HRP20221130T1 - Sustav za detekciju statusa unutar sklopa uređaja za ubrizgavanje - Google Patents

Sustav za detekciju statusa unutar sklopa uređaja za ubrizgavanje Download PDF

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Publication number
HRP20221130T1
HRP20221130T1 HRP20221130TT HRP20221130T HRP20221130T1 HR P20221130 T1 HRP20221130 T1 HR P20221130T1 HR P20221130T T HRP20221130T T HR P20221130TT HR P20221130 T HRP20221130 T HR P20221130T HR P20221130 T1 HRP20221130 T1 HR P20221130T1
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Croatia
Prior art keywords
injection device
longitudinal axis
device assembly
assembly
sensors
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HRP20221130TT
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English (en)
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John William ADAMS
Eoin Patrick CONNAUGHTON
Toon Diels
Joseph Edward KATUIN
Sean Matthew PSZENNY
Miriam Elizabeth SAVAGE
Fiachra Sweeney
Stefan Mathieu Alfons Vaes
Adam Nathaniel WIESLER
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Eli Lilly And Company
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Publication of HRP20221130T1 publication Critical patent/HRP20221130T1/hr

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    • 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
    • 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
    • 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
    • A61M5/3129—Syringe barrels
    • A61M5/3137—Specially designed finger grip means, e.g. for easy manipulation of the syringe rod
    • 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
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31566—Means improving security or handling thereof
    • 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
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31576—Constructional features or modes of drive mechanisms for piston rods
    • 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
    • A61M5/32—Needles; 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
    • A61M5/3287—Accessories for bringing the needle into the body; 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
    • A61M5/44—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 cooling or heating the devices or media
    • 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
    • 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
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0219—Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
    • 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
    • A61M2005/206—With 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
    • A61M5/20—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
    • A61M2005/208—Release is possible only when device is pushed against the skin, e.g. using a trigger which is blocked or inactive when the device is not pushed against the skin
    • 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
    • A61M2205/13—General characteristics of the apparatus with means for the detection of operative contact with patient, e.g. lip sensor
    • 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
    • A61M2205/18—General characteristics of the apparatus with alarm
    • 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
    • A61M2205/33—Controlling, regulating or measuring
    • 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
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3317—Electromagnetic, inductive or dielectric measuring means
    • 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
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3368—Temperature
    • 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
    • A61M2205/3546—Range
    • A61M2205/3553—Range remote, e.g. between patient's home and doctor's office
    • 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
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • 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
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • 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
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/587—Lighting arrangements
    • 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
    • A61M2205/82—Internal energy supply devices
    • A61M2205/8275—Mechanical
    • A61M2205/8287—Mechanical operated by an external magnetic or electromagnetic field

Claims (16)

1. Sklop uređaja za ubrizgavanje koji sadrži: kućište (38) uređaja koje ima proksimalni kraj i distalni kraj, kućište koje definira unutrašnji volumen koji se proteže duž uzdužne osi između proksimalnog kraja i distalnog kraja, i proksimalni otvor na proksimalnom kraju kućišta povezan s unutrašnjim volumenom, kućište uređaja koje sadrži dio (37) koji je nadohvat korisniku, konfiguriran tako da se uhvati rukom korisnika, pri čemu se dio koji je nadohvat korisniku proteže na prvu radijalnu udaljenost prema van od uzdužne osi, i prema van prošireni krajnji dio (39) na proksimalnom kraju kućišta pored proksimalnog otvora, pri čemu se prema van prošireni krajnji dio proteže ka vanjskom od uzdužne osi na drugu radijalnu udaljenost, koja je veća od prve radijalne udaljenosti; sklop (22) šprica, barem djelomično raspoređen u okviru unutrašnjeg volumena, sklop šprica koji uključuje (i) cijev konfiguriranu za držanje lijeka, (ii) klip konfiguriran da klizi duž uzdužne osi unutar cijevi, i (iii) iglu za ubrizgavanje koja se proteže iz cijevi; pogonski mehanizam (24), konfiguriran za pomicanje sklopa šprica iz položaja za skladištenje u položaj za ubrizgavanje, i da pokreće klip proksimalno unutar cijevi tako da se izdaje lijek iz cijevi pri događaju izdavanja; i naznačen time što sklop uređaja sadrži jednu ili više glavnih tiskanih ploča (PCB), raspoređenih u okviru krajnjeg dijela kućišta uređaja proširenog prema van, pri čemu jedna ili više glavnih PCB definiraju otvor (83) kroz koji je najmanje dio sklopa šprica konfiguriran da prolazi tijekom događaja izdavanja, pri čemu se jedna ili više glavnih PCB protežu na radijalnu udaljenost od uzdužne osi koja je veća od prve radijalne udaljenosti, a jedna ili više glavnih PCB sadrže najmanje jednu bežičnu radio-frekvencijsku (RF) antenu i strujni krug za obradu, konfigurirane za bežični prijenos podataka na vanjski uređaj preko najmanje jedne bežične RF antene.
2. Sklop uređaja za ubrizgavanje prema patentnom zahtjevu 1, pri čemu je prva radijalna udaljenost 10 mm ili manje.
3. Sklop uređaja za ubrizgavanje prema patentnom zahtjevu 1, pri čemu je prva radijalna udaljenost 8 mm ili manje, a jedna ili više PCB se protežu 15 mm ili više radijalno prema van od uzdužne osi.
4. Sklop uređaja za ubrizgavanje prema patentnom zahtjevu 1, pri čemu jedna ili više glavnih PCB dodatno sadrži jedan ili više senzora postavljenih pored proksimalnog otvora, pri čemu je svaki senzor konfiguriran za detektiranje kontakta s tkivom kože.
5. Sklop uređaja za ubrizgavanje prema patentnom zahtjevu 4, pri čemu jedan ili više senzora sadrže mnoštvo senzora koji okružuju proksimalni otvor, pri čemu je svaki senzor konfiguriran za detektiranje kontakta s tkivom kože na osnovu izmjerene električne otpornosti, i svaki senzor se nalazi na radijalnoj udaljenosti prema van od uzdužne osi koja je veća od prve radijalne udaljenosti.
6. Sklop uređaja za ubrizgavanje prema patentnom zahtjevu 5, pri čemu se svaki senzor nalazi 10 mm ili više radijalno prema van od uzdužne osi.
7. Sklop uređaja za ubrizgavanje prema patentnom zahtjevu 5, pri čemu se svaki senzor nalazi 15 mm ili više radijalno prema van od uzdužne osi.
8. Sklop uređaja za ubrizgavanje prema patentnom zahtjevu 5 dodatno sadrži jednu ili više svjetlećih dioda (LEDs), integriranih s kućištem uređaja, pri čemu je strujni krug za obradu konfiguriran da osigura indikaciju korisniku, pokazujući koji pojedinačni senzori iz mnoštva senzora detektiraju kontakt s tkivom kože, i koji pojedinačni senzori iz mnoštva senzora ne detektiraju kontakt s tkivom kože, korištenjem jedne ili više LED dioda.
9. Sklop uređaja za ubrizgavanje prema patentnom zahtjevu 5, pri čemu je krug za obradu konfiguriran za prijenos na vanjski uređaj, putem bežičnog prijenosa podataka, podatke koji ukazuju koji pojedinačni senzori iz mnoštva senzora detektiraju kontakt s tkivom kože, a koji pojedinačni senzori iz mnoštva senzora ne detektiraju kontakt s tkivom kože.
10. Sklop uređaja za ubrizgavanje prema patentnom zahtjevu 1, koji dodatno sadrži jednu ili više sekundarnih PCB, koje su komunikacijski spojene s jednom ili više glavnih PCB, pri čemu se jedna ili više sekundarnih PCB pružaju paralelno s uzdužnom osi i uključuju jedan ili više senzora.
11. Sklop uređaja za ubrizgavanje prema patentnom zahtjevu 1 dodatno sadrži senzor temperature postavljen uz cijev, pri čemu je krug za obradu konfiguriran za procjenu temperature lijeka na osnovu izlaza senzora temperature.
12. Sklop uređaja za ubrizgavanje prema patentnom zahtjevu 1 dodatno sadrži senzor mikro-prekidača, koji je konfiguriran za utvrđivanje šprica li sklop u najmanje jednom od položaja za skladištenje, položaja za ubrizgavanje i uvučenog položaja.
13. Uređaj za ubrizgavanje prema patentnom zahtjevu 12, pri čemu je senzor mikro-prekidača raspoređen na jednoj ili više glavnih PCB.
14. Sklop uređaja za ubrizgavanje prema patentnom zahtjevu 1 dodatno sadrži: magnet, konfiguriran za održavanje fiksne aksijalne udaljenosti od klipa dok klizi duž uzdužne osi unutar cijevi; i prvi magnetometar raspoređen na jednoj ili više glavnih PCB, konfiguriran za emitiranje prvog izlaznog signala na osnovu detektiranog magnetskog polja magneta; pri čemu je krug za obradu konfiguriran za procjenu aksijalnog položaja klipa duž uzdužne osi unutar cijevi na osnovu barem djelomično prvog izlaznog signala prvog magnetometra.
15. Sklop uređaja za ubrizgavanje prema patentnom zahtjevu 14, koji dodatno sadrži najmanje drugi magnetometar, raspoređen odvojeno od jedne ili više glavnih PCB, a uz cijev, drugi magnetometar konfiguriran za emitiranje drugog izlaznog signala na osnovu detektiranog magnetnog polja magneta, pri čemu je krug za obradu konfiguriran tako da procijeni aksijalni položaj klipa i na osnovu prvog izlaznog signala prvog magnetometra i na osnovu drugog izlaznog signala drugog magnetometra.
16. Sklop uređaja za ubrizgavanje prema patentnom zahtjevu 15, pri čemu se drugi magnetometar nalazi radijalno bliže uzdužnoj osi nego prvi magnetometar.
HRP20221130TT 2018-10-03 2019-09-27 Sustav za detekciju statusa unutar sklopa uređaja za ubrizgavanje HRP20221130T1 (hr)

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US201862740539P 2018-10-03 2018-10-03
US201962818308P 2019-03-14 2019-03-14
EP19789824.0A EP3860687B1 (en) 2018-10-03 2019-09-27 Status sensing systems within an injection device assembly
PCT/US2019/053438 WO2020072299A1 (en) 2018-10-03 2019-09-27 Status sensing systems within an injection device assembly

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CN (2) CN115120814A (hr)
AU (3) AU2019351804B2 (hr)
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