JP6728554B2 - Cobra Femoral Stem Prosthesis - Google Patents

Cobra Femoral Stem Prosthesis Download PDF

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JP6728554B2
JP6728554B2 JP2018074856A JP2018074856A JP6728554B2 JP 6728554 B2 JP6728554 B2 JP 6728554B2 JP 2018074856 A JP2018074856 A JP 2018074856A JP 2018074856 A JP2018074856 A JP 2018074856A JP 6728554 B2 JP6728554 B2 JP 6728554B2
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femoral stem
femoral
stem
prosthesis
neck
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王岩
張国強
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王岩
張国強
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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
    • A61F2/3662—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
    • A61F2/3607—Femoral heads ; Femoral endoprostheses including proximal or total replacement of the femur
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28—Materials for coating prostheses
    • A61L27/30—Inorganic materials
    • A61L27/306—Other specific inorganic materials not covered by A61L27/303 - A61L27/32
    • 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
    • A61F2002/3082—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
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30836—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves knurled
    • 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
    • A61F2002/3678—Geometrical features
    • 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
    • A61F2310/00407—Coating made of titanium or of Ti-based alloys

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Cardiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Dermatology (AREA)
  • Prostheses (AREA)

Description

本発明は人工プロテーゼ置換技術分野に関し、特に大腿ステム遠位部が突起した縦向きリッジ構造であるコブラ型大腿ステムプロテーゼに関する。 The present invention relates to the field of artificial prosthesis replacement technology, and more particularly to a cobra type femoral stem prosthesis having a longitudinal ridge structure in which the distal portion of the femoral stem is projected.

先天性股関節形成不全（先股脱）とは、股関節に異常が生じる疾病である。患者の前傾角度が通常の人に比べて明らかに大きい。手術を行う医師は、患者の前傾角度に基づき、適切なプロテーゼを選択できなければ、プロテーゼの角度の配置が悪く、回旋中心の再設置が適切ではない等の一連の問題が生じる。これにより、術後のプロテーゼ転位、プロテーゼ磨耗、術後の関節機能の不良等の合併症の発症の可能性を大幅に増やし、全股関節置換手術の效果に深刻な影響を及ぼす。股関節の活動範囲を狭め、大腿ステムと寛骨臼のコンポーネントに衝突が生じやすくなり、手術の成功率を低くする。 Congenital hip dysplasia (progenital prolapse) is a disease in which an abnormality occurs in the hip joint. The patient's anteversion angle is obviously larger than that of a normal person. If the surgeon cannot select an appropriate prosthesis based on the patient's anteversion angle, the angle of the prosthesis is not properly arranged, and a series of problems such as improper re-installation of the center of rotation arises. As a result, the possibility of complications such as postoperative prosthesis dislocation, prosthesis wear, and postoperative joint function failure is greatly increased, and the effect of total hip replacement surgery is seriously affected. It reduces the range of activity of the hip joint, increases the likelihood of collisions between the femoral stem and acetabular components, and reduces the success rate of surgery.

既存のプロテーゼには、組み合わせ型大腿ステムプロテーゼとＳ−ＲＯＭプロテーゼがある。組み合わせ型大腿ステムプロテーゼは、中国人の大腿骨の骨髄腔と理想的なマッチングができず、組み合わせ型大腿ステムプロテーゼの安定性は悪く、長期生存率は低い。組み合わせ型の大腿ステムプロテーゼは埋め込みも復位も難しい上に、犠牲にする骨の量も多い。Ｓ−ＲＯＭプロテーゼの組み合わせ結合部は、プロテーゼが折れるリスクが増え、金属研摩粉が発生する可能性があり、プロテーゼの寿命に影響する。組み合わせ型大腿ステムプロテーゼとＳ−ＲＯＭプロテーゼには全てコンポーネント間の磨耗と骨腐食等の問題が存在し、プロテーゼの生体適合性を低くする。メーカーは、大量在庫のコンポーネントの製作コストを負わなければならず、コストが高くなり、小規模メーカーには不利である。組み合わせ型大腿ステムプロテーゼとＳ−ＲＯＭプロテーゼの大腿ステムは、全て患者の大腿骨の骨髄腔の幾何学的形状と前傾角度に基づき、設置されなければならず、手術中の設置は、手術時間を伸ばし、患者の痛みを増やし手術の成功率を下げる。 Existing prostheses include combined femoral stem prostheses and S-ROM prostheses. The combined femoral stem prosthesis does not ideally match the bone marrow cavity of the Chinese femur, the combined femoral stem prosthesis has poor stability, and the long-term survival rate is low. The combined femoral stem prosthesis is difficult to implant and reposition, and also sacrifices a large amount of bone. The combined connection of the S-ROM prosthesis increases the risk of the prosthesis breaking and the possibility of metal polishing powders, which affects the life of the prosthesis. The combined femoral stem prosthesis and S-ROM prosthesis all have problems such as wear between components and bone erosion, which reduces the biocompatibility of the prosthesis. Manufacturers have to bear the cost of manufacturing large inventory of components, which is costly and disadvantageous to smaller manufacturers. The femoral stem of the combined femoral stem prosthesis and the S-ROM prosthesis must all be installed based on the geometric shape and anteversion angle of the bone marrow cavity of the patient's femur, and the installation during surgery is performed at the operation time. To increase the patient's pain and reduce the success rate of surgery.

本発明は、既存のプロテーゼに存在するコンポーネント間の磨耗、骨腐食、プロテーゼの生体適合性が悪く、在庫量が多く、コストが高く、プロテーゼを手術中に設置しなければならないため手術時間が長くなり、患者の痛みを増やし、手術の成功率が低くなる等の問題を解決するコブラ型大腿ステムプロテーゼを提供する。 The present invention eliminates wear between components present in existing prostheses, bone erosion, poor biocompatibility of the prosthesis, high inventory, high cost, and long operation time due to the prosthesis having to be installed during surgery. The present invention provides a cobra femoral stem prosthesis that solves problems such as increased patient pain and reduced success rate of surgery.

上述の技術問題を解決するため、本発明の実施形態においてコブラ型大腿ステムプロテーゼを提供する。前記先天性股関節形成不全用大腿ステムプロテーゼは、順番に連結した大腿ステムコーン、大腿骨頚部およびステムを含む。前記ステムは、大腿ステム近位部、大腿ステム中位部および大腿ステム遠位部を含む。前記大腿ステムコーンは円形状をしている。前記大腿骨頚部の一端と大腿ステム近位部は連結しており、両者の間に偏角を備える前記大腿骨頚部の別の一端は大腿ステムコーンの大径端部と連結しており、前記大腿ステム近位部の表面には多数の環状の微細溝を設置している。前記大腿ステム遠位部の外表面に複数の縦に伸びた縦向きリッジを設置している。 In order to solve the above technical problems, a cobra femoral stem prosthesis is provided in an embodiment of the present invention. The congenital hip dysplasia femoral stem prosthesis includes a femoral stem cone, a femoral neck and a stem that are connected in sequence. The stem includes a femoral stem proximal portion, a femoral stem medial portion and a femoral stem distal portion. The femoral stem cone has a circular shape. One end of the femoral neck and the femoral stem proximal portion are connected, and another end of the femoral neck having a declination between them is connected to the large diameter end of the femoral stem cone, A large number of annular fine grooves are provided on the surface of the proximal part of the femoral stem. A plurality of vertically extending longitudinal ridges are provided on the outer surface of the distal portion of the femoral stem.

ここで、前記大腿ステム近位部の軸線と前記大腿骨頚部の軸線と間の鋭角は０°〜３５°または１４５°〜１８０°である。 Here, the acute angle between the axis of the femoral stem proximal portion and the axis of the femoral neck is 0° to 35° or 145° to 180°.

ここで、前記ステム中心線と大腿骨頚部中心線との間に１２０°〜１４０°の夾角をなす。 Here, an included angle of 120° to 140° is formed between the stem center line and the femoral neck center line.

ここで、前記大腿ステム遠位部の外表面に４〜１０本の縦向きリッジを設置しており、前記縦向きリッジの高さは０．５５〜０．６５ｍｍである。 Here, 4 to 10 vertical ridges are provided on the outer surface of the distal portion of the femoral stem, and the height of the vertical ridge is 0.55 to 0.65 mm.

ここで、前記大腿骨頚部の横断面は楕円形である。 Here, the cross section of the femoral neck is elliptical.

ここで、前記環状微細溝の幅は１．０〜１．５ｍｍであり、深さは０．４〜０．５ｍｍである。 Here, the annular fine groove has a width of 1.0 to 1.5 mm and a depth of 0.4 to 0.5 mm.

ここで、前記大腿ステム近位部の外表面にＴｉコーティングを吹き付けており、前記Ｔｉコーティングの厚さは５０〜８００μｍである。 Here, a Ti coating is sprayed on the outer surface of the proximal portion of the femoral stem, and the thickness of the Ti coating is 50 to 800 μm.

本発明における上述の手段技術的手段の有益な効果は以下の通りである。 The beneficial effects of the above-mentioned technical means of the present invention are as follows.

前記手段において、本発明のプロテーゼは一体型を採用しており、コンポーネントの組み立てが必要なく、コンポーネント間の磨耗と骨腐食等の問題を解消し、在庫量を減らし、コストを削減し、あらゆる規模のメーカーに適用できる。本発明の大腿ステムのデザインは、患者の大腿骨の骨髄腔の幾何学的形状に使用する大腿ステムに９０％以上合致する。本発明の前傾角度は０°または１５°または３５°であり、手術中の患者は自身の前傾角度に基づき、適切な規格のプロテーゼを選択でき、手術時間を短縮し、患者の痛みを減らし、手術の成功率を高める。本発明の大腿ステム近位部の外表面にはＴｉコーティングを吹き付けており、プロテーゼの生体適合性を強化し強度とプラスチックの靭性は人体骨と相互にマッチングしており、骨細胞および軟部組織の成長、増殖に良好な条件を整える。これにより、プロテーゼと患者の大腿骨との完全なマッチングを実現し、特に発育性股関節形成不全（ＤＤＨ）、先天性股関節脱臼（ＣＤＨ）患者に適合する。 In the above-mentioned means, the prosthesis of the present invention adopts an integral type, which eliminates the need for assembling the components, eliminates the problems such as wear and bone corrosion between the components, reduces the inventory quantity, reduces the cost, and reduces the scale. Applicable to manufacturers. The femoral stem design of the present invention is more than 90% compatible with the femoral stem used in the bone marrow cavity geometry of the patient's femur. The anteversion angle of the present invention is 0°, 15° or 35°, and the patient during surgery can select a prosthesis of appropriate standard based on his anteversion angle, which shortens the operation time and reduces the patient's pain. Reduce and increase the success rate of surgery. The outer surface of the proximal part of the femoral stem of the present invention is sprayed with a Ti coating to enhance the biocompatibility of the prosthesis, and the strength and toughness of the plastic are mutually matched with the human body bone. Establish good conditions for growth and proliferation. This provides a perfect match between the prosthesis and the patient's femur and is particularly suited to patients with developing hip dysplasia (DDH) and congenital hip dislocation (CDH).

本発明におけるコブラ型大腿ステムプロテーゼの構造図である。1 is a structural diagram of a cobra type femoral stem prosthesis according to the present invention. 本発明におけるコブラ型大腿ステムプロテーゼの冠状面を示す図である。It is a figure which shows the coronal surface of the cobra-type femoral stem prosthesis in this invention. 本発明における人工α大腿ステムプロテーゼの偏角を示す図である。It is a figure which shows the declination of the artificial alpha femoral stem prosthesis in this invention.

１、大腿ステムコーン
２、大腿骨頚部
３、ステム
４、大腿ステム近位部
５、大腿ステム中位部
６、大腿ステム遠位部
７、環状微細溝
８、縦向きリッジ 1, femoral stem cone 2, femoral neck 3, stem 4, femoral stem proximal portion 5, femoral stem middle portion 6, femoral stem distal portion 7, annular fine groove 8, longitudinal ridge

本発明が解決しようとする技術問題、技術的手段および利点をより明確にするため、以下に詳細な説明と図面を結合して本発明の好ましい実施形態を説明する。 To make the technical problems, technical means and advantages to be solved by the present invention clearer, the preferred embodiments of the present invention will be described below in combination with the detailed description and the drawings.

図１から図３が示す、本発明コブラ型大腿ステムプロテーゼは、順番に連結した大腿ステムコーン１、大腿骨頚部２およびステム３を含む。前記ステム３は、大腿ステム近位部４、大腿ステム中位部５および大腿ステム遠位部６を含む。前記大腿ステムコーン１は円形状をしている。前記大腿骨頚部２の一端と大腿ステム近位部４は連結しており、両者の間に偏角を備える。前記大腿骨頚部２の別の一端は大腿ステムコーン１の大径端と連結している。 The cobra femoral stem prosthesis of the present invention, shown in FIGS. 1-3, comprises a femoral stem cone 1, a femoral neck 2 and a stem 3 connected in sequence. The stem 3 includes a femoral stem proximal portion 4, a femoral stem medial portion 5 and a femoral stem distal portion 6. The femoral stem cone 1 has a circular shape. One end of the femoral neck portion 2 and the femoral stem proximal portion 4 are connected to each other, and a declination angle is provided therebetween. The other end of the femoral neck 2 is connected to the large diameter end of the femoral stem cone 1.

前記大腿ステム近位部４の外表面には多数の環状の微細溝７を設置しており、プロテーゼと骨界面との接触面積を効果的に増加し、プロテーゼ埋め込み後の安定性を保証する。本実施形態において、前記環状微細溝は好ましくはジグザグ溝であり、幅は１．０〜１．５ｍｍであり、深さは０．４〜０．５ｍｍである。 A large number of annular microgrooves 7 are provided on the outer surface of the femoral stem proximal portion 4 to effectively increase the contact area between the prosthesis and the bone interface and ensure stability after implantation of the prosthesis. In the present embodiment, the annular fine groove is preferably a zigzag groove having a width of 1.0 to 1.5 mm and a depth of 0.4 to 0.5 mm.

ここで、大腿ステム近位部４の軸線と大腿骨頚部２の軸線との間の夾角はα角である、α角は前傾角度であり、α角は０°〜３５°または１４５°〜１８０°であり、α角の好適手段は、１５°、３５°、１４５°および１６５°である。 Here, the included angle between the axis of the femoral stem proximal portion 4 and the axis of the femoral neck 2 is the α angle, the α angle is the anteversion angle, and the α angle is 0° to 35° or 145° to 180° and preferred means of α angle are 15°, 35°, 145° and 165°.

さらに、前記ステム３の中心線と大腿骨頚部２の中心線との間に１２０°〜１４０°の夾角をなし、好適値はβ＝１３０°であり、この夾角のデザインは、人体解剖・生理の構造により一層合致する。 Further, an included angle of 120° to 140° is formed between the center line of the stem 3 and the center line of the femoral neck 2, and a preferable value is β=130°, and the included angle is designed for human anatomy/physiology. More closely matches the structure of.

前記大腿ステム遠位部の外表面に４〜１０本の縦向きリッジ８を設置しており、好適値は８本であり、プロテーゼの初期安定性と回旋防止性能を強化する。本本実施形態において、前記縦向きリッジの高さは０．５５〜０．６５ｍｍであり、即ち、縦向きリッジの外径は大腿ステムの基礎の直径より約１．２５ｍｍ大きい。 Four to ten vertical ridges 8 are provided on the outer surface of the distal part of the femoral stem, and a preferable value is eight, which enhances the initial stability and anti-rotation performance of the prosthesis. In the present embodiment, the height of the vertical ridge is 0.55-0.65 mm, that is, the outer diameter of the vertical ridge is about 1.25 mm larger than the diameter of the base of the femoral stem.

ここで、前記大腿骨頚部２の横断面は楕円形であり、プロテーゼの活動範囲を増やし、大腿骨頚部２と全寛骨臼の内側の磨耗を減らす。 Here, the cross section of the femoral neck 2 is elliptical, which increases the range of activity of the prosthesis and reduces the wear of the femoral neck 2 and the inside of the total acetabulum.

ここで、前記大腿ステム近位部４の表面には、Ｔｉコーティングを吹き付けており、前記Ｔｉコーティングの厚さは５０〜８００μｍであり、孔隙率は１０〜８０％であり、コーティングの粘着強度は２５ＭＰａ以上である。 Here, a Ti coating is sprayed on the surface of the femoral stem proximal portion 4, the thickness of the Ti coating is 50 to 800 μm, the porosity is 10 to 80%, and the adhesive strength of the coating is It is 25 MPa or more.

本発明のプロテーゼは一体型を採用しており、コンポーネントの組み立てが必要なく、コンポーネント間の磨耗と骨腐食等の問題を解消し、在庫量を減らし、コストを削減し、あらゆる規模のメーカーに適用できる。本発明の大腿ステムデザインは、患者の大腿骨の骨髄腔の幾何学的形状に使用する大腿ステムに９０％以上合致する。本発明の前傾角度は０°または１５°または３５°であり、手術中の患者は自身の前傾角度に基づき、適切な規格のプロテーゼを選択でき、手術時間を短縮し、患者の痛みを減らし、手術の成功率を高める。本発明の大腿ステム近位部４の外表面にはＴｉコーティングを吹き付けており、プロテーゼの生体適合性を強化し強度とプラスチックの靭性は人体骨と相互にマッチングしており、骨細胞および軟部組織の成長、増殖に良好な条件を整える。これにより、プロテーゼと患者の大腿骨との完全なマッチングを実現し、特に発育性股関節形成不全（ＤＤＨ）、先天性股関節脱臼（ＣＤＨ）患者に適合する。 The prosthesis of the present invention adopts an integral type, eliminates the need for assembly of components, eliminates problems such as wear and bone corrosion between components, reduces inventory quantity, reduces cost, and is applicable to manufacturers of all sizes it can. The femoral stem design of the present invention is more than 90% compatible with the femoral stem used in the bone marrow cavity geometry of the patient's femur. The anteversion angle of the present invention is 0°, 15° or 35°, and the patient during surgery can select a prosthesis of appropriate standard based on his anteversion angle, which shortens the operation time and reduces the patient's pain. Reduce and increase the success rate of surgery. The outer surface of the femoral stem proximal portion 4 of the present invention is sprayed with a Ti coating to enhance the biocompatibility of the prosthesis and the strength and the toughness of the plastic mutually match with the human body bone. Establish good conditions for growth and proliferation. This provides a perfect match between the prosthesis and the patient's femur and is particularly suited to patients with developing hip dysplasia (DDH) and congenital hip dislocation (CDH).

本発明の好ましい実施形態について記述したが、当業者は、本発明の基本的な技術思想を把握した上、変更と変形を行える。そのような全ての変形と変更は本発明の保護範囲内にある。 Although the preferred embodiments of the present invention have been described, those skilled in the art can make changes and modifications after understanding the basic technical concept of the present invention. All such variations and modifications are within the protection scope of the present invention.

Claims (3)

大腿ステムプロテーゼは、順番に連結した大腿ステムコーンと、大腿骨頚部と、ステムを含み、前記ステムは、大腿ステム近位部と、大腿ステム中位部と、大腿ステム遠位部とを含み、前記大腿ステムコーンは円錐形をしており、前記大腿骨頚部の一端と大腿ステム近位部は連結しており、両者の間に偏角を備え、前記大腿骨頚部の別の一端は大腿ステムコーンの大径端部と連結しており、前記大腿ステム近位部の表面には多数の環状の微細溝を設置しており、前記大腿ステム遠位部の外表面に複数の縦に伸びた縦向きリッジを設置しており、
前記環状微細溝の幅は１．０〜１．５ｍｍ、深さは０．４〜０．５ｍｍであり、
前記大腿ステム近位部の外表面には、Ｔｉコーティングを吹き付けており、孔隙率は１０〜８０％であり、コーティングの粘着強度は２５ＭＰａ以上であり、前記Ｔｉコーティングの厚さは５０〜８００μｍであり、
前記大腿ステム遠位部の外表面に４〜１０本の縦向きリッジを設置しており、前記縦向きリッジの高さは０．５５〜０．６５ｍｍであり、
前記大腿ステム近位部の軸線と前記大腿骨頚部の軸線との間の角度は３５°であることを特徴とする大腿ステムプロテーゼ。 The femoral stem prosthesis includes a sequentially connected femoral stem cone, a femoral neck, and a stem, the stem including a femoral stem proximal portion, a femoral stem medial portion, and a femoral stem distal portion, The femoral stem cone has a conical shape, one end of the femoral neck and a proximal portion of the femoral stem are connected to each other, and a declination angle is provided between the femoral stem cone and the femoral stem. It is connected to the large-diameter end of the cone and has a large number of annular microgrooves on the surface of the proximal part of the femoral stem, and has a plurality of longitudinally extending outer surfaces of the distal part of the femoral stem. It has a vertical ridge,
The annular fine groove has a width of 1.0 to 1.5 mm and a depth of 0.4 to 0.5 mm,
A Ti coating is sprayed on the outer surface of the proximal part of the femoral stem, the porosity is 10 to 80%, the adhesive strength of the coating is 25 MPa or more, and the thickness of the Ti coating is 50 to 800 μm. Yes,
4 to 10 vertical ridges are provided on the outer surface of the distal portion of the femoral stem, and the height of the vertical ridges is 0.55 to 0.65 mm,
The femoral stem prosthesis, wherein the angle between the axis of the proximal femoral stem and the axis of the femoral neck is 35° . 前記ステム中心線と大腿骨頚部中心線との間に１２０°〜１４０°の夾角をなすことを特徴とする請求項１に記載の大腿ステムプロテーゼ。 The femoral stem prosthesis according to claim 1, wherein an included angle of 120° to 140° is formed between the stem center line and the femoral neck center line. 前記大腿骨頚部の横断面は楕円形であることを特徴とする請求項１に記載の大腿ステムプロテーゼ。 The femoral stem prosthesis according to claim 1, wherein a cross section of the femoral neck is oval.
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