Methods and systems for ostial stenting of a bifurcation

• US 9,724,218 B2
• Filed: 07/01/2014
• Issued: 08/08/2017
• 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:
  US14/321,506
• Publication Number:
  US 20150032196A1
• Time in Patent Office: 1,134 Days
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/9524 Iris-type crimpers
• 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 2/97 the outer sleeve being splittable
• CPC Class Codes: A61F 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• 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: Y10T 29/49908 Joining by deforming
• CPC Class Codes: Y10T 29/49913 by constricting outer annulus

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 proximal portion of the stent in a main branch vessel, and expansion of the second expandable member expands a distal portion of the stent in a side branch vessel.

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 wall of a main branch of the bifurcation and a wall of a side branch of the bifurcation, 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 a proximal portion of the stent, and the first elongate shaft passes through the side hole so that a second portion of the first elongate shaft is disposed over a distal portion of the stent and the first expandable member is axially spaced apart from the second expandable member such that the first expandable member is distal to the second expandable member for concurrent advancement of the first and second delivery catheters to the bifurcation, wherein the first elongate shaft is axially slidable relative to the second elongate shaft while the stent is in the collapsed configuration, and wherein the first expandable member includes a proximal working portion and a distal 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 the main branch distal to the side branch 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 the first expandable member has a cross-sectional profile smaller than a cross-sectional profile of the second expandable member.

5. 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.

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

7. The system of claim 1, wherein the stent is non-uniformly crimped to the second expandable member 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.

8. 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.

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

10. 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.

11. The system of claim 10, 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.

12. 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.

13. 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.

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

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