Bifurcated endovascular stent and methods for forming and placing

• US 6,033,434 A
• Filed: 11/20/1997
• Issued: 03/07/2000
• Est. Priority Date: 06/08/1995
• Status: Expired due to Term

• Current Assignee: AVE Galway Limited (Medtronic Plc)
• Original Assignee: AVE Galway Limited (Medtronic Plc)
• Inventors: Borghi, Enzo
• Primary Examiner(s): Smith, Jeffrey A.
• Application Number:
  US08/945,464
• Time in Patent Office: 838 Days
• Field of Search: 623/1, 623/12, 623/901
• US Class Current: 623/1.35
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• 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 2250/0015 differing in density or specific weight
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2310/00023 Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00059 Chromium or Cr-based alloys
• CPC Class Codes: A61F 2310/00071 Nickel or Ni-based alloys
• CPC Class Codes: A61F 2310/00155 Gold or Au-based alloys
• CPC Class Codes: A61F 2310/00161 Carbon; Graphite

Abstract

A bifurcated endovascular stent is formed by a pair of tube-defining members, one of which is open at its ends and has a lateral opening between its ends. The other tubular structure is adapted to be advanced into one end of the first tube and exit through the lateral opening. The tube-defining members are formed in modular construction, each including an elongate spine and a plurality of generally tube defining modules attached to the spine in a longitudinally sequenced array. The modular construction enables a wide range of variations in the characteristics of the stent, including longitudinal flexibility, radial expansion among others.

Claims

1. A method for forming a bifurcated stent for placement in a body lumen having a common portion and two branches communicating with the common portion comprising:

providing a first tube-defining member open at each end and having a transverse opening formed between its ends, the tube-defining member being expandable radially from a low profile to an expanded configuration;

providing a second tube-defining member having openings at least at its ends, the second tube-defining member being expandable from a low profile configuration to an expanded configuration;

advancing the second tube into the first tube and through the transverse opening thereby to define a bifurcated configuration; and

expanding the second tube from its low profile to an expanded configuration.

2. A method as defined in claim 1 wherein the first tube-defining member is initially in a low profile configuration and is expanded to its expanded configuration before insertion of the second tube-defining member.

3. A method as defined in claim 2 wherein the second tube-defining member is inserted in a low profile and is expanded after forming the bifurcated configuration.

4. A method as defined in any one of the preceding claims wherein the tube-defining members are inelastically expanded.

5. A method as defined in claim 3 wherein each of the tube-defining members has a proximal portion and a distal portion, the proximal portions of the tube-defining members extending longitudinally along a common portion of the stent;

the distal portions of the tube-defining members being separate and adapted to extend independently into branch portions of the body vessel.

6. A method as defined in claim 5 wherein the proximal portion of the first and second tube-defining members are constructed to be complementary to each other and being combinable to cooperatively define a single tubular portion of the bifurcated stent.

7. A method as defined in claim 6 wherein each of the tube defining members comprises an elongate spine having a plurality of tube-defining modules connected thereto in sequential array along the length of the spine, the modules on the proximal portion of each of the tube-defining members being spaced along their respective spines to enable their combination in complementary fashion.

8. A method as defined in claim 7 wherein the transverse opening between the proximal and distal segments of the first tube comprises a space between the proximal and distal portions of the first tube-defining member.

9. A method as defined in claim 7 wherein the spines have substantially greater mass than the modules to enhance their radiographic visibility.

10. A method as defined in claim 1 wherein said assembly of the bifurcated stent is effected in situ within the patient.

11. A method for placing a bifurcated stent in a body lumen having a common portion and two branches communicating with the common portion comprising:

providing a first tube-defining member open at each end and having a transverse opening formed between its ends, the tube-defining member being expandable radially from a low profile to an expanded configuration;

advancing the first member through the body lumen to the branched region with the transverse opening at and exposed to the juncture of the branches of the body lumen;

expanding the first tube-defining member into firm engagement with the inner surface of the common portion and one branch of the body lumen;

providing a second tube-defining member having openings at least at its ends, the second tube-defining member being expandable from a low profile configuration to an expanded configuration;

expanding the first member from its low profile diameter sufficiently to enable it to receive the second member while the second member is in its low profile configuration;

advancing the second member into the first member and through the lateral opening with a portion of the second member extending into the other branch and a portion disposed within the common portion of the body lumen and the first tube-defining member; and

expanding the second tube defining member from its low profile to an expanded configuration and into engagement with the lumen of the common portion and the other branch.

12. A method as defined in claim 11 wherein the tube defining members comprise:

an elongate spine;

a plurality of modules connected to the spine at sequential locations along the spine, each module defining a closed circumferential loop, the modules being arranged on the spine to define the tubular member;

the modules being constructed to be expandable from a low profile configuration to an expanded configuration.

13. A method as defined in claim 12 wherein each module is formed from a serpentine wire having a plurality of elongate segments alternated with shorter connective bends, the module being expandable by a balloon disposed within the tubular member such that when the balloon is expanded to cause expansion of the modules, the elongate segments of the modules will spread apart and wipe against the inner luminal surface of the lumen thereby to smooth the surface of the lumen.

14. A method as defined in claim 12 wherein the spine defines a mass substantially greater than that of the modules sufficiently to present a radiographically visual image of the spine when the device is disposed in the body;

and

positioning the stent within the body lumen by reference to radiographic image of the spine.

15. A bifurcated stent comprising:

a first stent comprising an elongate spine having proximal and distal ends and a plurality of tube-defining modules connected in longitudinal sequence to and along the spine, the modules being arranged to define a proximal group and a distal group, the modules in the proximal group being spaced longitudinally along the spine;

the proximal and distal groups of the tube defining modules on the first stent being spaced from each other to define a lateral opening along the defined tube; and

a second stent having proximal and distal ends, the proximal end having a plurality of spaced modules interfitted with the spaced modules in the first group of the first stent, the distal end of the second stent protruding laterally through the opening.

16. A bifurcated stent comprising as defined in claim 15 wherein each module is formed from a serpentine wire having a plurality of elongate segments alternated with shorter connective bends.

17. A bifurcated stent as defined in claim 16 wherein the serpentine wire has free terminal ends and is attached to the spine by a connector.

18. A bifurcated stent as defined in claim 17 wherein the spine comprises a longitudinal support wire and said connectors.

19. A bifurcated stent as defined in claim 18 wherein at least one of the modules or support wire has a malleability different from the other.

20. A bifurcated stent as defined in claim 18 wherein each of the modules, support wire and connectors are formed from a material sufficiently similar in composition to inhibit development of corrosion at their respective junctures.

21. A bifurcated stent as defined in claim 18 further comprising a spacer disposed between adjacent connectors, the spacers being formed from the same material as the connectors, the spacers and connectors defining substantially continuous regions of high radiopacity when visualized radiographically.

22. A bifurcated stent as defined in claim 18 wherein at least the elongate support wire is formed from a non-metallic material.

23. A bifurcated stent as defined in claim 22 wherein the non-metallic material comprises a polymeric material.

24. A bifurcated stent as defined in claim 23 wherein the material comprises nylon.

25. A bifurcated stent as defined in claim 23 wherein the material for the elongate support wire comprises a bioabsorbable material.

26. A bifurcated stent as defined in claim 17 wherein the end modules of the stent are attached to the support wire with the free terminal ends of one end module oriented toward the free terminal ends of the other end module.

27. A bifurcated stent as defined in claim 15 further comprising a second spine connected to at least some of the modules on at least one of the members and extending generally parallel to the first spine.

28. A bifurcated stent as defined in claim 15 wherein the modules are formed from a material belonging to the group comprising annealed stainless steel, titanium alloys, nickel gold alloys, nickel chromium alloys and titanium chromium alloys.

29. A bifurcated stent as defined in claim 15 wherein the stent is coated with a protective material.

30. A bifurcated stent as defined in claim 15 wherein the protective material comprises carbon.

31. A bifurcated stent as defined in claim 15 wherein the bifurcated stent in coated with a drug.

32. A bifurcated stent as defined in claim 31 wherein the drug comprises an anticoagulant.

33. A bifurcated stent as defined in claim 15 wherein the modules are inelastically deformable during expansion.

34. A bifurcated stent as defined in claim 15 dimensioned to be receivable in a human coronary artery while in a low profile configuration and to be expandable within the artery into engagement with the walls of the coronary artery.

35. A bifurcated stent comprising:

a first elongate support wire;

a second support wire connected at one end to the first support wire at a junction between the ends of the first support wire, thereby defining a proximal portion on one side of the juncture and a pair of branched portions on the other side of the juncture;

a plurality of tube-defining modules connected to the support wire proximally of the juncture and to each of the branch portions of the support wires;

the tube-defining modules on the branch portions of the support wire being disposed at spaced intervals along the branch portions of the support wires to enable the modules on the branch wires to be interfitted and to lie along a substantially common axis with the axis defined by the modules on the proximal portion of the first support wire whereby the bifurcated stent may be compacted into a substantially single tubular configuration insertable into a delivery sheath.

36. A bifurcated stent as defined in 35 further comprising:

the portion of the second support wire that extends between the juncture and the modules on the second support wire being formed to enable relative longitudinal movement between the modules on the second support wire and the juncture.

37. A bifurcated stent as defined in claim 36 wherein said portion of the second support wire is formed into a helical configuration.

38. A method for placing a bifurcated stent in a bifurcated region of a body lumen comprising:

providing a stent constructed as defined in either one of claims 36 or 37 further in which a proximal group of modules is connected to the first support wire proximally of the junction, a distal group of modules connected to one of the branch support wires and an intermediate group of modules connected to the other of the branch support wires, the distal and intermediate groups of modules being spaced on their respective support wires to enable the distal and intermediate module groups to be brought together in alignment along a common axis with that of the proximal group of modules;

compacting the branch portions of the stent to cause the stent to assume a generally singular tubular configuration;

loading the compacted stent into the distal end of a sheath of a delivery catheter;

advancing the delivery catheter to the site where the stent is to be implanted;

positioning the sheath so that the distal group of modules on the second support wire are disposed in one branch of the body lumen, the next proximal group of modules is disposed in the region of the juncture of the branches of the body lumen and the more proximal group of modules is disposed in the common portion of the body lumen;

withdrawing the sheath while maintaining the position of the stent sufficiently to expose the distal group of modules in one of the branches of the body lumen;

expanding the distal group of modules into firm engagement with the branch of the body lumen;

withdrawing further the sheath to expose the intermediate group of modules;

directing the intermediate group of modules into the other branch of the body lumen;

expanding the intermediate group of modules into firm engagement with the other branch of the body lumen;

then withdrawing the sheath further to expose the proximal group of modules within the portion of the body lumen proximal of the branch; and

expanding the proximal group of modules into firm engagement with the proximal portion of the body lumen.

39. A method as defined in claim 38 further comprising:

before expanding the proximal group of modules, adjusting the longitudinal position of the proximal group of modules relative to the distal group of modules by adjusting the longitudinal extent of the variable segment of the second support wire.