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EP-4739381-A1 - PATIENT FEEDBACK SYSTEM FOR ADJUSTING STIMULATION PARAMETERS

EP4739381A1EP 4739381 A1EP4739381 A1EP 4739381A1EP-4739381-A1

Abstract

A system may include a stimulator configured to deliver a DBS therapy according to a first therapy program, and a processing system. The processing system may be configured for use to receive a logged event indicative of an acute reduction in therapy, automatically identify a second therapy program for the DBS therapy to address the acute reduction in therapy, deliver the DBS therapy according to the second therapy program, prompt the user to report whether the user likes or dislikes the DBS therapy delivered according to the second therapy program, and control the DBS therapy based on the report by choosing a third therapy program, reverting to the first therapy program, or continuing to deliver the DBS therapy according to the second therapy program.

Inventors

  • MOORE, LISA DENISE
  • HOENES, Benjamin Ray

Assignees

  • Boston Scientific Neuromodulation Corporation

Dates

Publication Date
20260513
Application Date
20240702

Claims (15)

  1. What is claimed is: 1. A system, comprising: a deep brain stimulator (DBS) configured to deliver a DBS therapy to a patient according to a first therapy program; and a processing system configured for use to: receive a logged event from a user or sensor indicative of an acute reduction in therapy; automatically identify a second therapy program for the DBS therapy to address the acute reduction in therapy; deliver the DBS therapy according to the second therapy program; prompt the user to report whether the user likes or dislikes the DBS therapy delivered according to the second therapy program; and control the DBS therapy based on the report by choosing a third therapy program when the user does not like the second therapy program, reverting to the first therapy program when the user does not like the second therapy program, or continuing to deliver the DBS therapy according to the second therapy program when the user likes the second therapy program.
  2. 2. The system of claim 1, wherein the logged event is indicative of a symptom known to the user that may be experienced by the patient and that is known to potentially cause the acute reduction in therapy, and the automatically identified second therapy program is an accessible program for targeting the symptom.
  3. 3. The system of claim 1, wherein the logged event is indicative of a side effect known to the user that may be experienced by the patient and that is known to the user to potentially cause the acute reduction in therapy, and the automatically identified second therapy program is an accessible program for targeting the side effect.
  4. 4. The system of claim 1, wherein the logged event from the user is indicative of an activity that corresponds to a set of symptoms or side effects that cause the first therapy to be suboptimal.
  5. 5. The system of claim 4, wherein the processing system is further configured for use to automatically request additional information when the logged event is received, wherein the additional information is requested using user-answered queries or is received via user-provided free text.
  6. 6. The system of any of claims 1-5, wherein a weighted summary map combines weights of clinical effects data into a cumulative score, and the second therapy program is automatically identified by altering the weights of symptoms in the clinical effects data, and identifying a program with a best estimated score.
  7. 7. The system of claim 6, wherein the second therapy program is automatically identified by placing a side effect barrier on the cumulative map, the automatically identified second therapy program has a best estimated score remaining outside of a side effect region.
  8. 8. The system of any of claims 1-7, wherein the processing system is further configured for altering a workflow to simplify patient interaction when the logged event is repeatedly received.
  9. 9. The system of claim 8, wherein the workflow is altered by introducing a schedule for delivering the DBS according to the second therapy schedule.
  10. 10. The system of any of claims 1-9, wherein the processing system is further configured for determining if a program limit has been reached the DBS therapy is delivered according to another therapy program, and only delivering the DBS therapy according to the other therapy program when a program limit has not been reached.
  11. 11. The system of any of claims 1-10, wherein the user includes at least one of the patient or a caregiver for the patient.
  12. 12. The system of any of claims 1-11, wherein the processing system is further configured for: receiving a report on the second therapy, by prompting the user or automatically sensing a detectable response, within a first time period after beginning to deliver the DBS therapy according to the second therapy, and continuing to deliver the DBS therapy according to the second therapy program when the report is good; and determining whether to continue to deliver the DBS therapy according to the second therapy program within a second time period after beginning to deliver the DBS therapy based on another report by prompting the user or automatically sensing the detectable response or another detectable response, wherein the second time period is longer than the first time period.
  13. 13. The system of claim 12, wherein at least one of the first time period or the second time period depends on an event type for the logged event.
  14. 14. The system of any of claims 12-13, wherein the processing system is further configured for adding at least one prompt for the user to report on the second therapy within at least one time period longer than the second time period.
  15. 15. The system of any of claims 1-14, wherein the processing system is further configured for receiving additional or sensed logged events and using the logged or sensed events to identify patterns of therapy reduction and develop event-related adjustments to the DBS therapy for the identified patterns.

Description

PATIENT FEEDBACK SYSTEM FOR ADJUSTING STIMULATION PARAMETERS CLAIM OF PRIORITY [0001] This application claims the benefit of U.S. Provisional Application No. 63/525,116 filed on July 5, 2023, which is hereby incorporated by reference in its entirety. TECHNICAL FIELD [0002] This document relates generally to medical systems, and more particularly, but not by way of limitation, to systems, devices, and methods for delivering therapy using feedback to address acute reductions in therapy. BACKGROUND [0003] Medical devices may include therapy-delivery devices configured to deliver a therapy to a patient and/or monitors configured to monitor a patient condition via user input and/or sensor(s). For example, therapy-delivery devices for ambulatory patients may include wearable devices and implantable devices, and further may include, but are not limited to, stimulators (such as electrical, thermal, or mechanical stimulators) and drug delivery devices (such as an insulin pump). An example of a wearable device includes, but is not limited to, transcutaneous electrical neural stimulators (TENS), such as may be attached to glasses, an article of clothing, or a patch configured to be adhered to skin. Implantable stimulation devices may deliver electrical stimuli to treat various biological disorders, such spinal cord stimulators (SCS) to treat chronic pain, cortical and Deep Brain Stimulators (DBS) to treat motor and psychological disorders, Peripheral Nerve Stimulation (PNS), Functional Electrical Stimulation (FES), and other neural stimulators to treat urinary incontinence, sleep apnea, shoulder subluxation, etc. By way of example and not limitation, a DBS system may be configured to treat tremor, bradykinesia, and dyskinesia and other motor disorders associated with Parkinson’s Disease (PD). [0004] Closed loop stimulation adjustment is becoming an expected feature in next generation systems. There are closed loop systems that rely on internal physiological sensing or longer-term external sensing. However, these systems may not be able to counter an acute reduction in therapeutic outcome because the system may not have the full context, from sensing alone, of what is really leading to the reduction in therapeutic outcome. For example, a patient may quickly develop a problem with eating dinner, even though the patient had no trouble eating lunch. Examples of an acute reduction in therapy include a quick reduction in relief in a symptom that is being treated by the therapy, a quick worsening side effect when the therapy is delivered, or a quickly-developed problem with an activity performed by the patient. There is a need in the art for improved therapy system to address such acute reductions in therapy. SUMMARY [0005] Embodiments of the present subject matter provide improved systems for counteracting an acute reduction in therapeutic outcome. Some embodiments provide a system capable of using user logging, such as log(s) entered by a patient and/or caregiver, to respond to acute reductions in therapy, identify patterns of therapy reduction, and develop novel event related adjustments for patients. The feedback may include current symptoms, side effects and patient activities to adjust weighting for symptoms/side effects and select a stimulation program. The stimulation program may be a tested and saved program in the stimulator system. DBS is provided as an example of a stimulator system. However, the present subject matter may be implemented with other medical device systems, including other neural stimulation systems such as SCS, PNS, FES, and TENS. [0006] An example (e.g., “Example 1”) of a system may include a deep brain stimulator (DBS) configured to deliver a DBS therapy to a patient according to a first therapy program, and a processing system. The processing system may be configured for use to receive a logged event from a user or sensor indicative of an acute reduction in therapy, automatically identify a second therapy program for the DBS therapy to address the acute reduction in therapy, deliver the DBS therapy according to the second therapy program, prompt the user to report whether the user likes or dislikes the DBS therapy delivered according to the second therapy program, and control the DBS therapy based on the report. Controlling the DBS therapy based on the report may include choosing a third therapy program when the user does not like the second therapy program, reverting to the first therapy program when the user does not like the second therapy program, or continuing to deliver the DBS therapy according to the second therapy program when the user likes the second therapy program. [0007] In Example 2, the subject matter of Example 1 may optionally be configured such that the logged event is indicative of a symptom known to the user that may be experienced by the patient and that is known to potentially cause the acute reduction in therapy, and the automatically identified second therapy progra