Multi-stent and multi-balloon apparatus for treating bifurcations and methods of use

• US 9,254,210 B2
• Filed: 03/12/2013
• Issued: 02/09/2016
• Est. Priority Date: 02/08/2011
• Status: Active Grant

• Current Assignee: Advanced Bifurcation Systems, Inc.
• Original Assignee: Advanced Bifurcation Systems, Inc.
• Inventors: Bourang, Henry
• Primary Examiner(s): Stransky, Katrina
• Assistant Examiner(s): SCHWIKER, KATHERINE H
• Application Number:
  US13/796,466
• Publication Number:
  US 20130268047A1
• Time in Patent Office: 1,064 Days
• Field of Search: 623/1.35, 623/1.11, 623/1.16
• US Class Current: 1/1
• CPC Class Codes: A61F 2/844 folded prior to deployment
• CPC Class Codes: A61F 2/852 Two or more distinct overlapping stents
• CPC Class Codes: A61F 2/90 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 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2002/821 Ostial stents
• CPC Class Codes: A61F 2002/826 more than one stent being applied sequentially
• CPC Class Codes: A61F 2002/828 Means for connecting a plurality of stents allowing flexibility of the whole structure
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 2025/1045 for treating bifurcations, e.g. balloons in y-configuration, separate balloons or special features of the catheter for treating bifurcations
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A system for treating a bifurcated vessel that includes a first delivery catheter and a second delivery catheter. The first delivery catheter carries a proximal first stent and a distal second stent. The first delivery catheter also has a first elongate shaft, a proximal first expandable member with the proximal first stent disposed thereover, and a distal second expandable member with the distal second stent disposed thereover. The proximal first expandable member and distal second expandable member are independently expandable of one another. The second delivery catheter carries a third stent. The second delivery catheter also has a second elongate shaft, and a third expandable member with the third stent disposed thereover. The third expandable member is independently expandable of the proximal first expandable member and the distal second expandable member.

Claims

1. A method for treating a bifurcated vessel in a patient, the bifurcated vessel having a main branch and a side branch, said method comprising:

providing a first delivery catheter comprising a proximal first expandable member, a distal second expandable member, a proximal first stent, and a distal second stent,

wherein the proximal first expandable member and distal second expandable member are disposed close to or at a distal end of the first delivery catheter,

wherein the proximal first stent and the distal second stent are discrete stents, the proximal first stent disposed over the proximal first expandable member, and the distal second stent disposed over the distal second expandable member, and

wherein a distal portion of the proximal first stent comprises a notched region, and a proximal portion of the distal second stent comprises a notched region, the notched regions being cut out portions of the distal portion of the proximal first stent and the proximal portion of the distal second stent, respectively, and the notched regions being adjacent one another to form a side hole in the proximal first stent and the distal second stent;

providing a second delivery catheter comprising a third expandable member and a third stent, the third expandable member disposed close to or at a distal end of the second delivery catheter,

wherein the third stent is disposed over the third expandable member, and

wherein the second delivery catheter passes through the side hole in the proximal first stent and the distal second stent;

advancing the first delivery catheter and the second delivery catheter toward the bifurcation;

positioning the proximal first stent, the distal second stent, and the third stent at the bifurcation such that the proximal first stent is disposed in the main branch, the distal second stent is disposed in the side branch, and the third stent is disposed in the main branch downstream of the bifurcation,

wherein the side hole in the proximal first stent and the distal second stent is aligned with the main branch and faces downstream of the bifurcation;

radially expanding the distal second stent from a collapsed configuration to an expanded configuration;

radially expanding the proximal first stent from a collapsed configuration to an expanded configuration; and

radially expanding the third stent from a collapsed configuration to an expanded configuration.

2. The method of claim 1, wherein positioning the proximal first stent, the distal second stent, and the third stent comprises advancing the first delivery catheter and the second delivery catheter until one or more of the delivery catheters engage a carina of the bifurcation.

3. The method of claim 1, wherein radially expanding the distal second stent comprises expanding the distal second stent to engage a wall of the side branch.

4. The method of claim 1, wherein radially expanding the distal second stent comprises expanding the distal second expandable member.

5. The method of claim 4, wherein the distal second expandable member comprises a balloon, and expanding the distal second expandable member comprises inflating the balloon.

6. The method of claim 1, wherein radially expanding the proximal first stent comprises expanding the proximal first stent to engage a wall of the main branch.

7. The method of claim 1, wherein radially expanding the proximal first stent comprise expanding the proximal first expandable member.

8. The method of claim 7, wherein the proximal first expandable member comprises a balloon, and expanding the proximal first expandable member comprises inflating the balloon.

9. The method of claim 1, wherein the proximal first stent is radially expanded before radial expansion of the distal second stent.

10. The method of claim 1, wherein radially expanding the third stent comprises expanding the third stent to engage a wall of the main branch.

11. The method of claim 10, wherein radially expanding the third stent comprises expanding the third expandable member.

12. The method of claim 11, wherein the third expandable member comprises a balloon, and expanding the third expandable member comprises inflating the balloon.

13. The method of claim 1, wherein the third stent is radially expanded after radial expansion of the proximal first stent and the distal second stent.

14. The method of claim 1, further comprising proximally retracting the second delivery catheter so that a proximal end of the third stent is aligned with the side hole in the proximal first stent and the distal second stent.

15. The method of claim 14, wherein proximally retracting the second delivery catheter comprises aligning a radiopaque maker on the second delivery catheter with a radiopaque marker on the first delivery catheter.

16. The method of claim 14, wherein proximally retracting the second delivery catheter comprises sliding the second delivery catheter under a portion of the proximal first stent.

17. The method of claim 16, wherein proximally retracting the second delivery catheter comprises sliding the second delivery catheter through the side hole in the proximal first stent and the distal second stent.

18. The method of claim 1, wherein a proximal portion of the third stent abuts a portion of the proximal first stent and a portion of the distal second stent, after radial expansion of the proximal first stent, the distal second stent, and the third stent.

19. The method of claim 18, wherein the distal portion of the proximal first stent abuts the proximal portion of the distal second stent after radial expansion thereof.