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.