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WO2011117630A1 - Alliage de magnésium contenant des terres rares lourdes - Google Patents

Alliage de magnésium contenant des terres rares lourdes Download PDF

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Publication number
WO2011117630A1
WO2011117630A1 PCT/GB2011/050579 GB2011050579W WO2011117630A1 WO 2011117630 A1 WO2011117630 A1 WO 2011117630A1 GB 2011050579 W GB2011050579 W GB 2011050579W WO 2011117630 A1 WO2011117630 A1 WO 2011117630A1
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Prior art keywords
weight
alloy
content
alloys
rare earths
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PCT/GB2011/050579
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English (en)
Inventor
Paul Lyon
Antony James Boden
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Magnesium Elektron Limited
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Publication date
Application filed by Magnesium Elektron Limited filed Critical Magnesium Elektron Limited
Priority to EP11712655A priority Critical patent/EP2550376A1/fr
Publication of WO2011117630A1 publication Critical patent/WO2011117630A1/fr

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Classifications

    • C—CHEMISTRY; METALLURGY
    • C22—METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
    • C22C—ALLOYS
    • C22C23/00—Alloys based on magnesium
    • C22C23/06—Alloys based on magnesium with a rare earth metal as the next major constituent
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/02—Inorganic materials
    • A61L31/022—Metals or alloys
    • C—CHEMISTRY; METALLURGY
    • C22—METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
    • C22F—CHANGING THE PHYSICAL STRUCTURE OF NON-FERROUS METALS AND NON-FERROUS ALLOYS
    • C22F1/00—Changing the physical structure of non-ferrous metals or alloys by heat treatment or by hot or cold working
    • C22F1/06—Changing the physical structure of non-ferrous metals or alloys by heat treatment or by hot or cold working of magnesium or alloys based thereon

Definitions

  • the present invention relates to magnesium alloys containing heavy rare earths which possess good processability and/or ductility, particularly when wrought, whilst retaining good resistance to corrosion and/or degradation, and are particularly suitable for fabrication into medical implants, for example by extrusion.
  • the described alloys consist of
  • inventive Mg alloy for manufacturing an implant causes an improvement in processability, an increase in corrosion resistance and biocompatibility compared to conventional magnesium alloys, especially WE alloys such as WE43 or WE54.
  • the amount of RE addition may be expected to affect the amount of retained clusters and particles present in the microstructure.
  • the content of at least one of the heavy rare earths selected from Er, Ho, Lu, Tm and Tb in the Mg alloy is at least 5.5% by weight.
  • Y in the Mg alloy is greater than or equal to 0.05% by weight.
  • the content of Nd in the Mg alloy is 0 - 5% by weight, preferably greater than or equal to 0.05%> by weight, more preferably 0.05 - 2.5% by weight, and even more preferably above 1.3% by weight.
  • the content of Nd is above 5% by weight, the ductility of the alloy deteriorates due to a limited solubility of Nd in Mg.
  • the content of Gd in the Mg alloy is 0 - 9% by weight, preferably 0 - 7%, and more preferably no more than 5%, or for some alloys no more than 2%, by weight.
  • Gd can reduce the degradation of the alloy in SBF tests and improve its EAC behaviour.
  • Levels of Gd approaching the solubility limit in a given alloy reduce ductility.
  • Gd addition can be as low 0.2% by weight, whilst for others Gd can be avoided altogether.
  • the content of Dy in the Mg alloy is 0 - 8.0% by weight, preferably 0 - 4% by weight, most preferred 0 - 0.6% by weight.
  • Dy behaves in a similar manner to Gd.
  • the content of Er in the Mg alloy is preferably 5.5% by weight up to its solubility limit, which is in the present alloys about 25% by weight, preferably 6 - 16%> by weight, most preferred 6.5 - 11% by weight. Er can reduce the degradation of the alloy in SBF tests and improve its EAC behaviour and strength.
  • the content of Ho in the Mg alloy is preferably 5.5% by weight up to its solubility limit, which is in the present alloys about 25% by weight, preferably 6 - 16% by weight, most preferred 6.5 - 11% by weight. Ho can reduce the degradation of the alloy in SBF and increases strength.
  • the content of Lu in the Mg alloy is preferably at least 0.1 % by weight, more preferably at least 0.2% by weight.
  • the content of Lu in the Mg alloy is 5.5% by weight up to its solubility limit, which is in the present alloys about 25% by weight, preferably 6 - 16% by weight, most preferred 6.5 - 11% by weight. Lu can reduce the degradation of the alloy in SBF tests and improve its EAC behaviour and strength.
  • the content of Tm in the Mg alloy is preferably 5.5% by weight up to its solubility limit, which is in the present alloys about 25% by weight, preferably 6 - 16% by weight, most preferred 6.5 - 11% by weight.
  • the content of Tm in the Mg alloy is preferably 5.5% by weight up to its solubility limit, which is in the present alloys about 25% by weight, preferably 6 - 16% by weight, most preferred 6.5 - 11% by weight.
  • the content of Tb in the Mg alloy is preferably 5.5% by weight up to its solubility limit, which is in the present alloys about 25% by weight, preferably 6 - 16% by weight, most preferred 6.5 - 11% by weight.
  • the content of Tb in the Mg alloy is preferably 5.5% by weight up to its solubility limit, which is in the present alloys about 25% by weight, preferably 6 - 16% by weight, most preferred 6.5 - 11% by weight.
  • the same effect on degradation of the alloy and improvement of the EAC behaviour and strength is expected as for Er, Ho, Lu, and Tm.
  • a total content of Dy, Gd, Ho, Er, Lu, Tm and Tb in the Mg alloy is preferably less than 11% by weight in order to achieve a good combination of ductility, strength and EAC behaviour.
  • the content of Zr in the Mg alloy is 0 - 1.5% by weight, preferably at least 0.01% by weight, and more preferably 0.1 - 0.9% by weight.
  • zirconium has a significant benefit of reducing the grain size of magnesium alloys, especially of the pre-extruded material, which improves the ductility of the alloy. Further, Zr removes contaminants from the melt.
  • the content of Ca in the Mg alloy is 0 - 3% by weight, preferably 0 - 1% by weight.
  • Ca can have a significant benefit of reducing the grain size of magnesium alloys.
  • Ca addition should be avoided altogether.
  • the content of Zn and/or Mn in the Mg alloy is 0 - 2% by weight, preferably 0 - 0.5% by weight, more preferably less than 0.40% by weight. Both Zn and Mn can contribute to precipitation and can also affect general corrosion, but Zn is preferred to Mn. For some alloys Zn addition should be avoided altogether.
  • the content of In in the Mg alloy is 0 % by weight up to its solubility limit, which in the present alloys can be as high as about 15% by weight, and preferably no more than 5% by weight. In can have a benefit of improving the corrosion performance of magnesium alloys. For some alloys In addition should be avoided altogether.
  • the content of Sc in the Mg alloy is 0% by weight up to its solubility limit, which in the present alloys can be as high as about 15% by weight, and preferably no more than 7% by weight, more preferably no more than 5% by weight. Sc can have a positive effect on corrosion resistance. For some alloys Sc addition should be avoided altogether.
  • Al can be added to the Mg alloy in an amount for some alloys as high as 10% by weight, but generally should be added in an amount less than 7% by weight, preferably less than 6% by weight, in order not to significantly adversely affect the alloy's strength, ductility or EAC behaviour.
  • any Al addition should be no higher than 4% and more preferably less than 3% by weight. In some embodiments, Al addition should be less than 0.05%) by weight.
  • Al addition should be avoided altogether (ie Al should not be intentionally added).
  • the total content of impurities in the alloy should be less than 0.3% by weight, more preferred less than 0.2% by weight.
  • the following maximum impurity levels should be preserved: Fe, Si, Cu, Mn, and Ag each less than 0.05% by weight Ni less than 0.006% by weight
  • La, Ce, Pr,Tb, Sm, Eu and Yb less than 0.15% by weight, preferably less than 0.1% by weight
  • Other preferred features are set out in the accompanying claims in line with the preferred features described in PCT/GB2009/002325, such as particle size.
  • a sample of the alloy to be assayed is stored in a closed sample container with a defined quantity of the testing medium at 37°C.
  • the sample is removed and examined for corrosion traces in a known way.
  • FIG. 8 shows an example of secondary cracking caused by EAC in SBF solution.
  • FIG. 9 shows the relative collapse pressure of stents made from WE43 and from an alloy (MI0029) according to the invention.
  • FIG. 10 shows the relative degradation score of stents made from WE43 and from an alloy (MI0029) according to the invention.
  • melts were carried out according to the following casting technique:
  • High-purity starting materials (generally >99%) were melted in steel crucibles under a protective gas (C0 2 /2% SF 6 ). The temperature was raised to 760°C to 800°C before the melt was homogenized by stirring. The melt was cast to form bars with a nominal diameter of 120 mm and a length of 300 mm. Next the bars were machined to a nominal diameter of 75 mm with a length of 150 mm to 250 mm and homogenized for 4- 8 hours. Near to the melts' solidus temperature, homogenization was typically achieved at approximately 525°C.
  • clusters/particles are brittle.
  • Figure 1 is a comparatively "clean microstructure" despite a 12.7% addition of Er - ductility is good (19%).
  • the alloy of Figure 4 illustrates that a combination of lower Er compared to the alloy of Figure 1 (8% Er vs. 13% Er) can achieve a comparatively "clean microstructure" and similar properties to that of alloy of Figure 1, by combining Nd with this lower Er content.
  • Figure 5 illustrates the effect of Lu, which appears to provide a similar manner to Er, however appears more tolerant to Nd additions in terms of freedom of particles and clusters compared with the alloy of Figure 4.
  • Figures 6 and 7 illustrate the difference in micro-structure of drawn tubes from the reference material WE43 and micro-extruded tubes from the inventive alloy MI0029. It clearly can be seen that the micro-extruded has significantly fewer and smaller precipitates than drawn material. In addition the grain size of the extruded tubes is significantly reduced from about 15-20 ⁇ for the as extruded bulk materials to 2-15 ⁇ in the drawn condition.
  • Tests in immersed SBF, of the alloys of the invention illustrates that the reduction on degradation rate (corrosion). This is best viewed as a percentage of the reference alloy WE43 type. In the best case examples from the invention show a greater than 10 fold improvement in degradation.
  • Table 4 provides data on EAC tests. Taking WE43 type alloy (MI0047) as a reference, it can be seen that as the HRE content increase, the absolute tolerable stress increase. This improvement is also seen as a percentage of the actual strength of the material when tested in air (no SBF media effect). The closer this value is to 100%, the less the fracture is related to the media and therefore the less prone the material is likely to be to EAC (SCC) in that media. Er additions perform well to at least 14wt %, however at 18 wt % the performance is reduced to beneath that of the reference WE43 type alloy. Other HREs perform in different ways. For example whilst Gd can improve EAC resistance of the alloys tested, and Lu also appears good, Ho performs poorly.
  • Figure 8 shows the fracture appearance of comparative alloy DF9400. The fracture shows primary and secondary cracking. This type of cracking with secondary cracking remote from the primary crack can be representative of SCC.
  • Table 5 shows a comparison of the Mg ion release from bulk material, extruded tubes and the respective stents from these extruded sleeves. Values are given in percentage of the respective reference material (reference WE 43 bulk material from Table 2 as reference for the inventive bulk material, drawn tube of WE43 for the extruded tubes of the inventive alloy, and stents from drawn tube of WE43 for the stents manufactured from extruded tubes of the inventive alloys).
  • the melt was homogenised by stirring, and then cast in a mold to form bars with a nominal diameter of 120mm and a length of 300mm. After casting and cooling, the bars were machined to a nominal diameter of 75mm with a length of 250mm and homogenised for 8 hours at approximately 525°C. The material was then reheated to 400-500°C and extruded using a hydraulic press. The resulting round rods had a diameter of 12.7 mm. Before further processing or testing, 30 cm long pieces were removed from the start and end of the extrusions.
  • the mechanical properties of the extruded bulk material compared to WE43 were as follows:
  • A 18%, which is ca. 1-7% points less than for WE43.
  • Stents are endoluminal endoprostheses having a carrier structure.
  • the structure comprises a hollow body which is open at both ends and a peripheral wall which is formed by a plurality of struts connected together.
  • the struts can be folded in a zig-zag configuration.
  • the struts have typical dimensions in width and thickness of 30-450 ⁇ .
  • the further processing of the extruded alloy into tubes was accomplished by a micro-extrusion process. Slugs of alloy were machined from the bulk material. These slugs were processed by hot pressing at elevated temperatures of between 200°C and 480°C and extrusion speeds of 0.001 mm/s to 600 mm/s.
  • the micro-extruded tubes for vessel scaffolds had a length of not less than 30 mm, a diameter of ca. 2 mm and a wall thickness between 50 and 400 ⁇ .
  • YTS 189 MPa, which is ca. 25 MPa higher than for drawn WE43 tubes
  • stents were produced from the micro- extruded tube by laser cutting and electro-polishing.
  • the stents Prior to testing, the stents were crimped onto balloon catheters to a diameter of less than 1.5 mm and sterilized, e.g. by ETO or e-beam. The stents were than over- expanded to their nominal diameter plus 0.5 mm into mock arteries with respective diameters which has been filled with simulated body fluid (SBF). Previous tests have shown that over-expansion to about 1 mm in diameter is possible for the alloy according to the invention, whereas an identical stent manufactured from WE43 tolerates significant less over-expansion. The improved dilatation reserve of the inventive alloy contributes significantly to device safety in clinical practice.
  • SBF simulated body fluid
  • Figure 9 shows the relative collapse pressure over a 28 day period of a stent made from WE43 alloy and one made from the alloy of the invention.
  • the relative collapse pressure is calculated by measuring the absolute collapse pressure and then expressing this as a percentage of the initial collapse pressure of the stent made from WE43.
  • these results showed that the stent made from the alloy of the invention exhibited a significant higher initial relative collapse pressures (+10%) as a result of greater strength, lower yield ratio and higher strain hardening.
  • the stent made from the alloy of the invention maintained a high relative collapse pressure over a significant longer period of time without fractures or fragmentation, indicating a significantly lower susceptibility to environmental assisted cracking (ie corrosion fatigue).
  • Figure 10 shows the relative degradation score over a 28 day period of a stent made from WE43 alloy and one made from the alloy of the invention.
  • the relative degradation score is calculated by measuring the weight of the stent and then expressing this as a percentage of the initial weight of the stent made from WE43.
  • these results showed that the stent made from the alloy of the invention exhibited a significantly lower levels of corrosion (-25%) than the stent made from WE43 when under cyclic load in a corrosive environment.

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Abstract

La présente invention se rapporte à des alliages de magnésium qui présentent une bonne capacité de traitement et/ou une bonne ductibilité tout en conservant une bonne résistance à la corrosion et/ou à une dégradation. Lesdits alliages de magnésium comprennent une ou plusieurs terres rares lourdes sélectionnées dans le groupe constitué par : l'erbium (Er), l'holmium (Ho), le lutétium (Lu), le thulium (Tm) et le terbium (Tb) en une quantité totale supérieure à 5,5 % et inférieure à leur limite de solubilité de solide respective dans l'alliage comme cela est mesuré à une température de 500 °C, et une quantité d'yttrium (Y) comprise entre 0 et 10 % en poids. Facultativement, les alliages comprennent un ou plusieurs éléments chimiques parmi les éléments chimiques suivants : le néodyme (Nd) en une quantité comprise entre 0 et 5 % en poids; le dysprosium (Dy) en une quantité comprise entre 0 et 8 % en poids; le gadolinium (Gd) en une quantité comprise entre 0 et 9 % en poids; le zirconium (Zr) en une quantité comprise entre 0 et 1,5 % en poids; l'aluminium (Al) en une quantité comprise entre 0 et 10 % en poids; le zinc (Zn) et/ou le manganèse (Mn) en une quantité comprise entre 0 et 2 % en poids au total; le scandium (Sc) en une quantité comprise entre 0 et 15 % en poids; l'indium (In) en une quantité comprise entre 0 et 15 % en poids; le calcium (Ca) en une quantité comprise entre 0 et 3 % en poids; et une ou plusieurs terres rares et des terres rares autres que l'yttrium (Y), le néodyme (Nd), l'erbium (Er), l'holmium (Ho), le lutétium (Lu), le thulium (Tm), le terbium (Tb), le dysprosium (Dy) et le gadolinium (Gd) en une quantité totale allant jusqu'à 0,5 % en poids, le reste étant du magnésium et des impuretés inévitables jusqu'à un total de 0,3 % en poids.
PCT/GB2011/050579 2010-03-25 2011-03-23 Alliage de magnésium contenant des terres rares lourdes WO2011117630A1 (fr)

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GBGB1005029.2A GB201005029D0 (en) 2010-03-25 2010-03-25 Magnesium alloys containing heavy rare earths
GB1005029.2 2010-03-25

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CN103014469A (zh) * 2013-01-08 2013-04-03 哈尔滨工程大学 一种抗冲击的高强镁合金材料及制备方法
CN103146972A (zh) * 2013-03-14 2013-06-12 河南科技大学 一种多元稀土镁合金及其制备方法
CN104651693A (zh) * 2013-11-22 2015-05-27 北京有色金属研究总院 含微量Al的稀土变形镁合金及其制备方法
CN108456815A (zh) * 2018-01-24 2018-08-28 大连理工大学 一种源自溶质均匀模型的高强高塑性Mg-Gd-Y-Zr铸造合金及其制备方法
CN108715963A (zh) * 2018-05-21 2018-10-30 山东银光钰源轻金属精密成型有限公司 一种含Y、Nd稀土镁合金及其制备方法
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