Endoluminal devices, embolic filters, methods of manufacture and use

• US 20030187495A1
• Filed: 04/01/2002
• Published: 10/02/2003
• Est. Priority Date: 04/01/2002
• Status: Abandoned Application

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Cully, Edward H., Vonesh, Michael J.
• Application Number:
  US10/113,724
• Publication Number:
  US 20030187495A1
• Time in Patent Office: Days
• US Class Current: 623/1.15
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61F 2/0105 Open ended, i.e. legs gathered only at one side
• CPC Class Codes: A61F 2/0108 Both ends closed, i.e. legs gathered at both ends
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0015 Kidney-shaped, e.g. bean-shaped
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/0076 ellipsoidal or ovoid
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2230/0093 Umbrella-shaped, e.g. mushroom-shaped

Abstract

A seamless, self-expanding implantable device having a low profile is disclosed along with methods of making and using the same. The implantable device includes a frame cut out of a single piece of material that is formed into a three-dimensional shape. The implantable device may comprise an embolic filter, stent, or other implantable structure. The present invention also allows complicated frame structures to be easily formed from planar sheets of starting material, such as through laser cutting, stamping, photo-etching, or other cutting techniques.

Claims

1. A filter comprising:

a seamless frame having a proximal end and a longitudinal axis, said frame having a seamless support member circumscribing said axis and distally spaced from said proximal end, said support member having at least one attachment strut seamlessly extending therefrom and terminating at said proximal end, and a filter media having an open, proximal end cooperating with said support member and a closed end extending distally away from said open end and defining the end of said filter.

2. The filter according to claim 1 further including at least one filter strut seamlessly extending distally from support member and having a mid-point that is distally spaced from said support member, said at least one filter strut engaging and supporting said filter media.

3. The filter according to claim 1, wherein said at least one attachment strut comprises a plurality of attachment struts each seamlessly extending from said support member and terminating at said proximal end.

4. The filter according to claim 2, wherein said at least one filter strut comprises a plurality of filter struts seamlessly extending distally away from said support member.

5. The filter according to claim 1, further including a plurality of filter struts seamlessly extending distally away from said support member.

6. The filter according to claim 2, wherein there are at least two filter struts.

7. The filter according to claim 2, wherein there are at least three filter struts.

8. The filter according to claim 3, wherein there are between 4 and 12 filter struts.

9. The filter according to claim 3, wherein there are at least 6 filter struts.

10. The filter according to claim 3, wherein there is between 6 and 18 filter struts.

11. The filter according to claim 1, wherein said at least one attachment strut and said support member are respectively formed from different portions of a helically configured frame having multiple turns, with one turn forming said support member.

14. The filter according to claim 1, wherein said filter media includes a plurality of filter media layers.

15. The filter according to claim 14, wherein there are two filter media layers which are separated from one another.

16. The filter according to claims 1, wherein the filter media includes a pharmacological agent.

17. The filter according to claim 14, wherein at least one of said layers includes a pharmacological agent.

18. The filter according to claim 15, wherein a pharmacological agent is located in a space between the separated filter media layers.

19. The filter according to claim 14, wherein each of said plurality of filter media layers possesses different physical or chemical properties.

23. The filter according to claim 1, wherein said filter media is sombrero shaped.

24. The filter according to claim 1, wherein said filter media is conically shaped.

25. The filter according to claim 1, where said support member and said at least one attachment strut is formed from a biocompatible material.

26. The filter according to claim 25, wherein the biocompatible material is self-expanding.

27. The filter according to claim 25, wherein the biocompatible material is a polymer.

38. The filter according to claim 3, wherein said plurality of attachment struts include at least one integral articulation segment.

39. The filter according to claim 38, wherein said at least one integral articulation segment includes a geometrically altered cross-sectional attachment strut section.

40. The filter according to claim 38, wherein said at least one integral articulation segment includes a zig-zag or undulating configuration.

41. The filter according to claim 2, wherein at least one filter strut includes a radiopaque marker.

43. The filter according to claim 1, wherein said filter media is asymmetrically cone shaped.

50. The method according to claim 4-5, wherein said pattern includes attachment struts and/or support struts.

54. The filter according to claim 3, wherein said at least one attachment strut includes metallurgical articulation segments.

55. The filter according to claim 3, wherein said at least one attachment strut includes different articulation segments.

56. The filter according to claim 1, wherein said at least one attachment strut includes at least one seamless and integral articulation segment.

57. The filter according to claim 56, wherein said at least one seamless and integral articulation segment includes a geometrically altered cross-sectional attachment strut section.

58. The filter according to claim 1, wherein said at least one attachment strut includes at least one seamless and integral metallurgical articulation segment.

70. The filter according to claim 5, wherein said distally extending filter struts terminate at a common seamless distal end.

12. An endovascular device comprising:

a seamless frame having a proximal end, a distal end and a longitudinal axis extending therebetween, said frame having a seamless support member circumscribing said axis and located between said proximal and distal ends, a first set of struts extending seamlessly from said support member towards said proximal end and a second set of struts extending seamlessly from said support member towards said distal end.

13. The device of claim 12, wherein at least one strut of said first and second struts sets includes radiopaque markers.

71. The filter according to claim 12, wherein said distally extending filter struts terminate at a common seamless distal end.

20. An endovascular device comprising:

a seamless frame having a proximal end, a seamless circular support member having a proximally and seamlessly extending attachment strut terminating in a proximal connecting end, and a biocompatible, open ended tubular member having a proximal end attached to said support member.

21. The device according to claim 20, wherein said tubular member has a symmetrically tapered terminal end similar to a windsock.

22. The device according to claim 20, wherein said tubular member is an endovascular graft.

42. The device according to claim 21, wherein said tubular member has an asymmetrically tapered terminal end.

28. A method of constructing a uni-body, self-expanding filter frame comprising:

extracting a substantially two-dimensional filter frame pattern from common planar sheet of precursor material by cutting;

configuring said two-dimensional pattern into a three-dimensional configuration; and

thermally annealing said three-dimensional configuration.

29. The method according to claim 28, wherein said pattern includes attachment struts and support struts.

30. The method according to claim 28, wherein said pattern includes attachment struts, support struts and filter support struts.

31. The method of claim 29, wherein the precursor material is a shape memory alloy.

32. The method according to claim 28, wherein the two-dimensional filter frame has at least one closed cell, the at least one cell including an area that has a circumference defined by a seamlessly continuous ribbon or strut of the same precursor material.

33. The method according to claim 28, further comprising attaching a filter media to the filter frame before or after annealing.

34. The method according to claim 33, wherein the filter media includes a pharmacological agent.

35. The method of claim 28, wherein a portion of said anneal frame is positioned between two layers or portions thereof of filter media and the layers assembly laminated together.

46. The method according to claim 29, wherein said attachment struts have at least one articulation region.

47. The method according to claim 30, wherein said filter struts are adapted to incorporate a radio-opaque marker without adding thickness.

36. A method of attaching a biocompatible, permeable filter media to a three dimensional filter frame comprising:

providing a three-dimensional filter frame;

deforming the three-dimensional frame into a substantially planar, two dimensional configuration; and

adhering at least one layer of filter media on the frame.

37. A method of assembly a filter comprising

providing a conical filter element;

providing a three-dimensional seamless filter frame; and

laminating said filter element and frame together.

44. A method of constructing a uni-body, frame comprising:

extracting a substantially two-dimensional plastically deformable frame pattern from a common planar sheet of plastically deformable material by cutting;

configuring said two-dimensional pattern into a three-dimensional configuration; and

thermally treating said three-dimensional configuration.

48. The method according to claim 44, wherein said pattern includes attachment struts and/or support struts.

49. The method according to claim 44, wherein said pattern includes attachment struts, and/or support struts and/or filter support struts.

52. The method according to claim 49, wherein any of said struts are adapted to incorporate a radio-opaque marker without adding thickness.

45. A method of constructing a uni-body, self-expanding frame comprising:

extracting a substantially two-dimensional frame pattern from a common planar sheet of a shape-memory alloy, self-expanding material by cutting;

configuring said two-dimensional pattern into a three-dimensional configuration; and

thermally annealing said three-dimensional configuration.

51. The method according to claim 45, wherein said pattern includes attachment struts and/or support struts and/or filter support struts.

53. The method according to claim 51, wherein any of said struts are adapted to incorporate a radio-opaque marker without adding thickness.

59. A filter comprising:

a seamless frame having a proximal end and a longitudinal axis, said frame having a seamless support member circumscribing said axis and distally spaced from said proximal end, said support member having at least one attachment strut seamlessly extending therefrom and terminating at said proximal end, and at least one filter media having an open, proximal end cooperating with said support member and a closed end.

60. A device comprising:

a seamless frame having a proximal end, a distal end and a longitudinal axis extending therebetween, said frame having at least one seamless support member circumscribing said axis and located between said proximal and distal ends, at least one of a first set of struts extending seamlessly from said support member towards said proximal end and at least one of a second set of struts extending seamlessly from said support member towards said distal end.

61. The device according to claim 60, wherein a plurality of seamless support members circumscribe said axis.

62. The device according to claim 60, wherein at least one of said struts of said first and second sets of struts and said at least one support member includes at least one of an integral articulation member and a radio-opaque marker.

63. The device according to claim 60, further including at least one seamless and integral articulation segment.

64. The device according to claim 62, further including a plurality of circumscribing members, and at least one integral articulation segment, one of which seamlessly interconnects said members.

65. An endovascular device comprising:

a seamless frame having open proximal and distal ends and a plurality of seamless integral struts formed from a common precursor material, at least some of said struts being seamlessly interconnected with one another to define a plurality of closed cells, and at least one of said plurality of seamless struts optionally having at least one articulation segment and/or radiopaque marker.

66. The device according to claim 65, wherein same frame is a tubular stent.

67. The device according to claim 65, wherein said frame includes integral articulation segments.

68. The device according to claim 65, wherein said frame includes radiopaque markers.

69. The device according to claim 65, wherein said frame includes integral articulation segments and radiopaque markers.