EP-4736175-A1 - NEUROSTIMULATION CLOSED-LOOP PROGRAMMING RECOMMENDATION SYSTEM

Abstract

Systems aanndd mmeetthhooddss ffoorr generating and implementing customized recommendations as part of closed-loop neurostimulation programming and device configuration approaches are disclosed. In an example, a system is configured to: identify, with a recommendation model (e.g., a closed-loop programming algorithm), a programming setting for use in a neurostimulation device that controls neurostimulation treatment of a patient; communicate, to a patient device (e.g., a patient smartphone), a command to present a recommendation to use the programming setting; and communicate, to the patient device, data values associated with the programming setting, to reconfigure the neurostimulation device according to the programming setting. In various examples, a medical user interface enables a medical user (e.g., clinician) to customize the recommendation, and a patient user interface enables a patient to view and use the recommendation.

Inventors

• MCDONALD, MATTHEW LEE
• HERSHEY, BRADLEY LAWRENCE
• BAINS, Amarpreet Singh
• HUYNH, Dat Thanh
• HARVEY, MARCUS

Assignees

• Boston Scientific Neuromodulation Corporation

Dates

Publication Date

20260506

Application Date

20240625

Claims (15)

1. 1. A system to generate recommendations for neurostimulation device configuration, the system comprising: one or more processors; and one or more memory devices comprising instructions, which when executed by the one or more processors, cause the one or more processors to: identify, with a recommendation model, a programming setting for use a neurostimulation device to control neurostimulation treatment of a patient; communicate, to a patient device, a command to present a recommendation to use the programming setting, wherein the recommendation is customized by another user, and wherein the patient device includes a patient user interface to present the recommendation to the patient; and communicate, to the patient device, data values associated with the programming setting, wherein the data values are used to reconfigure the neurostimulation device according to the programming setting.
2. 2. The system of claim 1, wherein the another user is a medical user associated with care of the patient, and wherein the instructions further cause the one or more processors to: communicate, to a medical user device, the programming setting identified with the recommendation model; and receive, from the medical user device, a command to activate the recommendation for use of the programming setting, wherein the medical user device includes a medical user interface to enable the medical user to customize and activate the recommendation; wherein operations to communicate the command and the data values to the patient device occur after customization and activation of the recommendation by the medical user.
3. 3. The system of claim 2, wherein the medical user interface presents the recommendation in a prioritized listing of multiple available recommendations for the patient, and wherein the medical user interface receives user input from the medical user to provide the customization and the activation of the recommendation.
4. 4. The system of claim 2, wherein the medical user interface receives user input from the medical user to modify at least a part of the programming setting or modify at least one presentation characteristic of the recommendation.
5. 5. The system of claim 1, wherein the patient user interface further includes encoded data values associated with the programming setting, and wherein the encoded data values are readable by a patient programming device to cause the patient programming device to reconfigure operation of the neurostimulation device according to the programming setting.
6. 6. The system of claim 1, wherein the patient device includes programming functionality to directly communicate the programming setting to the neurostimulation device.
7. 7. The system of any of claims 1 to 6, wherein the patient device is a smartphone operable by the patient, and wherein the patient user interface is presented in a software app installed on the smartphone.
8. 8. The system of any of claims 1 to 7, wherein the recommendation to use the programming setting is associated with a recommended time of delivery or validity for the patient device.
9. 9. The system of any of claims 1 to 8, wherein the instructions further cause the one or more processors to: receive, from the patient device, feedback relating to the recommendation, wherein subsequent recommendations to reconfigure the neurostimulation device are customized to the patient based on the feedback.
10. 10. The system of claim 9, wherein the recommendation model is further configured to evaluate data values based on the feedback relating to the recommendation, wherein the feedback relates to one or more of: sleep, pain, movement, emotional state, medication state, mobility, or activity, in connection with use of the neurostimulation treatment, and wherein the feedback is obtained from the patient using one or more questionnaires, surveys, freeform text inputs, voice inputs, or sensor data observations.
11. 11. The system of any of claims 1 to 10, wherein the recommendation model is further configured to evaluate device data collected during use of a program to perform the neurostimulation treatment.
12. 12. The system of any of claims 1 to 11, wherein the patient device is further configured to receive a user command to manually input or control the data values, to reconfigure a program in the neurostimulation device according to the programming setting.
13. 13. The system of any of claims 1 to 12, wherein the data values to reconfigure the neurostimulation device causes a change to one or more of: timing, amplitude, frequency, intensity, duration, pulse patterns, pulse shapes, a spatial location of pulses, waveform shapes, or a spatial location of waveform shapes, of modulated energy provided with a plurality of leads of the neurostimulation device.
14. 14. A machine-readable medium including instructions, which when executed by a machine, cause the machine to perform the operations of the system of any of the claims 1 to 13.
15. 15. A method to perform the operations of the system of any of the claims 1 to 13.

Description

NEUROSTIMULATION CLOSED-LOOP PROGRAMMING RECOMMENDATION SYSTEM CLAIM OF PRIORITY [0001] This application claims the benefit of U.S. Provisional Application No. 63/523,539 filed on June 27, 2023, which is hereby incorporated by reference in its entirety. TECHNICAL FIELD [0002] This document relates generally to data processing obtained in connection with the use of medical devices, and more particularly, to systems, devices, and methods for generating and presenting recommendations in connection with implanted electrical stimulation, including human-guided programming recommendations for neurostimulation treatments used for pain treatment, movement disorders, and/or management of such conditions. BACKGROUND [0003] Neurostimulation, also referred to as neuromodulation, has been proposed as a therapy for a number of conditions. Examples of neurostimulation include Spinal Cord Stimulation (SCS), Deep Brain Stimulation (DBS), Peripheral Nerve Stimulation (PNS), and Functional Electrical Stimulation (FES). A neurostimulation system can be used to electrically stimulate tissue or nerve centers to treat nervous or muscular disorders. For example, an SCS system may be configured to deliver electrical pulses to a specified region of a patient’s spinal cord, such as particular spinal nerve roots or nerve bundles, to produce an analgesic effect that masks pain sensation, or to produce a functional effect that allows increased movement or activity of the patient. Other forms of neurostimulation may include a DBS system which uses similar pulses of electricity at particular locations in the brain to reduce symptoms of essential tremors, Parkinson’s disease, psychological disorders, or the like. [0004] Various approaches are being developed to enable personalized programming and optimized forms of programming used by neurostimulation systems, including partially or fully automated forms of generating or delivering specific neurostimulation parameters known as closed-loop programming. Some closed-loop programming approaches can, for example, customize changes to stimulator programs, or may suggest or automatically select a program when a particular condition is identified. However, due to changing patient needs and the many types of changes that can be implemented in neurostimulation systems, some patients (or clinicians/medical professionals who supervise such patients) may not be able to use closed-loop programming for their neurostimulation systems. SUMMARY [0005] Example l is a system to generate recommendations for neurostimulation device configuration, the system comprising: one or more processors; and one or more memory devices comprising instructions, which when executed by the one or more processors, cause the one or more processors to: identify, with a recommendation model, a programming setting for use a neurostimulation device to control neurostimulation treatment of a patient; communicate, to a patient device, a command to present a recommendation to use the programming setting, wherein the recommendation is customized by another user, and wherein the patient device includes a patient user interface to present the recommendation to the patient; and communicate, to the patient device, data values associated with the programming setting, wherein the data values are used to reconfigure the neurostimulation device according to the programming setting. [0006] In Example 2, the subject matter of Example 1 optionally includes subject matter where the another user is a medical user associated with care of the patient, and wherein the instructions further cause the one or more processors to: communicate, to a medical user device, the programming setting identified with the recommendation model; and receive, from the medical user device, a command to activate the recommendation for use of the programming setting, wherein the medical user device includes a medical user interface to enable the medical user to customize and activate the recommendation; wherein operations to communicate the command and the data values to the patient device occur after customization and activation of the recommendation by the medical user. [0007] In Example 3, the subject matter of Example 2 optionally includes subject matter where the medical user interface presents the recommendation in a prioritized listing of multiple available recommendations for the patient, and wherein the medical user interface receives user input from the medical user to provide the customization and the activation of the recommendation. [0008] In Example 4, the subject matter of any one or more of Examples 2-3 optionally include subject matter where the medical user interface receives user input from the medical user to modify at least a part of the programming setting or modify at least one presentation characteristic of the recommendation. [0009] In Example 5, the subject matter of any one or more of Examples 1-4 optionally include subject matter where the pa