Design, 3D modeling and mechanoacoustical behaviour optimization of a new ventilation tube
Abstract Introduction and Objetive: We show a new trans-tympanic ventilation tube whose design and mass are intended to solve the undesirable effects that appeared during the insertion of currently commercialized ventilation tubes; We analyze its mechanical behavior in a 3D model of the ear in order to optimize its acoustic behavior. Methods: For the design of the tube an autoCAD software was used; The mechanical behavior was analyzed in a 3D dynamic computerized model of the human ear based on the finite element method (FEM). Results: The new ventilation tube has a size and mass significantly smaller than those currently available in the market, which causes less interference in the vibration of the eardrum-osicular system; Its design facilitates it to remain inserted while the patient's conditions so advise avoiding its fall into the middle ear cavity or its early extrusion. Conclusions: The biological and acoustic advantages of the new developed tube (with less mass and whose design avoids the complications of the current ones) can open a new possibility of treatment of chronic seromucous otitis media.
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1. Bray D, Owa A. How we do it: OWA (Addengrookes) grommet. Clin Otolaryngol. 2006;31:62-3.
2. D’Eredita R, Marsh RR. Tympanic membrane healing process and biocompatibility of an innovative absorbable ventilation tube. Otol Neurotol 2006;7:65–70.
3. Park AH, Hoyt D, Britt D, Chase S, Transavatdi K, Hunter L, Sheng X, Prestwich GD. Cross-linked hydrogel and polyester reservable ventilation tubes in chinchilla model. Laryngoscope 2013;123:1043-8.
4. Crysdale WS. Comparative study of various ventilating tubes. Ann Otol Rhinol. Laryngol. 1976;85:268–9.
5. Gil-Carcedo E, Pérez-López B, Vallejo LA, Gil-Carcedo LM, Montoya F. Modelo Computadorizado 3-D para el estudio de la biomecánica del oído medio con el Método de los Elementos Finitos (MEF) Acta Otorrinolaringológica Española 2002;53: 527-37.
6. Vlaming MSMG, Feenstra L. Studies on the mechanics of the normal human middle ear. Clinical Otolaryngology 1986;11:353-63.
7. Ito M, Takahashi H, Iino Y, et al. Clinical practice guidelines for the diagnosis and management of otitis media with effusion (OME) in children in Japan, 2015. Auris Nasus Larynx. 2017;44(5):501–8.
8. Simon F, Haggard M, Rosenfeld RM, et al. International consensus (ICON) on management of otitis media with effusion in children. Eur Ann Otorhinolaryngol Head Neck Dis. 2018;135(1S):S33–S39.
9. Vanneste P, Page C. Otitis media with effusion in children: Pathophysiology, diagnosis, and treatment. A review. J Otol. 2019;14(2):33–9
10. Rosenfeld RM, Schwartz SR, Pynnonen MA, et al. Clinical practice guideline: Tympanostomy tubes in children. Otolaryngol Head Neck Surg. 2013;149(1 Suppl):S1–S35.
11. Söderman AC, Knutsson J, Priwin C, von Unge M. A randomized study of four different types of tympanostomy ventilation tubes - One-year follow-up. Int J Pediatr Otorhinolaryngol. 2016;89:159–63.
12. Hellström S, Groth A, Jörgensen F, Pettersson A, Ryding M, Uhlén I, Boström KB. Ventilation tube treatment: a systematic review of the literature. Otolaryngol Head Neck Surg. 2011;145:383-95.
13. Fergie N, Bayston R, Pearson JP, Birchall JP. Is otitis media with effusion a biofilm infection?. Clin Otolaryngol Allied Sci. 2004;29(1):38–46.
14. Hall-Stoodley L, Hu FZ, Gieseke A, et al. Direct detection of bacterial biofilms on the middle-ear mucosa of children with chronic otitis media. JAMA. 2006;296(2):202–11.
15. Van Hoecke H, De Paepe AS, Lambert E, et al. Haemophilus influenzae biofilm formation in chronic otitis media with effusion. Eur Arch Otorhinolaryngol. 2016;273(11):3553–60.
16. Blanc F, Ayache D, Calmels MN, et al. Management of otitis media with effusion in children. Société française d'ORL et de chirurgie cervico-faciale clinical practice guidelines. Eur Ann Otorhinolaryngol Head Neck Dis. 2018;135(4):269–73.
17. Maris M, Wojciechowski M, Van de Heyning P, Boudewyns A. A cross-sectional analysis of otitis media with effusion in children with Down syndrome. Eur J Pediatr. 2014;173(10):1319–25.
18. Browning GG, Rovers MM, Williamson I, Lous J, Burton MJ. Grommets (ventilation tubes) for hearing loss associated with otitis media with effusion in children. Cochrane Database Syst Rev. 2010;(10):CD001801.
19. Lindstrom DR, Reuben B, Jacobson K, Flanary VA, Kerschner JE. Long-term results of Armstrong beveled grommet tympanostomy tubes in children. Laryngoscope. 2004;114(3):490–4.
20. De Beer BA, Schilder AG, Zielhuis GA, Graamans K. Natural course of tympanic membrane pathology related to otitis media and ventilation tubes between ages 8 and 18 years. Otol Neurotol. 2005;26(5):1016–21.
21. Johnston LC, Feldman HM, Paradise JL, et al. Tympanic membrane abnormalities and hearing levels at the ages of 5 and 6 years in relation to persistent otitis media and tympanostomy tube insertion in the first 3 years of life: a prospective study incorporating a randomized clinical trial. Pediatrics. 2004;114(1):e58–e67.
22. Djurhuus BD, Christensen K, Skytthe A, Faber CE. The impact of ventilation tubes in otitis media on the risk of cholesteatoma on a national level. Int J Pediatr Otorhinolaryngol. 2015;79(4):605–9.
23. Wallace IF, Berkman ND, Lohr KN, Harrison MF, Kimple AJ, Steiner MJ. Surgical treatments for otitis media with effusion: a systematic review. Pediatrics. 2014;133(2):296–311.
24. Rosenfeld RM, Shin JJ, Schwartz SR, et al. Clinical Practice Guideline: Otitis Media with Effusion (Update). Otolaryngol Head Neck Surg. 2016;154(1 Suppl):S1–S41.
25. Vlastarakos PV, Nikolopoulos TP, Korres S, Tavoulari E, Tzagaroulakis A, Ferekidis E. Grommets in otitis media with effusion: the most frequent operation in children. But is it associated with significant complications?. Eur J Pediatr. 2007;166(5):385–91.
26. Antonelli PJ, Sampson EM, Ojano-Dirain C. Biofilm formation on silicone tympanostomy tubes with polyvinylpyrrolidone coating. Arch Otolaryngol Head Neck Surg. 2011;137(1):19–23.
27. Jang CH, Cho YB, Choi CH. Effect of ion-bombarded silicone tympanostomy tube on ciprofloxacin-resistant Pseudomonas aeruginosa biofilm formation. Int J Pediatr Otorhinolaryngol. 2012;76(10):1471–3.
28. Saidi IS, Biedlingmaier JF, Whelan P. In vivo resistance to bacterial biofilm formation on tympanostomy tubes as a function of tube material. Otolaryngol Head Neck Surg. 1999;120(5):621–7.
29. Wang JC, Tran PL, Hanes R, et al. Inhibition of otopathogenic biofilms by organoselenium-coated tympanostomy tubes. JAMA Otolaryngol Head Neck Surg. 2013;139(10):1009–16.
30. Hong P, Smith N, Johnson LB, Corsten G. A randomized double-blind controlled trial of phosphorylcholine-coated tympanostomy tube versus standard tympanostomy tube in children with recurrent acute and chronic otitis media. Laryngoscope. 2011;121(1):214–9.
31. Kay DJ, Nelson M, Rosenfeld RM. Meta-analysis of tympanostomy tube sequelae. Otolaryngol Head Neck Surg. 2001;124(4):374–80.
32. Dingle AF, Flood LM, Kumar BU, Newcombe RC. Tympanosclerosis and mini grommets: the relevance of grommet design. J Laryngol Otol. 1995;109(10):922–5.
33. Kazikdas KC, Serbetcioglu B, Boyraz I, et al. Tympanometric changes in an experimental myringosclerosis model after myringotomy. Otol Neurotol. 2006;27(3):303–7.
34. Prendergast PJ; Kelly DJ; Rafferty M, Blayney AW. The effect of ventilation tubes on stresses and vibration motion in the tympanic membrane: a finite element analysis. Clin Otolaryngol Allied Sci. 1999;24:542-8.
2. D’Eredita R, Marsh RR. Tympanic membrane healing process and biocompatibility of an innovative absorbable ventilation tube. Otol Neurotol 2006;7:65–70.
3. Park AH, Hoyt D, Britt D, Chase S, Transavatdi K, Hunter L, Sheng X, Prestwich GD. Cross-linked hydrogel and polyester reservable ventilation tubes in chinchilla model. Laryngoscope 2013;123:1043-8.
4. Crysdale WS. Comparative study of various ventilating tubes. Ann Otol Rhinol. Laryngol. 1976;85:268–9.
5. Gil-Carcedo E, Pérez-López B, Vallejo LA, Gil-Carcedo LM, Montoya F. Modelo Computadorizado 3-D para el estudio de la biomecánica del oído medio con el Método de los Elementos Finitos (MEF) Acta Otorrinolaringológica Española 2002;53: 527-37.
6. Vlaming MSMG, Feenstra L. Studies on the mechanics of the normal human middle ear. Clinical Otolaryngology 1986;11:353-63.
7. Ito M, Takahashi H, Iino Y, et al. Clinical practice guidelines for the diagnosis and management of otitis media with effusion (OME) in children in Japan, 2015. Auris Nasus Larynx. 2017;44(5):501–8.
8. Simon F, Haggard M, Rosenfeld RM, et al. International consensus (ICON) on management of otitis media with effusion in children. Eur Ann Otorhinolaryngol Head Neck Dis. 2018;135(1S):S33–S39.
9. Vanneste P, Page C. Otitis media with effusion in children: Pathophysiology, diagnosis, and treatment. A review. J Otol. 2019;14(2):33–9
10. Rosenfeld RM, Schwartz SR, Pynnonen MA, et al. Clinical practice guideline: Tympanostomy tubes in children. Otolaryngol Head Neck Surg. 2013;149(1 Suppl):S1–S35.
11. Söderman AC, Knutsson J, Priwin C, von Unge M. A randomized study of four different types of tympanostomy ventilation tubes - One-year follow-up. Int J Pediatr Otorhinolaryngol. 2016;89:159–63.
12. Hellström S, Groth A, Jörgensen F, Pettersson A, Ryding M, Uhlén I, Boström KB. Ventilation tube treatment: a systematic review of the literature. Otolaryngol Head Neck Surg. 2011;145:383-95.
13. Fergie N, Bayston R, Pearson JP, Birchall JP. Is otitis media with effusion a biofilm infection?. Clin Otolaryngol Allied Sci. 2004;29(1):38–46.
14. Hall-Stoodley L, Hu FZ, Gieseke A, et al. Direct detection of bacterial biofilms on the middle-ear mucosa of children with chronic otitis media. JAMA. 2006;296(2):202–11.
15. Van Hoecke H, De Paepe AS, Lambert E, et al. Haemophilus influenzae biofilm formation in chronic otitis media with effusion. Eur Arch Otorhinolaryngol. 2016;273(11):3553–60.
16. Blanc F, Ayache D, Calmels MN, et al. Management of otitis media with effusion in children. Société française d'ORL et de chirurgie cervico-faciale clinical practice guidelines. Eur Ann Otorhinolaryngol Head Neck Dis. 2018;135(4):269–73.
17. Maris M, Wojciechowski M, Van de Heyning P, Boudewyns A. A cross-sectional analysis of otitis media with effusion in children with Down syndrome. Eur J Pediatr. 2014;173(10):1319–25.
18. Browning GG, Rovers MM, Williamson I, Lous J, Burton MJ. Grommets (ventilation tubes) for hearing loss associated with otitis media with effusion in children. Cochrane Database Syst Rev. 2010;(10):CD001801.
19. Lindstrom DR, Reuben B, Jacobson K, Flanary VA, Kerschner JE. Long-term results of Armstrong beveled grommet tympanostomy tubes in children. Laryngoscope. 2004;114(3):490–4.
20. De Beer BA, Schilder AG, Zielhuis GA, Graamans K. Natural course of tympanic membrane pathology related to otitis media and ventilation tubes between ages 8 and 18 years. Otol Neurotol. 2005;26(5):1016–21.
21. Johnston LC, Feldman HM, Paradise JL, et al. Tympanic membrane abnormalities and hearing levels at the ages of 5 and 6 years in relation to persistent otitis media and tympanostomy tube insertion in the first 3 years of life: a prospective study incorporating a randomized clinical trial. Pediatrics. 2004;114(1):e58–e67.
22. Djurhuus BD, Christensen K, Skytthe A, Faber CE. The impact of ventilation tubes in otitis media on the risk of cholesteatoma on a national level. Int J Pediatr Otorhinolaryngol. 2015;79(4):605–9.
23. Wallace IF, Berkman ND, Lohr KN, Harrison MF, Kimple AJ, Steiner MJ. Surgical treatments for otitis media with effusion: a systematic review. Pediatrics. 2014;133(2):296–311.
24. Rosenfeld RM, Shin JJ, Schwartz SR, et al. Clinical Practice Guideline: Otitis Media with Effusion (Update). Otolaryngol Head Neck Surg. 2016;154(1 Suppl):S1–S41.
25. Vlastarakos PV, Nikolopoulos TP, Korres S, Tavoulari E, Tzagaroulakis A, Ferekidis E. Grommets in otitis media with effusion: the most frequent operation in children. But is it associated with significant complications?. Eur J Pediatr. 2007;166(5):385–91.
26. Antonelli PJ, Sampson EM, Ojano-Dirain C. Biofilm formation on silicone tympanostomy tubes with polyvinylpyrrolidone coating. Arch Otolaryngol Head Neck Surg. 2011;137(1):19–23.
27. Jang CH, Cho YB, Choi CH. Effect of ion-bombarded silicone tympanostomy tube on ciprofloxacin-resistant Pseudomonas aeruginosa biofilm formation. Int J Pediatr Otorhinolaryngol. 2012;76(10):1471–3.
28. Saidi IS, Biedlingmaier JF, Whelan P. In vivo resistance to bacterial biofilm formation on tympanostomy tubes as a function of tube material. Otolaryngol Head Neck Surg. 1999;120(5):621–7.
29. Wang JC, Tran PL, Hanes R, et al. Inhibition of otopathogenic biofilms by organoselenium-coated tympanostomy tubes. JAMA Otolaryngol Head Neck Surg. 2013;139(10):1009–16.
30. Hong P, Smith N, Johnson LB, Corsten G. A randomized double-blind controlled trial of phosphorylcholine-coated tympanostomy tube versus standard tympanostomy tube in children with recurrent acute and chronic otitis media. Laryngoscope. 2011;121(1):214–9.
31. Kay DJ, Nelson M, Rosenfeld RM. Meta-analysis of tympanostomy tube sequelae. Otolaryngol Head Neck Surg. 2001;124(4):374–80.
32. Dingle AF, Flood LM, Kumar BU, Newcombe RC. Tympanosclerosis and mini grommets: the relevance of grommet design. J Laryngol Otol. 1995;109(10):922–5.
33. Kazikdas KC, Serbetcioglu B, Boyraz I, et al. Tympanometric changes in an experimental myringosclerosis model after myringotomy. Otol Neurotol. 2006;27(3):303–7.
34. Prendergast PJ; Kelly DJ; Rafferty M, Blayney AW. The effect of ventilation tubes on stresses and vibration motion in the tympanic membrane: a finite element analysis. Clin Otolaryngol Allied Sci. 1999;24:542-8.
Vallejo-Valdezate, L. Ángel, Bragado, A., Hidalgo-Otamendi, A., Gil-Carcedo, E., Herrero-Calvo, D., & Fernandez-Cascón, S. (2020). Design, 3D modeling and mechanoacoustical behaviour optimization of a new ventilation tube. Revista ORL, 11(4), 413–425. https://doi.org/10.14201/orl.22759
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