The objective of this program is to develop an electrical connector/cable concept applicable to a wide variety of implanted medical devices and ultimately to proceed to commercialization and marketing of an array of connector/cable assemblies. These would be made available to original manufacturers of clinical devices and to institutions engaged in experimental research. In the Phase I program, the concepts' basic design will be optimized, prototype parts built, and in vitro demonstration tests conducted. An existing connector concept which has undergone extensive development by Nimbus will be used as the design basis. This design will be refined through utilization of a unique mechanical capture at the boot/connector seal, further miniaturization of the mechanical elements, adaptation to more conductors, and optimization of the moisture barrier and sealing approaches. Connector/cable assemblies will be fabricated and subjected to mechanical load cycling and salt water bath exposure tests. Completion of Phase I should provide a basis for finalization of the design of a line of connector/cable units. This would be accomplished in Phase II. Additionally, in Phase II, sample units will be fabricated and subjected to an extensive qualification test program involving both in vitro and in vivo methods. With the completion of Phase II, a sufficient data base should exist and the technical merit of the concept fully demonstrated, thus commercialization of a connector/cable product can be pursued. In summary, this program addresses technical problems that are most prevalent in the development and application of implanted electrical devices. The technological innovations resulting from this program should essentially solve these problems.
