IMPLANTABLE DEVICES FORMED ON NON-FOULING METHACRYLATE OR ACRYLATE POLYMERS

• US 20100119571A1
• Filed: 11/13/2009
• Published: 05/13/2010
• Est. Priority Date: 03/24/2005
• Status: Active Grant

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: PACETTI, STEPHEN D.
• Granted Patent: US 8,932,615 B2
• Time in Patent Office: Days
• US Class Current: 424/422
• 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 2300/606 Coatings
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/14 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61L 33/064 obtained by reactions only involving carbon-to-carbon unsaturated bonds A61L33/062 takes precedence
• CPC Class Codes: C08L 33/14 of esters containing halogen, nitrogen, sulfur, or oxygen atoms in addition to the carboxy oxygen

Abstract

Implantable devices formed of or coated with a material that includes a polymer having a non-fouling acrylate or methacrylate polymer are provided. The implantable device can be used for treating or preventing a disorder such as atherosclerosis, thrombosis, restenosis, hemorrhage, vascular dissection or perforation, vascular aneurysm, vulnerable plaque, chronic total occlusion, patent foramen ovale, claudication, anastomotic proliferation for vein and artificial grafts, bile duct obstruction, ureter obstruction, tumor obstruction, or combinations thereof.

Claims

1. An implantable device having a coating comprising a polymer that comprises repeating units of Formula I:

wherein R₁ and R₂ are H; and

R₃, R₄ and R₅ are independently H, C1-C4 alkyl groups, silyl groups, siloxy groups, and phenyl,

wherein Z is NH, and

wherein X is O, S, or NR₆ where R₆ is H, C1-C4 alkyl, or phenyl.

2. The implantable device of claim 1, wherein R₃, R₄, R₅, and R₆ are independently CH₃, ethyl, propyl, isopropyl, isobutyl, sec-butyl, or n-butyl.

3. The implantable device of claim 1, wherein X is O or NH.

4. The implantable device of claim 1, further comprising a biocompatible polymer, blended or bonded with the polymer according to claim 1.

5. The implantable device of claim 1, further comprising a bioactive agent.

6. The implantable device of claim 5, wherein the bioactive agent is selected from the group consisting of paclitaxel, docetaxel, estradiol, nitric oxide donors, super oxide dismutases, super oxide dismutases mimics, 4-amino-2,2,6,6-tetramethylpiperidine-1-oxyl(4-amino-TEMPO), tacrolimus, dexamethasone, rapamycin, rapamycin derivatives, 40-O-(2-hydroxy)ethyl-rapamycin(everolimus), 40-O-(3-hydroxy)propyl-rapamycin, 40-O-[2-(2-hydroxy)ethoxy]ethyl-rapamycin, and 40-O-tetrazole-rapamycin, ABT-578, clobetasol, prodrugs thereof, co-drugs thereof, and a combination thereof.

7. The implantable device of claim 1 which is a stent.

8. The implantable device of claim 6, which is a stent.

9. A biostable device formed of a material comprising a polymer that comprises repeating units of Formula I:

wherein R₁ and R₂ are H; and

R₃, R₄ and R₅ are independently H, C1-C4 alkyl groups, silyl groups, siloxy groups, and phenyl,

wherein Z is NH, and

wherein X is O, S, or NR₆ where R₆ is H, C1-C4 alkyl, or phenyl.

10. The biostable device of claim 9, wherein R₁, R₂, R₃, R₄, R₅, and R₆ are independently CH₃, ethyl, propyl, isopropyl, or n-butyl.

11. The biostable device of claim 9, wherein X is O or NH.

12. The biostable device of claim 9, further comprising a bioactive agent.

13. The biostable device of claim 12, wherein the bioactive agent is selected from the group consisting of paclitaxel, docetaxel, estradiol, nitric oxide donors, super oxide dismutases, super oxide dismutases mimics, 4-amino-2,2,6,6-tetramethylpiperidine-1-oxyl(4-amino-TEMPO), tacrolimus, dexamethasone, rapamycin, rapamycin derivatives, 40-O-(2-hydroxy)ethyl-rapamycin(everolimus), 40-O-(3-hydroxy)propyl-rapamycin, 40-O-[2-(2-hydroxy)ethoxylethyl-rapamycin, and 40-O-tetrazole-rapamycin, ABT-578, clobetasol, prodrugs thereof, co-drugs thereof, and a combination thereof.

14. The implantable device of claim 9 which is a stent.

15. A method of treating a disorder in a patient comprising implanting in the patient the impantable device of claim 9, wherein the disorder is selected from the group consisting of atherosclerosis, thrombosis, restenosis, hemorrhage, vascular dissection or perforation, vascular aneurysm, vulnerable plaque, chronic total occlusion, patent foramen ovale, claudication, anastomotic proliferation for vein and artificial grafts, bile duct obstruction, ureter obstruction, tumor obstruction, and combinations thereof

16. A method of treating a disorder in a patient comprising implanting in the patient the impantable device of claim 14, wherein the disorder is selected from the group consisting of atherosclerosis, thrombosis, restenosis, hemorrhage, vascular dissection or perforation, vascular aneurysm, vulnerable plaque, chronic total occlusion, patent foramen ovale, claudication, anastomotic proliferation for vein and artificial grafts, bile duct obstruction, ureter obstruction, tumor obstruction, and combinations thereof.