PL2982303T3 - Urządzenie medyczne i sposób wytwarzania urządzenia medycznego - Google Patents

Urządzenie medyczne i sposób wytwarzania urządzenia medycznego

Info

Publication number
PL2982303T3
PL2982303T3 PL14180045T PL14180045T PL2982303T3 PL 2982303 T3 PL2982303 T3 PL 2982303T3 PL 14180045 T PL14180045 T PL 14180045T PL 14180045 T PL14180045 T PL 14180045T PL 2982303 T3 PL2982303 T3 PL 2982303T3
Authority
PL
Poland
Prior art keywords
medical device
producing
medical
Prior art date
Application number
PL14180045T
Other languages
English (en)
Inventor
Frank Deck
Original Assignee
F. Hoffmann-La Roche 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
Application filed by F. Hoffmann-La Roche Ag filed Critical F. Hoffmann-La Roche Ag
Publication of PL2982303T3 publication Critical patent/PL2982303T3/pl

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/1468—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means
    • A61B5/1486—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means using enzyme electrodes, e.g. with immobilised oxidase
    • A61B5/14865—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means using enzyme electrodes, e.g. with immobilised oxidase invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14546—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue for measuring analytes not otherwise provided for, e.g. ions, cytochromes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6848—Needles
    • A61B5/6849—Needles in combination with a needle set
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/30—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
    • 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
    • A61L2/00—Disinfection or sterilisation of materials or objects, in general; Accessories therefor
    • A61L2/02—Disinfection or sterilisation of materials or objects, in general; Accessories therefor using physical processes
    • A61L2/08—Radiation
    • A61L2/081—Gamma radiation
    • 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
    • A61L2/00—Disinfection or sterilisation of materials or objects, in general; Accessories therefor
    • A61L2/02—Disinfection or sterilisation of materials or objects, in general; Accessories therefor using physical processes
    • A61L2/08—Radiation
    • A61L2/087—Particle radiation, e.g. electron-beam, alpha or beta radiation
    • 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
    • A61L2/00—Disinfection or sterilisation of materials or objects, in general; Accessories therefor
    • A61L2/16—Disinfection or sterilisation of materials or objects, in general; Accessories therefor using chemical substances
    • A61L2/20—Gaseous substances, e.g. vapours
    • A61L2/206—Ethylene oxide
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/18—Shielding or protection of sensors from environmental influences, e.g. protection from mechanical damage
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/24—Hygienic packaging for medical sensors; Maintaining apparatus for sensor hygiene
    • A61B2562/242—Packaging, i.e. for packaging the sensor or apparatus before use
    • 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
    • A61L2103/00—Materials or objects being the target of disinfection or sterilisation
    • A61L2103/05—Living organisms or biological materials

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Pathology (AREA)
  • Biophysics (AREA)
  • Optics & Photonics (AREA)
  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Emergency Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Electrotherapy Devices (AREA)
PL14180045T 2014-08-06 2014-08-06 Urządzenie medyczne i sposób wytwarzania urządzenia medycznego PL2982303T3 (pl)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP14180045.8A EP2982303B1 (en) 2014-08-06 2014-08-06 Medical device and method for producing a medical device

Publications (1)

Publication Number Publication Date
PL2982303T3 true PL2982303T3 (pl) 2017-08-31

Family

ID=51266186

Family Applications (1)

Application Number Title Priority Date Filing Date
PL14180045T PL2982303T3 (pl) 2014-08-06 2014-08-06 Urządzenie medyczne i sposób wytwarzania urządzenia medycznego

Country Status (9)

Country Link
US (1) US10939858B2 (pl)
EP (1) EP2982303B1 (pl)
CN (1) CN106535765B (pl)
CA (1) CA2956116C (pl)
DK (1) DK2982303T3 (pl)
PL (1) PL2982303T3 (pl)
RU (1) RU2697996C2 (pl)
SI (1) SI2982303T1 (pl)
WO (1) WO2016020370A1 (pl)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RS65949B1 (sr) 2016-02-05 2024-10-31 Hoffmann La Roche Medicinski uređaj za detekciju najmanje jednog analita u telesnoj tečnosti
RS66282B1 (sr) 2016-02-05 2025-01-31 Hoffmann La Roche Medicinski uređaj za detekciju najmanje jednog analita u telesnoj tečnosti
US11806134B2 (en) * 2017-05-09 2023-11-07 Ascensia Diabetes Care Holdings Ag Sensor assembly apparatus and methods for continuous glucose monitors
RS66567B1 (sr) 2017-12-21 2025-03-31 Hoffmann La Roche Medicinski sistem i postupak za njegovu proizvodnju
HUE066791T2 (hu) * 2019-07-04 2024-09-28 Hoffmann La Roche Beültetõtû szubkután beültethetõ elem testszövetbe történõ beültetésére
US11707297B2 (en) 2019-08-20 2023-07-25 Ascensia Diabetes Care Holdings Ag Continuous analyte monitor inserter apparatus and methods
US11602373B2 (en) 2019-08-20 2023-03-14 Ascensia Diabetes Care Holdings Ag Biosensor inserter apparatus and methods
US20210369152A1 (en) * 2020-06-02 2021-12-02 Ascensia Diabetes Care Holdings Ag Methods and apparatus configured to transmit data in continuous analyte monitors
US20230301556A1 (en) 2020-08-26 2023-09-28 Tingo Medical Ltd. Continuous glucose sensor and mounting assembly
EP4503883A3 (en) 2020-09-07 2025-07-30 Ascensia Diabetes Care Holdings AG Methods and apparatus enabling coupling of an electronics unit to a base unit of a continuous analyte monitoring device
JP2024504677A (ja) 2021-01-21 2024-02-01 アセンシア・ダイアベティス・ケア・ホールディングス・アーゲー ウェアラブルな連続的な分析物測定デバイス、バイオセンサ挿入器、及び使用方法
JP7674492B2 (ja) 2021-01-21 2025-05-09 アセンシア・ダイアベティス・ケア・ホールディングス・アーゲー 医療廃棄物を低減したバイオセンサーインサータ

Family Cites Families (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5390671A (en) * 1994-03-15 1995-02-21 Minimed Inc. Transcutaneous sensor insertion set
US6360888B1 (en) 1999-02-25 2002-03-26 Minimed Inc. Glucose sensor package system
DE10137375A1 (de) * 2001-07-31 2003-02-27 Infineon Technologies Ag Verwendung von Polybenzoxazolen (PBO) zum Kleben
JP2003072861A (ja) 2001-08-29 2003-03-12 Matsushita Electric Ind Co Ltd バイオセンサの包装方法
US6915147B2 (en) 2001-09-07 2005-07-05 Medtronic Minimed, Inc. Sensing apparatus and process
US7226461B2 (en) * 2002-04-19 2007-06-05 Pelikan Technologies, Inc. Method and apparatus for a multi-use body fluid sampling device with sterility barrier release
US7220387B2 (en) * 2002-07-23 2007-05-22 Apieron Biosystems Corp. Disposable sensor for use in measuring an analyte in a gaseous sample
WO2006015922A1 (en) 2004-08-10 2006-02-16 Novo Nordisk A/S A method of forming a sterilised sensor package and a sterilised sensor package
US20090048499A1 (en) * 2004-10-18 2009-02-19 Novo Nordisk A/S Sensor film for transcutaneous insertion and a method for making the sensor film
US8333714B2 (en) * 2006-09-10 2012-12-18 Abbott Diabetes Care Inc. Method and system for providing an integrated analyte sensor insertion device and data processing unit
US8133178B2 (en) * 2006-02-22 2012-03-13 Dexcom, Inc. Analyte sensor
US9072476B2 (en) * 2005-09-23 2015-07-07 Medtronic Minimed, Inc. Flexible sensor apparatus
EP1972275B1 (de) 2007-03-20 2015-10-28 Roche Diagnostics GmbH System zur in-vivo Messung einer Analytkonzentration
EP1972267A1 (de) 2007-03-20 2008-09-24 Roche Diagnostics GmbH System zur in-vivo Messung einer Analytkonzentration
EP2262543B1 (en) * 2008-04-10 2015-07-08 Abbott Diabetes Care Inc. Method and system for sterilizing an analyte sensor
US20100198034A1 (en) 2009-02-03 2010-08-05 Abbott Diabetes Care Inc. Compact On-Body Physiological Monitoring Devices and Methods Thereof
EP2266458A1 (de) * 2009-06-23 2010-12-29 Roche Diagnostics GmbH Sensor für in-vivo Messungen
EP2473963A4 (en) 2009-08-31 2014-01-08 Abbott Diabetes Care Inc MEDICAL DEVICES AND METHOD
US20130079675A1 (en) * 2011-09-23 2013-03-28 Orthosensor Insert measuring system having an internal sensor assembly
EP2579769A1 (de) * 2010-06-08 2013-04-17 Roche Diagnostics GmbH Analytsensor mit schlitzantenne
WO2012012135A2 (en) * 2010-06-30 2012-01-26 Edwards Lifesciences Corporation Analyte sensor
WO2012118872A2 (en) * 2011-02-28 2012-09-07 Abbott Diabetes Care Inc. Medical device inserters and processes of inserting and using medical devices
PL2599505T3 (pl) 2011-11-30 2014-10-31 Hoffmann La Roche Sposób i urządzenie sterylizacyjne do sterylizowania implantowanego czujnika
DK3831283T3 (da) * 2011-12-11 2023-05-30 Abbott Diabetes Care Inc Analytsensorindretninger, forbindelser og fremgangsmåder

Also Published As

Publication number Publication date
EP2982303A1 (en) 2016-02-10
WO2016020370A1 (en) 2016-02-11
CA2956116A1 (en) 2016-02-11
US20170143243A1 (en) 2017-05-25
CA2956116C (en) 2020-03-24
CN106535765B (zh) 2019-08-23
WO2016020370A9 (en) 2016-05-19
EP2982303B1 (en) 2017-02-22
US10939858B2 (en) 2021-03-09
DK2982303T3 (en) 2017-06-06
CN106535765A (zh) 2017-03-22
RU2017107091A (ru) 2018-09-07
SI2982303T1 (sl) 2017-05-31
RU2697996C2 (ru) 2019-08-21
RU2017107091A3 (pl) 2019-03-06

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