CN113558829B - Biological fixed artificial joint prosthesis and manufacturing method and application thereof - Google Patents
Biological fixed artificial joint prosthesis and manufacturing method and application thereof Download PDFInfo
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- CN113558829B CN113558829B CN202010350825.1A CN202010350825A CN113558829B CN 113558829 B CN113558829 B CN 113558829B CN 202010350825 A CN202010350825 A CN 202010350825A CN 113558829 B CN113558829 B CN 113558829B
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- 238000005245 sintering Methods 0.000 claims abstract description 37
- 238000011282 treatment Methods 0.000 claims abstract description 37
- 238000010438 heat treatment Methods 0.000 claims abstract description 23
- 238000010301 surface-oxidation reaction Methods 0.000 claims abstract description 20
- 238000007789 sealing Methods 0.000 claims abstract description 19
- 230000001681 protective effect Effects 0.000 claims abstract description 16
- 238000004140 cleaning Methods 0.000 claims abstract description 12
- 238000005498 polishing Methods 0.000 claims abstract description 11
- 238000000227 grinding Methods 0.000 claims abstract description 6
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- 238000001035 drying Methods 0.000 claims abstract description 5
- 239000012535 impurity Substances 0.000 claims abstract description 5
- 229910052751 metal Inorganic materials 0.000 claims description 61
- 239000002184 metal Substances 0.000 claims description 61
- 238000000034 method Methods 0.000 claims description 46
- 239000010410 layer Substances 0.000 claims description 37
- 239000000919 ceramic Substances 0.000 claims description 33
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- 239000000126 substance Substances 0.000 claims description 24
- 239000000843 powder Substances 0.000 claims description 22
- 229910001257 Nb alloy Inorganic materials 0.000 claims description 20
- MCMNRKCIXSYSNV-UHFFFAOYSA-N Zirconium dioxide Chemical compound O=[Zr]=O MCMNRKCIXSYSNV-UHFFFAOYSA-N 0.000 claims description 20
- GFUGMBIZUXZOAF-UHFFFAOYSA-N niobium zirconium Chemical compound [Zr].[Nb] GFUGMBIZUXZOAF-UHFFFAOYSA-N 0.000 claims description 20
- 239000011230 binding agent Substances 0.000 claims description 18
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- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 claims description 14
- 239000010936 titanium Substances 0.000 claims description 14
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 claims description 13
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- 238000002844 melting Methods 0.000 claims description 13
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- 238000002955 isolation Methods 0.000 claims description 10
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- 229910001275 Niobium-titanium Inorganic materials 0.000 claims description 9
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- GUVRBAGPIYLISA-UHFFFAOYSA-N tantalum atom Chemical compound [Ta] GUVRBAGPIYLISA-UHFFFAOYSA-N 0.000 description 3
- OGIDPMRJRNCKJF-UHFFFAOYSA-N titanium oxide Inorganic materials [Ti]=O OGIDPMRJRNCKJF-UHFFFAOYSA-N 0.000 description 3
- 239000012298 atmosphere Substances 0.000 description 2
- 230000002599 biostatic effect Effects 0.000 description 2
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- 238000013150 knee replacement Methods 0.000 description 2
- 230000007774 longterm Effects 0.000 description 2
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- 238000012545 processing Methods 0.000 description 2
- 229910052715 tantalum Inorganic materials 0.000 description 2
- 239000004699 Ultra-high molecular weight polyethylene Substances 0.000 description 1
- QCWXUUIWCKQGHC-UHFFFAOYSA-N Zirconium Chemical compound [Zr] QCWXUUIWCKQGHC-UHFFFAOYSA-N 0.000 description 1
- 238000005299 abrasion Methods 0.000 description 1
- 239000012790 adhesive layer Substances 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 238000005524 ceramic coating Methods 0.000 description 1
- 238000003279 ceramming Methods 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 229910001429 cobalt ion Inorganic materials 0.000 description 1
- XLJKHNWPARRRJB-UHFFFAOYSA-N cobalt(2+) Chemical compound [Co+2] XLJKHNWPARRRJB-UHFFFAOYSA-N 0.000 description 1
- 238000012938 design process Methods 0.000 description 1
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- 229910052588 hydroxylapatite Inorganic materials 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
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- 230000000399 orthopedic effect Effects 0.000 description 1
- XYJRXVWERLGGKC-UHFFFAOYSA-D pentacalcium;hydroxide;triphosphate Chemical compound [OH-].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O XYJRXVWERLGGKC-UHFFFAOYSA-D 0.000 description 1
- 238000000053 physical method Methods 0.000 description 1
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- 238000004901 spalling Methods 0.000 description 1
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- 231100000419 toxicity Toxicity 0.000 description 1
- 230000007704 transition Effects 0.000 description 1
- 229920000785 ultra high molecular weight polyethylene Polymers 0.000 description 1
- 229910052726 zirconium Inorganic materials 0.000 description 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
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- A—HUMAN NECESSITIES
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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
- A61F2/30—Joints
- A61F2/3094—Designing or manufacturing processes
- A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
- A61F2002/30772—Apertures or holes, e.g. of circular cross section
- A61F2002/30784—Plurality of holes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/3094—Designing or manufacturing processes
- A61F2002/30968—Sintering
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61F2/02—Prostheses implantable into the body
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- A61F2002/3097—Designing or manufacturing processes using laser
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/3094—Designing or manufacturing processes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00011—Metals or alloys
- A61F2310/00023—Titanium or titanium-based alloys, e.g. Ti-Ni alloys
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00011—Metals or alloys
- A61F2310/00035—Other metals or alloys
- A61F2310/00089—Zirconium or Zr-based alloys
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00011—Metals or alloys
- A61F2310/00035—Other metals or alloys
- A61F2310/00095—Niobium or Nb-based alloys
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- 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
- A61F2310/00616—Coating made of titanium oxide or hydroxides
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- 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
- A61F2310/00634—Coating made of zirconium oxide or hydroxides
Landscapes
- 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 fixed artificial joint prosthesis and a manufacturing method and application thereof, comprising the following steps: the prosthesis and the protection device are integrally designed through three-dimensional software, and a digital model of the prosthesis and the protection device is obtained; printing and forming 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 forming the blank, and vacuum sealing holes on the prosthesis to obtain a preliminarily formed prosthesis; grinding, polishing and cleaning the friction surface of the preliminarily molded prosthesis, and then placing the friction surface into a heat treatment furnace for surface oxidation treatment to obtain a basically molded prosthesis; removing the protective device on the basically formed prosthesis to obtain a fully formed prosthesis, and carrying out post-treatment on the fully formed 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 fixed 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: ① Fixation between the prosthesis and the host bone and long term stability; ② Wear resistance of the joint sliding surface and biocompatibility of abrasive dust. Thus, over the past twenty years, the history of prosthetic joint materials and prosthetic joint designs have been essentially expanding around the two factors.
Today, biological fixation techniques represented by porous metals and friction pair techniques represented by ceramics to high cross-linked ultra-high molecular weight polyethylene have become recognized "gold standards" in the field of global artificial joints, and the bone fixation surfaces of modern artificial joints are also basically coated with titanium, titanium alloys, tantalum or hydroxyapatite.
The bone fixation surface of the traditional artificial joint is a cobalt-based alloy, but the biocompatibility between the traditional artificial joint and host bone is obviously inferior to that of metals such as titanium, tantalum and the like, and the traditional artificial joint has basically exited from the material selection of the biological fixation surface of the modern joint.
However, if the cobalt-based alloy is used as the friction surface, the wear resistance of the cobalt-based alloy is far better than that of titanium, tantalum metal and alloy, so that the cobalt-based alloy is basically limited to the friction surface in the application of modern artificial joints, or prostheses mainly fixed by bone cement, such as hip joint ball heads, knee joint cuboid condyles, tibia platforms and the like.
In recent years, cobalt-based alloy bulbs have been increasingly replaced by ceramic bulbs or surface-ceramic zirconium-niobium alloy bulbs in developed countries such as europe and america, because of the wide attention of orthopedics in reporting the toxicity of the products of corrosion or abrasion (cobalt ions, particulates) to host bones and soft tissues.
However, since ceramic-based prostheses are far less impact resistant than metallic materials, applications of extremely high-stress environment-demanding knee replacements remain extremely rare, and surface-ceramic zirconium-niobium alloys (Oxidized Zirconium) have gained popularity in clinical applications over the past twenty years.
The main reasons that surface-ceramic zirconium niobium alloy prostheses have gained acceptance by clinicians are their wear, corrosion, impact fracture resistance, and the non-spalling nature. The main factors that confer these characteristics are due to their unique technical processes: firstly, the surface 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 zone which is naturally formed in the heat treatment process is arranged between the zirconia surface and the matrix, so that no obvious interface exists between the ceramic surface and the matrix.
In recent years, titanium-based alloys have also received attention through heat treatment techniques similar to the surface ceramming of zirconium-niobium alloys. Because the titanium alloy is the most commonly used material for the artificial joint and the price is far lower than that of the zirconium-niobium alloy, the heat treatment technology based on the surface ceramic principle of the zirconium-niobium alloy or the titanium alloy has more general application value.
However, the heat treatment process for ceramic treatment of the metal surface of the titanium-based alloy or the zirconium-niobium alloy has the following characteristics: ① The base metal must be heat treated at high temperature (above 500 degrees celsius) in an atmosphere containing an oxidizing gas; ② All of the base metal is heat treated and oxidation inevitably occurs on all surfaces of the prosthesis, including the friction surface and the fixation surface.
For bio-immobilized prostheses, particularly prostheses containing a porous metal anchoring surface, after heat treatment, the porous metal surface will be oxidized and ceramified, and the ceramified porous structure will severely affect the strength and toughness. If porous metal fixation surfaces are bonded to the heat treated prosthesis by high temperature sintering or the like, the ceramified 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 surface-ceramic zirconium-niobium alloy prostheses have been subjected to over twenty years of clinical practice, only one form of bone cement fixation in knee replacement, a non-bone cement biosolidation form has not been achieved yet, and further, in the state of the art, the problem of preventing oxidation of the zirconium-niobium alloy or titanium alloy porous surface during high temperature heat treatment remains.
Therefore, a new solution is needed to solve the above problems, so as to realize a porous surface with both a ceramic friction surface and original metal characteristics of zirconium-niobium alloy or titanium alloy.
Disclosure of Invention
The invention aims to solve the problems in the prior art and provides a manufacturing method of a biological fixed artificial joint prosthesis, which adopts the following technical scheme:
A method for manufacturing a biological fixed artificial joint prosthesis, comprising the following steps:
S1: designing a prosthesis with a protection device through three-dimensional software to obtain a digital prosthesis model;
S2: printing and molding the digital prosthesis model obtained in the step S1 into a whole 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 holes of a protection device on the sintered prosthesis blank under a vacuum condition to obtain a one-time 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 (3) removing the protective device on the secondary preformed prosthesis obtained in the step S4 to obtain the formed prosthesis.
In the above technical solution, in step S2, the prosthesis blank has a prosthesis fixing surface,
Further, 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 0.5mm; 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 paving prosthesis matrix metal powder and depositing a selective adhesive layer by layer;
further, in step S2, the prosthesis blank further includes an anti-sintering isolation layer;
further, the anti-sintering isolation layer is arranged between the prosthesis fixing surface and the protection device, and comprises a ceramic material resistant to high-temperature reaction;
further, in step S2, the 3D printer includes: a 3D printer for selective laser melting, a 3D printer for selective electron beam melting, a green body forming printer respectively filled with metal powder and binder, and a green body forming 3D printer with double spray heads;
further, one of the dual spray nozzles sprays a mixture, and the other of the dual spray nozzles sprays a sintering-preventing ceramic material;
Further, the mixture includes a mixture of metal powder and a binder mixed in a certain ratio.
Further, in step S3, the residual impurities include free loose metal dust attached to the blank, dust particles between the prosthesis fixation surface and the protective layer, and a binder on the surface of the blank;
Further, placing the blank in a vacuum furnace for sintering and molding, and sealing holes on a blank protective layer under vacuum;
Further, removing free loose metal dust and dust particles between the prosthesis fixation surface and the protective layer attached to the blank by a physical method through vacuum and/or electrostatic adsorption;
Further, removing the binder on the surface of the blank body by using a chemical solvent according to a similar compatibility principle;
further, the sintering temperature of the blank in a vacuum furnace is lower than the melting point of the metal material;
further, the holes on the blank protection layer are sealed through laser welding.
Further, in step S4, the primary preform prosthesis is subjected to 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 fixed artificial joint prosthesis prepared by the technical scheme, which is provided with a prosthesis fixing surface and a contact surface, wherein the contact surface comprises a friction surface or a sliding surface,
Further, the prosthesis fixation surface comprises a porous metal surface and a non-porous roughened metal surface;
further, the friction surface is a zirconia or titania ceramic surface obtained by performing surface oxidation treatment on the base metal of the prosthesis;
Further, the prosthesis fixation surface and the prosthesis base body are integrally formed;
Further, the base metal material of the prosthesis comprises one or more of zirconium niobium alloy, titanium and titanium alloy.
The invention also provides application of the biological fixed artificial joint prosthesis, wherein the artificial joint prosthesis is applied to a cuboid condyle and a tibia platform of a biological fixed knee joint, an acetabular cup of the biological fixed hip joint and a ball head of a surface replacement hip joint.
Compared with the prior art, the invention has one or more of the following beneficial effects:
1. The invention uses the protection device to isolate and protect the fixing surface of the prosthesis without surface oxidation treatment, so that the base metal of the prosthesis does not reach the fixing surface of the prosthesis when the surface oxidation treatment is carried out, and the strength and toughness of the material at the fixing surface of the prosthesis are ensured;
2. Compared with the prosthesis prepared by the prior art, the prosthesis prepared by the preparation method solves the problem that the metal surface of the matrix is completely oxidized and ceramic by improving the processing mode, and the ceramic porous structure seriously influences the strength and toughness of the matrix of the prosthesis;
3. The prosthesis prepared by the preparation method comprises a friction surface or a sliding surface and a biological fixation surface with rough or porous surface; the friction surface of the prosthesis is oxide which is similar to ceramic performance and directly grows from a matrix through high-temperature oxidation heat treatment, and the biological fixing surface of the prosthesis is a rough or porous structure which keeps the chemical components of the matrix metal, so that different parts of the prosthesis have different physical properties, the service performance is improved, and the prosthesis is purposefully modified to meet the requirements of human environment in the process of being used;
4. the principle of the manufacturing method is that the protecting device is used for isolating the part of the prosthesis which does not need surface oxidation, and in the manufacturing process, the protecting device and the prosthesis are integrally formed, so that the sealing performance is better, the isolating effect is better, and only the part of the matrix metal of the prosthesis exposed outside the protecting device is oxidized;
5. In the manufacturing method, because the prosthesis protection device is used, the fixing surface of the prosthesis is isolated from oxygen or active gas, no chemical reaction exists, and the sintering cannot be generated again between the biological fixing surface of the prosthesis and the protection layer due to the existence of the sintering-resistant ceramic layer, so that the prosthesis can be separated after heat treatment without changing the chemical and physical properties of the fixing surface;
6. The prosthesis protection device in the manufacturing method can be removed from the prosthesis by machining, for example, a peripheral sealing layer of the prosthesis protection device is removed by wire cutting, and the protection device after peripheral cutting is easily separated from the prosthesis due to a channel with a certain width or a sintering-preventing isolation layer between a biological fixing surface of the prosthesis and the protection layer;
7. The prosthesis prepared by the preparation method is a prosthesis with the functions of a friction surface and a bionic fixing surface, and comprises but is not limited to artificial knee joint cuboid condyles, artificial knee joint tibia platforms with double sliding designs, artificial hip joint acetabular cups with double sliding designs, hip joint cuboid ball heads for surface replacement and the like; the prosthesis has the wear-resistant and corrosion-resistant performances of the ceramic friction surface, and also retains the performances of promoting bone growth or bone ingrowth of the biological fixing surface with the chemical characteristics of the matrix metal;
8. The forming method of the prosthesis and the protecting device comprises the following steps: selecting a zone laser melting 3D printing method; selecting an electron beam melting 3D printing method; a method of forming a green body by laying powder layer by layer (matrix metal powder of the prosthesis) and adding a selective adhesive for deposition, and then finally forming by high-temperature vacuum sintering; a method of extruding a mixture of metal powder and a binder through a nozzle to print out a green body layer by layer, and adding a layer of ceramic powder for preventing high-temperature sintering between a biological fixation surface of the prosthesis and an oxidation-preventing protection device;
9. The forming method of the prosthesis and the protecting device can realize that the physical and chemical characteristics of the matrix metal and the original geometric morphology of the bionic fixing surface of the biological matrix and the fixing surface can be maintained in the subsequent sintering and high-temperature oxidation processes, and the manufactured prosthesis is more suitable for human environment and has more practicability;
10. The manufacturing method is primarily realized by using computer software and a 3D printer, is easy to realize in terms of the speed of technological development at present, and is more convenient to realize along with the progress of the technology, so that the manufacturing method is connected with the era, the technology is promoted to progress, the technological development is promoted to progress, and a virtuous circle is formed.
Drawings
In order to more clearly illustrate the embodiments of the invention or the technical solutions in the prior art, the drawings that are required in the embodiments or the description of the prior art will be briefly described, it being obvious that the drawings in the following description are only some embodiments of the invention, and that other drawings may be obtained from these drawings without inventive effort for a person skilled in the art.
FIG. 1 is a schematic view of the overall structure of a prosthesis and a protection device according to an embodiment of the present invention;
FIG. 2 is a schematic view of the entire structure of the prosthesis and protection device of FIG. 1 after the hole is sealed;
FIG. 3 is a schematic view of the structure of the prosthesis after it has been fully formed in accordance with an embodiment of the present invention;
FIG. 4 is a schematic view showing the overall structure of a prosthesis and a protector having an anti-sintering separator according to embodiment 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-protection device, 3-hole, 4-prosthesis fixing surface, 5-anti-sintering isolation layer.
Detailed Description
The following description of the embodiments of the present invention will be made with reference to the accompanying drawings, in which it is evident that the embodiments described are only some, but not all embodiments of the invention. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
The prosthesis prepared by the prior art is oxidized at the same time when the prosthesis is subjected to high-temperature surface oxidation treatment, so that the metal characteristics of the prosthesis fixing surface are affected, the strength and the toughness of the prosthesis fixing surface are affected, and the service performance is reduced, and therefore, the invention provides a novel technical scheme to solve the problems.
The principle of the method for preparing the biological fixed 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 fixing surface of the prosthesis;
secondly, integrally forming the prosthesis and the anti-oxidation protection device by a digital additive manufacturing or 3D printing method;
Thirdly, performing preliminary polishing treatment on the friction surface of the prosthesis after printing and forming;
fourthly, performing high-temperature heat treatment on the molded printing piece in an oxygen-containing gas;
Fifthly, removing the seal protection device of the printing piece after heat treatment;
Sixth, the prosthesis after removal of the protective device is subjected to necessary post-treatments such as polishing, cleaning, etc.
The base material of the prosthesis prepared by the preparation method is zirconium-niobium alloy or titanium and titanium alloy, and the prosthesis comprises a friction surface or sliding surface and a biological fixation surface with rough or porous surface. The friction surface of the prosthesis is oxide which is similar to ceramic performance and directly grows from a matrix through high-temperature oxidation heat treatment, and the biological fixation surface of the prosthesis is a rough or porous structure which maintains the chemical composition of the matrix metal.
The gist of the present invention will be further described with reference to the drawings and examples.
Example 1:
Referring to fig. 1-3, the present invention provides a method for manufacturing a biological fixation artificial joint prosthesis based on selective laser melting (SELECTIVE LASER MELTING) or selective electron beam melting (SELECTIVE ELECTRON BEAM MELTING) forming, comprising:
Firstly, a design engineer designs a sealing protection device 2 of a prosthesis 1 and a prosthesis fixing surface 4, and converts the sealing protection device into a digital model which can be formed by 3D printing, 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 one or more holes with the diameter larger than 0.5mm are arranged on the protecting layer, as shown in figure 1;
inputting the digitized 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 forming the prosthesis 1 and the protection device 2 at one time;
thoroughly removing free loose metal powder from the inside and outside of the printed part, including powder in the space between the fixing surface and the protecting surface of the prosthesis, and discharging the metal powder from the holes 3;
The holes 3 of the protective layer are completely sealed in vacuum by laser welding or an approximate method, and a one-time preformed prosthesis is obtained, as shown in figure 2;
Performing preliminary grinding and polishing treatment on the friction surface 11 of the prosthesis 1, and cleaning the polished prosthesis 1;
then placing the prosthesis 1 into 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 fig. 3;
Finally, the prosthesis after removal of the protective device is subjected to the necessary post-treatments, such as polishing, cleaning, etc., to obtain a fully formed prosthesis.
The invention also provides a biological anchoring artificial joint prosthesis produced by the above-described production method, as shown in fig. 3, the prosthesis 1 having a prosthesis anchoring face 4 and a contact face, the contact face comprising a friction face 11 or a sliding face,
The prosthetic fixation surface 4 comprises a porous metal surface and a non-porous roughened metal surface, the prosthetic fixation surface 4 is for biostatic with a host bone,
The friction surface 11 is a zirconia or titania ceramic surface obtained by surface oxidation treatment of the base metal of the prosthesis 1, and the friction surface 11 or sliding surface has a sliding function;
The prosthesis fixation surface 4 and the prosthesis base body 1 are integrally formed, and a protecting device 2 capable of preventing the oxidizing gas from penetrating into the prosthesis fixation surface 4 is printed out at the same time around the prosthesis fixation surface 4 in the forming process, after high-temperature oxidation treatment, the protecting device 2 is separated from the prosthesis 1 through machining, and the prosthesis fixation surface 4 retains the chemical characteristics of the 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 nonporous rough metal surface for biological fixation with a host bone and a friction surface for sliding, the friction surface is zirconia or titanium oxide ceramic generated by high-temperature oxidation treatment on the surface of the base metal, the biological fixation surface of the prosthesis is formed together with a prosthesis base body by an additive manufacturing or 3D printing method, a protective device capable of preventing oxidative gas from penetrating into the biological fixation surface is printed around the biological fixation surface in the forming process, and after the high-temperature oxidation treatment, the protective device is separated from the prosthesis by machining, and the biological fixation surface of the prosthesis maintains the chemical characteristics of the base metal.
Further, the application range of the artificial joint prosthesis includes: the artificial knee joint comprises a cuboid condyle and a tibial plateau which are biological fixed knee joints, an acetabular cup which is biological fixed hip joints and a ball head for surface replacement of the hip joints. The prosthesis has the advantages of wear resistance and corrosion resistance of the ceramic friction surface, and the capability of promoting bone growth or bone ingrowth of the biological fixing surface which retains the chemical characteristics of the matrix metal.
Example 2:
Referring to fig. 1-3, the present invention provides a method for manufacturing a biological anchoring artificial joint prosthesis based on a method of molding and sintering a metal powder and binder selective deposition (single jet PASSING AND deposition) blank, comprising:
Firstly, a design engineer designs a sealing protection device 2 of a prosthesis 1 and a prosthesis fixing surface 4, and converts the sealing protection device into a digital model which can be formed by 3D printing, 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 smaller than 0.5mm are arranged on the protecting layer, as shown in figure 1;
inputting the digital models of the prosthesis 1 and the protecting device 2 into a blank molding printer (such as a Desktop Metal Single Jet Passing Deposition Production System) respectively filled with Metal powder and a binder, starting the printer, and molding the blanks of the prosthesis and the protecting device at one time;
removing residual powder inside and outside the blank body, particularly the residual powder in the space between the prosthesis 1 and the protective layer, wherein the powder is discharged from the hole 3;
Removing the binder in the blank body through the relevant solvent, and drying, wherein the binder is evaporated and discharged from the holes 3;
placing the blank body in a vacuum furnace for sintering and molding;
sealing all holes 3 of the protective layer in vacuum by laser welding or an approximate method to obtain a one-time preformed prosthesis, as shown in fig. 2;
Then, carrying out preliminary grinding and polishing treatment on the friction surface 11 of the prosthesis 1, and cleaning;
then placing the prosthesis into a high-temperature oxygen-containing heat treatment furnace for surface oxidation treatment to obtain a secondary preformed prosthesis;
The seal protection device 2 of the prosthesis 1 is removed again, as shown in fig. 3;
finally, the prosthesis 1, from which the protective device 2 has been removed, is subjected to the necessary post-treatments, such as polishing, cleaning, etc., to obtain a completely shaped prosthesis.
In one embodiment, the free loose metal dust adhering to the blank and dust particles between the prosthetic fixation surface and the protective layer may be removed by physical means using vacuum and/or electrostatic adsorption.
In one embodiment, the binder on the surface of the green body may be removed by a similar principle of miscibility using a chemical solvent.
The invention also provides a biological anchoring artificial joint prosthesis produced by the above-described production method, as shown in fig. 3, the prosthesis 1 having a prosthesis anchoring face 4 and a contact face, the contact face comprising a friction face 11 or a sliding face,
The prosthesis fixation surface comprising a porous metal surface and a non-porous roughened metal surface, the prosthesis fixation surface 4 for biological fixation with a host bone,
The friction surface 11 is a zirconia or titania ceramic surface obtained by surface oxidation treatment of the base metal of the prosthesis 1, and the friction surface 11 or sliding surface has a sliding function;
The prosthesis fixing surface 4 and the prosthesis base body 1 are integrally formed, a protecting device 2 capable of preventing the oxidizing gas from penetrating into the prosthesis fixing surface 4 is printed out at the periphery of the prosthesis fixing surface in the forming process, after high-temperature oxidation treatment, the protecting device 2 is separated from the prosthesis 1 through machining, and the prosthesis fixing surface 4 retains the chemical characteristics of the 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 nonporous rough metal surface for biological fixation with a host bone and a friction surface for sliding, the friction surface is zirconia or titanium oxide ceramic generated by high-temperature oxidation treatment on the surface of the base metal, the biological fixation surface of the prosthesis is formed together with a prosthesis base body by an additive manufacturing or 3D printing method, a protective device capable of preventing oxidative gas from penetrating into the biological fixation surface is printed around the biological fixation surface in the forming process, and after the high-temperature oxidation treatment, the protective device is separated from the prosthesis by machining, and the biological fixation surface of the prosthesis maintains the chemical characteristics of the base metal.
Further, the application range of the artificial joint prosthesis includes: the artificial knee joint comprises a cuboid condyle and a tibial plateau which are biological fixed knee joints, an acetabular cup which is biological fixed hip joints and a ball head for surface replacement of the hip joints. The prosthesis has the advantages of wear resistance and corrosion resistance of the ceramic friction surface, and the capability of promoting bone growth or bone ingrowth of the biological fixing surface which retains the chemical characteristics of the matrix metal.
Example 3:
referring to fig. 4-5, the present invention provides a method for manufacturing a biological anchoring artificial joint prosthesis based on a method of combining metal deposition (binder metal deposition) green body molding and sintering molding, comprising:
Firstly, a design engineer designs a prosthesis 1 and a protection device 2 of a prosthesis fixing surface 4, and then converts the design into a digital model which can be formed by digital 3D printing, a layer of Anti-sintering isolation layer 5 (Anti-SINTERING AGENT) capable of preventing the prosthesis fixing surface 4 and the protection device 2 from reacting (sintering) in a high-temperature environment is arranged between the prosthesis biological fixing surface 4 and the protection device 2, and the Anti-sintering isolation layer 5 is generally made of ceramic materials resistant to high-temperature reaction, as shown in fig. 4;
The digitization model of the prosthesis 1 and the protection device 2 is then input into a special green body molding 3D printer with double spray heads, such as a "Studio System" or Markforged "Metal X" System of a Desktop Metal, which is generally provided with two different raw material boxes and corresponding spray heads, the first raw material box is provided with a mixture of Metal powder and binder mixed in proportion, and the second raw material box is provided with anti-sintering ceramic material; starting a printer to mold the green bodies of the prosthesis 1 and the protecting device 2 at one time;
Removing the adhesive in the blank body through the relevant solvent, and drying, wherein the adhesive is evaporated and discharged from the holes 3;
Placing the blank into a high-temperature vacuum furnace, and sintering and forming at a temperature slightly lower than the melting point of the metal material of the prosthesis;
then carrying out necessary grinding and polishing treatment on the friction surface 11 of the sintered prosthesis 1;
Then placing the sintered part processed in the step S5 into a heat treatment furnace, and carrying out surface oxidation treatment at high temperature in an oxygen-containing environment; the prosthesis fixation surface 4 of the prosthesis 1 is isolated from oxygen or active gases due to the presence of the dense peripheral protective layer, so that no chemical reaction occurs, and the sintering cannot be generated again between the prosthesis fixation surface 4 and the protective layer due to the presence of the anti-sintering isolation layer 5, so that the prosthesis fixation surface can be separated after heat treatment without changing the chemical and physical properties of the fixation surface;
the peripheral sealing layer of the protector 2 is then removed by machining, such as wire cutting, and the peripherally cut protector 2 will be easily separated from the prosthesis itself, as shown in fig. 5, due to the inclusion of an anti-sintering barrier layer 5 between the prosthesis fixation face 4 and the protective layer.
Finally, the prosthesis 1, from which the protective device 2 has been stripped, is subjected to the necessary post-treatments, such as polishing, cleaning, etc., to obtain a shaped prosthesis.
In one embodiment, the free loose metal dust adhering to the blank and dust particles between the prosthetic fixation surface and the protective layer are removed by physical means using vacuum and/or electrostatic adsorption.
In one embodiment, the binder on the surface of the green body is removed by a similar principle of miscibility using a chemical solvent.
The artificial joint prosthesis and the molding method of the fixing surface anti-oxidation protection device are characterized in that a green body is printed layer by extruding a mixture of metal powder and a binder through a nozzle, and a layer of ceramic powder for preventing high-temperature sintering is added between the biological fixing surface of the prosthesis and the anti-oxidation protection device, so that the biological fixing surface can keep the chemical characteristics of matrix metal and the original geometric morphology of a bone fixing surface in the subsequent sintering and high-temperature oxidation processes.
The invention also provides a biological anchoring artificial joint prosthesis produced by the above-described production method, as shown in fig. 3, the prosthesis 1 having a prosthesis anchoring face 4 and a contact face, the contact face comprising a friction face 11 or a sliding face,
The prosthetic fixation surface 4 comprises a porous metal surface and a non-porous roughened metal surface, the prosthetic fixation surface 4 is for biostatic with a host bone,
The friction surface 11 is a zirconia or titania ceramic surface obtained by surface oxidation treatment of the base metal of the prosthesis 1, and the friction surface 11 or sliding surface has a sliding function;
The prosthesis fixation surface 4 and the prosthesis base body 1 are integrally formed, and a protecting device 2 capable of preventing the oxidizing gas from penetrating into the prosthesis fixation surface 4 is printed out at the same time around the prosthesis fixation surface 4 in the forming process, after high-temperature oxidation treatment, the protecting device 2 is separated from the prosthesis 1 through machining, and the prosthesis fixation surface 4 retains the chemical characteristics of the 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 nonporous rough metal surface for biological fixation with a host bone and a friction surface for sliding, the friction surface is zirconia or titanium oxide ceramic generated by high-temperature oxidation treatment on the surface of the base metal, the biological fixation surface of the prosthesis is formed together with a prosthesis base body by an additive manufacturing or 3D printing method, a protective device capable of preventing oxidative gas from penetrating into the biological fixation surface is printed around the biological fixation surface in the forming process, and after the high-temperature oxidation treatment, the protective device is separated from the prosthesis by machining, and the biological fixation surface of the prosthesis maintains the chemical characteristics of the base metal.
Further, the application range of the artificial joint prosthesis includes: the artificial knee joint comprises a cuboid condyle and a tibial plateau which are biological fixed knee joints, an acetabular cup which is biological fixed hip joints and a ball head for surface replacement of the hip joints. The prosthesis has the advantages of wear resistance and corrosion resistance of the ceramic friction surface, and the capability of promoting bone growth or bone ingrowth of the biological fixing surface which retains the chemical characteristics of the matrix metal.
By combining the embodiments 1 to 3, the biological fixed artificial joint prosthesis and the manufacturing method and the application thereof provided by the invention really solve the problems existing in the prior art, and provide the prosthesis with better performance and more meeting the requirements of human environment for the medical field.
The invention uses the protection device to isolate and protect the fixing surface of the prosthesis without surface oxidation treatment, so that the base metal of the prosthesis does not reach the fixing surface of the prosthesis when the surface oxidation treatment is carried out, and the strength and toughness of the material at the fixing surface of the prosthesis are ensured;
Compared with the prosthesis prepared by the prior art, the prosthesis prepared by the preparation method solves the problem that the metal surface of the matrix is completely oxidized and ceramic by improving the processing mode, and the ceramic porous structure seriously influences the strength and toughness of the matrix of the prosthesis;
The prosthesis prepared by the preparation method comprises a friction surface or a sliding surface and a biological fixation surface with rough or porous surface; the friction surface of the prosthesis is oxide which is similar to ceramic performance and directly grows from a matrix through high-temperature oxidation heat treatment, and the biological fixing surface of the prosthesis is a rough or porous structure which keeps the chemical components of the matrix metal, so that different parts of the prosthesis have different physical properties, the service performance is improved, and the prosthesis is purposefully modified to meet the requirements of human environment in the process of being used;
the principle of the manufacturing method is that the protecting device is used for isolating the part of the prosthesis which does not need surface oxidation, and in the manufacturing process, the protecting device and the prosthesis are integrally formed, so that the sealing performance is better, the isolating effect is better, and only the part of the matrix metal of the prosthesis exposed outside the protecting device is oxidized;
In the manufacturing method, because the prosthesis protection device is used, the fixing surface of the prosthesis is isolated from oxygen or active gas, no chemical reaction exists, and the sintering cannot be generated again between the biological fixing surface of the prosthesis and the protection layer due to the existence of the sintering-resistant ceramic layer, so that the prosthesis can be separated after heat treatment without changing the chemical and physical properties of the fixing surface;
The prosthesis protection device in the manufacturing method can be removed from the prosthesis by machining, for example, the peripheral sealing layer of the prosthesis protection device is removed by wire cutting, and the protection device after peripheral cutting is easily separated from the prosthesis itself because the anti-sintering isolation layer is arranged between the biological fixing surface of the prosthesis and the protection layer;
The prosthesis prepared by the preparation method is a prosthesis with both friction surface function and bone fixation surface function, and comprises but is not limited to artificial knee joint cuboid condyle, artificial knee joint tibia platform with double sliding design, artificial hip joint acetabular cup with double sliding design, hip joint cuboid ball head for surface replacement and the like; the prosthesis has the wear-resistant and corrosion-resistant performances of the ceramic friction surface, and also retains the performances of promoting bone growth or bone ingrowth of the biological fixing surface with the chemical characteristics of the matrix metal;
the forming method of the prosthesis and the protecting device can realize that the physical and chemical characteristics of the matrix metal and the original geometric morphology of the bone fixing surface of the biological matrix and the fixing surface can be maintained in the subsequent sintering and high-temperature oxidation processes, and the manufactured prosthesis is more suitable for human environment and has more practicability;
The manufacturing method is primarily realized by using computer software and a 3D printer, is easy to realize in terms of the speed of technological development at present, and is more convenient to realize along with the progress of the technology, so that the manufacturing method is connected with the era, the technology is promoted to progress, the technological development is promoted to progress, and a virtuous circle is formed.
In the description of the present specification, a description referring to terms "one embodiment," "some embodiments," "examples," "specific examples," or "some examples," etc., means 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 present invention. In this specification, schematic representations of the above terms are not necessarily directed 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. Further, one skilled in the art may combine and combine the different embodiments or examples described in this specification.
While embodiments of the present invention have been shown and described above, it will be understood that the above embodiments are illustrative and not to be construed as limiting the invention, and that variations, modifications and alternatives to the above embodiments may be made by those skilled in the art within the scope of the invention.
Claims (10)
1. A method for manufacturing a biological fixed artificial joint prosthesis, which 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: printing and molding the digital prosthesis model obtained in the step S1 into a whole by using a 3D printer to obtain a prosthesis blank, wherein the prosthesis blank is provided with a prosthesis 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 holes of a protection device on the sintered prosthesis blank under vacuum to obtain a one-time preformed prosthesis, wherein the protection device is arranged on the prosthesis fixing surface (4), and one or more holes (3) are formed in the protection device;
S4: grinding, polishing and cleaning the friction surface (11) 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: removing the protective device (2) on the secondary preformed prosthesis obtained in the step S4 to obtain the formed prosthesis (1).
2. The method according to claim 1, wherein in step S2,
The diameter of the hole (3) is larger than 0.5mm; 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 deposited by laying the prosthesis base metal powder layer by layer and selectively adhering the powder.
3. The method according to claim 1, wherein in step S2, the prosthesis body further comprises an anti-sintering barrier layer (5),
The anti-sintering isolation layer (5) is arranged between the prosthesis fixing surface (4) and the protection device (2), and the anti-sintering isolation layer (5) comprises a ceramic material resistant to high-temperature reaction.
4. The manufacturing method according to claim 1, wherein in step S2, the 3D printer is selected from a laser melted 3D printer or a selective electron beam melted 3D printer; the 3D printer is a green body molding printer filled with metal powder and a binder and is provided with a double spray head;
One of the two spray heads sprays a mixture, and the other of the two spray heads sprays a sintering-preventing ceramic material;
The mixture includes a mixture of metal powder and a binder mixed in a certain ratio.
5. The method of claim 1, wherein in step S3, the residual impurities include free loose metal dust adhering to the body, dust particles between the prosthesis fixation face (4) and the protection means, and a binder on the surface of the body of the prosthesis;
And (3) sealing the holes (3) on the protective layer of the prosthesis blank body under vacuum after the prosthesis blank body is sintered and formed in a vacuum furnace.
6. The method of manufacture according to claim 5, characterized in that the free loose metal dust adhering to the blank and dust particles between the prosthesis fixation face (4) and the protection means 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 a similar compatibility principle;
the sintering temperature of the prosthesis blank in a vacuum furnace is lower than the melting point of the metal material;
the holes on the protective layer of the prosthesis blank are sealed by laser welding.
7. The method according to claim 1, wherein in step S4, the one-time preformed prosthesis is subjected to surface oxidation treatment in a high-temperature oxygen-containing heat treatment furnace.
8. The method of manufacturing according to claim 1, characterized in that in step S5 the secondary preformed prosthesis is machined to remove the protective device (2).
9. The biological anchoring artificial joint prosthesis produced by the production method according to any one of claims 1 to 8, characterized in that the prosthesis (1) has an anchoring surface (4) and a contact surface, which comprises a friction surface (11) or a sliding surface,
The prosthesis fixation surface (4) comprises a porous metal surface and a non-porous roughened metal surface,
The friction surface (11) is a zirconia or titania ceramic surface obtained by surface oxidation treatment of the base metal of the prosthesis (1);
The prosthesis fixing surface (4) and the prosthesis (1) matrix 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 biosolidated artificial joint prosthesis of claim 9, wherein the artificial joint prosthesis is applied to the cuboid condyle and tibial plateau of a biosolidated knee joint, the acetabular cup of a biosolidated hip joint, and the ball head of a surface replacement hip joint.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202010350825.1A CN113558829B (en) | 2020-04-28 | 2020-04-28 | Biological fixed artificial joint prosthesis and manufacturing method and application thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202010350825.1A CN113558829B (en) | 2020-04-28 | 2020-04-28 | Biological fixed artificial joint prosthesis and manufacturing method and application thereof |
Publications (2)
| Publication Number | Publication Date |
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| CN113558829A CN113558829A (en) | 2021-10-29 |
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| 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·***·麦克明 | Method of forming polymeric component |
| 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 |
| 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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| 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·***·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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| 复合型人工半膝关节制造方法研究;贺健康;李涤尘;卢秉恒;王臻;张涛;;中国机械工程(第S1期);全文 * |
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