技术领域technical field
本实用新型涉及骨科植入物技术领域，具体而言，涉及一种脊柱固定组件。The utility model relates to the technical field of orthopedic implants, in particular to a spinal fixation assembly.
背景技术Background technique
目前，在脊柱外科领域，由于脊柱肿瘤、陈旧性脊柱创伤、脊柱结核、先天性脊柱畸形、严重的椎管狭窄脊髓压迫症等等病变，在治疗中往往需要对脊柱后路椎板、横突棘突、上下关节突进行手术切除，甚至是椎体节段的整体手术摘除。此后，再进行后路固定术并辅之以前路融合术，从而对位于脊柱进行部分切除或整体摘除的部位的上下两侧的两个椎体节段进行固定。然而，采用上述手术方法术后造成的椎板的缺失无法修补，这样会导致脊髓硬脊膜的外侧失去了骨质的屏障保护作用，直接被肌肉和皮肤所覆盖。此外，还会发生硬膜囊与神经根粘连等术后并发症，给病人带来极大痛苦与不便。At present, in the field of spinal surgery, due to spinal tumors, old spinal trauma, spinal tuberculosis, congenital spinal deformity, severe spinal stenosis and spinal cord compression, it is often necessary to treat the posterior lamina, transverse process, etc. The spinous process, the upper and lower articular processes are surgically removed, and even the entire vertebral segment is surgically removed. Thereafter, posterior fixation supplemented by anterior fusion fixes the two vertebral body segments located on the upper and lower sides of the part of the spine where partial resection or en bloc resection is performed. However, the loss of the lamina caused by the above-mentioned surgical method cannot be repaired, which will cause the outer side of the spinal dura mater to lose the protective effect of the bone barrier and be directly covered by muscle and skin. In addition, postoperative complications such as dural sac and nerve root adhesion will occur, which will bring great pain and inconvenience to the patient.
实用新型内容Utility model content
本实用新型的主要目的在于提供一种脊柱固定组件，以解决现有技术中的脊柱椎体在进行部分切除或整体摘除后相应部位的脊髓硬脊膜缺乏骨质的屏障保护的问题。The main purpose of the utility model is to provide a spinal fixation assembly to solve the problem in the prior art that the spinal dura mater at the corresponding position lacks bone barrier protection after partial resection or overall removal of the vertebral body.
为了实现上述目的，本实用新型提供了一种脊柱固定组件，包括：两个椎管覆盖板，两个椎管覆盖板呈角度连接，以在两个椎管覆盖板之间形成第一凹部，第一凹部的开口朝向脊柱椎管；固定结构，固定结构与两个椎管覆盖板相配合，以将两个椎管覆盖板固定在脊柱椎管的后方并与脊柱椎管的前方的患处椎体相对应的位置。In order to achieve the above object, the utility model provides a spinal fixation assembly, comprising: two spinal canal cover plates connected at an angle to form a first recess between the two spinal canal cover plates, The opening of the first recess is towards the vertebral canal of the spine; the fixing structure is matched with the two covering plates of the spinal canal to fix the two covering plates of the spinal canal at the rear of the vertebral canal of the spine and the affected vertebrae at the front of the vertebral canal of the spine. The corresponding position of the body.
进一步地，椎管覆盖板为平直板或弧形板。Further, the spinal canal covering plate is a straight plate or an arc plate.
进一步地，脊柱固定组件还包括关节突连接板，关节突连接板设置在两个椎管覆盖板中的至少一个上，关节突连接板设置在椎管覆盖板远离脊柱椎管的一侧并沿远离脊柱椎管的方向延伸，关节突连接板的上端具有第一关节突结合部，关节突连接板的下端具有第二关节突结合部。Further, the spinal column fixation assembly also includes a facet joint plate, which is arranged on at least one of the two spinal canal covering plates, and the facet joint plate is set on the side of the spinal canal cover plate away from the spinal canal and along the Extending away from the direction of the spinal canal, the upper end of the articular process connecting plate has a first articular process joint part, and the lower end of the articular process connecting plate has a second articular process joint part.
进一步地，第一关节突结合部包括设置在关节突连接板的上端的内侧的第一关节突结合面，第二关节突结合部包括设置在关节突连接板的下端的外侧的第二关节突结合面。Further, the first facet joint part includes a first facet joint surface arranged on the inner side of the upper end of the facet joint plate, and the second facet joint part includes a second facet joint surface arranged on the outer side of the lower end of the facet joint plate Joint surface.
进一步地，脊柱固定组件还包括骨结合板，骨结合板设置在两个椎管覆盖板中的至少一个上，骨结合板与对应的椎管覆盖板呈角度连接，以在骨结合板与该椎管覆盖板之间形成第二凹部，第二凹部的开口方向与第一凹部的开口方向相反，骨结合板朝向患处椎体的一侧的表面形成骨结合面，当关节突连接板设置在该椎管覆盖板上时，关节突连接板的至少部分位于第二凹部内。Further, the spinal fixation assembly also includes an osseointegration plate, which is arranged on at least one of the two vertebral canal covering plates, and the osseointegration plate is connected to the corresponding vertebral canal covering plate at an angle so that the osseointegration plate and the osseointegration plate are connected at an angle. A second recess is formed between the covering plates of the spinal canal. The opening direction of the second recess is opposite to that of the first recess. The surface of the osseointegration plate facing the affected vertebral body forms an osseointegration surface. When the articular process connecting plate is placed on When the spinal canal covers the plate, at least part of the facet connecting plate is located in the second recess.
进一步地，固定结构包括固定棒以及第一椎弓根螺钉，固定棒的两端分别通过第一椎弓根螺钉固定在位于患处椎体的上方和下方的两个生理椎体节段上，固定棒与骨结合板相配合，以将两个椎管覆盖板固定在脊柱椎管的后方并与脊柱椎管的前方的患处椎体相对应的位置。Further, the fixation structure includes a fixation rod and a first pedicle screw, and the two ends of the fixation rod are respectively fixed on two physiological vertebral body segments above and below the affected vertebral body through the first pedicle screw, and the fixed The rod cooperates with the osseointegration plate to fix the two spinal canal covering plates at the rear of the spinal canal and at the position corresponding to the affected vertebral body in the front of the spinal canal.
进一步地，骨结合板远离椎管覆盖板的一侧具有能够通过压紧方式进行固定的固定棒结合部，当固定棒的两端固定在两个生理椎体节段上后，固定棒压入固定棒结合部并将固定棒结合部压紧固定。Furthermore, the side of the osseointegration plate far away from the vertebral canal covering plate has a fixing rod junction that can be fixed by compression. When the two ends of the fixing rod are fixed on two physiological vertebral body segments, the fixing rod is pressed into the Fix the joint of the rod and press and fix the joint of the fixed rod.
进一步地，骨结合板远离椎管覆盖板的一侧具有固定棒结合部，固定棒结合部与固定棒之间通过焊接连接或者通过3D打印技术直接打印形成一体结构。Furthermore, the side of the osseointegration plate away from the vertebral canal covering plate has a fixed rod joint, and the fixed rod joint and the fixed rod are connected by welding or directly printed by 3D printing technology to form an integrated structure.
进一步地，固定结构还包括锁合结构，锁合结构包括：安装柱，设置在固定棒结合部上，安装柱具有沿固定棒的延伸方向贯通设置的通槽，通槽的槽壁上设置有内螺纹；压棒螺帽，压棒螺帽的外壁上设置有与内螺纹相适配的外螺纹，当固定棒穿设在通槽内后，压棒螺帽嵌入至通槽内并与通槽通过外螺纹和内螺纹连接，以将固定棒锁紧在安装柱上。Further, the fixing structure also includes a locking structure, and the locking structure includes: a mounting column, which is arranged on the joint part of the fixing rod, and the mounting column has a through groove arranged through the extending direction of the fixing rod, and the groove wall of the through groove is provided with Internal thread; pressure rod nut, the outer wall of the pressure rod nut is provided with an external thread that is compatible with the internal thread. The grooves are connected by external threads and internal threads to lock the fixing bar on the mounting post.
进一步地，固定结构还包括第二椎弓根螺钉，骨结合板上设置有用于穿设第二椎弓根螺钉的螺钉孔，固定棒和骨结合板通过第二椎弓根螺钉固定在患处椎体上。Further, the fixation structure also includes a second pedicle screw, and the osseointegration plate is provided with a screw hole for passing the second pedicle screw, and the fixation rod and the osseointegration plate are fixed on the affected vertebrae through the second pedicle screw. physically.
进一步地，脊柱固定组件还包括棘突板，棘突板连接在两个椎管覆盖板的连接处并朝向背离两个椎管覆盖板的方向延伸。Further, the spinal column fixation assembly further includes a spinous process plate, which is connected at the junction of the two spinal canal covering plates and extends in a direction away from the two spinal canal covering plates.
进一步地，棘突板的上端和下端均设置有棘突结合部，两个棘突结合部分别与位于患处椎体的上方和下方的两个生理椎体节段的棘突抵顶配合。Further, the upper end and the lower end of the spinous process plate are provided with spinous process junctions, and the two spinous process junctions respectively abut and cooperate with the spinous processes of the two physiological vertebral body segments located above and below the affected vertebral body.
进一步地，棘突板和/或椎管覆盖板上设置有缝合孔。Further, the spinous process plate and/or the spinal canal covering plate are provided with suture holes.
进一步地，棘突板上设置有第一多孔层，第一多孔层为三维贯通的第一通孔结构，该第一通孔结构的孔径为150μm至2000μm。Further, the spinous process plate is provided with a first porous layer, the first porous layer is a three-dimensional through-hole structure, and the diameter of the first through-hole structure is 150 μm to 2000 μm.
进一步地，椎管覆盖板上设置有第二多孔层，第二多孔层为三维贯通的第二通孔结构，该第二通孔结构的孔径为150μm至2000μm。Further, a second porous layer is provided on the vertebral canal covering plate, and the second porous layer is a second through-hole structure through three-dimensionally, and the diameter of the second through-hole structure is 150 μm to 2000 μm.
进一步地，第二多孔层设置在椎管覆盖板背离脊柱椎管的外表面上，椎管覆盖板朝向脊柱椎管的内表面为光滑的实体金属表面。Further, the second porous layer is arranged on the outer surface of the spinal canal covering plate away from the spinal canal, and the inner surface of the spinal canal covering plate facing the spinal canal is a smooth solid metal surface.
进一步地，第一关节突结合部和/或第二关节突结合部为三维贯通的第一多孔通孔结构，该第一多孔通孔结构的孔径为150μm至1200μm。Further, the first articular process junction and/or the second articular process junction is a three-dimensionally penetrated first porous through-hole structure, and the pore diameter of the first porous through-hole structure is 150 μm to 1200 μm.
进一步地，棘突结合部为三维贯通的第二多孔通孔结构，该第二多孔通孔结构的孔径为150μm至1200μm。Further, the spinous process joint part is a second porous through-hole structure through three-dimensionally, and the pore diameter of the second porous through-hole structure is 150 μm to 1200 μm.
进一步地，骨结合板朝向患处椎体的一侧设置有第三多孔层，第三多孔层为三维贯通的第三通孔结构，该第三通孔结构的孔径为150μm至1200μm。Further, the side of the osseointegration plate facing the affected vertebral body is provided with a third porous layer, the third porous layer is a three-dimensional through-hole structure, and the diameter of the third through-hole structure is 150 μm to 1200 μm.
进一步地，位于第一凹部的一侧的骨结合板为多个，多个骨结合板沿同侧的关节突连接板的延伸方向间隔设置，并且该关节突连接板上设置有神经根通道避让缺口。Further, there are multiple osseointegration plates on one side of the first recess, and the multiple osseointegration plates are arranged at intervals along the extension direction of the articular process connecting plate on the same side, and the articular process connecting plate is provided with nerve root channel avoidance gap.
进一步地，患处椎体为人体生理椎体或人工椎体假体。Further, the affected vertebral body is a human physiological vertebral body or an artificial vertebral body prosthesis.
应用本实用新型的技术方案，两个椎管覆盖板之间形成第一凹部。该第一凹部的开口朝向脊柱椎管(即朝向人体的前方)。具体地，第一凹部对应脊柱椎体被部分切除或整体摘除的患处椎体的位置设置，固定结构与两个椎管覆盖板相配合，以将两个椎管覆盖板固定在脊柱椎管的后方并与脊柱椎管的前方的上述患处椎体相对应的位置。此时，脊柱椎管内的脊髓被容纳在第一凹部的内侧，也就是说，两个椎管覆盖板能够形成屏障，实现对脊髓硬脊膜的保护作用，避免发生硬膜囊与神经根粘连等术后并发症，减轻病人的痛苦。By applying the technical scheme of the utility model, a first recess is formed between the two vertebral canal covering plates. The opening of the first recess faces the spinal canal (that is, faces the front of the human body). Specifically, the first concave portion is set corresponding to the position of the affected vertebral body where the vertebral body of the spine is partially resected or completely removed, and the fixing structure cooperates with the two spinal canal covering plates to fix the two spinal canal covering plates on the vertebral canal of the spinal column. The position corresponding to the above-mentioned affected vertebral body in the rear and in front of the spinal canal. At this time, the spinal cord in the spinal canal is accommodated inside the first recess, that is to say, the two spinal canal covering plates can form a barrier to protect the spinal dura mater and prevent the dural sac from collapsing with the nerve roots. Adhesions and other postoperative complications can reduce the pain of patients.
附图说明Description of drawings
构成本申请的一部分的说明书附图用来提供对本实用新型的进一步理解，本实用新型的示意性实施例及其说明用于解释本实用新型，并不构成对本实用新型的不当限定。在附图中：The accompanying drawings constituting a part of this application are used to provide a further understanding of the utility model, and the schematic embodiments of the utility model and their descriptions are used to explain the utility model and do not constitute improper limitations to the utility model. In the attached picture:
图1示出了根据本实用新型的脊柱固定组件的实施例一的结构示意图；Fig. 1 shows a schematic structural view of Embodiment 1 of the spinal fixation assembly according to the present invention;
图2示出了图1的脊柱固定组件的剖视示意图；Fig. 2 shows a schematic cross-sectional view of the spinal fixation assembly of Fig. 1;
图3示出了图1的脊柱固定组件与脊柱的装配过程示意图；Fig. 3 shows a schematic diagram of the assembly process of the spinal fixation assembly of Fig. 1 and the spine;
图4示出了图1的脊柱固定组件与脊柱相配合的结构示意图；Fig. 4 shows a schematic diagram of the structure of the spinal fixation assembly in Fig. 1 cooperating with the spine;
图5示出了根据本实用新型的脊柱固定组件的实施例二的剖视示意图；Fig. 5 shows a schematic cross-sectional view of Embodiment 2 of the spinal fixation assembly according to the present invention;
图6示出了根据本实用新型的脊柱固定组件的实施例三的剖视示意图；Fig. 6 shows a schematic cross-sectional view of Embodiment 3 of the spinal fixation assembly according to the present invention;
图7示出了根据本实用新型的脊柱固定组件的实施例四与脊柱相配合(脊柱固定组件前方为人体生理椎体)的结构示意图；Fig. 7 shows the structure schematic diagram of embodiment 4 of the spinal fixation assembly according to the present utility model cooperating with the spine (the front of the spinal column fixation assembly is the physiological vertebral body of the human body);
图8示出了图7的脊柱固定组件与脊柱(脊柱固定组件前方为设置在上下两个生理椎体节段之间的钛笼)的分解结构示意图；Fig. 8 shows the schematic diagram of the exploded structure of the spinal fixation assembly of Fig. 7 and the spine (the front of the spinal fixation assembly is a titanium cage arranged between the upper and lower physiological vertebral body segments);
图9示出了图8的脊柱固定组件与脊柱相配合(脊柱固定组件前方为设置在上下两个生理椎体节段之间的钛笼)的结构示意图；Fig. 9 shows the structural representation of the spinal fixation assembly of Fig. 8 cooperating with the spine (the front of the spinal fixation assembly is a titanium cage arranged between the upper and lower physiological vertebral body segments);
图10示出了根据本实用新型的脊柱固定组件的实施例五的剖视示意图；Fig. 10 shows a schematic cross-sectional view of Embodiment 5 of the spinal fixation assembly according to the present invention;
图11示出了图10的脊柱固定组件与脊柱相配合的结构示意图；Fig. 11 shows a schematic diagram of the structure of the spinal fixation assembly in Fig. 10 cooperating with the spine;
图12示出了根据本实用新型的脊柱固定组件的实施例六的剖视示意图；Fig. 12 shows a schematic cross-sectional view of Embodiment 6 of the spinal fixation assembly according to the present invention;
图13示出了图12的脊柱固定组件的结构示意图；Fig. 13 shows a schematic structural view of the spinal fixation assembly of Fig. 12;
图14示出了根据本实用新型的脊柱固定组件的实施例七的结构示意图；Fig. 14 shows a schematic structural view of Embodiment 7 of the spinal fixation assembly according to the present invention;
图15示出了根据本实用新型的脊柱固定组件的实施例八的分解结构示意图；Fig. 15 shows a schematic diagram of an exploded structure of Embodiment 8 of the spinal fixation assembly according to the present invention;
图16示出了图15的脊柱固定组件与脊柱的装配过程示意图；Fig. 16 shows a schematic diagram of the assembly process of the spinal fixation assembly of Fig. 15 and the spine;
图17示出了图15的脊柱固定组件的椎管覆盖板、关节突连接板、骨结合板以及棘突板的结构示意图；以及Fig. 17 shows a schematic structural view of the spinal canal covering plate, articular process connecting plate, osseointegration plate and spinous process plate of the spinal fixation assembly of Fig. 15; and
图18示出了根据本实用新型的脊柱固定组件的实施例九的分解结构示意图。Fig. 18 shows a schematic diagram of an exploded structure of Embodiment 9 of the spinal fixation assembly according to the present invention.
其中，上述附图包括以下附图标记：Wherein, the above-mentioned accompanying drawings include the following reference signs:
10、椎管覆盖板；20、关节突连接板；21、第一关节突结合部；22、第二关节突结合部；30、骨结合板；31、固定棒结合部；32、螺钉孔；40、固定棒；50、第一椎弓根螺钉；60、锁合结构；61、安装柱；611、通槽；62、压棒螺帽；70、第二椎弓根螺钉；80、棘突板；81、棘突结合部；90、缝合孔；101、第一多孔层；102、第二多孔层；103、第三多孔层；23、神经根通道避让缺口；200、钛笼。10. Spinal canal covering plate; 20. Facet connecting plate; 21. First facet joint; 22. Second facet joint; 30. Osseointegration plate; 31. Fixation rod joint; 32. Screw hole; 40. Fixing rod; 50. First pedicle screw; 60. Locking structure; 61. Mounting column; 611. Through groove; 62. Pressure rod nut; 70. Second pedicle screw; 80. Spinous process plate ; 81, spinous process junction; 90, suture hole; 101, the first porous layer; 102, the second porous layer; 103, the third porous layer;
具体实施方式Detailed ways
需要说明的是，在不冲突的情况下，本申请中的实施例及实施例中的特征可以相互组合。下面将参考附图并结合实施例来详细说明本实用新型。It should be noted that, in the case of no conflict, the embodiments in the present application and the features in the embodiments can be combined with each other. The utility model will be described in detail below with reference to the accompanying drawings and in conjunction with the embodiments.
下面将结合本实用新型实施例中的附图，对本实用新型实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本实用新型一部分实施例，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，决不作为对本实用新型及其应用或使用的任何限制。基于本实用新型中的实施例，本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其他实施例，都属于本实用新型保护的范围。The technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of them. example. The following description of at least one exemplary embodiment is merely illustrative in nature, and in no way serves as any limitation of the invention and its application or use. Based on the embodiments of the present utility model, all other embodiments obtained by persons of ordinary skill in the art without making creative efforts belong to the scope of protection of the present utility model.
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。It should be noted that the terminology used here is only for describing specific implementations, and is not intended to limit the exemplary implementations according to the present application. As used herein, unless the context clearly dictates otherwise, the singular is intended to include the plural, and it should also be understood that when the terms "comprising" and/or "comprising" are used in this specification, they mean There are features, steps, operations, means, components and/or combinations thereof.
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实用新型的范围。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书的一部分。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，示例性实施例的其它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。The relative arrangements of components and steps, numerical expressions and numerical values set forth in these embodiments do not limit the scope of the present invention unless specifically stated otherwise. At the same time, it should be understood that, for the convenience of description, the sizes of the various parts shown in the drawings are not drawn according to the actual proportional relationship. Techniques, methods and devices known to those of ordinary skill in the relevant art may not be discussed in detail, but where appropriate, such techniques, methods and devices should be considered part of the Authorized Specification. In all examples shown and discussed herein, any specific values should be construed as illustrative only, and not as limiting. Therefore, other examples of the exemplary embodiment may have different values. It should be noted that like numbers and letters denote similar items in the following figures, therefore, once an item is defined in one figure, it does not require further discussion in subsequent figures.
在本实用新型的描述中，需要理解的是，方位词如“前、后、上、下、左、右”、“横向、竖向、垂直、水平”和“顶、底”等所指示的方位或位置关系通常是基于附图所示的方位或位置关系，仅是为了便于描述本实用新型和简化描述，在未作相反说明的情况下，这些方位词并不指示和暗示所指的装置或元件必须具有特定的方位或者以特定的方位构造和操作，因此不能理解为对本实用新型保护范围的限制；方位词“内、外”是指相对于各部件本身的轮廓的内外。In the description of the present utility model, it should be understood that orientation words such as "front, back, up, down, left, right", "horizontal, vertical, vertical, horizontal" and "top, bottom" etc. indicate The orientation or positional relationship is generally based on the orientation or positional relationship shown in the drawings, and is only for the convenience of describing the utility model and simplifying the description. In the absence of a contrary statement, these orientation words do not indicate or imply the referred device Or components must have a specific orientation or be constructed and operated in a specific orientation, so it cannot be construed as limiting the protection scope of the present utility model; the orientation words "inside and outside" refer to the inside and outside relative to the outline of each component itself.
为了便于描述，在这里可以使用空间相对术语，如“在……之上”、“在……上方”、“在……上表面”、“上面的”等，用来描述如在图中所示的一个器件或特征与其他器件或特征的空间位置关系。应当理解的是，空间相对术语旨在包含除了器件在图中所描述的方位之外的在使用或操作中的不同方位。例如，如果附图中的器件被倒置，则描述为“在其他器件或构造上方”或“在其他器件或构造之上”的器件之后将被定位为“在其他器件或构造下方”或“在其他器件或构造之下”。因而，示例性术语“在……上方”可以包括“在……上方”和“在……下方”两种方位。该器件也可以其他不同方式定位(旋转90度或处于其他方位)，并且对这里所使用的空间相对描述作出相应解释。For the convenience of description, spatially relative terms may be used here, such as "on ...", "over ...", "on the surface of ...", "above", etc., to describe the The spatial positional relationship between one device or feature shown and other devices or features. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, devices described as "above" or "above" other devices or configurations would then be oriented "beneath" or "above" the other devices or configurations. under other devices or configurations". Thus, the exemplary term "above" can encompass both an orientation of "above" and "beneath". The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptions used herein interpreted accordingly.
此外，需要说明的是，使用“第一”、“第二”等词语来限定零部件，仅仅是为了便于对相应零部件进行区别，如没有另行声明，上述词语并没有特殊含义，因此不能理解为对本实用新型保护范围的限制。In addition, it should be noted that the use of words such as "first" and "second" to define components is only for the convenience of distinguishing corresponding components. To limit the scope of protection of the utility model.
如图1至图4所示，实施例一的脊柱固定组件包括两个椎管覆盖板10和固定结构。其中，两个椎管覆盖板10呈角度连接，以在两个椎管覆盖板10之间形成第一凹部。第一凹部的开口朝向脊柱椎管(即朝向人体的前方)。固定结构与两个椎管覆盖板10相配合，以将两个椎管覆盖板10固定在脊柱椎管的后方并与脊柱椎管的前方的患处椎体相对应的位置。As shown in FIGS. 1 to 4 , the spinal fixation assembly of Embodiment 1 includes two spinal canal covering plates 10 and a fixing structure. Wherein, two spinal canal covering plates 10 are connected at an angle to form a first recess between the two spinal canal covering plates 10 . The opening of the first recess faces the spinal canal (that is, faces the front of the human body). The fixing structure cooperates with the two spinal canal covering plates 10 to fix the two spinal canal covering plates 10 at the rear of the spinal canal and corresponding to the affected vertebral body in front of the spinal canal.
应用本实施例的脊柱固定组件，两个椎管覆盖板10之间形成第一凹部。该第一凹部的开口朝向脊柱椎管(即朝向人体的前方)。具体地，第一凹部对应脊柱椎体被部分切除或整体摘除的患处椎体的位置设置，固定结构与两个椎管覆盖板10相配合，以将两个椎管覆盖板10固定在脊柱椎管的后方并与脊柱椎管的前方的上述患处椎体相对应的位置。此时，脊柱椎管内的脊髓被容纳在第一凹部的内侧，也就是说，两个椎管覆盖板10能够形成屏障，实现对脊髓硬脊膜的保护作用，避免发生硬膜囊与神经根粘连等术后并发症，减轻病人的痛苦。With the spinal fixation assembly of this embodiment, a first recess is formed between the two spinal canal covering plates 10 . The opening of the first recess faces the spinal canal (that is, faces the front of the human body). Specifically, the first concave part is set corresponding to the position of the affected vertebral body where the vertebral body of the spinal column is partially resected or removed entirely, and the fixing structure cooperates with the two spinal canal covering plates 10 to fix the two spinal canal covering plates 10 on the vertebral body of the spinal column. The rear of the canal and the position corresponding to the above-mentioned affected vertebral body in front of the spinal canal. At this time, the spinal cord in the spinal canal is accommodated inside the first recess, that is to say, the two spinal canal covering plates 10 can form a barrier to protect the spinal dura mater and prevent the dural sac from colliding with the nerves. Root adhesions and other postoperative complications, reducing the pain of patients.
需要说明的是，两个椎管覆盖板10呈角度连接指的是，两个椎管覆盖板10的各自的大致设置方向之间呈角度。在本实施例中，椎管覆盖板10为平直板，两个平直板呈角度连接。当然，椎管覆盖板10的具体结构不限于此，在其他实施方式中，椎管覆盖板可以不为平直板，例如，椎管覆盖板可以为弧形板、不规则形状板等，只要两个椎管覆盖板的大致设置方向之间呈角度，并能在两个椎管覆盖板之间形成第一凹部即可。It should be noted that the connection of the two spinal canal covering plates 10 at an angle means that the respective approximate installation directions of the two spinal canal covering plates 10 form an angle. In this embodiment, the spinal canal covering plate 10 is a straight plate, and two straight plates are connected at an angle. Of course, the specific structure of the vertebral canal covering plate 10 is not limited thereto. In other embodiments, the vertebral canal covering plate may not be a straight plate. It is sufficient that the general setting directions of the two vertebral canal covering plates form an angle, and the first recess can be formed between the two vertebral canal covering plates.
如图1至图4所示，在实施例一的脊柱固定组件中，脊柱固定组件还包括关节突连接板20。关节突连接板20为两个，两个关节突连接板20分别设置在两个椎管覆盖板10上。关节突连接板20设置在椎管覆盖板10远离脊柱椎管的一侧并沿远离脊柱椎管的方向延伸。关节突连接板20的上端具有第一关节突结合部21，关节突连接板20的下端具有第二关节突结合部22。脊柱椎体需要进行部分切除或整体摘除的患处椎体的上下相邻的两个生理椎体节段为健康的椎体节段，并且该两个生理椎体节段呈间隔设置。第一关节突结合部21与上方相邻的生理椎体节段的下关节突相接触，第二关节突结合部22与下方相邻的生理椎体节段的上关节突相接触。上述结构可以通过与健康的生理椎体节段的上、下关节突的配合，维持脊柱固定组件理想的空间支撑高度，保证两个健康的生理椎体节段之间能够形成足够的植入物容纳空间。As shown in FIGS. 1 to 4 , in the spinal fixation assembly of Embodiment 1, the spinal fixation assembly further includes an articular process connecting plate 20 . There are two articular process connecting plates 20 , and the two articular process connecting plates 20 are respectively arranged on the two vertebral canal covering plates 10 . The facet connecting plate 20 is arranged on the side of the spinal canal covering plate 10 away from the spinal canal and extends in a direction away from the spinal canal. The upper end of the facet joint plate 20 has a first facet joint part 21 , and the lower end of the facet joint plate 20 has a second facet joint part 22 . The upper and lower adjacent two physiological vertebral body segments of the affected vertebral body that need to be partially resected or totally removed are healthy vertebral body segments, and the two physiological vertebral body segments are arranged at intervals. The first articular process joint part 21 is in contact with the inferior articular process of the upper adjacent physiological vertebral body segment, and the second articular process joint part 22 is in contact with the upper articular process of the lower adjacent physiological vertebral body segment. The above-mentioned structure can maintain the ideal spatial support height of the spinal fixation component by cooperating with the upper and lower articular processes of healthy physiological vertebral body segments, ensuring that sufficient implants can be formed between two healthy physiological vertebral body segments Accommodate space.
需要说明的是，在本实施例中，关节突连接板20为两个，两个关节突连接板20分别设置在两个椎管覆盖板10上。当然，关节突连接板的数量不限于此，在图中未示出的其他实施方式中，当患处椎体的上、下关节突仅一侧切除时，可以仅将关节突连接板设置在两个椎管覆盖板中的一个上。It should be noted that, in this embodiment, there are two articular process connecting plates 20 , and the two articular process connecting plates 20 are respectively arranged on the two vertebral canal covering plates 10 . Of course, the number of facet connecting plates is not limited thereto. In other embodiments not shown in the figures, when only one side of the upper and lower facet joints of the affected vertebral body is resected, the facet connecting plates can only be arranged on both sides. one of the spinal canal covering plates.
如图1和图4所示，在实施例一的脊柱固定组件中，第一关节突结合部21包括设置在关节突连接板20的上端的内侧的第一关节突结合面。第一关节突结合面与上方相邻的健康的生理椎体节段的下关节突的内侧相贴合。第二关节突结合部22包括设置在关节突连接板20的下端的外侧的第二关节突结合面。第二关节突结合面与下方相邻的健康的生理椎体节段的上关节突的外侧相贴合。其中，内侧指的是朝向脊柱椎管的一侧，外侧指的是背离脊柱椎管的一侧。上述结构能够实现关节突连接板20与健康的生理椎体节段的上、下关节突的良好的接触嵌合，模拟了椎体节段的解剖学形态及多个相邻的椎体节段的关节突之间的配合方式，从而使脊柱固定组件与健康的生理椎体节段之间的配合更加牢固可靠。当术后第一关节突结合部21与第二关节突结合部22分别和上下两相邻健康的生理椎体节段的关节突完成融合性骨整合后，上述结构即可提供有力的力学支撑与远期固定效果。As shown in FIG. 1 and FIG. 4 , in the spinal fixation assembly of Embodiment 1, the first facet joint part 21 includes a first facet joint surface disposed on the inner side of the upper end of the facet joint plate 20 . The first articular process joint surface fits with the inner side of the inferior articular process of the upper adjacent healthy physiological vertebral body segment. The second facet joint part 22 includes a second facet joint surface provided on the outer side of the lower end of the facet joint plate 20 . The second articular process joint surface fits with the outer side of the superior articular process of the underlying healthy physiological vertebral body segment. Wherein, the inner side refers to the side facing the spinal canal, and the outer side refers to the side away from the spinal canal. The above-mentioned structure can realize good contact and fit between the articular process connecting plate 20 and the upper and lower articular processes of a healthy physiological vertebral body segment, simulating the anatomical shape of a vertebral body segment and multiple adjacent vertebral body segments The cooperation between the articular processes, so that the cooperation between the spinal fixation components and the healthy physiological vertebral body segments is more firm and reliable. After the first articular process joint 21 and the second articular process joint 22 respectively complete fusion osseointegration with the articular processes of two adjacent healthy physiological vertebral body segments, the above structure can provide strong mechanical support with forward fixed effects.
如图1至图4所示，在实施例一的脊柱固定组件中，脊柱固定组件还包括骨结合板30。骨结合板30为两个，两个骨结合板30分别设置在两个椎管覆盖板10上。骨结合板30与对应的椎管覆盖板10呈角度连接，以在骨结合板30与该椎管覆盖板10之间形成第二凹部。第二凹部的开口方向与第一凹部的开口方向相反。骨结合板30朝向患处椎体的一侧的表面形成骨结合面。当关节突连接板20设置在该椎管覆盖板10上时，关节突连接板20位于第二凹部内。如图3所示，当对患者的患处椎体进行部分切除时，需要切除椎板、棘突、上下关节突，切除之后形成截骨面。骨结合板30的骨结合面与截骨面贴合，这样便于术后形成骨长入，从而实现骨融合，增强固定效果。在本实施例中，骨结合板30上设置有螺钉孔，手术中可以通过螺钉穿过该螺钉孔并与患者被保留的骨质连接，从而实现脊柱固定组件与脊柱的患处椎体之间的初始固定。在本实施例中，骨结合板30为两个，两个骨结合板30分别设置在两个椎管覆盖板10上。当然，骨结合板的数量不限于此，在图中未示出的其他实施方式中，当患处椎体仅一侧切除时，可以仅将骨结合板设置在两个椎管覆盖板中的一个上。As shown in FIGS. 1 to 4 , in the spinal fixation assembly of the first embodiment, the spinal fixation assembly further includes an osseointegration plate 30 . There are two osseointegration plates 30 , and the two osseointegration plates 30 are respectively arranged on the two vertebral canal covering plates 10 . The osseointegration plate 30 is connected to the corresponding spinal canal covering plate 10 at an angle to form a second recess between the osseointegration plate 30 and the spinal canal covering plate 10 . The opening direction of the second recess is opposite to the opening direction of the first recess. The osseointegration plate 30 forms an osseointegration surface on the side facing the affected vertebral body. When the facet connecting plate 20 is placed on the spinal canal covering plate 10, the facet connecting plate 20 is located in the second recess. As shown in FIG. 3 , when a patient's affected vertebral body is partially resected, the lamina, spinous process, and upper and lower articular processes need to be resected, and an osteotomy surface is formed after the resection. The osseointegration surface of the osseointegration plate 30 fits with the osteotomy surface, which facilitates the formation of bone ingrowth after operation, thereby realizing osseointegration and enhancing the fixation effect. In this embodiment, the osseointegration plate 30 is provided with a screw hole, and the screw can pass through the screw hole and connect with the patient's preserved bone during the operation, so as to realize the connection between the spinal fixation component and the affected vertebral body of the spine. initial fix. In this embodiment, there are two osseointegration plates 30 , and the two osseointegration plates 30 are respectively arranged on the two spinal canal covering plates 10 . Of course, the number of osseointegration plates is not limited thereto. In other embodiments not shown in the figures, when only one side of the affected vertebral body is resected, the osseointegration plate can only be set on one of the two vertebral canal covering plates. superior.
需要说明的是，在本实施例中，患处椎体为一节椎体节段，在其他实施例中，如果有两节及两节以上的多节连续椎体节段需要被切除或整体摘除时，脊柱固定组件可以跨越上述多节连续椎体节段，此时，关节突连接板可以跨越两节及两节以上的多节椎体节段，其中，多节椎体节段的整体构成患处椎体，关节突连接板与患处椎体的上下相邻的两个生理椎体节段相配合。位于第一凹部的一侧的骨结合板为多个，多个骨结合板沿同侧的关节突连接板的延伸方向间隔设置，多个骨结合板分别与构成患处椎体的多节椎体节段的截骨面相配合。It should be noted that in this embodiment, the affected vertebral body is one vertebral body segment. In other embodiments, if there are two or more consecutive vertebral body segments that need to be resected or en bloc removed , the spinal fixation component can span the above-mentioned multi-segmented vertebral body segments, and at this time, the articular process connecting plate can span two or more multi-segmented vertebral body segments, wherein the overall composition of the multi-segmented vertebral body segments The affected vertebral body and the articular process connecting plate cooperate with the upper and lower adjacent physiological vertebral body segments of the affected vertebral body. There are multiple osseointegration plates located on one side of the first concave portion, and the plurality of osseointegration plates are arranged at intervals along the extension direction of the facet joint plate on the same side. The segmental osteotomy surfaces match.
在现有技术中，脊柱后路内固定技术通常采用钉棒(椎弓根钉+金属棒)技术，此种技术将脊椎后路的压扭力学载荷通过椎弓根钉完全传递加载到两根金属棒上，容易造成金属棒疲劳损坏。In the prior art, the internal fixation technology of the posterior spine usually adopts the screw rod (pedicle screw + metal rod) technology, which completely transfers the compressive torsion load of the posterior spine to the two pedicle screws through the pedicle screw. On the metal rod, it is easy to cause fatigue damage to the metal rod.
如图1至图4所示，在实施例一的脊柱固定组件中，固定结构包括固定棒40以及第一椎弓根螺钉50。固定棒40的两端分别通过第一椎弓根螺钉50固定在位于患处椎体的上方和下方的两个生理椎体节段上。固定棒40与骨结合板30相配合，以将两个椎管覆盖板10固定在脊柱椎管的后方并与脊柱椎管的前方的患处椎体相对应的位置。当固定棒40通过第一椎弓根螺钉50固定在位于患处椎体的上方和下方的两个生理椎体节段上后，固定棒40能够对骨结合板30进行辅助固定，从而使两个椎管覆盖板10固定得更加牢靠。此外，上述固定棒40与骨结合板30之间存在力的传递，也就是说，两个健康的生理椎体节段的力通过第一椎弓根螺钉50传递至固定棒40上，固定棒40上的力再传递至骨结合板30上，此后，骨结合板30上的力再传递至椎管覆盖板10或关节突连接板20上，从而减小对固定棒40的影响，防止固定棒40疲劳损坏。As shown in FIGS. 1 to 4 , in the spinal fixation assembly of Embodiment 1, the fixation structure includes a fixation rod 40 and a first pedicle screw 50 . Both ends of the fixing rod 40 are respectively fixed on two physiological vertebral body segments located above and below the affected vertebral body through the first pedicle screw 50 . The fixing rod 40 cooperates with the osseointegration plate 30 to fix the two spinal canal covering plates 10 at the rear of the spinal canal and corresponding to the affected vertebral body in front of the spinal canal. After the fixation rod 40 is fixed on the two physiological vertebral body segments above and below the affected vertebral body by the first pedicle screw 50, the fixation rod 40 can assist in fixing the osseointegration plate 30, so that the two The spinal canal covering plate 10 is fixed more firmly. In addition, there is force transmission between the above-mentioned fixing rod 40 and the osseointegration plate 30, that is to say, the force of two healthy physiological vertebral body segments is transmitted to the fixing rod 40 through the first pedicle screw 50, and the fixing rod The force on the osseointegration plate 40 is then transmitted to the osseointegration plate 30. After that, the force on the osseointegration plate 30 is transmitted to the vertebral canal cover plate 10 or the facet joint plate 20, thereby reducing the influence on the fixation rod 40 and preventing fixation. Rod 40 fatigue damage.
需要说明的是，第一椎弓根螺钉50包括螺钉主体及压棒帽。螺钉主体的头部具有沿螺钉主体的径向方向贯通设置的安装槽，安装槽的槽壁上设置有内螺纹。压棒帽的外壁上设置有与内螺纹相适配的外螺纹。当固定棒40穿设在安装槽内后，压棒帽嵌入至安装槽内并与安装槽连接，以将固定棒40锁紧在螺钉主体上，进而使固定棒40通过螺钉主体旋进健康的生理椎体节段上来实现固定。It should be noted that the first pedicle screw 50 includes a screw body and a compression rod cap. The head of the screw body has a mounting groove penetratingly arranged along the radial direction of the screw body, and the groove wall of the mounting groove is provided with an internal thread. The outer wall of the pressing rod cap is provided with an external thread matched with the internal thread. After the fixing rod 40 is installed in the installation groove, the pressing rod cap is inserted into the installation groove and connected with the installation groove to lock the fixing rod 40 on the screw body, and then the fixing rod 40 is screwed into the healthy body through the screw body. On the physiological vertebral body segment to achieve fixation.
如图1至图4所示，在实施例一的脊柱固定组件中，骨结合板30远离椎管覆盖板10的一侧具有能够通过压紧方式进行固定的固定棒结合部31。当固定棒40的两端固定在两个生理椎体节段上后，固定棒40压入固定棒结合部31并将固定棒结合部31压紧固定。在本实施例中，骨结合板30远离椎管覆盖板10的一侧朝向远离脊柱的方向弯折，以形成上述固定棒结合部31。上述结构能够保证固定棒40与骨结合板30之间的配合可靠性。As shown in FIG. 1 to FIG. 4 , in the spinal fixation assembly of the first embodiment, the side of the osseointegration plate 30 away from the spinal canal covering plate 10 has a fixing rod joint portion 31 that can be fixed by compression. After the two ends of the fixing rod 40 are fixed on the two physiological vertebral body segments, the fixing rod 40 is pressed into the fixing rod joint part 31 and the fixing rod joint part 31 is compressed and fixed. In this embodiment, the side of the osseointegration plate 30 away from the spinal canal covering plate 10 is bent in a direction away from the spine to form the above-mentioned fixing rod joint portion 31 . The above structure can ensure the reliability of cooperation between the fixation rod 40 and the osseointegration plate 30 .
需要说明的是，固定棒40与骨结合板30的配合方式不限于此，在其他实施方式中，固定棒与骨结合板之间可以为其他配合方式。例如，骨结合板远离椎管覆盖板的一侧具有固定棒结合部，固定棒结合部与固定棒之间通过焊接连接或者通过3D打印技术直接打印形成一体结构。当固定棒的两端固定在两个生理椎体节段上后，一体连接的固定棒和固定棒结合部、骨结合板压紧固定。It should be noted that the cooperation between the fixation rod 40 and the osseointegration plate 30 is not limited thereto, and in other embodiments, other cooperation methods between the fixation rod and the osseointegration plate can be used. For example, the side of the osseointegration plate away from the vertebral canal covering plate has a fixed rod joint, and the fixed rod joint and the fixed rod are connected by welding or directly printed by 3D printing technology to form an integrated structure. After the two ends of the fixing rod are fixed on the two physiological vertebral body segments, the integrally connected fixing rod, the joint part of the fixing rod and the osseointegration plate are compressed and fixed.
如图1至图4所示，在实施例一的脊柱固定组件中，脊柱固定组件还包括棘突板80。棘突板80连接在两个椎管覆盖板10的连接处并朝向背离两个椎管覆盖板10的方向延伸。棘突板80的上端和下端均设置有棘突结合部81。两个棘突结合部81分别与位于患处椎体的上方和下方的两个生理椎体节段的棘突抵顶配合。脊柱椎体需要进行部分切除或整体摘除的患处椎体的上下相邻的两个生理椎体节段为健康的椎体节段，并且该两个生理椎体节段间隔设置。位于上部的棘突结合部81与上方相邻的健康的生理椎体节段的棘突下缘相接触，位于下部的棘突结合部81与下方相邻的健康的生理椎体节段的棘突上缘相接触。上述结构可以通过对健康的生理椎体节段的棘突的上、下缘的支撑，维持脊柱固定组件理想的空间支撑高度，保证两个健康的生理椎体节段之间能够形成足够的植入物容纳空间。在本实施例中，棘突结合部81为形成在棘突板80的端部的U形槽，该U形槽的开口均朝向健康的生理椎体节段的棘突，健康的生理椎体节段的棘突容纳在U形槽内，从而使棘突结合部81与棘突形成良好的配合。As shown in FIGS. 1 to 4 , in the spinal column fixation assembly of Embodiment 1, the spinal column fixation assembly further includes a spinous process plate 80 . The spinous process plate 80 is connected at the junction of the two spinal canal covering plates 10 and extends away from the two spinal canal covering plates 10 . Both the upper end and the lower end of the spinous process plate 80 are provided with a spinous process joint part 81 . The two spinous process junctions 81 respectively abut and cooperate with the spinous processes of the two physiological vertebral body segments located above and below the affected vertebral body. The upper and lower adjacent two physiological vertebral body segments of the affected vertebral body that need to be partially resected or totally removed are healthy vertebral body segments, and the two physiological vertebral body segments are arranged at intervals. The spinous process junction 81 at the upper part is in contact with the lower edge of the spinous process of the adjacent healthy physiological vertebral body segment above, and the spinous process junction 81 at the lower part is in contact with the spine of the healthy physiological vertebral body segment adjacent below. The upper edges are in contact. The above-mentioned structure can maintain the ideal spatial support height of the spinal fixation component by supporting the upper and lower edges of the spinous processes of the healthy physiological vertebral body segments, and ensure that sufficient implantation can be formed between the two healthy physiological vertebral body segments. Entry storage space. In this embodiment, the spinous process joint portion 81 is a U-shaped groove formed at the end of the spinous process plate 80, and the openings of the U-shaped groove all face the spinous processes of the healthy physiological vertebral body segment, and the healthy physiological vertebral body segment The spinous processes of the section are accommodated in the U-shaped groove, so that the spinous process joint part 81 forms a good fit with the spinous processes.
在实施例一的脊柱固定组件中，脊柱固定组件的椎管覆盖板10、关节突连接板20、第一关节突结合部21、第二关节突结合部22、骨结合板30、棘突板80以及棘突结合部81是使用医用金属材料(钴合金、钛合金、钽合金、镁合金等)通过锻造或铸造或3D打印的方法一体制造的。In the spinal fixation assembly of Embodiment 1, the vertebral canal covering plate 10, the articular process connecting plate 20, the first articular process joint part 21, the second articular process joint part 22, the osseointegration plate 30, and the spinous process plate 80 of the spinal column fixation set And the spinous process joint portion 81 is integrally manufactured by forging or casting or 3D printing using medical metal materials (cobalt alloy, titanium alloy, tantalum alloy, magnesium alloy, etc.).
其中，用于金属材料的3D打印通常采用激光或高能电子束快速成型技术来实现。本项技术属于增才制造技术的一种。3D打印技术与传统的金属切削加工方法不同，它不是在整块的材料(毛坯)上通过去除材料(例如切削加工)以获得最终产品，而是通过将材料一层一层的熔融堆积叠加而得到最终的产品。3D打印所采用的能量源输入包括电能、压缩空气源、热源、紫外光、高能束(激光束、电子束等)，所使用的材料主要有高分子材料、矿物材料、金属材料、陶瓷材料、生物材料(蛋白质、活体细胞、DNA等)。本实用新型提及的激光或高能电子束快速成型技术熔融成型所使用的材料是医用金属，其工作原理是：Among them, 3D printing for metal materials is usually realized by laser or high-energy electron beam rapid prototyping technology. This technology is a kind of additive manufacturing technology. 3D printing technology is different from the traditional metal cutting method. It does not obtain the final product by removing material (such as cutting) on the whole block of material (blank), but by superimposing the material layer by layer. to get the final product. The energy source input used in 3D printing includes electric energy, compressed air source, heat source, ultraviolet light, high-energy beam (laser beam, electron beam, etc.), and the materials used mainly include polymer materials, mineral materials, metal materials, ceramic materials, Biological materials (proteins, living cells, DNA, etc.). The material used in the fusion molding of the laser or high-energy electron beam rapid prototyping technology mentioned in the utility model is medical metal, and its working principle is:
第一步首先在电脑中设计出完整的产品三维模型，具体到本实用新型即是指包含有椎管覆盖板10、关节突连接板20、第一关节突结合部21、第二关节突结合部22、骨结合板30、棘突板80以及棘突结合部81的结构模型；The first step is to design a complete three-dimensional model of the product in the computer. Specifically, the utility model refers to the spinal canal covering plate 10, the articular process connecting plate 20, the first articular process joint part 21, and the second articular process joint. Structural models of part 22, osseointegration plate 30, spinous process plate 80 and spinous process joint part 81;
第二步将设计好的三维模型在分层软件中逐片“切割”成片层文件数据，其每层文件的“切割”厚度可达0.05～0.10mm；The second step is to "cut" the designed 3D model into slice file data piece by piece in the layering software, and the "cut" thickness of each layer file can reach 0.05-0.10mm;
第三步将分层文件顺序输入到激光或高能电子束快速成型设备中，并将所要使用的医用金属粉末装入设备的粉料仓，在设备的工作舱中通常会设置有一个基础平台，未来的产品将会在这个基础平台上逐层累积起来；The third step is to sequentially input the layered files into the laser or high-energy electron beam rapid prototyping equipment, and load the medical metal powder to be used into the powder bin of the equipment. There is usually a basic platform in the working cabin of the equipment. Future products will be accumulated layer by layer on this basic platform;
第四步由铺粉装置在基础平台上铺设一层材料粉末，粉末的厚度与片层文件的厚度大体一致(考虑到熔融后的材料收缩，有时铺粉厚度会略高一些)；The fourth step is to lay a layer of material powder on the foundation platform by the powder spreading device. The thickness of the powder is roughly the same as the thickness of the sheet file (considering the shrinkage of the material after melting, sometimes the thickness of the powder spreading will be slightly higher);
第五步由电脑控制的激光束或高能电子束对粉末层进行扫描并实施选择区域的熔融，根据每一片片层文件数据的设定，电脑控制高能束发射源投射出受到控制的激光束或电子束，在需要熔化的点位使得粉料瞬间达到1800～2000C。高温熔化并随后迅速降温凝固，若干熔化点位连接成片就会得到一个固体片层；而不需要熔化的点位获得的激光或电子束能量较低，粉料不会熔化；当一层扫描完成后铺粉装置再铺设一层新的粉末，重复前述扫描熔融过程，使得第二层片层与第一层片层熔融叠加到一起，由此重复叠加累积就可以得到一个与电脑中设计的三维立体模型一模一样的产品实物；当最后一层片层扫描完成后将产品实体以及包覆在其周围的未熔融的粉末取出，放进专门的回收装置内将粉末除去即可得到完整的产品。The fifth step is to scan the powder layer with a computer-controlled laser beam or high-energy electron beam and implement the melting of the selected area. According to the setting of the file data of each layer, the computer-controlled high-energy beam emission source projects a controlled laser beam or The electron beam makes the powder reach 1800-2000C instantly at the point that needs to be melted. Melting at high temperature and then rapidly cooling and solidifying, a solid sheet will be obtained when several melting points are connected into a sheet; the laser or electron beam energy obtained by the point that does not need to be melted is low, and the powder will not melt; when a layer is scanned After the completion of the powder spreading device, a new layer of powder is laid, and the aforementioned scanning and melting process is repeated, so that the second layer and the first layer are fused and superimposed together, and thus a repeated superposition and accumulation can be obtained. The three-dimensional model is exactly the same as the actual product; when the last layer of sheet scanning is completed, the product entity and the unmelted powder wrapped around it are taken out, and put into a special recovery device to remove the powder to obtain a complete product.
实施例一的脊柱固定组件的设计步骤及制作方法如下：The design steps and manufacturing method of the spinal fixation assembly of Embodiment 1 are as follows:
1、首先使用交互式的医学影像控制系统依据患者的CT或MRI等医学三维断层扫描数据建立患者脊柱病患部位椎体节段(患处椎体)及相邻的健康的生理椎体节段的三维模型；1. First, use the interactive medical image control system to establish the vertebral body segment (affected vertebral body) and the adjacent healthy physiological vertebral body segment of the patient's spinal disease based on the patient's CT or MRI and other medical three-dimensional tomographic scan data. 3D model;
2、按照医学诊断制订的方案将预计被切除的部位从三维模型中剔除；2. According to the plan formulated by the medical diagnosis, the part that is expected to be resected is removed from the three-dimensional model;
3、根据需要填补占位的骨缺损空间设计脊柱固定组件；3. Design spinal fixation components according to the need to fill the space of the occupied bone defect;
4、在设计椎管覆盖板10时应预留出足够的可容纳脊柱椎管的空间；4. When designing the spinal canal covering plate 10, enough space for the spinal canal should be reserved;
5、设计的位于上部的棘突结合部81应与上方相邻的健康生理椎体节段的棘突下缘有良好的接触嵌合或贴合，设计的位于上部的棘突结合部81应与下方相邻的健康生理椎体节段的棘突上缘有良好的接触嵌合或贴合，设计的棘突结合部81应保证棘突结合部81与上、下相邻的健康生理椎体节段的棘突可靠接触后维持理想的空间支撑高度；5. The designed upper spinous process junction 81 should be in good contact with the lower edge of the spinous process of the upper adjacent healthy physiological vertebral segment, and the designed upper spinous process junction 81 should be The upper edge of the spinous process of the adjacent healthy physiological vertebral body segment below has a good contact fit or fit, and the designed spinous process junction 81 should ensure that the spinous process junction 81 is connected to the upper and lower adjacent healthy physiological vertebral bodies. The spinous process of the body segment maintains the ideal space support height after reliable contact;
6、设计的第一关节突结合部21应与上方相邻的健康生理椎体节段的下关节突有良好的接触嵌合或贴合，设计的第二关节突结合部22应与下方相邻的健康生理椎体节段的上关节突有良好的接触嵌合或贴合，第一关节突结合部21与第二关节突结合部22之间的连接部分(关节突连接板20)应保证第一关节突结合部21、第二关节突结合部22分别与上、下相邻健康生理椎体节段的下、上关节突可靠接触后维持理想的空间支撑高度；6. The designed first articular process junction 21 should have good contact fit or fit with the inferior articular process of the adjacent healthy physiological vertebral body segment above, and the designed second articular process junction 22 should be similar to the lower articular process. The upper articular process of the adjacent healthy physiological vertebral body segment has good contact fit or fit, and the connection part (facet joint plate 20) between the first facet joint part 21 and the second facet joint part 22 should be Ensure that the first facet joint 21 and the second facet joint 22 are in reliable contact with the lower and upper facets of the upper and lower adjacent healthy physiological vertebral body segments respectively to maintain an ideal space support height;
7、依据上、下相邻的健康生理椎体节段在术中将要安装的第一椎弓根螺钉50位置设计出固定棒40的空间位置及长短尺寸；7. Design the spatial position and length of the fixing rod 40 according to the position of the first pedicle screw 50 to be installed in the upper and lower adjacent healthy physiological vertebral body segments;
8、根据术中截骨的位置设计出骨结合板30，骨结合板30的骨结合面应能很好的贴合于截骨后保留的宿主骨界面以便于术后形成骨长入而实现骨融合；8. The osseointegration plate 30 is designed according to the position of the osteotomy during the operation. The osseointegration surface of the osseointegration plate 30 should be well fitted to the host bone interface retained after the osteotomy so as to facilitate postoperative bone ingrowth. bone fusion;
9、在上述设计完成后，依据设计的三维文件经工艺编程后可直接由数控加工中心对金属毛坯进行加工或者通过3D打印方法得到含有椎管覆盖板10、关节突连接板20、第一关节突结合部21、第二关节突结合部22、骨结合板30、棘突板80以及棘突结合部81的结构的半成品，在经过喷涂、烧结以及必要的后续机加工即可得到最终产品。9. After the above design is completed, the metal blank can be directly processed by the CNC machining center after the process programming according to the three-dimensional file of the design, or the 3D printing method can be used to obtain the spinal canal cover plate 10, the articular process connecting plate 20, the first joint Semi-finished products of the structure of the articular process joint 21, the second articular process joint 22, the osseointegration plate 30, the spinous process plate 80 and the spinous process joint 81 can be finished after spraying, sintering and necessary subsequent machining.
如图5所示，实施例二的脊柱固定组件与实施例一的主要区别在于，两个椎管覆盖板10均为弧形板，两个弧形板呈角度连接，以在两个弧形板之间形成第一凹部。在单个弧形板的横截面上，可以将该弧形板的两个侧边沿对应的位置之间的连线的延伸方向定义为该弧形板的大致设置方向。因此，此时两个弧形板呈角度连接可以理解为，各弧形板的上述连线之间呈角度设置。此外，实施例二的脊柱固定组件的其他结构和工作原理与实施例一基本相同，在此不再赘述。As shown in Figure 5, the main difference between the spinal fixation assembly of Embodiment 2 and Embodiment 1 is that the two spinal canal covering plates 10 are both arc-shaped plates, and the two arc-shaped plates are connected at an angle so that the two arc-shaped A first recess is formed between the plates. On the cross section of a single arc-shaped plate, the extending direction of the line between the corresponding positions of the two side edges of the arc-shaped plate can be defined as the general arrangement direction of the arc-shaped plate. Therefore, at this time, the connection of the two arc-shaped plates at an angle can be understood as that the above-mentioned connecting lines of the arc-shaped plates are arranged at an angle. In addition, other structures and working principles of the spinal fixation assembly of the second embodiment are basically the same as those of the first embodiment, and will not be repeated here.
如图6所示，实施例三的脊柱固定组件与实施例一的主要区别在于，两个椎管覆盖板10中的一个为平直板，另一个为弧形板，平直板与弧形板呈角度连接，以在平直板与弧形板之间形成第一凹部。在弧形板的横截面上，可以将该弧形板的两个侧边沿对应的位置之间的连线的延伸方向定义为该弧形板的大致设置方向。因此，此时平直板与弧形板呈角度连接可以理解为，弧形板的上述连线与平直板之间呈角度设置。此外，实施例三的脊柱固定组件的其他结构和工作原理与实施例一基本相同，在此不再赘述。As shown in Figure 6, the main difference between the spinal fixation assembly of Embodiment 3 and Embodiment 1 is that one of the two vertebral canal covering plates 10 is a straight plate, and the other is an arc-shaped plate, and the straight plate and the arc-shaped plate form a Angled connection to form a first recess between the straight plate and the curved plate. On the cross-section of the arc-shaped plate, the extending direction of the line between the corresponding positions of the two side edges of the arc-shaped plate can be defined as the general arrangement direction of the arc-shaped plate. Therefore, at this time, the angle connection between the straight plate and the arc-shaped plate can be understood as that the above-mentioned connecting line of the arc-shaped plate and the straight plate are arranged at an angle. In addition, other structures and working principles of the spinal fixation assembly of the third embodiment are basically the same as those of the first embodiment, and will not be repeated here.
如图7至图9所示，实施例四的脊柱固定组件与实施例一的主要区别在于，棘突板80上设置有第一多孔层101，椎管覆盖板10上设置有缝合孔90。其中，第一多孔层101为三维贯通的第一通孔结构，该第一通孔结构的孔径为150μm至2000μm。在术中可以针对情况选择将棘间韧带、棘上韧带及其他相近软组织覆盖于第一多孔层101上，以便将来相关软组织能长入第一多孔层101的孔隙内形成软组织与植入物的融合。此外，在术中还可以针对情况选择将棘间韧带、棘上韧带及其他相近软组织缝合于缝合孔90中，以便将来相关软组织能较好地形成软组织附着。当然，第一多孔层101和缝合孔90的设置位置不限于此，在其他实施方式中，第一多孔层和缝合孔可以设置在其他部位上。此外，实施例二的脊柱固定组件的其他结构和工作原理与实施例一基本相同，在此不再赘述。As shown in FIGS. 7 to 9 , the main difference between the spinal fixation assembly of Embodiment 4 and Embodiment 1 is that the spinous process plate 80 is provided with a first porous layer 101 , and the spinal canal covering plate 10 is provided with suture holes 90 . Wherein, the first porous layer 101 is a three-dimensionally connected first through-hole structure, and the pore diameter of the first through-hole structure is 150 μm to 2000 μm. During the operation, the interspinous ligament, supraspinous ligament and other similar soft tissues can be selected to cover the first porous layer 101, so that the relevant soft tissues can grow into the pores of the first porous layer 101 to form soft tissues and implant in the future. fusion of things. In addition, the interspinous ligament, supraspinous ligament and other similar soft tissues can also be sutured in the suture hole 90 according to the situation during the operation, so that the relevant soft tissues can better form soft tissue attachment in the future. Of course, the locations where the first porous layer 101 and the sewing holes 90 are arranged are not limited thereto, and in other embodiments, the first porous layer and the sewing holes can be arranged at other locations. In addition, other structures and working principles of the spinal fixation assembly of the second embodiment are basically the same as those of the first embodiment, and will not be repeated here.
需要说明的是，图7示出了两个生理椎体节段之间为人体生理椎体时(即脊柱固定组件前方为人体生理椎体时)脊柱固定组件与脊柱相配合的结构示意图，图8示出了两个生理椎体节段之间为钛笼时(即脊柱固定组件前方为设置在上下两个生理椎体节段之间的钛笼时)脊柱固定组件与脊柱相配合的分解结构示意图，图9示出了两个生理椎体节段之间为钛笼时(即脊柱固定组件前方为设置在上下两个生理椎体节段之间的钛笼时)脊柱固定组件与脊柱相配合的结构示意图。如图8和图9所示，脊柱的患处椎体需要在术中整体摘除，并植入钛笼进行重建。当然，在其他实施方式中，也可以在整体摘除患处椎体的位置植入人工椎体假体继续重建。It should be noted that Fig. 7 shows a schematic diagram of the structure of the spinal fixation assembly and the spine when there is a human physiological vertebral body between two physiological vertebral body segments (that is, when the spinal column fixation assembly is in front of a human physiological vertebral body). 8 shows the decomposition of the spinal fixation assembly and the spine when there is a titanium cage between the two physiological vertebral body segments (that is, when the front of the spinal fixation assembly is a titanium cage arranged between the upper and lower physiological vertebral body segments) Structural schematic diagram, Fig. 9 shows when there is a titanium cage between the two physiological vertebral body segments (that is, when the front of the spinal fixation assembly is a titanium cage arranged between the upper and lower two physiological vertebral body segments) the spinal fixation assembly and the spine Compatible structural diagram. As shown in Figure 8 and Figure 9, the affected vertebral body of the spine needs to be removed as a whole during the operation and implanted with a titanium cage for reconstruction. Of course, in other embodiments, an artificial vertebral body prosthesis can also be implanted at the position where the affected vertebral body is completely removed to continue reconstruction.
如图10和图11所示，实施例五的脊柱固定组件与实施例一的主要区别在于，棘突板80连接在两个椎管覆盖板10的连接处并朝向背离两个椎管覆盖板10的方向延伸，并且棘突板80的上下两端不与健康的生理椎体节段相接触。此时，棘突板80用于模拟椎体节段的棘突的解剖学形态。棘突板80上设置有第一多孔层101，第一多孔层101为三维贯通的第一通孔结构，该第一通孔结构的孔径为150μm至2000μm。在术中可以针对情况选择将棘间韧带、棘上韧带及其他相近软组织覆盖于第一多孔层101上，以便将来相关软组织能长入第一多孔层101的孔隙内形成软组织与植入物的融合。此外，实施例五的脊柱固定组件的其他结构和工作原理与实施例一基本相同，在此不再赘述。As shown in FIGS. 10 and 11 , the main difference between the spinal fixation assembly of Embodiment 5 and Embodiment 1 is that the spinous process plate 80 is connected at the junction of the two spinal canal covering plates 10 and faces away from the two spinal canal covering plates 10 , and the upper and lower ends of the spinous process plate 80 are not in contact with healthy physiological vertebral body segments. At this time, the spinous process plate 80 is used to simulate the anatomical shape of the spinous processes of the vertebral body segment. The spinous process plate 80 is provided with a first porous layer 101 , the first porous layer 101 is a three-dimensional through-hole structure, and the diameter of the first through-hole structure is 150 μm to 2000 μm. During the operation, the interspinous ligament, supraspinous ligament and other similar soft tissues can be selected to cover the first porous layer 101, so that the relevant soft tissues can grow into the pores of the first porous layer 101 to form soft tissues and implant in the future. fusion of things. In addition, other structures and working principles of the spinal fixation assembly of the fifth embodiment are basically the same as those of the first embodiment, and will not be repeated here.
实施例五的脊柱固定组件的设计步骤及制作方法如下：The design steps and manufacturing method of the spinal fixation assembly of Embodiment 5 are as follows:
1、首先使用交互式的医学影像控制系统依据患者的CT或MRI等医学三维断层扫描数据建立患者脊柱的患处椎体及相邻的健康的生理椎体节段的三维模型；1. First, use the interactive medical image control system to establish a three-dimensional model of the affected vertebral body of the patient's spine and the adjacent healthy physiological vertebral body segments based on the patient's CT or MRI and other medical three-dimensional tomographic scanning data;
2、按照医学诊断制订的方案将预计被切除的部位从三维模型中剔除；2. According to the plan formulated by the medical diagnosis, the part that is expected to be resected is removed from the three-dimensional model;
3、根据需要填补占位的骨缺损空间设计脊柱固定组件；3. Design spinal fixation components according to the need to fill the space of the occupied bone defect;
4、在设计椎管覆盖板10时应预留出足够的可容纳椎管的空间；4. When designing the spinal canal covering plate 10, enough space for accommodating the spinal canal should be reserved;
5、设计的第一关节突结合部应与上方相邻的健康生理椎体节段的下关节突有良好的接触嵌合或贴合，设计的第二关节突结合部应与下方相邻的健康生理椎体节段的上关节突有良好的接触嵌合或贴合，第一关节突结合部与第二关节突结合部之间的连接部分(关节突连接板20)应保证第一关节突结合部、第二关节突结合部分别与上、下相邻健康生理椎体节段的下、上关节突可靠接触后维持理想的空间支撑高度；5. The designed first articular process junction should have good contact fit or fit with the inferior articular process of the upper adjacent healthy physiological vertebral body segment, and the designed second articular process junction should be in contact with the lower adjacent articular process. The upper articular process of the healthy physiological vertebral body segment has good contact fit or fit, and the connecting part (facet joint plate 20) between the first articular process joint and the second articular process joint should ensure that the first joint The articular process junction and the second articular process junction are in reliable contact with the lower and upper articular processes of the upper and lower adjacent healthy physiological vertebral body segments respectively to maintain an ideal space support height;
6、棘突板80上设置有第一多孔层101，该第一多孔层101用以棘间韧带、棘上韧带及其他相近软组织的覆盖融合；6. The spinous process plate 80 is provided with a first porous layer 101, the first porous layer 101 is used to cover and fuse the interspinous ligament, supraspinous ligament and other similar soft tissues;
7、依据上、下相邻的健康椎体节段在术中将要安装的第一椎弓根螺钉50位置设计出固定棒40的空间位置及长短尺寸；7. Design the spatial position and length of the fixation rod 40 according to the position of the first pedicle screw 50 to be installed in the upper and lower adjacent healthy vertebral body segments;
8、根据术中截骨的位置设计出骨结合板30，骨结合板30的骨结合面应能很好的贴合于截骨后保留的宿主骨界面以便于术后形成骨长入而实现骨融合；8. The osseointegration plate 30 is designed according to the position of the osteotomy during the operation. The osseointegration surface of the osseointegration plate 30 should be well fitted to the host bone interface retained after the osteotomy so as to facilitate postoperative bone ingrowth. bone fusion;
9、在上述设计完成后，依据设计的三维文件经工艺编程后可直接由数控加工中心对金属毛坯进行加工或者通过3D打印方法得到含有椎管覆盖板10、关节突连接板20、第一关节突结合部、第二关节突结合部、骨结合板30以及棘突板80的结构的半成品，在经过喷涂、烧结以及必要的后续机加工即可得到最终产品。9. After the above design is completed, the metal blank can be directly processed by the CNC machining center after the process programming according to the three-dimensional file of the design, or the 3D printing method can be used to obtain the spinal canal cover plate 10, the articular process connecting plate 20, the first joint The semi-finished products of the structure of the articular process joint part, the second articular process joint part, the osseointegration plate 30 and the spinous process plate 80 can be finished products after spraying, sintering and necessary subsequent machining.
如图12和图13所示，实施例六的脊柱固定组件与实施例五的主要区别在于，固定结构还包括锁合结构60。锁合结构60包括安装柱61与压棒螺帽62。其中，安装柱61一体设置在固定棒结合部31上。安装柱61具有沿固定棒的延伸方向贯通设置的通槽611。通槽611的槽壁上设置有内螺纹。压棒螺帽62的外壁上设置有与内螺纹相适配的外螺纹。当固定棒穿设在通槽611内后，压棒螺帽62嵌入至通槽611内并与通槽611通过外螺纹和内螺纹连接，以将固定棒锁紧在安装柱61上。上述锁合结构60能够将固定棒与骨结合板30固定在一起，是两者配合更加牢固。此外，在本实施例中，棘突板80和椎管覆盖板10上均设置有缝合孔90，在术中可以针对情况选择将棘间韧带、棘上韧带及其他相近软组织缝合于缝合孔90中，以便将来相关软组织能较好地形成软组织附着。此外，实施例六的脊柱固定组件的其他结构和工作原理与实施例五基本相同，在此不再赘述。As shown in FIGS. 12 and 13 , the main difference between the spinal fixation assembly of the sixth embodiment and the fifth embodiment is that the fixing structure further includes a locking structure 60 . The locking structure 60 includes a mounting column 61 and a pressing bar nut 62 . Wherein, the mounting column 61 is integrally disposed on the fixing rod joint portion 31 . The mounting post 61 has a through slot 611 provided through along the extending direction of the fixing bar. Internal threads are provided on the groove wall of the through groove 611 . The outer wall of the pressing rod nut 62 is provided with an external thread matching the internal thread. After the fixing rod is passed through the through groove 611 , the pressing rod nut 62 is inserted into the through groove 611 and connected with the through groove 611 through an external thread and an internal thread, so as to lock the fixing rod on the mounting post 61 . The above-mentioned locking structure 60 can fix the fixing rod and the osseointegration plate 30 together, so that the cooperation between the two is more firm. In addition, in this embodiment, the spinous process plate 80 and the spinal canal covering plate 10 are provided with suture holes 90, and the interspinous ligament, supraspinous ligament and other similar soft tissues can be sutured in the suture holes 90 according to the situation during the operation. , so that the relevant soft tissues can better form soft tissue attachment in the future. In addition, other structures and working principles of the spinal fixation assembly of the sixth embodiment are basically the same as those of the fifth embodiment, and will not be repeated here.
实施例六的脊柱固定组件的设计步骤及制作方法如下：The design steps and manufacturing method of the spinal fixation assembly of Embodiment 6 are as follows:
1、首先使用交互式的医学影像控制系统依据患者的CT或MRI等医学三维断层扫描数据建立患者脊柱患处椎体及相邻的健康的生理椎体节段的三维模型；1. First, use the interactive medical image control system to establish a three-dimensional model of the affected vertebral body of the patient's spine and the adjacent healthy physiological vertebral body segments based on the patient's CT or MRI and other medical three-dimensional tomographic scan data;
2、按照医学诊断制订的方案将预计被切除的部位从三维模型中剔除；2. According to the plan formulated by the medical diagnosis, the part that is expected to be resected is removed from the three-dimensional model;
3、根据需要填补占位的骨缺损空间设计脊柱固定组件；3. Design spinal fixation components according to the need to fill the space of the occupied bone defect;
4、在设计椎管覆盖板10时应预留出足够的可容纳椎管的空间；4. When designing the spinal canal covering plate 10, enough space for accommodating the spinal canal should be reserved;
5、设计的第一关节突结合部21应与上方相邻的健康生理椎体节段的下关节突有良好的接触嵌合或贴合，设计的第二关节突结合部22应与下方相邻的健康生理椎体节段的上关节突有良好的接触嵌合或贴合，第一关节突结合部21与第二关节突结合部22之间的连接部分(关节突连接板20)应保证第一关节突结合部21、第二关节突结合部22分别与上、下相邻健康生理椎体节段的下、上关节突可靠接触后维持理想的空间支撑高度；5. The designed first articular process junction 21 should have good contact fit or fit with the inferior articular process of the adjacent healthy physiological vertebral body segment above, and the designed second articular process junction 22 should be similar to the lower articular process. The upper articular process of the adjacent healthy physiological vertebral body segment has good contact fit or fit, and the connection part (facet joint plate 20) between the first facet joint part 21 and the second facet joint part 22 should be Ensure that the first facet joint 21 and the second facet joint 22 are in reliable contact with the lower and upper facets of the upper and lower adjacent healthy physiological vertebral body segments respectively to maintain an ideal space support height;
6、棘突板80和椎管覆盖板10上设置有缝合孔90，该缝合孔90用以棘间韧带、棘上韧带及其他相近软组织的缝合；6. The spinous process plate 80 and the spinal canal covering plate 10 are provided with a suture hole 90, which is used for suturing the interspinous ligament, supraspinous ligament and other similar soft tissues;
7、依据上、下相邻的健康椎体节段在术中将要安装的第一椎弓根螺钉位置设计出固定棒的空间位置及长短尺寸；7. According to the position of the first pedicle screw to be installed in the upper and lower adjacent healthy vertebral body segments during the operation, design the spatial position and length of the fixation rod;
8、依据术中固定棒与骨结合板30的配合位置设计出锁合结构60的具体位置；8. Design the specific position of the locking structure 60 according to the matching position of the fixation rod and the osseointegration plate 30 during the operation;
9、根据术中截骨的位置设计出骨结合板30，骨结合板30的骨结合面应能很好的贴合于截骨后保留的宿主骨界面以便于术后形成骨长入而实现骨融合；9. The osseointegration plate 30 is designed according to the position of the osteotomy during the operation. The osseointegration surface of the osseointegration plate 30 should be well fitted to the host bone interface retained after the osteotomy so as to facilitate postoperative bone ingrowth. bone fusion;
10、在上述设计完成后，依据设计的三维文件经工艺编程后可直接由数控加工中心对金属毛坯进行加工或者通过3D打印方法得到含有椎管覆盖板10、关节突连接板20、第一关节突结合部21、第二关节突结合部22、骨结合板30以及棘突板80的结构的半成品，在经过喷涂、烧结以及必要的后续机加工即可得到最终产品。10. After the above-mentioned design is completed, the metal blank can be directly processed by the CNC machining center after process programming according to the three-dimensional file of the design, or the 3D printing method can be used to obtain the spinal canal covering plate 10, the articular process connecting plate 20, the first joint The semi-finished products of the structure of the articular process joint 21, the second articular process joint 22, the osseointegration plate 30 and the spinous process plate 80 can be finished products after spraying, sintering and necessary follow-up machining.
如图14所示，实施例七的脊柱固定组件与实施例六的主要区别在于，棘突板80上设置有第一多孔层101，椎管覆盖板10上设置有第二多孔层102，第一多孔层101为三维贯通的第一通孔结构，该第一通孔结构的孔径为150μm至2000μm，第二多孔层102为三维贯通的第二通孔结构，该第二通孔结构的孔径为150μm至2000μm。其中，上述第一通孔结构与第二通孔结构的孔径均选择为150μm至2000μm是因为经动物实验及临床验证证明处于这一尺寸范围的孔径有利于周围软组织细胞长入而形成牢固的软组织融合。因此，在术中可以针对情况选择将棘间韧带、棘上韧带及其他相近软组织覆盖于第一多孔层101和第二多孔层102上，以便将来相关软组织能长入第一多孔层101和第二多孔层102的孔隙内形成软组织与植入物的融合。此外，实施例七的脊柱固定组件的其他结构和工作原理与实施例六基本相同，在此不再赘述。As shown in FIG. 14 , the main difference between the spinal fixation assembly of the seventh embodiment and the sixth embodiment is that the spinous process plate 80 is provided with a first porous layer 101 , and the spinal canal covering plate 10 is provided with a second porous layer 102 . The first porous layer 101 is a three-dimensional through-hole structure with a pore diameter of 150 μm to 2000 μm, and the second porous layer 102 is a three-dimensional through-hole structure with a second through-hole structure. The pore size of the structures ranges from 150 μm to 2000 μm. Among them, the pore diameters of the above-mentioned first through-hole structure and the second through-hole structure are selected to be 150 μm to 2000 μm because animal experiments and clinical verification prove that the pore diameters in this size range are conducive to the growth of surrounding soft tissue cells to form firm soft tissue fusion. Therefore, the interspinous ligament, supraspinous ligament, and other similar soft tissues can be selected to cover the first porous layer 101 and the second porous layer 102 according to the situation during the operation, so that the relevant soft tissues can grow into the first porous layer in the future. 101 and the pores of the second porous layer 102 form the fusion of the soft tissue and the implant. In addition, other structures and working principles of the spinal fixation assembly of the seventh embodiment are basically the same as those of the sixth embodiment, and will not be repeated here.
需要说明的是，在本实施例中，第二多孔层102设置在椎管覆盖板10背离脊柱椎管的外表面上，椎管覆盖板10朝向脊柱椎管的内表面为光滑的实体金属表面。上述结构使第二多孔层102仅设置在背向椎内神经的外侧，而椎管覆盖板10的内侧(即朝向脊髓神经系统的椎管内壁)则设计为光滑表面以避免伤及脊髓神经。It should be noted that, in this embodiment, the second porous layer 102 is disposed on the outer surface of the spinal canal covering plate 10 away from the spinal canal, and the inner surface of the spinal canal covering plate 10 facing the spinal canal is smooth solid metal surface. The above-mentioned structure makes the second porous layer 102 only be arranged on the outer side facing away from the intraspinal nerve, while the inner side of the spinal canal covering plate 10 (that is, the inner wall of the spinal canal facing the spinal nervous system) is designed as a smooth surface to avoid injury to the spinal nerve. .
如图15至图17所示，实施例八的脊柱固定组件与实施例一的主要区别在于，固定结构还包括第二椎弓根螺钉70。骨结合板30上设置有用于穿设第二椎弓根螺钉70的螺钉孔32。固定棒40和骨结合板30通过第二椎弓根螺钉70固定在患处椎体上。在本实施例中，患处椎体为人体生理椎体，固定棒40、骨结合板30通过第二椎弓根螺钉70固定在人体生理椎体的截骨面上，这样可以使固定棒40与骨结合板30配合更加牢固。As shown in FIGS. 15 to 17 , the main difference between the spinal fixation assembly of the eighth embodiment and the first embodiment is that the fixation structure further includes a second pedicle screw 70 . The osseointegration plate 30 is provided with a screw hole 32 for passing the second pedicle screw 70 . The fixation rod 40 and the osseointegration plate 30 are fixed on the affected vertebral body through the second pedicle screw 70 . In the present embodiment, the affected vertebral body is a physiological vertebral body of a human body, and the fixing rod 40 and the osseointegration plate 30 are fixed on the osteotomy surface of the physiological vertebral body of a human body by the second pedicle screw 70, so that the fixing rod 40 can be connected with the The osseointegration plate 30 fits more firmly.
需要说明的是，第二椎弓根螺钉70包括螺钉主体及压棒帽。螺钉主体的头部具有沿螺钉主体的径向方向贯通设置的安装槽，安装槽的槽壁上设置有内螺纹。压棒帽的外壁上设置有与内螺纹相适配的外螺纹。当固定棒40穿设在安装槽内后，压棒帽嵌入至安装槽内并与安装槽连接，以将固定棒40锁紧在螺钉主体上，进而使固定棒40通过螺钉主体旋进人体生理椎体的截骨面上来实现固定。此外，如果脊柱的患处椎体需要在术中整体摘除，可以植入人工椎体假体进行重建，此时，固定棒和骨结合板通过第二椎弓根螺钉固定在两个生理椎体节段之间的人工椎体假体上。It should be noted that the second pedicle screw 70 includes a screw body and a compression rod cap. The head of the screw body has a mounting groove penetratingly arranged along the radial direction of the screw body, and the groove wall of the mounting groove is provided with an internal thread. The outer wall of the pressing rod cap is provided with an external thread matched with the internal thread. After the fixing rod 40 is installed in the installation groove, the pressing rod cap is inserted into the installation groove and connected with the installation groove to lock the fixing rod 40 on the screw body, and then the fixing rod 40 is screwed into the human body through the screw body. The osteotomy surface of the vertebral body is used for fixation. In addition, if the affected vertebral body of the spine needs to be removed as a whole during the operation, artificial vertebral body prosthesis can be implanted for reconstruction. At this time, the fixation rod and osseointegration plate are fixed on the two physiological vertebral body segments by the second pedicle screw. The artificial vertebral prosthesis between the segments.
如图17所示，在实施例八的脊柱固定组件中，第一关节突结合部21和第二关节突结合部22为三维贯通的第一多孔通孔结构，该第一多孔通孔结构的孔径为150μm至1200μm。棘突结合部81为三维贯通的第二多孔通孔结构，该第二多孔通孔结构的孔径为150μm至1200μm。骨结合板30朝向患处椎体的一侧设置有第三多孔层103，第三多孔层103为三维贯通的第三通孔结构，该第三通孔结构的孔径为150μm至1200μm。上述结构构成了脊柱固定组件与人体骨的骨质相贴合的接触面即骨融合层，该骨融合层为含有微小孔隙的多孔层，该多孔层的孔径设置为150μm至1200μm是因为经动物实验及临床验证证明这一范围的孔径有利于骨细胞长入多孔层而形成牢固的骨融合。上述多孔层可以通过以下工艺成型：As shown in Figure 17, in the spinal fixation assembly of the eighth embodiment, the first articular process joint part 21 and the second articular process joint part 22 are three-dimensionally penetrated first porous through-hole structures, and the first porous through-holes The structure has a pore size ranging from 150 μm to 1200 μm. The spinous process junction 81 is a three-dimensionally penetrated second porous through-hole structure, and the pore diameter of the second porous through-hole structure is 150 μm to 1200 μm. The osseointegration plate 30 is provided with a third porous layer 103 on the side facing the affected vertebral body. The third porous layer 103 is a three-dimensional through-hole structure with a pore diameter of 150 μm to 1200 μm. The above-mentioned structure constitutes the contact surface between the spinal fixation component and the bone of the human body, that is, the bone fusion layer. The bone fusion layer is a porous layer containing tiny pores. Experiments and clinical verification have proved that the pore size in this range is conducive to the growth of bone cells into the porous layer to form a firm bone fusion. The above-mentioned porous layer can be formed by the following process:
骨融合层为由金属颗粒烧结而形成的含有微小孔隙的多孔层，该骨融合层一侧牢固的烧结在各与人体骨相贴合的部件朝向人体骨一侧的表面，该骨融合层另一侧则将在手术后紧密贴合于与之相对应的人体骨的表面，以便于日后形成骨细胞的长入而实现骨融合效果，该骨融合层其厚度在0.3～5mm之间，该由金属颗粒烧结而形成的骨融合层所含有的微小孔隙的孔径在0.01～1.5mm之间。因此，如果上述骨融合层采用金属颗粒烧结的工艺方法进行表面处理形成，则各与人体骨相贴合的部件在成型时需要预留出烧结材料的厚度；The bone fusion layer is a porous layer containing tiny pores formed by sintering metal particles. One side of the bone fusion layer is firmly sintered on the surface of each component that fits with the human bone facing the human bone. The other side of the bone fusion layer is The side will be closely attached to the surface of the corresponding human bone after the operation, so as to facilitate the growth of bone cells in the future and achieve the effect of bone fusion. The thickness of the bone fusion layer is between 0.3 and 5mm. The pore size of the tiny pores contained in the bone fusion layer formed by sintering the metal particles is between 0.01mm and 1.5mm. Therefore, if the above-mentioned bone fusion layer is formed by surface treatment by sintering metal particles, the thickness of the sintered material needs to be reserved for each part that fits with the human body bone during molding;
骨融合层为由3D打印技术而形成的含有微小孔隙的多孔层，该骨融合层设置于各与人体骨相贴合的部件朝向人体骨一侧的表面，由于采用3D打印技术制作脊柱固定组件时，除去第二椎弓根螺钉70和固定棒40外其他各结构均可一体打印成型，因此骨融合层与上述各结构为一个整体，该骨融合层将在手术后紧密贴合于与之相对应的人体骨的表面，以便于日后形成骨细胞的长入而实现骨融合效果，该骨融合层其厚度在0.3～5mm之间，该由3D打印技术而形成的含有微小孔隙的融合层所含有的微小孔隙的孔径在0.1～1.5mm之间。因此，如果上述骨融合层采用3D打印技术进行加工时，则脊柱固定组件的各部件在设计3D打印文件时应加入骨融合层结构设计。The bone fusion layer is a porous layer containing tiny pores formed by 3D printing technology. , except for the second pedicle screw 70 and the fixation rod 40, other structures can be integrally printed and formed, so the bone fusion layer is integrated with the above-mentioned structures, and the bone fusion layer will be closely attached to the corresponding structure after operation. Corresponding to the surface of human bone, in order to facilitate the growth of bone cells in the future to achieve the effect of bone fusion, the thickness of the bone fusion layer is between 0.3 and 5mm, and the fusion layer containing tiny pores formed by 3D printing technology is formed. The pore diameter of the contained tiny pores is between 0.1mm and 1.5mm. Therefore, if the above-mentioned bone fusion layer is processed by 3D printing technology, the structural design of the bone fusion layer should be included in the design of the 3D printing files for each component of the spinal fixation assembly.
此外，脊柱固定组件与人体骨相贴合的接触面均设置的骨融合层不限于多孔层，在其他实施方式中，骨融合层可以为高温喷涂于各接触面上的金属粗糙表面，以便于日后骨细胞可以与该金属粗糙表面形成嵌入式骨结合，该金属粗糙表面层其厚度在0.05～2mm之间。因此，如果上述骨融合层采用高温喷涂的工艺方法进行表面处理形成，则各与人体骨相贴合的部件在成型时需要预留出涂层厚度。In addition, the bone fusion layer provided on the contact surface of the spinal fixation component and the human body bone is not limited to a porous layer. In other embodiments, the bone fusion layer can be a metal rough surface sprayed on each contact surface at high temperature, so that it can be used in the future. Osteocytes can form embedded osseointegration with the metal rough surface, and the thickness of the metal rough surface layer is between 0.05-2 mm. Therefore, if the above-mentioned bone fusion layer is formed by surface treatment using a high-temperature spraying process, each component that fits with the human body bone needs to reserve a coating thickness during molding.
需要说明的是，实施例八的脊柱固定组件的其他结构和工作原理与实施例一基本相同，在此不再赘述。It should be noted that other structures and working principles of the spinal fixation assembly in the eighth embodiment are basically the same as those in the first embodiment, and will not be repeated here.
如图18所示，实施例九的脊柱固定组件与实施例八的主要区别在于，位于第一凹部的一侧的骨结合板30为多个，多个骨结合板30沿同侧的关节突连接板20的延伸方向间隔设置，并且该关节突连接板20位于相邻的两个骨结合板30之间的部分设置有神经根通道避让缺口23。在本实施例中，有两节及两节以上的多节连续椎体节段需要被切除或整体摘除，因此，脊柱固定组件可以跨越上述多节连续椎体节段。此时，关节突连接板20可以跨越两节及两节以上的多节椎体节段，其中，多节椎体节段的整体构成患处椎体，关节突连接板20与患处椎体的上下相邻的两个生理椎体节段相配合。多个骨结合板30分别与构成患处椎体的多节椎体节段的截骨面相配合。骨结合板30的数量视前方对应的椎体数量与需求而定，在关节突连接板20相应位置预留出神经根通道避让缺口23，从而避免关节突连接板20压迫干扰神经根的外延通道。As shown in Figure 18, the main difference between the spinal fixation assembly of Embodiment 9 and Embodiment 8 is that there are multiple osseointegration plates 30 on one side of the first concave portion, and multiple osseointegration plates 30 are positioned along the same side of the articular process. The extension direction of the connecting plates 20 is arranged at intervals, and the part of the articular process connecting plates 20 between two adjacent osseointegration plates 30 is provided with a nerve root channel avoidance gap 23 . In this embodiment, there are two or more multiple consecutive vertebral body segments that need to be resected or removed as a whole, therefore, the spinal fixation component can span the above multiple consecutive vertebral body segments. At this time, the articular process connecting plate 20 can span two or more multi-segmented vertebral body segments, wherein the whole of the multi-segmented vertebral body segments constitutes the affected vertebral body, and the facet facet connecting plate 20 is connected with the upper and lower sides of the affected vertebral body. The adjacent two physiological vertebral segments match. A plurality of osseointegration plates 30 are matched with the osteotomy surfaces of the multi-segmented vertebral body segments constituting the affected vertebral body. The number of osseointegration plates 30 depends on the number and needs of the corresponding vertebral bodies in front, and the nerve root channel avoidance gap 23 is reserved at the corresponding position of the facet joint plate 20, so as to prevent the facet joint plate 20 from pressing and interfering with the extension channel of the nerve root .
在本实施例中，神经根通道避让缺口23开设在同一侧关节突连接板20上排列的相邻骨结合板30之间，在其他实施方式中，神经根通道避让缺口也可以开设在关节突连接板上的骨结合板与第一关节突结合部或第二关节突结合部之间。需要说明的是，神经根通道避让缺口开设的位置和大小应该经由患者的CT或MRI等医学三维断层扫描数据经计算机逆向建模后量取获得以确保位置尺寸的精确。此外，实施例九的脊柱固定组件的其他结构和工作原理与实施例八基本相同，在此不再赘述。In this embodiment, the nerve root channel avoidance gap 23 is opened between the adjacent osseointegration plates 30 arranged on the facet joint plate 20 on the same side. In other embodiments, the nerve root channel avoidance gap can also be opened in the facet joint Between the osseointegration plate on the connecting plate and the first articular process joint or the second articular process joint. It should be noted that the position and size of the opening of the nerve root channel avoidance gap should be obtained from the patient's CT or MRI and other medical three-dimensional tomographic data after computer reverse modeling to ensure the accuracy of the position and size. In addition, other structures and working principles of the spinal fixation assembly of the ninth embodiment are basically the same as those of the eighth embodiment, and will not be repeated here.
从以上的描述中，可以看出，本实用新型上述的实施例实现了如下技术效果：From the above description, it can be seen that the above-mentioned embodiments of the utility model have achieved the following technical effects:
本实用新型的目的是提供一种可以替代缺失的椎板、棘突、上下关节突而重建脊椎后路稳定力学结构的脊柱固定组件，该脊柱固定组件是依照患者受损脊柱的患处椎体及相邻生理椎体节段的解剖学形态制作的，在骨质缺失时可同时满足占位、支撑、初始固定并实现远期融合固定的一种骨科金属植入物。The purpose of this utility model is to provide a spinal fixation assembly that can replace the missing lamina, spinous process, and upper and lower articular processes to reconstruct the stable mechanical structure of the posterior spine. It is an orthopedic metal implant made according to the anatomical shape of the adjacent physiological vertebral body segments, which can simultaneously meet space occupation, support, initial fixation and long-term fusion and fixation in the event of bone loss.
具体地，上述脊柱固定组件依据患者的CT或MRI等医学三维断层扫描数据定制，完全符合患者个体的解剖学要求；Specifically, the above-mentioned spinal fixation components are customized according to the patient's CT or MRI and other medical three-dimensional tomographic scan data, which fully meets the anatomical requirements of the individual patient;
椎管覆盖板、棘突板、棘突结合部、第一关节突结合部、第二关节突结合部、骨结合板的粗糙表面或多孔层，可形成骨组织和软组织的良好附着及长入，使得脊柱固定组件可以得到良好的远期固定；Spinal canal covering plate, spinous process plate, spinous process junction, first articular process junction, second articular process junction, rough surface or porous layer of osseointegration plate, can form good attachment and ingrowth of bone tissue and soft tissue, So that the spinal fixation components can get good long-term fixation;
脊柱固定组件通过椎管覆盖板、棘突板、棘突结合部、第一关节突结合部、第二关节突结合部、骨结合板、固定棒等一系列结构对患者的上、下相邻健康椎体节段的相应部位进行融合性结合固定，为脊柱椎体缺失节段提供了稳定而长久的后路力学支撑，配合医生对脊柱前路所做的医学处理例如椎间融合、椎体置换等等可以重建脊柱系统的稳定。The spinal fixation component can protect the upper and lower adjacent health of the patient through a series of structures such as the spinal canal covering plate, the spinous process plate, the spinous process joint, the first articular process joint, the second articular process joint, the osseointegration plate, and the fixation rod. The fusion and fixation of the corresponding parts of the vertebral body segments provides a stable and long-term posterior mechanical support for the missing segment of the vertebral body, and cooperates with the medical treatment of the anterior spine by the doctor, such as intervertebral fusion and vertebral body replacement Etc. can rebuild the stability of the spinal system.
以上所述仅为本实用新型的优选实施例而已，并不用于限制本实用新型，对于本领域的技术人员来说，本实用新型可以有各种更改和变化。凡在本实用新型的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本实用新型的保护范围之内。The above descriptions are only preferred embodiments of the utility model, and are not intended to limit the utility model. For those skilled in the art, the utility model can have various modifications and changes. Any modification, equivalent replacement, improvement, etc. made within the spirit and principles of the present utility model shall be included in the protection scope of the present utility model.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201720558080.1UCN207804358U (en) | 2017-05-18 | 2017-05-18 | Backbone fixation kit |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201720558080.1UCN207804358U (en) | 2017-05-18 | 2017-05-18 | Backbone fixation kit |
| Publication Number | Publication Date |
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| CN207804358Utrue CN207804358U (en) | 2018-09-04 |
| Application Number | Title | Priority Date | Filing Date |
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| CN201720558080.1UActiveCN207804358U (en) | 2017-05-18 | 2017-05-18 | Backbone fixation kit |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN107174325A (en)* | 2017-05-18 | 2017-09-19 | 北京爱康宜诚医疗器材有限公司 | Backbone fixation kit |
| CN111297459A (en)* | 2020-03-18 | 2020-06-19 | 北京爱康宜诚医疗器材有限公司 | Laminar components |
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107174325A (en)* | 2017-05-18 | 2017-09-19 | 北京爱康宜诚医疗器材有限公司 | Backbone fixation kit |
| CN107174325B (en)* | 2017-05-18 | 2024-04-12 | 北京爱康宜诚医疗器材有限公司 | Spinal Fixation Components |
| CN111297459A (en)* | 2020-03-18 | 2020-06-19 | 北京爱康宜诚医疗器材有限公司 | Laminar components |
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| Date | Code | Title | Description |
|---|---|---|---|
| GR01 | Patent grant | ||
| GR01 | Patent grant |