JP2023091681A - Hollow protrusion tool manufacturing method and hollow protrusion tool - Google Patents

Abstract

To provide a hollow protrusion tool manufacturing method that can supply an agent to a desired region with pinpoint accuracy.SOLUTION: A hollow protrusion tool manufacturing method has an opening forming process for forming an opening 8 to penetrate through a sidewall 31 of a hollow protrusion part 3 by non-contact type opening means 6A in the hollow protrusion part 3, the hollow protrusion tool including a hollow protrusion part. The hollow protrusion tool manufacturing method comprises: a sheet lamination step of forming a laminated sheet 4 by laminating a base material sheet 20 and a forming auxiliary sheet 21 being higher than the base material sheet 20 in an absorption factor of energy applied by the opening means 6A; a protrusion forming step of bringing a convex shape part 51 into abutment with the laminated sheet 4 from the forming auxiliary sheet 21 side, and piercing the convex shape part 51 into the laminated sheet 4 toward the base material sheet 20 side; a release step of pulling up the convex shape part 51 from the laminated sheet 4, and forming a hollow protrusion part 3; and a separation step of separating the hollow protrusion part 3 with the opening 8 formed therein from the forming auxiliary sheet 21. The opening forming step is performed after the release step.SELECTED DRAWING: Figure 7

Description

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

In the medical or cosmetic field, microneedle technology is known that can supply agents without pain by puncturing a superficial layer of the skin with a microneedle. are being considered from. For example, in Patent Document 1, a protrusion forming portion is inserted from one side of a base sheet to form non-penetrating hollow protrusions, and a laser beam is irradiated from the other side of the base sheet to open. Techniques for forming holes are disclosed. In addition, Patent Document 2 discloses a technique of forming fine hollow projections by pointing a convex shape in a layered portion of another material in which a base sheet formed of a first material and a second material are layered. It is Further, in Patent Document 3, a needle-shaped body having a substrate and projections formed on one surface of the substrate is irradiated with a laser beam from the other surface side of the substrate to obtain the substrate and the projections. A technique is disclosed for forming a through-hole penetrating both the part and the part.

JP 2019-50927 A JP 2019-205767 A International Publication No. 2015-125475

In the technique described in Patent Document 1, the opening formed in the hollow protrusion has a larger opening area on the outer surface of the side wall of the hollow protrusion than on the inner surface of the side wall. Therefore, in the microneedle manufactured by the technique described in the same document, the agent coming out of the opening on the outer surface of the side wall through the opening is released over a wide range, so that it can However, it was difficult to inject the agent into the desired site with pinpoint accuracy.
In the technique described in Patent Literature 3, a through hole is formed along the projecting direction of the projecting portion. Therefore, the agent released from the through-hole spreads in the projecting direction, making it difficult to inject the agent into a desired site with pinpoint accuracy.
Japanese Patent Laid-Open No. 2002-200003 does not describe forming openings in the fine hollow projections.
SUMMARY OF THE INVENTION Accordingly, an object of the present invention is to provide a hollow projection device capable of pinpoint injection into a desired site, and a method for manufacturing the same.

TECHNICAL FIELD The present invention relates to a method for manufacturing a hollow protrusion, comprising a hole forming step of forming holes penetrating through the side wall of a fine hollow protrusion by non-contact hole forming means.
In the method for manufacturing the hollow protrusion, a base sheet containing a thermoplastic resin and a molding auxiliary sheet having a higher absorption rate of energy applied by the perforating means than the base sheet are laminated to form a laminated sheet. a sheet lamination process to
A convex portion having a heating portion is brought into contact with the laminated sheet from the auxiliary forming sheet side, and while the contact portion of the convex portion in the laminated sheet is softened by heat, it is directed toward the base sheet side. a projection forming step of inserting the convex portion into the laminated sheet;
a release step of pulling out the convex portion from the laminated sheet;
the opening forming step performed after the releasing step;
It is preferable to include a separation step of separating the hollow protrusions and the auxiliary forming sheet after the opening forming step.

The present invention also relates to a hollow protrusion having fine hollow protrusions with openings.
Preferably, the aperture penetrates the side wall of the hollow protrusion.
It is preferable that the area of one of the openings located on the outer surface of the side wall is smaller than the area of the other opening located on the inner surface of the side wall.

According to the method for manufacturing a hollow projection device and the hollow projection device of the present invention, it is possible to provide a hollow projection device capable of pinpoint injection into a desired site.

FIG. 1 is a perspective view showing an example of a hollow protrusion (microneedle array) manufactured by the manufacturing method of the present invention. 2 is a perspective view of one hollow protrusion shown in FIG. 1; FIG. FIG. 3(a) is a cross-sectional view taken along line III-III shown in FIG. 2, and FIG. 3(b) is an explanatory view showing a method of measuring the tip diameter of the hollow protrusion. 4 is a cross-sectional view schematically showing a state in which the hollow projection part of the hollow projection device shown in FIG. 1 is inserted into the skin; FIG. FIG. 5 is a diagram showing the overall configuration of a preferred embodiment for manufacturing the hollow projection device shown in FIG. FIG. 6 is an explanatory diagram showing a method of measuring the tip diameter and tip angle of the convex portion. 7(a) to (g) are diagrams for explaining a manufacturing method for manufacturing the hollow protrusion shown in FIG. 1 using the manufacturing apparatus shown in FIG. FIGS. 8(a) to 8(d) are diagrams for explaining the mechanism by which holes are formed in hollow protrusions when lamination protrusions are irradiated with a laser.

BEST MODE FOR CARRYING OUT THE INVENTION Hereinafter, the present invention will be described based on its preferred embodiments with reference to the drawings. First, an embodiment of the hollow projection device obtained by the manufacturing method of the present invention will be described with reference to FIGS. 1 to 4. FIG.

[First embodiment]
FIG. 1 shows a microneedle array 1 (hollow projection device), which is an embodiment of a hollow projection device having fine hollow projections. The microneedle array 1 of this embodiment has a sheet-like base portion 2 and a plurality of hollow protrusions 3 , and openings 8 are provided in side walls 31 of the hollow protrusions 3 . The hollow protruding portion 3 protrudes from the base portion 2 and has a hollow interior. The opening 8 is formed in a portion surrounding the hollow portion of the hollow projection portion 3 and positioned closer to the base portion 2 than the apex position of the hollow portion. The microneedle array 1 is opened on the opposite side of the portion of the base 2 where the hollow projections 3 are formed, and an opening 7 (see FIG. 3(a)) is formed. The opening 7 and the internal space V of the hollow protrusion 3 (see FIG. 3(a)) communicate with each other. The internal space V of the hollow protrusion 3 is formed in a conical shape corresponding to the outer shape of the hollow protrusion 3 . That is, the inner peripheral surface of the hollow protrusion 3 has a shape corresponding to the outer peripheral surface of the hollow protrusion 3 . The shape of the hollow protrusion 3 can be any shape such as a cone, a truncated cone, a cylinder, a prism, a pyramid, or a truncated pyramid.

The microneedle array 1 has a plurality of truncated conical hollow projections 3 in an array (matrix) on the upper surface of a base 2 . Specifically, nine hollow protrusions 3 are arranged in an array, and three rows in the direction Y along the direction Y1 (longitudinal direction of the base sheet 20) in which the base sheet 20 is conveyed (to be described later). They are arranged in three rows in a direction X perpendicular to Y. The direction X is a direction (the width direction of the base sheet 20) perpendicular to the direction Y1 in which the base sheet 20 is conveyed. 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 tips of the hollow protrusions 3 can be pierced as far as the stratum corneum at the shallowest point and as far as the dermis or subcutaneous tissue at the deepest point. From this point of view, the projection height H1 (see FIG. 3(a)) of the hollow projection 3 is preferably 0.01 mm or more, more preferably 0.02 mm or more, and preferably 10 mm or less. It is preferably 5 mm or less, more 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 and an imaginary line P1 parallel to the upper surface 2U of the base portion 2 from which the hollow protrusion 3 protrudes and passing through the vertex P of the hollow protrusion 3 . If the upper surface 2U is not flat but has wavy unevenness, the height direction Z of the hollow protrusion 3 is aligned with the vertical direction, and then the imaginary line P1 passes through the vertex P and is parallel to the horizontal direction. line. The distance between the imaginary line P1 and the top of the convex portion of the unevenness on the side of the upper surface 2U is defined as a protrusion height H1. The distance (projection height H1) between the virtual line P1 and the upper surface 2U is measured by magnifying and observing the hollow projection 3 using a scanning electron microscope (SEM) or a microscope.

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

The thickness T1 of the hollow protrusion 3 is obtained by the following method. In a longitudinal section including the vertex 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 defined as the outer diameter r1, and the distance between the inner surfaces at the same position in the height direction Z. is 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 obtained by the following formula (1).
Thickness T1=(r1-r2)/2 (1)
r1: outer diameter r2: inner diameter

The thickness T2 (see FIG. 3(a)) of the base portion 2 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, 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. The thickness T2 is also the thickness of the base sheet 20, which will be described later.

The hollow protrusion 3 has an aperture 8 . The opening 8 is provided through the side wall 31 of the hollow protrusion 3 . The opening 8 communicates with the internal space V of the hollow protrusion 3 (see FIG. 3A), and can be formed at any position on the outer surface of the hollow protrusion 3 . One opening 8 a of the aperture 8 is positioned on the outer surface 31 a of the side wall 31 . The other opening 8b of the aperture 8 is located on the inner surface 31b of the side wall 31. As shown in FIG.

A pair of openings 8a and 8b of the opening 8 have different opening areas. Specifically, the area Sa of one opening 8a positioned on the outer surface 31a of the side wall 31 is smaller than the area Sb of the other opening 8b positioned on the inner surface 31b of the side wall 31 . The advantages of forming the opening 8 in the side wall 31 and having such a relationship between the area Sa of the opening 8a and the area Sb of the opening 8b are as follows.
For example, as shown in FIG. 4, when the hollow protrusions 3 of the microneedle array 1 are pierced into the epidermis S1 of the skin S and the agent is injected into the epidermis S1, the agent is injected into the openings having relatively large opening areas. It enters the opening 8 from 8b and is released from the opening 8a having a relatively small opening area. The relatively small opening area of the opening 8a, which is the outlet through which the agent is released, makes it difficult for the released agent to spread, so that the agent can be pinpointed into the epidermis S1. FIG. 4 shows an example of supplying the agent to the epidermis S1, but the site to which the agent is supplied is not limited to the epidermis S1. It may be a vein (not shown) or the like. When one opening is located in the side wall of the protrusion and the other opening is located in the base like the through-hole of the protrusion in Patent Document 3, the through-hole extends along the protrusion direction of the protrusion. As a result, the agent released from the through-hole spreads in the projecting direction, making it difficult to inject the agent into a desired site with pinpoint accuracy.

From the viewpoint of more pinpoint supply of the agent, the ratio Sa/Sb of the area Sa of the opening 8a located on the outer surface 31a of the side wall 31 to the area Sb of the opening 8b located on the inner surface 31b of the side wall 31 is preferably 1 or less, more preferably 0.9 or less, still more preferably 0.8 or less, and from the viewpoint of ensuring the strength of the side wall 31 around the opening 8, preferably 0.001 or more, more preferably 0.004 or more, more preferably 0.01 or more, preferably 0.001 or more and 1 or less, more preferably 0.004 or more and 0.9 or less, still more preferably 0.01 or more from the viewpoint of compatibility of these 0.8 or less.

The hole 8 of the hollow protrusion 3 may have an inner diameter that gradually decreases from the inner surface 31b side of the side wall 31 toward the outer surface 31a side. From the standpoint of this, it is preferable that the inner diameter of the side wall 31 gradually decreases from the inner surface 31b side toward the outer surface 31a side.

Further, in the present embodiment, the angle α between the central axis L1 of the hollow protrusion 3 and the opening 8 is preferably 15 degrees or more, more preferably 25 degrees or more, and still more preferably 30 degrees or more. 90 degrees or less, more preferably 80 degrees or less, still more preferably 65 degrees or less, preferably 15 degrees or more and 90 degrees or less, more preferably 80 degrees or more and 65 degrees or less, still more preferably 30 degrees or more and 65 degrees or less be. By setting each α within the above range, the agent released from the openings 8 tends to spread in the direction perpendicular to the projecting direction of the hollow protrusions 3, so that the agent can be more pinpointed. will be able to The angle α means an angle between the central axis L1 and an imaginary straight line L2 connecting the centroid Qa of the opening 8a and the centroid Qb of the opening 8b.

The tip diameter L (see FIG. 3(b)) 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, more preferably It is 0.3 mm or less, 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 enlarged and observed using a scanning electron microscope (SEM) or a microscope. As shown in FIG. 3, an imaginary straight line ILa is extended along one side 1a of the two sides 1a and 1b of the observed tip of the hollow projection 3. FIG. Similarly, an imaginary straight line ILb is extended along the straight portion of the other side 1b. Next, on the leading end side, the point where one side 1a separates from the imaginary straight line ILa is determined as the first point 1a1, and the point where the other side 1b separates from the imaginary line ILb is determined as the second 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 is measured, and this is taken as the tip diameter L of the hollow protrusion 3. FIG.

Next, a preferred embodiment of the method for manufacturing the hollow projection device of the present invention will be described with reference to FIGS. 5 to 7, taking the aforementioned method for manufacturing the microneedle array 1 as an example. FIG. 5 shows the overall configuration of a manufacturing apparatus 100 of one embodiment used for carrying out the manufacturing method of this embodiment. As described above, each hollow protrusion 3 of the microneedle array 1 is very small, but for convenience of explanation, each hollow protrusion 3 of the microneedle array 1 is drawn very large in FIG. ing.

As shown in FIG. 5 , the manufacturing apparatus 100 has a sheet stacking unit 40 that stacks the base sheet 20 and a molding auxiliary sheet 21 to be described later to form the laminated sheet 4 , and forms the hollow protrusions 3 on the base sheet 20 . and an aperture forming portion 60 having non-contact aperture means 6A for forming apertures 8 passing through the hollow protrusion 3. .

The method for manufacturing the microneedle array 1 using the manufacturing apparatus 100 includes an opening forming step of forming openings 8 penetrating the side walls 31 of the fine hollow protrusions 3 by non-contact opening means 6A. have. Further, the method for manufacturing the microneedle array 1 includes a sheet lamination process, a protrusion formation process, a release process, and a separation process. In this embodiment, the opening forming step is performed after the releasing step. Moreover, a separation process is performed after an opening formation process.

In this embodiment, first, as shown in FIG. 5 , a strip-shaped base sheet 20 is unwound from a roll of a base sheet 20 containing a thermoplastic resin and conveyed in the conveying direction Y. As shown in FIG. Separately from this, the belt-shaped forming auxiliary sheet 21 is drawn out from the raw fabric roll of the forming auxiliary sheet 21 and conveyed in the conveying direction Y. As shown in FIG. The method of conveying the base sheet 20 and the auxiliary forming sheet 21 may be intermittent conveyance in which the conveyance is once stopped when the base sheet 20 is conveyed to a predetermined position, and then the conveyance is restarted. It may be a continuous transfer in which the transfer is continued without stopping. As the conveying means, known means such as conveying rolls or conveyors can be used.

A portion of the base sheet 20 other than the portion forming the hollow protrusions 3 constitutes the base portion 2 of the microneedle array 1 .
Thermoplastic resins contained in the base sheet 20 include poly fatty acid ester, polycarbonate, polypropylene, polyethylene, polyester, polyamide, polyamideimide, polyetheretherketone, polyetherimide, polystyrene, polyethylene terephthalates (PET), and polyvinyl chloride. , nylon resins, acrylic resins, etc., or a combination thereof, and poly-fatty acid esters are preferably used from the viewpoint of biodegradability. Specific examples of polyfatty acid esters include polylactic acid (PLA), polyglycolic acid, and combinations thereof.

The base sheet 20 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 20 is equivalent to the thickness T2 of the base portion 2 of the microneedle array 1 .

The base sheet 20 is preferably formed mainly of a thermoplastic resin. The phrase "mainly composed of a thermoplastic resin" means that the thermoplastic resin is contained in an amount of 50% by mass or more. The base sheet 20 preferably contains 50% by mass or more, more preferably 90% by mass or more, and more preferably 100% by mass of the thermoplastic resin. The base sheet 20, which is mainly made of thermoplastic resin, is usually in the form of a film.

The auxiliary forming sheet 21 has a higher absorption rate of the energy applied by the perforating means 6A than the base sheet 20 does. The energy absorptance can be measured, for example, by the following method.
<Method for measuring energy absorption rate>
When the sheet to be measured is irradiated with light of the same wavelength as that irradiated by the aperture means, the amount of energy incident on the sheet minus the energy reflected by the sheet and the energy transmitted by the sheet is absorbed. energy. The energy absorptance is obtained as the ratio of the energy absorbed by the sheet to the energy incident on the sheet. For example, if the incident energy is UV light, the absorptance is measured with a spectrophotometer or the like.

Next, in the manufacturing method of this embodiment, as shown in FIGS. 5 and 7A, a sheet lamination step is performed to form the lamination sheet 4 by laminating the base sheet 20 and the auxiliary molding sheet 21 . The sheet stacking process is performed in the sheet stacking section 40 . The sheet stacking section 40 has a pair of rolls 41 and 42 facing each other, as shown in FIG. In the manufacturing method of this embodiment, the laminated sheet 4 is formed by laminating the base sheet 20 and the auxiliary forming sheet 21 by inserting them between the pair of rolls 41 and 42 . In the sheet laminating step, the auxiliary forming sheet 21 may be laminated over the entire base sheet 20 or may be laminated over only a portion of the base sheet 20 .

Next, a projection forming step is performed. The projection forming step is performed in a projection forming portion 50 having a convex portion 51, as shown in FIG.
The convex portion 51 has a convex bottom portion 52 and a plurality of convex molds 53 projecting from the convex bottom portion 52 . That is, the convex portion 51 has a support (convex bottom portion 52) serving as a base and portions (convex portions 53) projecting from one surface of the support at a plurality of locations. The convex part 51 is not limited to such a form, and may have a structure consisting only of a projecting portion (convex part 53).

The convex shape 53 included in the convex shape part 51 corresponds to the shape of the internal space V of the hollow projection part 3 in the microneedle array 1 . An outer peripheral surface 54 (see FIG. 6) on the tip end side of the convex mold 53 has a shape along the inner surface 31b of the side wall 31 of the hollow protrusion 3 . The number and arrangement of the convex molds 53 of the convex part 51 correspond to the number and arrangement of the hollow protrusions 3 of the microneedle array 1 .

As the heating portion of the convex portion 51, various known ones can be used. In this embodiment, the heating unit is an ultrasonic vibration device including 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 ultrasonic vibration device is provided on the convex bottom portion 52 of the convex portion 51, and vibrates the convex portion 53 by vibrating the ultrasonic horn.

In the projection forming step, as shown in FIGS. 5 and 7B, a convex portion 51 having a heating portion is brought into contact with the laminated sheet 4 from the auxiliary forming sheet 21 side, and the convex portion of the laminated sheet 4 is formed. While softening the contact portion of the portion 51 by heat, the convex portion 51 is inserted into the laminated sheet 4 toward the base sheet 20 side. More specifically, the convex mold 53 of the convex part 51 is brought into contact with the laminated sheet 4 , and the convex mold 53 is attached to the laminated sheet 4 while softening the contact portion of the convex mold 53 in the laminated sheet 4 by heat. pierce.

Since the convex mold 53 heats the laminated sheet 4 in contact with the above-described ultrasonic vibration device, the contact portion is softened by heating and easily deformed. The softened portion of the laminated sheet 4 is stretched as the convex mold 53 is inserted, deforms along the outer surface of the convex mold 53, and the lamination projections 44 are formed. The laminated protrusions 44 have a structure in which the auxiliary forming sheet 21 is laminated on the inner surface side of the base sheet 20, and the portions of the laminated protrusions 44 made of the base sheet 20 are formed into hollow protrusions through subsequent steps. Part 3.

Next, a release process is performed. In the release step, as shown in FIG. 7(c), the convex portion 51 is pulled out from the laminated sheet 4. Then, as shown in FIG. More specifically, the convex mold 53 is pulled out from the inside of the stacking projection 44 . In this embodiment, the auxiliary forming sheet 21 is arranged along the inner surface of the hollow protrusion 3 formed by the release process.

Next, an opening forming step is performed. In the hole forming step, the hole 8 penetrating the side wall 31 of the hollow protrusion 3 is formed by the non-contact type hole forming means 6A. The aperture forming step is performed in an aperture forming section 60, as shown in FIG. As shown in FIG. 5 , the hole forming section 60 includes non-contact hole forming means 6A on the base sheet 20 side of the laminated sheet 4 . Examples of the non-contact perforating means 6A include processing devices using a heat source, such as a laser device that emits laser light, a hot air emission device that emits hot air, and a halogen lamp irradiation device that emits infrared rays. In the device 100, the laser device 6A is used from the viewpoint of being capable of condensing light and highly precise energy control necessary for microfabrication. As shown in FIG. 5, the laser device 6A has an irradiation head 61, which is a galvanometer scanner that freely scans the laser beam 6L. The irradiation head 61 is arranged on the side of the base sheet 20 in the laminated sheet 4 at a certain interval above the base sheet 20 in the thickness direction. In this way, when the non-penetrating hollow projections 3 are irradiated with the laser light 6L from the irradiation head 61 arranged on the base sheet 20 side of the laminated sheet 4 to form the openings 8 in the hollow projections 3, the hollow projections are formed. Burrs are less likely to be formed around the openings 8 on the outer surface 31 a of the portion 3 . In addition, since the opening 8 can be easily formed at an arbitrary position of the hollow protrusion 3, it is easy to arbitrarily control the position on the skin surface to which the liquid agent or the like is to be supplied.

As shown in FIG. 5, the irradiation head 61 has a lens 63 for condensing the irradiated laser light 6L, two mirrors 62 for freely scanning the condensed laser light 6L, and a protective lens 66. there is Although the protective lens 66 may or may not be provided, it is preferable to provide it in order to prevent dust from entering the optical system. A mirror 62 is attached to the motor shaft. The mirror 62 has a mechanism for moving the irradiation point of the laser beam 6L hitting the stack projections 44 on the laminate sheet 4 in the conveying direction Y of the base sheet 20, and a mechanism for moving it in the direction X perpendicular to the conveying direction of the laminate sheet 4. , so that the laser beam 6L can be scanned freely. The lens 63 is movable in the optical axis direction, and has a mechanism for condensing the laser beam 6L and making the spot diameter of the irradiation point of the laser beam 6L that strikes the stack protrusion 44 constant. in the thickness direction Z direction of the base sheet 20, and the like. An irradiation head 61 having a mirror 62 and a lens 63 can adjust the irradiation point of the laser beam 6L three-dimensionally in the X, Y and Z directions. Therefore, by three-dimensionally coordinating the positions to be irradiated on each of the nine stack projections 44, the laser beam 6L can be irradiated to the positions to be irradiated on each of the stack projections 44 with a predetermined spot diameter. As the laser beam 6L, it is preferable to use one that can be absorbed by the hollow protrusion 3 forming the aperture. When the base sheet 20 forming the hollow protrusions 3 is a sheet such as a film mainly made of thermoplastic resin, the laser light 6L may be a _CO2 laser, an excimer laser, an argon laser, a YAG laser, or an LD laser ( semiconductor laser), _YVO4 laser, fiber laser, etc. are preferably used.

In the opening forming step of this embodiment, as shown in FIG. 7D, the opening 8 is formed in the side wall 31 of the hollow protrusion 3 by irradiating the lamination protrusion 44 with the laser beam 6L. This point will be described in detail with reference to FIG. In this embodiment, as described above, the auxiliary forming sheet 21 has a higher energy absorption rate than the base sheet 20 . Therefore, when the lamination protrusions 44 are irradiated with the laser beam 6L from the base sheet 20 side as shown in FIG. As shown in (b), the auxiliary sheet 21 melts before the base sheet 20 melts. Then, as shown in FIG. 8C, the base sheet 20 is melted by the melting heat of the auxiliary molding sheet 21 . The heat of melting of the auxiliary forming sheet 21 is transmitted to the base sheet 20 through the contact portion between the auxiliary forming sheet 21 and the base sheet 20 . Therefore, the portion of the base sheet 20 near the melted portion of the forming assist sheet 21, that is, the portion of the base sheet 20 farther from the melted portion of the forming assist sheet 21 than the inner surface 31b of the side wall 31 of the base sheet 20, That is, the energy of the heat of fusion conducted is greater than that of the outer surface 31a of the side wall 31 of the base sheet 20 . Therefore, as shown in FIG. 8D, the inner surface 31b of the side wall 31 of the base sheet 20 is melted in a wider range than the outer surface 31a. As a result, one opening 8a located on the outer surface 31a of the side wall 31 has a smaller opening area than the other opening 8b located on the inner surface 31b.

Next, a separation step is performed. In the separation step, as shown in FIG. 7(g), the hollow protrusions 3 having the openings 8 formed therein are separated from the auxiliary forming sheet 21. Next, as shown in FIG. As a result, a continuous sheet having fine hollow projections 3 having openings 8 is obtained.
The production method of this embodiment may include a cutting step of cutting the obtained continuous sheet into a predetermined range after the separating step. In the cutting step, the continuous sheet is cut by a cutting device. Thereby, the microneedle array 1 is manufactured. The cutting device may be, for example, one that includes an anvil and a Thomson blade.

Thus, according to this embodiment, the area Sa of one opening 8a located on the outer surface 31a of the side wall 31 of the hollow protrusion 3 is larger than the area Sb of the other opening 8b located on the inner surface 31b of the side wall 31. Since a small microneedle array 1 can be manufactured, it is possible to provide hollow protrusions capable of pinpoint injection to a desired site.
Further, in this embodiment, since the opening forming step is performed after the releasing step, it is possible to prevent the convex portion 51 from being damaged by the opening means 6A when forming the opening 8 in the hollow projection portion 3. can.
In addition, in this embodiment, since the convex portion 51 is inserted into the lamination sheet 4 from the auxiliary forming sheet 21 side to form the lamination projection 44 , even after the convex portion 51 is pulled out from the lamination projection 44 , the hollow portion remains hollow. A forming auxiliary sheet 21 is arranged along the inner surface of the protrusion 3 . Therefore, even if a through-hole is formed in the lamination protrusion 44 after the convex part 51 has been pulled out by the opening means 6A, the shape of the hollow protrusion 3 can be easily maintained.
As described above, the manufacturing method of this embodiment can prevent the convex portion 51 from being damaged, and is excellent in moldability of the hollow projection portion 3 .

In this embodiment, the non-contact perforating means 6A is irradiation of laser light, burrs are less likely to be formed around the perforations 8, and the perforations 8 are formed at arbitrary positions of the hollow protrusions 3. It is also preferable from the viewpoint of ease of formation. From the viewpoint of achieving this effect more remarkably, it is preferable to use a material that has a higher absorptivity for laser light than the absorptance of the constituent material of the base sheet 20 as the constituent material of the auxiliary forming sheet 21 . .

In this embodiment, the means for heating the laminated sheet 4 in the projection forming step is not particularly limited, but it is preferable to heat the laminated sheet 4 by ultrasonically vibrating the convex portions 51 . By doing so, it is possible to change the amount of heat according to the extent to which the convex portion 51 is inserted. Become.

From the viewpoint of forming the hollow protrusions 3, the heating temperature of the laminated sheet 4 by heating the convex portion 51 is preferably higher than the glass transition temperature of the base sheet 20 or the auxiliary forming sheet 21 and lower than the melting temperature. In particular, it is preferably above the softening temperature and below the melting temperature. More specifically, it is preferable that the glass transition temperature or higher and lower than the melting temperature of the base sheet 20 and the glass transition temperature or higher and lower than the melting temperature of the molding auxiliary sheet 21. More preferably, the softening temperature of the auxiliary sheet 21 or higher and lower than its melting temperature.
More specifically, the heating temperature is preferably 30° C. or higher, more preferably 40° C. or higher, and preferably 300° C. or lower, more preferably 250° C. or lower. °C or higher and 300 °C or lower, more preferably 40 °C or higher and 250 °C or lower. In addition, when the laminated sheet 4 is heated using an ultrasonic vibration device, it is applied as the temperature range of the portion of the auxiliary forming sheet 21 that is in contact with the convex mold 53 . On the other hand, when the laminated sheet 4 is heated using a heater device instead of the ultrasonic vibration device, the heating temperature of the convex portion 51 may be adjusted within the above range. The glass transition temperature (Tg) is measured by the following method, and the softening temperature is measured according to JIS K-7196 "Softening temperature test method by thermomechanical analysis of thermoplastic films and sheets". .

[Method for measuring glass transition temperature (Tg)]
Calorimetry is performed using a DSC instrument to determine the glass transition temperature. Specifically, a differential scanning calorimeter (Diamond DSC) manufactured by Perkin Elmer is used as a measuring instrument. A test piece of 10 mg is taken from the base sheet. After maintaining the temperature at 20° C. for 5 minutes, the temperature was raised from 20° C. to 320° C. at a rate of 5° C./min to obtain a DSC curve of temperature on the horizontal axis and heat quantity on the vertical axis. Then, the glass transition temperature Tg is obtained from this DSC curve.

The "glass transition temperature (Tg) of the base sheet" means the glass transition temperature (Tg) of the constituent resin of the base sheet. When the temperatures (Tg) are different from each other, the heating temperature of the base sheet by the heating means is preferably at least the lowest glass transition temperature (Tg) of the plurality of glass transition temperatures (Tg). It is more preferable that the glass transition temperature (Tg) is the highest glass transition temperature (Tg) or higher. The same applies to the "glass transition temperature (Tg) of the auxiliary forming sheet".
Further, the "softening temperature of the base sheet" is the same as the glass transition temperature (Tg). The heating temperature of the base sheet by the heating means is preferably at least the lowest softening temperature or higher among the plurality of softening temperatures, and more preferably the highest softening temperature or higher among the plurality of softening temperatures. The same applies to the "softening temperature of the auxiliary molding sheet".
Further, when the base material sheet or the auxiliary molding sheet contains two or more resins having different melting points, the heating temperature of the laminated sheet 4 by the heating means is lower than the lowest melting point among the plurality of melting points. Preferably.

For example, when polylactic acid (PLA) is used as the thermoplastic resin contained in the base sheet 20, polyethylene terephthalate (PET), polycarbonate, polyetheretherketone, polyetheretherketone, polyetheretherketone, or polylactic acid (PLA) may be used as the constituent material of the auxiliary sheet 21. Etherimide, polystyrene, nylon resin, etc., may be mentioned, and among these, PET is preferable from the viewpoint of high recyclability because the auxiliary molding sheet 21 is not a final product.

From the viewpoint of facilitating separation of the auxiliary forming sheet 21 from the hollow protrusions 3 in the separating step, it is preferable to use a sheet that is not thermally welded to the base sheet 20 as the auxiliary forming sheet 21 . Materials that are not thermally welded to the base sheet 20 include, for example, polyethylene terephthalate (PET), polycarbonate, polystyrene, and nylon resin when polylactic acid (PLA) is used as the thermoplastic resin contained in the base sheet 20. etc.

In this embodiment, the thermoplastic resin contained in the auxiliary sheet 21 preferably has a melting point higher than that of the thermoplastic resin contained in the base sheet 20 . It is also preferable to use a thermoplastic resin that has a higher glass transition point than the thermoplastic resin that is contained in the base sheet 20 as the thermoplastic resin contained in the auxiliary molding sheet 21 . By setting the melting points or glass stain points of the thermoplastic resins contained in the auxiliary molding sheet 21 and the base sheet 20 to the relationship described above, if the hollow protrusions 3 are affected by the heat of fusion during the formation of the through-holes, Even if there is a possibility that the hollow protrusions 3 are likely to bend or bend, the shaped protrusions 33 can suppress the deformation of the hollow protrusions 3 .

If the insertion speed for inserting the convex portion 51 into the base sheet 20 is too slow, the resin will be excessively heated and softened, and if it is too fast, the heat softening will be insufficient. Therefore, it is preferably 0.1 mm/sec or more, more preferably 1 mm/sec or more, and preferably 1000 mm/sec or less, more preferably 800 mm/sec or less, specifically preferably 0 1 mm/sec or more and 1000 mm/sec or less, more preferably 1 mm/sec or more and 800 mm/sec or less.

From the viewpoint of efficiently forming the hollow projections 3, the insertion height of the convex portions 51 that pierce the base sheet 20 is preferably 0.01 mm or more, more preferably 0.02 mm or more. is 10 mm or less, more preferably 5 mm or less, specifically, preferably 0.01 mm or more and 10 mm or less, further preferably 0.02 mm or more and 5 mm or less. Here, the “insertion height” means the height between the vertex of the convex portion 53 and the upper surface 2U of the base sheet 20 in the laminated sheet 4 when the convex portion 53 of the convex portion 51 is inserted most into the laminated sheet 4 . means the distance between Therefore, the insertion height in the protrusion forming step is the height from the upper surface 2U of the base sheet 20 when the convex mold 53 is inserted most deeply in the protrusion forming step and the convex mold 53 protrudes from the upper surface 2U of the base sheet 20. It is the distance to the vertex of convex mold 53 measured in the vertical direction.

Regarding the ultrasonic vibration of the convex portion 51 by the ultrasonic vibration device, the frequency is preferably 10 kHz or more, more preferably 15 kHz or more, and preferably 50 kHz or less from the viewpoint of forming the hollow protrusion 3. , more preferably 40 kHz or less, specifically, preferably 10 kHz or more and 50 kHz or less, further preferably 15 kHz or more and 40 kHz or less. Regarding the ultrasonic vibration of the convex portion 51, the amplitude thereof is preferably 1 μm or more, more preferably 5 μm or more, and preferably 60 μm or less, more preferably 60 μm or less, from the viewpoint of forming the hollow projection portion 3. is 50 μm or less, specifically, preferably 1 μm or more and 60 μm or less, more preferably 5 μm or more and 50 μm or less.

The shape of the tip side of the convex portion 51 may be any shape as long as it corresponds to the outer shape of the hollow projection portion 3 of the hollow projection tool 1 to be manufactured. The height of the convex portion 53 of the convex portion 51 is formed to be the same as or slightly higher than the projection height H1 (see FIG. 3(a)) of the hollow projection portion 3 of the hollow projection tool 1 to be manufactured. 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, specifically, preferably 0.01 mm or more and 30 mm or less. and more preferably 0.02 mm or more and 20 mm or less. The tip diameter D1 (see FIG. 6) of the convex portion 51 of the convex portion 51 is preferably 0.001 mm or more, more preferably 0.005 mm or more, and preferably 1 mm or less, and more preferably It is 0.5 mm or less, specifically, preferably 0.001 mm or more and 1 mm or less, and more preferably 0.005 mm or more and 0.5 mm or less. The tip diameter D1 of the convex portion 53 of the convex portion 51 is measured as follows.
The convex portion 53 of the convex portion 51 has a base diameter D2 of preferably 0.1 mm or more, more preferably 0.2 mm or more, and preferably 5 mm or less, further 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 tip angle β of the convex portion 51 of the convex portion 51 is preferably 1 degree or more, more preferably 5 degrees or more, from the viewpoint of easily obtaining sufficient strength. The tip angle β is preferably 60 degrees or less, more preferably 45 degrees or less, and more preferably 1 degree or more and 60 degrees, from the viewpoint of obtaining a hollow projection 3 having an appropriate angle. or less, more preferably 5 degrees or more and 45 degrees or less. The tip angle β of the convex portion 51 is measured as follows.

[Measurement of Tip Diameter of Convex 53 of Convex Part 51]
The tip of the convex portion 53 of the convex portion 51 is observed with a scanning electron microscope (SEM) or a microscope magnified to a predetermined magnification. Next, as shown in FIG. 6, an imaginary straight line ILc is extended along the straight line portion of one side 11a of both sides 11a and 11b, and an imaginary straight line ILd is extended along the straight line portion of the other side 11b. Then, on the leading end side, a point where one side 11a separates from the imaginary straight line ILc is determined as a first point 11a1, and a point where the other side 11b separates from the imaginary line ILd is determined as a second point 11b1. The length D1 of the straight line connecting the first end point 11a1 and the second end point 11b1 obtained in this way is measured using a scanning electron microscope or a microscope, and the measured length of the straight line is The tip diameter of the die 53 is assumed to be the tip diameter.

[Measurement of Tip Angle β of Convex 53 of Convex Part 51]
The tip of the convex portion 53 of the convex portion 51 is observed, for example, as shown in FIG. 6 in a state of being magnified by a predetermined magnification using a scanning electron microscope or a microscope. Next, as shown in FIG. 6, an imaginary straight line ILc is extended along the straight line portion of one side 11a of both sides 11a and 11b, and an imaginary straight line ILd is extended along the straight line portion of the other side 11b. Then, the angle formed by the imaginary straight line ILc and the imaginary straight line ILd is measured using a scanning electron microscope or a microscope, and the measured angle is defined as the tip angle β of the convex portion 53 of the convex portion 51 .

The convex portion 51 is made of a high-strength material that is hard to break. Examples of the material of the convex portion 51 include metals such as steel, stainless steel, aluminum, aluminum alloys, nickel, nickel alloys, cobalt, cobalt alloys, copper, copper alloys, beryllium copper, and beryllium copper alloys, ceramics, and the like. .

In this embodiment, the opening 8 may be formed at the tip of the hollow protrusion 3, but from the viewpoint of the tip of the hollow protrusion 3 being less likely to be damaged and the skin to be easily punctured, the opening forming step is not performed. It is preferable to form the opening 8 by irradiating the laser beam 6L at a position shifted from the center of the tip of the penetrating hollow protrusion 3 . A viewpoint of forming the opening 8 by irradiating the side wall of the hollow protrusion 3 with the laser beam 6L with less irradiation energy, and a viewpoint of maintaining the strength around the formed opening 8 by suppressing the influence of the irradiation energy of the laser beam 6L. Therefore, in the aperture forming step, as shown in FIG. 7(d), the laser beam 6L is emitted from the irradiation head 61 of the laser device 6A in a direction ILf that is inclined with respect to the insertion direction ILe of the projection 53 of the projection 51. It is preferable to form the apertures 8 by irradiating the non-penetrating hollow protrusions 3 from the above. From the same point of view, the angle θ between the insertion direction ILe of the convex mold 53 and the inclined direction ILf in which the laser beam 6L is irradiated is preferably 5 degrees or more, more preferably 10 degrees or more. , is preferably 15 degrees or more, preferably 85 degrees or less, more preferably 80 degrees or less, and particularly preferably 75 degrees or less. Specifically, it is preferably 5 degrees or more and 85 degrees or less, more preferably 10 degrees or more and 80 degrees or less, and particularly preferably 15 degrees or more and 75 degrees or less. From the same point of view, the irradiation time of the laser beam 6L is preferably 0.001 ms or longer, more preferably 0.005 ms or longer, preferably 5 ms or shorter, and preferably 3 ms or shorter. More preferably, it is preferably 0.001 ms or more and 5 ms or less, and more preferably 0.005 ms or more and 3 ms or less. From the same point of view, the laser output of the laser beam 6L is preferably 0.5 W or more, more preferably 1 W or more, and preferably 100 W or less, and preferably 50 W or less. More preferably, specifically, it is preferably 0.5 W or more and 100 W or less, and more preferably 1 W or more and 50 W or less.

Although the present invention has been described above based on the preferred embodiments thereof, the present invention is not limited to the above embodiments and can be modified as appropriate.

For example, in the manufacturing method of the present embodiment, after the convex portions 51 are inserted into the laminated sheet 4 to form the laminated protrusions 44 , the cooling step of cooling the laminated protrusions 44 may be performed. The cooling step can be performed by blowing cold air onto the stacking protrusions 44 in a state in which the protrusions 53 of the protrusions 51 are inserted into the stacking protrusions 44, for example, using a cold air blower provided in the manufacturing apparatus 100. . It should be noted that when the heating means for the convex portion 51 is ultrasonic vibration as in the manufacturing apparatus 100, it is not always necessary to provide a cold air blower, and cooling can be performed by turning off the vibration of the ultrasonic vibration device. can also In this respect, it is preferable to use ultrasonic vibration as a heating means, because the device is simplified and the microneedle array 1 can be manufactured at high speed. In addition, heat is less likely to be transmitted to the portion of the laminated sheet 4 that is not in contact with the convex portion 51, and since cooling is efficiently performed by turning off the application of ultrasonic vibration, deformation other than the molded portion is less likely to occur. There is an advantage.

When the cooling process is performed, it is the time until the temperature rise of the convex part 51 in the heated state is stopped and the next cooling process is performed while the convex part 51 is inserted into the hollow projection part 3. If the softening time is too long, excessive heating will occur, but from the viewpoint of compensating for insufficient heating, it is preferably 0 seconds or longer, more preferably 0.1 seconds or longer, and preferably 10 seconds or shorter, and still more preferably. It is 5 seconds or less, specifically, preferably 0 seconds or more and 10 seconds or less, more preferably 0.1 seconds or more and 5 seconds or less.

In relation to the above-described embodiments, the present invention further discloses the following hollow projecting device and method for manufacturing the hollow projecting device.

EXAMPLES The present invention will be described in more detail below with reference to examples. However, the scope of the invention is not limited to such examples.

(1) Preparation of convex part 51 provided in manufacturing apparatus As the convex part 51, one having one conical convex part 53 was prepared. The convex mold 53 has a height (tapered portion height) H2 of 2.5 mm, a tip diameter D1 of 15 μm, a root diameter D2 of 0.5 mm, and a tip angle β of 11 degrees. Met.
(2) Preparation of piercing means 6A provided in manufacturing apparatus As the piercing means 6A, a UV laser device was used to irradiate UV laser light with a wavelength of 355 nm.

[Example 1]
The hollow projection device of Example 1 was manufactured in the order shown in FIGS. 7(a) to (g). As the base sheet 20, a sheet made of PLA and having a thickness of 0.4 mm was used. As the auxiliary forming sheet 21, a sheet made of PET and having a thickness of 0.4 mm was used. In the hole forming step, the position from the tip of the lamination protrusion 44 is 300 μm, the laser output of the laser beam 6L is 2 W, the irradiation time of the laser beam 6L is 2 milliseconds, and the insertion direction ILe and the inclined direction ILf are formed. The angle θ was set to 30 degrees.

[Comparative Example 1]
In the projection forming step, a PET sheet having a thickness of 0.4 mm was used as the base sheet 20 in the laminated sheet 4 . As the auxiliary forming sheet 21, a sheet made of PLA and having a thickness of 0.4 mm was used. That is, in the projection forming step of Comparative Example 1, the sheet used as the base sheet 20 and the sheet used as the auxiliary forming sheet 21 were reversed from those in Example 1. A hollow protrusion was manufactured in the same manner as in Example 1 except for these.

[Comparative Example 2]
In Example 1, a sheet made of PLA and having a thickness of 0.4 mm was used as the auxiliary forming sheet 21 . That is, in the sheet lamination step of Comparative Example 2, sheets having the same energy absorption rate were laminated. Also, in the hole forming process, the irradiation time of the laser beam 6L was changed to 20 milliseconds. In the separating step, the auxiliary forming sheet 21 located on the inner surface side of the projections formed in the projection forming step was separated from the base sheet 20 located on the outer surface side of the projections formed in the projection forming step.

The hollow protrusions of Example 1, Comparative Examples 1 and 2 were observed using a microscope to confirm the shape of the openings 8 formed in the sidewalls of the hollow protrusions. Table 1 schematically shows the results. In the enlarged cross-sectional view of the opening in Table 1, the left side of the cross-sectional view is the inner surface 31b side of the side wall 31, and the right side of the cross-sectional view is the outer surface 31a side of the side wall 31.

In addition, ease of separation in the separation step was evaluated according to the following criteria. These results are shown in Table 1.
(Evaluation criteria for ease of separation)
○: When the hollow protrusion and the auxiliary forming sheet can be separated in a state where there is no welding mark with the forming auxiliary sheet on the inner surface of the hollow protrusion. ×: The hollow protrusion and the forming auxiliary sheet can be separated, but they are separated. If there is a welding mark with the auxiliary molding sheet on the inner surface of the hollow projection that has been formed, or if the hollow projection and the auxiliary molding sheet cannot be separated

As shown in Table 1, in the hollow protrusion of Comparative Example 1, the through holes formed in the side wall of the hollow protrusion increased gradually from the inner surface 31b side of the side wall 31 toward the outer surface 31a side. That is, the area of the opening 8a positioned on the outer surface 31a side of the side wall 31 is larger than the area of the opening 8b positioned on the inner surface 31b of the side wall 31. As shown in FIG. Therefore, it can be seen that it is difficult for the hollow projection device of Comparative Example 1 to supply the agent to a desired location with pinpoint accuracy.

In the hollow projection device of Comparative Example 2, similarly to the hollow projection device of Comparative Example 1, the through holes formed in the side wall of the hollow projection device gradually increase from the inner surface 31b side of the side wall 31 toward the outer surface 31a side. Thus, the area of the opening 8a positioned on the outer surface 31a side of the side wall 31 was larger than the area of the opening 8b positioned on the inner surface 31b of the side wall 31 (see Table 1). Therefore, it can be seen that it is difficult for the hollow projection device of Comparative Example 2 to supply the agent to a desired location with pinpoint accuracy.
In Comparative Example 2, the evaluation result of ease of separation was "x". More specifically, the interface between the base material sheet 20 and the auxiliary forming sheet 21 is thermally fused, making it difficult to separate the sheets 20 and 21 from each other. In addition, it was confirmed that the inner surface of the peeled base sheet 20 had welding marks with the auxiliary forming sheet 21, and that the inner surface was rough (see the AA line cross-sectional view of Comparative Example 2 in Table 1). . In addition, it was confirmed that the outer surface of the peeled auxiliary forming sheet 21 had welding traces with the base sheet 20, and that the outer surface was rough (see the front view and left side view of Comparative Example 2 in Table 1). .

In the hollow protrusion of Example 1, as shown in Table 1, the opening 8 formed in the side wall 31 of the hollow protrusion 3 gradually decreased from the inner surface 31b side of the side wall 31 toward the outer surface 31a side. That is, the area of the opening 8a positioned on the outer surface 31a side of the side wall 31 is smaller than the area of the opening 8b positioned on the inner surface 31b of the side wall 31. As shown in FIG. Therefore, it can be seen that the hollow projection device of Example 1 can supply the agent to a desired location with pinpoint accuracy. In addition, as shown in Table 1, Example 1 was evaluated to be "O" for ease of separation, indicating that the hollow protrusion can be easily manufactured.

1 Microneedle array (hollow protrusion)
2 base portion 3 hollow protrusion portion 31 side wall 6A non-contact opening means 6L laser beam 7 opening portion 8 opening portion 20 base sheet 21 molding auxiliary sheet 51 convex portion 52 convex bottom portion 53 convex portion 100 manufacturing apparatus V internal space Y1 Transfer direction Z Height direction

Claims (9)

A method for manufacturing a hollow protrusion, comprising an aperture forming step of forming an aperture penetrating the side wall of a fine hollow protrusion by a non-contact piercing means,
a sheet laminating step of forming a laminated sheet by laminating a base sheet containing a thermoplastic resin and a molding auxiliary sheet having a higher absorption rate of energy applied by the perforating means than the base sheet;
A convex portion having a heating portion is brought into contact with the laminated sheet from the auxiliary forming sheet side, and while the contact portion of the convex portion in the laminated sheet is softened by heat, it is directed toward the base sheet side. a projection forming step of inserting the convex portion into the laminated sheet;
a release step of pulling out the convex portion from the laminated sheet;
the opening forming step performed after the releasing step;
A method for manufacturing a hollow protrusion, comprising a separation step of separating the hollow protrusion and the auxiliary forming sheet after the opening forming step. 2. The method of manufacturing a hollow protrusion according to claim 1, wherein the auxiliary sheet for forming is a sheet that is not thermally welded to the base sheet. 3. The method for manufacturing a hollow protrusion according to claim 1, wherein said non-contact type piercing means is irradiation of laser light. 4. The method of manufacturing a hollow protrusion according to claim 3, wherein a material having a higher absorptance for the laser light than the material for forming the base sheet is used as the material for forming the auxiliary sheet. The hollow protrusion according to any one of claims 1 to 4, wherein the thermoplastic resin contained in the auxiliary molding sheet has a melting point higher than that of the thermoplastic resin contained in the base sheet. method of making tools. 6. The thermoplastic resin contained in the molding auxiliary sheet having a glass transition point higher than that of the thermoplastic resin contained in the base sheet is used, according to any one of claims 1 to 5 A method for manufacturing the described hollow protrusion. 7. The method for manufacturing a hollow protrusion according to claim 1, wherein the laminated sheet is heated by ultrasonically vibrating the convex portion. A hollow projection tool having fine hollow projections with openings,
The aperture penetrates the side wall of the hollow protrusion,
A hollow protrusion, wherein the area of one opening located on the outer surface of the side wall is smaller than the area of the other opening located on the inner surface of the side wall. 9. The hollow projecting device according to claim 8, wherein the inner diameter of the opening gradually decreases from the inner surface side to the outer surface side of the side wall.

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