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。植入后，一种新的锁定机构将环保持在所需的直径。植入过程是通过首先将输送工具--一个超大钢丝“篮子”--插入到环空中来执行的。这个钢丝篮子的直径比环状的大，但柔韧性足以符合环形的尺寸，这使得使用者无论环状组织的大小或形状如何，都可以找到环状组织。一旦放置在环空中，钢丝就提供了一系列轨道或输送路径，环通过这些轨道或输送路径进行输送。其结果是环和环自动对准。一旦对准，简单的向前推动环就可以将带刺的锚固定到组织中，并将环固定到位。然后将篮子收缩并移走。在这个项目的第二阶段，我们将通过外科手术将第一阶段开发的原型植入动物体内。在开发出功能齐全的输送系统并对环进行体外耐久性测试后，我们将在动物身上进行经皮植入。 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. After implant, a novel locking mechanism holds the ring at the desired diameter. The implantation process is performed by first inserting the delivery tool, an oversized wire "basket", into the annulus. This wire basket is larger than the annulus in diameter, but flexible enough to conform to the annular dimensions, which allows the user to "find" the annular tissue regardless of the size or shape of the annulus. Once placed in the annulus, the wires provide a series of rails, or delivery paths, over which the ring is delivered. The result is an automatic alignment of the ring and the annulus. Once aligned, a simple forward push of the ring drives the barbed anchors into the tissue and secures the ring in place. The basket is then contracted down and removed. In Phase II of this project we will surgically implant the prototypes developed in Phase I in animals. After developing a fully functional delivery system and conducting in vitro durability testing on the ring, we will perform percutaneous implants in animals. 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.