A New Surgical Mesh for Pelvic Floor Reconstruction

描述（由申请方提供）：本研究的目的是确定开发一种用于盆底重建的新型可吸收外科补片的可行性。该产品预计可降低合成不可吸收补片产品发生的侵蚀、挤出和感染的发生率，并且比同种异体移植物和异种移植物假体更便宜。该新设备预计将满足美国200，000例盆腔脱垂手术的市场需求，预计该新产品可以帮助减少需要重复脱垂手术的女性数量（目前为30%）。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。本项目的具体目标是：（1）制备一批适合加工成PHA 4400纱线的PHA 4400;（2）将PHA 4400挤出成合适的纱线，并将其转化为适合用于盆底重建的编织补片;（3）对编织补片进行体外和体内评估，以确定其生物相容性;和（4）证明使用PHA 4400编织补片进行疝修补术在3个月时的体内机械稳定性至少与用于盆底重建的现有替代品相当，并进行形态学和组织学研究，以评估组织反应和PHA 4400补片用于盆底重建的适用性。除了开发一种可以改善盆腔脱垂手术结果的产品外，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，组织工程和其他医疗器械中找到其他用途。

DESCRIPTION (provided by applicant): The objective of this research is to determine the feasibility of developing a new absorbable surgical mesh for pelvic floor reconstruction. The product is expected to reduce the incidences of erosion, extrusion, and infection that occur with synthetic non-absorbable mesh products, and be less expensive than allograft and xenograft prosthetics. The new device is expected to address a market of 200,000 pelvic prolapse procedures in the United States, and it is anticipated that this new product could help reduce the unacceptable number of women (currently 30%) requiring repeat prolapse surgery. The research approach will employ a new absorbable biomaterial, know as poly-4-hydroxybutyrate (also known as PHA4400), that has been show to have prolonged strength retention in vivo compared to existing absorbable suture biomaterials. The specific aims of the project are to: (1) prepare a batch of PHA4400 suitable for processing into PHA4400 yarn; (2) extrude PHA4400 into suitable yarn, and convert it into a knitted mesh suitable for use in pelvic floor reconstruction; (3) undertake an in vitro and in vivo assessment of the knitted mesh to determine its biocompatibility; and (4) demonstrate that the in vivo mechanical stability of a hernia repair with the PHA4400 knitted mesh at 3 months is at least comparable with an existing substitute used in pelvic floor reconstruction, and perform a morphological and histological study to assess tissue reaction and suitability of the PHA4400 mesh for use in pelvic floor reconstruction. In addition to developing a product that could improve surgical outcomes of pelvic prolapse 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 medical devices.