CN112155802A - Cobalt alloy tibial plateau prosthesis with trabecula and preparation method - Google Patents

Cobalt alloy tibial plateau prosthesis with trabecula and preparation method Download PDF

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Publication number
CN112155802A
CN112155802A CN202011191059.5A CN202011191059A CN112155802A CN 112155802 A CN112155802 A CN 112155802A CN 202011191059 A CN202011191059 A CN 202011191059A CN 112155802 A CN112155802 A CN 112155802A
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Prior art keywords
cobalt alloy
bone
trabecular
porosity
tibial plateau
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李建宇
尹方
赵朝盛
刘璐
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Jiast Huajian Medical Equipment Tianjin Co ltd
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Jiast Huajian Medical Equipment Tianjin Co ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/38Joints for elbows or knees
    • A61F2/389Tibial components
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/3094Designing or manufacturing processes
    • A61F2/30942Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B22CASTING; POWDER METALLURGY
    • B22FWORKING METALLIC POWDER; MANUFACTURE OF ARTICLES FROM METALLIC POWDER; MAKING METALLIC POWDER; APPARATUS OR DEVICES SPECIALLY ADAPTED FOR METALLIC POWDER
    • B22F5/00Manufacture of workpieces or articles from metallic powder characterised by the special shape of the product
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B33ADDITIVE MANUFACTURING TECHNOLOGY
    • B33YADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y10/00Processes of additive manufacturing
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B33ADDITIVE MANUFACTURING TECHNOLOGY
    • B33YADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y70/00Materials specially adapted for additive manufacturing
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B33ADDITIVE MANUFACTURING TECHNOLOGY
    • B33YADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y80/00Products made by additive manufacturing
    • CCHEMISTRY; METALLURGY
    • C22METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
    • C22CALLOYS
    • C22C19/00Alloys based on nickel or cobalt
    • C22C19/07Alloys based on nickel or cobalt based on cobalt
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/30004Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
    • A61F2002/30011Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis differing in porosity
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006Properties of materials and coating materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/3094Designing or manufacturing processes
    • A61F2002/30985Designing or manufacturing processes using three dimensional printing [3DP]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005The prosthesis being constructed from a particular material
    • A61F2310/00011Metals or alloys
    • A61F2310/00029Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Manufacturing & Machinery (AREA)
  • Materials Engineering (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Cardiology (AREA)
  • Public Health (AREA)
  • Transplantation (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)
  • Oral & Maxillofacial Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Mechanical Engineering (AREA)
  • Geometry (AREA)
  • Physics & Mathematics (AREA)
  • Metallurgy (AREA)
  • Organic Chemistry (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Prostheses (AREA)

Abstract

The invention discloses a cobalt alloy tibial plateau prosthesis with trabecular bone and a preparation method thereof, wherein the cobalt alloy tibial plateau prosthesis with trabecular bone takes cobalt alloy powder as raw material, a first intermediate product of the cobalt alloy tibial plateau prosthesis with trabecular bone is obtained by 3D printing and integral molding, the tibial plateau prosthesis comprising a near plateau joist layer and a far plateau joist layer is prepared by hot isostatic pressing and deep cooling processes, the aperture and porosity of the near plateau joist layer are uniformly arranged, and the aperture and porosity of the far plateau joist layer are arranged in a partition way. The mechanical adaptability of the prosthesis is improved, and the prosthesis has excellent bone ingrowth property.

Description

Cobalt alloy tibial plateau prosthesis with trabecula and preparation method
Technical Field
The invention relates to the technical field of medical implant materials, in particular to a cobalt alloy tibial plateau prosthesis with a trabecular bone and a preparation method thereof.
Background
Total knee replacement is currently an effective treatment mode for end-stage knee joint diseases in clinic, and the damaged knee joint tissue is replaced by an artificially designed joint prosthesis, so that pain of patients is relieved, the knee joint function of the patients is recovered, and the life quality of the patients is improved. Corresponding to the anatomical structure of human body, the knee joint prosthesis comprises a femoral condyle, a tibial plateau and a platform pad. With the rapid development of medical instrument technology and the continuous improvement of requirements of people on the safety and effectiveness of prosthesis products, the design and manufacturing technology of knee joint prostheses needs to be continuously optimized and improved.
Currently, clinically used knee prostheses include two major classes, bone cement type and biologic type (non-bone cement fixation). Wherein the bone cement type prosthesis mechanically fixes the joint prosthesis and the bone tissue by means of the solidification and filling of the bone cement. However, years of clinical application show that bone cement fixation can bring about a plurality of safety and effectiveness problems: the bone cement monomer is polymerized to release heat, so that surrounding tissues are damaged; bone cement particles, if introduced into the blood or during filling, cause high pressure in the medullary cavity, leading to pulmonary embolism and fat embolism.
The biological knee joint prosthesis can effectively eliminate the safety and effectiveness risks brought by bone cement, and generally utilizes a surface porous structure to promote bone ingrowth so as to obtain long-term stability. But the surface porous structure is usually prepared by surface treatment processes such as sand blasting, coating, sintering and the like, has low bonding strength with an entity, is easy to fall off, and reduces the service life of the prosthesis. In addition, effective bone ingrowth cannot be realized by the porous structures, and the clinical reports that only 2% -40% of bones of the tibial plateau of the artificial knee joint grow into the tibial plateau, so that powerful biological fixation cannot be formed.
Patent CN109938888A has subregion bone trabecula structure tibial plateau through EBM electron beam melting technique 3D printing, and under human lower limbs force line skew, under the uneven condition of horizontal direction atress, through discontinuous medium to the transmissibility of force different, design different horizontal direction bone trabecula subregion topological structure for tibial plateau bone interface stress/strain is homogeneous, thereby realizes that even bone grows into. However, when the platform/bone interface is viewed axially, stress shielding occurs between the high elastic modulus of the metal material of the prosthesis and the low elastic modulus of the bone tissue. According to Wolff's law: the stress can only initiate the original signal to regulate the synthesis and catabolism of bone after the bone is deformed (also called micro-strain), and the strain range can only promote the bone growth between the minimum effective strain threshold and the supraphysiological strain threshold. Therefore, the trabecular bone interface layer of the knee joint tibial platform is designed, the topological structure is optimized, stress shielding is greatly reduced, micro strain of most areas of bone tissues is between the minimum effective strain threshold and the supraphysiological strain threshold, osseointegration is facilitated, and the method has important significance.
The 3D printing technology is used as an additive manufacturing technology, breaks through a product design concept facing a manufacturing process, realizes a product design concept facing performance, solves the problem that complex parts are difficult to integrally form, and reduces waste of raw materials and energy caused by machining and manufacturing. However, the solid part of the 3D printed product is easy to have the problems of uneven microstructure, internal defects and the like, and the mechanical property is poor; the powder in the trabecular bone part structure cannot be well sintered, and the mechanical property is poor. Therefore, the preparation of the cobalt alloy tibial plateau prosthesis with the trabecula bone with excellent mechanical property and osseointegration property has important significance.
Disclosure of Invention
The invention aims to overcome the defects of the prior art and provides a cobalt alloy tibial plateau prosthesis with trabecular bone.
A second object of the present invention is to provide a method of making a cobalt alloy tibial plateau prosthesis with trabeculae.
The technical scheme of the invention is summarized as follows:
the preparation method of the cobalt alloy tibial plateau prosthesis with the trabecular bone comprises the following steps:
1) taking cobalt alloy powder as a raw material, carrying out 3D printing and integral forming to obtain a first intermediate product of the cobalt alloy tibial plateau prosthesis with the trabecula bone, putting the first intermediate product into a hot isostatic pressing furnace, heating to 1140-1200 ℃ under the protection of helium or argon, standing for 1-3 h at a constant temperature of 110-170 MPa, reducing to normal pressure, cooling to below 200 ℃ along with the furnace, and taking out to obtain a second intermediate product:
2) placing the second intermediate product in a programmed cooling box, cooling to-80-120 ℃ at the speed of 1 ℃/min, placing at constant temperature for 5-10 h, and taking out from the programmed cooling box; placing the mixture in liquid nitrogen for 16-36 h, and adjusting the temperature to room temperature to obtain a third intermediate product;
3) placing the third intermediate product in a programmed cooling box, cooling to-80 to-120 ℃ at the speed of 1 ℃/min, and placing for 5 to 10 hours at constant temperature; taking out the box from the programmed cooling box; placing in liquid nitrogen for 16-36 h, and adjusting the temperature to room temperature; obtaining a fourth intermediate product, and performing machining and trimming to obtain a cobalt alloy tibial plateau prosthesis with trabeculae;
the first intermediate product, the second intermediate product, the third intermediate product and the fourth intermediate product of the cobalt alloy tibial plateau prosthesis with the trabecular bone have the same structure as the cobalt alloy tibial plateau prosthesis with the trabecular bone;
the cobalt alloy tibial plateau prosthesis with the trabecula comprises a kidney-shaped platform support 1, wherein a dovetail-shaped bump 3 is arranged on the upper surface of a bent part in the kidney-shaped platform support, rear grooves 5 are arranged on the outer side surfaces of two oblique branches of the dovetail-shaped bump 3, an arc-shaped bump 2 is arranged on the kidney-shaped platform support 1 and the upper surface of the bent part opposite to the dovetail-shaped bump 3, a front groove 6 is arranged on the inner side surface of the arc-shaped bump 2, a handle 4 is arranged in the middle of the lower surface of the kidney-shaped platform support, trabecula 9 is arranged on the lower surface of the kidney-shaped platform support except for the connecting handle 4, and the trabecula 9 consists of a near platform trabecula layer 21 and a far platform trabecula layer 20; the aperture and porosity of the near platform joist layer 21 are uniformly arranged, and the far platform joist layer is arranged in a three-partition manner; the transverse diameter 10 corresponding to the kidney-shaped platform support is divided into a first section 25, a second section 26 and a third section 27 by a first marking point 11 and a second marking point 12, the length of the first section, the second section and the third section is 25% -38% of the transverse diameter of the kidney-shaped platform support, 24% -50% and 25% -38% of the transverse diameter of the kidney-shaped platform support, a first partition line 13 is first marking point 11, and a second partition line 14 is second marking point 12; the first division line 13 and the second division line 14 are straight lines or arc lines, and divide the far platform joist trabecular layer 20 of the corresponding kidney-shaped platform support into an inner area 15, a middle area 16 and an outer area 17; the pore size and porosity of the trabeculae in the medial region 15 are in turn greater than those in the lateral region 17 and the medial region 16.
The cobalt alloy powder comprises 59-68% of Co, 26.5-30.0% of Cr, 4.5-7.0% of Mo and the balance of inevitable trace impurities by mass percent; the particle size of the cobalt alloy powder is 45-106 μm.
The steps 2) and 3) of adjusting the temperature are as follows: heating to-120 to-80 ℃, and keeping the temperature for 3 to 5 hours; heating to-40 to-20 ℃, and keeping the temperature for 3 to 5 hours; heating to 4-8 deg.c, maintaining for 1-3 hr, and heating.
Preferably, the aperture of the trabecular bone of the near-platform joist trabecular bone layer 21 is 0.36-0.50 mm, the porosity is 55-65%, and the through porosity is 100%; the thickness of the near-platform bone supporting trabecular layer (21) is 0.2mm-1 mm.
When the first partition line 13 and the second partition line 14 of the far platform joist trabecula layer 20 are straight lines, the first partition line and the second partition line are arranged in parallel or in a splayed shape; the degree of an included angle 18 between the first partition line 13) and the transverse diameter 10 of the kidney-shaped platform support is 100-60 degrees, and the degree of an included angle 19 between the second partition line 14 and the transverse diameter 10 of the kidney-shaped platform support is 80-120 degrees.
The aperture of the trabecular bone in the inner side area of the far platform joist trabecular layer 20 is 1.00mm-1.10mm, the porosity is 77.6% -85%, and the through porosity is 100%; the aperture of the trabecula bone in the middle area is 0.74mm-0.85mm, the porosity is 70.0% -74.7%, and the through porosity is 100%; the aperture of the trabecular bone in the lateral area is 0.86mm-0.99mm, the porosity is 74.8% -77.5%, and the through porosity is 100%; the thickness of the far platform joist trabecula layer 20 is 0.5-3 mm.
The handle is a reducer pipe connected with the supporting plate, a reducer pipe connected with the supporting plate and with a closed bottom, a cross-shaped rib plate or a bent cross-shaped rib plate.
The cobalt alloy tibial plateau prosthesis with the trabecular bone prepared by the method.
The invention has the advantages that:
the trabecular bone topological structure of the cobalt alloy tibial plateau prosthesis with the trabecular bone is distributed in a gradient mode from three dimensions, so that the bonding strength of the trabecular bone of the tibial plateau and a solid body can be improved, the micro-strain of 64% -72% of a finite element model of a tibial plateau bone tissue is between a minimum effective strain threshold value and an ultra-physiological strain threshold value, the mechanical adaptability of the prosthesis is improved, and the cobalt alloy tibial plateau prosthesis has excellent bone growth performance. The invention adopts 3D printing and integrated molding, has high bonding strength between the trabecula bone and the solid body, is not easy to fall off, and prolongs the service life of the prosthesis.
The trabecular bone part of the tibial plateau prosthesis prepared by the invention has excellent compression resistance; the solid part releases residual stress and plasticity is enhanced.
Drawings
FIG. 1 is an isometric view of a cobalt alloy tibial plateau prosthesis (with a curved cruciform rib plate as the stem) with trabeculae according to the present invention.
Fig. 2 is a schematic view of the bone trabecular zone division of the lower surface of the cobalt alloy tibial plateau prosthesis with trabecular bone according to the present invention.
Fig. 3 is a bottom view of the cobalt alloy tibial plateau prosthesis with trabecular bone (the stem is a curved cross-shaped rib plate) of the present invention.
Fig. 4 is a bottom view of the cobalt alloy tibial plateau prosthesis with trabecular bone of the present invention (first zone line 13 and second zone line 14 are arcs).
Fig. 5 is a bottom view of the cobalt alloy tibial plateau prosthesis with trabecular bone of the present invention (the first partition line 13 and the second partition line 14 are arranged in a straight line in a figure-of-eight configuration).
Fig. 6 is an isometric view of a cobalt alloy tibial plateau prosthesis with trabecular bone (stem being a closed-bottomed reducer) of the present invention.
Fig. 7 is an isometric view of a cobalt alloy tibial plateau prosthesis with trabecular bone of the present invention (with the stem partially cut away from the base-closed reducer, kidney plateau and trabecular layer).
Fig. 8 is an isometric view of a cobalt alloy tibial plateau prosthesis with trabecular bone (stem being a closed-bottomed reducer with a buttress plate attached) of the present invention (excluding the distal plateau trabecular bone layer).
Fig. 9 is an isometric view of a cobalt alloy tibial plateau prosthesis with trabecular bone (stem being a reducer with a buttress plate attached) of the present invention.
Fig. 10 is a strain cloud diagram for finite element analysis of the cobalt alloy tibial plateau prosthesis with trabecular bone (the stem is a curved cross-shaped rib) of example 1 with the first section line 13 and the second section line 14 being straight and parallel and having an angle of 90 degrees with the transverse diameter (the length of the tibial plateau).
Fig. 11 is a strain cloud graph of splayed finite element analysis with the first partition line 13 and the second partition line 14 being straight lines for the cobalt alloy tibial plateau prosthesis with trabecular bone (stem is a reducer with a closed bottom to which a buttress plate is attached) of example 2.
Fig. 12 is a strain cloud of the cobalt alloy tibial plateau prosthesis with trabecular bone of example 3 (stem is a closed-bottomed reducer with buttress plate attached) first partition line 13 and second partition line 14 in arc finite element analysis.
Fig. 13 is a trabecular SEM image of control 1.
Fig. 14 is a trabecular SEM image of example 1.
Fig. 15 is a metallographic micrograph of the tibial plateau prosthesis of control 1.
Fig. 16 is a metallographic micrograph of the cobalt alloy tibial plateau prosthesis with trabeculae according to example 1.
Fig. 17 is an equivalent stress cloud chart of the cobalt alloy tibial plateau prosthesis with trabecular bone (with the shank being a curved cross-shaped rib) of example 1, in which the first section line 13 and the second section line 14 are straight lines and parallel and form an angle of 90 degrees with the transverse diameter (the length of the tibial plateau).
Detailed Description
The present invention will be further illustrated by the following specific examples.
Example 1
The preparation method of the cobalt alloy tibial plateau prosthesis with the trabecular bone comprises the following steps:
1) taking cobalt alloy powder as a raw material, carrying out 3D printing and integral forming to obtain a first intermediate product of the cobalt alloy tibial plateau prosthesis with the trabecula bone, putting the first intermediate product into a hot isostatic pressing furnace, heating to 1140 ℃ under the protection of argon, standing at the constant temperature of 170MPa for 3h, reducing the temperature to normal pressure, cooling to below 200 ℃ along with the furnace, taking out to obtain a second intermediate product:
2) placing the second intermediate product in a programmed cooling box, cooling to-80 ℃ at the speed of 1 ℃/min, placing at constant temperature for 10h, and taking out from the programmed cooling box; placing in liquid nitrogen for 16h, and adjusting the temperature to room temperature to obtain a third intermediate product;
3) placing the third intermediate product in a programmed cooling box, cooling to-80 ℃ at the speed of 1 ℃/min, and placing for 10h at constant temperature; taking out the box from the programmed cooling box; placing in liquid nitrogen for 16h, and adjusting the temperature to room temperature; and obtaining a fourth intermediate product, and performing machining trimming to obtain the cobalt alloy tibial plateau prosthesis with the trabecula.
The first intermediate product, the second intermediate product, the third intermediate product and the fourth intermediate product of the cobalt alloy tibial plateau prosthesis with the trabecular bone have the same structure as the cobalt alloy tibial plateau prosthesis with the trabecular bone.
The cobalt alloy tibial plateau prosthesis with the trabecular bone (see figure 1) comprises a kidney-shaped platform support 1, wherein a dovetail-shaped lug 3 is arranged on the upper surface of a bent part in the kidney-shaped platform support, rear grooves 5 are arranged on the outer side surfaces of two oblique branches of the dovetail-shaped lug 3, an arc-shaped lug 2 is arranged on the kidney-shaped platform support 1 and the upper surface of the bent part which is outward relative to the dovetail-shaped lug 3, a front groove 6 is arranged on the inner side surface of the arc-shaped lug 2, a handle 4 is arranged in the middle of the lower surface of the kidney-shaped platform support, the trabecular bone 9 is arranged on the lower surface of the kidney-shaped platform support except for the connecting handle 4, and the trabecular bone 9 consists of a near platform trabecular bone layer 21 and a far platform trabecular bone layer 20 (see figure 7); the aperture and porosity of the near platform joist layer 21 (shown in figure 8) are uniformly arranged, and the far platform joist layer is arranged in a three-partition manner; the transverse diameter 10 corresponding to the kidney-shaped platform support is divided into a first section 25, a second section 26 and a third section 27 by a first marking point 11 and a second marking point 12, the length of the first section, the length of the second section and the length of the third section are respectively 30 percent, 40 percent and 30 percent of the transverse diameter of the kidney-shaped platform support, a first partition line 13 is first marking point 11, and a second partition line 14 is second marking point 12; the first partition line 13 and the second partition line 14 are straight lines and divide the distal plateau trabecular lamina 20 of the corresponding kidney plateau tray into an inner zone 15, an intermediate zone 16 and an outer zone 17 (see fig. 2); the pore size and porosity of the trabeculae in the medial region 15 are in turn greater than those in the lateral region 17 and the medial region 16.
The cobalt alloy powder comprises 68% of Co, 26.5% of Cr, 4.5% of Mo and the balance of inevitable trace impurities by mass percent; the cobalt alloy powder had a particle size of 45 μm to 106 μm and was purchased from Acram, Sweden.
The temperature adjusting step comprises: heating to-120 deg.C, and maintaining at constant temperature for 5 hr; heating to-40 deg.C, and maintaining at constant temperature for 5 hr; heating to 4 deg.C, maintaining at constant temperature for 3 hr, and heating.
The aperture of the trabecular bone of the near-platform trabecular bone supporting layer 21 is 0.43mm, the porosity is 60 percent, and the through porosity is 100 percent; the thickness of the near-platform joist trabecular layer 21 is 0.6 mm.
The first partition line 13 and the second partition line 14 of the far platform joist trabecular layer 20 are arranged in parallel when being straight lines; the angle 18 between the first section line 13 and the transverse diameter 10 of the kidney shaped platform support is 90 degrees, and the angle 19 between the second section line 14 and the transverse diameter 10 of the kidney shaped platform support is 90 degrees (fig. 3).
The aperture of the trabecular bone in the inner side area of the far platform joist trabecular layer 20 is 1.05mm, the porosity is 80 percent, and the through porosity is 100 percent; the aperture of the trabecula bone in the middle area is 0.80mm, the porosity is 72 percent, and the through porosity is 100 percent; the aperture of the trabecular bone in the outer area is 0.90mm, the porosity is 75 percent, and the through porosity is 100 percent; the thickness of the far platform joist trabecula layer 20 is 2 mm.
The handle is a bent cross-shaped rib plate. (see FIG. 3)
The finite element analysis strain cloud of this example is shown in FIG. 10.
Side walls 22 may also be provided at the edges of the lower surface of the kidney shaped platform support so that the trabecular bone layer is disposed inwardly of the side walls.
Example 2
The preparation method of the cobalt alloy tibial plateau prosthesis with the trabecular bone comprises the following steps:
1) taking cobalt alloy powder as a raw material, carrying out 3D printing and integral forming to obtain a first intermediate product of the cobalt alloy tibial plateau prosthesis with the trabecula bone, putting the first intermediate product into a hot isostatic pressing furnace, heating to 1170 ℃ under the protection of argon, standing at a constant temperature of 140MPa for 2h, reducing the temperature to normal pressure, cooling to below 200 ℃ along with the furnace, taking out to obtain a second intermediate product:
2) placing the second intermediate product in a programmed cooling box, cooling to-100 ℃ at the speed of 1 ℃/min, placing at constant temperature for 7h, and taking out from the programmed cooling box; placing in liquid nitrogen for 24h again, and adjusting the temperature to room temperature to obtain a third intermediate product;
3) placing the third intermediate product in a programmed cooling box, cooling to-100 ℃ at the speed of 1 ℃/min, and placing for 7h at constant temperature; taking out the box from the programmed cooling box; placing in liquid nitrogen for 24h, and adjusting the temperature to room temperature; obtaining a fourth intermediate product, and performing machining trimming to obtain a cobalt alloy tibial plateau prosthesis with trabeculae;
the first intermediate product, the second intermediate product, the third intermediate product and the fourth intermediate product of the cobalt alloy tibial plateau prosthesis with the trabecular bone have the same structure as the cobalt alloy tibial plateau prosthesis with the trabecular bone;
the cobalt alloy tibial plateau prosthesis with trabecula (see figure 9) comprises a kidney-shaped platform support 1, wherein a dovetail-shaped convex block 3 is arranged on the upper surface of a bent part in the kidney-shaped platform support, rear grooves 5 are arranged on the outer side surfaces of two oblique branches of the dovetail-shaped convex block 3, an arc-shaped convex block 2 is arranged on the kidney-shaped platform support 1 and the upper surface of the bent part which is outward relative to the dovetail-shaped convex block 3, a front groove 6 is arranged on the inner side surface of the arc-shaped convex block 2, a handle 4 is arranged in the middle of the lower surface of the kidney-shaped platform support, trabecula 9 is arranged on the lower surface of the kidney-shaped platform support except for the connecting handle 4, and the trabecula 9 consists of a near platform trabecula layer 21 and a far platform trabecula layer 20; the aperture and porosity of the near platform joist layer 21 are uniformly arranged, and the far platform joist layer is arranged in a three-partition manner; the transverse diameter 10 corresponding to the kidney-shaped platform support is divided into a first section 25, a second section 26 and a third section 27 by a first marking point 11 and a second marking point 12, the length of the first section, the length of the second section and the length of the third section are respectively 38 percent, 24 percent, 38 percent, the first section line 13 is the first marking point 11, and the second section line 14 is the second marking point 12; the first partition line 13 and the second partition line 14 are straight lines and divide the far platform joist trabecular layer 20 of the corresponding kidney-shaped platform support into an inner region 15, a middle region 16 and an outer region 17; the pore size and porosity of the trabeculae in the medial region 15 are in turn greater than those in the lateral region 17 and the medial region 16.
The cobalt alloy powder comprises 59 mass percent of Co, 30.0 mass percent of Cr, 7.0 mass percent of Mo and the balance of inevitable trace impurities; the cobalt alloy powder had a particle size of 45 μm to 106 μm and was purchased from Acram, Sweden.
The temperature adjusting step comprises: heating to-100 deg.C, and maintaining at constant temperature for 4 hr; heating to-30 deg.C, and maintaining at constant temperature for 4 hr; heating to 6 deg.C, maintaining at constant temperature for 2h, and heating.
The aperture of the trabecular bone of the near-platform trabecular bone supporting layer 21 is 0.50mm, the porosity is 65%, and the through porosity is 100%; the thickness of the near-platform joist trabecula layer 21 is 1 mm.
The first partition line 13 and the second partition line 14 of the far platform joist trabecula layer 20 are arranged in a splayed shape when being straight; the angle 18 between the first section line 13 and the transverse diameter 10 of the kidney shaped platform support is 100 degrees, and the angle 19 between the second section line 14 and the transverse diameter 10 of the kidney shaped platform support is 80 degrees (apart from the handle, the trabecular layer of the distal platform support bone is shown in fig. 5).
(alternatively, the included angle 18 between the first section line 13 and the transverse diameter 10 of the kidney-shaped platform support is 60 degrees, and the included angle 19 between the second section line 14 and the transverse diameter 10 of the kidney-shaped platform support is 120 degrees.)
The aperture of the trabecular bone in the inner side area of the far platform joist trabecular layer 20 is 1.10mm, the porosity is 85 percent, and the through porosity is 100 percent; the aperture of the trabecula bone in the middle area is 0.85mm, the porosity is 74.7 percent, and the through porosity is 100 percent; the aperture of the trabecular bone in the outer area is 0.99mm, the porosity is 77.5 percent, and the through porosity is 100 percent; the thickness of the far platform joist trabecula layer 20 is 0.5 mm.
The handle is a reducer pipe with a bottom connected with a supporting plate and a closed bottom. (handle see FIG. 6)
The finite element analysis strain cloud of this example is shown in FIG. 11.
Side walls 22 may also be provided at the edges of the lower surface of the kidney shaped platform support so that the trabecular bone layer is disposed inwardly of the side walls.
Example 3
The preparation method of the cobalt alloy tibial plateau prosthesis with the trabecular bone comprises the following steps:
1) taking cobalt alloy powder as a raw material, carrying out 3D printing and integral forming to obtain a first intermediate product of the cobalt alloy tibial plateau prosthesis with the trabecula bone, putting the first intermediate product into a hot isostatic pressing furnace, heating to 1200 ℃ under the protection of helium, standing at a constant temperature of 110MPa for 1h, reducing the temperature to normal pressure, cooling to below 200 ℃ along with the furnace, taking out to obtain a second intermediate product:
2) placing the second intermediate product in a programmed cooling box, cooling to-120 ℃ at the speed of 1 ℃/min, placing at constant temperature for 5h, and taking out from the programmed cooling box; placing in liquid nitrogen for 36h, and adjusting the temperature to room temperature to obtain a third intermediate product;
3) placing the third intermediate product in a programmed cooling box, cooling to-120 ℃ at the speed of 1 ℃/min, and placing for 5h at constant temperature; taking out the box from the programmed cooling box; placing in liquid nitrogen for 36h, and adjusting the temperature to room temperature; obtaining a fourth intermediate product, and performing machining trimming to obtain a cobalt alloy tibial plateau prosthesis with trabeculae;
the first intermediate product, the second intermediate product, the third intermediate product and the fourth intermediate product of the cobalt alloy tibial plateau prosthesis with the trabecular bone have the same structure as the cobalt alloy tibial plateau prosthesis with the trabecular bone;
the cobalt alloy tibial plateau prosthesis with trabecula comprises a kidney-shaped platform support 1, wherein a dovetail-shaped bump 3 is arranged on the upper surface of a bent part in the kidney-shaped platform support, rear grooves 5 are arranged on the outer side surfaces of two oblique branches of the dovetail-shaped bump 3, an arc-shaped bump 2 is arranged on the kidney-shaped platform support 1 and the upper surface of the bent part opposite to the dovetail-shaped bump 3, a front groove 6 is arranged on the inner side surface of the arc-shaped bump 2, a handle 4 is arranged in the middle of the lower surface of the kidney-shaped platform support, trabecula 9 is arranged on the lower surface of the kidney-shaped platform support except for the connecting handle 4, and the trabecula 9 consists of a near platform trabecula layer 21 and a far platform trabecula layer 20; the aperture and porosity of the near platform joist layer 21 are uniformly arranged, and the far platform joist layer is arranged in a three-partition manner; the transverse diameter 10 corresponding to the kidney-shaped platform support is divided into a first section 25, a second section 26 and a third section 27 by a first marking point 11 and a second marking point 12, the length of the first section, the length of the second section and the length of the third section are 25% -50% -25% of the transverse diameter of the kidney-shaped platform support, the length of the first section, the length of the second section and the length of the third section are 25%, the length of the first section, the length of the second section; the first division line 13 and the second division line 14 are arcs (see fig. 4) and divide the distal plateau trabecular layer 20 of the corresponding kidney plateau tray into an inner zone 15, a middle zone 16 and an outer zone 17; the pore size and porosity of the trabeculae in the medial region 15 are in turn greater than those in the lateral region 17 and the medial region 16.
The cobalt alloy powder comprises 64% of Co, 28.5% of Cr, 6% of Mo and the balance of inevitable trace impurities by mass percent; the cobalt alloy powder had a particle size of 45 μm to 106 μm and was purchased from Acram, Sweden.
The temperature adjusting step comprises: heating to-80 deg.C, and maintaining at constant temperature for 3 hr; heating to-20 deg.C, and maintaining at constant temperature for 3 hr; heating to 8 deg.C, maintaining at constant temperature for 1h, and heating.
The aperture of the trabecular bone of the near-platform trabecular bone supporting layer (21) is 0.36mm, the porosity is 55%, and the through porosity is 100%; the thickness of the near-platform bone supporting trabecular layer (21) is 0.2 mm.
The aperture of the trabecular bone in the inner side area of the far platform trabecular bone supporting layer (20) is 1.00mm, the porosity is 77.6%, and the through porosity is 100%; the aperture of the trabecula bone in the middle area is 0.74mm, the porosity is 70.0 percent, and the through porosity is 100 percent; the aperture of the trabecular bone in the lateral area is 0.86mm, the porosity is 74.8 percent, and the through porosity is 100 percent; the thickness of the far platform bone supporting trabecula layer (20) is 3 mm.
The handle is a reducer pipe with a bottom connected with a supporting plate and a closed bottom.
The strain cloud of the finite element analysis of this example is shown in FIG. 12.
Side walls 22 may also be provided at the edges of the lower surface of the kidney shaped platform support so that the trabecular bone layer is disposed inwardly of the side walls.
Control group 1
The preparation method of the tibial plateau prosthesis (without hot isostatic pressing and deep cooling) comprises the steps of taking cobalt alloy powder (same as example 1) as a raw material, and carrying out 3D printing, integral forming and machining finishing to obtain the cobalt alloy tibial plateau prosthesis with the trabecular bone. The structure is the same as example 1.
Experiments prove that
Finite element analysis is carried out on the finite element models of the embodiments 1, 2 and 3, the obtained finite element analysis strain cloud chart only shows the micro strain (shaded part) in the range of 1000-3000, the occupation ratios of the 1000-3000 micro strain area on the finite element model of the tibial plateau bone tissue in the whole tibial plateau bone tissue finite element model are 65.6%, 64.4% and 68.1% respectively (fig. 10, 11 and 12), which indicates that the cobalt alloy tibial plateau prosthesis with the trabecular bone can realize that the micro strain of most areas of the bone tissue is between the minimum effective strain threshold value and the supraphysiological strain threshold value, and is beneficial to bone ingrowth.
The trabecular bone parts of control 1 and example 1 were subjected to observation analysis by scanning electron microscopy (Crossbeam340/550, zeiss, germany). The results show that the cobalt alloy powder in the trabecular bone structure of example 1 was further sintered, suggesting that the trabecular bone composition was improved, as compared with control 1. See fig. 13 (control), fig. 14 (example 1).
Metallographic microstructure observation was performed on solid portions of example 1 and control 1. The results show that the surface of example 1 had a significantly reduced precipitated sigma phase compared to control 1, suggesting that the solid solubility of the alloying elements in the matrix was increased and the mechanical strength was enhanced. See fig. 15, fig. 16.
The tensile properties of the physical tensile test pieces of example 1 and control 1 were tested in an electronic universal tester (UTM5105, Shenzhen Sansi longitudinal and transverse science and technology Co., Ltd., China) in accordance with the standard GB/T228.1-2010, and the physical tensile test pieces of example 1 and control 1 were 5 each. As shown in Table 1, the tensile strength of example 1 was 927.35MPa, which is close to that of control 1(P > 0.05); the elongation after fracture of example 1 is 16.64 percent, which is higher than that of the control group 1(P is less than 0.01), and the fact that the solid part of the cobalt alloy tibial plateau prosthesis with the trabecular bone prepared by the invention has excellent plasticity is suggested.
Table 1 tensile test results of the solid tensile test pieces of control 1 and example 1: (
Figure BDA0002752740790000081
n is 5, P is less than 0.01, compared with control 1)
Figure BDA0002752740790000082
An electronic universal tester (UTM5105, shenzhen mitsui longitudinal and transverse science and technology ltd., china) performed a compression experiment on trabecular bone compression test pieces of example 1 and control 1, each of which had a pore diameter of 0.80mm, a porosity of 72%, and a through-hole porosity of 100%, and 5 trabecular bone compression test pieces of control 1 and example 1. The results are shown in table 2, the trabecular bone compressive strength of example 1 is 139.33MPa, which is significantly higher than that of control 1, and there is a statistical difference (P < 0.05), which indicates that the compressive performance of the trabecular bone part of the cobalt alloy tibial plateau prosthesis with trabecular bone prepared by the present invention is excellent.
Table 2 results of the trabecular bone test pieces compression resistance test of control 1 and example 1: (
Figure BDA0002752740790000083
n is 5, P < 0.05, compare with control 1)
Figure BDA0002752740790000084
Experiments prove that the cobalt alloy tibial plateau prosthesis with trabecular bone prepared in the examples 2 and 3 has similar sintering degree and compression performance of trabecular bone parts and metallographic structure and tensile performance of solid parts as the cobalt alloy tibial plateau prosthesis with trabecular bone prepared in the example 1.
As a result of finite element analysis performed on the finite element model of example 1, as shown in fig. 17, the stress concentration region at the connection part between the trabecular bone and the solid body of the cobalt alloy tibial plateau prosthesis with trabecular bone of example 1 was small, indicating that the cobalt alloy tibial plateau prosthesis with trabecular bone according to the present invention has excellent bonding strength between the trabecular bone and the solid body.

Claims (8)

1. The preparation method of the cobalt alloy tibial plateau prosthesis with the trabecular bone is characterized by comprising the following steps:
1) taking cobalt alloy powder as a raw material, carrying out 3D printing and integral forming to obtain a first intermediate product of the cobalt alloy tibial plateau prosthesis with the trabecula bone, putting the first intermediate product into a hot isostatic pressing furnace, heating to 1140-1200 ℃ under the protection of helium or argon, standing for 1-3 h at a constant temperature of 110-170 MPa, reducing to normal pressure, cooling to below 200 ℃ along with the furnace, and taking out to obtain a second intermediate product:
2) placing the second intermediate product in a programmed cooling box, cooling to-80-120 ℃ at the speed of 1 ℃/min, placing at constant temperature for 5-10 h, and taking out from the programmed cooling box; placing the mixture in liquid nitrogen for 16-36 h, and adjusting the temperature to room temperature to obtain a third intermediate product;
3) placing the third intermediate product in a programmed cooling box, cooling to-80 to-120 ℃ at the speed of 1 ℃/min, and placing for 5 to 10 hours at constant temperature; taking out the box from the programmed cooling box; placing in liquid nitrogen for 16-36 h, and adjusting the temperature to room temperature; obtaining a fourth intermediate product, and performing machining and trimming to obtain a cobalt alloy tibial plateau prosthesis with trabeculae;
the first intermediate product, the second intermediate product, the third intermediate product and the fourth intermediate product of the cobalt alloy tibial plateau prosthesis with the trabecular bone have the same structure as the cobalt alloy tibial plateau prosthesis with the trabecular bone;
the cobalt alloy tibial plateau prosthesis with the trabecular bone comprises a kidney-shaped platform support (1), wherein a dovetail-shaped convex block (3) is arranged on the upper surface of a bent part in the kidney-shaped platform support, rear grooves (5) are arranged on the outer side surfaces of two oblique branches of the dovetail-shaped convex block (3), arc-shaped convex blocks (2) are arranged on the upper surfaces of the kidney-shaped platform support (1) and the bent part opposite to the dovetail-shaped convex block (3), front grooves (6) are arranged on the inner side surfaces of the arc-shaped convex blocks (2), a handle (4) is arranged in the middle of the lower surface of the kidney-shaped platform support, trabecular bone (9) is arranged on the lower surface of the kidney-shaped platform support except for the connecting handle (4), and the trabecular bone (9) consists of a near platform trabecular bone layer (21) and a far platform trabecular bone layer (20); the aperture and porosity of the near platform bone supporting trabecular layer (21) are uniformly arranged, and the far platform bone supporting trabecular layer is arranged in a three-partition manner; the transverse diameter (10) corresponding to the kidney-shaped platform support is divided into a first section (25), a second section (26) and a third section (27) by a first marking point (11) and a second marking point (12), the lengths of the first section, the second section and the third section are 25% -38% of the transverse diameter of the kidney-shaped platform support, 24% -50% and 25% -38% of the transverse diameter of the kidney-shaped platform support in sequence, a first partition line (13) passes through the first marking point (11), and a second partition line (14) passes through the second marking point (12); the first partition line (13) and the second partition line (14) are straight lines or arc lines, and divide a far platform bone supporting trabecular layer (20) of the corresponding kidney-shaped platform support into an inner side area (15), a middle area (16) and an outer side area (17); the pore size and porosity of trabeculae in the medial region (15) are in turn greater than those in the lateral region (17) and the medial region (16).
2. The method as claimed in claim 1, wherein the cobalt alloy powder comprises, in mass%, 59 to 68% of Co, 26.5 to 30.0% of Cr, 4.5 to 7.0% of Mo, and the balance unavoidable trace impurities; the particle size of the cobalt alloy powder is 45-106 μm.
3. The method of claim 1, wherein the steps 2) and 3) of adjusting the temperature are: heating to-120 to-80 ℃, and keeping the temperature for 3 to 5 hours; heating to-40 to-20 ℃, and keeping the temperature for 3 to 5 hours; heating to 4-8 deg.c, maintaining at constant temperature for 1-3 hr, and heating.
4. The method according to claim 1, characterized in that the trabecular bone pore size of the near platform joist trabecular layer (21) is 0.36-0.50 mm, the porosity is 55-65%, and the through porosity is 100%; the thickness of the near-platform bone supporting trabecular layer (21) is 0.2mm-1 mm.
5. The method according to claim 1, wherein the first section line (13) and the second section line (14) of the distal trabecular bone layer (20) are arranged in parallel or in a splayed configuration when they are straight; the degree of an included angle (18) between the first partition line (13) and the transverse diameter (10) of the kidney-shaped platform support is 100-60 degrees, and the degree of an included angle (19) between the second partition line (14) and the transverse diameter (10) of the kidney-shaped platform support is 80-120 degrees.
6. The method according to claim 1, characterized in that the trabecular bone in the medial region of the distal platform joist trabecular layer (20) has a pore size of 1.00mm to 1.10mm, a porosity of 77.6% to 85%, and a through porosity of 100%; the aperture of the trabecula bone in the middle area is 0.74mm-0.85mm, the porosity is 70.0% -74.7%, and the through porosity is 100%; the aperture of the trabecular bone in the lateral area is 0.86mm-0.99mm, the porosity is 74.8% -77.5%, and the through porosity is 100%; the thickness of the far platform joist trabecula layer (20) is 0.5-3 mm.
7. The method according to claim 1, wherein the handle is a reducer pipe connected with a support plate, a reducer pipe connected with a support plate and having a closed bottom, a cross rib, or a bent cross rib.
8. A cobalt alloy tibial plateau prosthesis with trabecular bone prepared by the method of any one of claims 1 to 7.
CN202011191059.5A 2020-10-30 2020-10-30 Cobalt alloy tibial plateau prosthesis with trabecula and preparation method Pending CN112155802A (en)

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