Preparation method of microneedle patch, forming die and alignment and lamination device

Abstract

This invention provides a method for preparing a microneedle patch, a molding die, and an alignment and bonding device. The preparation method includes the following steps: filling a molding die with a molding liquid, the molding die including a frame structure and a molding surface embedded in the frame structure, the frame structure being a rigid material and the molding surface being a flexible material, the molding surface having multiple microneedle cavities for microneedle molding, the molding liquid being introduced into the molding surface and the microneedle cavities, the molding liquid being cured to obtain a substrate and multiple microneedles connected to the substrate, one side of the substrate being exposed on the surface of the molding die; aligning and bonding a substrate film with an adhesive surface to the molding die, so that the substrate film with the adhesive surface is pressed and bonded to the substrate; the substrate film carrying the substrate and the microneedles is removed from the molding die to obtain the microneedle patch. The microneedle patch preparation method provided by this invention can effectively ensure the integrity of microneedle demolding and the accuracy of alignment.

Description

Technical Field

[0001] This invention belongs to the field of microneedle fabrication technology, specifically relating to a method for fabricating microneedle patches, a molding die, and an alignment and bonding device. Background Technology

[0002] Microneedles, a novel transdermal drug delivery technology, consist of multiple micron-sized needles arrayed on a base. The needles are typically 10-2000 micrometers high and 10-50 micrometers wide, capable of penetrating the stratum corneum to create micron-sized mechanical channels. This allows drugs to be placed directly into the epidermis or upper dermis, participating in microcirculation and exerting pharmacological responses without needing to pass through the stratum corneum. Furthermore, they are generally painless and minimally invasive, convenient, safe, and have a wide range of applications. While microneedles have a promising future, challenges remain regarding industrialization, dosage, and manufacturing process quality standards.

[0003] Currently, microneedles are mainly classified into solid microneedles, coated microneedles, soluble microneedles, and hollow microneedles based on their drug delivery methods. Soluble microneedles, made by using biodegradable polymer materials to carry active pharmaceutical ingredients, are soluble microneedles that, after penetrating the stratum corneum, release the functional drug components contained in the needle as the microneedle dissolves. This allows drug molecules to physically pass through the stratum corneum barrier, enabling absorption by the subcutaneous tissue and the body. Unlike other microneedles, this method does not require removal of the needle after insertion; soluble microneedles only require removal of the dressing after administration. It is non-invasive, safe, and highly effective, with good patient compliance, and has therefore become the mainstream in the market.

[0004] The fabrication process of soluble microneedles primarily employs injection molding. Specifically, the drug and adjuvant are injected into a mold, dried, cured, and then demolded to collect the prepared microneedles. Injection molding technology allows control over the microneedle's characteristics, such as morphology, size, and array density, by manipulating the mold. This method is simple and easy to implement, and can be performed in a typical laboratory setting. However, it suffers from significant drawbacks when scaling up production, specifically the following issues:

[0005] 1. When the molding die is made of a rigid material, the tip of the microneedle is prone to breakage due to stress during demolding because rigid materials are difficult to deform. This results in the microneedle not having good penetration performance, and the broken microneedle also affects the preparation of the next batch of microneedle patches. Using silicone as a mold can reduce the stress during demolding. Therefore, existing molding dies are mostly made of materials with low mechanical strength, such as silicone. However, silicone is prone to deformation during use, which affects the precise positioning of subsequent molding liquid injection steps and subsequent bonding steps. At the same time, during the drying process of microneedle molding, its substrate will have a certain shrinkage effect, which will cause the mold to deform, affecting the microneedle molding effect and making demolding difficult.

[0006] 2. Typically, the microneedle preparation process involves manually injecting the molding liquid into the molding mold one by one or in a row, followed by scraping. This method is inefficient and not suitable for the industrial production of microneedle patches.

[0007] 3. The positioning problem of the molding die during mass production: Without manual positioning, the molding die cannot be automatically and accurately positioned, which results in the final molding die and the substrate film not being aligned and bonded, reducing production efficiency and affecting the quality of the final product. Summary of the Invention

[0008] To address the problems of mold deformation and needle breakage during demolding in the existing microneedle patch production process, this invention provides a molding die, an alignment and bonding device, and a method for preparing microneedle patches.

[0009] The technical solution adopted by the present invention to solve the above-mentioned technical problems is as follows:

[0010] On one hand, the present invention provides a method for preparing microneedle patches, comprising the following steps:

[0011] A molding liquid is filled into a molding die. The molding die includes a frame structure and a molding surface embedded in the frame structure. The frame structure is made of a rigid material, and the molding surface is made of a flexible material. Multiple microneedle cavities are provided on the molding surface. The microneedle cavities are used for the molding of microneedles. The molding liquid is introduced into the molding surface and the microneedle cavities. The molding liquid is solidified to form a substrate and multiple microneedles connected to the substrate. One side of the substrate is exposed on the surface of the molding die.

[0012] A substrate film with an adhesive surface is aligned and attached to the molding die, so that the substrate film with an adhesive surface is pressed and bonded to the substrate;

[0013] The substrate film, carrying the substrate and the microneedles, is ejected from the molding die to obtain a microneedle patch.

[0014] Optionally, the rigid material is selected from monocrystalline silicon, stainless steel, aluminum plate, titanium plate, silicate glass, quartz glass, ceramics, polytetrafluoroethylene, polyetheretherketone, or pyridine monoxide propane sulfonate.

[0015] Optionally, there may be multiple molding surfaces, which are spaced apart on the frame structure.

[0016] Optionally, the frame structure is provided with a plurality of molding holes, the molding surface is located on the bottom surface of the molding holes, the molding holes are closed by the molding surface to form molding cavities, and the molding cavities are used for molding the substrate.

[0017] Optionally, the molding die further includes a flexible plate, which is located at the bottom of the frame structure and integrally formed with the molding surface.

[0018] Optionally, the molding die further includes a coating plate, which is detachably disposed on the frame structure, and the coating plate has multiple through holes at positions corresponding to the multiple molding surfaces, the through holes being closed by the molding surfaces to form a molding cavity.

[0019] Optionally, when filling the molding liquid, the molding liquid is introduced onto the molding mold, and the molding liquid is squeezed and filled into multiple molding cavities by a scraper. The molding surface has an air-permeable but liquid-impermeable structure. A vacuum is drawn at the bottom of the molding surface to expel the gas in the microneedle cavity, so that the molding liquid is introduced into the microneedle cavity.

[0020] Optionally, the step of "aligning and attaching the substrate film with an adhesive surface onto the molding die" includes the following operations:

[0021] The molding die is placed in the first area, and the position information of the molding die in the first area is identified by the first positioning unit and transmitted to the control unit.

[0022] The control unit receives the position information of the molding die and simultaneously sends operation information to the alignment unit, which adjusts the molding die to a preset position in the first region.

[0023] A substrate film with a substrate film is placed in the second region. The second positioning unit identifies the position information of the substrate film in the second region and transmits the position information of the substrate film to the control unit.

[0024] The control unit receives the position information of the substrate film and simultaneously sends operation information to the alignment unit, which adjusts the substrate film to a preset position in the second region.

[0025] The alignment unit transfers the forming mold and the substrate film to the bonding area for alignment and overlap;

[0026] The pressing unit presses the molding die and the substrate film together, and the substrate film is bonded to the substrate.

[0027] On the other hand, the present invention provides a molding die, including a frame structure and a molding surface embedded in the frame structure, wherein the frame structure is made of a rigid material and the molding surface is made of a flexible material, and a plurality of microneedle cavities are provided on the molding surface, the microneedle cavities being used for molding microneedles.

[0028] Optionally, there may be multiple molding surfaces, which are spaced apart on the frame structure.

[0029] Optionally, the frame structure is provided with a plurality of molding holes, the molding surface is located on the bottom surface of the molding holes, the molding holes are closed by the molding surface to form molding cavities, and the molding cavities are used for molding the substrate.

[0030] Optionally, the molding die further includes a flexible plate, which is located at the bottom of the frame structure and integrally formed with the molding surface.

[0031] Optionally, the molding die further includes a coating plate, which is detachably disposed on the frame structure, and through holes are provided on the coating plate at positions corresponding to the plurality of molding surfaces, the through holes being closed by the molding surfaces to form molding cavities.

[0032] On the other hand, the present invention provides an alignment and bonding device, comprising:

[0033] The operating area is provided with a first area for placing the molding die and a second area for placing the substrate film.

[0034] A first positioning unit is disposed in the first area. The first positioning unit is used to identify the position information of the molding die in the first area and transmit the position information of the molding die to the control unit.

[0035] A second positioning unit is disposed in the second region. The second positioning unit is used to identify the position information of the substrate film in the second region and transmit the position information of the substrate film to the control unit.

[0036] The control unit is used to receive the position information of the molding die and the position information of the substrate film, and at the same time transmit operation information to the alignment unit;

[0037] The alignment unit is used to receive the operation information from the control unit, move the molding die to a preset position, move the substrate film to a preset position, and align and overlap the molding die and the substrate film.

[0038] The pressing unit is used to press the aligned and overlapping molding die and substrate film together to bond the substrate film to the substrate.

[0039] Optionally, the operating area further includes a bonding area for aligning and bonding the forming mold and the substrate film, wherein the alignment unit can move freely in the first area, the second area and the bonding area.

[0040] Optionally, the first positioning unit and the second positioning unit are selected from a visual alignment device, an ultrasonic positioning device, or an infrared positioning device.

[0041] Optionally, the first region is provided with a first conveying device for supplying molding dies, and the second region is provided with a second conveying device for supplying substrate films.

[0042] Optionally, the alignment unit includes a first robotic arm and a second robotic arm, wherein the first robotic arm is used for moving the forming mold; and the second robotic arm is used for moving the substrate film.

[0043] Optionally, the pressing unit is selected from roller devices and bonding devices.

[0044] According to the microneedle patch preparation method provided by the present invention, a substrate and multiple microneedles connected to the substrate are formed by filling a molding liquid onto a molding mold. The molding mold is prepared by combining flexible and rigid materials. The molding surface is made of flexible material. Compared with rigid material, flexible material has deformable characteristics, which is beneficial to provide an extremely gentle demolding process and can reduce the compressive stress on the microneedle cavity during the demolding process. By fixing the molding surface of the flexible material to the frame structure of the rigid material, the frame structure provides support and fixation for the molding surface, which is used to maintain the stability of the molding surface shape and avoid deformation of the molding surface during the curing and shrinkage of the molding liquid. This effectively improves the molding effect and demolding integrity of the microneedles, and also helps to improve the alignment accuracy of the subsequent substrate film.

[0045] During demolding, an external substrate film adheres to the substrate, and the substrate film carries the substrate and microneedles out of the molding die. This helps to ensure the consistency of the microneedles' ejection direction, thereby avoiding the problem of microneedles breaking due to uneven force. Attached Figure Description

[0046] Figure 1 This is a schematic diagram of the molding die provided by the present invention;

[0047] Figure 2 This is a schematic diagram of another embodiment of the molding die provided by the present invention;

[0048] Figure 3 This is a schematic diagram of another embodiment of the molding die provided by the present invention;

[0049] Figure 4 This is a cross-sectional schematic diagram of the molding die provided by the present invention;

[0050] Figure 5 This is a schematic diagram of the alignment and bonding device provided in an embodiment of the present invention;

[0051] Figure 6 This is a schematic diagram of the alignment and bonding device provided in another embodiment of the present invention;

[0052] Figure 7 This is a schematic diagram of the alignment and bonding device provided in another embodiment of the present invention from another perspective.

[0053] Figure 8 This is a schematic diagram of the structure of the microneedle patch provided by the present invention.

[0054] The reference numerals in the accompanying drawings are as follows:

[0055] 1. Molding mold; 11. Molding cavity; 111. Molding surface; 1111. Microneedle cavity; 112. Molding hole; 113. Through hole; 12. Frame structure; 13. Coating plate; 14. Flexible plate; 2. Alignment and bonding device; 21. Operating area; 211. First area; 212. Second area; 22. Alignment unit; 23. Positioning unit; 24. Flipping and pressing unit; 241. Bonding plate; 242. Flipping mechanism; 25. First moving clamp; 26. Second moving clamp; 27. Moving guide rail; 28. Support; 29. ​​Conveying mechanism; 291. Conveyor belt; 292. Motor; 3. Microneedle; 4. Substrate; 5. Substrate film; 6. Substrate film sheet; 7. Alignment and bonding device; 71. Operating area; 711. First area; 712. Second area; 713. Bonding area; 72. Second positioning unit; 73. First positioning unit; 74. First conveying device; 75. Second conveying device; 76. Alignment unit; 761. First robotic arm; 762. Second robotic arm; 77. Pressing unit. Detailed Implementation

[0056] To make the technical problems solved, the technical solutions, and the beneficial effects of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.

[0057] This invention provides a method for preparing microneedle patches, comprising the following steps:

[0058] A molding liquid is filled into a molding mold 1. The molding mold 1 includes a frame structure 12 and a molding surface 111 embedded in the frame structure 12. The frame structure 12 is made of rigid material, and the molding surface 111 is made of flexible material. A plurality of microneedle cavities 1111 are provided on the molding surface 111. The microneedle cavities 1111 are used for molding microneedles 3. The molding liquid is introduced into the molding surface 111 and the microneedle cavities 1111. The molding liquid is solidified and molded to obtain a substrate 4 and a plurality of microneedles 3 connected to the substrate 4. One side of the substrate 4 is exposed on the surface of the molding mold 1.

[0059] The substrate film 5 with an adhesive surface is aligned and attached to the molding mold 1, so that the substrate film 5 with an adhesive surface is pressed and attached to the substrate 4.

[0060] The substrate film 5, carrying the substrate 4 and the microneedles 3, is ejected from the molding die 1 to obtain a microneedle patch. The structure of the microneedle patch is as follows: Figure 8 As shown.

[0061] The molding liquid is filled into the molding mold 1 to form a substrate 4 and multiple microneedles 3 connected to the substrate 4. The molding mold 1 is made of a combination of flexible and rigid materials. The molding surface 111 is made of flexible material. Compared with rigid material, flexible material has deformable characteristics, which is beneficial to provide an extremely gentle demolding process. It can reduce the extrusion stress of the microneedle cavity 1111 on the microneedle 3 during demolding. By fixing the molding surface 111 of the flexible material to the frame structure 12 of the rigid material, the frame structure 12 has a supporting and fixing function for the molding surface 111, which is used to maintain the stability of the shape of the molding surface 111. It can prevent the molding surface 111 from deforming during the solidification and shrinkage of the molding liquid, thereby effectively improving the molding effect and demolding integrity of the microneedles 3. It also helps to improve the alignment accuracy of the subsequent substrate film 5.

[0062] Meanwhile, during demolding, the external substrate film 5 adheres to the substrate 4, and the substrate film 5 carries the substrate 4 and microneedles 3 out of the molding mold 1. This helps to ensure the consistency of the microneedles 3's ejection direction, thereby avoiding the problem of microneedles 3 breaking due to uneven force.

[0063] In some embodiments, the rigid material includes, but is not limited to, monocrystalline silicon, stainless steel, aluminum plate, titanium plate, silicate glass, quartz glass, ceramics, polytetrafluoroethylene, polyether ether ketone (PEEK), pyridine propane sulfonate, etc., wherein the aluminum plate may be formed by electroplating or anodizing, and the flexible material is selected from siloxanes.

[0064] like Figure 1 and Figure 3 As shown, in one embodiment, there are multiple molding surfaces 111, which are spaced apart on the frame structure 12.

[0065] By setting multiple molding surfaces 111 on the same molding mold 1, multiple microneedle patches can be filled and cured at the same time during the filling of molding liquid, which helps to improve production efficiency.

[0066] In different embodiments, the molding die 1 can be implemented through different structures, specifically:

[0067] like Figure 1As shown, in one embodiment, the frame structure 12 is provided with a plurality of molding holes 112, the molding surface 111 is located on the bottom surface of the molding holes 112, the molding holes 112 are closed by the molding surface 111 to form a molding cavity 11, the molding cavity 11 is used for molding the substrate 4.

[0068] like Figure 2 As shown, in one embodiment, the molding die 1 further includes a flexible plate 14, which is located at the bottom of the frame structure 12 and integrally formed with the molding surface 111.

[0069] like Figure 3 As shown, in another embodiment, the molding die 1 further includes a coating plate 13, which is detachably disposed on the frame structure 12, and the coating plate 13 has a plurality of through holes 113 at positions corresponding to the plurality of molding surfaces 111. The through holes 113 are closed by the molding surfaces 111 to form a molding cavity 11, which is used for molding the substrate 4.

[0070] In this embodiment, the microneedle molding liquid is precisely injected into the corresponding position of the molding mold 1 using the coating plate 13, instead of being injected directly into the position marked on the molding mold 1 as in the prior art. The method provided by this embodiment reduces the impact of deformation of the molding mold during use on the accuracy of the injection position. Furthermore, the batch injection of molding liquid using the coating plate improves the coating efficiency.

[0071] Since air bubbles are easily trapped in the microneedle cavity 1111, it is necessary to reserve excess molding liquid in the initial stage of filling the molding liquid to replenish the molding liquid in the microneedle cavity 1111 after the air bubbles are removed. The molding cavity 11, as a cavity for receiving the molding liquid, has the function of retaining part of the molding liquid. In the subsequent air bubble removal operation, the molding liquid in the molding cavity 11 enters the microneedle cavity 1111 for replenishment. At the same time, the molding cavity 11 also restricts the molding shape of the substrate 4.

[0072] In some embodiments, the horizontal cross-section of the molding cavity 11 is any shape, such as rectangle or ellipse.

[0073] In one embodiment, the depth of the molding cavity 11 is 0.01cm-0.2cm.

[0074] The depth of the molding cavity 11 is related to the thickness of the substrate 4. The depth of the molding cavity 11 can be set according to the required thickness of the substrate 4. Specifically, since a substrate film 5 is used to adhere the substrate 4 in this preparation method, the necessary mechanical strength is mainly provided by the substrate film 5 in subsequent use, and the thickness of the substrate 4 can be reduced accordingly to reduce material costs.

[0075] In some embodiments, the plurality of molding cavities 11 are arranged in a matrix or randomly dispersed.

[0076] In a preferred embodiment, the plurality of molding cavities 11 are arranged in a matrix, with adjacent molding cavities 11 being equidistant from each other, to facilitate the alignment operation during subsequent pressing and bonding of the substrate film 5.

[0077] In some embodiments, the microneedle cavity 1111 is a pointed conical cavity with its tip facing the interior of the molding surface 111, such as a round conical, an elliptical conical, a regular polygonal conical, an irregular polygonal conical, etc.

[0078] In some embodiments, the depth of the microneedle cavity 1111 is 0.001μm-1000μm, and the maximum diameter is 0.005-3000μm. Meanwhile, to ensure a certain density of the microneedle array, the distance between the microneedle cavities 1111 is 4μm-1000μm.

[0079] In different embodiments, when filling the molding liquid, the molding liquid can be introduced into the molding cavity 11 by pressurized spraying, atomized spraying, roller coating, brush coating, injection, screen printing, or scraper extrusion.

[0080] In one embodiment, when filling the molding liquid, the molding liquid is introduced onto the molding mold 1, and a scraper squeezes the molding liquid into the plurality of molding cavities 11. The top surface of the molding mold 1 is flat, and the molding liquid can be introduced into each molding cavity 11 by scraping, while basically ensuring that the liquid level of the molding liquid in each molding cavity 11 is level with the top surface of the molding cavity 11, which helps to ensure the consistency of the amount of molding liquid in each molding cavity 11.

[0081] In different embodiments, the filling molding liquid can be either single-fill or multi-fill.

[0082] For example, in one embodiment, the molding liquid is filled into the molding cavity 11 and the microneedle cavity 1111 by a single injection of molding liquid, resulting in a structure in which the microneedle 3 and the substrate 4 are an integral material.

[0083] In another embodiment, the molding liquid is introduced into the microneedle cavity 1111 and the molding cavity 11 in two separate steps. First, the molding liquid is introduced into the microneedle cavity 1111. At this time, the molding liquid in the molding cavity 11 can be removed by a sponge or other structure. The molding liquid in the microneedle cavity 1111 solidifies to form microneedles 3. Then, the molding liquid is introduced into the molding cavity 11 and solidifies to form the substrate 4. This method can use different molding liquids to form microneedles 3 and substrate 4, and is suitable for the preparation of microneedle patches with different materials for microneedles 3 and substrate 4.

[0084] In other embodiments, microneedles 3 and substrate 4 with more layers can be prepared by introducing the molding liquid three or more times.

[0085] In some embodiments, the molding liquid comprises a solution of a skeleton material capable of being cured and molded, the skeleton material including, but not limited to, acrylonitrile-butadiene-styrene copolymer (ABS), ethylene-vinyl acetate copolymer, polyvinylidene chloride, polyfluorinated olefins, perfluoroolefins, polyacrylonitrile, polyvinyl ketone, dextran, cellulose, heparin, hyaluronic acid, alginate, etc.

[0086] In some embodiments, the molding liquid further includes an active ingredient for pharmaceutical or cosmetic purposes, which may be a trace active substance, DNA, RNA, pharmaceutical preparation, or vaccine.

[0087] In some embodiments, in order to avoid residual air bubbles in the microneedle cavity 1111 affecting the molding of the microneedle 3, the gas in the microneedle cavity 1111 needs to be removed before the molding liquid solidifies.

[0088] The gas in the microneedle cavity 1111 can be removed in several ways: First, after introducing the molding liquid into the molding mold 1, centrifuge the molding mold 1 to generate centrifugal force, thus drawing the molding liquid into the microneedle cavity 1111 and expelling the gas. Second, a vacuum can be applied before introducing the molding liquid into the molding mold 1, removing most of the air before filling the molding mold 1. Third, the air can be heated after introducing the molding liquid into the molding mold 1, causing it to expand, rise, pass through the deposited solution, and leave the molding mold 1, thereby removing the air from the microneedle cavity 1111. Fourth, ultrasonic waves can be applied to expel air bubbles from the microneedle cavity 1111.

[0089] In a preferred embodiment, the molding surface 111 has a breathable but liquid-impermeable structure. A vacuum is drawn at the bottom of the molding surface 111 to expel the gas in the microneedle cavity 1111 and introduce the molding liquid into the microneedle cavity 1111.

[0090] Under vacuum suction conditions, a pressure gradient can be formed between the upper and lower surfaces of the molding surface 111, thereby promoting the gas in the microneedle cavity 1111 to pass through the molding surface 111 and be discharged from the microneedle cavity 1111.

[0091] Specifically, in different embodiments, the molding surface 111 may be an air-permeable but liquid-impermeable structure, while other parts of the molding mold 1 may be an air-impermeable and liquid-impermeable structure, or the molding mold 1 as a whole may be an air-permeable but liquid-impermeable structure.

[0092] In this embodiment, after the molding liquid is introduced into the molding mold 1, the molding mold 1 is placed in a vacuum suction device. Then, the bottom of the molding mold 1 is suctioned under a negative pressure environment of 8000-10000 Pa, so that the molding liquid completely fills the microneedle cavity 1111 in the molding mold 1. The bottom of the molding mold 1 may be provided with a hole that connects to the vacuum suction device. The hole diameter is set to 20-1000 nm, so that the vacuum suction device can suck the molding liquid downward through the hole, but will not allow the molding liquid to flow into the vacuum suction device from the hole. In order to quickly dry and solidify the molding liquid, while avoiding excessive drying that affects the fluidity of the molding liquid (poor fluidity will prevent complete filling of the microneedle cavity 1111), the humidity in the vacuum suction device can be set between 25% and 40%. Preferably, the humidity in this embodiment is set to 32%-35%.

[0093] In some embodiments, the curing method of the molding liquid may be one or more combinations of heating curing, thermal convection drying, thermal conduction drying and / or thermal radiation drying, room temperature convection drying, room temperature static drying, low temperature convection drying, low temperature static drying, reduced pressure drying, normal pressure drying, microwave drying, chemical crosslinking, and UV curing.

[0094] In one embodiment, the curing method of the molding liquid is to air dry it at a temperature of 20-25°C for 3-4 hours to avoid the decomposition of the active ingredients in the molding liquid. At the same time, the air speed is controlled within the range of 6-9 m / s, so that the molding liquid is not blown out of the molding mold 1, and the curing rate is not reduced due to too low an air speed, which would affect the production efficiency.

[0095] In the bonding step of this preparation method, the substrate film 5 needs to be bonded to the substrate 4 formed on the molding mold 1. There is a problem of bonding position deviation. In order to solve this problem, the present invention has made further improvements to the bonding method, which will be described below through specific embodiments.

[0096] In some embodiments, the step of "aligning and attaching the substrate film 5 with an adhesive surface onto the molding die 1" includes the following operations:

[0097] The molding die 1 is placed in the first region 711, and the first positioning unit 73 identifies the position information of the molding die 1 in the first region 711 and transmits the position information of the molding die 1 to the control unit.

[0098] The control unit receives the position information of the molding die 1 and simultaneously sends operation information to the alignment unit 76, which adjusts the molding die 1 to the preset position of the first region 711.

[0099] A substrate film 6 with a substrate film 5 is placed in the second region 712. The second positioning unit 72 identifies the position information of the substrate film 6 in the second region 712 and transmits the position information of the substrate film 6 to the control unit.

[0100] The control unit receives the position information of the substrate film 6 and simultaneously sends operation information to the alignment unit 76, which adjusts the substrate film to the preset position of the second region 712.

[0101] The alignment unit 76 transfers the forming mold 1 and the substrate film 6 to the bonding area 713 for alignment and overlap;

[0102] The pressing unit 77 presses the molding die 1 and the substrate film 6 together, and the substrate film 5 is bonded to the substrate 4.

[0103] By identifying the position information of the molding die 1 in the first region 711 and the position information of the substrate film 6 in the second region 712, the position of the molding die 1 in the first region 711 and the position of the substrate film 6 in the second region 712 are adjusted so that the molding die 1 and the substrate film 6 have a corresponding positional relationship. Then, the alignment unit 76 can accurately press the molding die 1 onto the substrate film 6, avoiding the problem of misalignment caused by the positional deviation of the molding die 1.

[0104] like Figure 5 As shown, one embodiment of the present invention provides an alignment and bonding device 7, comprising:

[0105] The operating area 71 is provided with a first area 711 for placing the molding die 1 and a second area 712 for placing the substrate film 6.

[0106] A first positioning unit 73 is disposed in the first region 711. The first positioning unit 73 is used to identify the position information of the molding die 1 in the first region 711 and transmit the position information of the molding die 1 to the control unit.

[0107] The second positioning unit 72 is disposed in the second region 712. The second positioning unit 712 is used to identify the position information of the substrate film 6 in the second region 712 and transmit the position information of the substrate film 6 to the control unit.

[0108] The control unit is used to receive the position information of the molding die 1 and the position information of the substrate film 6, and at the same time transmit operation information to the alignment unit 76.

[0109] The alignment unit 76 is used to receive the operation information from the control unit, move the molding die 1 to a preset position, move the substrate film 6 to a preset position, and align and overlap the molding die 1 and the substrate film 6.

[0110] The pressing unit 77 is used to press the aligned and overlapping molding die 1 and substrate film 6 together to bond the substrate film to the substrate.

[0111] In this embodiment, the operation area 71 further includes a bonding area 713 for aligning and bonding the molding die 1 and the substrate film 6, and the alignment unit 76 can move freely in the first area 711, the second area 712 and the bonding area 713.

[0112] In this embodiment, the control unit has calculation and storage functions, and can issue operation information based on the graphic data provided by the first positioning unit 73 and the second positioning unit 72 to control the action of the alignment unit 76.

[0113] In this embodiment, the first positioning unit 73 and the second positioning unit 72 are selected from a visual alignment device, an ultrasonic positioning device, or an infrared positioning device.

[0114] In this embodiment, the first region 711 is provided with a first conveying device 74 for supplying the molding die 1, and the second region 712 is provided with a second conveying device 75 for supplying the substrate film 6.

[0115] In this embodiment, the alignment unit 76 includes a first robotic arm 761 and a second robotic arm 762. The first robotic arm 761 is used for moving the molding die 1, and the second robotic arm 762 is used for moving the substrate film 6.

[0116] In this embodiment, the pressing unit 77 is selected from a roller device or a pressing device. The pressing surface of the pressing device is a flexible panel, which presses the molding mold 1 and the substrate film 6 from top to bottom.

[0117] like Figure 6 and Figure 7 As shown, another embodiment of the present invention provides an alignment and bonding device 2, comprising:

[0118] The operation area 21 is provided with a first area 211 for placing the molding die 1 and a second area 212 for placing the substrate film 6;

[0119] A positioning unit 23 is disposed in the first region 211. The positioning unit 23 is used to identify the position information of the molding die 1 in the first region 211 and transmit the position information of the molding die 1 to the control unit.

[0120] The control unit is used to receive the position information of the molding die 1 and simultaneously transmit operation information to the alignment unit 22;

[0121] Alignment unit 22 is disposed in the second region 212. Alignment unit 22 is used to receive operation information from the control unit and move the position of the substrate film 6 in the second region 212 so that the position of the substrate film 6 corresponds to that of the molding die 1.

[0122] The flip-pressing unit 24 is used to flip and press the molding die 1 located in the first region 211 onto the substrate film 6 in the second region 212, so that the substrate film 5 is bonded to the substrate 4.

[0123] In this embodiment, the alignment and bonding device 2 further includes a bracket 28, a moving guide rail 27, a first moving clamp 25, and a second moving clamp 26. The bracket 28 is disposed on the operating area 21, and the moving guide rail 27 is located on the bracket 28 and is located at the top of the first area 211 and the second area 212. The alignment unit 22 is connected to the first moving clamp 25, and the positioning unit 23 is connected to the second moving clamp 26. The first moving clamp 25 and the second moving clamp 26 are displaceably disposed on the moving guide rail 27. The positions of the alignment unit 22 and the positioning unit 23 can be adjusted by the first moving clamp 25 and the second moving clamp 26, thereby improving the adaptability to the positions of the molding die 1 and the substrate film 6.

[0124] In some embodiments, the alignment unit may be a single device or a combination of multiple devices.

[0125] In this embodiment, the alignment unit 22 is selected from a robotic arm, and the alignment unit 22 can move arbitrarily in the XYZ axis coordinate system of the first region 211.

[0126] In some embodiments, the positioning unit 23 may be a visual alignment device, an ultrasonic positioning device, or an infrared positioning device.

[0127] In this embodiment, the positioning unit 23 is selected from a visual alignment device.

[0128] In this embodiment, the control unit has calculation and storage functions, and can issue operation information based on the graphic data provided by the positioning unit 23 to control the action of the alignment unit 22.

[0129] In this embodiment, the flipping and pressing unit 24 includes a bonding plate 241 and a flipping mechanism 242. The bonding plate 241 is located in the first region 211, and the flipping mechanism 242 is connected to the bonding plate 241. The bonding plate 241 is provided with a plurality of vacuum nozzles for adsorbing and fixing the molding die 1.

[0130] In this embodiment, a spring is provided between the bonding plate 241 and the flipping mechanism 242 to connect them. The spring can prevent excessive pressing between the molding mold 1 and the substrate film 6 during the pressing process, thus avoiding damage to the microneedles 3 caused by excessive pressing force.

[0131] In this embodiment, the flipping mechanism 242 is selected from a robotic arm.

[0132] In this embodiment, the second region 212 is provided with a conveying mechanism 29 for supplying the substrate film 6.

[0133] Specifically, the conveying mechanism 29 includes a conveyor belt 291 and a motor 292. The conveyor belt 291 is used to transport the substrate film 6, and the motor 292 is used to drive the operation of the conveyor belt.

[0134] In this embodiment, after the molded mold 1 is cured and transported to the upper surface of the bonding plate 241, its position is fixed by the vacuum nozzle on the bonding plate 241. Then, the visual alignment device starts to take pictures of the molded mold 1 and transmits the position information of the molded mold 1 to the control unit (not shown in the figure) for storage and reading. The control unit performs calculations based on the position information and transmits operation instructions to the alignment unit, so that the alignment unit adjusts the position of the substrate film 6 on the conveyor belt 291 until the substrate film 6 and the molded mold 1 are in a relatively confirmed position. In this embodiment, in order to achieve fast and accurate bonding, the position of the substrate film 6 and the molded mold 1 is adjusted to be mirror symmetrical with respect to the center line of the operation area 21. Then, the forming mold 1 on the bonding plate 241 is flipped to the substrate film 6 by the bonding and flipping mechanism 242 for pressing, so that multiple substrates 4 are attached to multiple substrate films 5 one by one. The substrate film 5 and the forming mold 1 are separated, and the micro needles 3 and the substrates 4 are peeled from the micro needle cavity 1111 and the forming cavity 11 in the forming mold 1 and combined with the substrate film 5, thus completing the production of micro needle patch.

[0135] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A method for preparing a microneedle patch, characterized in that, The following steps are included: A molding liquid is filled into a molding die. The molding die includes a frame structure and a molding surface embedded in the frame structure. The frame structure is made of a rigid material, and the molding surface is made of a flexible material. Multiple microneedle cavities are provided on the molding surface. The microneedle cavities are used for the molding of microneedles. The molding liquid is introduced into the molding surface and the microneedle cavities. The molding liquid is solidified to form a substrate and multiple microneedles connected to the substrate. One side of the substrate is exposed on the surface of the molding die. A substrate film with an adhesive surface is aligned and attached to the molding die, so that the substrate film with an adhesive surface is pressed and bonded to the substrate; Includes the following operations: The molding die is placed in the first area, and the position information of the molding die in the first area is identified by the first positioning unit and transmitted to the control unit. The control unit receives the position information of the molding die and simultaneously sends operation information to the alignment unit, which adjusts the molding die to a preset position in the first region. A substrate film with a substrate film is placed in the second region. The second positioning unit identifies the position information of the substrate film in the second region and transmits the position information of the substrate film to the control unit. The control unit receives the position information of the substrate film and simultaneously sends operation information to the alignment unit, which adjusts the substrate film to a preset position in the second region. The alignment unit transfers the forming mold and the substrate film to the bonding area for alignment and overlap; The pressing unit presses the molding die and the substrate film together, and the substrate film is bonded to the substrate; The substrate film, carrying the substrate and the microneedles, is ejected from the molding die to obtain a microneedle patch.

2. The method for preparing the microneedle patch according to claim 1, characterized in that, The rigid materials include monocrystalline silicon, stainless steel, aluminum plate, titanium plate, silicate glass, quartz glass, ceramics, polytetrafluoroethylene, polyetheretherketone, or pyridine monoxide propane sulfonate.

3. The method for preparing the microneedle patch according to claim 1, characterized in that, The number of the molding surfaces is multiple, and the multiple molding surfaces are spaced apart on the frame structure.

4. The method for preparing the microneedle patch according to claim 3, characterized in that, The frame structure is provided with multiple molding holes, the molding surface is located on the bottom surface of the molding hole, the molding hole is closed by the molding surface to form a molding cavity, and the molding cavity is used for molding the substrate.

5. The method for preparing the microneedle patch according to claim 4, characterized in that, The molding die also includes a flexible plate, which is located at the bottom of the frame structure and integrally formed with the molding surface.

6. The method for preparing the microneedle patch according to claim 3, characterized in that, The molding die also includes a coating plate, which is detachably disposed on the frame structure, and through holes are provided on the coating plate at positions corresponding to the plurality of molding surfaces, the through holes being closed by the molding surfaces to form molding cavities.

7. The method for preparing the microneedle patch according to any one of claims 4 to 6, characterized in that, When filling the molding liquid, the molding liquid is introduced onto the molding mold, and the molding liquid is squeezed and filled into multiple molding cavities by a scraper. The molding surface has an air-permeable but liquid-impermeable structure. A vacuum is drawn at the bottom of the molding surface to expel the gas in the microneedle cavity, so that the molding liquid is introduced into the microneedle cavity.

8. A fitting and bonding device, characterized in that, include: The operating area is provided with a first area for placing the molding die and a second area for placing the substrate film. A first positioning unit is disposed in the first area. The first positioning unit is used to identify the position information of the molding die in the first area and transmit the position information of the molding die to the control unit. A second positioning unit is disposed in the second region. The second positioning unit is used to identify the position information of the substrate film in the second region and transmit the position information of the substrate film to the control unit. The control unit is used to receive the position information of the molding die and the position information of the substrate film, and at the same time transmit operation information to the alignment unit; The alignment unit is used to receive the operation information from the control unit, move the molding die to a preset position, move the substrate film to a preset position, and align and overlap the molding die and the substrate film. The pressing unit is used to press the aligned and overlapping molding die and substrate film together to bond the substrate film to the substrate.

9. The alignment and bonding device according to claim 8, characterized in that, The operating area also includes a bonding area for aligning and bonding the forming mold and the substrate film, and the alignment unit can move freely in the first area, the second area and the bonding area.

10. The alignment and bonding device according to claim 8, characterized in that, The first positioning unit and the second positioning unit are selected from a visual alignment device, an ultrasonic positioning device, or an infrared positioning device.

11. The alignment and bonding device according to claim 8, characterized in that, The first area is provided with a first conveying device for supplying molding dies, and the second area is provided with a second conveying device for supplying substrate films.

12. The alignment and bonding device according to claim 8, characterized in that, The alignment unit includes a first robotic arm and a second robotic arm. The first robotic arm is used for moving and adjusting the molding die, and the second robotic arm is used for moving and adjusting the substrate film.

13. The alignment and bonding device according to claim 8, characterized in that, The pressing unit is selected from roller device and pressing device.

Images