Bulging balloon for bifurcation catheter assembly and methods

• US 8,333,795 B2
• Filed: 08/27/2008
• Issued: 12/18/2012
• 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: Weber, Jan, Anderson, James M., Jagger, Karl
• Primary Examiner(s): HOLWERDA, KATHLEEN SONNETT
• Application Number:
  US12/199,674
• Publication Number:
  US 20090163879A1
• Time in Patent Office: 1,574 Days
• Field of Search: 606/159, 606/108, 606191-200, 623 111- 154, 604/103.05, 604/103.08, 604/103.09, 604/103.06, 604/103.07
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• CPC Class Codes: A61F 2/91 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 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 that, when unrestricted, has a generally constant diameter, the main body portion having a distal portion, a proximal portion, and an intermediate portion between the distal portion and the proximal portion;

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

(d) a continuous one-piece sleeve positioned on the balloon member, at least a portion of the sleeve including a plurality of slits formed therein, the slits disposed around the circumference of the sleeve, 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 portion and the proximal portion of the sleeve configured to expand while restricting radial expansion of the distal portion and the proximal portion of the main body portion to a first diameter, and the sleeve configured to provide less restriction to radial expansion of the intermediate portion of the main body portion positioned at a location between the axially spaced apart distal and proximal portions of the sleeve such that the intermediate portion of the main body portion expands substantially uniformly about its circumference to a second diameter that is larger than the first diameter, wherein the balloon extends proximally beyond a proximal end of the sleeve and distally beyond a distal end of the sleeve.

2. The catheter branch assembly of claim 1, wherein the plurality of slits are arranged axially at a position located between the proximal and distal portions thereof, the slits defining a plurality of axially arranged sleeve strips, wherein the sleeve strips are continuous with the proximal and distal portions of the sleeve.

3. The catheter branch assembly of claim 1, 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.

4. The catheter branch assembly of claim 1, wherein the plurality of slits are helical.

5. The catheter branch assembly of claim 1, wherein the sleeve includes stiffening fibers aligned along a length of the sleeve.