CardioPort to Enable Intracardiac Beating Heart and Minimally Invasive Open Heart Surgery

CardioPort 可实现心内跳动心脏和微创心脏直视手术

• 批准号: 9138147
• 负责人: Pedro J. del Nido
• 金额: $ 22.49万
• 依托单位: NIDO SURGICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-08-15 至 2019-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9138147
• 关键词: Ablation; Acute; Age; Air; Anatomy; Animal Testing; Area; Atrial Fibrillation; Atrial Heart Septal Defects; Boston; Cardiac; Cardiac Surgery procedures; Cardiopulmonary Bypass; Caring; Catheters; Chest; Child; Childhood; Chronic; Clinical; Complex; Data; Defect; Devices; Embolism; Endocardium; Endoscopes; Engineering; Excision; Family suidae; Flushing; Future; Generations; Goals; Healed; Heart; Heart Abnormalities; Heart Atrium; Heart Valves; Human; Image; Imagery; Infant; Intracardiac abnormalities; Legal patent; Length; Lesion; Life; Light; Lighting; Liquid substance; Mechanics; Methods; Mitral Valve; Mitral Valve Prolapse; Modeling; Morbidity - disease rate; Neonatal; Operative Surgical Procedures; Optics; Outcome; Pediatric Hospitals; Phase; Pilot Projects; Positioning Attribute; Preclinical Testing; Procedures; Recovery; Regulatory Affairs; Resolution; Risk; Safety; Serious Adverse Event; Site; Small Business Technology Transfer Research; Source; Stroke; Structure; Suction; Surface; Surgical Instruments; Surgical incisions; System; Techniques; Testing; Tissues; Tricuspid valve structure; Ventricular Septal Defects; auricular appendage; cardiac repair; commercialization; design; ergonomics; follow-up; healing; high risk; imaging system; improved; improved functioning; improved outcome; in vivo; instrument; instrumentation; light weight; minimally invasive; mortality; novel; pre-clinical; product development; prototype; public health relevance; repaired; research clinical testing; response; seal; septal defect; tool

 DESCRIPTION (provided by applicant): The goal of this Fast Track STTR project is to develop a novel CardioPortTM surgical device that will enable minimally invasive beating heart repair without use of cardiopulmonary bypass (CPB). There is a critical unmet need for new instruments to improve the surgical repair of heart defects in children. Current best surgical practices involve either open-heart surgery with CPB, which has a risk for serious adverse events, or trans-catheter procedures with large bulky devices that require a rim of tissue for stability, and have a risk of late erosion into nearby structures. This proposal is submitted in response to PAR-13-091, "Safe and Effective Instruments and Devices for Use in Neonatal and Pediatric Care Settings." CardioPortTM is a novel cardiac instrumentation port that will improve visualization and cardiac repair capabilities, and that is small enough to be used in trans-cardiac procedures in infants and children of all ages. The first-generation prototype enables trans-cardiac insertion but visualization of the surgical repair site requires use of an endoscope and camera, which are heavy and can collide with endoscopic surgical tools used for repair. Therefore, the objective of this project is to integrate a camera and light source to produce a more ergonomically advanced instrument, and collect preclinical testing data to support human clinical evaluation. Phase I, Aim I-1, is to optimize the CardioPortTM imaging system by optimizing the camera position, light source and optical bulb configuration within the CardioPortTM envelope to maximize field of view, provide uniform illumination, and minimize image distortion. The prototype will be tested in a well characterized benchtop ex vivo porcine cardiac model. The key milestone from Phase I will be demonstration that the novel visualization system provides high-resolution imaging with a field of view that includes the point of contact between the target tissue and the optical bulb, and a view of the instrument tip emerging from the channel. Phase II, Aim II-1 is to integrate the optimized visualization system from Phase I with the current instrument channel and flush system to create a fully functional smaller, more ergonomic, and light weight CardioPortTM prototype. The instrument channel suction flush system will be optimized to remove debris and air, a seal will be added to separate the fluidic and electrical systems, and the resulting prototype will be evaluated in a well- characterized ex vivo pig heart bench-top model. Phase II, Aim II-2 is to conduct pre-clinical animal tests of the use of the integrated functional CardioPortTM prototype to close experimental atrial septal defects. Testing will include a non-GLP acute and survival pilot study, a GLP acute study, and a GLP chronic study with 3 months of follow up. Histological analysis will assess systemic emboli, effective closure of the defect, and healing of the heart tissue after insertion and removal of the port. Successful completion of this project will result in GLP testing data that that will support 510K filing with the FDA.

 描述（由适用提供）：这个快速轨道STTR项目的目的是开发一种新颖的CardioPortTM手术设备，该设备将无需使用心肺旁路（CPB）即可微创跳动心脏修复。对于改善儿童心脏缺陷的外科手术修复的新工具的需求至关重要。当前的最佳外科手术方法涉及使用CPB进行开心手术，该手术有严重的逆境事件的风险，或具有大量笨重设备的跨性能手术，需要大量的组织才能稳定，并且可能会遭受晚期侵蚀的风险。该提案是根据Par-13-091提交的，“安全有效的工具和设备，用于新生儿和小儿护理环境”。 CardioPortTM是一个新颖的心脏仪器端口，它将提高可视化和心脏修复功能，并且足够小，可用于跨性别者 各个年龄段的婴儿和儿童的程序。第一代原型可实现跨心脏插入，但是手术修复部位的可视化需要使用内窥镜和相机，这些内窥镜和摄像头可能很重，可以与用于维修的内窥镜外科手术工具相撞。因此，该项目的目的是集成一个相机和光源以生成更符合人体工程学的仪器，并收集临床前测试数据以支持人类的临床评估。 A阶段AIM I-1是通过优化CardioPortTM信封内的相机位置，光源和光灯泡配置来优化CardioPortTM成像系统，以最大程度地提高视场，提供均匀的照明，并最大程度地减少图像失真。该原型将在表征良好的台式式猪心脏模型中进行测试。第一阶段的关键里程碑将证明，新型可视化系统提供了具有视野的高分辨率成像，其中包括目标组织和光学灯泡之间的接触点，以及从通道中出现的仪器尖端的视图。 II阶段，AIM II-1是将I阶段的优化可视化系统与当前的仪器通道和冲洗系统整合在一起，以创建功能较小，更符合人体工程学和轻质的CardioPortTM原型。仪器通道任务齐平系统将被优化以除去碎屑和空气，将添加密封以分离流体和电气系统，并将在特征良好的外体猪心脏台式模型中评估所得的原型。 II阶段，AIM II-2是为使用综合功能性心porttm原型进行临床前动物测试来关闭实验性心房间隔缺陷。测试将包括一项非GLP急性和生存试验研究，GLP急性研究以及3个月随访的GLP慢性研究。组织学分析将评估全身栓子，有效闭合缺陷以及插入和去除后心组织的愈合 港口。该项目的成功完成将导致GLP测试数据，该数据将支持FDA的510K归档。