CN115090903A - Medical implant based on molecular sieve functional elements and preparation method thereof - Google Patents
Medical implant based on molecular sieve functional elements and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a medical implant based on molecular sieve functional elements and a preparation method and application thereof. Firstly, unit selection is carried out on a molecular sieve structure, a unit model is reconstructed to generate molecular sieve functional elements, the molecular sieve functional elements comprise but are not limited to pore parameter definitions such as pore diameter, rod diameter, porosity and unit size, the molecular sieve porous structure can be designed into a gradient porous structure with smoothly changed rod diameter, a porous implant prosthesis model is output after pore parameter optimization, and the porous implant prosthesis model is formed and prepared by an additive manufacturing method. The invention creatively uses the molecular sieve structure as the unit structure of the porous medical implant, optimizes the parameters of the molecular sieve structure such as porosity, pore diameter and the like, and ensures that the designed molecular sieve functional elements meet different biological behaviors of tissue cell adhesion, proliferation, differentiation and the like and also meet the technical process limitation of additive manufacturing. The medical implant based on the molecular sieve functional elements prepared by the invention has wide application prospect in artificial prostheses.
Description
Technical Field
The invention belongs to the field of biomedical functional materials and additive manufacturing, and particularly relates to a medical implant based on molecular sieve functional elements and a preparation method thereof.
Background
Due to the rapid growth and aging trend of the population, the demand of the modern society for bone implants is rapidly increasing, and higher requirements are clinically made on various performances of external implants that can be implanted into the human body. Among the commonly used materials in metal implants are stainless steel, cobalt-based alloys and titanium alloys. However, clinical research finds that the above alloy materials mainly have the following problems in the service process: the elastic modulus of the alloy material is too high, and for example, the elastic modulus of the Ti6Al4V alloy is about 110GPa and is far higher than the human bone modulus (0.022-21.8 GPa). The long-term implantation of the alloy material with excessively high elastic modulus in a human body can cause the function of the original bone tissue to be degraded and absorbed again, so that the stress shielding phenomenon is caused, and the implantation failure is caused. Therefore, there is a need to develop artificial implants having biocompatibility and mechanical properties closer to those of natural bones of the human body.
Structurally, the special structure of the porous structure greatly reduces the elastic modulus of the porous structure compared with a dense material, and effectively reduces the stress shielding effect. For this reason, porous structures are increasingly replacing dense materials as ideal candidates for implants. The porous structure can effectively improve the stress transfer between the implant and human bones, so that the implant and the bone tissues can be better biologically combined, and meanwhile, the porous structure has larger surface area, so that cells can be supplemented and permeated from the surrounding bone tissues to the inside of the structure of the porous structure, the regeneration and vascularization of bones are promoted, the cell proliferation and adhesion are facilitated, and the porous structure has great potential in biomedical implants. However, the porous structure adopted by the biomedical implant at present has many problems, such as the strength is greatly reduced while the elastic modulus is reduced, and the two cannot be achieved at the same time; the porous configuration is prone to stress concentration in the loaded environment, reducing the useful life of the implant. Therefore, a new porous structure configuration is required to be searched, the elastic modulus is reduced, the mechanical matching properties such as strength and the like are improved, and a certain cell behavior guiding requirement is met.
The molecular sieve is a micro-nano material with a regular and uniform pore structure, is widely applied to the fields of drug carriers and antibacterial agents, and is also widely applied to the preparation of molecular sieve coatings combined with alloy implants. The molecular sieve has a special pore channel structure, a huge specific surface area and multi-scale pore size, so that the molecular sieve has strong adsorption capacity, can reversibly adsorb/release functional ions or drug molecules, and can promote the implant to obtain better osseointegration capacity and antibacterial performance and prolong the service life of the implant by doping bioactive elements or antibacterial elements into the micro/nano composite structure coating. However, the molecular sieve structure itself belongs to a micro-level structure and cannot be directly applied to implant prostheses, so that the molecular sieve structure needs to be further redesigned by parameterization so as to meet various different requirements.
In recent years, the concept of a gradient porous structure has gradually entered the field of view of researchers of porous medical implants. Compared with a porous structure with uniform porosity, the gradient porous structure is more favorable for improving the success rate of implantation of the medical implant due to the changed porosity. The current prevailing view is that: the pore size of 100 mu m is favorable for cell adhesion; the aperture is 200 mu m, which is suitable for growing the fiber; the aperture of 300-; the aperture of the porous material is more than 400 mu m, which is beneficial to the growth of blood vessels. Wherein a single size pore size of less than 500 μm can impede the flow of cells and tissue, forming a plug. Meanwhile, the large pore size is beneficial to osteogenic growth due to the absorption and ion exchange of osteoinductive factors, but the large pore size also causes excessive fiber growth. Therefore, various single-size pore diameters have certain biological defects, and the design and preparation of a gradient porous structure become a research hotspot in the field of medical implantation.
As a new alloy preparation method, the additive manufacturing technology has great application potential in the field of preparing porous materials, breaks through the limitation of the traditional processing method, can effectively regulate and control the shape, size, distribution condition and the like of a pore structure, and is one of the most favorable processes for forming the porous structure.
At present, additive manufacturing technology is mostly used for printing traditional porous structures, such as cubic pores, rhombic dodecahedron and the like, and the elastic modulus of the printed and formed porous structures is as low as 3.4GPa, and the compressive strength is 200MPa (Addit Manual, 34(2020) 101264.). Compared with a compact titanium alloy material, the elastic modulus of the porous titanium alloy material is obviously reduced, but the porous structure has high structural rigidity and single pore diameter, and cannot simultaneously meet different biological cell behaviors, so that the design of the porous implant needs to consider not only the requirement on mechanical property, but also the contact guiding behavior of biological tissue cells and the limitation of an additive manufacturing process.
Disclosure of Invention
In order to overcome the defects and shortcomings of the prior art, the invention mainly aims to provide a preparation method of a medical implant based on molecular sieve functional elements.
Another object of the present invention is to provide a medical implant based on molecular sieve functional elements prepared by the above method.
The purpose of the invention is realized by the following technical scheme:
a preparation method of a medical implant based on molecular sieve functional primitives comprises the following steps:
(1) constructing functional elements of the molecular sieve: selecting a molecular sieve unit which represents the integral porous structure characteristic of the molecular sieve and has a central symmetry characteristic, drawing a molecular sieve unit pore parameter design domain according to biological cell function requirements and additive manufacturing process limitation constraints, determining each pore parameter of the molecular sieve unit according to the parameter design domain, and performing physical model reconstruction on the molecular sieve unit by adopting modeling software to construct a molecular sieve functional element;
(2) designing a molecular sieve gradient porous structure: designing the molecular sieve functional element structure in the step (1) into a gradient porous structure corresponding to smooth transition change of rod diameter, and constructing the molecular sieve functional element with the gradient porous structure;
(3) integrating and outputting the molecular sieve functional elements and the implant prosthesis model: generating an implant prosthesis model in software, inputting the molecular sieve functional elements in the step (1) or the molecular sieve functional elements in the gradient porous structure in the step (2) into the software as a basic unit model for filling corresponding parts of the implant prosthesis model to generate a porous implant prosthesis model;
(4) additive manufacturing forming preparation: and (3) repairing the part model of the molecular sieve functional element in the step (1) or the molecular sieve functional element with the gradient porous structure in the step (2) or the porous implant prosthesis model in the step (3) by using software, slicing, introducing into additive manufacturing equipment for customized subarea printing and forming, and performing post-treatment to obtain the solid part or prosthesis of the medical implant.
The medical implant based on the molecular sieve functional elements can be prepared by the method, the molecular sieve porous part has low elastic modulus, and has high strength and high energy absorption rate, the implantation success rate and the implantation service life of the medical implant are greatly improved, meanwhile, the porous pore parameters of the molecular sieve can be flexibly regulated and controlled to match different biological tissue cell behaviors and meet the limitation of additive manufacturing technology, the preparation performance and the formability of the high-performance molecular sieve porous part are ensured, and the design of the molecular sieve structure provides a new thought and direction for the preparation of the high-quality porous part.
Further, the process for reconstructing the physical model of the molecular sieve functional unit in the step (1) comprises the following steps: simplifying each support rod in the molecular sieve unit into a line, drawing a wire frame diagram of the molecular sieve unit in software, then rotating for a circle by using each wire frame as a central shaft and a designated radius (half of the rod diameter) and materializing to obtain the functional elements of the molecular sieve.
Further, the modeling software in the step (1) is CAD modeling software SolidWorks.
Further, the pore parameters in step (1) include porosity, pore diameter, rod diameter, unit size and other parameters.
Further, the biological cell functional requirements in step (1) are specifically: the value range of the pore parameters comprises that the unit size (molecular sieve unit) is 3-4 mm, and the porosity is 60% -90%; the aperture range is 200-1200 mu m; the additive manufacturing process limitations are specifically: the diameter of the rod ranges from 200 mu m to 1000 mu m.
Further, the molecular sieve functional unit in the step (1) is specifically: the rod diameter and the aperture of the molecular sieve functional element can be flexibly regulated and controlled, and the aperture within the range of 200-1200 mu m and the rod diameter change within the range of 200-1000 mu m can be realized, so that the functional requirements of biological cells and the limitation of an additive manufacturing process can be simultaneously met.
Further, the pore parameter design domain in the step (1) is specifically: and drawing a pore parameter design domain of the molecular sieve functional elements by taking the pore diameter of 200-1200 mu m, the porosity of 60-90% and the rod diameter of 200-1000 mu m as constraint conditions.
Further, the gradient porous structure corresponding to the smooth transition change of the rod diameter in the step (2) refers to a gradient porous structure corresponding to the smooth transition change of the rod diameter within the range of 200-1000 μm.
Further, the gradient porous structure design of the molecular sieve in the step (2) adopts a Grasshopper platform of gradient porous design software.
Further, the filling of the corresponding part in the step (3) means that the porous implant prosthesis is divided into a dense region and a porous region, and the porous region is filled with the molecular sieve functional unit.
Further, in the step (3), the software is Rhino.
Further, the software for model repair and slice processing in the step (4) is materials Magics and RP-Tools, respectively.
Further, the medical alloy used for the additive manufacturing in the step (4) is at least one of medical pure titanium, medical TC4, Ti-Nb series, Ti-Mo series, Ti-Zr series, Ti-Nb-Hf series, Ti-Nb-Zr series medical beta-type titanium alloy, NiTi series shape memory alloy, CoCr series alloy and medical stainless steel.
Furthermore, the medical alloy used in the additive manufacturing in the step (4) is medical titanium alloy spherical powder, the preparation method is a plasma atomization method, an electrode induction melting gas atomization method or a plasma rotating electrode atomization powder preparation method, the particle size range of the powder is 15-65 mu m, and the oxygen content of the powder is lower than 300 ppm. Drying at 60-80 ℃ before printing and forming, wherein the preheating temperature of the substrate is 200 ℃.
Further, the customized partition printing in step (4) is shaped as: performing zonal printing to form a compact area and a porous area of the medical implant by adjusting process parameters, wherein the laser power range of the compact area is 200-240W, the laser scanning speed range is 1000-1200 mm/s, the laser scanning interval range is 60-80 mm, and the layer thickness range is 30-50 mm; the laser power range of the porous region is 160-200W, the laser scanning speed range is 1200-2000 mm/s, the laser scanning interval range is 60-80 mm, and the layer thickness range is 30-45 mm.
Further, the additive manufacturing apparatus in the step (4) is one of CONCEPT LASER M2, EOS M280/290, SLMsolution 125/250/2802.0/500, RENISHAW 400, BLT-S320, Archam A2x, Archam Q20, QEBAM Lab200, and Qbeam 3D.
Further, the post-treatment process in the step (4) comprises the following steps: the method comprises the steps of ultrasonically cleaning for 0.5-1 hour by using a mixed solution of acetone, 2-propanol, hydrofluoric acid and ultrapure water (the volume ratio is 1:1:1:7), drying for 10-12 hours in an oven at 40-60 ℃, heating for 1-2 hours in an inert atmosphere furnace at 1300 ℃, cooling along with the furnace, and performing sand blasting by using a sand blasting machine of the model LV 6050A.
A medical implant based on molecular sieve functional elements is prepared by the method.
The obtained medical implant (porous part) is low in elastic modulus (0.5-5 GPa), high in yield strength (50-200 MPa) and high in energy absorption efficiency (more than 70%). The implants include joint implants (hip, knee implants), spinal implants (internal fixation implants, minimally invasive implants, etc.), shoulder implants (scapular implants, etc.), craniomaxillofacial implants (mandibular implants, cranial implants, etc.), ankle implants (ankle implants, toe implants, etc.), and other site implants (sternum implants, etc.).
The principle of the preparation method of the invention is as follows: firstly, unit selection is carried out on a molecular sieve structure, a unit model is reconstructed to generate a molecular sieve functional element, the molecular sieve functional element comprises but is not limited to definition of pore parameters such as pore diameter, rod diameter, porosity and unit size, furthermore, the molecular sieve functional element structure is designed into a gradient porous structure with smoothly changing rod diameter, the molecular sieve functional element or the molecular sieve gradient porous structure is integrated with an implant prosthesis model, then the porous implant prosthesis model is output, and the porous implant prosthesis model is formed and prepared by an additive manufacturing method. According to the physical properties of different medical alloy powder, the process parameters are adjusted to perform customized partitioned additive manufacturing, printing and forming, so that the mechanical properties and the forming quality of the compact part and the porous part of the porous implant are adjusted and controlled, and the requirements of the biological and mechanical properties of the medical implant are met.
Compared with the prior art, the invention has the following advantages and beneficial effects:
1. compared with the traditional porous structure, the porous functional element based on the molecular sieve structure provided by the invention has low elastic modulus, high strength and high energy absorption rate, and greatly improves the implantation success rate and the implantation service life of the medical implant.
2. The molecular sieve functional element pore parameters designed by the invention can be flexibly regulated and controlled to match different biological tissue cell behaviors and meet the technical process limitation of additive manufacturing, and the preparation and formability of the high-performance molecular sieve porous part are ensured.
3. The invention is prepared by adopting an additive manufacturing process, can prepare parts with various complex shapes compared with the traditional casting forming and plastic forming process, meets the requirement of personalized design, and has high material utilization rate and low processing cost.
Drawings
FIG. 1 is a design domain of pore parameters of a functional motif of a molecular sieve. Wherein the constraint conditions are as follows: the pore diameter ranges from 200 mu m to 1200 mu m, the rod diameter ranges from more than 200 mu m, the porosity ranges from 60 percent to 90 percent, and the shaded area represents the design domain of the functional elementary pore parameters of the molecular sieve. Wherein (a) is the large aperture constraint of the molecular sieve functional unit, and (b) is the small aperture constraint of the molecular sieve functional unit.
FIG. 2 shows a pure Ti linear gradient porous part based on molecular sieve functional units in example 1, wherein the rod diameter ranges from 364 μm to 748 μm, the yield strength is measured to be 62.5MPa, the elastic modulus is measured to be 2.47GPa, and the energy absorption We is measured to be 0.5 and is 58MJ/m 3 The energy absorption efficiency was 88%.
FIG. 3 shows a NiTi axial gradient porous part based on molecular sieve functional units in example 2, wherein the rod diameter ranges from 364 μm to 748 μm, the yield strength is measured to be 62.7MPa, the elastic modulus is measured to be 2.45GPa, and the energy absorption We is measured to be 0.5 and is measured to be 61.7MJ/m 3 The energy absorption efficiency was 91%.
FIG. 4 is a cylindrical gradient porous part of TiNbZrTa based on functional units of molecular sieve in example 3, with a rod diameter ranging from 394 μm to 712 μm, a yield strength of 74.4MPa, an elastic modulus of 2.53GPa, and an energy absorption We of 62.1MJ/m, wherein 0.5 is used as energy absorption We 3 The energy absorption efficiency was 90%.
FIG. 5 shows TiNbZrTa sphere center gradient porous parts based on molecular sieve functional units in example 4, wherein the rod diameter ranges from 410 μm to 712 μm, the yield strength is 73.9MPa, the elastic modulus is 2.50GPa, and the energy absorption We is 60.4MJ/m 3 The energy absorption efficiency was 87%.
FIG. 6 shows a pure Ti acetabular cup prosthesis based on molecular sieve functional motifs according to example 5 of the present invention. Wherein, (a) is a molecular sieve functional element with the optimized porosity of 70 percent; (b) shaped porous parts based on molecular sieve functional elements were prepared for additive manufacturing and were measured to have a yield strength of 77.5MPa, a modulus of elasticity of 2.77GPa, and an energy absorption We ═ 0.5 of 65.5MJ/m 3 The absorption efficiency is 80%; (c) shaped molecular sieve functional primitive-based acetabular cup prostheses are prepared for additive manufacturing.
FIG. 7 is a TiNbZrTa femoral stem prosthesis based on molecular sieve functional units in example 8 of the present invention. Wherein, (a) is a molecular sieve functional element with optimized porosity of 60 percent; (b) shaped porous parts based on molecular sieve functional elements are prepared for additive manufacturing, and the yield strength is measured to be 102.9MPa,the elastic modulus is 3.56GPa, the energy absorption We is 90.1MJ/m when 0.5 3 The energy absorption efficiency is 85%; (c) a shaped femoral stem prosthesis based on molecular sieve functional motifs was prepared for additive manufacturing.
Detailed Description
The present invention will be described in further detail with reference to examples and drawings, but the embodiments of the present invention are not limited thereto.
Those who do not specify specific conditions in the examples of the present invention follow conventional conditions or conditions recommended by the manufacturer. The raw materials, reagents and the like which are not indicated by manufacturers are all conventional products which can be obtained commercially.
Example 1: (pure Ti linear gradient porous parts based on molecular sieve functional units, as shown in FIG. 2)
(1) Constructing functional elements of the molecular sieve: selecting a molecular sieve unit which represents the integral porous structure characteristic of the molecular sieve and has a centrosymmetric characteristic, drawing a molecular sieve unit pore parameter design domain according to the functional requirements of biological cells (the unit size is 3-4 mm, the porosity is 60% -90%, the pore diameter range is 200-1200 mu m) and the constraint of additive manufacturing process (the rod diameter range is 200-1000 mu m), and determining each pore parameter of the molecular sieve unit according to the parameter design domain, wherein the unit size is 3.5mm, the porosity is 70%, the large pore diameter is 784 mu m, the small pore diameter is 572 mu m, and the rod diameter is 552 mu m; adopting CAD modeling software SolidWorks to carry out physical model reconstruction on the molecular sieve unit according to each confirmed pore parameter, and constructing a molecular sieve functional element;
(2) designing a molecular sieve gradient porous structure: designing a molecular sieve functional element into a corresponding linear gradient porous structure with smoothly changed rod diameter by adopting a Grasshopper platform of gradient porous design software, wherein the porosity is 70%, the rod diameter change range is 364-748 mu m, and the rod diameter change direction is gradually thickened from bottom to top, so as to construct the molecular sieve functional element with the gradient porous structure;
(3) additive manufacturing forming preparation: introducing STL format of molecular sieve functional elements with gradient porous structures into Materialise Magics for model repair, label creation and support, using RP-Tools software to perform slicing processing, and introducing the STL model into a laser selective melting EOS M280 device for printing and forming, wherein the parameters are that laser power is 160W, scanning speed is 1200mm/s, laser scanning distance is 60mm, and layer thickness is 30 mm. The powder material is medical pure Ti powder with the particle size of 15-53 mu m, and is dried at 60 ℃ before printing, and the substrate preheating temperature is 200 ℃. Cutting off the substrate by linear cutting after printing, cleaning the substrate for 1 hour by using a mixed solution of acetone, 2-propanol, hydrofluoric acid and ultrapure water (the volume ratio is 1:1:1:7) in an ultrasonic cleaning machine, drying the substrate for 10 hours in a 40 ℃ oven, heating the substrate in a 1300 ℃ inert atmosphere furnace for 1 hour, cooling the substrate along with the furnace, and performing sand blasting treatment on the substrate at 0.6MPa by using 220-mesh alumina corundum to obtain the gradient porous part.
Example 2: (NiTi axial gradient porous parts based on molecular sieve functional elements, as shown in FIG. 3)
(1) Constructing functional elements of the molecular sieve: selecting a unit model which represents the integral porous structure characteristic of the molecular sieve and has a centrosymmetric characteristic, drawing a molecular sieve unit pore parameter design domain according to the functional requirements of biological cells (the unit size is 3-4 mm, the porosity is 60% -90%, the pore diameter range is 200-1200 mu m) and the constraint of an additive manufacturing process (the rod diameter range is 200-1000 mu m), and determining each pore parameter of the molecular sieve unit according to the parameter design domain, wherein the unit size is 3.5mm, the porosity is 70%, the large pore diameter is 784 mu m, the small pore diameter is 572 mu m, and the rod diameter is 552 mu m; adopting CAD modeling software SolidWorks to carry out physical model reconstruction on the molecular sieve unit according to each confirmed pore parameter, and constructing a molecular sieve functional element;
(2) designing a molecular sieve gradient porous structure: designing a molecular sieve functional element into a corresponding linear gradient porous structure with rod diameter smoothly transitionally changed by adopting a Grasshopper platform of gradient porous design software, wherein the porosity is 70 percent, the rod diameter change range is 364-748 mu m, the rod diameter change direction is a central line in the height direction as a reference axis, and the rod diameters gradually thicken upwards and downwards respectively to construct the molecular sieve functional element with the gradient porous structure;
(3) additive manufacturing forming preparation: introducing STL format of molecular sieve functional elements with gradient porous structures into Materialise Magics for model repair, label creation and support, using RP-Tools software to perform slicing processing, and introducing the STL model into a laser selective melting EOS M280 device for printing and forming, wherein the parameters are that laser power is 200W, scanning speed is 2000mm/s, laser scanning distance is 80mm, and layer thickness is 30 mm. The powder material is NiTi alloy powder, the particle size of the powder is 15-53 mu m, the powder is dried at 60 ℃ before printing, and the preheating temperature of the substrate is 200 ℃. Cutting off the substrate by linear cutting after printing, cleaning the substrate for 1 hour by using a mixed solution of acetone, 2-propanol, hydrofluoric acid and ultrapure water (the volume ratio is 1:1:1:7) in an ultrasonic cleaning machine, drying the substrate for 10 hours in a 40 ℃ oven, heating the substrate for 1 hour in a 1300 ℃ inert atmosphere furnace, cooling the substrate along with the furnace, and performing sand blasting treatment on 220-mesh alumina corundum at 0.6MPa to obtain the gradient porous part.
Example 3: (TiNbZrTa cylindrical gradient porous parts based on molecular sieve functional elements, as shown in FIG. 4)
(1) Construction of molecular sieve functional elements: selecting a unit model which represents the integral porous structure characteristic of the molecular sieve and has a centrosymmetric characteristic, drawing a molecular sieve unit pore parameter design domain according to the functional requirements of biological cells (the unit size is 3-4 mm, the porosity is 60% -90%, the pore diameter range is 200-1200 mu m) and the constraint of an additive manufacturing process (the rod diameter range is 200-1000 mu m), and determining each pore parameter of the molecular sieve unit according to the parameter design domain, wherein the unit size is 3.5mm, the porosity is 70%, the large pore diameter is 784 mu m, the small pore diameter is 572 mu m, and the rod diameter is 552 mu m; adopting CAD modeling software SolidWorks to carry out physical model reconstruction on the molecular sieve unit according to each confirmed pore parameter, and constructing a molecular sieve functional element;
(2) designing a molecular sieve gradient porous structure: designing a molecular sieve functional element into a corresponding linear gradient porous structure with rod diameter smoothly transitionally changed by adopting a Grasshopper platform of gradient porous design software, wherein the porosity is 70 percent, the rod diameter change range is 394-712 mu m, the rod diameter change direction is that the central point is taken as the center of a circle, and the rod diameter gradually becomes thicker along the radius direction of a cylinder, so as to construct the molecular sieve functional element with the gradient porous structure;
(3) additive manufacturing forming preparation: introducing STL format of molecular sieve functional elements with gradient porous structures into Materialise Magics for model repair, label creation and support, using RP-Tools software to perform slicing processing, and introducing the STL format into a laser selective melting EOS M280 device for printing and forming, wherein the parameters are that laser power is 160W, scanning speed is 1600mm/s, laser scanning distance is 60mm, and layer thickness is 30 mm. The powder material is TiNbZrTa alloy powder, the particle size of the powder is 15-53 mu m, drying is carried out at 60 ℃ before printing, and the substrate preheating temperature is 200 ℃. Cutting off the substrate by linear cutting after printing, cleaning the substrate for 1 hour by using a mixed solution of acetone, 2-propanol, hydrofluoric acid and ultrapure water (the volume ratio is 1:1:1:7) in an ultrasonic cleaning machine, drying the substrate for 10 hours in a 40 ℃ oven, heating the substrate for 1 hour in a 1300 ℃ inert atmosphere furnace, cooling the substrate along with the furnace, and performing sand blasting treatment on 220-mesh alumina corundum at 0.6MPa to obtain the gradient porous part.
Example 4: (TiNbZrTa spherical center gradient porous parts based on molecular sieve functional elements, as shown in FIG. 5)
(1) Constructing functional elements of the molecular sieve: selecting a unit model which represents the integral porous structure characteristic of the molecular sieve and has a centrosymmetric characteristic, drawing a molecular sieve unit pore parameter design domain according to the functional requirements of biological cells (the unit size is 3-4 mm, the porosity is 60% -90%, the pore diameter range is 200-1200 mu m) and the constraint of an additive manufacturing process (the rod diameter range is 200-1000 mu m), and determining each pore parameter of the molecular sieve unit according to the parameter design domain, wherein the unit size is 3.5mm, the porosity is 70%, the large pore diameter is 784 mu m, the small pore diameter is 572 mu m, and the rod diameter range is 552 mu m; adopting CAD modeling software SolidWorks to carry out physical model reconstruction on the molecular sieve unit according to each confirmed pore parameter, and constructing a molecular sieve functional element;
(2) designing a molecular sieve gradient porous structure: designing a corresponding linear gradient porous structure with smoothly transitionally changed rod diameters by adopting Grasshopper platform molecular sieve functional elements of gradient porous design software, wherein the porosity is 70 percent, the rod diameter change range is 410-712 mu m, the rod diameter change direction is that the central point is taken as the center of a circle, and the rod diameters are gradually thickened along the direction of the radius of the sphere to construct the molecular sieve functional elements of the gradient porous structure;
(3) additive manufacturing forming preparation: introducing STL format of molecular sieve functional elements with gradient porous structures into Materialise Magics for model repair, label creation and support, using RP-Tools software to perform slicing processing, and introducing the STL format into a laser selective melting EOS M280 device for printing and forming, wherein the parameters are that laser power is 160W, scanning speed is 1600mm/s, laser scanning distance is 60mm, and layer thickness is 30 mm. The powder material is TiNbZrTa alloy powder, the particle size of the powder is 15-53 mu m, drying is carried out at 60 ℃ before printing, and the preheating temperature of the substrate is 200 ℃. Cutting off the substrate by linear cutting after printing, cleaning the substrate for 1 hour by using a mixed solution of acetone, 2-propanol, hydrofluoric acid and ultrapure water (the volume ratio is 1:1:1:7) in an ultrasonic cleaning machine, drying the substrate for 10 hours in a 40 ℃ oven, heating the substrate for 1 hour in a 1300 ℃ inert atmosphere furnace, cooling the substrate along with the furnace, and performing sand blasting treatment on 220-mesh alumina corundum at 0.6MPa to obtain the gradient porous part.
Example 5: (pure Ti porous acetabular cup prosthesis based on molecular sieve functional elements, as shown in FIG. 6)
(1) Construction of molecular sieve functional elements: selecting a unit model which represents the overall porous structure characteristics of the molecular sieve and has a central symmetry characteristic, drawing a molecular sieve unit pore parameter design domain (namely drawing a pore diameter-rod diameter-porosity relation graph) according to biological cell function requirements (the unit size is 3-4 mm, the porosity is 60% -90%, the pore diameter range is 200-1200 mu m) and additive manufacturing process constraints (the rod diameter range is 200-1000 mu m), and determining each pore parameter of the molecular sieve unit according to the parameter design domain, wherein the unit size is 3.0mm, the porosity is 60%, the large pore diameter is 588 mu m, the small pore diameter is 406 mu m, and the rod diameter is 560 mu m; adopting CAD modeling software SolidWorks to carry out physical model reconstruction on the molecular sieve unit according to the confirmed pore parameters to construct a molecular sieve functional element;
(2) integrating the molecular sieve functional elements with the implant prosthesis model and outputting: generating an acetabular cup prosthesis model in the Rhino software, inputting molecular sieve functional primitives into the Rhino software to serve as a basic unit model, filling porous regions of the acetabular cup prosthesis model with the molecular sieve functional primitives, and finally generating a corresponding molecular sieve porous acetabular cup prosthesis model;
(3) additive manufacturing forming preparation: after a porous prosthesis model STL format is led into Materialise Magics for model repair, label creation and support, RP-Tools software is used for slicing processing, the STL model is led into laser selective melting EOS M280 equipment for printing and forming, the used parameters are that the laser power of a compact area is 200W, the scanning speed is 1000mm/s, the laser scanning interval is 60mm, the layer thickness is 30mm, the laser power of a porous area is 160W, the laser scanning speed is 1200mm/s, the laser scanning interval is 60mm and the layer thickness is 30 mm. The powder material is medical pure Ti powder with the particle size of 15-53 mu m, and is dried at 60 ℃ before printing, and the substrate preheating temperature is 200 ℃. Cutting off the substrate by linear cutting after printing, cleaning the substrate for 1 hour by using a mixed solution of acetone, 2-propanol, hydrofluoric acid and ultrapure water (the volume ratio is 1:1:1:7) in an ultrasonic cleaning machine, drying the substrate for 10 hours in a drying oven at 40 ℃, heating the substrate for 1 hour in an inert atmosphere furnace at 1300 ℃, cooling the substrate along with the furnace, and performing sand blasting treatment on 220-mesh alumina corundum at 0.6MPa to obtain the final prosthesis.
Example 6: (NiTi porous acetabular cup prosthesis based on molecular sieve functional elements)
(1) Construction of molecular sieve functional elements: selecting a unit model which represents the integral porous structure characteristics of the molecular sieve and has a central symmetry characteristic, drawing a molecular sieve unit pore parameter design domain (namely drawing a pore diameter-rod diameter-porosity relation graph) according to biological cell function requirements (the unit size is 3-4 mm, the porosity is 60% -90%, the pore diameter range is 200-1200 mu m) and additive manufacturing process constraints (the rod diameter range is 200-1000 mu m), and determining each pore parameter of the molecular sieve unit according to the parameter design domain, wherein the unit size is 3.5mm, the porosity is 70%, the large pore diameter is 784 mu m, the small pore diameter is 572 mu m, and the rod diameter is 552 mu m; adopting CAD modeling software SolidWorks to carry out physical model reconstruction on the molecular sieve unit according to each confirmed pore parameter, and constructing a molecular sieve functional element;
(2) integrating and outputting the molecular sieve functional elements and the implant prosthesis model: generating an acetabular cup prosthesis model in the Rhino software, inputting molecular sieve functional primitives into the Rhino software to serve as a basic unit model, filling porous regions of the acetabular cup prosthesis model with the molecular sieve functional primitives, and finally generating a corresponding molecular sieve porous acetabular cup prosthesis model;
(3) additive manufacturing forming preparation: after a porous prosthesis model STL format is led into Materialise Magics for model repair, label creation and support, RP-Tools software is used for slicing processing, the STL model is led into a laser selective melting EOS M280 device for printing and forming, the used parameters are that the laser power of a compact area is 200W, the scanning speed is 1000mm/s, the laser scanning interval is 80mm, the layer thickness is 30mm, the laser power of a porous area is 200W, the laser scanning speed is 2000mm/s, the laser scanning interval is 80mm, and the layer thickness is 30 mm. The powder material is NiTi alloy powder, the particle size of the powder is 15-53 mu m, drying is carried out at 60 ℃ before printing, and the preheating temperature of the substrate is 200 ℃. Cutting off the substrate by linear cutting after printing, cleaning the substrate for 1 hour by using a mixed solution of acetone, 2-propanol, hydrofluoric acid and ultrapure water (the volume ratio is 1:1:1:7) in an ultrasonic cleaning machine, drying the substrate for 10 hours in a drying oven at 40 ℃, heating the substrate for 1 hour in an inert atmosphere furnace at 1300 ℃, cooling the substrate along with the furnace, and performing sand blasting treatment on 220-mesh alumina corundum at 0.6MPa to obtain the final prosthesis.
Example 7: (TiNbZrTa porous femoral stem prosthesis based on molecular sieve functional elements, as shown in figure 6)
(1) Constructing functional elements of the molecular sieve: selecting a unit model which represents the integral porous structure characteristics of the molecular sieve and has a central symmetry characteristic, drawing a molecular sieve unit pore parameter design domain (namely drawing a pore diameter-rod diameter-porosity relation graph) according to biological cell function requirements (the unit size is 3-4 mm, the porosity is 60% -90%, the pore diameter range is 200-1200 mu m) and additive manufacturing process constraints (the rod diameter range is 200-1000 mu m), and determining each pore parameter of the molecular sieve unit according to the parameter design domain, wherein the unit size is 3.5mm, the porosity is 80%, the large pore diameter is 899 mu m, the small pore diameter is 685 mu m, and the rod diameter is 436 mu m; adopting CAD modeling software SolidWorks to carry out physical model reconstruction on the molecular sieve unit according to each confirmed pore parameter, and constructing a molecular sieve functional element;
(2) integrating and outputting the molecular sieve functional elements and the implant prosthesis model: generating an acetabular cup prosthesis model molecular sieve functional element in a Rhino software, inputting the molecular sieve functional element into the Rhino software to serve as a basic unit model, filling a porous region of the acetabular cup prosthesis model with the molecular sieve functional element, and finally generating a corresponding molecular sieve porous femoral stem prosthesis model;
(3) additive manufacturing forming preparation: after a porous prosthesis model STL format is led into Materialise Magics for model repair and label creation and support, an RP-Tools software is used for slicing processing, and then the STL model is led into a laser selective melting EOS 280 device for printing and forming, wherein the parameters are that the laser power of a compact area is 240W, the scanning speed is 1200mm/s, the laser scanning interval is 60mm, the layer thickness is 30mm, the laser power of a porous area is 160W, the laser scanning speed is 1600mm/s, the laser scanning interval is 60mm and the layer thickness is 30 mm. The powder material is TiNbZrTa alloy powder, the particle size of the powder is 15-53 mu m, drying is carried out at 60 ℃ before printing, and the substrate preheating temperature is 200 ℃. Cutting off the substrate by linear cutting after printing, cleaning the substrate for 1 hour by using a mixed solution of acetone, 2-propanol, hydrofluoric acid and ultrapure water (the volume ratio is 1:1:1:7) in an ultrasonic cleaning machine, drying the substrate for 10 hours in a drying oven at 40 ℃, heating the substrate for 1 hour in an inert atmosphere furnace at 1300 ℃, cooling the substrate along with the furnace, and performing sand blasting treatment on 220-mesh alumina corundum at 0.6MPa to obtain the final prosthesis.
Example 8: (TiNbZrTa porous femoral stem prosthesis based on molecular sieve functional elements)
(1) Constructing functional elements of the molecular sieve: selecting a unit model representing the integral porous structure characteristics of the molecular sieve and having a central symmetry characteristic, drawing a molecular sieve unit pore parameter design domain (namely drawing a pore diameter-rod diameter-porosity relation graph) according to biological cell function requirements (the unit size is 3-4 mm, the porosity is 60% -90%, the pore diameter range is 200-1200 mu m) and additive manufacturing process constraints (the rod diameter range is 200-1000 mu m), and determining each pore parameter of the molecular sieve unit according to the parameter design domain, wherein the unit size is 4.0mm, the porosity is 90%, the large pore diameter is 1195 mu m, the small pore diameter is 952 mu m, and the rod diameter is 332 mu m; adopting CAD modeling software SolidWorks to carry out physical model reconstruction on the molecular sieve unit according to the confirmed pore parameters to construct a molecular sieve functional element;
(2) integrating and outputting the molecular sieve functional elements and the implant prosthesis model: generating an acetabular cup prosthesis model in the Rhino software, inputting molecular sieve functional primitives into the Rhino software to serve as a basic unit model, filling porous regions of the acetabular cup prosthesis model with the molecular sieve functional primitives, and finally generating a corresponding molecular sieve porous femoral stem prosthesis model;
(3) additive manufacturing forming preparation: after a porous prosthesis model STL format is led into Materialise Magics for model repair and label creation and support, an RP-Tools software is used for slicing processing, and then the STL model is led into a laser selective melting EOS 280 device for printing and forming, wherein the parameters are that the laser power of a compact area is 240W, the scanning speed is 1200mm/s, the laser scanning interval is 60mm, the layer thickness is 30mm, the laser power of a porous area is 160W, the laser scanning speed is 1600mm/s, the laser scanning interval is 60mm and the layer thickness is 30 mm. The powder material is TiNbZrTa alloy powder, the particle size of the powder is 15-53 mu m, drying is carried out at 60 ℃ before printing, and the substrate preheating temperature is 200 ℃. Cutting off the substrate by linear cutting after printing, cleaning the substrate for 1 hour by using a mixed solution of acetone, 2-propanol, hydrofluoric acid and ultrapure water (the volume ratio is 1:1:1:7) in an ultrasonic cleaning machine, drying the substrate for 10 hours in a drying oven at 40 ℃, heating the substrate for 1 hour in an inert atmosphere furnace at 1300 ℃, cooling the substrate along with the furnace, and performing sand blasting treatment on 220-mesh alumina corundum at 0.6MPa to obtain the final prosthesis.
The above embodiments are preferred embodiments of the present invention, but the present invention is not limited to the above embodiments, and any other changes, modifications, substitutions, combinations, and simplifications which do not depart from the spirit and principle of the present invention should be construed as equivalents thereof, and all such changes, modifications, substitutions, combinations, and simplifications are intended to be included in the scope of the present invention.
Claims (10)
1. A preparation method of a medical implant based on molecular sieve functional elements is characterized by comprising the following steps:
(1) constructing functional elements of the molecular sieve: selecting a molecular sieve unit which represents the integral porous structure characteristic of the molecular sieve and has a central symmetry characteristic, drawing a molecular sieve unit pore parameter design domain according to biological cell function requirements and additive manufacturing process limitation constraints, determining each pore parameter of the molecular sieve unit according to the parameter design domain, and performing physical model reconstruction on the molecular sieve unit by adopting modeling software to construct a molecular sieve functional element;
(2) designing a molecular sieve gradient porous structure: designing the molecular sieve functional element structure in the step (1) into a gradient porous structure corresponding to smooth transition change of rod diameter, and constructing the molecular sieve functional element with the gradient porous structure;
(3) integrating and outputting the molecular sieve functional elements and the implant prosthesis model: generating an implant prosthesis model in software, inputting the molecular sieve functional elements in the step (1) or the molecular sieve functional elements with the gradient porous structure in the step (2) into the software as a basic unit model for filling corresponding parts of the implant prosthesis model to generate a porous implant prosthesis model;
(4) additive manufacturing and forming preparation: and (3) repairing the part model of the molecular sieve functional element in the step (1) or the molecular sieve functional element with the gradient porous structure in the step (2) or the porous implant prosthesis model in the step (3) by using software, slicing, introducing into additive manufacturing equipment for customized subarea printing and forming, and performing post-treatment to obtain the solid part or prosthesis of the medical implant.
2. The method for preparing a medical implant based on molecular sieve functional motifs according to claim 1, wherein the biological cell functional requirements in step (1) are in particular: the value range of the porosity parameter comprises that the unit size is 3 mm-4 mm, and the porosity is 60% -90%; the aperture range is 200-1200 mu m; the additive manufacturing process limitations are specifically: the diameter range of the rod is 200-1000 μm; the pore parameters comprise porosity, pore diameter, rod diameter and unit size;
the pore parameter design domain in the step (1) is specifically as follows: and drawing a pore parameter design domain of the molecular sieve functional elements by taking the pore diameter of 200-1200 mu m, the porosity of 60-90% and the rod diameter of 200-1000 mu m as constraint conditions.
3. The method for preparing a medical implant based on molecular sieve functional motifs according to claim 1, wherein the physical model reconstruction process of the molecular sieve functional motifs in the step (1) is as follows: simplifying each support rod in the molecular sieve unit into a line, drawing a line frame diagram of the molecular sieve unit in software, then rotating for a circle by using each line frame as a central axis and a specified radius, and materializing to obtain a molecular sieve functional element; the designated radius is half of the rod diameter.
4. The method for preparing a medical implant based on molecular sieve functional motifs according to claim 1, wherein the customized zoned printing in step (4) is shaped as: performing zonal printing to form a compact area and a porous area of the medical implant by adjusting process parameters, wherein the laser power range of the compact area is 200-240W, the laser scanning speed range is 1000-1200 mm/s, the laser scanning interval range is 60-80 mm, and the layer thickness range is 30-50 mm; the laser power range of the porous region is 160-200W, the laser scanning speed range is 1200-2000 mm/s, the laser scanning interval range is 60-80 mm, and the layer thickness range is 30-45 mm.
5. The method for preparing a medical implant based on molecular sieve functional elements according to claim 1, wherein the step (2) of obtaining a gradient porous structure corresponding to the smooth transition change of the rod diameter refers to a step porous structure corresponding to the smooth transition change of the rod diameter within a range of 200-1000 μm.
6. The method for preparing a medical implant based on molecular sieve functional motifs according to claim 1, wherein the modeling software in step (1) is CAD modeling software SolidWorks;
in the step (2), a Grasshopper platform is adopted for the design of the gradient porous structure of the molecular sieve; the software in the step (3) is Rhino;
and (4) respectively adopting materials Magics and RP-Tools as software for model repair and slice processing in the step (4).
7. The method for preparing a medical implant based on molecular sieve functional motifs according to claim 1, wherein the filling corresponding site in the step (3) means that the porous implant prosthesis is divided into a dense region and a porous region, and the porous region is filled with the molecular sieve functional motifs.
8. The method for preparing a medical implant based on molecular sieve functional elements according to claim 1, wherein the medical alloy used in the additive manufacturing in the step (4) is at least one of medical pure titanium, medical TC4, Ti-Nb series, Ti-Mo series, Ti-Zr series, Ti-Nb-Hf series, Ti-Nb-Zr series medical beta-type titanium alloy, NiTi series shape memory alloy, CoCr series alloy and medical stainless steel;
the additive manufacturing equipment in the step (4) is one of CONCEPT LASER M2, EOS M280/290, SLMsolution 125/250/2802.0/500, RENISHAW 400, BLT-S320, Archam A2x, Archam Q20, QEBAM Lab200 and Qbeam 3D.
9. A medical implant based on molecular sieve functional elements prepared by the preparation method of any one of claims 1 to 8.
10. The molecular sieve functional element-based medical implant of claim 9, wherein the implant comprises one of a joint implant, a spinal implant, a shoulder implant, a craniomaxillofacial implant, an ankle implant, and a sternum implant;
the joint implant is a hip implant and a knee implant, the spinal implant is an internal fixation implant and a minimally invasive implant, the shoulder implant is a scapula implant, the craniomaxillofacial implant is a mandible implant and a skull implant, and the ankle implant is an ankle implant and a toe bone implant.
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