Endovascular surgery system for atrial septal defect repair

房间隔缺损修复血管内手术系统

• 批准号: 7154272
• 负责人: Brian Jude Fill
• 金额: $ 27万
• 依托单位: ENSION, INC.
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-30 至 2009-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7154272
• 关键词: blood vessels; computer assisted patient care; computer program /software; computer system design /evaluation; congenital heart septum defect; disease /disorder model; echocardiography; electromagnetic radiation; heart /lung bypass; heart surgery; image guided surgery /therapy; magnetic field; surgery material /equipment; swine; therapy design /development; ultrasonography; veins

DESCRIPTION (provided by applicant): Atrial septal defect (ASD) is one of the most common congenital heart defects found in pediatrics and adults. Surgical repair of ASD has been considered the gold standard for correction of ASD, however, to avoid complications associated with open-chest operation and cardiopulmonary bypass, transcatheter occlusion implant devices have been developed and are gaining clinical acceptance. While implant occlusion is less invasive than traditional surgery with shorter hospital stay and less scarring, a significant complication rate is associated with occlusion implants, including the erosion or puncture of implant structures through adjacent cardiac tissues. The investigators propose a system for endovascular-based surgical correction of atrial septal defect. The Phase I catheter-based system would achieve tissue stabilization, surgical ASD patch deployment and suture fixation capabilities and replicate traditional surgical correction of ASD via percutaneous access. As a result, our proposed system would eliminate the need for open-chest procedures and cardiopulmonary bypass (CPB). Furthermore, the this system will utilize a surgical patch comprised only of a polyester patch and suture material leaving no rigid metal structures in the body, therefore mitigating the risk of device related puncture or erosion. In this Phase I effort, a catheter-based system will be fabricated, including a custom surgical patch, a removable nitinol patch deployment frame, a transseptal suture tool, and a custom surgical knot pusher. Electromagnetic (EM) tracking of the Phase I tools and a transesophageal echo (TEE) probe will be used for navigation. We will develop a custom user interface to render TEE images and surgical tool positions in a virtual environment in real time. An in vitro test fixture will be fabricated to hold an excised abattoir porcine septum and impart a physiologic LA to RA pressure gradient. The fixture will include a simulated esophagus to facilitate TEE probe introduction and in vitro testing of the Phase I surgical tools using the EM-based navigation system. Following in vitro tests and refinement of tool designs, the investigators will perform six ASD corrections in adult pigs. Park Blade Catheters will be used to create ASD and subsequent ASD repair will be performed using Phase I prototype systems. Three acute procedures will be performed (2 hour post-op observation prior to sacrifice) to assess basic functionality of the system. Three recovery procedures will be performed (21 day post-op observation) to assess the long term custom surgical patch performance and safety. Successful development of the proposed tools could serve as a platform system for the expansion of endovascular procedures such as surgical manipulations of the left atrial appendage or failing mitral valve. An atrial septal defect (ASD) is a malformation in the heart which historically has been corrected with open- heart surgery. To avoid invasive surgery, ASD can be plugged with small implants inserted through a cut in the leg and anchored in the heart; however, these implants have been known to cause additional damage to surrounding heart tissue. A miniature device will be developed which can perform surgery on ASD through the same small cut in the leg without the need for implants or open-heart surgery.

描述（由申请人提供）：心房间隔缺陷（ASD）是儿科和成人最常见的先天性心脏缺陷之一。但是，ASD的手术修复被认为是校正ASD的黄金标准，以避免与开胸手术和心肺旁路相关的并发症，已开发出经导管遮挡植入器设备并获得临床接受。虽然植入物阻塞的侵入性比传统手术较短，而且住院时间较短，而疤痕较少，但显着的并发症发生率与遮挡植入物有关，包括通过相邻的心脏组织侵蚀或穿刺植入物结构。研究人员提出了一个基于内血管内膜缺陷的基于血管内的手术校正的系统。基于I期导管的系统将实现组织稳定，手术ASD贴片部署和缝合固定功能，并通过经皮入路复制ASD的传统手术校正。结果，我们提出的系统将消除对开胸手术和心肺旁路（CPB）的需求。此外，该系统将使用仅由聚酯贴片和缝合材料组成的手术贴片，使体内没有刚性金属结构，因此减轻了与设备相关的穿刺或侵蚀的风险。在此I阶段的工作中，将制造基于导管的系统，包括定制的外科补丁，可移动的Nitinol贴片部署框架，transseptal缝合工具和定制的手术结推器。 I期工具的电磁（EM）跟踪将用于导航。我们将开发一个自定义用户界面，以实时在虚拟环境中渲染T恤图像和手术工具位置。将制造一个体外测试固定装置，以容纳切除的屠宰场猪隔膜，并将生理学LA赋予RA压力梯度。该固定装置将包括模拟食道，以促进TEE探针介绍和使用基于EM的导航系统对I期手术工具进行体外测试。经过体外测试和工具设计的完善，研究人员将在成年猪中进行六项ASD校正。公园刀片导管将用于创建ASD，随后将使用I期原型系统进行ASD维修。将执行三个急性程序（在牺牲前2小时观察）以评估系统的基本功能。将执行三个恢复程序（2天后观察），以评估长期自定义手术补丁的性能和安全性。拟议工具的成功开发可以作为扩展血管内手术的平台系统，例如左心脏附件的手术操作或二尖瓣失败。心房缺陷（ASD）是心脏中的一种畸形，历史上已经通过心脏心脏手术进行了纠正。为避免侵入性手术，可以用插入腿切割并锚定在心脏的小植入物插入ASD；但是，已知这些植入物会对周围的心脏组织造成额外的损害。将开发一个微型装置，可以通过腿部相同的小切口在ASD上进行手术，而无需植入或心脏直视手术。