CN101321506A - 髋表面置换植入物 - Google Patents

髋表面置换植入物 Download PDF

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CN101321506A
CN101321506A CNA2006800457082A CN200680045708A CN101321506A CN 101321506 A CN101321506 A CN 101321506A CN A2006800457082 A CNA2006800457082 A CN A2006800457082A CN 200680045708 A CN200680045708 A CN 200680045708A CN 101321506 A CN101321506 A CN 101321506A
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implant
femoral head
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hip resurfacing
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伊骜安尼斯·佛拉肖斯
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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
    • A61F2/32—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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/74—Devices for the head or neck or trochanter of the femur
    • A61B17/742—Devices for the head or neck or trochanter of the femur having one or more longitudinal elements oriented along or parallel to the axis of the neck
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/842—Flexible wires, bands or straps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B17/8665—Nuts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
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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
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B2017/8655—Pins or screws or threaded wires; nuts therefor with special features for locking in the bone
    • 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
    • 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
    • A61F2002/30795—Blind bores, e.g. of circular cross-section
    • A61F2002/30797—Blind bores, e.g. of circular cross-section internally-threaded
    • 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
    • A61F2002/30879—Ribs
    • 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
    • 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
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00011—Metals or alloys
    • 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
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00389—The prosthesis being coated or covered with a particular material
    • A61F2310/00395—Coating or prosthesis-covering structure made of metals or of alloys

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Abstract

本发明是一种髋表面置换植入物，其用于髋表面置换关节成形术，即，在具有患病的髋部的患者身上执行的外科改造，在此手术中，外科医生采用抛光的金属球壳替换股骨头的表面。本发明的植入物由具有抛光的半球形的外部表面和内部半球形凹面的金属壳(1)构成，该内部凹面具有带螺纹(4)的耳轴(2)和子午线叶片(3)，并且为了植入物和骨头之间的骨性结合，被完全地金属多孔涂覆。本发明的植入物被固定在适当地轮廓匹配处理过的股骨头上，并借助于预应力线(5)稳定，该预应力线对股骨头和股骨颈部钻孔，并从较大的转子穿出。该线在近端与外壳耳轴(2)上的螺纹(4)连接，远端与螺母垫圈组合(6)连接，通过其张紧，可获得预应力的确定。

Description

髋表面置换植入物
技术领域
本发明是一种髋表面置换植入物，其用于髋表面置换关节成形术，即，在具有患病的髋关节的患者身上执行的外科改造。
背景技术
具有患病的髋关节(例如，骨关节炎)的患者通常要进行全髋部替换，以缓解疼痛并保证关节的功能恢复。在这种改造中用植入物替换骨盆的髋臼，股骨的上部(骨颈和骨头)也以植入物替换，这些植入物由抛光的球形轴承表面组装而成。
但在某些情况下临床可以保存股骨颈和股骨头，而将外科改造限制于股骨头轴承表面的替换(髋表面置换关节成形术)。这是通过抛光的金属植入物实现的，其几何形状类似于薄壁球形外壳，该外壳固定于轮廓相应的股骨头。
目前已有的髋表面置换植入物证明具有下面的缺点：
抛光的外壳的外部表面是一个这样的球面部分，其相当于北半球加上从赤道向南纬延伸20+20度，甚至于30+30度的球面部分。结果，外壳的圆周边缘是相对有限的，因此，只对股骨头做很小的外周轮廓匹配处理是不可能将其固定在股骨头上的。为了固定这样的外壳，必须进行大的外周骨去除，直到被轮廓匹配处理的股骨头最终到达其初段的较窄的股骨颈的轮廓。这要使解剖区域的强度作出让步，并且通常由于增加的应力导致与股骨颈的骨折有关的手术后并发症。
此外，目前可获得的髋表面置换植入物通过内部中心销的方法保证固定，该销的横截面直径高达10mm，为了将其插入，需要通过相当的股骨头和股骨颈钻孔方法进一步骨去除。这更加地减小了解剖区域的强度并且同时影响了局部的血管分布。
此外，目前已有的髋表面置换植入物通过丙烯酸树脂接合剂的方法固定，这意味着保证了金属外壳和做了轮廓匹配处理的股骨头的暴露的松质骨之间的接合。但是在接合剂聚合的放热反应过程中，下面的松质骨的完整性要进一步作出让步。
发明内容
本发明是一种用于髋表面置换关节成形术的植入物，其有效地克服了上面提到的目前已有的植入物的缺点，并且同时引入了对于正在研究中的解剖区域的生物力学很重要的优点。本发明的植入物包括：作为主要部件的剖光的金属外壳、预应力线和具有垫圈的螺母。所有的部件均在附图中被示出。
具体实施方式
本发明的植入物的金属外壳(1)是具有抛光的外部(凸面)表面的180度(精确的半球形)的薄壁球形外壳。金属外壳的内部(凹面)表面也是半球形的。这提供了一个重要的益处，即，外壳的圆周边缘是最大的；这样，只需经过很小的外周轮廓匹配处理就可固定在股骨头上，从而避免了大量的骨去除。
此外，本发明的植入物的金属外壳(1)在内部(凹面)表面的中心轴上具有一短耳轴(2)。这提供了一个重要的益处，即，无需沿着股骨头和股骨颈在深处钻很大的孔，从而保存了基本骨头和局部的血管的完整性。
进而，本发明的植入物的金属外壳(1)在内部(凹面)表面上具有薄的子午线叶片(3)，而在短耳轴的中心上具有用于连接预应力线的阴螺纹(4)。通过这两种手段(叶片和预应力)，可以充分保证直接的术后扭转和轴向稳定性。为了使植入物长期稳定，金属外壳的内部表面被金属多孔涂覆，其在预应力的有利影响下，导致永久地骨性结合到基本骨头上。
本发明的植入物的预应力线(5)的整个长度上都具有相当于耳轴(2)的阴性部分的螺纹。预应力线(5)的一端是套针。这样，由于预应力线的一端可以在耳轴内螺接，通过沿着适当的方向钻入股骨头和股骨颈，套针端可以借助于螺母垫圈组合(6)稳定在较大转子区域上。然后，可以在预应力线上施加必要的预应力。
在外科髋表面置换过程中，本发明的植入物的使用通过下面的步骤实现：
a)沿着通过手术前适当的计划得到的方向，借助于预应力线对股骨头和股骨颈钻孔，一直到较大的转子。在远端，预应力线从延伸到较大的转子之外的股骨上穿出，而在近端则防止完全插入。
b)将预应力线保持在位，其随后用作必要操作的中心化子导向器，这些必要的操作是根据本发明的植入物的尺寸对股骨头所做的少量的轮廓匹配处理和对耳轴凹槽的打磨。
c)将金属外壳完全连接在带螺纹的预应力线上，随后从较大转子一侧牵引预应力线(连同连接其上的外壳一起)。
d)使用螺母垫圈组合，以将线的远端安全地锁定在较大的转子的皮层突出的部分。
e)将螺母垫圈组合张紧，其同时起到如下作用：使金属外壳下沉到做了轮廓匹配处理的股骨头上，使内部子午线叶片嵌入到在下面的骨头上，最后沿着张紧线确定所需的预应力。
f)在预应力确定之后，切掉伸到螺母外的预应力线部分。
本发明的髋表面置换植入物有效地克服了目前已有的植入物的缺点，极大地在股骨头和股骨颈部位保存了更多和更好的血管化的松质骨。同时，本发明的植入物引入了预应力的优点，有利于直接手术后的植入物稳定性，而不会扰乱区域的长期的生物力学，相反却提高了骨质的股骨颈的强度。

Claims (2)

1.一种髋表面置换植入物，其是金属的，外壳部分(1)在几何上是薄壁球形，用于固定在轮廓适当的股骨头上，其特征在于，抛光的凸面是精确的半球形的，在基本的骨头上的固定通过预应力线(5)的方法获得，该线穿过股骨头和股骨颈钻孔，并从较大的转子里穿出来，在近端连接于外壳的耳轴(2)上的螺纹(4)，在远端连接于一螺母垫圈组合(6)，通过其张紧，可获得预应力的确定。
2.如权利要求1所述的髋表面置换植入物，其特征在于，外壳的内部凹面为的半球形，其具有薄的子午线叶片(3)、位于半球形的中心轴上的短耳轴(2)和为了植入物与下面的骨头之间的骨性结合而设置的完全金属的多孔涂层。
CNA2006800457082A 2005-12-05 2006-12-05 髋表面置换植入物 Pending CN101321506A (zh)

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US (1) US8632602B2 (zh)
EP (1) EP1968496B1 (zh)
JP (1) JP2009518096A (zh)
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CN110368140A (zh) * 2019-08-05 2019-10-25 北京爱康宜诚医疗器材有限公司 股骨植入物
CN110368141A (zh) * 2019-08-05 2019-10-25 北京爱康宜诚医疗器材有限公司 股骨植入物
CN110368142A (zh) * 2019-08-05 2019-10-25 北京爱康宜诚医疗器材有限公司 股骨头假体、股骨假体组件及髋关节组件
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CN111166533A (zh) * 2019-12-30 2020-05-19 天衍医疗器材有限公司 一种表面置换股骨头的制造工艺以及股骨头

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JP2009518096A (ja) 2009-05-07
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WO2007066156A1 (en) 2007-06-14
ZA200805459B (en) 2009-08-26
PL1968496T3 (pl) 2011-10-31
CA2632214C (en) 2011-09-13
CA2632214A1 (en) 2007-06-14
ATE506033T1 (de) 2011-05-15
EP1968496B1 (en) 2011-04-20
GR1005306B (el) 2006-10-05
EP1968496A1 (en) 2008-09-17
DK1968496T3 (da) 2011-08-15
BRPI0619440A2 (pt) 2011-10-04
AU2006323003A1 (en) 2007-06-14
US8632602B2 (en) 2014-01-21
US20090048681A1 (en) 2009-02-19
CY1112343T1 (el) 2015-12-09
DE602006021477D1 (de) 2011-06-01
AU2006323003B2 (en) 2013-05-23

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