BALLOON BIFURCATED LUMEN TREATMENT

• US 20100114018A1
• Filed: 06/05/2009
• Published: 05/06/2010
• Est. Priority Date: 11/14/2007
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: XIONG, YING, QUILLIN, DAN, GOODIN, RICHARD, HORN, DANIEL J., TEGELS, ZACH, NODDIN, RICHARD, TRAN, THE THOMAS TRINH, ALKHATIB, YOUSEF F., HOFF, STEVE, HOLMAN, THOMAS, DUNN, RICHARD
• Granted Patent: US 8,936,567 B2
• Time in Patent Office: Days
• US Class Current: 604/101.10
• 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 2250/0036 differing in thickness
• CPC Class Codes: A61M 25/1027 Making of balloon catheters

Abstract

Balloon systems for treating bifurcated lumens include desirable burst and folding characteristics. In some cases, the balloon systems can be formed by varying the wall thickness of a balloon parison.

Claims

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

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

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

a second balloon coupled to the distal region of the catheter shaft and disposed offset from the axis, the second balloon having an expandable region configured to expand in a direction at an angle from the axis, the second balloon having a base region opposite the expandable region, wherein the wall thickness of the base region is greater than the wall thickness of the expandable region.

2. The medical device of claim 1 wherein the expandable region includes an apex and one or more sides, wherein the wall thickness of the one or more side regions are greater than the wall thickness of the apex.

3. The medical device of claim 2 wherein the second balloon includes one or more predefined burst regions in which wall thickness is reduced relative to adjacent regions.

4. The medical device of claim 3 wherein the predefined burst region is in the base region.

5. The medical device of claim 3 wherein the predefined burst region is in the one or more side regions.

6. The medical device of claim 1 wherein the second balloon includes a predefined folding region having increased flexibility relative to other regions of the second balloon.

7. The medical device of claim 6 wherein the folding region is a localized zone of reduced wall thickness or increased crystallinity.

8. The medical device of claim 1 wherein the second balloon includes a predefined folding region having an electroactive polymer.

9. The medical device of claim 1 further comprising a stent disposed about a portion of the first balloon and a portion of the second balloon.

10. A medical device for treating a bifurcated lumen, the medical device comprising:

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

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

a second balloon coupled to the distal region of the catheter shaft and disposed offset from the axis, the second balloon having an expandable region configured to expand in a direction at an angle from the axis, the second balloon having a base region opposite the expandable region, wherein the second balloon includes a predefined burst region.

11. The medical device of claim 10 wherein the predefined burst region is a localized region of reduced wall thickness.

12. The medical device of claim 11 wherein the predefined burst region is in the base region.

13. The medical device of claim 11 wherein the expandable region includes an apex and one or more sides, wherein the predefined burst region is in the one or more sides.

14. A medical device for treating a bifurcated lumen, the medical device comprising:

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

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

a second balloon coupled to the distal region of the catheter shaft and disposed offset from the axis, the second balloon having an expandable region configured to expand in a direction at an angle from the axis, the second balloon having a base region opposite the expandable region, wherein the balloon has a predefined fold region in the base region and/or expandable region.

15. A medical device for treating a bifurcated lumen, the medical device comprising:

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

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

a second balloon coupled to the distal region of the catheter shaft and disposed offset from the axis, the second balloon having an expandable region configured to expand at an angle from the axis, the second balloon having a base region opposite the expandable region, wherein the first balloon and second balloon are concentrically disposed about the catheter shaft.

16. A medical device for treating a bifurcated lumen, the medical device comprising:

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

a balloon coupled to the distal region of the catheter shaft, wherein the balloon includes an electroactive polymer, wherein an exposure to an electrical current causes the electroactive polymer to expand such that the balloon folds into lobes.

17. A method of forming a balloon for treating a bifurcated lumen, the method comprising:

providing a tubular parison defining an axis and having a variable wall thickness region;

utilizing the variable wall thickness region of the parison to form a balloon inflatable off the axis; and

expanding the parison to form the balloon such that a first region of the parison having a greater thickness is expanded to a greater extent than a second region of the parison having a lesser thickness.

18. The method of claim 17 further comprising:

forming the balloon by expanding the parison in a mold shaped to correspond to a balloon inflatable off axis; and

orienting the parison in the mold such that a first region of the parison having a greater wall thickness is expanded to a greater extent than a second region of the parison having a lesser thickness.

19. The method of claim 17 further comprising forming a predefined burst region in the balloon, wherein the predefined burst region is a localized zone in which the balloon wall thickness is reduced.

20. The method of claim 17 further comprising forming a predefined folding region in the balloon, wherein the preferential folding region is a zone of increased flexibility.