Stent alignment during treatment of a bifurcation

• US 9,855,158 B2
• Filed: 06/24/2014
• Issued: 01/02/2018
• Est. Priority Date: 09/25/2008
• Status: Active Grant

• Current Assignee: Advanced Bifurcation Systems, Inc.
• Original Assignee: Advanced Bifurcation Systems, Inc.
• Inventors: Bourang, Henry, Khorsandi, Mehran
• Primary Examiner(s): Nguyen, Victor
• Assistant Examiner(s): HOLLM, JONATHAN A
• Application Number:
  US14/313,742
• Publication Number:
  US 20150081001A1
• Time in Patent Office: 1,288 Days
• Field of Search: 623 111, 623 112, 623 115, 623 116, 623 135
• 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: 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 2025/1079 having radio-opaque markers in the region of the balloon

Abstract

A system for treating a bifurcation includes a first radially expandable stent and a second radially expandable stent. The first stent has a side hole and a plurality of lateral elements extending from the side hole. The second stent has a plurality of axial elements extending away from the proximal end of the second stent. The axial elements of the second stent interdigitate with the lateral elements of the first stent when both stents have been expanded.

Claims

1. A system for treating a bifurcation, the system comprising:

a first radially expandable stent comprising a proximal end, a distal end, a sidewall having a side hole therethrough, and a plurality of lateral elements extending from the side hole, wherein the first radially expandable stent has a collapsed configuration and an expanded configuration, in the collapsed configuration the first radially expandable stent being configured for delivery to the bifurcation and having a proximal portion length from the proximal end to the side hole, and in the expanded configuration the first radially expandable stent being configured to support a vessel wall adjacent the bifurcation;

a second radially expandable stent comprising a proximal end, a distal end, and a plurality of axial elements extending axially away from the proximal end of the second radially expandable stent, wherein the second radially expandable stent has a collapsed configuration and an expanded configuration, in the collapsed configuration the second radially expandable stent being configured for delivery to the bifurcation, and in the expanded configuration the second radially expandable stent being configured to support a vessel wall adjacent the bifurcation, and wherein the axial elements of the second stent are configured to interdigitate with the lateral elements of the first stent when the first stent and the second stent are in the expanded configuration;

a first delivery catheter comprising a first elongate shaft with a proximal end and a distal end, and a first expandable member adjacent the distal end of the first elongate shaft, wherein in the collapsed configuration the first stent is disposed over and coupled with the first expandable member; and

a second delivery catheter comprising a second elongate shaft with a proximal end and a distal end, and a second expandable member adjacent the distal end of the second elongate shaft and having a working length, wherein in the collapsed configuration the second radially expandable stent is disposed over and coupled with a distal portion of the working length of the second expandable member and a proximal portion of the working length of the second expandable member is unconstrained by the second radially expandable stent and extends proximally from the proximal end of the second radially expandable stent by a length greater than the proximal portion length of the first radially expandable stent, wherein a portion of the second delivery catheter is disposed under a portion of the first radially expandable stent, and a portion of the second delivery catheter passes through the side hole in the first radially expandable stent, and wherein the second delivery catheter is axially slidable relative to the first delivery catheter while the first radially expandable stent is in the collapsed configuration to position the proximal portion of the second expandable member to expand a portion of the first radially expandable stent proximal to the side hole from the collapsed configuration and align the axial elements of the second radially expandable stent with the lateral elements of the first radially expandable stent so that the axial elements and the lateral elements interdigitate when the first and second stents are expanded via expansion of the first and second expandable members.

2. The system of claim 1, wherein the first radially expandable stent or the second radially expandable stent is balloon expandable.

3. The system of claim 1, wherein the plurality of axial elements comprise a plurality of interconnected struts.

4. The system of claim 1, wherein the plurality of axial elements comprise a strut formed into a series of peaks and valleys.

5. The system of claim 1, wherein the plurality of lateral elements comprise a plurality of interconnected struts.

6. The system of claim 1, wherein the plurality of lateral elements comprise a strut formed into a series of peaks and valleys.

7. The system of claim 1, further comprising a therapeutic agent disposed on the first radially expandable stent or the second radially expandable stent, the therapeutic agent adapted to being eluted therefrom.

8. The system of claim 7, wherein the therapeutic agent comprises an anti-restenosis agent.

9. The system of claim 1, wherein the first expandable member and the second expandable member are independently expandable of one another.

10. The system of claim 1, wherein the first expandable member or the second expandable member comprises a balloon.

11. The system of claim 1, wherein the working length of the second expandable member comprises a tapered region such that a proximal portion of the tapered region has a diameter larger than a distal portion of the tapered region.

12. The system of claim 1, wherein each of the first delivery catheter and the second delivery catheter comprise a guidewire lumen.

13. The system of claim 1, wherein either the first delivery catheter or the second delivery catheter comprises a distal guidewire opening in the distal end of the respective elongate shaft, and a proximal guidewire opening,

wherein the proximal guidewire opening is spaced closer to the distal guidewire opening than the proximal end of the respective elongate shaft, and

wherein the guidewire lumen is configured to slidably receive a guidewire, and

wherein the guidewire lumen extends from the distal guidewire opening to the proximal guidewire opening.

14. The system of claim 1, wherein either the first catheter or the second catheter comprises a distal guidewire opening in the distal end of the respective elongate shaft, and a proximal guidewire opening in the proximal end of the respective elongate shaft,

wherein the proximal guidewire opening is closer to the proximal end of the respective elongate shaft than the distal guidewire opening, and

wherein the guidewire lumen in the respective elongate shaft is configured to slidably receive a guidewire, and

wherein the guidewire lumen extends from the distal guidewire opening to the proximal guidewire opening.

15. The system of claim 1, wherein the second expandable member is axially spaced apart from the first expandable member such that the second expandable member is distal to the first expandable member.

16. The system of claim 15, wherein the distal expandable member has a cross-sectional profile smaller than a cross-sectional profile of the other expandable member.

17. The system of claim 1, wherein the first radially expandable stent is non-uniformly crimped to the first expandable member.

18. The system of claim 1, wherein the second radially expandable stent is uniformly crimped to the second expandable member.

19. The system of claim 1, wherein the first elongate shaft comprises a first radiopaque marker disposed thereon, and wherein the second elongate shaft comprises a second radiopaque marker disposed thereon, such that when the first radiopaque marker is aligned with the second radiopaque marker a working portion of the first expandable member is aligned with a working portion of the second expandable member, and a proximal end of the second stent is aligned with the side hole of the first stent, and wherein the proximal portion of the second expandable member is disposed under a proximal portion of the first stent.

20. The system of claim 1, wherein expansion of the second expandable member simultaneously expands the portion of the first stent proximal to the side hole and expands the second stent.

21. The system of claim 1, wherein the first expandable member has a working length having a tapered region such that a proximal portion of the tapered region has a diameter larger than a distal portion of the tapered region.