WO2024088120A1

WO2024088120A1 - Tibial tray prosthesis

Info

Publication number: WO2024088120A1
Application number: PCT/CN2023/125113
Authority: WO
Inventors: 王俊文; 欧毅; 张清
Original assignee: 宽岳新晟实医疗科技(上海)有限公司
Priority date: 2022-10-25
Filing date: 2023-10-18
Publication date: 2024-05-02
Also published as: CN115624418A

Abstract

A tibial tray prosthesis, comprising a tibial tray platform (1) and a tibial tray stem (2). The tibial tray platform (1) has a proximal end surface (11) facing the tibia and a distal end surface (12) arranged opposite the proximal end surface (11), and the tibial tray stem (2) is fixedly connected to the proximal end surface (11) of the tibial tray platform (1). A porous 3D printed metal structure (10) is further provided on the proximal end surface (11) of the tibial tray platform (1), and the porous 3D printed metal structure (10) has a pore intercept length of 200 μm to 500 μm and a porosity of 50% to 80%, which reduces the stress shielding effect of the tibial tray prosthesis so as to mitigate problems such as reduced strength and delayed healing of bone caused by existing prostheses.

Description

Tibial tray prosthesis

This patent application claims the priority of the following Chinese patent applications:

Submission date: October 25, 2022; Application number: 202211309092.2; Invention name: A tibial tray prosthesis;

The above-referenced application is incorporated herein by reference in its entirety.

Technical Field

The invention relates to the technical field of medical devices, and in particular to a tibial tray prosthesis.

Background technique

Artificial knee replacement is a plastic surgery that uses artificial biological materials to replace diseased joints in the human body and restore the normal physiological function of the knee joint. Currently, the common tibial tray prostheses on the market are mostly machined from titanium alloy forgings. They are heavy, simple in structure, and mostly fixed with bone cement. When used by patients, wear particles will enter the joint cavity, which can easily cause aseptic loosening problems in the later stage. In addition, in order to promote postoperative recovery, a biological coating will be set on the knee joint frame to promote bone growth. Existing biological coatings are usually hydroxyapatite coatings, but there is a stress shielding effect between the hydroxyapatite coating and the knee prosthesis, which will reduce the strength of the bones and delay healing.

In addition, the existing tibial tray prosthesis is fixed in the human body mainly through the fixation between the tibial tray and the tibial pad, but the tibial tray prosthesis will twist in the tibia during use, which will cause the structural bearing capacity between the tibial tray prosthesis and the tibia to be weak. After long-term use, it will aggravate the wear of the tibia, which will not only affect the service life of the tibial tray, but also may cause complications.

Summary of the invention

The purpose of the present invention is to provide a tibial tray prosthesis to improve the problem that the existing biological coating may cause strength reduction, delayed healing and the like on bones.

To achieve the above purpose, the technical solution adopted by the present invention is as follows:

A tibial tray prosthesis comprises a tibial tray platform and a fixing assembly, wherein the tibial tray platform has a proximal surface facing the tibia and a distal surface arranged opposite to the proximal surface, and the fixing assembly is fixedly connected to the proximal surface of the tibial tray platform; the proximal surface of the tibial tray platform is also provided with a porous 3D printed metal The porous 3D printed metal structure has a pore intercept of 200 μm to 500 μm and a porosity of 50% to 80%.

In one embodiment, a porous 3D printed metal structure is also provided on a side of the fixation component close to the tibial tray platform.

In one embodiment, the thickness of the porous 3D printed metal structure is not less than 1 mm.

In one embodiment, the fixing assembly is a tibial tray column disposed on the proximal surface of the tibial tray platform, the tibial tray column has a column body extending away from the distal surface, and a plurality of wing plates are disposed on the peripheral side of the column body.

In one embodiment, the side wall of the wing plate on the thickness side includes a first side wall that is fitted and fixed to the proximal surface of the tibial support platform, a second side wall that is fitted and fixed to the outer peripheral wall of the column, and a third side wall connecting the first side wall and the second side wall, and the vertical distance between the third side wall and the column gradually decreases from the connection with the column toward the free end.

In one embodiment, the column is a columnar structure that gradually decreases from the connection point to the free end.

In one embodiment, the fixing assembly further comprises a plurality of bosses disposed on the proximal surface of the tibial tray platform, and the plurality of bosses are distributed beside the tibial tray column.

In one embodiment, a porous 3D printed metal structure is also provided on a side of the boss close to the tibial tray platform.

In one embodiment, a plurality of inwardly concave recesses are disposed on the side surface of the boss, and the plurality of recesses are distributed in the circumferential direction of the boss.

In one embodiment, the free end of the boss is a pointed insertion portion.

In one embodiment, the tibial tray platform and the fixing component are integrally manufactured by 3D printing, or the fixing component is formed on the tibial tray platform by 3D printing.

The present invention adopts the above technical solution, which has the beneficial effect that the proximal surface of the tibial tray prosthesis provided by the present invention is provided with a porous 3D printed metal structure, and the pore intercept of the porous 3D printed metal structure is 200μm-500μm, and the porosity is 50%-80%. The elastic modulus of the porous 3D printed metal structure is similar to that of human bones, which can reduce the gravitational shielding effect and is more conducive to long bones. At the same time, it can also reduce the stress shielding effect of the tibial tray prosthesis, improve the existing prosthesis caused by the reduced strength of the bone, Problems such as delayed healing.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a perspective view of a tibial tray prosthesis in one viewing direction.

FIG. 2 shows a front view of a tibial tray prosthesis.

FIG. 3 shows a perspective view of the tibial tray prosthesis in another viewing direction.

FIG. 4 shows a bottom view of the tibial tray prosthesis.

FIG. 5 shows a schematic diagram of a tibial tray post.

FIG. 6 shows a schematic diagram of a boss.

Detailed ways

The preferred embodiments of the present invention will be described in detail below in conjunction with the accompanying drawings so that the purpose, features and advantages of the present invention can be more clearly understood. It should be understood that the embodiments shown in the accompanying drawings are not intended to limit the scope of the present invention, but are only intended to illustrate the essential spirit of the technical solution of the present invention.

In the following description, certain specific details are set forth for the purpose of illustrating various disclosed embodiments to provide a thorough understanding of the various disclosed embodiments. However, those skilled in the relevant art will recognize that the embodiments may be practiced without one or more of these specific details. In other cases, well-known devices, structures, and techniques associated with the present application may not be shown or described in detail to avoid unnecessarily obscuring the description of the embodiments.

Unless the context requires otherwise, throughout the specification and claims, the word "comprise" and variations such as "include" and "have" should be construed in an open, inclusive sense, ie, should be interpreted as "including, but not limited to."

References throughout the specification to "one embodiment" or "an embodiment" indicate that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, the appearances of "in one embodiment" or "in an embodiment" in various places throughout the specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any manner in one or more embodiments.

As used in this specification and the appended claims, the singular forms "a,""an," and "the" include plural referents unless the context clearly dictates otherwise. It should be noted that the term "or" is generally used in its sense to include "and" /or" unless the context clearly states otherwise.

In the following description, in order to clearly show the structure and working mode of the present invention, many directional words will be used for description, but the words "front", "back", "left", "right", "outside", "inside", "outward", "inward", "up", "down", etc. should be understood as convenient terms and should not be understood as restrictive terms.

In addition, the terms "horizontal", "vertical", "overhanging" and the like do not mean that the components are required to be absolutely horizontal or overhanging, but can be slightly tilted. For example, "horizontal" only means that its direction is more horizontal than "vertical", and does not mean that the structure must be completely horizontal, but can be slightly tilted.

In the description of this application, it should also be noted that, unless otherwise clearly specified and limited, the terms "set", "install", "connect", and "connect" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two elements. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to specific circumstances.

As shown in Figures 1 and 2, this embodiment provides a tibial tray prosthesis, including a tibial tray platform 1 and a fixing assembly, and the fixing assembly in this embodiment includes a tibial tray column 2. Among them, the tibial tray platform 1 is plate-shaped, and has a proximal surface 11 facing the tibia and a distal surface 12 arranged opposite to the proximal surface. The middle part of the tibial tray platform 1 is provided with an avoidance groove 13 for the cruciate ligament to pass through. The outer edge of the distal surface of the tibial tray platform 1 is a snap-on protective wall 14 protruding away from the proximal surface 11, and the snap-on protective wall 14 is used to fix the tibial pad prosthesis (not shown in the figure). Preferably, there is a protruding anti-rotation block 15 in the middle part of the distal surface of the tibial tray platform 1, and the anti-rotation block 15 cooperates with the corresponding recess on the tibial pad prosthesis, which can effectively prevent the tibial pad prosthesis from rotating relative to the tibial tray prosthesis.

Referring to Figures 3 and 4, a porous 3D printed metal structure 10 is also provided on the proximal surface of the tibial support platform 1. The porous 3D printed metal structure 10 can be manufactured by a 3D printing additive manufacturing method, and has a thickness of not less than 1 mm, a pore intercept of 200 μm to 500 μm, and a porosity of 50% to 80%. The elastic modulus of the porous 3D printed metal structure 10 is similar to that of human bones, which can reduce the gravitational shielding effect, is more conducive to long bones, and improves the problems of reduced bone strength and delayed healing caused by existing prostheses.

Referring to Fig. 1-Fig. 3, tibial support column 2 is fixedly connected on the proximal surface 11 of tibial support platform 1, for inserting in the proximal medullary cavity of human tibia.Tibial support column 2 has a column 21 extending toward the tibia direction, column 21 is a cone column that gradually decreases from the connection to the free end direction, and this cone structure increases the friction between the bone, and compared with the common columnar structure, the surrounding cancellous bone is easy to accept the pressure of the structure, and the attachment growth increases the later stability.And a hemispherical body is formed on the free end of the column 21, so as to facilitate the positioning of the tibial support column 2 and to be inserted into the proximal medullary cavity, and the amount of osteotomy can also be reduced simultaneously.A plurality of wing plates 22 are provided on the peripheral side of the column 21.

In this embodiment, referring to Fig. 4, four wing plates 22 are arranged on the outer circumference of the column 21, and the four wing plates are distributed in a cross shape on the circumference of the column 21. The wing plates 22 provide a good anti-rotation effect, which is beneficial to initial and later stability.

Referring to Fig. 5, the side wall of each wing plate 22 on the thickness side includes a first side wall 221 that fits and fixes with the proximal surface of the tibial support platform 1, a second side wall 222 that fits and fixes with the peripheral wall of the column 21, and a third side wall 223 that connects the first side wall 221 and the second side wall 222. The vertical distance of the third side wall 223 from the column 21 gradually decreases from the connection with the column to the free end, that is, the wing plate 22 is a roughly triangular plate body, so as to facilitate the insertion of the tibial support column 2 into the proximal medullary cavity, and at the same time, the wing plate on the tibial support column 2 provides an anti-rotation effect to prevent the tibial prosthesis from twisting in the tibia when in use. The tibial support column 2 can be made by 3D printing, which can achieve a structure that is conducive to long bones and fixation that cannot be achieved by ordinary machining.

Referring to FIG3 , a porous 3D printed metal structure 10 is also provided on the side of the tibial support column 2 close to the tibial support platform 1. The porous 3D printed metal structure 10 on the tibial support column 2 can be partially or fully provided on the tibial support column 2 close to the side of the tibial support platform 1. This part of the porous 3D printed metal structure 10 further provides an area for bone tissue to grow into the column, provides stronger later stability, and further reduces the risk of loosening.

In this embodiment, the fixing assembly further includes a plurality of bosses 3 located on the proximal surface of the tibial tray platform 1. The plurality of bosses 3 are distributed on the side of the tibial tray column 2 so as to be able to grip the tibial tuberosity to provide auxiliary positioning and fixation and anti-rotation functions to prevent the tibial prosthesis from twisting in the tibia during use. The peripheral wall of the boss 3 is an arc shape that gradually decreases from the connection point to the free end to form a pointed structure, so as to be square. The boss 3 is inserted. Preferably, a plurality of inwardly concave recesses 31 are provided on the side of the boss 3, and the plurality of recesses 31 are roughly evenly distributed on the circumference of the boss 3 to improve the anti-rotation ability of each boss 3. The boss 3 can be made by 3D printing, which can realize a structure that is conducive to bone growth and fixation that cannot be achieved by ordinary machining.

Referring to Fig. 3, the tibial tray platform 1 in this embodiment is provided with four bosses 3, which are distributed on the tibial tray platform 1 in a roughly isosceles trapezoidal shape, and the two bosses 3 on the short side of the isosceles trapezoid are located on the side away from the avoidance groove 13. The bosses 3 distributed in this way can increase the stability of the tibial tray platform 1 fixed to the tibia.

Referring to FIG3 , a porous 3D printed metal structure 10 is also provided on the side of the boss 3 close to the tibial tray platform 1. The porous 3D printed metal structure 10 on the boss 3 can be partially or fully provided on the boss 3 close to the side of the tibial tray platform 1. This part of the porous 3D printed metal structure 10 further provides an area for bone tissue to grow into the column, provides stronger later stability, and further reduces the risk of loosening.

The porous 3D printed metal structure on the fixing component can be obtained by 3D printing, wherein the tibial tray platform and the fixing component can be manufactured by integrated 3D printing. Except for the porous 3D printed metal structure on the proximal surface of the tibial tray platform, the rest of the tibial tray platform is solid printed to ensure the strength of the tibial tray platform. The tibial tray column and boss serving as the fixing component can be columns or bosses that are all porous 3D printed metal structures, or can be solid structures that are solid printed except for the corresponding areas that are porous 3D printed metal structures.

Alternatively, the tibial tray platform can be first manufactured by machining, and then a porous 3D printed metal structure is used on the proximal surface of the tibial tray platform, and then the tibial tray column and boss are 3D manufactured as fixed components. The tibial tray column and boss can also be columns or bosses that are all porous 3D printed metal structures, or they can be solid structures with the corresponding areas being porous 3D printed metal structures and the rest being solid printed.

The preferred embodiments of the present invention have been described in detail above, but it should be understood that after reading the above teachings of the present invention, those skilled in the art may make various changes or modifications to the present invention. These equivalent forms also fall within the scope defined by the appended claims of this application.

Claims

A tibial tray prosthesis, characterized in that it includes a tibial tray platform and a fixing assembly, the tibial tray platform having a proximal surface facing the tibia and a distal surface arranged opposite to the proximal surface, the fixing assembly being fixedly connected to the proximal surface of the tibial tray platform; the proximal surface of the tibial tray platform is also provided with a porous 3D printed metal structure, and the pore intercept of the porous 3D printed metal structure is 200μm to 500μm, and the porosity is 50% to 80%.
The tibial tray prosthesis as described in claim 1 is characterized in that a porous 3D printed metal structure is also provided on a side of the fixing component close to the tibial tray platform.
The tibial tray prosthesis according to claim 1 or 2, characterized in that the thickness of the porous 3D printed metal structure is not less than 1 mm.
The tibial tray prosthesis as described in claim 1 is characterized in that the fixing component is a tibial tray column arranged on the proximal surface of the tibial tray platform, the tibial tray column has a column body extending away from the distal surface, and a plurality of wing plates are arranged on the outer peripheral side of the column body.
The tibial tray prosthesis as described in claim 4 is characterized in that the side wall of the wing plate on the thickness side includes a first side wall that is fitted and fixed to the proximal surface of the tibial tray platform, a second side wall that is fitted and fixed to the outer peripheral wall of the column, and a third side wall connecting the first side wall and the second side wall, and the vertical distance of the third side wall from the column gradually decreases from the connection with the column toward the free end.
The tibial tray prosthesis according to claim 4 is characterized in that the column is a columnar structure that gradually decreases from the connection point to the free end.
The tibial tray prosthesis as described in claim 4 is characterized in that the fixing assembly also includes a plurality of bosses arranged on the proximal surface of the tibial tray platform, and the plurality of bosses are distributed on the side of the tibial tray column.
The tibial tray prosthesis as described in claim 7 is characterized in that a porous 3D printed metal structure is also provided on the side of the boss close to the tibial tray platform.
The tibial tray prosthesis according to claim 7 is characterized in that a plurality of inwardly concave recesses are provided on the side surface of the boss, and the plurality of recesses are distributed in the circumferential direction of the boss.
The tibial tray prosthesis according to claim 7, characterized in that the free end of the boss is pointed Insertion portion.
The tibial tray prosthesis according to claim 7 is characterized in that the tibial tray platform and the fixing component are made by 3D printing as an integrated whole, or the fixing component is formed on the tibial tray platform by 3D printing.