Composite material endoprosthesis

• US 5,733,326 A
• Filed: 05/28/1996
• Issued: 03/31/1998
• Est. Priority Date: 05/28/1996
• Status: Expired due to Term

• Current Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Tomonto, Charles V., Cottone, Robert J. Jr., Barchi, John L.
• Primary Examiner(s): Weiss, John G.
• Assistant Examiner(s): Black, John M.
• Application Number:
  US08/654,165
• Time in Patent Office: 672 Days
• Field of Search: 623/1, 623/11, 623/12, 606/194, 606/195, 606/198
• US Class Current: 623/1.44
• CPC Class Codes: A61F 2/01 Filters implantable into blood vessels
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• 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: A61L 27/04 Metals or alloys
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 31/022 Metals or alloys
• CPC Class Codes: A61L 31/024 Carbon; Graphite
• CPC Class Codes: A61L 31/028 Other inorganic materials not covered by A61L31/022 - A61L31/026
• CPC Class Codes: A61L 31/14 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 31/18 Materials at least partially X-ray or laser opaque

Abstract

An endoprosthesis includes a body structure formed of a biocompatible material, the body structure including a first material having an average atomic number greater than 24 and a second material that is different than the first material. The first material is present in an amount not greater than 9% by volume based on the combined volume of the first material and the second material. The body structure has a mass absorption coefficient effective to provide a ratio of an intensity of an incident X-ray to an intensity of a transmitted X-ray in a range of 1e^-2 to 1e^-4.

Claims

1. An endoprosthesis including a body structure formed of a biocompatible material, said body structure including a first material having an average atomic number greater than 24 and a second material that is different than said first material, said first material being present in an amount not greater than 9% by volume based on a combined volume of said first material and said second material, wherein said body structure has a mass absorption coefficient effective to provide a ratio of an intensity of an incident X-ray to an intensity of a transmitted X-ray in a range of 1e^-2 to 1e^-4 and wherein the endoprosthesis has a tensile strength ranging from 80,000-140,000 pounds per square inch.

2. The endoprosthesis of claim 1 the endoprosthesis having a hoop strength of at least 6 pounds per square inch.

3. The endoprosthesis of claim 1 wherein said body structure comprises an elongated central cylindrical core and an elongated outer tubular member disposed around the core, one of said first and second materials comprising the core and the other of said first and second materials comprising the tubular member.

4. The endoprosthesis of claim 1 wherein said body structure comprises at least one layer, a first layer of said body structure being comprised of said first material and a second layer of said body structure being comprised of said second material.

5. The endoprosthesis of claim 3 said first material comprising the core and said second material comprising the tubular member.

6. The endoprosthesis of claim 1 said first material being selected from the group consisting of gold, platinum, tantalum, iridium, tungsten, and alloys thereof, and any combination thereof.

7. The endoprosthesis of claim 1 said second material comprising a nonmagnetic material.

8. The endoprosthesis of claim 1 said second material comprising carbon, manganese, silicon, chromium, nickel, phosphorus, sulfur and iron.

9. The endoprosthesis of claim 1 said second material comprising a cobalt alloy.

10. The endoprosthesis of claim 9 said second material being selected from the group consisting of carbon, manganese, silicon, phosphorus, sulfur, chromium, nickel, molybdenum, iron, titanium, and cobalt, and any combination thereof.

11. The endoprosthesis of claim 5 the tubular member having an outer diameter ranging from 0.0020 to 0.0150 inches.

12. The endoprosthesis of claim 5 the tubular member having an outer diameter ranging from 0.0040 to 0.0100 inches.

13. The endoprosthesis of claim 5 the tubular member having an outer diameter ranging from 0.0050 to 0.0075 inches.

14. The endoprosthesis of claim 5 the core having a diameter ranging from 0.0005 to 0.0030 inches.

38. The endoprosthesis of claim 4 wherein the endoprosthesis is configured and arranged as a tube having a wall comprising said first layer and said second layer, each layer of said body structure having a generally annular shape.

39. The endoprosthesis of claim 38 wherein a wall thickness of said tube ranges from 0.0020 to 0.0150 inches.

40. The endoprosthesis of claim 38 wherein a wall thickness of said tube ranges from 0.0040 to 0.0100 inches.

41. The endoprosthesis of claim 38 wherein a wall thickness of said tube ranges from 0.0050 to 0.0075 inches.

42. The endoprosthesis of claim 38 wherein said first layer has a thickness ranging from 0.0005 to 0.0030 inches.

15. An endoprosthesis including a body structure formed of a biocompatible material, said body structure being in the form of a wire comprising a central cylindrical core and an outer sheath disposed around said core, said core including a first material having an average atomic number greater than 24 and said sheath including a second material that is different than said first material, said first material being present in an amount not greater than 9% by volume based on a combined volume of said first material and said second material, and wherein said body structure has a mass absorption coefficient effective to provide a ratio of an intensity of an incident X-ray to an intensity of a transmitted X-ray in a range of 1e^-2 to 1e^-4 and wherein the endoprosthesis has a tensile strength ranging from 80,000 to 140,000 pounds per square inch.

16. The endoprosthesis of claim 15 said first material being selected from the group consisting of gold, platinum, tantalum, iridium, tungsten, and alloys thereof, and any combination thereof.

17. The endoprosthesis of claim 15 said second material comprising a cobalt alloy.

18. The endoprosthesis of claim 15 the tubular member having an outer diameter ranging from 0.0020 to 0.0150 inches.

19. The endoprosthesis of claim 15 the tubular member having an outer diameter ranging from 0.0040 to 0.0100 inches.

20. The endoprosthesis of claim 15 the tubular member having an outer diameter ranging from 0.0050 to 0.0075 inches.

21. The endoprosthesis of claim 15 the core having an outer diameter ranging from 0.0005 to 0.0030 inches.

22. The endoprosthesis of claim 15 the endoprosthesis having a hoop strength of at least about 6 pounds per square inch.

37. The endoprosthesis of claim 15 said second material being selected from the group consisting of carbon, manganese, silicon, phosphorus, sulfur, chromium, nickel, molybdenum, iron, titanium, and cobalt, and any combination thereof.

23. An endoprosthesis including a body structure formed of a biocompatible material, said body structure including a first material having an average atomic number greater than 24 and a second material that is different than said first material, said first material being present in an amount not greater than 7% by volume based on a combined volume of said first material and said second material, and wherein said body structure has a mass absorption coefficient effective to provide a ratio of an intensity of an incident X-ray to an intensity of a transmitted X-ray in a range of 1e^-2 to 1e^-4.

24. The endoprosthesis of claim 23 said body structure comprising an elongated central cylindrical core and an elongated outer tubular member disposed around the core, one of said first and second materials comprising the core and the other of said first and second materials comprising the tubular member.

25. The endoprosthesis of claim 23 said body structure comprising at least one layer, one of said first and second materials comprising one said layer and the other of said first and second materials comprising another said layer.

26. The endoprosthesis of claim 24 said first material comprising the core and said second material comprising the tubular member.

27. The endoprosthesis of claim 23 said second material being selected from the group consisting of carbon, manganese, silicon, phosphorus, sulfur, chromium, nickel, molybdenum, iron, titanium, and cobalt, and any combination thereof.

28. The endoprosthesis of claim 23 the endoprosthesis having a tensile strength ranging from 80,000-140,000 pounds per square inch.

29. The endoprosthesis of claim 23 said first material being selected from the group consisting of gold, platinum, tantalum, iridium, tungsten, and alloys thereof, and any combination thereof.

30. An endoprosthesis including a body structure formed of a biocompatible material, said body structure including a first material having an average atomic number greater than 24 and a second material that is different than said first material and nonmagnetic, said first material being present in an amount not greater than 9% by volume based on a combined volume of said first material and said second material, and wherein said body structure has a mass absorption coefficient effective to provide a ratio of an intensity of an incident X-ray to an intensity of a transmitted X-ray in a range of 1e^-2 to 1e^-4.

31. The endoprosthesis of claim 30 said body structure comprising an elongated central cylindrical core and an elongated outer tubular member disposed around the core, one of said first and second materials comprising the core and the other of said first and second materials comprising the tubular member.

32. The endoprosthesis of claim 30 said body structure comprising at least one layer, one of said first and second materials comprising one said layer and the other of said first and second materials comprising another said layer.

33. The endoprosthesis of claim 31 said first material comprising the core and said second material comprising the tubular member.

34. The endoprosthesis of claim 30 said second material being selected from the group consisting of carbon, manganese, silicon, phosphorus, sulfur, chromium, nickel, molybdenum, iron, titanium, and cobalt, and any combination thereof.

35. The endoprosthesis of claim 30 the endoprosthesis having a tensile strength ranging from 80,000-140,000 pounds per square inch.

36. The endoprosthesis of claim 30 said first material being selected from the group consisting of gold, platinum, tantalum, iridium, tungsten, and alloys thereof, and any combination thereof.