WO2010063167A1 - 人工股骨柄及其人工全髋关节置换假体 - Google Patents

人工股骨柄及其人工全髋关节置换假体 Download PDF

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Publication number
WO2010063167A1
WO2010063167A1 PCT/CN2009/070354 CN2009070354W WO2010063167A1 WO 2010063167 A1 WO2010063167 A1 WO 2010063167A1 CN 2009070354 W CN2009070354 W CN 2009070354W WO 2010063167 A1 WO2010063167 A1 WO 2010063167A1
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Prior art keywords
femoral stem
artificial
prosthesis
artificial femoral
curve
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PCT/CN2009/070354
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English (en)
French (fr)
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王岩
郑诚功
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北京纳通投资有限公司
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Priority to JP2010547030A priority Critical patent/JP2011529347A/ja
Priority to US12/811,351 priority patent/US20100286792A1/en
Publication of WO2010063167A1 publication Critical patent/WO2010063167A1/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
    • 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
    • A61F2/3662—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
    • A61F2/32—Joints for the hip
    • A61F2/36—Femoral heads ; Femoral endoprostheses
    • 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
    • A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30331—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementarily-shaped recess, e.g. held by friction fit
    • A61F2002/30332—Conically- or frustoconically-shaped protrusion and recess
    • 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
    • A61F2002/30904—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
    • 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
    • A61F2/34—Acetabular cups
    • A61F2002/3401—Acetabular cups with radial apertures, e.g. radial bores for receiving fixation screws
    • 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
    • A61F2/34—Acetabular cups
    • A61F2002/3412—Acetabular cups with pins or protrusions, e.g. non-sharp pins or protrusions projecting from a shell surface
    • A61F2002/3425—Acetabular cups with pins or protrusions, e.g. non-sharp pins or protrusions projecting from a shell surface the outer shell having non-meridian protrusions, e.g. fins or wings, located in planes inclined or perpendicular with respect to the equatorial plane
    • 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
    • A61F2002/365—Connections of heads to necks
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0033—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit

Definitions

  • the present invention relates to artificial transplantation techniques, and more particularly to a specific artificial femoral stem for avascular necrosis of the femoral head and an artificial total hip replacement prosthesis using the same. Background technique
  • Avascular Necrosis is a common clinical disease.
  • the cause of the disease is that the patient's blood supply to the femoral head is damaged due to various causes, causing ischemia, necrosis and collapse of the femoral head, often leading to severe hip dysfunction. , is one of the most common and difficult diseases.
  • titanium alloy material is still considered to be the best internal fixation material, because this material has good biocompatibility and elastic modulus similar to cortical bone, so the reaction of foreign matter is small, and theoretically it will bring less Stress occlusion, but this does not mean that the fit of the prosthesis to the bone is no longer important. On the contrary, this puts a higher requirement for the fixation of the proximal femur, because there is a large amount of cancellous bone at the proximal end of the femoral medullary cavity.
  • the elastic modulus of plants in titanium alloys is quite different, and the existing prosthesis designs do not examine the fit of the proximal femur and the cortical bone of the prosthesis to a suitable height. Clinically experienced doctors always achieve an acceptable fit by excessively removing the cancellous bone to adapt to the shape of the prosthesis, which is tantamount to "cutting the foot.”
  • Factors affecting bone and prosthesis type include age, race, gender, etc., and whether the disease type is a factor affecting the shape of the medullary cavity has not been determined, but the latest research finds that more and more literature supports femoral neck fracture and femur. Shapes are related.
  • the joint replacement caused by avascular necrosis of the femoral head in China accounts for almost 40% of all joint replacements.
  • the age of AVN patients undergoing artificial hip replacement surgery is only older than the congenital hip group, compared with patients with osteoarthritis and femoral neck fractures. The age is much smaller, so the survival time of the prosthesis, that is, the long-term stability of the prosthesis is particularly important.
  • the present invention provides an artificial femur designed according to statistical data of femur characteristics of AVN patients.
  • the shank replacement prosthesis ensures that it has good matching characteristics with the femoral features of AVN patients to obtain good long-term stability.
  • Another object of the present invention is to provide an artificial total hip replacement prosthesis using the artificial femoral stem.
  • An artificial femoral stem comprising a neck segment and an anchoring segment, wherein: the inner curve of the anchoring segment is an anatomical curve of a corresponding portion of the AVN patient.
  • the inner curved portion has a length of 10% to 100% of the total length of the anchoring portion.
  • the anterior curve of the anchoring segment is an anatomical curve of the corresponding portion of the AVN patient.
  • the front curve portion is 10% to 100% of the total length of the anchoring portion.
  • the anchoring section is a short shank structure.
  • the distal end of the anchoring section is highly polished.
  • the portion of the anchoring section that is highly polished beyond the distal end has a wide coating.
  • An artificial total hip replacement prosthesis comprising the artificial femoral stem, further comprising: a hip white prosthesis for matching the artificial femoral stem.
  • the technical effects of the present invention are:
  • the curve of the anchoring section of the artificial femoral stem of the present invention is designed according to the inner curve of the femoral medullary cavity of the AVN patient obtained according to the statistical data of the femoral skeletal structure of the AVN patient, and the artificial femoral stem prosthesis processed according to the curve makes
  • the medial and lateral curves of the femoral stem prosthesis have a higher degree of fit with the femoral medullary cavity of the AVN patient, thereby achieving a perfect fit between the artificial prosthesis and the hard bone of the patient's femoral medullary wall to improve the distal length of the prosthesis. Stability. Therefore, the problem of poor compatibility between the prosthesis and the femoral medullary cavity and poor long-term stability has been solved.
  • the distal end of the artificial femoral stem of the present invention has a highly polished surface, is easier to remove, and can reduce the stress shielding of the distal end fixation, and the rest of the anchoring section has a wide coating, which provides long-term bone ingrowth. Biological fixation.
  • FIG. 1 is a schematic view showing the structure of an artificial total hip replacement prosthesis of the present invention
  • Figure 2 is a schematic view showing the outline of the artificial femoral stem of the present invention.
  • Figure 3 is a side elevational view of the artificial femoral stem shown in Figure 2.
  • an artificial total hip replacement prosthesis of the present invention including a matching artificial femoral stem 1 and an hip white cup 4, the artificial femoral stem 1 including a neck segment 2 and an anchoring section 3, hip
  • the white cup 4 can be placed over the neck section 2, wherein the anchoring section 3 of the artificial femoral stem 1 coincides with the anatomical curve of the corresponding part of the AVN patient.
  • the anchoring section 3 of the artificial femoral stem 1 is designed with a short handle to retain more bone mass and is consistent with the anatomical curve of the corresponding portion of the AVN patient.
  • Figure 2 is a schematic view showing the outline of the artificial femoral stem 1
  • Figure 3 is a side view thereof.
  • the curve 1 1 is the inner curve of the femoral stem
  • the curve 12 is the curve of the anterior side of the femoral stem.
  • the design of the parameters is statistically determined by statistical processing of the femur bone structure characteristics of the AVN patient. In this embodiment, use
  • the length of the portion of the inner curve 11 accounts for 10% to 100% of the total length of the anchoring portion 3.
  • the length of the front curve 12 portion is 10% to 100% of the total length of the anchoring section 3.
  • the lateral and posterior curves of the femur perpendicular to the curves 11, 12, and the inclination angle of the femoral stem and the inclination of the neck of the femoral stem can be mapped.
  • the difference in data is small.
  • This replacement prosthesis is more in line with AVN than the replacement prosthesis prepared in the past according to the statistical data of the femur bone structure of western normal people.
  • the patient's femoral geometry has a higher degree of conformity with the hard bone of the patient's femoral medullary wall, which can improve the long-term stability of the replacement prosthesis. Therefore, the problem of poor fit and long-term stability of the prosthesis and the femoral medullary cavity is solved.

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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)

Description

人工股骨柄及其人工全髋关节置换假体
技术领域
本发明涉及人工移植技术， 特别是涉及一种针对股骨头缺血性坏死的特异性人工股骨 柄及采用该柄的人工全髋关节置换假体。 背景技术
股骨头缺血性坏死 (Avascular Necrosis 简称 AVN)是临床常见疾病， 其病因在于患者 由于各种病因， 破坏了股骨头的血供导致股骨头缺血、 坏死、 塌陷， 常导致严重髋关节功 能障碍， 是目前常见而又难治的疾病之一。
人工全髋关节假体置换是 AVN晚期患者的一种主要的治疗手段。
为解决人工全髋关节假体置换技术中水泥型假体远期松动率逐年增高的问题， 从上世 纪七十年代开始在股骨柄侧应用非骨水泥固定技术， 而在髋白侧的应用是从八十年代开始 的， 为获得假体的稳定曾经有过许多不同的设计， 但只有部分假体获得了成功， 经过深入 研究， 人们逐渐发现只有在假体和骨之间达到相当的密合度， 微动小于 28 μ πι到 50 μ πι时 才能获得可靠的骨长入， 因而假体的几何形状决定了这种密合程度， 也决定了假体的远期 存活率。 然而， 过去已有的表面沟槽、 各种组配式设计， 以及近年来的解剖型设计均是通 过正常西方人的测量数据经过统计学处理后得到的平均数值设计的， 而且这些根据西方人 骨骼数据设计的假体很难和国人的骨骼特征获得较好的匹配， 至于为此采取的表面涂层改 进， 各种螺钉、 棘突等辅助固定设计也仅仅是提供了假体早期稳定， 而实现假体远期稳定 的必由之路就是增加假体和骨的型合度。
目前认为钛合金材料仍是最佳的内固定物材料， 因为这种材质具有良好的生物相容性 和与皮质骨相仿的弹性模量， 因而异物反应小， 理论上也会带来较少的应力遮挡， 但是这 并不意味着假体与骨的型合度不再重要， 相反这为股骨近端的固定提出了更高的要求， 因 为股骨髓腔近端存在大量的松质骨， 其与钛合金内植物的弹性模量相差很多， 而现有假体 设计都没有将假体股骨近端与髓腔皮质骨的型合度提到合适的高度来审视。 临床上有经验 的医生总是通过过多的去除松质骨去适应假体的形状来实现可接受的型合度匹配， 这无异 于 "削足适履"。
影响骨与假体型合度的因素包括年龄、 种族、 性别等因素， 而疾病种类是否为影响髓 腔形状的因素尚未定论， 但从最新的研究发现越来越多的文献支持股骨颈骨折与股骨形状 具有相关性。 我国股骨头缺血性坏死导致的关节置换几乎占所有关节置换的 40%，施行人工髋关节置 换手术的 AVN患者年龄仅大于先天性髋关节病人组， 而比骨关节炎和股骨颈骨折患者的年 龄小很多， 故假体的存活时间， 即实现假体远期稳定尤为重要。
临床中， 通过 186例 AVN患者和 213例正常人髋关节影像学数据， 分析股骨侧髓腔差 异、 股骨前倾角差异及髋白特征差异， 发现我国 AVN患者的髓腔前侧和内外侧曲线和常人 存在统计学差异， 以倒香槟型为主， 这与术中所见相符。 因此， 根据 AVN患者的骨骼特征 来制作与其骨骼特征相匹配的置换假体具有重要的意义。 发明内容
本发明为了解决现有人工髋关节置换假体不能很好地与股骨进行型合、 难以保证假体 远期稳定的技术问题， 本发明提供一种按照 AVN患者股骨特征统计数据而设计的人工股骨 柄置换假体， 保证其与 AVN患者的股骨特征具有较好的匹配特性， 以获得良好的远期稳定。
本发明的另一个目的在于提供一种应用该人工股骨柄的人工全髋关节置换假体。
本发明的技术方案如下：
一种人工股骨柄， 包括颈部段和锚定部段， 其特征在于： 所述锚定部段的内侧曲线为 AVN患者对应部位的解剖曲线。
所述锚定部段的内侧曲线的方程式为y = ±AlX 3 + A3x2±A3x + A4; 其中 、 A2、 A3、 A4 均为系数， 取值范围为 -0.17000〜0.04054， A2取值范围为 -2.00586〜7.10783， A3取值范围 为 -87.75095〜40.25685， A4取值范围为 -246.58554〜338.85144。
所述内侧曲线部分长度为锚定部段总长度的 10%〜100%。
所述锚定部段的前侧曲线为 AVN患者对应部位的解剖曲线。
所述锚定部段的前侧曲线的方程式为y = ±BlX 3 + B3x2±B3x + B4; 其中 、 B2、 B3、 B4 均为系数， 取值范围为 -0.17000〜2.61338， B2取值范围为 -75.67478〜8.53086， B3取值范围 为 -73.68055〜720.37993， B4取值范围为 -3125.92948〜283.55694。
所述前侧曲线部分为锚定部段总长度的 10%〜100%。
所述锚定部段为短柄结构。
所述锚定部段的远端高抛光。
所述锚定部段远端高抛光之外的部分具有广泛的涂层。
一种人工全髋关节置换假体， 包括所述的人工股骨柄， 其特征在于： 还包括与所述人 工股骨柄匹配使用的髋白假体。
本发明的技术效果在于： 本发明人工股骨柄的锚定部段的曲线是按照 AVN患者的股骨骨骼结构特征统计数据所 得到的 AVN患者的股骨髓腔内侧曲线而设计的， 依照该曲线加工的人工股骨柄假体， 使得 股骨柄假体的内侧曲线和外侧曲线与 AVN患者的股骨髓腔具有更高的型合度， 从而实现人 工假体与患者股骨髓内腔壁的硬质骨完美贴合， 以提高假体的远期稳定性。 从而解决一直 以来所存在的假体与股骨髓腔的型合度差、 远期稳定性差的问题。
本发明的人工股骨柄远端具有高抛光的表面， 更为易于取出， 且可减少远端固定的应 力遮挡， 且锚定部段的其余部位具有广泛的涂层， 为远期骨长入提供生物固定。 附图说明
图 1所示为本发明的人工全髋关节置换假体的结构示意图；
图 2所示为本发明的人工股骨柄的轮廓示意图；
图 3所示为图 2所示的人工股骨柄的侧面视图。 具体实施方式
以下结合附图对本发明的人工全髋关节置换假体做进一步说明。
图 1所示为本发明的人工全髋关节置换假体的结构示意图，包括相匹配的人工股骨柄 1 和髋白杯 4， 人工股骨柄 1包括颈部段 2和锚定部段 3， 髋白杯 4可套装在颈部段 2上， 其 中人工股骨柄 1的锚定部段 3与 AVN患者对应部位的解剖曲线相一致。 本实施例中人工股骨柄 1的锚定部段 3采用短柄设计， 以保留更多的骨量， 且与 AVN 患者对应部位的解剖曲线相一致。
图 2所示为人工股骨柄 1的轮廓示意图， 图 3为其侧向视图。 其中曲线 1 1为股骨柄的内侧曲线， 曲线 12为股骨柄的前侧曲线， 其参数的设计采用 统计学方法， 经过对 AVN患者的股骨骨骼结构特征测量统计处理而得， 本实施例中， 采用
A_A、 B_B、 C_C、 D_D、 E_E、 F_F、 G_G、 H_H 等均分的各截面， 经数理统计， 测绘出
AVN患者与正常人的股骨骨骼结构特征相区别的曲线。
本发明通过对大量的 AVN患者的股骨骨骼结构的临床统计， 经数理统计， 测绘出内侧 曲线 11的方程式为 y = ±AlX 3 + A3x2±A3x + A4; 其中 Α2、 Α3、 Α4均为系数， Α^)值范围 为 -0.17000〜0.04054， A2取值范围为 -2.00586〜7.10783， A3取值范围为 -87.75095〜40.25685， A4取值范围为 -246.58554〜338.85144。 内侧曲线 11部分的长度占锚定部段 3总长度的 10%〜100%。
图 3中， 前侧曲线 12的方程式为 y = ±BlX3 + B3x2±B3X + B4; 其中 ^、 B2、 B3、 B4均为 系数， 取值范围为 -0.17000〜2.61338， B2取值范围为 -75.67478〜8.53086， B3取值范围为 -73.68055〜720.37993， B4取值范围为 -3125.92948〜283.55694。
前侧曲线 12部分的长度占锚定部段 3总长度的 10%〜100%。
同理， 参照同样的设计方法， 可以测绘出与所述曲线 11、 12 位于相垂直方向的股骨 外侧和后侧曲线， 以及股骨柄前倾角度和股骨柄颈部的倾角， 这部分数据与常人的数据差 异较小， 将上述数据汇总， 即可以建立与 AVN患者的股骨骨骼结构特征更为接近的数学统 计模型， 并依照这种完全按照 AVN患者的股骨骨骼结构特征建立的数学模型， 加工制造出 符合 AVN患者的股骨骨骼结构特征的人工全髋关节置换假体， 这种置换假体与过去完全依 照西方正常人的股骨骨骼结构特征统计数据所制备的置换假体相比较， 更为符合 AVN患者 的股骨几何外形， 与患者股骨髓内腔壁的硬质骨具备更高的型合度， 可以提高置换假体的 远期稳定性。 从而解决了假体与股骨髓腔的型合度差、 远期稳定性差的问题。

Claims

权 利 要 求
、 一种人工股骨柄， 包括颈部段和锚定部段， 其特征在于： 所述锚定部段的内侧曲线为 AVN患者对应部位的解剖曲线。
、 根据权利要求 1 所述的人工股骨柄， 其特征在于： 所述锚定部段的内侧曲线的方程式 ¾ y = ±AlX 3 + A3x2士 A3x + A4; 其中 A、 A2、 A3、 A4均为系数， A1取值范围为 -0.17000〜 0.04054， A2取值范围为 -2.00586〜7.10783， A3取值范围为 -87.75095〜40.25685， A4取值 范围为 -246.58554〜338.85144。
、 根据权利要求 2所述的人工股骨柄， 其特征在于： 所述内侧曲线部分长度为锚定部段 总长度的 10%〜100%。
、 根据权利要求 2所述的人工股骨柄， 其特征在于： 所述锚定部段的前侧曲线为 AVN患 者对应部位的解剖曲线。
、 根据权利要求 3所述的人工股骨柄， 其特征在于： 所述锚定部段的前侧曲线的方程式 ¾ y = iB^ + B^2士 B3x + B4; 其中 ^、 B2、 B3、 B4均为系数， B1取值范围为 -0.17000〜 2.61338， B2取值范围为 -75.67478〜8.53086， B3取值范围为 -73.68055〜720.37993， B4取 值范围为 -3125.92948〜283.55694。
、 根据权利要求 4所述的人工股骨柄， 其特征在于： 所述前侧曲线部分长度为锚定部段 总长度的 10%〜100%。
、 根据权利要求 1所述的人工股骨柄， 其特征在于： 所述锚定部段为短柄结构。
、 根据权利要求 1所述的人工股骨柄， 其特征在于： 所述锚定部段的远端高抛光。 、 根据权利要求 1 所述的人工股骨柄， 其特征在于： 所述锚定部段远端高抛光之外的部 分具有广泛的涂层。
0、 采用权利要求 1一 9之一所述的人工股骨柄的人工全髋关节置换假体， 包括所述的人工 股骨柄， 其特征在于： 还包括与所述人工股骨柄匹配使用的髋白假体。
PCT/CN2009/070354 2008-12-04 2009-02-04 人工股骨柄及其人工全髋关节置换假体 WO2010063167A1 (zh)

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