Heparin barrier coating for controlled drug release

• US 8,182,527 B2
• Filed: 06/21/2004
• Issued: 05/22/2012
• Est. Priority Date: 05/07/2001
• Status: Active Grant

• Current Assignee: Wyeth (Pfizer Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.), Wyeth (Pfizer Inc.)
• Inventors: Narayanan, Pallassana V., Papandreou, George, Llanos, Gerard H.
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): Stroud, Jonathan R
• Application Number:
  US10/872,990
• Publication Number:
  US 20050004663A1
• Time in Patent Office: 2,892 Days
• Field of Search: None
• US Class Current: 623/1.46
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/115 Staplers for performing anastomosis in a single operation
• CPC Class Codes: A61B 2017/06028 by means of a cylindrical longitudinal blind bore machined at the suture-receiving end of the needle, e.g. opposite to needle tip
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• 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 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2310/0097 Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/436 the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
• CPC Class Codes: A61K 31/727 Heparin; Heparan
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61L 27/34 Macromolecular materials
• 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: C08L 27/12 containing fluorine atoms

Abstract

Medical devices, and in particular implantable medical devices, may be coated to minimize or substantially eliminate a biological organism'"'"'s reaction to the introduction of the medical device to the organism. The medical devices may be coated with any number of biocompatible materials. Therapeutic drugs, agents or compounds may be mixed with the biocompatible materials and affixed to at least a portion of the medical device. In addition, various polymer combinations as well as other therapeutic agents may be utilized to control the elution rates of the therapeutic drugs, agents and/or compounds from the implantable medical devices.

Claims

1. An implantable intraluminal device comprising:

a stent having a substantially tubular body defining a luminal surface and an abluminal surface;

a coating including a polymeric matrix and at least one therapeutic agent affixed to at least one of the luminal and abluminal surfaces, the at least one therapeutic agent comprising sirolimus configured for treating restenosis and inflammation associated with vascular disease, the polymeric matrix comprising PVDF/HFP in a 60/40 weight ratio and wherein the polymeric matrix comprises 64 percent by weight of the coating and the therapeutic agent comprises 36 percent by weight of the coating; and

a diffusion barrier affixed to the coating and configured to control the elution rate of the sirolimus, the diffusion barrier including a layered complex of heparin, polyethylenimine and dextran, the heparin configured for function both as a diffusion barrier and a means to inhibit coagulation, the diffusion barrier comprises multiple layers of polyethylenimine and dextran and wherein polyethylenimine is the outermost layer to which aldehyde-end terminated heparin is immobilized.

2. The implantable intraluminal device according to claim 1, wherein the stent comprises stainless steel.

3. The implantable intraluminal device according to claim 1, wherein the stent comprises a nickel-titanium alloy.

4. The implantable intraluminal device according to claim 1, wherein the stent comprises a cobalt-chromium alloy.

5. The implantable intraluminal device according to claim 1, wherein the diffusion barrier has a thickness in the range from about fifty angstroms to about ten microns.