Coated vascular devices

• US 20030204168A1
• Filed: 07/30/2002
• Published: 10/30/2003
• Est. Priority Date: 04/30/2002
• Status: Abandoned Application

• Current Assignee: Wyeth (Pfizer Inc.)
• Original Assignee: Wyeth (Pfizer Inc.)
• Inventors: van der Meulen, De heer Joost, Bosma, Gjalt
• Application Number:
  US10/208,581
• Publication Number:
  US 20030204168A1
• Time in Patent Office: Days
• US Class Current: 604/103.02
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/0684 having a forming anvil staying above the tissue during stapling
• CPC Class Codes: A61B 17/0686 having a forming anvil staying below the tissue during stapling
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61F 2/01 Filters implantable into blood vessels
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• 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 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/005 : Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0067 : conical
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2230/0093 : Umbrella-shaped, e.g. mushroom-shaped
• CPC Class Codes: A61F 2250/0067 : Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2310/0097 : Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics
• CPC Class Codes: A61L 2300/41 : Anti-inflammatory agents, e.g. NSAIDs
• 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 2300/42 : Anti-thrombotic agents, anticoagulants, anti-platelet agents
• CPC Class Codes: A61L 2300/608 : having two or more layers
• 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: A61M 2025/0057 : Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
• CPC Class Codes: A61M 2025/105 : having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1075 : having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 25/0045 : multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61P 9/08 : Vasodilators for multiple indications
• CPC Class Codes: A61P 9/14 : Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers

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. A vascular filter for implantation into a living organism comprising:

a substantially tubular body formed from a plurality of longitudinally arranged first elements and a plurality of second elements connected to the plurality of first elements and to each other, the plurality of second elements forming a lattice structure for capturing particulate matter;

a biocompatible vehicle affixed to at least a portion of the substantially tubular body; and

at least one agent in therapeutic dosages incorporated into the biocompatible vehicle for the treatment of a disease condition.

2. The vascular filter for implantation into a living organism according to claim 1, wherein the biocompatible vehicle comprises a polymeric matrix.

3. The vascular filter for implantation into a living organism according to claim 2, wherein the polymeric matrix comprises poly(ethylene-co-vinylacetate) and polybutylmethacrylate.

4. The vascular filter for implantation into a living organism according to claim 3, wherein the polymeric matrix comprises first and second layers, the first layer making contact with at least a portion of the substantially tubular body and comprising a solution of poly(ethylene-co-vinylacetate) and polybutylmethacrylate, and the second layer comprising polybutylmethacrylate.

5. The vascular filter for implantation into a living organism according to claim 4, wherein the at least one agent is incorporated into the first layer.

6. The vascular filter for implantation into a living organism according to claim 2, wherein the biocompatible vehicle comprises a polyfluoro copolymer comprising polymerized residue of a first moiety selected from the group consisting of vinylidenefluoride and tetrafluoroethylene, and polymerized residue of a second moiety other than the first moiety and which is copolymerized with the first moiety, thereby producing the polyfluoro copolymer, wherein the relative amounts of the polymerized residue of the first moiety and the polymerized residue of the second moiety are effective to produce the biocompatible vehicle with properties effective for use in coating implantable medical devices when the coated medical device is subjected to a predetermined maximum temperature, and a solvent in which the polyfluoro copolymer is substantially soluble.

7. The vascular filter for implantation into a living organism according to claim 6, wherein the polyfluoro copolymer comprises from about fifty to about ninety-two weight percent of the polymerized residue of the first moiety copolymerized with from about fifty to about eight weight percent of the polymerized residue of the second moiety.

8. The vascular filter for implantation into a living organism according to claim 6, wherein said polyfluoro copolymer comprises from about fifty to about eighty-five weight percent of the polymerized residue of vinylidenefluoride copolymerized with from about fifty to about fifteen weight percent of the polymerized residue of the second moiety.

9. The vascular filter for implantation into a living organism according to claim 6, wherein said copolymer comprises from about fifty-five to about sixty-five weight percent of the polymerized residue of the vinylidenefluoride copolymerized with from about forty-five to about thirty-five weight percent of the polymerized residue of the second moiety.

10. The vascular filter for implantation into a living organism according to claim 6, wherein the second moiety is selected from the group consisting of hexafluoropropylene, tetrafluoroethylene, vinylidenefluoride, 1-hydropentafluoropropylene, perfluoro (methyl vinyl ether), chlorotrifluoroethylene, pentafluoropropene, trifluoroethylene, hexafluoroacetone and hexsafluoroisobutylene.

11. The vascular filter for implantation into a living organism according to claim 6, wherein the second moiety is hexafluoropropylene.

12. The vascular filter for implantation into a living organism according to claim 1, wherein the at least one agent comprises an anti-proliferative.

13. The vascular filter for implantation into a living organism according to claim 1, wherein the at least one agent comprises an anti-inflammatory.

14. The vascular filter for implantation into a living organism according to claim 1, wherein the at least one agent comprises an anti-coagulant.

15. The vascular filter for implantation into a living organism according to claim 1, wherein the at least one agent comprises rapamycin.

16. The vascular filter for implantation into a living organism according to claim 1, wherein the at least one agent comprises heparin.

17. A removable percutaneous vascular filter system for blocking micro-and macro-emboli in a vessel while allowing continued perfusion of blood, comprising:

a guidewire having distal and proximal ends;

a filter including a non-metallic, porous, flexible filter membrane having a distal portion and a proximal free portion and a filter membrane support structure extending from the flexible filter membrane distal portion to at least the flexible filter membrane proximal portion, wherein the filter membrane distal portion in pivotally attached to the guidewire near the distal end of the guidewire and wherein the filter membrane proximal free end portion is substantially parallel to the guidewire in its collapsed state;

deploying means operatively connected to the filter to cause the filter membrane proximal free end portion to move from a position substantially parallel to the guidewire to a position removed from the longitudinal axis of the guidewire to cause the flexible filter membrane to form a substantially conical shape to form a generally sealing relationship with the wall of the vessel;

a biocompatible vehicle affixed to at least a portion of the filter; and

at least one agent in therapeutic dosages incorporated into the biocompatible vehicle for the treatment of a disease condition.

18. The removable percutaneous vascular filter system according to claim 17, wherein the biocompatible vehicle comprises a polymeric matrix.

19. The removable percutaneous vascular filter system according to claim 18, wherein the polymeric matrix comprises poly(ethylene-co-vinylacetate) and polybutylmethacrylate.

20. The removable percutaneous vascular filter system according to claim 19, wherein the polymeric matrix comprises first and second layers, the first layer making contact with at least a portion of the filter and comprising a solution of poly(ethylene-co-vinylacetate) and polybutylmethacrylate and the second layer comprising polybutylmethacrylate.

21. The removable percutaneous vascular filter system according to claim 20, wherein the at least one agent is incorporated into the first layer.

22. The removable percutaneous vascular filter system according to claim 18, wherein the biocompatible vehicle comprises a polyfluoro copolymer comprising polymerized residue of a first moiety selected from the group consisting of vinylidenefluoride and tetrafluoroethylene, and polymerized residue of a second moiety other than the first moiety and which is copolymerized with the first moiety, thereby producing the polyfluoro copolymer, wherein the relative amounts of the polymerized residue of the first moiety and the polymerized residue of the second moiety are effective to produce the biocompatible vehicle with properties effective for use in coating implantable medical devices when the coated medical device is subjected to a predetermined maximum temperature, and a solvent in which the polyfluoro copolymer is substantially soluble.

23. The removable percutaneous vascular filter system according to claim 22, wherein the polyfluoro copolymer comprises from about fifty to about ninety-two weight percent of the polymerized residue of the first moiety copolymerized with from about fifty to about eight weight percent of the polymerized residue of the second moiety.

24. The removable percutaneous vascular filter system according to claim 22, wherein the polyfluoro copolymer comprises from about fifty to about eighty-five weight percent of the polymerized residue of vinylidenefluoride copolymerized with from about fifty to about fifteen weight percent of the polymerized residue of the second moiety.

25. The removable percutaneous vascular filter system according to claim 22, wherein said copolymer comprises from about fifty-five to about sixty-five weight percent of the polymerized residue of the vinylidenefluoride copolymerized with from about forty-five to about thirty-five weight percent of the polymerized residue of the second moiety.

26. The removable percutaneous vascular filter system according to claim 22, wherein the second moiety is selected from the group consisting of hexafluoropropylene, tetrafluoroethylene, vinylidenefluoride, 1-hydropentafluoropropylene, perfluoro (methyl vinyl ether), chlorotrifluoroethylene, pentafluoropropene, trifluoroethylene, hexafluoroacetone and hexafluoroisobutylene.

27. The removable percutaneous vascular filter system according to claim 22, wherein the second moiety is hexafluoropropylene.

28. The removable percutaneous vascular filter system according to claim 17, wherein the at least one agent comprises an anti-proliferative.

29. The removable percutaneous vascular filter system according to claim 17, wherein the at least one agent comprises an anti-inflammatory.

30. The removable percutaneous vascular filter system according to claim 17, wherein the at least one agent comprises an anti-coagulant.

31. The removable percutaneous vascular filter system according to claim 17, wherein the at least one agent comprises rapamycin.

32. The removable percutaneous vascular filter system according to claim 17, wherein the at least one agent comprises heparin.

33. The removable percutaneous vascular filter system according to claim 17, wherein the at least one agent comprises dexamethasone.