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
Engineering 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
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
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
2Reliability
If processed nerve allografts or xenografts are used, then immunosuppression is not required, but the grafts are limited in size and availability
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
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
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
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
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
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
Data Source
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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.