Nerve Repair Device with Dual-Channel Enclosure
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Solution Overview
Problem
Current clinical methods for repairing peripheral nerve injuries are limited in success due to factors like injury mechanism, timing, and nerve type, and do not effectively prevent Wallerian degeneration or limit cell-body death, leading to delayed and incomplete reinnervation of motor and sensory targets.
Innovation Solution
A nerve repair device with a shaft having a dispensing channel and an evacuating channel, along with an enclosure that can be closed around the nerve repair site to deliver and remove solutions, facilitating the administration of pharmaceutical agents directly to the nerve to enhance regeneration and prevent degeneration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If current clinical methods (microsutures, autografts, conduits) are used for nerve repair, then the nerve ends are physically connected, but Wallerian degeneration is not prevented and reinnervation is delayed
Solution Approach 1:
The device applies PEG solution to fuse nerve ends immediately upon alignment, before Wallerian degeneration can occur. This preliminary fusion action prevents the natural degenerative process that would otherwise delay reinnervation, addressing both the reliability and time loss issues simultaneously.
Solution Approach 2:
Polyethylene glycol (PEG) serves as a chemical intermediary that facilitates immediate fusion of severed nerve axons. The PEG solution temporarily bridges the gap between nerve ends, creating stable fusion that prevents Wallerian degeneration and enables rapid reinnervation, overcoming the limitations of purely mechanical connection methods.
2Reliability
If PEG fusion is performed by manually applying solutions at the microsutured site, then axonal continuity can be restored, but the solution delivery is not localized and may affect surrounding tissues
Solution Approach 1:
The device incorporates a localized delivery system with a tip positioned precisely at the nerve repair site. The solution is delivered through a targeted channel that confines the PEG application to the immediate vicinity of the severed axons, ensuring local fusion without exposing surrounding healthy tissues to the chemical agent.
Solution Approach 2:
The delivery system is segmented into distinct functional components: a reservoir for PEG solution, a channeling system for controlled transport, and a localized tip for precise application. This segmentation enables independent optimization of each component and ensures that the solution is delivered only where needed at the nerve repair site.
3Productivity
If growth factors are locally administered to promote neuronal survival, then axon outgrowth is enhanced, but the administration requires complex delivery systems
Solution Approach 1:
The device merges the mechanical nerve alignment function with the chemical fusion function into a single integrated tool. The microsuture needle and PEG delivery channel are combined in one device, allowing simultaneous mechanical approximation and chemical fusion without requiring separate application steps or multiple devices.
Solution Approach 2:
The device is designed to be self-contained with the PEG solution reservoir integrated into the delivery mechanism. The surgeon loads the solution once and the device automatically delivers it to the nerve site without requiring external pumps or complex infusion systems, simplifying the overall delivery system while maintaining effective local administration.
Data Source
AI summary
A device may include a shaft with a dispensing channel, an evacuating channel, a proximal end, and a distal end. The device may further include an enclosure attached to the distal portion of the shaft, the enclosure having a first portion and a second portion that form a bore when the enclosure is closed. The device may further include a handle attached to the proximal end of the shaft, which is configured to open and close the enclosure. A method of delivering a solution to a nerve repair site may include obtaining such a device, closing its enclosure around the nerve repair site, delivering one or more solutions through the dispensing channel to the nerve repair site, removing one or more solutions through the evacuating channel from the nerve repair site, and opening the enclosure to remove it from the nerve repair site.