Methods and systems for ostial stenting of a bifurcation

• US 8,828,071 B2
• Filed: 03/24/2011
• Issued: 09/09/2014
• 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:
  US13/071,162
• Publication Number:
  US 20110307044A1
• Time in Patent Office: 1,265 Days
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• CPC Class Codes: A61F 2/9522 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 method of treating a bifurcated vessel, said method comprising:

providing a first delivery catheter and a second delivery catheter,

wherein the first delivery catheter comprises a first elongate shaft, and a first expandable member near a distal end of the first elongate shaft, and

wherein the second delivery catheter comprises a second elongate shaft, a second expandable member near a distal end of the second elongate shaft, and a stent disposed over the second expandable member, the stent having a sidewall with a side hole therethrough,

wherein the a portion of the first elongate shaft is disposed under the stent and the first elongate shaft passes through the side hole in the stent, and

wherein the first expandable member is distal to the second expandable member;

advancing both the first delivery catheter and the second delivery catheter through a vessel toward the bifurcation while the first expandable member is distal to the second expandable member, wherein the bifurcation comprises a main branch vessel having a main branch lesion and a side branch extending from the main branch and having a side branch lesion,

wherein the stent is advanced until the stent is disposed in both the main branch and in the side branch, and

wherein the first expandable member is advanced until the first expandable member is disposed in the main branch past the bifurcation with a proximal working end of the first expandable member distal of the side hole of the stent;

proximally retracting the first elongate shaft relative to the second elongate shaft so that the first elongate shaft is retracted under a proximal portion of the stent, the proximal working end of the first expandable member is proximal of a proximal end of the stent, and a portion of the first expandable member is disposed under the stent while another portion of the first expandable member remains unconstrained by the stent and disposed in the main branch distal to the side hole in the stent;

radially expanding the first expandable member thereby expanding the proximal portion of the stent into engagement with the main branch lesion and a wall of the main branch, and expanding the side hole; and

radially expanding the second expandable member thereby expanding a distal portion of the stent into engagement with the lesion in the side branch and a wall of the side 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 carina 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 or the second expandable member comprises a balloon, and the expanding of the corresponding 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 the stent is differentially expanded so that a proximal region of the stent has a larger diameter than a distal region of the stent.

13. 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 a proximal portion of the stent with the lesion in the main branch, and engagement of a distal portion of the stent with the lesion in the side branch, and ensuring alignment of the side hole in the stent with the main branch.

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

15. The method of claim 1, further comprising eluting a therapeutic agent from the stent or one of the expandable members into the main branch lesion or the side branch lesion.

16. The method of claim 15, wherein the therapeutic agent comprises an anti-restenosis agent.