Clad composite stent

• US 5,630,840 A
• Filed: 06/07/1995
• Issued: 05/20/1997
• Est. Priority Date: 01/19/1993
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Schneider Electric SE
• Inventors: Mayer, David W.
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): Black, John M.
• Application Number:
  US08/483,334
• Time in Patent Office: 713 Days
• Field of Search: 623/1, 623/11, 623/12, 606/194, 606/195, 606/198
• US Class Current: 623/66.1
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2310/00029 Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
• CPC Class Codes: A61L 31/022 Metals or alloys
• CPC Class Codes: A61L 31/082 Inorganic materials
• CPC Class Codes: A61L 31/18 Materials at least partially X-ray or laser opaque
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: B21C 1/00 Manufacture of metal sheets, metal wire, metal rods, metal tubes by drawing

Abstract

A body compatible stent is formed of multiple filaments arranged in at least two sets of oppositely directed helical windings interwoven with one another in a braided configuration. Each of the filaments is a composite including a central core and a case surrounding the core. In the more preferred version, the core is formed of a radiopaque and relatively ductile material, e.g. tantalum or platinum. The outer case is formed of a relatively resilient material, e.g. a cobalt/chromium based alloy. Favorable mechanical characteristics of the stent are determined by the case, while the core enables in vivo imaging of the stent. The composite filaments are formed by a drawn filled tubing process in which the core is inserted into a tubular case of a diameter substantially more than the intended final filament diameter. The composite filament is cold-worked in several steps to reduce its diameter, and annealed between successive cold-working steps. After the final cold working step, the composite filament is formed into the desired shape and age hardened. The composite filaments employ an intermediate barrier layer between the case and core, formed for example of tantalum, niobium or platinum. To improve compatibility, a biocompatible cover layer can surround the case. An alternative composite filament features, and a radiopaque case surrounding a structural core.

Claims

1. A body compatible device comprising:

an elongate filament substantially uniform in lateral cross-section over a length or the filament comprising an elongate core and an elongate case surrounding the core substantially over said length; and

a barrier layer surrounding the core and disposed between the core and the case substantially over said length;

wherein the case is constructed of a case material having a yield strength of at least 100,000 psi at 0.2 percent offset, and the core is constructed of a core material from the group consisting of;

tantalum, a tantalum-based alloy, platinum, a platinum-based alloy, tungsten, a tungsten-based alloy, and combinations thereof.

2. The device of claim 1 wherein:

said barrier layer is constructed of a material from the group consisting of;

tantalum, niobium, platinum, and combinations thereof.

3. The device of claim 1 wherein:

said core material comprises said tantalum-based alloy, and a tantalum-based alloy comprises tungsten at about 5-20 percent by weight.

4. The device of claim 1 wherein:

said case material comprises a cobalt-based alloy.

5. The device of claim 1 wherein:

said case material comprises a titanium-based alloy.

6. The device of claim 1 wherein:

said core material comprises said platinum-based alloy, and the platinum alloy consists essentially of platinum and a material from the consisting of group;

nickel at from 5-15 percent;

iridium at from 5-50 percent; and

tungsten at about 5-15 percent.

7. The device of claim 1 wherein:

said core material comprises tungsten-based alloy, and the tungsten-based alloy comprises rhenium at 5-40 percent, by weight.

8. A body compatible device including a plurality of elongate filaments as defined in claim 1, wherein:

said elongate filaments are helically wound in at least two oppositely directed sets of spaced apart filaments, with said sets of filaments interwoven with one another in a braided configuration.

9. A body compatible device comprising:

an elongate filament substantially uniform in lateral cross-section over a length of the filament comprising an elongate core and an elongate case surrounding the core substantially over said length; and

a barrier layer surrounding the core and disposed between the core and case substantially over said length;

wherein the core is constructed of a core material having a linear attenuation coefficient of at least 25 cm^-1 at 100 KeV, and the case is constructed of a case material, said core material being more ductile and more radiopaque than the case material, and wherein the case material comprises a titanium-based alloy.

10. The device of claim 9 wherein:

said barrier layer is formed of a material from the group consisting of;

tantalum, niobium, platinum, and combinations thereof.

11. The device of claim 9 wherein:

said titanium-based alloy includes niobium at about 10-15 percent, and zirconium at about 10-15 percent, by weight.

12. The device of claim 11 wherein:

said titanium-based alloy further includes molybdenum and tin.

13. The device of claim 9 wherein:

said core material consists essentially of a material from the group consisting of;

tantalum, a tantalum-based alloy, a platinum-based alloy, and combinations thereof.

14. The device of claim 13 wherein:

said core material consists essentially of said platinum-based alloy.

15. A resilient, body implantible prosthesis including a plurality of elongate filaments as defined in claim 9, wherein:

said elongate filaments are helically wound in at least two oppositely directed sets of spaced apart filaments with said sets of filaments interwoven with one another in a braided configuration.

16. A body compatible device comprising:

an elongate filament substantially uniform in lateral cross-section over a length of the filament comprising an elongate core and an elongate case surrounding the core substantially over said length; and

a barrier layer surrounding the core and disposed between the core and the case substantially over said length;

wherein the core is formed of a core material comprising an essentially unalloyed tantalum and the case is formed of a case material comprising about 30-55 weight percent cobalt, about 15-25 weight percent chromium, about 0-40 weight percent nickel, about 5-15 weight percent molybdenum, about 0-5 weight percent manganese, and about 0-25 weight percent iron.

17. The device of claim 16 wherein:

said barrier layer is formed of a material from the group consisting of;

tantalum, niobium, and platinum.

18. A resilient, body implantible prosthesis including a plurality of elongate filaments as defined in claim 16, wherein:

said elongate filaments are helically wound in at least two oppositely directed sets of spaced apart filaments, with said sets of filaments interwoven with one another in a braided configuration.

19. A body compatible device comprising:

an elongate filament substantially uniform in lateral cross-section over a length of the filament comprising an elongate core and an elongate case surrounding the core substantially over said length; and

a barrier layer surrounding the core and disposed between the core and the case substantially over said length;

wherein the core material comprises about 85-95 weight percent platinum and about 5-15 weight percent nickel, and the case is formed of a case material comprising about 30-55 weight percent cobalt, about 15-25 weight percent chromium, about 0-40 weight percent nickel, about 5-15 weight percent molybdenum, about 0-5 weight percent manganese, and about 0-25 weight percent iron.

20. The device of claim 19 wherein:

said barrier layer is formed of a material from the group consisting of;

tantalum, niobium, platinum, and combinations thereof.

21. The device of claim 19 wherein:

said core material comprises about 10 percent nickel.

22. A resilient, body implantible prosthesis including a plurality of elongate filaments as defined in claim 19, wherein:

said elongate filaments are helically wound in at least two oppositely directed sets of spaced apart filaments, with said sets of filaments interwoven with one another in a braided configuration.