Method for making a covered drug-eluting stent

• US 20060246210A1
• Filed: 04/29/2005
• Published: 11/02/2006
• Est. Priority Date: 04/29/2005
• Status: Abandoned Application

• Current Assignee: LeMaitre Vascular, Incorporated
• Original Assignee: Vascular Architects Incorporated
• Inventors: Alvarado, Angelica, Tecson, Teodoro C., Badesha, Jasbir K., Iki, Kobi, Tsuruda, Marshall
• Application Number:
  US11/119,367
• Publication Number:
  US 20060246210A1
• Time in Patent Office: Days
• US Class Current: 427/2.250
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2/885 comprising a coil including a plurality of spiral or helical sections with alternate directions around a central axis
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 2300/00 Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

A stent, having openings, is mounted onto a mandrel. An agent-containing film is applied onto the stent and the two are pressed against one another so that at least a portion of the film is pressed at least partially into the openings. The film is adhered to the stent. Any excess film is removed to create a stent/film combination which is removed from the mandrel and enclosed within a sleeve of porous material to create a covered agent-eluting stent.

Claims

1. A method for making a covered agent-eluting stent comprising:

obtaining a stent having a stent body with openings formed therein;

mounting the stent onto a mandrel;

applying an agent-containing film onto the stent mounted on the mandrel to create a first subassembly;

pressing the stent and the film against one another to create a second subassembly with at least a portion of the film pressed at least partially into the openings of the stent body;

adhering the film to the stent;

removing any excess film from the second subassembly to create a stent/film combination having inner and outer surfaces;

removing the stent stent/film combination from the mandrel; and

enclosing the stent/film combination within a sleeve of porous material to create a covered agent-eluting stent.

2. The method according to claim 1 wherein the obtaining step comprises obtaining a coiled stent.

3. The method according to claim 1 wherein the obtaining step comprises obtaining a coiled stent having axially spaced-apart turns to define a generally helical gap between the turns.

4. The method according to claim 2 wherein the obtaining step comprises obtaining a coiled stent having an inside diameter when in a relaxed state.

5. The method according to claim 4 further comprising selecting a mandrel having an outside diameter larger than the inside diameter of the coiled stent.

6. The method according to claim 1 wherein the applying step comprises winding a strip of the agent-containing film onto the stent.

7. The method according to claim 1 further comprising:

preparing a flowable agent-containing mixture, the mixture comprising an agent and a matrix material;

spreading the mixture onto a surface; and

at least partially curing the spread mixture to create the agent-containing film.

8. The method according to claim 7 wherein the preparing step is carried out using silicone as the matrix material with the mixture comprising a volatile vehicle;

9. The method according to claim 1 wherein:

the adhering step is carried out before the pressing step; and

the adhering step is carried out using a film having an adhereable surface contacting the stent during the applying step.

10. The method according to claim 9 wherein the adhering step is carried out using a partially cured film.

11. The method according to claim 9 wherein the adhering step is carried out using an adhesive applied to at least one of the film and the stent.

12. The method according to claim 9 further comprising applying a protective layer to the first subassembly before the pressing step and removing the protective layer from the second subassembly after the pressing step.

13. The method according to claim 1 wherein:

the adhering step is carried out after the pressing step; and

the adhering step comprises applying an adhesive to the second subassembly.

14. The method according to claim 13 further comprising:

applying a first protective layer to the first subassembly before the pressing step and removing the first protective layer from the second subassembly after the pressing step; and

applying a second protective layer to the second subassembly after the pressing step and removing the second protective layer from the second subassembly after the second protective layer applying step.

15. The method according to claim 1 wherein they stent removing step is carried out after the excess film removing step.

16. The method according to claim 1 further comprising:

applying a diffusion restrictor on the outer surface of the stent/film combination, said diffusion restrictor permitting passage of the agent through the diffusion restrictor at a first, therapeutic rate; and

applying a diffusion barrier on the inner surface of the stent/film combination, said diffusion barrier preventing passage of the agent through the diffusion barrier at at most a second rate, the second rate being less than the first rate.

17. The method according to claim 16 wherein the applying steps are carried out after the removing step.

18. The method according to claim 16 wherein the diffusion barrier applying step is carried out to create a substantially non-porous vapor-deposited layer of Parylene and the diffusion restrictor applying step is carried out to create a micro-porous vapor-deposited layer of Parylene.

19. The method according to claim 16 further comprising applying a bolus-creating agent-containing material on the diffusion restrictor.

20. The method according to claim 1 wherein the applying step is carried out with an agent-containing film comprising a hydrophilic agent.

21. A method for making a covered agent-eluting stent comprising:

obtaining a coiled stent having a stent body with openings formed therein, the stent having axially spaced-apart turns to define a generally helical gap between the turns;

mounting the stent onto a mandrel;

winding a strip of an agent-containing film onto the stent mounted on the mandrel to create a first subassembly;

pressing the stent and the film against one another to create a second subassembly with at least a portion of the film pressed at least partially into the openings of the stent body;

adhering the film to the stent;

removing any excess film from the stent to create a stent/film combination having inner and outer surfaces;

removing the stent/film combination from the mandrel;

applying a diffusion restrictor on the outer surface of the stent/film combination, said diffusion restrictor permitting passage of the agent through the diffusion restrictor at a first, therapeutic rate;

applying a diffusion barrier on the inner surface of the stent/film combination, said diffusion barrier preventing passage of the agent through the diffusion barrier at at most a second rate, the second rate being less than the first rate;

applying a bolus-creating agent-containing material on the diffusion restrictor; and

enclosing the stent/film combination with the diffusion restrictor, the bolus-creating agent-containing material and the diffusion barrier applied thereto within a sleeve of porous material to create a covered agent-eluting stent.