Mitral Valve Repair Device

描述（由申请人提供）：二尖瓣返流是一种与心脏病相关的严重疾病。治疗这种疾病的最常见和有效的手术方法是使用瓣环成形术环，其减小扩张的二尖瓣的尺寸以恢复正常功能。然而，许多患者不接受这种手术，要么是因为他们病得太重而不能接受心脏直视手术，要么是因为他们的病情尚未发展到手术合理的程度。为了解决这个庞大的未经治疗的患者群体，已经进行了许多努力来开发通过导管修复泄漏的二尖瓣的技术。其中，Millipede概念是唯一可以进行真正的环成形术的器械。该概念使用支架样环，其可以在径向力下扩张和收缩，并且在其周边具有许多小的倒钩支柱。在输送之前，将环安装在可扩张的锥形输送工具的远端。将收缩的瓣膜-环组件向瓣环推进，并将圆锥体的顶点推过瓣膜口。然后扩张锥体，同时将环扩张至已知直径，并迫使环成为具有相同直径的圆形形状，从而使环和环自动对齐。一旦对准，简单地向前推动输送工具将倒钩支柱驱动到组织中并将环固定到位。然后向下收缩并取出扩张器工具。在本项目的第一阶段，我们将构建瓣膜成型环和输送系统的功能原型，并在猪心实验台上测试其性能。在第二阶段，我们将进一步开发该器械，并进行必要的测试，以获得外科手术使用的监管批准。 公共卫生相关性：本项目的目标是开发一种经皮二尖瓣成形环，用于治疗扩张、泄漏的心脏瓣膜。这项技术将允许不经手术治疗二尖瓣泄漏，这将使大量患有瓣膜疾病但不适合手术的患者受益。

DESCRIPTION (provided by applicant): Mitral valve regurgitation is a serious condition related to heart disease. The most common and effective surgical method for treating this disease is with the use of an annuloplasty ring, which reduces the size of a dilated mitral valve to restore normal function. Many patients do not receive this procedure, however, either because they are too sick to undergo open heart surgery, or their condition has not yet progressed to the point at which surgery is justified. To address this large untreated patient population, many efforts have been undertaken to develop technology to repair leaky mitral valves via catheter. Of these, the Millipede concept is the only device which can perform a true ring annuloplasty. This concept uses a stent-like ring that can both expand and contract under a radial force and has many small barbed struts around its perimeter. The ring is mounted on the distal end of an expandable, cone- shaped delivery tool prior to delivery. The collapsed dilator-ring assembly is advanced toward the annulus and the apex of the cone is pushed through the valve orifice. The cone is then expanded, which simultaneously expands the ring to a known diameter and forces the annulus into a circular shape with the same diameter, resulting in automatic alignment of the ring and the annulus. Once aligned, a simple forward push of the delivery tool drives the barbed struts into the tissue and secures the ring in place. The dilator tool is then contracted down and removed. In Phase I of this project we will build functional prototypes of the ring and delivery system and test their performance on the benchtop in pig hearts. In Phase II we will further develop this device and conduct testing necessary to achieve regulatory approval for surgical use. PUBLIC HEALTH RELEVANCE: The goal of this project is to develop a percutaneous mitral annuloplasty ring for the treatment of dilated, leaking heart valves. This technology will allow leaky mitral valves to be treated without surgery, which will benefit a significant number of patients who have valve disease but are not candidates for surgery.