Coated stent

• US 7,622,135 B2
• Filed: 05/27/2003
• Issued: 11/24/2009
• Est. Priority Date: 10/22/2001
• Status: Expired due to Fees

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Ev3 Peripheral Inc. (Medtronic Plc)
• Inventors: Pathak, Chandrashekhar, Akella, Rama, Ranieri, John
• Primary Examiner(s): Azpuru; Carlos A
• Application Number:
  US10/446,916
• Publication Number:
  US 20060165752A1
• Time in Patent Office: 2,373 Days
• Field of Search: None
• US Class Current: 424/426
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• 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 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 2/16 using chemical substances
• CPC Class Codes: A61L 2/28 Devices for testing the effectiveness or completeness of sterilisation, e.g. indicators which change colour apparatus involving enzymes or microorganisms C12M1/34; methods involving enzymes or microorganisms C12Q1/00
• 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 2300/434 of enzymes
• 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 2300/802 Additives, excipients, e.g. cyclodextrins, fatty acids, surfactants
• CPC Class Codes: A61L 2420/04 Coatings containing a composite material such as inorganic/organic, i.e. material comprising different phases
• CPC Class Codes: A61L 31/048 obtained by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/049 Rubbers
• CPC Class Codes: A61L 31/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/08 Materials for coatings
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/125 having a macromolecular matrix
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

Stents with coatings comprising a combination of a restenosis inhibitor comprising an HMG-CoA reductase inhibitor and a carrier. Also provided are methods of coating stents with a combination of an HMG-CoA reductase inhibitor and a carrier. A preferred example of a restenosis inhibitor is cerivastatin. The stent coatings have been shown to release restenosis inhibitors in their active forms.

Claims

1. A coated stent comprising:

a coating composition comprising an HMG-CoA reductase inhibitor in an effective amount, of about 1 to 50 wt.-%, and a polymeric carrier component;

wherein the polymeric carrier component comprises a polymer selected from polycaprolactone, ethylene-vinyl acetate polymer, and a two-part silicone rubber,

wherein the HMG-CoA reductase inhibitor is selected from the group consisting of cerivastatin, fluvastatin, simvastatin, lovastatin, atorvastatin, pravastatin and mixtures thereof, and

wherein the HMG-CoA reductase inhibitor is released from the coated stent at a rate of >

20 μ

g/ml per day.

2. The coated stent of claim 1, further comprising a catheter wherein the catheter and the coated stent can be coupled to form a treatment assembly.

3. The coated stent of claim 1 wherein the coating composition comprises about equal parts by weight of the HMG-CoA reductase inhibitor and the first polymeric carrier component.

4. The coated stent of claim 1 further comprises a rapamycin compound.

5. The coated stent of claim 1 which further comprises one or more bioactive compounds are selected from the group consisting of paclitaxel, actinomycin D, rapamycin, and mixtures thereof.

6. The coated stent of claim 1 which further comprises one or more bioactive compounds are selected from the group consisting of analogs of paclitaxel, actinomycin D, rapamycin, and mixtures thereof.