IP Library Granted Patent US 11,918,813
Granted Patent B2
US 11,918,813 · App. 17/537,198 · Granted Mar 5, 2024

Neurostimulation titration process

Inventors: Imad Libbus (St. Paul, MN); Bruce H. KenKnight (Maple Grove, MN); Badri Amurthur (Los Gatos, CA)
Assignee: LivaNova USA, Inc.
A61N1/36157A61B5/0205A61B5/0245A61B5/4836A61N1/36114A61N1/36132A61N1/36139A61N1/36171A61N1/36175A61B5/02055
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Quick Facts
Patent No.
US 11,918,813
App. No.
17/537,198
Granted
Mar 5, 2024
Kind
B2
Abstract

Systems and methods are provided for delivering neurostimulation therapies to patients for treating chronic heart failure. A titration process is used to gradually increase the stimulation intensity to a desired therapeutic level. This titration process can minimize the amount of time required to complete titration so as to begin delivery of the stimulation at therapeutically desirable levels.

Claims (45)

1. A neurostimulation system, comprising:

a neurostimulator adapted to deliver a stimulation signal to a patient; and

a processor and a memory storing stimulation parameters executable by the processor to:

at an initial titration session, activate the neurostimulator to deliver the stimulation signal with an initial parameter set comprising an output current, a frequency, a pulse width, and a duty cycle;

increase the output current of the stimulation signal;

receive a first input indicating that an acceptable side effect level has been exceeded;

in response to the first input, decrease the pulse width and increase the output current of the stimulation signal;

receive a second input indicating that a target physiological response has been achieved; and

in response to the second input, maintain the stimulation signal at a current parameter set.

2. The neurostimulation system of claim 1 , wherein the target physiological response is a target heart rate change.

3. The neurostimulation system of claim 2 , wherein the target heart rate change is a heart rate change of between 4% and 5%.

4. The neurostimulation system of claim 1 , wherein the first input is received from an external control device operable by the patient.

5. The neurostimulation system of claim 1 , wherein the stimulation parameters are executable by the processor to, in response to the first input, decrease the pulse width and increase the output current by decreasing the pulse width and increasing the output current while maintaining the decreased pulse width, the frequency, and the duty cycle of the stimulation signal.

6. The neurostimulation system of claim 1 , wherein the stimulation parameters are executable by the processor to, in response to the first input, decrease the pulse width and increase the output current by decreasing the pulse width to 150 μsec or less and increasing the output current.

7. The neurostimulation system of claim 1 , wherein the second input is received from an implanted heart rate monitor.

8. A neurostimulation system, comprising:

a neurostimulator adapted to deliver a stimulation signal to a patient; and

a processor and a memory storing stimulation parameters executable by the processor to:

at an initial titration session, activate the neurostimulator to deliver the stimulation signal with an initial parameter set comprising an output current, a frequency, a pulse width, and a duty cycle;

increase the output current of the stimulation signal;

receive a first input indicating that an acceptable side effect level has been exceeded;

in response to the first input, decrease the pulse width and increase the output current of the stimulation signal;

in response to the output current reaching a target output current, increase at least one of the frequency, the pulse width, or the duty cycle of the stimulation signal while maintaining the target output current;

receive a second input indicating that a target physiological response has been achieved; and

in response to the second input, maintain the stimulation signal at a current parameter set.

9. The neurostimulation system of claim 8 , wherein the target physiological response is a target heart rate change.

10. The neurostimulation system of claim 9 , wherein the target heart rate change is a heart rate change of between 4% and 5%.

11. The neurostimulation system of claim 8 , wherein the first input is received from an external control device operable by the patient.

12. The neurostimulation system of claim 8 , wherein the stimulation parameters are executable by the processor to, in response to the first input, decrease the pulse width and increase the output current by decreasing the pulse width and increasing the output current while maintaining the decreased pulse width, the frequency, and the duty cycle of the stimulation signal.

13. The neurostimulation system of claim 8 , wherein the stimulation parameters are executable by the processor to, in response to the first input, decrease the pulse width and increase the output current by decreasing the pulse width to 150 μsec or less and increasing the output current.

14. A method of operating a neurostimulation system comprising a neurostimulator adapted to deliver a stimulation signal to a patient, comprising:

at an initial titration session, activating the neurostimulator to deliver the stimulation signal with an initial parameter set comprising an output current, a frequency, a pulse width, and a duty cycle;

increasing the output current of the stimulation signal;

receiving a first input indicating that an acceptable side effect level has been exceeded;

in response to the first input, decreasing the pulse width and increasing the output current;

receiving a second input indicating that a target physiological response has been achieved; and

in response to the second input, maintaining the stimulation signal at a current parameter set.

15. The method of claim 14 , wherein the target physiological response is a target heart rate change.

16. The method of claim 15 , wherein the target heart rate change is a heart rate change of between 4% and 5%.

17. The method of claim 14 , wherein the first input is received from an external control device operable by the patient.

18. The method of claim 14 , further comprising:

in response to the first input, decreasing the pulse width and increasing the output current by decreasing the pulse width and increasing the output current while maintaining the decreased pulse width, the frequency, and the duty cycle of the stimulation signal.

19. The method of claim 14 , further comprising:

in response to the first input, decreasing the pulse width and increasing the output current by decreasing the pulse width to 150 μsec or less and increasing the output current.

20. The method of claim 14 , wherein the second input is received from an implanted heart rate monitor.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 21, 2023
From: LIBBUS, IMAD; KENKNIGHT, BRUCE H.; AMURTHUR, BADRI
To: CYBERONICS, INC.
Reel/Frame 065931/0950 →
CHANGE OF NAME Recorded Dec 21, 2023
From: CYBERONICS, INC.
To: LIVANOVA USA, INC.
Reel/Frame 066094/0132 →
Continuity (4)
Continuation 16290783 · Mar 1, 2019
Continuation 15395872 · Dec 30, 2016
Continuation 14457807 · Aug 12, 2014
Related Publication 20220080207A1 · Mar 17, 2022