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
基本信息
- 批准号:9328150
- 负责人:
- 金额:$ 66.87万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 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:
- 关键词:AblationAcuteAgeAirAnatomyAnimal TestingAreaAtrial FibrillationAtrial Heart Septal DefectsBostonCardiacCardiac Surgery proceduresCardiopulmonary BypassCaringCathetersChestChildChildhoodChronicClinicalComplexDataDefectDevicesEmbolismEndocardiumEndoscopesEngineeringExcisionFamily suidaeFlushingFutureGenerationsGoalsHeartHeart AbnormalitiesHeart AtriumHeart ValvesHistologicHumanImageImageryInfantIntracardiac abnormalitiesLegal patentLengthLesionLifeLightLightingLiquid substanceMechanicsMethodsMitral ValveMitral Valve ProlapseModelingMorbidity - disease rateNeonatalOperative Surgical ProceduresOpticsOutcomePediatric HospitalsPhasePilot ProjectsPositioning AttributePreclinical TestingProceduresRecoveryRegulatory AffairsResolutionRiskSafetySavingsSerious Adverse EventSiteSmall Business Technology Transfer ResearchSourceStrokeStructureSuctionSurfaceSurgical InstrumentsSurgical incisionsSystemTechniquesTestingTissuesTricuspid valve structureVentricular Septal Defectsauricular appendagecardiac repaircommercializationdesignfollow-uphealinghigh resolution imaginghigh riskimaging systemimprovedimproved functioningimproved outcomein vivoinstrumentinstrumentationlight weightminimally invasivemortalitynovelpre-clinicalproduct developmentprototypepublic health relevancerepairedresearch clinical testingresponsesealseptal defecttool
项目摘要
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.
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(3)
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- DOI:
10.1016/j.jtcvs.2023.04.032 - 发表时间:
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Predictive modeling of endocardial fibroelastosis recurrence in patients with congenital heart disease
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Daniel Diaz-Gil;Natalia Silva-Gomez;Sarah U. Morton;Jonathan G. Seidman;Christine E. Seidman;David Zurakowski;Steven J. Staffa;Gerald R. Marx;Sitaram M. Emani;Pedro J. del Nido;Ingeborg Friehs - 通讯作者:
Ingeborg Friehs
Pedro J. del Nido的其他文献
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{{ truncateString('Pedro J. del Nido', 18)}}的其他基金
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 - 财政年份:2016
- 资助金额:
$ 66.87万 - 项目类别:
Surgical Planning Tool for Aortic Valve Reconstruction
主动脉瓣重建手术计划工具
- 批准号:
8856326 - 财政年份:2012
- 资助金额:
$ 66.87万 - 项目类别:
Surgical Planning Tool for Aortic Valve Reconstruction
主动脉瓣重建手术计划工具
- 批准号:
8522218 - 财政年份:2012
- 资助金额:
$ 66.87万 - 项目类别:
Surgical Planning Tool for Aortic Valve Reconstruction
主动脉瓣重建手术计划工具
- 批准号:
8706947 - 财政年份:2012
- 资助金额:
$ 66.87万 - 项目类别:
Surgical Planning Tool for Aortic Valve Reconstruction
主动脉瓣重建手术计划工具
- 批准号:
8372571 - 财政年份:2012
- 资助金额:
$ 66.87万 - 项目类别:
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