Method for making a covered drug-eluting stent

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.