A Repositionable Tissue Anchor for Osteoporortic Bone

描述（由申请人提供）：缝线锚钉提供了一种快速、安全和简单的手术方式，将软组织连接到骨上。自1985年推出以来，缝线锚钉已广泛用于各种外科手术。它们为外科医生和患者提供了显著的时间和成本节省。然而，目前的锚定器存在许多缺点。现有的缝线锚钉在骨质疏松骨中表现不佳，并且在植入后不能容易地重新定位。随着成年人活动量的增加，骨质疏松骨的附着问题将变得越来越重要。 我们建议开发一种新型的带线锚钉技术，该技术具有与现有器械相同的受益，但具有显著的优势。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，并且可以用作其他锚钉的翻修器械。 基于第一阶段的可行性确认，第二阶段工作的目标是肩袖修复锚的特定产品开发，随后是锚产品多样化产品线的设计修改。肩袖修复是一种高容量外科手术，通常涉及肱骨近端的劣质骨，标准锚器械无法提供足够的固定强度。该锚和相关插入工具的开发将利用有限元分析设计工具。将进行全面的实验室试验方案，以确定与市售等同器械的监管等同性，特别关注骨化骨模型中的固定强度。一组肩关节专家将通过在尸体模型中进行模拟肩袖修复来评估锚系统的效用。使用原型系统和当前器械的肩袖重建也将在动态肩关节测试系统中进行测试，以评估早期康复方案的周期性失效风险。文献中的许多参考文献表明，早期积极的康复方案可能导致锚固定强度显著降低、肩袖重建松弛，甚至手术失败率升高。由不同专业的外科医生组成的评审小组将在开发过程中提供规范，并对系统设计和最终项目结果进行严格评审。

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.