Biologically degradable compositions for medical applications

• US 8,846,070 B2
• Filed: 07/29/2008
• Issued: 09/30/2014
• Est. Priority Date: 03/29/2004
• Status: Expired due to Fees

• Current Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Tang, Yiwen, Hossainy, Syed F. A., Tung, Andrew C., Pacetti, Stephen D.
• Primary Examiner(s): FISHER, ABIGAIL L
• Application Number:
  US12/182,066
• Publication Number:
  US 20080279898A1
• Time in Patent Office: 2,254 Days
• Field of Search: 424/423, 424/425, 424/426, 424/400, 514/772.3
• US Class Current: 424/423
• CPC Class Codes: A61L 2420/06 Coatings containing a mixture of two or more compounds
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

A medical article is disclosed, comprising a biologically degradable AB block copolymer and a biologically degradable polymer that is capable, at equilibrium and at room temperature, of absorbing less than about 5 mass % water.

Claims

1. A medical article comprising:

(a) a medical substrate; and

(b) a coating deposited on the substrate, the coating comprising a first polymer and a second polymer, wherein the first polymer is a biologically degradable AB block copolymer, and the second polymer is a biologically degradable polymer that is capable of absorbing, as determined at equilibrium and at room temperature, less than 5% water by mass of the biologically degradable polymer,

wherein the AB block-copolymer is of the formula;

2. The medical article of claim 1, wherein the ratio between the first polymer and the second polymer is 1:

19.

3. The medical article of claim 1, wherein the medical article is a stent, graft, or a stent-graft.

4. The medical article of claim 1, wherein the second polymer does not include or is substantially free from AB polymeric blocks.

5. The medical article of claim 1, additionally comprising a therapeutic substance.

6. The medical article of claim 1, wherein at least one coating layer in the coating on the substrate comprises both the first polymer and the second polymer.

7. The medical article of claim 6, wherein the at least one coating layer comprising both the first and the second polymers is the outermost layer.

8. The medical article of claim 7, wherein the outermost layer is a reservoir layer.

9. The medical article of claim 7, wherein the outermost layer is a topcoat layer.

10. The medical article of claim 6, wherein the coating further comprises at least one member of the group consisting of poly(butyl methacrylate), poly(ethyl methacrylate), and poly(ethyl methacrylate-co-butyl methacrylate).

11. The medical article of claim 10, wherein the at least one layer comprising the first and the second polymer comprises the at least one member of the group consisting of poly(butyl methacrylate), poly(ethyl methacrylate), and poly(ethyl methacrylate-co-butyl methacrylate).

12. The medical article of claim 10, wherein a layer other than the at least one layer comprising the first and the second polymer comprises the at least one member of the group consisting of poly(butyl methacrylate), poly(ethyl methacrylate), and poly(ethyl methacrylate-co-butyl methacrylate).

13. The medical article of claim 5, wherein the therapeutic substance is selected from the group consisting of tacrolimus, dexamethasone, rapamycin, 40-0-(2-hydroxy)ethyl-rapamycin (everolimus), 40-0-(3-hydroxy)propyl-rapamycin, 40-0-[2-(2-hydroxy)ethoxy]ethyl-rapamycin, and 40-0-tetrazole-rapamycin, and combinations thereof.

14. The medical article of claim 5, wherein the therapeutic substance is rapamycin, everolimus, 40-0-tetrazole-rapamycin, or a combination thereof.

15. The medical article of claim 5, wherein the therapeutic substance is selected from the group consisting of paclitaxel, docetaxel, methotrexate, azathioprine, vincristine, vinblastine, fluorouracil, doxorubicin Hydrochloride, mitomycin, and combinations thereof.

16. The medical article of claim 1, wherein in the AB block-copolymer the ratio of PEG units and the PBT units is between about 0.67:

1 and about 9;

1 and the molecular weight of the PEG units is between about 300 and about 4000 Daltons.

17. A method of treating a disorder in a human being, comprising:

implanting in the human being the medical article as defined in claim 1, 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, claudication, anastomotic proliferation for vein and artificial grafts, bile duct obstruction, ureter obstruction, tumor obstruction, and combinations thereof.