Cardiac Ventricular Assist Catheter

摘要 体外膜肺氧合（ECMO）的使用继续增加，作为一种支持性措施， 心肺衰竭严重急性左心室（LV）收缩功能障碍的儿科患者， 通常使用静脉动脉（VA）ECMO作为恢复、移植或心室 辅助设备（VAD）。ECMO提供暂时的气体交换和增加心脏输出到终末器官。 缺乏血液从左心室流出可导致过度扩张和左心室舒张末期压升高 （LVEDP），其减少心肌氧输送和恢复。左心室增大的风险- 需要密切监测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的左心室扩张是一个主要的危险因素 因为心肌恢复不佳和无法脱离体外膜肺氧合左心机械减压术 在ECMO期间，有时需要作为挽救生命的干预措施。对于没有开放获取的患者 对于心脏手术减压（即术后心脏病患者），左心室减压是 最常见的方法是经皮经中隔穿刺，然后进行中隔造口术、放置 引流装置以保持心房连通通畅，并放置pVAD，如Impella 2.5， 仅适用于成年人，具有溶血性，并且非常昂贵。由于缺乏FDA批准的 用于该适应症的器械，解压选项代表标签外使用，这些器械均不适用于 专为儿科设计 这个项目的目标是设计、测试和生产一条儿童和成人左心减压线 适用于因急性、重度LV收缩功能障碍而接受VA ECMO的患者的导管。关于MC 3 InterSept™导管系列将包括长度和直径，以涵盖所需的整个尺寸范围， 从2 kg到完全发育的患者的儿科人群，对于低流量左心减压和高流量左心减压， 流量全心室辅助。第一阶段通过分析儿科患者， 来自密歇根大学临床病例的CT扫描数据。用户需求转化为设计 MC 3经验丰富的插管设计工程师团队提供的输入/输出。可行性是由 根据儿科应用中使用的特定标准评价InterSept的性能。与 第二阶段资金，InterSept的全系列将得到优化，验证/确认测试将完成， 该设计将被转移到内部的MC 3制造，并提交FDA和CE认证申请 在美国使用ECMO途径，根据新的欧洲 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.