Commercialization of a Simple Automatic Perfusion System for ECPR

 描述（由申请人提供）：ECMO与CPR（一种称为“ECPR”的技术）联合使用已被证明可减少中枢神经系统（CNS）损伤，改善恢复后的脑功能，并使存活至出院率高达40%。广泛采用ECPR的一个限制因素是需要一个简单的自动灌注系统，该系统本质上是安全的，并在最少的操作员干预下提供全面支持。 MC 3在SBIR资助（HL 091616）下开发，其专利技术结合在一起，形成了一个紧凑、高度便携、安全且易于使用的自动灌注系统（APS）。该器械将降低实施紧急ECPR的障碍，并促进这些手术的扩大使用，从而改善难治性心脏骤停的结局。 APS系统也被设想为心源性死亡（DCD）后抢救供体器官的工具。DCD支持和ECPR的用户要求是等同的，允许APS在扩展的体外支持领域中更广泛地应用。 在第一阶段和第二阶段，开发了一个原型，用于实验室和动物测试以及客户评估。体内研究表明，在未经治疗的心室颤动30分钟后，ECPR可恢复心脏功能。使用受控和非受控DCD动物模型进行的其他研究证实了器械功能，并证明了在长达60分钟的长时间热缺血后器官调节至移植状态。对辅助医务人员进行了MC 3系统使用培训，并协助进行动物研究，以评价系统的可用性。 该IIb期NHLBI桥接应用的目标是将I/II期开发的简单自动灌注系统推进为ECPR的商业产品。我们将收集用户的关键反馈，并整合电子产品，以提高安全性和可用性。该系统将接受完整的验证和确认测试，以准备提交监管机构。将进行体内研究，以评估器械功能和耐久性。在IIb期结束时，我们将拥有一个高度集成的心肺支持系统，用于ECPR，可全自动调节流量、氧气、CO2和温度，以支持“受控再灌注”策略，同时提供稳定的自动调节灌注。我们预计该APS器械将降低紧急ECPR的实施障碍，并将扩大这些手术的接受范围，从而大大改善ECPR结局，并在无法复苏的情况下提供更多的供体器官。

 DESCRIPTION (provided by applicant): The use of ECMO in conjunction with CPR, a technique known as "ECPR", has been shown to reduce central nervous system (CNS) damage, improve brain function after recovery, and result in survival-to-hospital- discharge rates up to 40%. A limiting factor for widespread adoption of ECPR is the need for a simple automatic perfusion system that is inherently safe, and provides full support with minimal operator intervention. Developed under SBIR funding (HL091616), MC3's patented technologies have been combined to form a compact, highly portable, safe and simple to use automatic perfusion system (APS). This device will lower the barriers for implementation of emergent ECPR and facilitate expanded use of these procedures resulting in improved outcomes for refractory cardiac arrest. The APS system is also envisioned as a tool for salvaging donor organs after cardiac death (DCD). The user requirements for DCD support and ECPR are equivalent, allowing broader application of the APS in the expanding field of extracorporeal support. In Phase I and II, a prototype was developed for use in bench and animal testing and customer evaluations. In vivo studies demonstrated restoration of cardiac function with ECPR after 30 minutes of untreated ventricular fibrillation. Additional studies with controlled and uncontrolled DCD animal models confirmed device functionality and demonstrated conditioning of organs to transplant status following extended periods of warm ischemia up to 60 minutes. Paramedical personnel were trained on the use of MC3 system, and assisted in animal studies to evaluate the usability of the system. The goal of this Phase IIb NHLBI Bridge application is to advance the simple automatic perfusion system developed in Phase I/II to a commercial product for ECPR. We will capture critical feedback from users and consolidate electronics to improve safety and usability. The system will undergo complete verification and validation testing to prepare for regulatory submission. In vivo studies will be performed to assess device functionality and durability. At the end of Phase IIb we will have a highly integrated cardio-pulmonary support system for use in ECPR with fully automated regulation of flow, oxygen, CO2 and temperature to support "controlled reperfusion" strategies, while providing stable, auto-regulated perfusion. We anticipate this APS device will lower the barriers for implementation of emergent ECPR, and will result in expanded acceptance of these procedures resulting in greatly improved ECPR outcomes and greater availability of donor organs if resuscitation is not possible.