Prosthesis adapted for placement under external imaging

• US 8,157,810 B2
• Filed: 02/26/2004
• Issued: 04/17/2012
• Est. Priority Date: 02/26/2003
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Case, Brian C., Flagle, Jacob A., Garrison, Michael L., Hoffa, Andrew K., Leonard, Ray II
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): Stroud, Jonathan R
• Application Number:
  US10/787,307
• Publication Number:
  US 20040167619A1
• Time in Patent Office: 2,973 Days
• Field of Search: 623/1.38
• US Class Current: 606/108
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2230/0026 trapezoidal
• CPC Class Codes: A61F 2230/0095 Saddle-shaped
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

A expandable prosthesis having an imageable structure comprising one or more elements visually distinguishable by an external (e.g., radiographic or ultrasonic) imaging system, the structure being located about a first axis that corresponds to a structural feature of the prosthesis that is configured to perform a specific function particular to that axis. The imageable structure is configured to assist in the rotational orientation of the prosthesis during placement within the implantation site. In one embodiment, the prosthesis comprises a venous valve that includes imageable elements or structure, such as a pair of radiopaque markers, that defines the orifice of the valve structure such that the orifice can be oriented with a particular anatomical feature under imaging, such as to align the orifice with the long axis of the vessel. In another embodiment, the imageable structure is configured to permit an aperture located about a stent graft to be oriented with a anatomical feature of the vessel, such as a branch vessel opening. The invention includes a method for using imageable structure to confirm that the orientation of the prosthesis within a delivery apparatus is consistent the desired delivery approach to be used.

Claims

1. 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.

2. The method of claim 1, wherein each of the first and second imageable elements comprises a radiopaque material.

3. The method of claim 1, wherein each of the first and second imageable elements comprises an ultrasonically reflective surface.

4. The method of claim 1, wherein at least one of the first and second imageable elements defines a first shape when viewed in a first profile and a second shape when viewed in a second profile different from the first profile, each of the first and second shapes being configured such that they are indicative of a particular orientation of the orifice to a viewer while under radiographic observation.

5. The method of claim 1, wherein the leaflet structure is attached to a support structure.

6. The method of claim 5, wherein each of the first and second imageable elements is attached to the support structure.

7. The method of claim 5, wherein each of the first and second imageable elements comprises a cannula attached to the support structure.

8. The method of claim 5, wherein each of the first and second imageable elements comprises a layer of material disposed on the support structure.

9. The method of claim 5, wherein the support structure comprises a plurality of struts, and wherein each of the first and second imageable elements comprises one or more struts of the plurality of struts configured to comprise a radiographic profile that is visually distinct from other struts of the plurality of struts.

10. The method of claim 5, wherein the valve prosthesis further comprises a covering material attached to the support structure and enclosing one of the first and second imageable elements.

11. The method of claim 5, wherein the support structure comprises a frame having first and second coiled bends and wherein each of the first and second imageable elements comprises a radiopaque element disposed within one of the first and second coiled bends.