Aids for self-injectors

Abstract

An assist device for a self-injector is provided. The assist device has a container body, a cover, and a pressing sleeve. The assist device has a first fitting portion disposed in the container body and one or more alternative fitting portions disposed in place of the first fitting portion. The first fitting portion holds the self-injector in a prescribed holding position in the first fitting portion in a detachable manner. The alternative fitting portion holds the self-injector in a prescribed alternative holding position in the alternative fitting portion in a detachable manner. The alternative holding position is at a position moved by a prescribed amount with respect to the holding position. The prescribed amount is a value set in advance based on a penetration depth corresponding to a patient. By having the first fitting portion and the alternative fitting portion, even if the length of the needle of the self-injector is different, the length of the needle protruding from the top end opening of the cover (length at the time of use) can be made constant, and the penetration depth can also be changed according to the patient.

Description

Technical Field

[0001] This invention relates to an assistive device for patients to perform self-injection using a self-injector. Background Technology

[0002] In cases such as administering insulin to diabetic patients or medications to rheumatoid arthritis patients, there are situations where patients inject themselves with pre-filled syringe formulations (syringes pre-filled with medication). Such injections are called self-injections, and the pre-filled syringe formulations used for this purpose are called self-injectors.

[0003] In the past, assistive devices for self-injectors have been proposed to enable patients to easily perform self-injections using self-injectors (e.g., Patent Documents 1-3). Conventional assistive devices are shaped to be easy for patients to operate and hold with one hand. Furthermore, in conventional assistive devices, the stop surface abuts against the skin to stop the insertion movement, thus ensuring that even when repeatedly self-injecting with a self-injector using a needle of the same length, the insertion depth of the needle remains the same.

[0004] Patent Document 1: Japanese Utility Model Registration No. 3143302

[0005] Patent Document 2: Japanese Patent Application Publication No. 2017-189515

[0006] Patent Document 3: Japanese Patent Publication No. 2017-505218

[0007] However, after conducting a more detailed study of conventional self-injectors, the inventors discovered that there are two important problems regarding the needle and insertion depth of the self-injector.

[0008] First, the first problem is that the needle length varies depending on the type of self-injector. For example, as shown in the attached diagram, Figure 18 The "FIRAZYR (registered trademark)" (manufactured by Takeda Pharmaceutical Co., Ltd., a subcutaneous injection syringe filled with a solution (containing icatibant) to stabilize acute attacks of hereditary angioedema) shown in (a) does not have a needle attached. The needle is separately provided to the patient by the medical institution that provides the FIRAZYR to the patient. Figure 18 (b) is a diagram showing the syringe with the needle installed. The needle is covered by cap 24, which is not shown in the diagram. Cap 24 is removed before use.

[0009] However, the length of the needles provided to patients varies from medical institution to institution. Examples of needle (needle) lengths include 13mm, 16mm, 19mm, and 25mm. Thus, even with the same self-injector, different needle lengths result in different insertion depths into the skin, even when using the same aid. Furthermore, some aids have sliding covers around the needle at the top to prevent the patient from seeing it (and being startled). However, if the needle length is different, even with the same aid, the needle tip may protrude from the top of the cover, making it visible to the patient. Therefore, the first problem is that even with the same self-injector, the needle length can vary.

[0010] Next, the second problem is that even when using the same self-injector (with a needle of constant length), the recommended needle insertion depth varies depending on the thickness of the patient's subcutaneous fat. For example, there are cases where doctors determine that a depth of about 13 mm is suitable for patients with thicker subcutaneous fat, while a depth of about 10 mm is suitable for patients with thinner subcutaneous fat. This second problem is completely different from the first problem mentioned above.

[0011] For the first problem, the issue is the varying needle lengths. To solve this, regardless of the needle length, the length of the needle protruding from the tip of the aid must be kept constant. In contrast, for the second problem, the issue is that the insertion depth varies from patient to patient. Even with the same needle length, the length of the needle protruding from the tip of the aid must be adjusted to suit the patient.

[0012] The first and second problems mentioned above are not only problems that arise in FIRAZYR, but also problems that can arise in other self-injectors. Summary of the Invention

[0013] The object of the present invention is to provide an aid for self-injectors that can solve the first and second problems mentioned above.

[0014] The main structure of this invention is as follows.

[0015] [1] An aid for self-injector, the aid having a container body with an elongated shape along its long side.

[0016] The container body is configured to house the self-injector in a manner that allows it to be assembled and disassembled along the aforementioned long side.

[0017] The container body has: a tip side corresponding to the needle side of the self-injector and a rear end side corresponding to the plunger side of the self-injector.

[0018] The auxiliary device has a cover disposed on the top side of the container body.

[0019] The cover can slide along the aforementioned long side between its forward and backward limits.

[0020] The cover is held at its forward limit by the force exerted by the spring component.

[0021] With the cover at its maximum forward extension, the needle of the self-injector is covered by the cover.

[0022] When the aid is applied to the patient's skin, the cover moves to its maximum retraction position, and the needle of the self-injector protrudes from the top opening of the cover.

[0023] The auxiliary device has a pressing sleeve located on the rear end side of the container body.

[0024] The compression sleeve is the part for the patient to hold in their hand, and it allows the plunger of the self-injector to slide a specified distance along the aforementioned long side.

[0025] The pressing sleeve has a pressing head inside, and is configured such that when the pressing sleeve slides towards the top of the container body, the pressing head presses the plunger head of the self-injector.

[0026] The auxiliary device has a first adapter disposed within the container body.

[0027] The first adapter is configured to hold the barrel of the self-injector in a predetermined holding position (A1) within the first adapter in a detachable manner.

[0028] The first adapter is configured to engage with the container body in a detachable manner at each of the plurality of engaging positions (Bx) within the container body.

[0029] The aforementioned multiple engagement positions (Bx) are located along the aforementioned long side direction and correspond to different lengths (Lx) of the self-injector needle.

[0030] By selecting the engagement position (Bx) based on the needle length (Lx), the length of the needle protruding from the top opening of the cover during use becomes a constant length (C1).

[0031] The first adapter is replaced by one or more alternative adapters disposed within the container body.

[0032] The replacement adapter is configured to hold the self-injector barrel in a predetermined replacement holding position (A2) within the replacement adapter in a detachable manner.

[0033] The alternative holding position (A2) is located in the aforementioned long-side direction, having been moved by a predetermined amount (k) relative to the holding position (A1). This predetermined amount (k) is a value preset based on the insertion depth corresponding to the patient, and is different for each alternative fitting.

[0034] The alternative adapter is configured to engage with the container body in a detachable manner at each of the aforementioned multiple engagement positions (Bx).

[0035] By selecting the engagement position (Bx) according to the needle length (Lx), the length of the needle protruding from the top opening of the cover during use becomes a constant length (C2) that is different from the constant length (C1) mentioned above.

[0036] [2] In the auxiliary device described in [1] above,

[0037] The structure in which the first adapter and the alternative adapter are engaged with the container body in a detachable manner at each of the above-mentioned multiple engagement positions (Bx) is any one of the structures described in (I) to (IV).

[0038] (I) On the inner surface of the container body, a plurality of recesses of the same shape are provided corresponding to a plurality of engagement positions (Bx), and a protrusion is provided on the first fitting part and the alternative fitting part to be inserted into one of the plurality of recesses.

[0039] (II) On the inner surface of the container body, a plurality of protrusions of the same shape are provided corresponding to a plurality of engagement positions (Bx), and a recess is provided on the first fitting part and the alternative fitting part for one of the plurality of protrusions to be inserted.

[0040] (III) On the first adapter and the alternative adapter, there are multiple recesses of the same shape corresponding to multiple engagement positions (Bx), and on the inner surface of the container body, there is a protrusion that is inserted into one of the multiple recesses.

[0041] (IV) On the first adapter and the alternative adapter, a plurality of protrusions of the same shape are provided corresponding to a plurality of engagement positions (Bx), and a recess is provided on the inner surface of the container body for one of the plurality of protrusions to be inserted.

[0042] [3] In the auxiliary device described in [1] or [2] above,

[0043] On the inner surface of the container body, at the display position corresponding to each of the aforementioned multiple engagement positions (Bx), text or symbols indicating the length of the self-injector needle are displayed.

[0044] The aforementioned text or symbols are located in a position covered and obscured by the first adapter and the alternative adapter.

[0045] A through-window is provided on the first adapter and the alternative adapter. Through this through-window, only the text or symbol displayed at one display position is visible.

[0046] The through-window is positioned such that, when the first adapter and the alternative adapter are engaged with the container body at each of the aforementioned engagement positions (Bx), only text or symbols indicating the length corresponding to that engagement position are visible through the through-window.

[0047] [4] In any of the auxiliary devices described in [1] to [3] above,

[0048] A locking mechanism is provided on one or both of the container body and the pressing sleeve to prevent the pressing sleeve from sliding, and the locking mechanism is provided with a lock release button that allows the pressing sleeve to slide.

[0049] [5] In the auxiliary device described in [4] above,

[0050] The aforementioned locking mechanism consists of a cantilevered tongue-shaped portion provided on the outer surface of the container body and a notch provided at the front end of the pressing sleeve.

[0051] The notch is shaped like a tongue, allowing the tongue-shaped part to enter.

[0052] The tongue-shaped portion extends towards the rear end along the aforementioned long side and enters the notch, preventing the pressing sleeve from sliding towards the top end.

[0053] The tip of the tongue-shaped part functions as a lock release button. If the tip of the tongue-shaped part is pressed from the outside, the tongue-shaped part deforms elastically in the form of a cantilever, and the tip of the tongue-shaped part sinks into the container body. Thus, the pressing sleeve can pass over the tip of the tongue-shaped part and slide towards the tip.

[0054] [6] In the auxiliary device described in [5] above,

[0055] The container body has an opening for the self-injector, the first adapter, and the alternative adapter to enter and exit, and has a cap for closing the opening.

[0056] The cantilevered tongue-shaped portion of the locking mechanism extends from the rear end face of the cover in the long side direction and enters the notch of the pressing sleeve, preventing the pressing sleeve from sliding towards the top.

[0057] [7] In any of the auxiliary devices described in any one of [1] to [5] above,

[0058] The container body has an opening for the self-injector, the first adapter and the alternative adapter to enter and exit, and has a cap for closing the opening.

[0059] In the assistive device of the present invention (hereinafter referred to simply as the assistive device), a first adapter portion for solving the first problem is provided in a detachable and movable manner within the main body (container body) constituting the assistive device. This first adapter portion moves and positions the self-injector at multiple predetermined positions within the container body. Therefore, even if the needle length changes, the insertion depth remains constant by moving the first adapter portion corresponding to the needle length, and the needle tip is prevented from protruding from the top of the cover and thus from being visible to the patient.

[0060] Furthermore, the assistive device is equipped with a replacement adapter to address the second problem. The replacement adapter replaces the first adapter and is installed within the container body. The position of the self-injector held by the replacement adapter differs from the position held by the first adapter. Therefore, even with the same needle length, the insertion depth for the patient differs between the first adapter and the replacement adapter. Thus, for example, when using the first adapter, even with different needle lengths (13mm, 16mm, 19mm, 25mm, etc.), the insertion depth for the patient can always be kept constant (13mm, etc.); and when using the replacement adapter, even with different needle lengths (13mm, 16mm, 19mm, 25mm, etc.), the insertion depth for the patient can always be kept constant (10mm, etc.).

[0061] More specifically, depending on the needle length (e.g., 13mm, 16mm, 19mm, 25mm), the first adapter and the alternative adapter are moved rearward within the container body. Furthermore, the position of the self-injector held by the alternative adapter is moved rearward by a predetermined amount (e.g., 3mm) compared to the position held by the first adapter. Therefore, the insertion depth when using the alternative adapter is, for example, 3mm shallower than the insertion depth when using the first adapter.

[0062] By having a first adapter and a replacement adapter, the assistant can solve both the first and second problems. Attached Figure Description

[0063] Figure 1 This figure shows an example of a preferred structure of the auxiliary device of the present invention. In this figure, the lid provided on the container body is open, and the interior of the container body is visible. The first adapter is shown protruding outside the container body. An alternative adapter is shown next to the first adapter. There may be multiple alternative adapters, but in this figure, only one alternative adapter is shown.

[0064] Figure 2 It means Figure 1 The diagram shows the appearance of the aid in its normal state (without pressure on the skin), and also shows it with the cap closed. A self-injector is housed inside the aid. The tip of the cap of the self-injector's needle protrudes slightly from the cover, but if the cap is removed, the needle is concealed within the cover. Figure 2 (a) is the main view of the auxiliary device. Figure 2 (b) is viewed from the right side. Figure 2 The side view of the aid shown in (a) is shown.

[0065] Figure 3 It means Figure 2 The diagram shows the appearance of the aid in use (pressed against the skin). The pressing sleeve slides to the top side, and the cover slides to the rear side. The cover is then inserted into the container body and concealed. Figure 2 In contrast, the tip of the cap on the self-injector needle is more exposed from the cover. Figure 3 (a) is the main view of the auxiliary device. Figure 3 (b) is viewed from the right side. Figure 3 The side view of the aid shown in (a) is shown.

[0066] Figure 4 Is with Figure 2 The diagram corresponding to (b) is shown for ease of understanding of the cover and the spring inside. Additionally, this diagram shows the self-injector inserted into the container body with the cover open.

[0067] Figure 5 It means in Figure 1 The diagram shows the auxiliary device with a first adapter installed inside the container body, and the self-injector is held in place within the first adapter. The device is now in the open position.

[0068] Figure 6 This diagram illustrates the function of the first adapter and the alternative adapter.

[0069] Figure 7 This is a three-dimensional diagram showing the overall shape of the aid. There is no self-injector inside, and the cap is in a closed state. Figures 1-5 Compared to the auxiliary device shown, for Figures 7 to 17 The auxiliary device shown may differ in appearance details such as whether the container body has a window, but the only difference is in appearance; its actions and functions are the same.

[0070] Figure 8 It means Figure 7The diagram of the aid shown is as follows: (a) is the front view, (b) is the right side view of (a), (c) is the rear view of (a), (d) is the left side view of (a), (e) is the top view of (a) (viewed from the rear side of the aid), and (f) is the bottom view of (a) (viewed from the top side of the aid).

[0071] Figure 9 Is with Figure 1 The corresponding perspective view. In this view, the lid attached to the container body is open, and the interior of the container body is visible. The first adapter is shown protruding outside the container body. An illustration of an alternative adapter is omitted.

[0072] Figure 10 Observation from the back end Figure 9 The diagram shown is a three-dimensional representation of the auxiliary device.

[0073] Figure 11 It means in Figure 9 The diagram shows a perspective view of the auxiliary device in which the first adapter is installed in a certain engaging position within the container body.

[0074] Figure 12 It means in Figure 11 The diagram shows a perspective view of the auxiliary device with the first adapter installed in another engaging position.

[0075] Figure 13 It means in Figure 12 The diagram shows a perspective view of the device with a self-injector installed inside. Reference numeral 25a and the dashed line indicate the tip of the plunger within the cylinder.

[0076] Figure 14 It means in Figure 13 The diagram shown is a three-dimensional representation of the auxiliary device with the lid closed.

[0077] Figure 15 It means in Figure 14 The diagram shows a perspective view of the auxiliary device in which the cover has moved to its rearward limit.

[0078] Figure 16 It means in Figure 15 The diagram shows the auxiliary device in a three-dimensional view, with the sleeve pressed and moved to the top side (when in use, the needle is inserted into the skin and the plunger of the syringe is pressed).

[0079] Figure 17 This is a three-dimensional diagram showing a patient using the aid to perform self-injection. Figure 17 (a) shows the patient holding the assistive device with their right hand and bringing it into contact with their skin. Figure 17(a) shows the patient pressing the aid onto the skin and ending the self-injection.

[0080] Figure 18 This is a diagram illustrating an example of a self-injector.

[0081] Explanation of reference numerals in the attached figures

[0082] 10... Container body; 10b... Cover; 11... Cap; 13A... First adapter; 13B... Alternate adapter; 16... Press sleeve. Detailed Implementation

[0083] Hereinafter, the structure of the auxiliary device will be described in detail with reference to the figures illustrating a preferred embodiment of the auxiliary device of the present invention. Figures 1 to 18 In this work, for the parts of the aid and the self-injector, the same reference numerals shall be appropriately used to label the parts that are the same to each other, and the same descriptions in the figures shall be omitted for these reference numerals.

[0084] This assistive device is for patient use. Figure 18 Examples of self-injectors that assist in self-injection, such as Figure 1 As shown, it is composed of at least a container body 10, a cover 10b, a pressing sleeve 16, a first adapter 13A, and one or more alternative adapters 13B.

[0085] (Container body)

[0086] The container body 10 is an elongated shape with its long side facing outwards, and its thickness is suitable for accommodating a self-injector and for easy operation by the patient. Hereinafter, when referred to simply as "long side facing outwards," it refers to the direction of the long side of the elongated shape of the container body 10. The container body 10 is configured to detachably accommodate a self-injector along its long side. If a self-injector is accommodated within the container body, the long side directions of both are aligned. This detachable structure is achieved through a first adapter and a replacement adapter. Figure 5 As shown, the container body 10 has a tip side corresponding to the needle side of the self-injector. Figure 5 The lower side) and the rear end side corresponding to the plunger side of the self-injector ( Figure 5 (the upper side).

[0087] The materials of the container body, cover, pressing sleeve, first adapter, and alternative adapter are not particularly limited, but for example, a malleable polymer material such as ABS resin (acrylonitrile-butadiene-styrene copolymer) is preferred. The materials of the container body, cover, pressing sleeve, first adapter, and alternative adapter may be the same as each other, may be different from each other, or may be materials preferred for their respective functions.

[0088] (The lid of the container body)

[0089] The container body has openings for the self-injector, the first adapter, and the alternative adapter to enter and exit. In a preferred embodiment of this aid, such as... Figure 1 As shown, a cover 11 is provided that can close the opening. This cover 11 is preferably configured to open and close around a hinge. Furthermore, in a preferred embodiment of this aid, the cover is made of a transparent material. This allows for confirmation of the presence and configuration of the self-injector inside, and also eliminates the need for... Figure 9 The small window 11d shown is used to observe the interior.

[0090] like Figure 1 As shown, in a preferred embodiment, a protrusion or rib 11f is provided on the inside of the cap for pressing the contained self-injector to prevent it from moving.

[0091] (Cover)

[0092] The cover 10b is a cylindrical component located at the top of the container body and covering the needle from all sides to prevent the patient from seeing the needle of the self-injector. For example, according to... Figure 2 (a) and Figure 3 As can be seen from (a), the cover 10b can slide along its long side between the forward limit (top side) and the backward limit (rear side). Figure 4 As shown, the cover 10b is held at its forward limit by the force exerted by the spring member 10c. When the cover 10b is at its forward limit, as... Figure 13 , Figure 14 As shown, the needle of the self-injector is covered by a cover 10b, so the patient cannot see the needle 23. On the other hand, when the aid is pressed against the patient's skin, as... Figure 15 , Figure 16 As shown, the cover 10b moves to its rearward limit, and the needle 23 of the self-injector protrudes from the top opening of the cover (i.e., enters the patient's skin).

[0093] (Press the sleeve)

[0094] The pressing sleeve 16 is disposed on the rear end side of the container body 10. This pressing sleeve 16 is the part for the patient to hold during self-injection. The pressing sleeve 16 is capable of moving a plunger relative to the container body along its long side a distance. The plunger's movement distance is predetermined. In a preferred embodiment of this aid, the pressing sleeve slides while covering the outer surface of the container body from all sides. The pressing sleeve 16 has a pressing head internally (e.g., Figure 13 (As shown by reference numeral 16c in the attached figure), when the pressing sleeve 16 slides toward the top of the container body 10, the pressing head 16c presses the plunger head 25b of the self-injector.

[0095] The structure of the pressing sleeve 16 is not particularly limited, but it can be, for example, as follows: Figures 1-5 As shown, multiple smooth recesses 16b are provided on the side of the compression sleeve 16, making it easy for the patient to hold the compression sleeve 16 and preventing the hand from sliding in the compression direction.

[0096] (First adapter section)

[0097] The first adapter 13A is disposed within the container body in a detachable manner. In this invention, for identification purposes, one of the plurality of adapters disposed within the container body in a replaceable manner is referred to as the first adapter, and the other adapters are referred to as alternative adapters, but any one of the adapters may also be referred to as the first adapter.

[0098] like Figure 5 As shown, the first adapter 13A is configured to hold the self-injector barrel in a predetermined holding position (A1) within the first adapter in a detachable manner. A particularly important element of this predetermined holding position (A1) is that it is a position predetermined in the longitudinal direction. In a preferred embodiment of this aid, the barrel barrel is held in the predetermined holding position (A1) in the longitudinal direction by utilizing the finger support flange of the barrel.

[0099] like Figure 18 As illustrated in (b), the self-injector has a barrel 21, a plunger 25, and a needle at the tip (not shown). To facilitate manual operation by the patient, the flange 22 of the barrel is often provided with a finger support flange (also called a finger gripping portion) 22a. In a preferred embodiment of this aid, such as... Figure 13 As shown, a recess for embedding a finger support flange 22a is provided on the first adapter portion, and the self-injector is positioned on the first adapter portion by holding the finger support flange 22a.

[0100] The first adapter 13A moves to multiple engagement positions (Bx) within the container body while the self-injector is in place. Consequently, the self-injector also moves to multiple engagement positions (Bx). At each of the multiple engagement positions (Bx) within the container body, the first adapter 13A engages with the container body in a detachable manner. The structure for this engagement will be described later.

[0101] (Multiple card positions (Bx))

[0102] The multiple engagement positions (Bx) are positions along the long side and correspond to different needle lengths (Lx) of the self-injector. For example, if the needle length (Lx) is 13mm, 16mm, 19mm, and 25mm, then the multiple engagement positions (Bx) are four engagement positions (B1 to B4), sequentially from the top to the rear end: the first engagement position (B1) for 13mm, the second engagement position (B2) for 16mm, the third engagement position (B3) for 19mm, and the fourth engagement position (B4) for 25mm. For example, when using a self-injector with a needle of 13mm length, the first engagement position (B1) is selected. At this time, the length of the needle protruding from the top opening of the cover is 13mm during use. Next, when using a self-injector with a needle of 16mm length, the first adapter is changed to the second engagement position (B2), and the self-injector moves 3mm towards the rear end in the long side direction within the container body. By moving the self-injector 3mm to the rear end, even with a 16mm long needle, the length of the needle protruding from the aid during use is 13mm. By selecting a predetermined appropriate engagement position (Bx) according to the needle length (Lx), the length of the needle protruding from the top opening of the cover becomes a constant length (C1) during use.

[0103] (Alternative adapter)

[0104] The alternative adapter 13B is an adapter disposed within the container body, replacing the first adapter 13A. The alternative adapter 13B within the container body functions the same as the first adapter 13A described above, and by selecting a predetermined appropriate engagement position (Bx) based on the needle length (Lx), the length of the needle protruding from the top opening of the cover becomes a constant length (C2) during use. The key point here is that the length (C2) of this protruding needle differs from the length (C1) when the first adapter 13A is used.

[0105] In the alternative adapter 13B, the self-injector barrel is held in a predetermined alternative holding position (A2) in a detachable manner. The structure for holding the barrel can also be the same as that of the first adapter, and preferably configured as described above, in which a recess for inserting a finger support flange 22a is provided on the alternative adapter, and the self-injector is positioned in the alternative adapter by holding the finger support flange 22a.

[0106] (Maintain position (A1) and alternative hold position (A2))

[0107] The key feature of the alternative adapter 13B is that the alternative holding position (A2) of the self-injector barrel differs from the holding position (A1) of the first adapter. The alternative holding position (A2) is located at a position that has been moved by a predetermined amount (k) relative to the holding position (A1) in the long side direction. This predetermined amount (k) is a value preset based on the insertion depth corresponding to the patient.

[0108] For example, when a puncture depth of 13 mm is recommended for patients with thicker subcutaneous fat, the first adapter 13A is used. In contrast, when a puncture depth of 10 mm is recommended for patients with thinner subcutaneous fat, the alternative adapter 13B is used. In this case, the alternative holding position (A2) of the alternative adapter 13B is moved 3 mm posteriorly from the holding position (A1) of the first adapter 13A.

[0109] exist Figure 1 In the example shown, the alternative adapter 13B is 3 mm longer than the first adapter 13A, and the self-injector held by the alternative adapter 13B is moved 3 mm further to the rear end than when the first adapter 13A was used. Therefore, even with the same 13 mm needle, the insertion depth (the length of the protruding needle) is 13 mm when using the first adapter, and 10 mm when using the alternative adapter.

[0110] Furthermore, even for self-injectors fitted with needles of other lengths by medical institutions, the insertion depth can always be adjusted to 13mm when using the first adapter, and can always be adjusted to 10mm when using the alternative adapter.

[0111] Multiple alternative adapters can be provided depending on the recommended insertion depth. For example, if there are three insertion depths such as 10mm, 13mm, and 16mm, two alternative adapters can be provided accordingly. For example, by using a first adapter (insertion depth 10mm) and two alternative adapters (insertion depths 13mm and 16mm), a total of three insertion depths (10mm, 13mm, and 16mm) can be accommodated.

[0112] Figure 6 The diagram is shown to make it easier to understand the difference in function between the first adapter 13A and the alternative adapter 13B.

[0113] Figure 6 In (a), the length of the needle provided by the medical institution is L1, and the indicated insertion depth (the length of the needle protruding from the top opening of the cover 10b) is C1. Figure 6 In (a), a first adapter 13A is used, which is located in the first engaging position (B1).

[0114] Figure 6 In (b), the length of the needle provided by the medical institution is L2 (L1 < L2), and the indicated insertion depth is... Figure 6 (a) is the same as C1. Figure 6 In (b), the first adapter 13A is used, but the first adapter 13A is in the second engaging position (B2), and the self-injector moves to the rear end side. As a result, the insertion depth is adjusted to C1.

[0115] Figure 6 In (c), the length of the needle provided by the medical institution is the same as... Figure 6 (a) is the same as L1, but the indicated insertion depth is C2 (C2 < C1). Figure 6 In (c), a replacement adapter 13B is used, therefore, the barrel 21 of the self-injector is located in a position relative to... Figure 6 (a) The position on the rear end side. In addition, the alternative adapter 13B is located in the first engaging position (B1). As a result, the insertion depth is adjusted to C2.

[0116] Figure 6 In (d), the length of the needle provided by the medical institution is L2 (L1 < L2), and the indicated insertion depth is... Figure 6 (c) is the same as C2. Figure 6 In step (d), an alternative adapter 13B is used, but this alternative adapter 13B is in the second engaging position (B2), and the self-injector moves to the rear end side. As a result, the insertion depth is adjusted to C2.

[0117] (Structure that changes the engagement position of the adapter)

[0118] There are no particular limitations on the structure in which the first adapter and the alternative adapter are detachably engaged with the container body at each of the aforementioned engagement positions (Bx). However, as long as the structure is one in which the concave and convex parts interlock and engage, the construction is simple and therefore preferred. Examples of such structures are shown below (I) to (IV).

[0119] (I)If Figure 6 As shown, the configuration is such that multiple recesses of the same shape are provided on the inner surface of the container body, corresponding to multiple engagement positions (Bx), and a protrusion that is inserted into one of the multiple recesses is provided in the first adapter and the alternative adapter.

[0120] The structure is also shown in Figure 1 , Figure 4 , Figure 5 , Figures 9-13 .

[0121] Alternatively, in the case where the aforementioned recesses are arranged at equal intervals along the long side, like the rack of a gear, the protrusions are also arranged at equal intervals along the long side, like the rack of a gear. Furthermore, the protrusions entering a recess can also be divided into multiple parts. Adding such multiple protrusions also falls under the category of "a structure having a protrusion that is embedded into one of a plurality of recesses" as described here.

[0122] (II) is configured such that, in contrast to the recess in (I) above, a plurality of protrusions of the same shape are provided on the inner surface of the container body corresponding to a plurality of engagement positions (Bx), and a recess is provided in the first fitting part and the alternative fitting part for one of the plurality of protrusions to be inserted.

[0123] In this case, it is also possible that, in the case where the aforementioned multiple protrusions are arranged at equal intervals along the long side, like the rack of a gear, the recesses are also arranged at equal intervals along the long side, like the rack of a gear. Alternatively, it is also possible that the protrusions and recesses are divided into multiple structures. Adding such multiple recesses also falls under the category of "a structure having a recess into which one of the multiple protrusions is inserted" as described here.

[0124] (III) The first adapter and the alternative adapter are provided with a plurality of recesses of the same shape corresponding to a plurality of engagement positions (Bx), and a protrusion is provided on the inner surface of the container body to be inserted into one of the plurality of recesses.

[0125] In this case, similar to (I) above, multiple protrusions are added to the inner surface of the container body, which also falls under the category of "a structure in which a protrusion is provided to be embedded into one of the multiple recesses" as mentioned here.

[0126] (IV) In contrast to (III) above, the first adapter and the alternative adapter are provided with a plurality of protrusions of the same shape corresponding to a plurality of engagement positions (Bx), and a recess is provided on the inner surface of the container body for one of the plurality of protrusions to be inserted.

[0127] In this case, similar to (II) above, multiple recesses are added to the inner surface of the container body, which also falls under the category of "a structure in which one of the multiple protrusions is inserted into a recess" as mentioned here.

[0128] (A through-window showing the length of the needle)

[0129] In the preferred manner of this aid, such as Figure 1As shown, on the inner surface of the container body 10, and at the display positions corresponding to each of the aforementioned multiple engagement positions (Bx), there is a text (or symbol) 101 indicating the length of the needle of the self-injector. Figure 1 In the example, the needle lengths of the self-injector (13, 16, 19, 25) are displayed at intervals corresponding to their lengths. For example, the number "16" is located 3mm further back than the number "13". These words (or symbols) 101 can also be printed directly on the container body, but as... Figure 1 Therefore, it is simpler and more preferable to attach the sheet printed with these words (or symbols) 101 to the inner surface of the container body.

[0130] When one of the first adapter 13A and the alternative adapter 13B is installed inside the container body, the aforementioned text (or symbol) 101 is in a position covered and obscured by the first adapter 13A and the alternative adapter 13B.

[0131] On the other hand, a through-window 131 and 132 are respectively provided in the first adapter and the alternative adapter, through which only text (or symbols) displayed at one display position are visible. Furthermore, the through-windows 131 and 132 are positioned such that, when one of the first adapter 13A and the alternative adapter 13B is engaged with the container body at each of the aforementioned multiple engagement positions (Bx), only text (or symbols) indicating the length of the needle corresponding to that engagement position are visible through the through-windows 131 and 132. For example, Figure 1 In the example, when the needle length is 13mm and the insertion depth is 13mm, the first adapter 13A is positioned in one of the engagement positions (Bx). At this time, the through window 131 is aligned with the position of "13" in the text 101, and the patient can only see "13". Alternatively, when the needle length is 13mm and the insertion depth is 10mm, the alternative adapter 13B is positioned in one of the engagement positions (Bx). At this time, the through window 132 is aligned with the position of "13" in the text 101, and the patient can only see "13".

[0132] (Locking mechanism to prevent slippage)

[0133] A locking mechanism is provided on one or both of the container body and the compression sleeve to prevent the compression sleeve from sliding. According to this locking mechanism, when the patient holds the compression sleeve and presses the aid against the skin during use, the force towards the compression sleeve is transmitted directly to the container body, causing the top-side cover to slide to the rear-side and initiating needle insertion. If the cover slides to its rearward limit, the insertion to the prescribed depth ends.

[0134] The locking mechanism is equipped with a lock release button that allows the press sleeve to slide. If the patient operates the lock release button after insertion, the press sleeve can slide, and the patient's force moves the press sleeve to the top side, pressing the plunger to inject the medication.

[0135] (Preferred method for locking mechanism)

[0136] A preferred embodiment of the aforementioned locking mechanism is one consisting of a cantilevered tongue-shaped portion provided on the outer surface of the container body and a notch provided at the front end of the pressing sleeve. The tongue-shaped portion may also be provided at a location on the outer surface of the container body, but a more preferred embodiment is... Figure 1 The method shown is to set it on cover 11.

[0137] like Figure 1 As shown, the notch 16a at the front end of the pressing sleeve 16 is tongue-shaped, allowing the tongue-shaped portion 11e to enter. This tongue-shaped portion 11e extends towards the rear end along its long side. When the cover is closed, it is as follows... Figure 2 As shown, the tongue-shaped portion 11e enters the notch portion 16a, hindering the sliding of the pressing sleeve 16 towards the top.

[0138] The tip of the tongue-shaped portion 11e ( Figure 2 The part shown as "PUSH" in (a) functions as a lock release button. When the tip of the tongue-shaped part 11e is pressed from the outside (i.e., if the patient presses it with their thumb, etc.), the tongue-shaped part 11e elastically deforms like a leaf spring, and the tip of the tongue-shaped part 11e sinks into the container body 10. Thus, as... Figure 3 As shown, the pressing sleeve 16 can pass through the outer surface of the tongue and slide towards the top side.

[0139] For a structure that releases the lock by pressing the release button into the container body, the direction of the force exerted by the fingers (especially the thumb) when holding the aid with one hand is the same as the direction of the force exerted when pressing the release button. Therefore, it is easier and more preferable to hold the aid with one hand, press the sleeve 16, and press the release button with the thumb of that hand.

[0140] The following describes an example of the use of this aid, with reference to the accompanying drawings.

[0141] like Figure 9 , Figure 10 As shown, a protrusion 14 is provided on the lower side of the top end of the first adapter 13A, which can be inserted into any one of the recesses 12a of the engaging portion 12 on the container body side. Figure 9As shown, engaging claws 15 (one engaging claw 15a and the other engaging claw 15b) are provided on the inner surface of the container body 10. If the protrusion 14 of the adapter portion 13 of the container body 10 is engaged with any of the recesses 12a of the engaging portion 12, then the engaging claw 15 engages with the first adapter portion 13A, and the first adapter portion 13A is fixed inside the container body. The construction of the locking portion 15 is not particularly limited, however, for example, as... Figure 9 As shown, an example is illustrated by a structure that protrudes vertically from both sides of the inner surface near the center of the container body 10 and holds the first adapter 13A that has entered the container body 10.

[0142] like Figure 11 As shown, doctors, nurses, etc., in a preferred medical institution open the cover 11 and insert the protrusion 14 of the first adapter 13A into any one of the recesses 12a in the engaging portion 12 of the container body 10. Then, as... Figure 13 As shown, during injection, the patient fixes the barrel 21 of the self-injector 20 and the finger support flange 22 on the first adapter 13A.

[0143] Here, as Figure 11 , Figure 12 As shown, by inserting the protrusion 14 of the first adapter 13A into any one of the recesses 12a in the engaging portion 12, the fixed position of the first adapter 13A can be adjusted along its long side. By adjusting the position of the first adapter 13A, the self-injector can be fixed in an appropriate position within the container body 10 corresponding to the length of the needle, thus always achieving a constant insertion depth. The same applies when a substitute adapter is used instead of the first adapter 13A to achieve other insertion depths.

[0144] For example, when the needle is long, by inserting the protrusion 14 of the first adapter 13A into the recess 12a on the rear end side of the plurality of recesses 12a of the engaging part 12, the first adapter 13A is located on the rear end side, and the needle of the self-injector is also hidden near the opening of the cover. Figures 13-16 The image shows the state in which the cap 24 covers the needle 23 of the self-injector.

[0145] On the other hand, when the needle is short, by inserting the protrusion 14 of the first adapter 13A into the recess 12a near the top side of the plurality of recesses 12a of the engaging part 12, the first adapter 13A is located on the top side, and the needle of the self-injector is also hidden near the opening of the cover.

[0146] Next, as Figure 14 , Figure 17 As shown in (a), the patient closes the mask 11, removes the cap 24 of the self-injector needle, presses the tip of the aid against the skin, and inserts the needle. Figure 14 (The image shows the state where cap 24 covers needle 23). Figure 15 As shown, the cover 10b moves to its rearward limit under pressure and enters the container body, and the needle 23 of the self-injector pierces the skin. Then, the patient presses the locking release button at the tip of the tongue 11e with their thumb while... Figure 16 , Figure 17 As shown in (b), the pressing sleeve 16 is pushed toward the top side to slide it, so that the plunger of the self-injector is pressed by the pressing head inside the pressing sleeve 16, injecting the drug solution subcutaneously.

[0147] The preferred shapes of the container body 10 and the cover 11 are those that allow the patient to easily store and operate the self-injector. The preferred cross-sectional shape of the compression sleeve (the shape of the cross-section perpendicular to the long side) is one that is easy to hold with the hand (especially with one hand), for example, preferably... Figure 8 The shape can be an oblong, elliptical, or circular shape, as shown in (e) and (f). The major axis of the oblong is not particularly limited, but is preferably around 56mm to 50mm. The minor axis of the oblong is not particularly limited, but is preferably around 34mm to 30mm. The overall length of the auxiliary device in normal operation is appropriately determined based on the self-injector, for example, around 281mm to 275mm. Figure 1 In this method, it is approximately 278mm.

[0148] exist Figures 7 to 17 In the arrangement shown, a window 11d is provided between the top and center of the cover 11. This allows the interior of the container body 10 to be viewed through the window 11d, thus enabling confirmation that the self-injector is inside the container body 10. Furthermore, as described above, by making the cover 11 entirely transparent, it is easier to confirm the presence and status of the self-injector.

[0149] The structure of the engaging part 12 is not particularly limited, but it can also be, for example, Figure 5 , Figure 6 As shown, protrusions with cross-sectional shapes of quadrilaterals and triangles are arranged at predetermined intervals along the long side, thereby creating recesses 12a between the protrusions. The number of these recesses 12a is not particularly limited.

[0150] The construction of the first adapter 13A and the alternative adapter 13B is not particularly limited, but it is preferable to have a retaining structure that prevents the barrel of the self-injector from shifting laterally along its long side. For example, as Figure 9 As shown, the preferred configuration includes: a rectangular frame 13a for receiving and holding the body of the self-injector; and a plate 13b for receiving and holding the finger grip portion of the body, or it may be a tray-like shape that holds the entire body of the body of the body in such a long way.

[0151] Industrial availability

[0152] This invention is useful as an aid for patients to self-inject using self-injectors such as pre-filled syringe preparations, and is particularly effective for self-injectors where needle lengths vary depending on the medical institution.

[0153] In this assistive device, each adapter, which has a first adapter and one or more alternative adapters in a manner that allows them to be interchanged, can move equally within the container body. Moreover, the positions of the self-injector held by each adapter are different from each other, each corresponding to multiple insertion depths that vary depending on the patient.

[0154] Based on these characteristics, the first problem, such as the needle length varying depending on the medical institution, can be solved, and the second problem, such as the recommended insertion depth varying depending on the thickness of the patient's subcutaneous fat, can be solved.

Claims

1. An assist device for a self-injector, characterized by comprising: a container main body having an elongated shape with a longitudinal direction; the container main body configured to house the self-injector so as to be detachable along the longitudinal direction; the container main body having a tip end side corresponding to a needle side of the self-injector and a rear end side corresponding to a plunger side of the self-injector; the assist device having a cover sleeve provided at the tip end side of the container main body; the cover sleeve being slidable along the longitudinal direction between an advanced limit and a retreated limit; the cover sleeve being biased by a spring member to be located at the advanced limit; the needle of the self-injector being covered by the cover sleeve when the cover sleeve is located at the advanced limit; the needle of the self-injector protruding from a tip end opening of the cover sleeve when the assist device is used with the cover sleeve moved to the retreated limit by pressing against a patient's skin; the assist device having a pressing sleeve provided at the rear end side of the container main body; the pressing sleeve being a portion for the patient to hold by hand and being slidable along the longitudinal direction by a prescribed movement distance of the plunger of the self-injector; the pressing sleeve having a pressing head inside and being configured to press a plunger head of the self-injector when the pressing sleeve is slid toward the tip end side of the container main body; the assist device having a first adapter portion disposed inside the container main body; the first adapter portion being configured to hold a barrel of the self-injector at a prescribed holding position inside the first adapter portion in a detachable manner; the first adapter portion being configured to be detachably engaged with the container main body at a plurality of engagement positions (Bx) inside the container main body; the plurality of engagement positions (Bx) being located at positions along the longitudinal direction and corresponding to different lengths (Lx) of the needle of the self-injector; a length of the needle protruding from the tip end opening of the cover sleeve when the assist device is used being a constant length (C1) by selecting the engagement positions (Bx) in accordance with the lengths (Lx) of the needle; the assist device having one or more alternative adapter portions disposed inside the container main body instead of the first adapter portion; the alternative adapter portions being configured to hold the barrel of the self-injector at prescribed alternative holding positions inside the alternative adapter portions in a detachable manner; the alternative holding positions being located at positions moved by a prescribed amount in the longitudinal direction with respect to the holding position, the prescribed amount being a value preset based on a penetration depth corresponding to the patient and being a value different for each alternative adapter portion; the alternative adapter portions being configured to be detachably engaged with the container main body at the plurality of engagement positions (Bx); a length of the needle protruding from the tip end opening of the cover sleeve when the assist device is used being a constant length (C2) different from the constant length (C1) by selecting the engagement positions (Bx) in accordance with the lengths (Lx) of the needle.

2. The assist device according to claim 1, characterized in that: the first adapter portion and the alternative adapter portions are configured to be detachably engaged with the container main body at the plurality of engagement positions (Bx) in any one of the following structures (I) to (IV): ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ (I) a plurality of recesses of the same shape are provided on the inner surface of the container body in correspondence with the plurality of engagement positions (Bx), and a protrusion that is to be fitted into one of the plurality of recesses is provided on the first adapter and the alternative adapter; (II) a plurality of protrusions of the same shape are provided on the inner surface of the container body in correspondence with the plurality of engagement positions (Bx), and a recess into which one of the plurality of protrusions is to be fitted is provided on the first adapter and the alternative adapter; (III) a plurality of recesses of the same shape are provided on the first adapter and the alternative adapter in correspondence with the plurality of engagement positions (Bx), and a protrusion that is to be fitted into one of the plurality of recesses is provided on the inner surface of the container body; (IV) a plurality of protrusions of the same shape are provided on the first adapter and the alternative adapter in correspondence with the plurality of engagement positions (Bx), and a recess into which one of the plurality of protrusions is to be fitted is provided on the inner surface of the container body.

3. The aid according to claim 1 or 2, wherein a character or a symbol indicating the length of the needle of the auto-injector is displayed on the inner surface of the container body at a display position corresponding to each of the plurality of engagement positions (Bx), the character or the symbol is in a position that is covered and hidden by the first adapter and the alternative adapter, a through window is provided on the first adapter and the alternative adapter, and only the character or the symbol displayed at one display position is visible through the through window, and the through window is in a position such that, when the first adapter and the alternative adapter are engaged with the container body at each of the plurality of engagement positions (Bx), only the character or the symbol indicating the length of the needle corresponding to the engagement position is visible through the through window.

4. The aid according to claim 1 or 2, wherein a lock mechanism that hinders the sliding of the pressing sleeve is provided on one or both of the container body and the pressing sleeve, and a lock release button that allows the sliding of the pressing sleeve is provided in the lock mechanism.

5. The aid according to claim 4, wherein the lock mechanism is composed of a tongue-like portion provided on the outer surface of the container body in a cantilevered manner and a notch portion provided on the front end portion of the pressing sleeve, the notch portion is shaped so as to allow the entry of the tongue-like portion, the tongue-like portion extends toward the rear end side in the long direction and enters the notch portion, thereby hindering the sliding of the pressing sleeve toward the tip end side, the tip end portion of the tongue-like portion is a portion that functions as the lock release button, and if the tip end portion of the tongue-like portion is pressed from the outside, the tongue-like portion elastically deforms in a cantilevered manner, the tip end portion of the tongue-like portion sinks into the container body, and thus the pressing sleeve can pass over the tip end portion of the tongue-like portion and slide toward the tip end side.

6. The aid according to claim 5, wherein the container body has an opening for the entry and exit of the auto-injector, the first adapter, and the alternative adapter, and has a lid that closes the opening. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ The cantilevered tongue in the locking mechanism extends in the long direction from the rear end surface of the cap and into the notch of the press sleeve, obstructing the sliding of the press sleeve toward the tip end.

7. The aid according to claim 1 or 2, characterized in that The container body has an opening for the passage of the auto-injector, the first adapter, and the alternative adapter, and has a cap that closes the opening.

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