Knotless Soft Tissue Augments for Improving Arthroscopic Rotator Cuff Repair Biomechanics

无结软组织垫块改善关节镜下肩袖修复的生物力学 使用无结缝线增强垫块分担载荷和加强软组织， 用于肩袖损伤和其他损伤手术治疗的创新技术 缝合线拉穿可能会造成灾难性后果。第一阶段SBIR提案致力于开发一个 新的研究领域，并通过创新的软组织增强（STA）植入物重新定义临床实践， 肩袖修复术（RCR）和相关手术中缝线负荷分布和组织愈合。的意义 这个项目是一个医学工程的强大，加强，可吸收的聚合物植入物，将允许 研究关节修复稳定性，了解RCR失败的原因/机制，并最终预防 这些故障通过商业产品。NIAMS使命的核心，手术RCR后肌腱再撕裂 发生在高达20-45%或更多的初次修复中。这种失败率是不可接受的事实，因为 仅在美国，每年就进行80万例RCR手术。此外，肩袖损伤不会愈合 它们本身很好，导致活动受限，持续疼痛，并影响活动恢复。 目前的RCR手术策略包括广泛使用关节镜下穿过的缝线， 组织缝合。不幸的是，仅缝合修复通常失败，反而导致机械薄弱 瘢痕组织形成，容易导致随后的失败、疼痛和残疾。肌腱-缝线界面 被认为是最常见的RCR失效模式。假设RCR失效通过间隙发生 在缝合点形成，主要是由于缝线-肌腱界面处的延长或缝线切穿。个sta 我们的工程师将分配和分担机械负荷，并防止缝合肌腱失败， 创新方法，显著提高RCR。假设：如果软组织增强垫块（STA）改善组织 通过加强标准的基于缝线的肩袖修复来修复生物力学，然后将2型再撕裂 大幅减少。 目的1：确定和优化软组织增强体的生物力学性能。方法：3D 打印的肌腱增强垫块植入物将由两种STA设计的PDO和UHMWPE生产 （圆形和翼片形），用于外科医生评估和模拟使用。肌腱缝线增强垫块将在 用于验证关节镜手术的尸体。此外，通过手术放置在修复肌腱上的STA将 相对于仅使用缝线修复，在拉力失效和循环测试中测试生物力学性能 (the护理标准）。 目的2：确定软组织垫块的稳定性和生物相容性。方法：STA还将 根据ISO 10993-6评估生物相容性。还将根据ASTM评估STA植入物稳定性 1635-16标准测试，以确定软组织垫块的吸收率。

Knotless Soft Tissue Augments for Improving Arthroscopic Rotator Cuff Repair Biomechanics Load sharing and reinforcing soft tissue with knotless suture augments present a disruptive and innovative technology to managing the surgical care of rotator cuff injuries and prospectively other injuries where suture pull-through can have catastrophic effects. This phase I SBIR proposal endeavors to develop a new field of study and redefine clinical practice via innovative soft tissue augment (STA) implants to improve suture load distribution and tissue healing in rotator cuff repair (RCR) and related surgeries. The significance of this project is medical engineering of strong, reinforcing, resorbable polymeric implants that will allow for studying joint repair stability, understanding the causes/mechanisms of RCR failure, and ultimately preventing these failures via a commercial product. Central to the NIAMS mission, tendon re-tear following surgical RCR occurs in as high as 20-45% or more of primary repairs. This failure rate is an unacceptable fact, given that 800,000 RCR procedures are performed annually in the U.S. alone. In addition, rotator cuff injuries do not heal well on their own, cause limited mobility, persistent pain, and impact return to activity. Current RCR surgical strategies involve extensive use of sutures passed arthroscopically to provide tissue approximation. Unfortunately, suture-only repair commonly fails and instead leads to mechanically weak scar tissue formation, prone to subsequent failure, pain, and disability. The tendon-to-suture interface is believed to be the most common RCR failure mode. It is hypothesized that RCR failure occurs via gap formation at the enthesis, primarily due to elongation or suture cut-through at the suture-tendon interface. STAs we are engineering will distribute and share the mechanical load and prevent suture-to-tendon failure as an innovative approach to significantly improve RCR. Hypothesis: If Soft Tissue Augments (STAs) improve tissue repair biomechanics by reinforcing standard suture-based rotator cuff repair, then type 2 retears will be significantly reduced. Aim 1: To determine and optimize soft tissue augment biomechanical properties. Approach: 3D printed tendon augments implants will be produced from PDO and UHMWPE from the two STA designs (round and tab shaped) for surgeon assessment and simulated use. The tendon suture augments will be tested in cadavers for validating arthroscopic delivery. In addition, STAs surgically placed on the repaired tendons will be tested for biomechanical performance in pull-to-failure and cyclic testing relative to repair with only sutures (the standard of care). Aim 2: To determine soft tissue augment stability and biocompatibility. Approach: STA will also be assessed for biocompatibility per ISO 10993-6. The STA implant stability will also be assessed per ASTM 1635-16 standard testing to determine the resorption rate of the soft tissue augments.