Balloon catheter with spiral folds
First Claim
Patent Images
1. A balloon catheter having a spirally folded balloon comprising:
- a catheter body having a proximal end and a distal end; and
a radially expansible balloon near the distal end of the catheter body, the balloon comprising a proximal end, a distal end, and at least one permanent fold line formed on the balloon prior to folding, the fold line extending helically along at least a portion of the surface of the balloon.
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Abstract
The balloon catheter comprises a radially expansible, polymeric balloon having one or more permanent helical fold lines so that the balloon can be spirally folded upon delivery of the catheter to or removal from a vessel. A scoring structure may be carried over the balloon in between the folds to score a stenosed region in a blood vessel. Fabrication devices and methods for spirally folding the balloon are also disclosed.
227 Citations
73 Claims
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1. A balloon catheter having a spirally folded balloon comprising:
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a catheter body having a proximal end and a distal end; and
a radially expansible balloon near the distal end of the catheter body, the balloon comprising a proximal end, a distal end, and at least one permanent fold line formed on the balloon prior to folding, the fold line extending helically along at least a portion of the surface of the balloon. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14)
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15. A balloon catheter comprising:
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a catheter body having a proximal end and a distal end; and
a radially expansible balloon near the distal end of the catheter body, the balloon comprising a proximal end, a distal end, and at least one recess extending helically along at least a portion of the surface of the balloon; and
at least one helical scoring structure located within the helical recess of the balloon, wherein the helical recess shields the scoring structure from exposure when the balloon is not expanded. - View Dependent Claims (16, 17, 18, 19, 20)
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21. A method of folding a balloon on a balloon catheter for insertion in a body lumen, the method comprising:
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providing a balloon having at least one fold line formed in a wall of the balloon and extending helically along the outer surface of the balloon; and
folding the balloon along the at least one helical fold line. - View Dependent Claims (22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53)
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54. A method of treating a body lumen of a patient, the method comprising:
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providing a catheter having a balloon with at least one fold line formed in the wall of the balloon and extending helically along the outer surface of the balloon, inserting the catheter in its helically-folded state into the body lumen;
advancing the catheter to a treatment site within the lumen; and
inflating the balloon to engage a wall of the lumen to treat the lumen. - View Dependent Claims (55)
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56. A device for fabricating a radially expansible balloon for a balloon catheter, the balloon having at least one helical fold, the device comprising:
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a base, a mounting fixture connected to the base, the mounting fixture adapted to receive the balloon;
means for advancing the balloon relative to the mounting fixture; and
at least one scoring element mounted to the mounting fixture, wherein the number of scoring elements corresponds to the number of helical folds to be fabricated; and
wherein the at least one scoring element converges on the balloon as it is advanced so that the scoring element creates at least one score extending helically along the outer surface of the balloon, the helical score allowing the balloon to be helically folded along the score. - View Dependent Claims (57, 58, 59, 60, 61, 62, 63, 64)
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65. A device for fabricating a radially expansible balloon for a balloon catheter, the balloon having at least one helical fold, the device comprising:
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a plurality of helical plates placed adjacent to each other to form at least one helical gap;
a support for the holding the helical plates together, the collar being adjustable to permit the size of the at least one helical gap to be modified; and
means for applying pressure to press the helical plates together, wherein a portion of the balloon may be inserted between the helical plates and pressed to form at least one fold line extending helically along an outer surface of the balloon, and wherein the balloon may be spirally folded along the fold line. - View Dependent Claims (66, 67)
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68. A device for fabricating a radially expansible balloon for a balloon catheter, the balloon having at least one helical fold, the device comprising:
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an expansible cage having at least one helical segment, wherein the number of helical segments corresponds to the number of helical fold lines to be fabricated; and
a heat source coupled to the cage;
wherein the heat source heats the cage to create the at least one helical fold line. - View Dependent Claims (69, 70, 71, 72, 73)
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Specification