Coated implantable medical device

• US 8,469,943 B2
• Filed: 10/12/2010
• Issued: 06/25/2013
• 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., Kozma, Thomas G., Voorhees, William D. III
• Primary Examiner(s): PREBILIC, PAUL B
• Application Number:
  US12/902,788
• Publication Number:
  US 20110046723A1
• Time in Patent Office: 987 Days
• Field of Search: 604/508, 604/523, 623 142- 143
• US Class Current: 604/523
• 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 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. An implantable medical device, comprising:

a catheter or a portion of a catheter adapted for introduction into a patient, the catheter or a portion of a catheter having at least one surface;

a non-porous coating layer applied to the at least one surface of the catheter or a portion of a catheter, the coating layer being one of the group consisting of adsorbent and absorbent;

at least one layer comprising paclitaxel or a derivative of paclitaxel posited over the at least one surface of the catheter or a portion of a catheter and over the non-porous coating layer, wherein the at least one layer comprising paclitaxel or a derivative of paclitaxel is adsorbed on or absorbed into the at least one coating layer; and

at least one porous layer posited over the at least one layer comprising paclitaxel or a derivative of paclitaxel,

wherein the at least one porous layer and the non-porous coating layer include the same polymer.

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

3. The device of claim 1, wherein the at least one porous layer provides for a controlled release of the paclitaxel or a derivative of paclitaxel through the at least one porous layer.

5. The device of claim 1, including multiple independent layers comprising paclitaxel or a derivative of paclitaxel posited over the at least one surface of the catheter or a portion of a catheter.

6. The device of claim 1, wherein the layers are independently applied.

7. The device of claim 1, wherein the at least one porous layer is a surface-processed layer.

8. The device of claim 1, further comprising an overcoat applied to the at least one porous layer.

9. The device of claim 8, wherein the overcoat comprises polyethylene oxide.

10. The device of claim 8, wherein the overcoat comprises phosphatidylcoline.

11. The device of claim 8, wherein the overcoat comprises a covalently-bound bioactive material.

12. The device of claim 1, wherein the at least one porous layer is porous prior to implantation of the device.

13. The device of claim 1, wherein the at least one porous layer includes parylene or a parylene derivative.

14. The device of claim 6, wherein the at least one porous layer includes parylene or a parylene derivative.

15. The device of claim 6, wherein the at least one porous layer includes polyimide.

16. The device of claim 1, wherein the at least one porous layer when first posited forms a network resembling a fibrous mesh with pores.

17. The device of claim 1, wherein the at least one porous layer comprises parylene or a parylene derivative, and wherein size of the pores is controlled by the amount of parylene or parylene derivative posited.

18. The device of claim 1, wherein the at least one porous layer is posited without a solvent.

4. A medical device comprising:

a catheter or portion of a catheter adapted for introduction into a patient, the catheter or portion of a catheter having at least one surface;

at least one layer comprising paclitaxel or a derivative of paclitaxel posited over the at least one surface of the catheter or portion of a catheter;

at least one porous layer posited over the at least one layer comprising paclitaxel or a derivative of paclitaxel, the porous layer being porous when first posited over the at least one layer comprising paclitaxel or a derivative of paclitaxel; and

at least one coating layer posited over the at least one surface of the catheter or portion of a catheter;

wherein the at least one layer comprising paclitaxel or a derivative of paclitaxel is posited over at least a portion of the at least one coating layer, wherein the at least one layer comprising paclitaxel or a derivative of paclitaxel is adsorbed on or absorbed into the at least one coating layer, and wherein the at least one coating layer provides for a controlled release of the paclitaxel or a derivative of paclitaxel from the at least one layer comprising paclitaxel or a derivative of paclitaxel.

19. The device of claim 4, wherein the layers are independently applied.

20. The device of claim 4, wherein the at least one porous layer is a surface-processed layer.