WO2022188907A1

WO2022188907A1 - Method and system for performing vaccinations with a vaccine

Info

Publication number: WO2022188907A1
Application number: PCT/DE2022/000022
Authority: WO
Inventors: Anneliese Hassenbürger
Original assignee: Hassenbuerger Anneliese
Priority date: 2021-03-08
Filing date: 2022-03-03
Publication date: 2022-09-15
Also published as: DE102021001210A1; DE112022001406A5

Abstract

The invention relates to a method for performing a vaccination with a vaccine or inoculation against a pathogen, in which method an autoinjector (10) is used which has: a pre-filled syringe (20) comprising a liquid containing the vaccine; or a container comprising a liquid containing the vaccine.

Description

Method and system for performing vaccinations with a vaccine

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. In genetic vaccines, 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.

At present, such vaccines are usually in liquid form and are generally filled in vials. These 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.

However, there are typically several doses of the drug in a vial, so that each dose of the vaccine has to be drawn up into a syringe for an intramuscular or subcutaneous injection in a patient. However, 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. In addition, with some vaccines, such as the BioNTech vaccine with the trade name Comirnaty, a saline solution has to be added. In the case of Comirnaty, this is typically 1.8 ml of a 0.9% solution for a dose of 0.3 ml of vaccine. On the one hand, this is expensive and, on the other hand, it cannot always be ensured that the correct amount of saline solution is actually mixed into the vaccine.

In addition, it must be ensured that there is no air in the injection syringe, which in turn requires the additional attention of the user, i.e. usually the doctor.

It is therefore not surprising that vaccinating a large population group, such as vaccination against the corona virus, involves a great deal of organizational effort, but also time. Diluting and drawing up the active substance takes a lot of time if this is to be carried out with due care by competent persons. However, this leads to vaccination delays, since despite sufficient vaccines being available, the number of vaccinations carried out cannot be increased due to the limited number of doctors in the vaccination centers for organizational and technical reasons. However, this is unacceptable in a pandemic like Corona and puts government officials under considerable pressure to explain.

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.

This object is achieved according to the invention with regard to a method by the features of patent claim 1, with regard to a system by the features of claim 6, and with regard to a use of an auto-injector by the features of patent claim 13. The further claims relate to preferred embodiments of the invention. According to a first aspect, 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.

A further development provides that 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.

In an advantageous embodiment it is provided that 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, and 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.

In a further embodiment it is provided 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. In particular, the vaccine or vaccine is an active ingredient against the corona virus or against Covid-19.

According to a second aspect, 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. In addition, 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.

In a further development, 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.

In a further embodiment it is provided that for holding the syringe or the container fixed or movably arranged holding elements are arranged on the inside of the outer housing. In particular, 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.

In particular, the vaccine or vaccine is an active ingredient against the corona virus or against Covid-19.

According to a third aspect, 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. A further development provides that 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.

The invention is explained in more detail below using an exemplary embodiment illustrated in the drawing.

It shows:

FIG. 1 shows a schematic representation of an autoinjector;

Figure 2 is a schematic representation of a system for performing a

Vaccination with a vaccine.

Additional features, aspects, and advantages of the invention or embodiments thereof will become apparent from the detailed description coupled with the claims.

In Fig. 1, 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. Before using the auto-injector 10, 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. In particular, 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. To hold the syringe 20 , stationary or movably arranged holding elements are arranged in particular on the inside of the outer housing 12 . To activate the syringe 20 for an injection, a drive device, not shown in detail here, is provided, 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. In particular, safety mechanisms can be provided in order to avoid accidental triggering of the drive device.

For an injection, 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. However, 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.

The use of 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. These data are passed on to 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. In addition, 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. In addition, 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.

In addition, the electronic label 120 of the container or of the prefilled syringe 20 can contain security features in order to rule out drug counterfeiting. In addition, very precise traceability is possible in this way, for example with regard to the production site of the vaccine.

Since the vaccine is only injected once or twice and the majority of users (patients) have no experience in handling auto-injectors 10, it makes sense to use simulation auto-injectors. These 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.

By using auto-injectors 10 for vaccination with a vaccine against a virus, in particular against the corona virus, it is possible for a patient who would like to be vaccinated to carry out this vaccination himself. As a result, it is no longer necessary for a vaccinator to carry out the vaccination, which means that there is a considerable potential for saving the doctors' time, which they can use for other activities. In addition, the vaccination can be carried out more quickly because the vaccine does not have to be drawn up into a syringe. In addition, the vaccination process could be more comfortable for many patients because they Feeling that you have control over triggering the vaccination in your own hands. Since many patients are afraid of injections, this could also increase the willingness to vaccinate. Furthermore, when electronic labels 120 are used with a prefilled syringe 20 or with a filled container, the data acquisition and thus the tracking, in particular of the effects and side effects of the vaccination in a patient, can be improved. The use of communication interfaces to mobile terminals with processors 300, servers 200 and cloud computing infrastructures 400 enables the prerequisites for connectivity and data acquisition. In a further development, artificial intelligence algorithms such as reinforcement learning using agents and a reward system or neural networks such as convolutional neural networks in particular can be used to process the data in order to better link the patient data and thus provide better indications of the effects and side effects of the drug to receive vaccine. In particular, new knowledge about the infection process with a virus such as Corona can be gained in this way.

Reference sign

10 auto injector

12 outer casing

14 proximal end

16 distal end

18 locking device

20 syringe

22 hypodermic needle

30 trigger mechanism

100 systems

120 electronic label/chip

140 communication interface

150 electronic components

200 servers

300 processor

400 cloud computing infrastructure

Claims

patent claims

1. Method for carrying out a vaccination with a vaccine or a vaccine against a pathogen, using an auto-injector (10) which comprises a pre-filled syringe (20) with a liquid containing the vaccine or a container with a liquid containing the vaccine .

2. The method of claim 1, wherein the auto-injector (10) has an outer housing (12) with a proximal end (14) and a distal end (16) which encloses a receiving space in which the syringe (20) with an injection needle ( 22) and a plunger or in which the container and an injection needle device with an injection needle (22) and a plunger device are mounted, with the injection needle (22) of the syringe (20) being closed by a locking device ( 18) is protected, and wherein a mechanically and/or electrically operated drive device is provided for activating the injection, and the drive device is activated by a triggering mechanism (30).

3. The method according to claim 1 or 2, wherein the syringe (20) and/or the container is equipped with an electronic label (120) or chip that can be written and read, the electronic label (120) or the chip being connected via a communication interface (140 ) to electronic components (150) of the auto-injector (10), and wherein the auto-injector (10) has electronic components (150) 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 (200), a processor (300) and/or a cloud computing infrastructure (400).

4. The method according to claim 3, wherein the electronic components (150) of the syringe (20) and/or the container and/or the autoinjector (10) measure the temperature of the liquid containing the vaccine and/or register the time of the injection becomes.

5. The method according to any one of claims 1 to 4, wherein the vaccine or vaccine is an active ingredient against the corona virus or against Covid-19.

6. System (100) for carrying out a vaccination with a vaccine or vaccine against a pathogen, comprising an auto-injector (10) and a data processing device such as a server (200), a processor (300) and/or a cloud computing infrastructure (400), wherein the autoinjector (10) has an outer housing (12) with a proximal end (14) and a distal end (16) which encloses a receiving space in which the syringe (20) with an injection needle (22) and a piston or in which a container and an injection needle device with an injection needle (22) and a piston device are stored, the syringe (20) and/or the container of the autoinjector being equipped with an electronic label (120) or chip that can be written and read is, wherein the electronic label (120) or the chip has a communication interface (140) to electronic components (150) of the auto-injector (10), and wherein the auto-injector (1 0) has electronic components (150) 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 (200), the processor (300) and/or the cloud computing infrastructure (400 ) for a data analysis of the data recorded with the label (120) or chip and/or the electronic components (150) of the syringe (20) and/or the container and/or the autoinjector (10).

7. System (100) according to claim 6, wherein before the use of the autoinjector (10), the injection needle (22) of the syringe (20) is protected by a closure device (18), the closure device (18) having a needle protection device for the injection needle on the inside (22) contains.

8. System (100) according to claim 6 or 7, wherein to hold the syringe (20) or the container on the inside of the outer housing (12) fixed or movably arranged mounting elements are arranged.

9. System (100) according to any one of claims 6 to 8, wherein a mechanically and/or electrically operated drive device is provided for activating the injection in order to depress the plunger, and wherein the drive device is activated by a trigger mechanism (30).

10. System (100) according to any one of claims 6 to 9, wherein the temperature of the liquid containing the vaccine is measured by the electronic components (150) of the syringe (20) and/or the container and/or the autoinjector (10), and/or the time of injection is registered.

11. System (100) according to one of claims 6 to 10, wherein for the data analysis with the label (120) and/or the electronic components (150) of the syringe (20) and/or the container and/or the autoinjector ( 10) collected data algorithms of artificial intelligence are used.

12. System (100) according to any one of claims 6 to 11, wherein the vaccine or vaccine is an active ingredient against the corona virus or against Covid-19.

13. Use of an auto-injector for carrying out a vaccination with a vaccine or vaccine against a pathogen, wherein the auto-injector (10) has an outer housing (12) with a proximal end (14) and a distal end (16) having a receiving space encloses, in which the syringe (20) is stored with an injection needle (22) and a plunger or in which a container and an injection needle device with an injection needle (22) and a plunger device are stored, the injection needle being removed before use of the autoinjector (10). (22) of the syringe (20) is protected by a closure device (18), and a mechanically and/or electrically operated drive device is provided for activating the injection, and the drive device is activated by a triggering mechanism (30).

14. Use of an autoinjector according to claim 13, wherein the syringe (20) and/or the container is equipped with an electronic label (120) or chip that can be written and read, the electronic label (120) or the chip being communicated via a communication interface (140) to electronic components (150) of the auto-injector (10), and wherein the auto-injector (10) has electronic components (150) 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 ( 200), a processor (300) and/or a cloud computing infrastructure (400).

15. Use of an auto-injector according to claim 13 or 14, wherein the vaccine or vaccine is an active ingredient against the corona virus or against Covid-19.