CN113558829A - Biological fixation artificial joint prosthesis and manufacturing method and application thereof - Google Patents
Biological fixation artificial joint prosthesis and manufacturing method and application thereof Download PDFInfo
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- CN113558829A CN113558829A CN202010350825.1A CN202010350825A CN113558829A CN 113558829 A CN113558829 A CN 113558829A CN 202010350825 A CN202010350825 A CN 202010350825A CN 113558829 A CN113558829 A CN 113558829A
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- prosthesis
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Images
Classifications
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- A61F—FILTERS 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
- A61F2/00—Filters 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
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- A61F2/00—Filters 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
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- A61F2/00—Filters 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
- A61F2/02—Prostheses implantable into the body
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- A61F2/00—Filters 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
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- A61F2/00—Filters 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
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- A61F2/00—Filters 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
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- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
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- A—HUMAN NECESSITIES
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- A61F—FILTERS 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
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- A—HUMAN NECESSITIES
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- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00389—The prosthesis being coated or covered with a particular material
- A61F2310/00592—Coating or prosthesis-covering structure made of ceramics or of ceramic-like compounds
- A61F2310/00598—Coating or prosthesis-covering structure made of compounds based on metal oxides or hydroxides
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- A—HUMAN NECESSITIES
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- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Vascular Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Transplantation (AREA)
- Cardiology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Physics & Mathematics (AREA)
- Geometry (AREA)
- Manufacturing & Machinery (AREA)
- Prostheses (AREA)
- Materials For Medical Uses (AREA)
Abstract
The invention discloses a biological fixation artificial joint prosthesis and a manufacturing method and application thereof, and the method comprises the following steps: integrally designing the prosthesis and the protection device through three-dimensional software to obtain a digital model of the prosthesis and the protection device; printing and molding the digital model by using a 3D printer to obtain a blank body of the prosthesis and the protection device; cleaning residual impurities on the blank, drying, sintering and molding the blank, and sealing the holes on the prosthesis in vacuum to obtain a preliminarily molded prosthesis; grinding, polishing and cleaning the friction surface of the primarily formed prosthesis, and then putting the friction surface into a heat treatment furnace for surface oxidation treatment to obtain a basically formed prosthesis; removing the protective device from the substantially shaped prosthesis to obtain a fully shaped prosthesis, and post-treating the fully shaped prosthesis. The manufacturing method provided by the invention solves the problem of poor performance of the prosthesis manufactured by the prior art.
Description
Technical Field
The invention relates to an artificial joint in the medical field, in particular to a biological fixation artificial joint prosthesis and a manufacturing method and application thereof.
Background
The long-term safety and effectiveness of an artificial joint depends on two important factors: firstly, the fixation between the prosthesis and the host bone and the long-term stability of the prosthesis; ② the wear resistance of the joint sliding surface and the biocompatibility of the abrasive dust. Thus, over the past two decades, the history of prosthetic joint materials and prosthetic joint design has essentially expanded around both factors.
Nowadays, biological fixation technology represented by porous metal and friction pair technology represented by ceramics and high cross-linked ultra-high molecular weight polyethylene have become the accepted "gold standard" in the field of global artificial joints, and the bone fixation surface of modern artificial joints is basically coated by titanium, titanium alloy, tantalum or hydroxyapatite.
The bone fixing surface of the traditional artificial joint is cobalt-based alloy, but because the biocompatibility between the bone fixing surface and host bone is obviously inferior to that of metals such as titanium, tantalum and the like, the bone fixing surface of the traditional artificial joint is basically out of the material selection of the biological fixing surface of the modern joint.
However, if the cobalt-based alloy is used as a friction surface, the wear resistance of the cobalt-based alloy is far better than that of titanium, tantalum metal and alloy, so that the application of the cobalt-based alloy to modern artificial joints is basically limited to the friction surface or prostheses mainly fixed by bone cement, such as hip joint bulbs, knee joint cuboid condyles, tibial platforms and the like.
In recent years, cobalt-based alloy bulbs have attracted considerable attention from orthopaedics doctors because of reports of toxicity of corrosion or abrasion products (cobalt ions and particles) to host bones and soft tissues, and have been gradually replaced by ceramic bulbs or zirconium-niobium alloy bulbs with ceramic surfaces in markets of developed countries such as europe and the united states.
However, since ceramic materials have far inferior impact resistance to metallic materials, ceramic-based prostheses are still rarely used in knee replacements where the stress environment demands extreme demands, and surface-ceramized Zirconium-niobium alloys (Oxidized Zirconium) have been popular with physicians in clinical applications over the last two decades.
The main reasons why the zirconium niobium alloy prosthesis with ceramic surface is accepted by clinicians are its characteristics of wear resistance, corrosion resistance, impact fracture resistance and no risk of flaking. The main factors that confer these traits are attributed to their unique technical processes: firstly, the ceramic surface of the zirconium-niobium alloy is compact zirconia directly grown from a metal matrix through a special heat treatment process, and is not a traditional ceramic coating; secondly, a transition region which is naturally formed in the heat treatment process is arranged between the surface of the zirconia and the substrate, so that no obvious interface exists between the ceramic surface and the substrate.
In recent years, titanium-based alloys have also received some attention through heat treatment techniques similar to ceramization of the surface of zirconium-niobium alloys. Because titanium alloy is the most commonly used material of artificial joints and the price is far lower than that of zirconium-niobium alloy, the heat treatment technology based on the zirconium-niobium alloy or titanium alloy surface ceramization principle has more universal application value.
However, the heat treatment process for ceramization of metal surface of titanium-based alloy or zirconium-niobium alloy has the following characteristics: firstly, the base metal must be subjected to heat treatment at high temperature (higher than 500 ℃) in an environment containing oxidizing gas; ② the whole base metal is heat-treated, the whole surface of the prosthesis including the frictional surface and the fixing surface is inevitably oxidized.
After heat treatment, the porous metal surface of the bio-immobilized prosthesis, especially the prosthesis with the porous metal immobilization surface, is oxidized and ceramized, and the strength and toughness of the ceramized porous structure are seriously influenced. If the porous metal anchoring surface is bonded to the heat-treated prosthesis by high-temperature sintering or the like, the ceramized surface is seriously affected, so that this method of heat-treating the entire base metal in an atmosphere containing an oxidizing gas is not feasible.
Although clinical practice has been experienced for more than two decades, the resurfaced zirconium niobium alloy prosthesis has only one form of bone cement fixation in knee replacement, and a non-bone cement bio-fixation form has not been realized, and further, in the state of the art, the problem of solving the oxidation prevention of the porous surface of zirconium niobium alloy or titanium alloy during high temperature heat treatment still remains.
Therefore, it is necessary to provide a new technical solution to solve the above problems, so as to realize that the zirconium niobium alloy or the titanium alloy has both the ceramic friction surface and the original metallic porous surface.
Disclosure of Invention
The invention aims to solve the problems in the prior art and provides a method for manufacturing a biological fixation artificial joint prosthesis, which adopts the technical scheme that:
a method for manufacturing a biological fixation artificial joint prosthesis comprises the following steps:
s1: designing a prosthesis with a protection device through three-dimensional software to obtain a digital prosthesis model;
s2: integrally printing and molding the digital prosthesis model obtained in the step S1 by using a 3D printer to obtain a prosthesis blank, wherein the prosthesis blank is provided with a fixing surface and a friction surface;
s3: cleaning residual impurities of the prosthesis blank obtained in the step S2, drying, sintering, and sealing the hole of the protection device on the sintered prosthesis blank under a vacuum condition to obtain a primary preformed prosthesis;
s4: grinding, polishing and cleaning the friction surface of the primary preformed prosthesis obtained in the step S3, and then placing the friction surface into a heat treatment furnace for surface oxidation treatment to obtain a secondary preformed prosthesis;
s5: and removing the protective device on the secondary preformed prosthesis obtained in the step S4 to obtain the molded prosthesis.
Further to the above technical solution, in step S2, the prosthesis blank has a prosthesis fixing surface,
furthermore, a sealing protection device is arranged on the prosthesis fixing surface, one or more holes are formed in the protection device, and the diameter of each hole is larger than 0.5 mm; a channel is arranged between the protection device and the prosthesis fixing surface, and the width range of the channel is 0.5 mm-50 mm;
the prosthesis blank is formed by laying prosthesis base metal powder and selective caking agent layer by layer and depositing;
further, in step S2, the prosthesis blank further includes an anti-sintering isolation layer;
furthermore, the sintering-proof isolation layer is arranged between the prosthesis fixing surface and the protection device and comprises a high-temperature-resistant ceramic material;
further, in step S2, the 3D printer includes: the device comprises a selective area laser melting 3D printer, a selective area electron beam melting 3D printer, a blank forming printer and a blank forming 3D printer, wherein the blank forming printer is respectively filled with metal powder and a binder;
further, one of the double spray heads sprays the mixture, and the other of the double spray heads sprays the sintering-proof ceramic material;
further, the mixture comprises a mixture of metal powder and a binder mixed according to a certain proportion.
Further, in step S3, the residual impurities include free loose metal dust attached to the blank, dust particles between the prosthesis fixing surface and the protective layer, and a binder on the blank surface;
further, after the blank is placed in a vacuum furnace for sintering and molding, sealing the holes on the protection layer of the blank in vacuum;
further, removing free loose metal dust attached to the green body and dust particles between the fixing surface of the prosthesis and the protective layer by a physical method through vacuum and/or electrostatic adsorption;
further, removing the binder on the surface of the blank by using a chemical solvent through a similar intermiscibility principle;
further, the sintering temperature of the green body in the vacuum furnace is lower than the melting point of the metal material;
further, the holes in the green body protection layer are sealed through laser welding.
Further, in step S4, the primary preform prosthesis is subjected to a surface oxidation treatment in a high-temperature oxygen-containing heat treatment furnace.
Further, in step S5, the secondary preformed prosthesis is machined to remove the protective device.
The invention also provides a biological fixation artificial joint prosthesis 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 metal surface and a nonporous rough metal surface;
further, the friction surface is a zirconia or titania ceramic surface obtained by subjecting a base metal of the prosthesis to surface oxidation treatment;
further, the prosthesis fixing surface and the prosthesis base body are integrally molded;
further, the base metal material of the prosthesis comprises one or more of zirconium niobium alloy, titanium and titanium alloy.
The invention also provides the application of the biological fixation artificial joint prosthesis, and the artificial joint prosthesis is applied to the cuboid condyle and the tibial plateau of the biological fixation knee joint, the acetabular cup of the biological fixation hip joint and the ball head of the surface replacement hip joint.
Compared with the prior art, the invention has one or more of the following beneficial effects:
1. the prosthesis fixing surface which does not need surface oxidation treatment is isolated and protected by the protection device, so that the base metal of the prosthesis does not reach the prosthesis fixing surface when the surface oxidation treatment is carried out, and the strength and the toughness of the material at the prosthesis fixing surface are ensured;
2. compared with the prosthesis prepared by the prior art, the prosthesis prepared by the preparation method has a ceramic friction surface and a porous surface with the characteristics of original metal, solves the problems that the metal surface of a base body is completely oxidized and ceramic is generated by improving the processing mode, and the strength and the toughness of the prosthesis base body are seriously influenced by the ceramic porous structure;
3. the prosthesis prepared by the preparation method of the invention comprises 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, and the biological fixing surface of the prosthesis is a rough or porous structure which keeps chemical components of base body metal, so that different parts of the prosthesis have different physical 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;
4. the principle of the manufacturing method is that the part of the prosthesis which does not need surface oxidation is isolated by the protection device, and in the manufacturing process, the protection device and the prosthesis are integrally formed, so that the sealing performance is better, the isolation effect is better, and only the part of the base metal of the prosthesis exposed outside the protection device is ensured to be oxidized;
5. in the manufacturing method, because the prosthesis protection device is used, the prosthesis fixing surface is isolated from oxygen or active gas, so that no chemical reaction exists, and sintering cannot be generated between the biological fixing surface and the protection layer of the prosthesis again due to the existence of the sintering-resistant ceramic layer, so that the biological fixing surface and the protection layer can be separated after heat treatment without changing the chemical and physical properties of the fixing surface;
6. in the manufacturing method of the invention, the prosthesis protection device can be removed from the prosthesis by machining, for example, a peripheral sealing layer of the prosthesis protection device is removed by linear cutting, and the protection device after peripheral cutting can be easily separated from the prosthesis due to a channel with a certain width between the biological fixing surface of the prosthesis and the protection layer or a sintering-proof isolation layer;
7. the prosthesis prepared by the preparation method of the invention is a prosthesis with both friction surface function and bionic fixation surface function, including but not limited to artificial knee joint cuboid condyle, artificial knee joint tibial platform with double sliding design, artificial hip joint acetabular cup with double sliding design, hip joint cuboid bulb for surface replacement, etc.; the prosthesis has the performances of wear resistance and corrosion resistance of a ceramic friction surface, and also retains the performance of a biological fixing surface with the chemical characteristics of a base metal for promoting bone growth or bone ingrowth;
8. the forming method of the prosthesis and the protection device comprises the following steps: a selective laser melting 3D printing method; a selective electron beam melting 3D printing method; the method comprises the steps of spreading powder (basal body metal powder of prosthesis) layer by layer and adding selective caking agent for deposition to form a blank, and then sintering at high temperature in vacuum to finally form the blank; a method of printing a blank layer by extruding a mixture of metal powder and a binder through a nozzle, and adding a layer of high-temperature sintering-resistant ceramic powder between a biological fixing surface of the prosthesis and an anti-oxidation protection device;
9. the forming method of the prosthesis and the protection device can realize that the physical and chemical properties of the matrix metal and the original geometric shape of the bionic fixing surface of the biological matrix and the fixing surface can be kept in the subsequent sintering and high-temperature oxidation processes, 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 of the overall structure of the prosthesis and the protection device according to the embodiment of the present invention;
FIG. 2 is a schematic view of the prosthesis and the protector showing the holes of FIG. 1 sealed;
FIG. 3 is a schematic representation of the prosthesis of an embodiment of the present invention after it has been fully formed;
FIG. 4 is a schematic view showing the overall structure of a prosthesis and a protector having an anti-sintering insulation layer according to example 3 of the present invention;
fig. 5 is a schematic view of the structure of fig. 4 with the protective device removed.
Wherein, 1-prosthesis, 11-friction surface, 2-protective device, 3-hole, 4-prosthesis fixing surface, and 5-anti-sintering isolation layer.
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.
Because the prosthesis prepared by the prior art is oxidized at the same time when being subjected to high-temperature surface oxidation treatment, the metal characteristics of the prosthesis fixing surface are influenced, the strength and the toughness of the prosthesis fixing surface are influenced, and the service performance is reduced, the invention provides a new technical scheme to solve the problems.
The principle of the method for preparing the biological fixation artificial joint prosthesis provided by the invention is as follows:
firstly, in the design process of the prosthesis, a sealing protection device for preventing high-temperature oxidation is endowed to the fixed surface of the prosthesis;
secondly, the prosthesis and the anti-oxidation protection device are integrally formed by a digital additive manufacturing or 3D printing method;
thirdly, performing primary polishing treatment on the friction surface of the prosthesis after printing and forming;
fourthly, carrying out high-temperature heat treatment on the molded printing piece in oxygen-containing gas;
fifthly, removing the sealing protection device of the printed piece after heat treatment;
sixth, the prosthesis after removal of the protective device is subjected to necessary post-treatments such as polishing, washing, etc.
The base material of the prosthesis prepared by the manufacturing method is zirconium-niobium alloy or titanium and titanium alloy, and the prosthesis comprises 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 directly grown from a substrate through high-temperature oxidation heat treatment and has similar ceramic performance, and the biological fixing surface of the prosthesis is a rough or porous structure which keeps the chemical components of the metal of the substrate.
The gist of the present invention will be further explained below with reference to the accompanying drawings and examples.
Example 1:
referring to fig. 1-3, the present invention provides a method for forming a bio-fixation artificial joint prosthesis based on selective laser melting (selective laser melting) or selective electron beam melting (selective electron beam melting), comprising:
firstly, designing an engineer to design a prosthesis 1 and a sealing protection device 2 of a prosthesis fixing surface 4, and converting the prosthesis 1 and the sealing protection device into a digital model which can be formed by 3D printing, wherein a channel with the width of 0.5mm to 50mm is arranged between a sealing layer of the prosthesis fixing surface 4 and the prosthesis fixing surface 4, and the protection layer is provided with one or more holes with the diameter of more than 0.5mm, as shown in figure 1;
inputting the digital models of the prosthesis 1 and the protection device 2 into a selective laser melting or selective electron beam melting 3D printer, starting the printer, and molding the prosthesis 1 and the protection device 2 at one time;
then completely removing free loose metal powder inside and outside the printing piece, including powder in the space between the prosthesis fixing surface and the protection surface, wherein the metal powder is discharged from the hole 3;
then the holes 3 of the protective layer are completely sealed in vacuum by laser welding or the like to obtain a primary preformed prosthesis, as shown in figure 2;
then, carrying out primary grinding and polishing treatment on the friction surface 11 of the prosthesis 1, and cleaning the polished prosthesis 1;
then the prosthesis 1 is placed in a high-temperature oxygen-containing heat treatment furnace for surface oxidation treatment to obtain a secondary preformed prosthesis;
the seal protector of the prosthesis is then removed, as shown in figure 3;
finally, the prosthesis after removal of the protective device 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 joint prosthesis prepared by the manufacturing method, as shown in figure 3, the prosthesis 1 is provided with a prosthesis fixing surface 4 and a contact surface, the contact surface comprises an friction surface 11 or a sliding surface,
the prosthesis fixing surface 4 comprises a porous metal surface and a non-porous rough metal surface, the prosthesis fixing surface 4 is used for biological fixation with host bones,
the friction surface 11 is a zirconia or titania ceramic surface obtained by subjecting a base metal of the prosthesis 1 to surface oxidation treatment, and the friction surface 11 or sliding surface has a sliding action;
the prosthesis fixing surface 4 and the prosthesis base body 1 are integrally formed, the protection device 2 capable of preventing oxidizing gas from permeating into the prosthesis fixing surface 4 is printed around the prosthesis fixing surface 4 in the forming process, after high-temperature oxidation treatment, the protection device 2 is separated from the prosthesis 1 through machining, and the prosthesis fixing surface 4 keeps the chemical properties of base metal;
the base metal material of the prosthesis 1 comprises one or more of zirconium niobium alloy, titanium and titanium alloy.
The base material of the prosthesis prepared by the invention is zirconium-niobium alloy, titanium or titanium alloy, the prosthesis comprises a porous metal surface or a non-porous rough metal surface for biological fixation with host bones and an abrasive surface for playing a sliding role, the abrasive surface is zirconia or titania ceramics generated by carrying out high-temperature oxidation treatment on the base metal surface, the biological fixation surface of the prosthesis is formed with the prosthesis base body by an additive manufacturing method or a 3D printing method, a protective device capable of preventing oxidizing gas from permeating into the biological fixation surface is printed at the periphery of the biological fixation surface simultaneously in the forming process, after the high-temperature oxidation treatment, the protective device is separated from the prosthesis by machining, and the chemical properties of the base metal are reserved on the biological fixation surface of the prosthesis.
Further, the application range of the artificial joint prosthesis comprises: a cuboid condyle and a tibial plateau for biological fixation of a knee joint, an acetabular cup for biological fixation of a hip joint, and a ball head for resurfacing a hip joint. The prosthesis has the advantages of wear resistance and corrosion resistance of the ceramic friction surface, and the performance of the biological fixing surface which retains the chemical properties of the matrix metal and can promote bone growth.
Example 2:
referring to fig. 1-3, the present invention provides a method for manufacturing a bio-fixation artificial joint prosthesis based on a metal powder-spreading and selective binder deposition (single jet sintering) blank molding and sintering post-molding method, comprising:
firstly, designing an engineer to design a prosthesis 1 and a sealing protection device 2 of a prosthesis fixing surface 4, and converting the prosthesis 1 and the sealing protection device into a digital model which can be formed by 3D printing, wherein a space with the width of 0.5mm to 50mm is arranged between a sealing layer of the prosthesis fixing surface 4 and the prosthesis 1, and one or more holes 3 with the diameter not less than 0.5mm are arranged on a protection layer, as shown in figure 1;
inputting the digital models of the prosthesis 1 and the protection device 2 into a blank molding printer (such as a Desktop Metal "Single Jet paging Deposition" Production System) respectively filled with Metal powder and a binder, starting the printer, and molding the blanks of the prosthesis and the protection device at one time;
removing residual powder inside and outside the blank, particularly residual powder in the space between the prosthesis 1 and the protective layer, and discharging the powder from the holes 3;
removing the binder in the blank body through a relevant solvent, and then drying, wherein the binder is evaporated and discharged from the holes 3;
then placing the blank in a vacuum furnace for sintering and molding;
then all the holes 3 of the protective layer are sealed in vacuum by laser welding or the like to obtain a primary preformed prosthesis, as shown in figure 2;
then, the friction surface 11 of the prosthesis 1 is subjected to primary grinding and polishing treatment and is cleaned;
then the prosthesis is placed in a high-temperature oxygen-containing heat treatment furnace for surface oxidation treatment to obtain a secondary preformed prosthesis;
the seal protection 2 of the prosthesis 1 is then removed, as shown in figure 3;
finally, the prosthesis 1 with the protective means 2 removed is subjected to the necessary post-treatments, such as polishing, washing, etc., obtaining a fully formed prosthesis.
In one embodiment, vacuum and/or electrostatic adsorption can be used to physically remove free loose metal dust and dust particles that are attached to the green body and that are trapped between the fixed surface of the prosthesis and the protective layer.
In one embodiment, the binder on the surface of the green body can be removed by a chemical solvent through the principle of similar solubility.
The invention also provides a biological fixation artificial joint prosthesis prepared by the manufacturing method, as shown in figure 3, the prosthesis 1 is provided with a prosthesis fixing surface 4 and a contact surface, the contact surface comprises an friction surface 11 or a sliding surface,
the prosthesis fixing surface comprises a porous metal surface and a non-porous rough metal surface, the prosthesis fixing surface 4 is used for biological fixation with host bones,
the friction surface 11 is a zirconia or titania ceramic surface obtained by subjecting a base metal of the prosthesis 1 to surface oxidation treatment, and the friction surface 11 or sliding surface has a sliding action;
the prosthesis fixing surface 4 and the prosthesis base body 1 are integrally formed, the protection device 2 capable of preventing oxidizing gas from permeating into the prosthesis fixing surface 4 is printed at the periphery of the prosthesis fixing surface in the forming process, after high-temperature oxidation treatment, the protection device 2 is separated from the prosthesis 1 through machining, and the prosthesis fixing surface 4 keeps the chemical properties of base metal;
the base metal material of the prosthesis 1 comprises one or more of zirconium niobium alloy, titanium and titanium alloy.
The base material of the prosthesis prepared by the invention is zirconium-niobium alloy, titanium or titanium alloy, the prosthesis comprises a porous metal surface or a non-porous rough metal surface for biological fixation with host bones and an abrasive surface for playing a sliding role, the abrasive surface is zirconia or titania ceramics generated by carrying out high-temperature oxidation treatment on the base metal surface, the biological fixation surface of the prosthesis is formed with the prosthesis base body by an additive manufacturing method or a 3D printing method, a protective device capable of preventing oxidizing gas from permeating into the biological fixation surface is printed at the periphery of the biological fixation surface simultaneously in the forming process, after the high-temperature oxidation treatment, the protective device is separated from the prosthesis by machining, and the chemical properties of the base metal are reserved on the biological fixation surface of the prosthesis.
Further, the application range of the artificial joint prosthesis comprises: a cuboid condyle and a tibial plateau for biological fixation of a knee joint, an acetabular cup for biological fixation of a hip joint, and a ball head for resurfacing a hip joint. The prosthesis has the advantages of wear resistance and corrosion resistance of the ceramic friction surface, and the performance of the biological fixing surface which retains the chemical properties of the matrix metal and can promote bone growth.
Example 3:
referring to fig. 4-5, the present invention provides a method for manufacturing a bio-fixation artificial joint prosthesis based on a combined metal deposition (binder metal deposition) blank molding and sintering molding method, comprising:
firstly, a design engineer designs a prosthesis 1 and a protection device 2 of a prosthesis fixing surface 4, then the design is converted into a digital model which can be formed by digital 3D printing, an Anti-sintering isolation layer 5(Anti-sintering agent) which can prevent the reaction (sintering) between the prosthesis fixing surface 4 and the protection device 2 in a high-temperature environment is arranged between the designed prosthesis biological fixing surface 4 and the protection device 2, and the Anti-sintering isolation layer 5 is generally a ceramic material resisting the high-temperature reaction, as shown in figure 4;
inputting the digital models of the prosthesis 1 and the protection device 2 into a special blank forming 3D printer with double nozzles, such as a student System or a Markformed Metal X System of a Desktop Metal, wherein the printer generally comprises two different raw material boxes and corresponding nozzles, the first raw material box is filled with a mixture of Metal powder and a binder which are mixed in proportion, and the second raw material box is filled with a sintering-proof ceramic material; starting a printer, and forming blanks of the prosthesis 1 and the protection device 2 at one time;
removing the adhesive in the blank body through a relevant solvent, drying, and evaporating and discharging the adhesive from the holes 3;
then placing the blank body into a high-temperature vacuum furnace, and sintering and molding at a temperature slightly lower than the melting point of the prosthesis metal material;
then the friction surface 11 of the sintered prosthesis 1 is subjected to necessary grinding and polishing treatment;
placing the sintered part processed in the step S5 into a heat treatment furnace, and carrying out surface oxidation treatment in a high-temperature oxygen-containing environment; because of the existence of the compact peripheral protective layer, the prosthesis fixing surface 4 of the prosthesis 1 is isolated from oxygen or active gas, so that no chemical reaction exists, and because of the existence of the anti-sintering isolation layer 5, sintering cannot be generated between the prosthesis fixing surface 4 of the prosthesis and the protective layer again, so that the prosthesis fixing surface can be separated after heat treatment without changing the chemical and physical properties of the fixing surface;
the peripheral sealing layer of the protector 2 is then removed by machining, such as wire cutting, and the protector 2, after peripheral cutting, will be easily separated from the prosthesis itself, as shown in figure 5, due to the presence of the anti-sintering barrier layer 5 between the prosthesis anchoring face 4 and the protective layer of the prosthesis.
Finally, the prosthesis 1 with the protective device 2 removed is subjected to the necessary post-treatments, such as polishing, washing, etc., obtaining a shaped prosthesis.
In one embodiment, vacuum and/or electrostatic adsorption is used to physically remove free loose metal dust and dust particles that are attached to the green body and are trapped between the fixed surface of the prosthesis and the protective layer.
In one embodiment, the binder on the surface of the green body is removed by a chemical solvent through the principle of similar compatibility.
The molding method of the artificial joint prosthesis and the fixing surface anti-oxidation protection device comprises the steps of extruding a mixture of metal powder and a binder through a nozzle to print a blank layer by layer, and adding a layer of high-temperature sintering-resistant ceramic powder between the biological fixing surface of the prosthesis and the anti-oxidation protection device to realize that the biological fixing surface keeps the chemical properties of matrix metal and the original geometric morphology of a bone fixing surface in subsequent sintering and high-temperature oxidation processes.
The invention also provides a biological fixation artificial joint prosthesis prepared by the manufacturing method, as shown in figure 3, the prosthesis 1 is provided with a prosthesis fixing surface 4 and a contact surface, the contact surface comprises an friction surface 11 or a sliding surface,
the prosthesis fixing surface 4 comprises a porous metal surface and a non-porous rough metal surface, the prosthesis fixing surface 4 is used for biological fixation with host bones,
the friction surface 11 is a zirconia or titania ceramic surface obtained by subjecting a base metal of the prosthesis 1 to surface oxidation treatment, and the friction surface 11 or sliding surface has a sliding action;
the prosthesis fixing surface 4 and the prosthesis base body 1 are integrally formed, the protection device 2 capable of preventing oxidizing gas from permeating into the prosthesis fixing surface 4 is printed around the prosthesis fixing surface 4 in the forming process, after high-temperature oxidation treatment, the protection device 2 is separated from the prosthesis 1 through machining, and the prosthesis fixing surface 4 keeps the chemical properties of base metal;
the base metal material of the prosthesis 1 comprises one or more of zirconium niobium alloy, titanium and titanium alloy.
The base material of the prosthesis prepared by the invention is zirconium-niobium alloy, titanium or titanium alloy, the prosthesis comprises a porous metal surface or a non-porous rough metal surface for biological fixation with host bones and an abrasive surface for playing a sliding role, the abrasive surface is zirconia or titania ceramics generated by carrying out high-temperature oxidation treatment on the base metal surface, the biological fixation surface of the prosthesis is formed with the prosthesis base body by an additive manufacturing method or a 3D printing method, a protective device capable of preventing oxidizing gas from permeating into the biological fixation surface is printed at the periphery of the biological fixation surface simultaneously in the forming process, after the high-temperature oxidation treatment, the protective device is separated from the prosthesis by machining, and the chemical properties of the base metal are reserved on the biological fixation surface of the prosthesis.
Further, the application range of the artificial joint prosthesis comprises: a cuboid condyle and a tibial plateau for biological fixation of a knee joint, an acetabular cup for biological fixation of a hip joint, and a ball head for resurfacing a hip joint. The prosthesis has the advantages of wear resistance and corrosion resistance of the ceramic friction surface, and the performance of the biological fixing surface which retains the chemical properties of the matrix metal and can promote bone growth.
With reference to the embodiments 1 to 3, the bio-fixation artificial joint prosthesis and the manufacturing method and application thereof provided by the invention really solve the problems in the prior art, and provide a prosthesis which has better performance and better meets the requirements of human environment in the medical field.
The prosthesis fixing surface which does not need surface oxidation treatment is isolated and protected by the protection device, so that the base metal of the prosthesis does not reach the prosthesis fixing surface when the surface oxidation treatment is carried out, and the strength and the toughness of the material at the prosthesis fixing surface are ensured;
compared with the prosthesis prepared by the prior art, the prosthesis prepared by the preparation method has a ceramic friction surface and a porous surface with the characteristics of original metal, solves the problems that the metal surface of a base body is completely oxidized and ceramic is generated by improving the processing mode, and the strength and the toughness of the prosthesis base body are seriously influenced by the ceramic porous structure;
the prosthesis prepared by the preparation method of the invention comprises 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, and the biological fixing surface of the prosthesis is a rough or porous structure which keeps chemical components of base body metal, so that different parts of the prosthesis have different physical 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;
the principle of the manufacturing method is that the part of the prosthesis which does not need surface oxidation is isolated by the protection device, and in the manufacturing process, the protection device and the prosthesis are integrally formed, so that the sealing performance is better, the isolation effect is better, and only the part of the base metal of the prosthesis exposed outside the protection device is ensured to be oxidized;
in the manufacturing method, because the prosthesis protection device is used, the prosthesis fixing surface is isolated from oxygen or active gas, so that no chemical reaction exists, and sintering cannot be generated between the biological fixing surface and the protection layer of the prosthesis again due to the existence of the sintering-resistant ceramic layer, so that the biological fixing surface and the protection layer can be separated after heat treatment without changing the chemical and physical properties of the fixing surface;
in the manufacturing method of the invention, the prosthesis protection device can be removed from the prosthesis by machining, for example, a peripheral sealing layer of the prosthesis protection device is removed by linear cutting, and the protection device after peripheral cutting is easily separated from the prosthesis due to the anti-sintering isolation layer between the biological fixing surface and the protection layer of the prosthesis;
the prosthesis prepared by the preparation method of the invention is a prosthesis with both friction surface function and bone fixing surface function, including but not limited to artificial knee joint cuboid condyle, artificial knee joint tibial platform with double sliding design, artificial hip joint acetabular cup with double sliding design, hip joint cuboid bulb for surface replacement, etc.; the prosthesis has the performances of wear resistance and corrosion resistance of a ceramic friction surface, and also retains the performance of a biological fixing surface with the chemical characteristics of a base metal for promoting bone growth or bone ingrowth;
the forming method of the prosthesis and the protection device can realize that the biological matrix and the fixed surface keep the physical and chemical properties of matrix metal and the original geometric appearance of the bone fixed surface in the subsequent sintering and high-temperature oxidation processes, 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;
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 (10)
1. A method for manufacturing a biological fixation artificial joint prosthesis is characterized by comprising the following steps:
s1: designing a prosthesis (1) with a protection device (2) through three-dimensional software to obtain a digital prosthesis model;
s2: integrally printing and molding the digital prosthesis model obtained in the step S1 by using a 3D printer to obtain a prosthesis blank, wherein the prosthesis blank is provided with a fixing surface (4) and a friction surface (11);
s3: cleaning residual impurities of the prosthesis blank obtained in the step S2, drying, sintering, and sealing a fixing surface (4) on the sintered prosthesis blank under a vacuum condition to obtain a primary preformed prosthesis;
s4: grinding, polishing and cleaning the friction surface (11) of the primary preformed prosthesis obtained in the step S3, and then putting the friction surface into a heat treatment furnace for surface oxidation treatment to obtain a secondary preformed prosthesis;
s5: and removing the protective device (2) on the secondary preformed prosthesis obtained in the step S4 to obtain the molded prosthesis (1).
2. The method of manufacturing according to claim 1, wherein in step S2, the prosthesis blank further has a prosthesis fixation surface (4),
a sealing protection device is arranged on the prosthesis fixing surface (4), one or more holes (3) are formed in the protection device, and the diameter of each hole (3) is larger than 0.5 mm; a channel is arranged between the protection device and the prosthesis fixing surface (4), and the width range of the channel is 0.5 mm-50 mm;
the prosthesis blank is formed by laying prosthesis base metal powder and selective caking agent layer by layer and depositing.
3. The method according to claim 1, wherein the prosthesis blank further comprises an anti-sintering isolation layer (5) in step S2,
the sintering-prevention isolation layer (5) is arranged between the prosthesis fixing surface (4) and the protection device (2), and the sintering-prevention isolation layer (5) comprises a high-temperature-resistant ceramic material.
4. The manufacturing method according to claim 1, wherein in step S2, the 3D printer includes: the device comprises a selective area laser melting 3D printer, a selective area electron beam melting 3D printer, a blank forming printer and a blank forming 3D printer, wherein the blank forming printer is respectively filled with metal powder and a binder;
one of the double spray heads sprays mixture, and the other of the double spray heads sprays anti-sintering ceramic material;
the mixture comprises a mixture of metal powder and a binder mixed according to a certain proportion.
5. The method for manufacturing a prosthesis according to claim 1, wherein in step S3, the residual impurities include free loose metal dust attached to the body, dust particles interposed between the prosthesis fixing surface (4) and the protective layer, and a binder on the surface of the prosthesis body;
and (3) placing the prosthesis blank in a vacuum furnace, sintering and molding, and sealing the hole (3) on the prosthesis blank protective layer in vacuum.
6. The method of manufacture according to claim 5, characterized in that the free loose metal dust adhering to the green body and the dust particles between the prosthesis anchoring face (4) and the protective layer are removed by physical means using vacuum and/or electrostatic adsorption;
removing the binder on the surface of the prosthesis blank by using a chemical solvent according to the principle of similarity and compatibility;
the sintering temperature of the prosthesis blank in a vacuum furnace is lower than the melting point of the metal material;
and the holes on the protective layer of the prosthesis blank body are sealed by laser welding.
7. The method of claim 1, wherein in step S4, the primary preform prosthesis is subjected to a surface oxidation treatment in a high temperature oxygen-containing heat treatment furnace.
8. Method of manufacturing according to claim 1, characterized in that in step S5, the secondary preformed prosthesis is machined to remove the protection device (2).
9. The bio-immobilized artificial joint prosthesis produced by the production method according to any one of claims 1 to 8, wherein the prosthesis (1) has a fixation surface (4) and a contact surface comprising an abrasion surface (11) or a sliding surface,
the prosthesis fixing surface (4) comprises a porous metal surface and a non-porous rough metal surface,
the friction surface (11) is a zirconia or titania ceramic surface obtained by performing surface oxidation treatment on a base metal of the prosthesis (1);
the prosthesis fixing surface (4) and the prosthesis (1) base body are integrally formed;
the base metal material of the prosthesis (1) comprises one or more of zirconium niobium alloy, titanium and titanium alloy.
10. Use of the bio-fixation artificial joint prosthesis according to claim 9, wherein the artificial joint prosthesis is applied to the cuboid condyle and tibial plateau of a bio-fixation knee joint, the acetabular cup of a bio-fixation hip joint, and the ball head of a resurfacing hip joint.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202410569523.1A CN118476905A (en) | 2020-04-28 | 2020-04-28 | Biological fixed artificial joint prosthesis |
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| US5861042A (en) * | 1990-09-17 | 1999-01-19 | Buechel; Frederick F. | Prosthesis with biologically inert wear resistant surface |
| EP1358859A1 (en) * | 2002-04-29 | 2003-11-05 | Politecnico Di Milano | Bone prostheses having multilayer interface |
| KR20130038701A (en) * | 2011-10-10 | 2013-04-18 | 주식회사 제노스 | Method for producing porous bioceramics using vacuum-assisted foaming technique and porous bioceramics manufactured thereby |
| CN103732185A (en) * | 2011-06-15 | 2014-04-16 | 德里克·詹姆斯·华莱士·麦克明 | Method of forming polymeric component |
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| CN109009571A (en) * | 2018-08-02 | 2018-12-18 | 北京积水潭医院 | A kind of wear-resisting joint prosthesis part replacement prosthesis and its application method |
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2020
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| US5861042A (en) * | 1990-09-17 | 1999-01-19 | Buechel; Frederick F. | Prosthesis with biologically inert wear resistant surface |
| EP1358859A1 (en) * | 2002-04-29 | 2003-11-05 | Politecnico Di Milano | Bone prostheses having multilayer interface |
| CN103732185A (en) * | 2011-06-15 | 2014-04-16 | 德里克·詹姆斯·华莱士·麦克明 | Method of forming polymeric component |
| KR20130038701A (en) * | 2011-10-10 | 2013-04-18 | 주식회사 제노스 | Method for producing porous bioceramics using vacuum-assisted foaming technique and porous bioceramics manufactured thereby |
| CN104840273A (en) * | 2015-05-21 | 2015-08-19 | 北京爱康宜诚医疗器材股份有限公司 | Prosthesis component and method for manufacturing same |
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