Local administration of a combination of rapamycin and 17 beta-estradiol for the treatment of vulnerable plaque

• US 20050232965A1
• Filed: 04/15/2004
• Published: 10/20/2005
• Est. Priority Date: 04/15/2004
• Status: Abandoned Application

• Current Assignee: Wyeth (Pfizer Inc.)
• Original Assignee: Wyeth (Pfizer Inc.)
• Inventors: Falotico, Robert
• Application Number:
  US10/826,058
• Publication Number:
  US 20050232965A1
• Time in Patent Office: Days
• US Class Current: 424/423
• 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 2220/0066 stapled
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• 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 2300/43 Hormones, e.g. dexamethasone
• CPC Class Codes: A61L 2300/45 Mixtures of two or more drugs, e.g. synergistic mixtures
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system
• 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

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. The drugs, agents, and/or compounds may also be utilized to treat specific diseases, including vulnerable plaque. Therapeutic agents may also be delivered to the region of a disease site. In regional delivery, liquid formulations may be desirable to increase the efficacy and deliverability of the particular drug. 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 for the treatment of atherosclerotic vulnerable plaque comprising:

a stent for maintaining vessel patentcy and providing structural support for a fibrous cap of the vulnerable plaque lesion;

a biocompatible vehicle affixed to at least a portion of the stent; and

a combination of a rapamycin and 17 beta-estradiol, in therapeutic dosages, incorporated into the biocompatible vehicle for treating at least one of the fibrous cap and a lipid core of the vulnerable plaque lesion.

2. The medical device for the treatment of atherosclerotic vulnerable plaque according to claim 1, wherein the stent is balloon expandable.

3. The medical device for the treatment of atherosclerotic vulnerable plaque according to claim 1, wherein the stent is self-expanding.

4. The medical device for the treatment of atherosclerotic vulnerable plaque according to claim 1, wherein the biocompatible vehicle comprises a polymeric coating.

5. The medical device for the treatment of atherosclerotic vulnerable plaque according to claim 1, wherein the rapamycin comprises sirolimus.