Synthetic Substitutes of Surgical Gut Sutures

说明(由申请人提供)：在引入聚乙交酯之前 (PG)作为编织的合成可吸收缝线，外科肠缝(SGS)是 为许多外科手术选择缝合线。尽管PG缝合是一种坚固的 SGS的竞争对手，后者在特定程序中仍然是可取的，因为 其伪单丝形式、结节安全性和吸收轮廓。连 在过去20年里推出了几种单丝缝合技术后， SGS的使用受到轻微影响。这是因为它吸收快。 SGS与所有合成单丝缝合线的比较。然而， 关于牛海绵状脑病(BSE)及其与 SGS的使用及其不良的高组织反应威胁着其临床应用 生存能力。这证明了探索开发一种新的合成材料是合理的 可吸收缝线，显示了SGS的大多数属性，而不会与 其有害的组织反应和患疯牛病的风险。第一阶段的目标是确定 开发一种可吸收的顺应性单丝缝合线的可行性 (1)类似于SGS的处理和打结特性；(2)初始持有 强度优于SGS；以及(3)吸收曲线比SGS快得多 呈现单丝缝合。第一阶段计划需要(1)设计一类新的 基于一种独特形式的预聚体和 候选共聚物的制备/表征，(2)单丝纺丝 选择的共聚物，并评估其体外性能为可吸收 (3)确定了两种最有希望的候选缝线并进行了评价 其体内强度保持谱和组织反应；以及(4) 编制第二阶段计划，其中将包括流程开发和扩大规模 选择缝合线并启动必要的研究以满足FDA的监管要求 要求。 建议的商业应用： 第一阶段的成功完成将(1)为临床研究提供基础数据 在第二阶段中替代外科手术肠道；(2)证明使用的可行性 大分子链设计中的新概念，用于开发新型可吸收材料 已知的和新的应用；以及(3)产生与新的低成本应用相关的新的关键数据。 剂量辐射灭菌和自催化生产可吸收外科植入物和 用于组织工程的支架。

DESCRIPTION (provided by applicant): Prior to introduction of polyglycolide (PG) as braided synthetic absorbable sutures, surgical gut suture (SGS) was the choice suture for many surgical procedures. Although the PG suture was a strong competitor to SGS, the latter remained desirable in specific procedures because of its pseudo-monofilamentous form, knot security, and absorption profile. Even after introducing several monofilament sutures over the past two decades, the use of SGS was slightly affected. This is because of the fast absorption profile of SGS in comparison to all synthetic monofilament sutures. However, new concerns about bovine spongiform encephalopathy (BSE) and its relevance to the use of SGS and its undesirable high tissue reactions threaten its clinical viability. This justified exploring the development of a new synthetic absorbable suture that displays most attributes of SGS without contending with its unwanted tissue reaction and risk of BSE. Phase I objective is to determine feasibility of developing an absorbable, compliant monofilament suture having (1) similar handling and knot properties to SGS; (2) an initial holding strength superior to SGS; and (3) considerably faster absorption profile than present monofilament sutures. Phase I plans entail (1) designing a new class of block copolyesters based on a unique form of prepolymers and preparation/characterization of candidate copolymers, (2) monofilament spinning of selected copolymers and evaluating their in vitro properties as absorbable sutures; (3) identifying two most promising candidate sutures and evaluating their in vivo strength retention profiles and tissue reaction; and (4) preparing Phase II plans, which will include process development and scale-up of a selected suture and initiating needed studies to meet FDA regulatory requirements. PROPOSED COMMERCIAL APPLICATION: Successful completion of Phase I will (1) provide the basic data for development of a clinically equivalent or superior substitute to surgical gut in Phase II; (2) demonstrate the viability of using a novel concept in macromolecular chain design to develop new absorbable materials for known and new applications; and (3) yield new critical data pertinent to the novel use of low- dose radiation sterilization and autocatalysis in producing absorbable surgical implants and scaffolds for tissue engineering.