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

• US 10,406,010 B2
• Filed: 12/16/2015
• Issued: 09/10/2019
• 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): Schwiker, Katherine H
• Application Number:
  US14/971,615
• Publication Number:
  US 20160100966A1
• Time in Patent Office: 1,364 Days
• 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 system for treating a bifurcated vessel in a patient, the bifurcated vessel having a main branch and a side branch, the system comprising:

a first delivery catheter carrying a first stent, the first stent comprising a proximal stent and a distal stent, the first delivery catheter also having a first elongate shaft with a proximal end, a distal end, a lumen extending through the first elongate shaft, a discrete proximal expandable member with the proximal stent disposed thereover, and a discrete distal expandable member with the distal stent disposed thereover, the proximal and distal expandable members disposed adjacent the distal end of the first elongate shaft,

wherein the proximal and distal expandable members each have a collapsed configuration and a radially expanded configuration, the collapsed configuration of the proximal and distal expandable members having a profile suitable for advancement through a blood vessel, and the expanded configuration of the proximal and distal expandable members having a larger profile than the profile of the collapsed configuration of the proximal and distal expandable members, and

wherein the proximal and distal stents are two discrete stents, and wherein a proximal end of the distal stent has a notched region and a distal end of the proximal stent has notched region such that when the notched regions are adjacent one another a side hole is formed in the first stent,

wherein the proximal and distal stents each have a collapsed configuration suitable for delivery to the bifurcation and a radially expanded configuration adapted to engage and support a vessel wall at the bifurcation or adjacent thereto,

wherein the proximal and distal expandable members are independently expandable of one another; and

a second delivery catheter carrying a second stent, the second stent being a discrete stent, the second delivery catheter also having a second elongate shaft with a proximal end, a distal end, and a second expandable member with the second stent disposed thereover, the second expandable member disposed adjacent the distal end of the second elongate shaft,

wherein the second expandable member has a collapsed configuration and a radially expanded configuration, the collapsed configuration of the second expandable member having a profile suitable for advancement through a blood vessel, and the expanded configuration of the second expandable member having a larger profile than the profile in the collapsed configuration of the second expandable member,

wherein the second elongate shaft is slidably disposed in the lumen of the first elongate shaft and passes through the side hole in the first stent when the proximal and distal stents are in the collapsed configuration of the proximal and distal stents and when the proximal and distal expandable members are in the collapsed configuration of the proximal and distal expandable members, and

wherein the second expandable member is independently expandable of the proximal and the distal expandable members.

2. The system of claim 1, wherein the first delivery catheter is adapted to deliver the proximal and distal stents to the main branch adjacent the bifurcation.

3. The system of claim 1, wherein the second delivery catheter is adapted to deliver the second stent to the side branch adjacent the bifurcation.

4. The system of claim 1, wherein a portion of the second delivery catheter is disposed under a portion of the proximal stent.

5. The system of claim 1, wherein the second stent has a collapsed configuration suitable for delivery to the bifurcation, and a radially expanded configuration adapted to engage and support a vessel wall at the bifurcation or adjacent thereto.

6. The system of claim 5, wherein in the radially expanded configuration of the proximal, distal and second stents, a proximal end of the second stent is configured to align with and abut a side of the proximal stent and a side of the distal stent.

7. The system of claim 1, wherein the proximal stent, the distal stent, and the second stent are crimped to the proximal expandable member, the distal expandable member, and the second expandable member respectively so as to prevent ejection thereof during advancement through a patient'"'"'s vasculature.

8. The system of claim 1, wherein in the collapsed configuration of the proximal and distal stents, the proximal end of the distal stent abuts the distal end of the proximal stent.

9. The system of claim 1, wherein a proximal end of the second stent comprises a beveled section adapted to fit flush against a sidewall of the proximal stent or a sidewall of the distal stent.

10. The system of claim 1, wherein a gap separates the proximal and distal expandable members when both the proximal and distal expandable members are in the collapsed configuration of the proximal and distal expandable members, the gap being disposed between a proximal end of the distal expandable member and a distal end of the proximal expandable member.

11. The system of claim 10, wherein expansion of the proximal and distal expandable members displaces the proximal end of the distal expandable member relative to the distal end of the proximal expandable member so that the proximal end of the distal expandable member advances toward the distal end of the proximal expandable member to decrease the gap between the proximal and distal expandable members.

12. The system of claim 11, wherein the proximal end of the distal expandable member abuts the distal end of the proximal expandable member when both the proximal and the distal expandable members are in the expanded configuration of the proximal and distal expandable members.

13. The system of claim 1, wherein the proximal expandable member, the distal expandable member, or the second expandable member comprises a balloon.

14. The system of claim 1, wherein in the radially expanded configuration of the proximal, distal and second expandable members, a proximal end of the second expandable member abuts a side of both the proximal and the distal expandable members.

15. The system of claim 1, wherein the first elongate shaft comprises a guidewire lumen extending at least partially from the proximal end thereof to the distal end thereof, the first elongate shaft comprising a proximal guidewire port and a distal guidewire port adjacent the distal end thereof, wherein the proximal guidewire port is closer to the proximal end of the first elongate shaft than the distal end of the first elongate shaft.

16. The system of claim 1, wherein the first elongate shaft comprises a guidewire lumen extending at least partially from the proximal end thereof to the distal end thereof, the first elongate shaft comprising a proximal guidewire port and a distal guidewire port adjacent the distal end thereof, wherein the proximal guidewire port is closer to the distal guidewire port than the proximal end of the first elongate shaft.

17. The system of claim 1, wherein the second elongate shaft comprises a guidewire lumen extending at least partially from the proximal end thereof to the distal end thereof, the second elongate shaft comprising a proximal guidewire port and a distal guidewire port adjacent the distal end thereof, wherein the proximal guidewire port is closer to the proximal end of the second elongate shaft than the distal end of the second elongate shaft.

18. The system of claim 1, wherein the second elongate shaft comprises a guidewire lumen extending at least partially from the proximal end thereof to the distal end thereof, the second elongate shaft comprising a proximal guidewire port and a distal guidewire port adjacent the distal end thereof, wherein the proximal guidewire port is closer to the distal guidewire port than the proximal end of the second elongate shaft.