WO2022188907A1 - Procédé et système permettant de réaliser des vaccinations au moyen d'un vaccin - Google Patents

Procédé et système permettant de réaliser des vaccinations au moyen d'un vaccin Download PDF

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Publication number
WO2022188907A1
WO2022188907A1 PCT/DE2022/000022 DE2022000022W WO2022188907A1 WO 2022188907 A1 WO2022188907 A1 WO 2022188907A1 DE 2022000022 W DE2022000022 W DE 2022000022W WO 2022188907 A1 WO2022188907 A1 WO 2022188907A1
Authority
WO
WIPO (PCT)
Prior art keywords
vaccine
syringe
auto
injector
container
Prior art date
Application number
PCT/DE2022/000022
Other languages
German (de)
English (en)
Inventor
Anneliese Hassenbürger
Original Assignee
Hassenbuerger Anneliese
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 Hassenbuerger Anneliese filed Critical Hassenbuerger Anneliese
Priority to DE112022001406.7T priority Critical patent/DE112022001406A5/de
Publication of WO2022188907A1 publication Critical patent/WO2022188907A1/fr

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
    • A61M5/178—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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • 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
    • 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
    • A61M2205/3576—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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/60—General characteristics of the apparatus with identification means
    • A61M2205/6009—General characteristics of the apparatus with identification means for matching patient with his treatment, e.g. to improve transfusion security
    • 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
    • A61M2205/6018—General characteristics of the apparatus with identification means providing set-up signals for the apparatus configuration
    • 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
    • A61M2205/6054—Magnetic identification systems

Definitions

  • the invention relates to a method and a system for carrying out vaccinations with a vaccine or vaccine against a pathogen.
  • a vaccine also referred to as a vaccine, is a biologically or genetically engineered antigen that typically consists of protein components and genetic sections or inactivated or weakened pathogens of the virus to be combated.
  • part of the viral genetic material in the form of DNA or RNA or mRNA is used, which is introduced into the cells and produces certain surface proteins of the virus there, against which the body builds up immune protection, which then also protects against the virus itself works.
  • vials are typically injection or piercing vials made of borosilicate glass. This also applies to vaccines against Covid-19. These vials are produced according to high quality standards, as contamination of the glass and surfaces must be excluded to ensure patient safety. Among other things, modern image processing technologies are used for this purpose. Vials have the advantage that the vaccines can be transported safely and, in particular, the necessary cooling of the vaccine can be carried out easily and safely. Typically, vials have a filling volume of 0.5 ml to 5 ml.
  • each dose of the vaccine has to be drawn up into a syringe for an intramuscular or subcutaneous injection in a patient.
  • this requires particular skill on the part of the respective user, such as a nurse or a vaccinator, since on the one hand the dose to be administered must be drawn up precisely onto the syringe in order to avoid overdosing or underdosing. Overdosing can cause serious side effects, and underdosing has little or no effect.
  • some vaccines such as the BioNTech vaccine with the trade name Comirnaty, a saline solution has to be added.
  • the object of the present invention is therefore to create options for carrying out vaccinations with a vaccine or vaccine against a pathogen that have a higher degree of automation and can be carried out more safely and conveniently.
  • the invention provides a method for carrying out vaccination with a vaccine or a vaccine against a pathogen, using an auto-injector which has a pre-filled syringe with a liquid containing the vaccine or a container with a liquid containing the vaccine includes.
  • the auto-injector has an outer housing with a proximal end and a distal end, which encloses a receiving space in which the syringe is stored with an injection needle and a plunger or in which the container and an injection needle device with an injection needle and a plunger device is mounted, the injection needle of the syringe being protected by a locking device before the auto-injector is used, and a mechanically and/or electrically operated drive device being provided for activating the injection, and the drive device being activated by a triggering mechanism.
  • the syringe and / or the container is equipped with a writable and readable electronic label or chip
  • the electronic label or chip has a communication interface to electronic components of the auto-injector
  • the auto-injector via electronic Components such as sensors and communication interfaces are available for recording data and for forwarding the data via a mobile network to a data processing device such as a server, a processor and/or a cloud computing infrastructure.
  • the electronic components of the syringe and/or the container and/or the auto-injector measure the temperature of the liquid containing the vaccine and/or register the time of the injection.
  • the vaccine or vaccine is an active ingredient against the corona virus or against Covid-19.
  • the invention provides a system for performing vaccination with a vaccine against a pathogen.
  • the system includes an auto-injector and a data processing device such as a server, a processor and/or a cloud computing infrastructure.
  • the autoinjector has an outer housing with a proximal end and a distal end, which encloses a receiving space in which the syringe is stored with an injection needle and a plunger or in which a container and an injection needle device with an injection needle and a plunger device are stored.
  • the syringe and/or the container of the auto-injector is equipped with an electronic label or chip that can be written and read, the electronic label or chip having a communication interface to electronic components of the auto-injector.
  • the auto-injector has electronic components such as sensors and communication interfaces for recording data and for forwarding the data via a mobile network to the data processing device such as the server, the processor and/or the cloud computing infrastructure for data analysis of the label or chip and/or the electronic components of the syringe and/or the container and/or the auto-injector.
  • the data processing device such as the server, the processor and/or the cloud computing infrastructure for data analysis of the label or chip and/or the electronic components of the syringe and/or the container and/or the auto-injector.
  • the injection needle of the syringe is protected by a closure device before the auto-injector is used, the closure device containing a needle protection device for the injection needle on the inside.
  • a mechanically and/or electrically operated drive device is provided for activating the injection in order to press down the plunger, the drive device being activated by a triggering mechanism.
  • a further development provides that the electronic components of the syringe and/or the container and/or the auto-injector measure the temperature of the liquid containing the vaccine and/or register the time of the injection.
  • Algorithms of artificial intelligence are advantageously used for the data analysis of the data recorded with the label and/or the electronic components of the syringe and/or the container and/or the autoinjector.
  • the vaccine or vaccine is an active ingredient against the corona virus or against Covid-19.
  • the invention provides the use of an auto-injector for carrying out a vaccination with a vaccine or vaccine against a pathogen, the auto-injector having an outer housing with a proximal end and a distal end, which encloses a receiving space in which the Syringe is stored with a hypodermic needle and a plunger or in which a container and a hypodermic needle device with a hypodermic needle and a plunger device are stored, with the injection needle of the syringe being protected by a locking device before the use of the autoinjector, and with a mechanical to activate the injection and/or electrically operated drive device is provided, and the drive device is activated by a triggering mechanism.
  • the syringe and/or the container is equipped with a writable and readable electronic label or chip, the electronic label or chip having a communication interface to electronic components of the auto-injector, and the auto-injector having electronic components such as sensors and communication interfaces for recording data and for forwarding the data via a mobile network to a data processing device such as a server, a processor and/or a cloud computing infrastructure.
  • a data processing device such as a server, a processor and/or a cloud computing infrastructure.
  • the vaccine or vaccine is an active ingredient against the corona virus or against Covid-19.
  • FIG. 1 shows a schematic representation of an autoinjector
  • Figure 2 is a schematic representation of a system for performing a
  • an auto injector 10 is shown schematically. It has an outer housing 12 with a proximal end 14 and a distal end 16, which encloses a receiving space in which a syringe 20 with an injection needle 22 and a plunger, not shown here, is mounted.
  • the injection needle 22 of the syringe 20 is closed by a locking device 18 protected like a cap. This can be attached to the outer housing, for example, by means of a screw cap.
  • the closure device 18 contains a needle protection device for the injection needle 22 on the inside, so that it is not damaged during transport.
  • the syringe 20 is a syringe 20 pre-filled with a vaccine.
  • a drive device which is arranged in particular in the distal end 16 of the autoinjector and depresses the plunger.
  • the drive device can be operated mechanically or electrically.
  • the drive device is in turn activated by a trigger mechanism 30, which can also be operated mechanically, for example by means of a spring, or electrically.
  • safety mechanisms can be provided in order to avoid accidental triggering of the drive device.
  • the closure device 18 is removed from the autoinjector 10 and the proximal end 14 is placed over the body site where the injection is to take place. In the case of a vaccination, this is in particular the upper arm. Then the trigger mechanism 30 is actuated and the contained vaccine is injected intramuscularly or subcutaneously. In the case of an autoinjector 10, this is automatically determined by setting the length of penetration of the injection needle 22 into the body tissue. In order to give the user feedback as to whether the injection was successfully carried out, mechanically or electronically designed feedback devices can be provided, for example via optical, acoustic or tactile signals.
  • the syringe 22 can be a commercially available plastic syringe.
  • modular systems consisting of a separate container filled with the vaccine, a plunger and the injection needle, which only form a syringe when inserted into the autoinjector 10, can also be used.
  • the container can, for example, for connection to the hypodermic needle have a front puncture membrane comparable to that of a vial and a sliding stopper for pressing down the injection liquid.
  • a modular syringe system is particularly useful for vaccines against Covid-19, which have to be cooled to low temperatures and are sensitive during transport. This is especially true for genetic vaccines such as BioNTech and Pfizer's Comirnaty® (Tozinameran, BNT162b2) coronavirus vaccine or Moderna Biotech's coronavirus vaccine, which contain sensitive mRNA molecules.
  • the containers with the vaccine can be transported separately from the auto-injectors and are only inserted into the auto-injector 10 shortly before the planned injection, for example in a pharmacy. This ensures safe transport.
  • a data processing system 100 with an autoinjector 10 is shown schematically in FIG. 2 .
  • the auto-injector 10 or the container or the syringe 20 is advantageously equipped with an electronic label 120 or chip which documents, for example, the time at which the container was inserted into the auto-injector 10 .
  • This can involve, for example, NFC or RFID technologies or Bluetooth.
  • the electronic label 120 or the chip can have a communication interface 140 which is connected to electronic components 150 of the autoinjector 10 .
  • These electronic components 150 of the autoinjector 10 can in turn contain sensors and other communication interfaces, in particular to a mobile network. For example, the sensors can register the time of the injection and/or measure the temperature.
  • a data processing device such as a server 200, a processor 300 and/or a cloud computing infrastructure 400 or another network by means of the communication interfaces.
  • the electronic label 120 of the container or the syringe 20 and/or the electronic components 150 of the autoinjector 10 can be personalized with the data of the respective patient, so that a patient and an injection can be clearly assigned. It makes sense to measure the temperature, since the vaccines should usually only be exposed to room temperature (up to 30 °C) for as short a time as possible.
  • autoinjectors 10 equipped in particular with electronic components 150 can be designed as reusable autoinjectors 10 since only the syringe 20 or the container with the vaccine and the injection needle device have to be replaced after use. The remaining components can be designed in such a way that they can be easily and safely disinfected for further use.
  • the electronic label 120 of the container or of the prefilled syringe 20 can contain security features in order to rule out drug counterfeiting.
  • very precise traceability is possible in this way, for example with regard to the production site of the vaccine.
  • simulation auto-injectors are constructed in a similar way to the real devices, but without an injection needle. The user can thus remove the cap, place the proximal end of the auto-injector on the skin and actuate the trigger mechanism to get a feel for how the skin contact and the trigger mechanism feels. This can be repeated any number of times until the user is ready to inject with the real auto-injector. As a result, a user's fears can be reduced and the safe handling of the auto-injector can also be trained.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Primary Health Care (AREA)
  • Medical Informatics (AREA)
  • Immunology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un procédé de réalisation d'une vaccination avec un vaccin ou un agent de vaccination contre un agent pathogène, qui utilise un auto-injecteur (10) comprenant une seringue pré-remplie (20) contenant un liquide renfermant le vaccin, ou un récipient contenant un liquide renfermant le vaccin.
PCT/DE2022/000022 2021-03-08 2022-03-03 Procédé et système permettant de réaliser des vaccinations au moyen d'un vaccin WO2022188907A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
DE112022001406.7T DE112022001406A5 (de) 2021-03-08 2022-03-03 Verfahren und system zur durchführung von impfungen mit einem vakzin

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102021001210.0A DE102021001210A1 (de) 2021-03-08 2021-03-08 Verfahren zur Durchführung von Impfungen mit einem Vakzin
DE102021001210.0 2021-03-08

Publications (1)

Publication Number Publication Date
WO2022188907A1 true WO2022188907A1 (fr) 2022-09-15

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ID=81750772

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/DE2022/000022 WO2022188907A1 (fr) 2021-03-08 2022-03-03 Procédé et système permettant de réaliser des vaccinations au moyen d'un vaccin

Country Status (2)

Country Link
DE (2) DE102021001210A1 (fr)
WO (1) WO2022188907A1 (fr)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014011740A1 (fr) * 2012-07-10 2014-01-16 Becton Dickinson France S.A.S. Système d'injection intégré et dispositif de communication
WO2018195270A1 (fr) * 2017-04-19 2018-10-25 Medimmune, Llc Auto-injecteurs e-connectés
EP3734605A1 (fr) * 2019-04-30 2020-11-04 Ypsomed AG Transmission sécurisée de données d'administration de médicaments

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014011740A1 (fr) * 2012-07-10 2014-01-16 Becton Dickinson France S.A.S. Système d'injection intégré et dispositif de communication
WO2018195270A1 (fr) * 2017-04-19 2018-10-25 Medimmune, Llc Auto-injecteurs e-connectés
EP3734605A1 (fr) * 2019-04-30 2020-11-04 Ypsomed AG Transmission sécurisée de données d'administration de médicaments

Also Published As

Publication number Publication date
DE102021001210A1 (de) 2022-09-08
DE112022001406A5 (de) 2024-01-11

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