JP5921557B2 - applicator - Google Patents

Description

  One aspect of the present invention relates to an applicator used to assist administration of an active ingredient by a microneedle.

  2. Description of the Related Art Conventionally, an applicator for applying a microneedle to the skin by applying an impact to the microneedle for administering an active ingredient through the skin is known. For example, Patent Document 1 below describes an applicator that includes a flexible sheet having a raised central region attached to a microneedle device and a support member around or near the flexible sheet. The flexible sheet is configured to receive a stepwise movement in a direction orthogonal to the main plane of the sheet.

Special table 2008-520369 JP 2005-533625 A

  However, in the applicator described in Patent Document 1, since the center region of the flexible sheet that acts on the microneedle is directly pressed by the user, the force transmitted to the microneedle is influenced by the user's force. . Therefore, the degree of puncture varies from user to user, and as a result, the reproducibility of puncture may be reduced. Therefore, there is a demand for maintaining the degree of microneedle puncture at a certain level, that is, improving the reproducibility of puncture, regardless of who uses it.

  An applicator according to an aspect of the present invention is an applicator for applying microneedles to the skin, and has a base having an arrangement region for arranging microneedles, and a convex shape toward a side away from the base. A plate-like elastic member held between the base and the actuating member in a curved state and separated from the base, and attached to the base via a support shaft so as to be rotatable with respect to the base And an operating member that deforms the elastic member so that the top of the elastic member curved in a convex shape reaches the arrangement region while being in a convex shape toward the side approaching the base. .

  According to such a form, when the actuating member is rotated toward the base, the plate-like elastic member is bent from the convex shape toward the side away from the base (the direction away from the skin). It curves in a convex shape toward the direction of the skin. And the convexly curved top part reaches the arrangement | positioning area | region for arrange | positioning a microneedle among bases. Therefore, when the microneedle is arranged in the arrangement region, the elastic member collides with the microneedle, and the elastic member transmits the urging force due to such a series of deformation to the microneedle, so that the microneedle is applied to the skin. The The deformation of the elastic member is not caused directly by the user but is caused by the rotation of the actuating member, and the degree of the deformation is constant regardless of who uses it, so the urging force transmitted to the microneedle is also constant. It becomes. Therefore, the puncture degree of the microneedle can be kept at a certain level regardless of who uses it.

  In the applicator according to another aspect, the operating member is an arm provided so as to cover the base and the elastic member, and the first support portion provided at one end of the arm closer to the support shaft is the elastic member. While supporting the 1st end, the 2nd support provided in the other end of the arm supports the 2nd end of the elastic member, and the arm is rotated and the 2nd support is the 2nd end By pushing the vicinity toward the base, the arm is bent in a convex shape toward the side where the elastic member approaches the base, and the top of the elastic member curved in a convex shape reaches the arrangement region. In addition, the elastic member may be deformed.

  In an applicator according to another embodiment, the arm is rotated so that the second support portion pushes the vicinity of the second end portion toward the base so that the elastic member has an S-shape. The elastic member is temporarily deformed, and then the elastic member is bent in a convex shape toward the side approaching the base, and the elastic member is adjusted so that the top of the elastic member bent in a convex shape reaches the arrangement region. It may be deformed.

  In the applicator according to still another aspect, the first end portion of the elastic member may be rotatably supported with respect to the arm or the base via the rotation shaft.

  In the applicator according to another embodiment, the second end of the elastic member may be fixed to the second support.

  In the applicator according to another embodiment, the first support part is a semi-cylindrical hollow body, the second support part has a recess opening toward the first support part, and the first end part Is supported by the first support part with a degree of freedom in a state where it hits the inner wall of the first support part, and the second support part with the degree of freedom is inserted by inserting the second end into the recess. It may be supported by the part.

  In an applicator according to another embodiment, a first opening corresponding to the microneedle may be formed in the base, and the elastic member may apply the microneedle to the skin in the first opening.

  In the applicator according to another embodiment, the arm may be formed with a second opening facing the first opening.

  In an applicator according to another embodiment, the operating member is a lever extending upward from the base, and the first support portion provided on the base supports the first end portion of the elastic member and is formed on the lever. The second support portion supports the second end portion of the elastic member, and the lever is rotated so that the second support portion pushes the vicinity of the second end portion toward the base. The elastic member may be deformed so that the top portion of the elastic member curved in a convex shape reaches the arrangement region while being in a convexly curved state toward the side approaching.

  In the applicator according to still another embodiment, the lever is rotated so that the second support portion pushes the vicinity of the second end portion toward the base, so that the elastic member becomes an S-shaped elastic member. Then, the elastic member is deformed so that the elastic member is curved in a convex shape toward the side closer to the base, and the top of the convex elastic member reaches the arrangement region. May be.

  In the applicator according to another aspect, the first end of the elastic member may be supported so as to be rotatable with respect to the base via the rotation shaft.

  In the applicator according to another embodiment, the second end of the elastic member may be fixed to the second support.

  In an applicator according to another embodiment, the first support portion is a semi-cylindrical hollow body, the second support portion is a recess that opens toward the first support portion, and the first end portion is the first end portion. 1 is supported by the first support part with a degree of freedom in contact with the inner wall of the support part, and the second end part is supported by the second support part with a degree of freedom by being inserted into the recess. May be.

  In the applicator according to another embodiment, a pressing member for pressing the microneedle toward the skin may be provided in the first opening.

  An applicator according to another embodiment is an applicator for applying microneedles to the skin, and has a base having an arrangement region for arranging microneedles, and a convex curve toward a side away from the base. And a plate-like elastic member arranged in a state of being separated from the base, and attached to the base so as to be movable with respect to the base. The elastic member is convex toward the side approaching the base. And an actuating member that deforms the elastic member so that the top of the elastic member curved in a convex shape reaches the arrangement region.

  Further, an applicator according to another embodiment includes a base, a plate-like elastic member that is curved in a convex shape toward the side away from the base and spaced from the base, and the base of the elastic members. A microneedle disposed on an opposite surface and an operating member attached to the base via a support shaft so as to be rotatable with respect to the base, the base having a passage region through which the microneedle can pass. The actuating member curves the elastic member in a convex shape toward the side approaching the base, and deforms the elastic member so that the top portion and the microneedle pass through the passage region. To apply.

  According to one aspect of the present invention, the puncture degree of the microneedle can be maintained at a certain level regardless of who is using it.

FIG. 1 is a perspective view from above of the applicator according to the first embodiment. FIG. 2 is a perspective view from below of the applicator shown in FIG. FIG. 3 is a side view of the applicator shown in FIG. FIG. 4 is a top view of the applicator shown in FIG. FIG. 5 is a bottom view of the applicator shown in FIG. FIG. 6 is a front view of the applicator shown in FIG. 1 as viewed from the guide unit side. FIG. 7 is a rear view of the applicator shown in FIG. 1 as viewed from the support shaft side. 8 is a cross-sectional view taken along line VIII-VIII in FIG. FIG. 9 is a diagram showing stepwise deformation of the leaf spring in the first embodiment. FIG. 10 is a perspective view from below of the activated applicator. FIG. 11 is a perspective view from above (front) of the applicator according to the second embodiment. 12 is a perspective view from above (rear) of the applicator shown in FIG. 13 is a perspective view from below of the applicator shown in FIG. FIG. 14 is a diagram showing stepwise deformation of the leaf spring in the second embodiment. FIG. 15 is a perspective view from below of the activated applicator. FIG. 16 is a perspective view from below of an applicator according to a modification.

  Hereinafter, embodiments of the present invention will be described in detail with reference to the accompanying drawings. In the description of the drawings, the same or equivalent elements are denoted by the same reference numerals, and redundant description is omitted.

(First embodiment)
First, the structure of the applicator 10 according to the first embodiment will be described with reference to FIGS. FIG. 1 is a perspective view of the applicator 10 from above. FIG. 2 is a perspective view of the applicator 10 from below. FIG. 3 is a side view of the applicator 10. FIG. 4 is a top view of the applicator shown in FIG. FIG. 5 is a bottom view of the applicator shown in FIG. FIG. 6 is a front view of the applicator shown in FIG. 1 as viewed from the guide unit side. FIG. 7 is a rear view of the applicator shown in FIG. 1 as viewed from the support shaft side. 8 is a cross-sectional view taken along line VIII-VIII in FIG.

  The applicator 10 is an auxiliary instrument used for applying a microneedle to the skin. The applicator 10 has a shape like a stapler. The applicator 10 includes a base 20 having a bottom surface 21 in contact with the skin, and an arm (actuating member) 30 provided so as to cover the base 20 from above. The rear end of the arm 30 is attached to the rear end of the base 20 by a support shaft 40 extending in the width direction (short direction) of the base 20, and the front end of the arm 30 moves in the vertical direction within a predetermined movable range. It is possible. This means that the arm 30 can rotate within the movable range in a direction toward the base 20 or away from the base 20.

  A bottom surface 21 of the base 20 has a rectangular shape, and an opening (first opening) 22 is formed at a substantially central portion thereof. The opening 22 has a shape such as a combination of a rectangle extending along the front-rear direction (longitudinal direction) of the base 20 and a circle located substantially at the center of the rectangle. A region having a circular edge in the opening 22 is formed according to the shape of the microneedle, and the microneedle is disposed in the circular region (arrangement region) when the applicator 10 is used. Therefore, this circular area corresponds to the microneedle.

  A support plate 23 extending in the upward direction is provided at the front end of the upper surface of the base 20. The support plate 23 is a member for supporting a gripping portion 70 described later from below, and is attached along the width direction (short direction) of the base 20. Further, a pair of guide portions 24 are provided at positions slightly rearward of the support plate 23 so as to be arranged at regular intervals along the width direction of the base 20. The guide portion 24 is an annular member that is elongated vertically to limit the range of rotation of the arm 30 (the range of vertical movement of the front end of the arm 30). Hereinafter, a hole formed in the guide portion 24 and extending in the vertical direction is referred to as a guide hole 24a.

  A cross section in the width direction of the arm 30 is formed in a U-shape that opens downward, and thus a space is formed inside the arm 30. A substantially square opening (second opening) 31 is formed on the upper surface of the arm 30. The opening 31 is formed so as to face the circular region of the opening 22 of the base 20, that is, the location of the microneedle when the applicator 10 is looked down from directly above. That is, the opening 31 is formed at a position facing the opening 22. A shaft portion 41 extending in the width direction of the arm 30 is attached to the lower side near the front end of the arm 30. Since the shaft portion 41 is attached so as to penetrate the pair of guide portions 24, the rotation range of the arm 30 is limited by the guide holes 24a.

  A leaf spring (plate-shaped elastic member) 50 extending along the front-rear direction of the arm 30 is provided between the base 20 and the arm 30. More specifically, the leaf spring 50 is provided so as to be accommodated in the internal space of the arm 30 in a state curved convexly toward the side away from the base 20 and separated from the base 20. .

  The rear end (first end) of the leaf spring 50 is held by a semi-cylindrical hollow body (first support portion) 60 provided in the vicinity of the support shaft 40. However, the rear end of the leaf spring 50 is not fixed in the hollow body 60 and is merely in contact with the inner wall thereof. Therefore, the leaf spring 50 has a rear end constant with respect to the inner wall of the hollow body 60. It is only held by the hollow body 60 in a movable state with a degree of freedom. The hollow body 60 may be provided on the arm 30, may be provided on the holding portion 40 a that is located at the rear end of the base 20 and holds the support shaft 40, or may be provided on the base 20. It may be.

  On the other hand, the front end (second end) of the leaf spring 50 is gripped by a gripping portion (second support portion) 70. The gripping part 70 is attached to a position between the pair of guide parts 24 by a shaft part 41, and is rotatable around a place in contact with the support plate 23. The gripping portion 70 is formed with a recess 71 that opens rearward (toward the hollow body 60 side), and the front end of the leaf spring 50 is inserted into the recess 71. The front end of the leaf spring 50 is not fixed in the gripping portion 70, and therefore the leaf spring 50 is gripped by the gripping portion 70 in a state where the front end can move within the recess 71 with a certain degree of freedom. There are only.

  The dimensions of the applicator 10 itself and the dimensions of each member constituting the applicator 10 may be determined in consideration of the dimensions of the microneedle, ease of use, and the like. For example, if the opening 22 of the base 20 is molded according to the microneedle as described above, the applicator 10 does not shift with respect to the microneedle when the applicator 10 is positioned on the microneedle. Therefore, the leaf spring 50 can be surely collided with the microneedle and puncture can be performed reliably (reproducibility of puncture is improved). In addition, the method of determining a dimension is not limited to these.

  The material of the applicator 10 is not limited. For example, in addition to synthetic or natural resin materials such as ABS resin, polystyrene, polypropylene, polyacetal (POM) resin, etc., silicon, silicon dioxide, ceramic, metal (stainless steel, titanium, nickel, molybdenum, chromium, cobalt, etc.) are used. May be. Examples of the material of the leaf spring 50 include polyacetal (POM) resin, but are not limited thereto. For example, the leaf spring 50 may be manufactured using the same material as the microneedle.

  Next, a method of using the applicator 10 will be described with reference to FIGS. FIG. 9 shows the deformation of the leaf spring 50 in stages. FIG. 10 is a perspective view of the activated applicator 10 from below.

  The applicator 10 before use is in a state where the arm 30 is raised. At this time, the leaf spring 50 is in a state in which a gentle arc is drawn upward in the internal space of the arm 30. The user first places the microneedle Da on the skin S, and then places the applicator 10 on the skin S so that the circular portion of the opening 22 of the base 20 surrounds the microneedle Da. Since the opening 31 is formed on the upper surface of the arm 30, the user can accurately position the applicator 10 with respect to the microneedle Da by looking into the inside of the applicator 10 from the opening 31. . In addition, before positioning the applicator 10, the microneedle Da may be affixed on the skin with the cover material Db (refer FIG. 9).

  The user operates the applicator 10 by pushing the vicinity of the front end of the upper surface of the arm 30 to administer the active ingredient applied to the microneedles. When the user starts to push the arm 30 (see arrow Aa in FIG. 9), the arm 30 rotates toward the base 20 around the support shaft 40. During this rotation, as the shaft portion 41 moves downward along the guide hole 24a, the gripping portion 70 attached to the shaft portion 41 rotates around the portion in contact with the support plate 23. . With this rotation, the concave portion 71 of the grip portion 70 faces downward, and as a result, the grip portion 70 presses the front end portion of the leaf spring 50 downward. By this pressing, the leaf spring 50 is curved convexly toward the arm 30 as a whole (curved toward the arm 30), and a predetermined urging force (elastic force) is accumulated in the leaf spring 50. More specifically, the leaf spring 50 is deformed into a substantially S shape when viewed from the side.

  Thereafter, when the arm 30 is pushed until the shaft portion 41 is lowered to the vicinity of the lower end of the guide hole 24a (see arrow Ab in FIG. 9), the gripping portion 70 is further rotated and the front end portion of the leaf spring 50 is further moved by the gripping portion 70. Pressed down. Then, the leaf spring 50 curved upward cannot be resisted by the urging force and is curved convexly toward the base 20 (curved toward the base 20) (see also FIG. 10). Due to this instantaneous deformation, the central portion of the leaf spring 50 (the top portion of the leaf spring 50 that is convex toward the side closer to the base 20) reaches the opening 22 of the base 20, and the microneedle is located near the opening 22. Collide with Da. By this collision, the needle portion of the microneedle Da perforates the stratum corneum of the skin, and the active ingredient applied to the microneedle Da is administered into the body through the needle portion.

  When the user stops pressing the arm 30 after using the applicator 10 as described above, the arm 30 rotates upward by the biasing force of the leaf spring 50, and the applicator 10 returns to the initial state. Therefore, when the applicator 10 is used next time, the user may position and hold the applicator 10 returned to the initial state on another microneedle and push the arm 30 toward the skin. Accordingly, applicator 10 is a self-actuating applicator.

  As described above, according to the present embodiment, when the arm 30 rotates toward the base 20, the leaf spring 50 provided between the arm 30 and the base 20 moves in the direction of the arm 30 (the base 20 And once curved in a convex manner (in a direction away from the skin), then curved in a convex manner in the direction of the base 20 (toward the skin). And the microneedle is applied to skin because the leaf | plate spring 50 transmits the urging | biasing force (elastic force) by such a series of deformation | transformation to a microneedle. The deformation of the leaf spring 50 is not directly performed by the user, but is caused by the rotation of the arm 30, and the degree of the deformation is constant regardless of who uses it. It becomes constant. Therefore, the puncture degree of the microneedle can be kept at a certain level regardless of who uses it.

  In the first embodiment, the both ends of the leaf spring 50 are supported by the hollow body 60 and the gripping portion 70 so as to have a degree of freedom, but one end or both ends of the elastic member may be fixed to the corresponding supporting portion. Good. Moreover, the structure of the 1st support part and 2nd support part which support an elastic member may differ from the hollow body 60 and the holding part 70. FIG.

  Moreover, although the opening 31 was formed in the upper surface of the arm 30 in 1st Embodiment, this opening 31 is not essential.

  In the first embodiment, the rear end of the leaf spring 50 is held by the hollow body 60 so as to be movable with a certain degree of freedom. However, the rear end of the leaf spring 50 is connected to the base 20 or the arm 30 via the rotation shaft. It may be attached to be rotatable.

  In the first embodiment, the arm 30 is provided on the base 20 so as to be movable toward the base 20. However, the arm 30 is configured so that the arm 30 moves linearly with respect to the base 20. May be provided. Specifically, the arm 30 may be in the form of a push button.

  In the first embodiment, the leaf spring 50 is once bent in the direction away from the base 20 and then bent in the direction of the base 20 to transmit the urging force of the leaf spring 50 to the microneedle Da. However, the urging force of the leaf spring 50 may be transmitted to the microneedle Da by curving in the direction of the base 20 from the state of being curved away from the base 20 without once curving in the direction away from the base 20. .

(Second Embodiment)
Next, the structure of the applicator 100 according to the second embodiment will be described with reference to FIGS. 11 and 12 are perspective views from above of the applicator 100, FIG. 11 is a view seen from the front, and FIG. 12 is a view seen from the rear. FIG. 13 is a perspective view of the applicator 100 from below.

  The applicator 100 includes a base 110 having a bottom surface 111 in contact with the skin, and a lever (actuating member) 120 provided on the front end side of the top surface of the base 110. One end (lower end) of the lever 120 is attached to the base 110 by a support shaft 130 extending in the width direction (short direction) of the base 110. The lever 120 is rotatable within a predetermined movable range in a direction toward the base 110 or away from the base 110.

  An opening (first opening) 112 is formed in a substantially central portion of the bottom surface 111 of the base 110. The opening 112 has a shape such as a combination of a rectangle extending along the front-rear direction (longitudinal direction) of the base 110 and a circle located substantially at the center of the rectangle. A region having a circular edge in the opening 112 is formed according to the shape of the microneedle, and the microneedle is disposed in the circular region (arrangement region) when the applicator 100 is used. Thus, the opening 112 is formed in the same manner as the opening 22 in the first embodiment.

  Above the base 110, a leaf spring (plate-like elastic member) 140 that extends along the front-rear direction of the base 110 is provided. More specifically, the leaf spring 140 is held between the hollow body 150 and the recess 121 in a state of being convexly curved toward the side away from the base 110 and being separated from the base 110.

  The rear end (first end) of the leaf spring 140 is held by a semi-cylindrical hollow body (first support portion) 150 provided at the rear end of the base 110. However, the rear end of the leaf spring 140 is not fixed in the hollow body 150 and is just in contact with the inner wall thereof. Therefore, the leaf spring 140 has a rear end constant with respect to the inner wall of the hollow body 150. It is only held by the hollow body 150 in a movable state with a degree of freedom.

  On the other hand, the front end (second end) of the leaf spring 140 is inserted into a recess 121 formed in a substantially central portion of the rear surface of the lever 120. The front end of the leaf spring 140 is not fixed in the recess 121, and therefore the leaf spring 140 is only held by the lever 120 with the front end having a certain degree of freedom in the recess 121. Absent.

  The dimensions of the applicator 100 itself and the dimensions of each member constituting the applicator 100 may be arbitrarily determined as in the applicator 10 according to the first embodiment. Moreover, the material of the applicator 100 and the leaf | plate spring 140 can also be selected similarly to the applicator 10 which concerns on 1st Embodiment.

  Next, the usage method of the applicator 100 is demonstrated using FIG. FIG. 14 shows the deformation of the leaf spring 140 in stages. FIG. 15 is a perspective view from below of the activated applicator 100.

  The applicator 100 before use is in a state where the lever 120 is raised. At this time, the leaf spring 140 is in a state where a gentle arc is drawn upward. The user first places the microneedle Da on the skin S, and then places the applicator 100 on the skin S so that the circular portion of the opening 112 of the base 110 surrounds the microneedle Da. Also in the present embodiment, the microneedle Da may be attached to the skin with the cover material Db (see FIG. 14).

  The user operates the applicator 100 by tilting the lever 120 behind the applicator 100 to administer the active ingredient applied to the microneedles. When the user starts to tilt the lever 120 (see arrow Ac in FIG. 14), the lever 120 rotates toward the base 110 about the support shaft 130. During this rotation, the wall of the recess 121 presses the front end portion of the leaf spring 140 downward. By this pressing, the leaf spring 140 is curved upwardly as a whole (curved in a direction away from the base 110), and a predetermined urging force (elastic force) is accumulated in the leaf spring 140. More specifically, the leaf spring 140 is deformed into a substantially S shape when viewed from the side.

  Thereafter, when the lever 120 is further tilted (see arrow Ad in FIG. 14), the front end portion of the leaf spring 140 is further pressed by the wall of the recess 121. Then, the leaf spring 140 that has been curved upward cannot resist the urging force and is curved convexly toward the base 110 (curved in the direction of the base 110) (see also FIG. 15). Due to this instantaneous deformation, the central portion of the leaf spring 140 (the top portion of the leaf spring 140 that is convex toward the side closer to the base 110) reaches the opening 112 of the base 110, and the microneedle near the opening 112. Collide with Da. By this collision, the needle portion of the microneedle Da perforates the stratum corneum of the skin, and the active ingredient applied to the microneedle Da is administered into the body through the needle portion.

  When the user stops the operation of the lever 120 after using the applicator 100 as described above, the lever 120 rises due to the urging force of the leaf spring 140, and the applicator 100 returns to the initial state. Accordingly, applicator 100 is also a self-actuating applicator.

  As described above, according to the present embodiment, when the lever 120 rotates toward the base 110, the leaf spring 140 is once convexly bent in a direction away from the base 110 and the skin, and then the direction of the base 110. Curved convexly (towards the skin). And the microneedle is applied to skin because the leaf | plate spring 140 transmits the urging | biasing force by such a series of deformation | transformation to a microneedle. The deformation of the leaf spring 140 is not directly performed by the user, but is caused by the rotation of the lever 120. The degree of the deformation is constant regardless of who uses it. It becomes constant. Therefore, the puncture degree of the microneedle can be kept at a certain level regardless of who uses it.

  In the second embodiment, both ends of the leaf spring 140 are supported by the hollow body 150 and the recess 121 so as to have a degree of freedom. However, one end or both ends of the elastic member may be fixed to a corresponding support portion. . Moreover, the structure of the 1st support part and 2nd support part which support an elastic member may differ from the hollow body 150 and the recessed part 121. FIG.

  In the second embodiment, the rear end of the leaf spring 140 is held by the hollow body 150 so as to be movable with a certain degree of freedom. However, the rear end of the leaf spring 140 rotates with respect to the lever 120 via the rotation shaft. It may be attached as possible.

  In the second embodiment, the lever 120 is provided on the base 110 so as to move rotatably toward the base 20. However, the lever 120 moves so as to move linearly with respect to the base 110. May be provided. Specifically, the lever 120 may be in the form of a push button.

  In the second embodiment, the urging force of the leaf spring 140 is transmitted to the microneedle Da by bending the leaf spring 140 once in a direction away from the base 110 and then in the direction of the base 110. However, the urging force of the leaf spring 140 may be transmitted to the microneedle Da by bending in the direction of the base 110 from the state of being bent in the direction away from the base 110 without once bending in the direction away from the base 110. .

  EXAMPLES Hereinafter, although this invention is demonstrated concretely based on an Example, this invention is not limited to them at all.

  Puncture performance was evaluated for the same applicator as the applicator 10 according to the first embodiment. Puncture performance was evaluated by administering ovalbumin (Ovalbumin: OVA) to in vitro (human skin) using a microneedle and determining the amount of OVA transferred to human skin. Here, the transfer amount is the amount of OVA adhered to the microneedles that is administered to the skin.

  The total length, width, and height of the applicator in the initial state were 72 mm, 28 mm, and 27 mm, respectively, and the height of the applicator when the arm was pushed down was 21 mm. The base length, width, and thickness were 69 mm, 28 mm, and 2 mm, respectively. The leaf spring was made of POM resin, and the length, width, and thickness were 51 mm, 8 mm, and 1 mm, respectively.

The microneedles were made of polylactic acid, the area of the substrate was 1.13 cm ² , and the number of microprojections (needles) was 640. The height of the microprotrusions was 500 μm, and the area of the flat portion at the tip thereof was 64-144 μm ² . The coating range when OVA was applied to each microprotrusion was a range of about 180 μm including the apex of the microprotrusion. The total amount (initial content) of OVA applied to the microneedles was 49.8 ± 0.9 μg.

  The OVA was extracted by immersing the microneedle peeled from the human skin after administration of OVA in phosphate buffered saline (PBS), and the transfer amount and transfer rate were reduced by subtracting the extracted OVA amount from the initial application amount. Asked. As a result, the migration rate was 50%, and it was confirmed that the active ingredient could be administered into the skin using an applicator.

  The present invention has been described in detail based on the embodiments. However, the present invention is not limited to the above embodiment. The present invention can be variously modified without departing from the gist thereof.

  A member (pressing member) for pressing the microneedle applied to the skin from above may be provided above the opening of the base. FIG. 16 shows an example in which two pressing members 25 are provided in the applicator 10 according to the first embodiment. The two pressing members 25 are provided so as to cover two circular regions of the opening 22. Since the microneedle is pressed against the skin by the pressing member 25, the degree of contact of the microneedle with the skin is kept substantially constant regardless of the user and the use site, so that the degree of puncture of the microneedle is constant. Can be kept at a level. Naturally, also in the applicator 100 according to the second embodiment, the same pressing member 25 can be provided in two circular regions of the opening 112.

  In each of the above-described embodiments, the microneedle is applied to the skin by causing the elastic member to collide with the microneedle previously applied to the skin. However, the application method of the microneedle is not limited to this. For example, even when the applicator 10 or 100 is modified so that the microneedle can be attached to the elastic member in advance, the user operates the arm 30 or the lever 120 as in the above embodiment to attach the microneedle to the skin. Can be applied.

  In each of the above embodiments, the applicators 10 and 100 and the microneedles Da are separate bodies, but the applicator may include microneedles. For example, the microneedle or a member having a microneedle may be disposed on the surface (lower surface) of the leaf spring 50 on the side facing the base 20. In this case, when the user operates the applicators 10 and 100 with the applicators 10 and 100 placed on the skin S, the central portion of the leaf spring 50 (toward the side closer to the base 20 of the leaf spring 50). The convex top) and the microneedle pass through the openings 22 and 112 (passing region), and the needle portion of the microneedle perforates the stratum corneum of the skin.

  DESCRIPTION OF SYMBOLS 10 ... Applicator, 20 ... Base, 22 ... Base opening (first opening), 23 ... Support plate, 24 ... Guide part, 24a ... Guide hole, 25 ... Holding member, 30 ... Arm (actuating member), 31 ... Arm opening (second opening), 40 ... support shaft, 41 ... shaft portion, 50 ... leaf spring (elastic member), 60 ... hollow body (first support portion), 70 ... gripping portion (second support portion), 71: Recessed part of gripping part, 100 ... Applicator, 110 ... Base, 112 ... Opening of base (first opening), 120 ... Lever (actuating member), 121 ... Recessed part of lever (second supporting part), 130 ... Support Shaft, 140: leaf spring (elastic member), 150: hollow body (first support part).

Claims (18)

An applicator for applying a microneedle to the skin,
A base having an arrangement region for arranging the microneedles;
A plate-like elastic member arranged in a convexly curved state toward the side away from the base and separated from the base;
It is attached to the base via a support shaft so as to be rotatable with respect to the base, the elastic member is curved in a convex shape toward the side approaching the base, and the top reaches the arrangement region. And an actuating member that deforms the elastic member. The operating member is an arm provided to cover the base and the elastic member;
A first support portion provided at one end portion of the arm closer to the support shaft supports the first end portion of the elastic member, and a second support portion provided at the other end portion of the arm includes the first support portion. Supporting the second end of the elastic member;
When the arm is rotated and the second support portion pushes the vicinity of the second end portion toward the base, the arm curves the elastic member in a convex shape toward the side approaching the base, The applicator according to claim 1, wherein the elastic member is deformed so that a top portion thereof reaches the arrangement region.   When the arm is rotated and the second support portion pushes the vicinity of the second end portion toward the base, the arm temporarily deforms the elastic member into an S shape, and then the elastic member The applicator according to claim 2, wherein the elastic member is deformed so that the top portion reaches the arrangement region by curving in a convex shape toward the side approaching the base.   The applicator according to claim 2 or 3, wherein the first end portion of the elastic member is rotatably supported with respect to the arm or the base via a rotation shaft.   The applicator according to any one of claims 2 to 4, wherein the second end portion of the elastic member is fixed to the second support portion. The first support part is a semi-cylindrical hollow body;
The second support part has a recess opening toward the first support part;
The first end portion is supported by the first support portion with a degree of freedom in a state where it hits the inner wall of the first support portion,
The applicator according to claim 2 or 3, wherein the second end portion is inserted into the concave portion and is supported by the second support portion with a degree of freedom. A first opening corresponding to the microneedle is formed in the base,
The applicator according to any one of claims 2 to 6, wherein the elastic member applies the microneedle to the skin in the first opening.   The applicator according to claim 7, wherein a second opening facing the first opening is formed in the arm.   The applicator according to claim 7 or 8, wherein a pressing member for pressing the microneedle toward the skin is provided in the first opening. The actuating member is a lever extending upward from the base;
A first support provided on the base supports the first end of the elastic member, and a second support formed on the lever supports the second end of the elastic member,
When the lever is rotated and the second support portion pushes the vicinity of the second end portion toward the base, the lever curves the elastic member in a convex shape toward the side approaching the base, The applicator according to claim 1, wherein the elastic member is deformed so that a top portion thereof reaches the arrangement region.   When the lever is rotated and the second support portion pushes the vicinity of the second end portion toward the base, the lever temporarily deforms the elastic member into an S shape, and then the elastic member The applicator according to claim 10, wherein the elastic member is deformed so that a top portion of the elastic member is curved toward a side approaching the base and a top portion thereof reaches the arrangement region.   The applicator according to claim 10 or 11, wherein the first end portion of the elastic member is rotatably supported with respect to the base via a rotation shaft.   The applicator according to any one of claims 10 to 12, wherein the second end portion of the elastic member is fixed to the second support portion. The first support part is a semi-cylindrical hollow body;
The second support part is a recess opening toward the first support part;
The first end portion is supported by the first support portion with a degree of freedom in a state where it hits the inner wall of the first support portion,
The applicator according to claim 10 or 11, wherein the second end portion is inserted into the concave portion and is supported by the second support portion with a degree of freedom. A first opening corresponding to the microneedle is formed in the base,
The applicator according to any one of claims 10 to 14, wherein the elastic member applies the microneedles to the skin in the first opening.   The applicator according to claim 15, wherein a pressing member for pressing the microneedles toward the skin is provided in the first opening. An applicator for applying a microneedle to the skin,
A base having an arrangement region for arranging the microneedles;
A plate-like elastic member arranged in a convexly curved state toward the side away from the base and separated from the base;
The elastic member is attached to the base so as to be movable with respect to the base, the elastic member is curved in a convex shape toward the side approaching the base, and the top of the elastic member reaches the arrangement region. An applicator comprising: an actuating member that deforms. Base and
A plate-like elastic member arranged in a convexly curved state toward the side away from the base and separated from the base;
A microneedle disposed on a surface of the elastic member facing the base;
An actuating member attached to the base via a support shaft so as to be rotatable with respect to the base;
The base has a passage region through which the microneedle can pass,
The actuating member bends the elastic member in a convex shape toward the side approaching the base, and deforms the elastic member so that the top portion and the microneedle pass through the passage region, whereby the microneedle An applicator that applies to the skin.

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