Side branch stenting system using a main vessel constraining side branch access balloon and side branching stent

• US 20080109062A1
• Filed: 11/03/2006
• Published: 05/08/2008
• Est. Priority Date: 11/03/2006
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Chalekian, Aaron
• Granted Patent: US 8,398,695 B2
• Time in Patent Office: Days
• US Class Current: 623/1.12
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• 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 2002/821 Ostial stents
• CPC Class Codes: A61F 2002/91525 within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/91558 connected peak to peak

Abstract

A side branch stenting system using a catheter/stent assembly having a balloon with adjacent globular and cylindrical portions and a stent mounted thereon over the cylindrical portion The stent has finger-like projections mounted over portion of the globular portion of the balloon. At a bifurcation site with another stent in place in the main vessel and having an opening into a side branch, the catheter/stent assembly is placed in the side branch and inflated. The cylindrical portion of the balloon expands the main stent body in the side vessel. The globular portion of the balloon inflates in the main vessel, constraining the main vessel and bending the finger-like projections around the circumference of the opening into the side branch.

Claims

1. An assembly comprising

a catheter shaft,

a balloon mounted on the catheter shaft, the balloon having

an inflatable first chamber having a globular configuration with a maximum perpendicular dimension (D1) taken in a plane perpendicular to the longitudinal axis of the balloon and an axial length (D3) which is not more than about 20% greater than the maximum perpendicular dimension (D1), and

an inflatable adjacent second chamber having a generally cylindrical body portion which has a diameter (D2) which is less than the first chamber diameter axial length (D3).

a stent mounted on the catheter, the stent having a tubular body which includes a main body portion, and a plurality of finger-like projections, the stent mounted over the balloon such that the finger like projections are disposed over a portion of the first chamber and the main body portion is disposed over the second chamber.

2. An assembly as in claim 1 wherein the first chamber of the balloon has proximal and distal ends the maximum perpendicular dimension (D1) occurs at a location between the proximal and distal ends and the finger-like projections of the second stent extend over a portion of the first chamber from the distal end, but not beyond the location of the maximum perpendicular dimension.

3. An assembly as in claim 1 wherein the first chamber of the balloon has proximal and distal ends the maximum perpendicular dimension (D1) occurs at a location between the proximal and distal ends and the finger-like projections of the second stent extend over a portion of the first chamber from the distal end, but not beyond the location of the maximum perpendicular dimension.

4. An assembly as in claim 1 wherein the tubular wall of the first stent has a first stent diameter, and the first chamber of the balloon has an axial length (D3) at nominal inflation that is in the range of 100-150% of the first stent diameter.

6. An assembly as in claim 1 wherein the globular configuration of the first chamber of the balloon is generally spherical.

5. An assembly as in claim 5 wherein the first chamber of the balloon has an axial length (D3) at nominal inflation that is in the range of 100-120% of the first stent diameter.

7. An assembly comprising:

a first stent having a longitudinal axis, a tubular wall and a side branch projection extending at an angle to the longitudinal axis from a portion of the tubular wall, and

a catheter assembly extending through the side branch projection of the first stent, the catheter assembly comprising;

a catheter shaft,

a balloon mounted on the catheter shaft, the balloon having two adjacent independently inflatable chambers,

a first of said chambers having a globular configuration when inflated, and a second of said chambers disposed distally of the first chamber, the second chamber having a generally cylindrical configuration, and

a second stent, the second stent having a tubular body which includes a main body portion, and, a plurality of finger-like projections the second stent mounted over the balloon such that the finger like projections are disposed over a portion of the first chamber and the main body portion is disposed over the second chamber.

8. An assembly as in claim 7 wherein the first chamber of the balloon a maximum perpendicular dimension (D1) taken in a plane perpendicular to the longitudinal axis of the balloon and an axial length (D3) which is not more than about 20% greater than the maximum perpendicular dimension (D1).

9. An assembly as in claim 8 wherein, and the second chamber has a diameter (D2) which is less than the axial length (D3) of the first chamber.

10. An assembly as in claim 8 wherein the first chamber of the balloon has proximal and distal ends the maximum perpendicular dimension (D1) occurs at a location between the proximal and distal ends and the finger-like projections of the second stent extend over a portion of the first chamber from the distal end, but not beyond the location of the maximum perpendicular dimension.

11. An assembly as in claim 7 wherein the tubular wall of the first stent has a first stent diameter, and the first chamber of the balloon has an axial length (D3) at nominal inflation that is in the range of 100-150% of the first stent diameter.

12. An assembly as in claim 11 wherein the first chamber of the balloon has an axial length (D3) at nominal inflation that is in the range of 100-120% of the first stent diameter.

13. An assembly as in claim 7 wherein the globular configuration of the first chamber of the balloon is generally spherical.

14. An assembly as in claim 7 wherein the first chamber of the balloon has a proximal end attached to the catheter in everted form.

15. An assembly as in claim 7 wherein at least the second chamber of the balloon is expanded.

16. An assembly as in claim 7 wherein the first and second chambers of the balloon are expanded.

17. An assembly as in claim 7 wherein the first stent includes a frame opening interface between the tubular wall and the side branch projection and the finger-like projections of the second stent are bent around the frame into engagement with the tubular wall of the first stent.

18. A two-stent assembly comprising:

a first stent having a tubular wall with a longitudinal axis, a side branch projection extending at an angle to the longitudinal axis from a portion of the tubular wall, with an side branch opening in the tubular wall into the side branch projection, and

a second stent having a longitudinal axis extending through and overlapping the side branch projection of the first stent, the second stent having a plurality of finger-like projections at one end bent around the side branch opening to engage the tubular wall of the first stent.

19. A two-stent assembly as in claim 18 wherein the first stent includes a frame opening interface between the tubular wall and the side branch projection and the finger-like projections of the second stent are bent around the frame into engagement with the inner wall of the first stent.

20. A method for deploying a stent assembly at a bifurcation comprising first, second and third vessels, a main channel between the first and second vessels and an ostium into the third vessel, the method comprising:

deploying a first stent in said main-channel between the first and second vessels to engage the vessel walls thereof and cross the ostium with a side branch projection extending through the ostium into the third vessel,

providing a second stent which overlaps and extends beyond the side branch projection of the first stent in the third vessel, the second stent having a plurality of finger-like projections extending into the main-channel,

expanding the second stent to engage the vessel wall of the third vessel, and

bending said finger-like projections of the second stent around the perimeter of the ostium to engage the first stent in the main channel and provide for a linked assembly of the two stents.

21. A method as in claim 20 wherein, in said step of providing a second stent, the second stent is provided mounted on a balloon catheter, the balloon catheter having a balloon that has two adjacent independently inflatable chambers, a first of said chambers having a globular configuration when inflated, and a second of said chambers disposed distally of the first chamber, the second chamber having a generally cylindrical configuration, and the second stent, is mounted over the balloon such that the finger like projections are disposed over a portion of the first chamber and the main body portion is disposed over the second chamber.

22. A method as in claim 21 wherein the steps of expanding the second stent and of bending said finger-like portions of the second step comprise first inflating the second chamber of the balloon and then inflating the first chamber of the balloon.

23. A method as in claim 22 wherein the first chamber of the balloon is inflated to fill the main channel and support the circumference of the ostium.