Endoprosthesis with coatings

• US 7,981,150 B2
• Filed: 09/24/2007
• Issued: 07/19/2011
• Est. Priority Date: 11/09/2006
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Xu, Yixin, Weber, Jan, Scheuermann, Torsten
• Primary Examiner(s): Stewart; Alvin J.
• Application Number:
  US11/860,253
• Publication Number:
  US 20080147177A1
• Time in Patent Office: 1,394 Days
• Field of Search: 623/23.72, 623/23.73, 623/23.74, 623/23.75, 623/23.76
• US Class Current: 623/1.39
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61L 2300/00 Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
• CPC Class Codes: A61L 2400/12 Nanosized materials, e.g. nanofibres, nanoparticles, nanowires, nanotubes; Nanostructured surfaces
• CPC Class Codes: A61L 27/30 Inorganic materials
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 31/082 Inorganic materials
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence

Abstract

An endoprosthesis such as a coronary stent includes a polymeric reservoir of drug and an over coating formed of ceramic or metal for controlling elution of drag from the reservoir.

Claims

1. An endoprosthesis, comprising:

a first coating comprising a polymer, and

a second coating over the first coating formed of a porous ceramic,

wherein the porous ceramic has a smooth globular morphology to enhance endothelial cell growing over the second coating, the globular morphology having a series of shallow globular features and the globular features having a local maxima width of about 100 nm or less and a peak height of about 50 nm or less.

2. The endoprosthesis of claim 1, wherein the polymer includes a drug.

3. The endoprosthesis of claim 1, wherein the ceramic iridium oxide, titanium oxide, tantalum oxide, or niobium oxide.

4. The endoprosthesis of claim 1, wherein the first coating has a plurality of depressions.

5. The endoprosthesis of claim 1, wherein the second coating has pores with a pore diameter of about 1 nm to about 20 nm.

6. The endoprosthesis of claim 1, wherein the thickness of the second coating is about 10 to about 500 nm.

7. The endoprosthesis of claim 1, wherein the thickness of the first coating is about 0.1 to about 10 micron.

8. The endoprosthesis of claim 1, wherein the first coating contacts a surface of an endoprosthesis body.

9. The endoprosthesis of claim 8, wherein the endoprosthesis body is formed of a metal.

10. The endoprosthesis of claim 8, wherein the endoprosthesis body is formed of a polymer.

11. The endoprosthesis of claim 10, wherein the polymer is a bioerodible polymer.

12. The endoprosthesis of claim 10, wherein the polymer is a biostable polymer.

13. The endoprosthesis of claim 1, further comprising a third coating under the first coating, the third coating formed of a ceramic having a high roughness defined grain morphology.

14. The endoprosthesis of claim 1, wherein the globular morphology has a developed interfacial area ratio of between 8 and 15.

15. A method of forming an endoprosthesis, comprising:

forming a polymer coating on the endoprosthesis wherein the polymer coating comprises a drug, and

forming a layer of porous ceramic or metal over the drug-containing polymer coating, wherein the porous ceramic has a smooth globular morphology to enhance endothelial cell growing over the porous ceramic, the globular morphology having a series of shallow globular features and the globular features having a local maxima width of about 100 nm or less and a peak height of about 50 nm or less.

16. The method of claim 15, comprising forming the polymer coating by spraying a solution of a polymer and a drug to a surface of an endoprosthesis body.

17. The method of claim 15, comprising introducing the drug by coating, dipping, or spraying.

18. The method of claim 15, comprising forming the polymer coating by introducing a polymer by dipping, spraying, brushing, pressing, laminating, or pulsed laser deposition.

19. The method of claim 15 comprising introducing the drug by pulsed laser deposition.

20. The method of claim 15 comprising forming the porous ceramic layer by pulsed laser deposition.

21. The method of claim 15, further comprising forming depressions in the polymer coating by laser irradiation.

22. An endoprosthesis, comprising:

a first coating comprising a polymer;

a second coating over the first coating, the second coating being formed of a porous ceramic having a smooth globular morphology, the globular morphology having a series of shallow globular features and the globular features having a local maxima width of about 100 nm or less and a peak height of about 50 nm or less, and

a third coating under the first coating, the third coating being formed of a ceramic having a high roughness defined grain morphology.