技术领域technical field
本发明涉及一种新型人工颈椎间盘假体，用于替换脊柱相邻椎骨间退变的椎间盘，属医用植入性骨科医疗器械领域。The invention relates to a novel artificial cervical intervertebral disc prosthesis, which is used for replacing degenerated intervertebral discs between adjacent vertebrae of the spine, and belongs to the field of medical implantable orthopedic medical devices.
背景技术Background technique
颈椎疾病是一种常见病和多发病，随着现代生活节奏的加快，生活方式的改变(如以车代步、久坐不动)，全世界颈椎间盘疾病的发病率逐年上升。颈椎间盘疾病的治疗包括保守和手术等治疗方式，对于严重和发展迅速的椎间盘疾病来说，手术治疗是目前最佳的治疗方式。现有的治疗方式有同种异体间盘移植，髓核置换，融合减压植骨融合术，人工颈椎间盘置换四种。前三种较为传统的手术治疗或存在产品来源困难、或存在排异反应、或存在颈椎相邻节段运动丧失等缺陷，全人工颈椎间盘置换术正是鉴于传统治疗方法的缺陷应运而生，其设计理念是在前路椎间盘切除后通过在椎间隙植入一个可以活动的装置，代替原来的椎间盘并行使其功能，实现保留颈椎运动的运动功能，同时提供颈椎所需要的稳定性，防止和延缓相邻阶段退变的发生和发展的目的。Cervical spondylosis is a common and frequently-occurring disease. With the acceleration of the pace of modern life and changes in lifestyle (such as walking by car and sedentary), the incidence of cervical disc disease worldwide is increasing year by year. The treatment of cervical intervertebral disc disease includes conservative treatment and surgical treatment. For severe and rapidly developing intervertebral disc disease, surgical treatment is currently the best treatment. The existing treatment methods include allograft intervertebral disc transplantation, nucleus pulposus replacement, fusion decompression and bone graft fusion, and artificial cervical disc replacement. The first three kinds of more traditional surgical treatments may have defects such as difficulty in product source, rejection, or loss of motion of adjacent segments of the cervical spine. Total artificial cervical disc replacement came into being in view of the defects of traditional treatment methods. Its design concept is to replace the original intervertebral disc and perform its function by implanting a movable device in the intervertebral space after anterior discectomy, so as to realize the movement function of retaining the cervical spine, and at the same time provide the stability required by the cervical spine to prevent and The purpose of delaying the occurrence and development of adjacent stage degeneration.
目前国际上已有十余种颈椎间盘假体上市或经FDA批准进入临床阶段，而在国内，尚无自主研发的颈椎间盘假体产品上市。目前应用的颈椎间盘假体可以分为两类，一类是单一运动中心的刚性间盘，此类假体虽能够基本保持颈椎的活动度，但不具有弹性，在受到震荡时不能很好的保护颈椎，另外金属与金属间的磨屑，会对周围的组织造成影响。另一类是多运动中心的、以高分子材料为髓核的间盘，如专利CN102648879A、CN101961270A、CN103417313A等公开的椎间盘假体，采用超高分子量聚乙烯材料或聚醚醚酮作为髓核材料，但其结构仍属硬支撑球窝结构，这种硬支撑力学特性与人体颈椎间盘的完美结构及力学性征相差较大，并且仍存在一定的磨屑隐患。实际上，人体颈椎间盘是位于颈椎两椎体之间，由软骨板、纤维环、髓核组成的一个密封体，其髓核材料是一种富于弹性的胶状物质，在受到外力时，髓核通过改变形态将应力传送到纤维环的各部分，再经过纤维环的张应力将其分散，从而起到吸收和传递外力振荡的作用。人体颈椎间盘本质上是一种具有弹性的结构，显然传统的硬支撑的滑移摩擦结构不能很好的模拟人体颈椎间盘的结构及活动特性。近几年，关于以弹性体材料为髓核的椎间盘假体的研究开始引起人们的关注，这类弹性体类的人工椎间盘，可以吸收在竖直方面上的冲击，并且有承受负载的能力，具有更好的仿生效果。此类人工椎间盘的难点在于如何实现弹性体髓核材料与刚性终板的固定连接，传统的通过机械嵌合等连接方式，虽然实现了一定的连接，但弹性体髓核材料与金属刚性终板会存在界面问题，植入体内长时间使用过程中仍存在因反复摩擦使得材料磨损、生热、脱落等问题。专利CN101836907A和专利292927749U公开的两种整体式的人工椎间盘，通过一体式连接，在一定程度上减小了弹性体与刚性终板材料的摩擦界面，但其整体结构主要是由刚性终板、弹性髓核及其它相关部件后续组装形成，弹性体核心与刚性终板仍存在界面。另外由于刚性终板与弹性髓核材料对载荷的形变响应有较大差异，在长期使用过程中，也会在刚性终板与弹性体髓核材料间产生新的界面。在植入人体长时间运转过程中，刚性终板与弹性体髓核之间仍会有一些交界面问题，各部件的装配的牢固性和稳定性也会有一定影响。另外，目前大部分人工颈椎间盘为防止因间盘活动度过大对间盘周围关节组织造成伤害，在设计上采用一些限位结构，但这些结构多为刚性结构，当人工颈椎间盘达到一定的活动度后，在刚性限位结构的作用下，活动性会突然停止，没有一个过渡限位的过程，不能很好地模拟人体椎间盘的机能。基于目前颈椎疾病的趋势及相关人工颈椎间盘产品的缺陷，对于开发性能更加仿生的人工颈椎间盘具有持续的需求。At present, there are more than ten kinds of cervical intervertebral disc prosthesis on the market in the world or have entered the clinical stage with FDA approval, but in China, there is no self-developed cervical intervertebral disc prosthesis on the market. The cervical intervertebral disc prosthesis currently used can be divided into two categories, one is a rigid intervertebral disc with a single center of motion. Although this type of prosthesis can basically maintain the range of motion of the cervical spine, it is not elastic and cannot perform well when subjected to shocks. Protect the cervical spine, and the grinding debris between metal and metal will affect the surrounding tissues. The other is a multi-movement center intervertebral disc with a polymer material as the nucleus pulposus, such as the intervertebral disc prosthesis disclosed in patents CN102648879A, CN101961270A, CN103417313A, etc., using ultra-high molecular weight polyethylene material or polyether ether ketone as the nucleus pulposus material , but its structure is still a hard-supported ball-and-socket structure. The mechanical properties of this hard-supported disc are quite different from the perfect structure and mechanical properties of the human cervical intervertebral disc, and there are still certain hidden dangers of wear debris. In fact, the human cervical intervertebral disc is located between the two vertebral bodies of the cervical vertebrae. It is a sealed body composed of cartilage plate, fibrous ring, and nucleus pulposus. The nucleus pulposus transmits stress to various parts of the fibrous annulus by changing its shape, and then disperses it through the tensile stress of the fibrous annulus, thereby absorbing and transmitting external force oscillations. The human cervical intervertebral disc is essentially an elastic structure. Obviously, the traditional hard-supported sliding friction structure cannot well simulate the structure and activity characteristics of the human cervical intervertebral disc. In recent years, the research on the intervertebral disc prosthesis with elastomeric material as the nucleus pulposus has begun to attract people's attention. This kind of elastomeric artificial intervertebral disc can absorb the impact in the vertical direction and has the ability to bear the load. It has a better bionic effect. The difficulty of this type of artificial intervertebral disc lies in how to realize the fixed connection between the elastomeric nucleus pulposus material and the rigid endplate. Although the traditional connection methods such as mechanical fitting have achieved a certain connection, the elastomeric nucleus pulposus material and the metal rigid endplate There will be interface problems, and there will still be problems such as material wear, heat generation, and shedding due to repeated friction during the long-term use of implants in the body. Patent CN101836907A and patent 292927749U disclose two integral artificial intervertebral discs, which reduce the friction interface between the elastic body and the rigid endplate material to a certain extent through integral connection, but the overall structure is mainly composed of rigid endplate, elastic The nucleus pulposus and other related components are subsequently assembled, and the interface between the elastomeric core and the rigid endplate still exists. In addition, due to the large difference in the deformation response of the rigid endplate and the elastic nucleus pulposus material to the load, a new interface will also be generated between the rigid endplate and the elastic nucleus pulposus material during long-term use. During the long-term operation of implanting into the human body, there will still be some interface problems between the rigid endplate and the elastomeric nucleus pulposus, and the firmness and stability of the assembly of each component will also be affected to a certain extent. In addition, most of the current artificial cervical intervertebral discs are designed to prevent damage to the joint tissue around the intervertebral disc due to excessive activity of the intervertebral disc. However, these structures are mostly rigid structures. When the artificial cervical intervertebral disc reaches a certain After the degree of mobility, under the action of the rigid limiting structure, the mobility will suddenly stop, there is no transitional limiting process, and the function of the human intervertebral disc cannot be well simulated. Based on the current trend of cervical diseases and the defects of related artificial cervical intervertebral disc products, there is a continuous demand for the development of artificial cervical intervertebral discs with more bionic performance.
发明内容Contents of the invention
针对现有人工颈椎间盘的上述问题，本发明提供了一种更加仿生的一体式人工颈椎间盘假体。所述的人工颈椎间盘假体由上、下刚性终板，连接上下刚性终板的弹性体髓核材料及外层保护膜材料组成。所述的人工颈椎间盘假体具有以下显著特点：(1)弹性体髓核材料通过原位成型的方法与上、下刚性终板一体化原位成型，并通过上下刚性终板的空腔、凹槽、凸台、贯通孔等结构，形成刚性终板与弹性体髓核材料的相互嵌合包覆的一体化结构，不存在弹性体髓核与刚性终板的关节面，克服了目前人工椎间盘的刚性终板与聚合物材料的摩擦界面问题，有效降低或消除刚性终板与髓核材料因界面摩擦造成的材料破坏及磨屑隐患；(2)上下刚性终板之间设计有弹性体限位结构，在人工颈椎间盘达到一定活动度后对其实现弹性限位，有效避免因人工颈椎间盘活动度过大引起的邻近关节的损伤；(3)整个人工颈椎间盘弹性的非硬支撑滑动结构，通过弹性体髓核材料的弹性变形有效实现人工颈椎间盘在旋转、屈伸、平移三维六个自由度空间的活动；(4)上、下刚性终板与椎骨接触的表面采用与椎骨表面近似的弧度设计，植入后与椎骨具有较高的接触面，手术中可尽可能多的保留人体椎骨的骨性终板，简化手术的操作，并保留可翻修性；(5)刚性终板表面设计有稳定齿及钛涂层或羟基磷灰石涂层结构，植入后有效实现人工颈椎间盘的即刻稳定性及后期的骨整合；(6)髓核材料外侧设计有一层弹性保护膜，能够有效防止人体软组织地长入。Aiming at the above-mentioned problems of the existing artificial cervical intervertebral disc, the present invention provides a more bionic one-piece artificial cervical intervertebral disc prosthesis. The artificial cervical intervertebral disc prosthesis is composed of upper and lower rigid endplates, an elastomeric nucleus pulposus material connecting the upper and lower rigid endplates, and an outer protective film material. The artificial cervical intervertebral disc prosthesis has the following remarkable features: (1) The elastic body nucleus pulposus material is integrated with the upper and lower rigid endplates by in-situ forming, and is formed through the cavities of the upper and lower rigid endplates, Structures such as grooves, bosses, and through-holes form an integrated structure in which the rigid endplate and the elastomeric nucleus pulposus material are fitted and covered with each other. There is no articular surface between the elastomeric nucleus pulposus and the rigid endplate, which overcomes the current artificial The problem of the friction interface between the rigid endplate and the polymer material of the intervertebral disc can effectively reduce or eliminate the material damage and wear debris caused by the friction between the rigid endplate and the nucleus pulposus material; (2) There is an elastic body between the upper and lower rigid endplates The limit structure, after the artificial cervical intervertebral disc reaches a certain range of motion, it can achieve elastic limit, effectively avoiding the damage of adjacent joints caused by the excessive activity of the artificial cervical intervertebral disc; (3) The entire artificial cervical intervertebral disc slides elastically without hard support structure, through the elastic deformation of the elastomeric nucleus pulposus material, the activities of the artificial cervical intervertebral disc in the three-dimensional six-degree-of-freedom space of rotation, flexion and extension, and translation are effectively realized; (4) the surface of the upper and lower rigid endplates in contact with the vertebra is similar to the surface of the vertebra The radian design has a higher contact surface with the vertebrae after implantation. During the operation, as many bony endplates of the human vertebrae as possible can be preserved, which simplifies the operation of the operation and retains the reversibility; (5) The surface of the rigid endplate It is designed with stable teeth and titanium coating or hydroxyapatite coating structure, which can effectively realize the immediate stability and later osseointegration of the artificial cervical intervertebral disc after implantation; (6) There is an elastic protective film on the outside of the nucleus pulposus material, which can Effectively prevent the growth of human soft tissue.
所述的弹性体髓核材料与上、下终板的一体化原位成型，是先将弹性体或弹性体前驱体置入上下刚性终板间，通过弹性体或弹性体前驱体的固化交联反应，与上、下刚性终板紧密地固接。所用弹性体髓核材料成型前具有良好的流动性，可充满上、下刚性终板中设置的空腔、凹槽、孔洞等结构中，形成弹性体-刚性终板相互嵌合包覆的一体式结构。在人工颈椎间盘的活动中，不存在刚性终板与弹性体髓核的摩擦界面，可以有效降低效降低或消除刚性终板与髓核材料因界面摩擦造成的材料破坏及磨屑隐患。The integrated in-situ molding of the elastomeric nucleus pulposus material and the upper and lower endplates is to firstly place the elastomer or elastomer precursor between the upper and lower rigid endplates, and through the solidification and exchange of the elastomer or the elastomer precursor, Joint reaction, tightly fixed with the upper and lower rigid endplates. The elastomeric nucleus pulposus material used has good fluidity before molding, and can fill the cavities, grooves, holes and other structures set in the upper and lower rigid endplates, forming an integrated body of elastomer-rigid endplates that fit together and cover each other formula structure. During the activity of the artificial cervical intervertebral disc, there is no friction interface between the rigid endplate and the elastomeric nucleus pulposus, which can effectively reduce or eliminate the hidden dangers of material damage and wear debris caused by the friction between the rigid endplate and the nucleus pulposus material.
所述的弹性体髓核材料成型后具有较高的强度(20MPa以上)，能够满足长时间的承载载荷的条件；具有较高的弹性变形(200％以上)，可以通过弹性体自身的变形有效模拟人体颈椎间盘在旋转、屈伸、平移三维六个自由度空间的活动性；压缩永久变形(GB/T7759-1996)较低(10％以下)，保证长时间植入人体后，人工颈椎间盘不会有明显的高度变化，有效避免椎间下沉。The elastomeric nucleus pulposus material has higher strength (more than 20MPa) after molding, and can meet the conditions of long-term load bearing; it has higher elastic deformation (more than 200%), and can be effectively deformed by the deformation of the elastomer itself. Simulate the mobility of the human cervical intervertebral disc in the three-dimensional six-degree-of-freedom space of rotation, flexion and extension, and translation; the compression set (GB/T7759-1996) is low (less than 10%), ensuring that the artificial cervical intervertebral disc will not be damaged after long-term implantation in the human body. There will be obvious height changes to effectively avoid intervertebral subsidence.
所述上、下刚性终板中，与椎骨接触的一侧的横截面为与椎骨横截面形状一致；与弹性体髓核材料接触的一侧，含有一个空腔，刚性终板的横截面为圆形或椭圆形。在上、下刚性终板空腔的中心含有一个中心凸台(1c，2c)，中心凸台的高度为1～2.5mm，中心凸台为圆柱状，从刚性终板向弹性体髓核材料方向上分为两层，靠近弹性体髓核材料中心的凸台半径大于靠近刚性终板的凸台半径。中心凸台上含有孔、槽结构，上、下刚性终板空腔的内表面上含有凹槽(1d，2d)结构和凸起结构(1e，2e)，这些凹槽结构和凸起结构或以非连续状均匀分布于刚性终板内表面，或以连续的同心环状分布于刚性终板内表面。这种结构的设计，增加了弹性体髓核材料与刚性终板的接触面积，在弹性体髓核与刚性终板一体化原位成型后，可以实现弹性体髓核材料与刚性终板更牢固的结合。在上下刚性终板的空腔的外侧，分别分布有4～8个类似于孔1f和孔2f的贯通的孔，在上下刚性终板空腔中靠近弹性体髓核的一侧，分别分布有4～8个类似于孔1g和孔2g的贯通的孔。在一体化原位成型过程中，具有流动性的弹性体或前驱体能够充满上、下刚性终板空腔内表面的凹槽、凸起及外壁和下侧结构的贯通孔，形成弹性体-刚性终板相互嵌合包覆的一体式结构，有效避免人工颈椎间盘在长时间使用时产生因界面摩擦造成的材料破坏及磨屑隐患。Among the upper and lower rigid endplates, the cross-section of the side in contact with the vertebra is consistent with the shape of the cross-section of the vertebra; the side in contact with the elastomeric nucleus pulposus material contains a cavity, and the cross-section of the rigid endplate is round or oval. There is a central boss (1c, 2c) in the center of the cavity of the upper and lower rigid endplates. The height of the central boss is 1-2.5mm. The central boss is cylindrical, extending from the rigid endplate to the elastic nucleus pulposus material It is divided into two layers in the direction, and the radius of the boss near the center of the elastomeric nucleus material is larger than the radius of the boss near the rigid endplate. The central boss contains holes and grooves, and the inner surfaces of the upper and lower rigid endplate cavities contain grooves (1d, 2d) and protrusions (1e, 2e). These grooves and protrusions or Distribute evenly on the inner surface of the rigid endplate in a discontinuous shape, or distribute on the inner surface of the rigid endplate in a continuous concentric ring. The design of this structure increases the contact area between the elastomeric nucleus pulposus material and the rigid endplate. After the elastomeric nucleus pulposus and the rigid endplate are integrated in situ, the elastomeric nucleus pulposus material and the rigid endplate can be more firmly established. combination. On the outside of the cavities of the upper and lower rigid endplates, there are 4 to 8 through holes similar to holes 1f and 2f, respectively. In the cavities of the upper and lower rigid endplates, there are respectively distributed 4 to 8 through holes similar to holes 1g and 2g. During the integrated in-situ molding process, the fluid elastomer or precursor can fill the grooves and protrusions on the inner surface of the upper and lower rigid endplate cavities, as well as the through holes in the outer wall and the lower side structure, forming an elastomer- The one-piece structure of the rigid endplates interfitting and covering each other can effectively avoid the hidden dangers of material damage and wear debris caused by interface friction when the artificial cervical intervertebral disc is used for a long time.
所述上刚性终板与椎骨接触的表面(1a)为弧面，弧面的半径范围为10～30mm，下刚性终板与椎骨接触的表面(2a)为平面或弧面半径在30～100mm范围内的弧面。上、下刚性终板表面的形状设计，可以使其与人体椎骨的骨性终板表面的形状一致，植入时避免大量的椎骨的打磨，保证人工颈椎间盘与人体椎骨具有较大的接触面，有效防止假体下沉，保留尽可能多的骨性终板，实现可翻修性。上、下刚性终板与椎骨接触的表面布有突刺(1b)或锯齿状稳定齿(2b)。所述突刺为三棱锥或四棱锥，高度为0.5～2mm，分布数量为4～10个。所述的锯齿状稳定齿结构中稳定齿沿A-C方向排列，共有两排，每排的锯齿数量为3～6个，锯齿的高度为0.5～2mm。这些突刺或锯齿状稳定尺的设计，有效保证人工颈椎间盘植入人体后的即刻稳定性，避免移位、脱出的可能。在上、下刚性终板与椎骨接触的表面含有钛和羟基磷灰石涂层中的一种或两种，通过这种喷涂，一是可以引入粗糙表面，利于人体骨的长入，二是可以促进骨的生长。The surface (1a) of the upper rigid endplate in contact with the vertebrae is an arc surface with a radius of 10-30 mm, and the surface (2a) of the lower rigid endplate in contact with the vertebra is a plane or the radius of the arc surface is 30-100 mm arcs in the range. The shape design of the upper and lower rigid endplate surfaces can make it consistent with the shape of the bony endplate surface of human vertebrae, avoiding a large number of vertebrae grinding during implantation, and ensuring a large contact surface between the artificial cervical intervertebral disc and human vertebrae , effectively prevent the prosthesis from sinking, retain as much bony endplate as possible, and achieve revisionability. The surfaces of the upper and lower rigid endplates in contact with the vertebrae are covered with spurs (1b) or serrated stabilizing teeth (2b). The spines are triangular pyramids or quadrangular pyramids, the height is 0.5-2 mm, and the distribution number is 4-10. In the sawtooth-shaped stabilizing tooth structure, the stabilizing teeth are arranged along the direction A-C, and there are two rows in total. The number of sawtooth in each row is 3-6, and the height of the sawtooth is 0.5-2mm. The design of these spikes or serrated stabilizing rulers can effectively ensure the immediate stability of the artificial cervical intervertebral disc implanted in the human body, avoiding the possibility of displacement and prolapse. One or both of titanium and hydroxyapatite coatings are included on the surface of the upper and lower rigid endplates in contact with the vertebrae. Through this spraying, one can introduce a rough surface, which is beneficial to the growth of human bones, and the other is Can promote bone growth.
在所述的人工颈椎间盘的上、下刚性终板之间，设计有弹性体限位结构(3a)，其材料与弹性体髓核材料相同，上、下刚性终板外壁和下侧结构设计的贯通孔连接为一起。弹性体限位结构从外侧向内侧呈一定斜面，斜面与水平面的夹角(α)范围为2～10°。这种结构一方面对内部弹性体髓核材料起到进一步固定的作用，另一方面当人工颈椎间盘的活动度达到一定程度后，可以对人工颈椎间盘实现弹性限位，有效避免因人工颈椎间盘活动度过大引起的邻近关节的损伤。与传统人工椎间盘的设计不同，这种限位结构具有弹性，在上、下刚性终板上的弹性体限位结构接触开始后，通过弹性体自身的变形，人工颈椎间盘的活动度可进一步增大，但增大的受到的阻力会逐渐增大，最终起到限位的作用，整个限位过程可以非常平稳的通过逐渐过渡的方式完成。这种限位结构可以使得人工颈椎间盘更好的匹配人体颈椎间盘的载荷-形变曲线，做到更好的仿生效果。Between the upper and lower rigid endplates of the artificial cervical intervertebral disc, an elastic body limiting structure (3a) is designed. The through-holes are connected together. The elastic body limiting structure forms a certain slope from the outside to the inside, and the angle (α) between the slope and the horizontal plane ranges from 2° to 10°. On the one hand, this structure can further fix the internal elastomeric nucleus pulposus material; on the other hand, when the activity of the artificial cervical intervertebral disc reaches a certain level, it can achieve elastic limit for the artificial cervical intervertebral disc, effectively avoiding the artificial cervical intervertebral disc Damage to adjacent joints caused by excessive mobility. Different from the design of the traditional artificial intervertebral disc, this limiting structure is elastic. After the elastic body limiting structure on the upper and lower rigid endplates contacts, the mobility of the artificial cervical intervertebral disc can be further increased through the deformation of the elastic body itself. Large, but the increased resistance will gradually increase, and finally play the role of limit, the whole limit process can be completed very smoothly through a gradual transition. This limiting structure can make the artificial cervical intervertebral disc better match the load-deformation curve of the human cervical intervertebral disc, achieving better bionic effects.
在所述的人工颈椎间盘髓核的外侧，包有一层具有弹性的高分子膜，膜的厚度范围为0.2～1mm。弹性的高分子膜的设计能够有效防止人体软组织地长入。The outer side of the artificial cervical intervertebral disc nucleus is covered with a layer of elastic polymer membrane, the thickness of which ranges from 0.2 to 1mm. The design of the elastic polymer membrane can effectively prevent the growth of human soft tissue.
所述的人工颈椎间盘可通过弹性体髓核材料的弹性变形实现旋转、屈伸、平移三维六个自由度空间的活动，旋转的最大角度范围不低于50°，屈伸最大角度范围不低于15°，平移最大位移不低于1mm，弹性体髓核材料能够长时间承载载荷，有效地缓冲震动，通过自身的弹性变形，很好地模拟实现人体颈椎间盘的各项机能。The artificial cervical intervertebral disc can realize rotation, flexion and extension, and translation in three-dimensional six-degree-of-freedom space through the elastic deformation of the elastomeric nucleus pulposus material. The maximum angle range of rotation is not less than 50°, and the maximum angle range of flexion and extension is not less than 15°. °, the maximum translational displacement is not less than 1mm, the elastomeric nucleus pulposus material can bear the load for a long time, effectively buffer the vibration, and through its own elastic deformation, it can well simulate and realize various functions of the human cervical intervertebral disc.
附图说明Description of drawings
下面结合附图及具体实施方式对本发明做进一步说明。The present invention will be further described below in conjunction with the accompanying drawings and specific embodiments.
图1是人工颈椎间盘原位一体化原位成型示意图。Fig. 1 is a schematic diagram of in-situ integrated in-situ forming of an artificial cervical intervertebral disc.
图2是本发明中优选实施例外观结构图。Fig. 2 is an appearance structure diagram of a preferred embodiment of the present invention.
图3是本发明中的弹性限位结构示意图。Fig. 3 is a schematic diagram of the elastic limit structure in the present invention.
图4是本发明中优选实施例的上刚性终板俯视图。Fig. 4 is a top view of the upper rigid endplate of the preferred embodiment of the present invention.
图5是本发明中优选实施例的上刚性终板仰视图。Fig. 5 is a bottom view of the upper rigid endplate of the preferred embodiment of the present invention.
图6是本发明中优选实施例的下刚性终板仰视图。Fig. 6 is a bottom view of the lower rigid endplate of the preferred embodiment of the present invention.
图7是本发明中优选实施例的下刚性终板俯视图。Fig. 7 is a top view of the lower rigid endplate of the preferred embodiment of the present invention.
图8是本发明中人工颈椎间盘的外包膜材料结构图。Fig. 8 is a structural diagram of the outer envelope material of the artificial cervical intervertebral disc in the present invention.
图9是本发明中优选实施例植入椎骨后的示意图。Fig. 9 is a schematic diagram of the preferred embodiment of the present invention after being implanted into the vertebrae.
图10是本发明示意图。Fig. 10 is a schematic diagram of the present invention.
具体实施方式detailed description
图1是本发明中人工颈椎间盘的一体化原位成型示意图。成型过程中，首先将上刚性终板、下刚性终板置于封闭模具中，然后合模，将具有良好流动性的弹性体或弹性体前驱体从浇注口a注入模腔中，充满上、下刚性终板之间的空腔缝隙中，然后在一定温度下原位固化反应，与上、下刚性终板形成相互嵌合包覆的一体式结构，然后将弹性体外薄膜材料固定到人工颈椎间盘中，得到最终的人工颈椎间盘产品。图2为其中一个优选实施例的外观结构图，图2中，结构1为上刚性终板，结构2为下刚性终板，结构3为弹性体髓核材料，结构4为半透明的弹性体包膜材料。Fig. 1 is a schematic diagram of the integrated in situ forming of the artificial cervical intervertebral disc in the present invention. During the molding process, first place the upper rigid endplate and the lower rigid endplate in the closed mold, then close the mold, inject the elastomer or elastomer precursor with good fluidity into the mold cavity from the gate a, and fill the upper and lower rigid endplates. In the cavity gap between the lower rigid endplates, it will be cured in situ at a certain temperature to form a one-piece structure that fits and covers each other with the upper and lower rigid endplates, and then the elastomeric outer film material is fixed to the artificial neck In the intervertebral disc, the final artificial cervical intervertebral disc product is obtained. Figure 2 is the appearance structure diagram of one of the preferred embodiments, in Figure 2, structure 1 is the upper rigid endplate, structure 2 is the lower rigid endplate, structure 3 is the elastomeric nucleus pulposus material, and structure 4 is the translucent elastomer Envelope material.
在本发明所涉及的人工颈椎间盘中，设计了弹性限位结构。图3为弹性限位结构在工作时的示意图。弹性限位结构(3a)通过上、下刚性终板上贯通的孔结构与弹性体髓核材料连为一个整体，其由外到内成一定斜面，当人工颈椎间盘在前驱、后伸、侧弯等方向上达到设定的最大角度β时，上、下刚性终板上的限位结构的斜面贴合到一起，从而对人工颈椎间盘起到弹性限位的效果。在结构上，虽然弹性限位结构通过贯通孔结构与弹性体髓核材料相连接，但在中心弹性体髓核材料承受载荷并通过变形实现人工颈椎间盘在各个方向上的活动度时，弹性体限位结构通过上、下刚性终板阻隔结构的设计，基本不参与受力与变形，只有在人工颈椎间盘活动达到极限后，参与弹性限位作用，避免因人工颈椎间盘活动过大对邻近关节的损伤。In the artificial cervical intervertebral disc involved in the present invention, an elastic limiting structure is designed. Fig. 3 is a schematic diagram of the elastic limit structure in operation. The elastic limiting structure (3a) is connected as a whole with the elastic nucleus pulposus material through the hole structure through the upper and lower rigid endplates, and it forms a certain slope from outside to inside. When the set maximum angle β is reached in the direction of bending, etc., the slopes of the limiting structures on the upper and lower rigid endplates fit together, thereby exerting the effect of elastically limiting the artificial cervical intervertebral disc. Structurally, although the elastic limit structure is connected with the elastomeric nucleus pulposus material through the through-hole structure, when the central elastomeric nucleus pulposus material bears the load and realizes the mobility of the artificial cervical intervertebral disc in all directions through deformation, the elastic body Through the design of the upper and lower rigid endplate barrier structures, the limit structure basically does not participate in the force and deformation, and only participates in the elastic limit function after the activity of the artificial cervical intervertebral disc reaches the limit, so as to avoid the damage to the adjacent joints caused by the excessive activity of the artificial cervical intervertebral disc. damage.
图4与图6分别为本发明中一些优选实施例的上刚性终板俯视图和下刚性终板的仰视图。上、下刚性终板的轮廓结构与人体椎骨的轮廓结构相似，保证人工颈椎间盘与人体椎骨具有最大的接触面积。以上刚性终板为例，在上刚性终板与人体椎骨接触的表面上，均匀地喷涂有利于骨长入的钛或羟基磷灰石涂层，如图4a1所示。在上刚性终板的表面上，设置有两排锯齿形稳定齿(4a2)或突刺类稳定齿(4b1，4f1)，其中的一些设计及分布可见图4a～图4f。下刚性终板与人体椎骨的接触面的设计与上刚性终板相似，喷涂有有利于骨长入的钛或羟基磷灰石涂层，设置有两排锯齿形稳定齿或突刺类稳定齿结构，其中的一些设计及分布可见图6a～图6f。这样的稳定齿的设计，可以有效保证人工颈椎间盘植入人体后，具有较好的即刻稳定性。Figure 4 and Figure 6 are respectively a top view of the upper rigid endplate and a bottom view of the lower rigid endplate of some preferred embodiments of the present invention. The outline structure of the upper and lower rigid endplates is similar to that of the human vertebrae, ensuring the largest contact area between the artificial cervical intervertebral disc and the human vertebrae. The above rigid endplate is taken as an example. On the surface of the upper rigid endplate in contact with human vertebrae, a titanium or hydroxyapatite coating that is conducive to bone ingrowth is evenly sprayed, as shown in Figure 4a1. On the surface of the upper rigid endplate, there are two rows of saw-tooth-shaped stabilizing teeth (4a2) or spur-like stabilizing teeth (4b1, 4f1), some of which are designed and distributed as shown in Figs. 4a-4f. The design of the contact surface between the lower rigid endplate and the human vertebrae is similar to that of the upper rigid endplate. It is sprayed with titanium or hydroxyapatite coating that is conducive to bone ingrowth, and is equipped with two rows of sawtooth-shaped stable teeth or spur-like stable tooth structures , some of the designs and distributions can be seen in Figures 6a to 6f. The design of such stabilizing teeth can effectively ensure that the artificial cervical intervertebral disc has better immediate stability after it is implanted into the human body.
图5与图7分别为本发明中一些优选实施例的上刚性终板仰视图和下刚性终板的俯视图。对于上刚性终板，图5a1为上刚性终板与弹性体髓核材料接触一侧的含空腔的终板结构，其外侧轮廓为圆形(5a，5b，5d)或椭圆形(5c，5e，5f)，内侧轮廓为圆形、椭圆形或方形。在空腔外侧结构上设计有上下贯通的孔结构(图5a2)，这些贯通的孔为圆形或椭圆形，均匀地分布于下侧结构中。图5a5为空腔中心的圆柱型凸台结构，在上刚性终板的空腔中心的凸台的周围分布有大量的小凸起或凹槽，这些凹槽或凸起或以离散的形式均匀分布在空腔内侧(图5a3，5a4)，或以同心环的方式分布于空腔内侧(图5b1，5c1)。对于下刚性终板，其与弹性体髓核材料接触一侧的设计结构基本与上终板一致，图7a1为上刚性终板与弹性体髓核材料接触一侧的含空腔的终板结构，其外侧轮廓为圆形(7a，7b，7d)或椭圆形(7c，7e，7f)，内侧轮廓为圆形、椭圆形或方形。在空腔外侧结构上设计有上下贯通的孔结构(图7a2)，这些贯通的孔为圆形或椭圆形，均匀地分布于下侧结构中。图7a5为空腔中心的圆柱型凸台结构，在上刚性终板的空腔中心的凸台的周围分布有大量的小凸起或凹槽，这些凹槽或凸起或以离散的形式均匀分布在空腔内侧(图7a3，7a4)，或以同心环的方式分布于空腔内侧(图7b1，7c1)。这种凸起或凹槽的设计，大大增加了弹性体髓核材料与上、下刚性终板的接触面积，更好地实现弹性体髓核与刚性终板的牢固结合。Fig. 5 and Fig. 7 are respectively the bottom view of the upper rigid endplate and the top view of the lower rigid endplate of some preferred embodiments of the present invention. For the upper rigid endplate, Figure 5a1 shows the cavity-containing endplate structure on the side where the upper rigid endplate is in contact with the elastomeric nucleus material, and its outer contour is circular (5a, 5b, 5d) or oval (5c, 5e, 5f), the inner contour is round, oval or square. The outer structure of the cavity is designed with a hole structure that penetrates up and down (Fig. 5a2). These through holes are circular or elliptical, and are evenly distributed in the lower structure. Figure 5a5 shows the cylindrical boss structure in the center of the cavity. There are a large number of small protrusions or grooves distributed around the boss in the center of the cavity of the upper rigid endplate. These grooves or protrusions are even in a discrete form. Distributed inside the cavity (Figure 5a3, 5a4), or distributed in the inside of the cavity in the form of concentric rings (Figure 5b1, 5c1). For the lower rigid endplate, the design structure of the side in contact with the elastomeric nucleus pulposus material is basically the same as that of the upper endplate. Figure 7a1 shows the cavity-containing endplate structure on the side of the upper rigid endplate in contact with the elastomeric nucleus pulposus material , its outer contour is circular (7a, 7b, 7d) or oval (7c, 7e, 7f), and its inner contour is circular, oval or square. On the outer structure of the cavity, there are vertically through-hole structures (Fig. 7a2). These through-holes are circular or elliptical, and are evenly distributed in the lower structure. Figure 7a5 shows the cylindrical boss structure in the center of the cavity. There are a large number of small protrusions or grooves distributed around the boss in the center of the cavity of the upper rigid endplate. These grooves or protrusions are even in a discrete form. Distributed inside the cavity (Figure 7a3, 7a4), or distributed in the inside of the cavity in the form of concentric rings (Figure 7b1, 7c1). The design of such protrusions or grooves greatly increases the contact area between the elastomeric nucleus pulposus material and the upper and lower rigid endplates, and better realizes the firm combination of the elastomeric nucleus pulposus and the rigid endplates.
图8为本发明中人工颈椎间盘的外包膜材料结构图，外薄膜的结构或为向外凸的结构(图8a)，或为向内凹的结构(图8b)，或为折叠式结构(图8c)，其横截面为圆形(图8d)或椭圆形(图8e)。Figure 8 is a structure diagram of the outer envelope material of the artificial cervical intervertebral disc in the present invention, the structure of the outer film is either a convex structure (Figure 8a), or a concave structure (Figure 8b), or a folded structure (Fig. 8c), and its cross-section is circular (Fig. 8d) or elliptical (Fig. 8e).
图9为本发明中的人工颈椎间盘植入人体后的示意图。图9a，9c为与人工颈椎间盘接触的人体椎骨，图9b为本发明中的人工颈椎间盘。人工颈椎间盘的上刚性终板和下刚性终板设计的弧面与接触的人体椎骨的弧面相似，在植入后，人工颈椎间盘与人体椎骨具有较大的接触面。人工颈椎间盘表面上的稳定齿结构刺入人体椎骨中，可保证植入后人工颈椎间盘具有非常好的即刻稳定性。Fig. 9 is a schematic diagram of the artificial cervical intervertebral disc of the present invention after being implanted into a human body. Figures 9a and 9c are human vertebrae in contact with the artificial cervical intervertebral disc, and Figure 9b is the artificial cervical intervertebral disc in the present invention. The curved surfaces of the upper rigid endplate and the lower rigid endplate of the artificial cervical intervertebral disc are similar to those of the contacting human vertebrae. After implantation, the artificial cervical intervertebral disc has a larger contact surface with the human vertebrae. The stabilizing tooth structure on the surface of the artificial cervical intervertebral disc penetrates into the human vertebrae, which can ensure the immediate stability of the artificial cervical intervertebral disc after implantation.
本发明中设计的人工颈椎间盘，采用原位一体化成型的设计，通过弹性体髓核材料的弹性变形，能够很好地模拟颈椎间盘在各个方向上的运动，具有非常好的性能仿生的特点。本发明中的人工颈椎间盘结构设计不仅仅局限于颈椎间盘，通过结构上的略微调整，也可应用于人工腰椎间盘的设计。The artificial cervical intervertebral disc designed in the present invention adopts the design of in-situ integrated molding, through the elastic deformation of the elastomeric nucleus pulposus material, it can well simulate the movement of the cervical intervertebral disc in all directions, and has very good bionic performance characteristics . The structural design of the artificial cervical intervertebral disc in the present invention is not limited to the cervical intervertebral disc, but can also be applied to the design of the artificial lumbar intervertebral disc through slight structural adjustments.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610031666.2ACN105708584B (en) | 2016-01-18 | 2016-01-18 | A kind of integral type biomimetic type cervical artificial disc |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610031666.2ACN105708584B (en) | 2016-01-18 | 2016-01-18 | A kind of integral type biomimetic type cervical artificial disc |
| Publication Number | Publication Date |
|---|---|
| CN105708584Atrue CN105708584A (en) | 2016-06-29 |
| CN105708584B CN105708584B (en) | 2018-08-10 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201610031666.2AActiveCN105708584B (en) | 2016-01-18 | 2016-01-18 | A kind of integral type biomimetic type cervical artificial disc |
| Country | Link |
|---|---|
| CN (1) | CN105708584B (en) |
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| CP03 | Change of name, title or address | Address after:214112 No. 19 Zhang highway, new Wu District, Wuxi, Jiangsu Co-patentee after:Beijing University of Chemical Technology Patentee after:Wuxi Baotong Investment Co., Ltd. Address before:214112 No. 19 Zhang Road, Wuxi City, Jiangsu Province Co-patentee before:Beijing University of Chemical Technology Patentee before:WUXI BAOTONG MEDICAL INVESTMENT CO., LTD. |