Numerical study on structural design and mechanical analysis of anti-migration tracheal stent with non-uniform Poisson’s ratio_Journal of Biomedical Engineering

Authors：

TAO Keyi ^1,2 , SUN Hao ^1,2 , LIU Zhao ^1,2 , DU Tianming ^1,2 , ZHANG Yanping ^1,2 , CHENG yuan ³ , HUANG Junfang ³ ,  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. Department of Respiratory and Critical Care medicine, Peking University First Hospital, Beijing 100034, P. R. China;

Corresponding?author：

QIAO Aike, Email: qak@bjut.edu.cn

Keywords：

Tracheal stent; Stent migration; Negative Poisson's ratio; Numerical simulation; Biomechanics

DOI：

10.7507/1001-5515.202402014

Video：

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Stent migration is one of the common complications after tracheal stent implantation. The causes of stent migration include size mismatch between the stent and the trachea, physiological movement of the trachea, and so on. In order to solve the above problems, this study designed a non-uniform Poisson ratio tracheal stent by combining the size and structure of the trachea and the physiological movement of the trachea to improve the migration of the stent, meanwhile ensuring the support of the stent. In this study, the stent corresponding to cartilage was constructed with negative Poisson's ratio, and the stent corresponding to the circular connective tissue and muscular membrane was constructed with positive Poisson's ratio. And four kinds of non-uniform Poisson's ratio tracheal stents with different link lengths and negative Poisson's ratio were designed. Then, this paper numerically simulated the expansion and rebound process of the stent after implantation to observe the support of the stent, and further simulated the stretch movement of the trachea to calculate the diameter changes of the stent corresponding to different negative Poisson's ratio structures. The axial migration of the stent was recorded by applying different respiratory pressure to the wall of the tracheal wall to evaluate whether the stent has anti-migration effect. The research results show that the non-uniform Poisson ratio stent with connecting rod length of 3 mm has the largest diameter expansion in the negative Poisson ratio section when the trachea was stretched. Compared with the positive Poisson's ratio structure, the axial migration during vigorous breathing was reduced from 0.024 mm to 0.012 mm. The negative Poisson's ratio structure of the non-uniform Poisson's ratio stent designed in this study did not fail in the tracheal expansion effect. Compared with the traditional stent, the non-uniform Poisson's ratio tracheal stent has an anti-migration effect under the normal movement of the trachea while ensuring the support force of the stent.

Citation： TAO Keyi, SUN Hao, LIU Zhao, DU Tianming, ZHANG Yanping, CHENG yuan, HUANG Junfang, QIAO Aike. Numerical study on structural design and mechanical analysis of anti-migration tracheal stent with non-uniform Poisson’s ratio. Journal of Biomedical Engineering, 2024, 41(5): 1035-1045. doi: 10.7507/1001-5515.202402014 Copy

1.	Saito Y, Imamura H. Airway stenting. Surgery Today, 2005, 35(4): 265-270.
2.	Malvè M, del Palomar A P, López-Villalobos J L, et al. FSI analysis of the coughing mechanism in a human trachea. Annals of Biomedical Engineering, 2010, 38(4): 1556-1565.
3.	王洪武, 金發光, 張楠. 氣道內金屬支架臨床應用中國專家共識. 中華肺部疾病雜志(電子版), 2021, 14(1): 5-10.
4.	Bolliger C T, Heitz M, Hauser R, et al. An airway wallstent for the treatment of tracheobronchial malignancies. Thorax, 1996, 51: 1127-1129.
5.	Gellasch K L, Dá Costa Gómez T, McAnulty J F, et al. Use of intraluminal nitinol stents in the treatment of tracheal collapse in a dog. Journal of the American Veterinary Medical Association, 2002, 221(12): 1719-1723.
6.	Kim D H, Choi C B, Chung W H, et al. Preliminary study for a newly designed silicone stent and delivery system for canine obstructive tracheal disease. Journal of Veterinary Medical Science, 2012, 74(10): 1323-1326.
7.	羅鈺坤, 劉新, 高李玉, 等. 電子支氣管鏡引導下支架置入術治療惡性氣道狹窄對血氣指標氣促癥狀及肺功能的影響. 河北醫學, 2023, 29(9): 1554-1558.
8.	Liu J, Yao X, Wang Z, et al. A flexible porous chiral auxetic tracheal stent with ciliated epithelium. Acta Biomaterialia, 2021, 124: 153-165.
9.	Liu J, Yao X, Wang Z, et al. A novel wavy non-uniform ligament chiral stent with J-shaped stress- strain behavior to mimic the native trachea. Bio-Design and Manufacturing, 2021, 4(4): 851-866.
10.	Fiorentino A, Piazza C, Ceretti E. Anti-migration enhanced tracheal stent design, rapid manufacturing and experimental tests. Rapid Prototyping Journal, 2016, 22(1): 178-188.
11.	Piazza C, Vang C, Lindgren E, et al. Low profile airway stent//2019 Design of Medical Devices Conference, Minneapolis: ASME, 2019: 3233.
12.	楊新月, 馬顏雪, 徐宸, 等. “啞鈴”形人工氣管支架的設計、制備與性能研究. 產業用紡織品, 2023, 41(5): 25-32.
13.	Jung H S, Chae G, Kim J H, et al. The mechanical characteristics and performance evaluation of a newly developed silicone airway stent (GINA stent). Scientific Reports, 2021, 11(1): 7958.
14.	Ratnovsky A, Regev N, Wald S, et al. Mechanical properties of different airway stents. Medical Engineering & Physics, 2015, 37(4): 408-415.
15.	Wu Z, Zhao J, Wu W, et al. Radial compressive property and the proof-of-concept study for realizing self-expansion of 3D printing polylactic acid vascular stents with negative Poisson’s ratio structure. Materials, 2018, 11(8): 1357.
16.	Han Y, Lu W. Optimizing the deformation behavior of stent with nonuniform Poisson's ratio distribution for curved artery. Journal of the Mechanical Behavior of Biomedical Materials, 2018, 88: 442-452.
17.	Lee J W, Soman P, Park J H, et al. A tubular biomaterial construct exhibiting a negative Poisson’s ratio. Plos One, 2016, 11(5): e0155681.
18.	Han Y, Lu W. Evolutionary design of nonuniform cellular structures with optimized Poisson's ratio distribution. Materials & Design, 2018, 141: 384-394.
19.	Boazak E M, Auguste D T. Trachea mechanics for tissue engineering design. Acs Biomaterials Science & Engineering, 2018, 4(4): 1272-1284.
20.	Wailoo M P, Emery J L. Normal growth and development of the trachea. Thorax, 1982, 37(8): 584-587.
21.	Serrano-Casorran C, Lopez-Minguez S, Rodriguez-Zapater S, et al. A new airway spiral stent designed to maintain airway architecture with an atraumatic removal after full epithelization-research of feasibility and viability in canine patients with tracheomalacia. Pediatr Pulmonol, 2020, 55(7): 1757-1764.
22.	喬愛科, 陶克怡, 陳詩亮, 等. 一種氣管支架: 中國, CN117462299A, 2024-01-30.
23.	Chaure J , Serrano C ,Fernández-Parra, R,et al. On studying the interaction between different stent models and rabbit tracheal tissue: numerical, endoscopic and histological comparison. Annals of Biomedical Engineering, 2016, 44(2): 368-381.
24.	Mortier P, Holzapfel G A, De Beule M, et al. A novel simulation strategy for stent insertion and deployment in curved coronary bifurcations: comparison of three drug-eluting stents. Annals of Biomedical Engineering, 2010, 38(1): 88-99.
25.	柳思聰, 張晗冰, 李曉, 等. 狹窄血管內適形貼壁支架的結構設計及生物力學性能的數值分析. 生物醫學工程學雜志, 2021, 38(5): 858-868.
26.	Zhu Z, Li X, Xu J. Study on loss mechanism of SMA tracheal stent subjected to cough excitation. Biomedical Materials & Engineering, 2015, 26(Suppl 1): S547-S553.
27.	Bao Y D, Qu S Q, Wei W, et al. Investigation on forced vibration characteristics of Nitinol tracheal stent. Biomed Eng Online, 2022, 21(1): 85.
28.	李夢偉, 亢玉, 寇宇晴, 等. 基于可穿戴設備量化分析急性心衰患者夜間呼吸模式的探索性研究. 生物醫學工程學雜志, 2023, 40(6): 1108-1116.
29.	劉宇星, 艾遼元, 毛琳, 等. 冠脈支架與血管耦合作用的有限元分析. 北京生物醫學工程, 2019, 38(4): 331-338.
30.	崔新陽. 一種可降解鋅合金血管支架支撐性能及疲勞力學的研究. 北京: 北京工業大學, 2019.
31.	Ryu Y J, Kim H, Yu C M, et al. Comparison of natural and Dumon airway stents for the management of benign tracheobronchial stenoses. Respirology, 2006, 11(6): 748-754.
32.	Malvè M, Barreras I, López-Villalobos J L, et al. Computational fluid-dynamics optimization of a human tracheal endoprosthesis. International Communications in Heat and Mass Transfer, 2012, 39(5): 575-581.
33.	Trabelsi O, Palomar A P D, Tobar A M, et al. FE simulation of human trachea swallowing movement before and after the implantation of an endoprothesis. Applied Mathematical Modelling, 2011, 35(10): 4902-4912.
34.	Freitag L, Tekolf E, Stamatis G, et al. Clinical evaluation of a new bifurcated dynamic airway stent: a 5-year experience with 135 patients. Thorac Cardiovasc Surg, 1997, 45(1): 6-12.
35.	Freitag L, Eicker R, Linz B, et al. Theoretical and experimental basis for the development of a dynamic airway stent. European Respiratory Journal, 1994, 7(11): 2038-2045.
36.	Wang T, Zhu Z. Dynamic response and tirst passage of SMA tracheal stent in cough process. Journal of Mechanics in Medicine and Biology, 2020, 20(9): 2040019.

1. Saito Y, Imamura H. Airway stenting. Surgery Today, 2005, 35(4): 265-270.
2. Malvè M, del Palomar A P, López-Villalobos J L, et al. FSI analysis of the coughing mechanism in a human trachea. Annals of Biomedical Engineering, 2010, 38(4): 1556-1565.
3. 王洪武, 金發光, 張楠. 氣道內金屬支架臨床應用中國專家共識. 中華肺部疾病雜志(電子版), 2021, 14(1): 5-10.
4. Bolliger C T, Heitz M, Hauser R, et al. An airway wallstent for the treatment of tracheobronchial malignancies. Thorax, 1996, 51: 1127-1129.
5. Gellasch K L, Dá Costa Gómez T, McAnulty J F, et al. Use of intraluminal nitinol stents in the treatment of tracheal collapse in a dog. Journal of the American Veterinary Medical Association, 2002, 221(12): 1719-1723.
6. Kim D H, Choi C B, Chung W H, et al. Preliminary study for a newly designed silicone stent and delivery system for canine obstructive tracheal disease. Journal of Veterinary Medical Science, 2012, 74(10): 1323-1326.
7. 羅鈺坤, 劉新, 高李玉, 等. 電子支氣管鏡引導下支架置入術治療惡性氣道狹窄對血氣指標氣促癥狀及肺功能的影響. 河北醫學, 2023, 29(9): 1554-1558.
8. Liu J, Yao X, Wang Z, et al. A flexible porous chiral auxetic tracheal stent with ciliated epithelium. Acta Biomaterialia, 2021, 124: 153-165.
9. Liu J, Yao X, Wang Z, et al. A novel wavy non-uniform ligament chiral stent with J-shaped stress- strain behavior to mimic the native trachea. Bio-Design and Manufacturing, 2021, 4(4): 851-866.
10. Fiorentino A, Piazza C, Ceretti E. Anti-migration enhanced tracheal stent design, rapid manufacturing and experimental tests. Rapid Prototyping Journal, 2016, 22(1): 178-188.
11. Piazza C, Vang C, Lindgren E, et al. Low profile airway stent//2019 Design of Medical Devices Conference, Minneapolis: ASME, 2019: 3233.
12. 楊新月, 馬顏雪, 徐宸, 等. “啞鈴”形人工氣管支架的設計、制備與性能研究. 產業用紡織品, 2023, 41(5): 25-32.
13. Jung H S, Chae G, Kim J H, et al. The mechanical characteristics and performance evaluation of a newly developed silicone airway stent (GINA stent). Scientific Reports, 2021, 11(1): 7958.
14. Ratnovsky A, Regev N, Wald S, et al. Mechanical properties of different airway stents. Medical Engineering & Physics, 2015, 37(4): 408-415.
15. Wu Z, Zhao J, Wu W, et al. Radial compressive property and the proof-of-concept study for realizing self-expansion of 3D printing polylactic acid vascular stents with negative Poisson’s ratio structure. Materials, 2018, 11(8): 1357.
16. Han Y, Lu W. Optimizing the deformation behavior of stent with nonuniform Poisson's ratio distribution for curved artery. Journal of the Mechanical Behavior of Biomedical Materials, 2018, 88: 442-452.
17. Lee J W, Soman P, Park J H, et al. A tubular biomaterial construct exhibiting a negative Poisson’s ratio. Plos One, 2016, 11(5): e0155681.
18. Han Y, Lu W. Evolutionary design of nonuniform cellular structures with optimized Poisson's ratio distribution. Materials & Design, 2018, 141: 384-394.
19. Boazak E M, Auguste D T. Trachea mechanics for tissue engineering design. Acs Biomaterials Science & Engineering, 2018, 4(4): 1272-1284.
20. Wailoo M P, Emery J L. Normal growth and development of the trachea. Thorax, 1982, 37(8): 584-587.
21. Serrano-Casorran C, Lopez-Minguez S, Rodriguez-Zapater S, et al. A new airway spiral stent designed to maintain airway architecture with an atraumatic removal after full epithelization-research of feasibility and viability in canine patients with tracheomalacia. Pediatr Pulmonol, 2020, 55(7): 1757-1764.
22. 喬愛科, 陶克怡, 陳詩亮, 等. 一種氣管支架: 中國, CN117462299A, 2024-01-30.
23. Chaure J , Serrano C ,Fernández-Parra, R,et al. On studying the interaction between different stent models and rabbit tracheal tissue: numerical, endoscopic and histological comparison. Annals of Biomedical Engineering, 2016, 44(2): 368-381.
24. Mortier P, Holzapfel G A, De Beule M, et al. A novel simulation strategy for stent insertion and deployment in curved coronary bifurcations: comparison of three drug-eluting stents. Annals of Biomedical Engineering, 2010, 38(1): 88-99.
25. 柳思聰, 張晗冰, 李曉, 等. 狹窄血管內適形貼壁支架的結構設計及生物力學性能的數值分析. 生物醫學工程學雜志, 2021, 38(5): 858-868.
26. Zhu Z, Li X, Xu J. Study on loss mechanism of SMA tracheal stent subjected to cough excitation. Biomedical Materials & Engineering, 2015, 26(Suppl 1): S547-S553.
27. Bao Y D, Qu S Q, Wei W, et al. Investigation on forced vibration characteristics of Nitinol tracheal stent. Biomed Eng Online, 2022, 21(1): 85.
28. 李夢偉, 亢玉, 寇宇晴, 等. 基于可穿戴設備量化分析急性心衰患者夜間呼吸模式的探索性研究. 生物醫學工程學雜志, 2023, 40(6): 1108-1116.
29. 劉宇星, 艾遼元, 毛琳, 等. 冠脈支架與血管耦合作用的有限元分析. 北京生物醫學工程, 2019, 38(4): 331-338.
30. 崔新陽. 一種可降解鋅合金血管支架支撐性能及疲勞力學的研究. 北京: 北京工業大學, 2019.
31. Ryu Y J, Kim H, Yu C M, et al. Comparison of natural and Dumon airway stents for the management of benign tracheobronchial stenoses. Respirology, 2006, 11(6): 748-754.
32. Malvè M, Barreras I, López-Villalobos J L, et al. Computational fluid-dynamics optimization of a human tracheal endoprosthesis. International Communications in Heat and Mass Transfer, 2012, 39(5): 575-581.
33. Trabelsi O, Palomar A P D, Tobar A M, et al. FE simulation of human trachea swallowing movement before and after the implantation of an endoprothesis. Applied Mathematical Modelling, 2011, 35(10): 4902-4912.
34. Freitag L, Tekolf E, Stamatis G, et al. Clinical evaluation of a new bifurcated dynamic airway stent: a 5-year experience with 135 patients. Thorac Cardiovasc Surg, 1997, 45(1): 6-12.
35. Freitag L, Eicker R, Linz B, et al. Theoretical and experimental basis for the development of a dynamic airway stent. European Respiratory Journal, 1994, 7(11): 2038-2045.
36. Wang T, Zhu Z. Dynamic response and tirst passage of SMA tracheal stent in cough process. Journal of Mechanics in Medicine and Biology, 2020, 20(9): 2040019.

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