Apparatus and method for making microneedles

Abstract

The present application relates to a kind of equipment and method for preparing microneedle, the equipment for preparing microneedle includes microneedle mould, vacuum chamber, filling mechanism, scraper mechanism and screen plate;The surface of microneedle mould is provided with recess matched with microneedle needle body;Screen plate is used to be set on the microneedle mould and cover recess;Filling mechanism is at least partially arranged in vacuum chamber, and is used to release the solution for preparing microneedle, and the released solution is used to flow into microneedle mould via screen plate;Scraper mechanism includes scraper, and scraper is used to contact with screen plate and move relative to screen plate to scrape the solution on the surface of screen plate.The advantage of the present application is that the excess solution on the surface of microneedle mould can be scraped clean, and the process of scraping the excess solution on the surface can also ensure that the recess is filled with solution, ensuring the product quality of microneedle, without repeated scraping operation, improving the efficiency of microneedle preparation.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of micro-needle preparation, and particularly relates to a device and method for preparing micro-needles. BACKGROUND

[0002] Most therapeutic drugs enter the human body by using subcutaneous injection, which is a low-cost, fast and direct drug delivery method. However, patients themselves cannot easily use the syringe, and the pain and fear brought by the syringe further limit the patient's compliance. The micro-needle (including a needle head with a size of microns) loads drugs and delivers drugs transdermally, which is one of the methods to solve the above problems. The transdermal drug delivery method of the micro-needle can achieve painless drug delivery, improve patient compliance and safety. At the same time, the micro-needle can also realize quantitative and positioning delivery of drugs, and can achieve precise drug delivery with good drug delivery effect. In addition, the micro-needle can also be used for skin pretreatment and has the ability to enhance skin permeability. Therefore, the micro-needle has good clinical application prospect.

[0003] At present, the main process for manufacturing micro-needles is vacuum casting. The vacuum casting method is to cast a drug-loaded polymer solution into a micro-needle mold, promote the polymer solution to enter the groove of the micro-needle mold by vacuum or the like, exclude air bubbles, and then dry to obtain the required micro-needle. The key to preparing the micro-needle by the vacuum casting method is to fill the polymer solution into the micro-needle mold with a groove. Because the polymer solution used is relatively viscous, it is not easy to enter the groove of the micro-needle mold, especially the groove size of the micro-needle mold is small (some parts are even only a few microns), and air bubbles are inevitably generated in the groove and are not easy to be removed during the casting process. The existence of air bubbles will affect the quality of the micro-needle to some extent. Moreover, in order to prepare a split type micro-needle (i.e. the needle body and the base are separated), after the polymer solution is cast, the excess solution coated on the surface of the micro-needle mold needs to be scraped off by a scraper. However, if the force of the scraper contacting the micro-needle mold is too large, the solution in the groove will also be scraped off, and if the force of the scraper contacting the micro-needle mold is too small, the contact will not be good and the solution cannot be scraped clean. Therefore, in actual operation, it is difficult to control the force of the scraper contacting the micro-needle mold, and the product quality of the polymer micro-needle cannot be guaranteed. Moreover, in order to scrape clean, the solution on the surface of the micro-needle mold often needs to be scraped off repeatedly, which is low in efficiency. SUMMARY

[0004] In order to solve the technical problems existing in the prior art, the purpose of the present application is to provide a device and method for preparing micro-needles, which can scrape off the excess solution on the surface of the micro-needle mold clean, and also ensure that the solution fills the groove during the process of scraping off the excess solution on the surface, so as to ensure the product quality of the micro-needle, and at the same time, the scraping off operation does not need to be repeated many times, so as to improve the efficiency.

[0005] To achieve the above object, the application provides a device for preparing microneedles, comprising a microneedle mold, a vacuum chamber, a filling mechanism, a scraper mechanism and a mesh plate.

[0006] The surface of the microneedle mold is provided with grooves matched with the microneedle bodies.

[0007] The mesh plate is arranged on the microneedle mold and covers the grooves.

[0008] The filling mechanism is at least partially arranged in the vacuum chamber and is used to release a solution for preparing microneedles, and the released solution is used to flow into the microneedle mold through the mesh plate.

[0009] The scraper mechanism comprises a scraper which is used to contact and move relative to the mesh plate to scrape off the solution on the surface of the mesh plate.

[0010] Optionally, the scraper is arranged in line contact or surface contact with the mesh plate.

[0011] Optionally, the size of the mesh hole on the mesh plate is greater than or equal to the size of the groove on the microneedle mold.

[0012] Optionally, the side cross-sectional shape of the mesh hole is the same as the side cross-sectional shape of the groove.

[0013] Optionally, the thickness of the mesh plate is 0.05mm-0.2mm.

[0014] Optionally, the device further comprises a vacuum pumping mechanism and / or a mesh plate loading mechanism, the vacuum pumping mechanism is used to pump the vacuum chamber, the mesh plate loading mechanism is used to drive the mesh plate to move and place the mesh plate on the microneedle mold, and the mesh plate loading mechanism is also used to remove the mesh plate from the microneedle mold.

[0015] Optionally, the mesh plate loading mechanism comprises a mesh plate loading frame and a mesh plate fixing block, the mesh plate loading frame and the mesh plate fixing block jointly clamp and fix the edge of the mesh plate, and the mesh plate loading frame is a hollow structure.

[0016] Optionally, the device further comprises a tensioning mechanism arranged on the mesh plate loading mechanism and used to tension the mesh plate so that the mesh plate covers the microneedle mold in a flat state.

[0017] Optionally, the tensioning mechanism comprises a tensioning piece and an adjusting screw, the tensioning piece is used to be detachably fixedly connected with the mesh plate fixing block, the tensioning piece is also used to be connected with the mesh plate loading frame through the adjusting screw, and the adjusting screw is used to adjust the relative position between the tensioning piece and the mesh plate loading frame.

[0018] Optionally, the net plate loading mechanism comprises a pressure sensor for detecting the pressure between the net plate and the microneedle mold and generating pressure information.

[0019] Optionally, the device further comprises a control device in communication with the pressure sensor, the control device being configured to control the net plate loading mechanism to adjust the fitting state between the net plate and the microneedle mold according to the pressure information detected by the pressure sensor.

[0020] Optionally, the device further comprises a liquid return pipeline, one end of the liquid return pipeline extending into the vacuum chamber and being connected to a solution recovery tank, the solution recovery tank being configured to receive the solution scraped off from the net plate.

[0021] Optionally, the device further comprises a net plate loading mechanism, the net plate loading mechanism being configured to drive the net plate to move and place the net plate on the microneedle mold, and remove the net plate from the microneedle mold.

[0022] The solution recovery tank is arranged on the net plate loading mechanism and is configured to be arranged on one side of the net plate.

[0023] Optionally, the device further comprises a coarse positioning mechanism and a rotary motion table, the rotary motion table being arranged in the vacuum chamber, the coarse positioning mechanism being arranged on the rotary motion table, the coarse positioning mechanism being configured to place the microneedle mold and perform coarse positioning, and the rotary motion table being configured to rotate to realize fine positioning of the microneedle mold.

[0024] Optionally, the device comprises an X-direction motion mechanism, a Y-direction first motion mechanism and a Z-direction first motion mechanism, the Z-direction first motion mechanism being arranged on the X-direction motion mechanism, the X-direction motion mechanism and the Y-direction first motion mechanism being independently arranged, the rotary motion table being arranged on the Y-direction first motion mechanism, the Y-direction first motion mechanism being configured to drive the rotary motion table to move horizontally along the Y-direction, the X-direction motion mechanism being configured to drive the net plate and / or the scraper to move horizontally along the X-direction, and the Z-direction first motion mechanism being configured to drive the net plate and / or the scraper to move vertically along the Z-direction, the X-direction, the Y-direction and the Z-direction being perpendicular to each other.

[0025] Optionally, the device further comprises a Y-direction second motion mechanism and a Z-direction second motion mechanism, the Y-direction second motion mechanism being arranged on the Z-direction first motion mechanism, and the Z-direction second motion mechanism being arranged on the Y-direction second motion mechanism, the Y-direction second motion mechanism being configured to drive the scraper to move horizontally along the Y-direction, and the Z-direction second motion mechanism being configured to drive the scraper to move vertically along the Z-direction.

[0026] Optionally, the device further comprises a vision recognition device and a control device connected in communication, the vision recognition device is configured to recognize the position of the microneedle mold, and the control device is configured to position the position of the screen plate relative to the microneedle mold according to the position of the microneedle mold.

[0027] Optionally, the vision recognition device comprises a camera and at least two alignment markers, the camera is arranged in the vacuum chamber, and the at least two alignment markers are arranged on the microneedle mold; the camera is configured to acquire image information of the at least two alignment markers, and the vision recognition device is configured to recognize the position of the microneedle mold according to the image information of the at least two alignment markers.

[0028] Optionally, the at least two alignment markers are arranged on the diagonal lines of the microneedle mold.

[0029] Optionally, the scraper mechanism further comprises a first base and a second base, the scraper is detachably fixedly connected with the first base, and the first base is movably connected with the second base.

[0030] Optionally, the first base and the second base are movably connected through a ball head pin.

[0031] Optionally, the scraper mechanism further comprises an elastic structure, which is configured to provide an elastic force to the scraper, so that the scraper can adaptively adjust the position relative to the screen plate.

[0032] Optionally, the elastic structure comprises a plurality of springs, one end of the plurality of springs is telescopically arranged on the first base, and the other end is telescopically arranged on the second base.

[0033] Optionally, a fixing rod is arranged in the spring, at least one end of the fixing rod is fixedly connected with the first base or the second base, and the spring is configured to be telescopically arranged on the fixing rod.

[0034] Optionally, the scraper mechanism further comprises a dust cover arranged between the first base and the second base and configured to seal the hollowed-out area between the first base and the second base.

[0035] Optionally, a limiting pin is arranged on the second base, the ball head pin is arranged on the first base, a pin hole matched with the limiting pin is arranged on the ball head pin, and the axis of the limiting pin is arranged to be inclined relative to the vertical direction.

[0036] Optionally, the entire surface of the screen plate is provided with a hydrophobic layer, and the hole wall of the screen hole of the screen plate is provided with a hydrophobic layer.

[0037] To achieve the above-mentioned purpose, the application further provides a method for preparing a microneedle, comprising:

[0038] The micro-needle mold is provided with grooves matching the micro-needle body on the surface thereof;

[0039] The micro-needle mold is placed in a vacuum chamber, and a screen plate is placed on the micro-needle mold so as to cover the grooves on the micro-needle mold;

[0040] The vacuum chamber is evacuated, and a solution for preparing micro-needles is cast to the micro-needle mold covered with the screen plate through a filling mechanism, and the released solution flows into the micro-needle mold through the screen plate;

[0041] A scraper is brought into contact with the screen plate, and the scraper is horizontally moved relative to the screen plate to scrape off the solution on the surface of the screen plate;

[0042] The screen plate and the scraper are removed to obtain the micro-needle mold with the cast solution;

[0043] The micro-needle mold with the cast solution is dried in a broken vacuum state, and is demolded to obtain the micro-needle body after drying.

[0044] Optionally, when the scraper is arranged, the scraper is brought into line contact or surface contact with the screen plate.

[0045] Optionally, when the screen plate is arranged, a tensioning mechanism is used to tension the screen plate so as to cover the screen plate on the micro-needle mold in a flat state.

[0046] Optionally, when the screen plate is arranged, a pressure sensor is used to detect the pressure between the screen plate and the micro-needle mold, and the fitting state between the screen plate and the micro-needle mold is adjusted according to the pressure.

[0047] Optionally, before the screen plate is placed on the micro-needle mold, the method further comprises:

[0048] A visual recognition device is used to recognize the position of the micro-needle mold, and the position of the screen plate relative to the micro-needle mold is positioned according to the position of the micro-needle mold.

[0049] Optionally, when the solution on the surface of the screen plate is scraped off, the scraper can be self-adaptively adjusted relative to the position of the screen plate.

[0050] In the above-mentioned device and method for preparing micro-needles, the solution on the surface of the micro-needle mold can be completely scraped off by covering the screen plate on the micro-needle mold, and the solution can fill the grooves during the process of scraping off the solution on the surface, so as to ensure the product quality of the micro-needles, and the scraping operation is not required to be repeatedly performed for multiple times, and the preparation efficiency of the micro-needles is improved.

[0051] In the above device and method for preparing microneedles, the "string drawing" problem during removal of the screen plate can be effectively reduced by arranging a hydrophobic layer on the surface of the screen plate, further ensuring the product quality of the microneedles.

[0052] In the above device and method for preparing microneedles, the screen plate is tensioned by the tensioning mechanism to cover the microneedle mold in a flat state, ensuring that the screen plate can be completely attached to the microneedle mold, thereby ensuring the forming quality of the microneedles.

[0053] In the above device and method for preparing microneedles, the position of the microneedle mold can be recognized by the visual recognition device, so that the screen plate can be accurately placed on the microneedle mold according to the position of the microneedle mold, thereby reducing the positioning difficulty and ensuring the positioning accuracy of the screen plate.

[0054] In the above device and method for preparing microneedles, the position of the screen plate is adjusted by the scraper, so that the scraper can effectively scrape the solution on the screen plate. Even if the scraper is not parallel to the screen plate, the scraper can still ensure sufficient contact with the screen plate to avoid the problem of incomplete scraping of the solution due to lack of contact. BRIEF DESCRIPTION OF DRAWINGS

[0055] Those skilled in the art will understand that the provided drawings are for better understanding of the present application, and do not constitute any limitation on the scope of the present application. Among them:

[0056] Figure 1 A flowchart for preparing microneedles is provided for the preferred embodiment of the present application;

[0057] Figure 2 A structural schematic diagram of the device for preparing microneedles is provided for the preferred embodiment of the present application;

[0058] Figure 3 A structural schematic diagram of the device for preparing microneedles after removal of the vacuum chamber is provided for the preferred embodiment of the present application;

[0059] Figure 4 A structural schematic diagram of the scraper and the screen plate in surface contact is provided for the preferred embodiment of the present application;

[0060] Figure 5 A structural schematic diagram of the screen plate loading mechanism is provided for the preferred embodiment of the present application;

[0061] Figure 6 A structural schematic diagram of the scraper mechanism is provided for the preferred embodiment of the present application, wherein part of the structure is shown in a partial cross-section;

[0062] Figure 7 A structural schematic diagram of the scraper mechanism is provided for another preferred embodiment of the present application, wherein part of the structure is shown in a partial cross-section;

[0063] Figure 8Structure diagram of the microneedle mold for the solution to be cast provided for the preferred embodiment of the present application;

[0064] Figure 9 Principle diagram of setting the screen plate on the microneedle mold provided for the preferred embodiment of the present application;

[0065] Figure 10 Principle diagram of casting the solution on the microneedle mold provided for the preferred embodiment of the present application, on which the screen plate is set;

[0066] Figure 11 Principle diagram of scraping the excess solution on the screen plate by the scraper provided for the preferred embodiment of the present application;

[0067] Figure 12 Schematic diagram of removing the screen plate provided for the preferred embodiment of the present application;

[0068] Figure 13 Structure diagram of the microneedle mold for the solution to be cast provided for the preferred embodiment of the present application, on which the screen plate is removed, and the grooves of the microneedle mold are filled with the solution.

[0069] BRIEF DESCRIPTION OF THE DRAWINGS

[0070] 11-microneedle mold; 111-groove; 12-vacuum chamber; 13-filling mechanism; 131-filling needle; 132-filling pipeline; 133-liquid return pipeline; 134-solution recovery tank; 14-vacuum pumping mechanism; 141-vacuum pump; 142-vacuum pumping pipeline; 143-sensor; 144-vacuum breaking pipeline; 15-screen plate loading mechanism; 151-screen plate loading rack; 1511-fixing arm; 152-screen plate fixing block; 153-locking screw; 154-tensioning element; 155-adjusting screw; 156-pressure sensor; 16-scraper mechanism; 161-scraper; 162-connector; 163-first base; 1631-ball head pin; 1632-first spring mounting hole; 164-second base; 1641-groove hole; 1642-second spring mounting hole; 1643-limiting pin; 165-spring; 166-fixing rod; 167-dust cover; 168-fixing screw; 17-screen plate; 18-rough positioning mechanism; 19-rotary motion table; 20-vision recognition device; 21-control device; 22-camera; 23-alignment mark; 24-first motion mechanism in X direction; 25-first motion mechanism in Y direction; 26-first motion mechanism in Z direction. DETAILED DESCRIPTION

[0071] The application will now be described in more detail, by way of example, with reference to the accompanying drawings, in which:

[0072] For clarity, not all of the features of an actual implementation can be described in this detailed description. In the following description, numerous specific details are set forth to provide an understanding of the application. However, it will be apparent to one of ordinary skill in the art that the application can be practiced without the specific details. In other instances, well-known features are not described in detail to avoid obscuring aspects of the application. It should be understood that the description is not limited to the particular details of the examples described herein.

[0073] The application is described more particularly below in the following paragraphs with reference to the accompanying drawings. The advantages and features of the application will become more fully understood from the following description, taken in conjunction with the accompanying drawings. It should be understood that the drawings are not to scale, and are merely intended to facilitate an understanding of the application. In the drawings:

[0074] The application is described more particularly below in the following paragraphs with reference to the accompanying drawings. The advantages and features of the application will become more fully understood from the following description, taken in conjunction with the accompanying drawings. It should be understood that the drawings are not to scale, and are merely intended to facilitate an understanding of the application. In the drawings:

[0075] Figure 2 and Figure 3 A schematic diagram of the apparatus for preparing microneedles is shown. As shown in Figure 2 and Figure 3 The application also provides an apparatus for preparing microneedles, which comprises a microneedle mold 11, a vacuum chamber 12, a filling mechanism 13, a scraper mechanism 16 and a screen plate 17, and preferably further comprises a vacuum extraction mechanism 14 and a screen plate loading mechanism 15. The surface of the microneedle mold 11 is provided with grooves 111 matching the microneedle bodies (see Figure 8 ).

[0076] The vacuumizing mechanism 14 is used to vacuumize the vacuum chamber 12. In some embodiments, the vacuumizing mechanism 14 comprises a vacuum pump 141 and a vacuum pipe 142, which is connected to the vacuum chamber 12 and the vacuum pump 141 respectively, and the vacuum pump 141 vacuumizes the vacuum chamber 12 through the vacuum pipe 142. In some embodiments, the vacuumizing mechanism 14 further comprises a sensor 143 arranged on the vacuum chamber 12, which is used to detect the vacuum degree of the vacuum chamber 12, and the vacuum pump 141 controls the pressure of the vacuum chamber 12 according to the vacuum degree detected by the sensor 144. Further, the vacuum chamber 12 is also connected to a vacuum breaking pipe 144, which is used to break the vacuum of the vacuum chamber 12, i.e. opening the vacuum breaking pipe 144 to make the vacuum chamber 12 communicate with the external environment and be in the normal pressure state. In this context, it should be understood that the normal pressure is not an absolute standard atmospheric pressure, but due to different geographical locations, sea levels, temperatures, etc., the actual atmospheric pressure will also be different from the standard atmospheric pressure, so the application does not have a specific limitation on the pressure value of the normal pressure. The negative pressure condition for preparing microneedles in this embodiment is not particularly limited. In addition, a vacuum valve can be arranged on the vacuum chamber 12 and connected to the vacuum pipe 142 to control the opening and closing of the vacuum pipe 142. A vacuum breaking valve can also be arranged on the vacuum chamber 12 and connected to the vacuum breaking pipe 144 to control the opening and closing of the vacuum breaking pipe 144.

[0077] The filling mechanism 13 is used to release the solution for preparing microneedles. The filling mechanism 13 is at least partially arranged in the vacuum chamber 12 and is used to deliver the solution for preparing microneedles to the vacuum chamber 12, so that the solution is poured on the screen plate 17 and the microneedle mold 11. In this embodiment, the filling mechanism 13 comprises a filling needle 131 and a filling pipe 132, one end of the filling pipe 132 extends into the vacuum chamber 12 and is connected to the filling needle 131. The filling needle 131 is used to release the solution for preparing microneedles. Further, the device further comprises a solution recovery pipe 133 for recovering the solution scraped from the screen plate 17. One end of the solution recovery pipe 133 extends into the vacuum chamber 12 and is connected to a solution recovery tank 134, which is used to receive the solution scraped from the screen plate 17, and then the recovered solution is recovered through the solution recovery pipe 133, and the recovered solution can be reused or not. By arranging the solution recovery pipe 133, the burden on the machine can be reduced, and frequent shutdown for cleaning is not required, thereby improving the efficiency of the machine.

[0078] The scraper mechanism 16 comprises a scraper 161, which is used to contact the screen plate 17 and move relative to the screen plate 17 to scrape the solution on the surface of the screen plate 17.

[0079] In some embodiments, as Figure 11As shown, the scraper 161 is arranged in linear contact with the mesh plate 17, preferably the scraper 161 is arranged perpendicularly with the mesh plate 17. By horizontal movement of the scraper 161 relative to the mesh plate 17 and the microneedle mold 11, when one side of the scraper 161 is in linear contact with the surface of the mesh plate 17, the solution on the surface of the mesh plate 17 is scraped off by horizontal movement of the scraper 161.

[0080] In some other embodiments, as shown, Figure 4 As shown, the scraper 161 is arranged in surface contact with the mesh plate 17, preferably the scraper 161 is arranged parallel with the mesh plate 17. By horizontal movement of the scraper 161 relative to the mesh plate 17 and the microneedle mold 11, when the scraper 161 is in surface contact with the surface of the mesh plate 17, the solution on the surface of the mesh plate 17 is scraped off by friction between the plane of the scraper 161 and the surface of the mesh plate 17. When the scraper 161 is arranged parallel with the mesh plate 17, the scraper 161 also has mesh holes, and the mesh holes on the scraper 161 are aligned with the mesh holes on the mesh plate 17. In actual operation, the mesh plate 17 is first arranged on the microneedle mold 11, then the scraper 161 is arranged on the mesh plate 17, and the mesh holes on the scraper 161, the mesh holes on the mesh plate 17 and the grooves on the microneedle mold 11 are aligned. Subsequently, after perfusion of the solution under negative pressure, the scraper 161 is driven to move horizontally relative to the mesh plate 17 and the microneedle mold 11, so that the scraper 161 is arranged staggered with the mesh plate 17, so that the mesh holes on the scraper 161 are not connected with the mesh holes on the mesh plate 17, thereby scraping off the excess solution on the surface of the mesh plate 17.

[0081] As a preferred solution, the mesh plate loading mechanism 15 is used to drive the mesh plate 17 to move to place the mesh plate 17 on the microneedle mold 11, and also used to remove the mesh plate 17 from the microneedle mold 11. The mesh plate 17 can be pre-loaded on the microneedle mold 11 outside the vacuum chamber 12, or after the microneedle mold 11 enters the vacuum chamber 12, the mesh plate 17 is accurately positioned and loaded on the microneedle mold 11 by the mesh plate loading mechanism 15 arranged in the vacuum chamber 12. The mesh plate loading mechanism 15 is detachably connected with the mesh plate 17, such as buckle connection or screw connection, etc. Further, the solution recovery groove 134 is arranged on the mesh plate loading mechanism 15 and used to be arranged on one side of the mesh plate 17.

[0082] The apparatus for preparing microneedles preferably includes a coarse positioning mechanism 18 and a rotary stage 19. The rotary stage 19 is disposed within the vacuum chamber 12, and the coarse positioning mechanism 18 is mounted on the rotary stage 19. The coarse positioning mechanism 18 is used to support and coarsely position the microneedle mold 11 during vacuum infusion. The coarse positioning mechanism 18 can be a substrate with positioning grooves on it, the shape of which matches the shape of the microneedle mold. The rotary stage 19 can rotate around its own axis to precisely position the microneedle mold 11. If the position of the microneedle mold 11 shifts after being placed on the substrate, it can be rotated to the target position by the rotary stage 19.

[0083] The apparatus for preparing microneedles preferably further includes a visual recognition device 20 for identifying the position of the microneedle mold 11. Preferably, the apparatus for preparing microneedles also includes a control device 21, communicatively connected to the visual recognition device 20 and the stencil loading mechanism 15. The control device 21 is used to control the stencil loading mechanism 15 to drive the stencil 17 to move and precisely position the stencil 17 onto the microneedle mold 11 based on the position information of the microneedle mold 11 identified by the visual recognition device 20.

[0084] The visual recognition device 20 may include at least one camera 22 and at least two alignment marks 23. The camera 22 is disposed within the vacuum chamber 12, and the at least two alignment marks 23 are disposed on the microneedle mold 11, preferably arranged diagonally on the microneedle mold 11. The camera 22 is used to acquire image information of the two alignment marks 23. The visual recognition device 20 identifies the position of the microneedle mold 11 based on the image information of the two alignment marks 23, thereby causing the control device 21 to control the stencil loading mechanism 15 to drive the stencil 17 to move and precisely position it on the microneedle mold 11 based on the identified position information of the microneedle mold 11. When aligning the stencil 17 with the microneedle mold 11, the center of each groove 111 on the microneedle mold 11 is aligned with the center of a corresponding mesh hole on the stencil 17.

[0085] Next reference Figures 8 to 13 . Figure 8 The microneedle mold 11 before casting is shown. The microneedle mold 11 is made of an elastic material to give it good deformation recovery ability (i.e., good elasticity). Preferably, the microneedle mold 11 is made of silicone. The surface of the microneedle mold 11 is provided with a number of tiny grooves 111, the shape, size, number, and arrangement of which are matched to the shape, size, number, and arrangement of the microneedle body to be prepared.

[0086] Figure 9The process of moving the mesh plate 17 downward in the direction of arrow A1, preferably driven by the mesh plate loading mechanism 15, so as to gently position the mesh plate 17 on the microneedle mold 11 is shown.

[0087] Figure 10 The process of pouring the solution into the mesh plate 17 and the microneedle mold 11 through the pouring mechanism 13 in the direction of arrow A2 is shown, and the solution enters the microneedle mold 11 through the mesh holes on the mesh plate 17.

[0088] Figure 11 The process of removing the excess solution on the surface of the mesh plate 17 by moving the scraper 161 in the horizontal direction in the direction of arrow A3 is shown. There is no particular restriction on the pressure when the scraper 161 contacts the mesh plate 17 during the scraping process.

[0089] Figure 12 The process of moving and removing the mesh plate 17 upward in the direction of arrow A4, preferably by driving the mesh plate 17 to move by the mesh plate loading mechanism 15, is shown.

[0090] Figure 13 The microneedle mold 11 filled with the solution after the mesh plate 17 is removed is shown.

[0091] It should be known that the present application can quickly and effectively remove the excess solution on the surface of the microneedle mold 11, realize the rapid preparation of the microneedle body, and ensure the forming quality of the microneedle body, without the need for repeated scraping operations, thereby improving the efficiency of microneedle preparation. By providing the mesh plate 17 on the microneedle mold 11 and scraping the solution on the surface of the mesh plate 17, and then removing the mesh plate 17, the mesh plate 17 is removed together with the solution on the mesh plate 17. After the mesh plate 17 is removed, there is basically no excess solution on the surface of the microneedle mold 11, and the solution in the grooves 111 of the microneedle mold 11 will not be reduced, which can ensure that each groove 111 is filled with solution, thereby ensuring the product quality of the microneedle, and without the need for repeated operations by the scraper 161, the efficiency of microneedle preparation is improved. Moreover, the scraper 161 directly operates on the mesh plate 17, which reduces the difficulty of force control of the scraper 161, making the operation more convenient.

[0092] Referring back to Figure 1 and Figure 2The device for preparing microneedles preferably further comprises an X-direction movement mechanism 24 and a Y-direction first movement mechanism 25, wherein the X-direction movement mechanism 24 is preferably independently provided from the Y-direction first movement mechanism 25, and of course in other embodiments, the X-direction movement mechanism 24 can also be provided on the Y-direction first movement mechanism 25. In the present embodiment, the rotary movement table 19 is provided on the Y-direction first movement mechanism 25, and the X-direction movement mechanism 24 is independently provided from the Y-direction first movement mechanism 25, the rotary movement table 19 is driven by the Y-direction first movement mechanism 25 to move horizontally along the Y-direction, and the screen plate loading mechanism 15 and / or the scraping plate mechanism 16 are driven by the X-direction movement mechanism 24 to move horizontally along the X-direction. Further, the screen plate loading mechanism 15 and / or the scraping plate mechanism 16 are provided on the X-direction movement mechanism 24.

[0093] The device for preparing microneedles preferably further comprises a Z-direction first movement mechanism 26 provided on the X-direction movement mechanism 24. The screen plate loading mechanism 15 and / or the scraping plate mechanism 16 are driven by the Z-direction first movement mechanism 26 to move vertically along the Z-direction. Thus, the X-direction movement mechanism 24, the Y-direction first movement mechanism 25 and the Z-direction first movement mechanism 26 form a three-axis movement module, thereby simplifying the movement structure and reducing the size of the device. Wherein the X-direction, the Y-direction and the Z-direction are perpendicular to each other. Of course in other embodiments, the vertical movement and the horizontal movement of the screen plate loading mechanism 15 and the scraping plate mechanism 16 can be respectively realized by different movement mechanisms.

[0094] Further, the device for preparing microneedles further comprises a Y-direction second movement mechanism 27 provided on the Z-direction first movement mechanism 26. The scraping plate mechanism 16 is provided on the Y-direction second movement mechanism 27, and the scraping plate mechanism 16 is driven by the Y-direction second movement mechanism 27 to move horizontally along the Y-direction. The device for preparing microneedles further comprises a Z-direction second movement mechanism 28 provided on the Y-direction second movement mechanism 27. The scraping plate mechanism 16 is provided on the Z-direction second movement mechanism 28, and the scraping plate mechanism 16 is driven by the Z-direction second movement mechanism 28 to move vertically along the Z-direction.

[0095] In the present embodiment, the screen plate 17 is relatively thin and is easy to deform. In order to ensure that the screen plate 17 covers the microneedle mold 11, the screen plate 17 is preferably tensioned by a tensioning mechanism, so that the screen plate 17 covers the microneedle mold 11 in a flat state, and ensures that the screen plate 17 fully adheres to the microneedle mold 11. The tensioning mechanism is preferably provided on the screen plate loading mechanism 15.

[0096] Figure 5 The screen plate loading mechanism 15 of the preferred embodiment of the present application is shown. As shown in FIG. 2, the screen plate loading mechanism 15 comprises a screen plate 17, a screen plate loading mechanism 15 and a scraping plate mechanism 16. Figure 5As shown, the screen loading mechanism 15 can include a screen loading frame 151 and a screen fixing block 152, through which the edges of the screen 17 are clamped and fixed. The screen loading frame 151 and the screen fixing block 152 are detachably connected, and can be connected by locking screws 153. The screen loading frame 151 is configured as a hollow structure so that the scraper 161 can be in contact with the screen 17. The shape of the screen loading frame 151 is not limited to a U-shaped structure. Preferably, the tensioning mechanism includes a tensioning piece 154 and an adjusting screw 155. The tensioning piece 154 is detachably fixed to the screen fixing block 152, such as by a locking screw 153, and is connected to the screen loading frame 151 by the adjusting screw 155. The relative position between the tensioning piece 154 and the screen loading frame 151 is adjusted by the adjusting screw 155, and the tensioning piece 154 is pre-tightened with the screen loading frame 151 to tension the screen 17. In this embodiment, the tensioning piece 154 can be provided on at least one side of the screen 17. Preferably, the tensioning piece 154 has a through groove, and one side of the screen loading frame 151 has a fixed arm 1511 for clamping into the groove. The shape of the groove is preferably matched with the shape of the fixed arm 1511. The number of adjusting screws 155 can be one or more. Of course, in addition to the tensioning method exemplified here, other methods can also be used, and the structure of the tensioning mechanism is not limited in the present application.

[0097] The screen loading mechanism 15 preferably further includes a pressure sensor 156 for detecting the pressure between the screen 17 and the microneedle mold 11. The pressure sensor 156 can be provided on the screen 17 or the screen loading frame 151 or other suitable positions. According to the detected pressure between the screen 17 and the microneedle mold 11, the pressure of the screen 17 when it is attached to the microneedle mold 11 can be controlled to ensure effective attachment of the two. Preferably, the control device 21 is preferably in communication with the pressure sensor 156 to control the screen loading mechanism 15 to adjust the attachment state between the screen 17 and the microneedle mold 11 according to the detected pressure between the screen 17 and the microneedle mold 11.

[0098] Figure 6 The scraper mechanism 16 of the preferred embodiment of the present application is shown. As shown in FIG. 6, the scraper mechanism 16 includes a scraper 161 and a scraper driving mechanism 162. The scraper 161 is connected to the scraper driving mechanism 162, and the scraper driving mechanism 162 is connected to the control device 21. The control device 21 controls the scraper driving mechanism 162 to drive the scraper 161 to move along the screen 17 to scrape the screen 17. Figure 6As shown, the squeegee mechanism 16 comprises a squeegee 161, a connecting member 162, a first base 163 and a second base 164, wherein the connecting member 162 is an optional structure. The squeegee 161 is detachably or non-detachably connected with the first base 163, and optionally, the squeegee 161 is connected with the connecting member 162, the connecting member 162 is detachably or non-detachably connected with the first base 163, and the first base 163 is movably connected with the second base 164, so as to realize the up-and-down jumping and turning movement of the squeegee 161. Preferably, the first base 163 is provided with a ball pin 1631, and the second base 164 is provided with a slot hole 1641 matched with the ball pin 1631. Thus, the first base 163 and the second base 164 are connected in a ball joint, so that the squeegee 161 can rotate with the ball center of the ball pin 1631 as the rotation center, so as to adjust the contact state between the screen plate 17 and the squeegee 161. Meanwhile, the squeegee mechanism 16 further comprises an elastic structure for providing elastic force to the squeegee 161, so that the squeegee 161 can adaptively adjust the position relative to the screen plate 17. Further, the connecting member 162 can be locked with the first base 162 by a fixing screw 168. The number of the fixing screws 168 is not required. Of course, in addition to the ball pin, other movable connection modes can be used to realize the swinging of the first base relative to the second base, such as setting a swing joint, and the first base swings around the swing joint, and the present application does not limit this.

[0099] The elastic structure can comprise a plurality of springs 165, such as two, three or four symmetrically arranged springs 165. The springs 165 are installed on the first base 163, the first base 163 is provided with a plurality of symmetrically distributed first spring installation holes 1632, one end of the plurality of springs 167 is telescopically arranged in the first spring installation hole 1632, and a fixing rod 166 is arranged in the first spring installation hole 1632 and passes through the spring 165. Similarly, the second base 164 is provided with a plurality of symmetrically distributed second spring installation holes 1642, and the other end of the spring 165 is telescopically arranged in the second spring installation hole 1642. The size of the inner hole of the spring 165 is slightly larger than the size of the fixing rod 168, so that the spring 165 can still be telescopically arranged on the fixing rod 168, but the fixing rod 166 can appropriately limit the rotation of the ball pin 1631 around the vertical axis, but it should be understood that the rotation of the ball pin 1631 around the vertical axis is not completely limited. At least one end of the fixing rod 166 is fixedly connected with the first base 162 or the second base 163.

[0100] It should be understood that the scraper 161 can rotate slightly along the ball head, thereby adjusting the contact state between the scraper 161 and the screen 17, while the spring 165 plays an adaptive adjustment role, allowing the scraper 161 to adaptively change its position relative to the screen 17. In this way, even if the scraper 161 and the screen 17 are not parallel, effective contact between the scraper 161 and the screen 17 can be ensured, so that the solution on the screen 17 can be fully scraped off by the scraper 161. The scraper mechanism 16 preferably includes a dust cover 167, which is disposed between the first base 163 and the second base 164, and is used to seal the hollow area between the first base 162 and the second base 163 to ensure that the ball head pin and the spring can work normally.

[0101] Figure 7 A scraper mechanism 16 according to another preferred embodiment of the present invention is shown. For example... Figure 7 As shown, the difference from the above embodiment is that the fixing rod 166 inside the spring 165 is removed. Instead, a limiting pin 1643 is provided on the second base 164, and a pin hole that mates with the limiting pin 1643 is provided on the ball head pin 1631. The pin hole can be spherical or cylindrical. The size of the limiting pin 1643 is smaller than the size of the pin hole, so as to limit the movement of the ball head pin 1631 and prevent the ball head pin 1631 from swinging too much. The axis of the limiting pin 1643 is inclined relative to the vertical direction, and the angle of inclination is not required.

[0102] This embodiment does not impose any particular limitation on the type of control device 21. It can be hardware that performs logic operations, such as a microcontroller, microprocessor, programmable logic controller (PLC), or field-programmable gate array (FPGA), or software programs, functional modules, functions, object libraries, or dynamic-link libraries that implement the above functions on a hardware basis. Alternatively, it can be a combination of the above. Those skilled in the art should understand how to specifically implement communication between the control device 21 and other devices based on the content disclosed in this application. Furthermore, while the use of control device 21 is the preferred embodiment, those skilled in the art can use other technical means, such as manual control or mechanical control, to achieve the same technical effect.

[0103] Figure 1 A flowchart illustrating the preparation of microneedles according to a preferred embodiment of the present invention is shown. For example... Figure 1 As shown, the present invention also provides a method for preparing microneedles, comprising the following steps:

[0104] Step S1: Provide the microneedle mold to be cast.

[0105] The microneedle mold is a female mold with grooves on the surface, the size and shape of the grooves match the microneedle body. The microneedle is not limited to a dissolvable polymer microneedle, the microneedle can pierce the human stratum corneum to form a channel conducive to drug delivery, thereby promoting the transdermal absorption of drugs. The shape of the microneedle body is not limited in the present application, including but not limited to a needle body with a convex structure at the tip, which can be a convex structure with a sharp shape or a convex structure without a sharp shape; the needle body includes but is not limited to a conical shape, a multi-prism shape, or a shuttle shape. The microneedle mold provided in the present embodiment can be used to prepare a split microneedle, that is, the microneedle body and the base are separated, the needle body is prepared first, and then the needle body is arranged on the base. In other embodiments, it can also be used to prepare a microneedle with an integrated microneedle body and base.

[0106] Step S2: Place a screen on the microneedle mold.

[0107] The microneedle mold is first placed in the vacuum chamber, and then the screen is placed on the microneedle mold so that the screen covers all the grooves on the microneedle mold. The screen can be placed on the microneedle mold manually or mechanically, and the mechanical method is preferred to accurately position the screen on the microneedle mold. In actual operation, the screen can be placed on the microneedle mold before vacuuming, and then the screen and the microneedle mold are vacuumed together, or the screen and the microneedle mold are vacuumed, and then the vacuumed screen is placed on the vacuumed microneedle mold.

[0108] The size of the screen is not limited in the present application, and the screen can be larger than or equal to the microneedle mold, or smaller than the microneedle mold. Preferably, each groove on the surface of the microneedle mold is covered with a mesh hole, that is, the screen is provided with through mesh holes, and the positions of the mesh holes on the screen correspond one-to-one to the positions of the grooves on the microneedle mold, so that the microneedle solution can pass through the mesh holes to reach the grooves. The side cross-sectional shape of the screen can be the same as or different from the side cross-sectional shape of the microneedle mold, and in a preferred case, the side cross-sectional shape and size of the screen are the same as the side cross-sectional shape and size of the microneedle mold, but the shape of the microneedle mold and the screen is not limited to the rectangular plate shown in the figure, and can also be other suitable shapes.

[0109] The size of the mesh hole on the screen is usually greater than or equal to the size of the groove on the microneedle mold, and the shape of the mesh hole can be the same as or different from the shape of the groove, and the shape of the mesh hole is preferably the same as the shape of the groove. The shape of the mesh hole is the same as the shape of the groove, which means that the cross-sectional shape of the mesh hole is the same as the cross-sectional shape of the groove, for example, the groove is a right quadrangular pyramid, at this time, the cross-sectional shape of the top of the groove adjacent to the surface of the mold is a square, and the mesh hole is a square mesh hole.

[0110] The material of the mesh plate should be selected to have certain rigidity and not react with the drug, and at the same time not to contaminate the drug, for example, the mesh plate can be made of steel plate. The mesh plate is a thin plate, and the thickness is preferably 0.05mm to 0.2mm. Preferably, the surface of the mesh plate is provided with a hydrophobic layer, and the entire surface is usually provided with the hydrophobic layer, and more preferably the hole wall of the mesh hole is provided with the hydrophobic layer. The arrangement of the hydrophobic layer helps the mesh plate to be smoothly separated from the microneedle mold, and avoids that the mesh plate takes the solution in the groove during the process of removing the mesh plate. The application does not have requirements for the arrangement method of the hydrophobic layer, which can be immersion, spraying and the like. The material of the hydrophobic layer can be at least one of PTFE (polytetrafluoroethylene), PFA (tetrafluoroethylene and perfluoroalkoxy vinyl ether copolymer), FEP (fluorinated ethylene propylene copolymer), and ETFE (copolymer of ethylene and tetrafluoroethylene).

[0111] Further in the process of arranging the mesh plate, the mesh plate is aligned with the microneedle mold. There are various ways to align the mesh plate and the microneedle mold, such as sensor alignment, light path alignment, machine vision alignment and the like. In an embodiment, two alignment marks can be arranged on the microneedle mold, and the two alignment marks are preferably arranged at diagonal lines, and the positions of the two alignment marks are identified by a visual recognition device, and then the position of the mesh plate is positioned according to the positions of the two alignment marks, so as to accurately position the mesh plate on the microneedle mold. In other embodiments, a laser sensor can be arranged on an external mechanism such as a rack, and the position of the microneedle mold is identified by receiving the laser emitted by the mark point on the microneedle mold through the laser sensor, and then the position of the mesh plate is positioned according to the position of the microneedle mold.

[0112] Step S3: under the condition of negative pressure, the solution for preparing microneedles is cast to the microneedle mold with the surface covered by the mesh plate.

[0113] It should be understood that after the vacuum chamber is evacuated, the solution for preparing microneedles is cast to the microneedle mold with the surface covered by the mesh plate by using the filling mechanism. The solution for preparing microneedles has a certain viscosity, and preferably the viscosity of the solution is 10-6000mPa.s (millipascal.second). The solution includes but is not limited to polymer solution, and the application does not have special limitations on the type of polymer solution. Preferably, the solution is a polymer aqueous solution, a prepolymer solution, a monomer solution or a monomer mixed solution.

[0114] Step S4: after the solution is cast, the squeegee can be in contact with the mesh plate under the condition of negative pressure or broken vacuum, and the excess solution on the surface of the mesh plate is scraped off by the horizontal movement of the squeegee relative to the mesh plate.

[0115] In a preferred embodiment, after the solution is cast, the excess solution on the surface of the mesh plate is scraped off by the squeegee when the vacuum chamber is in the state of broken vacuum.

[0116] Compared with the prior art of directly scraping the excess solution on the surface of the microneedle mold by the scraper, the excess solution on the surface of the screen plate is directly scraped, without the need for strict control of the force of the scraper, and the force of the scraper can be large or small, thereby reducing the operation difficulty and improving the production efficiency. It should be understood that if the excess solution on the surface of the screen plate is not scraped, the "wire drawing" phenomenon will occur when the screen plate is removed, and the solution in the groove of the microneedle mold will also be taken away by the screen plate. After the excess solution on the surface of the screen plate is scraped, the "wire drawing" problem can be reduced or even avoided, and the solution can be ensured to fill the groove.

[0117] Step S5: After the scraping of the solution is completed, the screen plate and the scraper are removed.

[0118] First, the scraper is scraped in sequence, and then the screen plate is removed in sequence. During the removal of the screen plate, the screen plate and the solution carried on the screen plate are also removed. After the screen plate is removed, the surface of the microneedle mold is free of excess solution, and the groove is filled with solution. This method can effectively remove the excess solution on the surface of the microneedle mold and fill the groove in the microneedle mold with solution, so that the polymer solution can be quickly and uniformly injected into the microneedle mold, the quality of the microneedle product is effectively improved, the waste rate is reduced, and the efficiency is improved.

[0119] The removal of the screen plate is mainly completed in a mechanical manner, and the screen plate is removed by being lifted upwards, so that the screen plate and the solution in the screen hole are removed together. The removal direction of the screen plate is preferably perpendicular to the microneedle mold.

[0120] Step S6: After the screen plate is removed, the microneedle mold with the cast solution is obtained.

[0121] Step S7: The microneedle mold with the cast solution is broken in vacuum, and then the microneedle mold with the cast solution is dried and solidified, such as natural drying or artificial drying. After drying, demolding is performed, and a microneedle body is obtained.

[0122] Further, when the scraper is arranged, the scraper is in linear contact or surface contact with the screen plate, which can effectively remove the excess solution on the screen plate.

[0123] Further, when the screen plate is arranged, a tensioning mechanism is used to tension the screen plate, so that the screen plate covers the microneedle mold in a flat state, thereby ensuring that the screen plate can be completely attached to the microneedle mold and ensuring the quality of microneedle molding.

[0124] Further, when the screen plate is arranged, a pressure sensor is used to detect the pressure between the screen plate and the microneedle mold, so as to adjust the attachment state between the screen plate and the microneedle mold according to the pressure, thereby ensuring that the screen plate can be fully attached to the microneedle mold and ensuring the quality of microneedle molding.

[0125] Further, before the mesh plate is placed on the microneedle mold, the method further comprises:

[0126] A visual recognition device is used to recognize the position of the microneedle mold, so as to position the mesh plate on the microneedle mold according to the position of the microneedle mold.

[0127] Further, when the solution on the surface of the mesh plate is scraped, the scraper is capable of self-adapting the position relative to the mesh plate. Even if the scraper is not parallel to the mesh plate, the scraper can still ensure sufficient contact with the mesh plate to avoid the problem of incomplete scraping of the solution due to no contact.

[0128] By using the device and method for preparing microneedles provided by the application, the solution on the surface of the microneedle mold can be better removed, the surface of the microneedle mold is ensured to be free of solution, and each groove of the microneedle mold is ensured to be filled with solution without the problem of being not filled, thereby improving the quality of the microneedle forming, without the need for repeated scraping operations, improving the efficiency of the microneedle preparation, and reducing the production cost.

[0129] The above description is only a description of the preferred embodiments of the application, and does not limit the scope of the application. Any modification or change made by a person skilled in the art according to the above disclosure is within the protection scope of the application.

Claims

1. An apparatus for preparing microneedles, characterized in that, Includes microneedle molds, vacuum chambers, filling mechanisms, scraper mechanisms, and screens; The surface of the microneedle mold is provided with grooves that match the microneedle body; The mesh plate is used to be disposed on the microneedle mold and to cover the groove; The filling mechanism is at least partially disposed within the vacuum chamber and is used to release the solution for preparing microneedles, the released solution being used to flow into the microneedle mold via the mesh plate; The scraper mechanism includes a scraper, a first base, and a second base. The scraper is configured to make line contact or surface contact with the mesh plate and move relative to the mesh plate to scrape off the solution on the surface of the mesh plate. The scraper mechanism also includes a first base and a second base. The scraper is detachably fixedly connected to the first base, and the first base and the second base are movably connected by a ball head pin.

2. The apparatus for preparing microneedles according to claim 1, characterized in that, The mesh size on the stencil is greater than or equal to the size of the groove on the microneedle mold.

3. The apparatus for preparing microneedles according to claim 2, characterized in that, The side profile shape of the mesh is the same as the side profile shape of the groove.

4. The apparatus for preparing microneedles according to claim 1, characterized in that, The thickness of the mesh plate is 0.05mm to 0.2mm.

5. The apparatus for preparing microneedles according to claim 1, characterized in that, It also includes a vacuuming mechanism and / or a stencil loading mechanism, wherein the vacuuming mechanism is used to evacuate the vacuum chamber, the stencil loading mechanism is used to drive the stencil to move and place the stencil on the microneedle mold, and the stencil loading mechanism is also used to remove the stencil from the microneedle mold.

6. The apparatus for preparing microneedles according to claim 5, characterized in that, The mesh loading mechanism includes a mesh loading frame and a mesh fixing block. The mesh loading frame and the mesh fixing block work together to clamp and fix the edge of the mesh. The mesh loading frame has a hollow structure.

7. The apparatus for preparing microneedles according to claim 6, characterized in that, It also includes a tensioning mechanism, which is disposed on the mesh loading mechanism and is used to tension the mesh so that the mesh covers the microneedle mold in a flat state.

8. The apparatus for preparing microneedles according to claim 7, characterized in that, The tensioning mechanism includes a tensioning element and an adjusting screw. The tensioning element is used for a detachable fixed connection with the mesh plate fixing block. The tensioning element is also used for connection with the mesh plate loading frame via the adjusting screw. The adjusting screw is used to adjust the relative position between the tensioning element and the mesh plate loading frame.

9. The apparatus for preparing microneedles according to claim 5, characterized in that, The stencil loading mechanism includes a pressure sensor for detecting the pressure between the stencil and the microneedle mold and generating pressure information.

10. The apparatus for preparing microneedles according to claim 9, characterized in that, It also includes a control device that is communicatively connected to the pressure sensor. The control device is used to control the mesh loading mechanism to adjust the fit between the mesh and the microneedle mold based on the pressure information detected by the pressure sensor.

11. The apparatus for preparing microneedles according to claim 1, characterized in that, It also includes a return line, one end of which extends into the vacuum chamber and is connected to a solution recovery tank for receiving the solution scraped off the screen.

12. The apparatus for preparing microneedles according to claim 11, characterized in that, It also includes a stencil loading mechanism, which is used to drive the stencil to move and place the stencil on the microneedle mold, and the stencil loading mechanism is also used to remove the stencil from the microneedle mold; The solution recovery tank is mounted on the screen loading mechanism and is positioned on one side of the screen.

13. The apparatus for preparing microneedles according to claim 1, characterized in that, It also includes a coarse positioning mechanism and a rotary table. The rotary table is disposed in the vacuum chamber, and the coarse positioning mechanism is disposed on the rotary table. The coarse positioning mechanism is used to place the microneedle mold and perform coarse positioning. The rotary table can rotate to achieve fine positioning of the microneedle mold.

14. The apparatus for preparing microneedles according to claim 13, characterized in that, The device includes an X-axis motion mechanism, a Y-axis first motion mechanism, and a Z-axis first motion mechanism. The Z-axis first motion mechanism is mounted on the X-axis motion mechanism. The X-axis motion mechanism and the Y-axis first motion mechanism are independently configured. The rotary motion table is mounted on the Y-axis first motion mechanism. The Y-axis first motion mechanism is used to drive the rotary motion table to move horizontally along the Y-axis. The X-axis motion mechanism is used to drive the mesh plate and / or the scraper to move horizontally along the X-axis. The Z-axis first motion mechanism is used to drive the mesh plate and / or the scraper to move vertically along the Z-axis. The X, Y, and Z axes are perpendicular to each other.

15. The apparatus for preparing microneedles according to claim 14, characterized in that, It also includes a second Y-axis motion mechanism and a second Z-axis motion mechanism. The second Y-axis motion mechanism is disposed on the first Z-axis motion mechanism, and the second Z-axis motion mechanism is disposed on the second Y-axis motion mechanism. The second Y-axis motion mechanism is used to drive the scraper to move horizontally along the Y-axis, and the second Z-axis motion mechanism is used to drive the scraper to move vertically along the Z-axis.

16. The apparatus for preparing microneedles according to claim 1, characterized in that, It also includes a visual recognition device and a control device with communication connection. The visual recognition device is used to identify the position of the microneedle mold, and the control device is used to locate the position of the stencil relative to the microneedle mold based on the position of the microneedle mold.

17. The apparatus for preparing microneedles according to claim 16, characterized in that, The visual recognition device includes a camera and at least two alignment marks. The camera is disposed in the vacuum chamber, and the at least two alignment marks are disposed on the microneedle mold. The camera is used to acquire image information of the at least two alignment marks, and the visual recognition device is used to identify the position of the microneedle mold based on the image information of the at least two alignment marks.

18. The apparatus for preparing microneedles according to claim 17, characterized in that, At least two of the alignment marks are arranged diagonally on the microneedle mold.

19. The apparatus for preparing microneedles according to claim 1, characterized in that, The scraper mechanism also includes an elastic structure for providing elastic force to the scraper so that the scraper can adaptively adjust its position relative to the mesh plate.

20. The apparatus for preparing microneedles according to claim 19, characterized in that, The elastic structure includes multiple springs, one end of which is retractably disposed on the first base and the other end of which is retractably disposed on the second base.

21. The apparatus for preparing microneedles according to claim 20, characterized in that, A fixing rod is inserted inside the spring, at least one end of which is fixedly connected to the first base or the second base, and the spring is configured to extend and retract on the fixing rod.

22. The apparatus for preparing microneedles according to claim 1, characterized in that, The scraper mechanism also includes a dust cover, which is disposed between the first base and the second base and is used to seal the hollow area between the first base and the second base.

23. The apparatus for preparing microneedles according to claim 20, characterized in that, The second base is provided with a limiting pin, the ball head pin is provided on the first base, the ball head pin is provided with a pin hole that cooperates with the limiting pin, and the axis of the limiting pin is inclined relative to the vertical direction.

24. The apparatus for preparing microneedles according to claim 1, characterized in that, The entire surface of the mesh plate is provided with a hydrophobic layer, and the walls of the mesh holes of the mesh plate are also provided with a hydrophobic layer.

25. A method for preparing microneedles, characterized in that, include: A microneedle mold is provided, wherein the surface of the microneedle mold is provided with a groove that matches the microneedle body; The microneedle mold is placed in a vacuum chamber, and a mesh plate is placed on the microneedle mold so that the mesh plate covers the groove on the microneedle mold; The vacuum chamber is evacuated, and a solution for preparing microneedles is poured into the microneedle mold covered by the mesh plate through a filling mechanism. The released solution flows into the microneedle mold through the mesh plate. The scraper is brought into line contact or surface contact with the mesh plate, and the scraper is moved horizontally relative to the mesh plate to scrape off the solution on the surface of the mesh plate. The scraper is detachably fixed to the first base, and the first base and the second base are movably connected by a ball head pin. Remove the mesh and the scraper to obtain a microneedle mold with the solution poured in; The microneedle mold after the solution has been poured is dried under a vacuum condition. After drying, it is demolded to obtain the microneedle body.

26. The method for preparing microneedles according to claim 25, characterized in that, When setting the stencil, a tensioning mechanism is used to tension the stencil so that it covers the microneedle mold in a flat state.

27. The method for preparing microneedles according to claim 25, characterized in that, When setting the stencil, a pressure sensor is used to detect the pressure between the stencil and the microneedle mold, so as to adjust the bonding state between the stencil and the microneedle mold according to the pressure.

28. The method for preparing microneedles according to claim 25, characterized in that, Before placing the mesh plate onto the microneedle mold, the method further includes: The position of the microneedle mold is identified using a visual recognition device, so as to locate the position of the stencil relative to the microneedle mold based on the position of the microneedle mold.

29. The method for preparing microneedles according to claim 25, characterized in that, When scraping the solution off the surface of the screen, the scraper is able to adaptively adjust its position relative to the screen.

Images