The objective of this research is to establish the feasibility of the design and fabrication of a molded nerve cuff and a complimentary applicator. This product set will be targeted initially at animal researchers who have been using spiral cuff electrodes. Once Phase I is complete and the prototypes.are validated, as one example of an application we will integrate the molded cuff electrode with additional components that can deliver a high frequency nerve conduction block suitable for clinical use. The primary benefit of the spiral cuff electrode has been its ability to adapt to variations in size of the nerve on which it is placed while still maintaining good and stable electrical contact with the nerve. The molded cuff electrode, as described in the application, maintains this self-sizing ability but improves on many other features. In addition, it will be significantly less expensive to manufacture and demonstrate less variability in its mechanical characteristics. The first specific aim is to prototype the molded cuff electrode and test it for mechanical characteristics. We will perform the same tests on the spiral cuff electrode and demonstrate equivalence or superiority of the new design. Based on this experience, the second aim is to develop a set of manufacturing metrics that, if met, would enhance the commercial viability of the device. Finally, we will test the applicator under simulated conditions to verify that the molded cuff electrode system can reliably and consistently be applied with a minimum of wasted time.
