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(申请人提供)：大多数使用外科缝合的活体组织的机械结扎需要线和针的组合。在大多数情况下，针的直径远远超过缝合线的直径，这可能会导致体液(包括血液)通过植入缝合线的针孔泄漏。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，在没有临床最佳解决方案的情况下，人们已经进行了一些尝试，以将针孔渗漏降到最低。这促使了这项拟议的研究，以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和用于腹腔镜和显微外科的缝合线。因此，第一阶段的目标是合成可吸收的两亲性聚醚酯，并评价其作为生物可膨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)对非无菌单丝的基本缝合性能进行体外评估；(4)选择用于快速和延迟吸收曲线的候选单丝，并完成其在体内的断裂强度保持；(5)选择两种组合物，以生产具有快速和延迟吸收曲线的生物可膨胀、顺应性单丝缝合线，用于第二阶段研究。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。新型生物可膨胀外科缝合线的开发将有助于最大限度地减少或消除缝合和针孔出血/渗漏以及手术中和术后相关的失血和感染。