Claims for Patent: 8,309,112

Summary for Patent: 8,309,112

Title:	Coatings for implantable medical devices comprising hydrophilic substances and methods for fabricating the same
Abstract:	A segmented polyurethane and an amphiphilic random or block copolymer are disclosed. The segmented polyurethane and the amphiphilic random or block copolymer can be used for fabricating a coating for an implantable medical device such as a stent.
Inventor(s):	Glauser; Thierry (Redwood City, CA), Kwok; Connie S. (Santa Clara, CA), Claude; Charles D. (Sunnyvale, CA), Michal; Eugene T. (San Francisco, CA), Tang; Yiwen (San Jose, CA), Astafieva; Irina (Palo Alto, CA), Whatley; John (San Francisco, CA), Pacetti; Stephen D. (San Jose, CA), Shah; Ashok (San Jose, CA)
Assignee:	Advanced Cardiovascular Systems, Inc. (Santa Clara, CA)
Application Number:	10/746,483
Patent Claims:	1. A medical article, comprising an implantable substrate and a coating disposed at least on a portion of the substrate, the coating including an amphiphilic copolymer comprising at least one hydrophobic moiety and at least one hydrophilic moiety, wherein at least one hydrophilic moiety comprises 2-acrylamido-2-methyl-1-propanesulfonic acid, 3-sulfopropyl acrylate, 3-sulfopropyl methacrylate, or 3-allyloxy-2-hydroxypropanesulfonic acid, and wherein the coating includes a therapeutic agent incorporated or dispersed in the coating in a mass ratio of the therapeutic agent to the amphiphilic copolymer between about 1:10 and about 1:3. 2. The medical article of claim 1, wherein the amphiphilic copolymer comprises an acrylic copolymer. 3. The medical article of claim 2, wherein the acrylic copolymer is a block copolymer or a random copolymer. 4. The medical article of claim 3, wherein the block copolymer is an ABA block copolymer or an AB block-copolymer. 5. The medical article of claim 1, wherein the hydrophobic moiety is selected from a group consisting of methyl methacrylate, ethyl methacrylate, n-butyl methacrylate, and lauryl methacrylate. 6. The medical article of claim 1, wherein the amphiphilic copolymer is a product of living free radical copolymerization of plurality of monomers with initiation-transfer agent termination of the living macro-chains. 7. The medical article of claim 1, wherein the therapeutic agent is selected from a group consisting of cyclic-RGD peptide, poly(L-arginine), poly(D-arginine), poly(D,L-arginine), poly(L-lysine), poly(D-lysine), poly(.delta.-guanidino-.alpha.-aminobutyric acid), a racemic mixture of poly(L-arginine) with poly(D-arginine), elastin mimetic polypeptides, and blends thereof. 8. The medical article of claim 1, wherein the coating comprises a small-molecule water soluble drug. 9. A medical article, comprising an implantable substrate and a coating disposed at least on a portion of the substrate, the coating including an amphiphilic copolymer comprising at least one hydrophobic moiety and at least one hydrophilic moiety, wherein the amphiphilic copolymer has a formula ##STR00026## wherein (a) each of m, n, and p is, independently, an integer, wherein m >0, n >0, and p >0; (b) X, Y, and Z each is independently hydrogen or an alkyl group; and (c) R, R.sub.1, R.sub.2 is independently a straight-chained or branched substituted or unsubstituted alkyl group, or substituted or unsubstituted aryl group, wherein at least one of R and R.sub.2 is 3-sulfopropyl; wherein the coating further includes a therapeutic agent incorporated or dispersed in the coating. 10. The medical article of claim 9, wherein the block copolymer is an ABA block copolymer or an AB block-copolymer. 11. The medical article of claim 9, wherein the amphiphilic copolymer comprises PSPMA-PBMA-PSPMA, or PSPMA-PBMA, wherein PSPMA is poly 3-sulfopropyl methacrylate, PBMA is poly(butylmethacrylate). 12. The medical article of claim 9, wherein the therapeutic agent is selected from a group consisting of cyclic-RGD peptide, poly(L-arginine), poly(D-arginine), poly(D,L-arginine), poly(L-lysine), poly(D-lysine), poly(.delta.-guanidino-.alpha.-aminobutyric acid), a racemic mixture of poly(L-arginine) with poly(D-arginine), elastin mimetic polypeptides, and blends thereof.