Impact

Global

In the United States alone, peripheral nerve injuries affect approximately 5% of all trauma patients and up to 1% of the entire populations. Today, there are few approaches in treating peripheral nerve damage. While allografts and the use of nerve conduits have shown some promise, the short comings of these methods leave room for new and improved technologies for peripheral nerve injury treatment. If this nerve lengthening actuator device is found to be successful, it will help treat thousands if not millions of patients and recover their mobility.

Since this device is designed for implantation, safety is of the highest priority both for animal models and human patients. Before any testing can be done, approval from all major regulatory bodies will be obtained. This device will be first tested on rats and rabbits and ultimately translated to humans if testing produce favorable results. The implantation of this device is designed to minimize damage to the surrounding tissue. Furthermore, the actuation strategy will be minimally invasive compared to other potential solutions.

This project’s device’s mechanical and biocompatibility properties were consistently optimized throughout the fabrication process. If any component of the device causes a biological response, actions will be taken to minimize any negative impact. The parts and materials we used are all biocompatible and designed for implantation. Further testing and research will be conducted on nerve properties to supplement existing knowledge. Once fabricated to optimal performance, testing will be done up to international standards such as ISO 10993-1, where the device would be considered an implant device since it involves tissue/bone contact for a prolonged period of time. Rat and rabbit models will first be used to validate its translation to human testing. This design would be considered a Class III medical device, similar to a replacement heart valve, and due to its similarity to Patent 882.5275 and Patent 888.3020 (which are devices currently on the market), it would enter the market through the 510(k) pathway .

The cost of fabricating the device is very minimal. All aspects of the device are 3D printed, which come out to a few dollars per amount of material used. Since the scale of the device is on the order of millimeters, this amount is very small. The total cost for all aspects of fabricating one device at scale was approximately $35.

Page Leader: Young Sung Moon (Global, Ethical) , Michael Hidayat (Economic) and Olivia Lipco (Health and Safety)

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