Millipede Percutaneous Annuloplasty Ring

描述(申请人提供)：心脏瓣膜返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最有效的手术方法是使用瓣环成形术，它可以缩小扩张的瓣环的大小，恢复正常的功能。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而不能接受心脏直视手术，要么是因为他们的病情还没有发展到可以进行手术的地步。为了解决这一庞大的未经治疗的患者群体，已经采取了许多努力来开发技术来通过导管修复泄漏的瓣膜。在这些设备中，Millipede概念是唯一可以进行真正的环状成形术的设备。这一概念使用了一个既能在径向力下伸缩又能收缩的环，并在其周长周围有许多小的带刺锚。在输送之前，环安装在可膨胀的锥形输送工具的近端。折叠的扩张器-环组件向环空推进，锥体的顶端被推过阀门孔口。然后锥体被扩张，这同时将环扩张到已知直径，并迫使环变成具有相同直径的圆形，从而实现环和环的自动对准。一旦对准，简单地向前推动输送工具就可以将带刺的锚固定到组织中，并将环固定到位。然后将扩张器工具收缩并取出。在这个项目的第一阶段，我们将建立环和输送工具的功能原型，并在猪心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，以获得监管部门对手术用途的批准。同样在第二阶段，我们将开发经皮植入该装置所需的输送系统。 公共卫生相关性：该项目的目标是开发一种用于治疗扩张的、泄漏的心脏瓣膜的无缝合环状成形术。这将导致一种无需手术即可植入的瓣环成形术，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): 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.