CN112916869B - Forming method of antibacterial titanium alloy surgical implant - Google Patents
Forming method of antibacterial titanium alloy surgical implant Download PDFInfo
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- CN112916869B CN112916869B CN202110090666.0A CN202110090666A CN112916869B CN 112916869 B CN112916869 B CN 112916869B CN 202110090666 A CN202110090666 A CN 202110090666A CN 112916869 B CN112916869 B CN 112916869B
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B22—CASTING; POWDER METALLURGY
- B22F—WORKING METALLIC POWDER; MANUFACTURE OF ARTICLES FROM METALLIC POWDER; MAKING METALLIC POWDER; APPARATUS OR DEVICES SPECIALLY ADAPTED FOR METALLIC POWDER
- B22F3/00—Manufacture of workpieces or articles from metallic powder characterised by the manner of compacting or sintering; Apparatus specially adapted therefor ; Presses and furnaces
- B22F3/24—After-treatment of workpieces or articles
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B33—ADDITIVE MANUFACTURING TECHNOLOGY
- B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
- B33Y10/00—Processes of additive manufacturing
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B33—ADDITIVE MANUFACTURING TECHNOLOGY
- B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
- B33Y40/00—Auxiliary operations or equipment, e.g. for material handling
- B33Y40/20—Post-treatment, e.g. curing, coating or polishing
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B33—ADDITIVE MANUFACTURING TECHNOLOGY
- B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
- B33Y80/00—Products made by additive manufacturing
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- C—CHEMISTRY; METALLURGY
- C22—METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
- C22C—ALLOYS
- C22C14/00—Alloys based on titanium
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B22—CASTING; POWDER METALLURGY
- B22F—WORKING METALLIC POWDER; MANUFACTURE OF ARTICLES FROM METALLIC POWDER; MAKING METALLIC POWDER; APPARATUS OR DEVICES SPECIALLY ADAPTED FOR METALLIC POWDER
- B22F3/00—Manufacture of workpieces or articles from metallic powder characterised by the manner of compacting or sintering; Apparatus specially adapted therefor ; Presses and furnaces
- B22F3/24—After-treatment of workpieces or articles
- B22F2003/247—Removing material: carving, cleaning, grinding, hobbing, honing, lapping, polishing, milling, shaving, skiving, turning the surface
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02P—CLIMATE CHANGE MITIGATION TECHNOLOGIES IN THE PRODUCTION OR PROCESSING OF GOODS
- Y02P10/00—Technologies related to metal processing
- Y02P10/25—Process efficiency
Abstract
The invention discloses a molding method of an antibacterial titanium alloy surgical implant. The method selects titanium alloy containing copper and other antibacterial metal elements, adopts a wire additive manufacturing technology to manufacture a surgical implant blank with a required shape by near net forming, and then prepares surgical implant products meeting different purposes through subsequent plastic finishing and/or precise machining. The method has the characteristics of simple and feasible production process, cheap and easily available raw materials, high production efficiency, low cost and the like.
Description
Technical Field
The invention belongs to the field of biomedical metal materials and medical instruments, and particularly relates to a molding method of an antibacterial titanium alloy surgical implant, which is used for the production and application of medical instrument products for repairing and replacing human bone tissues.
Background
Titanium and titanium alloys have been widely used in the medical and health fields due to their light weight, high specific strength, low elastic modulus, corrosion resistance, and good biocompatibility, and surgical implant products for bone tissue replacement and repair such as artificial joints, dental implants, intraspinal fixation systems, intramedullary nails, and skull repair mesh plates, which are used along with patients for life, have significantly improved the quality of life of the patients. However, bacterial infection is also one of the complications of surgical implants after surgery, and microbial infection and microbial corrosion in body fluids can reduce the life of the bioimplant material, even leading to implant failure, and pose health risks and economic burden to patients. It can be seen that effective prevention and control of post-operative infections of implant materials is critical to successful clinical use of biomedical materials.
The titanium alloy surgical implant material itself has no antimicrobial function. Therefore, trying to make titanium alloy have a certain antibacterial function will make it better satisfy the clinical long-acting application, and is one of the important research directions of the current medical titanium alloy. It was found that by adding certain metallic elements to form an alloy, a corresponding medical functional effect is achieved by slow release of the metallic ions. A great deal of researches prove that copper is a metal material with good bacteriostasis, and Ti-xCu series and Ti6Al4VxCu series titanium alloys have antibacterial and antivirus performances, wherein the Ti6Al4V5Cu alloy has a killing rate of 98% on staphylococcus aureus and has obvious bone promoting function.
At present, titanium alloy surgical implants are mainly divided into three types of products, namely joint products, spinal products and wound products, wherein the products are usually manufactured by adopting raw materials such as titanium alloy plates, bars and the like and utilizing a mechanical processing (multi-shaft machine tool or numerical control machining center) method. Or firstly adopting titanium alloy die forging to process into a blank, then carrying out secondary precision processing to obtain a final product, such as a near net shaped joint blank of the die forging obtained by the artificial hip joint, and then carrying out numerical control milling processing. With the advent of advanced metal powder additive manufacturing technology in recent years, the product can also be used for preparing the surgical implant product, and personalized design and customization can be realized.
However, the above-described process has significant drawbacks or disadvantages with respect to the shaping of the product according to the invention: 1) Compared with other conventional titanium alloys, the copper-containing antibacterial titanium alloy has the advantages that the alloy strengthening effect is enhanced, and the processing difficulty is remarkably increased, so that when raw materials such as plates, bars and the like are processed, the processing power of related pressure processing equipment such as plate rolling machines, bar precision forging machines and the like is large, the equipment volume is correspondingly increased, the difficulty is higher when raw materials of thin plates (with the thickness of 1-3 mm) are produced, the processing cost is high, the quality is not easy to control, and the yield is reduced; 2) For instruments such as plate type and the like, the instruments need to be precisely cut on a large plate, then a plurality of parts are precisely machined, the working procedure is long, and raw materials are wasted; for the hip joint handle, the rod is firstly cut into a fixed size and then subjected to hot die forging, and finally subjected to precise machining, so that the multiple machining procedures and the manufacturing cost are increased.
Although the above-described products can also be used to produce a wide variety of surgical implant products using a powder additive manufacturing process, the following problems also exist: (1) The titanium alloy metal powder for 3D printing needs to adopt 10-100 micron-sized spherical powder, the current preparation method needs to adopt a plasma rotary electrode or an air atomization method, the processing period is long, the fine powder yield is low, the quality is not easy to control (inferior powder such as hollow powder, planetary powder and the like appears), and the titanium spherical powder is mainly produced by adopting expensive import equipment due to poor quality of domestic equipment and high price; (2) The powder additive manufacturing equipment is selected, so that the one-time investment cost is high, the equipment occupation is large, and the metal powder raw materials used by the method are large in one-time feeding quantity, so that the material recycling is not facilitated. (3) The use of powder 3D printing is more suitable for the processing of personalized or porous structural surgical implant devices (such as acetabular cups, etc.), while it is not economically and technically justified for the processing of most three main types of products, namely joints, spines and wounds, with internal compact and standardized structures. Therefore, the preparation method is not beneficial to the efficient and low-cost processing of the antibacterial titanium alloy surgical implant product, thereby influencing the design development and performance evaluation of the new product and the future industrialized popularization and application.
Disclosure of Invention
Aiming at the great demands, problems and defects of the prior product production and manufacture of surgical implants for repairing and replacing hard tissues of bones, the invention aims to provide a molding method of an antibacterial titanium alloy surgical implant.
According to the invention, the antibacterial titanium alloy metal wire with low price is selected as a raw material, the wire 3D printer is utilized to prepare near-net-shaped surgical implant blanks with different shapes and prefabricated holes or individuation, and then the antibacterial titanium alloy surgical implant can be manufactured rapidly, efficiently and at low cost through a subsequent finishing post-treatment process, so that the research, development and application of the advanced surgical implant products in the field of medical appliances are satisfied.
The invention aims at realizing the following technical scheme:
a method of forming an antimicrobial titanium alloy surgical implant comprising the steps of:
(1) Under the protection of nitrogen or inert gas, preparing an antibacterial titanium alloy artificial prosthesis blank sample from a medical titanium alloy wire through 3D printing, wherein the distance between an arc welding gun electrode and the surface of a processed workpiece is 1-3 mm;
the medical titanium alloy contains at least one of copper, zinc and silver;
(2) And (3) carrying out fine processing, cleaning and drying on the antibacterial titanium alloy artificial prosthesis blank sample through at least one process of milling, turning, drilling and compression molding to obtain the antibacterial titanium alloy surgical implant.
Preferably, the diameter of the medical titanium alloy wire in the step (1) is 1.0-3.0 mm, and the surface finish Ra is less than or equal to 3.2 microns.
Preferably, the mass content of the antibacterial metal element (at least one of copper, zinc and silver) in the medical titanium alloy in the step (1) is 0.5-6%.
Preferably, the medical titanium alloy in the step (1) is at least one of Ti6Al4V3Cu and Ti6Al4V5 Cu.
Preferably, the medical titanium alloy wire in the step (1) can be prepared from a bright bar (an extrusion bar or a rolling bar, etc.) with the diameter of 8.0-10.0 mm through conventional cold and hot working procedures such as rotary forging, rolling, drawing, etc., and the surface finish is obtained through conventional technological treatments such as grinding, polishing, etc.
Preferably, before the 3D printing in the step (1), the graphic digital file of the product to be processed is led into a wire printer and edited to generate a corresponding 3D printing program.
Preferably, the power supply system for 3D printing in the step (1) is an argon arc ac or dc welding power supply, wherein the arc working current corresponding to the argon arc ac or dc welding power supply is less than or equal to 400A, and the arc working voltage is less than or equal to 50V.
More preferably, the arc working current corresponding to the argon arc alternating current or direct current welding power supply is 200-300A, and the arc working voltage is 30-50V.
Preferably, the preparing the antibacterial titanium alloy artificial prosthesis blank sample by 3D printing in the step (1) means that the antibacterial titanium alloy artificial prosthesis blank sample is stacked layer by layer on a metal substrate by 3D printing, the metal substrate is made of titanium alloy, and after printing, the antibacterial titanium alloy artificial prosthesis blank sample is separated from the metal substrate, and then subsequent fine processing is performed.
More preferably, the metal substrate is a Ti6Al4V alloy plate.
Preferably, the fine processing in the step (2) refers to processing the antibacterial titanium alloy artificial prosthesis blank sample printed in 3D to a design specified size, and for some plate-type bone plates with obvious bending radian and the like, a special die can be adopted to locally press and mold the plate-type bone plates.
Preferably, the cleaning in the step (2) means that the antibacterial titanium alloy artificial prosthesis blank obtained by fine processing is placed in an acidic cleaning solution for ultrasonic cleaning for 2-6 min so as to remove impurities such as oxides, metal scraps and the like remained on the periphery of the prosthesis and the surface after the fine processing.
More preferably, the acidic cleaning solution consists of a volume ratio of 1:3:6, mixing industrial hydrofluoric acid, industrial nitric acid and water.
Compared with the prior art, the invention has the following advantages:
compared with the traditional antibacterial metal raw material plates, bars and the like, the method has the advantages that raw material wires are easy to obtain, and the raw material wires can be prepared by adopting common small drawing equipment without large-scale pressure processing equipment, so that the manufacturing cost is lower; the preparation method of the antibacterial surgical implant adopts the characteristics of simplicity, convenience, rapidness, high efficiency, practicability, lower production cost and the like of an independently developed wire printer, and adopts a powder printing process, so that the processing process of raw materials and final products is relatively complex, long in period, high in technical difficulty and strict in quality control requirement.
Detailed Description
The present invention will be described in further detail with reference to examples, but embodiments of the present invention are not limited thereto.
The specific conditions are not noted in the examples of the present invention, and are carried out according to conventional conditions or conditions suggested by the manufacturer. The raw materials, reagents, etc. used, which are not noted to the manufacturer, are conventional products commercially available.
The acidic cleaning solution in the examples and comparative examples of the present application consists of a volume ratio of 1:3:6, mixing industrial hydrofluoric acid, industrial nitric acid and water. The staphylococcus aureus deposit number ATCC6538.
Example 1
A Ti6Al4V3Cu alloy bright wire with the outer diameter of 2mm (with the finish degree of Ra3.2mu.m) is selected to manufacture the hip joint stem prosthesis, and a Ti6Al4V alloy plate with the thickness of 20mm is selected as a printing substrate. And (3) leading the graphic digital file of the product to be processed into a wire printer, editing and processing to generate a corresponding 3D printing program, welding by adopting an alternating current argon arc power supply, and stabilizing the current of an arc by about 240A and the working voltage of the arc by about 30V. The metal wires are printed layer by layer and piled up, the distance between the arc welding gun electrode and the surface of the processed workpiece is about 1mm, and the argon protection is adopted to reduce oxidation.
After the hip joint stem prosthesis blank manufactured by near net-shape three-dimensional printing is separated from the bottom plate, the hip joint stem prosthesis proximal cylindrical part, the distal part with radian and the redundant parts at the peripheral corners are finished to design specified dimensions according to actual product drawings by adopting numerical control milling, turning and other processes, finally, ultrasonic cleaning is carried out for 4min by adopting the specified pickling solution at room temperature, and finally, the antibacterial titanium alloy hip joint stem product related to the embodiment is obtained, wherein the compression strength is measured to be 1000+/-50 MPa, the elongation is about 16%, the microstructure is a dendrite and equiaxial crystal mixed structure, the oxygen content is 1200ppm, and the antibacterial rate to staphylococcus aureus is about 85.0%.
Example 2
Ti6Al4V5Cu alloy wires with the outer diameter of 1.6 mm (with the finish degree of Ra3.2 microns) are selected for producing the cervical interbody fusion cage prosthesis, and a Ti6Al4V alloy plate with the thickness of 20mm is selected as a printing substrate. And (3) leading the graphic digital file of the product to be processed into a wire printer, editing and processing to generate a corresponding 3D printing program, welding by adopting an alternating current argon arc power supply, and stabilizing the current by about 200A and the working voltage by about 30V. The metal wires are printed layer by layer and piled up, the distance between the arc welding gun electrode and the surface of the processed workpiece is about 1mm, and the argon protection is adopted to reduce oxidation.
After the cervical interbody fusion cage prosthesis blank manufactured by near-net-shape three-dimensional printing is separated from the bottom plate, the pyramid-shaped protruding part at the top of the peripheral side wall, the round hole and the oblong hole part of the peripheral side wall, the arc part and the redundant parts at the corners of the periphery of the hollow peripheral side wall of the cervical interbody fusion cage prosthesis are finished to the designed and regulated size according to the actual product drawing by adopting numerical control milling, turning and other processes, finally, ultrasonic cleaning is carried out for 3min at room temperature by adopting the regulated pickling solution, and finally, the antibacterial titanium alloy cervical interbody fusion cage product related to the embodiment is obtained, the compression strength is 1150+/-50 MPa, the elongation rate is about 14%, the microstructure is a dendritic crystal and equiaxed crystal mixed structure, the oxygen content is 1200ppm, and the antibacterial rate to staphylococcus aureus is about 98.0%.
Example 3
The collarbone hook bone plate is manufactured by Ti6Al4V3Cu alloy wires with the outer diameter of 2mm (with the finish degree of Ra3.2mu.m), and the Ti6Al4V alloy plate with the thickness of 20mm is selected as a printing substrate. And (3) leading the graphic digital file of the product to be processed into a wire printer, editing and processing to generate a corresponding 3D printing program, welding by adopting an alternating current argon arc power supply, and stabilizing the current by about 180A and the working voltage by about 30V. The metal wires are printed layer by layer and piled up, the distance between the arc welding gun electrode and the surface of the processed workpiece is about 1mm, and the argon protection is adopted to reduce oxidation.
Separating the collarbone hook bone plate blank manufactured by near net forming three-dimensional printing from the bottom plate, adopting numerical control milling, turning and other processes, carrying out finish machining on a prefabricated through hole, a bone plate radian part and an excessive part at a corner to a design specified size according to an actual product drawing, and carrying out plastic finishing on a bent part with a hook at one end by adopting a special die; finally, ultrasonic cleaning is carried out for 3min at room temperature by adopting the specified pickling solution, and the antibacterial titanium alloy collarbone hook bone fracture plate product with the thickness of 3mm and 9 holes, which is related to the embodiment, is finally obtained, the compressive strength of 980+/-30 MPa and the elongation of about 18% are measured, the microstructure is a mixed structure of dendrite and equiaxed crystal, the oxygen content is 1200ppm, and the antibacterial rate to staphylococcus aureus is about 87.0%.
Example 4
Ti6Al4V5Cu alloy wires with the outer diameter of 1.0 mm (with the finish degree of Ra3.2 microns) are selected to produce a personalized and customized mandibular facial bone defect patch prosthesis, and a Ti6Al4V alloy plate with the thickness of 20mm is selected as a printing substrate. And (3) leading the graphic digital file of the product to be processed into a wire printer, editing and processing to generate a corresponding 3D printing program, welding by adopting an alternating current argon arc power supply, and stabilizing the current by an arc to about 100A and the working voltage by the arc to about 30V. The metal wires are printed layer by layer and piled up, the distance between the arc welding gun electrode and the surface of the processed workpiece is about 1mm, and the argon protection is adopted to reduce oxidation.
Separating the mandibular defect patch prosthesis blank manufactured by near net-shape three-dimensional printing from a bottom plate, adopting numerical control milling and other processes, finishing the mandibular defect patch prosthesis with radian parts and redundant peripheral corners to designed and specified dimensions according to actual product drawings, finally carrying out ultrasonic cleaning for 3min at room temperature by adopting the specified pickling solution, and finally obtaining the antibacterial titanium alloy mandibular defect patch product according to the embodiment, wherein the compressive strength 1180+/-30 MPa is measured, the elongation is about 13%, the microstructure is a mixed structure of dendrite and equiaxed crystal, the oxygen content is 1200ppm, and the antibacterial rate to staphylococcus aureus is about 95.0%.
Comparative example 1
Ti6Al4V3Cu alloy powder (with the granularity of 80-120 mu m and the oxygen content of 1000 ppm) is selected to manufacture the hip joint stem prosthesis, and the printing substrate is a Ti6Al4V alloy plate with the thickness of 20 mm. And (3) importing the graphic digital file of the product to be processed into a laser printer, editing and processing to generate a corresponding 3D printing program, adopting a laser power supply, and paving a layer with the thickness of 0.2 mm/layer, wherein the current is 300 A+/-2A, the scanning speed is 800mm/s, and the scanning interval is 0.1 mm. The metal powder is printed layer by layer and stacked, and argon protection is adopted to reduce oxidation.
After the hip joint stem prosthesis blank manufactured by near net-shape three-dimensional printing is separated from the bottom plate, the hip joint stem prosthesis proximal cylindrical part, the distal part with radian and the redundant parts at the peripheral corners are finished to design specified dimensions according to actual product drawings by adopting numerical control milling, turning and other processes, finally, ultrasonic cleaning is carried out for 4min by adopting the specified pickling solution at room temperature, and finally, the antibacterial titanium alloy hip joint stem product related to the embodiment is obtained, wherein the compression strength is measured to be 1200+/-50 MPa, the elongation rate is about 8%, the microstructure is mainly coarse dendrite, the oxygen content is 1300ppm, and the antibacterial rate to staphylococcus aureus is 60.0%.
The above examples are preferred embodiments of the present invention, but the embodiments of the present invention are not limited to the above examples, and any other changes, modifications, substitutions, combinations, and simplifications that do not depart from the spirit and principle of the present invention should be made in the equivalent manner, and the embodiments are included in the protection scope of the present invention.
Claims (2)
1. A method of forming an antimicrobial titanium alloy surgical implant comprising the steps of:
(1) Under the protection of nitrogen or inert gas, preparing an antibacterial titanium alloy artificial prosthesis blank sample from a medical titanium alloy wire through 3D printing, wherein the distance between an arc welding gun electrode and the surface of a processed workpiece is 1-3 mm;
the medical titanium alloy contains at least one of copper, zinc and silver;
(2) The antibacterial titanium alloy artificial prosthesis blank is subjected to fine processing, cleaning and drying through at least one process of milling, turning, drilling and compression molding to obtain an antibacterial titanium alloy surgical implant;
the diameter of the medical titanium alloy wire in the step (1) is 1.0-3.0 mm, and the surface finish Ra is less than or equal to 3.2 microns;
the power supply system for 3D printing in the step (1) is an argon arc alternating current or direct current welding power supply, wherein the electric arc working current corresponding to the argon arc alternating current or direct current welding power supply is less than or equal to 400A, and the electric arc working voltage is less than or equal to 50V;
the electric arc working current corresponding to the argon arc alternating current or direct current welding power supply is 200-300A, and the electric arc working voltage is 30-50V;
the mass content of the antibacterial metal element in the medical titanium alloy in the step (1) is 0.5-6%;
the medical titanium alloy in the step (1) is at least one of Ti6Al4V3Cu and Ti6Al4V5 Cu;
preparing an antibacterial titanium alloy artificial prosthesis blank sample by 3D printing, namely stacking the antibacterial titanium alloy artificial prosthesis blank sample layer by layer on a metal substrate by 3D printing, wherein the metal substrate is made of titanium alloy, and after printing, the antibacterial titanium alloy artificial prosthesis blank sample is separated from the metal substrate and then subjected to subsequent fine processing; the metal substrate is a Ti6Al4V alloy plate;
before 3D printing, the graphic digital file of the product to be processed is led into a wire printer and edited to generate a corresponding 3D printing program;
the medical titanium alloy wire in the step (1) can be prepared from a bright bar with the diameter of 8.0-10.0 mm through rotary forging, rolling or cold-hot drawing processing procedures, and the surface finish is obtained through grinding and polishing processes; and (2) finely processing, namely processing the antibacterial titanium alloy artificial prosthesis blank which is printed in 3D to a design specified size.
2. The method for forming an antibacterial titanium alloy surgical implant according to claim 1, wherein the cleaning in the step (2) means that the antibacterial titanium alloy artificial prosthesis blank obtained by fine processing is placed in an acidic cleaning solution and subjected to ultrasonic cleaning for 2-6 min; the volume ratio of the acidic cleaning solution is 1:3:6, mixing industrial hydrofluoric acid, industrial nitric acid and water.
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