Spinal Cord Stimulation Modeling for Sub-Perception Electrode Selection

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Solution Overview

Problem

Spinal cord stimulation (SCS) therapy often causes paresthesia, and achieving sub-perception therapy without paresthesia requires longer wash-in periods and increased power consumption, complicating electrode selection and battery management.

Innovation Solution

Employing supra-perception stimulation during the sweet spot search to quickly identify effective electrodes, followed by titrating to sub-perception levels, reduces wash-in time and optimizes electrode selection for immediate sub-perception therapy.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If sub-perception stimulation is used to avoid paresthesia, then patient comfort is improved, but wash-in time increases and power consumption increases

Engineering Contradiction:
ImproveparesthesiaVSAvoidwash-in time
Core Design Contradiction:
Object-affected harmful factorsVSLoss of time

Solution Approach 1:

The system performs preliminary supra-perception stimulation during the sweet spot search to quickly identify effective electrodes before transitioning to sub-perception therapy. This preliminary action of electrode identification using supra-perception stimulation eliminates the need for prolonged wash-in periods when initiating sub-perception therapy, as the effective electrodes are already determined beforehand.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The system dynamically changes stimulation parameters (amplitude, pulse width, frequency) based on the sweet spot search results and patient feedback. By adjusting these parameters from supra-perception levels during electrode selection to sub-perception levels for therapy, the system optimizes both the speed of electrode identification and the comfort of ongoing therapy.

Inventive Principle:
Principle #35Parameter changes

2Object-affected harmful factors

If sub-perception stimulation is used to avoid paresthesia, then patient comfort is improved, but power consumption increases

Engineering Contradiction:
ImproveparesthesiaVSAvoidpower consumption
Core Design Contradiction:
Object-affected harmful factorsVSUse of energy by moving object

Solution Approach 1:

The system performs preliminary supra-perception stimulation during the sweet spot search to quickly identify effective electrodes before transitioning to sub-perception therapy. This preliminary action of electrode identification using supra-perception stimulation eliminates the need for prolonged wash-in periods when initiating sub-perception therapy, as the effective electrodes are already determined beforehand.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The system dynamically changes stimulation parameters (amplitude, pulse width, frequency) based on the sweet spot search results and patient feedback. By adjusting these parameters from supra-perception levels during electrode selection to sub-perception levels for therapy, the system optimizes both the speed of electrode identification and the comfort of ongoing therapy.

Inventive Principle:
Principle #35Parameter changes

3Productivity

If supra-perception stimulation is used during sweet spot search, then electrode selection speed is improved, but temporary patient discomfort occurs

Engineering Contradiction:
Improveelectrode selection speedVSAvoidpatient discomfort
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The system performs preliminary supra-perception stimulation during the sweet spot search to quickly identify effective electrodes before transitioning to sub-perception therapy. This preliminary action of electrode identification using supra-perception stimulation eliminates the need for prolonged wash-in periods when initiating sub-perception therapy, as the effective electrodes are already determined beforehand.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The system uses periodic stimulation pulses during the sweet spot search, allowing brief intervals of supra-perception stimulation for electrode identification followed by transitions to sub-perception levels. This periodic alternation enables efficient electrode selection while minimizing the duration and impact of patient discomfort.

Inventive Principle:
Principle #19Periodic action

Data Source

PatentEP4215237B1Spinal cord stimulation system with modelling relationships between stimulation parameters for automatic customization of sub-perception therapy
Publication Date: 2025.08.27 BOSTON SCI NEUROMODULATION CORP
  • EP4215237B1 patent drawingFigure 1~3
  • EP4215237B1 patent drawingFigure 4
  • EP4215237B1 patent drawingFigure 5

AI summary

The present invention relates to a system, comprising a stimulator device comprising a plurality of electrodes, and an external device configured to program the stimulator device with at least an amplitude, a pulse width, and a frequency of stimulation pulses to be provided at one of more of the plurality of electrodes, wherein the external device comprises a non-transitory computer readable medium including instructions that, when executed, are configured to cause the external device to provide a Graphical User Interface (GUI) on the external device that allows a user input to adjust the frequency and at least one of the pulse width or the amplitude of the stimulation pulses, but wherein the GUI limits adjustment of the frequency and the at least one the pulse width or the amplitude to coordinates within a model, wherein the model is derived for a particular patient and comprises information indicative of a plurality of coordinates, wherein each coordinate comprises a frequency, a pulse width, and an amplitude predicted to provide optimal stimulation for the patient.