Synthetic Substitutes of Surgical Gut Sutures

描述（由申请方提供）：在引入聚乙交酯之前 (PG)作为编织合成可吸收缝线，外科肠线（SGS）是 许多外科手术的首选缝线。尽管PG缝线是一种强力的 SGS的竞争对手，后者在特定程序中仍然是可取的， 其假单丝状形式、结安全性和吸收特征。甚至 在过去二十年中引入了几种单股缝线后， SGS的使用受到轻微影响。这是因为快速吸收 SGS与所有合成单股缝线相比的特征。然而，在这方面， 关于牛海绵状脑病（BSE）的新关注及其与 SGS的使用及其不期望的高组织反应威胁其临床应用， 生存能力。这证明了探索一种新的合成药物的开发是合理的。 可吸收性缝线显示SGS的大多数属性，而不与 它有害的组织反应和疯牛病的风险。第一阶段的目标是确定 开发可吸收的顺应性单丝缝线的可行性， (1)与SGS类似的处理和结属性;（2）初始保持 强度上级于SGS;和（3）吸收曲线比 存在单股缝线。第一阶段计划包括：（1）设计一个新的类别， 基于独特形式的预聚物的嵌段共聚酯， 候选共聚物的制备/表征，（2）单丝纺丝 选择的共聚物，并评价其体外性能， 缝线;（3）确定两种最有希望的候选缝线，并评价 它们的体内强度保持特性和组织反应;以及（4） 编制第二阶段计划，其中将包括工艺开发和扩大规模 选定的缝线，并启动所需的研究，以满足FDA法规要求 要求. 拟定商业应用： 第一阶段的成功完成将（1）为临床开发提供基础数据 II期试验中与外科肠线等同或上级替代品;（2）证明使用 大分子链设计的新概念，以开发新的可吸收材料， 已知的和新的应用;和（3）产生新的关键数据有关的新的使用低- 在生产可吸收外科植入物中的剂量辐射灭菌和自催化， 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.