CN100574726C - Artificial joint prosthesis with local gradient pore structure and preparation method thereof - Google Patents

Abstract

An artificial joint prosthesis with a local gradient pore structure and a preparation method thereof belong to the field of biomedical engineering. The prosthesis of the present invention includes: a prosthesis handle, a gradient pore structure body, the gradient pore structure body is welded to a preset position of the prosthesis handle, and the gradient pore structure body includes: a metal titanium plate, a first metal titanium ball, and a second metal titanium ball 1. The third metal titanium ball, the three metal titanium balls are sintered on the metal titanium plate in layers from small to large in size. In the invention, the spherical metal powder is sintered on the metal titanium plate in layers through a sintering process to obtain a gradient pore structure, and then welded on the predetermined position of the joint prosthesis. The present invention can protect the prosthetic stem from high-temperature heat treatment process, maintain good high-strength mechanical properties, obtain a suitable gradient pore structure, provide space for the growth of cells and tissues, and promote the growth of new bone tissue and host bone. Combined, the biological fixation of the prosthesis can be realized, which can be applied to the repair of joint damage in clinical practice.

Description

Artificial joint prosthesis with local gradient pore structure and preparation method thereof

technical field

The invention relates to an orthopedic implant prosthesis in the technical field of biomedical engineering and a preparation method thereof, in particular to an artificial joint prosthesis with a local gradient pore structure and a preparation method thereof.

Background technique

Artificial joint replacement is a common surgical method for clinical treatment of joint injuries caused by trauma or disease, and the clinical application effect is good. The mechanical and biological properties of artificial joints are the key factors affecting its clinical effect in repairing joint damage. Joint prostheses made of metal materials such as stainless steel, titanium and their alloys usually have good mechanical properties, and after being implanted in the human body, they can meet the force requirements of patients during daily activities. Although titanium and its alloys have good corrosion resistance and biocompatibility. However, the prostheses of various titanium and its alloy materials currently used clinically still have serious defects in biological performance, such as: large metal prostheses cannot grow well with soft and hard tissues of the human body. In order to overcome this problem, the part of the prosthesis is tried to be made into a porous structure in order to provide space for the growth of human cells and tissues, promote the growth of new tissues and the prosthesis, and achieve biological fixation.

Plasma spraying technology is a method commonly used to locally prepare porous structures on the surface of prostheses. This technology uses a plasma arc as a heat source to heat the metal material to a molten or semi-molten state, and sprays it on the surface of the pretreated workpiece at high speed to form a firmly attached surface layer, which belongs to the high-temperature heat treatment technology. During the process of spraying metal powder on the surface of the prosthesis, due to the effect of high temperature, the mechanical properties of the prosthesis itself will be affected, resulting in a decrease in the mechanical properties of the prosthesis, and it is prone to breakage after replacement into the human body. Therefore, on the premise of not reducing the mechanical properties of the prosthesis itself, it is of great engineering significance and clinical significance to construct a local pore structure on the surface of the prosthesis to provide space for the growth of cells and tissues, and to promote the growth of new tissues and the prosthesis. Value.

After searching the existing technical documents, it was found that the application number: 87101194.8, the publication number: CN1033559, and the name: "Manufacturing Technology of Artificial Joints with Porous Layer Sintered Surface". A manufacturing process in which the prosthetic stem is also subject to high temperature, thereby affecting the mechanical properties of the prosthetic stem itself; the porous structure artificial joint prosthesis developed by the world-renowned Zimmer company (www.zimmer.com ), is a local porous structure artificial joint prosthesis prepared by plasma spraying technology, the mechanical properties of the prosthesis stem will be affected by high temperature and will be reduced.

Contents of the invention

The purpose of the present invention is to address the deficiencies of the prior art, to provide an artificial joint prosthesis with a local gradient pore structure and a preparation method thereof, so as to overcome the problem of damage to the mechanical properties of the prosthesis itself in the process of preparing the surface porous structure of the artificial joint prosthesis. Insufficient, it provides space for the growth of human cells and tissues, promotes the growth of new tissue and joint prosthesis, and realizes the biological fixation of the prosthesis.

The present invention is achieved through the following technical solutions:

The artificial joint prosthesis with a local gradient pore structure according to the present invention comprises: a prosthesis handle and a gradient pore structure, the gradient pore structure is welded to a preset position of the prosthesis handle to form an artificial joint prosthesis with a local gradient pore structure.

The gradient pore structure includes: a metal titanium plate, a first metal titanium sphere, a second metal titanium sphere, and a third metal titanium sphere. The first metal titanium balls, the second metal titanium balls and the third metal titanium balls are sintered on the metal titanium plate in stages in order of size from small to large, wherein the first metal titanium ball with the smallest size is in contact with the metal titanium plate.

The first metal titanium ball has a diameter of 100-200 μm.

The diameter of the second metal titanium ball is 200-300 μm.

The third metal titanium ball has a diameter of 300-500 μm.

The gradient pore structure has a porosity of 20-50%.

The metal titanium plate is titanium and its alloy plate.

The metal titanium ball is spherical titanium and its alloy powder.

In the above-mentioned prosthesis, the function of the prosthesis handle is to bear the force, and the function of the gradient pore structure is to provide space for the growth of cells and tissues to realize the biological fixation of the prosthesis.

The preparation method of the local gradient pore structure artificial joint prosthesis of the present invention comprises the following steps:

In the first step, three kinds of diameters of spherical titanium and its alloy powders are successively laid on a titanium and its alloy plates, among which the spherical titanium and its alloy powders with the smallest diameter are directly spread on a titanium and its alloy plates, and spread for 1~ 2 layers, then lay medium-diameter titanium and its alloy powder on the smallest-diameter spherical titanium and its alloy powder layer, lay 1 to 2 layers, and finally lay a layer of medium-diameter titanium and its alloy powder layer with the largest diameter Spherical titanium and its alloy powder;

The smallest diameter spherical titanium and its alloy powder have a diameter of 100-200 μm.

The medium-diameter titanium and its alloy powders have a diameter of 200-300 μm.

The spherical titanium and its alloy powder with the largest diameter have a diameter of 300-500 μm.

The titanium and its alloy plates have a length of 30-50 mm, a width of 20-30 mm, and a thickness of 3-5 mm.

In the second step, put the above-mentioned titanium and its alloy plates covered with spherical titanium and its alloy powder into a vacuum sintering furnace for sintering. Titanium and its alloy plates with spherical powder are applied with pressure, kept warm and kept under pressure, and then the furnace temperature is cooled to room temperature to obtain a titanium and its alloy plates with surface gradient pore structure;

The sintering furnace has a vacuum degree of 1×10 ^-3 Pa.

The speed of the temperature rise is 5°C/min-10°C/min.

The applied pressure ranges from 2Mpa to 5Mpa.

The time for the heat preservation and pressure holding is 1h-2h.

The third step is to use laser welding technology to weld the titanium and its alloy plates with surface gradient pore structure on the predetermined position on the joint prosthesis to form an artificial joint prosthesis with high-strength mechanical properties and local surface gradient porous structure.

Although the local porous structure on the surface of the artificial joint prosthesis prepared by plasma spraying technology can provide space for the growth of cells and tissues, the biological fixation of the prosthesis can be realized. However, due to the effect of high temperature and the high-speed impact of metal powder in a molten or semi-molten state, the mechanical properties of the joint prosthesis itself are affected, reducing the original high-strength mechanical properties of the prosthesis. The artificial joint prosthesis with local gradient pore structure prepared by the present invention not only has a good pore structure, can provide space for the growth of cells and tissues, and realize the biological fixation of the prosthesis, but also well protects the original height of the prosthesis itself. strength mechanical properties.

The present invention adopts a step-by-step manufacturing process, which separates the high-temperature sintering process from the assembly process, and first sinters spherical metal powders of different sizes on the metal titanium plate in a layered manner through the high-temperature sintering process to form a component with a gradient pore structure. Then, using laser welding technology, on the premise of not damaging the mechanical properties of the prosthesis itself, the prepared gradient pore structure components are welded to the predetermined parts of the joint prosthesis to form an artificial joint with high-strength mechanical properties and local gradient pore structure The prosthesis can be applied to the repair of joint damage clinically.

Description of drawings

Fig. 1 is a structural representation of the present invention

Figure 2 is a schematic diagram of the gradient pore structure

Detailed ways

The embodiments of the present invention are described in detail below in conjunction with the accompanying drawings: the following embodiments are implemented on the premise of the technical solutions of the present invention, and detailed implementation methods and specific operating procedures are provided, but the protection scope of the present invention is not limited to the following the described embodiment.

As shown in Figure 1, the prosthesis in the following embodiments includes: a prosthesis handle 1, a gradient pore structure 2, and the gradient pore structure 2 is welded to the preset position of the prosthesis handle 1 to form an artificial joint with a local gradient pore structure Prosthesis.

As shown in Figure 2, the gradient pore structure 2 in the following embodiment includes: a metal titanium plate 3, a first metal titanium ball 4 with a size of 100-200 μm, a second metal titanium ball 5 with a size of 200-300 μm, a size of The third metal titanium ball 6 is 300-500 μm. Three metal titanium balls 4, 5 and 6 are sintered on the metal titanium plate 3 in layers to form a gradient pore structure 2 with a porosity of 20-50%.

An example of the method for preparing the artificial joint prosthesis with a local gradient pore structure is given below in detail.

Example 1

First, spread the spherical titanium powder with a diameter of 100 μm on a titanium plate with a length of 30 mm, a width of 20 mm, and a thickness of 3 mm, and spread 3 layers, and then spread 3 layers of spherical titanium powder with a diameter of 200 μm, and finally spread a layer of titanium powder with a diameter of 300 μm spherical titanium powder; put the above-mentioned titanium plate covered with spherical titanium powder into a vacuum sintering furnace for high-temperature sintering. The vacuum degree of the sintering furnace is 1×10 ^-3 Pa, and the furnace temperature is room temperature. 1200°C, the heating rate is 5°C/min. During the sintering process, a pressure of 5 MPa is applied to the titanium plate covered with spherical powder, and the heat preservation and pressure are maintained for 2 hours. After that, the furnace is cooled to room temperature to obtain a surface gradient pore structure. Titanium plate; using laser welding technology, the above-mentioned titanium plate with gradient pore structure on the surface is welded to a predetermined position on the artificial joint prosthesis to form an artificial joint prosthesis with a local gradient pore structure. Example 1 corresponds to a porosity (calculated value) of 32%.

Example 2

First, spread the spherical titanium powder with a diameter of 200 μm on a titanium plate with a length of 50 mm, a width of 40 mm, and a thickness of 5 mm, and spread one layer, and then spread another layer of spherical titanium powder with a diameter of 300 μm, and finally spread a layer of titanium powder with a diameter of 500 μm spherical titanium powder; put the above-mentioned titanium plate covered with spherical titanium powder into a vacuum sintering furnace for high-temperature sintering. The vacuum degree of the sintering furnace is 1×10 ^-3 Pa, and the furnace temperature is room temperature. 1400°C, the heating rate is 10°C/min. During the sintering process, a pressure of 2 MPa is applied to the titanium plate covered with spherical powder, and the heat preservation and pressure holding are carried out for 1 hour. After that, the furnace temperature is cooled to room temperature to obtain a surface gradient pore structure. Titanium plate; using laser welding technology, the above-mentioned titanium plate with gradient pore structure on the surface is welded to a predetermined position on the artificial joint prosthesis to form an artificial joint prosthesis with a local gradient pore structure. Example 2 corresponds to a porosity (calculated value) of 23%.

Example 3

First, spread the spherical titanium powder with a diameter of 150 μm on a titanium plate with a length of 40 mm, a width of 30 mm, and a thickness of 4 mm, and spread 2 layers, then spread 2 layers of spherical titanium powder with a diameter of 250 μm, and finally spread a layer of titanium powder with a diameter of 400 μm spherical titanium powder; put the above-mentioned titanium plate covered with spherical titanium powder into a vacuum sintering furnace for high-temperature sintering. The vacuum degree of the sintering furnace is 1×10 ^-3 Pa, and the furnace temperature is room temperature. 1300°C, the heating rate is 7.5°C/min. During the sintering process, a pressure of 1.5MPa is applied to the titanium plate covered with spherical powder, and the heat preservation and pressure are maintained for 1.5h. After that, the furnace temperature is cooled to room temperature to obtain a surface gradient. A titanium plate with a pore structure; using laser welding technology, the above-mentioned titanium plate with a surface gradient pore structure is welded to a predetermined position on the artificial joint prosthesis to form an artificial joint prosthesis with a local gradient pore structure. Example 3 corresponds to a porosity (calculated value) of 28%.

Claims (10)

1, a kind of partial gradient pore space structure artificial arthrosis prosthesis is characterized in that, comprising: prosthese handle, gradient pore structured body, gradient pore structured body are welded on the default position of prosthese handle, wherein:

Described gradient pore structured body comprises: metallic titanium plate, the first Titanium ball, the second Titanium ball, the 3rd Titanium ball, the first Titanium ball, the second Titanium ball, the 3rd Titanium ball size are ascending, and with different levels sintering is on metallic titanium plate, and wherein the first Titanium ball of size minimum contacts with metallic titanium plate.

2, partial gradient pore space structure artificial arthrosis prosthesis according to claim 1 is characterized in that, the described first Titanium ball, its diameter are 100-200 μ m.

3, partial gradient pore space structure artificial arthrosis prosthesis according to claim 1 is characterized in that, the described second Titanium ball, its diameter are 200-300 μ m.

4, partial gradient pore space structure artificial arthrosis prosthesis according to claim 1 is characterized in that, described the 3rd Titanium ball, its diameter are 300-500 μ m.

5, partial gradient pore space structure artificial arthrosis prosthesis according to claim 1 is characterized in that, described gradient pore structured body, and its porosity is at 20-50%.

6, a kind of preparation method of partial gradient pore space structure artificial arthrosis prosthesis according to claim 1 is characterized in that, comprises the steps:

The first step, on a titanium and alloy sheets thereof, lay the spherical titanium and the alloy powder thereof of three kinds of diameters successively, wherein the spherical titanium of minimum diameter and alloy powder thereof directly are tiled on a titanium and the alloy sheets thereof, spread 1～2 layer, then, on the spherical titanium of minimum diameter and alloy powder layer thereof, lay the titanium and the alloy powder thereof of intermediate diameters, spread 1～2 layer, at last at the titanium of intermediate diameters and the spherical titanium and the alloy powder thereof of alloy powder layer upper berth one deck diameter maximum thereof;

Second step, above-mentioned titanium and the alloy sheets thereof that is covered with spherical titanium and alloy powder thereof inserted vacuum sintering furnace, carry out sintering, charging temperature is a room temperature, furnace temperature is warming up to 1200-1400 ℃, exerts pressure to titanium that is covered with spherical powder and alloy sheets thereof in the sintering process, insulation, pressurize, furnace temperature be cooled to room temperature, obtain a kind of titanium and alloy sheets thereof of surface graded pore structure thereafter;

The 3rd step, utilize laser welding technology, the titanium of above-mentioned surface graded pore structure and alloy sheets thereof are welded on precalculated position on the articular prosthesis, form partial gradient pore space structure artificial arthrosis prosthesis.

7, the preparation method of partial gradient pore space structure artificial arthrosis prosthesis according to claim 6 is characterized in that, in the first step, the spherical titanium and the alloy powder thereof of described minimum diameter, its diameter are 100～200 μ m; The titanium of described intermediate diameters and alloy powder thereof, its diameter are 200-300 μ m; The spherical titanium and the alloy powder thereof of described diameter maximum, its diameter are 300～500 μ m.

8, according to the preparation method of claim 6 or 7 described partial gradient pore space structure artificial arthrosis prosthesis, it is characterized in that, in the first step, described titanium and alloy sheets thereof, its long 30～50mm, wide 20～30mm, thickness 3～5mm.

9, the preparation method of partial gradient pore space structure artificial arthrosis prosthesis according to claim 6 is characterized in that, in second step, and described sintering furnace, its vacuum is 1 * 10 ^-3Pa; Described intensification, its speed are 5 ℃/min-10 ℃/min.

10, according to the preparation method of claim 6 or 9 described partial gradient pore space structure artificial arthrosis prosthesis, it is characterized in that, in second step, described exerting pressure, its pressure limit is 2Mpa-5Mpa; Described insulation, pressurize, its time is 1h-2h.

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