CN105853031B - 一种仿生防脱位人工腰椎及椎间盘连接复合体 - Google Patents

一种仿生防脱位人工腰椎及椎间盘连接复合体 Download PDF

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Publication number
CN105853031B
CN105853031B CN201610285603.XA CN201610285603A CN105853031B CN 105853031 B CN105853031 B CN 105853031B CN 201610285603 A CN201610285603 A CN 201610285603A CN 105853031 B CN105853031 B CN 105853031B
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China
Prior art keywords
arc
bottom plate
lumbar vertebrae
cylindroid
disc
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CN105853031A (zh
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贺西京
刘俭涛
张峰
贺高乐
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Shaanxi Zhongyi Weikang Medical Equipment Co ltd
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Second Affiliated Hospital School of Medicine of Xian Jiaotong University
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Priority to CN201610285603.XA priority Critical patent/CN105853031B/zh
Publication of CN105853031A publication Critical patent/CN105853031A/zh
Priority to PCT/CN2016/108539 priority patent/WO2017185754A1/zh
Priority to US15/762,833 priority patent/US10751194B2/en
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    • A61F2/30771Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30841Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30904Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves serrated profile, i.e. saw-toothed
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/44Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/442Intervertebral or spinal discs, e.g. resilient
    • A61F2/4425Intervertebral or spinal discs, e.g. resilient made of articulated components
    • A61F2002/443Intervertebral or spinal discs, e.g. resilient made of articulated components having two transversal endplates and at least one intermediate component
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005The prosthesis being constructed from a particular material
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005The prosthesis being constructed from a particular material
    • A61F2310/00011Metals or alloys
    • A61F2310/00023Titanium or titanium-based alloys, e.g. Ti-Ni alloys
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00389The prosthesis being coated or covered with a particular material
    • A61F2310/00592Coating or prosthesis-covering structure made of ceramics or of ceramic-like compounds
    • A61F2310/00796Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite

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Abstract

本发明公开了一种仿生防脱位人工腰椎及椎间盘连接复合体,包括椎体部件、椎间盘部件及螺钉。椎体部件由上下两面带有深凹槽的椭圆柱体构成,椎间盘部件包括弧形L板和复合材料垫,弧形L板由底板、弧形侧板与圆柱状突起构成,圆柱状突起末端为带有两个弧形突起的近半球壳结构,复合材料垫与椭圆柱体深凹槽相连接,近半球壳结构与复合材料垫内的大半球体结构相配合构成防脱球窝关节,本发明不但可以替代腰椎手术中取掉的椎体及邻近的椎间盘,而且保留了椎间盘的旋转、屈伸及一定的缓冲功能,并且整个结构设有防脱装置,既保证了术后的稳定性,又保留了腰椎的活动性,在仿生学上更接近人体生理状态。

Description

一种仿生防脱位人工腰椎及椎间盘连接复合体
技术领域
本发明属于医用假体制造技术领域,尤其涉及腰椎椎体及邻近椎间盘病变切除术后进行假体移植,可以保留腰椎活动功能的仿生防脱位人工腰椎及椎间盘连接复合体。
背景技术
腰椎位于人体脊柱的下段,椎体较大,上下终板呈肾型,终板中央偏后处略凹陷,椎体与椎体之间通过前宽后窄的椎间盘相连接,形成生理弯曲,是人体重要的承重器官。在正常人体中,因椎间盘的作用,椎体有一定旋转、侧弯、前屈、背伸功能,有研究报道20-30岁正常国人腰椎节段(L1/L2—L5/S1)屈伸活动度范围(Overlay法):男性为14.15°~29.39°,女性为14.54°~26.61°。
腰椎结核、肿瘤、陈旧性骨折常导致脊柱侧弯、脊髓压迫等严重并发症,是严重威胁人体健康的一类疾病。目前,针对上述疾患通常采取病灶清除术后行钛笼植骨融合联合钉棒内固定治疗,手术入路分为单纯前路、单纯后路及前后联合入路。因该术式能够获得即刻及长期稳定性,被脊柱外科医生广泛采用。但是该手术一般至少融合三个邻近椎体,被融合椎体丧失了正常的活动功能,导致未融合节段应力集中及活动范围增加,长期可导致邻近椎间盘退变、继发性椎管狭窄、关节突关节退变、获得性脊椎滑脱、不稳等严重并发症。此外,有学者长期随访发现进行钛笼植骨融合的患者可能存在钛笼沉降等并发症,病情严重者需再次手术治疗。
为克服钛笼缺陷,人工椎体的改进一直备受关注,目前已由最初的单纯撑开型,发展到撑开固定型、可调固定型以及自固定型,制作材料也由原来的金属材质,发展到现在的陶瓷、高分子复合材料等多种材料并存。尽管人工椎体的发展使术后稳定性有所增加,个别假体甚至除去了钉棒***的固定,减少了手术创伤,但因上述假体仍以融合固定为主,无法保留正常椎体的活动功能,因此仍无法避免融合固定后可能引起的并发症。虽然有学者研制出具有一定活动功能的人工椎体,但是该假体的活动中心位于椎体中央,远离椎间隙,而且活动范围较小,与脊柱的正常生理状态不符,长期可能会导致小关节突磨损、钙化及难以预料的潜在并发症,因此未得到广泛应用。
为保留椎体的活动功能,国内外众多学者致力于人工椎间盘的研究,目前市场上有多种人工椎间盘被应用于治疗颈、腰椎椎间盘病变,其中SB Charité Disc与Prodisc II在治疗腰椎病变中被广泛应用,在一项前瞻性随机对照研究中SB Charité Disc植入相对于植骨融合等内固定术在治疗腰背痛方面取得了更好的效果。但是有研究报道椎间盘植入后存在假体移位、脱落导致临近血管、神经的损伤,而且对于多阶段人工椎间盘植入可能造成脊柱不稳,对于存在合并椎体病变的患者,人工椎间盘将难以植入。
为解决上述难题,国内贺西京、雷伟等教授首次着力于人工椎体及椎间盘***的研究,目前在颈椎方面已取得了可喜的成绩,仿生寰枢椎假体及下颈椎的人工椎体及椎间盘复合体在动物实验中取得了比较满意的效果。但是因腰椎解剖结构及生理功能的复杂,颈椎的人工椎体及椎间盘复合体难以应用于腰椎。人工腰椎及椎间盘连接复合体必需满足以下三点:1.保证植入后脊柱的即刻及长期稳定性。2.保留邻近椎体的运动功能。3.满足正常脊柱的承重功能。但是目前人工假体、人工椎间盘及下颈椎的人工椎体及椎间盘***均难以做到,查阅国内外相关文献亦未发现有关人工腰椎及椎间盘连接复合体的报道。
发明内容
本发明的目的在于克服传统融合技术的缺点,充分吸取目前人工椎间盘及人工椎体的优势,取长补短,提供一种仿生防脱位人工腰椎及椎间盘连接复合体。
为达到上述目的,本发明采用了以下技术方案:
该人工腰椎及椎间盘连接复合体包括椎体部件以及设置于椎体部件两端的椎间盘部件,所述椎间盘部件包括弧形L板以及复合材料垫,所述弧形L板包括分别与腰椎椎体的终板以及侧面形状相应的底板以及侧板,所述侧板设置于所述底板上,所述底板与复合材料垫之间通过球窝关节相连,所述椎体部件包括椭圆柱体,椭圆柱体的两个端面上开设有凹槽,两个椎间盘部件的复合材料垫分别嵌入在椭圆柱体的对应端面上的凹槽内。
所述底板的边缘由椭圆弧段以及与该椭圆弧段的两端圆滑过渡连接的M字型曲线段组成,所述椭圆弧段以对应椭圆的短轴对称,所述侧板设置于所述底板边缘的椭圆弧段上,所述侧板向内倾斜并与所述底板呈70~80度夹角,所述侧板上设置有螺孔。
所述底板上设置有椭圆状圆顶以及圆锥状齿突,所述椭圆状圆顶以及圆锥状齿突与所述侧板位于所述底板的同一侧表面,椭圆状圆顶的中心与所述底板中心重合,椭圆状圆顶高度由中心向四周递减,圆锥状齿突沿椭圆线间隔分布于所述底板上。
所述螺孔为两个,两个螺孔不在同一水平面上。
所述复合材料垫包括嵌入在所述椭圆柱体的对应端面上的凹槽内的下椭圆柱、设置于该凹槽开口位置处的与所述下椭圆柱相连的上椭圆柱以及用于作为球窝关节关节头的复合材料球体,所述上椭圆柱上设置有开口为圆形的凹槽,该开口为圆形的凹槽延伸至下椭圆柱内,所述复合材料球体设置于所述开口为圆形的凹槽内,所述复合材料球体与所述上椭圆柱上开口为圆形的凹槽之间留有间隙,所述间隙内设置有与所述复合材料球体配合的用于作为球窝关节关节窝的球壳,所述球壳与设置于所述底板上的圆柱状突起相连。
所述球壳的开口边缘处设置有两个弧形突起,所述两个弧形突起位置相对,所述开口为圆形的凹槽的壁面上设置有两个缺口,两个缺口位置相对,两个弧形突起的外壁面间距小于或者等于所述两个缺口之间的距离,并且该间距大于所述开口为圆形的凹槽开口处的直径。
所述弧形突起关于矢状面对称分布,所述缺口关于冠状面对称分布。
所述圆柱状突起包括与所述底板相连的大圆柱以及与所述大圆柱相连的小圆柱,所述球壳与所述小圆柱相连,所述大圆柱与小圆柱的中心线重合,所述大圆柱以及小圆柱的接触面棱线采用圆角圆滑处理,所述复合材料球体顶端高出所述上椭圆柱,所述上椭圆柱与所述底板相对侧表面的外边缘采用圆角圆滑处理,该表面的内边缘(开口为圆形的凹槽开口处)采用锥形扩大处理。
所述椭圆柱体的侧面上设置有随机分布的若干个圆槽,所述椭圆柱体的中间位置设置有两个相互交叉的矩形贯通槽,两个矩形贯通槽分别沿矢状面与冠状面走行。
所述椭圆柱体、弧形L板以及复合材料垫分别采用一体成型,所述椭圆柱体以及弧形L板采用医用钛合金材质,所述复合材料垫采用超高分子量聚乙烯材质或聚醚醚酮材质,所述弧形L板与骨面接触处以及所述椭圆柱体的侧面均设置有羟基磷灰石涂层。
本发明的有益效果体现在:
本发明所述仿生防脱位人工腰椎及椎间盘连接复合体充分考虑了腰椎的解剖特点,弧形L板用于与邻近椎体紧密结合,有效减少接触面的应力集中,满足了正常腰椎的承重功能,因球窝关节的存在,更加接近生理状态,复合材料垫与椎体部件端部凹槽的嵌入式连接不但起到缓冲作用,而且可以防止因运动过程中椎间隙增宽造成复合材料垫从椎体部件中脱出。
本发明取得的进一步的技术效果如下:
1、由钛合金铸造的带有弧形突起的近半球壳与聚乙烯构成的大半球体共同构成防脱球窝关节,不但使活动中心恰好位于椎间隙中央,避免了因活动中心异位可能引起的潜在并发症,而且保留了椎体的旋转、侧弯、前屈、背伸及一定的缓冲功能,更加接近生理状态。
2、本发明所述弧形L板的底板的形状与腰椎终板前部形状类似,椭圆形圆顶与腰椎终板中央偏后处凹陷相吻合,圆顶上部与周边设有圆锥状齿突,使底板与终板结合更加紧密、牢固。弧形L板的侧板与椎体侧面紧密贴合,增大了接触面积,有效的避免了应力集中,底板上的大圆柱突起能够很好地承受因屈伸运动产生的横向剪切力,避免变形、折断等不良事件的发生。
3、本发明所述椎体部件侧面设有随机分布的圆槽,利于周围组织的附着及残存骨质的长入,中部的两个矩形贯通槽可以容纳较多的植入骨,从而更利于与周围组织的融合,保证了术后长期的稳定性。
4、本发明所述弧形L板与骨面接触处以及椎体部件的侧面均有羟基磷灰石涂层,更加利于与周围组织的融合,保证了活动性与稳定性。
5、本发明所述弧形L板的侧板上设有两个不在同一水平面上的螺孔,通过不同方向的螺钉植入将侧板牢固的固定于临近椎体上,降低了松动脱出的风险。
附图说明
图1为本发明的主视图;
图2为本发明的后视图;
图3为本发明的侧视图;
图4为本发明的俯视图;
图5为本发明的仰视图;
图6为本发明的冠状面剖视图;
图7为本发明的矢状面剖视图;
图8为弧形L板的等轴视图;
图9为复合材料垫的等轴视图;
图10为椎体部件的等轴视图;
图11为弧形L板各参数示意图;
图12为复合材料垫各参数示意图;
图13为仿生防脱位人工椎体及椎间盘连接复合体植入后的示意图;
图中:1为椭圆柱体,2为深凹槽,3为弧形L板,4为复合材料垫,5为椭圆状圆顶,6为圆锥状齿突,7为圆柱状突起,8为弧形突起,9为近半球壳,10为侧板,11为螺孔,12为上椭圆柱,13为下椭圆柱,14为弧形凹槽,15为大半球体,16为缺口,17为上椭圆柱上面边缘,18为底板,19为底板后面棱线,20为大圆柱,21为小圆柱,22为大圆柱与小圆柱接触面棱线,23为弧形凹槽开口,24为小圆槽,25为矩形贯通槽,26为圆柱状凹槽,27为螺钉。
具体实施方式
下面结合附图和实施例对本发明做详细说明。
参见图1-图10,本发明所述仿生防脱位人工腰椎及椎间盘连接复合体,包括椎体部件、椎间盘部件及螺钉27。椎体部件由上下两面带有深凹槽2的椭圆柱体1构成,侧面设有随机分布的小圆槽24及位于中间位置的两个矩形贯通槽25,两矩形贯通槽25分别沿矢状面与冠状面走行,小圆槽24利于周围组织附着,矩形贯通槽25可以进行植骨。在沿冠状面走行的矩形贯通槽开口处上下两侧对称地设有两个圆柱状凹槽26,利于术者夹持连接复合体,便于手术操作。椎间盘部件包括两部分,即与相邻椎体连接的弧形L板3和与椎体部件相连的复合材料垫4,两者通过防脱球窝关节相连。弧形L板3由底板18、弧形侧板10与圆柱状突起7三部分组成,所述底板18呈大半椭圆形,底板后面棱线19处经圆角圆滑处理,其与相邻椎体终板接触面上设有椭圆状圆顶5及圆锥状齿突6,所述椭圆状圆顶5的中心与底板18中心重合,椭圆状圆顶5高度由中心向四周递减,圆锥状齿突6沿椭圆线均匀间隔分布于底板18上;圆柱状突起7设置于底板18与复合材料垫4相对面的椭圆中心,圆柱状突起7包括靠近底板18的大圆柱20与远离底板18的小圆柱21两部分,两者中心线重合,大圆柱与小圆柱接触面棱线22进行圆角圆滑处理,小圆柱21末端为带有两个弧形突起8的近半球壳9结构,所述弧形突起8关于矢状面对称地分布于近半球壳9两侧;所述弧形侧板10横截面呈四分之一椭圆形,位于底板18左前方边缘,并逐渐向内倾斜,弧形侧板10上设有两个不在同一水平面的螺孔11,通过螺钉27将弧形L板3牢固的固定于临近椎体侧面上。复合材料垫4由上下两个椭圆柱构成,上椭圆柱12绕其中心线一周挖有弧形凹槽14,弧形凹槽14内壁面为大半球体15结构,弧形凹槽14外壁面前后设有两个小缺口16,所述两个小缺口16关于冠状面对称地分布于弧形凹槽14外壁面,弧形凹槽14内壁面的大半球体15顶端高出上椭圆柱12,弧形凹槽14开口处进行锥形扩大处理,既可以保证屈伸运动的活动度又可以限制过度运动。弧形凹槽14开口外直径小于近半球壳9上两弧形突起8外壁面间的距离,而弧形凹槽前后小缺口16间的距离则与两弧形突起8外壁面间的距离相等,通过此缺口两弧形突起8可以放入弧形凹槽14,进入后通过旋转,将弧形突起8远离缺口,从而防止近半球壳9从弧形凹槽14中脱出,进一步保证了该球窝关节的稳定性。复合材料垫下椭圆柱设置于椭圆柱体1上的深凹槽2内,可以有效的避免复合材料垫从凹槽中脱出。上椭圆柱上面边缘17进行圆角圆滑处理。该连接复合体中近半球壳9结构与上椭圆柱的大半球体15结构相配合构成球窝关节,球窝关节保证了术后临近椎体的旋转、侧弯、前屈、背伸功能,所述螺钉27分别位于螺孔内。复合材料垫的下椭圆柱与椎体部件的深凹槽2相连接,保证了连接复合体自身的稳定性。
从图6以及图7中可以看出,弧形凹槽14就是用于安放近半球壳9的间隙。
椎体部件以及弧形L板3、螺钉27采取医用钛合金材质一体成型,弧形L板3与骨皮质接触面(如底板上面、弧形侧板内面)以及椎体部件侧面均设有羟基磷灰石涂层,更利于与周围组织的融合,保证了术后的稳定性。复合材料垫4采用超高分子聚乙烯材料或者聚醚醚酮材料一体成型,弧形凹槽14内外两壁面以及近半球壳9结构内外两面均进行抛光处理,可以有效的降低接触面的摩擦。
参见图10,椎体部件的椭圆柱体1高26mm,椭圆长半径为23mm,短半径为15mm,上下两面凹槽(深凹槽)深为10mm,长半径为21mm,短半径为13mm,侧面两个矩形贯通槽25开口为3mm×15mm,随机分布的小圆槽24深为1mm,半径为1mm,圆柱状凹槽26深为1.5mm,半径为1.5mm。
参见图8、图11,弧形L板3的底板18厚约2mm,呈大半椭圆形,弧度为225°,椭圆长半径为23mm,短半径为18mm,底板后面棱线经半径为5mm的圆角圆滑处理。底板18上的椭圆状圆顶5中心高2mm,由中心向四周递减,圆顶长半径为15mm,短半径为10mm,中心与底板中心重合。底板18上的圆锥状齿突6高0.5mm,底半径为0.25mm(图中仅画出部分齿状突起,仅供参考)。弧形L板3的弧形侧板10厚约2mm,呈四分之一椭圆形,高度为12mm,与底板呈70~80度夹角,螺孔11半径2mm。圆柱状突起7总高为5mm,大圆柱20高H1=2mm,小圆柱21高H2=3mm,大圆柱半径为10mm,小圆柱半径为7mm,两者接触面棱线进行半径为1mm的圆角圆滑处理。小圆柱末端近半球壳9厚约2mm,球壳内半径为8.1mm,球壳开口平面与球壳顶点距离D1=5.1mm,两个弧形突起8底部平面与球壳开口平面距离D2=3mm,弧形突起8宽W1=6.8mm。
参见图9、图12,复合材料垫4的上椭圆柱12高3mm,下椭圆柱13高H3=10mm,上椭圆柱长半径为23mm,短半径为15mm,下椭圆柱长半径为21mm,短半径为13mm,上椭圆柱上面边缘进行半径为2mm的圆角圆滑处理。弧形凹槽14宽为2.0mm,深H4=9mm,大半球体15直径φ1=16mm,球体最高点高出上椭圆柱12平面的距离D3=2mm,弧形凹槽开口进行锥形扩大处理,锥形高为3mm,与上椭圆柱端面呈75度夹角(β)。弧形凹槽前后小缺口16深H5=5.3mm,宽为7mm。
羟基磷灰石涂层厚度为20μm。
上述参数可根据人体腰椎大小的差异进行适当变动。
参见图13,本发明所述仿生防脱位人工腰椎及椎间盘连接复合体装配关系如下:复合材料垫4的下椭圆柱13放于椭圆柱体1的深凹槽2中,弧形L板3的圆柱状突起7末端的近半球壳9及弧形突起8结构与复合材料垫4上的弧形凹槽14构成防脱球窝关节,球窝关节各接触面进行高度抛光处理,保证关节在运动过程中较小的摩擦与磨损,螺钉27分别通过螺孔11将弧形L板3固定于邻近椎体上。弧形L板的底板18形状与终板类似,椭圆状圆顶5与椎体终板上的凹陷相吻合,圆锥状齿突6使底板18与邻近终板结合更加牢固,弧形侧板10增加了与邻近椎体的接触面积,有效的减小了应力集中,从而满足腰椎的承重功能。椭圆柱体1设有矩形贯通槽25及随机分布小圆槽24,更利于周围组织的附着、生长,保证了术后的长期稳定性。防脱球窝关节不但保证了植入后椎间盘部位的稳定性,防止假体脱出,而且保留了椎体间的旋转、侧弯、前屈、背伸功能,更加符合人体生理状态。
总之,本发明所述仿生防脱位人工腰椎及椎间盘连接复合体,包括椎体部件、椎间盘部件及螺钉。椎体部件由上下两面带有深凹槽2的椭圆柱体1构成,侧面设有随机分布的小圆槽24及中间位置两个矩形贯通槽25。椎间盘部件包括两部分,即与相邻椎体连接的弧形L板3和与椭圆柱体1相连的复合材料垫4,弧形L板3由底板18、弧形侧板10与圆柱状突起7构成,底板18上设有椭圆状圆顶5及圆锥状齿突6,弧形侧板10上设有两个不在同一平面的螺孔11,圆柱状突起7末端为带有两个弧形突起8的近半球壳9结构;复合材料垫4由上下两个椭圆柱构成,下椭圆柱13设置于椭圆柱体1深凹槽内,上椭圆柱12绕其中心线一周挖有弧形凹槽14,凹槽内面为大半球体15结构,近半球壳结构与上椭圆柱的大半球体结构相配合构成球窝关节,关节面进行抛光处理,与骨面接触处有羟基磷灰石涂层。本发明不但可以替代腰椎手术中取掉的椎体及邻近的椎间盘,而且保留了椎间盘的旋转、屈伸及一定的缓冲功能,既保证了术后的稳定性,又保留了腰椎的活动性,在仿生学上更接近人体生理状态。

Claims (7)

1.一种仿生防脱位人工腰椎及椎间盘连接复合体,其特征在于:该人工腰椎及椎间盘连接复合体包括椎体部件以及设置于椎体部件两端的椎间盘部件,所述椎间盘部件包括弧形L板(3)以及复合材料垫(4),所述弧形L板(3)包括分别与腰椎椎体的终板以及侧面形状相应的底板(18)以及侧板(10),所述侧板(10)设置于所述底板(18)上,所述底板(18)与复合材料垫(4)之间通过球窝关节相连,所述椎体部件包括椭圆柱体(1),椭圆柱体(1)的两个端面上开设有凹槽,两个椎间盘部件的复合材料垫(4)分别嵌入在椭圆柱体(1)的对应端面上的凹槽内;
所述复合材料垫(4)包括嵌入在所述椭圆柱体(1)的对应端面上的凹槽内的下椭圆柱(13)、设置于该凹槽开口位置处的与所述下椭圆柱(13)相连的上椭圆柱(12)以及用于作为球窝关节关节头的复合材料球体,所述上椭圆柱(12)上设置有开口为圆形的凹槽,该开口为圆形的凹槽延伸至下椭圆柱(13)内,所述复合材料球体设置于所述开口为圆形的凹槽内,所述复合材料球体与所述上椭圆柱(12)之间留有间隙,所述间隙内设置有与所述复合材料球体配合的用于作为球窝关节关节窝的球壳,所述球壳与设置于所述底板(18)上的圆柱状突起(7)相连;
所述球壳的开口边缘处设置有两个弧形突起(8),所述两个弧形突起(8)位置相对,所述开口为圆形的凹槽的壁面上设置有两个缺口(16),两个缺口(16)位置相对,两个弧形突起(8)的外壁面间距小于或者等于所述两个缺口(16)之间的距离,并且大于所述开口为圆形的凹槽开口处的直径;
所述圆柱状突起(7)包括与所述底板(18)相连的大圆柱(20)以及与所述大圆柱(20)相连的小圆柱(21),所述球壳与所述小圆柱(21)相连,所述大圆柱(20)与小圆柱(21)的中心线重合,所述大圆柱(20)以及小圆柱(21)的接触面棱线采用圆角圆滑处理,所述复合材料球体顶端高出所述上椭圆柱(12),所述上椭圆柱(12)与所述底板(18)相对侧表面的外边缘采用圆角圆滑处理,该表面的内边缘采用锥形扩大处理。
2.根据权利要求1所述一种仿生防脱位人工腰椎及椎间盘连接复合体,其特征在于:所述底板(18)的边缘由椭圆弧段以及与该椭圆弧段的两端圆滑过渡连接的M字型曲线段组成,所述椭圆弧段以对应椭圆的短轴对称,所述侧板(10)设置于所述底板(18)边缘的椭圆弧段上,所述侧板(10)向内倾斜并与所述底板(18)呈70~80度夹角,所述侧板(10)上设置有螺孔(11)。
3.根据权利要求2所述一种仿生防脱位人工腰椎及椎间盘连接复合体,其特征在于:所述底板(18)上设置有椭圆状圆顶(5)以及圆锥状齿突(6),所述椭圆状圆顶(5)以及圆锥状齿突(6)与所述侧板(10)位于所述底板(18)的同一侧表面,椭圆状圆顶(5)的中心与所述底板(18)中心重合,椭圆状圆顶(5)高度由中心向四周递减,圆锥状齿突(6)沿椭圆线间隔分布于所述底板(18)上。
4.根据权利要求2所述一种仿生防脱位人工腰椎及椎间盘连接复合体,其特征在于:所述螺孔(11)为两个,两个螺孔(11)不在同一水平面上。
5.根据权利要求1所述一种仿生防脱位人工腰椎及椎间盘连接复合体,其特征在于:所述弧形突起(8)关于矢状面对称分布,所述缺口(16)关于冠状面对称分布。
6.根据权利要求1所述一种仿生防脱位人工腰椎及椎间盘连接复合体,其特征在于:所述椭圆柱体(1)的侧面上设置有随机分布的若干个圆槽,所述椭圆柱体(1)的中间位置设置有两个相互交叉的矩形贯通槽(25),两个矩形贯通槽(25)分别沿矢状面与冠状面走行。
7.根据权利要求1所述一种仿生防脱位人工腰椎及椎间盘连接复合体,其特征在于:所述椭圆柱体(1)、弧形L板(3)以及复合材料垫(4)分别采用一体成型,所述椭圆柱体(1)以及弧形L板(3)采用医用钛合金材质,所述复合材料垫(4)采用超高分子量聚乙烯材质或聚醚醚酮材质,所述弧形L板(3)与骨面接触处以及所述椭圆柱体(1)的侧面均设置有羟基磷灰石涂层。
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