Medical devices, drug coatings and methods of maintaining the drug coatings thereon

• US 20060222756A1
• Filed: 05/19/2006
• Published: 10/05/2006
• Est. Priority Date: 09/29/2000
• Status: Abandoned Application

• Current Assignee: Wyeth (Pfizer Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Wilson, David J., Narayanan, Pallassana V., Davila, Luis A., Lentz, David Christian, Llanos, Gerard H., Roller, Mark B., Shaw, William Douglas Jr., Silver, James H., Trepanier, Christine, Scopelianos, Angelo George, Spaltro, John, Scheidt, Karl K., Pelton, Alan Roy, Mendez, Jorge Orlando
• Application Number:
  US11/437,572
• Publication Number:
  US 20060222756A1
• Time in Patent Office: Days
• US Class Current: 427/2.240
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/115 Staplers for performing anastomosis in a single operation
• CPC Class Codes: A61B 2017/06028 by means of a cylindrical longitudinal blind bore machined at the suture-receiving end of the needle, e.g. opposite to needle tip
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• 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 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2310/0097 Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics
• CPC Class Codes: A61F 2310/00976 Coating or prosthesis-covering structure made of proteins or of polypeptides, e.g. of bone morphogenic proteins BMP or of transforming growth factors TGF
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/436 : the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
• CPC Class Codes: A61K 31/727 : Heparin; Heparan
• CPC Class Codes: A61K 45/06 : Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61L 17/145 : Coating
• 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 2300/608 : having two or more layers
• CPC Class Codes: A61L 27/34 : Macromolecular materials
• CPC Class Codes: A61L 29/085 : Macromolecular materials
• CPC Class Codes: A61L 31/022 : Metals or alloys
• 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 31/18 : Materials at least partially X-ray or laser opaque
• CPC Class Codes: A61P 9/00 : Drugs for disorders of the cardiovascular system
• CPC Class Codes: B05D 1/18 : performed by dipping
• CPC Class Codes: B05D 3/0254 : After-treatment
• CPC Class Codes: B05D 3/0493 : using vacuum
• CPC Class Codes: C08L 27/12 : containing fluorine atoms
• CPC Class Codes: C08L 27/14 : Homopolymers or copolymers of vinyl fluoride
• CPC Class Codes: C08L 27/16 : Homopolymers or copolymers or vinylidene fluoride

Abstract

Medical devices, and in particular implantable medical devices, may be coated to minimize or substantially eliminate a biological organism'"'"'s reaction to the introduction of the medical device to the organism. The medical devices may be coated with any number of biocompatible materials. Therapeutic drugs, agents or compounds may be mixed with the biocompatible materials and affixed to at least a portion of the medical device. These therapeutic drugs, agents or compounds may also further reduce a biological organism'"'"'s reaction to the introduction of the medical device to the organism. Various materials and coating methodologies may be utilized to maintain the drugs, agents or compounds on the medical device until delivered and positioned.

Claims

1. (canceled)

2. A drug delivery device comprising an intraluminal stent, rapamycin or a macrocyclic triene analog thereof, and a biocompatible polyfluoro copolymer.

3. A drug delivery device according to claim 2 wherein the stent bears a coating that comprises said polyfluoro copolymer and rapamycin or macrocyclic triene analog thereof.

4. A drug delivery device according to claim 3 further comprising at least one additional layer comprising a polyfluoro copolymer.

5. A drug delivery device according to claim 4 wherein said layer is disposed between said stent and said coating.

6. A drug delivery device according to claim 4 wherein said layer overlays said coating.

7. A drug delivery device according to claim 6 further comprising an additional layer that comprises a polyfluoro copolymer and overlays said coating.

8. A drug delivery device according to claim 2 wherein said polyfluoro copolymer comprises hexafluoropropylene (HFP), tetrafluoroethylene (TFE), vinylidene fluoride, 1-hydropentafluoropropylene, perfluoro(methyl vinyl ether), chlorotrifluoroethylene (CTFE), pentafluoropropene, trifluoroethylene, hexafluoroacetone or hexafluoroisobutylene.

9. A drug delivery device according to claim 8 wherein said polyfluoro copolymer comprises hexafluoropropylene (HFP).

10. A drug delivery device according to claim 8 wherein said polyfluoro copolymer comprises vinylidene fluoride.

11. A drug delivery device according to claim 8 wherein said polyfluoro copolymer comprises polyvinylidinefluoride copolymerized with HFP.

12. A drug delivery device according to claim 11 wherein said polyfluoro copolymer comprises from about fifty to about ninety-two weight percent vinylidinefluoride copolymerized with from about fifty to about eight weight percent HFP.

13. A drug delivery device according to claim 12 wherein said polyfluoro copolymer comprises from about fifty to about eighty-five weight percent vinylidinefluoride copolymerized with from about fifty to about fifteen weight percent HFP.

14. A drug delivery device according to claim 13 wherein said polyfluoro copolymer comprises from about fifty-five to about seventy weight percent vinylidinefluoride copolymerized with from about forty-five to about thirty weight percent HFP.

15. A drug delivery device according to claim 14 wherein said polyfluoro copolymer comprises from about fifty-five to about sixty-five weight percent vinylidinefluoride copolymerized with from about forty-five to about thirty-five weight percent HFP.

16. A drug delivery device according to claim 3 wherein said rapamycin or macrocyclic triene analog thereof constitutes from about 0.001 weight percent to about seventy weight percent of said coating.

17. A drug delivery device according to claim 2 that delivers said rapamycin or macrocyclic triene analog thereof at a dose of from about 0.001 μ

g/cm² to 100 μ

g/cm² at any of hours 1 to about 2000 following intraluminal implantation.

18. A drug delivery device according to claim 17 that delivers said rapamycin or macrocyclic triene analog thereof at a dose of from about 0.001 μ

g/cm² to 100 μ

g/cm² at any of hours 2 to about 800 following intraluminal implantation.

19. A drug delivery device according to claim 3 wherein said coating further comprises an additional polymer.

20. A drug delivery device according to claim 19 wherein said additional polymer is a hydrophilic polymer or a hydrophobic polymer.

21. A drug delivery device according to any one of claims 2 to 20 wherein said rapamycin or macrocyclic triene analog thereof is a macrocyclic triene analog of rapamycin that binds FKBP12.

22. A drug delivery device according to claim 21 wherein said polyfluoro copolymer comprises hexafluoropropylene (HFP), tetrafluoroethylene (TFE), vinylidene fluoride, 1-hydropentafluoropropylene, perfluoro(methyl vinyl ether), chlorotrifluoroethylene (CTFE), pentafluoropropene, trifluoroethylene, hexafluoroacetone or hexafluoroisobutylene.

23. A method for inhibiting neointimal hyperplasia in a human comprising implanting intraluminally in said human a drug delivery device according to any one of claims 2 to 20.

24. A drug delivery device comprising a stent bearing a coating that comprises rapamycin or a macrocyclic triene analog thereof and a polymer component that comprises at least one polyfluoro copolymer.

25. A drug delivery device according to claim 24 wherein said polymer component comprises a blend of said polyfluoro copolymer and an additional polymer.

26. A drug delivery device according to claim 24 wherein said polyfluoro copolymer comprises hexafluoropropylene (HFP), tetrafluoroethylene (TFE), vinylidene fluoride, 1-hydropentafluoropropylene, perfluoro(methyl vinyl ether), chlorotrifluoroethylene (CTFE), pentafluoropropene, trifluoroethylene, hexafluoroacetone or hexafluoroisobutylene.

27. A drug delivery device according to claim 26 wherein said polyfluoro copolymer comprises hexafluoropropylene (HFP).

28. A drug delivery device according to claim 26 wherein said polyfluoro copolymer comprises vinylidene fluoride.

29. A drug delivery device according to claim 26 wherein said polyfluro copolymer is polyvinylidinefluoride/HFP copolymer.

30. A drug delivery device according to claim 24 wherein said rapamycin or macrocyclic triene analog thereof constitutes from about 0.001 weight percent to about seventy weight percent of said coating.

31. A drug delivery device according to claim 24 that delivers said rapamycin or macrocyclic triene analog thereof at a rate of from about 0.001 μ

g/cm² to 100 μ

g/cm² at any of hours 1 to about 2000 following intraluminal implantation.

32. A drug delivery device according to claim 31 that delivers said rapamycin or macrocyclic triene analog thereof at a rate of from about 0.001 μ

g/cm² to 100 μ

g/cm² at any of hours 2 to about 800 following intraluminal implantation.

33. A method for inhibiting neointimal hyperplasia in a human comprising implanting intraluminally in said human a drug delivery device according to any one of claims 24 to 32.

34. A method according to claim 33 wherein said rapamycin or macrocyclic triene analog thereof is a macrocyclic triene analog of rapamycin that binds FKBP12.