Bioswellable Absorbable Monofilament Sutures

生物膨胀可吸收单丝缝合线

• 批准号: 7216652
• 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: 2007
• 资助国家: 美国
• 起止时间: 2007-04-01 至 2007-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7216652
• 关键词: Area; Biological; Blood; Caliber; Characteristics; Chemicals; Condition; Data; Development; Development Plans; Environment; Esters; Evaluation; Exhibits; Extravasation; Fiber; Generations; Hemorrhage; Implant; In Vitro; Infection; Laparoscopic Surgical Procedures; Laparoscopy; Lead; Life; Ligation; Liquid substance; Mechanics; Microsurgery; Needles; Operative Surgical Procedures; Performance; Phase; Phase II Clinical Trials; Polyethylene Glycols; Polymers; Property; Range; Security; Site; Solutions; Sterility; Surgical sutures; System; Tissues; absorption; comparative; concept; copolymer; design; in vivo; monomer; novel; preclinical study; scale up

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.

描述（由申请人提供）：大多数使用外科缝合线对活体组织进行机械结扎都需要线和针的组合。在大多数情况下，针的直径远远超过缝合线的直径，这可能导致体液（包括血液）通过植入缝合线周围的针形成的孔泄漏。根据手术部位的不同，这可能会导致出血和感染。在过去的几十年里，已经进行了一些尝试来最大限度地减少针孔泄漏，但没有临床上最佳的解决方案。这促使我们进行拟议的研究，探索第一代可膨胀缝合线的开发和评估，重点是可吸收单丝类型以及用于腹腔镜检查和显微外科手术的缝合线。因此，第一阶段的目标是合成可吸收的两亲性聚醚酯并评估它们作为生物可溶胀可吸收缝合线的用途。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，以提供最佳的机械性能； (3)非无菌单丝基本缝合性能的体外评价； (4) 选择候选单丝的快速和延迟吸收曲线并完成其体内断裂强度保留； (5)选择两种组合物来生产具有快速和延迟吸收特性的可生物膨胀、顺应性单丝缝合线，用于II期研究。这需要聚合物/缝合线的开发和放大研究以及临床前研究的启动。新型生物膨胀手术缝合线的开发将有助于最大限度地减少或消除手术期间和术后的缝合线和针孔出血/渗漏以及相关的失血和感染。