WO2014187338A1

WO2014187338A1 - Metal microneedle array, transdermal delivery patch, and microneedle transdermal delivery stamp

Info

Publication number: WO2014187338A1
Application number: PCT/CN2014/078116
Authority: WO
Inventors: 岳瑞峰; 王燕
Original assignee: 清华大学
Priority date: 2013-05-22
Filing date: 2014-05-22
Publication date: 2014-11-27
Also published as: CN103263727B; CN103263727A

Abstract

A metal microneedle array, a transdermal delivery patch with the metal microneedle array, and a microneedle transdermal delivery stamp. The metal microneedle array comprises a substrate (1) and at least one metal sheet (2). The substrate (1) is a solid plate, a solid cylindrical body or a hollow cylindrical body, and has an operation surface in a plane or curved surface shape. The metal sheet (2) is fixed on the substrate (1). Multiple integral microneedles (3) spaced to each other are formed on at least one edge of the metal sheet (2). Each microneedle (3) has a free end and a fixed end connected to the metal sheet (2). A structure of the free end of the microneedle (3) is a needle point (4). The metal sheet (2) is embedded in the operation surface, and at least one part of the microneedle (3) protrudes over the operation surface to form a preset angle with the operation surface. The microneedles (3) in the microneedle array have good consistency, and the manufacturing process of the microneedle array is simplified, and flexibility of the structure design and application is good.

Description

Metal microneedle array, transdermal patch and microneedle transdermal drug seal

The present invention relates to the field of medical cosmetic instruments and medical technology, and in particular to a metal microneedle array, a transdermal patch having the metal microneedle array, and a microneedle transdermal drug seal. Background technique

Medical devices with metal microneedle arrays have found wide application in recent years. Methods for fabricating microneedle arrays are disclosed, for example, in the patent applications CN1562402A, US Pat. No. 20,100,130, 940, AK, CN1, 145, 385, and,,,,,,,,,,,,,,,,,,,,,,,,, Low, poor consistency. Summary of the invention

It is an object of the present invention to provide a metal microneedle array having excellent uniformity between microneedles, a simplified manufacturing process, a significant cost reduction, and flexibility in structural design and application. And the appearance is beautiful.

Another object of the present invention is to provide a transdermal patch having a metal microneedle array capable of increasing the storage amount of each microneedle, and the needle tip of the metal microneedle array is sharp and 剌The drug with small input and carrying is not easy to fall off, the effect of the drug is rapid, and the action time is longer.

A further object of the present invention is to provide a microneedle transdermal drug seal which is easy to handle and simple in structure.

To this end, an embodiment of the first aspect of the present invention provides a metal microneedle array, comprising: a substrate, the substrate being a solid plate, a solid column or a hollow column and having an operation surface, the operation surface being a plane And a curved surface; and the at least one metal foil is fixed on the substrate, and at least one edge of the metal foil is integrally formed with a plurality of microneedles spaced apart from each other, the microneedles having freedom And a fixed end connected to the metal foil, the free end of the microneedle being configured as a needle tip, the metal foil being embedded in the operating surface, and at least a portion of the microneedle protruding from the operating surface and At a predetermined angle to the operating surface.

Preferably, the metal foil is at least two, and the at least two metal foils are parallel and spaced apart from each other. Preferably, only the tip of the microneedle protrudes from the operating surface.

Preferably, the metal foil has a major surface that is perpendicular or coplanar with the major surface of the foil. Preferably, the substrate comprises a polymer.

Preferably, the substrate comprises at least one of plastic and rubber.

Preferably, the substrate is made of epoxy resin.

Preferably, the substrate is made of at least one of plastic and rubber and at least one of metal, wood, ceramic and glass. One made.

Preferably, the surface of the metal foil is formed with a gold film or a platinum film by evaporation, sputtering or electroplating. Preferably, the tip of the needle is pointed.

Preferably, the cross section of the microneedle is in the shape of a line or a smooth curve.

Preferably, the substrate is provided with a positioning groove, and the metal foil is fixed in the positioning groove.

Preferably, the metal foil is rectangular, the substrate is provided with a positioning groove, a first longitudinal side of the metal foil is fixed in the positioning groove, and the microneedle is formed in the second metal foil. On the side of the portrait.

Preferably, the metal foil is annular, the substrate is columnar, and the metal foil is fixed on an outer circumferential surface of the substrate as the operation surface along a circumferential direction of the substrate, the plurality of The metal foils are arranged at an axial interval along the substrate.

Preferably, the metal foil is rectangular, the substrate is columnar, and the metal foil is fixed on an outer peripheral surface of the substrate as the operation surface along an axial direction of the substrate, the plurality of The metal foils are arranged at intervals along the circumference of the substrate.

Preferably, the metal microneedle array further comprises an external lead, the metal foil is provided with an interface, and the external lead is connected to the interface.

An embodiment of the second aspect of the present invention provides a microneedle transdermal patch for use with the above-described metal microneedle array. The microneedle transdermal patch comprises the above metal microneedle array; a transdermal patch layer having at least one therapeutic or cosmetic component, and the transdermal patch layer is coated on the microneedle; And a protective layer covering the microneedles for sealing and protecting the microneedles and the transdermal patch layer.

An embodiment of the third aspect of the present invention provides a microneedle transdermal administration stamp using the above-described metal microneedle array. The microneedle transdermal administration stamp comprises: a base; the metal microneedle array, the substrate is fixed on the base; and a protective cap, the protective cap is connected to the base for The pedestal seals and protects the microneedles together.

The metal microneedle array, the microneedle transdermal patch, and the microneedle transdermal administration stamp according to the embodiment of the present invention have at least the following advantages.

A metal microneedle array according to an embodiment of the present invention, wherein the metal foil having the microneedle at the edge can be mass-produced by a very mature processing technique such as laser, electric spark, electrochemical etching, stamping, etc., and the microneedle and the metal foil are Structure and size can be flexible. Further, the use of computer control can greatly improve processing accuracy, repeatability and consistency. The material disclosed in the embodiment of the present invention is a substrate, and the metal microneedle array of various structural specifications can be assembled in a very convenient manner, which is not only beautiful in appearance, firm in structure, good in consistency, and low in cost.

According to some embodiments of the present invention, the metal microneedle array connected to the electrodes by the external wires can effectively avoid the interference of the high-impedance characteristics of the stratum corneum of the skin, and the measurement is more convenient and reliable, and the signal-to-noise ratio is high.

The microneedle transdermal patch and the microneedle transdermal drug seal according to the embodiment of the present invention are safe, flexible and convenient to use, can carry more drugs, and can effectively prevent the drug from being invaded into the skin. Shedding in vitro. In addition, the use of the microneedle transdermal patch and the microneedle percutaneous administration stamp according to the embodiment of the present invention can not only significantly improve the transdermal permeability of the existing drug, but also rapidly pass the stratum corneum to the drug or cosmetic skin care product. Entering the epidermis layer and the dermis layer, it can significantly improve the efficacy or beauty and beauty effects, and can also expand the types of applicable drugs, and apply more drugs and cosmetics. New agent for skin.

The additional aspects and advantages of the invention will be set forth in part in the description which follows. DRAWINGS

The above and/or additional aspects and advantages of the present invention will become apparent and readily understood from

1 is a schematic illustration of a metal microneedle array in accordance with an embodiment of the present invention;

2 is a cross-sectional view showing the structure of a metal microneedle array according to an embodiment of the present invention.

Figure 33 is a cross-sectional view showing the structure of a metal microneedle array according to an embodiment of the present invention.

4 is a cross-sectional view showing the structure of a metal microneedle array according to an embodiment of the present invention.

Figure 5 is a cross-sectional view showing the structure of a metal microneedle array according to an embodiment of the present invention.

Figure 6 is a schematic illustration of a metal microneedle array in accordance with one embodiment of the present invention:

Figure 7 is a schematic illustration of a metal microneedle array in accordance with one embodiment of the present invention:

Figure 8 is a schematic illustration of a metal microneedle array in accordance with one embodiment of the present invention:

Figure 9 is a cross-sectional view showing the structure of a metal microneedle array according to an embodiment of the present invention;

Figure 10 is a cross-sectional view showing the structure of a metal microneedle array according to an embodiment of the present invention.

Figure 11 is a cross-sectional view showing the structure of a metal microneedle array according to an embodiment of the present invention.

Figure 12 is a cross-sectional view showing the structure of a metal microneedle array according to an embodiment of the present invention.

Figure 1133 is a schematic illustration of a transdermal patch for roots in accordance with one embodiment of the present invention;

Figure 14 is a schematic illustration of a microneedle transdermal drug seal in accordance with an embodiment of the present invention;

Figure 15 is a schematic illustration of a microneedle roller in accordance with an embodiment of the present invention, wherein the microneedle roller includes a metal microneedle array. detailed description

The specific embodiments of the present invention are further described in detail below with reference to the drawings and embodiments. The following examples are intended to illustrate the invention but are not intended to limit the scope of the invention.

A metal microneedle array according to an embodiment of the present invention is described below with reference to the accompanying drawings. As shown in Figures 1 to 12, a metal microneedle array according to an embodiment of the present invention includes a substrate 1 and at least one metal foil 2. The substrate 1 may be a solid plate, a solid column or a hollow column, the substrate has an operation surface, and the operation surface may be a flat surface or a curved surface.

The metal foil 2 is fixed on the substrate 1, and at least one edge of the metal foil 2 is integrally formed with a plurality of microneedles 3 spaced apart from each other. In other words, the microneedles 3 can be formed by processing the edges of the metal foil, which will be Will be described in more detail.

The microneedle 3 has a free end and a fixed end connected to the metal foil 2, and the free end of the microneedle 3 is configured as a needle tip 4. The metal foil 2 is embedded in the operating surface, and at least a portion of the microneedle 3 protrudes from the operating surface, the microneedle 3 being at a predetermined angle to the operating surface. Here, it should be understood that the metal foil 2 embedded in the operation surface may be a metal foil 2 Fully embedded in the substrate, it is also possible that a portion of the foil 2 is embedded in the substrate. At least a portion of the protruding operating surface of the microneedles 3 may be that the microneedles 3 all protrude from the operating surface, or may be a portion, for example, only the tip 4 protrudes from the operating surface.

In other words, the metal microneedle array according to an embodiment of the present invention includes the substrate 1, and a metal foil 2 partially embedded in the substrate 1, and/or a metal foil 2 embedded in the substrate 1 at one side, and / or at least two metal foils 2 arranged at a certain pitch and embedded in the substrate 1, and/or at least two metal foils 2 arranged at a certain pitch and having one side edge embedded in the substrate 1, the metal foil 2 being at least a microneedle array having an outwardly convex shape on one side of the edge thereof, the microneedle array comprising at least two microneedles 3 arranged at a pitch, the microneedle 3 protruding from the surface of the substrate and perpendicular thereto or at a set angle, and The microneedles 3 are perpendicular or coplanar with the main plane in which the central portion of the foil 2 is located, and one end of the microneedles is the tip 4.

The metal microneedle array according to an embodiment of the present invention is not only simple in manufacturing process by integrally forming a microneedle array composed of a plurality of microneedles spaced apart from each other on the edge of the metal foil, and by embedding the metal foil into the substrate The cost is low, the consistency of the microneedles is good, and the structure of the microneedle array is strong, beautiful, and flexible in application.

A metal microneedle array in accordance with an embodiment of the present invention is described below with reference to FIG. As shown in Fig. 1, a metal microneedle array according to this embodiment of the present invention includes a substrate 1 and a plurality of metal foils 2, and the substrate 1 has a rectangular parallelepiped shape, i.e., has a rectangular cross section. As shown in Fig. 1, the upper surface of the substrate 1 is an operation surface, in other words, the operation surface of the substrate 1 is a surface on which the microneedles 3 protrude. A plurality of metal foils 2 extend in the width direction of the substrate 1 in parallel with each other, and a plurality of metal foils 2 are spaced apart in the longitudinal direction of the substrate 1. The metal foil 2 is completely embedded in the substrate 1 with an array of microneedles away from one edge of the substrate 1. The microneedle array comprises a plurality of microneedles 3 arranged at a certain pitch, the microneedles 3 projecting from the surface of the substrate 1 and Rather than it, the microneedle 3 forms an angle of 90 degrees with the surface of the substrate. The microneedles 3 are coplanar with the main surface on which the central portion of the foil 2 is located, and have a shape of a lower triangular upper triangular shape. The substrate 1 comprises a polymer. The metal foil 2 is made of stainless steel, and the microneedle array which protrudes outward at the edge of the metal foil 2 is formed by laser cutting, and the metal foil 2 forms an array of metal microneedles with the substrate 1 by injection molding.

In some embodiments, the foil 2 is completely embedded in the substrate 1, and only the tip 4 of the microneedle 3 protrudes from the operating surface of the substrate 1, as shown in FIG. In some embodiments, the metal foil 2 is embedded in the substrate 1, and the upper surface of the metal foil 2 is flush with the operating surface of the substrate 1, and the microneedles 3 all protrude from the operating surface of the substrate 1, as shown in FIG. In some embodiments, the foil 2 is partially embedded in the substrate 1, and the microneedles 3 all protrude from the operating surface of the substrate 1, as shown in FIG.

The microneedles 3 can have a variety of shapes and configurations. Referring to Figure 2, the shape of the microneedles 3 is a triangle. Preferably, the microneedles 3 have the shape of an isosceles triangle whose base is fixed to the upper edge of the foil 2. In some embodiments, the cross section of the microneedle 3 is a fold line or a smooth curve, as shown in FIG. In other words, the foil 2 and/or the microneedles 3 have grooves 7 and/or projections thereon. The groove 7 means that the microneedle 3 or the microneedle 3 is flat with one side surface of the metal foil 2 and the partial area of the other side surface is concave, or all of the both sides of the microneedle 3 or the microneedle 3 and the metal foil 2 Or part of the area is bent in a certain direction to form a concave structure as shown in FIG. The grooves and projections are formed by punching the surface of the metal foil 2 and the side of the microneedles 3, and correspondingly forming protrusions at the same position on the other side. Referring to Figure 4, in some embodiments, the needle tip 4 of the microneedle 3 is pointed. In other words, the needle tip 4 of the microneedle has its own anti-injection to prevent it from automatically The exiting spear tip structure, the spear tip structure includes a convex protrusion protruding from the side wall of the microneedle.

In some embodiments, the microneedles 3 can also have holes. The groove structure and/or the pores on the microneedles 3 are very advantageous for carrying more drugs, and can effectively prevent the drugs from falling out of the body during the process of breaking into the skin.

In some embodiments, the substrate 1 comprises at least one of plastic and rubber. As shown in Fig. 2, the substrate 1 has a rectangular parallelepiped shape composed of a plastic layer 110 at the bottom and a silicone rubber layer 120 at the upper portion. The elastic surface of the silicone rubber is suitable for close fitting to the skin, so that when the metal microneedle array of the embodiment of the present invention is used for cosmetic purposes, the user can feel more comfortable and more convenient. Advantageously, the substrate 1 is made of epoxy resin. In some embodiments, the substrate may be made of at least one of plastic, rubber, and at least one of metal, wood, ceramic, and glass.

In other words, the substrate 1 is suitably made of a plurality of materials, and may be preferably made of polymer, wood, metal, ceramic, glass, or may be composed of one or a combination of one of them. Polymers include plastics, composites of plastics and rubber, rubber, polyester and composites. For example, the substrate may be made of epoxy resin or polyester material, or a main body made of plastic such as polyethylene or polypropylene, and an epoxy resin is added to the fixed metal foil 2 to bond the related materials.

The substrate 1 may be composed of a flat or curved sheet or sheet, and may have various shapes such as a polygon, an arc, a circle, or a ring, as shown in Fig. 1-12. Alternatively, the substrate 1 may be composed of a plurality of flat or curved sheets which are held together by a plurality of metal sheets 2. Alternatively, the substrate 1 is composed of at least one hollow or solid polyhedron or curved body, which may take on various shapes such as a cylindrical shape or a drum shape. In some embodiments, the substrate 1 is cylindrical, i.e., has a circular cross section, as shown in FIG.

In some embodiments, the substrate 1 is provided with a positioning groove 5 in which the metal foil 2 is fixed, as shown in Figs. 7 and 8. It is to be understood that the locating grooves 5 can have a variety of different shapes and configurations, and the various structures shown in the drawings are merely for reference and exemplary, and should not be construed as limiting the invention.

Referring to Figures 7 and 8, the metal foil 2 is rectangular, and the substrate 1 is provided with a positioning groove 5, and a first longitudinal side (i.e., a bottom edge) of the metal foil 2 is fixed in the positioning groove 5, and the microneedle 3 is formed in the The second longitudinal side (ie, the top edge) of the foil 2 is described. It will be understood by those skilled in the art that the foil 7 shown in Fig. 7 is initially rectangular, the microneedles 3 are coplanar with the major surface of the foil 7, and the annular orientation of the foil 7 embedded in the substrate 1 After the groove 5, it is shown as a ring shape as shown in Fig. 7. As shown in FIG. 12, the thin metal 2 is annular, the substrate 1 is a columnar body having a through hole 8, and the metal foil 2 is fixed to the substrate 1 in the circumferential direction of the substrate as described above. On the outer peripheral surface of the operation surface, the plurality of metal foils 2 are arranged at an axial interval of the substrate. As shown in FIG. 15, the metal foil 2 is rectangular, and the metal foil 2 is fixed to the outer peripheral surface of the substrate 1 as the operation surface in the axial direction of the substrate 1, the plurality of metal foils. 2 are arranged along the circumferential spacing of the substrate.

In other words, the metal foil 2 can be designed in various shapes such as a straight strip shape, a circular arc shape, or a circular ring shape as needed. Advantageously, the foil 2 may have a thickness of from 1 to 800 microns. An array of positioning grooves 5 may be disposed on the substrate 1, and one side edge of the metal foil is embedded in the positioning groove 5. Depending on the design and fabrication process or equipment conditions, the shape of the rim region 14 of the foil 2 between the microneedles 3 can be of various shapes and is not limited to that shown in the drawings.

In some embodiments, the metal foil 2 may be attached to the substrate 1 by a fixing structure and/or an adhesive 6 such as epoxy or silicone rubber. Preferably, one side edge (for example, the bottom edge) of the metal foil 2 passes through the fixing structure and/or Or the adhesive 6 is fixed in the substrate 1, and the other side edge of the metal foil 2 is formed with a plurality of microneedles 3 which at least partially protrude from the operation surface of the substrate 1.

In some embodiments, referring to FIG. 9, a fixing groove 5 is formed in the operation surface of the substrate 1, and the lower edge of the metal foil 2 is fixed in the fixing groove 5 by the fixing structure and/or the adhesive 6, the microneedle 3 A portion protrudes from the operating surface of the substrate 1.

In some embodiments, the metal foil 2 has a major surface, the microneedle 3 being perpendicular to the major surface of the foil 2, as shown in Figures 10 and 11.

According to an embodiment of the invention, at least one edge of the metal foil 2 is formed with an array of microneedles. Referring to Figure 10, the left edge of the metal foil 2 is formed with an array of microneedles. Referring to Fig. 10, the left and right edges of the metal foil 2 are formed with an array of microneedles.

In some embodiments, the metal foil 2 may be formed by using various metal materials such as stainless steel and titanium alloys by laser cutting, electric spark cutting, chemical or electrochemical etching, stamping, and the like. The above methods are well known to those skilled in the art, and thus the specific preparation steps thereof will not be repeated herein. Advantageously, a gold film or a platinum film may be formed on the surface of the metal foil 2 by evaporation, sputtering or electroplating.

In some embodiments, the length of the microneedle 3 for the intrusion portion (eg, the length of the needle tip 4) may be 10-1500 microns, and the width of the microneedle 3 (eg, the width of the rectangle at the bottom of the microneedle) may be 10-1000. Micron.

In some embodiments, the metal microneedle array further includes an external lead (not shown) having an interface (not shown) that is coupled to the interface.

The metal microneedle array provided in this embodiment may also be referred to as a microneedle electrode array comprising the above metal microneedle array and an external lead connected to the metal foil 2. The side and/or the back of the metal microneedle array are provided with an interface to an external lead. The external leads can be connected to the interface by soldering, conductive adhesive bonding, and the like.

The microneedle electrode array of the embodiment of the present invention can not only effectively improve the signal-to-noise ratio of the biopotential detection, but also apply various electrical signals to the skin and perform related measurements. In addition, it is also possible to apply a transdermal patch on the microneedle electrode array, and apply the same or different electrical signal stimulation to each metal foil while the microneedle is administered transdermally, which is more advantageous for the passage of certain drugs. Skin transport to improve efficacy.

Preferably, the external wires have at least two, but no more than the number of metal foils 2. The different foils 2 can be set to be short-circuited or open as needed.

The following is a brief introduction to the use of the microneedle electrode array. First, the microneedle array is completely immersed in the skin, and then the back surface of the substrate 1 can be fixed to the skin surface around the microneedle electrode array with ordinary medical tape.

A microneedle transdermal patch of an embodiment of the present invention will be described below with reference to the accompanying drawings. As shown in Fig. 13, a microneedle transdermal patch according to an embodiment of the present invention includes the above-described metal microneedle array, a transdermal patch layer 15 coated on the microneedles, and a protective layer (not shown). A protective layer is applied over the microneedles for sealing and protecting the microneedles and the transdermal patch layer 15.

In other words, the microneedle transdermal patch according to an embodiment of the present invention includes a metal microneedle array, a transdermal patch and a protective film or a protective bag coated thereon.

The microneedle transdermal patch according to the embodiment of the present invention can increase the storage amount of each microneedle, the microneedle has a small invasive force and the carried drug is not easily peeled off, the drug effect is exerted rapidly, and the action time is longer. A transdermal patch contains one or more pharmaceutical ingredients or cosmetic skin care products having therapeutic, health or cosmetic effects. In some embodiments, the transdermal patch covers only the protruding microneedles or the needle tips in the array of metal microneedles. This not only saves the drug component, but also controls the amount of drug that enters the skin.

In some embodiments, the microneedles are provided with grooves and/or holes. The grooves and holes in the microneedles can be used not only to store more drugs, but also to make the administration time longer, and to effectively avoid the problem of the drug being detached from the body during the process of breaking into the skin.

The transdermal patch or cosmetic patch can be applied to the microneedle array or even the substrate by various conventional physical or chemical methods such as dipping, coating, fumigation, and deposition. The protective film or protective bag used has the function of sealing and protecting the microneedle and the transdermal patch covered thereon.

In the course of use, the microneedle array on the microneedle transdermal patch is first smashed into the skin, and then the patch can be fixed on the skin surface around the microneedle transdermal patch with ordinary medical tape.

The microneedle transdermal administration stamp (also referred to as a microneedle cosmetic seal) of an embodiment of the present invention will be described below with reference to the accompanying drawings. As shown in Figures 14 and 15, a microneedle transdermal administration stamp according to an embodiment of the present invention includes the above-described metal microneedle array, base 9 and protective cap 12. The substrate 1 of the metal microneedle array is fixed to the susceptor 9, and the protective cap 12 is connected to the susceptor 9 for sealing and protecting the microneedles 3 together with the susceptor 9.

In other words, the microneedle transdermal administration stamp or the microneedle cosmetic seal includes the above-described metal microneedle array, the base 9 and the protective cap 12. The metal microneedle array is permanently or detachably secured to one end of the base 9, and the other end of the base 9 has a handle structure 10 that is easily manipulated by hand. The protective cap 12 can be placed on the base to protect the microneedle from damage.

The microneedle transdermal administration stamp according to the embodiment of the present invention has a simple manufacturing process, low cost, good consistency of microneedles, and high flexibility in structure and application of the microneedle array.

In some embodiments, referring to Figure 14, a metal microneedle array is secured in the middle of one end of the base 9, and the base edge is provided with projections 11 to define the maximum penetration depth of the microneedles 3. The protective cap 12 is detachably provided on the projection 11 of the base 9 for sealing together with the base 9 to protect the metal microneedle array therein. The other end of the base 9 is provided with a handle 10 for the user to operate by hand, thereby making it more convenient for the user to use.

The base 9 and the protective cap 12 can be manufactured using conventional soft and/or hard materials such as polymers, glass, wood, metal, ceramics, composite materials, and the like, using mature processes such as injection molding and machining. The assembly and fixing manner of the base 9 and the protective cap 12 may be carried out by various methods known in the art such as bonding, movable structure fastening, and the like.

It will be understood by those skilled in the art that the structure of the metal microneedle array of the microneedle transdermally-printed seal according to the embodiment of the present invention, the shape and structure of the handle 10 and the protective cap 12 are not limited to those shown in FIG. The shapes and structures shown in the drawings are for reference only and should not be construed as limiting the invention.

When the microneedle percutaneous administration stamp of the embodiment of the present invention is used for administration, the microneedle of the microneedle may be firstly removed into the skin surface and then removed, and then the medicament or the cosmetic skin care product is coated. On the surface of the skin.

Another aspect of an embodiment of the present invention also provides a microneedle roller. As shown in FIG. 15, the microneedle roller of the embodiment of the present invention includes a metal microneedle array and a holder 13. The metal microneedle array has a cylindrical substrate 1 and a plurality of metal foils. A plurality of metal foils extend in the axial direction of the substrate 1 in parallel with each other, and are spaced apart in the circumferential direction of the substrate 1. The metal foil is completely embedded in the substrate 1, and an edge of the surface away from the substrate 1 is formed with an array of microneedles. The microneedle array includes a plurality of microneedles 3 arranged at a certain pitch, and the microneedles 3 partially protrude from the surface of the substrate 1. One end of the bracket 13 supports the substrate 1 as the axis of the roller, and the metal microneedle array is freely rotatable about the end of the bracket 13, and the other end of the bracket 13 has a handle structure 10 that is easy to handle by hand. The bracket 13 can be mass-produced using various materials and processes such as polymers and metals.

In some embodiments, the microneedle roller further includes a protective cap (not shown). A protective cap is placed over the bracket 13 to protect the microneedles.

In the description of the present invention, the terms "first" and "second" are used for descriptive purposes only, and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, features defining "first", "second" may include one or more of the features, either explicitly or implicitly.

In addition, "multiple" means two or more unless otherwise specifically or specifically limited.

In the description of the present specification, the description with reference to the terms "one embodiment", "some embodiments", "example", "specific example", or "some examples" and the like means a specific feature described in connection with the embodiment or example. A structure, material or feature is included in at least one embodiment or example of the invention. In the present specification, the schematic representation of the above terms does not necessarily mean the same embodiment or example. Furthermore, the particular features, structures, materials, or characteristics described may be combined in a suitable manner in any one or more embodiments or examples.

The above description is only a preferred embodiment of the present invention, and it should be noted that those skilled in the art can make several improvements and substitutions without departing from the technical principles of the present invention. It should also be considered as the scope of protection of the present invention.

Claims

claims

I. A metal microneedle array, characterized by including:

Substrate, the substrate is a solid plate, a solid column or a hollow column and has an operating surface, the operating surface is a plane or a curved surface; and

At least one metal sheet, the at least one metal sheet is fixed on the substrate, at least one edge of the metal sheet is integrally formed with a plurality of microneedles spaced apart from each other, the microneedle has a free end and is connected to the The fixed end connected to the metal sheet, the free end of the microneedle is configured as a needle tip, the metal sheet is embedded in the operating surface, and at least a part of the microneedle protrudes from the operating surface and is in contact with the operating surface. The surface is at a predetermined angle.

2. The metal microneedle array according to claim 1, wherein there are at least two metal flakes, and the at least two metal flakes are parallel to each other and spaced apart.

3. The metal microneedle array according to claim 1 or 2, characterized in that only the tips of the microneedles protrude from the operating surface.

4. The metal microneedle array according to any one of claims 1 to 3, characterized in that the metal sheet has a main surface, and the microneedles are perpendicular or coplanar to the main surface of the metal sheet.

5. The metal microneedle array according to any one of claims 1-4, wherein the substrate includes a polymer.

6. The metal microneedle array according to claim 5, wherein the substrate includes at least one of plastic and rubber.

7. The metal microneedle array according to claim 6, wherein the substrate is made of epoxy resin.

8. The metal microneedle array according to claim 6, wherein the substrate is made of at least one of plastic and rubber and at least one of metal, wood, ceramics and glass.

9. The metal microneedle array according to any one of claims 1 to 8, characterized in that a gold film or a platinum film is formed on the surface of the metal sheet by evaporation, sputtering or electroplating.

10. The metal microneedle array according to any one of claims 1 to 9, characterized in that the needle tip is in the shape of a spear point.

II. The metal microneedle array according to any one of claims 1 to 10, characterized in that the cross-section of the microneedles is in the shape of a broken line or a smooth curve.

12. The metal microneedle array according to any one of claims 1 to 11, wherein the substrate is provided with a positioning groove, and the metal sheet is fixed in the positioning groove.

13. The metal microneedle array according to any one of claims 1 to 12, wherein the metal sheet is rectangular, the substrate is provided with a positioning groove, and the first longitudinal side of the metal sheet is Fixed in the positioning groove, the microneedles are formed on the second longitudinal edge of the metal sheet.

14. The metal microneedle array according to any one of claims 1 to 12, characterized in that the metal sheet is annular, the substrate is columnar, and the metal sheet is along the circumferential direction of the substrate. Fixed on the outer peripheral surface of the substrate as the operating surface, the plurality of metal sheets are arranged at intervals along the axial direction of the substrate.

15. The metal microneedle array according to any one of claims 1 to 12, characterized in that the metal sheet is rectangular, the substrate is columnar, and the metal sheet is along the axial direction of the substrate. Fixed on the outer peripheral surface of the substrate as the operating surface, the plurality of metal sheets are arranged at intervals along the circumferential direction of the substrate.

16. The metal microneedle array according to any one of claims 1 to 15, characterized in that it also includes an external wire, an interface is provided on the metal sheet, and the external wire is connected to the interface.

17. A microneedle transdermal drug delivery patch, characterized by including:

The metal microneedle array according to any one of claims 1-16;

A transdermal patch layer having at least one therapeutic or cosmetic component, the transdermal patch layer being coated on the microneedles; and

A protective layer covering the microneedles for sealing and protecting the microneedles and the transdermal patch layer.

18. A microneedle transdermal drug delivery seal, characterized by including:

pedestal;

The metal microneedle array according to any one of claims 1-16, the substrate is fixed on the base; and

A protective cap, the protective cap is connected to the base and used to seal and protect the microneedles together with the base.