Radiopaque stent

• US 6,635,082 B1
• Filed: 12/29/2000
• Issued: 10/21/2003
• Est. Priority Date: 12/29/2000
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Hossainy, Syed F. A., Wu, Steven
• Primary Examiner(s): Hale, Gloria M.
• Application Number:
  US09/753,206
• Time in Patent Office: 1,026 Days
• Field of Search: 623/1.15, 623/1.34, 623/1.46, 623/1.1, 623/1.4, 623/1.39, 623/1.49, 623/900, 623/910, 623/920, 623/921, 623/925, 623/926, 606/194, 606/191, 600/1, 600/2, 600/3, 600/36, 128/898, 427/2--, 528/361, 528/115, 428/412
• US Class Current: 623/1.15
• 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 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2210/0095 radioactive
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

A stent or intraductal medical device is provided having radiopaque marker material deposited on the surface of the stent or medical device to assist visualization of the device during implantation. A method for depositing a radiopaque material on an implantable medical device such as a stent is also described. The radiopaque material may be deposited on the medical device by dipping or immersion, or the radiopaque material may be applied to the device using micro-injection or electrodeposition. The radiopaque material may coat the entire surface of the stent, or only a portion of the stent, or it may be applied to cavities or microdepots formed in the outer surface of the medical device. Excess radiopaque material may be removed from the device by centrifugation or shaking, and the radiopaque material may be heated to bond the material to the surface of the device.

Claims

1. A method comprising:

providing an implantable medical device with a plurality of cavities disposed on the outer surface of the device; and

depositing into and retaining radiopaque material in the plurality of cavities to make the device radiopaque.

2. The method of claim 1, wherein depositing comprises:

applying a mixture comprising the radiopaque material onto the device so as to coat at least a portion of the plurality of cavities with the mixture; and

removing an excess quantity of the mixture from the device such that a layer of the mixture is formed in the cavities.

3. The method of claim 2, further comprising preparing the mixture by suspending the radiopaque material in a solution prior to applying the mixture onto the device.

4. The method of claim 2, further comprising preparing the mixture by dissolving the radiopaque material in a solution prior to applying the mixture onto the device.

5. The method of claim 2, wherein applying a mixture comprises immersing at least a portion of the device into the mixture.

6. The method of claim 2, wherein removing excess radiopaque material includes centrifuging the device.

7. The method of claim 2, wherein removing the excess radiopaque material includes shaking the device.

8. The method of claim 1, further comprising affixing the radiopaque material to the device by heating the material to a selected temperature to allow the radiopaque material to bond to the device.

9. The method of claim 1 further comprises affixing the radiopaque material onto the device by drying the material such that the radiopaque material bonds to the device.

10. The method of claim 2, wherein the mixture includes a polymer.

11. The method of claim 1, wherein the radiopaque material is a metal selected from the group of metals consisting of gold, platinum, silver, and tantalum.

12. The method of claim 1, wherein the implantable medical device is a stent.

13. The method of claim 1, wherein depositing a radiopaque material on the device is accomplished using an electrodeposition process.

14. The method of claim 13, wherein depositing comprises:

connecting the device to a cathode of an electrical source;

connecting a mandrel to an anode of an electrical source;

immersing at least a portion of the device in a positively-charged ion mixture comprising the radiopaque material; and

applying an electrical current to the device so as to deposit a layer of the positively-charged ion mixture onto at least a portion of the device.

15. The method of claim 14, further comprising preparing the positively-charged ion mixture prior to immersing at least a portion of the device in the positively-charged ion mixture.

16. The method of claim 14, wherein the radiopaque material in the positively-charged ion mixture is a metal selected from the group of metals consisting of gold, platinum, silver, and tantalum.

17. The method of claim 1, wherein depositing a radiopaque material on the device is accomplished using a micro-injection process.

18. The method of claim 17, further comprising preparing a mixture containing the radiopaque material prior to injecting the mixture into the cavity.

19. The method of claim 17, wherein the radiopaque material is a metal selected from the group of metals consisting of gold, platinum, silver, and tantalum.

20. The method of claim 17, wherein depositing is performed on a stent.

21. The method of claim 8, wherein heating the material comprises heating the radiopaque material to a selected temperature using a gas plasma process so as to cause the radiopaque material to soften and affix onto the device.

22. The method of claim 21, wherein the selected temperature is in a range of approximately 200 to 900 degrees Celsius.

23. The method of claim 22, wherein the gas plasma process uses an inert gas selected from the group of inert gases consisting of argon, helium, neon, krypton and xenon.

24. The method of claim 8, wherein heating the material comprises heating the radiopaque material to a selected temperature using a laser beam light so as to cause the radiopaque material to soften and affix onto the device.

25. The method of claim 24, wherein the selected temperature is in a range of approximately 200 to 900 degrees Celsius.

26. The method of claim 8, wherein heating the material comprises heating the radiopaque material to a selected temperature using an electric arc device so as to cause the radiopaque material to soften and affix onto the device.

27. The method of claim 26, wherein the selected temperature is in a range of approximately 200 to 900 degrees Celsius.

28. The method of claim 2, wherein the layer has a thickness in a range of approximately 1 to 50 μ

m.

29. A stent, comprising:

a plurality of cylindrical elements which are interconnected so as to be generally aligned on a common longitudinal axis;

at least one connecting element for interconnecting the plurality of cylindrical elements;

a plurality of cavities disposed on the outer surface of the plurality of cylindrical elements; and

a radiopaque coating affixed in the plurality of cavities in which the coating is formed by deposition of a radiopaque material.

30. The stent of claim 29, wherein the stent is made of a material selected from the group consisting of metal, polymers, and ceramics.