Grafts and stent grafts having a radiopaque marker

• US 9,155,491 B2
• Filed: 01/23/2014
• Issued: 10/13/2015
• 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
• Primary Examiner(s): STEWART, JASON-DENNIS NEILKEN
• Application Number:
  US14/162,551
• Publication Number:
  US 20140135619A1
• Time in Patent Office: 628 Days
• Field of Search: 623/1.15, 623/1.34, 606/108
• US Class Current: 1/1
• 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 method of verifying location and/or orientation of an implanted prosthesis in a body without an incision into the body, the method comprising:

directing electromagnetic energies at the implanted prosthesis, wherein the implanted prosthesis comprises an extruded layer of synthetic non-metallic material having a coextruded first radiopaque marker and a coextruded second radiopaque marker each at least partially embedded in the layer, the first radiopaque marker including a first radiopaque material and the second radiopaque marker including a second radiopaque material different from the first radiopaque material, wherein the first radiopaque marker and the second radiopaque marker block some of the electromagnetic energies from passing through a portion of the implanted prosthesis; and

forming an image on a display medium that gives a visual indication of the first radiopaque marker and the second radiopaque marker.

2. The method of claim 1, wherein forming the image on the display medium includes the visual indication of the first radiopaque marker and the second radiopaque marker being formed as lines that extend along a substantial length of the implanted prosthesis.

3. The method of claim 2, wherein forming the image on the display medium includes the visual indication of the first radiopaque marker and the second radiopaque marker being formed as continuous lines that extend along a majority of the length of the implanted prosthesis.

4. The method of claim 1, further comprising contrasting the visual indication to a reference datum.

5. The method of claim 4, wherein the contrasting includes contrasting the visual indication to an image of a reference prosthesis under similar electromagnetic energies.

6. The method of claim 1, further comprising determining, by viewing the image, whether the implanted prosthesis has been twisted or kinked.

7. The method of claim 6, wherein the first radiopaque marker and the second radiopaque marker are lines extending along a substantial length of the implanted prosthesis, and wherein determining whether the implanted prosthesis has been twisted or kinked includes determining whether the visual indication shows at least one of the lines as a spiral indicating that the implanted prosthesis is twisted.

8. The method of claim 6, wherein the first radiopaque marker and the second radiopaque marker are lines extending along a substantial length of the implanted prosthesis, and wherein determining whether the implanted prosthesis has been twisted or kinked includes determining whether the visual indication shows at least one of the lines as having an intersecting point rather than a smooth inflection curve indicating that the implanted prosthesis is kinked.

9. The method of claim 1, wherein the first radiopaque marker and the second radiopaque marker each include a combination of at least two different radiopaque materials.

10. A method of verifying location and/or orientation of a prosthesis in a body while implanting the prosthesis in the body, the method comprising:

inserting the prosthesis into a desired region of the body, wherein the prosthesis comprises an extruded layer of synthetic non-metallic material having a coextruded first radiopaque marker and a coextruded second radiopaque marker each at least partially embedded in the layer, the first radiopaque marker including a first radiopaque material and the second radiopaque marker including a second radiopaque material different from the first radiopaque material;

directing electromagnetic energies at the prosthesis in the desired region, wherein the first radiopaque marker and the second radiopaque marker block some of the electromagnetic energies from passing through a portion of the implanted prosthesis;

forming an image on a display medium that gives a visual indication of the first radiopaque marker and the second radiopaque marker;

adjusting the position and/or orientation of the prosthesis after viewing the visual indication on the image.

11. The method of claim 10, wherein forming the image on the display medium includes the visual indication of the first radiopaque marker and the second radiopaque marker being formed as lines that extend along a substantial length of the prosthesis.

12. The method of claim 11, wherein forming the image on the display medium includes the visual indication of the first radiopaque marker and the second radiopaque marker being formed as continuous lines that extend along a majority of the length of the prosthesis.

13. The method of claim 10, further comprising contrasting the visual indication to a reference datum.

14. The method of claim 13, wherein the contrasting includes contrasting the visual indication to an image of a reference prosthesis under similar electromagnetic energies.

15. The method of claim 10, further comprising determining, by viewing the image, whether the prosthesis has been twisted or kinked.

16. The method of claim 15, wherein the first radiopaque marker and the second radiopaque marker are lines extending along a substantial length of the prosthesis, and wherein determining whether the prosthesis has been twisted or kinked includes determining whether the visual indication shows at least one of the lines as a spiral indicating that the prosthesis is twisted.

17. The method of claim 15, wherein the first radiopaque marker and the second radiopaque marker are lines extending along a substantial length of the prosthesis, and wherein determining whether the prosthesis has been twisted or kinked includes determining whether the visual indication shows at least one of the lines as having an intersecting point rather than a smooth inflection curve indicating that the prosthesis is kinked.

18. A method of obtaining information regarding an implanted prosthesis in a body without an incision into the body, the method comprising:

directing electromagnetic energies at the implanted prosthesis, wherein the implanted prosthesis includes encoded indicia printed on the implanted prosthesis using radiopaque ink, wherein the encoded indicia block some of the electromagnetic energies from passing through a portion of the implanted prosthesis;

forming an image on a display medium that gives a visual indication of the encoded indicia; and

using the visual indication of the encoded indicia to obtain information regarding the implanted prosthesis

wherein the encoded indicia comprise a bar code, and

wherein using the visual indication of the encoded indicia to obtain information regarding the implanted prosthesis includes using a device to interpret the visual indication of the bar code as digital code.

19. The medical device according to claim 18, wherein the bar code comprises a series of black and white lines with certain thickness and heights that can be interpreted by the machine as digital code, which can be used in a computer database.