Tubular medical endoprostheses

• US 6,290,721 B1
• Filed: 10/21/1997
• Issued: 09/18/2001
• Est. Priority Date: 03/31/1992
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Corporation
• Inventors: Heath, Kevin R.
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): Phan, Hieu
• Application Number:
  US08/955,268
• Time in Patent Office: 1,428 Days
• Field of Search: 623/1, 623/12, 623/1-5-, 606/195, 606/198
• US Class Current: 623/1.15
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2210/0019 operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• 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 31/022 Metals or alloys
• CPC Class Codes: A61L 31/088 Other specific inorganic materials not covered by A61L31/084 or A61L31/086
• CPC Class Codes: A61L 31/18 Materials at least partially X-ray or laser opaque
• CPC Class Codes: A61M 2025/09166 having radio-opaque features
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers

Abstract

A tubular prosthesis device for use within the body. The device includes, a metal filament material formed of metal outer member having an exposed outer surface and a core within the extended outer member formed of a different metal than the outer member. The core is secured within and substantially enclosed by the outer member. The device can be reduced to a small size for introduction into the body lumen and expandable to a sufficiently large size to engage the wall of the body lumen. Stents formed of composite wires are shown.

Claims

1. A tubular prosthesis device for use within the body comprised at least in part of an elongated filament-form metal element adapted to be subjected to elastic deformation to enable the device to be forced into a characteristic deformed configuration during a stage of use and to elastically self-recover from said deformation when deformation forces are relieved, said filament-form metal element comprised of a core of a first metal of a first selected thickness and an intimately surrounding sheath of a second selected metal of a second thickness, said first metal being of a substantially higher radiopacity than that of said second metal, said second metal being substantially more elastic than said first metal, the metals in said filament-form metal element serving to enhance the radiopacity of said filament-form metal element to provide improved fluoroscopic or x-ray visualization of said filament-form metal element in said body while imparting sufficient elasticity to enable the filament-form metal element to elastically self-recover from said characteristic deformed configuration.

2. The device of claim 1, wherein said filament-form metal element is the product produced by draw-forming.

3. The device of claim 1, wherein said second metal is nitinol.

4. The device of claim 3, wherein said high density metal is tantalum.

5. The device of claim 1, wherein said tubular prosthetic device is formed into said tubular shape by knitting into loosely interlocked loops of said filament-form metal element.

6. The device of claim 1, wherein the transverse cross-sectional dimension of said filament-form metal element is about no greater than 0.015 inch.

7. The device of claim 1, wherein said transverse cross-sectional dimension of said filament-form metal is about 0.0045 to about 0.006 inch and said core has a transverse cross-sectional dimension of about 0.0014 to about 0.00195 inch.

8. The device of claim 1, wherein said core has a density of about at least 9.9 g/cc.

9. The device of claim 8, wherein said core is selected from the group consisting of tungsten, tantalum, rhenium, iridium, silver, gold, bismuth and platinum.

10. The device of claim 1, wherein said outer member is selected from superelastic alloys and precursors of superelastic alloys.

11. The device of claim 10, wherein said outer member is nitinol.

12. The device of claim 11, wherein said core is tantalum.

13. The device of claim 1, wherein a transverse cross-sectional dimension of said core is about 1 to 40% of a transverse cross-sectional dimension of said filament-form metal element.

14. The device of claim 13, wherein said core is about 25 to 40% of a transverse cross-sectional dimension of said filament-form metal element.

15. The device of claim 13, wherein said core is about 33% of a transverse cross-sectional dimension of said filament-form metal element.

16. The device of claim 1, wherein said core has a modulus of elasticity of about no greater than 500 GPa.

17. The device of claim 1, wherein said core has a modulus of elasticity of about no greater than 200 GPa.

18. The device of claim 1, wherein said filament-form metal element has a transverse cross-sectional dimension of less than about 0.0075 inch.

19. The device of claim 1, wherein said filament-form metal element has a transverse cross-sectional dimension of about 0.0045 inch to about 0.006 inch.

20. The device of claim 1, wherein said stent device has a diameter of about 4 mm to about 12 mm.

21. The device of claim 1, wherein said stent device has a length of about 2 cm to about 8 cm.

22. The device of claim 1, wherein said filament-form metal element is in an overlapping pattern.

23. The device of claim 1, wherein said stent device is a weave of said filament-form metal element.

24. The device of claim 1 or 18-23, wherein said first metal is tantalum.

25. A tubular prosthesis for use within the body comprised at least in part of an elongated filament-form metal element, said filament-form metal element being arranged in an overlapping pattern defining a tube and adapted to be subjected to elastic deformation to enable the device to be forced into a characteristic deformed configuration during a stage of use and to elastically self-recover from said deformation when deformation forces are relieved, said filament-form metal element having transverse cross-sectional dimension of about 0.0075 inch or less and being comprised of a core of a first metal of a first selected thickness and an intimately surrounding sheath of a second selected metal of a second thickness, said first metal being tantalum and having a substantially higher density and demonstrating characteristically substantially higher radiopacity than that of said second metal, said second metal being substantially more elastic than said first metal, the combined effect of said first and second metals in said filament-form metal element to provide improved fluoroscopic or x-ray visualization of said filament-form metal element in said body while imparting sufficient elasticity to enable the filament-form metal element to elastically self-recover from said characteristic deformed configuration.

26. An implantable tubular medical stent, comprising:

a metal wire composed of multiple metal layers, including a first layer formed of a first metal and a second layer formed of a second metal, the first metal having a greater density than the second metal and the first layer being disposed inwardly of the second layer.

27. The implantable tubular stent of claim 26, wherein the wire is formed by draw-forming.

28. The implantable tubular stent of claim 26, wherein the second metal is nitinol.

29. The implantable tubular stent of claim 28, wherein the first metal is tantalum.

30. The implantable tubular stent of claim 26, wherein the stent is formed by knitting, weaving or crocheting the wire.

31. The implantable tubular stent of claim 26, wherein the wire has an overall diameter of no greater than about 0.015 inch.

32. The implantable tubular stent of claim 26, wherein the first metal has a density of at least about 9.9 g/cc.

33. The implantable tubular stent of claim 26, wherein the first metal is selected from the group consisting of stainless steel, tantalum, rhenium, iridium, silver, gold, bismuth and platinum.

34. The implantable tubular stent of claim 26, wherein the second metal is selected from the group consisting of stainless steel, superelastic alloys and precursors of superelastic alloys.

35. The implantable tubular stent of claim 26, wherein the second metal is nitinol.

36. The implantable tubular stent of claim 35, wherein the first metal is tantalum.

37. The implantable tubular stent of claim 26, wherein the core has a diameter of about 1 to 40% of an overall diameter of the wire.

38. The implantable tubular stent of claim 37, wherein the wire has an overall diameter of about 0.0045 to 0.006 inch and the core has a diameter of about 0.0014 to 0.00195 inch.

39. The implantable tubular stent of claim 37, wherein the core has a diameter of about 25% to 40% of the overall diameter of the wire.

40. The implantable tubular stent of claim 39, wherein the core is about 33% of the overall diameter of the wire.

41. The implantable tubular stent of claim 26, wherein the first metal has a modulus of elasticity of no greater than about 500 GPa.

42. The implantable tubular stent of claim 41, wherein the first metal has a modulus of elasticity of no greater than about 200 GPa.

43. The implantable tubular stent of claim 26, wherein the stent has a length in the range of about 2-8 cm.

44. The implantable tubular stent of claim 43, wherein the stent has a diameter in the range of about 4-12 mm.

45. An implantable tubular medical stent, comprising:

a metal wire composed of multiple metal layers, including a first layer formed of a first metal and a second layer formed of a second metal, the first metal having a greater density than the second metal and being selected from the group consisting of tantalum, platinum, tungsten and iridium, the first layer being disposed inwardly of the second layer.

46. The implantable tubular stent of claim 45, wherein the first metal is tantalum.

47. The implantable tubular stent of claim 45, wherein the core has a diameter greater than about 1% of an overall diameter of the wire.

48. The implantable tubular stent of claim 47, wherein the core has a diameter of about 50% or less of the overall diameter of the wire.

49. The implantable tubular stent of claim 45, wherein the second metal is selected from the group consisting of stainless steel, superelastic alloys and precursors of superelastic alloys.

50. The implantable tubular stent of claim 45, wherein the stent has a length of about 2-8 cm and a diameter in the range of about 4-12 mm.

51. The implantable tubular stent of claim 45, where in the wire has a diameter of about 0.0075 inch or less.

52. The implantable tubular stent of claim 46, where in the wire has a diameter of about 0.0075 inch or less.

53. The implantable tubular stent of claim 47, where in the wire has a diameter of about 0.0075 inch or less.

54. The implantable tubular stent of claim 48, where in the wire has a diameter of about 0.0075 inch or less.

55. The implantable tubular stent of claim 49, where in the wire has a diameter of about 0.0075 inch or less.