KR102676491B1 - Auto-injector - Google Patents

Abstract

The purpose of the embodiment is to provide an automatic drug injection device that simplifies the structure, reduces the number of parts, is easy to assemble, and allows locking and feedback.
Examples include a tubular housing forming an exterior appearance; An activation member slidably installed within the tubular housing; a first elastic member pressing the proximal end of the activating member in a proximal direction; A tubular extension member installed at the distal end of the tubular housing; A plunger slidably installed within the tubular extension member; a second elastic member pressing the plunger in the proximal direction; and a drug container equipped with an injection needle capable of injecting the drug stored in the drug storage section by infiltrating the storage section and the skin, into which the proximal end of the plunger is inserted and fixed to the tubular housing. The tubular extension member includes a It has one or more locking holes, the plunger protrudes outward from the tubular extension member through the locking hole, and has one or more locking pieces elastically movable in the radial direction, and the proximal end of the activating member is exposed to the outside of the tubular housing for a predetermined length. When the proximal end slides in the distal direction of the tubular housing due to an external force, the distal end of the activation member pushes the locking piece of the plunger into the locking hole of the tubular extension member and generates a drug starting sound at the same time as the locking is released, and the second elastic member Provides an automatic drug injection device characterized in that the injection of the drug is started by pressurizing the plunger.

Description

Automatic drug injection device {AUTO-INJECTOR}

The embodiment relates to an automatic drug injection device.

In the case of chronic diseases that require continuous management, such as diabetes, or acute attacks that require immediate response, such as anaphylactic shock in allergy patients, self-injectors that allow users to inject fluids on their own without visiting a hospital are widely used.

A pen needle-type auto injector, which can be carried around and inserted into an injection location that meets the conditions, automatically inserts the needle into the muscle, and allows the injection solution to be automatically injected by a device such as a spring, has been developed and is widely used.

However, in the case of conventional auto-injectors, there was a problem in that it was impossible to tell whether drug injection had started or whether drug injection was completed. Additionally, there was a disadvantage in that the needle of the auto-injector was exposed to the outside when pulled out from the user's body after drug injection was completed.

To solve this problem, a number of auto injectors have been developed that have a structure that locks the injection needle after injection of the injection solution is completed or a feedback structure that can inform the injection status of the injection solution.

Republic of Korea Patent No. 10-2059765 discloses a drug injection device equipped with an automatic feedback mechanism.

Referring to Figure 1, the drug delivery device 1 according to the prior art includes a plunger rod 11 and a plunger 13 disposed to be biased toward the proximal end 3a, and biasing the plunger rod 11 in the proximal direction. a first elastic member, that is, an energy accumulation member 15, which is arranged to bias the drug delivery member cover 7 in the proximal direction, and a second elastic member or energy accumulation member ( 9) and a tubular rotor 17 arranged to receive the plunger rod 11 and the first energy accumulating member 15, and a tubular extension member axially and rotationally fixed relative to the housing 3 5) and a tubular actuating member 17, hereinafter referred to as a tubular rotor 17, arranged to receive a portion of the rear end cap 7 and the plunger rod 11, and a first energy accumulating member 15. It further comprises a rod 19 arranged to receive and a signal generating member 21, hereinafter illustrated as a U-shaped bracket, hereinafter referred to as a “U-bracket”. The illustrated drug delivery device 1 further includes a drug container 25 provided with a drug container holder 23 and a needle 25a. The plunger 13 is arranged to travel within the drug container 25 by linear displacement of the plunger rod 11 and release the drug through the needle 25a.

The plunger rod (11), the tubular extension member (5), the tubular actuating member (17), the energy accumulating member (15) and the signal generating member (21) are an automatic feedback mechanism (12) for the drug delivery device (1) or simply Form a feedback mechanism. The feedback mechanism 12 is arranged to inform the user of the beginning of release of drug from the drug container 25.

Before use, the plunger rod is placed axially fixed in an initial position. When the drug delivery device is activated, that is, when the user initiates drug delivery, the plunger rod is released from its initial position and is pressed in the proximal direction by the energy accumulation member. When the plunger rod is displaced by a distance corresponding to the distance required for initiation of drug release, the contact between the first section of the plunger rod and the signal generating member will cease. Accordingly, the plunger rod and the signal generating member are designed so that the axial overlap of the first section and the signal generating member in the initial position of the plunger rod is equal to or substantially equal to the distance. Accordingly, the first section only supports the signal generating element during the axial displacement of the plunger rod distance corresponding to the distance required for initiation of drug release. If the plunger rod is displaced by an amount corresponding to this distance, the signaling member will bend radially inward without being biased in that radial direction. By this, the signal generating member will be separated from the tubular extension member. Accordingly, the signal generating member biased in the distal direction by the first energy accumulating member will no longer be held by the tubular extension member and will therefore be thrown towards the distal inner surface of the tubular extension member. This creates an audible “click” sound and also provides a tactile sensation to the user.

However, in the case of a conventional automatic drug injection device, an operating member for releasing the lock and operating the plunger rod, a member for locking the drug container holder after drug injection is completed, and a member for generating feedback are separately provided. By doing so, the number of parts increased and assembly was complicated.

Therefore, there is a need to develop an automatic drug injection device that simplifies the structure, reduces the number of parts, is easy to assemble, and allows locking and feedback.

US Patent Publication US20050273054A1 Republic of Korea Patent No. 10-2059765

The purpose of the embodiment is to provide an automatic drug injection device that simplifies the structure, reduces the number of parts, is easy to assemble, and allows locking and feedback.

Examples include a tubular housing forming an exterior appearance; An activation member slidably installed within the tubular housing; a first elastic member pressing the proximal end of the activating member in a proximal direction; A tubular extension member installed at the distal end of the tubular housing; A plunger slidably installed within the tubular extension member; a second elastic member pressing the plunger in the proximal direction; and a drug container equipped with an injection needle capable of injecting the drug stored in the drug storage section by infiltrating the storage section and the skin, into which the proximal end of the plunger is inserted and fixed to the tubular housing. The tubular extension member includes a It has one or more locking holes, the plunger protrudes outward from the tubular extension member through the locking hole, and has one or more locking pieces elastically movable in the radial direction, and the proximal end of the activating member is exposed to the outside of the tubular housing for a predetermined length. When the proximal end slides in the distal direction of the tubular housing due to an external force, the distal end of the activation member pushes the locking piece of the plunger into the locking hole of the tubular extension member and generates a drug starting sound at the same time as the locking is released, and the second elastic member Provides an automatic drug injection device characterized in that the injection of the drug is started by pressurizing the plunger.

As another aspect of the embodiment, when the plunger is slid to a predetermined position in the proximal direction by the second elastic member, the locking piece of the plunger comes out in the proximal direction of the proximal end of the tubular extension member, and the locking piece leaves the tubular extension member. An automatic drug injection device is provided, characterized in that it generates a drug termination sound.

As another aspect of the embodiment, the activation member has a locking hole for receiving the locking piece of the plunger that leaves the tubular extension member when the external force is removed and the activation member slides in the proximal direction by the first elastic member and returns to the original position, and is activated. An automatic drug injection device is provided, wherein the locking piece of the plunger is inserted into the locking hole of the member to lock the activating member and generate a final locking sound.

As another aspect of the embodiment, the plunger has a body and an L-shaped arm extending from the outer peripheral surface of the body, and the locking piece extends radially from the distal end of the L-shaped arm. An automatic drug injection device is provided. do.

In another aspect of the embodiment, the plunger locked with the activation member prevents movement of the activation member by contacting the proximal end of the tubular extension member with the L-shaped arm of the plunger even when a pressing force is applied to the distal side by the activation member. An automatic drug injection device is provided.

In another aspect of the embodiment, the proximal end of the tubular extension member has an inclined surface extending further proximally on the inner side to guide the L-shaped arm of the plunger to move radially outward when the L-shaped arm of the plunger moves distally. An automatic drug injection device is provided.

In another aspect of the embodiment, an automatic drug injection device is provided wherein the L-shaped arm of the plunger has a distal end having an inclined surface corresponding to an inclined surface formed at the proximal end of the tubular extension member.

In another aspect of the embodiment, an automatic drug injection device is provided, wherein the plunger has a tubular body, and the second elastic member has a proximal end received within the tubular body.

As another aspect of the embodiment, a second elastic member guide is inserted into the distal end of the second elastic member to guide compression and expansion of the second elastic member, and the distal end is fixed to the tubular extension member; further comprising: An automatic drug injection device is provided.

In another aspect of the embodiment, an automatic drug injection device is provided, wherein the proximal end of the second elastic member guide is received within the tubular body.

As another aspect of the embodiment, an automatic drug injection device is provided, further comprising a container holder fixed to the tubular housing and into which the drug container is installed.

As another aspect of the embodiment, an automatic drug injection device is provided, wherein the container holder and the tubular housing each have a window through which the amount of drug stored in the drug container can be confirmed.

The drug injection device provided by the embodiment has the advantage of reducing the number of parts, simplifying the structure, and providing visual, tactile, and auditory feedback by allowing the plunger to function as both a locking mechanism and feedback generation.

1 is a diagram showing a drug injection device equipped with an automatic feedback mechanism according to the prior art;
Figure 2 is an exploded view showing an automatic drug injection device according to an embodiment;
Figure 3 is a perspective view showing an automatic drug injection device according to an embodiment;
Figure 4 is a perspective view showing a tubular housing of an automatic drug injection device according to an embodiment;
Figure 5 is a perspective view showing an activation member of an automatic drug injection device according to an embodiment;
Figure 6 is a perspective view showing the plunger of an automatic drug injection device according to an embodiment;
Figure 7 is a perspective view showing a tubular extension member of an automatic drug injection device according to an embodiment;
Figure 8 is a cross-sectional view showing the automatic drug injection device before drug injection according to an example;
Figure 9 is a cross-sectional view showing the start of drug injection of an automatic drug injection device according to an embodiment;
Figure 10 is a cross-sectional view showing the end of drug injection of the automatic drug injection device according to an embodiment;
Figure 11 is a cross-sectional view showing the final locking of the activation member of the automatic drug injection device according to an embodiment.

Hereinafter, the embodiment will be described in more detail with reference to the drawings. However, the concept of the present invention may be embodied in many different forms and should not be limited to the embodiments disclosed herein, but rather, these embodiments are intended to ensure that the present disclosure is thorough and complete and does not convey the scope of the inventive concept to those skilled in the art. It is provided as an example so that it can be sufficiently conveyed.

As used herein, the term “proximal end” refers to that end of a drug delivery device at which drug release can be provided. Therefore, it is that end of the drug delivery device that is pointed towards the 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 to the proximal end.

“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”.

Figure 2 is an exploded view showing an automatic drug injection device according to an embodiment, and Figure 3 is a perspective view showing an automatic drug injection device according to an embodiment.

The automatic drug injection device according to the embodiment includes a tubular housing 100 forming an exterior, an activation member 200 installed to slide in the axial direction on the proximal end side of the tubular housing 100, and an activation member. It includes a first elastic member 300 that presses 200 in the proximal direction. The proximal end 210 of the activation member 200 is exposed outside the proximal end 110 of the tubular housing 100 (see FIG. 4) before drug injection.

Additionally, a tubular extension member 500 is installed at the distal end 120 (see FIG. 4) of the tubular housing 100. The tubular extension member 500 closes the distal end 120 of the tubular housing 100 and has a tube structure therein. A plunger 400 is slidably installed within the tubular extension member 500.

A second elastic member 610 is installed between the tubular extension member 500 and the plunger 400, and the second elastic member 610 is installed in a compressed state so as to press the plunger 400 in the proximal direction. . If necessary, a second elastic member guide 620 that can guide compression and expansion of the second elastic member 610 may be installed. The distal end of the second elastic member guide 620 is fixed to the tubular extension member 500.

A drug container 710 is installed in the tubular housing 100, which includes a drug storage unit 712 for storing the drug and an injection needle 714 for injecting the stored drug. The drug container 710 maintains its position fixed in the tubular housing 100 by the drug holder 720 regardless of the movement of the activation member 200 or the plunger 400.

At this time, the proximal end of the plunger 400 is assembled in a state inserted at a predetermined depth within the drug storage portion 712, so that when the second elastic member 610 presses the plunger 400, the plunger is inserted into the drug storage portion 714. As 400 moves in the proximal direction, the drug is injected into the user's body through injection needle 714.

Figure 4 is a perspective view showing a tubular housing of an automatic drug injection device according to an embodiment.

As described above, the tubular housing 100 has a proximal end 110 and a distal end 120, and the previously described components are fixedly or movably installed in the internal space. As described above, the drug container 710 is fixed to the tubular housing 100 by the container holder 720 (see FIG. 2). The container holder 720 and the tubular housing 100 store the drug in the drug container 710. It is preferable that the window 130 is formed so that the amount of drug stored in the unit 712 can be visually confirmed.

Figure 5 is a perspective view showing an activation member of an automatic drug injection device according to an embodiment.

The activation member 200 has a proximal end 210 in a tubular shape and has a contact surface 212 at the distal end of the proximal end 210 that contacts the user's skin. A hole 214 is provided in the center of the contact surface 212, and when the activation member 200 retracts, the injection needle 714 is exposed through the hole 214.

The activating member 200 further includes a trigger portion 220 extending distally from the proximal end 210 . The trigger unit 220 is a part for releasing the initial locking of the locking piece 430 (see FIG. 6) of the plunger 400, which will be described later, and activating the plunger 400. Meanwhile, at a predetermined distance from the distal end of the trigger portion 220, there is a locking hole 222 for final locking of the plunger 400 and the activation member 200 after the plunger 400 has finished moving in the proximal direction. is formed

Figure 6 is a perspective view showing the plunger of an automatic drug injection device according to an embodiment.

The plunger 400 is a part that moves to the proximal end within the drug storage portion 710 of the drug container 700 and injects the drug solution into the body. It has a tubular body 410 and a radius on the outer peripheral surface of the body 410. The L-shaped arms 422 and 424 extend outward, and the L-shaped arm 420 includes a locking piece 430 formed at the distal end.

One or more L-shaped arms 420 may be formed, but it is preferable that one or more pairs be formed in symmetrical positions for stable locking and balance. The L-shaped arm 420 consists of a support portion 422 extending radially outward perpendicular to the body 410 and an elastic portion 424 bent in a distal direction from the support portion 422. The elastic portion 424 has elasticity so that it can move radially inward and outward, and the elastic portion 424 moves elastically, thereby locking the elastic pieces 432 and 434 formed at the distal end of the elastic portion 424. Unlocking is possible. The elastic portion 424 is bent to form an angle of 90° or more with respect to the support portion 422, and in a state in which no force is applied, the locking piece 430 holds the locking holes 522 and 524 of the tubular extension member 500, which will be described later; In order to be inserted into the locking holes (see FIG. 7) and locked, it is preferable that the distance from the central axis is greater than the locking holes 522 and 524 (see FIG. 7) when no external force is applied.

There may be more than one locking piece 430 formed on each L-shaped arm 420, but a proximal locking piece 432 and a distal locking piece 434 are provided to increase locking reliability.

Figure 7 is a perspective view showing a tubular extension member of an automatic drug injection device according to an embodiment.

The tubular extension member 500 is coupled to the distal end 120 (see FIG. 4) of the tubular housing 100 (see FIG. 4), as described above. It is provided with a cap portion 510 that closes the distal end 120 of the tubular housing 100 (see FIG. 4) and a tubular extension 520 inserted into the interior of the tubular housing 100 (see FIG. 4). The tubular extension 520 has locking holes 522 and 524 into which the locking piece 430 (see FIG. 6) of the plunger 400 (see FIG. 6) is inserted to maintain initial locking. The location and number of locking holes 522 and 524 are provided to correspond to the location and number of locking pieces 430 (see FIG. 6).

Meanwhile, the tubular extension member 500 may further include a plunger guide portion 530 that guides the distal end of the body 410 of the plunger 400 in the initial position.

Figure 8 is a cross-sectional view showing the automatic drug injection device before drug injection according to an embodiment.

In the initial position, the second elastic member 610 is installed in a compressed state, and the proximal end of the second elastic member 610 is attached to the tubular extension member 500 inside the body 410 of the plunger 400. 2 The distal end of the elastic member 610 is supported. The second elastic member 610 is locked by inserting the locking pieces 432 and 434 of the plunger 400 into the locking holes 522 and 524 of the tubular extension member 500 in a compressed state. Despite the pressing force of 610, the plunger 400 remains stationary.

Figure 9 is a cross-sectional view showing the start of drug injection in an automatic drug injection device according to an embodiment.

When a user touches the proximal end 210 of the activation member 200 to the skin while holding the tubular housing 100 and presses it, the activation member 200 moves in the distal direction and is accommodated within the tubular housing 100, The first elastic member 300 is compressed. Accordingly, the injection needle 714 is exposed through the central hole 214 of the contact surface 212 of the proximal end 210 of the activating member 200, and the distal end of the trigger portion 220 of the activating member 200 is connected to the plunger. The locking pieces 432 and 434 of 400 are pushed radially inward. As the locking pieces 432 and 434 leave the locking holes 522 and 524 of the tubular extension member 500, a clicking sound is generated, and the user can recognize that drug injection is starting through the clicking sound. That is, the drug starting sound is generated at the same time as the locking pieces 432 and 434 of the plunger 400 and the locking holes 522 and 524 of the tubular extension member 500 are unlocked.

As the initial locking between the locking pieces 432 and 434 of the plunger 400 and the locking holes 522 and 524 of the tubular extension member 500 is released, the plunger 400 is installed in a compressed state with the second elastic member 610 ) moves in the proximal direction due to the pressing force. The plunger 400 moves in the proximal direction within the drug storage portion 712 of the drug container 710 and delivers pressing force to the drug so that the drug is injected into the body through the injection needle 714.

Figure 10 is a cross-sectional view showing the end of drug injection of the automatic drug injection device according to an embodiment.

When the plunger 400 moves all the way in the proximal direction by the pressing force of the second elastic member 610, the plunger 400 exits the tubular extension portion 520 of the tubular extension member 500. As described above, the locking pieces 432 and 434 of the plunger 400 protrude further outward in the radial direction than the outer periphery of the tubular extension 520 in a state in which no external force is applied. Accordingly, a clicking sound is generated as the proximal end of the tubular extension 520 exits. This click sound allows the user to confirm that drug injection has been completed. The click sound at this time can be defined as the drug end sound.

Figure 11 is a cross-sectional view showing the final locking of the activation member of the automatic drug injection device according to an embodiment.

After drug injection is completed, when the user separates the proximal end 210 of the activation member 200 from the skin, the external force is removed and the compressed first elastic member 300 restores the activation member 200 to its original position. I order it. That is, the activation member 200 moves toward the proximal end again. As the activation member 200 moves in the proximal direction, the locking pieces 432 and 434 are inserted into the locking hole 222 formed in the trigger portion 220, thereby generating a clicking sound.

After the locking pieces 432 and 434 are locked in the locking hole 222 formed in the trigger portion 220, their movement in the distal direction is restricted as they interfere with the proximal end of the tubular extension member 500. Accordingly, the locking pieces 432 and 434 and the locked activation member 200 are also unable to move in the distal direction. Therefore, the sound generated when the locking pieces 432 and 434 and the activation member 200 are locked can be defined as the final locking sound.

At this time, the proximal end of the tubular extension member 500 has its inner side in the proximal direction to guide the L-shaped arm 420 to move radially outward when the L-shaped arm 420 of the plunger 400 moves in the distal direction. A more extended inclined surface 526 may be provided. In addition, the L-shaped arm 420 of the plunger has an inner surface of the distal end having an inclined surface 426 corresponding to the inclined surface 526 formed at the proximal end of the tubular extension member 500. When a distal force acts on 420, it guides the tubular extension member 500 to slide to the outside. Accordingly, the L-shaped arm 420 and the locking pieces 432 and 434 of the plunger 400 are inserted again into the inner space of the tubular extension 520, so that the locking pieces 432 and 434 and the activation member 200 Locking between the locking holes 222 may be released and the plunger 400 and the activation member 200 may be prevented from moving in the distal direction.

100: tubular housing 200: activation member
210: proximal end 212: contact surface
214: Hole 220: Trigger unit
222: Locking hole 300: First elastic member
400: Plunger 410: Plunger body
420: L-shaped arm 430; 432, 434: Locking
500: tubular extension member 510: cap portion
520: tubular extension 522, 524: locking hole
530: Plunger guide part 610: Second elastic member
620: Second elastic member guide

Claims (12)

A tubular housing forming the exterior;
An activation member slidably installed within the tubular housing;
a first elastic member pressing the activating member in a proximal direction;
A tubular extension member installed at the distal end of the tubular housing;
A plunger slidably installed within the tubular extension member;
a second elastic member pressing the plunger in the proximal direction; and
A drug container is provided with an injection needle capable of injecting the drug stored in the drug storage section by infiltrating the drug storage section and the skin, the proximal end of the plunger is inserted, and the drug container is fixed to the tubular housing;
The tubular extension member has one or more locking holes, and the plunger protrudes out of the tubular extension member through the locking hole and has one or more locking pieces elastically movable in the radial direction,
The proximal end of the activation member is exposed to the outside of the tubular housing for a predetermined length, and when the proximal end slides in the distal direction of the tubular housing by an external force, the distal end of the activation member locks by pushing the locking piece of the plunger into the locking hole of the tubular extension member. An automatic drug injection device characterized in that it generates a drug starting sound upon release, and the second elastic member presses the plunger to start injecting the drug. According to paragraph 1,
When the plunger is slid to a predetermined position in the proximal direction by the second elastic member, the locking piece of the plunger comes out in the proximal direction of the proximal end of the tubular extension member, and the locking piece leaves the tubular extension member to generate a drug end sound. Characterized by an automatic drug injection device. According to paragraph 2,
The activating member has a locking hole for receiving the locking piece of the plunger that leaves the tubular extension member when the external force is removed and the first elastic member slides in the proximal direction and returns to the original position,
An automatic drug injection device characterized in that the locking piece of the plunger is inserted into the locking hole of the activation member and generates a final locking sound while locking the activation member. According to paragraph 1,
The plunger has a body and an L-shaped arm extending from the outer peripheral surface of the body,
An automatic drug injection device, characterized in that the locking piece extends radially outward from the distal end of the L-shaped arm. According to clause 4,
An automatic drug injection device, wherein the plunger locked with the activation member prevents movement of the activation member by contacting the proximal end of the tubular extension member with the L-shaped arm of the plunger even when a pressing force is applied to the distal side by the activation member. . According to clause 4,
Automatic drug injection, wherein the proximal end of the tubular extension member has an inclined surface extending further proximally on the inner side to guide the L-shaped arm of the plunger to move radially outward when the L-shaped arm of the plunger moves in the distal direction. Device. According to clause 6,
An automatic drug injection device, wherein the L-shaped arm of the plunger has a distal end having an inclined surface corresponding to an inclined surface formed at the proximal end of the tubular extension member. According to paragraph 1,
The plunger has a tubular body,
An automatic drug injection device, wherein the second elastic member has a proximal end received within the tubular body. According to clause 8,
Automatic drug injection, further comprising a second elastic member guide inserted into the distal end of the second elastic member to guide compression and expansion of the second elastic member, the distal end of which is fixed to the tubular extension member. Device. According to clause 9,
An automatic drug injection device, wherein the proximal end of the second elastic member guide is received within the tubular body. According to paragraph 1,
An automatic drug injection device further comprising a container holder fixed to the tubular housing and into which the drug container is installed. According to clause 11,
An automatic drug injection device, wherein the container holder and the tubular housing each have a window through which the amount of drug stored in the drug container can be checked.