Ambulatory ECMO System

动态 ECMO 系统

• 批准号: 6484355
• 负责人: PHILIP LITWAK
• 金额: $ 19.98万
• 依托单位: ENSION, INC.
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-05-01 至 2003-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6484355
• 关键词: artificial membranes; bioengineering /biomedical engineering; biomedical equipment development; blood flow measurement; blood pressure; circulatory assist; cow; extracorporeal circulation; outpatient care; oxygen consumption; respirators; respiratory oxygen; respiratory oxygenation

Ension, Inc. has developed a very efficient Active Mixing Membrane Oxygenator (AMMO) with an inherent ability to pump blood as it transfers gases. Currently, this device consists of 0.5 m2 of membrane surface area and pumps 6.0 Lpm of blood. Envsion is proposing to alter its current acute-use AMMO design to meet the needs of adult-sized patients who require long-term pulmonary support. Currently, these patients are related to the intensive care unit where they are kept sedated to minimize their oxygen requirements by preventing movement. The proposed Ambulatory ECMO System (M-AMMO, "M"=mobility) will employ coated fibers in our very efficient pump-oxygenator disc configuration and venovenous cannulation. The increased M-AMMO system efficiency will permit greater gas transfer rates than are currently available and will be compact enough to permit patients to be transferred out of the ICU. Furthermore, if M-AMMO performs as designed it may reduce or preclude the need for mechanical ventilation and its attendant morbidity. This Phase I program is designed to demonstrate the feasibility of our concept. The aims of this program are to modify our current design to meet the needs of the adult patient requiring long-term respiratory support, perform sufficient in vitro and in vivo trials to evaluate system performance and suitability for the intended use, and develop a prototype manual controller. If successful, we believe that this Ension product would gain acceptance by cardiothoracic surgeons and pulmonologists throughout the medical community. PROPOSED COMMERCIAL APPLICATIONS: Approximately 100 applications of adult ECMO are voluntarily reported to the ELSO Registry each year, with many more unreported. A device capable of providing all of the respiratory support for an ambulatory patient could offer a serious alternative to mechanical ventilation, reduce overall costs by allowing patients to be transferred to "step-down" units, and be the forerunner of an artificial lung.

Ension, Inc. 开发了一种非常高效的主动混合膜氧合器 (AMMO)，具有在传输气体时泵送血液的固有能力。 目前，该设备由 0.5 m2 的膜表面积组成，可泵送 6.0 Lpm 的血液。 Envsion 提议改变其目前急性使用的 AMMO 设计，以满足需要长期肺部支持的成人患者的需求。目前，这些患者被送往重症监护室，在那里他们被注射镇静剂，通过防止运动来最大限度地减少氧气需求。拟议的动态 ECMO 系统（M-AMMO，“M”= 移动性）将在我们非常高效的泵氧合器盘配置和静脉插管中采用涂层纤维。提高的 M-AMMO 系统效率将允许比目前可用的更高的气体转移率，并且足够紧凑以允许将患者转移出 ICU。此外，如果 M-AMMO 按设计运行，它可能会减少或消除机械通气的需要及其伴随的发病率。第一阶段计划旨在证明我们概念的可行性。该计划的目的是修改我们当前的设计，以满足需要长期呼吸支持的成年患者的需求，进行足够的体外和体内试验以评估系统性能和预期用途的适用性，并开发原型手动控制器。如果成功，我们相信这款 Ension 产品将获得整个医学界心胸外科医生和肺科医生的认可。拟议的商业应用：每年约有 100 份成人 ECMO 申请自愿向 ELSO 登记处报告，还有更多未报告。一种能够为流动患者提供所有呼吸支持的设备可以为机械通气提供重要的替代方案，通过允许患者转移到“降压”单位来降低总体成本，并成为人工肺的先驱。