Millipede Percutaneous Annuloplasty Ring

描述（由申请人提供）：心脏瓣膜反流是一种与心脏病相关的严重疾病。治疗这种疾病最常见和有效的手术方法是使用环成形术环，它可以缩小扩张的瓣膜环的大小，以恢复正常功能。然而，许多患者没有接受这种手术，要么是因为他们病得太重，无法进行心内直视手术，要么是因为他们的病情还没有发展到需要进行手术的程度。为了解决这个庞大的未经治疗的患者群体，许多努力已经进行了开发技术，通过导管修复泄漏的瓣膜。在这些设备中，Millipede概念是唯一可以执行真正的环形成形术的设备。这个概念使用了一个可以在径向力下膨胀和收缩的环，并在其周围有许多小的倒钩锚。所述环在交付之前安装在可扩展的锥形交付工具的近端。将坍缩的膨胀环组件向环空推进，并将锥体的顶点推过阀孔。然后将锥扩展，同时将环扩展到已知直径，并将环空强制成具有相同直径的圆形，从而使环和环空自动对齐。对准后，只需简单地向前推动输送工具，就可以将带刺锚钉送入组织中，并将环固定到位。然后收缩并取出扩张器工具。在这个项目的第一阶段，我们将构建环和交付工具的功能原型，并在猪心脏的工作台上测试它们的性能。在第二阶段，我们将进一步开发这种设备，并进行必要的测试，以获得监管部门的批准，用于外科手术。同样在第二阶段，我们将开发经皮植入设备所需的输送系统。

DESCRIPTION (provided by applicant): Heart 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 valve annulus 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 valves via catheter. Of these, the Millipede concept is the only device which can perform a true ring annuloplasty. This concept uses a ring that can both expand and contract under a radial force and has many small barbed anchors around its perimeter. The ring is mounted on the proximal 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 anchors 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 tool 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. Also in Phase II, we will develop the delivery system needed to implant the device percutaneously. PUBLIC HEALTH RELEVANCE: The goal of this project is to develop a sutureless annuloplasty ring for the treatment of dilated, leaking heart valves. This will lead to an annuloplasty ring that can be implanted without surgery, which will benefit a significant number of patients who have valve disease but are not candidates for surgery.