Microneedle patch with removable outer cover

Abstract

Provided is a microneedle patch with a removable outer cover. The microneedle patch with a removable outer cover comprises: a needle portion having a tip at a first end thereof; a backing layer which is integrally formed with the needle portion at a second end of the needle portion to support the needle portion and has a cross-sectional area of a predetermined size; an attachment assisting portion which is attached to the backing layer in a direction opposite to the needle portion and assists the attachment of the needle portion and the backing layer to the skin; and an outer cover which surrounds the needle portion and the backing layer from the first end toward the second end to protect the needle portion and is removed before insertion of the needle portion into the skin.

Description

Microneedle patch with external skin removal

[0001] The present invention relates to a microneedle patch, and more specifically, but not exclusively, to a skin-removable microneedle patch.

[0002] Various methods for injecting drugs or cosmetic ingredients into the body are known. Among these, one method that has recently gained attention is injection using microneedle patches. Microneedle patches are typically used to effectively deliver small amounts of drugs or cosmetic ingredients into the body by inserting micrometer-sized needles. They have recently been widely used in the medical and cosmetic fields. Among these microneedle patches, those made of dissolvable biocompatible materials offer several advantages: minimal pain when applied to the skin; the ability to penetrate the epidermis and deliver drugs or cosmetic ingredients to an appropriate depth, resulting in high drug delivery efficiency and minimal side effects; and the microneedles dissolving within the body, resulting in minimal waste excretion.

[0003] However, conventional microneedle patches have a problem in that the microneedle is often damaged during the process of peeling the microneedle patch from the mold for forming the microneedle patch, which reduces the manufacturing yield of the microneedle patch.

[0004] In addition, it was difficult to sufficiently safely protect the microneedle patches without damaging the microneedle during the distribution process of the microneedle patch, and in order to protect the microneedle patch, a separate, complex process was required to provide the package, which resulted in an increase in the manufacturing cost of the microneedle patch.

[0005] In addition, existing microneedle patches have the disadvantage of being difficult for users to use in the desired form according to their individual needs because they are provided in fixed sizes and shapes.

[0006] Conventional microneedle patches have suffered from manufacturing issues, such as damage to the microneedles, which reduces productivity. Furthermore, the need for a separate, complex packaging structure to protect the microneedle patches has increased manufacturing costs. Furthermore, the microneedle patches, which are supplied in a fixed format, have made it difficult to meet the diverse needs of users.

[0007] One object of the present invention to solve the above-mentioned problem is to provide a microneedle patch comprising a needle portion, a base layer formed integrally with the needle portion, an attachment assistance portion that assists attachment of the needle portion and the base layer, and an outer shell that protects the needle portion, and which can protect the microneedle patch without damage during the manufacturing and distribution process by adjusting the adhesion or support force between them.

[0008] One object of the present invention to solve the aforementioned problem is to provide a microneedle patch that can be used according to the needs of a user by forming a combination of a needle portion and a base layer into a plurality of cuttable arrays.

[0009] Another object of the present invention to solve the above-mentioned problem is to provide a method for manufacturing a microneedle patch that is simple in production process and highly safe during distribution process by sealing and packaging the needle part, base layer, attachment auxiliary part, and outer skin.

[0010] However, the problem to be solved by the present invention is not limited thereto, and may be expanded in various ways without departing from the spirit and scope of the present invention.

[0011] According to one embodiment of the present invention for achieving the above-described object, a microneedle patch of a skin-removable type may include: a needle portion having a tip at a first end; a base layer formed integrally with the needle portion at a second end thereof to support the needle portion and having a cross-sectional area of ​​a predetermined size; an attachment assistance portion attached to the base layer in an opposite direction to the needle portion and assisting attachment of the needle portion and the base layer to the skin; and an outer skin that surrounds the needle portion and the base layer from the first end toward the second end to protect the needle portion, and is removed prior to insertion of the needle portion into the skin.

[0012] According to one aspect, the needle portion and the base layer may be provided in multiple numbers, and each of the combinations may be arranged spaced apart from each other.

[0013] According to one aspect, the cross-sectional area of ​​the base layer can be determined to a size that can prevent damage to the needle portion when the outer skin is removed.

[0014] According to one aspect, the cross-sectional area of ​​the base layer may be such that the adhesive force between the base layer and the attachment auxiliary part is greater than the adhesive force between the base layer and at least one of the needle parts and the outer skin.

[0015] According to one aspect, the cross-sectional area of ​​the base layer may be such that the support force between the needle portion and the base layer is greater than the adhesion force between at least one of the base layer and the needle portion and the outer skin.

[0016] According to one aspect, the attachment auxiliary part can be formed such that the adhesive force between the base layer and the attachment auxiliary part is greater than the adhesive force between the attachment auxiliary part and the outer skin.

[0017] According to one aspect, the attachment auxiliary part may at least partially include a separation member that separates the attachment auxiliary part and the outer shell between the outer shell and the attachment auxiliary part.

[0018] According to one aspect, at least some of the plurality of combinations constitute an array, and the plurality of arrays can be integrally attached on the attachment auxiliary member.

[0019] According to one aspect, the attachment auxiliary part can be formed of a flexible material.

[0020] According to one aspect, the attachment auxiliary member may have a cutting groove of a predetermined shape along a boundary between the plurality of arrays.

[0021] According to one aspect, the attachment auxiliary part may be an adhesive band.

[0022] According to one aspect, the outer shell can be formed of a flexible material.

[0023] According to one aspect, the outer shell is deformable when removed, and the needle portion can maintain its shape even when the outer shell is deformed.

[0024] According to one aspect, the outer shell may be a mold used for forming the needle portion and the base layer.

[0025] According to one aspect, the outer shell can be formed of a porous material.

[0026] According to one aspect, the present invention may further include a packaging material that seals and surrounds the needle portion, the base layer, the attachment auxiliary portion, and the outer skin.

[0027] According to one aspect, the packaging material contains nitrogen therein, and the outer shell is formed of a porous material, so that the nitrogen can prevent damage and deterioration of at least one of the needle portion, the base layer, the attachment auxiliary portion, and the outer shell.

[0028] According to one aspect, a bubble structure having a cavity between the base layer and the needle portion may be further included.

[0029] According to one aspect, the size of the cross-sectional area of ​​the basal layer can be adjusted by at least partially spraying a predetermined amount of hyaluronic acid.

[0030] According to one embodiment of the present invention for achieving the above-described purpose, a method for manufacturing a microneedle patch of a skin removal type may include: forming a needle portion in a mold for forming a microneedle patch; forming a base layer on the needle portion; drying the base layer; attaching an attachment auxiliary portion on the base layer; and sealing the mold, the needle portion, the base layer, and the attachment auxiliary portion.

[0031] The disclosed technology may have the following effects. However, this does not mean that a particular embodiment must include all or only the following effects, and therefore the scope of the disclosed technology should not be construed as being limited thereby.

[0032] According to the microneedle patch of the above-described outer skin type according to one embodiment of the present invention, the microneedle patch includes an outer skin that protects the microneedle, and by adjusting the cross-sectional area of ​​the base layer and the support and adhesive strength between the needle part, the base layer, the attachment auxiliary part, or the outer skin, the microneedle can be safely delivered to the consumer without damage during the manufacturing and distribution process, and damage to the microneedle can be prevented even when the outer skin is peeled.

[0033] In addition, a microneedle patch that can be used according to the user's needs can be provided by forming a combination of a needle portion and a base layer so that it can be cut into a desired shape as a plurality of arrays.

[0034] In addition, according to the method for manufacturing a microneedle patch of a skin-removable type according to an embodiment of the present invention described above, by forming and sealing the needle portion, the base layer, the attachment auxiliary portion, and the skin, the production process is simple and the microneedle can be safely delivered during the distribution process.

[0035] FIG. 1 is a drawing showing an integrated outer skin removal type micro needle patch according to one embodiment of the present invention.

[0036] FIG. 2 is a drawing showing a detachable microneedle patch according to one embodiment of the present invention.

[0037] FIG. 3 is a cross-sectional view of an integrally formed, skin-removable microneedle patch according to one embodiment of the present invention.

[0038] FIG. 4a and FIG. 4b are drawings showing examples of cutting grooves of a skin-removable microneedle patch according to one embodiment of the present invention.

[0039] FIG. 5 is a drawing showing an example of a microneedle patch and packaging material with a removable outer skin according to one embodiment of the present invention.

[0040] Figure 6 is a flow chart showing a method for manufacturing a skin-removable microneedle patch according to one embodiment of the present invention.

[0041] The present invention can be modified in various ways and has various embodiments, and specific embodiments are illustrated in the drawings and described in detail.

[0042] However, this is not intended to limit the present invention to a specific embodiment, but should be understood to include all modifications, equivalents, or substitutes included in the spirit and technical scope of the present invention.

[0043] While terms such as "first" and "second" may be used to describe various components, these components should not be limited by these terms. These terms are used solely to distinguish one component from another. For example, without departing from the scope of the present invention, a first component may be referred to as a "second component," and similarly, a second component may also be referred to as a "first component." The term "and / or" includes any combination of multiple related items described herein or any item among multiple related items described herein.

[0044] When a component is referred to as being "connected" or "connected" to another component, it should be understood that it may be directly connected or connected to that other component, but that there may be other components intervening. Conversely, when a component is referred to as being "directly connected" or "connected" to another component, it should be understood that there are no other components intervening.

[0045] The terminology used in this application is only used to describe specific embodiments and is not intended to limit the present invention. The singular expression includes the plural expression unless the context clearly indicates otherwise. In this application, it should be understood that the terms "comprise" or "have" indicate the presence of a feature, number, step, operation, component, part, or combination thereof described in the specification, but do not exclude in advance the possibility of the presence or addition of one or more other features, numbers, steps, operations, components, parts, or combinations thereof.

[0046] Unless otherwise defined, all terms used herein, including technical or scientific terms, have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. Terms defined in commonly used dictionaries should be interpreted as having a meaning consistent with their meaning in the context of the relevant technology, and will not be interpreted in an idealized or overly formal sense unless explicitly defined herein.

[0047] Hereinafter, with reference to the attached drawings, preferred embodiments of the present invention will be described in more detail. In order to facilitate an overall understanding in describing the present invention, identical reference numerals will be used for identical components in the drawings, and redundant descriptions of identical components will be omitted.

[0048]

[0049] As previously discussed, conventional microneedle patches had problems with the microneedles being damaged during the process of peeling the microneedle patch from the mold, required a complex production process to safely deliver the microneedle patch to consumers, and made it difficult to use the microneedle patch according to consumer needs.

[0050] A microneedle patch of a skin-removable type according to one embodiment of the present invention is intended to solve the above-mentioned problems, and provides a needle portion, a base layer, an attachment auxiliary portion, and an outer skin, and adjusts the adhesive force or support force between them, so that the microneedle may not be damaged when the microneedle patch is peeled off, the microneedle patch may be used according to the needs of the user, and the microneedle patch may be safely delivered to the consumer without damage or deterioration of the microneedle through a simple production process.

[0051]

[0052] Below, a more specific description will be given of a skin-removable microneedle patch according to one embodiment of the present invention with reference to the drawings.

[0053]

[0054] Hereinafter, the term 'bubble structure' in this description should be understood as a general term for a structure with an empty interior, and the shape of the bubble structure is not limited to a certain shape such as a circle or a sphere, but can be any shape that can be formed during manufacturing.

[0055] In addition, hereinafter, the term 'biocompatible material' in this description broadly refers to a material that can be safely used on the human body, and may include all biocompatible active substances such as compounds that can be generally used for the purposes of disease treatment, symptom relief, prevention, beauty, etc., and biocompatible materials for forming microneedles that dissolve in the body, and is not limited to the examples described in this specification.

[0056]

[0057] FIG. 1 is a drawing showing an integrally formed microneedle patch (10) according to one embodiment of the present invention, and FIG. 2 is a drawing showing an isolated microneedle patch (10) according to one embodiment of the present invention. Hereinafter, a microneedle patch (10) according to one embodiment of the present invention will be described with reference to FIGS. 1 and 2.

[0058] As illustrated in FIGS. 1 and 2, a microneedle patch (10) of a skin-removable type according to one embodiment of the present invention may include a needle portion (100), a base layer (200), an attachment auxiliary portion (300), and a skin (400). The needle portion (100) may be manufactured by injecting a biocompatible material for forming the needle portion (100) into a mold for forming the microneedle. In one aspect, the needle portion (100) may be formed by including a biocompatible active material, such as a cosmetic ingredient or a pharmacological ingredient, therein.

[0059] Referring to the enlarged view of FIG. 2, the needle portion (100) may have a tip at the first end (110). A base layer (200) may be provided at the second end (120) of the needle portion (100). In the drawing, the needle portion (100) is depicted as having a conical shape and the base layer (200) is depicted as having a circular cross-section, but the shapes of the needle portion (100) and the base layer (200) are not limited thereto.

[0060] The base layer (200) can be formed integrally with the needle part (100) at the second end (120) of the needle part (100) to support the needle part (100). As shown, a plurality of combinations (A) of the needle part (100) and the base layer (200), in which the needle part (100) and the base layer (200) are integrally connected, can be provided in the skin-removable microneedle patch (10) according to one embodiment of the present invention, and each combination (A) can be arranged to be spaced apart from each other as shown in FIGS. 1 and 2.

[0061] In the opposite direction of the direction in which the needle portion (100) of the basal layer (200) is connected, an attachment auxiliary portion (300) that can assist in the attachment of the needle portion (100) and the basal layer (200) to the skin can be attached. A plurality of attachment auxiliary portions (300) can be attached to the combination (A) of the needle portion (100) and the basal layer (200) in a state of being spaced apart from each other. In one aspect, the attachment auxiliary portion (300) can have an adhesive force on the side to which the combination (A) of the needle portion (100) and the basal layer (200) is attached. In addition, the attachment auxiliary portion (300) can be formed of at least one flexible material selected from the group consisting of, for example, a medical adhesive band, an adhesive covering material, or an adhesive hydrocolloid patch. However, the material of the attachment auxiliary part (300) is not limited to the technical idea of ​​the present invention as described above, and any adhesive band that can assist in attaching the combination (A) of the needle part (100) and the base layer (200) to the skin may be used.

[0062] The outer shell (400) has a concave portion (410) capable of accommodating a combination (A) of a needle portion (100) and a base layer (200), as illustrated in FIGS. 1 and 2, and the size and shape of the concave portion (410) may be substantially the same as those of the combination (A) of the needle portion (100) and the base layer (200). This outer shell (400) can protect the needle portion (100) by surrounding the needle portion (100) and the base layer (200) in the direction from the first end (110) to the second end (120). The outer skin (400) can be removed, for example separated or peeled, from the combination (A) of the needle portion (100) and the basal layer (200) and the attachment auxiliary portion (300) immediately prior to inserting the needle portion (100) into the user's skin.

[0063] This outer shell (400) can be formed of a flexible material, and thus, the outer shell (400) can be deformable when removed. For example, the outer shell (400) can be separated from the microneedle patch by deforming only the outer shell (400) while the microneedle patch in the concave portion (410) of the outer shell (400) remains intact by bending or bending at least a portion of the flexible outer shell (400) to separate it from the combination (A) of the needle portion (100) and the base layer (200) and the attachment auxiliary portion (300). Therefore, the needle portion (100) can maintain its shape even when the outer shell (400) is deformed. That is, the needle part (100) can be separated from the outer shell (400) by deforming the outer shell (400) to separate the needle part (100) and the outer shell (400), and accordingly, the needle part (100) can be separated from the outer shell (400) without applying a deformation force or impact to the needle part (100), and the needle part (100) can be protected without damage until the outer shell (400) is removed.

[0064] In one aspect, the outer shell (400) can be formed of a porous material. The outer shell (400) can be formed of at least one material selected from the group consisting of various materials having porosity and flexibility, such as, for example, polyurethane, polyvinyl alcohol, polyester, polycaprolactone, polymethyl acrylate, elastomer, and silicone-based polymers. In one aspect, in the outer shell-removable microneedle patch (10) according to one embodiment of the present invention, among the various materials described above, PDMS (Polydimethiylsiloxane), a silicone-based polymer having excellent porosity and flexibility, can be used as the material of the outer shell (400). In one aspect, the outer shell (400) can be a mold used for molding the needle portion (100) and the base layer (200). More specifically, the outer shell (400) may be a mold that can form a microneedle patch by injecting a material for forming the needle portion (100) and the base layer (200) into the engraved portion (410) and forming a variety of materials having flexibility and porosity as described above, and such a mold can act as the outer shell (400) and protect the needle portion (100) without damage until immediately before use of the microneedle patch.

[0065]

[0066] As described above, when manufacturing a microneedle patch by injecting a material for forming a microneedle patch into a mold, a predetermined bonding force, i.e., adhesive force, may occur between the mold and the microneedle patch as the microneedle patch dries. Accordingly, a force exceeding the adhesive force may be required to separate the microneedle patch from the mold, and if this force is not properly controlled, damage to the microneedle patch may occur.

[0067] Therefore, the microneedle patch (10) of the outer skin removal type according to one embodiment of the present invention can effectively remove the outer skin (400) by adjusting the cross-sectional area of ​​the basal layer (200) to safely remove the outer skin (400) having the characteristics described above without damaging the microneedle patch. To this end, according to one aspect of the present invention, the basal layer (200) can have a cross-sectional area of ​​a predetermined size. More specifically, the cross-sectional area of ​​the basal layer (200) can be determined to a size that can prevent damage to the needle portion (100) when removing the outer skin (400).

[0068] To explain this with an example, if the cross-sectional area of ​​the base layer (200) in the combination (A) of the needle portion (100) and the base layer (200) is too large, the adhesive force between the combination (A) of the needle portion (100) and the base layer (200) and the outer skin (400) becomes excessively large, and thus the possibility of damage to the needle portion (100) increases when the outer skin (400) is separated. That is, if the cross-sectional area of ​​the base layer (200) is excessively large, the adhesive force between the outer skin (400) and the base layer (200) becomes too strong when the needle portion (100) and the outer skin (400) are separated, making separation difficult, and applying excessive force for separation may result in damage to the needle portion (100).

[0069] On the other hand, if the cross-sectional area of ​​the base layer (200) in the combination (A) of the needle portion (100) and the base layer (200) is too small, the support force of the base layer (200) for the needle portion (100) becomes small, so the possibility of the needle portion (100) being damaged when the outer skin (400) is separated may increase. That is, when the cross-sectional area of ​​the base layer (200) is small, the adhesive force between the base layer (200) and the outer skin (400) may be small, so that the separation of the base layer (200) from the outer skin (400) may be easy. However, because the cross-sectional area of ​​the base layer (200) is excessively small, the support force between the base layer (200) and the needle part (100) may also be small, and when the outer skin (400) is separated, the possibility that the needle part (100) will be separated from the base layer (200) together with the outer skin (400) increases, so the possibility of damage to the needle part (100) may also increase.

[0070] Accordingly, in order to separate the needle portion (100) of the microneedle patch (10) from the outer skin (400) without damage, the cross-sectional area of ​​the base layer (200) can be formed by determining the cross-sectional area size of the base layer (200) that can prevent damage to the needle portion (100) by considering the adhesive force between the outer skin (400) and the needle portion (100) and between the outer skin (400) and the base layer (200).

[0071]

[0072] In addition, in one aspect, the cross-sectional area of ​​the base layer (200) may have a size that can prevent damage to the needle portion (100) by considering the adhesive force between the base layer (200) and the attachment auxiliary portion (300) and between the outer skin (400) and the attachment auxiliary portion (300). More specifically, in one aspect, the cross-sectional area of ​​the base layer (200) may have a size that makes the adhesive force between the base layer (200) and the attachment auxiliary portion (300) greater than the adhesive force between at least one of the base layer (200) and the needle portion (100) and the outer skin (400). That is, the cross-sectional area of ​​the base layer (200) may be such that, when the outer skin (400) is separated, the attachment of the needle portion (100) and the combination (A) of the base layer (200) and the attachment auxiliary portion (300) to the attachment auxiliary portion (300) is maintained while only the outer skin (400) can be removed, so that the adhesive force between the base layer (200) and the attachment auxiliary portion (300) may be greater than the adhesive force between the combination (A) of the needle portion (100) and the base layer (200) and the outer skin (400).

[0073] As a non-limiting example, the cross-sectional area of ​​the base layer (200) may be determined based on i) a contact area between the attachment auxiliary portion (300) of the base layer (200) and the outer skin (400) of the combination (A) of the needle portion (100) and the base layer (200) (hereinafter, may be referred to as the 'upper area'). According to one aspect, the cross-sectional area of ​​the base layer (200) may be determined such that the lower area and the upper area are equal. According to another aspect, the cross-sectional area of ​​the base layer (200) may be determined such that a difference between the lower area and the upper area is less than a predetermined critical area difference value. Here, the critical area difference value can be determined differently depending on the material of at least a part of the needle portion (100), the base layer (200), the attachment auxiliary portion (300), or the outer skin (400) or a combination thereof.

[0074] In addition, in one aspect, the cross-sectional area of ​​the base layer (200) may be such that the support force between the needle portion (100) and the base layer (200) is greater than the adhesion force between at least one of the base layer (200) and the needle portion (100) and the outer skin (400). That is, the cross-sectional area of ​​the base layer (200) may be such that the outer skin (400) can be removed from the needle portion (100) and the base layer (200) in a state where the combination (A) of the needle portion (100) and the base layer (200) is not damaged and maintains its shape even when the outer skin (400) is removed, in other words, the base layer (200) is not separated from the needle portion (100) and can reliably support the needle portion (100).

[0075] Accordingly, in order to separate the needle portion (100) of the microneedle patch (10) from the outer skin (400) without damage, the cross-sectional area of ​​the base layer (200) can be formed by determining the cross-sectional area size of the base layer (200) that can prevent damage to the needle portion (100) by considering the adhesive force between the base layer (200) and the attachment auxiliary portion (300) and the support force between the needle portion (100) and the base layer (200).

[0076]

[0077] FIG. 3 is a cross-sectional view of an integrally formed, skin-removable microneedle patch according to one embodiment of the present invention.

[0078] In one aspect, the skin-removable microneedle patch (10) according to one embodiment of the present invention may further include a bubble structure (130) having a cavity between the base layer (200) and the needle portion (100). The bubble structure (130) may be formed separately from the base layer (200) in the middle of the needle portion (100), as illustrated in an enlarged view at reference numeral 3a of FIG. 3, or may be formed at a point where the base layer (200) and the needle portion (100) are connected, as illustrated in an enlarged view at reference numeral 3b of FIG. 3. The shape of the bubble structure (130) illustrated in FIG. 3 is merely an example, and the bubble structure (130) may be formed in various shapes and positions that are not limited to those illustrated in FIG. 3.

[0079] In one aspect, the microneedle patch (10) of the outer skin type including the bubble structure (130) may have more important adjustments in the support force between the needle portion (100) and the base layer (200) and the adhesive force between the combination (A) of the needle portion (100) and the base layer (200) and the outer skin (400) when the outer skin (400) is removed due to the bubble structure (130). More specifically, when a bubble structure (130) is included inside the needle portion (100), there is a possibility that the needle portion (100) may be damaged when the outer skin (400) is peeled off due to the weakening of the supporting force between the needle portion (100) and the base layer (200) caused by the bubble structure (130). Therefore, the outer skin-removable microneedle patch (10) including the bubble structure (110) according to one embodiment of the present invention can form a base layer (200) having a cross-sectional area that is appropriately adjusted in size so as not to damage the needle portion (100) by considering the size of the supporting force between the needle portion (100) and the base layer (200) and the adhesive force between the microneedle patch and the outer skin (400) as described above.

[0080] In one aspect, the size of the cross-sectional area of ​​such a basal layer (200) can be adjusted by at least partially spraying a predetermined amount of hyaluronic acid. Specifically, various biocompatible materials can be used to form the basal layer (200), and such biocompatible materials can be applied to various materials including, for example, hyaluronic acid, but are not limited thereto. Hyaluronic acid is a polysaccharide existing in the human body, and is a biodegradable polymer compound composed of N-acetylglucosamine and glucuronic acid, and has high moisture absorption capacity, moisture retention function, flexibility, and skin protection function. As described above, after injecting a material for forming a needle portion (100) into the engraved portion (410) formed on the outer skin (400), a hyaluronic acid solution of a predetermined amount is sprayed at least partially onto the needle portion (100) to form a cross-sectional area of ​​the base layer (200) of a size adjusted to prevent damage to the needle portion (100), thereby obtaining a base layer (200) of a desired cross-sectional area size.

[0081]

[0082] In one aspect, in order to remove the outer skin (400) without damaging the needle portion (100), not only the cross-sectional area of ​​the base layer (200) but also the adhesive strength of the attachment auxiliary portion (300) must be adjusted in the outer skin removal type microneedle patch (10).

[0083] In this regard, the attachment auxiliary member (300) may be formed so that the adhesive force between the base layer (200) and the attachment auxiliary member (300) is greater than the adhesive force between the attachment auxiliary member (300) and the outer skin (400). More specifically, the attachment auxiliary member (300) may be formed so that the adhesive force between the base layer (200) and the attachment auxiliary member (300) is maintained when the outer skin (400) is removed, while only the outer skin (400) can be removed.

[0084] In one aspect, the attachment auxiliary member (300) may at least partially include a separation member (310) that separates the attachment auxiliary member (300) and the outer skin (400) between the outer skin (400) and the attachment auxiliary member (300). For example, the separation member (310) may be a special sheet or separation film formed around the outer skin (400) and the attachment auxiliary member (300) as illustrated in the drawing reference numeral 3c of FIG. 3, and the adhesion force between the attachment auxiliary member (300) and the outer skin (400) is reduced by the separation member (310), thereby facilitating the separation of the outer skin (400) and the attachment auxiliary member (300). In addition, although not shown in the drawing, the separation member (310) may be arranged on one side with a predetermined gap between the combinations (A) of the plurality of needle portions (100) and the base layer (200) so that the combinations (A) of the needle portions (100) and the base layer (200) are at least partially separated. In addition, although not shown in the drawing, the separation member may have, on one side, a shape of a groove formed at least partially on the side of the attachment auxiliary portion (300) that contacts the outer skin (400), and by forming such a groove, the adhesive force between the attachment auxiliary portion (300) and the outer skin (400) may be reduced, thereby facilitating the separation of the attachment auxiliary portion (300) and the outer skin (400).

[0085]

[0086] FIG. 4a and FIG. 4b are drawings showing examples of cutting grooves of a skin-removable microneedle patch according to one embodiment of the present invention.

[0087] According to one embodiment of the present invention, the microneedle patch (10) of the skin removal type can be made of a material having a flexible attachment assistant part (300) and an outer skin (400), so that it can be cut into a required shape and used. Referring to FIG. 4A, at least some of the combinations (A) of the plurality of needle parts (100) and the base layer (200) on one side can form an array (320) having an arbitrary shape, and such an array (320) can be integrally attached on the attachment assistant part (300). In addition, as shown in FIG. 4B, the attachment assistant part (300) can be formed in a plurality of arrays (320) formed of the combinations (A) of the plurality of needle parts (100) and the base layer (200) on one side in a desired shape on the attachment assistant part (300).

[0088] In one aspect, the attachment auxiliary part (300) may have a cutting groove (330) of a predetermined shape, for example, along the boundary between a plurality of arrays (320), as illustrated in FIGS. 4A and 4B. The shape of the cutting groove (330) may be determined differently depending on the shape of the skin surface to which the microneedle patch is to be attached. For example, when extensive attachment to a large surface area is required, the cutting groove (330) may be formed to include a plurality of arrays (320), as illustrated in FIG. 4A, and when localized attachment to a narrow surface area is required, the cutting groove (330) may be formed to include a plurality of arrays (320) according to the shape of the desired area, as illustrated in FIG. 4B. The cutting groove (330) may be cut using a cutting means such as scissors, for example, and a portion on one side where the cutting groove (330) is not formed may be cut and used as needed. In addition, as shown in FIG. 3, when the skin-removable microneedle patch (10) according to one embodiment of the present invention includes a bubble structure (110), the bubble structure (110) acts as a line or point that is easy to cut, so that it is possible to cut and use the skin-removable microneedle patch (10) according to one embodiment of the present invention in a desired shape without a separate cutting groove (330).

[0089] Although FIGS. 4A and 4B illustrate a cutting groove (330) having a predetermined shape as an example, the cutting groove (330) may be formed to assist the user in cutting into a desired shape as needed for use. As a non-limiting example, the cutting groove (330) may be formed in a grid pattern to enable the user to form an array prior to application to the skin, including a desired number of needle portions (100) and a combination (A) of a base layer (200). In addition, it may also be possible to form an array including a plurality of combinations (A) in a shape desired by the user.

[0090] FIG. 5 is a drawing showing an example of a microneedle patch and packaging material with a removable outer skin according to one embodiment of the present invention.

[0091] In one aspect, the microneedle patch (10) of the type that removes the skin according to one embodiment of the present invention may further include a packaging material (500) that seals and surrounds the needle portion (100), the base layer (200), the attachment auxiliary portion (300), and the skin (400). The packaging material (500) may contain nitrogen therein. The packaging material (500) containing nitrogen may generally be formed of a plastic film, and by replacing the oxygen inside the packaging material with nitrogen, it may prevent the oxygen reaction of the internal product, thereby preventing the deterioration of the internal product, and since the manufacturing process is relatively simple, it may be widely used in the food and pharmaceutical fields.

[0092] In one aspect, the outer shell (400) of the outer shell-removable microneedle patch (10) according to one embodiment of the present invention is formed of a porous material, and the packaging material (500) contains nitrogen therein, so that oxygen reaction is blocked inside the packaging material (500) and nitrogen can pass through the porous outer shell (400), thereby preventing deterioration of at least one of the needle portion (100), the base layer (200), the attachment auxiliary portion (300), and the outer shell (400). In addition, the nitrogen filled inside the packaging material (500) applies pressure inside the packaging material (500) to protect the structure of the outer shell-removable microneedle patch (10) and alleviate external impact, thereby preventing damage to the outer shell-removable microneedle patch (10).

[0093]

[0094] FIG. 6 is a flowchart illustrating a method (600) for manufacturing a skin-removable microneedle patch (10) according to one embodiment of the present invention. To explain the method (600) for manufacturing a skin-removable microneedle patch (10) according to one embodiment of the present invention, reference is also made to FIGS. 1 to 5, which describe a skin-removable microneedle patch (10).

[0095] In order to manufacture a microneedle patch (10) of a skin-removable type according to one embodiment of the present invention, a needle portion (100) may first be formed in a mold for forming a microneedle patch (610). The mold for forming the microneedle patch may be, for example, the skin (400) according to one embodiment of the present invention as described above, and the mold may be formed of a material having flexibility and porosity. A material for forming the needle portion (100) may be injected into the engraved portion (410) of the mold to form the needle portion (100).

[0096] After the needle portion (100) is formed, a base layer (200) can be formed on the needle portion (100) (620). In one aspect, the base layer (200) can be formed to have a predetermined cross-sectional area by, for example, at least partially spraying hyaluronic acid. Thereafter, the base layer (200) can be dried (630). Drying can be performed under suitable temperature, humidity, and time conditions, for example, depending on the desired strength or required degree of adhesiveness of the microneedle patch. Thereafter, an attachment aid (300) can be attached on the dried base layer (200) (640). For example, the attachment aid (300) can be any adhesive band having flexibility and adhesiveness, and can also be provided with a cutting groove (330) that can be cut into a required shape. After the needle portion (100), the base layer (200), the attachment auxiliary portion (300), and the mold are integrally formed through the above-described steps, the mold, the needle portion (100), the base layer (200), and the attachment auxiliary portion (300) can be sealed (650). The sealing can be accomplished, for example, by a packaging material (500) as described above, and the packaging material (500) can also include nitrogen therein to protect the outer skin-removable microneedle patch (10) therein.

[0097] By going through the steps described above, a microneedle patch (10) of a skin-removable type can be formed with a cross-sectional area of ​​a size adjusted in consideration of the adhesive force or support force between the needle portion (100), the base layer (200), the attachment auxiliary portion (300), and the outer skin (400) according to one embodiment of the present invention, and by sealing the microneedle patch including the outer skin (400) with a packaging material (500), a microneedle patch (10) can be provided that can protect the needle portion (100) without damage until the needle portion (100) is inserted into the skin.

[0098]

[0099] Although the present invention has been described with reference to the drawings and embodiments, it does not mean that the scope of protection of the present invention is limited by the drawings or embodiments, and it will be understood that a person skilled in the art can variously modify and change the present invention within a scope that does not depart from the spirit and scope of the present invention as described in the following claims.

[0100] Although the present invention described above is described based on a series of functional blocks, it is not limited to the above-described embodiments and the attached drawings, and it will be apparent to those skilled in the art to which the present invention pertains that various substitutions, modifications, and changes are possible within a scope that does not depart from the technical spirit of the present invention.

[0101] The combination of the above-described embodiments is not limited to the above-described embodiments, and various combinations may be provided in addition to the above-described embodiments depending on implementation and / or needs.

[0102] In the above-described embodiments, the methods are described based on a flowchart as a series of steps or blocks. However, the present invention is not limited to the order of the steps, and some steps may occur in a different order or simultaneously with other steps described above. Furthermore, those skilled in the art will understand that the steps depicted in the flowchart are not exclusive, and that other steps may be included, or one or more steps in the flowchart may be deleted without affecting the scope of the present invention.

[0103] The above-described embodiments include examples of various aspects. While not all possible combinations can be described to illustrate the various aspects, those skilled in the art will recognize that other combinations are possible. Accordingly, the present invention is intended to encompass all other alterations, modifications, and variations within the scope of the following claims.

[0104] [Explanation of symbols]

[0105] 10: Microneedle patch with external skin removal

[0106] 100: Needle

[0107] 110: Part 1

[0108] 120: Part 2

[0109] 130: Bubble structure

[0110] 200: Basal layer

[0111] A: combination

[0112] 300: Attachment auxiliary part

[0113] 310: Separation member

[0114] 320: Array

[0115] 330: Cutting groove

[0116] 400: Outer skin

[0117] 500: Packaging material

Claims

1. A needle part having a tip at the first end; A base layer formed integrally with the needle portion at the second end of the needle portion to support the needle portion and having a cross-sectional area of ​​a predetermined size; An attachment auxiliary part attached to the opposite direction of the needle part of the basal layer and assisting attachment of the needle part and the basal layer to the skin; and A skin that surrounds the needle portion and the basal layer from the first end toward the second end to protect the needle portion, and is removed prior to insertion of the needle portion into the skin; A microneedle patch with a removable outer layer.

2. In paragraph 1, The above needle portion and base layer combination is provided in multiple numbers, and each combination is spaced apart from each other. A microneedle patch with a removable outer layer.

3. In paragraph 2, The cross-sectional area of ​​the above base layer is When removing the above outer skin, the size is determined to be such that damage to the needle part can be prevented. A microneedle patch with a removable outer layer.

4. In paragraph 2, The cross-sectional area of ​​the above base layer is Having a size such that the adhesion force between the base layer and the attachment auxiliary part is greater than the adhesion force between at least one of the base layer and the needle part and the outer skin. A microneedle patch with a removable outer layer.

5. In paragraph 2, The cross-sectional area of ​​the above base layer is The support force between the needle portion and the base layer is of a size that is greater than the adhesion force between at least one of the needle portion and the base layer and the outer skin. A microneedle patch with a removable outer layer.

6. In paragraph 2, The above attachment auxiliary part is, The adhesive force between the base layer and the attachment auxiliary part is formed to be greater than the adhesive force between the attachment auxiliary part and the outer skin. A microneedle patch with a removable outer layer.

7. In paragraph 6, The above attachment auxiliary part is, At least partially including a separation member separating the attachment auxiliary part and the outer shell between the outer shell and the attachment auxiliary part, A microneedle patch with a removable outer layer.

8. In paragraph 2, At least some of the above plurality of combinations constitute an array, and the plurality of arrays are integrally attached on the attachment auxiliary member. A microneedle patch with a removable outer layer.

9. In paragraph 8, The above attachment auxiliary part is, Formed from a flexible material, A microneedle patch with a removable outer layer.

10. In paragraph 9, The above attachment auxiliary part is, Having a predetermined shape of cutting grooves along the boundaries between the above plurality of arrays, A microneedle patch with a removable outer layer.

11. In paragraph 10, The above attachment auxiliary part is an adhesive band, A microneedle patch with a removable outer layer.

12. In paragraph 10, The above outer shell is formed of a flexible material, A microneedle patch with a removable outer layer.

13. In paragraph 12, The above outer skin is deformable when removed, and the needle portion maintains its shape even when the outer skin is deformed. A microneedle patch with a removable outer layer.

14. In paragraph 1, The above outer shell, A mold used for forming the above needle portion and the base layer, A microneedle patch with a removable outer layer.

15. In paragraph 14, The above outer shell, Formed from a porous material, A microneedle patch with a removable outer layer.

16. In paragraph 1, Further comprising a packaging material that seals and surrounds the needle portion, the base layer, the attachment auxiliary portion, and the outer skin. Microneedle patch with external skin removal 17. In paragraph 16, The packaging material contains nitrogen inside, and the outer shell is formed of a porous material, so that the nitrogen prevents damage and deterioration of at least one of the needle portion, the base layer, the attachment auxiliary portion, and the outer shell. A microneedle patch with a removable outer layer.

18. In paragraph 1, Further comprising a bubble structure having a cavity between the base layer and the needle portion, A microneedle patch with a removable outer layer.

19. In paragraph 18, The size of the cross-sectional area of ​​the above basal layer is adjusted by at least partially spraying a predetermined amount of hyaluronic acid, A microneedle patch with a removable outer layer.

20. Step of forming a needle portion in a mold for forming a microneedle patch; A step of forming a base layer on the above needle portion; A step of drying the above base layer; A step of attaching an attachment auxiliary part on the base layer; and A step of sealing the mold, the needle part, the base layer, and the attachment auxiliary part; including; Method for manufacturing a microneedle patch with a skin removal type.

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