Insulative Nerve Overwrap for Current Leakage and Tissue Ingrowth

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Solution Overview

Problem

Current nerve stimulation electrodes are difficult to install, prone to tissue ingrowth, and inefficient in directing current to the nerve, leading to increased power consumption and potential side effects.

Innovation Solution

A flexible electrically insulative sheet, made of materials like silicone with specific resistivity and thickness, wraps around a group of electrodes to reduce tissue ingrowth and concentrate current delivery to the nerve, improving implantation ease and therapeutic efficacy while conserving battery power.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If multiple electrode devices are attached to the nerve, then effective nerve stimulation is achieved, but the difficulty and time required for attachment increases significantly

Engineering Contradiction:
Improveeffective nerve stimulationVSAvoidattachment difficulty
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

Multiple electrode devices are combined into a single integrated electrode assembly that attaches to the nerve as one unit rather than separately attaching multiple devices. This merging approach maintains the therapeutic effectiveness of multiple electrodes while significantly simplifying the surgical procedure and reducing implantation time.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The electrode assembly is segmented into multiple electrically active electrodes within a single device structure. This allows each electrode to function independently for effective nerve stimulation while the entire assembly attaches to the nerve as one integrated unit, resolving the contradiction between needing multiple electrodes and wanting simplified attachment.

Inventive Principle:
Principle #1Segmentation

2Reliability

If electrodes are attached to the nerve, then nerve stimulation is achieved, but tissue ingrowth around and between electrodes hinders effectiveness and surgical removal

Engineering Contradiction:
Improvenerve stimulation effectivenessVSAvoidsurgical removal
Core Design Contradiction:
ReliabilityVSEase of repair

Solution Approach 1:

A flexible insulative sheet or coating is applied around the electrode assembly to prevent tissue ingrowth. This thin film barrier maintains electrical insulation and prevents fibrous tissue from growing between and around the electrodes, thereby preserving both the effectiveness of nerve stimulation and facilitating future surgical removal or adjustment of the electrodes.

Inventive Principle:
Principle #30Flexible shells and thin films

3Reliability

If current is applied to nerve stimulation electrodes, then therapeutic effect is achieved, but current passes into surrounding tissue rather than being directed into the nerve

Engineering Contradiction:
Improvetherapeutic effectVSAvoidpower consumption
Core Design Contradiction:
ReliabilityVSLoss of energy

Solution Approach 1:

The harmful current leakage into surrounding tissue is extracted or blocked by applying an insulative material around the electrodes. This extraction of the problematic current path redirects the electrical current to flow primarily through the nerve, improving energy efficiency and reducing power consumption while maintaining the therapeutic effect.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

An insulative material serves as an intermediary between the electrodes and the surrounding tissue. This intermediary layer guides and confines the electrical current to the intended target (the nerve) while preventing current leakage into adjacent tissues, thereby improving both therapeutic effectiveness and energy efficiency.

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

The insulative sheet significantly reduces current leakage into surrounding tissues, increases current injection into the nerve, stabilizes electrode position, and conserves battery resources, enhancing the effectiveness and efficiency of nerve stimulation systems.

Implementation Method 1

a flexible sheet of electrically insulative material, having an electrical resistivity of from about 108 ohm*m to about 1020 ohm*m

Methodology Applied
Scientific EffectElectrical resistance: Electrical Resistance

Data Source

PatentUS8965499B2Overwrap for nerve stimulation system
Publication Date: 2015.02.24 LIVANOVA USA INC
  • US8965499B2 patent drawing
  • US8965499B2 patent drawing
  • US8965499B2 patent drawing

AI summary

A nerve overwrap for an implantable nerve stimulation system includes a flexible sheet of electrically insulative material, having an electrical resistivity of from about 108 ohm*m to about 1020 ohm*m, adapted to wrap substantially around a group of nerve stimulation electrodes.