Bifurcated endovascular stents and method and apparatus for their placement

• US 6,056,775 A
• Filed: 01/26/1998
• Issued: 05/02/2000
• Est. Priority Date: 05/31/1996
• Status: Expired due to Term

• Current Assignee: AVE Galway Limited (Medtronic Plc)
• Original Assignee: AVE Galway Limited (Medtronic Plc)
• Inventors: Rickards, Anthony, Borghi, Enzo
• Primary Examiner(s): SNOW, BRUCE EDWARD
• Application Number:
  US09/000,293
• Time in Patent Office: 827 Days
• Field of Search: 623/1, 623/12, 606/192, 606/194, 606/195, 606/108, 600/3, 604/96, 604/114
• US Class Current: 623/1.16
• 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 2/954 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 2002/067 modular
• CPC Class Codes: A61F 2002/825 having longitudinal struts
• CPC Class Codes: A61F 2002/828 Means for connecting a plurality of stents allowing flexibility of the whole structure
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2250/006 modular

Abstract

A bifurcated endovascular stent is formed from a pair of individual tubular component stents that can be placed independently in sequence in the branched region of a body vessel to form the bifurcated stent in situ. The first placed component stent includes a side opening and may be placed to extend both proximally and distally of the bifurcated junction with the side opening facing the entry to the branch vessel. The first component stent then is expanded within the vessel. The second component stent then can be advanced through the first component stent, through the side opening and into the branch vessel where it can be expanded. The portions of the first and second component stents that surround the region of the vessel juncture are constructed to provide enhanced lateral support for the walls of the vessel in the region of the junction. A delivery catheter is provided and includes a guidewire duct adapted to facilitate entry of a guidewire into the branch vessel while the first component stent is being deployed in the other lumen of the vessel.

Claims

1. A method for forming a bifurcated stent within a body lumen having a common portion and first and second branches communicating with the common portion at a juncture, comprising the steps of:

providing a first tubular component stent open at each end, having a side opening between its ends, and being expandable radially from a low profile to an expanded configuration;

providing a catheter having an expansion member at a distal end of the catheter and a guidewire duct having a guidewire port located between ends of the expansion member to enable a distal end of a guidewire to extend out of the guidewire port;

mounting a first component stent on the expansion member with the side opening in registry with the guidewire port;

advancing the assembly of the catheter and first component stent to the juncture of the common portion and first and second branches of the body lumen and with the side opening facing an entrance to the second branch, a proximal portion of the first component stent being disposed within the common portion of the body lumen and a distal portion of the first component stent being disposed in the first branch of the body lumen;

operating the expansion member to expand the first component stent within the body lumen into engagement with an interior surface of the body lumen;

advancing a guidewire through the guidewire duct, the guidewire port and into the second branch of the body lumen;

while maintaining the guidewire in its position in the second branch of the body lumen, removing the catheter from the patient;

advancing a second component stent in to the body lumen, guiding the second component stent by the guidewire to place at least a distal portion of the second component stent through the side opening of the first component stent and in the second branch of the body lumen; and

expanding the second component stent into engagement with an interior surface of the body lumen.

2. A method as defined in claim 1 wherein the expansion member comprises a balloon, the method further comprising folding a portion of the balloon about the distal portion of the guidewire duct before mounting the first component stent on the balloon, the balloon folding being such as to maintain the guidewire port exposed.

3. A method as defined in claim 2 wherein the step of folding the balloon comprises making at least one on each side of the guidewire duct.

4. A method as defined in claim 1 wherein the expansion member comprises an electrical resistance heater and wherein the step of mounting the first component stent on the catheter comprises locating the heater between a shaft of the catheter and the guidewire duct.

5. A method as defined in claim 1 wherein the catheter includes a shaft that includes a guidewire lumen open at the distal tip of the shaft and where the step of advancing the assembly of the catheter and first component stent comprises preliminarily extending the guidewire from the distal end of the catheter and manipulating the guidewire to provide a path for advancing and guiding the catheter to the intended location of stent placement.

6. A method for placing a component stent of a bifurcate stent assembly comprising the steps of:

mounting the component stent on a delivery device having an expansion member at a distal end of the delivery device, the component stent have a side opening between a distal end and a proximal end of the component stent;

interposing a guidewire duct having a guidewire exit port between the expansion member of the delivery device and the stent, with the guidewire duct having a guidewire exit port in registry with the side opening of the component stent;

advancing the assembled delivery device and component stent through a body lumen to a region of a juncture of a common portion and branches of the body lumen with the side opening and the guidewire exit port facing one of the branches.

7. A component stent for placement at a bifurcated region of a body lumen comprising:

an elongate tube-defining member having a proximal section and a distal section, each of the proximal and distal sections including at least one radially expandable module; and

a side opening defined between a distal module of the proximal section and a proximal module of the distal section,

wherein a portion of either the distal module of the proximal section or the proximal module of the distal section extends towards and is in close proximity to either the proximal module of the distal section or the distal module of the proximal section to provide substantially continuous support of the body lumen, and

wherein the modules are formed from wire arranged in a serpentine pattern including a plurality of elongate segments alternated with shorter connective bends, at least some of the elongate segments on at least one of the distal module of the proximal section or the proximal module of the distal section being longer than other elongate segments of said at least one module.

8. A component stent as defined in claim 7 wherein the elongate segments of said at least one module which are disposed laterally of the side opening are longer than the other elongate segments of said at least one module.

9. A component stent as defined in claim 7 wherein the elongate segments are connected to each other at cusps and where the cusps of the distal module of the proximal portion and the proximal module of the distal portion are disposed in close proximity to each other.

10. A component stent as defined in claim 7 wherein the elongate segments are connected to each other at cusps and where the cusps of one of the distal module of the proximal portion or the proximal module of the distal portion overlaps and extends beyond the cusps of the other of the distal module of the proximal portion or the proximal module of the distal portion.

11. A bifurcated stent comprising:

a first component stent and a second component stent, each of which includes a plurality of modules arranged in a sequence to define a generally tubular configuration; and

a side opening defined between a pair of sequentially disposed modules of the first component stent,

wherein the second component stent extends through a portion of the first component stent and projects laterally through the side opening, and

wherein said pair of modules on the first component stent have side portions disposed laterally of the side opening that extend toward and into proximity with each other, and

wherein each module of said pair of modules defining said side opening is formed from wire arranged in a serpentine pattern including elongate segments serially connected to each other by cusps, the elongate segments of said pair of modules being arranged so that some of the cusps of one module of said pair of modules are disposed in close proximity to some of the cusps of the other module of said pair of modules, and

wherein some of the cusps of one module of said pair of modules overlap and extend beyond at least one cusp of the other module of said pair of modules.

12. A catheter for delivering a component stent of a bifurcated stent in which the component stent includes a side opening comprising:

an elongate flexible shaft;

an expansion member mounted to a distal end of the shaft; and

an elongate guidewire duct extending longitudinally of the shaft, the guidewire duct having a distal end exposed externally of the expansion member and defining a guidewire exit port at a location disposed longitudinally between the ends of the expansion member, the guidewire exit port being configured to enable a guidewire to emerge from the guidewire duct in a direction that extends at an angle to the longitudinal axis of the catheter.

13. A delivery catheter as defined in claim 12 wherein the catheter shaft is coaxial and includes an inner tube and an outer tube.

14. A delivery catheter as defined in claim 12 wherein the stent is adapted to expand upon the application of heat and where the expansion member comprises means carried by the catheter for applying heat to the component stent.

15. A delivery catheter as defined in claim 12 wherein the expansion member comprises a balloon.

16. A component stent of a bifurcated stent comprising:

a plurality of loop-like modules connected sequentially to and along a spine to define a generally tubular configuration;

at least two of the modules being formed from wire arranged in a serpentine pattern to include elongate segments connected to each other at cusps; and

a pair of sequentially disposed modules defining a side opening;

wherein at least one of said pair of modules includes elongate segments of different lengths.

17. A component stent as defined in claim 16 wherein said at least one module has a pair of serpentine wires, one of said pair of serpentine wires having elongate segments which are longer than those of the other of said pair of serpentine wires, the serpentine wire with shorter elongate segments being connected to an end of the serpentine wire with longer elongate segments.

18. A component stent as defined in claim 17 wherein the serpentine wire with shorter elongate segments defines the axial ends of the side opening.

19. A component stent as defined in claim 17 wherein the serpentine wire with longer elongate segments defines a portion of the component stent disposed laterally of the side opening.

20. A component stent as defined in claim 18 wherein

one end of the serpentine wire with shorter elongate segments is connected to the spine, and the other end of the serpentine wire with shorter elongate segments is connected to an end of the serpentine wire with longer elongate segments.

21. A component stent as defined in claim 20 wherein the serpentine wire with the shorter elongate segments is connected to the spine at a connector that has a substantially larger radiographic mass than that of the wire.

22. A component stent as defined in claim 21 wherein the serpentine wire with the shorter elongate segments is connected to the serpentine wire with the longer elongate segments at a connector having substantially greater radiographic mass than the wires.

23. A component stent as defined in claim 26 wherein the connectors that connect the serpentine wire with the shorter elongate segments to the spine and the serpentine wire with the longer elongate segments define a generally rectangular pattern that defines the comers of the side opening.

24. A component as defined in claim 26 further comprising:

a short connector wire extended between a junction of said serpentine wire with shorter elongate segments and said serpentine wire with longer elongate segments of one of said pair of modules and a junction of said serpentine wire with shorter elongate segments and said serpentine wire with longer elongate segments of the other of said pair of modules.

25. A component stent as defined in claim 17 where the pitch with respect to a longitudinal axis of the stent of the serpentine wire with shorter elongate segments is less than the pitch with respect to a longitudinal axis of the stent of the serpentine wire with longer elongate segments.

26. A component stent as defined in claim 16, wherein each module of said pair of modules includes a pair of serpentine wires, one of said pair of serpentine wires having elongate segments which are longer than those of the other of said pair of serpentine wires, the serpentine wire with shorter elongate segments being connected at one end to the support wire by a connector and at another end to an end of the serpentine wire with longer elongate segments by a connector.