A Biosynthetic Degradable Textile for Soft Tissue Reconstruction

摘要 剖腹手术患者中有高达30%的患者腹股沟的发生和复发。腹股沟疝气 发生和复发是由于永久性和可降解网片的锚点失效(即 缝合、大头钉和螺丝穿过网眼和组织，导致网眼迁移和/或 收缩)。简单地说，当网片没有充分固定在组织上并迁移或转移时，就会发生或复发疝气 合同。中到重的网眼很少会裂开，从而导致疝气穿透撕裂的网眼。 或在完整的网状锚点之间发生疝气。生物合成疝气网片(即合成疝气 由可生物降解的聚合物制成的网片)是疝气网片市场中增长最快的细分市场 2017年销售额约为9500万美元。此外，最近几次长期发生(预防)和复发 (治疗)结果研究表明，较新的可降解生物合成网状物，包括Bio-A， PhaSix和TIGR Mesh促进组织再生，在性能和安全性上与 永久性网状物，优于异种和同种异体移植物。然而，尽管出现了支持 永久性网状物上的生物合成网状物和市场上生物合成网状物的逐渐增长， 生物合成网状物与永久性网状物有相同的发生和复发问题--两者都 不同类型的网眼缺乏足够的软组织锚定系统。而锚点故障无疑已经 几十年来一直被认为是腹股沟腹股沟复发的最常见原因，目前还没有 市场上的锚定系统就是为解决这一问题而设计的。缝合线(或大头针、螺丝钉或胶水) 仅仅是不够。迫切需要一个更好的锚定系统。为了满足这一需求，深蓝医疗 Advance，Inc.(DBMA)设计了一种获得专利的T-Line®疝气网片锚定系统，用于开放式和 并演示了使用永久性聚丙烯网片的好处。DBMA有 成功完成第一阶段目标选择具有适当机械性能的可生物降解共聚物 性能和降解率，以促进愈合。新颖的生物合成T型线疝气网片设计 与市场上的领先产品相比，&gt；的锚固力提高了250%。在这一第二阶段SBIR赠款中， 我们将完成FDA 510(K)批准的II类生物合成T-Line疝气网片的主要里程碑。它 从医学文献，市场报告，在线网络研讨会和播客，最近的语料库 在疝气会议上的演讲，以及我们世界级科学顾问委员会的指导，生物合成 疝气网片正迅速在市场上获得青睐，而生物合成的T-Line疝气网片 它的外科医生友好、生理学设计、卓越的锚定系统将在 外科护理。

ABSTRACT Laparotomy patients are plagued with ventral hernias occurring and recurring in up to 30% of cases. Hernia occurrence and recurrence is caused by anchor point failure of both permanent and degradable mesh (i.e. suture, tacks, and screws cheese-wire through mesh and tissue, resulting in mesh migration and/or contraction). Simply, hernias occur or recur where mesh is not adequately anchored to tissue and migrates or contracts. It is rare for moderate to heavy weight meshes to rip allowing hernias to occur through the torn mesh or for hernias to occur between intact mesh anchor points. Biosynthetic hernia mesh (i.e. a synthetic hernia mesh made from a biodegradable polymer) is the fastest growing segment of the hernia mesh market with ~$95M in sales in 2017. Moreover, several recent long-term occurrence (prevention) and recurrence (treatment) outcome studies have illustrated that newer degradable biosynthetic meshes, including Bio-A, Phasix, and TIGR mesh, promote tissue regeneration and are equivalent in performance and safety to permanent mesh and superior to xenografts and allografts. However, despite emerging data in support of biosynthetic mesh over permanent mesh and the gradual growth of biosynthetic mesh in the market place, biosynthetic meshes suffer from the same occurrence and recurrence problems as permanent mesh – both types of meshes lack an adequate soft tissue anchoring system. While anchor point failure has unquestionably been recognized for decades as the most common cause of ventral hernia recurrence, there are no mesh anchoring systems on the market designed to address this problem. Sutures (or tacks, screws, or glue) are simply insufficient. A better anchoring system is sorely needed. To meet this need, Deep Blue Medical Advances, Inc. (DBMA) has engineered a patented T-Line® Hernia Mesh anchoring system for use in open and laparoscopic repair and demonstrated the benefits with a permanent polypropylene mesh. DBMA has successfully completed Phase I goals selecting a biodegradable copolymer with appropriate mechanical properties and degradation rate to promote healing. The novel biosynthetic T-line Hernia Mesh design has >250% greater anchoring strength compared to leading products on the market. In this Phase II SBIR grant, we will complete major milestones for FDA 510(k) clearance of the class II biosynthetic T-Line Hernia Mesh. It is evident from the medical literature, market reports, online webinars and podcasts, corpus of recent presentations at hernia meetings, and guidance from our world-class scientific advisory board that biosynthetic hernia meshes are rapidly gaining favor in the marketplace and that the biosynthetic T-Line Hernia Mesh, with its surgeon-friendly, physiologically designed, superior anchoring system will have a transformative impact in surgical care.