CN102943190A - Anti-infection medical titanium alloy - Google Patents
Anti-infection medical titanium alloy Download PDFInfo
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- CN102943190A CN102943190A CN2011102328426A CN201110232842A CN102943190A CN 102943190 A CN102943190 A CN 102943190A CN 2011102328426 A CN2011102328426 A CN 2011102328426A CN 201110232842 A CN201110232842 A CN 201110232842A CN 102943190 A CN102943190 A CN 102943190A
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Abstract
The invention provides an anti-infection medical titanium alloy. The anti-infection medical titanium alloy is characterized in that chemical components of the existing medical titanium alloy Ti-6Al-7Nb are added with an appropriate amount of a copper element; and the mixture is subjected to special antibacterial heat treatment and then a titanium copper phase is precipitated in the medical titanium alloy so that an anti-infection function is obtained. The anti-infection medical titanium alloy can be widely used for various titanium alloy medical instruments used in the medical clinical fields of orthopedics and stomatology. The anti-infection medical titanium alloy solves the problem that the existing clinical medical titanium alloy medical instrument implantation technology causes a bacterial infection.
Description
Technical field
The present invention relates to the medical titanium alloy Material Field, be specially a kind of medical use anti-infection titanium alloy.
Background technology
Medical titanium alloy is with its excellent biocompatibility, corrosion resisting property and comprehensive mechanical property, multiple orthopaedics, Stomatological Department medicine equipment have been widely used in making, such as joint prosthesis (Kua, knee, shoulder, ankle, elbow, wrist, articulations digitorum manus etc.), the bone implanted product such as bone wound product (intramedullary nail, steel plate, screw etc.), backbone correcting internal fixation system, and mouth cavity orthodontic product (bracket, band, rescue arch wire, anchorage planting body) etc.Ti-6Al-4V, Ti-6Al-7Nb are the typical medical titanium alloys of present clinical application.
Yet as common post-operative complication, the bacterium that relevant medical medicine equipment causes infects and has become one of major issue that needs to be resolved hurrily in the 21 century medical field.According to statistics, the annual morbidity of U.S.'s orthopaedics implant infections relating reaches about 4.3%.According to the relevant data in " the ward infection control application manual " of the World Health Organization's promulgation, every day, the whole world had 1,400 ten thousand people of surpassing suffering the misery of ward infection, and wherein 60% bacterium infects relevant with the medicine equipment that uses.In the relatively flourishing U.S. of medical level, it is very high that the bacterium that causes because of the use of medicine equipment infects ratio, and relate to a lot of clinical fields, comprises cardiovascular intervention, orthopaedics, shaping, oral cavity, Neurological Surgery etc.The bacterium that medicine equipment causes infects in case occur and will cause catastrophic consequence to the patient.The patient also need experience 1-2 time operation taking-up implanted medical device again and remove focus, brings heavy economy and mental burden to the patient, also can wait the negative impact that causes in various degree to hospital and society simultaneously.For example, the infection of using implant to cause in the fracture operation can cause directly that patient's wound is prolonged does not heal, and often can cause operative failure; even cause the complication such as chronic osteomyelitis; its treatment difficulty is large, can cause serious permanent disability and the dysfunction of limbs, even amputation and threat to life.Therefore, research and develop the new medical material that self has the bacterial-infection resisting function, have great social and economic significance with the bacterial infection disease of eliminating or minimizing related medical apparatus causes.
Summary of the invention
The object of the present invention is to provide a kind of medical use anti-infection titanium alloy, an amount of copper is added on chemical composition basis at existing medical titanium alloy Ti-6Al-7Nb, through behind the special antibacterial heat-treatment, in the matrix of medical titanium alloy, separate out a kind of titanium copper phase, thereby give medical titanium alloy bacterial-infection resisting function.This titanium alloy can be widely used in all kinds of titanium alloy medicine equipments that use in the clinical medicine fields such as orthopaedics, Stomatological Department.Solve and existingly to implant the problems such as bacterium infection that cause by the medical titanium alloy medicine equipment in clinical.
For achieving the above object, the technical solution used in the present invention is: an amount of copper is added on the chemical composition basis at alpha+beta double-phase medical titanium alloy T i-6Al-7Nb, and its chemical composition is weight percentage: Ti: surplus; Cu:1-10; Al:5.5-6.5; Nb:6.5-7.5; Impurity content should satisfy the related request that China's surgical implant is used the Ti-6Al-7Nb alloy.Wherein the preferred of copper content is weight percent Cu:3-6.
In the Composition Design of medical use anti-infection titanium alloy of the present invention, copper (Cu) is most important alloying element in such alloy, and this is the prerequisite that guarantees titanium alloy bacterial-infection resisting function, also is main innovate point of the present invention.The present invention adds an amount of copper in medical titanium alloy, guaranteeing under the special thermal treatment condition, the even dispersion of titanium copper in titanium alloy separated out.Titanium copper is mainly CuTi mutually
2, contain even dispersion distribution CuTi in matrix when this
2Titanium alloy when being in moist environment or the liquid, Cu
2+From the titanium alloy surface stripping, thereby give titanium alloy bacterial-infection resisting function.If copper content is relatively low, even through special thermal treatment, also can not separate out the titanium copper phase in the titanium alloy substrate, thereby not possess stable bacterial-infection resisting performance.If copper content is relatively too high, then can cause in titanium alloy, separating out too much the titanium copper phase, can badly influence mechanical property and the process industrial art performance of titanium alloy.
The present invention also provides the special antibacterial heat-treatment technique of above-mentioned medical use anti-infection titanium alloy.At first at 900-1000 ℃ of insulation 0.5-2h, make solid solution that copper in the titanium alloy can be full and uniform in matrix, air cooling or water-cooled make the copper in the titanium alloy be in hypersaturated state to room temperature.Then at 350-550 ℃ of insulation 0.5-6h, air cooling or water-cooled are to room temperature, and oversaturated copper is separated out the titanium copper phase of q.s from titanium alloy, and titanium copper phase even dispersion is distributed.Temperature and soaking time are two very important parameters in heat treatment process.Excessively low such as temperature, driven mechanics angle will be unfavorable for separating out of titanium copper phase, and the long meeting of soaking time obviously increases the size of precipitated phase, have influence on anti-microbial property and mechanical property and the corrosion resisting property of titanium alloy.
The present invention also provides the thermal treatment selection process of described medical use anti-infection titanium alloy material: 950 ℃ of lower insulation 0.5-1.5h, and water-cooled is to room temperature, and then at 450 ℃ of lower insulation 3-5h, air cooling or water-cooled are to room temperature.
The invention has the beneficial effects as follows:
1, the present invention proposes, and is now adding the amount of copper element in the medical titanium alloy of clinical application, thereby is obtaining to have the medical use anti-infection titanium alloy novel material of broad spectrum antibacterial performance.
2, the titanium alloy among the present invention is through after the special thermal treatment, and even dispersion is distributed with titanium copper precipitated phase CuTi in titanium alloy substrate
2Thereby, give this titanium alloy bacterial-infection resisting function.
Embodiment
Embodiment 1
Add the copper of different content in the medical Ti-6Al-7Nb of at present extensive clinical application, its chemical composition is (weight) %, Ti: surplus; Cu:1-10; Al:6; Nb:7, and adopt different thermal treatment process to carry out antibacterial heat-treatment, specifically see Table 1.Resulting medical use anti-infection Ti-6Al-7Nb is carried out anti-microbial property and Biosafety performance detected result sees Table 1.
Calculate according to the following equation the sterilizing rate after the medical use anti-infection titanium alloy acts on common bacteria (intestinal bacteria, streptococcus aureus etc.):
Sterilizing rate (%)=[(control sample viable count-anti-infective titanium alloy viable count)/control sample viable count] * 100
In the formula, the control sample viable count is the viable count that carries out on the control sample (Ti-6Al-7Nb) after the microbial culture, and medical use anti-infection titanium alloy viable count refers to carry out on the medical use anti-infection titanium alloy viable count after the microbial culture.
Bacteriostatic test is specially according to standard codes such as " JIS Z 2801-2000 " antibiotic fabricated product-germ resistance test method and antibacterial effect ", GB/T 21510-2008 " nano inorganic material anti-microbial property detection method " ":
Getting respectively test is added drop-wise on control sample (Ti-6Al-7Nb), the medical use anti-infection titanium alloy sample with bacterium liquid 0.3mL.With the sterilization tweezers mulch film is overlayed on respectively on each sample, make bacterium liquid uniform contact sample, place the sterilization plate, be placed in the constant incubator 37 ℃, to cultivating 24h under the humidity 90% above condition.
Take out the sample of having cultivated 24h, add respectively the 15mL elutriant, repeatedly clean sample and mulch film, after fully shaking up, get respectively 0.1mL and be added drop-wise to the plate nutrient agar, each sample is done three Duplicate Samples, and smoothens with sterilization triangle rake, carries out live bacterial count according to the method for GB/T 4789.2 after placing 37 ℃ of thermostat containers to cultivate 48h.
Simultaneously sample being carried out the Biosafety performance detects.Adopt tetrazolium bromide (MTT) colorimetric method for determining cells survival rate, and then the biological safety of assess sample.The cryopreservation tube of MG63 cell is taken out from liquid nitrogen, melt fast in 37 ℃ of water-baths, the centrifugal supernatant of abandoning adds and moves in the culturing bottle after repeatedly blowing and beating into cell suspension in the freshly prepared DMEM high glucose medium that contains 10% foetal calf serum, and placing 37 ℃, saturated humidity, volume fraction is 5% CO
2Leave standstill cultivation in the constant incubator, the next day change liquid.Went down to posterity inverted phase contrast microscope observation of cell form in 3-4 days.
Get eugonic MG63 cell, be prepared into cell density with the DMEM nutrient solution that contains 10% foetal calf serum behind the 2.5 g/L tryptic digestions and be about 6 * 10
4The single cell suspension of/mL is inoculated in 5 96 well culture plates, and every plate is established A, B, C, D, E experimental group and zeroing group, every group of 10 holes, and the every Kong Zhongjun of experimental group adds cell suspension 100 μ l, 37 ℃, 5 % CO
2Leave standstill cultivation under the condition.
Discard original fluid after the cell attachment growth, PBS washes repeatedly, by experiment grouping application of sample.The aseptic MTT solution that every hole adds freshly prepared 5mg/ mL behind 24h, 48h, 72h, 96h, the 120h behind the application of sample continues to cultivate termination in 4 hours and cultivates.Carefully discard original fluid, every hole adds 150 μ l DMSO, and micro oscillator shaking culture plate 10 min fully dissolve crystallisate under the room temperature.Measure each hole optical density(OD) (optical density, OD) value at 490 nm wavelength places with enzyme-linked immunosorbent assay instrument.This experiment triplicate is got each cell mean.Calculate the relative proliferation rate of cell (relative growth rate, RGR), calculation formula: RGR=(experimental group OD value/substratum OD value) * 100%, then according to 5 grades of toxicity assessment standard gradings (0,1 grade of requirement that meets bio-medical material), each group result is estimated, the results are shown in Table 1.
Table 1 medical use anti-infection Ti-6Al-7Nb results of property table
The result shows, medical use anti-infection titanium alloy provided by the present invention (Ti-6Al-7Nb-Cu) has preferably sterilizing ability and Biosafety performance.Wherein, have relative other content of anti-infective titanium alloy of preferred copper content and heat treating regime and the titanium alloy material of heat treating regime and demonstrate strong germicidal action and good Biosafety performance.
Claims (4)
1. medical use anti-infection titanium alloy is characterized in that: an amount of copper is added on the chemical composition basis at alpha+beta double-phase medical titanium alloy T i-6Al-7Nb, and its chemical composition is weight percentage: Ti: surplus; Cu:1-10; Al:5.5-6.5; Nb:6.5-7.5.
2. according to medical use anti-infection titanium alloy claimed in claim 1, it is characterized in that: its copper content Cu:3-6 that is weight percentage.
3. according to medical use anti-infection titanium alloy claimed in claim 1, it is characterized in that: its thermal treatment process is: temperature 900-1000 ℃ of lower insulation 0.5-2h, and air cooling or water-cooled are to room temperature, and then at 350-550 ℃ of lower insulation 0.5-6h, air cooling or water-cooled are to room temperature.
4. according to medical use anti-infection titanium alloy claimed in claim 3, it is characterized in that: thermal treatment process is: 950 ℃ of lower insulation 0.5-1.5h, and water-cooled is to room temperature, and then at 450 ℃ of lower insulation 3-5h, air cooling or water-cooled are to room temperature.
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| CN201110232842.6A CN102943190B (en) | 2011-08-15 | 2011-08-15 | Anti-infection medical titanium alloy |
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| CN201110232842.6A CN102943190B (en) | 2011-08-15 | 2011-08-15 | Anti-infection medical titanium alloy |
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Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103194648A (en) * | 2013-04-10 | 2013-07-10 | 广西大学 | High intensity low modulus in-situ synthesis ti-based composite material and preparation method thereof |
| CN108220682A (en) * | 2018-01-29 | 2018-06-29 | 东北大学 | A kind of low anti-infective titanium alloy of modulus cupric |
| CN108300897A (en) * | 2018-01-29 | 2018-07-20 | 东北大学 | A kind of low modulus argentiferous Anti-infection medical titanium alloy |
| CN108300898A (en) * | 2018-01-29 | 2018-07-20 | 东北大学 | A kind of low anti-infective titanium alloy of modulus argentiferous |
| CN108456804A (en) * | 2018-01-29 | 2018-08-28 | 东北大学 | A kind of low modulus cupric Anti-infection medical titanium alloy |
| CN108555281A (en) * | 2018-05-15 | 2018-09-21 | 西安交通大学 | It reduces anisotropic increasing material manufacturing method and its B titanium alloys is added to increase material material |
| CN110157948A (en) * | 2019-05-29 | 2019-08-23 | 中国科学院金属研究所 | A kind of dedicated medical titanium alloy of planting body and preparation method thereof for realizing immediate implant |
| WO2020058780A1 (en) | 2018-08-06 | 2020-03-26 | University Chulalongkorn | Antimicrobial biocompatible metal alloy and manufacture of the same |
| CN111346920A (en) * | 2020-04-02 | 2020-06-30 | 陕西工业职业技术学院 | Ti6Al7Nb titanium alloy sheet and preparation method thereof |
| CN111621655A (en) * | 2020-04-30 | 2020-09-04 | 东北大学 | Preparation method and application of antibacterial titanium alloy based on micro-area primary battery theory |
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2011
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Cited By (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103194648B (en) * | 2013-04-10 | 2016-08-17 | 广西大学 | A kind of in-situ autogenic titanium base composite material of high-strength low-modulus and preparation method thereof |
| CN103194648A (en) * | 2013-04-10 | 2013-07-10 | 广西大学 | High intensity low modulus in-situ synthesis ti-based composite material and preparation method thereof |
| CN108300898B (en) * | 2018-01-29 | 2020-08-25 | 东北大学 | Low-modulus silver-containing anti-infection titanium alloy |
| CN108220682A (en) * | 2018-01-29 | 2018-06-29 | 东北大学 | A kind of low anti-infective titanium alloy of modulus cupric |
| CN108300897A (en) * | 2018-01-29 | 2018-07-20 | 东北大学 | A kind of low modulus argentiferous Anti-infection medical titanium alloy |
| CN108300898A (en) * | 2018-01-29 | 2018-07-20 | 东北大学 | A kind of low anti-infective titanium alloy of modulus argentiferous |
| CN108456804A (en) * | 2018-01-29 | 2018-08-28 | 东北大学 | A kind of low modulus cupric Anti-infection medical titanium alloy |
| CN108555281A (en) * | 2018-05-15 | 2018-09-21 | 西安交通大学 | It reduces anisotropic increasing material manufacturing method and its B titanium alloys is added to increase material material |
| WO2020058780A1 (en) | 2018-08-06 | 2020-03-26 | University Chulalongkorn | Antimicrobial biocompatible metal alloy and manufacture of the same |
| CN110157948A (en) * | 2019-05-29 | 2019-08-23 | 中国科学院金属研究所 | A kind of dedicated medical titanium alloy of planting body and preparation method thereof for realizing immediate implant |
| CN110157948B (en) * | 2019-05-29 | 2021-04-30 | 中国科学院金属研究所 | Medical titanium alloy special for implant and capable of achieving immediate implantation and preparation method thereof |
| CN111346920A (en) * | 2020-04-02 | 2020-06-30 | 陕西工业职业技术学院 | Ti6Al7Nb titanium alloy sheet and preparation method thereof |
| CN111346920B (en) * | 2020-04-02 | 2021-10-22 | 陕西工业职业技术学院 | Ti6Al7Nb titanium alloy sheet and preparation method thereof |
| CN111621655A (en) * | 2020-04-30 | 2020-09-04 | 东北大学 | Preparation method and application of antibacterial titanium alloy based on micro-area primary battery theory |
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