Decellularized Nerve Allografts for Motor Function Restoration
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Solution Overview
Problem
Current methods for nerve reconstruction, such as autografts, are limited by supply, diameter, and length, and result in donor site morbidity, making it difficult to reconstruct nerves with multiple segmental defects effectively.
Innovation Solution
Decellularized nerve allografts prepared using elastase and stored under cold conditions without freezing can be used to repair nerve injuries or bridge severed nerves, restoring motor function by reducing immunogenicity and maintaining structural integrity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If autograft is used for nerve reconstruction, then motor function restoration is achieved, but donor site morbidity and limited supply occur
Solution Approach 1:
The patent uses decellularized nerve allograft as an intermediary material between the damaged nerve ends. This allograft has been treated to remove immunogenic cellular components while preserving the extracellular matrix structure, serving as a mediator that facilitates nerve regeneration without requiring donor site harvesting from the patient.
Solution Approach 2:
The patent creates a copy of the native nerve structure by using decellularized allograft that replicates the extracellular matrix architecture. This copied structure provides the necessary scaffolding for regenerating nerve fibers without requiring actual autograft tissue, thereby avoiding donor site morbidity while maintaining functional restoration capabilities.
2Reliability
If autograft is used for nerve reconstruction, then motor function restoration is achieved, but limited length and diameter availability occur
Solution Approach 1:
The patent employs nerve allografts that can serve multiple length and diameter requirements from a single donor source. The decellularized allografts can be sectioned and configured to match various defect sizes without being constrained by the limited dimensions of autograft harvests, providing universal applicability across different nerve injury scenarios.
3Duration of action of stationary object
If nerve allograft is frozen for storage, then long-term preservation is achieved, but structural integrity deteriorates
Solution Approach 1:
The patent changes the storage parameter from freezing to cold storage at refrigerated temperatures (2-8°C). This parameter modification preserves the structural integrity of the nerve allograft extracellular matrix while still allowing for long-term preservation. The decellularized state of the graft enables this cold storage approach without requiring freezing, thereby maintaining both duration of storage and structural strength.
4Object-affected harmful factors
If decellularization is performed to reduce immunogenicity, then immune rejection is reduced, but processing complexity increases
Solution Approach 1:
The patent applies decellularization processes that extract and remove immunogenic cellular components (such as nuclei and cytoplasmic elements) from the nerve allograft while leaving the extracellular matrix intact. This extraction of harmful cellular material reduces immunogenicity and subsequent immune rejection, while the standardized decellularization protocols manage processing complexity through established methods.
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 use of decellularized nerve allografts allows for effective nerve reconstruction with reduced immunogenicity and preserved structural properties, enabling restored motor function in injured or severed nerves, evident at 12 weeks or longer post-implantation.
Implementation Method 1
contacting nerve tissue with from about 0.01 units/mL to about 1 unit/mL (e.g., about 0.05 units/mL) of elastase for at least about four hours (e.g., about 16 hours) to prepare the decellularized nerve graft
Implementation Method 2
the decellularized nerve graft was not frozen and was stored under cold conditions of from about 1.5 °C to about 6.5 °C
Data Source
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AI summary
This document relates to decellularized nerve allografts. For example, decellularized nerve allografts and methods and materials for using decellularized nerve allografts to repair nerve injuries or bridge a severed nerve are provided.