Deflatable bifurcated device

• US 8,827,954 B2
• Filed: 06/05/2009
• Issued: 09/09/2014
• Est. Priority Date: 06/05/2008
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Dunn, Richard, Hoff, Steve, Holman, Thomas
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): Zhang, Jenna
• Application Number:
  US12/479,632
• Publication Number:
  US 20100114019A1
• Time in Patent Office: 1,922 Days
• Field of Search: 60410101-10105, 60410306-10314, 604/916, 604/919, 623 127- 129, 623/1.35
• US Class Current: 604/103.06
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• 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 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2250/0029 differing in bending or flexure capacity
• 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 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: Y10T 29/49716 Converting

Abstract

A medical device for insertion and expansion within a bifurcated lumen is described. An expansion region of the device has regions thereon which, in some cases, enable the device to fold into a predetermined configuration upon deflation. The regions may be defined by differing modulus of the device material.

Claims

1. A method of forming a medical device for treating a bifurcated lumen, the method comprising:

providing a balloon system disposed about a distal region of a catheter shaft, the balloon system including a first inflatable portion along a longitudinal axis of the catheter shaft and a second inflatable portion offset from the longitudinal axis of the catheter shaft, the second inflatable portion of including a polymer; and

modifying a region of the second inflatable portion of the balloon system to form a first section and a second section in the second inflatable portion, the second section having a greater crystallinity than the first section such that the first section is more flexible than the second section, wherein the second inflatable portion includes a plurality of alternating first and second sections forming a striped pattern, wherein the second section stripes have a width of about 0.1 mm to about 0.5 mm, wherein the striped pattern is formed at an oblique angle to the longitudinal axis of the catheter shaft.

2. The method of claim 1 wherein the modifying includes directing radiation at the region of the second inflatable portion.

3. The method of claim 2 wherein directing radiation includes directing radiation that has a fluence below an ablation threshold to form the second section.

4. The method of claim 2 wherein directing radiation includes directing radiation that has a fluence above an ablation threshold to form the first section.

5. The method of claim 1 wherein the first section and second section cause the second inflatable portion to be collapsible into pleats.

6. The method of claim 1 wherein the second inflatable portion includes a polymer and the first section is an ablation region.

7. The method of claim 1, wherein the second section has a first width at a first side of the second inflatable portion and a second width at a second side of the second inflatable portion, the first width being greater than the second width.

8. A medical device for treating a bifurcated vessel, the medical device comprising:

a catheter shaft having a proximal region and a distal region and a longitudinal axis;

a first balloon disposed about the distal region of the catheter shaft along the longitudinal shaft; and

a second balloon coupled to the distal region of the catheter shaft and disposed offset from the longitudinal axis, the second balloon having an inflatable region including a plurality of sections, wherein alternating sections have different flexibility and/or stiffness such that one section is more flexible than adjacent sections and/or is stiffer than adjacent sections, wherein the plurality of sections form a pattern of alternating flexibility and/or stiffness;

wherein the pattern of alternating flexibility and/or stiffness in the sections is a pattern of stripes at an oblique angle to the longitudinal axis, wherein the pattern of stripes causes the second balloon to collapse into a predetermined configuration having one or more pleats.

9. The medical device of claim 8, wherein a first section is an ablation region and a second, adjacent section has a higher crystallinity than the first section.

10. The medical device of claim 8, wherein the stripes are at an angle of between about 30 degrees and about 60 degrees from the longitudinal axis.