CN119819946B - Method for preparing degradable magnesium alloy vascular stent by laser powder bed melting - Google Patents
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Abstract
The invention is suitable for the technical field of additive manufacturing, and provides a method for preparing a degradable magnesium alloy vascular stent by melting a laser powder bed, which comprises the following steps of weighing 1-3% of Sr, 0.5-1.5% of Zr, 0.2-1% of Bi, 0.5-2% of Si, 0.1-0.5% of Ti and the balance of Mg according to the mass percentage, smelting to form uniform liquid alloy, spraying the liquid alloy by using high-pressure argon gas, cooling to form powder particles, and screening to obtain magnesium alloy powder; the method comprises the steps of designing the wall thickness and pore structure of a bracket according to the size and blood flow characteristics of a blood vessel, paving magnesium alloy powder on a substrate, designing a laser scanning path according to the structure of the bracket, adopting interlayer scanning to prepare the magnesium alloy bracket, polishing the magnesium alloy bracket, cleaning, drying, carrying out fluorination treatment on the bracket, and cleaning and drying. The vascular stent with good biodegradation characteristic is successfully prepared on the premise of not affecting the biocompatibility and mechanical strength of the magnesium alloy material.
Description
Technical Field
The invention belongs to the technical field of additive manufacturing, and particularly relates to a method for preparing a degradable magnesium alloy vascular stent by melting a laser powder bed.
Background
For cardiovascular diseases such as coronary heart disease, hypertension and the like, the vascular stent is used as an effective treatment means in treatment. The main materials of the traditional vascular stent are metal materials such as stainless steel, cobalt alloy and the like, and the materials have higher mechanical strength, but long-term complications such as thrombosis, restenosis in the stent, chronic inflammatory reaction inside and outside the stent and the like possibly exist in vivo, so in order to reduce the problems, the degradable metal materials, particularly magnesium alloy, are gradually becoming the important research points of vascular stent materials in recent years. The magnesium alloy material has excellent biocompatibility, degradability and good mechanical property, particularly in the interaction with human tissues, the degradation process of magnesium can effectively reduce adverse reactions possibly brought by the long-term existence of a metal stent in vivo, however, the degradation rate of the magnesium alloy material in vivo is faster, the problem limits the application of the magnesium alloy material in vascular stents, and in order to balance the degradation rate and the mechanical property, researchers have largely explored the aspects of the composition, microstructure and surface treatment of the magnesium alloy, and a plurality of methods are provided, but the methods still have a plurality of defects in practical application.
The laser powder bed melting (LPBF) technology is used as an additive manufacturing process, has wide application prospect in the medical field, can melt metal powder layer by layer on a metal powder bed by precisely controlling the heat energy input of laser beams to finally obtain a three-dimensional structure with a complex geometric shape, has the remarkable advantages that compared with a traditional processing method, compared with the prior art, the LPBF technology has the advantages that the high-precision manufacturing is realized, the LPBF technology can realize the micron-sized processing precision, the microstructure and the porosity of a stent can be precisely controlled, the strict requirements of the vascular stent on the dimensional precision and the mechanical property are met, the material utilization rate is high, the unmelted powder can be recycled due to the adoption of powder materials, the material waste is less, the cost is relatively low, and the LPBF technology can manufacture the complex geometric structure, such as porous, gradual change pore, internal channel and the like, and has important significance in the aspects of improving the biocompatibility of the vascular stent, promoting the growth of vascular endothelial cells and reducing the complications. Therefore, the laser powder bed melting technology has great application potential in the preparation of the magnesium alloy vascular stent, and can effectively solve the problems of complex structure and performance optimization which are difficult to realize by the traditional manufacturing method.
In the early stage, the magnesium alloy material cannot be widely applied in the field of vascular stents due to high degradation rate and lower mechanical strength, the mechanical property and biocompatibility of the magnesium alloy are gradually improved by adjusting components, microstructure and surface treatment method of the magnesium alloy in the prior art, for example, zinc, calcium, rare earth elements and the like are added, the mechanical property and corrosion behavior of the magnesium alloy can be improved, the degradation rate can be effectively controlled by a surface coating (such as a polymer coating, a phosphating coating and the like), and the stability of the vascular stent is improved, for example, patent application CN108014379A, CN104189963A, CN114904052A, CN116370709A, CN103418035A, international patent WO2023151343 (A1), WO2015172664 (A1), european patent EP3144018 (A4) and the like. At present, the main method for manufacturing the magnesium alloy vascular stent is to firstly prepare a magnesium alloy microtube, then carry out laser cutting and laser engraving on the microtube, cut and engrave a magnesium alloy material by utilizing the high energy density of laser, and finally obtain a reticular tubule, such as patent applications of CN109433841A, CN105964716A, CN101249286A and the like, but the vascular stent obtained by the method has the problems that the surface quality is uneven, local overheating or ablation phenomenon is easy to occur, the surface quality is not ideal, the yield is low and the like, compared with the problems that the additive manufacturing technology provides higher flexibility and manufacturing precision, such as patent applications of CN 101856723A, CN106620837A and the like, the molding method for preparing the magnesium alloy vascular stent by utilizing the additive manufacturing technology is disclosed. Nevertheless, the degradable magnesium alloy vascular stent prepared by the existing additive manufacturing technology still lacks reliable data support in terms of mechanical property, degradation rate and biocompatibility, and at present, the magnesium alloy stent prepared by laser powder bed melting still faces the problem of too fast degradation rate, which may lead to early failure of the stent and incapability of effectively supporting blood vessels, and meanwhile, the problem of insufficient mechanical strength is also existed, which cannot meet the high-strength requirement required by the vascular stent.
Disclosure of Invention
The embodiment of the invention aims to provide a method for preparing a degradable magnesium alloy vascular stent by melting a laser powder bed, which aims to solve the problems in the prior art.
The embodiment of the invention is realized in such a way that the method for preparing the degradable magnesium alloy vascular stent by melting the laser powder bed comprises the following steps:
the preparation method comprises the steps of weighing 1-3% of Sr, 0.5-1.5% of Zr, 0.2-1% of Bi, 0.5-2% of Si, 0.1-0.5% of Ti and the balance of Mg according to the mass percentage, smelting to form uniform liquid alloy, spraying the liquid alloy by using high-pressure argon, cooling to form powder particles, and screening to obtain magnesium alloy powder;
Designing a bracket structure, namely designing the wall thickness and the pore structure of the bracket according to the size and the blood flow characteristics of a blood vessel;
melting a laser powder bed, namely paving magnesium alloy powder on a substrate, designing a laser scanning path according to the structure of the bracket, and adopting interlayer scanning to prepare the magnesium alloy bracket;
and (3) surface treatment, namely polishing the magnesium alloy bracket, cleaning and drying the bracket, carrying out fluorination treatment on the bracket, and cleaning and drying the bracket.
Preferably, in the step of preparing the magnesium alloy powder, the smelting temperature is 700-750 ℃, and the particle size of the magnesium alloy powder obtained by screening is 30-60 mu m.
Preferably, in the step of designing the scaffold structure, the porosity of the scaffold is 80-90%, and the wall thickness of the scaffold is 0.3-0.5 mm.
Preferably, in the step of melting the laser powder bed, the magnesium alloy powder is laid on the substrate to a thickness of 30-50 μm.
Preferably, in the step of laser powder bed melting, the interlayer scan is specifically rotated 67 ° per printed layer, with a layer thickness of 20-30 μm.
Preferably, in the step of melting the laser powder bed, the heating temperature of the substrate is 400-450 ℃.
Preferably, the melting parameters of the laser powder bed are that the laser power is 50-100 w, the scanning speed is 200-600 mm/s, and the scanning interval is 80-100 mu m;
The parameters of the outer contour are that the laser power is 40-50 w, and the scanning speed is 400-600 mm/s.
Preferably, in the step of surface treatment, the polishing treatment is specifically that a magnesium alloy bracket is polished by adopting a phosphoric acid solution, and the time is 300-350 s.
Preferably, in the step of surface treatment, the fluorination treatment is specifically carried out by immersing the magnesium alloy bracket in hydrofluoric acid for 12-24 h, vibrating by using a shaking table to uniformly fluorinate, forming a MgF 2 film layer on the surface of the magnesium alloy bracket, placing the magnesium alloy bracket in supersaturated hydroxyapatite solution, and vibrating by using the shaking table for 24-48 h.
Another object of the embodiment of the present invention is to provide a degradable magnesium alloy vascular stent, which is prepared by the above method.
According to the method for preparing the degradable magnesium alloy vascular stent by melting the laser powder bed, provided by the embodiment of the invention, excellent mechanical properties and ideal controllable degradation rate are obtained by reasonably designing alloy components, controlling process parameters in a laser printing process and optimizing a surface treatment technology, the vascular stent with good biodegradation characteristics can be successfully prepared on the premise of not affecting the biocompatibility and mechanical strength of a magnesium alloy material, the porosity and structural morphology of the stent are accurately controlled by the laser powder bed melting process, the compressive strength, the degradability and the biocompatibility of the stent are further improved, and compared with the traditional stent preparation method, the stent prepared by the embodiment of the invention can be stably degraded in vivo, and meanwhile, the irritation to the inner wall of a blood vessel is small, the risks of inflammatory reaction and foreign body rejection are reduced, so that the clinical application effect after implantation is improved.
Drawings
Fig. 1 is a design drawing of a magnesium alloy vascular stent provided in embodiment 1 of the present invention;
FIG. 2 is a morphology diagram of a degradable magnesium alloy vascular stent prepared in example 1 of the present invention;
FIG. 3 shows the mechanical properties of the degradable magnesium alloy vascular stent prepared in example 3 of the present invention;
FIG. 4 shows the corrosion resistance of the degradable magnesium alloy vascular stent prepared in example 3 of the present invention.
FIG. 5 shows the cell viability of the degradable magnesium alloy vascular stent prepared in example 3 of the present invention;
FIG. 6 shows the result of the hemolysis ratio of the degradable magnesium alloy vascular stent prepared in example 3 of the present invention.
Detailed Description
The present invention will be described in further detail with reference to the drawings and examples, in order to make the objects, technical solutions and advantages of the present invention more apparent. It should be understood that the specific embodiments described herein are for purposes of illustration only and are not intended to limit the scope of the invention.
A method for preparing a degradable magnesium alloy vascular stent by melting a laser powder bed comprises the following steps:
Firstly, preparing magnesium alloy powder, wherein the magnesium alloy consists of magnesium, strontium, zirconium, bismuth, silicon and titanium elements in percentage by mass (Wt/%), wherein strontium (Sr) is 1-3, zirconium (Zr) is 0.5-1.5, bismuth (Bi) is 0.2-1, silicon (Si) is 0.5-2, titanium (Ti) is 0.1-0.5, the balance of magnesium (Mg) is complemented, the adopted magnesium, strontium, zirconium, bismuth, silicon and titanium are all more than 99.99%, smelting is carried out in an electric furnace, the smelting temperature is generally controlled to be 700-750 ℃, the alloy components are fully dissolved and form uniform liquid alloy at the temperature, a proper amount of degasifier is added in the smelting process to remove gas impurities in the solution, the alloy is prevented from reacting with oxygen in the air through furnace gas protection, then the liquid alloy is sprayed by high-pressure argon, fine powder particles are formed through rapid cooling, and the magnesium alloy powder with the particle size ranging from 30-60 mu m is selected;
Secondly, designing a bracket structure, namely, designing the wall thickness and the pore structure of the bracket according to the size and the blood flow characteristics of the blood vessel, wherein the wall thickness is 0.3-0.5 mm, the porosity is 80-90 percent so as to promote blood circulation and provide enough biodegradation space, and the included angle between a supporting unit and the axial direction is not more than 45 degrees;
The third step, melting by a laser powder bed, namely uniformly paving the prepared magnesium alloy powder on a substrate, ensuring the uniformity of a magnesium alloy layer, controlling the thickness to be 30-50 mu m, designing a laser scanning path according to the structure of a bracket, adopting a strategy of rotating 67 DEG for each printed layer to perform interlayer scanning, wherein the thickness is 20-30 mu m so as to ensure the uniform melting and compactness of the material, adopting ultra-high purity argon for protection during the melting process of the laser powder bed, and keeping the heating temperature of the substrate at 400-450 ℃, wherein the melting process parameters of the laser powder bed are that the laser power is 50-100 w, the scanning speed is 200-600 mm/s and the scanning interval is 80-100 mu m, and in addition, the outer contour adopts the process of scanning the laser power of 40-50w and the scanning speed is 400-600 mm/s for one time, thereby further improving the printing quality and precision;
And fourthly, carrying out surface treatment, namely polishing the magnesium alloy bracket by using a 5% phosphoric acid solution for 300 seconds, then fully oscillating and cleaning the polished bracket in absolute ethyl alcohol, then fully drying the bracket in a drying box, then soaking the magnesium alloy bracket in 35% hydrofluoric acid for 12-24 h, oscillating by using a shaking table to uniformly fluorinate the bracket so as to form a MgF 2 film layer on the surface of the bracket, then placing the bracket in a supersaturated hydroxyapatite solution, carrying out oscillating treatment for 24-48 h, cleaning by using deionized water and absolute ethyl alcohol, drying, and enhancing the corrosion resistance and the biocompatibility of the bracket by surface treatment to delay the degradation rate of the magnesium alloy so as to ensure the quality and the function of the final bracket.
Specific implementations of the invention are described in detail below in connection with specific embodiments.
Example 1, a method for preparing a degradable magnesium alloy vascular stent by laser powder bed melting, comprising the following steps:
Firstly, preparing magnesium alloy powder, namely, the magnesium alloy comprises, by mass percent (Wt/%) of strontium (Sr) 1, zirconium (Zr) 0.5, bismuth (Bi) 1, silicon (Si) 0.5, titanium (Ti) 0.5 and the balance of magnesium (Mg), placing the magnesium alloy powder into an electric furnace for smelting, controlling the smelting temperature to be 700-750 ℃, then using high-pressure argon to spray liquid alloy, rapidly cooling to form fine powder particles, and screening the magnesium alloy powder with the particle size range of 30-60 mu m;
Secondly, designing a support structure, wherein the wall thickness of the support is 0.5 mm, the porosity is 85%, and the included angle between a supporting unit and the axial direction is not more than 45 degrees, as shown in figure 1;
Step three, melting by a laser powder bed, namely uniformly paving the prepared magnesium alloy powder on a substrate, controlling the thickness to be 30-50 mu m, designing a laser scanning path according to the structure of a bracket, adopting a strategy of rotating 67 degrees for each layer to perform interlayer scanning, wherein the thickness of the layer is 30 mu m, adopting ultra-pure argon for protection during the melting of the laser powder bed, and keeping the heating temperature of the substrate at 420 ℃, wherein the melting process parameters of the laser powder bed are that the laser power is 60w, the scanning speed is 200 mm/s and the scanning interval is 80 mu m, and in addition, the outer contour adopts a process of scanning by the laser power of 40 w and the scanning speed is 400 mm/s;
And fourthly, carrying out surface treatment, namely polishing the magnesium alloy bracket by using a 5% phosphoric acid solution for 300 s%, then fully oscillating and cleaning the polished bracket in absolute ethyl alcohol, then fully drying the bracket in a drying box, then soaking the magnesium alloy bracket in 35% hydrofluoric acid for 15 h, oscillating by using a shaking table to uniformly fluorinate the bracket so as to form a MgF 2 film layer on the surface of the bracket, then placing the bracket in a supersaturated hydroxyapatite solution, oscillating by using the shaking table for 48 h, cleaning by using deionized water and absolute ethyl alcohol, and drying the bracket to obtain the degradable magnesium alloy vascular bracket, wherein the appearance of the degradable magnesium alloy vascular bracket is shown in figure 2.
Example 2 is different from example 1 only in that the magnesium alloy composition in mass percent (Wt/%) is strontium (Sr) 2, zirconium (Zr) 0.5, bismuth (Bi) 1, silicon (Si) 1, titanium (Ti) 0.25, the balance being magnesium (Mg), and the other steps are the same as those of example 1.
Example 3 is different from example 1 only in that the magnesium alloy composition in mass percent (Wt/%) is strontium (Sr) 3, zirconium (Zr) 1, bismuth (Bi) 0.5, silicon (Si) 2, titanium (Ti) 0.1, the balance being magnesium (Mg), and the other steps are the same as those of example 1.
Example 4 is different from example 1 only in that the magnesium alloy composition in mass percent (Wt/%) is strontium (Sr) 1, zirconium (Zr) 1, bismuth (Bi) 0.5, silicon (Si) 0.5, titanium (Ti) 0.5, and the balance magnesium (Mg) is the same as in example 1.
Example 5 is different from example 1 only in that the magnesium alloy composition in mass percent (Wt/%) is strontium (Sr) 2, zirconium (Zr) 1.5, bismuth (Bi) 0.2, silicon (Si) 1, titanium (Ti) 0.25, and the balance magnesium (Mg) is the same as in example 1.
Example 6 is different from example 1 only in that the magnesium alloy composition in mass percent (Wt/%) is strontium (Sr) 3, zirconium (Zr) 1.5, bismuth (Bi) 0.2, silicon (Si) 2, titanium (Ti) 0.1, and the balance magnesium (Mg) is the same as in example 1.
Performance test:
The samples prepared in the example 3 are tested for mechanical property, corrosion resistance and biocompatibility, the tensile strength and elongation rate are shown in the graph 3, the degradation speed in the simulated blood environment is shown in the graph 4, the cytotoxicity test results of the example 3 and the surface untreated vascular stent are shown in the graph 5, and the hemolysis test results are shown in the graph 6;
the samples prepared in other examples were then tested separately, and the results are summarized in table 1:
TABLE 1
;
According to Table 1, it can be seen that the sample prepared by the embodiment of the invention has tensile strength of 300-322 MPa, elongation of 17-22.4%, good mechanical property, degradation rate in simulated blood environment of 0.4-0.5mm/y, good corrosion resistance, slow degradation in vivo, cell survival rate of 96-99% after soaking for 7 days, hemolysis rate of 2.8-3.2% after incubation for 1 hour at 37 ℃ in blood, and excellent biocompatibility.
In summary, the method for preparing the degradable magnesium alloy vascular stent by melting the laser powder bed provided by the embodiment of the invention obtains the vascular stent with excellent mechanical property, controllable degradation rate and good biocompatibility by designing the components of the magnesium alloy material and controlling the technological parameters and surface treatment in the laser printing process, and solves the following problems:
The problem of insufficient mechanical properties of the magnesium alloy vascular stent, which is possible to occur in the traditional magnesium alloy vascular stent, is not enough to provide sufficient supporting force, so that the vascular stent can be broken or excessively deformed after implantation, and the alloy components and microstructure of the magnesium alloy can be accurately controlled, the mechanical properties of the magnesium alloy vascular stent are optimized, and the stability and the effectiveness of the stent after implantation are ensured by the laser powder bed melting technology provided by the embodiment of the invention;
The method comprises the steps of accurately regulating and controlling the microstructure of the magnesium alloy through a laser powder bed melting technology, optimizing the degradation rate through surface treatment, and synchronizing the degradation rate with a vascular repair process, so that the problem of excessively fast or excessively slow degradation is avoided;
The surface of the magnesium alloy stent may have uneven roughness and corrosiveness, which affects the combination of the stent and the vessel wall, resulting in poor biocompatibility and even initiation of immune reaction or inflammation, and the embodiment of the invention optimizes the surface roughness of the stent and adopts proper post-treatment process, the vascular stent is beneficial to the attachment and growth of vascular endothelium, and the combination of the stent and the vascular wall is improved, so that the biocompatibility of the vascular stent is improved, the immune response and inflammatory response are reduced, and the risk of secondary operation is reduced.
The foregoing description of the preferred embodiments of the invention is not intended to be limiting, but rather is intended to cover all modifications, equivalents, and alternatives falling within the spirit and principles of the invention.
Claims (8)
1. The method for preparing the degradable magnesium alloy vascular stent by melting the laser powder bed is characterized by comprising the following steps of:
the preparation method comprises the steps of weighing 1-3% of Sr, 0.5-1.5% of Zr, 0.2-1% of Bi, 0.5-2% of Si, 0.1-0.5% of Ti and the balance of Mg according to the mass percentage, smelting to form uniform liquid alloy, spraying the liquid alloy by using high-pressure argon, cooling to form powder particles, and screening to obtain magnesium alloy powder;
Designing a bracket structure, namely designing the wall thickness and the pore structure of the bracket according to the size and the blood flow characteristics of a blood vessel;
melting a laser powder bed, namely paving magnesium alloy powder on a substrate, designing a laser scanning path according to the structure of the bracket, and adopting interlayer scanning to prepare the magnesium alloy bracket;
Surface treatment, namely polishing a magnesium alloy bracket, cleaning and drying the bracket, carrying out fluorination treatment on the bracket, and cleaning and drying the bracket;
in the step of designing the stent structure, the porosity of the stent is 80-90%, and the wall thickness of the stent is 0.3-0.5 mm;
The parameters of the laser powder bed melting are that the laser power is 50-100 w, the scanning speed is 200-600 mm/s, and the scanning interval is 80-100 mu m;
The parameters of the outer contour are that the laser power is 40-50 w, and the scanning speed is 400-600 mm/s.
2. The method for preparing the degradable magnesium alloy vascular stent by melting a laser powder bed according to claim 1, wherein in the step of preparing the magnesium alloy powder, the melting temperature is 700-750 ℃, and the particle size of the magnesium alloy powder obtained by screening is 30-60 μm.
3. The method for preparing a degradable magnesium alloy vascular stent by melting a laser powder bed according to claim 1, wherein in the step of melting the laser powder bed, the magnesium alloy powder is paved on a substrate, and the thickness is 30-50 μm.
4. The method for preparing a degradable magnesium alloy vascular stent by melting a laser powder bed according to claim 1, wherein in the step of melting the laser powder bed, the interlayer scanning is performed in a mode of rotating 67 degrees for each printed layer, and the layer thickness is 20-30 μm.
5. The method for preparing a degradable magnesium alloy vascular stent by melting a laser powder bed according to claim 1, wherein in the step of melting the laser powder bed, the heating temperature of the substrate is 400-450 ℃.
6. The method for preparing the degradable magnesium alloy vascular stent by melting a laser powder bed according to claim 1, wherein in the step of surface treatment, the polishing treatment is specifically to polish the magnesium alloy vascular stent by adopting a phosphoric acid solution, and the time is 300-350 s.
7. The method for preparing the degradable magnesium alloy vascular stent by melting the laser powder bed according to claim 1, wherein in the step of surface treatment, the magnesium alloy stent is soaked in hydrofluoric acid for 12-24 h, and is vibrated by a shaking table to uniformly fluorinate, a MgF 2 film layer is formed on the surface of the magnesium alloy stent, and then the magnesium alloy stent is placed in a supersaturated hydroxyapatite solution, and is vibrated by the shaking table for 24-48 h.
8. A degradable magnesium alloy vascular stent, which is prepared by the method of any one of claims 1 to 7.
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| Mg-Sr-Zr医用镁合金微观组织与腐蚀性能研究;李江波;《中国优秀硕士学位论文全文数据库 工程科技Ⅰ辑》;20160815;第1-65页 * |
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