Skin adhesive patch for negative pressure stimulation and method of manufacturing same

Abstract

One embodiment of the present invention provides a skin adhesive patch for negative pressure stimulation, which has an adhesive structure that mimics the octopus's suction cup with a carved shape that can be stably attached and detached even in dry or moist skin environments, and has an adhesive cup portion with a deformable curvature so that the adhesive cup covers a wider area when attached to the skin, and which induces negative pressure locally on the skin when attached to the skin, thereby improving the delivery efficiency of active ingredients through the skin without using an external power source, and a method for manufacturing the same.

Description

[Technical Field]

[0001] The present invention relates to a skin adhesive patch, and more particularly to a skin adhesive patch for negative pressure stimulation that induces negative pressure locally to improve the delivery efficiency of an active ingredient through the skin without using an external power source, and a method for manufacturing the same. [Background technology]

[0002] With the rapid growth of the transdermal drug delivery system market, the development of manufacturing technologies for adhesive patches based on microstructures that can adhere to the skin without irritating it, and systems that can induce localized negative pressure on the skin without using an external power source, have great potential for application in medical wearable devices and therapeutic drug delivery patches.

[0003] In recent years, with the technological advancement of wearable drug delivery systems, transdermal drug delivery devices that can deliver drugs by adhering to the skin have attracted much attention.

[0004] Transdermal drug delivery is a system that delivers drugs into the body through skin absorption and is applicable to a variety of drugs and diseases.

[0005] Transdermal drug delivery systems have fewer side effects than oral administration methods, can improve bioavailability because they do not require hepatic metabolism, and are simpler than injection administration methods, which can improve patient compliance and convenience.

[0006] However, to achieve effective transdermal drug delivery, it is necessary to overcome the mechanical defense of the stratum corneum, which is the main barrier to transdermal delivery, and improve the delivery and absorption rates of drugs.

[0007] For this reason, drug delivery devices that have been commercially available to date have been developed using techniques such as inducing physical perforation of the stratum corneum using electrical stimulation, invasive drug delivery using fine needles, drug delivery using photothermal stimulation, and chemical enhancer technology to improve delivery rates.

[0008] One example of transdermal drug delivery technology is a method that uses strong magnetic pressure to induce microscopic perforations in the skin layer, thereby improving drug delivery efficiency. However, there is a problem with this method, as the strong pressure required to induce perforations can lead to skin irritation. Furthermore, applying sufficient pressure requires wearing a magnet for a long period of time, making it difficult to put into practical use.

[0009] Another example of transdermal drug delivery technology is a method that uses the photothermal effect of near-infrared light to induce partial etching of the skin layer. This method has shown higher drug delivery efficiency than the use of chemical enhancers. However, drug delivery using photothermal stimulation has the problem of causing skin damage due to the removal of the stratum corneum, which can lead to secondary side effects.

[0010] Another example of a transdermal drug delivery technique is a method in which a suction cup is used to induce pressure after the drug is injected to improve drug delivery efficiency. In this case, a vacuum pump is required to induce pressure, which increases the complexity of use due to the additional use of the vacuum pump and requires the application of negative pressure for a long period of time.

[0011] Another example of transdermal drug delivery technology is a patch-type transdermal drug delivery product, which includes a drug layer and an adhesive layer, and many adhesive layers use chemical adhesive materials, which can leave residue on the skin or cause irritation.

[0012] That is, the transdermal drug delivery technology still has the following problems.

[0013] First, electrical stimulation requires an external power source. Second, electrical stimulation can cause secondary skin damage. Third, invasive methods using fine needles pose a risk of bacterial infection. Fourth, the use of chemical adhesive materials to achieve intimate contact between the drug delivery material and the skin interface can lead to side effects such as skin rash, peeling, and redness.

[0014] In other words, conventional technologies for improving transdermal drug delivery efficiency have technical and material limitations, and have problems such as concerns about skin damage, the need for an external power source, and the inability to ensure sufficient performance and stability in terms of adhesion to the skin.

[0015] Therefore, there is a need for technological developments that can solve the above-mentioned problems inherent in conventional techniques for transdermal drug delivery. [Prior art documents] [Patent documents]

[0016] [Patent Document 1] Korean Patent No. 10-2018-0065848 (Published June 18, 2018) Summary of the Invention [Problem to be solved by the invention]

[0017] In order to solve the above-mentioned problems of the prior art, the problem that the present invention aims to solve is to provide a skin adhesive patch for negative pressure stimulation that induces negative pressure locally and improves the delivery efficiency of active ingredients through the skin without using an external power source, and a method for manufacturing the same.

[0018] Another problem to be solved by the present invention is to provide a skin adhesive patch for negative pressure stimulation, which has an adhesive structure that mimics the embossed octopus suction cups and can be stably attached and detached even in dry or moist skin environments, and has an adhesive cup portion with a deformable curvature so that the adhesive cup covers a wider area when attached to the skin, and a method for manufacturing the same.

[0019] Another problem to be solved by the present invention is to provide a skin adhesive patch for negative pressure stimulation that minimizes skin irritation and side effects caused by transdermal drug delivery materials, and a method for manufacturing the same.

[0020] Another problem to be solved by the present invention is to provide a skin adhesive patch for negative pressure stimulation, which has stable skin adhesive performance and induces local negative pressure through an adhesive cup, thereby providing improved drug delivery efficiency, and a method for manufacturing the same.

[0021] The technical problems that the present invention aims to solve are not limited to the technical problems described above, and other technical problems not mentioned will be clearly understood by those skilled in the art to which the present invention pertains from the following description. [Means for solving the problem]

[0022] In order to achieve the above technical objective, one embodiment of the present invention provides a skin adhesive patch for negative pressure stimulation, characterized by comprising a flexible base portion 10 and a plurality of adhesive cup portions 20 arranged on the skin adhesive surface of the base portion 10.

[0023] The base portion 10 and the adhesive cup portion 20 may be made of one or more flexible polymer materials selected from the group consisting of PDMS (Polydimethylsiloxane), Ecoflex, PU (Polyurethane), PANI (Polyaniline), and SEBS (Styrene Ethylene / Butylene Styrene).

[0024] The adhesive cup portion 20 may include a cup pillar portion 21 having a negative pressure groove 22 formed on its skin-adhesive surface, an adhesive flange portion 23 extending from the upper edge region of the negative pressure groove 22 to the side surface of the cup pillar portion 21, and a dome portion 25 protruding from the bottom surface of the negative pressure groove 22 by embossing.

[0025] The cup pillar 21 may have a curved column shape with its side surface being curved in the vertical central axis direction of the cup pillar 21 .

[0026] The adhesive cup portion 20 may further include a polymer precursor coating layer 50 formed on the upper surface of the adhesive flange portion 23 to smooth the surface roughness and improve adhesive strength.

[0027] The polymer precursor forming the polymer precursor coating layer 50 may include one or more selected from the group consisting of PDMS (Polydimethylsiloxane), Ecoflex, PU (Polyurethane), PANI (Polyaniline), and SEBS (Styrene Ethylene / Butylene Styrene).

[0028] In order to achieve the above technical objectives, another embodiment of the present invention may include a 3D mold model design step of designing a 3D mold model having engraved shapes corresponding to the plurality of adhesive cup portions 20 to manufacture a skin adhesive patch for skin negative pressure stimulation, a 3D mold fabrication step of fabricating a 3D mold 30 according to the 3D mold model design, a molding step of depositing a flexible polymer material on the surface-treated 3D mold 30 and then curing it to form a skin adhesive patch 1 having a base surface portion 10 and the plurality of adhesive cup portions 20, an injection step of separating the molded skin adhesive patch 1 from the 3D mold 30, and a polymer precursor coating layer formation step of forming a polymer precursor coating layer 50 on the skin adhesive surface of the skin adhesive patch 1.

[0029] The step of fabricating the 3D mold may further include a step of surface treating the 3D mold.

[0030] The molding step may be performed by a solution process using a flexible polymer material.

[0031] In the molding step, the flexible polymer material may be at least one selected from the group consisting of PDMS (Polydimethylsiloxane), Ecoflex, PU (Polyurethane), PANI (Polyaniline), and SEBS (Styrene Ethylene / Butylene Styrene).

[0032] The polymer precursor coating layer forming step may be a stamping process step in which a polymer precursor is laminated on the skin adhesive surface of the skin adhesive patch 1, and then a stamping process is performed to form the polymer precursor coating layer 50 and the adhesive flange portion 23.

[0033] The polymer precursor coating layer forming step may be a spray coating step of spraying a polymer precursor onto the skin adhesive surface of the skin adhesive patch 1 to form the polymer precursor coating layer 50 .

[0034] In the polymer precursor coating layer formation step, the polymer precursor may include at least one selected from the group consisting of PDMS (Polydimethylsiloxane), Ecoflex, PU (Polyurethane), PANI (Polyaniline), and SEBS (Styrene Ethylene / Butylene Styrene). [Effects of the Invention]

[0035] The above-described embodiment of the present invention has the effect of solving problems such as a drug delivery system that requires an external power source, the use of structures and materials that may induce secondary diseases such as skin infection, rash, and redness, and adhesive properties that ensure stable adhesion to the skin.

[0036] Furthermore, the above-described embodiment of the present invention has the effect of improving the delivery efficiency of active ingredients through the skin by locally inducing negative pressure without using an external power source.

[0037] In addition, the above-mentioned embodiment of the present invention has an adhesive structure that mimics the embossed octopus suction cups, which can be stably attached and detached even in dry or moist skin environments, and has a deformable curvature that allows the adhesive cups to cover a wider area when attached to the skin, thereby having the effect of softening the skin keratin and improving drug absorption capacity.

[0038] Furthermore, the above-described embodiment of the present invention has the effect of enabling negative pressure stimulation that minimizes skin irritation and side effects caused by transdermal drug delivery materials.

[0039] In addition, the above-described embodiment of the present invention has the effect of providing the basic technology for high-performance medical patch systems such as drug delivery systems and skin interface sensors by combining conventional transdermal drug delivery technology with various delivery components or electronic materials.

[0040] The effects of the present invention are not limited to the effects described above, but should be understood to include all effects that can be inferred from the configuration of the invention described in the detailed description of the present invention or the claims. [Brief explanation of the drawings]

[0041] [Figure 1] 1 is a perspective view of a skin adhesive patch 1 for negative pressure stimulation according to one embodiment of the present invention, and a partial cross-sectional view showing an enlarged adhesive cup portion 20.

[0032] FIG. [Figure 2]Photographs, cross-sections, and design drawings of a large-area patch showing the structure of a embossed octopus-mimicking adhesive cup that includes a micro-dome structure and curved surfaces. [Figure 3] 1A-1D are schematic diagrams illustrating steps for manufacturing an adhesive patch according to one embodiment of the present invention. [Figure 4] 1 is a graph showing normal adhesive force measurement data according to the scale (diameter: 2, 3, 5, 10 mm) of the adhesive structure in a dry environment and an environment where moisture is present. [Figure 5] 1A is a photograph showing the increase in area of ​​the adhesive cup portion 20 when preloaded, and FIG. 1B is a graph showing the coverage ratio of the area that can be covered by the adhesive cup portion 20 depending on the outer diameter of the skin contact surface of the adhesive cup portion 20 (outer diameter of the skin contact surface of the adhesive cup portion 20: (i) 2 mm, (ii) 3 mm, (iii) 5 mm, (iv) 10 mm). [Figure 6] Figure 1 shows the adhesive performance of the patch on a pig skin replica. (a) Vertical adhesive performance as a function of preload, (b) Horizontal and peel adhesive performance of the octopus-mimicking adhesive structure (d-SCC) and the patch without the structure (flat), and (c) Graph showing adhesive performance of d-SCC after 100 repetitions. [Figure 7] (a) Schematic diagram of the cases with and without d-SCC application, (b) measurement data of the delivery depth of fluorescent particles (rhodamine b) on pig skin according to the application time of the d-SCC (5, 10, 20, 30 minutes) in each case, and (c) photographs showing the state of fluorescent particles (rhodamine b) delivered to the skin according to the application time of the d-SCC (5, 10, 20, 30 minutes). [Figure 8] (a) Schematic diagram of the case where the d-SCC is removed, (b) Measurement data of the delivery depth of fluorescent particles (rhodamine b) according to the time (5, 10, 20, 30 minutes) after the d-SCC is applied to pig skin for 30 minutes and then removed, and (c) Photographs showing the state of delivery of fluorescent particles (rhodamine b) according to the time (5, 10, 20, 30 minutes) after the d-SCC is applied to pig skin for 30 minutes and then removed. [Figure 9]1 is a graph showing data measuring the delivery depth of fluorescent particles enhanced by d-SCC in various skin types (pig skin, human skin, artificial skin). [Figure 10] This is an image showing the degree of deformation of the stratum corneum of skin (pig) in response to pre-load. [Figure 11] (a) A graph showing the degree of improvement in delivery depth by d-SCC for various drugs with different molecular weights on pig skin, and (b) photographs showing the delivery status of various drugs under each of the above conditions. [Figure 12] (a) Photographs of the application of commercially available products (surgical plastic tape, chlorhexidine gluconate film) and a d-SCC patch according to one embodiment of the present invention to multiple human skin samples, and a graph comparing the degree of skin irritation when the commercially available products and a d-SCC patch according to one embodiment of the present invention are applied. [Figure 13] (a) Photographs showing the skin recovery process of mice with atopic dermatitis after application of multiple drugs and d-SCC, and (b) a graph showing the transepidermal water loss over time when the multiple drugs and d-SCC were applied together. DETAILED DESCRIPTION OF THE INVENTION

[0042] The present invention will be described below with reference to the accompanying drawings. However, the present invention may be embodied in various different forms and is not limited to the embodiments described herein. In addition, in the drawings, parts that are not relevant to the description are omitted in order to clearly explain the present invention, and similar parts are designated by similar reference numerals throughout the specification.

[0043] Throughout this specification, when a part is described as being "connected (connected, contacted, or coupled)" to another part, this includes not only "directly connected" but also "indirectly connected" via other members therebetween. Furthermore, when a part is described as "comprising" a certain component, this does not exclude other components, but means that it may further comprise other components, unless otherwise specified.

[0044] The terms used in this specification are merely used to describe specific embodiments and are not intended to limit the present invention. The singular expressions include the plural expressions unless the context clearly dictates otherwise. In this specification, the terms "comprise" and "have" specify the presence of a feature, value, step, operation, component, part, or combination thereof described in the specification, and should be understood not to preclude the possibility of the presence or addition of one or more other features, value, step, operation, component, part, or combination thereof.

[0045] Hereinafter, embodiments of the present invention will be described in detail with reference to the accompanying drawings.

[0046] FIG. 1 is a perspective view of a skin adhesive patch 1 for negative pressure stimulation according to one embodiment of the present invention, and a partially enlarged cross-sectional view of an adhesive cup portion 20. FIG.

[0047] As shown in FIG. 1, the skin adhesive patch 1 may include a flexible base portion 10 and a plurality of adhesive cup portions 20.

[0048] Figure 2 shows a photograph, cross section, and design drawing of a large-area patch showing the structure of an octopus-mimicking adhesive cup with a embossed shape including a micro-dome structure and curved surfaces.

[0049] The adhesive cup has a micro-dome structure, which maximizes the volume change inside the cup and utilizes negative pressure to adhere to the surface.

[0050] Referring to FIG. 2(a), an actual photograph of a large area patch is shown.

[0051] Referring to Figures 2(b) and 2(c), cross-sectional views and design drawings of an actual octopus sticky cup and the sticky cup structure are shown.

[0052] Referring to FIG. 2(d), the mechanism of the adhesive structure is shown.

[0053] The base surface portion 10 can be made to be flexible.

[0054] The adhesive cup portions 20 may be arranged in a plurality on the skin-adhering surface of the base portion 10 .

[0055] The base portion 10 and the adhesive cup portion 20 may be made of one or more flexible polymer materials selected from the group consisting of PDMS (Polydimethylsiloxane), Ecoflex, PU (Polyurethane), PANI (Polyaniline), and SEBS (Styrene Ethylene / Butylene Styrene).

[0056] The adhesive cup portion 20 may include a cup pillar portion 21 , an adhesive flange portion 23 and a fine dome portion 25 .

[0057] The cup pillar 21 may have a side surface having a curved column shape, with the side generatrix being formed in an arc shape curved in the vertical central axis direction of the cup pillar 21 .

[0058] The cup pillar 21 may have a negative pressure groove 22 formed on the skin-adhering surface.

[0059] The adhesive flange 23 may be formed to extend from the upper edge region of the negative pressure groove 22 to the side surface of the cup pillar 21, and may be configured to increase adhesive strength by widening the adhesive surface that comes into contact with the skin.

[0060] The dome portion 25 may be formed by protruding from the bottom surface of the negative pressure groove 22. The dome portion 25 maintains a uniform air volume distribution inside the negative pressure groove 22. As a result, when the skin adhesive patch 1 of the present embodiment adheres to the skin, the air volume for providing adhesive force inside the negative pressure groove 22 is made uniform, and the negative pressure distribution is made uniform, thereby improving adhesive force.

[0061] The adhesive cup portion 20 may further include a polymer precursor coating layer 50 formed on the upper surface of the adhesive flange portion 23 to smooth the surface roughness and improve adhesive strength.

[0062] The outer diameter of the skin-adhering surface of the adhesive cup part 20 may be 2 mm to 10 mm. In this case, in order to efficiently increase the coverage area ratio of the adhesive cup part 20, the outer diameter of the skin-adhering surface of the adhesive cup part 20 is preferably 2 mm to 5 mm. More preferably, the outer diameter of the skin-adhering surface of the adhesive cup part 20 may be 2 mm to 3 mm.

[0063] The polymer precursor forming the polymer precursor coating layer 50 may include one or more selected from the group consisting of PDMS (Polydimethylsiloxane), Ecoflex, PU (Polyurethane), PANI (Polyaniline), and SEBS (Styrene Ethylene / Butylene Styrene).

[0064] The skin adhesive patch 1 of one embodiment of the present invention having the above-mentioned configuration provides van der Waals force and negative pressure effects in dry environments, and capillary force and negative pressure effects in wet environments, due to the structure of the adhesive cup portion 20.

[0065] As a result, the skin adhesive patch 1 adheres to the skin and maintains a vacuum state at the localized area where the negative pressure grooves 22 are formed. This applies a negative pressure stimulus to the skin, stimulating the stratum corneum. This improves the delivery efficiency of various substances, including drugs, through the skin in a non-invasive manner. Furthermore, the skin adhesive patch 1 according to the present invention can be applied to various types of drugs as a high-performance therapeutic patch by improving substance delivery efficiency using negative pressure.

[0066] A method for manufacturing a skin adhesive patch for skin negative pressure stimulation according to one embodiment of the present invention may include a 3D mold model design step, a 3D mold manufacturing step, a molding step, an injection step, and a polymer precursor coating layer formation step.

[0067] The 3D mold model design step may be a step of designing a 3D mold model having intaglio shapes corresponding to the plurality of adhesive cup portions 20 in order to form a skin adhesive patch for skin negative pressure stimulation.

[0068] The 3D mold fabrication step may be a step of fabricating a 3D mold 30 for injection molding of the skin adhesive patch 1 according to the 3D mold model design.

[0069] The step of fabricating the 3D mold may further include a step of surface treating the 3D mold.

[0070] The surface treatment of the mold may be performed to mold a flexible polymer material using the 3D mold as a mold. Specifically, the surface treatment may be performed by placing the 3D mold in a solution capable of forming a monolayer, which may facilitate the separation of the flexible polymer material from the 3D mold.

[0071] The molding step may be a step of depositing a flexible polymer material onto the surface-treated 3D mold 30 and then curing it to form a skin adhesive patch 1 having a base portion 10 and a plurality of adhesive cup portions 20.

[0072] The molding step may be performed by a solution process in which a flexible polymer material is dissolved using an organic solvent, and then the solution is deposited on the 3D mold 30 using a method such as spin coating or inkjet printing.

[0073] In the molding step, the flexible polymer may be at least one selected from the group consisting of PDMS (Polydimethylsiloxane), Ecoflex, PU (Polyurethane), PANI (Polyaniline), and SEBS (Styrene Ethylene / Butylene Styrene).

[0074] The ejection step may be a step of separating the molded skin adhesive patch 1 from the 3D mold 30.

[0075] The polymer precursor coating layer forming step may be a stamping process step in which a polymer precursor is laminated on the skin adhesive surface of the skin adhesive patch 1, and then a stamping process is performed to form the polymer precursor coating layer 50 and the adhesive flange portion 23.

[0076] Alternatively, the polymer precursor coating layer forming step may be a spray coating step in which the polymer precursor is sprayed onto the skin adhesive surface of the skin adhesive patch 1 to form the polymer precursor coating layer 50 .

[0077] The step of forming the polymer precursor coating layer may further include a step of thinly laminating the polymer precursor by stamping or spray coating, and then thermally curing the polymer precursor.

[0078] FIG. 3 is a schematic diagram illustrating the steps for manufacturing an adhesive patch according to one embodiment of the present invention.

[0079] Referring to FIG. 3, the manufacturing process of an adhesive patch according to one embodiment of the present invention is shown to be carried out through the steps of pretreating a master mold, fabricated by 3D printing or the like, for the molding process, molding the patch through a molding process using a flexible polymer, and forming a flexible adhesive surface by polymer precursor coating.

[0080] The polymer precursor coating layer 50 increases the surface roughness of the adhesive flange portion 23 of the adhesive cup portion 20, thereby improving skin adhesion and minimizing skin irritation.

[0081] In addition, the adhesive flange portion 23 increases the skin adhesive area, thereby improving adhesive strength.

[0082] In the polymer precursor coating layer formation step, the polymer precursor may include at least one selected from the group consisting of PDMS (Polydimethylsiloxane), Ecoflex, PU (Polyurethane), PANI (Polyaniline), and SEBS (Styrene Ethylene / Butylene Styrene).

[0083] FIG. 4 is a graph showing normal adhesive force measurement data according to the scale (diameter: 2, 3, 5, 10 mm) of the adhesive structure in a dry environment and in an environment where moisture is present.

[0084] Referring to Figure 4, 1N / cm 2 It can be seen that when a preload of 1 mm is applied, the adhesive structure imitating an octopus sucker with a diameter of 3 mm exhibits the highest normal adhesive strength.

[0085] At this time, 1N / cm 2 The preload is a level of pressure that does not put strain on the skin.

[0086] FIG. 5 shows the relationship between the outer diameter of the skin contact surface of the adhesive cup portion 20 and the preload (N / cm 21) is a photograph showing the increase in the area of ​​the adhesive cup portion 20 when the adhesive cup portion 20 is placed in the adhesive cup 20; and (b) a graph showing the coverage ratio of the area that can be covered by the adhesive cup portion 20 when the adhesive cup portion has an outer diameter of (i) 2 mm, (ii) 3 mm, (iii) 5 mm, or (iv) 10 mm.

[0087] The pre-pressure means the force applied to adhere the skin adhesive patch 1 to the skin.

[0088] Referring to Figure 5, when a skin adhesive patch 1 having an adhesive cup portion 20 with an outer diameter of the skin adhesive surface of (i) 2 mm, (ii) 3 mm, (iii) 5 mm, or (iv) 10 mm is adhered to the skin and a pre-pressure is applied, it can be seen that the area of ​​the adhesive cup portion 20 increases.

[0089] At this time, the coverage ratio of the adhesive cup part 20 increased as the preload increased. Also, it was confirmed that the smaller the outer diameter of the skin contact surface of the adhesive cup part 20, the greater the coverage ratio of the adhesive cup part 20. Therefore, the outer diameter of the skin contact surface of the adhesive cup part 20 can be 2 mm to 10 mm.

[0090] In this case, in order to efficiently increase the coverage area ratio of the adhesive cup portion 20, the outer diameter of the skin-adhering surface of the adhesive cup portion 20 is preferably 2 mm to 5 mm.

[0091] More preferably, the outer diameter of the skin-adhering surface of the adhesive cup portion 20 may be 2 mm to 3 mm.

[0092] Figure 6 shows the adhesive performance of the patch on a pig skin replica. (a) Vertical adhesive performance as a function of preload, (b) Horizontal and peel adhesive performance of the octopus-mimicking adhesive structure (d-SCC) and the patch without structure (flat), and (c) Adhesive performance of d-SCC after 100 repetitions.

[0093] 6(a), it can be seen that in both the wet and dry states, the stronger the preload, which is the force applied to attach the skin adhesive patch 1 to the skin, the higher the vertical adhesive performance. It can also be seen that the vertical adhesive performance is higher in the wet state than in the dry state across all preload ranges.

[0094] Here, the dry environment refers to a general skin surface state where no liquid is present, and the wet environment refers to a state where the skin surface is sufficiently wet with liquid.

[0095] Generally, with conventional adhesives, moisture or liquids such as water lower the surface energy of the adhesive surface, making it more difficult to adhere. However, the adhesive cup of one embodiment of the present invention has the characteristic and advantage of improving adhesive performance to the skin surface in wet environments through suction sealing and capillary forces.

[0096] 6(b), it can be seen that the octopus-mimicking adhesive structure (d-SCC) according to one embodiment of the present invention has significantly better effects than a patch (flat) without the structure in terms of both horizontal and peel adhesion performance. It can also be seen that the octopus-mimicking adhesive structure (d-SCC) according to one embodiment of the present invention has better performance in the wet state than in the dry state.

[0097] Referring to FIG. 6(c), it can be seen that the adhesive performance of the octopus-mimicking adhesive structure (d-SCC) according to one embodiment of the present invention after 100 repetitions is superior in the wet state to the dry state in all regions.

[0098] Figure 7 shows (a) a schematic diagram of the cases with and without d-SCC application, (b) measurement data on the delivery depth of fluorescent particles (rhodamine b) on pig skin according to the application time of the d-SCC (5, 10, 20, and 30 minutes) in each case, and (c) photographs showing the state of fluorescent particles (rhodamine b) delivered to the skin according to the application time of the d-SCC (5, 10, 20, and 30 minutes).

[0099] Referring to FIG. 7, when the d-SCC was applied for 30 minutes, the delivery depth of the fluorescent particles (rhodamine b) was approximately 130 μm, which was the deepest.

[0100] Furthermore, when the d-SCC was applied for 30 minutes, the delivery depth of the fluorescent particles (rhodamine b) was confirmed to be increased by up to 44% compared to when the fluorescent particles were simply applied and delivered (w / o patch).

[0101] Figure 8 shows (a) a schematic diagram of the d-SCC after removal, (b) measurement data on the delivery depth of fluorescent particles (rhodamine b) according to the time (5, 10, 20, and 30 minutes) after the d-SCC was applied to pig skin for 30 minutes and then removed, and (c) photographs showing the delivery state of fluorescent particles (rhodamine b) according to the time (5, 10, 20, and 30 minutes) after the d-SCC was applied to pig skin for 30 minutes and then removed.

[0102] Referring to Figure 8, the d-SCC was applied for 30 minutes, and 30 minutes after its removal, the delivery depth of the fluorescent particles (rhodamine b) was confirmed to be the deepest, at approximately 150 μm or more.

[0103] Furthermore, after applying the d-SCC for 30 minutes and then removing it, 30 minutes later, the delivery depth of the fluorescent particles (rhodamine b) was confirmed to be up to 36% higher than when the fluorescent particles were simply applied and delivered (w / o patch).

[0104] FIG. 9 is a graph showing data measuring the delivery depth of fluorescent particles enhanced by d-SCC in various skin types (pig skin, human skin, and artificial skin).

[0105] Referring to FIG. 9(b),

[0106] In the case of pig skin, after applying a patch according to one embodiment of the present invention for 30 minutes, the delivery depth of fluorescent particles (rhodamine b) was improved by up to 44% compared to when fluorescent particles were simply applied and delivered (w / o patch),

[0107] Thirty minutes after removing the patch according to one embodiment of the present invention, it was confirmed that the delivery depth of the fluorescent particles (rhodamine b) was improved by up to 36% compared to when the fluorescent particles were simply applied and delivered (w / o patch).

[0108] In the case of human skin, after applying a patch according to one embodiment of the present invention for 30 minutes, the delivery depth of fluorescent particles (rhodamine b) was improved by up to 56% compared to when fluorescent particles were simply applied and delivered (w / o patch),

[0109] Thirty minutes after removing the patch according to one embodiment of the present invention, it was confirmed that the delivery depth of the fluorescent particles (rhodamine b) was improved by up to 31% compared to when the fluorescent particles were simply applied and delivered (w / o patch).

[0110] In the case of artificial skin, after applying a patch according to one embodiment of the present invention for 30 minutes, the delivery depth of fluorescent particles (rhodamine b) was improved by up to 138% compared to when fluorescent particles were simply applied and delivered (w / o patch).

[0111] Thirty minutes after removing the patch according to one embodiment of the present invention, it was confirmed that the delivery depth of the fluorescent particles (rhodamine b) was improved by up to 95% compared to when the fluorescent particles were simply applied and delivered (w / o patch).

[0112] Figure 10 is an image showing the degree of deformation of the stratum corneum of skin (pig) in response to preload.

[0113] 10, it can be seen that when a pre-pressure is applied and the patch is applied, the distance between the stratum corneum increases, resulting in deformation. It can also be seen that as the pre-pressure increases, a greater negative pressure is delivered to the skin, resulting in an increased degree of deformation of the stratum corneum. These results suggest that application of a patch can have a significant effect on the stratum corneum and improve the efficiency of substance delivery through the skin.

[0114] Figure 11 shows (a) a graph showing the degree of improvement in delivery depth by d-SCC for various drugs with different molecular weights on pig skin, and (b) photographs showing the delivery status of various drugs under each of the above conditions.

[0115] Referring to FIG. 11(a), it can be seen that the octopus-mimicking adhesive structure (d-SCC) according to one embodiment of the present invention has the best delivery depth when applied together with the drug Maltol.

[0116] When the octopus-mimicking adhesive structure (d-SCC) according to one embodiment of the present invention is applied together with the fat-soluble substance retinol and the water-soluble substances maltol, ramoplanin, hyaluronic acid, and ovalbumin, it has been confirmed that it has excellent delivery depth even for substances with various solubilities.

[0117] Figure 12 (a) shows photographs of the application of commercially available products (surgical plastic tape, chlorhexidine gluconate film) and a d-SCC patch according to one embodiment of the present invention to multiple human skin samples, and a graph comparing the degree of skin irritation when the commercially available products and a d-SCC patch according to one embodiment of the present invention were applied.

[0118] Figure 12 shows the results of evaluating the redness caused by irritation in terms of the intensity of RGB elements one minute after removal of several commercially available products and a patch according to one embodiment of the present invention. This shows that the d-SCC patch according to one embodiment of the present invention caused the least change in RGB elements compared to commercially available surgical plastic tape and chlorhexidine gluconate film. This means that the d-SCC patch according to one embodiment of the present invention caused the least irritation compared to commercially available surgical plastic tape and chlorhexidine gluconate film.

[0119] Figure 13 shows (a) photographs showing the progress of skin recovery in mice with atopic dermatitis after application of multiple drugs and d-SCC, and (b) a graph showing the rate of transepidermal water loss over time when the multiple drugs and d-SCC were applied together.

[0120] Referring to Figure 13, it can be seen that when maltol, a drug for treating atopic dermatitis, and a d-SCC patch according to one embodiment of the present invention were applied together, the transepidermal water loss (TEWL) was restored to a level closest to that of normal skin (control).

[0121] The above description of the present invention is for illustrative purposes only, and those skilled in the art will appreciate that the present invention can be easily modified into other specific forms without changing the technical spirit or essential features of the present invention. Therefore, the above-described embodiments are illustrative in all respects and should not be construed as limiting. For example, components described as a single form may be implemented in a distributed form, and similarly, components described as a distributed form may be implemented in a combined form.

[0122] The scope of the present invention is defined by the claims that follow, and all modifications and variations that fall within the meaning and scope of the claims and their equivalents should be construed as being included within the scope of the present invention. [Explanation of symbols]

[0123] 1 skin adhesive patch 10 Basal part 20 Adhesive cup part 21 Cup pillar 22 Negative pressure groove 23 Adhesive flange 25 Dome section 30 3D molds 40 Flexible polymer material 50 Polymer precursor coating layer

Claims

1. a flexible base portion (10); A skin adhesive patch for negative pressure stimulation, characterized in that it comprises a plurality of adhesive cup portions (20) arranged on the skin adhesive surface of the base surface portion (10).

2. The base surface portion (10) and the adhesive cup portion (20) are 10. The skin adhesive patch for negative pressure stimulation according to claim 1, which is made of one or more flexible polymer materials selected from the group consisting of PDMS (Polydimethylsiloxane), Ecoflex, PU (Polyurethane), PANI (Polyaniline), and SEBS (Styrene Ethylene / Butylene Styrene).

3. The adhesive cup portion (20) a cup pillar portion (21) having a negative pressure groove (22) formed on the skin-adhering surface; an adhesive flange portion (23) extending from an upper edge region of the negative pressure groove (22) to a side surface of the cup pillar portion (21); 2. The skin adhesive patch for negative pressure stimulation according to claim 1, characterized in that it comprises a dome portion (25) formed by embossing and protruding from the bottom surface of the negative pressure groove (22).

4. The cup pillar portion (21) is 4. The skin adhesive patch for negative pressure stimulation according to claim 3, wherein the side generatrices are formed in an arc shape curved in the vertical central axis direction of the cup pillar portion (21) so that the side has a curved pillar shape.

5. The adhesive cup portion (20) The skin adhesive patch for negative pressure stimulation according to claim 3, further comprising a polymer precursor coating layer (50) formed on the upper surface of the adhesive flange portion (23) to smooth surface roughness and improve adhesive strength.

6. The polymer precursor forming the polymer precursor coating layer (50) is 6. The skin adhesive patch for negative pressure stimulation according to claim 5, comprising at least one material selected from the group consisting of PDMS (Polydimethylsiloxane), Ecoflex, PU (Polyurethane), PANI (Polyaniline), and SEBS (Styrene Ethylene / Butylene Styrene).

7. 2. The method for producing a skin adhesive patch (1) for negative pressure stimulation according to claim 1, a 3D mold model design step of designing a 3D mold model having intaglio shapes corresponding to the plurality of adhesive cup portions (20); a 3D mold manufacturing step of manufacturing a 3D mold (30) according to the 3D mold model design; a molding step of depositing a flexible polymer material on the fabricated 3D mold (30) and then hardening the material to form a skin adhesive patch (1) having a base portion (10) and a plurality of adhesive cup portions (20); an injection step of separating the molded skin adhesive patch (1) from the 3D mold (30); A method for manufacturing a skin adhesive patch for negative pressure stimulation, comprising a polymer precursor coating layer forming step of forming a polymer precursor coating layer (50) on the skin adhesive surface of the skin adhesive patch (1).

8. The 3D mold manufacturing step includes: The method for manufacturing a skin adhesive patch for negative pressure stimulation according to claim 7, further comprising the step of surface treating the 3D mold.

9. The forming step comprises: The method for manufacturing a skin adhesive patch for negative pressure stimulation according to claim 7, wherein the method is carried out by a solution process using the flexible polymer material.

10. In the molding step, 8. The method for manufacturing a skin adhesive patch for negative pressure stimulation according to claim 7, wherein the flexible polymer material is at least one selected from the group consisting of PDMS (Polydimethylsiloxane), Ecoflex, PU (Polyurethane), PANI (Polyaniline), and SEBS (Styrene Ethylene / Butylene Styrene).

11. The polymer precursor coating layer forming step includes:

8. The method for manufacturing a skin adhesive patch for negative pressure stimulation according to claim 7, characterized in that the stamping process step comprises laminating a polymer precursor on the skin adhesive surface of the skin adhesive patch (1) and then performing a stamping process to form the polymer precursor coating layer (50) and the adhesive flange portion (23).

12. The polymer precursor coating layer forming step includes:

8. The method for manufacturing a skin adhesive patch for negative pressure stimulation according to claim 7, characterized in that the method comprises a spray coating step of spraying a polymer precursor onto the skin adhesive surface of the skin adhesive patch (1) to form the polymer precursor coating layer (50).

13. In the step of forming the polymer precursor coating layer, 8. The method for manufacturing a skin adhesive patch for negative pressure stimulation according to claim 7, wherein the polymer precursor comprises at least one selected from the group consisting of PDMS (Polydimethylsiloxane), Ecoflex, PU (Polyurethane), PANI (Polyaniline), and SEBS (Styrene Ethylene / Butylene Styrene).

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