Coated implantable medical device

• US 20070050010A1
• Filed: 09/01/2006
• Published: 03/01/2007
• Est. Priority Date: 06/07/1995
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated), MED Institute, Inc. (Cook Group Incorporated)
• Inventors: Grewe, David, Bates, Brian, Kozma, Thomas, Fearnot, Neal, Schaeffer, Darin, Ragheb, Anthony, Voorhees, William
• Granted Patent: US 7,867,275 B2
• Time in Patent Office: Days
• US Class Current: 623/1.150
• 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 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. An implantable medical device, comprising:

a structure adapted for introduction into a patient, the structure having at least one surface, being composed of a base material, and comprising a seamless sheet of biocompatible material having a pattern in a surface of said seamless sheet, said pattern including in said seamless sheet a reinforcing member extending longitudinally therealong and a plurality of cells extending laterally from said reinforcing member, selected of said cells each being a closed cell, having a fixedly sized aperture extending through said surface of said seamless sheet, a segment extending laterally from said reinforcing member and disposed at least partially around the aperture of the cell, each segment of said selected cells being separated from any other cell in said stent; and

a first coating layer posited on one surface of the structure, the first coating layer comprising a first bioactive material selected from the group consisting of thrombolytics, vasodilators, antihypertensive agents, antimicrobials, antibiotics, antimitotics, antiproliferatives, antisecretory agents, non-steroidal anti-inflammatory drugs, immunosuppressive agents, growth factors, growth factor antagonists, antitumor agents, chemotherapeutic agents, antipolymerases, antiviral agents, photodynamic therapy agents, antibody targeted therapy agents, prodrugs, sex hormones, free radical scavengers, antioxidants, biologic agents, radiotherapeutic agents, radiopaque agents and radiolabelled agents.

2. The stent of claim 1, further comprising a porous coating layer posited over the first coating layer, the porous coating layer comprising a polyurethane.

3. The stent of claim 2, wherein the porous coating layer further comprises a polyurethane urea.

4. The stent of claim 3, wherein the bioactive material is paclitaxel.

5. The stent of claim 3, wherein the base material comprises a self-expanding nickel titanium alloy.

6. The stent of claim 4, further comprising a second coating layer posited on one surface of the porous coating layer, the second coating layer comprising a second bioactive material selected from the group consisting of antiproliferatives, immunosuppressive agents, antithrombogenics and thrombolytics.

7. The stent of claim 1, wherein the first coating layer further comprises a polyetherurethane urea blended with a siloxane containing surface modifying additive.

8. The stent of claim 1, wherein the first bioactive material is selected from the group consisting of antiproliferatives, immunosuppressive agents, and thrombolytics.

9. The stent of claim 1, wherein the base material is selected from the group consisting of stainless steel, tantalum, titanium, a self-expanding nickel titanium alloy, gold, inconel, iridium, silver, and tungsten.

10. The stent of claim 1, further comprising a third coating layer posited between one surface of the structure and the first coating layer, the third coating layer comprising a polyurethane and a polyurethane urea.

11. A stent comprising:

a structure adapted for introduction into a patient, the structure having at least one surface, being composed of a base material and having a serpentine configuration including a series of straight sections and a plurality of bends, said straight sections being joined by said bends to form a series of alternating loops, said serpentine configuration being formed into a cylindrical shape having a longitudinal axis, wherein said straight sections are bent into generally circular configurations surrounding and generally perpendicular to said axis; and

a first coating layer posited on one surface of the structure, the first coating layer comprising a first bioactive material selected from the group consisting of antithrombogenics, thrombolytics, vasodilators, antihypertensive agents, antimicrobials, antibiotics, antimitotics, antiproliferatives, antisecretory agents, non-steroidal anti-inflammatory drugs, immunosuppressive agents, growth factors, growth factor antagonists, antitumor agents, chemotherapeutic agents, antipolymerases, antiviral agents, photodynamic therapy agents, antibody targeted therapy agents, prodrugs, sex hormones, free radical scavengers, antioxidants, biologic agents, radiotherapeutic agents, radiopaque agents and radiolabelled agents.

12. The stent of claim 11, further comprising a porous coating layer posited over the first coating layer, the porous coating layer comprising a polyurethane.

13. The stent of claim 12, wherein the porous coating layer further comprises a polyetherurethane urea.

14. The stent of claim 13, wherein the bioactive material is paclitaxel.

15. The stent of claim 13, wherein the base material comprises a self-expanding nickel titanium alloy.

16. The stent of claim 14, further comprising a second coating layer posited on one surface of the porous coating layer, the second coating layer comprising a second bioactive material selected from the group consisting of antithrombogenics, antiproliferatives, immunosuppressive agents, antithrombogenic and thrombolytics.

17. The stent of claim 11, wherein the first coating layer further comprises a polyetherurethane urea blended with a siloxane containing surface modifying additive.

18. The stent of claim 11, wherein the first bioactive material is selected from the group consisting of antiproliferatives, immunosuppressive agents, and thrombolytics.

19. The stent of claim 11, wherein the base material is selected from the group consisting of stainless steel, tantalum, titanium, a self-expanding nickel titanium alloy, gold, inconel, iridium, silver, and tungsten.

20. The stent of claim 11, further comprising a third coating layer posited between one surface of the structure and the first coating layer, the third coating layer comprising a polyurethane and a polyurethane urea.