Development of a Membrane Oxygenator for Long-Term Respiratory Support and Its Experimental Evaluation in Prolonged ECMO

Eya, Kazuhiro; Tatsumi, Eisuke; Taenaka, Yoshiyuki; Takewa, Yoshiaki; Wakisaka, Yoshinari; Toda, Köichi; Nakatani, Takeshi; Masuzawa, Takahisa; Baba, Yoshiyasu; Miyazaki, Kôji; Nishimura, Takashi; Ohno, Takashi; Ahn, Jae Mok; Takano, Hisateru; Mimura, Rishichi; Tanaka, Soichi; Wada, Toru

doi:10.1097/00002480-199609000-00107

Cited by 12 publications

(3 citation statements)

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“…We have previously developed hydrodynamically levitated centrifugal pump, membrane oxygenator with hollow polyolefin fibers, and coating technique, and demonstrated its biocompatibility in 30-day animal experiments. All of these elements are installed on the present system [9][10][11]. Especially, the pump of the system which employs hydrodynamic levitation systems is expected to exhibit superior anti-thrombogenicity compared to conventional pivot-bearing pumps.…”

Section: Technical Elements To Achieve Anti-thrombogenicity In This Ecmo Systemmentioning

confidence: 99%

“…For the former problem, we have previously developed ECMO system which consists of a hydrodynamically levitated centrifugal pump (BIOFLOAT-NCVC) [9], a membrane oxygenator with hollow polyolefin fibers (BIOCUBE-NCVC) [10,11], and a circuit treated with a heparin-bonding material (T-NCVC coating) [10,11]. Its preclinical study has already been done for without the administration of heparin for 30 days, and revealed its good performance [9].…”

Section: Introductionmentioning

confidence: 99%

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Preclinical biocompatibility study of ultra-compact durable ECMO system in chronic animal experiments for 2 weeks

et al. 2020

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Although the innovation has come in ECMO field, many problems remain unresolved. One of the main problems is about long-term durability and biocompatibility. Another is the system's size, weight, and its complicated equipment. For the former problem, we have previously developed ECMO system which consists of a tiny, hydrodynamically levitated centrifugal pump (BIOFLOAT-NCVC), a membrane oxygenator with hollow polyolefin fibers (BIOCUBE-NCVC), and the circuit treated with a heparin-bonding material (T-NCVC coating), and reported three cases of animal experiments for 30-day heparin-free drive. For the latter problem, we have integrated these elements to the compact system with sensors of temperature, pressure, and SvO 2 , and blood flow. Its installation area is 595 cm 2 , weighs 8.9 kg with attachable oxygen cassette, and battery which could last an hour at least. To evaluate the biocompatibility of this system, this ECMO was installed in four goats. Scheduled duration was 14 days. Heparin was continuously infused to control their ACT between 150 and 200 s except one 2-week experiment without systemic heparinization. All of the four goats survived till the scheduled termination. Function of the pump and the oxygenator during ECMO was stable. No obvious adverse events were observed. All lab data were of normal range after 1 week. Small infarctions were found at kidneys, but they were not clinically significant. No thrombus was found in the pump system. The oxygenators were extremely clean except a little thrombus formation; while, the heparin-free examination revealed acceptable cleanliness. The present study revealed good anti-thrombogenicity of this ultra-compact durable ECMO system with heparinization. Our system encourages awake and extubated management, rehabilitation, interhospital transfer, and prehospital initiation of ECMO.

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Section: Technical Elements To Achieve Anti-thrombogenicity In This Ecmo Systemmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Preclinical biocompatibility study of ultra-compact durable ECMO system in chronic animal experiments for 2 weeks

et al. 2020

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“…Clots are often found at the cross-sectional expansion in the inlet region [11][12][13]. Additionally, the corners have proven to be particularly prone to clotting due to an uneven flow distribution resulting in low flow regimes in the corners [8,11]. The corners can be eliminated, for (Eurosets, S.r.I., Medolla, Italy)] and a stacked, cuboidal-shaped ML (right) [e.g., iLA membrane ventilator (Xenios AG, Heilbronn, Germany) or Quadrox-i (Maquet GmbH, Rastatt, Germany)].…”

Section: Introductionmentioning

confidence: 99%

Introducing 3D-potting: a novel production process for artificial membrane lungs with superior blood flow design

et al. 2021

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Currently, artificial-membrane lungs consist of thousands of hollow fiber membranes where blood flows around the fibers and gas flows inside the fibers, achieving diffusive gas exchange. At both ends of the fibers, the interspaces between the hollow fiber membranes and the plastic housing are filled with glue to separate the gas from the blood phase. During a uniaxial centrifugation process, the glue forms the “potting.” The shape of the cured potting is then determined by the centrifugation process, limiting design possibilities and leading to unfavorable stagnation zones associated with blood clotting. In this study, a new multiaxial centrifugation process was developed, expanding the possible shapes of the potting and allowing for completely new module designs with potentially superior blood flow guidance within the potting margins. Two-phase simulations of the process in conceptual artificial lungs were performed to explore the possibilities of a biaxial centrifugation process and determine suitable parameter sets. A corresponding biaxial centrifugation setup was built to prove feasibility and experimentally validate four conceptual designs, resulting in good agreement with the simulations. In summary, this study shows the feasibility of a multiaxial centrifugation process allowing greater variety in potting shapes, eliminating inefficient stagnation zones and more favorable blood flow conditions in artificial lungs. Graphic abstract

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Preclinical study of a novel hydrodynamically levitated centrifugal pump for long-term cardiopulmonary support

et al. 2015

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An extracorporeal centrifugal blood pump with a hydrodynamically levitated impeller was developed for use in a durable extracorporeal membrane oxygenation (ECMO) system. The present study examined the biocompatibility of the blood pump during long-term use by conducting a series of 30-day chronic animal experiments. The ECMO system was used to produce a percutaneous venoarterial bypass between the venae cavae and carotid artery in adult goats. No anticoagulation or antiplatelet therapy was administered during the experiments. Three out of four animals survived for the scheduled 30-day period, and the blood pumps and membrane oxygenators both exhibited sufficient hydrodynamic performance and good antithrombogenicity, while one animal died of massive bleeding from the outflow cannulation site. The animals' plasma free hemoglobin had returned to within the normal range by 1 week after the surgical intervention, and their hemodynamic and biochemistry parameters remained within their normal ranges throughout the experiment. The explanted centrifugal blood pumps did not display any trace of thrombus formation. Based on the biocompatibility demonstrated in this study, the examined centrifugal blood pump, which includes a hydrodynamically levitated impeller, is suitable for use in durable ECMO systems.

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Development of a Membrane Oxygenator for Long-Term Respiratory Support and Its Experimental Evaluation in Prolonged ECMO

Cited by 12 publications

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Preclinical biocompatibility study of ultra-compact durable ECMO system in chronic animal experiments for 2 weeks

Preclinical biocompatibility study of ultra-compact durable ECMO system in chronic animal experiments for 2 weeks

Introducing 3D-potting: a novel production process for artificial membrane lungs with superior blood flow design

Preclinical study of a novel hydrodynamically levitated centrifugal pump for long-term cardiopulmonary support

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