STENT WITH RADIOPAQUE MARKER

• US 20100114298A1
• Filed: 02/21/2008
• Published: 05/06/2010
• Est. Priority Date: 02/21/2007
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Dorn, Juergen, Wack, Thilo
• Granted Patent: US 8,292,950 B2
• Time in Patent Office: Days
• US Class Current: 623/1.230
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

The invention concerns a method of providing a stent with a radiopaque marker comprising the steps of: i) providing in the stent a radiopaque marker carrier portion; ii) sleeving the carrier portion with radiopaque material, with an insulating surface between the carrier and the marker material, and iii) plastically deforming material within the sleeve of radiopaque material, to secure the sleeve on the carrier portion. The invention further concerns a stent with a radiopaque marker, the stent exhibiting a generally annular form with luminal and abluminal major surfaces, the marker also exhibiting opposed major luminal and abluminal surfaces characterised in that i) the marker envelops a carrier portion of the stent and is electrically insulated from it; ii) portions of the material of the marker which exhibit evidence of plastic deformation secure the marker on the carrier portion.

Claims

1. Method of providing a stent with a radiopaque marker comprising the steps of:

i) providing in the stent a radiopaque marker carrier portion

ii) sleeving the carrier portion with radiopaque material, and

iii) plastically deforming material within the sleeve of radiopaque material, to secure the sleeve on the carrier portion

and characterised by the step of;

iv) providing an electrically insulating surface between the carrier portion and the sleeve.

2. Method according to claim 1 or 2, that includes the step of oxidising the surface of the carrier portion that is destined to receive the radiopaque marker material.

3. Method according to claim 1 or claim 2, comprising the further step of v) providing a protective coating on the sleeve.

4. Method according to any one of the preceding claims, wherein the marker is deformed into a shape which exhibits opposed major luminal and abluminal surfaces that are portions of a cylindrical surface with its axis co-incident with that of the stent.

5. Method according to any one of the preceding claims, wherein the carrier portion has a radial thickness less than that of other portions of the stent.

6. Method according to any one of the preceding claims, wherein the plastic deformation step is a swaging step.

7. Method according to any one of the preceding claims, wherein the plastic deformation step comprises applying a radial press force to the sleeve using a contour press tool to radially deform the sleeve.

8. Method according to any one of the preceding claims, wherein the plastic deformation step comprises deforming material within the sleeve so that the material flows to fill a space between the sleeve and the carrier portion.

9. Method according to any one of the preceding claims, wherein the sleeve comprises one or more overhanging portions extending beyond at least one of a proximal and distal end of the carrier portion, the method further comprising the step of folding the at least one or more overhanging portions around the carrier portion.

10. A stent with a radiopaque marker, the stent exhibiting a generally annular form with luminal and abluminal major surfaces, the marker also exhibiting opposed major luminal and abluminal surfaces

characterised in that

i) the marker envelops a carrier portion of the stent

ii) separating the marker and the carrier portion is an electrically insulating surface;

and

iii) portions of the material of the marker which exhibit evidence of plastic deformation secure the marker on the carrier portion.

11. A stent with a radiopaque marker according to claim 10, wherein the portions of the material of the marker which exhibit evidence of plastic deformation secure the marker on the carrier portion by suppressing relative movement between the marker and the carrier portion.

12. A stent with a radiopaque marker according to claim 10 or claim 11, further comprising a layer of material provided between the marker and the carrier portion, the layer of material being more electrically insulating than the marker or the stent.

13. A stent with a radiopaque marker according to claims 10 to 12, further comprising a protective coating on the marker.

14. A stent according to claim 13, wherein the protective coating comprises a polymer, such as fluorinated ethylene propylene (FEP).

15. A stent with a radiopaque marker according to any one of preceding claims 10-14, wherein the marker exhibits opposed major luminal and abluminal surfaces that are each portions of a cylindrical surface with its axis co-incident with that of the stent.

16. A stent with a radiopaque marker according to any one of preceding claims 10-15, wherein the carrier portion has a radial thickness which is less than that of other portions of the stent.

17. A stent with a radiopaque marker according to any one of preceding claims 10-16, wherein the portions of the material of the marker which exhibit evidence of plastic deformation are swaged.

18. A stent with a radiopaque marker according to any one of preceding claims 10-17, wherein the material within the sleeve is deformed so a space between the marker and the carrier portion prior to plastic deformation is filled with material after plastic deformation.

19. A stent with a radiopaque marker according to any one of preceding claims 10-18, wherein the marker comprises a sleeve, the sleeve comprising one or more overhanging portions extending beyond at least one of a proximal and distal end of the carrier portion, wherein the one or more overhanging portions are folded around the carrier portion.

20. A stent with a radiopaque marker according to any one of preceding claims 10-19, wherein the carrier portion comprises a spigot portion.

21. A stent according to any one of preceding claims 10-20, wherein the carrier portion comprises an intermediate portion.

22. A stent with a radiopaque marker according to any one of preceding claims 10-21, wherein the carrier portion comprises a shoulder portion.

23. A stent with a radiopaque marker according to any one of the preceding claims 10-22, wherein the radiopaque material is provided in the form of a seamless tube, wherein the tube is provided with a slit.

24. A stent with a radiopaque marker according to any one of the preceding claims 20-23, wherein the marker extends over at least a portion of at least one of the spigot portion, the intermediate portion and the shoulder portion.

25. A stent with a radiopaque marker according to any one of claims 10-24, wherein the opposed major luminal and abluminal surfaces of the marker once applied to the stent extend in a radial direction beyond the opposed major luminal and abluminal surfaces of the stent.

26. A stent with a radiopaque marker according to any one of claims 10-24, wherein the stent is configured so that the opposed major luminal and abluminal surfaces of the marker once applied to the stent are flush with the luminal and abluminal major surfaces of the stent.