Cardiac Ventricular Assist Catheter

心室辅助导管

• 批准号: 9985983
• 负责人: Martin Bocks
• 金额: $ 76.5万
• 依托单位: MC3, INC.
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-19 至 2023-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9985983
• 关键词: Acute; Adolescent; Adult; Assisted Circulation; Berlin; Blood; Caliber; Cannulas; Cardiac; Cardiac Output; Cardiopulmonary; Caring; Catheters; Child; Childhood; Clinical; Clinical Data; Communication; Critical Illness; Cyclic GMP; Development; Devices; Diastolic blood pressure; Engineering; European; Extracorporeal Membrane Oxygenation; FDA approved; Failure; Functional disorder; Funding; Gases; Goals; Heart; Heart Atrium; Heart failure; Hemolysis; Hypertension; Infant; Intervention; Lead; Left; Legal patent; Length; Life; Literature; Manufacturer Name; Measures; Mechanics; Medical Device; Methods; Michigan; Molds; Monitor; Myocardial; Organ; Output; Oxygen; Pathway interactions; Patients; Pediatrics; Performance; Phase; Population; Population Analysis; Postoperative Period; Price; Puncture procedure; Recovery; Registries; Regulation; Respiratory Failure; Risk; Risk Factors; Safety; Savings; Side; Surgical Decompression; System; Technology; Testing; Translating; Transplantation; Universities; Ventricular; Weaning; Work; X-Ray Computed Tomography; aged; biological systems; cost; design; engineering design; experience; improved; in vivo; medical specialties; member; mortality; off-label use; pediatric patients; pressure; success; thrombogenesis; vascular injury; ventricular assist device; verification and validation

ABSTRACT Extracorporeal membrane oxygenation (ECMO) use continues to increase as a supportive measure for cardio-respiratory failure. Pediatric patients with severe, acute left ventricular (LV) systolic dysfunction are often supported with venoarterial (VA) ECMO as a short-term bridge to recovery, transplant or a ventricular assist device (VAD). ECMO provides temporary gas exchange and increased cardiac output to end organs. Lack of egress of blood from the LV can lead to over-distension and elevated LV end diastolic pressure (LVEDP), which reduces myocardial oxygen delivery and recovery. The risk of progressive increase in left- sided filling pressures needs to be monitored closely to avoid the deleterious effects of left-heart distention. Left ventricular distention in patients with profoundly reduced left ventricular contractility is a major risk factor for poor myocardial recovery and failure to wean from ECMO. Mechanical decompression of the left-heart during ECMO is sometimes required, as a life-saving intervention. For patients who do not have open access to the heart for surgical decompression (i.e. post-operative cardiac patients), left ventricular decompression is most commonly accomplished by percutaneous transseptal puncture followed by either septostomy, placement of a drain device to keep the atrial communication patent, and placement of a pVAD such as Impella 2.5 which is only available for adults, is hemolytic, and is extremely expensive. Due to the lack of an FDA-approved device for this indication, options for decompression represent off-label use, and none of these devices is designed for pediatrics. The goal of this project is to design, test, and produce a line of pediatric and adult left heart decompression catheters suitable to be used in patients on VA ECMO for acute, severe LV systolic dysfunction. The MC3 InterSept™ catheter line will include lengths and diameters to cover the entire spectrum of sizes required for the pediatric population from 2 kg to fully-grown patients, for both low flow left heart decompression and high flow total ventricular assist. Phase I captured detailed design inputs for the population by analyzing pediatric CT scan data from clinical cases at The University of Michigan. User requirements were translated into design inputs/outputs by MC3's team of experienced cannula design engineers. Feasibility was established by evaluating performance of the InterSept against specific criteria unique to use in the pediatric application. With Phase II funding, the full range of InterSept will be optimized, verification/validation testing will be completed, the design will be transferred to in-house MC3 manufacturing, and FDA and CE mark submissions will be filed using the ECMO pathway in the US and the Class 3 CE Mark pathway in accordance with the new European Medical Device Regulation. We have assembled a synergistic team of experts, clinicians, marketers, manufacturers and engineers who are uniquely qualified to carry out the proposed work.

抽象的 作为一种支持措施，体外膜肺氧合 (ECMO) 的使用持续增加 患有严重、急性左心室（LV）收缩功能障碍的儿童患者。 通常由静脉动脉 (VA) ECMO 支持作为恢复、移植或心室的短期桥梁 辅助装置（VAD）提供临时气体交换并增加终末器官的心输出量。 左心室血液流出不足会导致左心室过度扩张和舒张末压升高 (LVEDP)，可减少心肌氧输送和恢复的风险逐渐增加。 需要密切监测两侧充盈压，以避免左心扩张的有害影响。 左心室收缩力严重降低的患者左心室扩张是一个主要危险因素 心肌恢复不良且未能脱离 ECMO 左心机械减压。 对于没有开放通道的患者，有时需要 ECMO 作为挽救生命的干预措施。 对于心脏进行手术减压（即术后心脏病患者），左心室减压是 最常见的是经皮房间隔穿刺，然后进行房间隔造口术、放置 引流装置以保留心房通讯专利，并放置 pVAD，例如 Impella 2.5， 仅适用于成人，具有溶血性，并且由于缺乏 FDA 批准而极其昂贵。 用于此适应症的设备，减压选项代表标签外使用，并且这些设备都不是 专为儿科设计。 该项目的目标是设计、测试和生产一系列儿童和成人左心减压产品 适合使用 VA ECMO 治疗急性、严重左心室收缩功能障碍的患者使用的导管 MC3。 InterSept™ 导管系列的长度和直径将涵盖所需的整个尺寸范围 体重从 2 公斤到成年患者的儿童群体，适用于低流量左心减压和高流量左心减压 第一阶段捕获了针对儿科人群分析的详细设计输入。 来自密歇根大学临床病例的 CT 扫描数据被转化为设计。 输入/输出由 MC3 经验丰富的插管设计工程师团队建立。 根据儿科应用特有的特定标准评估 InterSept 的性能。 二期资金，InterSept全系列将得到优化，验证/确认测试将完成， 该设计将转移到内部 MC3 制造，并将提交 FDA 和 CE 标志申请 在美国使用 ECMO 途径，并根据新的欧洲标准使用 3 级 CE 标志途径 我们组建了一支由专家、信徒、营销人员组成的协同团队， 具有执行所提议工作的独特资格的制造商和工程师。