BULGING BALLOON FOR BIFURCATION CATHETER ASSEMBLY AND METHODS

• US 20090163879A1
• Filed: 08/27/2008
• Published: 06/25/2009
• Est. Priority Date: 08/27/2007
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: ANDERSON, JAMES M., JAGGER, KARL, WEBER, JAN
• Granted Patent: US 8,333,795 B2
• Time in Patent Office: Days
• US Class Current: 604/264
• 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 2002/91525 within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
• CPC Class Codes: A61F 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2250/0015 differing in density or specific weight
• CPC Class Codes: A61F 2250/0039 differing in diameter
• 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 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• CPC Class Codes: A61M 2025/1088 having special surface characteristics depending on material properties or added substances, e.g. for reducing friction
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1027 Making of balloon catheters
• CPC Class Codes: A61M 25/1029 Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A catheter assembly adapted to treat a vessel bifurcation. A balloon member of the catheter assembly includes a main body portion and a cylindrical shaped bulge portion that extends radially outward from the main body portion. The bulge portion extends around a circumference of the main body portion. A stent of the catheter assembly is typically mounted to the balloon member. When treating the vessel bifurcation, the catheter assembly is positioned with the bulge portion aligned axially relative to an ostium of the branch vessel. The balloon member is inflated to expand a portion of the stent into the branch vessel. The circumferential construction of the bulge portion of the balloon member reduces the need for radial (rotational) alignment of the balloon member relative to the ostium of the branch vessel.

Claims

1. A catheter assembly, comprising:

(a) a stent, the stent defining an interior volume and having a distal open end, a proximal open end, and expandable strut structure defining a sidewall of the stent; and

(b) a catheter branch assembly, including;

(i) a catheter shaft having a distal end portion; and

(ii) a balloon member extending from the distal end portion of the catheter shaft, the balloon member having a main body portion and a bulge portion when the balloon member is inflated, the main body portion having a distal end portion and a proximal end portion, the bulge portion positioned at a location between the distal and proximal end portion of the main body portion, the bulge portion configured to expand the stent in a radial outward direction relative to the sidewall of the stent when inflated.

2. The catheter assembly of claim 1, further comprising a sleeve positioned on the balloon member, the sleeve configured to restrict inflation of the main body portion and not restriction inflation of the bulge portion of the balloon member.

3. The catheter assembly of claim 2, wherein the sleeve includes a distal portion and a proximal portion, the distal and proximal portions being spaced apart axially along a length of the balloon member.

4. The catheter assembly of claim 2, wherein the sleeve includes a plurality of axially arranged slits, the slits arranged in axial alignment with the bulge portion of the balloon member.

5. The catheter assembly of claim 1, wherein the stent includes an expandable structure zone, wherein the struts in the expandable structure zone are configured different from the struts not in the expandable structure zone, and the expandable structure zone extends around a circumference of the stent.

6. A catheter branch assembly, comprising:

(a) a catheter shaft having a distal end portion;

(b) a balloon member extending from the distal end portion of the catheter shaft, the balloon member having a main body portion, the main body portion having a distal end portion and a proximal end portion;

(c) a guidewire housing extending through the catheter shaft and the balloon member; and

(d) a sleeve positioned on the balloon member, the sleeve having a distal portion and a proximal portion axially spaced apart along a length of the main body portion of the balloon member, the distal and proximal portions of the sheath configured to restrict radial expansion of the distal and proximal end portions of the maim body portion, and the sleeve configured to provide less restriction to radial expansion of that portion of the main body portion exposed at a location between the axially spaced apart distal and proximal portions of the sleeve.

7. The catheter branch assembly of claim 6, wherein the sleeve includes a plurality of axially arranged slits formed therein at a position located between the proximal and distal portions thereof, the slits defining a plurality of axially arranged sleeve strips.

8. The catheter branch assembly of claim 6, wherein the proximal portion of the sleeve has a distal end, and the distal portion of the sleeve has a proximal end, the distal end of the proximal portion being spaced apart from the proximal end of the distal portion a distance sufficient for the main body portion of the balloon member to expand radially outward relative to the sleeve to create a balloon bulge portion when the balloon member is inflated.

9. The catheter branch assembly of claim 6, wherein the sleeve includes a plurality of helical slits formed therein.

10. The catheter branch assembly of claim 6, wherein the sleeve includes stiffening fibers aligned along a length of the sleeve.

11. A balloon catheter, comprising:

(a) a catheter shaft, the catheter shaft having a distal end portion; and

(b) a balloon member positioned at the distal end portion of the catheter shaft, the balloon member having a main body portion and a bulge portion, the main body portion having a proximal end portion, a distal end portion, and an outer surface that defines a circumference of the main body portion, the main body portion having a maximum width dimension when the balloon member is inflated, the bulge portion positioned at a location between the proximal and distal end portions of the main body portion, the bulge portion extending around the circumference of the main body portion and having a maximum width dimension when the balloon member is inflated that is greater than the maximum width dimension of the main body portion.

12. The balloon catheter of claim 11, further comprising a guidewire housing positioned within the catheter shaft and the balloon member, the guidewire housing having a distal end portion that extends distally from the distal end portion of the catheter shaft and the distal end portion of the balloon member.

13. The balloon catheter of claim 11, wherein the main balloon portion has a total length and the bulge balloon portion has a length, and the length of the bulge balloon portion is less than the total length of the main balloon portion.

14. The balloon catheter of claim 11, wherein the width of the main balloon portion is about 1.5 mm to about 2.5 mm, and the width of the bulge balloon portion is in about 3.5 mm to about 4.5 mm.

15. The balloon catheter of claim 11, wherein the bulge balloon portion is positioned at a location substantially equidistant from the distal and proximal end portions of the main balloon portion.

16. The balloon catheter of claim 11, wherein the main balloon portion and the bulge balloon portion are formed integral with each other.

17. A method of expanding a stent with a catheter assembly, the catheter assembly including a catheter branch assembly having a balloon member, the balloon member including a main balloon portion and a bulge portion that extends around a circumference of the main balloon portion, the bulge portion having a maximum radial dimension greater than a maximum radial dimension of the main balloon portion, the stent being positioned on the balloon, the stent having a main body portion and an expandable structure portion, the method comprising:

(a) inflating the balloon member; and

(b) expanding the expandable structure portion of the stent in a radial outward direction with the inflated bulge portion of the balloon member.

18. The method of claim 17, further comprising expanding the main body portion of the stent, wherein a maximum expanded dimension of the expanded expandable structure portion of the stent is greater than a maximum expanded dimension of the main body portion of the stent.

19. A method of treating a vessel bifurcation with a catheter assembly, the catheter assembly including a guidewire, a catheter branch, and a stent, the catheter branch including a balloon member having a main balloon portion and a bulge portion, the bulge portion extending around a circumference of the main balloon portion and positioned at a location between proximal and distal end portions of the main balloon portion, the stent positioned on the balloon member in alignment with the bulge portion, the method comprising:

(a) advancing the guidewire into a main vessel of the vessel bifurcation distally beyond an ostium of a branch vessel of the vessel bifurcation;

(b) advancing the catheter branch and stent over the guidewire to the vessel bifurcation with the bulge portion of the balloon member axially aligned with the ostium of the branch vessel;

(c) inflating the balloon member to expand at least a portion of the stent through the ostium into the branch vessel;

(d) retracting the catheter branch proximally;

(e) retracting the guidewire proximal of the ostium;

(f) advancing the guidewire through the portion of the expanded stent and into the branch vessel;

(g) advancing a secondary balloon catheter over the guidewire and through the portion of the expanded stent; and

(h) further expanding the portion of the stent with the secondary balloon catheter.

20. A method of treating a vessel bifurcation with a catheter assembly, the catheter assembly including a guidewire, a catheter branch, and a stent, the catheter branch including a balloon member having a main balloon portion and a bulge portion, the bulge portion extending around a circumference of the main balloon portion and positioned at a location between proximal and distal end portions of the main balloon portion, the method comprising:

(a) advancing the guidewire into a main vessel of the vessel bifurcation distally beyond an ostium of a branch vessel of the vessel bifurcation;

(b) positioning the stent in the main vessel spanning the ostium;

(c) expanding the stent into engagement with the main vessel;

(d) advancing the catheter branch over the guidewire to the vessel bifurcation with the bulge portion of the balloon member axially aligned with the ostium of the branch vessel;

(e) inflating the balloon member to expand at least a portion of the stent through the ostium into the branch vessel;

(f) retracting the catheter branch proximally;

(g) retracting the guidewire proximal of the ostium;

(h) advancing the guidewire through the portion of the expanded stent and into the branch vessel;

(i) advancing a secondary balloon catheter over the guidewire and through the portion of the expanded stent; and

(j) further expanding the portion of the stent with the secondary balloon catheter.