Millipede Percutaneous Annuloplasty Ring

描述（由申请人提供）：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，其减小扩张的瓣环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瓣膜的技术。其中，Millipede概念是唯一可以进行真正的环成形术的器械。这个概念使用一个可以在径向力下膨胀和收缩的环，并且在其周边有许多小倒刺锚。植入后，一种新型的锁定机制将环保持在所需的直径。植入过程首先通过将输送工具（一个过大的金属丝“篮”）插入瓣环中来进行。该金属丝篮的直径大于瓣环，但足够柔韧以符合瓣环尺寸，这允许用户“找到”瓣环组织，而不管瓣环的尺寸或形状如何。一旦被放置在瓣环中，丝线提供一系列轨道或递送路径，环在该轨道或递送路径上递送。结果是环和瓣环的自动对准。一旦对准，简单地向前推动环将倒钩锚钉驱动到组织中并将环固定到位。然后将篮子收缩并取出。在该项目的第二阶段，我们将通过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成形环进行体外耐久性试验后，我们将在动物体内进行经皮植入。 公共卫生相关性：本项目的目标是开发一种用于治疗扩张、泄漏心脏瓣膜的无缝线瓣环成形术环。这将产生一种无需手术即可植入的瓣膜成形环，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.