Patent ID: 8157810

Claim:
A method of verifying the orientation of a valve prosthesis within a delivery apparatus prior to introduction into a peripheral vessel of a patient, the valve prosthesis adapted for placement in the peripheral vessel, the valve prosthesis and delivery apparatus associated with packaging material, the method comprising the steps of: providing the valve prosthesis loaded within the delivery apparatus, the delivery apparatus having a proximal end and a distal end adapted for insertion into a body vessel of a patient, and the valve prosthesis having first and second ends, a leaflet structure defining an orifice at the first end and extending from the orifice toward the second end such that the leaflet structure is configured to catch retrograde blood flow, and an imageable structure comprising first and second imageable elements located about the orifice, the valve prosthesis adapted for placement in said peripheral vessel of said patient; imaging the delivery apparatus and the valve prosthesis prior to introduction into said peripheral vessel of said patient using an external imaging system to determine a location of the imageable structure relative to the distal end of the delivery apparatus; determining the orientation of the valve prosthesis within the delivery apparatus relative to the distal end of the delivery apparatus using the determined location of the imageable structure; and verifying that the determined orientation of the valve prosthesis is indicative of a delivery approach specified by indicia located on at least one of the delivery apparatus and the packaging material; wherein a determined orientation in which the orifice of the valve prosthesis is located closest to the distal end of the delivery apparatus such that the leaflet structure extends away from the orifice and away from the distal end of the delivery device is indicative of an ascending delivery approach, and wherein a determined orientation in which the second end of the valve prosthesis is located closest to the distal end of the delivery apparatus such that the leaflet structure extends away from the orifice and toward the distal end of the delivery device is indicative of a descending delivery approach.