Grafts and stent grafts having a radiopaque marker

• US 8,636,794 B2
• Filed: 11/09/2006
• Issued: 01/28/2014
• Est. Priority Date: 11/09/2005
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Pathak, Chandrashekhar Prabhakar, Casanova, Michael
• Primary Examiner(s): STEWART, JASON-DENNIS NEILKEN
• Application Number:
  US12/092,636
• Publication Number:
  US 20110125253A1
• Time in Patent Office: 2,637 Days
• Field of Search: 623/1.15, 623/1.34
• US Class Current: 623/1.34
• CPC Class Codes: A61B 5/064 using markers A61B5/062 takes precedence
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: B29C 48/05 Filamentary, e.g. strands
• CPC Class Codes: B29C 48/10 flexible, e.g. blown foils
• CPC Class Codes: B29C 48/18 the components being layers
• CPC Class Codes: B29K 2027/18 PTFE, i.e. polytetrafluorethene , e.g. ePTFE, i.e. expanded polytetrafluorethene
• CPC Class Codes: B29K 2075/00 Use of PU, i.e. polyureas or polyurethanes or derivatives thereof, as moulding material
• CPC Class Codes: B29K 2105/0032 Pigments, colouring agents or opacifiyng agents
• CPC Class Codes: B29L 2031/7542 Catheters

Abstract

A graft device comprising a layer of synthetic non-metallic material having a first surface and a second surface spaced apart from the first surface. The device further, includes a radiopaque marker at least partially embedded in the layer.

Claims

1. A graft device comprising:

an extruded layer of synthetic non-metallic material having a first surface and a second surface spaced apart from the first surface; and

a co-extruded first radiopaque marker and a coextruded second radiopaque marker each at least partially embedded in the layer, the first radiopaque marker being formed of a first radiopaque material and the second radiopaque marker being formed of a second radiopaque material different from the first radiopaque material.

2. The graft device according to claim 1, wherein the first radiopaque marker defines a portion of the first surface.

3. The graft device according to claim 1, wherein the first radiopaque marker defines a portion of the second surface.

4. The graft device according to claim 1, wherein the first radiopaque marker is disposed between the first and second surfaces.

5. The graft device according to claim 1, wherein the synthetic non-metallic material comprises a material selected from a group consisting essentially of Dacron, polyester, PTFE, ePTFE, polyurethane, polyurethaneurea, siloxane, and combinations thereof.

6. The graft device according to claim 1, wherein the first radiopaque marker is formed from a paste having about 20% to about 60% tantalum powder.

7. The graft device according to claim 1, wherein the first radiopaque marker is formed from a paste having about 20% to about 40% Barium Sulfate.

8. The graft device according to claim 7, wherein the Barium Sulfate is mixed with a biocompatible coloring agent.

9. The graft device according to claim 8 wherein the coloring agent is green, blue or black colored.

10. The graft device according to claim 9 wherein the coloring agent is cobalt blue.

11. The graft device according to claim 1, wherein the graft device has a length extending axially from end to end, and the first radiopaque marker comprises a first continuous line that extends along a majority of the length of the graft device.

12. The graft device according to claim 11, wherein the second radiopaque marker comprises a second continuous line parallel to the first continuous line, the second continuous line extending along the majority of the length of the graft device.

13. The graft device according to claim 12, wherein one of the first continuous line is formed from a paste including Barium Sulfate and the second continuous line is formed from a paste including tantalum powder.

14. The graft device according to claim 12, wherein the layer is tubular in shape, and wherein the first continuous line and the second continuous line are formed within a same circumferential third of the layer.

15. A device comprising:

a stent frame;

an extruded synthetic non-metallic material that surrounds a portion of the stent frame, the synthetic non-metallic material having first and second surfaces; and

a first co-extruded radiopaque strip and a second coextruded radiopaque strip embedded in the nonmetallic material, the first radiopaque strip and the second radiopaque strip each formed from a combination of at least two different radiopaque materials.

16. A method of forming a graft device comprising:

extruding a synthetic non-metallic material so as to form a member having a first surface and a second surface spaced apart from the first surface, wherein

extruding includes extruding a first radiopaque material into a first continuous line and extruding a second radiopaque material into a second continuous line such that the first radiopaque material and the second radiopaque material are at least partially embedded in the non-metallic material, the second radiopaque material being different from the first radiopaque material.

17. The method according to claim 16, wherein the member has a length extending axially from a first end to a second end, and extruding further includes extruding the first radiopaque material and the second radiopaque material such that the first continuous line extends along a majority of the length of the member and the second continuous line is parallel to the first continuous line and extends along a majority of the length of the member.

18. The graft device according to claim 16, wherein the synthetic non-metallic material comprises PTFE resin compounded with a hydroxyapatite material, and extruding the synthetic non-metallic material comprises extruding the PTFE resin compounded with the hydroxyapatite material.

19. A graft device comprising:

a layer of synthetic non-metallic material having a first surface and a second surface spaced apart from the first surface; and

a first orientation line and a second orientation line disposed along at least one of the first and second surfaces, the first orientation line formed by a radiopaque marker of a first radiopaque material mixed with a coloring agent coextruded with the layer of synthetic non-metallic material, and the second orientation line formed by a radiopaque marker of a second radiopaque material different from the first material that is not mixed with a coloring agent but is coextruded with the layer of synthetic nonmetallic material.

20. The graft device of claim 19, wherein the first orientation line and the second orientation line form a parallel pair of lines extending along a majority of an end to end axial length of the nonmetallic material.