Clad composite stent

• US 6,527,802 B1
• Filed: 09/23/1997
• Issued: 03/04/2003
• Est. Priority Date: 01/19/1993
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Mayer, David W.
• Primary Examiner(s): SNOW, BRUCE EDWARD
• Application Number:
  US08/935,694
• Time in Patent Office: 1,988 Days
• Field of Search: 623/1, 623/11, 623/12, 623/13, 623/16, 623/66, 623/1.49, 623/1.1, 623/1.51, 623/23.71, 606/191, 606/198, 604/96, 604/280, 128/654-657, 428/375, 428/378, 428/392, 428/457
• US Class Current: 623/1.49
• 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. Alternative composite filaments employ an intermediate barrier layer between the case and core, a biocompatible cover layer surrounding the case, and a radiopaque case surrounding a structural core.

Claims

1. A body compatible device comprising a hollow tubular body made of at least one elongate filament, the filament including an elongate core and an elongate case at least partially surrounding the core, wherein the case comprises a case material having a yield strength of at least 100,000 psi at 0.2% offset, and the core comprises a platinum-nickel alloy including from about 5 percent to about 15 percent nickel, by weight.

2. The device of claim 1 wherein the platinum-nickel alloy comprises about 10 weight percent nickel.

3. The device of claim 1 wherein the core consists essentially of said platinum-nickel alloy.

4. The device of claim 1 wherein the case and core are contiguous.

5. The device of claim 1 comprising a plurality of elongate filaments helically wound and interwoven with one another in a braided configuration.

6. An expandable stent comprising at least one elongate filament, the filament having a case made of a case material having a yield strength of at least 100,000 psi at 0.2% offset, and a core comprising a platinum-nickel alloy including from about 5 percent to about 15 percent nickel, by weight.

7. The stent of claim 6 wherein the platinum-nickel alloy comprises about 10 weight percent nickel.

8. The stent of claim 6 wherein the core consists essentially of said platinum-nickel alloy.

9. The stent of claim 6 wherein the case and core are contiguous.

10. The stent of claim 6 wherein the stent is adapted to self-expand.

11. The stent of claim 6 comprising a plurality of elongate filaments helically wound and interwoven with one another in a braided configuration.

12. A body compatible device comprising a hollow tubular body made of at least one elongate filament, the filament including an elongate core and an elongate case at least partially surrounding the core;

a) wherein the core comprises a platinum-nickel alloy and the case comprises 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; and

b) wherein the platinum-nickel alloy of the core includes from about 5 percent to about 15 percent nickel, by weight.

13. The device of claim 12 wherein the core comprises about 85-95 weight percent platinum.

14. The device of claim 13 wherein the core comprises about 90 weight percent platinum and about 10 weight percent nickel.

15. The device of claim 12 wherein the core consists essentially of about 85-95 weight percent platinum and about 5-15 weight percent nickel.

16. The device of claim 12 wherein the case and core are contiguous.

17. The device of claim 12 comprising a plurality of elongate filaments helically wound and interwoven with one another in a braided configuration.

18. An expandable stent comprising at least one elongate filament including an elongate core and an elongate case at least partially surrounding the core,

a) wherein the core comprises a platinum-nickel alloy and the case comprises 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;

and

b) wherein the platinum-nickel alloy of the core includes from about 5 percent, to about 15 percent nickel, by weight.

19. The stent of claim 18 wherein the core comprises about 85-95 weight percent platinum.

20. The stent of claim 19 wherein the core comprises about 90 weight percent platinum and about 10 weight percent nickel.

21. The device of claim 18 wherein the core consists of essentially of about 85-95 weight percent platinum and about 5-15 weight percent nickel.

22. The stent of claim 18 wherein the case and core are contiguous.

23. The stent of claim 18 comprising a plurality of elongate filaments helically wound and interwoven with one another in a braided configuration.

24. The stent of claim 18 wherein the stent is adapted to self-expand.