HRP20231380T1 - Modul sistema za detektiranje doze za uređaj za davanje lijeka - Google Patents

Modul sistema za detektiranje doze za uređaj za davanje lijeka Download PDF

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HRP20231380T1
HRP20231380T1 HRP20231380TT HRP20231380T HRP20231380T1 HR P20231380 T1 HRP20231380 T1 HR P20231380T1 HR P20231380T T HRP20231380T T HR P20231380TT HR P20231380 T HRP20231380 T HR P20231380T HR P20231380 T1 HRP20231380 T1 HR P20231380T1
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module
light guide
wall
ring
proximal
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HRP20231380TT
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Benjamin David BAUER
Timothy Mark BLUM
Roy Howard Byerly
Andrea CONCU
Marco CORTINOVIS
Paolo DEGAN
Jared Alden Judson
Rossano Claudio MASSARI
Kimberly Ann RINGENBERGER
Giorgio Maria SARDO
Amin SEDIGHIAMIRI
Marco Vergani
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Eli Lilly And Company
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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
    • A61M5/31—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
    • A61M5/31568—Means keeping track of the total dose administered, e.g. since the cartridge was inserted
    • 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
    • A61M5/31525—Dosing
    • A61M5/31528—Dosing by means of rotational movements, e.g. screw-thread mechanisms
    • 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
    • A61M5/31548—Mechanically operated dose setting member
    • A61M5/3155—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe
    • A61M5/31551—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe including axial movement of dose setting member
    • 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
    • A61M5/31583—Constructional features or modes of drive mechanisms for piston rods based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod
    • A61M5/31585—Constructional features or modes of drive mechanisms for piston rods based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod performed by axially moving actuator, e.g. an injection button
    • 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
    • A61M5/3159—Dose expelling manners
    • A61M5/31593—Multi-dose, i.e. individually set dose repeatedly administered from the same medicament reservoir
    • 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
    • A61M2205/3306—Optical 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
    • A61M2205/3317—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
    • A61M2205/3327—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
    • A61M2205/60—General characteristics of the apparatus with identification 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
    • 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

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Claims (26)

1. Modul (82, 400, 600, 800) za detektiranje doze za uklonjivo pričvršćivanje na gumb (402, 470, 480, 502, 601, 712) za doziranje uređaja za davanje lijeka, gumb za doziranje koje ima bočnu stranu (404, 472, 482, 504, 604) gumba, uređaj koji sadrži detektiranu komponentu (152, 902, 706) prstena koji se može rotirati tijekom izdavanja doze, pri čemu navedeni modul sadrži: kućište koje uključuje proksimalni zid (412, 626, 802), distalni zid (414, 606, 806), i bočni zid (416, 604, 804) modula koji se proteže između njih oko uzdužne osi modula da bi definirao unutrašnji odjeljak, bočni zid modula koji se proteže distalno izvan distalnog zida, pri čemu distalni zid definira mnoštvo udubljenja (476, 623, 842) raspoređenih pod jednakim kutem jedni u odnosu na druge, kućište koje je konfigurirano tako da se spaja oko navedene bočne strane gumba; i sklop (610, 810) elektronike koji sadrži procesor i mnoštvo senzora (160, 906) funkcionalno povezanih s procesorom, pri čemu su senzori konfigurirani tako da detektiraju kružno kretanje detektirane komponente prstena da bi generirali signale položaja, a procesor je konfiguriran tako da prima signale položaja kako bi odredio podatke koji ukazuju na količinu isporučene doze na osnovu signala položaja, pri čemu detektirana komponenta (152, 902, 706) prstena sadrži bipolarni magnetni prsten, a senzori (160, 906) sadrže magnetne senzore postavljene u raspored tako da preklapaju vanjski obujam navedenog bipolarnog magnetnog prstena.
2. Modul prema patentnom zahtjevu 1, pri čemu navedeni magnetni senzori (160, 906) sadrže pet ili šest magnetnih senzora.
3. Modul prema patentnom zahtjevu 1, pri čemu kućište uključuje svjetlovodni element (685, 849), i distalni zid (414, 606, 806) koji definira otvor (684, 836) stupa, svjetlovodni element koji uključuje svjetlovodni stup (853) koji se proksimalno proteže kroz navedeni otvor stupa izvan magnetnih senzora (160, 906), pri čemu sklop elektronike (610, 810) sadrži senzor (680) za identifikaciju boje, koji je postavljen preko svjetlovodnog stupa i aksijalno razmaknut od njega, pri čemu je navedeni senzor za identifikaciju boje funkcionalno povezan s procesorom i konfiguriran tako da emitira i/ili detektira boju navedenog gumba za doziranje nakon odbijanja svjetlosti od gumba za doziranje.
4. Modul prema patentnom zahtjevu 3, pri čemu je svjetlovodni element (685, 849) fiksno pričvršćen na distalni zid.
5. Modul prema patentnom zahtjevu 4, pri čemu svjetlovodni element (685, 849) uključuje jedan ili više stupova (859) za pričvršćivanje radijalno razmaknutih od svjetlovodnog stupa (853), pri čemu distalni zid uključuje jednu ili više otvora (863) za pričvršćivanje, gdje svaka od jedne ili više otvora za pričvršćivanje prima odgovarajući od jednog ili više stupova za pričvršćivanje.
6. Modul prema patentnom zahtjevu 1, sklop (610, 810) elektronike dalje sadrži bateriju (621, 861) koja je funkcionalno povezana s procesorom, i aksijalno kompresibilni potporni element (864) baterije koji je trenjem u kontaktu s proksimalnom stranom baterije.
7. Modul prema patentnom zahtjevu 6, pri čemu navedena baterija (610, 810) ima površinu poprečnog presjeka u odnosu na radijalni položaj navedenih senzora i aksijalno je razmaknuta od navedenih senzora da bi osigurala zaštitu senzora.
8. Modul prema patentnom zahtjevu 1, dalje sadrži prekidački sistem (620, 820) konfiguriran tako da poveća snagu sklopa elektronike, pri čemu je proksimalni zid aksijalno pokretan u odnosu na bočni zid modula i distalni zid da aktivira sistem prekidača silom manjom od sile potrebne za isporuku doze od aktiviranja uređaja.
9. Modul prema patentnom zahtjevu 8, pri čemu prekidački sistem (820) sadrži najmanje jedan set nagnutog kontaktnog kraka (822), koji se proteže između sklopa elektronike i proksimalnog zida, i odgovarajuće kontaktne podloge (824), funkcionalno povezane s procesorom, gdje je proksimalni zid aksijalno pokretan u odnosu na kućište između prvog proksimalnog položaja, pri čemu nagnuti kontaktni krak i odgovarajuća kontaktna podloga najmanje jednog seta nisu u međusobnom kontaktu, i drugog distalnog položaja, pri čemu nagnuti kontaktni krak i odgovarajuća kontaktna podloga najmanje jednog seta jesu u kontaktnom odnosu kako bi se dozvolilo povećanje snage sklopa elektronike.
10. Modul prema patentnom zahtjevu 9, pri čemu najmanje jedan set nagnutog kontaktnog kraka (822) i odgovarajuće kontaktne podloge (824) sistema prekidača sadrži mnoštvo setova nagnutog kontaktnog kraka i odgovarajuće kontaktne podloge, pri čemu je svaki od setova obodno raspoređen jedan u odnosu na drugi s podjednakim razmakom, pri čemu je jedan od setova u kontaktnom odnosu konfiguriran tako da dozvoli povećanje snage sklopa elektronike.
11. Modul prema patentnom zahtjevu 8, pri čemu kućište dalje sadrži aksijalno kompresibilni element (811) spojen između proksimalnog zida i dijela kućišta da bi pomaknuo proksimalni zid u proksimalni položaj.
12. Modul prema patentnom zahtjevu 1, koji uključuje svjetlovodni prsten (812) i bijelu ili reflektirajuću površinu (860) raspoređenu preko otvora (813) definiranog svjetlovodnim prstenom, svjetlovodni prsten koji uključuje zadržavačke krake (812A) koji vise niz svjetlovodni prsten spojen na dio kućišta, pri čemu sklop elektronike uključuje element (1412) indikatora svjetlosti koji je funkcionalno povezan s procesorom da emitira svjetlost na svjetlovodnom prstenu.
13. Modul prema patentnom zahtjevu 1, pri čemu je bočni zid (404, 472, 482, 504, 604) gumba cilindričan i kućište uključuje mnoštvo radijalno fleksibilnih krakova (420, 520, 850) koji se protežu od distalnog zida, kutno razmaknutih jedan od drugog, pri čemu svaki od krakova ima proksimalno produžen dio (430, 530, 837) ležišta.
14. Modul prema patentnom zahtjevu 1, pri čemu su magnetni senzori (160, 906) konfigurirani tako da budu aksijalno i rotacijski zaključani s bipolarnim magnetnim prstenom (152, 902, 706) tijekom podešavanja doze, i da budu aksijalno i rotacijski slobodni u odnosu na bipolarni magnetni prsten tijekom izdavanja doze, pri čemu su magnetni senzori raspoređeni pod jednakim kutem jedni u odnosu na druge da bi definirali obrazac prstena, pri čemu se kod izdavanja doze magnetni senzori distalno gibaju bliže bipolarnom magnetnom prstenu i magnetni senzori ostaju nepomični u odnosu na rotirajući bipolarni magnetni prsten da bi detektirali rotaciono kretanje bipolarnog magnetnog prstena u cilju generiranja signala položaja.
15. Modul prema patentnom zahtjevu 14, pri čemu magnetni senzori (160, 906) sadrže pet ili šest magnetnih senzora.
16. Modul prema patentnom zahtjevu 14, gdje je svaki od magnetnih senzora (160, 906) jednako radijalno razmaknut, na radijalnom razmaku definiranom od centra magnetnog senzora do osovine modula, pri čemu radijalno rastojanje treba biti jednako rastojanju vanjskog radijusa bipolarnog magnetnog prstena.
17. Modul prema patentnom zahtjevu 14, pri čemu kućište uključuje svjetlovodni element (685, 849) i distalni zid (606, 806) koji definira otvor (684, 836) stupa, svjetlovodni element koji uključuje svjetlovodni stup (853) koji se proksimalno proteže kroz navedeni otvor (836) stupa izvan magnetnih senzora, pri čemu je svjetlovodni element fiksno pričvršćen na distalni zid.
18. Modul prema patentnom zahtjevu 14, pri čemu sklop elektronike dalje sadrži bateriju (621, 861) smještenu proksimalno od magnetnih senzora i funkcionalno povezanu s procesorom.
19. Modul prema patentnom zahtjevu 18, dalje sadrži aksijalno kompresibilni potporni element baterije (864) u kontaktu s proksimalnom stranom baterije.
20. Modul prema patentnom zahtjevu 14, dalje sadrži prekidački sistem (620, 820) konfiguriran tako da poveća snagu sklopa elektronike, pri čemu je proksimalni zid (626, 802) aksijalno pokretan u odnosu na bočni zid (604, 804) modula i na distalni zid (606, 806) da aktivira sistem prekidača.
21. Modul prema patentnom zahtjevu 20, pri čemu prekidački sistem (820) sadrži najmanje jedan set nagnutog kontaktnog kraka (822) i odgovarajuće kontaktne podloge (824), pri čemu se nagnuti kontaktni krak proteže između sklopa elektronike i proksimalnog zida (802) da bi pomaknuo proksimalni zid u proksimalni položaj, kontaktni krak (822) koji uključuje kutni zglob (834) koji hvata proksimalni zid i distalno produženi vrh (835), kontaktna podloga (834) koja je spojena na sklop elektronike i funkcionalno povezana s procesorom, pri čemu je proksimalni zid aksijalno pokretan u odnosu na kućište do distalnog položaja, tako da su navedeni vrh i kontaktna podloga u kontaktnom odnosu kako bi se dozvolilo povećanje snage sklopa elektronike.
22. Modul prema patentnom zahtjevu 14, pri čemu sklop proksimalnog zida uključuje svjetlovodni prsten (812), i sklop elektronike uključuje element indikatora svjetlosti koji je funkcionalno povezan s procesorom da emitira svjetlost na svjetlovodnom prstenu.
23. Modul prema patentnom zahtjevu 22, pri čemu svjetlovodni prsten (812) uključuje zadržavače krakove (812A) za pričvršćivanje koji vise niz distalnu površinu svjetlovodnog prstena spojenog sa djelom kućišta, pri čemu kućište dalje sadrži stlačivu zaptivku (811) spojenu između svjetlovodnog prstena (812) i elementa (815) prvog odstojnika da pomakne sklop (802) proksimalnog zida u proksimalni položaj.
24. Modul prema patentnom zahtjevu 22, pri čemu sklop proksimalnog zida uključuje element koji ima bijelu ili reflektujuću površinu (860) raspoređenu preko otvora (813) definiranog svjetlovodnim prstenom.
25. Modul prema patentnom zahtjevu 1, pri čemu je bočna strana dugmeta cilindrična a kućište uključuje mnoštvo radijalno fleksibilnih krakova (420, 520, 850) koji se protežu od distalnog zida.
26. Modul prema patentnom zahtjevu 14, pri čemu je doprinos grešci biranja od magnetnih senzora i rasporeda bipolarnog magnetnog prstena dva stupnja ili manje, gdje je greška biranja razlika između biranog položaja, koji odgovara fizičkom rotacionom položaju bipolarnog magnetnog prstena, i detektiranog položaja, koji odgovara detektiranom rotacijskom položaju bipolarnog magnetnog prstena koji detektiraju magnetni senzori.
HRP20231380TT 2018-02-22 2019-02-20 Modul sistema za detektiranje doze za uređaj za davanje lijeka HRP20231380T1 (hr)

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US201862633655P 2018-02-22 2018-02-22
US201862779652P 2018-12-14 2018-12-14
EP19709275.2A EP3755404B1 (en) 2018-02-22 2019-02-20 Dose detection system module for medication delivery device
PCT/US2019/018780 WO2019164955A1 (en) 2018-02-22 2019-02-20 Dose detection system module for medication delivery device

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WO2019164936A1 (en) 2018-02-22 2019-08-29 Eli Lilly And Company Medication delivery device with a sensed element
WO2019175615A1 (en) * 2018-03-14 2019-09-19 Biocorp Production S.A. Dose control device for injectable-drug delivery devices
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CA3090525A1 (en) 2019-08-29
JP2020519392A (ja) 2020-07-02
AU2021204040A1 (en) 2021-07-08
AU2019225813B2 (en) 2021-03-18
JP7069330B2 (ja) 2022-05-17
MD3755404T2 (ro) 2023-12-31
SI3755404T1 (sl) 2023-11-30
US20210330888A1 (en) 2021-10-28
IL276758A (en) 2020-10-29
EP3755404A1 (en) 2020-12-30
JP2022065152A (ja) 2022-04-26
AU2022221385A1 (en) 2022-09-15
JP7030930B2 (ja) 2022-03-07

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