Coated implantable medical device
View Patent ↗A coated implantable medical device 10 includes a structure 12 adapted for introduction into the vascular system, esophagus, trachea, colon, biliary tract, or urinary tract; at least one coating layer 16 posited on one surface of the structure; and at least one layer 18 of a bioactive material posited on at least a portion of the coating layer 16 , wherein the coating layer 16 provides for the controlled release of the bioactive material from the coating layer. In addition, at least one porous layer 20 can be posited over the bioactive material layer 18 , wherein the porous layer includes a polymer and provides for the controlled release of the bioactive material therethrough. Preferably, the structure 12 is a coronary stent. The porous layer 20 includes a polymer applied preferably by vapor or plasma deposition and provides for a controlled release of the bioactive material. It is particularly preferred that the polymer is a polyamide, parylene or a parylene derivative, which is deposited without solvents, heat or catalysts, and merely by condensation of a monomer vapor.
1. A stent comprising:
a plurality of metal arms;
a first arm of the plurality of metal arms, the first arm having a first surface facing in a first direction, and a second surface facing in a second direction generally opposite to the first direction,
a first hole or well formed in the metal of the first arm, the first hole or well having an opening defined in the first surface of the first arm,
a layer within the first hole or well, wherein the layer within the first hole or well comprises a therapeutic agent and extends completely across and at least partially fills the first hole or well,
at least a second hole or well formed in the metal of the first arm, with the second hole or well having an opening defined in the first surface of the arm,
a layer within the second hole or well, wherein the layer within the second hole or well comprises the therapeutic agent and extends completely across and at least partially fills the second hole or well,
a segment of the first arm between the first hole or well and the second hole or well, and
at least portions of the first surface and of the second surface on the segment that are free from any layer that comprises the therapeutic agent.
2. The stent of claim 1 , wherein the first hole or well is a hole, and the second hole or well is a hole.
3. The stent of claim 1 , wherein the first hole or well is a well, and the second hole or well is a well.
4. The stent of claim 1 , wherein the therapeutic agent is an immunosuppressive agent.
5. The stent of claim 1 , wherein the therapeutic agent is an antiproliferative agent.
6. The stent of claim 1 , wherein the first hole or well and the second hole or well are cut into the metal so as to have substantially the same size and shape.
7. The stent of claim 4 , wherein the immunosuppressive agent is cyclosporin.
8. The stent of claim 1 , also comprising porous layer material posited over the layer within the first hole or well and over the layer within the second hole or well.
9. The stent of claim 8 , wherein the porous layer material comprises parylene or a parylene derivative.
10. The stent of claim 8 , wherein the porous layer material comprises a bioabsorbable polymer.
11. The device of claim 10 , wherein the bioabsorbable polymer is selected from the group consisting of poly(L-lactic acid), polycaprolactone, poly(lactide-co-glycolide), poly(hydroxybutyrate), poly (hydroxybutyrate-co-valerate), polydioxanone, polyorthoester, polyanhydride, poly(glycolic acid), poly(D,L-lactic acid), poly(glycolic acid-co-trimethylene carbonate), polyphosphoester, polyphosphoester urethane, poly(amino acids), cyanoacrylates, poly(trimethylene carbonate), poly(iminocarbonate), copoly(ether-esters), polyalkylene oxalates, and polyphosphazenes.
12. The device of claim 11 , wherein the bioabsorbable polymer is poly(L-lactic acid) or poly(D,L-lactic acid).
13. The device of claim 11 , wherein the bioabsorbable polymer is poly(lactideco-glycolide).
14. The stent of claim 8 , wherein the porous layer material comprises a biostable polymer.
15. The stent of claim 10 , wherein the first hole or well is a hole, and the second hole or well is a hole.
16. A medical device, comprising:
(a) a metal vascular stent having at least a first metal arm;
(b) at least a first aperture in the metal of the arm at a first position, and at least a second aperture in the metal of the arm at a second position, the first position spaced from the second position along a length of the arm;
(c) the first aperture containing a layer comprising a therapeutic agent and extending completely across and at least partially filling the first aperture, and the second aperture containing a layer comprising the therapeutic agent and extending completely across and at least partially filling the second aperture;
(d) first surface portions of a first side of the arm between the first position and the second position, and second surface portions of a second side of the arm between the first position and the second position;
(e) the first surface portions of the first side of the arm and the second surface portions of the second side of the arm free from any layer comprising the therapeutic agent and;
(f) the first aperture having an opening in the first side of the arm, and the second aperture having an opening in the first side of the arm.
17. The device of claim 16 , wherein the metal vascular stent is a coronary stent.
18. The device of claim 16 , wherein the therapeutic agent is an immunosuppressive agent.
19. The device of claim 16 , wherein the therapeutic agent is an antiproliferative agent.
20. The device of claim 16 , wherein the first aperture and second aperture are cut into the metal so as to have substantially the same size and shape.
21. The device of claim 16 , also comprising porous layer material posited over the layer contained in the first aperture and over the layer contained in the second aperture.
22. The device of claim 21 , wherein the porous layer material comprises a bioabsorbable polymer.
23. The device of claim 22 , wherein the bioabsorbable polymer is selected from the group consisting of poly(L-lactic acid), polycaprolactone, poly(lactide-co-glycolide), poly(hydroxybutyrate), poly (hydroxybutyrate-co-valerate), polydioxanone, polyorthoester, polyanhydride, poly(glycolic acid), poly(D,L-lactic acid), poly(glycolic acid-co-trimethylene carbonate), polyphosphoester, polyphosphoester urethane, poly(amino acids), cyanoacrylates, poly(trimethylene carbonate), poly(iminocarbonate), copoly(ether-esters), polyalkylene oxalates, and polyphosphazenes.
24. The device of claim 23 , wherein the bioabsorbable polymer is poly(L-lactic acid) or poly(D,L-lactic acid).
25. The device of claim 23 , wherein the bioabsorbable polymer is poly(lactide-co-glycolide).
26. The device of claim 21 , wherein the porous layer material comprises a biostable polymer.
27. The device of claim 16 , wherein the apertures are holes.
28. The device of claim 18 , wherein the apertures are holes.
29. The device of claim 19 , wherein the apertures are holes.
30. The device of claim 16 , wherein the apertures are wells.
31. The device of claim 18 , wherein the apertures are wells.
32. The device of claim 19 , wherein the apertures are wells.
33. A stent comprising:
a plurality of metal arms;
a first hole or well formed in the metal of at least a first arm of the plurality of metal arms;
a layer within the first hole or well, wherein the layer within the first hole or well comprises a therapeutic agent and extends completely across and at least partially fills the first hole or well;
at least a second hole or well formed in the metal of the first arm;
a layer within the second hole or well, wherein the layer within the second hole or well comprises the therapeutic agent and extends completely across and at least partially fills the second hole or well;
a segment of the first arm between the first hole or well and the second hole or well, the segment having a first surface and a second surface opposite the first surface;
at least portions of the first surface and of the second surface of the segment that are free from any layer that comprises the therapeutic agent; and
porous layer material posited over the layer within the first hole or well and over the layer within the second hole or well.
34. The stent of claim 33 , wherein the porous layer material comprises parylene or a parylene derivative.
35. The stent of claim 33 , wherein the porous layer material comprises a bioabsorbable polymer.
36. The device of claim 35 , wherein the bioabsorbable polymer is selected from the group consisting of poly(L-lactic acid), polycaprolactone, poly(lactide-co-glycolide), poly(hydroxybutyrate), poly (hydroxybutyrate-co-valerate), polydioxanone, polyorthoester. polyanhydride, poly(glycolic acid), poly(D,L-lactic acid), poly(glycolic acid-co-trimethylene carbonate), polyphosphoester, polyphosphoester urethane, poly(amino acids), cyanoacrylates, poly(trimethylene carbonate), poly(iminocarbonate), copoly(ether-esters), polyalkylene oxalates, and polyphosphazenes.
37. The device of claim 36 , wherein the bioabsorbable polymer is poly(L-lactic acid) or poly(D,L-lactic acid).
38. The device of claim 36 , wherein the bioabsorbable polymer is poly(lactide-co-glycolide).
39. The stent of claim 33 , wherein the porous layer material comprises a biostable polymer.
40. The stent of claim 35 , wherein the first hole or well is a hole, and the second hole or well is a hole.
41. A medical device, comprising:
a metal vascular stent having at least a first metal arm;
at least a first aperture in the metal of the arm at a first position, and at least a second aperture in the metal of the arm at a second position, the first position spaced from the second position along a length of the arm;
the first aperture containing a layer comprising a therapeutic agent and extending completely across and at least partially filling the first aperture, and the second aperture containing a layer comprising the therapeutic agent and extending completely across and at least partially filling the second aperture;
first surface portions of a first side of the arm between the first position and the second position, and second surface portions of a second side of the arm between the first position and the second position;
the first surface portions and the second surface portions free from any layer comprising the therapeutic agent; and
porous layer material posited over the layer contained in the first aperture and over the layer contained in the second aperture.
42. The device of claim 41 , wherein the porous layer material comprises a bioabsorbable polymer.
43. The device of claim 42 , wherein the bioabsorbable polymer is selected from the group consisting of poly(L-lactic acid), polycaprolactone, poly(lactide-co-glycolide), poly(hydroxybutyrate), poly (hydroxybutyrate-co-valerate), polydioxanone, polyorthoester, polyanhydride, poly(glycolic acid), poly(D,L-lactic acid), poly(glycolic acid-co-trimethylene carbonate), polyphosphoester, polyphosphoester urethane, poly(amino acids), cyanoacrylates, poly(trimethylene carbonate), poly(iminocarbonate), copoly(ether-esters), polyalkylene oxalates, and polyphosphazenes.
44. The device of claim 43 , wherein the bioabsorbable polymer is poly(L-lactic acid) or poly(D,L-lactic acid).
45. The device of claim 43 , wherein the bioabsorbable polymer is poly(lactide-co-glycolide).
46. The device of claim 41 , wherein the porous layer material comprises a biostable polymer.
47. A medical device, comprising:
a metal vascular stent having at least a first metal arm;
at least a first aperture in the metal of the arm at a first position, and at least a second aperture in the metal of the arm at a second position, the first position spaced from the second position along a length of the arm;
the first aperture containing a layer comprising a therapeutic agent and extending completely across and at least partially filling the first aperture;
first surface portions of a first side of the arm between the first position and the second position, and second surface portions of a second side of the arm between the first position and the second position;
the first surface portions and the second surface portions free from any layer comprising the therapeutic agent; and
porous layer material posited over the layer contained in the first aperture.
48. The device of claim 47 , wherein the porous layer material comprises a bioabsorbable polymer.
49. The device of claim 48 , wherein the bioabsorbable polymer is selected from the group consisting of poly(L-lactic acid), polycaprolactone, poly(lactide-co-glycolide), poly(hydroxybutyrate), poly (hydroxybutyrate-co--valerate), polydioxanone, polyorthoester, polyanhydride, poly(glycolic acid), poly(D,L-lactic acid), poly(glycolic acid-co-trimethylene carbonate), polyphosphoester, polyphosphoester urethane, poly(amino acids), cyanoacrylates, poly(trimethylene carbonate) poly(iminocarbonate), copoly(ether-esters), polyalkylene oxalates, and polyphosphazenes.
50. The device of claim 49 , wherein the bioabsorbable polymer is poly(L-lactic acid) or poly(D,L-lactic acid).
51. The device of claim 49 , wherein the bioabsorbable polymer is poly(lactide-co-glycolide).
52. The device of claim 47 , wherein the porous layer material comprises a biostable polymer.