JP2022011198A - Fine hollow protrusion tool - Google Patents

Abstract

To provide a fine hollow protrusion tool having an improved puncture property by suppressing crushing of a tip at the time of puncturing a skin.SOLUTION: In a fine hollow protrusion tool 1 in which a fine hollow protrusion part 3 having an internal space protrudes from a base part 2, when looking at any longitudinal cross-section where the hollow protrusion part 3 passes an apex P of the hollow protrusion part, and when a distance between outer surfaces 32 located in a width direction X1 orthogonal to a protrusion direction H of the hollow protrusion part is defined as an outer diameter r1, a distance between inner surfaces 31 located in the width direction is defined as an inner diameter r2, and a value of half the difference between the outer diameter and the inner diameter in a region where the inner diameter is larger than 0 is defined as a wall thickness T1, the inner diameter r2 increases continuously or discontinuously from the apex P side toward the base part 2. The hollow protrusion part 3 has, from the apex P side toward the base part 2 an upper thickness conversion part F1 in which the wall thickness shifts from an increase to a decrease and a lower thickness conversion part F2 in which the wall thickness shifts from a decrease to an increase. The lower thickness conversion part F2 is located on the base part side of the upper thickness conversion part F1.SELECTED DRAWING: Figure 4

Description

The present invention relates to a fine hollow protrusion.

In Patent Document 1, in a fine hollow projection tool in which a fine hollow protrusion having a space formed inside protrudes from a base member, any vertical cross section passing through the apex of the fine hollow protrusion is viewed, and the apex on the apex side is viewed. Disclosed is a fine hollow projection whose wall thickness at a side portion is thinner than that at a portion below the base member side of the apex side portion.

Japanese Unexamined Patent Publication No. 2017-176652

In the technique described in Patent Document 1, the wall thickness at the apex side portion on the apex side of the fine hollow protrusion is formed thinner than the wall thickness at the lower portion on the base member side than the apex side portion. The tip may be crushed when puncturing the skin, reducing punctureability.
Therefore, an object of the present invention is to provide a fine hollow protrusion that can eliminate the drawbacks of the above-mentioned prior art.

The present invention is a fine hollow protrusion having an internal space protruding from a base portion and being pierced by an object from the apex side of the hollow protrusion, wherein the hollow protrusion is the same. Looking at any vertical cross section passing through the apex of the hollow protrusion, the distance between the outer surfaces located in the width direction orthogonal to the protrusion direction of the hollow protrusion is the outer diameter, and the distance between the inner surfaces located in the width direction is the distance between the inner surfaces. When the inner diameter and half of the difference between the outer diameter and the inner diameter in the region where the inner diameter is larger than 0 are defined as the wall thickness, the inner diameter is continuous or discontinuous from the apex side toward the base portion. From the apex side to the base side, there is an upper thickness conversion part where the wall thickness changes from an increase to a decrease, and a lower thickness conversion part where the wall thickness changes from a decrease to an increase. However, the lower thickness conversion portion provides a fine hollow protrusion located closer to the base portion than the upper thickness conversion portion.

According to the present invention, it is possible to provide a fine hollow protrusion having improved punctureability by suppressing crushing of the tip when puncturing the skin.

FIG. 1 is a schematic perspective view of a microneedle array, which is an example of the fine hollow projection tool of the present invention. FIG. 2A is a perspective view showing a schematic configuration of one hollow protrusion, and FIG. 2B is a cut end view taken along the line AA shown in FIG. 2A. FIG. 3 is an explanatory diagram showing a method of measuring the tip diameter of the fine hollow protrusion. FIG. 4A is a vertical cut end view of the hollow protrusion of the fine hollow protrusion according to the present embodiment, and FIG. 4B is measurement of the outer diameter and the inner diameter at each height in the protruding direction of the outer diameter and the inner diameter. The figure which plotted the value, FIG. 4C is the figure which plotted the measured value of the wall thickness at each height in the protruding direction. FIG. 5 is a diagram showing a configuration example of a manufacturing apparatus for manufacturing the fine hollow protrusion shown in FIG. 1. FIG. 6 is an explanatory diagram showing a method of measuring the tip angle of the convex portion included in the manufacturing apparatus. FIG. 7 is a diagram illustrating a manufacturing process for manufacturing a fine hollow protrusion using the manufacturing apparatus shown in FIG. 8 (a) to 8 (e) are vertical cut end views of hollow protrusions formed with different ultrasonic amplitudes. FIG. 9A plots the measured values of the outer diameters of each hollow protrusion shown in FIG. 8, and FIG. 9B plots the measured values of the inner diameters of each hollow protrusion shown in FIG. 9 (c) is a diagram in which the measured values of the wall thickness of each hollow protrusion shown in FIG. 8 are plotted. It is a figure which shows the evaluation result of the puncture load evaluation test of a hollow protrusion. 11 (a) is a perspective view showing a hollow protrusion having a through hole, and FIG. 11 (b) is a cross-sectional end view taken along the line BB of FIG. 11 (a). FIG. 12 is a diagram showing an overall configuration of a manufacturing apparatus for manufacturing a fine hollow protrusion having a hollow protrusion having a through hole shown in FIG. FIG. 13 is a diagram showing the configuration of a plurality of hollow protrusions having through holes and the evaluation of a puncture evaluation experiment using these hollow protrusions. FIG. 14 is a diagram showing the relationship between the wall thickness of the hollow protrusion, the distance from the tip, and the tip collapse.

Hereinafter, the present invention will be described based on the preferred embodiment thereof with reference to the drawings.
FIG. 1 shows a perspective view of a microneedle array 1 (M), which is an example of a fine hollow protrusion 1. The microneedle array 1 (M) of the present embodiment has a sheet-shaped base portion 2 and a plurality of fine hollow protrusion portions 3. The plurality of hollow protrusions 3 are formed so as to project from the base portion 2. The number of hollow protrusions 3 and the arrangement of the hollow protrusions 3 are not particularly limited, but the microneedle array 1 (M) of the present embodiment preferably forms the upper surface of the sheet-shaped base portion 2. Nine substantially truncated cone-shaped hollow protrusions 3 are provided in an array (matrix) on the surface side 2U. The other surface side 2U is a surface opposite to the one surface side when the lower surface of the base portion 2 is the one surface side 2D. The nine hollow protrusions 3 arranged in an array (matrix) form three rows in the Y direction, which is the direction for transporting the base sheet 2A described later (longitudinal direction of the base sheet 2A), and are orthogonal to the transport direction. It is arranged in three rows in the X direction, which is the width direction of the base sheet 2A to be transported and the direction of the base sheet. In the present embodiment, the sheet-shaped base portion 2 is composed of a member containing a thermoplastic resin. The hollow protrusion 3 of the microneedle array 1 (M) is very small, but for convenience of explanation, the hollow protrusion 3 is drawn very large.
FIG. 2A is a perspective view showing a schematic configuration of one hollow protrusion 3 among the plurality of hollow protrusions 3 included in the microneedle array 1 (M), and FIG. 2B is a view. 2 (a) is a cross-sectional end view taken along the line AA. The hollow protrusions 3 shown in FIGS. 2A and 2B project from the base portion 2 in the protrusion direction H, and are punctured by the object from the apex P side of the hollow protrusions 3. Here, the object to be punctured by the hollow protrusion 3 is, for example, the skin.
The hollow protrusion 3 is erected on the other surface side 2U of the base portion 2. As shown in FIG. 2B, the hollow protrusion 3 has a space 3s (hereinafter referred to as “internal space 3s”) formed therein. Specifically, the internal space 3s is formed so as to penetrate the base portion 2 and reach the inside of the hollow protrusion portion 3.

When the fine hollow protrusion 1 has a protrusion height H1 (see FIG. 2 (b)) of the hollow protrusion 3 as a microneedle, the tip thereof is deeply extended to the stratum corneum of the skin at the shallowest point. Since it penetrates to the dermis, it is preferably 0.01 mm or more, more preferably 0.02 mm or more, and preferably 10 mm or less, further preferably 5 mm or less, and specifically, preferably 0. It is 01 mm or more and 10 mm or less, and more preferably 0.02 mm or more and 5 mm or less.

The protrusion height H1 is parallel to the other surface side 2U of the base portion 2 on which the hollow protrusion 3 is protruding, is orthogonal to the protrusion direction H, and is a virtual line P1 passing through the apex P of the hollow protrusion 3. It is the distance between the other side 2U. When the other surface side 2U is not a flat surface but a wavy uneven surface, between the virtual line P1 passing through the apex P and the virtual line connecting the tops of the convex portions of the other surface side 2U and parallel to the virtual line P1. The distance between the two may be the protruding height H1. The protrusion height H1 is the distance between the virtual line P1 and the other side 2U by drawing a virtual line P1 passing through the apex P in a state of being magnified by a predetermined magnification using, for example, a scanning electron microscope (SEM) or a microscope. It can be known by measuring.

In the present embodiment, the hollow protrusion 3 has a substantially tubular shape, and the outer surface 32 is located in the width direction X1 orthogonal to the protrusion direction H of the hollow protrusion 3 when viewed any vertical cross section passing through the apex P. The distance between 32 and 32 is defined as the outer diameter r1, and the distance between the inner surfaces 31 and 31 located in the width direction X1 is defined as the inner diameter r2. In the present embodiment, the value of half the difference between the outer diameter r1 and the inner diameter r2 in the region where the inner diameter is larger than 0 is defined as the wall thickness T1. As shown in FIG. 2B, when the cross-sectional shape of the hollow protrusion 3 is symmetrical with respect to the perpendicular line G passing through the apex P in the vertical cross section to be observed, each of the protrusion directions H of the hollow protrusion 3 is observed. At the position, the value obtained by subtracting the distance between the inner surface 31 and the perpendicular line G from the distance between the outer surface 32 and the perpendicular line G is equated with the value of half the difference between the outer diameter r1 and the inner diameter r2, and the wall thickness T1. It can also be the value of. For example, in the present embodiment, the wall thickness T1 is the distance from the perpendicular line G passing through the apex P to the inner surface 31 on one side and one side in a state where the wall thickness T1 is magnified by a predetermined magnification using, for example, a scanning electron microscope (SEM) or a microscope. It can be measured by measuring the distances to the outer surface 32 at the same height and calculating the value of half of the difference between the outer diameter r1 and the inner diameter r2 obtained by doubling each measured value.
The base portion 2 has a thickness T2 from the other surface side 2U to the lower surface side 2D, preferably 0.01 mm or more, more preferably 0.02 mm or more, and preferably 1.0 mm or less. It is more preferably 0.7 mm or less, specifically, preferably 0.01 mm or more and 1.0 mm or less, and further preferably 0.02 mm or more and 0.7 mm or less. The thickness T2 is the thickness of the base sheet 2A.

The tip diameter of the hollow protrusion 3 is preferably 0.001 mm or more, more preferably 0.005 mm or more, and preferably 0.5 mm or less, still more preferably 0.3 mm or less. Specifically, it is preferably 0.001 mm or more and 0.5 mm or less, and more preferably 0.005 mm or more and 0.3 mm or less. The tip diameter of the hollow protrusion 3 of the fine hollow protrusion 1 is measured as follows.

The tip of the hollow protrusion 3 is observed using a scanning electron microscope (SEM) or a microscope in a state of being magnified at a predetermined magnification, for example, as shown in the SEM image shown in FIG. Next, as shown in FIG. 3, the virtual straight line ILa is extended along the straight line portion on one side side 1a of the side sides 1a and 1b, and the virtual straight line ILb is extended along the straight line portion on the other side side 1b. Then, on the tip side, a point where one side 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 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 hollow protrusion 3.

In the present embodiment, since the fine hollow protrusion 1 has a plurality of hollow protrusions 3, the tip diameter of the hollow protrusion 3 is set, but the fine hollow protrusion 1 has one hollow protrusion 3 and a base portion 2. When configured from, the tip diameter of the hollow protrusion 3 can be said to be the tip diameter of the fine hollow protrusion 1.
FIG. 4A is a vertical cross section of the hollow protrusion 3 according to the present embodiment, and FIG. 4B is a measurement of the outer diameter r1 and the inner diameter r2 at each height in the protruding direction H of the outer diameter r1 and the inner diameter r2. The figure which plotted the value, FIG. 4C is the figure which plotted the measured value of the wall thickness T1 at each height in the protrusion direction H. In FIGS. 4 (b) and 4 (c), the vertical axis indicates the distance from the apex P to the other surface side 2U of the base portion 2 (distance along the protrusion direction H), and the horizontal axis is the dimension in the width direction X1. Is shown.
In the fine hollow protrusion 1 according to the present embodiment, as shown in FIG. 4B, the inner diameter r2 of the hollow protrusion 3 continuously increases from the apex P side toward the base portion 2. The fine hollow protrusion 1 has an upper thickness conversion portion F1 in which the wall thickness changes from an increase to a decrease and a lower thickness conversion portion F2 in which the wall thickness changes from a decrease to an increase from the apex P side to the base portion 2. is doing. More specifically, the upper thickness conversion portion F1 is located on the apex P side of the lower thickness conversion portion F2, and the lower thickness conversion portion F2 is located on the base portion 2 side of the upper thickness conversion portion F1. The upper thickness conversion portion F1 has a function of ensuring the rigidity of the hollow protrusion portion 3 at the time of puncturing the skin.

When extremely minute unevenness is present on the inner or outer surface of the hollow protrusion 3, the relationship between the position of the hollow protrusion 3 in the protruding direction H and the wall thickness T1 is measured even for a minute change in the wall thickness due to the unevenness. A large number of irregularities will occur in the relational curve showing. The upper thickness conversion portion F1 and the lower thickness conversion portion F2 ignore such minute irregularities and determine their existence and existence position from the schematic shape of the relational curve. For example, when the protrusion H1 of the hollow protrusion 3 is 1 mm, even if there is a partial thickness variation portion that is less than 10 μm, which is 1/100 of the protrusion protrusion portion 3, the wall thickness variation portion is still present. , Upper thickness conversion portion F1 or lower thickness conversion portion F2.
As shown in FIGS. 4 (b) and 4 (c), the relational curve showing the upper thickness conversion portion F1 and the lower thickness conversion portion F is, for example, dividing the protruding protrusion H1 of the hollow protrusion 3 into 20 to 25 equal parts. It is preferable to plot the outer diameter r1, the inner diameter r2, and the wall thickness T1 at intervals.

In the present embodiment, the protrusion height H1 in the protrusion direction H is divided into two equal parts, and the vertical cross section of the hollow protrusion 3 is divided into a first region E1 where the apex P is located and a second region E2 where the base 2 is located. The upper thickness conversion portion F1 is located in the first region E1, and the lower thickness conversion portion F2 is located in the second region E2.
Further, the hollow projection portion 3 according to the present embodiment is on the base portion 2 side, that is, the second region E2, with respect to the position that bisects between the apex P and the other surface side 2U (upper surface side) of the base portion 2. In addition, a wall thickness portion F3 that gradually increases from the lower thickness conversion portion F2 is formed. The wall thickness portion F3 is thicker than the lower thickness conversion portion F2. The hollow protrusion 3 is formed so that the wall thickness is F2 <F1. The hollow protrusion 3 is formed so that the inner diameter r2 linearly increases from the first region E1 to the second region E2. The inner diameter r2 of the hollow protrusion 3 is not limited to the one that increases linearly, and may be in the form of increasing discontinuously. As a form in which the inner diameter r2 increases discontinuously, when the change of the inner diameter r2 is observed from the apex P side to the base portion 2 side, the inner diameter r2 is formed between the portion where the inner diameter r2 increases and the portion where the inner diameter r2 increases. There are cases where there is one or more fixed portions, cases where the inner diameter r2 is increased in multiple stages, and the like.

According to the fine hollow protrusion 1 of the present embodiment, the upper thickness conversion portion F1 is located on the apex P side of the base portion 2 of the hollow protrusion portion 3, and the lower thickness conversion portion F2 is located on the base portion 2 side of the apex P. Is located, it is possible to prevent the tip side where the apex P is located from being crushed when the hollow protrusion 3 is punctured into the object from the apex P side. Further, since the lower thickness conversion portion F2 is located on the base portion 2 side of the apex P, the resistance of the puncture operation is reduced and the puncture property is improved even when the skin is punctured.
Further, since the hollow protrusion 3 is provided with a wall thickness portion F3 that gradually increases from the lower thickness conversion portion F2 in the second region E2 located on the base portion 2 side, the base serving as the base of the hollow protrusion portion 3. The rigidity on the portion 2 side is improved, the blurring of the hollow protrusion portion at the time of puncturing is suppressed, the resistance of the puncturing operation is reduced, and the puncturing property is improved.

In the present embodiment, as shown in FIGS. 4A and 4B, the hollow protrusion 3 has an outer diameter in the vicinity of the apex P in the protrusion direction H from the apex P side to the base portion 2 side. r1 has an outer diameter rapid increase portion 32a in which the outer diameter rapidly increases, and the outer diameter r1 is located below the outer diameter rapid increase portion 32a in the vicinity of the central portion in the protruding direction H from the apex P side to the base portion 2 side. It has an outer diameter low change portion 32b that does not increase or the degree of increase is smaller than that of the outer diameter rapid increase portion 32a. Further, it has a lower outer diameter rapid increase portion 32c on the base portion 2 side of the outer diameter low change portion 32b in the protrusion direction H, in which the outer diameter r1 rapidly increases again from the apex P side to the base portion 2 side. ing. The boundary between the outer diameter rapid increase portion 32a and the outer diameter low change portion 32b preferably exists in the first region E1, and the boundary between the outer diameter low change portion 32b and the lower outer diameter rapid increase portion 32c is in the second region E2. It is preferable to exist. Further, as shown in FIG. 4B, the relational curve showing the relationship between the position of the protruding direction H and the outer diameter r1 is separated from the substantially linear relational line showing the relationship between the position of the protruding direction H and the inner diameter r2. It is preferable to have a curved portion convex in the direction in the first region E1, and a curved portion convex in a direction approaching a substantially linear relational line indicating the relationship between the position of the protruding direction H and the inner diameter r2 is provided in the second region. It is preferable to have it in E2.
In the present embodiment, the change in the wall thickness T1 from the apex P side toward the base portion 2 is controlled mainly by changing the outer diameter r1. To control the wall thickness T1 by giving a large change to the outer diameter r1 as compared with the inner diameter r2, for example, in the manufacturing method described later, the hollow protrusion 3 having the same shape is stably formed in the convex portion 11. It is preferable from the viewpoint of making it possible.

Further, in the fine hollow protrusion 1 according to the present embodiment, the lower thickness conversion portion F2 is the minimum thickness portion, while the lower thickness conversion portion F2 is on the apex P side and the lower thickness conversion portion F2 is on the apex P side. There is an upper thickness conversion portion F1 which is the maximum portion of the wall thickness in the above. As described above, according to the present invention, the hollow protrusion portion has the minimum wall thickness portion in the portion closer to the base portion 2 in the protrusion direction H, preferably the second region E2, and is more than the minimum wall thickness portion in the protrusion direction H. Also provided is a fine hollow protrusion having a hollow protrusion having a wall thickness larger than the minimum wall thickness on the apex P side, preferably the first region E1.

In the fine hollow protrusion 1 according to the present embodiment, as shown in FIG. 4C, in the vertical cross section, in the first region E1 with respect to the wall thickness of the lower thickness conversion portion F2 of the hollow protrusion 3 in the second region E2. The value of the ratio of the wall thickness of the upper thickness conversion portion F1 is set to 3.0 or more. The ratio of the wall thickness of the upper thickness conversion portion F1 in the first region E1 to the wall thickness of the lower thickness conversion portion F2 of the hollow protrusion portion 3 is hereinafter referred to as "the ratio of the upper thickness conversion portion F1: the lower thickness conversion portion F2". .. That is, the hollow protrusion 3 is formed so that the upper thickness conversion portion F1 has a wall thickness three times or more that of the lower thickness conversion portion F2.
The value of the ratio of the upper thickness conversion portion F1: the lower thickness conversion portion F2 is 3.0 or more, preferably 6 or more, more preferably 9 or more, 100 or less, preferably 50 or less, and more preferably 20 or less. Specifically, it is 3.0 or more and 100 or less, preferably 6 or more and 50 or less, and more preferably 9 or more and 20 or less.
According to the fine hollow protrusion 1 of the present embodiment, the ratio of the wall thickness of the upper thickness conversion portion F1 in the first region E1 to the wall thickness of the lower thickness conversion portion F2 in the second region E2 is 3.0 or more. If there is, as is clear from the test results described later, the puncture property is improved while suppressing the crushing of the tip side of the hollow protrusion 3.
Since the hollow protrusion 3 is made of a member containing a plastic resin, it can be easily formed by thermal processing.

Next, an example of a manufacturing apparatus for the fine hollow protrusion 1 formed as the microneedle array 1 (M) will be described.

FIG. 5 shows the overall configuration of the manufacturing apparatus 100 for the fine hollow protrusion 1. The manufacturing apparatus 100 includes a protrusion forming portion 10 for forming the hollow protrusion 3 on the base sheet 2A, a cooling portion 20, and a release portion 30 for extracting the convex portion 11. In the following description, the direction of transporting the base sheet 2A (longitudinal direction of the base sheet 2A) is the Y direction, the direction orthogonal to the transport direction and the width direction of the base sheet 2A to be transported are the X directions. The thickness direction of the base sheet 2A will be described as the T direction. 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 sheet 2A. In the present embodiment, the convex shape 110 has a structure arranged on a disk-shaped base portion 111. However, the present invention is not limited to this, and the convex portion 11 composed of only the convex 110 may be used, or the convex portion 11 in which a plurality of convex 110s are arranged on the trapezoidal support may be used.

The manufacturing apparatus 100 feeds the strip-shaped base sheet 2A from the raw fabric roll of the base sheet 2A formed by containing the thermoplastic resin and conveys it 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 embodiment, the strip-shaped base sheet 2A is intermittently transported. The transfer of the base sheet 2A is not limited to the transfer from the original roll, and for example, the substrate sheet 2A previously cut to a predetermined size may be intermittently supplied to a predetermined position by a robot or the like. good.

Examples of the thermoplastic resin include polyfatty acid esters, polycarbonates, polypropylenes, polyethylenes, polyesters, polyamides, polyamideimides, polyether ether ketones, 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 portion 2 of the fine hollow protrusion 1 to be manufactured.

The shape of the tip end side of the convex portion 11 may be a shape corresponding to the outer shape of the hollow protrusion 3 of the fine hollow protrusion 1 to be manufactured. As shown in FIG. 5, the convex 110 of the convex portion 11 is formed so that its height H2 is the same as or slightly higher than the protruding height H1 of the manufactured fine hollow protrusion 1 (hollow protrusion 3). It is preferably 0.01 mm or more, more preferably 0.02 mm or more, and preferably 30 mm or less, further preferably 20 mm or less, and specifically preferably 0.01 mm or more and 30 mm or less. Yes, more preferably 0.02 mm or more and 20 mm or less.
As shown in FIG. 6, the convex portion 110 of the convex portion 11 has a tip diameter D1 of preferably 0.001 mm or more, more preferably 0.005 mm or more, and preferably 1 mm or less, further preferably. 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 tip diameter of the convex shape 110 of the convex shape portion 11 is measured by using a scanning electron microscope (SEM) or a microscope in a state of being magnified by a predetermined magnification. 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 sides 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, the point where the one side side 11a is separated from the virtual straight line ILc is obtained as the first tip point 11a1, and the 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 thus obtained was measured using a scanning electron microscope (SEM) or a microscope, and the length of the straight line measured. Is the tip diameter of the convex type 110.

The convex shape 110 of the convex shape portion 11 has a root diameter D2 of preferably 0.1 mm or more, more preferably 0.2 mm or more, and preferably 5 mm or less, still more preferably 3 mm or less. Specifically, it is 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 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 degrees or less, from the viewpoint of obtaining the protrusion 3 having an appropriate angle. It is more preferably 5 degrees or more and 45 degrees or less. The tip angle α of the convex portion 11 is measured as follows.

The tip of the convex 110 of the convex portion 11 is observed using a scanning electron microscope (SEM) or a microscope in a state of being magnified at a predetermined magnification, for example, as shown in the SEM image shown in FIG. Next, the virtual straight line ILc is extended along the straight line portion on one side side 11a of the side sides 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) or a microscope, and the measured angle is measured as the tip angle α of the convex shape 110 of the convex shape portion 11. And.

As shown in FIG. 5, in the manufacturing apparatus 100, the first opening plate 12U and the second opening plate 13D are formed on the other surface side 2U (upper surface side) and the one surface side 2D (lower surface side) of the base sheet 2A. Each is arranged. These opening plates function as bending suppressing members. The manufacturing apparatus 100 is a protrusion forming step in a state where the base material sheet 2A is sandwiched between the support member 12 composed of the first opening plate 12U and the second support member 13 composed of the second opening plate 13D. Is supposed to do.
The support member 12 that supports the base sheet 2A serves to prevent the base sheet 2A from bending when the convex portion 11 is inserted from the one-side side 2D. Therefore, the support member 12 is arranged so as to support a region other than the region in which the convex portion 11 of the base sheet 2A is inserted, in other words, a region other than the region where the protrusion 3 is formed in the base sheet 2A. Has been done. As the support member 12 arranged in this way, the manufacturing apparatus 100 of the embodiment uses a first opening plate 12U having a plurality of openings 12a through which the convex 110 in the convex portion 11 can be inserted. The first opening plate 12U is formed of a plate-shaped member extending parallel to the transport direction (Y direction). In the first opening plate 12U, the base sheet 2A is supported in a region other than the opening 12a.

The first opening plate 12U may be formed with an opening area larger than the cross-sectional area of the convex 110 so that a plurality of convex 110s in the convex portion 11 can be inserted into one opening 12a. However, in the manufacturing apparatus 100 of the present embodiment, one convex shape 110 is formed so as to be inserted through one opening 12a.

The first opening plate 12U is movable in the T direction (thickness direction), which is a direction away from the direction of contact with the base sheet 2A. In the manufacturing apparatus 100 of the present embodiment, the first opening plate 12U can be moved in the T direction (thickness direction) by an electric actuator (not shown). The operation of the first opening plate 12U is controlled by the control means 300 provided in the manufacturing apparatus 100.

The manufacturing apparatus 100 includes means for applying energy to the convex portion 11. The means for applying energy to the convex portion 11 is a heating means, and is composed of, for example, an ultrasonic vibration device 200. The ultrasonic vibration device includes an ultrasonic oscillator and an ultrasonic horn that vibrates at a predetermined ultrasonic amplitude and oscillation frequency by an ultrasonic signal transmitted from the ultrasonic oscillator. The convex portion 11 has a base portion 111 mounted on the ultrasonic horn. The convex portion 11 vibrates integrally when the ultrasonic horn vibrates, and when it comes into contact with the base sheet 2A, the convex portion 11 applies ultrasonic vibration to the base sheet 2A to generate frictional heat.

In the present embodiment, after the protrusion forming step of forming the hollow protrusion 3, the cooling step of cooling the hollow protrusion 3 with the convex portion 11 pierced inside the hollow protrusion 3, and the cooling step, It is provided with a release step of removing the convex portion 11 from the inside of the hollow protrusion 3 to form the fine hollow protrusion 1.
As shown in FIG. 5, the manufacturing apparatus 100 feeds the strip-shaped base sheet 2A from the raw fabric roll of the base sheet 2A and conveys it in the Y direction. Then, after the strip-shaped base sheet 2A conveyed in the Y direction is stopped at a predetermined position, the convex portion 11 is brought into contact with the one-sided side 2D of the base sheet 2A, and the contact portion in the base sheet 2A is brought into contact with the convex portion 11. The convex portion 11 is softened by heat by vibrating the convex portion 11 and the convex portion 11 is pierced into the base sheet 2A to form a hollow protruding portion 3 protruding from the other surface side 2U of the base sheet 2A.

The control means 300 controls the stroke amount of the electric actuator and the ultrasonic amplitude of the ultrasonic vibration device 200. The stroke amount is the insertion height of the convex portion 11, and is the coordinate value Z in the present embodiment.
The control means 300 is hollow by changing the amount of heat applied to the base material sheet 2A per unit insertion height according to the coordinate value Z which is the insertion height of the convex portion 11 set in advance in the protrusion forming step. The shape of the protrusion 3 is controlled. Specifically, the amount of heat applied to the base sheet 2A is changed by adjusting the ultrasonic amplitude according to the coordinate value Z. That is, the shape of the hollow protrusion 3 [fine hollow protrusion 1] is controlled by changing the amount of heat by changing the ultrasonic amplitude during insertion into the base sheet 2A.
In this way, the control means 300 controls the ultrasonic vibration device 200, which is a means for applying energy to the convex portion 11 in the protrusion forming step, based on preset conditions, and the penetration height of the convex portion 11 is reached. The shape of the hollow protrusion 3 [fine hollow protrusion 1] is controlled by changing the amount of heat applied to the base sheet 2A accordingly. The control means 300 also has a function of controlling the shape of the hollow protrusion 3 [fine hollow protrusion 1] while keeping the ultrasonic amplitude constant without changing the ultrasonic amplitude during insertion into the base sheet 2A.

The control means 300 controls the shape of the hollow protrusion 3 with higher accuracy by constantly or non-linearly changing the heating conditions with respect to the coordinate value Z, which is the insertion height of the convex portion 11 set in advance. Is possible. In this embodiment, the ultrasonic amplitude with respect to the convex portion 11 by the ultrasonic vibration device 200 is used as a parameter of the heating condition. That is, the oscillation frequency is fixed and the ultrasonic amplitude is changed. As the parameter of the heating condition, the oscillation frequency may be used instead of the ultrasonic amplitude.

The relationship between the convex portion 11 and the ultrasonic amplitude will be described with reference to FIGS. 5 and 7 along with the manufacturing process.
FIG. 7 is a diagram illustrating the relationship between the manufacturing process of the fine hollow protrusion 1 and the timing and the amount of change in the amount of heat applied to the base sheet 2A. In FIG. 7, Za is a coordinate value transmitted from the electric actuator when the convex portion 11 occupies the lowest position away from the one-sided side 2D of the base material sheet 2A, and Z0 is the one-sided side of the base material sheet 2A. Indicates the 2D position. Zb indicates the coordinate value at which heating is started, and Zc indicates the coordinate value when the convex portion 11 occupies the maximum rising position.
In the present embodiment, after the strip-shaped base sheet 2A unwound from the original roll and conveyed in the Y direction is stopped at a predetermined position, the first opening plate 12U and the second opening plate 13D are moved up and down. The base sheet 2A is sandwiched between the first opening plate 12U and the second opening plate 13D, and the protrusion forming step is performed. At this stage, as shown in FIG. 7A, the convex portion 11 occupies a position separated from the one side 2D (lower surface side) of the base sheet 2A.
Then, when the electric actuator is driven by the control means 300 to move the convex portion 11 upward toward the base sheet 2A, heating control according to the coordinate value Z (insertion height) is executed. In the present embodiment, when the coordinate value Zb is reached, as shown in FIG. 7B, the ultrasonic vibration device 200 is operated to vibrate the convex portion 11. The ultrasonic amplitude at this time is A1.

In the present embodiment, the ultrasonic vibration device 200 raises the convex portion 11 toward the contact portion TP by the electric actuator in the ascending step shown in FIG. 7B from the standby state separated from the contact portion TP. The convex portion 11 is heated to generate heat in the contact portion TP to soften the contact portion TP. Then, as shown in FIG. 7 (c), the convex portion 11 is raised from the one side 2D (lower surface side) of the base sheet 2A toward the other side 2U (upper surface side) and pierced into the base sheet 2A. I will go.
When the convex portion 11 continues to rise while being stuck in the base sheet 2A, the ultrasonic amplitude is changed from A1 to A2 having a larger amplitude than A1 by the control means 300 as shown in FIG. 7 (d). The amount of heat given to the contact portion TP (base sheet 2A) increases, and the hollow protrusion 3 protruding from the other surface side 2U (upper surface side) of the base sheet 2A forms a predetermined shape.
In this way, when the coordinate value Z (insertion height) of the convex portion 11 fluctuates, the amplitude of the ultrasonic horn is changed accordingly to change the amount of heat applied to the base sheet 2A, thereby forming a protrusion. In the above, the shape of the fine hollow protrusion 1 per unit insertion height can be controlled with high accuracy according to the coordinate value Z of the convex portion 11 which is the insertion height of the convex portion 11 set in advance. Therefore, it is possible to form the fine hollow protrusion 1 having the hollow protrusion 3 having a desired shape without changing the shape of the convex portion 11.

The heating temperature of the base sheet 2A by the convex portion 11 is preferably equal to or higher than the glass transition temperature of the base material sheet 2A used and lower than the melting temperature from the viewpoint of efficiently forming the hollow protrusion 3, and is particularly softened. It is preferable that the temperature is equal to or higher than the melting temperature and lower than the melting temperature. In the case of the present embodiment, the heating temperature may be adjusted by adjusting the oscillation frequency and the ultrasonic amplitude so as to be within this temperature range.
In the present embodiment, when the coordinate value Z (insertion height) of the convex portion 11 fluctuates, the amplitude of the ultrasonic horn is switched so as to be larger than the amplitude before switching, but the desired hollow Depending on the shape of the protrusion 3, if the coordinate value Z (insertion height) of the convex portion 11 fluctuates, switching control may be performed so that the amplitude becomes smaller than the amplitude before switching. Further, even if the coordinate value Z (insertion height) of the convex portion 11 fluctuates, the ultrasonic amplitude given at the coordinate value Zb is not changed, and the convex portion 11 is vibrated while maintaining an arbitrary value. The hollow protrusion 3 may be formed. Further, the hollow protrusion 3 can change the shape of the convex portion 11 by changing the shape, the insertion speed, and the softening time of the convex portion 11 instead of changing the ultrasonic amplitude of the convex portion 11. ..

If the insertion speed at which the convex portion 11 is pierced into the base sheet 2A is too slow, the resin is excessively heated and softened, and if it is too fast, the heating and softening is insufficient. Therefore, it is preferably 0.1 mm / sec or more, more preferably 1 mm / sec or more, preferably 1000 mm / sec or less, still more preferably 800 mm / sec or less, and specifically preferably 0. .1 mm / sec or more and 1000 mm / sec or less, more preferably 1 mm / sec or more and 800 mm / sec or less. If the softening time, which is the time until the next step (cooling step) while the convex portion 11 is stopped in the heated state and the convex portion 11 is pierced inside the hollow protrusion 3, is excessively heated. However, from the viewpoint of compensating for insufficient heating, it is preferably larger than 0 seconds, more preferably 0.1 seconds or more, and preferably 10 seconds or less, still more preferably 5 seconds or less. It is preferably more than 0 seconds and 10 seconds or less, and more preferably 0.1 seconds or more and 5 seconds or less.

The height when the above-mentioned convex portion 11 is in the maximum rising position is defined as the maximum insertion height. The maximum insertion height does not refer to the height of the upper limit position mechanically limited by members such as the slider 203 and the electric actuator 204. The maximum insertion height is the state in which the convex portion 11 is inserted deepest in the protrusion forming step and the convex portion 11 comes out from the other surface side 2U of the base sheet 2A (FIG. 9 (d)). It is the distance from the one side 2D of the base material sheet 2A to the apex of the convex portion 11 measured in the vertical direction. For example, in the case of manufacturing a hollow protrusion 3 having a protrusion height H1 = 1 mm, when the thickness T2 of the base sheet 2A is 0.4 mm, the maximum insertion height is 1.4 mm, and the hollow height is 0.6 mm. In the case of manufacturing the protrusion 3, if the thickness T2 of the base sheet 2A is 0.4 mm, the maximum insertion height is 1.0 mm.

In the manufacturing apparatus 100 described in the present embodiment, as shown in FIG. 5, a plurality of hollows are formed in the cooling unit 20 with the base sheet 2A sandwiched between the first opening plate 12U and the second opening plate 13D. The protrusion 3 is cooled. In this embodiment, FIG. 7E shows a cooling step, and the ultrasonic amplitude is set to 0 in this state. The timing at which the ultrasonic amplitude is set to 0 is controlled by the control means 300 after the convex portion 11 occupies the maximum rising position Zc and a predetermined time elapses, and the heating control for the base sheet 2A is stopped. In the cooling step, the hollow protrusion 3 is cooled with the convex portion 11 pierced inside.

Since the heating means described in the present embodiment is the ultrasonic vibration device 200, it cools quickly when the vibration disappears, and it is not always necessary to provide the cooling unit 20 with the cooling device. It is preferable to use the ultrasonic vibration device 200 as a heating means as described above because the device is simplified and the fine hollow protrusion 1 can be easily manufactured at high speed. Further, heat is less likely to be transferred to the portion of the base sheet 2A that is not in contact with the convex portion 11, and cooling is efficiently performed by turning off the ultrasonic vibration application, so that deformation other than the molded portion occurs. It has the advantage of being difficult.
Of course, cooling by the cooling device is not denied in the cooling process, and if it is desired to cool the cooling device earlier, a known cooling device such as a blower fan is installed in the cooling section 20 to cool the plurality of hollow protrusions 3. You may.

Next, in the manufacturing apparatus 100, as shown in FIG. 5, the release step is performed in the release unit 30. In the release step, as shown in FIG. 7 (f), the electric actuator is driven to lower the convex portion 11 in the direction away from the one surface side 2D (lower surface side) of the base sheet 2A, and the hollow protrusion is formed. The convex portion 11 is pulled out from the state where the convex portion 11 is pierced inside the portion 3, and a plurality of fine hollow protrusions 3 form a precursor 1B protruding from the base portion 2. Then, by cutting the precursor 1B to a predetermined length, the fine hollow protrusion 1 is manufactured.

By the way, conventionally, a hollow protrusion 3 is formed by using a convex portion 11, and finally a fine hollow protrusion 1 is manufactured. If the convex portion 11 can be formed into a desired shape, it is possible to obtain a hollow protrusion 3 or a fine hollow protrusion 1 having a desired shape, but the convex portion 11 can be processed into a complicated shape. Is difficult and cannot be formed depending on the shape. Further, even if it can be processed, when forming the fine hollow protrusion 1, the convex portion 11 must be replaced for each shape of the fine hollow protrusion 1 to be formed.

When the convex portion 11 is penetrated through the base sheet 2A while heating at a temperature higher than the softening temperature of the base sheet 2A to form the fine hollow protrusion 1, the protruding height of the fine hollow protrusion 1 to be formed is formed. Depending on H1, it is difficult to adjust the amount of heat per unit height given to the base sheet 2A. For example, when the protrusion height H1 is about 1 mm, if the amount of heat is large, heat is transferred quickly and the shape of the protrusion collapses. Further, if the amount of heat is too low, the base sheet 2A cannot be sufficiently softened, and the hollow protrusions 3 cannot be sufficiently formed. As a result, it becomes difficult to form the fine hollow protrusion 1 having a desired shape. That is, when the shape of the fine hollow protrusion 1 (hollow protrusion 3) is to be changed without changing the shape of the convex portion 11, the shape is given according to the insertion height [coordinate value Z] of the convex portion 11. It is necessary to control the amount of heat. However, it is difficult to form the fine hollow protrusion 1 having a desired shape by controlling the amount of heat unless the sensitivity to heat of the convex portion 11 [temperature change characteristic], the material of the base sheet 2A, and the like are controlled. be. Further, when the calorific value is not controlled and the shape is changed by changing the insertion speed of the convex portion 11 independently, the change in the insertion speed changes depending on the protrusion height H1 of the fine hollow protrusion 1. It may not affect the formation of.

Therefore, the ultrasonic vibration device 200 that applies energy to the convex portion 11 is controlled based on preset conditions, and is added to the base sheet 2A according to the insertion height (coordinate value Z) of the convex portion 11. By changing the amount of heat, the shape of the fine hollow protrusion 1 can be controlled with high accuracy, which is preferable.
When the ultrasonic vibration device 200 is used as a means for applying energy to the convex portion 11, the responsiveness to the change in heat quantity is good, and the fine hollow protrusion 1 having a more desired shape can be formed.

When the change in the amount of heat applied to the base material sheet 2A in the protrusion forming step uses the ultrasonic amplitude with respect to the insertion height (coordinate value Z) of the convex portion 11 by the ultrasonic vibration device 200 as a parameter of the heating condition, the temperature change. It is preferable because it has good responsiveness to light and can control the shape of the fine hollow protrusion 1 (hollow protrusion 3) with higher accuracy. When the amount of heat applied to the base sheet 2A is continuously changed, it is possible to process by continuously changing the temperature when manufacturing the fine hollow protrusion 1, and the shape of the fine hollow protrusion 1 can be controlled with higher accuracy. It is preferable because it can be used.
When the convex portion 11 moves toward the base sheet 2A, instead of using the ultrasonic amplitude with respect to the insertion height (coordinate value Z) of the convex portion 11 by the ultrasonic vibrating device 200 as a parameter of the heating condition. The insertion speed of may be used as a parameter.

From the viewpoint of suppressing the thinning of the protrusion tip due to excessive softening of the base material sheet 2A immediately after the contact and controlling the shape of the fine hollow protrusion 1 with higher accuracy, the convex portion 11 and the convex portion 11 are used in the protrusion forming step. It is preferable to set the amount of heat immediately after contact with the base sheet 2A to be smaller than the amount of heat immediately after forming the protrusions.
In the present embodiment, immediately after the contact, the convex portion 11 occupies the position of Z0 in FIG. 7, and immediately after the protrusion is formed, the convex portion 11 occupies the position of Zc in FIG. 7. Is.

FIG. 8 is a vertical cut end view of a plurality of hollow protrusions 3 formed by using the manufacturing apparatus 100 with different ultrasonic amplitudes. 8 (a) is a hollow protrusion 330 formed with an ultrasonic amplitude of 30%, FIG. 8 (b) is a hollow protrusion 345 formed with an ultrasonic amplitude of 45%, and FIG. 8 (c) is a hollow protrusion with an ultrasonic amplitude of 70%. The formed hollow protrusion 370, FIG. 8 (d) shows the hollow protrusion 390 formed with an ultrasonic amplitude of 90%, and FIG. 8 (e) shows the hollow protrusion 3 formed by switching the ultrasonic amplitude from 30% to 90%. show. The hollow protrusion 3 shown in FIG. 8 (e) is a hollow protrusion according to the present embodiment. For each hollow protrusion shown in FIG. 8, the thickness of the base sheet 2A, the shape of the convex portion, the insertion speed, the insertion height, the oscillation frequency, and the softening time, which are conditions other than the ultrasonic amplitude, are all the same. There is. The hollow protrusion 3 shown in FIG. 8 (e) can be obtained by switching the ultrasonic amplitude between A1 and A2 at the timing shown in FIG. 7.

9 (a) to 9 (c) are views in which the measured values of the inner diameter, the outer diameter, and the wall thickness of the hollow protrusion shown in FIG. 8 are plotted. 9 (a) shows the change in the outer diameter of each hollow protrusion, FIG. 9 (b) shows the change in the inner diameter of each hollow protrusion, and FIG. 9 (c) shows the change in the wall thickness of each hollow protrusion. Is shown. In FIGS. 9A to 9C, the vertical axis indicates the value of the distance from the apex P toward the other surface side 2U of the base portion 2 (distance along the protrusion direction H), and the horizontal axis indicates the width direction X1. Shows the dimensions of.
The value of the ratio of the upper thickness conversion portion F1: the lower thickness conversion portion F2 of the hollow protrusion 330 formed with the ultrasonic amplitude of 30% was 1.82.
The value of the ratio of the upper thickness conversion portion F1: lower thickness conversion portion F2 of the hollow protrusion portion 345 formed with the ultrasonic amplitude of 45% was 2.44.
The value of the ratio of the upper thickness conversion portion F1: lower thickness conversion portion F2 of the hollow protrusion portion 370 formed with the ultrasonic amplitude of 70% was 1.78.
The value of the ratio of the upper thickness conversion portion F1: lower thickness conversion portion F2 of the hollow protrusion portion 390 formed with the ultrasonic amplitude of 90% was 2.27.
The value of the ratio of the upper thickness conversion portion F1: lower thickness conversion portion F2 of the hollow protrusion portion 3 in the present embodiment was 9.78.

Among the plurality of hollow protrusions shown in FIG. 8, the hollow protrusion 330 manufactured with an ultrasonic amplitude of 30%, the hollow protrusion 390 manufactured with an ultrasonic amplitude of 90%, and the hollow protrusion 3 according to the present embodiment are used. Then, a puncture load evaluation test was performed.
In the puncture load evaluation test, hollow protrusions 3, 330, 390 with a protrusion height of 1000 μm (1 mm) are set in a well-known load cell, which is a strain measuring device, respectively, and perpendicular to the skin model for test. The load change when the hollow protrusions 3, 330, 390 are punctured is measured. The evaluation result at this time is shown in FIG.
In FIG. 10, the vertical axis indicates the load [N] at the time of puncture, and the horizontal axis indicates the puncture depth [mm]. Each hollow protrusion exhibits almost the same load displacement up to a puncture depth of about 0.6 mm. Up to a puncture depth of 0.6 mm, the load gradually increases as the puncture depth increases. This is because each hollow protrusion presses against the skin model.
In the case of the hollow protrusion 3 according to the present embodiment, the load drops at once when the puncture depth exceeds 0.6 mm. This is because the hollow protrusion 3 penetrates the surface of the skin model. In addition, after the load drops at once, the load change remains flat up to about 0.8 mm. It is presumed that this is because the puncture depth is increased but the load increase is small, the tip crushing is suppressed, and the resistance at the time of puncture is lowered. When the load leveling off is over, the load increases at once. It is presumed that this is because the resistance increased as the puncture became deeper.

From the result of the load displacement by the hollow protrusion 3, the hollow protrusion 3 has the upper thickness conversion portion F1 located on the tip side where the apex P is located and is durable as the wall thickness on the tip side of the hollow protrusion 3 increases. The properties are high, and the wall thickness gradually decreases from the upper thickness conversion portion F1 to the lower thickness conversion portion F2, but the change in the outer diameter r1 is small, and the resistance is low due to the linear state. That is, due to the thickening of the tip of the hollow protrusion 3 and the appearance shape after that, the puncture load required for penetration of the skin surface is reduced and the load after penetration is constant, so that the tip collapse is suppressed and the puncture is easy. It can be inferred that the puncture property has improved.

On the other hand, in the case of the hollow protrusion 390 having an ultrasonic amplitude of 90%, the load increases up to a puncture depth of about 0.8 mm, then the load decreases once, and then the load increases at once. This is because the hollow protrusion 390 crushes the tip side of the hollow protrusion 390 to become resistance up to about 0.8 mm and cannot penetrate the surface of the skin model, and penetrates the surface of the skin model when it exceeds 0.8 mm. Is.
Further, the load change of the hollow protrusion 330 having an ultrasonic amplitude of 30% is the same as that of the hollow protrusion 3 of the present embodiment, but the flat period of the load change after the load drops at once is the hollow protrusion. It is shorter than 3. It is presumed that this is because the change in the outer diameter r1 of the hollow protrusion 330 is large and the resistance at the time of puncturing is larger than that of the hollow protrusion 3.

11 (a) is a perspective view showing a fine hollow protrusion 1A provided with a hollow protrusion 3A having a through hole 3h, and FIG. 11 (b) is a cross-sectional end view taken along the line BB of FIG. 11 (a). Is. FIG. 12 shows a form of a manufacturing apparatus for manufacturing the fine hollow protrusion 1A.
The fine hollow protrusion 1A includes a hollow protrusion 3A in which a through hole 3h is formed in the hollow protrusion 3 of the fine hollow protrusion 1 described above. The fine hollow protrusion 1A has a through hole 3h on the outer surface 32 thereof that communicates with the internal space 3s in the hollow protrusion 3A. The through hole 3h is arranged in a thick region of the hollow protrusion 3A. The thick region in which the through hole 3h is arranged is the first region E1 described above. The inner diameter r2 of the fine hollow protrusion 1A increases linearly from the first region E1 to the second region E2 of the hollow protrusion portion.

In the manufacturing apparatus 100A shown in FIG. 12, the manufacturing apparatus 100 described with reference to FIG. 5 is provided with a hole forming portion 40. The opening forming portion 40 is provided with a non-contact type opening means 4 on the other surface side 2U (upper surface side) of the base sheet 2A. Examples of the non-contact type opening means 4 include a processing device using a heat source, such as a laser light irradiating device that irradiates laser light, a hot air emitting device that emits hot air, and a halogen lamp irradiating device that irradiates infrared rays. .. In the manufacturing apparatus 100A, a laser light irradiation apparatus is used as the non-contact type opening means 4 from the viewpoint of condensing property required for microfabrication and high-precision energy control.

As shown in FIG. 12, the laser light irradiation device (non-contact type opening means 4) includes an irradiation head 41 which is a galvano scanner that freely scans the laser light 4L. The irradiation head 41 is arranged on the other surface side 2U (upper surface side) of the base sheet 2A at a certain interval above the other surface side 2U in the T direction (thickness direction).
When the laser beam 4L is irradiated to the non-penetrating hollow protrusion 3A from the irradiation head 41 arranged on the other surface side 2U of the base sheet 2A in this way, the hollow protrusion 3A has the outer surface 32 and the inner surface of the hollow protrusion 3A. A through hole 3h that penetrates up to 31 can be formed. Further, since the through hole 3h is easily formed at an arbitrary position of the hollow protrusion 3A, it is easy to arbitrarily control the position with respect to the skin surface to which the solution or the like is to be supplied.

As shown in FIG. 12, the irradiation head 41 includes a lens 43 that collects the irradiated laser light 4L, two mirrors 42 that freely scan the focused laser light 4L, and a protective lens 44. The protective lens 44 may not be provided, but it is preferable to provide it from the viewpoint of preventing dust and dirt from entering the optical system. The mirror 42 is attached to a motor shaft (not shown). The mirror 42 includes a mechanism for moving the irradiation point where the laser beam 4L hits the hollow protrusion 3 on the base sheet 2A in the Y direction and a mechanism for moving the laser beam in the X direction so that the laser beam 4L can be freely scanned. It has become. The lens 43 is movable in the optical axis direction, and is a mechanism for condensing 4 L of laser light to make the spot diameter of the irradiation point of the laser light 4L hitting the hollow protrusion 3 constant, irradiation of the laser light 4L. It is provided with a mechanism for moving points in the T direction (thickness direction) of the base sheet 2A. The irradiation head 41 having the mirror 42 and the lens 43 can adjust the irradiation point of the laser beam 4L in three dimensions including the X direction, the Y direction, and the T direction. Therefore, by coordinating the positions to be irradiated of each of the plurality of hollow protrusions 3 (9 in the illustrated form) in three dimensions, the laser beam 4L is applied to the positions to be irradiated by each of the hollow protrusions 3 with a predetermined spot diameter. Can be irradiated with. As the laser beam 4L, it is preferable to use one that can be absorbed by the hollow protrusion 3 forming the through hole 3h. When the base material sheet 2A forming the hollow protrusion 3 is a sheet such as a film mainly composed of a thermoplastic resin, the laser light 4L includes a CO ₂ laser, an excima laser, an argon laser, a YAG laser, and an LD laser ( It is preferable to use a semiconductor laser), a _YVO4 laser, a fiber laser, or the like.

As described above, when the through hole 3h is formed in the opening step which is the secondary processing, it is preferable to control the shape of the fine hollow projection 1 according to the opening position where the through hole 3h is formed.

According to the present embodiment, since the through hole 3h penetrating from the outer surface 32 to the inner surface 31 is formed in the hollow protrusion 3A, when the solution is sealed in the internal space of the hollow protrusion 3A and the skin is punctured. The solution can be discharged from the through hole 3h.
Since the through hole 3h is arranged in a thick region of the hollow protrusion 3A, specifically, the first region E1, even if the through hole 3h is formed, the rigidity of the hollow protrusion 3A on the tip end side is maintained. It can be secured, and the puncture property can be improved by suppressing the crushing of the hollow protrusion 3A.
Since the inner diameter r2 of the hollow protrusion 3A increases linearly from the first region E1 to the second region E2 of the hollow protrusion 3A, the liquid flow path through which the solution flows despite the tip wall thickness. Since the cross-sectional area of the internal space becomes smaller toward the tip, the flow velocity increases and the solution becomes easier to discharge.

FIG. 13 shows a plurality of hollow protrusions having through holes 3h formed by the manufacturing apparatus 100A. Here, in addition to the hollow protrusion 3A according to the present embodiment, the hollow protrusion 3B is formed. The protruding height of each hollow protrusion was 1000 μm.
The hollow protrusion 3A is formed to have a thick tip by switching the ultrasonic amplitude from 30% to 90%. The hollow protrusion 3B described in the column of the conventional method is formed with an ultrasonic amplitude of 45%.

A puncture evaluation experiment was performed using these two hollow protrusions.
In the experiment, the auricle skin of the pig was attached to the inner part of the human forearm, which is the base, without any gap, and integrated to prepare the target for puncture. A load of 500 g was applied to the two hollow protrusions shown in FIG. The auricle was punctured. The puncture success rate and the protrusion height reduction rate [%] at this time were set as evaluation items, and the evaluation results are summarized in FIG.

The puncture success rate was determined from the number of successful punctures with respect to the number of times the hollow protrusions 3A and 3B were punctured with respect to the skin model. It was judged that the state in which the solution injected after the puncture remained on the skin was successful, and the success rate was judged to be higher as the number of times the solution remained. In this embodiment, the puncture success rate is indicated by 〇, ×, and Δ. 〇 indicates a success rate of 90% or more, × indicates a success rate of 10% or less, and Δ indicates other than that.
The protrusion height reduction rate [%] is the difference between the protrusion height before puncture (1000 μm) and the protrusion height after puncture measured by extracting from the subcutaneous model after puncture, divided by the protrusion height before puncture. It was calculated from the average value of the values. Of these two evaluation items, the puncture success rate was used as a judgment material for punctureability, which is the ease of puncture, and the protrusion height reduction rate [%] was used as a judgment material for crush resistance.

〔evaluation〕
Looking at the puncture success rate, in the case of the hollow protrusion 3A according to the present embodiment, the solution is injected into the skin with a high probability with respect to the puncture success rate (Δ) of the hollow protrusion 3B, and the puncture success rate is high. It was a rate.
Looking at the protrusion height reduction rate [%], the hollow protrusion 3B was 3.3 [%], and the hollow protrusion 3A was 0.3%. It is presumed that in the case of the hollow protrusion 3A, the wall thickness on the tip side is thick, the tip is less likely to be crushed, and the protrusion height reduction rate [%] is low. On the other hand, in the case of the hollow protrusion 3B, it is presumed that the tip crushing is larger than that of the hollow protrusion 3A and the protrusion height reduction rate [%] is higher.

FIG. 14 is a diagram showing the relationship between the wall thickness of the hollow protrusion, the distance from the apex P, and the tip collapse. In FIG. 14, the vertical axis indicates the wall thickness [μm], and the horizontal axis indicates the distance from the apex P of the hollow protrusion 3 in the protrusion direction H toward the other surface side 2U of the base 2. In FIG. 14, the region J surrounded by the dotted line generally indicates a region where the tip of the hollow protrusion is crushed. Technically, by forming the thickness of this region to be thick, the tip is less likely to be crushed. Since the hollow protrusion 3A according to the present embodiment is formed to have a thick tip side, it is formed to be thicker than the conventional hollow protrusion 3B in the region J where crushing occurs. From this, it can be said that the shape of the hollow protrusion 3A is such that the tip is not easily crushed. When the tip is less likely to be crushed in this way, especially when the through hole 3h is formed, the opening area of the through hole 3h is less likely to be narrowed by the crushing, which leads to reliable discharge of the solution in the internal space.

The solution according to the embodiment is an agent to be injected into the skin. The agent is not particularly limited as long as it can be injected into the skin using the microhollow protrusion of the present invention, for example, a liquid agent containing an active ingredient for improving the condition of the skin, a vaccine used for prevention of infectious diseases. Drugs including.
The skin to be punctured by the fine hollow protrusion is typically human skin, but may be skin of pets such as dogs and cats, and skin of domestic animals such as cows, pigs, and goats. Further, the skin of animals other than mammals, for example, the skin of snakes, frogs, silk moths and the like may be used.

Regarding the above-described embodiment, the present invention further discloses the following fine hollow protrusions.
<1>
A fine hollow protrusion having an internal space protruding from the base, and a fine hollow protrusion that is punctured by an object from the apex side of the hollow protrusion.
In the hollow protrusion, the distance between the outer surfaces located in the width direction orthogonal to the protrusion direction of the hollow protrusion is set in the outer diameter and the width direction when the vertical cross section passing through the apex of the hollow protrusion is viewed. When the distance between the inner surfaces located is defined as the inner diameter, and the value of half the difference between the outer diameter and the inner diameter in the region where the inner diameter is larger than 0 is defined as the wall thickness.
The inner diameter increases continuously or discontinuously from the apex side toward the base portion.
From the apex side to the base portion side, the lower thickness conversion portion has an upper thickness conversion portion in which the wall thickness changes from an increase to a decrease, and a lower thickness conversion portion in which the wall thickness changes from a decrease to an increase. However, the fine hollow projection tool is located on the base portion side of the upper thickness conversion portion.

<2>
In the hollow protrusion, the upper thickness conversion portion is located on the tip side where the apex is located, the wall thickness on the tip side of the hollow protrusion is increased, and the thickness is increased from the upper thickness conversion portion to the lower thickness conversion portion. The fine hollow protrusion according to the above <1>, wherein the wall thickness gradually decreases, the change in the outer diameter is small, and the surface is in a linear state.
<3>
The value of the ratio of the wall thickness of the upper thickness conversion portion to the wall thickness of the lower thickness conversion portion is 3.0 or more, preferably 6 or more, more preferably 9 or more, 100 or less, preferably 50 or less, and more. The fine hollow projection tool according to <1> above, preferably 20 or less, specifically 3.0 or more and 100 or less, preferably 6 or more and 50 or less, and more preferably 9 or more and 20 or less.
<4>
When the protrusion height of the hollow protrusion is divided into two equal parts in the protrusion direction and the vertical cross section is divided into a first region where the apex is located and a second region where the base is located, the first region is divided. The fine hollow projection tool according to <1>, wherein the upper thickness conversion portion is located in one region and the lower thickness conversion portion is located in a second region.
<5>
The fineness according to <3>, wherein in the vertical cross section, the value of the ratio of the wall thickness of the upper thickness conversion portion in the first region to the wall thickness of the lower thickness conversion portion in the second region is 3.0 or more. Hollow protrusion.

<6>
The fine hollow protrusion according to any one of <1> to <5>, wherein the hollow protrusion is made of a member containing a thermoplastic resin.
<7>
The fine hollow protrusion tool according to any one of <1> to <6>, wherein the hollow protrusion is formed by projecting one or a plurality of the hollow protrusions from the base.
<8>
The fine hollow projection tool according to any one of <1> to <7>, which has a through hole communicating with the internal space on the tip side or the outer surface where the apex is located.
<9>
The fine hollow protrusion tool according to <8>, wherein the through hole is arranged in a thick region of the hollow protrusion portion.
<10>
The fine hollow projection tool according to <9>, wherein the thick region in which the through hole is arranged is a first region.
<11>
The fine hollow protrusion tool according to any one of <4> to <10>, wherein the inner diameter increases linearly from the first region to the second region of the hollow protrusion portion.

1,1A Fine hollow protrusion 2 Base part 3,3A Fine hollow protrusion 3h Through hole 3s Space 31 Inner surface 32 Outer surface E1 First area E2 Second area F1 Upper thickness conversion part F2 Lower thickness conversion part H Protrusion direction H1 Height P Top of hollow protrusion r1 Outer diameter r2 Inner diameter T1 Wall thickness X1 Width direction

Claims (9)

A fine hollow protrusion having an internal space protruding from the base, and a fine hollow protrusion that is punctured by an object from the apex side of the hollow protrusion.
In the hollow protrusion, the distance between the outer surfaces located in the width direction orthogonal to the protrusion direction of the hollow protrusion is set in the outer diameter and the width direction when the vertical cross section passing through the apex of the hollow protrusion is viewed. When the distance between the inner surfaces located is defined as the inner diameter, and the value of half the difference between the outer diameter and the inner diameter in the region where the inner diameter is larger than 0 is defined as the wall thickness.
The inner diameter increases continuously or discontinuously from the apex side toward the base portion.
From the apex side to the base portion side, the lower thickness conversion portion has an upper thickness conversion portion in which the wall thickness changes from an increase to a decrease, and a lower thickness conversion portion in which the wall thickness changes from a decrease to an increase. However, the fine hollow projection tool is located on the base portion side of the upper thickness conversion portion. When the protruding height of the hollow protrusion is divided into two equal parts and the vertical cross section is divided into a first region where the apex is located and a second region where the base is located, the upper portion is divided into the first region. The fine hollow projection tool according to claim 1, wherein the thickness conversion portion is located and the lower thickness conversion portion is located in the second region. The fine hollow according to claim 2, wherein in the vertical cross section, the value of the ratio of the wall thickness of the upper thickness conversion portion in the first region to the wall thickness of the lower thickness conversion portion in the second region is 3.0 or more. Protrusion tool. The fine hollow protrusion tool according to any one of claims 1 to 3, wherein the hollow protrusion portion is made of a member containing a thermoplastic resin. The fine hollow protrusion tool according to any one of claims 1 to 4, wherein the hollow protrusion portion is formed by projecting one or a plurality of the hollow protrusion portions from the base portion. The fine hollow projection tool according to any one of claims 1 to 5, which has a through hole communicating with the internal space on the tip side or the outer surface where the apex is located. The fine hollow protrusion tool according to claim 6, wherein the through hole is arranged in a thick region of the hollow protrusion portion. The fine hollow projection tool according to claim 7, wherein the thick region in which the through hole is arranged is a first region. The fine hollow protrusion tool according to any one of claims 2 to 8, wherein the inner diameter increases linearly from the first region to the second region of the hollow protrusion portion.

Images