Bioswellable Absorbable Monofilament Sutures

I期研究旨在证明应用大分子链设计的新概念来开发新颖的、合成的、可生物膨胀的、可吸收的、柔顺的、涂覆的和未涂覆的单丝缝合线的可行性。实际上，第一阶段和后一阶段的研究结果表明，使用两亲性的、分段的聚醚酯来设计大分子链的概念可行性，该大分子链由聚乙二醇或末端接枝的环单体组成，以生产两种主要类型的纤维形成共聚物，当被评估为单丝缝合线时，它们具有明显不同的吸收范围和断裂强度保持（BSR）剖面。更具体地说，第一种类型由聚醚酯组成，包括高乙醇酸基序列（usg型），各自的单丝和编织多丝表现出短暂的BSR曲线，在不到三个月的时间内完全失重。与此同时，第二种类型由含有高l-乳酸基序列的聚醚酯（usl型）组成，与usg型相比，各自的单丝具有相对较长的BSR和质量损失曲线。USG和USL类型中的一种被选为第二阶段开发的可行候选物。因此，第二阶段的目标是开发两种特定类型的可膨胀单丝缝线，一种主要用于整形和泌尿生殖器手术的相对快速吸收的usg型缝线，以及一种用于一般和血管手术的缓慢吸收的usl型缝线，并确定将可膨胀单丝技术扩展到多丝医疗结构开发中的优点。II期计划包括(1)完成选定USG和USL聚合物的开发和优化研究以及相关的工艺验证；(2)对单丝生产和涂覆工艺进行优化和验证；(3)完成两种缝线不同尺寸的非glp综合体外和体内研究；(4)启动规模化、安全性和稳定性研究；(5)寻找营销合作伙伴，与Poly-Med合作规划III期研究；(6)完成选定的多丝编织缝合线的重点体外和/或体内研究。公共卫生相关性：开发新型的、可吸收的、生物可膨胀的手术缝合线，这些缝合线与软组织具有生物力学相容性，将有助于减少或消除手术期间和手术后缝合线和针孔出血/渗漏以及相关的失血和感染。

DESCRIPTION (provided by applicant): 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. PUBLIC HEALTH RELEVANCE: 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.