Sheaths reducing recoil and loss of retention for polymer scaffolds crimped to balloons
First Claim
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1. A method for assembling a medical device, comprising:
- providing a catheter including a shaft and a balloon having distal and proximal ends;
disposing a temporary sheath on the catheter shaft;
crimping a polymer scaffold to the balloon while the sheath is disposed on the catheter shaft;
advancing the temporary sheath from the balloon proximal end towards the balloon distal end to radially constrain the crimped scaffold;
inspecting the crimped scaffold and/or balloon within the temporary sheath;
removing the temporary sheath from the crimped scaffold; and
placing a final sheath over the crimped scaffold.
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Abstract
A medical device includes a polymer scaffold crimped to a catheter having an expansion balloon. A single piece sheath is placed over the scaffold immediately following crimping of the scaffold to the balloon. The single piece sheath is replaced by a two-piece sheath, which is removed prior to performing a medical procedure using the medical device.
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Citations
23 Claims
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1. A method for assembling a medical device, comprising:
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providing a catheter including a shaft and a balloon having distal and proximal ends; disposing a temporary sheath on the catheter shaft; crimping a polymer scaffold to the balloon while the sheath is disposed on the catheter shaft; advancing the temporary sheath from the balloon proximal end towards the balloon distal end to radially constrain the crimped scaffold; inspecting the crimped scaffold and/or balloon within the temporary sheath; removing the temporary sheath from the crimped scaffold; and placing a final sheath over the crimped scaffold. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
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10. A method for assembling a medical device, comprising:
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providing a catheter including a polymer scaffold crimped to a balloon; and constraining the scaffold including placing a first sheath over the scaffold; removing the first sheath from the scaffold; and after removal of the first sheath, placing a second sheath over the scaffold; wherein the first sheath is placed by restraining the catheter shaft while the first sheath is pulled towards a balloon distal end; and wherein the pulling step includes depressing a flared end of the first sheath so as to avoid shifting of balloon material while the first sheath is being placed over the scaffold. - View Dependent Claims (11, 12, 13, 14, 15)
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16. A method for assembling a medical device, comprising:
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providing a balloon catheter, a scaffold and a sheath disposed on a shaft of the balloon catheter between a catheter proximal end and a balloon proximal end; crimping the scaffold to the balloon-catheter; positioning the sheath over the scaffold including moving a distal end of the sheath towards a balloon distal end, wherein the sheath is a first sheath made from a semi-transparent material, further including the steps of; inspecting the scaffold and balloon within the first sheath, after inspecting the scaffold, removing the first sheath from the scaffold, then placing a second sheath over the scaffold to minimize recoil of the scaffold, wherein the medical device is configured for being passed through a body only after the second sheath is removed from the scaffold. - View Dependent Claims (17, 18, 19, 20, 21, 22)
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23. A method for making a medical device, comprising:
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providing a scaffold formed from a radially-expanded tube and having a pre-crimp diameter, the radially-expanded tube comprising a polymer; crimping the scaffold to a balloon catheter, the scaffold being crimped from the pre-crimp diameter to a final diameter, the pre-crimp diameter being at least 2 times the final diameter; placing the crimped scaffold within a first sheath by pulling the first sheath towards a distal end of the balloon catheter so that the crimped scaffold is disposed within the first sheath, the first sheath having a first diameter and a first radial stiffness sufficient to restrain recoil of the scaffold after crimping; replacing the first sheath with a second sheath having a second diameter and a second radial stiffness, the second sheath capable of being removed from the crimped scaffold by a medical professional; wherein the crimped scaffold is configured for being placed within a body only after the second sheath is removed from the crimped scaffold; and wherein the first diameter is less than the second diameter and/or the first radial stiffness is greater than the second radial stiffness.
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Specification