The overall objective of our collaborative research program is to develop a clinically useful Lower Extremity Transcutaneous (LET) prosthesis. This structural system that can be attached to an amputee's surviving natural bone to provide a direct, load-bearing path through the skin to an external prosthesis. This device would mitigate a severe and frequent morbidity; in 1996 there were 1,285,000 amputees in the US. The most important clinical advance offered by the LET prosthesis is the elimination of the prosthetic socket and the majority of the common problems of the prosthesis user. Thus the LET will contribute substantially to the quality of life of amputees. This SBIR project is intended to demonstrate the feasibility of the enabling technology for the LET: a high performance transcutaneous port (HPTP) that can provide a long term, efficient infection/ bacterial barrier at the skin/ pylon interface. To overcome the limitations of existing transcutaneous ports, we propose a systems approach to engineering the HPTP, with functional requirements for both dermal and epidermal components. Our approach utilizes the tissue-engineering design principles and technology that led to a clinically and commercially successful artificial skin and our research methodology is based on a well-understood animal model that was used to develop the artificial skin. Another innovation is advanced composite technology that provides the ability to design the port to be integrated into a structural load bearing prosthetic pylon. This approach integrates the patient's skin into the prosthetic unit providing a mechanical barrier to bacteria migration in vivo. We expect our approach to enable the development of a long term, efficient infection/ bacterial barrier at the skin interface that will reduce the rate of superficial and deep infection to clinically acceptable levels. Such a permanent transcutaneous access will have many valuable medical applications in addition to the LET.
Thesaurus Terms: artificial limb, artificial skin, biomaterial development /preparation, tissue engineering biomaterial compatibility, quality of life, wound healing bioengineering /biomedical engineering, biotechnology, guinea pig, medical implant science
