A Biosynthetic Degradable Textile for Soft Tissue Reconstruction

摘要 剖腹手术患者的困扰与腹疝发生和复发的情况下，高达30%。疝 发生和复发是由永久性和可降解补片的锚点失效引起的（即， 缝线、平头钉和螺钉使粗钢丝穿过补片和组织，导致补片移位和/或 收缩）。简单地说，疝发生或复发的部位是补片未充分锚定到组织上并移位或 合同.中到重型补片很少撕裂，从而导致疝穿过撕裂的补片发生 或者在完整的网状物锚点之间发生疝。生物合成疝补片（即合成疝 由可生物降解聚合物制成的补片）是疝补片市场增长最快的部分， 2017年销售额约9500万美元。此外，最近发生的几个长期（预防）和复发 （治疗）结果研究表明，更新的可降解生物合成补片，包括Bio-A， Phasix和TIGR补片可促进组织再生，在性能和安全性方面等同于 永久性补片，且上级优于异种移植物和同种异体移植物。然而，尽管新出现的数据支持 生物合成补片优于永久性补片以及市场上生物合成补片的逐渐增长， 生物合成补片与永久性补片存在相同的发生和复发问题， 各种类型的网状物缺乏足够的软组织锚定系统。虽然锚点失效毫无疑问 几十年来被认为是腹疝复发的最常见原因， 市场上的锚定系统被设计来解决这个问题。缝线（或大头钉、螺钉或胶水） 只是不够。我们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 Advances，Inc.（DBMA）设计了一种专利的T-Line®疝修补网片锚定系统，用于开放和 腹腔镜修复，并证明了永久性聚丙烯补片的受益。DBMA拥有 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 性能和降解速率，以促进愈合。新型生物合成T型疝补片设计具有 与市场上的领先产品相比，锚定强度高出250%以上。在第二阶段SBIR赠款中， 我们将完成II类生物合成T型疝补片FDA 510（k）批准的主要里程碑。它 从医学文献、市场报告、在线研讨会和播客、最近的语料库中可以看出， 在疝气会议上的演讲，以及我们世界级的科学顾问委员会的指导， 疝补片在市场上迅速获得青睐， 它的外科医生友好，生理设计，上级锚定系统将产生变革性的影响， 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.