Endoprosthesis deployment system for treating vascular bifurcations

• US 20030139796A1
• Filed: 11/11/2002
• Published: 07/24/2003
• Est. Priority Date: 06/06/1996
• Status: Active Grant

• Current Assignee: Biosensors International Group, Ltd.
• Original Assignee: Biosensors International Group, Ltd.
• Inventors: Elicker, Robert John, Laborde, Jean-Claude, Sequin, Jacques
• Granted Patent: US 8,728,143 B2
• Time in Patent Office: Days
• 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 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2002/067 modular
• CPC Class Codes: A61F 2002/826 more than one stent being applied sequentially
• 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 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• 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 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2250/0039 differing in diameter

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 delivery system configured to carry one or more of a pair of dissimilar stents. At least one of the stents is particularly suited for treating a widened portion of a blood vessel immediately proximal to a bifurcation. The stent delivery system can also include a handpiece adapted to selectively deliver the stents.

Claims

1. A method of treating a vascular bifurcation of a main vessel into a first and a second branch vessels, comprising the steps of:

providing a delivery catheter having a first stent thereon, the first stent having a proximal end and a distal end, a length of at least about 10 mm, and being self expandable to a configuration in which the proximal end has a smaller diameter than the distal end;

positioning the catheter such that the first stent is at a treatment site within the main vessel with the distal end adjacent the bifurcation; and

deploying the first stent in the main vessel such that the distal end communicates with both the first and the second branch vessels.

2. A method of treating a vascular bifurcation of a main vessel into a first and a second branch vessels as in claim 1, further comprising the step of dilating the treatment site prior to the positioning step.

3. A method of treating a vascular bifurcation of a main vessel into a first and a second branch vessels as in claim 1, wherein the deploying step comprises removing a restraint from the stent and permitting the stent to self expand.

4. A method of treating a vascular bifurcation of a main vessel into a first and a second branch vessels as in claim 1, further comprising the step of deploying a second stent in one of the first and second branch vessels.

5. A method of treating a vascular bifurcation of a main vessel into a first and a second branch vessels as in claim 1, wherein the distal end of the first stent expands to a diameter that is at least about 105% of the diameter of the proximal end of the first stent.

6. A method of treating a vascular bifurcation of a main vessel into a first and a second branch vessels as in claim 1, wherein the distal end of the first stent expands to a diameter that is at least about 110% of the diameter of the proximal end of the first stent.

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

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

a first stent carried in a recess on the distal end of the body; and

a releasable restraint, for retaining the stent on the flexible body;

wherein the distal end of the stent is larger in diameter than the proximal end of the stent in an unconstrained expanded configuration.

8. A deployment system as in claim 7, further comprising a guidewire lumen extending axially through at least a portion of the flexible body.

9. A deployment system as in claim 8, 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.

10. A deployment system as in claim 8, 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.

11. A deployment system as in claim 7, wherein the releasable restraint comprises an axially movable control element extending along the length of the flexible body.

12. A deployment system as in claim 7, wherein the releasable restraint comprises a tubular sheath.

13. A deployment system as in claim 7, wherein the releasable restraint comprises a pull wire.

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

15. A deployment system as in claim 7, further comprising a second stent carried by the distal end of the body.

16. A deployment system as in claim 15, wherein the first and second stents have different expanded geometries from each other.

17. A deployment system as in claim 16, wherein the second stent has a substantially cylindrical unconstrained expanded configuration, having a proximal end, a distal end and a substantially constant radius throughout.

18. A deployment system as in claim 7, wherein the expanded diameter of the first stent tapers radially outwardly in the distal direction.

19. A deployment system as in claim 15, wherein the first and second stents are carried by the catheter such that release of the stents from the catheter causes the distal end of the first stent and the proximal end of the second stent, as implanted, to be separated by a distance of no more than about 4 mm.

20. A deployment system as in claim 19, wherein the distance is no more than about 2 mm.

21. A method of treating a vascular bifurcation of a main vessel into first and second branch vessels, comprising the steps of:

deploying a substantially cylindrical stent in a first branch vessel which is distal to the bifurcation; and

deploying a tapered stent in the main vessel, proximal to the bifurcation;

wherein the tapered stent has a length within the range of from about 10 mm and about 20 mm, and tapers in the distal direction from a smaller proximal diameter to a larger distal diameter which faces the bifurcation.

22. A method of treating a vascular bifurcation as in claim 21, wherein at least one of the substantially cylindrical stent and the tapered stent is deployed from a delivery catheter by proximally retracting an outer sheath on the delivery catheter.

23. A stent deployment catheter, comprising:

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

a recess on the body, having an axial length within the range of from about 5 mm to about 20 mm;

a noncylindrical, self expandable stent carried by the recess;

a handpiece on the proximal end; and

a control on the handpiece, for deploying the stent.

24. A stent deployment catheter as in claim 23, further comprising a guidewire lumen, in an over the wire configuration.

25. A stent deployment catheter as in claim 23, further comprising a guidewire lumen, in a rapid exchange configuration.

26. A method of treating a bifurcation of a main vessel into first and second branch vessels, comprising the steps of:

providing a catheter having a tapered stent thereon;

positioning the catheter in the vicinity of the bifurcation; and

deploying the stent into a vessel such that a larger diameter end of the stent faces the bifurcation and a smaller diameter end of the stent faces the main vessel.

27. A method of treating a bifurcation as in claim 26, wherein the deploying the stent step comprises proximally retracting a tubular sheath.