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Oxygenators are a lifesaving technology used for blood oxygenation and decarboxylation in case of acute respiratory failure, chronic lung disease, and during open-heart surgery. Devices typically consist of a bundle of thousands of fibre membranes in a housing, with gas flowing inside the fibres and blood flowing in the opposite direction outside the fibres. Both ends of the fibre-membranes are fixed with an adhesive to separate gas and blood. The shape of the volume through which the blood flows is determined by the housing of the oxygenator and the internal end surfaces of the fixed ends of the fibre-membrane bundle. The traditional potting process results in a volume shape that is associated with stagnation zones, which are known to promote thrombus formation. In this study, an adapted potting process is proposed which results in a blood compartment with bevelled end faces of the glued bundle parts. Using a numerical study, we have demonstrated that the novel oxygenator design results in optimized flow conditions. [ABSTRACT FROM AUTHOR]

The study proposes a fluid simulation and analysis of oxygenated membrane fabrics for Extracorporeal Membrane Oxygenation (ECMO) by applying knitting technology from the field of textile technology. This is aimed at addressing the lack of research on the impact of the oxygenator flow field before and after knitting of oxygenated membrane fabrics. For this investigation, a commercial oxygenator was selected, featuring a polymethylpentene (PMP) hollow fiber membrane as the oxygenator membrane material, along with a knitted yarn made of a 50D/24F polyester low-elasticity filament. The knitting organization utilized warp knitting technology with a pillar stitch/weft lining structure. Through the integration of theoretical geometric modeling and finite element analysis method of flow-solid coupling, the study examined the influence of knitting on the oxygenator before and after the knitting of the PMP membrane material. Extracorporeal membrane oxygenation (ECMO) technology represents a sophisticated equipment within the domain of in vitro medical treatment. The research findings indicated that the total pressure drop in the oxygenator's flow field was 472.6 Pa for the unknitted PMP membrane and 269.4 Pa for the knitted oxygenator fabric, signifying a near 40% reduction in pressure with the knitted PMP membrane. This reduction in pressure also led to a 50% decrease in turbulence within the flow field. The maximum displacement of the knitted PMP membrane within the flow field was measured at 0.16 mm, whereas the unknitted membrane displayed a maximum displacement of 0.37 mm. The knitted PMP membrane significantly enhanced the pressure and velocity uniformity of the oxygenator's flow field, resulting in decreased stress-strain effects and improved service life of the oxygenator. In conclusion, the study illustrates that knitting the PMP membrane can substantially improve the flow field distribution of ECMO oxygenators, leading to enhanced oxygenation efficiency and membrane durability. [ABSTRACT FROM AUTHOR]

The text discusses the feasibility of developing an anticoagulation-free artificial placenta device to improve outcomes for extremely premature infants. Current oxygenation systems face challenges related to blood clotting due to large surface areas, priming volumes, and non-uniform blood flow dynamics. Design considerations for future artificial placenta devices include scaling to patient size, utilizing surface coatings, exploring pumpless circuits, and optimizing blood flow paths. Microfluidic oxygenators show promise as next-generation technology, but further research is needed to determine their clinical feasibility. The development of an anticoagulation-free artificial placenta requires a multidisciplinary approach and a combination of strategies to enhance hemocompatibility. [Extracted from the article]

Over decades of development, the modern drug delivery system continues to grapple with numerous challenges, including drug loading inefficiencies, issues of immunogenicity, and cytotoxicity. These limitations restrict its application across various systems. Microalgae, as a natural resource, are not only abundant in bioactive compounds but also possess multiple biological properties, including active surface, photosynthesis capabilities, and excellent biocompatibility. These attributes make microalgae highly promising as carriers for targeted drug delivery, offering significant potential for the diagnosis and treatment of various diseases. Therefore, leveraging the exceptional properties of microalgae for drug delivery and optimizing their qualities is of paramount importance. This article focuses on elucidating the biological characteristics of microalgae and their applications in drug delivery, with a particular emphasis on emerging strategies for efficient drug loading and precise targeted delivery. Microalgae, as a natural biomaterial, hold immense potential for both commercial and clinical applications.

Copyright of Turkish Journal of Clinical & Cardiovascular Perfusion / Türk Klinik ve Kardiyovasküler Perfüzyon Dergisi is the property of Galenos Yayinevi Tic. LTD. STI and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Turkish Journal of Clinical & Cardiovascular Perfusion / Türk Klinik ve Kardiyovasküler Perfüzyon Dergisi is the property of Galenos Yayinevi Tic. LTD. STI and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background: Despite systemic anticoagulation and antithrombotic surface coating, oxygenator dysfunction remains one of most common technical complications of Extracorporeal membrane oxygenation (ECMO). Several parameters have been associated with an oxygenator exchange, but no guidelines for when to perform an exchange are published. An exchange, especially an emergency exchange, has a risk of complications. Therefore, a delicate balance between oxygenator dysfunction and the exchange of the oxygenator exists. This study aimed to identify risk factors and predictors for elective and emergency oxygenator exchanges. Methods: This observational cohort study included all adult patients supported with veno-venous extracorporeal membrane oxygenation (V-V ECMO). We compared patients' characteristics and laboratory values of patients with and without an oxygenator exchange and between an elective and emergency exchange, defined as an exchange outside office hours. Risk factors for an oxygenator exchange were identified with cox regression analyses, and risk factors for an emergency exchange were identified with logistic regression analyses. Results: We included forty-five patients in the analyses. There were twenty-nine oxygenator exchanges in nineteen patients (42%). More than a third of the exchanges were emergency exchanges. Higher partial pressure of carbon dioxide (PaCO2), transmembrane pressure difference (ΔP), and hemoglobin (Hb) were associated with an oxygenator exchange. Lower lactate dehydrogenase (LDH) was the only risk factor for an emergency exchange. Conclusion: Oxygenator exchange is frequent during V-V ECMO support. PaCO2, ΔP and Hb were associated with an oxygenator exchange and lower LDH with the risk of an emergency exchange. [ABSTRACT FROM AUTHOR]

The aim of the study. To study the effect of high nitric oxide concentrations on hollow polypropylene fibers of oxygenators.Materials and methods. The study was conducted in two stages. At the first stage, we evaluated the stability of oxygenator membrane made of hollow polypropylene fibers after six hours of exposure to air-oxygen mixture containing NO at 500 parts per million, or 500 pro pro mille (ppm) concentration, using mass spectrometry and infrared spectroscopy. At the second stage, an experiment with cardiopulmonary bypass (CPB) was conducted on 10 pigs. In the study group (n=5) animals sweep gas was supplied to the oxygenator as an air-oxygen mixture with NO at 100 ppm. In the control group animals (n=5) an air-oxygen mixture was used without NO. The CPB lasted for 4 hours, followed by observation for 12 hours. NO, NO2 (at the inlet and outlet of the oxygenator), and the dynamics of methemoglobin were evaluated. After weaning of animals from CPB, the oxygenators were tested for leakproofness, and scanning electron microscopy (SEM) was performed.Results. The oxygenator made of polypropylene hollow fibers retained its gas transfer parameters after six hours of exposure to air-oxygen mixture containing NO at 500 ppm. Based on IR-Fourier spectroscopy findings, NO did not affect structural integrity of polypropylene membranes. NO added to gas mixture at 100 ppm did not increase NO2 to toxic level of 2 ppm in 91% of control tests during 4 hours CPB in pigs; mean value was 1.58 ± 0.28 ppm. Methemoglobin concentration did not exceed the upper limit of permissible level (3%), and there were no statistically significant differences with the control group. All tested oxygenators have passed the leakproofness test. According to SEM findings, larger amounts of fibrin deposits were found in the control group oxygenators vs study group.Conclusion. There were no negative effects of NO at 500 ppm concentration on the oxygenator membrane made of hollow polypropylene fibers. NO at 100 ppm in a gas-mixture supplied to oxygenators did not lead to an exceedance of safe NO2 and methemoglobin concentrations in an animal model. Reduced fibrin deposits on hollow fibers of polypropylene oxygenator membranes were observed when with NO at a level of 100 ppm was added to a gas mixture.

OBJECTIVES This study aimed to determine the oxygenator impact on alterations of remdesivir (RDV) in a contemporary neonatal/pediatric (1/4-inch) and adolescent/adult (3/8-inch) extracorporeal membrane oxygenation (ECMO) circuit including the Quadrox-i oxygenator. METHODS One-quarter--inch and a 3/8-inch, simulated closed-loop ECMO circuits were prepared with a Quadrox-i pediatric and Quadrox-i adult oxygenator and blood primed. Additionally, 1/4-inch and 3/8-inch circuits were also prepared without an oxygenator in series. A 1-time dose of RDV was administered into the circuits and serial preoxygenator and postoxygenator concentrations were obtained at 0 to 5 minutes, and 1-, 2-, 3-, 4-, 5-, 6-, 8-, 12-, and 24-hour time points. The RDV was also maintained in a glass vial and samples were taken from the vial at the same time periods for control purposes to assess for spontaneous drug degradation. RESULTS For the 1/4-inch circuits with an oxygenator, there was a 35% to 60% RDV loss during the study period. For the 1/4-inch circuits without an oxygenator, there was a 5% to 20% RDV loss during the study period. For the 3/8-inch circuit with and without an oxygenator, there was a 60% to 70% RDV loss during the study period. CONCLUSIONS There was RDV loss within the circuit during the study period and the RDV loss was more pronounced with the larger 3/8-inch circuit when compared with the 1/4-inch circuit. The impact of the oxygenator on RDV loss appears to be variable and possibly dependent on the size of the circuit and oxygenator. These preliminary data suggest RDV dosing may need to be adjusted for concern of drug loss via the ECMO circuit. Additional single- and multiple-dose studies are needed to validate these findings. [ABSTRACT FROM AUTHOR]

Copyright of Chinese Medical Equipment Journal is the property of Chinese Medical Equipment Journal Editorial Office and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Small animal models are widely used in basic research. However, experimental hydrodynamic test benches, which include extracorporeal circuits, often have limitations associated with the size and filling volume of equipment. Thus, we aimed at developing and validating a miniature oxygenator as well as a low-volume hydrodynamic system for ex vivo perfusion of small animal lungs. A series of low-volume membrane oxygenators (n = 10) with 90–100 aligned microporous polypropylene hollow fibers, placed inside a sheath that is sealed at both ends to isolate the perfusing solution, was designed and manufactured. This design makes gas to flow through the hollow fibers and perfusate to circulate around the fibers. A low-volume hydrodynamic test bench was designed and assembled for isolated ex vivo lung perfusion and for evaluation of the performance characteristics of the oxygenators: gas and perfusate flow, perfusion pressure and temperature at 5–70 ml/min flow range.

The article proposes a new, interspecies interpretation of Joanna Rajkowska’s Oxygenator. Read as what Anna Tsing calls latent commons and problematized through Chantal Mouffe’s concept of agonistic spaces, the canonical piece of public art is shown to have been an experimental site of more-than-human resurgence.

Simple Summary: Animal experiments are essential for the development and optimization of innovative biomedical soft- or hardware. These technologies, not least in the field of intensive care, contribute to an enhanced quality of care and chances of survival. One prominent example that gained public attention due to the COVID-19 pandemic is extracorporeal membrane oxygenation, in short ECMO, as it supports the heart and lungs during severe disease. Even though ECMO is already in use, the components, e.g., the oxygenator that acts as an artificial lung, need further improvement. The basic functions of new devices, e.g., the oxygenation performance, do not necessarily require living animals for the evaluation; therefore, the present study aimed to develop a post-mortem rat cadaver perfusion model exclusively using surplus animals, e.g., from in-house breeding, to reduce the number of animals used for these models, according to the animal welfare principle (the 3Rs: Replace, Reduce, Refine). It was shown that the established rat cadaver model allowed organ perfusion for up to eight hours, making it a promising model for testing new biomedical technology and, thus, a welfare-friendly alternative for existing living rat perfusion models. The development of biomedical soft- or hardware frequently includes testing in animals. However, large efforts have been made to reduce the number of animal experiments, according to the 3Rs principle. Simultaneously, a significant number of surplus animals are euthanized without scientific necessity. The primary aim of this study was to establish a post-mortem rat perfusion model using extracorporeal membrane oxygenation (ECMO) in surplus rat cadavers and generate first post vivo results concerning the oxygenation performance of a recently developed ECMO membrane oxygenator. Four rats were euthanized and connected post-mortem to a venous–arterial ECMO circulation for up to eight hours. Angiographic perfusion proofs, blood gas analyses and blood oxygenation calculations were performed. The mean preparation time for the ECMO system was 791 ± 29 s and sufficient organ perfusion could be maintained for 463 ± 26 min, proofed via angiographic imaging and a mean femoral arterial pressure of 43 ± 17 mmHg. A stable partial oxygen pressure, a 73% rise in arterial oxygen concentration and an exponentially increasing oxygen extraction ratio up to 4.75 times were shown. Considering the 3Rs, the established post-mortal ECMO perfusion rat model using surplus animals represents a promising alternative to models using live animals. Given the preserved organ perfusion, its use could be conceivable for various biomedical device testing. [ABSTRACT FROM AUTHOR]

Introduction: Extracorporeal Membrane Oxygenation (ECMO) is used as a bridge to recovery of cardiac function following completion of congenital cardiac surgeries where there is failure to wean from cardiopulmonary bypass (CPB) or severe low cardiac output states in the post operative periods. Although ECMO is a well-established form of mechanical circulatory support, the associated cost can be a huge financial burden on families. We are an ECMO center and use the same in post operative congenital cardiac surgeries for mechanical cardiovascular support if needed. However, a significant proportion of the children, whom we operate, are funded by government aides. The resources are limited in such circumstances. If needed, we use the same CPB circuit and cannulae used in the Operating Room (OR) and support them at a significantly lower cost compared to ECMO. Methods: We report our experience of using conventional CPB machine as a short-term bridge to recovery of cardiac function in Intensive Care Unit where there was limitation of funds. Essentially same CPB circuit with roller pump is retained, by omitting cardiotomy suckers. We use D901 Lilliput 1 Oxygenator (Sorin, Italy) for children <5 kg and D902 Lilliput 2 (Sorin, Italy) Oxygenator for children >5 Kg. Results: We supported nine patients on CPB between March 2019 and December 2021. During this time, 1392 congenital cardiac surgeries were performed. We could wean off three patients (33.3%) and discharge two patients (22.2%). Our support time ranged from 21 h to 60 h with a median of 48 h. Beyond 48 h of support, we experienced several CPB induced complications in our cohort. Conclusion: In resource-limited settings, conventional CPB machines can be used for short-term cardiac support. Although results may not be comparable to using ECMO, some patients can be definitely salvaged, who would otherwise die in the absence of institution of mechanical circulatory support. [ABSTRACT FROM AUTHOR]

Membrane artificial lungs (oxygenators) are used in cardiopulmonary surgery as well as, in some cases, in severe lung disease to support the natural lung by means of ECMO (extracorporeal membrane oxygenation). The oxygen and carbon dioxide transfer rates of any oxygenator are usually assessed by considering several blood gas parameters, such as oxygen saturation, hemoglobin concentration, partial pressure of oxygen and carbon dioxide, bicarbonate concentration, and p H . Here, we report a set of semi-empirical equations that calculate such parameters directly from their partial pressures and assess the acid–base balance during ECMO. The implementation of this equation set permits the evaluation of any oxygenator, existing or prototypes in development, as well as the development of clinical decision-making tools for predicting the blood gas state and acid–base balance during surgical interventions and ECMO. The predicted results are then compared with experimental data obtained from in vitro gas exchange investigations with a commercial oxygenator using fresh porcine blood. The high correlation, R 2 > 0.95 , between the predicted and the experimental data suggests a possibility of using such empirical equations in the simulation of gas transfer in a cardiopulmonary system with an oxygenator for any venous inlet blood gas data and also for estimating the acid–base balance during such therapy. [ABSTRACT FROM AUTHOR]

Background: Pulsatile extracorporeal circulation (ECC) may improve perfusion of critical organs during cardiac surgery. This study analyzed the influence of the components of a minimal invasive ECC (MiECC) on the transfer of pulsatile energy into the pseudo‐patient of a mock circulation. Methods: An aortic model with human‐like geometry and compliance was perfused by a diagonal pump. Surplus hemodynamic energy (SHE) was determined from flow and pressure data. Five adult‐size oxygenator models and three sizes of cannulas were compared. Pulsatile pump settings were optimized, and parallel dual‐pump configurations were evaluated. Results: Oxygenator models showed up to twofold differences in pressure gradients and influenced SHE at flow rates up to 2.0 L min−1. Adjustments of frequency, systole duration, and rotational speed gain significantly improved SHE compared with empirical settings, with SHE above 21% of mean arterial pressure at flow rates of 1.0 L min−1 to 1.5 L min−1 and SHE above 5% at 3.5 L min−1. Small diameter cannula (15 Fr) limited SHE compared with larger cannula (21 Fr and 23 Fr). Two diagonal pumps did not provide higher SHE than a single pump, but permitted additional control over pulse pressure and SHE by varying the total fraction of pulsatile flow and the fraction of flow bypassing the oxygenator. Conclusions: Proper selection of components and optimizations of pump settings significantly improved pulse pressure and SHE of pulsatile MiECC. Surplus hemodynamic energy depended on flow rate with a maximum at 1.0 L min−1–1.5 L min−1. Pulsatile MiECC may specifically assist organ perfusion during phases of low flow. [ABSTRACT FROM AUTHOR]

Introduction: The novel Capiox NX19 adult oxygenator is, compared to its predecessors, improved with enhanced air removal technology, a polymer heat exchanger and smaller, innovative hollow fibers resulting in a surface area reduction and a lower priming volume. The aim of this study was to evaluate the NX19 oxygenator performance in a clinical setting. Methods: A prospective multicenter study was performed involving three large European university hospitals. The Capiox NX19 (n = 150) performance was assessed during adult cardiopulmonary bypass and involved gaseous microemboli handling and gas transfer efficiency. The heat exchanger performance was evaluated separately in vitro. Results: The heat exchanger performance factors were 0.80 ± 0.03 and 0.58 ± 0.04 at pump flow rates of 3 L/min and 6 L/min, respectively. After priming, residual post-oxygenator gaseous microemboli count and volume were decreased by 91% and 93.7%, respectively. The gas compartment pressure was 6.0 ± 2.5 mmHg, while the O2 transfer was 69 ± 30 mL/min/m2 and the CO2 transfer 73 ± 34 mL/min/m2. The O2 gradient was 44 ± 19 mmHg/LPM and the O2 diffusing capacity 0.38 ± 0.14 mL/min/mmHg. The shunt fraction was 0.19 ± 0.13, whereas oxygenator resistance and shear stress were 10.5 ± 3.7 mmHg/LPM and 5.1 ± 3.1 dyn/cm2, respectively. Conclusion: This multicenter study displayed good clinical safety and performance of the NX19 oxygenator. [ABSTRACT FROM AUTHOR]

Background: Extracorporeal membrane oxygenation (ECMO) became an accepted therapy for the treatment of severe acute respiratory distress syndrome and chronic obstructive pulmonary disease. However, ECMO systems are still prone to thrombus formation and decrease of gas exchange over time. Therefore, it is necessary to conduct qualified studies to identify parameters for optimization of ECMO systems, and especially the oxygenator. However, commercially marketed oxygenators are not always appropriate and available for certain research use cases. Therefore, we aimed to design an oxygenator, which is suitable for various test conditions such as blood tests, numerical simulation, and membrane studies, and can be modified in membrane area size and manufactured in laboratory. Methods: Main design criteria are a homogeneous blood flow without stagnation zones, low pressure drop, manufacturability in the lab, size variability with one set of housing parts and cost‐efficiency. Our newly designed oxygenator was tested comparatively regarding blood cell damage, gas transfer performance and pressure drop to prove the validity of the design in accordance with a commercial device. Results: No statistically significant difference between the tested oxygenators was detected and our new oxygenator demonstrated sufficient hemocompatibility. Furthermore, our variable oxygenator has proven that it can be easily manufactured in the laboratory, allows to use various membrane fiber configurations and can be reopened easily and non‐destructively for analysis after use, and the original geometry is available for numerical simulations. Conclusion: Therefore, we consider this newly developed device as a valuable tool for basic experimental and numerical research on the optimization of oxygenators. [ABSTRACT FROM AUTHOR]

When employing minimal invasive extracorporeal circulation (MiECC), the removal of bubbles in the circuit is important to prevent air embolism. We investigated the bubble removal performance of the FHP oxygenator with a pre-filter and compared it with that of four oxygenators, including the Fusion oxygenator, Quadrox oxygenator, Inspire oxygenator, and FX oxygenator. A closed test circuit filled with an aqueous glycerin solution was used. Air injection (10 mL) was performed prior to the oxygenator, and the number and volume of the bubbles were measured at the inlet and outlet of each oxygenator. At the inlet of the five oxygenators, there were no significant differences in the total number of bubbles detected. At the outlet, bubbles were classified into two groups according to the bubble size: ≥100 μm and <100 μm. Tests were performed at pump flow rates of 4 and 5 L/min. For bubbles ≥100 μm, which are considered clinically detrimental, the FHP was the lowest number and volume of bubbles at both pump flow rates compared to the other oxygenators. Regarding the bubbles <100 μm, the number of bubbles was higher in the FHP than those in others; however, the volume of bubbles was significantly lower at 4 L/min and tended to be lower at 5 L/min. The use of the FHP with the pre-filter removed more bubbles ≥100 μm in the circuit than that by the other oxygenators. Graphical Abstract [ABSTRACT FROM AUTHOR]

The overall survival rate of extracorporeal life support (ECLS) remains at 60%. Research and development has been slow, in part due to the lack of sophisticated experimental models. This publication introduces a dedicated rodent oxygenator ("RatOx") and presents preliminary in vitro classification tests. The RatOx has an adaptable fiber module size for various rodent models. Gas transfer performances over the fiber module for different blood flows and fiber module sizes were tested according to DIN EN ISO 7199. At the maximum possible amount of effective fiber surface area and a blood flow of 100 mL/min, the oxygenator performance was tested to a maximum of 6.27 mL O2/min and 8.2 mL CO2/min, respectively. The priming volume for the largest fiber module is 5.4 mL, while the smallest possible configuration with a single fiber mat layer has a priming volume of 1.1 mL. The novel RatOx ECLS system has been evaluated in vitro and has demonstrated a high degree of compliance with all pre-defined functional criteria for rodent-sized animal models. We intend for the RatOx to become a standard testing platform for scientific studies on ECLS therapy and technology. [ABSTRACT FROM AUTHOR]

Fuel quality control had become increasingly important due to the direct relationship between fuel quality and vehicle emissions. Variability of gasoline fuel from one refilling station to another is analyze using Fourier Transform Infrared spectroscopy (FTIR) and Principal Component Analysis (PCA). The result indicates that HC chain length, oxygenate, toluene and aromatic content are the major variables that cause sample variation and grouping. Determination of kerosene and Methyl tert-Butyl Ether (MTBE) concentration in gasoline fuel is done by using partial least squares (PLS) regression multivariate technique as applied to FTIR-ATR spectral data of the test samples. PLS calibration models were developed for the prediction of kerosene and MTBE and validated with independent set of known samples. Accordingly, among 179 tested samples, 103 samples contain kerosene (% v/v) less than 10%, 61 samples contain 11–20%, 11 samples contain 21–30% and 4 samples exceed 30% resulting that majority of gasoline fuel in the study area are adulterated. It is observed that 17 samples are MTBE blended with varying concentrations in the range of 1–7.34% v/v. This study provides an inexpensive and effective method to investigate gasoline quality, detection of adulterants and oxygenator in areas where adulteration of fuel is quite popular. [ABSTRACT FROM AUTHOR]

Extracorporeal life support is an advanced therapy that circulates blood through an extracorporeal oxygenator, performing gas exchange outside the body. However, its use is limited by severe complications, including bleeding, clotting, and hemolysis. Semiconductor silicon-based membranes have emerged as an alternative to traditional hollow-fiber semipermeable membranes. These membranes offer excellent gas exchange efficiency and the potential to increase hemocompatibility by improving flow dynamics. In this work, we evaluate two next-generation silicon membrane designs, which are intended to be mechanically robust and efficient in gas exchange, while simultaneously reducing fabrication complexity. The "window" design features 10 µm pores on one side and large windows on the back side. The "cavern" design also uses 10 µm pores but contains a network of interconnected buried caverns to distribute the sweep gas from smaller inlet holes. Both designs were shown to be technically viable and able to be reproducibly fabricated. In addition, they both were mechanically robust and withstood 30 psi of transmembrane pressure without breakage or bubbling. At low sweep gas pressures, gas transfer efficiency was similar, with the partial pressure of oxygen in water increasing by 10.7 ± 2.3 mmHg (mean ± standard deviation) and 13.6 ± 1.9 mmHg for the window and cavern membranes, respectively. Gas transfer efficiency was also similar at higher pressures. At 10 psi, oxygen tension increased by 16.8 ± 5.7 mmHg (window) and 18.9 ± 1.3 mmHg (cavern). We conclude that silicon membranes featuring a 10 µm pore size can simplify the fabrication process and improve mechanical robustness while maintaining excellent efficiency. [ABSTRACT FROM AUTHOR]

The development of biomedical soft- or hardware frequently includes testing in animals. However, large efforts have been made to reduce the number of animal experiments, according to the 3Rs principle. Simultaneously, a significant number of surplus animals are euthanized without scientific necessity. The primary aim of this study was to establish a post-mortem rat perfusion model using extracorporeal membrane oxygenation (ECMO) in surplus rat cadavers and generate first post vivo results concerning the oxygenation performance of a recently developed ECMO membrane oxygenator. Four rats were euthanized and connected post-mortem to a venous–arterial ECMO circulation for up to eight hours. Angiographic perfusion proofs, blood gas analyses and blood oxygenation calculations were performed. The mean preparation time for the ECMO system was 791 ± 29 s and sufficient organ perfusion could be maintained for 463 ± 26 min, proofed via angiographic imaging and a mean femoral arterial pressure of 43 ± 17 mmHg. A stable partial oxygen pressure, a 73% rise in arterial oxygen concentration and an exponentially increasing oxygen extraction ratio up to 4.75 times were shown. Considering the 3Rs, the established post-mortal ECMO perfusion rat model using surplus animals represents a promising alternative to models using live animals. Given the preserved organ perfusion, its use could be conceivable for various biomedical device testing.

Background: Antithrombogenicity of extracorporeal membrane oxygenation (ECMO) devices, particularly oxygenators, is a current problem, with numerous studies and developments underway. However, there has been limited progress in developing methods to accurately compare the antithrombogenicity of oxygenators. Animal experiments are commonly conducted to evaluate the antithrombogenicity of devices; however, it is challenging to maintain a steady experimental environment. We propose an innovative experimental animal model to evaluate different devices in a constant experimental environment in real‐time. Methods: This model uses two venous–arterial ECMO circuits attached to one animal (one by jugular vein and carotid artery, one by femoral vein and artery) and real‐time assessment of thrombus formation in the oxygenator by indocyanine green (ICG) fluorescence imaging. Comparison studies were conducted using three pigs: one to compare different oxygenators (MERA vs. CAPIOX) (Case 1), and two to compare antithrombotic properties of the oxygenator (QUADROX) when used under different hydrodynamic conditions (continuous flow vs. pulsatile flow) (Cases 2 and 3). Results: Thrombi, visualized using ICG imaging, appeared as black dots on a white background in each oxygenator. In Case 1, differences in the site of thrombus formation and rate of thrombus growth were observed in real‐time in two oxygenators. In Case 2 and 3, the thrombus region was smaller in pulsatile than in continuous conditions. Conclusions: We devised an innovative experimental animal model for comparison of antithrombogenicity in ECMO circuits. This model enabled simultaneous evaluation of two different ECMO circuits under the same biological conditions and reduced the number of sacrificed experimental animals. [ABSTRACT FROM AUTHOR]

Towards the establishment of a long-term lung-assist device to be used both as a bridge and as an alternative to lung transplantation according to final destination therapy, we develop the biohybrid lung (BHL) on the technical basis of contemporary extracorporeal membrane oxygenation (ECMO). Here, to overcome the significant drawbacks of ECMO, in particular the missing hemocompatibility of the artificial surfaces, all blood-contacting areas need to be endothelialized sufficiently. In continuation of our recent accomplishments, demonstrating the feasibility of establishing a physiological acting endothelial cell (EC) monolayer on the hollow fiber membranes (HFMs) of the ECMO in vitro, the next step towards BHL translation is the endothelialization of the complete oxygenator, consisting of HFMs and the surrounding housing. Therefore, we assessed EC seeding inside our model oxygenator (MOx), which simulated the conditions in the assembled HFM oxygenators in order to identify the most important factors influencing efficient endothelialization, such as cell seeding density, cell distribution, incubation time and culture medium consumption. Overall, upon adjusting the concentration of infused ECs to 15.2 × 104/cm2 and ensuring optimal dispersion of cells in the MOx, viable and confluent EC monolayers formed on all relevant surfaces within 24 h, even though they comprised different polymers, i.e., the fibronectin-coated HFMs and the polysulfone MOx housing. Periodic medium change ensured monolayer survival and negligible apoptosis rates comparable to the reference within the assembled system. By means of these results, revealing essential implications for BHL development, their clinical translation is coming one step closer to reality. [ABSTRACT FROM AUTHOR]

There continues to be an unmet therapeutic need for an alternative treatment strategy for respiratory distress and lung disease. We are developing a portable cardiopulmonary support system that integrates an implantable oxygenator with a hybrid, dual‐support, continuous‐flow total artificial heart (TAH). The TAH has a centrifugal flow pump that is rotating about an axial flow pump. By attaching the hollow fiber bundle of the oxygenator to the base of the TAH, we establish a new cardiopulmonary support technology that permits a patient to be ambulatory during usage. In this study, we investigated the design and improvement of the blood flow pathway from the inflow‐to‐outflow of four oxygenators using a mathematical model and computational fluid dynamics (CFD). Pressure loss and gas transport through diffusion were examined to assess oxygenator design. The oxygenator designs led to a resistance‐driven pressure loss range of less than 35 mmHg for flow rates of 1–7 L/min. All of the designs met requirements. The configuration having an outside‐to‐inside blood flow direction was found to have higher oxygen transport. Based on this advantageous flow direction, two designs (Model 1 and 3) were then integrated with the axial‐flow impeller of the TAH for simulation. Flow rates of 1–7 L/min and speeds of 10,000–16,000 RPM were analyzed. Blood damage studies were performed, and Model 1 demonstrated the lowest potential for hemolysis. Future work will focus on developing and testing a physical prototype for integration into the new cardiopulmonary assist system. [ABSTRACT FROM AUTHOR]

Resumen: Una placenta artificial es una plataforma de soporte vital para bebés prematuros o que tuvieron menos de 37 semanas de gestación completa. Aunque existe la posibilidad de utilizar esta plataforma para la reparación intraoperatoria de anomalías congénitas (p. ej., hernia diafragmática congénita) en bebés prematuros tardíos, o para el estudio del desarrollo fetal, el objetivo principal de esta tecnología es actualmente el tratamiento de bebés extremadamente prematuros, o aquellos nacidos durante el período peri-viable entre las 21-24 semanas de gestación completa.Los bebés que nacen en este período peri-viable, generalmente tienen malos resultados debido a la necesidad de ventilar mecánicamente sus pulmones extremadamente inmaduros, a menudo a altas presiones máximas. Las plataformas de soporte vital basadas en placenta artificial están diseñadas para evitar la necesidad de ventilar como un medio para facilitar el intercambio de gases y así evitar lesiones en el pulmón prematuro inmaduro. En cambio, el intercambio de gases altamente eficiente y fácilmente regulado se realiza mediante dispositivos de intercambio de gases conectados a la vasculatura fetal. Dependiendo de la forma del sistema utilizado, se han probado diseños de circuitos venoso-venosos y arterio-venosos, con los prototipos arterio-venosos más recientes que utilizan el corazón fetal, en lugar de una bomba externa, para generar la presión del circuito.A pesar de tener la apariencia de un concepto futurista, el trabajo de desarrollar una placenta artificial se ha llevado a cabo de forma intermitente desde al menos finales de los años 50. El hecho de que la tecnología aún no haya entrado en servicio clínico, a pesar de que han pasado más de 60 años, refleja los desafíos técnicos que rodean el desarrollo y uso de la placenta artificial. Esta demora en la introducción también refleja el panorama cambiante de la atención neonatal y, en particular, los avances en la ventilación mecánica y los modos de soporte respiratorio no invasivo, como la presión positiva continua en las vías respiratorias, la introducción de esteroides prenatales y la disponibilidad de terapia con surfactante exógeno.Como tal, es razonable argumentar que el grupo demográfico objetivo para la tecnología de placenta artificial ha cambiado significativamente desde que comenzó su desarrollo. Los bebés que antes se consideraban peri-viables y probables candidatos para la terapia con placenta artificial (es decir, los que nacieron antes de las 28 semanas de gestación) ahora tienen tasas mucho mejores de supervivencia libre de enfermedad con la tecnología disponible en la actualidad. El grupo demográfico con los peores resultados, y los posibles candidatos para la terapia de placenta artificial contemporánea, son aquellos nacidos de embarazos significativamente comprometidos (por ejemplo, infección intrauterina, sepsis, preeclampsia severa, insuficiencia placentaria severa) a las 21-24 semanas de gestación y con un peso de aprox. 300 gramos.Este artículo proporcionará una revisión del historial de desarrollo de la placenta artificial, un resumen de la situación actual y concluirá discutiendo los desafíos restantes que deberán abordarse antes de que esta tecnología pueda introducirse en la práctica clínica. Summary: An artificial placenta is a life support platform for babies born preterm, or prior to 37 weeks’ completed gestation. Although there is potential to use this platform for the intraoperative repair of congenital abnormalities (e.g. congenital diaphragmatic hernia) in late preterm babies, or for the study of fetal development, the primary target for this technology is currently treatment of extremely preterm infants, or those delivered during the peri-viable period between 21-24 weeks’ completed gestation.Babies born in this peri-viable period generally have poor outcomes due to the need to mechanically ventilate their extremely immature lungs–often at high peak pressures. Artificial placenta-based life support platforms are designed to obviate the need to ventilate as a means of facilitating gas exchange, and thus avoid injury to the immature preterm lung. Instead, highly efficient, and easily regulated gas exchange is performed by gas-exchange devices connected to the fetal vasculature. Depending on the form of the system used, venous-venous and arterio-venous circuit designs have been trialled, with the more recent arterio-venous prototypes using the fetal heart, rather than an external pump, to generate circuit pressure.Despite having the appearance of a futuristic concept, work to develop an artificial placenta has been undertaken intermittently since at least the late 1950s. That the technology is yet to enter clinical service, despite 60-plus years of work, reflects the technical challenges surrounding the development and use of the artificial placenta. This delay in introduction also reflects the changing neonatal care landscape, and notably advances in mechanical ventilation and non-invasive respiratory support modes such as continuous positive airway pressure, the introduction of antenatal steroids, and the availability of exogenous surfactant therapy.As such, it is reasonable to argue that the target demographic for artificial placenta technology has changed significantly since development first began. Babies once considered peri-viable and a probable candidate for artificial placenta therapy (i.e. those born below 28 weeks’ gestation) now have much improved rates of disease-free survival using currently available technology. The demographic with the poorest outcomes, and the likely candidates for contemporary artificial placenta therapy, are those born from significantly compromised pregnancies (e.g. intrauterine infection, sepsis, severe pre-eclampsia, severe placental insufficiency) at 21-24 weeks’ gestation and weighing as little as 300 grams.This paper will provide a review of the development history of the artificial placenta, a summary of the current state-of-play, and conclude by discussing the remaining challenges that will need to be addressed before this technology might be introduced to clinical practice.

Membrane artificial lungs (oxygenators) are used in cardiopulmonary surgery as well as, in some cases, in severe lung disease to support the natural lung by means of ECMO (extracorporeal membrane oxygenation). The oxygen and carbon dioxide transfer rates of any oxygenator are usually assessed by considering several blood gas parameters, such as oxygen saturation, hemoglobin concentration, partial pressure of oxygen and carbon dioxide, bicarbonate concentration, and pH. Here, we report a set of semi-empirical equations that calculate such parameters directly from their partial pressures and assess the acid–base balance during ECMO. The implementation of this equation set permits the evaluation of any oxygenator, existing or prototypes in development, as well as the development of clinical decision-making tools for predicting the blood gas state and acid–base balance during surgical interventions and ECMO. The predicted results are then compared with experimental data obtained from in vitro gas exchange investigations with a commercial oxygenator using fresh porcine blood. The high correlation, R2>0.95, between the predicted and the experimental data suggests a possibility of using such empirical equations in the simulation of gas transfer in a cardiopulmonary system with an oxygenator for any venous inlet blood gas data and also for estimating the acid–base balance during such therapy.

Extracorporeal membrane oxygenation (ECMO) is an important rescue therapy method for the treatment of severe hypoxic lung injury. In some cases, oxygen saturation and oxygen partial pressure in the arterial blood are low despite ECMO therapy. There are case reports in which patients with such instances of refractory hypoxemia received a second membrane lung, either in series or in parallel, to overcome the hypoxemia. It remains unclear whether the parallel or serial connection is more effective. Therefore, we used an improved version of our full-flow ECMO mock circuit to test this. The measurements were performed under conditions in which the membrane lungs were unable to completely oxygenate the blood. As a result, only the photometric pre- and post-oxygenator saturations, blood flow and hemoglobin concentration were required for the calculation of oxygen transfer rates. The results showed that for a pre-oxygenator saturation of 45% and a total blood flow of 10 L/min, the serial connection of two identical 5 L rated oxygenators is 17% more effective in terms of oxygen transfer than the parallel connection. Although the idea of using a second membrane lung if refractory hypoxia occurs is intriguing from a physiological point of view, due to the invasiveness of the solution, further investigations are needed before this should be used in a wider clinical setting.

The use of extracorporeal oxygenation and CO2 removal has gained clinical validity and popularity in recent years. These systems are composed of a pump to drive blood flow through the circuit and a hollow fiber membrane bundle through which gas exchange is achieved. Mathematical modeling of device design is utilized by researchers to improve device hemocompatibility and efficiency. A previously published mathematical model to predict CO2 removal in hollow fiber membrane bundles was modified to include an empirical representation of the Haldane effect. The predictive capabilities of both models were compared to experimental data gathered from a fiber bundle of 7.9 cm in length and 4.4 cm in diameter. The CO2 removal rate predictions of the model including the Haldane effect reduced the percent error between experimental data and mathematical predictions by up to 16%. Improving the predictive capabilities of computational fluid dynamics for the design of hollow fiber membrane bundles reduces the monetary and manpower expenses involved in designing and testing such devices. [ABSTRACT FROM AUTHOR]