CO2022013811A2 - Sistema de infusión de radiofármacos - Google Patents

Sistema de infusión de radiofármacos

Info

Publication number
CO2022013811A2
CO2022013811A2 CONC2022/0013811A CO2022013811A CO2022013811A2 CO 2022013811 A2 CO2022013811 A2 CO 2022013811A2 CO 2022013811 A CO2022013811 A CO 2022013811A CO 2022013811 A2 CO2022013811 A2 CO 2022013811A2
Authority
CO
Colombia
Prior art keywords
quality control
infusion system
radiopharmaceutical
controller
control steps
Prior art date
Application number
CONC2022/0013811A
Other languages
English (en)
Inventor
Indranil Nandi
Original Assignee
Jubilant Pharma Holdings Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Jubilant Pharma Holdings Inc filed Critical Jubilant Pharma Holdings Inc
Publication of CO2022013811A2 publication Critical patent/CO2022013811A2/es

Links

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
    • A61M5/007—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 for contrast 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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • 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
    • A61M5/1407—Infusion of two or more substances
    • A61M5/1409—Infusion of two or more substances in series, e.g. first substance passing through container holding second substance, e.g. reconstitution systems
    • 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
    • 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
    • A61M5/16877—Adjusting flow; Devices for setting a flow rate
    • A61M5/16881—Regulating valves
    • 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
    • A61M5/172—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 electrical or electronic
    • 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
    • A61M5/31571—Means preventing accidental administration
    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06F—ELECTRIC DIGITAL DATA PROCESSING
    • G06F21/00—Security arrangements for protecting computers, components thereof, programs or data against unauthorised activity
    • G06F21/50—Monitoring users, programs or devices to maintain the integrity of platforms, e.g. of processors, firmware or operating systems
    • G06F21/55—Detecting local intrusion or implementing counter-measures
    • G06F21/56—Computer malware detection or handling, e.g. anti-virus arrangements
    • G06F21/566—Dynamic detection, i.e. detection performed at run-time, e.g. emulation, suspicious activities
    • 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
    • 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
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/40—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
    • 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
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/67—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04L—TRANSMISSION OF DIGITAL INFORMATION, e.g. TELEGRAPHIC COMMUNICATION
    • H04L63/00—Network architectures or network communication protocols for network security
    • H04L63/14—Network architectures or network communication protocols for network security for detecting or protecting against malicious traffic
    • H04L63/1441—Countermeasures against malicious traffic
    • H04L63/145—Countermeasures against malicious traffic the attack involving the propagation of malware through the network, e.g. viruses, trojans or worms
    • 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
    • A61M2005/1401—Functional features
    • A61M2005/1403—Flushing or purging
    • 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
    • A61M2205/27—General characteristics of the apparatus preventing use
    • A61M2205/276—General characteristics of the apparatus preventing use preventing unwanted 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
    • A61M2205/50—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
    • A61M2205/581—Means for facilitating use, e.g. by people with impaired vision by audible feedback
    • 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
    • A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
    • 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
    • G—PHYSICS
    • G21—NUCLEAR PHYSICS; NUCLEAR ENGINEERING
    • G21G—CONVERSION OF CHEMICAL ELEMENTS; RADIOACTIVE SOURCES
    • G21G1/00—Arrangements for converting chemical elements by electromagnetic radiation, corpuscular radiation or particle bombardment, e.g. producing radioactive isotopes
    • G21G1/0005—Isotope delivery systems

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Public Health (AREA)
  • Computer Security & Cryptography (AREA)
  • Anesthesiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Hematology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Vascular Medicine (AREA)
  • Primary Health Care (AREA)
  • Epidemiology (AREA)
  • Medical Informatics (AREA)
  • General Business, Economics & Management (AREA)
  • Business, Economics & Management (AREA)
  • Computer Hardware Design (AREA)
  • General Engineering & Computer Science (AREA)
  • Virology (AREA)
  • Theoretical Computer Science (AREA)
  • Physics & Mathematics (AREA)
  • Software Systems (AREA)
  • Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Chemistry (AREA)
  • Signal Processing (AREA)
  • Computer Networks & Wireless Communication (AREA)
  • General Physics & Mathematics (AREA)
  • Computing Systems (AREA)
  • Fluid Mechanics (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Abstract

Se proporcionan aquí las características de seguridad para el sistema de infusión de radiofármacos para su uso con propósitos de tratamiento o diagnóstico, donde el sistema de infusión comprende un controlador, una fuente de radiofármaco incluyendo otros componentes. El controlador está configurado ¬para realizar pasos automatizados de control de calidad al inicio del sistema durante el control de calidad diario y asegurar que el sistema cumple con los atributos técnicos deseados antes de la administración a los pacientes. Los pasos de control de calidad comprenden la calibración, las pruebas de paso del isótopo parental a la elusión (breakthrough), la comprobación de la conexión no autorizada y/o el malware en el sistema, la red u otros dispositivos conectados.
CONC2022/0013811A 2020-02-28 2022-09-27 Sistema de infusión de radiofármacos CO2022013811A2 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202062983498P 2020-02-28 2020-02-28
PCT/US2021/020086 WO2021174122A1 (en) 2020-02-28 2021-02-26 Radiopharmaceutical infusion system

Publications (1)

Publication Number Publication Date
CO2022013811A2 true CO2022013811A2 (es) 2022-10-31

Family

ID=77490528

Family Applications (1)

Application Number Title Priority Date Filing Date
CONC2022/0013811A CO2022013811A2 (es) 2020-02-28 2022-09-27 Sistema de infusión de radiofármacos

Country Status (7)

Country Link
US (1) US20230093338A1 (es)
EP (1) EP4111340A4 (es)
AU (1) AU2021228228A1 (es)
BR (1) BR112022017186A2 (es)
CA (1) CA3169525A1 (es)
CO (1) CO2022013811A2 (es)
WO (1) WO2021174122A1 (es)

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US11775816B2 (en) 2019-08-12 2023-10-03 Micron Technology, Inc. Storage and access of neural network outputs in automotive predictive maintenance
US11635893B2 (en) 2019-08-12 2023-04-25 Micron Technology, Inc. Communications between processors and storage devices in automotive predictive maintenance implemented via artificial neural networks
US11748626B2 (en) 2019-08-12 2023-09-05 Micron Technology, Inc. Storage devices with neural network accelerators for automotive predictive maintenance
US12061971B2 (en) 2019-08-12 2024-08-13 Micron Technology, Inc. Predictive maintenance of automotive engines
US11586943B2 (en) 2019-08-12 2023-02-21 Micron Technology, Inc. Storage and access of neural network inputs in automotive predictive maintenance
US11853863B2 (en) 2019-08-12 2023-12-26 Micron Technology, Inc. Predictive maintenance of automotive tires
US11586194B2 (en) 2019-08-12 2023-02-21 Micron Technology, Inc. Storage and access of neural network models of automotive predictive maintenance
US11498388B2 (en) 2019-08-21 2022-11-15 Micron Technology, Inc. Intelligent climate control in vehicles
US20210053574A1 (en) * 2019-08-21 2021-02-25 Micron Technology, Inc. Monitoring controller area network bus for vehicle control
US11702086B2 (en) 2019-08-21 2023-07-18 Micron Technology, Inc. Intelligent recording of errant vehicle behaviors
US11693562B2 (en) 2019-09-05 2023-07-04 Micron Technology, Inc. Bandwidth optimization for different types of operations scheduled in a data storage device
US11650746B2 (en) 2019-09-05 2023-05-16 Micron Technology, Inc. Intelligent write-amplification reduction for data storage devices configured on autonomous vehicles
US11250648B2 (en) 2019-12-18 2022-02-15 Micron Technology, Inc. Predictive maintenance of automotive transmission
US11531339B2 (en) 2020-02-14 2022-12-20 Micron Technology, Inc. Monitoring of drive by wire sensors in vehicles
US11709625B2 (en) 2020-02-14 2023-07-25 Micron Technology, Inc. Optimization of power usage of data storage devices

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US4160910A (en) * 1977-06-20 1979-07-10 Union Carbide Corporation Rechargeable 99MO/99MTC generator system
US6931552B2 (en) * 2001-05-02 2005-08-16 James B. Pritchard Apparatus and method for protecting a computer system against computer viruses and unauthorized access
US20050108557A1 (en) * 2003-10-11 2005-05-19 Kayo David G. Systems and methods for detecting and preventing unauthorized access to networked devices
US20060004737A1 (en) * 2004-07-02 2006-01-05 Grzonka Michael T Computer virus protection for automated pharmaceutical processes
CN104784770B (zh) * 2008-06-11 2019-06-11 布拉科诊断公司 包括计算机辅助维护和/或操作的输注系统
US8607340B2 (en) * 2009-07-21 2013-12-10 Sophos Limited Host intrusion prevention system using software and user behavior analysis
US8707427B2 (en) * 2010-04-06 2014-04-22 Triumfant, Inc. Automated malware detection and remediation
EP3696824B1 (en) * 2012-09-05 2023-07-19 Jubilant Draximage, Inc. Rubidium elution system control
CN106104303B (zh) * 2014-03-13 2019-06-14 布拉科诊断公司 实时核同位素检测
AU2018250978A1 (en) * 2017-04-14 2019-10-31 Jubilant Draximage Inc. Rubidium elution system

Also Published As

Publication number Publication date
AU2021228228A1 (en) 2022-09-29
US20230093338A1 (en) 2023-03-23
EP4111340A1 (en) 2023-01-04
BR112022017186A2 (pt) 2022-11-08
WO2021174122A1 (en) 2021-09-02
CA3169525A1 (en) 2021-09-02
EP4111340A4 (en) 2024-03-27

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