Bifurcated stent with improved side branch aperture and method of making same

• US 20020035389A1
• Filed: 06/26/2001
• Published: 03/21/2002
• Est. Priority Date: 05/03/1996
• Status: Active Grant

• Current Assignee: Medinol Limited (Medinol USA Incorporated)
• Original Assignee: Medinol Limited (Medinol USA Incorporated)
• Inventors: Richter, Jacob, Pinchasik, Gregory
• Granted Patent: US 6,540,779 B2
• Time in Patent Office: Days
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2/856 Single tubular stent with a side portal passage
• 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 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2220/0041 using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes

Abstract

A bifurcated stent for insertion into a bifurcated vessel such as a blood vessel. In one embodiment, a first sheet is formed into a first leg, a second sheet is formed into a second leg, a third sheet is formed into a stem, and the two legs are attached to the stem. In a second embodiment, a first sheet is formed into a member having a first leg and half of a stem, a second sheet is formed into a second member having a second leg and half of a stem, and the two stem halves are combined to form the bifurcated stent. In a third embodiment, the stent comprises two sections that are serially inserted and assembled within the vessel at the site of the bifurcation to be treated.

Claims

1. A method of making a bifurcated stent comprising the steps of:

a) preparing a sheet having a proximal end, a distal end, a longitudinal axis, and a circumferential axis, the sheet provided with;

a first side having a proximal portion having a proximal end and a distal end and a distal portion having a proximal end and a distal end;

a second side having a proximal end and a distal end, the second side disposed between the proximal end of the sheet and the distal end of the sheet;

a third side having a proximal end and a distal end, the third side disposed between the distal end of the second side and the distal end of the sheet;

a fourth side disposed between the proximal end of the proximal portion of the first side and the proximal end of the second side;

a fifth side disposed between the distal end of the distal portion of the first side and the distal end of the third side, the fifth side having a length that is shorter than the length of the fourth side; and

a sixth side disposed between the second side and the third side;

b) attaching the second side to the proximal portion of the first side and attaching the third side to the distal portion of the first side to form a first expandable tubular member having a longitudinal bore defining a longitudinal axis, the fourth side defining a proximal stent aperture communicating with the longitudinal bore, the fifth side defining a distal stent aperture communicating with the longitudinal bore, and the sixth side and the proximal end of the third side and the proximal end of the distal portion of the first side defining a side branch aperture communicating with the longitudinal bore and sized and adapted to receive and secure a second expandable tubular member;

c) delivering the first expandable tubular member to a bifurcated vessel having a first lumen and a second lumen so that the first expandable tubular member is disposed within the first lumen and the branch aperture communicates with the second lumen;

d) expanding the first expandable tubular member in an amount sufficient to secure the first expandable tubular member in the first lumen;

e) preparing a second expandable tubular member having a proximal end and a distal end and having longitudinal bore therethrough;

f) delivering the second expandable tubular member into the branch aperture of the first tubular member so that the distal end of the second expandable tubular member is disposed within the second lumen and the proximal end of the second expandable tubular member is disposed within the longitudinal bore of the first tubular member; and

g) expanding the second expandable tubular member in an amount sufficient to secure the second expandable tubular member within the second lumen and within the branch aperture.

2. The method of claim 1, wherein the attaching step is carried out utilizing screwing.

3. The method of claim 1, wherein the attaching step is carried out utilizing crimping.

4. The method of claim 1, wherein the attaching step is carried out utilizing soldering.

5. The method of claim 1, wherein the attaching step is carried out utilizing welding.

6. The method of claim 1, wherein the welding step is carried out utilizing spot welding.

7. The method of claim 1, wherein the fifth side has a length that is about 70% of the length of the fourth side.

8. The method of claim 1, further comprising the steps of providing the first and second tubular members with a plurality of cells adapted to be substantially flexible prior to expansion and substantially rigid after expansion.

9. The method of claim 1, further comprising the step of providing the sheet and the second tubular member with an etched pattern defining a plurality of cells.

10. The method of claim 9, wherein the cells are adapted to be substantially flexible prior to the expansion of the first and second tubular members and are adapted to be substantially rigid after the expansion of the first and second tubular members.

11. The method of claim 10, wherein the cells of the sheet are substantially uniform.

12. The method of claim 10, wherein the cells of the second tubular member are substantially uniform.

13. The method of claim 10, wherein the cells of the sheet and the cells of the second tubular member are substantially uniform.

14. The method of claim 11, wherein the number of cells disposed along the circumferential axis of the fifth side of the sheet and the number of cells disposed along the circumferential axis of the fourth side of the sheet are in a ratio of about 5:

7.

15. The method of claim 1, wherein the branch aperture is larger than the proximal and distal apertures of the first tubular member.

16. The method of claim 1, wherein the first, second, and third sides are substantially parallel to each other and the fourth, fifth, and sixth sides are substantially parallel to each other.

17. The method of claim 16, wherein the first, second, and third sides are substantially perpendicular to the fourth, fifth, and sixth sides.

19. The stent of claim 18, wherein the attaching means is a screw.

20. The stent of claim 18, wherein the attaching means is a crimp.

21. The stent of claim 18, wherein the attaching means is solder.

22. The stent of claim 18, wherein the attaching means is a weld.

23. The stent of claim 18, wherein the attaching means is a spot weld.

24. The stent of claim 18, wherein the fifth side has a length that is about 70% of the length of the fourth side.

25. The stent of claim 18, wherein the first and second tubular members are provided with a plurality of cells adapted to be substantially flexible prior to expansion and substantially rigid after expansion.

26. The stent of claim 18, wherein the sheet and the second tubular member comprise an etched pattern defining a plurality of cells.

27. The stent of claim 26, wherein the cells are adapted to be substantially flexible prior to the expansion of the first and second tubular members and are adapted to be substantially rigid after the expansion of the first and second tubular members.

28. The stent of claim 27, wherein the cells of the sheet are substantially uniform.

29. The stent of claim 27, wherein the cells of the second tubular member are substantially uniform.

30. The stent of claim 27, wherein the cells of the sheet and the cells of the second tubular member are substantially uniform.

31. The stent of claim 28, wherein the number of cells disposed along the circumferential axis of the fifth side of the sheet and the number of cells disposed along the circumferential axis of the fourth side of the sheet are in a ratio of about 5:

7.

32. The stent of claim 18, wherein the branch aperture larger than the proximal and distal apertures of the first tubular member.

33. The stent of claim 18, wherein the first, second, and third sides are substantially parallel to each other and the fourth, fifth, and sixth sides are substantially parallel to each other.

34. The stent of claim 33, wherein the first, second, and third sides are substantially perpendicular to the fourth, fifth, and sixth sides.

37. The method of claim 36, wherein the attaching step is carried out utilizing screwing.

38. The method of claim 36, wherein the attaching step is carried out utilizing crimping.

39. The method of claim 36, wherein the attaching step is carried out utilizing soldering.

40. The method of claim 36, wherein the attaching step is carried out utilizing welding.

41. The method of claim 40, wherein the welding step is carried out utilizing spot welding.

42. The method of claim 36, further comprising the step of providing the first and second tubular members with a plurality of cells adapted to be substantially flexible prior to expansion and substantially rigid after expansion.

43. The method of claim 36, further comprising the step of providing the first tubular member proximal member, the first tubular member distal member and the second tubular member with an etched pattern defining a plurality of cells.

44. The method of claim 43, wherein the cells are adapted to be substantially flexible prior to the expansion of the first and second tubular members and are adapted to be substantially rigid after the expansion of the first and second tubular members.

45. The method of claim 44, wherein the cells of the first tubular member and the cells of the second tubular member are substantially uniform.

47. The stent of claim 46, wherein the attaching means is a screw.

48. The stent of claim 46, wherein the attaching means is a crimp.

49. The stent of claim 46, wherein the attaching means is solder.

50. The stent of claim 46, wherein the attaching means is a weld.

51. The stent of claim 50, wherein the weld is a spot weld.

52. The stent of claim 46, wherein the first and second tubular members are comprised of a plurality of cells adapted to be substantially flexible prior to expansion and substantially rigid after expansion.

53. The stent of claim 46, wherein the first tubular member proximal member, the first tubular member distal member, and the second tubular member comprise an etched pattern defining a plurality of cells.

54. The stent of claim 53, wherein the plurality of cells are adapted to be substantially flexible prior to the expansion of the first and second tubular members and are adapted to be substantially rigid after the expansion of the first and second tubular members.

55. The stent of claim 54, wherein the cells of first tubular member and the cells of the second tubular member are substantially uniform.

18. A bifurcated stent comprising:

a) a first tubular member having a proximal end and a distal end and a longitudinal bore therethrough defining a longitudinal axis, the first tubular member comprised of a sheet having a proximal end, a distal end, a longitudinal axis, and a circumferential axis, the sheet provided with;

a first side having a proximal portion having a proximal end and a distal end and a distal portion having a proximal end and a distal end;

a second side having a proximal end and a distal end, the second side disposed between the proximal end of the sheet and the distal end of the sheet;

a third side having a proximal end and a distal end, the third side disposed between the distal end of the second side and the distal end of the sheet;

a fourth side disposed between the proximal end of the proximal portion of the first side and the proximal end of the second side;

a fifth side disposed between the distal end of the distal portion of the first side and the distal end of the third side, the fifth side having a length that is shorter than the length of the fourth side; and

a sixth side disposed between the second side and the third side;

b) means for attaching the second side to the proximal portion of the first side and the third side to the distal portion of the first side so that the fourth side defines a proximal stent aperture communicating with the longitudinal bore, the fifth side defines a distal stent aperture communicating with the longitudinal bore, and the sixth side and the proximal end of the third side and the proximal end of the distal portion of the first side define a side branch aperture communicating with the longitudinal bore and sized and adapted to receive and secure a second tubular member; and

c) a second tubular member having a proximal end and a distal end and having longitudinal bore therethrough, the second tubular member disposed within the branch aperture so that the proximal end of the second tubular member is disposed within the longitudinal bore of the first tubular member.

35. A kit for forming a bifurcated stent comprising:

a) a first expandable tubular member having a proximal end and a distal end and a longitudinal bore therethrough defining a longitudinal axis, the first expandable tubular member comprised of a sheet having a proximal end, a distal end, a longitudinal axis, and a circumferential axis, the sheet provided with;

a first side having a proximal portion having a proximal end and a distal end and a distal portion having a proximal end and a distal end;

a second side having a proximal end and a distal end, the second side disposed between the proximal end of the sheet and the distal end of the sheet;

a third side having a proximal end and a distal end, the third side disposed between the distal end of the second side and the distal end of the sheet;

a fourth side disposed between the proximal end of the proximal portion of the first side and the proximal end of the second side;

a fifth side disposed between the distal end of the distal portion of the first side and the distal end of the third side, the fifth side having a length that is shorter than the length of the fourth side; and

a sixth side disposed between the second side and the third side;

b) means for attaching the second side to the proximal portion of the first side and for attaching the third side to the distal portion of the first side so that the fourth side defines a proximal stent aperture communicating with the longitudinal bore, the fifth side defines a distal stent aperture communicating with the longitudinal bore, and the sixth side and the proximal end of the third side and the proximal end of the distal portion of the first side define a side branch aperture communicating with the longitudinal bore and sized and adapted to receive and secure a second expandable tubular member;

c) a second expandable tubular member having a proximal end and a distal end and having longitudinal bore therethrough, the second expandable tubular member sized and adapted to be disposed and secured within the branch aperture so that the proximal end of the second tubular member is disposed within the longitudinal bore of the first tubular member;

c) a first guide wire;

d) a second guide wire;

e) a first balloon catheter; and

f) a second balloon catheter.

36. A method of making a bifurcated stent comprising the steps of:

a) cutting a proximal member from a first expandable tube having a first cross-sectional diameter, the proximal member having a proximal end and a distal end and a longitudinal bore therethrough;

b) cutting a distal member from a second expandable tube having a second cross-sectional diameter smaller than the first diameter of the first tube, the distal member having a proximal end and a distal end and a longitudinal bore therethrough;

c) attaching a portion of the distal end of the proximal member to a portion of the proximal end of the distal member so that the longitudinal bore of the proximal member is in fluid communication with the longitudinal bore of the distal member to form a first expandable tubular member having a proximal end and a distal end and a longitudinal bore therethrough, the unattached portion of the distal end of the proximal member and the unattached portion of the proximal end of the distal member defining a side branch aperture communicating with the longitudinal bore of the first tubular member and sized and adapted to receive and secure a second expandable tubular member;

c) delivering the first expandable tubular member to a bifurcated vessel having a first lumen and a second lumen so that the first expandable tubular member is disposed-within the first lumen and the branch aperture communicates with the second lumen;

d) expanding the first expandable tubular member in an amount sufficient to secure the first expandable tubular member in the first lumen;

e) preparing a second expandable tubular member having a proximal end and a distal end and having longitudinal bore therethrough;

f) delivering the second expandable tubular member into the branch aperture of the first tubular member so that the distal end of the second expandable tubular member is disposed within the second lumen and the proximal end of the second expandable tubular member is disposed within the longitudinal bore of the first tubular member; and

g) expanding the second expandable tubular member in an amount sufficient to secure the second tubular member within the second lumen and within the branch aperture.

46. A bifurcated stent comprising:

a) a first tubular member having a proximal end and a distal end and a longitudinal bore herethrough, the first tubular member comprised of a proximal member and a distal member, the proximal member having a first cross-sectional diameter, a proximal end and a distal end and a longitudinal bore therethrough, and the distal member having a second cross-sectional diameter smaller than the first diameter, a proximal end and a distal end and a longitudinal bore therethrough;

b) means for attaching a portion of the distal end of the proximal member to a portion of the proximal end of the distal member so that the longitudinal bore of the proximal member is in fluid communication with the longitudinal bore of the distal member to form the first tubular member, the unattached portion of the distal end of the proximal member and the unattached portion of the proximal end of the distal member defining a side branch aperture communicating with the longitudinal bore of the first tubular member and sized and adapted to receive and secure a second expandable tubular member; and

c) a second tubular member having a proximal end and a distal end and having longitudinal bore therethrough, the second tubular member disposed and secured within the branch aperture so that the proximal end of the second tubular member is disposed within the longitudinal bore of the first tubular member.

56. A kit for forming a bifurcated stent comprising:

a) a first expandable tubular member having a proximal end and a distal end and a longitudinal bore therethrough, the first expandable tubular member comprised of an expandable proximal member and an expandable distal member, the expandable proximal member having a first cross-sectional diameter, a proximal end and a distal end and a longitudinal bore therethrough and the expandable distal member having a second cross-sectional diameter smaller than the first diameter, a proximal end and a distal end and a longitudinal bore therethrough;

b) means for attaching a portion of the distal end of the expandable proximal member to a portion of the proximal end of the expandable distal member so that the longitudinal bore of the expandable proximal member is in fluid communication with the longitudinal bore of the expandable distal member to form the first expandable tubular member, the unattached portion of the distal end of the expandable proximal member and the unattached portion of the proximal end of the expandable distal member defining a side branch aperture communicating with the longitudinal bore of the first expandable tubular member and sized and adapted to receive and secure a second expandable tubular member;

c) a second expandable tubular member having a proximal end and a distal end and having longitudinal bore therethrough, the second expandable tubular member sized and adapted to be disposed and secured within the branch aperture so that the proximal end of the second expandable tubular member is disposed within the longitudinal bore of the first tubular member;

c) a first guide wire;

d) a second guide wire;

e) a first balloon catheter; and

f) a second balloon catheter.