Ergonomic injection support

Abstract

The invention relates to a needle-safe injection device, said device comprising a body (1) for housing a pre-filled syringe (5); an inner part (2) providing a large contact surface, which is insertable into the body (1) at the end distal to the injection site and extends out of the body (1) at the end proximal to the injection site; a cap (3) enabling the removal of the needle shield (10), which is insertable into the inner part (2) at one end and extends out of the inner part (2) at the other end; and a spring (4) located inside the body (1) around the syringe (5).

Description

[0001] ERGONOMIC INJECTION SUPPORT

[0002] TECHNICAL FIELD

[0003] The invention relates to injection devices for easy and safe administration of prefilled syringes. The injection devices of the invention facilitate a patient’s grip of the needle before, during or after injection, prevents needle injuries and provides a comfortable treatment process by preventing the patient from seeing the needle.

[0004] BACKGROUND OF THE INVENTION

[0005] Injection devices are drug administration apparatuses that enable the injection of drugs suitable for injection into patients and is used by healthcare professionals in hospitals, clinics and home environments, which, in certain diseases and conditions, can also be self-administered by patients. Ready-to-use syringes are normally prepared sterile for parenteral products and injected into the target area with a pushing force. The administration of ready-to-use syringes without any support apparatus may cause many undesirable circumstances such as difficulty in needle penetration into the skin, fear of needles, inability to inject into the targeted area, difficulty in grasping the needle and needle stick accidents.

[0006] Various devices have been developed to overcome these negative circumstances. One of these devices are auto-injectors, which are pre-filled, ready-to-use and typically disposable devices. These are usually designed for intramuscular or subcutaneous injection. The aim of auto-injectors is to address the injection challenges faced by patients by rendering the injection process as patientindependent and automated as possible.

[0007] The state of the art in auto-injector systems is based on the system being triggered by a trigger mechanism, automatically penetrating the needle into the tissue and automatically injecting the drug. The part protecting the needle can be activated actively (by user intervention) or passively (automatically).

[0008] WO2022245308A1 describes a system in which the syringe enables the needle penetrate the skin automatically upon contact without the patient seeing, and the drug is injected after the completion of the penetration of the needle into the muscle / skin, and finally the protective sheath is automatically extended and fastened after use, preventing needle injuries that may occur later.

[0009] Patent application no. TR2016 / 19426 describes a system that does not provide automatic needle penetration but allows the patient to have the needle penetrate and then trigger the injection. The needle protection mechanism is provided by an outer ring comprising a spring that engages with the plastic placed inside. The engagement of the outer system with the inner portion reduces the robustness of that portion of the system and causes difficulties in application.

[0010] Application no. WO2022197265A1 also lacks automatic penetration of the needle, and offers no advantage over existing single-step triggering systems. The needle protection mechanism, proposed to be used with a spring-loaded system, does not include a fastening solution after use.

[0011] The auto-injector of US20230105397A1 is one of the known advanced examples of the auto-injection technique and describes a product which, upon opening of the cap and triggering by pressing on the application site, reveals the characteristics of automatic penetration, automatic injection and automatic extension and fastening of a needle shield.

[0012] Existing auto-injectors have the main problems of having too many components, high costs, requiring automated assembly machines to eliminate human error during assembly, and frequent malfunctions in automatic functions during use. In order to solve these problems, there is a search for a system that can be easily combined with a ready-to-use syringe and is free from errors in assembly and automated functions, which can at the same time provide the highest possible level of facilitated injection.

[0013] An analysis of the systems developed for this purpose has revealed that although a needle protection system is described in US5141500, the basic operational mechanism of this system is based on the principle of pushing and locking the needle protective sheath after injection. US5242416 is similarly based on the principle of extending and locking the needle protection system after use. There are many examples of mechanisms where the needle shield is locked by extending the shield to protect the needle after use. EP1946789B1 contains information on a product that has been put into use and is still in use in this regard. The mechanism of this patent is also intended to prevent needle injuries after injection by extending the shield after use. A similar product is described in EP3131608B 1. EP3341056B1 discloses a system for facilitating the grip of the syringe as well as a triggering mechanism to inject a certain portion of the syringe content. Needle protection is realized by the intervention of the user after application. Although the inventions described herein have provided various solutions for needle protection after injection, their contribution to the user-friendliness of ready-to- use syringes is limited. In recent years, efforts to improve these systems have been directed towards a new system, one of the examples of which is described in EP3595754B1 wherein the needle-protecting cap is removed and replaced by the newly developed system which is then sterilized. The system consists of a shield around the needle cap, which is only slightly wider than the cap, that partially facilitates needle injection via a spring mechanism and is fastened after injection. A similar system is also described in EP3106194B1. This so-called ISS integrated safety system requires the system to be enclosed in the syringe then re-sterilized. This limits the effectiveness of the existing systems. It also fails to offer improvements in issues such as syringe grip and syringe stabilization on the skin.

[0014] As a result, there is a need in the state of the art to develop a safe, user-friendly, easy-to-manufacture and ergonomic injection device that can be applied to prefilled syringes, with a low probability of malfunction during use.

[0015] SUMMARY OF THE INVENTION

[0016] The present invention relates to a safe injection device which can be integrated into all types of pre-filled syringes.

[0017] One object of the invention is to prevent needle bending due to the movement of the needle by a patient or healthcare worker during injection. For this purpose, the injection device of the invention comprises a large catch / fastening surface part. Thanks to said large catch area, the practitioner can stabilize the needle more easily and perform the injection.

[0018] Another object of the invention is to provide an injection device in which a prefilled syringe can be integrated without the need for re-sterilization. Since removing the needle protection cap of a syringe and covering it with a new cap causes sterility problems, the device of the invention has been developed as an integrable system for all types of pre-filled syringes including a ready-to-use needle shield.

[0019] Another object of the invention is that the length of the needle to be penetrated into the skin, regardless of the needle length of the pre-filled syringe, is adjustable by the thickness of the body stabilizing part of the device. Thus, an injection device suitable for all syringe types is provided without the need to make any changes in the dimensions of the pre-filled syringes that are currently in production.

[0020] Another advantage of the device of the invention is that it prevents the patient from seeing the needle during injection, thereby reducing the compliance problem due to fear of needles and providing a mechanism to protect the needle.

[0021] Using a small number of components, the invention provides a system both easily manufacturable and mountable as needle protection systems, and as easy to grip and apply as auto-injectors.

[0022] Another significant advantage of the injection system with a low number of components as proposed by the invention is that device malfunctions are prevented thanks to the simplicity of the mechanism. Since the system is not complex, it has also been possible to develop the injection device to be half the size of existing auto-injectors, thereby rendering it easy to carry for patients. DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 : (A) shows an outer view of the injection device in the assembled state; (B) shows a cross-sectional view of the internal structure of the injection device in the assembled state.

[0024] Figure 2: (A) shows a picture of the injection device body (outer cap) the half opened; (B) shows a view of the inner part alone; (C) shows a view of the cap removing the needle shield alone; and (D) shows a view of the body alone.

[0025] Figure 3: shows internal sectional views of the injection device showing the stages during the injection process with the manual needle shield locking system; (A) shows a sectional view of the ready-to-use, assembled state; (B) shows a sectional view of the state where the needle shield is removed with the help of the cap; (C) shows a sectional view of the state where the needle is inserted into the skin by sliding the body on the inner part; (D) shows a sectional view of the state where the drug is injected into the body by pushing the plunger rod; and (E) shows a sectional view of the state where the device is removed from the skin and the inner part covers the needle again.

[0026] Figure 4: shows the drawings of the injection device showing the stages during the injection process with the automatic needle shield locking system. The descriptions A-F of Figure 4 correspond to the description A-F of Figure 3. List of references

[0027] 1 body

[0028] 2 inner part

[0029] 2.1 catch surface

[0030] 2.2 catch surface portion with modifiable thickness

[0031] 3 cap

[0032] 4 spring

[0033] 5 syringe

[0034] 6 plunger rod

[0035] 7 drug control window

[0036] 8 finger flange

[0037] 9 serrated surface

[0038] 10 needle shield

[0039] 11 stopper

[0040] 12 syringe retainer

[0041] 13 movement limiter

[0042] 14 vertical protrusions

[0043] 15 vertical slots

[0044] 16 vertical recesses

[0045] 17 mounting points

[0046] 18 Circular protrusion

[0047] 19 Flexible arm

[0048] 20 Lock housing

[0049] 21 Closed position of window after use DETAILED DESCRIPTION OF THE INVENTION

[0050] The injection device according to the invention comprises a body (1) for housing the pre-filled syringe, an inner part (2) for concealing and protecting the syringe needle, a cap (3) for removing the needle shield (10) and a spring (4) for performing the injection operation.

[0051] Figure 1-A shows a perspective view of an injection device according to the invention in the assembled state. It is illustrating the body (1) housing the syringe, the inner part (2) for concealing the syringe needle and enabling the device to catch on the skin, the cap (3) for removing the needle shield, the plunger rod (6) for injecting the drug into the body, the drug control window (7) for controlling the drug dose or the color of the drug, the finger flange (8) for facilitating the grip on the body, and the serrated surface (9) for preventing the finger from slipping during the grip.

[0052] Among these elements, the drug control window (7), finger flange (8) and serrated surface (9) are optional and included in a preferred embodiment of the invention.

[0053] Figure 1-B shows the internal structure of an injection device according to the invention in the assembled state. On the exterior of the pre-filled syringe (5), a spring (4) is provided to cover a certain length of the syringe. The syringe is passed through the spring (4) before placement and inserted into the inner part (2) through the needle. Inside the body, the inner part (2) extends from the end point of the spring (4) to the outside of the body.

[0054] The outer diameter of the surface (2.1) of the inner part (2) that is placed on the skin is larger and preferably 1.2 to 12 times longer than the outer diameter of the portion of the inner part (2) that enters the body. The outer diameter of the inner part (2) entering the body is preferably between 7-30 mm. More preferably it is 10-20 mm. The outer diameter of the surface (2.1) of the inner part that is placed on the skin is preferably 15-40 mm, and more preferably 18 to 26 mm. The outer diameter of the body is preferably 0.8 to 10 mm times the outer diameter of the inner part. The outer diameter of the body is preferably 10-40 mm, more preferably 15-25 mm.

[0055] The length of the inner part (2) is preferably selected to substantially cover the needle shield (10).

[0056] The cap (3) for removing the needle shield shown in Figure 1-B is designed to be inserted into the inner part (2) and to house the needle shield (10). The stopper (11) placed inside the syringe (5) is a part which prevents the plunger rod (6) from falling into the syringe (5) and prevents the solution from being contaminated by contact with air. The syringe retainer (12), which helps to keep the syringe stationary in the body, is a circular cavity at the end of the body proximal to the plunger rod (6). The movement limiter (13) limits and determines how far the inner part can move upwards.

[0057] Figure 2-A shows the body of the injection device in opened state. The structure of the inner part (2) is shown in Figure 2-B. It illustrates the skin catch surface (2.1), the vertical protrusions (14) that allow it to slide inside the body, and the portion (2.2) that allows to modify the needle length that can penetrate the skin by changing its thickness. Figure 2-C shows the structure of the cap (3) for removing the needle shield. There are vertical slots (15) at the end of the portion of the cap (3) that enters the inner part (2). Thanks to the gaps created by these slots, the cap flexes and attaches to the throat of the needle shield such that the needle shield comes out by removing the cap. Figure 2-D shows the inner portion of the body. Here there are vertical recesses (16) corresponding to the vertical protrusions of the inner part (2). There are also mounting points (17) in the form of small recesses and protrusions for connecting the two parts of the body. The corresponding mounting points are also located on the symmetrical half of the body.

[0058] Figure 3 shows internal cross-sectional views regarding the stages of the injection process performed by the injection device of the invention with the manual needle shield locking system. In Figure 3-A, the device is assembled and ready for use. Figure 3-B shows the needle shield (10) coming out by the pulling of the cap (3) and releasing the needle tip. Figure 3-C shows the insertion of the needle into the skin by sliding the body (1) over the inner part (2) after stabilizing the catch surface (2.1) of the inner part (2) on the skin. Figure 3-D shows the internal structure of the device during the injection of the drug into the patient’s body by pushing the plunger rod (6). In Figure 3-E, when the injection device is removed from the skin after the injection process is completed, the inner part (2) closes again over the needle by releasing the accumulated energy of the spring (4) in the absence of a pushing force. Thus, the injection is completed without the patient ever seeing the needle.

[0059] Figure 4 shows another view of the injection device during the stages of the injection process with the automatic needle shield locking system. In contrast to the protrusions and recesses (14 and 16), protrusion (18) is circular and moves upwards by flexing the flexible arm (19) when the device is pushed upwards. As the inner part (2) moves downwards by the spring force, the arm (19) guides the protrusion (18) into the lock housing (20) and the movement of part (2) is now limited. This locking action also allows the part (2) to rotate and the window moves to the position (21) that no longer displays the drug. In this way, it is visually understood that the drug has been used. The injection device of the invention significantly reduces the likelihood of malfunction during use, especially due to the fact that it contains few components, in other words, since the components can perform more than one task. In complex devices with more components, a component may break, deform or get stuck during use and the device may lose its function. Another advantage of fewer components is the ease it brings to the production process, cost reduction and higher speed of manufacture. Although the device of the invention contains fewer components, it provides a system that prevents needle bending, ensures good catch of the device on the skin over a large surface area, increases patient comfort by concealing the needle, and allows the pre-filled syringe to be mounted on the device very easily without removing the needle shield. Another advantage of the multi-functionality of the components is that the injection device can be manufactured in a very small size. This allows it to be easily carried even in a pocket, thereby increasing patient compliance.

[0060] In a preferred embodiment of the invention, the ready-to-use length of the injection device, including the plunger rod (6), is between 80 and 140 mm.

[0061] The injection device according to the invention comprises a body (outer part) (1) in which the pre-filled syringe (5) can be inserted as a whole, i.e., without removing the needle shield (10), and an inner part (2) partially inside the body (1), having a surface (2.1) which conceals the syringe needle and enables the needle to be placed / stabilized on the skin. Since the needle shield (10) is not removed before the syringe (5) is inserted into the device, there is no need for a re-sterilization process before use. For this purpose, the size of the body (1) and the inner part (2) can be manufactured in accordance with the size of the pre-filled syringe (5) intended to be used with the device.

[0062] The main function of said skin catch surface (2.1) of the device according to the invention is to ensure that the device contacts / catches on the skin over a large area, thus preventing needle bending and unsuccessful injection procedures. Furthermore, by changing the thickness of the portion (2.2) of the inner part (2) which expands to protrude for providing said surface (2.1), regardless of the needle length of the syringe, it is possible to adjust the length of the needle penetrating the skin. In other words, due to the simplicity and functionality of its internal structure, the device of the invention can be designed to be suitable for all types of syringes by simply by adjusting the dimentions of the parts without any need for complex modifications.

[0063] The catch surface (2.1) described above can be made of the material of the body (1), or it can be produced from a material that provides a rough surface to provide better contact and grip to the skin. In one embodiment of the invention, said surface is coated with a material that provides more grip.

[0064] The injection device according to the invention reduces the compliance problem of patients due to fear of needles by keeping the needle concealed before and after injection thanks to the needle concealing and protecting inner part (2). The needle extends out of the device when the syringe (5) is brought into contact with the skin and a slight pushing force is applied towards the skin with the support of the body (1), so that it penetrates into the skin at the distance required by the treatment and the drug, and when the device is lifted from the skin, it re-enters the device and is concealed. Thus, there is no occasion for the patient to see the needle. In the device according to the invention, two different systems can be applied to protect the needle. In the first system, the needle shield (10) can be removed with the help of the cap (3) before the syringe is used, and after use, the same cap (3) is simply put back on and locked again into its original state so that needle accidents can be prevented. In the second system, the locking mechanism is activated after the patient’s first use by guiding toward the inner part (2) which functions as a needle concealer and shield.

[0065] In a preferred embodiment of the invention, the injection device provides a wide drug control window (7).

[0066] The assembly of the device according to the invention is much simpler than that of integrated needle shields and auto-injectors. First, a spring (4) is placed around the top of the pre-filled syringe (the side extending towards the plunger rod (6)) partially covering the outer portion thereof, then said syringe is inserted into the inner part (2). One part of the body (1) produced in two parts is attached as shown in Figure 2- A such that the syringe (5) fits into the syringe retainer (12). Then, the other symmetrical half of the body (1) is attached to lock the mounting points (17). The number and thickness of the mounting points (17) can be increased or expanded as desired. Then, the assembly is completed by installing the cap (3) that removes the needle shield. The clamping system and design of the needle shield removal cap (3) may vary according to the syringe.

[0067] The characteristic of said cap (3) is that it grips the needle shield so that the needle shield can be removed by grasping and removing the cap. So the needle shield is removed in a single move. In the preferred embodiment of the invention, the gripping feature of the cap is provided by vertical slots (15) arranged at the end of the cap portion that enters the inner part (2). Thanks to the gaps created by these slots, the cap flexes and attaches to the needle shield, so that the needle shield is removed by the removal of the cap. The cap is preferably made of plastic. The mode of operation of the invention will now be explained in the examples below, however it should be noted that the field of use is not limited to these drugs.

[0068] Example 1

[0069] Adrenalin Injection

[0070] A 1 ml long standard syringe with a 5 / 8-inch needle enabling intramuscular injection of 0.3 mg adrenaline in 0.3 ml is mounted on the injection support as a finished product as indicated in the assembly step. The needle shield is easily removed via the needle shield removal cap (3), and the injection device brought into the state shown in Figure 3-B is grasped on the serrated surface (9), then the needle fastener and skin catch surface (2.1) of the injection device is placed on the anterolateral part of the thigh. The system is then pushed against the skin to achieve needle penetration (Figure 3-C). Following penetration, the plunger rod (6) is pushed to enable injection. After a waiting period of 5 seconds, the needle is removed from the injection site in a controlled manner by means of the spring (4) and the needle stabilization system (2, 2.1); and the needle shield (10) located inside the needle shield removal cap (3) is discarded by simply re-protecting the needle by putting the cap back on.

[0071] Example 2

[0072] Glatiramer Acetate Injection

[0073] Ready-to-use syringes containing 20 mg / ml Glatiramer acetate contain 1 ml of solution for injection. The solution is contained in a ready-to-use pre-filled syringe. The recommended dose for adults is 20 mg glatiramer acetate containing solution subcutaneously injected once daily.

[0074] The finished product containing the solution filled into a 1 ml long standard syringe with a Vi inch needle similar to the reference product can be easily inserted into the injection device as described above, then, the patient at first easily removes the needle shield (10) via the needle shield removal cap (3), and grasps the injection support brought into the state shown in Figure 4B on the serrated surface (9), and places the surface (2.1) on the injection site. This structure supports easy grip of the injector and application without slipping. The injection site can be the abdomen, arms, buttocks or thighs. The system is then pushed against the skin to achieve needle penetration (Figure 4-C), which provides at least as much penetration support as integrated needle shields. After penetration, the plunger rod (6) is pushed to enable injection. Again, the push step with the plunger rod (6) can be easily applied thanks to the grip support / finger flange (8). After a waiting period of 5 seconds, the needle is removed from the injection site in a controlled manner by means of the spring (4) and needle stabilization system (2, 2.1); and the used drug is discarded by means of the automatically locked needle shield (10). The automatic locking system is shown in Figure 4-E and Figure 4-F.

Claims

CLAIMS1. An injection device comprising a body (1) for housing a pre-filled syringe (5); an inner part (2) providing a large contact surface, which is insertable into said body (1) at the end distal to the injection site and extends out of the body (1) at the end proximal to the injection site; a cap (3) enabling the removal of the needle shield (10), which is insertable into the inner part (2) at one end and extends out of the inner part (2) at the other end; and a spring (4) located inside the body (1) around the syringe (5).

2. The injection device according to claim 1, wherein the inner part (2) is configured to be slidable inside the body (1).

3. An injection device according to claim 2, comprising vertical protrusions (14) at the outer portion of the inner part (2) and corresponding vertical recesses (16) at the inner portion of the body (1) for enabling the inner part (2) to slide inside the body (1).

4. An injection device according to any one of claims 1 to 3, wherein the inner part (2) extends outside the body (1) and is positioned to cover the needle to conceal and protect the syringe needle before injection, sliding into the body (1) during injection leaving the needle exposed to allow the needle to be inserted into the injection site, and is positioned to cover the needle to conceal and protect the needle again after injection.

5. An injection device according to any one of claims 1 to 4, wherein said cap (3) is configured to surround the needle shield (10) from the outside and to attach and remove the needle shield by the pulling force applied to the cap.

6. An injection device according to any one of claims 1 to 5, wherein said cap (3) comprises vertical slots (15) at the end of the portion that enters the inner part (2).

7. An injection device according to any one of claims 1 to 6, wherein the inner part (2) comprises a catch surface (2.1) to catch on the skin at the injection site, having an outer diameter larger than the outer diameter of the portion of the inner part (2) that is inserted in the body (1) for enabling the device to catch on the injection site.

8. An injection device according to any one of claims 1 to 7, wherein the body (1) comprises a drug control window (7) on it.

9. An injection device according to any one of claims 1 to 8, wherein the body (1) comprises a finger flange (8) on it facilitating the gripping of the body during injection.

10. An injection device of any one of claims 1 to 9, wherein the body (1) comprises a serrated surface (9) on it for preventing the finger from slipping during the gripping of the body.

11. An injection device according to any one of claims 1 to 10, wherein the device comprises a plunger rod (6) for injecting the drug inside the pre-filled syringe (5) into the patient’s body.

12. An injection device according to any one of claims 1 to 11, wherein the body (1) comprises a spring (4), which surrounds the portion of the body (1) distal to the injection site of the pre-filled syringe (5) inside the body (1).

13. An injection device according to any one of claims 1 to 12, wherein the body (1) comprises a syringe retainer (12), which helps to keep the syringe (5) stationary in the body (1) at the end distal to the injection site.

14. An automatic needle protecting fastening system for use in injection devices, comprising a locking mechanism having a circular protrusion (18) which is guided into a lock housing (20) by a flexible arm (19).

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