CN113209381A

CN113209381A - Artificial knee joint cuboid condyle and preparation method thereof

Info

Publication number: CN113209381A
Application number: CN202110443487.0A
Authority: CN
Inventors: 王爱国; 王恺威; 徐小卉; 韩坤原
Original assignee: Jiangsu Yisong Medical Technology Co ltd
Current assignee: Jiangsu Yisong Medical Technology Co ltd
Priority date: 2021-04-23
Filing date: 2021-04-23
Publication date: 2021-08-06

Abstract

The invention discloses a cuboid condyle of an artificial knee joint and a preparation method thereof, wherein the cuboid condyle of the artificial knee joint comprises a cuboid condyle body, a friction layer arranged on the surface of one side of the cuboid condyle body, and a biological fixing layer arranged on the surface of the other side of the cuboid condyle body; the cuboid condyle body is of a curved surface thin shell structure, an opening and an inner cavity communicated with the opening are formed in the curved surface thin shell structure, the biological fixing layer is arranged on the wall of the inner cavity, and the biological fixing layer is a porous structure layer; the cuboid condyle body is a titanium metal body, or a titanium alloy body, or a tantalum-base alloy body; the friction layer on the cuboid condyle body is a cobalt-chromium-molybdenum alloy friction layer. The invention adopts titanium metal as the body of the cuboid condyle, greatly reduces the rigidity of the cuboid condyle through the change of the material, reduces the risk of stress shielding and solves the problem that the traditional cuboid condyle has overlarge elastic modulus and is easy to generate stress shielding on biological fixation with host bones.

Description

Artificial knee joint cuboid condyle and preparation method thereof

Technical Field

The invention relates to an orthopedic implant in the medical field, in particular to a cuboid condyle of a composite metal material artificial knee joint and a preparation method thereof.

Background

The artificial knee joint replacement prosthesis and the host bone can be fixed by bone cement or can be biologically fixed by non-bone cement. One of the core components of the knee prosthesis is the cuboid condyle, the inner surface of which typically contains a bio-fixating coating such as a titanium or titanium alloy coating, a tantalum or tantalum alloy coating, a hydroxyapatite coating (HA for short), or the like. The body of the cuboid condyle, and in particular the friction surface thereof, is usually composed of a wear-resistant CoCrMo (cobalt chromium molybdenum) material or a ceramic material or coating. Materials such as titanium, tantalum, HA and the like which have better biocompatibility with host bones cannot be used as friction surfaces due to poor wear resistance.

The traditional cuboid condyle taking cobalt-chromium-molybdenum alloy as a body has the following defects in biological fixation: 1. the elasticity modulus of the cobalt-chromium-molybdenum alloy is more than 2 times of that of the titanium alloy, so that the problem of stress shielding is easily caused on biological fixation with host bones, and the osteoporosis of the host bones is caused;

2. the combination between the cobalt-chromium-molybdenum alloy body and the titanium, tantalum or HA coating can be realized only by sintering or thermal spraying, and the problem that the fatigue strength of the matrix is reduced due to high-temperature sintering or the risk of falling off of a spraying interface exists;

3. the combination of the cobalt-chromium-molybdenum alloy body and the metal trabecular bone surface with the bionic porous structure at the forefront of orthopedics at present has no proper solution, so that the application of the titanium or tantalum metal porous trabecular bone structure and the cuboid condyle is seriously hindered.

Therefore, a new technical solution is needed to solve the above problems.

Disclosure of Invention

The invention aims to provide a cuboid condyle of an artificial knee joint and a preparation method thereof, which are used for solving the problems of stress shielding, peeling of a biological fixed coating and other risks of a biological fixed cuboid taking a cobalt-chromium-molybdenum alloy as a body. The material of the body of the cuboid condyle provided by the invention is titanium or tantalum-based alloy, the material of the friction layer of the cuboid condyle is cobalt-chromium-molybdenum alloy, the biological fixing layer of the body of the cuboid condyle is a porous structure with the thickness not less than 0.5mm, the porosity of the porous structure is not less than 30%, and no obvious physical or chemical interface exists between the porous structure and the nonporous cuboid condyle body. The cuboid condyle presented in the present disclosure may address one or more of the problems in the prior art. The technical scheme of the invention is specifically explained as follows:

on one hand, the invention provides a cuboid condyle of an artificial knee joint, which comprises a cuboid condyle body, a friction layer arranged on one side surface of the cuboid condyle body, and a biological fixing layer arranged on the other side surface of the cuboid condyle body; the cuboid condyle body is of a curved surface thin shell structure, an opening and an inner cavity communicated with the opening are formed in the curved surface thin shell structure, the biological fixing layer is arranged on the cavity wall of the inner cavity, and the biological fixing layer is a porous structure layer; the friction layer on the cuboid condyle body is a cobalt-chromium-molybdenum alloy friction layer.

In a further aspect of the above technical solution, the cuboid condyle body is a titanium metal body, or a titanium alloy body, or a tantalum-based alloy body; the porous structure layer is a porous titanium alloy structure layer, the thickness of the porous structure layer is not less than 0.5mm, the porosity of the porous structure layer is not less than 30%, and the porous structure layer and the cuboid condyle body are integrally formed; the thickness of the friction layer is not less than 0.5mm and not more than 5 mm.

Furthermore, the surface of one side of the curved surface thin shell structure is recessed towards the center of the curved surface thin shell structure to form the inner cavity, the surface of the curved surface thin shell structure, which is opposite to the inner cavity, protrudes towards the direction away from the center of the curved surface thin shell structure to form a convex surface, and the friction layer is arranged on the convex surface; the average thickness of the friction layer is not less than 0.05mm and not more than 3.0 mm.

On the other hand, the invention also provides a preparation method of the cuboid condyle of the artificial knee joint, which comprises the following steps: preparing a cuboid condyle body: the cuboid condyle body is manufactured by selective area melting 3D printing through laser or electron beams, the manufactured cuboid condyle body is of a curved surface shell structure, and an opening, an inner cavity communicated with the opening and a convex surface opposite to the inner cavity are formed in the curved surface shell structure;

preparing a biological fixing layer: forming the biological fixing layer on the wall of the cavity of the cuboid condyle body, wherein the biological fixing layer is prepared by 3D printing and is a porous structure layer;

preparing a friction layer: forming the friction layer on the convex surface of the cuboid condyle body.

In a further aspect of the above technical solution, the friction layer is formed by 3D printing using laser or electron beam selective fusing or powder spraying melting, or the friction layer is formed by thermal spraying.

Further, the friction layer is prepared by thermally spraying cobalt-chromium-molybdenum alloy on the convex surface of the cuboid condyle body.

Further, the preparation method further comprises the following steps: and carrying out heat treatment on the prepared cuboid condyle body and/or the biological fixing layer and/or the friction layer so as to eliminate residual stress on the cuboid condyle body and/or the biological fixing layer and/or the friction layer and free metal particles on the surface.

Further, the preparation method further comprises the following steps: machining the prepared cuboid condyle body and/or the biological fixation layer and/or the friction layer so that the cuboid condyle body and/or the biological fixation layer and/or the friction layer meet a dimensional design criterion and/or a surface finish.

Further, the machining process includes grinding and polishing.

Further, the cuboid condyle body and the biological fixing layer are integrally formed through 3D printing.

Compared with the prior art, the invention has one or more of the following beneficial effects:

1. the invention provides a cuboid condyle of an artificial knee joint, which adopts titanium as a body of the cuboid condyle, and can greatly reduce the rigidity of the cuboid condyle through the change of materials, thereby reducing the risk of stress shielding and solving the problems that the elasticity modulus of the cuboid condyle of a cobalt-chromium-molybdenum alloy body is too large and the stress shielding is easily generated on biological fixation with host bones in the prior art.

2. According to the invention, the titanium metal is adopted to manufacture the porous structure of the biological fixing layer, and the prepared biological fixing layer is fixed with host bones to promote bone ingrowth and improve the biological fixing stability of the cuboid condyles.

3. The invention adopts cobalt-chromium-molybdenum alloy to manufacture the friction layer, thereby overcoming the defect of poor wear resistance of the existing titanium-based alloy of the cuboid condyle.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present invention, and other drawings can be obtained by those skilled in the art without creative efforts.

FIG. 1 is a schematic structural view of the friction layer of the present invention in one embodiment;

FIG. 2 is a schematic view of the cuboid condyle and the biological fixation layer according to the present invention in one embodiment;

FIG. 3 is a schematic view of the cuboid condyle made according to the present invention in one embodiment.

Wherein, 100-the condyle of cuboid prosthesis; 110-the condyle body of cuboid; 120-a friction layer; 130-a biological fixing layer; 131-holes.

Detailed Description

The technical solutions of the embodiments of the present invention will be described clearly and completely with reference to the accompanying drawings of the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

In the description of the present invention, it is to be understood that the terms "upper", "lower", "top", "bottom", "inner", "outer", and the like, indicate orientations or positional relationships based on those shown in the drawings, and are used only for convenience in describing the present invention and for simplicity in description, and do not indicate or imply that the referenced devices or elements must have a particular orientation, be constructed and operated in a particular orientation, and thus, are not to be construed as limiting the present invention. In the description of the present invention, "a plurality" means two or more unless specifically defined otherwise.

In the present invention, unless otherwise expressly stated or limited, the terms "mounted," "connected," "secured," and the like are to be construed broadly and can, for example, be fixedly connected, detachably connected, or integrally formed; can be mechanically or electrically connected; either directly or indirectly through intervening media, either internally or in any other relationship. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.

The gist of the present invention will be further explained below with reference to the accompanying drawings and examples.

Example 1:

in order to solve the defects, the invention provides the cuboid condyle of the artificial knee joint made of the composite metal material, and the cuboid condyle of the artificial knee joint can be used as a prosthesis and applied to a host body to solve the defects of the traditional cuboid condyle. Referring to fig. 1-3, the cuboid condyle of the artificial knee joint (which is a cuboid condyle prosthesis 100, see fig. 3) according to the present invention includes a cuboid condyle body 110, a friction layer 120 disposed on one side surface of the cuboid condyle body 110, and a biological fixing layer 130 disposed on the other side surface of the cuboid condyle body 110, referring to fig. 3, the cuboid condyle body 110 is a curved thin shell structure, an opening is formed on the curved thin shell structure, and an inner cavity communicated with the opening is formed on the wall of the inner cavity, the biological fixing layer 130 is disposed on the wall of the inner cavity, the biological fixing layer 130 is a porous structure layer, referring to fig. 3, a plurality of holes 131 on the biological fixing layer 130 are only schematically shown in fig. 3 for reference, and are not intended to limit the present application.

In order to fundamentally solve the defects of the traditional cuboid condyle, the invention researches and replaces materials for manufacturing the cuboid condyle, the cuboid condyle body can be a titanium metal body, a titanium alloy body or a tantalum-based alloy body, and the prosthesis made of the materials has certain advantages compared with the traditional cuboid condyle, which are related to the characteristics of the materials. The friction layer on the cuboid condyle body is a cobalt-chromium-molybdenum alloy friction layer, so that the defect of poor wear resistance of the traditional titanium-based alloy friction surface of the cuboid condyle is overcome.

The cuboid condyle structure is improved in material, related structural parameters of the cuboid condyle are also improved, the porous structure layer is a porous titanium alloy structure layer, the thickness of the porous structure layer is not less than 0.5mm, the porosity of the porous structure layer is not less than 30%, and the porous structure layer and the cuboid condyle body 110 are integrally formed; the friction layer 120 has a thickness of not less than 0.5mm and not more than 5 mm.

With continued reference to fig. 3, the cuboid condyle body 110 of the present invention is a curved thin shell structure, a surface of one side of the curved thin shell structure is recessed towards a central position of the curved thin shell structure to form the inner cavity, a surface of the curved thin shell structure opposite to the inner cavity is raised towards a direction away from the central position of the curved thin shell structure to form a convex surface, and the friction layer 120 is disposed on the convex surface. In one embodiment, the average thickness of the friction layer 120 is not less than 0.05mm and not greater than 3.0 mm.

According to the cuboid condyle of the artificial knee joint provided by the invention, titanium is adopted as the body of the cuboid condyle, and the rigidity of the cuboid condyle can be greatly reduced through the change of the material, so that the risk of stress shielding is reduced, and the problem that the elasticity modulus of the cuboid condyle of a cobalt-chromium-molybdenum alloy body is too large and the stress shielding is easily generated on biological fixation with host bones in the prior art is solved. According to the invention, the titanium metal is adopted to manufacture the porous structure of the biological fixing layer, and the prepared biological fixing layer is fixed with host bones to promote bone ingrowth and improve the biological fixing stability of the cuboid condyles. The invention adopts cobalt-chromium-molybdenum alloy to manufacture the friction layer, thereby overcoming the defect of poor wear resistance of the existing titanium-based alloy of the cuboid condyle.

Example 2:

the invention also provides a preparation method of the cuboid condyle of the artificial knee joint, which comprises the following steps:

step 1, preparing a cuboid condyle body 110: the cuboid condyle body 110 is manufactured by selective area melting 3D printing through laser or electron beams, the manufactured cuboid condyle body 110 is of a curved surface thin shell structure, and an opening, an inner cavity communicated with the opening and a convex surface opposite to the inner cavity are formed in the curved surface thin shell structure;

step 2, preparing the biological fixing layer 130: forming the biological fixing layer 130 on the wall of the cavity of the cuboid condyle body 110, wherein the biological fixing layer 130 is prepared by 3D printing, and the prepared biological fixing layer 130 is a porous structure layer;

step 3, preparing the friction layer 120: forming the friction layer 120 on the convex surface of the cuboid condyle body 110 to obtain the cuboid condyle prosthesis 100.

It should be noted that, in the step of preparing the cuboid condyle, step 1 and step 2 may not be sequentially performed, and the preparation of the cuboid condyle body 110 and the preparation of the biological fixing layer 130 may be performed simultaneously, that is, the cuboid condyle body 110 and the biological fixing layer 130 are integrally formed by 3D printing in a 3D printer.

In one embodiment, the friction layer 120 may be prepared by fusing or powder-jet fusing 3D printing with a laser or electron beam.

In another embodiment, the friction layer 120 may be formed by thermal spraying, i.e., the friction layer 120 may be formed by thermal spraying of a cobalt-chromium-molybdenum alloy on the convex surface of the cuboid condyle body 110.

In one embodiment, the friction layer 120 is made to have a thickness no less than 0.05mm and no greater than 5mm, and the optimal thickness (which may be understood as an average thickness) of the friction layer 120 may be made to be between 1mm and 3 mm.

In one embodiment, the method for preparing the cuboid condyle further comprises: the prepared cuboid condyle body 110 and/or the biological fixing layer 130 and/or the friction layer 120 are subjected to heat treatment to eliminate residual stress on the cuboid condyle body 110 and/or the biological fixing layer 130 and/or the friction layer 120 and free metal particles on the surface. The internal stress is inevitably generated in the metal forming process, the internal stress can be eliminated through heat treatment, free metal particles are also inevitably generated in the metal forming process, and the free metal particles on the surface can be cleaned through the heat treatment, so that the two purposes are achieved. The heat treatment mode can be determined according to the actual forming process and the metal material, and is the same action principle as the heat treatment in the general metal forging process.

In one embodiment, the method for preparing the cuboid condyle further comprises: machining the prepared cuboid condyle body 110 and/or the biological fixing layer 130 and/or the friction layer 120 so that the cuboid condyle body 110 and/or the biological fixing layer 130 and/or the friction layer 120 meet dimensional design standards and/or surface finish, such as size reduction and roughness improvement of the prepared cuboid condyle by grinding and polishing.

Example 3:

on the basis of the embodiment 2, the invention also provides a preparation method of the cuboid condyle of the artificial knee joint, which comprises the following steps:

the cuboid condyle titanium body can be prepared by a laser or electron beam 3D printing technology, the porous biological fixing layer 130 and the nonporous cuboid condyle body 110 can be formed in one step by a 3D printing method, and the combination between the cobalt-chromium-molybdenum friction surface and the titanium body can be completed by a thermal spraying technology.

The thickness of the thermal spraying is not less than 0.05mm and not more than 3.0 mm.

In the manufacturing method, residual stress in the metal and free metal particles on the surface can be eliminated in a heat treatment mode.

In the manufacturing method, the final design size and surface finish of the cuboid condyle can be realized through grinding, polishing and other machining methods.

Example 4:

on the basis of the embodiment 2, the invention also provides another preparation method of the cuboid condyle of the artificial knee joint, which comprises the following specific steps:

the titanium body of the cuboid condyle is formed by a laser or electron beam 3D printing technology. A layer of porous structure with the thickness not less than 0.5mm is formed on the surface of the inner wall of the inner cavity of the titanium metal body, and the porous structure and the non-porous structure are formed in one step through 3D printing. The bonding between the cobalt chromium molybdenum friction layer 120 of the cuboid condyle and the titanium metal body may be accomplished by laser or electron beam 3D printing techniques. The molding steps of the cuboid condyle are as follows: firstly, preparing a titanium metal body with a porous structure at one time by a selective laser or electron beam melting 3D printing technology; secondly, the titanium metal body is placed into a fuse wire or powder spraying melting 3D printer which is rapidly formed by laser or electron beams, and the friction layer 120 of the cobalt-chromium-molybdenum alloy is directly printed on the outer surface of the titanium metal body. The average thickness of the cobalt chromium molybdenum friction layer 120 is not less than 0.5mm and not more than 3.0 mm.

In conclusion, the invention provides a cuboid condyle of a composite metal artificial knee joint and a preparation method thereof, the cuboid condyle and the preparation method thereof adopt titanium as a body of the cuboid condyle, and the rigidity of the cuboid condyle can be greatly reduced through the change of the material, so that the risk of stress shielding is reduced, and the problems that the elasticity modulus of the cuboid condyle of a cobalt-chromium-molybdenum alloy body is too large and the stress shielding is easily generated in the biological fixation with host bones in the prior art are solved; the invention also adopts titanium metal to manufacture the porous structure of the biological fixing layer, and the prepared biological fixing layer is fixed with host bones to promote bone ingrowth and improve the biological fixing stability of the cuboid condyles; the invention also adopts cobalt-chromium-molybdenum alloy to manufacture the friction layer, thereby overcoming the defect of poor wear resistance of the existing titanium-based alloy of the cuboid condyle.

In the description herein, references to the description of the term "one embodiment," "some embodiments," "an example," "a specific example" or "some examples" or the like are intended to mean that a particular feature, structure, material, or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of the invention. In this specification, the schematic representations of the terms used above are not necessarily intended to refer to the same embodiment or example. Furthermore, the particular features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples. Furthermore, various embodiments or examples described in this specification can be combined and combined by one skilled in the art.

While embodiments of the present invention have been shown and described above, it is to be understood that the above embodiments are exemplary and not to be construed as limiting the present invention, and that changes, modifications and variations may be made therein by those of ordinary skill in the art within the scope of the present invention.

Claims

1. A cuboid condyle of an artificial knee joint is characterized by comprising a cuboid condyle body (110), a friction layer (120) arranged on one side surface of the cuboid condyle body (110), and a biological fixing layer (130) arranged on the other side surface of the cuboid condyle body (110);

the cuboid condyle body (110) is of a curved surface thin shell structure, an opening and an inner cavity communicated with the opening are formed in the curved surface thin shell structure, the biological fixing layer (130) is arranged on the wall of the inner cavity, and the biological fixing layer (130) is a porous structure layer;

the cuboid condyle body (110) is a titanium metal body, or a titanium alloy body, or a tantalum-base alloy body;

the friction layer (120) on the cuboid condyle body (110) is a cobalt-chromium-molybdenum alloy friction layer (120).

2. The cuboid condyle artificial knee joint of claim 1, wherein the cuboid condyle artificial knee joint is formed by a cuboid,

the porous structure layer is a porous titanium alloy structure layer, the thickness of the porous structure layer is not less than 0.5mm, the porosity of the porous structure layer is not less than 30%, and the porous structure layer and the cuboid condyle body (110) are integrally formed;

the thickness of the friction layer (120) is not less than 0.5mm and not more than 5 mm.

3. The cuboid condyle artificial knee joint of claim 2, wherein the cuboid condyle artificial knee joint is formed by a cuboid,

the surface of one side of the curved surface thin shell structure is sunken towards the central position of the curved surface thin shell structure to form the inner cavity, the surface, opposite to the inner cavity, of the curved surface thin shell structure is protruded towards the direction far away from the central position of the curved surface thin shell structure to form a convex surface, and the friction layer (120) is arranged on the convex surface;

the average thickness of the friction layer (120) is not less than 0.05mm and not more than 3.0 mm.

4. A preparation method of a cuboid condyle of an artificial knee joint is characterized by comprising the following steps:

preparing a cuboid condyle body (110): the cuboid condyle body (110) is manufactured by selective area melting 3D printing through laser or electron beams, the manufactured cuboid condyle body (110) is of a curved surface shell structure, and an opening, an inner cavity communicated with the opening and a convex surface opposite to the inner cavity are formed in the curved surface shell structure;

preparation of the biological fixing layer (130): forming the biological fixing layer (130) on the wall of the cavity of the cuboid condyle body (110), wherein the biological fixing layer (130) is prepared by 3D printing, and the prepared biological fixing layer (130) is a porous structure layer;

preparation of the friction layer (120): forming the friction layer (120) on the convex surface of the cuboid condyle body (110).

5. The method for preparing the cuboid condyle of the artificial knee joint according to claim 4, wherein the friction layer (120) is prepared by fusing or powder-spraying 3D printing through laser or electron beam selective area, or the friction layer (120) is prepared through a thermal spraying technology;

and thermally spraying a cobalt-chromium-molybdenum alloy on the convex surface of the cuboid condyle body (110) to obtain the friction layer (120).

6. The method for preparing the cuboid condyle of the artificial knee joint according to claim 5, further comprising: performing heat treatment on the prepared cuboid condyle body (110) and/or the biological fixing layer (130) and/or the friction layer (120) to eliminate residual stress on the cuboid condyle body (110) and/or the biological fixing layer (130) and/or the friction layer (120) and free metal particles on the surface.

7. The method for preparing the cuboid condyle of the artificial knee joint according to claim 5, further comprising: machining the prepared cuboid condyle body (110) and/or the biological fixation layer (130) and/or the friction layer (120) so that the cuboid condyle body (110) and/or the biological fixation layer (130) and/or the friction layer (120) meet a dimensional design criterion and/or a surface finish.

8. The method of claim 7, wherein the machining process comprises grinding and polishing.

9. The method for preparing the cuboid condyle of the artificial knee joint according to claim 4, wherein the cuboid condyle body and the biological fixing layer are integrally formed through 3D printing.