Proximal cap of automatic drug injection device

CA3323529A1Pending Publication Date: 2026-09-21EM TECH CO LTD
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Patent Information

Application Number
CA3323529
Authority / Receiving Office
CA · CA
Patent Type
Applications
Current Assignee / Owner
Priority Date
2024-03-25
Filing Date
2024-06-28
Publication Date
2026-09-21

AI Technical Summary

Technical Problem

Existing automatic drug injection devices face issues with the detachment of syringe protection caps, which can lead to accidents, especially when infants swallow them, and have difficulties in clear assembly and reattachment of caps due to unclear attachment directions.

Method used

A proximal cap design featuring a cylindrical inner partition, extension arm with a hook portion, and a flexible element with a fixing projection, ensuring the syringe protection cap remains attached during removal and reattachment, and providing clear assembly guidance through auditory and tactile feedback.

Benefits of technology

Prevents accidental detachment of syringe protection caps, simplifies assembly and reattachment, and ensures safe handling by preventing infants from swallowing the caps, while offering intuitive assembly cues.

✦ Generated by Eureka AI based on patent content.
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Abstract

An embodiment relates to a proximal cap of an automatic drug injection device. The proximal cap of the embodiment comprises: an outer cap part that surrounds an outer periphery of an activating member and has a distal end that contacts a housing; a cylindrical inner partition spaced apart from the outer cap part and inserted into the activating member; a proximal surface connecting the outer cap part and the inner partition; a cylindrical side wall inserted into the inner partition; and a detachment prevention cap including a head portion seated on the proximal surface, wherein the detachment prevention cap may have a vent hole having a diameter smaller than the maximum diameter of a syringe protective cap.
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Description

Proximal cap of automatic drug injection device

[0001] The embodiment relates to a proximal cap of an automatic drug injection device.

[0002] In cases of chronic diseases requiring continuous management, such as diabetes, or acute attacks requiring immediate response, such as anaphylactic shock in allergy patients, autoinjectors that allow users to inject themselves without visiting a hospital are widely used.

[0003] An auto-injector in the form of a pen needle has been developed and is widely used. It can be carried around and inserted into an injection site that suits the conditions, automatically inserting the needle into the muscle and automatically injecting the injection liquid by a device such as a spring.

[0004] A dangerous drug injection device is disclosed in Korean Patent Publication No. 10-2012-0028294.

[0005] According to the prior art, the injector illustrated in FIG. 1 has an outer housing member (14) configured to allow a user to handle the injector and substantially accommodate most of the components shown. In some embodiments, the outer housing (14) is formed of two mating portions (not shown) that can be configured to be joined to one another by snap or press-fit assembly, or by using adhesives, welding, or the like. The housing (14) has a fluid chamber (22) therein configured to store and dispense one or more liquid drugs, such as one or more hazardous agents. The fluid chamber (22) is typically formed as a prefillable syringe (18) assembled within the housing (14), although other types of fluid chambers or drug(s) may be used, including cartridges of known form that can be prefilled or refilled. Additionally, the fluid chamber (22) may be integrally formed within the housing (14).

[0006] A locking device (80) is disposed at the distal end of the outer housing (14), i.e., the tip end, which is the upper end of the housing, and is removably attached thereto by a plurality of tabs extending through mating openings formed in the outer housing (14) to form a pressurized assembly between the locking device (80) and the outer housing (14). The locking device (80) is configured to prevent or reduce the possibility of unintentional firing of the injection device, for example, during transport or handling of the injector. The locking device (80) is removable by a user of the injector to allow unrestricted use of the injector.

[0007] Additionally, by securing a safety cap (11) to the end of the injector, the needle guard (66) can be covered and prevented from accidental movement during transportation or handling prior to injection. The cap can be secured to the end of the outer housing (14) by press-fitting, screw-fitting, or the like. The cap (11) can have a pair of projections extending inwardly, and the needle guard (66) can be configured with a pair of radially extending flanges configured to be adjacent to the terminal projections of the projections for securing the cap (11) to the injector.

[0008] Twisting the cap (11) relative to the housing (14) may cause the lugs to move out of alignment with the flange, thereby allowing the cap (11) to be removed from the injector, thereby allowing the cap (11) to be distally moved away from the needle guard (66). To prevent accidental removal of the cap (11) from the injector due to inadvertent rotation of the cap (11), in some embodiments, the cap (11) is required to click away from its closed position, for example, before completing the rotation to remove the cap (11). In this way, the cap (11) is coupled to the housing (14) or the needle guard (66) such that a large initial force is required.

[0009] Meanwhile, during the assembly process of the automatic drug injection device, the assembly is performed with a syringe protection cap (25) installed to prevent the worker from being pricked by the injection needle (24) or the injection needle (24) from being damaged or contaminated during the assembly process.

[0010] When the cap (11) is removed from the housing (14), the syringe protection cap (25) is removed together to expose the injection needle (24). To this end, the cap (11) is provided with a structure for holding the syringe protection cap (25).

[0011] In Fig. 2, the cap (11) of the prior art is illustrated in detail. When the cap (11) is removed from the auto injector, a hole (11e) is formed to secure a breathing hole to prevent an infant from swallowing the cap (11) by blocking the airway, thereby causing suffocation. However, the syringe protection cap (25) may detach from the cap (11) through the hole (11e) formed in the cap (11), and an accident may occur in which the infant swallows the syringe protection cap (25). To prevent this, there is a need for the development of a structure capable of keeping the syringe protection cap (25) within the cap (11) when the cap (11) is removed from the housing (14).

[0012] Meanwhile, to prevent exposure of the needle after drug injection, the cap is sometimes reattached to the housing. However, in conventional technology, the direction of attachment of the cap (11) is not clearly visible, and assembly is difficult without a clear understanding of the structure. Therefore, an improved structure is needed.

[0013] The embodiments aim to provide a proximal cap having a structure capable of preventing the detachment of a syringe protection cap in an automatic drug injection device.

[0014] Additionally, embodiments aim to provide a proximal cap of an automatic drug injection device that is easy to assemble, remove, and re-install.

[0015] An embodiment provides a proximal cap of an automatic drug injection device, comprising: a housing, a drug container having a drug storage portion and an injection needle and a syringe protective cap protecting the injection needle; a plunger for pressurizing the drug in the drug container and discharging it through the injection needle; a trigger module for operating the plunger; and an activating member for activating the trigger module, the proximal cap comprising an outer cap portion surrounding the outer periphery of the activating member and having a distal end in contact with the housing; a cylindrical inner partition formed at a gap from the outer cap portion and inserted into the inside of the activating member; a proximal surface connecting the outer cap portion and the inner partition wall; a cylindrical side wall inserted into the inner partition wall; and a head portion seated on the proximal surface, wherein the anti-disconnection cap is characterized in that it has a vent hole having a diameter smaller than the maximum diameter of the syringe protective cap.

[0016] In another aspect of the present invention, a proximal cap of an automatic drug injection device is provided, characterized in that the proximal cap further includes a flexible element extending from an inner partition, a proximal end being a free end and a distal end being fixed to the inner partition, a fixing projection formed to protrude radially outwardly at the proximal end of the flexible element, and the proximal end of the activating member has an annular catching step protruding radially inwardly, such that the proximal cap is fixed by engagement of the catching step and the fixing projection.

[0017] As another aspect of the embodiment, a proximal cap of an automatic drug injection device is provided, characterized in that it further includes a coupling structure that is coupled with a syringe protection cap when assembled to the automatic drug injection device.

[0018] As another aspect of the embodiment, a proximal cap of an automatic drug injection device is provided, characterized in that when the proximal cap is removed, a combined syringe protective cap is removed together.

[0019] As another aspect of the embodiment, a proximal cap of an automatic drug injection device is provided, including an extension arm extending distally from an inner bulkhead, a hook portion protruding radially inwardly at a distal end of the extension arm and coupled to a syringe protection cap.

[0020] As another aspect of the embodiment, a proximal cap of an automatic drug injection device is provided, characterized in that the length of the extension arm is 5 mm or less.

[0021] In another aspect of the present invention, a proximal cap of an automatic drug injection device is provided, characterized in that the proximal surface has a step for receiving a head portion of the anti-separation cap, and the height of the step is greater than or equal to the height of the head portion.

[0022] The proximal cap of the automatic drug injection device according to the embodiment can prevent an accident in which an infant swallows the syringe protection cap by preventing the syringe protection cap, which is removed together with the proximal cap, from coming off from the housing when removed.

[0023] In addition, the proximal cap of the automatic drug injection device according to the embodiment has the advantage that the syringe protection cap can be easily removed when the proximal cap is removed before use, and can be easily reattached after use.

[0024] Figure 1 is a cross-sectional view of an automatic drug injection device according to the prior art;

[0025] Figure 2 is a drawing showing a cap of an automatic drug injection device according to the prior art;

[0026] Figure 3 is an exploded view showing the joint relationship between the proximal cap of the automatic drug injection device according to the first embodiment and the parts to which the proximal cap is coupled.

[0027] Figure 4 is a drawing showing the appearance of the automatic drug injection device according to the first embodiment before the drug container is combined.

[0028] Figure 5 is a perspective view of a disengagement prevention cap provided in a proximal cap of an automatic drug injection device according to the first embodiment;

[0029] Fig. 6 is a side view of the proximal cap of the automatic drug injection device according to the first embodiment;

[0030] Figure 7 is a cross-sectional view showing the appearance of the syringe protection cap and the proximal cap being combined after the drug container is combined in the automatic drug injection device according to the first embodiment.

[0031] Figure 8 is a cross-sectional view showing the proximal cap of the automatic drug injection device according to the first embodiment removed;

[0032] Figure 9 is a cross-sectional perspective view showing the proximal cap of the automatic drug injection device according to the first embodiment removed;

[0033] Figure 10 is a cross-sectional view of the joint of the proximal cap and housing and the drug container of the automatic drug injection device according to the second embodiment;

[0034] Fig. 11 is a cutaway perspective view of the proximal cap of the automatic drug injection device according to the second embodiment;

[0035] Figure 12 is a drawing showing the process of mounting the proximal cap of the automatic drug injection device according to the second embodiment;

[0036] Fig. 13 is a cross-sectional view showing the mounting appearance of the proximal cap of the automatic drug injection device according to the second embodiment;

[0037] Fig. 14 is a cross-sectional view showing the removal of the proximal cap of the automatic drug injection device according to the second embodiment.

[0038] Hereinafter, embodiments will be described in more detail with reference to the drawings. However, the concept of the present invention may be implemented in many different forms and should not be limited to the embodiments disclosed herein. Rather, these embodiments are provided by way of example so that this disclosure will be thorough and complete and sufficiently convey the scope of the concept of the present invention to those skilled in the art.

[0039] As used herein, the term "proximal end" refers to that end of a drug delivery device from which drug release can be provided. Thus, it is that end of the drug delivery device that is pointed toward an injection or release site. This definition also extends to any internal or external component of the drug delivery device, i.e., the proximal end of any component is the end closest to the proximal end of the drug delivery device. The "distal end" is the end opposite the proximal end.

[0040] "Proximal direction" means the direction from the distal end to the proximal end along the central axis of the drug delivery device. "Distal direction" means the direction opposite to "proximal direction."

[0041] FIG. 3 is an exploded view showing the coupling relationship between the proximal cap of the automatic drug injection device according to the first embodiment and the parts to which the proximal cap is coupled, and FIG. 4 is a drawing showing the appearance of the automatic drug injection device according to the first embodiment before coupling the drug container.

[0042] An automatic drug injection device employing a proximal cap according to an embodiment has a drug container (700) having a drug storage unit (710) for storing a drug in a tubular housing (100) forming an exterior and an injection needle (720) capable of injecting the drug stored in the drug storage unit (710) by piercing the skin, and is fixed thereto. If necessary, a drug holder (730) may be installed in the housing (100), and the drug container (700) may be coupled to the drug holder (730). Meanwhile, in the process of assembling the automatic drug injection device, in order to prevent a worker from being pricked by the injection needle (720) or the injection needle (720) from being bent or contaminated due to impact, the drug container (700) is assembled with a syringe protection cap (740) mounted thereon. The syringe protection cap (740) may be formed as a double structure of an inner protection cap (742) and an outer protection cap (744), if necessary. With the proximal cap (800) coupled to the tubular housing (100), the drug container (700) is assembled by pushing it from the distal end toward the proximal end.

[0043] An activation member (200) and a first elastic member (300) that pressurizes the activation member (200) in a proximal direction are installed on the proximal side of the drug container (700) within the tubular housing (100), and a plunger (not shown) that pressurizes the drug and a trigger module (not shown) that deactivates the plunger (not shown) and then activates it by movement of the activation member (200) are installed on the distal side of the drug container (700). The distal end of the tubular housing (100) is closed and the proximal end is open, and the proximal end of the activation member (200) is exposed outside the proximal end of the tubular housing (100) before drug injection.

[0044] At this time, a proximal cap (800) is mounted on the proximal end of the activating member (200) to prevent the activating member (200) from moving distally unintentionally and exposing the injection needle (720).

[0045] The proximal cap (800) surrounds the outer circumference of the activating member (200) and has an outer cap portion (810) whose distal end is in contact with or close to the housing (100), and a cylindrical inner partition (820) formed on the inner side at a distance from the outer cap portion (810) and inserted into the inner side of the activating member (200).

[0046] The outer cap portion (810) and the inner partition wall (820) are integrally formed by the proximal surface (830). The outer periphery of the proximal surface (830) may extend further outward than the outer cap portion (810). The inner periphery of the proximal surface (830) extends only to the inner partition wall (820), and the proximal end of the inner partition wall (820) is open. A release prevention cap (850) is coupled to the inner partition wall (820) and the proximal surface (830) to prevent the syringe protection cap (740) from being removed.

[0047] Fig. 5 is a perspective view of a disengagement prevention cap provided in a proximal cap of an automatic drug injection device according to the first embodiment.

[0048] The anti-separation cap (850) has a head portion (852) that is seated on the proximal surface (830) of the proximal cap (800) and a cylindrical side wall (854) that extends distally from the head portion (852). The cylindrical side wall (854) is inserted into the inner bulkhead (820) and is fitted with the inner bulkhead (820). At this time, in order to increase the bonding force between the anti-separation cap (850) and the inner bulkhead (820), the outer diameter of the cylindrical side wall (854) may be slightly larger than or may be identical to the inner diameter of the inner bulkhead (820) to cause interference. In order to smoothly insert the cylindrical side wall (854) into the inner bulkhead (820), one or more cut portions (854a) may be provided at the distal end of the cylindrical side wall (854).

[0049] Meanwhile, it is preferable that the anti-separation cap (850) be provided with at least one ventilation hole (852a) in the head portion (852) to prevent the airway from being blocked if the infant swallows the proximal cap (800) entirely. At this time, it is preferable that the diameter of the ventilation hole (852a) be formed smaller than the diameter of the maximum diameter of the syringe cap (740), thereby preventing the syringe cap (740) from being detached through the ventilation hole (852a).

[0050] Figure 6 is a side view of the proximal cap of the automatic drug injection device according to the first embodiment.

[0051] The proximal cap (800) has an extension arm (840) extending distally from the inner bulkhead (820), and a hook portion (842) protruding inwardly at the distal end of the extension arm (840).

[0052] The hook portion (842) engages with the distal end of the syringe protection cap (740) so that the syringe protection cap (740) is removed together with the proximal cap (800) when the proximal cap (800) is removed from the automatic drug injection device.

[0053] The hook portion (842) allows the syringe protection cap (740) to be inserted into the inner partition (820) from the distal end of the extension arm (840), but prevents the syringe protection cap (740) from being detached from the inner partition (820) to the outside through the extension arm (840).

[0054] At this time, the length (L) of the extension arm (840) can be minimized to about 5 mm to prevent the extension arm (840) from easily bending or deforming radially outward. Accordingly, it is possible to prevent the syringe protection cap (740) housed within the inner bulkhead (820) from being removed by an infant deforming the extension arm (840).

[0055] Fig. 7 is a cross-sectional view showing the appearance of the syringe protection cap and the proximal cap being combined after the drug container is combined in the automatic drug injection device according to the first embodiment.

[0056] When the proximal cap (800) is coupled to the tubular housing (100), the drug container (700) is assembled by pushing it from the distal end toward the proximal end, the syringe protection cap (740) is inserted into the inner partition (820) from the distal end of the extension arm (840), and the hook portion (842) is caught on the distal end of the syringe protection cap (740).

[0057] FIG. 8 is a cross-sectional view showing the proximal cap of the automatic drug injection device according to the first embodiment removed, and FIG. 9 is a cross-sectional perspective view showing the proximal cap of the automatic drug injection device according to the first embodiment removed.

[0058] When the proximal cap (800) is pulled in the proximal direction to remove the proximal cap (800) from the activation member (200), the syringe protection cap (740) is removed together due to interference between the syringe protection cap (740) and the hook portion (842).

[0059] As described above, the hook portion (842) allows the syringe protection cap (740) to be inserted into the inner partition (820) from the distal end of the extension arm (840), but prevents the syringe protection cap (740) from being detached from the inner partition (820) to the outside through the extension arm (840). In addition, a detachment prevention cap (850) is mounted proximal to the proximal cap (800) to prevent the syringe protection cap (740) from being detached from the proximal cap (800).

[0060] In particular, referring to FIG. 9, it is preferable that the proximal surface (830) of the proximal cap (800) has a step portion (832) that accommodates the head portion (852) of the anti-separation cap (850). At this time, it is preferable that the height of the step portion (832) is greater than or equal to the height of the head portion (852), so that the head portion (852) cannot be easily removed from the step portion (832) after the head portion (852) is fully inserted into the step portion (832).

[0061] Fig. 10 is a cross-sectional view of the proximal cap and housing of an automatic drug injection device according to a second embodiment, coupled with a drug container. The automatic drug injection device according to the second embodiment is similar to the first embodiment, but differs in that it includes the proximal cap (800a) of the second embodiment.

[0062] In an embodiment, a drug container (700) having a drug storage unit (710) for storing a drug within a tubular housing (100) forming an exterior and an injection needle (720) capable of injecting the drug stored in the drug storage unit (710) by penetrating the skin is secured by a drug holder (730). In addition, during the assembly process of the automatic drug injection device, the assembly is performed with a syringe protection cap (740) mounted to prevent a worker from being pricked by the injection needle (720) or the injection needle (720) from being bent or contaminated due to impact.

[0063] An activation member (200) and a first elastic member (300) that pressurizes the activation member (200) in the proximal direction are installed on the proximal side of the drug container (700) within the tubular housing (100), and a plunger (not shown) that pressurizes the drug and a trigger module (not shown) that deactivates the plunger (not shown) and then activates it by the movement of the activation member (200) are installed on the distal side of the drug container (700). The distal end of the tubular housing (100) is closed and the proximal end is open, and the proximal end (210) of the activation member (200) is exposed outside the proximal end of the tubular housing (100) before drug injection. In addition, a proximal cap (800a) of the second embodiment is mounted on the proximal end (210) of the activation member (200).

[0064] Fig. 11 is a cutaway perspective view of a proximal cap (800a) of an automatic drug injection device according to a second embodiment, and Fig. 12 is a drawing illustrating a process of mounting a proximal cap (800a) of an automatic drug injection device according to a second embodiment. In the second embodiment, the proximal cap (800a) may include an outer cap portion (810), an inner partition (820), and a proximal surface (830), similar to the proximal cap (800) of the first embodiment.

[0065] Meanwhile, the proximal cap (800a) of the second embodiment may additionally be formed to extend from the inner partition (820), and may include a flexible element (860) whose proximal end is free and whose distal end is fixed to the inner partition. At this time, a fixing projection (862) that protrudes outward is formed at the proximal end of the flexible element (860). At this time, the activating member (200) is provided with an annular catch (212) that protrudes radially inward at the proximal end (210), so that the activating member (200) and the proximal cap (800a) are fixed so that they do not separate unless a considerable external force is applied when combined with the activating member (200). In addition, when the proximal cap (800a) is reassembled after the use of the automatic drug injection device is completed, the fixing projection (862) and the catch (212) are reassembled, and auditory feedback and tactile feedback can be generated, so that the user can intuitively recognize that the proximal cap (800a) has been correctly reassembled, which is convenient.

[0066] Fig. 13 is a cross-sectional view showing the mounting appearance of the proximal cap of the automatic drug injection device according to the second embodiment.

[0067] Similar to the automatic drug injection device of the first embodiment, the drug container (700) further includes a syringe protection cap (740) coupled to the injection needle (720). The syringe protection cap (740) may be formed as a double structure of an inner protection cap (742) and an outer protection cap (744) as needed.

[0068] Referring to FIGS. 11 and 13, the proximal cap (800a) has an extension arm (840) extending distally from the inner partition (820), and a hook portion (842) protruding inwardly at the distal end of the extension arm (840). The hook portion (842) engages with the distal end of the syringe protection cap (740), so that when the proximal cap (800a) is removed from the automatic drug injection device, the syringe protection cap (740) is removed together with the proximal cap (800a).

[0069] Fig. 14 is a cross-sectional view showing the removal of the proximal cap of the automatic drug injection device according to the second embodiment.

[0070] When the proximal cap (800a) is pulled proximally to remove the proximal cap (800a) from the activating member (200), the syringe protection cap (740) is removed together with the hook portion (842) due to the engagement of the syringe protection cap (740). The proximal cap (800a) of the automatic drug injection device according to the second embodiment has the advantage that the syringe protection cap (740) can be easily removed together when the proximal cap (800a) is removed before use, and can be easily reattached after use. In addition, since the coupling structure of the activating member (200) and the proximal cap (800a) or the coupling structure of the proximal cap (800a) and the syringe protection cap (740) has no directionality, there is the advantage that assembly, removal, and re-installation are easy.

[0071] As described above, the present invention is not limited to the specific preferred embodiments described above, and anyone having ordinary skill in the art to which the invention pertains can make various modifications without departing from the gist of the present invention claimed in the claims, and such modifications are within the scope of the claims.

Claims

1. A proximal cap of an automatic drug injection device including a housing, a drug container having a drug storage unit and an injection needle and a syringe protection cap protecting the injection needle, a plunger for pressurizing the drug in the drug container and discharging it through the injection needle, a trigger module for operating the plunger, and an activation member for activating the trigger module. An outer cap portion that surrounds the outer periphery of the activation member and whose distal end is in contact with the housing; A cylindrical inner baffle formed at a gap from the outer cap portion and inserted into the inner side of the activating member; The proximal surface connecting the outer cap portion and the inner septum; A detachment prevention cap having a cylindrical side wall inserted into the inner bulkhead and a head portion seated on the proximal surface; A proximal cap of an automatic drug injection device, characterized in that the anti-separation cap has a vent hole having a diameter smaller than the maximum diameter of the syringe protective cap.

2. In paragraph 1, The guard cap is, A flexible element formed by extending from the inner bulkhead, the proximal end being free and the distal end being fixed to the inner bulkhead; It further includes a fixed projection formed to protrude radially outward at the proximal end of the flexible element; A proximal cap of an automatic drug injection device, characterized in that the proximal end of the activation member has an annular catch protrusion protruding radially inward, and the proximal cap is fixed by the engagement of the catch protrusion and the fixing projection.

3. In either paragraph 1 or paragraph 2, A proximal cap of an automatic drug injection device, characterized in that the proximal cap further includes a joining structure that is joined to a syringe protection cap when assembled to the automatic drug injection device.

4. In paragraph 3, A proximal cap of an automatic drug injection device, characterized in that when the proximal cap is removed, the combined syringe protective cap is removed together.

5. In paragraph 3, An extension arm extending distally from the inner bulkhead; A proximal cap of an automatic drug injection device, comprising a hook portion formed to protrude radially inwardly at the distal end of an extension arm and coupled to a syringe protection cap.

6. In paragraph 5, A proximal cap of an automatic drug injection device, characterized in that the length of the extension arm is 5 mm or less.

7. In either paragraph 1 or paragraph 2, A proximal cap of an automatic drug injection device, characterized in that the proximal surface has a step for accommodating the head portion of the anti-separation cap, and the height of the step is greater than or equal to the height of the head portion.