Menu

A+ A A-

Download article

DOI: https://doi.org/10.22263/2312-4156.2025.2.114

L.G. Lappo, V.A. Hrynchak, S.I. Sychik
In vitro hemocompatibility of medical devices with different duration and type of contact with a patient
Republican Center for Hygiene, Epidemiology and Public Health, Minsk, Republic of Belarus

Vestnik VGMU. 2025;24(2):114-123.

Abstract. 
The aim of the work was to study the in vitro hemocompatibility of medical devices with different duration and type of contact with a patient using a test model of the artificial blood flow. An in vitro test model of the artificial blood flow with the whole heparinized human blood was used. After incubation in the test model for 20, 60 and 120 minutes, the following blood parameters were determined: the number of platelets and leukocytes, the content of the prothrombin fragment F1+2, thrombin-antithrombin complex III, beta-thromboglobulin, thromboxane B2 and protein C3a of the complement system.
All the studied medical devices after incubation for 20 minutes were found to have high hemocompatibility. With an increase in the incubation time to 120 minutes, the compatibility of medical device samples with blood decreased. After 60 minutes of incubation in a test model of the artificial blood flow of the medical devices including intrauterine device (polyethylene), surgical mesh (polypropylene) and needle (stainless steel) statistically significant changes in the morphofunctional parameters of blood were observed, which underwent even more pronounced negative changes after increasing the incubation time to 120 minutes. For devices having constant contact with the internal body environment, high compatibility with blood was established, which did not depend on the incubation time in the in vitro test model of the artificial blood flow.
Keywords: hemocompatibility, medical devices, coagulation markers, platelet activation, in vitro test model, whole human blood.

The sources of funding. The study was carried out within the framework of the task 04.08. “Develop a method for assessing the in vitro hemocompatibility of medical devices based on a test model of artificial blood flow” of the State Scientific and Technical Program “Scientific and Technical Support for the Quality and Availability of Medical Services” for 2021-2025, subprogram “Safety of the Human Environment” (state registration number 20220371 dated March 28, 2022).

References

1. ISO 10993-4:2017. Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood. Geneva; 2017. 69 p.
2. Blok SLJ, van Oeveren W, Engels GE. The optimal incubation time for in vitro hemocompatibility testing: Assessment using polymer reference materials under pulsatile flow with physiological wall shear stress conditions. Journal Biomedical Materials Research Part B Applied Biomaterials. 2019 Oct;107(7):2335-2342. doi: http://dx.doi.org/10.1002/jbm.b.34326 
3. Engels GE, Blok SLJ, van Oeveren W. In vitro blood flow model with physiological wall shear stress for hemocompatibility testing-An example of coronary stent testing. Biointerphases. 2016 Sep;11(3):031004. doi: http://dx.doi.org/10.1116/1.4958979 
4. Sevastyanov VI, Perova NV, Arzumanyants EV, Perova NM. Biosafety assessment of medical devices (analytical review). Perspektivnye Materialy. 2024;(4):17-30. (In Russ.)
5. Bhatt A, Ramakrishnan R, Raju R, R. Geevarghese, P. Lekshmi. Product evaluation: blood compatibility studies. In: Mohanan PV, ed. Biomedical product and materials evaluation. Sawston; 2022. P. 435-459. doi: http://dx.doi.org/10.1016/B978-0-12-823966-7.00022-0 
6. Link A, Cattaneo G, Brynda E, T. Riedel, J. Kucerova, C. Schlensak, et al. Hemocompatibility testing of blood-contacting implants in a flow loop model mimicking human blood flow. Journal Visualized Experiments. 2020 Mar:157. doi: http://dx.doi.org/10.3791/60610 
7. Jaffer IH, Weitz JI. The blood compatibility challenge. Part 1: blood-contacting medical devices: the scope of the problem. Acta Biomaterialia. 2019 Aug:94:2-10. doi: http://dx.doi.org/10.1016/j.actbio.2019.06.021 
8. Il'yukova II, Petrova SYu, Gomolko TN, Boris OA, Anisovich MV, Grynchak VA, razrab. Methods of hygienic evaluation of medical devices: instruktsiya po primeneniyu № 020-1118: utv Gl gos sanitar vrachom Resp Belarus' 23.04.2019 g. Minsk, RB; 2019. 56 р. (In Russ.)
9. Braune S, Lendlein A, Jung F. Developing standard and test protocols for testing the hemocompatibility of biomaterials. Siedlecki C, ed. In: Hemocompatibility of biomaterials for clinical applications: blood - biomaterials interaction. Duxford, United Kingdom: United Kingdom Woodhead Publishing; 2018. P. 51-76. doi: http://dx.doi.org/10.1016/B978-0-08-100497-5.0000
10. Weber M, Steinle H, Golombek S, Hann L, Schlensak C, Wendel HP, et al. Blood-contacting biomaterials: in vitro evaluation of the hemocompatibility. Frontiers Bioengineering Biotechnology. 2018 Jul:6:99. doi: http://dx.doi.org/10.3389/fbioe.2018.00099 
11. Mohan CC, Chennazhi KP, Menon D. In vitro hemocompatibility and vascular endothelial cell functionality on titania nanostructures under static and dynamic conditions for improved coronary stenting applications. Acta Biomaterialia. 2013 Dec;9(12):9568-9577. doi: http://dx.doi.org/10.1016/j.actbio.2013.08.023 
12. Munch K, Wolf MF, Gruffaz P, Ottenwaelter C, Bergan M, Schroeder P, et al. Use of simple and complex in vitro models for multiparameter characterization of human blood-material/device interactions. Journal Biomaterials Science Polymer Edition. 2000;11(11):1147-1163. doi: http://dx.doi.org/10.1163/156856200744246 
13. Lappo LG, Sychik SI, Grynchak VA. Development of a dynamic in vitro test model of artificial blood flow to assess hemocompatibility of medical devices. V: Sychik SI, red. Zdorov'e i okruzhayushchaya sreda: sb nauch tr. Gomel', RB: Redaktsiya gazety «Gomel'skaya praўda»; 2024. Vyp 34. Р. 237-245. (In Russ.)
14. Lappo LG, Sychik SI, Grynchak VA. Use of whole conserved blood for in vitro evaluation of hemocompatibility of medical devices. V: Sychik SI, red. Zdorov'e i okruzhayushchaya sreda: sb nauch tr. Gomel', RB: Redaktsiya gazety «Gomel'skaya praўda»; 2024. Vyp 34. Р. 246-253. (In Russ.)
15. Lappo LG, Sychik SI, Grynchak VA. A dynamic test model for evaluating the hemocompatibility of medical devices. V: Sychik SI, red. Zdorov'e i okruzhayushchaya sreda: sb materialov mezhdunar nauch-prakt konf, Minsk, 5-6 dek 2024 g. Gomel', RB: Redaktsiya gazety «Gomel'skaya praўda»; 2024. Р. 248-252. (In Russ.)

Submitted 06.02.2025
Accepted 14.04.2025

Information about authors:
Lidziya G. Lappo ‒ rresearcher, laboratory of preventive and environmental toxicology Research Institute of Hygiene, Toxicology, Epidemiology, Virology and Microbiology, Republican Center for Hygiene, Epidemiology and Public Health, https://orcid.org/0009-0009-0312-3982, e-mail: Этот адрес электронной почты защищён от спам-ботов. У вас должен быть включен JavaScript для просмотра.;
V.A. Hrynchak ‒ Candidate of Medical Sciences, head of the laboratory of applied toxicology and safety of medical products, Research Institute of Hygiene, Toxicology, Epidemiology, Virology and Microbiology, Republican Center for Hygiene, Epidemiology and Public Health, https://orcid.org/0000-0002-4119-1793
S.I. Sychik ‒ Candidate of Medical Sciences, Associate Professor, Director Research Institute of Hygiene, Toxicology, Epidemiology, Virology and Microbiology, Republican Center for Hygiene, Epidemiology and Public Health, https://orcid.org/0000-0002-5493-9799

Поиск по сайту