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EP2076210A2 - Enrobages de dispositifs médicaux et stents enrobés - Google Patents

Enrobages de dispositifs médicaux et stents enrobés

Info

Publication number
EP2076210A2
EP2076210A2 EP07868551A EP07868551A EP2076210A2 EP 2076210 A2 EP2076210 A2 EP 2076210A2 EP 07868551 A EP07868551 A EP 07868551A EP 07868551 A EP07868551 A EP 07868551A EP 2076210 A2 EP2076210 A2 EP 2076210A2
Authority
EP
European Patent Office
Prior art keywords
stent
medical device
coating
coated stents
vessel
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.)
Withdrawn
Application number
EP07868551A
Other languages
German (de)
English (en)
Inventor
Paul Zamecnik
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.)
Individual
Original Assignee
Individual
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 Individual filed Critical Individual
Publication of EP2076210A2 publication Critical patent/EP2076210A2/fr
Withdrawn legal-status Critical Current

Links

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
    • A61L31/14—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
    • 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
    • A61L33/00—Antithrombogenic treatment of surgical articles, e.g. sutures, catheters, prostheses, or of articles for the manipulation or conditioning of blood; Materials for such treatment
    • A61L33/0005—Use of materials characterised by their function or physical properties
    • A61L33/0011—Anticoagulant, e.g. heparin, platelet aggregation inhibitor, fibrinolytic agent, other than enzymes, attached to the substrate
    • A61L33/0041—Anticoagulant, e.g. heparin, platelet aggregation inhibitor, fibrinolytic agent, other than enzymes, attached to the substrate characterised by the choice of an antithrombatic agent other than heparin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
    • 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
    • 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
    • A61L2300/42—Anti-thrombotic agents, anticoagulants, anti-platelet agents

Definitions

  • the invention relates to a medical device, e.g., a stent having drugs, agents or compounds affixed thereto to minimize a biological organism's reaction to the introduction of the medical device into the organism.
  • a medical device e.g., a stent having drugs, agents or compounds affixed thereto to minimize a biological organism's reaction to the introduction of the medical device into the organism.
  • a stent One of the many implantable medical devices used in the treatment of vascular disease is a stent.
  • the stent is designed to prevent collapse of a vessel that has been weakened or damaged by angioplasty. Insertion of stents has been shown to prevent harmful remodeling of the vessel while healing of the vessel proceeds over several months after angioplasty.
  • Known stent designs include monofilament wire coil stents, welded metal cages and thin- walled metal cylinders with axial slots formed around the circumference.
  • Known construction materials for use in stents include polymers, organic fabrics and biocompatible metals, such as stainless steel, silver, gold, tantalum, titanium, and shape memory alloys such as Nitinol.
  • Vascular stents are typically introduced percutaneously and transported intraluminally to a desired location within the vessel.
  • the stent is then expanded within the vessel either mechanically, such as by the expansion of a balloon within the stent, or self-expanding by releasing stored energy upon actuation within the vessel.
  • drugs or agents have been utilized to coat the stent or to otherwise be diffusably released by the stent.
  • heparin coating of the stent has been shown to reduce restenosis.
  • Other agents having anti-proliferative activity have been used, such as paclitataxel and rapamycin.
  • These and other agents have been incorporated into bioabsorbable or biodegradable polymers as a coating on the stent, or have been applied to the surface of the stent through dip, spray, or spin coating processes, or by electrostatic ab luminal coating.
  • many of the drugs or agents used for this purpose have their own associated toxicities and may therefore be less than optimally suitable.
  • a compound used to render a deployed stent less subject to restenosis should be sufficiently active to produce a therapeutic dose for an extended period of time, should not be toxic to the regrowth of endothelial cells within the vessel lumen, and should function to prevent blood clot formation within the stent.
  • the compound diadenosine 5', 5'", P 1 , P 4 tetraphosphate was first discovered by Moffatt, Can. J. Chem. 42: 599 (1964) as a minor by-product of the chemical synthesis of adenosine triphosphate (ATP). It was subsequently shown by Zamecnik et al., Biochem. Biophys. Res. Comm. 24: 91-97 (1966) to be present as the back reaction product in amino acid activation, the first step in protein synthesis, and to be a ubiquitous component of eukaryotic and prokaryotic cells. Flodgaard and Klenow, Biochem. J. 208: 737 (1982) discovered that platelets have a high content of Ap 4 A in their dense granules.
  • the invention provides medical devices coated with Ap 4 A and/or Ap 4 A analogs, either alone or in combination with other medicaments.
  • the medical devices according to the invention are expected to prevent restenosis and thrombus formation associated with some drug coated stents.
  • the invention provides medical devices coated with Ap 4 A and/or Ap 4 A analogs, either alone or in combination with other medicaments.
  • the medical devices according to the invention are expected to prevent restenosis and thrombus formation associated with some drug coated stents.
  • the invention provides a vascular stent that is coated with Ap 4 A and/or Ap 4 A analogs.
  • stent is given its conventional meaning within the medical devices art and includes both mechanically expandable and self-expandable stents.
  • the term "coated with” means that the stent is associated with Ap 4 A or a Ap 4 A analog in a manner that allows the Ap 4 A or an Ap 4 A analog to locally contact platelets and other cell types that are in contact with, or in the immediate vicinity of the stent.
  • Such associations include covalent attachment of the molecule to the stent. Such covalent attachment may be reversible or irreversible. In preferred embodiments, reversible attachment to the stent may be via a chemical linkage that is labile in vivo. Such labile linkages include ester linkages, including phosphoester linkages, as well as amide or peptide linkages.
  • US2006/021780 IAl discloses a stent having an engineered abluminal surface that is engineered to have a material comprising a mixture of a polymer and a drug extending from the abluminal surface by depositing microdrops of the mixture onto the abluminal surface of the stent.
  • US2006/0229706A1 discloses a stent having a drug-release coating of a thickness of 3-30 microns and composed of 20-80 weight percent polymer substrate and 20-80 weight percent active compound, where the coating is effective to release an amount of the active compound to prevent restenosis at the site of the stent.
  • the stent body is metallic and the polymer is selected from polymethylacrylate, ethylene vinyl alcohol, poly-lactide polymers (especially poly-dl- lactide), ⁇ -caprolactone, ethyl vinyl acetate, polyvinyl alcohol and polyethylene oxide.
  • US2006/0222756A1 discloses a method for coating a stent with a therapeutic agent comprising the steps of creating a polymer utilizing vinylidene fluoride and hexafluoropropylene in a batch emulsion polymerization process, priming the stent with the polymer utilizing a dip coating process, creating a polymer and therapeutic agent mixture, applying the polymer and therapeutic agent mixture on the primer layer utilizing a spin coating process, and drying the coated stent in a vacuum oven for approximately sixteen hours at a temperature in the range of fifty to sixty degrees centigrade.
  • US2006/021643 IAl discloses a method for electrostatically coating the ab luminal surfaces of a stent that is crimp-mounted on a balloon catheter comprising threading a wire through a lumen of the stent-balloon assembly and applying a charge to the wire, while the stent is grounded, and applying an electrostatic spray coating to the stent-balloon assembly.
  • a charge can be applied to the stent that is opposite to the charge applied to the wire.
  • the wire is the guidewire for the catheter which is threaded through the guidewire lumen.
  • the delivery of an active agent from the coating to the vascular wall is through diffusion of the active agent through either a bulk polymer or through pores that are created in the polymer structure, or by erosion of a biodegradable coating.
  • Ap 4 A refers to diadenosine 5', 5'", P 1 , P 4 tetraphosphate, which has the structural formula (I):
  • an "Ap 4 A analog” is a compound having antiplatelet activity similar to or greater than Ap 4 A , and a structural formula derived from (I), wherein one or more atom is replaced by another atom or atoms or one or more chemical bond.
  • one or more bridging oxygen atoms in formula (I) may be replaced by a methylene, halomethylene, or dihalomethylene group.
  • One or more non-bridging oxygen atom may be replaced by a sulfur atom, by a lower alkyl group (including a methyl group), by an O-lower alkyl group (including an O-methyl group), by an amino or amido group, or by a boronate group.
  • One or more phosphate group may be replaced by a peptide linkage.
  • One or both hydroxyl moieties on either or both ribosyl groups may be replaced by hydrogen, or by halo or alkoxy groups, or may be in a locked 2 ',4' ring configuration.
  • One adenine moiety may be missing or replaced by purine or another purine analog, or by pyrimidine or another pyrimidine analog.
  • One adenosyl moiety may be missing.
  • Similar to means at least about one tenth the anti-platelet activity OfAp 4 A in a conventional anti-platelet assay, e.g., as taught in Chan et al., Proc. Natl. Acad. Sci. USA 94: 4034-4039 (1997).
  • Ap 4 A or an Ap 4 A analog should be present on the stent or in the stent coating in an amount effective to prevent platelet aggregation on a surface of the stent or within the stent.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Surgery (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Materials Engineering (AREA)
  • Biomedical Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Molecular Biology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Materials For Medical Uses (AREA)

Abstract

L'invention concerne un dispositif médical enrobé d'Ap4A et/ou d'un analogue d'Ap4A. Dans un mode de réalisation préféré, le dispositif médical est un stent vasculaire.
EP07868551A 2006-10-24 2007-10-24 Enrobages de dispositifs médicaux et stents enrobés Withdrawn EP2076210A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US86264006P 2006-10-24 2006-10-24
PCT/US2007/082323 WO2008063806A2 (fr) 2006-10-24 2007-10-24 Enrobages de dispositifs médicaux et stents enrobés

Publications (1)

Publication Number Publication Date
EP2076210A2 true EP2076210A2 (fr) 2009-07-08

Family

ID=39430426

Family Applications (1)

Application Number Title Priority Date Filing Date
EP07868551A Withdrawn EP2076210A2 (fr) 2006-10-24 2007-10-24 Enrobages de dispositifs médicaux et stents enrobés

Country Status (4)

Country Link
EP (1) EP2076210A2 (fr)
JP (1) JP2010507466A (fr)
CA (1) CA2666689A1 (fr)
WO (1) WO2008063806A2 (fr)

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5049550A (en) * 1987-11-05 1991-09-17 Worcester Foundation For Experimental Biology Diadenosine 5', 5'"-p1, p4,-tetraphosphate analogs as antithrombotic agents
JP2783880B2 (ja) * 1989-11-24 1998-08-06 富士レビオ株式会社 心臓病治療剤
US7452870B2 (en) * 2000-08-21 2008-11-18 Inspire Pharmaceuticals, Inc. Drug-eluting stents coated with P2Y12 receptor antagonist compound

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO2008063806A3 *

Also Published As

Publication number Publication date
CA2666689A1 (fr) 2008-05-29
JP2010507466A (ja) 2010-03-11
WO2008063806A2 (fr) 2008-05-29
WO2008063806A3 (fr) 2008-11-06

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