Biopolymer Fiber as a Bioabsorbable Monofilament Suture

描述（由申请人提供）：本研究的目的是开发一种植入三个月后强度保留50%的单股可吸收缝线。预期该产品可满足缝线市场中对可提供长期伤口支持的器械的未满足需求。这样的产品可用于治疗患有糖尿病、免疫系统受损、营养障碍、肥胖或损害伤口愈合的病症（例如恶性肿瘤或感染）的患者。该缝线还有望应用于筋膜闭合以及韧带和肌腱修复的骨科手术。该方法涉及使用一种新的专有可吸收生物材料，称为聚-4-羟基丁酸酯（P4 HB）。该项目的具体目标是：（1）生产可挤出形式的P4 HB;（2）优化P4 HB单丝的生产;（3）制备P4 HB缝线;（4）表征P4 HB缝线的性能;（5）确定P4 HB的体内强度保持率;（6）开发P4 HB强度保持率的体外模型;（7）评价缝线的生物相容性;（8）证明P4 HB缝线的手术功能;（9）分析P4 HB的生物分布和药代动力学;（10）确定缝线稳定性和有效期。除了开发一种有用的新产品外，该研究还有望有助于引入一种新的医用生物材料，该材料有望应用于其他医疗器械，如外科补片、组织工程支架和药物释放基质。

DESCRIPTION (provided by applicant): The objective of this research is to develop a monofilament absorbable suture with a 50% retention of strength three months after implantation. This product is expected to meet an unmet need in the suture market for a device that can provide longer term wound support. Such a product could be used in the treatment of patients with diabetes, compromised immune systems, nutritional impairment, obesity, or conditions that compromise wound healing such as malignancy or infection. The suture is also expected to find application in fascia closure, and in orthopedic procedures for ligament and tendon repair. The approach involves the use of a new proprietary absorbable biomaterial known as poly-4-hydroxybutyrate (P4HB). The specific aims of the project are to: (1) produce an extrudable form of P4HB; (2) optimize the production of a monofilament of P4HB; (3) prepare sutures of P4HB; (4) characterize the P4HB suture properties; (5) determine the in vivo strength retention of P4HB; (6) develop an in vitro model for P4HB strength retention; (7) evaluate the suture's biocompatibility; (8) demonstrate the surgical functionality of the P4HB suture; (9) analyze the biodistribution and pharmacokinetics of P4HB; and (10) determine the suture stability and shelf life. In addition to developing a useful new product, the research is also expected to assist in the introduction of a new medical biomaterial that is expected to have application in other medical devices, such as surgical meshes, tissue engineering scaffolds and drug release matrices.