Soluble hollow microneedle, microneedle array chip and transdermal drug delivery patch

Abstract

A soluble hollow microneedle, a microneedle array chip and a transdermal drug delivery patch belonging to the technical field of medical apparatuses. The soluble hollow microneedle comprises a needle tip (11), a needle bar (12) and a hollow tube (13), wherein the needle tip (11) and the needle bar (12) are connected in the axial direction of the soluble hollow microneedle; a liquid flow channel for liquid drug circulation is formed in the hollow tube (13); the needle bar (12) and the needle tip (11) are wrapped around the outside of the hollow tube; and the needle tip (11) and at least part of the needle bar (12) are made of a biodegradable polymer. A hollow microneedle is combined with a soluble microneedle; after a microneedle punctures a human body, the needle tip (11) and at least part of the needle bar (12) are gradually dissolved in the human body, such that liquid drugs in the liquid flow channel are gradually released into the body; and as the needle tip (11) and the needle bar (12) first come into contact with the human body during use, the liquid flow channel in the hollow tube is prevented from being blocked during a puncturing process, and the risk of a needle hole being blocked is reduced. The length of the liquid flow channel in the soluble hollow microneedle is shorter than the lengths of conventional hollow microneedles, thereby enhancing the microneedle strength of the needle bar part, and reducing the risk of the microneedle being broken.

Description

Soluble hollow microneedles, microneedle array chips, and transdermal drug delivery patches

[0001] Cross-references

[0002] This application claims priority to Chinese patent application No. 202311020720X, filed on August 14, 2023, entitled “Soluble Hollow Microneedles, Microneedle Array Chips and Transdermal Drug Delivery Patches,” all disclosures of which are incorporated herein by reference in their entirety. Technical Field

[0003] The present invention relates to the technical field of medical equipment, and in particular to a soluble hollow microneedle, a microneedle array chip and a transdermal drug delivery patch. Background Art

[0004] Microneedles are a novel delivery system that enhances drug delivery and addresses issues associated with conventional formulations. Microneedles disrupt the skin's surface, creating micron-scale channels that deliver drugs or active ingredients directly to the epidermis for microcirculation. Currently, the main types of microneedles available on the market include solid microneedles, hollow microneedles, soluble microneedles, coated microneedles, and hydrogel microneedles. Solid microneedles offer high mechanical strength but are prone to breakage, posing a safety risk to patients. Hollow microneedles, while offering advantages in drug loading due to their hollow structure, can also regulate the release rate of drugs or active substances, enabling precise drug delivery. However, hollow microneedles are prone to clogging after puncturing the skin. The hollow structure of the needle tip results in a thin wall, resulting in insufficient mechanical strength, making it prone to breakage or failure to penetrate the skin, posing safety and usage risks. While coated or soluble microneedles offer enhanced safety and efficient drug delivery, their low drug loading capacity often makes them unsuitable for clinical application. Microneedle structure and material are key factors affecting effective skin penetration. Reasonable microneedle structure and materials can effectively improve the mechanical structure performance of microneedles, improve drug delivery efficiency, and increase safety and performance.

[0005] Chinese patent application CN201510465176.9, entitled "A Base-Type Microneedle Array and Its Preparation Method," proposes a soluble array microneedle with a microneedle base and a preparation method. Although the base-type microneedle of this invention can achieve drug loading on both the upper end and the base, a large drug loading capacity means an excessive number of microneedles. The drug loading capacity is still limited by the number of needles, and the drug loading capacity is limited. Moreover, when the skin is pierced, too many needle holes will be formed on the skin surface.

[0006] Chinese patent application 201010256734.8, entitled Hollow Microneedle Array Chip, Transdermal Drug Delivery Patch, Device and Manufacturing Method, proposes a hollow microneedle structure, which mainly includes a needle head and a needle rod, and the needle rod with a certain inclination angle is fixed to a backing plate; the microneedle has a hole on the side, and the structure is strong, low cost and high yield rate. However, there are still problems such as clogging of the needle hole and easy breakage of the needle tip during insertion.

[0007] Summary of the Invention

[0008] The present invention aims to solve at least one of the technical problems existing in the related art. To this end, the present invention proposes a soluble hollow microneedle to solve the problems of needle hole clogging and easy breakage of the needle tip during the insertion process of existing microneedles.

[0009] An embodiment of the second aspect of the present invention provides a microneedle array chip comprising the above-mentioned soluble hollow microneedles.

[0010] An embodiment of the third aspect of the present invention provides a transdermal drug delivery patch, comprising the above-mentioned transdermal drug delivery patch.

[0011] The soluble hollow microneedle according to an embodiment of the present invention comprises:

[0012] A needle tip and a needle shaft, wherein the needle tip and the needle shaft are connected along the axial direction of the soluble hollow microneedle;

[0013] A hollow tube, wherein a liquid flow channel for the circulation of liquid medicine is formed in the hollow tube, and the needle shaft and the needle tip are covered on the outside of the hollow tube;

[0014] Wherein, the needle tip and at least a portion of the needle shaft are made of biodegradable polymer materials.

[0015] According to the soluble hollow microneedle of an embodiment of the present invention, the soluble hollow microneedle further includes a needle seat, which is connected to the end of the needle shaft away from the needle tip, and the needle tip, the needle shaft and at least part of the needle seat are made of biodegradable polymer material.

[0016] According to the soluble hollow microneedle of an embodiment of the present invention, the hollow tube is a straight tube, or the hollow tube includes a straight tube section and a curved tube section, the curved tube section is arranged close to the needle tip, a first liquid flow channel is formed in the straight tube section, and a second liquid flow channel is formed in the curved tube section, and the angle between the central axis of the first liquid flow channel and the central axis of the second liquid flow channel ranges from 0° to 90°.

[0017] According to the soluble hollow microneedle of an embodiment of the present invention, the end of the hollow tube passes through the side end of the needle rod to form a liquid outlet, or the end of the hollow tube is sealed at the end of the needle rod to form a blind hole.

[0018] According to the soluble hollow microneedle of an embodiment of the present invention, the hollow tube is a columnar structure with a smooth outer surface, or the outer surface of the hollow tube is provided with a convex portion, or the outer surface of the hollow tube is provided with a concave portion.

[0019] According to the soluble hollow microneedle of an embodiment of the present invention, the outer wall of the hollow tube is provided with a threaded section, and the threaded section extends along the axial direction of the hollow tube.

[0020] According to the soluble hollow microneedle of an embodiment of the present invention, the diameter of the end of the needle shaft away from the needle tip is 100-400 μm, and the total length of the needle tip and the needle shaft is 200-1000 μm.

[0021] According to the soluble hollow microneedle of an embodiment of the present invention, the height of the hollow tube is 200-900 μm.

[0022] The microneedle array chip according to the second embodiment of the present invention comprises:

[0023] a base, wherein a receiving cavity suitable for receiving the liquid medicine is formed in the base;

[0024] and at least two soluble hollow microneedles as described above;

[0025] The soluble hollow microneedle is arranged on the base, and the accommodating cavity is connected to the liquid flow channel.

[0026] The transdermal drug delivery patch according to the third embodiment of the present invention comprises a transdermal patch and the above-mentioned microneedle array chip, wherein the transdermal patch covers the microneedle array chip, and the transdermal patch is composed of one or more layers of protective films containing one or more substances.

[0027] The above one or more technical solutions in the embodiments of the present invention have at least one of the following technical effects:

[0028] Embodiments of the present invention provide a soluble hollow microneedle, a microneedle array chip, and a transdermal drug delivery patch. The soluble hollow microneedle includes a needle tip, a needle shaft, and a hollow tube. The needle tip and the needle shaft are connected along the axis of the soluble hollow microneedle. A liquid flow channel for the circulation of liquid medicine is formed in the hollow tube, and the needle shaft and needle tip are coated on the outside of the hollow tube. The needle tip and at least a portion of the needle shaft are made of a biodegradable polymer material. The hollow microneedle is combined with the soluble microneedle, and a liquid flow channel for the circulation of liquid medicine is formed by providing a hollow tube. The outside of the hollow tube is coated with the needle tip and the needle shaft, and the needle tip and at least a portion of the needle shaft are made of a biodegradable polymer material. After the microneedle punctures the human body, the needle tip and at least a portion of the needle shaft gradually dissolve in the human body, allowing the liquid medicine in the liquid flow channel to be gradually released into the body. Because the needle tip and the needle shaft first contact the human skin during use, clogging of the liquid flow channel of the hollow tube during puncture is avoided, reducing the risk of needle hole clogging. Moreover, the length of the liquid flow channel of the soluble hollow microneedle is shorter than that of the traditional hollow microneedle, thereby increasing the strength of the microneedle at the needle shaft part, reducing the risk of the soluble hollow microneedle breaking, and enhancing the safety performance during use.

[0029] Additional aspects and advantages of the present invention will be set forth in part in the description which follows and, in part, will be obvious from the description which follows, or may be learned by practice of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] In order to more clearly illustrate the technical solutions in the embodiments of the present invention or related technologies, the following briefly introduces the drawings required for use in the embodiments or related technical descriptions. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0031] FIG1 is a schematic structural diagram of a soluble hollow microneedle according to an embodiment of the present invention;

[0032] FIG2 is a second schematic structural diagram of the soluble hollow microneedle provided in an embodiment of the present invention;

[0033] FIG3 is a third structural diagram of the soluble hollow microneedle provided in an embodiment of the present invention;

[0034] FIG4 is a fourth structural diagram of a soluble hollow microneedle provided in an embodiment of the present invention;

[0035] FIG5 is a schematic structural diagram of a hollow tube provided in an embodiment of the present invention;

[0036] FIG6 is a schematic cross-sectional view of a microneedle array chip provided in an embodiment of the present invention.

[0037] Reference numerals:

[0038] 1. Soluble hollow microneedle; 11. Needle tip; 12. Needle shaft; 13. Hollow tube; 14. Needle seat; 130. Liquid flow channel; 131. Straight tube section; 132. Bend section; 133. Raised portion; 134. Threaded section; 1311. First liquid flow channel; 1322. Second liquid flow channel; 120. Liquid outlet;

[0039] 2. Base; 20. Accommodation cavity. DETAILED DESCRIPTION

[0040] The following embodiments of the present invention are described in further detail with reference to the accompanying drawings and examples. The following examples are used to illustrate the present invention but are not intended to limit the scope of the present invention.

[0041] In the description of the embodiments of the present invention, it should be noted that the terms "center," "longitudinal," "lateral," "upper," "lower," "inner," and "outer," etc., indicating orientations or positional relationships, are based on the orientations or positional relationships shown in the accompanying drawings and are intended solely to facilitate the description of the embodiments of the present invention and to simplify the description. They do not indicate or imply that the devices or components referred to must have a specific orientation, be constructed, or operate in a specific orientation. Therefore, they should not be construed as limitations on the embodiments of the present invention. Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0042] In the description of the embodiments of the present invention, it should be noted that, unless otherwise specified or limited, the terms "connected" and "connection" should be understood in a broad sense. For example, they can refer to fixed connections, detachable connections, or integral connections; mechanical connections, electrical connections; and direct connections or indirect connections through an intermediary. Those skilled in the art will understand the specific meanings of the above terms in the embodiments of the present invention based on the specific circumstances.

[0043] In the embodiments of the present invention, unless otherwise expressly specified or limited, a first feature being "above" or "below" a second feature may mean that the first and second features are in direct contact, or that the first and second features are in indirect contact through an intermediate medium. Furthermore, a first feature being "above," "above," and "above" a second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is at a higher level than the second feature. A first feature being "below," "below," and "below" a second feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature is at a lower level than the second feature.

[0044] In the description of this specification, the reference terms "one embodiment", "some embodiments", "example", "specific example", or "some examples" mean that the specific features, structures, materials or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the embodiment of the present invention. In this specification, the schematic representations of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials or characteristics described can be combined in any one or more embodiments or examples in a suitable manner. In addition, those skilled in the art can combine and combine different embodiments or examples described in this specification and features of different embodiments or examples without contradiction.

[0045] An embodiment of one aspect of the present invention, as shown in Figures 1 to 6, provides a soluble hollow microneedle 1, a microneedle array chip, and a transdermal drug delivery patch. The soluble hollow microneedle 1 includes a needle tip 11, a needle shaft 12, and a hollow tube 13. The needle tip 11 and the needle shaft 12 are connected along the axial direction of the soluble hollow microneedle 1. A liquid flow channel 130 for the circulation of the drug solution is formed in the hollow tube 13, and the needle shaft 12 and the needle tip 11 are coated on the outside of the hollow tube 13. The needle tip 11 and at least a portion of the needle shaft 12 are made of biodegradable polymer material.

[0046] It can be understood that the soluble hollow microneedle 1 of this embodiment combines a hollow microneedle with a soluble microneedle, and forms a liquid flow channel 130 for the circulation of liquid medicine by providing a hollow tube 13. The outside of the hollow tube 13 is coated with a needle tip 11 and a needle rod 12, and the needle tip 11 and at least part of the needle rod 12 are made of biodegradable polymer materials. After the microneedle pierces the human body, the needle tip 11 and at least part of the needle rod 12 gradually dissolve in the human body, so that the liquid medicine in the liquid flow channel 130 is gradually released into the body. Since the needle tip 11 and the needle rod 12 first contact the human skin during use, the liquid flow channel 130 of the hollow tube 13 is avoided from being blocked during the puncture process, thereby reducing the risk of needle hole blockage.

[0047] Furthermore, compared with traditional soluble microneedles, the soluble hollow microneedle 1 of this embodiment has a hollow tube 13 provided inside, forming a liquid flow channel 130 for storing and circulating the drug solution, thereby increasing the drug loading capacity without changing the external dimensions of the microneedle. Compared with traditional hollow microneedles, it has the advantage of conveniently controlling the drug release rate, and is applicable to a wider variety of drugs, and can match a variety of drugs; the strength of the microneedle is increased by providing the hollow tube 13; at the same time, the length of the liquid flow channel 130 of the soluble hollow microneedle 1 of this embodiment is shorter than that of the traditional hollow microneedle, thereby increasing the strength of the microneedle at the needle shaft 12 part, reducing the risk of the soluble hollow microneedle 1 breaking, and enhancing the safety performance during use.

[0048] It should be noted that the needle tip 11 is made of a biodegradable polymer material, and the needle rod 12 is partially or entirely made of a biodegradable polymer material, and its matrix material includes but is not limited to sodium hyaluronate (HA), sodium carboxymethyl cellulose (CMC-Na), polyvinyl alcohol (PVA), polyvinyl pyrrolidone (PVP), chondroitin sulfate (CS), hydroxypropyl methylcellulose (HPMC), carbohydrate materials (such as maltose and trehalose), etc.; the preparation method of the microneedle includes but is not limited to solvent casting, photolithography, droplet air blowing, 3D printing, stretch lithography, hot pressing, micromolding and ultrasonic welding, etc., which can be selected according to actual use requirements and are not specifically limited in this embodiment.

[0049] Furthermore, drug components can be added to the biodegradable polymer material to further increase the drug loading capacity of the microneedle. In one embodiment, the needle tip 11 and a portion of the needle shaft 12 are made of a soluble material. After the microneedle punctures the human body, the needle tip 11 and a portion of the needle shaft 12 dissolve to partially expose the hollow tube 13 coated therein, facilitating the entry of the drug solution into the human body through the liquid flow channel 130. In another embodiment, the needle tip 11 and the needle shaft 12 are all made of a soluble material. That is, after the microneedle punctures the human body, the needle tip 11 and the needle shaft 12 completely dissolve, and at the same time, the hollow tube 13 is fully exposed, and the drug solution is supplied to the human body through the liquid flow channel 130.

[0050] It can be understood that, in some embodiments, as shown in Figure 3, the outer shell portion of the soluble hollow microneedle 1 is composed only of the needle shaft 12 and the needle tip 11. In other embodiments, as shown in Figures 1 and 2, the soluble hollow microneedle 1 also includes a needle seat 14, which is connected to the end of the needle shaft 12 away from the needle tip 11. The needle tip 11, the needle shaft 12 and at least part of the needle seat 14 are made of biodegradable polymer material.

[0051] In an optional embodiment, as shown in Figures 1 and 2, the cross-sectional area of ​​the needle seat 14, the needle shaft 12, and the needle tip 11 decreases along the direction from the needle seat 14 to the needle tip 11, so as to reduce the initial contact area between the microneedle and the skin, increase the pressure, and be more conducive to the microneedle penetrating the skin. Optionally, the success rate of microneedle penetrating the skin can be further improved by increasing the sharpness of the needle tip 11. Furthermore, along the direction from the needle seat 14 to the needle tip 11, the cross-sectional area of ​​the needle seat 14, the needle shaft 12, and the needle tip 11 decreases smoothly in a curved shape. When the soluble hollow microneedle 1 penetrates the human skin, the force exerted by the skin on the soluble hollow microneedle 1 is transmitted to the needle tip 11, the needle shaft 12, and the needle seat 14 in turn. The needle tip 11, the needle shaft 12, and the needle seat 14 can be integrally formed, and the cross-sectional area from the needle tip 11, the needle shaft 12 to the needle seat 14 changes smoothly, which reduces stress concentration, further reduces the risk of needle breakage, and improves safety in use.

[0052] It can be understood that in some embodiments, the needle seat 14, the needle shaft 12 and the needle tip 11 are all made of biodegradable polymer materials and can gradually dissolve after piercing the human body. In some embodiments, as shown in Figures 1, 2 and 4, the needle shaft 12, the needle tip 11 and part of the needle seat 14 are made of biodegradable polymer materials, so that the remaining insoluble part of the needle seat 14 can serve as a barrier to prevent the soluble hollow microneedle 1 from excessively extending into the skin, thereby preventing the soluble hollow microneedle 1 from penetrating deep into the human skin, especially subcutaneously, to avoid bleeding and pain.

[0053] According to one embodiment of the present invention, the hollow tube 13 is a straight tube, or the hollow tube 13 includes a straight tube section 131 and a curved tube section 132, the curved tube section 132 is arranged close to the needle tip 11, a first liquid flow channel 1311 is formed in the straight tube section 131, and a second liquid flow channel 1322 is formed in the curved tube section 132, and the angle between the central axis of the first liquid flow channel 1311 and the central axis of the second liquid flow channel 1322 ranges from 0° to 90°.

[0054] In some embodiments, as shown in Figures 3 and 4, the hollow tube 13 is a straight tube for ease of processing and manufacturing. In other embodiments, as shown in Figures 1 and 2, the hollow tube 13 is a curved tube with a certain inclination angle, consisting of a straight tube section 131 and a curved tube section 132, dividing the liquid flow channel 130 into a first liquid flow channel 1311 and a second liquid flow channel 1322, and the angle between the central axis of the first liquid flow channel 1311 and the central axis of the second liquid flow channel 1322 ranges from 0° to 90°, thereby diversifying the exit angle of the liquid medicine when it flows out of the second liquid flow channel 1322, changing the flow direction of the liquid medicine when it flows out, reducing the flow velocity of the liquid medicine, reducing the flow pressure of the liquid medicine, thereby reducing the probability of liquid seepage, and allowing the liquid medicine to flow better into the skin tissue. Optionally, the angle between the central axis of the first liquid flow channel 1311 and the central axis of the second liquid flow channel 1322 ranges from 20° to 70°.

[0055] According to one embodiment of the present invention, the end of the hollow tube 13 passes through the side end of the needle rod 12 to form a liquid outlet 120, or the end of the hollow tube 13 is sealed at the end of the needle rod 12 to form a blind hole.

[0056] In some embodiments, as shown in FIG2 , the end of the hollow tube 13 passes through the side of the needle rod 12, and a liquid outlet 120 is formed at the contact position between the hollow tube 13 and the needle rod 12 for the drug to flow out, so that after the soluble hollow microneedle 1 penetrates the human skin, the drug can directly flow out from the liquid outlet 120 and be released into the skin tissue; in other embodiments, as shown in FIG1 , the end of the hollow tube 13 is completely wrapped by the needle rod 12. After the soluble hollow microneedle 1 penetrates the human skin, it is necessary to wait for the needle tip 11 and the needle rod 12 to dissolve to a certain extent before the hollow tube 13 is exposed and the drug is released into the skin tissue, which facilitates the control of the drug release rate. The distance between the end of the hollow tube 13 and the outer wall of the needle rod 12 is adjusted according to the need of the drug release rate, which can also achieve the purpose of adjusting the drug release rate.

[0057] According to one embodiment of the present invention, the hollow tube 13 is a columnar structure with a smooth outer surface, or the outer surface of the hollow tube 13 is provided with a protrusion 133 , or the outer surface of the hollow tube 13 is provided with a recess.

[0058] It can be understood that the hollow tube 13 has a certain rigidity, which can provide a certain support for the soluble hollow microneedle 1, thereby improving the overall structural strength of the soluble hollow microneedle 1, reducing the risk of the soluble hollow microneedle 1 breaking, and enhancing safety performance during use.

[0059] In some embodiments, the hollow tube 13 is a columnar structure with a smooth outer surface, including but not limited to a cylinder, a truncated cone or a multi-prism, etc., which is convenient for manufacturing and processing; in other embodiments, as shown in FIG4 , the outer surface of the hollow tube 13 is designed to be uneven, for example, the outer surface of the hollow tube 13 is provided with a raised portion 133 or a recessed portion (not shown in the figure), or the raised portion 133 and the recessed portion can be provided at the same time, and the number of the raised portion 133 or the recessed portion can be multiple, and they can be uniformly or unevenly arranged along the axis direction of the hollow tube 13. This design increases the contact area between the hollow tube 13 and the needle tip 11 and the needle shaft 12 when the needle tip 11 and the needle shaft 12 are cast with a biodegradable polymer material, so that the combination of the hollow tube 13 and the needle tip 11 and the needle shaft 12 is more firmly, thereby improving the structural strength of the soluble hollow microneedle 1.

[0060] According to one embodiment of the present invention, as shown in FIG. 3 and FIG. 5 , the outer wall of the hollow tube 13 is provided with a threaded section 134 , and the threaded section 134 extends along the axial direction of the hollow tube 13 .

[0061] In this embodiment, a threaded section 134 is provided on the outer wall of the hollow tube 13 along the axial direction of the hollow tube 13, so that the combination of the hollow tube 13 and the needle tip 11 and the needle rod 12 is tighter and more uniform, which greatly increases the contact area between the hollow tube 13 and the needle tip 11 and the needle rod 12, improves the firmness of the combination between the outer wall of the hollow tube 13 and the needle tip 11 and the needle rod 12, reduces the risk of the needle tip 11 breaking and failing to pierce the skin due to stress concentration, and further improves the safety performance of use.

[0062] According to one embodiment of the present invention, the diameter of the end of the needle shaft 12 away from the needle tip 11 is 100-400 μm, and the total length of the needle tip 11 and the needle shaft 12 is 200-1000 μm.

[0063] Furthermore, in one embodiment of the present invention, the diameter of the end of the needle rod 12 away from the needle tip 11 is 150-250 μm, and the total length of the needle tip 11 and the needle rod 12 is 400-800 μm, which can be designed according to actual use requirements.

[0064] According to the soluble hollow microneedle 1 of the embodiment of the present invention, the height of the hollow tube 13 is 200-900 μm.

[0065] Furthermore, in one embodiment of the present invention, the height of the hollow tube 13 is 200-800 μm.

[0066] Another embodiment of the present invention provides a microneedle array chip, comprising a base 2 and at least two of the above-mentioned soluble hollow microneedles 1 , wherein the at least two soluble microneedles 1 are disposed on the surface of the base 2 .

[0067] In an optional embodiment, as shown in FIG6 , a receiving cavity 20 suitable for receiving liquid medicine is formed in the base 2 . The receiving cavity 20 is connected to the liquid flow channel 130 for supplying liquid medicine into the liquid flow channel 130 .

[0068] The base 2 can be any carrier that can carry the soluble hollow microneedle 1, or it can be a container for storing drugs. Its accommodating cavity 20 contains the drug solution. The base 2 can be integrally formed with the soluble hollow microneedle 1 or made separately. The soluble hollow microneedle 1 is fixed on the base 2 through the needle rod 12 or the needle seat 14.

[0069] In some embodiments, there are multiple soluble hollow microneedles 1, and the multiple soluble hollow microneedles 1 are arranged perpendicular to the base 2 or at a preset angle to the surface of the base 2. The multiple soluble hollow microneedles 1 can be evenly arranged or irregularly arranged at a preset spacing on the base 2, which is not specifically limited in this embodiment.

[0070] It is easy to understand that the liquid flow channel 130 in the embodiment of the present invention can be formed by the hollow tube 13 alone, or formed by the hollow tube 13 and the base 2 together, or formed by the hollow tube 13, the base 2 and part of the needle rod 12 or the entire needle rod 12, or formed by the hollow tube 13, the base 2, the needle rod 12 and part of the needle tip 11, and this embodiment is not specifically limited.

[0071] It is understandable that the soluble hollow microneedle 1 has the beneficial effects of the above embodiment, and the microneedle array chip also has the beneficial effects of the above embodiment, which will not be described in detail in this application.

[0072] Embodiment of another aspect of the present invention provides a kind of transdermal drug delivery patch, comprise transdermal patch and above-mentioned microneedle array chip, transdermal patch is made of the protective film that one or more materials are comprised by one or more layers, and transdermal patch covers the microneedle array chip.Alternatively, at least comprise a kind of natural or synthetic medicine with treatment, diagnosis or preventive effect or the natural or synthetic cosmetic skin care product with skin care, skin care, whitening effect in this material, it is solid, liquid, particulate, ointment, plaster, emulsifiable paste, colloid, sol, gel or wherein several mixture.Alternatively, microneedle array chip is pasted on the middle part of medical adhesive tape or adhesive tape, with the medical film material that is easy to peel off, cover adhesive tape or adhesive tape all the other glue area and microneedle array chip, to protect microneedles, patch and adhesive tape.Patch can be circular or elliptical or polygonal or other required shape, such as the shape that matches with application site, and present embodiment is not specifically limited.

[0073] It is understandable that the soluble hollow microneedles 1 and the microneedle array chip have the beneficial effects of the above embodiments, and the transdermal drug delivery patch also has the beneficial effects of the above embodiments, which will not be described in detail in this application.

[0074] An embodiment of the present invention provides a soluble hollow microneedle 1, a microneedle array chip, and a transdermal drug delivery patch. The soluble hollow microneedle 1 includes a needle tip 11, a needle shaft 12, and a hollow tube 13. The needle tip 11 and the needle shaft 12 are connected along the axial direction of the soluble hollow microneedle 1. A liquid flow channel 130 for the circulation of the drug solution is formed in the hollow tube 13, and the needle shaft 12 and the needle tip 11 are coated on the outside of the hollow tube 13. The needle tip 11 and at least part of the needle shaft 12 are made of biodegradable polymer material. The hollow microneedles are combined with soluble microneedles. A hollow tube 13 is provided to form a liquid flow channel 130 for the flow of liquid medicine. The hollow tube 13 is coated with a needle tip 11 and a needle shaft 12. The needle tip 11 and at least a portion of the needle shaft 12 are made of a biodegradable polymer material. After the microneedles penetrate the human body, the needle tip 11 and at least a portion of the needle shaft 12 gradually dissolve in the body, gradually releasing the liquid medicine in the liquid flow channel 130 into the body. Because the needle tip 11 and the needle shaft 12 first come into contact with the human skin during use, clogging of the liquid flow channel 130 in the hollow tube 13 during puncture is avoided, reducing the risk of needle hole clogging. Furthermore, the liquid flow channel 130 of the soluble hollow microneedle 1 is shorter than that of conventional hollow microneedles, thereby increasing the strength of the microneedle in the needle shaft 12 portion, reducing the risk of breakage of the soluble hollow microneedle 1, and enhancing safety during use.

[0075] Finally, it should be noted that the above embodiments are intended only to illustrate the technical solutions of the present invention and are not intended to limit the present invention. Although the present invention has been described in detail with reference to the embodiments, those skilled in the art should understand that they may modify the technical solutions described in the aforementioned embodiments or replace some of the technical features therein with equivalents; such modifications or replacements do not deviate from the spirit and scope of the technical solutions of the embodiments of the present invention and are therefore intended to be included within the scope of protection of this application. Industrial Applicability

[0076] The present invention provides a soluble hollow microneedle, a microneedle array chip, and a transdermal drug delivery patch. The soluble hollow microneedle includes a needle tip, a needle shaft, and a hollow tube. The needle tip and the needle shaft are connected along the axis of the soluble hollow microneedle. A liquid flow channel for the circulation of liquid medicine is formed in the hollow tube, and the needle shaft and the needle tip are coated on the outside of the hollow tube. The needle tip and at least a portion of the needle shaft are made of a biodegradable polymer material. The hollow microneedle is combined with the soluble microneedle. After the microneedle is punctured into the human body, the needle tip and at least a portion of the needle shaft gradually dissolve in the human body, allowing the liquid medicine in the liquid flow channel to be gradually released into the body. Since the needle tip and the needle shaft first contact the human body during use, the liquid flow channel of the hollow tube is avoided from being blocked during the puncture process, reducing the risk of needle hole blockage. In addition, the length of the liquid flow channel of the soluble hollow microneedle is shorter than that of the traditional hollow microneedle, which increases the strength of the microneedle in the needle shaft part and reduces the risk of microneedle breakage. It has good economic value and application prospects.

Claims

1. A soluble hollow microneedle, characterized in that: include: A needle tip (11) and a needle shaft (12), wherein the needle tip (11) and the needle shaft (12) are connected along the axial direction of the soluble hollow microneedle; A hollow tube (13), wherein a liquid flow channel (130) for the circulation of liquid medicine is formed in the hollow tube (13), and the needle rod (12) and the needle tip (11) are covered on the outside of the hollow tube (13); Wherein, the needle tip (11) and at least a portion of the needle shaft (12) are made of biodegradable polymer material.

2. The soluble hollow microneedle according to claim 1, characterized in that: The soluble hollow microneedle further comprises a needle seat (14), wherein the needle seat (14) is connected to an end of the needle shaft (12) away from the needle tip (11), and the needle tip (11), the needle shaft (12) and at least a portion of the needle seat (14) are made of a biodegradable polymer material.

3. The soluble hollow microneedle according to claim 1, characterized in that: The hollow tube (13) is a straight tube, or the hollow tube (13) comprises a straight tube section (131) and a curved tube section (132), wherein the curved tube section (132) is arranged close to the needle tip (11), a first liquid flow channel (1311) is formed in the straight tube section (131), and a second liquid flow channel (1322) is formed in the curved tube section (132), and an angle between a central axis of the first liquid flow channel (1311) and a central axis of the second liquid flow channel (1322) ranges from 0° to 90°.

4. The soluble hollow microneedle according to claim 3, characterized in that: The end of the hollow tube (13) passes through the side end of the needle rod (12) to form a liquid outlet (120), or the end of the hollow tube (13) is sealed at the end of the needle rod (12) to form a blind hole.

5. The soluble hollow microneedle according to claim 1, characterized in that: The hollow tube (13) is a columnar structure with a smooth outer surface, or the outer surface of the hollow tube (13) is provided with a protrusion (133), or the outer surface of the hollow tube (13) is provided with a recessed portion.

6. The soluble hollow microneedle according to claim 1, characterized in that: The outer wall of the hollow tube (13) is provided with a threaded section (134), and the threaded section (134) extends along the axial direction of the hollow tube (13).

7. The soluble hollow microneedle according to any one of claims 1 to 6, characterized in that: The diameter of the end of the needle rod (12) away from the needle tip (11) is 100-400 μm, and the total length of the needle tip (11) and the needle rod (12) is 200-1000 μm.

8. The soluble hollow microneedle according to any one of claims 1 to 6, characterized in that: The height of the hollow tube (13) is 200-900 μm.

9. A microneedle array chip, characterized in that: include: A base (2), wherein a receiving cavity (20) suitable for receiving a medicinal liquid is formed in the base (2); and at least two soluble hollow microneedles according to any one of claims 1 to 8; The soluble hollow microneedle is arranged on the base (2), and the accommodating cavity (20) is connected to the liquid flow channel (130).

10. A transdermal drug delivery patch, characterized in that: The invention comprises a transdermal patch and the microneedle array chip according to claim 9, wherein the transdermal patch covers the microneedle array chip, and the transdermal patch is composed of one or more layers of protective films containing one or more substances.

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