Flexible Lead Ribbon for Minimally Invasive Nerve Stimulation

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Solution Overview

Problem

Current nerve stimulation therapies often require invasive and costly procedures for chronic conditions, lacking a minimally invasive, cost-effective, and easily removable option for temporary or trial stimulation.

Innovation Solution

A lead ribbon design featuring metallic traces sandwiched between polymer layers, forming a flexible ribbon that can be inserted through a small needle, expanding to engage tissue for retention, with exposed electrodes and contacts, allowing for minimally invasive implantation, cost-effectiveness, and easy removal.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional chronic nerve stimulation leads are used, then reliable long-term nerve stimulation is achieved, but the procedure becomes invasive and costly

Engineering Contradiction:
Improvenerve stimulation reliabilityVSAvoidprocedure invasiveness
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The lead is segmented into modular components: a flexible printed circuit board with discrete electrode contacts, a separate connector, and a reusable cable assembly. This segmentation allows for simplified implantation procedures while maintaining reliable electrical connections for chronic stimulation.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The lead utilizes a flexible printed circuit board as the conductor carrier, replacing traditional rigid lead structures. This flexible film design enables minimally invasive implantation through smaller access points while maintaining structural integrity and electrical reliability for long-term use.

Inventive Principle:
Principle #30Flexible shells and thin films

2Duration of action of stationary object

If traditional chronic stimulation implants are used, then long-term therapy is provided, but the cost increases significantly

Engineering Contradiction:
Improvetherapy durationVSAvoidmanufacturing cost
Core Design Contradiction:
Duration of action of stationary objectVSEase of manufacture

Solution Approach 1:

The lead incorporates a disposable sterile connector assembly that can be discarded after a single use, eliminating the need for expensive sterilization processes and reducing manufacturing costs while still providing for long-term chronic stimulation through the reusable cable and pulse generator components.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The design changes the manufacturing parameters by using standard flexible printed circuit board fabrication processes instead of traditional lead wiring methods, significantly reducing manufacturing costs while maintaining the capability for long-term implantation and stimulation.

Inventive Principle:
Principle #35Parameter changes

3Duration of action of stationary object

If permanent leads are implanted, then chronic stimulation is achieved, but removal becomes difficult

Engineering Contradiction:
Improvestimulation durationVSAvoidremoval ease
Core Design Contradiction:
Duration of action of stationary objectVSEase of operation

Solution Approach 1:

The lead system is segmented into permanently implanted components (flexible circuit board with electrodes) and removable components (connector assembly). This segmentation allows the stimulation function to continue chronically while enabling easy removal and replacement of the connector portion without disturbing the implanted electrodes.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

A reusable cable assembly acts as an intermediary between the implanted lead and the external pulse generator. This intermediary can be easily connected and disconnected, allowing for simple removal and reconfiguration while maintaining the permanent implant for chronic therapy.

Inventive Principle:
Principle #24Intermediary (Mediator)

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

Enables a cost-effective, minimally invasive, and easily removable temporary nerve stimulation solution that can be used for both acute and chronic conditions, including cranial nerve stimulation, providing effective tissue engagement and ease of use in medical settings.

Implementation Method 1

When the needle is removed, the formed ribbon may relax and engage the tissue providing a means of retention

Methodology Applied
Scientific EffectElastic deformation: Elasticity

Data Source

PatentUS20240216675A1Lead for the temporary stimulation of a peripheral nerve
Publication Date: 2024.07.04 NEXTERN INNOVATION LLC
  • US20240216675A1 patent drawing
  • US20240216675A1 patent drawing
  • US20240216675A1 patent drawing

AI summary

Apparatus and associated methods relate to using a lead ribbon with a catheter. In an illustrative example, the lead ribbon may include exposed electrode pads disposed on a surface in electrical communication with a conductive trace running towards a proximal end of the lead ribbon. For example, the lead ribbon may be bent and inserted within the catheter. For example, a bent end of the lead ribbon may be disposed at the catheter distal end. For example, in a deploy mode, the bent end extends out of the catheter distal end to form a lead ribbon ring. For example, the lead ribbon ring may engage a lumen of tissue and the exposed electrode pads may be oriented radially outward from the horizontal plane in electrical contact with the tissue. Various embodiments may advantageously provide a cost effective. damage mitigated, and size adjustable intro vivo simulation device.