Microneedle and transdermal drug delivery device

Abstract

The utility model discloses a microneedle and transdermal drug delivery device, the microneedle comprises: an integrated needle seat, the needle seat comprises a cover body with an opening at one end, a connecting part connected with the cover body and provided with a first injection channel, and at least one support table arranged in the cover body, a negative pressure cavity is enclosed between the cover body and the support table, and the negative pressure cavity is provided with a first injection channel; a negative pressure opening communicated with the negative pressure cavity is formed in the cover body; the microchip comprises a base part and a plurality of hollow needle heads loaded on the base part, the base part is fixed at the tail end of the supporting table, the needle heads are communicated with the first injection channel, and the tail ends of the needle heads do not protrude out of the opening of the cover body. The needle base is integrally formed, transdermal penetration can be directly achieved in the negative pressure process, a structure for additionally pushing the needle head to move is not needed, the overall structure is simple, cost is low, and the service life is long.

Description

Technical Field

[0001] This utility model belongs to the field of medical device technology, specifically relating to a microneedle and transdermal drug delivery device. Background Technology

[0002] Microneedling devices are one type of skin beauty device. They use microneedles to pierce the skin's surface and create multiple tiny channels, allowing the active ingredients of skin nutrients to penetrate the skin through these channels, thereby promoting the skin's absorption of beauty products.

[0003] Existing microneedling devices mainly include roller-type and single-needle-type devices. Roller-type devices have disadvantages such as complicated operation, bleeding, and pain, and also pose a potential risk of bacterial infection. Single-needle devices have difficulty ensuring consistent injection depth, and this inconsistency can easily cause adverse reactions such as swelling, redness, and nodules. As for multi-needle microcrystalline heads, due to the need to move the needles, the needle hub usually requires multiple components for assembly, resulting in a complex structure and a short lifespan.

[0004] The information disclosed in this background section is intended only to enhance the understanding of the overall background of this utility model and should not be construed as an admission or in any way implying that the information constitutes prior art known to those skilled in the art. Utility Model Content

[0005] The purpose of this invention is to provide a microneedle and transdermal drug delivery device that addresses the problems of complex needle hub structure and short service life in existing technologies.

[0006] To achieve the above objectives, the technical solution provided by a specific embodiment of this utility model is as follows:

[0007] A microneedle, comprising:

[0008] An integrally formed needle holder includes a cover with one end open, a connecting part connected to the cover and having a first injection channel, and at least one support platform disposed in the cover. A negative pressure cavity is formed between the cover and the support platform, and a negative pressure port communicating with the negative pressure cavity is opened on the cover.

[0009] The microchip includes a base and a plurality of hollow needles mounted on the base. The base is fixed to the end of the support platform. The needles are in communication with the first injection channel and the ends of the needles do not protrude from the opening of the cover.

[0010] In one or more embodiments of this utility model, the cover is provided with at least one groove extending toward the opening of the cover, and a slider that can approach or move away from the opening of the cover is provided in the groove. The end of the slider facing the opening of the cover is loaded with pigment, and the end of the slider away from the opening of the cover is connected to the cover with a tension spring. The end of the groove near the opening of the cover is connected to a negative pressure chamber. Under negative pressure, the end of the slider with pigment can move to the opening of the cover.

[0011] In one or more embodiments of this utility model, the groove is arranged circumferentially around the cover, or the groove is arranged along part or all of the edges of the cover.

[0012] In one or more embodiments of the present invention, the end of the support platform is recessed with a groove communicating with the first injection channel, and the base is fitted and limited in the groove.

[0013] In one or more embodiments of this utility model, a guide hole communicating with the card slot is provided at the top corner of the card slot.

[0014] In one or more embodiments of this utility model, the end of the support platform does not protrude beyond the opening of the cover, and the height difference between the end of the support platform and the opening of the cover is 50μm-500μm, or 100μm-400μm, or 200μm-350μm, or 250μm-350μm.

[0015] In one or more embodiments of this utility model, a plurality of support platforms are arranged side by side inside the cover, and each support platform has a second injection channel communicating between the first injection channel and the needle.

[0016] In one or more embodiments of this utility model, a plurality of the support platforms are spaced apart at one end near the opening of the cover.

[0017] In one or more embodiments of this invention, the microcrystalline head is made of silicon or other biocompatible hard materials.

[0018] To achieve the above objectives, a specific embodiment of this utility model also provides a transdermal drug delivery device.

[0019] include:

[0020] The aforementioned microneedles;

[0021] The drug delivery device mates with the connecting part;

[0022] A negative pressure device, which is used in conjunction with the negative pressure port.

[0023] Compared with the prior art, the advantages of this utility model include at least the following:

[0024] (1) The needle seat of this utility model is integrally molded, which can directly achieve transdermal penetration during negative pressure process without the need for an additional structure to push the needle to move. The overall structure is simple, low in cost, and has a long service life.

[0025] (2) The microchip of this utility model is formed by processing a wafer using semiconductor technology. The resulting needle-like structure does not cause bleeding or pain when transdermal.

[0026] (3) This utility model uses a slider loaded with pigment to form a color mark around the drug delivery area when working under negative pressure, thus avoiding repeated drug delivery in the same area. Attached Figure Description

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

[0028] Figure 1 This is a three-dimensional structural diagram of the needle holder in the first embodiment of the present invention;

[0029] Figure 2 This is a three-dimensional structural diagram of a needle holder at another angle in the first embodiment of this utility model;

[0030] Figure 3 This is a schematic diagram of the microneedle structure in one embodiment of the present invention;

[0031] Figure 4 This is a three-dimensional structural diagram of the needle holder in the second embodiment of the present invention;

[0032] Figure 5 This is a three-dimensional structural diagram of the needle holder in the third embodiment of this utility model;

[0033] Figure 6 This is a three-dimensional structural diagram of the needle holder in the fourth embodiment of the present invention;

[0034] Figure 7 This is a schematic diagram of the microneedle fabrication process in one embodiment of the present invention;

[0035] Figure 8 This is a schematic diagram of the slider in a free state in the fifth embodiment of this utility model;

[0036] Figure 9 This is a schematic diagram of the slider being in a negative pressure state in the fifth embodiment of this utility model;

[0037] Figure 10 This is a schematic perspective view of the cover in an embodiment of the present utility model. Detailed implementation manners

[0038] In order to enable those skilled in the art to better understand the technical solutions in the present utility model, the following will clearly and completely describe the technical solutions in the embodiments of the present utility model with reference to the accompanying drawings in the embodiments of the present utility model. Obviously, the described embodiments are only a part of the embodiments of the present utility model, rather than all the embodiments. Based on the embodiments in the present utility model, all other embodiments obtained by those of ordinary skill in the art without making creative efforts shall fall within the protection scope of the present utility model.

[0039] As Figures 1 to 3 shown, the microneedle in an embodiment of the present utility model includes an integrally formed needle base 11 and a microchip 12 mounted on the needle base 11. When the microchip 12 contacts the skin, it can pierce the skin. The needle base 11 is used to connect to an external drug delivery system and administer drugs to the subcutaneous tissue through the microchip 12.

[0040] The needle base 11 includes a cover body 111, a connecting portion 112, and a support platform 113. The connecting portion 112 is provided with a first injection channel 1121 that can communicate with an external drug delivery device along its axial direction. The cover body 111 encloses an accommodation space with one end open, and the end surface of the cover body 111 away from the opening is connected to the connecting portion 112. The support platform 113 is disposed in the accommodation space of the cover body 111, and the support platform 113 extends from the connecting portion 112 towards the opening direction of the cover body 111. The support platform 113 is provided with a second injection channel 1131 along its axial direction, and the second injection channel 1131 is connected to the first injection channel 1121 for guiding the injection drug from the drug delivery device to the end of the support platform 113 close to the opening of the cover body.

[0041] The connecting portion 112 is preferably a hollow round rod, and a clamping portion 1122 for clamping with the drug delivery device protrudes from the end thereof away from the cover body 111. In other embodiments, the connecting portion 112 can also be detachably connected to the drug delivery device by means of threads or the like.

[0042] In one embodiment, the axial direction of the connecting portion 11 was perpendicular to the end surface of the cover body 111 away from the opening, and the first injection channel 1121 communicated with the second injection channel 1131 through the cover body 111.

[0043] The opening enclosed by the cover body 111 is rectangular. In other embodiments, the cover body 111 can enclose openings of different shapes according to needs by different numbers of end plates. For example, the opening of the cover body 111 can also be triangular, pentagonal, hexagonal, etc. In a preferred embodiment, the opening shape of the cover body 111 can also be circular.

[0044] Refer Figure 1 As shown, in the first embodiment of the present application, the cover 111 is a rectangular body and encloses a receiving space that is generally rectangular. The dimensions (side lengths and cross-sectional areas) of the receiving space from the connecting portion 112 towards the opening direction are the same. Refer Figure 4 As shown, in the second embodiment of the present application, the cover 111 is a conical body and encloses a receiving space that is generally frustum-shaped. The opening of the receiving space is rectangular, and the dimension of the receiving space near the opening is smaller than the dimension near the connecting portion 112.

[0045] The support platform 113 is disposed within the receiving space of the cover 111, and its end near the opening of the cover 111 is used to position and support the microchip 12.

[0046] A plurality of support platforms 113 are arranged in parallel ( Figure 1 4 are shown in the figure), and the outer contour formed by the plurality of support platforms 113 matches the receiving space of the cover 111. For example, for a receiving space with a rectangular cross-section, the plurality of support platforms 113 are arranged in an array in a rectangular shape, and the support platforms 113 are preferably parallel to the inner wall of the cover 111. Additionally, refer Figure 1 As shown, when the receiving space is a rectangular body, the overall outer contour formed by the plurality of support platforms 113 is also generally a rectangular body. Refer Figure 4 As shown, when the receiving space is a conical body, the overall outer contour formed by the plurality of support platforms 113 is also generally a conical body.

[0047] Refer Figure 1 As shown, in the first embodiment of the present application, gaps 1132 are formed at intervals at one end of the plurality of support platforms 113 near the opening of the cover 111, and these gaps 1132 are interconnected, providing a larger flow space during negative pressure operation. Taking Figure 1 the four support platforms 113 in the figure as an example, the gap 1132 is in a cross shape and divides the four support platforms 113.

[0048] When the cross-sectional dimension of the support platform 113 is relatively small and the length is relatively large, the strength of a single support platform 113 is insufficient and it is prone to shaking during operation. Therefore, in a preferred embodiment, the plurality of support platforms 113 are only separated near the opening of the cover 111, and the portions of all the support platforms 113 near the connecting portion 112 are connected into one body to increase the strength of its bottom. Further, each support platform 113 is preferably set as a conical body, and the cross-sectional area of the support platform 113 near the cover 111 is the smallest.

[0049] Refer Figure 5As shown, in the third embodiment of the present application, a plurality of support platforms 113 are joined together in the entire length direction to form an integral body. Four openings of the second injection channels 1131 are distributed in a rectangular array on the support surface 1133, and the support surface 1133 between the four openings is in a cross shape. In this embodiment, the strength of the entire support platform 113 is relatively large and it is not easy to shake, which is suitable for the situation where the size of a single support platform 113 is small and the space between the support platform and the cover 111 is large.

[0050] Refer Figure 6 As shown, in the fourth embodiment of the present application, for small-area drug delivery, only one support platform 113 can also be provided in the cover 111. Preferably, the support platform 113 and the connecting portion 112 are in the same extending direction.

[0051] A negative pressure cavity 114 is formed between the cover 111 and the support platform 113. A negative pressure port communicating with the negative pressure cavity 114 is opened on the cover 111, and a flat negative pressure nozzle 115 is provided on the negative pressure port. The negative pressure nozzle 115 is used to connect to an external negative pressure device.

[0052] The needle seat 11 is integrally formed by 3D printing or injection molding, and the material of the needle seat 11 can also be a conventional 3D printing material or injection molding material. In some embodiments, the needle seat 11 can also be made of a metal material.

[0053] A card slot 1134 is respectively recessed on the end surface of each support platform 113. The bottom of the card slot 1134 is connected to the first injection channel 1121 through the second injection channel 1131. The shape of the card slot 1134 matches the shape of the microchip 12. For example, when the microchip 12 is rectangular, the shape of the card slot 1134 corresponds to a rectangle. The size of the card slot 1134 is the same as the size of the microchip 12, so that the microchip 12 can be exactly held in the card slot 1134.

[0054] A plurality of glue guide holes 113 five are opened on the outer periphery of the edge of the card slot 1134 and are connected to the card slot 1134. The shape of the glue guide holes 113 five is preferably circular. When the card slot :

[0055] Refer Figure 3 As shown, the microchip 12 includes a base portion 121 and a plurality of hollow needles 122 carried on the base portion 121.

[0056] The base portion 121 is cooperatively limited in the card slot 1134, and the shape and size of the base portion 121 match the card slot 1134. For example, when the card slot 1134 is square, the base portion 121 also corresponds to a square and can be exactly held in the card slot 1134.

[0057] The thickness of the base 121 is the same as the depth of the slot 1134. After the base 121 is installed, the surface of the base 121 is flush with the end face of the support platform 113.

[0058] The base 121 can be fixed to the support platform 113 by adhesive, with adhesive formed between the contact surfaces of the base 121 and the support platform 113, and inside the adhesive guide hole 1135.

[0059] The needle 122 is typically 50μm-500μm long and has an outer diameter of 10μm-50μm. Preferred needle 122 lengths are 100μm-400μm, 200μm-350μm, or 250μm-350μm.

[0060] The length, size, and shape of the needle 122 can be individually designed according to the treatment needs. The needle 122 is connected to the first injection channel 1121 through the second injection channel 1131, and can penetrate the stratum corneum of the skin in a directional manner to create a micron-sized mechanical channel, placing the drug directly into the epidermis or upper dermis, so as to participate in the microcirculation and exert a pharmacological response without passing through the stratum corneum.

[0061] Due to the advantages of its tiny structure, the transdermal absorption rate of microchip 12 is stable, and the pain of microchip 12 can often be basically eliminated by controlling its length. Patients can customize microchip 12 according to their condition and purpose and use it at home, which greatly improves the convenience of drug administration.

[0062] The tip of the needle 122 does not protrude beyond the opening of the cover 111; preferably, the tip of the needle 122 is flush with or close to the edge of the opening of the cover 111. The length of the needle 122 should not be too short, such as being retracted inside the cover 111, as this would prevent part of the needle 122 from penetrating the skin, affecting the drug delivery effect. The length of the needle 122 should also not be too long, such as protruding significantly from the opening of the cover 111, as this would result in a greater puncture depth and more pain.

[0063] In a preferred embodiment, the tips of all needles 122 are flush with the plane of the opening of the cover 111. This ensures that when the cover 111 contacts the skin, the tips of the needles 122 make initial contact, preventing discomfort. During negative pressure, the skin, due to its elasticity, bulges inwards from the cover 111 and interacts with the needles 122, achieving slow transdermal penetration. In this embodiment, the height difference between the end of the support platform and the opening of the cover is equal to the length of the needles 122.

[0064] The microchip 12 is preferably made of silicon material through semiconductor processes. In other embodiments, the microchip 12 can also be made of other biocompatible rigid materials. In some embodiments, the microneedles can be made of inorganic materials, preferably titanium, stainless steel, cobalt, ceramics, polyethylene or any material that can be implanted into the skin and / or body. The microneedles can also be made of organic materials, preferably polymers (such as Gantrez polymers), or sugars, polysaccharides, polyethylene, cellulose or hyaluronic acid.

[0065] Combined Figure 7 As shown, when using silicon material, the manufacturing method of the microchip 12 includes:

[0066] S1. Provide a wafer on which grid-shaped cutting channels are defined;

[0067] S2. Form a plurality of through holes arranged in an array on the wafer by etching, and each through hole corresponds to the position of a needle tip 122;

[0068] S3. Further etch along the through holes to form hollow needle tips 122;

[0069] S4. Cut along the cutting channels to form a plurality of Figure 3 As shown in the microchips 12, where each microchip 12 has a plurality of needle tips 122 arranged in an array.

[0070] The microchips in this application are made by semiconductor processes, and microneedles of micro-nano size can be obtained. The process is simple, the size is controllable, and the silicon-based microchips are painless when performing transdermal penetration.

[0071] When the microneedles 10 are working, first, the opening of the cover body 111 faces the area to be administered such as the face, and the cover body 111 is close to the skin. At this time, the needle tips 122 just contact the skin without pain; the negative pressure device is connected to the negative pressure nozzle 115 for negative pressure pumping. At this time, the pressure in the negative pressure chamber 114 decreases, and the cover body 111 is adsorbed on the skin surface; further negative pressure pumping is performed, the skin bulges into the cover body 111, and the needle tips 122 passively pierce the skin; the connecting portion 112 is connected to an external drug delivery device, and the drug sequentially passes through the first injection channel 1121 of the connecting portion 112, the second injection channel 1131 of the support platform 113 and then enters the hollow needle tips 122, thus realizing the drug delivery process to the skin.

[0072] Refer Figure 8As shown, in the fifth embodiment, at least one chute 1111 extending in the opening direction of the cover 111 is provided on the cover 111. A slider 1112 that can approach or move away from the opening of the cover 111 is provided in the chute 1111. A pigment is loaded at one end of the slider 1112 facing the opening of the cover 111. A tension spring 1113 is connected between the end of the slider 1112 facing away from the opening of the cover 111 and the cover 111. The end of the chute 1111 close to the opening of the cover 111 is communicated with the negative pressure chamber 114.

[0073] As shown Figure 8 In the free state, under the pulling force of the tension spring 1113, the slider 1112 is located in the chute 1111, and the end thereof loaded with the pigment is at a certain distance from the opening of the cover 111.

[0074] As shown Figure 9 In the negative pressure state, under the action of the pressure difference, the slider 1112 moves in the opening direction of the cover 111, the tension spring 1113 is pulled and elongated, and the end of the slider 1112 with the pigment can move to the opening of the cover 111 and contact the skin 20, so as to leave a mark on the skin 20.

[0075] In this embodiment, the microneedles 10 will only leave marks on the skin when working under negative pressure. In the free state, the slider will not move to the opening position of the cover, so the problem of mislabeling can be avoided. For example, when the microneedles 10 move on the skin surface to determine the intended drug administration position, no marks will be left. When the position is locked by the negative pressure, generally the area to be administered is determined, and the area is marked after drug administration to avoid the problem of repeated drug administration.

[0076] In order to ensure the sliding effect of the slider 1112 under negative pressure, the sliding contact surface between the slider 1112 and the cover 111 needs to be sealed. In some embodiments, lubricating oil can be provided between the contact surfaces of the slider 1112 and the cover 111, and the material of the slider 1112 can be made of a material with relatively light weight, such as thermoplastic elastomer.

[0077] The pigment in this embodiment refers to all erasable colored materials, preferably ink. The pigment can be adsorbed and stored on a carrier, and the carrier is fixedly connected to the slider.

[0078] In one embodiment, the cover 111 can be provided with spaced double-layer side walls. The space between the two side walls forms the chute 1111. The height of the inner side wall 1114 is less than that of the outer side wall 1115, and a notch 1116 communicating with the negative pressure chamber 114 is formed at one end of the inner side wall 1114 close to the opening of the cover 111.

[0079] The chute 1111 can be annularly wound around the periphery of the cover 111. Correspondingly, the slider 1112 is also arranged along the side of the cover 111. During the negative pressure process, an approximately annular mark can be formed on the skin surface.

[0080] The main purpose of the mark is for area identification. Therefore, in some embodiments, the mark can also be marked by multiple line segments or several points. When marked by points, the marking points preferably correspond to the apex angles of the cover 111. Correspondingly, the chute 1111 and the slider 1112 are arranged at the edge positions of the cover 111.

[0081] In some other embodiments, the cover 111 has a single-layer side wall. Part of the area of the cover 111 can be thickened, and then the chute 1111 is opened at this thickened position. The chute 1111 is preferably located inside the side wall of the cover 111 for convenient connection with the negative pressure chamber 114. The thickened position is preferably arranged along the edge of the cover 111, so as to form a dot-shaped mark.

[0082] Corresponding to the shape of the mark, the slider 1112 can be circular, strip-shaped, etc., and this embodiment does not limit.

[0083] As shown in the figure Figure 10 The microneedle further includes a cover 13. One end of the cover 13 is open for covering the outside of the cover 111 to protect the microchip 12 inside the cover 111.

[0084] In one embodiment, a fan-shaped notch 131 is recessed on one side of the cover 13 for facilitating the opening of the cover 13.

[0085] The embodiment of the present application also provides a transdermal drug delivery device, including a microneedle, a drug delivery device cooperating with the connecting portion for drug delivery, and a negative pressure device connected to the negative pressure port for air extraction. In one embodiment, the transdermal drug delivery device can be a beauty instrument.

[0086] For those skilled in the art, it is obvious that the present invention is not limited to the details of the above exemplary embodiments, and without departing from the spirit or basic characteristics of the present invention, the present invention can be implemented in other specific forms. Therefore, in any aspect, the embodiments should be regarded as exemplary and non-restrictive. The scope of the present invention is defined by the appended claims rather than the above description. Therefore, all changes falling within the meaning and scope of the equivalent elements of the claims are intended to be included in the present invention. Any reference signs in the claims should not be regarded as limiting the claimed rights.

[0087] Furthermore, it should be understood that although this specification describes embodiments, not every embodiment contains only one independent technical solution. This narrative style is merely for clarity. Those skilled in the art should consider the specification as a whole, and the technical solutions in each embodiment can also be appropriately combined to form other embodiments that can be understood by those skilled in the art.

Claims

1. A microneedle, characterized by, The application relates to a micro-needle device, comprising: a needle seat integrally formed, which comprises an open-ended cover, a connecting part connected to the cover and having a first injection channel, and at least one supporting platform arranged in the cover, a negative pressure cavity being formed between the cover and the supporting platform, and a negative pressure port being arranged on the cover and communicating with the negative pressure cavity; a micro-needle sheet comprising a base and a plurality of hollow needle heads carried on the base, the base being fixed to the end of the supporting platform, the needle heads communicating with the first injection channel, and the ends of the needle heads not protruding out of the opening of the cover.

2. The microneedle of claim 1, wherein, At least one sliding groove extending towards the opening of the cover is arranged on the cover, a sliding block capable of approaching or moving away from the opening of the cover is arranged in the sliding groove, the end of the sliding block facing the opening of the cover is loaded with paint, a tension spring is connected between the end of the sliding block away from the opening of the cover and the cover, and the end of the sliding block loaded with paint can move to the opening of the cover under the negative pressure state.

3. The microneedle of claim 2, wherein, The sliding groove is annularly arranged around the cover, or The sliding groove is arranged along the edges of the cover.

4. The microneedle of claim 1, wherein, The end of the supporting platform is concavely provided with a clamping groove communicating with the first injection channel, and the base is matched and limited in the clamping groove.

5. The microneedle of claim 4, wherein, A glue guide hole communicating with the clamping groove is arranged at the top corner of the clamping groove.

6. The microneedle of claim 1, wherein, The end of the supporting platform does not protrude out of the opening of the cover, and the height difference between the end of the supporting platform and the opening of the cover is 50-500 mu m, 100-400 mu m, 200-350 mu m or 250-350 mu m.

7. The microneedle of claim 1, wherein, A plurality of supporting platforms are arranged side by side in the cover, and each supporting platform has a second injection channel communicating between the first injection channel and the needle head.

8. The microneedle of claim 7, wherein, The ends of the plurality of supporting platforms close to the opening of the cover are arranged at intervals.

9. The microneedle of claim 1, wherein, The micro-needle sheet is made of silicon material.

10. A transdermal drug delivery device, characterized in that, The application further relates to a micro-needle device, comprising: the micro-needle as claimed in any one of claims 1 to 9; a medicine supply device matched with the connecting part; and a negative pressure device matched with the negative pressure port.

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