JP6846560B2 - Fine hollow protrusion - Google Patents

Description

The present invention relates to a fine hollow protrusion.

In recent years, in the medical field or the beauty field, the supply of agents by microneedles has attracted attention. By puncturing the shallow layer of skin, the microneedles can be painlessly as good as the supply of a syringe. Among the microneedles, the microneedles having a perforated portion are effective because they can expand the choice of agents to be arranged inside the microneedles. When a microneedle having a perforated portion is used particularly in the medical field or the beauty field, it is required that the pain when puncturing the skin can be reduced as much as possible and that it is hard to break.

Examples of the microneedles having the perforated portion include the microneedles described in Patent Documents 1 and 2. Patent Document 1 describes a microneedle having an inclined surface inclined at the tip end portion. Further, Patent Document 1 describes that a microneedle having an inclined surface at a tip portion is manufactured by a known injection molding technique as a method for manufacturing the microneedle.

Further, Patent Document 2 describes a hollow microneedle having a length of less than 1 mm and having an average channel hole having a cross-sectional area of 20 to 50 square μm. Further, in Patent Document 2, as a method for manufacturing a hollow microneedle having the average channel hole, a solid microneedle is manufactured by thermal cycle injection molding, and then the channel hole is formed by a laser drill to manufacture the hollow microneedle. Is described.

Japanese Unexamined Patent Publication No. 2014-176568 Special Table 2012-509106

However, in the manufacturing method by the known injection molding technique described in Patent Document 1, the wall thickness of the tip portion of the microneedle cannot be thinned, the tip portion cannot be sharpened, and when the skin is punctured. Difficult to reduce pain. Further, Patent Document 1 does not describe the relationship between the wall thickness on the tip side and the wall thickness on the root side, and does not describe anything about the difficulty of breaking.

Further, in the manufacturing method described in Patent Document 2, since a channel hole is formed by a laser drill after manufacturing a solid microneedle, a processing margin is required at the tip portion, and the tip portion cannot be sharpened. , It is difficult to reduce the pain when puncturing the skin. Further, as in Patent Document 1, Patent Document 2 does not describe the relationship between the wall thickness on the tip side and the wall thickness on the root side, and does not describe anything about the difficulty of breaking.

Therefore, the present invention is to provide a fine hollow protrusion having an open hole that can eliminate the above-mentioned drawbacks of the prior art.

In the present invention, the fine hollow protrusion having an opening on the tip side and having an internal space connected to the opening is a fine hollow protrusion protruding from the base member, and the fine hollow protrusion is formed. When any vertical cross section passing through the apex of the portion is viewed, the wall thickness at the apex side portion on the apex side is thinner than the wall thickness at the lower portion on the base member side than the apex side portion. The distance between the inner walls in the apex side portion is smaller than the distance between the inner walls in the lower side portion, the root portion of the fine hollow protrusion protruding from the base member has a curvature, and the fine hollow protrusion in the base member. It provides a fine hollow protrusion having a curvature at the entrance to the inside of the fine hollow protrusion on the opposite surface opposite to the protruding surface of the portion.

According to the present invention, pain can be reduced when the skin is punctured and the skin is not easily broken.

FIG. 1 is a schematic perspective view of a fine hollow protrusion according to a preferred embodiment of the fine hollow protrusion having an open portion of the present invention. FIG. 2 is a perspective view of a fine hollow protrusion tool focusing on one fine hollow protrusion shown in FIG. FIG. 3 is a cross-sectional view taken along the line III-III shown in FIG. FIG. 4 is a diagram showing an overall configuration of an embodiment of a manufacturing apparatus for manufacturing the fine hollow protrusions shown in FIG. 5 (a) to 5 (e) are views for explaining a process of manufacturing a fine hollow protrusion having a hole by using the manufacturing apparatus shown in FIG. FIG. 6 is an explanatory diagram showing a method of measuring the tip diameter and tip angle of the convex shape of the convex shape portion. FIG. 7 is a vertical cross-sectional view passing through the apex of the microhollow protrusion in the microhollow protrusion of the second embodiment of the microhollow protrusion having the perforated portion of the present invention (corresponding to FIG. 3).

Hereinafter, the fine hollow protrusion tool of the present invention will be described with reference to the drawings based on the fine hollow protrusion tool 1 which is the preferred first embodiment thereof. FIG. 1 shows a perspective view of the microneedle array 1M as the fine hollow protrusion 1 of the first embodiment. The microneedle array 1M of the first embodiment has a form in which a fine hollow protrusion 3 having an opening portion 3h on the distal end side and an internal space connected to the opening portion 3h is formed therein protrudes from the base member 2. It has become. In the first embodiment, the microneedle array 1M has a sheet-shaped base member 2 and a plurality of fine hollow protrusions 3, as shown in FIG. The number of the fine hollow protrusions 3, the arrangement of the fine hollow protrusions 3 and the shape of the fine hollow protrusions 3 are not particularly limited, but the microneedle array 1M of the first embodiment is preferably in the form of a sheet. Nine truncated cone-shaped fine hollow protrusions 3 are arranged on the upper surface of the base member 2. The nine fine hollow protrusions 3 arranged are three rows in the Y direction, which is the direction in which the base sheet 2A described later is conveyed (the vertical direction of the base member 2), the direction orthogonal to the transport direction, and the base member 2. They are arranged in three rows in the X direction, which is the horizontal direction of.

FIG. 2 is a perspective view of the microneedle array 1M focusing on one of the fine hollow protrusions 3 arranged in the microneedle array 1M. Further, FIG. 3 is a sectional view taken along line III-III shown in FIG. 2, which is a vertical sectional view passing through the apex of the fine hollow protrusion portion 3. Here, the apex of the fine hollow protrusion 3 is the case where the fine hollow protrusion 3 has an opening 3h at the tip on the tip side as in the microneedle array 1M of the first embodiment. It means the center of the opening portion 3h.

The microhollow protrusion 3 may have a hole 3h on the tip end side thereof, but in the microneedle array 1M of the first embodiment, as shown in FIGS. 2 and 3, a hole is opened at the tip thereof. It has a part 3h. Preferably, in the first embodiment, as shown in FIG. 3, the fine hollow protrusion 3 is formed with an internal space extending from the lower surface of the base member 2 to the opening 3h inside the fine hollow protrusion 3. An opening portion 3h is formed at the tip of the fine hollow protrusion portion 3. In the first embodiment, as shown in FIG. 3, the inner wall 31 forming the inside of the fine hollow protrusion 3 is formed in a straight line when the vertical cross section is viewed, and the outer wall 32 forming the outer shape is a straight line. It is formed in a shape. In the microneedle array 1M, the space inside the fine hollow protrusion 3 is formed in a shape corresponding to the outer shape of the fine hollow protrusion 3, and in the first embodiment, the truncated cone-shaped fine hollow protrusion 3 is formed. It is formed in a truncated cone shape corresponding to the outer shape of 3. The space inside the fine hollow protrusion 3 has a truncated cone shape in the first embodiment, but may have a truncated cone shape or the like in addition to the truncated cone shape.

In the microneedle array 1M, when a vertical cross section passing through the apex of the fine hollow protrusion 3 is viewed (see FIG. 3), the wall thickness T1 at the apex side portion TB on the apex side is larger than that at the apex side portion TB. It is thinner than the wall thickness T2 in the lower part BP on the base member 2 side, the distance M1 between the inner walls 31 and 31 in the apex side part TB is smaller than the distance M2 between the inner walls 31 and 31 in the lower part BP, and the base member. The root portion 34 of the fine hollow protrusion 3 protruding from 2 has a curvature, and the fine hollow of the back surface 25 which is the opposite surface to the front surface 24 which is the protruding surface of the fine hollow protrusion 3 in the base member 2. The entrance portion 23 into the protrusion portion 3 has a curvature. Here, the root portion 34 is a portion protruding from the base member 2, and in the microneedle array 1M of the present embodiment, the root portion 34 is a portion protruding from the surface 24 of the base member 2.
Preferably, the microneedle array 1M of the first embodiment has a truncated cone shape in the internal space and outer shape of the fine hollow protrusion 3, and has an opening 3h at the tip of the fine hollow protrusion 3. Therefore, in the microneedle array 1M, the wall thickness T1 of the apex side portion TB is the lower side portion regardless of the vertical cross section passing through the apex of the fine hollow protrusion 3 (the center of the opening 3h at the tip). It is thinner than the wall thickness T2 of the BP, and the distance M1 between the inner walls 31 and 31 in the apex side portion TB is smaller than the distance M2 between the inner walls 31 and 31 in the lower side portion BP. As described above, the wall thickness T1 of the apex side portion TB is thinner than the wall thickness T2 of the lower portion BP, and the distance M1 between the inner walls 31 and 31 in the apex side portion TB is between the inner walls 31 and 31 in the lower portion BP. Since the interval is smaller than M2, the microneedle array 1M can reduce pain when puncturing the skin and is hard to break.
Further, preferably, in the microneedle array 1M of the first embodiment, the root portion 34 of the fine hollow protrusion portion 3 protruding from the surface 24 of the base member 2 has a curved curve. Specifically, in the microneedle array 1M of the first embodiment, the root portion 34 of the fine hollow projection portion 3 on the surface 24 side of the base member 2 has a curved curve. In this way, the root portion 34 of the fine hollow protrusion portion 3 has a curvature, so that the structure is more difficult to break.
Further, preferably, in the microneedle array 1M of the first embodiment, the entrance portion 23 into the fine hollow protrusion portion 3 on the back surface 25 side of the base member 2 has a curved curve. As described above, since the entrance portion 23 into the fine hollow protrusion portion 3 on the back surface 25 side of the base member 2 has a curvature, the agent can easily flow when the agent is supplied.

When the internal space and the outer shape of the fine hollow protrusion 3 are formed in a pyramidal shape, the pyramid base is viewed when the vertical cross section passing through the apex of the fine hollow protrusion 3 in the microneedle array 1M is viewed. It is preferable that the position is excluding the corner of.

The microneedle array 1M of the first embodiment has a truncated cone-shaped internal space and outer shape of the fine hollow protrusions 3, and has an opening 3h at the tip of the fine hollow protrusions 3. Therefore, in the microneedle array 1M of the first embodiment, the inner peripheral shape formed by the inner wall 31 in the cross section of the apex side portion TB and the inner wall 31 formed by the inner wall 31 in the cross section of the lower side portion BP are formed. The shape is similar to the inner circumference. Further, in the microneedle array 1M, the outer peripheral shape formed by the outer wall 32 in the cross section of the apex side portion TB and the outer peripheral shape formed by the outer wall 32 in the cross section of the lower side portion BP have similar shapes. ing. Since it is formed in this way, the microneedle array 1M is more difficult to break. Further, as described above, in the microneedle array 1M of the first embodiment, as shown in FIG. 2, the space inside the microhollow protrusion 3 and the outer shape are formed in a truncated cone shape, so that the apex side is formed. The circular shape formed by the inner wall 31 in the cross section of the portion TB and the circular shape formed by the inner wall 31 in the cross section of the lower portion BP are formed concentrically. Since it is formed in this way, the microneedle array 1M is more difficult to break.

Further, the microneedle array 1M is formed by the perpendicular line IL passing through the apex and the outer wall 32 of the fine hollow protrusion 3 when the vertical cross section passing through the apex of the fine hollow protrusion 3 is viewed (see FIG. 3). The angle θ2 is larger than the angle θ1 formed by the perpendicular line IL and the inner wall 31 of the fine hollow protrusion 3. Preferably, in the microneedle array 1M of the first embodiment, the space inside the microhollow protrusion 3 and the outer shape are formed in a truncated cone shape, and the microhollow protrusion 3 has a hole 3h at the tip of the microhollow protrusion 3. Therefore, in the microneedle array 1M, the angle formed by the perpendicular line IL passing through the apex and the outer wall 32 regardless of the vertical cross section passing through the apex of the fine hollow protrusion 3 (the center of the opening 3h at the tip). θ2 is larger than the angle θ1 formed by the perpendicular line IL and the inner wall 31. Due to this formation, the microneedle array 1M can further reduce pain when puncturing the skin. In addition, the agent easily flows when the agent is supplied by the microneedle array 1M.

The ratio of the angle θ2 between the perpendicular IL and the outer wall 32 to the angle θ1 between the perpendicular IL and the inner wall 31 (θ2 / θ1) from the viewpoint of reducing pain when puncturing the skin and making it easier to supply the agent. Is preferably 0.03 or more, more preferably 0.1 or more, and more preferably 90 or less, further preferably 45 or less, specifically 0.03. It is preferably 90 or more, and more preferably 0.1 or more and 45 or less. Preferably, the formed angle θ1 is preferably 0.5 degrees or more, more preferably 2.5 degrees or more, and preferably 30 degrees or less, and preferably 22.5 degrees or less. More preferably, more preferably 0.5 degree or more and 30 degrees or less, and even more preferably 2.5 degrees or more and 22.5 degrees or less. Further, the formed angle θ2 is preferably 1 degree or more, more preferably 3 degrees or more, more preferably 45 degrees or less, further preferably 30 degrees or less, and specifically. Is preferably 1 degree or more and 45 degrees or less, and more preferably 3 degrees or more and 30 degrees or less. The formed angles θ1 and θ2 are observed by magnifying a vertical cross section passing through the apex of the fine hollow protrusion 3 with a scanning electron microscope (SEM) or a microscope at a predetermined magnification.

Further, in the microneedle array 1M, when a vertical cross section passing through the apex of the fine hollow protrusion 3 is viewed (see FIG. 3), the perpendicular line IL passing through the apex is formed on the inner walls 31, 31 of the apex side portion TB. It passes through the apex side center position M1c that bisects the distance M1 between each other and the lower center position M2c that bisects the distance M2 between the inner walls 31 and 31 in the lower side portion BP. Preferably, the microneedle array 1M of the first embodiment has a truncated cone-shaped internal space and outer shape of the fine hollow protrusions 3, and has an opening 3h at the tip of the fine hollow protrusions 3. Therefore, in the microneedle array 1M, the perpendicular line IL passing through the apex is the center position on the apex side regardless of the vertical cross section passing through the apex of the fine hollow protrusion 3 (the center of the opening 3h at the tip). It passes through M1c and the lower center position M2c. Since it is formed in this way, the microneedle array 1M is more difficult to break.

Further, in the microneedle array 1M of the first embodiment, the wall thickness T1 at the apex side portion TB is uniformly formed over the entire circumference. Preferably, the microneedle array 1M of the first embodiment has an opening portion 3h at the tip of the fine hollow protrusion portion 3, and the internal space and outer shape of the fine hollow protrusion portion 3 are formed in a truncated cone shape. Therefore, at the tip of the microneedle array 1M, the inner circumference formed by the inner wall 31 and the outer circumference formed by the outer wall 32 are each circular. Therefore, the wall thickness T1t at the tip, in other words, the distance between the inner circumference of the circular shape and the outer circumference of the circular shape is evenly formed over the entire circumference. Since it is formed in this way, the microneedle array 1M is more difficult to break.

Each of the fine hollow protrusions 3 of the microneedle array 1M of the first embodiment has a protrusion height H1 that penetrates the tip of the microneedle array 1M to the stratum corneum at the shallowest point and to the dermis at the deepest point, and is therefore preferably 0.01 mm. The above is more preferably 0.02 mm or more, preferably 10 mm or less, further preferably 5 mm or less, specifically preferably 0.01 mm or more and 10 mm or less, still more preferably 0. It is 02 mm or more and 5 mm or less.
Each microhollow protrusion 3 of the microneedle array 1M of the first embodiment is preferably 0.001 mm or more, more preferably 0, from the viewpoint that the wall thickness T1t at the tip thereof can reduce pain when puncturing the skin. It is .003 mm or more, preferably 0.005 mm or less, more preferably 0.1 mm or less, specifically, preferably 0.001 mm or more and 0.1 mm or less, still more preferably 0. It is 003 mm or more and 0.05 mm or less.
Each of the fine hollow protrusions 3 of the microneedle array 1M of the first embodiment has a wall thickness T1c at a position that bisects the protrusion height H1 so as to reduce pain when puncturing the skin and to prevent breakage. Therefore, it is preferably 0.001 mm or more, more preferably 0.003 mm or more, and preferably 0.1 mm or less, further preferably 0.05 mm or less, specifically, preferably 0.001 mm. It is 0.1 mm or more, and more preferably 0.003 mm or more and 0.05 mm or less.
Each of the fine hollow protrusions 3 of the microneedle array 1M of the first embodiment is preferably 0.004 mm or more from the viewpoint that the wall thickness T2b at the position of the upper surface of the base member 2 is hard to break when puncturing the skin. More preferably 0.008 mm or more, preferably 0.4 mm or less, further preferably 0.25 mm or less, specifically preferably 0.004 mm or more and 0.4 mm or less, and further. It is preferably 0.008 mm or more and 0.25 mm or less.

The tip diameter L (distance between the outer walls 32, 32 at the tip) of each of the fine hollow protrusions 3 of the microneedle array 1M is preferably 1 μm or more, more preferably 5 μm or more, and preferably 500 μm. It is less than or equal to, more preferably 300 μm or less, specifically preferably 1 μm or more and 500 μm or less, and further preferably 5 μm or more and 300 μm or less. The tip diameter L of the fine hollow protrusion 1 is the length at the widest position at the tip of the fine hollow protrusion 3. Within this range, there is almost no pain when the microneedle array 1M is inserted into the skin. The tip diameter L is measured as follows.

[Measurement of tip diameter of micro hollow protrusion 3 of microneedle array 1M]
When the tip of the fine hollow protrusion 3 is open, the tip of the fine hollow protrusion 3 is magnified by a predetermined magnification using a scanning electron microscope (SEM) or a microscope (FIG. 3A). (See), for example, by observing with an SEM image.
Next, assuming that the tip of the fine hollow protrusion 3 is present, the virtual straight line ILa is extended along the straight line portion on one side side 1a of the side sides 1a and 1b forming the outer wall 32, and the virtual straight line ILa is extended on the other side side 1b. The virtual straight line ILb is extended along the straight line portion, and the intersection thereof is set as the apex of the fine hollow protrusion portion 3. Next, on the tip side, a point where one side 1a is separated from the virtual straight line ILa is obtained as a first tip point 1a1, and a point where the other side 1b is separated from the virtual straight line ILb is obtained as a second tip point 1b1. The length L of the straight line connecting the first tip point 1a1 and the second tip point 1b1 obtained in this way was measured using a scanning electron microscope (SEM) or a microscope, and the length of the straight line was measured. Is the tip diameter of the fine hollow protrusion 3. When the tip of the fine hollow protrusion 3 is not open, a portion where one side side 1a is separated from the virtual straight line ILa is obtained as a first tip point 1a1, and a portion where the other side side 1b is separated from the virtual straight line ILb is obtained. It is determined as the second tip point 1b1, and the tip diameter is measured by the method described above.

The thickness T2 of the base member 2 is preferably 0.01 mm or more, more preferably 0.02 mm or more, and preferably 1.0 mm or less, further preferably 0.7 mm or less. Is preferably 0.01 mm or more and 1.0 mm or less, and more preferably 0.02 mm or more and 0.7 mm or less.

As shown in FIG. 3, the fine hollow protrusions 1 have an opening portion 3h located at the tip of each fine hollow protrusion 3 and a base side located on the lower surface of a base member 2 corresponding to each fine hollow protrusion 3. It has an opening portion 2h. In the microneedle array 1M of the first embodiment, the opening portion 3h and the basal side opening portion 2h are formed concentrically.
Further, the entrance portion 23 to the fine hollow protrusion portion 3 on the back surface 25 side of the base member 2 and the root portion 34 of the fine hollow protrusion portion 3 on the front surface 24 side of the base member 2 have a curved curve. Since the inlet portion 23 to the fine hollow protrusion portion 3 has a curvature, it becomes easy to flow when the agent is supplied. The root portion 34 of the fine hollow protrusion portion 3 has a curvature, so that the structure is more difficult to break.
The ratio (R1 / H1) of the protrusion height H1 of the fine hollow protrusion 3 to the radius of curvature R1 of the curve in which the root 34 of the fine hollow protrusion 3 on the surface 24 side of the base member 2 has a curvature is 0. It is preferably 0.01 or more, more preferably 0.02 or more, more preferably 0.5 or less, further preferably 0.3 or less, and specifically, 0.02 or more. It is preferably 01 or more and 0.5 or less, and more preferably 0.02 or more and 0.3 or less because it is easier to realize the ease of flow during agent supply and the difficulty of breaking the fine hollow portion. ..
Further, the ratio (R2 / H1) of the protrusion height H1 of the fine hollow protrusion 3 to the radius of curvature R2 of the curve in which the entrance portion 23 into the fine hollow protrusion 3 on the back surface 25 side of the base member 2 has a curvature. Is preferably 0.01 or more, more preferably 0.02 or more, more preferably 0.4 or less, still more preferably 0.25 or less, and specifically, It is preferably 0.01 or more and 0.4 or less, and 0.02 or more and 0.25 or less is because it becomes easier to realize the ease of flow at the time of agent supply and the difficulty of breaking the fine hollow portion. More preferred.
Further, the radius of curvature R1 of the root portion 34 of the fine hollow protrusion 3 on the front surface 24 side is smaller than the radius of curvature R2 of the entrance portion 23 of the fine hollow protrusion 3 on the back surface 25 side, so that the skin is pierced. It is preferable because sometimes the fine hollow protrusion 3 is hard to break and easily pierces.

^{The opening area S1 of the opening portion 3h is preferably 0.7 μm 2} or more, more preferably 20 μm ² or more, and preferably 20 μm 2 or more, from the viewpoint of easy supply of the agent by the microneedle array 1M. is a 200000Myuemu ² or less, still more preferably 70000Myuemu ² or less, specifically, preferably at 0.7 [mu] m ² or more 200000Myuemu ² or less, still more preferably 20 [mu] m ² or more 70000Myuemu ² or less.
From the same viewpoint, the basal opening area S2 has an opening area S2 of ^{preferably 0.007 mm 2} or more, more preferably 0.03 mm ² or more, and preferably 20 mm ² or less. even more preferably 7 mm ² or less, specifically, it is preferably at 0.007 mm ² or more 20 mm ² or less, more preferably at 0.03 mm ² mm or more 7 mm ² or less.

The nine fine hollow protrusions 3 arranged on the upper surface of the sheet-shaped base member 2 have a uniform center-to-center distance in the vertical direction (Y direction) and a uniform center-to-center distance in the horizontal direction (X direction). It is preferable that the distance between the centers in the vertical direction (Y direction) and the distance between the centers in the horizontal direction (X direction) are the same. Preferably, the distance between the centers of the fine hollow protrusions 3 in the vertical direction (Y direction) is preferably 0.01 mm or more, more preferably 0.05 mm or more, and preferably 10 mm or less, further preferably. Is 5 mm or less, specifically, preferably 0.01 mm or more and 10 mm or less, and more preferably 0.05 mm or more and 5 mm or less. The distance between the centers of the fine hollow protrusions 3 in the lateral direction (X direction) is preferably 0.01 mm or more, more preferably 0.05 mm or more, and preferably 10 mm or less, further preferably 5 mm. Specifically, it is preferably 0.01 mm or more and 10 mm or less, and more preferably 0.05 mm or more and 5 mm or less.

Next, the method for manufacturing the fine hollow protrusions of the present invention will be described with reference to FIGS. 4 to 6 by taking the above-mentioned method for manufacturing the microneedle array 1M as the fine hollow protrusions 1 as an example. FIG. 4 shows the overall configuration of the manufacturing apparatus 100 of one embodiment used for carrying out the manufacturing method of this embodiment. As described above, each of the fine hollow protrusions 3 of the microneedle array 1M is very small, but for convenience of explanation, in FIG. 4, each of the fine hollow protrusions 3 of the microneedle array 1M is very large. It is drawn.

The manufacturing apparatus 100 of the present embodiment shown in FIG. 4 has a protrusion precursor forming portion 10A for forming a hollow fine hollow protrusion precursor 3b (see FIG. 5) in the base sheet 2A and a fine hollow in the base sheet 2A. It includes a protrusion forming portion 10B for forming the protrusion 3, a cooling portion 20, and a release portion 30 for extracting a convex portion 11 described later.
In the following description, the direction in which the base sheet 2A is conveyed (the vertical direction of the base sheet 2A) is the Y direction, the direction orthogonal to the direction in which the base sheet 2A is conveyed, and the lateral direction of the base sheet 2A to be conveyed are the X directions. The thickness direction of the base sheet 2A will be described as the Z direction.

As shown in FIG. 4, the protrusion precursor forming portion 10A and the protrusion forming portion 10B include a convex portion 11 having a heating means (not shown). The convex portion 11 has a convex portion 110 corresponding to the number and arrangement of the fine hollow protrusions 3 of the microneedle array 1M to be manufactured and the substantially outer shape of each of the fine hollow protrusions 3, and is manufactured according to the present embodiment. The device 100 has nine truncated cone-shaped convex 110s corresponding to the nine truncated cone-shaped fine hollow protrusions 3. In the present specification, the convex portion 11 is a member provided with the convex portion 110 which is a portion to be pierced by the base material sheet 2A, and the convex portion 11 is a disk-shaped base in the manufacturing apparatus 100 of the present embodiment. It has a structure arranged on the part. However, the present invention is not limited to this, and the convex portion may be a convex portion composed of only the convex 110, or the convex portion 11 in which a plurality of convex 110s are arranged on the trapezoidal support.

Further, in the manufacturing apparatus 100 of the present embodiment, the amount of heat given from the convex portion 11 to the base sheet 2A by the protrusion forming portion 10B is increased from the convex portion 11 to the base sheet 2A by the protrusion precursor forming portion 10A. It is larger than the amount of heat given to. Here, the amount of heat given to the base sheet 2A means the amount of heat given to the base sheet 2A per unit insertion height. Specifically, the amount of heat given from the convex portion 11 to the base sheet 2A by the protrusion forming portion 10B is larger than the amount of heat given from the convex portion 11 to the base sheet 2A by the protruding portion precursor forming portion 10A. As a condition, (condition a) regarding the insertion speed of the convex portion 11 into the base material sheet 2A, the insertion speed of the protrusion forming portion 10B is higher than the insertion speed of the protrusion precursor forming portion 10A. (Condition b) When the heating means (not shown) of the convex portion 11 is an ultrasonic vibrating device, the frequency of the ultrasonic waves of the convex portion 11 of the protrusion forming portion 10B is the protrusion precursor. When the frequency is higher than the ultrasonic frequency of the convex portion 11 of the body forming portion 10A, and (condition c) the heating means (not shown) of the convex portion 11 is an ultrasonic vibration device, the protruding portion forming portion 10B The amplitude of the ultrasonic waves of the convex portion 11 of the above is larger than the amplitude of the ultrasonic waves of the convex portion 11 of the protrusion precursor forming portion 10A, (condition d) the heating means of the convex portion 11 (not shown). Is a heating heater, at least one condition is that the heater temperature of the convex portion 11 of the protrusion forming portion 10B is higher than the heater temperature of the convex portion 11 of the protrusion precursor forming portion 10A. It means that it meets. In the manufacturing apparatus 100 of this embodiment, no heating means is provided other than the heating means (not shown) of the convex portion 11. In the present specification, "there is no heating means other than the heating means of the convex portion 11" means not only the case where the other heating means is completely excluded, but also the temperature lower than the softening temperature of the base sheet 2A. It also includes a case where a means for heating to a temperature lower than the glass transition temperature is preferably provided. Specifically, as long as the temperature of the base sheet 2A applied by the heating means of the convex portion 11 is equal to or higher than the softening temperature of the base sheet 2A, there may be other heating below the softening temperature. Further, as long as the temperature of the base sheet 2A applied by the heating means of the convex portion 11 is equal to or higher than the glass transition temperature and lower than the softening temperature, other heating below the glass transition temperature may exist. However, it is preferable that no other heating means other than the heating means provided on the convex portions 11A and 11B is included. In the manufacturing apparatus 100 of the present embodiment, the heating means (not shown) of the convex portion 11 is an ultrasonic vibration apparatus.

In the present embodiment, first, the strip-shaped base sheet 2A is unwound from the raw fabric roll of the base sheet 2A formed by containing the thermoplastic resin, and is conveyed in the Y direction. Then, when the base sheet 2A is sent to a predetermined position, the transport of the base sheet 2A is stopped. As described above, in the present embodiment, the strip-shaped base sheet 2A is intermittently transported.

The base material sheet 2A is a sheet that serves as a base member 2 of the microneedle array 1M to be manufactured, and is formed by containing a thermoplastic resin. The base sheet 2A is mainly composed of a thermoplastic resin, that is, preferably contains 50% by mass or more, and more preferably 90% by mass or more of a thermoplastic resin. Examples of the thermoplastic resin include polyfatty acid esters, polycarbonates, polypropylenes, polyethylenes, polyesters, polyamides, polyamideimides, polyetheretherketones, polyetherimides, polystyrenes, polyethylene terephthalates, polyvinyl chlorides, nylon resins, acrylic resins and the like, or these. From the viewpoint of biodegradability, a polyfatty acid ester is preferably used. Specific examples of the polyfatty acid ester include polylactic acid, polyglycolic acid, and combinations thereof. The base sheet 2A may be formed of a mixture containing hyaluronic acid, collagen, starch, cellulose, etc., in addition to the thermoplastic resin. The thickness of the base sheet 2A is equivalent to the thickness T2 of the base member 2 of the microneedle array 1M to be manufactured.

Next, in the present embodiment, as shown in FIGS. 5 (a) and 5 (b), the convex portion 11 is brought into contact with the one surface 2D of the strip-shaped base material sheet 2A conveyed in the Y direction to form a base. While the contact portion TP of the material sheet 2A is softened by heat, the convex portion 11 is pierced into the base sheet 2A so as to protrude from the other surface 2U of the base sheet 2A and the tip of the base sheet 2A on the other surface 2U side. A hollow fine hollow protrusion precursor 3b having an opening portion 3h penetrating the hole 3b is formed (protrusion precursor forming step). Preferably, in the manufacturing apparatus 100 of the present embodiment, nine conical convex portions 110 having sharp tips are arranged on the convex portions 11 with their tips facing upward, and the convex portions 11 are arranged. , At least it can move up and down in the thickness direction (Z direction). More preferably, in the manufacturing apparatus 100 of the present embodiment, the convex portion 11 can be moved up and down in the thickness direction (Z direction) by an electric actuator (not shown). The operation (electric actuator) of the convex portion 11 is controlled by a control means (not shown) provided in the manufacturing apparatus 100 of the present embodiment. It is preferable that the heating means (not shown) of the convex portion 11 is operated from immediately before the convex portion 11 comes into contact with the base sheet 2A until immediately before the cooling step described later.
Controlling the heating conditions of the heating means (not shown) included in the convex portion 11 such as the operation of the convex portion 11 and the operation of the heating means (not shown) of the convex portion 11 is provided in the manufacturing apparatus 100 of the present embodiment. It is controlled by the control means (not shown).

The outer shape of the convex 110 of the convex portion 11 is sharper than the outer shape of the fine hollow protrusion 3 of the microneedle array 1M. The convex 110 of the convex portion 11 has a height H2 (see FIG. 4) formed higher than the height H1 of the manufactured microneedle array 1M, and is preferably 0.01 mm or more, more preferably 0.01 mm or more. Is 0.02 mm or more, preferably 30 mm or less, more preferably 20 mm or less, specifically, preferably 0.01 mm or more and 30 mm or less, still more preferably 0.02 mm or more and 20 mm or less. Is.
The convex shape 110 of the convex shape portion 11 has a tip diameter D1 (see FIG. 6) of preferably 0.001 mm or more, more preferably 0.005 mm or more, and preferably 1 mm or less, still more preferably. It is 0.5 mm or less, specifically, preferably 0.001 mm or more and 1 mm or less, and more preferably 0.005 mm or more and 0.5 mm or less. The tip diameter D1 of the convex shape 110 of the convex shape portion 11 is measured as follows.
The convex 110 of the convex portion 11 has a root diameter D2 (see FIG. 6) of preferably 0.1 mm or more, more preferably 0.2 mm or more, and preferably 5 mm or less, still more preferably. It is 3 mm or less, specifically, preferably 0.1 mm or more and 5 mm or less, and more preferably 0.2 mm or more and 3 mm or less.
The convex shape 110 of the convex shape portion 11 has a tip angle α (see FIG. 6) of preferably 1 degree or more, more preferably 5 degrees or more, from the viewpoint that sufficient strength can be easily obtained. The tip angle α is preferably 60 degrees or less, more preferably 45 degrees or less, and specifically preferably 1 degree or more and 60, from the viewpoint of obtaining the fine hollow protrusions 3 having an appropriate angle. The degree is less than or equal to, and more preferably 5 degrees or more and 45 degrees or less. The tip angle α of the convex shape 110 of the convex shape portion 11 is measured as follows.

[Measurement of tip diameter of convex 110 of convex portion 11]
The tip of the convex 110 of the convex portion 11 is observed in a state of being magnified to a predetermined magnification using a scanning electron microscope (SEM) or a microscope. Next, as shown in FIG. 6, the virtual straight line ILc is extended along the straight line portion on one side side 11a of the side surfaces 11a and 11b, and the virtual straight line ILd is extended along the straight line portion on the other side side 11b. Then, on the tip side, a point where the one side side 11a is separated from the virtual straight line ILc is obtained as the first tip point 11a1, and a point where the other side side 11b is separated from the virtual straight line ILd is obtained as the second tip point 11b1. The length D1 of the straight line connecting the first tip point 11a1 and the second tip point 11b1 obtained in this way was measured using a scanning electron microscope (SEM), and the length of the measured straight line was measured as convex. The tip diameter of the mold 110 is used.

[Measurement of tip angle α of convex 110 of convex portion 11]
The tip of the convex 110 of the convex portion 11 is observed in a state of being magnified to a predetermined magnification using a scanning electron microscope (SEM) or a microscope. Next, as shown in FIG. 6, the virtual straight line ILc is extended along the straight line portion on one side side 11a of the side surfaces 11a and 11b, and the virtual straight line ILd is extended along the straight line portion on the other side side 11b. Then, the angle formed by the virtual straight line ILc and the virtual straight line ILd is measured using a scanning electron microscope (SEM), and the measured angle is defined as the tip angle α of the convex shape 110 of the convex shape portion 11.

The convex portion 11 is made of a high-strength material that is hard to break. Examples of the material of the convex portion 11 include steel, stainless steel, aluminum, aluminum alloy, nickel, nickel alloy, cobalt, cobalt alloy, copper, copper alloy, beryllium copper, beryllium copper alloy and other metals, ceramics and the like. ..

In the manufacturing apparatus 100 of the present embodiment, the protrusion precursor forming portion 10A is a support member 12 that supports the base sheet 2A when the convex portion 11 is pierced into the base sheet 2A, as shown in FIG. have. The support member 12 is arranged on the other surface 2U side of the base sheet 2A, and plays a role of making the base sheet 2A less likely to bend when the convex portion 11 is inserted from the one surface 2D. Therefore, the support member 12 is arranged in a portion other than the region where the convex portion 11 of the base sheet 2A is inserted, and in the manufacturing apparatus 100 of the present embodiment, the base sheet 2A is conveyed in the transport direction (Y direction). It is formed of a pair of plate-shaped members extending parallel to the transport direction (Y direction) on both side portions along the above. Each support member 12 is arranged up to a protrusion precursor forming portion 10A, a protrusion forming portion 10B, a cooling portion 20, and a release portion 30.

The material for forming the support member 12 may be the same material as that of the convex portion 11, or may be formed of a synthetic resin or the like.

In the protrusion precursor forming step of the present embodiment, as shown in FIG. 4, the strip-shaped base sheet 2A is unwound from the original roll and conveyed in the Y direction, and is arranged on the other surface 2U side (upper surface side). A pair of support members 12 and 12 support both side portions of the base sheet 2A along the transport direction (Y direction). Then, each of the convex portions 11 is formed on a portion of the base sheet 2A that is not supported by the support member 12, that is, on one surface 2D (lower surface) of the central region between the pair of support members 12 and 12 on the base sheet 2A. The tip of the convex 110 is brought into contact with the tip. As described above, in the protrusion precursor forming step, the other surface 2U (upper surface) corresponding to the contact portion TP of the base sheet 2A to which each convex shape 110 of the convex shape portion 11 is brought into contact forms the protrusion portion. The convex portion 11 is not provided with a concave portion or the like for fitting the convex portion 11, and is in a floating state.

Then, in the present embodiment, as shown in FIG. 5A, in each contact portion TP, ultrasonic vibration of the convex portion 11 is generated by the ultrasonic vibration device, and heat due to friction is applied to the contact portion TP. It is generated to soften the contact portion TP. Then, in the protrusion precursor forming step of the present embodiment, as shown in FIG. 5 (b), one surface 2D (lower surface) to the other surface 2U (upper surface) of the base sheet 2A is softened while each contact portion TP is softened. ), The convex portion 11 is raised toward the base sheet 2A, the tip of the convex portion 110 is pierced into the base sheet 2A, and the opening portion 3h is projected from the other surface 2U (upper surface) of the base sheet 2A and penetrates. The hollow fine hollow protrusion precursor 3b to have is formed.

In the step of forming the protrusion precursor of the present embodiment, regarding the ultrasonic vibration of the convex portion 11 by the ultrasonic vibration device, the vibration frequency (hereinafter referred to as “frequency”) is the fine hollow protrusion precursor having the opening portion 3h. From the viewpoint of the formation of 3b, it is preferably 10 kHz or more, more preferably 15 kHz or more, and preferably 50 kHz or less, further preferably 40 kHz or less, specifically, preferably 10 kHz or more and 50 kHz or less. More preferably, it is 15 kHz or more and 40 kHz or less.
Further, with respect to the ultrasonic vibration of the convex portion 11 by the ultrasonic vibration device, the amplitude thereof is preferably 1 μm or more, more preferably 5 μm or more, from the viewpoint of forming the fine hollow protrusion precursor 3b having the opening portion 3h. It is preferably 60 μm or less, more preferably 50 μm or less, specifically, preferably 1 μm or more and 60 μm or less, and further preferably 5 μm or more and 50 μm or less. When the ultrasonic vibration device is used as in the present embodiment, the frequency and amplitude of the ultrasonic vibration of the convex portion 11 may be adjusted within the above-mentioned range in the protrusion precursor forming step.

In the protrusion precursor forming step of the present embodiment, if the insertion speed at which the convex portion 11 is pierced into the base sheet 2A is too slow, the resin is excessively softened and the size of the opening portion 3h becomes too large. If the speed is too fast, the softening is insufficient and the opening portion 3h is not formed. Therefore, from the viewpoint of efficiently forming the fine hollow protrusion precursor 3b having the opening portion 3h, it is preferably 0.1 mm / sec or more, more preferably 0.1 mm / sec or more. It is 1 mm / sec or more, preferably 1000 mm / sec or less, more preferably 800 mm / sec or less, specifically preferably 0.1 mm / sec or more and 1000 mm / sec or less, further preferably. Is 1 mm / sec or more and 800 mm / sec or less.

In the protrusion precursor forming step of the present embodiment, the insertion height of the convex portion 11 to be pierced into the base sheet 2A is from the viewpoint of efficiently forming the fine hollow protrusion precursor 3b having the opening portion 3h. It is preferably 0.001 mm or more, more preferably 0.01 mm or more, and preferably 2 mm or less, further preferably 1 mm or less, and specifically preferably 0.001 mm or more and 2 mm or less. More preferably, it is 0.01 mm or more and 1 mm or less. Here, the "insertion height" refers to the apex of the convex 110 of the convex portion 11 and the base sheet 2A in a state where the convex 110 of the convex portion 11 is inserted into the base sheet 2A. It means the distance from the surface 2U. Therefore, the penetration height in the protrusion precursor forming step is the state in which the convex 110 is deeply pierced in the protrusion precursor forming step and the convex 110 comes out from the other surface 2U of the base sheet 2A. , The distance from the other surface 2U to the convex 110 apex measured in the vertical direction.

Next, in the manufacturing apparatus 100 of the present embodiment, as shown in FIG. 4, the protrusion forming portion 10B is installed next to the protrusion precursor forming portion 10A. In the present embodiment, after the protrusion precursor forming step, the contact portion TP in the base sheet 2A is softened by heat in a state where the convex portion 11 is inserted into the fine hollow protrusion precursor 3b. The convex portion 11 is further pierced into the base sheet 2A to form a fine hollow protrusion 3 protruding from the other surface 2U of the base sheet 2A for a longer distance (fine hollow protrusion forming step). Preferably, in the manufacturing apparatus 100 of the present embodiment, the convex portion 11 is further moved upward in the thickness direction (Z direction) by an electric actuator (not shown), and is convex inside each fine hollow protrusion precursor 3b. With the convex shape 110 of the mold portion 11 inserted, each contact portion TP in the base sheet 2A is subjected to ultrasonic vibration of the convex portion 11 by an ultrasonic vibration device, and the contact portion TP is rubbed. The convex 110 of the convex portion 11 is further pierced into the base sheet 2A while further softening by generating heat to form a fine hollow protruding portion 3 that further protrudes from the other surface 2U of the base sheet 2A. In the process of forming the fine hollow protrusions of the present embodiment, as shown in FIG. 4, a pair of support members 12 and 12 arranged on the other surface 2U side (upper surface side) of the strip-shaped base material sheet 2A is used as a base. Both side portions of the material sheet 2A along the transport direction (Y direction) are supported.

In the microhollow protrusion forming step of the present embodiment, as shown in FIG. 5C, the frequency and amplitude of the ultrasonic vibration of the convex portion 11 by the ultrasonic vibrating device are set in the protrusion precursor forming step, respectively. It is the same as the frequency and amplitude of ultrasonic vibration. The opening area of the opening portion 3h of the fine hollow protrusion portion 3 formed in the fine hollow protrusion formation step is the opening area 3h of the fine hollow protrusion precursor 3b formed in the protrusion precursor forming step. Although the area is equal to or larger than the opening area S1, it is preferable that the area is the same as the opening area S1.

In the fine hollow protrusion forming step of the present embodiment, the insertion speed at which the convex portion 11 is pierced into the base sheet 2A is such that the convex portion 11 is pierced into the base sheet 2A in the protrusion precursor forming step. It is slower than the insertion speed. In the process of forming the fine hollow protrusions of the present embodiment, if the insertion speed at which the convex portion 11 is pierced into the base sheet 2A is too slow, the resin is excessively softened and the size of the opening portion 3h changes significantly. If it is too fast or too fast, the softening will be insufficient and the height of the fine hollow protrusion 3 will be insufficient. Therefore, from the viewpoint of efficiently forming the fine hollow protrusion 3 having the opening 3h, it is preferably 0.1 mm / sec or more. More preferably 1 mm / sec or more, and preferably 1000 mm / sec or less, further preferably 800 mm / sec or less, specifically, preferably 0.1 mm / sec or more and 1000 mm / sec or less. Yes, more preferably 1 mm / sec or more and 800 mm / sec or less.

In the fine hollow protrusion forming step of the present embodiment, after the fine hollow protrusion precursor 3b having the opening portion 3h is formed in the protrusion precursor forming step, the rise of the convex portion 11 is reduced at a constant acceleration. Then, the ascending of the convex portion 11 in the heated state is stopped. Since the rise of the convex portion 11 is reduced at a constant acceleration in this way, the wall thickness T1 of the apex side portion TB is thinner than the wall thickness T2 of the lower portion BP, and the inner walls 31 and 31 in the apex side portion TB are thinned to each other. It is easy to manufacture a microneedle array 1M having a fine hollow protrusion 3 in which the interval M1 is smaller than the interval M2 between the inner walls 31 and 31 in the lower portion BP. Further, at this time, the inlet portion of the fine hollow protrusion 3 on the one side 2D side of the base sheet 2A and the root portion of the fine hollow protrusion 3 on the other side 2U side of the base sheet 2A have a curved curve. ..

In the step of forming the fine hollow protrusions of the present embodiment, the ascending of the convex portion 11 in the heated state is stopped, and the convex 110 of the convex portion 11 is pierced inside the fine hollow protrusions 3 in the next step. If the softening time, which is the time until the cooling step is performed, is too long, each contact portion TP in the base sheet 2A will be excessively softened, but from the viewpoint of compensating for the insufficient softening, it is preferably 0 seconds or more, and further. It is preferably 0.1 seconds or more, preferably 10 seconds or less, more preferably 5 seconds or less, specifically, preferably 0 seconds or more and 10 seconds or less, still more preferably 0. It is 1 second or more and 5 seconds or less.

In the process of forming the fine hollow protrusions of the present embodiment, the insertion height of the convex portion 11 to be pierced into the base sheet 2A is preferable from the viewpoint of efficiently forming the fine hollow protrusions 3 having the opening 3h. Is 0.01 mm or more, more preferably 0.02 mm or more, and preferably 10 mm or less, further preferably 5 mm or less, specifically, preferably 0.01 mm or more and 10 mm or less, and further. It is preferably 0.02 mm or more and 5 mm or less.

In the present embodiment, the conditions of the heating means (not shown) provided by the convex portion 11 in the protrusion precursor forming step and the conditions of the heating means (not shown) provided by the convex portion 11 in the fine hollow protrusion forming step. The speed at which the convex portion 11 is further pierced into the base sheet 2A in the process of forming the fine hollow protrusions is the same as that of the above, and the convex portion 11 is pierced into the base sheet 2A in the step of forming the protrusion precursor. It's slower than it goes. Specifically, in the manufacturing apparatus 100 of the present embodiment, the heating means (not shown) of the convex portion 11 is an ultrasonic vibration device, but the ultrasonic waves of the convex portion 11 included in the protrusion forming portion 10B. The frequency and amplitude of the vibration and the frequency and amplitude of the ultrasonic vibration of the convex portion 11 of the protrusion precursor forming portion 10A are the same, and the conditions (b) and (c) above are not satisfied. However, in the present embodiment, regarding the insertion speed of the convex portion 11 into the base sheet 2A, the insertion speed in the fine hollow protrusion forming step is slower than the insertion speed in the protrusion precursor forming step. The condition (a) is satisfied. Therefore, the amount of heat given from the convex portion 11 to the base sheet 2A in the process of forming the fine hollow protrusions becomes larger than the amount of heat given from the convex portion 11 to the base sheet 2A in the step of forming the protrusion precursor. There is.

Further, in the manufacturing apparatus 100 of the present embodiment, regarding the insertion speed of the convex portion 11 into the base sheet 2A, the insertion speed is continuously slowed from the protrusion precursor forming step to the fine hollow protrusion forming step. It has become. That is, the insertion speed is gradually reduced, and the rise of the convex portion 11 is reduced at a constant acceleration. Therefore, in the present embodiment, the amount of heat per unit insertion height given from the convex portion 11 to the base sheet 2A in the protrusion precursor forming step and from the convex portion 11 in the fine hollow protrusion forming step. The amount of heat per unit insertion height given to the base sheet 2A continuously changes from the latter half of the protrusion precursor forming step to the first half of the fine hollow protrusion forming step. The "heat amount per unit insertion height" is a value obtained by dividing the total heat amount applied to the base material sheet 2A by the moving distance of the convex portion 11 in each step. For example, in the protrusion precursor forming step, the total amount of heat given to the base sheet 2A from the time when the convex portion 11 comes into contact with the base sheet 2A until the end of the step is calculated by the total moving distance of the step. It is the value divided.

Next, in the manufacturing apparatus 100 of the present embodiment, as shown in FIG. 4, a cooling unit 20 is installed next to the protrusion forming unit 10B. As shown in FIG. 4, the cooling unit 20 includes a cold air blower 21. In the present embodiment, after the fine hollow protrusion forming step, the fine hollow protrusion 3 is cooled by using the cold air blower 21 in a state where the convex portion 11 is pierced inside the fine hollow protrusion 3 (cooling step). ). In the manufacturing apparatus 100 of the present embodiment, in the cold air blower 21, a blower port 22 (see FIG. 5D) for blowing cold air is arranged on the other surface 2U side (upper surface side) of the base sheet 2A. Cold air is blown from the air outlet 22 to cool the fine hollow protrusion 3. The cold air blower covers the entire other surface 2U side (upper surface side) and one surface 2D side (lower surface side) of the band-shaped base sheet 2A to be conveyed in a hollow shape, and the inside of the cold air blower is a band-shaped base. The material sheet 2A may be transported in the transport direction (Y direction), and for example, a blower port 22 for blowing cold air may be provided in the hollow. The control of the cooling temperature and the cooling time of the cold air blower 21 is controlled by the control means (not shown) provided in the manufacturing apparatus 100 of the present embodiment.

In the cooling step of the present embodiment, as shown in FIG. 5 (d), the convex shape 110 of the convex shape portion 11 is inserted into the fine hollow protrusion portion 3, and the other surface 2U side of the base sheet 2A is shown. Cold air is blown from the air outlet 22 arranged on the (upper surface side) to cool the inside of the fine hollow protrusion 3 with the convex 110 of the convex portion 11 pierced. When cooling, the ultrasonic vibration of the convex portion 11 by the ultrasonic device may be in a continuous state or a stopped state, but the shape of the fine hollow protrusion 3 is kept constant without being excessively deformed. From the viewpoint, it is preferable that it is stopped.

The temperature of the cold air to be blown is preferably −50 ° C. or higher, more preferably −40 ° C. or higher, and preferably 26 ° C. or lower, from the viewpoint of forming the fine hollow projection portion 3 having the opening portion 3h. More preferably, it is 10 ° C. or lower, specifically, preferably −50 ° C. or higher and 26 ° C. or lower, and further preferably −40 ° C. or higher and 10 ° C. or lower.
The cooling time for cooling by blowing cold air is preferably 0.01 seconds or more, more preferably 0.5 seconds or more, and preferably 60 seconds or less from the viewpoint of compatibility between moldability and processing time. More preferably, it is 30 seconds or less, specifically, preferably 0.01 seconds or more and 60 seconds or less, and further preferably 0.5 seconds or more and 30 seconds or less.

Next, in the manufacturing apparatus 100 of the present embodiment, as shown in FIG. 4, a release unit 30 is installed next to the cooling unit 20. In this embodiment, after the cooling step, the convex portion 11 is pulled out from the inside of the fine hollow protrusion portion 3 to form the precursor 1A of the microneedle array 1M (release step). Specifically, in the release step of the present embodiment, as shown in FIG. 5 (e), the convex portion 11 is lowered from one surface 2D (lower surface) of the base sheet 2A, and the inside of each fine hollow protrusion portion 3 is formed. From the state in which the convex shape 110 of the convex shape portion 11 is inserted into the convex shape portion 11, the convex shape 110 of the convex shape portion 11 is pulled out, and the fine hollow protrusion portions 3 having the opening portion 3h and having a hollow inside are arranged in an array. A precursor 1A of a band-shaped fine hollow protrusion to be a microneedle array 1M is formed.

The precursor 1A of the microneedle array 1M formed as described above is then transported to the downstream side in the transport direction (Y direction). After that, in the cutting step, the microhollow protrusion 1 according to the first embodiment is cut within a predetermined range and has a sheet-shaped base member 2 and a plurality of microhollow protrusions 3 as shown in FIG. A microneedle array 1M can be manufactured. By repeating the above steps, the fine hollow protrusion 1 can be continuously and efficiently manufactured on the other surface 2U side (upper surface side) of the base sheet 2A.

The microneedle array 1M manufactured as described above may be further formed into a predetermined shape in a subsequent step, or the base sheet 2A may be further formed into a desired shape before the step of inserting the convex portion 11. May be adjusted in advance.

As described above, according to the manufacturing method of the present embodiment in which the microneedle array 1M is manufactured by using the manufacturing apparatus 100, the wall thickness T1 of the apex side portion TB is thinner than the wall thickness T2 of the lower side portion BP. It is possible to accurately manufacture a microneedle array 1M having a fine hollow protrusion 3 in which the distance M1 between the inner walls 31 and 31 in the apex side portion TB is smaller than the distance M2 between the inner walls 31 and 31 in the lower side portion BP. ..

Next, the fine hollow protrusion tool of the present invention will be described with reference to FIG. 7 based on the fine hollow protrusion tool 1 of the second embodiment. FIG. 7 shows a cross-sectional view of the microneedle array 1M as the microhollow protrusion 1 of the second embodiment. In this description, the points different from the above-described first embodiment will be mainly described.

In the first embodiment, the outer wall 32 of the fine hollow protrusions 3 of the microneedle array 1M is formed in a straight line, but the microneedle array 1M of the second embodiment has the fine hollow protrusions 3. A step is provided on the outer wall 33 of the.
In the second embodiment, as shown in FIG. 7, the microneedle array 1M has a perpendicular line IL passing through the apex of the microhollow protrusion 3 when looking at any vertical cross section passing through the apex of the microhollow protrusion 3. The angle formed by the fine hollow protrusion 3 and the outer wall 33 of the fine hollow protrusion 3 is different between the top side and the base member side. Specifically, the outer wall 33 of the fine hollow protrusion 3 of the microneedle array 1M of the second embodiment is located on the top side, and is located on the top side outer wall 331 formed in a straight line and on the base member side. It has a two-stage structure with a base member side outer wall 332 formed in a straight line with an inclination different from the top side outer wall 331, and the angle θ4 formed by the perpendicular line IL and the base member side outer wall 332 is the perpendicular line IL and the top. It is larger than the angle θ3 formed by the side outer wall 331. That is, in the microhollow protrusion 3 of the microneedle array 1M of the second embodiment, the inner wall 31 is formed in a straight line, while the outer wall 33 is provided with a step. By forming in this way, in addition to being able to make the base member side thicker than the top side, the base member side can be made thicker toward the root, and the fine hollow protrusions can be made thicker. The part 3 can be made more difficult to break.

From the viewpoint of reducing pain when puncturing the fine hollow protrusion 3 into the skin and making it difficult for the fine hollow protrusion 3 to break, the vertical line IL and the top side outer wall with respect to the angle θ4 formed by the vertical line IL and the base member side outer wall 332. The ratio of the angle θ3 formed with 331 (θ3 / θ4) is preferably 0.05 or more, more preferably 0.1 or more, and preferably 0.6 or less. It is more preferably 5 or less, more specifically, 0.05 or more and 0.6 or less, and further preferably 0.1 or more and 0.5 or less.

Further, from the viewpoint of reducing pain when puncturing the fine hollow protrusions 3 into the skin and making it difficult for the fine hollow protrusions 3 to break, from the upper surface of the base member 2 to the step with respect to the protrusion height H1 of the microneedle array 1M. The ratio of the height H3 of (H3 / H1) is preferably 0.05 or more, more preferably 0.1 or more, and preferably 0.05 or less, 0.6. More preferably, it is more preferably 0.05 or more and 0.6 or less, and further preferably 0.1 or more and 0.5 or less.

The fine hollow protrusion 3 of the microneedle array 1M of the second embodiment is preferably 0.005 mm or more, and further, from the viewpoint that the wall thickness T1d at the step position can reduce pain when puncturing the skin and is hard to break. It is preferably 0.01 mm or more, preferably 0.5 mm or less, more preferably 0.3 mm or less, and specifically preferably 0.005 mm or more and 0.5 mm or less, further preferably. Is 0.01 mm or more and 0.3 mm or less.

The fine hollow protrusion 3 of the microneedle array 1M of the second embodiment is preferably 0.02 mm or more, and further, from the viewpoint that the wall thickness T2c at the position of the upper surface of the base member 2 is hard to break when puncturing the skin. It is preferably 0.01 mm or more, preferably 0.8 mm or less, more preferably 0.5 mm or less, and specifically, preferably 0.01 mm or more and 0.8 mm or less, further preferably. Is 0.02 mm or more and 0.5 mm or less.

In the second embodiment, the configuration in which one step is provided on the outer wall 33 of the fine hollow projection portion 3 has been described, but the outer wall 33 may be provided with two or more steps. That is, the inclination angle of the outer wall 33 may be gradually increased from the top side toward the base member side. For example, another outer wall having a larger slope than the top side outer wall 331 and a smaller slope than the base member side outer wall 332 may be provided between the top side outer wall 331 and the base member side outer wall 332.

Further, the microneedle array 1M of the second embodiment is in a state in which the convex portion 11 is inserted into the microhollow protrusion precursor 3b in the step of forming the fine hollow protrusion portion of the manufacturing method of the first embodiment. The convex portion 11 is further pierced into the base sheet 2A while the base sheet 2A is softened by heat to form a portion of the top side outer wall 331. After that, the portion of the base member side outer wall 332 can be formed by further inserting the convex portion 11 into the base material sheet 2A while giving a heat amount lower than the heat amount when forming the portion of the top side outer wall 331. In this way, after forming the portion of the top side outer wall 331, the convex portion 11 is temporarily stopped, and the insertion speed when forming the portion of the top side outer wall 331 while maintaining the same frequency and amplitude of the ultrasonic vibration The convex portion 11 is moved at a slower insertion speed to form the portion of the outer wall 332 on the base member side. That is, after forming the portion of the top side outer wall 331, the portion of the base member side outer wall 332 is formed.

The microhollow protrusions of the present invention have been described above based on the microneedle array 1M of the preferred embodiment, but the present invention is not limited to the above-described embodiment and can be appropriately modified.

For example, in the microneedle array 1M as the microhollow protrusion 1 of the above-described embodiment, nine truncated cone-shaped microhollow protrusions 3 are arranged on the upper surface of the sheet-shaped base member 2, but 1 It may have the fine hollow protrusions 3. Further, in the microneedle array 1M as the fine hollow protrusion 1 of the above-described embodiment, the opening 3h located at the tip of the fine hollow protrusion 3 and the base side opening 2h located at the lower surface have a concentric shape. However, it does not have to be concentric. That is, if the opening portion 3h of the fine hollow protrusion 1 is on the tip side of the fine hollow protrusion 3, it does not have to be at the tip.

Further, in the method of manufacturing the microneedle array 1M of the above-described embodiment, the ultrasonic vibration device is used as the heating means of the convex portion 11, but the heating means of the convex portion 11 can also be used as a heating heater device. Good.
When the heating means of the convex portion 11 is a heating heater device, in each contact portion TP, the convex portion 11 is heated by the heating heater device to generate heat in the contact portion TP to soften the contact portion TP. Let me. Then, in the protrusion precursor forming step, while softening each contact portion TP, the convex portion 11 is raised from one surface 2D (lower surface) of the base sheet 2A toward the other surface 2U (upper surface) to form a base. The tip of the convex 110 is pierced into the material sheet 2A to form a hollow fine hollow protrusion precursor 3b having an opening 3h that protrudes from the other surface 2U (upper surface) of the base sheet 2A and penetrates therethrough. .. The heating temperature of the base sheet 2A by the convex portion 11 is equal to or higher than the glass transition temperature (Tg) of the base sheet 2A used and lower than the melting temperature from the viewpoint of forming the fine hollow protrusion precursor 3b. It is preferable that the temperature is equal to or higher than the softening temperature of the resin and lower than the melting temperature. In the process of forming the fine hollow protrusions, in each contact portion TP, the convex portion 11 is heated at the same temperature as the protrusion precursor forming step by the heating heater device, and heat is generated in the contact portion TP to make contact. While softening the partial TP, the convex portion 11 is further raised from one surface 2D (lower surface) of the base sheet 2A toward the other surface 2U (upper surface), and the tip portion of the convex shape 110 is further pierced into the base sheet 2A. A fine hollow protrusion 3 having an opening 3h that further protrudes from the other surface 2U (upper surface) of the base sheet 2A is formed. In the process of forming the fine hollow protrusions, the piercing speed at which the convex portion 11 is pierced into the base sheet 2A is high, and in the step of forming the protrusion precursor, the convex portion 11 is pierced into the base sheet 2A. It is slower than the entry speed.

Further, for example, in the method of manufacturing the microneedle array 1M of the above-described embodiment, the frequency and amplitude of the ultrasonic vibration of the convex portion 11 included in the protrusion forming portion 10B and the convex portion of the protrusion precursor forming portion 10A. The frequency and amplitude of the ultrasonic vibration of the mold portion 11 are the same, and the conditions of (condition b) and (condition c) are not satisfied, but the insertion speed in the process of forming the fine hollow protrusion is higher than that of the protrusion. The insertion speed is slower than the insertion speed in the part precursor forming step, and the above condition (condition a) is satisfied. As a result, the amount of heat given from the convex portion 11 to the base sheet 2A in the fine hollow protrusion forming step is the protrusion. The amount of heat given from the convex portion 11 to the base sheet 2A in the precursor forming step is larger than the amount of heat given to the base sheet 2A.
That is, the method for manufacturing the microneedle array 1M according to the above-described embodiment includes the conditions of the heating means provided by the convex portion 11 in the protrusion precursor forming step and the convex portion 11 in the fine hollow protrusion forming step. The conditions of the heating means are the same, and the speed at which the convex portion 11 is further pierced into the base sheet 2A in the fine hollow protrusion forming step is such that the convex portion 11 is further pierced into the base sheet 2A in the protrusion precursor forming step. This is a manufacturing method that is slower than the speed at which the sheet 2A is pierced. However, the speed at which the convex portion 11 is further pierced into the base sheet 2A in the protrusion precursor forming step and the speed at which the convex portion 11 is further pierced into the base sheet 2A in the fine hollow protrusion forming step are different. It is the same, and the amount of heat applied to the base sheet 2A under the condition of the heating means provided by the convex portion 11 in the fine hollow protrusion forming step is the amount of heat given to the base sheet 2A in the protruding portion precursor forming step of the heating means provided by the convex portion 11. The manufacturing method may be larger than the amount of heat applied to the base sheet 2A under the conditions. Specifically, although the condition (condition a) is not satisfied, the frequency or amplitude of the ultrasonic vibration of the convex portion 11 of the protrusion forming portion 10B is higher than that of the protrusion precursor forming portion 10A. It is larger than the frequency or amplitude of the ultrasonic vibration of the convex portion 11, and satisfies the condition (condition b) or the above (condition c). As a result, the base material is formed from the convex portion 11 in the fine hollow protrusion forming step. The amount of heat given to the sheet 2A may be larger than the amount of heat given to the base sheet 2A from the convex portion 11 in the protrusion precursor forming step.

Similarly, in the manufacturing apparatus of the embodiment in which the heating means of the convex portion 11 is used as a heating heater device, the heater temperature of the convex portion 11 of the protrusion forming portion 10B and the convex shape of the protrusion precursor forming portion 10A. When the heater temperature of the part 11 is set to the same temperature, the condition (condition d) is not satisfied, but the penetration speed in the fine hollow protrusion forming step is higher than the penetration speed in the protrusion precursor forming step. By slowing down the heat, the condition (condition a) is satisfied, and as a result, the amount of heat given from the convex portion 11 to the base sheet 2A in the process of forming the fine hollow protrusions is convex in the step of forming the protrusion precursor. It is larger than the amount of heat given from the mold portion 11 to the base sheet 2A. Further, although the condition (condition a) is not satisfied, the heater temperature of the convex portion 11 of the protrusion forming portion 10B is higher than the heater temperature of the convex portion 11 of the protrusion precursor forming portion 10A. As a result, the amount of heat given from the convex portion 11 to the base sheet 2A in the fine hollow protrusion forming step is based on the convex portion 11 in the protruding precursor forming step. It may be larger than the amount of heat given to the material sheet 2A. Further, all of the above-mentioned (condition a) condition, the above-mentioned (condition b) condition, the above-mentioned (condition c) condition, and the above-mentioned (condition d) condition may be satisfied.

Further, in the method of manufacturing the microneedle array 1M according to the above-described embodiment, the convex portion 11 can be moved up and down in the thickness direction (Z direction) by an electric actuator (not shown), but the track is infinite. The box motion type convex portion 11 to be drawn may be used.
Further, in the method for manufacturing the microneedle array 1M of the above-described embodiment, as shown in FIG. 4, the convex portion 11 inserts the base sheet 2A downward or upward, but the base material The positional relationship between the convex portion and the support member with respect to the sheet and the insertion direction are not limited to this, and the microneedle array 1M may be formed from above to below.

Further, the following fine hollow protrusions are disclosed with respect to the above-described embodiment of the present invention.

<1>
The fine hollow protrusion having an opening on the tip side and having an internal space connected to the opening is a fine hollow protrusion protruding from the base member, and the apex of the fine hollow protrusion is formed. When looking at any of the vertical cross sections that pass through, the wall thickness at the apex side portion on the apex side is thinner than the wall thickness at the lower portion on the base member side than the apex side portion, and the wall thickness at the apex side portion is The distance between the inner walls is smaller than the distance between the inner walls in the lower portion, the root portion of the fine hollow protrusions protruding from the base member has a curvature, and the fine hollow protrusions in the base member protrude. A fine hollow protrusion having a curvature at the entrance to the inside of the fine hollow protrusion on the opposite surface to the surface.
<2>
The fine hollow projection tool according to <1>, wherein the wall thickness at the apex side portion is uniform over the entire circumference.
<3>
When a vertical cross section passing through the apex of the fine hollow protrusion is viewed, the angle θ2 formed by the vertical line passing through the apex and the outer wall of the fine hollow protrusion is the vertical line and the inner wall of the fine hollow protrusion. The fine hollow protrusion according to <1> or <2>, which is larger than the angle θ1 formed by the object.
<4>
The space inside the microhollow protrusion and the outer shape are formed in a truncated cone shape, and the angle between the vertical line passing through the apex and the outer wall is the vertical line regardless of the vertical cross section passing through the apex of the fine hollow protrusion. The fine hollow protrusion according to <3>, which is larger than the angle formed by the inner wall and the inner wall.
<5>
The ratio (θ2 / θ1) of the angle θ2 formed by the vertical line passing through the apex and the outer wall with respect to the angle θ1 formed by the vertical line passing through the apex and the inner wall is preferably 0.03 or more and 90 or less, more preferably 0. The fine hollow protrusion according to the above <3> or <4>, which is 1 or more and 45 or less.
<6>
The angle θ1 formed by the vertical line passing through the apex and the inner wall is preferably 0.5 degrees or more and 30 degrees or less, and more preferably 2.5 degrees or more and 22.5 degrees or less. > The fine hollow protrusion according to any one of>.
<7>
The angle θ2 formed by the vertical line passing through the apex and the outer wall is preferably 1 degree or more and 45 degrees or less, and more preferably 3 degrees or more and 30 degrees or less. The fine hollow protrusion described.
<8>
When a vertical cross section passing through the apex of the fine hollow protrusion is viewed, the perpendicular line passing through the apex is the apex side center position that bisects the distance between the inner walls at the apex side portion and the lower side. The fine hollow protrusion according to any one of <1> to <7>, which passes through a lower center position that bisects the distance between inner walls at a site.
<9>
The wall thickness of each fine hollow protrusion at the position of the upper surface of the base member is preferably 0.004 mm or more and 0.4 mm or less, and more preferably 0.008 mm or more and 0.25 mm or less. > The fine hollow protrusion according to any one of <8>.
<10>
When a vertical cross section passing through the apex of the fine hollow protrusion is viewed, the angle formed by the vertical line passing through the apex and the outer wall of the fine hollow protrusion differs between the apex side and the base member side. The fine hollow projection tool according to any one of <1> to <8>, wherein the angle formed by the base member side is larger than the angle formed by the apex side.
<11>
The ratio of the angle θ3 formed by the vertical line and the outer wall on the top side to the angle θ4 formed by the vertical line passing through the apex and the outer wall on the base member side is preferably 0.05 or more and 0.6 or less. The fine hollow projection tool according to <10>, which is more preferably 0.1 or more and 0.5 or less.
<12>
H3 / H1, which is the ratio of the height H3 from the upper surface to the step of the base member to the protruding height H1 of the fine hollow protrusion, is preferably 0.05 or more and 0.6 or less, and more preferably 0. The fine hollow protrusion according to the above <10> or <11>, which is 1 or more and 0.5 or less.
<13>
The thickness of the fine hollow protrusions at the step position is preferably 0.005 mm or more and 0.5 mm or less, and more preferably 0.01 mm or more and 0.3 mm or less. The fine hollow projection tool according to any one of.
<14>
The thickness of the fine hollow protrusions at the position of the upper surface of the base member is preferably 0.01 mm or more and 0.8 mm or less, and more preferably 0.02 mm or more and 0.5 mm or less. > To the fine hollow protrusion according to any one of <13>.
<15>
The fine hollow protrusion has a protrusion height of preferably 0.01 mm or more and 10 mm or less, more preferably 0.02 mm or more and 5 mm or less, according to any one of <1> to <14>. Fine hollow protrusion tool.
<16>
The thickness of the tip of the fine hollow protrusion is preferably 0.001 mm or more and 0.1 mm or less, and more preferably 0.003 mm or more and 0.05 mm or less. The fine hollow protrusion according to any one.
<17>
The thickness of the fine hollow protrusions at a position where the protrusion height is bisected is preferably 0.001 mm or more and 0.1 mm or less, and more preferably 0.003 mm or more and 0.05 mm or less. The fine hollow protrusion according to any one of <1> to <16>.
<18>
The fine hollow according to any one of <1> to <17>, wherein the tip diameter of the fine hollow protrusion is preferably 1 μm or more and 500 μm or less, and more preferably 5 μm or more and 300 μm or less. Protrusion tool.
<19>
The base member has a thickness of preferably 0.01 mm or more and 1.0 mm or less, more preferably 0.02 mm or more and 0.7 mm or less, according to any one of <1> to <18>. Fine hollow protrusions.
<20>
The ratio (R1 / H1) of the radius of curvature R1 of the radius of curvature R1 of the root portion of the fine hollow protrusions to the protrusion height H1 of the fine hollow protrusions in the base member is preferably 0.01 or more and 0.5 or less, more preferably 0. The fine hollow protrusion according to any one of <1> to <19>, which is 02 or more and 0.3 or less.
<21>
The ratio (R2 / H1) of the radius of curvature R2 of the entrance portion of the base member to the inside of the fine hollow protrusion on the opposite surface opposite to the protruding surface of the fine hollow protrusion to the protrusion height H1 of the fine hollow protrusion. ) Is preferably 0.01 or more and 0.4 or less, and more preferably 0.02 or more and 0.25 or less, according to any one of <1> to <20>.

1 Micro hollow protrusion (microneedle array)
2 Base member 2h Base side opening part 23 Entrance part 24 Surface (projecting surface of fine hollow protrusion)
25 Back side (opposite side)
3 Fine hollow protrusion 3h Opening part 31 Inner wall 32, 33 Outer wall 34 Root part 331 Top side outer wall 332 Base member side outer wall IL Perpendicular line TB Apex side part BP Lower side part M1 Spacing between inner walls in apex side part M1c Apex side part Lower center position that bisects the distance between inner walls in M2 Distance between inner walls in the lower part M2c Lower center position that bisects the distance between inner walls in the lower part T1 Thickness T2 in the apex side part Thickness at the side part θ1 Angle between the perpendicular and the inner wall θ2 Angle between the perpendicular and the outer wall θ3 Angle between the perpendicular and the outer wall on the top side θ4 Angle between the perpendicular and the outer wall on the base member side

Claims (6)

The fine hollow protrusion having an opening on the tip side and having an internal space connected to the opening is a fine hollow protrusion protruding from the base member.
When looking at any of the vertical sections passing through the apex of the fine hollow protrusion,
The wall thickness at the apex side portion on the apex side is thinner than the wall thickness at the lower portion on the base member side than the apex side portion, and the distance between the inner walls at the apex side portion is smaller than that between the inner walls at the lower portion. Less than the interval of
The root of the fine hollow protrusion protruding from the base member has a curvature.
The entrance portion of the base member on the opposite surface opposite to the projecting surface of the fine hollow protrusion into the fine hollow protrusion has a curvature.
The fine hollow protrusion is formed by containing 50% by mass or more of a thermoplastic resin.
The ratio (R1 / H1) of the radius of curvature (R1) of the root portion to the protrusion height (H1) of the fine hollow protrusion portion is 0.01 or more and 0.5 or less.
The ratio (R2 / H1) of the radius of curvature (R2) of the entrance portion to the protrusion height (H1) of the fine hollow protrusion portion is 0.01 or more and 0.4 or less.
The radius of curvature (R1) of the root portion is smaller than the radius of curvature (R2) of the entrance portion.
The fine hollow protrusion tool is a fine hollow protrusion tool used to supply an agent from the inside to the outside of the fine hollow protrusion portion. The fine hollow protrusion having an opening on the tip side and having an internal space connected to the opening is a fine hollow protrusion protruding from the base member.
When looking at any of the vertical sections passing through the apex of the fine hollow protrusion,
At a position in the height direction from the upper surface of the base member to the apex, the wall thickness at the apex side portion on the apex side is thinner than the wall thickness at the lower portion on the base member side than the apex side portion. The distance between the inner walls at the apex side portion is smaller than the distance between the inner walls at the lower portion.
The root of the fine hollow protrusion protruding from the base member has a curvature.
The entrance portion of the base member on the opposite surface opposite to the projecting surface of the fine hollow protrusion into the fine hollow protrusion has a curvature.
The internal space is truncated cone-shaped
The ratio (R1 / H1) of the radius of curvature (R1) of the root portion to the protrusion height (H1) of the fine hollow protrusion portion is 0.01 or more and 0.5 or less.
The ratio (R2 / H1) of the radius of curvature (R2) of the entrance portion to the protrusion height (H1) of the fine hollow protrusion portion is 0.01 or more and 0.4 or less.
The radius of curvature (R1) of the root portion is smaller than the radius of curvature (R2) of the entrance portion.
The fine hollow protrusion tool is a fine hollow protrusion tool used to supply an agent from the inside to the outside of the fine hollow protrusion portion. The fine hollow protrusion has a step on the outer wall and has a step.
When looking at any of the vertical sections passing through the apex of the fine hollow protrusion,
The outer wall includes a top side outer wall located on the apex side of the step and formed in a straight line, and a base member side outer wall located on the base member side of the step and formed in a straight line. The angle formed by the vertical line passing through the apex and the outer wall on the base member side is larger than the angle formed by the vertical line passing through the apex and the outer wall on the top side.
The fine hollow protrusion tool according to claim 1 or 2, wherein the inner wall of the fine hollow protrusion is linear. The fine hollow protrusion has the opening at the tip on the tip side thereof, and has the same height over the entire circumference of the top of the opening.
The fine hollow projection tool according to any one of claims 1 to 3, wherein the wall thickness at the opening end of the opened portion is 0.001 mm or more and 0.1 mm or less. The fine hollow projection tool according to claim 3 or 4, wherein the ratio of the angle formed by the apex side to the angle formed by the base member side is 0.6 or less. The fine hollow protrusion according to any one of claims 1 to 5, wherein the fine hollow protrusion contains 90% by mass or more of a thermoplastic resin.

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