Sains Malaysiana 53(5)(2024): 1201-1218

http://doi.org/10.17576/jsm-2024-5305-17

 

Developing A Temporary External Fixator (TEF) For Mandibular Reconstruction Using Two-Phase QFD And TRIZ Approach

(Pembangunan Peranti Penetap Luaran Sementara (TEF) untuk Pembinaan Semula Mandibel menggunakan Pendekatan QFD dan TRIZ Dua Fasa)

 

RUNGSAN CHAIYACHET1, APICHART BOONMA1,* & TEERAWAT PAIPONGNA2

 

1Department of Industrial Engineering, Faculty of Engineering, Khon Kaen University, Khon Kaen 40002, Thailand

2Dental Department, Sakon Nakhon Hospital, Sakon Nakhon 47000, Thailand

 

Received: 14 August 2023/Accepted: 22 April 2024

 

Abstract

A temporary external fixator (TEF) is a device used to bridge resection defects after sequestrectomy and before secondary mandibular reconstruction surgery. A well-designed TEF should be customizable and adjustable to accommodate individual patient needs. This study developed a TEF for mandibular reconstruction using the quality function deployment (QFD) and the theory of inventive problem-solving (TRIZ). Customer needs (CNs) were investigated from literature reviews and a survey. Subsequently, a questionnaire was developed, refined, and delivered to 22 experts to identify the essential principles of TEF. Afterwards, the QFD priorities were analyzed based on the acquired CNs and technical requirements (TRs), and the top priorities were found to be safety and adequate operational space. The guidelines for developing a TEF with TRIZ were established as follows: First, using carbon fiber epoxy composite and Ti-6Al-4V as the material for TEFs is recommended Second, permanent magnet should be inserted into the clamp lock bolts to prevent them from falling off during surgery. Last, replacing one Schanz screw with three Bicortical screws is recommended for the fixator pins. Additionally, it was also found that changing the screw size from 2.5–4.0 mm to 2.0–2.4 mm could reduce hole defects in the mandible.    

 

Keywords: Mandibular reconstruction; quality function deployment; temporary external fixator; theory of inventive problem-solving

 

Abstrak

Penetap luaran sementara (TEF) adalah peranti yang digunakan selepas sekuestrektomi dan sebelum pembedahan kedua pembinaan semula mandibel untuk mengantara kelompangan kesan reseksi. Rekaan TEF yang baik haruslah boleh disesuaikan dan dilaraskan untuk memenuhi keperluan setiap pesakit. Kajian pembangunan TEF untuk pembinaan semula mandibel ini menggunakan kaedah penerapan ciri berkualiti (QFD) dan teori penyelesaian masalah inventif (TRIZ). Kaedah kajian yang digunakan untuk mengetahui keperluan pelanggan (CNs) adalah daripada tinjauan kepustakaan dan kaedah tinjauan. Satu set soal selidik kemudiannya dibangunkan, diperinci dan dihantar kepada 22 pakar untuk mengenal pasti prinsip penting TEF. Seterusnya, keutamaan QFD dianalisis berdasarkan CNs dan keperluan teknikal (TRs) tersebut. Keutamaan tertinggi adalah keselamatan dan ruang operasi yang mencukupi; oleh itu, garis panduan untuk membangunkan TEF melalui TRIZ telah ditetapkan. Pertama, adalah disyorkan untuk menggunakan komposit epoksi gentian karbon dan Ti-6Al-4V sebagai bahan untuk TEF. Kedua, magnet kekal hendaklah dimasukkan ke dalam bolt kunci pengapit untuk mengelakkannya daripada jatuh semasa pembedahan. Dan terakhir, disyorkan untuk menggantikan satu skru Schanz pada pin penetap dengan tiga skru mini. Kajian juga mendapati bahawa mengubah saiz skru dari 2.5–4.0 mm kepada 2.0-2.4 mm boleh mengurangkan kecacatan lubang di mandibel.

Kata kunci: Kaedah penerapan ciri berkualiti; pembinaan semula mandibel; penetap luaran sementara; teori penyelesaian masalah inventif

 

REFERENCES

Alaneme, K.K., Kareem, S.A., Ozah, B.N., Alshahrani, H.A. & Ajibuwa, O.A. 2022. Application of finite element analysis for optimizing selection and design of Ti-based biometallic alloys for fractures and tissues rehabilitation: A review. Journal of Materials Research and Technology 19: 121-139. https://doi.org/10.1016/j.jmrt.2022.05.001

Alencar, M.G.M., Bortoli, M.M., Silva, T.C.G.D., Silva, E.D.O.E. & Laureano Filho, J.R. 2018. Suitability of wrist external fixator for treatment of mandibular fracture. The Journal of Craniofacial Surgery 29(4): e371-e372. https://doi.org/10.1097/SCS.0000000000004375

Amaro, A.M., Paulino, M.F., Roseiro, L.M. & Neto, M.A. 2020. The effect of external fixator configurations on the dynamic compression load: An experimental and numerical study. Applied Sciences 10(1): 3. https://doi.org/10.3390/app10010003

Ameen, W., Al-Ahmari, A., Mohammed, M.K., Abdulhameed, O., Umer, U. & Moiduddin, K. 2018. Design, finite element analysis (FEA) and fabrication of custom titanium alloy cranial implant using electron beam melting additive manufacturing. Advances in Production Engineering and Management 13(3): 267-278. https://doi.org/10.14743/apem2018.3.289

Ameerally, P.J. & Hollows, P. 2004. Use of an external fixator to stabilise the proximal mandibular during reconstruction. British Journal of Oral and Maxillofacial Surgery 42(4): 354-356. https://doi.org/10.1016/j.bjoms.2004.02.031

Annino Jr., D.J., Sethi, R.K., Hansen, E.E., Horne, S., Dey, T., Rettig, E.M., Uppaluri, R., Kass, J.I. & Goguen, L.A. 2022. Virtual planning and 3D-printed guides for mandibular reconstruction: Factors impacting accuracy. Laryngoscope Investig. Otolaryngol. 7(6): 1798-1807. https://doi/10.1002/lio2.830

AO Foundation. 2022. Safe zones for pin placement in the mandible. https://www.aofoundation.org/ (Accessed on January 7, 2024).

Bak, M., Jacobson, A.S., Buchbinder, D. & Urken, M.L. 2010. Contemporary reconstruction of the mandible. Oral Oncology 46(2): 71-76. https://doi.org/10.1016/j.oraloncology.2009.11.006

Barr, M.L., Haveles, C.S., Rezzadeh, K.S., Nolan, I.T., Castro, R., Lee, J.C., Steinbacher, D. & Pfaff, M.J. 2020. Virtual surgical planning for mandibular reconstruction with the fibula free flap: A systematic review and meta-analysis. Annals of Plastic Surgery 84(1): 117-122. https://doi.org/10.1097/SAP.0000000000002006

Basat, P., Estrella, E. & Magdaluyo, E. 2020. Material selection and design of external fixator clamp for metacarpal fractures. Materials Today: Proceedings 33. https://doi.org/10.1016/j.matpr.2020.06.129

Braidy, H.F. & Ziccardi, V.B. 2009. External fixation for mandible fractures. Atlas of the oral and maxillofacial surgery clinics of North America 17(1): 45-53. https://doi.org/10.1016/j.cxom.2008.10.001

Brown, J.S., Barry, C., Ho, M. & Shaw, R. 2016. A new classification for mandibular defects after oncological re-section. The Lancet Oncology 17(4): e23-e30. https://doi.org/10.1016/S1470-2045(15)00310-1

Carpinello, A., Vezzetti, E., Ramieri, G., Moos, S., Novaresio, A., Zavattero, E. & Borbon, C. 2021. Evaluation of HMDS by QFD for augmented reality applications in the maxillofacial surgery domain. Applied Sciences 11(22): 11053.  https://doi.org/10.3390/app112211053

Chan, L-K. & Wu, M-L. 2002. Quality function deployment: A literature review. European Journal of Operational Research 143(3): 463-497. https://doi.org/10.1016/S0377-2217(02)00178-9

Chaus, G.W., Dukes, C., Hak, D.J., Mauffrey, C. & Hammerberg, E.M. 2014. Analysis of usage and associated cost of external fixators at an urban level 1 trauma centre. Injury 45(10): 1611-1613. https://doi.org/10.1016/j.injury.2014.04.031

Chou, J.R. 2021. A TRIZ-based product-service design approach for developing innovative products. Computers and Industrial Engineering 161(1): 107608. https://doi.org/10.1016/j.cie.2021.107608

Cornelius, C.P., Augustin, J.B. & Sailer, L.K. 2009. External pin fixation for stabilization of the mandible - Come-back of a method: Historical review and first experiences with the "mandible external fixator". Oral and Maxillofacial Surgery 13(1): 1-14. https://doi.org/10.1007/s10006-008-0142-4

De Mello-Filho, F.V., Auader, M., Cano, E., Carrau, R.L., Myers, E.N. & Miles, C.E. 2003. Effect of mandibular titanium reconstructive plates on radiation dose. American Journal of Otolaryngology - Head and Neck Medicine and Surgery 24(4): 231-235. https://doi.org/10.1016/S0196-0709(03)00033-4

El-Haik, B.S. & Mekki, K.S. 2008. DFSS innovation for medical devices. Medical Device Design for Six Sigma: A Road Map for Safety and Effectiveness. New York: John Wiley and Sons Inc. https://doi.org/10.1002/9780470264003

Farrahshaida, M.S., Abu, B.S., Muhammad, R.R., Norhamidi, M. & Lim, T.F. 2017. Effect of space holders on fabrication of porous titanium alloy-hydroxyapatite composite through powder injection molding. Sains Malaysiana 46(9): 1651-1657. http://dx.doi.org/10.17576/jsm-2017-4609-38

Frizziero, L., Francia, D., Donnici, G., Liverani, A. & Caligiana, G. 2018. Sustainable design of open molds with QFD and TRIZ combination. Journal of Industrial and Production Engineering 35(1): 21-31. https://doi.org/10.1080/21681015.2017.1385543

Funayama, A., Kojima, T., Yoshizawa, M., Mikami, T., Kanemaru, S., Niimi, K., Oda, Y., Kato, Y. & Kobayashi, T. 2017. A simple technique for repositioning of the mandible by a surgical guide prepared using a three-dimensional model after segmental mandibulectomy. Maxillofacial Plastic and Reconstructive Surgery 39(1): 16. https://doi.org/10.1186/s40902-017-0113-5

Fung, R.Y.K., Tang, J., Tu, Y. & Wang, D. 2002. Product design resources optimization using a non-linear fuzzy quality function deployment model. International Journal of Production Research 40(3): 585-599. https://doi.org/10.1080/00207540110061634

Ghane, M., Ang, M.C., Cavallucci, D., Abdul Kadir, R., Ng, K.W. & Sorooshian, S. 2022. TRIZ trend of engineering system evolution: A review on applications, benefits, challenges and enhancement with computer-aided aspects. Computers & Industrial Engineering 174: 108833. https://doi.org/10.1016/j.cie.2022.108833

Gibbons, A.J., Mackenzie, N. & Breederveld, R.S. 2011. Use of a custom designed external fixator system to treat ballistic injuries to the mandible. International Journal of Oral and Maxillofacial Surgery 40(1): 103-105. https://doi.org/10.1016/j.ijom.2010.08.001

Grant, J.S. & Davis, L.L. 1997. Selection and use of content experts for instrument development. Research in Nursing & Health 20(3): 269-274. https://doi.org/10.1002/(sici)1098-240x(199706)20:3<269::aid-nur9>3.0.co;2-g

Hihara, M., Yagura, T., Takegawa, M., Kakudo, N., Morimoto, N. & Kusumoto, K. 2019. A novel fixation method for panfacial fracture using an Ilizarov-type external fixator. Trauma Case Reports 22: 100214. https://doi.org/10.1016/j.tcr.2019.100214

Ho, M.W., Brown, J.S. & Shaw, R.J. 2013. Intraoperative temporary fixation for primary reconstruction of composite mandibular ablative defects. The British Journal of Oral & Maxillofacial Surgery 51(8): 976-977. https://doi.org/10.1016/j.bjoms.2013.05.156

Jia, G.Z. & Bai, M. 2011. An approach for manufacturing strategy development based on fuzzy-QFD. Computers & Industrial Engineering 60(3): 445-454. https://doi.org/10.1016/j.cie.2010.07.003

Kammoun, A., Hachicha, W. & Aljuaid, A.M. 2021. Integrating quality tools and methods to analyze and improve a hospital sterilization process. Healthcare 9(5): 1-13. https://doi.org/10.3390/healthcare9050544

Kang, C.Q., Ng, P.K. & Liew, K.W. 2022. A TRIZ-Integrated conceptual design process of a smart lawnmower for uneven grassland. Agronomy 12(11): 2728. https://doi.org/10.3390/agronomy12112728

Kazi, A.A., Lee, T.S., Vincent, A., Sokoya, M., Sheen, D. & Ducic, Y. 2019. The role of external fixation in trauma and reconstruction of the mandible in the age of rigid fixation. Facial Plastic Surgery 35(6): 614-622. https://doi.org/10.1055/s-0039-1700799

Lynn, M. 1986. Determination and quantification of content validity index. Nursing Research 35: 382-386. https://doi.org/10.1097/00006199-198611000-00017

Manam, N.S., Harun, W.S.W., Shri, D.N.A., Ghani, S.A.C., Kurniawan, T., Ismail, M.H. & Ibrahim, M.H.I. 2017. Study of corrosion in biocompatible metals for implants: A review. Journal of Alloys and Compounds 701: 698-715. https://doi.org/10.1016/j.jallcom.2017.01.196

Marti-Flich, L., Schlund, M., Raoul, G., Maes, J-M., Ferri, J., Wojcik, T. & Nicot, R. 2020. Twenty-four years of experience in management of complex mandibular fractures with low cost, custom-made mandibular external fixation: A 65-patient series. Journal of Stomatology, Oral and Maxillofacial Surgery 121(3): 242-247. https://doi.org/10.1016/j.jormas.2019.08.008

McChesney, G.R., Morris, R.P., Al Barghouthi, A., Travascio, F., Latta, L.L. & Lindsey, R.W. 2022. Relationship to drill bit diameter and residual fracture resistance of the distal tibia. Clinical Biomechanics 97: 105686. https://doi.org/10.1016/j.clinbiomech.2022.105686

Melgoza, E.L., Serenó, L., Rosell, A. & Ciurana, J. 2012. An integrated parameterized tool for designing a customized tracheal stent. Computer-Aided Design 44(12): 1173-1181. https://doi.org/10.1016/j.cad.2012.07.004

Mohamed, A., Mepani, V. & Sharma, V. 2020. Use of an endotracheal tube in the biphasic fixation of a mandibular fracture. British Journal of Oral and Maxillofacial Surgery 58(4): 484-485. https://doi.org/10.1016/j.bjoms.2020.01.025

Moiduddin, K., Mian, S.H., Alkhalefah, H. & Umer, U. 2019. Digital design, analysis and 3D printing of prosthesis scaffolds for mandibular reconstruction. Metals 9: 569. https://doi.org/10.3390/met9050569

Nurul Nadiah Mahmud, Abu Bakar Sulong & Ameyama, K. 2023. Powder injection moulded Ti-6Al-4V-HA composite for implants. Sains Malaysiana 52(5): 1557-1565. https://doi.org/10.17576/jsm-2023-5205-17

Odono, L.T., Brady, C.M. & Urata, M. 2019. Mandible fractures. In Facial Trauma Surgery: from Primary Repair to Reconstruction, edited by Dorafshar, A.H., Rodriguez, E.D. & Manson, P.N. New York: Elsevier. https://doi.org/10.1016/B978-0-323-49755-8.00022-0

Pamias-Romero, J., Saez-Barba, M., de-Pablo-García-Cuenca, A., Vaquero-Martínez, P., Masnou-Pratdesaba, J. & Bescós-Atín, C. 2023. Quality of life after mandibular reconstruction using free fibula flap and customized plates: A case series and comparison with the literature. Cancers 15(9): 2582. https://doi.org/10.3390/cancers15092582

Patel, A., Harrison, P., Cheng, A., Bray, B. & Bell, R.B. 2019. Fibular reconstruction of the maxilla and mandible with immediate implant-supported prosthetic rehabilitation: Jaw in a day. Oral and Maxillofacial Surgery Clinics of North America 31(3): 369-386. https://doi.org/10.1016/j.coms.2019.03.002

Peled, M., El-Naaj, I. A., Lipin, Y., & Ardekian, L. 2005. The use of free fibular flap for functional mandibular reconstruction. Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons 63(2): 220–224. https://doi.org/10.1016/j.joms.2004.06.052

Pereira-Filho, V.A., da Silva, B.N., Nunes Reis, J.M., Spin-Neto, R., Real Gabrielli, M.F. & Monnazzi, M.S. 2013. Effect of the number of screws on the stability of locking mandibular reconstruction plates. Int. J. Oral Maxillofac. Surg. 42(6): 732-735. https://doi.org/10.1016/j.ijom.2013.02.010

Polit, D.E. & Beck, C.T. 2006. Essentials of Nursing Research. 6th ed. Philadelphia: Lippincott Williams & Wilkins.

Purushothaman, K. & Ahmad, R. 2022. Integration of six sigma methodology of DMADV steps with QFD, DFMEA and TRIZ applications for image-based automated inspection system development: A case study. International Journal of Lean Six Sigma 13(6): 1239-1276. https://doi.org/10.1108/IJLSS-05-2021-0088

Riccio, S., Tagliabue, M., Soncini, G., Giugliano, G., Bruschini, R., Zorzi, S., De Benedetto, L., Chu, F., De Berardinis, R. & Ansarin, M. 2021. An innovative tool for mandibular reconstruction in oral malignancies: A pictorial essay. Journal of Stomatology, Oral and Maxillofacial Surgery 122(4): e81-e84. https://doi.org/10.1016/j.jormas.2021.03.010

Roy, M.K., Ray, A. & Pradhan, B.B. 2014. Non-traditional machining process selection using integrated fuzzy AHP and QFD techniques: A customer perspective. Production & Manufacturing Research 2(1): 530-549. https://doi.org/10.1080/21693277.2014.938276

Shakouri, E., Haghighi Hassanalideh, H. & Fotuhi, S. 2021. Bone drilling with internal gas cooling: experimental and statistical investigation of the effect of cooling with CO2 on reduction of temperature rise due to drill bit wear. Advances in Production Engineering and Management 16(2): 199-211. https://doi.org/10.14743/APEM2021.2.394

Shaw, R.B., Katzel, E.B., Koltz, P.F., Yaremchuk, M.J., Girotto, J.A., Kahn, D.M. & Langstein, H.N. 2011. Aging of the facial skeleton: Aesthetic implications and rejuvenation strategies. Plastic and Reconstructive Surgery 127(1): 374-383. https://doi.org/10.1097/PRS.0b013e3181f95b2d

Shen, S.Y., Yu, Y., Zhang, W.B., Liu, X.J. & Peng, X. 2017. Angle-to-angle mandibular defect reconstruction with fibula flap by using a mandibular fixation device and surgical navigation. The Journal of Craniofacial Surgery 28(6): 1486-1491. https://doi.org/10.1097/SCS.0000000000003891

Singh, P. & Agrawal, G. 2022. Mapping the customer centric weather index insurance service design using quality function deployment. The TQM Journal 34(6): 1800-1822. https://doi.org/10.1108/TQM-08-2021-0236

Streiner, D.L., Norman, G.R. & Cairney, J. 2015. Health Measurement Scales: A Practical Guide to Their Development and Use. 5th ed. Oxford: Oxford University Press.

Tortorella, G.L., Fogliatto, F.S., Sunder, M.V., Vergara, A.M.C. & Vassolo, R. 2022. Assessment and prioritisation of Healthcare 4.0 implementation in hospitals using quality function deployment. International Journal of Production Research 60(10): 3147-3169. https://doi.org/10.1080/00207543.2021.1912429

Tümer, D., Güngörürler, M., Havıtçıoğlu, H. & Arman, Y. 2020. Investigation of effective coating of the Ti–6Al–4V alloy and 316L stainless steel with graphene or carbon nanotubes with finite element methods. Journal of Materials Research and Technology 9(6): 15880-15893. https://doi.org/10.1016/j.jmrt.2020.11.052

Ung, F., Rocco, J.W. & Deschler, D.G. 2002. Temporary intraoperative external fixation in mandibular reconstruction. The Laryngoscope 112(9): 1569-1573. https://doi.org/10.1097/00005537-200209000-00006

Vural, E. & Yuen, J.C. 2007. Combining use of resin models with external fixation in mandibular reconstruction. Archives of Otolaryngology, Head & Neck Surgery 133(6): 603-607. https://doi.org/10.1001/archotol.133.6.603

Wang, Y.H., Lee, C.H. & Trappey, A.J.C. 2017. Service design blueprint approach incorporating TRIZ and service QFD for a meal ordering system: A case study. Computers & Industrial Engineering 107: 388-400. https://doi.org/10.1016/j.cie.2017.01.013

Yang, W., Cao, G., Peng, Q. & Sun, Y. 2021. Effective radical innovations using integrated QFD and TRIZ. Computers & Industrial Engineering 162: 107716. https://doi.org/10.1016/j.cie.2021.107716

Yin, X.L., Tan, Y.R., Liu, Y., Sun, W.W., Zhang, X.Y., Hu, Y.J., Sun, J., Zhang, C.P. & Zhong, L.P. 2019. Clinical application of temporary external fixator for immediate mandibular reconstruction. The Journal of Craniofacial Surgery 30(4): e337-e342. https://doi.org/10.1097/SCS.0000000000005303

You, Z.H., Bell, W.H., Schneiderman, E.D. & Ashman, R.B. 1994. Biomechanical properties of small bone screws. Journal of Oral and Maxillofacial Surgery 52(12): 1293-1302. https://doi.org/10.1016/0278-2391(94)90052-3

Zhang, F., Yang, M. & Liu, W. 2014. Using integrated quality function deployment and theory of innovation problem solving approach for ergonomic product design. Computers & Industrial Engineering 76: 60-74. https://doi.org/10.1016/j.cie.2014.07.019

Zhang, X., Li, J., Fan, K., Chen, Z., Hu, Z. & Yu, Y. 2019. Neural approximation enhanced predictive tracking control of a novel designed four-wheeled rollator. Applied Sciences 10: 125. https://doi.org/10.3390/app10010125

 

*Corresponding author; email: Apicbo@kku.ac.th

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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