SBIR-STTR Award

New technology is needed for the treatment of venous congestion, a serious complication of reconstructive surgery. Currently, live leeches are used, but are psychologically traumatic to patients being treated, and are often ineffective in preventing tissue death. Because there are no other alternatives for treating venous congestion, a mechanical device for this purpose represents a pioneering concept, unique to the current marketplace. The long-term goal of this research is to develop a fully automated, clinically applicable medical device capable of treating venous congestion over an extended time period. The aim of Phase I is to demonstrate feasibility of using a rudimentary device prototype developed in our laboratory to successfully treat venous congestion for a 12-hour period. Congested fasciocutaneous pedicle flaps will be created in 16 pigs, with 8 treatment and 8 control animals. Tissue health during treatment and control experiments will be monitored by quantitative measurements of skin color, surface perfusion, subcutaneous oxygen tension, and blood volume removed. Histological analysis of tissue viability at the end of 12 hours will determine the success of the device in treating venous congestion. A device that effectively treats venous congestion will replace the use of live leeches and will have far-reaching societal benefits. PROPOSED COMMERCIAL APPLICATIONS: The innovative technology developed will completely replace medicinal leeches as the standard treatment for venous congestion, a serious complication of reconstructive surgery.

Thesaurus Terms:
biomedical equipment development, blood coagulation, blood vessel restoration, surgery material /equipment Hirudinea, biomedical automation, blood flow, oxygen tension, revascularization surgery histology, swine

New technology is needed for the treatment of venous congestion, a serious complication of reconstructive surgery. Currently, live leeches are used, but are psychologically traumatic to patients, and are often ineffective in preventing tissue death. Because there are no other alternatives for treating venous congestion, a mechanical device for this purpose represents an innovative concept. The long-term goal of this research is to develop AutoFIow, a fully automated medical device for treating venous congestion. In Phase I, we demonstrated the feasibility of developing and using AutoFIow in a pig model. In Phase II, our aims are: (1) to miniaturize AutoFIow, (2) to reduce the number of bleeding sites required for AutoFIow treatment by increasing bleeding time per applied wound; methods of treating endothelial and interstitial edema will be incorporated for this purpose, and (3) to incorporate blood autotransfusion capability. Crucial refinements in size will expand the use of AutoFIow to tissue configurations not currently supported by our prototype, such as fingers, and to potential use in children. Miniaturization and increased bleeding time per wound will result in decreased potential for tissue damage. By incorporating methods of returning autologous blood to the patient, the blood transfusions frequently required by live leech therapy will be eliminated. Miniaturization, longer wound bleeding times, and autotransfusion will create a large functional divide between use of AutoFIow and medicinal leeches, and will establish AutoFlow as the universally preferred method for the treatment for venous congestion in the marketplace.

Thesaurus Terms:
autotransfusion, biomedical equipment development, blood coagulation, blood vessel restoration, miniature biomedical equipment, surgery material /equipment biomedical automation, blood flow, oxygen tension, revascularization surgery, vein occlusion biotechnology, histology, laboratory rat, swine