Noncylindrical drug eluting stent for treating vascular bifurcations

• US 7,344,556 B2
• Filed: 05/09/2003
• Issued: 03/18/2008
• Est. Priority Date: 05/30/2000
• Status: Expired due to Fees

• Current Assignee: Biosensors International Group, Ltd.
• Original Assignee: DEVAX, Inc. (Biosensors International Group, Ltd.)
• Inventors: Seguin, Jacques, Elicker, Robert John, Laborde, Jean-Claude
• Primary Examiner(s): Barrett; Tom
• Application Number:
  US10/435,096
• Publication Number:
  US 20040006381A1
• Time in Patent Office: 1,775 Days
• Field of Search: 623 142- 143, 623/1.35
• US Class Current: 623/1.11
• 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 coronary vessel into a first and a second branch vessels, comprising the steps of:

providing a delivery catheter having a stent thereon, the stent having an upstream end and a downstream end with at least one marker on the downstream end, and being self expandable to a configuration having a single central lumen in which the upstream end has a smaller dimension than the downstream end;

positioning the catheter such that the stent is at a treatment site within the main coronary vessel with the downstream end adjacent the vascular bifurcation;

deploying the stent in the main coronary vessel such that the stent self expands to a configuration in which the upstream end of the stent has a smaller dimension than the downstream end of the stent, and in which the downstream end communicates with both the first and the second branch vessels, wherein said deploying comprises moving a releasable restraint having a plurality of expansion limiting bands with respect to said stent; and

eluting a drug from the stent at the treatment site.

2. 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 eluting a drug step comprises eluting a smooth muscle cell proliferation inhibitor.

3. A method of treating a vascular bifurcation of a main vessel into a first and a second branch vessels as in claim 2, wherein the smooth muscle cell proliferation inhibitor comprises rapamycin.

4. 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 eluting a drug step comprises eluting angiopeptin.

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 eluting a drug step comprises eluting a platelet aggregation inhibitor.

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 eluting a drug step comprises eluting an anti-inflammatory agent.

7. 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 eluting a drug step comprises eluting an antibiotic agent.

8. 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 eluting a drug step comprises eluting paclitaxel.

9. 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 brunch vessels.

10. 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 dimension that is at least about 105% of the dimension of the proximal end of the first stent.

11. 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 at least one marker extends at least partially beyond the downstream end.

12. 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 at least one marker is pressed into the stent.

13. 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 expansion limiting bands comprise stainless steel.

14. 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 expansion limiting bands comprise braided tube.

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

deploying a substantially cylindrical stent in a first branch vessel which is downstream with respect to the bifurcation;

deploying a tapered stent in the main coronary vessel, upstream with respect to the bifurcation, such that the tapered stent has at least one marker and a single central lumen and tapers in the downstream direction from a smaller upstream end to a larger downstream end which faces the bifurcation, wherein said deploying a tapered stent comprises moving a releasable restraint having a plurality of expansion limiting bands with respect to said tapered stent; and

delivering an active agent from at least one of the cylindrical and the tapered stents.

16. A method of treating a vascular bifurcation as in claim 15, wherein the active agent comprises paclitaxel.

17. A method of treating a vascular bifurcation as in claim 15, wherein the active agent comprises rapamycin.

18. A method of treating a vascular bifurcation as in claim 15, wherein the active agent comprises a smooth muscle cell proliferation inhibitor.

19. A method of treating a vascular bifurcation as in claim 15, wherein the active agent comprises a platelet aggregation inhibitor.

20. A method of treating a vascular bifurcation as in claim 15, wherein the active agent comprises an anti-inflammatory agent.

21. A method of treating a vascular bifurcation as in claim 15, wherein the active agent comprises an antibiotic agent.

22. A method of treating a vascular bifurcation as in claim 15, wherein the active agent comprises a calcium entry blocker.

23. A method of treating a vascular bifurcation as in claim 15, wherein the active agent comprises an antimicrobial agent.

24. A method of treating a vascular bifurcation as in claim 15, wherein the at least one marker extends at least partially beyond the downstream end.

25. A method of treating a vascular bifurcation as in claim 15, wherein the at least one marker is pressed into the tapered stent.

26. A method of treating a vascular bifurcation as in claim 15, wherein the expansion limiting bands comprise stainless steel.

27. A method of treating a vascular bifurcation as in claim 15, wherein the expansion limiting bands comprise braided tube.