Coating For Implantable Devices And A Method Of Forming The Same

• US 20120185034A1
• Filed: 03/22/2012
• Published: 07/19/2012
• Est. Priority Date: 12/28/2000
• Status: Active Grant

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Hossainy, Syed F.A., Pacetti, Stephen D., Fong, Keith E., Bhat, Vinayak, Sanders Millare, Deborra, Guruwaiya, Judy A., Mirzaee, Daryush, Mandrusov, Evgenia
• Granted Patent: US 8,652,501 B2
• Time in Patent Office: Days
• US Class Current: 623/1.15
• 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 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 2300/608 having two or more layers
• CPC Class Codes: A61L 2420/02 Methods for coating medical devices
• CPC Class Codes: A61L 2420/08 Coatings comprising two or more layers
• CPC Class Codes: A61L 27/306 Other specific inorganic materials not covered by A61L27/303 - A61L27/32
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• 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: A61L 33/0011 Anticoagulant, e.g. heparin, platelet aggregation inhibitor, fibrinolytic agent, other than enzymes, attached to the substrate
• CPC Class Codes: C08L 29/04 Polyvinyl alcohol; Partially hydrolysed homopolymers or copolymers of esters of unsaturated alcohols with saturated carboxylic acids

Abstract

Coatings for implantable devices or endoluminal prosthesis, such as stents, are provided, including a method of forming the coatings. The coatings can serve as a primer coating for subsequent coatings that can be used for the delivery of an active ingredient or a combination of active ingredients.

Claims

1. An implantable device comprising a coating, the coating comprising:

a reservoir region comprising a polymer and a drug blended with or dispersed in the polymer; and

a primer region free from any drugs located between the reservoir region and the surface of the implantable device, the primer region comprising a material having a high content of hydrogen bonding groups, the material having a high content of hydrogen bonding groups being selected from the group consisting of epoxy polymers cured by polyols and Lewis acid catalysts, epoxy phenolics, epoxy-polysulfides, ethylene vinyl acetate, melamine formaldehydes, polyvinylalcohol-co-vinyl acetate polymers, resorcinol-formaldehydes, urea-formaldehydes, polyvinylbutyral, polyvinylacetate, alkyd polyester resins, acrylic acid modified ethylene vinyl acetate polymers, methacrylic acid modified ethylene vinyl acetate polymers, acrylic acid modified ethylene acrylate polymers, methacrylic acid modified ethylene acrylate polymers, anhydride modified ethylene acrylate copolymers, anhydride modified ethylene vinyl acetate polymers, and combinations thereof.

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

3. The implantable device of claim 1, wherein the surface of the implantable device includes a chromium oxide layer.

4. The implantable device of claim 1, wherein the surface of the implantable device is metallic.

5. The implantable device of claim 1, wherein the reservoir region comprises a combination of polymers.

6. The implantable device of claim 1, wherein the material having a high content of hydrogen bonding groups comprises at least one material selected from the group consisting of epoxy polymers cured by polyols and Lewis acid catalysts, epoxy phenolics, and epoxy-polysulfides.

7. The implantable device of claim 1, wherein the material having a high content of hydrogen bonding groups comprises at least one material selected from the group consisting of ethylene vinyl acetate, polyvinylalcohol-co-vinyl acetate polymers, polyvinylbutyral, polyvinylacetate, and alkyd polyester resins.

8. The implantable device of claim 1, wherein the material having a high content of hydrogen bonding groups comprises at least one material selected from the group consisting of melamine formaldehydes, resorcinol-formaldehydes, and urea-formaldehydes.

9. The implantable device of claim 1, wherein the material having a high content of hydrogen bonding groups comprises at least one material selected from the group consisting of acrylic acid modified ethylene vinyl acetate polymers, methacrylic acid modified ethylene vinyl acetate polymers, acrylic acid modified ethylene acrylate polymers, and methacrylic acid modified ethylene acrylate polymers.

10. The implantable device of claim 1, wherein the material having a high content of hydrogen bonding groups comprises at least one material selected from the group consisting of anhydride modified ethylene acrylate copolymers and anhydride modified ethylene vinyl acetate polymers.

11. A stent comprising a coating, the coating comprising:

a reservoir region comprising a drug; and

a primer region free from any drugs located between the reservoir region and the surface of the stent, the primer region comprising a material having a high content of hydrogen bonding groups, the material having a high content of hydrogen bonding groups being selected from the group consisting of epoxy polymers cured by polyols and Lewis acid catalysts, epoxy phenolics, epoxy-polysulfides, ethylene vinyl acetate, melamine formaldehydes, polyvinylalcohol-co-vinyl acetate polymers, resorcinol-formaldehydes, urea-formaldehydes, polyvinylbutyral, polyvinylacetate, alkyd polyester resins, acrylic acid modified ethylene vinyl acetate polymers, methacrylic acid modified ethylene vinyl acetate polymers, acrylic acid modified ethylene acrylate polymers, methacrylic acid modified ethylene acrylate polymers, anhydride modified ethylene acrylate copolymers, anhydride modified ethylene vinyl acetate polymers, and combinations thereof.

12. The stent of claim 11, wherein the material having a high content of hydrogen bonding groups comprises at least one material selected from the group consisting of epoxy polymers cured by polyols and Lewis acid catalysts, epoxy phenolics, and epoxy-polysulfides.

13. The stent of claim 11, wherein the material having a high content of hydrogen bonding groups comprises at least one material selected from the group consisting of ethylene vinyl acetate, polyvinylalcohol-co-vinyl acetate polymers, polyvinylbutyral, polyvinylacetate, and alkyd polyester resins.

14. The stent of claim 11, wherein the material having a high content of hydrogen bonding groups comprises at least one material selected from the group consisting of melamine formaldehydes, resorcinol-formaldehydes, and urea-formaldehydes.

15. The stent of claim 11, wherein the material having a high content of hydrogen bonding groups comprises at least one material selected from the group consisting of acrylic acid modified ethylene vinyl acetate polymers, methacrylic acid modified ethylene vinyl acetate polymers, acrylic acid modified ethylene acrylate polymers, and methacrylic acid modified ethylene acrylate polymers.

16. The stent of claim 11, wherein the material having a high content of hydrogen bonding groups comprises at least one material selected from the group consisting of anhydride modified ethylene acrylate copolymers and anhydride modified ethylene vinyl acetate polymers.

17. The stent of claim 11, wherein the surface of the stent comprises a chromium oxide layer.

18. The stent of claim 11, wherein the surface of the stent is metallic.