DE102023116436A1 - automatic syringe - Google Patents

Abstract

The invention relates to a syringe device with a pressure can and with a valve, wherein the can is provided for receiving an injection agent and a propellant gas for expelling the injection agent from the pressure can, and with an adapter cap with a first connection for connecting the adapter cap to the valve of the can and a second connection for connecting a cannula for injecting the injection agent. The syringe device enables the automated injection of a defined dose of an injection agent.

Description

The invention relates to a syringe device with automated injection agent dispensing for use in human and veterinary medicine.

Medicines intended for injection using a syringe are currently offered as standard in a vial, a glass bottle or an ampoule. The injection agent must first be individually drawn into a syringe from these containers before it can be administered.

There are already filled syringes for only a few special applications, for example for thrombosis prevention or as so-called injection pens for injecting insulin.

The preparation of medication for injection, for example from a vial, which is still necessary in most other cases, has various disadvantages.

On the one hand, this known procedure is material-intensive. For a single injection, you currently need the substance to be injected in a vial, a syringe, possibly separate cannulas for drawing up and injecting, at least three alcohol pads to disinfect the vial and the injection site, possibly a swab to treat bleeding, for example, and a plaster to protect the injection site after the injection.

Above all, however, the preparations for the injection are time-consuming and prone to errors due to the large number of steps that have to be carried out. For example, with a vial, the metal cover or metal closure of the vial must first be removed and then the rubber lid of the vial must be disinfected with an initial alcohol pad.

The puncture site on the patient’s body must then be disinfected with a second alcohol pad.

The cannula must then be placed on a syringe and the protective cap removed from the cannula. The cannula must then be inserted into the rubber cap of the vial and the desired amount of injection agent must be drawn up with as few air bubbles as possible. Attaching the cannula can lead to puncture injuries and manually drawing up the injection agent can lead to incorrect dosing if too much or too little injection agent is drawn up.

If necessary, the drawing cannula must then be replaced with an injection cannula, which again brings with it the risk of puncture wounds and contamination. To do this, the protective cap must be removed from the injection cannula and the syringe held so that the tip of the injection cannula is pointing upwards. In order to keep the injection channel free of air bubbles, the syringe plunger must be pushed forward carefully, which is another source of error if air bubbles remain in the cannula or too much injection agent escapes.

This is followed by the insertion and slow injection, whereby a consistent injection speed is preferred, but this is often not achieved and also depends on the user. Finally, if necessary, any bleeding at the puncture site is treated with a swab, the puncture site is disinfected with a third alcohol pad and the wound is covered with a plaster.

• Durch die bekannte Vorgehensweise wird viel Müll produziert, die korrekte Injektionsdosis ist letztendlich abhängig vom korrekten Aufziehen des Injektionsmittels durch den Arzt, beim Aufsetzen und Wechsel der Kanülen besteht Verletzungs- und Kontaminationsgefahr, die Geschwindigkeit der manuell durchgeführten Injektion ist in der Regel ungleichmäßig und abhängig von der Erfahrung des Arztes.

In summary, the known approach shows the following problems:

• The known procedure produces a lot of waste, the correct injection dose ultimately depends on the doctor correctly drawing up the injection agent, there is a risk of injury and contamination when inserting and changing the cannulas, the speed of the manually performed injection is usually uneven and depends on the doctor's experience.

Last but not least, the known procedure involves many work steps and is associated with a high level of time expenditure and undesirable susceptibility to errors. The procurement logistics, stocking and warehousing of the individual components are also quite complex.

It is therefore an object of the invention to provide an alternative syringe device which does not have the aforementioned disadvantages.

This object is achieved by an invention having the features of claim 1. Advantageous embodiments are the subject of the dependent claims. It should be noted that the features listed individually in the claims can also be combined with one another in any desired and technologically expedient manner and thus show further embodiments of the invention.

A syringe device according to the invention comprises a pressure can, hereinafter also referred to simply as “can”, with a valve, wherein the can is designed to hold an injection agent and a propellant gas for expelling the injection agent from the pressure can. The syringe device according to the invention further comprises an adapter cap, wherein the adapter cap comprises a first connection for connecting the adapter cap to the valve of the can and a second connection for a cannula for injecting the injection agent.

The valve of the can and the adapter cap are preferably connected to each other via a plug connection.

The cannula is connected to the adapter cap via connectors commonly used in medicine, such as a Luer connector.

The cannula of the adapter cap can be designed in the manner of a Strauss cannula, i.e. with a proximally arranged support for the user's fingers in order to open the valve of the can by pressure.

Accordingly, the valve of the can is designed in such a way that the valve opens when pressure is applied to the stem, whereby in this case the pressure is exerted on the valve or the stem by the adapter cap or the connection provided therein.

Alternatively, the cannula can be integrated into the adapter cap and the needle can be retracted into the adapter cap to avoid injuries from the protruding cannula during handling.

In order to ensure that the injection agent and propellant are separated, a can with a BOV system (“Bag on Valve”) is preferred, i.e. a can with a bag valve. The injection agent is in the bag, and the bag is sealed fluid-tight with the inner part of the actual valve.

Inside the can, the propellant gas is located between the can wall and the bag. The two media - injection agent and propellant gas - are thus strictly separated from one another and cannot mix or react with one another.

Another advantage of this preferred embodiment is that the amount of injection agent in the bag and the pressure of the propellant gas can be specifically coordinated with one another, so that an optimal amount of injection agent can be injected under optimal pressure conditions. At the same time, a uniform injection speed is ensured.

In addition to the pressure applied in the can, the connection or the cannula of the adapter cap can also serve as a throttle to further regulate the flow of the injection agent. The use of cannulas of different sizes, i.e. cannulas with different inner diameters, and/or the use of connections with different inner diameters leads to different flow rates or flow volumes. The regulation of the flow rate is also conceivable alternatively or additionally by setting it using a separate mechanism.

The flow rate can thus be adjusted between 0.1 ml/s and 5.0 ml/s, preferably between 0.2 ml/s and 4.0 ml/s and in particular between 0.5 ml/s and 3.0 ml/s.

In principle, it is preferred that a specific dose, for example the entire contents of the bag, is injected by triggering the valve. However, it is also possible for specific doses to be dispensed via the syringe device, which are predetermined, for example, by a dosing device, as will be explained below. Of course, any injection that has begun can also be interrupted by stopping the pressure on the valve.

To prevent the injection of air, the syringe device preferably comprises an air trap provided within the adapter cap between the connection of the adapter cap to the valve of the can and the cannula.

In an alternative embodiment, the can and the bag of the bag valve can also be made transparent in order to be able to visually detect possible contamination or the formation of air bubbles.

To ensure that the injection agent can only flow in one direction, namely from the container into the cannula, a medical check valve, i.e. a non-return valve, can preferably be provided inside the adapter cap. This is preferably provided between the connection of the adapter cap to the valve of the container and the cannula or between the air trap and the cannula.

The syringe device according to the invention is preferably intended for single use. However, embodiments are also conceivable in which several doses of the injection agent are located in one bag. In these cases, the syringe device comprises a dosing chamber, which is preferably provided inside the bag. The dose can then be adjusted by adjusting the volume of the dosing chamber, in which for example by lengthening or shortening the dosing chamber.

Syringe devices for single use may alternatively comprise such a dosing chamber for setting the dose.

Likewise, the syringe devices may comprise an element for adjusting the respective injection dose, for example a metered dose valve.

In order to track the number of doses already administered or still present in a syringe device for multiple use, such a syringe device preferably comprises a display device, in particular a counting device, for example in the form of an analogue or a digital display such as a counting disc.

For medical documentation purposes, both the counting device or adapter cap and the container itself can contain a machine-readable identifier such as a barcode or QR code for unique identification.

The syringe device according to the invention is basically suitable for all types of injections such as intramuscular, intraarterial, intravenous and subcutaneous applications. If necessary, the syringe device can comprise an additional spiral tube as a connector, in particular for intraarterial and intravenous applications, which is arranged, for example, rolled up in the adapter cap.

The syringe device according to the invention is also suitable for use in automated injection devices, such as injectors or syringe pumps, in which the injection is carried out remotely using a computer.

Accordingly, the syringe device according to the invention also includes embodiments in which intended settings such as volume settings of the dosing chamber, duration of the injection, etc. can also be carried out electronically.

Also included are embodiments in which the injection data such as set flow rate, volume dose, time stamp of the injection, etc. can be digitally recorded, stored and electronically transferred.

The syringe device according to the invention has a number of advantages over known systems. For example, the syringe device according to the invention produces significantly less waste, especially if it is intended for multiple use. A uniform injection speed is achieved.

Due to significantly fewer work steps such as the elimination of cannula changes, drawing up the correct dose, etc., the syringe device according to the invention offers a significant time saving and is at the same time less prone to errors. Overall, it can be assumed that there is greater sterility due to a lower potential for contamination, a lower potential for injury from needle sticks, an overall more reliable dosage administration and fewer mix-ups due to machine-readable documentation of both the display device and the can itself.

The invention and the technical environment are explained in more detail below with reference to the figures. It should be noted that the figures show a particularly preferred embodiment of the invention. However, the invention is not limited to the embodiment shown. In particular, the invention includes, as far as it is technically reasonable, any combination of the technical features listed in the claims or described in the description as relevant to the invention.

• 1 eine erste bevorzugte Ausführungsform der Spritzenvorrichtung im Längsschnitt;
• 2 eine zweite bevorzugte Ausführungsform der Spritzenvorrichtung gemäß 1 mit zusätzlicher Dosierkammer im Längsschnitt;
• 3 eine dritte bevorzugte Ausführungsform der Spritzenvorrichtung gemäß 2 mit einer Anzeigevorrichtung im Längsschnitt;
• 4 die dritte bevorzugte Ausführungsform der Spritzenvorrichtung gemäß 3 in einer perspektivischen Draufsicht;
• 5 die Adapterkappe der dritten bevorzugten Ausführungsform der Spritzenvorrichtung gemäß 3 in einer perspektivischen Durchsicht;
• 6 die Adapterkappe der dritten bevorzugten Ausführungsform der Spritzenvorrichtung gemäß 5 in einer perspektivischen Draufsicht.

They show:

• 1 a first preferred embodiment of the syringe device in longitudinal section;
• 2 a second preferred embodiment of the syringe device according to 1 with additional dosing chamber in longitudinal section;
• 3 a third preferred embodiment of the syringe device according to 2 with a display device in longitudinal section;
• 4 the third preferred embodiment of the syringe device according to 3 in a perspective top view;
• 5 the adapter cap of the third preferred embodiment of the syringe device according to 3 in a perspective view;
• 6 the adapter cap of the third preferred embodiment of the syringe device according to 5 in a perspective top view.

1 shows a first preferred embodiment of the syringe device in longitudinal section. The syringe device comprises a can 1, inside which a bag 2 is arranged. The bag 2 can be filled with an injection agent and opens into a valve 3. Between the can 1 and the bag 2 there is a propellant which exerts pressure on the bag 2.

An adapter cap 5 is provided on the valve 3 in a form-fitting manner.

Pressing the adapter cap 5 opens the valve 3 and the injection agent is pressed from the bag 2 through the valve 3 into the cannula 6. An optional air trap 4 prevents the injection of air.

2 shows a longitudinal section through the second preferred embodiment of the syringe device according to 1 with an additional dosing chamber 7, whereby the dosing chamber 7 is provided inside the bag 2 in front of the valve 3. The dosing chamber 7 is provided to hold a specific amount of injection agent and only releases this amount when the valve is pressed. The dose can be set, for example, by extending the dosing chamber 7. A dosing chamber 7 can improve the dosing accuracy accordingly. Alternatively, the desired dose can already be provided in the bag 2 in syringe devices for single use, which is then completely emptied when the valve 3 is pressed. In syringe devices for multiple use, however, a dosing chamber 7 is necessary or at least helpful.

3 shows a longitudinal section through the second preferred embodiment of the syringe device according to 2 with a display device 8, 9 in the form of an analogue counting disc 8 and a viewing window 9 in the adapter cap 5. The display device counts, for example, the number of injections, preferably in syringe devices for multiple use.

4 shows a perspective view of the second preferred embodiment of the syringe device according to 3 with a display device 8, 9 in the form of an analogue counting disc 8 and a viewing window 9 in the adapter cap 5. The display device counts, for example, the number of injections, preferably in syringe devices for multiple use.

5 shows the adapter cap 5 of the third preferred embodiment of the syringe device according to 3 in a perspective view with a display device 8 in the form of an analogue counting disc 8 and a viewing window 9 (not shown). The display device counts, for example, the number of injections, preferably in syringe devices for multiple use.

6 shows a perspective view of the third preferred embodiment of the syringe device according to 5 with a display device 8, 9 in the form of an analogue counting disc 8 and a viewing window 9 in the adapter cap 5. The display device counts, for example, the number of injections, preferably in syringe devices for multiple use.

list of reference symbols

1

can (pressure can)

2

bag (Bag on Valve (BOV) with liquid)

3

valve

4

air trap

5

adapter cap

6

cannula

7

dosing chamber

8

counting disc

9

display window

Claims (11)

Syringe device with a pressure can (1) and with a valve (3), wherein the pressure can (1) is provided for receiving an injection agent and a propellant gas for expelling the injection agent from the pressure can (1), and with an adapter cap (5) with a first connection for connecting the adapter cap (5) to the valve (3) of the pressure can (1) and a second connection for connecting a cannula (6) for injecting the injection agent. syringe device according to claim 1 , characterized in that the pressure can (1) is a can (1) with a BOV system (2) and the injection agent is provided in the bag of the BOV system (2). syringe device according to claim 1 or 2 , characterized in that the syringe device comprises a dosing chamber (7). Syringe device according to one of the preceding claims, characterized in that the cannula (6) is provided in the manner of a Strauss cannula. Syringe device according to one of the preceding claims, characterized in that an air trap (4) is provided within the adapter cap (5) between the connection of the adapter cap (5) to the valve (3) of the can (1) and the cannula (6). Syringe device according to one of the preceding claims, characterized in that a medical check valve is provided within the adapter cap (5). Syringe device according to one of the preceding claims, characterized in that the syringe device comprises a display device (8, 9) for tracking the number of doses already applied or still present. Syringe device according to one of the preceding claims, characterized in that the adapter cap (5) or the can (1) comprise a machine-readable code for unambiguous assignment. Syringe device according to one of the preceding claims, characterized in that the connection between the adapter cap (5) and the cannula (6) is provided via a Luer-Lock connector. Syringe device according to one of the preceding claims, characterized in that the syringe device comprises an element for adjusting the injection dose, in particular a metered dose valve. A syringe device according to any preceding claim for use with an automatic injection device.

Images