WO2019000735A1 - 一种髋关节股骨球头假体及其制备方法 - Google Patents

一种髋关节股骨球头假体及其制备方法 Download PDF

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Publication number
WO2019000735A1
WO2019000735A1 PCT/CN2017/107589 CN2017107589W WO2019000735A1 WO 2019000735 A1 WO2019000735 A1 WO 2019000735A1 CN 2017107589 W CN2017107589 W CN 2017107589W WO 2019000735 A1 WO2019000735 A1 WO 2019000735A1
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WIPO (PCT)
Prior art keywords
spherical surface
ball
hip joint
outer spherical
ball head
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PCT/CN2017/107589
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English (en)
French (fr)
Inventor
朱忠林
朱健
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江苏奥康尼医疗科技发展有限公司
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Publication of WO2019000735A1 publication Critical patent/WO2019000735A1/zh

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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
    • A61F2/3609—Femoral heads or necks; Connections of endoprosthetic heads or necks to endoprosthetic femoral shafts
    • 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
    • A61F2002/30108—Shapes
    • A61F2002/30199—Three-dimensional shapes
    • A61F2002/30242—Three-dimensional shapes spherical
    • 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
    • A61F2002/30316—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
    • 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
    • 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
    • A61F2/3609—Femoral heads or necks; Connections of endoprosthetic heads or necks to endoprosthetic femoral shafts
    • A61F2002/3611—Heads or epiphyseal parts of femur
    • 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
    • A61F2/3609—Femoral heads or necks; Connections of endoprosthetic heads or necks to endoprosthetic femoral shafts
    • A61F2002/3611—Heads or epiphyseal parts of femur
    • A61F2002/3615—Heads or epiphyseal parts of femur having a concave shape, e.g. hemispherical cups

Definitions

  • the present invention generally relates to the field of hip joint prostheses, and more particularly to a hip joint femoral head prosthesis and a method of preparing the same.
  • an object of the present invention is to provide a hip joint femoral head prosthesis and a preparation method thereof, which solve the problem that the surface of the hip joint femoral head is easily worn.
  • the present invention adopts the following technical solutions:
  • a hip joint femoral head prosthesis comprising a ball head body, an outer spherical surface, a concave inner cone or a convex inner cone, the ball head body being a multi-spherical hollow spherical structure, and the outer spherical surface is coated on the spherical surface of the ball head body
  • the inner cone is located at the center of the bottom of the ball body, and a plurality of pits are disposed on the outer spherical surface.
  • the cavities on the outer spherical surface have a diameter of 0.01 mm to 5 mm.
  • the inner surface of the pit on the outer spherical surface is a curved surface
  • the curved surface is a spherical surface or an ellipsoid surface And one of the NURBS surfaces.
  • the material of the ball head main body is the same as the material of the outer spherical surface, and the ball main body and the outer spherical surface have an integral structure.
  • the pits on the outer spherical surface are produced by a method of machining, casting, forging, surface treatment or injection molding.
  • the hip joint femoral ball head prosthesis is obtained by injection molding
  • the material of the outer spherical surface is injected into the surface of the ball body of the step (1) through a mold cavity having a high polished surface to form an outer spherical surface having a naturally contracted pit, thereby preparing a hip joint femoral head. body.
  • the present invention has the following beneficial technical effects as compared with the prior art:
  • a hip joint femoral head prosthesis according to the present invention wherein a plurality of dimples are arranged on the outer spherical surface (ie, the friction surface), so that the fluid in the joint of the human body can be stored in the dimple, so when the hip joint femoral head is opposite to the hip
  • the liquid stored in the pit will form a lubricating film on the friction surface of the hip femoral ball head, thereby reducing the wear on the friction surface of the ball head and prolonging the service life of the prosthesis.
  • the injection molding preparation method of the outer spherical surface of the hip joint femoral head prosthesis of the present invention having the concave feature has the advantages of simple process and good product consistency.
  • FIG. 1 is a schematic illustration of an embodiment of a total hip arthroplasty femoral ball prosthesis of a composite material of the present invention
  • FIG. 2 is a schematic illustration of an embodiment of a hip joint replacement femoral ball prosthesis of a composite material of the present invention
  • FIG. 3 is a schematic illustration of an embodiment of a single-material total hip replacement femoral ball prosthesis of the present invention
  • the inner vertebra of the femoral ball prosthesis of the total hip replacement product is used in conjunction with the femoral head vertebra, so that the concave inner cone, the inner vertebra of the femoral ball prosthesis of the hip replacement product is inserted into the femoral neck, and therefore is convex. Cone.
  • the friction surface is an outer spherical surface.
  • the plurality of dimples disposed on the outer spherical surface of the hip joint femoral head prosthesis of the present invention enable the liquid in the joint of the human body to be stored in the dimple, so when the hip joint femoral head rotates against the acetabulum, the pit is stored.
  • the fluid in the human body forms a lubricating film on the friction surface of the hip femoral ball head (ie, the outer spherical surface), thereby reducing the wear of the outer spherical surface and prolonging the service life of the prosthesis.
  • the cavities on the outer spherical surface are from 0.01 mm to 5 mm, and the maximum caliber of the depth dimples of all the dimples.
  • the curved surface of the pit on the outer spherical surface includes, but is not limited to, a spherical surface, an ellipsoidal surface, a NURBS curved surface, or the like.
  • the plurality of dimples on the same outer spherical surface have the same surface type and size; or a plurality of dimples on the same outer spherical surface have different curved surface types and/or sizes.
  • the pits are spheres of uniform size (i.e., the same size), or combinations of spherical pits of different sizes, or a combination of spherical pits and ellipsoidal pits.
  • the roughness of the inner curved surface of the pit is consistent with the roughness range of the outer spherical surface, and conforms to the industry standard value Ra ⁇ 0.05.
  • the material of the outer spherical surface is one of polyetheretherketone and its derivatives; the material of the ball head main body is one of polyetheretherketone and its derivatives, cobalt-based alloy, titanium alloy, ceramic or at least Two combinations.
  • FIG. 1 An embodiment of a total hip replacement femoral ball prosthesis of a composite material is shown in FIG.
  • the total hip replacement femoral ball prosthesis 1 of the combined material shown includes a ball head body 2, an outer spherical surface 4, and a concave inner cone 3, wherein the material of the outer spherical surface 4 is polyetheretherketone or a derivative thereof, and the ball head
  • the material of the body 3 is a cobalt-based alloy.
  • the outer spherical surface 4 is evenly covered with a plurality of pits, the curved surfaces of the pits are all spherical, and the dimensions are the same, the caliber of the dimples is 0.01 mm, the depth is 0.01 mm, the roughness of the curved surface of the pit and the roughness of the outer spherical surface
  • the range of degrees is consistent, and all meet the industry standard value Ra ⁇ 0.05.
  • FIG. 1 An embodiment of a hip joint replacement femoral ball prosthesis of a composite material is shown in FIG.
  • the total hip replacement femoral ball prosthesis 1 of the combined material shown includes a ball head body 2, an outer spherical surface 4, and a convex inner cone 3, wherein the material of the outer spherical surface 4 is polyetheretherketone or a derivative thereof, and the ball
  • the material of the head main body 3 is a titanium alloy.
  • FIG. 1 An embodiment of a total hip replacement femoral ball prosthesis of a single material is shown in FIG.
  • the single-arm total hip replacement femoral head prosthesis 1 of the single material is shown as a unitary structure, and the material is polyetheretherketone or a derivative thereof.
  • the outer spherical surface 4 is covered with a plurality of concave pits, and the curved surface types of the concave pits are all ellipsoidal surfaces, but the dimensions are not completely the same, wherein the cavities of the dimples are 0.01-5 mm, the depths are all ⁇ 5 mm, and the roughness of the inner curved surface of the pits is external and external.
  • the range of roughness of the spherical surface is consistent, and both meet the industry standard value Ra ⁇ 0.05.
  • the total hip replacement femoral ball prosthesis 1 of the illustrated composite material includes a ball head body 2, an outer spherical surface 4, a concave inner cone 3 and an inner cone sleeve 5, wherein the outer spherical surface 4 and the inner sleeve 5 are made of materials
  • the material of the ball-end main body 3 is polyetheretherketone or a derivative thereof, and is ceramic.
  • the outer spherical surface 4 is covered with a plurality of concave pits, wherein the curved surface type of the concave surface includes but is not limited to a spherical surface, an ellipsoidal surface, a NURBS curved surface, etc., and the dimensions of the concave pits are the same, both caliber: 5 mm, depth: 3 mm, and the inner surface of the pit
  • the roughness is consistent with the roughness of the outer spherical surface, and both meet the industry standard value Ra ⁇ 0.05.
  • the inner end of the ball should be used in conjunction with the metal stem of the femoral stem.
  • Polyetheretherketone and its derivatives are in contact with the metal, which can effectively avoid contact with metal and metal.
  • the risk of corrosion and fretting wear in the contact between porcelain and metal improves the service life of the product.
  • one or several materials suitable for the ball head main body, the outer spherical surface and the inner taper sleeve are schematically illustrated, and are not used to limit the materials of the ball head main body, the outer spherical surface and the inner taper sleeve in the present invention.
  • the pits on the outer spherical surface of the femoral ball of the present invention can be produced by, but not limited to, machining, casting, forging, surface treatment or injection molding.
  • an outer spherical surface having a concave feature is obtained by injection molding or machining.
  • the ball head is a composite material, and the outer spherical surface of the organic material is combined with the ball head body of the metal or ceramic material, the outer spherical surface having the concave feature is obtained by injection molding or machining, and is formed by machining and casting.
  • the body of the ball head is obtained by a method such as forging.
  • the outer spherical surface may be subjected to surface treatment, and the surface treatment of the outer spherical surface includes physical methods (polishing, etc.) and chemical methods (surface modification, etc.).
  • a method of preparing a single material femoral ball prosthesis of the present invention comprising: employing a convex structure on a cavity that is adapted to a pit and having a highly polished profile
  • the mold is injection molded, and the entire femoral ball prosthesis including the outer spherical surface having the concave feature can be obtained by one injection molding.
  • a method of preparing a femoral ball prosthesis of a composite material of the present invention comprising:
  • the outer spherical material is coated on the ball head main body by injection molding, thereby producing a femoral ball head prosthesis including the outer spherical surface having the concave feature and covering the ball head main body.
  • a method for preparing a femoral ball head prosthesis of the composite material of the present invention, wherein the material of the ball head body is a metal or ceramic material comprising:
  • the material of the outer spherical surface is injected into the surface of the ball body of the step (1) through a mold cavity having a high polished surface to form an outer spherical surface having a naturally contracted pit, thereby preparing a hip joint femoral head. body.
  • the present invention utilizes the injection molding characteristics of the difference in local shrinkage of the organic material during the demolding process to achieve injection molding of the outer spherical surface having the pit characteristics.
  • the outer spherical surface of the hip joint femoral head prosthesis having the concave feature of the present invention can be injection molded by various methods, and the process is simple and the product consistency is good.

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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)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

一种髋关节股骨球头假体（1），其包括球头主体（2）、外球面（4）、凹型内锥或凸型内锥（3），该球头主体（2）为多半球的空心球形结构，外球面（4）包覆在球头主体（2）的球面上，内锥（3）位于在球头主体（2）的底部中心，外球面（4）上设置有多个凹坑。该髋关节股骨球头假体（1），在外球面（4）上设置了多个凹坑，使得人体关节内液体可以存储在凹坑内，因此当髋关节股骨球头相对髋臼转动摩擦时，凹坑内存储的人体内液体会在髋关节股骨球头的摩擦表面局部形成润滑膜，从而减少对球头摩擦表面的磨损，延长假体的使用寿命。还公开了一种髋关节股骨球头假体（1）的制备方法。

Description

一种髋关节股骨球头假体及其制备方法 技术领域
本发明总体涉及髋关节假体领域，特别是一种髋关节股骨球头假体及其制备方法。
背景技术
髋关节股骨头病变是骨科最常见的疾病之一。在髋关节股骨头病变的治疗中，常会因为股骨头坏死情况严重而需要更换髋关节股骨头假体，尤其是髋关节股骨球头假体，髋关节股骨球头假体包括全髋置换产品和表髋置换产品。在人体的运动过程中，髋关节股骨球头在髋臼中不断转动，使得髋臼不断摩擦股骨球头的球面。由与目前市场上的髋关节股骨球头假体的表面为光滑球面，表面无任何凹凸细节，因此股骨球头假体直接与臼杯摩擦，容易被磨损，从而发生松动，影响使用效果，严重时还必须重新更换股骨球头假体，给患者造成不便和经济负担。
发明内容
针对上述问题，本发明的目的是提供一种髋关节股骨球头假体及其制备方法，解决髋关节股骨球头表面易磨损的问题。
为实现上述目的，本发明采取以下技术方案：
一种髋关节股骨球头假体，包括球头主体、外球面、凹型内锥或凸型内锥，该球头主体为多半球的空心球形结构，外球面包覆在球头主体的球面上，内锥位于在球头主体的底部中心，外球面上设置有多个凹坑。
进一步地，外球面上的凹坑的口径为0.01mm－5mm。
进一步地，外球面上的凹坑的内表面为曲面，该曲面为球面、椭球面 和NURBS曲面中的一种。
进一步地，同一外球面上的多个凹坑的曲面类型和尺寸完全相同；或者，同一外球面上的多个凹坑具有不同的曲面类型和/或尺寸。
进一步地，外球面的材料为聚醚醚酮及其衍生物中的一种；球头主体的材料为聚醚醚酮及其衍生物、钴基合金、钛合金、陶瓷中的一种或至少两种组合。
进一步地，髋关节股骨球头假体还包括内锥套，该内锥套紧密贴合设置在凹型内锥或凸型内锥的表面，内椎套的材料为聚醚醚酮及其衍生物中的一种。
进一步地，球头主体的材料和外球面的材料相同，并且球头主体和外球面为整体结构。
进一步地，外球面上的凹坑通过机械加工、铸造成型、锻造成型、表面处理或注塑成型的方法制得。
一种上述的髋关节股骨球头假体的制备方法，采用型腔上设置有与外球面上的凹坑相适应的凸起结构且具有高抛光型面的模具进行注塑成型，
(1)当球头主体和外球面的材料为相同的单一材料时，通过注塑一体制得髋关节股骨球头假体；
(2)当球头主体与外球面的材料不同时，预热球头主体后，将外球面的材料通过注塑包覆在具有光滑表面的球头主体上，从而制得髋关节股骨球头假体。
一种上述的髋关节股骨球头假体的制备方法，当球头主体的材料为金属或陶瓷材料时：
(1)在球头主体表面制备规定尺寸、数量和分布的具有抛光表面的初级凹坑，预热球头主体；
(2)将外球面的材料通过具有高抛光表面的模具型腔，注塑在步骤(1)的球头主体表面，形成具有自然收缩的凹坑的外球面，从而制得髋关节股骨球头假体。
由于采用以上技术方案，本发明与现有技术相比具有如下有益技术效果：
1.本发明的一种髋关节股骨球头假体，在外球面(即摩擦面)上设置了多个凹坑，使得人体关节内液体可以存储在凹坑内，因此当髋关节股骨球头相对髋臼转动摩擦时，凹坑内存储的人体内液体会在髋关节股骨球头的摩擦表面局部形成润滑膜，从而减少对球头摩擦表面的磨损，延长假体的使用寿命。
2.本发明的髋关节股骨球头假体的具有凹坑特征的外球面的注塑成型制备方法具有工艺简单、产品一致性好的优点。
附图说明
以下附图仅旨在于对本发明做示意性说明和解释，并不限定本发明的范围。其中：
图1是本发明的组合材料的全髋关节置换股骨球头假体的实施例的示意图；
图2是本发明的组合材料的表髋关节置换股骨球头假体的实施例的示意图；
图3是本发明的单一材料的全髋关节置换股骨球头假体的实施例的示意图；
图4是本发明的具有内椎套的股骨球头假体的实施例的示意图。
附图标记：
1-股骨球头假体 2-球头主体 3-内椎 4-外球面 5-内椎套
具体实施方式
为了本发明的目的、技术方案及优点更加清楚明白，下面对照附图结合实施例，为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用以解释本发明，并不用于限定本发明。
本发明的一种髋关节股骨球头假体，包括球头主体、外球面、凹型内锥或凸型内锥，该球头主体为多半球的空心球形结构，外球面包覆在球头主体的球面上，内锥位于在球头主体的底部中心，外球面上设置有多个凹坑。全髋置换产品的股骨球头假体的内椎与股骨柄椎头配合使用，因此为凹型内锥，表髋置换产品的股骨球头假体的内椎插入股骨颈使用，因此为凸型内锥。
在髋关节股骨球头假体的使用中，摩擦面为外球面。本发明的髋关节股骨球头假体的外球面上设置的多个凹坑，使得人体关节内液体可以存储在凹坑内，因此当髋关节股骨球头相对髋臼转动摩擦时，凹坑内存储的人体内液体会在髋关节股骨球头的摩擦表面(即外球面)局部形成润滑膜，从而减少对外球面的磨损，延长假体的使用寿命。
优选地，为了髋关节股骨球头假体的使用中具有更好的适配性和舒适性，外球面上的凹坑的口径为0.01mm－5mm，所有凹坑的深度凹坑的最大口径。
优选地，外球面上的凹坑的曲面包括但不限于球面、椭球面、NURBS曲面等。
优选地，同一外球面上的多个凹坑的曲面类型和尺寸完全相同；或者，同一外球面上的多个凹坑具有不同的曲面类型和/或尺寸。例如，凹坑为大小均匀(即尺寸相同)的球面，或者不同尺寸的球面凹坑组合，或者球面凹坑和椭球面凹坑的组合。
优选地，外球面上的多个凹坑均匀分布在其上，进一步优选地，根据接触面的摩擦程度和受力程度的不同，设计不同位置的凹坑曲面，使其更好的适配人体活动。
优选地，凹坑内曲面的粗糙度与外球面的粗糙度范围一致，符合行业标准值Ra≤0.05。
优选地，外球面的材料为聚醚醚酮及其衍生物中的一种；球头主体的材料为聚醚醚酮及其衍生物、钴基合金、钛合金、陶瓷中的一种或至少两种组合。
如图1所示为组合材料的全髋关节置换股骨球头假体的实施例。示出的组合材料的全髋关节置换股骨球头假体1中包括球头主体2、外球面4、凹型内锥3，其中外球面4的材料为聚醚醚酮或其衍生物，球头主体3的材料为钴基合金。外球面4上均匀覆盖有多个凹坑，凹坑的曲面均为球面，且尺寸相同，凹坑的口径均为0.01mm，深度均为0.01mm，凹坑内曲面的粗糙度与外球面的粗糙度范围一致，且均符合行业标准值Ra≤0.05。
如图2所示为组合材料的表髋关节置换股骨球头假体的实施例。示出的组合材料的全髋关节置换股骨球头假体1中包括球头主体2、外球面4、凸型内锥3，其中外球面4的材料为聚醚醚酮或其衍生物，球头主体3的材料为钛合金。外球面4上覆盖有多个凹坑，凹坑的曲面类型和尺寸均不完全相同，其中凹坑的曲面类型包括但不限于球面、椭球面、NURBS曲面等，凹坑的口径为0.01-5mm，深度均≤5mm，凹坑内曲面的粗糙度与外球面的粗糙度范围一致，且均符合行业标准值Ra≤0.05。
如图3所示为单一材料的全髋关节置换股骨球头假体的实施例。示出的单一材料的全髋关节置换股骨球头假体1中球头主体和外球面为整体结构，材料为聚醚醚酮或其衍生物。外球面4上覆盖有多个凹坑，凹坑的曲面类型均为椭球面，但是尺寸不完全相同，其中凹坑的口径为0.01-5mm，深度均≤5mm，凹坑内曲面的粗糙度与外球面的粗糙度范围一致，且均符合行业标准值Ra≤0.05。
如图4所示为组合材料的全髋关节置换股骨球头假体的实施例。示出的组合材料的全髋关节置换股骨球头假体1中包括球头主体2、外球面4、凹型内锥3和内锥套5，其中外球面4和内锥套5的材料均为聚醚醚酮或其衍生物，球头主体3的材料为陶瓷。外球面4上覆盖有多个凹坑，其中凹坑的曲面类型包括但不限于球面、椭球面、NURBS曲面等，凹坑的尺寸都相同，均为口径：5mm，深度：3mm，凹坑内曲面的粗糙度与外球面的粗糙度范围一致，且均符合行业标准值Ra≤0.05。
在全髋关节产品中，球头内椎需和金属材质的股骨柄椎头配合使用，采用聚醚醚酮及其衍生物与金属接触，能有效避免因金属与金属接触、陶 瓷与金属接触所存在的腐蚀和微动磨损等风险，提高产品的使用寿命。
在上述实施例中，示意性地列举了适用于球头主体、外球面和内锥套的一种或几种材料，并不用于限制本发明中球头主体、外球面和内锥套的材料类型。应该知道，本发明的股骨球头假体的球头主体、外球面和内锥套可以由任何合适的材料制得。
本发明的股骨球头假体外球面上的凹坑可以通过但不限于机械加工、铸造成型、锻造成型、表面处理或注塑成型的方法制得。
当股骨球头假体为单一材料时，通过注塑或者机加工等方法制得具有凹坑特征的外球面。当球头为组合材料时，且为有机材料的外球面和金属或者陶瓷材料的球头主体结合时，采用注塑或者机加工等方法制得具有凹坑特征的外球面，通过机械加工、铸造成型、锻造成型等方法制得球头主体。此外，为了提高外球面的光滑度，还可以对外球面进行表面处理，外球面的表面处理包括物理方法(抛光等)和化学方法(表面改性等)。
根据本发明的一个实施例，一种本发明的单一材料的股骨球头假体的制备方法，该方法包括采用型腔上设置有与凹坑相适应的凸起结构且具有高抛光型面的模具进行注塑成型，一次注塑成型便可制得包括具有凹坑特征的外球面的整个股骨球头假体。
根据本发明的另一个实施例，一种本发明的组合材料的股骨球头假体的制备方法，该方法包括：
(1)将具有光滑球面的球头主体放入设置有与凹坑相适应的凸起结构且具有高抛光型面的模具内，预热球头主体；
(2)通过注塑成型将外球面的材料包覆在球头主体上，从而制得包括具有凹坑特征且包覆球头主体的外球面的股骨球头假体。
还根据本发明的另一个实施例，一种本发明的组合材料的股骨球头假体的制备方法，其中球头主体的材料为金属或陶瓷材料，该方法包括：
(1)在球头主体表面制备规定尺寸、数量和分布的具有抛光表面的初级凹坑，预热球头主体；
(2)将外球面的材料通过具有高抛光表面的模具型腔，注塑在步骤(1)的球头主体表面，形成具有自然收缩的凹坑的外球面，从而制得髋关节股骨球头假体。
本发明利用有机材料在脱模过程中局部收缩的差异的注塑特性，实现具有凹坑特征的外球面的注塑成型。
本发明的髋关节股骨球头假体的具有凹坑特征的外球面的可以通过多种方法注塑成型，工艺简单、产品一致性好。
应该知道的是，其他任何凸起结构设计和制作工艺，等同于凹面结构工艺，均在本专利的保护范围内。
以上所述实施仅表达了本发明的实施方式，其描述较为具体和详细，但并不能因此而理解为对本发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进，这些都属于本发明的保护范围。因此，本发明专利的保护范围应以所附权利要求为准。

Claims (10)

  1. 一种髋关节股骨球头假体，其特征在于，包括：
    球头主体，所述球头主体为多半球的空心球形结构；
    外球面，所述外球面包覆在所述球头主体的球面上；
    凹型内锥或凸型内锥，所述内锥位于在所述球头主体的底部中心；
    其中，所述外球面上设置有多个凹坑。
  2. 如权利要求1所述的一种髋关节股骨球头假体，其特征在于，所述凹坑的口径为0.01mm－5mm。
  3. 如权利要求1所述的一种髋关节股骨球头假体，其特征在于，所述凹坑的内表面为曲面，所述曲面为球面、椭球面和NURBS曲面中的一种。
  4. 如权利要求1所述的一种髋关节股骨球头假体，其特征在于，同一所述外球面上的多个所述凹坑的曲面类型和尺寸完全相同；或者，同一所述外球面上的多个所述凹坑具有不同的曲面类型和/或尺寸。
  5. 如权利要求1所述的一种髋关节股骨球头假体，其特征在于，
    所述外球面的材料为聚醚醚酮及其衍生物中的一种；
    所述球头主体的材料为聚醚醚酮及其衍生物、钴基合金、钛合金、陶瓷中的一种或至少两种组合。
  6. 如权利要求5所述的一种髋关节股骨球头假体，其特征在于，所述髋关节股骨球头假体还包括内锥套，所述内锥套紧密贴合设置在所述凹型内锥或凸型内锥的表面，所述内椎套的材料为聚醚醚酮及其衍生物中的一种。
  7. 如权利要求5述的一种髋关节股骨球头假体，其特征在于，所述球头主体的材料和所述外球面的材料相同，并且所述球头主体和所述外球面为整体结构。
  8. 如权利要求1所述的一种髋关节股骨球头假体，其特征在于，所述 凹坑通过机械加工、铸造成型、锻造成型、表面处理或注塑成型的方法制得。
  9. 一种如权利要求1所述的髋关节股骨球头假体的制备方法，其特征在于，采用型腔上设置有与所述凹坑相适应的凸起结构且具有高抛光型面的模具进行注塑成型，
    (1)当所述球头主体和所述外球面的材料为相同的单一材料时，通过注塑一体制得所述髋关节股骨球头假体；
    (2)当所述球头主体与所述外球面的材料不同时，预热所述球头主体后，将所述外球面的材料通过注塑包覆在具有光滑表面的所述球头主体上，从而制得所述髋关节股骨球头假体。
  10. 一种如权利要求1所述的髋关节股骨球头假体的制备方法，其特征在于，当所述球头主体的材料为金属或陶瓷材料时：
    (1)在所述球头主体表面制备规定尺寸、数量和分布的具有抛光表面的初级凹坑，预热所述球头主体；
    (2)将外球面的材料通过具有高抛光表面的模具型腔，注塑在步骤(1)的所述球头主体表面，形成具有自然收缩的凹坑的外球面，从而制得所述髋关节股骨球头假体。
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CN107595440B (zh) * 2017-09-29 2020-05-29 北京爱康宜诚医疗器材有限公司 髋臼假体
CN110074900B (zh) * 2019-02-01 2024-04-02 北京爱康宜诚医疗器材有限公司 关节垫片假体及具有其的关节假体
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