Knotless Soft Tissue Augments for Improving Arthroscopic Rotator Cuff Repair Biomechanics

无结软组织增强物可改善关节镜下肩袖修复生物力学

• 批准号: 10546104
• 负责人: Michael Paul Francis
• 金额: $ 24.77万
• 依托单位: ASANTE BIO LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-23 至 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10546104
• 关键词: 3-Dimensional; 3D Print; Behavior; Biomechanics; Biomedical Engineering; Biopolymers; Boat; Cadaver; Caring; Cheese; Cicatrix; Clinical; Complex; Consumption; Data; Engineering; Ensure; Failure; Fiber; Head; Health; Hernia; Human; Implant; Injury; Joint repair; Knowledge; Mechanics; Medical; Medical Device; Methods; Mission; National Institute of Arthritis and Musculoskeletal and Skin Diseases; Nature; Occupations; Operative Surgical Procedures; Pain; Patients; Performance; Periodicity; Persistent pain; Phase; Polymers; Preclinical Testing; Procedures; Property; Psychological reinforcement; Research; Rotator Cuff; Small Business Innovation Research Grant; Surgeon; Surgical Management; Surgical sutures; Tendon structure; Testing; Textiles; Time; Tissue Engineering; Tissues; Work; base; biomaterial compatibility; biomechanical test; bone; clinical practice; cost effective; design; disability; field study; healing; improved; innovation; innovative technologies; mechanical load; novel; older patient; prevent; prospective; repaired; rotator cuff injury; scaffold; soft tissue; standard of care; success; supraspinatus muscle; tissue repair; ultra-high molecular weight polyethylene

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.

无节软组织假体改善关节镜下肩袖修复的生物力学性能 负荷分担和无结缝合加强软组织提供了一种破坏性的和 管理肩袖损伤和可能发生的其他损伤的外科护理的创新技术 缝合线拔出可能会产生灾难性的影响。此第一阶段SBIR提案致力于开发一种 通过创新的软组织增强(STA)植入物来改进新的研究领域和重新定义临床实践 肩袖修复术及相关手术中的缝合负荷分配与组织愈合。的重要意义。 该项目是坚固、强化、可吸收的聚合物植入物的医学工程，将允许 研究接头修复稳定性，了解RCR失效的原因/机理，并最终预防 这些失败是通过商业产品实现的。NIAMS任务的核心是手术RCR后肌腱再次撕裂 发生在高达20%-45%或更高的初级维修中。这种失败率是一个不可接受的事实，因为 仅在美国，每年就有80万例RCR手术。此外，肩袖损伤不会愈合。 好了自己，造成行动不便，持续疼痛，并影响恢复活动。 目前的RCR手术策略包括广泛使用关节镜下通过的缝线以提供 组织近似值。不幸的是，单纯缝合的修复通常会失败，反而会导致机械性能下降。 疤痕组织形成，容易导致随后的失败、疼痛和残疾。肌腱到缝合线的界面是 被认为是最常见的RCR故障模式。假设RCR故障通过GAP发生 在末端形成，主要是由于延长或缝合切开在缝合-肌腱界面。STAS 我们的工程学将分配和分担机械载荷，并防止缝合到肌腱的失败 显著提高RCR的创新方法。假设：如果软组织增强剂(STA)改善组织 通过加强基于标准缝线的肩袖修复来修复生物力学，然后2型再撕裂将被 显著减少。 目的1：测定和优化软组织增强生物力学性能。方法：3D 打印肌腱增强植入物将由PDO和来自两个STA设计的UHMWPE生产 (圆形和舌形)，用于外科医生评估和模拟使用。肌腱缝合加强物将在 用于确认关节镜下分娩的身体。此外，通过外科手术在修复的肌腱上放置STA将会 在与仅缝合修复相关的拉断和循环测试中进行生物力学性能测试 (护理标准)。 目的2：测定软组织增强材料的稳定性和生物相容性。方法：STA还将 根据国际标准化组织10993-6进行生物兼容性评估。STA植入物的稳定性也将根据ASTM进行评估 1635-16标准测试以确定软组织隆起物的吸收率。