Structural design and mechanical analysis of a "drum-shaped" balloon-expandable valve stent in expanded configuration_Journal of Biomedical Engineering

Authors：

ZHAO Youzhi ^1,2 ,  HOU Qianwen ³ , ZHOU Jianye ³ , CHEN Shiliang ^1,2 , ZHANG Hanbing ^1,2 ,  QIAO Aike ^1,2

1. Department of Biomedical Engineering, College of Chemistry and Life Sciences, Beijing University of Technology, Beijing 100124, P. R. China;
2. Intelligent Physiological Measurement and Clinical Translation, Beijing International Base for Scientific and Technological Cooperation, Beijing 100124, P. R. China;
3. State Key Laboratory of Cardiovascular Disease, National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100037, P. R. China;

Corresponding author：

HOU Qianwen, Email: hqw@fuwaihospital.org; QIAO Aike, Email: qak@bjut.edu.cn

Keywords：

Aortic stenosis; Balloon-expandable valve stent; Structural design; Mechanical performance; Numerical simulation

DOI：

10.7507/1001-5515.202505020

Video：

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Abstract Full text Figures/Tables Video References Cited by

Stent migration is one of the common complications following transcatheter valve implantation. This study aims to design a “drum-shaped” balloon-expandable aortic valve stent to address this issue and conduct a mechanical analysis. The implantation process of the stent was evaluated using a method that combines numerical simulation and in vitro experiments. Furthermore, the fatigue process of the stent under pulsatile cyclic loading was simulated, and its fatigue performance was assessed using a Goodman diagram. The process of the stent migrating toward the left ventricular side was simulated, and the force-displacement curve of the stent was extracted to evaluate its anti- migration performance. The results showed that all five stent models could be crimped into a 14F sheath and enabled uniform expansion of the native valve leaflets. The stress in each stent was below the ultimate stress, so no fatigue fracture occurred. As the cell height ratio decreased, the contact area fraction between the stent and the aortic root gradually decreased. However, the mean contact force and the maximum anti-migration force first decreased and then increased. Specifically, model S5 had the smallest contact area fraction but the largest mean contact force and maximum anti-migration force, reaching approximately 0.16 MPa and 10.73 N, respectively. The designed stent achieves a “drum-shaped” change after expansion and has good anti-migration performance.

1.	申祥, 孙鹏, 鲁凯凯, 等. 球扩式介入主动脉瓣膜支架的抗迁移力学行为. 医用生物力学, 2023, 38(6): 1205-1210.
2.	Dong M, Wang L, Tse G, et al. Effectiveness and safety of transcatheter aortic valve replacement in elderly people with severe aortic stenosis with different types of heart failure. BMC Cardiovasc Disord, 2023, 23(1): 34.
3.	Dwyer H A, Matthews P B, Azadani A, et al. Migration forces of transcatheter aortic valves in patients with noncalcific aortic insufficiency. J Thorac Cardiovasc Surg, 2009, 138(5): 1227-1233.
4.	金屏, 翟蒙恩, 周国磊, 等. 国产球囊扩张介入瓣膜系统在经导管主动脉瓣置换术中的临床应用经验. 中国体外循环杂志, 2022, 20(2): 92-96.
5.	梁影, 管玉龙. 经导管主动脉瓣置换术研究现状及进展. 北京生物医学工程, 2018, 37(5): 533-538.
6.	Wang B, Mei Z, Ge X, et al. Comparison of outcomes of self-expanding versus balloon-expandable valves for transcatheter aortic valve replacement: a meta-analysis of randomized and propensity-matched studies. BMC Cardiovasc Disord, 2023, 23(1): 382.
7.	谭桐, 吴宏祥, 付冰奇, 等. 国产Renatus球囊扩张式介入瓣膜治疗重度主动脉瓣狭窄早期临床疗效的前瞻性队列研究. 中国胸心血管外科临床杂志, 2023, 30(2): 214-220.
8.	Kumar G P, Leo H L, Cui F. Design and evaluation of the crimping of a hooked self-expandable caval valve stent for the treatment of tricuspid regurgitation. Comput Methods Biomech Biomed Eng, 2019, 22(5): 533-546.
9.	孔祥权, 高晓飞, 张娟, 等. 经导管主动脉瓣置换术相关新瓣膜的研究进展. 华西医学, 2023, 38(9): 1309-1313.
10.	Mach M, Okutucu S, Kerbel T, et al. Vascular complications in TAVR: incidence, clinical impact, and management. J Clin Med, 2021, 10(21): 5046.
11.	Lavon K, Marom G, Bianchi M, et al. Biomechanical modeling of transcatheter aortic valve replacement in a stenotic bicuspid aortic valve: deployments and paravalvular leakage. Med Biol Eng Comput, 2019, 57(10): 2129-2143.
12.	Hou Q, Liu G, Liu N, et al. Effect of valve height on the opening and closing performance of the aortic valve under aortic root dilatation. Front Physiol, 2021, 12: 697502.
13.	De Beule M, Mortier P, Carlier S G, et al. Realistic finite element-based stent design: the impact of balloon folding. J Biomech, 2008, 41(2): 383-389.
14.	陶克怡, 孙浩, 刘昭, 等. 非均匀泊松比防移位气管支架的结构设计及力学分析的数值研究. 生物医学工程学杂志, 2024, 41(05): 1035-1045.
15.	Venezuela J, Dargusch M S. The influence of alloying and fabrication techniques on the mechanical properties, biodegradability and biocompatibility of zinc: a comprehensive review. Acta Biomater, 2019, 87: 1-40.
16.	王炎. 瓣膜支架在二叶式主动脉瓣中的疲劳力学行为与优化设计研究. 镇江: 江苏大学, 2023.
17.	Nappi F, Mazzocchi L, Spadaccio C, et al. CoreValve vs. Sapien 3 transcatheter aortic valve replacement: a finite element analysis study. Bioengineering-Basel, 2021, 8(5): 52.
18.	Qi J, Zhang H, Chen S, et al. Numerical simulation of dynamic degradation and fatigue damage of degradable zinc alloy stents. J Funct Biomater, 2023, 14(11): 547.
19.	Yoon H Y, Choi J Y. Fatigue analysis of canine tracheal stents using the finite element method. Vet Anim Sci, 2024, 23: 100341.
20.	Liu X, Zhang W, Ye P, et al. Mechanical and hydrodynamic effects of stent expansion in tapered coronary vessels. Biomech Model Mechanobiol, 2022, 21(5): 1549-1560.
21.	Mutlu O, Mazhar N, Saribay M, et al. Finite element analysis of evolut transcatheter heart valves: effects of aortic geometries and valve sizes on Post-TAVI wall stresses and deformations. J Clin Med, 2025, 14(3): 850.
22.	孙浩, 陶克怡, 刘昭, 等. 适形贴壁支架的“适形”与“可行”结构设计及其力学分析. 生物医学工程学杂志, 2024, 41(4): 790-797.
23.	Almeida J G, Ferreira S M, Fonseca P, et al. Association between implantation depth assessed by computed tomography and new-onset conduction disturbances after transcatheter aortic valve implantation. J Cardiovasc Comput Tomogr, 2017, 11(5): 332-337.
24.	Van der Boon R M A, Houthuizen P, Urena M, et al. Trends in the occurrence of new conduction abnormalities after transcatheter aortic valve implantation. Catheter Cardio Inte, 2015, 85(5): 144-152.
25.	Finotello A, Romarowski R M, Gorla R, et al. Performance of high conformability vs. high radial force devices in the virtual treatment of TAVI patients with bicuspid aortic valve. Med Eng Phys, 2021, 89: 42-50.
26.	石更强, 潘肖林, 李元, 等. 球囊扩张式支架扩张过程的数值模拟. 北京生物医学工程, 2018, 37(3): 241-245.
27.	张站柱, 乔爱科, 付文宇. 不同连接筋结构的支架治疗椎动脉狭窄的血流动力学数值模拟. 医用生物力学, 2013, 28(2): 148-153.
28.	Ho K, Hung M, Chen J, et al. Design and testing of a new vascular stent with enhanced fatigue life. IOP Conf Ser Mater Sci Eng, 2019, 644: 012015.
29.	Baylous K, Helbock R, Kovarovic B, et al. In silico fatigue optimization of TAVR stent designs with physiological motion in a beating heart model. Comput Methods Programs Biomed, 2024, 243: 107886.
30.	陈奕文, 黄秀玲, 董双鹏, 等. 血管支架疲劳性能的体外测试方法现状. 北京生物医学工程, 2024, 43(5): 525-530.
31.	McGee O M, Sun W, McNamara L M. An in vitro model quantifying the effect of calcification on the tissue-stent interaction in a stenosed aortic root. J Biomech, 2019, 82: 109-115.
32.	Sturla F, Ronzoni M, Vitali M, et al. Impact of different aortic valve calcification patterns on the outcome of transcatheter aortic valve implantation: a finite element study. J Biomech, 2016, 49(12): 2520-2530.
33.	Wang Q, Kodali S, Primiano C, et al. Simulations of transcatheter aortic valve implantation: implications for aortic root rupture. Biomech Model Mechanobiol, 2015, 14(1): 29-38.
34.	Qiu D, Barakat M, Hopkins B, et al. Transcatheter aortic valve replacement in bicuspid valves: the synergistic effects of eccentric and incomplete stent deployment. J Mech Behav Biomed Mater, 2021, 121: 104621.
35.	Russ C, Hopf R, Hirsch S, et al. Simulation of transcatheter aortic valve implantation under consideration of leaflet calcification// 35th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC). Osaka: IEEE, 2013: 711-714.
36.	Wang Q, Sirois E, Sun W. Patient-specific modeling of biomechanical interaction in transcatheter aortic valve deployment. J Biomech, 2012, 45(11): 1965-1971.

1. 申祥, 孙鹏, 鲁凯凯, 等. 球扩式介入主动脉瓣膜支架的抗迁移力学行为. 医用生物力学, 2023, 38(6): 1205-1210.
2. Dong M, Wang L, Tse G, et al. Effectiveness and safety of transcatheter aortic valve replacement in elderly people with severe aortic stenosis with different types of heart failure. BMC Cardiovasc Disord, 2023, 23(1): 34.
3. Dwyer H A, Matthews P B, Azadani A, et al. Migration forces of transcatheter aortic valves in patients with noncalcific aortic insufficiency. J Thorac Cardiovasc Surg, 2009, 138(5): 1227-1233.
4. 金屏, 翟蒙恩, 周国磊, 等. 国产球囊扩张介入瓣膜系统在经导管主动脉瓣置换术中的临床应用经验. 中国体外循环杂志, 2022, 20(2): 92-96.
5. 梁影, 管玉龙. 经导管主动脉瓣置换术研究现状及进展. 北京生物医学工程, 2018, 37(5): 533-538.
6. Wang B, Mei Z, Ge X, et al. Comparison of outcomes of self-expanding versus balloon-expandable valves for transcatheter aortic valve replacement: a meta-analysis of randomized and propensity-matched studies. BMC Cardiovasc Disord, 2023, 23(1): 382.
7. 谭桐, 吴宏祥, 付冰奇, 等. 国产Renatus球囊扩张式介入瓣膜治疗重度主动脉瓣狭窄早期临床疗效的前瞻性队列研究. 中国胸心血管外科临床杂志, 2023, 30(2): 214-220.
8. Kumar G P, Leo H L, Cui F. Design and evaluation of the crimping of a hooked self-expandable caval valve stent for the treatment of tricuspid regurgitation. Comput Methods Biomech Biomed Eng, 2019, 22(5): 533-546.
9. 孔祥权, 高晓飞, 张娟, 等. 经导管主动脉瓣置换术相关新瓣膜的研究进展. 华西医学, 2023, 38(9): 1309-1313.
10. Mach M, Okutucu S, Kerbel T, et al. Vascular complications in TAVR: incidence, clinical impact, and management. J Clin Med, 2021, 10(21): 5046.
11. Lavon K, Marom G, Bianchi M, et al. Biomechanical modeling of transcatheter aortic valve replacement in a stenotic bicuspid aortic valve: deployments and paravalvular leakage. Med Biol Eng Comput, 2019, 57(10): 2129-2143.
12. Hou Q, Liu G, Liu N, et al. Effect of valve height on the opening and closing performance of the aortic valve under aortic root dilatation. Front Physiol, 2021, 12: 697502.
13. De Beule M, Mortier P, Carlier S G, et al. Realistic finite element-based stent design: the impact of balloon folding. J Biomech, 2008, 41(2): 383-389.
14. 陶克怡, 孙浩, 刘昭, 等. 非均匀泊松比防移位气管支架的结构设计及力学分析的数值研究. 生物医学工程学杂志, 2024, 41(05): 1035-1045.
15. Venezuela J, Dargusch M S. The influence of alloying and fabrication techniques on the mechanical properties, biodegradability and biocompatibility of zinc: a comprehensive review. Acta Biomater, 2019, 87: 1-40.
16. 王炎. 瓣膜支架在二叶式主动脉瓣中的疲劳力学行为与优化设计研究. 镇江: 江苏大学, 2023.
17. Nappi F, Mazzocchi L, Spadaccio C, et al. CoreValve vs. Sapien 3 transcatheter aortic valve replacement: a finite element analysis study. Bioengineering-Basel, 2021, 8(5): 52.
18. Qi J, Zhang H, Chen S, et al. Numerical simulation of dynamic degradation and fatigue damage of degradable zinc alloy stents. J Funct Biomater, 2023, 14(11): 547.
19. Yoon H Y, Choi J Y. Fatigue analysis of canine tracheal stents using the finite element method. Vet Anim Sci, 2024, 23: 100341.
20. Liu X, Zhang W, Ye P, et al. Mechanical and hydrodynamic effects of stent expansion in tapered coronary vessels. Biomech Model Mechanobiol, 2022, 21(5): 1549-1560.
21. Mutlu O, Mazhar N, Saribay M, et al. Finite element analysis of evolut transcatheter heart valves: effects of aortic geometries and valve sizes on Post-TAVI wall stresses and deformations. J Clin Med, 2025, 14(3): 850.
22. 孙浩, 陶克怡, 刘昭, 等. 适形贴壁支架的“适形”与“可行”结构设计及其力学分析. 生物医学工程学杂志, 2024, 41(4): 790-797.
23. Almeida J G, Ferreira S M, Fonseca P, et al. Association between implantation depth assessed by computed tomography and new-onset conduction disturbances after transcatheter aortic valve implantation. J Cardiovasc Comput Tomogr, 2017, 11(5): 332-337.
24. Van der Boon R M A, Houthuizen P, Urena M, et al. Trends in the occurrence of new conduction abnormalities after transcatheter aortic valve implantation. Catheter Cardio Inte, 2015, 85(5): 144-152.
25. Finotello A, Romarowski R M, Gorla R, et al. Performance of high conformability vs. high radial force devices in the virtual treatment of TAVI patients with bicuspid aortic valve. Med Eng Phys, 2021, 89: 42-50.
26. 石更强, 潘肖林, 李元, 等. 球囊扩张式支架扩张过程的数值模拟. 北京生物医学工程, 2018, 37(3): 241-245.
27. 张站柱, 乔爱科, 付文宇. 不同连接筋结构的支架治疗椎动脉狭窄的血流动力学数值模拟. 医用生物力学, 2013, 28(2): 148-153.
28. Ho K, Hung M, Chen J, et al. Design and testing of a new vascular stent with enhanced fatigue life. IOP Conf Ser Mater Sci Eng, 2019, 644: 012015.
29. Baylous K, Helbock R, Kovarovic B, et al. In silico fatigue optimization of TAVR stent designs with physiological motion in a beating heart model. Comput Methods Programs Biomed, 2024, 243: 107886.
30. 陈奕文, 黄秀玲, 董双鹏, 等. 血管支架疲劳性能的体外测试方法现状. 北京生物医学工程, 2024, 43(5): 525-530.
31. McGee O M, Sun W, McNamara L M. An in vitro model quantifying the effect of calcification on the tissue-stent interaction in a stenosed aortic root. J Biomech, 2019, 82: 109-115.
32. Sturla F, Ronzoni M, Vitali M, et al. Impact of different aortic valve calcification patterns on the outcome of transcatheter aortic valve implantation: a finite element study. J Biomech, 2016, 49(12): 2520-2530.
33. Wang Q, Kodali S, Primiano C, et al. Simulations of transcatheter aortic valve implantation: implications for aortic root rupture. Biomech Model Mechanobiol, 2015, 14(1): 29-38.
34. Qiu D, Barakat M, Hopkins B, et al. Transcatheter aortic valve replacement in bicuspid valves: the synergistic effects of eccentric and incomplete stent deployment. J Mech Behav Biomed Mater, 2021, 121: 104621.
35. Russ C, Hopf R, Hirsch S, et al. Simulation of transcatheter aortic valve implantation under consideration of leaflet calcification// 35th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC). Osaka: IEEE, 2013: 711-714.
36. Wang Q, Sirois E, Sun W. Patient-specific modeling of biomechanical interaction in transcatheter aortic valve deployment. J Biomech, 2012, 45(11): 1965-1971.

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Latest ArticlesStructural design and mechanical analysis of a "drum-shaped" balloon-expandable valve stent in expanded configuration

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