Nerve Coupler Stabilizing Severed Ends
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Solution Overview
Problem
Current nerve repair techniques using micro sutures fail to maintain stable apposition of nerve ends, leading to incomplete fusion and prolonged recovery due to Wallerian degeneration, which results in significant disability and economic loss.
Innovation Solution
A nerve coupler system that securely aligns and stabilizes severed nerve ends using a two-piece coupler with friction fit tabs and slots, delivering fusogens like PEG to facilitate immediate fusion and prevent apoptosis, while also incorporating electrodes for pain management.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If micro sutures are used to attach nerve ends together, then the nerve ends can be connected, but the apposition of nerve ends and axons is poor leading to incomplete fusion
Solution Approach 1:
The coupler is divided into two separate halves that can be independently positioned and secured to each nerve end. This segmentation allows for precise alignment and stable apposition of the nerve ends during fusion, while maintaining the ability to apply fusogens effectively. The two-half design resolves the contradiction by providing both precise positioning (improving apposition quality) and reliable connection (improving fusion completeness).
Solution Approach 2:
The coupler acts as an intermediary device between the two nerve ends, providing a stable platform that maintains close apposition during the fusion process. The coupler with its chambers for fusogen delivery serves as a mediator that enables both precise alignment and complete fusion, resolving the technical contradiction by facilitating both apposition quality and fusion reliability.
2Reliability
If micro sutures are used to attach nerve ends, then connection is achieved, but positional stability is poor allowing motion between nerve ends
Solution Approach 1:
The coupler's two-half design allows each half to be independently secured to a nerve end, creating multiple anchor points that collectively provide superior positional stability. This segmentation enables the system to maintain stable connection while preventing motion between nerve ends, resolving the contradiction between connection reliability and positional stability.
Solution Approach 2:
The coupler incorporates multiple functional elements including chambers for fusogen storage, electrodes for stabilization, and secure attachment mechanisms. This composite structure provides both connection stability and positional stability, resolving the technical contradiction by integrating multiple functions into a single device that addresses both requirements.
3Productivity
If nerve ends are brought together in close proximity, then fusion can occur, but Wallerian degeneration still occurs leading to prolonged recovery
Solution Approach 1:
The coupler is designed to be applied to the nerve ends before fusion occurs, with chambers that can be filled with fusogens to prevent Wallerian degeneration. This preliminary action of applying protective agents and stabilizing the nerve ends before the fusion process begins resolves the contradiction by preventing harmful degeneration while enabling rapid regeneration.
Solution Approach 2:
The coupler serves as an intermediary device that facilitates both the fusion process and the prevention of Wallerian degeneration. By providing a stable platform for fusogen delivery and maintaining nerve end stability, the coupler resolves the contradiction between rapid regeneration and prevention of harmful degeneration, enabling productive recovery without the harmful effects of Wallerian degeneration.
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 system enables rapid and complete nerve regeneration, reducing the need for invasive treatments and minimizing pain, allowing for substantial recovery of nerve function without the need for narcotic therapy or spinal cord stimulators.
Implementation Method 1
the axons can be fused relatively immediately with the application of a plurality of different compounds that are commonly termed 'fusogens'
Implementation Method 2
PEG is one such fusogen and the term should be taken broadly to include any biocompatible, chemical compound, or mixture of compounds, that facilitates fusion of severed nerve ends
Implementation Method 3
The first coupler half and the second coupler half can each include interengaging, friction fit tabs and slots for removably securing one to the other
Implementation Method 4
A chamber is adapted to surround a portion of the coupler so as to bathe the transected location in a therapeutic agent
Implementation Method 5
The coupler can include electrodes that apply predetermined electrical signals to the peripheral nerve
Data Source
AI summary
A system and method for repairing a damaged peripheral nerve is provided. A coupler includes a stabilizing assembly applied to a distal end of a damaged area of the nerve and applied to a proximal end of the damaged area, the coupler adapted so that the proximal end and the distal end are maintained in a stabile abutting relationship in which nerve repair can occur. A chamber is placed in proximity to the damaged area, having a therapeutic agent. Illustratively, the distal end and the proximal end are severed from each other. The coupler can define one of (a) coupler halves that surround the proximal end and the distal end and allow fixing members to be applied to the proximal end and the distal end and (b) cuffs that engage, and are fixed to, each of the proximal end and the distal end and are engaged by overlying coupler halves.