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（由申请人提供）：该 Fast Track STTR 项目的目标是开发一种新型 CardioPortTM 手术设备，该设备将能够在不使用体外循环 (CPB) 的情况下实现微创跳动心脏修复。对于改善儿童心脏缺陷手术修复的新仪器的迫切需求尚未得到满足。目前最好的外科手术包括采用体外循环的心脏直视手术，这种手术有发生严重不良事件的风险，或者采用大型笨重装置的经导管手术，需要组织边缘来保持稳定性，并且有后期侵蚀附近结构的风险。该提案是为了响应 PAR-13-091“新生儿和儿科护理环境中使用的安全有效的仪器和设备”而提交的。 CardioPortTM 是一种新型心脏仪器端口，可提高可视化和心脏修复能力，并且足够小，可用于跨心脏手术 适用于所有年龄段的婴儿和儿童的手术。第一代原型可以进行经心脏插入，但手术修复部位的可视化需要使用内窥镜和摄像头，这些设备很重，可能会与用于修复的内窥镜手术工具发生碰撞。因此，该项目的目标是集成摄像头和光源，生产出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体临床评估。第一阶段的目标 I-1 是通过优化 CardioPortTM 外壳内的相机位置、光源和灯泡配置来优化 CardioPortTM 成像系统，以最大化视野、提供均匀照明并最大限度地减少图像失真。该原型将在特征良好的台式离体猪心脏模型中进行测试。第一阶段的关键里程碑将是证明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灯泡之间的接触点，以及从通道中出现的仪器尖端的视图。第二阶段的目标 II-1 是将第一阶段优化的可视化系统与当前的仪器通道和冲洗系统集成，以创建功能齐全、更小、更符合人体工程学且重量轻的 CardioPortTM 原型。仪器通道抽吸冲洗系统将被优化以去除碎片和空气，将添加密封件以分隔流体和电气系统，并且将在特征良好的离体猪心脏台式模型中对所得原型进行评估。第二阶段，目标 II-2 是使用集成功能 CardioPortTM 原型来封闭实验性房间隔缺损进行临床前动物试验。测试将包括一项非 GLP 急性和生存试点研究、一项 GLP 急性研究和一项带 3 个月随访的 GLP 慢性研究。组织学分析将评估系统性栓塞、缺损的有效闭合以及插入和取出栓塞后心脏组织的愈合情况。 港口。该项目的成功完成将产生 GLP 测试数据，这些数据将支持向 FDA 提交 510K 申请。