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CN104644290A - Porous total knee prosthesis - Google Patents

Porous total knee prosthesis Download PDF

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Publication number
CN104644290A
CN104644290A CN201310578654.8A CN201310578654A CN104644290A CN 104644290 A CN104644290 A CN 104644290A CN 201310578654 A CN201310578654 A CN 201310578654A CN 104644290 A CN104644290 A CN 104644290A
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porous
femur
prosthesis
prosthese
knee joint
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尚鹏
张黎楠
谢耀钦
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Shenzhen Institute of Advanced Technology of CAS
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Shenzhen Institute of Advanced Technology of CAS
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Abstract

多孔人工膝关节,包括股骨踝假体、人工半月板和胫骨托假体,所述股骨踝假体实心主体部分设有连接孔,其与病人的股骨相结合的表面覆设有可与股骨骨质结合起固定作用的第一多孔固定层;第一多孔固定层与病人的股骨相对的表面形成包住截骨后的股骨端的结构,与股骨相背的表面对称设有两股骨关节面;所述人工半月板具有与连接孔配合且用于防止股骨踝假体脱位的突起、与股骨关节面配合的胫骨关节面、与胫骨托假体配合的连接部;所述胫骨托假体上端具有与连接部配合的定位部,下端支承部外表面覆设有第二多孔固定层,胫骨结合面表面还覆设有第三多孔固定层。本发明的人工膝关节与病人股骨骨质结合力强,有利于骨组织长入,可实现较优的生物学固定效果。

The porous artificial knee joint includes a femoral ankle prosthesis, an artificial meniscus and a tibial tray prosthesis. The solid main part of the femoral ankle prosthesis is provided with connection holes, and the surface combined with the patient's femur is covered with a The surface of the first porous fixation layer opposite to the patient's femur forms a structure that encloses the end of the femur after osteotomy, and the surface opposite to the femur is symmetrically provided with two femoral articular surfaces ; The artificial meniscus has a protrusion that cooperates with the connection hole and is used to prevent the dislocation of the femoral ankle prosthesis, the tibial articular surface that cooperates with the femoral articular surface, and the connecting portion that cooperates with the tibial support prosthesis; the upper end of the tibial support prosthesis It has a positioning part matched with the connecting part, the outer surface of the lower end supporting part is covered with a second porous fixing layer, and the surface of the tibial joint is also covered with a third porous fixing layer. The artificial knee joint of the present invention has strong bonding force with the patient's femur bone, is conducive to the growth of bone tissue, and can realize a better biological fixation effect.

Description

多孔人工膝关节Porous artificial knee joint

技术领域technical field

本发明涉及医疗器械领域,具体涉及任何人机交互式(又称被动式)机械臂和机器人的球关节锁紧方法及装置。The invention relates to the field of medical devices, in particular to any man-machine interactive (also known as passive) mechanical arm and ball joint locking method and device for a robot.

背景技术Background technique

人工膝关节置换术目前已经成为治疗关节终末期疾病和老年股骨颈骨折的治疗手段,明显提高了患者的生活质量。全世界每年接受因关节炎导致的关节丧失功能患者进行人工关节置换手术的数量约150万。人工髋关节置换可以更好地缓解疼痛,改善关节功能,恢复关节的稳定和肢体的功能,已经得到广大患者的认同。Artificial knee arthroplasty has become a treatment for end-stage joint diseases and femoral neck fractures in the elderly, and it has significantly improved the quality of life of patients. Every year, about 1.5 million artificial joint replacement operations are performed on patients with joint loss of function caused by arthritis in the world. Artificial hip replacement can better relieve pain, improve joint function, restore joint stability and limb function, and has been recognized by the majority of patients.

人体膝关节在负重的情况下同时承受拉力、压力、扭转和界面剪切及反复疲劳、磨损等力的作用,因此要求植入的胫骨和股骨踝假体必须与骨之间牢牢固定。The human knee joint is subjected to tension, pressure, torsion, interface shear, repeated fatigue, wear and other forces under load. Therefore, it is required that the implanted tibial and femoral ankle prosthesis must be firmly fixed to the bone.

人工膝关节一般由三个部件组成:股骨踝假体、人工半月板、胫骨托假体。人工半月板位于股骨踝假体和胫骨托假体中间,可以在股骨和胫骨托假体之间传导负荷。The artificial knee joint generally consists of three components: femoral ankle prosthesis, artificial meniscus, and tibial support prosthesis. The artificial meniscus is located between the femoral ankle prosthesis and the tibial tray prosthesis, and can transmit load between the femoral and tibial tray prosthesis.

传统的人工膝关节主体和表面均为无孔致密的结构,通常采用增大表面粗糙度,实现提高与骨骼之间的摩擦结合的目的。长期随访资料表明,约有10%的患者在初次人工关节置换术后15年内需要进行人工关节翻修术。人工关节假体无菌性松动是人工关节置换术后最常见的并发症之一,也是限制人工关节使用寿命的主要影响因素。假体一旦发生松动,会引起疼痛、关节功能障碍等问题,更甚者需要进行翻修术。The main body and surface of traditional artificial knee joints are non-porous and dense structures, and the surface roughness is usually increased to achieve the purpose of improving the frictional combination with the bone. Long-term follow-up data show that about 10% of patients need artificial joint revision within 15 years after the initial artificial joint replacement. Aseptic loosening of artificial joint prosthesis is one of the most common complications after artificial joint replacement, and it is also the main factor that limits the service life of artificial joints. Once the prosthesis loosens, it will cause pain, joint dysfunction and other problems, and even require revision surgery.

因此,如何使得植入假体能尽快获得骨性固定,被认为是预防人工膝关节松动的关键。目前人工关节假体的固定,指的是胫骨托假体和股骨踝假体如何与骨固定。固定方式大体分为骨水泥固定和生物学固定两种类型。但是,这两种固定方式都存在诸多问题。Therefore, how to obtain bony fixation of the implanted prosthesis as soon as possible is considered to be the key to preventing artificial knee joint loosening. At present, the fixation of artificial joint prosthesis refers to how the tibial tray prosthesis and the femoral ankle prosthesis are fixed to the bone. Fixation methods can be roughly divided into two types: bone cement fixation and biological fixation. However, there are many problems in these two fixing methods.

骨水泥固定,通过在安装假体与骨床之间充填骨水泥,形成假体--骨水泥和骨水泥--骨两个界面,使得假体固定在骨水泥中。骨水泥固定都存在骨水泥疲劳,使得骨水泥在维持人工关节的长期稳定性上的结果并不理想,常常出现“骨水泥病”,也即人工关节松动和骨溶解。但若病人的骨质质量差、使用假体的寿命短、活动强度较低等情况,建议使用骨水泥固定。但骨水泥固定,因存在骨水泥疲劳,使得骨水泥在维持人工关节的长期稳定性上的结果并不理想,常常出现“骨水泥病”,也即人工关节松动和骨溶解。Bone cement fixation, by filling the bone cement between the installed prosthesis and the bone bed, two interfaces of the prosthesis-bone cement and bone cement-bone are formed, so that the prosthesis is fixed in the bone cement. Bone cement fixation has bone cement fatigue, which makes the effect of bone cement in maintaining the long-term stability of artificial joints unsatisfactory, and "bone cement disease" often occurs, that is, artificial joint loosening and osteolysis. However, if the patient's bone quality is poor, the life of the prosthesis is short, and the activity intensity is low, it is recommended to use bone cement for fixation. But bone cement fixation, due to the existence of bone cement fatigue, makes the effect of bone cement in maintaining the long-term stability of artificial joints unsatisfactory, and "bone cement disease" often occurs, that is, artificial joint loosening and osteolysis.

生物学固定,又称非骨水泥固定,是通过人工关节假体的多孔表面与骨紧密接触,实现骨长入达到生物闭锁的一种固定方式。生物学固定假体在植入初期依赖于假体的外形与骨床的紧密压配,而在骨长入阶段,则取决于假体的表面处理效果,假体表面的多孔表面/涂层决定了假体与骨的结合方式,从而决定了固定的牢固程度。生物学固定表面多孔主要分为以下两种:(1)巨孔型表面(如珊瑚面型、珍珠面型),具有巨孔型表面的假体与骨结合只是机械性“二维”固定,仅通过改变骨-假体表面的剪切力变为压应力来实现固定,此方式提高强度有限。(2)微孔型固定,又分为二维表面微孔和三维多孔设计。二维表面微孔大多是通过金属珠粒烧结、喷砂、微弧氧化等方法实现表面的微孔结构(孔径多为微米级,孔层连通率差),有研究结果表明,适宜于骨长入的孔径在150-700微米之间,当孔径小于100微米时,长入孔内的只是纤维组织,而非骨组织。因此二维表面的微孔不能提供骨长入,只有“骨长上”现象,其界面结合强度和骨诱导能力较差;而三维多孔表面多是通过等离子喷涂、化学气相沉积等方法实现的(孔径在100-700微米,孔隙率约为25%~75%),比二维多孔表面具有更强的骨诱导能力和界面结合强度,但在大量临床使用上并未获得良好的固定效果,随着临床返修的病例,其缺陷逐渐暴露出来,由于涂层和假体的结合力弱,出现涂层剥脱、断裂以及颗粒形成等原因致使假体松动。前瞻性研究表明,羟基磷灰石(HA)涂层假体在中期有5%的松动率,明显大于单纯骨水泥固定假体,且假体周围的骨结合并不连续。安装这类人工关节时,要充分保证人工关节与放入的骨腔要大小匹配的非常好,不能留有空隙,同时骨腔内的骨质也要有较好的支撑和初期的固定作用,才能使人工关节稳定,便于以后骨质的长入。非骨水泥型人工髋关节如果发生松动,只是会出现脱节现象,对骨组织的腐蚀性弱,骨组织的缺失量少,易于翻修。Biological fixation, also known as non-cemented fixation, is a fixation method in which the porous surface of the artificial joint prosthesis is in close contact with the bone to achieve bone ingrowth to achieve biological atresia. Biological fixed prosthesis depends on the shape of the prosthesis and the tight press fit of the bone bed at the initial stage of implantation, while in the stage of bone ingrowth, it depends on the surface treatment effect of the prosthesis, which is determined by the porous surface/coating on the surface of the prosthesis. It determines how the prosthesis is combined with the bone, thus determining the firmness of the fixation. Biological fixation surfaces are mainly porous into the following two types: (1) Megaporous surfaces (such as coral face, pearl face), prostheses with megaporous surfaces and osseointegration are only mechanically "two-dimensional" fixation, Fixation is achieved only by changing the shear force on the surface of the bone-prosthesis into compressive stress, which has limited strength enhancement. (2) Microporous fixation is divided into two-dimensional surface microporous and three-dimensional porous design. Most of the micropores on the two-dimensional surface are sintered by metal beads, sandblasting, micro-arc oxidation and other methods to realize the microporous structure on the surface (the pore diameter is mostly micron, and the connectivity of the pore layer is poor). The pore size of the hole is between 150-700 microns. When the pore size is less than 100 microns, only fibrous tissue grows into the hole, not bone tissue. Therefore, the micropores on the two-dimensional surface cannot provide bone ingrowth, only the phenomenon of "bone growth", and its interface bonding strength and osteoinductive ability are poor; while the three-dimensional porous surface is mostly realized by plasma spraying, chemical vapor deposition and other methods ( The pore size is 100-700 microns, and the porosity is about 25%-75%), which has stronger osteoinductive ability and interface bonding strength than the two-dimensional porous surface, but it has not obtained good fixation effect in a large number of clinical applications. In the case of clinical repair, its defects are gradually exposed. Due to the weak bonding force between the coating and the prosthesis, the coating peels off, breaks, and the formation of particles causes the prosthesis to loosen. Prospective studies have shown that hydroxyapatite (HA) coated prosthesis has a 5% loosening rate in the medium term, which is significantly higher than that of pure bone cement fixed prosthesis, and the osseointegration around the prosthesis is not continuous. When installing this type of artificial joint, it is necessary to fully ensure that the size of the artificial joint and the bone cavity to be inserted should match very well without leaving any gaps. At the same time, the bone in the bone cavity should also have good support and initial fixation. Only in this way can the artificial joint be stabilized and facilitate the ingrowth of bone in the future. If the non-cemented artificial hip joint becomes loose, it will only appear out of joint, which is less corrosive to bone tissue, less bone tissue loss, and easy to repair.

前瞻性研究表明,目前的生物学固定假体改善了早期固定效果,但中、远期固定效果仍未改观,主要因为涂层的剥脱、断裂以及颗粒的形成等原因导致假体松动,乃至失效。Prospective studies have shown that the current biological fixation prosthesis has improved the early fixation effect, but the mid- and long-term fixation effect has not improved, mainly due to the loosening and even failure of the prosthesis due to the peeling off, fracture of the coating, and the formation of particles. .

发明内容Contents of the invention

本发明的目的在于克服上述现有技术的缺陷,提供一种与病人股骨骨质结合力强,有利于骨组织长入的人工膝关节,可实现较优的生物学固定效果。The purpose of the present invention is to overcome the above-mentioned defects of the prior art, and provide an artificial knee joint with a strong bonding force with the patient's femur bone, which is beneficial to the ingrowth of bone tissue, and can achieve a better biological fixation effect.

本发明提供的多孔人工膝关节,包括股骨踝假体、胫骨托假体及位于所述股骨踝假体和所述胫骨托假体之间的人工半月板,其特征在于,所述股骨踝假体具有实心主体部分,所述股骨踝假体的实心主体部分开设有连接孔,于所述实心主体部分与与病人的股骨相结合的表面,覆设有可与股骨骨质结合起固定作用的第一多孔固定层;于所述第一多孔固定层上,与病人的股骨相对的表面对称设有踝结合面和位于两所述踝结合面之间且位于所述连接孔两侧的踝间结合面,形成包住截骨后的股骨端的结构,所述股骨踝假体的实心主体部分与与病人的股骨相背的表面对称设有两股骨关节面;所述人工半月板具有一可与所述连接孔配合且用于防止所述股骨踝假体脱位的突起、与所述股骨关节面相配合的胫骨关节面、与所述胫骨托假体相配合的连接部;所述胫骨托假体包括胫骨髓实心主体部分,所述胫骨髓实心主体部分上端具有可与所述连接部配合的定位部,下端为支承部,该支承部外表面覆设有第二多孔固定层。The porous artificial knee joint provided by the present invention comprises a femoral ankle prosthesis, a tibial tray prosthesis and an artificial meniscus between the femoral ankle prosthesis and the tibial tray prosthesis, wherein the femoral ankle prosthesis The body has a solid main part, and the solid main part of the femoral ankle prosthesis is provided with a connection hole, and the surface of the solid main part combined with the patient's femur is covered with a bone that can be combined with the femoral bone for fixation. The first porous fixing layer; on the first porous fixing layer, the surface opposite to the patient's femur is symmetrically provided with an ankle joint surface and between the two ankle joint surfaces and on both sides of the connection hole The junction surface between the ankles forms a structure enclosing the femoral end after the osteotomy, and the solid main part of the femoral ankle prosthesis is symmetrically provided with two femoral articular surfaces on the surface facing away from the patient's femur; the artificial meniscus has a The protrusion that can cooperate with the connection hole and is used to prevent the dislocation of the femoral ankle prosthesis, the tibial articular surface that cooperates with the femoral articular surface, and the connection part that cooperates with the tibial tray prosthesis; the tibial tray The prosthesis includes a solid main body part of the tibial marrow. The upper end of the solid main part of the tibial marrow has a positioning part that can cooperate with the connecting part, and the lower end is a supporting part. The outer surface of the supporting part is covered with a second porous fixing layer.

本发明进一步的结构设计中,所述胫骨托假体上的定位部与所述支承部相对的表面为胫骨结合面,所述胫骨结合面表面覆设有第三多孔固定层。In a further structural design of the present invention, the surface of the positioning portion on the tibial tray prosthesis opposite to the support portion is the tibial joint surface, and the surface of the tibial joint surface is covered with a third porous fixing layer.

本发明具体的结构设计中,所述第一多孔固定层、所述第二多孔固定层及所述第三多孔固定层厚度0.2-3mm、孔径0.2-0.8mm、孔隙率30-90%。In the specific structural design of the present invention, the thickness of the first porous fixed layer, the second porous fixed layer and the third porous fixed layer are 0.2-3 mm, the pore diameter is 0.2-0.8 mm, and the porosity is 30-90 %.

本发明具体的结构设计中,所述人工半月板上的所述连接部包括凸台及设置于该凸台上的定位凸缘;所述胫骨托假体上的所述定位部包括与所述凸台配合的凹腔及与所述定位凸缘配合的中心槽。In the specific structural design of the present invention, the connecting portion on the artificial meniscus includes a boss and a positioning flange arranged on the boss; the positioning portion on the tibial tray prosthesis includes a The concave cavity matched with the boss and the central groove matched with the positioning flange.

本发明具体的结构设计中,所述胫骨托假体支承部具有向下呈外径渐小的锥台状结构,且沿所述锥台大端外周的轴向,向下开设有至少两个对称的条状凹槽,所述条状凹槽与锥台外周的交界处平滑过渡。In the specific structural design of the present invention, the tibial tray prosthesis bearing part has a frustum-shaped structure with a gradually smaller outer diameter downwards, and along the axial direction of the outer circumference of the large end of the frustum, there are at least two symmetrical The strip-shaped groove, the junction of the strip-shaped groove and the outer periphery of the frustum of the cone is smoothly transitioned.

本发明具体的结构设计中,所述股骨关节面为高抛光面。In the specific structural design of the present invention, the articular surface of the femur is a highly polished surface.

本发明所述股骨踝假体和胫骨托假体由钴铬钼合金、不锈钢、钛、钛合金、镍钴合金或金属钽材料制成,所述人工半月板由超高分子聚乙烯材料制成。The femoral ankle prosthesis and tibial tray prosthesis of the present invention are made of cobalt-chromium-molybdenum alloy, stainless steel, titanium, titanium alloy, nickel-cobalt alloy or metal tantalum material, and the artificial meniscus is made of ultra-high molecular polyethylene material .

本发明具体的结构设计中,所述股骨踝假体的实心主体部分两侧还设有用于与病人的股骨踝外侧结合辅助固定的定位翼。In the specific structural design of the present invention, the solid main part of the femoral ankle prosthesis is provided with positioning wings on both sides for auxiliary fixation combined with the lateral side of the patient's femoral ankle.

本发明于所述实心主体部分上,且与人体髌骨或髌骨假体接触面中间位置,设有髌骨沟,所述髌骨沟的两侧分别设有两滑车面,构成与髌骨或髌骨假体活动连接的滑车部分。The present invention is provided with a patella groove on the solid body part, and in the middle of the contact surface with the patella or the patella prosthesis of the human body, and two pulley surfaces are respectively provided on both sides of the patella groove to form a movable joint with the patella or the patella prosthesis. Connected block parts.

本发明旨在使得人工膝关节具有更优生物学固定效果(骨长入)。在股骨踝假体与病人股骨骨质相结合的表面、胫骨托假体的支承部设置可一体成型的立体多孔结构层,利用多孔固定层和膝关节假体结合强度大、多孔固定层的孔隙率高、多孔固定层的孔径利于骨组织长入等特点,使得病人骨体与假体间形成交锁结合,同时由于多孔固定层具有更强的骨诱导能力,更易于骨长入并在内连孔道中延伸交织,可克服目前人工假体利用涂层进行生物固定的不足,从而实现更优的生物学固定效果,延长人工假体的使用寿命。The present invention aims at making the artificial knee joint have a better biological fixation effect (bone ingrowth). A three-dimensional porous structure layer that can be integrally formed is provided on the surface of the femoral ankle prosthesis combined with the patient's femoral bone and the support of the tibial tray prosthesis, and the porous fixation layer and the knee joint prosthesis have high bonding strength and pores in the porous fixation layer. The characteristics of the high rate and the pore diameter of the porous fixation layer are conducive to bone tissue ingrowth, which make the interlocking combination between the patient's bone body and the prosthesis. The extension and interweaving of the connecting channels can overcome the shortcomings of the current artificial prosthesis using the coating for biological fixation, thereby achieving a better biological fixation effect and prolonging the service life of the artificial prosthesis.

附图说明Description of drawings

图1是本发明实施例提供的多孔人工膝关节装配图;Fig. 1 is the assembly diagram of the porous artificial knee joint provided by the embodiment of the present invention;

图2是本发明实施例提供的多孔人工膝关节爆炸图;Fig. 2 is an exploded diagram of the porous artificial knee joint provided by the embodiment of the present invention;

图3A是本发明实施例提供的股骨踝假体之第一多孔固定层结构示意图;3A is a schematic structural view of the first porous fixation layer of the femoral ankle prosthesis provided by the embodiment of the present invention;

图3B是本发明实施例提供的股骨踝假体之实心主体部分结构示意图;3B is a schematic structural view of the solid main part of the femoral ankle prosthesis provided by the embodiment of the present invention;

图3C是本发明实施例提供的股骨踝假体第一视角结构示意图;Fig. 3C is a schematic structural view of the first viewing angle of the femoral ankle prosthesis provided by the embodiment of the present invention;

图3D是本发明实施例提供的股骨踝假体第二视角结构示意图;Fig. 3D is a schematic structural diagram of the second viewing angle of the femoral ankle prosthesis provided by the embodiment of the present invention;

图3E是图3D之A-A剖面结构示意图;FIG. 3E is a schematic diagram of the cross-sectional structure of A-A in FIG. 3D;

图4A是本发明实施例提供的人工半月板第一视角结构示意图;Fig. 4A is a schematic structural diagram of the first viewing angle of the artificial meniscus provided by the embodiment of the present invention;

图4B是本发明实施例提供的人工半月板第二视角结构示意图;Fig. 4B is a schematic structural diagram of the second viewing angle of the artificial meniscus provided by the embodiment of the present invention;

图4C是本发明实施例提供的人工半月板第三视角结构示意图;Fig. 4C is a schematic structural diagram of the third viewing angle of the artificial meniscus provided by the embodiment of the present invention;

图5A是本发明实施例提供的胫骨托假体第一视角结构示意图;Fig. 5A is a schematic structural diagram of the first viewing angle of the tibial tray prosthesis provided by the embodiment of the present invention;

图5B是图5A之B-B结构示意图;Fig. 5B is a schematic diagram of the structure of B-B in Fig. 5A;

图5C是本发明实施例提供的胫骨托假体第二视角结构示意图;Fig. 5C is a schematic structural diagram of the second viewing angle of the tibial tray prosthesis provided by the embodiment of the present invention;

图5D是本发明实施例提供的胫骨托假体分解结构示意图;Fig. 5D is a schematic diagram of the exploded structure of the tibial tray prosthesis provided by the embodiment of the present invention;

图5E是本发明实施例提供的胫骨托假体之第二多孔固定层结构示意图。Fig. 5E is a schematic diagram of the structure of the second porous fixing layer of the tibial tray prosthesis provided by the embodiment of the present invention.

具体实施方式Detailed ways

为了使本发明的目的、技术方案及优点更加清楚明白,以下结合附图及实施例,对本发明进行进一步详细说明。应当理解,此处所描述的具体实施例仅仅用以解释本发明,并不用于限定本发明。In order to make the object, technical solution and advantages of the present invention clearer, the present invention will be further described in detail below in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described here are only used to explain the present invention, not to limit the present invention.

参见图1-图5,本发明提供了一种多孔人工膝关节,包括股骨踝假体1、胫骨托假体3及位于所述股骨踝假体1和所述胫骨托假体3之间的人工半月板2,参见图3A-图3E,其中所述的股骨踝假体具有实心主体部分12,所述股骨踝假体1的实心主体部分12开设有连接孔13,位于实心主体部分12中心位置;于所述实心主体部分12与与病人的股骨相结合的表面,覆设有可与股骨骨质结合起固定作用的第一多孔固定层11,其具有的立体多孔结构利于骨组织长入固定;所述第一多孔固定层11上,与病人的股骨相对的表面对称设有踝结合面111和位于两所述踝结合面111之间且位于所述连接孔13两侧的踝间结合面112,形成包住截骨后的股骨端的结构;于所述股骨踝假体1的实心主体部分12,且与病人的股骨相背的表面上,对称设有两股骨关节面1231,两股骨关节面1231为弧面,便于关节的转动;Referring to Fig. 1-Fig. 5, the present invention provides a kind of porous artificial knee joint, comprises femoral ankle prosthesis 1, tibial support prosthesis 3 and is positioned at described femoral ankle prosthesis 1 and described tibial support prosthesis 3 Artificial meniscus 2, see Fig. 3A-Fig. 3E, wherein said femoral ankle prosthesis has solid body part 12, and the solid body part 12 of described femoral ankle prosthesis 1 is provided with connection hole 13, is positioned at the center of solid body part 12 Position; on the surface of the solid main body part 12 combined with the patient's femur, it is covered with the first porous fixing layer 11 that can be combined with the femoral bone for fixation, and its three-dimensional porous structure is conducive to the growth of bone tissue On the first porous fixing layer 11, the surface opposite to the patient's femur is symmetrically provided with an ankle joint surface 111 and ankle joints located between the two ankle joint surfaces 111 and on both sides of the connection hole 13. The joint surface 112 forms a structure enclosing the femoral end after the osteotomy; on the solid body part 12 of the femoral ankle prosthesis 1, and on the surface opposite to the patient's femur, two femoral articular surfaces 1231 are symmetrically arranged, The articular surfaces 1231 of the two femurs are curved surfaces, which facilitate the rotation of the joints;

参见图4A-图4C,所述人工半月板2放置于股骨踝关节假体1和胫骨托假体3之间,用于传导负荷,其包括一板本体20,该本体20为具有弧形周边的盘状构件,其上表面向外设有一锥状突起21,可与所述连接孔13配合,安装时可插设于该连接孔13内,用于限制膝关节活动度,防止所述股骨踝假体1脱位;所述本体20上表面,设有与股骨踝假体1之股骨关节面1231相配合的胫骨关节面22,分设于突起21两侧,所述本体20下端具有与所述胫骨托假体4相配合的连接部23;Referring to Fig. 4A-Fig. 4C, the artificial meniscus 2 is placed between the femoral ankle prosthesis 1 and the tibial tray prosthesis 3 for conducting load, and it includes a plate body 20, which has a curved periphery The disc-shaped member has a conical protrusion 21 on its upper surface, which can cooperate with the connecting hole 13 and can be inserted into the connecting hole 13 during installation to limit the range of motion of the knee joint and prevent the femoral Dislocation of the ankle prosthesis 1; the upper surface of the body 20 is provided with a tibial articular surface 22 that matches the femoral articular surface 1231 of the femoral ankle prosthesis 1, and is located on both sides of the protrusion 21. The lower end of the body 20 has a The matching connecting portion 23 of the tibial tray prosthesis 4;

参见图5A-图5E,所述胫骨托假体3包括胫骨髓实心主体部分32,所述胫骨髓实心主体部分32上端具有可与所述连接部23配合的定位部321,下端为柱状支承部322,该支承部322外表面覆设有第二多孔固定层31。5A-5E, the tibial tray prosthesis 3 includes a solid main body part 32 of the tibial marrow, the upper end of the solid main body part 32 has a positioning part 321 that can cooperate with the connecting part 23, and the lower end is a columnar supporting part 322 , the outer surface of the support portion 322 is covered with the second porous fixing layer 31 .

上述结构中,在人工假体与骨质接触的固定面上设置多孔固定层,其多孔结构有利于骨组织的长入。这样,可使得多孔固定层与膝关节假体结合强度增大,且多孔固定层较之于现有的涂层模式具有更强的骨诱导能力,更易于骨长入并在内连孔道中延伸交织,使得骨与假体间形成交锁结合,从而实现更为优异的生物学固定效果。本发明人工股骨踝假体和人工胫骨托假体可通过CAD软件进行多孔结构设计,具有多孔结构的人工假体可通过三维快速成型系统实现多孔固定层的制备或多孔固定层与人工假体一体化制备,且上述多孔固定层的设计,适用于所有型号的非骨水泥固定的人工膝关节假体使用,通用性强,可实现工业化生产。In the above structure, a porous fixing layer is provided on the fixing surface of the artificial prosthesis in contact with the bone, and its porous structure is beneficial to the ingrowth of bone tissue. In this way, the bonding strength between the porous fixation layer and the knee joint prosthesis can be increased, and the porous fixation layer has stronger osteoinductive ability compared with the existing coating mode, and it is easier for bone to grow into and extend in the internal connection channel The interweaving makes the bone and the prosthesis form an interlocking combination, so as to achieve a better biological fixation effect. The artificial femoral ankle prosthesis and the artificial tibial tray prosthesis of the present invention can carry out porous structure design through CAD software, and the artificial prosthesis with porous structure can realize the preparation of the porous fixation layer or the porous fixation layer and the artificial prosthesis through the three-dimensional rapid prototyping system Chemically prepared, and the design of the above-mentioned porous fixing layer is suitable for use in all types of non-cemented artificial knee joint prosthesis, has strong versatility, and can realize industrial production.

请再参见图3A-图3E,本发明具体的结构设计中,所述股骨踝假体1可由钴铬钼合金、不锈钢、钛、钛合金、镍钴合金或金属钽材料制成,所述实心主体部分12包括直立设置长包边121、短包边123和连接于长包边121和短包边123之间的底部122,形成外周面为弧面的凹状结构。所述短包边123外周,即与病人的股骨相背的表面,对称设有两所述股骨关节面1231,于所述底部122的中间位置,向上设有一拱形支撑台1221,所述连接孔13垂直穿设于拱形支撑台1221,可为图示所示的矩形孔或多边形孔,其上具有可防止转动的直线边。所述拱形支撑台1221的两侧1222形成与踝间结合面112背面贴合的平面,位于拱形支撑台1221两侧端的底部122上表面1223与踝结合面111背面贴合。这样,第一多孔固定层11覆盖于长包边121、短包边123的内侧面及拱形支撑台1221、两侧1222和上表面1223上,形成包住截骨后的股骨端的结构。由于覆盖于实心主体部分12内表面的第一多孔固定层11是由多个不同层次及不同的表面构成,且根据截骨后的股骨端形状而设计,故而可较好的和人体股骨结合,使第一多孔固定层11与股骨之间的结合面增大,便于骨组织的渗入生长且可避免第一多孔固定层11与股骨端之间的分离。Please refer to Fig. 3A-Fig. 3E again. In the specific structural design of the present invention, the femoral ankle prosthesis 1 can be made of cobalt-chromium-molybdenum alloy, stainless steel, titanium, titanium alloy, nickel-cobalt alloy or metal tantalum material. The main body 12 includes a long wrapping 121 , a short wrapping 123 and a bottom 122 connected between the long wrapping 121 and the short wrapping 123 , forming a concave structure with an arc surface. The outer periphery of the short wrapping 123, that is, the surface opposite to the patient's femur, is symmetrically provided with two described femoral articular surfaces 1231, and an arched support platform 1221 is provided upward at the middle position of the bottom 122, and the connection The hole 13 is perpendicular to the arched support platform 1221, and can be a rectangular hole or a polygonal hole as shown in the figure, with a straight edge that can prevent rotation. The two sides 1222 of the arched support platform 1221 form a plane that is attached to the back of the joint surface 112 between the ankles. In this way, the first porous fixing layer 11 covers the inner surfaces of the long wrapping 121 and the short wrapping 123 , the arch support platform 1221 , both sides 1222 and the upper surface 1223 , forming a structure wrapping the femoral end after osteotomy. Since the first porous fixing layer 11 covering the inner surface of the solid body part 12 is composed of multiple different layers and different surfaces, and is designed according to the shape of the femur end after osteotomy, it can be better combined with the human femur , the bonding surface between the first porous fixing layer 11 and the femur is increased, which facilitates the infiltration and growth of bone tissue and can avoid the separation between the first porous fixing layer 11 and the femur end.

进一步地,所述股骨关节面1231为弧形高抛光面,可减少股骨踝假体1与人工半月板2之间的摩擦系数,同时股骨关节面1231与东方人种膝关节解剖特性相匹配,可实现更大的屈曲度。Further, the femoral articular surface 1231 is an arc-shaped highly polished surface, which can reduce the friction coefficient between the femoral ankle prosthesis 1 and the artificial meniscus 2, and at the same time, the femoral articular surface 1231 matches the anatomical characteristics of the oriental knee joint, Allows for greater flexion.

参见图3B和图3C,两所述股骨关节面1231之间,还凹设有踝间窝1232,便于股骨关节面1231弧形面的形成。Referring to FIG. 3B and FIG. 3C , between the two femoral articular surfaces 1231 , there is also an inter-articular fossa 1232 recessed to facilitate the formation of an arc-shaped surface of the femoral articular surfaces 1231 .

请再参见图3B和图3C,所述股骨踝假体1的实心主体部分12且于连接孔13的两侧,还设有定位翼14,该定位翼14呈向着连接孔13方向内凹的弧形槽,用于与病人的股骨踝外侧结合辅助固定,保证整个膝关节与人体股骨连接的稳定性。Please refer to Fig. 3B and Fig. 3C again, the solid body part 12 of the femoral ankle prosthesis 1 is also provided with positioning wings 14 on both sides of the connection hole 13, and the positioning wings 14 are concave toward the connection hole 13. The arc-shaped groove is used for auxiliary fixation combined with the lateral side of the patient's femoral condyle to ensure the stability of the connection between the entire knee joint and the human femur.

参见图3D,本发明具体的结构设计中,所述实心主体部分12之长包边121外周面中间沿其竖向位置,设有髌骨沟1211,所述髌骨沟1211的两侧分别设有两滑车面1222,构成与髌骨或髌骨假体活动连接的滑车部分,与人体髌骨或髌骨假体接触面的活动连接,便于整个膝关节的转动。Referring to Fig. 3D, in the specific structural design of the present invention, a patella groove 1211 is provided in the middle of the outer peripheral surface of the long wrapping 121 of the solid body part 12 along its vertical position, and two sides of the patella groove 1211 are respectively provided with two sides. The trochlear surface 1222 constitutes the trochlear part that is movably connected with the patella or the patella prosthesis, and is movably connected with the contact surface of the human patella or the patella prosthesis to facilitate the rotation of the entire knee joint.

请参见图4A-图4C,本发明具体的结构设计中,所述人工半月板2由超高分子聚乙烯材料制成。由于膝关节半月板是膝关节的重要组成部分,具有增加关节接触面、润滑关节、承受和传递胫骨和股骨之间的载荷、吸收减震以及保持膝关节的功能性结构等功能。因此,采用金属与高分子聚乙烯组成对关节面,而不是金属与金属的对关节面,这样可增加人体膝关节活动的生物力学相容性。所述人工半月板2突起21的前后端沿其底部分别向胫骨关节面22内凹设有弧形滑移面24,与突起21底部圆滑过渡,一方面便于突起21与股骨踝假体1的连接和安装,另一方面可有利于人工半月板2及胫骨托假体3绕股骨踝假体1的前后转动;所述连接部23包括周边呈弧状的凸台232,该凸台232中间位置向外还设有一定位凸缘231,图示实施例中该定位凸缘231的结构为空心圆套,既便于加工,同时有利于减轻整个构件的重量。Please refer to Fig. 4A-Fig. 4C, in the specific structural design of the present invention, the artificial meniscus 2 is made of ultra-high molecular weight polyethylene material. Since the knee meniscus is an important part of the knee joint, it has the functions of increasing the joint contact surface, lubricating the joint, bearing and transmitting the load between the tibia and femur, absorbing shock and maintaining the functional structure of the knee joint. Therefore, the anti-articular surface composed of metal and high molecular polyethylene, rather than metal and metal, can increase the biomechanical compatibility of human knee joint activities. The front and rear ends of the protrusion 21 of the artificial meniscus 2 are provided with an arc-shaped sliding surface 24, which is recessed toward the tibial articular surface 22 along its bottom, and smoothly transitions with the bottom of the protrusion 21. On the one hand, it is convenient for the protrusion 21 and the femoral ankle prosthesis 1. Connection and installation, on the other hand, can facilitate the forward and backward rotation of the artificial meniscus 2 and the tibial tray prosthesis 3 around the femoral ankle prosthesis 1; the connecting part 23 includes an arc-shaped boss 232 on the periphery, and the middle position of the boss 232 is There is also a positioning flange 231 outward. In the illustrated embodiment, the structure of the positioning flange 231 is a hollow circular sleeve, which is convenient for processing and helps reduce the weight of the entire component.

请参见图5A-图5E,本发明具体的结构设计中,所述胫骨托假体3是由钴铬钼合金、不锈钢、钛、钛合金、镍钴合金或金属钽材料制成,所述胫骨髓实心主体部分32上端的定位部321结构与人工半月板2之连接部23结构适配,包括与所述凸台232结构及形状配合的凹腔3211及与所述定位凸缘231配合的中心槽3213,可使人工半月板2与胫骨托假体3套接。这样,可使人工半月板2与胫骨托假体3通过双重嵌套实现固定,可实现两者之间牢固的定位固定,且这种结构加工简单,制造容易且装配也很方便。所述胫骨髓实心主体部分32下端的柱状支承部322具有向下呈外径渐小的锥台状结构,沿所述锥台大端外周的轴向,向下开设有至少两个对称的条状凹槽3221,所述条状凹槽3221与锥台外周的交界处平滑过渡。图示实施例所示为四个条状弧形凹槽,支承部322横截面显示为从柱体向菱形曲线的平滑过渡。相应地,第二多孔固定层31外周横截面形状与支承部322横截面形状一致。这样,有利于胫骨托假体3与人体腿骨的配合,避免了胫骨托假体3松动,同时可防止配合连接后胫骨托假体3的转动,增加了生物固定的稳定性。Please refer to Fig. 5A-Fig. 5E, in the specific structural design of the present invention, described tibial tray prosthesis 3 is made of cobalt-chromium-molybdenum alloy, stainless steel, titanium, titanium alloy, nickel-cobalt alloy or metallic tantalum material, and described tibial tray The structure of the positioning part 321 at the upper end of the bone marrow solid body part 32 is adapted to the structure of the connecting part 23 of the artificial meniscus 2, including a concave cavity 3211 that matches the structure and shape of the boss 232 and a center that matches the positioning flange 231. The groove 3213 can make the artificial meniscus 2 and the tibial tray prosthesis 3 socketed. In this way, the artificial meniscus 2 and the tibial tray prosthesis 3 can be fixed through double nesting, and the firm positioning and fixing between the two can be realized, and this structure is easy to process, easy to manufacture and convenient to assemble. The columnar supporting part 322 at the lower end of the solid main body part 32 of the tibial marrow has a frustum-like structure with a gradually smaller outer diameter downwards, and at least two symmetrical strips are provided downwards along the axial direction of the outer circumference of the large end of the frustum. The groove 3221, the junction of the strip groove 3221 and the outer periphery of the frustum is smoothly transitioned. The illustrated embodiment shows four strip-shaped arc-shaped grooves, and the cross-section of the support portion 322 shows a smooth transition from a cylinder to a rhombus. Correspondingly, the cross-sectional shape of the outer periphery of the second porous fixed layer 31 is consistent with the cross-sectional shape of the support portion 322 . In this way, it is beneficial to the cooperation of the tibial support prosthesis 3 and the human leg bone, avoiding the loosening of the tibial support prosthesis 3, and simultaneously preventing the rotation of the tibial support prosthesis 3 after being connected, thereby increasing the stability of biological fixation.

进一步地,所述胫骨托假体3的具体结构中,其定位部321与支承部322相对的表面为胫骨结合面3213,所述胫骨结合面3213与东方人种胫骨平台截骨解剖结构相匹配,且可使胫骨托假体3具有与胫骨截骨具有最大的接触面积,降低胫骨骨质受到的压强;于该胫骨结合面3213表面,覆设有与胫骨截骨接触的第三多孔固定层3213,与第一多孔固定层11、第二固定层31的多孔结构一致。由于胫骨结合面3213与人体胫骨表面接触,故此处设计多孔结构,可在第一多孔固定层11、第二多孔固定层31的基础上实现更大面积的与骨组织的接触,更有利于骨组织的长入,生物固定效果更好。Further, in the specific structure of the tibial tray prosthesis 3, the surface of the positioning part 321 opposite to the support part 322 is the tibial joint surface 3213, and the tibial joint surface 3213 matches the anatomical structure of the oriental tibial plateau osteotomy. , and the tibial tray prosthesis 3 has the largest contact area with the tibial osteotomy, reducing the pressure on the tibial bone; on the surface of the tibial joint surface 3213, it is covered with a third porous fixation in contact with the tibial osteotomy The layer 3213 is consistent with the porous structure of the first porous fixed layer 11 and the second fixed layer 31 . Since the tibial joint surface 3213 is in contact with the tibia surface of the human body, a porous structure is designed here, which can realize a larger area of contact with bone tissue on the basis of the first porous fixing layer 11 and the second porous fixing layer 31, and more It is conducive to the ingrowth of bone tissue, and the effect of biological fixation is better.

具体地,本发明所述第一多孔固定层11、所述第二多孔固定层31及第三多孔固定层3213的厚度可为0.2-3mm、孔径0.2-0.8mm、孔隙率30-90%。上述参数可通过CAD软件操作进行结构设计,通过三维快速成型系统制成,其孔径和孔隙率与人松质骨的多孔结构相近,有利于骨组织长入,可实现牢固的生物学固定。Specifically, the thickness of the first porous fixed layer 11, the second porous fixed layer 31 and the third porous fixed layer 3213 of the present invention can be 0.2-3mm, the pore diameter is 0.2-0.8mm, and the porosity is 30- 90%. The above parameters can be designed through CAD software operation, and manufactured by a three-dimensional rapid prototyping system. Its pore size and porosity are similar to the porous structure of human cancellous bone, which is conducive to the growth of bone tissue and can achieve firm biological fixation.

以上所述仅为本发明的较佳实施例而已,并不用以限制本发明,凡在本发明的精神和原则之内所作的任何修改、等同替换和改进等,均应包含在本发明的保护范围之内。The above descriptions are only preferred embodiments of the present invention, and are not intended to limit the present invention. Any modifications, equivalent replacements and improvements made within the spirit and principles of the present invention should be included in the protection of the present invention. within range.

Claims (10)

1. a porous artificial knee joint, comprise femur ankle prosthese, tibia support prosthese and the artificial meniscus between described femur ankle prosthese and described tibia support prosthese, it is characterized in that, described femur ankle prosthese has solid body, the solid body of described femur ankle prosthese offers connecting hole, in the surface that described solid body combines with the femur of patient, be covered with the first porous fixed layer that can be combined fixation with femur sclerotin; On described first porous fixed layer, the surface relative with the femur of patient is arranged with ankle faying face and at faying face between ankle faying face and between the ankle being positioned at described connecting hole both sides described in two, form the structure of the femur end after encasing osteotomy, solid body and the surface opposing with the femur of patient of described femur ankle prosthese are arranged with two femoral joint faces; Described artificial meniscus has one and can to coordinate with described connecting hole and for preventing the projection of described femur ankle prothesis dislocation, the tibial prosthesis face of matching with described femoral joint face, the connecting portion that matches with described tibia support prosthese; Described tibia support prosthese comprises tibia marrow solid body, and described tibia marrow solid body upper end has the location division that can coordinate with described connecting portion, and lower end is support, and this support outer surface is covered with the second porous fixed layer.
2. porous artificial knee joint according to claim 1, is characterized in that: the surface relative with described support, the location division on described tibia support prosthese is tibia faying face, and described tibia faying face surface is covered with the 3rd porous fixed layer.
3. porous artificial knee joint according to claim 1, is characterized in that: described first porous fixed layer and described second porous fixed layer thickness 0.2-3mm, aperture 0.2-0.8mm, porosity 30-90%.
4. porous artificial knee joint according to claim 2, is characterized in that: described 3rd porous fixed layer thickness 0.2-3mm, aperture 0.2-0.8mm, porosity 30-90%.
5. the porous artificial knee joint according to any one of claim 1-4, is characterized in that: the described connecting portion on described artificial meniscus comprises boss and is arranged at the locating flange on this boss; Described location division on described tibia support prosthese comprises the cavity coordinated with described boss and the central channel coordinated with described locating flange.
6. the porous artificial knee joint according to any one of claim 1-4, it is characterized in that: described tibia support prosthese support has gradually little in external diameter frustum structure downwards, and along the axis of the large end periphery of described frustum, offer at least two symmetrical strip grooves downwards, the intersection of described strip groove and frustum periphery seamlessly transits.
7. the porous artificial knee joint according to any one of claim 1-4, is characterized in that: described femoral joint face is high burnishing surface.
8. the porous artificial knee joint according to any one of claim 1-4, it is characterized in that: described femur ankle prosthese and tibia support prosthese are made up of vitallium, rustless steel, titanium, titanium alloy, nickel cobalt (alloy) or metal tantalum material, and described artificial meniscus is made up of ultra high molecular polyethylene material.
9. the porous artificial knee joint according to any one of claim 1-4, is characterized in that: the solid body both sides of described femur ankle prosthese be also provided with for the femur ankle of patient outside combine auxiliary fixing location wing.
10. the porous artificial knee joint according to any one of claim 1-4, it is characterized in that: on described solid body, and with Human Patella or patellar prosthesis contact surface centre position, be provided with patellar groove, the both sides of described patellar groove are respectively equipped with two trochlear surfaces, form the coaster part be flexibly connected with patella or patellar prosthesis.
CN201310578654.8A 2013-11-18 2013-11-18 Porous total knee prosthesis Pending CN104644290A (en)

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CN110772359A (en) * 2019-10-15 2020-02-11 佛山市第一人民医院(中山大学附属佛山医院) Manufacturing method of joint prosthesis and manufacturing method of test mold thereof
CN111281614A (en) * 2020-03-11 2020-06-16 北京市春立正达医疗器械股份有限公司 Knee joint prosthesis
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CN105662657A (en) * 2015-06-02 2016-06-15 北京大学第三医院 Preartis-matching femoral prosthesis for artificial knee joint
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CN107280812A (en) * 2017-07-18 2017-10-24 优适医疗科技(苏州)有限公司 A kind of artificial knee joint prosthesis
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CN110772359B (en) * 2019-10-15 2022-02-01 佛山市第一人民医院(中山大学附属佛山医院) Manufacturing method of joint prosthesis and manufacturing method of test mold thereof
CN111281610A (en) * 2019-12-30 2020-06-16 雅博尼西医疗科技(苏州)有限公司 Connection structure of porous structure and substrate
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CN112618114A (en) * 2020-11-27 2021-04-09 北京市春立正达医疗器械股份有限公司 Tantalum metal trabecular femoral condyle prosthesis and knee joint replacement body
CN114886620A (en) * 2022-04-27 2022-08-12 大连大学附属中山医院 Biological tantalum metal knee joint prosthesis
CN115227458A (en) * 2022-07-11 2022-10-25 广东省科学院新材料研究所 A kind of knee joint prosthesis and preparation method thereof

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