Synthetic Substitutes of Surgical Gut Sutures

外科肠道缝合线的合成替代品

• 批准号: 6402273
• 负责人: SHALABY W SHALABY
• 金额: $ 10万
• 依托单位: POLY-MED, INC.
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-08-01 至 2002-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6402273
• 关键词: biodegradable product; biomaterial compatibility; biomaterial development /preparation; biomaterial evaluation; copolymer; laboratory rat; physical property; surgery material /equipment; tensile strength

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.

描述（由申请人提供）：在引入聚乙交酯之前 (PG) 作为编织合成可吸收缝合线，外科肠道缝合线 (SGS) 是 许多外科手术的首选缝合线。尽管 PG 缝合线强度很高 SGS 的竞争对手，后者在具体程序中仍然是可取的，因为 其假单丝形式、结安全性和吸收特性。甚至 在过去二十年推出几种单丝缝合线之后， SGS 的使用受到轻微影响。这是因为吸收快 SGS 与所有合成单丝缝合线相比的概况。然而， 关于牛海绵状脑病（BSE）及其相关性的新担忧 SGS 的使用及其不良的高组织反应威胁其临床 生存能力。这证明探索开发新的合成材料是合理的 可吸收缝合线，显示 SGS 的大部分属性，无需与 其不良组织反应和疯牛病风险。第一阶段的目标是确定 开发可吸收、顺应性单丝缝合线的可行性 (1) 与SGS相似的处理和结性能； (2) 初始持股 强度优于SGS； (3) 吸收曲线比 目前采用单丝缝合线。第一阶段计划包括 (1) 设计一类新的 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 选定的共聚物并评估其可吸收的体外特性 缝合线； (3) 确定两种最有希望的候选缝合线并进行评估 它们的体内强度保留曲线和组织反应；和（4） 准备第二阶段计划，其中包括工艺开发和放大 选定的缝合线并启动所需的研究以满足 FDA 监管要求 要求。 拟议的商业应用： 第一阶段的成功完成将（1）为临床开发提供基础数据 II 期手术肠道的同等或更好的替代品； (2) 证明使用的可行性 大分子链设计的新颖概念，用于开发新的可吸收材料 已知的和新的应用程序； (3) 产生与低效新用途相关的新关键数据 生产可吸收外科植入物中的剂量辐射灭菌和自催化 用于组织工程的支架。