Neurostimulation titration process via adaptive parametric modification

• US 9,504,832 B2
• Filed: 12/08/2014
• Issued: 11/29/2016
• Est. Priority Date: 11/12/2014
• Status: Active Grant

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Libbus, Imad, KenKnight, Bruce H., Amurthur, Badri, Stubbs, Scott R.
• Primary Examiner(s): PATTON, AMANDA K
• Application Number:
  US14/563,181
• Publication Number:
  US 20160129259A1
• Time in Patent Office: 722 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/355 Detecting T-waves
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36132 using patient feedback
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/3615 Intensity
• CPC Class Codes: A61N 1/36167 Timing, e.g. stimulation onset
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371
• CPC Class Codes: A61N 1/37223 Circuits for electromagnetic coupling
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• CPC Class Codes: G16H 20/30 relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/20 for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

Systems and methods are provided for delivering neurostimulation therapies to patients. A titration process is used to gradually increase the stimulation intensity to a desired therapeutic level. Between titration sessions one or more parameters, such as, for example, an acclimation interval, may be adjusted based on the patient'"'"'s response to the stimulation. This personalized 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

1. A method of operating an implantable medical device (IMD) comprising a neurostimulator coupled to an electrode assembly, said method comprising:

initiating a plurality of titration sessions, each titration session separated from an adjacent titration session by an acclimation interval, wherein the titration sessions comprise activating the IMD to deliver a stimulation signal of gradually increasing intensity until the patient exceeds a side effect tolerance zone boundary;

analyzing an outcome measure of the plurality of titration sessions, wherein the outcome measure comprises a target increase in stimulation intensity or a target increase in output current; and

modifying one or more stimulation parameters based on the analyzed outcome measure.

2. The method according to claim 1, wherein:

the modifying one or more stimulation parameters comprises modifying an increment for gradually increasing one or more stimulation parameters in order to increase stimulation intensity during a subsequent titration session.

3. The method according to claim 1, wherein:

the modifying the one or more stimulation parameters comprises modifying the increment for gradually increasing one or more of the following;

current amplitude, pulse width, frequency, and OFF time.

4. The method according to claim 1, wherein:

the modifying one or more stimulation parameters comprises modifying the acclimation interval until a subsequent titration session based on the analyzed outcome measure.

5. The method according to claim 4, wherein:

said modifying the acclimation interval comprises increasing the acclimation interval in response to an outcome measure indicating slower than expected patient adaptation.

6. The method according to claim 4, wherein:

the outcome measure comprises the target increase in stimulation intensity; and

said modifying the acclimation interval comprises increasing the acclimation interval in response to a failure to achieve the target increase in stimulation intensity.

7. The method according to claim 4, wherein:

the stimulation signal comprises an output current, a frequency, a pulse width, and a duty cycle;

the outcome measure comprises the target increase in output current; and

said modifying the acclimation interval comprises increasing the acclimation interval in response to a failure to achieve the target increase in output current over the plurality of titration sessions.

8. The method according to claim 4, wherein:

said modifying the acclimation interval comprises decreasing the acclimation interval before the subsequent titration session in response to an outcome measure indicating faster than expected patient adaptation.

9. The method according to claim 4, further comprising:

during the acclimation intervals, activating the IMD to deliver a stimulation signal at an intensity resulting in an acceptable side effect level.

10. The method according to claim 1, further comprising:

determining a maintenance dosage level corresponding to a tolerable stimulation intensity achieving adequate adaptation; and

delivering stimulation at the maintenance dosage level.

11. A method according to claim 10, wherein adequate adaptation comprises one or more of:

an acceptable side effect level, a target physiological response, and a target stimulation parameter set.

12. The method according to claim 1, further comprising:

receiving a patient input indicating the side effect tolerance zone boundary.

13. The method according to claim 12, wherein:

said receiving the patient input comprises receiving a radio frequency (RF) signal from an external communications device, said wireless signal indicating that the patient has reached the side effect tolerance zone boundary.

14. The method according to claim 12, wherein:

said receiving the patient input comprises detecting a magnetic field indicating that the patient has reached the side effect tolerance zone boundary.

15. The method according to claim 12, wherein:

said receiving the patient input comprises detecting an acoustic signal indicating that the patient has reached the side effect tolerance zone boundary.

16. The method according to claim 12, wherein:

said receiving the patient input comprises detecting a motion signal with a motion sensor indicating that the patient has reached the side effect tolerance zone boundary.

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

initiating an elevated stimulation session at an elevated stimulation intensity for a first period of time; and

after the first period of time, initiating sustained stimulation at a sustained stimulation intensity for a second period of time, wherein the elevated stimulation intensity is greater than the sustained stimulation intensity.

18. The method according to claim 17, wherein:

the elevated stimulation intensity corresponds to a moderate side effect tolerance zone; and

the sustained stimulation intensity produces tolerable side effects.

19. The method according to claim 17, wherein:

the first period of time is less than one day; and

the second period of time is greater than one day.

20. The method according to claim 19, wherein:

the first period of time is less than six hours; and

the second period of time is greater than one week.

21. The method according to claim 1, further comprising:

receiving a session initiation input to indicating an initiation time for titration sessions.

22. The method according to claim 21, wherein:

the session initiation input indicates a time of day during which titration sessions are to be initiated.

23. The method according to claim 21, wherein:

the receiving the session initiation input comprises receiving a radio frequency (RF) signal from an external communications device.

24. The method according to claim 21, wherein:

the receiving the session initiation input comprises detecting a magnetic field.

25. The method according to claim 1, further comprising:

in response to receiving a command from an external clinician programmer, initiating a training session comprising activating the IMD to deliver a stimulation signal of gradually increasing intensity; and

receiving a control input from a patient device indicating the side effect tolerance zone boundary.

26. The method according to claim 25, wherein:

said receiving the control input from the patient device comprises receiving a radio frequency (RF) signal from an external patient device, said wireless signal indicating that the patient has reached the side effect tolerance zone boundary.

27. The method according to claim 25, wherein:

said receiving the control input from the patient device comprises detecting a magnetic field indicating that the patient has reached the side effect tolerance zone boundary.

28. The method according to claim 25, further comprising:

transmitting from the IMD to the external clinician programmer information regarding the stimulation signal intensity.

29. The method according to claim 25, further comprising:

in response to receiving a hold command from the external clinician programmer, temporarily ceasing the gradual increase of intensity of the stimulation signal.

30. The method according to claim 25, further comprising:

displaying on a user interface of the external clinician programmer instructions for conducting the training session.

31. The method according to claim 25, further comprising:

in response to receiving a command from an external clinician programmer, initiating a training session comprising activating the IMD to deliver a stimulation signal of gradually increasing intensity; and

receiving a control input to proceed to a subsequent step in the training session.

32. A method of operating an implantable medical device (IMD) comprising a neurostimulator coupled to an electrode assembly, said method comprising:

initiating a plurality of titration sessions, each titration session separated from an adjacent titration session by an acclimation interval, wherein the titration sessions comprise activating the IMD to deliver a stimulation signal of gradually increasing intensity until the patient exceeds a side effect tolerance zone boundary;

analyzing an outcome measure of the plurality of titration sessions; and

modifying the acclimation interval based on the analyzed outcome measure, the modifying the acclimation interval comprising one or more of;

increasing the acclimation interval in response to an outcome measure indicating slower than expected patient adaptation;

or

decreasing the acclimation interval before the subsequent titration session in response to an outcome measure indicating faster than expected patient adaptation.

33. A method of operating an implantable medical device (IMD) comprising a neurostimulator coupled to an electrode assembly, said method comprising:

initiating a plurality of titration sessions, each titration session separated from an adjacent titration session by an acclimation interval, wherein the titration sessions comprise activating the IMD to deliver a stimulation signal of gradually increasing intensity until the patient exceeds a side effect tolerance zone boundary;

analyzing an outcome measure of the plurality of titration sessions;

modifying one or more stimulation parameters based on the analyzed outcome measure;

initiating an elevated stimulation session at an elevated stimulation intensity for a first period of time, the elevated stimulation intensity corresponding to a moderate side effect tolerance zone; and

after the first period of time, initiating sustained stimulation at a sustained stimulation intensity for a second period of time, wherein the elevated stimulation intensity produces tolerable side effects and is greater than the sustained stimulation intensity.