国产定制型全颞下颌关节假体的研发与应用

doi:10.3969/j.issn.1674-8115.2023.05.002

上海交通大学学报（医学版） ›› 2023, Vol. 43 ›› Issue (5): 524-531.doi: 10.3969/j.issn.1674-8115.2023.05.002

• 口腔外科专题 • 上一篇

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

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

收稿日期:2023-04-07 接受日期:2023-05-04 出版日期:2023-05-28 发布日期:2023-07-11
通讯作者: 袁丹,张善勇 E-mail:cxzzxcaa@126.com;yuandanan0205@163.com;zhangshanyong@126.com
作者简介:陈旭卓（1994—），男，住院医师，博士；电子信箱：cxzzxcaa@126.com。
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)

Development and application of Chinese customized total temporomandibular joint prosthesis

CHEN Xuzhuo(), MAO Yi, YUAN Dan(), ZHANG Shanyong(), YANG Chi

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

Received:2023-04-07 Accepted:2023-05-04 Online:2023-05-28 Published:2023-07-11
Contact: YUAN Dan,ZHANG Shanyong E-mail:cxzzxcaa@126.com;yuandanan0205@163.com;zhangshanyong@126.com
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)

摘要/Abstract

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

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

中图分类号:

R782.1

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.

CHEN Xuzhuo, MAO Yi, YUAN Dan, ZHANG Shanyong, YANG Chi. Development and application of Chinese customized total temporomandibular joint prosthesis[J]. Journal of Shanghai Jiao Tong University (Medical Science), 2023, 43(5): 524-531.

图/表 4

图1 国产定制型全TMJ假体系统的发展历程Note： A. The first generation of trial product. B. The second generation of prosthesis, and the fossa was totally made of UHMWPE. C. The third generation of TC4-UHMWPE-connected fossa prosthesis. D. Clinical implantation of the third generation of prosthesis.

Fig 1 Development of Chinese customized total TMJ prosthesis system

图2 第3代国产定制型全TMJ假体制作及临床应用的标准化流程

Fig 2 Standardized workflow for manufacture and clinical application of the third generation of Chinese customized total TMJ prostheses

图3 第3代国产定制型全TMJ假体植入手术方法的改进Note： A. Fixation of the mandibular prosthesis assisted by endoscopy. B. The dead space filled with buccal fat pads. C. Zygomatic arch osteotomy and prosthesis positioning guided by digital templates. D. Mandibular osteotomy and prosthesis position guided by digital templates.

Fig 3 Surgical improvements for the third generation of Chinese customized total TMJ prostheses

表1 第3代国产定制型全TMJ假体与TMJ Concepts定制型假体的对比

Tab 1 Comparison between the third generation of Chinese customized total TMJ prosthesis and customized TMJ Concepts prosthesis

Type

Designing and manufacture

Technology for fossa component connection

General procedure

Price

TMJ Concepts

Wax-up and rapid machining with prolonged period of designing and manufacture

Melting connection with the maximum connected force of

1 725 N

Repetitive confirmation for wax-up and prosthesis, which takes 7 to 8 weeks to get the final product

150 000 yuan per side

Chinese customized prosthesis

Utilization of virtual surgical planning,

3D printing and CAD/CAM with reduced period of designing and manufacture

Friction stir welding with the maximum connected force of

5 020 N

Chinese customized prosthesis was designed and

approved in a totally digital approach, which takes 3 to 4 weeks to get the final product

Expected 50 000 yuan per side

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国产定制型全颞下颌关节假体的研发与应用

Development and application of Chinese customized total temporomandibular joint prosthesis

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