Puncture assisting patch and puncture tool kit

Abstract

To provide a technique capable of accurately puncturing a skin with a puncture needle without using special means.SOLUTION: A puncture method includes a first step and the second step. In the first step, a patch 5 with a tacky adhesive 50 is attached to a planned puncture site of a skin S and a peripheral part thereof such that the tacky adhesive 50 comes into contact with the skin S. In a second step to be performed following the first step, a puncture needle 3 is punctured on a surface opposite to a surface facing the skin of the patch 5 attached to the skin S to penetrate the patch 5, and further the puncture needle 3 is punctured into the planned puncture site. This puncture method can thus highly accurately puncture the skin with the puncture needle without using special means.SELECTED DRAWING: Figure 5

Description

[Technical Field]

[0001] The present invention relates to a technique for puncturing skin with a puncture needle. [Background technology]

[0002] In recent years, transdermal absorption of drugs using liquid injection devices equipped with fine needle-like protrusions called microneedles has attracted attention in the medical and cosmetic fields. This liquid injection device makes it possible to inject drugs into the body by inserting the microneedles into a relatively shallow layer of the skin, and since the pain felt by the subject is significantly reduced compared to using a regular syringe, it has attracted attention as a non-invasive means of administering drugs.

[0003] When attempting to puncture the skin with a microneedle, the pressing force during puncture can cause the skin to elastically dent, resulting in inconveniences such as failure to puncture, or even if puncture is successful, the puncture position being shifted from the intended puncture site. As a means for solving such problems, Patent Document 1 discloses a puncture device configured to move the puncture needle with a puncture needle moving means and puncture the skin deformed by a skin deformation means. However, there is a demand for a technology that can easily and accurately puncture the skin with a microneedle without using such special means. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] International Publication No. 2007 / 052662 Summary of the Invention [Problem to be solved by the invention]

[0005] An object of the present invention is to provide a technique that enables a puncture needle to be inserted into the skin with high accuracy without using any special means. [Means for solving the problem]

[0006] The present invention provides a puncture method for puncturing skin with a puncture needle, comprising: a first step of applying an adhesive patch to the skin at the site to be punctured and its surrounding area so that the adhesive comes into contact with the skin; and a second step of inserting a puncture needle into the surface of the patch opposite to the skin-facing surface of the patch attached to the skin to penetrate the patch, and then inserting the puncture needle into the intended puncture site. The puncture method of the present invention may be one excluding medical procedures.

[0007] The present invention also provides a puncture-assisting patch that is attached to a site to be punctured on the skin and its surrounding area and is punctured together with the skin by a puncture needle, comprising: A puncture-assisting patch having at least one of the following physical properties A and B: Physical property A: A yield point is exhibited in the puncture test described below, and the yield load is 0.1 N or more and 10 N or less, and the displacement of the puncture needle at the yield point is 0.1 mm or more and 12 mm or less. Physical property B: In the tensile test described below, the maximum tensile load per unit width in the relationship between tensile load and displacement of the test piece is 1 N / mm or more and 10 N / mm or less, and the elongation at the maximum tensile load is 0.1% or more and 400% or less.

[0008] The present invention also provides a puncture device kit including a puncture needle for puncturing the skin, and a patch that is attached to the site of the skin to be punctured and its surrounding area and is punctured together with the skin by the puncture needle, The puncture needle includes a microneedle having a needle length of 30 μm or more and 1020 μm or less, or a microneedle having a needle length of 310 μm or more and 1300 μm or less, The thickness of the patch is 10 μm or more and 1000 μm or less, The thickness of the patch is thinner than the length of the puncture needle. [Effects of the Invention]

[0009] According to the present invention, the puncture needle can be inserted into the skin with high accuracy without using any special means. [Brief explanation of the drawings]

[0010] [Figure 1] FIG. 1 is a schematic perspective view of one embodiment of a microneedle, which is a type of puncture needle used in the present invention. [Figure 2] FIG. 2 is a cross-sectional view schematically showing a cross section taken along line II in FIG. 1 (a cross section along the needle length direction of the microneedle). [Figure 3] FIG. 3 is a diagram showing a state in which the microneedle shown in FIG. 1 has been punctured into the skin, and is a cross-sectional view schematically showing a cross section along the thickness direction of the skin. [Figure 4] FIG. 4 is a schematic perspective view of one embodiment of a microneedle, which is a type of puncture needle used in the present invention. [Figure 5] Figure 5 is a schematic diagram showing how a puncture needle is punctured into the skin, with Figure 5(a) and Figure 5(b) each showing an example of a puncture method of the present invention, and Figure 5(c) showing a puncture method outside the scope of the present invention. [Figure 6] FIG. 6 is an example of a graph showing the relationship between the compression load and the displacement of the puncture needle for a patch, obtained by a puncture test according to the present invention. FIG. 6(a) is an explanatory diagram of the puncture method corresponding to line a1 on the graph, and FIG. 6(b) is an explanatory diagram of the puncture methods corresponding to lines b1, b2, and b3 on the graph. [Figure 7] FIG. 7 is an example of a graph showing the relationship between the tensile load and the displacement of the test piece for the patch obtained by the tensile test according to the present invention. [Figure 8] FIG. 8 is a schematic plan view of one embodiment of the puncture-assisting patch of the present invention, viewed from the side of the surface exposed when applied. DETAILED DESCRIPTION OF THE INVENTION

[0011] The present invention will be described below based on preferred embodiments with reference to the drawings. In the following description of the drawings, the same or similar parts are designated by the same or similar reference numerals. The drawings are basically schematic, and the ratios of the dimensions may differ from those of the actual ones.

[0012] The puncturing method of the present invention is a method for puncturing the skin of a living body, including the human body, with a puncture needle. The puncturing method of the present invention can be applied to any puncture needle capable of puncturing skin, and there are no particular limitations on the material, size (needle length, thickness), shape, etc. of the puncture needle. For example, the puncture needle used in the puncturing method of the present invention may contain a resin or may have a hollow portion. The puncturing method of the present invention can be applied to any manner in which the needle of a general syringe is used to puncture the skin.

[0013] A particularly effective embodiment of the puncture method of the present invention is one in which a microneedle is used as the puncture needle. As mentioned above, when attempting to puncture the skin with a microneedle, problems such as being unable to puncture due to the elasticity or stretching of the skin can occur. The puncture method of the present invention can solve the significant problems that arise when using this microneedle in a relatively simple manner without using a special instrument such as that described in Patent Document 1.

[0014] The puncture method of the present invention can be applied to various applications such as medical care and cosmetics, and can also be used for transdermal drug administration in various applications. The puncture method of the present invention includes 1) an embodiment in which a puncture needle, typified by a microneedle, punctures a region including the stratum corneum and closer to the body surface than the stratum corneum, but does not puncture a region located inside the stratum corneum, and 2) an embodiment in which a region located inside the stratum corneum (such as the granular layer, spinous layer, basal layer, dermis, or subcutaneous tissue) is punctured. The puncture method of the present invention according to the embodiment 1) is typically for cosmetic purposes and can be called a "skin cosmetic method." In other words, the puncture method of the present invention according to the embodiment 1) does not include medical procedures. To clarify this point, the puncture method of the present invention is referred to as a "puncture method (excluding medical procedures)." The puncture method of the present invention (excluding medical procedures) typically includes a case in which a puncture needle, such as a microneedle, punctures the stratum corneum and the area closer to the body surface, but does not include a case in which a needle punctures a region located inside the stratum corneum (such as the granular layer, spinous layer, basal layer, dermis, or subcutaneous tissue). Examples of people who implement the puncture method of the present invention (excluding medical procedures) include manufacturers and sellers of cosmetics, makeup artists, beauty staff, and estheticians. The puncture method of the present invention (excluding medical procedures) can be applied, for example, as a treatment in beauty salons and other facilities that do not provide medical procedures.

[0015] As used herein, the term "microneedle" refers to a needle having a length of 2 mm or less. The "needle length" here refers to the length along the puncturing direction when the needle (including the microneedle) punctures an object to be punctured, such as skin.

[0016] In the present invention, the material of the microneedle is not particularly limited, and may be, for example, metal, but typically resin is used.The type of resin is not particularly limited, and examples thereof include thermoplastic resins such as polyfatty acid ester, polycarbonate, polypropylene, polyethylene, polyester, polyamide, polyamideimide, polyetheretherketone, polyetherimide, polystyrene, polyethylene terephthalates, polyvinyl chloride, nylon resin, and acrylic resin; hyaluronic acid, collagen, starch, and cellulose, and these can be used alone or in combination of two or more.From the viewpoint of imparting biodegradability to the microneedle, polyfatty acid ester is preferred.Specific examples of polyfatty acid ester include polylactic acid, polyglycolic acid, and combinations thereof.

[0017] 1 and 2 show a microneedle 1, which is one embodiment of a microneedle that can be used as a puncture needle in the present invention. The microneedle 1 has a flat substrate 2 and a protrusion 3 standing upright from one side of the substrate 2. The protrusion 3 functions as a puncture needle that is inserted into the skin, and has a needle length H (see FIG. 2) of 2 mm or less. The needle length H is the vertical distance from the surface of the substrate 2 facing the protrusion 3 to the tip of the protrusion 3. Unless otherwise specified, the "needle length of the microneedle" as used in the present invention refers to the length equivalent to the needle length H of the protrusion 3. In this embodiment, the protrusion 3 is conical, but in the present invention, the shape of the protrusion 3 is not particularly limited provided that it can puncture the skin, and may be, for example, a truncated cone, a cylindrical shape, a prism shape, a pyramid shape, or a truncated pyramid shape.

[0018] The apex angle θ of the protrusions 3 (see FIG. 2) is preferably 1 degree or more and 60 degrees or less, more preferably 5 degrees or more and 45 degrees or less, and even more preferably 10 degrees or more and 30 degrees or less. The apex angle θ of the protrusions 3 can be measured in accordance with the method described in

[0025] of JP2017-035432A. The tip diameter of the protrusions 3 is preferably 1 μm or more and 1000 μm or less, more preferably 5 μm or more and 500 μm or less, and even more preferably 10 μm or more and 250 μm or less. The tip diameter of the protrusions 3 can be measured in accordance with the method described in

[0018] of JP 2017-035432 A. The above-mentioned preferred ranges of the apex angle θ and tip diameter of the projection 3 basically apply to all puncture needles used in the present invention, and can also be applied to puncture needles other than microneedles.

[0019] In this embodiment, the protrusion 3 has a hollow structure and has a hollow portion 30 inside. Furthermore, in this embodiment, the microneedle 1 has an opening 31 at the tip end of the protrusion 3 (the end opposite the substrate 2 side), and the hollow portion 30 communicates with the outside of the protrusion 3 via the opening 31. Furthermore, in this embodiment, as shown in FIG. 2, the base end (the end on the substrate 2 side) of the protrusion 3 is also open. Note that the protrusion 3 does not have to have a hollow structure, and in the present invention, a so-called solid-type microneedle with a solid structure can also be used as the puncture needle.

[0020] In this embodiment, the opening 31 is located at the tip of the protrusion 3, but it may also be located at the side of the protrusion 3. This makes it possible to achieve a higher level of balance between ease of puncturing and strength during puncturing. A specific example of a microneedle having an opening formed at the side of the protrusion is that shown in Figure 2 of JP 2017-176653 A.

[0021] The hollow portion 30 functions as a reservoir or passage for the drug that is discharged to the outside from the opening 31. When the microneedle 1 is used for transdermal absorption of a drug, for example as shown in FIG. 3, the tip of the projection 3 is inserted into the skin S, and the liquid drug L stored in the hollow portion 30 is injected into the skin S through the opening 31 at the tip. The hollow portion 30 typically functions as a reservoir for the drug in this way when no drug is supplied from the outside. When a drug is supplied from the outside, for example when a drug supply device (not shown) such as an applicator is used in combination with the microneedle 1, the hollow portion 30 functions as a passage for the drug. In Figure 3, the symbol S indicates human skin. Generally, the skin S includes the epidermis S1, which includes the stratum corneum S11 constituting the surface layer of the skin S; the dermis S2, which is located inside the epidermis S1; and subcutaneous tissue (not shown), which is located inside the dermis S2. The layer S12 in the epidermis S1, which is located inside the stratum corneum S11, typically includes, in order of proximity to the stratum corneum S11, the stratum granulosum, the stratum spinosum, and the stratum basale, with the dermis S2 located inside the basal layer. When taken in the direction perpendicular to the body surface (the surface of the stratum corneum S1), the thickness of the stratum corneum S11 is typically about 0.01 mm to 0.03 mm, the thickness of the epidermis S1 (the total thickness of both layers S11 and S12) is about 0.1 mm to 0.3 mm, and the thickness of the dermis S2 is about 1 mm to 4 mm.

[0022] In the microneedle 1, the substrate 2 and the protrusions 3 are made of the same material and are integrally molded. Specifically, the microneedle 1 is formed by pressing a convex shape having the same external shape as the protrusions 3 from one side of a raw material sheet made of a thermoplastic resin or the like to the other side, and deforming the pressed portion into the shape of the convex shape, with the deformed portion of the raw material sheet being the protrusions 3 and the non-deformed portion of the raw material sheet being the substrate 2.

[0023] 4 shows a microneedle array 4, which is another embodiment of the puncture needle that can be used in the puncture method of the present invention. Regarding the microneedle array 4, the configuration that differs from the microneedle 1 described above will be mainly described, and similar configurations will be assigned the same reference numerals and will not be described again. For configurations of the microneedle array 4 that are not specifically described, the description of the microneedle 1 described above will be applied as appropriate.

[0024] The microneedle array 4 is a type of microneedle, and as shown in FIG. 4, has a configuration in which a plurality of protrusions 3 are arranged on one side of a flat substrate 2. The plurality of protrusions 3 have the same shape and dimensions. The plurality of protrusions 3 are arranged in close proximity to each other; specifically, the pitch between two adjacent protrusions 3, 3, i.e., the distance between the centers of each of two adjacent protrusions 3, 3 in a plan view (top view), is within 2 mm. The number and arrangement pattern of the protrusions 3 in the microneedle array 4 are not particularly limited and can be set appropriately depending on the application of the microneedle array 4, etc. In the microneedle array 4, the substrate 2 and the plurality of protrusions 3 are made of the same material and are molded integrally.

[0025] The puncture method of the present invention is characterized in that, prior to inserting a puncture needle into the intended puncture site in the skin, a patch is applied to the intended puncture site and its surrounding area, and the intended puncture site is punctured through the patch. The patch is typically a so-called adhesive tape. Specifically, the puncture method of the present invention includes a first step and a second step. In the first step, a patch having an adhesive is attached to the skin at the site to be punctured and its surrounding area so that the adhesive comes into contact with the skin. In the second step, which follows the first step, a puncture needle is inserted into the surface of the patch attached to the skin opposite the skin-facing surface to penetrate the patch, and then the puncture needle is inserted into the site to be punctured.

[0026] Figure 5 shows how the protrusions 3 of the microneedles 1 function as puncture needles and puncture the skin S. Figures 5(a) and 5(b) are both examples of the puncture method of the present invention, and Figure 5(c) is a general puncture method that has been conventionally implemented. FIG. 5(c) shows an example in which the protrusions 3 are directly punctured into the skin S without attaching anything to the surface of the skin S, i.e., the body surface (surface of the stratum corneum) S0. In the puncturing method of FIG. 5(c), the pressure of the protrusions 3 causes the superficial layer of the skin S (such as the stratum corneum) to stretch in the plane of the body surface S0 or to elastically recess in a direction intersecting the body surface S0. This can make puncturing difficult. Even if puncturing is successful, inconveniences such as the puncturing position being shifted from the intended puncture site can occur. The dashed-dotted line VL in the figure indicates the position (initial position) of the body surface S0 before pressure by the protrusions 3. In the puncturing method of FIG. 5(c), because the skin S is highly elastic and easily stretches, the site on the body surface S0 pressed by the protrusions 3 (the intended puncture site) and its surrounding area are relatively deeply recessed inward from the initial position VL. In contrast, in the puncture method of the present invention, as shown in Figures 5(a) and 5(b), a patch 5 having an adhesive 50 is attached to the body surface S0 so that the adhesive 50 comes into contact with the body surface S0. Next, the protrusions 3 are caused to penetrate the patch 5 before puncturing the skin S, so that deformation of the skin S due to pressure from the protrusions 3 is suppressed by the patch 5. Therefore, the protrusions 3 can be accurately punctured into the site of the skin S to be punctured. This is thought to be because, by attaching the patch 5 with adhesive 50 to the body surface S0, the portion of the superficial layer of the skin S that overlaps with the patch 5 in a planar view is constrained, making it less likely to deform even when subjected to an external force. According to the puncture method of the present invention, the position of the area on the body surface S0 pressed by the protrusion 3 (the area to be punctured) and its surrounding area hardly changes from the initial position VL before and after the puncture with the protrusion 3 (see Figure 5(a)), or even if it does change, the degree of change is smaller than that of the conventional puncture method as shown in Figure 5(c) (see Figure 5(b)).

[0027] The main difference between the puncture method of FIG. 5(a) and the puncture method of FIG. 5(b) is the hardness of the patch 5, more specifically, the hardness and resistance to stretching of the substrate 51 that constitutes the patch 5. That is, in this embodiment, the patch 5 has a configuration in which an adhesive 50 is applied to one side of a sheet-like substrate 51, and the substrate 51 in FIG. 5(a) is harder and less likely to stretch than the substrate 51 in FIG. 5(b). If the substrate 51 is relatively hard and less likely to stretch, the degree of deformation when punctured with a puncture needle such as the protrusion 3 is relatively small. If the substrate 51 is relatively flexible and easily stretched, the degree of deformation when punctured with the puncture needle is relatively large. In either case, the protrusion 3 can be accurately punctured into the intended puncture site of the skin S.

[0028] If a drug is contained in the hollow portion 30 of the protrusion 3 (puncture needle), in the second step, the protrusion 3 (puncture needle) is inserted into the intended puncture site as shown in Figures 5(a) and 5(b), and the drug is injected into the body through the intended puncture site. The puncture needle used in the present invention includes, for example, so-called solid-type microneedles with a solid structure. In an embodiment using such a puncture needle without a hollow portion, when transdermal injection of a drug using the puncture needle may be performed, for example, 1) a puncture needle coated with a drug on its outer surface, 2) a puncture needle with a drug flow path on its outer surface (side), or 3) a puncture needle composed of a drug. Since the puncture needle of the type 3) is itself a drug, it may be unnecessary to remove it from the skin after puncturing it. For example, if the puncture needle of the type 3) is a microneedle having a base plate and protrusions extending from one side of the base plate, such as the microneedle 1 described above, and the protrusions are composed of a drug, after puncturing the skin with the protrusions, the base plate can be separated from the protrusions, leaving the protrusions in a state of being stuck in the skin. The puncture method of the present invention encompasses embodiments using the puncture needles of the types 1) to 3). The drug can be any drug that can be injected transdermally using a puncture needle, and examples thereof include moisturizers, anti-wrinkle agents, whitening agents, blood circulation promoters, anti-blemish agents, and antioxidants. The drug may also be one used in skin beauty treatment methods.

[0029] In the second step, the skin is punctured through the patch with the puncture needle, and after injecting the drug into the body as needed, the puncture needle is withdrawn from the skin and the patch. Typically, the series of skin puncture procedures is completed with this withdrawal of the puncture needle.

[0030] Typically, when the puncture needle that has penetrated the patch is removed from the patch, the portion of the patch that was pushed aside by the puncture needle when it penetrated deforms to close the opening created when the puncture needle was removed, protecting the punctured site on the skin. From the perspective of protecting the skin, it is ideal for the opening to be completely closed after the puncture needle that has penetrated the patch is removed. Even if the opening is not completely closed, closing it to some extent is effective in protecting the skin. From this perspective, if the maximum area of ​​the puncture needle's penetration site in the patch when it is penetrated by the puncture needle is Q1, and the opening area of ​​the opening formed at the penetration site after the puncture needle is removed from the patch on the surface of the patch opposite to the skin-facing surface, the ratio of Q2 to Q1 (Q2 / Q1) is preferably 0.001 or more, more preferably 0.01 or more, and preferably 0.3 or less, more preferably 0.1 or less. The areas Q1 and Q2 can be measured using a microscope by observing the measurement site (the penetration site of the puncture needle in the patch and the opening formed at the penetration site) and measuring the areas Q1 and Q2 using a conventional method based on the observed image.

[0031] The ratio (Q2 / Q1) can be adjusted by appropriately adjusting the types of materials (substrate, adhesive) constituting the patch, the basis weight, etc. An example of a patch in which the ratio (Q2 / Q1) is likely to fall within the preferred range is one in which the substrate is polyethylene and the adhesive is an acrylic resin.

[0032] The patch 5 is typically in the form of a sheet, and is configured to include a sheet-like substrate 51 and an adhesive 50 disposed on at least one surface of the substrate 51. As the adhesive 50, any known adhesive can be used without any particular limitation, and examples of adhesives that can be used include acrylic, silicone, urethane, polyvinyl butyral, polyvinyl ether, ethylene-vinyl acetate, polyolefin, SBR, and rubber-based adhesives. Basically, adhesive tapes used for various purposes such as medical use and packaging can be used as the patch 5. However, not just any adhesive tape will do, and it is necessary that the patch 5 can exert the skin restraint function described above.

[0033] Examples of materials for the substrate 51 include resin films, nonwoven fabrics, woven fabrics, and paper, and may also be composite sheets in which two or more of these materials are laminated. In particular, from the viewpoint of improving puncture resistance, the substrate 51 preferably includes a resin film or nonwoven fabric.

[0034] A preferred example of the patch 5 is one in which at least one of the adhesive 50 and the substrate 51 contains a biocompatible material (biocompatible material). Here, "biocompatible" refers to having no harmful effects on living organisms, such as being non-toxic to the human body, not causing allergic reactions, not being carcinogenic, not causing metabolic disorders, or being safe. If at least one of the adhesive and the substrate satisfies one or more of these criteria, the patch can be evaluated as having biocompatibility. By including a biocompatible material in the patch 5, concerns about adverse effects on the living organism to which the patch 5 is attached can be eliminated.

[0035] The thickness of the patch 5, i.e., the thickness of the laminate of the pressure-sensitive adhesive 50 and the substrate 51, is preferably from 10 μm to 1000 μm, more preferably from 30 μm to 500 μm, and even more preferably from 50 μm to 250 μm, from the viewpoint of enabling penetration by a puncture needle while reliably ensuring the skin restraint function of the patch 5. The thickness of the patch used in the present invention is measured by the following method.

[0036] <Method for measuring the thickness of the patch> Measurements are taken according to standard methods using a constant pressure thickness measuring device (PG-02J, manufactured by TECLOCK CORPORATION). Measurements are taken at five different points on the patch to be measured, and the average of the five measurements is the thickness of the patch to be measured.

[0037] Preferred examples of combinations of puncture needles and patches used in the puncture method of the present invention include the following combinations A and B. As can be seen from the needle lengths of the puncture needles below (corresponding to needle length H in Figure 2), the puncture needles in each of combinations A and B are microneedles with a needle length of 2 mm or less. In either combination, it is preferable that the thickness of the patch is thinner than the needle length of the puncture needle.

[0038] (Combination A) · Patch: The thickness is within the preferred range for the patch 5 described above. · Puncture needle: needle length is preferably 30 μm or more and 1020 μm or less, more preferably 50 μm or more and 520 μm or less, and even more preferably 70 μm or more and 270 μm or less. Combination A is particularly useful when inserting a puncture needle (microneedle) into a region that includes the stratum corneum and is closer to the body surface than the stratum corneum.

[0039] (Combination B) · Patch: The thickness is within the preferred range for the patch 5 described above. · Puncture needle: needle length is preferably 310 μm or more and 1300 μm or less, more preferably 330 μm or more and 800 μm or less, and even more preferably 350 μm or more and 550 μm or less. Combination B is particularly useful when the puncture needle (microneedle) is inserted into a depth deeper than the stratum corneum, specifically into the epidermis, dermis, or subcutaneous tissue.

[0040] To further explain the patch, which is one of the main features of the present invention, i.e., the puncture-assisting patch that is attached to the area of ​​the skin to be punctured and its surrounding area and is punctured together with the skin by the puncture needle, the puncture-assisting patch preferably has at least one of the following physical properties A and B, and more preferably has both: Physical property A: The puncture test below shows a yield point, and the yield load is between 0.1N and 10N, and the displacement of the puncture needle at the yield point is between 0.1mm and 12mm. · Physical property B: In the tensile test below, the maximum tensile load per unit width in the relationship between tensile load and test piece displacement is 1 N / mm or more and 10 N / mm or less, and the elongation rate at the maximum tensile load is 0.1% or more and 400% or less.

[0041] (Puncture test) A test specimen was cut out from the patch to be tested in its natural state in a square shape measuring 20 mm on each side in plan view. The test specimen was a laminate consisting of a simulated stratum corneum made of a 20 μm thick polyethylene film and a 5 mm thick simulated skin. Skin A skin model is used. A test piece is attached to the surface of the simulated stratum corneum, and a puncture needle is pressed into the test piece perpendicular to the surface of the simulated stratum corneum using a compression tester at a speed of 60 mm / min. The relationship between the compression load and the displacement of the puncture needle is determined, and the presence or absence of a yield point is determined from this relationship. If a yield point is found, the yield load and the displacement of the puncture needle at the yield point are determined. The test environment is an ambient temperature of 23°C and a humidity of 50% RH. The puncture needle is a polylactic acid puncture needle (microneedle) with a needle length of 1.5 mm, a tip diameter of 40 μm, and an apex angle of 11°.

[0042] For the puncture test, Viewlux's "BioSkin" was used as the simulated skin constituting the skin model. A square shape measuring 40 mm x 40 mm in plan view was cut out from the BioSkin in its natural state, and one side of the cut BioSkin was covered with a simulated stratum corneum (a 20 μm-thick polyethylene stretch film) to obtain a skin model. Shimadzu Corporation's "AG-IS 100N" compression tester was used. When pressing the puncture needle into the test piece, the skin model with the test piece attached was placed directly below the puncture needle provided in the compression tester, with the tip (vertex angle side) of the puncture needle serving as the tip in the pressing direction.

[0043] (Tensile test) A rectangular test piece measuring 18mm x 50mm in plan view is cut out from the adhesive test piece in its natural state. The test piece is pulled in its longitudinal direction using a tensile tester, and the relationship between the tensile load and the displacement of the test piece is determined. From this relationship, the maximum tensile load per unit width and the elongation at the maximum tensile load are determined. The distance between the pair of gripping jigs in the tensile tester is 30mm, and the tensile load is 2mm / min. The test environment is an ambient temperature of 23°C and humidity of 50%RH.

[0044] For the tensile test, a Shimadzu Autograph AGX-plus manufactured by Shimadzu Corporation can be used as the tensile tester. When the test piece is fixed between a pair of gripping jigs in the tensile tester, one of the pair of gripping jigs grips a portion of the test piece extending from one end in the longitudinal direction to a position 10 mm inward in the longitudinal direction, and the other of the pair of gripping jigs grips a portion of the test piece extending from the other end in the longitudinal direction to a position 10 mm inward in the longitudinal direction, so that the distance between the pair of gripping jigs (gauge length) is 30 mm.

[0045] An example of a graph showing the relationship between the compression load and the displacement of the puncture needle obtained by the puncture test is shown in Figure 6. The graph in Figure 6 shows four types of lines a1, b1, b2, and b3. Line a1 in the graph of Figure 6 represents a case in which the puncture method of the present invention was not applied. That is, line a1 represents the relationship between the "compression load and the displacement of the puncture needle" in a case in which, as shown in Figure 6(a), a microneedle 14 connected to a load cell 13 of a compression tester was directly pressed into a skin model 12 consisting of a simulated stratum corneum 10 and simulated skin 11 from the side of the simulated stratum corneum 10 in a direction perpendicular to the surface of the simulated stratum corneum 10 at a constant speed. On the other hand, lines b1, b2, and b3 in the graph of Fig. 6 are for an embodiment in which the puncture method of the present invention is applied. That is, lines b1, b2, and b3 respectively show the relationship between the "compression load and the amount of displacement of the puncture needle" in an embodiment in which the patch 5 is attached to the intended puncture site and its surrounding area on the surface of the simulated stratum corneum 10, and the microneedle 14 is pressed into the patch 5, as shown in Fig. 6(b). The test conditions for line a1 and lines b1, b2, and b3 are the same except that the former did not use patch 5. Furthermore, lines b1, b2, and b3 used different patches. As a result, in the embodiment shown in Figure 6(a) where a patch was not used, the skin model 12 was elastically deformed by the pushing of the microneedles 14, and the microneedles 14 did not penetrate the skin model 12. In contrast, in the embodiment shown in Figure 6(b) where a patch was used, the microneedles 14 penetrated the patch 5 and penetrated the skin model 12. In the graph of FIG. 6, the vertical axis represents the compression load (puncture load) and the horizontal axis represents the displacement of the microneedle 14 (puncture needle). While the line a1 in the embodiment of FIG. 6(a) does not have a yield point, the lines b1, b2, and b3 in the embodiment of FIG. 6(b) do. The "yield point" referred to here is the first peak that appears when the puncture needle starts from a zero displacement in the graph showing the relationship between the compression load and the displacement of the puncture needle, as shown in FIG. 6. In the embodiment of FIG. 6(b), the yield point appears when the microneedle 14 penetrates the patch 5. The compression load at which the yield point is indicated (the value on the vertical axis of the graph in FIG. 6) is the "yield load" in the physical property A, and the displacement of the microneedle 14 at which the yield point is indicated (the value on the horizontal axis of the graph in FIG. 6) is the "displacement of the puncture needle at the yield point" in the physical property A.

[0046] As mentioned above, a puncture-assisting patch is required to have the function of restraining deformation of the surface layer of the skin due to pressure when the puncture needle is punctured into the skin. In this regard, a patch having the above physical property A exhibits a yield point in the puncture test, and the yield load and the displacement of the puncture needle at the yield point are both within appropriate ranges, so it has excellent puncture properties and is useful as a puncture-assisting patch. In the above-mentioned physical property A, the yield load of the patch is preferably 0.1N or more and 10N or less, more preferably 0.25N or more and 4N or less, and even more preferably 0.5N or more and 1.5N or less. In the above-mentioned property A, the displacement of the puncture needle at the yield point is preferably 0.1 mm or more and 12 mm or less, more preferably 0.2 mm or more and 5 mm or less, even more preferably 0.25 mm or more and 2.5 mm or less, and even more preferably 0.5 mm or more and 2.2 mm or less.

[0047] FIG. 7 shows an example of a graph showing the relationship between the tensile load and the displacement of the test piece obtained by the tensile test. The vertical axis of the graph in FIG. 7 represents the tensile load, and the horizontal axis represents the displacement of the test piece (applied body) (the displacement of the gauge length). The graph in FIG. 7 shows the test results for five types of applied bodies, with the symbol (a) attached to the line corresponding to one of the types. For example, for applied body (a), the tensile load increased with the increase in the displacement from the beginning of the tensile test, and the test piece broke when the displacement exceeded 4 mm, and the tensile load suddenly dropped. The tensile load at the time of break (maximum tensile load) divided by the length (width) (18 mm) of the test piece in the direction perpendicular to the tensile direction is the "maximum tensile load per unit width" in the physical property B. The ratio of the displacement of the test piece when the tensile load is applied to the gauge length (30 mm) is the "elongation at maximum tensile load" in the physical property B.

[0048] With regard to the tensile properties of such a patch, by making the maximum tensile load of the patch equal to or less than a predetermined upper limit, it becomes easy to puncture the patch with a puncture needle. In particular, when the puncture needle is a resin microneedle, when the needle is inserted into the patch, the tip of the microneedle can be punctured without deformation. On the other hand, by ensuring that the maximum tensile load is equal to or greater than a predetermined lower limit, the strength of the patch is ensured and deformation of the skin can be suppressed. By keeping the elongation rate of the patch under maximum tensile load at or below a predetermined upper limit, deformation of the skin is suppressed, making it easier to puncture with a puncture needle such as a microneedle. A patch having the above-mentioned property B has a maximum tensile load and an elongation rate at maximum tensile load each in an appropriate range, and therefore has excellent tensile properties and is useful as a puncture-assisting patch. In the physical property B, the maximum tensile load per unit width in the relationship between the tensile load and the displacement of the test piece is preferably 1 N / mm or more and 10 N / mm or less, more preferably 1.2 N / mm or more and 4.4 N / mm or less, and even more preferably 1.5 N / mm or more and 4.0 N / mm or less. In the property B, the elongation percentage under maximum tensile load is preferably 0.1% or more and 400% or less, more preferably 0.5% or more and 300% or less, and even more preferably 1% or more and 100% or less.

[0049] When a graph is created based on the results of the tensile test, as shown in Figure 7, with the vertical axis representing the tensile load and the horizontal axis representing the displacement of the test piece (patch), the maximum slope of the graph per unit width is preferably 10 N / mm or more and 300 N / mm or less, more preferably 30 N / mm or more and 200 N / mm or less, and even more preferably 50 N / mm or more and 100 N / mm or less. The "maximum slope of the graph per unit width" is calculated by the following method. Patches whose maximum slope of the graph per unit width falls within the above-mentioned preferred range have particularly excellent tensile properties and are useful as puncture-assisting patches.

[0050] <How to calculate the maximum graph slope per unit width> First, based on the results of the tensile test, a graph is created in which the vertical axis represents the tensile load and the horizontal axis represents the amount of displacement of the test piece (adhesive body), as shown in FIG. Next, for the target line (hereinafter also referred to as the "target line") in the created graph, calculate the slope of the graph per unit width (the gradient of the line connecting two points spaced apart by 0.5% strain) for every 0.5% strain in the range from the start of the tensile test to the time when the test piece (adhesive body) breaks (the time when it shows the maximum tensile load) using the following formula. Graph slope per unit width (N / mm) = (P2-P1) / (ε2-ε1) × H / B In the formula, "P1" represents the tensile load (unit: N) of the smaller of the two points spaced apart by a 0.5% strain on the target line, and "P2" represents the tensile load (unit: N) of the larger of the two points. Also in the formula, "ε1" represents the displacement (unit: mm) of the test piece at the smaller of the two points spaced apart by a 0.5% strain on the target line, and "ε2" represents the displacement (unit: mm) of the larger of the two points. Also in the formula, "H" represents the gauge length (30 mm), and "B" represents the width (18 mm) of the test piece. In the formula, "ε2 - ε1" = 0.5%, i.e., a 0.5% strain interval. The "strain" is calculated by the displacement / gauge length. Then, the largest value among the multiple "graph slopes per unit width" obtained by the above method is determined as the "maximum graph slope per unit width" of the target line.

[0051] From the viewpoint of ensuring that the intended effects of the present invention are achieved more reliably, the hardness of the puncture-assisting patch, measured by the method described below, is preferably 10 or more, more preferably 12 or more, and preferably 18 or less, more preferably 20 or less. The higher the numerical value, the harder the patch is evaluated to be. If the patch is not hard enough (i.e., too soft), it may follow the deformation of the skin and not be able to be punctured, and if the patch is too hard, it may be difficult to puncture with the puncture needle, etc.

[0052] <Hardness measurement method> Hardness measurements are performed in accordance with JIS K 6253-3. A durometer (GSD-719K-H (type A) manufactured by Flock Co., Ltd.) is used to measure hardness, and the test load is 193.3 g (measurement device weight). First, a skin model was prepared. Specifically, a square shape measuring 40 mm × 40 mm in plan view and 5 mm thick was cut out of simulated skin in its natural state, and one side of the cut-out simulated skin was covered with a simulated stratum corneum (a 20 μm-thick polyethylene stretch film) to obtain the skin model. The simulated skin used was "Bioskin" from Viewlux Co., Ltd. A rectangular shape measuring 18 mm × 40 mm in plan view was cut out of the patch to be tested in its natural state to prepare a test piece. The test piece was then attached to the surface of the simulated stratum corneum of the skin model, and the hardness was measured using the durometer according to standard methods at five random points at least 6 mm apart in an area at least 12 mm from the periphery of the test piece. The median of the measurements at these five points was taken as the hardness of the test piece. The test environment was an ambient temperature of 23°C and humidity of 50% RH.

[0053] The puncture-assisting patch of the present invention typically has an adhesive on its outer surface and is attached to the skin, which is the target, via the adhesive. Specific examples of puncture-assisting patches include those having the same configuration as the above-mentioned patch 5 (see FIG. 5), i.e., a configuration in which an adhesive is arranged on at least one surface of a sheet-like substrate. The adhesive strength of the puncture-assisting patch, when attached to the surface of the simulated stratum corneum used in the puncture test via the adhesive contained in the patch, is preferably 0.5 N / 10 mm or more and 16 N / 10 mm or less, more preferably 1 N / 10 mm or more and 8.0 N / 10 mm or less, and even more preferably 2.0 N / 10 mm or more and 4 N / 10 mm or less. When the adhesive strength of the patch is within the above-mentioned preferred range, the patch is reliably fixed to the skin, the above-mentioned skin restraint function is more reliably exerted, and the patch can be smoothly removed from the skin after use.

[0054] The puncture-assisting patch of the present invention may have a mark indicating the puncture position of the puncture needle. When the puncture needle is inserted into a patch having a mark, the puncture needle is usually inserted into the mark. When the patch has a mark, the puncture operator can easily recognize the puncture position, making it possible to perform the puncture operation smoothly and accurately. In order to ensure that the markings fulfill their role, it is preferable that they be provided at least on the surface of the patch opposite the skin-facing surface, i.e., the surface that is exposed when the patch is attached to the skin (hereinafter also referred to as the "surface exposed when attached").

[0055] A specific example of the mark is a recessed portion having an opening at least on the surface of the patch that is exposed when the patch is attached. The recessed portion may be a through-hole that penetrates the patch in the thickness direction, in which case the recessed portion also has an opening on the surface of the patch opposite to the surface that is exposed when the patch is attached (the surface facing the skin). The shape of the recessed portion in a plan view is not particularly limited, and may be, for example, a circle, a square, or the like. The circle-equivalent diameter of the recessed portion is preferably 2.5 μm or more and 2000 μm or less, more preferably 5 μm or more and 1000 μm or less, and even more preferably 10 μm or more and 500 μm or less, from the viewpoint of ensuring the function as a marker for the depression or opening while maintaining the basic performance of the patch (strength, adhesive power, etc.) at a practically sufficient level. The "circle-equivalent diameter" referred to here refers to the diameter of the smallest circle that encompasses the recessed portion.

[0056] Another specific example of the mark is a notch extending in one direction. The notch may penetrate the patch in the thickness direction. The length (width) in the direction perpendicular to the extension direction of the incision is preferably 2.5 μm or more and 2000 μm or less, more preferably 5 μm or more and 1000 μm or less, and even more preferably 10 μm or more and 500 μm or less, from the viewpoint of maintaining the basic performance of the patch (strength, adhesive force, etc.) at a practically sufficient level while ensuring the function of the incision as a marker.

[0057] The puncture-assisting patch of the present invention can also be applied to puncture operations using a microneedle array in which a plurality of protrusions with a needle length of 2 mm or less are arranged on one side of a substrate, such as the microneedle array 4 shown in Fig. 4. In this case, each of the plurality of protrusions on the microneedle array functions as a puncture needle. The puncture-assisting patch of the present invention may have a positioning mechanism for the microneedle array. Figure 8 shows the surface of a patch 5 that is exposed when attached, which is a specific example. The surface of the patch 5 that is exposed when attached (the outer surface of the base material 51) shown in Figure 8 is provided with a mark 52 that corresponds to the outline of the substrate 2 (see Figure 4) that the microneedle array 4 is provided with, as a positioning mechanism for the microneedle array 4. When the puncture method of the present invention is carried out using the microneedle array 4, after the patch 5 shown in Figure 8 is attached to the skin, the microneedle array 4 may be punctured into the patch 5 while the substrate 2 of the microneedle array 4 is aligned so that it coincides with the mark 52 on the patch 5. The form of the mark 52 is not particularly limited, and may be, for example, a flat printed matter on which a predetermined pattern is printed, or a three-dimensional mark such as a recess or notch.

[0058] The present invention encompasses a puncture kit comprising a puncture needle for puncturing the skin and a patch that is attached to the site of the skin to be punctured and its surrounding area and is punctured together with the skin by the puncture needle. The above-mentioned explanations regarding the puncture method and puncture-assisting patch of the present invention apply appropriately to the puncture kit (puncture needle, patch) of the present invention.

[0059] The puncture device kit of the present invention 1) comprises a patch (puncture-assisting patch) having a thickness of 10 μm or more and 1000 μm or less and a microneedle having a needle length of 30 μm or more and 1020 μm or less, or 2) comprises a patch (puncture-assisting patch) having a thickness of 10 μm or more and 1000 μm or less and a microneedle having a needle length of 310 μm or more and 1300 μm or less. 1) is the same as combination A, and 2) is the same as combination B. In both combinations, the thickness of the patch is thinner than the needle length of the puncture needle.

[0060] The present invention has been described above based on its preferred embodiments, but the present invention is not limited to the above embodiments and can be modified as appropriate within the scope of the invention. [Example]

[0061] The present invention will be explained in more detail below with reference to examples, but the present invention is not limited to these examples.

[0062] [Examples 1 to 5, Comparative Example 1] The following puncture evaluation test was carried out. The results, along with the physical properties of the patches used, are shown in Table 1 below. Regarding the "presence or absence of yield point" in Table 1 below, the puncture test was carried out four times for each type of patch tested, and if a yield point was confirmed in two or more of these tests, it was recorded as "yield point present," and if a yield point was confirmed in one or fewer tests, it was recorded as "yield point absent."

[0063] <Puncture resistance evaluation test> The puncture needle was manually pushed into the surface of the skin model in a direction perpendicular to the surface of the skin model, and when the puncture needle penetrated the skin model, it was deemed a "successful puncture." The puncture needle used was the same as the puncture needle (microneedle) used in the puncture test. This test was performed four times for one type of evaluation subject (four tests in total), and the number of successful punctures was counted. The more successful punctures, the higher the evaluation. A laminate (weight 193.3 g) of a simulated stratum corneum and a 10 mm thick simulated skin was used as the skin model. The simulated stratum corneum formed the surface of the skin model. As in the puncture test and hardness measurement, a 20 μm thick polyethylene stretch film was used as the simulated stratum corneum. As the material for the simulated skin, "BioSkin" manufactured by Viewlux Co., Ltd. was used, and the simulated skin was prepared by stacking two 5 mm thick, 40 mm square BioSkin sheets. A sheet with a basis weight of 13 g / m2 was placed between the simulated stratum corneum (stretch film) and the simulated skin (BioSkin). 2 A piece of tissue paper was placed between the two. The patch to be attached to the surface (simulated stratum corneum) of the skin model had a rectangular shape measuring 18 mm x 50 mm in plan view in its natural state. When the puncture needle was pushed into the patch, the puncture needle was pushed into the surface of the patch in a region at the center of the patch's short side and at least 12 mm away from each of the patch's longitudinal ends. Furthermore, before the puncture needle was pushed into the patch, a coloring liquid prepared by adding a dye to water was applied to the surface of the puncture needle before the needle was pushed into the patch. In this way, if the puncture was successful, the tissue paper would be colored with the coloring liquid, allowing visual confirmation of whether the puncture needle had penetrated the skin model. This evaluation test was carried out four times for each type of evaluation subject, and the puncture was evaluated as successful when coloring of the tissue paper was confirmed.

[0064] [Table 1]

[0065] As shown in Table 1, when an attempt was made to puncture the skin model directly with the puncture needle without using a patch, puncture was not possible (Comparative Example 1). In contrast, in each example, a patch was attached to the surface of the skin model so that the skin model was punctured through the patch, and therefore the puncture needle was able to puncture the skin model. The "hardness of the target to be punctured by the puncture needle" in Table 1 was measured according to the above-mentioned <Method for measuring hardness>, and for Comparative Example 1, the measurement was made without attaching a patch (test piece) to the skin model. That is, the "hardness of the target to be punctured by the puncture needle" in Comparative Example 1 is the hardness of the surface layer (simulated stratum corneum) of the skin model. Since the hardness values ​​of each Example are larger and harder than those of Comparative Example 1, it can be seen that attaching a patch to the target to be punctured by the puncture needle hardens the target.

[0066] [Example of puncture for cosmetic purposes] The patch of Example 1 was applied, and the puncture test was repeated except that a puncture needle (microneedle) made of polylactic acid with a needle length of 160 μm, a tip diameter of 40 μm, and an apex angle of 11° was used. The microneedle was pushed in until its substrate came into contact with the patch. As a result, the yield point was confirmed, and it was determined that the microneedle penetrated the patch, and a portion equivalent to 30 μm from the tip of the microneedle, which is the difference between the needle length of 160 μm and the thickness of the patch of 130 μm, punctured the simulated stratum corneum (stretch film) of the skin model.

[0067] [Example of puncture for medical use] The patch of Example 1 was applied, and the puncture test was repeated except that a puncture needle (microneedle) made of polylactic acid with a needle length of 1000 μm, a tip diameter of 40 μm, and an apex angle of 11° was used. The microneedle was pushed in until its substrate came into contact with the patch. As a result, the yield point was confirmed, and it was determined that the microneedle penetrated the patch, and a portion equivalent to 870 μm from the tip of the microneedle, which is the difference between the needle length of 1000 μm and the thickness of the patch of 130 μm, punctured the simulated stratum corneum (stretch film) of the skin model. [Explanation of symbols]

[0068] 1. Microneedle 2 boards 3 protrusion (puncture needle) 30 Hollow part 31 Opening 4. Microneedle array 5. Patch 50 adhesive 51 Base material 52 Landmark

Claims

1. A puncture-assisting patch that is attached to a site to be punctured on the skin and its surrounding area and is punctured together with the skin by a puncture needle, A puncture-assisting patch having the following physical property A. Physical property A: In the puncture test described below, it exhibits a yield point, the yield load is 0.7 N or more and 10 N or less, and the displacement of the puncture needle at the yield point is 0.1 mm or more and 2.2 mm or less. (Puncture test) A test piece was prepared by cutting a square shape measuring 20 mm on each side in a planar view from the patch to be tested in its natural state. A skin model consisting of a laminate of a simulated stratum corneum made of a 20 μm thick polyethylene film and a 5 mm thick simulated skin was used as the target for the test piece to be attached. A test piece was attached to the surface of the simulated stratum corneum, and a puncture needle was pressed into the test piece perpendicular to the surface of the simulated stratum corneum using a compression tester at a speed of 60 mm / min, and the relationship between the compression load and the displacement of the puncture needle was determined.The presence or absence of a yield point was determined from this relationship, and if there was a yield point, the yield load and the displacement of the puncture needle at the yield point were determined.The test environment was an ambient temperature of 23°C and a humidity of 50% RH. The puncture needle used is made of polylactic acid and has a needle length of 1.5 mm, a tip diameter of 40 μm, and an apex angle of 11°.

2. A puncture-assisting patch as described in claim 1, which is separate from the puncture needle, has an area of ​​20 mm square or more in a plan view, and is 50 μm or more in thickness.

3. A puncture-assisting patch that is attached to the intended puncture site of the skin and its surrounding area, and that is punctured together with the skin by a puncture needle that is separate from the puncture-assisting patch, A puncture-assisting patch having an area of ​​20 mm square or more in plan view, a thickness of 50 μm or more, and at least one of the following physical properties A and B. Physical property A: In the puncture test described below, it exhibits a yield point, the yield load is 0.1 N or more and 10 N or less, and the displacement of the puncture needle at the yield point is 0.1 mm or more and 12 mm or less. Physical property B: In the tensile test described below, the maximum tensile load per unit width in the relationship between the tensile load and the displacement of the test piece is 1 N / mm or more and 10 N / mm or less, and the elongation at the maximum tensile load is 0.1% or more and 400% or less. (Puncture test) A test piece was prepared by cutting a square shape measuring 20 mm on each side in a planar view from the patch to be tested in its natural state. A skin model consisting of a laminate of a simulated stratum corneum made of a 20 μm thick polyethylene film and a 5 mm thick simulated skin was used as the target for the test piece to be attached. A test piece was attached to the surface of the simulated stratum corneum, and a puncture needle was pressed into the test piece perpendicular to the surface of the simulated stratum corneum using a compression tester at a speed of 60 mm / min, and the relationship between the compression load and the displacement of the puncture needle was determined.The presence or absence of a yield point was determined from this relationship, and if there was a yield point, the yield load and the displacement of the puncture needle at the yield point were determined.The test environment was an ambient temperature of 23°C and a humidity of 50% RH. The puncture needle used is made of polylactic acid and has a needle length of 1.5 mm, a tip diameter of 40 μm, and an apex angle of 11°. (Tensile test) A test specimen is prepared by cutting out a rectangular shape of 18 mm x 50 mm in plan view from the patch to be tested in its natural state. A tensile tester is used to pull the test piece in its longitudinal direction, and the relationship between the tensile load and the displacement of the test piece is determined. From this relationship, the maximum tensile load per unit width and the elongation at the maximum tensile load are determined. The distance between a pair of gripping jigs in the tensile tester is 30 mm, and the tensile load rate is 2 mm / min. The test environment is an ambient temperature of 23°C and a humidity of 50% RH.

4. The puncture-assisting patch according to claim 3, wherein when a graph is created based on the results of the tensile test, with the vertical axis representing the tensile load and the horizontal axis representing the displacement of the test piece, the maximum slope of the graph per unit width is 10 N / mm or more and 300 N / mm or less.

5. The puncture-assisting patch according to any one of claims 1 to 4, wherein an adhesive is disposed on the outer surface thereof, and the adhesive strength when attached to the surface of the simulated stratum corneum via the adhesive is 0.5 N / 10 mm or more and 16 N / 10 mm or less.

6. The puncture-assisting patch according to any one of claims 1 to 5, wherein a recessed portion having an opening is provided on at least the surface of the patch opposite to the skin-facing surface as a mark indicating the puncture position of the puncture needle.

7. A puncture-assisting patch as described in claim 6, wherein the circular equivalent diameter of the recessed portion is 2.5 μm or more and 2000 μm or less.

8. A puncture device kit comprising a puncture needle for puncturing the skin, and a patch separate from the puncture needle, which is attached to the site of the skin to be punctured and its surrounding area and is punctured together with the skin by the puncture needle, The puncture needle includes a microneedle having a needle length of 70 μm or more and 1020 μm or less, or a microneedle having a needle length of 310 μm or more and 1300 μm or less, The patch has an area of ​​20 mm square or more in a plan view, The thickness of the patch is 50 μm or more and 1000 μm or less, The thickness of the patch is thinner than the length of the puncture needle.

9. A puncture device kit as described in Claim 8, wherein the adhesive body exhibits a yield point in the puncture test described below, and the yield load is 0.7 N or more and 10 N or less, and the displacement of the puncture needle at the yield point is 0.1 mm or more and 2.2 mm or less. (Puncture test) A test piece was prepared by cutting a square piece measuring 20 mm on each side in a planar view from the patch to be tested in its natural state. A skin model consisting of a laminate of a simulated stratum corneum made of a 20 μm thick polyethylene film and a 5 mm thick simulated skin was used as the target for the test piece to be attached. A test piece was attached to the surface of the simulated stratum corneum, and a puncture needle was pressed into the test piece perpendicular to the surface of the simulated stratum corneum using a compression tester at a speed of 60 mm / min, and the relationship between the compression load and the displacement of the puncture needle was determined.The presence or absence of a yield point was determined from this relationship, and if there was a yield point, the yield load and the displacement of the puncture needle at the yield point were determined.The test environment was an ambient temperature of 23°C and a humidity of 50% RH. The puncture needle used is made of polylactic acid and has a needle length of 1.5 mm, a tip diameter of 40 μm, and an apex angle of 11°.

10. A puncture device kit as described in claim 8 or 9, wherein the microneedle contains resin.

11. A puncture device kit described in any one of claims 8 to 10, wherein the microneedle has a hollow portion.

Images