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）：房间隔缺损（房间隔缺损）是儿科和成人最常见的先天性心脏缺陷之一。ASD的手术修复一直被认为是矫正ASD的金标准，然而，为了避免与开胸手术和体外循环相关的并发症，经导管闭塞植入装置已经被开发出来并获得临床认可。虽然种植体闭塞比传统手术侵入性小，住院时间短，瘢痕较少，但闭塞种植体的并发症发生率很高，包括通过邻近心脏组织侵蚀或穿刺种植体结构。研究人员提出了一种基于血管内的房间隔缺损手术矫正系统。基于导管的I期系统将实现组织稳定、手术ASD贴片部署和缝合固定能力，并复制传统的经皮ASD手术矫正。因此，我们提出的系统将消除开胸手术和体外循环（CPB）的需要。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，在体内不留刚性金属结构，因此降低了与设备相关的穿刺或侵蚀的风险。在第一阶段的工作中，将制造一个基于导管的系统，包括一个定制的手术贴片，一个可移动的镍钛诺贴片部署框架，一个跨隔膜缝合工具和一个定制的手术打结器。第一阶段工具的电磁（EM）跟踪和经食管回声（TEE）探头将用于导航。我们将开发一个定制的用户界面，在虚拟环境中实时渲染TEE图像和手术工具位置。将制造一个体外测试夹具来容纳切除的屠宰场猪隔膜，并赋予生理LA到RA的压力梯度。该装置将包括一个模拟食管，以促进TEE探针的引入，并使用基于em的导航系统对第一阶段手术工具进行体外测试。在体外测试和改进工具设计之后，研究人员将在成年猪身上进行6次ASD矫正。Park Blade导管将用于创建ASD，随后的ASD修复将使用第一阶段原型系统进行。将进行三次急性手术（术后牺牲前2小时观察）以评估系统的基本功能。将进行三次恢复程序（术后21天观察），以评估长期定制手术贴片的性能和安全性。所提出的工具的成功开发可以作为血管内手术扩展的平台系统，如左心房附件或二尖瓣衰竭的手术操作。房间隔缺损（ASD）是一种心脏畸形，历来都是通过心脏直视手术来矫正的。为了避免侵入性手术，ASD可以通过腿部切口插入小植入物并固定在心脏中；然而，已知这些植入物会对周围的心脏组织造成额外的损害。一种微型装置将被开发出来，它可以通过腿上同样的小切口对自闭症谱系障碍进行手术，而不需要植入物或开胸手术。