Radiopaque markers and medical devices comprising binary alloys of titanium

• US 8,500,787 B2
• Filed: 05/15/2008
• Issued: 08/06/2013
• Est. Priority Date: 05/15/2007
• Status: Expired due to Fees

• Current Assignee: Abbott Laboratories
• Original Assignee: Abbott Laboratories
• Inventors: Simpson, John A., Boylan, John F., Cornish, Wayne E.
• Primary Examiner(s): Jackson, Gary
• Assistant Examiner(s): Hollm, Jonathan
• Application Number:
  US12/153,254
• Publication Number:
  US 20090099645A1
• Time in Patent Office: 1,909 Days
• Field of Search: 606/108, 623/1.11, 623/1.15, 623/1.34, 228/196, 228/197, 228/119, 420/417, 428/656, 428/660, 428/661, 428/637, 148/669
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

There is disclosed medical devices, such as stents, guidewires and embolic filters, comprising a binary alloy of titanium and one binary element selected from platinum, palladium, rhodium, and gold. There is also disclosed a radiopaque marker comprising the disclosed binary alloy, as well as medical devices having the radiopaque marker attached thereto. Methods of attaching the radiopaque marker to the medical devices, such as by welding, are also disclosure also disclosed.

Claims

1. A medical device, comprising:

an implantable body comprising a superelastic NiTi alloy;

a radiopaque marker, said radiopaque marker comprising a binary alloy of titanium and one binary element selected from platinum, palladium, rhodium, and gold, the titanium present in an amount ranging from 45 to 55 atomic percent and the balance of the binary alloy comprising said binary element, wherein the binary alloy is processed to exhibit a yield stress of about 200 ksi to about 250 ksi; and

an autogenous weld joining the radiopaque marker and the implantable body together,

wherein the implantable body, the radiopaque marker, and the autogenous weld exhibit a crystalline lattice that is substantially the same, allowing Ni of the Ni—

Ti alloy and the binary element of the radiopaque marker to substitute for one another in one or more of the autogenous weld, in the implantable body adjacent to the autogenous weld, and in the radiopaque marker, and

wherein the implantable body, the radiopaque marker, and the autogenous weld are substantially free of brittle intermetallic compounds such that the Ni—

Ti superelastic alloy, the radiopaque marker, and the autogenous weld each maintain similar ductility.

2. The medical device of claim 1, wherein titanium is present in an amount ranging from 49 to 51 atomic percent, with the balance comprising said binary element.

3. The medical device of claim 2, wherein the binary titanium alloy comprises equiatomic binary alloys chosen from Ti50Pt50, Ti50Pd50, Ti50Rh50, and Ti50Au50.

4. The medical device of claim 1, wherein said superelastic alloy comprises a binary nickel-titanium alloy or a ternary alloy of nickel and titanium.

5. The medical device of claim 4, wherein said ternary alloy of nickel and titanium comprises at least one ternary element chosen from platinum, palladium, gold and rhodium.

6. The medical device of claim 5, wherein the superelastic alloy is a ternary alloy of nickel, titanium, and platinum.

7. The medical device of claim 6, wherein the ternary alloy comprises 49 to 51 atomic percent titanium, 7 to 8 atomic percent platinum, the remainder comprising nickel.

8. The medical device of claim 1, wherein said superelastic alloy is expandable or self-expandable.

9. The medical device of claim 1, wherein the implantable body is a stent, guidewire, or embolic protection device.

10. The medical device of claim 1, wherein the binary alloy is processed to exhibit an elastic strain limit of about 1 percent to about 3 percent.

32. The medical device of claim 1, wherein the crystalline lattice is a B2 crystalline lattice.

11. A stent comprising:

an expandable or self-expanding NiTi alloy stent body; and

a radiopaque marker integrally attached to said expandable or self-expanding stent body by an autogenous weld, wherein said radiopaque marker comprises a binary alloy of titanium and one binary element selected from platinum, palladium, rhodium, and gold, the titanium present in an amount ranging from 45 to 55 atomic percent and the balance of the binary alloy comprising said binary element, wherein the binary alloy is processed to exhibit a yield stress of about 200 ksi to about 250 ksi,

wherein the stent body, the radiopaque marker, and the autogenous weld exhibit substantially the same crystalline lattice, allowing Ni of the Ni—

Ti alloy and the binary element of the radiopaque marker to substitute for one another in one or more of the autogenous weld, in the implantable body adjacent to the autogenous weld, and in the radiopaque marker such that the Ni—

Ti superelastic alloy, the radiopaque marker, and the autogenous weld each maintain similar ductility, and

wherein the implantable body, the radiopaque marker, and the autogenous weld are substantially free of brittle intermetallic compounds such that the Ni—

Ti superelastic alloy, the radiopaque marker, and the autogenous weld each maintain similar ductility.

12. The stent of claim 11, wherein titanium is present in an amount ranging from 49 to 51 atomic percent, with the balance comprising said binary element.

13. The stent of claim 12, wherein the binary titanium alloy comprises equiatomic binary alloys chosen from Ti50Pt50, Ti50Pd50, Ti50Rh50, and Ti50Au50.

14. The stent of claim 11, wherein said expandable or self-expanding stent body comprises a binary nickel-titanium alloy or a ternary alloy of nickel and titanium.

15. The stent of claim 14, wherein said ternary alloy of nickel and titanium comprises at least one ternary element chosen from platinum, palladium, gold and rhodium.

16. The stent of claim 11, wherein said ternary alloy of nickel and titanium comprises platinum.

17. The stent of claim 16, wherein the ternary alloy comprises 49 to 51 atomic percent titanium, 7 to 8 atomic percent platinum, the remainder comprising nickel.

18. A stent delivery system including the stent of claim 11, and further comprising a guidewire.

19. The stent delivery system of claim 18, wherein said guidewire has a radiopaque marker attached thereto by an autogenous weld.

20. The stent of claim 11, wherein the binary alloy is processed to exhibit an elastic strain limit of about 1 percent to about 3 percent.

21. The medical device of claim 11, wherein the stent body, the radiopaque marker, and the autogenous weld exhibit a B2 crystalline lattice.

22. The medical device of claim 11, wherein the autogenous weld includes at least a partial intermixture of metals from the implantable body and the radiopaque marker and wherein the each of the implantable body, the radiopaque marker, and the autogenous weld exhibit a B2 crystalline lattice.

23. A method of fabricating a medical device comprising a radiopaque marker, said method comprising:

autogenously welding to an expandable or self-expanding NiTi alloy section of the medical device, the radiopaque marker comprising a binary alloy of titanium and one binary element selected from platinum, palladium, rhodium, and gold, the titanium present in an amount ranging from 45 to 55 atomic percent and the balance of the binary alloy comprising said binary element, the binary alloy exhibiting a cold-work induced yield stress of about 200 ksi to about 250 ksi,

wherein each of the expandable or self-expanding section of the medical device, the radiopaque marker, and an autogenous weld coupling the expandable or self-expanding section of the medical device to the radiopaque marker exhibit a metallurgically compatible crystalline lattice, allowing Ni of the Ni—

Ti alloy and the binary element of the radiopaque marker to substitute for one another in one or more of the autogenous weld, in the implantable body adjacent to the autogenous weld, and in the radiopaque marker, and

wherein each of the expandable or self-expanding section of the medical device, the radiopaque marker, and an autogenous weld are substantially free of brittle intermetallic compounds such that the Ni—

Ti superelastic alloy, the radiopaque marker, and the autogenous weld each maintain similar ductility.

24. The method of claim 23, wherein titanium is present in an amount ranging from 49 to 51 atomic percent, with the balance comprising said binary element.

25. The method of claim 24, wherein the binary titanium alloy comprises equiatomic binary alloys chosen from Ti50Pt50, Ti50Pd50, Ti50Rh50, and Ti50Au50.

26. The method of claim 23, wherein said autogenously welding comprises fusion welding.

27. The method of claim 23, wherein said expandable or self-expanding section comprises a binary of nickel-titanium or a ternary alloy of nickel and titanium.

28. The method of claim 27, wherein said ternary alloy of nickel and titanium comprises at least one ternary element chosen from platinum, palladium, gold and rhodium.

29. The method of claim 28, wherein said ternary alloy of nickel and titanium comprises platinum.

30. The method of claim 29, wherein the ternary alloy comprises 49 to 51 atomic percent titanium, 7 to 8 atomic percent platinum, the remainder comprising nickel.

31. The method of claim 23, wherein said medical device is chosen from a stent, guidewire, or embolic protection device.

33. The method of claim 23, wherein the metallurgically compatible crystalline lattice includes a B2 crystalline lattice.