Method of manufacturing a covered stent

• US 20050255230A1
• Filed: 05/17/2004
• Published: 11/17/2005
• Est. Priority Date: 05/17/2004
• Status: Abandoned Application

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Miller, Kathleen M., Clerc, Claude O.
• Application Number:
  US10/846,706
• Publication Number:
  US 20050255230A1
• Time in Patent Office: Days
• US Class Current: 427/2.100
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

A method of manufacturing a covered stent having a sufficiently thick covering to retain a therapeutically effective amount of a therapeutic agent. The covering is applied to the entire outer surface of the stent to provide sufficient volume for retention of the therapeutic agent. In certain embodiments, the stent has a plurality of openings that are covered by the covering. The invention is particularly suited for certain applications, such as for the manufacture of non-vascular stents.

Claims

1. A method of manufacturing a covering stent comprising:

providing a stent having a distal end and a proximal end and comprising a plurality of segments defining a plurality of openings therebetween;

preparing a viscous mixture comprising a polymer, a solvent, and a therapeutic agent;

applying the viscous mixture to the stent to form a covering on the plurality of segments and the plurality of openings; and

allowing the solvent to evaporate.

2. The method of claim 1, wherein the stent is a non-vascular stent.

3. The method of claim 2, wherein the non-vascular stent is selected from the group consisting of a esophageal stent, biliary stent, pancreatic stent, tracheal stent, lamygeal stent, bronchial stent, prostatic stent, urethral stent, ureteral stent, duodenal stent, and a colonic stent.

4. The method of claim 1, wherein at least one of the proximal end and the distal end are not covered with the covering.

5. The method of claim 1, wherein the polymer is bioresorbable.

6. The method of claim 1, wherein the polymer is silicone, polyurethane or co-polymers thereof.

7. The method of claim 1, wherein the polymer is styrene-isobutylene-styrene.

8. The method of claim 1, wherein the viscous mixture has a viscosity of between about 50 centipoise and about 500 centipoise.

9. The method of claim 1, wherein the polymer percent weight of the viscous mixture is between about 5% and about 25%.

10. The method of claim 9, wherein the polymer percent weight of the viscous mixture is between about 22% and about 23.5%.

11. The method of claim 1, wherein the polymer is silicone and the percent weight silicone of the mixture is between about 20% and about 25%.

12. The method of claim 1, wherein the percent weight of the therapeutic agent in the viscous mixture is between about 0. 1% and about 6%.

13. The method of claim 1, wherein the percent weight of therapeutic agent in the covering after the solvent has evaporated is between about 0.4% and about 50%.

14. The method of claim 1, wherein the therapeutic agent is selected from the group consisting of an antimicrobial agent, antibiotic, anti-inflammatory agent, analgesic agent, anesthetic agent, and anti-cancer agent.

15. The method of claim 1, wherein the step of applying the viscous mixture comprises dipping the stent in the viscous mixture.

16. The method of claim 1, wherein the step of applying the viscous mixture comprises spraying the stent with the viscous mixture.

17. A method of manufacturing a covered stent comprising:

providing a stent comprising a hollow tube having a continuous outer surface;

preparing a viscous mixture comprising a polymer, a solvent, and a therapeutic agent;

applying the viscous mixture to the stent to form a covering on the entire continuous outer surface of the stent; and

allowing the solvent to evaporate.

18. The method of claim 17, wherein the stent is a non-vascular stent.

19. The method of claim 17, wherein the non-vascular stent is selected from the group consisting of a esophageal stent, biliary stent, pancreatic stent, tracheal stent, larnygeal stent, bronchial stent, prostatic stent, urethral stent, ureteral stent, duodenal stent, and a colonic stent.

20. The method of claim 17, wherein the viscous mixture has a viscosity between about 50 centipoise and about 500 centipoise.

21. A method of manufacturing a covered stent comprising:

providing a stent having an outer surface;

preparing a viscous mixture comprising a polymer, a solvent, and a therapeutic agent, the viscous mixture having a viscosity between about 1 10 centipoise and about 190 centipoise;

applying the viscous mixture to the entire outer surface of the stent; and

allowing the solvent to evaporate.

22. The method of claim 21, wherein the stent is a non-vascular stent.

23. The method of claim 22, wherein the non-vascular stent is selected from the group consisting of a esophageal stent, biliary stent, pancreatic stent, tracheal stent, larnygeal stent, bronchial stent, prostatic stent, urethral stent, ureteral stent, a duodenal stent, and a colonic stent.

24. A method of treating a non-vascular target site comprising:

providing a non-vascular stent having an outer surface that is entirely covered with a covering comprising a polymer and a therapeutic agent;

delivering the non-vascular stent to the non-vascular target site; and

allowing the therapeutic agent to be released into the non-vascular target site to treat the non-vascular target site.