Processes for making crush recoverable polymer scaffolds
First Claim
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1. A method for making a medical device, comprising:
- forming a scaffold from a tube made from a polymer having a glass transition temperature (Tg);
crimping the scaffold to a balloon at a crimping temperature between about 1 to 20 degrees less than Tg, wherein the scaffold is plastically deformed to have a crimped state; and
fitting a removable sheath over the scaffold and balloon following crimping to limit recoil of the crimped scaffold;
wherein the scaffold has an expanded diameter when plastically deformed from the crimped state by the balloon; and
wherein the scaffold attains greater than 90% of the expanded diameter after being crushed by an amount equal to at least 33% of the expanded diameter.
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Abstract
Methods for making scaffolds for delivery via a balloon catheter are described. The scaffold, after being deployed by the balloon, provides a crush recovery of about 90% after the diameter of the scaffold has been pinched or crushed by 50%. The scaffold structure has patterns that include an asymmetric or symmetric closed cell, and links connecting such closed cells.
35 Citations
19 Claims
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1. A method for making a medical device, comprising:
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forming a scaffold from a tube made from a polymer having a glass transition temperature (Tg); crimping the scaffold to a balloon at a crimping temperature between about 1 to 20 degrees less than Tg, wherein the scaffold is plastically deformed to have a crimped state; and fitting a removable sheath over the scaffold and balloon following crimping to limit recoil of the crimped scaffold; wherein the scaffold has an expanded diameter when plastically deformed from the crimped state by the balloon; and wherein the scaffold attains greater than 90% of the expanded diameter after being crushed by an amount equal to at least 33% of the expanded diameter. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8)
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9. A method for making a medical device, comprising:
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forming a tube from a polymer, the tube having a tube diameter and a wall thickness such that a ratio of the tube diameter to the wall thickness is between 30 and 60 or between 20 and 45; forming a scaffold from the tube, the scaffold having a diameter, wherein the scaffold is capable of regaining more than 90% of the scaffold diameter after being crushed by an amount equal to at least 33% the scaffold diameter; and crimping the scaffold to a balloon, including the step of using a crimping temperature between 1 and 20 degrees less than a glass transition temperature of the polymer. - View Dependent Claims (10, 11, 12, 13)
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14. A method for making a medical device, comprising:
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forming a polymer tube having a tube diameter and a wall thickness such that a ratio of the tube diameter to the wall thickness is between 30 and 60 or between 20 and 45; and forming a scaffold from the tube, the scaffold having a diameter; wherein the scaffold is capable of regaining more than 90% of the scaffold diameter after being crushed by an amount equal to at least 33% the scaffold diameter; wherein the scaffold exhibits the more than 90% of the expanded diameter when crushed to the at least 33% of the expanded diameter using a pair of opposed flat metal plates and while the scaffold has a temperature of 20 degrees Celsius, and the scaffold diameter is measured after a crush period of about 0 seconds, 1 minute or 5 minutes. - View Dependent Claims (15, 16, 17, 18, 19)
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Specification