DK3199121T3 - Funktionel medicinsk pakning og medicinsk indretning til indsætning af mindst ét undersystem i en vært - Google Patents

Funktionel medicinsk pakning og medicinsk indretning til indsætning af mindst ét undersystem i en vært Download PDF

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Publication number
DK3199121T3
DK3199121T3 DK16153330.2T DK16153330T DK3199121T3 DK 3199121 T3 DK3199121 T3 DK 3199121T3 DK 16153330 T DK16153330 T DK 16153330T DK 3199121 T3 DK3199121 T3 DK 3199121T3
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Denmark
Prior art keywords
sterile container
package
subsystem
functional medical
host
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DK16153330.2T
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English (en)
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Frank Deck
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Hoffmann La Roche
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Publication of DK3199121T3 publication Critical patent/DK3199121T3/da

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150305—Packages specially adapted for piercing devices or blood sampling devices
    • 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
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/002—Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
    • B65B55/02—Sterilising, e.g. of complete packages
    • B65B55/04—Sterilising wrappers or receptacles prior to, or during, packaging
    • 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
    • A61B2050/005—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers with a lid or cover
    • A61B2050/0065—Peelable cover
    • 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
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/14—Devices for taking samples of blood ; Measuring characteristics of blood in vivo, e.g. gas concentration within the blood, pH-value of blood
    • A61B5/1405—Devices for taking blood samples
    • A61B5/1411—Devices for taking blood samples by percutaneous method, e.g. by lancet
    • 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, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1468—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means
    • A61B5/1473—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150015—Source of blood
    • A61B5/15003—Source of blood for venous or arterial blood
    • 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
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/0007—Special media to be introduced, removed or treated introduced into the body
    • 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
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/04—Liquids
    • A61M2202/0413—Blood
    • 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
    • A61M2207/00—Methods of manufacture, assembly or production

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Manufacturing & Machinery (AREA)
  • Physics & Mathematics (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Mechanical Engineering (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Packages (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Surgical Instruments (AREA)
  • External Artificial Organs (AREA)

Claims (16)

1. Funktionel medicinsk pakning (220), omfattende a) mindst én steril beholder (152) aftageligt modtaget inde i pakningen (110); og b) mindst ét undersystem (202) konfigureret til at blive mindst delvist indsat i en vært, hvilket undersystem (202) modtages i den sterile beholder (152); - hvor den sterile beholder (152) omfatter mindst én indføringsudgangsåbning (168) til undersystemet (202), - hvor indføringsudgangsåbningen (168) er lukket af en forseglingsmembran (118) på indføringsudgangsåbningen (168), kendetegnet ved at, c) pakningen (110) i hvilken den sterile beholder (152) er fjernbart modtaget i en engangsemballage (110), og hvor, - forseglingsmembranen (118) af undersystemet er fastgjort til engangsemballagen (110), således at forseglingsmembranen (118) automatisk trækkes af når den sterile beholder (152) fjernes fra engangsemballagen (110).
2. Funktionel medicinsk pakning (220) ifølge det foregående krav, hvor undersystemet (202) er valgt fra gruppen bestående af: en analytsensor til påvisning af mindst én analyt i et legemsvæv; en medikamentindretning (204) til at tilvejebringe mindst ét medikament til værten.
3. Funktionel medicinsk pakning (220) ifølge det foregående krav, hvor medikamentindretningen omfatter kanylen (206) og en indsætningsnål (208) der er fjernbart modtagelig i kanylen (206).
4. Funktionel medicinsk pakning (220) ifølge et hvilket som helst af de foregående krav, hvor den sterile beholder (152) omfatter mindst ét sterilt beholderhus (154) med indføringsudgangsåbningen (168), og hvor den sterile beholder (152) yderligere omfatter mindst én drivåbning (170) til at muliggøre en aktuator af et indføringselement (222) til at trænge ind i den sterile beholder (152) og til at indgribe med undersystemet (202) til indsætning i værten.
5. Funktionel medicinsk pakning (220) ifølge det foregående krav, hvor drivåbningen (170) er tætnet af mindst et drivtætningselement (182).
6. Funktionel medicinsk pakning (220) ifølge det foregående krav, hvor drivtætningselementet (182) er konfigureret til at blive skåret åben.
7. Funktionel medicinsk pakning (220) ifølge det foregående krav, hvor drivtætningselementet (182) er konfigureret til at blive skåret åben af mindst én drivarm (240) af indføringselementet (222) og/eller af en skæremekanisme af indføringselementet (222).
8. Funktionel medicinsk pakning (220) ifølge et hvilket som helst af de foregående krav, hvor engangsemballagen (110) omfatter en engangsemballageåbning (116) gennem hvilken den sterile beholder (152) er fjernbar fra engangsemballagen (110).
9. Funktionel medicinsk pakning (220) ifølge det foregående krav, hvor engangsemballageåbningen (116) er tætnet af mindst ét tætningselement.
10. Funktionel medicinsk pakning (220) ifølge et hvilket som helst af de foregående krav, yderligere omfattende mindst én kropholder (192) konfigureret til fastgørelse på værtens hud.
11. Funktionel medicinsk pakning (220) ifølge det foregående krav, hvor den sterile beholder (152) er fastgjort til kropholderen (192).
12. Funktionel medicinsk pakning (220) ifølge et hvilket som helst af de to foregående krav, hvor den sterile beholder (152) og kropholderen (192) er fjernbare fra engangsemballagen (110) som en enhed.
13. Medicinsk indretning (224) til indsætning af mindst ét undersystem (202) i en vært, hvilken medicinske indretning (224) omfatter: - mindst en funktionel medicinsk pakning (220) ifølge et hvilket som helst af de foregående krav; og - mindst ét indsætningselement (222) konfigureret til indsætning af undersystemet (202) ind i værten.
14. Fremgangsmåde til fremstilling af den funktionelle medicinske pakning (220) ifølge et hvilket som helst af de foregående krav med henvisning til en funktionel medicinsk pakning (220), hvilken fremgangsmåde omfatter at: - tilvejebringe engangsemballagen (110); - tilvejebringe den sterile beholder (152) med undersystemet (202) modtaget deri, med forseglingsmembranen (118) der lukker indføringsudgangsåbningen (168); - fjernbart at modtage den sterile beholder (152) inde i engangsemballagen (110); og - fastgøre forseglingsmembranen (118) til engangsemballagen (110).
15. Fremgangsmåden ifølge det foregående krav, hvor fremgangsmåden yderligere omfatter mindst ét sterilisationstrin til sterilisering af den sterile beholder (152) med undersystemet (202) modtaget deri.
16. Fremgangsmåde til at opsamle et undersystem (202) konfigureret til at blive mindst delvist indsat i en vært af et indsætningselement (222), idet fremgangsmåden omfatter at: I. tilvejebringe mindst en funktionel medicinsk pakning (220) ifølge et hvilket som helst af de foregående krav med henvisning til en funktionel medicinsk pakning (220); II. forbinde mindst ét indsætningselement (222) til den funktionelle medicinske pakning (220), hvor indføringselementet (222) indgriber med den sterile beholder (152) af den funktionelle medicinske pakning (220); III. fjerne indføringselementet (222) fra engangsemballagen (110) af den funktionelle medicinske pakning (220), hvor den sterile beholder (152) forbliver i indgreb med indføringselementet (222) og hvor forseglingsmembranen (118) trækkes af fra indføringsudgangsåbningen (168) af den sterile beholder (152) under fjernelse af indføringselementet (222) fra engangsemballagen (110).
DK16153330.2T 2016-01-29 2016-01-29 Funktionel medicinsk pakning og medicinsk indretning til indsætning af mindst ét undersystem i en vært DK3199121T3 (da)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP16153330.2A EP3199121B1 (en) 2016-01-29 2016-01-29 Functional medical package and medical device for inserting at least one subsystem into a host

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DK3199121T3 true DK3199121T3 (da) 2018-12-10

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US (1) US11426248B2 (da)
EP (1) EP3199121B1 (da)
JP (1) JP6914948B2 (da)
AU (1) AU2017213125B2 (da)
BR (1) BR112018008408A2 (da)
DK (1) DK3199121T3 (da)
ES (1) ES2698519T3 (da)
RU (1) RU2719948C2 (da)
WO (1) WO2017129757A1 (da)

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WO2017129757A1 (en) 2017-08-03
RU2018129955A (ru) 2020-03-03
JP6914948B2 (ja) 2021-08-04
ES2698519T3 (es) 2019-02-05
EP3199121B1 (en) 2018-08-22
JP2019508104A (ja) 2019-03-28
EP3199121A1 (en) 2017-08-02
BR112018008408A2 (pt) 2018-10-30
AU2017213125A1 (en) 2018-05-10
RU2018129955A3 (da) 2020-03-03
US11426248B2 (en) 2022-08-30
US20180344422A1 (en) 2018-12-06
RU2719948C2 (ru) 2020-04-23
AU2017213125B2 (en) 2018-11-15

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