A new absorbable mesh for hernia repair

描述（由申请人提供）：本研究旨在确定开发一种用于疝修补的新型可吸收补片（具有长期强度保留）的可行性。该产品预计将在当前合成不可吸收补片结局较差的情况下应用，例如植入受污染的手术野，或植入可能阻碍生长的儿科患者。还希望该产品能够减少并发症的发生，如瘘形成、疼痛和疝修补术后的身体能力限制。如果证明这种新补片上级现有选项，则可以从这种新补片中受益的患者总数很大。每年大约进行150万例腹股沟疝修补手术和20万例腹疝手术。该研究方法将采用一种新的可吸收生物材料，称为聚-4-羟基丁酸酯（也称为PHA 4400），与现有的可吸收缝线生物材料相比，该材料已被证明具有延长的体内强度保留。该项目的具体目标是：（1）生产可熔融挤出级PHA 4400;（2）挤出适用于编织成疝补片的PHA 4400单丝纤维;（3）制备拉伸强度与市售合成材料相当的PHA 4400单丝编织补片。（聚丙烯）疝补片;和（4）证明使用PHA 4400补片进行疝修补术在3个月时的体内机械稳定性大于现有可吸收补片（Vicryl TM），与不可吸收聚丙烯补片的性能进行初步比较，并对植入研究的样本进行形态学和组织学研究，以评估组织反应。除了开发一种可以改善疝修补手术结果的产品外，该研究还将有助于将一种新的可吸收医用生物材料引入医学界，该材料可以在控释，组织工程和其他设备中找到其他用途。

DESCRIPTION (provided by applicant): The objective of this research is to determine the feasibility of developing a new absorbable mesh with prolonged strength retention for hernia repair. The product is expected to find application where current synthetic non-absorbable meshes provide poor outcomes, such as implantation in contaminated surgical fields, or in pediatric patients where they can hinder growth. It is also hoped that the product will lead to less occurrence of complications such as fistula formation, pain, and restriction of physical capabilities that can follow hernia repair procedures. The total number of patients that could benefit from this new mesh is large if it proves to be superior to existing options. Approximately, 1.5 million inguinal hernia repair procedures and 200,000 ventral hernia procedures are performed each year. The research approach will employ a new absorbable biomaterial, known as poly-4-hydroxybutyrate (also known as PHA4400), that has been shown to have prolonged strength retention in vivo compared to existing absorbable suture biomaterials. The specific aims of the project are to: (1) produce a melt extrudable grade of PHA4400; (2) extrude monofilament fiber of PHA4400 suitable for knitting into a hernia mesh; (3) prepare a monofilament knitted mesh of PHA4400 with a tensile strength comparable to commercial synthetic (polypropylene) hernia meshes; and (4) demonstrate that the in vivo mechanical stability of a hernia repair with a PHA4400 mesh at 3 months is greater than with an existing absorbable mesh (Vicryl TM) of comparable weight and density, make a preliminary comparison with the performance of a non-absorbable polypropylene mesh, and perform a morphological and histological study on samples from the implantation study to assess tissue reaction. In addition to developing a product that could improve surgical outcomes of hernia repair procedures, the research will also help to introduce a new absorbable medical biomaterial into the medical community that could find other uses, for example, in controlled release, tissue engineering, and other devices.