Methods and systems for treating a bifurcation with provisional side branch stenting

• US 8,795,347 B2
• Filed: 03/24/2011
• Issued: 08/05/2014
• 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): Erezo, Darwin
• Assistant Examiner(s): HOLLM, JONATHAN A
• Application Number:
  US13/071,198
• Publication Number:
  US 20110307045A1
• Time in Patent Office: 1,230 Days
• Field of Search: 606/108, 623/1.11, 623/1.12, 623/1.15, 623/1.16, 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 2/86 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 2/91 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 2/954 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 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• 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
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence

Abstract

A system for treating a bifurcation includes first and second delivery catheters, each having an expandable member. A stent having a side hole is disposed on the second delivery catheter. A portion of the first delivery catheter is disposed under a portion of the stent. The first delivery catheter is slidable relative to the second delivery catheter, and the first delivery catheter passes through the side hole. Expansion of the first expandable member expands a portion of the stent and expansion of the second expandable member expands the rest of the stent.

Claims

1. A method of treating a bifurcated vessel, said method comprising:

providing a first delivery catheter and a second delivery catheter in a delivery configuration, wherein the first delivery catheter comprises a first elongate shaft, and a first expandable member, and the second delivery catheter comprises a second elongate shaft, a second expandable member, and a stent having a side hole, the stent disposed over the second expandable member, and wherein a portion of the first elongate shaft is disposed under the stent and the first elongate shaft exits the side hole in the stent, the first expandable member being distal to the second expandable member and the first expandable member not having a stent mounted thereon in the delivery configuration;

advancing both the first delivery catheter and the second delivery catheter concurrently in the delivery configuration through a main branch vessel having a lesion to a bifurcation in the main branch, the bifurcation comprising a side branch vessel extending from the main branch vessel, wherein the stent is advanced until the stent is in the main branch and traverses the main branch lesion, and the side hole is adjacent the ostium to the side branch, and the first expandable member is disposed in the side branch;

proximally retracting the first elongate shaft under a portion of the stent so that the first expandable member moves proximally from distal of the bifurcation until the first expandable member is disposed under the stent while another portion of the first expandable member is disposed in the side branch prior to expanding the second expandable member;

radially expanding the first expandable member while the first expandable member is disposed under the stent and the other portion is disposed in the side branch, thereby expanding a proximal portion of the stent into engagement with the lesion in the main branch and expanding the side hole while a distal portion of the stent remains unexpanded; and

radially expanding the second expandable member, thereby expanding a distal portion of the stent into engagement with the lesion in the main branch and the wall of the main branch.

2. The method of claim 1, wherein the advancing comprises advancing both the first and the second delivery catheters until resistance to further advancement is felt by an operator.

3. The method of claim 2, wherein the resistance is provided by separation of the first elongate shaft from the second elongate shaft as both shafts are advanced against a wall formed between the main branch and the side branch.

4. The method of claim 1, wherein the first delivery catheter comprises a first radiopaque marker disposed adjacent a proximal region of the first expandable member, and the second delivery catheter comprises a second radiopaque marker disposed adjacent a proximal region of the second expandable member, and wherein the retracting comprises retracting the first elongate shaft until the first radiopaque marker is aligned with the second radiopaque marker.

5. The method of claim 1, wherein the second elongate shaft comprises an exchange lumen, and the retracting comprises slidably retracting the first elongate shaft through the exchange lumen.

6. The method of claim 1, wherein the first elongate shaft and the second elongate shaft are disposed in a central channel of a capture tube, and the retracting comprises slidably retracting the first elongate shaft through the central channel.

7. The method of claim 6, wherein the capture tube comprises a perforated region, the method further comprising separating the perforated region and peeling the capture tube away from the first and the second elongate shafts.

8. The method of claim 1, wherein the second elongate shaft comprises a snap fitting configured to receive and retain the first elongate shaft, and wherein the retracting comprises slidably retracting the first elongate shaft along the snap fitting.

9. The method of claim 1, wherein the first elongate shaft and the second elongate shaft are disposed in a polymer tube having a central channel therethrough, and the retracting comprises slidably retracting the first elongate shaft through the central channel.

10. The method of claim 1, wherein the first expandable member comprises a balloon, and the expanding of the first expandable member comprises inflating the balloon.

11. The method of claim 1, further comprising contracting the first expandable member after expansion thereof and prior to the expansion of the second expandable member.

12. The method of claim 1, wherein expanding the proximal or distal portion of the stent comprises differentially expanding the stent so that a proximal region of the expanded stent has a larger diameter than a distal region of the expanded stent.

13. The method of claim 1, wherein the second expandable member comprises a balloon, and the expanding of the second expandable member comprises inflating the balloon.

14. The method of claim 1, further comprising simultaneously expanding the first and the second expandable members into engagement with one another thereby ensuring engagement of the stent with the lesion in the main branch and walls of the main branch, and ensuring alignment of the side hole in the stent with the side branch.

15. The method of claim 1, wherein the main branch and the side branch have substantially similar diameters.

16. The method of claim 1, further comprising eluting a therapeutic agent from the stent or the first expandable member or the second expandable member into the main branch lesion or the side branch.

17. The method of claim 16, wherein the therapeutic agent comprises an anti-restenosis agent.