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Badania biozgodności in vitro polimerów konstrukcyjnych pompy wspomagania serca Religa Heart EXT, poddanych procesowi przetwórstwa

Kościelniak-Ziemniak M., Wilczek P., Kustosz R., Gonsior M.

Engineering of Biomaterials

2012

Vol. 15, no. 116-117 spec. iss.

57--61

Celem badań była ocena biozgodności w testach in vitro polimerów konstrukcyjnych polskiej pozaustrojowej pulsacyjnej pompy wspomagania serca Religa Heart EXT. Badaniu poddano próbki polimerów Bionate® II 90A, Bionate® II 55D i ChronoFlex® AR-LT przygotowane po procesach przetwórstwa, odpowiadających wytworzeniu pompy Religa Heart EXT. Przedmiotem badań była ocena oddziaływania polimerów na wybrane elementy komórkowe, takie jak: erytrocyty, płytki krwi i fibroblasty. Przeprowadzono testy hemolizy, trombogenności, cytotoksyczności oraz struktury chemicznej polimerów. Badania wykonano zgodnie z polską normą PN-EN ISO 10993. Rezultaty wykazały, że polimery konstrukcyjne po przetwórstwie nie oddziaływały negatywnie na elementy morfotyczne krwi, nie aktywowały płytek krwi i leukocytów oraz nie oddziaływały toksycznie na komórki fibroblastów. Ponadto, nie stwierdzono istotnych zmian w strukturze chemicznej polimerów konstrukcyjnych po procesie przetwórstwa technologicznego.

The aim of the investigations was in vitro biocompatibility evaluation of Polish extracorporeal pulsatile ventricular assist device Religa Heart EXT structural polymers. Samples of polymers: Bionate® II 90A, Bionate® 55D and ChronoFlex® AR-LT were tested, had been treated before with technological processes matching the conditions of Religa Heart EXT pump manufacturing. The subject of the investigation was the interaction between polymers and cellular elements (erythrocytes, platelets and fibroblasts). The following tests were performed: haemolysis, thrombogenicity, cytotoxicity and chemical structure analyses. The tests were performed according to Polish standard PN-EN ISO 10993. The results revealed: no negative interaction between blood cells and structural polymers, after technological process; no activation of platelets and leukocytes, and no fibroblasts toxicity. Furthermore, no essential changes in the chemical structure of the examined polymers after technological process were observed.

Stereoscopic particle image velocimetry for application in three-dimensional flow within a spiral vortex pulsatile blood pump

Yagi T., Yang W., Ishikawa D., Iwasaki K., Umezu M.

Biocybernetics and Biomedical Engineering

2006

Vol. 26, no. 2

53-62

There is currently no multidimensional flow diagnostic tool developed which is capable of elucidating 3D complex flow structures in pulsatile ventricular assist devices (VAD). According to recent clinical reports, most VAD may have a persistent risk of thromboembolism even in administration of systematic medical therapy. The present study, therefore, aims to demonstrate the applicability of Stereoscopic ParticIe Image Velocimetry (SPIV) for characterizing highly 3D complex flows within a pulsatile blood pump. SPIV measurements were carried out within a Spiral Vortex pulsatile blood pump (SV pump). In order to assess the measurement accuracy, the results were compared with those obtained with Laser Doppler Anemometry (LDA). In experiments, a full-scale Perspex model of the SV pump was employed. A Newtonian blood-analog fluid was used with the approximately same refractive index as the Perspex. A flow rate was set at 8.3 L/min (Re=2500) under steady conditions. SPIV measurements revealed 3D complex flow characteristics of a steady swirling flow generated within a conical housing. The flow, similar to a model of Rankine vortex, exhibited intricate natures in a three-dimensional manner, particularly in a core region at the swirling center and in the immediate downstream of inlet flow. In measurement comparisons, the results of SPIV measurements were in agreement with those from LDA. These results successfully demonstrated the viability as well as the efficacy of SPIV measurement in investigating 3D complex flows within the SV pump.