Neuromodulation System Fast Slow Sub-Perception Therapy

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Solution Overview

Problem

Conventional sub-perception neuromodulation therapies for pain relief have long wash-in transition times, making it difficult to evaluate therapeutic effectiveness and are susceptible to lead movement, while fast-acting sub-perception therapies are sensitive to lead positioning but offer quicker relief.

Innovation Solution

A neuromodulation system that delivers both fast-acting and slow-acting sub-perception therapies simultaneously, with fast-acting having a wash-in transition period less than two hours and slow-acting taking longer, to capture the benefits of quick relief and stability, using programmable stimulation parameters like frequency, pulse width, and amplitude to optimize pain relief without paresthesia.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional sub-perception neuromodulation therapy is delivered, then pain relief is achieved, but the wash-in transition time is long making it difficult to evaluate therapeutic effectiveness

Engineering Contradiction:
Improvetherapeutic effectiveness evaluationVSAvoidwash-in transition time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent segments the neuromodulation therapy into two distinct types: fast-acting sub-perception neuromodulation and slow-acting sub-perception neuromodulation. Each type has different stimulation parameters (fast-acting uses higher frequency 500-5000 Hz with shorter pulse width 20-100 μs, while slow-acting uses lower frequency 10-100 Hz with longer pulse width 100-500 μs). This segmentation allows the system to deliver both types simultaneously or alternately, enabling rapid evaluation of therapeutic effectiveness through the fast-acting component while the slow-acting component provides sustained long-term benefits.

Inventive Principle:
Principle #1Segmentation

2Speed

If fast-acting sub-perception therapy is delivered, then quick pain relief is achieved, but the therapy is sensitive to lead positioning

Engineering Contradiction:
Improvepain relief speedVSAvoidlead positioning precision
Core Design Contradiction:
SpeedVSManufacturing precision

Solution Approach 1:

The patent employs parameter changes by adjusting stimulation frequency and pulse width to create two distinct neuromodulation profiles. The fast-acting therapy uses high frequency (500-5000 Hz) and short pulse width (20-100 μs) to achieve rapid pain relief, while the slow-acting therapy uses low frequency (10-100 Hz) and long pulse width (100-500 μs) to provide broader, more position-tolerant coverage. By delivering both types simultaneously or alternately, the system compensates for the fast-acting therapy's sensitivity to lead positioning with the more robust slow-acting therapy, maintaining effective pain relief even if lead positioning is not perfectly precise.

Inventive Principle:
Principle #35Parameter changes

3Stability of the object's composition

If slow-acting sub-perception therapy is delivered, then stability against lead movement is achieved, but the wash-in transition time is very long

Engineering Contradiction:
Improvetherapy stabilityVSAvoidwash-in transition time
Core Design Contradiction:
Stability of the object's compositionVSLoss of time

Solution Approach 1:

The patent applies preliminary action by delivering fast-acting sub-perception neuromodulation first (or simultaneously with slow-acting therapy) to achieve rapid pain relief within minutes to hours. This fast-acting component acts as a preliminary measure that provides immediate therapeutic benefit while the slow-acting component continues to build its sustained effect over days to weeks. The fast-acting therapy serves as an initial effective intervention that bridges the gap during the prolonged wash-in period of the slow-acting therapy, ensuring continuous pain management without the long delay that would otherwise be experienced.

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentEP3921020B1Neuromodulation therapy system delivering different sub-perception neuromodulation types
Publication Date: 2023.08.16 BOSTON SCI NEUROMODULATION CORP
  • EP3921020B1 patent drawingFigure 1~3
  • EP3921020B1 patent drawingFigure 4~5
  • EP3921020B1 patent drawingFigure 6~7

AI summary

A neuromodulation system for use with electrodes to modulate a volume of neural tissue may include a waveform generator and a controller. The waveform generator may be configured to be electrically connected to the electrodes and provide an electrical waveform through at least some of the electrodes to provide a neuromodulation therapy. The controller may be configured to use a program to control the waveform generator to deliver a neuromodulation therapy by delivering both a fast-acting sub-perception neuromodulation and a slow-acting sub- perception neuromodulation. The fast-acting neuromodulation has a wash-in transition period less than a first time duration, and the slow-acting sub-perception neuromodulation has a wash- in transition period more than a second time duration, the second time duration being longer than the first time duration.