Multi-branch Stimulation Electrode for Peripheral Nerve Field Stimulation

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Solution Overview

Problem

Current spinal cord stimulation systems for treating neuropathic pain are bulky, lead to high device failure rates, and require complex implantation procedures, resulting in increased surgical risks and prolonged recovery times due to their design for spinal cord stimulation rather than peripheral nerve stimulation.

Innovation Solution

A neurostimulation system featuring an implantable pulse generator and a multi-branch electrode array with stiffening components and adjustable electrode contacts, allowing for non-ablative electrical signal delivery directly to nerve tissues, facilitating easier implantation and broader area treatment with reduced need for lead tunneling across joints.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If spinal cord stimulation systems are used for peripheral nerve stimulation, then pain relief can be achieved, but device complexity and surgical risk increase due to bulky design and complex implantation procedures

Engineering Contradiction:
Improvedevice failure rateVSAvoidimplantation procedure complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The electrode array is divided into multiple independent branches that can be separately deployed and positioned. Each branch contains electrode contacts that can be independently configured, allowing the system to treat multiple peripheral nerve sites simultaneously while simplifying the overall implantation process through modular deployment from a single insertion point

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The multi-branch electrode array is nested within a delivery catheter during implantation. The compressed branches are contained within the catheter lumen, allowing percutaneous insertion through minimal incision. Upon deployment, the branches expand outward from the catheter in a controlled manner, transforming from a compact insertable form to a deployed configuration that spans the target tissue area

Inventive Principle:
Principle #7Nested doll (Nesting)

2Reliability

If traditional lead placement is used for peripheral nerve stimulation, then nerve stimulation can be achieved, but surgical recovery time increases due to extensive lead tunneling across joints

Engineering Contradiction:
Improvesurgical recovery timeVSAvoidimplantation ease
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The electrode array is extracted from the delivery catheter and deployed directly into the subcutaneous tissue plane without requiring leads to tunnel through muscle and across joints. The branches are positioned in the subcutaneous space where they can be secured with anchors, eliminating the need for complex submuscular lead routing and associated recovery time

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The delivery catheter serves as an intermediary tool that enables percutaneous insertion of the electrode array through minimal incision. The catheter provides a guided pathway for inserting the compressed branches, which then expand and deploy in the target tissue plane, eliminating the need for extensive surgical exposure and lead tunneling

Inventive Principle:
Principle #24Intermediary (Mediator)

3Ease of operation

If multi-branch electrode array is deployed in subcutaneous tissue, then easier implantation is achieved, but maintaining planar configuration becomes challenging without stiffening components

Engineering Contradiction:
Improveimplantation easeVSAvoidbranch configuration stability
Core Design Contradiction:
Ease of operationVSStability of the object's composition

Solution Approach 1:

Stiffening components are pre-integrated into the electrode array branches before implantation. These components provide structural rigidity that maintains the planar configuration of the branches during the implantation process and after deployment, ensuring the electrodes remain in the intended configuration without requiring complex deployment mechanisms or post-implantation adjustment

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The electrode array branches are constructed as composite structures combining conductive electrode materials with stiffening components. This composite design provides both the electrical functionality and the mechanical rigidity needed to maintain the planar configuration in the compliant subcutaneous tissue environment, where flexible materials alone would fail to maintain geometric stability

Inventive Principle:
Principle #40Composite materials

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 effective pain relief with reduced surgical complexity and lower device failure rates by enabling direct stimulation of peripheral nerves, minimizing the need for extensive lead placement and reducing post-surgical complications.

Implementation Method 1

at least some of the branches include stiffening components that increase the stiffness of the branches to facilitate blunt dissecting by the branches

Methodology Applied
Scientific EffectStiffening:

Implementation Method 2

The multi-branch electrode array can include a plurality of branches. In some embodiments, at least some of the branches each include a plurality of electrode contacts

Methodology Applied
Scientific EffectElectrical conduction: Conduction (electrical)

Data Source

PatentEP2991726B1Multi-branch stimulation electrode for subcutaneous field stimulation
Publication Date: 2018.07.25 ALFRED E MANN FOUND FOR SCI RES
  • EP2991726B1 patent drawingFigure 1
  • EP2991726B1 patent drawingFigure 2
  • EP2991726B1 patent drawingFigure 2A~2B

AI summary

A multi-branch stimulation electrode is disclosed herein. The multi-branch stimulation electrode can include a plurality of branches that extend from a hub. The branches can each include one or several stimulation contacts that can deliver an electrical current to tissue contacting the stimulation contacts. The stimulation contacts can be electrically connected with the lead. The lead can extend from the hub and can be connected with the pulse generator. The branches can include features to facilitate implantation including, for example, one or several removable stiffening elements.