CN114617679A - Composite 3D printing implant prosthesis and preparation method thereof - Google Patents

Composite 3D printing implant prosthesis and preparation method thereof Download PDF

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Publication number
CN114617679A
CN114617679A CN202011463719.0A CN202011463719A CN114617679A CN 114617679 A CN114617679 A CN 114617679A CN 202011463719 A CN202011463719 A CN 202011463719A CN 114617679 A CN114617679 A CN 114617679A
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prosthesis
composite
printing
printer
physical connection
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秦如
李庆桐
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Runyuan Biotechnology Suzhou Co ltd
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Suzhou Nuoqiao Technology Co ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/28Bones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/3094Designing or manufacturing processes
    • A61F2/30942Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/44Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/442Intervertebral or spinal discs, e.g. resilient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/3094Designing or manufacturing processes
    • A61F2002/3097Designing or manufacturing processes using laser
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/3094Designing or manufacturing processes
    • A61F2002/30976Designing or manufacturing processes using hydrojet
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/3094Designing or manufacturing processes
    • A61F2002/30985Designing or manufacturing processes using three dimensional printing [3DP]

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Veterinary Medicine (AREA)
  • Cardiology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Neurology (AREA)
  • Physics & Mathematics (AREA)
  • Geometry (AREA)
  • Manufacturing & Machinery (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)

Abstract

The invention discloses a composite 3D printing implant prosthesis and a preparation method thereof, and the preparation method comprises the following steps: integrally designing the prosthesis and the composite layer physical connection structure through three-dimensional software to obtain a digital model of the prosthesis and the physical connection structure; uniformly mixing the base material powder and the composite powder according to a design proportion by using a stirrer, putting the mixture into a 3D printer, and printing and molding the digital model by using the 3D printer to obtain a prosthesis blank body with a physical connection structure; carrying out heat treatment or sintering molding on the blank; the manufacturing method provided by the invention solves the problem of poor performance of the prosthesis manufactured by the prior art due to the limitation of a single material.

Description

Composite 3D printing implant prosthesis and preparation method thereof
Technical Field
The invention relates to an implant prosthesis in the medical field, in particular to a composite 3D printing implant prosthesis and a preparation method thereof.
Background
The implant prosthesis is used as an apparatus product with the highest risk in medical apparatus, and has extremely high requirements on the material, biocompatibility, machinery, chemistry and other aspects of the prosthesis due to long-term implantation in a human body, so that the application of the implant prosthesis material is very limited, and the implant prosthesis is limited by the material in different degrees in performance and function.
Currently, the academic and market accepted implant-grade biocompatible metal materials mainly include five elements of titanium, zirconium, niobium, tantalum and platinum and compounds thereof. In addition, in medical practice in different fields and clinical use for long-term implantation into human body, some materials with poor biocompatibility are still widely adopted due to the superior performance. For example, in the field of orthopedics, the bone friction surface of the traditional artificial joint is a cobalt-based alloy, and the wear resistance of the traditional artificial joint is far higher than that of titanium, tantalum and alloys, so the cobalt-based alloy is still widely used in the application of modern artificial joints. Besides metal materials, high molecular materials such as ultra-high molecular weight polyethylene, polyetheretherketone and the like are widely applied in the orthopedic field due to good biocompatibility and good physicochemical properties.
Implant prostheses of a single material are limited in their limited properties and use, for example, although the cobalt-based alloys mentioned above as bone friction surfaces have attracted considerable attention from orthopaedics doctors due to reports of toxicity of their products of corrosion or abrasion (cobalt ions, particles) to host bones and soft tissues, the wear resistance of other biocompatible materials is not better than that of the cobalt-based alloys except for the Zirconium-niobium alloy (Oxidized Zirconium) whose surface is vitrified, so that most of the global manufacturers still use the cobalt-based alloys for artificial joint wear-resistant surfaces so far because the products are not used in the market by extensive instrument manufacturers due to their high price and technical barriers. The research direction of the industry at present develops towards making a biological fixation surface on a cobalt-based alloy, but the porous structure of the biological fixation surface directly contacts with bones and is more faced with the problem of cobalt ion release, and the common solution of the industry at present is to adopt a coating technology to 'encapsulate' the cobalt-based alloy, but the problem cannot be fundamentally solved.
The rise of 3D printing related technologies provides a new approach to the production of medical instruments, which has a broad prospect for application in the medical field due to its customizability. Selective Laser Melting (SLM) or Electron Beam Melting (EBM) 3D printing techniques are a common method for rapid prototyping of metallic materials, where complex parts can be printed layer by Selective sintering or Melting of metal powders. This technique has begun to be clinically tested on acetabular cups of prosthetic joints, spinal interbody cages, and is beginning to be commercially available on custom-made products. The structural principle of the 3D printing technology determines that the printing of composite materials at different parts cannot be carried out. The Binder Jetting (BJ) technology is a new 3D printing technology, and is a rapid printing technology that a green body is formed by stacking Binder Jetting layers, then the Binder is removed from the green body, and the green body is sintered for one-step forming. Because a plurality of nozzles and material boxes can be designed structurally in the 3D printing mode, a plurality of materials can be adopted to realize the function of composite 3D printing, the function is still in an early stage, a plurality of metal printing cannot be realized, but the prospect and the technology are good. The Directional Energy Deposition (DED) blank forming technology is used to directly heat, melt and deposit wires or powder into a required structure through a heat source, and is mainly applied to the field of repair, such as the repair of damaged parts of aero-engines and the like, and is rarely applied to the medical field.
The method for composite 3D printing of the implant prosthesis is provided, and composite 3D printing is realized by three different 3D printing technologies, namely selective laser melting or electron beam melting, adhesive spraying and directional energy deposition technologies, so that the composite 3D printing implant prosthesis and the preparation method thereof are produced. The implant prosthesis has the advantages of various materials in the composite material, and the design can be greatly expanded, so that the development of a novel implant prosthesis becomes possible. For example, the problem of toxic ion release of the biological fixing surface of the cobalt-based alloy can be solved by adopting selective laser melting or electron beam melting 3D printing of a titanium alloy matrix containing the biological fixing surface, then adopting a directional energy deposition 3D printing technology to compound a cobalt-based alloy wear-resistant layer, or directly adopting an adhesive spraying mode, using a multi-nozzle 3D printer to print a composite material implant prosthesis of the cobalt-based alloy wear-resistant layer and the titanium alloy matrix, and sintering for one-step forming. In addition, for the surface ceramic Zirconium niobium alloy (Oxidized Zirconium) prosthesis similar to the above-mentioned one, such as the implant prosthesis with a biological fixing surface by single 3D printing, the product fails by adopting the oxidation technology because the product is Oxidized in the whole during the oxidation process, so that the porous structure of the biological fixing surface is ceramic, and the product is easy to crack, which is one of the reasons for the surface ceramic implant prosthesis without the biological fixing surface on the market for many years. The problem can be solved by adopting a composite 3D printing technology, and the specific preparation method can be referred to the relevant description of the invention. In addition, the composite mode can also select materials with trace elements added in the base material, so that the base material has special functions of the trace elements, for example, the prosthesis has a certain antibacterial function by adding a small amount of copper in the titanium alloy base, the bone ingrowth can be promoted by adding a certain proportion of hydroxyapatite (main bone components), and the functions of the implant prosthesis can be well expanded by the composite materials.
Disclosure of Invention
The invention aims to solve the problems in the prior art and provides a manufacturing method of a composite 3D printed implant prosthesis, which adopts the following technical scheme:
a manufacturing method of a composite 3D printing implant prosthesis comprises the following steps:
s1: designing an implant prosthesis (1) through three-dimensional software to obtain a digital prosthesis model, wherein a prosthesis blank body is provided with a composite surface (101), and the composite surface (101) is provided with a physical connection structure or is not provided with the physical connection structure;
s2-1: mixing base material powder for 3D printing and one or more than one composite powder according to a designed proportion, sequentially placing the mixture in stirring equipment, fully and uniformly mixing to obtain composite 3D printing composite powder, loading the composite 3D printing composite powder into a machine body of a 3D printer, and integrally printing and molding the digital prosthesis model obtained in the step S1 by using the 3D printer to obtain a prosthesis blank;
s2-2: respectively placing base material powder or wire materials for 3D printing and one or more than one composite powder or wire materials (the number of material boxes, the number of spray heads and the expansion of related components and functions of the 3D printer are carried out according to the number of the composite materials) into a plurality of material boxes of the 3D printer, and integrally printing and molding the digital prosthesis model obtained in the step S1 by using the 3D printer to obtain a prosthesis blank;
s3: putting the primary preformed prosthesis obtained in the step S2-1 into a heat treatment furnace for heat treatment; degreasing the primary preformed prosthesis obtained in the step S2-2 in a degreasing furnace, and sintering the degreased primary preformed prosthesis in a sintering furnace; obtaining a secondary preformed prosthesis;
s4, when the material of the secondary preformed prosthesis obtained in the step S3 is titanium alloy or zirconium-niobium alloy and the prosthesis needs surface ceramic treatment, putting the secondary preformed prosthesis into a heat treatment furnace for surface oxidation treatment, and not performing the operation on the prosthesis made of other materials to obtain a tertiary preformed prosthesis;
s5: removing the oxide layer formed by oxidizing the surface of the composite surface (101) in the step S4 by machining the secondary preformed prosthesis which is subjected to the surface oxidation treatment in the step S4 and does not have the physical connection structure in the step S1, and not performing the operation on the third preformed prosthesis which is not subjected to the surface oxidation treatment in the step S3 or is subjected to the oxidation treatment in the step S3 and has the physical connection structure in the step S1 to obtain a fourth preformed prosthesis;
s6: putting the quadruply preformed prosthesis obtained in the step S4 into a 3D printer, fixing the prosthesis by using a special clamp, exposing a composite surface (101) in a laser head processing area, and printing a porous surface structure or a solid material on the area needing to be processed to obtain a composite forming prosthesis;
further to the above technical solution, in step S1, the prosthesis blank has a physical connection structure,
furthermore, the physical connection structure (fig. 3) of the prosthesis is composed of a plurality of holes, the holes are reverse trapezoidal grooves, the diameter of the opening of the connection groove is 100-.
Further, in step S2-1, the 3D printer includes: a 3D printer for selective laser melting and a 3D printer for selective electron beam melting; in step S2-2, the 3D printer includes: the binder jetting technology is a green body forming printer respectively provided with 3D printing powder and a binder.
Furthermore, the 3D printer adopting the adhesive injection technology is provided with a plurality of spray heads, and the plurality of spray heads are connected with different powder material boxes.
Further, in step S2-1, the stirring device is preferably a ball mill, the ball mill is sealed and vacuumized, and then protective gas, preferably argon gas, is filled into the ball mill, and then the ball mill is uniformly stirred to obtain the composite material 3D printing powder.
Further, in step S3, the green body is placed in a vacuum furnace to be sintered and formed, and the melting points of different composite powders should be similar and the powders have the same sintering temperature; the sintering temperature of the green body in the vacuum furnace is lower than the melting point of the composite material.
Further, in step S4, when surface ceramization is required, the secondary preform prosthesis is subjected to surface oxidation treatment in a high temperature oxygen-containing heat treatment furnace.
Further, in step S5, the prosthesis, which has no physical connection structure and needs to be removed from the ceramic surface on the composite surface, is machined to remove the prosthesis, so as to ensure that the ceramic surface is removed from the composite surface and then the composite is performed, thereby improving the bonding strength between the matrix and the composite material.
Further, in step S6, the special fixture is integrated with a two-axis motion power device, so that in addition to the three-axis motion of the nozzle, five-axis linkage processing can be realized, and thus 3D printing can be performed according to any designed structure, and solid or porous composite material parts with different structures can be printed on the substrate.
Further, in step S6, the 3D printer includes: the directional energy deposition technology blank forming 3D printer.
The invention also provides a prosthesis of the spinal disc vertebral body joint implant prepared by the technical scheme, the prosthesis is provided with a prosthesis fixing surface and a contact surface, the contact surface comprises a friction surface or a sliding surface,
further, the prosthesis fixing surface comprises a porous three-dimensional structure surface and a non-porous rough surface;
furthermore, the friction surface is a zirconia or titania ceramic surface obtained by carrying out surface oxidation treatment on the prosthesis substrate, and a friction surface composite layer is printed out by adopting wear-resistant material composite 3D;
further, the prosthesis fixing surface and the prosthesis base body are formed in a composite 3D printing mode;
further, the base material of the prosthesis comprises one or more of zirconium-niobium alloy, titanium and titanium alloy.
The invention also provides the use of an implant prosthesis for prosthetic joints, spinal and trauma-type implant products, and other medical-type implant products in need of composite materials.
Compared with the prior art, the invention has one or more of the following beneficial effects:
1. the implant prosthesis made of the composite material is prepared by different 3D printing modes, and due to the adoption of the composite material, the function of the prosthesis can be expanded or the related performance can be improved, so that the limitation of the use of implant-level materials is relieved to a great extent, and the design is greatly expanded; the implant prostheses fabricated include, but are not limited to, prosthetic joints, spinal and trauma type products, and other medical type implant products requiring composite materials.
2. The invention utilizes the composite 3D printing technology to prepare the prosthesis with a ceramic friction surface or sliding surface and a biological fixed porous three-dimensional structure surface, solves the problem that the surface of the prosthesis is completely oxidized and ceramic (the ceramic porous structure can seriously affect the strength and toughness of the prosthesis matrix), thereby solving the problem that the traditional 3D printing technology can not prepare the biological fixed surface of the surface ceramic prosthesis, and the prosthesis has the surface ceramic friction or sliding surface, and simultaneously, the biological fixed surface can also select the composite material which has high biocompatibility and good bone combination with the same or different matrix material, such as hydroxyapatite with a certain proportion.
3. The prosthesis prepared by the preparation method comprises one or more of a friction surface or a sliding surface and a biological fixing surface with a rough or porous surface; the friction surface of the prosthesis is an oxide with ceramic performance on the surface obtained by high-temperature oxidation treatment, or a composite material layer which is formed by compounding 3D printing with a wear-resistant material; the biological fixing surface of the prosthesis is a rough or porous structure which keeps the characteristics of the composite material, so that different parts of the prosthesis have different physical and chemical properties, the use performance is improved, and the prosthesis can better meet the requirements of human body environment in the use process through targeted modification.
4. The forming method of the prosthesis and the composite material comprises the following steps: a selective laser melting 3D printing method; a selective electron beam melting 3D printing method; adhesive jetting technology 3D printing; a 3D printing method for forming the blank by a directional energy deposition technology;
5. the principle of the manufacturing method is that a substrate is printed in a 3D mode, then the substrate with the ceramic surface or without the ceramic surface is placed in a specific clamp to achieve 3D printing of the composite material, and therefore the part, which is not allowed to be oxidized, of the ceramic substrate can be prepared through composite 3D printing, the problem that printing of a single material cannot be solved is solved, and the preparation of the composite material prosthesis with different materials compounded on one prosthesis is achieved for the substrate without the ceramic surface.
6. The other manufacturing method of the invention adopts the principle of 3D printing by adopting an adhesive injection technology, a printer is provided with a plurality of nozzles which are connected with different powder material boxes, 3D printing powder and an adhesive are paved into a blank layer by layer, and the blank is finally formed by the processes of removing the adhesive, sintering and the like after being integrally formed, thereby being capable of printing implant prostheses with different materials at different parts. The sintering temperature of the composite material is required to be consistent by the technology, so that the melting points of different materials are close, and the method is not suitable for different materials with large difference of the melting points.
7. Due to the addition of the composite material in the manufacturing method, the performance of the prosthesis can be enhanced or new functions are brought to the prosthesis, for example, the mechanical performance of the composite part of the prosthesis can be enhanced by adopting cobalt-based alloy composite 3D printing on the upper part of the titanium alloy substrate; the addition of copper element in the matrix can make the prosthesis have certain antibacterial performance, and the addition of hydroxyapatite in certain proportion can make the prosthesis have better compatibility with bone, and the like.
8. In the manufacturing method, the physical connecting mechanism is designed in the prosthesis substrate and the composite layer, so that the bonding strength of different materials after being compounded is better, and the mechanical performance similar to integral molding is achieved;
9. the prosthesis and the forming method of the composite material can realize that the prosthesis better meets physical and chemical characteristics required by a human body, and compared with the prosthesis prepared by the prior art, the prosthesis prepared by the invention is more suitable for the human body environment and has more practicability;
10. the manufacturing method is mainly realized preliminarily by using computer software and a 3D printer, the step is easy to realize in terms of the speed of the current technology development, and the realization of the step is more and more convenient along with the progress of the technology, so that the manufacturing method is in line with the era, the technology is promoted to be improved, the technology development is promoted to be improved, and a virtuous circle is formed.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present invention, and other drawings can be obtained by those skilled in the art without creative efforts.
FIG. 1 is a schematic view showing the overall structure of the prosthesis according to the embodiment of the present invention;
FIG. 2 is a schematic illustration of a fixation surface;
FIG. 3 is a schematic structural diagram of the physical connection structure in the embodiment of the present invention;
FIG. 4 is a schematic structural view of a biological immobilization support having a porous structure.
Wherein, 1-prosthesis, 101-compound surface, 2-fixing surface.
Detailed Description
The technical solutions of the embodiments of the present invention will be described below in detail by referring to the drawings of the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
The principle of the method for preparing the implant prosthesis by the composite 3D printing technology provided by the invention is as follows:
firstly, in the design process of the prosthesis, a physical connection structure is endowed to the composite surface of the prosthesis;
secondly, after different 3D printing powders are vacuumized and added with protective gas, the mixture is fully and uniformly stirred, and then is put into a 3D printer or different required composite material printing powders are filled into different material boxes so as to realize that different nozzles extrude different printing materials for composite 3D printing;
thirdly, carrying out heat treatment or sintering on the prosthesis after printing and forming;
fourthly, carrying out high-temperature heat treatment on the molded prosthesis needing surface ceramic in oxygen-containing gas, and not carrying out the operation on the prosthesis not needing surface ceramic;
fifthly, the prosthesis formed through surface ceramic or non-surface ceramic is placed into a 3D printer to be printed with local composite materials, and finally the composite material implant prosthesis is formed.
The implant prosthesis is applied to different prosthesis components of artificial joints, spines and trauma type implants.
The gist of the present invention will be further explained below with reference to the accompanying drawings and examples.
Example 1:
the invention provides a method for manufacturing an implant prosthesis by combining Selective Laser Melting (SLM) or Electron Beam Melting (EBM) with a Directional Energy Deposition (DED) blank forming technology, which comprises the following steps:
firstly, an engineer designs a prosthesis 1 and a prosthesis compound surface 101 with a physical connection structure, and the prosthesis compound surface is converted into a digital model which can be formed by 3D printing, wherein the physical connection structure is a plurality of holes which are uniformly distributed on the compound surface, the holes are inverted trapezoidal connection grooves, the diameter of the opening part of each connection groove is 100 + 300um and the depth is 300 + 800um, and the diameter of the bottom part of each connection groove is smaller than that of the opening part of each groove, as shown in FIG. 3;
adding 1% -10% of nano-copper composite material powder into the matrix 3D printing powder, putting the mixture into stirring equipment, preferably adopting a ball mill for stirring, sealing and vacuumizing the ball mill, then refilling protective gas, preferably filling argon for protection, and then uniformly stirring by using grinding balls to obtain composite material 3D printing powder;
placing the composite material 3D printing powder into a selective laser melting or selective electron beam melting 3D printer, inputting the digital models of the prosthesis 1 and the physical connecting structure 101 into the 3D printer, starting the printer to print, and forming the prosthesis 1 and the physical connecting structure 101 on the composite surface in one step;
then the prosthesis 1 is placed into a high-temperature oxygen-containing heat treatment furnace for surface oxidation treatment to obtain a secondary pre-formed surface ceramic-treated prosthesis;
removing the ceramic surface on the composite surface of the prosthesis by adopting a machining mode for the prosthesis without a physical connection structure on the composite surface;
placing the prosthesis 1 on a special fixture in a directional energy deposition 3D printer, and compounding a 3D printing entity or a porous structure on a compounding surface according to a designed digital model;
finally, the composite prosthesis is subjected to the necessary post-treatments, such as polishing, washing, etc., to obtain a fully formed prosthesis.
The invention also provides a biological fixation artificial intervertebral disc artificial vertebral body joint prosthesis prepared by the preparation method, as shown in figure 1, the artificial vertebral body core component prosthesis 1 is provided with a friction surface or a sliding surface and a fixing surface 2;
the friction surface or the sliding surface is a zirconia or titania ceramic surface obtained by performing surface oxidation treatment on the base body of the prosthesis 1, and the friction surface or the sliding surface has a sliding effect;
the prosthesis fixing surface 2 comprises a porous surface or a non-porous rough surface, and the prosthesis fixing surface 2 is used for biological fixation with host bones;
the prosthesis fixing surface 2 and the prosthesis base body 1 are formed by composite 3D printing, the composite surfaces are connected by a physical connecting structure or a ceramic layer is removed by a machining mode, the bonding among the molecules of the composite material is achieved through the molten state in the 3D printing, and the prosthesis fixing surface 2 keeps the physical and chemical properties of the selected composite material;
the base material of the prosthesis 1 comprises one or more combinations of magnesium, zirconium-niobium alloy, titanium and titanium alloy, and the composite material comprises one or more combinations of titanium, titanium alloy, tantalum, copper, polyether ether ketone and hydroxyapatite.
The prosthesis prepared by the invention comprises one or more of a porous surface or a non-porous rough surface for biological fixation with host bones and a friction surface or a sliding surface for playing a sliding role, wherein the friction surface is zirconia or titania ceramics generated by carrying out high-temperature oxidation treatment on the surface of a substrate, and the biological fixation surface of the prosthesis is formed by compounding a 3D printing method and the prosthesis substrate. The principle is that firstly, the composite surface of the substrate has a physical connection structure in the 3D printing and forming process, the biological fixing surface is printed through composite 3D after high-temperature oxidation treatment, the physical connection structure can ensure the bonding strength between the substrate and the biological fixing surface, the biological fixing surface of the prosthesis keeps the physical and chemical properties of the composite material, and the material which is the same as or different from the substrate can be selected.
Example 2:
the invention provides a method for manufacturing an implant prosthesis based on Binder Jetting (BJ) 3D printing, which comprises the following steps:
firstly, a design engineer designs the prosthesis 1 and a friction surface or a sliding surface of the prosthesis, and converts the prosthesis 1 and the friction surface or the sliding surface into a digital model which can be formed by 3D printing, wherein a base body of the prosthesis 1 and the friction surface or the sliding surface are made of different materials;
inputting the digital models of the physical connection structures of the prosthesis 1, the friction surface or the sliding surface of the prosthesis and the composite surface into blank forming printers respectively provided with different 3D printing powder material boxes, starting the printers, and forming the blank of the prosthesis and the friction surface or the sliding surface at one time;
placing the blank in a degreasing furnace to remove the adhesive;
placing the blank in a vacuum furnace for sintering and molding;
the prosthesis 1 is placed on a special fixture in a directional energy deposition 3D printer, and a 3D printing entity or a porous structure is compounded on a compound surface according to a designed digital model.
Finally, the prosthesis 1 is subjected to the necessary post-treatments, such as polishing, washing, etc., to obtain a fully formed prosthesis.
In the above embodiment, the binder on the surface of the green body can be removed by using a degreasing furnace through the principle of similar compatibility.
In the above embodiment, the blank integrally formed by the composite material may be sintered by a vacuum sintering furnace to obtain a formed prosthesis.
With reference to the above embodiments 1-2, the composite 3D printed implant prosthesis and the preparation method thereof provided by the invention practically solve the problems in the prior art, and provide a prosthesis with better performance and better compliance with the requirements of human body environment for the medical field.
The implant prosthesis made of the composite material is prepared by different 3D printing modes, and due to the adoption of the composite material, the corresponding new functions are expanded or the prosthesis with the phase performance improved, so that the limitation of the use of the implant-level material is solved to a great extent, and the design is greatly expanded; the implant prostheses fabricated include, but are not limited to, prosthetic joints, spinal and trauma type products, and other medical type implant products requiring composite materials.
The invention utilizes the composite 3D printing technology to prepare the prosthesis with a ceramic friction surface or sliding surface and a biological fixed porous three-dimensional structure surface, solves the problem that the surface of a matrix is completely oxidized and ceramic (the ceramic porous structure can seriously influence the strength and toughness of the prosthesis matrix), thereby solving the problem that the traditional 3D printing technology can not prepare the biological fixed surface of the surface ceramic prosthesis, and the prosthesis has the wear-resistant surface ceramic friction or sliding surface, and simultaneously, the biological fixed surface can also select the composite material which has the same or different material with the matrix material and has high biocompatibility and physical and chemical properties required by bone combination.
The prosthesis prepared by the preparation method of the invention contains one or more of a friction surface or a sliding surface and a biological fixing surface with rough or porous surface; the friction surface of the prosthesis is an oxide which is similar to ceramic performance and directly grows from a base body through high-temperature oxidation heat treatment, the biological fixing surface of the prosthesis keeps the rough or porous structure of the metal chemical components of the base body, so that different parts of the prosthesis have different physical and chemical properties, the service performance is improved, and the prosthesis is more in line with the requirements of human body environment in the using process through targeted transformation.
In the manufacturing method, due to the addition of the composite material, the performance of the prosthesis can be enhanced or new functions can be added to the prosthesis, for example, the mechanical performance of the composite part of the prosthesis can be increased by adopting cobalt-based alloy composite 3D printing on the upper part of the titanium alloy substrate; the addition of copper element in the matrix can make the prosthesis have a certain antibacterial property, and the addition of hydroxyapatite in a certain proportion can make the prosthesis have better compatibility with bone, etc. to give the prosthesis new functions or improve its characteristics.
In the manufacturing method, the physical connecting mechanism is designed in the prosthesis substrate and the composite layer, so that different materials can be bonded better, and the mechanical properties such as tensile strength can reach a high level;
the prosthesis and the forming method of the composite material can realize that the physical and chemical properties of the prosthesis are more in line with the requirements of the human body, and compared with the prosthesis prepared by the prior art, the prosthesis prepared by the invention is more suitable for the environment of the human body and has more practicability;
the manufacturing method is mainly realized preliminarily by using computer software and a 3D printer, the step is easy to realize in terms of the speed of the current technology development, and the realization of the step is more and more convenient along with the progress of the technology, so that the manufacturing method is in line with the era, the technology is promoted to be improved, the technology development is promoted to be improved, and a virtuous circle is formed.
In the description herein, references to the description of the term "one embodiment," "some embodiments," "an example," "a specific example" or "some examples" or the like are intended to mean that a particular feature, structure, material, or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of the invention. In this specification, the schematic representations of the terms used above are not necessarily intended to refer to the same embodiment or example. Furthermore, the particular features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples. Furthermore, various embodiments or examples described in this specification can be combined and combined by one skilled in the art.
While embodiments of the present invention have been shown and described above, it is to be understood that the above embodiments are exemplary and not to be construed as limiting the present invention, and that changes, modifications and variations may be made therein by those of ordinary skill in the art within the scope of the present invention.

Claims (9)

1. A composite 3D printing implant prosthesis and a preparation method thereof are characterized by comprising the following steps:
s1: the method comprises the steps of designing an implant prosthesis (1) through three-dimensional software to obtain a digital prosthesis model, wherein a composite surface (101) is arranged on a prosthesis blank body, and a physical connection structure or no physical connection structure is arranged on the composite surface (101);
s2-1: mixing base material powder for 3D printing and one or more than one composite powder according to a designed proportion, sequentially placing the mixture into stirring equipment, fully and uniformly mixing the mixture to obtain composite 3D printing composite powder, filling the composite 3D printing composite powder into a machine body of a 3D printer, and integrally printing and molding the digital prosthesis model obtained in the step S1 by using the 3D printer to obtain a prosthesis blank;
s2-2: respectively placing base material powder or wire materials for 3D printing and one or more than one composite powder or wire materials (the number of material boxes, the number of spray heads and the expansion of related components and functions of the 3D printer are carried out according to the number of the composite materials) into a plurality of material boxes of the 3D printer, and integrally printing and molding the digital prosthesis model obtained in the step S1 by using the 3D printer to obtain a prosthesis blank;
s3: putting the primary preformed prosthesis obtained in the step S2-1 into a heat treatment furnace for heat treatment; degreasing the primary preformed prosthesis obtained in the step S2-2 in a degreasing furnace, and sintering the degreased primary preformed prosthesis in a sintering furnace; obtaining a secondary preformed prosthesis;
s4, when the material of the secondary preformed prosthesis obtained in the step S3 is titanium alloy or zirconium-niobium alloy and the prosthesis has other requirements of wear resistance or similar coating, the secondary preformed prosthesis is placed into a heat treatment furnace for surface oxidation treatment, and the operation is not carried out on the prosthesis made of other materials, so that a tertiary preformed prosthesis is obtained;
s5: removing an oxide layer formed by oxidation on the surface of the composite surface (101) in the step S4 by machining the secondary preformed prosthesis subjected to the surface oxidation treatment in the step S4 and not having the physical connection structure in the step S1, and not performing the operation on the third preformed prosthesis which is not subjected to the surface oxidation treatment in the step S3 or is subjected to the oxidation treatment in the step S3 and has the physical connection structure in the step S1 to obtain fourth preformed prostheses;
s6: putting the quadruply preformed prosthesis obtained in the step S4 into a 3D printer, fixing the prosthesis by using a special clamp, exposing a composite surface (101) in a laser head processing area, and printing a porous surface structure or a solid material on the area needing to be processed to obtain a composite forming prosthesis;
2. method of manufacturing according to claim 1, characterized in that in step S1, the prosthesis (1) has a composite face (101) with a physical connection structure;
the physical connection structure is provided with a plurality of holes, the boundaries of the holes are reverse trapezoidal connection grooves, the diameter of the opening part of each connection groove is 100-300 mu m and the depth is 300-800 mu m, and the diameter of the bottom of each connection groove is smaller than that of the opening part of each groove;
prostheses that do not have physical attachment structures and require surface oxidation treatment require additional machining processes to remove the ceramized oxide surface on the composite surface (101).
3. The manufacturing method according to claim 1, wherein in step S2-1, the stirring device is preferably a ball mill, the ball mill is sealed and vacuumized, inert protective gas is charged into the ball mill, and after protection, the ball mill is used for uniform stirring to obtain the composite material 3D printing powder.
4. The manufacturing method of claim 1, wherein in step S2-2, the 3D printer has a magazine of multiple materials, and the magazine contains different powders or wires, so as to realize composite printing of different materials at different parts of the prosthesis according to design;
the 3D printer includes: step S2-1: selecting a laser melting 3D printer or an electron beam melting 3D printer; step S2-2: an adhesive jetting 3D printer; step S5: and (3) adopting a directional energy deposition technology to form a blank body.
5. The method of claim 1, wherein in step S4, the titanium and titanium alloy or zirconium-niobium alloy secondary preform prosthesis is subjected to surface oxidation treatment in a high temperature oxygen-containing heat treatment furnace to obtain a ceramic surface of zirconia or titania.
6. The method of manufacturing of claim 1, wherein in step S5, the triple preform prosthesis is machined to remove the ceramic oxide layer formed on the composite surface (101) in step S4.
7. The manufacturing method of claim 1, wherein in step S6, the special fixture for fixing the prosthesis in the 3D printer can perform two-axis motion, and the spray head for feeding can perform three-axis motion, and the two motions cooperate to achieve five-axis linkage, so that the purpose of composite printing can be performed on any part of the prosthesis according to design.
8. The manufacturing method of claim 1, wherein in step S6, the plurality of cavities in the physical connection layer are filled by 3D printing, and the composite layer is integrally printed, so as to form a physical connection structure layer, thereby enhancing mechanical properties such as adhesive strength between the composite material and the substrate.
9. Implant prosthesis obtained by the manufacturing method according to any one of claims 1 to 8, characterized in that said prosthesis (1) has one or more of a friction or sliding surface, a fixation surface and a composite surface (101);
the friction surface or the sliding surface is a zirconia or titania ceramic surface obtained by carrying out surface oxidation treatment on the base metal of the prosthesis (1) or a wear-resistant material layer printed on the base body by adopting a composite 3D printing mode;
the prosthesis fixing surface comprises a porous biological fixing surface or a non-porous rough surface, the porous biological fixing surface is a porous three-dimensional structure layer, the porosity of the porous biological fixing surface is 30% -90%, the average diameter range of pores is 0.1-0.9 mm, and the thickness range of the porous surface is 0.3-2.0 mm;
the friction surface or sliding surface and the fixed surface of the prosthesis and the prosthesis base body are formed in a composite 3D printing mode;
the prosthesis base material comprises one or more of magnesium, titanium alloy, tantalum alloy, zirconium-niobium alloy, cobalt-based alloy, copper, ultra-high molecular weight polyethylene, polyether-ether-ketone, hydroxyapatite and stainless steel; the composite material comprises one or more of titanium, titanium alloy, tantalum, cobalt-based alloy, copper, ultra-high molecular weight polyethylene, polyether ether ketone and hydroxyapatite.
CN202011463719.0A 2020-12-14 2020-12-14 Composite 3D printing implant prosthesis and preparation method thereof Pending CN114617679A (en)

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5478237A (en) * 1992-02-14 1995-12-26 Nikon Corporation Implant and method of making the same
CN105268977A (en) * 2015-11-05 2016-01-27 北京科技大学 Method for quickly manufacturing titanium alloy artificial biological joint
CN108014369A (en) * 2018-01-24 2018-05-11 山东建筑大学 A kind of preparation method of the compound bone material of renewable titanium-based
CN108950305A (en) * 2018-08-24 2018-12-07 山东建筑大学 A kind of preparation method of titanium alloy-hydroxy-apatite halite bioceramic porous material
CN110200727A (en) * 2019-07-01 2019-09-06 中国人民解放军第四军医大学 A kind of 3D printing tubular porous titanium prosthesis and preparation method thereof for four limbs large segmental bone defect
CN110575289A (en) * 2019-09-20 2019-12-17 重庆新索医药科技有限公司 3D printing method for bone defect prosthesis

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5478237A (en) * 1992-02-14 1995-12-26 Nikon Corporation Implant and method of making the same
CN105268977A (en) * 2015-11-05 2016-01-27 北京科技大学 Method for quickly manufacturing titanium alloy artificial biological joint
CN108014369A (en) * 2018-01-24 2018-05-11 山东建筑大学 A kind of preparation method of the compound bone material of renewable titanium-based
CN108950305A (en) * 2018-08-24 2018-12-07 山东建筑大学 A kind of preparation method of titanium alloy-hydroxy-apatite halite bioceramic porous material
CN110200727A (en) * 2019-07-01 2019-09-06 中国人民解放军第四军医大学 A kind of 3D printing tubular porous titanium prosthesis and preparation method thereof for four limbs large segmental bone defect
CN110575289A (en) * 2019-09-20 2019-12-17 重庆新索医药科技有限公司 3D printing method for bone defect prosthesis

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