IP Library Granted Patent US 9,533,153
Granted Patent B2
US 9,533,153 · App. 14/457,807 · Granted Jan 3, 2017

Neurostimulation titration process

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Quick Facts
Patent No.
US 9,533,153
App. No.
14/457,807
Granted
Jan 3, 2017
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 (33)

1. A method of operating an implantable medical device (IMD) comprising a neurostimulator coupled to an electrode assembly, said neurostimulator having a stimulation parameter set comprising an output current, a frequency, a pulse width, and a duty cycle, said method comprising:

at an initial titration session, activating the IMD to generate a stimulation signal having an initial stimulation parameter set, said initial parameter set comprising an initial output current, an initial frequency, an initial pulse width, and an initial duty cycle; and

performing a titration process, said titration process comprising:

increasing the output current of the stimulation signal until the stimulation signal comprises a target output current or adequate adaption is achieved; and

after the stimulation signal comprises the target output current, increasing one or more of the frequency, pulse width, and duty cycle, wherein said increasing the frequency, pulse width, and duty cycle comprises increasing the frequency, pulse width, and duty cycle until a composite threshold is reached, wherein said composite threshold is reached when the stimulation signal comprises a target parameter set or the patient exceeds a side effect tolerance zone boundary, wherein the target parameter set comprises a target duty cycle of between about 15% to about 30%.

2. A method according to claim 1 , wherein adequate adaptation comprises one or more of: an acceptable side effect level, a target physiological response, and a target stimulation parameter set.

3. A method according to claim 2 , wherein said target physiological response comprises a target heart rate change.

4. A method according to claim 1 , wherein the target parameter set comprises a target frequency of between 8 Hz and 12 Hz.

5. A method according to claim 1 , wherein the target parameter set comprises a target frequency of about 10 Hz.

6. A method according to claim 1 , wherein the target parameter set comprises a target pulse width of about 250 μsec.

7. A method according to claim 1 , wherein the target parameter set comprises a target duty cycle of about 17.5%.

8. A method according claim 1 , wherein the target parameter set comprises a target duty cycle of about 14 seconds of pulse ON time and 66 seconds of pulse OFF time.

9. A method according to claim 1 , wherein the titration process further comprises:

after increasing the output current of the stimulation signal, when the patient exceeds a side effect tolerance zone boundary before stimulation signal comprises the target output current, decreasing the frequency and subsequently increasing the output current until either stimulation signal comprises the target output current or the patient again exceeds the side effect tolerance zone boundary.

10. A method according to claim 9 , wherein said decreasing the frequency and subsequently increasing the output current comprises decreasing the frequency to about 5 Hz or less.

11. A method according to claim 9 , wherein the titration process further comprises:

after decreasing the frequency to a lowered frequency level and subsequently increasing the output current, when the patient again exceeds the side effect tolerance zone boundary before the stimulation signal comprises the target output current while at the lowered frequency level, increasing the frequency to an elevated frequency level and subsequently increasing the duty cycle until either the stimulation signal comprises a target duty cycle or the patient subsequently exceeds the side effect tolerance zone boundary.

12. A method according to claim 11 , wherein:

when the target duty cycle is reached, increasing the pulse width until the stimulation signal comprises a target pulse width and increasing the frequency until the stimulation signal comprises the target frequency.

13. A method according to claim 1 , wherein the titration process further comprises:

after increasing the output current of the stimulation signal, when the patient exceeds a side effect tolerance zone boundary before stimulation signal comprises the target output current, decreasing the pulse width and subsequently increasing the output current until either stimulation signal comprises the target output current or the patient again exceeds the side effect tolerance zone boundary.

14. A method according to claim 13 , wherein said decreasing the pulse width and subsequently increasing the output current comprises decreasing the pulse width to about 150 μsec or less.

15. A method according to claim 1 , further comprising:

at a subsequent titration session occurring after a period of time has elapsed since a previous titration session, performing the titration process.

16. A method according to claim 15 , wherein said period of time comprises at least one day, one week, or one month.

17. A method according to claim 1 , further comprising:

receiving a wireless signal from an external communications device, said wireless signal indicating that the patient has reached the side effect tolerance zone boundary.

18. A method of operating an implantable medical device (IMD) comprising a neurostimulator coupled to an electrode assembly, said neurostimulator having a stimulation parameter set comprising an output current, a frequency, a pulse width, and a duty cycle, said method comprising:

at an initial titration session, activating the IMD to generate a stimulation signal having an initial stimulation parameter set, said initial parameter set comprising an initial output current, an initial frequency, an initial pulse width, and an initial duty cycle; and

performing a titration process, said titration process comprising:

increasing the output current of the stimulation signal until the stimulation signal comprises a target output current or adequate adaptation is achieved;

after increasing the output current of the stimulation signal, when the patient exceeds a side effect tolerance zone boundary before stimulation signal comprises the target output current, decreasing the frequency and subsequently increasing the output current until either stimulation signal comprises the target output current or the patient again exceeds the side effect tolerance zone boundary; and

after the stimulation signal comprises the target output current, increasing one or more of the frequency, pulse width, and duty cycle.

Assignments (7)
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 →
CHANGE OF NAME Recorded Jun 29, 2020
From: CYBERONICS, INC.
To: LIVANOVA USA, INC.
Reel/Frame 053306/0229 →
PATENT SECURITY AGREEMENT Recorded Jun 17, 2020
From: LIVANOVA USA, INC.
To: ARES CAPITAL CORPORATION, AS COLLATERAL AGENT
Reel/Frame 053673/0675 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 23, 2014
From: LIBBUS, IMAD; KENKNIGHT, BRUCE H.; AMURTHUR, BADRI
To: CYBERONICS, INC.
Reel/Frame 033795/0751 →