Bioswellable Absorbable Monofilament Sutures

生物膨胀可吸收单丝缝合线

• 批准号: 7922624
• 负责人: SHALABY W SHALABY
• 金额: $ 33.94万
• 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 2011-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7922624
• 关键词: Animal Model; Base Sequence; Blood Vessels; Characteristics; Data; Development; Esters; Evaluation; Exhibits; Extravasation; Family suidae; Fiber; Filament; Hemorrhage; In Vitro; Infection; Marketing; Medical; Needles; Operative Surgical Procedures; Phase; Plastics; Polyethylene Glycols; Polymers; Process; Production; Property; Propylene Glycols; Rattus; Running; Safety; Secure; Skin; Surgical sutures; Swelling; Technology; Tissues; Triclosan; Validation; absorption; abstracting; antimicrobial; antimicrobial drug; clinically relevant; comparative; copolymer; design; improved; in vitro testing; in vivo; monomer; novel; phase 1 study; phase 3 study; programs; public health relevance; response; scale up; soft tissue

DESCRIPTION (provided by applicant): Bioswellable Absorbable Monofilament Sutures Abstract Phase I study was intended and did demonstrate the feasibility of applying a new concept in macromolecular chain design to develop novel, synthetic, bioswellable, absorbable, compliant, coated and uncoated monofilament sutures. In effect, results of Phase I and post-Phase I studies demonstrated the conceptual viability of using amphiphilic, segmented, polyether-esters for designing macromolecular chains comprising polyethylene glycol or (polyethylene glycol-ran-propylene glycol) end-grafted with cyclic monomers to produce two major types of fiber-forming copolymers having distinctly different ranges of absorption and breaking strength retention (BSR) profiles when evaluated as monofilament sutures. More specifically, the first type consists of polyether-esters comprising high glycolide-based sequences (USG-type) and the respective monofilaments and braided multifilaments exhibit brief BSR profiles and a complete mass loss in less than three months. Meanwhile, the second type consists of polyether-esters comprising high l-lactide-based sequences (USL-type) and the respective monofilaments exhibit relatively prolonged BSR and mass loss profiles compared to those of the USG-type. One of the USG and USL types are selected as viable candidates for development in Phase II. Hence, Phase II objective is to develop two specific types of swellable monofilament sutures, a relatively fast-absorbing USG-type suture for use primarily in plastic and urinogenital surgeries, and slow-absorbing USL-type sutures for application in general and vascular surgeries, and define the merits of extending the swellable monofilament technology to the development of multifilament medical constructs. And Phase II plans entail (1) completing the development and optimization studies of the selected USG and USL polymers and associated process validation; (2) optimizing and validating the processes for monofilament production and coating; (3) completing non-GLP comprehensive in vitro and in vivo studies on different sizes of both suture types; (4) initiating the scale-up, safety, and stability studies; (5) securing a marketing partner to collaborate with Poly-Med in planning Phase III study; and (6) completing focused in vitro and/or in vivo studies on selected multifilament braided sutures. PUBLIC HEALTH RELEVANCE: Development of novel, absorbable, bioswellable surgical sutures, which are biomechanically compatible with soft tissue, 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）：生物可溶胀可吸收单丝缝合线 摘要第一阶段研究旨在证明应用大分子链设计新概念来开发新型合成的、生物可溶胀的、可吸收的、顺应性的、涂层和无涂层单丝缝合线的可行性。实际上，第一阶段和第一阶段后研究的结果证明了使用两亲性、链段聚醚酯来设计包含末端接枝有环状单体的聚乙二醇或（聚乙二醇-无规-丙二醇）的大分子链的概念可行性。生产两种主要类型的成纤共聚物，当作为单丝缝合线进行评估时，它们具有明显不同的吸收范围和断裂强度保留（BSR）曲线。更具体地，第一类型由包含高乙交酯基序列的聚醚酯（USG型）组成，并且各自的单丝和编织复丝表现出短暂的BSR曲线和在不到三个月内完全的质量损失。同时，第二种类型由包含高L-丙交酯基序列的聚醚酯（USL型）组成，并且与USG型相比，相应的单丝表现出相对较长的BSR和质量损失曲线。 USG 和 USL 类型之一被选为第二阶段开发的可行候选者。因此，第二阶段的目标是开发两种特定类型的可膨胀单丝缝合线，一种主要用于整形和泌尿生殖外科手术的相对快速吸收的USG型缝合线，以及用于普通和血管手术的缓慢吸收的USL型缝合线，并确定将可膨胀单丝技术扩展到多丝医疗结构开发的优点。第二阶段计划包括（1）完成所选 USG 和 USL 聚合物的开发和优化研究以及相关工艺验证； (2) 优化和验证单丝生产和涂层工艺； (3) 完成两种缝合线不同尺寸的非GLP综合体外和体内研究； (4) 启动放大、安全性和稳定性研究； (5) 确保营销合作伙伴与 Poly-Med 合作规划 III 期研究； (6) 完成对选定的多丝编织缝合线的集中体外和/或体内研究。公共健康相关性：开发新型、可吸收、可生物膨胀的手术缝合线，其在生物力学上与软组织相容，将有助于最大限度地减少或消除缝合线和针孔出血/渗漏以及手术期间和术后相关的失血和感染。