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: 9328150
• 负责人: Pedro J. del Nido
• 金额: $ 66.87万
• 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 2019-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9328150
• 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; Heart; Heart Abnormalities; Heart Atrium; Heart Valves; Histologic; 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; Savings; 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; follow-up; healing; high resolution imaging; 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(由申请人提供)：这个快速跟踪STTR项目的目标是开发一种新型的心脏移植手术设备，该设备将能够在不使用体外循环(CPB)的情况下实现微创心脏不停跳修复。对于改善儿童心脏缺陷外科修复的新器械的迫切需求尚未得到满足。目前的最佳手术实践包括体外循环心内直视手术，这有发生严重不良事件的风险，或者使用大型笨重设备的跨导管手术，需要一圈组织才能保持稳定，并有后期侵蚀附近结构的风险。本提案是为了响应PAR-13-091《新生儿和儿科护理环境中使用的安全有效的仪器设备》而提交的。心脏端口TM是一种新的心脏仪器端口，它将改善可视化和心脏修复能力，并且足够小，可以用于经心脏 手术适用于所有年龄段的婴儿和儿童。第一代原型可以通过心脏插入，但手术修复部位的可视化需要使用内窥镜和相机，这些设备很重，可能会与用于修复的内窥镜手术工具相碰撞。因此，本项目的目标是集成相机和光源，以生产更符合人体工程学的先进仪器，并收集临床前测试数据，以支持人类临床评估。第一阶段，目标I-1，旨在通过优化摄像机位置、光源和心脏端口TM封套内的灯泡配置来优化心脏端口TM成像系统，以最大限度地扩大视野，提供均匀的照明，并将图像失真降至最低。该原型将在一个特征良好的台式体外猪心脏模型中进行测试。第一阶段的关键里程碑将是展示新型可视化系统提供高分辨率成像，其视野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角。第二阶段，目标II-1是将第一阶段的优化可视化系统与当前的仪器通道和冲洗系统相集成，以创建功能齐全的更小、更符合人体工程学和重量更轻的HearoPortTM原型。仪器通道吸气冲洗系统将进行优化，以清除碎片和空气，将添加密封件以分离流体和电气系统，并将在具有良好特性的体外猪心台式模型中对生成的原型进行评估。第二阶段，目标II-2是进行临床前动物试验，使用集成的功能性心脏端口TM原型来关闭实验性的房间隔缺损。测试将包括一项非GLP急性和生存试点研究，一项GLP急性研究，以及一项GLP慢性研究，为期3个月。组织学分析将评估全身栓子、缺损区的有效闭合以及心脏组织在植入和取出支架后的愈合情况 左舷。该项目的成功完成将产生GLP测试数据，这将支持510K向FDA提交申请。