Detachable microneedle and method for manufacturing the same

Abstract

One embodiment of the present invention provides a separable micro-needle characterized by comprising: a base; and a plurality of micro-needles located on the base, each comprising a separation layer and a needle tip located on the separation layer.

Description

Technology Field

[0001] The present invention relates to microneedles, and more specifically, to a detachable microneedle capable of being separated after adhering to the skin, and a method for manufacturing the same. Background Technology

[0003] Microneedle patches are a technology utilized for delivering drugs through the skin or as diagnostic sensors, and they are attracting attention in the medical and cosmetic fields due to their non-invasive and highly efficient characteristics. However, conventional microneedle patches typically involve the entire structure being removed after adhesion to the skin, which leads to limitations in drug delivery time or makes it difficult to continuously perform specific functions. In particular, existing structures faced limitations when the needles needed to remain on the skin to sustain drug release for extended periods or perform specific internal functions.

[0004] Furthermore, conventional microneedle patches fail to separate the substrate from the needles, which can lead to drug delivery being hindered by external environmental factors (e.g., friction, moisture) while the substrate remains on the skin, or cause environmental issues related to substrate disposal after use. These problems have been particularly pronounced in fields requiring extended drug delivery times or precise control.

[0005] Therefore, there is a need for a new type of micro-needle that can solve existing problems while simultaneously enhancing biocompatibility and ease of operation. Prior art literature

[0007] Republic of Korea Registered Patent No. 10-2597477 The problem to be solved

[0008] The technical problem that the present invention aims to solve is to resolve the problems of the aforementioned prior art by providing a separable micro-needle capable of separating micro-needles and a method for manufacturing the same.

[0009] The technical problems that the present invention aims to solve are not limited to those mentioned above, and other unmentioned technical problems will be clearly understood by those skilled in the art to which the present invention belongs from the description below. means of solving the problem

[0011] To achieve the above technical problem, one embodiment of the present invention provides a separable micro needle.

[0012] In one embodiment of the present invention, the separable micro needle may include a base; and a plurality of arranged micro needles located on the base, each consisting of a separation layer and a needle tip located on the separation layer.

[0013] In addition, in one embodiment of the present invention, when near-infrared rays are irradiated onto the separation layer, the temperature of the separation layer rises due to a photothermal effect, so that the needle tips of the plurality of micro-needles can be separated from the base.

[0014] In addition, in one embodiment of the present invention, the separation layer may include MXene.

[0015] In addition, in one embodiment of the present invention, the thickness of the separation layer may be 5% to 90% of the total height of the micro needle.

[0016] In addition, in one embodiment of the present invention, the needle tip may further contain a drug.

[0017] In addition, in one embodiment of the present invention, the separable micro-needle may include a natural-derived polymer-based hydrogel, MXene, and a biocompatible material.

[0018] In addition, in one embodiment of the present invention, the natural polymer-based hydrogel may include one or more types from the group consisting of gelatin, collagen, and seaweed-based hydrogels.

[0019] In addition, in one embodiment of the present invention, the biocompatible material may include one or more materials from the group consisting of polylactic acid, polyglycolic acid, poly(lactide-co-glycolic acid), polycaprolactone, gelatin, collagen, fibroin fibers, alginate, and fucoidan.

[0020] In addition, in one embodiment of the present invention, the content of the natural-derived polymer-based hydrogel is 5% to 90% by weight relative to 100% by weight of the total separable micro needle, the content of the MXene is 5% to 30% by weight, and the remainder may include drugs, biocompatible materials and other inevitably added impurities.

[0021] To achieve the above technical problem, another embodiment of the present invention provides a method for manufacturing a separable micro needle.

[0022] In one embodiment of the present invention, a method for manufacturing a separable micro-needle may include the steps of: preparing a first mixed solution in which a natural-derived polymer-based hydrogel and a drug are mixed in a solvent, and a second mixed solution in which a biocompatible material and MXene are mixed in a solvent, respectively; applying and curing the first mixed solution on a mold having an intaglio formed corresponding to the shape of a micro-needle to form a needle tip; and applying and curing the second mixed solution on the mold having the needle tip formed to form a separation layer.

[0023] In addition, in one embodiment of the present invention, the content of the natural-derived polymer-based hydrogel is 5% to 90% by weight relative to 100% by weight of the total separable micro needle, the content of the MXene is 5% to 30% by weight, and the remainder may include drugs, biocompatible materials and other inevitably added impurities.

[0024] In addition, in one embodiment of the present invention, after the step of forming the separation layer, the method may further include the step of forming a base by curing an adhesive sheet or a photocurable polymer after application. Effects of the invention

[0026] A detachable microneedle according to one embodiment of the present invention has a needle tip portion of a microneedle containing a drug including a therapeutic agent separated by a separation layer, so that the needle tip can be separated and independently positioned inside the skin without the need to continuously attach a patch, thereby enabling the continuous injection of the drug into the human body and providing an effect that can secure differentiation from various conventional microneedle technologies.

[0027] The effects of the present invention are not limited to the effects described above, and should be understood to include all effects that can be inferred from the configuration of the invention described in the detailed description of the invention or the claims. Brief explanation of the drawing

[0029] FIG. 1 is a schematic diagram showing the structure of a separable micro-needle according to one embodiment of the present invention. FIG. 2 is a schematic diagram showing the appearance of separated micro-needles by applying a separable micro-needle according to one embodiment of the present invention. FIG. 3 is a schematic diagram showing the manufacturing process of a separation layer of a separation type micro needle according to one embodiment of the present invention. Specific details for implementing the invention

[0030] The present invention will be described below with reference to the attached drawings. However, the present invention may be implemented in various different forms and is therefore not limited to the embodiments described herein. Furthermore, in order to clearly explain the present invention in the drawings, parts unrelated to the explanation have been omitted, and similar parts throughout the specification have been given similar reference numerals.

[0031] Throughout the specification, when it is stated that a part is "connected (connected, in contact, combined)" with another part, this includes not only cases where they are "directly connected," but also cases where they are "indirectly connected" with other members interposed between them. Furthermore, when it is stated that a part "includes" a certain component, this means that, unless specifically stated otherwise, it does not exclude other components but rather allows for the inclusion of additional components.

[0032] The terms used herein are merely for describing specific embodiments and are not intended to limit the invention. Singular expressions include plural expressions unless the context clearly indicates otherwise. In this specification, terms such as “comprising” or “having” are intended to indicate the presence of the features, numbers, steps, actions, components, parts, or combinations thereof described in the specification, and should be understood as not precluding the existence or addition of one or more other features, numbers, steps, actions, components, parts, or combinations thereof.

[0033] Embodiments of the present invention will be described in detail below with reference to the attached drawings.

[0034] Although the use of conventional microneedles is increasing due to their ability to deliver drugs stably and with high efficiency, they have not been free from the problem of causing inconvenience because the microneedle patch must be worn during the drug delivery period, and the inability to deliver the desired drug if the patch falls off or detaches midway.

[0035] To solve these problems, the present invention provides a separable micro-needle capable of being separated within the skin and a method for manufacturing the same.

[0036] Hereinafter, the present invention will be described with reference to the drawings presented in this specification. For reference, the drawings may be partially exaggerated to illustrate the features of the present invention. In such cases, it is preferable to interpret them in light of the entire intent of this specification.

[0038] A separable micro-needle according to one embodiment of the present invention is described.

[0039] FIG. 1 is a schematic diagram showing the structure of a separable micro-needle according to one embodiment of the present invention.

[0040] Referring to FIG. 1, a separable micro needle according to one embodiment of the present invention may include a base (100); and a plurality of micro needles located on the base, each consisting of a separation layer (200) and a needle tip (300) located on the separation layer.

[0041] The above base is not particularly limited as long as it is of a type that is harmless to the human body, and as an example, it may include a biodegradable polymer.

[0042] Meanwhile, the plurality of micro-needles located on the base may be composed of two layers.

[0043] Specifically, it may consist of a separation layer and a needle tip portion, which can be seen in more detail through Fig. 1.

[0044] At this time, the micro-needles may be in the shape of a cone, for example.

[0045] At this time, the separable micro needle of the present invention has a base and a needle tip connected by a separation layer, so that the needle tip can be separated from the base after penetrating into the skin.

[0046] At this time, for the needle tip to be separated, it is important that the separation layer separates from the needle tip under specific conditions.

[0047] To this end, the above separation layer may generate a photothermal effect in which its temperature rises upon near-infrared irradiation.

[0048] At this time, specifically, when near-infrared rays are irradiated onto the separation layer, the temperature of the separation layer rises, and the needle tips of the plurality of micro-needles can be separated from the base.

[0049] Specifically, when the temperature of the separation layer rises, it melts the surrounding polymer, causing the needle tip to separate from the base; to achieve this, the present invention may mix MXene into the separation layer.

[0050] MXene exhibits a photothermal effect in which its temperature rises when exposed to near-infrared light; by characterizing MXenes that display this property, it is possible to induce a temperature increase and the melting of surrounding materials according to the ratio.

[0051] When MXene is mixed into the separation layer of a separable micro-needle using the aforementioned properties, when near-infrared irradiation occurs, the MXene mixed in the separation layer absorbs the light energy of the near-infrared rays, causing only the temperature of the MXene to rise locally. Consequently, the temperature of only the separation layer mixed with MXene rises selectively, melting the surrounding polymer layer, thereby allowing the needle tip to be separated from the base.

[0052] At this time, the aforementioned effect can be confirmed in detail by looking at Fig. 2.

[0053] FIG. 2 is a schematic diagram showing the appearance of separated micro-needles by applying a separable micro-needle according to one embodiment of the present invention.

[0054] Referring to Fig. 2, when near-infrared rays are irradiated onto the separation layer, the separation layer and the needle tip are separated from each other, and it can be confirmed that the needle tip remains continuously inside the human body. At this time, the needle tip may contain more drugs, allowing for continuous drug delivery.

[0055] Meanwhile, the above-mentioned separable micro-needles may include natural-derived polymer-based hydrogels, MXenes, and biocompatible materials.

[0056] In addition, the above-mentioned detachable micro-needles may further contain drugs.

[0057] At this time, the above drug may be any drug intended to be introduced into the body, and the state of the drug is not particularly limited.

[0058] At this time, the above drug may be contained inside the needle tip, may be mixed entirely into the needle tip, or may be present as a coating on the outside of the needle tip, but the method of inclusion is not particularly limited.

[0059] Meanwhile, the above natural-derived polymer-based hydrogel is not particularly limited, but preferably may include one or more types from the group consisting of gelatin, collagen, and seaweed-based hydrogels.

[0060] In addition, the above biocompatible material may include biodegradable materials that are biocompatible, and may include, for example, one or more from the group consisting of polylactic acid, polyglycolic acid, poly(lactide-co-glycolic acid), polycaprolactone, gelatin, collagen, fibroin fibers, alginate, and fucoidan.

[0061] Meanwhile, relative to 100% by weight of the total of the above-described separation type micro needle, the content of the natural-derived polymer-based hydrogel is 5% to 90% by weight, the content of the MXene is 5% to 30% by weight, and the remainder may include drugs, biocompatible materials and other inevitably added impurities.

[0062] This is because if the content of the MXene is less than 5% by weight relative to the total 100% by weight of the above-mentioned separated micro-needle, a problem may arise where the temperature does not rise, and if it exceeds 30% by weight, a problem may arise where it becomes difficult to manufacture the micro-needle and biocompatibility decreases.

[0063] Below, we intend to describe a method for manufacturing a separable micro-needle that achieves the aforementioned effects.

[0065] A method for manufacturing a separable micro-needle according to one embodiment of the present invention is described.

[0066] The method for manufacturing a separable micro-needle according to the present invention can apply all the details described above regarding the separable micro-needle, and although detailed descriptions of overlapping parts have been omitted, they can be applied in the same way even if such descriptions are omitted.

[0068] A method for manufacturing a separable micro-needle according to one embodiment of the present invention may include the steps of: preparing a first mixed solution in which a natural-derived polymer-based hydrogel and a drug are mixed in a solvent, and a second mixed solution in which a biocompatible material and MXene are mixed in a solvent, respectively; applying and curing the first mixed solution on a mold having an intaglio formed corresponding to the shape of a micro-needle to form a needle tip; and applying and curing the second mixed solution on the mold having the needle tip formed to form a separation layer.

[0070] The first step may include preparing a first mixed solution in which a natural-derived polymer-based hydrogel and a drug are mixed in a solvent, and a second mixed solution in which a biocompatible material and MXene are mixed in a solvent, respectively.

[0071] At this time, the solvent is not particularly limited, and distilled water may be used as an example.

[0072] At this time, the natural polymer-based hydrogel may include one or more types from the group consisting of gelatin, collagen, and seaweed-based hydrogels.

[0073] In addition, the above biocompatible material may include one or more materials from the group consisting of polylactic acid, polyglycolic acid, poly(lactide-co-glycolic acid), polycaprolactone, gelatin, collagen, fibroin fibers, alginate, and fucoidan.

[0075] A second step may include applying and curing the first mixed solution onto a mold having an intaglio formed thereon corresponding to the shape of a micro-needle to form a needle tip.

[0076] At this time, a needle tip can be formed by filling a portion of the mold with the first mixed solution.

[0077] At this time, although there are no specific restrictions on the molding process, preferably, a vacuum reduction method or a pressure filling method may be used.

[0078] At this time, the curing conditions are not particularly limited, and, for example, heat may be applied.

[0080] A third step may include applying and curing the second mixed solution onto the mold on which the needle tip is formed to form a separation layer.

[0081] At this time, the second mixed solution can be applied onto the mold on which the needle tip is formed to completely fill the indentation of the mold.

[0082] At this time, although not specifically limited during the molding process, preferably, a vacuum reduction method or a pressure filling method may be used.

[0083] At this time, the second mixed solution may overflow out of the intaglio.

[0084] Therefore, the process of filling the engraved structure on the mold with the slide glass fixed using hand pressure and scraping off the overflowing solution can be further carried out.

[0085] Meanwhile, the curing conditions for forming the separation layer are not particularly limited.

[0086] Meanwhile, after the step of forming the separation layer, the method may further include the step of forming a base by applying and curing an adhesive sheet or a photocurable polymer.

[0087] In this case, an adhesive hydrocolloid sheet can be used.

[0089] The present invention will be explained in more detail below through examples and experimental examples. These examples and experimental examples are solely for the purpose of illustrating the present invention, and the scope of the present invention is not limited by these examples and experimental examples.

[0091] Example: Manufacturing of Separable Micro Needles

[0092] FIG. 3 is a schematic diagram of a primary biomaterial molded according to one embodiment of the present invention.

[0093] Referring to Figure 3, first, to prepare the first mixed solution, 7g of seaweed-based hydrogel and 2g of a drug such as an analgesic were mixed with 10g of distilled water.

[0094] The mixture was stirred for 30 minutes to prepare a homogeneous first mixed solution.

[0095] In addition, to prepare the second mixed solution, 3g of collagen and 2g of MXene were mixed with 10g of distilled water.

[0096] At this time, the mixture was ultrasonically treated for 1 hour to prepare a uniform second mixed solution.

[0097] Afterwards, to form a micro needle tip, the previously prepared first mixed solution was first molded onto a mold with an intaglio formed thereon, and heat curing was performed for 1 hour to manufacture the micro needle tip.

[0098] After that, a second mixed solution of biocompatible material and MXene was molded.

[0099] At this time, for the molding process, a vacuum was applied after the solution was applied so that the solution filled the empty space.

[0100] Next, the engraved structure on the PDMS mold was filled with a slide glass held in place by hand pressure, and the overflowing solution was scraped away.

[0101] After that, heat curing was performed for 30 minutes to produce a separation layer.

[0102] Finally, a separable micro-needle was manufactured by placing an adhesive hydrocolloid sheet on the separation layer.

[0104] Experimental Example

[0105] The separation type micro-needles fabricated as in the above example were irradiated with near-infrared light to verify whether the separation layer containing MXene was effectively separated.

[0106] It can be confirmed that separation can be effectively achieved depending on the combination, concentration, and drying method of the separation layer containing MXene, and that the degree of separation varies depending on the concentration of MXene.

[0107] Generally, when the amount of MXene is maximized under conditions where separation layer fabrication is possible, it can be confirmed that the ambient temperature rises rapidly upon near-infrared irradiation, enabling effective separation.

[0109] The foregoing description of the present invention is for illustrative purposes only, and those skilled in the art will understand that other specific forms can be easily modified without altering the technical spirit or essential features of the present invention. Therefore, the embodiments described above should be understood as illustrative in all respects and not restrictive. For example, each component described as a single unit may be implemented in a distributed manner, and components described as distributed may likewise be implemented in a combined form.

[0110] The scope of the present invention is defined by the claims set forth below, and all modifications or variations derived from the meaning and scope of the claims and equivalent concepts thereof should be interpreted as being included within the scope of the present invention.

Claims

Claim 1 A separable micro-needle characterized by comprising: a base; and a plurality of micro-needles located on the base, each comprising a separation layer and a needle tip located on the separation layer. Claim 2 A separable micro-needle according to claim 2, characterized in that when near-infrared rays are irradiated onto the separating layer, the temperature of the separating layer rises due to a photothermal effect, causing the needle tips of the plurality of micro-needles to separate from the base. Claim 3 A separation type microneedle according to claim 2, characterized in that the separation layer comprises MXene. Claim 4 A separated microneedle according to claim 2, characterized in that the thickness of the separation layer is 5% to 90% of the total height of the microneedle. Claim 5 In claim 1, the detachable micro needle is characterized in that the needle tip further contains a drug. Claim 6 In claim 1, the detachable micro-needle is characterized by comprising a naturally derived polymer-based hydrogel, MXene, and a biocompatible material. Claim 7 A separation type microneedle according to claim 6, characterized in that the natural-derived polymer-based hydrogel comprises one or more types from the group consisting of gelatin, collagen, and seaweed-based hydrogels. Claim 8 A separable microneedle according to claim 6, characterized in that the biocompatible material comprises one or more types selected from the group consisting of polylactic acid, polyglycolic acid, poly(lactide-co-glycolic acid), polycaprolactone, gelatin, collagen, fibroin fibers, alginate, and fucoidan. Claim 9 A separated microneedle according to claim 6, characterized in that, relative to 100% by weight of the total separated microneedle, the content of the natural-derived polymer-based hydrogel is 5% to 90% by weight, the content of the MXene is 5% to 30% by weight, and the remainder comprises drugs, biocompatible materials and other inevitably added impurities. Claim 10 A method for manufacturing a separable microneedle, characterized by comprising: a step of preparing a first mixed solution in which a natural-derived polymer-based hydrogel and a drug are mixed in a solvent, and a second mixed solution in which a biocompatible material and MXene are mixed in a solvent; a step of forming a needle tip by applying and curing the first mixed solution on a mold having an intaglio formed corresponding to the shape of a microneedle; and a step of forming a separation layer by applying and curing the second mixed solution on the mold having the needle tip formed thereon. Claim 11 A method for manufacturing a separated micro-needle according to claim 10, characterized in that, relative to 100% by weight of the total separated micro-needle, the content of the natural-derived polymer-based hydrogel is 5% to 90% by weight, the content of the MXene is 5% to 30% by weight, and the remainder comprises drugs, biocompatible materials and other inevitably added impurities. Claim 12 A method for manufacturing a separable micro-needle according to claim 10, further comprising the step of forming a base by curing an adhesive sheet or a photocurable polymer after the step of forming the separation layer.

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