Neurostimulation Device Sub-Perception Stimulation Optimization

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Solution Overview

Problem

Spinal Cord Stimulation (SCS) therapy often causes paresthesia, a sensation that can be uncomfortable, and achieving effective sub-perception therapy without paresthesia is challenging due to the difficulty in determining the optimal electrode configuration and the need for prolonged experimentation.

Innovation Solution

Employing supra-perception sweet spot searching to quickly identify effective electrodes, which can then be used for sub-perception therapy, reducing the wash-in period and increasing the efficiency of finding optimal stimulation parameters, including frequency and pulse width, to minimize paresthesia and conserve battery power.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional SCS therapy is used to treat chronic pain, then pain relief is achieved, but paresthesia occurs which is uncomfortable for the patient

Engineering Contradiction:
Improvepain relief effectivenessVSAvoidparesthesia sensation
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent changes the stimulation parameters from traditional low-frequency (50-200 Hz) to high-frequency (1 kHz to 10 kHz) stimulation. This parameter change allows activation of different neural pathways that provide pain relief without triggering the uncomfortable paresthesia sensation associated with traditional SCS therapy

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent uses supra-perception stimulation during the sweet spot searching phase, applying stimulation intensity that exceeds the patient's perception threshold. This excessive action allows rapid identification of effective electrode configurations, which are then used at lower sub-perception intensities for ongoing therapy

Inventive Principle:
Principle #16Partial or excessive action

2Measurement precision

If traditional sweet spot searching is used to identify effective electrodes, then optimal electrode configuration is determined, but it requires prolonged experimentation time

Engineering Contradiction:
Improveelectrode configuration accuracyVSAvoidsweet spot searching time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent performs sweet spot searching using supra-perception stimulation before initiating sub-perception therapy. This preliminary action at higher intensities rapidly identifies the optimal electrode configuration, which is then used for the actual sub-perception therapy, significantly reducing the overall setup time

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent employs systematic periodic sweeping through different electrode combinations during the sweet spot searching phase. By methodically cycling through electrode configurations at supra-perception levels, the system efficiently identifies the optimal setup without requiring prolonged experimentation

Inventive Principle:
Principle #19Periodic action

3Object-affected harmful factors

If high frequency stimulation is used to achieve sub-perception therapy, then paresthesia is minimized, but battery power is consumed more rapidly

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

Solution Approach 1:

The patent uses supra-perception sweet spot searching as a preliminary phase to quickly identify effective electrode configurations. This allows the subsequent sub-perception therapy to use optimized electrode selections, reducing the overall energy required to achieve therapeutic effects

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent concentrates stimulation energy on specifically identified sweet spot electrodes rather than distributing it across all electrodes. This localized approach to high-frequency sub-perception stimulation reduces overall power consumption by activating only the most effective electrode combinations

Inventive Principle:
Principle #3Local quality

4Productivity

If sub-perception therapy parameters are optimized quickly, then therapy efficiency is improved, but the wash-in period is extended

Engineering Contradiction:
Improveparameter optimization speedVSAvoidwash-in period duration
Core Design Contradiction:
ProductivityVSDuration of action of moving object

Solution Approach 1:

The patent performs electrode configuration optimization using supra-perception stimulation before initiating sub-perception therapy. This preliminary optimization establishes the correct electrode setup in advance, allowing sub-perception therapy to begin immediately at effective parameters without requiring an extended wash-in period

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentEP4072655B1Neurostimulation device providing sub-perception stimulation
Publication Date: 2023.12.27 BOSTON SCI NEUROMODULATION CORP
  • EP4072655B1 patent drawingFigure 1~3
  • EP4072655B1 patent drawingFigure 4
  • EP4072655B1 patent drawingFigure 5

AI summary

Techniques are disclosed for adjusting sub-perception stimulation applied to a patient by an Implantable Pulse Generator (IPG). Adjustment can occur through use of one or more modulation functions associated with a stimulation modulation algorithm that adjusts the total charge provided by the stimulation to the patient as a function of time. The modulation function and algorithm can adjust the charge either by duty cycling the stimulation, or by adjusting the sub-perception stimulation parameters, and such adjustment can occur in the IPG or an external device. The stimulation modulation algorithm may use one or more models when adjusting the stimulation parameters to keep them at optimal values for sub- perception stimulation while simultaneous adjusting the charge stimulation provided as prescribed by the modulation function.