Design of a benchmark pump model and optimization of hemolysis testing protocol for evaluation of blood pump hemocompatibility_Journal of Biomedical Engineering

Authors：

WANG Xiaodong ^1,2 , DU Guanting ¹ ,  ZHANG Liudi ¹ , LI Shu ³ ,  WU Peng ^2,4

1. Artificial Organ Technology Laboratory, School of Mechanical and Electrical Engineering, Soochow University, Suzhou, Jiangsu 215131, P. R. China;
2. Jiangsu Province Key Laboratory of Precision Medicine Equipment Design and Manufacturing, School of Mechanical Engineering, Southeast University, Nanjing 211189, P. R. China;
3. Institute for Medical Devices Control, National Institutes for Food and Drug Control, Beijing 102629, P. R. China;
4. Precision and Intelligence Medical Imaging Lab, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, P. R. China;

Corresponding?author：

ZHANG Liudi, Email: liudi@suda.edu.cn; WU Peng, Email: 101013707@seu.edu.cn

Keywords：

Blood pump; Hemocompatibility; In vitro hemolysis testing; Control group; Uncertainty; Benchmark model

DOI：

10.7507/1001-5515.202503047

Video：

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In vitro hemolysis testing for blood pumps currently faces several challenges, including randomness in control group selection, and numerous sources of uncertainty in the testing methods. These issues lead to high uncertainty, insufficient result credibility, and limited comparability, which hinders the effective evaluation of blood damage induced by blood pumps. This study aims to address these limitations by developing a magnetically-levitated blood pump benchmark model and optimizing the hemolysis testing protocol to reduce result uncertainty. A magnetic bearing was utilized to minimize blood damage, and the injection molding was employed to enhance the machining precision of the pump. The experimental procedures, including blood collection, test loop setup, and the testing process, were optimized to effectively control experimental uncertainty. The results showed that the performance curve of the benchmark pump model was flat, and the coefficient of variation for the hydraulic experimental results was less than 5%. The secondary flow path exhibited good blood washout with no thrombus formation. Under low-flow condition, the average normalized index of hemolysis (NIH) was 0.014 g/100L, with a coefficient of variation of 19.50%. Under high-flow condition, the average NIH was 0.045 g/100L, with a coefficient of variation of 16.45%. The hemolysis values under both conditions were lower than the Abbott CentriMag. In conclusion, we designed a benchmark blood pump model with excellent hemocompatibility and optimized hemolysis testing protocol, which led to low uncertainty in experimental results. The benchmark and optimized hemolysis protocol help to improve the credibility and comparability of in vitro hemolysis testing data, providing a reliable solution for both the industry and regulatory agencies to assess hemocompatibility.

Citation： WANG Xiaodong, DU Guanting, ZHANG Liudi, LI Shu, WU Peng. Design of a benchmark pump model and optimization of hemolysis testing protocol for evaluation of blood pump hemocompatibility. Journal of Biomedical Engineering, 2026, 43(1): 106-113. doi: 10.7507/1001-5515.202503047 Copy

1.	American Society for Testing and Materials. ASTM F1841-19e1. Standard practice for assessment of hemolysis in continuous flow blood pumps. West Conshohocken: ASTM, 2021.
2.	國家藥品監督管理局, 全國醫用體外循環設備標準化技術委員會. YY/T 1620-2018心肺轉流系統連續流血泵紅細胞損傷評價方法. 北京: 中國標準出版社, 2018.
3.	Chan C H H, Pieper I L, Robinson C R, et al. Shear stress‐induced total blood trauma in multiple species. Artif Organs, 2017, 41(10): 934-947.
4.	Mueller M R, Schima H, Engelhardt H, et al. In vitro hematological testing of rotary blood pumps: remarks on standardization and data interpretation. Artif Organs, 1993, 17(2): 103-110.
5.	Chiu W, Alemu Y, McLarty A, et al. Ventricular assist device implantation configurations impact overall mechanical circulatory support system thrombogenic potential. ASAIO J, 2017, 63(3): 285-292.
6.	Kazui T, Zhang A, Greenberg J, et al. Left ventricular assist device inflow angle and pump positional change over time adverse impact on left ventricular assist device function. Ann Thorac Surg, 2016, 102(6): 1933-1940.
7.	Li M, Walk R, Roka-Moiia Y, et al. Circulatory loop design and components introduce artifacts impacting in vitro evaluation of ventricular assist device thrombogenicity: A call for caution. Artif Organs, 2020, 44(6): E226-E237.
8.	Herbertson L, Olia S, Daly A, et al. Multilaboratory study of flow-induced hemolysis using the FDA benchmark nozzle model. Artif Organs, 2014, 39(3): 237-248.
9.	Wu P, Bai Y, Du G, et al. Resistance valves in circulatory loops have a significant impact on in vitro evaluation of blood amage caused by blood pumps: a computational study. Front Physiol, 2023, 14: 1287207.
10.	戴偉峰. 考慮湍流影響的磁懸浮離心式血泵多目標優化設計研究. 蘇州: 蘇州大學, 2021.
11.	潘志剛. 考慮湍流模擬方法與轉子軸向位置的磁懸浮血泵性能評估與優化設計研究. 蘇州: 蘇州大學, 2024.
12.	Wu P, Huo J, Dai W, et al. On the optimization of a centrifugal maglev blood pump through design variations. Front Physiol, 2021, 12: 699891.
13.	Blum C, Landoll M, Strassmann S E, et al. Blood trauma in veno-venous extracorporeal membrane oxygenation: low pump pressures and low circuit resistance matter. Crit Care, 2024, 28(1): 330.
14.	Wu P, Huo J D, Zhang Z J, et al. The influence of non-conformal grid interfaces on the results of large eddy simulation of centrifugal blood pumps. Artif Organs, 2022, 46(9): 1804-1816.
15.	Wu P, Gao Q, Hsu P L. On the representation of effective stress for computing hemolysis. Biomech Model Mechan, 2019, 18(3): 665-679.
16.	Garon A, Farinas M I. Fast three‐dimensional numerical hemolysis approximation. Artif Organs, 2004, 28(11): 1016-1025.
17.	Ding J, Niu S, Chen Z, et al. Shear-induced hemolysis: species differences. Artif Organs, 2015, 39(9): 795-802.
18.	葛婉寧, 梅旭, 張柳笛. 心室輔助裝置溶血測試中游離血紅蛋白檢測方法比較. 北京生物醫學工程, 2024, 43(5): 500-505.
19.	Malinauskas R A, Hariharan P, Day S W, et al. FDA benchmark medical device flow models for CFD validation. ASAIO J, 2017, 63(2): 150-160.
20.	Li P, Mei X, Ge W, et al. A comprehensive comparison of the in vitro hemocompatibility of extracorporeal centrifugal blood pumps. Front Physiol, 2023, 14: 1136545.

1. American Society for Testing and Materials. ASTM F1841-19e1. Standard practice for assessment of hemolysis in continuous flow blood pumps. West Conshohocken: ASTM, 2021.
2. 國家藥品監督管理局, 全國醫用體外循環設備標準化技術委員會. YY/T 1620-2018心肺轉流系統連續流血泵紅細胞損傷評價方法. 北京: 中國標準出版社, 2018.
3. Chan C H H, Pieper I L, Robinson C R, et al. Shear stress‐induced total blood trauma in multiple species. Artif Organs, 2017, 41(10): 934-947.
4. Mueller M R, Schima H, Engelhardt H, et al. In vitro hematological testing of rotary blood pumps: remarks on standardization and data interpretation. Artif Organs, 1993, 17(2): 103-110.
5. Chiu W, Alemu Y, McLarty A, et al. Ventricular assist device implantation configurations impact overall mechanical circulatory support system thrombogenic potential. ASAIO J, 2017, 63(3): 285-292.
6. Kazui T, Zhang A, Greenberg J, et al. Left ventricular assist device inflow angle and pump positional change over time adverse impact on left ventricular assist device function. Ann Thorac Surg, 2016, 102(6): 1933-1940.
7. Li M, Walk R, Roka-Moiia Y, et al. Circulatory loop design and components introduce artifacts impacting in vitro evaluation of ventricular assist device thrombogenicity: A call for caution. Artif Organs, 2020, 44(6): E226-E237.
8. Herbertson L, Olia S, Daly A, et al. Multilaboratory study of flow-induced hemolysis using the FDA benchmark nozzle model. Artif Organs, 2014, 39(3): 237-248.
9. Wu P, Bai Y, Du G, et al. Resistance valves in circulatory loops have a significant impact on in vitro evaluation of blood amage caused by blood pumps: a computational study. Front Physiol, 2023, 14: 1287207.
10. 戴偉峰. 考慮湍流影響的磁懸浮離心式血泵多目標優化設計研究. 蘇州: 蘇州大學, 2021.
11. 潘志剛. 考慮湍流模擬方法與轉子軸向位置的磁懸浮血泵性能評估與優化設計研究. 蘇州: 蘇州大學, 2024.
12. Wu P, Huo J, Dai W, et al. On the optimization of a centrifugal maglev blood pump through design variations. Front Physiol, 2021, 12: 699891.
13. Blum C, Landoll M, Strassmann S E, et al. Blood trauma in veno-venous extracorporeal membrane oxygenation: low pump pressures and low circuit resistance matter. Crit Care, 2024, 28(1): 330.
14. Wu P, Huo J D, Zhang Z J, et al. The influence of non-conformal grid interfaces on the results of large eddy simulation of centrifugal blood pumps. Artif Organs, 2022, 46(9): 1804-1816.
15. Wu P, Gao Q, Hsu P L. On the representation of effective stress for computing hemolysis. Biomech Model Mechan, 2019, 18(3): 665-679.
16. Garon A, Farinas M I. Fast three‐dimensional numerical hemolysis approximation. Artif Organs, 2004, 28(11): 1016-1025.
17. Ding J, Niu S, Chen Z, et al. Shear-induced hemolysis: species differences. Artif Organs, 2015, 39(9): 795-802.
18. 葛婉寧, 梅旭, 張柳笛. 心室輔助裝置溶血測試中游離血紅蛋白檢測方法比較. 北京生物醫學工程, 2024, 43(5): 500-505.
19. Malinauskas R A, Hariharan P, Day S W, et al. FDA benchmark medical device flow models for CFD validation. ASAIO J, 2017, 63(2): 150-160.
20. Li P, Mei X, Ge W, et al. A comprehensive comparison of the in vitro hemocompatibility of extracorporeal centrifugal blood pumps. Front Physiol, 2023, 14: 1136545.

Journal of Biomedical Engineering

Design of a benchmark pump model and optimization of hemolysis testing protocol for evaluation of blood pump hemocompatibility

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