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

• US 9,730,821 B2
• Filed: 06/25/2014
• Issued: 08/15/2017
• Est. Priority Date: 09/25/2008
• Status: Active Grant

• Current Assignee: Advanced Bifurcation Systems, Inc.
• Original Assignee: Advanced Bifurcation Systems, Inc.
• Inventors: Khorsandi, Mehran, Bourang, Henry
• Primary Examiner(s): Nguyen, Victor
• Assistant Examiner(s): HOLLM, JONATHAN A
• Application Number:
  US14/314,361
• Publication Number:
  US 20150081002A1
• Time in Patent Office: 1,147 Days
• Field of Search: 623 111, 623 112, 623 115, 623 116
• 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 system for treating a bifurcation, the system comprising:

a first delivery catheter comprising a first elongate shaft with proximal and distal ends, and a first expandable member adjacent the distal end of the first elongate shaft; and

a second delivery catheter comprising a second elongate shaft with proximal and distal ends, a second expandable member adjacent the distal end of the second elongate shaft, and a radially expandable stent disposed over the second expandable member,

wherein the stent comprises a sidewall having a side hole therethrough; and

wherein the stent has a collapsed configuration suitable for delivery to the bifurcation, an expanded configuration in which the stent is configured to support a vessel, a proximal end, and a proximal portion extending along a proximal portion length from the proximal end to the side hole in the collapsed configuration; and

wherein a first portion of the first elongate shaft is disposed under the proximal portion of the stent, and the first elongate shaft passes through the side hole so that the first expandable member is disposed distal to the second expandable member for concurrent advancement of the first and second delivery catheters through the vessel, wherein the first elongate shaft is proximally retractable relative to the second elongate shaft while the stent is in the collapsed configuration to retract the first expandable member through the side hole into the proximal portion of the stent, and wherein the first expandable member includes a proximal working portion and a distal working portion distal to the proximal working portion, the proximal working portion having a length greater than the proximal portion length of the stent in the collapsed configuration, the distal working portion having a length sufficient so that the distal working portion extends into a branch of the bifurcation when a proximal end of the proximal working portion is positioned proximal to the proximal end of the stent in the collapsed configuration.

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

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

4. The system of claim 1, wherein each of the first delivery catheter and the second delivery catheter comprise an inflation lumen.

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

6. The system of claim 5, wherein the first delivery catheter comprises a distal guidewire opening in the distal end of the first elongate shaft, and a proximal guidewire opening, the proximal guidewire opening spaced closer to the distal guidewire opening than the proximal end of the first elongate shaft, and

wherein the guidewire lumen in the first delivery catheter is configured to slidably receive a guidewire, the guidewire lumen in the first delivery catheter extending from the distal guidewire opening to the proximal guidewire opening.

7. The system of claim 5, wherein the second delivery catheter comprises a distal guidewire opening in the distal end of the second elongate shaft, and a proximal guidewire opening, the proximal guidewire opening spaced closer to the distal guidewire opening than the proximal end of the second elongate shaft, and

wherein the guidewire lumen in the second delivery catheter is configured to slidably receive a guidewire, the guidewire lumen in the second delivery catheter extending from the distal guidewire opening to the proximal guidewire opening.

8. The system of claim 5, wherein the first delivery catheter comprises a distal guidewire opening in the distal end of the first elongate shaft, and a proximal guidewire opening in the proximal end of the first elongate shaft such that the proximal guidewire opening is closer to the proximal end of the first elongate shaft than the distal guidewire opening, and

wherein the guidewire lumen in the first delivery catheter is configured to slidably receive a guidewire, the guidewire lumen in the first delivery catheter extending from the distal guidewire opening to the proximal guidewire opening.

9. The system of claim 5, wherein the second delivery catheter comprises a distal guidewire opening in the distal end of the second elongate shaft, and a proximal guidewire opening in the proximal end of the second elongate shaft such that the proximal guidewire opening is closer to the proximal end of the second elongate shaft than the distal guidewire opening, and

wherein the guidewire lumen in the second delivery catheter is configured to slidably receive a guidewire, the guidewire lumen in the second delivery catheter extending from the distal guidewire opening to the proximal guidewire opening.

10. The system of claim 1, wherein the first expandable member has a cross-sectional profile smaller than a cross-sectional profile of the second expandable member.

11. The system of claim 1, wherein one of the first elongate shaft or the second elongate shaft comprises a region having a guidewire lumen, an inflation lumen, and an exchange lumen,

wherein the other elongate shaft is slidably disposed in the exchange lumen, and

wherein the expandable member on the other elongate shaft is axially spaced apart from the elongate shaft having the exchange lumen such that the expandable member on the other shaft is distal to the expandable member on the elongate shaft with the exchange lumen.

12. The system of claim 1, further comprising a capture tube having a proximal end, a distal end, a longitudinal axis, and a central channel extending between the capture tube proximal and distal ends, wherein the first elongate shaft and the second elongate shaft are slidably disposed in the central channel, and wherein the capture tube prevents the first elongate shaft from tangling with the second elongate shaft.

13. The system of claim 12, wherein the capture tube comprises a perforated region extending along the longitudinal axis, the perforated region extending at least partially between the proximal and distal ends of the capture tube so that the capture tube may be peeled away from the first and second elongate shafts.

14. The system of claim 12, wherein the capture tube comprises a locking mechanism for releasably holding the first elongate shaft and the second elongate shaft.

15. The system of claim 1, wherein one of the first elongate shaft or the second elongate shaft comprises a snap fitting configured to receive and retain the other elongate shaft, and wherein the other elongate shaft is slidably movable axially through the snap fitting, and wherein the expandable member on the other elongate shaft is axially spaced apart from the elongate shaft having the snap fitting such that the expandable member on the other elongate shaft is distal to the expandable member on the elongate shaft with the snap fitting.

16. The system of claim 1, further comprising a polymer sleeve having a proximal end, a distal end, a longitudinal axis, and a central channel extending between the polymer sleeve proximal and distal ends, wherein the first elongate shaft and the second elongate shaft are slidably disposed in the central channel, and wherein the polymer sleeve prevents the first elongate shaft from tangling with the second elongate shaft.

17. The system of claim 1, wherein the stent is balloon expandable.

18. The system of claim 1, wherein the stent is non-uniformly crimped around the second expandable member and the first elongate shaft such that a first sector of the proximal portion is embedded into the second expandable member and a second sector of the proximal portion is not embedded into the first elongate shaft and has a smaller profile radius than the first sector, the first elongate shaft being proximally retractable relative to the second expandable member and the first stent in the crimped configuration to position the first expandable member within the proximal portion of the stent.

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

20. The system of claim 19, wherein the therapeutic agent comprises an anti-restenosis agent.

21. The system of claim 1, wherein the first elongate shaft comprises a radiopaque marker disposed thereon, and wherein the second elongate shaft comprises a 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.

22. The system of claim 21, wherein the first expandable member or the second expandable member comprises a working length, the working length comprising a tapered region, wherein a proximal portion of the tapered region has a diameter larger than a distal portion of the tapered region.

23. The system of claim 1, wherein either the first expandable member or the second expandable member is differentially expandable such that a proximal portion of the differentially expandable member has a larger diameter than a distal portion of the differentially expandable member.

24. The system of claim 1, wherein the stent is differentially expandable such that in the expanded configuration a first portion of the stent has a larger diameter than a second portion of the stent.

25. The system of claim 1, wherein the first delivery catheter comprises a first guidewire lumen extending at least partially between the proximal and distal ends of the first elongate shaft, the system further comprising a first guidewire, the first guidewire slidably positioned in the first guidewire lumen.

26. The system of claim 1, wherein the second delivery catheter comprises a second guidewire lumen extending at least partially between the proximal and distal ends of the second elongate shaft, the system further comprising a second guidewire, the second guidewire slidably positioned in the second guidewire lumen.

27. The system of claim 1, further comprising a guidewire fixedly attached to the distal end of either the first elongate shaft or the second elongate shaft.

28. The system of claim 1, wherein the proximal portion of the stent, in the crimped configuration, has a figure eight cross-sectional shape or a pear shaped cross-sectional shape.