Silicone-Coated Polypropylene Hollow-Fiber Oxygenator: Experimental Evaluation and Preliminary Clinical Use

Shimono, Takatsugu; Shomura, Yu; Hioki, Iwao; Shimamoto, Akira; Tenpaku, Hironori; Maze, Yasumi; Onoda, Koji; Takao, Motoshi; Shimpo, Hideto; Yada, Isao

doi:10.1016/s0003-4975(97)00119-7

Cited by 44 publications

(21 citation statements)

References 10 publications

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“…Intravascular hemolysis in patients with paroxysmal nocturnal hemoglobinuria produces abdominal pain, gastric and esophageal dystonia, and erectile dysfunction, with levels of plasma Hb ranging from 30 to 120 µM (in heme concentration) and up to 600 µM during paroxysms of hemolysis (28). During cardiopulmonary bypass, the levels of plasma oxyheme can rise to 150 µM (29)(30)(31)(32). The present studies suggest that these pathologically relevant levels of hemoglobinemia may be associated with endogenous NO inhibition, a vasopressor effect, and impaired organ function.…”

Section: Figurementioning

confidence: 99%

Hemolysis-associated endothelial dysfunction mediated by accelerated NO inactivation by decompartmentalized oxyhemoglobin

Minneci¹

2005

Journal of Clinical Investigation

287

240

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During intravascular hemolysis in human disease, vasomotor tone and organ perfusion may be impaired by the increased reactivity of cell-free plasma hemoglobin (Hb) with NO. We experimentally produced acute intravascular hemolysis in a canine model in order to test the hypothesis that low levels of decompartmentalized or cell-free plasma Hb will severely reduce NO bioavailability and produce vasomotor instability. Importantly, in this model the total intravascular Hb level is unchanged; only the compartmentalization of Hb within the erythrocyte membrane is disrupted. Using a full-factorial design, we demonstrate that free waterinduced intravascular hemolysis produces dose-dependent systemic vasoconstriction and impairs renal function. We find that these physiologic changes are secondary to the stoichiometric oxidation of endogenous NO by cell-free plasma oxyhemoglobin. In this model, 80 ppm of inhaled NO gas oxidized 85-90% of plasma oxyhemoglobin to methemoglobin, thereby inhibiting endogenous NO scavenging by cell-free Hb. As a result, the vasoconstriction caused by acute hemolysis was attenuated and the responsiveness to systemically infused NO donors was restored. These observations confirm that the acute toxicity of intravascular hemolysis occurs secondarily to the accelerated dioxygenation reaction of plasma oxyhemoglobin with endothelium-derived NO to form bioinactive nitrate. These biochemical and physiological studies demonstrate a major role for the intact erythrocyte in NO homeostasis and provide mechanistic support for the existence of a human syndrome of hemolysis-associated NO dysregulation, which may contribute to the vasculopathy of hereditary, acquired, and iatrogenic hemolytic states. Introduction NO is continuously synthesized from endothelium and regulates homeostatic vascular functions such as vasodilation, inhibition of platelet activation and thrombosis, inhibition of endothelial adhesion molecule and endothelin-1 expression, and modulation of intimal and smooth muscle proliferation (1-5). A paradox and controversy in vascular biology surrounds the near diffusion-limited dioxygenation reaction of NO with oxyhemoglobin that oxidizes NO to nitrate, an inactive metabolite (Reaction 1).

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Section: Figurementioning

confidence: 99%

Hemolysis-associated endothelial dysfunction mediated by accelerated NO inactivation by decompartmentalized oxyhemoglobin

Minneci¹

2005

Journal of Clinical Investigation

287

240

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“…Though the fibers are made of a hydrophobic polymer to reduce blood plasma leakage into the fiber wall, phospholipids, lipoproteins and proteins from the plasma inevitably penetrate the submicrometer pores over time, reducing the membrane gas permeability, which can cause device failure within days (Montoya et al 1992;Federspiel and Henchir 2004). To prevent plasma leakage, some ECMO membranes are coated with a thin non-porous polymer such as silicone (Shimono et al 1997), which increases cost and reduces oxygen permeance of the membrane (Niimi et al 1997). Adverse interactions between blood and the device tubing, made of polyvinylchloride (PVC), Tygon or silicone, increases the risk of thrombosis, requiring a high level of anticoagulant administration, which can cause excessive bleeding and electrolyte-related imbalances in the patient (Stiller et al 2004;Brand 2009).…”

Section: Introductionmentioning

confidence: 99%

A microfluidic respiratory assist device with high gas permeance for artificial lung applications

Kniazeva

Hsiao

Charest

et al. 2010

Biomed Microdevices

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One of the principal challenges in artificial lung technology has been the ability to provide levels of oxygen and carbon dioxide exchange that rival those of the natural human lung, while mitigating the deleterious interaction between blood and the surface of the synthetic gas exchange membrane. This interaction is exacerbated by the large oxygenator surface area required to achieve sufficient levels of gas transfer. In an effort to address this challenge, microfluidics-based artificial lung technologies comprising stacked microchannel networks have been explored by several groups. Here we report the design, fabrication and initial testing of a parallel plate multilayered silicone-based microfluidic construct containing ultrathin gas exchange membranes, aimed at maximizing gas transfer efficiency while minimizing membrane-blood contact area. The device comprises a branched microvascular network that provides controlled wall shear stress and uniform blood flow, and is designed to minimize blood damage, thrombosis and inflammatory responses seen in current oxygenators. Initial testing indicates that flow distribution through the multilayer structure is uniform and that the thin membrane can withstand pressures equivalent to those expected during operation. Oxygen transfer using phosphate buffered saline as the carrier fluid has also been assessed, demonstrating a sharp increase in oxygen transfer as membrane thickness is reduced, consistent with the expected values of oxygen permeance for thin silicone membranes.

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“…A membrane oxygenator (Excelung Binding Prime) consisting of microporous polypropylene hollow fibers was previously developed by the MERA Co. (Tokyo, Japan); in this oxygenator, the blood contact surface was coated with a 0.2 µm ultrathin silicone layer. A clinical study of this oxygenator demonstrated good gas transfer, acceptable pressure loss, low hemolysis, and good durability (19). Recently, a new heparin‐coated membrane oxygenator based on the Excelung Binding Prime was developed.…”

Section: Discussionmentioning

confidence: 99%

Comparison of a New Heparin‐coated Dense Membrane Lung with Nonheparin‐coated Dense Membrane Lung for Prolonged Extracorporeal Lung Assist in Goats

et al. 2004

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Thrombosis and bleeding are major complications in cases of prolonged extracorporeal lung assist (ECLA) with an artificial-membrane lung. Antithrombogenic treatment of the artificial-membrane oxygenator and circuits is indispensable for safe ECLA. The efficacy of a new heparin-coated membrane lung with minimal systemic heparinization was evaluated for 7 days and compared with a nonheparin-coated membrane lung in goats. The animals were randomly assigned to either the heparin-coated membrane group (HM group, n = 5) or nonheparin-coated membrane group (NHM group, n = 5). Activated coagulation time (ACT) during ECLA was controlled to below 150 s in the HM group, and to near 200 s in the NHM group. All goats in the HM group were sustained on ECLA for 7 days, but two goats in the NHM group died on the 4th and 6th days, respectively. The mean systemic administration rate of heparin during ECLA was 22.4 +/- 4.4 U/kg/h in the HM group and 39.0 +/- 10.0 U/kg/h in the NHM group. There was a significant difference between the two groups (P < 0.05). The oxygen transfer rate, the Pco(2) difference, the perfusion resistance, and platelet counts showed no significant changes. There was no plasma leakage from the artificial lung. Although several clots were observed in the stagnant areas of the artificial lung, they did not lead to deterioration of the function of the artificial lung. The excellent antithrombogenicity, gas exchange ability, and durability of this new artificial lung with circuits might contribute to successful prolonged ECLA with minimal systemic heparinization.

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Silicone-Coated Polypropylene Hollow-Fiber Oxygenator: Experimental Evaluation and Preliminary Clinical Use

Cited by 44 publications

References 10 publications

Hemolysis-associated endothelial dysfunction mediated by accelerated NO inactivation by decompartmentalized oxyhemoglobin

Hemolysis-associated endothelial dysfunction mediated by accelerated NO inactivation by decompartmentalized oxyhemoglobin

A microfluidic respiratory assist device with high gas permeance for artificial lung applications

Comparison of a New Heparin‐coated Dense Membrane Lung with Nonheparin‐coated Dense Membrane Lung for Prolonged Extracorporeal Lung Assist in Goats

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