The main objective of the proposed Phase I SBIR grant is to foster the development of novel nanostructured bioabsorbable membranes for medical applications. An innovative electrospinning technology has been applied successfully for the fabrication of these unique membranes based on FDA-approved polyglycolide and polylactide bioabsorbable polymers. Our membranes offer several distinct advantages over the existing commercial products, such as INTERCEED* and SepraFilm*. The electrospinning processing technique can: (i) control diameters of the fibers over a very broad size range from about 10 - 1000 nanometers, (ii) design textures and porosity of the nonwoven structures with controlled thickness of the membrane, and (iii) introduce medications, such as antibiotics and enzyme inhibitors, into the membrane without chemical decomposition. The degradation rate of the membrane, the drug release rate, and the handling capability of the film, such as stickiness and flexibility, can be tuned by varying the fiber diameter, texture, porosity and membrane thickness. In preliminary animal (rat) studies, our membrane shave shown to have better performance in terms of anti-adhesion with fewer scars. There are many potential applications of these membranes in the clinical arena, including the prevention of intestinal obstruction in the abdomen after abdominal surgery and adhesion problems related to female patients after open gynecologic pelvic procedures. In addition, patients undergoing cardiac or thoracic surgery may benefit, owing to the increasing rate of re-operative cardiac surgical procedures. Adhesions increase the morbidity of re-operative cardiac surgery. In the phase I studies, we plan to investigate quantitative relationships between the processing parameters in electrospinning, together with variations on the fabrication process, in order to fine tune the rate of degradation of the membrane and the release rate of medications for the specific applications in pelvic surgery. The animal tests will be in preparation for test on human subjects in phase II.
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| Liang, Dehai; Hsiao, Benjamin S; Chu, Benjamin (2007) Functional electrospun nanofibrous scaffolds for biomedical applications. Adv Drug Deliv Rev 59:1392-412 |
