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Dialoxygenation: A Preclinical Trial for Transforming the Artificial Kidney Into an oxygenator

ASAIO JOURNAL 2025年第1期71卷 92-98页

作者： Karacanoglu, Dilek Bedir, Esra Nakip, Ozlem Saritas Kesici, Selman Duran, Hatice Bayrakci, Benan Hacettepe Univ Ctr Life Support Practice & Res Dept Pediat Intens Care Med Ankara Turkiye TOBB Univ Econ & Technol Dept Mat Sci & Nanotechnol Engn Ankara Turkiye Bilkent Univ UNAM Natl Nanotechnol Res Ctr Ankara Turkiye Bilkent Univ Inst Mat Sci & Nanotechnol Ankara Turkiye Etlik City Hosp Dept Pediat Intens Care Unit Ankara Turkiye

Critically ill patients sometimes require tandem application of extracorporeal membrane oxygenation (ECMO) and continuous renal replacement therapy (CRRT) which is easier and cheaper. We aimed to transform the kidney membrane into a lung membrane by adding hydrogen peroxide (H2O2) to the dialysate as the oxygen source. A solution containing H2O2 and a dialysate fluid mixture was used as the final dialysate. Starting with 100% H2O2 solution and gradually reducing the volume of H2O2, respectively: 50%, 10%, 5%, 4%, 3%, 2%, and 1%. PRISMAFLEX system, Prismaflex M60 set and a bag of packed red blood cells (pRBCs) were the prototype. blood flow rate was about 40 ml/minute and the dialysis rate was about 200 ml/m2/minute/1.73 m2. blood sampling times were;at the beginning (T0), at 15th (T1), 30th (T2), 60th (T3) minutes. Amongst eight attempts H2O2 concentration that increased the partial oxygen pressure (pO2) level significantly in a reasonable period, without any bubbles, was 3%. Methemoglobinemia was not observed in any trial. After the test with 3%, H2O2 in the dialysate fluid decreased progressively without any H2O2 detection at post-membrane blood. Three percent H2O2 solution is sufficient and safe for oxygenation in CRRT systems. With this new oxy-dialysate solution, both pulmonary and renal replacement can be possible via a single membrane in a simpler manner.

关键词： dialo-oxygenation extracorporeal membrane oxygenation continuous veno-venous hemodiafiltration artificial lung artificial kidney hydrogen peroxide biomembrane oxygenator

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Correlation Analysis Between Echinocytosis Stages and Blood Viscosity During oxygenator Perfusion: An In Vitro Study

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ASAIO JOURNAL 2024年第11期70卷 938-945页

作者： Okahara, Shigeyuki Miyamoto, Satoshi Soh, Zu Yoshino, Masaru Takahashi, Hidenobu Itoh, Hideshi Tsuji, Toshio Junshin Gakuen Univ Grad Sch Hlth Sci 1-1-1 Chikushigaoka Minami ku Fukuoka 8158510 Japan Hiroshima Univ Hosp Dept Clin Engn Hiroshima Japan Hiroshima Univ Grad Sch Adv Sci & Engn 1-4-1 kagamiyama Higashihiroshima 7398527 Japan Hiroshima Int Univ Fac Hlth Sci Dept Med Sci & Technol Hiroshima Japan Nippon Bunri Univ Dept Hlth & Med Sci Oita Japan

The study aimed to investigate the effect of red blood cell (RBC) morphology on oxygenator perfusion, focusing on stages of echinocytosis and their correlation with blood viscosity. A test circuit with an oxygenator and human RBC mixtures was used to induce changes in RBC shape by increasing sodium salicylate concentrations (0, 10, 20, 30, 60, and 120 mmol/L), while hematocrit, blood temperature, and anticoagulation were maintained. Blood viscosity was measured using a continuous blood viscosity monitoring system based on pressure-flow characteristics. Under a scanning electron microscope, the percentages of discocytes, echinocytes I-III, spheroechinocytes, and spherocytes were determined from approximately 400 cells per RBC sample. Early echinocytes, mainly discocytes and echinocytes I and II in the range of 0-30 mmol/L were predominant, resulting in a gradual increase in blood viscosity from 1.78 +/- 0.12 to 1.94 +/- 0.12 mPa s. At 60 mmol/L spherocytes emerged, and at 120 mmol/L, spheroidal RBCs constituted 50% of the population, and blood viscosity sharply rose to 2.50 +/- 0.15 mPa s, indicating a 40% overall increase. In conclusion, the presence of spherocytes significantly increases blood viscosity, which may affect oxygenator perfusion.

关键词： blood viscosity cardiopulmonary bypass hematocrit oxygenator pressure monitoring

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Development and evaluation of a variable, miniaturized oxygenator for various test methods

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ARTIFICIAL ORGANS 2023年第4期47卷 695-704页

作者： Arens, Jutta Schraven, Lotte Kaesler, Andreas Flege, Christian Schmitz-Rode, Thomas Rossaint, Rolf Steinseifer, Ulrich Kopp, Ruedger Univ Twente Fac Engn Technol Dept Biomech Engn Engn Organ Support Technol Grp Enschede Netherlands Rhein Westfal TH Aachen Helmholtz Inst Inst Appl Med Engn Med FacDept Cardiovasc Engn Aachen Germany Rhein Westfal TH Aachen Med Fac Dept Intens Care Med Aachen Germany Rhein Westfal TH Aachen Helmholtz Inst Inst Appl Med Engn Med Fac Aachen Germany Rhein Westfal TH Aachen Med Fac Dept Anesthesiol Aachen Germany

BackgroundExtracorporeal 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. MethodsMain 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. ResultsNo 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. ConclusionTherefore, we consider this newly developed device as a valuable tool for basic experimental and numerical research on the optimization of oxygenators.

关键词： adaptable extracorporeal lung assist gas exchange hemocompatibility hemolysis oxygenator variable

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Risk factors for elective and emergency oxygenator exchanges during veno-venous extracorporeal membrane oxygenation

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PERFUSION-UK 2024年第5期39卷 911-920页

作者： van Minnen, Olivier Oude Lansink-Hartgring, Annemieke Hoffmann, Roland F. van den Bergh, Walter M. Univ Groningen Dept Crit Care Univ Med Ctr Groningen Groningen Netherlands Univ Groningen Sect Extracorporeal Circulat Univ Med Ctr Groninge Dept Cardiothorac Surg Groningen Netherlands Univ Med Ctr Groningen Dept Crit Care Room R3 904POB 30001 NL-9700 RB Groningen Netherlands

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 (Delta P), 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, Delta P and Hb were associated with an oxygenator exchange and lower LDH with the risk of an emergency exchange.

关键词： extracorporeal membrane oxygenation exchanges oxygenator

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Clinical evaluation of the novel Capiox NX19 adult oxygenator-a multicenter study

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PERFUSION-UK 2023年第4期38卷 734-739页

作者： Hendrix, Rik H. J. Debeuckelaere, Gerdy Degezelle, Karlien Lenaerts, Lieven Verbelen, Tom Weerwind, Patrick W. Maastricht Univ Dept Cardiothorax Surg Med Ctr P Debeyelaan 25 POB 5800 NL-6229 HX Maastricht Netherlands Univ Hosp Antwerp Dept Extra Corporeal Circulat Edegem Belgium Univ Hosp Leuven Dept Perfus Technol Leuven Belgium Univ Hosp Leuven Dept Cardiac Surg Leuven Belgium

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 O-2 transfer was 69 +/- 30 mL/min/m(2) and the CO2 transfer 73 +/- 34 mL/min/m(2). The O-2 gradient was 44 +/- 19 mmHg/LPM and the O-2 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/cm(2), respectively. Conclusion This multicenter study displayed good clinical safety and performance of the NX19 oxygenator.

关键词： perfusion oxygenator Terumo Capiox NX19 clinical performance oxygenator evaluation cardiopulmonary bypass microemboli gas transfer oxygen transfer carbon dioxide transfer heat exchanger performance

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Multilayer Scaling of a Biomimetic Microfluidic oxygenator

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ASAIO JOURNAL 2022年第10期68卷 1312-1319页

作者： Vedula, Else M. Isenberg, Brett C. Santos, Jose Lai, WeiXuan Lewis, Diana J. Sutherland, David Roberts, Teryn R. Harea, George T. Wells, Christian Teece, Bryan Urban, Joseph Risoleo, Thomas Solt, Derek Leazer, Sahar Chung, Kevin Sukavaneshvar, Sivaprasad Batchinsky, Andriy, I Borenstein, Jeffrey T. Draper Cambridge MA 02139 USA Geneva Fdn Autonomous Reanimat & Evacuat AREVA Res Program San Antonio TX USA Thrombodyne Inc Salt Lake City UT USA Uniformed Serv Univ Hlth Sci Bethesda MD 20814 USA

Extracorporeal membrane oxygenation (ECMO) has been advancing rapidly due to a combination of rising rates of acute and chronic lung diseases as well as significant improvements in the safety and efficacy of this therapeutic modality. However, the complexity of the ECMO blood circuit, and challenges with regard to clotting and bleeding, remain as barriers to further expansion of the technology. Recent advances in microfluidic fabrication techniques, devices, and systems present an opportunity to develop new solutions stemming from the ability to precisely maintain critical dimensions such as gas transfer membrane thickness and blood channel geometries, and to control levels of fluid shear within narrow ranges throughout the cartridge. Here, we present a physiologically inspired multilayer microfluidic oxygenator device that mimics physiologic blood flow patterns not only within individual layers but throughout a stacked device. Multiple layers of this microchannel device are integrated with a three-dimensional physiologically inspired distribution manifold that ensures smooth flow throughout the entire stacked device, including the critical entry and exit regions. We then demonstrate blood flows up to 200 ml/min in a multilayer device, with oxygen transfer rates capable of saturating venous blood, the highest of any microfluidic oxygenator, and a maximum blood flow rate of 480 ml/min in an eight-layer device, higher than any yet reported in a microfluidic device. Hemocompatibility and large animal studies utilizing these prototype devices are planned.

关键词： microfluidics oxygenator transfer scaling multilayer

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Novel hybrid total artificial heart with integrated oxygenator

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JOURNAL OF CARDIAC SURGERY 2022年第12期37卷 5172-5186页

作者： Chopski, Steven G. G. Govender, Krianthan May, Alexandra Garven, Ellen Stevens, Randy M. M. Tchantchaleishvili, Vakhtang Throckmorton, Amy L. L. Drexel Univ Sch Biomed Engn BioCirc Res Lab Sci & Hlth Syst Philadelphia PA USA McGowan Inst Regenerat Med Swanson Sch Engn Dept Bioengn Pittsburgh PA USA Drexel Univ St Christophers Hosp Children Coll Med Philadelphia PA USA Thomas Jefferson Univ Div Cardiac Surg Philadelphia PA USA Drexel Univ Bossone Res Enterprise Ctr Sch Biomed Engn Sci & Hlth Syst 3141 Chestnut St Rm 718 Philadelphia PA 19104 USA

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.

关键词： ECMO heart pump oxygenator respiratory failure total artificial heart

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Extracorporeal Membrane oxygenator Failure in a Patient With Gestational Trophoblastic Neoplasm: Possible Mechanisms and Considerations in Critical Care

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JOURNAL OF CARDIOTHORACIC AND VASCULAR ANESTHESIA 2022年第8期36卷 2583-2587页

作者： Smith, Nathan J. Nance, Beth A. Durham, Lucian A., III McAlarnen, Lindsey A. Bishop, Erin A. Zundel, M. Tracy Med Coll Wisconsin Dept Surg Div Cardiothorac Surg 8701 Watertown Plank Rd Milwaukee WI 53226 USA Med Coll Wisconsin Dept Anesthesiol Div Crit Care Anesthesia Milwaukee WI 53226 USA Med Coll Wisconsin Dept Obstet & Gynecol Div Gynecol Oncol Milwaukee WI 53226 USA

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Fraction of expired oxygen: an additional safety approach to monitor oxygen delivery to the heart lung machine oxygenator

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PERFUSION-UK 2022年第4期37卷 331-333页

作者： Srey, Rithy Rance, Geoffrey Handrahan, John Smith, Trevor Leissner, Kay B. Zenati, Marco A. Vet Affairs Boston Healthcare Syst Div Cardiac Surg Boston MA USA Vet Affairs Boston Healthcare Syst Dept Anesthesiol & Crit Care Med Boston MA USA Harvard Med Sch Cambridge MA USA

Background: Monitoring oxygen delivery to the oxygenator of a heart lung machine (HLM) is typically accomplished with an O-2 analyzer connected to the gas inflow line. It is assumed when the FiO(2) is greater than 21% that oxygen is being delivered to the oxygenator. However, this assumption is imperfect because the connection of the inflow line to the oxygenator is downstream from the O-2 analyzer. FiO(2) monitoring will not alert the perfusionist if the inflow line is not actually connected to the oxygenator. Measuring the fraction of expired oxygen (FEO2) is a more reliable way of monitoring O-2 delivery. Methods: An O-2 analyzer was placed on the scavenging line that is attached to the exhaust port of oxygenator (FEO2). Results: Whenever the FiO(2) is greater than 21%, and the inflow line is properly connected, the FEO2 exiting the oxygenator is greater than 21%. The FEO2 falls to 21% when the inflow line is not functioning. Conclusion: Monitoring the FEO2 is a more reliable way to verify O-2 delivery to an oxygenator. An alarm can be set on the FEO2 monitor to alert the perfusionist if the FEO2 falls below a predetermined threshold so any issue with O-2 delivery will always be recognized.

关键词： cardiopulmonary bypass oxygenator perfusion patient safety

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Novel application of indocyanine green fluorescence imaging for real-time detection of thrombus in a membrane oxygenator

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ARTIFICIAL ORGANS 2021年第10期45卷 1173-1182页

作者： Sakurai, Hironobu Fujiwara, Tatsuki Ohuchi, Katsuhiro Hijikata, Wataru Inoue, Yusuke Seki, Haruna Tahara, Tomoki Yokota, Sachie Ogata, Asato Mizuno, Tomohiro Arai, Hirokuni Tokyo Med & Dent Univ Dept Cardiovasc Surg Grad Sch Med & Dent Sci Tokyo Japan Tokyo Med & Dent Univ Dept Adv Surg Technol Res & Dev Tokyo Japan Tokyo Inst Technol Sch Engn Tokyo Japan Asahikawa Med Univ Adv Med Engn Res Ctr Asahikawa Hokkaido Japan Tokyo Med & Dent Univ Fac Med Tokyo Japan

Extracorporeal membrane oxygenation (ECMO) plays an important role in the coronavirus disease 2019 (COVID-19) pandemic. Management of thrombi in ECMO is generally an important issue;especially in ECMO for COVID-19 patients who are prone to thrombus formation, the thrombus formation in oxygenators is an unresolved issue, and it is very difficult to deal with. To prevent thromboembolic complications, it is necessary to develop a method for early thrombus detection. We developed a novel method for detailed real-time observation of thrombi formed in oxygenators using indocyanine green (ICG) fluorescence imaging. The purpose of this study was to verify the efficacy of this novel method through animal experiments. The experiments were performed three times using three pigs equipped with veno-arterial ECMO comprising a centrifugal pump (CAPIOX SL) and an oxygenator (QUADROX). To create thrombogenic conditions, the pump flow rate was set at 1 L/min without anticoagulation. The diluted ICG (0.025 mg/mL) was intravenously administered at a dose of 10 mL once an hour. A single dose of ICG was 0.25mg. The oxygenator was observed with both an optical detector (PDE-neo) and the naked eye every hour after measurement initiation for a total of 8 hours. With this dose of ICG, we could observe it by fluorescence imaging for about 15 minutes. Under ICG imaging, the inside of the oxygenator was observed as a white area. A black dot suspected to be the thrombus appeared 6-8 hours after measurement initiation. The thrombus and the black dot on ICG imaging were finely matched in terms of morphology. Thus, we succeeded in real-time thrombus detection in an oxygenator using ICG imaging. The combined use of ICG imaging and conventional routine screening tests could compensate for each other's weaknesses and significantly improve the safety of ECMO.

关键词： acute animal experiment coronavirus disease 2019 extracorporeal membrane oxygenation indocyanine green fluorescence imaging indocyanine green oxygenator real-time thrombus detection thrombus

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