CN117919005A - Biological fixation acetabular cup and preparation method thereof - Google Patents
Biological fixation acetabular cup and preparation method thereof Download PDFInfo
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- CN117919005A CN117919005A CN202311787590.2A CN202311787590A CN117919005A CN 117919005 A CN117919005 A CN 117919005A CN 202311787590 A CN202311787590 A CN 202311787590A CN 117919005 A CN117919005 A CN 117919005A
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- 238000002360 preparation method Methods 0.000 title abstract description 10
- 238000010227 cup method (microbiological evaluation) Methods 0.000 title description 2
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- 230000001580 bacterial effect Effects 0.000 claims abstract description 12
- 208000001132 Osteoporosis Diseases 0.000 claims abstract description 7
- 229910052782 aluminium Inorganic materials 0.000 claims description 41
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 claims description 40
- 229910045601 alloy Inorganic materials 0.000 claims description 38
- 239000000956 alloy Substances 0.000 claims description 38
- 238000003723 Smelting Methods 0.000 claims description 16
- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 claims description 13
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- 244000046052 Phaseolus vulgaris Species 0.000 claims description 12
- 238000000137 annealing Methods 0.000 claims description 9
- 238000005242 forging Methods 0.000 claims description 9
- 229910052581 Si3N4 Inorganic materials 0.000 claims description 8
- 238000005524 ceramic coating Methods 0.000 claims description 8
- 238000010438 heat treatment Methods 0.000 claims description 8
- 239000011148 porous material Substances 0.000 claims description 8
- 239000011265 semifinished product Substances 0.000 claims description 8
- HQVNEWCFYHHQES-UHFFFAOYSA-N silicon nitride Chemical compound N12[Si]34N5[Si]62N3[Si]51N64 HQVNEWCFYHHQES-UHFFFAOYSA-N 0.000 claims description 8
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 8
- 238000000034 method Methods 0.000 claims description 7
- 239000000203 mixture Substances 0.000 claims description 7
- 230000003647 oxidation Effects 0.000 claims description 7
- 238000007254 oxidation reaction Methods 0.000 claims description 7
- 239000010936 titanium Substances 0.000 claims description 7
- 229910052719 titanium Inorganic materials 0.000 claims description 7
- 239000000498 cooling water Substances 0.000 claims description 6
- 229910010165 TiCu Inorganic materials 0.000 claims description 5
- 238000012545 processing Methods 0.000 claims description 5
- 239000002994 raw material Substances 0.000 claims description 5
- 238000001816 cooling Methods 0.000 claims description 4
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- 230000001590 oxidative effect Effects 0.000 claims 2
- RJQXTJLFIWVMTO-TYNCELHUSA-N Methicillin Chemical compound COC1=CC=CC(OC)=C1C(=O)N[C@@H]1C(=O)N2[C@@H](C(O)=O)C(C)(C)S[C@@H]21 RJQXTJLFIWVMTO-TYNCELHUSA-N 0.000 abstract description 8
- 229960003085 meticillin Drugs 0.000 abstract description 8
- 241000191967 Staphylococcus aureus Species 0.000 abstract description 7
- 238000001356 surgical procedure Methods 0.000 abstract description 7
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- 229910052802 copper Inorganic materials 0.000 abstract description 5
- 239000010949 copper Substances 0.000 abstract description 5
- 230000000694 effects Effects 0.000 abstract description 5
- 229940011871 estrogen Drugs 0.000 abstract description 5
- 239000000262 estrogen Substances 0.000 abstract description 5
- 230000028327 secretion Effects 0.000 abstract description 5
- RYGMFSIKBFXOCR-UHFFFAOYSA-N Copper Chemical compound [Cu] RYGMFSIKBFXOCR-UHFFFAOYSA-N 0.000 abstract description 4
- 238000013461 design Methods 0.000 abstract description 4
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- 208000019901 Anxiety disease Diseases 0.000 description 1
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- 206010010356 Congenital anomaly Diseases 0.000 description 1
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- 208000015813 Familial avascular necrosis of femoral head Diseases 0.000 description 1
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- 241001465754 Metazoa Species 0.000 description 1
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- 102000005789 Vascular Endothelial Growth Factors Human genes 0.000 description 1
- 108010019530 Vascular Endothelial Growth Factors Proteins 0.000 description 1
- 239000003242 anti bacterial agent Substances 0.000 description 1
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- 239000012620 biological material Substances 0.000 description 1
- 230000033558 biomineral tissue development Effects 0.000 description 1
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- 238000004659 sterilization and disinfection Methods 0.000 description 1
- 210000000689 upper leg Anatomy 0.000 description 1
- LEONUFNNVUYDNQ-UHFFFAOYSA-N vanadium atom Chemical compound [V] LEONUFNNVUYDNQ-UHFFFAOYSA-N 0.000 description 1
- 230000006459 vascular development Effects 0.000 description 1
Classifications
-
- 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
- A61F2/32—Joints for the hip
- A61F2/34—Acetabular cups
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
- C12Q1/02—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving viable microorganisms
- C12Q1/18—Testing for antimicrobial activity of a material
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00011—Metals or alloys
- A61F2310/00023—Titanium or titanium-based alloys, e.g. Ti-Ni alloys
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00011—Metals or alloys
- A61F2310/00035—Other metals or alloys
- A61F2310/00077—Copper or Cu-based alloys
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00389—The prosthesis being coated or covered with a particular material
- A61F2310/0097—Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12R—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES C12C - C12Q, RELATING TO MICROORGANISMS
- C12R2001/00—Microorganisms ; Processes using microorganisms
- C12R2001/01—Bacteria or Actinomycetales ; using bacteria or Actinomycetales
- C12R2001/44—Staphylococcus
- C12R2001/445—Staphylococcus aureus
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Orthopedic Medicine & Surgery (AREA)
- General Health & Medical Sciences (AREA)
- Zoology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Wood Science & Technology (AREA)
- Biochemistry (AREA)
- Toxicology (AREA)
- Molecular Biology (AREA)
- Immunology (AREA)
- Biotechnology (AREA)
- Biophysics (AREA)
- Analytical Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Engineering & Computer Science (AREA)
- Physics & Mathematics (AREA)
- Genetics & Genomics (AREA)
- Microbiology (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
The invention provides a biological fixed acetabular cup and a preparation method thereof, and relates to the field of medical metal materials and medical instruments thereof, wherein the acetabular cup is prepared from copper-containing medical titanium alloy, and the chemical components of the acetabular cup are as follows in percentage by weight: al:4.5 to 7.5 percent; v:3.0 to 5.0 percent; cu:3.5 to 6.5 percent, ti: the balance, through unique material formula and preparation technology, the rough surface porous design of the acetabular cup is combined, and in an osteoporosis model caused by insufficient or missing estrogen secretion, the fixed effect is obviously stronger than that of a common material, so that good initial stability and long-term stability are obtained, and meanwhile, the acetabular cup can inhibit methicillin-resistant staphylococcus aureus from forming a bacterial biomembrane on the surface of the acetabular cup, so that the occurrence probability of extremely troublesome and expensive revision surgery is reduced.
Description
Technical Field
The invention relates to the field of medical metal materials and medical instruments thereof, in particular to a biological fixation acetabular cup and a preparation method thereof.
Background
The hip joint is an important weight-bearing joint of a human body and is also the joint with the largest movement range in the weight-bearing joints. Not only can stretch and flex (sit down and stand up), but also can be folded inwards and outwards (thighs are close to and far away from the midline of the body), and can also rotate inwards and outwards (the knee joint rotates inwards and outwards). In the daily life of people, the hip joint plays an important role, and no matter walking, standing, sitting and lying, the hip joint is not involved at all times. However, diseases such as osteoarthritis, aseptic necrosis of femoral head, traumatic arthritis, congenital acetabular dysplasia, etc. can cause hip joint pain and loss of function thereof, thereby seriously affecting the life of patients. Currently, artificial hip replacement surgery has become an effective means of treating hip joint diseases.
However, the inventor of the present application found in the long-term development that, when the patients suffering from the above-mentioned hip joint diseases need to undergo artificial hip joint replacement surgery, a significant proportion of patients are older women, but in older women, a very high proportion of patients suffer from osteoporosis caused by insufficient or absent estrogen secretion, and for osteoporosis patients, the bio-immobilized acetabular cup is difficult to obtain good initial stability, if effective initial stability is not obtained, the long-term stability of the prosthesis is required to be cause anxiety, and in addition, if a bacterial biofilm formed by methicillin-resistant staphylococcus aureus is formed on the implant surface in the patient, persistent infection is very easy to be caused, and due to the methicillin-resistant property of the strain, the existing medicines such as antibiotics are difficult to interfere with or treat such infection, and the deterioration of infection eventually causes loosening of the implant, which can lead to failure of the prosthesis, and cause extremely troublesome and expensive revision surgery.
Thus, there is a need to develop a biostatic acetabular cup that is resistant to osteoporotic patients and inhibits drug-resistant bacterial biofilm.
Disclosure of Invention
The invention aims to provide a biological fixation acetabular cup and a preparation method thereof, wherein a unique material formula and a preparation process are combined with a rough surface porous design of the acetabular cup, and a fixation effect obviously stronger than that of a common material is provided in an osteoporosis model caused by insufficient or missing estrogen secretion, so that good initial stability and long-term stability are obtained, and meanwhile, the acetabular cup can inhibit methicillin-resistant staphylococcus aureus from forming a bacterial biofilm on the surface of the acetabular cup, so that the occurrence probability of extremely troublesome and expensive revision surgery is reduced.
The technical scheme of the invention is as follows:
The biological fixation acetabular cup is prepared from copper-containing medical titanium alloy, and comprises the following chemical components in percentage by weight: al:4.5 to 7.5 percent; v:3.0 to 5.0 percent; cu:3.5 to 6.5 percent, ti: the balance; the outer peripheral surface of the acetabular cup is provided with a rough porous structure;
The preparation method of the acetabular cup comprises the following steps:
(1) Smelting alloy cast ingots: the raw materials of sponge titanium, tiCu intermediate alloy, alV intermediate alloy, aluminum beans and aluminum mesh are proportioned according to the following components in percentage by weight: al:4.5 to 7.5 percent; v:3.0 to 5.0 percent; cu:3.5 to 6.5 percent, ti: the balance; making an aluminum net into a container, filling the container with titanium sponge, tiCu intermediate alloy, alV intermediate alloy and aluminum beans, pressing the container into a smelting electrode by using an electrode die, and smelting the smelting electrode into alloy cast ingots; smelting by using a vacuum consumable furnace;
(2) Preparing a titanium alloy square bar: heating the alloy cast ingot to 950-1150 ℃, preserving heat for 4-8 hours, forging the total forging ratio to be 4-8, cutting the forged slab into square bars along the axial direction, heating to 900-950 ℃ again, preserving heat for 0.5-1 hour, and water-cooling;
(3) Preparing a rough blank: according to the size requirement, obtaining an acetabular cup rough blank meeting the requirement through material reduction processing;
(4) Oxidation annealing treatment: the oxidation annealing temperature of the rough blank is 600-700 ℃, the temperature is kept for 1-1.5 hours, and the rough blank is air-cooled;
(5) Semi-finishing: according to the size requirement, obtaining an acetabular cup semi-finished product meeting the requirement through machining;
(6) And (3) finishing: according to the size requirement, setting a silicon nitride ceramic coating with a rough porous structure on the surface of the semi-finished product of the acetabular cup through sintering pore-forming treatment to obtain a finished product of the acetabular cup; the thickness of the silicon nitride ceramic coating with the rough porous structure is 100-2000 microns, the average porosity is 30-70%, the average pore diameter is 100-1000 microns, and the average pore intercept is 500-1500 microns.
As a preferable technical scheme, the alloy cast ingot comprises the following vanadium and copper elements: v:4.0 to 4.5wt.%, cu:4.0 to 6.0wt.%.
In the step (1), a plurality of layers of high-purity aluminum nets are used as the aluminum net, and the number of layers is 2-8. Preferably, the aluminum net is rolled into two cylindrical aluminum net barrels with unequal bottom diameters, the two aluminum net barrels are sleeved together, a TiCu intermediate alloy is filled in a space between the two aluminum net barrels, and a mixture of aluminum beans, titanium sponge and AlV intermediate alloy is filled in the aluminum net barrels.
In the step (2), the temperature of the water-cooled cooling water is 12-22 ℃, the number of cooling water nozzles is 2-6, and the water flow rate is 1.2-2.2 m/s.
The biological fixed acetabular cup which is prepared by the method and aims at the osteoporosis patient and can inhibit the drug-resistant bacterial biomembrane is provided with an inner concave surface, the inner concave surface is used for being contacted with an acetabular lining or a femoral bulb to form a joint movable friction pair, and the roughness value Ra of the inner concave surface is 0.01-1.6 microns.
The beneficial effects of the invention are as follows:
(1) Aiming at the osteoporosis patients caused by insufficient or missing estrogen secretion, the invention provides a fixing effect which is obviously stronger than that of common materials through a unique material formula and a preparation process and by combining a rough surface porous design of the acetabular cup, so that good initial stability and long-term stability are obtained, and meanwhile, the acetabular cup can inhibit methicillin-resistant staphylococcus aureus from forming a bacterial biomembrane on the surface of the acetabular cup so as to reduce the occurrence probability of extremely troublesome and expensive revision surgery;
(2) The biological fixation acetabular cup has mature and stable required equipment and processing technology, and can meet the requirement of mass production.
Drawings
FIG. 1 is a schematic diagram of a double layer high purity aluminum mesh.
FIG. 2 is a block diagram of an acetabular cup.
Fig. 3 is a perspective view of an acetabular cup.
Fig. 4 is a front view of an acetabular cup.
Fig. 5 is a rear view of the acetabular cup.
Fig. 6 is a left side view of the acetabular cup.
Fig. 7 is a right side view of the acetabular cup.
FIG. 8 is a top view of an acetabular cup.
Fig. 9 is a bottom view of the acetabular cup.
Detailed Description
The application will be illustrated and explained by means of several specific examples and comparative examples, which should not be taken as limiting the scope of the application.
Raw materials:
Grade 0 titanium sponge (99.8%) available from jindati industries, inc.
TiCu master alloy (composition wt% 50% Ti, 50% Cu), alV master alloy (composition wt% 40% Al, 60% V) purchased from Beijing Xinrong Source Metal materials Co.
High purity aluminum beans (99.9%) were purchased from eastern high new metals materials limited.
High purity aluminum mesh (99.9%) from eastern high new metals materials limited.
The titanium alloy raw materials used in the embodiment are grade 0 sponge titanium, tiCu intermediate alloy, alV intermediate alloy and high-purity aluminum bean, a double-layer high-purity aluminum net is used as a container (shown in figure 1) when the electrode is pressed and smelted, the TiCu intermediate alloy is filled in the middle of the aluminum net, the mixture of the aluminum bean, the sponge titanium and the AlV intermediate alloy is filled in an aluminum net barrel, the electrode is pressed into a smelting electrode by an electrode die, and the pressed electrode is smelted into an alloy cast ingot; heating the alloy cast ingot to 975 ℃, preserving heat for 4 hours, forging the total forging ratio to be 6, cutting the forged plate blank into square bars along the axial direction, heating to 950 ℃ again, preserving heat for 1 hour, and cooling to room temperature. And according to the size requirement, obtaining the acetabular cup rough blank meeting the requirement through die forging processing. The oxidation annealing temperature of the rough blank is 650 ℃, the temperature is kept for 1 hour, and the rough blank is air-cooled to room temperature. And (5) machining according to the size requirement to obtain the acetabular cup semi-finished product meeting the requirement. According to the size requirement, setting a silicon nitride ceramic coating with a rough porous structure on the surface of the semi-finished product of the acetabular cup through sintering pore-forming treatment to obtain a finished product of the acetabular cup; the thickness of the silicon nitride ceramic coating with the rough porous structure is 100-2000 microns, the average porosity is 30-70%, the average pore diameter is 100-1000 microns, and the average pore intercept is 500-1500 microns.
The proportions of the titanium alloy elements used in each of the examples and comparative examples are shown in Table 1.
Table 1 titanium alloy compositions (wt.%) used in examples and comparative examples
In vitro co-culture assay:
the methicillin-resistant staphylococcus aureus strain is inoculated on the inclined plane of a nutrient agar culture medium (NA), is cultured for 24 hours at the temperature of (37+/-1), and is preserved at the temperature of 0-5 ℃ for no more than 1 month to be used as the inclined plane preserving strain.
The slant-preserving bacteria are transferred onto a plate nutrient agar medium, and cultured for 24 hours at the temperature of (37+/-1) DEG C, and transferred 1 time a day for no more than 2 weeks. Fresh bacterial cultures (24 h in-transit) should be used for the test after 2 consecutive transfers.
A small amount (1-2 loops) of fresh bacteria is taken from the culture medium by an inoculating loop, added into the culture solution, sequentially diluted by 10 times, counted by a cell counting plate, and the diluted solution with the bacterial solution concentration of 5.0X10 5cfu/ml～10.0×105 cfu/ml is selected as the bacterial solution for the test.
15 Sterilization plates with phi 90mm are prepared, 5-6 sterile filter papers with phi 90mm are paved on the bottoms of the plates, and a proper amount of sterile purified water is poured into the plates to enable the filter papers to fully absorb water. The filter paper is preferably pressed with sterile forceps without precipitation of a large amount of water.
15 Sterile filters of 0.24 μm. Times.50 mm were covered on sterile filters of each dish and spread flat. 0.2ml of the test bacterial liquid was dropped on a sterile filter membrane having a diameter of 0.24 μm X50 mm.
A negative control TC4 alloy sample (A), a blank control medical high-density polyethylene sample (B) and a sample supply (C) are clamped by using a sterilizing forceps, 5 samples are parallel to each other, and are covered on a sterile filter membrane with phi of 0.24 mu m multiplied by 50mm, so that bacterial liquid is uniformly contacted with the samples, and the samples are cultured for 24 hours under the condition of (37+/-1) DEG C.
Taking out the samples cultured for 24 hours, adding 20ml of eluent, repeatedly washing the sample A, the sample B, the sample C and the cover film (preferably, washing the film by clamping with forceps), and shaking thoroughly. 1ml of eluent stock solution is sucked by a sterilizing gun head and transferred into a sterile culture dish, nutrient agar culture medium cooled to 46 ℃ is timely injected into the culture dish for about 15ml, and the culture dish is rotated to be uniformly mixed. The plating operation was repeated 2 times to obtain 2 elution-crude culture dishes. And (3) slowly injecting 1ml of eluent stock solution into a test tube containing 9ml of sterilized normal saline along the tube wall (note that the tip of the gun head does not touch the diluent in the tube), shaking the test tube, and uniformly mixing to prepare the eluent with the ratio of 1:10.
1Ml of the eluting diluent 1:10 is transferred into a sterile culture dish, and the nutrient agar medium cooled to 46 ℃ is injected into about 15ml of the culture dish in time, and the culture dish is rotated to be uniformly mixed. The plating operation was repeated 2 times to obtain 2 plates of 1:10 elution diluent. Taking 1ml of 1:10 eluting diluent, slowly injecting into a test tube containing 9ml of sterilized normal saline along the tube wall (note that the tip of the gun head does not touch the diluent in the tube), shaking the test tube, and mixing uniformly to obtain 1:100 eluting diluent.
1Ml of the eluting diluent 1:100 is transferred into a sterile culture dish, nutrient agar medium cooled to 46 ℃ is timely injected into the culture dish for about 15ml, and the culture dish is rotated to be uniformly mixed. The plating operation was repeated 2 times to obtain 2 plates of 1:100 elution diluent. Taking 1ml of 1:100 eluting diluent, slowly injecting into a test tube containing 9ml of sterilized normal saline along the tube wall (note that the tip of the gun head does not touch the diluent in the tube), shaking the test tube, and mixing uniformly to obtain 1:1000 eluting diluent.
1Ml of the eluting diluent 1:1000 is transferred into a sterile culture dish, nutrient agar medium cooled to 46 ℃ is timely injected into the culture dish for about 15ml, and the culture dish is rotated to be uniformly mixed. The plating operation was repeated 2 times to obtain 2 plates of 1:1000 elution diluent.
When plate colony counting is carried out, naked eyes can be used for observing, and magnifying glass is used for checking if necessary, so that omission is avoided. After counting the colonies of each plate, the average colony count of each plate at the same dilution was determined. Plates with colony numbers between 30 and 300 were selected as a colony count measurement standard.
Two plates should be used for one dilution, an average number of two plates should be used, when one plate has larger plate-shaped colony growth, the plate without plate-shaped colony growth should not be used as the colony number of the dilution, if the plate-shaped colony is less than half of the plate, and the colony distribution in the other half is very uniform, the number of the whole dish colonies can be calculated by multiplying 2 after the half plate. If there is chain colony growth in the plate (there is no obvious limit between colonies), if there is only one chain, it can be regarded as one colony; if there are several strands of different origin, each strand should be considered as a colony meter. Dilutions should be selected with average colony counts between 30 and 300, multiplied by dilution fold to fill out the report. If there are two dilutions, the number of colonies grown is between 30 and 300, depending on the ratio of the two. If the ratio is less than or equal to 2, reporting the average; if greater than 2, the smaller number is reported. If the average colony count for all dilutions is greater than 300, the dilution should be reported as the average colony count for the highest dilution multiplied by the dilution. If the average colony count for all dilutions is less than 30, the average colony count at the lowest dilution should be reported as multiplied by the dilution. If all dilutions were sterile, they were reported as less than 1 times the lowest dilution (see example 6 in table 2). If the average colony count for all dilutions is not between 30 and 300, with a fraction greater than 300 or less than 30, the average colony count closest to 30 or 300 is multiplied by the dilution fold report (see example 7 in Table 2).
Colony numbers are reported as actual numbers within 100, and at values greater than 100, two significant digits are employed, followed by a number after the two significant digits, calculated by rounding. To shorten the number zero after the number, it can also be expressed by an index of 10 (see table 2).
TABLE 2 dilution selection and colony count reporting method
Multiplying the measured viable count result by 100 to obtain actual viable count values of the recovered viable count after culturing the sample A, the sample B and the sample C for 24 hours, wherein the actual viable count values are A, B, C respectively, so that the test result is ensured to meet the following requirements, and otherwise, the test is invalid:
The 5 parallel viable bacteria values of the same blank control sample B are in line with (the highest logarithmic value-the lowest logarithmic value)/the average viable bacteria value logarithmic value is not more than 0.3;
the actual recovery live bacteria value A of the sample A should be no less than 1.0X10 5 cfu/tablet, and the actual recovery live bacteria value B of the sample B should be no less than 1.0X10 4 cfu/tablet.
The antibacterial ratio is calculated according to formula (A.1).
R(％)＝(B-C)/B×100 (A.1)
Wherein:
r-antibacterial rate,%;
B, average recovery bacteria number of a blank control sample, cfu/tablet;
c, average recovery bacteria number of antibacterial samples, cfu/tablet.
The results are shown in Table 3.
Table 3 antibacterial rate data for examples and comparative examples
As for the implant made of the different titanium alloy components, namely the material formula and the preparation process, through various in vivo and in vitro experiments, specific experimental methods and processes are shown in literature (L.Ren et αl.,Antibacterial Properties of Ti-6Al-4V-xCu Alloys,Journal of Materials Science&Technology Volume 30,Issue 7,July 2014,Pages 699-705&X.Y.Zhang et al.,Promoting osteointegration effect of Cu-alloyed titanium in ovariectomized rats,Regenerative Biomaterials,2022,9,rbac011),, and can prove that better vascular networks can be formed around the implant made of the medical copper-containing titanium alloy compared with the common titanium alloy on the market at present in an animal living environment with insufficient or absent estrogen secretion, and the early osteogenesis is promoted by up-regulating the expression of VEGF around the implant in the initial stage of implantation. The dense vascular network can transmit osteogenic related proteins and related necessary ions to surrounding bone tissues, promote proliferation, differentiation and mineralization of osteoblasts, promote vascular development and improve a bone self-reconstruction system, and in addition, the coarse surface porous design is combined to provide a fixation effect which is significantly stronger than that of common materials, so that good initial stability and long-term stability are obtained, and meanwhile, the acetabular cup can provide a relative antibacterial rate of more than 99% in a co-culture model of an implant contaminated by methicillin-resistant staphylococcus aureus bacteria by taking a co-culture result of TC4 titanium alloy contaminated by methicillin-resistant staphylococcus aureus bacteria as a comparison standard (see table 3), so that the occurrence probability of extremely troublesome and expensive revision surgery is reduced.
The invention is not a matter of the known technology.
The above embodiments are provided to illustrate the technical concept and features of the present invention and are intended to enable those skilled in the art to understand the content of the present invention and implement the same, and are not intended to limit the scope of the present invention. All equivalent changes or modifications made in accordance with the spirit of the present invention should be construed to be included in the scope of the present invention.
Claims (9)
1. A biosolidated acetabular cup characterized by being prepared by a method comprising the steps of:
(1) Smelting alloy cast ingots: the raw materials of sponge titanium, tiCu intermediate alloy, A1V intermediate alloy, aluminum beans and aluminum mesh are proportioned according to the following components in percentage by weight: a1:4.5 to 7.5 percent; v:3.0 to 5.0 percent; cu:3.5 to 6.5 percent, ti: the balance; making an aluminum net into a container, filling the container with titanium sponge, tiCu intermediate alloy, alV intermediate alloy and aluminum beans, pressing the container into a smelting electrode by using an electrode die, and smelting the smelting electrode into alloy cast ingots; smelting by using a vacuum consumable furnace;
(2) Preparing a titanium alloy square bar: heating the alloy cast ingot to 950-1150 ℃, preserving heat for 4-8 hours, forging the total forging ratio to be 4-8, cutting the forged slab into square bars along the axial direction, heating to 900-950 ℃ again, preserving heat for 0.5-1 hour, and water-cooling;
(3) Preparing a rough blank: according to the size requirement, obtaining an acetabular cup rough blank meeting the requirement through material reduction processing;
(4) Oxidation annealing treatment: the oxidation annealing temperature of the rough blank is 600-700 ℃, the temperature is kept for 1-1.5 hours, and the rough blank is air-cooled;
(5) Semi-finishing: according to the size requirement, obtaining an acetabular cup semi-finished product meeting the requirement through machining;
(6) And (3) finishing: according to the size requirement, setting a silicon nitride ceramic coating with a rough porous structure on the surface of the semi-finished product of the acetabular cup through sintering pore-forming treatment to obtain a finished product of the acetabular cup; the thickness of the silicon nitride ceramic coating with the rough porous structure is 100-2000 microns, the average porosity is 30-70%, the average pore diameter is 100-1000 microns, and the average pore intercept is 500-1500 microns.
2. The acetabular cup of claim 1 wherein in step (1) the aluminum mesh is rolled into two cylindrical aluminum mesh barrels having unequal bottom diameters, the two aluminum mesh barrels are nested together, the space between the two aluminum mesh barrels is filled with a TiCu master alloy, and the interior of the aluminum mesh barrels is filled with a mixture of aluminum beans, titanium sponge and an AlV master alloy.
3. The acetabular cup of claim 1 wherein in step (2) the water cooled cooling water has a temperature of 12-22 ℃, a number of cooling water nozzles of 2-6, and a water flow rate of 1.2-2.2 m/s.
4. The acetabular cup of claim 1 wherein in step (4) the rough surface imperfections are removed using a lathe prior to the oxidative annealing process.
5. The acetabular cup of any of claims 1-4 wherein the hemispherical acetabular cup has an inner concave surface for contact with an acetabular liner or a femoral head to form a mobile joint friction pair, the inner concave surface having a roughness value Ra of 0.01-1.6 microns.
6. A method for preparing a biological fixation acetabular cup for osteoporosis patients, which can inhibit drug-resistant bacterial biomembrane, comprising the following steps:
(1) Smelting alloy cast ingots: the raw materials of sponge titanium, tiCu intermediate alloy, A1V intermediate alloy, aluminum beans and aluminum mesh are proportioned according to the following components in percentage by weight: a1:4.5 to 7.5 percent; v:3.0 to 5.0 percent; cu:3.5 to 6.5 percent, ti: the balance; making an aluminum net into a container, filling the container with titanium sponge, tiCu intermediate alloy, A1V intermediate alloy and aluminum beans, pressing the container into a smelting electrode by using an electrode die, and smelting the smelting electrode into alloy cast ingots; smelting by using a vacuum consumable furnace;
(2) Preparing a titanium alloy square bar: heating the alloy cast ingot to 950-1150 ℃, preserving heat for 4-8 hours, forging the total forging ratio to be 4-8, cutting the forged slab into square bars along the axial direction, heating to 900-950 ℃ again, preserving heat for 0.5-1 hour, and water-cooling;
(3) Preparing a rough blank: according to the size requirement, obtaining an acetabular cup rough blank meeting the requirement through material reduction processing;
(4) Oxidation annealing treatment: the oxidation annealing temperature of the rough blank is 600-700 ℃, the temperature is kept for 1-1.5 hours, and the rough blank is air-cooled;
(5) Semi-finishing: according to the size requirement, obtaining an acetabular cup semi-finished product meeting the requirement through machining;
(6) And (3) finishing: according to the size requirement, setting a silicon nitride ceramic coating with a rough porous structure on the surface of the semi-finished product of the acetabular cup through sintering pore-forming treatment to obtain a finished product of the acetabular cup; the thickness of the silicon nitride ceramic coating with the rough porous structure is 100-2000 microns, the average porosity is 30-70%, the average pore diameter is 100-1000 microns, and the average pore intercept is 500-1500 microns.
7. The acetabular cup of claim 6 wherein in step (1) the aluminum mesh is rolled into two cylindrical aluminum mesh barrels having unequal bottom diameters, the two aluminum mesh barrels are nested together, the space between the two aluminum mesh barrels is filled with a TiCu master alloy, and the interior of the aluminum mesh barrels is filled with a mixture of aluminum beans, titanium sponge and an AlV master alloy.
8. The acetabular cup of claim 6 wherein in step (2) the water cooled cooling water has a temperature of 12-22 ℃, a number of cooling water nozzles of 2-6, and a water flow rate of 1.2-2.2 m/s.
9. The acetabular cup of claim 6 wherein in step (4) the rough surface imperfections are removed using a lathe prior to the oxidative annealing process.
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