Bioerodible magnesium alloy microstructures for endoprostheses

Patent metadata

Field	Value
Publication number	US-9522220-B2
Application number	US-201414527317-A
Country	US
Kind code	B2
Filing date	Oct 29, 2014
Priority date	Oct 29, 2013
Publication date	Dec 20, 2016
Grant date	Dec 20, 2016

Abstract

A bioerodible endoprosthesis includes a bioerodible magnesium alloy including between 50 weight percent and 92 weight percent magnesium, at least 5.5 weight percent in sum of one or more elements selected from the group consisting of Ho, Er, Lu, Tb and Tm, and at least 2.0 weight percent in sum of one or more elements selected from the group consisting of Y, Nd and Gd. The bioerodible magnesium alloy has a microstructure including equiaxed Mg-rich solid solution-phase grains having an average grain diameter of less than or equal to 15 microns and second-phase precipitates and/or ceramic nanoparticles in grain boundaries between the equiaxed Mg-rich solid solution-phase grains. The secondary-phase precipitates or ceramic nanoparticles have an average longest dimension of 2.0 micron or less. The microstructure can be produced by one or more equal-channel high-strain processes.

First claim

What is claimed is:

1. A bioerodible endoprosthesis comprising:
a bioerodible magnesium alloy comprising:
between 50 weight percent and 92 weight percent magnesium,
at least 5.5 weight percent in sum of one or more elements selected from the group consisting of Ho, Er, Lu, Tb and Tm; and
at least 2.0 weight percent in sum of one or more elements selected from the group consisting of Y, Nd and Gd;

the bioerodible magnesium alloy having a microstructure comprising equiaxed Mg-rich solid solution phase grains having an average grain diameter of less than or equal to 15 microns; and
continuous or discontinuous second-phase precipitates or ceramic nanoparticles in grain boundaries between the Mg-rich solid solution-phase grains, the second-phase precipitates or ceramic nanoparticles having an average longest dimension of 2.0 micron or less.

2. The endoprosthesis of claim 1 , wherein the second-phase precipitates or ceramic nanoparticles are primarily centered upon the gran boundaries and do not extend into a Mg-rich solid solution phase grain interior by more than 1 micron from the grain boundary when viewed at 200-500× magnification on a metallography plane.

3. The endoprosthesis of claim 1 , wherein the equiaxed Mg-rich solid solution phase grains have an average grain diameter of less than or equal to 1 micron and the second-phase precipitates or ceramic nanoparticles have an average longest dimension of between 0.5 nanometer and 200 nanometers.

4. The endoprosthesis of claim 1 , wherein less than 50% of the equiaxed Mg-rich solid solution-phase grains have twin bands.

5. The endoprosthesis of claim 4 , wherein less than 15% of the equiaxed Mg-rich solid solution-phase grains have twin bands.

6. The endoprosthesis of claim 1 , wherein the bioerodible magnesium alloy includes secondary-phase precipitates outside the grain boundaries, wherein at least 50% of the total amount of secondary-phase precipitates are located in grain boundaries between the equiaxed Mg-rich solid solution-phase grains.

7. The endoprosthesis of claim 1 , wherein the endoprosthesis comprises the ceramic nanoparticles and the ceramic nanoparticles are insoluble in the bioerodible magnesium alloy.

8. The endoprosthesis of claim 7 , wherein the ceramic nanoparticles comprise a ceramic material selected from the group consisting of TiC, Si 3 N 4 , AlN, Al 2 O 3 , CeO 2 , Boron Nitride, B 4 C, Y 2 O 3 , and combinations thereof.

9. The endoprosthesis of claim 1 , wherein the alloy has an elastic modulus of between 39 GPa and 200 GPa, a 0.2% offset yield strength of between 150 MPa and 600 MPa, an ultimate tensile strength of between 250 MPa and 600 MPa, and a tensile reduction in area of at least 30%.

10. The endoprosthesis of claim 1 , wherein the bioerodible magnesium alloy comprises a Y content of between 0-10.0 weight percent, a Nd content of between 0-4.5 weight percent, a Gd content of between 0-9 weight percent, and a Dy content of between 0-8.0 weight percent.

11. The endoprosthesis of claim 1 , wherein the bioerodible magnesium alloy comprises a Ho content of between 4.0-15.0 weight percent.

12. The endoprosthesis of claim 1 , wherein the bioerodible magnesium alloy comprises a Er content of between 4.0-15.0 weight percent.

13. The endoprosthesis of claim 1 , wherein the bioerodible magnesium alloy comprises a Lu content of between 4.0-15.0 weight percent.

14. The endoprosthesis of claim 1 , wherein the bioerodible magnesium alloy comprises a Tm and/or Tb content of between 4.0-15.0 weight percent.

15. The endoprosthesis of claim 1 , wherein the bioerodible magnesium alloy consist of:
Y: 0-10.0 weight percent;
Nd: 0-4.5 weight percent;
Gd: 0-9.0 weight percent;
Dy: 0-8.0 weight percent;
Ho: 0-19.0 weight percent;
Er: 0-23.0 weight percent;
Lu: 0-25.0 weight percent;
Tm: 0-21.0 weight percent;
Tb: 0-21.0 weight percent;
Zr: 0.1-1.5 weight percent;
Ca: 0-2.0 weight percent;
Zn: 0-1.5 weight percent;
In: 0-12.0 weight percent;
Sc: 0-15.0 weight percent;
incidental impurities up to a total of 0.3 weight percent; and
the balance being magnesium and under the condition that a total content of Ho, Er, Lu, Tb and Tm is more than 5.5 weight percent; a total content of Y, Nd and Gd is more than 2.0 weight percent; and a total content of all alloy compounds except magnesium is more than 8.5 weight percent.

16. The endoprosthesis of claim 1 , wherein the endoprosthesis is a stent comprising a plurality of struts, wherein the struts have a width to thickness ratio of less than 1.2.

17. The endoprosthesis of claim 1 , wherein the endoprosthesis has a surface finish having an R a surface roughness of less than 0.2 microns.

Assignees

• Boston Scient Scimed Inc

Inventors

• Edick Jacob Drew

Classifications

• A61F2210/0004

  bioabsorbable · CPC title

• A61L31/022 Primary

  Metals or alloys · CPC title

• C22C23/06

  with a rare earth metal as the next major constituent · CPC title

• Y10T428/12993

  Surface feature [e.g., rough, mirror] · CPC title

• C22F1/06

  of magnesium or alloys based thereon · CPC title