JP7394576B2 - fine protrusions - Google Patents

Description

TECHNICAL FIELD The present invention relates to a microprotrusion device having an opening.

In recent years, the delivery of drugs to the skin using microprotrusions equipped with microneedles has attracted attention because it does not damage the skin and causes less pain, although it can be expected to have the same performance as drug delivery using a syringe. As such fine protrusions, those described in, for example, Patent Documents 1 to 3 are known.

Patent Document 1 describes a microneedle device including a base material having grooves on the surface from which microneedles protrude, and a cover disposed on the surface of the base material. Further, Patent Document 2 describes a needle-like body including a protrusion provided on a substrate. Further, Patent Document 3 describes a microneedle assembly including microneedles having grooves on the surface and a support from which the microneedles protrude. The microneedle has an opening, and the opening communicates with the groove of the microneedle to form a channel for delivering a fluid drug compound.

Special Publication No. 2005-514179 Japanese Patent Application Publication No. 2008-228958 Special Publication No. 2014-519385

However, the fine protrusion tools of Patent Documents 1 and 2 do not have a housing part for accommodating the agent supplied by the microneedles, and apart from the fine protrusion tools, parts such as a syringe for holding the agent are required. is necessary. In addition, in order to discharge the agent from the openings of the microneedles during use, it takes time and effort to push out the agent from a syringe or the like. In the microneedle assembly disclosed in Patent Document 3, in order to discharge the drug compound from the microneedles, it is necessary to remove the release member that seals the opening of the support, which requires a laborious operation during use. be.

The present invention relates to a microprotrusion tool having apertures that can overcome the drawbacks of the prior art described above.

The present invention provides a microprotrusion device comprising a first sheet in which microprotrusions with openings are formed, a storage part for a drug to be injected into the skin, and a second sheet, wherein the storage part is arranged in the first sheet. The fine protrusions are formed between the sheet and the second sheet, and the fine protrusions provide fine protrusions that protrude on the opposite side of the first sheet from the accommodating portion side.

The present invention provides a container-filled microprotrusion tool that includes the above-described microprotrusion tool and a protective container that airtightly encloses the microprotrusion tool.

According to the microprojection device of the present invention, a drug can be injected into the skin with a simple operation.
According to the container-packed fine protrusion device of the present invention, it is possible to prevent the evaporation of the agent to be injected into the skin, which is accommodated in the accommodating portion of the fine protrusion device.

FIG. 1 is a cross-sectional view along the thickness direction of a fine protrusion according to a first preferred embodiment of the present invention. FIG. 2(a) is an enlarged sectional view of the main part showing the state before the fine hollow protrusion of the first embodiment is inserted into the skin, and FIG. 2(b) is an enlarged sectional view of the fine hollow protrusion of the first embodiment. FIG. 3 is an enlarged cross-sectional view of the main part showing the state after the skin is pricked. FIG. 3 is an explanatory diagram showing a method for measuring the tip diameter and tip angle of a microprotrusion. FIG. 4 is a diagram illustrating the method for manufacturing the fine protrusion tool of the first embodiment. FIG. 5 is a sectional view of a fine protrusion according to a second embodiment of the present invention, and is a view corresponding to FIG. FIG. 6 is a perspective view illustrating how to use the fine protrusion tool of the second embodiment. FIG. 7 is a diagram illustrating a method for manufacturing a fine protrusion according to the second embodiment. FIG. 8 is a sectional view of a fine protrusion according to a third embodiment of the present invention, and is a view corresponding to FIG. FIGS. 9(a) to 9(c) are cross-sectional views showing modified examples of the accommodating portion of the microprotrusion device of the present invention. FIG. 10 is a cross-sectional view showing a modification of the adhesive layer of the microprotrusion device of the present invention, and is a view corresponding to FIG. 1. FIG. 11(a) is a sectional view of a fine protrusion according to a fourth embodiment of the present invention, and is a view corresponding to FIG. FIG. 11(b) is a diagram showing a state in which the high-rigidity portion of the fine protrusion shown in FIG. 11(a) is pressed down. FIG. 12 is a sectional view showing the container-filled fine protrusion device of the present invention.

Hereinafter, the present invention will be described based on preferred embodiments thereof with reference to the drawings. FIG. 1 shows a cross-sectional view of a fine protrusion 1A according to a first preferred embodiment of the present invention. As shown in FIG. 1, the microprotrusion device 1A includes a first sheet 11, a storage section 4 for the agent 6 to be injected into the skin, and a second sheet 12. The storage portion 4 is formed between the first sheet 11 and the second sheet 12. A fine protrusion 2 having an opening 3 is formed in the first sheet 11, and the fine protrusion 2 protrudes on the opposite side of the first sheet 11 from the housing section 4 side.

In the fine protrusion tool 1A, as shown in FIG. 1, the fine protrusion 2 is provided in a portion of the first sheet 11 that overlaps with the accommodating portion 4. The first sheet 11 has a portion where the microprotrusions 2 are formed and a flat base portion 11a in which the microprotrusions 2 are not formed in a portion that overlaps with the storage portion 4, and the microprotrusions 2 are It protrudes from the lower surface of the base portion 11a.
The micro-protrusion tool 1A is equipped with a plurality of micro-protrusions 2, and when the micro-protrusion tool 1A is viewed from the first sheet 11 side, the protrusion rows in which the plurality of micro-protrusions 2 are arranged in series with an interval are mutually connected. One or more rows are formed with spaces between them. Regarding the arrangement of the microprotrusions 2, for example, the number of protrusion rows and the number of microprotrusions constituting the protrusion row can be set arbitrarily. The number of protrusion rows is, for example, 1 to 50 rows, more preferably 1 to 20 rows, even more preferably 2 to 10 rows, and the unit length of the microprotrusions constituting each protrusion row is 10 mm. The number of wires per wire is, for example, 3 or more and 30 or less, more preferably 3 or more and 20 or less, and still more preferably 3 or more and 10 or less. The positions of the protrusions may be shifted by half a pitch between adjacent protrusion rows.

Each microprotrusion 2 has a conical overall shape and has an opening 3 near its tip. The microprotrusions 2 are hollow inside, and the internal space of the microprotrusions 2 is defined by the area between the part of the first sheet 11 where the microprotrusions 2 are not present and the second sheet 12 on the proximal end side in the protrusion direction Z of the microprotrusions 2. It communicates with the space located therebetween and constitutes a part of the accommodating part 4. A part of the agent 6 to be injected into the skin may or may not enter the internal space of the microprojection 2 in the microprojection device 1A before use.

The fine protrusion 1A has an annular peripheral part 13 that annularly surrounds the accommodating part 4 around the accommodating part 4 in a plan view, and the first sheet 11 and the second sheet 12 are arranged in the annular peripheral part 13. It is joined. More specifically, the first sheet 11 and the second sheet 12 are joined at their respective peripheral edges located in the annular peripheral section 13 . On the other hand, the first sheet 11 and the second sheet 12 are not joined at the inner side of their peripheral edges, and there is a space between the first sheet 11 and the second sheet 12 for the agent 6 to be injected into the skin. A housing portion 4 is formed. The accommodating portion 4 in the fine protrusion tool 1A of this embodiment is a portion surrounded by the first sheet 11 and the second sheet 12 and sealed. Note that the first sheet 11 and the second sheet 12 may be joined together over the entire area of the annular peripheral part 13, or only a part of the width of the annular peripheral part 13, for example, a part near the accommodating part 4, is joined together. It may be joined over the circumference.

The second sheet 12 is disposed on the side opposite to the surface of the first sheet 11 from which the fine protrusions 2 protrude. Further, in the fine protrusion 1A, the second sheet 12 has a recessed portion 5 formed on the side opposite to the first sheet 11 side. The recess 5 has a trapezoidal cross-sectional shape along the thickness direction Z, and has a truncated cone shape as a whole. The upper surface 5a of the recess 5 is a flat surface, or a concave curved surface recessed toward the first sheet 11 side, from the viewpoint of making it easier to press the fine protrusion 1A from the second sheet 12 side with a finger or the like. It is preferable to have a concave curved surface depressed on the side opposite to the first sheet 11 side.

The first sheet 11 contains thermoplastic resin. The first sheet 11 is preferably made mainly of thermoplastic resin, that is, contains 50% by mass or more of thermoplastic resin, and more preferably contains 90% by mass or more of thermoplastic resin.
The second sheet 12 may be made of the same material as the first sheet 11 or may be made of a different material from the first sheet 11. The first sheet 11 and the second sheet 12 can be joined together by a simple joining method such as heat sealing, ultrasonic sealing, high frequency sealing, etc., and when forming the recess 5 in the second sheet 12, processing From the viewpoint of ease of use, the second sheet 12 also preferably contains a thermoplastic resin, and the second sheet 12 also preferably contains a thermoplastic resin of 50% by mass or more, and more preferably 90% by mass or more. .

Examples of the thermoplastic resin constituting one or both of the first sheet 11 and the second sheet 12 include polyfatty acid ester, polycarbonate, polypropylene, polyethylene, polyester, polyamide, polyamideimide, polyetheretherketone, polyetherimide, polystyrene, Examples include polyethylene terephthalates, polyvinyl chloride, nylon resins, acrylic resins, and combinations thereof, and biodegradable resins such as polyfatty acid esters are also preferably used. Examples of the polyfatty acid ester include polylactic acid, polyglycolic acid, and combinations thereof.

When the fine protrusions 1A are pressed from the second sheet 12 side, the second sheet 12 is more easily deformed than the first sheet 11, and the agent 6 stored in the storage section 4 is discharged from the opening 3. From the viewpoint of ease of use, it is preferable that the second sheet 12 is formed of a material that is more flexible than the first sheet 11.
Whether or not the second sheet 12 is made of a softer material than the first sheet 11 can be determined by the following method.
First, plate-shaped test specimens with the same thickness are created using the materials forming each of the first sheet 11 and the second sheet 12. Then, the durometer hardness of each of the created test specimens is measured by JIS K 7215:1986 plastic durometer hardness test. Compare the measurement results, and if the test piece made using the material forming the second sheet is softer than the test piece made using the material forming the first sheet, the second sheet 12 It is determined that the first sheet 11 is made of a softer material than the first sheet 11 .

The first sheet 11 preferably has a Rockwell hardness of about M94-101 as measured according to JIS K 7202-2: 2001 Plastics - How to determine hardness - Part 2. The second sheet 12 preferably has a durometer hardness of approximately A20 as measured by a JIS K 7215:1986 plastic durometer hardness test.

The accommodating portion 4 of the microprotrusion device 1A is a portion in which an agent to be injected into the skin is accommodated.
The agent 6 to be injected into the skin is not particularly limited as long as it can be injected into the skin using the microprotrusion device of the present invention, such as (1) a liquid agent containing an active ingredient for improving the skin condition; (2) Examples include drugs including vaccines used to prevent infectious diseases. The above (1) includes a beauty serum, cosmetic fluid, or medicinal solution that is an aqueous solution or emulsion and contains one or more selected from collagen, hyaluronic acid, vitamin C, amino acids, royal jelly, salicylic acid, etc. as an active ingredient. Examples of (2) include drugs containing BCG vaccine, rubella vaccine, and influenza vaccine as active ingredients. The skin is typically human skin, but may also be the skin of a pet such as a dog or cat, or the skin of a domestic animal such as a cow, pig, or goat. It may also be the skin of animals other than mammals, such as the skin of snakes, frogs, and silkworms.

According to the fine protrusion device 1A, with the agent 6 to be injected into the skin stored in the storage part 4, the first sheet 11 side on which the fine protrusions 2 are formed is placed on the person to whom the agent 6 is to be injected. By pressing the fine protrusions 2 against the skin, the fine protrusions 2 can be pierced into the skin. Then, when the fine protrusion device 1A is pressed with a finger or the like from the second sheet 12 side while the fine protrusion 2 is stuck into the skin, the volume of the storage part 4 decreases, and the agent 6 stored in the storage part 4 decreases. is pushed out through the apertures 3 of the microprotrusions 2 and injected into the skin.

According to the microprotrusion tool 1A, the agent can be applied to the skin at a desired site by the simple operation of pressing the side on which the microprotrusions 2 are formed and pressing the second sheet side as necessary. can be injected.

As shown in FIG. 1, the fine projection tool 1A has a flat shape as a whole, and the direction in which the first sheet 11 and the second sheet 12 face each other or the direction in which the fine projections 2 protrude is defined as the thickness direction Z. In some cases, the thickness T of the fine protrusion 1A is preferably 100% or less, preferably 70% or less, and more preferably 50% or less of the maximum dimension W in the direction perpendicular to the thickness direction Z.
If the fine protrusion device 1 has a flat shape as a whole, the state in which the fine protrusion device 1A is pressed against the skin becomes stable, and the injection operation of the agent by pressing the second sheet 12 side becomes easier. can be done. In addition, the thickness T of the micro protrusion 1A is determined by the maximum dimension W in the direction perpendicular to the thickness direction Z, from the viewpoint of securing the volume inside the accommodating portion 4 and the amount of change in the internal volume due to the pressure on the second sheet 12 side. , preferably 5% or more and 50% or less, more preferably 10% or more and 40% or less, and still more preferably 25% or more and 30% or less.
The fine protrusion tool 1A shown in FIGS. 1 and 5 has a circular shape in a plan view, and the maximum dimension W in the direction perpendicular to the thickness direction Z is the diameter of the circular outline in a plan view.

The fine protrusion device of the present invention, like the fine protrusion device 1A, is capable of extruding the agent to be injected into the skin through the openings of the fine protrusions by pressing the second sheet side, thereby completing the injection in a short time. However, it is not essential to press the second sheet side to deform it during use. After pressing the microprotrusion device against the skin to pierce the skin, it is fixed on the skin with an adhesive section provided on the bottom side where the microprotrusions protrude, or with a separately prepared net bandage or adhesive tape, and then accommodated by heating. The agent 6 may be injected into the skin without pressing from the second sheet side due to an increase in internal pressure or the action of gravity.

As described above, in the fine protrusion 1A, the first sheet 11 and the second sheet 12 are joined to each other in the annular peripheral part 13 surrounding the housing part 4, and the first sheet 11 and the second sheet 12 defined by the housing part 4 are One or both of the second sheets 12 have a recess 5 . Therefore, it is also possible to provide the recesses 5 in both the first sheet 11 and the second sheet 12 so that a larger amount of medicine can be held in the storage section 4.

As shown in FIG. 2, human skin has an epidermis S on the outermost side, a dermis R on the inner side of the epidermis S, and a subcutaneous tissue Q on the inner side of the dermis R. Further, the epidermis S has a stratum corneum S1 located at the outermost side and a lower layer portion S2 of the epidermis located inside the stratum corneum. However, FIG. 2 is exaggerated for ease of explanation, and does not necessarily accurately represent the thickness of each layer in the actual skin. The lower layer S2 of the epidermis is composed of the granular layer, the spinous layer, the basal layer, and the like.
With the microprotrusion device of the present invention, the part of the skin where the agent 6 is injected may be the epidermis S, the dermis R, or the subcutaneous tissue Q near the dermis R. However, the preferred part of the skin where the agent is injected is cosmetics, etc. For non-medical purposes, it is the epidermis S, more preferably the stratum corneum S1. Therefore, in the microprojection device of the present invention, it is preferable that the epidermis S is the main injection site for the agent. On the other hand, from the viewpoint of limiting the height of microprojections, it is preferable not to use the dermis as the main injection site for the agent.

In addition, in the microprotrusion tool 1A, the microprotrusion 2 has a conical shape, but other than the conical shape, it may have a truncated conical shape, a cylindrical shape, a prismatic shape, a pyramidal shape, a truncated pyramid shape, etc. You can. Further, in the microprotrusion tool 1A, the microprotrusion 2 has a conical shape as a whole, but only the tip portion may be cone-shaped and the midsection and root portion may be cylindrical or the like.
Since at least the tip of the microprotrusion 2 has a conical shape, there is an effect that the microprotrusion easily sticks into the skin.

When the fine protrusions 1A are pressed from the second sheet 12 side and the fine protrusions 2 are pierced into the skin, one or both of the periphery of the fine protrusions 1A and the tips of the fine protrusions 2 are punctured by the fine protrusions 2. In order to push down the skin along with its surroundings, only the tips of the microprojections 2, not the entire microprojections 2, pierce the epidermis S of the skin (see FIG. 2). From the viewpoint of allowing the tip of the microprotrusion 2 to penetrate into the stratum corneum S1 of the epidermis S, the protrusion height H2 is preferably 100 μm or more, more preferably 150 μm or more, and still more preferably 200 μm or more. It is. In addition, from the viewpoint of preventing the microprotrusions 2 from penetrating the stratum corneum S1 and their tips from penetrating the lower layer S2 of the epidermis, the protrusion height H2 of the microprotrusions 2 is preferably 300 μm or less, more preferably It is 250 μm or less, more preferably 230 μm or less. From the viewpoint of ensuring that the main site where the agent 6 is injected is the stratum corneum S1 of the skin, the protrusion height H2 of the microprotrusions 2 is preferably 100 μm or more and 300 μm or less, more preferably 150 μm or more and 250 μm or less, and even more preferably It is 200 μm or more and 230 μm or less.

In addition, from the viewpoint of making it easier to inject the agent 6 discharged from the aperture 3 into the stratum corneum S1 when the microprotrusion 2 is inserted into the epidermis S of the skin, the aperture 3 is located at the center of the microprotrusion 2 in the protruding direction. It is preferable that the position is within 20 μm from the tip of the microprotrusion 2 . Further, it is preferable that the apertures 3 exist on the outer surface of the microprotrusions 2 from the viewpoint of maintaining the apertures when the microprotrusions are inserted into the skin. That is, it is preferable that the distance H3 from the tip of the microprotrusion 2 to the center position of the opening 3 is 20 μm or less [see FIG. 2(a)]. From the same viewpoint, the distance H3 is more preferably 15 μm or less, more preferably 7 μm or more, more preferably 10 μm or more, and preferably 7 μm or more and 20 μm or less, more preferably 10 μm or more and 15 μm or less. Here, the central position of the aperture 3 in the protrusion direction of the microprotrusion 2 is a position that divides the space between the distal end 3a and the proximal end 3b of the aperture 3 into two in the protrusion direction. It is. Further, the distal end 3a of the aperture 3 refers to the tip of the microprotrusion 2 among both ends of the opening in the aperture 3 that opens to the outer surface of the microprotrusion 2 in the protrusion direction of the microprotrusion 2. The proximal end 3b of the aperture 3 refers to the ends of the aperture 3 that open to the outer surface of the microprotrusion 2 in the protruding direction of the microprotrusion 2. This is the end of the microprotrusion 2 that is closer to the tip. The diameter of the opening 3 is 20 μm or more and 80 μm or less, more preferably 40 μm or more and 50 μm or less. The diameter of the second opening is also preferably 20 μm or more and 80 μm or less, more preferably 40 μm or more and 50 μm or less.

The number of fine protrusions 2 is not particularly limited, but from the viewpoint that the larger the number of fine protrusions, the more widely the drug can be injected into the skin, the number per 10 mm square is preferably 2 or more, more preferably 2 or more. The number is preferably 5 or more, more preferably 10 or more, and preferably 50 or less, more preferably 20 or less, even more preferably 15 or less, and specifically, preferably 2 or more and 50. The number is less than 1, more preferably 5 or more and 20 or less, and even more preferably 10 or more and 15 or less.

When the microprotrusion tool 1A has a plurality of microprotrusions 2, the distance between the centers of the microprotrusions 2 is preferably 1.5 mm or more, more preferably 2.0 mm or more, and still more preferably 3.0 mm or more. Yes, and preferably 10.0 mm or less, more preferably 5.0 mm or less, still more preferably 4.0 mm or less, and specifically, preferably 1.5 mm or more and 10.0 mm or less, more preferably It is 2.0 mm or more and 5.0 mm or less, more preferably 3.0 mm or more and 4.0 mm or less.

The diameter L of the tip of the microprotrusion 2 (the distance between the outer walls 21, 21 at the tip, see FIG. 3) is preferably 1.0 μm or more, more preferably 5.0 μm or more, and still more preferably 10.0 μm or more. and preferably 20.0 μm or less, more preferably 15.0 μm or less, even more preferably 12.0 μm or less, and preferably 1.0 μm or more and 20.0 μm or less, and more preferably 5.0 μm or more and 15.0 μm or less. It is 0 μm or less, more preferably 10.0 μm or more and 12.0 μm or less.
The tip diameter L of the microprotrusion 2 is the length at the widest position at the tip of the microprotrusion 2 . When the diameter L of the tip of the microprotrusion 2 is within the above range, there is almost no pain when the microprotrusion 2 is inserted into the skin. The tip diameter L of the microprotrusion 2 is measured as follows.

[Measurement of the tip diameter L of the fine protrusion 2 of the fine protrusion tool 1A]
The tips of the microprotrusions 2 are observed using a scanning electron microscope (SEM) or a microscope at a predetermined magnification as shown in FIG. Next, as shown in FIG. 3, an imaginary straight line ILa is assumed along a straight line part on one side 1a of both sides 1a and 1b forming the outer wall 21, and a virtual straight line ILa is assumed along a straight line part on the other side 1b. Assume a virtual straight line ILb. Next, on the tip side, a point where one side 1a departs from the virtual straight line ILa is determined as a first tip point 1a1, and a point where the other side 1b departs from the virtual straight line ILb is determined as a second tip point 1b1. The length L of the straight line connecting the first tip point 1a1 and the second tip point 1b1 obtained in this way is measured using a scanning electron microscope (SEM) or a microscope, and the measured length of the straight line is Let be the tip diameter of the microprotrusion 2.

The tip angle α (see FIG. 3) of the fine protrusion 2 is preferably set from the viewpoint that the more acute the tip, the easier it is to puncture the skin, and the more obtuse the tip, the easier it is to process the tip. is 10 degrees or more, more preferably 15 degrees or more, even more preferably 20 degrees or more, and preferably 50 degrees or less, more preferably 40 degrees or less, even more preferably 30 degrees or less, and preferably 10 degrees or more. The angle is 50 degrees or less, more preferably 15 degrees or more and 40 degrees or less, and even more preferably 20 degrees or more and 30 degrees or less. The tip angle α of the microprotrusion 2 is measured as follows.

[Measurement of the tip angle α of the fine protrusion 2 of the fine protrusion tool 1A]
The tips of the microprotrusions 2 are observed using a scanning electron microscope (SEM) or a microscope, magnified to a predetermined magnification as shown in FIG. Next, as shown in FIG. 3, an imaginary straight line ILa is assumed along a straight line part on one side 1a of both sides 1a and 1b forming the outer wall 21, and an imaginary straight line ILa is assumed along a straight line part on the other side 1b. Assume a straight line ILb. Then, the angle formed by the virtual straight line ILa and the virtual straight line ILb is measured using a scanning electron microscope (SEM), and the measured angle is defined as the tip angle α of the microprotrusion 2.

An example of a method for manufacturing the fine protrusion 1A of the first embodiment will be described with reference to FIG. 4.
As shown in FIG. 4, first, a belt-shaped first sheet 11 containing a thermoplastic resin is unwound from the original fabric roll 11A and conveyed. Next, the convex portion 30 having the convex portion 31 corresponding to the minute protrusion 2 is brought into contact with one surface (lower surface) side of the first sheet 11 . Then, while softening the contact portion of the first sheet 11 with the convex portion 31 by heat, the convex portion 31 is stabbed into the first sheet 11, and the non-penetrating portion protruding from the other surface (upper surface) of the first sheet 11 is The fine protrusions 2 are formed. At this time, in order to prevent the first sheet 11 from bending when the convex portion 31 is inserted from one side, the first sheet 11 may be supported by support members 32u and 32d, as shown in FIG. Then, with the protrusions 31 still stuck in the first sheet 11 or with the protrusions 31 removed from the first sheet 11, a laser beam is irradiated from the laser irradiation device 33 to form the holes 3 in the minute protrusions 2. form. In this way, the first sheet 11 in which the fine protrusions 2 having the openings 3 are formed is manufactured.

Separately from the step of manufacturing the first sheet 11, a step of manufacturing the second sheet 12 having the recessed portions 5 is performed. Specifically, as shown in FIG. 4, a band-shaped second sheet 12 containing a thermoplastic resin is unwound from the original fabric roll 12A and conveyed. Then, the second sheet 12 is heated and depressed using, for example, a heat press device 40 to form the concave portions 5. In this way, the second sheet 12 having the recesses 5 is obtained. Next, the agent 6 to be injected into the skin, which is supplied from the tank 41, is dispensed into the individual recesses 5 formed in the second sheet 12.

Then, the second sheet 12 is placed on the side of the first sheet 11 opposite to the side on which the fine protrusions 2 are provided, with the depressions of the recesses 5 facing the side opposite to the first sheet 11 side. and form a fine protrusion precursor 10A. Next, the anvil 42d is brought into contact with the second sheet 12 side of the fine protrusion precursor 10A, and the impulse sealer 42u is brought into contact with the first sheet 11 side of the fine protrusion precursor 10A, thereby sealing the first sheet 11 and the first sheet 11. The peripheral edges of the two sheets 12 are fused together by heat. Then, by cutting the peripheral edges of the first sheet 11 and the second sheet 12 fused together using the anvil 43d and the Thomson blade 43u, the fine protrusion tool 1A is manufactured.

Next, a second embodiment of the microprotrusion tool of the present invention will be described with reference to FIG. Regarding the fine protrusion tool 1B according to the second embodiment, the differences from the fine protrusion tool 1A according to the first embodiment will be explained. Points that are not particularly explained are the same as the fine protrusion tool 1A according to the first embodiment, and the description of the fine protrusion tool 1A applies as appropriate.

The fine protrusion tool 1B has an adhesive layer 7 at a portion of the second sheet 12 that overlaps with the storage portion 4, and the adhesive layer 7 is provided on the surface of the second sheet 12 opposite to the first sheet side. There is. More specifically, an adhesive is fixed to the upper surface 5a of the recess 5 of the second sheet 12 to provide the adhesive layer 7. The surface of the adhesive layer 7 opposite to the surface on the second sheet 12 side is covered with a protective layer 8 that is releasably fixed to the adhesive layer 7 . The protective layer 8 covers the adhesive layer 7 until it is intentionally peeled off when the adhesive layer 7 is used, and prevents the adhesive strength of the adhesive layer 7 from decreasing due to adhesion of dust or dirt, contact with other objects, etc. . Examples of the protective layer 8 include a release paper whose surface on the adhesive layer side is coated with silicone, a resin sheet whose surface on the adhesive layer side is subjected to a release treatment, and the like. The protective layer 8 is peeled off manually when the adhesive layer 7 is used.

Examples of the adhesive constituting the adhesive layer 7 include emulsion-based, water-based, and solvent-based adhesives. Further, from the viewpoint of simplifying the process of forming the adhesive layer 7, it is preferable to form the adhesive layer 7 by applying an adhesive such as a hot melt adhesive.
The adhesive layer 7 may be formed by applying an adhesive directly to the second sheet 12, or may be formed by pressing and transferring the adhesive applied to the protective layer 8 onto the second sheet 12. good. Alternatively, the one side of an adhesive sheet having an agent layer on one side and an adhesive layer on the other side may be attached to the second sheet 12, and the adhesive layer on the other side may be used as the adhesive layer 7.
As the adhesive, it is preferable to use a synthetic rubber-based block copolymer having a basic structure similar to natural rubber from the viewpoint of stability of adhesive force over time. Examples of such block copolymers include styrene-isoprene-styrene block copolymer (SIS), styrene-ethylene-propylene-styrene copolymer (SEPS), and styrene-butadiene-styrene block copolymer (SBS). , styrene-ethylene-butylene-styrene copolymer (SEBS), and the like. The adhesive preferably contains 10 to 65% by weight, particularly 30 to 50% by weight of one or more base polymers selected from these block copolymers.

The basis weight of the adhesive in the adhesive layer 7 is determined as shown in FIG. From the viewpoint of making it easier to arrange in the location, it is preferably 1 g/m ² or more, more preferably 5 g/m ² or more, and preferably 100 g/m ² or less, and more preferably 50 g/m ² or less. and preferably 1 g/m ² or more and 100 g/m ² or less, more preferably 5 g/m ² or more and 50 g/m ² or less.

Further, the holding sheet 9 is impregnated with an agent 6 to be injected into the skin and accommodated in the accommodating portion 4 of the microprotrusion device 1B. The holding sheet 9 is a sheet impregnated with the agent 6 to be injected into the skin. As the holding sheet 9, any sheet material that can be impregnated with the agent 6 to be injected into the skin can be used, such as a nonwoven fabric made by various methods such as a highly liquid-absorbing nonwoven fabric, a sheet made of a porous material such as a sponge, or a sheet made of a porous material such as pulp. etc. can be used. From the viewpoint that the higher the liquid absorbency, the more drugs can be retained, it is preferable to use a highly liquid absorbent nonwoven fabric as the holding sheet 9.

For example, as shown in FIG. 6, the fine protrusion tool 1B can be made by peeling off the protective layer 8 from the adhesive layer 7 to expose the adhesive layer 7, and then attaching the adhesive layer 7 to a finger or the like. can be easily placed at the desired site where the agent 6 is to be injected into the skin. Further, after placing the fine protrusions 1B on a desired part with the fine protrusions 1B attached to the fingertips etc. via the adhesive layer 7, the second sheet 12 side is placed with the fine protrusions 1B attached to the fingertips etc. It is also possible to inject the agent by pressing and collect the microprojection device 1B from the skin.
From the viewpoint of simplifying the injection work of the agent using the micro-projection tool, the micro-projection tool of the present invention can be attached to a finger or the like via the adhesive layer 7 and placed at a desired site. It is preferable that the adhesive layer 7 be attached to a finger, etc., and it is more preferable that it can be placed in a desired area and injected. More preferably, it is possible to place it at a desired site, inject it, and recover it from the skin while it is attached.
The object to which the fine protrusions 1B is attached via the adhesive layer 7 is preferably a human finger, but it may be other than a human finger, for example, the fine protrusions 1B are placed in an area that is out of reach. It may also be a rod-shaped body for pressing, a dedicated pressing device equipped with a pressure sensor that can detect the pressure during pressing, or the like.

In addition, in the fine protrusion device 1B and the fine protrusion device 1C described later, the holding sheet 9 is impregnated with the agent 6 to be injected into the skin and is stored in the storage section 4, so the second sheet 12 is held with a finger or the like. The medicine will not come out from the opening unless it is pressed, and it is possible to prevent the medicine from being inadvertently discharged.

As shown in FIG. 7, the fine protrusion tool 1B of the second embodiment is manufactured by manufacturing a second sheet 12 in which a laminated sheet 70 is adhered to the concave portion 5 as the second sheet 12. After placing the holding sheet 9 in the recess 5, the first embodiment described above is performed, except that the agent 6 to be injected into the skin, which is supplied from the tank 41 (see FIG. 4), is supplied to the holding sheet 9 in each recess 5. It can be manufactured in the same manner as the example of the manufacturing method of the micro-protrusion tool 1A of the above-mentioned configuration.
To explain the process shown in FIG. 7, the band-shaped second sheet 12 is unrolled from the raw fabric roll 12A, introduced into the heat press device 40, and heated in the heat press device 40, and partially depressed. Then, the recess 5 is formed in the second sheet 12. Further, a strip-shaped laminated sheet 70 having a structure in which the adhesive layer 7 and the protective layer 8 are laminated is unrolled from the raw roll, and the laminated sheet 70 is placed in a second sheet with the adhesive layer 7 side facing the second sheet 12 side. It is attached to a portion of the second sheet 12 corresponding to the upper surface 5a of the recessed portion 5. Then, while the anvil 51u is in contact with the opposite side of the upper surface 5a of the recess 5, the cutter blade 51d is brought into contact with the upper surface 5a side of the recess 5 to cut the strip-shaped laminated sheet 70, and cut the laminated sheet 70 into individual pieces. The laminated sheet 70 has a shape to be provided on the fine protrusion 1B.

Further, the belt-shaped holding sheet 9 is unwound from the original fabric roll 9A and introduced into a cutting device 61 equipped with an anvil roll 61u and a cutter roll 61d. Then, the belt-shaped holding sheet 9 is cut into sheets of holding sheet 9 by the cutter roll 61d. The cutter roll 61d preferably has a suction and suction stop mechanism for the holding sheet 9 on the outer peripheral surface of the roll. As the suction and suction stop mechanism, for example, the internal space of the cutter roll 61d that does not rotate is divided into a depressurized section and a non-depressurized section, and a through hole is provided in the outer periphery of the roll that rotates around the internal space. functions as a suction hole for drawing air from the outside into the interior while passing over the evacuated compartment; while passing over the non-evacuated compartment, such a suction hole Examples include mechanisms that are configured so that they do not function as such. By using the cutter roll 61d equipped with a holding sheet suction and suction stop mechanism, the cut holding sheet 9 can be conveyed to the position corresponding to the recess 5 while being held on the surface of the cutter roll 61d. Suction can be stopped at a position corresponding to the recess 5 and the holding sheet 9 can be accommodated in the recess 5.
In this way, the second sheet 12 to which the laminated sheet 70 is attached is manufactured, and after the holding sheet 9 is accommodated in the recess 5 of the second sheet 12, the agent 6 to be injected into the skin is placed on the holding sheet 9. It is supplied and impregnated into the holding sheet 9. The fine protrusion tool 1B of the second embodiment can be manufactured by performing subsequent steps similar to the manufacturing method described above in the first embodiment.

Next, a third embodiment of the microprotrusion tool of the present invention will be described with reference to FIG. 8. Regarding the fine protrusion tool 1C according to the third embodiment, the differences from the fine protrusion tool 1B according to the second embodiment will be explained. Points that are not particularly described are the same as the fine protrusion tool 1B according to the second embodiment, and the description of the fine protrusion tool 1B applies as appropriate.

As shown in FIG. 8, the fine protrusion 1C has the fine protrusion 1C attached to the annular peripheral portion 13 located outward from the portion overlapping with the accommodation portion 4 on the first sheet 11 side surface of the fine protrusion 1C. , has an adhesive part 72 for fixing to the skin. In the fine protrusion tool 1C, the adhesive part 72 is formed of an adhesive disposed on the side of the second sheet 12 opposite to the first sheet 11 side so as to extend from the outer peripheral edge of the second sheet 12. has been done.
More specifically, as shown in FIG. 8, with respect to the second sheet 12, an adhesive sheet 71 having an adhesive layer 7a on one side of a base sheet 7b covers the entire upper surface 5a side of the second sheet 12. The adhesive layer 7a is attached so as to have a portion extending from the outer peripheral edge of the second sheet 12, and the adhesive layer 7a in the portion extending from the outer peripheral edge of the second sheet 12 forms the adhesive portion 72. Further, on the surface of the adhesive layer 7a extending from the peripheral edge of the second sheet 12 on the side opposite to the base sheet 7b side, a protective layer 8 having the same structure as the protective layer 8 of the micro protrusion 1B is provided. It is arranged.
According to the fine protrusion tool 1C, when in use, the protective layer 8 is peeled off to expose the adhesive part 72 made of the adhesive layer 7a in the portion extending from the peripheral edge of the second sheet 12, so that the adhesive part 72 can be removed. The fine protrusion device 1C can be attached to the skin of a desired site such as the face, arm, or chest. The adhesive layer 7a can be made of an adhesive similarly to the adhesive layer 7 related to the microprotrusion tool 1B.

If the microprotrusion tool 1C has an adhesive part 72 for fixing the agent 6 to the skin to be injected on the lower surface side from which the microprojection 2 protrudes, the microprotrusion tool 1C placed at a desired site can be Unintentional displacement from the relevant part is prevented. Further, after temporarily fixing to an arbitrary part via the adhesive part 72, if the position is not appropriate, it can be peeled off and fixed again to an appropriate part. In this way, when the fine protrusion device has the adhesive part 72 for fixing it to the skin to which the agent 6 is injected, it becomes easy to fix the fine protrusion device to an appropriate site, so that the agent 6 can be injected easily. It is easy to inject into the skin at the appropriate intended site. Moreover, if the microprotrusion device has the adhesive part 72 for fixing it to the skin to which the agent 6 is injected, the microprotrusion device can be attached without using another fixing material such as a net bandage or adhesive tape. This makes it possible to maintain the state in which the microprotrusions 2 are pierced into the skin, and for example, it is possible to easily inject the agent 6 into the skin gradually over time.

It is preferable that the adhesive portion 72 for fixing to the skin is provided in the annular peripheral portion 13 outward from the portion overlapping with the housing portion 4, as in the case of the microprotrusion device 1C. By providing the adhesive part 72 in the annular peripheral part 13 that does not overlap with the housing part 4, the effect of easily fixing the microprotrusion tool to an appropriate part can be achieved more reliably, and it can also be done over a long period of time. The effect is that a minute amount of the drug can be injected into the skin.

Next, a fourth embodiment of the microprotrusion tool of the present invention will be described with reference to FIG. 11. Regarding the fine protrusion tool 1D according to the fourth embodiment, differences from the fine protrusion tool 1A according to the first embodiment will be explained. Points that are not particularly explained are the same as the fine protrusion tool 1A according to the first embodiment, and the description of the fine protrusion tool 1A applies as appropriate.

As shown in FIG. 11, the fine protrusion tool 1D has a high-rigidity portion 16 formed in a portion on the second sheet 12 side that faces the region of the first sheet 11 where the fine protrusions 2 are formed. The high-rigidity portion 16 is a portion having a durometer hardness of A60 or more. The durometer hardness of the high-rigidity portion 16 is preferably A70 or more, more preferably A80 or more. Durometer hardness can be measured by the durometer hardness test described above. The high-rigidity region 16 may be formed in the entire region of the second sheet 12 side that faces the region of the first sheet 11 where the fine protrusions 2 are formed, or it may be formed in a part of the region. However, it is preferable that it be formed over the entire area.

The high-rigidity region 16 may be formed by increasing the rigidity of a region of the second sheet 12 that faces the region where the microprotrusions 2 of the first sheet 11 are formed, or It may be formed by disposing a member separate from the sheet in a portion of the second sheet that faces the area in which the fine protrusions 2 of the first sheet 11 are formed.

As a method for increasing the rigidity of the region of the second sheet 12 that faces the region of the first sheet 11 in which the fine protrusions 2 are formed, for example, applying heat to the region of the second sheet 12, For example, the thickness of this portion of the second sheet 12 may be made thicker than other portions.

When a member separate from the second sheet is disposed in a portion of the second sheet that faces the area where the fine protrusions 2 of the first sheet 11 are formed, the number of separate members is one. or more than one. The durometer hardness of the entire portion of the second sheet 12 where the separate member is arranged may be A60 or more, and the durometer hardness of the separate member itself may be less than A60. Examples of the material constituting the separate member include thermoplastic resin, thermosetting resin, and metal.

The fine protrusion tool 1D has the high-rigidity portion 16, so that when the high-rigidity portion 16 is pushed down, the agent 6 can be pushed out while the high-rigidity portion 16 maintains the same shape without being deformed. Therefore, the agent 6 can be pushed out in an amount corresponding to the amount by which the high-rigidity portion 16 is pushed down.

As shown in FIG. 11, in the fine protrusion tool 1D, when the high-rigidity part 16 is pushed down, the spacer member 15 that comes into contact with the outer peripheral part 16a of the high-rigidity part 16 and restricts further depression is the first Preferably, it is arranged between the sheet and the second sheet. The spacer member 15 is an annular member. The spacer member 15 may be continuous or discontinuous in the circumferential direction. Although the shape of the spacer member 15 in plan view is not particularly limited, it is preferably similar to the shape of the accommodating portion 4 in plan view.

The thickness t of the spacer member 15 is preferably 0.5 mm or more, more preferably 1.0 mm or more, from the viewpoint of maintaining the rigidity that allows the spacer member 15 to maintain its shape. From the viewpoint of facilitating the quantitative release of the agent 6 when discharging the agent 6, it is preferably 2 mm or less, more preferably 1.5 mm or less, and from the viewpoint of achieving both, preferably 0.5 mm or more. It is 2 mm or less, more preferably 1 mm or more and 1.5 mm or less (see FIG. 11).

The outer diameter D of the spacer member 15 is such that it is easy to quantitatively release the agent 6 in the storage portion 4 when discharging the agent 6 with respect to the maximum dimension W in the direction perpendicular to the thickness direction Z of the micro-projection tool 1D. From the viewpoint of this, it is preferably 50% or more, more preferably 60% or more, from the viewpoint of making the width of the annular peripheral part 13 wide and preventing poor bonding between the first sheet 11 and the second sheet 12. , preferably 80% or less, more preferably 70% or less, and from the viewpoint of achieving both, preferably 50% or more and 80% or less, and more preferably 60% or more and 70% or less (Figure 11 reference).

The inner diameter d of the spacer member 15 is larger than the maximum dimension W in the direction perpendicular to the thickness direction Z of the fine protrusion tool 1D. It is preferably 20% or more, more preferably 30% or more, from the viewpoint of being able to maintain the inner diameter d, and preferably 40% or less, and more It is preferably 35% or less, and from the viewpoint of achieving both of these, it is preferably 20% or more and 40% or less, and more preferably 30% or more and 35% or less (see FIG. 11).

Since the fine protrusion tool 1D has the spacer member 15, the amount of depression P when the high-rigidity portion 16 is pushed down can be made constant. Therefore, the discharge amount of the agent 6 from the fine projection tool 1D can be made constant. Furthermore, for example, when the fine protrusion device 1D is pressed against the skin of a human subject to whom the agent 6 is to be injected and the highly rigid region 16 is pushed down, the skin may become depressed or tilted due to the pushing down force. be. In this way, even if the surface against which the fine protrusion tool 1D is pressed is unstable, by having the spacer member 15, when the high-rigidity region 16 is pushed down, the peripheral edge of the high-rigidity region 16 Since the portion 16a contacts the spacer member 15, a certain amount of the agent 6 can be stably discharged.

The fine protrusion tool 1D of the fourth embodiment has the following steps except for forming the high-rigidity portion 16 on the second sheet 12 and disposing the spacer member 15 between the first sheet 11 and the second sheet 12. , it can be manufactured in the same manner as the example of the manufacturing method of the fine protrusion tool 1A of the first embodiment described above.

In the step of forming the high-rigidity region 16 on the second sheet 12, for example, by applying heat to a region of the second sheet 12 that faces the region where the fine protrusions 2 of the first sheet 11 are formed, the high-rigidity region 16 is formed. Alternatively, the high-rigidity region 16 may be formed by making the region of the second sheet 12 that faces the region of the first sheet 11 in which the fine protrusions 2 are formed thicker than other regions. Alternatively, by disposing a member separate from the second sheet in a portion of the second sheet that faces the area where the fine protrusions 2 of the first sheet 11 are formed, a highly rigid region can be formed. 16 may be formed.

The step of disposing the spacer member 15 between the first sheet 11 and the second sheet 12 is preferably performed before the first sheet 11 and the second sheet 12 are fused together. When manufacturing the fine protrusion tool 1D of the fourth embodiment, it is preferable to form the recess 5 in the second sheet 12 and then arrange the spacer member 15 in the recess 5.

Next, the container-filled fine protrusion device of the present invention will be explained. FIG. 12 shows a container-filled fine projection device 10, which is a preferred embodiment of the container-filled fine projection device of the present invention. The container-filled fine protrusion 10 includes a fine protrusion 1A and a protective container 18 that airtightly encloses the fine protrusion 1A. In the container-filled fine protrusion 10, the part of the fine protrusion 1A on the second sheet 12 side is releasably adhered to the protective container 18, so that the tip of the fine protrusion 2 does not come into contact with the inner surface of the protective container 18. It has become.

The protective container 18 has a container body 18a and a lid portion 18b. The container body 18a has a protrusion accommodating portion 19 in which the fine protrusion 1A is accommodated. The container body 18a and the lid part 18b are fixed to each other at their peripheral edges so that they can be removed by hand. By fixing the container body 18a and the lid part 18b, the protrusion housing part 19 is hermetically sealed. The surface of the lid portion 18b on the fine protrusion tool 1A side includes a portion of the fine protrusion tool 1A on the second sheet 12 side, more specifically, the surface of the second sheet 12 on the opposite side from the first sheet 11 side. However, it is removably bonded with an adhesive or the like. When the fine protrusion tool 1A is peeled off from the lid part 18b, the adhesive may remain on either the lid part 18b side or the part of the fine protrusion tool 1A on the second sheet 12 side. From the viewpoint of enabling the agent to be used as the adhesive layer 7, it is preferable that the agent remains on the second sheet 12 side of the fine protrusion 1A. In the container-filled fine projection device 10 of this embodiment, as shown in FIG. It is removably adhered via an adhesive layer 7.

In the container-filled fine protrusion device 10, the fine protrusion device 1A is hermetically enclosed in the protective container 18, so that the agent 6 accommodated in the accommodating portion of the fine protrusion device 1A can be prevented from evaporating. In addition, in the container-filled microprotrusion tool 10, the tip of the microprotrusion 2 of the microprotrusion tool 1A does not come into contact with the inner surface of the protective container 18. This can prevent the tips of the fine protrusions 2 from being crushed due to contact.

The inner diameter of the protrusion accommodating portion 19 of the container body 18a is preferably greater than or equal to the maximum dimension W in the direction perpendicular to the thickness direction Z of the fine protrusion 1A. Further, it is preferable that the depth of the protrusion accommodating portion 19 is equal to or greater than the thickness T of the fine protrusion 1A.

Examples of materials constituting the container body 18a and the lid portion 18b include synthetic resins such as thermoplastic resins, synthetic resins such as thermosetting resins, and metals. The material constituting the container body 18a and the material constituting the lid portion 18b may be the same or different. Moreover, the container main body 18a and the lid part 18b may be separate bodies or may be formed integrally.

Although the present invention has been described based on its preferred embodiments, the present invention is not limited to the above-described embodiments and can be modified as appropriate. For example, in the fine protrusion tool 1A of the first embodiment, the recess 5 has a trapezoidal cross-sectional shape, and has a truncated cone shape as a whole. As shown, it may have a stepped portion 5b projecting in a stepwise manner.
When the recess 5 has a step 5b, when dispensing the agent 6 to be injected into the skin into the recess 5, the height position of the step 5b and the amount of agent injected up to the step 5b are determined. It can be used as a reference for controlling the amount of injection into each recess 5. For example, by dispensing the amount of the agent 6 up to the height of the stepped portion 5b, the agent 6 enters between the first sheet 11 and the second sheet 12 at the peripheral edges of the first sheet 11 and the second sheet 12. Therefore, it is possible to prevent a bonding failure between the first sheet 11 and the second sheet 12 from occurring. Further, the shape of the recessed portion 5 may be other shapes than a truncated cone shape, such as a truncated pyramid shape.

Furthermore, in the fine protrusions 1A to 1D of the first to fourth embodiments, the recess 5 is formed by recessing the second sheet 12 on the side opposite to the first sheet 11, but the recess 5 is As shown in b), the first sheet 11 may be formed to be depressed toward the second sheet 12 side. Furthermore, the recess 5 may be formed in both the first sheet 11 and the second sheet 12, as shown in FIG. 9(c). Specifically, the second sheet 12 is recessed on the side opposite to the first sheet 11 side, and the recess 5 is formed in the second sheet 12, and the first sheet 11 is recessed on the second sheet 12 side. , a recess 5 may be formed in the first sheet 11. The accommodating portion 4 may have only one of the recess 5 formed in the first sheet 11 and the recess 5 formed in the second sheet 12, or may have both. Further, the agent impregnated in the holding sheet 9 may be stored in the storage portion 4 shown in FIGS. 9(a) to 9(c).

Furthermore, there are no particular restrictions on the arrangement of the microprotrusions 2 and the shape of the microprotrusions 2. For example, in the microprotrusions 1A to 1D of the first to fourth embodiments, the microprotrusions 2 are arranged in an array (single or multiple rows), but in addition to the array, a plurality of microprotrusions 2 are arranged. Any arrangement may be used, such as an arrangement in which they are arranged in an arbitrary shape such as a circle or a star shape.

Further, in the microprotrusion tools 1A to 1D of the first to fourth embodiments, the opening 3 is located at the tip of the microprotrusion 2, but in addition to the tip, the opening 3 is located at the midsection or root of the microprotrusion 2. It may be located. Furthermore, there is no particular restriction on the number of openings 3 that one microprotrusion 2 has, and one microprotrusion 2 may have a plurality of openings 3. Furthermore, when the microprotrusion device of the present invention is provided with a plurality of microprotrusions 2, it is sufficient that at least one of the plurality of microprotrusions 2 has an opening 3; 2 may be provided. The number of apertures 3 that the microprotrusion device of the present invention has and the number of microprotrusions 2 that the microprotrusion device of the present invention has may be the same or different.

Further, second apertures different from the apertures 3 of the microprotrusions 2 may be provided in the portions of the first sheet 11 where the microprotrusions 2 do not protrude. By providing the second openings in the portions of the first sheet 11 where the fine protrusions 2 do not protrude, the agent 6 to be injected into the skin can be applied not only to the inside of the skin but also to the surface of the skin. becomes possible. It is preferable that the second openings be provided in a region that overlaps with the accommodation portion 4, and when viewed from the first sheet 11 side, the second openings may be formed within a projection area surrounding all the microprotrusions, or may be formed in an area outside of the protrusion area where is formed.

In addition, in the fine projection tool 1A of the first embodiment, the adhesive sheet 71 is arranged so as to cover the entire second sheet 12, and has a portion extending from the peripheral edge of the second sheet 12. However, the adhesive part 72 provided on the lower surface side from which the microprotrusions 2 protrude, preferably the adhesive part 72 provided in the annular peripheral part 13 located outward from the part overlapping with the accommodation part 4, is like the adhesive part 72 shown in FIG. , an adhesive may be applied to the peripheral edge of the first sheet 11. In the embodiment shown in FIG. 10, an adhesive is disposed on the peripheral edge of the first sheet 11 on the lower surface side from which the microprotrusions 2 of the first sheet 11 protrude, forming an adhesive part 72. 72 is covered and protected with a protective layer 8 having the same structure as the protective layer 8 in the third embodiment. The fine protrusion shown in FIG. 10 also provides the same effects as the fine protrusion of the third embodiment.

The use of the microprotrusion device of the present invention is not limited to non-medical purposes such as cosmetics, but may also be used as a medical device. When the microprotrusion device of the present invention is expected to be effective as a medical device, the region of the skin where the agent 6 is injected is preferably the dermis R or the subcutaneous tissue Q near the dermis R (see FIG. 2).

When using the microprotrusion device of the present invention as a medical device, the protrusion height H2 of the microprotrusion 2 is preferably 500 μm or more, more preferably It is 1000 μm or more. In addition, from the viewpoint of preventing the microprotrusions 2 from penetrating the dermis R and preventing their tips from penetrating the subcutaneous tissue Q to a large extent, the protrusion height H2 of the microprotrusions 2 is preferably 2500 μm or less, more preferably 2000 μm or less. be. Moreover, from the viewpoint of injecting liquid into the dermis R, the protrusion height H2 of the microprotrusions 2 is preferably 500 μm or more and 2500 μm or less, more preferably 1000 μm or more and 2000 μm or less.

When using the microprotrusion device of the present invention as a medical device, the distance H3 from the tip of the microprotrusion 2 to the central position of the aperture 3 is determined from the viewpoint that the tip of the microprotrusion 2 penetrates the epidermis S and reaches the dermis R. , preferably 200 μm or more, more preferably 300 μm or more. Further, the distance H3 is preferably 800 μm or less, more preferably 500 μm or less, from the viewpoint of ensuring the strength of the tip portion of the microprotrusion 2. Further, the distance H3 is preferably 200 μm or more and 800 μm from the viewpoint that the tip of the microprotrusion 2 must penetrate the epidermis S and reach the dermis R, and it is necessary to ensure the strength of the tip of the microprotrusion 2. or less, more preferably 300 μm or more and 500 μm or less.

The present invention further discloses the following additional notes (fine protrusions).
<1>
A microprotrusion device comprising a first sheet in which microprotrusions with openings are formed, a container for a drug to be injected into the skin, and a second sheet,
The storage portion is formed between a first sheet and a second sheet,
The fine protrusion is a fine protrusion tool, in which the fine protrusion protrudes on a side opposite to the accommodating portion side of the first sheet.
<2>
The microprotrusion device according to <1> above, wherein the microprotrusion is hollow inside.
<3>
The space inside the microprotrusion communicates with the space located between the second sheet and the portion of the first sheet where the microprotrusion does not exist on the proximal end side in the protruding direction of the microprotrusion, so that the space inside the microprotrusion communicates with the space located between the second sheet and the portion of the first sheet where the microprotrusion does not exist. The fine protrusion tool according to <2> above, which constitutes a part of.
<4>
The protrusion height of the microprotrusions is preferably 100 μm or more, more preferably 150 μm or more, even more preferably 200 μm or more, and preferably 300 μm or less, more preferably 250 μm or less, and even more preferably 230 μm or less. The fine protrusion tool according to any one of <1> to <3> above.
<5>
The fine projection device according to any one of <1> to <4>, wherein the agent to be injected into the skin can be pushed out from the openings by pressing the second sheet side.

<6>
The first sheet and the second sheet are joined to each other at an annular peripheral portion located outward from a portion overlapping with the storage portion,
The accommodating portion is either a recess formed by recessing the first sheet on the side opposite to the second sheet side or a recess formed by recessing the second sheet on the side opposite to the first sheet side. or both.
<7>
The first sheet and the second sheet are the fine protrusions according to <6>, wherein a part of the width of the annular peripheral portion is joined over the entire circumference.
<8>
The fine protrusion tool according to any one of <1> to <7>, which has an adhesive layer on a surface of the second sheet opposite to the first sheet side, at a portion overlapping with the accommodating portion.

<9>
<1> to <8>, wherein an adhesive part for fixing the fine protrusion to the skin is provided in an annular peripheral part located outward from a part overlapping with the accommodation part on the first sheet side surface; ＞The fine protrusion tool according to any one of ＞.
<10>
The adhesive portion is formed of an adhesive disposed on the side of the second sheet opposite to the first sheet side so as to extend from the outer peripheral edge of the second sheet, <9> above. The fine protrusion tool described in .
<11>
The microprotrusion device according to <9>, wherein the adhesive portion is formed of an adhesive disposed on the peripheral edge of the first sheet on the lower surface side from which the microprotrusions of the first sheet protrude.
<12>
The adhesive part is adapted to temporarily fix the fine protrusion to an arbitrary part, and then peel off the fine protrusion and fix it again to an appropriate part, <1> to <1>. 11>.

<13>
The fine protrusion device according to any one of <1> to <12>, wherein the agent to be injected into the skin is impregnated into a holding sheet and accommodated in the accommodating portion.
<14>
The microprotrusion tool according to any one of <1> to <13>, wherein the tip of the microprotrusion has a conical shape.
<15>
The microprotrusion device according to any one of <1> to <14>, wherein the opening is located within 20 μm from the tip of the microprotrusion.
<16>
The microprotrusion device according to any one of <1> to <15>, wherein a second opening is formed in a portion of the first sheet that overlaps with the accommodation portion and where the microprotrusion does not exist. .
<17>
The microprotrusion tool according to <16> above, wherein the second opening has a diameter of preferably 20 μm or more and 80 μm or less, more preferably 40 μm or more and 50 μm or less.
<18>
The microprotrusion tool according to any one of <1> to <17>, wherein the second sheet is more flexible than the first sheet.
<19>
It has an overall flat shape,
When the thickness direction is the direction in which the first sheet and the second sheet face each other or the direction in which the fine protrusions protrude, the thickness of the fine protrusions is preferably relative to the maximum dimension in the direction perpendicular to the thickness direction. is 100% or less, preferably 70% or less, more preferably 50% or less, the fine protrusion according to any one of <1> to <18>.

<20>
<1> to <19> above, wherein a high-rigidity region having a durometer hardness of A60 or more is formed in a portion of the first sheet on the second sheet side opposite to the region where the microprotrusions are formed. The fine protrusion according to any one of the above.
<21>
The microprotrusion according to <20>, wherein the high-rigidity region is formed by increasing the rigidity of a region of the second sheet that faces the region in which the microprotrusion is formed on the first sheet. Ingredients.
<22>
The high-rigidity portion is formed by disposing a member separate from the second sheet in a portion of the second sheet that faces the region in which the fine protrusions of the first sheet are formed. The fine protrusion tool according to <20> above.
<23>
A spacer member is disposed between the first sheet and the second sheet, and the outer circumference of the high-rigidity portion comes into contact with the high-rigidity portion when the high-rigidity portion is pressed down to restrict further pressing down. 20> to the fine protrusion tool according to any one of the above <22>.
<24>
A container-filled fine protrusion tool, comprising the fine protrusion tool according to any one of <1> to <23> above, and a protective container that airtightly encloses the fine protrusion tool.
<25>
<24> above, wherein a portion of the fine protrusion is releasably adhered to the protective container on the second sheet side, so that the tip of the fine protrusion does not come into contact with the inner surface of the protective container. Fine protrusions in a container described in .

1A, 1B, 1C, 1D Microprotrusion device 11 First sheet 12 Second sheet 13 Annular peripheral part 2 Microprotrusion 3 Opening 4 Accommodation part 5 Recessed part 6 Agent to be injected into the skin 7 Adhesive layer 8 Protective layer 9 Holding sheet 70 Lamination Sheet 71 Adhesive sheet 7b Base sheet 7a Adhesive layer 72 Adhesive part (adhesive part for fixing the agent to the skin to be injected)
10 Micro-protrusion device in container 18 Protective container S Epidermis S1 Horny layer S2 Lower part of epidermis R Dermis Q Subcutaneous tissue

Claims (14)

A microprotrusion device comprising a first sheet in which microprotrusions with openings are formed, a container for a drug to be injected into the skin, and a second sheet,
The storage portion is formed between a first sheet and a second sheet,
The fine protrusions protrude on a side opposite to the accommodating part side of the first sheet ,
A microprotrusion tool, wherein a high-rigidity portion having a durometer hardness of A60 or more is formed in a portion of the first sheet on the second sheet side that faces the area where the microprotrusions are formed . The microprojection device according to claim 1, wherein the agent to be injected into the skin can be pushed out from the openings by pressing the second sheet side. The first sheet and the second sheet are joined to each other at an annular peripheral portion located outward from a portion overlapping with the storage portion,
The accommodating portion is either a recess formed by recessing the first sheet on the side opposite to the second sheet side or a recess formed by recessing the second sheet on the side opposite to the first sheet side. The fine protrusion tool according to claim 1 or 2, which has at least one of the following. The fine projection device according to any one of claims 1 to 3, further comprising an adhesive layer on a surface of the second sheet opposite to the first sheet at a portion overlapping with the accommodating portion. Any one of claims 1 to 4, wherein an adhesive part for fixing the microprotrusion device to the skin is provided in an annular peripheral part located outward from a part overlapping with the accommodation part on the first sheet side surface. The fine protrusions described in section. According to claim 5, the adhesive portion is formed of an adhesive disposed on the side of the second sheet opposite to the first sheet so as to extend from the outer peripheral edge of the second sheet. The detailed protrusion tool described. 6. The microprotrusion tool according to claim 5, wherein the adhesive portion is formed of an adhesive disposed on the peripheral edge of the first sheet on the lower surface side of the first sheet from which the microprotrusions protrude. The microprotrusion device according to any one of claims 1 to 7, wherein the agent to be injected into the skin is impregnated into a holding sheet and accommodated in the accommodating portion. The microprotrusion tool according to any one of claims 1 to 8, wherein the tip of the microprotrusion has a conical shape. The microprotrusion tool according to any one of claims 1 to 9, wherein the center of the opening in the protrusion direction of the microprotrusion is located within 20 μm from the tip of the microprotrusion. The microprojection device according to any one of claims 1 to 10, wherein second openings are formed in a portion of the first sheet that overlaps with the accommodating portion and where the microprojections are not present. The microprotrusion device according to any one of claims 1 to 11, wherein the second sheet is more flexible than the first sheet. A spacer member is disposed between the first sheet and the second sheet, and the outer circumferential portion of the high-rigidity portion comes into contact with the high-rigidity portion when the high-rigidity portion is pressed down to restrict further pressing down. The fine projection device according to any one of items 1 to 12 . A container-filled fine protrusion device, comprising the fine protrusion device according to any one of claims 1 to 13 , and a protective container that airtightly encloses the fine protrusion device.

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