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
SI3909506T1 (sl) 2016-02-05 2023-09-29 F. Hoffmann - La Roche Ag Medicinski pripomoček za odkrivanje vsaj enega analita v telesni tekočini
RS66283B1 (sr) 2016-02-05 2025-01-31 Hoffmann La Roche Medicinski uređaj za detekciju najmanje jednog analita u telesnoj tečnosti
CN110612061A (zh) * 2017-05-09 2019-12-24 安晟信医疗科技控股公司 用于连续葡萄糖监测器的传感器组件装置和方法
DE202018006862U1 (de) 2017-12-21 2023-11-16 Roche Diabetes Care Gmbh Medizinisches System
ES2980471T3 (es) * 2019-07-04 2024-10-01 Hoffmann La Roche Aguja de implantación para insertar un elemento insertable por vía subcutánea en un tejido corporal
US11602373B2 (en) 2019-08-20 2023-03-14 Ascensia Diabetes Care Holdings Ag Biosensor inserter apparatus and methods
US11707297B2 (en) 2019-08-20 2023-07-25 Ascensia Diabetes Care Holdings Ag Continuous analyte monitor 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
WO2022044017A1 (en) 2020-08-26 2022-03-03 Tingo Medical Ltd. Continuous glucose sensor and mounting assembly
KR20230062816A (ko) 2020-09-07 2023-05-09 어센시아 다이어비티즈 케어 홀딩스 아게 연속 피분석물 모니터링 디바이스의 베이스 유닛에 전자 유닛의 결합을 가능하게 하는 방법 및 장치
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
CN116801807A (zh) 2021-01-21 2023-09-22 安晟信医疗科技控股公司 可穿戴持续分析物测量装置、生物传感器插入器和使用方法

Family Cites Families (24)

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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
JP2008508971A (ja) 2004-08-10 2008-03-27 ノボ・ノルデイスク・エー／エス 滅菌されたセンサパッケージの形成方法及び滅菌されたセンサパッケージ
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
PL1972275T3 (pl) 2007-03-20 2016-04-29 Hoffmann La Roche Układ do pomiaru in vivo stężenia analitu
EP1972267A1 (de) 2007-03-20 2008-09-24 Roche Diagnostics GmbH System zur in-vivo Messung einer Analytkonzentration
EP2982383B1 (en) * 2008-04-10 2019-05-15 Abbott Diabetes Care, Inc. Method for sterilizing an analyte sensor
US9402544B2 (en) 2009-02-03 2016-08-02 Abbott Diabetes Care Inc. Analyte sensor and apparatus for insertion of the sensor
EP2266458A1 (de) * 2009-06-23 2010-12-29 Roche Diagnostics GmbH Sensor für in-vivo Messungen
WO2011025549A1 (en) 2009-08-31 2011-03-03 Abbott Diabetes Care Inc. Medical devices and methods
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CN102917636A (zh) * 2010-06-08 2013-02-06 霍夫曼-拉罗奇有限公司 具有缝隙天线的分析物传感器
EP2588624A2 (en) * 2010-06-30 2013-05-08 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
EP2599505B1 (de) 2011-11-30 2014-05-14 Roche Diagniostics GmbH Verfahren und Sterilisationsvorrichtung zum Sterilisieren eines implantierbaren Sensors
WO2013090215A2 (en) * 2011-12-11 2013-06-20 Abbot Diabetes Care Inc. Analyte sensor devices, connections, and methods

Also Published As

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

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