Method and apparatus for clinical effects-based targeting of neurostimulation

Patent metadata

Field	Value
Publication number	US-11517755-B2
Application number	US-202017137907-A
Country	US
Kind code	B2
Filing date	Dec 30, 2020
Priority date	Mar 27, 2017
Publication date	Dec 6, 2022
Grant date	Dec 6, 2022

Abstract

An example of a system for delivering neurostimulation may include a programming control circuit and a stimulation control circuit. The programming control circuit may be configured to generate stimulation parameters controlling delivery of the neurostimulation according to a stimulation configuration. The stimulation control circuit may be configured to specify the stimulation configuration, and may include volume definition circuitry and stimulation configuration circuitry. The volume definition circuitry may be configured to determine one or more test volumes, determine a clinical effect resulting from the one or more test volumes each being activated by the neurostimulation, and determine a target volume using the determined clinical effect. The stimulation configuration circuitry may be configured to generate the specified stimulation configuration for activating the target volume.

First claim

What is claimed is:

1. A method for controlling delivery of neurostimulation to tissue of a patient from a stimulation device using a programming device, the method comprising:
determining one or more volumes of activation;
determining clinical effects each resulting from one of the determined one or more volumes of activation being activated by the neurostimulation;
generating a recommendation for a direction for determining a target volume based on the determined one or more volumes of activation, the determined one or more clinical effects, and weights each applied to one of the clinical effects using a processor of the programming device;
determining the target volume using the recommendation; and
generating a plurality of stimulation parameters for controlling delivery of the neurostimulation to activate a stimulation volume substantially matching the target volume using the processor,
wherein the one or more volumes of activation, the target volume, and the stimulation volume each represent a portion of the tissue.

2. The method of claim 1 , wherein determining the clinical effects comprises determining one or more therapeutic benefits and one or more side effects.

3. The method of claim 2 , further comprising presenting the clinical effects in a form of menus of symptoms with weighting options.

4. The method of claim 3 , wherein generating the recommendation comprises generating a recommended volume representing a portion of the tissue, and further comprising allowing the user to set the target volume to the recommended volume.

5. The method of claim 3 , further comprising allowing the user to set the target volume to one of the one or more volumes of activation.

6. The method of claim 3 , further comprising allowing a user to mark a volume of the one or more volumes of activation as a mark volume to allow for tracking of attempts of determining the target volume, and wherein determining the target volume further comprises allowing the user to set the target volume to the mark volume.

7. The method of claim 2 , wherein determining the clinical effects comprises determining a therapeutic benefit score and a side effect score for each of the one or more volumes of activation, the therapeutic benefit score representative of a degree of the one or more therapeutic benefits, the side effect score representative of a degree of the one or more side effects.

8. The method of claim 7 , wherein determining the clinical effects comprises determining a therapeutic benefits contour and a side effect contour for each of the one or more volumes of activation, the therapeutic benefits contour indicative of a volume of the tissue excitable for one or more desirable therapeutic benefits, the side effect contour indicative of a volume of the tissue excitable for one or more unwanted side effects.

9. The method of claim 1 , wherein determining the clinical effects comprises sensing one or more of signals from the patient.

10. The method of claim 1 , wherein determining the clinical effects comprises receiving information entered by at least one of the patient or the user.

11. A system for delivering neurostimulation to tissue of a patient and controlling the delivery of the neurostimulation by a user, the system comprising:
a stimulation control circuit configured to:
determine one or more volumes of activation;
determine clinical effects each resulting from one of the determined one or more volumes of activation being activated by the neurostimulation;
generate a recommendation for a direction for determining a target volume based on the determined one or more volumes of activation, the determined clinical effects, and weights each applied to one of the clinical effects; and
determine a target volume using the recommendation; and

a programming control circuit configured to generate a plurality of stimulation parameters controlling delivery of the neurostimulation to activate a stimulation volume substantially matching the target volume,
wherein the one or more volumes of activation, the target volume, and the stimulation volume each represent a portion of the tissue.

12. The system of claim 11 , wherein the stimulation control circuit is configured to determine one or more therapeutic benefits and one or more side effects of the clinical effects.

13. The system of claim 12 , further comprising a user interface, and wherein the stimulation control circuit is configured to present the clinical effects as symptoms on the user interface.

14. The system of claim 11 , wherein the one or more volumes of activation comprise a plurality of volumes of activation, and the stimulation control circuit is further configured to determine the plurality of volumes of activation and to determine clinical effect information sets each representing the clinical effect resulting from activation of a volume of the determined plurality of volumes of activation by the neurostimulation.

15. The system of claim 14 , wherein the stimulation control circuit is further configured to allow the user to mark a volume of the determined plurality of volumes of activation as a mark volume to allow for tracking of attempts of determining the target volume.

16. The system of claim 15 , wherein the stimulation control circuit is further configured to allow the user to set the target volume to the mark volume, the recommended volume, or a volume of the plurality of volumes of activation.

17. The system of claim 1 , wherein the stimulation control circuit is configured to determine a therapeutic benefit score and a side effect score for each of the one or more volumes of activation, the therapeutic benefit score representative of a degree of the one or more therapeutic benefits, the side effect score representative of a degree of the one or more side effects.

18. The system of claim 17 , wherein the stimulation control circuit is configured to present a therapeutic benefits contour and a side effect contour for each of the one or more volumes of activation, the therapeutic benefits contour indicative of a volume of the tissue excitable for one or more desirable therapeutic benefits, the side effect contour indicative of a volume of the tissue excitable for one or more unwanted side effects.

19. A non-transitory computer-readable storage medium including instructions, which when executed by a system, cause the system to perform a method for controlling delivery of neurostimulation to tissue of a patient using a plurality of electrodes, the method comprising:
determining one or more volumes of activation;
determining clinical effects each resulting from one of the determined one or more volumes of activation being activated by the neurostimulation;
generating a recommendation for a direction for determining a target volume based on the determined one or more volumes of activation, the determined one or more clinical effects, and weights each applied to one of the clinical effects;
determining the target volume using the recommendation; and
generating a plurality of stimulation parameters for controlling delivery of the neurostimulation to activate a stimulation volume substantially matching the target volume,
wherein the one or more volumes of activation, the target volume, and the stimulation volume each represent a portion of the tissue.

20. The non-transitory computer-readable storage medium of claim 19 , wherein determining the clinical effects comprises determining one or more therapeutic benefits and one or more side effects, and wherein the method fur

Assignees

• Boston Scient Neuromodulation Corp

Inventors

• Zhang Tianhe
• Moffitt Michael A
• Mustakos Richard
• Carcieri Stephen

Classifications

• A61N1/36132

  using patient feedback · CPC title

• A61B5/24

  Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof · CPC title

• A61N1/36128

  Control systems · CPC title

• A61N1/36146

  specified by the stimulation parameters · CPC title

• A61B5/6868

  Brain · CPC title