A Shear Force Transfer Coupling for Soft Tissue Repair

描述（由申请人提供）：伤口闭合有时会失败，因为组织缺乏缝线和斯台普斯所需的组织化结缔组织。在2004年，我们评估了FiberSecure的可行性（第一阶段）;这是一种与传统密封件根本不同的耦合：通过剪切力而不是直接力或法向力进行固定。我们在该研究和其他研究（骨科和心脏动力用途）中表明，数千根细聚酯纤维的耦合，作为束插入，迅速被固体组织向内生长。保持强度达到理论极限，即，组织强度本身。这是植物根原纤维即使在软土中也能牢固保持的机制。这些试验表明，与严格应用的对照闭合相比，保持力更强的概率很高（在本阶段I中p<0.002）。有四个具体目标：（1）在12个月植入期内的愈合稳定性，从资金开始，因此任何后期变化都得到了识别和解决（2）通过随机区组研究选择最终设计，从组织学、组织化学和强度方面对2种可能有用的变化进行研究，（3）通过与经验丰富的商业合作伙伴的制造过程使该设计适应监管（GMP）标准，以及（4）在GLP（良好实验室规范）认证的设施中研究这些GMP产品180天。测试使用Sinclair小型猪的腹部肌肉模型。实现这4个目标将导致器械在研究方案下用于临床，作为FDA提交的基础。510（k）法规适用。人类和商业利益将是巨大的。虽然传统的耦合器对于坚固的组织工作得很好，但许多耦合器在组织中经常失败。在许多外科学科中，死亡率和残疾发生在从腹部缝合伤口裂开（爆裂或裂开）到子宫肌瘤切开术或剖宫产后围产期子宫破裂，到钝性创伤后各种组织修复不成功，到正常（无瘢痕）瓣环中的心脏瓣膜置换术中断。每一种都可能是致命的。这是一种可以满足这种需求的设备。这项工作对于实现这一目标至关重要。

DESCRIPTION (provided by applicant): Wound closures sometimes fail because tissues lack the organized connective tissue required by sutures and staples. In 2004, we assessed feasibility (Phase I) of FiberSecure; a coupling fundamentally different from conventional closures: holding is by shear, not direct or normal force. We showed, in that study and others (orthopedic and cardiac power uses), that this coupling of thousands of fine polyester fibers, inserted as bundles are rapidly ingrown by solid tissue. Holding strength reaches theoretical limits i.e., tissue strength itself. It is the mechanism by which root fibrils of plants hold fiercely even in soft soil. These trials have shown, to high probability (p<0.002 in this Phase I), stronger holding than control closures meticulously applied. There are 4 specific aims: (1) Validate healing stability in 12-month implantation begun at funding so any late changes are recognized and addressed (2) Select final design by randomized block study of 2 plausibly useful variations, from histology, histochemistry, and strength, (3) Adapt that design to regulatory (GMP) standards through a manufacturing process with a widely experienced commercial partner, and (4) Study those GMP products for 180 days in a GLP (Good Laboratory Practices) certified facility. Testing uses an abdominal muscle model in Sinclair Miniature Swine. Achieving these 4 aims would result in devices for clinical use under a investigational protocol as the basis for an FDA submission. 510(k) regulations apply. Human and commercial benefit would be enormous. While conventional couplings work quite well for strong tissues, many couplings are in tissues where they too often fail. Mortality and disability follow, across many surgical disciplines, from dehiscence (bursting apart or splitting open) of a sutured abdominal wound, to peripartum uterine rupture after fibroid myotomy or prior cesarean, to unsuccessful repairs of diverse tissues after blunt trauma, to disrupted heart valve replacements in normal (unscarred) annuli. Each may be lethal. This is a device that can address that need. This work is pivotal to its realization.