Aligned Electrospun Nerve Conduits for Large Gap Repair

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Solution Overview

Problem

Current nerve repair methods, such as end-to-end suturing and autograft/allograft tissue application, face limitations like donor site morbidity and immunogenicity risks, and existing nerve guidance conduits lack optimal physical topography and chemical cues for nerve regeneration, especially for larger nerve gaps.

Innovation Solution

The development of implantable nerve guidance conduits with integrated spiral structured porous sheets and aligned electrospun fibers, featuring reserved chambers for nerve stumps and a dense outer fibrous tube for structural support and scar tissue prevention, which enhance cell migration and regeneration.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If end-to-end suturing is used for nerve repair, then the procedure is simple and direct, but it cannot be performed when the nerve gap is larger than 1 cm

Engineering Contradiction:
Improvesimplicity of procedureVSAvoidapplicability to larger nerve gaps
Core Design Contradiction:
Ease of operationVSAdaptability or versatility

Solution Approach 1:

The patent introduces a nerve guidance conduit as an intermediary device that bridges the gap between severed nerve ends. The conduit contains aligned electrospun fibers that serve as a scaffold for axonal regeneration, enabling nerve repair across gaps larger than 1 cm while maintaining a relatively simple surgical procedure.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The invention extracts the limitation of direct suturing by removing the requirement for direct contact between nerve ends. The conduit acts as a separate structural element that spans the gap, allowing nerve regeneration without the constraint of gap size that plagues direct suturing methods.

Inventive Principle:
Principle #2Taking out (Extraction)

2Reliability

If autograft tissue is used for nerve repair, then natural nerve tissue can be replaced, but donor site morbidity occurs and the condition may be exacerbated

Engineering Contradiction:
Improvebiocompatibility and natural tissue replacementVSAvoiddonor site morbidity
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The nerve guidance conduit employs porous electrospun fibers that create a three-dimensional scaffold mimicking the natural extracellular matrix. This porous structure allows cell infiltration, nutrient transport, and axonal growth while eliminating the need for donor tissue harvesting, thus avoiding donor site morbidity.

Inventive Principle:
Principle #31Porous materials

Solution Approach 2:

The conduit utilizes composite material structures combining electrospun polymer fibers with potential bioactive coatings or embedded growth factors. This composite approach provides both structural support and biological cues for nerve regeneration without requiring autograft tissue.

Inventive Principle:
Principle #40Composite materials

3Object-affected harmful factors

If allograft tissue is used for nerve repair, then nerve tissue can be replaced without donor site morbidity, but immunogenicity risks arise

Engineering Contradiction:
Improveelimination of donor site morbidityVSAvoidrisk of immunogenicity
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The nerve guidance conduit functions as a temporary, biodegradable scaffold that provides structural support during the critical regeneration period. The electrospun fibers are designed to gradually degrade as native tissue forms, eliminating the need for permanent foreign material and reducing immunogenicity risks associated with allografts.

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

Solution Approach 2:

The invention changes the material parameters from permanent allograft tissue to temporarily functional electrospun scaffolds with controlled degradation rates. This parameter change allows the conduit to provide necessary structural support initially, then gradually disappear as regeneration completes, avoiding long-term immunogenic responses.

Inventive Principle:
Principle #35Parameter changes

4Adaptability or versatility

If conventional nerve guidance conduits are used, then some limitations of autograft and allograft are overcome, but they lack proper physical topography and chemical cues for nerve regeneration

Engineering Contradiction:
Improveovercoming limitations of graft methodsVSAvoidefficacy for nerve regeneration
Core Design Contradiction:
Adaptability or versatilityVSReliability

Solution Approach 1:

The electrospun fibers in the conduit are arranged in highly aligned parallel configurations that mimic the natural orientation of nerve fascicles and axons. This aligned topography provides contact guidance cues that direct axonal growth along the conduit length, significantly improving regeneration efficacy compared to conventional non-aligned conduits.

Inventive Principle:
Principle #14Spheroidality (Curvature)

Solution Approach 2:

The conduit employs local quality variations through electrospun fiber alignment patterns and potential gradient structures within the scaffold. Different regions of the conduit can be optimized with specific fiber densities, orientations, or bioactive molecule concentrations to match the local requirements of nerve regeneration at different positions along the conduit.

Inventive Principle:
Principle #3Local quality

5Adaptability or versatility

If most existing nerve guidance conduits are used, then they are available for various nerve gaps, but they are limited to a critical nerve gap of approximately 4 cm

Engineering Contradiction:
Improveavailability for various nerve gapsVSAvoidmaximum effective nerve gap
Core Design Contradiction:
Adaptability or versatilityVSLength of moving object

Solution Approach 1:

The electrospun fiber scaffold provides dynamic mechanical properties that allow the conduit to accommodate varying gap lengths and maintain structural integrity. The flexible yet aligned fiber structure can be configured for different lengths while preserving the critical aligned topography needed for regeneration, extending the effective treatment range beyond 4 cm.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The invention extends the effective treatment range by utilizing the three-dimensional aligned fiber architecture within the conduit. This dimensional approach allows the scaffold to provide structural support and guidance cues over longer distances by distributing mechanical loads and maintaining alignment integrity across extended lengths, overcoming the 4 cm limitation of conventional conduits.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

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

These conduits improve mechanical strength, facilitate nerve regeneration across larger gaps, reduce recovery time, and promote uniform tissue regeneration, outperforming existing methods by providing aligned topographical cues and structural support for nerve repair.

Implementation Method 1

the presence of microfilaments has been demonstrated to enhance axonal regeneration and provide contact guidance for the regenerating axons

Methodology Applied
Scientific EffectContact guidance:

Implementation Method 2

an interconnected porous structure that facilitates cell migration and nutrient diffusion

Methodology Applied
Scientific EffectDiffusion: Diffusion

Implementation Method 3

a highly aligned set of electrospun fibers are present within the surface channels

Methodology Applied
Scientific EffectElectrospinning:

Data Source

PatentUS10363041B2Implantable nerve guidance conduits having polymer fiber guidance channel
Publication Date: 2019.07.30 STEVENS INSTITUTE OF TECHNOLOGY
  • US10363041B2 patent drawing
  • US10363041B2 patent drawing
  • US10363041B2 patent drawing

AI summary

A nerve guidance conduit includes one or more guidance channels formed as porous polymeric structures. The guidance channels are within an outer tubular structure that includes randomly-oriented nanofibers. The guidance channels may have electrospun nanofibers on their inner and outer surfaces in a parallel alignment with the guidance channels. Such aligned nanofibers may also be present on the inner surface of the outer tubular structure. The outer surfaces of the guidance channels and the inner surface of the tubular structure define additional guidance channels. Such a nerve guidance conduit provides augmented surface areas for providing directional guidance and enhancing peripheral nerve regeneration. The structure also has the mechanical and nutrient transport requirements required over long regeneration periods.