JP2009225987A - Needle shape body - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a needle shape body capable of suppressing both break and deformation caused by force to be received from skin when the needle shape body with minute projections are made to come into contact with the skin so as to puncture the skin by adding pressurization. <P>SOLUTION: The needle shape body includes: a substrate; a projection group formed on the first surface of the substrate; and a flat part surrounding the projections. In the needle shape body, the shortest distance from the bottom surfaces of the projections positioned in the most outer periphery of the projection group to the outer periphery of the flat part is larger than the height of the projections. <P>COPYRIGHT: (C)2010,JPO&INPIT

Description

  The present invention relates to a needle-shaped body.

  In recent years, as a method of administering a physiologically active substance into a living body, a method of transdermal administration using a needle-like body having a fine protrusion as a needle has been attracting attention. By using such needles to perforate the stratum corneum with high barrier properties to form a passage route for the physiologically active substance, it is possible to obtain a higher efficiency of penetration of the physiologically active substance compared to general transdermal administration. Is possible. At this time, the protrusions of the needle-like body are designed so as not to penetrate the stratum corneum and reach the capillaries and nerves, thereby preventing bleeding and pain during use.

  When using a needle-like body for the purpose of transdermal administration, the protrusion penetrates through the stratum corneum, which is the outermost layer of the skin, and has a sufficient fineness and tip angle to penetrate the skin and reaches the nerve layer. It is desirable to have a length that does not. Specifically, the diameter of the protruding portion is sharp, about several μm to 100 μm, the angle is preferably 30 degrees or less, and the length is preferably about several tens μm to several hundred μm.

  The material constituting the needle-shaped body is preferably a material that does not adversely affect the human body even if the damaged needle part remains in the body, such as a medical silicone resin, maltose, Biocompatible materials such as polylactic acid and dextran are considered promising (Patent Document 1).

  Further, as a method of manufacturing the needle-like body having the fine protrusions described above, a method is proposed in which an original plate of the needle-like body is produced by X-ray lithography, a duplicate plate is made from the original plate, and transfer molding is performed. (Patent Document 2).

There has also been proposed a manufacturing method in which an original plate of needle-like bodies is produced by machining, a duplicate plate is made from the original plate, and transfer molding is performed (Patent Document 3).
Japanese Patent Laid-Open No. 2005-21677 JP 2005-246595 A JP-T-2006-513811

  These needles are often made of a brittle material such as silicon or a resin material, and have a problem that they tend to break or deform when pressed against a thin film such as skin or film for puncture. .

  The present invention has been made to solve the above-described problems, and an object of the present invention is to provide a needle-like body in which both destruction and deformation at the time of puncturing a thin film are suppressed.

In order to solve the above object, the present invention provides:
(1) A needle-like body having a substrate, a projection group formed on the first surface of the substrate, and a flat portion surrounding the projection, the projection positioned on the outermost periphery of the projection group A needle-like body, wherein the shortest distance from the bottom surface of the portion to the outer periphery of the flat portion is greater than the height of the protrusion;
(2) The shortest distance from the bottom surface of the protrusion located on the outermost periphery of the protrusion group to the outer periphery of the flat portion is constant over the entire outer periphery of the protrusion group. The acicular body described;
(3) A plate for producing the needle-like body according to any one of (1) or (2), wherein a substrate, a recess group formed on a first surface of the substrate, A plate comprising a flat part surrounding the concave group, wherein the shortest distance from the opening of the concave part located on the outermost periphery of the concave group to the outer periphery of the flat part is larger than the depth of the concave part;
(4) A multi-face plate for producing the needle-like body according to any one of (1) or (2), wherein the substrate and a plurality of recess groups formed on the first surface of the substrate And a flat portion that surrounds each of the recess groups, and a margin between adjacent flat portions, and the shortest distance from the opening of the recess located on the outermost periphery of the recess group to the outer periphery of the flat portion is A multi-faced plate characterized by being larger than the depth of the recess;
(5) A plate for producing the acicular body according to any one of (1) and (2), wherein a substrate, and a protrusion group formed on the first surface of the substrate; A flat portion surrounding the protruding portion group, wherein the shortest distance from the bottom surface of the protruding portion located on the outermost periphery of the protruding portion group to the outer periphery of the flat portion is greater than the height of the protruding portion, Version to do;
It is.

  According to the present invention, there is provided a needle-like body in which both destruction and deformation at the time of puncturing a thin film are suppressed.

  Hereinafter, the acicular body according to the present invention, the method for producing the acicular body, and the like will be described.

1. Needle-like body The needle-like body according to the present invention comprises a substrate, a projection group formed on the first surface of the substrate, and a flat portion surrounding the projection, and is located on the outermost periphery of the projection group. The shortest distance from the bottom surface of the protruding portion to the outer periphery of the flat portion is larger than the height of the protruding portion.

  Fig.1 (a) is a top view which shows an example of the aspect of this invention. FIG.1 (b) is sectional drawing which cut | disconnected the center top of the projection part located in the outermost periphery of the projection part group of Fig.1 (a) along line II. FIG. 1C is an enlarged view of a part of FIG. 1A, and FIG. 1D is a cross-sectional view taken along line II-II in FIG. The acicular body 1 according to the present invention includes a substrate 2, a projection group 4 including a plurality of projections 3 formed on the first surface of the substrate 2, and a flat portion 5 surrounding the projection group 4 ( FIG. 1 (a)). The protruding portion 3 functions as a needle portion of the needle-like body 1. As shown in FIG. 1D, in the configuration of the present invention, if the shortest distance 6 from the bottom surface of the protrusion 3 located on the outermost periphery to the outer periphery of the flat part 5 is larger than the height 7 of the protrusion 3. Good.

  FIG. 1 shows an example of an aspect of the present invention. The shape and arrangement of the protrusions 3, the shape of the substrate 2, and the shortest distance from the bottom surface of the outermost protrusion 3 to the outer periphery of the flat part 5. The size of the height 6 of the protrusion 6 and the protrusion 3 is not limited to the illustrated form as long as the relationship between the shortest distance 6 and the height 7 described above is maintained.

  The needle-like body according to the present invention is characterized in that the shortest distance 6 from the bottom surface of the outermost protrusion 3 to the outer periphery of the flat part 5 is larger than the height 7 of the protrusion 3. In order to suppress damage to the protrusion 3, it is preferable that the ratio of the shortest distance 6 from the bottom surface of the outermost protrusion 3 to the outer periphery of the flat portion and the height 7 of the protrusion 3 is larger.

  The shortest distance 6 from the bottom surface of the protrusion 3 located on the outermost periphery of the protrusion group 4 to the outer periphery of the flat portion 5 is larger depending on the region if the shortest distance 6 is larger than the height 7 of the protrusion 3. However, it is preferably constant over the entire outer periphery of the protrusion group 4. Further, the width of the flat portion 5 included in one needle-like body may be constant over the entire region or may be different.

  The material for the needle-shaped body is not particularly limited as long as it has sufficient mechanical properties to hold the protrusion. For example, metals such as stainless steel and silicon, inorganic materials such as quartz and ceramics, biocompatible materials such as medical silicone resins, such as polylactic acid, polyglycolic acid, polylactic glycolic acid copolymer, Any biodegradable material having biocompatibility such as acid, polymalic acid, polyamino acid, maltose and dextran, and other organic materials such as other biocompatible and biodegradable polymers may be used.

  When the acicular body is applied to biological skin, the material of the acicular body is preferably biocompatible, and more preferably biocompatible and biodegradable. .

  Moreover, it is preferable that at least the protrusion is formed of a material having biodegradability. By using a biodegradable material, it is possible to reduce the influence on the living body even if the needle-like body is damaged during application to living body skin and a part of the needle body is left in the living body.

  In addition, the protrusion may be made of the same material as that of the substrate, or may be made of a material different from that of the substrate. When using another type of material, the material used as the substrate may be, for example, silicon, stainless steel, polycarbonate, and the like, and the material of the protrusions may be polylactic acid, polyglycolic acid, and maltose. For example, when silicon is used as the substrate and polylactic acid is used as the protrusions, for example, only the polylactic acid protrusions may be selectively hot-press molded on the silicon substrate.

  The shape of the protrusion may be freely designed depending on the application. For example, when used for the purpose of promoting percutaneous absorption of a physiologically active substance or for the purpose of percutaneously extracting a substance in a living body to the outside of the living body, the protrusion provided on the needle-like body from the viewpoint of skin puncture performance It is desirable that the tip of the part has a sharp cone shape, the root width is several μm to several hundreds μm, the length is about several tens μm to several hundreds μm, and the side wall of the protruding part has no constriction or step.

  When the fine protrusions are formed as an arrayed group, the protrusions located on the outer periphery of the group are likely to be damaged or deformed. This is because when the needle-like body is pressed against a thin film such as skin or film, the thin film in the region corresponding to the protrusion group is deformed by the pressing, and only the protrusions located on the outer periphery of the protrusion group are inclined downward. This is due to the force being applied. As a result, the protrusions located on the outer periphery of the group are likely to be damaged or deformed. According to the present invention, it is possible to suppress such damage and deformation.

  The needle-shaped body may be produced directly from a needle-shaped body-forming material by a method known per se, for example, precision machining, and is transferred and molded using a mold or a replica plate by a method known per se. May be manufactured.

  When manufacturing using a metal mold | die, it is possible to manufacture as follows, for example. Please refer to FIG. This example is an example using a mold 10 having a first surface of a substrate 11 having a pattern in which a first surface having protrusions of a needle-shaped substrate to be manufactured is inverted. The mold 10 includes a recess 12 in a substrate 11. The needle-shaped body molding material 13 is applied to the mold 10 (FIG. 2A), and the protrusions are transferred to the needle-shaped body molding material 13 (FIG. 2B). After curing, the needle-shaped body molding material 13 is peeled off from the mold 10. As a result, the needle-like body 15 having the protrusion group 16 including the plurality of protrusions 14 on the first surface of the substrate 18 is obtained.

  Moreover, you may cut | disconnect the board | substrate 18 in the area | region of the flat part 17 as needed (FIG.2 (d)). Here, in the needle-like bodies 15 and 19 according to the present invention, the shortest distance 20 from the bottom surface of the protrusion 14 located on the outermost periphery of the protrusion group 16 to the outer periphery of the flat portion 17 is the height of the protrusion 14. It is characterized by being larger than 21 (FIGS. 2D and 2E). Accordingly, if such a feature is obtained, the substrate 18 may be arbitrarily cut within the region of the flat portion 17.

  The material of the mold may be any material known per se that is generally used as a mold. For example, it can be processed by fine processing techniques such as lithography, wet etching, dry etching, etching such as plasma etching and reactive ion etching, laser processing, blast processing such as focused ion beam and sand blasting, and precision machining. Anything is acceptable. For example, metal materials such as silicon, aluminum, and stainless steel, and synthetic resins such as polycarbonate, polystyrene, acrylic resin, and fluororesin may be used.

  Although there is no restriction | limiting in particular in the manufacturing method of the said metal mold | die, You may use a well-known manufacturing method suitably according to the shape of the acicular body to produce. For example, it is possible to produce a desired mold by a fine processing technique. Examples of such microfabrication techniques include, but are not limited to, lithography, wet etching, dry etching, plasma etching and reactive ion etching, and other blasting processes such as laser processing, focused ion beam, and sand blasting. And precision machining methods.

  The filling method of the needle-shaped body molding material into the mold is not limited to this, but from the viewpoint of productivity, the imprint method, hot embossing method, injection molding method, extrusion molding method and casting method are suitable. It is preferable to use for.

  Moreover, in order to improve the releasability of the needle-shaped body forming material, the mold may be subjected to known surface shape processing and / or chemical surface modification. Examples of surface shape processing used in the present invention are patterning by laser processing or etching processing, improvement of surface roughness, etc., and examples of chemical surface modification are lubricants and mold release agents. It is the creation of a release layer by painting and the creation of a gisei layer by forming a metal film. By improving the peelability, it is possible to more stably maintain a needle-like body having fine protrusions.

2. Plate The present invention further provides a plate used for forming the needle-like body. The plate according to the present invention includes an original plate and a duplicate plate, and may be a single-sided plate or a multi-sided plate.

(1) Mold The mold according to the present invention may have the same configuration as the target needle-like body, that is, the same pattern as the surface of the needle-like body including the protrusions of the target needle. You may have a pattern obtained by reversing the surface including the protrusion part of a shape body. Therefore, when the mold has the same pattern as the needle-like body, the mold includes a substrate, a protrusion group formed on the first surface of the substrate, and a flat portion surrounding the protrusion. And the distance from the bottom surface of the protruding portion located on the outermost periphery of the protruding portion group to the outer periphery of the flat portion may be larger than the height of the protruding portion. Further, when the mold has a pattern obtained by reversing the surface including the protrusion of the needle-like body, the mold includes a substrate and a group of recesses formed on the first surface of the substrate. And a flat portion surrounding the concave group, and the shortest distance from the opening of the concave portion located on the outermost periphery of the concave group to the outer periphery of the flat portion may be larger than the depth of the concave portion.

  The mold may be made by any means known per se using any material known per se. In the case where the mold has a pattern obtained by reversing the surface including the protrusions of the needle-like body, for example, the mold may be manufactured by the above-described means using the above-described material.

  Further, even when the mold has the same pattern as the needle-like body, it may be manufactured by any method known per se using the above-described mold material. The method for forming the protrusions on the material of the mold is, for example, a fine processing method, for example, etching such as lithography, wet etching, dry etching, plasma etching and reactive ion etching, laser processing, focused ion beam, Includes blasting such as sandblasting and precision machining.

  When the mold has the same structure as the needle-shaped body, the needle-shaped body is manufactured by using the mold as an original plate, producing a duplicate plate, and transferring and molding the replica plate pattern onto the needle-shaped body forming material. A needle-like body may be prepared. When the mold has a concave-convex pattern on the surface including the protrusions of the needle-like body, the needle-like body may be transferred by applying a needle-like body forming material to the mold.

  Moreover, the said metal mold | die may be used as a single-sided metal mold | die, and may be used as a multi-surfaced metal mold | die for multi-faced. When used as a multi-sided mold, it is desirable that there is a margin between adjacent flat portions.

(2) Replica plate The needle-shaped body according to the present invention may be produced using a replica plate. In that case, after producing a metal mold | die, the said metal mold | die is used as an original plate, a duplicate plate is formed, and the target acicular body may be produced using the said duplicate plate. Such duplicates are also within the scope of the present invention.

  A method for producing a needle-like body using a duplicate plate can be performed, for example, as follows. Please refer to FIG. A mold 31 having a desired protrusion shown in FIG. Next, the duplicate plate material 32 is filled in the mold 31 and is transferred and molded (FIG. 3B). After the duplicate plate material 32 is cured, the duplicate plate 33 is peeled from the mold 31. The obtained duplicated plate 33 has a recess which is a portion corresponding to the protrusion. The replica plate 33 is filled with the needle-shaped body forming material 34 (FIG. 3C). The protrusions are transferred and molded on the needle-shaped body forming material 34 and cured (FIG. 3D), and peeled from the duplicate plate 33 (FIG. 3E). As a result, a needle-like body 35 having a projection group 38 including a desired projection 37 and a flat portion 39 surrounding the projection group 38 on the first surface of the substrate 36 is obtained. The needle-like body 35 according to the present invention is characterized in that the shortest distance from the bottom surface of the protrusion 37 located on the outermost periphery of the protrusion group 38 to the outer periphery of the flat portion 39 is larger than the height of the protrusion 37. Accordingly, the substrate 36 may be cut in the region of the flat portion 39 if it has such a feature.

  Moreover, the acicular body according to the present invention may be manufactured using a multi-faced replica, that is, a multi-face replica. Please refer to FIG. The multi-sided replicated plate 41 includes a plurality of concave portions 42, a flat portion 44 that surrounds each concave portion group 42, and a margin 46 between adjacent flat portions 44. One recess group 42 includes a plurality of recesses 43 corresponding to the protrusions provided on the needle-like body and a region corresponding to the region therebetween. The flat portion 44 is a region corresponding to the flat portion provided in the needle-like body, and is a protrusion portion located on the outermost periphery of the protrusion group from the outer edge portion of the first surface of the substrate provided in the needle-like body. It corresponds to the area up to the bottom surface, that is, the portion of the substrate outside the protrusion group of the needle-like body. Here, the “outer edge portion of the first surface of the substrate” means a boundary between the first surface of the substrate having the protrusion and another surface adjacent thereto. By using such a multi-sided copy plate 41, a plurality of needle-like bodies can be simultaneously transferred and molded.

  The production of a needle-shaped body using a multi-sided replicated plate will be described with reference to FIGS. 4B to 4E, which are cross-sectional views taken along line III-III in FIG. First, the multi-face replication plate 41 is filled with a needle-shaped body molding material 47 (FIG. 4B). Next, the needle-shaped body molding material 47 is molded and cured (FIG. 4C). The cured needle-shaped body molding material 48 is peeled off from the duplicate plate 41 (FIG. 4D). Cut at a position corresponding to the cutting margin 46. Thereby, the acicular body 52 according to the present invention is obtained (FIG. 4E).

  The replication plate material used in the present invention may be selected from materials that take into account the shape following ability to transfer the original mold, transferability in transfer processing molding, durability, and releasability. For example, a high molecular compound such as an elastomer such as a urethane resin or a silicone resin may be used. Further, for example, a metal material such as nickel, an aluminum alloy, a copper alloy, or an iron alloy may be used. Although not limited to this, for example, a silicone resin can be used, and in this case, it can be suitably used as an inexpensive and low-risk material. Further, in order to remove impurities in the replication material, the replication plate material may be purified before being used in the transfer molding process.

  In addition, heating and / or cooling may be carried out in order to control the curing speed when making a duplicate plate, and the heating temperature and heating time, and the cooling temperature and cooling time are selected according to the properties of the duplicate plate material used. do it.

  In the duplicate plate manufacturing step, a defoaming step may be performed before filling the mold with the duplicate plate material in order to improve reproducibility in a fine region. A known defoaming method may be used for the defoaming step. For example, a defoaming method such as vacuum defoaming, centrifugal degassing, and stirring defoaming may be used.

  The needle-shaped body material used in the present invention may be the above-described needle-shaped body material.

  The method for filling the replica material with the needle-shaped body molding material is not limited to this, but from the viewpoint of productivity, the imprint method, hot embossing method, injection molding method, extrusion molding method and casting method are suitable. It is preferable to use for.

  In order to improve the releasability of the replication plate, a release layer for increasing the release effect may be formed on the surface of the replication plate before filling the needle-shaped body forming material. As the release layer, for example, a widely known fluorine-based resin can be used. Moreover, as a method for forming the release layer, a thin film forming method such as a PVD method, a CVD method, a spin coating method, or a dip coating method can be suitably used. By applying the release layer, it is possible to provide the needle-like body having a fine protrusion and the protrusion more stably.

  The cutting margin may be ensured as much as necessary for cutting in order to obtain a target needle-like body from the needle-like body group obtained by the multi-face replication plate. Therefore, it may be arranged depending on the type of needle-shaped body forming material and the cutting method.

  In addition, the above-described multi-sided copy version is also provided as the present invention. In addition, the duplicate plate according to the present invention is not limited to multi-page imposition, and may be a single-layer copy. Further, the multi-sided duplicated plate according to the present invention may be one in which two needle-like bodies are formed simultaneously as shown in FIG. 4, or may be one in which three or more needle-like bodies can be simultaneously formed. Such duplicates are also within the scope of the present invention.

  By using duplicate plate transfer molding, productivity is improved, and needles of the same shape can be produced at low cost and in large quantities.

  As mentioned above, although the example of the aspect of the acicular body according to this invention, the manufacturing method of a acicular body, a metal mold | die, and a duplicated plate was demonstrated, these are not limited to the said aspect, Even if it adds various changes. Good. In the case of the method according to the present invention, any step may be replaced with any replaceable step known per se, and further steps may be added. Such an embodiment is also included in the scope of the present invention.

  The needle-shaped body of the present invention is characterized in that the shortest distance from the bottom surface of the protrusion portion located on the outermost periphery of the protrusion group to the outer periphery of the flat portion is larger than the height of the protrusion portion. Preferably, the shortest distance from the bottom surface of the protruding portion located on the outermost periphery of the protruding portion group to the outer periphery of the flat portion is constant over the entire outer peripheral portion of the needle-like body. According to such a configuration of the present invention, a force that is generated when the needle-like body is pressed against the thin film and is pulled in an oblique direction from the deformed thin film applied to the protrusion located around the outer periphery of the protrusion group is provided to the protrusion. The substrate portion which is equivalent to the flat portion having a width larger than the height of the substrate portion relaxes and makes such a force uniform over the protrusion portions included in the protrusion portion group. Thereby, it becomes possible to suppress the destruction and deformation of the protrusion due to the force applied at the time of puncturing without deteriorating the puncturing performance.

3. Example Hereinafter, the example of the manufacturing method of the acicular body of this invention is demonstrated. Naturally, the manufacturing method of the acicular body of the present invention is not limited to the following examples, and includes other manufacturing methods that can be analogized. Moreover, the acicular body of the present invention is not limited to the acicular body produced in the following example.

Example 1
<Production of mold>
First, using precision machining, a total of 100 regular quadrangular pyramidal protrusions (height: 150 μm, bottom surface: 60 μm × 60 μm) are arranged in a 10-column, 10-row grid pattern on a silicon substrate. The acicular body to comprise was formed. The 100 protrusions were arranged in a square region having a side of about 9 mm.

  Next, a nickel conductive layer having a thickness of 100 nm was formed on the obtained needle-like body by sputtering. This conductive layer becomes a seed layer in the subsequent electrolytic plating. Next, a nickel film having a thickness of 500 μm was formed on the seed layer by electrolytic plating. Next, wet etching was performed using a 30% by weight potassium hydroxide aqueous solution heated to 90 ° C. to completely remove the silicon substrate. As a result, a mold 10 made of nickel as shown in FIG.

<Needle transfer molding>
Next, as shown in FIG. 2 (a), protrusions are formed on the polylactic acid by thermal imprinting using the sheet-like needle-shaped body forming material 13 made of polylactic acid having a thickness of about 400 μm and the mold 10. Was transferred and molded. Next, the cured acicular body molding material 13 is peeled off from the mold 10, so that the acicular body 15 made of polylactic acid having the substrate 18, the protrusion 14, and the flat portion 17 as shown in FIG. Got. The obtained needle-like body 15 has, on a square substrate 18 having a side of about 18 mm, protrusions 14 of regular square pyramids (height: 150 μm, bottom surface: 60 μm × 60 μm) in 10 columns and 10 rows at 1 mm intervals. A total of 100 grids were arranged and included. The 100 protruding portion groups 16 were arranged in a square region having a side of about 9 mm and located substantially at the center on the square substrate 18 having a side of about 18 mm. The distance 20 from the bottom surface of the protrusion 14 located on the outermost periphery of the protrusion group 16 of the needle-like body 15 to the outer periphery of the flat portion 17 is the first surface including the protrusion 14 of the needle-like body 15. It was about 4.5 mm in the whole surface. This was confirmed to be sufficiently larger than 150 μm, which is the height 21 of the protrusion 14. As described above, the acicular body according to the present invention was obtained.

Example 2
First, in the same manner as in Example 1, on a square substrate 18 having a side of about 18 mm, protrusions 14 having regular square pyramids (height: 150 μm, bottom surface: 60 μm × 60 μm) are arranged at 10 mm rows and 10 rows at 1 mm intervals. A plurality of needle-like bodies 15 provided in a total of 100 in the shape of a grid were prepared. The 100 protruding portion groups 16 were arranged in a square region having a side of about 9 mm and located substantially at the center on the square substrate 18 having a side of about 18 mm. The distance 20 from the bottom surface of the protrusion 14 located on the outermost periphery of the protrusion group 16 to the outer periphery of the flat portion was about 4.5 mm over the entire surface.

  Next, as shown in FIG. 2D, in order to adjust the distance from the bottom surface of the protrusion 14 located on the outermost periphery of the protrusion group 16 to the outer periphery of the flat portion, the substrate 18 is flattened by a laser cutter. As shown in FIG. 2 (e), the shortest distances 20 from the bottom surface of the protrusion 14 located on the outermost periphery of the protrusion group to the outer periphery of the flat portion are about 50 μm and about 150 μm, respectively. A needle-like body 19 having a size of about 500 μm and about 4.5 mm (without laser cutting) was produced.

  In addition, the first surface of the substrate of one needle-like body has four sides, but for each side, the shortest distance from the bottom surface of the protruding portion located on the outermost periphery of the protruding portion group to the outer periphery of the flat portion. The needles with different distances were produced in the same manner as described above. That is, after the protrusion 14 was transferred to the needle-shaped body molding material 13 using the mold 10, cured, and peeled, the substrate 18 of the obtained needle-shaped body 15 was laser-cut in the region of the flat portion 17. Laser cutting is performed so that the shortest distance of the needle-like body is about 50 μm on the first side, about 150 μm on the second side, and about 500 μm on the third side, and the fourth side is about without being cut. It was 4.5 mm.

  These samples were pressed by a load tester against a PET film (thickness: about 100 μm) placed on a silicone resin film (thickness: about 1 mm) having a rubber hardness of 50 degrees with a load of 1 MPa.

  The sample after the load test was observed with an optical microscope, and the damage and deformation of the protrusion were confirmed. As a result, in the sample having a distance from the bottom surface of the protrusion located on the outermost periphery of the protrusion group to the outer periphery of the flat part is about 50 μm, all 36 protrusions positioned on the outermost periphery of the protrusion group are damaged or Deformation was confirmed. In the sample having a distance of about 150 μm from the bottom surface of the projecting portion located on the outermost periphery of the projecting portion group to the outer periphery of the flat portion, the 36 projecting portions located on the outermost periphery of the projecting portion group are not damaged. Only a slight deformation was confirmed. In the sample having a distance from the protrusion located on the outermost periphery of the protrusion group to the outer periphery of the flat part of about 500 μm and about 4.5 μm, the 36 protrusions located on the outermost periphery of the protrusion group are also damaged. No deformation was confirmed.

  According to a similar load test and optical microscope observation performed on a needle-like body in which the shortest distance from the bottom surface of the protruding portion located on the outermost periphery of the protruding portion group to the outer periphery of the flat portion is changed for each side, the shortest distance is about 50 μm. It was confirmed that the protrusions were broken and deformed only on the protrusions arranged along the sides. No damage or deformation was observed on the protrusions located along the other sides.

Example 3
A needle-like body was produced in the same manner as in Example 1 except that the height of the protrusion and the shortest distance from the bottom surface of the protrusion located on the outermost periphery of the protrusion group to the outer periphery of the flat portion were changed. In other words, a needle-like body in which 100 square pyramidal protrusions (height: 600 μm, bottom surface: 240 μm × 240 μm) are arranged on a silicon substrate at intervals of 1 mm in a 10-column, 10-row grid, A mold 10 was produced from the needle-shaped body, and then a needle-shaped body 15 was formed from the mold 10. The obtained needle-like body 15 has, on a square substrate 18 having a side of about 18 mm, protrusions 14 of regular square pyramids (height: 600 μm, bottom surface: 240 μm × 240 μm) in 10 columns and 10 rows at 1 mm intervals. 100 lines were arranged in a lattice pattern. The projecting portion group 16 composed of the 100 projecting portions 14 was disposed in a square region having a side of about 9 mm and located substantially at the center on the square substrate 18 having a side of about 18 mm. The shortest distance 20 from the protrusion 14 located on the outermost periphery of the protrusion group 16 of the needle-like body 15 to the outer periphery of the flat portion was about 4.5 mm over the entire surface.

  Next, the region of the flat portion 17 of the substrate 18 of the needle-like body 15 is cut by laser cutting, and the distance 20 from the protruding portion 14 located on the outermost periphery of the protruding portion group to the outer periphery of the flat portion 17 is about 200 μm, about 600 μm. The needle-like body 19 having a diameter of about 2 mm and about 4.5 mm (without laser cutting) was produced. Similarly, laser cutting is performed, and the shortest distance from the protruding portion located on the outermost periphery of the protruding portion group in which the four sides constituting the first surface of the needle-like substrate are different for each side to the outer periphery of the flat portion That is, needles having about 200 μm, about 600 μm, about 2 mm, and about 4.5 mm were prepared. These samples were pressed by a load tester against a PET film (thickness: about 100 μm) placed on a silicone resin film (thickness: about 1 mm) having a rubber hardness of 50 degrees with a load of 1 MPa.

  The sample after the load test was observed with an optical microscope, and the damage and deformation of the protrusion were confirmed. As a result, in the sample having the shortest distance from the bottom surface of the protrusion located on the outermost periphery of the protrusion group to the outer periphery of the flat portion of about 200 μm, 16 of the 36 protrusions positioned on the outermost periphery of the protrusion group. In addition, damage or deformation was confirmed. Samples having a distance from the bottom surface of the protrusion located on the outermost periphery of the protrusion group to the outer periphery of the flat part of about 600 μm, about 2 mm, and about 4.5 μm include 36 samples positioned on the outermost periphery of the protrusion group. No damage or deformation was observed on the protrusion.

  Further, in the case of a needle-like body having different lengths of the shortest distances on the four sides of the first surface of the substrate, as a result of the same load test and observation with an optical microscope, a protrusion positioned on the outermost periphery of the protrusion group Only the protrusions arranged along the side where the distance from the bottom of the part to the outer periphery of the flat part is about 200 μm, the damage and deformation of the protrusions are confirmed, and the protrusions located along the other sides Neither breakage nor deformation was confirmed.

The needle-shaped body of the present invention is not only a needle-shaped body for transdermal administration, but also medical, drug discovery, cosmetics, MEM.
It can be used as a needle-like body having fine protrusions used in various fields such as S devices.

The figure which shows an example of the aspect according to this invention. The figure which shows an example of the aspect according to this invention. The figure which shows an example of the aspect according to this invention. The figure which shows an example of the aspect according to this invention.

Explanation of symbols

1, 13, 15, 19, 35, 51 ... acicular body 2, 11, 18, 36, 49, 52 ... substrate 3, 14, 37, 53 ... protrusion 4, 16, 38, 50 ... Projection part group 5, 17, 39, 44... Flat part 6, 20... Shortest distance between the outer periphery of the flat part and the bottom surface of the projection part located at the outermost periphery of the projection part group. 10, 31 ...... Mold 12, 43 ...... Recess 13, 47 ...... Needle-shaped body molding material 48 ...... Hardened needle-shaped body molding material 32 ...... Duplicated plate material 33, 41 ...... Duplicated version 34 ...... Formation Material 42 ...... concave group 46 ...... cutting

Claims (5)

A needle-like body comprising a substrate, a projection group formed on the first surface of the substrate, and a flat portion surrounding the projection, and a bottom surface of the projection located on the outermost periphery of the projection group A needle-like body, characterized in that the shortest distance from the outer periphery of the flat part to the outer periphery of the flat part is larger than the height of the protrusion. 2. The shortest distance from the bottom surface of the protruding portion located on the outermost periphery of the protruding portion group to the outer periphery of the flat portion is constant in a region along the outermost periphery of the protruding portion group. The acicular body described. 3. A plate for manufacturing the needle-shaped body according to claim 1, wherein the substrate, a recess group formed on the first surface of the substrate, and a flat surface surrounding the recess group are formed. A plate comprising: a recess, wherein a shortest distance from an opening of a recess located on the outermost periphery of the recess group to an outer periphery of the flat portion is greater than a depth of the recess. 3. A multi-face plate for producing the needle-shaped body according to claim 1, wherein the substrate, a plurality of recess groups formed on the first surface of the substrate, and the recess groups are formed. Each of the flat portions surrounding each of the flat portions, and a margin between adjacent flat portions, and the shortest distance from the opening of the concave portion located on the outermost periphery of the concave group to the outer periphery of the flat portion is the depth of the concave portion. A multi-sided version characterized by being larger than the size. A plate for manufacturing the acicular body according to any one of claims 1 and 2, comprising: a substrate; a protrusion group formed on a first surface of the substrate; and the protrusion group. A plate comprising an encircling flat portion, wherein the shortest distance from the bottom surface of the projecting portion located on the outermost periphery of the projecting portion group to the outer periphery of the flat portion is larger than the height of the projecting portion.

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