A new absorbable mesh for hernia repair

描述（由申请人提供）：该项目的目标是开发一种优于现有产品的可吸收疝补片，并可通过FDA的510k上市前通知程序获得批准。由Tepha的PHA4400生物材料制成的可吸收网将比现有产品具有几个关键优势，并且市场趋势清楚地表明，更轻、更灵活和部分可吸收的网。网状物的可吸收性将减少晚期瘘管、感染和可能的组织粘连的风险。纤维更大的柔韧性会降低网状物的刚度，最终的吸收会降低组织修复的刚度。该产品预计将进一步应用于目前合成的不可吸收网提供较差的结果，例如植入受污染的手术区域，或在儿科患者中，它们可能阻碍生长。如果证明这种新补片优于现有的选择，那么受益于这种补片的患者总数将会很大。每年大约有150万例腹股沟疝修补手术和20万例腹疝手术。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，该材料已被证明具有较长的体内强度保留。该项目的具体目标是：(1)制备三种配置的PHA4400网，其初始破裂强度与商用合成（聚丙烯）疝网相当；(2)在疝修补动物模型中评估新的补片配置，选择最合适的补片进行进一步开发；(3)评价制剂的生物相容性；(4)制定成品装置的抗拉强度、缝合拉出强度、破裂强度和抗撕裂性的表征方法；(5)在长期的动物植入研究中确定网状物的降解特征；(6)在动物模型中评估补片修补疝的手术功能；(7)在一年的加速老化研究中评估产品和包装的稳定性。除了FDA的具体要求外，如果时间允许，我们还计划(a)评估补片抗粘连的能力，以及(b)评估该补片在受污染手术领域的效用和/或确定感染环境下相容性的潜力。除了开发一种可以改善疝气修复手术效果的产品外，这项研究还将有助于向医学界引入一种新的可吸收医学生物材料，这种材料可以在控释、组织工程和其他设备中找到其他用途。本项目的目的是利用一种新型可吸收生物材料开发一种新的改进疝补片。预计该产品可以减少目前疝气修补手术引起的并发症的发生率。如果该产品被证明比现有的疝补片更好，那么大量患者将受益于该产品，因为每年有超过150万患者接受疝修补手术。

DESCRIPTION (provided by applicant): The goal of this project is to develop an absorbable hernia mesh that is superior to existing products and can be cleared through the FDA' 510k premarket notification process. An absorbable mesh made of Tepha's PHA4400 biomaterial would have several key advantages over existing products and is clearly indicated by the trend in the market place towards lighter, more flexible and partially absorbable meshes. The absorbability of the mesh would reduce late term fistula and risk of infection and possibly tissue adhesions. Greater flexibility of the fiber will reduce mesh stiffness and eventual absorption will reduce the stiffness of the resulting tissue repair. The product is expected to find further 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. 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) prepare three configurations of a PHA4400 mesh with an initial burst strength comparable to commercial synthetic (polypropylene) hernia meshes; (2) evaluate the new mesh configurations in an animal model for hernia repair and select the most appropriate mesh for further development; (3) evaluate the biocompatibility of the finished device; (4) develop methods to characterize the finished device for tensile strength, suture pullout strength, burst strength and tear resistance; (5) determine the degradation profile for the mesh in a long- term animal implantation study; (6) evaluate the surgical functionality of the mesh for hernia repair in an animal model; (7) evaluate the stability of the product and package in a one-year accelerated aging study. In addition to the FDA's specific requirements, if time allows, we also plan to (a) evaluate the ability of the mesh to resist adhesions, and (b) evaluate the utility of this mesh in a contaminated surgical field and/or determine the potential for compatibility in a setting of infection. 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. The objective of this project is to develop a new improved hernia mesh using a novel absorbable biomaterial. It is anticipated that the product could reduce the incidence of complications resulting from current hernia repair procedures. A large number of patients could benefit from this product if it proves to be better than existing hernia meshes as more than 1.5 million patients undergo hernia repair procedures each year.