Liquid and low melting coatings for stents

• US 8,449,905 B2
• Filed: 09/28/2010
• Issued: 05/28/2013
• Est. Priority Date: 10/22/2001
• Status: Expired due to Fees

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: Pathak, Chandrashekhar
• Primary Examiner(s): AZPURU, CARLOS A
• Application Number:
  US12/891,953
• Publication Number:
  US 20110064868A1
• Time in Patent Office: 973 Days
• Field of Search: None
• US Class Current: 424/425
• 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 method of coating a stent comprising:

providing a stent,

providing a coating composition comprising a biologically active component and a non-polymeric biodegradable carrier having a melting point of about 50°

C. or less and a viscosity of from about 0.1 to about 15000 cP, and

applying the coating composition to the stent.

2. The method of claim 1, further comprising the step of expanding the stent to an increased diameter before applying the coating composition to the stent.

3. The method of claim 1, wherein the step of applying the coating composition comprises spraying or painting the coating composition onto the stent, or immersing the stent in the coating composition.

4. The method of claim 1, wherein the biodegradable carrier has a melting point of from about 35°

C. to about 45°

C.

5. The method of claim 1, wherein the biodegradable carrier is a liquid at body temperature.

6. The method of claim 1, wherein the biodegradable carrier is hydrophobic.

7. The method of claim 1, wherein the biologically active component comprises a HMG-CoA reductase inhibitor present in an amount from about 1 wt % to about 50 wt %, based on the total weight of the coating composition.

8. The method of claim 7, wherein the HMG-CoA reductase inhibitor is selected from cerivastatin, atorvastatin, simvastatin, fluvastatin, lovastatin, and pravastatin.

9. The method of claim 7, wherein the HMG-CoA reductase inhibitor is cerivastatin.

10. The method of claim 1, wherein the biologically active component is capable of inhibiting restenosis.

11. The method of claim 10, wherein the biologically active component is selected from paclitaxes and rapamycin.

12. The method of claim 1, wherein the biologically active component is selected from paclitaxel, actinomycin D, rapamycin, cerivastatin, fluvastatin, simvastatin, lovastatin, atorvastatin, and pravastatin, and combinations thereof.