Poly(hydroxyalkanoate-co-ester amides) and agents for use with medical articles

• US 7,361,726 B2
• Filed: 02/08/2007
• Issued: 04/22/2008
• Est. Priority Date: 01/14/2005
• Status: Expired due to Fees

• Current Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Pacetti, Stephen D., Hossainy, Syed F. A.
• Primary Examiner(s): BOYKIN, TERRESSA M
• Application Number:
  US11/704,829
• Publication Number:
  US 20070149724A1
• Time in Patent Office: 439 Days
• Field of Search: 424/78.3, 424/423, 525/54.1, 525/54.2, 528/271, 528/272
• US Class Current: 528/272
• CPC Class Codes: A61L 2300/802 Additives, excipients, e.g. cyclodextrins, fatty acids, surfactants
• 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: C08G 63/6852 derived from hydroxy carboxylic acids
• CPC Class Codes: C08G 69/44 Polyester-amides
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence
• CPC Class Codes: C08L 77/12 Polyester-amides
• CPC Class Codes: C09D 167/00 Coating compositions based on polyesters obtained by reactions forming a carboxylic ester link in the main chain based on polyester-amides C09D177/12; based on polyester-imides C09D179/08; Coating compositions based on derivatives of such polymers

Abstract

Polymers containing poly(hydroxyalkanoate-co-ester amides) and agents for use with medical articles are disclosed along with methods of fabricating medical articles comprising these polymers. The medical articles generally comprise an implantable substrate having a coating containing a poly(hydroxyalkanoate-co-ester amide).

Claims

1. A a poly(hydroxyalkanoate-co-ester amide) polymer of a formula:

2. The polymer of claim 1, wherein A comprises units derived from a hydroxyalkanoate selected from the group consisting of 3-hydroxybutyrate, 4-hydroxybutyrate, 3-hydroxyvalerate, 3-hydroxybutyrate-co-valerate, caprolactone, lactide, glycolide, lactide-co-glycolide, and combinations thereof.

3. The polymer of claim 1, wherein at least one of L₁, B, L₂ or X comprises a therapeutic agent.

4. The polymer of claim 3, wherein the agent is connected to the polymer.

5. The polymer of claim 3, wherein the agent is blended with the polymer.

6. The polymer of claim 1, wherein the poly(ester amide) comprises a component selected from a group consisting of

7. The polymer of claim 6, comprising

8. The polymer of claim 6, comprising

9. The polymer of claim 1, comprising

10. The polymer of claim 1, comprising

11. The polymer of claim 1, comprising

12. The polymer of claim 1, wherein at least one of L₁, B, L₂ or X comprises an agent selected from a group consisting of elastin, silk-elastin, collagen, atrial natriuretic peptide (ANP), Arg-Gly-Asp (RGD);

and any derivatives, analogs, homologues, congeners, salts, copolymers and combinations thereof.

13. The polymer of claim 3, wherein the agent comprises a free radical scavenger, a nitric oxide donor, rapamycin, methyl rapamycin, 42-Epi-(tetrazoylyl) rapamycin, everolimus, tacrolimus, paclitaxel, docetaxel, estradiol, clobetasol, idoxifen, tazarotene and any prodrugs, metabolites, analogs, homologues, congeners, or derivatives, salts or combinations thereof.

14. The polymer of claim 13, wherein the free radical scavenger comprises a component selected from a group consisting of 2,2′

,6,6′

-tetramethyl-1-piperinyloxy, free radical;

4-amino-2,2′

,6,6′

-tetramethyl-1 -piperinyloxy, free radical;

4-hydroxy-2,2′

,6,6′

-tetramethyl-piperidene-1-oxy, free radical;

4-carboxy-2,2′

, 6,6′

-tetramethyl-1-piperinyloxy, free radical;

2,2′

,3,4,5,5′

-hexamethyl-3-imidazolinium-1-yloxy methyl sulfate, free radical;

16-doxyl-stearic acid, free radical;

superoxide dismutase mimic; and

analogs, homologues, congeners, derivatives, salts and combinations thereof.

15. The polymer of claim 13, wherein the free radical scavenger comprises a component selected from a group consisting of TEMPO and any analogs, homologues, congeners, derivatives, salts or combinations thereof.

16. The polymer of claim 13, wherein the nitric oxide donor comprises a component selected from the group consisting of S-nitrosothiols, nitrites, N-oxo-N-nitrosamines, substrates of nitric oxide synthase, diazenium diolates and any analogs, homologues, congeners, derivatives, salts and combinations thereof.

17. The polymer of claim 1, wherein L₁ or L₂ comprises a component selected from a group consisting of ethers, amides, esters, anhydrides, orthoesters, all-aromatic carbonates, acetals, ketals, urethanes, ureas, glycosides, disulfides, siloxanes, and combinations thereof.

18. A medical article comprising the polymer of claim 1.

19. The medical article of claim 18 which is a stent.

20. A method of treating a disorder in a patient comprising implanting in the patient the medical device of claim 19, 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.