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单丝可吸收缝线，其在植入后三个月的强度保留率为50%。该产品有望满足缝合市场对可提供长期伤口支持的设备的未满足需求。这种产品可用于治疗糖尿病、免疫系统受损、营养障碍、肥胖或损害伤口愈合的疾病，如恶性肿瘤或感染。该缝线也有望在筋膜闭合和韧带和肌腱修复的骨科手术中得到应用。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（P4HB）。该项目的具体目标是：(1)生产P4HB的可挤压形式；(2)优化P4HB单丝的生产；(3)制备P4HB缝合线；(4)表征P4HB缝合性能；(5)测定P4HB的体内强度保留；(6)建立P4HB强度保持体外模型；(7)评价缝合线的生物相容性；(8)证明P4HB缝线的手术功能；(9)分析P4HB的生物分布和药代动力学；（10）确定缝合稳定性和保质期。除了开发一种有用的新产品外，这项研究还有望帮助引入一种新的医疗生物材料，这种材料有望应用于其他医疗设备，如外科手术网、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.