Advanced Cannula Development for Coronary Sinus Access

 描述（由申请人提供）：本1期STTR将开发用于冠状窦入路的新技术。冠状窦提供了独特的解剖和生理接近所有四个心腔和冠状循环。例如，冠状窦用于左心室电极导线插入，以进行双心室起搏或心脏再同步。在美国，估计每年有莫尔多于100，000例这样的植入，并且该手术是食品和药物管理局批准的用于充血性心力衰竭的治疗。然而，由于成角、瓣膜、位置不稳定、阈值差和解剖结构异常，经静脉冠状窦电极导线插入失败率为8-13%。替代方法包括通过开胸手术插入心外膜电极导线或完全推迟该治疗。通过开胸术插入心外膜电极导线是痛苦的，心力衰竭患者的恢复时间较长，并且在既往手术或心肌梗死后粘连包裹心脏时特别危险。右胸骨旁纵隔切开术是一种微创开胸术，用于胸内肿瘤的活检，已用于腔内起搏，并可允许进入右心房内的冠状窦。然而，缺乏为此目的优化的导入器。本STTR将开发三维图像配置导引器。特定目标1将在患者中使用磁共振和X射线计算机断层扫描成像来定义冠状窦插管的几何结构。将开发用于定制的、患者特定的插管设计和制造的具有成本效益的技术。Specific Aim 2将在六只麻醉猪中测试原型，以改进设计和方法。将检查可操纵导管和心内超声心动图的效用。导入器技术将被衍生，原型将可用于同情使用，并在第II阶段进一步开发。将在开发的所有阶段评估里程碑。研究小组的初步经验表明，这一STTR将产生技术进步，导致成功的商业开发。改善冠状窦通路将有助于诊断和治疗干预，包括心律失常标测和消融、微创心脏手术、微创二尖瓣手术、机械循环辅助和缩小心肌梗死面积。使用成像和组织密封剂的经皮进入技术的进一步发展最终可以将这些定制导引器的市场扩大到每年超过300，000例手术。

 DESCRIPTION (provided by applicant): This Phase 1 STTR will develop novel techniques for coronary sinus access. The coronary sinus provides unique anatomic and physiologic proximity to all four cardiac chambers and the coronary circulation. For example, the coronary sinus is used for left ventricular lead insertion for biventricular pacing or cardiac resynchronization. Mor than 100,000 such implants are estimated annually in the United States, and the procedure is Food and Drug Administration approved treatment for congestive heart failure. However, transvenous coronary sinus lead insertion fails in 8-13% of attempts because of angulation, valves, unstable locations, bad thresholds, and anomalous anatomy. Alternatives include surgical insertion of epicardial leads by thoracotomy or completely deferring this therapy. Epicardial lead insertion via thoracotomy is painful, with prolonged recovery in heart failure patients, and is particularly hazardous when adhesions encase the heart after prior surgery or myocardial infarction. Right parasternal mediastinotomy, developed for biopsy of intrathoracic tumors is a minimally invasive thoracotomy that has been used for endocardial pacing and could allow unique access to the coronary sinus inside the right atrium. However, introducers optimized for this purpose are lacking. The present STTR would develop three-dimensional image-configured introducers. Specific Aim1 will use magnetic resonance and X-ray computerized tomography imaging in patients to define geometry for coronary sinus cannulation. Cost-effective techniques for customized, patient-specific cannula design and manufacturing will be developed. Specific Aim 2 will test prototypes to refine designs and methods in six anesthetized pigs. Utility of steerable catheters and intracardiac echocardiography will be examined. Introducer technology will be derived and prototypes will be available for compassionate use and further development in Phase II. Milestones will be assessed at all stages of development. Preliminary experience of the research team suggests that this STTR will produce technical advances that will lead to successful commercial development. Improved coronary sinus access would facilitate diagnostic and therapeutic interventions including arrhythmia mapping and ablation, minimal access cardiac surgery, minimally invasive mitral valve surgery, mechanical circulatory assistance, and reduction of myocardial infarction size. Further development of percutaneous access techniques using imaging and tissue sealants could ultimately expand the market for these customized introducers to more than 300, ooo procedures annually.