DK2099384T3 - Indføringsanordning og fremgangsmåde til indføring af et subkutant indførligt element i et legeme - Google Patents

Indføringsanordning og fremgangsmåde til indføring af et subkutant indførligt element i et legeme Download PDF

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DK2099384T3
DK2099384T3 DK07827427.1T DK07827427T DK2099384T3 DK 2099384 T3 DK2099384 T3 DK 2099384T3 DK 07827427 T DK07827427 T DK 07827427T DK 2099384 T3 DK2099384 T3 DK 2099384T3
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inserter
well
penetrating
cartridge
cannula
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DK07827427.1T
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English (en)
Inventor
Ofer Yodfat
Gavriel J Iddan
Avraham Neta
Ruthy Kaidar
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Hoffmann La Roche
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring 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
    • A61B5/14503Measuring 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 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring 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
    • A61B5/14532Measuring 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846Arrangements 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
    • A61B5/6847Arrangements 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
    • A61B5/6848Needles
    • 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150015Source of blood
    • A61B5/150022Source of blood for capillary blood or interstitial fluid
    • 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/002Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics
    • A61M2005/004Magazines with multiple needles directly inserted into an injection or infusion device, e.g. revolver-like magazines
    • 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A61M2005/1581Right-angle needle-type devices
    • 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A61M2005/1585Needle inserters
    • 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/2073Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically preventing premature release, e.g. by making use of a safety lock
    • 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3287Accessories for bringing the needle into the body; Automatic needle insertion

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Pathology (AREA)
  • Surgery (AREA)
  • Molecular Biology (AREA)
  • Medical Informatics (AREA)
  • Biophysics (AREA)
  • Optics & Photonics (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Emergency Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Claims (12)

1. Anordning, der omfatter: en anordning (105) til indgivelse af et terapeutisk fluid i en patients legeme og/eller til detektering af en kropsanalysand, hvilken anordning har en åbning konfigureret som en brønd (107); og en indføringsanordning (100), der omfatter: et hus, hvori der er: mindst én penetreringspatron (150), der omfatter et penetreringselement (111) og et subkutant indførligt element (110); og en manuelt aktiverbar forskydningsmekanisme (507), der efter aktivering er i stand til at trække penetreringspatronen (111) frem mod anordningen til indgivelse og/eller detektering, hvor fremtrækning resulterer i indføring af mindst det subkutant indf ørlige element (110) i et subkutant rum af legemet; hvor indføringsanordningen (100) er egnet til indføring af mindst det subkutant indf ørlige element (110) i det subkutane rum af legemet via åbningen tilvejebragt i anordningen til indgivelse og/eller detektering, og hvor indføringsanordningen er egnet til at muliggøre udføring af penetreringselementet (111) fra det subkutane rum via åbningen; kendetegnet ved, at indføringsanordningen endvidere omfatter en positionsindstillingsfunktion, der er en sikkerhedsmekanisme (401) til at forhindre forskydningsmekanismen i at blive aktiveret, når penetreringspatronen (150) ikke flugter med brønden (107), og som kun muliggør aktivering af forskydningsmekanismen, når indføringsanordningen (100) har placeret i en forudbestemt position i forhold til anordningen (105) til indgivelse og/eller detektering, hvilken sikkerhedsmekanisme (401) indbefatter indsnitsriller (101) på en øvre overflade af anordningen (105) og matchende positioneringsfremspring (101) på en nedre overflade af indføringsanordningens (100) hus, hvor korrekt positionering af positioneringsfremspringene (301) inde i indsnitsrillerne (101) muliggør bevægelse af en sikkerheds stang (518) for at muliggøre fremføring af penetreringspatronen (150), når penetreringspatronen (150) flugter med brønden (107), hvor sikkerheds stangen (518) er låst i en sikkerhedsposition, der forhindrer aktivering af forskydningsmekanismen, når positioneringsfremspringene (301) ikke er korrekt placeret inde i indsnitsrilleme (101).
2. Anordning som defineret i krav 1, hvor huset er forsynet med mindst ét fremspring (301); og anordningen (105) til indgivelse og/eller til detektering er forsynet med en tilsvarende mindst én fordybning (101), der omgiver brønden (107), således at, efter indføring af det mindst ene fremspring (301) i den mindst ene fordybning (101), penetreringspatronen (150) flugter med brønden (107).
3. Anordning som defineret i krav 1, hvor det subkutant indførlige element (110) er en kanyle til indgivelse af det terapeutiske fluid.
4. Anordning som defineret i krav 1, hvor det subkutant indf ørlige element (110) er en sensor til måling af kropsanalysand.
5. Anordning som defineret i krav 1, hvor brønden (107) er drejbar.
6. Anordning som defineret i krav 1, hvor indføringsanordningen (110) endvidere omfatter et tilbagetrækningsmiddel (505), der er operativt sammenkoblet med penetreringspatronen (150) og i stand til automatisk at trække penetreringselementet (111) tilbage fra det subkutane rum, mens det subkutant indf ørlige element (110) forbliver inde i det subkutane rum.
7. Anordning som defineret i krav 1, hvor penetreringspatronen (150) endvidere omfatter en tætningskappe (118), der kan modtages i brønden (107); tætningskappen (118) er tilpasset til at tætne brønden (107), efter at er det mindst subkutant indf ørlige element (110) er indført, og efter at penetreringselementet (111) er ført ud.
8. Anordning som defineret i krav 1, hvor indføringsanordningen (110) endvidere omfatter en manuelt aktiverbar knap (330) til aktivering af forskydningsmekanismen; og en fejludløsningssikkerhedsmekanisme (402) til at forhindre utilsigtet aktivering af knappen (330).
9. Anordning som defineret i krav 1, hvor penetreringselementet (111) indbefatter: en indføringsende til penetrering af det subkutane væv; og en gribedel (116) placeret modsat indføringsenden; hvor gribedelen (116) gør det muligt for penetreringselementet (111) at blive ført frem og trukket tilbage.
10. Anordning som defineret i krav 1, hvor forskydningsmekanismen omfatter en krumtap (312), der kan aktiveres ved hjælp af et tandhjul.
11. Anordning som defineret i krav 1, hvor indføringsanordningen (110) endvidere omfatter en tromle (815), der kan forfyldes med en flerhed af penetrerende patroner (150); tromlen (815) er forsynet med en flerhed af kamre (817) til modtagelse af flerheden af penetrerende patroner (150) og tromlen (815) kan forskydes i forhold til huset for således at justere et kammer efter en længdeakse af indføringsanordningen og for at muliggøre fremtrækning af penetreringspatronen modtaget i kammeret.
12. Anordning som defineret i krav 1, hvor anordningen til indgivelse og/eller detektering kan klæbes fast på huden.
DK07827427.1T 2006-11-28 2007-11-26 Indføringsanordning og fremgangsmåde til indføring af et subkutant indførligt element i et legeme DK2099384T3 (da)

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Application Number Priority Date Filing Date Title
US86134506P 2006-11-28 2006-11-28
PCT/IL2007/001454 WO2008065646A1 (en) 2006-11-28 2007-11-26 An insertion device and method for inserting a subcutaneously insertable element into a body

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DK2099384T3 true DK2099384T3 (da) 2018-10-08

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US (1) US8696570B2 (da)
EP (1) EP2099384B1 (da)
DK (1) DK2099384T3 (da)
ES (1) ES2690306T3 (da)
WO (1) WO2008065646A1 (da)

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