CN101629260A - Medical absorbable Mg-Zn-Mn-Ca magnesium alloy - Google Patents
Medical absorbable Mg-Zn-Mn-Ca magnesium alloy Download PDFInfo
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- CN101629260A CN101629260A CN200810012384A CN200810012384A CN101629260A CN 101629260 A CN101629260 A CN 101629260A CN 200810012384 A CN200810012384 A CN 200810012384A CN 200810012384 A CN200810012384 A CN 200810012384A CN 101629260 A CN101629260 A CN 101629260A
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Abstract
The invention relates to bioabsorbable magnesium alloy capable of being applied to medical implant materials. The alloy is particularly suitable to be taken as a bone implant material which is used under human body environments and can be corroded and degraded. The alloy comprises the following elements (weight percentage): 1.0 to 5.0 percent of Zn, 0.2 to 2.0 percent of Mn, 0.1 to 3.0 percent of Ca, and the balance of Mg. The material has good biocompatibility and mechanical properties, and has application value in the medical field of absorbable bone fixation instruments such as bone nails, bone plates and the like.
Description
Technical field
The present invention relates to a kind of medical absorbable Mg-Zn-Mn-Ca magnesium alloy, it is suitable as the embedded material that uses under the human body environment.The present invention has designed a kind of magnesium alloy that is particularly suitable as the corrodible degraded bone implant material that uses under the human body environment.
Background technology
In medical bone reparation and bone implant material, stainless steel, titanium and titanium alloy become widely used material because of its excellent mechanical property, biocompatibility and corrosion resistance nature.But the mechanical property and the osseous tissue of stainless steel and titanium alloy do not match, Young's modulus particularly, and for example: stainless Young's modulus is about 200GPa, and the Young's modulus of titanium alloy is about 100GPa, and the Young's modulus of osseous tissue is about 10-40GPa.Therefore, implant has been born almost all load.So in use can cause " stress shielding ", cause implant osseous tissue on every side atrophy or loose phenomenon to occur.Simultaneously, implants such as stainless steel and titanium alloy nail, hone lamella need follow-up operation that it is taken out from human body after the osseous tissue recovery from illness, have increased patient's misery and economical load.
At present, the intravascular stent of clinical application is main preparation material with stainless steel and NiTi alloy.These intravascular stents may cause the shortcoming of toxic side effect except there being the Ni stripping, also exist vascular restenosis and thrombus (being about 20%), vascellum endometrial hyperplasia, chronic inflammatory diseases, Antiplatelet therapy time long (the long-term medication treatment of needs), (blood vessel of implant frame) can't adapt to the self-sow of blood vessel, can't carry out surgery vascular reconstruction (second operation) when accident occurring, secular endothelium disorder, follow-up monitoring difficulty (can't use MRI).
High tough and the medical material that can degradation in vivo of research and development becomes the important development direction in this field.Degradable high polymer material can degradation in vivo, but its mechanical property is on the low side, and for example its Young's modulus is about 3-5GPa, when being applied to bone implant, can't be applied to bearing position; Be applied to intravascular stent, have serious resilience, can't reach the effect of support blood vessels, and polymer degraded back generation acid accumulation, the when injected organism tissue inflammation caused.
The Young's modulus of magnesium alloy is about 40GPa, and is very approaching with osseous tissue, can alleviate " stress shielding " phenomenon that stainless steel or titanium alloy embedded material cause effectively.Simultaneously, magnesium alloy have an advantages of higher tensile strength, can bear bigger load, be applied to osseous tissue carrying position, also can be applied to intravascular stent, play the effect of support blood vessels.Magnesium is to be only second to positive ion in the cell of potassium in the human body, and its participates in a series of metabolic processes in body, comprises the formation of osteocyte and accelerated bone healing ability etc.Prove that on evidence the loss of magnesium can cause that conversely osseous tissue stops growing, reduce the activity of sclerocyte and osteoclast and cause the sclerotin fragility.Magnesium is also in close relations with nerve, muscle and heart function.The magnesium amount that U.S. suggestion man need take in every day is 420mg.Therefore, as medical embedded material, it still is useful that the magnesium ion of its corrosion dissolution discharges the trace of human body with magnesium and magnesium alloy.In addition, the standard potential of magnesium and magnesium alloy lower (2.36V SCE), not corrosion-resistant, particularly containing Cl
-1Corrosion degraded easily in the ionic human body fluid.So magnesium and magnesium alloy become degradable embedded material of new generation.Magnesium and magnesium alloy originate in the 30-40 age in last century as the research of bone implant material.Although clinical application is verified, magnesium alloy has extraordinary biocompatibility, because magnesium and magnesium alloy corrode the too fast of degraded in human body, can produce hydrogen, has limited the application of magnesium alloy as embedded material.Although high-purity magnesium (such as 99.99% high-purity magnesium) has good anti-NaCl corrosive nature, its mechanical property not as good as the mechanical property of osseous tissue, also not as good as polymkeric substance, can't be applied to reparation of load bone and intravascular stent less than 65MPa.Therefore, when reducing the corrosion degradation speed of magnesium alloy in body fluid, the strength and toughness that improves magnesium alloy becomes the key that magnesium alloy is applied to medical material.
As everyone knows, the corrosive nature of alloy depends on alloying constituent and corrosive environment.Improve the purity of alloy, reduce detrimental impurity element in the alloy,, can reduce the corrosion speed of magnesium alloy effectively as Ni, Cu, Fe.It also is to improve alloy strength and improve the corrosion resistance effective means that magnesium alloy is carried out Alloying Treatment.In magnesium alloy, add aluminium element and carry out alloying, not only can improve the mechanical property of alloy, also can improve its corrosion resistance nature simultaneously.For example: the best AZ91E alloy of corrosion resistance nature has the corrosion resistance nature suitable with the A380 aluminium alloy, and tensile strength reaches 250MPa after the thermal treatment, can satisfy the requirement of mechanical property.But, the research of medical titanium alloy is shown aluminium element can produce harm to HUMAN HEALTH.Therefore, the magnesium alloy that contains aluminium is unsafe to human body.So, be necessary that development had both had good biocompatibility, have good corrosion resistance nature again, and also have the magnesium alloy of sufficient intensity.
Summary of the invention
But purpose of the present invention just provides a kind of bio-absorbable Mg-Zn-Mn-Ca magnesium alloy that can be applicable to medical embedded material, and this alloy has excellent biological compatibility and satisfied corrosion resistance nature, and can reach enough intensity.
Technical scheme of the present invention is:
A kind of medical high-strength anticorrosion magnesium alloy of the present invention contains (weight %), mainly contains: zinc (Zn) 1.0-5.0%, manganese (Mn) 0.2-2.0%, calcium (Ca) 0.1-3.0%, magnesium (Mg) surplus.
Among the present invention, by weight percentage, zinc (Zn) preferred content scope is: 1.5-3.5%.
Among the present invention, by weight percentage, manganese (Mn) preferred content scope is: 0.5-1.2%.
Among the present invention, by weight percentage, calcium (Ca) preferred content scope is: 0.3-2.0%.
Magnesium alloy of the present invention may contain a small amount of unavoidable impurities, and these unavoidable impurities can be iron (Fe), nickel (Ni), copper (Cu) and aluminium (Al).By weight percentage, every kind of content is no more than 0.1%, and total amount is no more than 0.4%.
The effect of every kind of element is as follows in the magnesium alloy of the present invention:
Zinc is one of the most basic element of human body.Zinc can promote the renewal of cell, is the trace element of needed by human, can strengthen the immunologic function of human body, keeps the g and D of body.Zinc is the composition of numerous protein, nucleic acid synthetic enzyme, is the active centre of hundreds of enzyme.Zinc is the Regular Insulin composition again, is the key factor of normal activity of earning a bare living.Zinc is damaged may to cause all physiological function disorders of human body.The maximum solid solution degree of zinc in magnesium is 6.2%, is the another kind of very effective alloy element except that aluminium, has solution strengthening and ageing strengthening dual function.Interpolation zinc can improve the room temperature strength of magnesium alloy.Simultaneously, zinc also can alleviate because of there are the corrosive nature that causes in iron, nickel, improves the corrosion resisting property of magnesium alloy.
Manganese is one of requisite 15 kinds of trace elements of human physiological functions, and human body needs the about 3-9mg of manganese amount every day, and it is the not replaceable a kind of trace element of human body intracellular metabolic.Manganese participates in the activity of plurality of enzymes in the body, is the activator of enzyme, enhances metabolism.Manganese can also impel the bone calcification, improves proteinic metabolism, promotes the savings of VITMAIN B1 in liver.When the human body manganese deficiency, can cause endocrine regulation, show malnutrition, symptoms such as sexual disorder add straightforward man's aging.Adding manganese in magnesium alloy can form intermetallic compound with the deleterious element of part and separate in the process of melting, eliminates iron, silicon and other heavy metal elements, avoids generating deleterious intergranular compound, improves the anti-NaCl corrosive power of magnesium alloy.Add manganese and can improve the intensity of magnesium alloy by a small margin, but when manganese content is excessive, can cause manganese segregation on intergranular, reduce the solidity to corrosion of magnesium alloy on the contrary.
Calcium can the refinement alloy grain, improve magnesium alloy can plasticity and intensity.Calcium can also reduce the microbattery effect of magnesium alloy, improves the corrosion resistance of magnesium alloy.Calcium is the important component that constitutes plant cell wall and animal skeleton, and 99% of calcium is present in bone and the tooth in the human body, and all the other mainly are distributed in the body fluid, to participate in some important enzyme reaction.Play an important role at aspects such as keeping heart normal contraction, neural muscle excitability, blood coagulation and maintenance cell membrane integrity.The most important biological function of calcium is that the courier acts on, the concentration difference of the inside and outside calcium ion of intracellular signal transmission depends cell.During as cell excitement, flow of calcium ions raises its concentration.When the transhipment adjusting generation of calcium ion is unusual, just produce the pathologic reaction.
Advantage of the present invention and beneficial effect are:
1, in magnesium alloy of the present invention, when improving alloy purity, add zinc element, manganese element and calcium constituent and improve corrosion resistance of alloy on the one hand, can improve the intensity of alloy on the other hand.
2, magnesium alloy of the prior art, majority all can contain aluminium in various degree, but the research of medical titanium alloy is shown, and aluminium element can produce harm to HUMAN HEALTH.Therefore, the magnesium alloy that contains aluminium is again unsafe to human body.Selected the alloying element of needed by human in the alloy of the present invention, do not contained harmful or potential harmful element, the embedded material as the human body environment uses down helps HUMAN HEALTH; Simultaneously, change composition and the existence form that exists mutually with relative proportion, obtain optimum mechanical properties and corrosion resistance nature by adjusting alloy interalloy constituent content.
Description of drawings
Fig. 1 is the microstructure of the medical absorbable Mg-Zn-Mn-Ca magnesium alloy of the embodiment of the invention 1.
Fig. 2 is the microstructure of the medical absorbable Mg-Zn-Mn-Ca magnesium alloy of the embodiment of the invention 2.
Fig. 3 is the microstructure of the medical absorbable Mg-Zn-Mn-Ca magnesium alloy of the embodiment of the invention 3.
Fig. 4 is the microstructure of the medical absorbable Mg-Zn-Mn-Ca magnesium alloy of the embodiment of the invention 4.
Fig. 5 is the microstructure of the medical absorbable Mg-Zn-Mn-Ca magnesium alloy of the embodiment of the invention 5.
Embodiment
The present invention may be better understood by following embodiment, but these examples are not used for limiting the present invention.
Alloy melting: the melting of magnesium alloy is at per-cent 99～99.5%CO by volume
2With 0.5～1%SF
6Carry out under (sulfur hexafluoride) protective atmosphere, melting is to carry out on resistance furnace, and smelting temperature is controlled at 700-820 ℃.By weight percentage, alloy adopts 99.99% pure magnesium, 99.99% pure zinc, chemical pure MnCl
2Join with calcium metal is molten, with the casting in metal pattern of the alloy after the melting.Carry out the tensile property test and the electrochemistry sample carries out the corrosive nature analysis from above-mentioned ingot casting cutting sheet tension specimen.
The tensile property test: tension test is with reference to standard GB/T228-2002 " metallic substance tensile test at room temperature method ".Tension specimen is the sheet sample, and gauge length is 20mm, and sample thickness is 2mm.Adopting gauge length is the unit elongation of the extensometer mensuration material of 10mm.
The electrochemical polarization experiment: what the electrochemical polarization experiment was used is automatic corrosion measurement system, and the exposed region area of sample is 1cm
2, specimen surface is polished to 1000# with abrasive paper for metallograph before the experiment, is polished to 1 μ m.Sample is immersed in the acetone soln, and ultrasonic cleaning dried up with hair dryer after 10 minutes.Polarization experiment carries out in filling 500ml simulated body fluid beaker, and solution temperature is controlled at 37 ± 1 ℃.Use the three-electrode system of standard to measure: reference electrode as saturated calomel electrode, supporting electrode as platinum electrode, sample as working electrode.Sweep velocity 0.3mV/s.Adopt analytical pure chemical reagent and distilled water preparation simulated body fluid, its Chemical Composition sees Table 1.
The table 1 test chemical ingredients (g/L) of simulated body fluid
| ??NaCl | ??Na 2HPO 4·2H 2O | ??NaHCO 3 | ??KCl | ??KH 2PO 4 | ??MgCl 2·6H 2O | ??MgSiO 4·7H 2O | ??CaCl 2 |
| ??8.0 | ??0.06 | ??0.35 | ??0.4 | ??0.06 | ??0.10 | ??0.2 | ??0.14 |
Embodiment 1
Obtain the Mg-Zn-Mn-Ca alloy according to above-mentioned melting method, by weight percentage, Zn is 1.8%, and Mn is 1.1%, and Ca is 0.3%.According to above-mentioned Mechanics Performance Testing, its tensile strength: 163MPa, plasticity is 7.5%.According to above-mentioned its corrosion electric current density of electrochemical polarization test determination be: 7.5 * 10
-5A/cm
2
As shown in Figure 1, from the microstructure of embodiment 1 magnesium alloy as can be seen: second the alloy compared tiny, mainly separates out along crystal boundary, and second phase of odd some point-like that distributing of intracrystalline, grain size are about 150 μ m.
Embodiment 2
Obtain the Mg-Zn-Mn-Ca alloy according to above-mentioned melting method, by weight percentage, Zn is 2.0%, and Mn is 1.2%, and Ca is 0.5%.According to above-mentioned Mechanics Performance Testing, its tensile strength: 188MPa, plasticity is 9.1%.According to above-mentioned its corrosion electric current density of electrochemical polarization test determination be: 5.7 * 10
-5A/cm
2
As shown in Figure 2, from the microstructure of embodiment 2 magnesium alloy as can be seen: second the alloy compared thick, and second phase amount is more, mainly separates out along crystal boundary, second phase of odd some point-like that distributing between the dentrite of intracrystalline, grain size is about 60 μ m.
Embodiment 3
Obtain the Mg-Zn-Mn-Ca alloy according to above-mentioned melting method, by weight percentage, Zn is 1.5%, and Mn is 1.1%, and Ca is 1.0%.According to above-mentioned Mechanics Performance Testing, its tensile strength: 136MPa, plasticity is 2.7%.According to above-mentioned its corrosion electric current density of electrochemical polarization test determination be: 5.2 * 10
-6A/cm
2
As shown in Figure 3, from the microstructure of embodiment 3 magnesium alloy as can be seen: second the alloy compared thick, and second phase amount is more, mainly separates out along crystal boundary, second phase of odd some point-like that distributing between the dentrite of intracrystalline, grain size is about 50 μ m.
Embodiment 4
Obtain the Mg-Zn-Mn-Ca alloy according to above-mentioned melting method, by weight percentage, Zn is 1.9%, and Mn is 0.7%, and Ca is 1.2%.According to above-mentioned Mechanics Performance Testing, its tensile strength: 116MPa, plasticity is 1.8%.According to above-mentioned its corrosion electric current density of electrochemical polarization test determination be: 8.7 * 10
-6A/cm
2
As shown in Figure 4, from the microstructure of embodiment 4 magnesium alloy as can be seen: second the alloy compared thick, and second phase amount is more, mainly separates out along crystal boundary, second phase of odd some point-like that distributing between the dentrite of intracrystalline, grain size is about 50 μ m.
Embodiment 5
Obtain the Mg-Zn-Mn-Ca alloy according to above-mentioned melting method, by weight percentage, Zn is 3.2%, and Mn is 0.6%, and Ca is 1.7%.According to above-mentioned Mechanics Performance Testing, its tensile strength: 129MPa, plasticity is 1.9%.According to above-mentioned its corrosion electric current density of electrochemical polarization test determination be: 1.3 * 10
-5A/cm
2
As shown in Figure 5, from the microstructure of embodiment 5 magnesium alloy as can be seen: second the alloy is very thick mutually, second phase amount is a lot, mainly separate out and almost be linked to be reticulated structure along crystal boundary, distributing some between the dentrite of intracrystalline, second mutually some has been linked to be bar-shapedly, and grain size is about 40 μ m.
Claims (5)
1, a kind of medical absorbable Mg-Zn-Mn-Ca magnesium alloy is characterized in that: by weight percentage, mainly contain: zinc 1.0-5.0%, manganese 0.2-2.0%, calcium 0.1-3.0%, magnesium surplus.
2, according to the described medical absorbable Mg-Zn-Mn-Ca magnesium alloy of claim 1, it is characterized in that: by weight percentage, the zinc content range is: 1.5-3.5%.
3, according to the described medical absorbable Mg-Zn-Mn-Ca magnesium alloy of claim 1, it is characterized in that: by weight percentage, the manganese content range is: 0.5-1.2%.
4, according to the described medical absorbable Mg-Zn-Mn-Ca magnesium alloy of claim 1, it is characterized in that: by weight percentage, the calcium contents scope is: 0.3-2.0%.
5, according to the described medical absorbable Mg-Zn-Mn-Ca magnesium alloy of claim 1, it is characterized in that: contain a small amount of unavoidable impurities element, they are iron, nickel, aluminium and copper; By weight percentage, every kind of content is no more than 0.1%, and total amount is no more than 0.4%.
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