A Biosynthetic Degradable Textile for Soft Tissue Reconstruction

用于软组织重建的生物合成可降解纺织品

• 批准号: 10325360
• 负责人: David Ruppert
• 金额: $ 106.38万
• 依托单位: DEEP BLUE MEDICAL ADVANCES, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-08-12 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10325360
• 关键词: Address; Affect; Allografting; Biological; Caliber; Carbonates; Caring; Characteristics; Cheese; Cicatrix; Climate; Clinical; Contracts; Data; Devices; Engineering; Ensure; Evaluation; Exposure to; Failure; Family suidae; Fascia; Funding; Glues; Goals; Grant; Growth; Health Care Costs; Hernia; Human; Implant; Infection; Investments; Laparotomy; Legal patent; Life; Literature; Measures; Mechanics; Medical; Medical Device; Needles; Operative Surgical Procedures; Outcome Study; Pathway interactions; Patients; Performance; Phase; Physiological; Polypropylenes; Positioning Attribute; Prevention; Privatization; Process; Process Assessment; Product Packaging; Recurrence; Reporting; Research Design; Risk; Risk Assessment; Safety; Sales; Site; Small Business Innovation Research Grant; Sterility; Surgeon; Surgical sutures; System; Technology; Testing; Textiles; Tissues; Transportation; Treatment outcome; United States; United States National Institutes of Health; Ventral Hernia; Weight; Xenograft procedure; absorption; base; biodegradable polymer; caprolactone; commercialization; copolymer; cost; cyclopropane; design; experience; healing; implantation; improved; manufacturing process; mechanical properties; meetings; migration; novel; performance tests; physical property; podcast; prevent; programs; repaired; safety testing; seal; soft tissue; success; surgery outcome; tissue reconstruction; tissue regeneration; usability; webinar; wound

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.

抽象的 剖腹手术患者中，高达 30% 的患者会遭受腹疝的困扰。疝 发生和复发是由永久网和可降解网（即，可降解网）的锚点失效引起的。 缝合、大头钉和螺钉穿过网片和组织，导致网片迁移和/或 收缩）。简而言之，疝气发生或复发的地方是网片没有充分固定在组织上并迁移或 合同。中等到重型网片很少会撕裂，从而导致通过撕裂的网片出现疝气 或者在完整的网状锚点之间发生疝气。生物合成疝气网（即合成疝气 由可生物降解聚合物制成的网片）是疝气网片市场中增长最快的部分 2017 年销售额约 9500 万美元。此外，最近的一些长期发生（预防）和复发 （治疗）结果研究表明，更新的可降解生物合成网，包括 Bio-A， Phasix 和 TIGR 网片可促进组织再生，其性能和安全性与 永久性网片，优于异种移植物和同种异体移植物。然而，尽管有新出现的数据支持 生物合成网片优于永久网片以及生物合成网片在市场上的逐渐增长， 生物合成网片与永久网片存在同样的发生和复发问题 - 两者都是 各种类型的网片缺乏足够的软组织锚定系统。虽然锚点失效无疑 几十年来一直被认为是腹疝复发的最常见原因，但目前还没有补片 市场上的锚固系统旨在解决这个问题。缝合线（或平头钉、螺钉或胶水） 根本不够。迫切需要更好的锚定系统。为了满足这一需求，深蓝医疗 Advances, Inc. (DBMA) 设计了一种获得专利的 T-Line® 疝气网锚定系统，用于开放式和 腹腔镜修复并展示了永久性聚丙烯网的好处。 DBMA 有 选择具有适当机械性能的可生物降解共聚物，成功完成了第一阶段的目标 促进愈合的特性和降解率。新颖的生物合成 T 线疝网设计具有 与市场上的领先产品相比，锚固强度高出 250% 以上。在第二阶段 SBIR 拨款中， 我们将完成 II 类生物合成 T-Line 疝气网片获得 FDA 510(k) 批准的重要里程碑。它 从医学文献、市场报告、在线网络研讨会和播客、最近的语料库中可以明显看出 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 疝气网片在市场上迅速受到青睐，生物合成 T-Line 疝气网片具有 其外科医生友好型、符合生理学设计的卓越锚定系统将对以下领域产生变革性影响： 手术护理。