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可吸收的疝气网片，该网片优于现有产品，并可通过FDA的S 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状物与现有产品相比将具有几个关键优势，市场上朝着更轻、更灵活和部分可吸收网状物的趋势清楚地表明了这一点。网眼的可吸收能力将减少晚期瘘管、感染和可能的组织粘连的风险。纤维的更大弹性将降低网眼硬度，最终吸收将降低由此产生的组织修复的硬度。该产品有望在目前合成的不可吸收网状物效果不佳的情况下得到进一步应用，例如植入受污染的外科领域，或在可能阻碍生长的儿科患者中。如果事实证明它优于现有的选择，那么可以从这种新的网格中受益的患者总数是很大的。每年大约有150万例腹股沟疝修补术和20万例腹股沟疝修补术。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PHA4400)，已被证明与现有的可吸收缝合生物材料相比，在体内具有更长的强度保持时间。该项目的具体目标是：(1)制备三种结构的PHA4400网片，其初始破裂强度与商业合成(聚丙烯)疝气网片相当；(2)在用于疝修补术的动物模型中评估新的网片结构，并为进一步的开发选择最合适的网片；(3)评估成品装置的生物相容性；(4)开发表征成品装置的拉伸强度、缝合拔出强度、破裂强度和抗撕裂性能的方法；(5)在长期的动物植入研究中确定网片的降解情况；(6)在动物模型中评估用于疝修补术的网片的外科功能；(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，如果时间允许，我们还计划(A)评估网状物抵抗粘连的能力，和(B)评估这种网状物在受污染的外科领域中的有效性和/或确定在感染环境中的配伍性。除了开发一种可以改善疝修补术手术结果的产品外，这项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，这种材料可能会发现其他用途，例如，在控制释放、组织工程和其他设备中。本项目的目标是利用一种新型的可吸收生物材料来开发一种新的改良型腹股沟补片。预计该产品可以减少由目前的疝修补术引起的并发症的发生率。如果该产品被证明比现有的疝网更好，那么大量患者可能会受益，因为每年有超过150万患者接受疝修补术。

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' s 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.