Thermal processing of polymer scaffolds
Methods are disclosed including thermally processing a scaffold to increase the radial strength of the scaffold when the scaffold is deployed from a crimped state to a deployed state such as a nominal deployment diameter. The thermal processing may further maintain or increase the expansion capability of the scaffold when expanded beyond the nominal diameter.
1. A method of fabricating a scaffold comprising:
providing a scaffold in a fabricated state;
wherein the scaffold has a scaffold pattern including a plurality of undulating rings connected by links and each ring includes crests and bar arms between the crests,
wherein the crests have angles that decrease when the scaffold is crimped and increase when the scaffold is expanded; and
thermally processing the scaffold from the fabricated state to a processed state at a temperature and a time sufficient to decrease an arc length of each ring, the decrease providing a radial strength at a nominal deployment diameter higher than the fabricated state and ductility in the bar arms that allows the rings to stretch to the arc length of the fabricated state without failure when expanded beyond the nominal deployment diameter,
wherein a thickness of the scaffold increases during the thermal processing.
2. The method of claim 1 , further comprising crimping the scaffold from the processed state to a crimped state over a delivery balloon having the nominal deployment diameter.
3. The method of claim 1 , wherein the thermal processing increases the crest angles of the rings.
4. The method of claim 1 , wherein a diameter of the scaffold is fixed during the thermal processing which causes the crest angles to increase as the arc length decreases.
5. The method of claim 4 , further comprising selecting an increase in the angles during the thermal processing and allowing a decrease in diameter of the scaffold that provides the selected increase in angles.
6. The method of claim 1 , further comprising disposing the scaffold over a tubular mandrel prior to the thermal processing, wherein the scaffold diameter decreases to the outer diameter of the mandrel during the thermal processing.
7. The method of claim 1 , wherein the crest angles are less than 100° in the fabricated state and the temperature, time, scaffold diameter decrease, or any combination thereof are selected such that the crest angles are 100° to 150° in the processed state.
8. The method of claim 1 , wherein the thermal processing is performed during a coating process.
9. The method of claim 1 , wherein the fabricated state is an as-cut scaffold.
10. A method of fabricating a scaffold comprising:
providing a scaffold in a fabricated state;
wherein the scaffold has a scaffold pattern including a plurality of undulating rings connected by links and each ring includes crests and bar arms between the crests,
wherein the crests have angles that decrease when the scaffold is crimped and increase when the scaffold is expanded; and
thermally processing the scaffold from the fabricated state to a processed state at a temperature and a time sufficient to decrease an arc length of each ring, the decrease providing a radial strength at a nominal deployment diameter higher than the fabricated state and ductility in the bar arms that allows the rings to stretch to the arc length of the fabricated state without failure when expanded beyond the nominal deployment diameter,
wherein the scaffold is made of a PLA polymer and the temperature is 70 to 90° C. and the time is 5 to 15 min.
11. A method of fabricating a scaffold comprising:
providing a scaffold in a fabricated state;
wherein the scaffold has a scaffold pattern including a plurality of undulating rings connected by links and each ring includes crests and bar arms between the crests,
wherein the crests have angles that decrease when the scaffold is crimped and increase when the scaffold is expanded; and
thermally processing the scaffold from the fabricated state to a processed state at a temperature and a time sufficient to decrease an arc length of each ring, the decrease providing a radial strength at a nominal deployment diameter higher than the fabricated state and ductility in the bar arms that allows the rings to stretch to the arc length of the fabricated state without failure when expanded beyond the nominal deployment diameter,
wherein a thickness of the scaffold is 75 to 100 microns in the fabricated state and increases 10 to 30% during the thermal processing.