CN104185457A - 用于自体股骨头的无骨水泥表面置换假体 - Google Patents

用于自体股骨头的无骨水泥表面置换假体 Download PDF

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CN104185457A
CN104185457A CN201380010952.5A CN201380010952A CN104185457A CN 104185457 A CN104185457 A CN 104185457A CN 201380010952 A CN201380010952 A CN 201380010952A CN 104185457 A CN104185457 A CN 104185457A
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replacement prosthesis
surface replacement
screw thread
pitch
synostosis
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M·孔茨
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Ceramtec GmbH
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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
    • 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
    • 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
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/30004—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
    • A61F2002/30028—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis differing in tissue ingrowth capacity, e.g. made from both ingrowth-promoting and ingrowth-preventing parts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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
    • A61F2002/30593—Special structural features of bone or joint prostheses not otherwise provided for hollow
    • 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
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    • 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
    • A61F2002/3085—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with a threaded, e.g. self-tapping, bone-engaging surface, e.g. external surface
    • 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
    • A61F2002/3085—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with a threaded, e.g. self-tapping, bone-engaging surface, e.g. external surface
    • A61F2002/30851—Multiple threadings
    • 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
    • A61F2002/3085—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with a threaded, e.g. self-tapping, bone-engaging surface, e.g. external surface
    • A61F2002/30873—Threadings machined on non-cylindrical external surfaces
    • 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
    • A61F2002/3092—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth having an open-celled or open-pored structure
    • 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
    • A61F2002/3093—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth for promoting ingrowth of bone tissue

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
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  • Prostheses (AREA)

Abstract

本发明涉及一种用于自体股骨头(3)的陶瓷表面置换假体(1)，其包括外球面(5)和内部接收空间(7)，所述内部接收空间(7)具有内侧面(4)。本发明的目的是防止由植入过程引起的骨组织的坏疽，还因此阻止了内部骨组织的损失。根据本发明，这通过所述内侧面(4)设置有骨性结合涂层(6)、或至少在一些区域中以骨性结合方式设计、和/或所述内侧面(4)设计为自成形螺纹(8)来实现。

Description

用于自体股骨头的无骨水泥表面置换假体
本发明涉及一种用于自体股骨头的无骨水泥陶瓷表面置换假体，其包括外球面以及具有内侧面的内部接收空间。
表面置换假体也称作表面重修头、髋关节杯或帽假体。
在自体股骨头或髋关节头退化的情形中，本领域公知的是将由金属或陶瓷制成的表面置换假体置于股骨头上并通过骨水泥将其向下锚定。表面置换假体仅置换股骨头的关节软骨，并在关节软骨下的股骨头形式上或结构上基本没被破坏时使用。
表面置换假体的外表面具有球形形状且直接***自体骨盆或***合成窝中，所述合成窝转而锚固在自体骨盆中。
到目前为止，陶瓷表面置换假体主要地基于已知的金属设计且通常由骨水泥固定。内部接收空间的内侧面设置有骨水泥凹窝和对中销。
考虑到所施加的骨水泥在硬化期间的放热反应，存在骨组织热损伤和坏疽的危险。
由于骨水泥导致的热量生成，无骨水泥形式的表面置换假体将是非常有利地。
另一个优势将是不采用对中销来实施，由后续销钻孔产生的骨组织的损失减少。
本发明的目的是以如下方式改善根据权利要求1前序部分的陶瓷表面置换假体，即在植入期间不产生骨组织的坏疽，并且同时不发生内部骨组织的损失。内部骨组织是从外侧不可见的组织，这与外部骨组织相反，所述外部骨组织从外部可见且在表面置换假体放置前被处理。
根据本发明，该目的通过在内侧面至少某些区域设置有骨性结合涂层、或通过骨性结合成形、和/或通过将内侧面形成为自成形螺纹来实现。
骨性结合表面涂层在B.Theelke、Mi.Kuntz、M.Zipperle、S.Eichhorm、T.Boxleiter、T.Pandorf、R.Burgkart的“Development of osseointegrative ceramiccoatings based on ZPTA-mechanical characterization and influence on the substrate”(Bioceramics 2010年第1期，第1-4页)中描述。
通过使用内侧面的骨性结合表面涂层或配置，实现了股骨头上表面置换假体的牢固且持久锚定。例如通过在陶瓷表面置换假体的未完成状态中形成侧面的表面附近区域以获得合适开口孔结构，来实现内侧面的骨性结合配置。
陶瓷表面置换假体烧结状态的内表面的涂层也是合适的，例如具有钛合金制成的结构化涂层。
本发明的一个特别重要的方面是表面置换假体无需骨水泥而固定在股骨头上。这适用于所有的创造性实施方式中。同样在所有实施方式中，没有轴向对中销置于接收空间中。
可替代地或结合骨性结合涂层或骨性结合成形，所述侧面形成为自成形螺纹。这样，极大地改善了锚定，从而能够省却骨水泥固定或对中销。
螺纹形成为圆锥或圆柱形状。如果螺纹是圆锥形，股骨头通常应该至少被拧入。
令人惊奇地是，已经发现螺纹的螺距对表面置换假体在股骨头的锚固具有相当大的影响。螺纹的螺距对确保表面置换假体在股骨头上不发生松动来说是必要的。螺距越大，将表面置换假体旋转在股骨头上所需的力越大。换言之：对于固定的表面置换假体来说，如果通过摩擦力作用于表面置换假体上的扭矩低于可在表面置换假体的螺纹位于股骨上时旋转该表面置换假体的扭矩，那么表面置换假体保持牢固地锚定在股骨头上。因此，螺纹的螺距是本发明的重要特征。
已经示出了螺纹螺距对于手术后紧接着的表面置换假体的最初固定是极其重要的，特别是防止由于假体不期望的逆时针旋转引起的固定的松动：在手术结束时将带有表面置换假体的股骨头***髋臼之后，由于自体韧带拉力和肌肉张力，假体与股骨头的接触面是轴向预张紧的。螺纹的陡度越大，对于不期望的连接松动而言所需的扭矩就越大；该松动扭矩由于运动练习期间腿的旋转运动而发生在表面置换假体的对称轴周围。随着骨组织不断向股骨头和表面置换假体之间的骨性结合成形的边界层内生长，骨组织元件(“骨小梁”)和骨性结合结构之间的实打实的连接增加了接触面的稳定性。
因此，螺纹应该设计为具有大于2mm/转的螺距。甚至更好的是具有大于4mm/转的螺距。最好的结果是由大于6mm/转的螺距获得的。该螺纹还可以是多起点的。
螺纹圈的数量、齿形状以及螺距能够在主要的扭转可靠性以及轴向稳定性方面在宽范围内被最优化，并且将在陶瓷表面置换假体的初级机加工期间在商业数控机床上被制造。此外，最高为90°的非常陡峭的角是可行的，并且这些能够通过冲击仪器来安装。
本发明在下文中通过多幅附图来进一步解释。在所有附图中描绘了无骨水泥表面置换假体。
图1示意性地描绘了穿过自体股骨颈9和股骨头3的截面，其安装有根据本发明的由陶瓷制成的表面置换假体1。假体1的外表面是球形成形的并且直接***自体骨盆中或***合成窝中，所述合成窝转而直接地或间接地锚定在自体骨盆中。
表面置换假体1包括内部接收空间，其具有内侧面4，表面置换假体1通过所述内侧面4安装在股骨头3上。接收空间的内侧面4优选地是圆锥形的。但接收空间也能够是球形的，如图1中所示。
根据本发明，表面置换假体1不需要骨水泥而固定在股骨头3上。这适用于本发明的所有实施方式。同样，它没有在接收空间中设置轴向对中销。
为了锚定表面置换假体1，内侧面4设置有骨性结合涂层6或其被骨性结合地形成。
在本发明的另一个实施方式中，接收空间4的内侧面制造为自成形螺纹。这些实施方式通过图2-6而更加详细地解释。另外，在这些实施方式中，内侧面还能够设置有骨性结合涂层或被骨性结合地产生。
图2说明了根据本发明的表面置换假体1，其中内部接收空间的侧面4形成为截头圆锥形并设置有多起点高螺距螺纹。图2中描绘了2-起点的自成形螺纹作为实例。内侧面4在螺纹上另外地设置有骨性结合涂层6。骨性结合涂层6还设计为直接至骨涂层。在手术期间该部位的准备工作通过合适设计的外科铣削器械来进行。在放置表面置换假体1后，通过右转来将其牢固固定。为了校正高度，表面置换假体1能够通过左转来再次松动并在必要时该部位能够再次铣削。
由于圆锥形部位的对中效果，能够省却对中销，这具有组织保持的优点。
在图2中，圆锥形2-起点螺纹的螺距是恒定的，例如，每个完整转的轴向路径是常量。间隔(t)，例如这里两个螺纹顶端之间的距离是s/2。
图3描绘了具有s/4的间隔的圆锥形自成形4-起点螺纹的表面置换假体1。
图4描绘了穿过具有2-起点螺纹8的表面置换假体1的截面以及图5描绘了具有4-起点螺纹的表面置换假体1。
图6描绘了根据本发明的具有圆柱自成形6-起点螺纹的表面置换假体1。这里仅高于螺纹的接收空间的球形部分2具有骨性结合涂层6。
所有螺纹的螺距是1至20mm/转；优选为2至10mm/转，并且特别优选为3至6mm/转。螺纹的起点的选择依赖于螺距和螺纹形式。因而，对于1-起点螺纹，螺距优选为1-2mm/转；对于2-起点螺纹，螺距优选为2-4mm/转，而对于3-起点螺纹，螺距优选为3-6mm/转。
参考标记的解释说明：
1  表面置换假体
2  高于螺纹的接收空间的球形部分
3  股骨头
4  侧面
5  球形面
6  骨性结合涂层
7  接收空间
8  螺纹
9  股骨颈

Claims (6)

1.一种用于自体股骨头(3)的陶瓷表面置换假体(1)，包括外球面(5)和内部接收空间(7)，所述内部接收空间(7)具有内侧面(4)，其特征在于所述内侧面(4)至少部分地设置有骨性结合涂层(6)、或者被骨性结合地形成、和/或所述内侧面(4)形成为自成形螺纹(8)。
2.根据权利要求1所述的表面置换假体，其特征在于所述螺纹(8)是圆锥形的或圆柱形的。
3.根据权利要求1或2所述的表面置换假体，其特征在于所述螺纹(8)形成为具有大于2mm/转的螺距。
4.根据权利要求3所述的表面置换假体，其特征在于所述螺纹(8)形成为具有大于4mm/转的螺距。
5.根据权利要求4所述的表面置换假体，其特征在于所述螺纹(8)形成为具有大于6mm/转的螺距。
6.根据权利要求1或2所述的表面置换假体，其特征在于所述螺纹(8)形成为多起点。
CN201380010952.5A 2012-02-24 2013-02-12 用于自体股骨头的无骨水泥表面置换假体 Pending CN104185457A (zh)

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