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WO2006061115A1 - Tuteurs intravasculaires delivrant un principe actif - Google Patents

Tuteurs intravasculaires delivrant un principe actif Download PDF

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Publication number
WO2006061115A1
WO2006061115A1 PCT/EP2005/012675 EP2005012675W WO2006061115A1 WO 2006061115 A1 WO2006061115 A1 WO 2006061115A1 EP 2005012675 W EP2005012675 W EP 2005012675W WO 2006061115 A1 WO2006061115 A1 WO 2006061115A1
Authority
WO
WIPO (PCT)
Prior art keywords
stents
stent
angiotensin
active ingredient
drug
Prior art date
Application number
PCT/EP2005/012675
Other languages
German (de)
English (en)
Inventor
Marc Lohrmann
Original Assignee
Bayer Innovation Gmbh
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 Bayer Innovation Gmbh filed Critical Bayer Innovation Gmbh
Publication of WO2006061115A1 publication Critical patent/WO2006061115A1/fr

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
    • 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
    • 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
    • A61L2300/432—Inhibitors, antagonists
    • A61L2300/436—Inhibitors, antagonists of receptors
    • 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
    • A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/606—Coatings

Definitions

  • the present invention relates to angiotensin receptor antagonist-containing stents and to methods of making these stents.
  • Atherosclerosis has two forms of training. On the one hand, it is characterized by deposits on the inside of the arteries, which narrow the vessel clearing and lead to reduced blood flow. In extreme cases, such deposits can completely occlude the vessel over time. Such constrictions can be diagnosed by angiographic methods. In terminology, this is referred to as arteriosclerotic plaque formation or arteriosclerosis.
  • plaques that do not significantly clog an artery, as it is usually detected with angiography. But in the plaques, an inflammatory process occurs, with the formation of a large lipid core, a thin cap and an increasing content of macrophages, foam cells and other cells. With regard to the pathogenic potential that sudden rupture causes myocardial infarction by immediate lumping, these arteriosclerotic foci are referred to as vulnerable plaques.
  • Arteriosclerotic coronary diseases are treated with the usual method of balloon dilatation (percutaneous transluminal coronary angioplasty, PTCA).
  • PTCA percutaneous transluminal coronary angioplasty
  • a balloon catheter is introduced into the narrowed or closed artery, which is then widened by expansion of the balloon and the blood flow is thus restored.
  • the acute, immediately after the PTCA occurring (acute restenosis) or the subsequent, subacute (recurrent stenosis, restenosis) resealing of the blood vessel is a problem that occurs in about 30% of cases.
  • PTA percutaneous transluminal angioplasty
  • peripheral vessels such as the carotid, iliac (ilical), renal (renal), cerebral (cerebral), subclavicular and femopopliteal vessels.
  • the risk of acute restenosis may be reduced by the use of antiplatelet agents.
  • mechanical support may be provided to the coronary wall with a generally cylindrical and expandable braid (stent) inserted into the stenotic vessel by means of a balloon catheter and deployed at the site of the stenosis to open the stenotic site.
  • stent generally cylindrical and expandable braid
  • vascular smooth muscle cells vascular smooth muscle cells
  • a more recent option for the treatment of restenosis is the local administration of drugs by means of a stent, which releases the drug.
  • the combination of drug and stent allows for drug treatment and mechanical stabilization in one application.
  • stents can be coated with active substance-containing coating materials.
  • the release of active ingredient takes place by diffusion from the lacquer or by degradation of the lacquer when using biodegradable lacquer systems.
  • drug-containing stents by melt embedding of the active ingredient in a polymeric carrier z. B. using injection molding. The release of the drug takes place in these stents usually by diffusion.
  • connection of stents with antiproliferative agents allows a high local concentration of active ingredient, without causing the undesirable systemic side effects.
  • angiotensin II type 1 (ATi) receptor is involved in the restenosis after vascular angioplasty.
  • ATi angiotensin II type 1
  • renin-angiotensin (RAS) system is also involved in other processes responsible for restenosis following balloon angioplasty via the angiotensin receptor.
  • angiotensin conversion enzyme ACE
  • AT r receptors are found in macrophages. Less strong ATi-positive smooth muscle cells were observed. In-stent lesions consisted mainly of ATi-expressing VSMCs. (Wagenaar LJ, Van Boven AJ, Van der Wal AC, Cardiovascular Research 2003; 59; 980-987)
  • drugs for patients undergoing transluminal those with the mechanism of action may be particularly suitable as angiotensin II type 1 receptor blockers or ATp receptor antagonists, however, in cases where lowering blood pressure is undesirable, the systemic administration of such ARBs should be preventive or treatment of restenosis after PTCA or PTA with or without laying of stents less suitable.
  • a treatment of restenosis with such ARBs by local application by means of stents which release these active substances slowly is extremely possible, and in particular in the case of the stenotic patient, the risk of hypotension exists.
  • the new combination of ARBs with a stent enables a more effective treatment and / or prophylaxis of restenosis and / or vulnerable plaques.
  • the local concentration can be increased and thus the effectiveness can be increased.
  • the present invention therefore relates to active ingredient-containing stents containing at least one angiotensin II type 1 receptor antagonist.
  • the invention relates to methods for producing stents, characterized in that the stents are coated with at least one material containing an angiotensin II type 1 receptor antagonist.
  • the invention relates to methods for producing stents, characterized in that the stents are filled with at least one material containing an angiotensin II type 1 receptor antagonist.
  • the invention also relates to the use of angiotensin II type 1 receptor antagonists for the preparation of stents containing them.
  • angiotensin II type 1 receptor antagonists substances which are referred to as sartans.
  • Angiotensin II type 1 receptor antagonists are said to be synonymous with angiotensin II type 1 receptor blockers.
  • Sartane are structurally more or less related to each other and are z.
  • B derived from modified at the amino group at least by carboxy or 5-tetrazolyl 2'-substituted 4-aminomethyldiphenyl or para-substituted on the benzene ring 1-benzylimidazole.
  • Particularly preferred are the compounds with the common names Candes artan, eprosartan, irbesartan, losartan, telmisartan and valsartan. Most preferred is telmisartan.
  • stents are used, for example, to manufacture the stents according to the invention, the stent basic body being made of metals or non-degradable plastics such as, for example, polyethylene, polypropylene, polycarbonate, polyurethane and / or polytetrafluoroethylene (PTFE).
  • PTFE polytetrafluoroethylene
  • stent basic stents with different constructions of the metal mesh which allow different surfaces and folding principles and as, for example, in WO 01/037761 on page 2 Z. 19 to S. 5 line 22 and Figures 1 to 6 and in WO 01/037892 on the Sl Z. 12 to page 2 line 13, p. 6 Z. 1 to 12 and in the detailed description of page 7 line 22 et seq. (to p. 13 end) described.
  • stents are coated and / or filled with the active ingredients.
  • the active ingredients may be incorporated directly into the material used to make the stents.
  • carrier materials are mixed with the active ingredients.
  • the carrier materials used are preferably polymeric carriers, in particular biocompatible, non-biodegradable polymers or polymer blends, such as, by way of example and by way of preference, polyacrylates and copolymers thereof, by way of example and preferably poly (hydroxyethyl) methyl methacrylates; polyvinylpyrrolidones; Cellulose esters and ethers; fluorinated polymers such as by way of example and preferably PTFE; Polyvinyl acetates and their copolymers; crosslinked and uncrosslinked polyurethanes, polyethers or polyesters; polycarbonates; Polydimethylsiloxanes.
  • biocompatible, biodegradable polymers or polymer blends such as by way of example and preferably polymers or copolymers of lactide and glycolide, or from prolacton and glycolide; other polyesters; polyorthoesters; polyanhydrides; polyaminoacids; Polysaccharides; polyiminocarbonates; Polyphosphazenes and poly (ether-ester) copolymers used as polymeric carriers.
  • AIs polymeric carrier are also suitable mixtures of biodegradable and / or non-biodegradable polymers. Through these mixtures, the release rate of the drug is optimally adjusted.
  • the release of the drug may be either by diffusion from the layer or by degradation of the same if a biodegradable system is used.
  • the mixtures of active ingredient (s) and carrier are dissolved, preferably in suitable solvents. These solutions are then replaced by various techniques such. As spraying, dipping or brushing applied to the stent. After subsequent or simultaneous removal of the solvent, the stent, which has been mixed with active substance-containing lacquer, is thus produced.
  • mixtures of active ingredients) and carriers can be melted and applied by the same application methods.
  • the stents are pretreated to effect an enlargement of the outer and / or inner stent surface.
  • the loading potential is increased and larger paint (drug / polymer) amounts can be applied.
  • different etching techniques for example, different etching techniques but also treatments with ionized radiation are used.
  • micropores or cavities can be created in the stents by various techniques.
  • the active substance contents of the coated or filled stents are as a rule from 0.001% by weight to 50% by weight, preferably from 0.01% by weight to 30% by weight, particularly preferably 0.1% by weight. to 15% by weight in the coating or filling.
  • the active ingredients can also be incorporated directly into the stent base, for example as a melt embedding.
  • active-ingredient-containing polymeric carrier compositions are processed by customary processes, for example by injection molding, to give the final active ingredient-containing form.
  • the release of the active ingredient takes place in the rule, by diffusion.
  • the active substance contents of stents with embedded active ingredients are as a rule from 0.001% by weight to 70% by weight, preferably from 0.01% by weight to 50% by weight, particularly preferably 0.1% by weight to 30 wt .-% based on the total mass of the material.
  • the active substance-containing stents are optionally additionally coated with a membrane. This membrane serves, by way of example and preferably, for controlling the release of medicaments and / or for protecting the active substance-containing stents from external influences.
  • the invention further relates to the use of angiotensin II type 1 receptor antagonist-containing stents for the treatment of restenosis and arteriosclerotic deposits such as vulnerable plaques.
  • the invention further relates to the use of angiotensin II type 1 receptor antagonist-containing stents for the prevention of restenosis and arteriosclerotic deposits such as vulnerable plaques after transluminal (coronary) angioplasty (PTCA or PTA) and placement of a stent.
  • angiotensin II type 1 receptor antagonist-containing stents for the prevention of restenosis and arteriosclerotic deposits such as vulnerable plaques after transluminal (coronary) angioplasty (PTCA or PTA) and placement of a stent.
  • systemic and / or local administration of further active substances suitable for the treatment and / or prophylaxis of restenosis and / or vulnerable plaques such as by way of example and preferably abciximab, eptifibatide, tirofiban, acetylsalicylic acid, ticlopidine or clopidogrel.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Surgery (AREA)
  • Vascular Medicine (AREA)
  • Molecular Biology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Materials For Medical Uses (AREA)

Abstract

L'invention concerne des tuteurs intravasculaires contenant des antagonistes du récepteur de l'angiotensine, ainsi que des procédés permettant de produire lesdits tuteurs intravasculaires.
PCT/EP2005/012675 2004-12-08 2005-11-28 Tuteurs intravasculaires delivrant un principe actif WO2006061115A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
DE102004058966 2004-12-08
DE102004058966.6 2004-12-08
DE102005010998A DE102005010998A1 (de) 2004-12-08 2005-03-10 Wirkstoff abgebende Stents
DE102005010998.5 2005-03-10

Publications (1)

Publication Number Publication Date
WO2006061115A1 true WO2006061115A1 (fr) 2006-06-15

Family

ID=35976605

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2005/012675 WO2006061115A1 (fr) 2004-12-08 2005-11-28 Tuteurs intravasculaires delivrant un principe actif

Country Status (2)

Country Link
DE (1) DE102005010998A1 (fr)
WO (1) WO2006061115A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20180280584A1 (en) * 2015-12-22 2018-10-04 Lifetech Scientific (Shenzhen) Co., Ltd Absorbable Iron-based Alloy Implanted Medical Device

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102007034364A1 (de) 2007-07-24 2009-01-29 Biotronik Vi Patent Ag Degradierbarer Metallstent mit wirkstoffhaltiger Beschichtung
BR112012014316A2 (pt) 2009-12-16 2016-07-05 Bayer Materialscience Ag poliuretano-uréia para revestimentos de stent

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002007601A2 (fr) * 2000-07-20 2002-01-31 Jomed Imaging Limited Catheters d'imagerie ultrasonores
WO2002085253A1 (fr) * 2001-04-20 2002-10-31 The Board Of Trustees Of The Leland Stanford Junior University Plate-forme d'administration de medicaments et procedes d'inhibition de la formation de la neointima
WO2003037220A1 (fr) * 2001-10-30 2003-05-08 Boehringer Ingelheim Pharma Gmbh & Co. Kg Dispositif ameliore d'endoprothese
WO2004045474A1 (fr) * 2002-11-15 2004-06-03 Gmp Cardiac Care, Inc. Stent à rails

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002007601A2 (fr) * 2000-07-20 2002-01-31 Jomed Imaging Limited Catheters d'imagerie ultrasonores
WO2002085253A1 (fr) * 2001-04-20 2002-10-31 The Board Of Trustees Of The Leland Stanford Junior University Plate-forme d'administration de medicaments et procedes d'inhibition de la formation de la neointima
WO2003037220A1 (fr) * 2001-10-30 2003-05-08 Boehringer Ingelheim Pharma Gmbh & Co. Kg Dispositif ameliore d'endoprothese
WO2004045474A1 (fr) * 2002-11-15 2004-06-03 Gmp Cardiac Care, Inc. Stent à rails

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20180280584A1 (en) * 2015-12-22 2018-10-04 Lifetech Scientific (Shenzhen) Co., Ltd Absorbable Iron-based Alloy Implanted Medical Device
US11623028B2 (en) * 2015-12-22 2023-04-11 Biotyx Medical (Shenzhen) Co., Ltd. Absorbable iron-based alloy implanted medical device

Also Published As

Publication number Publication date
DE102005010998A1 (de) 2006-06-29

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