CN106236333B - Artificial vertebral body fixed by anterior pedicle screw and positioning and installing tool - Google Patents
Artificial vertebral body fixed by anterior pedicle screw and positioning and installing tool Download PDFInfo
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- A—HUMAN NECESSITIES
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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Abstract
Description
技术领域technical field
本发明属于医疗器械领域,尤其是一种以前路椎弓根钉固定之人工椎体及定位安装工具。The invention belongs to the field of medical instruments, in particular to an artificial vertebral body and a positioning and installation tool for anterior pedicle screw fixation.
背景技术Background technique
颈椎肿瘤、结核、创伤等病变切除后需行稳定型重建手术,目前通常采用自体骨或异体骨或人工骨、或者钛网或人工椎体支撑于缺损处,再用锁定螺钉将钢板固定于保留下的椎体上。但由于椎体均是松质骨,且前后径较短,仅能使用15mm左右的螺钉。因此固定强度较弱,需用颈部支具进行长达数个月的固定。尤其在螺钉固着的椎体本身也有病变或重建节段较长的病例,其固定作用更弱,固定失效所致脊柱移位、骨不愈合、钢板螺钉和植入物松动错位断裂等并发症时有发生。比如颈椎结核,通常发生于椎间盘及上、下椎体边缘,上位椎体的上部和下位椎体的下部骨质相对完整,可供螺钉固定,但在MRI上该处的骨质常被浸润,椎体的松质骨将变得更加松脆,仅仅依靠2枚椎体钉难以获得稳定的固定,要增强固定力就要作病变椎体的切全切除手术,那么必然要将上下端的椎间盘一并切除以提供植骨床,供植入的支撑物融合于其上,如此就增加了固定节段,减少了颈椎的活动范围,也更容易发生相邻节段的退变。再如,长节段颈椎肿瘤需将所有病变椎体及其上下椎间盘全部切除,用钛网或人工椎体支撑后,钢板两端只能各打两枚椎体钉,而所切除的椎体处无法用螺钉加固,至使钢板的跨度过长,固定强度自然减弱。长节度颈椎创伤行前路减钛网内固定后同样存在上述问题。Stable reconstruction surgery is required after cervical spine tumor, tuberculosis, trauma and other lesions are removed. At present, autologous bone or allogeneic bone or artificial bone, or titanium mesh or artificial vertebral body is usually used to support the defect, and then the plate is fixed with locking screw on the lower vertebral body. However, because the vertebral bodies are all cancellous bone and the anterior and posterior diameters are short, only about 15mm screws can be used. Therefore, the fixation strength is weak, and it needs to be fixed with a neck brace for several months. Especially in cases where the screw-fixed vertebral body itself has lesions or has a long reconstructed segment, the fixation effect is weaker, and complications such as spinal displacement, bone nonunion, loosening of plate screws and implants due to fixation failure, and fracture of implants are caused. has happened. For example, cervical vertebral tuberculosis usually occurs in the intervertebral disc and the edges of the upper and lower vertebral bodies. The upper part of the upper vertebral body and the lower part of the lower vertebral body are relatively intact and can be fixed by screws. However, on MRI, the bone is often infiltrated. The cancellous bone of the vertebral body will become more brittle, and it is difficult to obtain stable fixation with only two vertebral body screws. To enhance the fixation force, a total resection of the diseased vertebral body is necessary, so the upper and lower intervertebral discs must be separated. And resection to provide a bone graft bed on which the implanted support is fused, thus increasing the fixed segment, reducing the range of motion of the cervical spine, and making it easier for the degeneration of adjacent segments to occur. For another example, in the case of a long-segment cervical spine tumor, all diseased vertebral bodies and their upper and lower intervertebral discs should be removed. After using titanium mesh or artificial vertebral body support, only two vertebral body screws can be inserted at each end of the steel plate. It cannot be reinforced with screws, so that the span of the steel plate is too long, and the fixing strength is naturally weakened. The above-mentioned problems also exist in the long-segmented cervical vertebrae after anterior fixation with reduced titanium mesh.
为解决此问题,近年出现了前路颈椎弓根螺钉固定技术的研究,即自椎体前方向脊椎最坚强的椎弓根穿入超出椎体钉一倍多长度的螺钉进行固定。基础研究显示,其固定强度成倍提升。但由于椎体表面缺乏可供定位的解剖标志,置钉过程中极易误伤椎动脉、脊髓或神经根等重要结构;加之螺钉与钢板的交角较大,锁定螺钉尾端常会高凸于钢板之上,顶在食管后壁,阻碍食管呑咽产生的蠕动,引起食管后壁充血水肿,进而导致食道瘘。上述并发症均可致生命危险或高位截瘫等极为严重的后果的。此外,由于颈椎弓根轴线与颈椎矢状线交角过大,同一椎体的两枚椎弓根钉尾端将会相交。因此目前国内外仅有极少数专家报道了颈前路椎弓钉的临床病例,且均为单枚螺钉固定。胸腰椎病变同样存在着上述问题。In order to solve this problem, in recent years, there has been research on anterior cervical pedicle screw fixation technology, that is, from the front of the vertebral body, the strongest pedicle of the spine is inserted into the screw with more than double the length of the vertebral body screw for fixation. Basic research has shown that its fixation strength is multiplied. However, due to the lack of anatomical landmarks for positioning on the surface of the vertebral body, important structures such as the vertebral artery, spinal cord or nerve root are easily injured during screw placement. In addition, the angle between the screw and the steel plate is large, and the tail end of the locking screw often protrudes above the steel plate. On the top of the esophagus, the top of the back wall of the esophagus hinders the peristalsis generated by esophagus pharyngeal, causing congestion and edema of the back wall of the esophagus, which in turn leads to esophageal fistula. The above complications can lead to life-threatening or high paraplegia and other extremely serious consequences. In addition, because the angle between the axis of the cervical pedicle and the sagittal line of the cervical spine is too large, the tail ends of the two pedicle screws of the same vertebral body will intersect. Therefore, only a few experts at home and abroad have reported clinical cases of anterior cervical pedicle screw fixation, and they are all fixed with a single screw. Thoracic and lumbar spine lesions also have the above problems.
发明内容SUMMARY OF THE INVENTION
为解决脊柱前路固定强度较弱这一难题,本发明设计了一种以前路椎弓根钉固定之人工椎体,及辅助定位安装的手术工具。In order to solve the problem of weak anterior fixation strength of the spine, the present invention designs an artificial vertebral body fixed with anterior pedicle screws, and a surgical tool for auxiliary positioning and installation.
为实现本发明的目的,本发明所采用的技术方案为:For realizing the purpose of the present invention, the technical scheme adopted in the present invention is:
利用医学影像数据和3D打印技术建立病变脊柱的数学模型,根据病情分析,在模型上作出病变切除范围的规划,并虚拟切除病变,同时虚拟调整恢复脊柱的位置,使脊柱高度、曲度等恢复至术中可以矫正到的最佳状态。再根据此状态下骨缺损的情况,设计出填补缺损、支撑脊柱的人工椎体,或加上及用以固定脊柱的钢板。本发明可将人工椎体与钢板融为一体,钢板即为人工椎体的前壁。优选的,所述钢板可两端略长于人工椎体,也可仅上端长于人工椎体。在钢板超出人工椎体的两端各有若干个螺钉孔。优选的,所述螺钉孔可以是与椎弓根同轴的,也可以是非精准定向指向椎体的,或是两者的组合。优选的,人工椎体部分也设计出与所切除的所有椎体之椎弓根同轴的固定钉孔,且所有椎体均可设计出两个椎弓根钉固定孔,亦即所有椎体均可进行双侧前路椎弓根钉固定。因此,其固定强度可达最大化。Use medical image data and 3D printing technology to establish a mathematical model of the diseased spine, according to the disease analysis, make the planning of the lesion resection range on the model, and virtually remove the lesion, and at the same time adjust the position of the restored spine virtually, so that the height and curvature of the spine can be restored. to the best condition that can be corrected intraoperatively. According to the bone defect in this state, an artificial vertebral body to fill the defect and support the spine, or a steel plate to fix the spine is designed. The invention can integrate the artificial vertebral body with the steel plate, and the steel plate is the front wall of the artificial vertebral body. Preferably, both ends of the steel plate may be slightly longer than the artificial vertebral body, or only the upper end may be longer than the artificial vertebral body. There are several screw holes on both ends of the steel plate beyond the artificial vertebral body. Preferably, the screw hole may be coaxial with the pedicle, or may be directed to the vertebral body in an imprecise orientation, or a combination of the two. Preferably, the artificial vertebral body part is also designed with fixed screw holes coaxial with the pedicles of all vertebral bodies to be removed, and all vertebral bodies can be designed with two pedicle screw fixing holes, that is, all vertebral bodies can be designed with two pedicle screw fixing holes. Bilateral anterior pedicle screw fixation can be performed. Therefore, its fixing strength can be maximized.
为保证病变椎体切除、原有体表标志缺失,所述人工椎体植入骨缺损处以后仍能经椎弓根钉固定孔精准植入椎弓根螺钉,本发明还包括利用原始骨面制作的椎弓根钻孔导板与截骨导板。优选的,所述钻孔导板以手术区域内在建模时表面尚致密平滑的骨面为蒙版,在外表面每个椎弓根长轴延长线上制作突起的钻孔导向管;同一椎体上两个椎弓根导向管的基底可以相交,两个导向管内部管腔也可相交。所述截骨导板的蒙版亦按上述要求制作,并在计划截骨的平面制作出镂空的截骨引导窗口。通过所述钻孔导板可以预先进行前路双侧椎弓根钻孔,开出椎弓根钉道;换用截骨导板则能按计划实行精准范围的病变清除,植入人工椎体后,经其上打印好了的椎弓根钉固定孔探查已钻出的椎弓根钉道,可以验证人工椎体安置是否准确,并根据已成型的椎弓根钉道对人工椎体的摆放进行微调,实现精准、安全、快捷的前路椎弓根螺钉固定术。In order to ensure the excision of the diseased vertebral body and the loss of the original body surface markers, the artificial vertebral body can still be accurately implanted through the pedicle screw fixation hole after the artificial vertebral body is implanted in the bone defect. The present invention also includes using the original bone surface. The fabricated pedicle drilling guide and osteotomy guide. Preferably, the drilling guide plate uses the bone surface that is still dense and smooth during modeling in the operating area as a mask, and makes a protruding drilling guide tube on the long axis extension of each pedicle on the outer surface; on the same vertebral body The bases of the two pedicle guide tubes can intersect, and the inner lumens of the two guide tubes can also intersect. The mask of the osteotomy guide is also made according to the above requirements, and a hollow osteotomy guide window is made on the plane where the osteotomy is planned. Through the drilling guide, the anterior bilateral pedicle drilling can be carried out in advance, and the pedicle screw canal can be opened; the osteotomy guide can be used to remove the lesions in a precise range as planned. After implanting the artificial vertebral body, Exploring the drilled pedicle screw channel through the pedicle screw fixing hole printed on it can verify whether the artificial vertebral body is placed accurately, and place the artificial vertebral body according to the formed pedicle screw channel. Fine-tuning to achieve accurate, safe and fast anterior pedicle screw fixation.
本发明所设计出的人工椎体与所有导板是基于3D打印技术采用金属或非金属3D打印机制造的,能够实现设计的制造要求。尤其是植入物可以打印成多孔隙边缘加密的仿生的骨小梁结构,有效防止其沉陷并利于其与宿主骨的融合。The artificial vertebral body and all guide plates designed by the present invention are manufactured by metal or non-metal 3D printers based on 3D printing technology, and can meet the manufacturing requirements of the design. In particular, the implant can be printed into a biomimetic bone trabecular structure with dense porous edges, which can effectively prevent its subsidence and facilitate its fusion with the host bone.
本发明的安装也可在导航与机器人的辅助下进行。The installation of the present invention can also be carried out with the aid of navigation and robotics.
本发明的有益效果是,可以精确定制出个体化的、附带可实现自我稳定机制最大化的人工椎体,并能够安全、快捷、精准地实现脊柱前路病变切除稳定性重建手术固定强度的最大化,同时实现植入物与人体组织的友善融合与长期稳定。The beneficial effect of the present invention is that the individualized artificial vertebral body with the self-stabilizing mechanism maximization can be precisely customized, and the maximum fixation strength of the anterior spinal lesion resection, stability reconstruction operation can be realized safely, quickly and accurately. At the same time, it can achieve friendly fusion and long-term stability of implants and human tissue.
附图说明Description of drawings
图1为本发明加装螺钉的后侧向示意图;Fig. 1 is the rear side schematic diagram of adding screw according to the present invention;
图2为本发明的前侧向示意图;Fig. 2 is the front side schematic diagram of the present invention;
图3为本发明定位钻孔导板示意图;3 is a schematic diagram of a positioning drilling guide plate of the present invention;
图4为本发明截骨导板示意图;Fig. 4 is the schematic diagram of the osteotomy guide plate of the present invention;
图中:In the picture:
1.椎体;2.钢板;3.螺钉孔;4.椎弓根钉固定孔;5.椎弓根钉;6.椎体螺钉;7.钻孔导板蒙板;8.导向管;9.截骨导板蒙板。1. Vertebral body; 2. Plate; 3. Screw hole; 4. Pedicle screw fixation hole; 5. Pedicle screw; 6. Vertebral screw; 7. Drill guide plate; 8. Guide tube; 9 . Osteotomy guide mask.
具体实施方式Detailed ways
下面结合附图与实施例对本发明作进一步阐述。The present invention will be further described below with reference to the accompanying drawings and embodiments.
本发明所述人工椎体可以是由椎体1与钢板2合成的带翼柱状体,也可以是单纯的柱状体。椎体1呈中空桶状,用以填充自体或异体、异种骨或人工骨。椎体1外形可根据切除了的病变椎体及其相邻椎体形状灵活设定。如,其截面可以是圆形、椭圆形、矩形、梯形等。The artificial vertebral body of the present invention may be a winged columnar body composed of a vertebral body 1 and a
优选的,所述带翼柱状体样式的人工椎体由钢板2紧贴于椎体1前壁,并与之融为一体组成,以加厚前壁。钢板2长度大于椎体1长度。可以是两端均超出椎体1边缘的双翼柱状;也可以是上端超出椎体1,下端与椎体1平齐的单翼柱状。钢板2两端超出椎体1的部分各设置若干个螺钉孔3,用以横穿螺钉,将钢板2固定于椎体1所支撑的脊椎椎体或椎弓根上。Preferably, the artificial vertebral body in the form of a winged columnar body is composed of a
优选的,所述钢板2两端的螺钉孔3可分为椎弓根钉孔与椎体钉孔,椎弓根钉孔与所对应的椎弓根同轴,椎弓根螺钉5经此孔穿过椎弓根纵轴并固定于其上;椎体钉孔的轴线指向椎体后方,椎体螺钉6经此孔拧入椎体中。Preferably, the screw holes 3 at both ends of the
优选的,所述椎体1及钢板2长度均根据需切除重建的脊椎数量及是否全椎体切除等病情需要酌定,但人工椎体对应于每个切除了椎体的脊椎两侧椎弓根轴线上均设有椎弓根钉固定孔4,贯穿椎体1前后壁;每个固定孔4均呈单级阶梯管状,用以容纳椎弓根螺钉5钉头并防止椎弓根螺钉下沉。为避免两侧椎弓根螺钉5碰撞,固定孔4尾端的较粗孔道应加深至能使椎弓根螺钉5沉陷于椎体1加压厚了的前壁内。Preferably, the lengths of the vertebral body 1 and the
本发明的椎弓根螺钉与椎体螺钉均由带螺纹的钉体及较钉体直径更大以产生加压机制并预防螺钉沉陷的钉头部分组成,钉头短小,钉头形状仅允许其在拧入螺钉孔后与钢板2平齐,或略高于钢板2表面且须是平滑的微凸状。螺钉孔3与螺钉的结合可以是能旋转与偏摆的普通螺钉结构,也可以是锁定结构。The pedicle screw and the vertebral body screw of the present invention are both composed of a screw body with threads and a screw head part with a larger diameter than the screw body to generate a compression mechanism and prevent the screw from sinking. The screw head is short and the shape of the screw head only allows its After screwing into the screw holes, it should be flush with the
本发明还包括利用原始骨面制作的椎弓根钻孔导板与截骨导板。优选的,所述钻孔导板以手术区域内在建模时表面尚致密平滑的骨面为钻孔导板蒙版7,钻孔导板蒙版7的内表面与所贴合的骨性结构外表面吻合,钻孔导板蒙版7按压卡在骨面上后不能发生任何方向的微动。在钻孔导板蒙版7的外表面沿每个椎弓根长轴延长线制作与钻孔导板蒙版7藕合的钻孔导向管8,所述导向管8可约束钻头只能沿其纵轴前进,即只能沿椎弓根纵轴前进,以此精准地开出椎弓根钉道;同一椎体上两个椎弓根钻孔导向管8的基底可以相交,管壁可以互相融合,其内部管腔也可相交。The invention also includes a pedicle drilling guide plate and an osteotomy guide plate made by using the original bone surface. Preferably, the drill guide mask 7 is the drill guide mask 7 whose surface is still dense and smooth during modeling in the operating area, and the inner surface of the drill guide mask 7 matches the outer surface of the attached bony structure. , the drilling guide mask 7 cannot move in any direction after being pressed and stuck on the bone surface.
所述截骨导板的截骨导板蒙版9亦按上述要求制作,并在计划截骨的平面制作出镂空的截骨引导窗口,窗口边缘即为截骨引导面10。The
通过所述钻孔导板可以预先进行前路双侧椎弓根钻孔,开出椎弓根钉道;换用截骨导板则能按计划实行范围精准的病变清除。在清除病变后的缺损中植入人工椎体后,经其上打印好了的椎弓根钉固定孔5探查已钻出的椎弓根钉道,可以验证人工椎体安置是否准确,并根据已成型的椎弓根钉道对人工椎体的摆放进行微调,从而实现精准、安全、快捷的前路椎弓根螺钉固定。Through the drilling guide, the anterior bilateral pedicle drilling can be performed in advance, and the pedicle screw canal can be opened; the osteotomy guide can be used to perform accurate lesion removal according to the plan. After the artificial vertebral body is implanted in the defect after the lesion is removed, the drilled pedicle screw canal can be explored through the pedicle
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