Composite material endoprosthesis

• US 6,027,528 A
• Filed: 03/30/1998
• Issued: 02/22/2000
• Est. Priority Date: 05/28/1996
• Status: Expired due to Term

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Cottone, Robert J. Jr., Barchi, John L., Tomonto, Charles V.
• Primary Examiner(s): Willse, David H.
• Assistant Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US09/050,217
• Time in Patent Office: 694 Days
• Field of Search: 623/1, 623/12
• US Class Current: 623/1.49
• 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 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. The endoprosthesis may have a yield strength not greater than 100,000 psi. The endoprosthesis may be in the form of a wire or a tube. In one embodiment the first material is present in an amount not greater than 9% by volume based on the combined volume of the first and second materials. In another embodiment, about 30 to about 40% by volume of the first material is present based on a combined volume of the first and second materials in an endoprosthesis of tubular form.

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 yield strength not greater than 100,000 pounds per square inch.

2. The endoprosthesis of claim 1 wherein the endoprosthesis has 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 wherein said first material comprises the core and said second material comprises the tubular member.

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

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

8. The endoprosthesis of claim 1 wherein said second material is selected from the group consisting of carbon, manganese, silicon, chromium, nickel, phosphorus, sulfur, iron, alloys thereof and any combination thereof.

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

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

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

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

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

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

15. The endoprosthesis of claim 1 wherein said body structure is tubular and an inner annular layer of said body structure forms an opening for expanding and collapsing the endoprosthesis.

16. An endoprosthesis including a body structure formed of a biocompatible material, said body structure being in the form of a wire comprising 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.

17. The endoprosthesis of claim 16 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.

18. The endoprosthesis of claim 16 wherein said second material is selected from the group consisting of carbon, manganese, silicon, phosphorus, sulfur, chromium, nickel, molybdenum, iron, titanium, cobalt, alloys thereof and any combination thereof.

19. The endoprosthesis of claim 16 wherein the endoprosthesis has a yield strength not greater than 100,000 pounds per square inch.

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

21. The endoprosthesis of claim 16 wherein said body structure is tubular and an annular layer of said body structure forms an opening for expanding the endoprosthesis.

22. An endoprosthesis including a body structure formed of a biocompatible material, said body structure being in the form of a wire comprising 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.

23. The endoprosthesis of claim 22 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.

24. The endoprosthesis of claim 22 wherein said first material comprises the core and said second material comprises the tubular member.

25. The endoprosthesis of claim 22 wherein said second material is selected from the group consisting of carbon, manganese, silicon, phosphorus, sulfur, chromium, nickel, molybdenum, iron, titanium, cobalt, alloys thereof and any combination thereof.

26. The endoprosthesis of claim 22 wherein the endoprosthesis has a yield strength not greater than 100,000 pounds per square inch.

27. The endoprosthesis of claim 22 wherein said first material is selected from the group consisting of gold, platinum, tantalum, iridium, tungsten, alloys thereof, and any combination thereof.

28. An endoprosthesis including a tubular body structure formed of a biocompatible material, an annular layer of said body structure forming an opening for receiving a member for expanding the endoprosthesis, wherein said body structure comprises 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 in a range of from about 30 to about 40% 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.

29. The endoprosthesis of claim 28 wherein the endoprosthesis has a yield strength not greater than 100,000 pounds per square inch.

30. The endoprosthesis of claim 28 wherein the endoprosthesis has a hoop strength of at least 6 pounds per square inch.

31. The endoprosthesis of claim 28 wherein said body structure is comprised of at least two generally annular layers.

32. The endoprosthesis of claim 31 wherein one of said first material and said second material comprises one of said layers and the other of said first material and said second material comprises another one of said layers.

33. The endoprosthesis of claim 28 wherein said body structure comprises an outer generally annular layer, an inner generally annular layer and an intermediate generally annular layer disposed between said outer layer and said inner layer, wherein one of said first and second materials comprises the intermediate layer and the other of said first and second materials comprises at least one of the outer layer and the inner layer.

34. The endoprosthesis of claim 33 wherein said first material comprises said intermediate layer and said second material comprises at least one of said inner layer and said outer layer.

35. The endoprosthesis of claim 31 wherein each of said layers has a wall thickness ranging from about 0.0005 to about 0.0030 inches.

36. The endoprosthesis of claim 33 wherein each of said layers has a wall thickness ranging from about 0.0005 to about 0.0030 inches.

37. The endoprosthesis of claim 28 wherein said first material is selected from the group consisting of gold, platinum, tantalum, iridium, tungsten, alloys thereof, and any combination thereof.

38. The endoprosthesis of claim 28 wherein said second material is nonmagnetic.

39. The endoprosthesis of claim 28 wherein said second material is selected from the group consisting of carbon, manganese, silicon, chromium, nickel, phosphorus, sulfur, molybdenum, titanium, cobalt, iron, alloys thereof and any combination thereof.

40. The endoprosthesis of claim 28 wherein said second material comprises a cobalt alloy.

41. The endoprosthesis of claim 28 comprising at least one opening formed in a wall of said body structure to facilitate expansion and collapse of said body structure.

42. 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 controlled mass absorption coefficient effective to provide radiographic contrast corresponding to 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, wherein said mass absorption coefficient is controlled by selecting the volume of said first material and said second material and a size of said endoprosthesis, effective to provide the endoprosthesis with said radiographic contrast range of 1e^-2 to 1e^-4, wherein the endoprosthesis has a yield strength not greater than 100,000 pounds per square inch.

43. An endoprosthesis including a tubular body structure formed of a biocompatible material, an annular layer of said body structure forming an opening for receiving a member for expanding the endoprosthesis, wherein said body structure comprises 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 in a range of from about 30 to about 40% by volume based on a combined volume of said first material and said second material, wherein said body structure has a controlled mass absorption coefficient effective to provide a radiographic contrast corresponding to 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, wherein said mass absorption coefficient is controlled by selecting the volume of said first material and said second material and a size of said endoprosthesis, effective to provide the endoprosthesis with said radiographic contrast range of 1e^-2 to 1e^-4.

44. The endoprosthesis of claim 43 wherein said body structure is comprised of at least two generally annular layers.

45. The endoprosthesis of claim 44 wherein said opening is a central opening that extends along a length of the endoprosthesis.

46. The endoprosthesis of claim 44 wherein one of said first material and said second material comprises one of said layers and the other of said first material and said second material comprises another of said layers.

47. The endoprosthesis of claim 46 wherein each of said layers has a wall thickness ranging from about 0.0005 to about 0.0030 inches.

48. The endoprosthesis of claim 45 comprising at least one opening formed in a wall of said body structure to facilitate expansion and collapse of said body structure.

49. An endoprosthesis including a tubular body structure formed of a biocompatible material, an annular layer of said body structure forming an opening for receiving a member for expanding the endoprosthesis, wherein said body structure comprises 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 of 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 controlled mass absorption coefficient effective to provide a radiographic contrast corresponding to 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, wherein said mass absorption coefficient is controlled by selecting the volume of said first material and said second material and a size of said endoprosthesis, effective to provide the endoprosthesis with said radiographic contrast range of 1e^-2 to 1e^-4.

50. The endoprosthesis of claim 49 wherein said body structure is comprised of at least two generally annular layers.

51. The endoprosthesis of claim 49 wherein said opening is a central opening that extends along a length of the endoprosthesis.

52. The endoprosthesis of claim 50 wherein one of said first material and said second material comprises one of said layers and the other of said first material and said second material comprises another of said layers.

53. The endoprosthesis of claim 49 comprising at least one opening formed in a wall of said body structure to facilitate expansion and collapse of said body structure.