CN116919668A - Method for manufacturing a unicondylar prosthesis system and unicondylar prosthesis system - Google Patents
Method for manufacturing a unicondylar prosthesis system and unicondylar prosthesis system Download PDFInfo
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- CN116919668A CN116919668A CN202310938948.0A CN202310938948A CN116919668A CN 116919668 A CN116919668 A CN 116919668A CN 202310938948 A CN202310938948 A CN 202310938948A CN 116919668 A CN116919668 A CN 116919668A
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- 238000004519 manufacturing process Methods 0.000 title claims abstract description 29
- 238000000034 method Methods 0.000 title claims abstract description 25
- 210000000988 bone and bone Anatomy 0.000 claims abstract description 129
- 239000013067 intermediate product Substances 0.000 claims abstract description 42
- 229910001257 Nb alloy Inorganic materials 0.000 claims abstract description 33
- GFUGMBIZUXZOAF-UHFFFAOYSA-N niobium zirconium Chemical compound [Zr].[Nb] GFUGMBIZUXZOAF-UHFFFAOYSA-N 0.000 claims abstract description 33
- 239000000843 powder Substances 0.000 claims abstract description 26
- 238000003754 machining Methods 0.000 claims abstract description 23
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 claims abstract description 19
- 238000010438 heat treatment Methods 0.000 claims abstract description 15
- 239000002923 metal particle Substances 0.000 claims abstract description 12
- 238000007639 printing Methods 0.000 claims abstract description 12
- 238000007493 shaping process Methods 0.000 claims abstract description 11
- 238000010301 surface-oxidation reaction Methods 0.000 claims abstract description 8
- 239000002994 raw material Substances 0.000 claims abstract description 5
- 238000001816 cooling Methods 0.000 claims description 34
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 claims description 16
- 238000010146 3D printing Methods 0.000 claims description 13
- 239000007788 liquid Substances 0.000 claims description 10
- XKRFYHLGVUSROY-UHFFFAOYSA-N Argon Chemical compound [Ar] XKRFYHLGVUSROY-UHFFFAOYSA-N 0.000 claims description 8
- 239000011195 cermet Substances 0.000 claims description 8
- 229910052757 nitrogen Inorganic materials 0.000 claims description 8
- 230000001105 regulatory effect Effects 0.000 claims description 8
- 210000002303 tibia Anatomy 0.000 claims description 7
- 210000000689 upper leg Anatomy 0.000 claims description 7
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 claims description 5
- 239000001301 oxygen Substances 0.000 claims description 5
- 229910052760 oxygen Inorganic materials 0.000 claims description 5
- 239000002245 particle Substances 0.000 claims description 5
- 229910052786 argon Inorganic materials 0.000 claims description 4
- 238000004140 cleaning Methods 0.000 claims description 4
- 238000001035 drying Methods 0.000 claims description 4
- 239000001307 helium Substances 0.000 claims description 4
- 229910052734 helium Inorganic materials 0.000 claims description 4
- SWQJXJOGLNCZEY-UHFFFAOYSA-N helium atom Chemical compound [He] SWQJXJOGLNCZEY-UHFFFAOYSA-N 0.000 claims description 4
- 238000001513 hot isostatic pressing Methods 0.000 claims description 4
- 239000011261 inert gas Substances 0.000 claims description 4
- 239000013081 microcrystal Substances 0.000 claims description 4
- 238000005498 polishing Methods 0.000 claims description 4
- 238000007730 finishing process Methods 0.000 claims description 3
- 238000009966 trimming Methods 0.000 claims description 2
- 238000004513 sizing Methods 0.000 claims 1
- 230000011164 ossification Effects 0.000 abstract description 11
- JLVVSXFLKOJNIY-UHFFFAOYSA-N Magnesium ion Chemical compound [Mg+2] JLVVSXFLKOJNIY-UHFFFAOYSA-N 0.000 description 11
- 229910001425 magnesium ion Inorganic materials 0.000 description 11
- 230000004927 fusion Effects 0.000 description 10
- 230000008569 process Effects 0.000 description 10
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- 239000000919 ceramic Substances 0.000 description 6
- 229910052751 metal Inorganic materials 0.000 description 6
- 239000002184 metal Substances 0.000 description 6
- 208000012659 Joint disease Diseases 0.000 description 5
- 238000005299 abrasion Methods 0.000 description 5
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- 239000012530 fluid Substances 0.000 description 4
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- 230000009818 osteogenic differentiation Effects 0.000 description 4
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- 238000010586 diagram Methods 0.000 description 3
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- 241000270322 Lepidosauria Species 0.000 description 1
- 206010058046 Post procedural complication Diseases 0.000 description 1
- 208000035965 Postoperative Complications Diseases 0.000 description 1
- 208000037099 Prosthesis Failure Diseases 0.000 description 1
- 206010066902 Surgical failure Diseases 0.000 description 1
- 230000032683 aging Effects 0.000 description 1
- 239000012620 biological material Substances 0.000 description 1
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- 239000007943 implant Substances 0.000 description 1
- 230000003993 interaction Effects 0.000 description 1
- 230000008407 joint function Effects 0.000 description 1
- 238000010329 laser etching Methods 0.000 description 1
- 238000007648 laser printing Methods 0.000 description 1
- 229910052749 magnesium Inorganic materials 0.000 description 1
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- 239000000395 magnesium oxide Substances 0.000 description 1
- AXZKOIWUVFPNLO-UHFFFAOYSA-N magnesium;oxygen(2-) Chemical compound [O-2].[Mg+2] AXZKOIWUVFPNLO-UHFFFAOYSA-N 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
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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
- A61F2/38—Joints for elbows or knees
- A61F2/3859—Femoral components
Landscapes
- Health & Medical Sciences (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Physical Education & Sports Medicine (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
The application relates to the technical field of medical equipment, in particular to a method for manufacturing a unicondylar prosthesis system and the unicondylar prosthesis system, wherein the method for manufacturing the unicondylar prosthesis system comprises the steps of using zirconium-niobium alloy powder as a raw material, sequentially printing a first intermediate product of a femoral condyle prosthesis by using a first body and a first bone trabecular structure layer, and sequentially printing a first intermediate product of a tibial plateau prosthesis by using a second body and a second bone trabecular structure layer; adding magnesium metal particles to the zirconium niobium alloy powder when printed to a first bone trabecular structure layer of the femoral condyle bone prosthesis and when printed to a second bone trabecular structure layer of the tibial plateau prosthesis; heat treatment; machining and shaping; and (5) surface oxidation treatment. According to the manufacturing method of the unicondylar prosthesis system and the unicondylar prosthesis system, provided by the application, the osteogenesis speed of an elderly patient is effectively improved, and the occurrence rate of aseptic loosening is reduced.
Description
Technical Field
The application relates to the technical field of medical equipment, in particular to a manufacturing method of a unicondylar prosthesis system and the unicondylar prosthesis system.
Background
With the advent of the aged society, joint diseases have increased. Meanwhile, as the requirements of people on health are higher due to social progress, the number of joint replacement is dramatically increased. The joint prosthesis replacement is a surgical treatment method, and mainly aims to restore joint functions, relieve pain and improve the life quality of patients. Although joint replacement procedures and techniques are currently clinically standardized, various complications occur after joint replacement, resulting in surgical failure and the need for surgical revision. The loosening of the interface between the prosthesis and the bone is the main cause of the failure of the prosthesis, the cause of the loosening of the prosthesis is quite complex, and the aseptic loosening is the most common postoperative complication.
Among causes of failure of the joint prosthesis, poor fusion between the bone interface and the prosthesis is one of causes of aseptic loosening, as society ages, the average age of the joint disease patient group gradually increases, the elderly patients in the joint disease patient group increase, and the elderly patients are slow in metabolism and slow in osteogenesis, which results in slow fusion between the bone interface and the prosthesis, and the phenomenon of poor fusion is extremely easy to occur.
Furthermore, active wear is one of the most leading causes of aseptic loosening. It is counted that the active wear failure rate is about 50-60% within 10 years after the artificial joint replacement operation. As the service life increases, the duty cycle of the active wear failure also increases gradually. Therefore, reducing the active wear of the joint prosthesis is one of the important means to increase the life of the joint prosthesis and reduce failure rate.
Disclosure of Invention
The application aims to provide a manufacturing method of a unicondylar prosthesis system and the unicondylar prosthesis system, which solve the technical problems that the average age value of a joint disease patient group gradually increases along with the aging of society, the elderly patients in the joint disease patient group increase, the metabolism of the elderly patients is slow, the osteogenesis speed is slow, the fusion speed between a bone interface and a prosthesis is slow, and fusion failure is easy to occur in the prior art to a certain extent.
According to a first aspect of the present application there is provided a method of manufacturing a unicondylar prosthesis system comprising a femoral condyle bone prosthesis and a tibial plateau prosthesis mated to each other;
the femoral condyle bone prosthesis comprises a first body and a first bone trabecular structure layer arranged on the first body, wherein the first bone trabecular structure layer is used for fusing with a femur;
the tibial plateau prosthesis comprises a second body and a second bone trabecular structure layer arranged on the second body, wherein the second bone trabecular structure layer is used for being fused with tibia;
wherein the method of manufacturing the unicondylar prosthesis system comprises the steps of:
3D printing and integrally forming, namely sequentially printing the first body and the first bone trabecular structure layer to form a first intermediate product of the femoral condyle bone prosthesis, and sequentially printing the second body and the second bone trabecular structure layer to form a first intermediate product of the tibial plateau prosthesis by using zirconium-niobium alloy powder as a raw material;
adding magnesium metal particles to the zirconium niobium alloy powder when printed to a first bone trabecular structure layer of the femoral condyle bone prosthesis and when printed to a second bone trabecular structure layer of the tibial plateau prosthesis;
heat treating, respectively, the first intermediate product of the femoral condyle prosthesis and the first intermediate product of the tibial plateau prosthesis;
machining and shaping, namely respectively and sequentially carrying out machining and trimming treatment, polishing treatment, cleaning treatment and drying treatment on the femoral condyle prosthesis and the tibial plateau prosthesis after the heat treatment step;
and (3) carrying out surface oxidation treatment, namely respectively placing the femoral condyle prosthesis and the tibial plateau prosthesis which are subjected to the machining shaping step in a tube furnace, introducing normal-pressure inert gas with the oxygen content of 5-15% by mass, heating to 500-700 ℃ at 5-20 ℃/min, cooling to 400-495 ℃ at 0.4-0.9 ℃/min, naturally cooling to below 200 ℃, and taking out.
Preferably, the grain size of the zirconium niobium alloy powder is 5 μm to 150 μm;
the particle diameter of the magnesium metal particles is 5-10 mu m.
Preferably, the addition amount of the magnesium metal particles is 1% -5% of the volume of the zirconium niobium alloy powder.
Preferably, the first step is that a first intermediate product of the femoral condyle prosthesis and the tibial plateau prosthesis is obtained through 3D printing and integrated molding, and is put into a hot isostatic pressing furnace, and is heated to 1250 ℃ to 1400 ℃ under the protection of helium or argon, is placed at a constant temperature of 140MPa to 180MPa for 1h to 3h, is cooled to normal pressure along with the furnace, is taken out after being cooled to 200 ℃ or lower, and is obtained as a second intermediate product of the femoral condyle prosthesis and the tibial plateau prosthesis;
step two, placing a second intermediate product of the femoral condyle prosthesis and the tibial plateau prosthesis in a procedural cooling box, cooling to-80 ℃ to-120 ℃ at a speed of 1 ℃/min, placing at constant temperature for 5-10 h, and taking out from the procedural cooling box; placing the femoral condyle prosthesis and the tibial plateau prosthesis in liquid nitrogen for 16-36 h again, and regulating the temperature to room temperature to obtain a third intermediate product of the femoral condyle prosthesis and the tibial plateau prosthesis;
step three, placing a third intermediate product of the femoral condyle prosthesis and the tibial plateau prosthesis in a procedural cooling box, cooling to-80 ℃ to-120 ℃ at a speed of 1 ℃/min, and placing at constant temperature for 5-10 h; taking out from the procedural cooling box; placing in liquid nitrogen for 16-36 h, and regulating the temperature to room temperature; a fourth intermediate product of both the femoral condyle prosthesis and the tibial plateau prosthesis is obtained.
Preferably, in the machining shaping step, the machining finishing process further includes micro-texturing the surface of the first body and/or the second body using a high-precision machining apparatus.
According to a second aspect of the present application, there is provided a unicondylar prosthesis system, and a method for manufacturing the same according to any of the above embodiments, which has all the advantages and advantages of the method for manufacturing a unicondylar prosthesis system, and will not be described in detail herein.
In particular, the unicondylar prosthesis system comprises a femoral condyle bone prosthesis and a tibial plateau prosthesis that cooperate with each other;
the femoral condyle bone prosthesis comprises a first body and a first bone trabecular structure layer arranged on the first body, wherein the first bone trabecular structure layer is used for fusing with a femur;
the tibial plateau prosthesis comprises a second body and a second bone trabecular structure layer arranged on the second body, wherein the second bone trabecular structure layer is used for being fused with tibia;
the first body and the first bone trabecular structure layer are integrally formed through 3D printing of zirconium-niobium alloy powder;
the second body and the second bone trabecular structure layer are integrally formed through 3D printing of zirconium-niobium alloy powder.
Preferably, the thickness of the first bone trabecular structure layer is 2 mm-6 mm;
the thickness of the second bone trabecular structure layer is 2 mm-6 mm.
Preferably, further comprising a microtexture;
the micro-texture is arranged on the surface of the part of the first body where the first bone trabecular structure layer is not arranged, and/or
The micro-texture is disposed on a surface of a portion of the second body where the second bone trabecular structure layer is not disposed.
Preferably, the micro-texture comprises a plurality of micro-crystalline portions densely arranged;
the micro-texture is nano-scale micro-texture and/or micro-scale micro-texture;
the microcrystal part is a protruding part or a recessed part.
Preferably, the surfaces of both the femoral condyle prosthesis and the tibial plateau prosthesis are coated with a cermet layer;
the thickness of the metal ceramic layer is 3-35 mu m.
Compared with the prior art, the application has the beneficial effects that:
according to the manufacturing method of the unicondylar prosthesis system, magnesium metal is added into zirconium-niobium alloy powder for printing the first bone trabecular structure layer and the second bone trabecular structure layer, and the magnesium metal is oxidized and converted into magnesium ions through surface oxidation treatment. In the clinical use process, the first bone trabecula structural layer and the second bone trabecula structural layer can release magnesium ions, and the released magnesium ions can effectively promote bone cell calcification, promote bone cell proliferation, inhibit inflammation, promote osteogenic differentiation and stimulate osteogenesis, thereby being beneficial to the integration of a prosthesis and a bone interface and improving the stability of the implanted prosthesis. Furthermore, the osteogenesis speed of the elderly patients is effectively improved, and the occurrence probability of aseptic loosening is reduced.
In order to make the above objects, features and advantages of the present application more comprehensible, preferred embodiments accompanied with figures are described in detail below.
Drawings
In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings that are needed in the description of the embodiments or the prior art will be briefly described, and it is obvious that the drawings in the description below are some embodiments of the present application, and other drawings can be obtained according to the drawings without inventive effort for a person skilled in the art.
FIG. 1 is a schematic illustration of a unicondylar prosthesis system provided in an embodiment of the present application;
fig. 2 is a schematic view of a tibial plateau prosthesis according to an embodiment of the present application;
FIG. 3 is a schematic diagram of an exemplary micro-texture structure provided by an embodiment of the present application;
FIG. 4 is a schematic view of another exemplary micro-texture provided by an embodiment of the present application;
FIG. 5 is a schematic view of a microstructure of another example provided by an embodiment of the present application;
FIG. 6 is a process flow diagram of a method of manufacturing a femoral condyle bone prosthesis, in accordance with an embodiment of the present application;
fig. 7 is a process flow diagram of a method of manufacturing a tibial plateau prosthesis provided in an embodiment of the present application.
Reference numerals:
1-femoral condyle bone prosthesis; 11-a first body; 12-a first trabecular bone structural layer; 2-tibial plateau prosthesis; 21-a second body; 22-a second trabecular bone structural layer; 3-microtexture.
Detailed Description
The following description of the embodiments of the present application will be made apparent and fully in view of the accompanying drawings, in which some, but not all embodiments of the application are shown.
The components of the embodiments of the present application generally described and illustrated in the figures herein may be arranged and designed in a wide variety of different configurations. Thus, the following detailed description of the embodiments of the application, as presented in the figures, is not intended to limit the scope of the application, as claimed, but is merely representative of selected embodiments of the application.
All other embodiments, which can be made by those skilled in the art based on the embodiments of the application without making any inventive effort, are intended to be within the scope of the application.
In the description of the present application, it should be noted that the directions or positional relationships indicated by the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. are based on the directions or positional relationships shown in the drawings, are merely for convenience of describing the present application and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a specific orientation, be configured and operated in a specific orientation, and thus should not be construed as limiting the present application. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.
In the description of the present application, it should be noted that, unless explicitly specified and limited otherwise, the terms "mounted," "connected," and "connected" are to be construed broadly, and may be either fixedly connected, detachably connected, or integrally connected, for example; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the above terms in the present application will be understood in specific cases by those of ordinary skill in the art.
Methods of manufacturing a unicondylar prosthetic system and unicondylar prosthetic systems according to some embodiments of the present application are described below with reference to fig. 1-6.
Referring to fig. 1-6, an embodiment of a first aspect of the present application provides a method of manufacturing a unicondylar prosthesis system. Wherein the unicondylar prosthesis system comprises a femoral condyle prosthesis 1 and a tibial plateau prosthesis 2 which are matched with each other; the femoral condyle bone prosthesis 1 includes a first body 11 and a first trabecular structure layer 12 disposed on the first body 11, the first trabecular structure layer 12 being for fusion with a femur. The tibial plateau prosthesis 2 includes a second body 21 and a second bone trabecular structural layer 22 disposed in the second body 21, the second bone trabecular structural layer 22 being for fusion with the tibia.
Specifically, the method of manufacturing the unicondylar prosthesis system includes a method of manufacturing the femoral condyle bone prosthesis 1 and a method of manufacturing the tibial plateau prosthesis 2.
As shown in fig. 6, the method for manufacturing the femoral condyle prosthesis 1 includes the steps of:
the SG01 femoral condyle prosthesis 13D is integrally formed by printing, using zirconium-niobium alloy powder as a raw material, and sequentially printing the first body 11 and the first trabecular bone structural layer 12 to form a first intermediate product of the femoral condyle prosthesis 1. Wherein magnesium metal particles are added to the zirconium niobium alloy powder when printed to the first bone trabecular structure layer 12 of the femoral condyle bone prosthesis 1.
SG02 heat treatment, the first intermediate product of the femoral condyle bone prosthesis 1 is heat treated to refine the internal structure of both the first body 11 and the first bone trabecular structure layer 12 to improve the overall strength of the femoral condyle bone prosthesis 1.
The SG03 machining and shaping, and the femoral condyle bone prosthesis 1 after the heat treatment step is sequentially subjected to machining and finishing treatment, polishing treatment, cleaning treatment and drying treatment.
The SG04 surface oxidation treatment, namely placing the femoral condyle prosthesis 1 which completes the machining shaping step into a tubular furnace, introducing normal pressure inert gas with the oxygen content of 5-15% by mass, heating to 500-700 ℃ at 5-20 ℃/min, cooling to 400-495 ℃ at 0.4-0.9 ℃/min, naturally cooling to below 200 ℃ and taking out the femoral condyle prosthesis, so as to oxidize the surface of the femoral condyle prosthesis, and forming the following metal ceramic layers on the surfaces of the first body 11 and the first trabecula to improve the wear resistance of the surface of the femoral condyle prosthesis.
As shown in fig. 7, the method for manufacturing the tibial plateau prosthesis 2 includes the steps of:
the SJ01 tibial plateau prosthesis 23D is printed and integrally formed, and zirconium-niobium alloy powder is used as a raw material, and the second body 21 and the second bone trabecular structure layer 22 are printed in sequence to form a first intermediate product of the tibial plateau prosthesis 2. Wherein magnesium metal particles are added to the zirconium niobium alloy powder when printed to the first bone trabecular structure layer 12 of the tibial plateau prosthesis 2.
SJ02 heat treatment, heat treatment of the first intermediate product of the tibial plateau prosthesis 2 to refine the internal structure of both the first body 11 and the first bone trabecular structural layer 12 to improve the overall strength of the tibial plateau prosthesis 2.
SJ03 machining and shaping, and sequentially performing machining and finishing treatment, polishing treatment, cleaning treatment and drying treatment on the tibial plateau prosthesis 2 subjected to the heat treatment step.
SJ04 surface oxidation treatment, namely placing the tibial plateau prosthesis 2 subjected to the machining shaping step in a tubular furnace, introducing normal-pressure inert gas with the oxygen content of 5-15% by mass, heating to 500-700 ℃ at 5-20 ℃/min, cooling to 400-495 ℃ at 0.4-0.9 ℃/min, naturally cooling to below 200 ℃ and taking out the tibial plateau prosthesis, so as to perform oxidation treatment on the surface of the femoral condyle prosthesis, and forming the following metal ceramic layers on the surfaces of the first body 11 and the first bone trabeculae to improve the wear resistance of the surface of the femoral condyle prosthesis.
According to the above technical features, magnesium metal is added to the zirconium niobium alloy powder for printing both the first bone trabecular structure layer 12 and the second bone trabecular structure layer 22, and oxidation conversion of the magnesium metal into magnesium ions occurs by the surface oxidation treatment. In the clinical use process, the first bone trabecular structure layer 12 and the second bone trabecular structure layer 22 can release magnesium ions, and the released magnesium ions can effectively promote bone cell calcification, promote bone cell proliferation, inhibit inflammation, promote osteogenic differentiation and stimulate osteogenesis, thereby being beneficial to the integration of a prosthesis and a bone interface and improving the stability of the implanted prosthesis. Furthermore, the osteogenesis speed of the elderly patients is effectively improved, and the occurrence probability of aseptic loosening is reduced.
Preferably, the grain size of the zirconium niobium alloy powder is 5 μm to 150 μm, so that the printing and forming of the femoral condyle prosthesis 1 and the tibial plateau prosthesis 2 are convenient, and the uniformity of the printing and forming structures of the femoral condyle prosthesis 1 and the tibial plateau prosthesis 2 is ensured.
Preferably, the particle size of the magnesium metal particles is 5-10 μm to ensure the fusion uniformity of the magnesium metal and the zirconium-niobium alloy.
Preferably, the above magnesium metal particles may be added in an amount of 1% -5% by volume of the magnesium metal particles based on the volume of the zirconium niobium alloy powder to ensure that both the first and second bone trabecular structural layers 12, 22 are capable of releasing sufficient magnesium ions to ensure the effectiveness of the magnesium ions in promoting bone formation.
Preferably, as shown in fig. 6, the step of SG02 heat treatment may specifically include:
SG021, the first intermediate product of the femoral condyle bone prosthesis 1 is obtained through 3D printing and integrated forming, the first intermediate product is placed into a hot isostatic pressing furnace, the temperature is raised to 1250 ℃ to 1400 ℃ under the protection of helium or argon, the temperature is kept between 140MPa and 180MPa, the temperature is kept for 1h to 3h, the pressure is reduced to normal pressure, and the second intermediate product of the femoral condyle bone prosthesis 1 is obtained after cooling to below 200 ℃ along with the furnace.
SG022, placing a second intermediate product of the femoral condyle prosthesis 1 in a procedural cooling box, cooling to-80 ℃ to-120 ℃ at a speed of 1 ℃/min, placing at constant temperature for 5-10 h, and taking out from the procedural cooling box; and placing the femoral condyle prosthesis in liquid nitrogen for 16-36 h again, and regulating the temperature to room temperature to obtain a third intermediate product of the femoral condyle prosthesis 1.
SG023, placing the third intermediate product of the femoral condyle bone prosthesis 1 in a procedural cooling box, cooling to-80 ℃ to-120 ℃ at a speed of 1 ℃/min, and placing at constant temperature for 5-10 h; taking out from the procedural cooling box; placing in liquid nitrogen for 16-36 h, and regulating the temperature to room temperature; a fourth intermediate product of the femoral condyle prosthesis 1 is obtained.
Preferably, as shown in fig. 7, the step of SJ02 heat treatment may specifically include:
SJ021, the first intermediate product of the tibial plateau prosthesis 2 is obtained by 3D printing and integrated forming, the first intermediate product is put into a hot isostatic pressing furnace, the temperature is raised to 1250 ℃ to 1400 ℃ under the protection of helium or argon, the temperature is kept between 140MPa and 180MPa, the temperature is kept for 1h to 3h, the pressure is reduced to normal pressure, the temperature is cooled to below 200 ℃ along with the furnace, and the second intermediate product of the tibial plateau prosthesis 2 is obtained.
SJ022, placing the second intermediate product of the tibial plateau prosthesis 2 in a procedural cooling box, cooling to-80 ℃ to-120 ℃ at a speed of 1 ℃/min, placing at constant temperature for 5-10 h, and taking out from the procedural cooling box; and placing the tibial plateau prosthesis in liquid nitrogen for 16-36 h again, and regulating the temperature to room temperature to obtain a third intermediate product of the tibial plateau prosthesis 2.
SJ023, placing the third intermediate product of the tibial plateau prosthesis 2 in a procedural cooling box, cooling to-80 ℃ to-120 ℃ at a speed of 1 ℃/min, and placing at constant temperature for 5-10 h; taking out from the procedural cooling box; placing in liquid nitrogen for 16-36 h, and regulating the temperature to room temperature; a fourth intermediate product of the tibial plateau prosthesis 2 is obtained.
In an embodiment, in the above-described machining shaping step, the machining finishing process may further include performing the micro-texture 3 machining on the surface of the first body 11 and/or the second body 21 using a high-precision machining apparatus.
Alternatively, the above-described high-precision processing apparatus may be a micro-scale/nano-scale processing apparatus, for example, a femtosecond laser etching apparatus, a violet skin second laser printing apparatus, or the like.
The second aspect of the present application also provides a unicondylar prosthesis system manufactured by using the method for manufacturing a unicondylar prosthesis system according to any of the above embodiments, so that the method for manufacturing a unicondylar prosthesis system has all the beneficial technical effects, and will not be described herein.
In particular, the unicondylar prosthesis system comprises a femoral condyle bone prosthesis 1 and a tibial plateau prosthesis 2 that cooperate with each other. The femoral condyle bone prosthesis 1 comprises a first body 11 and a first bone trabecular structure layer 12 arranged on the first body 11, wherein the first bone trabecular structure layer 12 is used for fusion with a femur. Both the first body 11 and the first bone trabecular structural layer 12 are integrally molded via 3D printing of zirconium niobium alloy powder. Similarly, the tibial plateau prosthesis 2 includes a second body 21 and a second bone trabecular structural layer 22 disposed on the second body 21, the second bone trabecular structural layer 22 being for fusion with the tibia. Both the second body 21 and the second bone trabecular structural layer 22 are integrally molded via 3D printing of zirconium niobium alloy powder. In this way, the zirconium-niobium alloy has excellent corrosion resistance, mechanical properties and good biocompatibility, the prosthesis printed by the zirconium-niobium alloy powder has a smooth surface with low wear rate, the wear of the prosthesis in the use process is effectively reduced, and the first bone trabecular structure layer 12 and the second bone trabecular structure layer 22 of the 3D printed zirconium-niobium alloy have excellent biocompatibility, which is beneficial for the femoral condyle prosthesis 1 and the tibial plateau prosthesis 2 to be integrated with corresponding bone interfaces respectively.
Compared with the existing fixed unicondylar prosthesis system, the unicondylar prosthesis system provided by the application has the advantages that the tibial plateau prosthesis 2 made of zirconium-niobium alloy can save more bone quantity of the tibial plateau compared with the ultrahigh molecular weight polyethylene gasket in the prior art, and reserve more bone quantity for further revision of patients. And effectively avoid the risk of the prior art that the bone is dissolved due to the scraps generated by the abrasion of the ultra-high molecular weight polyethylene, thereby causing the loosening of the prosthesis.
Preferably, when the first bone trabecular structure layer 12 and the second bone trabecular structure layer 22 are 3D printed, magnesium metal is added into the zirconium-niobium alloy powder, so that the first bone trabecular structure layer 12 and the second bone trabecular structure layer 22 can release magnesium ions in the use process, and the released magnesium ions can effectively promote bone cell calcification, promote bone cell proliferation, inhibit inflammation, promote osteogenic differentiation and stimulate osteogenesis, thereby being beneficial to the integration of a prosthesis and a bone interface and improving the stability of the implanted prosthesis. Furthermore, the osteogenesis speed of the elderly patients is effectively improved, and the occurrence probability of aseptic loosening is reduced.
Preferably, the thickness of the first bone trabecular structure layer 12 is between 2mm and 6mm to facilitate integration of the femoral condyle bone prosthesis 1 with the femoral interface.
Preferably, the thickness of the second bone trabecular structural layer 22 is between 2mm and 6mm to facilitate integration of the tibial plateau prosthesis 2 with the tibial interface.
As shown in fig. 1, when both the femoral condyle prosthesis 1 and the tibial plateau prosthesis 2 are in use, the first bone trabecular structure layer 12 is disposed on a side of the first body 11 facing away from the tibial plateau prosthesis 2. Similarly, as shown in fig. 1 and 2, the second bone trabecular structure layer 22 is disposed on a side of the second body 21 facing away from the femoral condyle plateau prosthesis.
Preferably, the first body 11 further includes a plurality of first fixing piles disposed on a side of the first trabecular structure layer 12 of the first body 11, so as to improve the connection strength between the femoral condyle bone prosthesis 1 and the femur.
Preferably, the second body 21 further includes a plurality of second fixing piles disposed on one side of the second trabecular structure layer 22 of the second body 21, so as to improve the connection strength between the tibial plateau prosthesis 2 and the tibia.
In an embodiment, preferably, as shown in fig. 3-5, the unicondylar prosthesis system may further comprise a micro-texture 3 to increase the wear resistance of the unicondylar prosthesis system.
For a smooth friction interface of a prosthesis, the smoother the surface, the smaller the friction, and the surface micro-texture 3 has an important effect on reducing interface friction and abrasion. Along with the further development of bionics, the biological development method discovers that in the long-term evolution process, in order to adapt to the hard environment, special microstructures are formed on the body surface of the living pigeon, such as the skin texture of the feathers and sharks on the body surface of the living pigeon, the body surface scales of the desert lizard and the like, and the friction and abrasion of the contact surface can be effectively reduced. Microtexture 3 has proven to be an effective means of forming an anti-friction and anti-friction surface, and experimental tests have shown that a non-smooth surface of a regular shape in the kingdom has the effect of improving the lubrication state of the surface and anti-friction. The type, distribution, size of the surface microtexture 3 has a significant impact on the tribological properties of the friction pair. Under the lubrication condition, the reasonable surface micro-texture 3 is designed and processed, so that the friction performance of the friction pair can be effectively improved, and the effects of reducing drag and friction are achieved. The laser processing microstructure (the surface with the concave or convex shape arranged according to a certain rule) can not only keep a series of qualities of the implant material, so that the material itself is not changed, but also can greatly improve the comprehensive performance of the material. The lubrication state between artificial hip joint friction pairs is determined by the interaction of biomolecules in the joint fluid with the artificial joint, which is related to the wettability of the material. Wettability is the ability to characterize the spreading of a liquid on a solid surface, the hydrophilicity and hydrophobicity of a surface can be defined by the magnitude of the contact angle θ, when θ <90 °, the surface of the material is hydrophilic, whereas θ is greater than or equal to 90 °. Wettability affects wetting of the lubricating fluid at the hip joint surface and sliding characteristics of the interface, and for implantable biomaterials frictional wear of the implanted prosthesis contact interface will occur in physiological tissue fluids, the presence of microtexture 3 reduces frictional wear: (1) The micro pits can store abrasive dust generated in the friction process, and three-body abrasion which is extremely unfavorable to the friction process is avoided due to the fact that rough peaks and abrasive particles on the surfaces of the contact pairs are formed; (2) The joint liquid is stored, so that the friction pair is changed from a boundary lubrication state to a mixed lubrication state or even a fluid lubrication state; generating hydrodynamic pressure to enhance the bearing capacity of the lubricating film and improving the friction lubrication state; (3) The presence of the micro-texture 3 increases the bonding strength of the zirconium niobium alloy oxide layer.
Alternatively, as shown in fig. 3 to 5, the micro-texture 3 may be provided on the surface of the portion of the first body 11 where the first trabecular meshwork layer 12 is not provided. The surface of the portion of the first body 11 where the first bone trabecular structural layer 12 is not provided may be understood as a partial surface of the portion of the first body 11 where the first bone trabecular structural layer 12 is not provided, or may be understood as an entire surface of the portion of the first body 11 where the first bone trabecular structural layer 12 is not provided.
Alternatively, as shown in fig. 3 to 5, the micro-texture 3 may be provided on the surface of the portion of the second body 21 where the second trabecular meshwork layer 22 is not provided. Similar to the arrangement layout of the first body 11, the description thereof will be omitted.
Preferably, as shown in fig. 3 to 5, the micro texture 3 may include a plurality of micro crystal portions densely arranged. The microtexture 3 is provided on the surface of a certain structure, and the surface is understood to be densely packed with the microcrystalline portions.
Preferably, the micro-texture 3 is a nano-scale micro-texture 3. The nanoscale microtexture 3 is understood here to mean that the particle size and the distribution gap of the microtexture 3 are both nanoscale.
Preferably, the micro-texture 3 is a micro-scale micro-texture 3. The micro-scale micro-texture 3 is understood herein to mean that the grain size and the distribution gap of the micro-texture 3 are both micro-scale.
The micro-textures 3 provided on the surface of the first body 11 may be nano-sized micro-textures 3, or a mixture of nano-sized micro-textures 3 and micro-textures 3.
Preferably, as shown in fig. 4, the micro-texture 3 may be a convex portion, i.e., a structure protruding with respect to the surface of the first body 11 or the surface of the second body 21. Fig. 4 shows an example in which the cross section of the boss is a regular hexagon, but not limited thereto, the boss may be in the shape of an equal cross-sectional area or may be in the shape of an unequal cross-section. Among other shapes of the uniform cross-sectional area (i.e., columnar), the cross-sectional shape of the boss may be other shapes, such as circular, elliptical, polygonal, or other irregular patterns. In the shape of the unequal cross-sectional areas, the projections may also be hemispherical, semi-ellipsoidal, semi-polyhedral, pyramidal, or other irregular shapes.
Preferably, as shown in fig. 3 and 5, the micro-texture 3 may be a concave portion, i.e., a structure recessed with respect to the surface of the first body 11 or the surface of the second body 21. Fig. 3 shows an example in which the shape of the concave portion is cylindrical, and fig. 5 shows an example in which the shape of the concave portion is semi-ellipsoidal, however, the shape of the concave portion is similar to the shape of the convex portion described above, and will not be repeated.
Although the microcrystalline portions of the same form or shape are distributed on the surface of the first body 11 or the surface of the second body 21 in fig. 3 to 5, the present application is not limited thereto, and the microcrystalline portions of various structures and/or different forms may be distributed on the surface of the first body 11 or the surface of the second body 21 to form the micro-texture 3.
Preferably, the surface of the femoral condyle prosthesis 1 is coated with a metal ceramic layer, which may be coated on the surface of the micro-texture 3, the surface of the first bone trabecular structure layer 12, and the surface of the portion of the first body 11 where the micro-texture 3 and the first bone trabecular structure layer 12 are not disposed, so as to further enhance the wear resistance of the surface of the femoral condyle prosthesis 1.
Alternatively, the cermet layer may be formed via the surface oxidation treatment.
Similarly, the surface of the tibial plateau prosthesis 2 is coated with a cermet layer, and the distribution position and beneficial effects of the cermet layer are similar to those of the above-mentioned femoral condyle prosthesis 1, and will not be described again.
In this way, the surface of the femoral condyle prosthesis 1 and the surface of the tibial plateau prosthesis 2 are both covered by the integration of the cermet layer, ensuring the uniformity of the friction interface between the femoral condyle prosthesis 1 and the tibial plateau prosthesis 2, and ensuring the stability of the fit between the two and the overall wear resistance of the unicondylar prosthesis system.
Preferably, the thickness of the cermet layer is 3 μm to 35 μm to ensure wear resistance.
Preferably, the cermet layer includes an oxide layer and an oxygen-rich diffusion layer.
Compared with the prior art, the unicondylar prosthesis system provided by the technical characteristics has the following beneficial effects:
1. compared with the ultra-high molecular weight polyethylene liner in the prior art, the tibial plateau prosthesis 2 made of zirconium-niobium alloy can save more bone quantity of the tibial plateau and reserve more bone quantity for further repairing of patients;
2. the unicondylar prosthesis system made of the zirconium-niobium alloy effectively avoids the risk of prosthesis loosening caused by bone dissolution due to scraps generated by the abrasion of the ultra-high molecular weight polyethylene in the prior art;
3. the unicondylar prosthesis system is more wear-resistant through the superposition of the micro-texture 3 and the metal ceramic layer. The friction interface between the femoral condyle bone prosthesis 1 and the tibial plateau prosthesis 2 and the osseointegration interface (namely the first bone trabecular structure layer 12 and the second bone trabecular structure layer 22) realize functional integration through the metal ceramic layer, so that the long-term stability of the prosthesis is improved;
4. the 3D printing integrated prosthesis (namely the femoral condyle prosthesis 1 and the tibial plateau prosthesis 2) has magnesium and magnesium oxide in the first bone trabecular structural layer 12 and the second bone trabecular structural layer 22, so that the unicondylar prosthesis system can release magnesium ions in the use process, promote bone cell calcification, promote bone cell proliferation, inhibit inflammation, promote osteogenic differentiation and stimulate osteogenesis, is beneficial to the integration of the prosthesis and a bone interface, and improves the stability of the implanted prosthesis.
Finally, it should be noted that: the above embodiments are only for illustrating the technical solution of the present application, and not for limiting the same; although the application has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical scheme described in the foregoing embodiments can be modified or some or all of the technical features thereof can be replaced by equivalents; such modifications and substitutions do not depart from the spirit of the application.
Claims (10)
1. A method for manufacturing a unicondylar prosthesis system is characterized in that,
the unicondylar prosthesis system comprises a femoral condyle bone prosthesis and a tibial plateau prosthesis which are matched with each other;
the femoral condyle bone prosthesis comprises a first body and a first bone trabecular structure layer arranged on the first body, wherein the first bone trabecular structure layer is used for fusing with a femur;
the tibial plateau prosthesis comprises a second body and a second bone trabecular structure layer arranged on the second body, wherein the second bone trabecular structure layer is used for being fused with tibia;
wherein the method of manufacturing the unicondylar prosthesis system comprises the steps of:
3D printing and integrally forming, namely sequentially printing the first body and the first bone trabecular structure layer to form a first intermediate product of the femoral condyle bone prosthesis, and sequentially printing the second body and the second bone trabecular structure layer to form a first intermediate product of the tibial plateau prosthesis by using zirconium-niobium alloy powder as a raw material;
adding magnesium metal particles to the zirconium niobium alloy powder when printed to a first bone trabecular structure layer of the femoral condyle bone prosthesis and when printed to a second bone trabecular structure layer of the tibial plateau prosthesis;
heat treating, respectively, the first intermediate product of the femoral condyle prosthesis and the first intermediate product of the tibial plateau prosthesis;
machining and shaping, namely respectively and sequentially carrying out machining and trimming treatment, polishing treatment, cleaning treatment and drying treatment on the femoral condyle prosthesis and the tibial plateau prosthesis after the heat treatment step;
and (3) carrying out surface oxidation treatment, namely respectively placing the femoral condyle prosthesis and the tibial plateau prosthesis which are subjected to the machining shaping step in a tube furnace, introducing normal-pressure inert gas with the oxygen content of 5-15% by mass, heating to 500-700 ℃ at 5-20 ℃/min, cooling to 400-495 ℃ at 0.4-0.9 ℃/min, naturally cooling to below 200 ℃, and taking out.
2. The method of manufacturing a unicondylar prosthesis system of claim 1, wherein,
the grain size of the zirconium niobium alloy powder is 5-150 mu m;
the particle diameter of the magnesium metal particles is 5-10 mu m.
3. The method of manufacturing a unicondylar prosthesis system of claim 1, wherein the magnesium metal particles are added in an amount of 1% -5% by volume of the zirconium niobium alloy powder.
4. The method of manufacturing a unicondylar prosthetic system of claim 1, wherein the heat treating step comprises:
step one, obtaining a first intermediate product of the femoral condyle prosthesis and the tibial plateau prosthesis through 3D printing and integrally forming, putting the first intermediate product into a hot isostatic pressing furnace, heating to 1250-1400 ℃ under the protection of helium or argon, placing the first intermediate product at a constant temperature of 140-180 MPa for 1-3 h, cooling to below 200 ℃ along with the furnace, and taking out the second intermediate product of the femoral condyle prosthesis and the tibial plateau prosthesis;
step two, placing a second intermediate product of the femoral condyle prosthesis and the tibial plateau prosthesis in a procedural cooling box, cooling to-80 ℃ to-120 ℃ at a speed of 1 ℃/min, placing at constant temperature for 5-10 h, and taking out from the procedural cooling box; placing the femoral condyle prosthesis and the tibial plateau prosthesis in liquid nitrogen for 16-36 h again, and regulating the temperature to room temperature to obtain a third intermediate product of the femoral condyle prosthesis and the tibial plateau prosthesis;
step three, placing a third intermediate product of the femoral condyle prosthesis and the tibial plateau prosthesis in a procedural cooling box, cooling to-80 ℃ to-120 ℃ at a speed of 1 ℃/min, and placing at constant temperature for 5-10 h; taking out from the procedural cooling box; placing in liquid nitrogen for 16-36 h, and regulating the temperature to room temperature; a fourth intermediate product of both the femoral condyle prosthesis and the tibial plateau prosthesis is obtained.
5. The method of manufacturing a unicondylar prosthesis system of claim 1, wherein in the machining sizing step, the machining finishing process further comprises micro-texturing a surface of the first body and/or the second body using a high precision machining apparatus.
6. A unicondylar prosthesis system comprising a femoral condyle bone prosthesis and a tibial plateau prosthesis mated to each other;
the femoral condyle bone prosthesis comprises a first body and a first bone trabecular structure layer arranged on the first body, wherein the first bone trabecular structure layer is used for fusing with a femur;
the tibial plateau prosthesis comprises a second body and a second bone trabecular structure layer arranged on the second body, the second bone trabecular structure layer is used for fusing with tibia,
the first body and the first bone trabecular structure layer are integrally formed through 3D printing of zirconium-niobium alloy powder;
the second body and the second bone trabecular structure layer are integrally formed through 3D printing of zirconium-niobium alloy powder.
7. The unicondylar prosthesis system of claim 6, wherein,
the thickness of the first bone trabecular structure layer is 2 mm-6 mm;
the thickness of the second bone trabecular structure layer is 2 mm-6 mm.
8. The unicondylar prosthesis system of claim 6, further comprising a microtexture;
the micro-texture is arranged on the surface of the part of the first body where the first bone trabecular structure layer is not arranged, and/or
The micro-texture is disposed on a surface of a portion of the second body where the second bone trabecular structure layer is not disposed.
9. The unicondylar prosthesis system of claim 8, wherein,
the micro-texture comprises a plurality of microcrystal parts which are densely arranged;
the micro-texture is nano-scale micro-texture and/or micro-scale micro-texture;
the microcrystal part is a protruding part or a recessed part.
10. The unicondylar prosthesis system of claim 6, wherein surfaces of both the femoral condyle prosthesis and the tibial plateau prosthesis are coated with a cermet layer.
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| CN202310938948.0A CN116919668A (en) | 2023-07-28 | 2023-07-28 | Method for manufacturing a unicondylar prosthesis system and unicondylar prosthesis system |
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| CN202310938948.0A CN116919668A (en) | 2023-07-28 | 2023-07-28 | Method for manufacturing a unicondylar prosthesis system and unicondylar prosthesis system |
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