Sub-threshold Electrical Stimulation for Chronic Pain

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Solution Overview

Problem

Current electrical stimulation therapies for conditions like chronic pain often require high intensities that are perceived by patients, leading to paresthesia and limited battery life in implantable devices, with little guidance on minimum amplitude requirements and potential for increased power consumption.

Innovation Solution

The development of sub-threshold electrical stimulation therapy that delivers electrical signals with intensities significantly lower than a patient's paresthesia or perception threshold, using medical devices to generate and deliver stimulation signals with intensities less than 40% of the threshold, modulating nerve fibers without activating dorsal column fibers to provide pain relief without paresthesia.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If high intensity electrical stimulation is used to treat chronic pain, then pain relief is achieved, but patient perception of stimulation increases leading to paresthesia and limited battery life

Engineering Contradiction:
Improvepain relief effectivenessVSAvoidpatient perception and paresthesia
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent applies parameter changes by transitioning from high intensity stimulation to sub-threshold intensity levels (below 40% of paresthesia threshold). This fundamental parameter change allows the stimulation to remain effective for pain relief while falling below the patient's perception threshold, thereby eliminating paresthesia and extending battery life without sacrificing therapeutic effectiveness

Inventive Principle:
Principle #35Parameter changes

2Reliability

If high intensity electrical stimulation is used to treat chronic pain, then pain relief is achieved, but power consumption increases and battery life is limited

Engineering Contradiction:
Improvepain relief effectivenessVSAvoidpower consumption
Core Design Contradiction:
ReliabilityVSUse of energy by moving object

Solution Approach 1:

The patent fundamentally changes the intensity parameter from high to sub-threshold levels (below 40% of paresthesia threshold). This parameter change directly reduces the energy required for stimulation, lowering power consumption and extending battery life while maintaining pain relief effectiveness through alternative mechanisms that do not require high intensity signals

Inventive Principle:
Principle #35Parameter changes

3Reliability

If conventional electrical stimulation is used, then therapeutic effect is achieved, but minimum amplitude requirements are unclear leading to suboptimal therapy

Engineering Contradiction:
Improvetherapeutic effectVSAvoidamplitude parameter definition
Core Design Contradiction:
ReliabilityVSManufacturing precision

Solution Approach 1:

The patent establishes clear parameter definitions by defining sub-threshold stimulation as intensity levels below 40% of the paresthesia threshold. This parameter clarification provides precise guidance for programming stimulators, replacing the previous lack of minimum amplitude guidelines with a well-defined parameter range that ensures therapeutic effectiveness while minimizing side effects and energy consumption

Inventive Principle:
Principle #35Parameter changes

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

This approach allows for effective pain relief at lower intensities, reducing power consumption and extending battery life, while minimizing patient perception of the stimulation, thus providing therapeutic benefits with reduced side effects and longer device operation.

Implementation Method 1

generating and delivering an electrical stimulation signal with intensity that is significantly less than a paresthesia or perception threshold of the patient

Methodology Applied
Scientific EffectElectrical stimulation: Electric Field

Data Source

PatentEP4003494B1Titration for sub-threshold electrical stimulation therapy
Publication Date: 2024.04.17 MEDTRONIC INC
  • EP4003494B1 patent drawingFigure 1
  • EP4003494B1 patent drawingFigure 2
  • EP4003494B1 patent drawingFigure 3

AI summary

In some examples, a medical device is configured to deliver sub-threshold electrical stimulation therapy to a patient at a stimulation intensity that is significantly less than a perception or paresthesia threshold intensity level for the patient. The medical device may determine the particular intensity level for the patient through a titration process. The medical device may titrate automatically or based upon the input of the patient, a clinician or a physician.