球窝型人工腰椎间盘假体研究现状
doi: 10.7507/1001-5515.201909044
A review on the current state of ball-on-socket type artificial lumbar disc prosthesis
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摘要: 人工腰椎间盘置换术是治疗椎间盘退行性病变、缓解腰背痛的有效方式。球窝型人工腰椎间盘是最常用的假体类型。本文回顾了球窝型人工腰椎间盘假体的历史，综述了金属—聚合物、金属—金属和聚合物—聚合物不同组合配副的球窝型人工腰椎间盘假体产品现状。结合最新研究进展，分析球窝型人工腰椎间盘假体结构设计因素及影响，并对球窝型人工腰椎间盘假体未来的发展加以展望，以期为设计球窝型人工腰椎间盘假体提供更加全面系统的理论参考。Abstract: Total lumbar disc replacement is an alternative to interbody fusion for the effective treatment of symptomatic degenerative disc disease. This paper reviewed the history of ball-on-socket type artificial lumbar disc (ALD) prosthesis, which is a typical ALD prosthesis and summarized the ALD prosthesis research progress, according to different materials such as metal-on-metal, metal-on-polymer, and polymer-on-polymer prosthesis. The structural design factors of ball-on-socket type ALD prosthesis were analyzed and its prospect of development was also presented. The purpose of this paper is to provide a theoretical reference for the design of the ball-on-socket ALD prosthesis by reviewing the current state of ball-on-socket type ALD prosthesis.
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Key words:
- artificial lumbar disc /
- ball-on-socket /
- prosthesis /
- current state
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图 1 人工腰椎间盘假体尺寸标注示意图
Figure 1. Size labeling schematic diagram of artificial lumbar disc prosthesis
表 1 人工腰椎间盘假体产品现状
Table 1. Artificial lumbar disc prosthesis product status
配副 材料 产品 制造商 自由度 关节面 球窝位置 形状 状态 MoP CoCr-UHMWPE Charité DePuy Synthes Spine，Raynham，MA，USA 5 移动 中间 椭圆形 FDA 批准-2004 ProDisc-L DePuy Synthes Spine，Raynham，MA，USA 3 固定 中间 D 字形 FDA 批准-2006 Activ-L Aesculap AG，Tuttlingen，Germany 4 移动 中间 D 字形 FDA 批准-2015 Mobidisc-L Zimmer Biomet，Warsaw，IN，USA 5 移动 中间 椭圆形 — Ti-PE Baguera-L SpineArt，Geneva，Switzerland 4 或 6 可选 中间 D 字形 未被 FDA 批准 MoM CoCr-CoCr Maverick Medtronic，Memphis，TN，USA 3 固定 后置 D 字形 IDE 试验完成 Flexicore Stryker Spine，Allendale，NJ，USA 3 限制 中间 D 字形 — Kineflex Southern Medical（Pty）Ltd.，Irene，South Africa 5 移动 后置 椭圆形 IDE 试验终止 XL TDR NuVasive，Inc.，San Diego，CA，USA 3 固定 后置 长方形 IDE 试验阶段 TRIUMPH Globus Medical，Inc.，Audubon，PA，USA 3 固定 后置 长方形 IDE 试验阶段 PoP PEEK-PEEK InOrbitTM Globus Medical，Inc.，Audubon，PA，USA 3 固定 中间 长方形 — ORBITTM-R Globus Medical，Inc.，Audubon，PA，USA 3 移动 中间 椭圆形 — 注：IDE：医疗器械研究性试验豁免（investigational device exemption）；PEEK：聚醚醚酮（polyetheretherketone） 
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表 2 CoCr-UHMWPE 材料配副假体不同的髓核固定方式
Table 2. Different ways on core fixation of CoCr-UHMWPE type prosthesis
产品 UHMWPE 髓核与 CoCr 合金的相对运动 Charité 髓核自由旋转和滑动 ProDisc-L 髓核完全固定在下终板 Activ-L 髓核固定在下终板上，且前后方向可微小移动 Mobidisc-L 髓核固定在下终板上，且前后左右方向均可微小移动
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表 3 不同材料配副的优缺点
Table 3. Advantages and disadvantages of different material pairings
种类 优点 缺点 MoP 聚合物髓核可以起到缓冲吸振作用 聚合物力学性能不足，易破碎。同时聚合物磨屑会导致
骨溶解MoM 金属的磨损性能好，磨损率低，采用后置旋转中心，可以减小
小关节应力金属离子可引起过敏毒性等反应 PoP 聚合物弹性模量低，缓冲吸振 同 MoP 配副
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表 4 人工腰椎间盘假体产品设计尺寸规格
Table 4. Design sizes of artificial lumbar disc prosthesis products
产品 高度/mm 角度/（°） 型号 长 × 宽/（mm × mm） ProDisc-L H1 = 10，12，14 3，6，9，11 M，L 34.5 × 27，39 × 30 Activ-L H2 = 8.5，10，12，14 6，11，16 S，M，L，XL 31 × 26，34.5 × 28，39 × 30，40 × 33 Mobidisc-L H1 = 10，11，12，13 5，10 T6，T8（S，M，L） 34 × （27，30，33），39 × （30，33，36） Baguera-L h = 8，10，12 5，10 S，M，L 35 × 27，39 × 30，42 × 31 Maverick H1 = 10，12，14 6，9，12 S，M，L 32 × 25，35 × 27，39 × 30
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表 5 人工腰椎间盘假体产品表面生物涂层和固定方式
Table 5. Biological coatings and fixation methods of artificial lumbar disc prosthesis products
产品 表面生物涂层 固定方式 ProDisc-L 多孔钛 上下 2 个脊骨 Activ-L 等离子体钛微孔涂层和微米级磷酸钙层 上下共 6 个尖齿 Mobidisc-L 粗糙钛表面和羟基磷灰石涂层 上下 2 个固定嵌片 Baguera-L 多孔钛 上下共 10 个尖齿 Maverick 羟基磷灰石涂层 上下 2 个脊骨
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