Methods to increase fracture resistance of a drug-eluting medical device
First Claim
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1. A method for making a medical device, comprising:
- using a scaffold comprising a polymer; and
using a crimping device, crimping the scaffold from a first diameter to a second diameter by plastic deformation of the scaffold whereinduring the crimping the scaffold has an elevated temperature of between 5 to 20 degrees below a glass transition temperature of the polymer,the scaffold is crimped to a balloon having a deployed diameter that is between 2 to 5 times the second diameter,the scaffold has a closed cell pattern formed by rings, wherein a ring comprises a first strut and a second strut adjoined at a hinge element, andthe first strut displaces more than 130 degrees relative to the second strut when the scaffold is crimped from the first diameter to the second diameter.
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Abstract
Methods for increasing the fracture resistance of a polymer stent'"'"'s drug-polymer coating and scaffolding including applying a coating and crimping using techniques that increase the resistance to fracture in the coating layer and scaffolding and scaffolding.
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Citations
15 Claims
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1. A method for making a medical device, comprising:
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using a scaffold comprising a polymer; and using a crimping device, crimping the scaffold from a first diameter to a second diameter by plastic deformation of the scaffold wherein during the crimping the scaffold has an elevated temperature of between 5 to 20 degrees below a glass transition temperature of the polymer, the scaffold is crimped to a balloon having a deployed diameter that is between 2 to 5 times the second diameter, the scaffold has a closed cell pattern formed by rings, wherein a ring comprises a first strut and a second strut adjoined at a hinge element, and the first strut displaces more than 130 degrees relative to the second strut when the scaffold is crimped from the first diameter to the second diameter. - View Dependent Claims (2, 3, 4, 5, 6, 7)
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8. A method for making a balloon-expanded medical device having increased fracture resistance, comprising:
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using a scaffold comprising a polymer including a closed cell pattern formed by a pair of adjacent rings, each ring comprising a first strut and a second strut adjoined at a hinge element, the scaffold having a pre-crimp diameter; depositing a coating on a surface of the scaffold including repeating the steps of depositing a drug-polymer mixed with a solvent in an amount of between about 90-98% by weight solvent until a final coating weight is reached; and crimping the scaffold to a balloon and a final crimp diameter while the scaffold has an elevated temperature of between 5 to 20 degrees below a glass transition temperature of the polymer, wherein the first strut rotates through an angle of more than 130 degrees relative to the second strut when the scaffold is crimped to the final crimp diameter. - View Dependent Claims (9, 10, 11, 12, 13)
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14. A method for making a medical device, comprising:
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using a scaffold comprising a polymer; and using a crimping device, crimping the scaffold from a first diameter to a second diameter by plastic deformation of the scaffold, the crimping including at least a first and second diameter reduction of the scaffold, wherein during the crimping the scaffold has an elevated temperature of between 5 to 20 degrees below a glass transition temperature of the polymer, the scaffold first diameter is greater than a deployed diameter for the balloon, the scaffold has a closed cell pattern formed by a pair of adjacent rings comprising first and second struts adjoined at a hinge element, and a pair of links connecting the rings, and the first strut displaces more than 130 degrees relative to the second strut when the scaffold is crimped from the first diameter to the second diameter. - View Dependent Claims (15)
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Specification