A planar microneedle, a microneedle patch, a manufacturing apparatus, a standing apparatus, and a preparation method

Abstract

The present application relates to a kind of plane microneedle, including substrate layer and microneedle that can be reversedly arranged on substrate layer, microneedle includes needle tip, needle seat and the middle part connecting needle tip and needle seat, needle tip direction of orientation with substrate layer extension direction is identical.The present application also relates to a kind of plane microneedle manufacturing equipment, plane microneedle preparation method, microneedle patch and microneedle patch erecting equipment.Its beneficial effect is, needle tip slot direction of orientation with needle seat slot is horizontal direction, to reduce the depth of forming groove, and the ratio of maximum depth and maximum length of forming groove, facilitate to accurately fill the needle tip slot in forming groove with drug liquid, avoid drug liquid splash pollution middle part groove and needle seat groove, and the microneedle formed only at needle tip is loaded with drug.

Description

Technical Field

[0001] This invention relates to the field of microneedle technology, and in particular to a planar microneedle, a microneedle patch, manufacturing equipment, vertical equipment, and preparation method. Background Technology

[0002] Currently, metal needles are commonly used for drug injections. However, the pain and fear associated with using metal needles make them unacceptable to some people (especially children). Therefore, microneedle patches have begun to be used.

[0003] Microneedle patches mainly consist of a basal layer and microneedles placed on the basal layer. When using them, the side of the microneedle patch with microneedles is pressed and applied to the skin. Because the microneedles are relatively short, they do not cause nerve damage or pain during use, and are gradually gaining public acceptance.

[0004] Microneedle patches are primarily molded. Drug-loaded liquid is infused into the molding groove of the mold using high-pressure jetting or vacuum suction, directly forming microneedles extending perpendicular to the basal layer. To ensure the patient receives the preset dosage during use, the tip of the microneedle is the drug-loaded area. Due to the large depth and aspect ratio of the molding groove used to form the microneedles, the drug-loaded liquid spreads in a fan shape during jet infusion, causing it to splash onto the center and base of the corresponding microneedles within the molding groove. Alternatively, during vacuum suction infusion, the drug-loaded liquid enters the tip of the microneedle through the base and center of the corresponding microneedle within the molding groove, ensuring that the tip, center, and base of the formed microneedle are all drug-loaded. During use, the dosage injected varies depending on the depth of the microneedle penetration into the skin, making precise dosage control impossible. Furthermore, the drug-loaded liquid within the molding groove is difficult to remove, leading to contamination of the molding groove and affecting other batches of microneedles. Furthermore, due to the large depth and aspect ratio of the molding groove, the demolding resistance after microneedle molding is large, making demolding difficult.

[0005] Therefore, there is an urgent need for a microneedle that can concentrate the drug-loaded liquid at the needle tip, as well as the manufacturing equipment and preparation method for forming the microneedle. Summary of the Invention

[0006] (a) Technical problems to be solved

[0007] In view of the above-mentioned shortcomings and deficiencies of the prior art, the present invention provides a planar microneedle, a microneedle patch and manufacturing equipment, a vertical forming device and a preparation method. It solves the technical problems of the existing microneedle manufacturing equipment, where the depth and aspect ratio of the forming groove of the mold are both large, resulting in drug loading on the tip, middle and base of the formed microneedle, making it impossible to control the precise dosage and contaminating the forming groove, affecting other batches of microneedles. It also solves the technical problem that the depth and aspect ratio of the forming groove are both large, making demolding difficult.

[0008] (II) Technical Solution

[0009] To achieve the above objectives, the main technical solutions adopted by the present invention include:

[0010] In a first aspect, the present invention provides a planar microneedle, comprising a base layer and a microneedle reversibly disposed on the base layer, the microneedle comprising a needle tip, a needle seat and a middle portion connecting the needle tip and the needle seat, wherein the direction of the needle tip toward the needle seat is the same as the extension direction of the base layer.

[0011] According to the present invention, the ratio of the maximum depth of the microneedle perpendicular to the substrate to the maximum length parallel to the substrate is 1:(2-5).

[0012] According to the present invention, the microneedle includes a first surface, a second surface, and a third surface, the first surface and the substrate layer are located in the same plane, the third surface is connected to the substrate layer, and the microneedle is capable of flipping around the connection between the third surface and the substrate layer so that the third surface is flipped to be parallel to the substrate layer.

[0013] According to the present invention, the angle between the first surface and the third surface is 45°-90°, the angle between the second surface and the third surface is 60°-90°, and the angle between the first surface and the second surface is 15°-45°.

[0014] According to the present invention, the second surface extends outward along the width direction of the microneedle to form a protrusion.

[0015] Secondly, embodiments of the present invention also provide a manufacturing apparatus for planar microneedles, including a base, a mold, and a panel located above the base;

[0016] The top of the base is provided with a receiving groove for accommodating the mold;

[0017] The top of the mold is provided with multiple recessed grooves for forming microneedles;

[0018] The forming groove includes a needle tip groove, a needle seat groove, and a central groove connecting the needle tip groove and the needle seat groove, wherein the direction of the needle tip groove toward the needle seat groove is horizontal;

[0019] The panel is provided with a plurality of molding holes for accommodating the mold and for molding the base layer;

[0020] The top of the mold protrudes upward to form an isolation section, which is arranged circumferentially around the side wall of the forming groove;

[0021] When the mold is fitted into the receiving groove of the base, and the panel is pressed against the top of the base and the mold, the height of the isolation portion is at least the same as the height of the panel.

[0022] According to the present invention, the ratio of the maximum depth to the maximum length of the forming groove is 1:(2-5).

[0023] According to the present invention, the angle between the bottom wall of the forming groove and the top of the mold is 45°-90°, the angle between the bottom wall and the side wall of the forming groove is 60°-90°, and the angle between the side wall and the top of the mold is 15°-45°.

[0024] According to the present invention, the isolation portion extends outward along the width direction of the molding groove to form a protrusion, the protrusion being used to form the protrusion of the microneedle.

[0025] Thirdly, the present invention also provides a method for preparing planar microneedles, the method comprising the following steps:

[0026] S1: Assemble the base, mold, and panel;

[0027] S2: Inject the drug-loaded liquid into the needle tip groove of the mold and dry it to form the needle tip of the microneedle;

[0028] S3: After injecting raw material liquid into the middle groove of the mold, the needle seat groove and the forming hole of the panel, scrape the raw material liquid along the top of the panel.

[0029] The raw material liquid in the forming hole is dried to form the base layer, the raw material liquid in the needle seat groove of the mold is dried to form the base of the microneedle, and the raw material liquid in the middle groove of the mold is dried to form the middle part of the microneedle.

[0030] According to the present invention, step S3 further includes:

[0031] After injecting the raw material liquid into the molding hole of the panel, the drug-loaded liquid is scraped flat along the direction of the needle tip groove of the mold toward the needle seat groove;

[0032] Alternatively, inject raw material liquid into the molding holes of the panel until the molding holes are filled, scrape the raw material liquid along the top of the panel, and then draw a vacuum.

[0033] Alternatively, inject raw material liquid into the molding holes of the panel until the molding holes are filled, scrape the raw material liquid along the top of the panel, and then centrifuge.

[0034] Fourthly, the present invention also provides a microneedle patch, including the planar microneedles and an adhesive layer, wherein the microneedles are capable of being flipped from a first side parallel to the base layer to a third side parallel to the base layer, and the third side is adhered to the adhesive layer to form the microneedle patch.

[0035] Fifthly, the present invention also provides a microneedle application device, including the aforementioned planar microneedles, and further including a conveyor belt assembly and a microneedle flipping component;

[0036] The conveyor belt assembly is used to transport the planar microneedles and the adhesive layer;

[0037] The microneedle flipper is located at the junction of the planar microneedle and the adhesive layer;

[0038] The microneedle flipping component is used to adhere the base layer to the adhesive layer and flip the microneedle from a first side parallel to the base layer to a third side parallel to the base layer, and make the third side adhere to the adhesive layer to complete the microneedle upright shape.

[0039] (III) Beneficial Effects

[0040] The beneficial effects of this invention are:

[0041] The planar microneedle manufacturing equipment of the present invention is used in a molding groove for forming microneedles. The direction of the needle tip groove towards the needle seat groove is horizontal, which reduces the depth of the molding groove and the ratio of the maximum depth to the maximum length of the molding groove. This facilitates the precise injection of drug-loaded liquid into the needle tip groove of the molding groove, avoids splashing of drug-loaded liquid and contamination of the middle groove and the needle seat groove, and ensures that the formed microneedles are loaded with drug only at the needle tip, so as to precisely control the dosage of the microneedle patch during use. Furthermore, by reducing the depth of the molding groove and the ratio of the maximum depth to the maximum length, the demolding resistance between the microneedle and the molding groove after molding is reduced, preventing microneedle breakage, improving the yield of microneedles, and reducing costs. At the same time, because the molding groove is horizontally oriented, the demolding of the needle tip and / or the middle of the microneedle is not affected by the shape of the middle and / or the needle seat.

[0042] The method for preparing the planar microneedle manufacturing equipment of the present invention is simple to operate and highly efficient. Attached Figure Description

[0043] Figure 1 This is a perspective view of the manufacturing equipment for planar microneedles according to Embodiment 3 of the present invention;

[0044] Figure 2 for Figure 1 Exploded view;

[0045] Figure 3 for Figure 2 Exploded view of the mold and planar microneedles when the forming groove of the middle mold is a semi-cone;

[0046] Figure 4 for Figure 3 Enlarged diagram of point A in the diagram;

[0047] Figure 5 for Figure 3 A sectional view of the middle mold;

[0048] Figure 6 A schematic diagram of a microneedle in the shape of a semi-cone;

[0049] Figure 7 for Figure 6 The main view;

[0050] Figure 8 for Figure 6 Side view;

[0051] Figure 9 for Figure 2 Exploded view of the mold and planar microneedles when the forming groove of the middle mold is a triangular pyramid;

[0052] Figure 10 for Figure 9 A sectional view of the middle mold;

[0053] Figure 11 A schematic diagram of a microneedle shaped like a triangular pyramid;

[0054] Figure 12 for Figure 2 When the forming groove of the middle mold is a half-gourd body, the exploded view of the mold and the planar micro needle;

[0055] Figure 13 for Figure 12 Another perspective illustration;

[0056] Figure 14 for Figure 12 A sectional view of the middle mold;

[0057] Figure 15 A schematic diagram of the microneedles in a half-gourd body;

[0058] Figure 16 for Figure 2 An exploded view of the mold and the planar micro needle when the forming groove of the middle mold is a semi-conical shape and has a protrusion.

[0059] Figure 17 for Figure 16 Enlarged view of point B;

[0060] Figure 18 for Figure 16 Another perspective illustration;

[0061] Figure 19 for Figure 16A sectional view of the middle mold;

[0062] Figure 20A A schematic diagram of a microneedle with a protruding triangular pyramid shape;

[0063] Figure 20B This is the front view of Figure 20;

[0064] Figure 21 for Figure 2 An exploded view of the mold and the planar micro needle when the forming groove of the middle mold is a semi-conical shape and is provided with a protrusion and an easy-tear forming part;

[0065] Figure 22 for Figure 21 Enlarged diagram of point C in the diagram;

[0066] Figure 23 for Figure 21 Another perspective illustration;

[0067] Figure 24 The main view of the planar microneedle vertical device of Embodiment 5 of the present invention uses a vacuum negative pressure adsorption adhesive as the microneedle flipping component;

[0068] Figure 25 for Figure 24 Enlarged view of point D in the image;

[0069] Figure 26 for Figure 24 A three-dimensional schematic diagram;

[0070] Figure 27 The front view of the planar microneedle vertical device of Embodiment 5 of the present invention uses a wind pressure adhesive as the microneedle flipping component;

[0071] Figure 28 for Figure 27 Enlarged view of point E in the image;

[0072] Figure 29 for Figure 27 A three-dimensional schematic diagram;

[0073] Figure 30 The main view of the planar microneedle vertical device of Embodiment 5 of the present invention uses a roller contact pressing component as the microneedle flipping component;

[0074] Figure 31 for Figure 30 Enlarged view of point F in the image;

[0075] Figure 32 for Figure 30 A three-dimensional schematic diagram.

[0076] [Explanation of Labels in the Attached Image]

[0077] 1: First conveyor belt; 11: First slot; 12: Second slot;

[0078] 2: Second conveyor belt;

[0079] 31: Vacuum negative pressure adsorption bonding component; 32: Air pressure bonding component; 33: Roller contact pressing component; 331: Roller; 332: Support frame;

[0080] 4: Storage tank;

[0081] 5: Negative pressure adsorber;

[0082] 6: Adhesive layer;

[0083] 7: Planar microneedle; 71: Base layer; 711: Gap; 712: Base through-hole; 72: Microneedle; 721: Needle tip; 722: Middle part; 723: Needle seat; 724: First surface; 725: Second surface; 726: Third surface; 727: Protrusion; 728: Tear-off opening;

[0084] 8: Microneedle patches;

[0085] 110: Base; 111: Receiving groove; 112: Positioning post;

[0086] 120: Mold; 121: Forming groove; 1211: Needle tip groove; 1212: Middle groove; 1213: Needle seat groove; 1214: Side wall; 1215: Bottom wall; 122: Isolation part; 123: Protrusion part; 124: Easy-tear forming part;

[0087] 130: Panel; 131: Molding hole; 132: Positioning hole;

[0088] L1: Dimension of the third surface of the microneedle;

[0089] L2: The size of the third surface projection of the microneedle onto the adhesive layer. Detailed Implementation

[0090] To better explain and facilitate understanding of the present invention, a detailed description of the invention is provided below with reference to the accompanying drawings and specific embodiments. In this document, directional terms such as "upper" and "lower" are used interchangeably with other directional terms. Figure 2 The orientation is used as a reference.

[0091] Example 1

[0092] See Figure 1-32As shown, this embodiment of the invention provides a planar microneedle, including a base layer 71 and microneedles 72 disposed on the base layer 71. The microneedle 72 includes a needle tip 721, a needle seat 723, and a middle portion 722 connecting the needle tip 721 and the needle seat 723. The direction of the needle tip 721 toward the needle seat 723 is the same as the extending direction of the base layer 71. The microneedle 72 is formed by a molding groove 121 in a mold 120. The direction of the needle tip groove 1211 for forming the needle tip 721 toward the needle seat groove 1213 for forming the needle seat 723 is horizontal, thereby reducing the depth of the molding groove 121 and reducing the ratio of the maximum depth to the maximum length of the molding groove 121, facilitating precise injection of drug-loaded liquid into the needle tip groove 1211 of the molding groove 121. Because the molding groove 121 of the microneedle 72 is horizontally oriented, the drug-loaded liquid can be poured directly into the needle tip groove 1211 without passing through the middle groove 1212 and the needle seat groove 1213. This avoids splashing or flowing through the middle groove 1212 and the needle seat groove 1213, ensuring that the drug-loaded liquid is loaded only at the needle tip 721, thus precisely controlling the dosage of the microneedle patch 8 during use. Furthermore, reducing the ratio of the maximum depth to the maximum length of the molding groove 121 also reduces the demolding resistance between the microneedle 72 and the molding groove 121 after molding, preventing the microneedle 72 from breaking, improving the yield of the microneedle 72, and reducing costs. On the other hand, since the molding groove 121 is set horizontally, the needle tip groove 1211 can be set to be larger than the middle groove 1212 or the needle seat groove 1213 in the horizontal direction, so that the microneedle 72 forms an arrow shape and other structures to prevent it from detaching from the skin, and the microneedle 72 is easy to demold during the production and preparation process.

[0093] See Figure 6 , 7 As shown in 10, 11, 14, 15, 19 and 20A, specifically, the microneedle 72 includes a first surface 724, a second surface 725 and a third surface 726.

[0094] The first surface 724 is planar and lies on the same plane as the base layer 71. A gap 711 exists between the connection between the first surface 724 and the second surface 725 and the base layer 71. The third surface 726 is connected to the base layer 71, allowing the microneedle 72 to rotate around the connection between the third surface 726 and the base layer 71 and pass through the gap 711, thus flipping from the first surface 724 and the base layer 71 lying on the same plane to the third surface 726 and the base layer 71 lying on the same plane. The microneedle patch 8 has an adhesive layer 6 protruding from the base layer 71 near the needle seat 723. The microneedle 72 rotates around the connection between the third surface 726 and the base layer 71, causing the third surface 726 of the microneedle 72 to adhere to the adhesive layer 6, completing the vertical shape of the microneedle 72. The straight line connecting the needle tip 721 and the needle seat 723 forms a certain angle with the base layer 71, thus forming the microneedle patch 8. Preferably, the straight line connecting the needle tip 721 and the needle base 723 is perpendicular to the base layer 71. When using the microneedle patch 8, the direction of the external force pressing the microneedle patch 8 coincides with the direction of the needle tip 721 pointing to the needle base 723. Under the action of a small force, the microneedle 72 can be smoothly inserted into the skin, and the lateral shear force on the microneedle 72 is almost 0, which can effectively prevent the microneedle 72 from breaking during use.

[0095] Furthermore, the ratio of the maximum depth of the microneedle 72 in the direction perpendicular to the substrate layer 71 to the maximum length in the direction of the substrate layer 71 is 1:(2-5). Correspondingly, the ratio of the maximum depth to the maximum length of the forming groove 121 used to form the microneedle 72 is 1:(2-5). When the ratio of the maximum depth to the maximum length of the microneedle 72 is greater than 5, the microneedle 72 is too sharp and is prone to breakage when inserted.

[0096] See Figure 8 Furthermore, the included angle β between the first surface 724 and the third surface 726 is 45°-90°. This angle affects the ease of demolding after the microneedle 72 is formed and the performance of the microneedle patch 8. When β is greater than 90°, demolding after the microneedle 72 is formed cannot be completed. When β is less than 45°, the included angle between the first surface 724 and the third surface 726 of the microneedle 72 in the prepared microneedle patch 8 is small. When the microneedle 72 is upright, the included angle between the first surface 724 of the microneedle 72 and the base layer 71 is small, resulting in a small tilt angle between the direction of the microneedle tip 721 pointing to the needle seat 723 and the base layer 71. During use, the microneedle 72 cannot penetrate the skin or the resistance to penetration is too great, causing the microneedle 72 to break, thus making it impossible to use the microneedle patch 8 normally.

[0097] The angle α between the second surface 725 and the third surface 726 is 60°-90°, which affects the volume and shape of the formed microneedles 72. When α is less than 60°, the width of the microneedle 72 needle seat 723 is large. When using the microneedle patch 8, the needle seat 723 may remain in the stratum corneum or fail to penetrate the target layer of the skin due to its large width, affecting the drug delivery stability after the microneedles 72 penetrate the skin and causing waste of molding material at the needle seat 723. When α is greater than 90°, the angle between the second surface 725 and the third surface 726 of the microneedles 72 in the prepared microneedle patch 8 is large, reducing the height of the microneedles 72 after shaping. Moreover, the tilt angle of the microneedles 72 relative to the base layer 71 after shaping is large. During use, the angle between the direction of external force and the direction of the microneedle tip 721 pointing to the needle seat 723 is large, causing the microneedles 72 to fail to penetrate the skin or the resistance to penetration is too great, leading to breakage of the microneedles 72, and thus the microneedle patch 8 cannot be used normally.

[0098] The angle θ between the first surface 724 and the second surface 725 is 15°-45°. This angle affects the sharpness of the needle tip 721 of the microneedle 72. When θ is less than 15°, the needle tip 721 of the microneedle 72 is relatively sharp. When using the microneedle patch 8, the needle tip 721 of the microneedle 72 is prone to breakage due to its low strength when it penetrates the skin, resulting in inaccurate drug delivery and thus preventing the normal use of the microneedle patch 8. When θ is greater than 45°, the needle tip 721 of the microneedle 72 is relatively blunt. When using the microneedle patch 8, the needle tip 721 of the microneedle 72 faces greater resistance when penetrating the skin, causing intense pain or even preventing penetration, which also prevents the normal use of the microneedle patch 8.

[0099] See Figures 20A-20B Furthermore, the second surface 725 of the microneedle 72 extends outward along the width direction of the microneedle 72 to form a protrusion 727. When the microneedle patch 8 is used, after the microneedle 72 is inserted into the skin, the protrusion 727 on the microneedle 72 can increase the gripping force between the microneedle 72 and the skin, preventing the microneedle 72 from being squeezed out of the skin under the action of skin rebound force after being inserted into the skin, or from being taken out when the base layer 71 and adhesive layer 6 are torn off after the microneedle 72 is inserted into the skin, thus preventing the microneedle 72 from achieving precise drug delivery.

[0100] Preferably, protrusions 727 are provided on both sides of the second surface 725 of the microneedle 72, and the protrusions 727 on both sides of the second surface 725 are staggered. Compared with the protrusions 727 symmetrically arranged on both sides of the second surface 725, the staggered protrusions 727 on both sides of the second surface 725 can reduce the cross-sectional area of ​​the microneedle 72, thereby reducing the resistance when the microneedle 72 penetrates the skin, thus reducing skin damage and reducing pain.

[0101] See Figure 21Furthermore, an easy-tear opening 728 is provided at the connection between the third surface 726 of the microneedle 72 with protrusion 727 and the base layer 71. The easy-tear opening 728 is a notch formed at the connection between the third surface 726 and the base layer 71. When using the microneedle patch 8, after the microneedle 72 is inserted into the skin, the base layer 71 can be easily torn off by applying force through the easy-tear opening 728. Moreover, because the microneedle 72 has protrusion 727, the gripping force between the microneedle 72 and the skin is large, and the microneedle 72 can be stably embedded in the skin, realizing the rapid separation of the base layer 71 and the microneedle 72. This avoids discomfort caused by the base layer 71 adhering to the skin for a long time when using the microneedle patch 8. It is especially suitable for children, pets or mental patients, and can prevent users from scratching or licking the base layer 71, which would cause the microneedle patch 8 to fall off.

[0102] See Figures 6-21 Furthermore, the microneedle 72 is a semi-cone, a triangular pyramid, a semi-gourd, or a combination of a semi-cone and a semi-frustum arranged vertically.

[0103] When the microneedle 72 is a triangular pyramid, it includes two second faces 725. When the microneedle 72 is a combination of a semi-cone and a frustum arranged vertically, the semi-cone protrudes from the frustum to form a protrusion 727 on the microneedle 72, which also improves the gripping force between the microneedle 72 and the skin. Moreover, the semi-cone part of the microneedle 72 has a larger volume than the protrusion 727. After the microneedle 72 is inserted into the skin, the skin is compressed by the microneedle 72 and then recovers its shape. The semi-cone part is more stably embedded in the skin, and the microneedle 72 has a greater gripping force on the skin.

[0104] Example 2

[0105] Based on Example 1, this example provides a microneedle patch 8.

[0106] See Figure 1-32 The microneedle patch 8 includes an adhesive layer 6. The working principle of transforming the planar microneedle 7 into the microneedle patch 8 is as follows: the adhesive layer 6 adheres to the base layer 71 and protrudes from the base layer 71 near the microneedle 72. There is a gap 711 between the connection between the first surface 724 and the second surface 725 and the base layer 71. The microneedle 72 rotates around the connection between the third surface 726 and the base layer 71 until the third surface 726 and the base layer 71 are on the same plane. The microneedle 72 is vertical, and the third surface 726 is adhered to the adhesive layer 6. The microneedle 72, the base layer 71, and the adhesive layer 6 are arranged and combined from top to bottom to form the microneedle patch 8. At this time, the direction of the needle tip 721 of the microneedle 72 toward the needle seat 723 forms a certain angle with the base layer 71.

[0107] See Figure 32As shown, since the area and size of the first surface 724 of the microneedle 72 are larger than the area and size of the third surface 726, the first surface 724 of the microneedle 72 in the planar microneedle 7 is located on the same plane as the substrate layer 71. However, when it transforms into the microneedle patch 8, the microneedle 72 flips so that the third surface 726 is located on the same plane as the substrate layer 71. At this time, the difference in area and size between the first surface 724 and the third surface 726 forms a substrate through-hole 712, and this substrate through-hole 712 is located at the junction of the substrate layer 71 and the microneedle 72. The adhesive layer 6 is exposed inside the substrate through-hole 712.

[0108] When using the microneedle patch 8, after the microneedle 72 is inserted into the skin, the adhesive layer 6 in the base through-hole 712 can adhere to the skin. Compared with the traditional microneedle patch 8, where only the outer periphery of the base layer 71 is adhered to the skin, each base through-hole 712 has an adhesive layer 6 that can adhere to the skin, thereby improving the adhesion between the microneedle patch 8 and the skin. This prevents the rebound force of the skin from squeezing the microneedle 72 out of the skin after it is inserted. Moreover, because the adhesive force of the adhesive layer 6 is smaller in the middle part of the base layer 71, the base layer 71 may bulge out of the skin, affecting the drug delivery effectiveness of the microneedle 72 located in the middle of the base layer 71.

[0109] Example 3

[0110] See Figure 1-23 As shown, based on Embodiment 1 and Embodiment 2, this embodiment of the invention provides a manufacturing device for planar microneedles.

[0111] The fabrication equipment for planar microneedles includes a base 110, a mold 120, and a panel 130 located above the base 110. The top of the base 110 has a receiving groove 111 for accommodating the mold 120. The top of the mold 120 has multiple forming grooves 121 for forming microneedles 72. Each forming groove 121 includes a tip groove 1211, a base groove 1213, and a central groove 1212 connecting the tip groove 1211 and the base groove 1213. The tip groove 1211 faces horizontally towards the base groove 1213. The tip groove 1211 is used to form the tip 721 of the microneedle 72, the central groove 1212 is used to form the center 722 of the microneedle 72, and the base groove 1213 is used to form the base 723 of the microneedle 72. The tip 721, center 722, and base 723 combine to form the microneedle 72. The panel 130 is provided with a plurality of molding grooves 121 for accommodating the mold 120 and molding holes 131 for molding the base layer 71.

[0112] In the aforementioned planar microneedle manufacturing equipment, the direction of the needle tip groove 121 towards the needle seat groove 1213 in the forming groove 121 of the forming microneedle 72 is horizontal, so as to reduce the depth of the forming groove 121 and the ratio of the maximum depth to the maximum length of the forming groove 121. This facilitates the precise injection of drug-loaded liquid into the needle tip groove 1211 of the forming groove 121, and avoids splashing of drug-loaded liquid to contaminate the middle groove 1212 and the needle seat groove 1213. As a result, the formed microneedle 72 is loaded with drug only at the needle tip 721, so as to precisely control the amount of drug administered when the microneedle patch 8 is used.

[0113] Specifically, in existing manufacturing equipment, microneedle patches 8 extending perpendicularly to the substrate layer 71 are directly formed from microneedles 72. The ratio of the maximum depth to the maximum length of the forming groove 121 in the mold 120 used to form the microneedles 72 is 2-5. In this application, the ratio of the maximum depth to the maximum length of the forming groove 121 in the mold 120 is 1:(2-5). Compared to the prior art, the forming groove 121 in this application significantly reduces its depth and the ratio of its maximum depth to maximum length. This reduces the difficulty of filling the microneedles 72, eliminating the need for other processes such as vacuum adsorption, centrifugation, or high-pressure jetting to fill the forming groove 121 with the raw material liquid, thus shortening the preparation process and reducing costs. Furthermore, it reduces the demolding resistance between the microneedles 72 and the forming groove 121 after forming, preventing breakage of the microneedles 72, improving the yield of the microneedles 72, and reducing costs. Meanwhile, since the molding groove 121 is set in a horizontal direction, the demolding of the needle tip 721 and / or the middle part 722 of the microneedle 72 is not affected by the shape of the middle part 722 and / or the needle seat 723. The microneedle 72 can be designed such that the volume of the needle tip 721 is larger than the shape of the middle part 722 or the needle seat 723 of the microneedle 72, thereby enhancing the embedding stability of the microneedle 72 after it is inserted into the skin, ensuring that the drug-loaded components in the microneedle 72 dissolve in the skin, and achieving precise drug delivery.

[0114] Furthermore, the molding groove 121 is a semi-cone, a triangular pyramid, a semi-gourd, or a combination of semi-cones and semi-frustums arranged vertically, to correspond with the microneedles 72 which are molded as semi-cones, triangular pyramids, semi-gourds, or a combination of semi-cones and semi-frustums arranged vertically, to meet different drug loading and usage requirements, while realizing the stable embedding of the microneedles 72 in the skin and achieving precise drug delivery.

[0115] Furthermore, the forming groove 121 includes a bottom wall 1215 and a side wall 1214.

[0116] See Figure 5As shown, the angle β between the bottom wall 1215 of the forming groove 121 and the top of the mold 120 is 45°-90°, which is used to make the angle β between the first surface 724 and the third surface 726 of the formed microneedle 72 45°-90°. The angle α between the bottom wall 1215 of the forming groove 121 and the side wall 1214 of the forming groove 121 is 60°-90°, which is used to make the angle α between the second surface 725 and the third surface 726 of the formed microneedle 72 60°-90°. The angle θ between the bottom wall 1215 of the forming groove 121 and the top of the mold 120 is 15°-45°, which is used to make the angle θ between the first surface 724 and the second surface 725 of the formed microneedle 72 15°-45°.

[0117] See Figure 3-21 As shown, further, the top of the mold 120 protrudes upward to form an isolation portion 122, which is circumferentially arranged around the side wall 1214 of the molding groove 121. When the mold 120 is fitted into the receiving groove 111 of the base 110, and the panel 130 is installed on the top of the base 110 and the mold 120, the height of the partition portion is at least the same as the height of the panel 130. When preparing the planar microneedles 7, after assembling the base 110, the mold 120 and the panel 130, the raw material liquid is injected into the molding hole 131 of the panel 130, and the raw material liquid enters the molding groove 121 of the mold 120. The raw material liquid in the molding hole 131 is formed into a base layer 71, and the raw material liquid in the molding groove 121 is formed into microneedles 72. The isolation portion 122 located at the top of the mold 120 blocks the raw material liquid, so that the molded base layer 71 forms a notch at the position corresponding to the isolation portion 122, so that a gap 711 is formed between the molded base layer 71 and the first surface 724 of the microneedle 72 in the circumferential direction. There is a gap 71 between the connection between the first surface 724 and the second surface 725 and the base layer 71. Then, when the planar microneedle 7 is transformed into the microneedle patch 8, the microneedle 72 can rotate around the connection between the third surface 726 and the base layer 71 and pass through the gap 711 between the first surface 724 in the circumferential direction and the base layer 71, until the third surface 726 and the base layer 71 are on the same plane and adhere to the adhesive layer 6, thus completing the vertical shape of the microneedle 72 and forming the microneedle patch 8.

[0118] See Figure 16-17 As shown, preferably, the isolation portion 122 extends outward along the width direction of the molding groove 121 to form a protrusion 123, which is used to form the protrusion 727 on the microneedle 72.

[0119] Specifically, protrusions 123 are provided on both sides of the isolation portion 122, and the protrusions 123 on both sides of the isolation portion 122 are staggered to form protrusions 727 staggered on both sides of the micro needle 72.

[0120] See Figure 21-22As shown, more preferably, based on the mold 120 with the protrusion 123, the isolation portion 122 of the forming groove 121 extends towards the third surface 726 to form an easy-tear forming portion 124. The width of the easy-tear forming portion 124 is smaller than the width of the side wall 1214, and the easy-tear forming portion 124 is connected to the isolation portion 122. The easy-tear forming portion 124 is used to form the easy-tear opening 728 of the microneedle 72.

[0121] See Figure 1 and Figure 2 As shown, preferably, to facilitate the assembly of the panel 130 and the base 110, a positioning post 112 is provided on the top of the base 110, and a positioning hole 132 is provided on the bottom of the panel 130. The positioning hole 132 and the positioning post 112 are arranged opposite to each other. In use, the positioning post 112 of the base 110 is inserted into the positioning hole 132 of the panel 130, which can conveniently and quickly achieve precise positioning of the panel 130 and the base 110.

[0122] Example 4

[0123] See Figure 1 and Figure 2 As shown, this embodiment, based on embodiments 1-3, also provides a method for preparing planar microneedles. Specifically, it includes the following steps:

[0124] A1: Prepare raw material solutions, including drug-loaded raw material solutions and base raw material solutions.

[0125] A2: Assemble the base 110, mold 120 and panel 130: Place the mold 120 in the receiving groove 111 of the base 110, and the positioning hole 132 of the panel 130 is embedded in the positioning post 112 of the base 110. The forming hole 131 of the panel 130 is located above the mold 120 and accommodates multiple forming grooves 121 of the mold 120.

[0126] A3: Fill the needle tip groove 1211 of the mold 120 with drug-loaded raw material liquid, or inject the drug-loaded raw material liquid by high pressure injection, vacuum suction or centrifugation, and dry it into the needle tip 721 of the microneedle 72.

[0127] A4: Fill the molding holes 131 of panel 130 with base material liquid. The base material liquid can be injected by high pressure injection, vacuum suction or centrifugation until it fills the molding holes 131 and panel 130, and then the material liquid is scraped flat along the top of panel 130.

[0128] The raw material liquid is dried: the raw material liquid in the forming hole 131 is dried to form the base layer 71, the raw material liquid in the needle seat groove 1213 is dried to form the needle seat 723 of the microneedle 72, and the raw material liquid in the middle groove 1212 is dried to form the middle part 722 of the microneedle 72. The isolation part 122 located at the top of the mold 120 blocks the raw material liquid, and the formed base layer 71 has a notch at the position corresponding to the isolation part 122, so that there is a gap 711 between the connection between the first surface 724 and the second surface 725 and the base layer 71.

[0129] A5: Remove panel 130 and separate microneedles 72 from molding groove 121.

[0130] The above preparation method is simple to operate and highly efficient.

[0131] Specifically, step A1 also includes:

[0132] When the drug is water-soluble: the drug-loaded solution includes sodium hyaluronate solution, the active ingredient, and water. The sodium hyaluronate solution contains 5%–50% sodium hyaluronate solution with a molecular weight of 30,000–300,000, and 1%–20% sodium hyaluronate solution with a molecular weight less than or equal to 10,000. The active ingredient accounts for 1%–20% of the drug-loaded solution. Water accounts for 50%–80% of the drug-loaded solution. The solid content of this drug-loaded solution is 20%–60%.

[0133] When the drug is oil-soluble: the drug-loaded raw material solution includes a sodium hyaluronate solution and an oil-soluble active ingredient solution. The density of the oil-soluble active ingredient solution is greater than 1 and similar to that of the sodium hyaluronate solution. Because the densities of the oil-soluble active ingredient solution and the sodium hyaluronate solution are similar, the oil-soluble active ingredient can be stably suspended in the sodium hyaluronate solution and will not sink or float during the drying process of the drug-loaded solution, ensuring that the oil-soluble active ingredient is stably distributed in the sodium hyaluronate after the drug-loaded solution has dried.

[0134] When microneedles 72 are insoluble in water and human tissue fluid for use in tissue fluid extraction and detection: the drug-loaded raw material solution includes a component solution and a 2% calcium chloride ethanol solution. The component solution comprises 15% sodium alginate, 10% polyvinyl alcohol, and 75% water. Before use, the three components in the component solution are mixed thoroughly and then heated to dissolve at 60–65°C, followed by heat treatment to remove bubbles. The 2% calcium chloride ethanol solution comprises 2% calcium chloride and 98% anhydrous ethanol. Before use, the two components in the 2% calcium chloride ethanol solution are stirred and dissolved. After the planar microneedles 7 are formed, they are immersed in the 2% calcium chloride ethanol solution for 1–2 minutes to allow a chemical reaction between sodium alginate and calcium chloride to produce sodium calcium alginate. Sodium calcium alginate is insoluble in water and human tissue fluid and can be used for tissue fluid extraction and detection. Subsequently, it is dried in a 35°C forced-air drying oven for 20–30 minutes.

[0135] Specifically, step A4 also includes:

[0136] After injecting the raw material liquid into the forming hole 131 of the panel 130, the drug-loaded liquid is scraped and leveled along the direction from the needle tip groove 1211 of the mold 120 toward the needle seat groove 1213. Since the depth of the needle tip groove 1211 gradually increases in the direction from the needle seat groove 1213, when the drug-loaded liquid is leveled along this direction, as the raw material liquid fills the forming groove 121, the gas in the forming groove 121 is discharged along the direction from the needle tip groove 1211 toward the needle seat groove 1213, avoiding the presence of air bubbles in the formed microneedles 72, and ensuring that the drug loading of the microneedles 72 is accurate and the strength meets the requirements.

[0137] Alternatively, raw material liquid can be injected into the forming holes 131 of panel 130 until they are completely filled. After smoothing the raw material liquid along the top of panel 130, it is placed in a vacuum chamber and vacuumed at -0.2 MPa for 2 minutes to remove gas from the raw material liquid in the forming tank 121, thus preventing air bubbles from forming in the microneedles 72. This vacuuming process requires less power and takes less time, saving energy and shortening the forming time of microneedles 72, thereby improving production efficiency.

[0138] Alternatively, raw material liquid can be injected into the forming holes 131 of panel 130 until they are completely filled. After smoothing the raw material liquid along the top of panel 130, it can be placed in a centrifuge and centrifuged at 200 r / min for 1 min, followed by centrifugation at 1000 r / min for 3 min to remove gas from the raw material liquid in forming tank 121 and prevent air bubbles from forming in the microneedles 72. This centrifugation process requires less power and takes less time, saving energy and shortening the forming time of microneedles 72, thus improving production efficiency.

[0139] Specifically, step A4 also includes:

[0140] During the drying process:

[0141] After injecting the raw material liquid into the molding hole 131 of the panel 130, it is dried for 20-30 minutes in an environment with a relative humidity of 25%-30% to achieve the first stage of rapid drying. Then, it is dried for 10-30 minutes in an environment with a relative humidity of 40%-60% to achieve the second stage of slow drying. The drying method combining rapid and slow drying can prevent the planar microneedles 7 from curling or deforming during the drying process, thereby ensuring the finished product quality of the planar microneedles 7, shortening the drying time of the planar microneedles 7, shortening the production cycle of the planar microneedles 7, improving the production efficiency of the planar microneedles 7, and reducing the production cost.

[0142] Alternatively, after injecting the raw material liquid into the molding hole 131 of the panel 130, it can be slowly dried overnight in a drying oven with a relative humidity of 25%-60% to ensure that the planar microneedles 7 do not curl or deform during the drying process, thereby ensuring the finished product quality of the planar microneedles 7.

[0143] Specifically, step A5 also includes:

[0144] After the raw material liquid is dried, the panel 130 is removed, and an upward suction force is applied to the base layer 71 by vacuum adsorption to quickly separate the base layer 71 from the mold 120, thereby separating the microneedle 72 from the molding groove 121 of the mold 120 and forming it into a planar microneedle 7.

[0145] Alternatively, after the raw material solution dries, the panel 130 is removed, and the base layer 71 is peeled off along the needle seat 723 of the microneedle 72 towards the needle tip 721 to separate the microneedle 72 from the molding groove 121 and form a microneedle patch 8. During this process, peeling off the base layer 71 along the needle seat 723 of the microneedle 72 towards the needle tip 721 means that force is applied at the connection between the first surface 724 and the third surface 726 of the microneedle 72 and the base layer 71 to separate the microneedle 72 from the molding groove 121. This avoids the connection between the first surface 724 and the third surface 726 of the microneedle 72 and the base layer 71 from breaking, which would lead to the separation of the microneedle 72 and the base layer 71 and result in defective products. This improves the yield of the planar microneedle 7 and reduces the production cost of the planar microneedle 7.

[0146] Example 5

[0147] See Figures 24-32 As shown, this embodiment, based on Embodiment 1, further provides a planar microneedle vertical forming device for adhering planar microneedles 7 to an adhesive layer 6 to form a microneedle patch 8. The planar microneedle 7 includes a base layer 71 and a plurality of microneedles 72 rotatably disposed on the base layer 71, with the microneedles 72 arranged in multiple rows and columns on the base layer 71. The first surface 724 of the microneedles 72 is located on the same plane as the base layer 71.

[0148] The planar microneedle vertical device includes a conveyor belt assembly and a microneedle flipping component.

[0149] The conveyor belt assembly is used to transport the planar microneedles 7 and the adhesive layer 6. A microneedle flipper is located at the junction of the planar microneedles 7 and the adhesive layer 6. The microneedle flipper is used to adhere the base layer 71 to the adhesive layer 6 and to flip the microneedles 72 from a first side 724 parallel to the base layer 71 to a third side 726 parallel to the base layer 71, and to adhere the third side 726 to the adhesive layer 6, thus completing the microneedle upright shape.

[0150] The conveyor belt assembly includes a first conveyor belt 1 and a second conveyor belt 2. The first conveyor belt 1 is inclined and used to convey planar microneedles 7. The second conveyor belt 2 is horizontally positioned below the first conveyor belt 1 and is used to convey an adhesive layer 6 and receive the planar microneedles 7 from the first conveyor belt 1. A microneedle flipper is located near the lower end of the first conveyor belt 1.

[0151] During the shaping process, the inclined first conveyor belt 1 can gradually convey the planar microneedles 7 to the adhesive layer 6 on the second conveyor belt 2, ensuring that the planar microneedles 7 and the adhesive layer 6 are flatly bonded without air bubbles or wrinkles. The microneedle flipping component is used to adhere the base layer 71 of the planar microneedle 7 to the adhesive layer 6, and to rotate the microneedles 72 of the planar microneedle 7 around the connection between the third surface 726 and the base layer 71. The microneedles 72 rotate from being in the same plane as the first surface 724 of the microneedle 72 and the base layer 71 to being in the same plane as the third surface 726 of the microneedle 72, thus shaping the microneedles 72. Subsequently, the bottom of the microneedles 72 adheres to the adhesive layer 6, and the planar microneedles 7 and the adhesive layer 6 are combined to form a microneedle patch 8.

[0152] In summary, this planar microneedle vertical forming device is suitable for two-step forming of microneedle patch 8. First, the planar microneedle 7 is formed by microneedle mold 120, and then the planar microneedle vertical forming device adheres the planar microneedle 7 to the adhesive layer 6. The microneedle 72 is adjusted so that the third surface 726 is on the same plane as the base layer 71 and then adheres to the adhesive layer 6.

[0153] Furthermore, the microneedle flipping component applies a force to the planar microneedles 7 to adhere them to the adhesive layer 6. The direction of this force is preferably perpendicular to the conveying direction of the second conveyor belt 2. During operation, the force applied by the microneedle flipping component to the planar microneedles 7 acts row by row / step by step on the planar microneedles 7, causing the base layer 71 of the planar microneedles 7 to adhere row by row to the adhesive layer 6. During this gradual / row-by-row adhesion, the microneedles 72 on the planar microneedles 7 experience a reaction force from the adhesive layer 6. Under this reaction force, each row of microneedles 72 can simultaneously rotate around the connection point between their respective third surface 726 and the base layer 71, causing the microneedles 72 to rotate from being in the same plane as the first surface 724 and the base layer 71 to being in the same plane as the third surface 726, thus completing the microneedle upright shape. Subsequently, the third surface 726 of the microneedles 72 adheres to the adhesive layer 6, achieving the bonding of the planar microneedles 7 and the adhesive layer 6 into a microneedle patch 8. During this process, the base layer 71 and the adhesive layer 6 make contact row by row to gradually achieve the bonding between the base layer 71 and the adhesive layer 6. This can completely expel the air between the base layer 71 and the adhesive layer 6. Since the first conveyor belt 1 and the second conveyor belt 2 have a certain angle, the size of the third surface 726 of the microneedle 72 is similar to its size projected onto the adhesive layer 6. Furthermore, the third surface 726 of the microneedle 72 is bonded to the adhesive layer 6 layer by layer. The difference between the size L1 of the third surface 726 of the microneedle 72 and its projected size L2 on the adhesive layer 6 is small. Moreover, both the base layer 71 and the adhesive layer 6 have a certain degree of elasticity. Therefore, it can avoid the accumulation of the size difference allowance when all the third surfaces 726 of the microneedle 72 are bonded to the adhesive layer 6 at the same time during the vertical forming process, which would lead to wrinkling of the microneedle patch 8 after molding. Meanwhile, after the microneedle 72 rotates to the third surface 726 and adheres to the adhesive layer 6, the adhesive layer 6 at the contact point with the third surface 726 of the microneedle 72 can be made smooth and wrinkle-free under the traction of the adhesive force between the base layer 71 and the adhesive layer 6, thereby improving the yield of the molded microneedle patch 8.

[0154] Furthermore, at least one microneedle flipper is provided at intervals along the conveying direction of the second conveyor belt 2, so that after the microneedle flipper near the first conveyor belt 1 adheres the planar microneedle 7 to the adhesive layer 6, the remaining microneedle flippers can continuously apply force to the microneedle patch 8 to make the bond between the planar microneedle 7 and the adhesive layer 6 more solid.

[0155] Furthermore, the microneedle flipping component can be of the following types:

[0156] Reference Figures 24-26 As shown, the microneedle flipping component can be a vacuum negative pressure adsorption adhesive component 31. The vacuum negative pressure adsorption adhesive component 31 is disposed below the second conveyor belt 2. The vacuum negative pressure adsorption adhesive component 31 is used to apply a negative pressure airflow perpendicular to the conveying direction of the second conveyor belt 2 to the planar microneedles 7. Under the adsorption force of the negative pressure airflow, the planar microneedles 7 adhere to the adhesive layer 6 to form a microneedle patch 8.

[0157] At this time, both the second conveyor belt 2 and the adhesive layer 6 are provided with grid-like through holes for airflow.

[0158] Reference Figures 27-29 As shown, the microneedle flipping component can be a pneumatic adhesive component 32. The pneumatic adhesive component 32 is disposed above the second conveyor belt 2. The pneumatic adhesive component 32 can apply an airflow perpendicular to the conveying direction of the second conveyor belt 2 to the planar microneedles 7. Under the adhesive pressure of this airflow, the planar microneedles 7 adhere to the adhesive layer 6 to form a microneedle patch 8.

[0159] At this time, the second conveyor belt 2 can be a mesh plane or a non-porous plane, and the adhesive layer 6 is a non-porous plane.

[0160] Reference Figures 30-32 As shown, the microneedle flipping component can be a roller contact pressing component 33. The roller contact pressing component 33 includes at least one spaced roller 331, the axis of which is perpendicular to the conveying direction of the second conveyor belt 2. Each roller 331 is used to roll on the base layer 71 between two adjacent microneedles 72 in each row of the planar microneedles 7, gradually / row-by-row applying pressure to the base layer 71, and causing the adhesive layer 6 to form a reaction force for gradually / row-by-row applying pressure to the microneedles 72, thereby causing the planar microneedles 7 to adhere to the adhesive layer 6 to form a microneedle patch 8. Because the pressing area between the roller 331 and the planar microneedles 7 is small, the pressure is relatively high, enabling a stronger adhesion between the base layer 71 and the bottom of the microneedles 72 and the adhesive layer 6.

[0161] The roller contact pressing component 33 also includes a support frame 332, on which the roller 331 is rotatably mounted.

[0162] Preferably, the angle between the extending direction of the first conveyor belt 1 and the extending direction of the second conveyor belt 2 is 135°-179°.

[0163] When the angle between the extension direction of the first conveyor belt 1 and the extension direction of the second conveyor belt 2 is less than 135°, it is easy for the angle between the planar microneedle 7 and the adhesive layer 6 to be too large when the planar microneedle 7 adheres to the adhesive layer 6. This causes the force exerted on the planar microneedle 7 by the airflow applied by the vacuum negative pressure adsorption adhesive 31 and the wind pressure adhesive 32 to be decomposed into an increased horizontal component parallel to the adhesive layer 6 and a decreased vertical component perpendicular to the adhesive layer 6. This results in: the base layer 71 of the planar microneedle 7 cannot be pressed onto the surface of the adhesive layer 6, the base layer 71 and the adhesive layer 6 cannot adhere, or the adhesion between the base layer 71 and the adhesive layer 6 is insufficient, and the base layer 71 and the adhesive layer 6 cannot achieve complete adhesion. Due to the insufficient vertical component of force acting on the planar microneedle 7, the base layer 71 and the adhesive layer 6 cannot adhere or adhere completely, and the adhesive layer 6 generates a small reaction force for rotating the microneedle 72, making the microneedle 72 unable to rotate or unable to rotate completely. When the roller contacts the pressing part 33 to press the vertical shape, the roller 331 comes into contact with the planar micro needle 7 that has not been conveyed to the second conveyor belt 2 and damages the micro needle 72.

[0164] When the angle between the extension direction of the first conveyor belt 1 and the extension direction of the second conveyor belt 2 is greater than 179°, since the first conveyor belt 1 and the second conveyor belt 2 are almost parallel, when the microneedles 72 are upright, the bottom of all the microneedles 72 are simultaneously bonded to the adhesive layer 6. The cumulative value of the difference L1-L2 between the dimension L1 of the third surface of multiple microneedles 72 and the dimension L2 projected onto the adhesive layer 6 is large, which causes the molded microneedle sticker 8 to wrinkle and become a defective product.

[0165] Furthermore, the lower end of the first conveyor belt 1 is provided with a slot for the planar microneedles 7 to pass through, and the slot guides the conveying of the planar microneedles 7. The slot includes a first slot 11 and a second slot 12, which are arranged opposite to each other on both sides of the first conveyor belt 1.

[0166] Furthermore, this planar microneedle vertical device also includes a storage tank 4, which is located above the first conveyor belt 1 and at the upper end of the first conveyor belt 1. The storage tank 4 is used to store the planar microneedles 7 stacked vertically.

[0167] The bottom of the storage tank 4 is provided with an outlet for discharging the planar microneedles 7. Specifically, the outlet is similar in shape to the planar microneedles 7 but smaller in area, in order to store the planar microneedles 7. The outlet is arranged parallel to the first conveyor belt 1, and the distance between the outlet and the first conveyor belt 1 is greater than the thickness of the planar microneedles 7.

[0168] Furthermore, this planar microneedle vertical device also includes a negative pressure adsorber 5. The negative pressure adsorber 5 is disposed through the first conveyor belt 1 and is located below the center of the planar microneedles 7 in the storage tank 4. The negative pressure adsorber 5 can discharge pulsed negative pressure airflow to adsorb and spread the planar microneedles 7 layer by layer from the outlet onto the first conveyor belt 1. The negative pressure adsorber 5 can move in the axial direction, passing through the conveyor belt 1 and approaching the bottom of the storage tank 4 to discharge pulsed negative pressure airflow. When the needle-containing membrane 7 is drawn from the storage tank 4 onto the first conveyor belt 1, the negative pressure adsorber 5 stops discharging pulsed negative pressure airflow and retracts along the axial direction below the conveyor belt 1. The specific process is as follows:

[0169] Since the negative pressure adsorber 5 is located below the center of the planar microneedle 7 in the storage tank 4, the adsorption force applied by the negative pressure adsorber 5 to the planar microneedle 7 acts on the center of the planar microneedle 7. After the planar microneedle 7 is deformed, it is discharged from the outlet. The center of the planar microneedle 7 first attaches to the first conveyor belt 1. Then, the adsorption force forms a pulling force at the edge of the planar microneedle 7. Under the action of this pulling force, the edge of the planar microneedle 7 extends and spreads flat on the first conveyor belt 1, so as to realize the transfer of the planar microneedle 7 from the storage tank 4 and the spreading flat on the first conveyor belt 1.

[0170] In the description of this specification, the terms "one embodiment," "some embodiments," "embodiment," "example," "specific example," or "some examples," etc., refer to specific features, structures, materials, or characteristics described in connection with that embodiment or example, which are included in at least one embodiment or example of the present invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples. Moreover, without contradiction, those skilled in the art can combine and integrate the different embodiments or examples described in this specification, as well as the features of different embodiments or examples.

[0171] Although embodiments of the present invention have been shown and described above, it is understood that the above embodiments are exemplary and should not be construed as limiting the present invention. Those skilled in the art can make modifications, alterations, substitutions and variations to the above embodiments within the scope of the present invention.

Claims

1. A planar microneedle, characterized by, It includes a base layer (71) and a microneedle (72) that can be flipped onto the base layer (71). The microneedle (72) includes a needle tip (721), a needle seat (723), and a middle part (722) connecting the needle tip (721) and the needle seat (723). The direction of the needle tip (721) toward the needle seat (723) is the same as the extension direction of the base layer (71). The tip (721) of the microneedle (72) is formed by drying the drug-loaded raw material liquid; The base layer (71), the middle part (722) of the microneedle (72), and the needle seat (723) of the microneedle (72) are all formed by drying the base raw material liquid; The microneedle (72) includes a first surface (724), a second surface (725) and a third surface (726). The first surface (724) and the base layer (71) are located on the same plane. The third surface (726) is connected to the base layer (71). The microneedle (72) is subjected to a reaction force from the adhesive layer (6) and can be flipped around the connection between the third surface (726) and the base layer (71) so that the third surface (726) is flipped to be parallel to the base layer (71). The third surface (726) can be bonded to the adhesive layer (6). The microneedle patch (8) has an adhesive layer (6) on one side of the base layer (71) near the needle seat (723).

2. The planar microneedle of claim 1, wherein, The ratio of the maximum depth of the microneedle (72) perpendicular to the base layer (71) to the maximum length parallel to the base layer (71) is 1:(2-5).

3. The planar microneedle of claim 1, wherein, The angle between the first surface (724) and the third surface (726) is 45°-90°, the angle between the second surface (725) and the third surface (726) is 60°-90°, and the angle between the first surface (724) and the second surface (725) is 15°-45°.

4. The planar microneedle of claim 1, wherein, The second surface (725) extends outward along the width direction of the microneedle (72) to form a protrusion (727).

5. The apparatus for manufacturing a planar microneedle according to any one of claims 1 to 4, wherein Includes a base (110), a mold (120), and a panel (130) located above the base (110); The top of the base (110) is provided with a receiving groove (111) for accommodating the mold (120). The top of the mold (120) is provided with multiple recessed grooves (121) for forming microneedles (72). The forming groove (121) includes a needle tip groove (1211), a needle seat groove (1213), and a central groove (1212) connecting the needle tip groove (1211) and the needle seat groove (1213). The direction of the needle tip groove (1211) toward the needle seat groove (1213) is horizontal. The panel (130) is provided with a plurality of molding grooves (121) for accommodating the mold (120) and molding holes (131) for molding the base layer (71). The top of the mold (120) protrudes upward to form an isolation portion (122), which is circumferentially arranged around the side wall (1214) of the forming groove (121); When the mold (120) is fitted into the receiving groove (111) of the base (110) and the panel (130) is pressed against the top of the base (110) and the mold (120), the height of the isolation part (122) is at least the same as the height of the panel (130).

6. The fabrication equipment for planar microneedles as described in claim 5, characterized in that, The ratio of the maximum depth to the maximum length of the forming groove (121) is 1:(2-5).

7. The fabrication equipment for planar microneedles as described in claim 5, characterized in that, The angle between the bottom wall (1215) of the forming groove (121) and the top of the mold (120) is 45°-90°, the angle between the bottom wall (1215) and the side wall (1214) of the forming groove (121) is 60°-90°, and the angle between the side wall (1214) and the top of the mold (120) is 15°-45°.

8. The manufacturing equipment for planar microneedles as described in claim 5, characterized in that: The isolation portion (122) extends outward along the width direction of the forming groove (121) to form a protrusion (123), which is used to form the protrusion (727) of the microneedle (72).

9. The method for preparing planar microneedles according to any one of claims 1-4, characterized in that, The preparation method includes the following steps: S1: Assemble the base (110), mold (120) and panel (130); S2: Inject the drug-loaded liquid into the needle tip groove (1211) of the mold (120) and dry it to form the needle tip (721) of the microneedle (72). S3: After injecting raw material liquid into the central groove (1212), pin seat groove (1213) of the mold (120) and the forming hole (131) of the panel (130), the raw material liquid is scraped flat along the top of the panel (130). The raw material liquid in the forming hole (131) is dried to form the base layer (71), the raw material liquid in the needle seat groove (1213) of the mold (120) is dried to form the needle seat (723) of the microneedle (72), and the raw material liquid in the middle groove (1212) of the mold (120) is dried to form the middle part (722) of the microneedle (72).

10. The method for preparing planar microneedles as described in claim 9, characterized in that, Step S3 also includes: After injecting the raw material liquid into the molding hole (131) of the panel (130), the drug-loaded liquid is scraped flat along the needle tip groove (1211) of the mold (120) toward the needle seat groove (1213); Alternatively, inject raw material liquid into the molding hole (131) of the panel (130) until the molding hole (131) is filled, scrape the raw material liquid along the top of the panel (130) and then draw a vacuum; Alternatively, inject raw material liquid into the molding hole (131) of the panel (130) until the molding hole (131) is filled, scrape the raw material liquid along the top of the panel (130) and then centrifuge.

11. A microneedle patch, comprising the planar microneedles according to any one of claims 1-4, characterized in that, It also includes an adhesive layer (6), the microneedles (72) can be flipped from a first side (724) parallel to the base layer (71) to a third side (726) parallel to the base layer (71), and the third side (726) is adhered to the adhesive layer (6) to form the microneedle patch (8).

12. A microneedle-attached vertical device, comprising the planar microneedles as described in any one of claims 1-4, characterized in that, It also includes conveyor belt components and microneedle flipping components; The conveyor belt assembly is used to convey the planar microneedles (7) and the adhesive layer (6). The microneedle flipper is located at the junction of the planar microneedle (7) and the adhesive layer (6); The microneedle flipping component is used to adhere the base layer (71) to the adhesive layer (6) and flip the microneedle (72) from the first side (724) parallel to the base layer (71) to the third side (726) parallel to the base layer (71), and make the third side (726) adhere to the adhesive layer (6) to complete the microneedle upright shape.

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