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: 10460582
• 负责人: David Ruppert
• 金额: $ 61.71万
• 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 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10460582
• 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 剖腹手术患者遭受腹腔疝的困扰，并在多达30％的病例中反复出现。疝 发生和复发是由永久和可降解网格的锚点失败引起的（即 缝合，大头钉和螺丝奶酪线通过网状和纸巾拧紧，导致网状迁移和/或 收缩）。简而言之，疝气发生或重复发生，而网状没有充分锚定在组织并迁移或 合同。中度至重量的网眼很少会撕裂，从而使疝气通过撕裂的网眼发生 或使疝气发生在完整的网状锚点之间。生物合成疝（即合成的疝气 由可生物降解的聚合物制成的网格）是疝网市场中增长最快的细分市场 2017年的销售额为9500万美元。此外，最近的几次长期出现（预防）和复发 （治疗）结果研究表明，包括生物-A在内的新的可降解生物合成网格， phasix和Tigr网格，促进组织再生，性能和安全性等效于 永久网格，优于Xenographing和同种异体移植物。但是，dospite新兴数据支持 永久网状网格的生物合成网和在市场上生物合成网的等级增长， 生物合成网格遭受与永久网格相同的发生和复发问题 - 两者都 网格类型缺乏足够的软组织锚定系统。毫无疑问，锚点故障 几十年来被认为是腹性疝复发的最常见原因，没有网状 旨在解决此问题的市场上的锚定系统。缝合线（或钉，螺钉或胶）是 只是不足。迫切需要一个更好的锚定系统。为了满足这种需求，深蓝色医疗 Advances，Inc。（DBMA）已设计了一个专利的T-Line®疝网锚定系统，可用于开放和 腹腔镜修复并通过永久性聚丙烯网格证明了益处。 DBMA有 成功完成I阶段目标，选择具有适当机械的可生物降解共聚物 属性和降解率以促进愈合。新颖的生物合成T线疝网的设计具有 与市场上的领先产品相比，锚定强度> 250％。在此阶段II sbir赠款中， 我们将完成II类生物合成Tline Hernia网格的FDA 510（K）清除的主要里程碑。它 是医学文献，市场报告，在线网络研讨会和播客的证据，最近的语料库 在疝气会议上的演讲以及我们世界一流的科学顾问委员会的指导 疝网迅速在市场上获得青睐，并且生物合成T线疝网与 其对外科医生友好，身体设计的，上级锚定系统将对 手术护理。