AccScience Publishing / IJB / Volume 8 / Issue 2 / DOI: 10.18063/ijb.v8i2.549
RESEARCH ARTICLE

3D-Printing-Assisted Extraluminal Anti-Reflux Diodes for Preventing Vesicoureteral Reflux through Double-J Stents

Jihun Lee1 Jaebum Sung1 Jung Ki Jo2* Hongyun So1,3*
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1 Department of Mechanical Engineering, Hanyang University, Seoul 04763, South Korea
2 Department of Urology, College of Medicine, Hanyang University, Seoul 04763, South Korea
3 Institute of Nano Science and Technology, Hanyang University, Seoul 04763, South Korea
Submitted: 21 December 2021 | Accepted: 7 February 2022 | Published: 7 February 2022
© 2022 by the Author(s). This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution 4.0 International License ( https://creativecommons.org/licenses/by/4.0/ )
Abstract

This paper presents novel umbrella-shaped flexible devices to prevent vesicoureteral reflux along double-J stents, which is a backward flow of urine from the bladder to the kidney and is a critical issue in patients with urinary stones. The anti-reflux devices were designed to mechanically attach to the stent and were manufactured using three-dimensional (3D) printing and polymer casting methods. Based on the umbrella shapes, four different devices were manufactured, and the antireflux efficiency was demonstrated through in vitro experiments using a urination model. Consequently, penta-shaped devices exhibited the best anti-reflux performance (44% decrease in reflux compared to the stent without the device), and maximum efficiency occurred when the device was attached near the bladder-ureter junction. In addition, a disadvantage of 3D printing (i.e., unwanted rough surface) helped the device strongly adhere to the surface of the stent during the insertion operation. Finally, long-term soaking experiments revealed that the fabricated devices were mechanically robust and chemically stable (safe) even being soaked in urine for 4 weeks. The findings of this study support the use of additive manufacturing to make various flexible and biocompatible urological devices to mitigate critical issues in patients with urinary stones.

Keywords
Vesicoureteral reflux
Double-J stent
3D printing
Anti-reflux diode
Urology
References

1. Pengfei S, Min J, Jie Y, et al., 2011, Use of Ureteral Stent in Extracorporeal Shock Wave Lithotripsy for Upper Urinary Calculi: A Systematic Review and Meta-analysis. J Urol, 186:1328–35. https://doi.org/10.1016/j.juro.2011.05.073

2. Hübner WA, Plas EG, Trigo-Rocha F, et al., 1993, Drainage and Reflux Characteristics of Antireflux Ureteral Double-J Stents. J Endourol, 7:497–9. https://doi.org/10.1089/end.1993.7.497

3. Dyer RB, Chen MY, Zagoria RJ, et al., 2002, Complications of Ureteral Stent Placement. Radiographics, 22:1005–22. https://doi.org/10.1148/radiographics.22.5.g02se081005

4. Irani J, Siquier J, Pirès C, et al., 1999, Symptom Characteristics and the Development of Tolerance with Time in Patients with Indwelling Double-pigtail Ureteric Stents. BJU Int, 84:276–9. https://doi.org/10.1046/j.1464-410x.1999.00154.x

5. Auge BK, Preminger GM, 2002, Ureteral stents and their use in endourology. Curr Opin Urol, 12:217–22. https://doi.org/10.1097/00042307-200205000-00007

6. Sarier M, Demir M, Duman I, et al., 2017, Evaluation of Ureteral Stent Colonization in Live-Donor Renal Transplant Recipients. Transplant Proc, 49:415–9. https://doi.org/10.1016/j.transproceed.2017.01.004

7. Sarier M, Seyman D, Tekin S, et al., 2017, Comparision of Ureteral Stent Colonization Between Deceased and Live Donor Renal Transplant Recipients. Transplant Proc, 49:2082–5. https://doi.org/10.1016/j.transproceed.2017.09.028

8. Kim HH, Kim KW, Choi YH, et al., 2020, Numerical Analysis of Urine Flow with Multiple Sizes of Double-J Stents. Appl Sci, 10:4291. https://doi.org/10.3390/app10124291

9. Seymour H, Patel U, 2000, Ureteric Stenting-current Status. Semin Intervent Radiol, 17:351–65. https://doi.org/10.1055/s-2000-13148

10. Damiano R, Oliva A, Esposito C, et al., 2002, Early and Late Complications of Double Pigtail Ureteral Stent. Urol Int, 69:136–40. https://doi.org/10.1159/000065563

11. Leibovici D, Cooper A, Lindner A, et al., 2005, Ureteral Stents: Morbidity and Impact on Quality of Life. Isr Med Assoc J, 7:491–4.

12. Al-Marhoon MS, Shareef O, Venkiteswaran KP, 2012, Complications and Outcomes of JJ Stenting of the Ureter in Urological Practice: A Single-centre Experience. Arab J Urol, 10:372–7.  https://doi.org/10.1016/j.aju.2012.08.004

13. Joshi HB, Okeke A, Newns N, et al., 2002, Characterization of Urinary Symptoms in Patients with Ureteral Stents. Urology, 59:511–6. https://doi.org/10.1016/s0090-4295(01)01644-2

14. de la Cruz JE, Fernández I, Sanz-Migueláñez JL, et al., 2021, Assessment of the Grades of Vesicoureteral Reflux in Stented Ureters: An Experimental Study. Urol Int, 105:554–9. https://doi.org/10.1159/000515613

15. Ritter M, Krombach P, Knoll T, et al., 2012, Initial Experience with a Newly Developed Antirefluxive Ureter Stent. Urol Res, 40:349–53. https://doi.org/10.1007/s00240-011-0415-5

16. Cummings LJ, Waters SL, Wattis JAD, et al., 2004, The Effect of Ureteric Stents on Urine Flow: Reflux. J Math Biol, 49:56–82. https://doi.org/10.1007/s00285-003-0252-4.

17. Vahidi B, Fatouraee N, 2012, A Biomechanical Simulation of Ureteral Flow During Peristalsis using Intraluminal Morphometric Data. J Theor Biol, 298:42–50. https://doi.org/10.1016/j.jtbi.2011.12.019

18. Peters C, Rushton HG, 2010, Vesicoureteral Reflux Associated Renal Damage: Congenital Reflux Nephropathy and Acquired Renal Scarring. J Urol, 184:265–73. https://doi.org/10.1016/j.juro.2010.03.076

19. Chew BH, Lange D, 2016, Advances in Ureteral Stent Development. Curr Opin Urol, 26:277–82. https://doi.org/10.1097/MOU.0000000000000275

20. Chew BH, Seitz C, 2016, Impact of Ureteral Stenting in Ureteroscopy. Curr Opin Urol, 26:76–80. https://doi.org/10.1097/MOU.0000000000000234

21. Park CJ, Kim HW, Jeong S, et al., 2015, Anti-reflux Ureteral Stent with Polymeric Flap Valve using Three-dimensional Printing: An in vitro Study. J Endourol, 29:933–8. https://doi.org/10.1089/end.2015.0154

22. Korkes F, Baccaglini W, Silveira MA, 2019, Is Ureteral Stent an Effective Way to Deliver Drugs Such as Bacillus Calmette-Guérin to the Upper Urinary Tract? An experimental study, Ther Adv Urol, 11:1–7. https://doi.org/10.1177/1756287219836895

23. Yamaguchi O, Yoshimura Y, Irisawa C, et al., 1992, Prototype of a Reflux-preventing Ureteral Stent and its Clinical Use. Urology, 40:326–9. https://doi.org/10.1016/0090-4295(92)90381-6

24. Clavica F, Zhao X, ElMahdy M, et al., 2014, Investigating the Flow Dynamics in the Obstructed and Stented Ureter by Means of a Biomimetic Artificial Model. PLoS One, 9:e87433. https://doi.org/10.1371/journal.pone.0087433

25. Kim HW, Park CJ, Seo S, et al., 2016, Evaluation of a Polymeric Flap Valve-attached Ureteral Stent for Preventing Vesicoureteral Reflux in Elevated Intravesical Pressure Conditions: A Pilot Study Using a Porcine Model. J Endourol, 30:428–32. https://doi.org/10.1089/end.2015.0711

26. Liu Z, Liu N, Zhao C, et al., 2020, Preliminary Assessment of the Effectiveness of an Anti-reflux Ureteral Stent with a Novel Device in a Swine Model. Int J Clin Exp Med, 13:141–7.

27. Ecke TH, Bartel P, Hallmann S, et al., 2010, Evaluation of Symptoms and Patients’ Comfort for JJ-ureteral Stents With and Without Antireflux-membrane Valve. Urology, 75:212–6. https://doi.org/10.1016/j.urology.2009.07.1258

28. Urrios A, Parra-Cabrera C, Bhattacharjee N, et al., 2016, 3D-printing of Transparent Bio-microfluidic Devices in PEGDA. Lab Chip, 16:2287–94. https://doi.org/10.1039/c6lc00153j

29. Schweiger J, Beuer F, Stimmelmayr M, et al., 2016, Histoanatomic 3D Printing of Dental Structures. Br Dent J, 221:555–60. https://doi.org/10.1038/sj.bdj.2016.815

30. Jeong YG, Lee WS, Lee KB, 2018, Accuracy Evaluation of Dental Models Manufactured by CAD/CAM Milling Method and 3D Printing Method. J Adv Prosthodont, 10:245–51. https://doi.org/10.4047/jap.2018.10.3.245

31. Yoshikawa M, Sato R, Higashihara T, et al., 2015, Rehand: Realistic Electric Prosthetic Hand Created with a 3D Printer. Proc Annu Int Conf IEEE Eng Med Biol Soc, 2015:2470–3. https://doi.org/10.1109/EMBC.2015.7318894

32. Burn MB, Ta A, Gogola GR, 2016, Three-dimensional Printing of Prosthetic Hands for Children. J Hand Surg Am, 41:e103–9. https://doi.org/10.1016/j.jhsa.2016.02.008

33. Del Junco M, Okhunov Z, Yoon R, et al., 2015, Development and Initial Porcine and Cadaver Experience with Three dimensional Printing of Endoscopic and Laparoscopic Equipment. J Endourol, 29:58–62. https://doi.org/10.1089/end.2014.0280

34. He Y, Xue GH, Fu JZ, 2014, Fabrication of Low Cost Soft Tissue Prostheses with the Desktop 3D Printer. Sci Rep, 4:1–7. https://doi.org/10.1038/srep06973

35. Bégin-Drolet A, Dussault MA, Fernandez SA, et al., 2017, Design of a 3D Printer Head for Additive Manufacturing of Sugar Glass for Tissue Engineering Applications. Addit Manuf, 15:29–39. https://doi.org/10.1016/j.addma.2017.03.006

36. Salentijn GI, Oomen PE, Grajewski M, et al., 2017, Fused  Deposition Modeling 3D Printing for (Bio)analytical Device Fabrication: Procedures, Materials, and Applications. Anal Chem, 89:7053–61. https://doi.org/10.1021/acs.analchem.7b00828

37. Skowyra J, Pietrzak K, Alhnan MA, 2015, Fabrication of Extended-release Patient-Tailored Prednisolone Tablets Via Fused Deposition Modelling (FDM) 3D Printing. Eur J Pharm Sci, 68:11–7. https://doi.org/10.1016/j.ejps.2014.11.009

38. He Y, Wu Y, Fu JZ, et al., 2016, Developments of 3D Printing Microfluidics and Applications in Chemistry and Biology: A Review. Electroanalysis, 28:1658–78. https://doi.org/10.1002/elan.201600043

39. Lalehpour A, Janeteas C, Barari A, et al., 2018, Surface Roughness of FDM Parts After Post-processing with Acetone Vapor Bath Smoothing Process. Int J Adv Manuf Technol, 95:1505–20. https://doi.org/10.1007/s00170-017-1165-5

40. Kang B, Sung J, So H, 2021, Realization of Superhydrophobic Surfaces Based on Three-Dimensional Printing Technology. Int J Precis Eng Manuf Green Technol, 8:47–55. https://doi.org/10.1007/s40684-019-00163-9

41. Park S, Ko B, Lee H, et al., 2021, Rapid Manufacturing of Micro-drilling Devices using FFF-Type 3D Printing Technology. Sci Rep, 11.1-9. https://doi.org/10.1038/s41598-021-91149-8

42. He Y, Qiu J, Fu J, et al., 2015, Printing 3D Microfluidic Chips with a 3D Sugar Printer, Microfluid Nanofluidics, 19:447–56. https://doi.org/10.1007/s10404-015-1571-7

43. Sung J, So H, 2021, 3D Printing-assisted Fabrication of Microgrid Patterns for Flexible Antiadhesive Polymer Surfaces. Surf Interfaces. 23:100935. https://doi.org/10.1016/j.surfin.2021.100935

44. Amjadi M, Yoon YJ, Park I, 2015, Ultra-stretchable and Skin mountable Strain Sensors using Carbon Nanotubes-ecoflex Nanocomposites. Nanotechnology, 26:375501. https://doi.org/10.1088/0957-4484/26/37/375501

45. Ghassami E, Varshosaz J, Jahanian-Najafabadi A, et al., 2018, Pharmacokinetics and in vitro/In Vivo Antitumor Efficacy of Aptamer-targeted Ecoflex® Nanoparticles for Docetaxel Delivery in Ovarian Cancer. Int J Nanomed, 13:493–504. https://doi.org/10.2147/IJN.S152474

46. Chen CC, Chueh JY, Tseng H, et al., 2003, Preparation and Characterization of Biodegradable PLA Polymeric Blends. Biomaterials, 24:1167–73. https://doi.org/10.1016/s0142-9612(02)00466-0

47. Chuensangjun C, Pechyen C, Sirisansaneeyakul S, 2013, Degradation Behaviors of Different Blends of Polylactic Acid Buried in Soil. Energy Proc, 34:73–82. https://doi.org/10.1016/j.egypro.2013.06.735

48. Erokhin KS, Gordeev EG, Ananikov VP, 2019, Revealing Interactions of Layered Polymeric Materials at Solid-liquid Interface for Building Solvent Compatibility Charts for 3D Printing Applications. Sci Rep, 9:20177. https://doi.org/10.1038/s41598-019-56350-w

49. Yashima S, Takase N, Kurokawa T, et al., 2014, Friction of Hydrogels with Controlled Surface Roughness on Solid Flat Substrates. Soft Matter, 10:3192–9. https://doi.org/10.1039/c3sm52883a

50. Kaler KS, Lama DJ, Safiullah S, et al., 2019, Ureteral Access Sheath Deployment: How Much Force is Too Much? Initial Studies with a Novel Ureteral Access Sheath Force Sensor in the Porcine Ureter. J Endourol, 33:712–8. https://doi.org/10.1089/end.2019.0211

51. Lancastre JJ, Fernandes, N, Margaça FM, et al., 2012, Study of PDMS Conformation in PDMS-based Hybrid Materials Prepared by Gamma Irradiation. Radiat Phys Chem, 81:1336–40. https://doi.org/10.1016/j.radphyschem.2012.02.016

52. Lee J, Kim J, Kim H, et al., 2013, Effect of Thermal Treatment on the Chemical Resistance of Polydimethylsiloxane for Microfluidic Devices. J Micromech Microeng, 23:035007. https://doi.org/10.1088/0960-1317/23/3/035007

53. Zhao Y, Zhu B, Wang Y, et al., 2019, Effect of Different Sterilization Methods on the Properties of Commercial Biodegradable Polyesters for Single-use, Disposable Medical Devices. Mater Sci Eng C, 105:110041. https://doi.org/10.1016/j.msec.2019.110041

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