Automatic syringe

The syringe device with a BOV system and regulated flow mechanism addresses the inefficiencies and risks of manual injection by ensuring consistent and accurate dosing, reducing waste and contamination, and simplifying the injection process.

WO2024261272A1PCT designated stage expired Publication Date: 2024-12-26EASYJECTOR GMBH
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Patent Information

Application Number
PCT/EP2024/067490
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-06-22
Filing Date
2024-06-21
Publication Date
2024-12-26

AI Technical Summary

Technical Problem

The current method of preparing medications for injection from vials is material-intensive, time-consuming, prone to errors, and involves risks of injury and contamination due to the multiple steps required, including handling multiple components and manual dose administration, which also complicates logistics and storage.

Method used

A syringe device with a pressure can and adapter cap that uses a Bag on Valve (BOV) system to separate injection agent and propellant gas, featuring a Luer connector for the cannula, an air trap to prevent air injection, and a mechanism to regulate flow rate, ensuring consistent and accurate dosing with reduced handling steps.

Benefits of technology

The solution significantly reduces waste, ensures uniform injection speed, minimizes errors and contamination, and simplifies logistics by providing a more reliable and efficient method for medication delivery with fewer steps and improved sterility.

✦ Generated by Eureka AI based on patent content.

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Abstract

The invention relates to a syringe device comprising: a pressurized can and a valve, the can being designed to hold an injectable substance and a propellant gas for expelling the injectable substance from the pressurized can; and an adapter cap having a first connection for connection of the adapter cap to the valve of the can and a second connection for connection of a cannula for injection of the injectable substance. The syringe device allows automated injection of a defined dose of an injectable substance.
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Description

[0001] Automatic sorting

[0002] The invention relates to a syringe device with automated injection agent dispensing for use in human and veterinary medicine.

[0003] Medications intended for injection via a syringe are currently offered as standard in a vial, glass bottle, or ampoule, for example. From these containers, the injection agent must first be individually drawn into a syringe before it can be administered.

[0004] Pre-filled syringes are only available for a few specific applications, for example for thrombosis prevention or as so-called injection pens for injecting insulin.

[0005] The preparation of medication for injection, for example from a vial, which is still necessary in most other cases, has various disadvantages.

[0006] For one thing, this familiar procedure is material-intensive. A single injection currently requires the substance to be injected in a vial, a syringe, possibly separate needles for drawing up and injecting, at least three alcohol pads to disinfect the vial and the injection site, a swab, if necessary, to treat bleeding, 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 multitude of steps involved. For example, with a vial, the metal cover or metal closure must first be removed, and then the rubber cap of the vial must be disinfected with an alcohol pad.

[0007] The puncture site on the patient's body must then be disinfected with a second alcohol pad.

[0008] Next, the draw-off needle must be placed on a syringe and the protective cap removed. The needle must then be inserted into the rubber cap of the vial and the desired amount of injection agent must be drawn out, as free of air bubbles as possible. Attaching the needle can cause puncture injuries, and manually drawing up the injection agent can lead to incorrect dosing if too much or too little injection agent is drawn out.

[0009] If necessary, the filling needle must then be replaced with an injection needle, which again carries the risk of puncture injuries and contamination. To do this, the protective cap must be removed from the injection needle and the syringe held with the tip of the injection needle facing upward. To keep the injection channel free of air bubbles, the syringe plunger must be carefully advanced. This can be a further source of error if air bubbles remain in the needle or if too much injection agent escapes.

[0010] This is followed by the insertion and slow injection. A consistent injection speed is preferred, but this is often not achieved and also depends on the user. Finally, 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 bandage.

[0011] In summary, the current procedure presents the following problems: The current 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, and the speed of the manually performed injection is generally uneven and dependent on the doctor's experience.

[0012] Last but not least, the current approach involves numerous steps, is time-consuming, and prone to errors. The procurement logistics, inventory management, and warehousing of the individual components are also quite complex.

[0013] It is therefore an object of the invention to provide an alternative syringe device which does not have the aforementioned disadvantages.

[0014] 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, thus revealing further embodiments of the invention.

[0015] A syringe device according to the invention comprises a pressurized can, hereinafter also referred to simply as a "can," with a valve. The can is provided for receiving an injection agent and a propellant gas for expelling the injection agent from the pressurized can. The syringe device according to the invention further comprises an adapter cap, the adapter cap comprising 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.

[0016] The valve of the can and the adapter cap are preferably connected via a plug-in connection. The cannula is connected to the adapter cap via connectors commonly used in medicine, such as a Luer connector.

[0017] The cannula of the adapter cap can be designed in the style 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 applying pressure.

[0018] Accordingly, the valve of the can is designed in such a way that the valve opens when pressure is applied to the star, whereby in this case the pressure is exerted on the valve or the star by the adapter cap or the connection provided therein.

[0019] 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.

[0020] To ensure the separation of the injection agent and propellant, a can with a BOV (bag-on-valve) system is preferred. This system contains the injection agent within the bag, which forms a fluid-tight seal with the internal part of the valve.

[0021] Inside the can, the propellant is located between the can wall and the bag. The two media—injectable and propellant—are thus strictly separated and cannot mix or react with each other.

[0022] 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 rate 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. For example, 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 quantities. The regulation of the flow rate is also conceivable alternatively or additionally by adjustment via a separate mechanism.

[0023] 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.

[0024] In principle, it is preferred that a specific dose, for example, the entire contents of the bag, be injected by triggering the valve. However, it is also possible for specific doses to be delivered via the syringe device, which are predetermined, for example, by a dosing device, as explained below. Of course, any injection that has begun can also be interrupted by interrupting the pressure on the valve.

[0025] 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.

[0026] In an alternative embodiment, the can and the bag of the bag valve can also be transparent in order to be able to visually detect possible contamination or the formation of air bubbles.

[0027] To ensure that the injection agent flows only in one direction, namely from the canister to the cannula, a medical check valve, i.e., a non-return valve, can be provided, preferably within the adapter cap. This is preferably located between the adapter cap's connection to the canister valve and the cannula, or between the air trap and the cannula.

[0028] The syringe device according to the invention is preferably intended for single use. However, embodiments are also conceivable in which multiple doses of the injection agent are contained in one bag. In these cases, the syringe device comprises a dosing chamber, which is preferably provided within the bag. The dose can then be adjusted by adjusting the volume of the dosing chamber, for example, by lengthening or shortening the dosing chamber.

[0029] Single-use syringe devices may alternatively also include such a dosing chamber for setting the dose.

[0030] Likewise, the syringe devices may comprise an element for adjusting the respective injection dose, for example a metered dose valve.

[0031] 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.

[0032] 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.

[0033] The syringe device according to the invention is fundamentally suitable for all types of injections, such as intramuscular, intra-arterial, intravenous, and subcutaneous applications. Optionally, the syringe device can comprise an additional spiral tube as a connector, particularly for intra-arterial and intravenous applications, which is arranged, for example, in a coiled configuration in the adapter cap.

[0034] 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 by computer control using electronics.

[0035] 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.

[0036] Also included are embodiments in which the injection data such as set flow rate, volume dose, timestamp of the injection, etc. can be digitally recorded, stored and transferred electronically.

[0037] The syringe device according to the invention offers several advantages over known systems. For example, the syringe device according to the invention produces significantly less waste, especially when intended for multiple use. A consistent injection rate is achieved.

[0038] By significantly reducing the number of work steps required, such as the elimination of needle changes, drawing up the correct dose, etc., the syringe device according to the invention offers significant time savings and is also less prone to errors. Overall, this can be expected to result in, among other things, greater sterility due to a lower potential for contamination, a lower potential for injury from needle sticks, overall more reliable dosage administration, and fewer mix-ups thanks 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 encompasses, as far as technically reasonable, any combination of the technical features listed in the claims or described in the description as relevant to the invention.

[0039] They show:

[0040] Fig. 1 shows a first preferred embodiment of the syringe device in longitudinal section;

[0041] Fig. 2 shows a second preferred embodiment of the syringe device according to Fig. 1 with an additional dosing chamber in longitudinal section;

[0042] Fig. 3 shows a third preferred embodiment of the syringe device according to Fig. 2 with a display device in longitudinal section;

[0043] Fig. 4 the third preferred embodiment of the

[0044] Syringe device according to Fig. 3 in a perspective top view;

[0045] Fig. 5 the adapter cap of the third preferred

[0046] Embodiment of the syringe device according to Fig. 3 in a perspective view;

[0047] Fig. 6 the adapter cap of the third preferred

[0048] Embodiment of the syringe device according to Fig. 5 in a perspective top view. Figure 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. A propellant is provided between the can 1 and the bag 2, which exerts pressure on the bag 2.

[0049] An adapter cap 5 is provided on the valve 3 in a form-fitting manner.

[0050] 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.

[0051] Figure 2 shows a longitudinal section through the second preferred embodiment of the syringe device according to Figure 1 with an additional dosing chamber 7, wherein the dosing chamber 7 is provided within the bag 2 in front of the valve 3. The dosing chamber 7 is intended to hold a specific amount of injection agent and dispenses only this amount when the valve is pressed. The dose can be adjusted, for example, by extending the dosing chamber 7. A dosing chamber 7 can accordingly improve dosing accuracy. Alternatively, in syringe devices for single use, the desired dose can already be provided in the bag 2, 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.

[0052] Figure 3 shows a longitudinal section through the second preferred embodiment of the syringe device according to Figure 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.

[0053] Figure 4 shows a perspective view of the second preferred embodiment of the syringe device according to Figure 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.

[0054] Figure 5 shows the adapter cap 5 of the third preferred embodiment of the syringe device according to Figure 3 in a perspective view with a display device 8 in the form of an analog counter 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. Figure 6 shows a perspective view of the third preferred embodiment of the syringe device according to Figure 5 with a display device 8, 9 in the form of an analog counter 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.

[0055] Reference symbol list

[0056] 1 can (pressurized can)

[0057] 2 bags (Bag on Valve (BOV) with liquid) 3 valve

[0058] 4 air trap

[0059] 5 adapter cap

[0060] 6 cannula

[0061] 7 Dosing chamber 8 Counting disc

[0062] 9 display windows

Claims

Patent claims 1. 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.

2. 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).

3. Syringe device according to claim 1 or 2, characterized in that the syringe device comprises a dosing chamber (7).

4. Syringe device according to one of the preceding claims, characterized in that the cannula (6) is provided in the manner of a Strauss cannula.

5. 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).

6. Syringe device according to one of the preceding claims, characterized in that a medical check valve is provided within the adapter cap (5).

7. Syringe device according to one of the preceding claims, characterized in that the syringe device comprises a display device (8, 9) to track the number of doses already administered or still available.

8. Syringe device according to one of the preceding claims, characterized in that the adapter cap (5) or the can (1) comprises a machine-readable code for unambiguous assignment.

9. 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.

10. Syringe device according to one of the preceding claims, characterized in that the syringe device comprises an element for Adjustment of the injection dose includes, in particular, a metered dose valve.

11. A syringe device according to any one of the preceding claims for use with an automatic injection device.

Citation Information

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