IP Library Granted Patent US 10,967,185
Granted Patent B2
US 10,967,185 · App. 16/693,005 · Granted Apr 6, 2021

Customizable titration for an implantable neurostimulator

Inventors: Scott Stubbs (Maple Grove, MN); Imad Libbus (St. Paul, MN); Scott Mazar (Woodbury, MN); Bruce H. 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 10,967,185
App. No.
16/693,005
Granted
Apr 6, 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 (87)

1. A neurostimulation system comprising:

an external programmer having stored thereon a plurality of titration aggressiveness profiles, each titration aggressiveness profile of the plurality of titration aggressiveness profiles having a rate of titration and a range of values for each of a plurality of parameters, the plurality of aggressiveness profiles including at least a first titration aggressiveness profile and a second titration aggressiveness profile;

an implantable medical device (IMD) comprising a neurostimulator coupled to an electrode assembly, the neurostimulator comprising:

an implantable pulse generator configured to generate a neurostimulation signal delivered to a patient via the electrode assembly; and

a control system programmed to:

receive the plurality of titration aggressiveness profiles, including the first titration aggressiveness profile and the second titration aggressiveness profile, from the external programmer;

deliver the neurostimulation signal at a first location on the first titration aggressiveness profile, the first location being a first set of parameters having two or more first values for two or more of output current, frequency, pulse width, or duty cycle of the neurostimulation signal;

increase the two or more of output current, frequency, pulse width, or duty cycle from the two or more first values towards two or more target values according to the first aggressiveness profile;

receive a feedback signal from the patient indicating an adverse effect from the neurostimulation signal at an intermediate location on the first aggressiveness profile, the intermediate location being an intermediate set of parameters having two or more intermediate values for the two or more of output current, frequency, pulse width, or duty cycle of the neurostimulation signal, the two or more intermediate values being between the two or more first values and the two or more target values; and

in response to the feedback signal:

identify a second location on the second titration aggressiveness profile, the second location being a second set of parameters having two or more second values for the two or more of output current, frequency, pulse width, or duty cycle that are less than or equal to the two or more intermediate values;

deliver the neurostimulation signal at the second location on the second titration aggressiveness profile; and

increase the two or more of output current, frequency, pulse width, or duty cycle from the two or more second values towards the two or more target values according to the second aggressiveness profile;

wherein the second titration aggressiveness profile corresponds to a less aggressive titration and the first titration aggressiveness profile corresponds to a more aggressive titration, the more aggressive titration defined by at least one of the following as compared to the less aggressive titration:

 a shorter time interval for a transition from the first set of parameters to the two or more target values,

 one or more greater target values, or

 greater increment values between the two or more first values and the two or more target values.

2. The neurostimulation system of claim 1 , wherein the plurality of titration aggressiveness profiles further includes a third titration aggressiveness profile and the control system is further programmed to:

receive the third titration aggressiveness profile from the external programmer;

receive a second feedback signal from the patient indicating an adverse effect from the neurostimulation signal at a second intermediate location on the second aggressiveness profile, the second intermediate location being a second intermediate set of parameters having two or more second intermediate values for the two or more of output current, frequency, pulse width, or duty cycle of the neurostimulation signal, the two or more second intermediate values being between the two or more intermediate values and the two or more target values;

identify a third location on a third titration aggressiveness profile, the third location being a third set of parameters having two or more third values for the two or more of output current, frequency, pulse width, or duty cycle that are less than or equal to the two or more second intermediate values;

deliver the neurostimulation signal at the third location on the third titration aggressiveness profile; and

increase the at least two of output current, frequency, pulse width, or duty cycle from the two or more third values towards the two or more target values according to the third aggressiveness profile.

3. The neurostimulation system of claim 2 , wherein the third titration aggressiveness profile corresponds to a least aggressive titration, the less aggressive titration of the second titration aggressiveness profile defined by at least one of the following as compared to the least aggressive titration of the third titration aggressiveness profile:

a shorter time interval for a transition from the first set of parameters to the target value,

one or more greater target values, or

greater increment values between the first value and the target value.

4. The neurostimulation system of claim 1 , wherein the control system is programmed to modify the neurostimulation signal after receiving the feedback signal a plurality of times.

5. The neurostimulation system of claim 1 , wherein the neurostimulator further comprises a magnet detection circuit configured to detect a presence of a magnet in proximity of the implantable pulse generator; and

wherein the control system is configured to receive the feedback signal by detecting the feedback signal using the magnet detection circuit.

6. The neurostimulation system of claim 1 , wherein the control circuit is further programmed to transmit, via the implantable pulse generator, receipt of the feedback signal to an external device.

7. The neurostimulation system of claim 1 , wherein the control system is further programmed to:

increase the two or more of output current, frequency, pulse width, or duty cycle from the two or more second values towards the two or more target values at a first rate until the two or more of output current, frequency, pulse width, or duty cycle reaches two or more intermediate target values; and

subsequently increase the two or more of output current, frequency, pulse width, or duty cycle from the two or more intermediate target values towards the two or more target values at a second rate.

8. The neurostimulation system of claim 7 , wherein the second rate is lower than the first rate.

9. The neurostimulation system of claim 7 , wherein the two or more intermediate target values are two or more first intermediate target values, and wherein the control system is further programmed to:

increase the two or more of output current, frequency, pulse width, or duty cycle from the two or more first intermediate target values towards the two or more target values at a second rate until the two or more of output current, frequency, pulse width, or duty cycle reach two or more second intermediate target values; and

subsequently increase the two or more of output current, frequency, pulse width, or duty cycle from the two or more second intermediate target values towards the two or more target values at a third rate.

10. The neurostimulation system of claim 9 , wherein the third rate is equal to the first rate.

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

receiving a plurality of titration aggressiveness profiles from an external programmer, each titration aggressiveness profile of the plurality of titration aggressiveness profiles having a rate of titration and a range of values for each of a plurality of parameters, the plurality of titration aggressiveness profiles including at least a first titration aggressiveness profile and a second titration aggressiveness profile;

delivering the neurostimulation signal at a first location on the first titration aggressiveness profile, the first location being a first set of parameters having two or more first values for two or more of output current, frequency, pulse width, or duty cycle of the neurostimulation signal;

increasing the two or more of output current, frequency, pulse width, or duty cycle from the two or more first values towards two or more target values according to the first titration aggressiveness profile;

receiving a feedback signal from the patient indicating an adverse effect from the neurostimulation signal at an intermediate location on the first aggressiveness profile, the intermediate location being an intermediate set of parameters having two or more intermediate values for the two or more of output current, frequency, pulse width, or duty cycle of the neurostimulation signal, the two or more intermediate values being between the two or more first values and the two or more target values; and

in response to receiving the feedback signal:

identifying a second location on the second titration aggressiveness profile, the second location being a second set of parameters having two or more second values for the two or more of output current, frequency, pulse width, or duty cycle that are less than or equal to the two or more intermediate values;

delivering the neurostimulation signal at the second location on the second titration aggressiveness profile; and

increasing the two or more of output current, frequency, pulse width, or duty cycle from the two or more second values towards the two or more target values according to the second aggressiveness profile;

wherein the second titration aggressiveness profile corresponds to a less aggressive titration and the first titration aggressiveness profile corresponds to a more aggressive titration, the more aggressive titration defined by at least one of the following as compared to the less aggressive titration:

a shorter time interval for a transition from the first set of parameters to the two or more target values,

one or more greater target values, or

greater increment values between the two or more first values and the two or more target values.

12. The method of claim 11 , wherein the plurality of titration aggressiveness profiles further includes a third titration aggressiveness profile, the method further comprising:

receiving the third titration aggressiveness profile from the external programmer;

receiving a second feedback signal from the patient indicating an adverse effect from the neurostimulation signal at a second intermediate location on the second aggressiveness profile, the second intermediate location being a second intermediate set of parameters having two or more second intermediate values for the two or more of output current, frequency, pulse width, or duty cycle of the neurostimulation signal, the two or more second intermediate values being between the two or more intermediate values and the two or more target values;

identifying a third location on a third titration aggressiveness profile, the third location being a third set of parameters having two or more third values for the two or more of output current, frequency, pulse width, or duty cycle that are less than or equal to the two or more second intermediate values;

delivering the neurostimulation signal at the third location on the third titration aggressiveness profile; and

increasing the two or more of output current, frequency, pulse width, or duty cycle from the two or more second values towards the two or more target values according to the third aggressiveness profile.

13. The method of claim 12 , wherein the third titration aggressiveness profile corresponds to a least aggressive titration, the less aggressive titration of the second titration aggressiveness profile defined by at least one of the following as compared to the least aggressive titration of the third titration aggressiveness profile:

a shorter time interval for a transition from the first set of parameters to the target value,

one or more greater target values, or

greater increment values between the first value and the target value.

14. The method of claim 11 , wherein modifying the neurostimulation signal occurs after receiving the feedback signal a plurality of times.

15. The method of claim 11 , wherein receiving the feedback signal comprises detecting the feedback signal using a magnet detection circuit configured to detect a presence of a magnet in proximity of the implantable pulse generator.

16. The method of claim 11 , wherein increasing the two or more of output current, frequency, pulse width, or duty cycle from the two or more second values comprises increasing the two or more of output current, frequency, pulse width, or duty cycle from the two or more second values towards the two or more target values at a first rate; and

wherein the method further comprises subsequently increasing the two or more of output current, frequency, pulse width, or duty cycle from the two or more intermediate target values towards the two or more target values at a second rate.

17. The method of claim 16 , wherein the second rate is lower than the first rate.

18. A non-transitory computer-readable medium storing instructions executable by a processor to:

receive a plurality of titration aggressiveness profiles from an external programmer, each titration aggressiveness profile of the plurality of titration aggressiveness profiles having a rate of titration and a range of values for each of a plurality of parameters, the plurality of titration aggressiveness profiles including at least a first titration aggressiveness profile and a second titration aggressiveness profile;

deliver a neurostimulation signal at a first location on first titration aggressiveness profile, the first location being a first set of parameters having two or more first values for two or more of output current, frequency, pulse width, or duty cycle of the neurostimulation signal;

increase the two or more of output current, frequency, pulse width, or duty cycle from the two or more first values towards two or more target values according to the first aggressiveness profile;

receive a feedback signal from the patient indicating an adverse effect from the neurostimulation signal at an intermediate location on the first aggressiveness profile, the intermediate location being an intermediate set of parameters having two or more intermediate values for the two or more of output current, frequency, pulse width, or duty cycle of the neurostimulation signal, wherein the two or more intermediate values are between the two or more first values and the two or more target values; and

in response to the feedback signal:

identify a second location on the second titration aggressiveness profile, the second location being a second set of parameters having two or more second values for the two or more of output current, frequency, pulse width, or duty cycle that are less than or equal to the two or more intermediate values;

deliver the neurostimulation signal at the second location on the second titration aggressiveness profile; and

increase the two or more of output current, frequency, pulse width, or duty cycle from the two or more second values towards the two or more target values according to the second aggressiveness profile;

wherein the second titration aggressiveness profile corresponds to a less aggressive titration and the first titration aggressiveness profile corresponds to a more aggressive titration, the more aggressive titration defined by at least one of the following as compared to the less aggressive titration:

a shorter time interval for a transition from the first set of parameters to the two or more target values,

one or more greater target values, or

greater increment values between the two or more first values and the two or more target values.

19. The non-transitory computer-readable medium of claim 18 , wherein the plurality of titration aggressiveness profiles further includes a third titration aggressiveness profile and the instructions are further executable to:

receive the third titration aggressiveness profile from the external programmer;

receive a second feedback signal from the patient indicating an adverse effect from the neurostimulation signal at a second intermediate location on the second aggressiveness profile, the second intermediate location being a second intermediate set of parameters having two or more second intermediate values for the two or more of output current, frequency, pulse width, or duty cycle of the neurostimulation signal, the two or more second intermediate values being between the two or more intermediate values and the two or more target values;

identify a third location on a third titration aggressiveness profile, the third location being a third set of parameters having two or more third values for the two or more of output current, frequency, pulse width, or duty cycle that are less than or equal to the two or more second intermediate values;

deliver the neurostimulation signal at the third location on the third titration aggressiveness profile; and

increase the at least two of output current, frequency, pulse width, or duty cycle from the two or more third values towards the two or more target values according to the third aggressiveness profile.

20. The non-transitory computer-readable medium of claim 18 , wherein the instructions are executable to modify the neurostimulation signal after receiving the feedback signal a plurality of times.

Assignments (6)
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 Oct 21, 2020
From: STUBBS, SCOTT; LIBBUS, IMAD; MAZAR, SCOTT; KENKNIGHT, BRUCE H.; AMURTHUR, BADRI
To: LIVANOVA USA, INC.
Reel/Frame 054128/0152 →
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 PCTUS2018050930 · Sep 13, 2018
Provisional Application 62558817 · Sep 14, 2017
Related Publication 20200108255A1 · Apr 9, 2020
Cited By (1)
US 12,485,284