SBIR-STTR Award

This study is designed to develop and evaluate a method of replacing a hollow viscus with a prosthesis that allows primary mucosal healing and incorporation of the prosthetic into the healing process.Healing of a full thickness isolated bowel segment to 2 types of a hollow viscus prothesis will be evaluated in dogs. Both types of prosthesis will consist of an outer rigid mesh and a biodegradable middle layer. The Type A prosthesis will have an inner impervious layer, the Type B prosthesis will not. The prostheses will be evaluated at various postimplantation times of up to and including 60 days. Evaluation of healing patterns of the prostheses and mucosal regeneration, infection, connective tissue ingrowth, rejection, and stricture will be performed by gross exam and light microscopy.

Thesaurus Terms:
Biomaterials, Biomaterials Evaluation, Biomaterials, Development And Preparation Of Biomaterials, Gastrointestinal Prosthesis, Prosthesis Biomaterials, Biomaterials, Interfacial Phenomena, Biomaterials, Tissue Supporting Frames, Fibrous Proteins, Collagen, Gastrointestinal Surgery, Intestinal Surgery, Gastrointestinal System, Intestines, Mucosa, Injuries, Wound Healing, Metabolism, Biotransformation, Plastics, Polyurethanes, Plastics, Silicone Rubber, Prosthesis Implants And Compatibility Histology (General), Mammals, Carnivores, Dogs, Optics, Microscopy (General), Optics, Microscopy, Electron National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

The Phase I study demonstrated that a compound tracheal prosthesis consisting of a rigid outer layer and an inner biodegradable layer can successfully replace 7.5 cm of cervical trachea in the dog without infection, rejection, or extrusion. The prothesis permitted intraluminal epithelization by growth and migration and by free operative buccal mucosa grafts.The Phase II study will continue to evaluate a rigid compound tracheal prosthesis as a replacement for 4-6 cm of cervical trachea. A second stud will evaluate a rigid compound tracheal patch to widen the tracheal and sub-glottic lumen in lambs raised to maturity. A third study will develop and evaluate a flexible compound tracheal prosthesis to replace up to 10 c of thoracic trachea.Methods to increase the rate of epithelization of the prosthetic lumen using incorporation of growth factors, extracellular basement membrane matrix on the inner layer, free operative buccal mucosal grafts, and in-vitro preoperative tissue culture grafting will be evaluated.

Thesaurus Terms:
Animals, Chordates, Mammals, Carnivores, Dogs Biomaterials, Biomaterials Evaluation Cell Growth Regulation Histopathology Injuries, Wound Healing Membrane, Basement Membrane Oral-Pharyngeal, Mucosa Prosthesis Implants And Compatibility Respiratory System, Epithelium Respiratory System, Trachea Respiratory System Prosthesis Tissue (Cell) Culture Tissue Compatibility-Transplant, IsoalloimmunityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)