Cardiac Ventricular Assist Catheter

摘要 体外膜氧合(ECMO)的使用继续增加，作为一种支持措施 心肺衰竭。患有严重急性左心收缩功能不全的儿童患者有 通常由静脉动脉(VA)ECMO支持，作为通往康复、移植或脑室的短期桥梁 辅助装置(VAD)。ECMO为末端器官提供临时气体交换和增加心输出量。 左室缺血可导致过度扩张和左室舒张末期压升高。 (LVEDP)，这会降低心肌氧输送和恢复。左心功能进行性增加的风险- 需要密切监测侧向充盈压力，以避免左心扩张的有害影响。 严重降低左心室收缩能力的患者的左心室扩张是一个主要危险因素 因心肌恢复不佳和ECMO脱机失败。左心机械减压术 在ECMO期间，有时需要作为挽救生命的干预措施。对于没有开放访问权限的患者 对于外科手术减压的心脏(即手术后的心脏病患者)，左心室减压是 最常见的方法是经皮经鼻中隔穿刺术，然后行鼻中隔造口术、放置 放置诸如Impella 2.5之类的PVAD，其 只有成年人才能使用，是溶血性的，而且非常昂贵。由于缺乏FDA批准的 对于这一指示，解压缩选项代表非标签使用，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术。 适用于接受VA ECMO治疗的急性严重左心室收缩功能障碍患者使用的导管。MC3 InterSept™导管系列将包括长度和直径，以覆盖所需的所有尺寸范围 儿童人口从2公斤到成年患者，既有低流量的左心减压，也有高流量的左心 流动全脑室辅助。第一阶段通过分析儿科患者获取详细的总体设计输入 密歇根大学临床病例的CT扫描数据。将用户需求转化为设计 输入/输出由MC3的S团队由经验丰富的套管设计工程师组成。可行性通过以下方式确定 对照儿科应用中使用的特定标准评估InterSept的性能。使用 第二阶段资金，将优化InterSept的全部范围，完成验证/验证测试， 设计将被转移到内部的MC3制造，并将提交FDA和CE标志 根据新的欧洲标准，使用美国的ECMO途径和3类CE标志途径 医疗器械法规。我们组建了一个由专家、临床医生、营销人员组成的协同团队， 唯一有资格执行拟议工作的制造商和工程师。

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.