CA2743022A1 - Methods for coating catheter balloons with a defined quantity of active agent - Google Patents

Methods for coating catheter balloons with a defined quantity of active agent Download PDF

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Publication number
CA2743022A1
CA2743022A1 CA2743022A CA2743022A CA2743022A1 CA 2743022 A1 CA2743022 A1 CA 2743022A1 CA 2743022 A CA2743022 A CA 2743022A CA 2743022 A CA2743022 A CA 2743022A CA 2743022 A1 CA2743022 A1 CA 2743022A1
Authority
CA
Canada
Prior art keywords
citrate
active agent
acetyl
ester
coating
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
CA2743022A
Other languages
French (fr)
Other versions
CA2743022C (en
Inventor
Erika Hoffmann
Roland Horres
Volker Faust
Helmut Schreiber
Armin Von Holst
Michael Hoffmann
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.)
Hemoteq AG
Original Assignee
Hemoteq AG
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
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=39523684&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2743022(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Hemoteq AG filed Critical Hemoteq AG
Publication of CA2743022A1 publication Critical patent/CA2743022A1/en
Application granted granted Critical
Publication of CA2743022C publication Critical patent/CA2743022C/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
    • A61M—DEVICES 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1027—Making of balloon catheters
    • A61M25/1029—Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
    • 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
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/08—Materials for coatings
    • 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
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
    • A61L29/16—Biologically active materials, e.g. therapeutic substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M25/00—Catheters; Hollow probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • 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
    • 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
    • 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
    • A61L2300/80—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special chemical form
    • A61L2300/802—Additives, excipients, e.g. cyclodextrins, fatty acids, surfactants
    • 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
    • A61L2420/02—Methods for coating medical devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M2025/0057—Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1027—Making of balloon catheters
    • A61M25/1029—Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
    • A61M2025/1031—Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1088—Balloon catheters with special features or adapted for special applications having special surface characteristics depending on material properties or added substances, e.g. for reducing friction

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Anesthesiology (AREA)
  • Pulmonology (AREA)
  • Biophysics (AREA)
  • Hematology (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Child & Adolescent Psychology (AREA)
  • Molecular Biology (AREA)
  • Manufacturing & Machinery (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oncology (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Urology & Nephrology (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Communicable Diseases (AREA)
  • Materials For Medical Uses (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

The present invention is directed to a method for coating catheter balloons with a defined amount of a pharmacologically active agent, wherein the coating method uses a coating device having a volume measuring device for releasing a measurable amount of a coating solution by means of a dispensing device specifically onto the surface of the catheter balloon.

Claims (8)

1 Use of a citrate ester and an anti-inflammatory, cystostatic, cytotoxic, antiproliferative, anti-microtubuli, anti-angiogenic anti-restenotic, antifungicide, antineoplastic, antimigrative, athrombogenic or antithrombogenic active agent for the coating of catheter balloons.
2. The use according to claim 1, wherein the citrate ester is acetyl tributyl citrate or acetyl triethyl citrate or a compound having the formula:

wherein R, R' and R" are independently from each other hydrogen or an alkyl, arylalkyl or cycloalkyl residue which are linear or branched, saturated or unsaturated, and unsubstituted or substituted with at least one functional group.
3. The use according to claim 1, wherein the citrate ester is triethyl citrate, acetyl triethyl citrate, tributyl citrate, or acetyl tributyl citrate.
4. The use according to claim 1, wherein the at least one anti-inflammatory, cystostatic, cytotoxic, antiproliferative, anti-microtubuli, anti-angiogenic anti-restenotic, antifungicide, antineoplastic, antimigrative, athrombogenic or antithrombogenic active agent is paclitaxel.
5. A catheter balloon coated with at least one anti-inflammatory, cystostatic, cytotoxic, antiproliferative, anti-microtubuli, anti-angiogenic anti-restenotic, antifungicide, antineoplastic, antimigrative, athrombogenic or antithrombogenic active agent and a citrate ester.
6. The catheter balloon according to claim 5, wherein the citrate ester is acetyl tributyl citrate or acetyl triethyl citrate or a compound having the formula:
wherein R, R' and R" are independently from each other hydrogen or an alkyl, arylalkyl or cycloalkyl residue which are linear or branched, saturated or unsaturated, and unsubstituted or substituted with at least one functional group.
7. The catheter balloon according to claim 5, wherein the citrate ester is triethyl citrate, acetyl triethyl citrate, tributyl citrate, or acetyl tributyl citrate.
8. The catheter balloon according to claim 5, wherein the at least one anti-inflammatory, cystostatic, cytotoxic, antiproliferative, anti-microtubuli, anti-angiogenic anti-restenotic, antifungicide, antineoplastic, antimigrative, athrombogenic or antithrombogenic active agent is paclitaxel.
CA2743022A 2007-01-21 2008-01-21 Methods for coating catheter balloons with a defined quantity of active agent Active CA2743022C (en)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
DE102007003914.1 2007-01-21
DE102007003914 2007-01-21
DE102007006557 2007-02-09
DE102007006557.6 2007-02-09
DE102007013586 2007-03-21
DE102007013586.8 2007-03-21
CA2673991A CA2673991C (en) 2007-01-21 2008-01-21 Methods for coating catheter balloons with a defined quantity of active agent

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
CA2673991A Division CA2673991C (en) 2007-01-21 2008-01-21 Methods for coating catheter balloons with a defined quantity of active agent

Publications (2)

Publication Number Publication Date
CA2743022A1 true CA2743022A1 (en) 2008-07-24
CA2743022C CA2743022C (en) 2012-10-09

Family

ID=39523684

Family Applications (2)

Application Number Title Priority Date Filing Date
CA2743022A Active CA2743022C (en) 2007-01-21 2008-01-21 Methods for coating catheter balloons with a defined quantity of active agent
CA2673991A Active CA2673991C (en) 2007-01-21 2008-01-21 Methods for coating catheter balloons with a defined quantity of active agent

Family Applications After (1)

Application Number Title Priority Date Filing Date
CA2673991A Active CA2673991C (en) 2007-01-21 2008-01-21 Methods for coating catheter balloons with a defined quantity of active agent

Country Status (17)

Country Link
US (2) US8597720B2 (en)
EP (3) EP2269664B1 (en)
JP (2) JP4906926B2 (en)
KR (3) KR101198980B1 (en)
CN (2) CN101687066B (en)
AU (2) AU2008207191B2 (en)
BR (2) BRPI0806727B8 (en)
CA (2) CA2743022C (en)
DE (1) DE112008000881A5 (en)
ES (2) ES2393639T3 (en)
IL (2) IL199568A (en)
MX (2) MX2009007663A (en)
NZ (2) NZ578341A (en)
PL (2) PL2136853T3 (en)
RU (2) RU2447901C2 (en)
WO (1) WO2008086794A2 (en)
ZA (1) ZA201007601B (en)

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