Stent coating for eluting medication

• US 8,048,151 B2
• Filed: 10/22/2009
• Issued: 11/01/2011
• Est. Priority Date: 01/28/2005
• Status: Expired due to Fees

• Current Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Original Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Inventors: Frysz, Christine A., O'Brien, Robert C.
• Primary Examiner(s): Sweet; Thomas J
• Assistant Examiner(s): STEWART, JASON-DENNIS NEILKEN
• Application Number:
  US12/603,973
• Publication Number:
  US 20100042204A1
• Time in Patent Office: 740 Days
• Field of Search: 623/1.44, 623/1.42, 623/1.15, 623/1.46, 427 21- 231
• US Class Current: 623/1.44
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61L 2300/108 Elemental carbon, e.g. charcoal
• CPC Class Codes: A61L 31/084 Carbon; Graphite
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: Y10T 29/49885 with coating before or during assembling

Abstract

A vascular stent comprising a drug-eluting outer layer of a porous sputtered columnar metal having each column capped with a biocompatible carbon-containing material is described. This is done by placing the stent over a close-fitting mandrel and rotating the assembly in a sputter flux. The result is a coating that is evenly distributed over the outward-facing side of the stent'"'"'s wire mesh while preventing the sputtered columnar coating from reaching the inward facing side where a smooth hemocompatible surface is required. The stent is then removed from the mandrel, exposing all surfaces, and finally coated with a layer of carbon such as amorphous carbon or diamond-like carbon. The carbonaceous coating enhances biocompatibility without preventing elutriation of a therapeutic drug provided in the porosity formed between the columnar structures. The result is a stent that is adapted to both the hemodynamic and the immune response requirements of its vascular environment.

Claims

1. A stent for insertion and expansion in a vasculature to support its adjacent vasculature region, the stent comprising:

a) a plurality of wires forming an elongated and selectively expandable and constrictable hollow tube, each wire providing a substrate having a cross-section comprising an outside-facing surface portion and an inside-facing surface portion facing a lumen formed by the hollow tube, wherein in an expanded condition, the lumen formed by the hollow tube has a diameter that is greater than when in the constricted condition such that in the expanded condition at least the outside-facing surface portions of the plurality of substrate wires are subjected to both tension forces (+σ

e) and compression forces (−

σ

e) within an elastic limit of the wires;

b) and intermediate coating comprising a plurality of columnar structures, each of the columns having a sidewall extending between a proximal end adhered to the substrate wire and a distal end spaced therefrom, wherein the intermediate coating is characterized as having been adhered to the outside-facing surface portion of at least some of the substrate wires when they were in the expanded condition to thereby provide the intermediate columnar coating on the outside-facing surface portion of the substrate wires in a zero stress state within the elastic limits of the wires with the sidewalls of immediately adjacent columns not contacting each other to thereby provide an area of the substrate wire between adjacent columns that is not contacted by the intermediate coating serving as porosity between the columns and wherein when the hollow tube is in a constricted condition, the intermediate columnar coating on the outside-facing portion of the substrate wires is in a tension condition;

c) a cap of a carbon-containing material provided on the distal end of each of the plurality of columnar structures; and

d) wherein the porosity provided between each of the plurality of columnar structures is adapted for receiving an elutable material therein.

2. The stent of claim 1 wherein the carbon-containing material provides a thin film on the inside-facing surface portion of the wire substrate.

3. The stent of claim 1 wherein the intermediate coating is selected from the group consisting of carbides, oxides, nitrides, oxynitrides, and carbonitrides of titanium, boron, aluminum, calcium, gold, hafnium, iridium, molybdenum, niobium, platinum, rhenium, ruthenium, silicon, silver, tantalum, titanium, tungsten, yttrium, zirconium.

4. The stent of claim 1 wherein the carbon-containing coating is selected from an amorphous carbon and a diamond-like carbon.

5. The stent of claim 1 wherein the intermediate coating is adhered to the substrate and the carbon-containing coating is provided as the cap on the distal end of each of the plurality of columnar structures by one of the deposition techniques selected from the group consisting of sputtering, chemical vapor deposition, pulsed laser deposition, reactive evaporation, and as a thermal spray.

6. The stent of claim 1 wherein the plurality of columnar structures comprising the intermediate coating each have a length of about 0.1 μ

m to about 20 μ

m.

7. The stent of claim 1 wherein the carbon-containing coating has a thickness of about 0.05 μ

m to about 2.0 μ

m.

8. The stent of claim 1 wherein the wires are of a material selected from the group consisting of platinum, Nitinol, and medical grade 316L stainless steel containing about 16% nickel.