Percutaneous Electrical Stimulator Patch Assembly

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Solution Overview

Problem

Existing neurostimulation systems are cumbersome, prone to stimulation-induced pain, difficult to use, and require complex maintenance, limiting their acceptance as a widely effective treatment due to issues with lead placement, muscle fatigue, and the need for clinical skill and patient training.

Innovation Solution

A compact electrical stimulator system with a patch assembly that includes a power source and percutaneous electrodes, allowing for easy attachment and adjustment, featuring a user-friendly interface and programmable stimulus parameters, enabling convenient and effective neurostimulation with minimal user interaction.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If surface electrodes are used for electrical stimulation, then the device can be applied externally without surgery, but stimulation-induced pain occurs and patient tolerance is limited

Engineering Contradiction:
Improveease of applicationVSAvoidstimulation-induced pain
Core Design Contradiction:
Ease of manufactureVSObject-affected harmful factors

Solution Approach 1:

The patent introduces percutaneous leads as an intermediary component that penetrates through the skin to deliver electrodes directly to the target tissue. This mediator allows electrical stimulation to reach deeper structures without stimulating cutaneous pain receptors, thereby maintaining ease of external application while eliminating stimulation-induced pain.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces the mechanical surface electrode contact system with a percutaneous delivery system that uses a needle-like introducer to mechanically penetrate the skin and deposit the electrode tip at the target depth. This substitution allows precise electrode placement while avoiding continuous mechanical pressure on pain-sensitive surface receptors.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Object-affected harmful factors

If high frequency electrical stimulation is delivered to prevent pain, then pain is reduced, but muscle fatigue occurs early

Engineering Contradiction:
ImprovepainVSAvoidmuscle endurance
Core Design Contradiction:
Object-affected harmful factorsVSDuration of action of moving object

Solution Approach 1:

The patent enables precise control of stimulation parameters including frequency, pulse width, and amplitude through programmable circuitry. By optimizing these parameters based on the specific application and patient response, the system can provide effective pain relief while minimizing muscle fatigue, allowing for extended duration therapy.

Inventive Principle:
Principle #35Parameter changes

3Length of stationary object

If surface electrodes are used to stimulate deep muscles, then deep muscle stimulation is achieved, but overlying superficial muscles are also stimulated causing unwanted effects

Engineering Contradiction:
Improvestimulation depthVSAvoidunwanted stimulation
Core Design Contradiction:
Length of stationary objectVSObject-generated harmful factors

Solution Approach 1:

The percutaneous lead acts as an intermediary delivery mechanism that transports the electrode tip through the skin and subcutaneous tissue to place the active stimulating element directly at the target depth. This allows selective stimulation of deep muscles without activating overlying superficial muscles, eliminating unwanted stimulation effects.

Inventive Principle:
Principle #24Intermediary (Mediator)

4Ease of operation

If surface electrodes are used for neurostimulation, then the system can be operated externally, but complex lead placement and parameter adjustment require clinical skill and intensive patient training

Engineering Contradiction:
Improveexternal operationVSAvoidplacement complexity
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The patent incorporates programmable circuitry and control systems that allow the device to be configured and adjusted with minimal manual intervention. The system can store multiple stimulation programs and automatically adjust parameters, reducing the need for intensive patient training and simplifying operation while maintaining external applicability.

Inventive Principle:
Principle #25Self-service

5Reliability

If existing neurostimulation systems are used, then therapeutic benefits are provided, but the systems are large and awkward to manipulate and transport

Engineering Contradiction:
Improvetherapeutic effectivenessVSAvoiddevice size
Core Design Contradiction:
ReliabilityVSWeight of moving object

Solution Approach 1:

The patent divides the neurostimulation system into separate modular components: a percutaneous lead with electrode tip, a separate power source, and a control unit. This segmentation allows each component to be optimized independently and enables the system to be collapsed into a compact form for easy transport while maintaining full therapeutic functionality when assembled.

Inventive Principle:
Principle #1Segmentation

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

The system provides improved usability, reduced pain, extended battery life, and simplified maintenance, enhancing patient compliance and caregiver efficiency while ensuring safe and effective neurostimulation.

Implementation Method 1

a power source having a positive terminal and a negative terminal, each of the positive terminal and the negative terminal being coupled to the substrate, the power source being configured to provide power to an external stimulator coupled to the device

Methodology Applied
Scientific EffectBattery (electricity): Battery (electricity)

Implementation Method 2

an electrode assembly is coupled to the second surface of the substrate and at least one electrode of the electrode assembly is configured to contact bodily tissue and to facilitate transmission of an electrical current through the bodily tissue

Methodology Applied
Scientific EffectElectrical conduction: Conduction (electrical)

Data Source

PatentEP2563456B1Systems and methods for percutaneous electrical stimulation
Publication Date: 2020.06.03 SPR THERAPEUTICS
  • EP2563456B1 patent drawingFigure 1
  • EP2563456B1 patent drawingFigure 2~3A
  • EP2563456B1 patent drawingFigure 3B~4A

AI summary

Systems and methods according to the present invention relate to a substantially extracorporeal pulse generator system for electrical stimulation of one or more target nerve or their branches using one or more preferably percutaneous leads each having one or more electrodes implanted in, on, around, or near the target nerve. Improved systems include a patch assembly configured to be adhesively mounted to a patient's skin and an electrical stimulation assembly configured to be mechanically mounted to the patch assembly. A preferred patch assembly, in addition to provide mechanical mounting of the stimulation assembly, provides a power source for the stimulation assembly, and may further serve as a return electrode. Associated system components and methods of use are also provided.