Sheaths used with polymer scaffolds
First Claim
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1. An apparatus, comprising:
- a balloon catheter assembly having a distal end and a proximal end, the catheter including a scaffold comprising a polymer crimped to a balloon of the catheter at the catheter distal end;
a sheath disposed over the scaffold, the sheath applying a radially inward force on the crimped scaffold to limit recoil of the scaffold, the sheath comprising;
a protecting portion having a distal end, anda constraining portion having a distal end, wherein the constraining portion distal end is distal of the catheter distal end, andwherein the constraining and protecting portions are configured so that the sheath is capable of being removed from the scaffold by the following steps;
pulling an extension of the constraining portion distally to withdraw the constraining portion from the scaffold, andafter the constraining portion has been displaced distally, continuing to pull the constraining portion distally to remove both the constraining portion and the protecting portion from the scaffold;
wherein the scaffold is crimped by way of plastic deformation of the scaffold to the balloon such that when the sheath is removed the scaffold retains substantially the same diameter it had when disposed within the sheath; and
wherein a balloon material is disposed between struts of the scaffold to contribute to a retention force between the plastically deformed scaffold and a surface of the balloon to resist dislodgment of the scaffold from the balloon after the sheath is removed.
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Abstract
A medical device includes a polymer scaffold crimped to a catheter having an expansion balloon. A sheath pair 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 pair is removed by a health professional before placing the scaffold within the body.
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Citations
12 Claims
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1. An apparatus, comprising:
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a balloon catheter assembly having a distal end and a proximal end, the catheter including a scaffold comprising a polymer crimped to a balloon of the catheter at the catheter distal end; a sheath disposed over the scaffold, the sheath applying a radially inward force on the crimped scaffold to limit recoil of the scaffold, the sheath comprising; a protecting portion having a distal end, and a constraining portion having a distal end, wherein the constraining portion distal end is distal of the catheter distal end, and wherein the constraining and protecting portions are configured so that the sheath is capable of being removed from the scaffold by the following steps; pulling an extension of the constraining portion distally to withdraw the constraining portion from the scaffold, and after the constraining portion has been displaced distally, continuing to pull the constraining portion distally to remove both the constraining portion and the protecting portion from the scaffold; wherein the scaffold is crimped by way of plastic deformation of the scaffold to the balloon such that when the sheath is removed the scaffold retains substantially the same diameter it had when disposed within the sheath; and wherein a balloon material is disposed between struts of the scaffold to contribute to a retention force between the plastically deformed scaffold and a surface of the balloon to resist dislodgment of the scaffold from the balloon after the sheath is removed. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8)
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9. An apparatus, comprising:
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a balloon catheter assembly having a distal end and a proximal end, the catheter including a scaffold comprising a polymer crimped to a balloon of the catheter at the catheter distal end; a unitary sheath disposed over the scaffold, the sheath applying a radially inward force on the crimped scaffold to limit recoil of the scaffold, the sheath comprising; a distal end, and a first and second half configured for being separated from each other when the sheath is being removed from the scaffold by pulling the sheath towards the catheter distal end, and wherein the distal end is distal of the catheter distal end; wherein the scaffold is crimped by way of plastic deformation of the scaffold to the balloon such that when the sheath is removed the scaffold retains substantially the same diameter it had when disposed within the sheath; wherein a balloon material is disposed between struts of the scaffold to contribute to a retention force between the plastically deformed scaffold and a surface of the balloon to resist dislodgment of the scaffold from the balloon after the sheath is removed; and wherein the apparatus is configured into an implantable medical device only after the sheath is removed. - View Dependent Claims (10, 11, 12)
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Specification