Bioabsorbable coating with tunable hydrophobicity

• US 8,961,589 B2
• Filed: 08/01/2007
• Issued: 02/24/2015
• Est. Priority Date: 08/01/2007
• Status: Expired due to Fees

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Kleiner, Lothar W., Stankus, John, Pham, Nam D., Ngo, Michael H., Maslanka, Bozena Zofia, Hossainy, Syed Faiyaz Ahmed, Trollsas, Mikael, Tang, Yiwen
• Primary Examiner(s): Pagonakis, Anna
• Assistant Examiner(s): PRESTON, REBECCA STRASZHEIM
• Application Number:
  US11/888,807
• Publication Number:
  US 20090036978A1
• Time in Patent Office: 2,764 Days
• Field of Search: None
• US Class Current: 623/1.42
• 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 47/34 Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers A61K47/10 takes precedence
• 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 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61P 37/06 Immunosuppressants, e.g. drugs for graft rejection
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

The present invention relates to implantable medical devices coated with polymer having tunable hydrophobicity and their use in the treatment of vascular diseases.

Claims

1. An implantable medical device, comprising:

a device body;

an optional primer layer disposed over the device body;

a drug reservoir layer disposed over the device body or the primer layer, if opted,

wherein the drug reservoir layer comprises a polymer and a therapeutic agent and further wherein the hydrophobicity of the polymer is matched to that of the therapeutic agent so that the therapeutic agent is miscible with the polymer;

wherein the polymer is

poly(L-lactide-co-ε

-caprolactone) wherein the molar ratio of L-lactide and ε

-caprolactone is from 70;

30 to 50;

50, or

poly(L-lactide-co-trimethylene carbonate) wherein the molar ratio of L-lactide and trimethylene carbonate is 70;

30;

wherein the therapeutic agent is everolimus.

2. The implantable medical device of claim 1, wherein the poly(L-lactide-co-ε

-caprolactone) has an average molecular weight from about 50,000 to about 500,000 Daltons.

3. The implantable medical device of claim 1, wherein the drug reservoir layer has a coating thickness from 1 μ

m to 10 μ

m.

4. The implantable medical device of claim 1, wherein the therapeutic agent to polymer wt/wt ratio is from 1.0:

0.5 to 1.0;

10.0.

5. The implantable medical device of claim 1, wherein the therapeutic agent dose is from 5-200 microgram/cm² to 20-100 microgram/cm².

6. The implantable medical device of claim 1, wherein the device is a stent.

7. A method of treating a vascular disease, wherein the vascular disease is selected from the group consisting of atherosclerosis, restenosis, vulnerable plaque, peripheral vascular disease, and late stent thrombosis, wherein the method of treating comprises:

deploying in the vasculature of a patient in need thereof an implantable medical device of claim 1.