IP Library Granted Patent US 11,185,698
Granted Patent B2
US 11,185,698 · App. 16/290,783 · Granted Nov 30, 2021

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 11,185,698
App. No.
16/290,783
Granted
Nov 30, 2021
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 (49)

1. A neurostimulation system, comprising:

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

an external control device operable by the 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, the 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 from the external control device, the first input indicating that one of an acceptable side effect level has been exceeded or a targeted physiological response has been achieved;

in response to the first input, decrease the frequency 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, pulse width, or duty cycle of the stimulation signal while maintaining the target output current; and

in response to a current parameter set of the stimulation signal reaching a target parameter set or receiving one or more additional inputs from the external control device, maintain the stimulation signal at the current parameter set.

2. The neurostimulation system of claim 1 , wherein the external control device is an external control magnet.

3. The neurostimulation system of claim 1 , wherein the target parameter set comprises a target frequency between 8 Hz and 12 Hz.

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

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 frequency and increase the output current by decreasing the frequency to about 5 Hz or less and increasing the output current.

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 frequency and increase the output current by decreasing the frequency, decreasing the output current for a period of time, and increasing the output current after an expiration of the period of time.

7. The neurostimulation system of claim 1 , wherein the stimulation parameters are further executable by the processor to:

in response to decreasing the frequency and increasing the output current, receive a second input from the external control device; and

in response to the second input, decrease the frequency and the pulse width and increase the output current of the stimulation signal.

8. A neurostimulation system, comprising:

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

an external control device operable by the 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, the 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 from the external control device, the first input indicating that one of an acceptable side effect level has been exceeded or a targeted physiological response has been achieved;

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

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

9. The neurostimulation system of claim 8 , wherein the external control device is an external control magnet.

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

11. The neurostimulation system of claim 8 , wherein the stimulation parameters are executable by the processor to, in response to the input, decrease the frequency and increase the output current by decreasing the frequency to about 5 Hz or less and increasing the output current.

12. The neurostimulation system of claim 8 , wherein the stimulation parameters are executable by the processor to, in response to the input, decrease the frequency and increase the output current by decreasing the frequency, decreasing the output current for a period of time, and increasing the output current after an expiration of the period of time.

13. The neurostimulation system of claim 8 , wherein the stimulation parameters are further executable by the processor to:

in response to decreasing the frequency and increasing the output current, receive a second input from the external control device; and

in response to the second input, decrease the frequency and pulse width and increase the output current of the stimulation signal.

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, the 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 from an external control device, the first input indicating that one of an acceptable side effect level has been exceeded or a targeted physiological response has been achieved;

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

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

in response to a current stimulation parameter set of the stimulation signal reaching a target parameter set or receiving, at the neurostimulator, one or more additional inputs from the external control device, maintaining the stimulation signal at the current parameter set.

15. The method of claim 14 , wherein the external control device is an external control magnet.

16. The method of claim 14 , wherein the target parameter set comprises a target frequency between 8 Hz and 12 Hz.

17. The method of claim 14 , wherein decreasing the frequency and increasing the output current comprises decreasing the frequency and increasing the output current while maintaining the decreased frequency, the pulse width, and the duty cycle of the stimulation signal.

18. The method of claim 14 , wherein decreasing the frequency and increasing the output current comprises decreasing the frequency to about 5 Hz or less and increasing the output current.

19. The method of claim 14 , wherein decreasing the frequency and increasing the output current comprises decreasing the frequency, decreasing the output current for a period of time, and increasing the output current after an expiration of the period of time.

20. The method of claim 14 , further comprising:

in response to decreasing the frequency and increasing the output current, receiving a second input from the external control device; and

in response to the second input, decreasing the frequency and the pulse width and increasing the output current 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 →
Continuity (3)
Continuation 15395872 · Dec 30, 2016
Continuation 14457807 · Aug 12, 2014
Related Publication 20190262615A1 · Aug 29, 2019