Tip geometry and placement of rotary blood pump inflow and outflow cannulae influence the dynamics of flow within the ventricle and aortic branch. Cannulation, therefore, directly influences the potential for thrombus formation and end-organ perfusion during ventricular assist device (VAD) support or cardiopulmonary bypass (CPB). The purpose of this study was to investigate the effect of various inflow/outflow cannula tip geometries and positions on ventricular and greater vessel flow patterns to evaluate ventricular washout and impact on cerebral perfusion. Transparent models of a dilated cardiomyopathic ventricle and an aortic branch were reconstructed from magnetic resonance imaging data to allow flow measurements using particle image velocimetry (PIV). The contractile function of the failing ventricle was reproduced pneumatically, and supported with a rotary pump. Flow patterns were visualized around VAD inflow cannulae, with various tip geometries placed in three positions in the ventricle. The outflow cannula was placed in the subclavian artery and at several positions in the aorta. Flow patterns were measured using PIV and used to validate an aortic flow computational fluid dynamic study. The PIV technique indicated that locating the inflow tip in the left ventricular outflow tract improved complete ventricular washout while the tip geometry had a smaller influence. However, side holes in the inflow cannula improved washout in all cases. The PIV results confirmed that the positioning and orientation of the outflow cannula in the aortic branch had a high impact on the flow pattern in the vessels, with a negative blood flow in the right carotid artery observed in some cases. Cannula placement within the ventricle had a high influence on chamber washout. The positioning of the outflow cannula directly influences the flow through the greater vessels, and may be responsible for the occasional reduction in cerebral perfusion seen in clinical CPB.

The most common technical complication during ECMO is clot formation. A large clot inside a membrane oxygenator reduces effective membrane surface area and therefore gas transfer capabilities, and restricts blood flow through the device, resulting in an increased membrane oxygenator pressure drop (dpMO). The reasons for thrombotic events are manifold and highly patient specific. Thrombus formation inside the oxygenator during ECMO is usually unpredictable and remains an unsolved problem. Clot sizes and positions are well documented in literature for the Maquet Quadrox-i Adult oxygenator based on CT data extracted from devices after patient treatment. Based on this data, the present study was designed to investigate the effects of large clots on purely technical parameters, for example, dpMO and gas transfer. Therefore, medical grade silicone was injected into the fiber bundle of the devices to replicate large clot positions and sizes. A total of six devices were tested in vitro with silicone clot volumes of 0, 30, 40, 50, 65, and 85 mL in accordance with ISO 7199. Gas transfer was measured by sampling blood pre and post device, as well as by sampling the exhaust gas at the devices' outlet at blood flow rates of 0.5, 2.5, and 5.0 L/min. Pre and post device pressure was monitored to calculate the dpMO at the different blood flow rates. The dpMO was found to be a reliable parameter to indicate a large clot only in already advanced "clotting stages." The CO concentration in the exhaust gas, however, was found to be sensitive to even small clot sizes and at low blood flows. Exhaust gas CO concentration can be monitored continuously and without any risks for the patient during ECMO therapy to provide additional information on the endurance of the oxygenator. This may help detect a clot formation and growth inside a membrane oxygenator during ECMO even if the increase in dpMO remains moderate.

The jet of the outflow cannula is a potential risk for patients undergoing cardiopulmonary bypass (CPB), because increased jet velocities lead to altered flow conditions and might furthermore mobilize atherosclerotic plaques from calcified aortas. The cannula jet is therefore among the main reasons for cerebral hypoxia and stroke in CPB patients. In the past, we developed a validated computational fluid dynamics (CFD) model to analyze flow conditions during CPB as dependent on cannulation and support modalities. This model is now applied to develop a novel CPB outflow cannula to reduce the jet effect and increase cerebral blood flow. The Multi-Module Cannula (MMC) is based on a generic elbow cannula that was iteratively improved. It features an inner wall to smoothly guide the blood as well as an elliptically shaped outlet diffuser. During standard CPB conditions of 5 L/min, the pressure drop over the MMC is 61 mm Hg, compared with 68 mm Hg with a standard cannula. The maximum velocities are decreased from 3.7 m/s to 3.3 m/s. In the cannula jet of the MMC, the velocities are reduced further, down to 1.6 m/s. The cerebral blood flow is typically reduced during CPB. Using the MMC, however, it reaches almost physiological values at 715 mL/min. These results suggest that the MMC outperforms standard CPB cannulas. Further design improvements and improved insertion techniques are under consideration.

Extracorporeal membrane oxygenation (ECMO) is a well-established therapy for several lung and heart diseases in the field of neonatal and pediatric medicine (e.g., acute respiratory distress syndrome, congenital heart failure, cardiomyopathy). Current ECMO systems are typically composed of an oxygenator and a separate nonpulsatile blood pump. An oxygenator with an integrated pulsatile blood pump for small infant ECMO was developed, and this novel concept was tested regarding functionality and gas exchange rate. Pulsating silicone tubes (STs) were driven by air pressure and placed inside the cylindrical fiber bundle of an oxygenator to be used as a pump module. The findings of this study confirm that pumping blood with STs is a viable option for the future. The maximum gas exchange rate for oxygen is 48mL/min/L(blood) at a medium blood flow rate of about 300mL/min. Future design steps were identified to optimize the flow field through the fiber bundle to achieve a higher gas exchange rate. First, the packing density of the hollow-fiber bundle was lower than commercial oxygenators due to the manual manufacturing. By increasing this packing density, the gas exchange rate would increase accordingly. Second, distribution plates for a more uniform blood flow can be placed at the inlet and outlet of the oxygenator. Third, the hollow-fiber membranes can be individually placed to ensure equal distances between the surrounding hollow fibers.

Current hollow fiber membrane lungs feature a predominantly straight blood path length across the fiber bundle, resulting in limited oxygen transfer efficiency due to the diffusion boundary layer effect. Using computational fluid dynamics and optical flow visualization methods, a hollow fiber membrane lung was designed comprising unique concentric circular blood flow paths connected by gates. The prototype lung, comprising a fiber surface area of 0.28 m2, has a rated flow of 2 L/min and the oxygenation efficiency is 357 mL/min/m2. The CO2 clearance of the lung is 200 mL/min at the rated blood flow. Given its high gas transfer efficiency, as well as its compact size, low priming volume, and propensity for minimal thrombogenicity, this lung design has the potential to be used in a range of acute and chronic respiratory support applications, including providing total respiratory support for infants and small children and CO2 clearance in adults.

Computational fluid dynamics (CFD) is used to simulate blood flow inside the fiber bundles of oxygenators. The results are interpreted in terms of flow distribution, e.g., stagnation and shunt areas. However, experimental measurements that provide such information on the local flow between the fibers are missing. A transparent model of an oxygenator was built to perform particle image velocimetry (PIV), to perform the experimental validation. The similitude theory was used to adjust the size of the PIV model to the minimal resolution of the PIV system used (scale factor 3.3). A standard flow of 80 mL/min was simulated with CFD for the real oxygenator and the equivalent flow of 711 mL/min, according to the similitude theory, was investigated with PIV. CFD predicts the global size of stagnation and shunt areas well, but underestimates the streamline length and changes in velocities due to the meandering flow around the real fibers in the PIV model. Symmetrical CFD simulation cannot consider asymmetries in the flow, due to manufacturing-related asymmetries in the fiber bundle. PIV could be useful for validation of CFD simulations; measurement quality however must be improved for a quantitative validation of CFD results and the investigation of flow effects such as tortuosity and anisotropic flow behavior.

Children with end-stage lung failure awaiting lung transplant would benefit from improvements in artificial lung technology allowing for wearable pulmonary support as a bridge-to-transplant therapy. In this work, we designed, fabricated, and tested the Pediatric MLung-a dual-inlet hollow fiber artificial lung based on concentric gating, which has a rated flow of 1 L/min, and a pressure drop of 25 mm Hg at rated flow. This device and future iterations of the current design are designed to relieve pulmonary arterial hypertension, provide pulmonary support, reduce ventilator-associated injury, and allow for more effective therapy of patients with end-stage lung disease, including bridge-to-transplant treatment. Keywords extracorporeal life support; hollow fiber oxygenator; wearable artificial lung One in five children with end-stage lung failure (ESLF) die while awaiting transplant. 1 Hollow fiber oxygenators or artificial lungs (ALs) are commonly used to provide pulmonary support in acute and bridge-to-transplant applications. In these devices, blood flows around a bundle of hollow fibers, while a sweep gas supplied to the fibers' lumens facilitates gas transfer via diffusion through the fiber wall. The benefits of a particular AL depend on the design properties and engineering of the AL, and device development must be thoughtfully targeted to the intended patient population to achieve optimal results. In this work, we design, fabricate, and test the performance of a paracorporeal, pumpless device intended for pediatric patients. This device, called the "Pediatric MLung," can be used as a bridge to transplant for children with ESLF.

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