上海交通大学学报（医学版）

上海交通大学学报（医学版） >

2023 , Vol. 43 >Issue 5: 524 - 531

DOI: https://doi.org/10.3969/j.issn.1674-8115.2023.05.002

口腔外科专题

国产定制型全颞下颌关节假体的研发与应用

  • 陈旭卓 ,
  • 毛懿 ,
  • 袁丹 ,
  • 张善勇 ,
  • 杨驰
展开
  • 上海交通大学医学院附属第九人民医院口腔外科，上海交通大学口腔医学院，国家口腔医学中心，国家口腔疾病临床医学研究中心，上海市口腔医学重点实验室，上海 200011
陈旭卓（1994—），男，住院医师，博士；电子信箱：cxzzxcaa@126.com。
袁　丹，电子信箱：yuandanan0205@163.com。
张善勇，电子信箱：zhangshanyong@126.com

收稿日期: 2023-04-07

  录用日期: 2023-05-04

  网络出版日期: 2023-07-11

基金资助

上海市科学技术委员会优秀技术带头人项目(21XD1431500);上海申康医院发展中心临床3年行动计划(SHDC2020CR3060B);上海市黄浦区产业扶持基金(XK2020013)

收起

Development and application of Chinese customized total temporomandibular joint prosthesis

  • Xuzhuo CHEN ,
  • Yi MAO ,
  • Dan YUAN ,
  • Shanyong ZHANG ,
  • Chi YANG
Expand
  • Department of Oral Surgery, Shanghai Ninth People′s Hospital, Shanghai Jiao Tong University School of Medicine; College of Stomatology, Shanghai Jiao Tong University; National Center for Stomatology; National Clinical Research Center for Oral Diseases; Shanghai Key Laboratory of Stomatology, Shanghai 200011, China
YUAN Dan, E-mail: yuandanan0205@163.com.
ZHANG Shanyong, E-mail: zhangshanyong@126.com

Received date: 2023-04-07

  Accepted date: 2023-05-04

  Online published: 2023-07-11

Supported by

Program for Shanghai Outstanding Technology Research Leaders of Science and Technology Commission of Shanghai Municipality(21XD1431500);Three-Year Clinical Action Plan of Shanghai Hospital Development Center(SHDC2020CR3060B);Industry Support Fund of Huangpu District, Shanghai(XK2020013)

Fold

摘要

颞下颌关节（temporomandibular joint，TMJ）假体置换是关节重建的有效方法之一。与自体骨移植置换关节相比，人工关节置换具有无需开辟第二术区、手术时间短、即刻功能恢复等优势，目前已成为国际上关节重建的首选方案。其中定制型假体具有量身定制、去骨少等优势，然而中国尚无此类产品，因此研发一款国产化、定制型且符合中国人颌骨解剖特征的全TMJ假体十分重要。自2009年开始，笔者团队开始自主研发适合于中国人的全TMJ假体，历经3代假体的研发，已逐步实现了多孔钛合金与超高分子量聚乙烯（ultra-high molecular weight polyethylene，UHMWPE）的稳定连接，金属-非金属连接关节窝假体制造工艺日益成熟。2017年团队实现关键技术突破，采用搅拌摩擦焊接技术成功研发出第3代定制型全TMJ假体。国产定制型假体的相关力学性能已超过国际同类产品，其临床初步应用也取得了令人满意的短期随访结果。同时为了确保假体从设计加工到临床应用的高效性和精确性，笔者团队制定了一条较为成熟的标准化流程，并改进了假体植入手术。该文对国产定制型全TMJ假体系统近10余年的研发与应用进行了系统性的梳理和总结，并对未来国产假体的发展进行了展望。

关键词： 全颞下颌关节置换; 定制型假体; 中国制造; 搅拌摩擦焊接; 3D打印

本文引用格式

陈旭卓 , 毛懿 , 袁丹 , 张善勇 , 杨驰 . 国产定制型全颞下颌关节假体的研发与应用[J]. 上海交通大学学报（医学版）, 2023 , 43(5) : 524 -531 . DOI: 10.3969/j.issn.1674-8115.2023.05.002

Abstract

Alloplastic total joint replacement is one of the effective methods for temporomandibular joint (TMJ) reconstruction. As the first choice for TMJ reconstruction, alloplastic total joint replacement has the advantages of no need to open up a second operative area, short operation duration and immediate functional restoration, compared with autogenous bone graft. The customized prosthesis has the edge over the stock prosthesis due to its excellent suitability and less intraoperative bone trimming. However, there are no commercialized counterparts in China yet. Hence, it is urgent to develop a Chinese customized total TMJ prosthesis for Chinese patients. Since 2009, the authors′ team has begun to develop the customized total TMJ prostheses suitable for Chinese anatomical features independently. Through three generations of products, the team gradually realized the stable connection of porous titanium alloys and ultra-high molecular weight polyethylene (UHMWPE), and finally achieved a key technological breakthrough in 2017. The third generation of customized total TMJ prosthesis was successfully developed by friction stir welding technology. The mechanical properties of Chinese customized prostheses have prevailed over its international counterparts, with satisfactory short-term follow-up results based on its preliminary clinical application. Furthermore, in order to ensure high efficiency and accuracy of the procedures from design and manufacture to clinical application, the authors′ team has developed a relatively mature standardized process, and improved the surgical procedures. This review systematically summarizes the research and development of Chinese customized total TMJ prosthesis system in the past decade, and looks forward to the future development of Chinese customized prosthesis system.

Key words： total temporomandibular joint replacement; customized prosthesis; made in China; friction stir welding; 3D printing

参考文献

1 FRANCO R, BASILI M, VENDITTI A, et al. Statistical analysis of the frequency distribution of signs and symptoms of patients with temporomandibular disorders[J]. Oral Implantol (Rome), 2016, 9(4): 190-201.
2 LOTESTO A, MILORO M, MERCURI L G, et al. Status of alloplastic total temporomandibular joint replacement procedures performed by members of the American Society of Temporomandibular Joint Surgeons[J]. Int J Oral Maxillofac Surg, 2017, 46(1): 93-96.
3 GERBINO G, ZAVATTERO E, BOSCO G, et al. Temporomandibular joint reconstruction with stock and custom-made devices: indications and results of a 14-year experience[J]. J Craniomaxillofac Surg, 2017, 45(10): 1710-1715.
4 MERCURI L G. Costochondral graft versus total alloplastic joint for temporomandibular joint reconstruction[J]. Oral Maxillofac Surg Clin North Am, 2018, 30(3): 335-342.
5 WOLFORD L M, MERCURI L G, SCHNEIDERMAN E D, et al. Twenty-year follow-up study on a patient-fitted temporomandibular joint prosthesis: the Techmedica/TMJ Concepts device[J]. J Oral Maxillofac Surg, 2015, 73(5): 952-960.
6 ZWETYENGA N, AMROUN S, WAJSZCZAK B L, et al. Total temporomandibular joint prostheses[J]. Rev Stomatol Chir Maxillofac Chir Orale, 2016, 117(4): 285-293.
7 MERCURI L G. Alloplastic temporomandibular joint reconstruction[J]. Oral Surg Oral Med Oral Pathol Oral Radiol Endod, 1998, 85(6): 631-637.
8 CHRISTENSEN R W. The correction of mandibular ankylosis by arthroplasty and the insertion of a cast vitallium glenoid fossa: a new technique. A preliminary report of three cases[J]. Am J Orthop, 1963, 5: 16-24.
9 SAHA S, CAMPBELL C E, SARMA A, et al. A biomechanical evaluation of the Christensen temporomandibular joint implant[J]. Crit Rev Biomed Eng, 2000, 28(3-4): 399-403.
10 HOMSY C A, CAIN T E, KESSLER F B, et al. Porous implant systems for prosthesis stabilization[J]. Clin Orthop Relat Res, 1972, 89: 220-235.
11 KENT J N. An important lesson about biomaterials in the TMJ[J]. J Oral Maxillofac Surg, 1991, 49(4): 442-443.
12 MERCURI L G, WOLFORD L M, SANDERS B, et al. Long-term follow-up of the CAD/CAM patient fitted total temporomandibular joint reconstruction system[J]. J Oral Maxillofac Surg, 2002, 60(12): 1440-1448.
13 MERCURI L G, WOLFORD L M, SANDERS B, et al. Custom CAD/CAM total temporomandibular joint reconstruction system: preliminary multicenter report[J]. J Oral Maxillofac Surg, 1995, 53(2): 106-115, discussion 115-116.
14 LEANDRO L F, ONO H Y, LOUREIRO C C, et al. A ten-year experience and follow-up of three hundred patients fitted with the Biomet/Lorenz Microfixation TMJ replacement system[J]. Int J Oral Maxillofac Surg, 2013, 42(8): 1007-1013.
15 张晓虎, 杨驰, 陈敏洁, 等. 2例个体化人工关节用于颞下颌关节置换的初步效果评价[J]. 中国口腔颌面外科杂志, 2006, 4(6): 412-415.
15 ZHANG X H, YANG C, CHEN M J, et al. A primary application and evaluation of temporomandibular joint replacement with custom-made prosthesis[J]. China Journal of Oral and Maxillofacial Surgery, 2006, 4(6): 412-415.
16 张晓虎, 陈敏洁, 邱亚汀, 等. 标准型人工颞下颌关节置换术应用效果初步报告[J]. 上海口腔医学, 2012, 21(3): 298-302.
16 ZHANG X H, CHEN M J, QIU Y T, et al. A primary application and evaluation of temporomandibular joint replacement with stock prosthesis[J]. Shanghai Journal of Stomatology, 2012, 21(3): 298-302.
17 张晓虎, 陈敏洁, 邱亚汀, 等. 个体化人工颞下颌关节置换术远期疗效报告[J]. 中国口腔颌面外科杂志, 2010, 8(1): 26-29.
17 ZHANG X H, CHEN M J, QIU Y T, et al. A long-term clinical evaluation of temporomandibular joint replacement with custom-made prosthesis[J]. China Journal of Oral and Maxillofacial Surgery, 2010, 8(1): 26-29.
18 焦子先, 郑吉驷, 刘欢, 等. 成人颅下颌骨解剖测量分析[J]. 中国口腔颌面外科杂志, 2015, 13(2): 151-154.
18 JIAO Z X, ZHENG J S, LIU H, et al. The measurement data related to cranio-mandibular bones for research and development of total temporomandibular joint prosthesis[J]. China Journal of Oral and Maxillofacial Surgery, 2015, 13(2): 151-154.
19 ZHANG L Z, MENG S S, HE D M, et al. Three-dimensional measurement and cluster analysis for determining the size ranges of Chinese temporomandibular joint replacement prosthesis[J]. Medicine (Baltimore), 2016, 95(8): e2897.
20 DRIEMEL O, ACH T, MüLLER-RICHTER U D, et al. Historical development of alloplastic temporomandibular joint replacement before 1945[J]. Int J Oral Maxillofac Surg, 2009, 38(4): 301-307.
21 SHEN P, ZHANG S Y, YANG C, et al. The mandibular symmetry evaluation of total temporomandibular joint replacement on developing sheep[J]. J Craniomaxillofac Surg, 2014, 42(3): 201-205.
22 SHEN P, ZHANG S Y, YANG C, et al. Stability study of total temporomandibular joint replacement on sheep[J]. J Craniomaxillofac Surg, 2014, 42(7): 1265-1270.
23 CHEN X Z, WANG Y X, MAO Y, et al. Biomechanical evaluation of Chinese customized three-dimensionally printed total temporomandibular joint prostheses: a finite element analysis[J]. J Craniomaxillofac Surg, 2018, 46(9): 1561-1568.
24 郑吉驷, 张善勇, 杨驰, 等. 国产3D打印个性化全颞下颌关节的临床初步应用[J]. 上海交通大学学报(医学版), 2016, 36(9): 1287-1291.
24 ZHENG J S, ZHANG S Y, YANG C, et al. Clinical application of domestic customized 3D-printing total temporomandibular joint prostheses[J]. Journal of Shanghai Jiao Tong University (Medical Science), 2016, 36(9): 1287-1291.
25 ZHENG J S, CHEN X Z, JIANG W B, et al. An innovative total temporomandibular joint prosthesis with customized design and 3D printing additive fabrication: a prospective clinical study[J]. J Transl Med, 2019, 17(1): 4.
26 MERCURI L G. Alloplastic temporomandibular joint replacement: rationale for the use of custom devices[J]. Int J Oral Maxillofac Surg, 2012, 41(9): 1033-1040.
27 CHEN Y J, YUE T M, GUO Z N. Fatigue behaviour of titanium/PET joints formed by ultrasound-aided laser welding[J]. J Manuf Process, 2018, 31: 356-363.
28 LIU F, LIAO J, NAKATA K. Joining of metal to plastic using friction lap welding[J]. Mater Des, 2014, 54: 236-244.
29 WAGNER G, BALLE F, EIFLER D. Ultrasonic welding of aluminum alloys to fiber reinforced polymers[J]. Adv Eng Mater, 2013, 15(9): 792-803.
30 CHEN K, CHEN B X, ZHANG S Y, et al. Friction spot welding between porous TC4 titanium alloy and ultra high molecular weight polyethylene[J]. Mater Des, 2017, 132: 178-187.
31 ZOU X, JIANG M Y, CHEN K, et al. Mechanism of defect formation during friction spot joining of 3D-printed TC4 alloy and ultra-high molecular weight polyethylene[J]. Mater Des, 2020, 195: 108989.
32 ZHENG J S, LIU X H, CHEN X Z, et al. Customized skull base-temporomandibular joint combined prosthesis with 3D-printing fabrication for craniomaxillofacial reconstruction: a preliminary study[J]. Int J Oral Maxillofac Surg, 2019, 48(11): 1440-1447.
33 陈旭卓, 毛懿, 郑吉驷, 等. 国产个性化金属高分子一体式全颞下颌关节假体的临床初步应用[J]. 上海交通大学学报(医学版), 2019, 39(9): 1053-1059.
33 CHEN X Z, MAO Y, ZHENG J S, et al. Clinical application of Chinese customized TC4/UHMWPE connected total temporomandibular joint prostheses[J]. Journal of Shanghai Jiao Tong University (Medical Science), 2019, 39(9): 1053-1059.
34 CHEN X Z, MAO Y, ZHENG J S, et al. Clinical and radiological outcomes of Chinese customized three-dimensionally printed total temporomandibular joint prostheses: a prospective case series study[J]. J Plast Reconstr Aesthet Surg, 2021, 74(7): 1582-1593.
35 ZHENG J S, LIU X H, AHMED A, et al. Endoscopically assisted fixation of the custom-made total temporomandibular joint prosthesis in TMJ Yang′s system through a modified preauricular approach[J]. Int J Oral Maxillofac Surg, 2020, 49(2): 224-229.
Options
文章导航

/

〈 〉