CN117098514A - 骨科植入物及其制造方法 - Google Patents
骨科植入物及其制造方法 Download PDFInfo
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- CN117098514A CN117098514A CN202180090339.3A CN202180090339A CN117098514A CN 117098514 A CN117098514 A CN 117098514A CN 202180090339 A CN202180090339 A CN 202180090339A CN 117098514 A CN117098514 A CN 117098514A
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- Prior art keywords
- orthopedic implant
- digital model
- peak
- porous
- matrix
- Prior art date
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Links
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- 230000000399 orthopedic effect Effects 0.000 title claims abstract description 40
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- 239000000758 substrate Substances 0.000 claims abstract description 10
- 238000010146 3D printing Methods 0.000 claims description 15
- 238000000034 method Methods 0.000 claims description 10
- 210000004394 hip joint Anatomy 0.000 claims description 8
- 229910001069 Ti alloy Inorganic materials 0.000 claims description 6
- 239000006260 foam Substances 0.000 claims description 5
- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 claims description 4
- 210000002310 elbow joint Anatomy 0.000 claims description 4
- 210000000629 knee joint Anatomy 0.000 claims description 4
- 239000010935 stainless steel Substances 0.000 claims description 4
- 229910001220 stainless steel Inorganic materials 0.000 claims description 4
- 229910052719 titanium Inorganic materials 0.000 claims description 4
- 239000010936 titanium Substances 0.000 claims description 4
- 210000003857 wrist joint Anatomy 0.000 claims description 4
- 229910000851 Alloy steel Inorganic materials 0.000 claims description 3
- 229910000684 Cobalt-chrome Inorganic materials 0.000 claims description 3
- 239000000956 alloy Substances 0.000 claims description 3
- 239000010952 cobalt-chrome Substances 0.000 claims description 3
- 230000001788 irregular Effects 0.000 claims description 3
- 210000000988 bone and bone Anatomy 0.000 abstract description 14
- 230000009286 beneficial effect Effects 0.000 abstract description 3
- 230000012010 growth Effects 0.000 abstract description 3
- 230000001737 promoting effect Effects 0.000 abstract description 3
- 239000007787 solid Substances 0.000 description 28
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- 210000000588 acetabulum Anatomy 0.000 description 6
- 230000008468 bone growth Effects 0.000 description 4
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- 230000000694 effects Effects 0.000 description 1
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- 238000002513 implantation Methods 0.000 description 1
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- 210000003141 lower extremity Anatomy 0.000 description 1
- 230000013011 mating Effects 0.000 description 1
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- 210000001364 upper extremity Anatomy 0.000 description 1
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Landscapes
- Health & Medical Sciences (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Engineering & Computer Science (AREA)
- Vascular Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Cardiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Transplantation (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Manufacturing & Machinery (AREA)
- Physics & Mathematics (AREA)
- Geometry (AREA)
- Physical Education & Sports Medicine (AREA)
- Prostheses (AREA)
Abstract
本申请公开了骨科植入物及其制造方法。该骨科植入物具有多孔结构体,多孔结构体包括基体和多个尖峰。基体为多孔结构。多个尖峰凸出并分布于基体的外表面。本申请的骨科植入物更有利于促进人体骨骼的生长。
Description
技术领域
本发明涉及医疗器械领域,具体涉及骨科植入物。
背景技术
人工髋关节通常包括固定于人体上肢的人工髋臼杯,安装于人工髋臼杯内的半球形塑料件,通过固件件固定于人体下肢的球头。现有的人工髋臼杯通常包括实心金属座体和从实心金属座体延伸出的实心金属穹顶。现有的一些人工髋臼杯的穹顶外层还包覆有一层多孔结构层。
本申请的发明人发现,现有的人工髋臼杯,由于实心金属部分的厚度太厚,在受力时,大部分力会被实心金属部分所承受而难以传递到人体骨头,导致人体骨头受到的力刺激很小,甚至没有力刺激。而当人体骨头没有收到力刺激或者受到的力刺激很小,则骨头会停止生长。因此,需要开发一种更好的人工髋臼杯。
本申请的发明人还发现,现有的骨科植入物中,与人体骨头接触的部分尚难以很好与人体骨头配合,不能很好地促进骨骼生长。因此,需要开发更好的骨科植入物结构。
发明内容
本发明的目的是提供一种能够促进骨骼生长的骨科植入物。
为实现上述目的,本发明提供了一种骨科植入物,所述骨科植入物具有多孔结构体,所述多孔结构体包括:
基体,所述基体为多孔结构;
多个尖峰,多个所述尖峰凸出并分布于所述基体的外表面。
一实施例中,所述尖峰一体形成于所述基体的外表面。
一实施例中,所述基体为网状多孔结构。
一实施例中,相邻两个所述尖峰之间的距离范围为300μm~1000μm。
一实施例中,所述尖峰与所述基体的外表面之间的角度范围为65°~110°。
一实施例中,所述基体的表面为弧面。
一实施例中,所述尖峰为锥体、圆柱体或者不规则凸起。
一实施例中,所述多孔结构体通过3D打印制成。
一实施例中,所述多孔结构体由钛合金、纯钛、鈷铬合金、或不锈钢制成。
一实施例中,所述骨科植入物为人工膝关节、人工髋关节、腕关节、肘关节、指关节、或髁关节。
根据本发明的另一发明,还提供了一种骨科植入物的制造方法,所述制造方法包括以下步骤:
S1、建立多孔基体数字模型;
S2、将一尖峰数字模型添加至所述多孔基体数字模型,使得该尖峰数字模型和所述多孔基体数字模型重叠;
S3、对该尖峰数字模型进行阵列化而获得多个尖峰数字模型;
S4、将阵列化获得的多个所述尖峰数字模型与所述多孔基体数字模型融合,然后进行3D打印而得到所述骨科植入物。
一实施例中,所述制造方法进一步包括以下步骤:在进行3D打印之前,将阵列化获得的多个所述尖峰数字模型与所述多孔基体数字模型融合之后得到的数字模型与一多孔泡沫数字模型进一步融合。
一实施例中,将阵列化获得的多个所述尖峰数字模型与所述多孔基体数字模型融合通过布尔运算来完成。
根据本发明的又一发明,还提供了一种骨科植入物的制造方法,所述制造方法包括以下步骤:
S1、建立多孔基体数字模型;
S2、在所述多孔基体数字模型的外表面切槽来获得尖峰,并通过调节槽间距和槽的深度来控制所述尖峰的高度;
S3、进行3D打印而得到所述骨科植入物。
本申请的骨科植入物具有多孔结构体,并在多孔结构体的外表面分布有尖峰结构,更有利于促进人体骨骼的生长。
附图说明
图1是根据本发明的一实施例的人工髋臼杯的立体图。
图2是图1的人工髋臼杯部分切除后的俯视图。
图3是根据本发明的另一实施例的人工髋臼杯的分解立体图。(
图4是图3的人工髋臼杯的截面图。
图5是图4的A部分的放大图。
图6是根据本发明的一实施例的骨科植入物的制造方法的流程图。
图7~10是根据6的制造方法制成的骨科植入物的多孔结构表面的多种不同尖峰结构的显微镜图。
具体实施方式
以下将结合附图对本发明的各实施例进行详细说明,以便更清楚理解本发明的目的、特点和优点。应理解的是,附图所示的实施例并不是对本发明范围的限制,而只是为了说明本发明技术方案的实质精神。
在下文的描述中,出于说明各种公开的实施例的目的阐述了某些具体细节以提供对各种公开实施例的透彻理解。但是,相关领域技术人员将认识到可在无这些具体细节中的一个或多个细节的情况来实践实施例。在其它情形下,与本申请相关联的熟知的装置、结构和技术可能并未详细地示出或描述从而避免不必要地混淆实施例的描述。
除非语境有其它需要,在整个说明书和权利要求中,词语“包括”和其变型,诸如“包含”和“具有”应被理解为开放的、包含的含义,即应解释为“包括,但不限于”。
在整个说明书中对“一个实施例”或“一实施例”的提及表示结合实施例所描述的特定特点、结构或特征包括于至少一个实施例中。因此,在整个说明书的各个位置“在一个实施例中”或“在一实施例”中的出现无需全都指相同实施例。另外,特定特点、结构或特征可在一个或多个实施例中以任何方式组合。
如该说明书和所附权利要求中所用的单数形式“一”和“所述”包括复数指代物,除非文中清楚地另外规定。应当指出的是术语“或”通常以其包括“和/或”的含义使用,除非文中清楚地另外规定。
在以下描述中,为了清楚展示本发明的结构及工作方式,将借助诸多方向性词语进行描述,但是应当将“前”、“后”、“左”、“右”、“外”、“内”、“向外”、“向内”、“上”、“下”等词语理解为方便用语,而不应当理解为限定性词语。
本申请涉及骨科植入物及其制造方法,尤其是人工髋关节及其制造方法。人工髋关节通常包括人工髋臼杯、衬垫和球头。人工髋臼杯用于植入骨盆腔的髋臼内,通常是用钛合金或钴铬钼合金制造。衬垫做为人工髋关节的介面,通常用聚乙烯、陶瓷、金属等制成。球头通过固件件接合在股骨柄上并与衬垫配合而形成关节介面,其一般用陶瓷或金属材料制成。本申请主要涉及人工髋臼杯,该人工髋臼杯大量采用了多孔结构,尤其是在人工髋臼杯的穹顶部分采用大量的多孔结构,使得其整体重量大大降低,生产成本更低,并且更有利于人体骨头的生长。
图1-2示出根据本发明的一实施例的人工髋臼杯100的结构图。如图1-2所示,人工髋臼杯100具有环形座体101和从环形座体一体延伸出的穹顶102。环形座体101的内环直径和外环直径可以根据不同的髋臼杯规格来设定,以匹配不同人体的骨盆腔的髋臼。环形座体101具有预定的高度,在满足强度的前提下,该高度越低越好,以降低重量和生产成本。本申请中,环形座体101的高度H可以为10mm到40mm。较佳地,环形座体101的高度H可以为19mm到38mm。
环形座体101的内侧边缘设有朝向穹顶内侧开口的相互间隔开的多个开口槽1011。开口槽1011的形状与对应的人工髋关节的衬垫的外周边缘的凸起形状相匹配,用于安装衬垫。本实施例,开口槽1011为三角形。在环形座体101的外侧边缘还设有沿环形座体径向从该外侧边缘一体延伸出的凸片12,供安装时夹持。
穹顶102从环形座体101的上表面一体延伸出并呈半球状。穹顶102具有内层1021和覆盖于内层1021的外层1022。内层1021的厚度小于外层1022厚度。穹顶102的内层1021包含实心层1023和多孔结构层1024。实心层1023具有从环形座体101的上表面一体延伸出的实心筒状部1025和从实心筒状部1025沿经度方向方向延伸的多根实心梁1026。多根实心梁1026相互间隔开。相邻两根实心梁1026之间填充有多孔结构1027。穹顶102的内层1021的多孔层部分,即多孔结构1027相对于实心梁1026下凹。由此,可节约材料。在实心梁1026处设有一个或多个安装孔1028,用于将该人工髋臼杯固定至人体中。穹顶102的顶部还设置有装配孔1029,用于在将该人工髋臼杯组装至人体时,与相应的器械工具配合。在形成安装孔1028和装配孔1029的位置处的实心部分可以做得相比于其他位置的实心部分更厚,以使得安装孔1028和装配孔1029具有足够的强度。可以理解的是,上述的实心梁也可以直接从环形座体1的顶面延伸至穹顶的顶部,即可以不设置实心筒状部1025。由此,可进一步减少材料的使用量。
穹顶102的外层1022一体地覆盖内层1021。外层1022的至少一部分为多孔结构层。本实施例中,除了安装孔和装配孔之外,外层1022的其余部分均为多孔结构层。此种情况,可以视作整个外层为多孔结构层。内层的厚度小于外的厚度。内层的厚度T1可以为外层的厚度T2的1/50~1/2。较佳地,内层的厚度为1/20~1/5。本申请中,由于实心层的厚度小于多孔结构层的厚度,实心金属部分的厚度很薄,可薄至0.05mm,因此,髋臼在受力时,受到实心金属部分的阻挡较小,大部分力可传递至人体骨头,即更薄的实心金属部分可以减少对髋臼骨的应力屏蔽,由此刺激人体骨头生长,进而能够使得人工髋臼更好地嵌合于人体。
进一步地,相比于现有技术中实心层厚度远大于多孔层厚度,本申请的髋臼杯的重量可以大大降低,由此可大大降低生产成本。下表1为相同规格,不同结构的钛合金制成的人工髋臼杯的重量比对表格,可见,本申请的人工髋臼杯的总重量仅为现有技术的人工髋臼杯的总重量的约2/3。
表1
穹顶102的外层1022的外表面为弧面,其具体形状与人体的髋臼相匹配。较佳地,穹顶102的外层1022的外表面为圆弧面。穹顶的多孔结构外层的外表面可分布有尖峰结构1029。较佳地,尖峰通过3D打印的方式一体形成于穹顶的外层的外表面。相邻两个尖峰之间的距离D范围可为300μm~1000μm。较佳地,相邻两个尖峰之间的距离D范围可为400μm~800μm。尖峰与穹顶的外层的外表面之间的角度α范围为65°~110°,即尖峰的中心轴线与穹顶的外层在尖峰所在位置处的切线之间的角度范围65°~110°。通过在穹顶的外层外表面设置尖峰,可以大大提高人工髋臼杯的摩擦系数。
尖峰的产生方法可通过软件,在数字多孔结构外层外表面切槽,通过调节槽间距和槽的深度来控制尖峰的高度。对多孔球面,切槽沿经度和纬度方向,调整尖峰间距;深度沿半径方向,控制尖峰的高度。对立方块的多孔平面,切槽沿表面水平相互垂直的方向,调整尖峰间距;深度向下方向,控制尖峰的高度。立方块样品具有平整表面,磨擦系数比球面容易测定。下表2为5种不同立方块样品所测得的静摩擦系数和动摩擦系数,其中编号为P-00250是多孔结构外层外表面设置有尖峰的样品,尖峰高度0.5mm,尖峰间隔0.5mm。其中编号为P-00248样品尖峰高度0.25mm,尖峰间隔0mm。编号为P-00249样品尖峰高度0.5mm,尖峰间隔0mm。编号为P-00251样品尖峰高度0.5mm,尖峰间隔0.7mm.,编号为P-00250EDM side用电火花切割多孔表面,表面无尖峰,即样品尖峰高度0mm,尖峰间隔0mm。
表2
从表中可以看出,设置有尖峰结构的多孔结构表面的静摩擦系数和动摩擦系数都远大于不设置尖峰结构的多孔结构表面的静摩擦系数和动摩擦系数。由此,更有利于该植入物与人体骨头的相互契合配合,产生钉扎作用。应理解,图1-2所示的实施例中,也可以不在外层的多孔结构上设置尖峰结构。
图3示出本发明的第二实施例的人工髋臼杯200的分解立体图。本实施例与图1所示的实施例不同之处主要在于本实施例的人工髋臼杯200的穹顶的内层全部为实心层。如图2所示,人工髋臼杯200具有环形座体201和穹顶202。环形座体201的结构可以与图1所示实施例相同或基本相同,在此不再详述。穹顶202具有内层2021和外层2022。本实施例中,人工髋臼杯200的穹顶202的内层2021的内表面为实心层,且具有光滑的表面,即没有突出的梁。应理解,内层2021的内表面也可以是设置一些凸出的梁。类似地,人工髋臼杯200的穹顶202内层的外表面可以是设有突出的梁2023,如图2所示。与图1所示实施例相同,本实施例的人工髋臼杯的外层2022是多孔结构层,其一体地覆盖内层2021。
图3所示类型的人工髋臼杯200一般适用于超大髋杯,例如60mm、62mm、64mm、66mm、67mm、70mm、72mm、74mm、76mm、78mm、80mm等规格的人工髋臼杯。采用这种结构的超大人工髋臼杯将具有高的刚性和低的重量,同时可以使得UHMWPE内衬将变得更薄。
人工髋臼杯的穹顶202的外层2022的外表面分布有尖峰结构2029,如图4-5所示。尖峰2029通过3D打印的方式一体形成于穹顶的外层的外表面。相邻两个尖峰之间的距离D范围可为300μm~1000μm。较佳地,相邻两个尖峰之间的距离D范围可为400μm~800μm。尖峰与穹顶的外层的外表面之间的角度α范围为65°~110°,即尖峰的中心轴线与穹顶的外层在尖峰所在位置处的切线之间的角度范围65°~110°。通过在穹顶的外层外表面设置尖峰,可以大大提高人工髋臼杯的摩擦系数。应理解,图3-5所示的实施例中,也可以不在外层的多孔结构上设置尖峰结构。
上述的人工髋臼杯可以由钛合金、纯钛、鈷铬合金、或不锈钢制成。较佳地,人工髋臼杯可通过3D打印制成。具体地,如图5所示,在制造时,先建立一人工髋臼杯数字模型,该人工髋臼杯数字模型具有与待制成的人工髋臼杯一样的结构。可以采用本领域已知的或待开发的任何适合的方式来建立上述人工髋臼杯数字模型。然后,对该人工髋臼杯数字模型进行3D打印,由此获得人工髋臼杯。
发明人进一步发现,上述的穹顶外层的结构,即在多孔基体上分布有尖峰的结构,也可以应用于其他骨科植入物,例如人工膝关节,腕关节,肘关节,指关节,髁关节。具体地,本申请还开发了一种骨科植入物,该骨科植入物具有多孔结构体,多孔结构体具有基体和多个尖峰(spike)。多个尖峰凸出并分布于基体的外表面。基体为多孔结构,其外表面可以为平面、弧面或任何合适的形状。较佳地,基体为网状多孔结构。网状多孔结构可以通过扫描网状人造泡沫或者人体骨骼网状结构等来获得。尖峰可以为锥体、圆柱体、或不规则凸起等。相邻两个尖峰之间的距离D范围为300μm~1000μm。尖峰与基体的外表面之间的角度范围为65°~110°。
多孔结构体由钛合金、纯钛、鈷铬合金或不锈钢等制成。多孔结构体通过3D打印制成。本申请的一实施例中,该骨科植入物的制造方法可包括以下步骤:
S1建立多孔基体数字模型;
S2将一个尖峰数字模型添加至基体数字模型,使得该尖峰数字模型和基体数字模型重叠;
S3对该尖峰数字模型进行阵列化而获得多个尖峰数字模型;
S4将阵列化获得的多个尖峰数字模型与基体数字模型融合,然后进行3D打印而得到骨科植入物。
上述步骤S1中,可以通过如下子步骤来实现:
S11对网状人造泡沫进行扫描并将扫描结果存储成数字多孔模型;
S12对所述数字多孔模型进行编辑;
S13对所述数字多孔模型进行装配而形成数字多孔块;
S14对所述数字多孔块进行编辑而获得多孔基体数字模型。
进一步地,制造方法进一步包括以下步骤:在进行3D打印之前,将阵列化获得的多个尖峰数字模型与基体数字模型融合之后得到的数字模型与一多孔泡沫数字模型进一步融合(merge)。较佳地,将阵列化获得的多个尖峰数字模型与基体数字模型融合通过布尔运算(boolean)来完成。
上述骨科植入物的制造方法还可以包括建立一实心基体数字模型,将阵列化获得的多个尖峰数字模型与基体数字模型融合所得到的第一数字模型,进一步与该实心基体数字模型进行融合而得到第二数字模型。接下来,对该第二数字模型进行编辑,而获得具有所需骨科植入物形状的第三数字模型。最后,对上述第三数字模型进行编辑,而获得所需的骨科植入物。该骨科植入物可以是人工膝关节、人工髋关节、腕关节、肘关节、指关节、髁关节等。
通过上述方法制得的骨科植入物能够很好地配合人体骨头,促进骨头生长,并且生产成本较低。
以上已详细描述了本发明的较佳实施例,但应理解到,若需要,能修改实施例的方面来采用各种专利、申请和出版物的方面、特征和构思来提供另外的实施例。
考虑到上文的详细描述,能对实施例做出这些和其它变化。一般而言,在权利要求中,所用的术语不应被认为限制在说明书和权利要求中公开的具体实施例,而是应被理解为包括所有可能的实施例连同这些权利要求所享有的全部等同范围。
Claims (14)
1.一种骨科植入物,所述骨科植入物具有多孔结构体,其特征在于,所述多孔结构体包括:
基体,所述基体为多孔结构;
多个尖峰,多个所述尖峰凸出并分布于所述基体的外表面。
2.根据权利要求1所述的骨科植入物,其特征在于,所述尖峰一体形成于所述基体的外表面。
3.根据权利要求1所述的骨科植入物,其特征在于,所述基体为网状多孔结构。
4.根据权利要求1所述的骨科植入物,其特征在于,相邻两个所述尖峰之间的距离范围为300μm~1000μm。
5.根据权利要求1所述的骨科植入物,其特征在于,所述尖峰与所述基体的外表面之间的角度范围为65°~110°。
6.根据权利要求1所述的骨科植入物,其特征在于,所述基体的表面为弧面。
7.根据权利要求1所述的骨科植入物,其特征在于,所述尖峰为锥体、圆柱体或者不规则凸起。
8.根据权利要求1所述的骨科植入物,其特征在于,所述多孔结构体通过3D打印制成。
9.根据权利要求1所述的骨科植入物,其特征在于,所述多孔结构体由钛合金、纯钛、鈷铬合金、或不锈钢制成。
10.根据权利要求1所述的骨科植入物,其特征在于,所述骨科植入物为人工膝关节、人工髋关节、腕关节、肘关节、指关节、或髁关节。
11.一种骨科植入物的制造方法,其特征在于,所述制造方法包括以下步骤:
S1、建立多孔基体数字模型;
S2、将一尖峰数字模型添加至所述多孔基体数字模型,使得该尖峰数字模型和所述多孔基体数字模型重叠;
S3、对该尖峰数字模型进行阵列化而获得多个尖峰数字模型;
S4、将阵列化获得的多个所述尖峰数字模型与所述多孔基体数字模型融合,然后进行3D打印而得到所述骨科植入物。
12.根据权利要求11所述的制造方法,其特征在于,所述制造方法进一步包括以下步骤:在进行3D打印之前,将阵列化获得的多个所述尖峰数字模型与所述多孔基体数字模型融合之后得到的数字模型与一多孔泡沫数字模型进一步融合。
13.根据权利要求11所述的制造方法,其特征在于,将阵列化获得的多个所述尖峰数字模型与所述多孔基体数字模型融合通过布尔运算来完成。
14.一种骨科植入物的制造方法,其特征在于,所述制造方法包括以下步骤:
S1、建立多孔基体数字模型;
S2、在所述多孔基体数字模型的外表面切槽来获得尖峰,并通过调节槽间距和槽的深度来控制所述尖峰的高度;
S3、进行3D打印而得到所述骨科植入物。
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US5019083A (en) * | 1989-01-31 | 1991-05-28 | Advanced Osseous Technologies, Inc. | Implanting and removal of orthopedic prostheses |
FR2755603B1 (fr) * | 1996-11-12 | 1999-02-26 | Jacques Preaut | Ensemble d'ancillaires pour la pose de cotyles de protheses de hanche, et ensemble prothetique de cotyle pret a etre pose |
WO2007054553A1 (de) * | 2005-11-09 | 2007-05-18 | Zimmer Gmbh | Implantat |
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US10765530B2 (en) * | 2012-06-21 | 2020-09-08 | Renovis Surgical Technologies, Inc. | Surgical implant devices incorporating porous surfaces |
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CN204049935U (zh) * | 2014-07-16 | 2014-12-31 | 凯德信诚(北京)技术开发有限公司 | 带有刺入式固定结构的髋臼杯 |
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