Post-Crimping Inspection of Scaffolds Mounted on Scaffold Delivery Systems
AssigneeAbbott Cardiovascular Systems Inc.
InventorJason Van Sciver
Life of this patent
Estimating the term…
Abstract
A system for mounting a scaffold on a balloon catheter includes two positioning and alignment stations, which are used to prepare a scaffold and catheter for crimping using the same crimping head. The system is configured for automated assembly of the scaffold and catheter prior to crimping and performing post-crimping inspection for the crimped scaffold and prior to placing a restraining sheath over the crimped scaffold.
Claims24
A method for crimping a scaffold to a balloon catheter, comprising:
- connecting the scaffold and balloon catheter to a member including an actuator capable of inserting a distal end of the catheter into and removing the distal end from a crimper head, the crimper head configured for crimping the scaffold to the balloon;
- inserting the balloon and scaffold into the crimper head using the actuator;
- crimping the scaffold to the balloon to produce a crimped scaffold;
- removing the crimped scaffold from the crimper head using the actuator;
- collecting images of the crimped scaffold and balloon using the actuator;
- and
- after collecting images, placing a restraining sheath over the crimped scaffold.
A method of crimping a scaffold to a balloon of a balloon catheter, comprising placing the scaffold in a receptacle,
- engaging the catheter by an actuator;
- inserting the balloon at least partially within the scaffold using the actuator;
- positioning the scaffold on the balloon by either of pulling a distal end of the balloon towards a distal end of the scaffold, or pushing the distal end of the scaffold towards the distal end of the balloon using the actuator;
- and
- crimping the scaffold to the balloon.
An apparatus for mounting a scaffold to a balloon catheter, comprising:
- a crimper head having jaws and configured to crimp the scaffold to a balloon of the balloon catheter;
- an actuator including a motor capable of rotating a distal end of the balloon catheter about a longitudinal axis and inserting the distal end into and removing the distal end from the crimper head;
- an imaging device;
- a processor;
- and
- machine executable code, executable by the processor, for performing a mounting process, the machine executable code including a first code for causing the actuator to translate and/or rotate about the longitudinal axis;
- a second code for crimping the scaffold to the balloon using the crimper head;
- and
- a third code for collecting images of the crimped scaffold.
A method for evaluating a crimping process, comprising:
- providing a crimping apparatus including a crimper head and an automated control actuator capable of placing a scaffold and a balloon of a balloon catheter into and removing the scaffold and the balloon from a crimper head;
- crimping a first plurality of scaffolds to balloons using a first crimping process parameter including generating images of each of the first crimped scaffolds;
- crimping a second plurality of scaffolds to balloons using a second process parameter including generating images of each of the second crimped scaffolds;
- comparing images of the first and second plurality of crimped scaffolds including generating a number indicating whether a difference between the first or second process parameter and a difference between the first and second plurality of crimped scaffolds is statistically significant.
Dependencies are inferred from the claim text.