WO2021082838A1 - 胫骨假体与膝关节假体 - Google Patents

胫骨假体与膝关节假体 Download PDF

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Publication number
WO2021082838A1
WO2021082838A1 PCT/CN2020/117950 CN2020117950W WO2021082838A1 WO 2021082838 A1 WO2021082838 A1 WO 2021082838A1 CN 2020117950 W CN2020117950 W CN 2020117950W WO 2021082838 A1 WO2021082838 A1 WO 2021082838A1
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Prior art keywords
tibial
pad
axis
prosthesis
mounting
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PCT/CN2020/117950
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English (en)
French (fr)
Inventor
黄欢欢
孙延东
赵开宇
翁资欣
Original Assignee
苏州微创关节医疗科技有限公司
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Application filed by 苏州微创关节医疗科技有限公司 filed Critical 苏州微创关节医疗科技有限公司
Priority to US17/773,743 priority Critical patent/US20220378581A1/en
Publication of WO2021082838A1 publication Critical patent/WO2021082838A1/zh

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    • AHUMAN NECESSITIES
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    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
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    • A61F2/389Tibial components
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    • A61F2/00Filters 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
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    • A61F2/00Filters 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
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    • A61F2002/30329Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30331Connections 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
    • A61F2002/30332Conically- or frustoconically-shaped protrusion and recess
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    • A61FFILTERS 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
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    • A61F2002/30329Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30331Connections 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
    • A61F2002/30354Cylindrically-shaped protrusion and recess, e.g. cylinder of circular basis
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    • A61F2002/30329Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
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    • A61F2002/30329Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30383Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by laterally inserting a protrusion, e.g. a rib into a complementarily-shaped groove
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    • A61F2002/30329Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
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Definitions

  • the invention relates to the technical field of medical devices, in particular to a tibial prosthesis and a knee joint prosthesis.
  • the tibial pad is usually installed at the central recess of the tibial platform through the extension shaft at the bottom to achieve radial restraint, while providing rotational freedom, so as to realize the tibial pad around the center Rotation function.
  • the internal axis movement refers to the transition of the knee joint between the extension and flexion states, the rolling of the femoral condyle on the tibial pad takes the center of the ball and socket joint formed by the medial condyle and the inner articular surface of the tibial pad as the axis.
  • the lateral condyle rotates along the axis of the lateral articular surface of the tibial pad.
  • the medial rotation axis movable platform is improved on the basis of the traditional movable platform.
  • the internal axis movement between the tibial liner and the tibial platform is generated, thereby increasing the movement of the internal axis.
  • Range of internal and external rotation Since the mechanics of the human knee joint is biased to the inside of the articular surface, the inwardly offset rotation axis is conducive to bearing the body's own pressure and the joint shear force during exercise, and improves the stability of the prosthesis to a certain extent.
  • the purpose of the present invention is to provide a tibial prosthesis and a knee joint prosthesis to solve the problem that the surface of the existing knee joint prosthesis is easy to wear.
  • a tibial prosthesis which includes:
  • the proximal end surface of the tibial plateau has a mounting surface arranged along the first axis direction;
  • a first tibial pad the first tibial pad is rotatably disposed on the mounting surface around the first axis, and the included angle between the normal direction of the mounting surface and the first axis is 0° ⁇ Within a range of 5°, the first tibial pad has a first concave surface centered on the first axis, and the first concave surface is recessed toward the distal end; and
  • a second tibial pad is disposed on the tibial platform, the second tibial pad has a second concave surface, and the second concave surface is along an arc-shaped trajectory line parallel to the mounting surface Extending, the center of the arc-shaped trajectory is located on the first axis, and the second concave surface is recessed toward the distal end;
  • the first tibial pad and the second tibial pad are arranged independently of each other, and the first tibial pad is located inside the second tibial pad.
  • the second tibial pad and the tibial plateau are detachably connected.
  • one of the distal surface of the second tibial pad and the proximal surface of the tibial platform is provided with a locking groove, and the other is provided with a protruding tooth matching the locking groove, and the second The tibial pad and the tibial platform are assembled and connected by the clamping groove and the protruding tooth in a direction perpendicular to the first axis.
  • the card slot is a tapered slot or a rectangular slot.
  • one of the tibial platform is provided with a mounting hole in the region of the mounting surface and the distal surface of the first tibial pad, and the other is provided with a mounting post matching the mounting hole;
  • the axis of the mounting post and the axis of the mounting hole coincide with the first axis, and the mounting post is rotatably inserted into the mounting hole around the first axis.
  • the mounting post and the mounting hole are both cylindrical.
  • the tibial platform includes a post, the axis of the post is parallel to the first axis, and the post is arranged on the distal side of the tibial platform.
  • the first concave surface is a spherical surface, and the center of the spherical surface is located on the first axis.
  • the cross section of the first tibial pad is circular.
  • the present invention also provides a knee joint prosthesis, which includes a femoral condyle prosthesis and the tibial prosthesis as described above, the femoral condyle prosthesis includes a medial condyle and a lateral condyle, and the tibial prosthesis
  • the first tibial pad of the body corresponds to the medial condyle
  • the second tibial pad of the tibial prosthesis corresponds to the lateral condyle
  • the medial condyle rotates relative to the first tibial pad
  • the first tibial pad rotates relative to the tibial plateau
  • the lateral condyle is rolling on the second tibial pad
  • the second tibial pad is relatively stationary with the tibial plateau.
  • the tibial prosthesis includes a tibial plateau, a first tibial pad and a second tibial pad, and the proximal surface of the tibial plateau has a mounting surface;
  • the first tibial pad is rotatably arranged on the mounting surface around a first axis, and the included angle between the normal direction of the mounting surface and the first axis is in the range of 0° to 5°.
  • the first tibial pad has a first concave surface centered on the first axis, and the first concave surface is recessed toward the distal end; the second tibial pad is disposed on the tibial plateau, and the second tibial pad
  • the pad has a second concave surface that extends along an arc-shaped trajectory line parallel to the mounting surface, the center of the arc-shaped trajectory line is located on the first axis, and the second concave surface is recessed toward the distal end
  • the first tibial pad and the second tibial pad are arranged independently of each other, and the first tibial pad is located inside the second tibial pad.
  • two independent tibial pads corresponding to the medial and lateral condyles are provided, wherein the first tibial pad corresponds to the medial condyle, the second tibial pad corresponds to the lateral condyle, and the first tibial pad and the tibial plateau are relatively rotatable, The second tibial pad remains relatively static with the tibial plateau to ensure the relative stability of the lateral condyle.
  • the dual axial rotation of the medial condyle can be realized (the relative rotation of the medial condyle and the first tibial pad, and the relative rotation of the first tibial pad and the tibial platform), Thereby reducing the risk of tibial prosthesis wear.
  • Fig. 1 is an overall schematic diagram of a tibial prosthesis provided by an embodiment of the present invention
  • Figure 2 is a schematic diagram of a tibial platform provided by an embodiment of the present invention.
  • Figure 3 is a schematic diagram of a first tibial pad provided by an embodiment of the present invention.
  • Figure 4 is an exploded view of a tibial prosthesis provided by an embodiment of the present invention.
  • Figure 5 is a top view of a tibial prosthesis provided by an embodiment of the present invention.
  • Figure 6 is a schematic diagram of a second tibial pad provided by an embodiment of the present invention.
  • Fig. 7 is a schematic diagram of an axial section of a tibial prosthesis provided by an embodiment of the present invention.
  • FIG. 8a and 8b are schematic diagrams of a card slot provided by an embodiment of the present invention.
  • FIGS 9a-9d are schematic diagrams of mounting holes and mounting posts provided by an embodiment of the present invention.
  • 2-first tibial pad 2a-first concave surface; 2b-mounting post; 2bc-first axis;
  • 3-Second tibial pad 3a-second concave surface; 3ac-center of arc trajectory; 3at-arc trajectory; 3b-convex tooth.
  • the singular forms “a”, “an” and “the” include plural referents unless the content clearly dictates otherwise.
  • the term “or” is generally used to include the meaning of “and/or”, unless the content clearly dictates otherwise, the term “inside” generally refers to close to the human body The side of the mid-sagittal plane, the term “outside” usually refers to the side away from the mid-sagittal plane of the human body.
  • “Left” and “Right” refer to the left and right sides of the human body when the prosthesis is placed in the orientation in which it is implanted in the human body.
  • Proximal refers to the end close to the human heart, and “distal” refers to the end away from the human heart.
  • the core idea of the present invention is to provide a tibial prosthesis and a knee joint prosthesis, wherein the tibial prosthesis includes a tibial plateau, a first tibial pad and a second tibial pad, and the proximal surface of the tibial plateau has a mounting
  • the first tibial pad is rotatably arranged on the mounting surface around a first axis, and the angle between the normal direction of the mounting surface and the first axis is in the range of 0°-5°,
  • the first tibial pad has a first concave surface centered on the first axis, and the first concave surface is recessed toward the distal end; the second tibial pad is disposed on the tibial plateau, and the second
  • the tibial pad has a second concave surface that extends along an arc-shaped trajectory line parallel to the mounting surface, the center of the arc-shaped trajectory line is located on the first axis, and the second
  • the end is recessed; the first tibial pad and the second tibial pad are arranged independently of each other, and the first tibial pad is located on the inner side of the second tibial pad.
  • two independent tibial pads corresponding to the medial and lateral condyles are provided, wherein the first tibial pad corresponds to the medial condyle, the second tibial pad corresponds to the lateral condyle, and the first tibial pad and the tibial plateau are relatively rotatable,
  • the second tibial pad ensures the relative stability of the lateral condyle.
  • the dual axial rotation of the medial condyle can be realized (the relative rotation of the medial condyle and the first tibial pad, and the relative rotation of the first tibial pad and the tibial platform), Thereby reducing the risk of tibial prosthesis wear.
  • FIG. 1 is an overall schematic view of a tibial prosthesis provided by an embodiment of the present invention
  • Figure 2 is a tibial prosthesis provided by an embodiment of the present invention
  • FIG. 3 is a schematic diagram of a first tibial pad provided by an embodiment of the present invention
  • FIG. 4 is an exploded view of a tibial prosthesis provided by an embodiment of the present invention
  • FIG. 5 is a tibia provided by an embodiment of the present invention.
  • Figure 6 is a schematic diagram of a second tibial pad provided by an embodiment of the present invention.
  • Figure 7 is a schematic diagram of an axial cross-section of a tibial prosthesis provided by an embodiment of the present invention.
  • Figures 8a and 8b are the present invention.
  • FIGS. 9a to 9d are schematic diagrams of a mounting hole and a mounting post provided by an embodiment of the present invention.
  • an embodiment of the present invention provides a tibial prosthesis, which includes: a tibial plateau 1, a first tibial pad 2 and a second tibial pad 3, the tibial plateau 1
  • the proximal end surface of the has a mounting surface 1a arranged along the first axis direction, that is, the mounting surface 1a faces the human femur direction (upward in the figure); the first tibial pad 2 is rotatably arranged around the first axis 2bc
  • the first axis 2bc is located at the position of the tibial platform 1 corresponding to the medial condyle, and is the axis of rotation of the prosthesis for internal axial movement.
  • the first axis 2bc is substantially perpendicular to the mounting surface 1a, that is, the angle between the normal direction of the mounting surface 1a and the first axis 2bc is in the range of 0° to 5° (that is, the method of the mounting surface 1a The angle between the first axis 2bc and the first axis 2bc is greater than or equal to 0° and less than or equal to 5°).
  • the first axis 2bc is perpendicular to the mounting surface 1a.
  • the first tibial pad 2 has a first concave surface 2a centered on the first axis 2bc, and the first concave surface 2a is recessed toward the distal end.
  • the first concave surface 2a is a spherical surface (ball-and-socket-shaped joint surface) ,
  • the center of the spherical surface is located on the first axis 2bc;
  • the second tibial pad 3 is disposed on the tibial plateau 1,
  • the second tibial pad 3 has a second concave surface 3a,
  • the second tibial pad 3 has a second concave surface 3a.
  • the two concave surfaces 3a extend along an arc-shaped trajectory line 3at parallel to the mounting surface 1a, the center 3ac of the arc-shaped trajectory line 3at is located on the first axis 2bc, and the second concave surface 3a is recessed toward the distal end.
  • the first tibial pad 2 and the second tibial pad 3 are arranged in the left-right direction independently of each other.
  • the first tibial pad 2 is located opposite to the inner side of the second tibial pad 3, and two tibial pads with independent medial and lateral condyles are provided.
  • the first tibial pad 2 and the second tibial pad 3 wherein the first tibial pad 2 corresponds to the medial condyle, the second tibial pad 3 corresponds to the lateral condyle, the first tibial pad 2 and the tibial plateau 1 Relatively rotatable, it increases the degree of freedom of the knee joint and improves the fit between the tibia and the tibial prosthesis when the internal axis moves.
  • the second tibial pad 3 remains relatively stationary with the tibial plateau, ensuring the relative stability of the lateral condyle, and ensuring the safety of the tibial prosthesis.
  • the first concave surface 2a of the first tibial pad 2 is matched with the medial condyle of the femoral condyle, so that the medial condyle rotates relative to the first tibial pad 2 around the first axis 2bc, and the first tibial pad 2 can be relatively
  • the tibial platform 1 rotates around the first axis 2bc, and the rotation of the medial condyle is realized through double rotation;
  • the second concave surface 3a of the second tibial pad 3 is matched with the lateral condyle of the femoral condyle, so that the lateral condyle is under different knee flexion angles It can roll along the arc-shaped trajectory 3at of the second tibial pad 3.
  • the center 3ac of the arc-shaped trajectory line 3at is also located on the first axis 2bc, that is, the rotation centers of the medial and lateral condyles overlap, and they are both located in the load-bearing area on the medial side of the knee joint, so that the inner axis movement is more in line with the characteristics of the natural knee joint movement of the human body , So it helps to improve the stability of the tibial prosthesis.
  • the dual axial rotation of the medial condyle can be realized (the medial condyle rotates relative to the first tibial pad 2 and the first tibial pad 2 rotates with the tibial platform 1 ), because the friction between the medial condyle and the tibial pad is resolved into two rotational degrees of freedom of the medial condyle relative to the first tibial pad 2 and the first tibial pad 2 relative to the tibial plateau 1, thereby reducing the wear of the tibial prosthesis risks of.
  • the tibial prosthesis shown in Figure 1 actually corresponds to the right knee joint of humans, while the tibial prosthesis corresponding to the left knee joint is in a mirror image relationship with the tibial prosthesis of Figure 1.
  • the tibial prosthesis With a variety of sizes and specifications, it can be adapted to the needs of different patients.
  • the tibial platform 1 includes a post 1b, the axis of the post 1b is parallel to the first axis 2bc, and the post is arranged on the distal side of the tibial platform, the The upright 1b extends from the distal end side to the distal end of the mounting surface 1a.
  • the post 1b is used to be implanted into the tibia of a patient and fixedly connected to the tibia. It is preferably a cylindrical body. The distal end of the post 1b can be a rounded ball head to facilitate surgical implantation of the tibia.
  • the second tibial pad 3 and the tibial platform 1 are detachably connected, so that the doctor can select a tibial pad with a suitable specification for matching and installation according to the anatomical structure and size of different patients.
  • one of the distal surface of the second tibial pad 3 and the proximal surface of the tibial platform 1 is provided with a locking groove 1a1, and the other is provided with a protruding tooth 3b matching the locking groove 1a1
  • the second tibial pad 3 and the tibial platform 1 are assembled and connected by the engaging groove 1a1 and the convex tooth 3b in a direction perpendicular to the first axis.
  • the proximal surface of the tibial platform 1 is provided with a slot 1a1 (mainly provided around the mounting surface 1a and close to the tibial platform 1
  • the outer area of the second tibial pad 3 is provided with convex teeth 3b on the distal surface, and the second tibial pad 3 and the tibial platform 1 can be reliably connected by the engagement of the groove 1a1 and the convex teeth 3b. (Achieving locking), there is no degree of freedom between the two in the axial and circumferential directions, so that the stability of the second tibial pad 3 can be well ensured.
  • the slot 1a1 and the protruding teeth 3b are assembled in a direction perpendicular to the first axis 2bc, that is, the second tibial pad 3 is inserted and assembled along the radial direction of the tibial platform 1.
  • the card slot can have several forms.
  • Figure 8a illustrates a cross-sectional view when the card slot is a tapered slot
  • Figure 8b illustrates a cross-sectional view when the card slot is a rectangular slot.
  • the groove can also be in other forms, such as a semi-circular groove.
  • the shape of the protruding teeth 3b matches the shape of the groove 1a1, and the two can be tightly engaged.
  • the bottom of the second tibial pad 3 is provided with a slot 1a1
  • the tibial plateau 1 is provided with convex teeth 3b, which can also realize the second tibial pad 3 and the tibial plateau 1. ⁇ Snap-in connection.
  • the second tibial pad 3 may also be detachably connected with the tibial platform 1 in other ways, such as by a buckle or pin, etc. The present invention is not limited to this.
  • one of the tibial platform 1 is provided with a mounting hole 1a2 in the region of the mounting surface 1a and the distal surface of the first tibial pad 2, and the other is provided with a mounting hole 1a2 that matches the mounting hole 1a2.
  • the tibial platform 1 is provided with a mounting hole 1a2 in the region of the mounting surface 1a, and oppositely, the first tibial pad 2
  • the bottom (that is, the distal end) is provided with a mounting post 2b.
  • the outer contour size of the mounting post 2b is slightly smaller than the inner size of the mounting hole 1a2, so that the mounting post 2b can be inserted into the mounting hole 1a2 and can rotate.
  • the axis of the mounting post 2b coincides with the first axis 2bc.
  • Figures 9a-9d illustrate various forms of the mounting post 2b and the mounting hole 1a2.
  • Figure 9a illustrates the cylindrical mounting post 2b and the mounting hole 1a2
  • Figure 9b illustrates the hemispherical mounting post 2b and the mounting hole 1a2.
  • Figure 9c illustrates the concave-convex-shaped mounting post 2b and the mounting hole 1a2
  • Figure 9d illustrates the frustum-shaped mounting post 2b and the mounting hole 1a2.
  • the above multiple forms can meet the assembly requirements of the mounting post 2b and the mounting hole 1a2, so that The mounting hole 1a2 can define the radial and axial degrees of freedom of the mounting post 2b, while retaining the circumferential freedom between the two.
  • the forms of the mounting post 2b and the mounting hole 1a2 shown in Figures 9a to 9d are only illustrative, and the form of the mounting post 2b and the mounting hole 1a2 is not limited to those shown in Figures 9a to 9d, and it can also be other Form, such as dovetail ( ⁇ -shape) or cone.
  • the bottom of the first tibial pad 2 is provided with a mounting hole 1a2, and oppositely, the tibial platform 1 is provided with a mounting post 2b in the area of the mounting surface 1a, which can also The rotation connection of the first tibial pad 2 with respect to the tibial platform 1 is realized.
  • the mounting post 2b and the mounting hole 1a2 are both cylindrical, and the mounting is convenient and the structure is simple.
  • the cross-section of the first tibial pad 2 is circular, and when the first tibial pad 2 rotates relative to the tibial plateau 1, it is avoided to collide with the second tibial pad 3.
  • the present invention also provides a knee joint prosthesis, which includes a femoral condyle prosthesis and the tibial prosthesis as described above, the femoral condyle prosthesis includes a medial condyle and a lateral condyle, and the first tibial pad corresponds to In the medial condyle, the second tibial pad corresponds to the lateral condyle, and when the femoral condyle prosthesis and the tibial prosthesis move in relative flexion, the medial condyle and the first tibial pad While relative rotation, the first tibial pad and the tibial plateau rotate relatively; while the lateral condyle is rolling on the second tibial pad, the second tibial pad and the tibial plateau are held Relatively static.
  • the knee joint prosthesis includes the tibial prosthesis as described above, it also has the beneficial effects brought about by the above-mentioned tibial prosthesis, and those skilled in the art can perform treatment on the femoral condyle prosthesis in the knee joint prosthesis according to the prior art. Appropriate configuration, no more details here.
  • the tibial prosthesis includes a tibial plateau, a first tibial pad and a second tibial pad, and the proximal surface of the tibial plateau has a mounting surface;
  • the first tibial pad is rotatably disposed on the mounting surface around a first axis, and the included angle between the normal direction of the mounting surface and the first axis is in the range of 0° to 5°, and
  • a tibial pad has a first concave surface centered on the first axis, and the first concave surface is recessed toward the distal end;
  • the second tibial pad is disposed on the tibial plateau, and the second tibial pad Having a second concave surface, the second concave surface extending along an arc-shaped trajectory line parallel to the mounting surface, the center of the arc-shaped trajectory line is located on the first axis, and the second concave
  • two independent tibial pads corresponding to the medial and lateral condyles are provided, wherein the first tibial pad corresponds to the medial condyle, the second tibial pad corresponds to the lateral condyle, and the first tibial pad and the tibial plateau are relatively rotatable, The second tibial pad remains relatively static with the tibial plateau to ensure the relative stability of the lateral condyle.
  • the dual axial rotation of the medial condyle can be realized (the relative rotation of the medial condyle and the first tibial pad, and the relative rotation of the first tibial pad and the tibial platform), Thereby reducing the risk of tibial prosthesis wear.

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Abstract

一种胫骨假体与膝关节假体,胫骨假体包括胫骨平台(1)、第一胫骨衬垫(2)以及第二胫骨衬垫(3),该胫骨平台(1)的近端面具有沿第一轴线(2bc)方向设置的安装面(1a);该第一胫骨衬垫(2)围绕该第一轴线(2bc)可转动地设置于该安装面(1a)上,该第一胫骨衬垫(2)具有以该第一轴线(2bc)为中心的第一凹面(2a),该第一凹面(2a)朝向远端凹陷;该第二胫骨衬垫(3)设置于该胫骨平台(1)上,该第二胫骨衬垫(3)具有第二凹面(3a),该第二凹面(3a)沿平行于该安装面(1a)的弧形轨迹线(3at)延伸,该弧形轨迹线(3at)的圆心(3ac)位于该第一轴线(2bc)上,该第二凹面(3a)朝向远端凹陷;该第一胫骨衬垫(2)和该第二胫骨衬垫(3)相互独立地布置,且该第一胫骨衬垫(2)位于该第二胫骨衬垫(3)的内侧。

Description

胫骨假体与膝关节假体 技术领域
本发明涉及医疗器械技术领域,特别涉及一种胫骨假体与膝关节假体。
背景技术
在现有的活动平台式的膝关节假体中,胫骨衬垫通常通过底部的延伸轴安装于胫骨平台的中央凹孔处以实现径向约束,同时提供旋转自由度,从而实现胫骨衬垫绕中央旋转的功能。但是这样的设计所实现的旋转与膝关节天然的内轴型运动有较大差距。内轴型运动是指,膝关节在伸直和屈曲这两种状态间转换时,股骨髁在胫骨衬垫上的滚动以内侧髁与胫骨衬垫内侧关节面形成的球窝关节中心为轴,外侧髁沿胫骨衬垫的外侧关节面绕轴旋转的运动轨迹。对此,基于传统活动平台的基础上进行改进得到的内侧旋转轴活动平台,通过胫骨衬垫旋转轴向内侧偏移,使胫骨衬垫与胫骨平台间产生内轴运动,从而增加内轴运动的内外旋活动范围。由于人体膝关节力学偏向于关节面内侧,向内侧偏移的旋转轴有利于对人体自身压力以及运动过程中关节剪切力的承载,一定程度上提高假体的稳定性。然而,由于旋转轴向内侧偏移,导致胫骨衬垫的外侧部分摆动幅度较大、速度较快,旋转轴对其约束力不足,易造成衬垫与平台脱位,从另一角度又降低了假体的稳定性。
此外,现在还存在固定平台的内轴型膝关节假体,其一般通过胫骨衬垫内侧关节面的表面约束,以及外侧关节面的相对转动,实现膝关节假体的内轴运动功能。然而,这种方式常使得胫骨衬垫与股骨髁之间具有较大的相对位移,从而增加膝关节假体与与股骨髁的表面磨损的风险,提高了翻修率。
发明内容
本发明的目的在于提供一种胫骨假体与膝关节假体,以解决现有的膝关节假体表面易磨损的问题。
为解决上述技术问题,本发明提供了一种胫骨假体,其包括:
胫骨平台,所述胫骨平台的近端面具有沿第一轴线方向设置的安装面;
第一胫骨衬垫,所述第一胫骨衬垫围绕所述第一轴线可转动地设置于所述安装面上,所述安装面的法向与所述第一轴线的夹角在0°~5°的范围内,所述第一胫骨衬垫具有以所述第一轴线为中心的第一凹面,所述第一凹面朝向远端凹陷;以及
第二胫骨衬垫,所述第二胫骨衬垫设置于所述胫骨平台上,所述第二胫骨衬垫具有第二凹面,所述第二凹面沿平行于所述安装面的弧形轨迹线延伸,所述弧形轨迹线的圆心位于所述第一轴线上,所述第二凹面朝向远端凹陷;
所述第一胫骨衬垫和所述第二胫骨衬垫相互独立地布置,且所述第一胫骨衬垫位于所述第二胫骨衬垫的内侧。
可选的,所述第二胫骨衬垫与所述胫骨平台为可拆卸地连接。
可选的,所述第二胫骨衬垫的远端面与所述胫骨平台的近端面之一设有卡槽,另一设有与所述卡槽相匹配的凸齿,所述第二胫骨衬垫与所述胫骨平台通过所述卡槽与所述凸齿沿垂直于所述第一轴线的方向相卡合而装配连接。
可选的,所述卡槽为锥形槽或矩形槽。
可选的,所述胫骨平台于所述的安装面的区域与所述第一胫骨衬垫的远端面之一设有安装孔,另一设有与所述安装孔相匹配的安装柱;所述安装柱的轴线与所述安装孔的轴线重合于所述第一轴线,所述安装柱围绕所述第一轴线可转动地插设于所述安装孔中。
可选的,所述安装柱与所述安装孔均为圆柱形。
可选的,所述胫骨平台包括立柱,所述立柱的轴线平行于所述第一轴线,且所述立柱设置于所述胫骨平台的远端侧。
可选的,所述第一凹面为球面,所述球面的球心位于所述第一轴线上。
可选的,所述第一胫骨衬垫的横截面为圆形。
为解决上述技术问题,本发明还提供了一种膝关节假体,其包括股骨髁假体和如上所述的胫骨假体,所述股骨髁假体包括内侧髁和外侧髁,所述胫骨假体的第一胫骨衬垫对应于所述内侧髁,所述胫骨假体的第二胫骨衬垫对应于所述外侧髁,当所述股骨髁假体与所述胫骨假体作相对屈曲运动时,所 述内侧髁与所述第一胫骨衬垫相对转动的同时,所述第一胫骨衬垫与所述胫骨平台相对转动;所述外侧髁在所述第二胫骨衬垫上滚动的同时,所述第二胫骨衬垫与所述胫骨平台相对静止。
综上所述,本发明提供的胫骨假体与膝关节假体中,胫骨假体包括胫骨平台、第一胫骨衬垫以及第二胫骨衬垫,所述胫骨平台的近端面具有安装面;所述第一胫骨衬垫围绕第一轴线可转动地设置于所述安装面上,所述安装面的法向与所述第一轴线的夹角在0°~5°的范围内,所述第一胫骨衬垫具有以所述第一轴线为中心的第一凹面,所述第一凹面朝向远端凹陷;所述第二胫骨衬垫设置于所述胫骨平台上,所述第二胫骨衬垫具有第二凹面,所述第二凹面沿平行于所述安装面的弧形轨迹线延伸,所述弧形轨迹线的圆心位于所述第一轴线上,所述第二凹面朝向远端凹陷;所述第一胫骨衬垫和所述第二胫骨衬垫相互独立地布置,且所述第一胫骨衬垫位于所述第二胫骨衬垫的内侧。如此配置,设置对应于内外侧髁独立的两个胫骨衬垫,其中第一胫骨衬垫对应于内侧髁,第二胫骨衬垫对应于外侧髁,第一胫骨衬垫与胫骨平台相对可转动,第二胫骨衬垫则与胫骨平台保持相对静止,保证外侧髁的相对稳定。这样在股骨髁与胫骨假体间进行内侧轴旋转运动时,能实现内侧髁的双重轴向转动(内侧髁与第一胫骨衬垫相对转动,以及第一胫骨衬垫与胫骨平台相对转动),从而减少胫骨假体磨损的风险。
附图说明
本领域的普通技术人员将会理解,提供的附图用于更好地理解本发明,而不对本发明的范围构成任何限定。其中:
图1是本发明一实施例提供的胫骨假体的整体示意图;
图2是本发明一实施例提供的胫骨平台的示意图;
图3是本发明一实施例提供的第一胫骨衬垫的示意图;
图4是本发明一实施例提供的胫骨假体的分解图;
图5是本发明一实施例提供的胫骨假体的俯视图;
图6是本发明一实施例提供的第二胫骨衬垫的示意图;
图7是本发明一实施例提供的胫骨假体的轴向截面的示意图;
图8a和图8b是本发明一实施例提供的卡槽的示意图;
图9a~图9d是本发明一实施例提供的安装孔与安装柱的示意图。
附图中:
1-胫骨平台;1a-安装面;1b-立柱;1a1-卡槽;1a2-安装孔;
2-第一胫骨衬垫;2a-第一凹面;2b-安装柱;2bc-第一轴线;
3-第二胫骨衬垫;3a-第二凹面;3ac-弧形轨迹线的圆心;3at-弧形轨迹线;3b-凸齿。
具体实施方式
为使本发明的目的、优点和特征更加清楚,以下结合附图和具体实施例对本发明作进一步详细说明。需说明的是,附图均采用非常简化的形式且未按比例绘制,仅用以方便、明晰地辅助说明本发明实施例的目的。此外,附图所展示的结构往往是实际结构的一部分。特别的,各附图需要展示的侧重点不同,有时会采用不同的比例。
如在本说明书和所附权利要求书中所使用的,单数形式“一”、“一个”以及“该”包括复数对象,除非内容另外明确指出外。如在本说明书和所附权利要求中所使用的,术语“或”通常是以包括“和/或”的含义而进行使用的,除非内容另外明确指出外,术语“内侧”通常是指靠近人体正中矢状面的一侧,术语“外侧”通常是指远离人体正中矢状面的一侧。“左”、“右”是指假体以植入人体的方位摆放时人体的左侧和右侧。“近端”指靠近人体心脏的一端,“远端”为远离人体心脏的一端。
本发明的核心思想在于提供一种胫骨假体与膝关节假体,其中所述胫骨假体包括胫骨平台、第一胫骨衬垫以及第二胫骨衬垫,所述胫骨平台的近端面具有安装面;所述第一胫骨衬垫围绕第一轴线可转动地设置于所述安装面上,所述安装面的法向与所述第一轴线的夹角在0°~5°的范围内,所述第一胫骨衬垫具有以所述第一轴线为中心的第一凹面,所述第一凹面朝向远端凹陷;所述第二胫骨衬垫设置于所述胫骨平台上,所述第二胫骨衬垫具有第二 凹面,所述第二凹面沿平行于所述安装面的弧形轨迹线延伸,所述弧形轨迹线的圆心位于所述第一轴线上,所述第二凹面朝向远端凹陷;所述第一胫骨衬垫和所述第二胫骨衬垫相互独立地布置,且所述第一胫骨衬垫位于所述第二胫骨衬垫的内侧。如此配置,设置对应于内外侧髁独立的两个胫骨衬垫,其中第一胫骨衬垫对应于内侧髁,第二胫骨衬垫对应于外侧髁,第一胫骨衬垫与胫骨平台相对可转动,第二胫骨衬垫则保证外侧髁的相对稳定。这样在股骨髁与胫骨假体间进行内侧轴旋转运动时,能实现内侧髁的双重轴向转动(内侧髁与第一胫骨衬垫相对转动,以及第一胫骨衬垫与胫骨平台相对转动),从而减少胫骨假体磨损的风险。
以下参考附图进行描述。
请参考图1至图7、图8a和图8b、图9a~图9d,其中,图1是本发明一实施例提供的胫骨假体的整体示意图,图2是本发明一实施例提供的胫骨平台的示意图,图3是本发明一实施例提供的第一胫骨衬垫的示意图,图4是本发明一实施例提供的胫骨假体的分解图,图5是本发明一实施例提供的胫骨假体的俯视图,图6是本发明一实施例提供的第二胫骨衬垫的示意图,图7是本发明一实施例提供的胫骨假体的轴向截面的示意图,图8a和图8b是本发明一实施例提供的卡槽的示意图,图9a~图9d是本发明一实施例提供的安装孔与安装柱的示意图。
如图1、图4和图5所示,本发明一实施例提供一种胫骨假体,其包括:胫骨平台1、第一胫骨衬垫2以及第二胫骨衬垫3,所述胫骨平台1的近端面具有沿第一轴线方向设置的安装面1a,即所述安装面1a朝向人体股骨方向(图中向上);所述第一胫骨衬垫2围绕第一轴线2bc可转动地设置于所述安装面1a上,所述第一轴线2bc位于胫骨平台1对应于内侧髁的位置,是该假体作内轴运动的旋转轴。需要说明的是,所述第一轴线2bc大致与安装面1a保持垂直,即安装面1a的法向与第一轴线2bc的夹角在0°~5°的范围内(即安装面1a的法向与第一轴线2bc的夹角大于或等于0°且小于或等于5°),优选,第一轴线2bc垂直于安装面1a。所述第一胫骨衬垫2具有以所述第一轴 线2bc为中心的第一凹面2a,所述第一凹面2a朝向远端凹陷,优选第一凹面2a为一球面(球窝状关节面),所述球面的球心位于所述第一轴线2bc上;所述第二胫骨衬垫3设置于所述胫骨平台1上,所述第二胫骨衬垫3具有第二凹面3a,所述第二凹面3a沿平行于所述安装面1a的弧形轨迹线3at延伸,所述弧形轨迹线3at的圆心3ac位于所述第一轴线2bc上,所述第二凹面3a朝向远端凹陷。
第一胫骨衬垫2和第二胫骨衬垫3相互独立地沿左右方向布置,第一胫骨衬垫2相对位于第二胫骨衬垫3的内侧,通过设置内外侧髁独立的两个胫骨衬垫(即第一胫骨衬垫2和第二胫骨衬垫3),其中第一胫骨衬垫2对应于内侧髁,第二胫骨衬垫3对应于外侧髁,第一胫骨衬垫2与胫骨平台1相对可转动,增加膝关节的自由度,提高内轴运动时,胫骨与胫骨假体的配合度。而第二胫骨衬垫3则与胫骨平台保持相对静止,保证外侧髁的相对稳定,保证胫骨假体的安全性。实际使用中,第一胫骨衬垫2的第一凹面2a与股骨髁的内侧髁配合,使内侧髁绕第一轴线2bc相对于第一胫骨衬垫2转动,同时第一胫骨衬垫2可相对于胫骨平台1绕第一轴线2bc转动,通过双重转动实现内侧髁的旋转活动;第二胫骨衬垫3的第二凹面3a与股骨髁的外侧髁配合,使外侧髁在不同膝关节屈曲角度下可沿第二胫骨衬垫3的弧形轨迹线3at滚动。由于弧形轨迹线3at的圆心3ac也位于第一轴线2bc上,即内侧髁和外侧髁的旋转中心重叠,均位于膝关节内侧的承重区,使内轴运动更符合人体自然膝关节运动的特点,因此有利于提高胫骨假体的稳定性。在股骨髁与胫骨假体间进行内侧轴旋转运动时,能实现内侧髁的双重轴向转动(内侧髁与第一胫骨衬垫2相对转动,以及第一胫骨衬垫2与胫骨平台1相对转动),由于将内侧髁与胫骨衬垫的摩擦分解到内侧髁相对第一胫骨衬垫2,以及第一胫骨衬垫2相对胫骨平台1的两个转动自由度中,从而减少了胫骨假体磨损的风险。
可以理解的,图1所示的胫骨假体实际上对应适用于人的右膝关节,而对应于左膝关节的胫骨假体则与图1的胫骨假体呈镜像关系,此外,胫骨假体具有多种尺寸规格,可适应不同患者的需要。可选的,请参考图2,所述胫 骨平台1包括立柱1b,所述立柱1b的轴线平行于所述第一轴线2bc,且所述立柱设置于所述胫骨平台的远端侧,所述立柱1b从安装面1a的远端侧向远端延伸。实际中,立柱1b用于植入患者的胫骨,并与胫骨固定连接,其优选为一圆柱体,立柱1b的远端端部可为圆滑的球头形,以便于手术植入胫骨。
优选的,第二胫骨衬垫3与所述胫骨平台1为可拆卸地连接,以便于医生根据不同患者的解剖结构、尺寸,选择合适规格的胫骨衬垫与胫骨平台进行搭配、安装。可选的,所述第二胫骨衬垫3的远端面与所述胫骨平台1的近端面之一设有卡槽1a1,另一设有与所述卡槽1a1相匹配的凸齿3b,所述第二胫骨衬垫3与所述胫骨平台1通过所述卡槽1a1与所述凸齿3b沿垂直于所述第一轴线的方向相卡合而装配连接。如图2、图7和图8a、8b所示,在一个示范性的实施例中,胫骨平台1的近端面设有卡槽1a1(主要设置于安装面1a的周围,且靠近胫骨平台1的外侧区域),而第二胫骨衬垫3的远端面设有凸齿3b,第二胫骨衬垫3与胫骨平台1能够通过卡槽1a1与凸齿3b的卡合而可靠地固定连接起来(实现锁定),两者之间无轴向和周向的自由度,从而能够很好地保证第二胫骨衬垫3的稳定性。较佳的,所述卡槽1a1与所述凸齿3b沿垂直于所述第一轴线2bc的方向装配,即第二胫骨衬垫3沿胫骨平台1的径向插入并进行装配。请参考图8a和图8b,可选的,卡槽可以有若干形式,图8a示意了卡槽为锥形槽时的截面图,图8b示意了卡槽为矩形槽时的截面图,当然卡槽还可以是其它形式的,如半圆形槽等。相应的,凸齿3b与卡槽1a1的形状相匹配,两者能够紧密地卡合。可以理解的,在其它的一些实施例中,第二胫骨衬垫3的底部设有卡槽1a1,而胫骨平台1设有凸齿3b,其也能实现第二胫骨衬垫3与胫骨平台1的卡合连接。在另外的一些实施例中,第二胫骨衬垫3还可以通过其它方式与胫骨平台1形成可拆卸连接,如通过卡扣或销钉等方式连接,本发明对此不限。
进一步的,所述胫骨平台1于所述安装面1a的区域与所述第一胫骨衬垫2的远端面之一设有安装孔1a2,另一设有与所述安装孔1a2相匹配的安装柱2b;所述安装柱2b的轴线与所述安装孔1a2的轴线重合于所述第一轴线2bc,所述安装柱2b围绕所述第一轴线2bc可转动地插设于所述安装孔1a2中。请 参考图2至图4,并结合图7,在一个示范性的实施例中,胫骨平台1于所述安装面1a的区域设有安装孔1a2,而相对的,第一胫骨衬垫2的底部(即远端面)设有安装柱2b,该安装柱2b的外轮廓尺寸略微小于安装孔1a2的内尺寸,以便于安装柱2b能插设于安装孔1a2中并能形成转动。安装柱2b的轴线重合于第一轴线2bc,如此配置,第一胫骨衬垫2能够以第一轴线2bc为中心相对胫骨平台1进行转动,且保持第一凹面2a相对第一轴线2bc为同心转动而非偏心转动。图9a~图9d示意了安装柱2b和安装孔1a2的多种形式,其中,图9a示意了圆柱形的安装柱2b和安装孔1a2,图9b示意了半球形的安装柱2b和安装孔1a2,图9c示意了凹凸形的安装柱2b和安装孔1a2,图9d示意了锥台形的安装柱2b和安装孔1a2,以上多种形式均能满足安装柱2b和安装孔1a2的装配需求,使得安装孔1a2能够限定安装柱2b的径向和轴向的自由度,而保留两者之间的周向自由度。需要说明的,图9a~图9d所示的安装柱2b和安装孔1a2的形式仅为若干示意,安装柱2b和安装孔1a2的形式不限于图9a~图9d所示,其还可以是其它形式,如燕尾形(Σ形)或锥形等。可以理解的,在其它的一些实施例中,第一胫骨衬垫2的底部设有安装孔1a2,而相对的,胫骨平台1于所述安装面1a的区域设有安装柱2b,其也能实现第一胫骨衬垫2相对于胫骨平台1的转动连接。较佳的,安装柱2b与所述安装孔1a2均为圆柱形,其安装方便,结构简单。可选的,所述第一胫骨衬垫2的横截面为圆形,当第一胫骨衬垫2相对胫骨平台1产生转动时,避免与第二胫骨衬垫3发生碰擦。
进一步的,本发明还提供一种膝关节假体,其包括股骨髁假体和如上所述的胫骨假体,所述股骨髁假体包括内侧髁和外侧髁,所述第一胫骨衬垫对应于所述内侧髁,所述第二胫骨衬垫对应于所述外侧髁,当所述股骨髁假体与所述胫骨假体相对屈曲运动时,所述内侧髁与所述第一胫骨衬垫相对转动的同时,所述第一胫骨衬垫与所述胫骨平台相对转动;所述外侧髁在所述第二胫骨衬垫上滚动的同时,所述第二胫骨衬垫与所述胫骨平台保持相对静止。由于膝关节假体包括如上所述的胫骨假体,其也具有上述胫骨假体所带来的有益效果,而本领域技术人员可根据现有技术对膝关节假体中的股骨髁假体 进行合适地配置,此处不再赘述。
综上,本发明提供的胫骨假体与膝关节假体中,胫骨假体包括胫骨平台、第一胫骨衬垫以及第二胫骨衬垫,所述胫骨平台的的近端面具有安装面;所述第一胫骨衬垫围绕第一轴线可转动地设置于所述安装面上,所述安装面的法向与所述第一轴线的夹角在0°~5°的范围内,所述第一胫骨衬垫具有以所述第一轴线为中心的第一凹面,所述第一凹面朝向远端凹陷;所述第二胫骨衬垫设置于所述胫骨平台上,所述第二胫骨衬垫具有第二凹面,所述第二凹面沿平行于所述安装面的弧形轨迹线延伸,所述弧形轨迹线的圆心位于所述第一轴线上,所述第二凹面朝向远端凹陷;所述第一胫骨衬垫和所述第二胫骨衬垫相互独立地布置,且所述第一胫骨衬垫位于所述第二胫骨衬垫的内侧。如此配置,设置对应于内外侧髁独立的两个胫骨衬垫,其中第一胫骨衬垫对应于内侧髁,第二胫骨衬垫对应于外侧髁,第一胫骨衬垫与胫骨平台相对可转动,第二胫骨衬垫则与胫骨平台保持相对静止,保证外侧髁的相对稳定。这样在股骨髁与胫骨假体间进行内侧轴旋转运动时,能实现内侧髁的双重轴向转动(内侧髁与第一胫骨衬垫相对转动,以及第一胫骨衬垫与胫骨平台相对转动),从而减少胫骨假体磨损的风险。
上述描述仅是对本发明较佳实施例的描述,并非对本发明范围的任何限定,本发明领域的普通技术人员根据上述揭示内容做的任何变更、修饰,均属于权利要求书的保护范围。

Claims (10)

  1. 一种胫骨假体,其特征在于,包括:
    胫骨平台,所述胫骨平台的近端面具有安装面;
    第一胫骨衬垫,所述第一胫骨衬垫围绕第一轴线可转动地设置于所述安装面上,所述安装面的法向与所述第一轴线的夹角在0°~5°的范围内,所述第一胫骨衬垫具有以所述第一轴线为中心的第一凹面,所述第一凹面朝向远端凹陷;以及
    第二胫骨衬垫,所述第二胫骨衬垫设置于所述胫骨平台上,所述第二胫骨衬垫具有第二凹面,所述第二凹面沿平行于所述安装面的弧形轨迹线延伸,所述弧形轨迹线的圆心位于所述第一轴线上,所述第二凹面朝向远端凹陷;
    所述第一胫骨衬垫和所述第二胫骨衬垫相互独立地布置,且所述第一胫骨衬垫位于所述第二胫骨衬垫的内侧。
  2. 根据权利要求1所述的胫骨假体,其特征在于,所述第二胫骨衬垫与所述胫骨平台为可拆卸地连接。
  3. 根据权利要求2所述的胫骨假体,其特征在于,所述第二胫骨衬垫的远端面与所述胫骨平台的近端面之一设有卡槽,另一设有与所述卡槽相匹配的凸齿,所述第二胫骨衬垫与所述胫骨平台通过所述卡槽与所述凸齿沿垂直于所述第一轴线的方向相卡合而装配连接。
  4. 根据权利要求3所述的胫骨假体,其特征在于,所述卡槽为锥形槽或矩形槽。
  5. 根据权利要求1所述的胫骨假体,其特征在于,所述胫骨平台的安装面与所述第一胫骨衬垫的远端面之一设有安装孔,另一设有与所述安装孔相匹配的安装柱;所述安装柱的轴线与所述安装孔的轴线重合于所述第一轴线,所述安装柱围绕所述第一轴线可转动地插设于所述安装孔中。
  6. 根据权利要求5所述的胫骨假体,其特征在于,所述安装柱与所述安装孔均为圆柱形。
  7. 根据权利要求1所述的胫骨假体,其特征在于,所述胫骨平台包括立 柱,所述立柱的轴线平行于所述第一轴线,且所述立柱设置于所述胫骨平台的远端侧。
  8. 根据权利要求1所述的胫骨假体,其特征在于,所述第一凹面为球面,所述球面的球心位于所述第一轴线上。
  9. 根据权利要求1所述的胫骨假体,其特征在于,所述第一胫骨衬垫的横截面为圆形。
  10. 一种膝关节假体,其特征在于,包括股骨髁假体和根据权利要求1-9中任一项所述的胫骨假体,所述股骨髁假体包括内侧髁和外侧髁,所述胫骨假体的第一胫骨衬垫对应于所述内侧髁,所述胫骨假体的第二胫骨衬垫对应于所述外侧髁,当所述股骨髁假体与所述胫骨假体作相对屈曲运动时,所述内侧髁与所述第一胫骨衬垫相对转动的同时,所述第一胫骨衬垫与所述胫骨平台相对转动;所述外侧髁在所述第二胫骨衬垫上滚动的同时,所述第二胫骨衬垫与所述胫骨平台相对静止。
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