A New Surgical Mesh for Pelvic Floor Reconstruction

描述（由申请人提供）：本研究的目的是确定开发一种用于骨盆底重建的新型可吸收外科补片的可行性。该产品有望减少合成不可吸收网片产品发生的侵蚀、挤压和感染的发生率，并且比同种异体和异种移植义肢更便宜。这种新设备有望满足美国20万例骨盆脱垂手术的市场需求，预计这种新产品可以帮助减少需要重复脱垂手术的女性人数（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PHA4400），与现有的可吸收缝合生物材料相比，该材料已被证明在体内具有较长的强度保留。该项目的具体目标是：(1)制备一批适合加工成PHA4400纱的PHA4400；(2)将PHA4400挤出成合适的纱线，转化成适合用于盆底重建的针织网；(3)对编织网进行体内和体外评估，确定其生物相容性；(4)证明使用PHA4400针织补片修补疝3个月的体内机械稳定性至少与现有用于盆底重建的替代品相当，并进行形态学和组织学研究，评估组织反应和PHA4400补片用于盆底重建的适用性。除了开发一种可以改善骨盆脱垂手术结果的产品；这项研究还将有助于将一种新的可吸收医学生物材料引入医学界，这种材料可以找到其他用途，例如在控释、组织工程和其他医疗设备中。

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.