Removable sheath assembly for a polymer scaffold
First Claim
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1. An apparatus, comprising:
- a catheter having a distal end;
a scaffold crimped to a balloon of the catheter, the scaffold having a length; and
a sheath disposed over the scaffold, the sheath comprising a constraining portion and a protecting portion, the constraining portion comprising a first cylinder, a second cylinder, and a frustum between the first and second cylinders, and the constraining portion is configured to slide over the protecting portion;
wherein the apparatus is configured for being passed through a mammalian body only after the sheath is removed; and
wherein the apparatus is sterilized and contained within a sealed container.
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Abstract
A medical device includes a polymer scaffold crimped to a catheter having an expansion balloon. A sheath is placed over the crimped scaffold after crimping to reduce recoil of the crimped polymer scaffold and maintain scaffold-balloon engagement relied on to hold the scaffold to the balloon when the scaffold is being delivered to a target in a body. The sheath is removed by a health professional either by removing the sheath directly or using a tube containing the catheter.
86 Citations
18 Claims
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1. An apparatus, comprising:
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a catheter having a distal end; a scaffold crimped to a balloon of the catheter, the scaffold having a length; and a sheath disposed over the scaffold, the sheath comprising a constraining portion and a protecting portion, the constraining portion comprising a first cylinder, a second cylinder, and a frustum between the first and second cylinders, and the constraining portion is configured to slide over the protecting portion; wherein the apparatus is configured for being passed through a mammalian body only after the sheath is removed; and wherein the apparatus is sterilized and contained within a sealed container. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
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10. An apparatus, comprising:
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a catheter having a distal end; a balloon-expanded scaffold crimped to a balloon of the catheter; and a sheath disposed over the scaffold and including a constraining sheath and a protecting sheath, wherein both the constraining sheath and the protecting sheath are disposed over an entire length of the scaffold and extend beyond the catheter distal end; wherein the constraining sheath includes a first inner diameter and a second inner diameter, greater than the first inner diameter, and a cylindrical portion forms the second inner diameter; wherein the apparatus is configured for being passed through a mammalian body only after the constraining and protecting sheaths are removed; and wherein the apparatus is sterilized and contained within a sealed container. - View Dependent Claims (11, 12, 13, 14)
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15. An apparatus, comprising:
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a catheter; a scaffold crimped to a balloon of the catheter; a protecting sheath disposed over the scaffold; and a constraining sheath disposed over the protecting sheath, the constraining sheath including a first cylindrical portion configured to apply a radial constraining force on the scaffold, a second cylindrical portion configured to not apply a radial compressive force on the scaffold, and a frustum disposed between the first and second cylindrical portions; wherein both a length of the first cylinder portion and a length of the second cylindrical portion are greater than or about equal to a length of the scaffold; wherein the apparatus is configured for being passed through a mammalian body only after the constraining sheath and the protecting sheath are removed; and wherein the apparatus is sterilized and contained within a sealed container. - View Dependent Claims (16, 17, 18)
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Specification