heart rate response being within a neural fulcrum zone defined as a heart rate reduction between a baseline heart rate and a predefined threshold;

subsequent to detecting the first heart rate response, detecting a second heart rate response caused by the first set of stimulation parameters, the second heart rate response being outside of the neural fulcrum zone; and

delivering stimulation to the nerve of the patient using a second set of stimulation parameters based on the second heart rate response.

2. The method of claim 1 , wherein, in response to the second heart rate response being a heart rate increase above the baseline heart rate, the second set of stimulation parameters has a higher intensity than the first set of stimulation parameters.

3. The method of claim 1 , wherein, in response to the second heart rate response being a heart rate reduction below the predefined threshold, the second set of stimulation parameters has a lower intensity than the first set of stimulation parameters.

4. The method of claim 1 , wherein detecting the second heart rate response occurs in response to a control input.

5. The method of claim 4 , wherein the control input comprises an input from at least one of a programmer or a magnet.

6. The method of claim 1 , wherein detecting the second heart rate response occurs during a continuous monitoring of the patient's heart rate.

7. The method of claim 1 , wherein detecting the second heart rate response occurs during a periodic monitoring of the patient's heart rate.

8. The method of claim 1 , wherein the predefined threshold is a 5% heart rate reduction from the baseline heart rate.

9. 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 to a nerve of a patient using a first set of stimulation parameters;

detect a first heart rate response caused by the first set of stimulation parameters, the first heart rate response being within a neural fulcrum zone defined as a heart rate reduction between a baseline heart rate and a predefined threshold;

subsequent to detecting the first heart rate response, detect a second heart rate response caused by the first set of stimulation parameters, the second heart rate response being outside of the neural fulcrum zone; and

deliver stimulation to the nerve of the patient using a second set of stimulation parameters based on the second heart rate response, wherein, in response to the second heart rate response being a heart rate increase above the baseline heart rate, the second set of stimulation parameters has a higher intensity than the first set of stimulation parameters and, in response to the second heart rate response being a heart rate reduction below the predefined threshold, the second set of stimulation parameters has a lower intensity than the first set of stimulation parameters.

10. The neurostimulation system of claim 9 , wherein detecting the second heart rate response occurs in response to a control input.

11. The neurostimulation system of claim 10 , wherein the control input comprises an input from at least one of a programmer or a magnet.

12. The neurostimulation system of claim 9 , wherein detecting the second heart rate response occurs during a continuous monitoring of the patient's heart rate.

13. The neurostimulation system of claim 9 , wherein detecting the second heart rate response occurs during a periodic monitoring of the patient's heart rate.

14. The neurostimulation system of claim 9 , wherein the predefined threshold is a 5% heart rate reduction from the baseline heart rate.

15. 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 to a nerve of a patient using a first set of stimulation parameters;

detect a first heart rate response caused by the first set of stimulation parameters, the first heart rate response being within a neural fulcrum zone defined as a heart rate reduction between a baseline heart rate and a predefined threshold;

subsequent to detecting the first heart rate response, detect a second heart rate response caused by the first set of stimulation parameters, the second heart rate response being outside of the neural fulcrum zone; and

deliver stimulation to the nerve of the patient using a second set of stimulation parameters based on the second heart rate response.

16. The neurostimulator of claim 15 , wherein, in response to the second heart rate response being a heart rate increase above the baseline heart rate, the second set of stimulation parameters has a higher intensity than the first set of stimulation parameters.

17. The neurostimulator of claim 15 , wherein, in response to the second heart rate response being a heart rate reduction below the predefined threshold, the second set of stimulation parameters has a lower intensity than the first set of stimulation parameters.

18. The neurostimulator of claim 15 , wherein detecting the second heart rate response occurs in response to a control input.

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

20. The neurostimulator of claim 15 , wherein detecting the second heart rate response occurs during a continuous monitoring of the patient's heart rate.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 5, 2022
From: LIBBUS, IMAD; AMURTHUR, BADRI; KENKNIGHT, BRUCE H.
To: CYBERONICS, INC.
Reel/Frame 060728/0964 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 5, 2022
From: ARDELL, JEFFREY L.
To: EAST TENNESSEE STATE UNIVERSITY
Reel/Frame 060729/0106 →
CHANGE OF NAME Recorded Aug 5, 2022
From: CYBERONICS, INC.
To: LIVANOVA USA, INC.
Reel/Frame 061099/0516 →