JP2019176980A - Microneedle - Google Patents

Abstract

To provide a microneedle that can give good use feelings.SOLUTION: A microneedle includes a substrate having a first surface and a second surface, and a protrusion formed on the first surface of the substrate. Sound is generated when the substrate is pressed from the second surface to the first surface with force of predetermined magnitude or more. The substrate is curved in a recessed shape from the first surface to the second surface. When the substrate is pressed from the second surface to the first surface with force of predetermined magnitude or more, the substrate may change so as to be curved in a recessed shape from the second surface to the first surface and sound may be generated.SELECTED DRAWING: Figure 1

Description

  The present invention relates to a microneedle used for medical treatment, a MEMS (Micro Electro Mechanical Systems) device, an optical member, drug discovery, cosmetics, cosmetic use, and the like. The present invention relates to a microneedle that punctures skin.

  The drug can be administered to the human body by oral administration, puncture of the skin dermis layer or vein with a syringe, application to the local dermis layer by applying an ointment to the skin surface, local dermis layer by applying to the skin surface And the like (see Patent Document 1).

  Among these, as a device for administering a drug into the body by a method of sticking or puncturing using an applicator, in recent years, development of a microneedle having protrusions that are a plurality of minute needles has been advanced. As the material of the microneedle, a material that is harmless even if dissolved or remains in the living body is selected so that even if a part of the needle-shaped body is broken by puncture and remains in the body, it is harmless.

International Publication No. 2005/058162 JP 2006-334419 A

  The microneedle punctures the skin with a fine needle. For this reason, there is a problem that the feeling of use is poor for the user. An object of this invention is to provide the microneedle with a usability | use_condition.

  As one aspect of the invention for solving the above-mentioned problem, a microneedle including a substrate having a first surface and a second surface, and a protrusion formed on the first surface of the substrate, the substrate When the needle is pressed from the second surface toward the first surface with a force greater than or equal to a predetermined value, the microneedle generates sound.

  Further, when the substrate is concavely curved from the first surface toward the second surface and the substrate is pressed from the second surface toward the first surface with a force of a predetermined magnitude or larger, the second It may change so that it may curve concavely from the surface toward the first surface, and sound may be generated.

  In addition, the second surface of the substrate is connected to a plate-like support member, and the support member is concavely curved from the connection surface with the substrate toward the opposite surface of the connection surface, and the support member is opposite to the connection surface. When pressing from the surface toward the connection surface, the sound may change so as to bend in a concave shape from the opposite surface of the connection surface toward the connection surface.

  In addition, the second surface of the substrate is connected to the structure, and the structure has a cavity sealed inside, and the structure has a force of a predetermined magnitude or more toward the second surface. When the pressure is pressed, sound may be generated by destroying the wall surface forming the sealed cavity of the structure.

  In addition, the first surface of the substrate is connected to the structure, and the structure has a cavity sealed inside, and the structure is pressed by the first surface with a force larger than a predetermined level. In this case, sound may be generated by breaking the wall surface forming the sealed cavity of the structure.

  ADVANTAGE OF THE INVENTION According to this invention, the microneedle with a usability | use_condition can be provided.

The perspective view of the microneedle which concerns on the 1st Embodiment of this invention Use explanatory drawing of the microneedle which concerns on the 1st Embodiment of this invention The perspective view of the microneedle which concerns on the 2nd Embodiment of this invention. Use explanatory drawing of the microneedle which concerns on the 2nd Embodiment of this invention The perspective view of the microneedle which concerns on the 3rd Embodiment of this invention. Use explanatory drawing of the microneedle which concerns on the 3rd Embodiment of this invention The perspective view of the microneedle which concerns on the 4th Embodiment of this invention Use explanatory drawing of the microneedle which concerns on the 4th Embodiment of this invention The perspective view of the microneedle which concerns on the 5th Embodiment of this invention Use explanatory drawing of the microneedle which concerns on the 5th Embodiment of this invention

  Hereinafter, the microneedle of the present invention will be described. The microneedle of the present invention is typically used for puncturing the skin, and includes a substrate having a first surface and a second surface, and a protrusion formed on the first surface of the substrate. A microneedle, wherein a sound is generated when a substrate is pressed from a second surface toward a first surface. In addition, the microneedle of this invention is not limited to embodiment shown below.

[First Embodiment]
FIG. 1 shows a perspective view of the microneedle 1 according to the first embodiment of the present invention. The microneedle 1 includes a substrate 11 having a first surface 11A and a second surface 11B, and a protrusion 12 formed on the first surface 11A. There may be one protrusion 12 or a plurality of protrusions 12. And the board | substrate 11 is curving concavely toward the 2nd surface 11B from the 1st surface 11A in the state before use.

  FIG. 2 is a diagram illustrating how the microneedle 1 is used. In use, the microneedle 1 is first disposed so that the protrusion 12 faces the skin S (FIG. 2A, FIG. 2B). When the second surface 11B of the substrate is pressed by the finger F toward the skin S with a force of a predetermined magnitude or more, the substrate 11 is concavely curved from the first surface 11A toward the second surface 11B. The projection changes on the first surface 11A of the substrate 11 from the second surface 11B to the first surface 11A, which changes (reverses) to a concavely curved state (hereinafter also referred to as a convex shape). The part 12 is punctured into the skin ((C) of FIG. 2). When the microneedle 1 presses the second surface 11B of the substrate 11, the substrate 11 is inverted from a concave shape to a convex shape when the load exceeds a predetermined value. When the substrate 11 is inverted, the substrate 11 is inverted, and for example, a sound such as “click” is generated. Thereby, the user can obtain a feeling of use of the microneedle 1. Moreover, since the substrate 11 is inverted from the concave shape to the convex shape when the load exceeds a predetermined value, the microneedle 1 can set the puncture load when the protrusion 12 is punctured to the skin as the predetermined load. The puncture of the protrusion 12 into the skin can be controlled.

  In the present invention, the “sound” of “sound is generated” is a frequency within a range of 5 Hz to 20000 Hz that can be felt by humans, and may be within a range of 5 decibels to 80 decibels.

[Second Embodiment]
FIG. 3 shows a perspective view of the microneedle 2 according to the second embodiment of the present invention. The microneedle 2 includes a substrate 11 having a first surface 11A and a second surface 11B, a protrusion 12 formed on the first surface 11A, and a plate-like support member 13. There may be one protrusion 12 or a plurality of protrusions 12. The second surface 11B of the substrate 11 is connected to the support member 13. In a state before use, the support member 13 is curved in a concave shape from the surface to which the substrate 11 is connected toward the opposite surface of the connected surface.

  FIG. 4 is a diagram illustrating how the microneedle 2 is used. In use, the microneedle 2 is first disposed so that the protrusion 12 faces the skin S (FIGS. 4A and 4B). Then, when the support member 13 is pressed toward the skin S with the finger F with a force of a predetermined magnitude or more, the support member 13 becomes concave from the surface to which the substrate 11 is connected toward the opposite surface to the connected surface. It changes (inverts) from a curved state to a concavely curved state (convex shape) from the opposite surface of the surface to which the substrate 11 is connected to the connected surface, and at the same time, changes to the first surface 11A of the substrate 11. A certain protrusion 12 is punctured into the skin ((C) of FIG. 4). When the microneedle 2 presses the support member 13, the support member 13 is inverted from a concave shape to a convex shape when the load exceeds a predetermined value. When the support member 13 is reversed, the support member 13 is reversed, and for example, a sound such as “click” is generated. Thereby, the user can obtain a feeling of use of the microneedle 2. Moreover, since the support member 13 inverts from the concave shape to the convex shape when the load exceeds a predetermined value, the microneedle 2 sets the puncture load when the protrusion 12 is punctured to the skin S as the predetermined load. It is possible to control the puncture of the protrusion 12 into the skin.

[Third Embodiment]
FIG. 5 shows a perspective view of a microneedle according to the third embodiment of the present invention. The microneedle 3 includes a substrate 11 having a first surface 11A and a second surface 11B, a protrusion 12 formed on the first surface 11A, and a structure 14. There may be one protrusion 12 or a plurality of protrusions 12. The second surface 11B of the substrate 11 is connected to the structure 14. The structure 14 has a cavity sealed inside in a state before use.

  FIG. 6 shows an explanatory diagram of the use of the microneedle 2. In use, the microneedle 2 is first arranged so that the protruding portion 12 faces the skin S ((A) in FIG. 6, (B) in FIG. 6). When the structure 14 is pressed by the finger F toward the skin S with a force of a predetermined magnitude or more, the wall surface forming the sealed cavity of the structure 14 is destroyed, and the first of the substrate 11 is combined. The protrusion 12 on the surface 11A is punctured into the skin S ((C) of FIG. 6). When the microneedle 2 presses the structure 14, the wall surface forming the sealed cavity of the structure 14 is destroyed when the load exceeds a predetermined value. When the wall is destroyed, for example, a sound such as “bump” is generated. Thereby, the user can obtain a feeling of use of the microneedle 3. Moreover, since the structure 14 is destroyed when the load exceeds a predetermined value, the microneedle 3 can set the puncture load when the protrusion 12 is punctured to the skin S as a predetermined load. It is possible to control the puncture of the part 12 into the skin.

[Fourth Embodiment]
FIG. 7 shows a perspective view of a microneedle 4 according to the fourth embodiment of the present invention. The microneedle 4 includes a substrate 11 having a first surface 11A and a second surface 11B, a protrusion 12 formed on the first surface 11A, a structure 14, a deformation member 15, and a plate-like member 16. Including. There may be one protrusion 12 or a plurality of protrusions 12. The second surface 11B of the substrate 11 is connected to the structure 14. The structure 14 has a cavity sealed inside in a state before use. Furthermore, the structure 14 includes a plate-like member 16 on the surface opposite to the connection surface with the substrate 11. A cylindrical deformable member 15 is provided on the periphery of the protrusion 12 on the first surface 11 </ b> A of the substrate 11.

  FIG. 8 is a diagram for explaining the use of the microneedle 4. In use, the microneedles 4 are first arranged so that the protrusions 12 face the skin S (FIGS. 8A and 8B). When the plate-like member 16 is pressed with a finger F toward the skin S with a force of a predetermined magnitude or more, the wall surface forming the sealed cavity of the structure 14 is destroyed, and the first of the substrate 11 is combined. The protrusion 12 on the surface 11A is punctured into the skin ((C) of FIG. 8). At this time, the deformable member 15 is deformed (buckled) by the pressing force. When the microneedle 4 presses the plate-like member 16, when the load exceeds a predetermined value, the wall surface forming the sealed cavity of the structure 14 is destroyed. When the wall is destroyed, for example, a sound such as “bump” is generated. Thereby, the user can obtain a feeling of use of the microneedle 4. Moreover, since the structure 14 is destroyed when the load exceeds a predetermined value, the microneedle 4 can set the puncture load when the protrusion 12 is punctured to the skin S as a predetermined load. It is possible to control the puncture of the part 12 into the skin.

  The plate-like member 16 provided on the surface opposite to the connection surface of the structure 14 with the substrate 11 assists the pressing of the structure 14. The deformable member 15 provided on the first surface 11A of the substrate 11 assists the placement of the microneedles 4 on the skin. The deformable member 15 prevents the protrusion 12 from being punctured into the skin S before being pressed when the microneedle 4 is placed on the skin.

[Fifth Embodiment]
FIG. 9 shows a perspective view of a microneedle 5 according to a fifth embodiment of the present invention. The microneedle 5 includes a substrate 11 having a first surface 11A and a second surface 11B, a protrusion 12 formed on the first surface 11A, and a structure 14. There may be one protrusion or a plurality of protrusions. The first surface 11 </ b> A of the substrate 11 is connected to the structure 14 so as not to overlap the protrusion 12. The structure 14 has a cavity sealed inside in a state before use.

  FIG. 10 is a diagram illustrating how the microneedle 5 is used. In use, the microneedles 5 are first arranged so that the protrusions 12 face the skin S (FIGS. 10A and 10B). Then, when the substrate 11 is pressed against the skin S with the finger F with a force of a predetermined magnitude or more, the wall surface forming the sealed cavity of the structure 14 is destroyed, and the first surface of the substrate 11 is also combined. The protrusion 12 at 11A is punctured into the skin ((C) of FIG. 8). When the microneedle 5 presses the substrate 11, the wall surface forming the sealed cavity of the structure 14 is destroyed when the load exceeds a predetermined value. When the wall is destroyed, for example, a sound such as “bump” is generated. Thereby, the user can obtain a feeling of use of the microneedle 5. In the microneedle 5 of the present invention, since the structure 14 is destroyed when the load exceeds a predetermined value, the puncture load when the protrusion 12 is punctured into the skin S can be set as the predetermined load. It is possible to control the puncture of the protrusion 12 into the skin.

  Further, the structure 14 prevents the protrusion 12 from being punctured into the skin S before being pressed when the microneedle 5 is disposed on the skin S.

[Configuration of microneedle]
About the material used for the microneedles 1-5, it is preferable to form from the material which has biocompatibility. Examples of the material constituting the microneedles 1 to 5 include metals such as silicon, stainless steel, titanium, and manganese, and thermoplastics such as medical silicone, polylactic acid, polyglycolic acid, polycarbonate, and cyclic olefin copolymers. Examples thereof include resins. Further, the microneedles 1 to 5 may be made of a material that is dissolved by moisture contained in the skin, that is, a water-soluble material. As the water-soluble material, water-soluble polymers and polysaccharides can be used. Examples of water-soluble polymers include carboxymethylcellulose (CMC), methylcellulose (MC), hydroxypropylcellulose (HPC), hydroxypropylmethylcellulose (HPMC), polyvinyl alcohol (PVA), polyacrylic acid polymer, polyacrylamide (PAM), Examples include polyethylene oxide (PEO), pullulan, alginate, pectin, chitosan, chitosan succinamide, and oligochitosan. Examples of polysaccharides include trehalose and maltose. The protrusion 12 formed from a water-soluble material dissolves within the skin after being stabbed into the skin. In addition, the board | substrate 11 and the projection part 12 may be formed from the mutually same material, and may be formed from a mutually different material.

  Further, as the substrate 11 used for the microneedle 1, it is necessary to press the second surface 11B of the substrate 11 and to reverse the substrate 11 from a concave shape to a convex shape when the load exceeds a predetermined value. The material is appropriately selected.

  The protrusions 12 of the microneedles 1 to 5 are regions that are punctured into the skin. The protrusion 12 may have a conical shape or a pyramid shape as long as it can be punctured. Further, the protruding portion 12 may have a shape in which the tip is not sharp, for example, a cylindrical shape or a prismatic shape. Further, the protruding portion 12 may have a shape in which two or more solids are combined, such as a shape in which cones are stacked on a cylinder. Further, a constriction or a step may be formed on the side wall of the protruding portion 12, or a groove or a hole may be formed.

  The height H of the protrusions of the microneedles 1 to 5 is from the first surface 11A to the tip of the protrusion 12 in the thickness direction of the substrate 11, that is, in the direction orthogonal to the first surface 11A of the substrate 11. Length. The height H of the protrusion 12 is preferably 10 μm or more and 3000 μm or less.

  The width D of the protrusion 12 is the maximum value of the length of the protrusion 12 in the direction along the first surface 11A of the substrate 11, that is, in the direction parallel to the first surface 11A. For example, when the protrusion 12 has a regular quadrangular pyramid shape or a regular quadrangular prism shape, the length of the diagonal line in the square defined by the bottom of the protrusion 12 on the first surface 11A of the substrate 11 is the width of the protrusion 12. D. For example, when the protrusion 12 has a conical shape or a cylindrical shape, the diameter of a circle defined by the bottom of the protrusion 12 is the width D of the protrusion 12. The width D of the protrusion 12 is preferably 1 μm or more and 1 mm or less. The aspect ratio A (A = H / D), which is the ratio of the height H to the width D of the protrusion 12, is preferably 1 or more and 10 or less.

  The number of the protrusions 12 included in the microneedles 1 to 5 is not particularly limited as long as it is 1 or more. When the microneedles 1 to 5 include a plurality of protrusions 12, the plurality of protrusions 12 may be regularly arranged on the first surface 11 </ b> A of the substrate 11 or may be irregularly arranged. For example, the plurality of protrusions 12 are arranged in a lattice shape or a concentric shape.

[Configuration of support member]
The support member 13 is concave before use, and is pressed from the convex side (the surface opposite to the surface to which the substrate 11 is connected) to the concave side (the surface to which the substrate 11 is connected). At this time, the concave shape is reversed to the convex shape, and sound is generated. As the material of the support member 13, a thermoplastic resin sheet such as a metal sheet of aluminum or stainless steel or a polyethylene terephthalate film can be used. Note that it is preferable to use the support member 13 made of metal because the sound is clear.

[Structure structure]
The structure 14 has a cavity sealed inside, and a wall surface forming the cavity is ruptured by a predetermined pressure or more, and a burst sound needs to be generated. An example of such a structure 14 is a bag made of a thermoplastic resin such as polyethylene or polypropylene. For example, as a structure of the structure 14, a structure made of two polyethylene sheets, in which air is confined in a cylindrical protrusion formed by molding one sheet can be exemplified.

[Configuration of deformation member]
The deformation member 15 is a member that deforms in response to pressing. For example, a sponge-like material made of polyurethane can be exemplified. The thickness of the deformable member 15 is preferably larger than the height of the protrusion from the substrate 11 to the tip of the protrusion 12.

[Configuration of plate-like member]
Examples of the plate-like member 16 include a sheet-like material made of a thermoplastic resin such as polyethylene, polypropylene, polyethylene terephthalate, and polyacrylic acid.

  In addition, it is preferable that the microneedles 1-5 are microneedles pressed with a finger. The microneedle pressed with a finger has a poor feeling of use, and the puncture state of the microneedle into the skin tends to be different for each puncture. By using the microneedles 1 to 5, the user can obtain a feeling of using the microneedles. Moreover, the puncture speed when puncturing the microneedles into the skin can be set to a certain level or more, and the puncture of the protrusion 12 into the skin can be ensured.

<Example 1>
A silicon substrate was processed by precision machining to form a microneedle master plate in which 36 conical protrusions were arranged in a matrix of 6 columns and 6 rows. Next, a nickel film was formed on the surface of the original plate by a plating method. Then, the original plate was removed by wet etching using an aqueous potassium hydroxide solution having a weight percent concentration of 30% heated to 90 ° C. to produce an intaglio plate made of nickel in which the irregularities of the original plate were inverted.

  Next, hydroxypropylcellulose was dissolved in water to prepare an aqueous hydroxypropylcellulose solution having a weight percent concentration of 5%. The above intaglio was filled with a hydroxypropylcellulose aqueous solution, and the hydroxypropylcellulose aqueous solution filled in the intaglio together with the intaglio using a hot plate set at 90 ° C. was heated to dry and solidify the filling. After the solidified molded product was peeled from the intaglio, the molded product was punched into a circle. As a result, a molded product having a protrusion having a height of 200 μm on the substrate was obtained.

  In addition, a support member made of stainless steel was prepared. The support member has a concave shape on one surface and a convex shape on the other surface. When pressing from the convex side to the concave side with a finger, the concavo-convex shape is reversed, and at that time, a sound of “paco” occurs.

  A molded product having a protrusion on the substrate was adhered to the concave portion of the support member with an adhesive to obtain a microneedle of the present invention.

  Artificial skin was prepared, the obtained microneedles were arranged so that the protrusions and the artificial skin face each other, and the support member was pressed with a finger from the convex side. When pressed, it was confirmed that the concavo-convex shape was reversed, and at that time, a sound of “paco” was generated. Moreover, when the artificial skin after puncture was confirmed, 36 puncture marks were confirmed.

<Example 2>
A silicon substrate was processed by precision machining to form a microneedle master plate in which 36 conical protrusions were arranged in a matrix of 6 columns and 6 rows. Next, a nickel film was formed on the surface of the original plate by a plating method. Then, the original plate was removed by wet etching using an aqueous potassium hydroxide solution having a weight percent concentration of 30% heated to 90 ° C. to produce an intaglio plate made of nickel in which the irregularities of the original plate were inverted.

  Next, hydroxypropylcellulose was dissolved in water to prepare an aqueous hydroxypropylcellulose solution having a weight percent concentration of 5%. The above intaglio was filled with a hydroxypropylcellulose aqueous solution, and the hydroxypropylcellulose aqueous solution filled in the intaglio together with the intaglio using a hot plate set at 90 ° C. was heated to dry and solidify the filling. After the solidified molded product was peeled from the intaglio, the molded product was punched into a circle. As a result, a molded product having a protrusion having a height of 200 μm on the substrate was obtained.

  Moreover, the structure which consisted of the polyethylene sheet | seat and enclosed the air in the cylindrical protrusion which shape | molded one sheet | seat was prepared. The structure bursts when pressed with a finger, and a “click” sound is generated at that time. An acrylic sheet having substantially the same shape as the substrate was prepared as a plate-like member.

  The top surface and the bottom surface of the column of the structure are fixed with a plate-shaped member, and the plate-shaped member on the bottom surface and the surface of the molded product on the side opposite to the protrusion forming surface side are fixed with an adhesive. Obtained.

  Prepare artificial skin, place the obtained microneedle so that the protrusion and artificial skin face each other, and the structure in which the support member is pressed with a finger from the convex side will rupture. Was confirmed to occur. Moreover, when the artificial skin after puncture was confirmed, 36 puncture marks were confirmed.

  The present invention can be used for a microneedle.

1, 2, 3, 4, 5 Microneedle 11 Substrate 11A First surface 12A Second surface 12 Projection portion 13 Support member 14 Structure 15 Deformation member 16 Plate member

Claims (5)

A substrate comprising a first surface and a second surface;
A microneedle including a protrusion formed on the first surface of the substrate,
A microneedle that generates sound when the substrate is pressed from the second surface toward the first surface with a force of a predetermined magnitude or more. The substrate is curved concavely from the first surface toward the second surface;
When the substrate is pressed from the second surface toward the first surface with a force greater than or equal to a predetermined magnitude, the substrate is curved in a concave shape from the second surface toward the first surface. The microneedle according to claim 1, wherein the microneedle changes and generates a sound. The second surface of the substrate is connected to a plate-like support member;
The support member is concavely curved from the connection surface with the substrate toward the opposite surface of the connection surface,
When the support member is pressed from the opposite surface of the connection surface toward the connection surface with a force of a predetermined magnitude or more, the support member changes so as to bend concavely from the opposite surface of the connection surface toward the connection surface. The microneedle according to claim 1, wherein sound is generated. A second surface of the substrate is connected to the structure;
The structure has a sealed cavity inside,
When the structure is pressed toward the second surface with a force of a predetermined magnitude or more, a sound is generated by breaking a wall surface forming the sealed cavity of the structure. Item 2. The microneedle according to Item 1. The first surface of the substrate is connected to a structure;
The structure has a sealed cavity inside,
The sound is generated when a wall surface forming the sealed cavity of the structure is broken when the structure is pressed by the first surface with a force of a predetermined magnitude or more. The microneedle described.

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