COATED IMPLANTABLE MEDICAL DEVICE

• US 20110196479A1
• Filed: 04/18/2011
• Published: 08/11/2011
• Est. Priority Date: 06/07/1995
• Status: Abandoned Application

• Current Assignee: Cook Incorporated (Cook Group Incorporated), MED Institute, Inc. (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated), MED Institute, Inc. (Cook Group Incorporated)
• Inventors: Feamot, Neal E., Bates, Brian L., Kozma, Thomas G., Ragheb, Anthony O., Voorhees, William D. III
• Application Number:
  US13/088,862
• Publication Number:
  US 20110196479A1
• Time in Patent Office: Days
• US Class Current: 623/1.42
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/02 Prostheses implantable into the body closure means for urethra or rectum or for artificial body openings therefor A61F2/0004
• CPC Class Codes: A61F 2/06 Blood vessels
• 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 2/91 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 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• 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 2420/08 Coatings comprising 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: A61P 37/06 : Immunosuppressants, e.g. drugs for graft rejection
• CPC Class Codes: C08L 65/04 : Polyxylenes

Abstract

A coated implantable medical device includes a structure adapted for introduction into the vascular system, esophagus, trachea, colon, biliary tract, or urinary tract; at least one coating layer posited on one surface of the structure; and at least one layer of a bioactive material posited on at least a portion of the coating layer. Preferably the structure is a stent graft.

Claims

1. A medical device, comprising:

a structure having at least one surface and being composed of a base material;

at least one coating layer comprising a polymer posited on the at least one surface of the structure; and

at least one layer comprising a first bioactive material posited over at least a portion of the at least one coating layer, wherein the first bioactive material is selected from the group consisting of vasodilators, antimicrobials, antibiotics, antimitotics, antiproliferatives, antisecretory agents, non-steroidal antiinflammatory drugs, immunosuppressive agents, growth factor antagonists, and antioxidants;

wherein said at least one coating layer provides for a controlled release of the first bioactive material.

2. The medical device of claim 1, wherein the polymer is selected from the group consisting of parylene, polyurethanes, silicones and polyesters.

3. The medical device of claim 2, wherein the polymer is a polyurethane.

4. The medical device of claim 1, wherein polymer is selected from the group consisting of polyimide, poly(ethylene oxide), poly(ethylene glycol), poly(propylene oxide), silicone, polytetrafluoroethylene, tetramethyldisiloxane, parylene, parylene derivative, and a polymer of methane.

5. The medical device of claim 1, wherein the polymer is parylene or a parylene derivative.

6. The medical device of claim 1, wherein the structure is a stent.

7. The medical device of claim 1, wherein the at least one layer comprising the first bioactive material is the outermost layer of the medical device.

8. The medical device of claim 1, wherein the at least one layer comprising the first bioactive material further comprises a second bioactive material.

9. The medical device of claim 8, wherein the first bioactive material is paclitaxel or a paclitaxel derivative.

10. The medical device of claim 9, wherein the second bioactive material is an anti-inflammatory agent.

11. The medical device of claim 8, wherein one of the first bioactive material or the second bioactive material is an anti-inflammatory agent.

12. The medical device of claim 8, wherein the first bioactive material and the second bioactive material are co-mixed.

13. The medical device of claim 1, wherein the at least one coating layer comprises a non-porous material.

14. The medical device of claim 1 wherein the at least one coating layer has a thickness in a range from 50,000 to 500,000 Angstroms.

15. The medical device of claim 1, wherein the polymer is selected from the group consisting of a polyurethane, silicones, polyesters, polyimide, poly(ethylene oxide), poly(ethylene glycol), poly(propylene oxide), silicone, polytetrafluoroethylene, tetramethyldisiloxane, parylene, and a parylene derivative;

wherein the medical device is a stent; and

wherein the first bioactive material is paclitaxel or a paclitaxel derivative.

16. The medical device of claim 15, wherein the at least one layer comprising the first bioactive material further comprises a second bioactive material;

and wherein the second bioactive material is an anti-inflammatory agent.

17. The medical device of claim 16, wherein the at least one layer of a first bioactive material is the outermost layer of the medical device.

18. The medical device of claim 1, wherein the polymer is selected from the group consisting of polyimide, poly(ethylene oxide), poly(ethylene glycol), poly(propylene oxide), silicone, polytetrafluoroethylene, tetramethyldisiloxane, parylene, and a parylene derivative;

and

wherein the first bioactive material is paclitaxel or a paclitaxel derivative.

19. The medical device of claim 18, wherein at least one layer comprising the first bioactive material further comprises a second bioactive material;

and wherein the second bioactive material is an anti-inflammatory agent.