AMBULATORY ECMO SYSTEM

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.