The purpose of this study was to clarify the effect of the reducing agent on the oxygen-inhibited layer of the cross-linked reline material. A commercial autopolymerizing reline resin containing 1,6-hexanediol dimethacrylate as cross-linking agent and 1 wt.% sodium sulphite solution as a reducing agent was prepared. The inhibited layer was observed using an optical transmission microscope under the conditions of the application of sodium sulphite for 0, 1, 5 and 15 min after curing for 10 min in air. As a control, the reline material was cured on sealing from air. Moreover, the three-point flexural strength test was performed under the same conditions. The fracture was then observed using scanning electron microscopy (SEM). Although hardness of the inhibited layer was enhanced after the application of the reducing agent, the layer was still observed. The flexural strength of the control and the groups after application of the reducing agent was significantly higher than the group without reducing agent. SEM examination revealed many polymer beads on the group without reducing agent, whereas polymer beads could not be observed on the groups applying the reducing agent. These results indicated that the application of sodium sulphite was effective in hardening the surface unpolymerized zone.

Pump thrombosis induces significant complications and requires timely detection. We proposed real‐time monitoring of pump thrombus in a magnetically levitated centrifugal blood pump (mag‐lev pump) without using additional sensors, by focusing on the changes in the displacement of the pump impeller. The phase difference between the current and displacement of the impeller increases with pump thrombus. This thrombus detection method was previously evaluated through simulated circuit experiments using porcine blood. Evaluation of real‐time thrombus detection in a mag‐lev blood pump was performed using a porcine left ventricular assist circulation model in this study. Acute animal experiments were performed five times using five Japanese domestic pigs. To create thrombogenic conditions, fibrinogen coating that induces thrombus formation in a short time was applied to the inner surfaces of the pump. An inflow and an outflow cannula were inserted into the apex of the left ventricle and the carotid artery, respectively, by a minimally invasive surgical procedure that allowed minimal bleeding and hypothermia. Pump flow was maintained at 1 L/min without anticoagulation. The vibrational frequency of the impeller (70 Hz) and its vibrational amplitude (30 μm) were kept constant. The thrombus was detected based on the fact that the phase difference between the impeller displacement and input current to the magnetic bearing increases when a thrombus is formed inside a pump. The experiment was terminated when the phase difference increased by over 1° from the lowest value or when the phase difference was at the lowest value 12 hours after commencing measurements. The phase difference increased by over 1° in three cases. The pump was stopped after 12 hours in two cases. Pump thrombi were found in the pump in three cases in which the phase difference increased by over 1°. No pump thrombus was found in the other two cases in which the phase difference did not increase. We succeeded in real‐time thrombus monitoring of a mag‐lev pump in acute animal experiments.

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.

Although the magnetically levitated centrifugal blood pump (mag‐lev pump) is considered superior to other pumps in antithrombogenicity, thrombotic complications are still reported. Research into thrombus detection inside a mag‐lev pump is very important for solving this problem. Our research group has already proposed a method to detect a thrombus inside a mag‐lev pump in real time without an additional sensor, which is named the impeller vibration method. To efficiently advance our research with reproducibility, a preconditioning method to induce thrombus inside the pump was thought to be necessary. Therefore, this study aimed to develop a preconditioning method that induces thrombus formation. To verify this method, in vitro experiments for thrombus detection were performed. A mag‐lev pump developed at Tokyo Institute of Technology was used. A fibrinogen solution was coated on the inner surfaces of the bottom housing to induce thrombus formation at the target point inside the pump. The thrombus is detected by utilizing the phenomenon that the phase difference between the impeller displacement and input current to the magnetic bearing increases when a thrombus is formed inside a pump. Five hundred mL of porcine blood anticoagulated with heparin sodium was circulated in the mock circuit, and protamine sulfate was administered. Flow rate (1 L/min), impeller vibrational frequency (70 Hz), and vibrational amplitude (30 µm) were set to constant. The experiment was terminated when the phase difference increased by over 2° from the minimum value. The experiments were performed in fibrinogen‐coated (group F, n = 5) and non‐coated pumps (group N, n = 5). In group F, thrombus formation was observed at the fibrinogen‐coated point of the housing. In contrast, a relatively small thrombus was observed in varying locations such as the housing or the impeller in group N. Thrombus formation time (the time from when the phase difference takes the minimum value to when the experiment is terminated) was different between the two groups. The mean time was significantly shorter in group F (44 ± 29 minutes) than in group N (143 ± 38 minutes; p = 0.0019). Therefore, a preconditioning method that induced thrombus formation at the target point inside a blood pump was successfully developed.

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