JP7522006B2 - Manufacturing method of hollow protruding tool - Google Patents

Description

The present invention relates to a method for manufacturing a hollow protrusion tool.

Micro hollow protrusion devices (microneedles) that can supply medicine painlessly by puncturing a shallow layer of the skin with a micro-sized needle are used in the medical and cosmetic fields. In this technical field, Patent Document 1 discloses a technique in which a protrusion forming part is inserted from one side of a base sheet to form a non-penetrating hollow protrusion, and a laser beam is irradiated from the other side of the base sheet to form an opening (paragraphs [0044] to [0060] of the same document, FIG. 6, claim 1, etc.). Patent Document 2 discloses a hollow plastic injection needle in which a drug solution outlet hole is machined by laser processing on the slope or side of the tip of the injection needle (paragraphs [0006] to [0016] of the same document, FIG. 1, etc.). Furthermore, Patent Document 3 discloses a technique in which a sheet member is formed on one main surface of a carrier film, and the carrier film and the sheet member are irradiated with an ultraviolet laser to form through holes in the carrier film and the sheet member (paragraphs [0046] to [0047], Figure 1, etc. of the same document).

JP 2019-50927 A JP 2002-172169 A International Publication No. 2018/194066

However, in the technology described in Patent Document 1, when the hollow protrusion formed by inserting the protrusion forming part into the base sheet is cooled with the protrusion forming part inserted inside the hollow protrusion, the protrusion forming part is removed, and then a through hole is formed using a non-contact thermal processing means (e.g., a laser light irradiation device), the shape of the hollow protrusion tool may be bent or curved due to the influence of the melting heat when the through hole is formed. In addition, in the technology described in Patent Document 2, a hollow structure injection needle is formed using a mold, so it is not possible to manufacture a hollow protrusion tool that is inexpensive, has good productivity, and is easy to mold. In the technology described in Patent Document 3, a through hole is formed by irradiating an ultraviolet laser onto a two-layer sheet, so it is not possible to manufacture a hollow protrusion tool. Therefore, the object of the present invention is to provide a method for manufacturing a hollow protrusion tool with good moldability.

The present invention relates to a method for manufacturing a hollow protruding tool having a hollow protruding portion having an opening,
A sheet arrangement step of arranging a base sheet containing a thermoplastic resin so as to face a shaping mold having a complementary shape to the hollow protrusion tool;
a projection forming step of contacting a convex portion having a heating portion with the base sheet from a surface side of the base sheet that does not face the shaping mold, and inserting the convex portion into the base sheet toward the shaping mold while softening the contact portion of the base sheet with the heat;
a release step of pulling the convex portion out of the base sheet to form the hollow protrusion portion;
An opening forming step of forming the opening penetrating the shaping mold and the hollow protrusion portion;
The present invention relates to a method for producing a hollow protruding tool comprising the steps of:

The present invention makes it possible to manufacture hollow protruding tools with good moldability.

FIG. 1 is a perspective view showing an example of a hollow protrusion device (microneedle array) produced by the production method of the present invention. 2(a) is a perspective view of one hollow protrusion shown in FIG. 1, and FIG. 2(b) is a cross-sectional view taken along line II-II shown in FIG. 2(a). FIG. 3 is an explanatory diagram showing a method for measuring the tip diameter of a hollow protrusion. FIG. 4 is a diagram for explaining an outline of the manufacturing method of the present invention. FIG. 5 is a diagram showing one embodiment of a manufacturing apparatus used in the manufacturing method of the present invention, and is a perspective view showing an outline of the manufacturing apparatus for manufacturing the hollow protrusion portion shown in FIG. 6(a) and (b) are cross-sectional views for explaining the protrusion forming step according to the present invention. FIG. 7 is a perspective view that shows a schematic view of the convex mold and the shaping protrusion portion shown in FIG. 5(b). FIG. 8 is an explanatory diagram showing a method for measuring the tip angle of a convex die according to the present invention. FIG. 9 is a diagram for explaining an outline of the manufacturing method according to the second embodiment. FIG. 10 is a perspective view for explaining one embodiment of the shaped sheet projection forming step. FIG. 11 is a perspective view for explaining another example of the shaped sheet projection forming step.

The present invention will now be described based on preferred embodiments with reference to the drawings. First, one embodiment of a hollow protrusion tool obtained by the manufacturing method of the present invention will be described with reference to Figs. 1 to 8.

[First embodiment]
FIG. 1 shows a microneedle array 1 (hollow protrusion tool), which is one embodiment of a hollow protrusion tool having fine hollow protrusions. The microneedle array 1 of this embodiment has a sheet-like base 2 and a plurality of hollow protrusions 3, and an opening 8 is provided on the tip side of the hollow protrusions 3. The hollow protrusions 3 protrude from the base 2, and the inside is hollow. The microneedle array 1 opens on the opposite side of the part of the base 2 where the hollow protrusions 3 are formed, and an opening 7 is formed. The opening 7 and the internal space V of the hollow protrusions 3 are connected. The internal space V of the hollow protrusions 3 is formed in a cone shape corresponding to the outer shape of the hollow protrusions 3. That is, the inner peripheral surface 4 of the hollow protrusions 3 has a shape corresponding to the outer peripheral surface of the hollow protrusions 3. The shape of the hollow protrusions 3 can be any shape such as a cone shape, a truncated cone shape, a cylinder shape, a prism shape, a pyramid shape, or a truncated pyramid shape.

The microneedle array 1 has a plurality of truncated cone-shaped hollow protrusions 3 in an array (matrix) on the upper surface of the base 2. Specifically, nine hollow protrusions 3 are arranged in an array, with three rows in a direction X along the direction X1 (longitudinal direction of the base sheet 20) in which the substrate sheet 20 described below is transported, and three columns in a direction Y perpendicular to the direction X. The direction Y is a direction perpendicular to the direction X1 in which the substrate sheet 20 is transported (width direction of the substrate sheet 20). The number and arrangement of the hollow protrusions 3 are not particularly limited, and may be any number and arrangement.

When the microneedle array 1 is applied to the skin, it is preferable that the tip of the hollow protrusion 3 can be inserted as far as the stratum corneum at the shallowest point and as far as the dermis at the deepest point. From this viewpoint, the protrusion height H1 of the hollow protrusion 3 (see FIG. 2(b)) is preferably 0.01 mm or more, more preferably 0.02 mm or more, and also preferably 10 mm or less, more preferably 5 mm or less, and also preferably 0.01 mm or more and 10 mm or less, more preferably 0.02 mm or more and 5 mm or less. The protrusion height H1 is the distance between the upper surface 2U of the base 2 from which the hollow protrusion 3 protrudes, a virtual line P1 that is parallel to the upper surface 2U of the base 2 and passes through the apex P of the hollow protrusion 3. When the upper surface 2U is not a flat surface but has wavy unevenness, the height direction Z of the hollow protrusion 3 is aligned vertically, and the virtual line P1 is a line that passes through the apex P and is parallel to the horizontal direction. The distance between the imaginary line P1 and the top of the convex portion of the unevenness on the upper surface 2U side is defined as the protrusion height H1. The distance between the imaginary line P1 and the upper surface 2U (protrusion height H1) is measured by magnifying and observing the hollow protrusion portion 3 using a scanning electron microscope (SEM) or a microscope.

The thickness T1 of the hollow protrusion 3 (see FIG. 2(b)) may be constant along the height direction Z of the hollow protrusion 3, or may vary. For example, the thickness T1 of the hollow protrusion 3 may gradually decrease from the base 2 side toward the tip side in the height direction Z.

The thickness T1 of the hollow protrusion 3 is determined by the following method. In a longitudinal section including the apex P of the hollow protrusion 3 and along the height direction Z, the distance between the outer surfaces at the same position in the height direction Z is taken as the outer diameter r1, and the distance between the inner surfaces at the same position in the height direction Z is taken as the inner diameter r2. In the height direction Z of the hollow protrusion 3, the outer diameter r1 and the inner diameter r2 are measured at a position where the inner diameter r2 is greater than 0, and the thickness T1 is determined by the following formula (1).

Thickness T1=(r1-r2)/2...(1)
r1: Outer diameter r2: Inner diameter

The thickness T2 of the base portion 2 (see FIG. 2(b)) is preferably 0.01 mm or more, more preferably 0.02 mm or more, and is preferably 1.0 mm or less, more preferably 0.7 mm or less, and is 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. Thickness T2 is also the thickness of the substrate sheet 20 described later.

When the microneedle array 1 is applied to the skin to supply the liquid to the skin, in order to facilitate the supply of the liquid, the microneedle array 1 has an opening 8 on the outer surface of the hollow protrusion 3 as shown in FIG. 2(a). The opening 8 communicates with the internal space V of the hollow protrusion 3 (see FIG. 2(b)) and can be formed at any position on the outer surface of the hollow protrusion 3.

The tip diameter L of the hollow protrusion 3 (see FIG. 3) is preferably 0.001 mm or more, more preferably 0.005 mm or more, and is preferably 0.5 mm or less, more preferably 0.3 mm or less, and is preferably 0.001 mm or more and 0.5 mm or less, more preferably 0.005 mm or more and 0.3 mm or less. The tip diameter L of the hollow protrusion 3 is measured as follows.

[Measurement of tip diameter of hollow protrusion 3]
The tip of the hollow protrusion 3 is observed under magnification using a scanning electron microscope (SEM) or a microscope. For the tip of the hollow protrusion 3 observed, as shown in FIG. 3, an imaginary straight line ILa is extended along the straight line portion of one side 1a of both side sides 1a and 1b. Similarly, an imaginary straight line ILb is extended along the straight line portion of the other side side 1b. Next, on the tip side, the point where the one side side 1a departs from the imaginary straight line ILa is determined as the first tip point 1a1, and the point where the other side side 1b departs from the imaginary straight line ILb is determined as the second tip point 1b1. The length L of the straight line connecting the first tip point 1a1 and the second tip point 1b1 thus determined is measured, and this is taken as the tip diameter L of the hollow protrusion 3.

Next, the manufacturing method of the hollow protrusion device of the present invention will be described with reference to Figs. 4 to 8, taking the manufacturing method of the microneedle array 1 described above as an example. Fig. 4 shows an overview of the manufacturing method of the microneedle array 1. The hollow protrusions 3 of the microneedle array 1 are very small, but in Fig. 5, the hollow protrusions 3 are exaggerated for the sake of convenience.

First, referring to Figures 4(a) to (g), an overview of the manufacturing method of the hollow protrusion tool of this embodiment will be described. As shown in Figure 4(a), a base sheet 20 containing a thermoplastic resin is placed so as to face one side of a shaping sheet on which a shaping protrusion portion 33 having a complementary shape to the hollow protrusion tool is formed. Here, the complementary shape is not necessarily limited to a shape that fits without a gap. Then, as shown in Figures 4(b) to (c), the convex mold 43 of the convex mold portion 41 (see Figure 5) having a heating portion is abutted from the side that does not face the shaping protrusion portion 33 of the arranged base sheet 20. Then, while applying heat to the abutting portion of the convex mold portion 41 on the base sheet 20 to soften it, the convex mold portion 41 is inserted into the base sheet 20 toward the side where the base sheet 20 and the shaping protrusion portion 33 face each other. Thereafter, as shown in Figure 4(d), the inserted convex mold portion 41 is pulled out of the base sheet 20 to form a hollow protrusion portion 3 with a hollow interior. As shown in Figures 4(e) to (f), laser light 4L is irradiated from a non-contact (laser) hole-opening means arranged on the outer surface side of the shaping protrusion 33 to form an opening 8, which is a through hole, from the side of the shaping protrusion 33 and the hollow protrusion 3. Finally, as shown in Figure 4(g), the hollow protrusion 3 with the opening 8 formed therein is pulled out from the shaping protrusion 33 and released to obtain a microneedle array 1 (hollow protrusion tool). Note that holes may be opened in advance at positions in the shaping protrusion 33 corresponding to the positions of the openings 8 of the hollow protrusion 3. This makes it possible to deal with, for example, cases in which the shaping protrusion 33 is used repeatedly or cases in which it takes time to open holes in the shaping protrusion 33.

5 shows the overall configuration of a manufacturing apparatus 100 according to an embodiment used to implement the manufacturing method of the microneedle array 1. The manufacturing apparatus 100 includes a protrusion forming section (not shown) having a convex portion 41 for forming the hollow protrusion 3 in the base sheet 20, and a hole forming section 40 (laser) having a non-contact hole opening means for forming the hole 8 penetrating the hollow protrusion 3. The manufacturing apparatus 100 also includes a cooling section (not shown). The manufacturing apparatus 100 inserts the convex portion 41 from the lower surface 2B side of the base sheet 20 to form the non-penetrating hollow protrusion 3 protruding from the upper surface 2U side of the base sheet 20, and then forms the hole 8, which is a through hole, in the non-penetrating hollow protrusion 3 from the upper surface 2U side of the base sheet 20 by the hole opening means. The manufacturing method of the microneedle array 1 using the manufacturing apparatus 100 will be described in detail below.

In the method for manufacturing the microneedle array 1 using the manufacturing apparatus 100, first, as shown in FIG. 5, a strip-shaped base sheet 20 is unwound from a roll of the base sheet 20 formed containing a thermoplastic resin, and transported in the transport direction X1. Then, when the base sheet 20 has been sent to a predetermined position, the transport may be stopped once and then resumed, in an intermittent transport, or may be continuous transport in which the transport continues without being stopped. The transport means may be a known means such as a transport roll or a conveyor.

The base sheet 20, except for the portion that forms the hollow protrusion portion 3, constitutes the base portion 2 of the microneedle array 1.

The thermoplastic resin contained in the base sheet 20 may be polyfatty acid ester, polycarbonate, polypropylene, polyethylene, polyester, polyamide, polyamideimide, polyetheretherketone, polyetherimide, polystyrene, polyethylene terephthalates, polyvinyl chloride, nylon resin, acrylic resin, or a combination thereof. From the viewpoint of biodegradability, polyfatty acid ester is preferably used. Specific examples of polyfatty acid ester include polylactic acid, polyglycolic acid, or a combination thereof.

The base sheet 20 may be formed of a mixture containing hyaluronic acid, collagen, starch, cellulose, etc. in addition to a thermoplastic resin. The thickness of the base sheet 20 is equal to the thickness T2 of the base portion 2 of the microneedle array 1.

The base sheet 20 is preferably formed mainly from a thermoplastic resin. "Mainly made of a thermoplastic resin" means that it contains 50% by mass or more of a thermoplastic resin. The base sheet 20 preferably contains 50% by mass or more of a thermoplastic resin, more preferably 90% by mass or more, and even more preferably the content of the thermoplastic resin is 100% by mass. The base sheet 20 mainly made of a thermoplastic resin is usually in the form of a film.

The convex mold part 41 has a convex bottom part 42 and a plurality of convex molds 43 protruding from the convex bottom part 42. The shaping mold part 31 has a shaping bottom part 32 and a plurality of shaping protrusion parts 33 protruding from the shaping bottom part 32. That is, the convex mold part 41 and the shaping mold part 31 have a support body (convex bottom part 42, shaping bottom part 32) that serves as a base, and a portion (convex mold 43, shaping protrusion part 33) that protrudes from one side of the support body at multiple points. Not limited to such a form, either or both of the convex mold part 41 and the shaping mold part 31 may have a structure consisting only of the protruding portion (convex mold 43, shaping protrusion part 33).

The convex mold 43 provided on the convex mold portion 41 corresponds to the shape of the internal space V of the hollow protrusion portion 3 in the microneedle array 1. The outer peripheral surface 44 on the tip side of the convex mold 43 has a shape that follows the inner peripheral surface 4 of the hollow protrusion portion 3.

The shaping projection 33 of the shaping mold part 31 protrudes from the shaping bottom part 32 and is formed to be hollow inside. The shaping mold part 31 is open on the side opposite to the part of the shaping bottom part 32 where the shaping projection 33 is formed, and the opening 37 is connected to the internal space V3 of the shaping projection 33 (see FIG. 6(a)).

The shape of the internal space V3 of the shaping protrusion 33 corresponds to the external shape of the hollow protrusion 3. The inner peripheral surface 34 of the shaping protrusion 33 corresponds to the external shape of the hollow protrusion 3. The internal space V3 of the shaping protrusion 33 corresponds to the external shape of the hollow protrusion 3. In other words, the hollow protrusion 3 (microneedle array 1) and the shaping protrusion 33 have complementary shapes.

The number and arrangement of the convex molds 43 of the convex mold portion 41 and the number and arrangement of the shaping protrusions 33 of the shaping mold portion 31 correspond to the number and arrangement of the hollow protrusions 3 of the microneedle array 1. The shaping mold portion 31 is configured so that the convex mold 43 can be inserted into the internal space V3 of the shaping protrusion portion 33. Specifically, the shaping mold portion 31 is formed so that one convex mold 43 is inserted into one opening 37. The outer shape of the convex mold 43 and the shape of the internal space V3 of the shaping protrusion portion 33 are similar to each other. The size of the internal space V3 of the shaping protrusion portion 33 may be approximately the same as the outer shape of the convex mold 43, or may be slightly larger. From the viewpoint of easily inserting the convex mold 43 into the shaping protrusion portion 33, it is preferable that the central axis of each of the convex mold 43 and the shaping protrusion portion 33 is along the insertion direction in which the convex mold 43 is inserted into the shaping protrusion portion 33.

The base sheet 20 is transported with its surface parallel to the horizontal direction. As shown in FIG. 5, the convex mold section 41 is disposed above the base sheet 20 with the tip of the convex mold 43 facing the base sheet 20. The shaping mold section 31 is disposed below the base sheet 20 with the opening 37 facing the base sheet 20. The manufacturing device 100 moves each of the convex mold section 41 and the shaping mold section 31 up and down by a known lifting mechanism (not shown) using an electric actuator or the like.

The manufacturing apparatus 100 is equipped with a means for applying energy to the convex mold 43. Specifically, this means is a heating means, which is an ultrasonic vibration device equipped with an ultrasonic oscillator and an ultrasonic horn that vibrates at a predetermined ultrasonic amplitude and oscillation frequency in response to an ultrasonic signal transmitted from the ultrasonic oscillator. The ultrasonic vibration device is provided on the convex bottom 42 of the convex mold portion 41, and the ultrasonic horn vibrates the convex mold 43. Ultrasonic vibrations are applied to the base sheet 20 in contact with the convex mold 43, generating frictional heat and heating the base sheet 20.

The manufacturing apparatus 100 also includes a cooling device, such as a blower fan, that blows cool air, and a cutting device that cuts the base sheet 20. In FIG. 5, the cooling device and cutting device are omitted from the illustration, in addition to the lifting mechanism and ultrasonic vibration device described above.

The manufacturing method of the microneedle array 1 includes a sheet arrangement process in which the base sheet 20 is arranged between the convex mold portion 41 and the shaping mold portion 31, a protrusion formation process in which the convex mold 43 is inserted into the base sheet 20, a release process in which the inserted convex mold 43 is removed, an opening formation process in which an opening is formed in the formed hollow protrusion portion 3, and a demolding process in which the hollow protrusion portion 3 with the opening formed therein is released from the shaping mold portion 31.

<About the sheet placement process>
In the sheet arrangement step, the base sheet 20 is arranged on the surface side of the shaping mold part 31 (shaping sheet) on which the shaping protrusion part 33 is not formed. In the example shown in FIG. 5, the base sheet 20 is arranged between the convex mold part 41 and the shaping mold part 31 so that the convex mold 43 and the opening 37 of the shaping mold part 31 are opposed to each other across the base sheet 20. In addition, in the sheet arrangement step, the shaping protrusion part 33 may be moved by a moving means to be arranged in a position facing one side of the base sheet 20. For example, the shaping mold part 31 may be arranged on one side of the base sheet 20, and then the convex mold part 41 may be arranged on the other side, or conversely, the convex mold part 41 may be arranged on the other side of the base sheet 20, and then the shaping mold part 31 may be arranged on one side. In addition, the convex mold part 41 and the shaping mold part 31 may be arranged simultaneously. Furthermore, the base sheet 20 may be arranged so as to be fed between the convex portion 41 and the shaping portion 31 fixed at the same position in the conveying direction X1. Here, the base sheet 20 is arranged between the convex portion 41 and the shaping portion 31 such that the surface of the shaping portion 31 having the opening 37 is close to one surface of the base sheet 20.

<Protrusion Forming Process>
In the protrusion forming process, the convex mold 43 of the convex mold portion 41 is brought into contact with the base sheet 20, and while the contacting portion of the convex mold 43 is softened by heat, the convex mold 43 is inserted into the internal space V3 of the shaping protrusion portion 33 together with the base sheet 20. Then, the softened portion of the base sheet 20 is sandwiched between the outer surface of the convex mold 43 and the inner surface of the internal space V3 of the shaping protrusion portion 33 to form the hollow protrusion portion 3 (see FIGS. 6(a) and (b)).

The outer surface of the convex mold 43 is the outer surface of the convex mold 43, and includes the tip of the convex mold 43 and the surface that constitutes the outer peripheral surface 44. The inner surface of the internal space V3 of the shaping protrusion 33 is the inner surface of the shaping protrusion 33, and includes the tip that forms the surface of the internal space V3 and the surface that constitutes the inner peripheral surface 34.

With the convex mold 43 facing the opening 37 of the shaping mold portion 31 (see FIG. 6(a)), the convex mold portion 41 is lowered to insert the convex mold 43 into the base sheet 20 and into the internal space V3 of the shaping protrusion portion 33 (see FIG. 6(b)). As a result, the base sheet 20 is sandwiched between the outer surface of the convex mold 43 and the inner surface of the shaping mold portion 31 all around the periphery of the convex mold 43.

The convex mold 43 heats the base sheet 20 that it contacts with by the ultrasonic vibration device described above, so that the contacting portion is softened by the heat and becomes more easily deformed. The softened portion of the base sheet 20 is stretched as the convex mold 43 is inserted, and deforms along the outer surface of the convex mold 43 and the inner surface of the internal space V3 of the shaping protrusion 33, forming a hollow protrusion 3 having an internal space V3. The hollow protrusion 3 thus formed has an outer peripheral surface 3a that is shaped to conform to the inner peripheral surface 34 of the shaping protrusion 33. In addition, as the convex mold 43 is inserted, an opening 7 is formed on the surface of the base sheet 20 opposite the surface on which the hollow protrusion 3 is formed.

Then, when the hollow protrusion 3 is formed, the convex mold 43 is inserted into the internal space V3 of the shaping protrusion 33, and the base sheet 20 is sandwiched between the outer surface of the convex mold 43 and the inner surface of the internal space V3 of the shaping protrusion 33, and a cooling process is carried out to cool the base sheet 20 and the hollow protrusion 3. This makes it possible to easily carry out the subsequent release process. Note that this cooling process may or may not be carried out. By carrying out the cooling process, the manufacturing cycle of the microneedle array 1 can be shortened. On the other hand, if the cooling process is not carried out, the ultrasonic vibration device is stopped, and the base sheet 20 and the hollow protrusion 3 are cooled by natural cooling.

<About the release process>
In the release process, the convex mold 43 inserted into the internal space V3 of the shaping protrusion portion 33 in the protrusion forming process is pulled out from the internal space V3, and the convex mold 43 is also pulled out from inside the hollow protrusion portion 3.

<Aperture Forming Process>
Next, in the hole forming process, a through hole 8 is formed on the outer surface of the shaped protrusion 33 (hollow protrusion 3) using a hole forming means. In the hole forming process, hole processing is performed on the hollow protrusion 3 in a state where the convex mold 43 has been pulled out, that is, the hollow protrusion 3 in a state where the shaped protrusion 33 is covered. As the hole forming means, a hole forming device using a heat source such as a laser light irradiation device that irradiates laser light 4L, a hot air emission device that emits hot air, or a halogen lamp irradiation device that irradiates infrared light can be used. Since hole processing is performed on the fine hollow protrusion 3, it is preferable to use a device that enables the light collection required for hole processing and high-precision energy control as the hole forming means.

An example of such an opening processing device is a laser light irradiation device. In addition, forming the opening 8 by irradiating the laser light 4L is preferable because the opening 8 can be formed in a non-contact manner, burrs are unlikely to form around the opening 8, and the opening 8 can be easily formed at any position of the hollow protrusion 3. In addition, it is preferable to use a material having a higher absorption rate of laser light than the material of the base sheet 20 as the constituent material of the shaping protrusion 33. By using such a constituent material, the efficiency of absorbing heat by the laser light 4L increases, making it easier to form the opening 8. In addition, it is preferable to use a material having a melting point or glass transition temperature of the shaping protrusion 33 higher than the melting point or glass transition temperature of the base sheet 20. By using such a constituent material, when forming the opening 8, even if the hollow protrusion 3 may be easily bent or curved due to the influence of the melting heat when forming the through hole, the shaping protrusion 33 has the effect of suppressing deformation of the hollow protrusion 3.

As shown in FIG. 5, the laser light irradiation device (non-contact hole opening means) 4A is equipped with an irradiation head 40a, which is a galvano scanner that freely scans the laser light 4L. The irradiation head 40a is arranged on the other surface 2U side (upper surface side) of the base sheet 20 at a certain distance above the other surface 2U in the thickness direction Z. When the laser light 4L is irradiated from the irradiation head 40a arranged on the other surface 2U side of the base sheet 20 to the non-penetrating hollow protrusion 3 to form an opening 8 in the hollow protrusion 3, burrs are unlikely to be formed around the opening 8 on the outer surface of the hollow protrusion 3. In addition, since the opening 8 can be easily formed at any position in the hollow protrusion 3, it is easy to arbitrarily control the position relative to the skin surface to which the liquid agent or the like is to be supplied.

As shown in FIG. 5, the irradiation head 40a includes a lens 40c that focuses the irradiated laser light 4L, two mirrors 40b that freely scan the focused laser light 4L, and a protective lens 40d. The protective lens 40d is not necessary, but it is preferable to include it from the viewpoint of preventing dust and dirt from entering the optical system. The mirror 40b is attached to a motor shaft (not shown). The mirror 40b includes a mechanism for moving the irradiation point where the laser light 4L hits the hollow protrusion 3 on the base sheet 20 to the MD and a mechanism for moving it to the CD, so that the laser light 4L can be freely scanned. The lens 40c is movable in the optical axis direction, and includes a mechanism for focusing the laser light 4L to keep the spot diameter of the irradiation point of the laser light 4L that hits the hollow protrusion 3 constant, a mechanism for moving the irradiation point of the laser light 4L in the thickness direction Z of the base sheet 20, and the like. The irradiation head 40a having the mirror 40b and the lens 40c is adapted to adjust the irradiation point of the laser light 4L in three dimensions consisting of the X direction, the Y direction, and the Z direction. Therefore, by three-dimensionally coordinating the desired irradiation position of each of the multiple (9 in the illustrated embodiment) hollow protrusions 3, the laser light 4L can be irradiated with a predetermined spot diameter at the desired irradiation position of each hollow protrusion 3. It is preferable to use the laser light 4L that can be absorbed by the hollow protrusions 3 that form the openings 8. When the base sheet 20 that forms the hollow protrusions 3 is a sheet such as a film mainly made of a thermoplastic resin, it is preferable to use a CO2 laser, an excimer laser, an argon laser, a YAG laser, an LD laser (semiconductor laser), a YVO4 laser, a fiber laser, or the like as the laser light 4L.

<About the demolding process>
Then, in the manufacturing apparatus 100, the shaping mold part 31 is lowered to separate the shaping mold part 31 from the base sheet 20, the hollow protrusion part 3 is pulled out from within the shaping protrusion part 33, and the shaping protrusion part 33 covering the hollow protrusion part 3 is removed and released. As a result, a continuous sheet 20a in which fine hollow protrusion parts 3 having openings 8 are formed is obtained.

<About the cutting process>
The manufacturing method of this embodiment may further include a cutting step of cutting the continuous sheet 20a into a predetermined range. In the cutting step, the continuous sheet 20a is cut by the above-mentioned cutting device. This produces the microneedle array 1. As the cutting device, for example, one equipped with an anvil and a Thomson blade may be used.

For the microneedle array 1 manufactured as described above, it is also possible to omit the demolding process and use the shaping mold part 31 as a protector for the hollow protrusion part 3. In other words, it is also possible to store the microneedle array 1 without removing the shaping mold part 31 during the demolding process, and then remove the shaping mold part 31 just before using the microneedle array 1, and use it.

In addition, instead of using the shaping mold part 31 as a protective device, the microneedle array 1 may be stored with a protective device of the same shape as the shaping mold part 31 attached. That is, a protective device dedicated to protecting the hollow protrusion part 3 may be prepared, and after removing the shaping mold part 31 in the demolding process, the protective device may be attached to the hollow protrusion part 3 and the microneedle array 1 may be stored. By attaching a protective device that protects the hollow protrusion part 3 to the manufactured microneedle array 1 to make it a microneedle array 1 with a protective device (hollow protrusion device), the microneedle array 1 can be easily transported or moved, and damage to the hollow protrusion part 3 during transportation or movement can be effectively prevented.

Here, the protective equipment has a space defined therein that is complementary to the external shape of the hollow protrusion 3. That is, the shape of the protective equipment is similar to that of the shaping portion 31. The protective equipment is fitted to the hollow protrusion 3 by inserting the hollow protrusion 3 into the space inside the protective equipment. The protective equipment can be freely removed from the hollow protrusion 3, so that when using the hollow protrusion 3, the protective equipment is removed and used, and when use is completed, the protective equipment is attached to the hollow protrusion 3, allowing the hollow protrusion to be safely stored. The protective equipment is made of a material that has excellent impact resistance and heat resistance, such as metal, plastic, or resin. The protective equipment may cover the entire microneedle array 1 with one protective equipment, or may cover each of the hollow protrusions 3 individually.

In the manufacturing method of this embodiment, the softened portion of the base sheet 20 is sandwiched between the outer surface of the convex mold 43 and the inner surface of the internal space V3 of the shaping projection 33 to form the hollow projection 3, so that the dimensions of the outer diameter, thickness, etc. of the hollow projection 3, as well as the outer and inner surfaces of the hollow projection 3, can be controlled with high precision, resulting in excellent molding precision of the hollow projection 3. In addition, because the base sheet 20 is sandwiched between the convex mold 41 and the shaping mold 31 and the convex mold 43 is inserted, the hollow projection 3 can be formed while suppressing deflection of the base sheet 20.

From the viewpoint of further improving the molding accuracy of the hollow protrusion portion 3, in the protrusion forming process, it is preferable to insert the convex mold 43 into the internal space V3 of the shaping protrusion portion 33 so that the outer surface of the portion of the convex mold 43 whose outer diameter gradually increases from the tip to the base side faces the inner surface 34 of the shaping protrusion portion 33, and so that the outer surface of the convex mold 43 faces the entire inner surface 34 of the shaping protrusion portion 33. It is preferable to insert the convex mold 43 into the internal space V3 of the shaping protrusion portion 33 (see Figure 7). This makes it easier to reflect the shape of the outer surface 44 of the convex mold 43 and the inner surface 34 of the shaping protrusion portion 33 in the hollow protrusion portion 3.

The manufacturing method of this embodiment can easily adjust the thickness T1 of the hollow protrusion 3 by adjusting the insertion length L1 (see FIG. 6(b)) of the convex mold 43 into the base sheet 20. The insertion length L1 is such that the convex mold 43 does not come into contact with the shaping protrusion 33 when the convex mold 43 is inserted to the deepest depth during the protrusion forming process. In other words, the insertion length L1 of the convex mold 43 into the base sheet 20 is shorter than the height H3 (FIG. 6(a)) of the internal space V3 of the shaping protrusion 33. This makes it possible to prevent damage such as holes in the base sheet 20 and to easily control the thickness T1 of the hollow protrusion 3.

From the viewpoint of more reliably controlling the thickness T1 of the hollow protrusion portion 3, the penetration length L1 of the convex mold 43 into the base sheet 20 is preferably 50% or more, more preferably 70% or more, and also preferably 99% or less, more preferably 95% or less, and also preferably 50% or more and 99% or less, more preferably 70% or more and 95% or less, of the height H3 of the internal space V3 of the shaping protrusion portion 33. The height H3 of the internal space V3 of the shaping protrusion portion 33 is the height from the surface having the opening 37 in the shaping mold portion 31 to the tip of the internal space V3 of the shaping protrusion portion 33.

From the same viewpoint as above, the speed at which the convex mold 43 is inserted into the shaping projection 33, i.e., the insertion speed at which the convex mold 43 is inserted into the base sheet 20, is preferably 0.1 mm/sec or more, more preferably 1 mm/sec or more, and also preferably 1000 mm/sec or less, more preferably 800 mm/sec or less, and also 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. The insertion speed can be adjusted by the descent speed (movement speed) of the convex mold portion 41 of the lifting mechanism that controls the elevation of the convex mold portion 41.

From the viewpoint of further improving the molding accuracy of the hollow protrusion 3, it is preferable to arrange the central axis of the shaping protrusion 33 and the central axis of the convex mold 43 on the same axis AX in the protrusion forming process, and insert the convex mold 43 into the internal space V3 of the shaping protrusion 33. By arranging the central axes of the convex mold 43 and the shaping protrusion 33 on the same axis AX, the thickness T1 and shape of the hollow protrusion 3 can be made uniform in the circumferential direction of the central axis, and the strength of the hollow protrusion 3 can be further improved.

From the viewpoint of efficiently forming the hollow protrusions 3, the heating temperature of the base sheet 20 by the convex mold 43 is preferably equal to or higher than the glass transition temperature and lower than the melting temperature of the base sheet 20, and more preferably equal to or higher than the softening temperature and lower than the melting temperature. From the same viewpoint as above, the heating temperature is preferably equal to or higher than 30°C, more preferably equal to or higher than 40°C, and also preferably equal to or lower than 300°C, more preferably equal to or lower than 250°C, and also preferably equal to or higher than 30°C and lower than 300°C, more preferably equal to or higher than 40°C and lower than 250°C.

The glass transition temperature (Tg) of the base sheet 20 means the glass transition temperature (Tg) of the constituent resin of the base sheet 20. When the base sheet 20 has multiple constituent resins and the multiple glass transition temperatures (Tg) are different from each other, the heating temperature of the base sheet 20 is preferably at least equal to or higher than the lowest glass transition temperature of the multiple glass transition temperatures, and is preferably equal to or higher than the highest glass transition temperature of the multiple glass transition temperatures.

The softening temperature of the base sheet 20 means the softening temperature of the constituent resin of the base sheet 20. When the base sheet 20 has multiple constituent resins and the softening temperatures of the multiple resins are different from each other, it is preferable that the heating temperature of the base sheet 20 is at least equal to or higher than the lowest softening temperature of the multiple softening temperatures, and it is more preferable that the heating temperature is equal to or higher than the highest softening temperature of the multiple softening temperatures.

The melting point of the base sheet 20 means the melting point of the constituent resin of the base sheet 20. When the base sheet 20 is composed of two or more constituent resins with different melting points, it is preferable that the heating temperature of the base sheet 20 is lower than the lowest melting point among the multiple melting points.

In this embodiment, the heating temperature is adjusted by the oscillation frequency and ultrasonic amplitude of the ultrasonic vibration device. The glass transition temperature (Tg) is measured by the following method, and the softening temperature is measured in accordance with JIS K-7196 "Softening temperature test method by thermomechanical analysis of thermoplastic plastic films and sheets."

[Method of measuring glass transition temperature (Tg)]
The calorific value is measured using a DSC measuring device to determine the glass transition temperature. A differential scanning calorimeter (Diamond DSC) manufactured by Perkin Elmer is used as the measuring device. A 10 mg test piece is taken from the base sheet 20. The measurement conditions are: after isothermal at 20°C for 5 minutes, the temperature is increased from 20°C to 320°C at a rate of 5°C/min, and a DSC curve with the horizontal axis being temperature and the vertical axis being calorific value is obtained. The glass transition temperature Tg is then obtained from this DSC curve.

In the protrusion forming process of this embodiment, the heated convex mold 43 is stopped when it is inserted to the deepest point, and the convex mold portion 41 is maintained in the hollow protrusion portion 3 for a predetermined time. In this way, the softening time for softening the base sheet 20 is set. From the viewpoint of preventing overheating or underheating, the softening time is preferably more than 0 seconds, more preferably 0.1 seconds or more, and also preferably 10 seconds or less, more preferably 5 seconds or less, and also preferably more than 0 seconds and 10 seconds or less, more preferably 0.1 seconds or more and 5 seconds or less. The softening time is the time from when the heated convex mold 43 is inserted to the deepest point until the next process (cooling process).

The height H2 of the convex mold 43 of the convex mold portion 41 is formed to be approximately the same as the protruding height H1 of the hollow protrusion 3 or slightly higher. From the viewpoint of forming the hollow protrusion 3 with higher precision, it is preferable that the dimensions of the convex mold 43 are within the following range.

The height H2 of the convex mold 43 is preferably 0.01 mm or more, more preferably 0.02 mm or more, and is preferably 30 mm or less, more preferably 20 mm or less, and is preferably 0.01 mm or more and 30 mm or less, more preferably 0.02 mm or more and 20 mm or less.

The tip diameter D1 of the convex shape 43 of the convex shape portion 41 is preferably 0.001 mm or more, more preferably 0.005 mm or more, and is preferably 1 mm or less, more preferably 0.5 mm or less, and is preferably 0.001 mm or more and 1 mm or less, more preferably 0.005 mm or more and 0.5 mm or less. The tip diameter D1 (see FIG. 8) of the convex shape 43 of the convex shape portion 41 is measured as follows.

[Measurement of tip diameter D1 of convex mold 43]
The tip of the convex mold 43 of the convex mold portion 41 is observed under magnification using a scanning electron microscope (SEM) or a microscope. For the tip of the observed convex mold 43, as shown in Fig. 8, an imaginary straight line ILc is extended along the straight line portion of one side 11a of both side sides 11a and 11b, and an imaginary straight line ILd is extended along the straight line portion of the other side side 11b. Next, on the tip side, the point where the one side side 11a departs from the imaginary straight line ILc is determined as a first tip point 11a1, and the length D1 of the straight line connecting the point where the other side side 11b departs from the imaginary straight line ILd to the second tip point 11b1 is measured, and this is defined as the tip diameter D1 of the convex mold 43.

The protruding mold 43 of the protruding portion 41 has a base diameter D2 of preferably 0.1 mm or more, more preferably 0.2 mm or more, and also preferably 5 mm or less, more preferably 3 mm or less, and also preferably 0.1 mm or more and 5 mm or less, more preferably 0.2 mm or more and 3 mm or less. The base diameter D2 of the protruding mold 43 is the outer diameter of the part opposite the tip of the protruding mold 43, where the outer diameter is constant.

From the viewpoint of ensuring strength more reliably and making it easier to obtain an appropriate angle, the tip angle α (see FIG. 8) of the convex mold 43 is preferably 1 degree or more, more preferably 5 degrees or more, and preferably 60 degrees or less, more preferably 45 degrees or less, and preferably 1 degree or more and 60 degrees or less, more preferably 5 degrees or more and 45 degrees or less. The tip angle α of the convex mold portion 41 is measured as follows.

[Measurement of tip angle α of convex mold 43]
The tip of the convex mold 43 is enlarged and observed, and imaginary straight lines ILc and ILd are extended along both sides 11a and 11b of the tip in the same manner as in the measurement of the tip diameter of the convex mold 43 described above. The angle formed by the imaginary straight lines ILc and ILd is measured, and this angle is defined as the tip angle α of the convex mold 43.

In this embodiment, the height H3 (see FIG. 6(a)) of the internal space V3 of the shaping protrusion 33 is formed slightly higher than the protruding height H1 of the hollow protrusion 3. From the viewpoint of forming the hollow protrusion 3 with higher precision, it is preferable that the dimensions of the shaping protrusion 33 are within the following range.

The height H3 of the internal space V3 of the shaping protrusion 33 is preferably 0.015 mm or more, more preferably 0.02 mm or more, and is preferably 11 mm or less, more preferably 5 mm or less, and is preferably 0.015 mm or more and 11 mm or less, more preferably 0.02 mm or more and 5 mm or less.

It is preferable that the tip diameter, base diameter, and tip angle of the shaping projection 33 are each within the preferred range of the convex mold 43 described above. The tip diameter, base diameter, and tip angle can each be measured using a method similar to the method for measuring the tip diameter D1, base diameter D2, and tip angle α of the convex mold 43 described above.

The convex portion 41 is formed of a high-strength material that is difficult to break. Examples of materials for the convex portion 41 include metals such as steel, stainless steel, aluminum, aluminum alloy, nickel, nickel alloy, cobalt, cobalt alloy, copper, copper alloy, beryllium copper, beryllium copper alloy, and ceramics.

The shaping portion 31 may be made of the same material as the convex portion 41, or may be made of a different material.

From the viewpoint of easily forming the shaping portion 31 and further reducing manufacturing costs, it is preferable that the shaping portion 31 is formed mainly from a thermoplastic resin. As the thermoplastic resin, the above-mentioned ones can be used without any particular restrictions. It is preferable to use a thermoplastic resin whose melting point is higher than the melting point of the thermoplastic resin contained in the base sheet 20 as the thermoplastic resin contained in the shaping portion 31.

When the shaping mold portion 31 is formed mainly from a thermoplastic resin, it is more preferable that the glass transition temperature (Tg) of the resin constituting the shaping mold portion 31 is higher than the glass transition temperature (Tg) of the resin constituting the base sheet 20, in order to further prevent the shaping mold portion 31 from being deformed and the shaping mold portion 31 from being welded to the base sheet 20 by heating the convex mold 43 in the protrusion forming process.

From the same viewpoint as above, assuming that the glass transition temperature of the constituent resin of the shaping mold portion 31 is higher than the glass transition temperature of the constituent resin of the base sheet 20, the difference between the glass transition temperature of the constituent resin of the shaping mold portion 31 and the glass transition temperature of the constituent resin of the base sheet 20 is preferably 5°C or more, more preferably 10°C or more, and also preferably 50°C or less, more preferably 30°C or less, and also preferably 5°C or more and 50°C or less, more preferably 10°C or more and 30°C or less.

An example of a combination of constituent resins that satisfies the above glass transition temperature is a combination in which the constituent resin of the shaping portion 31 is polyethylene terephthalate (PET) and the constituent resin of the base sheet 20 is polylactic acid (PLA).

[Second embodiment]
Next, a manufacturing method according to a second embodiment of the present invention will be described with reference to Figures 9 to 11. The manufacturing method according to this embodiment differs from the first embodiment in that it includes a shaping mold forming step and a shaping mold preparing step before the sheet arrangement step. The other steps and equipment configurations are the same as those in the first embodiment, so detailed descriptions of the same steps and equipment configurations will be omitted.

With reference to FIG. 9, an overview of the manufacturing method according to this embodiment will be described. Note that FIG. 9(d)-(j) are the same steps as FIG. 4(a)-(g). The manufacturing method according to this embodiment includes a shaping mold forming step and a shaping mold preparing step before the installation step of the manufacturing method according to the first embodiment described above. First, a shaping convex mold 53 having a heating section is abutted against one side of a shaping sheet 30 containing a thermoplastic resin, and while the abutting portion of the shaping sheet 30 is softened by heat, the shaping convex mold 53 is inserted into the shaping sheet 30 (see FIG. 9(a)-(b)) (shaping mold forming step). After that, the inserted shaping convex mold 53 is pulled out of the shaping sheet 30, and a shaping protrusion 33 protruding from the other side of the shaping sheet 30 and hollow inside is prepared (see FIG. 9(c)) (shaping mold preparing step).

Next, the manufacturing method according to this embodiment will be described in detail with reference to Figures 10 to 11. The shaping mold forming process is a process in which a shaping convex mold 53 is brought into contact with one side of a shaping sheet 30 (shaping mold sheet) that contains a thermoplastic resin and is the raw material of the shaping mold portion 31, and the shaping convex mold 53 is inserted into the shaping sheet 30 while the contacting portion of the shaping sheet 30 is softened by heat, forming the shaping protrusion portion 33. The shaping mold preparation process is a process in which the shaping convex mold 53 is pulled out from inside the shaping protrusion portion 33, and the shaping convex mold portion 51 is prepared for the sheet arrangement process.

<About the mold forming process>
In the forming process, the convex mold 53 is brought into contact with one side of the sheet for forming the mold, which contains a thermoplastic resin and is the raw material of the forming mold part 31, and the convex mold 53 is inserted into the sheet for forming the mold while the contacting part of the sheet for forming the mold is softened by heat to form the forming mold. In addition, in the forming process, a convex mold part 51 for forming the mold having a plurality of convex molds 53 is used. The outer shape of the convex mold 53 corresponds to the outer shape of the shaping protrusion part 33. The number and arrangement of the convex molds 53 of the convex mold part 51 for forming the mold corresponds to the number and arrangement of the shaping protrusion part 33 of the forming mold part 31. The convex mold part 51 for forming the mold may have the same configuration as the convex mold part 41 described above, or may have a configuration with some different dimensions from the convex mold part 41. In this embodiment, the convex mold part 41 described above is used as the convex mold part 51 for forming the mold.

In this embodiment, the convex mold portion 41 (shaping convex mold portion 51) is lowered to insert the convex mold 43 (shaping convex mold 53) into the shaping sheet 30 (see FIG. 10) (shaping sheet protrusion forming process). The convex mold 43 is inserted into the shaping sheet 30 while heating the contact portion with the shaping sheet 30 by the ultrasonic vibration device described above. As a result, the shaping sheet 30 is softened, and the softened portion is stretched with the insertion of the convex mold 43, forming the shaping protrusion portion 33. In addition, with the insertion of the convex mold 43, an opening 37 is formed on the surface of the shaping sheet 30 (shaping bottom portion 32) opposite to the surface on which the shaping protrusion portion 33 is formed. In addition, the convex mold portion 41 (shaping convex mold portion 51) may move up and down at the same position (fixed position) instead of moving following the shaping sheet 30. In that case, the shaping sheet 30 is conveyed intermittently. By carrying out the intermittent conveyance, the positional accuracy of the convex mold portion 41 (shaping convex mold portion 51) is improved, and the hollow protrusion tool 1 with good moldability can be manufactured.

From the viewpoint of the formability of the shaping protrusion portion 33 and shortening the molding cycle, the shaping sheet protrusion forming process preferably includes a shaping protrusion cooling process for cooling the shaping protrusion portion 33. The shaping protrusion cooling process cools the shaping sheet 30 and the shaping protrusion portion 33 in a state where the convex mold 43 (shaping convex mold 53) is inserted into the shaping sheet 30, i.e., in a state where the convex mold 43 (shaping convex mold 53) is inserted into the internal space V3 of the shaping protrusion portion 33.

<About the mold preparation process>
In the shaping mold preparation process, the convex mold 43 (shaping convex mold 53) inserted into the shaping sheet 30 in the shaping sheet projection forming process, i.e., the convex mold 43 (shaping convex mold 53) inserted inside the shaping projection portion 33, is pulled out from the shaping projection portion 33. In this embodiment, similar to the shaping sheet projection forming process, the convex mold portion 41 (shaping convex mold portion 51) is raised to pull out the convex mold 43 (shaping convex mold 53) from inside the shaping projection portion 33. This results in the shaping mold portion 31 with the shaping projection portion 33 formed therein. Then, preparation of the shaping mold portion 31 for use in the sheet arrangement process of the first embodiment is completed.

Various conditions can be applied as appropriate to the shaping sheet projection forming process and the shaping mold preparation process. For example, the softening time for softening the base sheet 20 may be applied as the time for softening the shaping sheet 30. Also, for example, if the constituent resin of the shaping mold portion 31 (shaping sheet 30) has a higher glass transition temperature (Tg) than the constituent resin of the base sheet 20, the heating temperature by the shaping convex mold 53 may be higher than the heating temperature by the convex mold 43.

The shaping mold part 31 obtained by the shaping sheet protrusion forming process may be used repeatedly in the protrusion forming process of the first embodiment, and one shaping mold part 31 may be used for one protrusion forming process. When the shaping mold part 31 is used repeatedly, the shaping mold part 31 may be replaced every predetermined number of times.

Figure 11 shows another example of the shaping sheet protrusion forming process. In the shaping sheet protrusion forming process shown in Figure 10, the shaping protrusion portion 33 was formed on the shaping sheet 30 in a single sheet, but in this example, the shaping protrusion portion 33 is formed on a strip-shaped shaping sheet 30a. The shaping sheet 30a is a strip-shaped sheet that continues in one direction, and the shaping protrusion portion 33 is formed sequentially along the longitudinal direction of the shaping sheet 30a. The longitudinal direction of the shaping sheet 30a coincides with the conveying direction X2 of the shaping sheet 30a, and the shaping protrusion portion 33 is formed continuously along the conveying direction X2. In this embodiment, after the shaping mold preparation process, a continuous shaping mold portion 31a is obtained in which multiple shaping protrusion portions 33 are formed continuously in the longitudinal direction of the shaping sheet 30a. The shaping mold portion 31 is obtained by cutting the continuous shaping mold portion 31a into a predetermined range. The cutting device described above can be used to cut the continuous shaping mold portion 31a.

1. Microneedle array (hollow protrusion device)
Reference Signs List 2 Base portion 3 Hollow protrusion portion 4A Laser light irradiation device 4L Laser light 7 Opening 8 Opening 20 Base sheet 30 Shaping sheet 31 Shaping mold portion 32 Shaping bottom portion 33 Shaping protrusion portion 34 Inner peripheral surface 37 Opening 40 Opening forming portion 40a Irradiation head 40b Mirror 40c Lens 40d Protective lens 41 Convex mold portion 42 Convex mold bottom portion 43 Convex mold 51 Shaping convex mold portion 53 Shaping convex mold 100 Manufacturing device V Internal space V3 Internal space X1 Transport direction Z Height direction

Claims (10)

A method for manufacturing a hollow protrusion tool having a hollow protrusion portion having an opening, comprising the steps of:
A sheet arrangement step of arranging a base sheet containing a thermoplastic resin so as to face a shaping mold having a complementary shape to the hollow protrusion tool;
a projection forming step of contacting a convex portion having a heating portion with the base sheet from a surface side of the base sheet that does not face the shaping mold, and inserting the convex portion into the base sheet toward the shaping mold while softening the contact portion of the base sheet with the heat;
a release step of pulling the convex portion out of the base sheet to form the hollow protrusion portion;
an opening forming step of forming the opening penetrating the shaping mold and the hollow protrusion;
A method for manufacturing a hollow protruding tool comprising the steps of: The method for manufacturing a hollow protrusion tool according to claim 1 further includes a demolding step of demolding the hollow protrusion portion in which the opening is formed from the shaping mold. A mold forming step of contacting a convex mold part having a heating part with one side of a mold sheet containing a thermoplastic resin and serving as a raw material for the mold, and forming the mold by inserting the convex mold part into the mold sheet while softening the contacting part of the mold sheet by heat;
A forming mold preparation process in which the forming convex portion is pulled out from the forming mold to prepare the forming mold for the sheet arrangement process;
The method for manufacturing a hollow protrusion tool according to claim 1 or 2, further comprising the steps of: The method for manufacturing a hollow protrusion tool according to claim 3, in which the convex mold part is used as the shaping convex mold part. The method for manufacturing a hollow protrusion tool according to any one of claims 1 to 4, wherein the hole is formed by a non-contact hole forming means in the hole forming step. The method for manufacturing a hollow protrusion tool according to claim 5, wherein the hole is formed by irradiating a laser beam in the hole forming step. The method for manufacturing a hollow protrusion tool according to claim 6, wherein the material constituting the shaping mold has a higher absorption rate for the laser light than the material constituting the base sheet. The method for manufacturing a hollow protrusion tool according to any one of claims 1 to 7, in which the base sheet is heated by ultrasonically vibrating the convex portion. The method for manufacturing a hollow protrusion tool according to any one of claims 1 to 8, wherein the thermoplastic resin contained in the shaping mold has a glass transition point higher than the glass transition point of the thermoplastic resin contained in the base sheet. The method for manufacturing a hollow protrusion tool according to any one of claims 1 to 9, wherein the thermoplastic resin contained in the shaping mold has a melting point higher than the melting point of the thermoplastic resin contained in the base sheet.

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