The objective of this Phase I grant is to develop and test a compact cardiopulmonary support device (CCSD). This device pumps, transfers gas, and warms blood. The CCSD is attached to the patient via venovenous (VV) or venoarterial (VA) cannulation and supplies respiratory support like extra-corporeal membrane oxygenation (ECMO) and pulsatile cardiac support similar to a ventricular assist device. Unlike ECMO circuits, all these functions are accomplished within one compact, low-resistance device. Therefore, the CCSD has a small amount of blood contact surface area and a low-shear blood flow. This leads to low damage and activation to red blood cells, platelets, and leukocytes, allowing for respiratory support for months without infused blood products and a lower complication rate than ECMO. The device is intended to provide respiratory and, if needed, cardiac support for patients with severe acute respiratory failure or chronic pulmonary disease. The only long-term treatment for chronic pulmonary disease is lung transplantation, but the waiting list has increased 300% over the last decade. In this situation, the CCSD would i) bridge patients on the waiting list until a suitable donor organ could be found, ii) support patients with respiratory distress after transplantation, and iii) might allow for transplantation with marginal donor organs. Acute respiratory failure affects more than 150,000 people per year in the US, with mortality rates of 34-65%. For these patients, the device would allow for less aggressive mechanical ventilation, reducing ventilator induced organ failure, aiding recovery, and reducing mortality. Significant preliminary design work has been performed at the University of Michigan to arrive at a CCSD design with high gas exchange, low blood flow resistance, and a high degree of biocompatibility. Phase I will be used to fabricate that design and ensure that it meets the following feasibility specifications: the CCSD has minimal areas of stasis, the CCSD can pump and fully oxygenate up to 5 L/min of blood both in vitro and in vivo, and the CCSD can operate in vitro for one week without leaking. To test these specifications, the following specific aims will be pursued:
Specific Aim #1 : Optimize device blood flow fields using computational fluid dynamics Specific Aim #2: Fabricate CCSD prototypes for performance testing Specific Aim #3: Perform in vitro testing using glycerol to examine pumping ability of the CCSD.
Specific Aim #4 : Perform in vitro blood tests to determine CCSD gas exchange function and stasis regions Specific Aim #5: Perform in vitro, seven-day durability testing of the CCSD Specific Aim #6: Perform short-term (< 8 hr) in vivo testing of the CCSD to prove safety and efficacy.
Specific Aims 2 and 5 will be performed at MC3, Inc.
Specific Aims 1, 3, 4 and 6 will be performed at the University of Michigan.
This grant will result in the development of a novel compact cardiopulmonary support device (CCSD) that can supply both respiratory and cardiac support. The new CCSD will improve treatment options for patients with either severe acute respiratory failure or chronic pulmonary disease. ? ? ?
