Asymmetric dilatation balloon

• US 6,129,737 A
• Filed: 10/07/1996
• Issued: 10/10/2000
• Est. Priority Date: 03/01/1994
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Corporation
• Inventors: Kalashian, Daniel J., Vafiades, David B., Mandenjian, Arthur R., Barry, Ralph J., Hamilton, Bruce S.
• Primary Examiner(s): McDermott, Corrine
• Application Number:
  US08/726,548
• Time in Patent Office: 1,464 Days
• Field of Search: 604/96-99, 604/101, 604/104, 604/916, 606/191, 606/192, 606/194, 606/198
• US Class Current: 606/194
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence

Abstract

Dilating an obstructed region in a narrow, highly torturous lumen with a dilatation catheter having near its distal end an inflatable balloon with a dilatation section, a proximal taper section, and distal taper section. The dilatation section is generally cylindrical in shape when the balloon is inflated. The distal taper section has a relatively abrupt slope, and the proximal taper section has a relatively gradual slope.

Claims

1. A method of angioplasty in which a stenosis in a blood vessel is dilated, comprising:

providing a guidewire, and a dilatation catheter that is constructed for positioning in said blood vessel by sliding said catheter over said guidewire, said catheter having a flexible catheter body defining an axis and having a proximal end and a distal end, and near the distal end, said catheter body carrying an angioplasty balloon formed of a nondistendable polymer, said catheter body having a length of about 75-150 cm and defining a first lumen and a second lumen, said first lumen extending through said balloon and sized to slideably receive said guidewire, and said second lumen extending from the proximal end and including a port open to the interior of the balloon for introducing inflation fluid to inflate said balloon,

the balloon including a dilatation section, a proximal taper section, and a distal taper section,

said dilatation section extending substantially parallel to the axis of the catheter when the balloon is in the inflated state end over a sufficient length for engaging and dilating the stenosis by forcing the stenosis open under dilatation pressure,

said proximal taper section having a gradual proximal slope to the catheter for providing a gradual, atraumatic profile upon withdrawal of said catheter from the blood vessel after dilatation, and

said distal taper section having an abrupt distal slope extending a short length compared to said proximal taper section,

placing said catheter into said blood vessel with said balloon in the deflated state and wrapped about said catheter to present a small diameter profile,

positioning said catheter by sliding said catheter over a guidewire so that said dilatation section of said balloon is adjacent said stenosis,

inflating said balloon while the balloon is within the stenosis to engage said dilatation section with said stenosis and to dilate said senosis by radial force applied by said dilatation section,

deflating said balloon, and

withdrawing said catheter body.

2. The method of claim 1 wherein said proximal taper section has a transition taper angle of about 3-15°

and said distal taper section has a transition taper angle of about 10-35°

.

3. The method of claim 2 wherein said proximal taper section has a transition taper angle of about 10°

and said distal taper section has a transition taper angle of about 20°

.

4. The method of claim 2 wherein said distal and proximal taper sections have differing transition taper angles selected to maintain a balloon volume that is in the range equal to or less than the volume of a balloon having the same dilatation section length and inflation diameter and proximal and distal taper sections of a matching transition taper angle between 8-12°

.

5. The method of claim 1 wherein said balloon is composed of polymer including polyethyleneterephthalate.

6. The method of claim 1 wherein the proximal taper section has a transition taper angle of about 3 to 15°

.

7. The method of claim 1 wherein the axial length of the dilatation section is greater than the axial length of the distal taper section or the proximal taper section.

8. The method of claim 1 wherein the axial length of the dilatation section is equal to or greater than the length of the proximal taper section.

9. The method of claim 1 wherein the axial length of the dilatation section is twice the length of the proximal taper section or greater.

10. The method of claim 1 wherein the axial length of the dilatation section is greater than the combined length of the proximal and distal taper sections.

11. A vascular dilatation catheter that is constructed for positioning in a blood vessel by sliding said catheter over a guidewire in an angioplasty operation in which a stenosis is dilated, comprising:

a flexible catheter body defining a device axis and having a proximal end and a distal end and, near the distal end, said catheter body carrying an angioplasty balloon formed of nondistendable polymer, said catheter body having a length of about 75-150 cm and defining a first and second lumen, said first lumen sized to slideably receive a guidewire for delivery of said catheter over a guidewire through said vessel to the stenosis, and said second lumen extending from the proximal end and including a port open to the interior of the balloon for introducing inflation fluid from the proximal end of said catheter to inflate said balloon,

the balloon including a dilatation section, a proximal taper section, and a distal taier section,

said dilatation section extending substantially parallel to the axis of the catheter when the balloon is in the inflated state and over a sufficient length for engaging and dilating the stenosis by forcing the stenosis open under dilatation pressure, wherein the length of the dilatation section is greater than the length of the distal taper section or the proximal taper section,

said proximal taper section having a gradual proximal slone to the catheter for providing a aradual, atraumatic profile upon withdrawal of said catheter from the blood vessel after dilatation, and

said distal taper section having an abruis distal slope extending a short length compared to said proximal taper section.

14. The catheter of any one of claims 11-13 wherein said proximal taper section has a transition taper angle of about 3-15°

and a distal taper section has a transition taper angle of about 10-35°

.

15. The catheter of claim 14 wherein said proximal taper section has a transition taper angle of about 10°

and said distal taper section has a transition taper angle of about 20°

.

16. The catheter of claim 14 wherein said distal and proximal taper sections have differing transition taper angles selected to maintain a balloon volume that is in the range equal to or less than thevolume of a balloon having the same dilatation section length and inflation diameter and proximal and distal taper sections of a matching transition taper angle between 8-12°

.

17. The catheter of any one of claims 11-13 wherein said balloon is composed of polymer including polyethyleneterephthalate.

18. The catheter of any one of claims 11-13 wherein the proximal taper section has a transition taper angle of about 3 to 15°

.

19. The catheter of any one of claims 11-13 wherein said angioplasty balloon is a multilayer balloon.

20. The catheter of claim 19 wherein said angioplasty balloon includes an inner layer of polyethyleneterephthalate.

21. The catheter of claim 19 wherein said angioplasty balloon includes an outerlayer of elastomer.

12. A vascular dilatation catheter that is constructed for positioning in a blood vessel by sliding said catheter over a guidewire in an angioplasty operation in which a stenosis is dilated, comprising:

a flexible catheter body defining a device axis and having a proximal end and a distal end and, near the distal end, said catheter body carrying an angioplasty balloon formed of nondistendable polymer, said catheter body having a length of about 75-150 cm and defining a first and second lumen, said first lumen sized to slideably receive a guidewire for delivery of said catheter over a guidewire through said vessel to the stenosis, and said second lumen extending from the proximal end and including a port open to the interior of the balloon for introducing inflation fluid from the proximal end of said catheter to inflate said balloon,

the balloon including a dilatation section, a proximal taper section, and a distal taper section,

said dilatation section extending substantially parallel to the axis of the catheter when the balloon is in the inflated state and over a sufficient length for engaging and dilating the stenosis by forcing the stenosis open under dilatation pressure, wherein the length of the dilatation section is equal to or greater than the length of the proximal taper section,

said proximal taper section having a gradual proximal slope to the catheter for providing a gradual, atraumatic profile upon withdrawal of said catheter from the blood vessel after dilatation, and

said distal taper section having an abrupt distal slope extending a short length compared to said proximal taper section.

13. A vascular dilatation catheter that is constructed for positioning in a blood vessel by sliding said catheter over a guidewire in an angioplasty operation in which a stenosis is dilated, comprising:

a flexible catheter body defining a device axis and having a proximal end and a distal end and, near the distal end, said catheter body carrying an angioplasty balloon formed of nondistendable polymer, said catheter body having a length of about 75-150 cm and defining a first and second lumen, said first lumen sized to slideably receive a guidewire for delivery of said catheter over a guidewire through said vessel to the stenosis, and said second lumen extending from the proximal end and including a port open to the interior of the balloon for introducing inflation fluid from the proximal end of said catheter to inflate said balloon,

the balloon including a dilatation section, proximal taper section, and a distal taper section,

said dilatation section extending substantially parallel to the axis of the catheter when the balloon is in the inflated state and over a sufficient length for engaging and dilating the stenosis by forcing the stenosis open under dilatation pressure, wherein the length of the dilatation section is greater than the combined length of the proximal and distal taper sections,

said proximal taper section having a gradual proximal slope to the catheter for providing a gradual, atraumatic profile upon withdrawal of said catheter from the blood vessel after dilatation, and

said distal taper section having an abrupt distal slope extending a short length compared to said proximal taper section.