Collagen-based tissue guidance biofabric for treatment of stress urinary incontinence

基于胶原蛋白的组织引导生物纤维用于治疗压力性尿失禁

• 批准号: 10010584
• 负责人: Subba Shankar
• 金额: $ 76.88万
• 依托单位: COLLAMEDIX INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-04-15 至 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10010584
• 关键词: Abdomen; Absorbable Implants; Allografting; Automation; Biocompatible Materials; Caliber; Cattle; Cells; Chronic; Cicatrix; Clinical; Collagen; Collagen Type I; Complex; Connective Tissue; Data; Data Collection; Deposition; Development; Device Designs; Devices; Diamond; Disease; Ensure; Equilibrium; Failure; Family; Fascia; Feedback; Female; Filament; Freezing; Funding; Growth; Hernia; Histologic; Histology; Human; Implant; Incidence; Inflammation; Legal patent; Life; Ligaments; Measures; Mechanics; Medical; Medical Device; Modulus; Operative Surgical Procedures; Organism; Orthopedics; Oryctolagus cuniculus; Pattern; Pelvic Floor Disorders; Pelvis; Phase; Plants; Polypropylenes; Porosity; Process; Production; Property; Rattus; Reporting; Running; Shapes; Sheep; Shipping; Sterility; Sterilization; Stress Urinary Incontinence; Structure; System; Techniques; Tendon structure; Testing; Time; Tissues; Toxic effect; Universities; Validation; Weight-Bearing state; Woman; Work; Xenograft procedure; aged; base; biomaterial compatibility; clinical application; cost; density; design; health application; implant design; implantation; improved; in vivo; innovation; meetings; novel; pelvic organ prolapse; physical property; prototype; reconstitution; repaired; response; scale up; side effect; soft tissue; standard of care; subcutaneous; tissue repair; verification and validation; wound

Innovation in approaches for soft tissue repair and support involving connective tissue laxity are needed for many clinical applications. These include developing improved treatments for female pelvic floor disorders, ab- dominal surgical repair (hernia), orthopedic applications for tendon and ligament repairs. Some of these disorders, such as stress urinary incontinence (SUI) in women, pelvic organ prolapse (POP) and hernia repair, are treated by using synthetics such as polypropylene mesh as the standard of care. Nonetheless there is a high reported incidence of complications relating to the implantation of polypropylene mesh in pelvic floor disorders. Other biomaterials, such as decellularized allografts or xenografts, lack porosity to accommodate tissue integration; thus, their physical properties diminish over time, resulting in functional failure. There is, therefore, a strong clinical need to develop innovative soft-tissue repair and support products to treat these life-altering conditions in women and such products would also impact hernia, orthopedic repairs, and other fields as well. CollaMedix is developing new implantable medical devices based on pure collagen threads formed by a novel, patented electrochemical compaction process. Medical-grade solubilized bovine Type I collagen is electrocompacted into threads that are among the most dense and strongest forms of reconstituted collagen. Therefore, these threads can be woven or filament-wound into complex shapes to make a biofabric (CollaFabric™) to form a wide variety of bioabsorbable implants that have ample porosity for tissue ingrowth and rapid integration. CollaFabric produces a new tissue growth response in the body while it is being broken down; thus, it performs better than synthetic plastic implants, while avoiding negative side effects, including extrusion, erosion, and chronic inflammation. CollaMedix and co-inventors at Case Western Reserve University have conducted extensive preliminary biocompatibility studies on CollaFabric in rats, rabbits, and recently on sheep, that showed excellent tissue integration and strength even at 6 months. The first family of products produced from CollaFabric will be for the treatment of SUI and POP in women, followed by products for other applications. The aim of this project is to complete the development of a SUI treatment for women based on CollaFabric. The proposed activities and data collection are based on direct feedback from FDA. The design of existing CollaFabric prototypes will be optimized and the design frozen. The design will then be verified and validated, including packaging validation, sterilization validation, biocompatibility testing, and in vivo implant testing, with comparison to an existing predicate, in a 6-month sheep study. The end result of this work will be an FDA 510(k) application.

需要在涉及结缔组织松弛的软组织修复和支撑的方法中进行创新 许多临床应用。这些包括开发改进的女性骨盆底疾病的治疗方法 二分性手术修复（疝），肌腱和韧带维修的骨科应用。其中一些 疾病，例如女​​性的压力尿失禁（SUI），骨盆脱垂（POP）和疝气修复， 通过使用合成（例如聚丙烯网格）作为护理标准来处理。尽管如此 报告的并发症与聚丙烯网格植入骨盆底疾病有关的并发症。 其他生物材料，例如脱细胞同种异体移植或Xenographictics，缺乏可容纳组织的孔隙率 一体化;因此，它们的物理特性会随着时间的流逝而减少，从而导致功能失效。因此，有一个 强大的临床需求开发创新的软组织维修和支持产品以治疗这些改变生活 女性和此类产品的状况也会影响疝气，骨科维修以及其他领域。 Comleamedix正在开发基于小说形成的纯胶原蛋白线的新型植入医疗设备 专利的电化学压实过程。医学级可溶性牛I胶原蛋白是 电反应成螺纹，这是最密集，最强的重构胶原蛋白。 因此，这些线可以被编织或丝状缠绕成复杂的形状以制成生物效果 （Collafabric™）形成各种可生物吸附的玻璃，具有足够的孔隙率 快速整合。分解时，Collafabric会在体内产生新的组织生长反应。 因此，它的性能要比合成塑料的浓度更好，同时避免了负面副作用，包括延伸， 侵蚀和慢性炎症。 Case Western Reserve University的Comalamedix和联合委托人 对大鼠，兔子和最近的绵羊进行了广泛的初步生物相容性研究， 即使在6个月时，这也显示出出色的组织整合和强度。生产的第一个产品 来自Collafabric将用于女性的SUI和POP，然后是其他应用产品。 该项目的目的是完成基于Collafabric的女性的SUI治疗。 拟议的活动和数据收集基于FDA的直接反馈。现有的设计 Collafabric原型将被优化并冻结。然后将验证和验证该设计， 包括包装验证，灭菌验证，生物相容性测试和体内植入物测试 在一项为期6个月的绵羊研究中，与现有谓词进行了比较。这项工作的最终结果将是FDA 510（k） 应用。