CN101277651B - 移植器 - Google Patents
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- CN101277651B CN101277651B CN200680036588XA CN200680036588A CN101277651B CN 101277651 B CN101277651 B CN 101277651B CN 200680036588X A CN200680036588X A CN 200680036588XA CN 200680036588 A CN200680036588 A CN 200680036588A CN 101277651 B CN101277651 B CN 101277651B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
- A61B17/17—Guides or aligning means for drills, mills, pins or wires
- A61B17/1739—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body
- A61B17/1742—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body for the hip
- A61B17/175—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body for the hip for preparing the femur for hip prosthesis insertion
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/32—Joints for the hip
- A61F2/36—Femoral heads ; Femoral endoprostheses
- A61F2/3601—Femoral heads ; Femoral endoprostheses for replacing only the epiphyseal or metaphyseal parts of the femur, e.g. endoprosthetic femoral heads or necks directly fixed to the natural femur by internal fixation devices
- A61F2/3603—Femoral heads ; Femoral endoprostheses for replacing only the epiphyseal or metaphyseal parts of the femur, e.g. endoprosthetic femoral heads or necks directly fixed to the natural femur by internal fixation devices implanted without ablation of the whole natural femoral head
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30604—Special structural features of bone or joint prostheses not otherwise provided for modular
- A61F2002/30616—Sets comprising a plurality of prosthetic parts of different sizes or orientations
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- A61F—FILTERS 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
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
- A61F2002/30878—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
- A61F2002/30879—Ribs
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2/30—Joints
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
- A61F2002/30878—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
- A61F2002/30884—Fins or wings, e.g. longitudinal wings for preventing rotation within the bone cavity
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
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- A61F2002/30878—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
- A61F2002/30891—Plurality of protrusions
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
- A61F2002/30878—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
- A61F2002/30891—Plurality of protrusions
- A61F2002/30892—Plurality of protrusions parallel
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
- A61F2002/30878—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
- A61F2002/30891—Plurality of protrusions
- A61F2002/30896—Plurality of protrusions perpendicular with respect to each other
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- A—HUMAN NECESSITIES
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- A61F—FILTERS 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
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
- A61F2002/30904—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves serrated profile, i.e. saw-toothed
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
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- A61F2002/30906—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth shot- sand- or grit-blasted
Abstract
本发明涉及一种帽状移植器,用于移植在预制的股骨头残端上。移植器为球部分(11)的形式,包括平坦基表面(13)和相对于基表面(13)垂直设置的极轴(15)。根据本发明,腔(17)设置在球部分(11)中,并从基表面(13)突出,所述腔(17)旋转对称,并包括空腔轴(19),空腔轴(19)设置在相对于极轴(15)的非零的角度(α)之下。
Description
技术领域
本发明涉及一种制造成帽状用于移植在预制残端上的移植器。
背景技术
当使用这类制成帽状的移植器时,病人的自然股骨头可在很大程度上被保留。股骨头在操作中仅在其表面上加工,从而允许放置制成帽状的移植器。这种外科手术也已知为“重修表面(resurfacing)”。
用于股骨头的重修表面移植器由EP1407728可知,其设置有用于固定的延伸进入股骨颈中的栓(spigot)。US2003/0163202公开了一种移植器,其具有锥形内接触表面,用于紧固至预制为锥形残端(stump)形式的股骨头。
在此,对先前所述类型的制成帽状的移植器而言,现在提出,除了多种其他有利性能外,以良好的方式对自然股骨头的接合表面的复制部分,可被移植而具有较低的骨材料损耗,并确保良好的主固定(primary anchorage)以及通过粘结(cemented)或非粘结(uncemented)移植的长期的牢固可靠的就位。更具体地,例如,应该可以通过由股骨盖的外表面形成的人工接合表面复制关于股骨头颈轴基本上对称的自然接合表面的几何形状,并同时可确保移植器可靠固定在股骨头上。必须注意的是,在这种情况下,引入股骨头的力的主要施加方向大致沿着从股骨头引向股骨远端的线,或者,甚至更明显地偏离股骨颈轴。根据进一步的方面,移植器应设置为使其能够可靠地固定在预制的股骨头残端上。应进一步提出的是,一种用于移植制成帽状的移植器的方法。还应提出的是,一种用于制造所述制成帽状的移植器的方法。应进一步提出的是,一种用于制造制成帽状的移植器的器具。
除了其他有利性能外,在权利要求中所描述的主题也可满足这些要求。各种性能,例如,由外科医生的简单处理,具有最小切口或具有最小骨组织损耗的移植能力,和在软部分上的轻缓移植,被认为无需说明并被视为可以满足。
发明内容
所述的移植器具有球部分的形状,该球部分具有平坦的基表面和设置为垂直于基表面的极轴。旋转对称的空腔设置在球部分中并始于基表面,所述空腔包括至少部分地设置在基表面中的开口。空腔具有设置为与极轴成非零角度的空腔轴。这可使移植器能够设置在预制残端上,使得移植器的极轴与股骨头的颈轴一致。同时,可进行移植器的紧固,使得移植器空腔的空腔轴与股骨头的主应变方向至少基本上一致。
在一个实施例中,空腔轴与极轴相交,特别是在球部分的球中心处相交。极轴和空腔轴相互具有一定角度,该角度例如在15°至50°的范围内,特别是在从15°至35°的范围内。这例如包括主应变方向的倾斜角相对于颈轴的倾斜的范围。球部分具有例如在从38mm至60mm范围内的球直径,和从基表面沿极轴方向测量至极点的为球直径的60%至80%的高度。所述的直径范围对于其中保留股骨颈以确保可动性的假肢具有代表性,并且例如在自然股骨头的直径范围内选择。采用这些直径时,例如,使用由金属制成的股骨部件,例如在EP892627中所述的部件,并且还例如结合金属配合运行表面使用,该金属配合运行表面同样由EP892627可知;并且这些专利文件描述了本描述的整体部件。沿极轴测量的盖高度确保了足够大的角度范围,其中,股骨盖使得有效接合表面可用。
在移植器的一个实施例中,所述空腔具有内表面,所述内表面包括凹入球部分表面的凹入部,并且所述内表面的至少一个周部包括凹入球部分的球表面区域的凹入部。特别地,所述内表面的第一周部可凹入球部分的球表面区域,并且,所述内表面的第二周部可凹入基平面。因此,移植器可具有盖开口,盖开口被移植器的边缘限定,所述边缘仅部分地设置在基表面的平面中,即,并未在全部周界上。所述边缘的第一区域可设置在基表面的平面中,并且,所述边缘的第二区域可设置在垂直于空腔轴定向的入口平面中。因而这意味着,移植器的开口不是平坦的,而是被分成垂直于极轴和垂直于空腔轴的两部分表面。
在进一步的实施例中,所述空腔具有锥形残端的形状,这种形状在朝向移植器内部的方向上沿空腔轴渐缩。由于锥形残端的形状,因而在预制残端处的骨组织的刺激可增加,以相应地抵制骨材料的退化,从而刺激骨材料在移植器上的生长,由于所述锥形设计,使得压缩应变在残端与移植器内表面之间的界面的所有区域中存在。进一步地,锥形表面可被简单地制造。锥形残端具有完全的锥形开度角,所述锥形开度角例如为,10°至65°,特别是16°至50°。
在移植器的一个实施例中,固定装置设置在空腔的内部,用于在残端上固定移植器,固定装置设置在移植器的限定所述空腔的内表面上。固定装置,例如,用于在骨上对移植器进行进一步改进的主固定,并且还可用作为防止移植器在骨残端上旋转的安全结构,不过,不具有固定装置的实施例可允许具有较低的骨材料损耗的侵入较浅(less invasive)的移植。通常,所描述的移植器被设置为用于无粘结移植,然而,使用骨粘结的移植,通常自然也是可以的。在一个实施例中,固定装置被设置为关于空腔轴对称分布。在空腔的边缘处的固定装置的结构中,在预制的股骨头残端的中心的骨组织保持未受损坏。在移植器的一个示例性实施例中,固定装置包括钩状结构,此钩状结构设置在空腔的周界处并背离空腔的开口而弯曲进入移植器的内部。钩状结构例如通过多个固定齿而形成,所述固定齿的高度在从几十分之一毫米至数毫米的范围内,例如,在从几十分之一毫米至大约1mm的范围内,例如,在从0.5mm至1.5mm的范围内。这些结构,例如围绕空腔轴同心设置。在移植器的进一步的实施例中,固定装置包括平行于空腔轴定向并特别是作为主固定的多个固定肋、固定翼和/或固定销。在固定翼的情况下,相应切割可使用相应的锯片通过锯入或切入股骨头而以简单的方式形成在所述翼中。对于各固定元件的数量,在一方面的骨材料损耗与另一方面的最佳可能固定之间可进行权衡。
为了促进骨材料向内生长进入移植器中,空腔可被内表面限制,所述内表面至少部分地被粗喷(rough blast)和/或具有微结构。移植器的围绕空腔的内表面具有例如钛等离子体涂层。内表面还可具有多孔结构,此多孔结构的表面被金属、特别是钽围绕。这种表面是已知的,例如,在移植器制造商ZIMMER的商标名称“Trabecular Metal”下的表面。
根据权利要求1的移植器的上述不同实施例和其中实现的特征可自然地相互组合。
根据所述用于移植器的移植方法,制成帽状的移植器被选择为包括具有空腔轴的空腔。股骨头以一定方式被切除以获得呈现出与移植器的空腔配合的形状并相对于移植轴旋转对称的预制残端,实际上使得移植轴相对于股骨颈轴至少沿额状面倾斜,而且如下文所述,至多还沿矢状面倾斜。沿额状面的倾斜度,例如在15°至50°的范围内,特别是在15°至35°的范围内,并且,通常被设定为使得移植轴与股骨头的主应变方向一致。可以特别地选择上述类型的移植器。
在用于移植器的移植方法的实施例中,第一钻孔线沿股骨颈轴插入股骨头,对准器具被放置在第一钻孔线上,第二钻孔线沿相对于股骨颈轴倾斜的移植轴插入股骨头,并且,在切除股骨头之前移除对准器具和第一钻孔线,上述步骤特别是以这种顺序实施。有助于使得第一钻孔线可在股骨头上居中和/或可与股骨颈形成对准的器具和方法是已知的,例如,来自ZEMMER的用于DUROM髋盖移植的居中器具。对准器具包括指示或引导装置,其用于限定移植轴相对于颈轴的倾斜度,并由此限定移植轴。
可替代地,利用合适的辅助装置和/或方法,第二钻孔线也可不借助于第一钻孔线而直接移植。例如,第二钻孔线在加工股骨头时可用作引导工具和/或在将制成帽状的移植器放置在预制残端上之前移除。
在一个实施例中,用于移植一移植器、特别是上述类型的移植器的方法,包括:移植所述移植器,使得在将制成帽状的移植器放置在预制残端上之后空腔轴与移植轴相符合。用于移植器的移植方法可另外包括:紧固移植器以防止空腔轴相对于移植轴倾斜。紧固可包括引导移植器,所述引导沿移植轴方向对准。一个实施例包括加工股骨头,使得移植轴相对于股骨颈轴的倾斜度对应于移植器的极轴与空腔轴之间的角度。进一步地,在一个实施例中,移植器被放置为使得移植器的极轴与股骨颈轴一致。用于移植器的移植方法的进一步的示例性实施例包括:加工股骨头,使得移植轴相对于股骨颈轴沿额状面和沿矢状面倾斜,即具有所称的前倾角。
根据涉及移植方法的独立权利要求的移植方法的上述不同实施例或在其中所实现的特征可自然地相互组合。
在所述的用于制造适于预制的股骨头残端的制成帽状的移植器、特别是上述移植器的方法中,制造一种球部分,所述球部分具有平坦基表面和垂直于基表面设置的极轴,并且,形成旋转对称的空腔,所述空腔具有在完全球部分中的空腔轴并始于基表面,使得空腔轴被设置为相对于极轴而成非零的角度。在这一方面,例如,可首先制造具有平坦基表面的球部分,并且可在此后引入空腔中,或者,首先在球体或球部分中建立空腔,并且,平坦表面通过合适方法制造并垂直于极轴设置,极轴与空腔轴具有非零的角度。
在所述的用于制造适于预制的股骨头残端的制成帽状的移植器、特别是上述移植器的进一步的方法中,在空腔的内表面形成槽,例如通过车削加工形成槽,从而在内表面处获得采用围绕空腔轴同心设置的同心环形式的凸起部分。最后,环形凸起部分通过冲压处理形成切口,以形成总是基于同心环的多个固定齿。在这一方面,空腔在其制造中形成相对于所希望的最后空腔尺度的尺寸较小的直径。在此方法的实施例中,当沿空腔轴的方向施加指向空腔中的力时产生切口。在邻近于切口设置的拐角区域中的其余凸起部分,因此塑性变形而使其朝向空腔中。因此形成用于固定移植器的钩结构。用于产生切口的器具,特别是冲压器具,可特别地沿空腔轴的方向引入空腔中,并在沿空腔轴的方向施加指向空腔中的力时压靠凸起部分,从而产生切口。用于实施这种方法的器具包括轴部和头部。所述器具可夹持在轴部处。连接至轴部的所述头部包括用于产生切口的至少两个冲压边沿。冲压边沿在侧视图中具有一定外形,所述外形在移植器的平行于空腔轴的部分中为与空腔的内表面配合的形状。
所述用于制造移植器内部中的固定元件的方法当然并不限于帽形元件,而是可用于具有内腔的其他移植器中,所述内腔被设计用于接触骨,并且,原发性固定和向内生长在内腔处进行。
加工移植器的球接合表面,例如利用EP 1340477所述的方法进行。
用于移植器的移植方法包括:选择制成帽形的移植器,所述移植器包括具有空腔轴的空腔;切除股骨头以获得预制残端,所述预制残端呈现与移植器空腔配合的形状并关于移植轴旋转对称;并且,加工股骨头,使得移植轴相对于股骨颈轴至少沿额状面倾斜。
进一步的方法进一步包括:将第一钻孔线沿股骨颈轴插入股骨头中;将对准器具放置在第一钻孔线上,该对准器具包括指示或量规装置,用于限定移植轴相对于股骨颈轴的倾斜度,并由此限定移植轴;将第二钻孔线沿相对于股骨颈轴倾斜的轴线插入股骨头中;并且,在切除股骨头之前,移除对准器具和第一钻孔线。
对此,在所述方法的一个实施例中,合适的辅助装置,例如,机械辅助装置,用于定位股骨头的中心,以固定在对准器具上,使得在颈轴与移植轴直径之间的旋转中心至少基本上与股骨头的中心一致。
进一步的方法进一步包括:在切除股骨头时,使用第二钻孔线作为引导工具。
进一步的方法进一步包括:在将制成帽状的移植器放在预制残端上之前移除第二钻孔线。
进一步的方法进一步包括:移植所述移植器,使得在制成帽状的移植器放在预制残端上之后,空腔轴与移植轴一致。
进一步的方法进一步包括:紧固移植器以防止空腔轴相对于移植轴倾斜。
进一步的方法进一步包括:选择根据权利要求1-15中的至少一个权利要求的移植器。
进一步的方法进一步包括:加工股骨头,使得移植轴相对于股骨颈轴的倾斜度对应于移植器的极轴与空腔轴之间的角度。
进一步的方法进一步包括:放置移植器,使得移植器的极轴与股骨颈轴一致。
进一步的方法进一步包括:加工股骨头,使得移植轴相对于股骨颈轴沿额状面和沿矢状面倾斜。
附图说明
本发明将在下文中参照图示在附图中的各实施例更详细地说明。对此,实施例和附图应仅以指导性方式理解,而不应视为限制在权利要求中所描述的主题。附图中的例示被简化;对理解本发明不必要的细节也已省略。
图1显示了移植器的两个实施例。
图2显示了移植器的进一步的实施例。
图3显示了股骨的其上放置有移植器的近部。
图4显示了具有销状固定元件的移植器的进一步的实施例。
图5显示了具有翼状固定元件的移植器的另一实施例。
图6显示了用于制造空腔中的齿结构的冲压器具的实施例。
图7显示了相对于股骨颈轴限定移植轴倾斜度的对准器具的实施例。
附图标记列表如下:
11球部分
13,13′平坦基表面
15极轴
17空腔
19空腔轴
21入口平面
23端面
25套表面
27固定销
29固定翼
31固定翼的边缘侧
33固定翼的平坦侧
35预制残端
37盖开口的边缘
39,39′球表面区域
41轴
43头部
45冲压边沿
47股骨
49股骨头
51股骨颈
53大转子
55对准器具
57第一钻孔线
59第二钻孔线
171凸起部分
A移植轴
M球部分的中心
N股骨颈轴
α在极轴与空腔轴之间的角
2δ锥形开度角
具体实施方式
图1a和1b均显示了用于移植在预制残端上的制成帽状的移植器的实施例,其中预制残端在附图1a和1b中未显示。移植器具有球部分(sphericalsection)11的形式,球部分11具有球中心M、球表面区域39和平坦的基表面13,其中极轴15垂直于基表面13设置。另外,球部分11包括被制成关于空腔轴19旋转对称的空腔17。具有球表面区域39′和基表面13′的球部分以虚线表示,所述球部分不包括空腔,即,所述球部分未与空腔重叠。空腔17具有锥形残端的形状,该形状沿朝向移植器的内部的方向沿空腔轴19渐缩。空腔17通过内表面23、25被限定,所述内表面包括端表面23和锥形套表面25,锥形套表面25具有锥形开度角2δ或锥形半开度角δ。空腔轴19与极轴15具有非零度的角α,并相交于球部分11的中心M。在图1中所示移植器的空腔17的套表面25经过球表面区域39的一部分和平坦基表面13的一部分。因此,空腔17具有通过边缘37限定的盖开口,其中,边缘37的至少第一部分通过具有球表面区域39的套表面25的凹入部(penetration)形成,并设置在垂直于空腔轴19设置的入口平面21中。在所示实例中,边缘的第二部分位于基表面13中。根据图1b的实施例,边缘的第一部分形成为由于由虚线所示的球部分与空腔17重叠而产生的边沿。根据图1a的实施例,边缘的第一部分为圆形。通常,空腔还可具有不同于锥形残端的旋转对称的形状,例如,球体或椭圆体或柱体的形状。图1a和1b所示的移植器,例如可制造为:关于空腔轴旋转对称的空腔始于平坦的基表面形成,并在具有球表面区域、平坦基表面和垂直于平坦基表面的竖立极轴的完整球部分中相对于极轴成一角度,或者,空腔在完整球体中或完整球部分中通过空腔轴形成,然后,平坦基表面垂直于极轴制造。
图2a至图2i所示的实施例通过其锥形开度角2δ和/或通过分别形成在空腔轴19与极轴15之间的角α而相互不同,从而能够覆盖实际发生的不同内翻/外翻位置和/或CCD角。根据图2a至图2c的实施例均具有16°的锥形开度角2δ。根据图2d至图2f的实施例均具有35°的锥形开度角2δ。根据图2g至图2i的实施例均具有50°的锥形开度角2δ。根据图2a,2d和2g的实施例均具有15°的角α。根据图2b,2e和2h的实施例均具有25°的角α。根据图2c,2f和2i的实施例均具有35°的角α。
图3a显示了具有股骨头49、股骨颈51和大转子53的股骨47的侧视图,其中移植器被移植在股骨头49上。此外,图1中所示的球部分的平坦基表面13′以虚线显示。图3b显示通过图3a的股骨47和移植器的纵截面。根据图3b,在预制后保留的股骨残端35的外形状对应于由空腔17或由内表面23、25形成的移植器的内形状。空腔17和预制后的股骨残端35形成相互配合的形式。移植后的移植器从而位于预制后的股骨残端35上的全部区域上,特别地,股骨残端35与移植器之间的锥形残端形状的接触表面使锥形座可作为主固定,并且,通过锥角的相应选择,使持久的压缩应变作用于骨上,从而实现持久的骨刺激。这样,抵御由于缺乏机械刺激所致的骨退化。
为了加强将移植器保持在预制后的股骨残端35上,根据如图4a所示的进一步的实施例的移植器具有多个固定销27,多个固定销27平行于空腔轴定向,并连接至移植器的内表面23、25的端面23,而且突出进入空腔17。固定销27关于空腔轴对称分布。根据此实施例的移植器的固定,显示在图4b中。
在图5a所示的移植器的另一实施例中,固定翼29被设置为固定元件,其平坦侧33平行于空腔轴延伸,并且同样关于空腔轴对称分布。固定翼29邻接移植器的内表面23、25的端面23和锥形套表面25。翼29的向内朝向的边缘侧31均设置在围绕位于移植器的外表面13、39之外的中心的圆上。根据此实施例的移植器的固定,显示在图5b中。用于在预制后的股骨头35中承接固定翼29的缝可使用例如利用合适的量规引导的切割器具通过切割或锯而简单地制造。具有设置在空腔中的翼29的移植器的进一步的示例性实施例显示在图5c中。
例如,所述类型的移植器的端面或套表面或全部内表面被粗喷(roughblast)。这样,促进骨材料向内生长进入移植器。为了更好地保持移植器,锥形套表面可进一步具有钩状结构,例如根据EP0639356的公知结构,所述专利文件在这方面描述了本说明书的整体部分,用于髋壳的外表面,例如,多个固定齿关于空腔轴同心设置,并背离空腔的开口而弯曲进入移植器中。钩状结构可制造为,例如,通过在关于空腔轴对称的球部分11的空腔17的内表面上车削而首先形成周向槽,使得凸起部分171以在槽之间围绕空腔轴的同心环形式产生;这示意性地显示在图6c中。然后,在图6a中以侧视图显示并在图6b中以俯视图显示的器具43,被引进空腔中并且当沿图6c箭头所示的空腔轴方向施加指向空腔中的力时压靠凸起部分,从而通过冲压处理切制出环形凸起部分,使得多个固定齿从每个环形凸起部分产生。在此处理中,固定齿至少在拐角区域另外塑性变形,并弯曲朝向移植器的内部。必须注意的是,在这种方法中,相对于据此预制残端尺度的所希望的尺度,最初产生的空腔必须制造为具有更小尺寸的直径,这是由于空腔通过在其中加工的槽而制成为直径更大。用于产生如上所述的切口的器具的实施例如图6a中所示,其中包括用于夹持器具的轴41和连接至轴41的头部43。头部43包括两个冲压边沿45,两个冲压边沿45相对于轴41相反地设置,并且在如图6a或6c的侧视图中具有与空腔17的套表面的形状配合的外形。所述器具还可以通过星形的方式制成,并具有沿周界分布的多个冲压边沿,从而使多个齿可以沿空腔的周界在一个工序中制造。
移植器显示为例如移植器套件的形式,并具有不同直径的球接合表面和/或在极轴与空腔轴之间的不同角度和/或不同的锥形角,通过该移植器套件,可涵盖在实际中出现的所有的股骨头尺寸、CCD角度和其他指标。球部分的球直径例如处于从38mm至60mm的范围内。
用于制造移植器的材料对本发明不是最重要的;然而,根据在此所考虑的接合表面的直径,由于摩擦学的原因,在实际中使用根据现有技术的例如金属或陶瓷材料的硬质耐磨材料。而且,例如,移植器结合适合的臼杯(acetabular cup)使用,该臼杯具有由相应的耐磨材料制成的接合表面,即,例如,作为具有臼部件的金属股骨部件,其中,该臼部件具有由金属或高度交联聚乙烯形成的接合表面,或作为具有臼部件的陶瓷股骨部件,其中,该臼部件具有由陶瓷材料或高度交联聚乙烯形成的接合表面。然而,最近,也已经致力于制造由软的相对易弯曲的材料形成的重修表面的移植器的接合表面,所述接合表面设置为以类似的硬度或“软度”性能相对于臼接合表面进行接合。
在用于将如前所述制成帽状的移植器移植在股骨头上的示例性方法中,根据图7,第一钻孔线57首先沿股骨颈轴N插入股骨头49中。随后,限定用于移植的移植轴A,该移植轴A至少基本上对应于股骨头49上的主应变方向。为此目的,具有指示和/或量规装置的对准器具55设定在第一钻孔线57上,以限定移植轴A相对于股骨颈轴N的倾斜度,该倾斜度例如基本上对应于在上述移植器的空腔轴与极轴之间的角度。对此,例如,合适的辅助装置,例如机械辅助装置,也用于定位股骨头的中心M,使得在颈轴与移植轴之间的旋转中心可设置在那里。随后,第二钻孔线59沿限定的移植轴A插入股骨头49中。然后,对准器具55和第一钻孔线57被再次移除。随后,第二钻孔线59被用作适于例如锥形残端切刀的合适加工器具的引导工具,以加工股骨头49,从而由此形成预制残端,该预制残端呈现与上述移植器的空腔配合的形状,并关于移植轴A旋转对称。随后,第二钻孔线59再次被移除。然后,移植器特别是上述类型的移植器,被引导至预制残端并放置其上,使得移植器的空腔轴与移植轴一致。在这种情况下,移植器可被紧固以防止空腔轴相对于移植轴倾斜。根据这种方法移植到预制股骨头35上的移植器显示在图3中。移植器在预制股骨头35上定向,使得移植器的极轴15与预制股骨头35的颈轴N一致,并使得移植器的空腔轴19与移植轴A一致,其中移植轴A在实际中对应于股骨头的主应变方向或至少符合良好的近似度。在图3中,移植轴A仅相对于股骨颈轴N沿额状轴(frontal axis)倾斜。然而,通常,移植轴A也可另外地相对于股骨颈轴N沿矢状面(sagittalplane)倾斜;这被称为前倾角(antetorsion)。
根据在此进行的陈述,对于本领域中的技术人员,以权利要求为特征的本发明的进一步实施例变得清晰,这不能总结性地在此显示。
Claims (15)
1.一种制成帽状的移植器,用于移植在预制的股骨头残端上,其中,所述移植器具有球部分(11)的形状,所述移植器包括:平坦基表面(13)和垂直于所述基表面(13)设置的极轴(15),在所述球部分(11)中设置有始于所述基表面(13)的空腔(17),所述空腔(17)旋转对称并且具有空腔轴(19),所述空腔轴(19)被设置为相对于所述极轴(15)成非零的角度,其中,所述极轴(15)和所述空腔轴(19)相互具有角度(α),该角度(α)在15°至50°的范围内,所述空腔(17)具有内表面(25),该内表面(25)具有相对于所述球部分(11)的表面的凹入部,所述内表面(25)的至少一个周界部具有相对于所述球部分(11)的球表面区域(39)的凹入部。
2.根据权利要求1的移植器,其特征在于,所述角度(α)在15°至35°的范围内。
3.根据权利要求1的移植器,其特征在于,所述空腔轴(19)与所述极轴(15)相交。
4.根据权利要求1的移植器,其特征在于,所述球部分(11)具有球中心(M),所述空腔轴(19)在所述球中心(M)处与所述极轴(15)相交。
5.根据权利要求1的移植器,其特征在于,所述球部分(11)具有在从38mm至60mm的范围内的球直径。
6.根据权利要求1的移植器,其特征在于,所述球部分(11)具有球直径和从所述基表面(13)沿所述极轴(15)的方向测量至极点的高度,所述高度等于所述球直径的60%至80%。
7.根据权利要求1的移植器,其特征在于,所述内表面(25)的第一周界部凹入所述球部分(11)的球表面区域(39),并且,所述内表面(25)的第二周界部凹入所述基平面(13)。
8.根据权利要求1的移植器,其特征在于,所述空腔具有锥形残端(17)的形状,该形状沿朝向所述移植器的内部的方向沿所述空腔轴(19)渐缩。
9.根据权利要求8的移植器,其特征在于,所述锥形残端(17)具有锥形开度角(2δ),所述锥形开度角(2δ)在10°至65°的范围内。
10.根据权利要求9的移植器,其特征在于,所述锥形开度角(2δ)在16°至50°的范围内。
11.根据权利要求1的移植器,其特征在于,所述空腔(17)被内腔(23,25)限定,所述内腔(23,25)具有固定装置(27,29),用于将所述移植器固定在所述股骨头残端上。
12.根据权利要求11的移植器,其特征在于,所述固定装置(27,29)设置为关于所述空腔轴(19)对称分布。
13.根据权利要求11的移植器,其特征在于,所述固定装置(27,29)突出进入所述空腔(17)中。
14.根据权利要求11的移植器,其特征在于,所述固定装置包括设置在所述空腔(17)的周界处的钩状结构,所述钩状结构背离所述空腔(17)的开口向内弯曲进入所述移植器的内部。
15.根据权利要求11的移植器,其特征在于,所述固定装置(27,29)包括平行于所述空腔轴(19)定向的多个固定肋、多个固定翼(29)或多个固定销(27)。
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- 2006-08-31 AU AU2006286501A patent/AU2006286501B2/en not_active Ceased
- 2006-08-31 CA CA002621019A patent/CA2621019A1/en not_active Abandoned
- 2006-08-31 JP JP2008528523A patent/JP2009505762A/ja active Pending
- 2006-08-31 CN CN200680036588XA patent/CN101277651B/zh not_active Expired - Fee Related
- 2006-08-31 WO PCT/EP2006/065869 patent/WO2007026003A1/de active Application Filing
- 2006-08-31 EP EP06793106A patent/EP1924208B1/de not_active Not-in-force
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US8394149B2 (en) | 2013-03-12 |
JP2009505762A (ja) | 2009-02-12 |
US20080221700A1 (en) | 2008-09-11 |
AU2006286501B2 (en) | 2012-12-13 |
US20100312353A1 (en) | 2010-12-09 |
AU2006286501A1 (en) | 2007-03-08 |
CA2621019A1 (en) | 2007-03-08 |
US7799087B2 (en) | 2010-09-21 |
EP1924208A1 (de) | 2008-05-28 |
WO2007026003A1 (de) | 2007-03-08 |
EP1924208B1 (de) | 2012-08-22 |
CN101277651A (zh) | 2008-10-01 |
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