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.

需要软组织修复方法的创新和涉及结缔组织松弛的支持， 许多临床应用。这些措施包括开发改善女性骨盆底疾病的治疗方法， dominal外科修复（疝），用于肌腱和韧带修复的骨科应用。其中一些 疾病，如女性压力性尿失禁（SUI）、盆腔器官脱垂（POP）和疝修补术， 通过使用合成材料如聚丙烯网作为护理标准进行处理。尽管如此， 报告了与在骨盆底疾病中植入聚丙烯补片相关的并发症发生率。 其他生物材料，如脱细胞同种异体移植物或异种移植物，缺乏容纳组织的孔隙度 因此，它们的物理性质随着时间的推移而降低，导致功能失效。因此，有一个 强烈的临床需求，开发创新的软组织修复和支持产品，以治疗这些改变生命的 妇女的健康状况，这些产品也会影响疝气、整形外科修复和其他领域。 CollaMeetings正在开发基于纯胶原蛋白线的新型植入式医疗设备， 获得专利的电化学压实工艺。医用级溶解牛I型胶原蛋白是 电压缩成线，这些线是最致密和最强形式的重建胶原蛋白。 因此，这些线可以被编织或缠绕成复杂的形状以制造生物织物 （CollaFabric™）以形成各种各样的生物可吸收植入物，所述植入物具有用于组织向内生长的充足孔隙率， 快速融合。CollaFabric在被分解的同时，在体内产生新的组织生长反应; 因此，它比合成塑料植入物性能更好，同时避免了负面副作用，包括挤出， 侵蚀和慢性炎症。凯斯西储大学的CollaMeiden和共同发明者 对CollaFabric在大鼠、家兔和最近在绵羊中进行了广泛的初步生物相容性研究， 即使在6个月时也显示出优异的组织整合和强度。生产的第一个产品系列 CollaFabric的产品将用于治疗女性SUI和POP，其次是用于其他应用的产品。 该项目的目的是完成基于CollaFabric的妇女SUI治疗的开发。 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，设计将被冻结。然后将对设计进行验证和确认， 包括包装确认、灭菌确认、生物相容性试验和体内植入试验， 在6个月绵羊研究中与现有同品种器械进行比较。这项工作的最终结果将是FDA 510（k） 应用程序.