Development of an ultracompact integrated heart-lung assist device for long-term cardiopulmonary support

本研究的目的是开发一种新型的集成心脏辅助设备，它不仅是一个简单而实用的超紧凑型心脏辅助系统，但也是一个用于长期桥梁到肺或心脏移植的系统。该设备包括一个中央泵和一个人工肺，它位于泵周围，可以在一个全合一系统中运行。一种特殊的聚烯烃制成的空心纤维膜，在任何微生物都是盲目地准备等离子体破裂，以便在预定用途中使用并使之启用预主安装，已经开发和部署。这种空心纤维被设计成具有一个小的直径，比一个普通的直径要大得多，可以在一个外包装的血液流动时尚中进行有效的可靠混合。测试午餐将在3个月后保留相同的薄膜上良好的气体交换功能。与血液接触的表面已经被处理，与新开发的、一致的肝素结合，以改善良好的抗细胞生成性。Heparin绑定测试午餐可以连续地进行完美的没有系统性的抗干扰，在36天内使用山羊进行的三维旁路慢性动物研究。第三次迭代原型装置（直径： 13厘米，高度： 5厘米，膜区域： 1.5米D12 D1，启动体积： 165毫升）装置中通过现实化生成sprinkler样的血液流动模式从中央泵部分到具有循环定位的淋巴结人工肺部分的循环部分。在体外和体外评估研究中，设备在200毫米汞压力头上显示出5升/分钟泵输出，在5升/分钟血液流动中显示出225毫升/分钟氧和160毫升/分钟碳二氧化物转移率。我们把这个设备有潜力成为下一代的心脏病支持系统，因为它可以用来长期使用而没有系统性抗干扰。

The purpose of this research is to develop a novel integrated heart-lung assist device which is not only a simple-to-use ultra-compact cardiopulmonary support system but also a system usable for long-term bridge to lung or heart-lung transplantation. The device comprises a centrifugal pump and an artificial lung which is located around the pump to be and all-in-one system. The special polyolefin-made hollow fiber membrane, in which micropores are blind-ended to preclude plasma breakthrough in protracted use and to enable preprimed setup, was developed and employed. this hollow fiber was designed to have a smaller diameter than usual one to obtain effective convective mixing in a extracapillary blood flow fashion. Test lungs consisting of the same membrane well preserved gas-exchange function after 3 months preprimed storage. The entire blood-contacting surface is treated with newly-developed covalently heparin bonding to impart good antithrombogenicity. Heparin bonded test lungs could be continuously perfused without systemic anticoagulation for as long as 36 days in venoarterial bypass chronic animal study using goats. The third iteration prototype device (diameter: 13 cm, height: 5 cm, membrane area: 1.5 mィイD12ィエD1, priming volume: 165 ml) acquired ideal flow condition in the device by realizing sprinkler-like blood flow pattern from the centrifugal pump compartment to the cylindrical artificial lung compartment with circumferentially located diffusers. In in vitro and ex vivo evaluation studies, the device demonstrated 5 L/min pump output at 200 mm Hg pressure head, and 225 ml/min oxygen and 160 ml/min carbon dioxide transfer rates at 5 L/min blood flow. We conclude that this device has a potentiality to be the next generation cardiopulmonary support system which can be used for long-term without systemic anticoagulation.