Bioswellable Absorbable Monofilament Sutures

描述（由申请人提供）：使用外科缝线对活组织进行的大多数机械结扎需要线和针的组合。在大多数情况下，缝针直径远远超过缝线直径，这可能导致体液（包括血液）通过植入缝线周围的缝针产生的孔泄漏。根据手术部位，这可能导致出血和感染。在前几十年中，在没有临床最佳解决方案的情况下，已经进行了一些尝试以最大限度地减少针孔泄漏。这促使进行拟定研究，以探索第一代可膨胀缝线的开发和评价，重点关注可吸收单股缝线类型以及用于腹腔镜和显微外科手术的缝线。因此，I期研究的目的是合成可吸收性两亲性聚醚酯，并对其用作生物可溶胀可吸收缝线进行评价。第一阶段计划包括（1）几种可吸收结晶聚醚酯的合成和表征;（2）在既定条件下将选定的共聚物转化为单丝，以提供最佳机械性能;（3）体外评价非无菌单丝的基本缝线性能;（4）选择用于快速和延迟吸收曲线的候选单丝，并完成其体内断裂强度保持;（5）选择两种组合物以生产具有快速和延迟吸收特征的生物可溶胀的顺应性单丝缝合线用于II期研究。这需要聚合物/缝线开发和规模扩大研究以及临床前研究的启动。新型生物可溶胀外科缝线的开发将有助于最大限度地减少或消除缝合孔和针孔出血/渗漏以及手术期间和手术后的相关失血和感染。

DESCRIPTION (provided by applicant): Most mechanical ligations of living tissues using surgical sutures require a combination of a thread and needle combination. In most cases, the needle diameter far exceeds that of the suture, which can result in leakage of bodily fluids, including blood, through needle-created holes about implanted suture thread. Depending on the surgical site, this can lead to bleeding and infection. A few attempts have been made in earlier decades to minimize needle hole leakage without a clinically optimum solution. This prompted the pursuit of the proposed study to explore development and evaluation of a first generation of swellable sutures with a focus on the absorbable monofilament type and those for use in laparoscopy and microsurgery. Accordingly, Phase I objective is synthesis of absorbable amphiphilic polyether esters and their evaluation for use as bioswellable absorbable sutures. And Phase I plans entail (1) synthesis and characterization of several absorbable crystalline polyether esters; (2) conversion of selected copolymers to monofilaments under established conditions to provide optimum mechanical properties; (3) in vitro evaluation of non-sterile monofilaments for basic suture properties; (4) selection of candidate monofilaments for fast and delayed absorption profiles and completion of their in vivo breaking strength retention; (5) selection of two compositions to produce bioswellable, compliant monofilament sutures having fast and delayed absorption profiles for Phase II study. This entails polymer/suture development and scale-up studies and initiation of preclinical studies. Development of novel bioswellable surgical sutures will help minimize or eliminate suture- and needle-hole bleeding/leakage and associated blood loss and infection during and after surgery.