Bioswellable Absorbable Monofilament Sutures Abstract Phase I study was intended and did demonstrate the feasibility of applying a new concept in macromolecular chain design to develop novel, synthetic, bioswellable, absorbable, compliant, coated and uncoated monofilament sutures. In effect, results of Phase I and post-Phase I studies demonstrated the conceptual viability of using amphiphilic, segmented, polyether-esters for designing macromolecular chains comprising polyethylene glycol or (polyethylene glycol-ran-propylene glycol) end-grafted with cyclic monomers to produce two major types of fiber-forming copolymers having distinctly different ranges of absorption and breaking strength retention (BSR) profiles when evaluated as monofilament sutures. More specifically, the first type consists of polyether-esters comprising high glycolide-based sequences (USG-type) and the respective monofilaments and braided multifilaments exhibit brief BSR profiles and a complete mass loss in less than three months. Meanwhile, the second type consists of polyether-esters comprising high l-lactide-based sequences (USL-type) and the respective monofilaments exhibit relatively prolonged BSR and mass loss profiles compared to those of the USG-type. One of the USG and USL types are selected as viable candidates for development in Phase II. Hence, Phase II objective is to develop two specific types of swellable monofilament sutures, a relatively fast-absorbing USG-type suture for use primarily in plastic and urinogenital surgeries, and slow-absorbing USL-type sutures for application in general and vascular surgeries, and define the merits of extending the swellable monofilament technology to the development of multifilament medical constructs. And Phase II plans entail (1) completing the development and optimization studies of the selected USG and USL polymers and associated process validation;(2) optimizing and validating the processes for monofilament production and coating;(3) completing non-GLP comprehensive in vitro and in vivo studies on different sizes of both suture types;(4) initiating the scale-up, safety, and stability studies;(5) securing a marketing partner to collaborate with Poly-Med in planning Phase III study;and (6) completing focused in vitro and/or in vivo studies on selected multifilament braided sutures.
Development of novel, absorbable, bioswellable surgical sutures, which are biomechanically compatible with soft tissue, will help minimize or eliminate suture- and needle-hole bleeding/leakage and associated blood loss and infection during and after surgery.
