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

涉及结缔组织松弛的软组织修复和支持方法需要创新 许多临床应用。这些措施包括开发改善女性盆底疾病的治疗方法，ab. 腹膜外科修复(疝气)，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， 是通过使用合成材料如聚丙烯网眼作为护理的标准。尽管如此，还是有一个很高的 报告了与盆底疾病的聚丙烯网片植入相关的并发症的发生率。 其他生物材料，如脱细胞同种异体移植物或异种移植物，缺乏容纳组织的孔洞。 因此，它们的物理性能会随着时间的推移而减弱，从而导致功能故障。因此，有一种 临床上迫切需要开发创新的软组织修复和支持产品来治疗这些改变生活的人 女性和此类产品的状况也会影响疝气、整形外科修复和其他领域。 CollaMedex正在开发基于一种新型胶原线形成的纯胶原线的新型植入式医疗设备， 获得专利的电化学压实工艺。医用级溶解的牛I型胶原是 电致密线是重组胶原蛋白最致密和最坚固的形式之一。 因此，这些线可以被编织或纤维缠绕成复杂的形状，以制造生物纤维 (CollaFabric™)以形成各种生物可吸收植入物，这些植入物具有足够的组织内生和孔隙度 快速整合。CollaFabric在体内分解时会产生一种新的组织生长反应； 因此，它比合成塑料植入物表现更好，同时避免了负面副作用，包括挤压， 侵蚀和慢性炎症。科拉梅迪克斯和凯斯西储大学的共同发明人 在大鼠、兔和最近的绵羊身上进行了广泛的CollaFabric的初步生物相容性研究， 这表明，即使在6个月大的时候，也表现出了良好的组织整合和强度。生产的第一个产品系列 CollaFabric将用于治疗女性的SUI和POP，随后将推出其他应用产品。 该项目的目的是完成基于CollaFabric的女性SUI治疗的开发。 拟议的活动和数据收集是基于FDA的直接反馈。既有建筑的设计 CollaFabric的原型将被优化，设计将冻结。然后将对设计进行验证和确认， 包括包装验证、灭菌验证、生物兼容性测试和体内植入测试， 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) 申请。

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.