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

Abstract

This invention relates to the field of medical device technology, providing 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 needle shaft are connected axially along the soluble hollow microneedle. A liquid channel for drug flow is formed inside the hollow tube, and the needle shaft and needle tip cover 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. By combining the hollow microneedle with the soluble microneedle, after the microneedle is inserted into the human body, the needle tip and at least a portion of the needle shaft gradually dissolve in the body, allowing the drug in the liquid channel to be gradually released into the body. Because the needle tip and needle shaft come into contact with the human body first during use, blockage of the liquid channel in the hollow tube during puncture is avoided, reducing the risk of needle hole blockage. Furthermore, the length of the liquid channel in the soluble hollow microneedle is shorter than that of traditional hollow microneedles, increasing the strength of the needle shaft portion and reducing the risk of microneedle breakage.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a soluble hollow microneedle, a microneedle array chip, and a transdermal drug delivery patch. Background Technology

[0002] Microneedles are a novel drug delivery system that enhances drug delivery and addresses issues associated with conventional formulations. By disrupting the skin's surface, micron-sized channels are created, allowing drugs or active ingredients to be directly guided to the epidermis and participate in microcirculation. Currently available microneedles include solid microneedles, hollow microneedles, soluble microneedles, coated microneedles, and hydrogel microneedles. Solid microneedles have high mechanical strength but are prone to breakage, posing safety risks to patients. Hollow microneedles, while offering advantages in drug loading capacity due to their hollow structure, can also regulate the release rate of drugs or active substances for precise drug delivery. However, hollow microneedles are prone to clogging the puncture site after skin penetration, and the thin wall of the needle tip due to its hollow structure results in insufficient mechanical strength, leading to breakage or failure to penetrate the skin, posing safety and usability risks. While coated or soluble microneedles offer high safety and efficient drug delivery, their low drug loading capacity often fails to meet clinical needs. The structure and materials of the microneedle are the main factors affecting its effective skin penetration. A well-designed microneedle structure and materials can effectively improve the mechanical properties of microneedles, enhance drug delivery efficiency, and increase safety and usability.

[0003] 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 its preparation method. Although the base-type microneedle of this invention can achieve drug loading at 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. In addition, when the skin is punctured, too many needle holes will be formed on the skin surface.

[0004] Chinese patent application 201010256734.8, entitled "Hollow Microneedle Array Chip, Transdermal Drug Delivery Patch, Device and Manufacturing Method," proposes a hollow microneedle structure, mainly comprising a needle tip and a needle rod, with the needle rod fixed to a liner at a certain angle; the microneedle has an opening on its side, resulting in a robust structure, low cost, and high yield. However, it still suffers from problems such as clogging of the needle hole during insertion and easy breakage of the needle tip. Summary of the Invention

[0005] This invention aims to at least solve one of the technical problems existing in related technologies. To this end, this invention proposes a soluble hollow microneedle to solve the problems of needle hole blockage and needle tip breakage during the insertion process of existing microneedles.

[0006] A second aspect of the present invention provides a microneedle array chip comprising the aforementioned soluble hollow microneedles.

[0007] A third aspect of the present invention provides a transdermal drug delivery patch, comprising the transdermal drug delivery patch described above.

[0008] Soluble hollow microneedles according to embodiments of the present invention comprise:

[0009] A needle tip and a needle shaft, wherein the needle tip and the needle shaft are connected axially along the soluble hollow microneedle;

[0010] A hollow tube, wherein a liquid flow channel for the flow of medicine is formed inside the hollow tube, and the needle bar and the needle tip are covered outside the hollow tube;

[0011] The needle tip and at least a portion of the needle shaft are made of a biodegradable polymer material.

[0012] According to an embodiment of the present invention, the soluble hollow microneedle further includes a needle hub connected to the end of the needle shaft away from the needle tip, wherein the needle tip, the needle shaft, and at least a portion of the needle hub are made of a biodegradable polymer material.

[0013] According to an embodiment of the present invention, the soluble hollow microneedle is a straight tube, or the hollow tube includes a straight tube section and a bent tube section, the bent tube section is disposed close to the needle tip, a first liquid flow channel is formed in the straight tube section, a second liquid flow channel is formed in the bent 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 is in the range of 0° to 90°.

[0014] According to an embodiment of the present invention, in a soluble hollow microneedle, the end of the hollow tube extends from the side end of the needle rod to form a liquid outlet, or the end of the hollow tube is closed at the end of the needle rod to form a blind hole.

[0015] According to an embodiment of the present invention, the soluble hollow microneedle has a hollow tube that is a columnar structure with a smooth outer surface, or the outer surface of the hollow tube is provided with a protrusion, or the outer surface of the hollow tube is provided with a recess.

[0016] According to an embodiment of the present invention, the soluble hollow microneedle has a threaded section on the outer wall of the hollow tube, and the threaded section extends along the axial direction of the hollow tube.

[0017] According to an embodiment of the present invention, the diameter of the end of the needle rod away from the needle tip is 100-400 μm, and the total length of the needle tip and the needle rod is 200-1000 μm.

[0018] According to an embodiment of the present invention, the soluble hollow microneedle has a hollow tube with a height of 200-900 μm.

[0019] According to a second aspect of the present invention, a microneedle array chip includes:

[0020] A base, wherein a receiving cavity suitable for containing liquid medicine is formed within the base;

[0021] and at least two soluble hollow microneedles as described above;

[0022] The soluble hollow microneedles are disposed on the base, and the receiving cavity is connected to the liquid flow channel.

[0023] According to a third aspect of the present invention, a transdermal drug delivery patch includes a transdermal patch and the microneedle array chip described above, wherein the transdermal patch covers the microneedle array chip, and the transdermal patch is composed of one or more protective films containing one or more substances.

[0024] The above-described one or more technical solutions in the embodiments of the present invention have at least one of the following technical effects:

[0025] 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 needle shaft are connected axially along the soluble hollow microneedle. A liquid channel for drug flow is formed inside the hollow tube, and the needle shaft and needle tip cover 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. By combining the hollow microneedle with the soluble microneedle, a liquid channel for drug flow is formed by the hollow tube. The needle tip and needle shaft are covered outside the hollow tube, and the needle tip and at least a portion of the needle shaft are made of a biodegradable polymer material. After the microneedle is inserted into the human body, the needle tip and at least a portion of the needle shaft gradually dissolve in the body, allowing the drug in the liquid channel to be gradually released into the body. Because the needle tip and needle shaft come into contact with the skin first during use, blockage of the liquid channel in the hollow tube during puncture is avoided, reducing the risk of needle hole blockage. Furthermore, the length of the liquid flow channel in soluble hollow microneedles is shorter than that of traditional hollow microneedles, thereby increasing the strength of the microneedle in the needle shaft, reducing the risk of breakage of soluble hollow microneedles, and enhancing safety performance during use.

[0026] Additional aspects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. Attached Figure Description

[0027] To more clearly illustrate the technical solutions in the embodiments of the present invention or related technologies, the drawings used in the description of the embodiments or related technologies will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0028] Figure 1 This is a schematic diagram of the structure of the soluble hollow microneedles provided in the embodiments of the present invention. Figure 1 ;

[0029] Figure 2 This is a schematic diagram of the structure of the soluble hollow microneedles provided in the embodiments of the present invention. Figure 2 ;

[0030] Figure 3 This is a schematic diagram of the structure of the soluble hollow microneedles provided in the embodiments of the present invention. Figure 3 ;

[0031] Figure 4 This is a schematic diagram of the structure of the soluble hollow microneedles provided in the embodiments of the present invention. Figure 4 ;

[0032] Figure 5 This is a schematic diagram of the hollow tube structure provided in an embodiment of the present invention;

[0033] Figure 6 This is a cross-sectional schematic diagram of the microneedle array chip provided in an embodiment of the present invention.

[0034] Figure label:

[0035] 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. Protrusion; 134. Threaded section; 1311. First liquid flow channel; 1322. Second liquid flow channel; 120. Liquid outlet;

[0036] 2. Base; 20. Receiving cavity. Detailed Implementation

[0037] The embodiments of the present invention will be described in further detail below with reference to the accompanying drawings and examples. The following examples are for illustrative purposes only and should not be construed as limiting the scope of the invention.

[0038] 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., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing the embodiments of the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the embodiments of the present invention. In addition, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0039] In the description of the embodiments of the present invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "connected" and "linked" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium. Those skilled in the art can understand the specific meaning of the above terms in the embodiments of the present invention based on the specific circumstances.

[0040] In embodiments of the present invention, unless otherwise explicitly specified and limited, "above" or "below" the second feature can mean that the first feature is in direct contact with the second feature, or that the first feature is in indirect contact with the second feature through an intermediate medium. Furthermore, "above," "over," and "on top" of the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply indicates that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply indicates that the first feature is at a lower horizontal level than the second feature.

[0041] In the description of this specification, the references to terms such as "one embodiment," "some embodiments," "example," "specific example," or "some examples," etc., refer to specific features, structures, materials, or characteristics described in connection with that embodiment or example, which are included in at least one embodiment or example of the present invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples. Moreover, without contradiction, those skilled in the art can combine and integrate the different embodiments or examples described in this specification, as well as the features of different embodiments or examples.

[0042] One embodiment of the present invention, in conjunction with Figures 1 to 6As shown in the embodiment of the present invention, a soluble hollow microneedle 1, a microneedle array chip, and a transdermal drug delivery patch are provided. The soluble hollow microneedle 1 includes a needle tip 11, a needle rod 12, and a hollow tube 13. The needle tip 11 and the needle rod 12 are connected along the axial direction of the soluble hollow microneedle 1. A liquid flow channel 130 for drug flow is formed inside the hollow tube 13, and the needle rod 12 and the needle tip 11 are covered outside the hollow tube 13. The needle tip 11 and at least part of the needle rod 12 are made of biodegradable polymer material.

[0043] It is understood that the soluble hollow microneedle 1 in this embodiment combines hollow microneedles with soluble microneedles. By setting a hollow tube 13, a liquid flow channel 130 for drug flow is formed. The hollow tube 13 is covered with a needle tip 11 and a needle rod 12. The needle tip 11 and at least part of the needle rod 12 are made of biodegradable polymer material. After the microneedle is inserted into 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 drug in the liquid flow channel 130 is gradually released into the body. Since the needle tip 11 and the needle rod 12 come into contact with the human skin first during use, the blockage of the liquid flow channel 130 of the hollow tube 13 during the puncture process is avoided, reducing the risk of needle blockage.

[0044] Furthermore, compared with traditional soluble microneedles, the soluble hollow microneedle 1 of this embodiment has an internal hollow tube 13, forming a liquid flow channel 130 for drug storage and flow. This increases the drug loading capacity without changing the external dimensions of the microneedle. Compared with traditional hollow microneedles, it has the advantage of convenient control of drug release rate and is applicable to a wider range of drugs, and can be matched with multiple drugs. The hollow tube 13 increases the strength of the microneedle. 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 traditional hollow microneedles, thereby increasing the strength of the microneedle in the needle shaft 12, reducing the risk of needle breakage, and enhancing the safety performance during use.

[0045] It should be noted that the needle tip 11 is made of a biodegradable polymer material, and the needle shaft 12 is partially or entirely made of a biodegradable polymer material. The matrix material includes, but is not limited to, sodium hyaluronate (HA), sodium carboxymethyl cellulose (CMC-Na), polyvinyl alcohol (PVA), polyvinylpyrrolidone (PVP), chondroitin sulfate (CS), hydroxypropyl methylcellulose (HPMC), and carbohydrate materials (such as maltose and trehalose). The preparation methods of the microneedles include, but are not limited to, solvent casting, photolithography, droplet air blowing, 3D printing, stretch lithography, hot pressing, micromolding, and ultrasonic welding. The method can be selected according to the actual use requirements, and this embodiment does not make specific limitations.

[0046] Furthermore, drug components can be added to biodegradable polymer materials to further increase the drug loading capacity of microneedles. In one embodiment, the needle tip 11 and part of the needle shaft 12 are made of soluble material. After the microneedle is inserted into the human body, the needle tip 11 and part of the needle shaft 12 dissolve to partially expose the hollow tube 13 encapsulated therein, facilitating the entry of the drug solution into the human body through the liquid flow channel 130. In another embodiment, both the needle tip 11 and the needle shaft 12 are made entirely of soluble material. That is, after the microneedle is inserted into the human body, the needle tip 11 and the needle shaft 12 completely dissolve, while fully exposing the hollow tube 13, allowing the drug solution to be supplied to the human body through the liquid flow channel 130.

[0047] It is understood that in some embodiments, such as Figure 3 As shown, the outer shell of the soluble hollow microneedle 1 consists only of the needle shaft 12 and the needle tip 11. In other embodiments, such as... Figure 1 and Figure 2 As shown, the soluble hollow microneedle 1 also includes a needle seat 14, which is connected to the end of the needle bar 12 away from the needle tip 11. The needle tip 11, the needle bar 12 and at least part of the needle seat 14 are made of biodegradable polymer material.

[0048] In one alternative implementation, such as Figure 1 and Figure 2 As shown, along the direction from the needle base 14 to the needle tip 11, the cross-sectional area of ​​the needle base 14, needle shank 12, and needle tip 11 decreases progressively to reduce the initial contact area between the microneedle and the skin, increase pressure, and facilitate microneedle insertion into the skin. Optionally, the success rate of microneedle insertion into the skin can be further improved by increasing the sharpness of the needle tip 11. Furthermore, along the direction from the needle base 14 to the needle tip 11, the cross-sectional area of ​​the needle base 14, needle shank 12, and needle tip 11 decreases smoothly with a curved surface. When the soluble hollow microneedle 1 punctures human skin, the force exerted by the skin on the soluble hollow microneedle 1 is sequentially transmitted to the needle tip 11, needle shank 12, and needle base 14. The needle tip 11, needle shank 12, and needle base 14 can be integrally molded, and the gradual change in cross-sectional area from the needle tip 11, needle shank 12 to the needle base 14 reduces stress concentration, further reduces the risk of needle breakage, and improves safety in use.

[0049] It is understood that in some embodiments, the needle hub 14, needle shaft 12, and needle tip 11 are all made of biodegradable polymer materials, which can gradually dissolve after being inserted into the human body. In some embodiments, such as Figure 1 , Figure 2 and Figure 4As shown, the needle shaft 12, needle tip 11, and part of the needle hub 14 are made of biodegradable polymer material. In this way, the remaining insoluble part of the needle hub 14 can act as a barrier to prevent the soluble hollow microneedle 1 from penetrating too deeply into the skin, thus avoiding the soluble hollow microneedle 1 from piercing the deep layers of the skin, especially the subcutaneous layer, and preventing bleeding and pain.

[0050] 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 bent tube section 132. The bent tube section 132 is disposed near 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 bent tube section 132. The angle between the central axis of the first liquid flow channel 1311 and the central axis of the second liquid flow channel 1322 is in the range of 0° to 90°.

[0051] In some implementations, such as Figure 3 and Figure 4 As shown, the hollow tube 13 is a straight tube, which facilitates processing and manufacturing. In other embodiments, such as... Figure 1 and Figure 2 As shown, the hollow tube 13 is a curved tube with a certain inclination angle, consisting of a straight section 131 and a curved section 132, dividing the liquid flow channel 130 into a first liquid flow channel 1311 and a second liquid flow channel 1322. 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°, which diversifies the exit angle of the liquid when it flows out of the second liquid flow channel 1322, changes the flow direction of the liquid, reduces the flow velocity and pressure of the liquid, thereby reducing the probability of exudation and allowing the liquid to flow into the skin tissue better. 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°.

[0052] According to one embodiment of the present invention, the end of the hollow tube 13 extends from the side end of the needle bar 12 to form a liquid outlet 120, or the end of the hollow tube 13 is closed at the end of the needle bar 12 to form a blind hole.

[0053] In some embodiments, such as Figure 2 As shown, the end of the hollow tube 13 extends from 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 solution to flow out. This allows the drug solution to flow directly out from the liquid outlet 120 and be released into the skin tissue after the soluble hollow microneedle 1 punctures the human skin; in other embodiments, such as Figure 1As shown, the end of the hollow tube 13 is completely wrapped by the needle rod 12. After the soluble hollow microneedle 1 is punctured into the human skin, the hollow tube 13 is exposed only after the needle tip 11 and the needle rod 12 have dissolved to a certain extent. Only then is the drug released into the skin tissue, which makes it convenient to control the release rate of the drug. The distance between the end of the hollow tube 13 and the outer wall of the needle rod 12 can also be adjusted according to the needs of the drug release rate to achieve the purpose of adjusting the drug release rate.

[0054] 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.

[0055] Understandably, the hollow tube 13 has a certain rigidity, which can provide some support for the soluble hollow microneedle 1, improve the overall structural strength of the soluble hollow microneedle 1, reduce the risk of breakage of the soluble hollow microneedle 1, and enhance the safety performance during use.

[0056] In some embodiments, the hollow tube 13 is a columnar structure with a smooth outer surface, including but not limited to a cylinder, frustum, or polygonal prism, which facilitates manufacturing and processing; in other embodiments, such as Figure 4 As shown, the outer surface of the hollow tube 13 is designed with an uneven shape. For example, the outer surface of the hollow tube 13 may have protrusions 133 or recesses (not shown in the figure), or both protrusions 133 and recesses may be provided simultaneously. There may be multiple protrusions 133 or recesses, and they may be evenly or unevenly distributed along the axial direction of the hollow tube 13. This design increases the contact area between the hollow tube 13 and the needle tip 11 and needle rod 12 when the needle tip 11 and needle rod 12 are cast with biodegradable polymer materials, making the bond between the hollow tube 13 and the needle tip 11 and needle rod 12 stronger and improving the structural strength of the soluble hollow microneedle 1.

[0057] According to one embodiment of the present invention, such as Figure 3 and Figure 5 As shown, the outer wall of the hollow tube 13 is provided with a threaded section 134, which extends along the axial direction of the hollow tube 13.

[0058] 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, which makes the connection between the hollow tube 13 and the needle tip 11 and the needle rod 12 tighter and more uniform, greatly increasing the contact area between the hollow tube 13 and the needle tip 11 and the needle rod 12, improving the bonding strength between the outer wall of the hollow tube 13 and the needle tip 11 and the needle rod 12, reducing the risk of needle tip 11 breakage and failure to pierce the skin due to stress concentration, and further improving the safety performance.

[0059] According to one embodiment of the present invention, the diameter of the end of the needle bar 12 away from the needle tip 11 is 100-400 μm, and the total length of the needle tip 11 and the needle bar 12 is 200-1000 μm.

[0060] Furthermore, in one embodiment of the present invention, the diameter of the end of the needle bar 12 away from the needle tip 11 is 150-250μm, and the total length of the needle tip 11 and the needle bar 12 is 400-800μm, which can be designed according to actual usage requirements.

[0061] According to an embodiment of the present invention, the soluble hollow microneedle 1 has a hollow tube 13 with a height of 200-900 μm.

[0062] Furthermore, in one embodiment of the present invention, the height of the hollow tube 13 is 200-800 μm.

[0063] In another embodiment of the present invention, a microneedle array chip is provided, including a base 2 and at least two of the above-described soluble hollow microneedles 1, wherein the at least two soluble microneedles 1 are disposed on the surface of the base 2.

[0064] In one alternative implementation, such as Figure 6 As shown, a receiving cavity 20 suitable for containing liquid medicine is formed in the base 2. The receiving cavity 20 is connected to the liquid flow channel 130 and is used to supply liquid medicine into the liquid flow channel 130.

[0065] The base 2 can be any carrier capable of supporting the soluble hollow microneedles 1, or it can be a container for storing drugs. Its cavity 20 contains the drug solution. The base 2 can be integrally formed with the soluble hollow microneedles 1 or made separately. The soluble hollow microneedles 1 are fixed to the base 2 by the needle rod 12 or the needle seat 14.

[0066] In some embodiments, the number of soluble hollow microneedles 1 is multiple. 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 arranged uniformly or irregularly on the base 2 at a preset interval. This embodiment does not make specific limitations.

[0067] It is readily understood that the liquid flow channel 130 in this embodiment of the invention may be formed by the hollow tube 13 alone, or by the hollow tube 13 and the base 2 together, or by the hollow tube 13, the base 2 and part or all of the needle bar 12, or by the hollow tube 13, the base 2, the needle bar 12 and part of the needle tip 11. This embodiment does not make specific limitations.

[0068] It is understood that if the soluble hollow microneedles 1 have the beneficial effects of the above embodiments, then the microneedle array chip also has the beneficial effects of the above embodiments, which will not be elaborated upon in this application.

[0069] In another embodiment of the present invention, a transdermal drug delivery patch is provided, comprising a transdermal patch and the aforementioned microneedle array chip. The transdermal patch consists of one or more protective films containing one or more substances, and the transdermal patch covers the microneedle array chip. Optionally, the substance comprises at least one natural or synthetic drug with therapeutic, diagnostic, or preventative effects, or a natural or synthetic cosmetic skincare product with skin-care, beautifying, or whitening effects, which is a solid, liquid, microparticle, ointment, plaster, cream, colloid, sol, gel, or a mixture thereof. Optionally, the microneedle array chip is adhered to the center of a medical adhesive tape or plaster, and the remaining adhesive area of ​​the tape or plaster and the microneedle array chip are covered with an easily peelable medical film material to protect the microneedles, patch, and tape. The patch can be circular, elliptical, polygonal, or other desired shapes, such as shapes that conform to the application site; this embodiment does not impose specific limitations.

[0070] It is understood that since the soluble hollow microneedles 1 and the microneedle array chip have the beneficial effects of the above embodiments, the transdermal drug delivery patch also has the beneficial effects of the above embodiments, which will not be elaborated upon in this application.

[0071] 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 drug flow is formed inside the hollow tube 13, and the needle shaft 12 and the needle tip 11 are covered outside the hollow tube 13. The needle tip 11 and at least a portion of the needle shaft 12 are made of a biodegradable polymer material. By combining hollow microneedles with soluble microneedles, a liquid flow channel 130 for drug delivery is formed through a hollow tube 13. The hollow tube 13 is externally covered with a needle tip 11 and a needle shaft 12, and the needle tip 11 and at least part of the needle shaft 12 are made of biodegradable polymer material. After the microneedle is inserted into the human body, the needle tip 11 and at least part of the needle shaft 12 gradually dissolve in the body, allowing the drug in the liquid flow channel 130 to be gradually released into the body. Because the needle tip 11 and needle shaft 12 come into contact with the human skin first during use, blockage of the liquid flow channel 130 in the hollow tube 13 is avoided during puncture, reducing the risk of needle hole blockage. Furthermore, the length of the liquid flow channel 130 of the soluble hollow microneedle 1 is shorter than that of traditional hollow microneedles, thereby increasing the strength of the microneedle in the needle shaft 12 portion, reducing the risk of needle breakage, and enhancing the safety performance during use.

[0072] Finally, it should be noted that the above embodiments are only used 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 modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention, and should all be included within the protection scope of this application.

Claims

1. A soluble hollow microneedle, characterized by, include: A needle tip (11) and a needle bar (12), wherein the needle tip (11) and the needle bar (12) are connected along the axial direction of the soluble hollow microneedle; Hollow tube (13), a liquid flow channel (130) for drug flow is formed inside the hollow tube (13), and the needle rod (12) and the needle tip (11) are covered outside the hollow tube (13); The needle tip (11) and at least a portion of the needle shaft (12) are made of biodegradable polymer material; The outer wall of the hollow tube (13) is provided with a threaded section (134), which extends along the axial direction of the hollow tube (13). The end of the hollow tube (13) passes through the side end of the needle rod (12) to form a liquid outlet (120). The liquid outlet (120) at the end of the hollow tube (13) is completely wrapped by the needle rod (12). After the soluble hollow microneedle is punctured into 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 liquid outlet (120) at the end of the hollow tube (13) is exposed, and the drug solution is released into the skin tissue. The hollow tube (13) includes a straight section (131) and a bent section (132). The bent section (132) is located close to the needle tip (11). A first liquid flow channel (1311) is formed in the straight section (131), and a second liquid flow channel (1322) is formed in the bent section (132). The angle between the central axis of the first liquid flow channel (1311) and the central axis of the second liquid flow channel (1322) is in the range of 20° to 70°.

2. The soluble hollow microneedles according to claim 1, characterized in that, The soluble hollow microneedle also includes a needle seat (14), which is connected to the end of the needle bar (12) away from the needle tip (11). The needle tip (11), the needle bar (12) and at least part of the needle seat (14) are made of biodegradable polymer material.

3. The soluble hollow microneedles 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 recess.

4. The soluble hollow microneedles according to any one of claims 1 to 3, characterized in that, The diameter of the end of the needle bar (12) away from the needle tip (11) is 100-400μm, and the total length of the needle tip (11) and the needle bar (12) is 200-1000μm.

5. The soluble hollow microneedles according to any one of claims 1 to 3, characterized in that, The height of the hollow tube (13) is 200-900μm.

6. A microneedle array chip, characterized in that, include: The base (2) has a cavity (20) formed inside the base (2) that is suitable for containing the liquid medicine; and at least two soluble hollow microneedles as described in any one of claims 1-5; The soluble hollow microneedles are disposed on the base (2), and the receiving cavity (20) is connected to the liquid flow channel (130).

7. A transdermal drug delivery patch, characterized in that, The invention includes a transdermal patch and the microneedle array chip of claim 6, wherein the transdermal patch covers the microneedle array chip, and the transdermal patch consists of one or more protective films containing one or more substances.

Images