HOUSING

Abstract

A housing (1) according to the present invention comprises a slide (20) configured to detachably secure an injector (40) having one, two, or more injection needles (44) having a protrusion height greater than 0 µm and less than or equal to 5,000 µm, and an assembly (30) comprising the slide (20) disposed within it and supporting the slide (20) so as to allow it to be advanced and retracted in a direction. The assembly (30) is configured to advance the slide (20) by means of a pushing force and / or a drive mechanism to a location where the injection needle(s) (44) pierce(s) the skin.The slide (20) and the assembly (30) each have a lateral opening (23, 33) extending in the direction of the slide's advance / retraction, and the injector (40) is configured so that it can be mounted on the slide (20) from one side of the assembly (30) through the lateral openings (23, 33). Abbreviated figure: Figure 1.

Description

Title of the invention: CASE technical field

[0001] The present invention relates to a housing. PREVIOUS ART

[0002] In recent years, the intradermal administration of a liquid, such as a medication, using a protruding tool with a fine injection needle, called a microneedle or similar device, has attracted attention in the medical, cosmetic, and related fields. With this protruding tool, it is possible to inject a liquid into the body by inserting the microneedle into a relatively shallow layer of the skin, such as the stratum corneum, which significantly reduces the pain experienced by the subject compared to that experienced with a standard injection needle. Consequently, the protruding tool has garnered attention as a minimally invasive means of liquid administration.

[0003] A technique for piercing the skin with a microneedle using a housing that moves the microneedle towards the skin is known. For example, patent document 1 describes a microneedle housing comprising an outer sleeve, an inner sleeve movably mounted inside the outer sleeve, and a microneedle unit movably mounted inside the inner sleeve and comprising a microneedle array having microneedles at one distal end. When the inner sleeve moves in a direction opposite to a protrusion direction, the microneedle unit is configured to move in the protrusion direction.

[0004] Patent document 2 describes an actuation tool for a fluid injector using a microneedle device comprising an external cylinder having a receiving space which movably retains an injector and a mechanism which moves the injector into the receiving space.

[0005] LIST OF CITATIONS

[0006] Patent literature

[0007] Patent document 1: JP 2019-97656 A

[0008] Patent document 2: WO 2014 / 2872 Summary of the invention Technical problem

[0009] When a liquid such as a drug is administered intradermally via a microneedle, it is known to use a device facilitating the puncture to make the procedure easier. Furthermore, it is desirable that a device facilitating the puncture used with an injector attached to it can be reused by replacing only the injector.

[0010] However, in the puncture device described in patent document 1, the microneedle unit containing the microneedles is arranged inside two helical springs, namely the first and second helical springs. This makes it difficult to reuse the puncture device by replacing only the microneedle unit. Moreover, it is highly likely that a microneedle will come into contact with the puncture device during replacement. When a microneedle is damaged by such contact, it may be rendered unusable or the effect of the injection may be reduced. Furthermore, when a liquid agent adheres to the puncture device as a result of such contact, the puncture device cannot be reused unless it is sterilized.

[0011] The actuation tool for a fluid injector described in patent document 2 includes a mechanism for manually moving the injector, and therefore cannot prevent the occurrence of individual differences in puncture conditions.

[0012] The present invention relates to a housing suitable for eliminating contact between an injection needle and the housing and suitable for preventing the occurrence of individual differences in puncture conditions. SOLUTION TO THE PROBLEM

[0013] The present invention relates to a housing for facilitating puncture with one or two or more of two injection needles of an injector, said one or two or more of two injection needles having a protrusion height greater than 0 pm and less than or equal to 5,000 pm.

[0014] In one embodiment, the housing comprises a slider and an assembly.

[0015] In one embodiment, the slider can be detachably fixed the injector and can be placed inside the assembly.

[0016] In one embodiment, the assembly can support the slider.

[0017] In one embodiment, the slider is configured to advance and retract into one direction, and the housing is configured to advance the injector and slide by means of a thrust force and / or a drive mechanism to an advanced location where said one or two or more of two injection needles pierce the skin.

[0018] In one embodiment, the slide and the assembly each have a lateral opening extending in a direction of advancement / retraction of the slide.

[0019] In one embodiment, the housing is configured such that the injector can be mounted on the slide from one side of the assembly through the side opening of the slide and the side opening of the assembly.

[0020] The present invention relates to a kit comprising the case described above and the injector containing a drug solution and individually packaged.

[0021] The present invention relates to a puncture method for puncturing with an injection needle from an injector using a housing.

[0022] In one embodiment, the protrusion height of the injection needle is greater than 0 pm and less than or equal to 5,000 pm.

[0023] In one embodiment, the housing comprises a slider and an assembly.

[0024] In one embodiment, the slider is arranged inside the assembly.

[0025] In one embodiment, the assembly can support the slider so as to to be able to move it forward and get it going in a certain direction.

[0026] In one embodiment, the slide and the assembly each have a lateral opening extending in a direction of advancement / retraction of the slide.

[0027] In one embodiment, the puncture method comprises mounting the injector on the slide from one side of the assembly through the lateral openings.

[0028] In one embodiment, the puncture method comprises advancing the injector and the slider towards the skin by means of a pushing force and / or a drive mechanism (preferably at a speed of 1,000 mm / s to 7,000 mm / s).

[0029] The present invention relates to an injection method comprising performing the puncture using the puncture method described above, and then performing an injection operation.

[0030] In one embodiment, the injector comprises said one or two or more of two injection needles and a liquid agent container coupled to the injection needles so as to allow liquid to pass through it.

[0031] In one embodiment, the liquid agent container is an injection device comprising a syringe cylinder and a piston.

[0032] In one embodiment, one or two or more than two pressing protrusions are provided on an external surface of the assembly.

[0033] In one embodiment, the puncture is carried out by the puncture process described above, and the injection operation is carried out by pressing the piston while holding a finger on one of said one or two or more of two pressing protrusions.

[0034] The present invention relates to an injection method comprising performing the puncture using one or two or more of two injection needles of an injector by the puncture method described herein, and injecting one or two or more of two selected injections from a vaccine intended to prevent an infectious disease, a vaccine intended to treat an infectious disease, an analgesic (e.g., an analgesic for cancer patients), insulin, a biological product, a polynucleotide-based drug (such as a gene therapy drug), and similar through the injection needle.

[0035] In one embodiment, the vaccine intended to prevent an infectious disease preferably comprises a vaccine intended to prevent one or two or more of two diseases selected from hepatitis A, hepatitis B, hepatitis C, influenza, COVID-19, tuberculosis, rabies, polio, chickenpox, rubella, measles, tetanus, and / or shingles, or similar.

[0036] In one embodiment, the vaccine intended to treat an infectious disease preferably comprises a vaccine intended to treat one or two or more of two diseases selected from hepatitis B (such as chronic hepatitis B), tuberculosis, rabies, a malignant neoplasm, and / or shingles, or similar. Brief description of the drawings

[0037] Illustrative examples of the present invention are shown in the figures, in which:

[0038] Fig. 1 is a perspective view of a housing according to a preferred embodiment of the present invention and of an injector mounted on the housing;

[0039] [Fig.2] is a perspective view illustrating an injector before it is mounted on the housing illustrated in [Fig.1];

[0040] [Fig. 3] is a perspective view illustrating the injector shown in [Fig. 2] in a state in which it is not coupled to a tool with protrusions;

[0041] [Fig.4] is a schematic enlarged cross-sectional view illustrating an example of a tool with protrusions equipped with injection needles;

[0042] Figs. 5(a) to (c) are schematic enlarged cross-sectional views of protrusions included in the protrusion tool illustrated in Fig. 4; Fig. 5(a) is a schematic enlarged cross-sectional view of the injection needle; Fig. 5(b) is a schematic enlarged cross-sectional view of a first protrusion; Fig. 5(c) is a schematic enlarged cross-sectional view of a second protrusion;

[0043] [Fig. 6] is a perspective view illustrating an assembly of the housing shown in the [Fig.l] in an advanced sliding state;

[0044] [Fig.7] is a perspective view illustrating the entire housing shown in [Fig.6] in a retracted slide state;

[0045] [Fig. 8] is a cross-sectional view considered along line CC of the [Fig.6];

[0046] [Fig.9] is a cross-sectional view considered along line DD of [Fig.6];

[0047] [Fig. 10] is an explanatory view of a state locked by a locking mechanism;

[0048] [Fig.1 1] is a perspective view illustrating the retracted slide state of the housing illustrated in [Fig.1];

[0049] [Fig. 12] is a view illustrating a state in which the skin is pierced with the injection needles using the housing illustrated in [Fig. 1], and is a cross-sectional view schematically illustrating a cross-section in the direction of the thickness of the skin;

[0050] [Fig. 13] is a cross-sectional view considered along line EE of [Fig. 7]. DETAILED DESCRIPTION

[0051] In what follows, the present invention will be described with reference to the drawings based on preferred embodiments. It should be noted that, in the following description of the drawings, identical or similar parts are designated by the same or similar reference numerals. The drawings are essentially schematic, and the dimensional and similar ratios may differ from the actual ratios.

[0052] Fig. 1 illustrates a housing 1 according to a preferred embodiment of the present invention and an injector 40 mounted on the housing 1. Figs. 6 and 7 illustrate the housing 1 in a state in which the injector 40 is not mounted.

[0053] The housing 1 of the present invention is a device facilitating puncture to facilitate puncture by an injection needle 44.

[0054] The housing 1 of the present invention preferably comprises a slide 20 and an assembly 30.

[0055] The slide 20 is preferably adapted to removably fix the injector 40. Generally, the injector 40 must be arranged inside the slide 20.

[0056] The slide 20 is preferably arranged inside the assembly 30.

[0057] The assembly 30 preferably supports the slide 20 so that it can be advanced and retracted in a direction X. Generally, the slide 20 and the injector 40 are arranged inside the assembly 30 so that they can be advanced and retracted in said direction X. Said direction X in which the slide 20 advances and retracts is also simply designated as the advance / retraction direction X of the slide. Furthermore, a direction equivalent to the advance / retraction direction X of the slide within the assembly 30 is also called the axial direction X of the assembly.

[0058] The injector 40 comprises an injection needle 44 and a liquid agent container 50 coupled to the injection needle 44 in such a way as to allow liquid to pass through it. The injection needle 44 and the liquid agent container 50 are coupled in a detachable or non-detachable manner.

[0059] The injector 40 preferably includes a needle base 47 between the injection needle 44 and the liquid agent container 50. The needle base 47 generally supports the injection needle 44 directly or indirectly. An outer surface of the needle base 47 is generally a locking Luer tip.

[0060] A specific example of the injector 40 in which the injection needle 44 and the liquid agent container 50 are coupled is illustrated in [Fig.2].

[0061] The liquid agent container 50 is generally an injection device 51 comprising a syringe cylinder 51a and a piston 58.

[0062] The injection device 51 generally includes a receiving section 52 adapted to contain a liquid agent L within it. The syringe cylinder 51a preferably includes, at an end portion in a longitudinal direction thereof, a liquid injection orifice 53 for supplying the injection needle 44 with liquid agent L, and a connection section 54 to the needle base 47 supporting the injection needle 44.

[0063] The injection device 51 generally comprises the syringe cylinder 51a having a cylindrical shape. The syringe cylinder 51a preferably comprises, at one end portion in the longitudinal direction, a distal end portion 51b comprising the connecting section 54. The syringe cylinder 51a preferably comprises, at the other end portion in the longitudinal direction, a collar-forming portion 56.

[0064] The liquid injection orifice 53 is generally located at the distal end portion 51b. Generally, the liquid injection orifice 53 has a cylindrical shape having a diameter smaller than that of a portion of the syringe cylinder 51a having, inside it, the receiving section 52, and its distal end is open.

[0065] The connecting section 54 preferably comprises a female threaded edge 54a on an inner circumferential surface. The threaded edge 54a can preferably be screwed onto a projecting portion 49 of the needle base 47 described above.

[0066] The syringe cylinder 5la is made, for example, of glass or a synthetic resin, but is not limited to these.

[0067] The piston 58 generally includes an actuating rod 59 and a sealing ring 59a.

[0068] The sealing ring 59a is generally provided at a distal end of the actuating rod 59 and is disposed inside the syringe cylinder 51a. The sealing ring 59a can preferably be pressed into the inside of the syringe cylinder 51a.

[0069] The actuating rod 59 is preferably provided, at a rear end thereof, with a pressing actuating part 59b which is pressed by a finger during an injection operation of the liquid agent L. The actuating rod 59 is preferably made of a synthetic resin material and formed into a rod shape.

[0070] The sealing ring 59a is generally formed from an elastic material, such as a synthetic rubber, in a cylindrical shape having a distal end having a triangular pyramidal shape and can slide on an inner circumferential surface of the syringe cylinder 51a. By means of the sealing ring 59a, the receiving section 52 filled with the liquid agent L is formed inside the syringe cylinder 51a. In a state in which the liquid agent L is contained in the receiving section 52, the sealing ring 59a is pushed towards the side of the distal end portion 51b of the syringe cylinder 51a jointly with the actuating rod 59, whereby the liquid agent L is supplied to the injection needle 44 from the liquid injection port 53 provided in the distal end portion 51b.

[0071] The injector 40 used in the present invention preferably comprises a tool with protrusions 41 including the injection needle 44 and the needle base 47 which supports the injection needle 44. An example of this is illustrated in [Fig.4].

[0072] The injection needle 44 has an opening 44a through which liquid can be ejected.

[0073] The injection needle 44 preferably has a hollow interior.

[0074] The injection needle 44 preferably has a conical shape and comprises the opening 44a. The injection needle 44 preferably has the opening 44a at a portion of its distal end. The distal end portion of the injection needle 44 designates a region on one side of the distal end of an intermediate location with a projecting height H1 of a proximal surface 43 at a distal end of the injection needle 44 (see [Fig. 5](a)).

[0075] The opening 44a can be formed in the distal end or can be formed in a lateral surface of the injection needle 44. A hollow portion 44b of the injection needle 44 and the exterior communicate through the opening 44a. That is to say, the opening 44a is a penetrating hole that penetrates through the injection needle 44 in the thickness direction.

[0076] The injection needle 44, with a view to minimal invasiveness during puncture, has a projecting height from the proximal surface 43 from which the protrusion protrudes which is preferably less than or equal to 5,000 sqm, more preferably less than or equal to 3,000 sqm.

[0077] With a view to improving puncture performance, the protruding height of the injection needle 44 is preferably greater than 0 qm, more preferably greater than or equal to 500 qm, and even more preferably greater than or equal to 1000 qm.

[0078] Such an injection needle 44 is applicable not only to treatment but also to personal care, body care, or the like.

[0079] The injector 40 may include a first protrusion 45 and / or a second protrusion 46 in addition to the injection needle 44. For example, the injector 40 may include the first protrusion 45 and / or the second protrusion 46 in addition to the injection needle 44 in the protrusion tool 41 coupled to the liquid agent container 50. An example of such an injector is illustrated in [Fig.4] or [Fig.5].

[0080] The first protrusion 45 is preferably a protrusion without openings. The first protrusion 45 preferably has a conical shape. The conical shape of the first protrusion 45 may be a substantially circular conical shape or a substantially polygonal pyramidal shape.

[0081] A projection height H2 of the first protrusion 45 is preferably equal to the projection height H1 of the injection needle 44 or less than the projection height H1 of the injection needle 44. The first protrusion 45 generally has the same projection height as that of the injection needle 44 and has a projection height greater than that of the second protrusion 46.

[0082] The second protrusion 46 is preferably a protrusion without openings. A distal end surface of the second protrusion 46 is preferably substantially flat, i.e., not conical. The second protrusion 46 generally has a projecting height less than that of the injection needle 44 and the first protrusion 45.

[0083] The distal end surface of the second protrusion 46 may have a linear shape extending in a horizontal direction, or it may be a curved line projecting outward from the second protrusion 46. The second protrusion 46 preferably has a columnar shape. The columnar shape of the second protrusion 46 may be substantially circular or substantially polygonal, such as a quadrangular shape.

[0084] In the present invention, when the injection needle 44 is inserted into the skin, the first protrusion 45 is preferably also inserted into the skin. With the first protrusion 45 inserted into the skin, it is possible to prevent traction on the skin and thus improve puncture capability. Furthermore, with the first protrusion 45 inserted into the skin, it is possible to bring the first The protrusion 45 stimulates the skin and promotes blood circulation, thereby stimulating an immune-inducing effect. Consequently, thanks to the injector 40 incorporating the first protrusion 45, the liquid can be easily injected into the skin via the injection needle 44, and blood circulation and the immune-inducing effect can be stimulated by the first protrusion 45.

[0085] The presence or absence of a blood circulation stimulation effect can be determined by various known methods such as, for example, by determining whether a rash reaction occurs in the skin or by visualizing the distribution of blood circulation using a laser blood flowmeter.

[0086] In the present invention, when the injection needle 44 and the optional first protrusion 45 are inserted into the skin from the distal end, preferably the distal end surface of the second protrusion 46 comes into contact with a skin surface. This stops the insertion of the injection needle 44 and the optional first protrusion 45 and prevents the injection needle 44 and the first protrusion 45 from being inserted into a deeper area of ​​the skin. That is to say, the distal end surface of the second protrusion 46 acts as a stop that limits the insertion depths of the injection needle 44 and the first protrusion 45, thereby controlling the insertion depths in the skin.

[0087] With a view to considerably reducing pain associated with transdermal absorption or reliable injection of the liquid agent into the skin from the injection needle 44, a height difference between a distal end location of the injection needle 44 and a location on the distal end surface 46a of the second protrusion 46 is preferably from 1 pm to 5,000 pm, more preferably from 5 pm to 4,000 pm. The height difference is a difference H1 - H3 between the protrusion height H1 of the injection needle 44 (see [Fig. 5](a)) and a distance H3 from the proximal surface 43 from which the second protrusion 46 protrudes to the distal end surface 46a (see [Fig. 5](c)).

[0088] With a view to a considerable reduction of the pain associated with the effect of stimulating blood circulation by means of the first protrusion 45, of a suppression of the failure of puncture of the injection needle 44 caused by the resistance of the skin, and of a sufficient insertion of the injection needle 44 into the skin, the protrusion height H2 of the first protrusion 45 (cf. [Fig.5](b)) is preferably greater than or equal to the distance H3 from the proximal surface 43 from which the second protrusion 46 protrudes to the distal end surface 46a, i.e. H2 > H3, more preferably H2 > H3.

[0089] In this same perspective and in order not to damage the skin more than necessary, the difference H2 - H3 is preferably from 0 pm to 5,000 pm, more preferably from 100 pm to 5,000 pm, and even more preferably from 400 pm to 4,000 pm.

[0090] In order to more reliably obtain the blood circulation stimulation effect, to ensure reliable puncture with the injection needle 44, and to eliminate leakage of liquid agent caused by insufficient insertion, the injection needle 44 is preferably higher than the first protrusion 45. More specifically, the difference H1 - H2 between the protrusion height H1 of the injection needle 44 and the protrusion height H2 of the first protrusion 45 is preferably, in order to easily obtain both the ease of liquid injection and the blood circulation stimulation effect, from 1 pm to 5,000 pm, more preferably from 5 pm to 4,000 pm.

[0091] The projecting height H1 of the injection needle 44 is preferably, with a view to eliminating the obstacle to insertion caused by the deformation of the skin when the injection needle 44 is pressed against the skin, to improve the puncture capacity, and to reliably inject the liquid agent into the skin S, and with a view to low invasiveness, from 10 pm to 5,000 pm, more preferably from 20 pm to 4,000 pm.

[0092] The projection height H2 of the first protrusion 45 is preferably, in order to stimulate the skin by being pressed against the skin to promote blood circulation and in order to minimize invasiveness, from 10 pm to 5,000 pm, more preferably from 20 pm to 4,000 pm. The projection height H3 of the second protrusion 46 is preferably from 5 pm to 4,000 pm, more preferably from 10 pm to 3,000 pm. The projection height H3 of the second protrusion 46 is the distance H3 from the proximal surface 43 from which the second protrusion 46 protrudes to the distal end surface 46a.

[0093] The needle base 47 preferably comprises a base assembly 47a having a tubular shape overall. The base assembly 47a preferably comprises a hollow portion 47b defined within the needle base 47. Openings are generally formed on both sides of the hollow portion 47b in an axial direction of the base assembly 47a, and the hollow portion 47b and the exterior communicate through these openings. One of the openings functions, for example, as a supply port when a liquid agent is supplied to the hollow portion 47b using the injection device 51. The other opening functions, for example, as a supply port when the liquid agent supplied from the injection device 51 is supplied to the injection needle 44.The needle base 47 preferably comprises a large diameter portion 47c located on a side close to the injection needle 44 and a small diameter portion 47d located on a side far from the injection needle. 44 and having an outer diameter smaller than that of the large diameter portion 47c. The needle base 47 may comprise the base assembly 47a and a protruding sheet 42 having protrusions such as the injection needle 44. The protruding sheet 42 preferably comprises protrusions such as the injection needle 44 and a base portion having a leaf-like shape.

[0094] The slide 20 generally has a long shape extending in the advance / retraction direction X, and a length in the axial direction X longer than a length in the width direction Y orthogonal to the axial direction.

[0095] Furthermore, the slide 20 preferably has a shape with a circular arc cross-section in which a portion of a circumferential wall of the cylinder in the circumferential direction is continuously removed in the axial direction of the cylinder. Then, the missing portion of the cylinder preferably forms a lateral opening 23 extending in the forward / retract direction X of the slide 20.

[0096] The slide 20 preferably includes a receiving section 21 for a liquid agent container. More specifically, the slide 20 preferably has a side wall portion 28 defining the receiving section 21 for the liquid agent container. The receiving section 21 for the liquid agent container generally receives the injection device 51, which is the liquid agent container 50.

[0097] A fixing protuberance 22 which narrows a portion of the needle base 47 of the injector 40 is preferably provided on the skin side of the receiving section 21 of the liquid agent container.

[0098] The receiving section 21 of the liquid agent container preferably has a length in the circumferential direction of the injector 40 that is less than or equal to half the circumference of the injector 40 in order to facilitate the mounting of the injector 40.

[0099] The attachment protrusion 22 preferably has a circular arc shape in a cross-section orthogonal to said direction. A radius of curvature of the attachment protrusion 22 is preferably smaller than that of the receiving section 21 of the liquid agent container. The attachment protrusion 22 preferably includes a pair of gripping protrusions 22a at its two end portions in the circumferential direction. A length of the attachment protrusion 22 in the circumferential direction of the injector 40, including that of the pair of gripping protrusions 22a, is preferably longer than half the circumference of the constricted portion of the injector 40.

[0100] The injector 40 preferably comprises a narrowed portion 48 between the large diameter portion 47c of the needle base 47 and the distal end portion 51b of the device injection 51. This narrowed portion 48 preferably serves as an entry groove that mechanically engages with the fixation protrusion 22 and / or the pair of gripping protrusions 22a. This narrowed portion 48 has a smaller outer diameter than the outer shapes of the large-diameter portion 47c and the distal end portion 51b. The narrowed portion 48 is preferably a narrowed portion that is narrowed by the fixation protrusion 22. In this case, the narrowed portion is narrowed by the fixation protrusion 22 simply by pushing the narrowed portion 48 of the protruding tool 41 into the fixation protrusion 22 from the side where the lateral opening 23 is open. Thus, rattling is less likely to occur between the protruding tool 41 and the fixation protrusion 22.The inlet groove with which the retaining protrusion 22 and / or the pair of gripping protrusions 22a engage is also referred to as the narrowing inlet groove. The narrowing inlet groove is preferably located between the injection needle 44 and the liquid agent container 50, such as the injection device 51. The narrowing inlet groove is, for example, the narrowed portion 48 formed by connecting a male and female fitting of a small-diameter fitting for liquids and gases (ISO 80369-7:2021) around the female fitting, but it can be formed by another method. For example, a groove can be formed in an annular shape around the large-diameter portion 47c, and this groove can be used as the inlet groove.

[0101] The male and female connectors, where the needle base 47 and the liquid agent container 50, such as the injection device 51, are connected by a Luer fitting, are preferably locking Luer fittings. The locking Luer fitting does not unlock easily, and therefore the state of the injector 40, which is held by the slide 20, is not easily released, making the locking Luer fitting preferable. The inlet groove for the narrowing socket is not limited to a groove with a length corresponding to the entire circumference of the injector 40, and may be a groove not having a length corresponding to the entire circumference of the injector 40, such as, for example, a groove with a length corresponding to half the circumference.

[0102] The fixation protrusion 22 preferably engages with an engagement groove located between the injection needle 44 and the liquid agent container 50, such as, for example, the constricted portion 48 described above. When the fixation protrusion 22 is provided, a portion located near the skin is constricted when the skin is pierced. Consequently, even if the injector 40 is slightly inclined inside the slide 20, the effects of this are less likely to occur. Individual differences are therefore less likely to occur. under puncture conditions such as a puncture angle. In addition, the injector 40 which uses, as injection device 51, a different syringe 51 having a small outside diameter can also be used.

[0103] The slide 20 preferably includes a rear attachment portion 24 fitted around the injector 40 on one side opposite the skin of the liquid agent container receiving section 21. The rear attachment portion 24 preferably has a circular arc-shaped cross-section with a smaller radius of curvature than that of the liquid agent container receiving section 21, and includes a pair of gripping protrusions 24a at its two end portions in the circumferential direction. A length of the rear attachment portion 24 in the circumferential direction of the injector 40, including that of the pair of gripping protrusions 24a, is preferably longer than half the circumference of the syringe cylinder 51a serving as the tapered portion of the injector 40.This allows a part of the injector 40 to be fixed so that a rattling does not occur between this part and the rear fixing part 24 simply by pushing this part into the rear fixing part 24 from the side where the lateral opening 23 is open.

[0104] The assembly 30 preferably comprises an internal space and a portion 31 surrounding the internal space. The internal space receives the slide 20. The portion 31 surrounding the internal space encloses a periphery of the internal space, with the exception of a portion serving as a lateral opening 33 in a cross-section orthogonal to the forward / retract direction X of the slide. The portion 31 surrounding the internal space comprises an inner wall 34 facing the internal space and an outer wall 35 forming an exterior surface of the assembly 30. Furthermore, the lateral opening 23 of the slide 20 and the lateral opening 33 of the assembly 30 generally open in the same direction in a cross-section orthogonal to the forward / retract direction X of the slide 20.Furthermore, the two sides of the lateral opening 33 in the assembly 30 are generally mating walls connecting the inner wall 34 and the outer wall 35, and a space between the mating walls is the lateral opening 33. The lateral openings 23, 33 are preferably wide enough to allow the injector 40 to pass through them. In a cross-section of the assembly 30 orthogonal to the forward / retract direction X of the slide 20, a side including the lateral opening 33 is also called the front side, and a side not including the lateral opening 33 is also called the rear side.

[0105] According to the housing 1 of the present invention, generally, the injector 40 can be mounted on the slide 20 from one side of the assembly 30 through the lateral opening 23 of the slide 20 and the lateral opening 33 of the assembly 30, which facilitates the operation of mounting the injector 40.

[0106] This reduces the possibility of the injection needle 44 and the housing 1 coming into contact with each other when the injector 40 is attached to the slide 20 or removed after injection. This prevents the injection needle 44 from being damaged, damage which renders the injector 40 or the protrusion tool 41 unusable and reduces injection efficiency.

[0107] Furthermore, when the injector 40 is attached to the slide 20, it is not necessary to remove the protruding tool 41 from the injection device 51. This allows the protruding tool 41 to be attached to the slide after it has been attached to the injection device 51, thus optimizing the amount of medication received in the receiving section 52.

[0108] Even when the injector 40 is removed from the slide 20 after injection, it is not necessary to remove the protruding tool 41 from the injection device 51. This also reduces the possibility of the liquid agent emitted from the injector 40 adhering to the housing 1. Therefore, after the injector 40 has been mounted on the housing 1 and the injection operation has been carried out, the housing 1 can be reused repeatedly by replacing only the injector 40.

[0109] The casing of the present invention can be discarded after a single injection or can be used repeatedly.

[0110] The housing 1 preferably comprises a slide that limits the forward / retract direction X of the slide 20 to said direction X. The slide preferably comprises a groove 39 formed in the inner wall 34 of the part 31 surrounding the internal space and a guide protrusion 21a provided on the slide 20 (see [Fig. 13]). Provided that the guide protrusion 21a is mechanically engaged with the groove 39 (formed in the inner wall 34) and can slide in said direction X, it is preferable that the guide protrusion 21a constitutes or serves as the slide. It should be noted that [Fig. 13] partially omits the internal structure of the housing 1 for the sake of clarity.

[0111] The groove 39 generally has an opening shape extending in the forward / retract direction X of the slide 20. When the guide protrusion 21a inserted in the groove 39 moves along the groove 39, the forward / retract direction X of the slide 20 is limited to said specific direction X.

[0112] The guide protuberance 21a is provided, for example, at both ends, with a cylindrical wall portion having a cross-section in the form of a circular arc in the receiving section 21 of the liquid agent container of the slide 20 so as to protrude outwards in the width direction Y. Two or more guide protuberances 21a may be provided at an interval in the longitudinal direction of the slide 20.

[0113] In order to limit more precisely the direction of advance / retraction of the slide 20, the space between the groove 39 and the guide protuberance 21a is preferably, in a state of engagement of the latter, greater than 0 mm and less than or equal to 1 mm.

[0114] In this same perspective, each of the groove 39 and the guide protuberance 21a constituting the slide is preferably provided at two or more of two locations in the circumferential direction of the housing 1.

[0115] The slide can be formed by providing the guide protrusion 21a on the inner wall 34 of the part 31 surrounding the internal space and by providing the groove 39 in which the guide protrusion 21a is inserted into the slide 20.

[0116] By means of the slide, deviation of the slider 20 during puncture and / or drug injection is eliminated. This facilitates maintaining the correct angle of inclination and similar position of the injection needle 44 relative to the skin during puncture and / or drug injection.

[0117] The assembly 30 of the housing 1 preferably comprises two helical springs 61 pushing the slide 20 in the forward direction A. The helical spring 61 is generally arranged in a slightly compressed state between a rear wall 36 of the assembly 30 and a spring receiving portion 25. The spring receiving portion 25 is formed in the slide 20 so as to project outwards from the side wall portion 28. An advanced position of the slide 20 is generally an advanced position which is advanced by a repulsive force of the helical springs 61 until it abuts against a front limiting portion 62 provided on the assembly 30. An example of this is illustrated in [Fig. 8].

[0118] The assembly 30 preferably comprises a retention mechanism (a retention device) and a retention release mechanism (a retention release device). The retention device retains the slide 20 at a retracted position that is retracted in a direction opposite to the skin relative to the advanced position. The retention release device releases the retention of the device and advances the slide to the advanced position. The advanced position is a position at which the injection needle pierces the skin. Furthermore, the direction opposite to the skin is a direction away from the skin and is generally the same direction as a retraction direction B.

[0119] The retaining device includes, for example, a retaining protrusion 64 projecting from the slide 20 and a retaining support 65 provided on the assembly 30. Then, when the slide 20 is retracted from a predetermined location against the repulsive force of the helical springs 61, the retaining protrusion 64 and the retaining support 65 are configured to engage with each other.

[0120] Specifically, the retaining protuberance 64 is preferably provided on a rear surface of the slide 20.

[0121] In addition, the inner wall 34 of the assembly 30 is preferably provided with a guide hole 34a extending in the axial direction X of the assembly 30 and allowing the inserted retaining protrusion 64 to move in the forward / retract direction X. An example of this is illustrated in [Fig.9] and 10.

[0122] The restraint release device preferably comprises a release member 68 having a rod-like shape and physically interlocked with a skin pressure element 71 described below. When the skin pressure element 71 is pressed against the skin, the release member 68 presses a portion of the restraint support 65 in a mechanically interlocked manner. Consequently, the engagement state between the restraint protrusion 64 and the restraint support 65 is preferably configured to be released.

[0123] Specifically, the retaining support 65 preferably comprises a portion fixed to the outer wall 35 and an inclined portion that is angled away from the outer wall 35 so as to approach the slide 20. The engagement is released by the fact that the inclined portion is pressed and displaced by the release member 68 in a direction D in the drawing. Then, when the engagement between the retaining protrusion 64 and the retaining support 65 is released, the slide 20 advances to the advanced position by means of the repulsive force of the helical springs 61 in the highly compressed state generated by the retraction of the slide 20.

[0124] In the drawing, the reference sign A designates the direction of advance, and the reference sign B designates the direction of return.

[0125] The configuration of the retaining device that holds the slide 20 in the retracted position relative to the advanced position and of the retaining release device can be changed if necessary. For example, a switch for actuating the retaining release device can be provided on a side surface of the housing or similar, and a part of the device, such as a mobile or non-mobile skin pressure element, can be pressed against the skin, and the switch or similar can then be manipulated to actuate the retaining release device without being reciprocally locked with the skin pressure element.

[0126] The housing 1 includes an automatic advancement mechanism and is configured such that the slide 20 can be advanced by a push force and / or a drive mechanism to the advanced location where the injection needle 44 pierces the skin.

[0127] The automatic advance mechanism generally comprises two helical springs 61 which push the slide 20 in the advance direction A. The two The helical springs 61 are arranged such that, when the injector 40 is mounted on the slide 20, the injector 40 is located between the two helical springs 61. This makes the formation of the lateral openings 23, 33 in the assembly 30 and the slide 20 easier than in a case where the slide 20 is arranged inside a single helical spring (for example, see [Fig. 5] of JP2019-97656A). Furthermore, the movement of the slide 20 in said direction X is more stabilized compared to a case where a single helical spring 61 is arranged around the slide 20. In addition, adopting such a configuration facilitates the installation of a guide to restrict the forward / retract direction X of the slide 20 to said direction X.

[0128] According to the housing 1 of the present invention, generally, after the release of the engaged state in which the slide 20 is retracted, the slide 20 advances automatically by means of the repulsive force of the compressed helical springs 61. As a result, the injection needle 44 pierces the skin, making individual differences in puncture conditions, such as the angle of insertion relative to the skin and the insertion speed, less likely to occur.

[0129] The housing 1 of this embodiment generally includes a retaining device that mechanically retains the slide 20 in the retracted position further in the direction opposite the skin than the advanced position by mechanical engagement between the retaining protrusion 64 and the retaining support 65. In addition, a retaining release device is generally provided, which releases the engagement between the retaining protrusion 64 and the retaining support 65 and advances the slide 20 to the advanced position by means of the repulsive force of the helical springs 61 rather than manually. This allows the engagement to be released after the housing 1 has been brought close to the skin, which is the target for administration of the liquid agent, in a suitable position. Consequently, it is possible to obtain a more reliable puncture with the injection needle 44 using the housing 1.

[0130] The retention release device is preferably a mechanism that releases the mechanical grip between the retention protrusion 64 and the retention support 65 by means of the release member 68, which is reciprocally locked with the skin pressure element 71. This is activated by pressing a portion of the housing 1 against the skin. This allows the puncture to be performed with the injection needle 44 under appropriate tension applied to a region of the skin against which the injection needle 44 abuts. This also makes it possible to reduce individual differences in the pressure applied to the skin.

[0131] The housing 1 of the present invention preferably comprises the skin pressure element 71 having a substantially annular shape at an end portion in the direction towards the skin, i.e. a longer end portion close to the skin in the X direction of the slide 20's advancement / retraction. The skin pressure element, having a substantially annular shape, is preferably located on an outer side of the slide 20 in the circumferential direction. Being located on the outer side of the slide in the circumferential direction means being situated around the slide 20 when the housing 1 is viewed from the end portion in the direction towards the skin.

[0132] More preferably, the housing 1 of the present invention preferably comprises the skin pressure element 71 having a substantially annular shape which abuts against a periphery of the skin region with which the injection needle 44 comes into contact. More specifically, the assembly 30 preferably comprises the skin pressure element 71 displaced in the forward / retract direction X at a distal end portion on the skin side. Preferably, the displaced skin pressure element 71 is continuously pressed in the forward direction A by a pushing means such as helical springs 61 and retracts in the forward / retract direction X by pressure of the skin pressure element 71 against the skin.

[0133] The substantially annular shape can be a continuous annular shape, i.e. a connected configuration over 360°, and includes a shape which is partially disconnected but can be considered as an annular shape as a whole.

[0134] The skin pressure element 71 having an annular shape preferably comprises a surface parallel to a plane orthogonal to the advance / retraction direction X of the slider 20.

[0135] The housing 1 of the present invention generally comprises the skin pressure element 71 having a substantially annular shape which abuts against the periphery of the skin region with which the injection needle 44 comes into contact. This eliminates the occurrence of a height difference around the skin region with which the injection needle 44 comes into contact. Consequently, when the injection needle 44 is applied orthogonally to the skin, the inclination of the skin is eliminated, which facilitates orthogonal application.

[0136] To facilitate the retraction of the slide 20 with the injector 40 mounted thereon, preferably a button-like portion 26 having a circular arc cross-section is provided at an end portion of the slide 20 on the retraction direction side B. With the button-like portion 26 provided, the slide 20 is easily moved in the retraction direction B when squeezed or grasped by the fingers. The shape and size of the button-like portion 26 can be changed if necessary. It should be noted that a shape and size that do not interfere with the attachment of the injector 40 to the slide 20 are preferred. Alternatively, the button-like portion 26 may also be omitted.

[0137] A typical method of injecting a liquid agent into the skin using the housing 1 will now be described.

[0138] LIQUID AGENT FILLING PROCESS

[0139] First, the injection device 51 is filled with a liquid agent. Specifically, in a state where a distal end opening of the injection device 51 is immersed in the liquid agent, the piston 58 inserted in the syringe cylinder 51a is pulled upward to draw the liquid agent into the injection device 51. The injector 40 equipped with the injection needle 44 is formed by attaching the protruding tool 41 to the injection device 51 filled with the liquid agent. The piston 58 of the injection device 51 is pressed downward to fill the injection needle 44 with the liquid agent. The method of filling the liquid agent is not limited to the method described above, and any desired method may be used.

[0140] Such a liquid agent filling process can be carried out by a member of medical staff, such as a doctor, nurse, or public health nurse, at a medical site, or it can be carried out at a production site, such as a pharmaceutical or medical device manufacturer's plant. In the case of preparation at the latter site, the injector containing the liquid agent is preferably individually packaged and supplied to the medical site.

[0141] INJECTOR ASSEMBLY PROCESS

[0142] In the housing 1, both the slide 20 and the assembly 30 preferably have the lateral openings 23, 33 extending in the direction of advancement / retraction X of the slide 20. In addition, the lateral openings 23, 33 preferably open in the same direction in a cross section orthogonal to the direction of advancement / retraction X in the assembly 30.

[0143] Consequently, the injector 40 can be mounted on the slide 20 from the side of the assembly 30 through the lateral openings 23, 33. This reduces the possibility of the injection needle 44 and the housing 1 coming into contact with each other when the injector 40 is attached to the slide 20 or is detached after injection. An example of this is shown in [Fig. 9].

[0144] PUNCTURE PROCESS

[0145] Preferably, the slide 20 is moved in the retraction direction B, the helical springs 61, pushing the slide 20 in the forward direction, are compressed, and then the injector 40 is attached to the slide 20. Alternatively, the injector 40 can be attached to the slide 20 and then the slide 20 can be moved in the retraction direction B.

[0146] The slide 20 is fixed in the retracted position by the retaining device such that the compressed state of the helical springs 61 is maintained. The injection needle side 44 of the housing 1 in this state is brought close to the skin serving as the target of liquid agent administration. At this point, the axial direction X of the housing 1 is preferably set orthogonally to the skin. Then, when the retention state of the retaining device is released by the retention release device, the slide 20 retaining the injector 40 advances towards the skin and the injection needle 44 pierces the skin (see [Fig. 12]). Next, the piston 58 of the injection device 51 is pressed to inject the liquid agent into the skin.

[0147] The housing 1 according to the present invention preferably comprises a pressing protrusion 37 on the outer surface of the assembly 30, the pressing protrusion 37 serving as a finger-gripping element when the piston 58 is pressed to perform the injection operation. When the injector 40 is the injection device 51 comprising the syringe cylinder 51a and the piston 58, the injection operation is performed by pressing the piston 58 with a finger, such as a thumb. At this point, the pressure force applied to the skin may be too strong, depending on the person performing the operation. During the operation, by applying a force in a direction opposite to the direction of pressing the piston 58 on the pressing protrusion 37 with a finger other than the one pressing the piston 58, it becomes easier to control the pressure force applied to the skin.This eliminates the application of excessive force to the skin, thus reducing pain, while also allowing for easy administration of the necessary liquid agent.

[0148] To effectively perform intradermal administration, preferably the skin is not only pierced by the injection needle 44 of the injector 40 but is pierced by the injection needle 44 to an appropriate depth that allows intradermal administration. Specifically, when the puncture is performed using the injection needle 44, the opening 44a of the injection needle 44 preferably reaches an epidermis SI, and more preferably reaches a layer S12 within a stratum corneum SU (see [Fig. 12]).

[0149] The opening 44a of the injection needle 44 can reach a dermis S2 beyond the epidermis SL Even in this case, the liquid agent ejected from the opening 44a penetrates not only into the dermis S2 but also into the epidermis SI, which facilitates the injection of the liquid agent into the epidermis SL In this case, in order to ensure that the liquid agent ejected from the opening 44a penetrates into the epidermis SI, the opening 44a is preferably located at a position close to the epidermis SI in the dermis S2.

[0150] The injector 40 is preferably used for the intradermal administration of a liquid agent. Here, the injector 40 used for the intradermal administration of a liquid agent means that the opening 44a of the injection needle 44 of the injector 40 is positioned in a suitable location for intradermal administration. To this end, preferably when a height of the needle Injection port 44 is divided equally into two halves, a center of the opening 44a is located on the distal end side of the micro-needle.

[0151] The housing 1 is preferably hand-sized to facilitate the puncture operation. In the housing 1, a length L1 of the slide in the advance / retraction direction X is preferably 30 mm to 150 mm, more preferably 50 mm to 100 mm.

[0152] In order to easily mount the injector 40, a length of the lateral opening 23 of the slide 20 in the forward / retract direction X is preferably 50% to 100%, more preferably 70% or more, of the length L1 of the housing 1. The lateral opening 23 of the slide 20 preferably extends continuously over the entire length of the slide 20.

[0153] In order to easily mount the injector 40, a length of the lateral opening 33 of the assembly 30 in the forward / retract direction X of the slide 20 is preferably 50% to 100%, more preferably 70% or more, of the length L1 of the housing 1. The lateral opening 33 of the assembly 30 also preferably extends continuously over the entire length of the slide 20.

[0154] The protrusion tool 41, in order to guarantee material handling, strength, and workability of the protrusion tool 41, and hardness of the injection needle 44, and to facilitate liquid injection, preferably comprises a thermoplastic resin. The injection needle is more preferably formed from a sheet of base material containing a thermoplastic resin.

[0155] The thermoplastic resin may comprise one or two or more of two materials selected from polyolefin, polyester, polyamide, polyamide-imide, polyether ether ketone, polyetherimide, polyvinyl chloride, acrylic resin, polystyrene resin, and the like.

[0156] The polyolefin may comprise polypropylene and / or polyethylene.

[0157] Polyester may comprise one, two, or more of two selected materials including polyethylene terephthalate, fatty acid polyester, polylactic acid, polycaprolactone, polybutylene succinate, and similar.

[0158] Polyamide may contain nylon.

[0159] With a view to biodegradability, a fatty acid polyester is preferably included.

[0160] The fatty acid polyester may comprise polylactic acid and / or polyglycolic acid.

[0161] A ratio of the mass of the thermoplastic resin contained in the protruding tool 41 to the total mass of the protruding tool 41, with a view to improving the moldability and dimensional stability of the needle injection, is preferably greater than or equal to 50%, more preferably greater than or equal to 70%, and preferably even greater than or equal to 90%.

[0162] Furthermore, the ratio, with a view to providing different effects by adding a functional agent to the injection needle if necessary, is preferably less than or equal to 100%, more preferably less than or equal to 98%, and even more preferably less than or equal to 96%. As functional agents, one or two or more of two agents selected from an antibacterial agent, a bactericide, a humectant, a flow agent, an antistatic agent, a dye, and the like may be contained.

[0163] The liquid agent to be injected into the skin by injector 40 can be selected as appropriate depending on the application of injector 40.

[0164] According to the present invention, it is possible to easily administer a liquid agent intradermally, and therefore preferably the drug injected into the skin by the injector 40 is a liquid agent administered intradermally, more preferably a vaccine administered intradermally. In particular, when an intradermally administered vaccine is used, it is possible to reliably administer the drug intradermally and effectively increase antigenic recognition by the immune system compared to subcutaneous administration, and therefore an increased effect of the vaccine can be expected. The skin comprises an epidermis, a dermis, and subcutaneous tissues, in that order from the surface side of the body, and a relatively large number of immune cells are present in the epidermis and dermis.Therefore, when an intradermal vaccine is administered using injector 40, the drug is preferably administered into the epidermis and dermis to maximize the vaccine's effect. Injection at the epidermal-dermal boundary is also preferred as a method of administration. It should be noted that an intradermal drug is defined as a drug for which the recommended method of administration is intradermal.

[0165] The liquid agent may contain one or two or more of two injections selected from a vaccine intended to prevent an infectious disease, a vaccine intended to treat an infectious disease, an analgesic for patients with cancer, insulin, a biological product, and / or a gene therapy medicinal product.

[0166] The vaccine intended to prevent an infectious disease may include one or two or more of two vaccines intended to prevent an infectious disease selected from hepatitis A, hepatitis B, hepatitis C, influenza, COVID-19, tuberculosis, rabies, polio, chickenpox, rubella, measles, tetanus, and / or shingles, etc.

[0167] The vaccine intended to treat an infectious disease may preferably comprise a vaccine intended to treat one, two, or more of two diseases selected from hepatitis Chronic B, tuberculosis, rabies, a malignant neoplasm, and / or shingles, etc. The injection needle 44 pierces the skin, and therefore the injector 40 can be applied not only to pharmacologically used active substances for transdermal administration in the anterior art, but also to pharmacologically required active substances requiring subcutaneous injection.

[0168] The skin S into which the liquid agent is injected by the injector 40 may be human skin or may be the skin of an animal other than a human being.

[0169] The housing according to the present invention is preferably designed such that the injector and the slide are advanced towards the skin at a predetermined speed by means of a thrust force and / or a drive mechanism when the injector is mounted and the injection needle pierces the skin. The "speed" here is the "puncture speed during puncture by the housing" described in the examples.

[0170] The speed is preferably greater than or equal to 1,000 mm / s, more preferably greater than or equal to 1,800 mm / s. By using an injector having an injection needle with a protrusion height greater than 0 µm and less than or equal to 5,000 µm and by setting the puncture speed to such a speed, it is possible to carry out administration into the skin with little leakage from the skin in a case where the injector can be mounted on the assembly from the side as well as in a case where the injector cannot be mounted on the assembly from the side.

[0171] The speed is preferably less than or equal to 7,000 mm / s, more preferably less than or equal to 6,500 m / s. This allows control of the puncture depth of the injection needle 44 and prevents pain during the puncture.

[0172] According to the present invention, a puncture method for piercing the skin with the injection needle by advancing the injector and slide towards the skin at the speed described above by means of a pushing force and / or a drive mechanism is also provided.

[0173] The present invention relates to a kit comprising a container and an injector containing a drug solution and individually packaged. The container of the present invention described above may be used as the container included in the kit. An injector similar to the injector in the container of the present invention described above may be used as the injector. A liquid agent similar to the liquid agent used in the container of the present invention described above may be used as the liquid agent.

[0174] According to the kit of the present invention, it is possible to implement a commercial model in which a liquid agent filling process and individual packaging of an injector containing a liquid agent are carried out at a production site such as a factory of a pharmaceutical manufacturer or a medical device manufacturer, and the kit is used by a member of staff Medical personnel such as a doctor, nurse, or public health nurse at a medical site. As packaging material for individual packaging, various known materials can be used without particular limitation, and those suitable for maintaining a sanitary condition are preferable.

[0175] Although the present invention has been described above on the basis of preferred embodiments, the present invention is not limited to the embodiments described above and may be modified if necessary.

[0176] Preferably, the automatic advancement mechanism comprises one, two, or more elements selected from an elastic element and / or an actuator, and is configured to advance the injection needle 44 by means of a pushing force and / or a drive mechanism to an advanced location where the injection needles pierce the skin. For a simple structure, the automatic advancement mechanism preferably comprises an elastic element.

[0177] The elastic element preferably comprises a spring and / or rubber. In order to simplify the automatic advancement mechanism, a spring is preferably included.

[0178] The spring, in order to further simplify the configuration of the automatic advance mechanism, preferably comprises a helical spring. Since the helical spring 61 exhibits a restoring force (repulsive force) relative to compression, the helical spring 61 functions as an automatic advance mechanism. A contraction force from a stretched state of the helical springs 61 can be used.

[0179] The actuator is preferably driven by an electric motor and / or compressed air or hydraulic pressure. Various actuators driven by an electric motor or similar can also be used as a retaining device and the mechanism that releases the retaining device and advances the slide to the location where the injection needle comes into contact with the skin.

[0180] The injector may be an injector in which the needle base 47 and the injection device 51 are coupled by means of a sliding Luer fitting.

[0181] In the embodiment described above, the release member 68 is configured to press a portion of the retaining support 65 to release the engagement between the retaining protrusion 64 and the retaining support 65. However, instead of this configuration, a portion of the retaining support 65 can be pulled or slid, thereby releasing the engagement between the retaining protrusion 64 and the retaining support 65. Alternatively, a portion of the retaining support 65 can be pressed, pulled, and slid, thereby releasing the engagement between the retaining protrusion 64 and the retaining support 65. EXAMPLES

[0182] In what follows, the present invention will be described more precisely with reference to examples, but the present invention is not limited to such examples.

[0183] An injector was mounted on a housing having the configuration illustrated in [Fig.6] to 10, and the evaluation described below was carried out.

[0184] The injector was fitted with a syringe as a liquid agent container and a tool to protuberances exhibiting the configuration illustrated in [Fig.4].

[0185] As a syringe, a syringe (HJ5010-LL, Henke Sass Wolf) comprising a syringe cylinder made of polypropylene (PP) and a syringe (Clear Ject 0.5 mL LL T2, Taisei Kako Co., Ltd.) comprising a syringe cylinder made of cycloolefin polymer (COP) were used.

[0186] The protrusion tool was equipped, on a protrusion sheet, with three conical injection needles having a projection height of 2,000 sq m and an opening in a lateral surface thereof. In addition, the protrusion tool was equipped with eight first conical protrusions without openings and having a projection height of 1,400 sq m and four second protrusions without openings and having a projection height of 900 sq m and a substantially flat distal end surface.

[0187] In each of the housings, the automatic advance mechanism was a spring, and two automatic advance mechanisms were arranged to sandwich the injector in a direction orthogonal to the advance / retraction direction. The length of the housing in the advance / retraction direction was 75 mm.

[0188] In addition, a syringe was mounted from the side of the housing through the side openings of the assembly and the slide.

[0189] PUNCTURE SPEED MEASUREMENT TEST

[0190] The puncture velocity during puncture through the casing was measured by the method described below in a preliminary test using a sponge as the punctured object.

[0191] A high-precision laser displacement measuring device manufactured by Keyence Corporation was used to measure the puncture speed. In the measurement process, a laser displacement measuring device was used to acquire location information regarding the displacement of the casing caused by the puncture operation, and the puncture speed was calculated from a displacement quantity and a displacement acquisition time. The measured value was obtained by taking three measurements and averaging the measured values.

[0192] The syringe with the injection needles has been mounted on the housing and integrated into it.

[0193] The housing was arranged so that the injection needles came into contact with the sponge (chloroprene rubber sponge, 5 mm thick, Asker C25 hardness) during the puncture operation. The height of the laser displacement measuring device was adjusted so that a portion of the syringe plunger tip was positioned at a measurement reference distance and within a measurement range. After the housing was brought to a state ready for puncture, a puncture operation was performed.

[0194] During the puncture procedure, the laser tracked the piston tip, and the displacement of the injection needles was measured by measuring the piston displacement. It should be noted that the reference value for the laser displacement measurement device was a sampling period of 20 ps. The displacement and the displacement acquisition time were analyzed to determine the point at which the injection needles made contact with the sponge. The point at which the injection needles made contact with the sponge was defined as 0 mm, and the displacement from the puncture preparation procedure until the injection needles made contact with the sponge was analyzed.As the puncture velocity, a value calculated from the amount of displacement and the displacement acquisition time in a section of 1 mm to 2 mm 1 mm in front of the contact location was used.

[0195] ADMINISTRATION TEST

[0196] The device used a helical spring as an automatic advance mechanism. In addition, the repulsion force and the puncture speed were modified by changing the compression length of the helical spring using a spacer element. The slider with the syringe and the attached injection needles was retracted and held in the retracted position. The skin pressure element was pressed against the skin to release the pressure, and the skin was punctured. The drug was then injected by depressing the plunger. Excised skin from a 6-week-old male Göttingen minipig (abdomen) was used, and 100 µL of rhodamine B solution was administered as the liquid agent. This administration was performed three times. For each dose, the amount of leakage fluid that did not enter the skin was measured. The results are shown in Table 1.

[0197] [Tables] Example 1 Example 2 Example 3 Example 4 Syringe type Made of ePP Made of eCOP Made of eCOP Made of ePP Puncture speed [mm / s] 5080 4472 4326 3594 Leakage amount [mg] First time 0.2 0.0 0.0 1.6 Second time 0.0 0.0 0.0 1.0 Third time 1.2 0.0 0.0 0.9 Average 0.5 0.0 0.0 1.2

[0198] EVALUATION RESULT

[0199] The syringe was easily mounted on the slide from the side of the housing through the lateral openings in the assembly and the slide. This meant that contact between the injection needles and the housing could be eliminated. Adhesion of the liquid to the housing was checked, but no adhesion was observed.

[0200] Furthermore, in all three administrations of each example, the amount of leakage relative to the 100 qL administered was extremely small. Consequently, the puncture performance proved excellent, and the occurrence of individual differences in puncture conditions was found to be avoidable.

[0201] INDUSTRIAL APPLICABILITY

[0202] According to the present invention, a housing is provided that is suitable for eliminating contact between an injection needle and the housing and suitable for preventing the occurrence of individual differences in puncture conditions.

[0203] According to the present invention, a kit is provided suitable for removing the adhesion of a drug solution to a container.

[0204] According to the present invention, a puncture method is provided which reduces a constraint on a subject receiving an injection and / or facilitates a simple puncture.

[0205] According to the present invention, an injection method is provided which reduces a constraint on a subject receiving an injection and / or facilitates a simple injection.

Claims

Demands

1. Housing (1) for facilitating puncture with one or two or more of two injection needles (44) of an injector (40), the injection needles having a protrusion height greater than 0 pm and less than or equal to 5,000 pm, the housing comprising: a slider (20);and an assembly (30), wherein the slide is configured to detachably fix the injector and is disposed within the assembly, the assembly supports the slide, the slide is configured to advance and retract in one direction, the housing is configured to advance the injector and the slide by means of a thrust force and / or a drive mechanism to an advanced location where said one or two or more of two injection needles pierce the skin, the slide and the assembly each have a lateral opening (23, 33) extending in a direction of advancement / retraction of the slide, and the housing is configured such that the injector can be mounted on the slide from one side of the assembly through the lateral opening of the slide and the lateral opening of the assembly.

2. Housing according to claim 1, comprising one or two or more of two elements selected from a spring, rubber and / or an actuator provided to advance the injector and slide to the advanced location, wherein the spring preferably comprises a helical spring (61), and the actuator is preferably driven by an electric motor and / or compressed air or hydraulic pressure.

3. Housing according to claim 1, comprising two or more springs provided to advance the injector and slide to the advanced location, in which the two or more springs sandwich the injector in a direction orthogonal to said direction.

4. Housing according to any one of claims 1 to 3, in which the injector comprises: said one or two or more of two injection needles; a liquid agent container (50) coupled to said one or two or more of two injection needles so as to permit liquid to pass through it; and an inlet groove engaging between said one or two or more of two injection needles and the liquid agent container; and the slide comprises a fastening protrusion configured to engage with the inlet groove and having a circular arc shape in a cross-section orthogonal to said direction.

5. A housing according to any one of claims 1 to 4, wherein one element of the assembly or the slide has a guide protrusion (21a), and the other element has a groove (39), the guide protrusion is configured to mechanically engage with the groove, forming a slide, and the slide is configured to limit the advance / retraction direction of the slide to said direction, and the assembly has the groove, the groove extends in said direction on an inner wall of the assembly opposite the slide, the slide has the guide protrusion, and the guide protrusion extends in said direction on an outer wall of the slide opposite the assembly, or the assembly has the guide protrusion, the guide protrusion extends in said direction on the inner wall of the assembly opposite the slide, the slide has the groove,The groove extends in that direction on the outer wall of the slide, opposite the assembly.

6. Housing according to claim 5, wherein two or more of the slides are provided in a circumferential direction of the housing.

7. Housing according to any one of claims 1 to 6, comprising a skin pressure element (71) at an end portion in a direction towards the skin, wherein the skin pressure element is on an outside side of the slide in a circumferential direction and preferably has a substantially annular shape.

8. Housing according to any one of claims 1 to 7, comprising a retaining device; and a retaining release device, wherein the retaining device is configured to retain the slider at a retracted location that is retracted further in a direction opposite to the skin than is the advanced location, and the retaining release device is configured to release the retaining device and advance the slider to the advanced location.

9. Housing according to claim 8, wherein the retaining release device is configured to be actuated by pressing a part of the housing against the skin.

10. Housing according to any one of claims 1 to 9, wherein the slide has a retaining protrusion (64), the assembly has a retaining support (65) configured to engage with the retaining protrusion, and the retaining support mechanically retains the slide on the direction side opposite the skin of the forward location.

11. Housing according to claim 10, wherein a locked state of the retaining protrusion and the retaining support is released by pressing, pulling and / or sliding a portion of the retaining support.

12. Housing according to claim 10 or 11, comprising a skin pressure element (71) at an end portion in a direction towards the skin, wherein the retaining support and the skin pressure element are mechanically locked together by means of a release member, and a locked state of the retaining protrusion and the retaining support is configured to be released by pressure of the skin pressure element against the skin.

13. Case according to any one of claims 1 to 12, wherein the case has a size enabling it to be held in one hand.

14. Housing according to any one of claims 1 to 13, wherein a length of the housing in said direction ranges from 30 mm to 150 mm, preferably from 50 mm to 100 mm.

15. Housing according to any one of claims 1 to 14, comprising: one or two or more than two pressing protrusions (37) on an external surface of the assembly.

16. Kit comprising: the case (1) according to any one of claims 1 to 15; and the injector containing a drug solution and individually packaged.

17. Kit according to claim 16, wherein said one or two or more of two injection needles have a protrusion height of 500 pm to 5,000 pm, and preferably of 1,000 pm to 3,000 pm.

18. Kit according to claim 16 or 17, wherein said one or two or more of two injection needles have a conical shape and have an opening in a lateral surface.

19. Kit according to any one of claims 16 to 18, wherein the injector comprises one or two or more first protrusions having a conical shape and having no opening, and a protrusion height of said one or two or more first protrusions is preferably less than or equal to that of said one or two or more injection needles.

20. Kit according to any one of claims 16 to 18, wherein the injector comprises one or two or more of two second protrusions having no opening and comprising a distal end surface which is substantially flat, and a protrusion height of said one or two or more of two second protrusions is less than that of said one or two or more of two injection needles.

21. Kit according to claim 19, wherein the injector comprises one or two or more of two second protrusions having no opening and comprising a distal end surface which is substantially flat, and a protrusion height of said one or two or more of two second protrusions is less than that of said one or two or more of two injection needles and said one or two or more of two first protrusions.

22. Kit according to claim 21, in which said one, two, or more injection needles are physically coupled to the liquid agent container via a needle base, and an outer surface of the needle base (47) serves as an entry groove for engagement.

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