Autoinjector aids

Abstract

To provide an aid for an auto-injector that can cause the length of a needle protruding from the tip of the aid to be constant, and change the length of the needle protruding from the tip of the aid to the length suitable for a patient.SOLUTION: An aid includes a first adapter and an alternative adaptor disposed in a container body. The first adaptor detachably holds an auto-injector at a predetermined holding position in the first adaptor. The alternative adaptor detachably holds the auto-injector at a predetermined alternative holding position in the alternative adaptor. The alternative holding position is a position moved from the holding position by a predetermined amount. The predetermined amount is a value preset on the basis of a puncture depth for a patient. By having the first adaptor and the alternative adaptor, the length of a needle protruding from a tip opening of a cover sleeve (the length in use) can be made constant even when the length of needles of the auto-injector is different. Moreover, the puncture depth can be changed depending on the patient.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to an assisting tool for a patient to perform self-injection using an autoinjector. [Background technology]

[0002] When administering insulin to diabetic patients or medication to rheumatoid arthritis patients, patients may inject the medication themselves using a prefilled syringe (a syringe prefilled with the medication). This type of injection is called self-injection, and the prefilled syringe used for this purpose is called an autoinjector.

[0003] Auxiliary devices for autoinjectors have been proposed to enable patients to easily self-inject using an autoinjector (e.g., Patent Documents 1 to 3). Conventional auxiliary devices have a shape that allows them to be easily held in one hand, making them easy for patients to handle. Furthermore, conventional auxiliary devices have a stopper surface that abuts against the skin, stopping the movement for puncturing. This ensures that the puncture depth of the injection needle is always the same even when self-injections are repeated using autoinjectors with needles of the same length. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Utility Model Registration No. 3143302 [Patent Document 2] Japanese Patent Application Laid-Open No. 2017-189515 [Patent Document 3] Special Publication No. 2017-505218 Summary of the Invention [Problem to be solved by the invention]

[0005] However, when the inventors of the present invention examined conventional self-injectors in more detail, they found that there are the following two important problems regarding the needle and the puncture depth of self-injectors.

[0006] First, the first problem is that the length of the needle is not constant depending on the type of self-injector. For example, in the case of "Filladril (registered trademark)", a pre-filled syringe preparation shown in Fig. 18(a) (a subcutaneous injection preparation filled with a chemical solution (containing icatibant) for calming acute attacks of hereditary angioedema, manufactured by Takeda Pharmaceutical Company Limited), as shown in the figure, no needle is attached. The needle is separately given to the patient by the medical institution that administers Filladril to the patient. Fig. 18(b) is a diagram showing the state where the needle is attached to the syringe. The needle is covered with a cap 24 and the needle is not visible in the figure. The cap 24 is removed during use.

[0007] However, the length of the needle given to the patient may vary depending on the medical institution. Examples of the length of the needle (needle tube) include 13 mm, 16 mm, 19 mm, 25 mm, etc. Thus, even with the same self-injector, if the length of the needle is different, the puncture depth into the skin will also be different even when using the same auxiliary tool. Also, in order to prevent the needle from being visible to the patient (so that the needle does not give the patient a sense of fear), a slidable cover sleeve that covers the periphery of the needle may be provided on the tip side of the auxiliary tool. However, if the length of the needle is different, even when using the same auxiliary tool, the tip of the needle may protrude from the tip of the cover sleeve and the tip of the needle may be visible to the patient. Thus, the fact that the length of the needle is different even with the same self-injector is the first problem.

[0008] Next, the second problem is that even in the case of an injection using the same self-injector (always a needle of a constant length), the recommended puncture depth of the needle may vary depending on the thickness of the patient's subcutaneous fat. For example, in some cases, doctors may judge that a puncture depth of about 13 mm is suitable for patients with thicker subcutaneous fat, and a puncture depth of about 10 mm is suitable for patients with thinner subcutaneous fat. This second problem is completely different from the first problem described above.

[0009] The first problem is that the lengths of the needles are different. To solve this problem, regardless of the length of the needle, the length that the needle protrudes from the tip of the auxiliary tool must be made constant. On the other hand, the second problem is that the puncture depth varies depending on the patient. Even if the needles are of the same length, the length that the needle protrudes from the tip of the auxiliary tool must be changed to a length suitable for the patient.

[0010] The above-mentioned first and second problems can occur not only with Fillajir but also with other self-injectors.

[0011] An object of the present invention is to provide an auxiliary tool for a self-injector that can solve the above-mentioned first and second problems.

Means for Solving the Problems

[0012] The main configuration of the present invention is as follows. [1] An auxiliary tool for a self-injector, the auxiliary tool comprising: having a long container body with a longitudinal direction, the container body is configured to removably accommodate the self-injector along the longitudinal direction, the container body has a tip side corresponding to the side of the needle of the self-injector and a rear end side corresponding to the side of the plunger of the self-injector; having a cover sleeve provided on the tip side of the container body, the cover sleeve is slidable between a forward limit and a rearward limit along the longitudinal direction, the cover sleeve is biased by a spring member so as to be positioned at the forward limit, when the cover sleeve is positioned at the forward limit, the needle of the self-injector is covered by the cover sleeve, when the auxiliary tool is pressed against the patient's skin during use, the cover sleeve moves to the rearward limit so that the needle of the self-injector protrudes from the tip opening of the cover sleeve; It has a pressing sleeve provided on the rear end side of the container body, The pressing sleeve is a part for the patient to hold by hand and is slidable along the longitudinal direction by a predetermined moving distance of the plunger of the self-injector. The pressing sleeve has a pressing head inside, and when the pressing sleeve slides toward the tip side of the container body, the pressing head is configured to push the plunger head of the self-injector; It has a first adapter disposed in the container body, The first adapter is configured to detachably hold the cylinder of the self-injector at a predetermined holding position (A1) within the first adapter. The first adapter is configured to detachably engage with the container body at each of a plurality of engagement positions (Bx) within the container body. The plurality of engagement positions (Bx) are along the longitudinal direction and are at positions corresponding to different lengths (Lx) of the needle of the self-injector. By selecting the engagement position (Bx) according to the length (Lx) of the needle, the length of the needle protruding from the tip opening of the cover sleeve during use becomes a constant length (C1). It has one or more alternative adapters disposed in the container body instead of the first adapter. The alternative adapter is configured to detachably hold the cylinder of the self-injector at a predetermined alternative holding position (A2) within the alternative adapter. The alternative holding position (A2) is at a position moved by a predetermined amount (k) in the longitudinal direction from the holding position (A1), and the predetermined amount (k) is a value preset based on the puncture depth according to the patient and is a different value for each alternative adapter. The alternative adapter is configured to detachably engage with the container body at each of the plurality of engagement positions (Bx). By selecting the engagement position (Bx) according to the length (Lx) of the needle, the length of the needle protruding from the tip opening of the cover sleeve during use becomes a constant length (C2) different from the constant length (C1). [2] The auxiliary tool according to [1], The configuration in which the first adaptor and the alternative adaptor detachably engage with the container body at each of the plurality of engagement positions (Bx) is any one of the following configurations (I) to (IV). (I) A configuration in which a plurality of recesses of the same shape are provided on the inner surface of the container body in accordance with a plurality of engagement positions (Bx), and the first adapter and the alternative adapter are provided with one protrusion that fits into one of the plurality of recesses. (II) A configuration in which a plurality of convex portions of the same shape are provided on the inner surface of the container body in accordance with a plurality of engagement positions (Bx), and the first adapter and the alternative adapter are provided with a single concave portion into which one of the plurality of convex portions fits. (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 the inner surface of the container body is provided with one protrusion that fits into one of the plurality of recesses. (IV) The first adapter and the alternative adapter are provided with multiple convex portions of the same shape corresponding to multiple engagement positions (Bx), and the inner surface of the container body is provided with one recess into which one of the multiple convex portions fits. [3] The assistive device according to [1] or [2] above, a character or symbol indicating the needle length of the autoinjector is marked on the inner surface of the container body at a marking position corresponding to each of the plurality of engagement positions (Bx); the letters or symbols are in a position that is covered and hidden by the first adapter and the alternative adapter; The first adapter and the alternative adapter are provided with a through-hole through which only the characters or symbols displayed at one display position are visible; and The through window is positioned so that when the first adapter and the alternative adapter engage with the container body at each of the plurality of engagement positions (Bx), only the letter or symbol indicating the needle length corresponding to that engagement position is visible through the through window. [4] The assisting device according to any one of [1] to [3], One or both of the container body and the pressing sleeve are provided with a locking mechanism that prevents the sliding of the pressing sleeve, and the locking mechanism is provided with an unlocking button that enables the sliding of the pressing sleeve. [5] The auxiliary tool according to [4] above, The locking mechanism is composed of a cantilevered tongue-shaped portion provided on the outer surface of the container body and a notch provided at the front end portion of the pressing sleeve. The shape of the notch is tongue-shaped so that the tongue-shaped portion can enter. The tongue-shaped portion extends toward the rear end side along the longitudinal direction, enters the notch, and prevents the pressing sleeve from sliding toward the front end side. The tip of the tongue-shaped portion is a portion that functions as an unlocking button. When the tip of the tongue-shaped portion is pressed from the outside, the tongue-shaped portion elastically deforms as a cantilever, and the tip of the tongue-shaped portion sinks into the container body. As a result, the pressing sleeve can pass over the tip of the tongue-shaped portion and slide toward the front end side. [6] The auxiliary tool according to [5] above, The container body has an opening for the entry and exit of the self-injector, the first adapter, and the alternative adapter, and has a lid for closing the opening. The cantilevered tongue-shaped portion in the locking mechanism extends longitudinally from the rear end surface of the lid, enters the notch of the pressing sleeve, and prevents the pressing sleeve from sliding toward the front end side. [7] The auxiliary tool according to any one of [1] to [5] above, The container body has an opening for the entry and exit of the self-injector, the first adapter, and the alternative adapter, and has a lid for closing the opening.

Advantages of the Invention

[0013] In the assisting device of the present invention (hereinafter, also simply referred to as the assisting device), a first adapter for solving a first problem is detachably and movably provided in a main body (container main body) constituting the assisting device. By this first adapter, the self-injector is moved and positioned at a plurality of predetermined positions within the container main body. Thereby, even if the length of the needle changes, by moving the first adapter according to the length of the needle, the puncture depth becomes constant, and it can be prevented that the tip of the needle protrudes from the tip of the cover sleeve and is visible to the patient.

[0014] Further, the assisting device is provided with an alternative adapter for solving a second problem. The alternative adapter is mounted within the container main body in place of the first adapter. The position of the self-injector held by this alternative adapter is different from the position of the self-injector held by the first adapter. Thereby, even with the same needle length, the puncture depth for the patient is different between the first adapter and the alternative adapter. Thus, for example, when using the first adapter, even if the needle lengths are different such as 13 mm, 16 mm, 19 mm, 25 mm, etc., the puncture depth for the patient can always be made constant (such as 13 mm), and when using the alternative adapter, even if the needle lengths are different such as 13 mm, 16 mm, 19 mm, 25 mm, etc., the puncture depth for the patient can always be made constant (such as 10 mm).

[0015] More specifically, according to the needle length (for example, 13 mm, 16 mm, 19 mm, 25 mm), the first adapter and the alternative adapter each move toward the rear end side within the container main body. And the position of the self-injector held by the alternative adapter moves toward the rear end side by a predetermined amount (for example, 3 mm) more than the position of the self-injector held by the first adapter. Thus, the puncture depth when using the alternative adapter is, for example, 3 mm shallower than the puncture depth when using the first adapter.

[0016] By providing the first adapter and the alternative adapter, the assisting device can solve the second problem while solving the first problem. [Brief explanation of the drawings]

[0017]

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Figure 18

BEST MODE FOR CARRYING OUT THE INVENTION

[0018] Hereinafter, with reference to the drawings exemplifying preferred embodiments of the auxiliary tool of the present invention, the configuration of the auxiliary tool will be described in detail. In FIGS. 1 to 18, the same reference numerals are appropriately assigned to the same parts of the auxiliary tool and the self-injector, and the same description for these reference numerals for each figure is omitted.

[0019] The auxiliary tool is an auxiliary tool for a patient to perform self-injection using a self-injector as exemplified in FIG. 18, and as shown in FIG. 1, it is configured to include at least a container body 10, a cover sleeve 10b, a pressing sleeve 16, a first adapter 13A, and one or more alternative adapters 13B.

[0020] (Container body) The container body 10 has an elongated shape with a longitudinal direction, and has a thickness capable of accommodating a self-injector and a thickness that is easy for a patient to handle. Hereinafter, when simply referring to the "longitudinal direction", it means the longitudinal direction of the elongated shape of the container body 10. The container body 10 is configured to removably accommodate a self-injector along the longitudinal direction. When the self-injector is accommodated in the container body, the longitudinal directions of both coincide. This detachable configuration is achieved by the first adapter and the alternative adapter. As shown in FIG. 5, the container body 10 has a front end side (the lower side in FIG. 5) corresponding to the needle side of the self-injector and a rear end side (the upper side in FIG. 5) corresponding to the plunger side of the self-injector.

[0021] The materials of the container body, the cover sleeve, the pressing sleeve, the first adapter, and the alternative adapter are not particularly limited, but for example, moldable polymer materials such as ABS resin (acrylonitrile-butadiene-styrene copolymer resin) are preferable. The materials of the container body, the cover sleeve, the pressing sleeve, the first adapter, and the alternative adapter may be the same as each other, or may be different from each other, and materials preferable for their respective functions may be used.

[0022] (Cover of the container body) The container body has an opening for the entry and exit of the self-injector, the first adapter, and the alternative adapter. In a preferred embodiment of the auxiliary tool, as shown in FIG. 1, a lid 11 for closing the opening is provided. The lid 11 preferably has a configuration that opens and closes around a hinge. Also, in a preferred embodiment of the auxiliary tool, the lid is made of a transparent material. Thereby, it is possible to confirm the presence or absence and arrangement state of the internal self-injector, and it is also possible to omit the small window 11d for viewing the inside as shown in FIG. 9.

[0023] As shown in FIG. 1, in a preferred embodiment, protrusions or ribs 11f are provided on the inside of the lid to hold the accommodated self-injector so that it does not move.

[0024] (Cover sleeve) The cover sleeve 10b is provided on the distal end side of the container body, and is a cylindrical member that covers the periphery of the needle of the auto-injector so that the needle is not visible to the patient. As is apparent from FIGS. 2(a) and 3(a), for example, the cover sleeve 10b is slidable along the longitudinal direction between the forward limit (distal end side) and the backward limit (rear end side). As shown in FIG. 4, the cover sleeve 10b is biased by a spring member 10c so as to be positioned at the forward limit. When the cover sleeve 10b is positioned at the forward limit, as shown in FIGS. 13 and 14, the needle of the auto-injector is covered by the cover sleeve 10b, and the needle 23 is not visible to the patient. On the other hand, when the aid is pressed against the patient's skin during use, as shown in FIGS. 15 and 16, the cover sleeve 10b moves to the backward limit, and the needle 23 of the auto-injector protrudes from the distal end opening of the cover sleeve (i.e., enters the patient's skin).

[0025] (Pressing sleeve) The pressing sleeve 16 is provided on the rear end side of the container body 10. The pressing sleeve 16 is a portion for the patient to grasp by hand when performing self-injection. The pressing sleeve 16 is slidable along the longitudinal direction with respect to the container body by the moving distance of the plunger. The moving distance of the plunger is predetermined. In a preferred embodiment of the aid, the pressing sleeve slides while covering the outer periphery of the body of the container body. The pressing sleeve 16 has a pressing head (for example, the portion indicated by reference numeral 16c in FIG. 13) inside, and when the pressing sleeve 16 slides toward the distal end side of the container body 10, the pressing head 16c presses the plunger head 25b of the auto-injector.

[0026] The configuration of the pressing sleeve 16 is not particularly limited. For example, as shown in FIGS. 1 to 5, a plurality of smooth recesses 16b may be provided on the side surface of the pressing sleeve 16 so that the patient can easily grasp the pressing sleeve 16 and the hand does not slip in the pressing direction.

[0027] (First adapter) The first adapter 13A is detachably arranged within the container body. In the present invention, one of the plurality of adapters that are replaceably arranged within the container body is called the first adapter for the purpose of identification, and the other adapters are called alternative adapters, but any adapter can be called the first adapter.

[0028] As shown in FIG. 5, the first adapter 13A is configured to detachably hold the cylinder of the self-injector at a predetermined holding position (A1) within the first adapter. Among these predetermined holding positions (A1), a particularly important element is the position predetermined in the longitudinal direction. In a preferred embodiment of the auxiliary tool, the finger flange of the cylinder is utilized to hold the cylinder of the self-injector at the predetermined holding position (A1) in the longitudinal direction.

[0029] As illustrated in FIG. 18(b), the self-injector has a cylinder 21, a plunger 25, and a needle (not shown) at the tip. The flange 22 of the cylinder is often provided with a finger flange (also called a finger grip) 22a so that it is easy for the patient to operate by hand. In a preferred embodiment of the auxiliary tool, as shown in FIG. 13, a recess for fitting the finger flange 22a is provided in the first adapter, and the self-injector is positioned on the first adapter by holding the finger flange 22a.

[0030] While holding the self-injector, the first adapter 13A moves to a plurality of engagement positions (Bx) within the container body. As a result, the self-injector also moves to the plurality of engagement positions (Bx). The first adapter 13A detachably engages with the container body at each of the plurality of engagement positions (Bx) within the container body. The structure for this engagement will be described later.

[0031] (Plural engagement positions (Bx)) The plurality of engagement positions (Bx) are located along the longitudinal direction and are at positions corresponding to different lengths (Lx) of the needle of the autoinjector. For example, if the length (Lx) of the needle is 13 mm, 16 mm, 19 mm, or 25 mm, the plurality of engagement positions (Bx) are four engagement positions (B1 to B4), and in order from the tip side to the rear end side, the first engagement position (B1) for 13 mm, the second engagement position (B2) for 16 mm, the third engagement position (B3) for 19 mm, and the fourth engagement position (B4) for 25 mm. For example, when using an autoinjector with a needle of length 13 mm, the first engagement position (B1) is selected. At this time, during use, the length of the needle protruding from the tip opening of the cover sleeve is 13 mm. Next, when using an autoinjector with a needle of length 16 mm, the first adapter is changed to the second engagement position (B2), and the autoinjector moves 3 mm longitudinally to the rear end side within the container body. By the autoinjector moving 3 mm to the rear end side, even for a needle of length 16 mm, the length of the needle protruding from the auxiliary tool during use is 13 mm. Thus, by selecting a predetermined appropriate engagement position (Bx) according to the length (Lx) of the needle, the length of the needle protruding from the tip opening of the cover sleeve during use becomes a constant length (C1).

[0032] (Alternative adapter) The alternative adapter 13B is an adapter disposed within the container body in place of the first adapter 13A. The action of the alternative adapter 13B itself within the container body is the same as the action of the above-described first adapter 13A. By selecting a predetermined appropriate engagement position (Bx) according to the length (Lx) of the needle, the length of the needle protruding from the tip opening of the cover sleeve during use becomes a constant length (C2). The important point here is that the protruding length (C2) of the needle is different from the length (C1) when using the first adapter 13A.

[0033] Also in the alternative adapter 13B, the cylinder of the autoinjector is removably held at a predetermined alternative holding position (A2). The configuration for holding the cylinder may be the same as that of the first adapter. As described above, it is preferable to provide a recess for fitting the finger flange 22a into the alternative adapter and position the autoinjector on the alternative adapter by holding the finger flange 22a.

[0034] (Holding position (A1) and alternative holding position (A2)) An important point of the alternative adapter 13B is that the alternative holding position (A2) for holding the cylinder of the autoinjector is different from the holding position (A1) in the first adapter. The alternative holding position (A2) is at a position longitudinally displaced by a predetermined amount (k) from the holding position (A1). This predetermined amount (k) is a value preset based on the puncture depth according to the patient. For example, when the recommended puncture depth for a patient with thicker subcutaneous fat is 13 mm, the first adapter 13A is used. On the other hand, when the recommended puncture depth for a patient with thinner subcutaneous fat than the above patient is 10 mm, the alternative adapter 13B is used. In that case, the alternative holding position (A2) of the alternative adapter 13B is a position displaced 3 mm toward the rear end side from the holding position (A1) of the first adapter 13A.

[0035] In the example shown in FIG. 1, the alternative adapter 13B is 3 mm longer than the first adapter 13A, and the autoinjector held by the alternative adapter 13B is held at a position displaced 3 mm toward the rear end side compared to the case of the first adapter 13A. Thus, even with the same 13 mm needle, when the first adapter is used, the puncture depth (the length the needle protrudes) is 13 mm, and when the alternative adapter is used, the puncture depth is 10 mm.

[0036] Also, even for an autoinjector with a needle of another length attached by a medical institution, when the first adapter is used, the puncture depth can always be adjusted to 13 mm, and when the alternative adapter is used, the puncture depth can always be adjusted to 10 mm.

[0037] A plurality of replacement adapters may be provided according to the types of the recommended puncture depths. For example, if there are three types of puncture depths such as 10 mm, 13 mm, and 16 mm, two types of replacement adapters can be provided accordingly. For example, a total of three types of puncture depths (10 mm, 13 mm, 16 mm) can be corresponded by a first adapter (puncture depth 10 mm) and two types of replacement adapters (puncture depths 13 mm and 16 mm).

[0038] FIG. 6 is a diagram clearly showing the difference in the actions of the first adapter 13A and the replacement adapter 13B. In FIG. 6(a), the length of the needle provided by the medical institution is L1, and the indicated puncture depth (the length of the needle protruding from the tip opening of the cover sleeve 10b) is C1. In FIG. 6(a), the first adapter 13A is used, and the first adapter 13A is located at the first engagement position (B1). In FIG. 6(b), the length of the needle provided by the medical institution is L2 (L1 < L2), and the indicated puncture depth is the same C1 as in FIG. 6(a). In FIG. 6(b), the first adapter 13A is used, but the first adapter 13A is located at the second engagement position (B2), and the auto-injector has moved to the rear end side. As a result, the puncture depth is adjusted to C1. In FIG. 6(c), the length of the needle provided by the medical institution is the same L1 as in FIG. 6(a), but the indicated puncture depth is C2 (C2 < C1). In FIG. 6(c), the replacement adapter 13B is used, and thus the cylinder 21 of the auto-injector is located more on the rear end side than in FIG. 6(a). Also, the replacement adapter 13B is located at the first engagement position (B1). As a result, the puncture depth is adjusted to C2. In FIG. 6(d), the length of the needle provided by the medical institution is L2 (L1 < L2), and the indicated puncture depth is the same C2 as in FIG. 6(c). In FIG. 6(d), the replacement adapter 13B is used, but the replacement adapter 13B is located at the second engagement position (B2), and the auto-injector has moved to the rear end side. As a result, the puncture depth is adjusted to C2.

[0039] (Configuration for changing the engagement position of the adapter) The configuration in which the first adapter and the alternative adapter are detachably engaged with the container body at each of the plurality of engagement positions (Bx) is not particularly limited, but a configuration in which a concave portion and a convex portion engage with each other is preferable because of its simple structure. As such a configuration, the following configurations (I) to (IV) are exemplified.

[0040] (I) As shown in FIG. 6, a plurality of concave portions having the same shape are provided on the inner surface of the container body according to the plurality of engagement positions (Bx), and one convex portion that fits into one of the plurality of concave portions is provided on the first adapter and the alternative adapter. This configuration is also shown in FIGS. 1, 4, 5, 9 to 13. When the plurality of concave portions are arranged in the longitudinal direction at equal pitch like the rack of a gear, the convex portions may also be arranged in the longitudinal direction at equal pitch like the rack of a gear. Further, the convex portion that fits into one concave portion may be divided into a plurality. Even if such a plurality of convex portions are added, it falls within the scope of the "configuration in which one convex portion that fits into one of the plurality of concave portions is provided".

[0041] (II) Contrary to the concave portion of (I) above, a plurality of convex portions having the same shape are provided on the inner surface of the container body according to the plurality of engagement positions (Bx), and one concave portion into which one of the plurality of convex portions fits is provided on the first adapter and the alternative adapter. Also in this case, when the plurality of convex portions are arranged in the longitudinal direction at equal pitch like the rack of a gear, the concave portions may also be arranged in the longitudinal direction at equal pitch like the rack of a gear. Further, a structure in which the convex portions and the concave portions are divided into a plurality may be adopted. Even if such a plurality of concave portions are additionally provided, it falls within the scope of the "configuration in which one concave portion into which one of the plurality of convex portions fits is provided".

[0042] (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 the inner surface of the container body is provided with one protrusion that fits into one of the plurality of recesses. In this case, as in (I) above, even if multiple convex portions are additionally provided on the inner surface of the container body, this falls under the "configuration in which one convex portion is provided that fits into one of multiple concave portions" referred to here.

[0043] (IV) Contrary to (III) above, the first adapter and the alternative adapter are provided with multiple convex portions of the same shape corresponding to the multiple engagement positions (Bx), and the inner surface of the container body is provided with one recess into which one of the multiple convex portions fits. In this case, as in (II) above, even if multiple recesses are added to the inner surface of the container body, this falls under the definition of "a configuration in which one recess is provided into which one of multiple protrusions fits."

[0044] (Through window showing needle length) In a preferred embodiment of the assisting device, as shown in FIG. 1, letters (or symbols) 101 indicating the length of the needle of the autoinjector are displayed on the inner surface of the container body 10 at positions corresponding to each of the plurality of engagement positions (Bx). In the example of FIG. 1, the lengths of the autoinjector needle (13, 16, 19, 25) are displayed at intervals according to the length. For example, the number "16" is positioned 3 mm further back than the number "13". These letters (or symbols) 101 may be printed directly on the container body, but a simpler and more preferred embodiment is to affix a sheet on which these letters (or symbols) 101 are printed to the inner surface of the container body, as shown in FIG. 1.

[0045] The character (or symbol) 101 is located in a position where it is covered and hidden by the first adaptor 13A and the alternative adaptor 13B when either the first adaptor 13A or the alternative adaptor 13B is attached to the container body. On one hand, the first adapter and the alternative adapter are each provided with one through-window 131, 132, and only the characters (or symbols) displayed at one display position can be seen through the through-windows 131, 132. When one of the first adapter 13A and the alternative adapter 13B engages with the container body at each of the plurality of engagement positions (Bx), only the characters (or symbols) indicating the length of the needle corresponding to the engagement position can be seen through the through-windows 131, 132, and the through-windows 131, 132 are positioned accordingly. For example, in the example of FIG. 1, when the needle length is 13 mm and the puncture depth is 13 mm, the first adapter 13A is positioned at one of the engagement positions (Bx). At this time, the through-window coincides with the position of "13" among the characters 101, and only "13" is visible to the patient. Also, when the needle length is 13 mm and the puncture depth is 10 mm, the alternative adapter 13B is positioned at one of the engagement positions (Bx). At this time, the through-window 132 coincides with the position of "13" among the characters 101, and only "13" is visible to the patient.

[0046] (Lock mechanism for preventing sliding) One or both of the container body and the pressing sleeve are provided with a lock mechanism for preventing the sliding of the pressing sleeve. With this lock mechanism, when the patient holds the pressing sleeve and presses the auxiliary tool against the skin during use, the force on the pressing sleeve is directly transmitted to the container body, and the cover sleeve on the tip side slides toward the rear end side to start the puncture of the needle. When the cover sleeve slides to the retreat limit, the puncture to a predetermined depth is completed.

[0047] The lock mechanism is provided with an unlocking button that enables the sliding of the pressing sleeve. When the patient operates the unlocking button in the state where the puncture is completed, the pressing sleeve becomes slidable, and the pressing sleeve moves toward the tip side by the patient's force to press the plunger and perform the injection of the chemical solution.

[0048] (Preferred embodiment of the lock mechanism) As a preferred embodiment of the above locking mechanism, there is an embodiment constituted by a cantilevered tongue portion provided on the outer surface of the container body and a notch portion provided at the front end portion of the pressing sleeve. The tongue portion may be provided anywhere on the outer surface of the container body, but an embodiment provided on the lid 11 as shown in FIG. 1 is more preferred.

[0049] As shown in FIG. 1, the shape of the notch portion 16a provided at the front end portion of the pressing sleeve 16 is tongue-shaped so that the tongue portion 11e can enter. The tongue portion 11e extends toward the rear end side along the longitudinal direction. When the lid is closed, as shown in FIG. 2, the tongue portion 11e enters into the notch portion 16a and prevents the pressing sleeve 16 from sliding toward the tip side.

[0050] The tip portion of the tongue portion 11e (the portion indicated as "PUSH" in FIG. 2(a)) is a portion that functions as an unlocking button. When the tip portion of the tongue portion 11e is pressed from the outside (i.e., when the patient presses it with a thumb or the like), the tongue portion 11e elastically deforms like a leaf spring, and the tip portion of the tongue portion 11e sinks into the container body 10. As a result, as shown in FIG. 3, the pressing sleeve 16 can slide to the tip side by passing over the outer surface of the tongue portion.

[0051] The configuration of pushing the unlocking button into the container body to release the lock is such that the direction of the force of the finger (especially the thumb) when gripping the auxiliary tool with one hand and the direction of the force of pushing the unlocking button are the same. Therefore, it is easy and preferable to perform the operation of pushing the unlocking button with the thumb or the like of one hand while gripping the pressing sleeve 16 of the auxiliary tool with one hand.

[0052] Hereinafter, a usage example of the auxiliary tool will be described with reference to the drawings. As shown in FIGS. 9 and 10, a convex portion 14 is provided on the lower side of the tip of the first adapter 13A, and it can be fitted into any of the concave portions 12a of the engaging portion 12 on the container body side. As shown in FIG. 9, engaging claws 15 (one engaging claw 15a and the other engaging claw 15b) are provided on the inner surface of the container body 10. When the convex portion 14 of the adapter 13 placed in the container body 10 is fitted into any of the concave portions 12a of the engaging portion 12, the engaging claws 15 engage with the first adapter 13A, and the first adapter 13A is fixed within the container body. The structure of the locking portion 15 is not particularly limited. For example, as shown in FIG. 9, 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 is exemplified.

[0053] As shown in FIG. 11, preferably, a doctor or a nurse in a medical institution opens the lid 11 and inserts the convex portion 14 of the first adapter 13A into any of the concave portions 12a of the engaging portion 12 of the container body 10. Then, as shown in FIG. 13, when the patient injects, the cylinder 21 and the finger flange 22 of the self-injector 20 are fixed to the first adapter 13A.

[0054] Here, as shown in FIGS. 11 and 12, by inserting the convex portion 14 of the first adapter 13A into any of the concave portions 12a of the engaging portion 12, it becomes possible to adjust the fixing position of the first adapter 13A along the longitudinal direction. By adjusting the position of the first adapter 13A, it is possible to fix the self-injector at an appropriate position within the container body 10 according to the length of the needle, and a constant puncture depth is always achieved. The same applies when using an alternative adapter instead of the first adapter 13A to achieve other puncture depths.

[0055] For example, when the needle is long, by inserting the convex portion 14 of the first adapter 13A into the concave portion 12a on the rear end side among the plurality of concave portions 12a of the engaging portion 12, the first adapter 13A is positioned on the rear end side, and the needle of the self-injector is also hidden near the opening of the cover sleeve. FIGS. 13 to 16 show the state where the needle 23 of the self-injector is covered by the cap 24.

[0056] On the other hand, if the needle is short, the convex portion 14 of the first adapter 13A can be inserted into the recess 12a on the tip side of the multiple recesses 12a of the engagement portion 12, so that the first adapter 13A is positioned on the tip side and the needle of the autoinjector is hidden near the opening of the cover sleeve.

[0057] Next, as shown in Figures 14 and 17(a), the patient closes cover 11, removes cap 24 from the needle of the autoinjector, and presses the tip of the assisting tool against the skin to puncture it (Figure 14 shows the needle 23 covered by cap 24). As shown in Figure 15, cover sleeve 10b receives a pressing force and moves to its retracted position, entering the container body, and the needle 23 of the autoinjector punctures the skin. Next, while pressing the unlock button at the tip of tongue portion 11e with their thumb, the patient pushes and slides pressing sleeve 16 toward the tip, as shown in Figures 16 and 17(b). This causes the plunger of the autoinjector to be pressed by the pressing head inside pressing sleeve 16, and the medicinal solution is injected subcutaneously.

[0058] The shapes of the container body 10 and the cover 11 are preferably such that the patient can easily insert the autoinjector and handle it. The cross-sectional shape of the pressing sleeve (the shape of a cross section perpendicular to the longitudinal direction) is preferably a shape that is easy to grip with one hand (particularly one hand), and is preferably an oval, ellipse, or circle as shown in Figures 8(e) and 8(f). The dimension of the major axis of the oval is not particularly limited, but is preferably, for example, about 56 mm to 50 mm. The dimension of the minor axis of the oval is not particularly limited, but is preferably, for example, about 34 mm to 30 mm. The normal overall length of the assisting tool is determined appropriately depending on the autoinjector, and is, for example, about 281 mm to 275 mm, and in the embodiment of Figure 1, it is about 278 mm.

[0059] 7 to 17, a window 11d is provided between the vicinity of the tip and the center of the cover 11. This allows the interior of the container body 10 to be viewed through window 11d, making it possible to check whether or not an autoinjector is inside the container body 10. Furthermore, as described above, making the entire lid 11 transparent makes it easier to check the presence and state of an autoinjector.

[0060] The configuration of the engaging portion 12 is not particularly limited. For example, as shown in FIGS. 5 and 6, convex portions having a rectangular or triangular cross-sectional shape are arranged at predetermined intervals along the longitudinal direction, and the spaces between these convex portions may be formed as concave portions 12a. The number of the concave portions 12a is not particularly limited.

[0061] The structures of the first adapter 13A and the alternative adapter 13B are not particularly limited, but preferably have a holding structure that prevents the cylinder of the self-injector from shifting in the longitudinal or lateral direction. For example, as shown in FIG. 9, a rectangular frame 13a for receiving and holding the body of the cylinder of the self-injector and a plate 13b forming a concave portion for receiving and holding the finger grip of the cylinder are preferably provided, and it may also have a shape like a long tray for holding the entire body of the cylinder.

Industrial Applicability

[0062] The present invention is useful as an auxiliary tool for a patient to perform self-injection using a self-injector such as a prefilled syringe preparation, and in particular, its usefulness becomes remarkable for self-injectors having different needle lengths by medical institutions.

[0063] The auxiliary tool has a first adapter and one or more alternative adapters that can be interchanged with each other, and each adapter is movable in the container body in the same manner. The positions of the self-injectors held by the respective adapters are different from each other and correspond to a plurality of different puncture depths by the patient, respectively. These features make it possible to solve the first problem that the needle lengths are different by medical institutions, and at the same time solve the second problem that the recommended values of the puncture depth may be different depending on the thickness of the patient's subcutaneous fat.

Explanation of Reference Numerals

[0064] 10 Container body 10b Cover sleeve 11 Lid 13A First adapter 13B Replacement adapter 16 Pressing sleeve

Claims

1. An auxiliary tool for a self-injector, the auxiliary tool comprising: A long container body having a longitudinal direction; The container body is configured to removably accommodate a self-injector along the longitudinal direction; The container body has a front end side corresponding to the needle side of the self-injector and a rear end side corresponding to the plunger side of the self-injector; A cover sleeve provided on the front end side of the container body; The cover sleeve is slidable between a forward limit and a rearward limit along the longitudinal direction; The cover sleeve is biased by a spring member to be positioned at the forward limit; When the cover sleeve is positioned at the forward limit, the needle of the self-injector is covered by the cover sleeve; When the auxiliary tool is pressed against the patient's skin during use, the cover sleeve moves to the rearward limit so that the needle of the self-injector protrudes from the tip opening of the cover sleeve; A pressing sleeve provided on the rear end side of the container body; The pressing sleeve is a portion for the patient to hold by hand and is slidable along the longitudinal direction by a predetermined moving distance of the plunger of the self-injector; The pressing sleeve has a pressing head inside, and when the pressing sleeve slides toward the front end side of the container body, the pressing head is configured to press the plunger head of the self-injector; A first adapter disposed within the container body; The first adapter is configured to removably hold the cylinder of the self-injector at a predetermined holding position (A1) within the first adapter; The first adapter is configured to removably engage with the container body at each of a plurality of engagement positions (Bx) within the container body; The plurality of engagement positions (Bx) are along the longitudinal direction and are at positions corresponding to different lengths (Lx) of the needle of the self-injector; By selecting the engagement position (Bx) according to the length (Lx) of the needle, the length of the needle protruding from the tip opening of the cover sleeve during the use becomes a constant length (C1); Having one or more alternative adapters disposed within the container body in place of the first adapter; The alternative adapter is configured to removably hold the cylinder of the self-injector at a predetermined alternative holding position (A2) within the alternative adapter; The replacement holding position (A2) is at a position that has moved a predetermined amount (k) in the longitudinal direction from the holding position (A1). The predetermined amount (k) is a value preset based on the puncture depth corresponding to the patient and is a different value for each replacement adapter. The replacement adapter is configured to be detachably engaged with the container body at each of the plurality of engagement positions (Bx). By selecting the engagement position (Bx) according to the length (Lx) of the needle, the length of the needle protruding from the tip opening of the cover sleeve during use becomes a constant length (C2), which is different from the constant length (C1).

2. The auxiliary tool according to claim 1, wherein the configuration in which the first adapter and the replacement adapter are detachably engaged with the container body at each of the plurality of engagement positions (Bx) is any one of the following configurations (I) to (IV): (I) A configuration in which a plurality of recesses having the same shape are provided on the inner surface of the container body according to the plurality of engagement positions (Bx), and one convex portion that fits into one of the plurality of recesses is provided on the first adapter and the replacement adapter; (II) A configuration in which a plurality of convex portions having the same shape are provided on the inner surface of the container body according to the plurality of engagement positions (Bx), and one recess into which one of the plurality of convex portions fits is provided on the first adapter and the replacement adapter; (III) A configuration in which a plurality of recesses having the same shape are provided on the first adapter and the replacement adapter according to the plurality of engagement positions (Bx), and one convex portion that fits into one of the plurality of recesses is provided on the inner surface of the container body; (IV) A configuration in which a plurality of convex portions having the same shape are provided on the first adapter and the replacement adapter according to the plurality of engagement positions (Bx), and one recess into which one of the plurality of convex portions fits is provided on the inner surface of the container body.

3. The auxiliary tool according to claim 1 or 2, wherein characters or symbols indicating the length of the needle of the self-injector are displayed at display positions corresponding to each of the plurality of engagement positions (Bx) on the inner surface of the container body, the characters or symbols are in positions covered and hidden by the first adapter and the replacement adapter, and one through window is provided in the first adapter and the replacement adapter, and only the characters or symbols displayed at one display position can be seen through the through window, and 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 symbol indicating the length of the needle corresponding to the engagement position is visible through the through-window, and the through-window is positioned accordingly.

4. An auxiliary tool according to any one of Claims 1 to 3, wherein one or both of the container body and the pressing sleeve are provided with a locking mechanism that prevents the sliding of the pressing sleeve, and the locking mechanism is provided with an unlocking button that enables the sliding of the pressing sleeve.

5. An auxiliary tool according to Claim 4, wherein the locking mechanism is constituted by a cantilevered tongue portion provided on the outer surface of the container body and a notch portion provided at the front end portion of the pressing sleeve, the shape of the notch portion is tongue-shaped so that the tongue portion can enter, the tongue portion extends toward the rear end side along the longitudinal direction, enters the notch portion, and prevents the pressing sleeve from sliding toward the front end side, the tip portion of the tongue portion is a portion that functions as an unlocking button, and when the tip portion of the tongue portion is pressed from the outside, the tongue portion elastically deforms as a cantilever beam, and the tip portion of the tongue portion sinks into the container body, whereby the pressing sleeve can pass over the tip portion of the tongue portion and slide toward the front end side.

6. An auxiliary tool 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 for closing the opening, the cantilevered tongue portion in the locking mechanism extends longitudinally from the rear end surface of the lid, enters the notch portion of the pressing sleeve, and prevents the pressing sleeve from sliding toward the front end side.

7. An auxiliary tool according to any one of Claims 1 to 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 for closing the opening.

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