DK3099355T3 - Terapeutisk produktfrigivelsesindretning - Google Patents

Terapeutisk produktfrigivelsesindretning Download PDF

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Publication number
DK3099355T3
DK3099355T3 DK15708021.9T DK15708021T DK3099355T3 DK 3099355 T3 DK3099355 T3 DK 3099355T3 DK 15708021 T DK15708021 T DK 15708021T DK 3099355 T3 DK3099355 T3 DK 3099355T3
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Prior art keywords
cartridge
therapeutic product
release
device body
reservoir
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DK15708021.9T
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English (en)
Inventor
Julian Shapley
Matthew Powell
Ceri Clatworthy
Joseph Cefai
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Cellnovo Ltd
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Publication of DK3099355T3 publication Critical patent/DK3099355T3/da

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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
    • 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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • 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
    • A61B5/14532—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 for measuring glucose, e.g. by tissue impedance measurement
    • 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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on 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
    • 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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16831—Monitoring, detecting, signalling or eliminating infusion flow anomalies
    • 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
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2033—Spring-loaded one-shot injectors with or without automatic needle insertion
    • 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
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31545—Setting modes for dosing
    • A61M5/31546—Electrically operated dose setting, e.g. input via touch screen or plus/minus buttons
    • 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
    • A61M5/50—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 having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
    • 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
    • A61M5/50—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 having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
    • A61M5/5086—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 having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile for indicating if defective, used, tampered with or unsterile
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
    • G16H20/17—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
    • 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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M2005/14268—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body with a reusable and a disposable component
    • 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
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/2073—Automatic 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
    • 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
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M2005/2433—Ampoule fixed to ampoule holder
    • A61M2005/2437—Ampoule fixed to ampoule holder by clamping means
    • A61M2005/244—Ampoule fixed to ampoule holder by clamping means by flexible clip
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/12—General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit
    • A61M2205/121—General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit interface between cassette and base
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/12—General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit
    • A61M2205/123—General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit with incorporated reservoirs
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/27—General characteristics of the apparatus preventing use
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/27—General characteristics of the apparatus preventing use
    • A61M2205/273—General characteristics of the apparatus preventing use preventing reuse, e.g. of disposables
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3576—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver
    • A61M2205/3584—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver using modem, internet or bluetooth
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3576—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver
    • A61M2205/3592—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver using telemetric means, e.g. radio or optical transmission
    • 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
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/20—Blood composition characteristics
    • A61M2230/201—Glucose concentration

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Vascular Medicine (AREA)
  • Medical Informatics (AREA)
  • Physics & Mathematics (AREA)
  • Chemical & Material Sciences (AREA)
  • Primary Health Care (AREA)
  • Medicinal Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Pathology (AREA)
  • Surgery (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Optics & Photonics (AREA)
  • Emergency Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • External Artificial Organs (AREA)

Claims (11)

1. Terapeutisk produktfrigivelsesindretning (2) omfattende: en indretningskrop (21); en patron (26) til at holde et terapeutisk produkt; en indgrebsstruktur (420) til udloseligt indgreb af patronen (26) med indret-ningskroppen (21); en fejldetektor (630) til detektering af en fejl ved frigivelsen af det terapeutiske produkt fra patronen (26); og en frigivelsesudloser, der reagerer pa detektering af en fejl for at fa indgrebs-strukturen til atfrigive patronen (26) fra indretningskroppen (21).
2. Terapeutisk produktfrigivelsesindretning (2) ifolge krav 1, hvor patronen (26) omfat-ter et reservoir (27), som indeholder det terapeutiske produkt, og en pumpeindretning (29) til pumpning af det terapeutiske produkt fra reservoiret (27) til patiënten.
3. Terapeutisk produktfrigivelsesindretning (2) ifolge krav 2, hvor indretningskroppen (21) omfatter et forspaendingselement (450), der presser mod reservoiret (27) af patronen (26), nar patronen (26) er i indgreb med indretningskroppen (21); og den kraft, der udoves af forspaendingselementet (450) pa patronen (26), bevirker, at patronen (26) udstodes vaekfra indretningskroppen (21), nar indgrebsstrukturen (420) frigiver patronen (26) fra indretningskroppen (21).
4. Terapeutisk produktfrigivelsesindretning (2) ifolge krav 3, hvor forspaendingselementet omfatter en fjeder (450).
5. Terapeutisk produktfrigivelsesindretning (2) ifolge krav 1, hvor indgrebsstrukturen omfatter ét eller fiere forste indgrebselementer (420) pa den ene eller den anden af indretningskroppen (21) og patronen (26), idet de forste indgrebselementer (420) kan ga i indgreb med ét eller fiere tilsvarende andre indgrebselementer (410) pa den anden af indretningskroppen (21) og patronen (26).
6. Terapeutisk produktfrigivelsesindretning (2) ifolge krav 5, hvor de forste indgrebs-elementer er clips (420), og de andre indgrebselementer er flapper (410).
7. Terapeutisk produktfrigivelsesindretning (2) ifolge krav 5, hvor indgrebsstrukturen omfatter et frigivelseselement, som er bevaegeligt mellem en fastholdelsesposition, i hvilken de forste indgrebselementer (420) er i stand til at ga i indgreb med de andre indgrebselementer (410), og en frigivelsesposition, i hvilken de forste indgrebselementer ikke er i stand til at ga i indgreb med de andre indgrebselementer, og et wireele-ment (440), der er deformerbart som reaktion pa en pafort elektrisk strom for at bevae-ge frigivelseselementet fra fastholdelsespositionen til frigivelsespositionen; og frigivelsesudloseren reagerer pa detekteringen af fejlen ved at pafore en elektrisk strom pa wireelementet og derved deformere wireelementet (440).
8. Terapeutisk produktfrigivelsesindretning (2) ifolge krav 7, hvor indgrebsstrukturen omfatter en fjeder (430), der forspaender frigivelseselementet mod fastholdelsespositionen, idet wireelementet (440) virker mod forspaendingen som reaktion pa den paforte elektriske strom og bevaeger frigivelseselementet ind i frigivelsespositionen.
9. Terapeutisk produktfrigivelsesindretning (2) ifolge krav 7 eller 8, som omfatter en frigivelsesaktuator (460), der reagerer pa brugermanipulation for at bevaege frigivelseselementet fra fastholdelsespositionen til frigivelsespositionen.
10. Terapeutisk produktfrigivelsesindretning (2) ifolge krav 1, hvorfejldetektoren (630) detekterer en fejl, nar leveringshastigheden af det terapeutiske produkt overstiger en forudbestemt taerskelhastighed.
11. Terapeutisk produktfrigivelsesindretning (2) ifolge krav 3, hvorforspaendingsele-mentet presser mod et bevaegeligt element i reservoiret (27), og fejldetektoren (630) omfatter en forskydningssensor til detektering af en position af det bevaegelige element og et detektionskredslob til detektering af en fejl, nar positionen af det bevaegelige element (23) aendres med en hastighed over en forudbestemt taerskelhastighed.
DK15708021.9T 2014-01-30 2015-01-30 Terapeutisk produktfrigivelsesindretning DK3099355T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB1401587.9A GB2525149A (en) 2014-01-30 2014-01-30 Therapeutic product delivery device
PCT/GB2015/050251 WO2015114373A1 (en) 2014-01-30 2015-01-30 Therapeutic product delivery device

Publications (1)

Publication Number Publication Date
DK3099355T3 true DK3099355T3 (da) 2018-06-25

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DK15708021.9T DK3099355T3 (da) 2014-01-30 2015-01-30 Terapeutisk produktfrigivelsesindretning

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US (2) US10449290B2 (da)
EP (1) EP3099355B1 (da)
JP (1) JP6523307B2 (da)
KR (1) KR101869769B1 (da)
CN (1) CN106029126B (da)
CA (1) CA2935692C (da)
DK (1) DK3099355T3 (da)
GB (1) GB2525149A (da)
HK (1) HK1216400A1 (da)
MX (1) MX2016009551A (da)
TW (1) TW201531316A (da)
WO (1) WO2015114373A1 (da)

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MX2016009551A (es) 2016-10-21
JP2017504424A (ja) 2017-02-09
CN106029126B (zh) 2019-06-28
GB2525149A (en) 2015-10-21
CA2935692A1 (en) 2015-08-06
WO2015114373A1 (en) 2015-08-06
EP3099355B1 (en) 2018-03-14
CN106029126A (zh) 2016-10-12
KR101869769B1 (ko) 2018-06-21
CA2935692C (en) 2022-05-24
HK1216400A1 (zh) 2016-11-11
GB201401587D0 (en) 2014-03-19
US20160339170A1 (en) 2016-11-24
JP6523307B2 (ja) 2019-05-29
US20200101218A1 (en) 2020-04-02
US10449290B2 (en) 2019-10-22
KR20160113253A (ko) 2016-09-28
EP3099355A1 (en) 2016-12-07
TW201531316A (zh) 2015-08-16

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