Fasciculated Nerve Grafts for Custom Nerve Gap Repair

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Solution Overview

Problem

Current nerve graft technologies are limited in size and availability, often requiring additional surgical sites and causing sensory loss, and do not adequately match the specific needs of individual patients, leading to suboptimal nerve regeneration outcomes.

Innovation Solution

The development of fasciculated nerve grafts that are substantially free of epineurial sheath and native extracellular matrix material, prepared by enzymatic treatment and washing to remove these components, allowing for customizable grafts of desired length and diameter, formed from combined nerve fascicles with biocompatible materials.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If nerve autografts are used to bridge nerve gaps, then nerve regeneration can be achieved, but additional operative sites are required causing sensory loss and permanent scars

Engineering Contradiction:
Improvenerve regenerationVSAvoidsensory loss and scars
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent extracts and removes the epineurial sheath and native extracellular matrix material from donor nerve tissue through enzymatic treatment, leaving only the useful nerve fascicles that can be used for grafting while discarding the harmful or unnecessary components

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent creates artificial nerve grafts that replicate the essential functional components of natural nerve tissue (the fascicles) without requiring a complete second-site nerve harvest, effectively copying the useful elements while avoiding the harmful side effects

Inventive Principle:
Principle #26Copying

2Reliability

If processed nerve allografts or xenografts are used, then immunosuppression is not required, but the grafts are limited in size and availability

Engineering Contradiction:
Improveimmunosuppression-free transplantationVSAvoidgraft size and availability
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The patent segments nerve tissue into individual fascicles that can be combined in various configurations to create grafts of different lengths and diameters, enabling customization to match specific patient needs while using processed allograft or xenograft tissue

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent enables dynamic customization of graft dimensions by allowing surgeons to select and combine different numbers and sizes of fascicle bundles according to the specific defect being repaired, making the graft system adaptable to various clinical scenarios

Inventive Principle:
Principle #15Dynamics

3Ease of manufacture

If commercially available nerve grafts are used, then immediate implantation is possible, but they do not match the specific length and diameter needs of individual patients

Engineering Contradiction:
Improveready-for-implantation availabilityVSAvoidcustomizable dimensions
Core Design Contradiction:
Ease of manufactureVSAdaptability or versatility

Solution Approach 1:

The patent divides processed nerve tissue into modular fascicle bundles that can be selectively combined during surgery to create custom-length and custom-diameter grafts, providing both immediate availability and dimensional customization

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent allows different portions of the graft to have different compositions or properties by selecting specific fascicles with appropriate characteristics for different segments of the nerve defect being repaired

Inventive Principle:
Principle #3Local quality

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

This approach enhances nerve regeneration by providing grafts that better match patient needs, improving surgical efficiency and reducing complications, while enabling the use of low-yield donor nerves, thus enhancing surgical outcomes.

Implementation Method 1

treating the at least one nerve tissue with an enzyme that degrades the native extracellular matrix material and the epineurial sheath

Methodology Applied
Scientific EffectEnzymatic degradation: Enzyme

Data Source

PatentEP4327838B1Fasciculated nerve grafts, methods of making the same, and methods of treatment using the same
Publication Date: 2026.03.11 AXOGEN CORP
  • EP4327838B1 patent drawingFigure 1~2
  • EP4327838B1 patent drawingFigure 3~4
  • EP4327838B1 patent drawingFigure 5~6

AI summary

The present disclosure provides fasciculated nerve grafts of customizable lengths and diameters, and methods of preparing the same. The grafts are made by digesting native extracellular matrix (ECM) around the nerve fascicles of a nerve tissue, and the epineurial sheath. One or more of the individual fascicles may then be entubulated in an entubulation material, embedded in or coated with a coating material, or both, to form a fasciculated nerve graft. The fasciculated nerve grafts are customizable and designed to bridge nerve gaps; the modularity of the fasciculated nerve graft allows for restoring continuity to nerve defects of virtually any length and allows for matching the diameter of the patient's recipient nerve.