WO2022153992A1 - Femoral stem and artificial hip joint system - Google Patents

Femoral stem and artificial hip joint system Download PDF

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Publication number
WO2022153992A1
WO2022153992A1 PCT/JP2022/000649 JP2022000649W WO2022153992A1 WO 2022153992 A1 WO2022153992 A1 WO 2022153992A1 JP 2022000649 W JP2022000649 W JP 2022000649W WO 2022153992 A1 WO2022153992 A1 WO 2022153992A1
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Prior art keywords
stem
inserter
tip
spherical
femur
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PCT/JP2022/000649
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French (fr)
Japanese (ja)
Inventor
友亮 中村
正典 佐藤
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ニプロ株式会社
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Priority to JP2022575593A priority Critical patent/JPWO2022153992A1/ja
Publication of WO2022153992A1 publication Critical patent/WO2022153992A1/en

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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

Definitions

  • the present invention relates to a femoral stem of an artificial hip joint and an artificial hip joint system including a femoral stem and a stem inserter that inserts the femoral stem into the femur.
  • total hip arthroplasty has been performed to replace the hip joint with an artificial one in order to restore the function of the hip joint whose function has deteriorated due to a disease or an accident.
  • Document 1 discloses a configuration in which the inclination of the stem inserter in the medial-lateral direction at the time of insertion can be adjusted.
  • the femoral stem and the artificial hip joint system disclosed in Patent Document 1 have an inner wall portion and a posterior wall portion of a recess formed in the shoulder portion of the femoral stem in order to make the rotation angle of the stem inserter adjustable. All of them have a flat region, and there is a problem that the contact area between the femoral stem and the stem inserter becomes small.
  • an object of the present invention is to provide a femoral stem and an artificial hip joint system capable of increasing the contact area between the femoral stem and the stem inserter while making it possible to adjust the rotation angle of the stem inserter. ..
  • the first aspect of the present invention is a femoral stem of an artificial hip joint.
  • the body that is inserted into the medullary cavity of the femur, Has a neck part to which the stem head is attached,
  • a recess is formed in the shoulder portion of the main body portion to accommodate the tip portion of the stem inserter.
  • the recess has a spherical portion that comes into contact with the tip end portion of the stem inserter, and a key groove that extends inward from the spherical portion and regulates the rotation of the stem inserter.
  • the contact area between the femoral stem and the stem inserter is increased by providing a spherical portion that contacts the tip of the stem inserter while allowing the rotation angle of the femoral stem to be adjusted by the keyway.
  • the durability of the stem inserter and the insertability of the femoral stem can be improved.
  • the first aspect further preferably has the following configuration.
  • the spherical surface portion comes into contact with the tip end portion of the stem inserter on an arc surface.
  • the key groove extends inward from the inner tip of the spherical surface portion.
  • the length in the inner-outer direction of the key groove is shorter than the diameter of the spherical surface portion.
  • the width of the key groove is shorter than the diameter of the spherical surface portion.
  • the contact area between the spherical surface portion and the tip portion can be easily increased by bringing the spherical surface portion and the tip portion of the stem inserter into contact with each other on an arc surface.
  • the recess is located on the outside of the shoulder and the recess is arranged on the central axis of the femoral stem. Can be done.
  • the holding property of the stem inserter by the spherical surface portion can be improved.
  • the rotation of the stem inserter by the keyway can be easily regulated.
  • a second aspect of the present invention is an artificial hip joint system.
  • the femoral stem of the first aspect and A stem inserter for inserting the femoral stem into the medullary cavity of the femur is provided.
  • the stem inserter includes a spherical tip portion that contacts the spherical surface portion and a key portion that engages with the key groove.
  • an artificial hip joint system capable of improving the durability of the stem inserter and the insertability of the femoral stem while making the rotation angle of the femoral stem adjustable.
  • the second aspect is further preferably provided with the following configuration.
  • the key portion is formed so as to project outward from the tip portion.
  • the tip of the key portion has an arc shape when viewed from the side.
  • the key portion of the stem inserter can be easily engaged with the key groove of the concave portion of the femoral stem.
  • the inclination of the stem inserter in the medial-lateral direction can be easily adjusted.
  • the contact area between the spherical surface portion and the tip portion can be easily increased by bringing the spherical surface portion and the tip portion of the stem inserter into contact with each other on an arc surface.
  • a femoral stem and an artificial hip joint system capable of increasing the contact area between the femoral stem and the stem inserter while making the rotation angle of the stem inserter adjustable.
  • FIG. 1 is a schematic view of FIG. 1 as viewed from the direction III. It is a partially enlarged view of FIG. It is a perspective view of a shoulder part. It is a top view of the shoulder part. It is a side view of a shoulder part. It is a partial perspective view of a stem inserter. It is a partial side view of the stem inserter. It is an X arrow view of the stem inserter of FIG. It is a perspective view which shows that the stem inserter is engaged with a femoral stem. It is a perspective view which shows adjusting the inclination in the medial-lateral direction of a stem inserter after engaging a stem inserter with a femoral stem.
  • FIG. 1 is a schematic view of the artificial hip joint system 10 according to the embodiment of the present invention as viewed from the front side
  • FIG. 2 is a partially enlarged view of FIG.
  • FIG. 3 is a schematic view of FIG. 1 as viewed from the direction III (outside)
  • FIG. 4 is a partially enlarged view of FIG.
  • FIGS. 1 to 4 show a diagram in which the artificial hip joint system 10 is applied to the left foot, the artificial hip joint system 10 of the present invention can also be applied to the right foot.
  • the position closer to the head of the human body than the comparison target is referred to as the proximal side, and the comparison target is compared with the human body.
  • the side far from the head is called the distal side.
  • the position closer to the center line of the human body than the comparison target is called the inside, and the position is located farther from the center line of the human body compared to the comparison target. What you are doing is called the outside.
  • the direction in which the face of the human body is facing is referred to as the front
  • the direction in which the back of the human body is facing is referred to as the rear.
  • the artificial hip joint system 10 includes a femur stem 1 and a stem inserter 2 that inserts the femur stem 1 into the medullary cavity 101 of the femur 100.
  • the femur stem 1 has a main body portion 11 inserted into the medullary space 101 of the femur 100, and a neck portion 12 attached to the acetabulum via a stem head and an acetabular component.
  • the femoral stem 1 has a curved substantially rod-like shape, and the length of the femoral stem 1 from the shoulder to the distal end on the stem central axis is, for example, 90 to 200 mm.
  • Titanium alloy, pure titanium, cobalt-chromium alloy, stainless steel, etc. are used as the base material of the femoral stem 1, and pure titanium, titanium alloy, hydroxyapatite, phosphorus, etc. are used as coating materials on the surface in contact with the pulp cavity 101. Calcium hydrogen acid and the like are used.
  • the length of the inner surface of the proximal portion 11a of the main body 11 is longer than the length of the outer surface. Further, the length of the outer surface of the distal portion 11b of the main body 11 is substantially equal to the length of the inner surface.
  • the stem central axis S1 of the femoral stem 1 is defined by the bisector of the angle formed by the inner and outer surfaces of the distal portion 11b in the anterior view.
  • the proximal portion 11a has a shoulder portion 13 on the proximal end side and the outer side.
  • 5 is a perspective view of the shoulder portion 13
  • FIG. 6 is a top view of the shoulder portion 13
  • FIG. 7 is a side view of the shoulder portion 13.
  • the shoulder portion 13 is formed with a recess 14 in which the tip portion 21 of the stem inserter 2 is housed.
  • the recess 14 has a spherical portion 15 that comes into contact with the tip portion 21 of the stem inserter 2, and a key groove 16 that extends inward from the inner tip of the spherical portion 15 and regulates the rotation of the stem inserter 2. is doing.
  • a part of the recess 14 is located on the stem central axis S1.
  • the recess 14 has a screw hole 14a at the distal end.
  • the screw hole 14a can be screw-fixed to the screw portion located at the tip of the stem remover when the femur stem 1 is removed for some reason after the femur stem 1 is inserted into the medullary cavity 101.
  • the key groove 16 has an arc shape when viewed from the side, and the length L1 and the width W1 (length in the front-rear direction) in the inner-outer direction of the key groove 16 are shorter than the diameter R1 of the spherical portion 15.
  • the width W1 of the key groove 16 is about 1.0 mm to 6.0 mm, preferably about 2.0 mm to 5.0 mm.
  • the effective depth D1 of the key groove 16 (distance from the tip center O1 of the tip 21 to the bottom surface of the key groove 16) is about 5.0 mm to 10.0 mm when the radius of the tip 21 is 4.5 mm. It is preferably about 5.5 mm to 8.5 mm.
  • the substantial depth D2 (distance from the spherical surface portion 15 to the bottom surface of the key groove 16) of the key groove 16 is about 0.5 mm to 5.5 mm when the radius of the tip portion 21 is 4.5 mm, and is preferably 1. It is about 0.0 mm to 4.0 mm.
  • FIG. 8 is a partial perspective view of the stem inserter 2
  • FIG. 9 is a partial side view of the stem inserter 2
  • FIG. 10 is an X arrow view of the stem inserter 2 of FIG.
  • FIG. 11 is a perspective view showing that the stem inserter 2 is engaged with the femur stem 1
  • FIG. 12 is a perspective view showing that the stem inserter 2 is engaged with the femur stem 1 and then the stem inserter. It is a perspective view which shows that the inclination in the inside-out direction of 2 is adjusted.
  • the stem inserter 2 includes a spherical tip portion 21 that contacts the spherical portion 15 and a key portion 22 that engages with the key groove 16.
  • At least a part of the tip portion 21 is accommodated in the spherical portion 15, and has a shape corresponding to the spherical portion 15. Further, at least a part of the key portion 22 is accommodated in the key groove 16, and has a shape corresponding to the key groove 16.
  • the tip portion 21 and the key portion 22 are integrally molded and are made of a material such as stainless steel that can withstand the sterilization process of surgical instruments such as high-pressure steam sterilization.
  • the key portion 22 is formed so as to project outward from the tip portion 21 inward from the tip portion 21.
  • the key portion 22 is formed over substantially the entire vertical direction of the tip portion 21, and the vertical length 22L of the key portion 22 is slightly shorter than the vertical length of the tip portion 21. More specifically, the lower end 22D of the key portion 22 is located above the lower end of the tip portion 21.
  • the key portion 22 has a substantially square shape when viewed from above, and has an arc shape at the tip when viewed from the side.
  • the upper end 22U of the tip of the key portion 22 is located inward with respect to the lower end 22D of the tip.
  • the tip portion 21 of the stem inserter 2 comes into contact with the spherical portion 15 on the arc surface 15a.
  • the arcuate surface 15a is the upper edge surface of the spherical surface portion 15, and has a substantially C shape because the inside is notched by the key groove 16.
  • the stem inserter 2 can be tilted in the directions of arrows A1 and A2 about the center O1 of the tip portion.
  • the stem inserter 2 is freely tilted in the directions of arrows A1 and A2 with the tip center O1 as the center, and the femur stem 1 is inserted from various angles.
  • the inclination angle ⁇ of the stem inserter 2 is an angle formed by the rotation axis O2 of the stem inserter 2 and the reference line S2.
  • the reference line S2 is a line that passes through the tip center O1 and is parallel to the stem center axis S1.
  • the inclination angle ⁇ of the stem inserter if the angle outside the reference line S2 is defined as positive and the angle inside the reference line S2 is defined as minus, in the present embodiment, the inclination angle ⁇ of the stem inserter 2 is defined as minus. Is in the range of maximum plus 49 degrees to minus 66 degrees.
  • the femur stem 1 can be inserted while controlling the insertion angle by inclining the stem inserter 2.
  • the key portion 22 engages with the key groove 16, when the stem inserter 2 is rotated in the directions of arrows B1 and B2 about the inserter rotation axis, the key portion 22 rotates with respect to the key groove 16. Is regulated. Therefore, the femoral stem 1 can be rotated in the directions of arrows b1 and b2. As a result, the femoral stem 1 can be inserted while adjusting the rotation angle of the femoral stem 1. The key portion 22 comes into contact with the key groove 16 when the stem inserter 2 is rotated, but the key portion 22 does not come into contact with the bottom surface of the key groove 16.
  • the spherical portion 15 that comes into contact with the tip 21 of the stem inserter 2 while the rotation angle of the femoral stem 1 can be adjusted by the key groove 16.
  • the contact area between the femoral stem 1 and the stem inserter 2 can be increased, and the durability of the stem inserter 2 and the insertability of the femoral stem 1 can be improved.
  • the key groove 16 extends inward from the inner tip of the spherical portion 15, the recess 14 can be positioned on the stem central axis S1. As a result, the force when inserting the femoral stem 1 can be easily applied to the femoral stem 1.
  • the artificial hip joint system 10 includes a femur stem 1 and a stem inserter 2 for inserting the femur stem 1 into the medullary space 101 of the femur 100, and the stem inserter 2 is a femur stem 1. Since the spherical tip portion 21 that contacts the spherical portion 15 and the key portion 22 that engages with the key groove 16 of the femur stem 1 are provided, the rotation angle of the femur stem 1 can be adjusted while the stem is inserted. The durability of the sirter 2 can be improved.
  • the key portion 22 of the stem inserter 2 is formed so as to project outward from the tip portion, the key portion 22 of the stem inserter 2 is inserted into the key groove 16 of the recess 14 of the femur stem 1. Can be easily engaged.
  • the inclination angle of the stem inserter 2 can be increased.
  • the width W1 (length in the anteroposterior direction) of the key groove 16 is defined within a predetermined range of about 1.0 mm to 6.0 mm, the key portion 22 of the stem inserter 2 and the femur stem 1
  • the durability of the main body 11 can be improved. If the width W1 of the key groove 16 is too small, the key portion 22 of the stem inserter 2 becomes thin, and there is a concern that the durability of the key portion 22 may decrease. Further, if the width W1 of the key groove 16 is too large, the engraving of the key groove 16 becomes large, and there is a concern that the durability of the main body portion 11 may decrease.
  • the effective depth D1 of the key groove 16 (distance from the tip center O1 of the tip 21 to the bottom surface of the key groove 16) is 5.0 mm to 10.0 mm when the radius of the tip 21 is 4.5 mm. Since the degree is specified, the rotational property of the femur stem 1 by the stem inserter 2 can be ensured, and the durability of the main body 11 of the femur stem 1 can be improved. If the effective depth D1 of the keyway 16 is too shallow, there is a concern that it will be difficult for the stem inserter 2 to rotate the femoral stem 1. Further, if the effective depth D1 of the key groove 16 is too deep, the engraving of the key groove 16 becomes large, and there is a concern that the durability of the main body portion 11 may decrease.
  • the actual depth D2 of the key groove 16 (distance from the spherical surface portion 15 to the bottom surface of the key groove 16) is defined to be about 0.5 mm to 5.5 mm when the radius of the tip portion 21 is 4.5 mm. Therefore, the rotational property of the femoral stem 1 by the stem inserter 2 can be ensured, and the durability of the main body portion 11 can be improved. If the substantial depth D2 of the keyway 16 is too shallow, there is a concern that it will be difficult for the stem inserter 2 to rotate the femoral stem 1. Further, if the actual depth D2 of the key groove 16 is too deep, the engraving of the key groove 16 becomes large, and there is a concern that the durability of the main body portion 11 may decrease.
  • the recess 14 of the femur stem 1 has a screw hole 14a at the distal end. Therefore, for the femur stem 1, a stem remover having a threaded portion at the tip can be used, and the femur stem 1 can be extracted from the medullary cavity 101 of the femur 100.
  • the key portion 22 Since the key portion 22 has a shape that does not contact the bottom surface of the key groove 16, the key portion 22 is inserted when the femur stem 1 is inserted by hitting the stem inserter 2 with another tool (hammer) or the like. It is possible to reduce the load on the stem.
  • one key groove 16 is formed so as to extend inward from the inner tip of the spherical surface portion 15, but a plurality of key grooves 16 may be formed. Even in that case, in order to bring the recess 14 closer to the stem central axis S1, it is preferable that all of the plurality of keyways extend inward from the inner edge of the spherical portion 15.
  • the femur stem 1 and the artificial hip joint system 10 capable of increasing the contact area between the femur stem 1 and the stem inserter 2 while making the rotation angle of the stem inserter 2 adjustable. It has great industrial utility value.

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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)
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Abstract

This femoral stem (1) of an artificial hip joint includes a main body (11) to be inserted into a medullary cavity (101) of a femur (100), and a neck section (12) to which a stem head is attached. A recess (14) in which the tip (21) of a stem inserter (2) is stored is provided in the shoulder section (13) of the main body (11). The recess (14) includes a spherical surface section (15) in contact with the tip (21) of the stem inserter (2), and a key groove (16) extending from the spherical surface section (15) to the inner side and regulating the turning of the stem inserter (2).

Description

大腿骨ステム及び人工股関節システムFemoral stem and hip prosthesis system
　本発明は、人工股関節の大腿骨ステム、及び、大腿骨ステム及び大腿骨ステムを大腿骨に挿入するステムインサーターを含む人工股関節システムに関する。 The present invention relates to a femoral stem of an artificial hip joint and an artificial hip joint system including a femoral stem and a stem inserter that inserts the femoral stem into the femur.
　従来から、疾患又は事故等で機能が低下した股関節の機能を回復させるために、股関節を人工のものに置換する人工股関節置換術が行われている。 Conventionally, total hip arthroplasty has been performed to replace the hip joint with an artificial one in order to restore the function of the hip joint whose function has deteriorated due to a disease or an accident.
　ここで、人工股関節置換術では、人工股関節を構成する部材のうち、人工の大腿骨ステムを人体の大腿骨の髄腔に挿入することが行われるが、その挿入性を向上させるために、特許文献１では、挿入時におけるステムインサーターの内外側方向の傾斜を調整可能とする構成が開示されている。 Here, in total hip arthroplasty, an artificial femur stem is inserted into the medullary space of the femur of the human body among the members constituting the artificial hip joint. Document 1 discloses a configuration in which the inclination of the stem inserter in the medial-lateral direction at the time of insertion can be adjusted.
国際公開第２０１５／０９８７２９号International Publication No. 2015/0987729
　しかし、特許文献１に開示された大腿骨ステム及び人工股関節システムは、ステムインサーターの回旋角度を調整可能とするために、大腿骨ステムの肩部に形成された凹部の内壁部及び後壁部がいずれも平坦状の領域を有するようになっており、大腿骨ステムとステムインサーターとの接触面積が小さくなるという課題が存在する。 However, the femoral stem and the artificial hip joint system disclosed in Patent Document 1 have an inner wall portion and a posterior wall portion of a recess formed in the shoulder portion of the femoral stem in order to make the rotation angle of the stem inserter adjustable. All of them have a flat region, and there is a problem that the contact area between the femoral stem and the stem inserter becomes small.
　そこで、本発明では、ステムインサーターの回旋角度を調整可能としながら、大腿骨ステムとステムインサーターとの接触面積を増加させることができる大腿骨ステム及び人工股関節システムを提供することを目的とする。 Therefore, an object of the present invention is to provide a femoral stem and an artificial hip joint system capable of increasing the contact area between the femoral stem and the stem inserter while making it possible to adjust the rotation angle of the stem inserter. ..
　本発明の第１態様は、人工股関節の大腿骨ステムであって、
　大腿骨の髄腔に挿入される本体部と、
　ステムヘッドが取り付けられるネック部と、を有し、
　前記本体部の肩部には、ステムインサーターの先端部が収容される凹部が形成されており、
　前記凹部は、前記ステムインサーターの先端部と接触する球面部と、前記球面部から内側に向かって延び、前記ステムインサーターの回動を規制するキー溝と、を有している。 The first aspect of the present invention is a femoral stem of an artificial hip joint.
The body that is inserted into the medullary cavity of the femur,
Has a neck part to which the stem head is attached,
A recess is formed in the shoulder portion of the main body portion to accommodate the tip portion of the stem inserter.
The recess has a spherical portion that comes into contact with the tip end portion of the stem inserter, and a key groove that extends inward from the spherical portion and regulates the rotation of the stem inserter.
　前記構成によれば、キー溝で大腿骨ステムの回旋角度を調整可能としながら、ステムインサーターの先端部と接触する球面部を設けることによって、大腿骨ステムとステムインサーターとの接触面積を増加させ、ステムインサーターの耐久性及び大腿骨ステムの挿入性を向上させることができる。 According to the above configuration, the contact area between the femoral stem and the stem inserter is increased by providing a spherical portion that contacts the tip of the stem inserter while allowing the rotation angle of the femoral stem to be adjusted by the keyway. The durability of the stem inserter and the insertability of the femoral stem can be improved.
　第１態様は、さらに、次のような構成を備えるのが好ましい。 The first aspect further preferably has the following configuration.
（１）前記球面部は、前記ステムインサーターの先端部と円弧面で接触するようになっている。 (1) The spherical surface portion comes into contact with the tip end portion of the stem inserter on an arc surface.
（２）前記キー溝は、前記球面部の内側先端から内側に向かって延びている。 (2) The key groove extends inward from the inner tip of the spherical surface portion.
（３）前記キー溝の内外側方向長さは、前記球面部の径よりも短くなっている。 (3) The length in the inner-outer direction of the key groove is shorter than the diameter of the spherical surface portion.
（４）前記キー溝の幅は、前記球面部の径よりも短くなっている。 (4) The width of the key groove is shorter than the diameter of the spherical surface portion.
　前記構成（１）によれば、球面部とステムインサーターの先端部とを円弧面で接触させることによって、球面部と先端部の接触面積を容易に増加させることができる。 According to the configuration (1), the contact area between the spherical surface portion and the tip portion can be easily increased by bringing the spherical surface portion and the tip portion of the stem inserter into contact with each other on an arc surface.
　前記構成（２）によれば、キー溝が球面部の内側先端から内側に向かって延びているので、凹部を肩部の外側に位置させ、凹部を大腿骨ステムの中心軸上に配置することができる。 According to the configuration (2), since the keyway extends inward from the medial tip of the spherical portion, the recess is located on the outside of the shoulder and the recess is arranged on the central axis of the femoral stem. Can be done.
　前記構成（３）によれば、球面部によるステムインサーターの保持性を向上させることができる。 According to the configuration (3), the holding property of the stem inserter by the spherical surface portion can be improved.
　前記構成（４）によれば、キー溝によるステムインサーターの回動の規制を容易に行うことができる。 According to the configuration (4), the rotation of the stem inserter by the keyway can be easily regulated.
　本発明の第２態様は、人工股関節システムであって、
　第１態様の大腿骨ステムと、
　前記大腿骨ステムを大腿骨の髄腔に挿入するステムインサーターと、を備え、
　前記ステムインサーターは、前記球面部に接触する球体状の先端部と、前記キー溝に係合するキー部を備えている。 A second aspect of the present invention is an artificial hip joint system.
The femoral stem of the first aspect and
A stem inserter for inserting the femoral stem into the medullary cavity of the femur is provided.
The stem inserter includes a spherical tip portion that contacts the spherical surface portion and a key portion that engages with the key groove.
　前記構成によれば、大腿骨ステムの回旋角度を調整可能としながら、ステムインサーターの耐久性及び大腿骨ステムの挿入性を向上させることができる、人工股関節システムを提供できる。 According to the above configuration, it is possible to provide an artificial hip joint system capable of improving the durability of the stem inserter and the insertability of the femoral stem while making the rotation angle of the femoral stem adjustable.
　第２態様は、さらに、次のような構成を備えるのが好ましい。 The second aspect is further preferably provided with the following configuration.
（１）前記キー部は、前記先端部から外方に突出するように形成されている。 (1) The key portion is formed so as to project outward from the tip portion.
（２）前記キー部の先端は、側面視で円弧形状を有している。 (2) The tip of the key portion has an arc shape when viewed from the side.
（３）前記ステムインサーターの先端部は、前記球面部に対して円弧面で接触するようになっている。 (3) The tip end portion of the stem inserter comes into contact with the spherical surface portion on an arc surface.
　前記構成（１）によれば、ステムインサーターのキー部を大腿骨ステムの凹部のキー溝に容易に係合させることができる。 According to the configuration (1), the key portion of the stem inserter can be easily engaged with the key groove of the concave portion of the femoral stem.
　前記構成（２）によれば、ステムインサーターの内外側方向の傾斜を容易に調整することができる。 According to the configuration (2), the inclination of the stem inserter in the medial-lateral direction can be easily adjusted.
　前記構成（３）によれば、球面部とステムインサーターの先端部とを円弧面で接触させることによって、球面部と先端部の接触面積を容易に増加させることができる。 According to the configuration (3), the contact area between the spherical surface portion and the tip portion can be easily increased by bringing the spherical surface portion and the tip portion of the stem inserter into contact with each other on an arc surface.
　要するに、本発明によると、ステムインサーターの回旋角度を調整可能としながら、大腿骨ステムとステムインサーターとの接触面積を増加させることができる大腿骨ステム及び人工股関節システムを提供することができる。 In short, according to the present invention, it is possible to provide a femoral stem and an artificial hip joint system capable of increasing the contact area between the femoral stem and the stem inserter while making the rotation angle of the stem inserter adjustable.
本発明の実施形態に係る人工股関節システムの正面側から見た概略図である。It is the schematic seen from the front side of the artificial hip joint system which concerns on embodiment of this invention. 図１の部分拡大図である。It is a partially enlarged view of FIG. 図１をIII方向から見た概略図である。FIG. 1 is a schematic view of FIG. 1 as viewed from the direction III. 図３の部分拡大図である。It is a partially enlarged view of FIG. 肩部の斜視図である。It is a perspective view of a shoulder part. 肩部の上面図である。It is a top view of the shoulder part. 肩部の側面図である。It is a side view of a shoulder part. ステムインサーターの部分斜視図である。It is a partial perspective view of a stem inserter. ステムインサーターの部分側面図である。It is a partial side view of the stem inserter. 図９のステムインサーターのＸ矢視図である。It is an X arrow view of the stem inserter of FIG. ステムインサーターを大腿骨ステムに係合させることを示す斜視図である。It is a perspective view which shows that the stem inserter is engaged with a femoral stem. ステムインサーターを大腿骨ステムに係合させた後、ステムインサーターの内外側方向の傾斜を調整することを示す斜視図である。It is a perspective view which shows adjusting the inclination in the medial-lateral direction of a stem inserter after engaging a stem inserter with a femoral stem.
　図１は、本発明の実施形態に係る人工股関節システム１０の正面側から見た概略図であり、図２は、図１の部分拡大図である。また、図３は、図１をIII方向（外側）から見た概略図であり、図４は、図３の部分拡大図である。なお、ここでは、図１～図４は、人工股関節システム１０を左足に適用する図を示しているが、本発明の人工股関節システム１０は、右足に適用することもできる。 FIG. 1 is a schematic view of the artificial hip joint system 10 according to the embodiment of the present invention as viewed from the front side, and FIG. 2 is a partially enlarged view of FIG. Further, FIG. 3 is a schematic view of FIG. 1 as viewed from the direction III (outside), and FIG. 4 is a partially enlarged view of FIG. Although FIGS. 1 to 4 show a diagram in which the artificial hip joint system 10 is applied to the left foot, the artificial hip joint system 10 of the present invention can also be applied to the right foot.
　以下、説明の都合上、人工股関節システム１０を人体に取り付けたとき、比較対象と比べて人体の頭部に近い側に位置していることを近位側といい、比較対象を比べて人体の頭部から遠い側に位置していることを遠位側という。また、人工股関節システム１０を人体に取り付けたとき、比較対象と比べて人体の中心線に近い側に位置していることを内側といい、比較対象を比べて人体の中心線から遠い側に位置していることを外側という。そして、人工股関節システム１０を人体に取り付けたとき、人体の顔が向いている方向を前方といい、人体の背部が向いている方向を後方という。 Hereinafter, for convenience of explanation, when the artificial hip joint system 10 is attached to the human body, the position closer to the head of the human body than the comparison target is referred to as the proximal side, and the comparison target is compared with the human body. The side far from the head is called the distal side. Further, when the artificial hip joint system 10 is attached to the human body, the position closer to the center line of the human body than the comparison target is called the inside, and the position is located farther from the center line of the human body compared to the comparison target. What you are doing is called the outside. When the artificial hip joint system 10 is attached to the human body, the direction in which the face of the human body is facing is referred to as the front, and the direction in which the back of the human body is facing is referred to as the rear.
　図１～図４に示されるように、人工股関節システム１０は、大腿骨ステム１と、大腿骨ステム１を大腿骨１００の髄腔１０１に挿入するステムインサーター２と、を備えている。 As shown in FIGS. 1 to 4, the artificial hip joint system 10 includes a femur stem 1 and a stem inserter 2 that inserts the femur stem 1 into the medullary cavity 101 of the femur 100.
　大腿骨ステム１は、大腿骨１００の髄腔１０１に挿入される本体部１１と、ステムヘッド及び寛骨臼コンポーネントを介して臼蓋に取り付けられるネック部１２と、を有している。大腿骨ステム１は、湾曲した略棒状の形状を有しており、大腿骨ステム１のステム中心軸上における肩部から遠位端までの長さは、例えば、９０～２００ｍｍである。 The femur stem 1 has a main body portion 11 inserted into the medullary space 101 of the femur 100, and a neck portion 12 attached to the acetabulum via a stem head and an acetabular component. The femoral stem 1 has a curved substantially rod-like shape, and the length of the femoral stem 1 from the shoulder to the distal end on the stem central axis is, for example, 90 to 200 mm.
　大腿骨ステム１の母材には、チタン合金、純チタン、コバルトクロム合金、ステンレス等が使用され、髄腔１０１と接触する面には、コーティング材として、純チタン、チタン合金、ハイドロキシアパタイト、リン酸水素カルシウム等が使用されている。 Titanium alloy, pure titanium, cobalt-chromium alloy, stainless steel, etc. are used as the base material of the femoral stem 1, and pure titanium, titanium alloy, hydroxyapatite, phosphorus, etc. are used as coating materials on the surface in contact with the pulp cavity 101. Calcium hydrogen acid and the like are used.
　前面視において、本体部１１の近位部１１ａは、内側面の長さが外側面の長さより長くなっている。また、本体部１１の遠位部１１ｂは、外側面の長さが内側面の長さと略等しくなっている。そして、ここでは、大腿骨ステム１のステム中心軸Ｓ１は、前面視において、遠位部１１ｂの内側面及び外側面のなす角の二等分線で規定される。 In front view, the length of the inner surface of the proximal portion 11a of the main body 11 is longer than the length of the outer surface. Further, the length of the outer surface of the distal portion 11b of the main body 11 is substantially equal to the length of the inner surface. Here, the stem central axis S1 of the femoral stem 1 is defined by the bisector of the angle formed by the inner and outer surfaces of the distal portion 11b in the anterior view.
　近位部１１ａは、近位端側及び外側に肩部１３を有している。図５は、肩部１３の斜視図であり、図６は、肩部１３の上面図であり、図７は、肩部１３の側面図である。図５～図７に示されるように、肩部１３には、ステムインサーター２の先端部２１が収容される凹部１４が形成されている。 The proximal portion 11a has a shoulder portion 13 on the proximal end side and the outer side. 5 is a perspective view of the shoulder portion 13, FIG. 6 is a top view of the shoulder portion 13, and FIG. 7 is a side view of the shoulder portion 13. As shown in FIGS. 5 to 7, the shoulder portion 13 is formed with a recess 14 in which the tip portion 21 of the stem inserter 2 is housed.
　凹部１４は、ステムインサーター２の先端部２１と接触する球面部１５と、球面部１５の内側先端から内側に向かって延び、ステムインサーター２の回動を規制するキー溝１６と、を有している。そして、凹部１４の一部は、ステム中心軸Ｓ１上に位置するようになっている。 The recess 14 has a spherical portion 15 that comes into contact with the tip portion 21 of the stem inserter 2, and a key groove 16 that extends inward from the inner tip of the spherical portion 15 and regulates the rotation of the stem inserter 2. is doing. A part of the recess 14 is located on the stem central axis S1.
　凹部１４は、遠位端部にネジ穴１４ａを有している。ネジ穴１４ａは、大腿骨ステム１を髄腔１０１内に挿入後、何らかの理由で大腿骨ステム１を抜去する際、ステム抜去器の先端部に位置するネジ部とネジ固定可能となっている。 The recess 14 has a screw hole 14a at the distal end. The screw hole 14a can be screw-fixed to the screw portion located at the tip of the stem remover when the femur stem 1 is removed for some reason after the femur stem 1 is inserted into the medullary cavity 101.
　キー溝１６は、側面視で円弧形状を有しており、キー溝１６の内外側方向長さＬ１及び幅Ｗ１（前後方向長さ）は、球面部１５の径Ｒ１よりも短くなっている。 The key groove 16 has an arc shape when viewed from the side, and the length L1 and the width W1 (length in the front-rear direction) in the inner-outer direction of the key groove 16 are shorter than the diameter R1 of the spherical portion 15.
　キー溝１６の幅Ｗ１は、１．０ｍｍ～６．０ｍｍ程度であり、好ましくは、２．０ｍｍ～５．０ｍｍ程度である。 The width W1 of the key groove 16 is about 1.0 mm to 6.0 mm, preferably about 2.0 mm to 5.0 mm.
　キー溝１６の実効深さＤ１（先端部２１の先端部中心Ｏ１からキー溝１６底面までの距離）は、先端部２１の半径が４．５ｍｍの場合、５．０ｍｍ～１０．０ｍｍ程度であり、好ましくは、５．５ｍｍ～８．５ｍｍ程度である。 The effective depth D1 of the key groove 16 (distance from the tip center O1 of the tip 21 to the bottom surface of the key groove 16) is about 5.0 mm to 10.0 mm when the radius of the tip 21 is 4.5 mm. It is preferably about 5.5 mm to 8.5 mm.
　キー溝１６の実質深さＤ２（球面部１５からキー溝１６底面までの距離）は、先端部２１の半径が４．５ｍｍの場合、０．５ｍｍ～５．５ｍｍ程度であり、好ましくは、１．０ｍｍ～４．０ｍｍ程度である。 The substantial depth D2 (distance from the spherical surface portion 15 to the bottom surface of the key groove 16) of the key groove 16 is about 0.5 mm to 5.5 mm when the radius of the tip portion 21 is 4.5 mm, and is preferably 1. It is about 0.0 mm to 4.0 mm.
　図８は、ステムインサーター２の部分斜視図であり、図９は、ステムインサーター２の部分側面図であり、図１０は、図９のステムインサーター２のＸ矢視図である。そして、図１１は、ステムインサーター２を大腿骨ステム１に係合させることを示す斜視図であり、図１２は、ステムインサーター２を大腿骨ステム１に係合させた後、ステムインサーター２の内外側方向の傾斜を調整することを示す斜視図である。図８～図１２に示されるように、ステムインサーター２は、球面部１５に接触する球体状の先端部２１と、キー溝１６に係合するキー部２２と、を備えている。先端部２１は、少なくとも一部が球面部１５に収容されるようになっており、球面部１５に対応する形状を有している。また、キー部２２は、少なくとも一部がキー溝１６に収容されるようになっており、キー溝１６に対応する形状を有している。先端部２１及びキー部２２は、一体に成形されており、高圧蒸気滅菌等の手術用器械の滅菌処理に耐え得る、ステンレス等の材質でできている。 8 is a partial perspective view of the stem inserter 2, FIG. 9 is a partial side view of the stem inserter 2, and FIG. 10 is an X arrow view of the stem inserter 2 of FIG. FIG. 11 is a perspective view showing that the stem inserter 2 is engaged with the femur stem 1, and FIG. 12 is a perspective view showing that the stem inserter 2 is engaged with the femur stem 1 and then the stem inserter. It is a perspective view which shows that the inclination in the inside-out direction of 2 is adjusted. As shown in FIGS. 8 to 12, the stem inserter 2 includes a spherical tip portion 21 that contacts the spherical portion 15 and a key portion 22 that engages with the key groove 16. At least a part of the tip portion 21 is accommodated in the spherical portion 15, and has a shape corresponding to the spherical portion 15. Further, at least a part of the key portion 22 is accommodated in the key groove 16, and has a shape corresponding to the key groove 16. The tip portion 21 and the key portion 22 are integrally molded and are made of a material such as stainless steel that can withstand the sterilization process of surgical instruments such as high-pressure steam sterilization.
　キー部２２は、先端部２１から内側に向かって先端部２１の外方に突出するように形成されている。キー部２２は、先端部２１の上下方向略全体に亘って形成されており、キー部２２の上下方向長さ２２Ｌは、先端部２１の上下方向長さより少し短くなっている。より具体的には、キー部２２の下端２２Ｄは、先端部２１の下端より上方に位置している。 The key portion 22 is formed so as to project outward from the tip portion 21 inward from the tip portion 21. The key portion 22 is formed over substantially the entire vertical direction of the tip portion 21, and the vertical length 22L of the key portion 22 is slightly shorter than the vertical length of the tip portion 21. More specifically, the lower end 22D of the key portion 22 is located above the lower end of the tip portion 21.
　キー部２２は、上面視で略四角形状を有しており、側面視で先端が円弧形状を有している。そして、キー部２２の先端の上端２２Ｕは、先端の下端２２Ｄに比べて内方に位置している。 The key portion 22 has a substantially square shape when viewed from above, and has an arc shape at the tip when viewed from the side. The upper end 22U of the tip of the key portion 22 is located inward with respect to the lower end 22D of the tip.
　特に、図１１及び図１２に示されるように、ステムインサーター２の先端部２１は、球面部１５に対して円弧面１５ａで接触するようになっている。円弧面１５ａは、球面部１５の上縁面であり、キー溝１６で内側が切り欠かれているので、略Ｃ形状を有している。 In particular, as shown in FIGS. 11 and 12, the tip portion 21 of the stem inserter 2 comes into contact with the spherical portion 15 on the arc surface 15a. The arcuate surface 15a is the upper edge surface of the spherical surface portion 15, and has a substantially C shape because the inside is notched by the key groove 16.
　したがって、ステムインサーター２の先端部２１及びキー部２２が凹部１４に収容されると、ステムインサーター２が先端部中心Ｏ１を中心に矢印Ａ１、Ａ２方向に傾斜可能となる。その結果、大腿骨ステム１を大腿骨に挿入する際、先端部中心Ｏ１を中心に矢印Ａ１、Ａ２方向にステムインサーター２を自由に傾斜させて、様々な角度から大腿骨ステム１を挿入することが可能となる。ここで、ステムインサーター２の傾斜角度θは、ステムインサーター２の回旋軸Ｏ２と基準線Ｓ２とのなす角度である。基準線Ｓ２は、先端部中心Ｏ１を通りステム中心軸Ｓ１に平行な線である。 Therefore, when the tip portion 21 and the key portion 22 of the stem inserter 2 are housed in the recess 14, the stem inserter 2 can be tilted in the directions of arrows A1 and A2 about the center O1 of the tip portion. As a result, when the femur stem 1 is inserted into the femur, the stem inserter 2 is freely tilted in the directions of arrows A1 and A2 with the tip center O1 as the center, and the femur stem 1 is inserted from various angles. It becomes possible. Here, the inclination angle θ of the stem inserter 2 is an angle formed by the rotation axis O2 of the stem inserter 2 and the reference line S2. The reference line S2 is a line that passes through the tip center O1 and is parallel to the stem center axis S1.
　ステムインサーターの傾斜角度θは、基準線Ｓ２よりも外側の角度をプラスと規定し、基準線Ｓ２よりも内側の角度をマイナスと規定すると、本実施形態では、ステムインサーター２の傾斜角度θは、最大プラス４９度からマイナス６６度の範囲となる。 As for the inclination angle θ of the stem inserter, if the angle outside the reference line S2 is defined as positive and the angle inside the reference line S2 is defined as minus, in the present embodiment, the inclination angle θ of the stem inserter 2 is defined as minus. Is in the range of maximum plus 49 degrees to minus 66 degrees.
　また、大腿骨ステム１を挿入しているときに挿入角度が変化しても、ステムインサーター２を傾斜させることによって、挿入角度を制御しながら、大腿骨ステム１を挿入できる。 Further, even if the insertion angle changes while the femur stem 1 is being inserted, the femur stem 1 can be inserted while controlling the insertion angle by inclining the stem inserter 2.
　また、キー部２２がキー溝１６に係合するので、ステムインサーター２を、インサーター回旋軸を中心に矢印Ｂ１、Ｂ２方向に回旋させると、キー部２２がキー溝１６に対して回動することが規制される。したがって、大腿骨ステム１を矢印ｂ１、ｂ２方向に回旋させることができる。その結果、大腿骨ステム１の回旋角度を調整しながら、大腿骨ステム１を挿入することができる。なお、キー部２２は、ステムインサーター２を回旋させるとキー溝１６に接触するが、キー部２２はキー溝１６底面には接触しない形状となっている。 Further, since the key portion 22 engages with the key groove 16, when the stem inserter 2 is rotated in the directions of arrows B1 and B2 about the inserter rotation axis, the key portion 22 rotates with respect to the key groove 16. Is regulated. Therefore, the femoral stem 1 can be rotated in the directions of arrows b1 and b2. As a result, the femoral stem 1 can be inserted while adjusting the rotation angle of the femoral stem 1. The key portion 22 comes into contact with the key groove 16 when the stem inserter 2 is rotated, but the key portion 22 does not come into contact with the bottom surface of the key groove 16.
　前記構成の人工股関節システム１０によれば、次のような効果を発揮できる。 According to the artificial hip joint system 10 having the above configuration, the following effects can be exhibited.
（１）大腿骨ステム１の凹部１４にキー溝１６を設けることによって、キー溝１６で大腿骨ステム１の回旋角度を調整可能としながら、ステムインサーター２の先端部２１と接触する球面部１５を設けることによって、大腿骨ステム１とステムインサーター２との接触面積を増加させ、ステムインサーター２の耐久性及び大腿骨ステム１の挿入性を向上させることができる。 (1) By providing the key groove 16 in the recess 14 of the femoral stem 1, the spherical portion 15 that comes into contact with the tip 21 of the stem inserter 2 while the rotation angle of the femoral stem 1 can be adjusted by the key groove 16. By providing the stem inserter 2, the contact area between the femoral stem 1 and the stem inserter 2 can be increased, and the durability of the stem inserter 2 and the insertability of the femoral stem 1 can be improved.
（２）大腿骨ステム１の球面部１５は、ステムインサーター２の先端部２１と円弧面１５ａで接触するようになっているので、球面部１５と先端部２１の接触面積を容易に増加させることができる。 (2) Since the spherical portion 15 of the femur stem 1 comes into contact with the tip portion 21 of the stem inserter 2 at the arc surface 15a, the contact area between the spherical portion 15 and the tip portion 21 can be easily increased. be able to.
（３）キー溝１６は、球面部１５の内側先端から内側に向かって延びているので、凹部１４をステム中心軸Ｓ１上に位置させることができる。その結果、大腿骨ステム１を挿入するときの力が、大腿骨ステム１に加わり易くすることができる。 (3) Since the key groove 16 extends inward from the inner tip of the spherical portion 15, the recess 14 can be positioned on the stem central axis S1. As a result, the force when inserting the femoral stem 1 can be easily applied to the femoral stem 1.
（４）キー溝１６は、球面部１５の内側先端のみに形成されているので、凹部１４の一部は、ステム中心軸Ｓ１上に位置するようになっている。その結果、大腿骨ステム１を挿入するときの力が、大腿骨ステム１に加わり易くすることができる。 (4) Since the key groove 16 is formed only at the inner tip of the spherical surface portion 15, a part of the recess 14 is located on the stem central axis S1. As a result, the force when inserting the femoral stem 1 can be easily applied to the femoral stem 1.
（５）キー溝１６の内外側方向長さは、球面部１５の径よりも短くなっているので、球面部１５によるステムインサーター２の保持性を向上させることができる。 (5) Since the length of the key groove 16 in the inner-outer direction is shorter than the diameter of the spherical portion 15, the holding property of the stem inserter 2 by the spherical portion 15 can be improved.
（６）キー溝１６の幅は、球面部１５の径よりも短くなっているので、キー溝１６によるステムインサーター２の回動の規制を容易に行うことができる。 (6) Since the width of the key groove 16 is shorter than the diameter of the spherical surface portion 15, the rotation of the stem inserter 2 by the key groove 16 can be easily regulated.
（７）人工股関節システム１０は、大腿骨ステム１と、大腿骨ステム１を大腿骨１００の髄腔１０１に挿入するステムインサーター２と、を備え、ステムインサーター２は、大腿骨ステム１の球面部１５に接触する球体状の先端部２１と、大腿骨ステム１のキー溝１６に係合するキー部２２を備えているので、大腿骨ステム１の回旋角度を調整可能としながら、ステムインサーター２の耐久性を向上させることができる。 (7) The artificial hip joint system 10 includes a femur stem 1 and a stem inserter 2 for inserting the femur stem 1 into the medullary space 101 of the femur 100, and the stem inserter 2 is a femur stem 1. Since the spherical tip portion 21 that contacts the spherical portion 15 and the key portion 22 that engages with the key groove 16 of the femur stem 1 are provided, the rotation angle of the femur stem 1 can be adjusted while the stem is inserted. The durability of the sirter 2 can be improved.
（８）ステムインサーター２のキー部２２は、先端部から外方に突出するように形成されているので、ステムインサーター２のキー部２２を大腿骨ステム１の凹部１４のキー溝１６に容易に係合させることができる。 (8) Since the key portion 22 of the stem inserter 2 is formed so as to project outward from the tip portion, the key portion 22 of the stem inserter 2 is inserted into the key groove 16 of the recess 14 of the femur stem 1. Can be easily engaged.
（９）キー部２２の先端は、側面視で円弧形状を有しているので、ステムインサーター２の内外側方向の傾斜を容易に調整することができる。 (9) Since the tip of the key portion 22 has an arc shape when viewed from the side, the inclination of the stem inserter 2 in the medial-lateral direction can be easily adjusted.
（１０）キー部２２がキー溝１６に係合するので、ステムインサーター２を、インサーター回旋軸を中心に矢印Ｂ１、Ｂ２方向に回旋させると、キー部２２がキー溝１６に対して回動することが規制される。したがって、大腿骨ステム１を矢印ｂ１、ｂ２方向に回旋させることができる。その結果、大腿骨ステム１の回旋角度を調整しながら、大腿骨ステム１を挿入することができる。 (10) Since the key portion 22 engages with the key groove 16, when the stem inserter 2 is rotated in the directions of arrows B1 and B2 about the inserter rotation axis, the key portion 22 rotates with respect to the key groove 16. It is regulated to move. Therefore, the femoral stem 1 can be rotated in the directions of arrows b1 and b2. As a result, the femoral stem 1 can be inserted while adjusting the rotation angle of the femoral stem 1.
（１１）ステムインサーター２の先端部２１は、大腿骨ステム１の球面部１５に対して円弧面１５ａで接触するようになっているので、球面部１５と先端部２１の接触面積を容易に増加させることができる。 (11) Since the tip portion 21 of the stem inserter 2 comes into contact with the spherical portion 15 of the femur stem 1 on the arc surface 15a, the contact area between the spherical portion 15 and the tip portion 21 can be easily adjusted. Can be increased.
（１２）キー溝１６は、側面視で円弧形状を有しているので、ステムインサーター２の傾斜角度を大きくすることができる。 (12) Since the key groove 16 has an arc shape when viewed from the side, the inclination angle of the stem inserter 2 can be increased.
（１３）キー溝１６の幅Ｗ１（前後方向長さ）は、１．０ｍｍ～６．０ｍｍ程度の所定範囲内に規定されているので、ステムインサーター２のキー部２２及び大腿骨ステム１の本体部１１の耐久性を向上させることができる。なお、キー溝１６の幅Ｗ１が小さすぎると、ステムインサーター２のキー部２２が薄くなることになり、キー部２２の耐久性が低下する懸念がある。また、キー溝１６の幅Ｗ１が大きすぎると、キー溝１６の彫り込みが大きくなることになり、本体部１１の耐久性が低下する懸念がある。 (13) Since the width W1 (length in the anteroposterior direction) of the key groove 16 is defined within a predetermined range of about 1.0 mm to 6.0 mm, the key portion 22 of the stem inserter 2 and the femur stem 1 The durability of the main body 11 can be improved. If the width W1 of the key groove 16 is too small, the key portion 22 of the stem inserter 2 becomes thin, and there is a concern that the durability of the key portion 22 may decrease. Further, if the width W1 of the key groove 16 is too large, the engraving of the key groove 16 becomes large, and there is a concern that the durability of the main body portion 11 may decrease.
（１４）キー溝１６の実効深さＤ１（先端部２１の先端部中心Ｏ１からキー溝１６底面までの距離）は、先端部２１の半径が４．５ｍｍの場合、５．０ｍｍ～１０．０ｍｍ程度に規定されているので、ステムインサーター２による大腿骨ステム１の回旋性を確保し、大腿骨ステム１の本体部１１の耐久性を向上させることができる。なお、キー溝１６の実効深さＤ１が浅すぎると、ステムインサーター２によって大腿骨ステム１を回旋させることが難しくなる懸念がある。また、キー溝１６の実効深さＤ１が深すぎると、キー溝１６の彫り込みが大きくなることになり、本体部１１の耐久性が低下する懸念がある。 (14) The effective depth D1 of the key groove 16 (distance from the tip center O1 of the tip 21 to the bottom surface of the key groove 16) is 5.0 mm to 10.0 mm when the radius of the tip 21 is 4.5 mm. Since the degree is specified, the rotational property of the femur stem 1 by the stem inserter 2 can be ensured, and the durability of the main body 11 of the femur stem 1 can be improved. If the effective depth D1 of the keyway 16 is too shallow, there is a concern that it will be difficult for the stem inserter 2 to rotate the femoral stem 1. Further, if the effective depth D1 of the key groove 16 is too deep, the engraving of the key groove 16 becomes large, and there is a concern that the durability of the main body portion 11 may decrease.
（１５）キー溝１６の実質深さＤ２（球面部１５からキー溝１６底面までの距離）は、先端部２１の半径が４．５ｍｍの場合、０．５ｍｍ～５．５ｍｍ程度に規定されているので、ステムインサーター２による大腿骨ステム１の回旋性を確保し、本体部１１の耐久性を向上させることができる。なお、キー溝１６の実質深さＤ２が浅すぎると、ステムインサーター２によって大腿骨ステム１を回旋させることが難しくなる懸念がある。また、キー溝１６の実質深さＤ２が深すぎると、キー溝１６の彫り込みが大きくなることになり、本体部１１の耐久性が低下する懸念がある。 (15) The actual depth D2 of the key groove 16 (distance from the spherical surface portion 15 to the bottom surface of the key groove 16) is defined to be about 0.5 mm to 5.5 mm when the radius of the tip portion 21 is 4.5 mm. Therefore, the rotational property of the femoral stem 1 by the stem inserter 2 can be ensured, and the durability of the main body portion 11 can be improved. If the substantial depth D2 of the keyway 16 is too shallow, there is a concern that it will be difficult for the stem inserter 2 to rotate the femoral stem 1. Further, if the actual depth D2 of the key groove 16 is too deep, the engraving of the key groove 16 becomes large, and there is a concern that the durability of the main body portion 11 may decrease.
（１６）大腿骨ステム１の凹部１４は、遠位端部にネジ穴１４ａを有している。したがって、大腿骨ステム１は、先端部にネジ部を有するステム抜去器を使用することができ、大腿骨ステム１を大腿骨１００の髄腔１０１から抜き取ることができる。 (16) The recess 14 of the femur stem 1 has a screw hole 14a at the distal end. Therefore, for the femur stem 1, a stem remover having a threaded portion at the tip can be used, and the femur stem 1 can be extracted from the medullary cavity 101 of the femur 100.
（１７）キー部２２は、キー溝１６底面には接触しない形状となっているので、ステムインサーター２を別の工具（ハンマー）等で叩いて大腿骨ステム１を挿入する際、キー部２２に負荷がかかりにくいようにすることができる。 (17) Since the key portion 22 has a shape that does not contact the bottom surface of the key groove 16, the key portion 22 is inserted when the femur stem 1 is inserted by hitting the stem inserter 2 with another tool (hammer) or the like. It is possible to reduce the load on the stem.
　上記実施形態では、キー溝１６は、球面部１５の内側先端から内側に向かって延びるように１つ形成されているが、複数形成されてもよい。その場合でも、凹部１４をステム中心軸Ｓ１に近づけるために、複数のキー溝はいずれも、球面部１５の内側の縁部から内側に向かって延びるのが好ましい。 In the above embodiment, one key groove 16 is formed so as to extend inward from the inner tip of the spherical surface portion 15, but a plurality of key grooves 16 may be formed. Even in that case, in order to bring the recess 14 closer to the stem central axis S1, it is preferable that all of the plurality of keyways extend inward from the inner edge of the spherical portion 15.
　特許請求の範囲に記載された本発明の精神及び範囲から逸脱することなく、各種変形及び変更を行うことも可能である。 It is also possible to make various modifications and changes without departing from the spirit and scope of the present invention described in the claims.
　本発明では、ステムインサーター２の回旋角度を調整可能としながら、大腿骨ステム１とステムインサーター２との接触面積を増加させることができる大腿骨ステム１及び人工股関節システム１０を提供できるので、産業上の利用価値が大である。 According to the present invention, it is possible to provide the femur stem 1 and the artificial hip joint system 10 capable of increasing the contact area between the femur stem 1 and the stem inserter 2 while making the rotation angle of the stem inserter 2 adjustable. It has great industrial utility value.
１　大腿骨ステム　
１１　本体部　１２　ネック部　
１１ａ　近位部　１１ｂ　遠位部　
１３　肩部　
１４　凹部　
１５　球面部　
１６　キー溝　
２　ステムインサーター　
２１　先端部　２２　キー部　
１０　人工股関節システム　
１００　大腿骨　
Ｓ１　ステム中心軸
Ｓ２　基準線
Ｏ１　先端部中心　
Ｏ２　回旋軸　 1 Femoral stem
11 Main body 12 Neck
11a Proximal 11b Distal
13 Shoulder
14 recess
15 Spherical part
16 keyway
2 Stem inserter
21 Tip 22 Key
10 Artificial hip joint system
100 femur
S1 Stem center axis S2 Reference line O1 Tip center
O2 rotation axis

Claims (9)

  1. 　人工股関節の大腿骨ステムであって、
    　大腿骨の髄腔に挿入される本体部と、
    　ステムヘッドが取り付けられるネック部と、を有し、
    　前記本体部の肩部には、ステムインサーターの先端部が収容される凹部が形成されており、
    　前記凹部は、前記ステムインサーターの先端部と接触する球面部と、前記球面部から内側に向かって延び、前記ステムインサーターの回動を規制するキー溝と、を有している、大腿骨ステム。
    The femoral stem of the hip prosthesis
    The body that is inserted into the medullary cavity of the femur,
    Has a neck part to which the stem head is attached,
    A recess is formed in the shoulder portion of the main body portion to accommodate the tip portion of the stem inserter.
    The femur has a spherical portion that comes into contact with the tip end portion of the stem inserter and a key groove that extends inward from the spherical portion and regulates the rotation of the stem inserter. Stem.
  2. 　前記球面部は、前記ステムインサーターの先端部と円弧面で接触するようになっている、請求項１記載の大腿骨ステム。
    The femoral stem according to claim 1, wherein the spherical surface portion is in contact with the tip end portion of the stem inserter on an arc surface.
  3. 　前記キー溝は、前記球面部の内側先端から内側に向かって延びている、請求項１記載の大腿骨ステム。
    The femoral stem according to claim 1, wherein the keyway extends inward from the medial tip of the spherical portion.
  4. 　前記キー溝の内外側方向長さは、前記球面部の径よりも短くなっている、請求項１記載の大腿骨ステム。
    The femoral stem according to claim 1, wherein the length of the keyway in the medial-lateral direction is shorter than the diameter of the spherical surface portion.
  5. 　前記キー溝の幅は、前記球面部の径よりも短くなっている、請求項１記載の大腿骨ステム。
    The femoral stem according to claim 1, wherein the width of the keyway is shorter than the diameter of the spherical surface portion.
  6. 　請求項１記載の大腿骨ステムと、
    　前記大腿骨ステムを大腿骨の髄腔に挿入するステムインサーターと、を備え、
    　前記ステムインサーターは、前記球面部に接触する球体状の先端部と、前記キー溝に係合するキー部を備えている、人工股関節システム。
    The femoral stem according to claim 1 and
    A stem inserter for inserting the femoral stem into the medullary cavity of the femur is provided.
    The stem inserter is an artificial hip joint system including a spherical tip portion that contacts the spherical surface portion and a key portion that engages with the key groove.
  7. 　前記キー部は、前記先端部から外方に突出するように形成されている、請求項６記載の人工股関節システム。
    The artificial hip joint system according to claim 6, wherein the key portion is formed so as to project outward from the tip portion.
  8. 　前記キー部の前端は、側面視で円弧形状を有している、請求項６記載の人工股関節システム。
    The artificial hip joint system according to claim 6, wherein the front end of the key portion has an arc shape in a side view.
  9. 　前記ステムインサーターの先端部は、前記球面部に対して円弧面で接触するようになっている、請求項６記載の人工股関節システム。 The artificial hip joint system according to claim 6, wherein the tip end portion of the stem inserter comes into contact with the spherical surface portion on an arc surface.
PCT/JP2022/000649 2021-01-13 2022-01-12 Femoral stem and artificial hip joint system WO2022153992A1 (en)

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6626913B1 (en) * 1999-03-03 2003-09-30 Smith & Nephew, Inc. Methods, systems, and instruments for inserting prosthetic implants
WO2015098729A1 (en) * 2013-12-27 2015-07-02 京セラメディカル株式会社 Artificial hip joint stem, stem inserter, artificial hip joint system provided therewith, and artificial hip joint

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6626913B1 (en) * 1999-03-03 2003-09-30 Smith & Nephew, Inc. Methods, systems, and instruments for inserting prosthetic implants
WO2015098729A1 (en) * 2013-12-27 2015-07-02 京セラメディカル株式会社 Artificial hip joint stem, stem inserter, artificial hip joint system provided therewith, and artificial hip joint

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