Stent with radiopaque coating consisting of particles in a binder

• US 6,355,058 B1
• Filed: 12/30/1999
• Issued: 03/12/2002
• Est. Priority Date: 12/30/1999
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Pacetti, Stephen, Mroz, Joanna
• Primary Examiner(s): Willse, David H.
• Assistant Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US09/475,378
• Time in Patent Office: 803 Days
• Field of Search: 623/1.34, 623/1.46, 606/194, 528/361, 427/2--
• US Class Current: 623/1.15
• CPC Class Codes: A61L 29/18 Materials at least partially X-ray or laser opaque
• CPC Class Codes: A61L 31/18 Materials at least partially X-ray or laser opaque
• CPC Class Codes: C25F 3/22 of heavy metals

Abstract

A stent configuration wherein particles of radiopaque material contained within a polymeric binder is coated onto a stent core structure to enhance the radiopacity of the stent. The stent is initially formed and rendered radiopaque after all surfaces are coated with the radiopaque coating. The amount of particles of radiopaque materials can be varied (by volume) within the binder to either increase or decrease the radiopacity of the binder coating in order to obtain an optimal amount of radiopacity to the stent. The thickness of the coating also can be varied to fine tune the radiopacity of the stent.

Claims

1. A radiopaque stent, comprising:

a central core structure defining the shape of the stent; and

a biocompatible outer radiopaque coating having particles of a radiopaque material dispersed within a binder which coats the central core structure, wherein the size of the particles of radiopaque material is no more than one tenth of the thickness of the coating.

2. The stent of claim 1, wherein said central core structure is made from a material selected from the group consisting of stainless steel alloys, cobalt chromium alloys, titanium alloys, and cobalt-chromium molybdenum alloys.

3. The stent of claim 1, wherein said central core structure is made from a nickel-titanium alloy.

4. The stent of claim 1, wherein said radiopaque particle material is formed from the group of materials consisting of gold, platinum, iridium, tantalum, silver, molybdenum, iodine and its salts or compounds, barium and its salts or compounds, bismuth and its salts or compounds, tungsten, rhenium, osmium, noble metals and palladium.

5. The stent of claim 1, wherein radiopaque coating has a thickness in the range of 0.1 to 25 microns.

6. The stent of claim 1, wherein the percentage of particles of radiopaque material within the binder is in the range of 10% to 66% by volume.

7. The stent of claim 1, wherein the percentage of particles of radiopaque material within the binder is approximately 15-40% by volume.

8. The stent of claim 1, wherein the binder is formed from the group of materials consisting of polymers and biopolymers.

9. The stent of claim 1, wherein the binder consists of a polymer which is biostable.

10. The stent of claim 1, wherein the binder is formed from the group of materials consisting of polytetrafluoroethylene, fluorinated ethylene-propylene, polyvinylidene fluoride, silicone, polyether urethanes, polycarbonate urethanes, urethanes containing surface modifying additives where these additives provide silicone, hydrocarbon, polyethylene glycol, or perfluorocarbon chains on the surface, polyurethanes with surface modifying endgroups consisting of silicone, hydrocarbon, polyethylene glycol or perfluoropolymer chains, olefinic polymers including polyethylene and polypropylene, ethylene polymers such as ethylene vinyl acetate and ethylene covinyl alcohol, and polymide, polyetheretherketone, polyaryletherketone and polysulfone.

11. The stent of claim 1, wherein the binder is formed from the group of materials consisting of L-polylactide, polylactic acid, polyglycolic acid, copolymers of lactic and glycolic acid, polycaprolactone, polyanhydrides, polyphosphoesters, polyphosphazenes, polyhydroxyvalerate, and polyhydroxybutyrate.

12. The stent of claim 1, wherein the binder is formed from the group of materials consisting of fibrin, elastin, hyaluronic acid, chondroitin sulfate, heparin sulfate, heparin sulfate with hydrophobic counterions, heparin covalently bonded to the underlying surface, albumin, gelatin, and collagen.

13. The stent of claim 1, wherein said radiopaque material is applied to all surfaces of the central core.

14. The stent of claim 1, wherein said radiopaque material is applied to less than all surfaces of the central core.

15. A method for forming a radiopaque stent, comprising the steps of:

providing a tube of structural material;

forming voids in said tube to render said tube expandable; and

coating said expandable tube with a binder having particles of a radiopaque material, wherein the size of the particle of radiopaque material is no more than one-tenth of the thickness of the coating.

16. The method of claim 15, further comprising the step of electropolishing said expandable tube prior to said coating step.

17. The method of claim 15, wherein said voids are formed in said tube by laser cutting.

18. The method of claim 15, wherein the method of coating the expandable tube includes spraying, dipping, brushing, wiping, pad printing, elecrostatic liquid spraying, and electrostatic powder coating.

19. The method of claim 15, wherein said radiopaque coating is applied to all portions of said expandable tube.

20. The method of claim 15, wherein said radiopaque coating is applied to only selected portions of said expandable tube.

21. The method of claim 15, wherein the particles of radiopaque material are selected from the group consisting of iodine and its salts or compounds, barium and its salts or compounds, bismuth and its salts or compounds, tungsten, rhenium, osmium, noble metals, palladium, gold, colloidal gold, molybdenum, silver, platinum, tantalum, iridium and their alloys.

22. A radiopaque stent, comprising:

a central core structure defining the shape of said stent; and

a biocompatible outer radiopaque coating having particles of a radiopaque material dispersed within a binder which coats the central core structure, the particles being made from a material having temporary radiopacity.

23. The stent of claim 22, wherein said central core structure is made from a material selected from the group consisting of stainless steel alloys, cobalt chromium alloys, titanium alloys, and cobalt-chromium molybdenum alloys.

24. The stent of claim 22, wherein said central core structure is made from a nickel-titanium alloy.

25. The stent of claim 22, wherein the radiopaque material is formed from 1-polylactide containing barium or iodine salts.

26. The stent of claim 22, wherein radiopaque coating has a thickness in the range of 0.1 to 25 microns.