CN117084832A - 一种脊柱小关节假体 - Google Patents

一种脊柱小关节假体 Download PDF

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CN117084832A
CN117084832A CN202311332573.XA CN202311332573A CN117084832A CN 117084832 A CN117084832 A CN 117084832A CN 202311332573 A CN202311332573 A CN 202311332573A CN 117084832 A CN117084832 A CN 117084832A
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sleeve
facet joint
spinal facet
prosthesis
spinal
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CN117084832B (zh
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吴浩
丁波
张帅
王亚松
李超
相冶
翟天笑
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Xuanwu Hospital
Beijing AK Medical Co Ltd
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Xuanwu Hospital
Beijing AK Medical Co Ltd
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    • 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
    • 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
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    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
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    • 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
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    • A61F2002/30329Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30331Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementarily-shaped recess, e.g. held by friction fit
    • A61F2002/30362Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementarily-shaped recess, e.g. held by friction fit with possibility of relative movement between the protrusion and the recess
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    • A61F2002/30316The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30329Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30331Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementarily-shaped recess, e.g. held by friction fit
    • A61F2002/30378Spherically-shaped protrusion and recess
    • AHUMAN NECESSITIES
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    • 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
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    • A61F2002/30433Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using additional screws, bolts, dowels, rivets or washers e.g. connecting screws
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    • A61F2002/30518Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements with possibility of relative movement between the prosthetic parts
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    • 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
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    • A61F2002/30316The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30537Special structural features of bone or joint prostheses not otherwise provided for adjustable
    • 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
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30565Special structural features of bone or joint prostheses not otherwise provided for having spring elements
    • A61F2002/30566Helical springs
    • AHUMAN NECESSITIES
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    • 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
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30621Features concerning the anatomical functioning or articulation of the prosthetic joint
    • A61F2002/30649Ball-and-socket joints
    • A61F2002/30662Ball-and-socket joints with rotation-limiting means
    • AHUMAN NECESSITIES
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    • 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
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    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30667Features concerning an interaction with the environment or a particular use of the prosthesis
    • A61F2002/30673Lubricating means, e.g. synovial pocket
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    • 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
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    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2002/3093Special external or bone-contacting surface, e.g. coating for improving bone ingrowth for promoting ingrowth of bone tissue

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Abstract

一种脊柱小关节假体,涉及骨科植入物领域,用来解决脊柱小关节病变后假体的植入并且保证结构与功能的重建,本发明主要包括:底座、弹性部件、限位装置、套筒,通过弹性部件上的球头和底座上的圆环轨道实现脊柱关节的前伸后屈,通过弹性部件的弹簧和套筒中垫片的配合实现脊柱小关节的左右侧摆,同时,为了提升假体的稳定性和适用率,本发明可以根据患者不同,病变位置不同调节限位装置的位置、弹簧的弹性系数、垫片的厚度实现前后和作用运动角度的调节,同时在球头与圆环轨道接触的部位设置有放置润滑材料的小凹槽,保证假体运动的平顺性。

Description

一种脊柱小关节假体
技术领域
本发明涉及医疗器械技术领域,特别是适用于脊柱小关节植入物领域。
背景技术
脊柱小关节植入物是一种用于替代或修复脊柱小关节功能的医疗器械。它通常由生物相容性材料制成,设计用于模拟自然脊柱小关节的运动和稳定性。这些植入物广泛用于治疗脊柱退行性疾病、脊椎变形、骨折或损伤等问题。它们的设计和材料选择旨在提供持久的支持,同时减轻疼痛,恢复脊柱的正常功能,改善患者的生活质量。这些植入物通常由高度耐用的材料制成,例如金属合金、陶瓷或聚乙烯等,以确保其强度和生物相容性。它们的设计结构复杂,旨在模拟自然脊柱小关节的运动范围和灵活性,从而帮助患者恢复正常的脊柱功能。
脊柱小关节植入物的种类多样,包括人工关节、植骨材料和支撑结构等。这些植入物可以根据患者的特定病情和需要进行定制,以提供最佳的治疗效果。手术过程通常涉及将植入物安置在脊柱小关节的位置,以还原脊柱的稳定性和运动功能。随着医学技术的不断进步,脊柱小关节植入物的设计和制造也在不断改进,旨在提供更加精确、耐用和舒适的解决方案,帮助患者缓解疼痛,提高生活质量。
现有技术公开了一种椎骨小面置换装置,其置换小面的骨部分,以便去除关节炎、创伤或其他疾病介导的疼痛的来源。主要包括:可植入椎骨中的固定元件;联接部分,所述联接部分联接至所述固定元件;以及连接到所述连接部分的铰接表面,其中所述铰接表面被成形和定位成抵靠第二小面表面铰接。联接部分具有大致半球形的骨接合表面,该骨接合表面成形为接合椎骨的骨中的大致半球形的切除部分,以便选择性地允许联接部分抵靠椎骨的多轴旋转。
现有技术还公开了一种脊柱小面关节假体,用于替换疼痛或以其他方式受损的小面关节。假体由两个部件组成,即上关节部件和下关节部件。上部部件被设计成替代下关节突的受损关节表面,并且下部部件被设计成替代上关节突的受损关节表面。上部部件大致为具有圆形顶点的一个或金字塔形。这种形式被设计成与下关节突的尖端一致,使得上部件可以覆盖下关节突的整个远侧部分。下部部件在形式上也是大致锥形或棱锥形的。这种形式被设计成与上关节突的尖端一致并覆盖下关节突的远侧部分。下部部件的一侧是凹形的并且向后内侧和向远侧伸长,以在上部部件在下部部件上向内侧和向下移动时覆盖上部部件的偏移。下部部件的前侧是不完整的。它被成形为包含小的椎弓根,以在外科手术放置在患者体内时促进机械稳定性并减少神经损伤。该发明的装置的每个部件由生物相容性材料制成,例如不锈钢、非合金钛或钛铝合金。下部部件的细长侧具有低摩擦系数,使得其对上部部件的移动提供最小的阻力。这可以通过用抛光铬或减摩材料(例如医用级高密度聚乙烯)涂覆细长侧的外表面来实现。已知用于将本发明的装置的每个部件附接到其相应的关节突的各种方法。
现有技术虽然解决了小关节病变压迫周围神经和血管的问题,但是也牺牲了患者的相邻两个椎骨的运动,将上关节突和下关节突固定在一起,尽管现有技术又做出了改进,但是目前的脊柱小关节假体主要解决了脊柱小关节在垂直方向上的运动,与实际的人体运动相比,缺少了脊柱一部分方向上尤其是水平方向上的移动,患者植入假体以后在上身侧摆不流畅,不符合人体功能的重建,同时,铰接结构或者互相分离的两部分假体的结构容易导致假体损坏,进而发生损伤周围神经和血管的危险。
发明内容
为了解决上述现有技术存在的问题,本发明提供了一种可以实现结构与功能重建的脊柱小关节假体,本发明通过圆环形轨道和弹性部件之间的配合,可以实现脊柱的前后伸展和左右侧摆,还可以保证在前后屈伸的时候实现左右的侧摆,例如侧前屈。该脊柱小关节用于连接上关节突和下关节突的接触部位,在实现上述功能的同时还可以充当缓冲结构,减少患者的不适感。具体包括:底座10,所述底座由圆柱体构成,在底座的上表面设置有圆环轨道101,圆环轨道的中间直径大于表面直径,使得弹性部件的球头被限制在圆环轨道中,只能沿着轨道运动,圆环轨道上设置有第一限位孔102,底座的正中心分散设置上关节突固定孔103;限位装置20,所述限位装置由半球体构成,半球体上设置有球窝面201,用来阻挡弹性部件的运动,限位装置的竖直方向上设置有第二限位孔202,限位装置的第二限位孔和圆环轨道上的第一限位孔通过螺钉固定;弹性部件30,所述弹性部件由球头301,限位柱302,弹簧303构成,球头和限位柱固定连接,球头被限制在圆环形轨道中;套筒40,所述套筒由半空心圆柱体构成,套筒的表面设置有两个卡槽401,用来放置限位柱302,套筒顶部设置有空心桶403,空心桶内设置有垫片404,套筒的底部设置有下关节突固定孔403;该假体可以实现脊柱关节的前后屈伸和左右侧摆。
进一步地,所述第一限位孔可以根据患者病变部位的不同设置多个,以实现旋转角度的多级调节,调整脊柱小关节假体的前后屈伸程度。
进一步地,弹性部件的弹簧具有可更换的弹性系数,以适应不同患者的生理需求。
进一步地,套筒的空心桶内设置有润滑剂储存腔,用于维持关节运动时的润滑状态。
进一步地,底座和套筒与人体骨骼接触的平面设置有骨小梁结构,用于促进骨组织生长,增强假体的固定性。
进一步地,底座的圆环轨道上设置有微小凹槽,用于嵌入润滑材料,减小关节摩擦,延长假体使用寿命。
进一步地,套筒的底部与弹性部件接触到的部位设置有可调节高度的垫片,以适应不同患者的脊柱结构和需求。
进一步地,套筒表面的两个卡槽可以根据需要调整卡槽的长度,以调整左右侧摆的最大角度。
本发明在通过设计圆环形轨道,配合弹性部件实现了脊柱小关节的全方位运动,并且,医生可以根据患者病变位置的不同调节限位装置的位置,例如,颈椎部位前屈和后伸的角度为35°-45°,左右0°-45°,腰椎前屈90°,后伸30°,侧屈30°,通过调节限位装置的位置可以实现不同部位的角度需求。本发明中弹性部件的弹性系数也可以根据患者的需要进行调整,通过调整弹簧的弹性系数和套筒中垫片的大小可以实现左右角度极限的调整。为了减少球头与圆环轨道的摩擦,在圆环轨道上设置有微小凹槽,内嵌入润滑材料,提升假体的稳定性,同样在套筒内设置有润滑剂的存储腔,保证弹性部件的运动更加平顺,在底座的底部和侧面,套筒的底部和侧面都设置骨小梁结构,诱导骨生长,加强人体与假体的融合,提高假体的使用寿命。
附图说明
附图中的图示及其说明对于本发明的理解具有帮助,
图1是脊柱小关节假体的爆炸图;
图2是底座的俯视图;
图3是底座的剖视图;
图4是限位装置的正视图;
图5是限位装置的剖视图;
图6是弹性部件的正视图;
图7是套筒的正视图;
图8是套筒的剖面图;
其中,包括以下附图标记:10、底座;101、圆环轨道;102、第一限位孔;103、上关节突固定孔;20、限位装置;201、球窝面;202、第二限位孔;30、弹性部件;301、球头;302限位柱;303、弹簧;40、套筒;401、卡槽;402、空心桶;403、下关节突固定孔;404、垫片。
具体实施方式
下面将结合本发明实施例中的附图,对本发明实施例中的技术方案进行清楚、完整的描述,显然,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例。以下对至少一个示例性实施例的描述实际上仅仅是说明性的,决不作为对本发明及其应用或使用的任何限制。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。
需要注意的是,这里所使用的术语仅是为了描述具体实施方式,而非意图限制根据本申请的示例性实施方式。如在这里所使用的,除非上下文另外明确指出,否则单数形式也意图包括复数形式,此外,还应当理解的是,当在本说明书中使用术语“包含”和/或“包括”时,其指明存在特征、步骤、操作、器件、组件和/或它们的组合。
除非另外具体说明,否则在这些实施例中阐述的部件和步骤的相对布置、数字表达式和数值不限制本发明的范围。同时,应当明白,为了便于描述,附图中所示出的各个部分的尺寸并不是按照实际的比例关系绘制的。对于相关领域普通技术人员已知的技术、方法和设备可能不作详细讨论,但在适当情况下,所述技术、方法和设备应当被视为授权说明的一部分。在这里示出和讨论的所有示例中,任何具体值应被解释为仅仅是示例性的,而不是作为限制。因此,示例性实施例的其他示例可以具有不同的值。应注意到:相似的标号和字母在下面的附图中表示类似项,因此,一旦某一项在一个附图中被定义,则在随后的附图中不需要对其进行进一步讨论。
如图1-8所示,一种脊柱小关节假体具体包括:底座10,所述底座由圆柱体构成,在底座的上表面设置有圆环轨道101,圆环轨道的中间直径大于表面直径,使得弹性部件的球头被限制在圆环轨道中,只能沿着轨道运动,圆环轨道上设置有第一限位孔102,底座的正中心分散设置上关节突固定孔103;限位装置20,所述限位装置由半球体构成,半球体上设置有球窝面201,用来阻挡弹性部件的运动,限位装置的竖直方向上设置有第二限位孔202,限位装置的第二限位孔和圆环轨道上的第一限位孔通过螺钉固定;弹性部件30,所述弹性部件由球头301,限位柱302,弹簧303构成,球头和限位柱固定连接,球头被限制在圆环形轨道中;套筒40,所述套筒由半空心圆柱体构成,套筒的表面设置有两个卡槽401,用来放置限位柱302,套筒顶部设置有空心桶403,空心桶内设置有垫片404,套筒的底部设置有下关节突固定孔403;进一步地,所述第一限位孔可以根据患者病变部位的不同设置多个,以实现旋转角度的多级调节,调整脊柱小关节假体的前后屈伸程度。弹性部件的弹簧具有可更换的弹性系数,以适应不同患者的生理需求。套筒的空心桶内设置有润滑剂储存腔,用于维持关节运动时的润滑状态。底座和套筒与人体骨骼接触的平面设置有骨小梁结构,用于促进骨组织生长,增强假体的固定性。底座的圆环轨道上设置有微小凹槽,用于嵌入润滑材料,减小关节摩擦,延长假体使用寿命。套筒的底部与弹性部件接触到的部位设置有可调节高度的垫片,以适应不同患者的脊柱结构和需求。套筒表面的两个卡槽可以根据需要调整卡槽的长度,以调整左右侧摆的最大角度。
在安装的过程中,可以对底座进行加热,由于热胀冷缩的作用,圆环轨道会膨胀,然后将弹性部件上的球头嵌入到圆环轨道中,同样的做法将限位装置安装在圆环轨道中,套筒与弹性部件之间的连接可以采用3D打印的方式,将二者连接。在使用过程中,首先根据患者的需要定制脊柱小关节假体,确定限位装置的固定位置,确定弹簧的弹性系数和套筒中垫片的厚度,然后将限位装置通过第二限位孔和第一限位孔使用螺钉固定,最后将底座和套筒分别安装在上关节突和下关节突上,患者在运动的过程中,前屈后伸通过圆环轨道和球头实现,球头可以在圆环轨道内运动,左右侧摆通过弹性部件和套筒的配合实现,限位柱的作用可以防止假体左右侧摆的幅度过大导致其他关节受损或弹性部件脱落。
为了提升假体的适用率和稳定性,本发明通过设置多个第一限位孔调节限位装置来适应腰椎、颈椎、尾椎的不同的前屈后伸角度,通过调节弹性部件和套筒内垫片的大小实现左右侧摆角度的调节。在球头和圆环轨道的接触面设置有多个小凹槽用于嵌入润滑材料,减小关节摩擦。本发明的设计可以对称的应用在脊柱的左右两侧小关节,只需调整套筒和底座的固定位置即可。

Claims (8)

1.一种脊柱小关节假体,其特征在于,包括:底座,所述底座由圆柱体构成,在底座的上表面设置有圆环轨道,圆环轨道上设置有第一限位孔,底座的正中心分散设置上关节突固定孔;限位装置,所述限位装置由半球体构成,半球体上设置有球窝面,用来阻挡弹性部件的运动,限位装置的竖直方向上设置有第二限位孔,限位装置的第二限位孔和圆环轨道上的第一限位孔通过螺钉固定;弹性部件,所述弹性部件由球头,限位柱,弹簧构成,球头和限位柱固定连接,球头被限制在圆环形轨道中;套筒,所述套筒由半空心圆柱体构成,套筒的表面设置有两个卡槽,用来放置限位柱,套筒顶部设置有空心桶,空心桶内设置有垫片,套筒的底部设置有下关节突固定孔;该假体可以实现脊柱关节的前后屈伸和左右侧摆。
2.根据权利要求1所述的脊柱小关节假体,其特征在于:所述第一限位孔可以根据患者病变部位的不同设置多个,以实现旋转角度的多级调节,调整脊柱小关节假体的前后屈伸程度。
3.根据权利要求1所述的脊柱小关节假体,其特征在于:弹性部件的弹簧具有可更换的弹性系数,以适应不同患者的生理需求。
4.根据权利要求1所述的脊柱小关节假体,其特征在于:套筒的空心桶内设置有润滑剂储存腔,用于维持关节运动时的润滑状态。
5.根据权利要求1所述的脊柱小关节假体,其特征在于:底座和套筒与人体骨骼接触的平面设置有骨小梁结构,用于促进骨组织生长,增强假体的固定性。
6.根据权利要求1所述的脊柱小关节假体,其特征在于:底座的圆环轨道上设置有微小凹槽,用于嵌入润滑材料,减小关节摩擦,延长假体使用寿命。
7.根据权利要求1所述的脊柱小关节假体,其特征在于:套筒的底部与弹性部件接触到的部位设置有可调节高度的垫片,以适应不同患者的脊柱结构和需求。
8.根据权利要求1所述的脊柱小关节假体,其特征在于:套筒表面的两个卡槽可以根据需要调整卡槽的长度,以调整左右侧摆的最大角度。
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