Noncylindrical stent deployment system for treating vascular bifurcations

• US 8,236,041 B2
• Filed: 10/29/2004
• Issued: 08/07/2012
• Est. Priority Date: 05/30/2000
• Status: Expired due to Fees

• Current Assignee: Biosensors International Group, Ltd.
• Original Assignee: Biosensors International Group, Ltd.
• Inventors: Sequin, Jacques, Elicker, Robert John, Laborde, Jean-Claude
• Primary Examiner(s): DOWE, KATHERINE MARIE
• Application Number:
  US10/976,564
• Publication Number:
  US 20050096726A1
• Time in Patent Office: 2,839 Days
• Field of Search: 623 111- 154, 128/898
• US Class Current: 623/1.12
• 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 2/9517 handle assemblies therefor
• 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 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2/9661 the proximal portion of the stent or stent-graft is released first
• CPC Class Codes: A61F 2002/067 modular
• CPC Class Codes: A61F 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded

Abstract

A device and method for treating pathological narrowing of fluid-carrying conduits of the human body (such as blood vessels) in an area of a bifurcation is disclosed. In particular, a stent system carries a self expandable noncylindrical stent, which is particularly suited for treating a widened portion of a blood vessel immediately proximal to a bifurcation. A stent delivery system is also disclosed, for delivering the stent such that a larger expanded diameter end of the stent faces the bifurcation, and a smaller expanded diameter end of the stent faces proximally in the main vessel.

Claims

1. A deployment system for treating a bifurcation of a main vessel and first and second branch vessels, comprising:

an elongate, flexible body, having a proximal end and a distal end;

a single stent carried by the distal end of the body, the single stent comprising a proximal, upstream end, and a distal, downstream end, and a stent wall extending therebetween;

a releasable restraint, for retaining the stent on the flexible body, the releasable restraint comprising an axially moveable outer sheath having a lubricious layer, wherein a distal end of the lubricious layer is spaced proximally from the outer sheath'"'"'s distal end, thereby providing a section of the releasable restraint at the outer sheath'"'"'s distal end region that is free of the lubricious layer; and

a distal tip comprising an annular recess formed therein configured to receive the releasable restraint'"'"'s distal end, wherein the annular recess at least partially overlaps the lubricious layer;

wherein the distal, downstream end of the stent is larger in diameter than the proximal, upstream end of the stent in an unconstrained expanded configuration, and wherein the stent wall defines a single central lumen and is radially symmetrically disposed about the longitudinal axis of the flexible body when retained on the body.

2. A deployment system as in claim 1, further comprising a guidewire lumen extending axially through at least a portion of the flexible body.

3. A deployment system as in claim 2, wherein the guidewire lumen has a proximal access port and a distal access port, and the proximal access port is positioned along the flexible body, spaced distally apart from the proximal end.

4. A deployment system as in claim 2, wherein the guidewire lumen has a proximal access port and a distal access port, and the proximal access port is positioned at the proximal end of the flexible body.

5. A deployment system as in claim 1, wherein the releasable restraint comprises an axially movable control element extending along a length of the flexible body.

6. A deployment system as in claim 1, wherein the releasable restraint further comprises a pull wire.

7. A deployment system as in claim 1, wherein the releasable restraint further comprises a dissolvable media.

8. A deployment system as in claim 1, wherein the expanded diameter of the single stent tapers radially outwardly in the distal direction.

9. A deployment system as in claim 1, wherein the stent wall is configured to contact and support a wall of the bifurcation from the proximal, upstream end to the distal, downstream end when the stent is deployed in the bifurcation.

10. A deployment system as in claim 1, wherein the stent is uncovered.

11. A deployment system as in claim 1, wherein the lubricious layer is spaced a distance within the range of from about 1 mm to about 3 mm from the outer sheath'"'"'s distal end.

12. A deployment system as in claim 1, wherein the releasable restraint comprises a plurality of expansion limiting bands.

13. A deployment system as in claim 1, wherein the stent comprises a drug capable of being eluted over time.

14. A stent deployment catheter, comprising:

an elongate, flexible tubular body, having a proximal end and a distal end;

a noncylindrical, self-expandable stent carried by the distal end, the stent comprising a proximal end, a distal end, and a stent wall extending therebetween, the stent distal end having a larger diameter than the stent proximal end in an unconstrained expanded configuration, wherein the stent is positioned on the distal end of the tubular body such that the stent distal end is located distally relative to the stent proximal end;

a releasable restraint comprising an axially moveable sheath, covering the noncylindrical, self-expandable stent, wherein a distal portion of the sheath comprises a lubricious layer spaced proximally from a distal end of the sheath;

a distal tip comprising an annular recess formed therein configured to receive the distal end of the sheath, wherein the annular recess at least partially overlaps the lubricious layer; and

a handpiece on the proximal end, wherein the handpiece comprises a control and first and second indicia that indicate partial and complete uncovering of the stent with the sheath when the control is aligned with said first and second indicia, respectively, and wherein the control is configured to be moved from an initial position in which the stent is covered to said first and second indicia.

15. A stent deployment catheter as in claim 14, further comprising a guidewire lumen, in an over the wire configuration.

16. A stent deployment catheter as in claim 14, further comprising a guidewire lumen, in a rapid exchange configuration.

17. A stent deployment catheter as in claim 14, wherein the indicia comprises a marking on the handpiece.

18. A stent deployment catheter as in claim 14, wherein the indicia provides tactile feedback to indicate when said control is aligned with said indicia.

19. A deployment system as in claim 14, wherein the stent comprises a drug capable of being eluted over time.