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:
- using a catheter including a shaft and a balloon having distal and proximal ends;
crimping a polymer scaffold to the balloon to produce a crimped scaffold;
placing a temporary sheath over the crimped scaffold, the temporary sheath including a flared first end having a continuously increasing diameter, wherein the temporary sheath has a constant inner diameter extending from the flared first end to a second end thereof, and when placed over the crimped scaffold the flared first end is proximal the balloon proximal end and the second end is distal the balloon distal end;
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;
wherein the crimped scaffold is configured for being placed within a body only after the final sheath is removed from 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.
81 Citations
18 Claims
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1. A method for assembling a medical device, comprising:
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using a catheter including a shaft and a balloon having distal and proximal ends; crimping a polymer scaffold to the balloon to produce a crimped scaffold; placing a temporary sheath over the crimped scaffold, the temporary sheath including a flared first end having a continuously increasing diameter, wherein the temporary sheath has a constant inner diameter extending from the flared first end to a second end thereof, and when placed over the crimped scaffold the flared first end is proximal the balloon proximal end and the second end is distal the balloon distal end; 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; wherein the crimped scaffold is configured for being placed within a body only after the final sheath is removed from 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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using a catheter including a shaft and a balloon having distal and proximal ends; crimping a polymer scaffold to the balloon to produce a crimped scaffold; placing a temporary sheath over the crimped scaffold, including deforming a flared end of the temporary sheath to reduce resistance to a sliding of the temporary sheath over 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; wherein the crimped scaffold is configured for being placed within a body only after the final sheath is removed from the crimped scaffold. - View Dependent Claims (11, 12)
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13. A method for making a medical device, comprising:
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using a scaffold formed from a tube comprising poly (L-lactide) and having a first diameter; using a crimp head, crimping the scaffold to a balloon catheter, the scaffold being crimped from the first diameter to a second diameter, the first diameter being at least 2 times the second diameter; holding the scaffold at the second diameter within the crimp head for a dwell period to reduce radial recoil; sliding a first sheath over the crimped scaffold including deforming a flared end of the first sheath as the first sheath slides over the crimped scaffold; and replacing the first sheath with a second sheath; wherein the crimped scaffold is configured for being placed within a body only after the second sheath is removed from the crimped scaffold. - View Dependent Claims (14, 15, 16, 17, 18)
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Specification