Neurostimulation titration process via adaptive parametric modification

Patent metadata

Field	Value
Publication number	US-12285615-B2
Application number	US-202318541938-A
Country	US
Kind code	B2
Filing date	Dec 15, 2023
Priority date	Nov 12, 2014
Publication date	Apr 29, 2025
Grant date	Apr 29, 2025

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.

First claim

What is claimed is:

1. A method of operating an implantable medical device (IMD) comprising:
delivering neurostimulation to a patient by the IMD, the neurostimulation comprising a plurality of stimulation parameters;
titrating the neurostimulation from an initial intensity toward a target intensity by modifying at least one of the stimulation parameters;
receiving an indication of intolerance to the neurostimulation;
in response to receiving the indication, modifying a first stimulation parameter to decrease an intensity of the neurostimulation;
determining that the first stimulation parameter has reached a maximum modification; and
in response to determining that the first stimulation parameter has reached the maximum modification, modifying a second stimulation parameter to decrease the intensity of the neurostimulation, the second stimulation parameter being different than the first stimulation parameter.

2. The method of claim 1 , wherein the stimulation parameters comprise current amplitude, pulse width, frequency, and duty cycle.

3. The method of claim 2 , wherein modifying the first stimulation parameter or the second stimulation parameter comprises decreasing at least one of the current amplitude or the pulse width.

4. The method of claim 1 , further comprising:
in response to receiving a plurality of additional indications of intolerance, modifying a third stimulation parameter to decrease the intensity of the neurostimulation, the third stimulation parameter being different from at least one of the first stimulation parameter or the second stimulation parameter.

5. The method of claim 1 , further comprising receiving, from an external programmer, a prescribed time window during which the intensity of the neurostimulation is increased, the prescribed time window excluding a period during which the patient is likely sleeping.

6. The method of claim 1 , wherein the indication of intolerance is received from the patient via a patient magnet.

7. The method of claim 1 , further comprising modifying an increment at which the neurostimulation is titrated based on a response of the patient to the neurostimulation.

8. A medical device for delivering neurostimulation comprising:
an implantable neurostimulator configured to:
deliver neurostimulation to a patient, the neurostimulation comprising a plurality of stimulation parameters;
titrate the neurostimulation from an initial intensity toward a target intensity by modifying at least one of the stimulation parameters;
receive an indication of intolerance to the neurostimulation;
in response to receiving the indication, modifying a first stimulation parameter to decrease an intensity of the neurostimulation;
determine that the first stimulation parameter has reached a maximum modification; and
in response to determining that the first stimulation parameter has reached the maximum modification, modify a second stimulation parameter to decrease the intensity of the neurostimulation, the second stimulation parameter being different than the first stimulation parameter.

9. The medical device of claim 8 , wherein the stimulation parameters comprise current amplitude, pulse width, frequency, and duty cycle.

10. The medical device of claim 9 , wherein the implantable neurostimulator is further configured to modify the first stimulation parameter or the second stimulation parameter by decreasing at least one of the current amplitude or the pulse width.

11. The medical device of claim 8 , wherein the implantable neurostimulator is further configured to, in response to receiving a plurality of additional indications of intolerance, modify a third stimulation parameter to decrease the intensity of the neurostimulation, the third stimulation parameter being different from at least one of the first stimulation parameter or the second stimulation parameter.

12. The medical device of claim 8 , wherein the implantable neurostimulator is further configured to receive, from an external programmer, a prescribed time window during which the intensity of the neurostimulation is increased, the prescribed time window excluding a period during which the patient is likely sleeping.

13. The medical device of claim 8 , wherein the indication of intolerance is received from the patient via a patient magnet.

14. The medical device of claim 8 , wherein the implantable neurostimulator is further configured to modify an increment at which the neurostimulation is titrated based on a response of the patient to the neurostimulation.

15. A system comprising:
a processor; and
a memory storing instructions that are executable by the processor to:
deliver neurostimulation to a patient, the neurostimulation comprising a plurality of stimulation parameters;
titrate the neurostimulation from an initial intensity toward a target intensity by modifying at least one of the stimulation parameters;
receive an indication of intolerance to the neurostimulation;
in response to receiving the indication, modify a first stimulation parameter to decrease an intensity of the neurostimulation;
determine that the first stimulation parameter has reached a maximum modification; and
in response to determining that the first stimulation parameter has reached the maximum modification, modify a second stimulation parameter to decrease the intensity of the neurostimulation, the second stimulation parameter being different than the first stimulation parameter.

16. The system of claim 15 , wherein the stimulation parameters comprise current amplitude, pulse width, frequency, and duty cycle.

17. The system of claim 16 , wherein the instructions are further executable by the processor to modify the first stimulation parameter or the second stimulation parameter by decreasing at least one of the current amplitude or the pulse width.

18. The system of claim 15 , wherein the instructions are further executable by the processor to, in response to receiving a plurality of additional indications of intolerance, modify a third stimulation parameter to decrease the intensity of the neurostimulation, the third stimulation parameter being different from at least one of the first stimulation parameter or the second stimulation parameter.

19. The system of claim 15 , wherein the instructions are further executable by the processor to receive, from an external programmer, a prescribed time window during which the intensity of the neurostimulation is increased, the prescribed time window excluding a period during which the patient is likely sleeping.

20. The system of claim 15 , wherein the instructions are further executable by the processor to modify an increment at which the neurostimulation is titrated based on a response of the patient to the neurostimulation.

Assignees

• Livanova Usa Inc

Inventors

• Libbus Imad
• Kenknight Bruce H
• Amurthur Badri
• Stubbs Scott R

Classifications

• G16H20/40

  relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture · CPC title

• A61N1/37235

  Aspects of the external programmer · CPC title

• A61N1/37223

  Circuits for electromagnetic coupling · CPC title

• A61N1/36167

  Timing, e.g. stimulation onset · CPC title

• A61N1/3615

  Intensity · CPC title