Wound closures sometimes fail because tissues lack the organized connective tissue required by sutures and staples. In 2004, we assessed feasibility (Phase I) of FiberSecure; a coupling fundamentally different from conventional closures: holding is by shear, not direct or normal force. We showed, in that study and others (orthopedic and cardiac power uses), that this coupling of thousands of fine polyester fibers, inserted as bundles are rapidly ingrown by solid tissue. Holding strength reaches theoretical limits i.e., tissue strength itself. It is the mechanism by which root fibrils of plants hold fiercely even in soft soil. These trials have shown, to high probability (p<0.002 in this Phase I), stronger holding than control closures meticulously applied. There are 4 specific aims: (1) Validate healing stability in 12-month implantation begun at funding so any late changes are recognized and addressed (2) Select final design by randomized block study of 2 plausibly useful variations, from histology, histochemistry, and strength, (3) Adapt that design to regulatory (GMP) standards through a manufacturing process with a widely experienced commercial partner, and (4) Study those GMP products for 180 days in a GLP (Good Laboratory Practices) certified facility. Testing uses an abdominal muscle model in Sinclair Miniature Swine. Achieving these 4 aims would result in devices for clinical use under a investigational protocol as the basis for an FDA submission. 510(k) regulations apply. Human and commercial benefit would be enormous. While conventional couplings work quite well for strong tissues, many couplings are in tissues where they too often fail. Mortality and disability follow, across many surgical disciplines, from dehiscence (bursting apart or splitting open) of a sutured abdominal wound, to peripartum uterine rupture after fibroid myotomy or prior cesarean, to unsuccessful repairs of diverse tissues after blunt trauma, to disrupted heart valve replacements in normal (unscarred) annuli. Each may be lethal. This is a device that can address that need. This work is pivotal to its realization. ? ? ?
| Melvin, Alan J; Melvin, David B; Kitzmiller, William J et al. (2011) A soft-tissue coupling for wound closure. J Biomed Mater Res B Appl Biomater 97:184-9 |
