DK2854887T3 - Belægning af ballonkatetere - Google Patents

Belægning af ballonkatetere Download PDF

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Publication number
DK2854887T3
DK2854887T3 DK13729622.4T DK13729622T DK2854887T3 DK 2854887 T3 DK2854887 T3 DK 2854887T3 DK 13729622 T DK13729622 T DK 13729622T DK 2854887 T3 DK2854887 T3 DK 2854887T3
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DK
Denmark
Prior art keywords
balloon
solution
process according
active agent
alcohol
Prior art date
Application number
DK13729622.4T
Other languages
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.)
Filing date
Publication date
Application filed by Aachen Scient International Pte Ltd filed Critical Aachen Scient International Pte Ltd
Application granted granted Critical
Publication of DK2854887T3 publication Critical patent/DK2854887T3/da

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1027Making of balloon catheters
    • A61M25/1029Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
    • 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
    • A61L29/00Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/08Materials for coatings
    • A61L29/085Macromolecular 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
    • A61L29/00Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/14Materials characterised by their function or physical properties, e.g. lubricating compositions
    • A61L29/16Biologically 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
    • 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
    • A61L2300/602Type of release, e.g. controlled, sustained, slow
    • 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
    • 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
    • A61L2420/06Coatings containing a mixture of two or more compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1027Making of balloon catheters
    • A61M25/1029Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
    • A61M2025/1031Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/105Balloon catheters with special features or adapted for special applications having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Molecular Biology (AREA)
  • Manufacturing & Machinery (AREA)
  • Child & Adolescent Psychology (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Materials For Medical Uses (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Polymers & Plastics (AREA)
  • Organic Chemistry (AREA)

Claims (14)

1. Fremgangsmåde til belægning af ballonen på et ballonkateter, hvor - overfladen på ballonen befugtes i det mindste delvis med en første opløsning af et aktivt middel og - den del af overfladen af ballonen, som er befugtet med den første opløsning af et aktivt middel, befugtes med en væske indeholdende vand og/eller i det mindste én alkohol, kendetegnet ved, at den del af ballonen, som er befugtet med den første opløsning og væsken, som indeholder vand og/eller i det mindste én alkohol, befugtes med en yderligere opløsning, som indeholder en dextran.
2. Fremgangsmåde ifølge krav 1, kendetegnet ved, at væsken, som indeholder vand og/eller i det mindste en af alkohol, indeholder en alkohol og/eller en keton.
3. Fremgangsmåde ifølge krav 2, kendetegnet ved, at koncentrationen af alkoholen og/eller ketonen i væsken ligger imellem 10 og 70% (v/v), fortrinsvis imellem 30 og 65% (v/v), yderligere foretrukkent imellem 50 og 60% (v/v).
4. Fremgangsmåde ifølge krav 2 eller 3, kendetegnet ved, at væsken indeholder ethanol, methanol, acetone og/eller isopropanol.
5. Fremgangsmåde ifølge ethvert af kravene 1 til 4, kendetegnet ved, at den yderligere opløsning indeholder én eller adskillige alkoholer.
6. Fremgangsmåde ifølge krav 5, kendetegnet ved, at koncentrationen af alkoholen i vand i den yderligere opløsning ligger imellem 10 og 70% (v/v), fortrinsvis imellem 30 og 65% (v/v), yderligere foretrukkent imellem 50 og 60% (v/v).
7. Fremgangsmåde ifølge krav 5 eller 6, kendetegnet ved, at den yderligere opløsning indeholder ethanol, methanol og/eller isopropanol.
8. Fremgangsmåde ifølge ethvert af kravene 1 til 7, kendetegnet ved, at den gennemsnitlige molmasse for dextranen ligger imellem 10.000 og 100.000.000 Da.
9. Fremgangsmåde ifølge krav 8, kendetegnet ved, at den gennemsnitlige molmasse for dextranen ligger imellem 20.000 og 80.000 Da.
10. Fremgangsmåde ifølge ethvert af kravene 1 til 9, kendetegnet ved, at det aktive middel, som anvendes, er valgt fra følgende gruppe: tretinoin, orphanreceptoragonister, elafinderivat, corticosteroid, steroidhormon, paclitaxel, rapamycin, tacrolimus, hydro-phob protein og/eller celleproliferationsmodificerende substanser.
11. Fremgangsmåde ifølge ethvert af kravene 1 til 10, kendetegnet ved, at overfladen på ballonen, efter befugtning med den første opløsning af aktivstoffet og før befugtning med væsken, som indeholder vand og/eller i det mindste en alkohol, befugtes med en yderligere opløsning af det samme eller et andet aktivt stof.
12. Ballon for et ballonkateter, hvis overflade i det mindste delvis er forsynet med en belægning med et aktivt stof, opnåelig ved en fremgangsmåde ifølge ethvert af kravene 1 til 11.
13. Ballonkateter omfattende en ballon ifølge krav 12.
14. Ballonkateter ifølge krav 13, kendetegnet ved, at det aktive stof er tilvejebragt på overfladen af ballonen og dextranen dækker det aktive stof.
DK13729622.4T 2012-06-01 2013-06-03 Belægning af ballonkatetere DK2854887T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102012010800A DE102012010800A1 (de) 2012-06-01 2012-06-01 Beschichtung von Ballonkathetern
PCT/EP2013/061352 WO2013178820A1 (de) 2012-06-01 2013-06-03 Beschichtung von ballonkathetern

Publications (1)

Publication Number Publication Date
DK2854887T3 true DK2854887T3 (da) 2018-01-22

Family

ID=48651989

Family Applications (1)

Application Number Title Priority Date Filing Date
DK13729622.4T DK2854887T3 (da) 2012-06-01 2013-06-03 Belægning af ballonkatetere

Country Status (8)

Country Link
US (1) US9907935B2 (da)
EP (3) EP3988141A1 (da)
JP (1) JP2015522322A (da)
DE (1) DE102012010800A1 (da)
DK (1) DK2854887T3 (da)
ES (1) ES2655963T3 (da)
PL (1) PL2854887T3 (da)
WO (1) WO2013178820A1 (da)

Families Citing this family (3)

* 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
DE102018100748A1 (de) * 2018-01-15 2019-07-18 Alexander Ruebben Polysaccharidbeschichtung
DE102018123050B4 (de) 2018-09-19 2020-08-13 Alexander Ruebben Wirkstoffbeschichtung für Ballons von Ballonkathetern

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5102402A (en) 1991-01-04 1992-04-07 Medtronic, Inc. Releasable coatings on balloon catheters
US6129705A (en) 1997-10-01 2000-10-10 Medtronic Ave, Inc. Drug delivery and gene therapy delivery system
EP1501565B1 (de) * 2002-05-09 2006-11-02 Hemoteq GmbH Verbindungen und verfahren zur hemokompatiblen beschichtung von oberflächen
US20070065483A1 (en) * 2005-09-21 2007-03-22 Chudzik Stephen J In vivo formed matrices including natural biodegradable polysaccharides and uses thereof
DE102007003184A1 (de) 2007-01-22 2008-07-24 Orlowski, Michael, Dr. Verfahren zur Beladung von strukturierten Oberflächen
US8070798B2 (en) * 2007-07-20 2011-12-06 Josiah Wilcox Drug eluting medical device and method
DE102008034826A1 (de) * 2008-07-22 2010-01-28 Alexander Rübben Verfahren zur Erzeugung einer bioaktiven Oberfläche auf dem Ballon eines Ballonkatheters
DK2646066T3 (da) * 2010-12-04 2018-06-25 Aachen Scient International Pte Ltd Belægning og belægningsfremgangsmåde for ballonen på et ballonkateter samt ballonkateter med belagt ballon

Also Published As

Publication number Publication date
PL2854887T3 (pl) 2018-10-31
ES2655963T3 (es) 2018-02-22
WO2013178820A1 (de) 2013-12-05
EP3287152B1 (de) 2021-12-22
US9907935B2 (en) 2018-03-06
EP2854887A1 (de) 2015-04-08
DE102012010800A1 (de) 2013-12-05
EP3988141A1 (de) 2022-04-27
US20150258311A1 (en) 2015-09-17
EP3287152A1 (de) 2018-02-28
EP2854887B1 (de) 2017-10-18
JP2015522322A (ja) 2015-08-06

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