Fine needle part, injection device, and puncture injection set

Abstract

Provided is a fine needle part 1 for attachment to a skin puncture instrument, the fine needle part comprising a plate-like plate substrate, a plurality of base portions 113 protruding from an object-facing surface of the plate substrate, and a plurality of needle portions 114 respectively protruding from the top surfaces of the plurality of base portions 113. Each of the plurality of needle portions 114 has a height (b) of 5 μm ≤ b < 700 μm. Each of the plurality of base portions 113 has a height (a) of 200 μm ≤ a < 3000 μm. The total height (a + b) of the height (b) of each needle portion and the height (a) of a corresponding base portion is 600 μm to 3200 μm. The plurality of base portions 113 and the plurality of needle portions 114 are formed of an insoluble resin material. The needle portions 114 puncture the object, thereby applying a liquid onto or into the surface of the object.

Description

Fine needle parts, injection devices, and puncture infusion sets

[0001] The present invention relates to a fine needle part, an injection device, and a puncture infusion set.

[0002] In recent years, many cosmetic devices using needles have been developed. For example, a stamp-type needle applicator in which a plurality of needles (microneedles) are arranged in a row has been proposed (see Patent Document 1).

[0003] However, when multiple needles as in Patent Document 1 are used to puncture an elastic membrane such as the skin, the skin may deform, resulting in many of the multiple needles being difficult to puncture.

[0004] On the other hand, Patent Document 2 proposes a technique for puncturing the skin even if the skin is deformed, in which an adjustment section that surrounds the needle and a cylindrical stabilizing section are provided around the needle.

[0005] In recent years, microneedle masks have also become known, in which dissolving microneedles are attached to the skin and left on, allowing beauty ingredients to penetrate the skin (see, for example, Patent Document 3).

[0006] Japanese Utility Model Registration No. 3218898 Japanese Patent Application Publication No. 2012-029723 Japanese Patent No. 6682783

[0007] However, in an assembly such as that in Patent Document 2, the needle can reliably puncture the skin by deforming it with a cylindrical stabilizing part, but because the needle is provided in only one place in the center and liquid is dispensed from only one place, the area where the liquid is dispensed is small.Furthermore, because it is an assembly, it is not possible to increase the number of puncture points.

[0008] Furthermore, in the mask-type microneedles described in Patent Document 3, the microneedles and cosmetic ingredients are integrally formed, so they need to be left for a long time to inject the cosmetic ingredients dissolved in the microneedles into the skin. Furthermore, the cosmetic ingredients that can be integrated with the microneedles are limited.

[0009] In view of the above circumstances, the present invention provides a method for providing a liquid composition with any active ingredient to a subject by reliably puncturing the subject with multiple fine needles even if the subject is deformed without leaving it for a long period of time.

[0010] In order to solve the above problems, one aspect of the present invention provides a fine needle part to be attached to a skin puncture device, comprising: a plate-shaped plate substrate; a plurality of base portions protruding from a surface of the plate substrate facing an object; and a plurality of needle portions protruding from the top surfaces of each of the plurality of base portions, wherein the height (b) of each needle portion of the plurality of needle portions is 5 μm≦b<700 μm, the height (a) of each base portion of the plurality of base portions is 200 μm≦a<3000 μm, the total height (a+b) of the height (b) of each needle portion and the height (a) of each base portion is 600 μm to 3200 μm, the plurality of base portions and the plurality of needle portions are formed from an insoluble resin material, and the needle portions puncture the object to supply liquid onto or into the surface of the object.

[0011] According to one embodiment, the fine needle parts allow multiple fine needles to reliably puncture the target even if the target is deformed, without having to be left unattended for a long period of time, and a liquid composition with any active ingredient can be administered to the target.

[0012] 9 is an overall cross-sectional view of a syringe set in which a fine needle part according to a first embodiment of the present invention is attached to a syringe barrel. FIG. 1 is an exploded view of the syringe set of FIG. 1 , a fine needle plate which is a fine needle part, and an attachment frame. FIG. 2 is a cross-sectional perspective view of a fine needle part including a fine needle plate and an attachment frame according to a first configuration example of the first embodiment. FIG. 3 is an enlarged bottom view of the fine needle part according to the first configuration example of the first embodiment. FIG. 4 is a cross-sectional view showing puncturing and liquid flow in the fine needle part according to the first embodiment. FIG. 5 is a cross-sectional perspective view of a fine needle part according to a second configuration example of the first embodiment. FIG. 6 is a cross-sectional perspective view of a fine needle part according to a third configuration example of the first embodiment. FIG. 7 is a cross-sectional perspective view of a fine needle part according to a fourth configuration example of the first embodiment. FIG. 8 is a cross-sectional perspective view of a fine needle part according to a fifth configuration example of the first embodiment. FIG. 9 is a cross-sectional view showing puncturing and liquid flow in the fine needle part of FIG. 9. FIG. 10 is a cross-sectional perspective view of a fine needle part according to the first configuration example of the second embodiment. FIG. 11 is a view showing a state in which liquid is being injected into a target object from the fine needle part according to the second embodiment. FIG. 12 is a cross-sectional view of a fine needle part according to the second configuration example of the second embodiment. 1 is a cross-sectional view of a fine needle part according to a third configuration example of the second embodiment. 2 is a cross-sectional view of a fine needle part according to a fourth configuration example of the second embodiment. 3 is a cross-sectional perspective view of a fine needle part according to the third embodiment. 4 is a view showing a state in which a liquid is being injected into a target object from the fine needle part according to the third embodiment. 5 is an explanatory view of a first modified example of a needle portion of a lipped two-stage needle according to the third embodiment. 6 is an explanatory view of a second modified example of a needle portion of a lipped two-stage needle according to the third embodiment. 7 is an explanatory view of a third modified example of a needle portion of a lipped two-stage needle according to the third embodiment. 8 is a cross-sectional view of a fine needle part according to a first configuration example of the fourth embodiment. 9 is a bottom view of a fine needle part according to the fourth embodiment. 10 is a cross-sectional view of a fine needle part according to a second configuration example of the fourth embodiment. 11 is a bottom view of a fine needle part according to a third configuration example of the fourth embodiment. 12 is an overall view of a knock-type injection device according to application example 2, in which a fine needle part according to one embodiment of the present invention is mounted. 13 is an overall cross-sectional view of an injection device according to application example 3, in which a fine needle plate according to one embodiment of the present invention is mounted. 14 is an overall cross-sectional view of a needle applicator according to application example 4, in which a fine needle plate according to one embodiment of the present invention is mounted. 1 is an overall cross-sectional view of a push-head type injection device, which is Application Example 5, equipped with a fine needle plate according to one embodiment of the present invention. 2 is an overall explanatory diagram of a puncturing and applying roller, which is Application Example 6, equipped with a fine needle plate according to one embodiment of the present invention. 3 is an overall explanatory diagram of a liquid-separate type puncturing and applying roller, which is Application Example 6, equipped with a fine needle plate according to one embodiment of the present invention.35. A table showing the results of a puncture experiment on a fine needle plate of a first configuration example of the first embodiment using a base with a different length. 36. A table showing the results of a puncture experiment on a fine needle plate of a first configuration example of the first embodiment using a base with a different tip diameter. 37. A table showing the results of a puncture experiment on a fine needle plate with a base and without a base, in which multiple needles are arranged in a row. 38. A table showing the results of a puncture experiment on a fine needle plate with a base arranged in a row, with the same number of needles but with a different pitch. 39. A graph showing the ratio of the effective puncture area to the coating area of ​​the fine needle plate of Figure 35.

[0013] DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The following describes embodiments of the present invention with reference to the accompanying drawings. In the following drawings, the same components are designated by the same reference numerals, and redundant explanations may be omitted.

[0014] The present invention relates to a microneedle part that can be attached to a skin puncture device. The microneedle part of the present invention applies a cosmetic ingredient as a liquid to the skin of a target. The microneedle part is mainly used for cosmetic and therapeutic purposes by puncturing the skin.

[0015] Although human skin is primarily envisioned as an example of an object to which a liquid is applied by a skin puncture device equipped with a fine needle part of the present invention, the object can also be animal skin, the surface of plant stems, trunks, leaves, etc. Alternatively, the object may be tissue such as skin or organs removed from a subject or test animal, or inorganic materials such as silicone membranes or urethane sheets, but is not limited to these.

[0016] <Application Example 1: Syringe Set> A syringe set in which a fine needle part and a syringe barrel are connected according to one embodiment of the present invention will be described with reference to Figures 1 to 4. First, the overall configuration of the syringe set according to this embodiment will be described with reference to Figures 1 and 2.

[0017] Fig. 1 is an overall cross-sectional view of a syringe set in which a fine needle plate according to one embodiment of the present invention is attached to a syringe barrel together with an attachment frame. Fig. 2 is an exploded view of the syringe set 100 of Fig. 1, showing the syringe 80, the fine needle plate 11 which is the fine needle part 1, and the attachment frame 12.

[0018] 1 and 2, syringe 80 includes a syringe barrel (syringe body, cylinder) 81 and a plunger 85. The syringe barrel 81 contains a liquid content L, and the plunger 85 is inserted into the syringe barrel 81. More specifically, syringe barrel 81 includes an outer cylindrical portion 82 that contains the content L, a flange 83 provided at the rear end of the outer cylindrical portion 82, and a cylindrical tip 84 that is the tip end.

[0019] Here, the syringe 80 to which the microneedle plate 11 of the present invention is attached via the mounting frame 12 can be, for example, a syringe having a volume of 1 mL, 2.5 mL, 5 mL, or 10 mL. Depending on the specific use of the microneedle plate 11, the syringe may have a larger or smaller volume.

[0020] The syringe 80 to which the microneedle part 1 of the present invention is attached is made of glass, metal, or resin, such as polypropylene (PP), polyethylene (PE), acrylonitrile butadiene styrene (ABS), polybutylene terephthalate (PBT), polyacetal (POM), polyethylene terephthalate (PET), polycarbonate (PC), polyether ether ketone (PEEK), and cycloolefin polymer (COP).

[0021] In this embodiment, the microneedle part 1 , which is used in place of a general syringe needle having one hollow needle, is connected to a barrel tip 84 of a syringe barrel 81 .

[0022] More specifically, the mounting frame 12 has a cylindrical mounting tube 126 that fits onto the barrel tip 84 of the syringe barrel 81. When the fine needle plate 11 is attached to the syringe 80, the fine needle plate 11 is first fitted into the mounting frame 12. Then, the barrel tip 84 of the syringe barrel 81 is inserted into and engaged with the fitting hole 127 of the mounting tube 126 of the mounting frame 12. A syringe having a locking structure to prevent the mounting tube 126 of the mounting frame 12 to which the fine needle plate 11 is attached from easily coming off the barrel tip 84 of the syringe barrel 81 may be used. Furthermore, the shape may conform to luer connector standards such as ISO (International Organization for Standardization) and JIS (Japanese Industrial Standards).

[0023] In any of the embodiments, the microneedle part 1 of the present invention has a two-stage needle 112 that protrudes toward the tip side relative to the contact surface of the object.

[0024] In the syringe 80 , when the pushing piece 86 at the rear end is pressed, the plunger 85 moves inside the outer cylindrical portion 82 of the syringe barrel 81 , and the contents L are released from the syringe into the microneedle part 1 .

[0025] When the contents L reach the inside of the fine needle part 1, the contents are sent to the target object such as the skin via the flow path 125 and the outlet hole 116. Furthermore, the contents L enter the target object such as the skin against which the fine needle plate 11 is pressed from the tip of the double needle 112.

[0026] 1, a gasket 87, which is a thin rubber or elastomer packing (sealing element) for preventing liquid leakage and foreign matter from entering, may be adhered to the tip of the plunger 85. It is also possible not to provide a packing.

[0027] Furthermore, in order to protect the multiple double-stage needles 112 of the microneedle part 1 of the present invention, a cap that covers the microneedle part 1 may be attached.

[0028] (Fine needle part according to a first configuration example of the first embodiment) FIG. 3 is a cross-sectional perspective view of a fine needle part including a fine needle plate and an attachment frame of a first configuration example of the first embodiment.

[0029] In this embodiment, the microneedle part 1 is configured as an assembly of two members: a microneedle plate 11 and an attachment frame 12 .

[0030] On the other hand, in the fine needle plate 11, a plurality of two-stage needles 112 and a lip portion 115 are provided on a circular flat plate substrate (plate body) 111. An extraction hole 116 is formed in the center of the plate substrate 111. The plate substrate 111 functions as a plate.

[0031] In the fine needle plate 11, the multiple two-stage needles 112 protrude from the tip surface CF of the plate substrate 111. More specifically, each of the multiple two-stage needles 112 according to this embodiment includes a base portion (base) 113 and a needle portion 114. In this embodiment, the plate substrate 111, which is the plate base (main body), the base portion 113, and the needle portion 114 are integrally formed, and the multiple needle portions 114 protrude from the tip surfaces of the multiple base portions 113, respectively. The two-stage needles 112 according to this embodiment are solid needles with a two-stage shape that do not have holes.

[0032] The lip portion 115 is formed on the outer edge of the front end surface (contact surface) CF of the plate substrate 111. In this embodiment, the lip portion 115 functions as a liquid stopper.

[0033] 3, in the fine needle plate 11, the height (a) of the base portion 113 is preferably 200 μm≦a<3000 μm, and the height (b) of the needle portion 114 is preferably 5 μm≦b<600 μm.

[0034] In this case, it is preferable that the total height (a+b) of the height (b) of the needle portion 114 and the height (a) of the base portion 113 is 600 μm to 3200 μm. In addition, it is preferable that the ratio (b / a) of the height (a) of the base portion 113 to the height (b) of the needle portion 114 is 0.5 or less, and therefore the dimensions are set so as to satisfy this total value and ratio within the recommended ranges of the height (a) of the base portion 113 and the height (b) of the needle portion 114.

[0035] 3, the tip diameter (d) of base 113 is preferably 300 μm≦d≦600 μm, and the diameter of the base of needle 114 is set to be smaller than the tip diameter of base 113. In addition, the edge of the tip surface (top surface) F2 of base 113 is preferably rounded to improve contact with the skin.

[0036] The height of the lip portion 115 from the tip surface CF is equal to or shorter (lower) than the length of the two-stage needle 112. For example, the height of the lip portion 115 is a height at which the liquid spreads over the target object, and is about 10 to 2000 μm.

[0037] In this embodiment, the number of double-tiered needles 112 may be any number, ranging from one to several hundred, and more preferably from several to approximately 100. The multiple double-tiered needles 112 may be arranged regularly or may be provided in random positions. Furthermore, the multiple double-tiered needles 112 on the lower surface may be formed at once from a single sheet (like a pinholder), or may be an assembly in which one or more double-tiered needle assembly units are arranged, each unit having multiple double-tiered needles 112 formed in a row.

[0038] In this embodiment, the needle plate 11 including the double-stage needles 112 is preferably made of a biocompatible material, such as a biodegradable resin, such as polyglycolic acid, polylactic acid, or polyglycolic acid-polylactic acid copolymer, but may also be made of a thermoplastic resin, such as polypropylene (PP), polyethylene (PE), acrylonitrile butadiene styrene (ABS), polybutylene terephthalate (PBT), polyacetal (POM), polyethylene terephthalate (PET), polycarbonate (PC), or polyether ether ketone (PEEK). Biocompatible metal materials, such as stainless steel, cobalt alloy, or titanium alloy, as well as silicone and ceramic, may also be used.

[0039] On the other hand, the mounting frame 12 has a plate support portion 121 and a mounting cylinder 126 .

[0040] In detail, the plate support portion 121 is cylindrical with a top, having a round plate 122 that forms the storage top surface and an outer tube 123 that forms the storage side wall, and the underside forms a recessed storage space, and the outer edge portion of the underside of the round plate 122 that forms the storage top surface, which forms the boundary with the outer tube 123, forms an annular groove 124.

[0041] In assembling the microneedle part 1, the outer periphery of the microneedle plate 11 is fitted inside the outer tube 123 of the mounting frame 12. Then, as shown in Fig. 5(a), in this embodiment, when the microneedle plate 11 is attached to the mounting frame 12, the tip surface LT of the lip portion 115 of the microneedle part 1 protrudes outward (toward the bottom of Fig. 5) from the lower end ST of the outer tube 123. The bottom side of Fig. 5 (left side of Fig. 1) is also referred to as the outside, tip side, or distal end side (relative to the syringe barrel 81) in the axial direction, and the top side of Fig. 5 (right side of Fig. 1) is also referred to as the inside, rear end, or proximal end side in the axial direction.

[0042] Furthermore, a hole is formed in the center of the plate support part 121, and this hole becomes a flow path 125 through which the contents pass in the fine needle part.

[0043] On the other hand, the mounting tube 126 has a cylindrical shape with one end open and the other end connected to the back surface of the plate support part 121, and the inside of the tube is an insertion hole 127. The other end of the mounting tube 126 is formed with a cylindrical perforated bottom surface 128. Note that although the insertion hole 127 is shown as being straight in Figure 3, it may take on various commonly used joint forms such as a tapered shape, a screw type, or a ratchet type.

[0044] 3 shows an example in which the diameters of the central flow paths (holes) are in descending order of size: fitting hole 127 > flow path 125 > dispensing hole 116, but the size of the holes is not important. With this configuration, when attaching the microneedle part 1 to the syringe 80, as the cylindrical tip 84 of the syringe 80 is fitted into the mounting tube 126, the tapered shape of the cylindrical tip 84 gradually narrows at the front relative to the mounting tube 126, ensuring sealing by the fitting of the tapered sides. Note that when the pushing stops due to this narrowing of the taper, the tip 84T of the cylindrical tip 84 may come into contact with the perforated bottom surface 128 between the fitting hole 127 and the flow path 125, as shown in FIG. 2.

[0045] Figure 4 is a bottom view of a first configuration example of a fine needle part of the first embodiment. In the fine needle plate 11 of the first embodiment, the number of two-stage needles 112, which are base-attached needles in which the base 113 and the needle 114 are integrally formed, may be any number, but more preferably, there should be more than one. Furthermore, when multiple base-attached needles are provided, it is preferable that they are arranged in a regular pattern. Figure 4 shows an example in which the vertices of the needles 114 are arranged in a diagonal lattice pattern (triangular array) when viewed from the bottom of the fine needle plate 11, but the vertices of the needles 114 may also be arranged in a lattice pattern (square array).

[0046] Also, as shown in Figures 3 and 4, when multiple two-stage needles 112, which are needle portions with bases each consisting of a base and a needle portion, are arranged to protrude from the plate substrate 111, it is preferable that adjacent bases 113 are arranged at a distance from each other and that the pitch (c) between the vertices of the needle portions 114 is 1 mm ≦ c < 5 mm.

[0047] It is preferable that the ratio ((a+b) / c) of the sum of the height (a) of the base 113 and the height (b) of the needles 114 to the pitch (c) of the needles 114 is 0.3 or more and 1.1 or less. This makes the distance (e) between the edges of the tip surfaces F2 of the bases 113 0.5 mm or more and 4.4 mm or less.

[0048] In addition, the number of pedestals 113 per unit area on the plate substrate 111 is 0.1 / cm ２ More than 33 pieces / cm ２ The following is preferable: The dimensions and effects of each of these components will be described in detail below along with the results of experimental examples shown in FIGS.

[0049] FIG. 5 is a cross-sectional view showing the puncture of the target O by the fine needle part and the flow of liquid in the first embodiment.

[0050] By pressing the syringe barrel 81 of the syringe 80 against the target O such as the skin, the base portions 113 of the multiple double-stage needles 112 spread the target O and puncture the needle portions 114 (see FIG. 5( a)). At this time, the lip portions 115 on the outer edge of the contact surface CF of the fine needle part 1 come into contact with the target O.

[0051] Thereafter, when the plunger 85 of the syringe 80 is pressed, the liquid L stored in the syringe 80 flows into the fine needle part 1, and the liquid spreads in the space formed between the object O, the lip portion 115, and the tip surface CF of the plate substrate 111, and also enters the skin through the holes opened by the multiple two-stage needles 112. In other words, the liquid penetrates through the gap between the surface on the tip side of the base portion 113 of the two-stage needle 112 and the skin (see FIG. 5(b)).

[0052] After the injection, the fine needle part 1 is kept pressed against the object O via the syringe for a predetermined time (less than 1 second to about 30 minutes, preferably about several seconds to several minutes).

[0053] After a predetermined time has elapsed, the syringe 80 is removed from the object O, thereby pulling out the needle portion 114 of the two-stage needle 112 from the object O.

[0054] As described above, in the present invention, a liquid having a cosmetic effect on the skin (the object O) is spread radially inward of the lip portion 33, and the base portion 113 of the two-stage needle 112 spreads the skin to make it easier to pierce, allowing the liquid to penetrate into the object O through the hole made by the punctured needle portion 114. Therefore, the active ingredients contained in the liquid can penetrate both the outside (surface side) and the inside (through the puncture hole) of the object O. For example, if the object O is skin, the cosmetic ingredients contained in the liquid can penetrate both the outside and the inside of the skin.

[0055] <Second Configuration Example of the Microneedle Part of the First Embodiment> Next, a second configuration example of the microneedle part will be described with reference to Fig. 6. Fig. 6 is a diagram showing a microneedle part 1A according to the second configuration example of the first embodiment of the present invention.

[0056] The above-mentioned fine needle part 1 has an assembly structure (assembly structure) consisting of two components, the mounting frame 12 and the fine needle plate 11, but the fine needle part may have an integrated function of mounting to the nozzle of the syringe and a puncturing function.

[0057] In this embodiment, the microneedle part 1A integrally comprises a microneedle plate 131 and an attachment tube 136.

[0058] The integrated microneedle part 1A according to this embodiment is preferably made of a biocompatible material, such as a biodegradable resin, such as polyglycolic acid, polylactic acid, or polyglycolic acid-polylactic acid copolymer, but may also be made of a thermoplastic resin, such as polypropylene (PP), polyethylene (PE), acrylonitrile butadiene styrene (ABS), polybutylene terephthalate (PBT), polyacetal (POM), polyethylene terephthalate (PET), polycarbonate (PC), polyether ether ketone (PEEK), etc. Biocompatible metal materials, such as stainless steel, cobalt alloy, or titanium alloy, as well as silicone and ceramics, may also be used.

[0059] The microneedle plate 131, which is a circular, flat plate substrate, is provided with a plurality of two-stage needles 132 each having a base portion 133 and a needle portion 134, and a lip portion 135. An extraction hole 139 is formed in the center of the microneedle plate 131.

[0060] The height of the lip portion 135 from the tip surface CF is configured to be lower (shorter) than the height of the two-step needle 132 .

[0061] The mounting tube 136 has a fitting hole 137 formed therein. In this configuration, the portion sandwiched between the radially inner side of the fitting hole 137 and the radially outer side of the discharge hole 139 forms a cylindrical perforated bottom surface 138. When the mounting tube 136 engages with the cylindrical tip 84 of the syringe 80, the content L coming out of the flow path of the cylindrical tip 84 collides with and passes through the perforated bottom surface 138. The perforated bottom surface 138 may be tapered or curved toward the discharge hole 139, which is a through hole, to allow the liquid to move smoothly. Alternatively, the perforated bottom surface 138 may have a screw structure or a ratchet structure.

[0062] In this embodiment, too, the lip portion 135 is integrally formed with the underside of the fine needle plate 131, and the two-stage needles 132 are provided, so that the liquid effective for the target object is spread radially inward of the lip portion 135 onto the skin, and the base portion 133 stretches the skin, allowing the needles 134 to penetrate more easily, creating holes that allow the liquid to penetrate into the target object. This allows the active ingredients contained in the liquid to penetrate both the outside and inside of the target object. For example, if the target object is skin, the cosmetic ingredients contained in the liquid can penetrate both the outside and inside of the skin.

[0063] <Third Configuration Example of the Fine Needle Part of the First Embodiment> In the above, an example in which the needle plate has one dispensing hole in the center has been described, but the number of dispensing holes does not have to be one, and the hole does not have to be in the center.

[0064] 7 is a cross-sectional perspective view of a microneedle part 1A according to a third configuration example of the first embodiment. In this configuration example, the microneedle plate 11B has multiple outlet holes 116a-116d that penetrate vertically, rather than being located at the center. Therefore, liquid flowing in from the flow path 125 of the mounting cylinder 126 must be transferred to the outlet holes 116-116d that are located away from the center. Therefore, a gap is provided between the mounting frame 12B and the plate substrate 111B of the microneedle plate 11B to allow the liquid to pass through.

[0065] To achieve this gap, in this embodiment, an annular protrusion 129 is provided at a fixed distance from the center on the tip surface of the round plate 122B of the plate support portion 121B of the mounting frame 12B. When the fine needle plate 11B is attached to the mounting frame 12B, the tip of the annular protrusion 129 abuts against the back surface BF of the plate substrate 111B, creating a partitioned gap space between the annular protrusion 129 and the rear end side surface of the plate substrate 111B. When liquid enters this gap space from the flow path 125 of the mounting frame 12B, it forms a pool, from which the liquid can flow to the discharge holes 116a-116d.

[0066] Therefore, in this embodiment, the positions of the extraction holes 116a to 116d provided in the plate substrate 111B that functions as a plate are set so that their distance from the center is closer than their position from the center of the annular protrusion 129 of the mounting frame 12B.

[0067] In the microneedle part 1B of this embodiment, the liquid flowing from the mounting tube 126 passes through the flow path 125 in the center of the perforated bottom surface 128, spreads as a puddle in the gap space on the upper surface of the plate substrate 111B, and then enters the multiple injection holes 116a to 116d.

[0068] When the liquid that has entered the multiple discharge holes 116a to 116d is pushed out of the tip surface CF of the plate substrate 111B, the liquid spreads over the object on the inner circumferential side of the lip portion 115, as described above, and the base portion 113 of the two-stage needle 112 spreads the skin to make it easier to pierce, allowing the liquid to penetrate into the object O through the hole made by the punctured needle portion 114. Therefore, the active ingredient contained in the liquid can penetrate into the object from both the outside and the inside.

[0069] In this embodiment, the plurality of outlet holes 116a to 116d away from the center and the gap spaces form two-stage liquid pools on the back surface and the front end surface of the plate substrate 111B, which makes it easy for the liquid to spread radially outward. Therefore, even when the object has an uneven surface or protrusions on the surface that make it difficult for the liquid to spread from the center to the lip portion 115 on the outer periphery, the presence of outlet holes 116a to 116d at positions halfway from the center to the lip portion 115 makes it possible to more fully spread the liquid radially outward from the center.

[0070] The number of the ejection holes 116a to 116d is a plural number of 2 or more. In this configuration, the greater the number of ejection holes, the greater the effect of spreading outward in the radial direction from the center.

[0071] Furthermore, in this configuration example, in order to more efficiently move liquid from the center radially outward in the gap space between the plate substrate 111B and the round plate 122B of the mounting frame 12B, a band-shaped recess may be formed on the rear end side of the plate substrate 111B, with the shortest path for liquid to flow from the center to the injection holes 116a to 116d as a flow path.

[0072] <Fourth Configuration Example of the Microneedle Assembly of the First Embodiment> Figure 8 is a cross-sectional perspective view of a fourth configuration example of the microneedle assembly of the first embodiment. In this configuration example, the microneedle plate 11C does not have a vertically penetrating outlet hole, and the microneedle plate 11C is smaller than the inner edge of the outer tube 123C of the mounting frame 12C. Furthermore, the radially inner portion of the outer tube 123C of the mounting frame 12C forms a lip portion 123L that protrudes toward the tip. Therefore, the groove between the radially outer side of the outer edge of the plate substrate 111C and the lip portion 123L of the mounting frame 12C forms an annular flow path Gc through which liquid can flow in a circular pattern.

[0073] Also, in this configuration example, as in the third configuration example, it is necessary to move the liquid flowing in from the flow path 125 of the mounting tube 126 to the annular flow path Gc away from the center, so the annular protrusion 129 is provided to provide a gap space Sc through which the liquid can pass between the mounting frame 12C and the plate substrate 111C of the microneedle plate 11C. The configuration of the gap is the same as in the third configuration example.

[0074] In the microneedle part 1C of this embodiment, the liquid flowing from the mounting tube 126 passes through the central flow path 125 of the perforated bottom surface 128, spreads as a puddle in the gap space Sc on the upper surface of the plate substrate 111C, and then flows into the outer annular gap Gc.

[0075] When the liquid that has flowed into the outer annular gap Gc in the radial direction reaches the object, the liquid spreads from the lip portion 123L provided on the mounting frame 12C toward the center of the circle, and the base portion 113 of the two-stage needle 112 spreads the skin to make it easier to pierce, allowing the liquid to penetrate into the object O through the hole made by the piercing needle portion 114. Therefore, the active ingredient contained in the liquid can penetrate into the object O from both the outside and the inside.

[0076] <Fifth Configuration Example of the Microneedle Part of the First Embodiment> FIG. 9 is a cross-sectional perspective view of a microneedle part 1D according to a fifth configuration example of the first embodiment.

[0077] In this configuration example, a shaft 117 that is inserted into hole 127D is provided on the back side of needle plate 11, and a sealing valve 118 is provided at the free end of the shaft. In addition, a slightly larger movable space 127M is formed at the lower end of fitting hole 127D inside mounting tube 126 of mounting frame 12D, allowing sealing valve 118 to move.

[0078] With this configuration, in this example, the fine needle plate 11D can be raised and lowered by pressing against the mounting frame 12D. In a steady state in which no force is applied and the fine needle plate 11D is facing downward, the rear end surface of the fine needle plate 11D is spaced apart from the tip surface of the round plate 122D of the mounting frame 12D.

[0079] In this configuration, in addition to the liquid being conducted by pressing with the plunger as described above, when the fine needle plate comes into contact with the skin and is pushed up, the liquid is conducted by the sealing valve 118. Alternatively, instead of pressing with the plunger, the liquid may be opened or closed by the sealing valve 118 alone.

[0080] Details of the operation in this configuration example will be described with reference to Fig. 10. Fig. 10 is a diagram for explaining the operation of the fine needle part 1 according to the fifth configuration example with respect to the target O.

[0081] By pressing the syringe barrel 81 of the syringe 80 against the target O such as the skin, the base 113 of the double needle 112 deforms and spreads the skin to make it easier to insert the needle, and the target O is punctured by the needle part 114 (see FIG. 10(a)). At the same time, the double needle 112 on the tip side of the fine needle part 1D comes into contact with the skin, causing the fine needle plate 11D to be pushed back by the skin.

[0082] Then, as the plunger 85 of the syringe 80 is pressed and the fine needle plate 11D is pushed in, the rear end surface of the plate substrate 111D approaches the tip surface of the round plate 122D of the mounting frame 12D, opening the sealing valve 118 in the mounting tube 26D, and the liquid L stored in the syringe 80 flows into the fine needle part 1D, through the gap space Sd, and into the annular flow path Gd. The liquid spreads in the space formed between the object O, the lip portion 123L, and the tip surface CF of the plate substrate 111D, and the base portion 113 of the double needle 112 spreads the skin, making it easier to pierce, and the liquid enters the skin through the hole made by the punctured needle portion 114, i.e., it penetrates at least through the gap between the tip surface of the base portion 113 and the skin (see FIG. 10(b)).

[0083] <First configuration example of the microneedle part of the second embodiment> In the first embodiment described above, in the microneedle part, the base part and the needle part were integrally formed on the outermost (tip side) microneedle plate, but in the two-stage needle of the microneedle part of the present invention, the base part and the needle part may be formed by separate plates.

[0084] Therefore, a second embodiment of the microneedle part in which the base and needle are configured as separate plates will be described with reference to Figures 11 and 12. Figure 11 is an enlarged perspective cross-sectional view of a microneedle part 2 of a first configuration example of the second embodiment of the present invention. Figure 12 is a diagram showing a state in which a liquid is being injected into a target object from the microneedle part 2 of the second embodiment of the present invention.

[0085] The mounting frame 22 of the microneedle part 2 of this embodiment has, as described above, a plate support part 221 and a mounting cylinder 226. The plate support part 221 is cylindrical with a top, and includes a circular flow channel microneedle plate 222 that forms the top surface of the housing, and an outer cylinder 223 that forms the side wall of the housing, with the bottom surface forming a recessed housing space. In addition, the outer edge of the flow channel microneedle plate 222 that forms the top surface of the housing is provided with an annular protrusion 224.

[0086] However, in the mounting frame 22 of this configuration, needle-like protrusions (also called solid needles) 229 are provided on the flow path fine needle plate 222 on the back side where the flow path holes 225 are formed. Also, in place of a base portion, the outer (tip side) abutment plate 21 is provided with a tubular portion 216 having a hollow 217 through which the needle-like protrusions 229 can be inserted. Therefore, the fine needle part 2 of this configuration example comprises the mounting frame 22 including the flow path fine needle plate 222 having the flow path holes 25 and the needle-like protrusions 229, and the abutment plate 21 having the tubular portion 216.

[0087] As shown in Figure 11, in the mounting frame 22, one or more conical needle-like protrusions 29 protrude (hang down) from the outer surface (bottom surface) F5 of the flow path fine needle plate 222, which has a flow path hole 25 formed in the center.

[0088] On the other hand, the abutment plate 21 has one or more tubular portions 216 protruding (hanging down) from the abutment surface (first surface, lower surface) F10 facing the object of the outer plate substrate 211, which is arranged opposite the outside (tip side) of the flow path fine needle plate 222.

[0089] In this case, the same number of cylindrical portions 216 as the number of needle-like protrusions 229 are arranged so that the needle-like protrusions 229 protruding from the flow path fine needle plate 222 are positioned radially inside the cylindrical portions 216 of the abutment plate 21. In this embodiment, the cylindrical portions 216 serve as base portions, and the portions of the needle-like protrusions 229 protruding from the cylindrical portions 216 serve as needle portions, so that the cylindrical portions 216 and the needle-like protrusions 229 form a two-stage needle.

[0090] 12 , the liquid that has passed through the flow path hole 25 spreads as a pool in the space S4 between the lower surface F5 of the flow path fine needle plate 222 and the upper surface F4 of the outer plate substrate 211. Then, in the hollow 217 of the tubular portion 216, the liquid enters and flows into the cylindrical gap between the outer surface of the needle-like protrusions 229 and the inner circumferential surface of the tubular portion 216, and enters the interior of the object O through the holes opened by the needle-like protrusions 229.

[0091] 11 and 12 show an example in which the upper surface F4 of the outer plate substrate 211 and the lower surface F5 of the flow channel microneedle plate 222 are both flat, but as shown in Fig. 14 described below, radial grooves may be provided on the upper surface of the outer plate substrate 211 to form the conductive paths. Alternatively, the upper surface F4 of the outer plate substrate 211 and the lower surface F5 of the flow channel microneedle plate 222 may be brought into contact with each other, and radial grooves may be provided on the lower surface F5 of the flow channel microneedle plate 222 to form the conductive paths.

[0092] Alternatively, in the gap formed by arranging the entire upper surface F4 of the outer plate substrate 211 and the entire lower surface F5 of the flow path microneedle plate 222 in close proximity without contact, a conductive path may be formed by providing a filler in an area other than the area that is the shortest path for liquid to flow from the center to the hollow 217 of the tubular portion 216.

[0093] 12, the liquid spreads over the object O along the inner peripheral side of the tip edge F20 of the tubular portion 216, and also penetrates into the object O through the holes formed by the needle-like projections 229. Therefore, the active ingredients contained in the liquid can penetrate into the object O from both the outside and the inside.

[0094] 12 , a liquid having an effective effect on a target object is spread radially inward from the distal end edge F20 of the cylindrical portion 216 while the skin is deformed and expanded by the cylindrical portion 216, and the liquid is also allowed to penetrate into the target object through holes formed by the solid needle-like protrusions 229. Therefore, the active ingredients (e.g., cosmetic ingredients) contained in the liquid can penetrate both the outer surface of the target object and the inner surface of the target object. For example, when applying the second embodiment, the syringe 80 can be opened or the liquid can be poured into the syringe barrel 81 immediately before use, and then a small fine needle part can be attached to the syringe to inject the liquid, thereby providing fresh cosmetic ingredients on and within the skin.

[0095] At this time, as shown in Figure 12, because the gap between the object and the tip edge F20 of the tubular portion 216 is narrow, the liquid spreads throughout the entire area surrounded by the tip edge F20 of the tubular portion 216. Specifically, in the space surrounded by the skin and the tip edge F20 of the tubular portion 216, the liquid may initially pool downward, but as the space fills with liquid, it will eventually spread upward. In this way, the tip edge F20 of the tubular portion 216 prevents leakage from the gap, allowing the active ingredient to be retained on and inside the object. This allows the microneedle part 2 to deliver the liquid active ingredient to and inside the surface of the object, even when the syringe 80 is facing up or sideways.

[0096] 11 and 12, in this embodiment, the tip of the needle-like projection 229 is located outside (lower, more distal end side) than the tip edge F20 of the cylindrical portion 216, thereby forming a two-stage needle by the needle-like projection 229 and the cylindrical portion 216. Therefore, in this configuration, it is preferable that the height of the cylindrical portion 216 is not less than 200 μm and less than 3000 μm, and the height of the needle-like projection 229 outside the abutment surface F10 is 600 μm to 3200 μm.

[0097] Also in this configuration, it is preferable that the outer diameter of the tip edge F20 of the cylindrical portion 216, which corresponds to the base portion of the double needle, is greater than 200 μm and not greater than 600 μm.

[0098] 11 and 12 , the multiple cylindrical portions 216 and the multiple needle-like projections 229 are spaced apart from one another, and it is preferable that the pitch between the apexes of the needle-like projections 229 located inside the cylindrical portions 216 in the assembled state be 1 mm or more and less than 5 mm. In this case, it is preferable that the distance between the edges of the top surfaces of the cylindrical portions 216 (the outer edges of the leading edge F20) be 0.5 mm or more and 4.4 mm or less.

[0099] In addition, the number of the cylindrical portions 216 per unit area on the outer plate substrate 211 is 0.1 / cm ２ Above, 33 pieces / cm ２ The following is preferable:

[0100] 11, the example of the microneedle part according to this embodiment is configured with two members, the attachment frame 22 including the flow path microneedle plate (flow path plate) 222, and the abutment plate 21. However, the flow path microneedle plate does not have to be integrated with the attachment frame. For example, the flow path microneedle plate 222 may be mounted so as to face the abutment plate 21 using a separate member that holds the two plates at a predetermined distance (for example, a holding member that holds the outer edges, or an adhesive member that bonds the two plates at a predetermined thickness).

[0101] <Second Configuration Example of Second Embodiment> Various modifications in which the height is partially changed can be made to the second embodiment shown in Fig. 11. Fig. 13 is a cross-sectional view of a microneedle part 2A according to a second configuration example of the second embodiment.

[0102] 13, in this configuration example, multiple needle sets NS are provided, each consisting of multiple needle-like protrusions 229 and a cylindrical portion 216, protruding from the outer plate substrate 211 of the abutment plate 21A. Among the multiple needle sets NS, there are needle sets NSA in which the protrusion lengths from the outer plate substrate 211, i.e., the heights of both the needle-like protrusions 229 and the cylindrical portion 216, are different. In other words, the length of the entire needle set NS, which is made up of two needles, is partially changed.

[0103] In this configuration example, it is possible to puncture to various depths with a single puncture. When changing the length of the needle set, it is preferable to set it so that it is shorter near the center and longer near the outer edge in the radial direction. When changing the length of the needle set NS partially, it is preferable that the rate of change be within ±15% of the other needle sets.

[0104] <Third Configuration Example of Second Embodiment> Fig. 14 is a cross-sectional view of a fine needle part 2B according to a third configuration example of the second embodiment. As shown in Fig. 14, in this configuration example, in a plurality of needle sets NS, the protruding height of the needle-like protrusions 229 from the flow channel fine needle plate 222 is the same, but in a plurality of tubular portions 216, some of the tubular portions 216 have different protruding heights from the outer plate substrate 211. In other words, the height of the tubular portion 216 that serves as the base of the double needle is partially changed.

[0105] In this configuration example, it is possible to puncture to various depths with a single puncture. When changing the length of the tubular portion of the needle set, it is preferable to set it so that it is shorter near the center and longer near the outer edge in the radial direction. When changing the length of the tubular portion of needle set NS partially, it is preferable that the change rate be ±15% or less compared to the tubular portions of other needle sets.

[0106] <Fourth Configuration Example of Second Embodiment> Fig. 15 is a cross-sectional view of a fine needle part 2C according to a fourth configuration example of the second embodiment. As shown in Fig. 15, in this configuration example, in a plurality of needle sets, the protruding height of the cylindrical portion 216 from the outer plate substrate 211 is the same, but among the plurality of needle-like protrusions 229, some of the needle-like protrusions 229 protrude to different heights from the flow channel fine needle plate 222. In other words, among the double needles, the heights of the needles protruding from the same height base portion are changed.

[0107] In this configuration example, it is possible to puncture to various depths with a single puncture. When changing the length of the tubular portion of the needle set, it is preferable to set it so that it is shorter near the center and longer near the outer edge in the radial direction. Furthermore, when changing the length of the needle-like protrusions in the needle set NS partially, it is preferable that the rate of change be within ±15% compared to the tubular protrusions of other needle sets.

[0108] In the configuration examples shown in Figures 13 to 15, the length of the needle set varies in Figure 13, the length of the tubular portion varies in Figure 14, and the length of the needle-like protrusions varies in Figure 15. Here, heights a16, a16A, a16B, and a16C from the outer plate substrate 211 to the tip surfaces of the tubular portions 216, 216A, and 216B are all 200 μm or more and less than 3000 μm. Furthermore, the protruding heights (differential heights) b29, b29A, b29B, and b29C of the needle-like protrusions 229, 229A, and 229C from the tip surfaces of the tubular portions 216 (216A and 216B), respectively, are less than the heights a16, a16A, a16B, and a16C of the tubular portion 216, and are preferably 5 μm to 700 μm, more preferably 10 μm to 200 μm.

[0109] In any of the configuration examples, the multiple sets NS are spaced apart from one another, and it is preferable that the pitch c29 between the apexes of the needle-like projections 229 (229A, 229C) is 1 mm≦c29<5 mm.

[0110] In this configuration, it is preferable that the outer diameter d16 (d16A, d16B) of the tip surface of the cylindrical portion 216 (216A, 216B) is greater than 200 μm and not greater than 600 μm.

[0111] Taking into consideration deformation of the skin, it is preferable that the ratio ((a16 + b29) / c29) of the sum of the height a16 of the tubular portion 216 and the differential height b29 of the acicular projections 229 to the pitch c29 of the acicular projections 229 be 0.3 or greater and 1.1 or less. In this case, it is preferable that the spacing e16 of the outer edges of the tubular portion 216 be less than the pitch c29 and be 0.5 mm or greater and 4.4 mm or less.

[0112] By keeping the dimensions within the above ranges, even if the length of the needle set, the length of the tubular portion, or the length of the needle changes partially, the skin is deformed and spread open by the tubular portion 216, and a liquid that is effective on the target object can be spread radially inward from the tip edge of the tubular portion 216 onto the skin, and can also penetrate into the inside of the target object through holes made by the needle-like protrusions 229, which are solid needles.

[0113] However, depending on the condition of the subject (for example, if the skin is hard), for example, if the differential height b29A is shorter than the other needle-like protrusions, as in the case of needle-like protrusions 229A of needle set NSA in Fig. 13, the needle-like protrusions may not puncture the subject. In this case, the liquid that is effective on the subject is spread over the skin radially inward from the tip edge of tubular portion 216 while deforming and spreading the skin, allowing it to penetrate only from the outside of the subject.

[0114] <Third embodiment> In the first embodiment described above, in the fine needle part 1, the two-stage needle, base part, and needle part are integrally formed on the plate substrate 111 of the outermost fine needle plate 11, and the dispensing hole 116 is formed in a location on the plate substrate 111 separate from the two-stage needle. However, in the fine needle part of the present invention, a hole through which liquid passes may be formed in the base part.

[0115] Therefore, a third embodiment in which a hole is formed in the base will be described with reference to Figures 16 and 17. Figure 16 is a cross-sectional perspective view of a fine needle part 4 according to the third embodiment of the present invention. Figure 17 is a diagram showing a state in which a liquid is being injected into a target object from the fine needle part 4 according to the third embodiment.

[0116] The fine needle part 4 of this embodiment has a fine needle plate 41 and a mounting frame 42. The mounting frame 42 has the same configuration as the mounting frame 12B shown in FIG.

[0117] In the fine needle plate 41, a plurality of lipped double-step needles 412 protrude from the tip surface F11 of the plate substrate 411. In each of the plurality of lipped double-step needles 412, the base portion 413 and the needle portion 414 are integrally formed with the plate substrate 411.

[0118] The outer edge of the distal end surface (top surface) of each base 413 is longer than the distal end concave surface F13, which is the radially central distal end surface, and is positioned outward (distal end side) from the radial center, forming an individual lip 415. That is, the radial center of the distal end surface of each base 413 is recessed toward the proximal end.

[0119] Furthermore, as shown in Figures 16 and 17, in the portion of the tip concave surface F13 of the base portion 413 where the needle portion 414 is not formed, one or more injection holes 416 through which the fluid passes are formed so as to penetrate the plate substrate 411 and the base portion 413 in the vertical direction.

[0120] Furthermore, in each lipped two-stage needle 412, the length of the needle portion 414 protruding from the tip concave surface F13 is longer than the length of the individual lip 415, which is the outer edge portion, protruding from the tip concave surface F13. Therefore, the individual lip 415 functions as a liquid stopper in each lipped two-stage needle 412.

[0121] In addition, the round plate 422 of the mounting frame 42 has a ring-shaped protrusion 429, similar to the round plate 122B in Figure 7, which creates a gap between the round plate 422 of the mounting frame 42 and the plate substrate 411 of the microneedle plate 41 through which liquid can pass.

[0122] When the fine needle plate 41 is attached to the mounting frame 42, the tip of the annular protrusion 429 abuts against the back surface of the plate substrate 411, and the area surrounded by the tip surface F25 of the round plate 422, the annular protrusion 429, and the back surface F24 of the plate substrate 411 forms a partitioned gap space SF. When liquid enters this gap space SF from the flow path 425 of the mounting frame 42, it forms a pool, from which the liquid spreads radially outward and flows into the spout hole 416.

[0123] 17, the liquid that has entered the plurality of dispensing holes 416 is forced out of the tip concave surface F13 through the plate substrate 411 and the base portion 413. The forced-out liquid spreads in the space formed between the object, the individual lip 415, and the tip concave surface F13 of the base portion 413, and also enters the inside of the object through the holes opened by the needle portion 414. Therefore, the active ingredient contained in the liquid can permeate the object O from both the outside and the inside.

[0124] For example, a liquid having an effective effect on the target object is spread over the skin by the recessed portion at the tip of the base portion 413 while the skin is deformed and spread by the tip surface F15 of the individual lip 415, and is also allowed to penetrate into the target object through holes made by the solid needle portion 414. Therefore, the active ingredients (e.g., cosmetic ingredients) contained in the liquid can penetrate both the outside of the target object surface and the inside of the target object.

[0125] At this time, as shown in Figure 17, because the gap between the object and the tip surface F15 of the individual lip 415 is narrow, the liquid spreads throughout the entire recess at the tip of the base 413, which is the area surrounded by the tip surface F15 of the individual lip 415. Specifically, when injecting in the orientation shown in Figure 17, the liquid may initially pool downward in the space surrounded by the skin and the recess at the tip of the base 413, but as the space fills with liquid, it eventually spreads upward. In this way, the tip surface F15 of the individual lip 415 prevents leakage from the gap, allowing the active ingredient to be retained on and inside the object. This allows the microneedle part 4 to deliver the liquid active ingredient to and inside the surface of the object, even when the syringe 80 is facing up or sideways.

[0126] Here, in this embodiment, the height a15 from the plate substrate 411 to the tip surface F15, which is the height near the outer edge of the base portion 413, is preferably 200 μm or more and less than 3000 μm, and the protruding height (differential height) b14 of the needle portion 414 from the tip surface F15 is preferably 10 μm to 200 μm.

[0127] As shown in FIGS. 16 and 17, the plurality of lipped two-stage needles 412 are spaced apart from one another, and it is preferable that the pitch c14 between the apexes of the needle portions 414 is 1 mm≦c14<5 mm.

[0128] In this configuration, it is also preferable that the outer diameter of the tip edge F15 of the individual lip 415 formed integrally with the base portion 413 is greater than 200 μm and not greater than 600 μm.

[0129] Taking into consideration deformation of the skin, it is preferable that the ratio ((a15 + b14) / c14) of the sum of the outer edge height (a15) of the base 413 and the differential height (b14) of the needles 414 to the pitch (c14) of the needles 414 be 0.3 or more and 1.1 or less. In this case, it is preferable that the distance between the edges of the tip surfaces F15 of the individual lips 415, which are the outer edges of the base 413, be 0.5 mm or more and 4.4 mm or less.

[0130] In addition, the number of lipped double-step needles 412 per unit area on the plate substrate 411 is 0.1 / cm ２ Above, 33 pieces / cm２ The following is preferable:

[0131] 16 illustrates an example in which the fine needle plate 41 provided with the lipped two-stage needle 412 is separate from the mounting frame 42 provided with the mounting cylinder 426 and the flow path 425, and the fine needle part 4 is an assembled body. However, the fine needle part having the lipped two-stage needle 412 of this embodiment may be integrated with the function of attaching to the syringe barrel tip and the function of puncturing, as in the fine needle part 1A of FIG. 6. In this integrated fine needle part of this embodiment, there is no plate support part 421, a flow path is formed in the radial center of the fine needle plate 41, and a mounting cylinder is integrally provided on the rear end side.

[0132] Furthermore, in this embodiment, since the needle portion protrudes from the tip of the base portion, the shape of the needle portion of all or some of the multiple lipped two-stage needles 412 may be changed.

[0133] <Modification 1 of Needle Portion of Third Embodiment> Fig. 18 is an explanatory diagram of Modification 1 of the needle portion of the lipped two-stage needle of the third embodiment. In Fig. 18, (a) is a perspective view and (b) is a bottom view of a lipped two-stage needle 412A.

[0134] In this configuration, as shown in FIG. 18, in each lipped two-stage needle 412A, the needle portion 414A formed on the tip concave surface F13 of the base portion 413 has a shape in which two semi-cones (half-truncated cones) HC1 and HC2 of different diameters face each other so that their vertices TA coincide.

[0135] In this configuration, the cut surfaces of the semi-cones HC1 and HC2 face each other, and a portion of the cut surface CA of the larger-diameter semi-cone HC2 is exposed. This allows the needle 414A to have a larger surface area than the simple conical needle 414 shown in FIG. 16 . This increases the surface area of ​​the side of the puncture hole in the target object punctured by the needle 414A, making it easier for the contents to penetrate into the skin. This allows for the penetration of liquid through the hole in the target object created by the puncture. Therefore, when using the needle 414A to puncture, the time required for liquid penetration during puncture can be shortened and the amount of liquid that penetrates into the target object can be increased compared to the configuration shown in FIG. 16 .

[0136] In this configuration example, the diameter of the smaller semi-cone is preferably about 20 to 70% of the diameter of the larger semi-cone. For example, the radius of the base of the smaller semi-cone is preferably 30 to 100 μm.

[0137] <Modification 2 of Needle Portion of Third Embodiment> Fig. 19 is an explanatory diagram of Modification 2 of the needle of the needle portion of the lipped two-stage needle of the third embodiment. In Fig. 19, (a) is a perspective view and (b) is a bottom view of a lipped two-stage needle 412B.

[0138] 19, in each lipped two-stage needle 412B, the needle portion 414B formed on the tip concave surface F13 of the base portion 413 has a shape in which half right circular cones (semi-right circular cones) HC3 and HC4 face each other but are offset in the cross-sectional direction. In this configuration, the central axes of the two opposing half right circular cones HC3 and HC4 are offset in the cross-sectional direction, so the positions of the vertices T3 and T4 of the semi-right circular cones do not coincide and are spaced apart.

[0139] Therefore, in this configuration example, because needle portion 414B has two vertices T3 and T4, when a single lipped two-stage needle 412B punctures the target object, two holes are formed in close proximity to each other. This increases the number of starting points for fluid penetration. Furthermore, in this configuration, because portions of cut surfaces C3 and C4 are exposed at the opposing surfaces of the offset half right circular cones HC3 and HC4, needle portion 414B has a larger surface area than the simple conical needle portion 414 in FIG. 16, making it easier for the contents to penetrate into the skin.

[0140] In this configuration example, the diameters of the two opposing half right circular cones HC3 and HC4 may be the same or different, but if they are different, it is preferable that the radius of the base of the smaller half right circular cone be approximately 60 to 99% so that the smaller half right circular cone extends from only one radial direction in the cross section of the larger half cone. For example, it is preferable that the radius of the base of the smaller or equal-sized half cone be 50 to 100 μm.

[0141] <Modification 3 of Needle Portion of Third Embodiment> Figure 20 is an explanatory diagram of Modification 3 of the needle portion of the lipped two-stage needle of the third embodiment. In Figure 20, (a) is a perspective view and (b) is a bottom view of a lipped two-stage needle 412B.

[0142] In each lipped two-stage needle 412C of this example, as shown in Figure 20, the needle portion 414C protruding from the tip concave surface 13F of the base portion 413 is such that when a line is drawn from the center of the base of each cone to the apex, the line is not perpendicular, and the two oblique semi-cones HC5 and HC6 are offset in the cross-sectional direction and face each other so that the positions of their apexes TC coincide.

[0143] In this configuration, the cut surfaces of the half oblique cones HC5 and HC6 face each other, and portions of the cut surfaces C5 and C6 of the half oblique cones HC5 and HC6 are exposed, so needle portion 414A has a larger surface area than the simple conical needle portion 414 shown in Figure 16. This makes it easier for the contents to penetrate into the skin. Furthermore, because the apexes are aligned, when puncturing, the surface area inside each hole in the target object is increased, and the number of holes is not increased.

[0144] In this configuration example, the diameters of the two opposing oblique semi-cones HC5 and HC6 may be the same or different, but if they are different, it is preferable that the radius of the smaller semi-cone be approximately 60 to 99% so that it extends from only one radial direction in the cross section of the larger semi-cone. For example, it is preferable that the radius of the base of the smaller or equal-sized oblique semi-cone be 50 to 100 μm.

[0145] <Fourth embodiment of the microneedle plate> In the first to third embodiments described above, examples were described in which the needle portion of the double needle was a solid needle, but in the microneedle part of the present invention, the double needle may be a hollow needle.

[0146] 21 is an enlarged cross-sectional view of a fine needle plate and an attachment frame according to the fourth embodiment. The fine needle assembly of this embodiment has an attachment frame 32 including a flow channel plate 322, and a fine needle plate 31.

[0147] As shown in FIG. 21 , the fine needle plate 31 of this embodiment includes a plate substrate 311 and multiple two-stage needles 312 protruding from the tip side of the plate substrate 311. The two-stage needles include multiple bases (pedestals) 313 and multiple needles 314. In this embodiment, the plate substrate 311, which is the plate base (main body), the bases 313, and the needles 314 are integrally formed, and the multiple needles 314 protrude from the tip surfaces of the multiple bases 313. In addition, an extraction hole 315 (see FIG. 21 ), through which a fluid passes, is formed extending in the protruding direction of the needles 314 and penetrating vertically through the needles 314, the base 313, and the plate substrate 311. That is, the two-stage needles 312 of this embodiment are two-stage hollow needles with through-holes in the bases 313 and the needles 314.

[0148] The configuration of the mounting frame 32 is similar to that of the mounting frame 12 of the first embodiment.

[0149] In this embodiment, the fine needle plate 31 is also used by pressing it against an object such as the skin. Returning to Fig. 1 , in the syringe 80, the plunger 85 moves within the outer cylinder 82 of the syringe barrel 81 when the pressing piece 86 at the rear end is pressed, and the content L is released from the syringe 80 into the fine needle plate 31 via the mounting frame 32.

[0150] In this embodiment, when the contents L reach the tip of the nozzle 84 of the syringe 80, the contents L pass through the flow path hole 325 of the mounting frame 32 and are sent via the discharge hole 315 of the fine needle plate 31 to the object, such as the skin, against which the fine needle plate 31 is pressed.

[0151] 21, in the fine needle plate 31, the height (a) of the base portion 313 is preferably 200 μm≦a<3000 μm, and the height (b) of the needle portion 314 is preferably 5 μm≦b<600 μm.

[0152] In this case, it is preferable that the total height (a+b) of the height (b) of the needle portion 314 and the height (a) of the base portion 313 is 600 μm to 3200 μm. In addition, it is preferable that the ratio (b / a) of the height (a) of the base portion 313 to the height (b) of the needle portion 314 is 0.5 or less, and therefore the dimensions are set so as to satisfy this total value and ratio within the recommended ranges of the height (a) of the base portion 313 and the height (b) of the needle portion 314.

[0153] 21, the tip diameter (d) of base 313 is preferably 300 μm≦d≦600 μm, and the diameter of the base of needle 314 is set to be smaller than the tip diameter of base 313. Furthermore, to improve contact with the skin, it is preferable that the edge of tip surface (top surface) F2 of base 313 is rounded.

[0154] Figure 22 is a bottom perspective view of an example of a fine needle part 3 of the present invention. The fine needle plate 31 of the present invention may have any number of two-stage needles 312, which are needles with bases in which a base 313 and needles 314 are integrally formed, but more preferably, there are more than one. Furthermore, when multiple two-stage needles 312 are provided, it is preferable that they are arranged regularly. Figure 22 shows an example in which the vertices of the needles 314 are arranged in a diagonal lattice pattern (triangular array) when viewed from the bottom of the fine needle plate 31, but the vertices of the needles 314 may also be arranged in a lattice pattern (square array).

[0155] Also, as shown in Figures 21 and 22, when multiple two-stage needles 312, each consisting of a base and a needle, are arranged to protrude from a plate substrate 311, it is preferable that multiple bases 313 are arranged at a distance from each other and that the pitch (c) between the vertices of the needles 314 is 1 mm ≦ c < 5 mm.

[0156] It is preferable that the ratio ((a+b) / c) of the sum of the height (a) of the base 313 and the height (b) of the needle 314 to the pitch (c) of the needle 314 is 0.3 or more and 1.1 or less. This makes the distance (e) between the edges of the tip surfaces F2 of the bases 313 0.5 mm or more and 4.4 mm or less.

[0157] In addition, the number of pedestals 313 per unit area on the plate substrate 311 is 0.1 / cm ２ More than 33 pieces / cm ２ The following is preferable:

[0158] In the microneedle part 3 in this configuration example, the liquid flowing from the mounting tube 326 passes through the flow path hole 325 in the center of the perforated bottom surface 328, spreads as a puddle in the space S on the upper surface of the plate substrate 311, and then enters the multiple injection holes 315.

[0159] The liquid that has entered the multiple outlet holes 315 is allowed to penetrate into the inside of the target object through the fine needle portion 314. In this case, in this embodiment, the base portion 313 is provided integrally with the needle portion 314, which is expected to spread the target object, for example, the skin, and improve puncture performance.

[0160] In this embodiment, as shown by the dotted lines in Fig. 22, flow paths may be provided radially on the upper surface of the plate substrate 311. Details of the flow paths will be described later with reference to Fig. 23.

[0161] The fine needle plate 31 including the double-stage needles 312 of the present invention is preferably made of a biocompatible material, such as a biodegradable resin, such as polyglycolic acid, polylactic acid, or polyglycolic acid-polylactic acid copolymer, but may also be made of a thermoplastic resin, such as polypropylene (PP), polyethylene (PE), acrylonitrile butadiene styrene (ABS), polybutylene terephthalate (PBT), polyacetal (POM), polyethylene terephthalate (PET), polycarbonate (PC), polyether ether ketone (PEEK), or cycloolefin polymer (COP). Biocompatible metal materials, such as stainless steel, cobalt alloy, or titanium alloy, as well as silicone and ceramic, can also be used.

[0162] Furthermore, the mounting frame 32 according to this embodiment is preferably made of a resin such as a thermoplastic resin such as PP, PE, ABS, PBS, POM, PET, PC, PEEC, or COP, or a biodegradable resin such as polylactic acid (PLA), polyglycolic acid (PGA), or polylactic-glycolic acid copolymer (PLGA).

[0163] <Second configuration example of the microneedle part of the fourth embodiment> In the above example, the upper surface of the plate substrate 311 and the lower surface of the flow path plate 322 are both flat, but a conductive path may be formed to move the liquid more efficiently from the center to the radially outward direction.

[0164] The configuration in which a conductive path is formed in the integral hollow microneedle part 3 of this embodiment will be described with reference to Figures 22 and 23. Figure 23 is an enlarged cross-sectional view of a microneedle part 3A of a second configuration example of the fourth embodiment.

[0165] In this configuration example, as shown in Figure 22, in the fine needle plate 31A, multiple two-stage needles 312, which are needle portions with bases each consisting of a base portion 313 and a needle portion 314, are provided at positions other than the center of the plate substrate 311A ​​so as to protrude from the plate substrate 311A.

[0166] 22 , which is a bottom view, the dotted lines extending radially from the flow path holes 325 are the conductive paths G. In this configuration example, as shown in FIGS. 22 and 23 , the conductive paths G are formed by forming grooves (band-shaped recesses) 316 on the upper surface (second surface) F0 of the plate substrate 311 in the region of the shortest path for liquid to flow from the center to the plurality of ejection holes 315. In this case, as shown in FIG. 23 , the upper surface F0 of the plate substrate 311 outside the grooves 316 and the lower surface F3 of the flow path plate 322 may be in contact with each other, with no gaps other than the grooves.

[0167] As a further modification of this example, the upper surface F0 of the plate substrate 311A ​​may be brought into contact with the lower surface F3 of the flow path plate 322, and a strip-shaped groove portion (not shown) may be formed radially on the lower surface F3 of the flow path plate 322 as shown in FIG. 22, thereby forming a conductive path G as a space through which liquid can pass.

[0168] In this second configuration example, a conductive path is formed by providing a radial groove portion that is not in contact with the surface of the plate substrate 311A ​​or the flow path plate 322, so that the plate substrate 311A ​​and the flow path plate 322 can be in contact with each other in parts other than the groove portion, as shown in Figure 23, thereby reducing dead space in the microneedle parts and making them smaller.

[0169] <Third configuration example of the fourth embodiment of the microneedle part> In the above Figure 23, an example is shown in which a conductive path is formed by providing radial grooves in the plate substrate 311 or the flow path plate 322, but the conductive path may also be formed by providing another member between the plate substrate 311 and the flow path plate 322.

[0170] 24 is an enlarged cross-sectional view of a microneedle part 3B according to a third configuration example of this embodiment. In this configuration example, in the gap space S formed by closely arranging the entire upper surface F0 of the plate substrate 311B and the entire lower surface F3 of the flow path plate 322, a filler FL is provided in the area other than the area that forms the shortest path for liquid to flow from the center to the multiple discharge holes 315, thereby forming a conductive path G as a space through which the liquid passes.

[0171] As shown in Figures 22 and 24, by providing a conduit G rather than a central needle, the liquid can be moved more efficiently in a linear radial direction from the center to the outside without spreading throughout the gap space, allowing the liquid to be delivered to the subject more quickly and almost evenly from all needles. Furthermore, by providing the conduit G, the liquid does not remain throughout the gap space, reducing liquid waste and maximizing the delivery of the liquid contents to the subject. Furthermore, because the space to fill with the liquid is small, only a small injection operation is required to fill the space during the initial injection operation, allowing the liquid to be injected into the skin immediately.

[0172] Alternatively, as a method for discharging liquid completely evenly from all needles, the conductive paths may be designed so that they are all the same length from the central flow path hole 25 to each individual needle hole. For example, a conductive path may be formed so as to detour when the needle is close to the center, and a conductive path may be formed in a straight line when the needle is close to the outer periphery.

[0173] <Application Example 2: Knock-Type Injection Device> FIG. 25 is an overall view of a knock-type injection device, which is Application Example 2, equipped with a fine needle part according to one embodiment of the present invention.

[0174] The knock-type injection device 80α in Figure 25 has the same connection configuration with the fine needle part at the tip end as in Figure 1, but differs in that by knocking the pressing part 85α at the rear end, the internal spring Sp pushes the contained contents by a predetermined length, and a predetermined amount is extruded.

[0175] 1 illustrates an example of a syringe as a skin puncture device to which a fine needle part having any of the configurations of the present invention can be attached. When using a syringe, if an appropriate amount is to be dispensed in multiple doses, it is necessary to press the syringe while reading the scale to eject the liquid. However, in this application example, a knock-type syringe can be used to dispense a fixed amount in multiple doses.

[0176] 25 illustrates an example of a knock-type injection device for administering a fixed amount, but an example of a fine needle part to which the fine needle part of the present invention can be applied is, for example, a dial-type injection device that administers a fixed amount by rotating the shaft in the circumferential direction. The knock part or dial part may also be provided on the side of the shaft.

[0177] In this application example, the mounting method is the same as that in Figure 1, so any of the fine needle parts of the first, second, third, and fourth embodiments can be mounted on the knock-type injection device 80α in Figure 26.

[0178] <Application Example 3: Injection Device> Next, an injection device equipped with a fine needle plate of the present invention will be described using Figure 26. The fine needle plate 11 of the present invention can be used by being attached to an injection device 200. Figure 26 is an overall cross-sectional view of injection device 200 in which a fine needle plate 11β according to one embodiment of the present invention is attached to an injection mechanism 90.

[0179] In this application example, the injection mechanism 90 to which the fine needle plate 11β is attached comprises an injection device main body 91 and a plunger 95. The injection device main body (injection guide body) 91 of this configuration contains a liquid content, and the plunger 95 is inserted into it. More specifically, the injection device main body 91 comprises a cylindrical outer tube portion 92 that contains the content, and a head (pressing portion, support portion) 93 that widens outward in a flange-like shape at the tip end.

[0180] 26 , the tip surface of the head 93 has a thin plate portion 931 that forms the storage top surface and a thick outer edge portion 932 that forms the storage side wall, forming a recess toward the tip side, and a step between the thin plate portion 931 and the thick outer edge portion 932. The inner surface of the thick outer edge portion 932 forms a recess side surface 933. A flow hole 934 is formed in the center of the thin plate portion 931 of the head 93. In this application example, the thin plate portion 931 functions as a flow path plate.

[0181] In this configuration, when the fine needle plate 11β is attached to the injection mechanism 90, the outer periphery of the fine needle plate 11β is fitted into the radially inner side of the recessed portion side surface 933 on the underside of the head 93.

[0182] 26, a side hole 921 may be formed on the outer peripheral surface of the outer tube portion 92. For example, when the same person wants to increase the amount of the contents to be applied to the target object at one time, the contents are injected into the outer tube portion 92 through the side hole 921 using a dropper or the like. At this time, the amount of the contents is set so that it is below the side hole 921.

[0183] The rear end of the plunger 95 (plunger) is provided with a widened flange-shaped or wing-shaped pressing piece 96 extending in two directions. A gasket 97, which is a thin rubber or elastomer packing to prevent liquid leakage and foreign matter from entering, is adhered to the tip of the plunger 95. In this configuration, the plunger 95, pressing piece 96, and gasket 97 form a pressing portion. Note that the gasket 97 does not necessarily have to be provided.

[0184] Furthermore, in this application example, the inner periphery of the outer tube portion 92 is formed as a hollow portion 94. Note that, although Fig. 26 shows a state in which an absorbent body 98 such as a sponge is set inside the hollow portion 94 of the outer tube portion 92, in this application example, the absorbent body 98 does not have to be provided.

[0185] In this configuration, by pressing the pressing piece 96 of the plunger 95 while the fine needle plate 11 is pressed against the object, the plunger 95 descends inside the outer tube 92, and the liquid previously injected into the hollow portion 94 through the side hole 921 passes through the absorber 98, is forced out through the flow hole 934 and the outlet hole 14, and is gradually applied to the object. Note that if the absorber 98 is not provided, the liquid previously injected into the hollow portion 94 is immediately forced out through the flow hole 934 and the outlet hole 14 of the fine needle plate 11 and applied to the object.

[0186] In this application example, the part corresponding to the mounting frame 12 is integrated with the tubular part of the injection device, so from the standpoint of design, it is preferable to use the fine needle parts 1, 3 of any of the first, third, or fourth embodiments described above.

[0187] <Application Example 4: Needle Applicator> Next, a needle applicator equipped with a fine needle plate of the present invention will be described with reference to Fig. 27. Fig. 27 is an overall cross-sectional view of a needle applicator 300 equipped with a fine needle plate 31γ according to a fourth embodiment of the present invention.

[0188] The needle applicator 300 to which the microneedle plate of the present invention is attached is a stamp-type puncture and injection device that injects liquid into the interior of a target (for example, skin) through the interior of multiple microneedles.

[0189] 27, the needle applicator 300 includes a grip housing 71, a fine needle plate 31γ, an absorbing member 78, and a pressing member 75. The portion of the needle applicator 300 excluding the fine needle plate 31γ is referred to as an applicator section 70.

[0190] The grip housing 71 is a support (housing) that is open at the top and includes a side wall 72 and a support wall 73. The side wall 72 is a cylindrical peripheral wall. The support wall 73 is a lower surface that connects to the inner surface near the bottom end of the side wall 72, expands in a direction approximately perpendicular to the side wall 72, and covers the bottom of the grip housing 71.

[0191] The side wall 72 is bounded by the support wall 73, with the upper side (proximal end side) of the support wall 73 being a storage wall 721 and the lower side (distal end side) of the support wall 73 being a leg portion 722. The lower end of the leg portion 722 of the side wall 72 is thinner on the inside than on the top, creating a step, and as a result, the periphery of the edge of the lower surface of the support wall 73 is a thick lower surface, which serves as a liquid stopping wall portion 73LO.

[0192] In this application example, one flow hole 74 penetrating in the vertical direction is formed in the center of the support wall 73. In this configuration, the support wall 73 functions as a flow path plate.

[0193] The grip housing 71 is made of a resin, such as a thermoplastic resin such as PP, PE, ABS, PBT, POM, PET, PC, PEEK, or COP, or a biodegradable resin such as polylactic acid (PLA), polyglycolic acid (PGA), or polylactic-glycolic acid copolymer (PLGA). Alternatively, a biocompatible metal material such as stainless steel, a cobalt alloy, or a titanium alloy, or silicone, ceramic, or glass may also be used.

[0194] The needle applicator 300 of this application example is small, and for example, the outer diameter of the side wall 72 of the grip housing 71 is about 8 to 50 mm, more preferably about 10 to 40 mm. Note that although the outer shape of the side wall 72 is not shown in this example, the shape of the outer shape of the side wall 72 when viewed from above may be different, such as a circle, an ellipse, a rectangle, a polygon, a polygon with rounded corners, or a substantially semicircular shape.

[0195] The height of the side wall 72 of the grip housing 71 is approximately 6 to 30 mm, and more preferably approximately 8 to 20 mm. The side wall 72 is 6 mm or more thick, allowing the user to grasp the side wall 72 from the radially outer side. The thickness of the side wall 72 is approximately 1 to 10 mm, and more preferably approximately 1 to 5 mm.

[0196] The fine needle plate 31γ is a plate provided with a plurality of downward-facing fine needles to be inserted into a target object. In this application example, the fine needle plate 31γ is fitted into the inner periphery of the thin-walled portion of the leg portion 722 of the gripping housing 71. As a result, as shown in FIG. 27 , the fine needle plate 31γ is attached to the gripping housing 71 below the lower surface of the support wall 73, spaced apart by the length of the liquid stopping wall portion 73LO.

[0197] The microneedle plate 31γ of this application example has the same structure and material as the fourth embodiment. However, in this structure, the plate substrate 311γ of the microneedle plate 31γ fits into the side wall 72 of the grip housing 71, so the outer diameter of the plate substrate is about 6 to 48 mm, more preferably about 8 to 36 mm.

[0198] The absorbing member 78 is impregnated with liquid. The absorbing member 78 may be impregnated with liquid in advance or immediately before use. The absorbing member 78 is radially inside the side wall 72 of the grip housing 71 and can be fitted into the upper side (rear end side) of the support wall 73. When fitting the absorbing member 78 into the grip housing 71, it is preferable to set the lower surface of the absorbing member 78 so that it abuts against the upper surface of the support wall 73.

[0199] The absorbent member 78 is made of a permeable material such as a sponge (puff), cotton, or nonwoven fabric, which is made of a material that allows liquid to pass through gradually.

[0200] The pressing member 75 functions like a plunger and includes a columnar pressing body 76 and an elastic portion 77 provided at the lower end of the pressing body 76. A portion of the pressing member 75 can be fitted inside the side wall 72 of the grip housing 71. The pressing member 75 is fitted onto the absorbing member 78 in the grip housing 71 and is pressed down along the inner circumferential surface of the side wall 72.

[0201] The upper surface of the pressing body 76 is pressed by the user when the pressing body 76 is pressed to inject liquid into a target object. The pressing body 76 is made of a resin, such as a thermoplastic resin such as PP, PE, ABS, PBT, POM, PET, PC, PEEK, or COP, or a biodegradable resin such as polylactic acid (PLA), polyglycolic acid (PGA), or polylactic-glycolic acid copolymer (PLGA). Biocompatible metal materials such as stainless steel, cobalt alloy, or titanium alloy, as well as silicone, ceramic, or glass, can also be used.

[0202] The elastic portion 77 seals the absorbing member 78 from above when the pressing member 75 is fitted onto the absorbing member 78. The elastic portion 77 is made of, for example, a thin rubber or elastomer packing (sealing element), and being made of such a material can prevent liquid leakage and the intrusion of foreign matter.

[0203] The diameter of the pressing member 75 is, for example, about 10 to 30 mm, more preferably about 15 to 25 mm, and the height of the pressing member 75 is 30 mm or less, more preferably 25 mm or less, but the size of the pressing member 75 is set appropriately depending on the size of the side wall 72 of the grip housing 71. In particular, the elastic portion 77 is set to a size that allows it to come into close contact with the inner circumferential surface of the side wall 72. The shape of the upper surface of the pressing member 75 is also set appropriately to match the shape of the outer shape of the side wall 72 when viewed from above.

[0204] Furthermore, the pressing member 75 may be shaped so that it is pressed in by rotating it rather than being pressed straight in. A part of the pressing member 75 (internal thread) fits into the outer side surface (external thread) of the grip housing 71, and the absorbing member 78 is pressed and injected by screwing it in. At this time, the pressing member 75 may be shaped so that it is screwed in before injection, and when injection is performed, injection can be performed by pressing a button.

[0205] In this application example, one type of content that is pre-contained in the absorbent member 78 can be injected into the object. Alternatively, in addition to the content that is pre-contained in the absorbent member 78, a liquid content that is additionally injected before the pressing member 75 is set can be further contained, and the two types of content can be mixed and injected into the object.

[0206] Furthermore, the needle applicator 300 in this application example may be a puncture injection kit that is assembled immediately before use, in which additional contents are injected and then a liquid containing two types of contents is applied to the target object, in which case it is a single-use item.

[0207] In this application example, since the mounting frame is integrated with the cylindrical portion of the injection device, it is preferable that the fine needle parts 1, 3 are the fourth embodiment, or any of the first and third embodiments.

[0208] <Application Example 5: Push-Head Injection Device> FIG. 28 is an overall cross-sectional view of a push-head injection device, which is Application Example 5 equipped with a fine needle plate according to one embodiment of the present invention.

[0209] In the above application example, an example was described in which the liquid was pushed out by pushing the rear end side with a plunger or knock, but the present invention may also be applied to a skin puncture device in which the rear end side is not pushed by a plunger or the like.

[0210] In this application example, the mounting frame is integrated with the cylindrical portion of the injection device, and the liquid is applied to the skin by pressing the tip surface, so a fine needle plate 11Dδ is used, which has the same function as the fine needle plate 11D with integrated solid needles in the fifth configuration example of the first embodiment shown in Figures 9 and 10. The fine needle plate 11Dδ in this application example is preferably small, with external dimensions of approximately 8 to 50 mm, and more preferably approximately 10 to 40 mm.

[0211] 28, the fine needle plate 11Dδ can be raised and lowered along the inner periphery of the cylindrical opening 61. The inner periphery of the cylindrical opening 61 is provided with a plurality of protrusions 62 that rise toward the center and are aligned in the circumferential direction.

[0212] 28(a), the sealing valve 118, which is pushed up by the force of an internal spring or the like, comes into contact with the multiple protrusions 62, thereby preventing the microneedle plate 11Dδ from jumping out of the cylindrical opening 61. Furthermore, the sealing valve 118 comes into close contact with the inner wall of the cylindrical opening 61, thereby preventing leakage of the contents.

[0213] 28(b), when the fine needle plate 11Dδ is pressed against an object such as the skin, the fine needle plate 11Dδ is pushed into the cylindrical opening 61, the sealing valve 118 moves, and the sealing valve 118 is released from tight contact with the inner wall of the cylindrical opening 61. Furthermore, since the protrusions 62 do not cover the entire circumference but are present intermittently, liquid that has passed outside the sealing valve 118 (radially outward) passes through the gaps between the multiple protrusions 62 and flows into the skin from outside the outer periphery of the fine needle plate 11Dδ.

[0214] Furthermore, since the needles formed on the fine needle plate 11Dδ are two-stage needles, multiple fine needles can be reliably punctured without being left for a long time, even if the skin to be punctured is deformed, and liquid flowing radially from the outside toward the center can be applied to the skin.

[0215] <Application Example 6: Puncturing and Applying Roller> FIG. 29 is an explanatory view of the entire puncturing and applying roller, which is Application Example 6 equipped with a fine needle plate according to one embodiment of the present invention.

[0216] In the above application examples and embodiments, examples have been shown in which the plate substrate in the microneedle plate including the microneedle parts is a flat substrate, but the microneedle plate 11E may also be cylindrical.

[0217] It is preferable that the microneedle plate 11E of this application example is small, and examples of its external dimensions include a cylindrical tube width, i.e., an outer diameter of the tube, of approximately 8 to 50 mm, more preferably approximately 10 to 40 mm, and a horizontally oriented tube length of approximately 8 to 50 mm, more preferably approximately 10 to 40 mm.

[0218] In this application example, the needles formed on the fine needle plate 11E are two-stage needles, and the plate is cylindrical, so that by rolling the roller without leaving it for a long time, even if the skin to be punctured is deformed, multiple fine needles can be reliably punctured and liquid can be applied to the skin.

[0219] In FIG. 29, the application roller is described as a puncture tool that is integrally configured with a container that contains a liquid, but the puncture tool may be separate from the container.

[0220] 30 is an overall explanatory diagram of a puncturing and infusion set 400, which is application example 6 equipped with a fine needle plate according to one embodiment of the present invention, including a liquid-separate puncturing and application roller 7 and a storage container 8. In this application example, the cosmetic tool has a fine needle plate 11E with two-stage needles formed on its outer surface and includes a gripping tool 5 to be held by a user. The storage container 8 contains a liquid containing, for example, a cosmetic ingredient.

[0221] When using this puncture and infusion set, the needle portion punctures the object before or after applying the liquid contained in the container to the object, thereby applying the liquid onto or inside the surface of the object.

[0222] In this case too, the needles formed on the fine needle plate are two-stage needles, so that by rolling the roller without leaving it for a long time, even if the skin to be punctured is deformed, multiple fine needles can reliably puncture the skin and apply liquid to it.

[0223] In this way, the microneedle parts and microneedle plates of the present invention can be attached to a variety of puncture devices, such as syringes, injection mechanisms, and applicator mechanisms as shown in the above embodiments, depending on the application, desired puncture area, and amount of content injected.

[0224] <<Experimental Example>> The inventors of the present application conducted experiments varying various dimensions to investigate the optimal needle size for the fine needle plate. In the following experiments, skin separated from a human body was used as the puncture target, and a texture analyzer was used to apply a load of 1000 gf perpendicular to the stratum corneum surface, pressing the fine needle plate into the stratum corneum. Then, a staining method using a water-soluble dye was used to count the number of needles that reached the epidermal granular layer or below, thereby evaluating puncture performance.

[0225] <Experimental Example 1> A puncture experiment was conducted by changing the length of the base. Fig. 31 is a table showing the results of a puncture experiment using a fine needle plate of the first configuration example of the first embodiment, using bases of different lengths. In Experimental Example 1, the puncture experiment was conducted using a fine needle plate with a single needle or a single needle with a base.

[0226] The thickness of human skin is approximately 1.0 to 4.0 mm, with the epidermis being approximately 0.02 to 0.2 mm thick. In particular, it has been reported that the thickness of the facial epidermis is approximately 0.02 to 0.12 mm, and the thickness of the dermis is approximately 0.3 to 2.7 mm. When delivering contents into the epidermis and dermis, it is preferable that the height of the needle 314 be 5 μm≦b<700 μm. In this experiment, the length of the needle was fixed at 200 μm (0.2 mm).

[0227] As shown in Figure 31, the puncture performance of the fine needle plate is improved by adding a base. The configurations A3, A4, A5, A6, and A7 have particularly good puncture performance. Therefore, in the fine needle plate 11, the height (a) of the base 113 is preferably 200 μm≦a<3000 μm, and more preferably 400 μm≦a<2000 μm.

[0228] <Experimental Example 2> A puncture experiment was conducted by changing the diameter of the base. Figure 32 is a table showing the results of a puncture experiment using a fine needle plate using a base with different tip diameters in the first configuration example. In Experimental Example 2, a puncture experiment was conducted using a fine needle plate with a configuration in which only one needle or a needle with a base was used.

[0229] As shown in Figure 32, a small base 113 is preferable. The configurations B1, B2, B3, B4, and B5 have particularly good puncture properties. However, in B1, the base 113 is formed continuously with the needle 114 at the tip, so the base 113 also pierces the skin. Therefore, it is preferable that the tip diameter (d) of the base 113 is 200 μm < d ≦ 600 μm, and the diameter of the base of the needle 114 is set to be smaller than the tip diameter of the base 113.

[0230] <Experimental Example 3> When multiple needles were used, a puncture experiment was conducted for configurations with and without a base. Figure 33 is a table showing the results of a puncture experiment using a fine needle plate with and without a base, in which multiple needles were arranged in a row (array).

[0231] It can be seen that even when multiple needles are arranged in an orderly fashion, needles without bases are less likely to pierce the skin, while needles with bases are more likely to pierce the skin. As a result, bases 113 spread the surface of an elastic object such as skin before needles 114 puncture it, so even when multiple needles are arranged in an array, tip surfaces F2 of each base 113 come into contact with the object and spread the surface of the object, improving the puncture rate.

[0232] <Experimental Example 4> A puncture experiment was conducted using multiple needles and varying the pitch. Fig. 34 is a table showing the results of a puncture experiment in which multiple base-equipped needles were arranged in a row, with the same number of needles but varying the pitch.

[0233] As shown in Figure 34, good puncture results were achieved when the pitch was 2 mm, 3 mm, and 4 mm, but the puncture rate decreased when the pitch was 5 mm. The base 113 spreads the surface of an elastic object, but if the spacing is too wide, the object tends to be concentrated in the gap between the edges of the tip surfaces F2 of the bases 113, where no base-attached needles are present, weakening the spreading effect. Therefore, it is preferable that the pitch (c) between the apexes of the needles 114 be 1 mm ≤ c < 5 mm, and more preferably 2 mm ≤ c < 4 mm. However, even if the pitch is wide, if the tip diameter of the base 113 is large, the gap between the edges of the tip surfaces F2 of the bases 113 does not become very wide. Therefore, it is preferable that the gap (e) between the edges of the tip surfaces F2 of the bases 113 be 0.5 mm or more and 4.4 mm or less.

[0234] Furthermore, since the depth of pressing when spreading the object varies depending on the height (a) of the base portion 113, the total length of the height (a) of the base portion 113 and the height (b) of the needle portion 114 is also taken into consideration, and it is preferable that the ratio ((a+b) / c) of the total height (a) of the base portion 113 and the height (b) of the needle portion 114 to the pitch (c) of the needle portion 114 is 0.3 or more and 1.1 or less.

[0235] <Experimental Example 5> A puncture experiment was conducted by using multiple needles and changing the number of needles without changing the pitch. Figure 35 is a table showing the results of a puncture experiment in which multiple base-equipped needles were arranged in a row and the number of needles was changed at the same pitch.

[0236] As shown in Figure 35, for the same pitch, the puncture rate decreases as the number of needles increases. The effective puncture area was calculated by calculating the estimated coverage area from the maximum diameter of the base-attached needles on the fine needle plate, indicated by the arrow, and multiplying this by the puncture rate. Figure 36 is a graph showing the ratio of the effective puncture area to the coverage area of ​​the fine needle plate in Figure 35.

[0237] To improve the puncture rate of configurations D2 and D3, which have a large microneedle plate substrate 111 and a low puncture rate, it is considered effective to increase the load per needle during puncture. In this case, it is necessary to select a device that can apply an appropriate force. Specifically, the force applied to the target object in this experiment was 1000 gf (1 kgf). The force applied per needle was calculated as follows: D1: 143 gf, D2: 53 gf, and D3: 18 gf.

[0238] Based on the load applied to each needle, the force required to puncture D2 by 70% can be calculated as approximately 2700 gf using the formula 143 gf × 19 needles to achieve the same puncture rate for D1 and D2. For example, with injection device 200 shown in Fig. 26, needle applicator 300 shown in Fig. 27, and injection device 6 shown in Fig. 28, the area over which force is applied when pushing from the rear end is large, allowing the entire fine needle plate to be pressed, making it easier to apply force than with a single finger and thus achieving this force.

[0239] The size of the through-hole, particularly the tip of extraction hole 14, is set to an optimum value according to the thickness of needle portion 114, but a tapered shape that gradually narrows from the rear end to the tip is preferred. The diameter of the tip is, for example, about 5 to 100 μm, more preferably 10 to 50 μm.

[0240] 1 and 25 to 30, when the fine needle parts of the first, third, or fourth embodiments are attached to the application examples shown in the above-mentioned figures, the needle portion and base portion are integrally formed with the above dimensions, so that the base portion spreads the surface of the target object, such as the skin, and the needle portion punctures, thereby improving the puncture rate even when multiple needles are arranged in an array. This allows a liquid with some effective effect, such as a liquid composition / liquid cosmetic with any active ingredient, to be reliably delivered to the target object while spreading it, and retained inside the target object near its surface.

[0241] Furthermore, even when the fine needle part of the second embodiment is attached to any of the application examples shown in Figures 1 and 25 to 27 above, the tubular portion into which the needle-like protrusions formed on another plate with the same dimensions as above are inserted causes the tip of the tubular portion to spread apart the surface of the target object such as skin, allowing the needle-like protrusions to puncture, thereby improving the puncture rate even when multiple needles are arrayed.

[0242] Although the contents (liquid substances) used in the syringes, injection devices, and needle applicators to which the microneedle plates or microneedle parts in the above-described embodiments of the present invention are connected have been described above as simply liquids, the contents may specifically be selected from the group consisting of cosmetic substances, cell suspensions, gel-like materials, therapeutic substances, and diagnostic substances.

[0243] Cosmetic substances include common cosmetic substances that can be included in cosmetic compositions and cosmetic substances used in cosmetic medicine, such as ascorbic acid and its derivatives, tranexamic acid, arbutin, and 4-MSK (4-methoxysalicylic acid potassium salt) for whitening purposes, and retinol, niacinamide, hyaluronic acid and its derivatives for anti-wrinkle purposes, but are not limited to these.

[0244] In addition to common cosmetic substances that may be included in cosmetic compositions, the injected cosmetic substances may include, but are not limited to, fillers such as fat cells, hyaluronic acid, or botulinum toxin (Botox, Btx) in wrinkle treatment.

[0245] Therapeutic substances may include, but are not limited to, antibiotics, anesthetics, analgesics, vaccines, and antibodies.

[0246] Additionally, the microneedle plate of the present invention may be used to inject cells in suspension or in a liquid medium into a subject as the contents contained within a syringe.

[0247] Additionally, the contents contained within the syringe may include a cell suspension mixed with growth factors or a gel-like structure, preferably representing a mixture of extracellular matrix proteins that mimic the extracellular environment of distinct tissues, more preferably a gel-like structure such as hyaluronic acid.

[0248] Although human skin has been described above as an example of an object to which a liquid can be applied using a syringe, injection device, or needle applicator equipped with the fine needle plate of the present invention, the object can also be animal skin, the surface of plant stems, trunks, or leaves, etc. Alternatively, the object may be tissue such as skin or organs removed from a subject or test animal.

[0249] Although the preferred embodiments of the present invention have been described in detail above, the present invention is not limited to such specific embodiments, and various modifications and changes are possible within the scope of the gist of the embodiments of the present invention described in the claims.

[0250] This international application claims priority based on Japanese Patent Application No. 2022-056466, filed on March 30, 2022, the entire contents of which are incorporated herein by reference.

[0251] 1, 1A, 1B, 1C, 1D, 1α, 2, 2A, 2B, 2C, 2D, 3, 3A, 3B, 4, 4A, 4B, 4C Fine needle parts 11, 11B, 11C, 11D, 11β, 11Dδ Fine needle plate (solid type, needle plate) 111, 111B, 111C, 111D Plate substrate 112 Two-stage needle (solid) 113 Base portion 114 Needle portion (tip needle) 115 Lip portion 116 Spout hole 118 Sealing valve 12, 12B, 12C, 12D Mounting frame 123L Lip portion 131 Fine needle plate 21 Abutment plate 316, 216A, 216B Cylindrical portion (base portion) 317 Hollow 22 Mounting frame 222 229, 229A, 229C Acicular projection (needle portion) 31, 31A Fine needle plate 311, 311A ​​Plate substrate 312 Two-stage needle (hollow two-stage needle) 313 Base portion 314 Needle portion (tip needle) 315 Discharge hole 316 Cylinder portion 317 Hollow 32 Mounting frame 322 Flow path plate 41 Fine needle plate (solid type, needle plate) 411 Plate substrate 412, 412A, 412B, 412C Two-stage needle with lip (solid) 413 Base portion 414 Needle portion (tip needle) 415 Individual lip 416 Discharge hole 42 Mounting frame 70 Applicator portion (puncture device) 80 Syringe (puncture device) 90 Injection mechanism (puncture device) 100 Syringe set 200 Injection device 300 Needle applicator F13 Tip concave surface of base F15 Tip surface of individual lip

Claims

1. A fine needle part to be attached to a skin puncture device, a plate-shaped substrate; a plurality of pedestals protruding from a surface of the plate substrate facing the object; a plurality of needle portions protruding from the top surfaces of the plurality of base portions, The height (b) of each of the plurality of needle portions is 5 μm≦b<700 μm, The height (a) of each of the plurality of pedestals is 200 μm≦a<3000 μm, The total height (a+b) of the height (b) of each needle portion and the height (a) of each base portion is 600 μm to 3200 μm, the plurality of base portions and the plurality of needle portions are formed of an insoluble resin material, The needle portion punctures the object to provide a liquid onto or inside the object. Fine needle parts.

2. the plate substrate, the plurality of base portions, and the plurality of needle portions are integrally formed, so that the plurality of base portions and the plurality of needle portions become a plurality of two-stage solid needles, One or more injection holes are formed in the plate substrate, a lip portion formed on the outer edge of the tip surface of the plate substrate, When the liquid is extruded from the ejection hole, the liquid spreads in a space formed between the object, the lip portion, and the tip surface of the plate substrate, and the liquid enters the inside of the object through holes formed by the needle portions of the plurality of two-stage solid needles. The microneedle part according to claim 1 .

3. the plate substrate, the plurality of base portions, and the plurality of needle portions are integrally formed, so that the plurality of base portions and the plurality of needle portions become two-stage solid needles, One or more outlet holes through which a fluid passes are formed on the top surface of the base so as to vertically penetrate the plate substrate and the base, a lip portion is provided on an outer edge of the top surface of the base portion, thereby forming a recess in the radial center of the top surface, When the liquid is pushed out from the spout hole, the liquid spreads in a space formed between the object, the lip portion, and the recessed portion on the top surface of the base portion, and the liquid also enters the object through holes formed in the object by the needle portions of the plurality of two-stage solid needles. The microneedle part according to claim 2 .

4. The plate substrate, the base portion, and the needle portion are integrally formed, and an injection hole extending in the protruding direction of the needle portion and through which a fluid passes is formed so as to penetrate the plate substrate, the base portion, and the needle portion in the vertical direction. The microneedle part according to claim 1 .

5. a flow channel microneedle plate having flow channel holes formed therein; a contact plate disposed opposite to the tip side of the flow channel fine needle plate, The flow channel microneedle plate has one or more needle-like projections protruding from a surface on the tip side, The abutment plate is an outer plate substrate disposed opposite to the tip side of the flow channel microneedle plate; one or more cylindrical portions protruding from the outer surface of the outer plate substrate; The cylindrical portions are arranged in the same number as the needle-like protrusions but shorter than the needle-like protrusions so that the needle-like protrusions of the flow path fine needle plate protrude from the inner periphery of each cylindrical portion of the abutment plate, thereby forming a two-stage needle in which the cylindrical portions are base portions and the portions of the needle-like protrusions protruding from the cylindrical portions are needle portions; In the microneedle part, the liquid that has passed through the flow path hole spreads as a liquid pool in the space between the outer plate substrate of the flow path microneedle plate, and then the liquid enters the gap between the needle-like protrusions of the flow path microneedle plate and the inner surface of the cylindrical part and is discharged, and the liquid enters the inside of the object through the holes opened by the needle-like protrusions, a protrusion height (b) of each of the plurality of acicular protrusions relative to the outer plate substrate is 5 μm≦b<700 μm; a protruding height (a) of each of the plurality of cylindrical portions from the outer plate substrate is 200 μm≦a<3000 μm; the total height (a+b) of the height (b) of each of the needle-like projections and the height (a) of each of the cylindrical portions is 600 μm to 3200 μm; Fine needle parts.

6. The ratio (b / a) of the height (a) of the base portion to the height (b) of the needle portion is 0.5 or less. The microneedle part according to claim 1 .

7. The tip diameter (d) of the base is 200 μm < (d) ≦ 600 μm, The microneedle part according to claim 1 .

8. The plurality of base portions are arranged at intervals, and the pitch (c) between the apexes of the needle portions is 1 mm≦c<5 mm. The microneedle part according to claim 1 .

9. The ratio ((a+b) / c) of the sum of the height (a) of the base portion and the height (b) of the needle portion to the pitch (c) of the needle portion is 0.3 or more and 1.1 or less. The microneedle part according to claim 1 .

10. The distance between the edges of the top surfaces of the base portions is 0.5 mm or more and 4.4 mm or less. The microneedle part according to claim 8 .

11. The number of the pedestals per unit area is 0.1 / cm ２ Above, 33 pieces / cm ２ Below is the The microneedle part according to claim 1 .

12. The microneedle part comprises a frame; the frame has a lip portion formed on an outer edge of a surface on the tip side, the plate substrate, the plurality of base portions, and the plurality of needle portions are integrally formed, so that the plurality of base portions and the plurality of needle portions become a plurality of two-stage solid needles, When the liquid is pushed out from the gap between the inner edge of the lip portion of the frame and the outer edge of the plate substrate, the liquid spreads into the space formed between the object, the lip portion, and the tip surface of the plate substrate, and the liquid enters the inside of the object through the holes opened by the multiple two-stage solid needles. The microneedle part according to claim 1 .

13. The plate substrate has a cylindrical shape, and the base portion and the needle portion are provided on the outside. The microneedle part according to claim 12.

14. The fine needle part according to any one of claims 1 to 13 is attached to a skin puncture device capable of containing a liquid. Injection device.

15. a cosmetic tool having the injection device according to claim 14 and a gripping tool to be gripped by a user; A puncture and infusion set comprising: a container containing a liquid; After or before the liquid contained in the container is applied to the object, the needle portion punctures the object, thereby applying the liquid onto the surface or inside of the object. Puncture infusion set.

16. A fine needle part to be attached to a skin puncture device, a plate-shaped substrate; a plurality of pedestals protruding from a surface of the plate substrate facing the object; a plurality of needle portions protruding from the top surfaces of the plurality of base portions; Equipped with the plurality of base portions and the plurality of needle portions constitute a plurality of double-stage needles, Each of the plurality of two-stage needles has a two-stage shape, (a) (i) one or more discharge holes through which a fluid passes are formed in the top surface of the base, penetrating the plate substrate and the base; (ii) a lip portion is provided on the outer edge of the top surface of the base, thereby forming a recess in the radial center of the top surface; (iii) the multiple bases and the multiple needle portions are configured such that, when the fine needle part is in contact with the object and liquid is pushed out from the discharge hole, the liquid spreads in the space formed between the object and the recess in the top surface of the base, and the liquid enters the object through holes opened in the object by the multiple two-stage needles; or (b) (i) the fine needle part has a frame, (ii) the frame has a lip portion formed on the outer edge of the surface on the tip side, and (iii) the multiple base portions and the multiple needle portions are configured so that when the fine needle part is in contact with the object and liquid is pushed out from the gap between the inner edge of the lip portion of the frame and the outer edge of the plate substrate, the liquid spreads in the space formed between the object, the lip portion, and the tip surface of the plate substrate, and the liquid enters the inside of the object through holes opened in the object by the multiple two-stage needles. Fine needle parts.

17. The height (b) of each needle portion of the plurality of needle portions is 5 μm≦b<700 μm, The height (a) of each of the plurality of pedestals is 200 μm≦a<3000 μm, The total height (a + b) of the height (b) of each needle portion and the height (a) of each base portion is 600 μm to 3200 μm; The microneedle part according to claim 16.

18. The plurality of base portions and the plurality of needle portions are formed of an insoluble resin material, The fine needle part supplies the liquid onto or inside the object by puncturing the object with the needle part. The microneedle part according to claim 16.

19. Each of the plurality of double-stage needles is a solid needle. The microneedle part according to claim 16.