Gas Exchange Array for Implantable Artificial Lung

描述（由申请人提供）： 自1990年以来，肺移植已成为由于慢性阻塞性肺病（COPD）、囊性纤维化（CF）、特发性肺纤维化（IPF）和肺动脉高压（PHT）等病症而导致的终末期肺衰竭患者的优选临床手术。供体器官的可用性远远低于需求，不幸的是，这一临床选择限制在每年约1 000名患者。很明显，需要用机械替代移植。为了获得临床成功，植入式人工肺必须满足无数的设计挑战。一些大学医学中心的活动针对人工肺开发的各个方面，该技术已经发展到至少有一个小组预计在未来两年内进行临床试验的地步。该系统与大多数正在开发的其他系统一样，是一种辅助装置，并使用氧气而不是环境空气作为交换气体。我们建议开发一种代表超越此类设备的关键技术。我们的紧凑型气体交换阵列具有环境空气气体交换和足够低的血液侧压降，可以使用天然心脏作为血液泵。该装置由24个子阵列组成，每个子阵列由多个中空气体交换管制成。它适合身体，阵列的顶部靠近半胸腔的顶部，底部靠近隔膜，凹形内侧面向心脏，凸形外侧面向肋骨，前侧和后侧面向半胸腔的前表面和后表面。使用现有的性能预测代码的初步分析结果是有希望的，但需要进一步证明这种创新的可行性。第I阶段将分析评价子阵列的置信设计和尺寸确定所需的血液侧扩散系数。然后，我们将使用台式测试夹具评估样本子阵列的性能，并使用所得数据来验证性能代码预测并更新代码。最后，我们将使用更新后的程式码来概念化植入式人工肺的设计。这项工作将为第二阶段的动物试验奠定基础，第二代原型尺寸合适。相关辅助器械的初步版本也将在第I1阶段开发。

DESCRIPTION (provided by applicant): Since 1990, lung transplantation has become the preferred clinical procedure for patients with end-stage lung failure due to such conditions as chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF), idiopathic pulmonary fibrosis (IPF), and pulmonary hypertension (PHT). Availability of donor organs is far less than required, and unfortunately limits this clinical option to approximately 1,000 patients per year. It is clear that mechanical alternatives to transplantation are required. To achieve clinical success, an implantable artificial lung must satisfy a myriad of design challenges. Activities at a number of university medical centers are aimed at various aspects of artificial lung development, and the technology has progressed to the point where at least one group anticipates clinical trials within the next two years. This system, as with most others in development, is a paracorporeal device, and uses oxygen rather than ambient air as the exchange gas. We propose to develop a key technology that represents an advance beyond such devices. Our compact gas exchange array features ambient air gas exchange and a bloodside pressure drop low enough to use the natural heart as the blood pump. The device consists of 24 subarrays, each made of multiple hollow gas exchange tubes. It fits into the body with the top of the array near the top of the hemi-thorax, the bottom near the diaphragm, the concave medial side facing the heart, the convex lateral side facing the ribs, and the anterior and posterior sides facing the anterior and posterior surfaces of the hemi-thorax cavity. Results of a preliminary analysis using an existing performance prediction code are promising, but further proof of the feasibility of this innovation is needed. Phase I will analytically evaluate the blood-side diffusion coefficient required for confident design and sizing of the subarrays. We will then assess the performance of sample subarrays with a bench-top test fixture and use the resulting data to validate performance code predictions and update the code. Finally, we will use the updated code to conceptualize a design for an implantable artificial lung. This work will set the stage for animal tests in Phase II with a second-generation, properly sized prototype. Preliminary versions of associated ancillary devices will also be developed in Phase I1.