GRAFTS AND STENT GRAFTS HAVING A RADIOPAQUE MARKER

• US 20110125253A1
• Filed: 11/09/2006
• Published: 05/26/2011
• 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 P., Casanova, R. Michael
• Granted Patent: US 8,636,794 B2
• Time in Patent Office: Days
• 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:

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

a radiopaque marker at least partially embedded in the layer.

2. The graft device according to claim 1, wherein the radiopaque marker is fully embedded in the material.

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

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

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

6. 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, polyurethane-urea, siloxane, and combinations thereof.

7. The graft device according to claim 1, wherein the radiopaque marker is a paste having about 20% tantalum powder.

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

9. The graft device according to claim 8 wherein the Barium Sulfate in mixed with a biocompatible coloring agent.

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

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

12. The graft device according to claim 1, wherein the radiopaque marker comprises at least one line that extends along a substantial portion of the length of the graft.

13. The graft device according to claim 12, wherein the at least one line comprises two parallel lines that extends along a substantial portion of the length of the graft.

14. 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 radio-opaque ink printed on at least one of the first and second surfaces of the synthetic non-metallic material.

15. A device comprising:

a stent frame;

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

a radiopaque strip embedded in the non-metallic material.

16. A method of verifying orientation of a graft in a mammalian body subsequent to implantation of such graft in the mammalian body without an incision into the body, the method comprising:

directing electromagnetic energies at the implanted graft;

blocking some of electromagnetic energies through a portion of the graft; and

forming an image on a display medium that shows the portion as a line that extends along a substantial length of the graft.

17. 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 radiopaque material at least partially embedded in the non-metallic material.

18. A method of verifying orientation of a graft in a mammalian body subsequent to implantation of such graft in the mammalian body without an incision into the body, the method comprising:

directing electromagnetic energies at the implanted graft;

blocking some of electromagnetic energies through a portion of the graft; and

forming an image on a display medium that shows the portion as a line that extends along a substantial length of the graft; and

contrasting the line to a reference datum.

19. The method of claim 18, wherein the contrasting includes contrasting the line to a reference stent-graft under the same electromagnetic energies.

20. 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

an orientation line disposed along at least one of the first and second surfaces, the orientation line having radiopaque marker and a coloring agent.

21. The graft device of claim 20, wherein the orientation line extends along the axial length of the non-metallic material.

22. The graft device of claim 20, wherein the orientation line is one of a parallel pair of lines extending along the axial length of the non-metallic material.