Coated implantable medical device

• US 8,758,428 B2
• Filed: 10/31/2007
• Issued: 06/24/2014
• Est. Priority Date: 06/07/1995
• Status: Expired due to Fees

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Bates, Brian L., Ragheb, Anthony O., Fearnot, Neal E., Voorhees, William D. III, Kozma, Thomas G.
• Primary Examiner(s): PREBILIC, PAUL B
• Application Number:
  US11/931,678
• Publication Number:
  US 20080147166A1
• Time in Patent Office: 2,428 Days
• Field of Search: 623/1.15, 623 142- 143
• US Class Current: 623/1.42
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• 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 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61K 51/1282 Devices used in vivo and carrying the radioactive therapeutic or diagnostic agent, therapeutic or in vivo diagnostic kits, stents
• CPC Class Codes: A61L 2300/256 Antibodies, e.g. immunoglobulins, vaccines
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 2300/608 having two or more layers
• CPC Class Codes: A61L 27/306 Other specific inorganic materials not covered by A61L27/303 - A61L27/32
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/106 Inorganic materials other than carbon
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61L 31/088 Other specific inorganic materials not covered by A61L31/084 or A61L31/086
• 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
• CPC Class Codes: A61L 33/022 : Metal or alloys
• CPC Class Codes: A61N 5/1002 : Intraluminal radiation therapy
• CPC Class Codes: C08L 65/04 : Polyxylenes

Abstract

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.

Claims

1. A stent comprising:

a generally thin walled cylinder, the cylinder having a plurality of arms comprised of metal, the arms being expandable; and

a plurality of discrete wells formed in the metal of at least one of the arms at locations spaced from one another, with each well of the plurality of discrete wells having a perimeter defined by sidewalls extending downwardly from an outer surface of the arm to a bottom wall extending transversely to and terminating at the sidewalls and providing a closed bottom to the well, with the sidewalls and bottom wall defined by the metal of said at least one of the arms, and with each well of the plurality of discrete wells having an open top and being smaller in all dimensions than the arm, and with each well of the plurality of discrete wells containing a therapeutic agent applied therein and discrete from therapeutic agent applied in other wells of the plurality of wells; and

wherein the therapeutic agent is an immunosuppressive agent.

7. The stent of claim 1 wherein the immunosuppressive agent is cyclosporin.

2. A stent comprising:

a generally thin walled cylinder, the cylinder having a plurality of arms comprised of metal, the arms being expandable; and

a plurality of discrete wells formed in the metal of at least one of the arms at locations spaced from one another, with each well of the plurality of wells having a perimeter defined by sidewalls extending downwardly from an outer surface of the arm to a bottom wall extending transversely to and terminating in the sidewalls and providing a closed bottom to the well, with the sidewalls and bottom wall defined by the metal of said at least one of the arms, and with each well of the plurality of discrete wells having an open top and being smaller in all dimensions than the arm, and with each well of the plurality of discrete wells containing a therapeutic agent applied therein and discrete from therapeutic agent applied in other wells of the plurality of wells.

3. In combination:

a stent comprising a generally thin walled cylinder, the cylinder having a plurality of arms comprised of metal, and a plurality of discrete wells formed in the metal of at least one of the arms at locations spaced from one another, with each well of the plurality of wells having a perimeter defined by sidewalls extending to a bottom wall extending transversely to and terminating in the sidewalls and providing a closed bottom to the well, with the sidewalls and bottom wall defined by the metal of said at least one of the arms, and with each well of the plurality of wells having an open top and being smaller in all dimensions than the arm, and with each well of the plurality of wells containing a therapeutic agent applied therein and discrete from therapeutic agent applied in other wells of the plurality of wells; and

wherein the therapeutic agent is an immunosuppressive agent coated on the well.

4. The combination of claim 3 wherein each well of the plurality of wells is laser cut into the arm.

8. The combination of claim 3 wherein the immunosuppressive agent is cyclo sporin.

5. A stent comprising a generally thin walled structure having a plurality of arms comprised of metal, the arms expandable to assume the shape of a lumen into which the stent is emplaced, and a plurality of discrete wells formed in the metal of at least one of the arms, each well of the plurality of discrete wells having a perimeter defined by sidewalls extending downwardly from a surface of the arm to a bottom wall extending transversely to and terminating in the sidewalls and providing a closed bottom to the well, with the sidewalls and bottom wall defined by the metal of said at least one of the arms, each well of the plurality of wells having an open top and being smaller in all dimensions than the arm, and each well of the plurality of wells containing a therapeutic agent applied therein and discrete from therapeutic agent applied in other wells of the plurality of wells;

and wherein the therapeutic agent is an immunosuppressive agent.

9. The stent of claim 5 wherein the immunosuppressive agent is cyclosporin.

6. A stent comprising:

a generally thin walled cylinder, the cylinder having a plurality of arms comprised of metal, the arms being expandable, and a plurality of discrete wells formed in the metal of at least one of the arms, each well of the plurality of wells having a perimeter defined by sidewalls extending downwardly from a surface of said at least one of the arms to a bottom wall extending transversely to and terminating in the sidewalls and providing a closed bottom to the well, with the sidewalls and bottom wall defined by the metal of said at least one of the arms, each well of the plurality of wells having an open top and being smaller in all dimensions than the arm, and each well of the plurality of wells containing a reservoir of a therapeutic agent applied therein and discrete from reservoirs of therapeutic agent applied in other wells of the plurality of wells.

10. The stent of claim 6 wherein the therapeutic agent is cyclo sporin.

11. A stent including a base material comprised of metal, the base material defining at least one elongate arm having a thickness, wherein a plurality of discrete wells is formed in the metal of the base material of the at least one elongate arm of the stent, wherein each well of the plurality of discrete wells extends only partially through said thickness, wherein each well of the plurality of discrete wells has a perimeter defined by sidewalls extending downwardly from an outer surface of the arm to a bottom wall extending transversely to and terminating in the sidewalls and defining a closed bottom to the well, with the sidewalls and bottom wall defined by the metal of the base material, wherein each well of the plurality of discrete wells has an open top, and wherein each well of the plurality of discrete wells has a bioactive material applied therein and discrete from bioactive material applied in other wells of the plurality of wells.

12. The stent of claim 11, wherein the bioactive material is an immunosuppressive agent.

13. The stent of claim 11, wherein the bioactive material is an anti-proliferative.

14. The stent of claim 11, wherein the bioactive material is an antibiotic.

15. The stent of claim 11, wherein the bioactive material is an anti-inflammatory.

16. The stent of claim 11, wherein the bio active material is a growth factor inhibitor.

17. The stent of claim 11, wherein the bioactive material is a remodeling inhibitor.

18. The stent of claim 12, wherein the immunosuppressive agent is cyclosporin.

19. The stent of claim 11, wherein each well of the plurality of wells is configured as a groove.