CN103300948B - A tape diamond two-way only retreat back teeth ω artificial cervical disc implant prosthesis - Google Patents

A tape diamond two-way only retreat back teeth ω artificial cervical disc implant prosthesis Download PDF

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Publication number
CN103300948B
CN103300948B CN201310217243.6A CN201310217243A CN103300948B CN 103300948 B CN103300948 B CN 103300948B CN 201310217243 A CN201310217243 A CN 201310217243A CN 103300948 B CN103300948 B CN 103300948B
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diamond
body
upper
lower end
bidirectional
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CN201310217243.6A
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Chinese (zh)
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CN103300948A (en
Inventor
汪涛
高亚军
李敏
王晨玥
王阳阳
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南京航空航天大学
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/44Joints for the spine, e.g. vertebrae, spinal discs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof

Abstract

本发明涉及一种带菱形双向止退倒齿的Ω型人工颈椎间盘植入假体,它包括本体,其特征在于本体为上下端板一体化的Ω型非接触的弹性结构,该本体上下端板外表面上分别对称设置菱形双向止退倒齿,本体的下端板长度为10~16mm、上端板长度比下端板短1mm,本体上下端板的间距为2~3.5mm,本体的后端弯曲段厚度为0.6~1.2mm。 The present invention relates to a two-way with the diamond Ω artificial cervical disc implant retaining pawls prosthesis, comprising a body, wherein the body is a resilient structure integrated Ω upper and lower end plates of a non-contact type, the upper and lower ends of the body the outer surface of the diamond plates are disposed symmetrically bidirectional retaining pawls, the lower end of the plate length of the body is 10 ~ 16mm, the upper end plate is shorter than the length of the lower end plate 1mm, the pitch of the body lower end plates 2 ~ 3.5mm, the rear end of the body bending section thickness of 0.6 ~ 1.2mm. 本发明假体植入后空间稳定,实施弹力支撑,无需螺钉固定,从根本上避免了上下端板之间的直接摩擦、磨损,能够满足植入假体长寿命、抗疲劳的性能要求。 Prosthesis of the present invention is stable after implantation space, the supporting force of embodiment, without screws, to avoid direct friction between the upper and lower end plates fundamentally wear implantable prosthesis to meet the long life, fatigue performance requirements. 本发明可实现患者术后颈椎节段前屈活动度及侧屈活动度达到正常颈椎的30%-60%,后伸活动度达到正常颈椎的70%-90%。 The present invention may be implemented cervical flexion and lateral bending activity in patients after segmental activity of 30% -60% of normal cervical, extension activity reached 70% -90% of normal cervical spine.

Description

—种带菱形双向止退倒齿的Ω型人工颈椎间盘植入假体 - Ω artificial cervical disc with a diamond-kind two-way only retreat back tooth implant prosthesis

技术领域 FIELD

[0001] 本发明涉及一种人工颈椎间盘植入假体,特别是涉及一种带菱形双向止退倒齿的Ω型人工颈椎间盘植入假体。 [0001] The present invention relates to an artificial cervical disc implant prostheses, more particularly to a diamond with the two-way retaining pawls Ω artificial cervical disc implant prosthesis.

背景技术 Background technique

[0002] 人体颈椎病是一种常见病和多发病,颈椎病以椎间盘突出为主要致病原因,退变程度轻的,需要进行颈前路的一个或两个节段的减压。 [0002] Human cervical disease is a common and frequently-occurring disease, cervical disc disease as the main cause to light varying degree of degeneration, or a reduced need for two segments of anterior. 传统的颈前路融合手术切除病变的椎间盘,植入自体骨、异体骨或人工骨,部分患者还需要加用钛板内固定,这些手术的最终目的是解除椎间盘对神经的压迫并融合病变的运动节段。 Conventional anterior cervical fusion surgery disc disease, implant autologous bone, allograft bone or artificial bone, some patients need to titanium plus fixation, the ultimate goal of these procedures is to remove the disc and fuse the nerve compression lesion motion segment. 近年来,医学界发现脊椎融合的后遗症,因为颈前路融合术后病变相邻节段代偿性的运动增加,脊椎力量的重新分配,容易造成邻近椎间盘的退化甚至病变。 In recent years, the medical profession found that sequelae of spinal fusion, anterior cervical fusion surgery because the lesion adjacent to compensatory motion segment increased redistribution of the spine forces, likely to cause adjacent disc degeneration and even disease. 一般每融合一节脊椎就会减少七至十度的脊椎活动范围,导致病人生活的不便。 Each spinal fusion is generally an activity will reduce the range of seven to ten of the spine, causing inconvenience to the patient's life. 尽管颈椎前路融合手术对治疗颈椎间盘退变性疾病的近期效果满意,但长期存在的邻近节段的椎间盘退变加速问题未能得到有效的解决。 Although anterior cervical fusion surgery satisfied with recent results in treating cervical degenerative disc disease, but the disc adjacent segment degeneration accelerate long-standing problem has not been effectively addressed.

[0003] 从关节融合术到人工关节置换术是一项外科技术革命,人工颈椎间盘置换术能在进行脊髓减压并提供稳定的同时保持手术节段的生理活动度,更加符合颈椎活动的生物力学特点,可避免邻近节段椎间盘退变加速,为颈椎病的外科治疗提供了一个全新的标准。 At the same time [0003] from the joint fusion surgery to hip replacement surgery is a surgical technique revolution, cervical artificial disc replacement surgery can provide stability during spinal decompression and maintain physiological activity surgery segment, more in line with the biological activity of cervical mechanical characteristics, can avoid adjacent segment disc degeneration accelerated, providing a new standard for the surgical treatment of cervical disease. 人工颈椎间盘假体研发得益于人体其他人工关节几十年的制造经验,是目前最精巧的人工关节,比蚕豆略大。 Artificial cervical disc prosthesis research benefits from decades of manufacturing experience in the human body other artificial joints, is the most sophisticated artificial joints, slightly larger than the beans. 人工椎间盘是一项变革性技术,为更多患者提供了脊椎融合手术的替代方法。 Artificial disc is a transformative technology, provides an alternative to spinal fusion surgery to more patients. 国内外目前常见的适用于人工颈椎间盘置换术的人工颈椎间盘产品比较多,目前临床上主要应用的人工颈椎间盘有Bryan假体Prodisc-C假体Prestige假体PCM假体等。 Currently applies to domestic and foreign common artificial cervical disc replacement of cervical artificial disc products are more artificial cervical disc currently in clinical use are mainly Bryan prosthesis Prodisc-C prosthesis Prestige PCM prosthesis prostheses. 虽然各种假体材料、形态各异,但这些假体普遍存在以下缺点:一是常见的人工颈椎间盘产品结构繁琐、手术相对复杂,易造成异位骨化问题。 Although a variety of prosthetic materials, shapes and sizes, but the prevalence of the following drawback of these prostheses: One common cervical artificial disc product structure complicated, complex surgery is relatively easy to cause ectopic ossification problems. 由于现有的产品不能很好地恢复和维持椎间隙的高度、保持节段稳定性,而引起非典型性骨化。 Due to existing products can not properly restore and maintain disc space height and maintain segmental stability, which leads to atypical ossification. 二是常见的人工颈椎间盘产品抗疲劳和抗磨损性能差,疲劳断裂、疲劳磨损导致假体易产生磨损颗粒,磨损碎粒可引起无菌性骨质吸收,导致假体置换失败,术后易发生并发症;三是公知的弹性人工颈椎间盘假体选用的是钴铬合金、钛合金Ti6A14V或纯钛材料,这几种材料的假体在植入颈椎椎间隙后均不能够很好的恢复正常颈椎节段的运动功能。 Second, a common artificial cervical disc fatigue and wear products poor performance, fatigue fracture, abrasion prosthesis is easy to produce wear particles, wear nibs cause aseptic bone resorption, resulting in failure of the prosthesis replacement, postoperative complications; three known elastic cervical disc prosthesis is selected cobalt-chromium alloy, a titanium alloy or pure titanium material Ti6A14V, these types of prosthetic material not recover well after implantation, the cervical intervertebral space motor function normal cervical segments.

[0004] 中国专利申请200620112142公开了一种“弹片式人工椎间盘”,虽然该方案采用了呈马蹄形的弹片,并在弹片的上下侧分别设置有复数个倒勾等措施来实现与患者正常的椎间盘配合运作的目的,但是还存在以下主要不足:一是从生物物理学角度来看,该弹片的上下侧呈对称结构,既不能满足人体颈椎的生理前凸,也不能很好的填充椎间隙,使得椎间盘的屈曲、伸展运动和压缩减震功能受到限制,所以马蹄形弹片还不是最佳的弹性体;二是弹片的上下侧分别设置的倒勾仅具有单向止退功能,且易造成假体以及椎体表面的应力集中;三是对弯曲弧度和高度缺乏精密性设计手段,使得植入假体不能很好地恢复和维持椎间隙的高度、保持节段的稳定性。 [0004] Chinese Patent Application No. 200620112142 discloses a "pogo artificial disc" Although this embodiment uses a shrapnel horseshoe shape, and is provided with a plurality of undercut upper and lower sides, respectively, and other measures to achieve shrapnel patients with normal disc with the purpose of the operation, but there are the following major disadvantages: First, from the biological point of view of physics, the upper and lower sides of the symmetric leaf spring configuration, neither meet human cervical lordosis, can not well fill the intervertebral space, so that the buckling disc, stretching and compression damping function is limited, it is not the best horseshoe shrapnel elastomer; two undercut upper and lower elastic piece is respectively provided with a unidirectional retaining function only, and could easily lead prosthesis and a stress concentration vertebral surface; Third, the lack of the curvature and high precision design means, such that implantation of the prosthesis is not well maintained and restored disc space height, maintaining the stability of the segment. 四是现有一体化弹片式人工颈椎间盘植入后节段活动度与正常颈椎节段活动度相差较大,不能够很好地恢复正常颈椎节段的运动功能。 Fourth, the integration of existing shrapnel type of artificial cervical disc implant segment activity and normal cervical spine segment quite different activities can not be a good resume normal motor function cervical segments.

[0005] 综上所述,如何克服现有技术的不足已成为当今人工植入假体技术领域中亟待解决的重点难题之一。 [0005] In summary, how to overcome the deficiencies of the prior art has become one of the key challenges of today's technical field of artificial implants in the body to be solved.

发明内容 SUMMARY

[0006] 本发明的目的是为克服现有技术的不足而提供一种带菱形双向止退倒齿的Ω型人工颈椎间盘植入假体,本发明能够满足长寿命抗疲劳性能的要求,极大地保留病变节段的活动度,有利于提高人民群众的健康水平。 [0006] The object of the present invention is to overcome the disadvantages of the prior art and to provide a bi-directional with the diamond of the retaining pawls Ω artificial cervical disc prosthesis is implanted, the present invention is able to meet the long life requirements of fatigue resistance, a very earth retention of active disease segments, will help improve the health of the people.

[0007] 根据本发明提出的一种带菱形双向止退倒齿的Ω型人工颈椎间盘植入假体,它包括本体,其特征在于本体为上下端板一体化的Ω型非接触的弹性结构,该本体上下端板外表面上分别对称设置菱形双向止退倒齿,本体的下端板长度为10~16mm、上端板长度比下端板短1mm,本体上下端板的间距为2~3.5mm。 [0007] The implantable prosthesis made Ω artificial cervical disc with the diamond of the present invention provides a two-way retaining pawls, comprising a body, wherein the body is a resilient structure integrated upper and lower end plates of a non-contact type Ω the upper and lower end plates on the outer surface of the body are symmetrically disposed diamond bidirectional retaining pawls, the lower end of the plate length of the body is 10 ~ 16mm, the upper end plate is shorter than the lower end plate 1mm pitch lower end plates of the body 2 ~ 3.5mm. 本发明进一步的优选方案是:本体上下端板一体化的Ω型非接触的弹性结构的后端弯曲段高度为3.5-6.5mm、后端弯曲段厚度为0.6-1.2 mm ;本体上下端板外表面上分别对称设置的菱形双向止退倒齿均为3个椎骨锚固倒齿。 A further preferred embodiment of the present invention are: the rear end of the elastic structure body Ω type non-contact integrated upper and lower end plates bent section height of 3.5-6.5mm, the rear end of the bent section having a thickness of 0.6-1.2 mm; outer body lower end plates are symmetrically arranged on the surface of a diamond retaining pawls are bidirectional three vertebral anchor pawls.

[0008] 本发明的原理是:从生物物理学角度,本体采用上下端板一体化的Ω型非接触的弹性结构来取代传统的球面、鞍面轴承结构或马蹄形弹片结构,并在本体上下端板外表面设置了与上下椎骨锚固的菱形双向止退倒齿,使其能明显改善假体及椎体的表面应力状态以实现长寿命抗疲劳;通过优化本体关键尺寸及利用其上下端板一体化的Ω型非接触的弹性结构的承载能力和冲击能量吸收能力,使本发明能够很好地恢复和维持椎间隙的高度、保持节段稳定性,极大地保留了椎间盘的屈曲、伸展运动和压缩减震功能。 [0008] The principle of the invention is: Biologically physics, elastic body structure of the upper and lower end plates Ω type non-contact integrated to replace the conventional spherical bearing structure or the saddle face horseshoe elastic piece, and the upper and lower ends of the body the outer surface of the plate is provided with upper and lower vertebral anchors diamond bidirectional retaining pawls, it can significantly improve the surface stress state and the prosthesis of the vertebral body to achieve a long fatigue life; by optimizing the critical dimension of the body and integrally with its upper and lower end plates carrying capacity and impact energy of the resilient structure of the non-contact type Ω absorption capability of the present invention can well restore and maintain the height of the intervertebral space to maintain the stability of the segments, the buckling greatly retained disc, and stretching compression damping function.

[0009] 本发明与现有技术相比其显著优点在于:一是本发明为一体化无移动部件的Ω型非接触的弹性结构的人工颈椎间盘假体形状,假体植入后空间稳定,实施弹力支撑,无需螺钉固定,从根本上避免了上下端板之间的直接摩擦、磨损。 [0009] Compared with the prior art that significant advantages: First, the present invention is a resilient structure integrated cervical artificial non-moving parts of the Ω type non-contact shape of the intervertebral disc prosthesis, the prosthesis after implantation of steric stabilization, embodiment elastically supported, without screws, to avoid direct friction between the upper and lower end plates fundamentally wear. 二是本发明的上下端板外表面上设置了与上下椎骨锚固的六个菱形双向止退倒齿,保证了术后节段的稳定,可防止假体脱出。 Second, the upper and lower end surfaces of the outer plates of the present invention is provided with upper and lower vertebral anchors the six retaining pawls bidirectional diamond, to ensure the stability after the segment, prevented from coming out of the prosthesis. 三是本发明运用有限元分析方法对该人工颈椎间盘进行生物力学有限元模拟设计,保证了该人工颈椎间盘关键尺寸的优化,极大地保留了椎间盘的屈曲、伸展运动和压缩减震功能。 Third, the present invention is the use of finite element analysis of the cervical disc biomechanical finite element simulation design, optimized to ensure that the artificial cervical disc critical dimensions, greatly retained buckling disc, stretching and compression damping function. 四是运用高级结构疲劳分析软件对该新型的人工颈椎间盘进行疲劳分析,能够满足植入假体长寿命、抗疲劳的性能要求。 Fourth, the use of advanced structural fatigue analysis software for the new artificial cervical disc fatigue analysis, to meet the implanted prosthesis long-life, anti-fatigue performance requirements. 五是通过调节人工颈椎间盘假体弯曲段的厚度,可实现患者术后颈椎节段前屈活动度及侧屈活动度达到正常颈椎的30%-60%,后伸活动度达到正常颈椎的70%-90%。 Fifth, by adjusting the thickness of the artificial cervical disc prosthesis curved section, can be achieved in patients after segmental cervical lateral bending and flexion activity activity of 30% -60% of normal cervical, extension activity to normal cervical spine 70 % -90%.

附图说明 BRIEF DESCRIPTION

[0010] 图1为本发明的结构示意图。 [0010] FIG. 1 is a schematic structural diagram of the present invention.

[0011] 图2为本发明的结构剖视图。 [0011] FIG. 2 is a sectional view of the structure of the invention.

[0012] 图3为本发明的结构主视平面示意图。 [0012] FIG 3 a front view of the structure of the present invention, a schematic plan view.

[0013] 图4为本发明的结构俯视平面示意图。 [0013] FIG. 4 is a top plan view of the structure of the invention.

[0014] 图5为本发明的结构侧视平面示意图。 [0014] FIG. 5 a side plan view of the structure of the present invention.

[0015] 图6为前屈载荷下植入人工颈椎间盘的C5-C6单节段颈椎等效应力分布云图。 [0015] FIG. 6 is a cervical disc implant flexion under the load force effects C5-C6 cervical vertebrae single segment contours.

[0016] 图7为前屈载荷下人工颈椎间盘等效应力分布云图。 [0016] FIG. 7 is a cervical disc like effect force distribution cloud the flexion loads.

[0017] 图8为前屈载荷下人工颈椎间盘位移变化图。 [0017] FIG. 8 is a cervical disc displacement flexion under a load of FIG.

[0018] 图9为前屈载荷下C5椎体下表面等效应力分布云图。 [0018] FIG. 9 is a C5 vertebrae under the effect of a force other surface contours flexion loads.

[0019] 图10为后伸载荷下人工颈椎间盘的等效应力分布云图。 [0019] FIG. 10 is equivalent stress cervical artificial disc of the stretch under a load of contours.

[0020] 图11为后伸载荷下人工颈椎间盘的位移变化图。 [0020] FIG. 11 is a rear extension FIG artificial cervical disc displacement under load.

[0021] 图12为后伸载荷下C5椎体下表面等效应力分布云图。 [0021] FIG. 12 is a lower extension force lower loading effects like surface contours C5 vertebrae.

[0022] 图13为侧屈载荷下人工颈椎间盘的等效应力分布云图。 Equivalent stress [0022] FIG. 13 is a lateral bending load cervical disc under the contours.

[0023] 图14为侧屈载荷下人工颈椎间盘的位移变化图。 [0023] FIG. 14 is an artificial cervical disc displacement flexion under load.

[0024] 图15为侧屈载荷下C5椎体下表面等效应力分布云图。 [0024] FIG. 15 is a C5 vertebrae under the effect of a force lateral bending load Surface contours.

具体实施方式 Detailed ways

[0025] 下面结合附图和具体实施方式对本发明作进一步的详细说明。 [0025] The present invention will be described in further detail in conjunction with accompanying drawings and specific embodiments.

[0026] 结合图1,本发明提出的一种带菱形双向止退倒齿的Ω型人工颈椎间盘植入假体,它包括设有上下端板一体化的Ω型非接触的弹性结构的本体(7),该上下端板外表面上分别对称设置菱形双向止退倒齿,菱形双向止退倒齿设置的数量以上下端板各为3个为佳;该上下端板的材质为钛合金,该下端板长度为10~16mm、上端板长度比下端板短1mm,可根据不同患者的病患情况选择下端板长度可选择为10 mm、12 mm、14 mm和16 mm,上端板长度比下端板长度短I臟,对应的人工颈椎间盘宽度分别为12 mm、14 mm、16 mm和18 mm ;该本体(7)上下端板的间距为2~3.5mm,如长度X宽度为10 mmX 12 mm的人工颈椎间盘本体上下端板的间距为2mm,长度X宽度为16 mmX18 mm的人工颈椎间盘本体上下端板的间距为3.5mmο [0026] in conjunction with FIG. 1, Ω proposed artificial cervical disc with the diamond of the present invention provides a two-way retaining pawls implant prosthesis, comprising a body provided with upper and lower end plates of the resilient structure integrated non-contact type [Omega] (7), the outer surfaces of the upper and lower end plates are symmetrically disposed bidirectional retaining pawls diamond, diamond inverted bi retaining the number of teeth disposed above the lower end plate 3 are each preferably; the material of the upper and lower end plates of titanium, the lower end plate length is 10 ~ 16mm, the upper end plate is shorter than the length of the lower end plate 1mm, a length of the lower end plate may be optionally selected to 10 mm in the case of patients according to different patients, 12 mm, 14 mm and 16 mm, a length of the upper end than the lower end plate I dirty short length of the plate, corresponding to the width of the artificial cervical disc are 12 mm, 14 mm, 16 mm and 18 mm; pitch of the body (7) of the upper and lower end plates 2 ~ 3.5mm, such as length X width of 10 mmX 12 artificial cervical disc spacing of the upper and lower end plates of the body of the mm 2mm, length X width 16 mmX18 mm pitch cervical disc body upper and lower end plates of 3.5mmο

[0027] 结合图2和图3,根据人体解剖学有关植入体空间稳定的弯曲弧度及高度的要求,本发明本体(7)上下端板一体化的Ω型非接触的弹性结构的后端弯曲段高度为 [0027] in conjunction with FIGS. 2 and 3, in accordance with the relevant implant human anatomy curvature of space and high stability requirements, the rear end of the elastic structure of the upper and lower end plates Ω integrated non-contact type of the present invention, the body (7) curved section height

3.5-6.5mm、后端弯曲段厚度为0.8-1.2 mm。 3.5-6.5mm, the rear end of the bent section thickness 0.8-1.2 mm. 如长度X宽度为10 mmX 12 mm的人工颈椎间盘本体上下端板一体化的Ω型非接触的弹性结构的后端弯曲段高度为3.5mm、后端弯曲段厚度为0.6mm ;长度X宽度为16_X18 mm的人工颈椎间盘本体上下端板一体化的Ω型非接触的弹性结构的后端弯曲段高度为6.5mm、后端弯曲段厚度为1.2mm。 The length X of 10 mmX 12 mm width artificial cervical disc body rear upper and lower end plates integrated structure elastically bent section Ω type non-contact height of 3.5mm, a thickness of the rear end of the bent section 0.6mm; length X width the rear end of the elastic structure of the non-contact type Ω 16_X18 cervical disc mm body lower end plates of the integrated bent section height 6.5mm, a thickness of the rear end of the bent section of 1.2mm.

[0028] 结合图3、图4和图5,本发明的本体(7)上下端板外表面上分别对称设置的菱形双向止退倒齿均为椎骨锚固倒齿,其中,上端板外表面上设置水平截面形状为菱形的上端板前菱形双向止退倒齿(I)、上端板左菱形双向止退倒齿(2)和上端板右菱形双向止退倒齿(3),相邻两个菱形双向止退倒齿之间的间隙呈O型,各菱形双向止退倒齿的顶端均为与水平面呈2°夹角的微小平台;下端板外表面上设置的下端板前菱形双向止退倒齿(4)、下端板左菱形双向止退倒齿(5)和下端板右菱形双向止退倒齿(6)的形状及分布与上端板设置的菱形双向止退倒齿对称,各菱形双向止退倒齿的顶端均为与水平面呈3°夹角的微小平台。 [0028] in conjunction with FIG. 3, FIG. 4 and FIG. 5, a diamond body according to the present invention (7) on the outer surface of the upper and lower end plates are disposed symmetrically bidirectional retaining pawls are vertebral anchor pawls, wherein the outer surface of the upper plate set the horizontal cross-sectional shape of the front end plate diamond diamond bidirectional retaining pawls (the I), upper left diamond plate bidirectional retaining pawls (2) and a right upper plate diamond bidirectional retaining pawls (3), two adjacent diamond bidirectional retaining gap between the teeth of an inverted O-shape, each of the two-way retaining diamond tips of the teeth are inverted fine platform 2 ° angle to a horizontal plane; the lower end of the front plate diamond plate disposed on the outer surface of the lower retaining pawls bidirectional (4), the lower end plate left diamond bidirectional retaining pawls (5) and a lower end plate and right diamond bidirectional retaining pawls (6) shape and diamond distribution and the upper end plate disposed bidirectional retaining pawls symmetry, each rhombus bidirectional stop back back top teeth are tiny platform 3 ° to the horizontal angle. 菱形双向止退倒齿上端板前菱形双向止退倒齿(I)和下端板前菱形双向止退倒齿(4)的作用是防止假体向后脱出,菱形双向止退倒齿上端板右菱形双向止退倒齿(3)和下端板右菱形双向止退倒齿(6)的作用是防止假体向前脱出,通过设置六个菱形双向止退倒齿保证了人工颈椎间盘假体的空间稳定性。 Diamond bidirectional retaining pawls upper plate before diamond bidirectional retaining pawls (I) and the lower plate before the diamond bidirectional retaining pawls (4) is to prevent the prosthesis coming out backwards, diamond bidirectional retaining pawls upper plate right-diamond bidirectional retaining pawls (3), and a right lower plate diamond bidirectional retaining pawls (6) is to prevent the prosthesis forward prolapse, by providing the two-way six retaining pawls diamond ensures space artificial cervical disc prosthesis stabilizer sex. 上下端板的菱形双向止退倒齿的高度均为 Upper and lower end plates diamond bidirectional locking of the pawls retreat height are

0.8-1.2mm,相邻两个菱形双向止退倒齿之间的间距为0.7-1.1mm ;本体(7)的总体高度为5~8mm。 0.8-1.2mm, diamond bidirectional two adjacent inverted spacing between the retaining teeth are 0.7-1.1mm; overall height of the body (7) is 5 ~ 8mm. 如长度X宽度为10 mmX 12 mm的人工颈椎间盘本体上菱形双向止退倒齿的高度为0.8mm,相邻两个菱形双向止退倒齿的间距为0.8mm,本体的总体高度为5mm ;长度X宽度为16 mmX18 mm的人工颈椎间盘本体上菱形双向止退倒齿的高度为1.2_,相邻两个菱形双向止退倒齿的间距为1.5mm,本体的总体高度为8_。 Artificial cervical disc diamond body such as length X width of 10 mmX 12 mm bidirectional retaining pawls height of 0.8mm, two adjacent retaining pawls diamond bidirectional pitch of 0.8mm, the overall height of the body is 5mm; diamond artificial cervical disc body length X width 16 mmX18 mm bidirectional retaining pawls height 1.2_, bidirectional retaining pawls diamond two adjacent spacing of 1.5mm, the overall height of the body is 8_.

[0029] 本发明的一种典型规格的人工颈椎间盘植入假体的具体实施方式为:本发明在植入前,先对患者颈椎进行椎间盘切除术并对上下椎体进行打磨,然后根据患者颈椎椎体的矢径和横径,选取以下规格的人工颈椎间盘:下端板长度为16mm,宽为14mm,上下端板间距为3 mm ;弹性结构本体(7)的后端弯曲段厚度为0.8 _、后端弯曲段高度为6.0mm ;各菱形双向止退倒齿的高度均为0.8_。 [0029] A typical specification of the present invention, an artificial cervical disc implant prosthesis DETAILED DESCRIPTION: In the present invention, prior to implantation, the cervical spine to the patient discectomy and inferior vertebral bodies for grinding, and then the patient cervical vertebrae and the diameter of the radius vector, select artificial cervical disc with the following specifications: length of the lower end plate of 16mm, width of 14mm, the spacing of upper and lower end plates 3 mm; thickness of the elastic structure of the rear end of the curved section of the body (7) 0.8 _, the rear end of the bent section height 6.0mm; each diamond bidirectional retaining pawls are highly 0.8_.

[0030] 植入时先用工具调整钳略微收紧上端板前菱形双向止退倒齿(I)和下端板前菱形双向止退倒齿(4)的前端,然后轻轻插入到已切除椎间盘的椎体之间,保证植入后人工颈椎间盘后端距椎孔的安全距离为3~4mm,使上端板的各菱形双向止退倒齿与上椎骨接触、下端板的各菱形双向止退倒齿与下椎骨接触。 [0030] When implanting the first adjusting pliers to tighten slightly before the upper end of the diamond plate bidirectional retaining pawls (I) and the lower end of the front plate diamond bidirectional retaining pawls (4) front end, then gently inserted into the resected vertebral disc between the body, after implantation of an artificial cervical disc to ensure safe distance from the rear end of the vertebral foramen 3 ~ 4mm, for each diamond plate the upper end of two-way retaining pawls into contact with the upper vertebra, a lower end of each diamond plate bidirectional retaining pawls contact with the lower vertebra. 这样本发明的人工颈椎间盘假体就能卡掣于上下椎骨之间,依靠自身的弹性取代原有弹性的颈椎间盘。 Such artificial cervical disc prosthesis of the present invention can be hooked in between the upper and lower vertebrae, on their own resilient elasticity replace the original cervical disc.

[0031] 将选取好的人工颈椎间盘以及颈椎C5、C6椎体分别建立几何模型,然后在有限元分析软件中建立植入人工颈椎间盘的C5-C6单节段有限元模型。 [0031] The select good cervical disc and cervical C5, C6 vertebral geometric model are established, then the establishment of C5-C6 single finite element model of the implantation of an artificial cervical disc finite element analysis software. 假体材质选用弹性模量为IlOGPa的TC4钛合金,然后加载前屈载荷并进行有限元模拟分析。 Prosthetic material selection of the elastic modulus IlOGPa TC4 titanium alloy, and then load the flexion loads finite element simulation. 分析所得应力以及位移变化如图6至图9所示,图6为植入人工颈椎间盘的C5-C6单节段颈椎等效应力分布云图,图7为人工颈椎间盘等效应力分布云图,图8为人工颈椎间盘位移变化图,图9为C5椎体下表面等效应力分布云图。 Analysis of the resulting stress and displacement as shown in FIG. 6 to FIG. 9, FIG. 6 equivalent stress contours as a single segment C5-C6 cervical vertebrae cervical artificial disc implant of FIG. 7 and the like equivalent stress contours cervical disc is, FIG. 8 artificial cervical disc displacement, and FIG. 9 is a surface effect force C5 lower vertebral body contours and the like.

[0032] 同时,对植入人工颈椎间盘的C5-C6单节段有限元模型进行了后伸以及侧屈分析,分析所得人工颈椎间盘应力分布以及位移变化如图10至图15所示。 After [0032] Meanwhile, the finite element model of the C5-C6 single-segment implantation of an artificial cervical disc was stretched and lateral bending analysis, the resulting artificial cervical disc displacement and the stress distribution shown in FIG. 10 to FIG. 15. 其中:图10和图13分别为C5-C6单节段后伸以及侧屈时人工颈椎间盘的等效应力分布云图;图11和图14分别为C5-C6单节段后伸以及侧屈时人工颈椎间盘的位移变化图;图12和图15分别为C5-C6单节段后伸以及侧屈时C5椎体下表面等效应力分布云图。 Figure 11 and 14 respectively extending the C5-C6 single segment and lateral bending; FIGS. 10 and 13 respectively extending the C5-C6 single segment and the equivalent stress contours artificial cervical disc Flexor: wherein FIG displacement artificial cervical disc; FIGS. 12 and 15 respectively extending the C5-C6 single segment and the equivalent stress at the surface of the vertebral body and the like when the flexor C5 contours.

[0033] 通过对上述模拟结果进行分析,由图6、图7、图10和图13显示,前屈、后伸、侧屈载荷下假体最大等效应力均在所用钛合金屈服极限之下且倒齿处不会产生过大的应力集中;由图8、图11和图14显示,位移计算得到三种条件下C5-C6单节段运动范围分别为 [0033] By the above-described simulation results were analyzed, FIGS. 7, 10 and 13 shown by FIG. 6, flexion, extension, lateral bending maximum stress at the prosthesis are under load the titanium alloy with yield strength and pawls at no excessive stress concentration; FIG. 11 and FIG. 14 shows, the displacement is calculated from FIG. 8, the range of motion to obtain C5-C6 single segment three conditions are

1.46°、1.91°、0.7°,即植入后端壁厚为0.8mm的TC4钛合金假体后三种条件下节段活动度为正常颈椎的30%。 1.46 °, 1.91 °, 0.7 °, i.e. the wall thickness of the rear end of the implant TC4 titanium prosthesis degree 0.8mm segmental activities three conditions 30% of normal cervical. 这表明该新型的人工颈椎间盘能很好地恢复和维持椎间隙的高度、保持节段活动度;图9、图12和图15显示,椎体表面不会产生过大的应力集中。 This indicates that the novel artificial cervical disc can well restore and maintain intervertebral disc height, retention activities segment; Figures 9, 12 and 15 show, the vertebral body surface will not produce excessive stress concentration.

[0034] 将人工颈椎间盘假体的静力有限元模拟结果导入到高级结构疲劳分析软件中进行疲劳分析,并在Instron疲劳试验机上进行疲劳试验。 [0034] The static finite element simulation of artificial cervical disc prosthesis is introduced into the higher-order structure fatigue analysis software for fatigue analysis, and fatigue tests on an Instron fatigue test machine. 结果表明,该新型人工颈椎间盘假体在经历八千万次循环后未发生疲劳破坏。 The results show that the new artificial cervical disc prosthesis fatigue failure occurred after subjected to eight million cycles.

[0035] 本发明其它几种规格人工颈椎间盘植入假体的具体实施方式为:根据患者颈椎椎体的矢径和横径,选取为长度X宽度分别为10 mmX 12 mm、12 mmX 14 mm、16 mmX 18 mm的三种规格人工颈椎间盘,植入到切除正常人工颈椎间盘的下颈椎相邻椎体节段之中。 DETAILED DESCRIPTION [0035] The present invention several other specifications cervical disc prosthesis for implantation: The cervical vertebrae of the patient and radius vector diameter, length X width selected to be respectively 10 mmX 12 mm, 12 mmX 14 mm , 16 mmX 18 mm in three sizes cervical artificial disc implant to removal of normal cervical artificial disc in the lower cervical vertebrae adjacent segments. 在有限元分析软件中建立有限元模型在前屈、后伸、侧屈载荷下进行生物力学模拟。 In the finite element model of FEM analysis software in flexion, extension, lateral flexion biomechanical simulation under load. 结果表明此三种规格人工颈椎间盘也能较好地恢复和维持椎间隙的高度、保持节段活动度,且椎体表面也不会产生过大的应力集中。 The results show that these three specifications cervical artificial disc can better restore and maintain disc space height, segmental retention activities, and the surface of the vertebral body does not produce excessive stress concentration. 对此三种实施例假体进行疲劳分析和疲劳试验,在经历八千万次循环后也未发生疲劳破坏。 This three embodiments vacation body fatigue analysis and fatigue tests, fatigue failure also occurred after subjected to eight million cycles.

[0036] 本发明经反复试验验证,取得了满意的应用效果。 [0036] The present invention is verified by trial and error, to achieve a satisfactory application.

Claims (5)

1.一种带菱形双向止退倒齿的Ω型人工颈椎间盘植入假体,它包括本体(7),所述本体(7)为上下端板一体化的Ω型非接触的弹性结构,本体(7)上下端板外表面上分别对称设置菱形双向止退倒齿,本体(X)的下端板长度为10〜16mm、上端板长度比下端板短Imm,本体(7)上下端板的间距为2〜3.5mm ;其特征在于所述本体(7)上端板外表面上设置水平截面形状为菱形的上端板前菱形双向止退倒齿(I)、上端板左菱形双向止退倒齿(2)和上端板右菱形双向止退倒齿(3),上端板相邻两个菱形双向止退倒齿之间的间隙呈O型,上端板各菱形双向止退倒齿的顶端均为与水平面呈2°夹角的微小平台;下端板外表面上设置的下端板前菱形双向止退倒齿(4)、下端板左菱形双向止退倒齿(5)和下端板右菱形双向止退倒齿¢)的形状及分布与上端板设置的菱形双向止退倒齿对称,下端板各菱形双向止退 A diamond with the two-way retaining pawls Ω artificial cervical disc implant prosthesis, comprising a body (7), said body (7) is a resilient structure Ω non-contact type integrated upper and lower ends of the plate, upper and lower body (7) on the outer surface of the end plate are symmetrically disposed diamond bidirectional retaining pawls, the lower end plate body length (X) is 10~16mm, the upper end of the plate length shorter than Imm, the lower end plate, the body (7) of the upper and lower end plates spacing 2~3.5mm; characterized in that said body (7) is provided on the outer surface of the horizontal end plate rhombic cross-sectional shape of the front end plate diamond bidirectional retaining pawls (I), a left upper plate diamond bidirectional retaining pawls ( 2) and a right upper plate diamond bidirectional retaining pawls (3), two upper plates adjacent diamond bidirectional retaining a gap between the teeth of an inverted O-shape, each end plate retaining pawls bidirectional diamond tip and are 2 ° angle to the horizontal platform minute; the lower end of the front plate diamond plate disposed on the outer surface of the lower end of bi-retaining pawls (4), a left lower end plate diamond bidirectional retaining pawls (5), and a right lower plate retaining diamond bidirectional inverter tooth ¢) diamond shape and distribution of end plate disposed bidirectional symmetric retaining pawls, each of the lower end plate retaining diamond bidirectional 倒齿的顶端均为与水平面呈3°夹角的微小平台。 Back teeth are the top 3 ° to the horizontal angle tiny platform.
2.根据权利要求1所述的人工颈椎间盘植入假体,其特征在于本体(7)上下端板一体化的Ω型非接触的弹性结构的后端弯曲段高度为3.5〜6.5mm、后端弯曲段厚度为0.6〜1.2mm。 The artificial cervical disc implant according to claim 1, wherein the prosthesis, characterized in that the rear end of the bent section of the resilient structure body (7) upper and lower end plates of non-contact type integrated Ω height 3.5~6.5mm, after end of the curved section thickness 0.6~1.2mm.
3.根据权利要求1所述的人工颈椎间盘植入假体,其特征在于本体(J)上下端板外表面上分别对称设置的菱形双向止退倒齿均为3个椎骨锚固倒齿。 3. The artificial cervical disc implant according to claim 1, prosthesis, wherein the outer surface of the diamond body (J) upper and lower end plates are disposed symmetrically retaining pawls are bidirectional three vertebral anchor pawls.
4.根据权利要求1所述的人工颈椎间盘植入假体,其特征在于菱形双向止退倒齿高度为0.8〜1.2mm,相邻两个菱形双向止退倒齿之间的间距为0.7〜1.1mm。 The artificial cervical disc implant according to claim 1, wherein the prosthesis, characterized in that the retaining pawls diamond bidirectional height 0.8~1.2mm, diamond bidirectional two adjacent inverted spacing between the retaining teeth are 0.7~ 1.1mm.
5.根据权利要求1所述的人工颈椎间盘植入假体,其特征在于本体(7)的总体高度为5 〜8mm ο The artificial cervical disc implant according to claim 1, wherein the prosthesis, characterized in that the overall height of the body (7) is from 5 ~8mm ο
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CN201676036U (en) * 2009-10-27 2010-12-22 上海通悦医疗器械有限公司 Cervical vertebra space dynamic stabilizing implanting apparatus for medical use in orthopedics department
CN102892387A (en) * 2010-03-16 2013-01-23 品尼高脊柱集团有限责任公司 Intervertebral implants and graft delivery systems and methods

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