CA2493423A1 - Local vascular delivery of mycophenolic acid in combination with rapamycin to prevent restenosis following vascular injury - Google Patents

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

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Publication number
CA2493423A1
CA2493423A1 CA002493423A CA2493423A CA2493423A1 CA 2493423 A1 CA2493423 A1 CA 2493423A1 CA 002493423 A CA002493423 A CA 002493423A CA 2493423 A CA2493423 A CA 2493423A CA 2493423 A1 CA2493423 A1 CA 2493423A1
Authority
CA
Canada
Prior art keywords
medical device
rapamycin
mycophenolic acid
devices
agents
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002493423A
Other languages
French (fr)
Other versions
CA2493423C (en
Inventor
Robert Falotico
Tom Jay Parry
Jonathon Z. Zhao
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Cardinal Health 529 LLC
Original Assignee
Cordis Corporation
Robert Falotico
Tom Jay Parry
Jonathon Z. Zhao
CARDINAL HEALTH SWITZERLAND 515 GmbH
Cardinal Health 529, Llc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Cordis Corporation, Robert Falotico, Tom Jay Parry, Jonathon Z. Zhao, CARDINAL HEALTH SWITZERLAND 515 GmbH, Cardinal Health 529, Llc filed Critical Cordis Corporation
Publication of CA2493423A1 publication Critical patent/CA2493423A1/en
Application granted granted Critical
Publication of CA2493423C publication Critical patent/CA2493423C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/08—Materials for coatings
    • A61L31/10—Macromolecular materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/16—Biologically active materials, e.g. therapeutic substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P41/00—Drugs used in surgical methods, e.g. surgery adjuvants for preventing adhesion or for vitreum substitution
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/14—Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
    • A61L2300/21—Acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/416—Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2420/00—Materials or methods for coatings medical devices
    • A61L2420/08—Coatings comprising two or more layers

Abstract

Medical devices, and in particular implantable medical devices, may be coated to minimize or substantially eliminate a biological organism's reacti on 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 reduc e the potential for damaging the implantable medical device during deployment. Medical devices include stents, grafts, anastomotic devices, perivascul ar 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 (9)

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.
CA2493423A 2004-01-20 2005-01-19 Local vascular delivery of mycophenolic acid in combination with rapamycin to prevent restenosis following vascular injury Active CA2493423C (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US10/761,032 US7303758B2 (en) 2004-01-20 2004-01-20 Local vascular delivery of mycophenolic acid in combination with rapamycin to prevent restenosis following vascular injury
US10/761,032 2004-01-20

Publications (2)

Publication Number Publication Date
CA2493423A1 true CA2493423A1 (en) 2005-07-20
CA2493423C CA2493423C (en) 2011-08-16

Family

ID=34634566

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2493423A Active CA2493423C (en) 2004-01-20 2005-01-19 Local vascular delivery of mycophenolic acid in combination with rapamycin to prevent restenosis following vascular injury

Country Status (4)

Country Link
US (1) US7303758B2 (en)
EP (2) EP1557183A1 (en)
JP (1) JP4781681B2 (en)
CA (1) CA2493423C (en)

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Also Published As

Publication number Publication date
JP2005237951A (en) 2005-09-08
US7303758B2 (en) 2007-12-04
JP4781681B2 (en) 2011-09-28
US20050158360A1 (en) 2005-07-21
EP2286848A2 (en) 2011-02-23
CA2493423C (en) 2011-08-16
EP1557183A1 (en) 2005-07-27
EP2286848A3 (en) 2012-08-29

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