DK3043838T3 - Belægning af en vaskulær endoprotese - Google Patents

Belægning af en vaskulær endoprotese Download PDF

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Publication number
DK3043838T3
DK3043838T3 DK14784004.5T DK14784004T DK3043838T3 DK 3043838 T3 DK3043838 T3 DK 3043838T3 DK 14784004 T DK14784004 T DK 14784004T DK 3043838 T3 DK3043838 T3 DK 3043838T3
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DK
Denmark
Prior art keywords
vascular endoprosthesis
active substance
vascular
polysaccharide
endoprosthesis
Prior art date
Application number
DK14784004.5T
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English (en)
Inventor
Alexander Rübben
Original Assignee
Aachen Scient International Pte Ltd
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.)
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Publication date
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Publication of DK3043838T3 publication Critical patent/DK3043838T3/da

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/54Biologically active materials, e.g. therapeutic substances
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28Materials for coating prostheses
    • A61L27/34Macromolecular materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L31/00Materials 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
    • A61L31/08Materials for coatings
    • A61L31/10Macromolecular materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/10Drugs 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
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B05SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05DPROCESSES FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05D1/00Processes for applying liquids or other fluent materials
    • B05D1/002Processes for applying liquids or other fluent materials the substrate being rotated
    • CCHEMISTRY; METALLURGY
    • C09DYES; PAINTS; POLISHES; NATURAL RESINS; ADHESIVES; COMPOSITIONS NOT OTHERWISE PROVIDED FOR; APPLICATIONS OF MATERIALS NOT OTHERWISE PROVIDED FOR
    • C09DCOATING COMPOSITIONS, e.g. PAINTS, VARNISHES OR LACQUERS; FILLING PASTES; CHEMICAL PAINT OR INK REMOVERS; INKS; CORRECTING FLUIDS; WOODSTAINS; PASTES OR SOLIDS FOR COLOURING OR PRINTING; USE OF MATERIALS THEREFOR
    • C09D105/00Coating compositions based on polysaccharides or on their derivatives, not provided for in groups C09D101/00 or C09D103/00
    • C09D105/02Dextran; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/60Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/606Coatings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/60Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/606Coatings
    • A61L2300/608Coatings having two or more layers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2420/00Materials or methods for coatings medical devices
    • A61L2420/02Methods for coating medical devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2420/00Materials or methods for coatings medical devices
    • A61L2420/08Coatings comprising two or more layers

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Vascular Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Organic Chemistry (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Dermatology (AREA)
  • Surgery (AREA)
  • Materials Engineering (AREA)
  • Wood Science & Technology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • Urology & Nephrology (AREA)
  • Cardiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Materials For Medical Uses (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Prostheses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Claims (15)

1. Fremgangsmåde til belægning afen vaskulær endoprotese, hvilken fremgangsmåde omfatter følgende trin: a) i det mindste en delvis befugtning af ydersiden af den vaskulære endoprotese med en første opløsning af en aktiv substans; b) bevægelse af den vaskulære endoprotese med en rotationsbevægelse omkring den langsgående akse for den vaskulære endoprotese; c) påføring af en radialt virkende mekanisk kraft på ydersiden af den vaskulære endoprotese.
2. Fremgangsmåde ifølge krav 1, kendetegnet ved, at den radialt virkende mekaniske kraft påføres på ydersiden af den vaskulære endoprotese ved at rulle den vaskulære endoprotese over en overflade under udøvelse af et tryk.
3. Fremgangsmåde ifølge krav 2, kendetegnet ved, at overfladen er en elastomer overflade, især en gummioverflade.
4. Fremgangsmåde ifølge ethvert af kravene 1 til 3, kendetegnet ved, at den vaskulære endoprotese bevæges i en rotationsbevægelse omkring den langsgående akse med en rotationshastighed på i det mindste 1000 omdr/min., fortrinsvis i det mindste 2000 omdr/min., især fortrinsvis i det mindste 5000 omdr/min.
5. Fremgangsmåde ifølge ethvert af kravene 1 til 4, kendetegnet ved, at den første opløsning omfatter chloroform eller dichlormethan som opløsningsmiddel.
6. Fremgangsmåde ifølge ethvert af kravene 1 til 5, kendetegnet ved, at den anvendte aktive substans er valgt fra gruppen bestående af: tretinoin, orphanreceptoragonister, elafinderivater, corticosteroider, steroidhormoner, paclitaxel, rapamycin, sirolimus, tacrolimus, hydrofobe proteiner og/eller celleproliferationsændrende substanser.
7. Fremgangsmåde ifølge ethvert af kravene 1 til 6, omfattende som et yderligere trin: d) befugtning af de områder af ydersiden af den vaskulære endoprotese, som er befugtet med den første opløsning af den aktive substans, med en væske omfattende vand og/eller i det mindste én alkohol; hvor trin d) udøves efter trinnene (a) til (c).
8. Fremgangsmåde ifølge krav 7, kendetegnet ved, at væsken, som omfatter vand og/eller i det mindste én alkohol, omfatter en alkohol og/eller en keton.
9. Fremgangsmåde ifølge krav 8, kendetegnet ved, at koncentrationen af alkoholen og/eller ketonen i væsken udgør 10 op til 70% (v/v), fortrinsvis 20 til 40% (v/v).
10. Fremgangsmåde ifølge ethvert af kravene 7 til 9, kendetegnet ved, at væsken omfatter ethanol, methanol, acetone og/eller isopropanol.
11. Fremgangsmåde ifølge ethvert af kravene 1 til 10, omfattende som et yderligere trin: e) befugtning af de områder af ydersiden af den vaskulære endoprotese, som er befugtede med den første opløsning og, hvis nogen, med væsken omfattende vand og/eller i det mindste én alkohol, med en yderligere opløsning, som omfatter et polysaccharid; hvor trin (e) udøves efter trinnene (a) til (c) eller (a) til (d).
12. Fremgangsmåde ifølge krav 11, kendetegnet ved, at middelmolekylmassen for polysaccharidet udgør 10.000 op til 100.000.000 Da, fortrinsvis 20.000 op til 80.000 Da.
13. Fremgangsmåde ifølge krav 11 eller 12, kendetegnet ved, at polysaccharidet er en dextran.
14. Vaskulær endoprotese, hvis yderside i det mindste delvis har en belægning med paclitaxel, som kan tilvejebringes ved hjælp af en fremgangsmåde ifølge ethvert af kravene 6 til 13.
15. Vaskulær endoprotese, hvis yderside i det mindste delvis har en belægning med en aktiv substans, som kan tilvejebringes ved hjælp af en fremgangsmåde ifølge ethvert af kravene 11 til 13, kendetegnet ved, at den aktive substrans er dækket af poly-saccharidet.
DK14784004.5T 2013-09-10 2014-09-08 Belægning af en vaskulær endoprotese DK3043838T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE201310014821 DE102013014821A1 (de) 2013-09-10 2013-09-10 Gefäßendoprothesenbeschichtung
PCT/EP2014/069030 WO2015036343A1 (de) 2013-09-10 2014-09-08 GEFÄßENDOPROTHESENBESCHICHTUNG

Publications (1)

Publication Number Publication Date
DK3043838T3 true DK3043838T3 (da) 2018-09-17

Family

ID=51703130

Family Applications (1)

Application Number Title Priority Date Filing Date
DK14784004.5T DK3043838T3 (da) 2013-09-10 2014-09-08 Belægning af en vaskulær endoprotese

Country Status (8)

Country Link
US (2) US9808559B2 (da)
EP (1) EP3043838B1 (da)
JP (2) JP6551802B2 (da)
DE (1) DE102013014821A1 (da)
DK (1) DK3043838T3 (da)
ES (1) ES2686138T3 (da)
PL (1) PL3043838T3 (da)
WO (1) WO2015036343A1 (da)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102014014771A1 (de) * 2014-10-10 2016-04-14 Alexander Rübben Gefäßendoprothesenbeschichtung

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Also Published As

Publication number Publication date
WO2015036343A1 (de) 2015-03-19
JP6551802B2 (ja) 2019-07-31
ES2686138T3 (es) 2018-10-16
EP3043838B1 (de) 2018-06-06
PL3043838T3 (pl) 2019-01-31
DE102013014821A1 (de) 2015-03-12
US10994053B2 (en) 2021-05-04
JP6820974B2 (ja) 2021-01-27
JP2019150678A (ja) 2019-09-12
US20160220733A1 (en) 2016-08-04
EP3043838A1 (de) 2016-07-20
JP2017500949A (ja) 2017-01-12
US20180043060A1 (en) 2018-02-15
US9808559B2 (en) 2017-11-07

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