A Repositionable Tissue Anchor for Osteoporortic Bone

说明(申请人提供)：缝合锚提供了一种快速、安全和简单的手术方式将软组织附着到骨骼上。自1985年问世以来，缝合锚已被广泛应用于各种外科手术中。它们为外科医生和患者节省了大量的时间和成本。然而，目前的锚定有许多缺点。现有的缝线锚在骨质疏松的骨质中表现不佳，植入后不易重新定位。随着成年活跃人口的增长，对骨质疏松骨的依附问题将变得越来越重要。我们建议开发一种新的、新的缝合锚定技术，该技术具有与现有设备相同的好处，但产生显著的优势。这种新的锚侵入性更小，可以很容易地重新定位，在质量较差的骨中提供出色的性能，并可以用作其他锚的翻修装置。在第一阶段可行性确认的基础上，第二阶段工作的目标是开发肩袖修复锚的具体产品，然后针对不同的锚产品线进行设计修改。肩袖修复术是一种大容量的外科手术，通常涉及到标准的固定装置不能提供足够的固定强度的肱骨近端的劣质骨。该锚和相关插入工具的开发将利用有限元分析设计工具。将进行一项全面的台架测试方案，以建立与商业预测装置的监管等效性，特别关注骨质疏松骨模型中的固定强度。一组肩部专家将通过在身体模型上进行模拟袖带修复来评估锚定系统的实用性。使用原型系统和现有设备的肩袖重建也将在动态肩部测试系统中进行测试，以评估早期康复方案的周期性失败风险。许多文献表明，早期积极的康复方案可能会导致锚定固定强度的显著降低，袖带重建的松弛，甚至增加手术的失败率。一个由不同专业的外科医生组成的审查小组将在开发过程中贡献规格，并严格审查系统设计和最终项目结果。

DESCRIPTION (provided by applicant): Suture anchors provide a quick, secure, and simple means of surgically attaching soft tissue to bone. Since their introduction in 1985, suture anchors have been widely used in a variety of surgical procedures. They provide a significant savings in time and cost to both surgeon and patient. However, there are a number of shortcomings with current anchors. Existing suture anchors perform poorly in osteoporotic bone and cannot be repositioned easily following implantation. The issue of attachment to osteoporotic bone will become increasingly important with a growing active adult population. We propose the development of a novel, new suture anchor technology that possesses the same benefits of existing devices but yields significant advantages. The new anchor is less invasive, can be readily repositioned, provides exceptional performance in poor quality bone, and can be used as a revision device for other anchors. Based on the Phase I confirmation of feasibility, the goal of the Phase II work is the specific product development of the rotator cuff repair anchor, followed by design modification for a diverse product line of anchor products. Rotator cuff repair is a high volume surgical operation that often involves poor quality bone in the proximal humerus where standard anchor devices do not provide adequate fixation strength. The development of this anchor and associated insertion tooling will utilize a finite element analysis design tool. A thorough bench testing regimen will be performed to establish regulatory equivalence to a commercial predicate device, with a special focus on fixation strength in an osteoporotic bone model. A group of shoulder specialists will assess the utility of the anchor system by performing simulated cuff repairs in a cadaveric model. Rotator cuff reconstructions using the prototype systems and current devices will also be tested in a dynamic shoulder testing system to evaluate the cyclic failure risk of early rehabilitation protocols. Many references in the literature that indicate that early, aggressive rehabilitation regimens may cause a significant decrease in anchor fixation strength, laxity in the cuff reconstruction, and even the elevated failure rate of the operation. A review panel of surgeons in a diverse range of specialties will contribute specifications in the development process and critically review the system design and final project results.