CN102319129B - 融合假体 - Google Patents

融合假体 Download PDF

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Publication number
CN102319129B
CN102319129B CN201110326485.XA CN201110326485A CN102319129B CN 102319129 B CN102319129 B CN 102319129B CN 201110326485 A CN201110326485 A CN 201110326485A CN 102319129 B CN102319129 B CN 102319129B
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CN
China
Prior art keywords
prosthese
fusion
dentata
bone
bone structure
Prior art date
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Application number
CN201110326485.XA
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English (en)
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CN102319129A (zh
Inventor
刘忠军
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Beijing Aikang Yicheng Medical Equipment Co., Ltd.
Original Assignee
Beijing AK Medical Co Ltd
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Priority to CN201110326485.XA priority Critical patent/CN102319129B/zh
Publication of CN102319129A publication Critical patent/CN102319129A/zh
Priority to EP12844108.6A priority patent/EP2772230B1/en
Priority to PCT/CN2012/078528 priority patent/WO2013060168A1/zh
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Publication of CN102319129B publication Critical patent/CN102319129B/zh
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/4455—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
    • A61F2/4465—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages having a circular or kidney shaped cross-section substantially perpendicular to the axis of the spine
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    • A61F2310/00796—Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
    • F04C—ROTARY-PISTON, OR OSCILLATING-PISTON, POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; ROTARY-PISTON, OR OSCILLATING-PISTON, POSITIVE-DISPLACEMENT PUMPS
    • F04C2270/00—Control; Monitoring or safety arrangements
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    • F04C2270/041—Controlled or regulated

Abstract

本发明提供了一种融合假体，设置在第一骨结构和第二骨结构之间以替代第一骨结构和第二骨结构之间的骨结构，融合假体包括假体主体和设置在假体主体上的假体融合面，假体融合面与第一骨结构和第二骨结构之中的至少一个相贴合，假体融合面的表面为微孔结构。假体主体是根据患者的CT/MRI/UCT等断层扫描数据制作的等尺寸金属植入物，假体融合面依据被替代的骨结构建造并与第一骨结构以及第二骨结构之中的至少一个良好吻合，假体融合面表面的微孔结构有利于骨细胞爬行长入，术后融合假体的假体融合面将与第一骨结构和第二骨结构之中的至少一个的骨关节面发生骨融合以达到远期稳定。

Description

融合假体
技术领域
本发明涉及骨科植入领域，更具体地，涉及一种融合假体。
背景技术
脊柱是人体的中轴支柱，上部与颅骨底部的枕骨相连、下部直达尾骨末端。脊柱由椎骨、骶骨和尾骨借助椎间盘、椎间关节及诸多韧带连接，是躯干的活动中心和力学传递的枢纽，承担着支持体重、减震、保护中枢神经系统、提供身体上半部分的前后伸屈、侧弯、扭转等运动功能。由于现代人类生活方式的变化，生活节奏的加快，导致脊柱即周围组织的负载加剧，损伤机会大为增加，脊柱发病的几率不断上升。常见的脊柱疾病如创伤、肿瘤、先天畸形、结核、类风湿关节炎等等病变所导致的脊椎椎体损伤及缺失时有发生，当前解决椎体缺失的办法主要有植骨填充、人工椎体置换等方法，并辅之以前路或后路的钉板、钉棒内固定。
但现有技术存在的问题是人工椎体与上下相邻节段的生理椎体之间需要持续的压力以保持紧密接触防止植入物与相邻椎体间移位滑脱，因此必须另行植入一套保持压力的刚性的钉板或钉棒系统，而这一类的固定系统通常会高出原有生理椎体表面而对周围神经、血运和软组织带来不利影响；另外刚性固定系统与生理骨质的弹性模量差异过大且无法融合成一体，因此远期容易产生疲劳断裂。
特别需要指出的是某些特定阶段的椎体关节例如寰枢关节，寰枢关节是连接颅骨与脊柱的非常特殊而重要的脊椎结构，由于其所处部位及其解剖结构极其特殊，一旦由于病变造成枢椎缺失时常规颈椎人工椎体无法适用，目前尚没有针对性的假体植入替代方案，临床中只能由医生根据具体情况临时采用改造钛笼或钛网的办法加之自体或异体骨进行植骨融合，且术后需要较长时间的头颈肩部固定直至完全融合，给病人的生活带来极大不便。
发明内容
本发明目的在于提供一种能够替代人体的骨结构从而可以植入人体的融合假体。
根据本发明的融合假体，设置在第一骨结构和第二骨结构之间以替代第一骨结构和第二骨结构之间的骨结构，融合假体包括假体主体和设置在假体主体上的假体融合面，假体融合面与第一骨结构和第二骨结构之中的至少一个相贴合，假体融合面的表面具有微孔结构。
进一步地，微孔结构为包括多个相互连通的微孔隙的多向微孔隙结构。
进一步地，微孔结构的孔隙的孔径为100μm至1800μm。
进一步地，融合假体为枢椎融合假体，用于替代寰椎与第三颈椎之间的枢椎，假体融合面包括设置在假体主体上端并与寰椎相贴合的上关节融合面。
进一步地，枢椎融合假体在植入人体后其正前方表面位于原枢椎正前方生理表面以内。
进一步地，假体主体上设置有多个倾斜并向上延伸的第三连接孔，枢椎融合假体通过固定件分别与寰椎和第三颈椎相连接。
进一步地，假体主体的上关节融合面上对应原枢椎的齿突位置处设置有齿突凸台。
进一步地，假体主体的上端对应于寰椎的寰椎前弓外侧的侧块的位置设置有立面板，立面板与齿突凸台一起形成对寰椎前弓的夹持。
进一步地，立面板为两个并分别对应于寰椎前弓外侧的左右两个侧块，立面板上分别设置有第一连接孔。
进一步地，假体融合面还包括设置在假体主体下端并与第三颈椎相贴合的下关节融合面。
进一步地，下关节融合面上设置有一个或者多个第二连接孔。
进一步地，假体主体的表面和/或内部设置有加强部。
进一步地，融合假体设置在寰椎与第三颈椎之间以替代枢椎，融合假体植入人体后其总体占位高度与原生理枢椎关节一致或者向下延伸加长以替代枢椎和第三颈椎或者替代更多颈椎椎体节段。
进一步地，假体主体为微孔结构。
进一步地，假体主体上设置有多个植骨孔，多个植骨孔之间相互贯通或者通过微孔结构相连通。
进一步地，植骨孔的孔径为2mm至30mm。
采用本发明的融合假体，其假体主体是根据患者的CT/MRI/UCT等断层扫描数据制作的等尺寸金属植入物，该融合假体的上设有假体融合面，假体融合面依据被替代的骨结构建造并与第一骨结构以及第二骨结构之中的至少一个良好吻合，假体融合面表面为便于骨细胞长入的微孔结构，该微孔结构是一种相互连通的多向微孔隙结构，该孔隙有利于骨细胞爬行长入，术后融合假体的假体融合面将与第一骨结构和第二骨结构之中的至少一个的骨关节面发生骨融合以达到远期稳定。
附图说明
构成本申请的一部分的附图用来提供对本发明的进一步理解，本发明的示意性实施例及其说明用于解释本发明，并不构成对本发明的不当限定。在附图中：
图1是根据本发明的融合假体的立体结构示意图；
图2是根据本发明的融合假体的微孔结构示意图；
图3是根据本发明的融合假体与枢椎的连接以及分解结构示意图；
图4是根据本发明的融合假体与枢椎的通过螺钉连接的结构示意图；
图5是根据本发明的融合假体与螺钉的分解结构示意图；
图6是根据本发明的融合假体的植骨孔的结构示意图；
图7是根据本发明的融合假体的延伸加长实施例的结构示意图；以及
图8是根据本发明的融合假体的延伸加长实施例的应用状态的结构示意图。
具体实施方式
下面将参考附图并结合实施例来详细说明本发明。
如图1所示的根据本发明的融合假体，设置在第一骨结构2和第二骨结构3之间以替代第一骨结构2和第二骨结构3之间的骨结构，融合假体包括假体主体10和设置在假体主体10上的假体融合面，假体融合面与第一骨结构2和第二骨结构3之中的至少一个相贴合，假体融合面的表面为微孔结构，微孔结构为多个相互连通的多向微孔隙结构。
采用本发明的融合假体1，其假体主体10是根据患者的CT/MRI/UCT等断层扫描数据制作的等尺寸医用金属植入物，融合假体1由医用金属制成，因此其具有良好生物相容性。该融合假体1的上设有假体融合面，假体融合面依据被替代的骨结构建造并与第一骨结构2以及第二骨结构3之中的至少一个良好吻合，假体融合面表面为便于骨细胞长入的微孔结构30，微孔结构30的孔隙的直径为100μm至1800μm。如图2所示，该微孔结构是一种相互连通的多向微孔隙结构，该孔隙有利于骨细胞爬行长入，术后融合假体的假体融合面将与第一骨结构和第二骨结构之中的至少一个的骨关节面发生骨融合以达到远期稳定。优选地，融合假体1的两端均具有分别与第一骨结构2和第二骨结构3相贴合的假体融合面。
优选地，假体主体10为医用金属制成微孔结构，该微孔结构的表面及内部孔隙相互贯通，微孔结构的孔隙孔径100μm至1800μm。
如图3所示，根据本发明的融合假体1为枢椎融合假体，设置在寰椎2与第三颈椎3之间以替代枢椎，假体融合面包括设置在假体主体10上端并与寰椎相贴合的上关节融合面20。优选地，假体融合面还包括设置在假体主体10下端并与第三颈椎相贴合的下关节融合面60。
出于手术入路的需要，枢椎融合假体可不保留横突、棘突、椎弓结构，除必要的功能性设计改变外，该枢椎融合假体在尺寸上与患者原生理枢椎椎体保持基本一致。枢椎融合假体上下两端分别设有上关节融合面20和下关节融合面60，上关节融合面20和下关节融合面60是分别提取寰椎下关节面和第三颈椎上关节面的曲面数据后由数控机床加工，也可以利用激光烧结或高能电子束熔融等快速成型技术建造具有曲面高度拟合特性的表面，枢椎融合假体的上关节融合面20依据寰椎下关节面数据建造并与寰椎下关节面良好吻合，枢椎融合假体的下关节融合面60依据第三颈椎上关节面数据建造并与第三颈椎上关节面良好吻合。由于上关节融合面20和下关节融合面60的表面均为微孔结构，手术后枢椎融合假体的上关节融合面20和下关节融合面60将分别与寰椎和第三颈椎的骨关节面发生骨融合以达到远期稳定。
如图1所示，根据枢椎融合假体的一个实施例，假体主体10的上关节融合面20上对应原枢椎的齿突位置处设置有齿突凸台40。假体主体10的上端对应于寰椎的寰椎前弓外侧的侧块的位置设置有立面板50，用于与齿突凸台40一起形成对寰椎前弓的夹持。优选地，立面板50为两个并分别对应于寰椎前弓外侧的左右两个侧块，立面板50上分别设置有第一连接孔51。
齿突凸台40外表面以及立面板50内侧与寰椎侧块接触的内表面均为便于骨细胞长入的微孔结构，该微孔结构是一种相互连通的多向微孔隙结构，孔隙直径为100μm～1800μm，该孔隙有利于骨细胞爬行长入，手术后齿突凸台40将与寰椎前弓内侧的寰椎齿突凹发生骨融合、立面板50内表面的微孔结构将与寰椎侧块发生骨融合，从而使得融合假体与寰椎相结合并达到远期稳定。如图4和图5所示，手术中将连接件90分别由两个第一连接孔51中旋入寰椎侧块以达到初始稳定的目的，待骨融合完成后即可达到颈椎稳定的重建。在本实施例中，连接件90为固定螺钉。
根据枢椎融合假体的另一个实施例，如图5所示，所述枢椎融合假体在植入人体后其正前方表面位于原枢椎正前方生理表面以内。
在本实施例中，枢椎融合假体上端对应于寰椎前弓下缘处设置有凹槽并与寰椎前弓下缘良好嵌合，假体主体10上设置有多个倾斜并向上延伸的第三连接孔62，枢椎融合假体通过固定件90分别与寰椎和第三颈椎相连接。具体地，第三连接孔62为螺钉孔，固定件90为固定螺钉。枢椎融合假体对应于寰椎前弓外侧左右两个侧块位置的下方各自设有一个螺钉孔，手术中将固定螺钉分别由两个螺钉孔旋入寰椎侧块以达到初始稳定的目的。枢椎融合假体的假体主体10上端的对应于寰椎前弓下缘处的凹槽与寰椎下缘接触的部位的凹槽表面为微孔结构，该微孔结构是一种相互连通的多向微孔隙结构，孔隙直径为100μm至1800μm，该孔隙有利于骨细胞爬行长入，术后枢椎融合假体的假体主体10上端对应于寰椎前弓下缘处的凹槽内表面的微孔结构将与寰椎前弓下缘发生骨融合以达到远期稳定。
在本实施例中，枢椎融合假体在植入人体后其正前方表面位于原枢椎正前方生理表面以内，即枢椎融合假体在植入后其正前方表面不突出于原枢椎正前方生理表面，也即达到医学界所说的零切迹，因此对枢椎前方各种软组织解剖位置无任何不良影响。
如图1所示，下关节融合面60上设置有一个或者多个第二连接孔61。
根据本发明的一个实施例，假体主体10下端对应于第三颈椎上关节面的假体融合面为便于骨细胞长入的微孔结构，该孔隙有利于骨细胞爬行长入，术后枢椎融合假体下端对应于第三颈椎上关节面的假体融合面将与第三颈椎上关节面发生骨融合以达到远期稳定。枢椎融合假体下端对应于第三颈椎上关节面的假体融合面上设有1至3个螺钉孔。如图4和图5所示，手术中将固定螺钉90分别由第二连接孔61中旋入第三颈椎上关节面以达到初始稳定的目的，待骨融合完成后即可达到颈椎稳定的重建。
如图6和图7所示，假体主体10上设置有多个植骨孔80，多个植骨孔80之间相互贯通或者通过微孔结构相连通。
在枢椎融合假体主体上设有若干植骨孔80，该植骨孔80可以容纳自体或异体骨块和骨颗粒，术前或术中在该植骨孔80内植入自体或异体骨块和骨颗粒可以起到诱导骨细胞爬行长入促进骨融合的作用，植骨孔孔径为2mm至30mm，以方便不同直径的自体或异体骨块和骨颗粒植入。
前述融合假体的主体表面和/或内部的全部或局部涂敷有羟基磷灰石涂层，该羟基磷灰石涂层采用等离子喷涂法或电化学沉积法以及烧结法形成。
另外，枢椎融合假体设置在寰椎与第三颈椎之间以替代枢椎，融合假体植入人体后其总体占位高度与原生理枢椎关节一致。
假体主体10的表面和/或内部设置有加强部，加强部为加强筋或加强板，以强化假体主体10的结构强度。
如图7和图8所示，当患者枢椎及第三颈椎或更多颈椎阶段均需要由假体替代时，融合假体向下延伸加长以涵盖替代第三颈椎4直至更多的颈椎椎体节段，此时融合假体将与第四或其他节段颈椎椎体衔接固定，其固定融合方式与上述与第三颈椎对接固定的方式相同。
枢椎融合假体的加工方法是：获得患者颈椎部位CT/MRI/UCT等断层扫描数据→在计算机中建立颈椎病变部位的三维数据模型→提取枢椎模型并进行修改设计生成枢椎融合假体三维数据模型→用枢椎融合假体三维数据模型模拟替代生理枢椎以检查并验证设计方案→加工成型。
根据目前的加工技术有两条较理想的加工路径：
A、采用数控加工机床依据在计算机中生成的枢椎融合假体数据转换成的加工程序进行加工成型，然后使用电火花加工、化学腐蚀、机械钻孔切削等方法加工钻铣出所需要的植骨孔、螺钉孔与微孔，固定螺钉则采用车削或铣等常规机械加工方法制作；
B、利用激光烧结或高能电子束熔融等快速成型技术熔融成型，具体方法如下：
a)使用专业软件对在计算机中设计建造的枢椎融合假体三维数据模型进行分层，以获得一系列单层切片的轮廓数据；
b)向激光或高能电子束快速成型设备输入上述系列层片数据；
c)在激光或高能电子束快速成型设备加工舱内铺设与前述三维数据模型分层时层高相应厚度的医用金属粉末；
d)由计算机控制激光束或高能电子束对医用金属粉末进行扫描并有选择的熔化；
e)重复前述铺设粉末、扫描熔化步骤以使各层被选择熔化的材料相互熔结成整体；
f)完成全部层面的熔融过程后去除未熔融的粉末即可得到所需要形状结构的枢椎融合假体；
g)由于在建造枢椎融合假体三维数据模型时已经将所需要的实体、植骨孔、螺钉孔、微孔等等结构一并设计在数据文件中，因此上述各种结构在激光烧结或高能电子束熔融过程中将一次性完成制造。
从以上的描述中，可以看出，本发明上述的实施例实现了如下技术效果：
本发明的融合假体，假体融合面表面为便于骨细胞长入的微孔结构，该微孔结构是一种相互连通的多向微孔隙结构，该孔隙有利于骨细胞爬行长入，术后融合假体的假体融合面将与第一骨结构和第二骨结构之中的至少一个的骨关节面发生骨融合以达到远期稳定。
以上所述仅为本发明的优选实施例而已，并不用于限制本发明，对于本领域的技术人员来说，本发明可以有各种更改和变化。凡在本发明的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。

Claims (13)

1.一种融合假体，设置在第一骨结构（2）和第二骨结构（3）之间以替代所述第一骨结构（2）和所述第二骨结构（3）之间的骨结构，其特征在于，所述融合假体包括假体主体（10）和设置在所述假体主体（10）上的假体融合面，所述假体融合面与所述第一骨结构（2）和所述第二骨结构（3）之中的至少一个相贴合，所述假体融合面具有微孔结构，所述微孔结构为包括多个相互连通的微孔隙的多向微孔隙结构，所述融合假体为枢椎融合假体，用于替代寰椎与第三颈椎之间的枢椎，所述假体融合面包括设置在所述假体主体（10）上端并与所述寰椎相贴合的上关节融合面（20），所述假体主体（10）的上关节融合面（20）上对应原枢椎的齿突位置处设置有齿突凸台（40）。
2.根据权利要求1所述的融合假体，其特征在于，所述微孔结构（30）的孔隙的孔径为100μm至1800μm。
3.根据权利要求1所述的融合假体，其特征在于，所述枢椎融合假体在植入人体后其正前方表面位于原枢椎正前方生理表面以内。
4.根据权利要求3所述的融合假体，其特征在于，所述假体主体（10）上设置有多个倾斜并向上延伸的第三连接孔（62），所述枢椎融合假体通过固定件（90）分别与寰椎和第三颈椎相连接。
5.根据权利要求1所述的融合假体，其特征在于，所述假体主体（10）的上端对应于所述寰椎的寰椎前弓外侧的侧块的位置设置有立面板（50），所述立面板（50）与所述齿突凸台（40）一起形成对所述寰椎前弓的夹持。
6.根据权利要求5所述的融合假体，其特征在于，所述立面板（50）为两个并分别对应于所述寰椎前弓外侧的左右两个侧块，所述立面板（50）上分别设置有第一连接孔（51）。
7.根据权利要求1所述的融合假体，其特征在于，所述假体融合面还包括设置在所述假体主体（10）下端并与所述第三颈椎相贴合的下关节融合面（60）。
8.根据权利要求7所述的融合假体，其特征在于，所述下关节融合面（60）上设置有一个或者多个第二连接孔（61）。
9.根据权利要求1所述的融合假体，其特征在于，所述假体主体（10）的表面和/或内部设置有加强部。
10.根据权利要求1所述的融合假体，其特征在于，所述融合假体设置在寰椎与第三颈椎之间以替代枢椎，所述融合假体植入人体后其总体占位高度与原生理枢椎关节一致或者向下延伸加长以替代枢椎和第三颈椎或者替代更多颈椎椎体节段。
11.根据权利要求1至10中任一项所述的融合假体，其特征在于，所述假体主体（10）为微孔结构。
12.根据权利要求11所述的融合假体，其特征在于，所述假体主体（10）上设置有多个植骨孔（80），多个所述植骨孔（80）之间相互贯通或者通过所述微孔结构相连通。
13.根据权利要求12所述的融合假体，其特征在于，所述植骨孔（80）的孔径为2mm至30mm。
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