Covered endoprosthesis and delivery system

• US 7,056,336 B2
• Filed: 06/21/2002
• Issued: 06/06/2006
• Est. Priority Date: 01/22/1999
• Status: Expired due to Term

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: Gore Enterprise Holdings Incorporated
• Inventors: Cully, Edward H., Armstrong, Joseph R., Vonesh, Michael J., Gallegos, Margaret L.
• Primary Examiner(s): BUI, VY Q
• Application Number:
  US10/176,929
• Publication Number:
  US 20020198588A1
• Time in Patent Office: 1,446 Days
• Field of Search: 623 111- 122, 623 123- 154, 606191-195, 606/198
• US Class Current: 623/1.13
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/844 folded prior to deployment
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2230/0054 V-shaped

Abstract

The present invention is an improved endovascular device particularly useful for use in transjugular intrahepatic portosystemic shunt (TIPS) procedures. The device employs a two-part stent-graft construction that provides a low permeability membrane to line the shunt and an uncovered stent portion designed to reside in the portal vein. The device provides numerous benefits over previous stents and stent-grafts used in TIPS procedures, including being more compact to deliver, being easier to accurately deploy, a controlled compacted surface with tucked apices, an improved stent winding pattern, and being more flexible in delivery and use.

Claims

1. An endoprosthesis comprising

a cover on at least a portion of a stent element, the cover including a fluoropolymer film that is substantially impermeable to both air and water, such impermeability comprising an air impermeability time measurement of greater than 60 seconds per 100 cc air per 1 cm²of material at 1.2 kPa differential pressure and a water entry pressure through the cover of at least 5 psi (34 KPa).

2. The endoprosthesis of claim 1 wherein the cover includes a stored length.

3. The endoprosthesis of claim 1 wherein the cover comprises expanded polytetrafluoroethylene.

4. The endoprosthesis of claim 3 wherein the stent element includes at least a first segment and a second segment, and wherein the cover is attached to only the first segment.

5. The endoprosthesis of claim 4 wherein the second segment includes an interlocked stent pattern that resists uncontrolled elongation.

6. The endoprosthesis of claim 1 wherein the cover includes a structure having stored length, assisting the covered first segment in bending without kinking.

7. The endoprosthesis of claim 1 wherein the endoprosthesis is delivered at a compacted diameter and the endoprosthesis self-expands to an enlarged deployed diameter.

8. The endoprosthesis of claim 7 wherein the endoprosthesis at its compacted diameter is no more than 12 French.

9. The endoprosthesis of claim 7 wherein the stent element is folded into multiple pleats in its compacted diameter.

10. The endoprosthesis of claim 9 wherein

the stent element comprises a series of forward facing and rearward facing undulations;

and

one series of undulations is folded within the pleats.

11. The endoprosthesis of claim 1 wherein the stent element has a radial stiffness of at least 0.1 kg/mm of diameter with a 1 cm wide loop-test.

12. The endoprosthesis of claim 1 wherein the cover has a thickness of no more than 0.4 mm.