IP Library Granted Patent US 11,167,142
Granted Patent B2
US 11,167,142 · App. 16/130,799 · Granted Nov 9, 2021

Customizable titration for an implantable neurostimulator

Inventors: Scott Stubbs (Maple Grove, MN); Imad Libbus (St. Paul, MN); Scott Mazar (Woodbury, MN); Bruce KenKnight (Maple Grove, MN); Badri Amurthur (Houston, TX)
Assignee: LivaNova USA, Inc.
A61N1/36139A61N1/37235G16H20/30A61N1/365A61N1/36114A61N1/36132A61N1/36157A61N1/36171A61N1/36175A61N1/37223A61N1/37247G16H40/63
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Quick Facts
Patent No.
US 11,167,142
App. No.
16/130,799
Granted
Nov 9, 2021
Kind
B2
Abstract

Systems and methods for customizable titration of an implantable neurostimulator are provided. A method of titrating a neurostimulation signal delivered to a patient from an implantable pulse generator includes delivering a first neurostimulation signal with a first set of parameters, increasing a first value of the first neurostimulation signal at a first rate for a first period of time while delivering the first neurostimulation signal, ceasing delivery of the first neurostimulation signal when the first value reaches a first target value, delivering a second neurostimulation signal with a second set of parameters, and increasing the second neurostimulation signal at a second rate for a second period of time while delivering the second neurostimulation signal.

Claims (47)

1. A method of titrating a neurostimulation signal delivered to a patient from an implantable pulse generator, the method comprising:

delivering a first neurostimulation signal to the patient with a first titration aggressiveness profile having a first rate of titration and a first set of parameters, the first set of parameters having a first value for each of output current, frequency, pulse width, and duty cycle, the first set of parameters further having a first range of values for at least one of output current, frequency, pulse width, or duty cycle, the first range of values including the first value and a first target value;

increasing the first neurostimulation signal from the first value of the first range of values toward the first target value at the first rate of titration for a first period of time while delivering the first neurostimulation signal;

reaching the first target value while delivering the first neurostimulation signal and ceasing the delivering of the first neurostimulation signal upon reaching the first target value;

delivering a second neurostimulation signal to the patient with a second titration aggressiveness profile having a second rate of titration and a second set of parameters, the second set of parameters having a second value for each of output current, frequency, pulse width, and duty cycle, the second set of parameters further having a second range of values for the at least one of output current, frequency, pulse width, or duty cycle, the second range of values including the second value and a second target value, the second value of the second range of values being equal to the first target value; and

increasing the second neurostimulation signal, beginning from the second value of the second range of values, toward the second target value at the second rate of titration for a second period of time while delivering the second neurostimulation signal, the second rate of titration being different than the first rate of titration.

2. The method of claim 1 , wherein the first target value comprises an output current of 0.75 mA.

3. The method of claim 1 , further comprising:

reaching the second target value while delivering the second neurostimulation signal and ceasing the delivering of the second neurostimulation signal upon reaching the second target value;

delivering a third neurostimulation signal with a third titration aggressiveness profile having a third rate of titration and a third set of parameters, the third set of parameters having a third value for each of output current, frequency, pulse width, and duty cycle, the third set of parameters further having a third range of values for the at least one of output current, frequency, pulse width, or duty cycle, the third range of values including the third value and a third target value, the third value of the third range of values being equal to the second target value; and

increasing the third neurostimulation signal from the third value of the third range of values toward the third target value at the third rate of titration for a third period of time while delivering the third neurostimulation signal.

4. The method of claim 3 , wherein the third rate of titration is equal to the first rate of titration.

5. The method of claim 3 , wherein the second target value comprises an output current of 1.0 mA.

6. The method of claim 1 , wherein the second period of time is greater than the first period of time.

7. The method of claim 6 , wherein the second period of time is between 1 day and 7 days.

8. The method of claim 1 , wherein the second values of the second set of parameters other than the at least one of output current, frequency, pulse width, or duty cycle having the second range of values are equal to the corresponding first values of the first set of parameters.

9. A neurostimulation system capable of providing a neurostimulation signal to a patient, the neurostimulation system comprising:

an implantable pulse generator that generates the neurostimulation signal according to a titration protocol executed by a processor;

an electrode configured to deliver the neurostimulation signal to the patient; and a lead coupling the electrode to the implantable pulse generator, wherein the processor is configured to implement the titration protocol by issuing control signals that allow the implantable pulse generator to:

deliver a first neurostimulation signal to the patient with a first titration aggressiveness profile having a first rate of titration and a first set of parameters, the first set of parameters having a first value for each of output current, frequency, pulse width, and duty cycle, the first set of parameters further having a first range of values for at least one of output current, frequency, pulse width, or duty cycle, the first range of values including the first value and a first target value;

increase the first neurostimulation signal from the first value of the first range of values toward the first target value at the first rate of titration for a first period of time while delivering the first neurostimulation signal;

reach the first target value while delivering the first neurostimulation signal and ceasing the delivering of the first neurostimulation signal upon reaching the first target value;

deliver a second neurostimulation signal to the patient with a second titration aggressiveness profile having a second rate of titration and a second set of parameters, the second set of parameters having a second value for each of output current, frequency, pulse width, and duty cycle, the second set of parameters further having a second range of values for the at least one of output current, frequency, pulse width, or duty cycle, the second range of values including the second value and a second target value, the second value of the second range of values being equal to the first target value; and

increase the second neurostimulation signal, beginning from the second value of the second range of values, toward the second target value at the second rate of titration for a second period of time while delivering the second neurostimulation signal, the second rate of titration being different than the first rate of titration.

10. The neurostimulation system of claim 9 , wherein the first target value comprises an output current of approximately 0.75 mA.

11. The neurostimulation system of claim 9 , wherein the processor is further configured to issue additional control signals that allow the implantable pulse generator to:

cease delivery of the second neurostimulation signal when the second value reaches a second target value;

deliver a third neurostimulation signal with a third set of parameters, the third set of parameters having a third value for at least one of output current, frequency, pulse width, or duty cycle, the third value being equal to the second target value; and

increase the third neurostimulation signal at a third rate for a third period of time while delivering the third neurostimulation signal.

12. The neurostimulation system of claim 11 , wherein the third rate is equal to the first rate.

13. The neurostimulation system of claim 11 , wherein the second target value comprises an output current of approximately 1.0 mA.

14. The neurostimulation system of claim 9 , wherein the second period of time is greater than the first period of time.

15. The neurostimulation system of claim 14 , wherein the second period of time is between 1 day and 7 days.

16. A method of titrating a neurostimulation signal delivered to a patient from an implantable pulse generator, the method comprising:

delivering a first neurostimulation signal to the patient with a first titration aggressiveness profile having a first rate of titration and a first set of parameters, the first set of parameters having a first value for each of output current, frequency, pulse width, and duty cycle, the first set of parameters further having a first range of values for at least one of output current, frequency, pulse width, or duty cycle, the first range of values including the first value and a first target value;

increasing the first neurostimulation signal from the first value of the first range of values toward the first target value at the first rate of titration for a first period of time while delivering the first neurostimulation signal;

reaching the first target value while delivering the first neurostimulation signal and ceasing the delivering of the first neurostimulation signal upon reaching the first target value;

delivering a second neurostimulation signal to the patient with a second titration aggressiveness profile having a second rate of titration and a second set of parameters, the second set of parameters having a second value for each of output current, frequency, pulse width, and duty cycle, the second set of parameters further having a second range of values for the at least one of output current, frequency, pulse width, or duty cycle, the second range of values including the second value and a second target value, the second value of the second range of values being equal to the first target value; and

increasing the second neurostimulation signal, beginning from the second value of the second range of values, toward the second target value at the second rate of titration for a second period of time while delivering the second neurostimulation signal, the second rate being lower than the first rate, the second period of time being greater than the first period of time.

17. The method of claim 16 , wherein the first target value comprises an output current of approximately 0.75 mA.

18. The method of claim 16 , further comprising:

ceasing delivery of the second neurostimulation signal when the second value reaches a second target value;

delivering a third neurostimulation signal with a third set of parameters, the third set of parameters having a third value for at least one of output current, frequency, pulse width, or duty cycle, the third value being equal to the second target value; and

increasing the third neurostimulation signal at a third rate for a third period of time while delivering the third neurostimulation signal.

19. The method of claim 18 , wherein the third rate is equal to the first rate.

20. The method of claim 18 , wherein the second target value comprises an output current of approximately 1.0 mA.

21. The method of claim 16 , wherein the second period of time is between 1 day and 7 days.

Assignments (8)
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 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 23, 2020
From: STUBBS, SCOTT; LIBBUS, IMAD; MAZAR, SCOTT; KENKNIGHT, BRUCE
To: LIVANOVA USA, INC.
Reel/Frame 053858/0391 →
CHANGE OF NAME Recorded Sep 23, 2020
From: CYBERONICS, INC.
To: LIVANOVA USA, INC.
Reel/Frame 053858/0511 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 23, 2020
From: AMURTHUR, BADRI
To: LIVANOVA USA, INC.
Reel/Frame 053858/0491 →
PATENT SECURITY AGREEMENT Recorded Jun 17, 2020
From: LIVANOVA USA, INC.
To: ARES CAPITAL CORPORATION, AS COLLATERAL AGENT
Reel/Frame 053673/0675 →