Reducing Recoil in Peripherally-Implanted Scaffolds
AssigneeAbbott Cardiovascular Systems Inc.
InventorsMichael Huy Ngo, Benjamyn Serna, Mikael Trollsas, Syed Hossainy
Life of this patent
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Abstract
A peripherally implanted polymer scaffold having a high degree of recoil is worked to reduce recoil in the scaffold when initially deployed at a target lesion in the body. The scaffold is plastically deformed from a crimped state to an expanded state by a balloon catheter. The scaffold is contained within a sheath to prevent recoil up until the point of use. Before the scaffold is introduced to the body, the restraining sheath is removed from the scaffold.
Claims25
A method for reducing recoil of a polymeric scaffold at a site in a peripheral vessel of the body, comprising the steps of:
- using a balloon disposed within the scaffold, inflating the balloon whereby the scaffold attains an expanded diameter;
- and
- after the scaffold has the expanded diameter, applying balloon pressure to the scaffold for more than two minutes.
A method for implanting a polymeric scaffold in a peripheral vessel, comprising the steps of:
- removing a restraining sheath from a scaffold, the scaffold being crimped to a balloon of a catheter and the sheath being used to reduce recoil of the scaffold;
- after removing the sheath, introducing the scaffold into a peripheral vessel of the body including placing the scaffold at a target site of the peripheral vessel;
- inflating the balloon when the scaffold is located at the target site, whereby the scaffold attains an expanded diameter;
- and
- after the scaffold has the expanded diameter, applying balloon pressure to the scaffold to reduce recoil.
A method for reducing the recoil of an implanted polymer scaffold, the scaffold being located at a target site in a peripheral vessel, the scaffold being crimped to a balloon of a catheter, comprising the steps of:
- inflating the balloon to expand the scaffold to an expanded diameter;
- holding the balloon in an inflated state for greater than two minutes, between 5 and 10 minutes, 5 minutes or 10 minutes;
- deflating the balloon;
- and
- inflating the balloon a second time to reduce the recoil in the implanted polymer scaffold to less than 10% of the expanded diameter.
A kit, comprising:
- a scaffold-catheter system comprising a scaffold crimped to a balloon, the scaffold-catheter system being adapted for use in a medical procedure whereby the scaffold is delivered to a target site in a peripheral vessel of the body and deployed using the balloon catheter;
- a package containing the scaffold-catheter system;
- an indicia disposed on or in the package indicating a date when the scaffold-catheter system was made;
- and
- instructions for use (IFU) that indicate a first step or a second step that should be followed to reduce recoil in the scaffold depending on the date when the scaffold-catheter system was made.
Dependencies are inferred from the claim text.