Bifurcated stent and method for the manufacture and delivery of same

• US 5,906,640 A
• Filed: 05/02/1997
• Issued: 05/25/1999
• Est. Priority Date: 11/03/1994
• Status: Expired due to Term

• Current Assignee: Divysio Solutions ULC
• Original Assignee: Divysio Solutions ULC
• Inventors: Ricci, Donald R., Penn, Ian M., Shukov, George A.
• Primary Examiner(s): Milano, Michael J.
• Application Number:
  US08/850,742
• Time in Patent Office: 753 Days
• Field of Search: 623/1, 623/12
• US Class Current: 623/1.15
• CPC Class Codes: A61F 2/852 Two or more distinct overlapping stents
• 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 2002/067 modular
• CPC Class Codes: A61F 2002/828 Means for connecting a plurality of stents allowing flexibility of the whole structure
• CPC Class Codes: A61F 2002/91525 within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/91566 connected trough to trough
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2210/0042 using a fluid, e.g. circulating
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/006 modular

Abstract

An expandable bifurcated stent comprising a proximal end and a distal end in communication with one another. The proximal end comprises a primary passageway and the distal end comprises a pair of secondary passageways. The stent is expandable from a first, contracted position to a second, expanded position upon the application of a radially outward force exerted on the stent. Each of the primary passageway and the secondary passageway being constructed of has a porous surface. A method for production of a bifurcated stent is also described. Preferably, the method comprises the step of connecting a first stent section to a second stent section, the first stent section having an end thereof adapted for connection to an opening disposed along the length of a second stent section.

Claims

1. An ex vivo expandable bifurcated stent comprising a proximal end and a distal end in communication with one another, the proximal end comprising a primary passageway and the distal end comprising a pair of secondary passageways, each secondary passageway coupled to the primary passageway at a first intersection, the stent being expandable from a first, contracted position to a second, expanded position upon the application of a radially outward force exerted on the stent, each of the primary passageway and the second passageways being constructed of a tubular wall having a porous surface, at least one reinforcing member being disposed at the first intersection for reinforcing the first intersection, said reinforcing member overlapping at least one of (i) said primary passageway, (ii) a first of said secondary passageways, and (iii) a second of said secondary passageways, said reinforcing member being separate structure from same first intersection.

2. The bifurcated stent defined in claim 1, wherein the stent comprises a first stent section connected to a second stent section.

3. The bifurcated stent defined in claim 2, wherein an end of the first stent section is connected to an opening disposed along a length of the second stent section.

4. The bifurcated stent defined in claim 3, wherein a first connection portion is disposed at an end of the first stent section and is connected to the second stent section.

5. The bifurcated stent defined in claim 4, wherein the first connection portion is integral with an end of the first stent section.

6. The bifurcated stent defined in claim 4, wherein the first connection portion comprises a porous section and a non-porous section, the non-porous section connected to the second stent section.

7. The bifurcated stent defined in claim 6, wherein the porous section comprises a plurality of elongate slots.

8. The bifurcated stent defined in claim 7, wherein the elongate slots traverse the thickness of at least one connection tab.

9. The bifurcated stent defined in claim 7, wherein the elongate slots are disposed substantially orthogonal to a longitudinal axis of the first stent section.

10. The bifurcated stent defined in claim 2, wherein the second stent section comprises a second connection portion along at least a portion of the periphery of the opening, the second connection portion connected to the first stent section.

11. The bifurcated stent defined in claim 2, wherein the first stent section and the second stent section are coaxially disposed with respect to one another along at least a portion of the primary passageway.

12. The bifurcated stent defined in claim 2, wherein the first stent section and the second stent section are coaxially disposed with respect to one another along substantially the entire length of the primary passageway.

13. The bifurcated stent defined in claim 2, wherein the first stent section and the second stent section are connected to one another and to a third stent section, at least one of the stent sections comprising the primary passageway and each of the other to stent sections comprising a secondary passageway.

14. The bifurcated stent defined in claim 1, wherein the at least one connection portion interconnects the pair of secondary passageways.

15. The bifurcated stent defined in claim 1, wherein the at least one connection portion connects one of the pair of second passageways to the primary passageway.

16. A stent according to claim 1, wherein the reinforcing member is integral with the first of said secondary passageways and is coupled to the second of said secondary passageways.

17. A stent according to claim 1, wherein the reinforcing member is integral with the first of said secondary passageways and overlaps said primary passageway.

18. A stent according to claim 1, wherein said first secondary passageway and said second secondary passageway form a crotch, and wherein said reinforcing member is disposed in said crotch.

19. A stent according to claim 1, wherein said reinforcing member extends circumferentially less than the entire circumference of the passageway which it overlaps.

20. A stent according to claim 1, wherein an open-faced end of one of said secondary passageways is coupled to a corresponding opening in said primary passageway.

21. A stent according to claim 1, wherein said reinforcing member comprises a T-shaped tab wherein the top portion of said tab extends circumferentially around a portion of the overlapped passageway.

22. A stent according to claim 1, wherein said reinforcing member extends from the second of said secondary passageways and overlaps said primary passageway, and further comprising a further reinforcing member which extends from said second secondary passageway and overlaps said first secondary passageway.

23. A method for production of an ex vivo bifurcated stent comprising the steps of:

connecting a first stent section to a second stent section at an intersection, the first stent section having an end thereof adapted for connection to an opening disposed along the length of a second stent section, each of said first stent section and said second stent section being constructed of a tubular wall having a porous surface; and

disposing a reinforcing member at an intersection between said first stent section and said second stent section, said reinforcing member overlapping at least one of (i) said first stent section, and (ii) said second stent section, said reinforcing member being separate structure from the intersection between said first stent section and said second stent section.

24. The method defined in claim 23, wherein the end of the first stent section adapted for connection is bevelled with respect to a longitudinal axis of the first stent section.

25. The method defined in claim 23, comprising the further step of disposing at least one second flap portion at a periphery of the opening disposed along the length of the second stent section.

26. The method defined in claim 23, comprising the further step of disposing a pair of second flap portions at a periphery of the opening disposed along the length of the second stent section.

27. The method defined in claim 26, wherein, prior to the connecting step, at least one second flap portion is trimmed to a reduced size.

28. The method defined in claim 26, comprising the further step of overlapping the at least one second flap portion of the second stent section on to a portion of the first stent section.

29. The method defined in claim 28, wherein the connecting step comprises welding the at least one second flap portion of the second stent section to the first stent section.

30. The method defined in claim 26, wherein, prior to the connecting step, at least one second flap portion is removed.

31. The method defined in claim 23, comprising the further steps of producing the second stent section by:

providing a pair of third stent sections, each third stent sections having an end thereof bevelled with respect to a longitudinal axis of the third stent section;

joining the pair of third stent sections in a complementary manner at each bevelled end thereof to provide a substantially V-shaped stent section; and

removing an apex portion of the V-shaped stent section to define the second stent section having an opening therein.

32. The method defined in claim 31, wherein the connecting step comprises connecting the end of the first stent section to the opening defined in the V-shaped stent section.

33. The method defined in claim 23, wherein the connecting step comprises welding the first stent section to the second stent section.

34. A method for production of a bifurcated stent comprising the steps of:

connecting a first stent section to a second stent section, the first stent section having an end thereof adapted for connection to an opening disposed along the length of a second stent section; and

disposing at least one first flap portion at the end of the first stent section adapted for connection to a portion of the second stent section.

35. The method defined in claim 34, wherein the at least one flap portion comprises a connection tab having a non-porous surface disposed on at least a portion thereof.

36. The method defined in claim 34, wherein the at least one flap portion comprises a connection tab having a porous surface disposed on at least a portion thereof.

37. The method defined in claim 36, wherein the porous surface comprises a plurality of substantially elongate slots.

38. The method defined in claim 34, wherein the at least one flap portion comprises a connection tab having both a porous surface and non-porous surface disposed thereon.

39. The method defined in claim 38, wherein the porous surface comprises a plurality of substantially elongate slots.

40. The method defined in claim 34, wherein the at least one first flap portion is produced by folding from the end of the first stent section adjacent the bevelled cut.

41. The method defined in claim 34, wherein, prior to the connecting step, the at least one first flap portion is trimmed to a reduced size.

42. The method defined in claim 34, comprising the further step of overlapping the at least one first flap portion of the first stent section on to a portion of the second stent section.

43. The method defined in claim 42, wherein the connecting step comprises welding the at least one first flap portion of the first stent section to the second stent section.

44. The method defined in claim 34, wherein, prior to the connecting step, the at least one first flap portion is removed.

45. A method for production of a bifurcated ex vivo stent comprising the steps of:

passing a first stent section having a first opening disposed along a length thereof through a second stent section having a second opening disposed along a length thereof, the first stent section having a diameter less than a diameter of the second stent section, the first stent section and the second stent section each comprising a tubular wall having a porous surface;

passing a leading end of the first stent section through the second opening of the second stent section;

substantially aligning the first opening and the second opening with respect to one another at an intersection; and

affixing the first stent section to the second stent section with a reinforcing member that overlaps at least one of the first stent section and the second stent section, the reinforcing member being a separate structure from the intersection between the first stent section and the second stent section.

46. An expandable ex vivo bifurcated stent comprising a proximal end and a distal end in communication with one another, the proximal end comprising a primary passageway and the distal end comprising a pair of secondary passageways, each secondary passageway in communication with the primary passageway at a first intersection, the stent being expandable from a first, contracted position to a second, expanded position upon the application of a radially outward force exerted on the stent, each of the primary passageway and the secondary passageways having a porous surface, each of said primary passageway and said secondary passageway comprising a tubular wall, at least one reinforcing portion interconnecting the pair of secondary passageways for reinforcing the first intersection, said reinforcing portion overlapping at least one of the secondary passageways, said reinforcing portion being separate structure from the first intersection between the primary passageway and the secondary passageways.