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.

无结软组织增强型用于改善关节镜肩袖修复生物力学 用无结缝合线增大的负载共享和加固软组织具有破坏性和 创新技术来管理肩袖受伤的手术护理和前瞻性伤害 缝合式拉的地方会产生灾难性的影响。这阶段我的提议努力开发 通过创新的软组织增强（STA）植入物改进的新研究和重新定义临床实践 肩袖修复（RCR）和相关手术中的缝合负荷分布和组织愈合。的意义 该项目是强大，增强，可吸收的聚合物植入物的医学工程，可以允许 研究关节维修稳定性，了解RCR失败的原因/机制，并最终阻止 这些通过商业产品失败。 Niams任务的中心，手术RCR后肌腱重新训练 出现高达20-45％或更多的主要维修。鉴于此失败率是一个不可接受的事实 仅在美国，每年一次执行800,000个RCR程序。此外，肩袖受伤无法治愈 依靠自己，会导致有限的流动性，持续性疼痛以及影响重返活动。 当前的RCR手术策略涉及广泛使用通过关节镜通过的缝合线以提供 组织近似。不幸的是，纯缝合修理通常会失败，而是机械弱 疤痕组织的形成，容易发生后续失败，疼痛和残疾。肌腱到缝线接口是 认为是最常见的RCR故障模式。假设RCR失败是通过间隙发生的 在缝隙处形成，主要是由于缝合线界面处的伸长或缝合线切割。 Stas 我们的工程将分发和分享机械负载，并防止缝合到螺丝 - 螺旋式失败 创新的方法可显着改善RCR。假设：如果软组织增强（Stas）改善组织 维修生物力学通过加强标准缝合式肩袖修复，然后将2个式播音为 大幅减少。 目标1：确定和优化软组织增强生物力学特性。方法：3D PDO和UHMWPE将通过两个STA设计生产印刷肌腱增强植入物 （圆形和标签形状）用于外科医生评估和模拟使用。肌腱缝合线的增强将在 用于验证关节镜分娩的尸体。此外，将STA手术放在修复的肌腱上 仅使用缝合线的维修中的拉力到失败和循环测试进行生物力学性能测试 （护理标准）。 目标2：确定软组织增强稳定性和生物相容性。方法：Sta也将 根据ISO 10993-6评估生物相容性。根据ASTM，也将评估STA植入物稳定性 1635-16标准测试以确定软组织增强的吸收率。