Local vascular delivery of mycophenolic acid in combination with rapamycin to prevent restenosis following vascular injury

• US 20050158360A1
• Filed: 01/20/2004
• Published: 07/21/2005
• Est. Priority Date: 01/20/2004
• Status: Active Grant

• Current Assignee: Wyeth (Pfizer Inc.)
• Original Assignee: Wyeth (Pfizer Inc.)
• Inventors: Zhao, Jonathon Z., Falotico, Robert, Parry, Tom Jay
• Granted Patent: US 7,303,758 B2
• Time in Patent Office: Days
• US Class Current: 424/424
• CPC Class Codes: A61L 2300/21 Acids
• 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 2420/08 Coatings comprising two or more layers
• 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: A61P 41/00 Drugs used in surgical methods, e.g. surgery adjuvants for preventing adhesion or for vitreum substitution
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 7/02 Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
• CPC Class Codes: A61P 9/10 for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
• CPC Class Codes: A61P 9/14 Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers
• CPC Class Codes: C08L 27/16 Homopolymers or copolymers or vinylidene fluoride
• CPC Class Codes: C08L 27/20 Homopolymers or copolymers of hexafluoropropene

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. These therapeutic drugs, agents or compounds may also further reduce a biological organism'"'"'s reaction to the introduction of the medical device to the organism. In addition, these therapeutic drugs, agents and/or compounds may be utilized to promote healing, including the formation of blood clots. Also, the devices may be modified to promote endothelialization. Various materials and coating methodologies may be utilized to maintain the drugs, agents or compounds on the medical device until delivered and positioned. In addition, the devices utilized to deliver the implantable medical devices may be modified to reduce the potential for damaging the implantable medical device during deployment. Medical devices include stents, grafts, anastomotic devices, perivascular wraps, sutures and staples. In addition, various polymer combinations may be utilized to control the elution rates of the therapeutic drugs, agents and/or compounds from the implantable medical devices.

Claims

1. A medical device comprising:

an implantable structure;

a basecoat matrix, including a combination of rapamycin and mycophenolic acid, in therapeutic dosages, incorporated in a first polymeric material, the basecoat matrix being affixed to the surface of the implantable medical device; and

a topcoat, including a second polymeric material, affixed to the basecoat matrix for controlling the elution rate of the rapamycin and mycophenolic acid.

2. The medical device according to claim 1, wherein the implantable structure comprises a stent.

3. The medical device according to claim 1, wherein the implantable structure comprises a stent-graft.

4. The medical device according to claim 1, wherein the implantable structure comprises an anastomosis device.

5. The medical device according to claim 1, wherein the second polymeric material is incompatible with the first polymeric material, thereby creating both a physical and chemical barrier to the elution of the rapamycin and mycophenolic acid.

6. The medical device according to claim 5, wherein the first polymeric material comprises a fluoropolymer.

7. The medical device according to claim 5, wherein the second polymeric material comprises an acrylic.

8. A method for treating restenosis comprising the local administration of therapeutic dosages of rapamycin and mycophenolic acid from a two-layered polymeric matrix including incompatible polymers.

9. A medical device comprising:

an implantable structure;

a basecoat matrix, including mycophenolic acid, in therapeutic dosages, incorporated in a first polymeric matrix, the basecoat matrix being affixed to the surface of the implantable medical device; and

a topcoat, including a second polymeric material and rapamycin, in therapeutic dosages, affixed to the basecoat matrix for controlling the elution rate of the rapamycin and the mycophenolic acid.