WO2023197672A1 - 一种平面微针、微针贴及制造设备、立形设备和制备方法 - Google Patents

一种平面微针、微针贴及制造设备、立形设备和制备方法 Download PDF

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Publication number
WO2023197672A1
WO2023197672A1 PCT/CN2022/141169 CN2022141169W WO2023197672A1 WO 2023197672 A1 WO2023197672 A1 WO 2023197672A1 CN 2022141169 W CN2022141169 W CN 2022141169W WO 2023197672 A1 WO2023197672 A1 WO 2023197672A1
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WO
WIPO (PCT)
Prior art keywords
microneedle
planar
side wall
groove
base layer
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Application number
PCT/CN2022/141169
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English (en)
French (fr)
Inventor
李成国
冷钢
马永浩
陈锦永
陈莲华
李燕芬
Original Assignee
优微(珠海)生物科技有限公司
珠海科瑞微医药科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
Priority claimed from CN202210399470.4A external-priority patent/CN114748783A/zh
Priority claimed from CN202210556442.9A external-priority patent/CN114849053B/zh
Priority claimed from CN202210556439.7A external-priority patent/CN114889042B/zh
Application filed by 优微(珠海)生物科技有限公司, 珠海科瑞微医药科技有限公司 filed Critical 优微(珠海)生物科技有限公司
Publication of WO2023197672A1 publication Critical patent/WO2023197672A1/zh

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin

Definitions

  • the invention belongs to the technical field of microneedle, and specifically relates to a planar microneedle, a microneedle patch and manufacturing equipment, a vertical equipment and a preparation method.
  • the microneedle patch mainly includes a basal layer and microneedles arranged on the basal layer.
  • the microneedle patch is mainly formed by a mold.
  • the drug-carrying liquid is poured into the molding groove of the mold by high-pressure injection or vacuum suction, and microneedles extending in a direction perpendicular to the basal layer are directly formed.
  • the tip of the microneedle is the drug-carrying area. Since the depth and depth-to-aspect ratio of the molding groove used to mold microneedles are both large, when the drug-carrying liquid is spray-infused, the drug-carrying liquid will spread around in a fan shape, causing the drug-carrying liquid to splash into the molding groove corresponding to the molded microneedles.
  • the drug-carrying liquid enters the needle tip position through the needle seat and the middle position of the molded microneedle in the molding tank, so that the needle tip, middle part and needle seat of the molded microneedle All contain medicine.
  • this microneedle as the depth of the microneedle entering the skin is different, the amount of medication injected by the patient is also different. The precise dosage cannot be controlled, and because the drug-loaded liquid in the molding tank is difficult to remove, it leads to contamination of the molding tank. , affecting other batches of microneedles. Furthermore, due to the large depth and depth-to-aspect ratio of the molding groove, the demoulding resistance after microneedle molding is large and difficult to demould.
  • microneedle that can concentrate the drug-loaded liquid at the needle tip, as well as a manufacturing equipment and preparation method for molding the microneedle.
  • the present invention provides a planar microneedle, a microneedle patch and a vertical shape, manufacturing equipment and preparation method, which are suitable for two-step molding of microneedle patches.
  • the molding method first forms The first side wall of the microneedle is on the same plane as the basal layer.
  • the microneedle is then adjusted by the flat microneedle vertical device until the angle between the third side wall of the microneedle and the plane of the basal layer is 0°.
  • a planar microneedle includes a base layer and a microneedle reversibly disposed on the base layer.
  • the microneedle includes a needle tip, a needle base and a middle portion connecting the needle tip and the needle base.
  • the needle tip faces toward the desired location.
  • the direction of the needle seat is the same as the extending direction of the base layer.
  • the planar microneedles are filled and dried with raw material liquid.
  • the microneedle includes a first side wall, a circumferential side wall and a third side wall.
  • the first side wall and the circumferential side wall are located in the circumferential direction of the microneedle.
  • the third side wall The wall is located at the base of the microneedles.
  • the first side wall and the base layer are located on the same plane, the third side wall is connected to the base layer, and the microneedle can be flipped around the connection between the third side wall and the base layer.
  • the third side wall includes a first side, and the first side connects the side of the base layer away from the first side wall.
  • the microneedle can be rotated around the first side with the third side wall facing the first side wall until the angle between the third side wall and the plane of the basal layer is 0° ⁇ ⁇ 10°, the junction between the microneedle and the base layer forms a base through hole.
  • the microneedle can rotate around the first side until the third side wall portion abuts the side of the base layer close to the microneedle, and the third side wall includes a
  • the angle ⁇ between the movable edge and the side wall of the base through hole has a value range of 0° ⁇ 10°.
  • the ratio of the maximum depth of the microneedle perpendicular to the basal layer to the maximum length parallel to the basal layer is 1:5 to 1:2.
  • a microneedle patch which includes the above-mentioned planar microneedles.
  • the microneedle patch also includes an adhesive layer.
  • the microneedle includes a first side wall, a circumferential side wall and a third side wall.
  • the first side wall and the circumferential side wall are located in the circumferential direction of the microneedle.
  • the third side wall is located at the circumferential direction of the microneedle. Describe the bottom of the microneedle.
  • the first side wall and the basal layer are located on the same plane, the third side wall is connected to the basal layer, and the microneedle can be flipped around the connection between the third side wall and the basal layer, so that The microneedles and the side of the base layer away from the microneedles are both adhered to the adhesive layer.
  • a planar microneedle manufacturing equipment is used to manufacture the above-mentioned planar microneedle, including a base, a mold and a panel located above the base.
  • the top of the base is provided with a groove for accommodating the mold.
  • the top of the mold is provided with a plurality of recessed molding grooves for molding microneedles.
  • the molded groove includes a needle tip groove, a needle seat groove and a middle groove.
  • the middle groove communicates with the needle tip groove and the needle seat groove.
  • the direction of the needle tip groove towards the needle seat groove is a horizontal direction.
  • the panel is provided with molding holes for accommodating all the molding grooves of the mold, and the molding holes are used for molding the base layer.
  • the top of the mold protrudes upward to form an isolation portion, and the isolation portion is arranged around the circumference of the side wall of the forming groove.
  • the height of the isolation part is greater than or equal to the height of the panel.
  • the bottom wall of the molding groove extends outward to form a convex portion forming groove, and the convex portion forming groove is used to shape the microneedles.
  • the raised portion on the third side wall is used to shape the microneedles.
  • the length of the lower edge is greater than the length of the lower edge and the upper edge of the forming groove bottom wall.
  • the length of the connecting line between the two intersection points of the forming groove is greater than the length of the lower edge and the upper edge of the forming groove bottom wall.
  • A1 Assemble the base, mold and panel.
  • A2 Inject the drug-carrying liquid into the needle tip groove of the mold and dry it to form the needle tip of the microneedle.
  • A3 After injecting the 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.
  • the raw material liquid in the molding hole is dried into the base layer, the raw material liquid in the needle seat groove of the mold is dried into the needle seat of the microneedle, and the raw material liquid in the middle groove of the mold is dried into The middle part of the microneedle.
  • step A3 also includes:
  • the drug-loaded liquid After injecting the raw material liquid into the molding hole of the panel, the drug-loaded liquid is scraped along the needle tip groove of the mold toward the needle base groove.
  • the raw material liquid is injected into the molding hole of the panel until the molding hole is covered, the raw material liquid is scraped along the top of the panel, and then the vacuum is evacuated.
  • a planar microneedle erecting device is used to erect the above-mentioned planar microneedle, and includes a planar microneedle transmission component and a planar microneedle turning component.
  • the planar microneedle conveying assembly includes a planar microneedle conveying belt, and the planar microneedle conveying belt is used to convey the planar microneedle to the planar microneedle turning assembly.
  • the planar microneedle turning component is used to apply pressure on the microneedles of the planar microneedle to turn the microneedles around the connection between the third side wall and the base layer, so that the microneedles are moved from the third side wall to the base layer.
  • the side wall and the basal layer are on the same plane and turned over until the angle between the third side wall and the basal layer is 0° to ⁇ 10° to complete the microneedle erection.
  • the planar microneedle turning component can be a vacuum negative pressure adsorption adhesive member, and the vacuum negative pressure adsorption adhesive member is used to apply negative pressure airflow to the microneedle from the bottom of the microneedle.
  • the planar microneedle turning component is an air pressure adhesive member, and the air pressure adhesive member is used to apply airflow to the microneedles from above.
  • the planar microneedle turning component is a roller contacting pressing member, and the roller contacting pressing member is used to roll on the planar microneedle to exert pressure on the microneedle.
  • the planar microneedle turning assembly may include a turning mechanism and a microneedle receiving mechanism.
  • the turning mechanism is a pressing plate.
  • the turning mechanism is used to apply pressure on the microneedle, so that the microneedle rotates around the first side and into the accommodation groove located at the top of the microneedle accommodation mechanism to complete the upright shape of the microneedle. .
  • a plurality of pressure applying portions are provided at the bottom of the pressure plate, and the plurality of pressure applying portions and the plurality of receiving grooves are provided in one-to-one correspondence.
  • the longitudinal section of the pressure applying portion is a downwardly protruding arc or V-shape.
  • the planar microneedle turning assembly may also include a turning mechanism and a microneedle receiving mechanism.
  • the flipping mechanism includes a first roller, which is used to press the microneedle to rotate the microneedle around the first side to a receiving groove located at the top of the microneedle receiving mechanism. to complete the microneedle shape.
  • the first roller and the microneedle accommodating mechanism can move toward each other.
  • the turning mechanism also includes a second roller and a third roller.
  • An adhesive layer is wound around the second roller, the second roller is used to transfer the adhesive layer to the first roller, and the third roller is used to wrap and store the adhesive layer on the first roller.
  • the protective film obtained by tearing off the adhesive layer, the first roller is used to apply pressure to the microneedle, and adhere the adhesive layer to the side of the base layer away from the microneedle and the microneedle superior.
  • a protective film peeling structure is provided on the side of the first roller close to the third roller, and the protective film peeling structure is used to control the position at which the protective film is peeled off from the adhesive base.
  • the microneedle accommodating mechanism also includes multiple sets of fixed plate assemblies arranged at intervals.
  • the fixed plate assembly includes a first clamping plate and a second clamping plate, and the first clamping plate can move in a direction toward or away from the second clamping plate.
  • the receiving groove is formed between the first clamping plate and the second clamping plate.
  • the first clamping plate and the second clamping plate clamp the microneedle.
  • a limiting plate is provided at one end of the microneedle accommodating mechanism away from the planar microneedle delivery component, and the planar microneedle abuts against the limiting plate.
  • the planar microneedle conveying assembly includes a planar microneedle conveying belt and a vertical conveying belt.
  • the planar microneedle conveyor belt is arranged at an angle and is used to convey the planar microneedles.
  • the vertical conveyor belt is arranged horizontally and is located at the lower end of the planar microneedle conveyor belt.
  • the vertical conveyor belt is used to convey a sticky adhesive layer. , and accepts the planar microneedles from the planar microneedle conveyor belt.
  • the angle between the extension direction of the planar microneedle conveyor belt and the extension direction of the vertical conveyor belt is 135°-179°.
  • the first side wall and the base layer are located on the same plane.
  • the direction of the needle tip groove for molding the needle tip toward the needle seat groove for molding the needle seat is a horizontal direction to reduce the size of the molding groove. Depth, and reduce the ratio of the maximum depth to the maximum length of the forming tank, which facilitates the accurate filling of the raw material liquid into the needle tip groove of the forming tank. It is suitable for the infusion of oil-water mixture or raw material liquid with high viscosity, and can avoid the splashing of the raw material liquid.
  • reducing the depth of the molding groove and the ratio of the maximum depth to the maximum length can also reduce the demoulding resistance between the microneedle molding and the molding groove, avoid microneedle breakage, improve the yield rate of microneedles, and reduce costs.
  • Figure 1 is a three-dimensional schematic view of a planar microneedle according to Embodiment 1 of the present invention.
  • FIG. 2 is a three-dimensional schematic diagram of the microneedle patch according to Embodiment 2 of the present invention (the microneedles are square pyramids);
  • Figure 3 is a schematic diagram of Figure 2 from another perspective
  • Figure 4 is a partially enlarged schematic diagram of Figure 3;
  • Figure 5 is a three-dimensional schematic view of the microneedle patch according to Embodiment 2 of the present invention (the microneedle is a quadrangular pyramid, and the third side wall of the microneedle is provided with a protrusion);
  • Figure 6 is a partially enlarged schematic diagram of Figure 5;
  • Figure 7 is a schematic three-dimensional view of the microneedle patch according to Embodiment 2 of the present invention (the microneedles are pentagonal pyramids, and the third side wall of the microneedles is provided with a protruding portion);
  • Figure 8 is a three-dimensional schematic diagram of the microneedle patch according to Embodiment 2 of the present invention (the microneedles are cones or elliptical cones);
  • Figure 9 is a three-dimensional schematic view of the microneedle patch according to Embodiment 2 of the present invention (the microneedle is a triangular pyramid, and protrusions are provided on both sides of the first side wall of the microneedle);
  • Figure 10 is a three-dimensional schematic view of the microneedle patch according to Embodiment 2 of the present invention (the microneedle is a quadrangular pyramid, and protrusions are provided on both sides of the first side wall and the second side wall of the microneedle);
  • Figure 11 is a three-dimensional schematic view of the microneedle patch according to Embodiment 2 of the present invention (the microneedle is a quadrangular pyramid, protrusions are provided on both sides of the first side wall and the second side wall of the microneedle, and the third side of the microneedle The wall is provided with a raised portion);
  • Figure 12 is an exploded view of the planar microneedle molding equipment according to Embodiment 3 of the present invention.
  • Figure 13 is an assembly diagram of Figure 12
  • Figure 14 is an exploded view of the mold and planar microneedles in Figure 12;
  • Figure 15 is a three-dimensional schematic view of the mold in Figure 12 (the length of the lower side of the bottom wall of the molding groove is greater than the length of the upper side);
  • Figure 16 is a three-dimensional schematic view of the mold in Figure 12 (the bottom wall of the molding groove is provided with a protrusion to form a groove);
  • Figure 17 is a schematic view of the forming groove in Figure 16 from another perspective
  • Figure 18 is a work flow chart of the planar microneedle vertical device in Embodiment 5 of the present invention (the turning mechanism is a pressure plate);
  • Figure 19 is a workflow diagram of the planar microneedle flipping assembly in Figure 18;
  • Figure 20 is a partial enlarged view of Figure 19 (before microneedle erection);
  • Figure 21 is a partial enlarged view of Figure 19 (after the microneedle is established);
  • Figure 22 is a perspective view of Figure 18
  • Figure 23 is a partial enlarged view of Figure 22 (before microneedle erection);
  • Figure 24 is a partial enlarged view of Figure 22 (after the microneedle is erected);
  • Figure 25 is a schematic diagram of the process of using pressure plate vertical microneedles
  • Figure 26 is a schematic diagram of the pressure plate in Figure 25 provided with a pressure applying portion (the longitudinal section of the pressure applying portion is a downwardly protruding arc);
  • Figure 27 is a schematic diagram of the pressure plate in Figure 25 provided with a pressure applying portion (the longitudinal section of the pressure applying portion is a downwardly protruding V-shape);
  • Figure 28 is a work flow chart of the planar microneedle vertical device in Embodiment 5 of the present invention (the flipping mechanism is a roller assembly);
  • Figure 29 is a partial enlarged view of Figure 28;
  • Figure 30 is a perspective view of Figure 28;
  • Figure 31 is a partial enlarged view of Figure 30 (the microneedle is a square pyramid, and after the microneedle is erect, the third side of the third wall of the microneedle abuts the side of the basal layer close to the microneedle);
  • Figure 32 is a partial enlarged view of Figure 30 (the microneedles are triangular pyramids and are provided with protruding structures);
  • Figure 33 is a partial view of the planar microneedle delivery assembly
  • Figure 34 is a microneedle patch of the present invention (provided with an adhesive layer);
  • Figure 35 is a front view of a planar microneedle vertical device using a vacuum negative pressure adsorption adhesive component as a microneedle flipping component;
  • Figure 36 is an enlarged view of D in Figure 35;
  • Figure 37 is a perspective view of Figure 35;
  • Figure 38 is a front view of a planar microneedle vertical device using an air pressure adhesive component as a microneedle turning component;
  • Figure 39 is an enlarged view of E in Figure 38;
  • Figure 40 is a perspective view of Figure 38
  • Figure 41 is a front view of a flat microneedle vertical device using a roller contact pressing part as a microneedle turning part;
  • Figure 42 is an enlarged view of F in Figure 41;
  • Fig. 43 is a schematic perspective view of Fig. 41.
  • this embodiment provides a planar microneedle, which includes a base layer 11 and microneedles 12 .
  • the microneedles 12 are arranged on the base layer 11 .
  • the microneedle 12 includes a needle tip 124, a middle part 125 and a needle seat 126.
  • the middle part 125 connects the needle tip 124 and the needle seat 126.
  • the direction of the needle tip 124 toward the needle seat 126 is basically the same as the extension direction of the base layer 11.
  • the microneedles 12 are formed by the forming grooves 321 in the mold 32 .
  • the direction of the needle tip groove 3212 for molding the needle tip 124 toward the needle seat groove 3214 for molding the needle seat 126 is substantially horizontal, which can reduce the depth of the molding groove 321 and reduce the depth of the molding groove 321
  • the ratio of the maximum depth to the maximum length facilitates accurate filling of the raw material liquid into the needle tip groove 3212 of the forming groove 321, and is not limited to the type of the raw material liquid.
  • the molding groove 321 is set horizontally, when the raw material liquid is poured into the needle tip groove 3212, it does not need to pass through the middle groove 3213 and the needle seat groove 3214, and can be poured directly into the needle tip groove 3212, thereby preventing the raw material liquid from splashing and contaminating the middle groove 3213 and the needle seat groove 3214. , so that the molded microneedle 12 is only loaded with medicine at the needle tip 124, so as to accurately control the drug dosage of the microneedle patch 2 during use.
  • the ratio of the maximum depth to the maximum length of the molding groove 321 can also reduce the demoulding resistance between the microneedle 12 and the molding groove 321 after molding, avoid the breakage of the microneedle 12, improve the yield rate of the microneedle 12, and Can reduce costs.
  • the size of the needle tip groove 3212 can be larger than the middle groove 3213 and/or the needle seat groove 3214 along the horizontal direction, so that the microneedle 12 can form the protruding structure 128 and other structures to prevent detachment from the skin. , such as arrow type, Tasong type, half gourd type, etc., and can facilitate the demoulding of the microneedle 12.
  • the ratio of the maximum width to the maximum height of the microneedle 12 is 1:5 ⁇ 1:2.
  • the ratio between the maximum depth and the maximum length of the molding groove 321 used to mold the microneedles 12 is 1:5 ⁇ 1:2.
  • the microneedle 12 is a cone body, and the microneedle 12 can be a pyramid, a cone or an elliptical cone.
  • the microneedle 12 when the microneedle 12 is a pyramid: the microneedle 12 includes a first side wall 121, a circumferential side wall and a third side wall 123.
  • the first side wall 121 is located on the same plane as the base layer 11
  • the first side wall 121 and the circumferential side wall are located in the circumferential direction of the microneedle 12
  • the third side wall 123 is located at the bottom of the microneedle 12 .
  • the circumferential sidewall includes at least two second sidewalls 122 .
  • the circumferential side wall includes an arcuate wall 129.
  • the flat microneedle 1 needs to be erected before it can be used to pierce the skin and introduce drugs into the skin.
  • the erecting process of the microneedle 12 is as follows: the microneedle 12 is flipped around the first side 1231 and passes through the gap 111, and is flipped from the first side wall 121 of the microneedle 12 and the base layer 11 to being in the same plane to the third side wall 123 and
  • the base layer 11 is generally on the same plane or partially against the base layer 11 , that is, the angle between the third side wall 123 and the plane of the base layer 11 is 0° to ⁇ 10° (when the third side wall 123 is inclined to the base layer 11 and When located below the base layer 11 , the angle between the third side wall 123 and the plane of the base layer 11 is greater than or equal to -10° and less than 0°; when the third side wall 123 is inclined to the base layer 11 and is located at the base layer 11 when the angle between the third side wall 123 and the plane of
  • the base through hole 112 is formed at the junction of the microneedle 12 and the base layer 11; when the third side wall 123 is located in the base through hole 112 and is substantially parallel to the base layer 11 or the third side wall 123 is partially against the base When the base layer 11 is on the base layer 11 , the angle between the third side wall 123 and the plane of the base layer 11 is 0°.
  • the direction of the needle tip 124 of the microneedle 12 toward the needle seat 126 is perpendicular to or intersects with the basal layer 11.
  • the direction of pressing the microneedle patch 2 is consistent with
  • the direction of the needle base 126 towards the needle tip 124 is basically coincident.
  • the microneedle 12 can be smoothly inserted into the skin. At this time, the transverse shear force endured by the microneedle 12 is almost zero, which can effectively avoid the use of microneedle patch 2.
  • the microneedles 12 are broken.
  • microneedles 12 are pyramids:
  • the angle ⁇ between the first side wall 121 and the third side wall 123 is 45°-90°. This angle affects the ease of demoulding of the microneedle 12 after molding and the performance of the microneedle patch 2 .
  • is greater than 90°, demolding of the microneedles 12 after molding cannot be completed.
  • is less than 45°, after the microneedle 12 is erected, the angle between the first side wall 121 of the microneedle 12 and the basal layer 11 is small, causing the tip 124 of the microneedle 12 to face the needle seat 126 in the direction of the basal layer 11 The inclination angle between them is small. When used, the microneedle 12 cannot penetrate into the skin, or the resistance of the microneedle 12 to penetrate into the skin is too great, causing the microneedle 12 to break, affecting the normal use of the microneedle patch 2 .
  • the angle ⁇ between the second side wall 122 and the third side wall 123 is 60°-90°, and this angle affects the volume and shape of the microneedle 12 .
  • is less than 60°, the width of the needle seat 126 is large.
  • the width of the needle seat 126 is large, causing the needle seat 126 to remain in the stratum corneum and unable to penetrate into the target layer, affecting the microneedle 12
  • the drug administration stability after being inserted into the skin will be wasted, and the molding material at the needle seat 126 will be wasted.
  • the angle between the second side wall 122 and the third side wall 123 of the microneedle 12 is larger, resulting in a smaller height of the microneedle 12 after the erection, and the microneedle 12 after the erection,
  • the angle between the direction of the needle tip 124 toward the needle seat 126 and the inclination angle of the basal layer 11 is relatively large.
  • the angle between the direction of the external force and the direction of the needle tip 124 toward the needle seat 126 is large, which may easily cause the microneedle 12 to The microneedle 12 cannot be penetrated into the skin, or the microneedle 12 is broken due to the high penetration resistance, affecting the normal use of the microneedle patch 2 .
  • the third side wall 123 includes a first side 1231 and a movable side, and the first side 1231 is connected to the base layer 11 .
  • the movable side includes at least one second side 1232 and at least one third side 1233 .
  • the first side 1231 is connected to the base layer 11 , and the first side 1231 and at least one third side 1233 are arranged oppositely.
  • the second side 1232 connects the first side 1231 and the third side 1233 .
  • the third side wall 123 when the microneedle 12 is a triangular pyramid, the third side wall 123 includes a first side 1231 , a second side 1232 and a third side 1233 .
  • the third side wall 123 when the microneedle 12 is a quadrangular pyramid, the third side wall 123 includes a first side 1231, two second sides 1232 and a third side 1233.
  • the first side 1231 and the third side 1233 are arranged oppositely, and the two second sides 1232 They are arranged oppositely and both connect the first side 1231 and the third side 1233 .
  • the third side wall 123 when the microneedle 12 is a pentagonal pyramid, the third side wall 123 includes a first side 1231, two second sides 1232 and two third sides 1233.
  • the first side 1231 and the two third sides 1233 are arranged oppositely.
  • the second sides 1232 are arranged opposite to each other and are connected to the first side 1231 and the third side 1233 .
  • the edges of the microneedle 12 are greater than or equal to four, the first side 1231 of the third side wall 123 and at least one third side 1233 are arranged oppositely, and the second side 1232 connects the first side 1231 and the third side. Side 1233.
  • the microneedle 12 has four or more edges, and the movable edges include at least two second edges 1232 and at least one third edge 1233 .
  • the first side 1231 is connected to the base layer 11
  • the first side 1231 and the third side 1233 are arranged oppositely
  • the second side 1232 is connected to the first side 1231 and the third side 1233 .
  • the microneedle 12 can be flipped around the first side 1231, and flipped from the first side wall 121 and the base layer 11 on the same plane to the third side 1233 of the third side wall 123 against the base layer. 11 is close to the side of microneedle 12.
  • the third side wall 123 of the microneedle 12 When the microneedle 12 is erect, the third side wall 123 of the microneedle 12 partially abuts the base layer 11 , and the connecting length of the two connection points FG between the third side 1233 and the second side 1232 of the third side wall 123 is is greater than the length of the projected side AB formed by the projection of the connecting line on the base through hole 112, so that the third side 1233 of the third side wall 123 of the microneedle 12 can abut against the base layer 11.
  • the third side The wall 123 forms a polygonal contact surface on the base layer 11 (the contact surface is surrounded by HAF or IGB on the base layer 11 ), so that the third side wall 123 can stably abut against the base layer 11 .
  • the area of the third side wall 123 is larger than the area of the base through hole 112 corresponding to the third side wall 123, so that the third side wall 123 Partially rests on the base layer 11 to support the base layer 11 to achieve a stable erect shape of the microneedle 12 and prevent the microneedle 12 from rebounding and reversing around the first edge 1231 after the flipping force exerted on the microneedle 12 is cancelled. Rotate.
  • the length of the connection point FG between the third side 1233 and the second side 1232 of the third side wall 123 is less than or equal to the length of the first side 1231 (that is, the length of HI), so that after the microneedle 12 is formed, of demoulding.
  • the third side 1233 of the third side wall 123 of the microneedle 12 abuts the side of the base layer 11 close to the microneedle 12, the second side adjacent to the first side 1231
  • the value range of the angle ⁇ between 1232 and the side wall of the base through hole 112 is 0° ⁇ 10°.
  • is greater than 10°, the turning resistance of the microneedle 12 is likely to increase, resulting in damage to the microneedle 12 when it is standing. More preferably, 1° ⁇ 6°.
  • the movable edge includes an arc edge 1234.
  • the microneedle 12 can be flipped around the first side 1231 and flipped from the first side wall 121 and the base layer 11 on the same plane to the arc edge 1234 of the third side wall 123 abutting the side of the base layer 11 close to the microneedle 12 .
  • the arc edge 1234 of the third side wall 123 abuts the side of the base layer 11 close to the microneedle 12
  • the arc edge 1234 and the base through hole 112 intersect at points J and K, so that the third side A contact surface is formed between the wall 123 and the base layer 11 , thereby enabling the third side wall 123 to stably abut against the base layer 11 .
  • the area of the third side wall 123 is larger than the area of the base through hole 112 corresponding to the third side wall 123, so that the third side wall 123 Partially rests against the base layer 11 to support the base layer 11 to achieve a stable upright shape of the microneedle 12 and prevent the microneedle 12 from rebounding and rotating reversely around the first side 1231 after the flipping force exerted on the microneedle 12 is cancelled. .
  • the third side 1233 or the arcuate side 1234 of the third side wall 123 is arranged to abut against the base layer 11 , thereby improving the gripping force between the microneedle 12 and the base layer 11 to ensure
  • the third side wall 123 of the microneedle 12 stably presses against the basal layer 11 to prevent the microneedle 12 from rebounding and causing the third side wall of the microneedle 12 to rebound after the turning force exerted on the microneedle 12 disappears during the erection process of the microneedle 12 .
  • Adhesive layer 21 The microneedle patch 2 without the adhesive layer 21 can be suitable for use by people who are allergic to the material of the adhesive layer 21 .
  • protruding structures 128 are provided on both sides of the first side wall 121 of the microneedle 12.
  • the protruding structures 128 extend along the needle tip 124 toward the needle seat 126 to form a barb shape, and the protruding structures 128 are located at the needle tip. 124.
  • the microneedle 12 to prevent the microneedle 12 from being squeezed out of the skin under the action of skin resilience, and because the gripping force between the microneedle 12 and the skin is large enough, the stickiness used to adhere to the skin can be canceled on the microneedle patch 2 Layer 21 for people who are sensitive to sticky glue.
  • a protruding structure 128 is provided on the second side wall 122 opposite to the first side wall 121.
  • the protruding structure 128 extends along the direction of the needle tip 124 toward the needle seat 126 to form a barb shape, and the protruding structure 128 is preferably located on the needle tip 124 .
  • a protruding structure 128 is provided on the arc wall 129.
  • the protruding structure 128 extends along the needle tip 124 toward the needle seat 126 to form a barb shape.
  • the protruding structure 128 is preferably located at the needle tip 124.
  • the microneedle 12 is formed. At this time, the raw material liquid can be accurately injected into the second protrusion-making groove, and the drug loading amount of the formed microneedle 12 can be accurately controlled. More preferably, a plurality of protruding structures 128 are provided on the second side wall 122 or the arc-shaped wall 129, and a plurality of second molds for molding the plurality of protruding structures 128 are respectively provided in the molding groove 321 of the mold 32.
  • the molded microneedles 12 can carry a variety of drugs.
  • the third side wall 123 extends outward to form a raised portion 127 , and the raised portion 127 can pass through the base through hole 112 .
  • the planar microneedle 1 without the protruding portion 127 needs to be turned over to the side where the third side wall 123 of the microneedle 12 and the base layer 11 are close to the microneedle 12.
  • a larger included angle requires a larger turning force, which increases the difficulty in material and model selection of the turning mechanism that applies turning force to the microneedles 12 .
  • the microneedle 12 only needs to be turned over until the raised portion 127 is flush with the side of the base layer 11 away from the microneedle 12.
  • the third side wall 123 of the microneedle 12 The angle between the side of the basal layer 11 and the side close to the microneedle 12 is smaller, thereby reducing the flipping force exerted on the microneedle 12 , making it easier for the microneedle 12 to stand upright, and reducing the risk of applying a flipping force to the microneedle 12 Difficulty in selecting materials and models for the flipping mechanism.
  • the maximum height of the protrusion 127 is greater than or equal to the thickness of the base layer 11, so that when the third side 1233 of the third side wall 123 of the microneedle 12 abuts the side of the base layer 11 close to the microneedle 12, The protruding portion 127 is flush with the side of the base layer 11 away from the microneedle 12 , or the protruding portion 127 protrudes from the side of the base layer 11 away from the microneedle 12 .
  • the maximum height of the protruding part 127 is less than the thickness of the base layer 11 , flipping the microneedle 12 until the protruding part 127 is flush with the side of the base layer 11 away from the microneedle 12 may easily cause the third side wall of the microneedle 12 to 123 does not pass through or does not completely pass through the base layer 11, so that the third side 1233 of the microneedle 12 cannot abut or cannot stably abut against the side of the base layer 11 close to the microneedle 12 to prevent the microneedle 12 from standing.
  • the microneedle 12 rebounds, causing the third side wall 123 of the microneedle 12 to tilt toward the base layer 11 .
  • the maximum height of the protrusion 127 is equal to the thickness of the base layer 11 .
  • the maximum height of the raised portion 127 is greater than the thickness of the base layer 11 , the raised portion 127 of the microneedle 12 protrudes from the side of the base layer 11 away from the microneedle 12 , and when formed into the microneedle patch 2 , it is easy to Because the side of the basal layer 11 away from the microneedle 12 is not a smooth plane, the comfort of use of the microneedle patch 2 and the aesthetics of the microneedle patch 2 are affected.
  • the protruding portion 127 may protrude from the side of the base layer 11 away from the microneedle 12, causing the adhesive layer 21 to be uneven.
  • this embodiment provides a microneedle patch. Specifically including the following two types:
  • the microneedle patch 2 when the microneedle 12 is erect, the side of the base layer 11 away from the microneedle 12 and the third side wall 123 or the convex portion 127 of the microneedle 12 adhere.
  • the microneedle patch 2 provided with the adhesive layer 21 is formed.
  • the microneedle patch 2 can stably adhere to the skin surface through the adhesive layer 21 exposed in the base through hole 112 after the microneedles 12 are inserted into the skin, so as to avoid the microneedles 12 being extruded under the action of skin elasticity and affecting the microneedle. Normal use of needle patch 2.
  • the microneedles 12 When the microneedle patch 2 is not provided with an adhesive layer 21: the microneedles 12 contain ingredients that are easily soluble in water, such as sodium hyaluronate, and the microneedle 12 is formed into a microneedle patch 2 without an adhesive layer 21 after being erected. .
  • the microneedle patch 2 When using the microneedle patch 2 without the adhesive layer 21, first point the needle tip 124 of the microneedle 12 toward the skin, and then press the microneedle patch 2 until the microneedle 12 is inserted into the skin. Apply pure water to the basal layer 11 to dissolve the basal layer 11 and the part of the microneedle 12 that has not entered the skin. Subsequently, the skin rebounds and closes the through hole formed when the microneedle 12 passes through the skin, so that the microneedle 12 is coated in the skin. In the skin, the microneedles 12 are dissolved and administered.
  • the basal layer 11 contains sodium hyaluronate
  • the sodium hyaluronate in the basal layer 11 is converted into a solution and forms a protective film on the skin surface to reduce water loss on the skin surface and thereby accelerate The dissolution speed of microneedles 12 inside the skin.
  • this kind of microneedle patch 2 without adhesive layer 21 is also suitable for children or other special patients and pets. It can prevent children or other special patients and pets from scratching the adhesive layer 21 when using the microneedle patch 2 and causing the microneedles 12 to sag.
  • the adhesive layer 21 is peeled off and the microneedle 12 cannot deliver medication.
  • the microneedle 12 is preferably provided with a protruding structure 128.
  • the protruding structure 128 on the microneedle 12 can penetrate into the skin for a second time, thereby increasing the grip between the microneedle 12 and the skin.
  • a plurality of protruding structures 128 are staggeredly arranged on both sides of the first side wall 121.
  • the protruding structures 128 are staggered on both sides of the first side wall 121.
  • the protruding structure 128 can reduce the cross-sectional area of the microneedle to reduce the resistance when the microneedle penetrates into the skin, thereby reducing skin damage and reducing pain.
  • an easy tearing opening is provided at the connection between the third side wall 123 of the microneedle with the protruding structure 128 and the base layer 11 , and the easy tearing opening is a gap formed at the connection between the third side wall 123 and the base layer 11 .
  • the microneedle 12 can be stably embedded into the skin to achieve rapid separation of the basal layer 11 and the microneedles 12, thereby preventing the basal layer 11 from adhering to the skin for a long time when the microneedle patch 2 is in use. It is especially suitable for use by children, pets or mentally ill patients, and can prevent the user from scratching or licking the base layer 11 to cause the microneedle patch 2 to fall off.
  • this embodiment provides a planar microneedle manufacturing equipment, which includes a base 31, a mold 32, and a panel 33 located above the base 31.
  • the top of the base 31 is provided with a groove 311 for receiving the mold 32.
  • a plurality of molding grooves 321 for molding the microneedles 12 are provided on the top of the mold 32 .
  • the molding groove 321 includes a needle tip groove 3212, a needle seat groove 3214 and a middle groove 3213.
  • the middle groove 3213 connects the needle tip groove 3212 and the needle seat groove 3214.
  • the direction of the needle tip groove 3212 of the molding groove 321 toward the needle seat groove 3214 is horizontal.
  • the panel 33 is provided with molding holes 331 for accommodating all the molding grooves 321 , and the molding holes 331 are used for molding the base layer 11 .
  • the top of the mold 32 protrudes upward to form an isolation portion 322 , and the isolation portion 322 is disposed around the circumference of the molding groove side wall 3216 of the molding groove 321 .
  • the height of the isolation portion 322 is at least consistent with the height of the panel 33 .
  • Microneedle manufacturing equipment in the prior art generally uses a raw material liquid to mold the microneedle patch 2 with the microneedle 12 extending perpendicularly to the direction of the base layer 11 in one go.
  • the ratio of the maximum depth to the maximum length of the molding groove 321 of the mold 32 is generally is 2-5.
  • the planar microneedle manufacturing equipment in this embodiment is used in the molding groove 321 of the microneedle 12.
  • the direction of the needle tip groove 3212 of the molding groove 321 toward the needle base groove 3214 is a horizontal direction.
  • the maximum depth of the molding groove 321 and The ratio of the maximum length is 1:5 ⁇ 1:2.
  • the forming groove 321 in this embodiment can greatly reduce the depth of the forming groove 321 and the ratio of the maximum depth to the maximum length. Therefore, the planar microneedle manufacturing equipment in this embodiment can, on the one hand, accurately inject the raw material liquid containing the pharmaceutical active ingredient into the needle tip groove 3212 of the molding groove 321, thereby preventing the raw material liquid from splashing and contaminating the middle groove 3213 and the needle seat groove 3214. , the middle groove 3213 and the needle seat groove 3214 of the molding groove 321 are filled with raw material liquid that does not contain drugs, so that the molded microneedles 12 are only loaded with drugs at the needle tips 124 to accurately control the drug delivery of the microneedle patch 2 during use. quantity.
  • the raw material liquid can be obtained without resorting to vacuum adsorption, centrifugation or high-pressure injection processes when preparing the microneedles 12 perfusion to shorten the preparation process and reduce costs.
  • the molding groove 321 is arranged in a substantially horizontal direction, the needle tip 124 and the middle part 125 of the microneedle 12 are not affected by the shape of the middle part 125 and/or the needle seat 126 when demoulding, and the volume of the needle tip 124 can be larger than the middle part 125 and/or the middle part 125.
  • the volume of the needle seat 126 that is, the microneedle 12 can be configured into an arrow-shaped, tower-shaped, gourd-shaped structure, or a combination of a semi-cone and a semi-circular cone arranged up and down, or a protruding structure 128 is formed on the microneedle tip 124.
  • the microneedles 12 have an arrow-shaped, tower-shaped, gourd-shaped structure, or a combination of a semi-cone and a semi-circular cone arranged up and down.
  • the needle tip 124 and/or the middle part 125 constitutes a larger protrusion of the microneedle 12 Part 127 improves the gripping force between the microneedle 12 and the skin. After the microneedle 12 is inserted into the skin, the skin is squeezed by the microneedle 12 and deformed. After the deformation recovers, the microneedle is embedded in the skin more stably. The microneedle 12 is more stable for the skin. The gripping force is greater.
  • raw material liquids such as high-viscosity raw material liquid and oil-water mixture raw material liquid can be easily injected into the molding tank 321 to meet the requirements of molding using raw material liquids such as high-viscosity raw material liquid and oil-water mixture raw material liquid.
  • Microneedle 12 needs.
  • the volume of droplets of high-viscosity raw material liquid is relatively large.
  • the existing microneedle preparation mold where microneedles are formed perpendicular to the base layer has a large depth-to-aspect ratio of the molding groove. After the droplets of high-viscosity raw material liquid are injected into the molding groove, the volume is large.
  • the entrance size of the forming groove 321 is also large, and the high-viscosity raw material liquid can be quickly and completely filled into the forming groove 321 by means of tools such as scraping the filling liquid, thereby achieving a high yield rate.
  • Industrialization reducing production costs and meeting demand.
  • planar microneedle manufacturing equipment in this embodiment can reduce the demoulding resistance between the microneedle 12 and the molding groove 321, avoid breakage of the microneedle 12, improve the yield of the microneedle 12, and reduce the cost.
  • the length of the lower side b of the bottom wall 3211 of the forming groove 321 is less than or equal to the length of the upper side a.
  • the lower side b of the bottom wall 3211 of the molding groove is correspondingly formed into the third side 1233 of the microneedle 12
  • the upper side a is correspondingly formed into the first side 1231 of the microneedle 12 .
  • the length of the lower side b of the bottom wall 3211 of the molding groove is greater than the length of the upper side a
  • the length of the third side 1233 of the formed microneedle 12 is greater than the length of the first side 1231.
  • demoulding the third side 1233 will contact the molding groove.
  • the length of the lower side b of the bottom wall 3211 of the molding groove is preferably less than or equal to the length of the upper side a, so that the length of the third side 1233 of the molded microneedle 12 is less than or equal to the length of the first side 1231 , so as to facilitate the demoulding of the microneedles 12 and the erection of the microneedles 12 .
  • the length of the lower side b is greater than the length of the line connecting the two intersections CD of the lower side b and the forming groove 321, so that After the molded microneedle 12 is erected, the length of the connecting line between the two connection points FG of the third side 1233 and the second side 1232 of the third side wall 123 of the microneedle 12 is greater than the length of the connecting line projected on the base through hole 112
  • the length of the formed projected side AB enables the third side 1233 of the microneedle 12 to abut the side of the base layer 11 close to the microneedle 12 .
  • the bottom wall 3211 of the molding groove extends outward to form a bulge forming groove 3215, and the bulge forming groove 3215 is used to form the third side of the microneedle 12 Projection 127 on wall 123.
  • the top of the mold 32 protrudes upward to form an isolation portion 322 , and the isolation portion 322 surrounds the circumferential direction of the molding groove side wall 3216 of the molding groove 321 .
  • the height of the isolation portion 322 is at least consistent with the height of the panel 33 .
  • the raw material liquid in the molding hole 331 is formed into the base layer 11
  • the raw material liquid in the molding groove 321 is formed into the microneedles 12 .
  • the isolation part 322 located at the top of the mold 32 blocks the raw material liquid, so that the formed base layer 11 forms a gap at the position corresponding to the isolation part 322, that is, the connection between the first side wall 121 and the second side wall 122 and the base.
  • the microneedles 12 can rotate around the first side 1231 and pass through the gap 111.
  • the first side wall 121 and the base layer 11 are on the same plane and flipped to the third position.
  • the side wall 123 is approximately on the same plane as the base layer 11 or partially abuts the base layer 11. At this time, the angle between the third side wall 123 and the base layer 11 is 0° to ⁇ 10°, completing the upright shape of the microneedle 12.
  • both sides of the isolation portion 322 protrude outward to form a first protrusion-making groove 323 , and the raw material liquid in the first protrusion-making groove 323 is used to shape the first side of the microneedle 12 Protruding structures 128 on both sides of wall 121 .
  • a second protruding groove is provided on the side wall 3216 of the forming groove 321 , and the second protruding groove is used to form the protruding structure 128 on the circumferential side wall of the microneedle 12 .
  • this example also provides a method for preparing planar microneedles. Specifically, it includes the following steps:
  • A1 Configure the raw material liquid, which includes drug-loaded raw material liquid and base raw material liquid.
  • A2 Assemble the base 31, the mold 32 and the panel 33. Place the mold 32 in the groove 311 of the base 31.
  • the molding hole 331 of the panel 33 is located above the mold 32 and accommodates all the molding grooves 321 of the mold 32.
  • A3 Fill the needle tip groove 3212 with the drug-loaded raw material liquid, and dry the drug-loaded raw material liquid into the needle tip 124 of the microneedle 12 .
  • A4 Fill the base material liquid into the molding hole 331 until the molding hole 331 and the panel 33 are covered, then scrape the base material liquid along the top of the panel 33 .
  • the base material liquid in the molding hole 331 is dried to become the base layer 11
  • the base material liquid in the needle seat groove 3214 is dried to become the needle seat 126
  • the base material liquid in the middle groove 3213 is dried to become the middle part 125 .
  • the isolation part 322 located at the top of the mold 32 blocks the base raw material liquid.
  • the molded base layer 11 forms a gap at the position corresponding to the isolation part 322, that is, at the connection between the first side wall 121 and the second side wall 122 and the base layer.
  • a gap 111 is formed between 11.
  • A5 Remove the panel 33 and separate the microneedles 12 from the molding groove 321.
  • step A1 also includes:
  • the drug-carrying raw material solution includes sodium hyaluronate solution, active ingredients and water.
  • the sodium hyaluronate solution contains 5% to 50% of sodium hyaluronate solution with a molecular weight of 30,000 to 300,000, and 1% to 20% of sodium hyaluronate solution with a molecular weight of less than or equal to 10,000.
  • the proportion of active ingredients is 1% to 20% of the drug carrier liquid.
  • the proportion of water is 50% to 80% of the drug-carrying liquid.
  • the solid content of the drug-carrying liquid is 20% to 60%.
  • the drug-carrying raw material solution includes sodium hyaluronate solution and oil-soluble drug active ingredient solution.
  • the density of the oil-soluble pharmaceutical active ingredient solution is greater than 1 and is similar to the density of the sodium hyaluronate solution. Since the density of the oil-soluble pharmaceutical active ingredient solution and the sodium hyaluronate solution are similar, the oil-soluble pharmaceutical active ingredient can be stably suspended in the sodium hyaluronate solution and will not sink or float during the drying process of the drug-carrying solution, ensuring that the drug-carrying liquid is dried. After the medicinal solution is dried, the oil-soluble pharmaceutical active ingredients can be stably distributed in the sodium hyaluronate. Sodium hyaluronan can also be replaced with other soluble microneedle framework materials.
  • the drug-loaded raw material liquid includes component liquid and 2% calcium chloride ethanol solution.
  • the component liquid includes: 15% sodium alginate, 10% polyvinyl alcohol and 75% water.
  • 2% calcium chloride ethanol solution includes 2% calcium chloride and 98% absolute ethanol.
  • planar microneedles 1 After the planar microneedles 1 are formed, place the planar microneedles 1 in a 2% calcium chloride ethanol solution and soak it for 1 to 2 minutes, so that sodium alginate and calcium chloride undergo a chemical reaction to obtain sodium calcium alginate and alginic acid.
  • Sodium calcium is insoluble in water and human tissue fluid and can be used for tissue fluid extraction and detection. Subsequently, it was dried in a blast drying oven at 35°C for 20 to 30 minutes.
  • step A4 also includes:
  • the drug-loaded liquid is scraped along the needle tip groove 3212 of the mold 32 toward the needle seat groove 1214. Since the depth of the needle tip groove 3212 gradually increases toward the needle seat groove 1214, When the drug-carrying liquid is scraped along this direction, as the raw material liquid fills the molding groove 321, the gas in the molding groove 321 is discharged along the needle tip groove 3212 toward the needle base groove 1214, so as to prevent the molded microneedle 12 from being The presence of air bubbles ensures that the drug loading amount of the microneedle 12 is accurate and the strength meets the requirements.
  • the raw material liquid into the molding holes 331 of the panel 33 until the molding holes 331 are covered, scrape the raw material liquid along the top of the panel 33, place it in a vacuum box, and evacuate it for 2 minutes in a vacuum environment of -0.2Mpa.
  • the gas in the raw material liquid in the molding tank 321 is discharged to avoid the presence of air bubbles in the microneedles 12 after molding.
  • the vacuuming process requires low power and a short time, which can save energy, shorten the molding time of the microneedles 12, and improve production efficiency.
  • step A4 also includes:
  • the raw material liquid After injecting the raw material liquid into the forming hole 331 of the panel 33, it is dried in an environment of 25%-30% relative humidity for 20-30 minutes to achieve the first stage of rapid drying, and then dried in an environment of 40%-60% relative humidity. Dry in an environment for 10-30 minutes to achieve the second stage of slow drying.
  • the drying method that combines fast drying and slow drying can avoid the flat microneedles 7 from curling or deforming during the drying process, thereby ensuring the flat microneedle
  • the quality of the finished product of the needle 1 can be shortened, the drying time of the planar microneedle 1 can be shortened, the production cycle of the planar microneedle 1 can be improved, the production efficiency of the planar microneedle 1 can be improved, and the production cost can be reduced.
  • planar microneedles 1 After injecting the raw material liquid into the forming hole 331 of the panel 33, it is slowly dried overnight in a drying oven with a relative humidity of 25%-60% to ensure that the planar microneedles 1 do not curl or deform during the drying process, thereby ensuring Finished product quality of planar microneedles 1.
  • step A5 also includes:
  • the panel 33 is removed, and vacuum adsorption is used to apply upward suction to the base layer 11 to quickly separate the base layer 11 from the mold 32, thereby achieving separation of the microneedle 12 and the molding groove 321 of the mold 32, and forming.
  • vacuum adsorption is used to apply upward suction to the base layer 11 to quickly separate the base layer 11 from the mold 32, thereby achieving separation of the microneedle 12 and the molding groove 321 of the mold 32, and forming.
  • the panel 33 is removed, and the base layer 11 is lifted up along the direction of the needle seat 126 of the microneedle 12 toward the needle tip 124 to separate the microneedle 12 from the molding groove 321 and form the microneedle patch 2 .
  • the base layer 11 is lifted up along the needle base 126 of the microneedle 12 toward the needle tip 124 , that is, the force is exerted by the connection between the first side wall 121 and the third side wall 123 of the microneedle 12 and the base layer 11
  • the microneedle 12 is driven to separate from the molding groove 321 to avoid the breakage of the connection between the first side wall 121 and the third sidewall 123 of the microneedle 12 and the base layer 11, resulting in the separation of the microneedle 12 and the base layer 11 and the occurrence of defective products.
  • the yield rate of the planar microneedle 1 In order to improve the yield rate of the planar microneedle 1 and reduce the production cost of the planar microneedle 1 .
  • the above preparation method is simple to operate and highly efficient.
  • the drug-loaded raw material liquid and the base raw material liquid can be injected by means of high-pressure spraying, vacuum suction, or centrifugation.
  • this embodiment also provides a planar microneedle vertical device for applying pressure to the microneedles 12 of the planar microneedle 1, so that the microneedles 12 are wound around the second One side 1231 is turned over and passes through the gap 111, and is turned over from the first side wall 121 of the microneedle 12 and the base layer 11 being on the same plane to the third side wall 123 being substantially on the same plane as the base layer 11 or partially abutting the base layer. 11.
  • the angle between the third side wall 123 and the plane of the basal layer 11 is 0° to ⁇ 10° to complete the erect shape of the microneedle 12.
  • the junction between the microneedle 12 and the basal layer 11 forms Base via hole 112.
  • planar microneedle vertical device includes a planar microneedle transmission component 41 and a planar microneedle turning component 42 .
  • the planar microneedle transfer assembly 41 is used to transfer the planar microneedle 1 to the planar microneedle turning assembly 42, and the planar microneedle turning assembly 42 is used to erect the microneedle 12.
  • the planar microneedle transport assembly 41 includes a planar microneedle conveyor belt 4111, a stocker 412, and a planar microneedle absorber 413.
  • the stocker 412 is used to store planar microneedles 1, and a plurality of planar microneedles 1 are stacked one above another.
  • the planar microneedle conveyor belt 4111 is located below the stocker 412, and the planar microneedle adsorber 413 is arranged on the planar microneedle conveyor belt 4111.
  • the planar microneedle adsorber 413 is used to adsorb the planar microneedles 1 to the planar microneedle conveyor belt 4111 one by one.
  • the planar microneedle conveyor belt 4111 is used to convey the planar microneedle 1 to the planar microneedle turning assembly 42.
  • the bottom of the stocker 412 is provided with a discharge port 4121 for discharging the planar microneedles 1 .
  • the discharge port 4121 is specifically: similar in shape to the planar microneedle 1 and smaller in area than the planar microneedle 1 to store the planar microneedle 1 .
  • the discharge port 4121 is arranged parallel to the planar microneedle conveyor belt 4111, and the distance between the discharge port 4121 and the planar microneedle conveyor belt 4111 is greater than the thickness of the planar microneedle 1.
  • the planar microneedle absorber 413 is disposed through the planar microneedle conveyor belt 4111 .
  • the planar microneedle absorber 413 can move along its axial direction and can discharge pulsed negative pressure airflow to adsorb the planar microneedles 1 from the discharge port 4121 and spread them onto the planar microneedle conveyor belt 4111 layer by layer.
  • the planar microneedle adsorber 413 moves upward along its axis and is close to the bottom of the stocker 412, and discharges a pulsed negative pressure airflow.
  • planar microneedle absorber 413 moves downward along its axis and returns to the bottom of the planar microneedle conveyor belt 4111 to transfer the planar microneedle 1 to the planar microneedle conveyor belt 4111 .
  • the planar microneedle absorber 413 is located below the center of the planar microneedle 1 in the stocker 412, so that the adsorption force discharged by the planar microneedle adsorber 413 acts on the center of the planar microneedle 1.
  • the planar microneedle absorber 413 When the planar microneedle absorber 413 When the needle 1 is deformed and discharged from the discharge port 4121, the center of the planar microneedle 1 is first attached to the planar microneedle absorber 413. Then, the adsorption force forms a pulling force on the edge of the planar microneedle 1.
  • planar microneedle 1 With the pulling force Under the action, the edge of the planar microneedle 1 is extended and laid flat on the planar microneedle conveyor belt 4111, so that the planar microneedle 1 is moved from the stocker 412 and laid flat on the planar microneedle conveyor belt 4111.
  • baffles 414 are provided on both sides of the planar microneedle conveyor belt 4111.
  • the baffles 414 can guide the movement of the planar microneedle 1.
  • the planar microneedle flipping assembly 42 includes a flipping mechanism and a microneedle receiving mechanism 422.
  • the flipping mechanism is used to flip the microneedle 12 from the first side wall 121 of the microneedle 12 and the base layer 11 to the third side wall 123. It is substantially on the same plane as the base layer 11 or partially abuts against the base layer 11 to complete the erect shape of the microneedle 12 .
  • a receiving groove 4221 is provided on the top of the microneedle receiving mechanism 422, and the microneedle 12 after erecting is located in the receiving groove 4221.
  • the top wall 4225 at the top of the microneedle accommodating mechanism 422 can support the base layer 11, and the side walls of the accommodating groove 4221 can support the microneedle 12 to prevent the microneedle 12 from being erected when the flipping mechanism applies pressure to the flat microneedle 1.
  • the basal layer 11 and the microneedles 12 are damaged.
  • the flipping mechanism is arranged on the frame (not shown in the drawings), and the microneedle accommodating mechanism 422 is arranged on a vertical conveyor belt 4112 (not shown in the accompanying drawings).
  • the vertical conveyor belt 4112 is used to drive the microneedle accommodating mechanism 422 Move horizontally.
  • the length of the receiving groove 4221 is greater than the height from the tip 124 of the microneedle 12 to the needle seat 126 to prevent the microneedle 12 from colliding with the receiving groove 4221 and causing damage during the erection process, thereby ensuring the yield rate of the microneedle 12 after erecting.
  • the depth of the receiving groove 4221 is greater than the height from the needle tip 124 of the microneedle 12 to the needle seat 126, so as to prevent the microneedle 12 from being damaged by colliding with the bottom of the receiving groove 4221 when it is accommodated in the receiving groove 4221, thus ensuring that the microneedle 12 is standing upright. Yield rate after shaping.
  • the length and depth of the receiving groove 4221 are both greater than the height from the needle tip 124 of the microneedle 12 to the needle seat 126, when the flat microneedle 1 is transformed into the microneedle patch 2, the microneedle 12 can be easily separated from the receiving groove 4221.
  • multiple receiving grooves 4221 are provided, and the multiple receiving grooves 4221 are arranged at intervals on the top of the microneedle receiving mechanism 422 , and the multiple receiving grooves 4221 are arranged in one-to-one correspondence with the multiple rows of microneedles 12 on the planar microneedle 1 .
  • the microneedle accommodating mechanism 422 is preferably made of elastic material, such as silicone and rubber, so that the top wall 4225 at the top of the microneedle accommodating mechanism 422 can provide elastic support for the base layer 11 and the side walls of the accommodating groove 4221 can provide elasticity for the microneedle 12 support.
  • the flipping mechanism applies pressure to the planar microneedle 1, the top wall 4225 of the microneedle accommodating mechanism 422 and the base layer 11 are pressed simultaneously.
  • the top wall 4225 can provide a reaction force to support the base layer 11, and the top wall 4225 can As the base layer 11 elastically deforms, to avoid damage to the base layer 11, the side walls of the accommodation groove 4221 can provide a reaction force to support the microneedles 12, and the side walls of the accommodation groove 4221 can elastically deform along with the microneedles 12 when pressed. Avoid damage to the microneedles 12.
  • the end of the microneedle accommodating mechanism 422 away from the planar microneedle conveyor belt 4111 is provided with a limit plate 4224.
  • the limit plate 4224 can move up and down.
  • the turning mechanism includes a pressure plate 4211, or the turning mechanism includes a first roller 4212, or the turning mechanism includes a roller assembly.
  • the pressing plate 4211 is made of elastic material, and the pressing plate 4211 can flip all the microneedles 12 of the planar microneedle 1 to the upright shape at the same time, thereby improving the upright shape efficiency.
  • the pressure plate 4211 is installed on the frame (not shown).
  • the pressure plate 4211 has a uniform thickness in the vertical direction.
  • the pressure plate 4211 can move downward in the vertical direction relative to the frame to contact the third side wall 123 of the microneedle 12 and move toward the third side wall 123 of the microneedle 12 .
  • the three side walls 123 exert pressure to rotate the microneedle 12 around the first side 1231 until the third side wall 123 and the base layer 11 are approximately on the same plane or partially abut against the base layer 11 , that is, where the third side wall 123 and the base layer 11 are located.
  • the angle between the planes is 0° to ⁇ 10°, completing the vertical shape of the flat microneedle 1.
  • the pressure plate 4211 is installed on a frame (not shown), and the side of the pressure plate 4211 away from the planar microneedle 1 is connected to the frame through an elastic mechanism (not shown) such as a spring.
  • the pressure plate 4211 can be positioned vertically relative to the frame. move.
  • the pressing plate 4211 is a wedge-shaped body. Along the vertical direction, the cross section of the pressing plate 4211 is triangular or trapezoidal.
  • the extension direction of the wedge-shaped pressing plate 4211 is consistent with the direction in which the needle seat 126 of the microneedle 12 of the planar microneedle 1 points to the needle tip 124, that is, when the third side wall 123 of the microneedle 12 is disposed facing away from the planar microneedle conveyor belt 4111, the pressing plate
  • the thickness of the end of 4211 away from the planar microneedle conveyor belt 4111 is greater than the thickness of the end close to the planar microneedle conveyor belt 4111.
  • the microneedle 12 When the pressure plate 4211 moves downward to press against the planar microneedle 1, the microneedle 12 is under the action of the wedge-shaped pressure plate 4211, and the third side wall 123 of the microneedle 12 comes into contact with the inclined surface of the wedge-shaped pressure plate 4211 to form a contact point.
  • the pressure plate 4211 gives the third side wall 123 a component force directed from the contact point to the needle tip 124, thereby causing the microneedle 12 to rotate around the first side 1231.
  • the third side wall 123 receives the horizontal component force and the vertical downward component force of the pressing plate 4211, so that the microneedle 12 continues to rotate around the first side 1231 until the third side wall 123 It is roughly on the same plane as the base layer 11 or partially abuts the base layer 11 , that is, the angle between the third side wall 123 and the plane of the base layer 11 is 0° to ⁇ 10°, thus completing the erect shape of the planar microneedle 1 .
  • the side of the pressure plate 4211 away from the planar microneedle 1 is connected to the frame through an elastic mechanism such as a spring, when the wedge-shaped pressure plate 4211 presses down the planar microneedle 1, the pressure between the pressure plate 4211 and the planar microneedle 1 can be adjusted by the spring mechanism. , thereby preventing the planar microneedle 1 from deforming due to excessive pressure and causing defective products.
  • an elastic mechanism such as a spring
  • the pressure plate 4211 is installed on a frame (not shown).
  • the pressure plate 4211 has a uniform thickness in the vertical direction and can move in an oblique downward direction relative to the frame. That is, the pressure plate 4211 moves from the third side relative to the planar microneedle 1.
  • the contact point between the wall 123 and the pressure plate 4211 moves downward in an inclined direction toward the needle tip 124, with an inclination angle of 30° ⁇ 60° relative to the horizontal direction.
  • the pressure plate 4211 moves obliquely downward along the direction where the contact point between the third side wall 123 and the pressure plate 4211 points to the needle tip 124.
  • the third side wall 123 When the pressure plate 4211 contacts the third side wall 123 to form a contact point and exerts pressure on the third side wall 123, the third side wall 123 is pressed.
  • the side wall 123 has a component force directed from the contact point to the needle tip 124, thereby causing the microneedle 12 to rotate around the edge 1231.
  • the third side wall 123 receives the horizontal component force and the vertical downward component force of the pressing plate 4211, so that the microneedle 12 continues to rotate around the first side 1231 until the third side wall 123 It is roughly on the same plane as the base layer 11 or partially abuts the base layer 11 , that is, the angle between the third side wall 123 and the plane of the base layer 11 is 0° to ⁇ 10°, thus completing the erect shape of the planar microneedle 1 . When ⁇ 30°, the pressure plate 4211 needs to move a larger distance when it moves down to contact the microneedle 12.
  • the area of the pressure plate 4211 is basically the same as that of the planar microneedle 1, then when the pressure plate 4211 is completely pressed to the surface of the planar microneedle 1 When the basal layer 11 is on the surface, part of the microneedles 12 is located outside the pressure plate 4211, and the pressure plate 4211 cannot contact and pressurize this part of the microneedles 12, and cannot completely complete the vertical shape; if the area of the pressure plate 4211 is much larger than the flat microneedle 1, it can be achieved All the microneedles 12 on the planar microneedles 1 are vertical, but the number of planar microneedles 1 placed on the same length of assembly line is relatively reduced, which reduces production efficiency and indirectly increases production costs.
  • multiple pressure portions 42111 are provided at the bottom of the pressure plate 4211, and the pressure portions 42111 and the accommodation grooves 4221 are provided in one-to-one correspondence.
  • the longitudinal cross-section of the pressing portion 42111 is a downwardly protruding arc, V-shape, rectangle, or other shape that can pressurize the microneedle 12 .
  • the longitudinal section of the pressing part 42111 is preferably a downwardly protruding arc or V-shape, so that when the pressing part 42111 presses the microneedle 12, the shape of the pressing part 42111 and the third side wall 123 of the microneedle 12 The shapes after deformation under pressure match, so that the third side wall 123 of the microneedle 12 is evenly stressed, thereby preventing the microneedle 12 from being damaged.
  • the material of the pressure plate 4211 and the pressure portion 42111 is preferably an elastic material, such as rubber or silicone, so that when the pressure plate 4211 or the pressure portion 42111 presses the microneedle 12, The pressure plate 4211 or the pressure portion 42111 can deform and fall into the receiving groove 4221 to provide sufficient turning pressure for the microneedle 12 to turn the microneedle 12 from the same plane as the first side wall 121 and the base layer 11 to the third side.
  • the wall 123 is inclined to the side of the base layer 11 close to the microneedle 12, and after the microneedle 12 rebounds, the third side wall 123 of the microneedle 12 can be approximately on the same plane as the base layer 11 or partially abut against the base layer 11. That is, the angle between the third side wall 123 and the plane of the base layer 11 is 0° to ⁇ 10°, thereby completing the upright shape of the microneedle 12 .
  • the material of the pressing plate 4211 or the pressing part 42111 is not limited, and can be a rigid material or an elastic material, which reduces the difficulty of material selection of the pressing plate 4211 and the pressing part 42111.
  • the microneedle accommodating mechanism 422 preferably also includes a plurality of sets of fixed plate assemblies arranged at intervals.
  • the fixed plate assembly is used to prevent the pressure plate 4211 from resetting and leaving and no longer pressing the flat microneedle 1.
  • the microneedle 12 rotates around the first side 1231 in the opposite direction of the vertical shape without external force, causing the third side wall 123 to be in contact with the base.
  • the bottom layer 11 forms a certain angle.
  • Each fixed plate assembly includes a first clamping plate 4222 and a second clamping plate 4223.
  • the first clamping plate 4222 can move closer to or away from the second clamping plate 4223 in a direction parallel to the base layer 11 .
  • a receiving groove 4221 is formed between the first clamping plate 4222 and the second clamping plate 4223.
  • the first clamping plate 4222 is away from the second clamping plate 4223 of the same set of fixed plate components, and an accommodating groove 4221 is formed between the first clamping plate 4222 and the second clamping plate 4223.
  • the accommodating groove 4221 is The space is large, and the microneedle 12 can rotate freely in the receiving groove 4221 without being blocked by the first clamping plate 4222.
  • the flat microneedle conveyor belt 4111 transports the flat microneedle 1 to the top of the microneedle accommodating mechanism 422, and makes the multiple rows of microneedles 12 on the flat microneedle 1 correspond to the multiple accommodation slots 4221 on the top of the microneedle accommodating mechanism 422. place setting.
  • the pressure plate 4211 exerts pressure on all the microneedles 12 on the planar microneedles 1.
  • the microneedles 12 are turned from the first side wall 121 of the microneedles 12 and the base layer 11 on the same plane to the third side wall 123 of the microneedles 12 and the base layer. 11 is generally on the same plane or partially abuts the base layer 11 , that is, the angle between the third side wall 123 and the plane of the base layer 11 is 0° to ⁇ 10°.
  • the microneedle 12 is located in the receiving groove 4221 .
  • the plurality of first clamping plates 4222 synchronously move to the right and form an accommodating groove 4221 with a space equal to or slightly larger than the space occupied by the microneedle 12 between the second clamping plate 4223, so that the microneedle 12 is located in the accommodating groove 4221 and is protected.
  • the first clamping plate 4222 blocks the rotation around the first side 1231 in the opposite direction of the upright shape.
  • the microneedle 12 can still keep the third side wall 123 and the base layer 11 substantially on the same plane or partially abut the base layer 11, that is, the third side wall 123 and the base layer
  • the included angle between the planes of the bottom layer 11 is 0° to ⁇ 10°, which prevents the microneedle 12 from being displaced when adhering to the adhesive layer 21, resulting in weak adhesion or wrinkling of the adhesive layer 21.
  • a driving structure is provided on the microneedle accommodating mechanism 422, and the driving structure is used to drive the first clamping plate 4222 to move.
  • the flipping mechanism includes a first roller 4212
  • the first roller 4212 is pressed on the planar microneedle 1, and the first roller 4212 is used to press the microneedle 12, so that the microneedle 12 is
  • the first side wall 121 of the microneedle 12 is on the same plane as the base layer 11 and the third side wall 123 is substantially on the same plane as the base layer 11 or partially abuts the base layer 11 , that is, where the third side wall 123 and the base layer 11 are.
  • the angle between the planes is 0° to ⁇ 10°, and the 12-dimensional microneedle is completed. At this time:
  • the first roller 4212 and the microneedle accommodating mechanism 422 can move toward each other. Specifically, the first roller 4212 rotates around the fixed axis of the first roller 4212, and the microneedle accommodating mechanism 422 moves along the vertical conveyor belt 4112 (not shown) away from the plane.
  • the needle conveyor belt 4111 moves in the direction; or the microneedle accommodating mechanism 422 is fixed, and the first roller 4212 rolls around the support axis of the first roller 4212 relative to the microneedle accommodating mechanism 422; or the microneedle accommodating mechanism 422 moves along with the vertical conveyor belt 4112 (not shown). (shown) moves in a direction away from the planar microneedle conveyor belt 4111, the first roller 4212 rolls around the support axis of the first roller 4212 and moves horizontally in a direction close to the planar microneedle conveyor belt 4111.
  • the first roller 4212 rolls around the fixed axis of the first roller 4212, and the microneedle accommodating mechanism 422 moves horizontally with the vertical conveyor belt (not shown) in a direction away from the flat microneedle conveyor belt 4111, reducing the relative moving elements and simplifying the equipment. Control elements and simplify processes.
  • the first roller 4212 is located on the opposite side to the third side wall 123 of the microneedle 12 of the planar microneedle 1, and the microneedle accommodating mechanism 422 moves along with the vertical conveyor belt (not shown) in a direction away from the planar microneedle conveyor belt 4111.
  • the first roller 4212 rotates in the counterclockwise direction, and the surface of the first roller 4212 is pressed against the third side wall 123, giving the third side wall 123 a component force in the horizontal direction toward the planar microneedle conveyor belt 4111 and a component force vertically downward.
  • the force causes the microneedle 12 to rotate around the first side 1231 until the third side wall 123 and the base layer 11 are approximately in the same plane or partially against the base layer 11 , that is, the angle between the third side wall 123 and the plane of the base layer 11 is 0. ° ⁇ 10°, complete the vertical shape of the planar microneedle 1.
  • the first roller 4212 presses the microneedles 12 row by row, so that the microneedles 12 stand upright row by row.
  • the rotation direction of the first roller 4212 is the same as the rotation direction of the microneedle 12, the pressing force of the third side wall 123 of the microneedle 12 by the first roller 4212 is converted into a force to rotate the microneedle 12, thereby preventing the microneedle 12 from rotating. It will not be damaged due to force during the erection process to ensure the yield rate of the product.
  • the flipping mechanism also includes a roller assembly.
  • the roller assembly is arranged on the frame (not shown).
  • the roller assembly includes The second roller 4213 and the third roller 4214.
  • the adhesive layer 21 is wound around the second roller 4213 , and the second roller 4213 is used to transfer the adhesive layer 21 to the first roller 4212 .
  • the side of the adhesive layer 21 provided with the protective film faces away from the rotating axes of the first roller 4212 and the second roller 4213 .
  • the first roller 4212 is provided with a protective film peeling structure on the side close to the third roller 4214.
  • the protective film peeling structure is used to control the peeling position of the protective film peeled off from the adhesive layer 21.
  • the third roller 4214 is used to wrap and store the protective film peeled off by the first roller.
  • 4212 is a protective film obtained by removing the adhesive layer 21. This protective film is used to prevent the adhesive layer 21 from sticking to each other when being wound around, rendering it unusable.
  • the first roller 4212 is used to press the microneedle 12 so that the microneedle 12 is turned over from the first side wall 121 of the microneedle 12 and the base layer 11 being on the same plane to the third side wall 123 and the base layer 11 being substantially on the same plane. Or it partially abuts the base layer 11 , that is, the angle between the third side wall 123 and the plane of the base layer 11 is 0° to ⁇ 10° to complete the upright shape of the microneedle 12 .
  • the first roller 4212 can also push the adhesive layer 21 Adhere to the side of the base layer 11 away from the microneedle 12 and the third side wall 123 or the protruding portion 127 of the microneedle 12 to prepare the microneedle patch 2 provided with the adhesive layer 21 .
  • the microneedle accommodating mechanism 422 can drive the planar microneedle 1 to move in a direction away from the planar microneedle conveyor belt 4111 .
  • the first roller 4212 and the microneedle accommodating mechanism 422 can move toward each other to realize the erection of the microneedles 12 row by row, and adhere the adhesive layer 21 row by row to the side of the base layer 11 away from the microneedle 12 and the third side of the microneedle 12
  • the microneedle patch 2 provided with the adhesive layer 21 is formed on the side wall 123 or the protruding portion 127 .
  • the adhesive layer 21 can adhere to the base layer 11 and the third side wall 123 or the convex portion 127 of the microneedle 12 row by row to completely discharge the base layer 11 and the adhesive layer 21 and the third side wall 123 of the microneedle 12 .
  • the air between the three side walls 123 or the raised portion 127 and the adhesive layer 21 prevents the formed microneedle patch 2 from wrinkling.
  • the third side wall 123 or the protruding portion 127 of the microneedle 12 adheres to the adhesive layer 21, it is pulled by the adhesive force between the base layer 11 and the adhesive layer 21 and the third side wall of the microneedle 12.
  • the adhesive layer 21 at the contact point 123 or the protruding portion 127 is smooth and wrinkle-free, which improves the yield rate of the formed microneedle patch 2 .
  • the first roller 4212 is preferably made of elastic material, such as rubber or silicone, so that when the first roller 4212 presses the microneedles 12, the first roller 4212 can deform and fall into the receiving groove 4221, providing sufficient space for the microneedles 12.
  • the flipping pressure is to flip the microneedle 12 from the first side wall 121 of the microneedle 12 and the base layer 11 on the same plane to the third side wall 123 of the microneedle 12 that is inclined to the side of the base layer 11 close to the microneedle 12, Furthermore, after the microneedle 12 rebounds, the third side wall 123 of the microneedle 12 is approximately on the same plane as the base layer 11 or partially abuts the base layer 11 , that is, the angle between the third side wall 123 and the plane of the base layer 11 It is 0° ⁇ 10°, and the microneedle has 12 vertical shapes.
  • the vertical device of the planar microneedle also includes an adhesive layer sticking mechanism.
  • the adhesive layer application mechanism includes a gripper and a visual identifier. After the microneedle 12 is erect, the flipping mechanism is moved away, and the grabber uses the visual identifier to correspondingly attach the adhesive layer 21 to the side of the base layer 11 away from the microneedle 12 . Subsequently, the flipping mechanism applies pressure to the adhesive layer 21 to stably adhere the adhesive layer 21 to the side of the base layer 11 away from the microneedle 12 and the third side wall 123 or the protruding portion 127 of the microneedle 12 to form a shape of Microneedle patch 2 provided with adhesive layer 21 .
  • the gripping element is preferably a vacuum suction gripping device.
  • the adhesive layer pasting mechanism also includes an adhesive layer conveyor and a temporary storage station.
  • the adhesive layer conveyor is used to remove the protective film on the adhesive layer 21 and transfer the adhesive layer 21 to the temporary storage station.
  • the adhesive layer 21 is stored and provided for the gripper to grip one by one.
  • the protective film is used to prevent the adhesive layer 21 from sticking.
  • this embodiment also provides another planar microneedle erecting device for adhering the planar microneedle 1 to the adhesive layer 21 for shaping. Patches 2 for Microneedle.
  • the planar microneedle upright device includes a planar microneedle transmission component 41 and a planar microneedle turning component 42 .
  • the planar microneedle transport assembly 41 is used to transport the planar microneedles 1 and the adhesive layer 21 .
  • the planar microneedle turning component 42 is located at the connection between the planar microneedle 1 and the adhesive layer 21 .
  • the planar microneedle flipping assembly 42 is used to adhere the base layer 11 to the adhesive layer 21 and flip the first side wall 121 where the microneedle 12 and the base layer 11 are on the same plane to the third side wall 123 and the base layer 11 are approximately On the same plane or partially against the base layer 11, the third side wall 123 is adhered to the adhesive layer 21 to complete the microneedle erection.
  • the planar microneedle conveying assembly 41 includes a planar microneedle conveying belt 4111 and a vertical conveying belt 4112.
  • the planar microneedle conveyor belt 4111 is arranged at an angle and is used to convey the planar microneedle 1.
  • the vertical conveyor belt 4112 is arranged horizontally and is located at the lower end of the planar microneedle conveyor belt 4111.
  • the vertical conveyor belt 4112 is used to convey the sticky adhesive layer 21 and accept the planar microneedles 1 from the planar microneedle conveyor belt 4111.
  • the planar microneedle turning assembly 42 is located near the lower end of the planar microneedle conveyor belt 4111.
  • the inclined planar microneedle conveyor belt 4111 can transport the planar microneedle 1 to the adhesive layer 21 in a manner that gradually contacts the adhesive layer 21 on the upright conveyor belt 4112, so that Make sure that the flat microneedle 1 and the adhesive layer 21 are bonded smoothly, and there are no bubbles or hollow wrinkles between them.
  • the planar microneedle flipping assembly 42 is used to adhere the base layer 11 of the planar microneedle 1 to the adhesive layer 21 and rotate the microneedles 12 of the planar microneedle 1 around the connection between the third side wall 123 and the base layer 11.
  • the first side wall 121 which is on the same plane as the base layer 11 is turned over to the third side wall 123 which is roughly on the same plane as the base layer 11 or partially abuts against the base layer 11 , thereby realizing the upright shape of the microneedle 12 .
  • the microneedle 12 The bottom is adhered to the adhesive layer 21, and the planar microneedle 1 and the adhesive layer 21 are combined to form a microneedle patch 2.
  • planar microneedle erecting device is suitable for two-step molding of microneedle patches 2.
  • the planar microneedle 1 is formed into a planar microneedle 1 through the microneedle mold 32, and then the planar microneedle erecting device adheres the planar microneedle 1 to the adhesive layer. 21, and adjust the microneedle 12 until the third side wall 123 is substantially on the same plane as the base layer 11 or partially abuts the base layer 11, and then adheres to the adhesive layer 21.
  • planar microneedle flipping assembly 42 applies a force to the planar microneedle 1 to make the planar microneedle 1 adhere to the adhesive layer 21 , and the direction of the force is preferably perpendicular to the conveying direction of the vertical conveyor belt 4112 .
  • the force exerted by the planar microneedle turning component 42 to the planar microneedle 1 acts on the planar microneedle 1 row by row/step by step, so that the base layer 11 of the planar microneedle 1 adheres to the adhesive layer 21 row by row.
  • the microneedles 12 on the planar microneedle 1 receive a reaction force from the adhesive layer 21.
  • each row of microneedles 12 The third side wall 123 can be rotated around the respective connections with the base layer 11 at the same time, so that the first side wall 121 located on the same plane as the base layer 11 can be turned over to the third side wall 123 and the base layer 11 to be substantially on the same plane or part of the base layer 11 . It abuts the base layer 11 and makes the third side wall 123 adhere to the adhesive layer 21 to complete the erection of the microneedle.
  • the third side wall 123 of the microneedle 12 is adhered to the adhesive layer 21 , so that the planar microneedle 1 and the adhesive layer 21 are combined into the microneedle patch 2 .
  • the base layer 11 and the adhesive layer 21 are contacted row by row to gradually realize the combination of the base layer 11 and the adhesive layer 21, which can completely discharge the air between the base layer 11 and the adhesive layer 21.
  • Due to the planar microneedle conveyor belt 4111 has a certain angle with the vertical conveyor belt 4112.
  • the size of the third side wall 123 of the microneedle 12 is similar to the size projected on the adhesive layer 21, and the third side wall 123 of the microneedle 12 is bonded to the adhesive layer 21 layer by layer.
  • the difference between the size L1 of the third side wall 123 of the microneedle 12 and its projected size L2 on the adhesive layer 21 is small, and both the base layer 11 and the adhesive layer 21 have a certain elasticity, so it can avoid all the problems when the microneedle 12 is upright.
  • the third side wall 123 of the microneedle 12 and the adhesive layer 21 are bonded at the same time and the difference in size difference accumulates, causing the formed microneedle patch 2 to wrinkle.
  • the microneedle 12 rotates until the third side wall 123 adheres to the adhesive layer 21 , under the pulling force of the adhesive force between the base layer 11 and the adhesive layer 21 , the microneedle 12 can make contact with the third side wall 123 of the microneedle 12 .
  • the adhesive layer 21 is smooth and wrinkle-free to improve the yield rate of the formed microneedle patch 2 .
  • At least one planar microneedle turning component 42 is arranged at intervals, so that after the planar microneedle turning component 42 close to the planar microneedle conveying belt 4111 adheres the planar microneedle 1 to the adhesive layer 21 , the remaining planar microneedle turning components 42 can continuously apply force to the microneedle patch 2 to make the combination between the planar microneedle 1 and the adhesive layer 21 stronger.
  • planar microneedle flipping component 42 can be of the following types:
  • the planar microneedle turning component 42 may be a vacuum negative pressure adsorption adhesive component 423 .
  • the vacuum negative pressure adsorption adhesive member 423 is provided below the vertical conveyor belt 4112.
  • the vacuum negative pressure adsorption adhesive member 423 is used to apply a negative pressure airflow perpendicular to the conveying direction of the vertical conveyor belt 4112 to the planar microneedle 1. Under the adsorption force of the negative pressure airflow, the planar microneedle 1 adheres to the adhesive layer 21 to Shaped into microneedle patch 2.
  • the vertical conveyor belt 4112 and the adhesive layer 21 are both provided with grid-shaped through holes for air flow to pass through.
  • the planar microneedle turning component 42 may be an air pressure adhesive component 424 .
  • the air pressure adhesive member 424 is disposed above the vertical conveyor belt 4112.
  • the air pressure adhesive member 424 can apply an airflow perpendicular to the conveying direction of the vertical conveyor belt 4112 to the planar microneedle 1. Under the adhesion pressure of the airflow, the planar microneedle 1 adheres to the adhesive layer 21 to form a microneedle patch 2 .
  • the vertical conveyor belt 4112 may be a mesh-shaped plane or a non-porous plane, and the adhesive layer 21 may be a non-porous plane.
  • the planar microneedle turning component 42 may be a roller contact pressing member 425 .
  • the roller contact pressing member 425 includes at least one roller 4251 arranged at intervals.
  • the axial direction of the at least one roller 4251 is perpendicular to the transport direction of the vertical conveyor belt 4112, and each roller 4251 is used to roll each row of micro-needle 1 arranged on the plane.
  • pressure is applied to the base layer 11 step by step/row by row, and the adhesive layer 21 forms a reaction force for applying to the microneedles 12 step by step/row by row.
  • the planar microneedles 1 are adhered to the adhesive layer 21 to form the microneedle patch 2 . Since the pressing area between the roller 4251 and the planar microneedle 1 is small and the pressure is large, the adhesion between the base layer 11 and the bottom of the microneedle 12 and the adhesive layer 21 can be made stronger.
  • the roller contact pressing member 425 also includes a support frame 4252, and the roller 4251 is rotatably installed on the support frame 4252.
  • the angle between the extension direction of the planar microneedle conveyor belt 4111 and the extension direction of the vertical conveyor belt 4112 is 135°-179°.
  • the angle between the extension direction of the planar microneedle conveyor belt 4111 and the extension direction of the vertical conveyor belt 4112 is less than 135°, it is easy to cause the planar microneedle 1 to adhere to the adhesive layer 21, and the gap between the planar microneedle 1 and the adhesive layer 21
  • the included angle is too large, causing the force of the airflow exerted by the vacuum negative pressure adsorption adhesive member 423 and the wind pressure adhesive member 424 on the planar microneedle 1 to act on the planar microneedle 1 to be decomposed into an increasing horizontal component force parallel to the adhesive layer 21.
  • the vertical component force perpendicular to the adhesive layer 21 decreases, resulting in: the base layer 11 of the planar microneedle 1 cannot be pressed to the surface of the adhesive layer 21, the base layer 11 and the adhesive layer 21 cannot fit together, or the base layer 11 cannot be adhered to the adhesive layer 21.
  • the adhesion force between the base layer 11 and the adhesive layer 21 is insufficient, and the base layer 11 and the adhesive layer 21 cannot achieve complete adhesion. Due to insufficient vertical component force acting on the planar microneedle 1, the base layer 11 and the adhesive layer 21 cannot adhere or adhere completely.
  • the reaction force generated by the adhesive layer 21 for rotating the microneedle 12 is small, causing the microneedle to rotate. 12 cannot be rotated or cannot be fully rotated.
  • the roller 4251 contacts the planar microneedles 1 that have not been transferred to the vertical shape conveyor belt 4112 and damages the microneedles 12 .
  • the angle between the extension direction of the planar microneedle conveyor belt 4111 and the extension direction of the vertical conveyor belt 4112 is greater than 179°, since the planar microneedle conveyor belt 4111 and the vertical conveyor belt 4112 are almost parallel, when the microneedle 12 is in the upright shape, all microneedle The bottom of the needle 12 is bonded to the adhesive layer 21 at the same time.
  • the cumulative difference L1-L2 between the third side wall size L1 of the multiple microneedle 12 and the size L2 projected on the adhesive layer 21 is larger, resulting in a larger shape after molding.
  • the microneedle patch 2 wrinkled and became a defective product.
  • the lower end of the planar microneedle conveyor belt 4111 is provided with a baffle 414 for the planar microneedle 1 to pass through.
  • the baffle 414 serves as a guide for the transportation of the planar microneedle 1 .
  • the baffle 414 includes a first baffle 4141 and a second baffle 4142. The first baffle 4141 and the second baffle 4142 are disposed oppositely on both sides of the planar microneedle conveyor belt 4111.
  • this planar microneedle vertical device also includes a stocker 412.
  • the stocker 412 is located above the planar microneedle conveyor belt 4111 and at the upper end of the planar microneedle conveyor belt 4111.
  • the stocker 412 is used to store the microneedle stacked up and down. Planar microneedles1.
  • the bottom of the stocker 412 is provided with a discharge port for discharging the planar microneedles 1 .
  • the discharge port is specifically: similar in shape to the planar microneedle 1 and smaller in area than the planar microneedle 1 to store the planar microneedle 1 .
  • the discharge port and the planar microneedle conveyor belt 4111 are arranged in parallel, and the distance between the discharge port and the planar microneedle conveyor belt 4111 is greater than the thickness of the planar microneedle 1 .
  • the present planar microneedle vertical device also includes a planar microneedle absorber 413 .
  • the planar microneedle absorber 413 is disposed through the planar microneedle conveyor belt 4111 , and the planar microneedle absorber 413 is located below the center of the planar microneedle 1 in the stocker 412 .
  • the planar microneedle absorber 413 can discharge pulsed negative pressure airflow to adsorb the planar microneedles 1 from the discharge port layer by layer and lay them flat on the planar microneedle conveyor belt 4111.
  • the planar microneedle adsorber 413 can move in the axial direction.
  • the planar microneedle absorber 413 can pass through the planar microneedle conveyor belt 4111 and be close to the bottom of the stocker 412 to discharge the pulsed negative pressure air flow, when the planar microneedle 1 is sucked out from the stocker 412 onto the planar microneedle conveyor belt 4111 , the planar microneedle absorber 413 stops discharging the pulsed negative pressure airflow, and returns to the bottom of the planar microneedle conveyor belt 4111 along the axis direction.
  • the specific process is as follows:
  • planar microneedle absorber 413 Since the planar microneedle absorber 413 is located below the center of the planar microneedle 1 in the stocker 412, the adsorption force exerted by the planar microneedle adsorber 413 to the planar microneedle 1 acts on the center of the planar microneedle 1. The needle 1 is deformed and discharged from the outlet. The center of the flat microneedle 1 is first attached to the flat microneedle conveyor belt 4111. Then, the adsorption force forms a pulling force at the edge of the flat microneedle 1.
  • planar microneedle erecting device of the present invention has a simple structure and is easy to process, and the erecting method is quick and efficient.
  • the terms “one embodiment”, “some embodiments”, “embodiments”, “examples”, “specific examples” or “some examples”, etc. refer to the description in conjunction with the embodiment or example.
  • a specific feature, structure, material, or characteristic described is included in at least one embodiment or example of the invention.
  • the schematic expressions of the above terms are not necessarily directed to the same embodiment or example.
  • the specific features, structures, materials or characteristics described may be combined in any suitable manner in any one or more embodiments or examples.
  • those skilled in the art may combine and combine different embodiments or examples and features of different embodiments or examples described in this specification unless they are inconsistent with each other.

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Abstract

本发明涉及一种平面微针,包括基底层和微针。微针包括针尖、中部和针座。微针还包括第一侧壁、周向侧壁和第三侧壁,第一侧壁与基底层位于同一平面,第一侧壁和周向侧壁位于微针周向,第三侧壁位于微针底部。第三侧壁包括第一边和活动边,第一边连接基底层。微针绕第一边旋转至第三侧壁与基底层所在平面间的夹角为0°~±10°,且微针与基底层相接处形成基底通孔。本发明还涉及一种微针贴、平面微针的制造设备、平面微针的制备方法和平面微针立形装置。本发明的有益效果是,微针仅在针尖处载药,且适用于向成型槽内灌注油水混合物或黏性较高的原料液,且微针立形后稳定。

Description

一种平面微针、微针贴及制造设备、立形设备和制备方法 技术领域
本发明属于微针技术领域,具体涉及一种平面微针、微针贴及制造设备、立形设备和制备方法。
背景技术
微针贴主要包括基底层和设置于基底层上的微针。使用时,将微针贴设有微针的一侧按压贴附于皮肤上,由于微针的针长较短,使用时满足给药需求且不会造成神经损伤和疼痛,进而逐渐被公众认可。
微针贴主要采用模具成型,在模具的成型槽内采用高压喷射或真空吸入等方式灌注载药液,直接成型出沿垂直于基底层的方向延伸设置的微针。为保证微针贴在使用时,患者能够被注入预设的给药量,微针的针尖处为载药区域。由于用于成型微针的成型槽的深度及深纵比均较大,在喷射灌注载药液时,载药液会以扇形向四周扩散,导致载药液飞溅到成型槽中对应成型微针的中部和针座的位置,亦或采用真空吸入灌注时,载药液经成型槽中对应成型微针的针座和中部位置进入针尖位置,使成型后的微针的针尖、中部和针座均载药。该微针在使用时,随着微针进入皮肤深度的不同,患者注入的给药量也不同,无法控制精确的给药量,且由于成型槽内的载药液难以清除,导致成型槽污染,影响其他批次的微针。进而,由于成型槽的深度及深纵比均较大,导致微针成型后的脱模阻力较大,难以脱模。
因此,目前亟需一种能够使载药液集中在针尖的微针,以及用于成型该微针的制造设备和制备方法。
发明内容
鉴于现有技术的上述缺点、不足,本发明提供一种平面微针、微针贴和立形及制造设备和制备方法,适用于采用两步式成型的微针贴,该成型法先成型出微针的第一侧壁和基底层位于同一平面的平面微针,再由平面微针立形装置将微针调整至微针的第三侧壁与基底层所在平面间的夹角为0°~±10°,并成型为微针贴,其解决了现有的用于成型微针贴的模具难以脱模、微针的针尖处载药精度较低以及难以向成型槽内注入油水混合物原料液或黏性较高原料液的技术问题。
为了实现上述目的,本发明采用以下的技术方案:
一种平面微针,包括基底层和可翻转设置在所述基底层上的微针,所述微针包括针尖、针座和连接所述针尖和所述针座的中部,所述针尖朝向所述针座的方向与所述基底层延伸方向相同。所述平面微针由原料液填充干燥成型。
具体的,所述微针包括第一侧壁、周向侧壁和第三侧壁,所述第一侧壁和所述周向侧壁位于所述微针的周向,所述第三侧壁位于所述微针的底部。所述第一侧壁和所述基底层位于同一平面,所述第三侧壁连接所述基底层,所述微针能够绕所述第三侧壁与所述基底层的连接处翻转。
具体的,所述第三侧壁包括第一边,所述第一边连接所述基底层远离第一侧壁一侧。所述微针可绕所述第一边,以所述第三侧壁朝向所述第一侧壁的方向,旋转至所述第三侧壁与基底层所在平面间的夹角为0°~±10°,所述微针与所述基底层的相接处形成基底通孔。
具体的,所述微针可绕所述第一边旋转至所述第三侧壁部分抵靠在所述基底层靠近所述微针的一侧,第三侧壁包括与所述第一边连接的活动边,所述活动边与所述基底通孔侧壁间的夹角θ的取值范围为0°<θ≤10°。
具体的,所述微针沿垂直于所述基底层的最大深度和沿平行于所述基底层的最大长度的比值为1:5~1:2。
一种微针贴,所述微针贴包括上述的平面微针。
具体的,所述微针贴还包括粘性层。所述微针包括第一侧壁、周向侧壁和第三侧壁,所述第一侧壁和所述周向侧壁位于所述微针的周向,所述第三侧壁位于所述微针的底部。所述第一侧壁和所述基底层位于同一平面,所述第三侧壁连接所述基底层,所述微针能够绕所述第三侧壁与所述基底层的连接处翻转,使所述微针和所述基底层远离所述微针的一侧均粘附于所述粘性层。
一种平面微针制造设备,应用于制造上述的平面微针,包括底座、模具和位于所述底座上方的面板。
所述底座的顶部设置用于容纳所述模具的凹槽。
所述模具的顶部设置多个内凹用于成型微针的成型槽。
所述成型槽包括针尖槽、针座槽和中部槽,所述中部槽连通所述针尖槽和所述针座槽,所述针尖槽朝 向所述针座槽的方向为水平方向。
所述面板上设有用于容纳所述模具的全部所述成型槽的成型孔,所述成型孔用于成型基底层。
所述模具的顶部向上突出形成隔离部,所述隔离部围绕所述成型槽的侧壁的周向设置。
当所述模具嵌合于所述底座的所述凹槽内,所述面板压合于所述底座和所述模具的顶部时,所述隔离部的高度大于或等于面板的高度。
具体的,沿所述成型槽的所述针尖槽朝向针座槽的方向,所述成型槽底壁向外延伸形成凸起部形成槽,所述凸起部形成槽用于成型所述微针的第三侧壁上的凸起部。
具体的,所述成型槽的成型槽底壁的下边绕所述成型槽底壁的上边旋转至所述成型槽底壁抵靠所述模具的顶部时,所述下边的长度大于所述下边与所述成型槽的两个交点的连线长度。
一种平面微针制备方法,采用上述的平面微针制造设备,包括如下步骤:
A1:组装底座、模具和面板。
A2:向所述模具的针尖槽内注入载药液,干燥为所述微针的所述针尖。
A3:向所述模具的中部槽、针座槽和所述面板的成型孔内注入原料液后,沿所述面板的顶部刮平原料液。
所述成型孔内的原料液干燥为所述基底层,所述模具的针座槽内的原料液干燥为所述微针的所述针座,所述模具的中部槽内的原料液干燥为所述微针的所述中部。
具体的,步骤A3中还包括:
向所述面板的所述成型孔内注入原料液后,沿所述模具的所述针尖槽朝向所述针座槽的方向刮平所述载药液。
或者,向所述面板的所述成型孔内注入原料液至布满所述成型孔,沿所述面板的顶部刮平原料液后,抽真空。
或者,向所述面板的所述成型孔内注入原料液至布满所述成型孔,沿所述面板的顶部刮平原料液后,离心。
一种平面微针立形设备,应用于立形上述平面微针,包括平面微针传送组件和平面微针翻转组件。
所述平面微针传送组件包括平面微针传送带,所述平面微针传送带用于将所述平面微针传送至所述平面微针翻转组件。
所述平面微针翻转组件用于向所述平面微针的微针施压,以将微针绕所述第三侧壁与所述基底层的连接处翻转,以使所述微针由第一侧壁和所述基底层位于同一平面翻转至所述第三侧壁与基底层所在平面间的夹角为0°~±10°,以完成微针立形。
具体的,所述平面微针翻转组件可以为真空负压吸附黏合件,真空负压吸附黏合件用于从微针的下方向微针施加负压气流。
或者,所述平面微针翻转组件为风压黏合件,风压黏合件用于从微针的上方向微针施加气流。
或者,所述平面微针翻转组件为滚轮接触压合件,滚轮接触压合件用于在所述平面微针上滚动,以对所述微针施加压力。
具体的,平面微针翻转组件可以包括翻转机构和微针容纳机构。所述翻转机构为压板。
所述翻转机构用于向所述微针施压,以使所述微针绕所述第一边旋转,至位于所述微针容纳机构顶部的容纳槽内,以完成所述微针立形。
具体的,所述压板的底部设置多个施压部,多个所述施压部和多个所述容纳槽一一对应地设置。
具体的,所述施压部的纵向截面为向下突出的弧形或V字型。
具体的,平面微针翻转组件还可以包括翻转机构和微针容纳机构。所述翻转机构包括第一滚轮,所述第一滚轮用于向所述微针施压,以使所述微针绕所述第一边旋转,至位于所述微针容纳机构顶部的容纳槽内,以完成所述微针立形。所述第一滚轮和所述微针容纳机构能够相向移动。
具体的,所述翻转机构还包括第二滚轮和第三滚轮。
所述第二滚轮上绕设粘性层,所述第二滚轮用于向所述第一滚轮传送所述粘性层,所述第三滚轮用于缠绕并储存由所述第一滚轮上的所述粘性层撕除得到的保护膜,所述第一滚轮用于向所述微针施压,并将所述粘性层粘附在所述基底层远离所述微针的一侧以及所述微针上。
具体的,所述第一滚轮上靠近所述第三滚轮的一侧设置保护膜剥离结构,所述保护膜剥离结构用于控制由所述粘性基底上剥离所述保护膜的位置。
具体的,所述微针容纳机构还包括多组间隔设置的固定板组件。
所述固定板组件包括第一夹持板和第二夹持板,所述第一夹持板能够沿靠近或远离第二夹持板方向移动。
所述第一夹持板抵靠在所述第二夹持板上时,所述第一夹持板和所述第二夹持板之间形成所述容纳槽。
所述微针位于所述容纳槽内时,所述第一夹持板和所述第二夹持板夹持所述微针。
具体的,所述微针容纳机构远离所述平面微针传送组件的一端设置限位板,所述平面微针抵靠在所述限位板上。
具体的,所述平面微针传送组件包括平面微针传送带和立形传送带。所述平面微针传送带倾斜设置,用于传送所述平面微针,所述立形传送带水平设置,且位于所述平面微针传送带的下端,所述立形传送带用于传送具有粘性的粘性层,并接受来自所述平面微针传送带的所述平面微针。所述平面微针传送带的延伸方向和所述立形传送带的延伸方向间的夹角为135°-179°。
本发明的有益效果为:
本发明的平面微针,第一侧壁与基底层位于同一平面。基于上述微针膜结构,在用于成型微针的模具中的成型槽中,用于成型针尖的针尖槽朝向用于成型针座的针座槽的方向为水平方向,以减小成型槽的深度,并减小成型槽的最大深度和最大长度的比值,便于向成型槽的针尖槽内精确灌注原料液,适用于油水混合物或黏性较高的原料液的灌注,且能够避免原料液飞溅污染中部槽和针座槽,使成型出的微针仅在针尖处载药,以精确控制微针贴在使用时的给药量。并且,减小成型槽的深度以及最大深度和最大长度的比值,还能减小微针成型后与成型槽间的脱模阻力,避免微针断裂,提高微针的良品率,并能降低成本。
附图说明
图1为本发明实施例1的平面微针的立体示意图;
图2为本发明实施例2的微针贴的立体示意图(微针为四棱锥);
图3为图2的另一视角示意图;
图4为图3的局部放大示意图;
图5为本发明实施例2的微针贴的立体示意图(微针为四棱锥,且微针的第三侧壁设置凸起部);
图6为图5的局部放大示意图;
图7为本发明实施例2的微针贴的立体示意图(微针为五棱锥,且微针的第三侧壁设置凸起部);
图8为本发明实施例2的微针贴的立体示意图(微针为圆锥或椭圆锥);
图9为本发明实施例2的微针贴的立体示意图(微针为三棱锥,且微针的第一侧壁的两侧均设置凸起);
图10为本发明实施例2的微针贴的立体示意图(微针为四棱锥,且微针的第一侧壁的两侧以及第二侧壁上均设置凸起);
图11为本发明实施例2的微针贴的立体示意图(微针为四棱锥,微针的第一侧壁的两侧以及第二侧壁上均设置凸起,且微针的第三侧壁设置凸起部);
图12为本发明实施例3的平面微针成型设备的分解视图;
图13为图12的装配图;
图14为图12中模具和平面微针的分解视图;
图15为图12中模具的立体示意图(模具的成型槽底壁的下边的长度大于上边的长度);
图16为图12中模具的立体示意图(模具的成型槽底壁设置凸起部形成槽);
图17为图16中成型槽的另一视角示意图;
图18为本发明实施例5的平面微针立形设备的工作流程图(翻转机构为压板);
图19为图18中的平面微针翻转组件的工作流程图;
图20为图19的局部放大图(微针立形前);
图21为图19的局部放大图(微针立形后);
图22为图18的立体示意图;
图23为图22的局部放大图(微针立形前);
图24为图22的局部放大图(微针立形后);
图25为采用压板立形微针的过程示意图;
图26为图25中的压板设置施压部(施压部的纵向截面为向下突出的弧形)的示意图;
图27为图25中的压板设置施压部(施压部的纵向截面为向下突出的V字型)的示意图;
图28为本发明实施例5的平面微针立形设备的工作流程图(翻转机构为滚轮组件);
图29为图28的局部放大图;
图30为图28的立体示意图;
图31为图30的局部放大图(微针为四棱锥,微针立形后,微针的第三壁的第三边抵靠在基底层靠近微针的一侧);
图32为图30的局部放大图(微针为三棱锥,且设有突起结构);
图33为平面微针传送组件的局部视图;
图34为本发明的微针贴(设有粘性层);
图35为平面微针立形装置中采用真空负压吸附黏合件作为微针翻转件的主视图;
图36为图35中的D处放大图;
图37为图35的立体示意图;
图38为平面微针立形装置中采用风压黏合件作为微针翻转件的主视图;
图39为图38中的E处放大图;
图40为图38的立体示意图;
图41为平面微针立形装置中采用滚轮接触压合件作为微针翻转件的主视图;
图42为图41中的F处放大图;
图43为图41的立体示意图。
附图标记说明
1、平面微针;11、基底层;111、间隙;112、基底通孔;12、微针;121、第一侧壁;122、第二侧壁;123、第三侧壁;1231、第一边;1232、第二边;1233、第三边;1234、弧形边;124、针尖;125、中部;126、针座;127、凸起部;128、突起结构;129、弧形壁;
2、微针贴;21、粘性层;
31、底座;311、凹槽;32、模具;321、成型槽;3211、成型槽底壁;3212、针尖槽;3213、中部槽;3214、针座槽;a、成型槽底壁的上边;b、成型槽底壁的下边;3215、凸起部形成槽;3216、成型槽侧壁;322、隔离部;323、第一制突凹槽;33、面板;331、成型孔;
41、平面微针传送组件;4111、平面微针传送带;4112、立形传送带;412、储料器;4121、出料口;413、平面微针吸附器;414、挡板;4141、第一挡板;4142、第二挡板;42、平面微针翻转组件;4211、压板;42111、施压部;4212、第一滚轮;4213、第二滚轮;4214、第三滚轮;422、微针容纳机构;4221、容纳槽;4222、第一夹持板;4223、第二夹持板;4224、限位板;4225、顶壁;423、真空负压吸附黏合件;424、风压黏合件;425、滚轮接触压合件;4251、滚轮;4252、支撑架。
A、B、当微针立形后,微针的第三侧壁平行于基底层时,第三边投影于基底通孔上的投影边的两端端点;
F、G、第三侧壁的第三边和第二边的两个连接点;
H、I、第三侧壁的第一边的两端端点;
J、K、第三壁的弧形边与基座孔的两个交点;
C、D、成型槽底壁绕上边旋转至成型槽底壁平行于模具的顶壁时,下边与成型槽的两个交点;
θ、第三边抵靠在基底层靠近微针的一侧时,与第一边相邻的第二边和基底通孔侧壁间的夹角;
L1、第三侧壁尺寸;
L2、第三侧壁投影于粘性层上的尺寸。
具体实施方式
以下结合特定的具体实例说明本发明的实施方式,本领域技术人员可由本说明书所揭露的内容轻易地 了解本发明的其他优点与功效。本发明还可以通过另外不同的具体实施方式加以实施或应用,本说明书中的各项细节也可以基于不同观点与应用,在没有背离本发明的精神下进行各种修饰或改变。
在进一步描述本发明具体实施方式之前,应理解,本发明的保护范围不局限于下述特定的具体实施方案;还应当理解,本发明实施例中使用的术语是为了描述特定的具体实施方案,而不是为了限制本发明的保护范围。
实施例1
参照图1,本实施例提供一种平面微针,包括基底层11和微针12,微针12设置在基底层11上。微针12包括针尖124、中部125和针座126,中部125连接针尖124和针座126,针尖124朝向针座126的方向与基底层11延伸方向基本相同。微针12由模具32中的成型槽321成型。
参照图14,一方面,用于成型针尖124的针尖槽3212朝向用于成型针座126的针座槽3214的方向大致为水平方向,能够减小成型槽321的深度,并减小成型槽321的最大深度和最大长度的比值,便于向成型槽321的针尖槽3212内精确灌注原料液,且不限于原料液的类型。因成型槽321水平设置,向针尖槽3212灌注原料液时,无需经过中部槽3213和针座槽3214,可直接灌注至针尖槽3212内,从而避免原料液飞溅污染中部槽3213和针座槽3214,使成型出的微针12仅在针尖124处载药,以精确控制微针贴2在使用时的给药量。同时,减小成型槽321的最大深度和最大长度的比值,还能减小微针12成型后与成型槽321间的脱模阻力,避免微针12断裂,提高微针12的良品率,并能降低成本。另一方面,由于成型槽321水平设置,沿水平方向,针尖槽3212的尺寸可大于中部槽3213和/或针座槽3214,使微针12形成突起结构128等其他防止从皮肤中脱离的结构,如箭头型、塔松型、半葫芦型等,且能便于微针12脱模。
进一步,微针12的最大宽度和最大高度的比值为1:5~1:2。相对应的,用于成型微针12的成型槽321的最大深度和最大长度的比值为1:5~1:2。当微针12最大高度和最大宽度的比值大于5时,微针12太尖,扎入皮肤时微针12易断,而且微针12太长,易导致扎入皮肤时疼痛感强,引起用户不适。
参照图1-11,进一步,微针12为椎体,微针12可以为棱锥、圆锥或椭圆锥。
具体地,微针12为棱锥时:微针12包括第一侧壁121、周向侧壁和第三侧壁123。第一侧壁121与基底层11位于同一平面,第一侧壁121和周向侧壁均位于微针12的周向,第三侧壁123位于微针12的底部。第一侧壁121与周向侧壁的连接处和基底层11之间存在间隙111。当微针12为棱锥时,周向侧壁包括至少两个第二侧壁122。当微针12为圆锥或椭圆锥时,周向侧壁包括弧形壁129。
平面微针1需经立形后方可用于扎入皮肤,向皮肤中导入药物。微针12的立形过程为:微针12绕第一边1231翻转并穿过间隙111,并由微针12的第一侧壁121与基底层11处于同一平面翻转至第三侧壁123与基底层11大致处于同一平面或者部分抵靠于基底层11,即第三侧壁123与基底层11所在平面夹角为0°~±10°(当第三侧壁123倾斜于基底层11且位于基底层11的下方时,第三侧壁123与基底层11所在平面之间的夹角大于等于-10°且小于0°;当第三侧壁123倾斜于基底层11且位于基底层11的上方时,第三侧壁123与基底层11所在平面间的夹角大于0°且小于等于10°),完成微针12立形,并制备为微针贴2。此时,微针12与基底层11的相接处形成基底通孔112;当第三侧壁123位于基底通孔112中且与基底层11基本平行或第三侧壁123部分抵靠于基底层11上时,第三侧壁123与基底层11所在平面间的夹角为0°。
优选的,微针12立形后,微针12的针尖124朝向针座126的方向垂直于基底层11或与基底层11相交,在使用微针贴2时,按压微针贴2的方向与针座126朝向针尖124的方向基本重合,施加较小力时微针12即可顺利扎入皮肤,此时,微针12承受的横向切力几乎为0,能有效避免使用微针贴2时微针12发生断裂。
优选地,当微针12为棱锥时:
第一侧壁121与第三侧壁123间的夹角β为45°-90°,该角度影响微针12成型后的脱模难易度以及微针贴2的使用性能。当β大于90°时,无法完成微针12成型后的脱模。当β小于45°时,微针12立形后,微针12的第一侧壁121与基底层11间的夹角较小,导致微针12针尖124朝向针座126的方向与基底层11间的倾斜夹角较小,使用时,微针12无法扎入皮肤,或者,造成微针12扎入皮肤的阻力过大,导致微针12断裂,影响微针贴2的正常使用。
第二侧壁122与第三侧壁123间的夹角α为60°-90°,该角度影响微针12的体积和形状。当α小于60°时,针座126的宽度较大,使用微针贴2时,因针座126的宽度较大,导致针座126留在角质层内无法扎入目标层,影响微针12扎入皮肤后的给药稳定性,且会浪费针座126处的成型材料。当α大于90°时,微针12 的第二侧壁122与第三侧壁123间的夹角较大,导致立形后微针12的高度较小,且立形后的微针12,针尖124朝向针座126的方向与基底层11间的倾斜夹角较大,使用微针贴2时,外力方向与针尖124朝向针座126的方向间的夹角较大,易导致微针12无法扎入皮肤,或者因扎入阻力较大,导致微针12断裂,影响微针贴2的正常使用。
进一步,第三侧壁123包括第一边1231和活动边,第一边1231连接基底层11。
当微针12为棱锥时,活动边包括至少一个第二边1232和至少一个第三边1233。第一边1231连接基底层11,第一边1231和至少一个第三边1233相对设置。第二边1232连接第一边1231和第三边1233。
例如,当微针12为三棱锥时,第三侧壁123包括第一边1231、第二边1232和第三边1233。当微针12为四棱锥时,第三侧壁123包括第一边1231、两个第二边1232和第三边1233,第一边1231和第三边1233相对设置,两个第二边1232相对设置,且均连接第一边1231和第三边1233。当微针12为五棱锥时,第三侧壁123包括第一边1231、两个第二边1232和两个第三边1233,第一边1231和两个第三边1233相对设置,两个第二边1232相对设置,且均连接第一边1231和第三边1233。相近似地,当微针12的棱边大于或等于四个时,第三侧壁123的第一边1231和至少一个第三边1233相对设置,第二边1232连接第一边1231和第三边1233。
优选地,微针12的棱边大于等于四个,活动边包括至少两个第二边1232和至少一个第三边1233。第一边1231连接基底层11,第一边1231和第三边1233相对设置,第二边1232连接第一边1231和第三边1233。当微针12立形时:微针12能够绕第一边1231翻转,并由第一侧壁121与基底层11位于同一平面翻转至第三侧壁123的第三边1233抵靠在基底层11靠近微针12的一侧。
当微针12立形后,微针12的第三侧壁123部分抵靠于基底层11,第三侧壁123的第三边1233和第二边1232的两个连接点FG的连线长度大于该连线投影于基底通孔112所形成的投影边AB的长度,以使微针12的第三侧壁123的第三边1233能够抵靠在基底层11上,此时,第三侧壁123在基底层11上形成多边形的抵接面(基底层11上HAF或IGB所围合成抵接面),以使第三侧壁123能够稳定抵靠在基底层11上。即微针12绕第一边1231旋转并穿过基底通孔112完成立形后,第三侧壁123的面积大于第三侧壁123所对应的基底通孔112面积,使得第三侧壁123部分抵靠在基底层11上,以支撑在基底层11上,实现微针12稳定立形,避免施加在微针12上的翻转力取消后微针12回弹并绕第一边1231反向旋转。
更优选地,第三侧壁123的第三边1233和第二边1232的连接点连线FG的长度小于或等于第一边1231的长度(即HI的长度),以便于微针12成型后的脱模。
参照图3-4,优选地,当微针12的第三侧壁123的第三边1233抵靠在基底层11靠近微针12的一侧时,与第一边1231相邻的第二边1232和基底通孔112侧壁间的夹角θ的取值范围为0°<θ≤10°。当θ大于10°时,易导致微针12的翻转阻力增大,导致微针12立形时受损。更优选地,1°<θ≤6°。
当微针12为圆锥或椭圆锥时,活动边包括弧形边1234。
微针12能够绕第一边1231翻转,并由第一侧壁121与基底层11位于同一平面翻转至第三侧壁123的弧形边1234抵靠在基底层11靠近微针12的一侧。
具体地,第三侧壁123的弧形边1234抵靠在基底层11靠近微针12的一侧时,弧形边1234和基底通孔112相交于J点和K点,以使第三侧壁123和基底层11间形成抵接面,进而使第三侧壁123能够稳定抵靠在基底层11上。即微针12绕第一边1231旋转并穿过基底通孔112完成立形后,第三侧壁123的面积大于第三侧壁123所对应的基底通孔112面积,使得第三侧壁123部分抵靠在基底层11,以支撑在基底层11上,实现微针12稳定立形,避免施加在微针12上的翻转力取消后微针12回弹并绕第一边1231反向旋转。
通过在微针12立形后,第三侧壁123的第三边1233或者弧形边1234抵靠在基底层11上的设置,能够提高微针12和基底层11间的抓持力,保证微针12的第三侧壁123稳定抵压于基底层11,避免微针12立形过程中,施加在微针12上的翻转力消失后,微针12回弹导致微针12的第三侧壁123与基底层11存在较大的夹角,导致在粘附粘性层21时形成坏品或者微针12扎入皮肤时的阻力增大,影响微针贴2的正常使用。同时,立形后的微针12的弧形边1234或第三边1233抵靠在基底层11上时,第三侧壁123与基底层11间形成抵接面,该抵接面为微针12提供立形于基底层11上的支撑力,因此,微针12能稳定立形于基底层11上,可以不需要在微针12和基底层11上设置用于辅助微针12立形的粘性层21。这种未设置粘性层21的微针贴2能够适用于对粘性层21材料过敏的人群使用。
参照图9,进一步,微针12的第一侧壁121的两侧均设置突起结构128,突起结构128沿针尖124朝向针 座126的方向延伸,形成倒刺状,且突起结构128均位于针尖124。通过在微针12上设置突起结构128,以在微针12扎入皮肤后,在皮肤回弹力的作用下,突起结构128能够二次扎入皮肤中,提高微针12和皮肤的抓持力,避免微针12在皮肤回弹力的作用下被挤出皮肤,且由于微针12与皮肤间的抓持力足够大,可以在微针贴2上取消设置用于粘附在皮肤上的粘性层21,以适用于对黏性胶敏感的人群。
参照图10~11,优选地,当微针12为棱锥,且微针12的棱边大于等于四个时,与第一侧壁121相对的第二侧壁122上设置突起结构128,突起结构128沿针尖124朝向针座126的方向延伸,形成倒刺状,突起结构128优选位于针尖124。当微针12为圆锥或椭圆锥时,弧形壁129上设置突起结构128,突起结构128沿针尖124朝向针座126的方向延伸,形成倒刺状,突起结构128优选位于针尖124。
通过在第二侧壁122或弧形壁129上设置突起结构128,并在模具32的成型槽321中相应设置用于成型该突起结构128的第二制突凹槽,以在成型微针12时,能够精确向第二制突凹槽内注入原料液,进而能够精确控制成型后的微针12的载药量。更优选地,第二侧壁122或弧形壁129上均设置多个突起结构128,并在模具32的成型槽321中相应设置分别用于成型该多个突起结构128的多个第二制突凹槽,以在成型微针12时,能够分别向成型槽321的多个第二制突凹槽中分别注入不同的原料液,以精确控制成型后的微针12的载药量,并使成型出的微针12能够承载多种药物。
参照图5-7,进一步,沿针尖124朝向针座126的方向,第三侧壁123向外延伸形成凸起部127,凸起部127能够穿过基底通孔112。
在微针12立形的过程中,未设置凸起部127的平面微针1,需要将微针12翻转至微针12的第三侧壁123与基底层11靠近微针12的一侧存在较大夹角,所需的翻转力较大,增大了向微针12施加翻转力的翻转机构的选材及选型难度。而设置凸起部127的平面微针1,仅需将微针12翻转至凸起部127和基底层11远离微针12的一侧齐平,此时,微针12的第三侧壁123与基底层11靠近微针12的一侧间的夹角较小,进而减小了施加在微针12上的翻转力,便于微针12立形,并降低了向微针12施加翻转力的翻转机构的选材及选型难度。
优选地,凸起部127的最大高度大于或等于基底层11的厚度,以在微针12的第三侧壁123的第三边1233抵靠在基底层11靠近微针12的一侧时,凸起部127和基底层11远离微针12的一侧齐平,或者,凸起部127突出于基底层11远离微针12的一侧。当凸起部127的最大高度小于基底层11的厚度时,将微针12翻转至凸起部127和基底层11远离微针12的一侧齐平时,易导致微针12的第三侧壁123未穿过或未完全穿过基底层11,进而使微针12的第三边1233无法抵靠或无法稳定抵靠在基底层11靠近微针12的一侧,以避免微针12立形过程中,施加在微针12上的翻转力消失后,微针12回弹导致微针12的第三侧壁123倾斜于基底层11。
更优选地,凸起部127的最大高度等于基底层11的厚度。当凸起部127的最大高度大于基底层11的厚度时,微针12立形后的凸起部127突出于基底层11远离微针12的一侧,在成型为微针贴2时,易因基底层11远离微针12的一侧不是光滑平面,影响微针贴2的使用舒适性以及微针贴2的美观性。同时,在向微针12的凸起部127粘贴粘性层21时,易因凸起部127突出于基底层11远离微针12的一侧,导致粘性层21不平。
实施例2
参照图2-11和34,在实施例1的基础上,本实施例提供一种微针贴。具体包括如下两种类型:
参照图34,当微针贴2设有粘性层21时:微针12立形后,基底层11远离微针12的一侧以及微针12的第三侧壁123或者凸起部127粘附于粘性层21,以成型为设有粘性层21的微针贴2。该微针贴2能够在微针12扎入皮肤后,通过基底通孔112内露出的粘性层21稳定粘附于皮肤表面,避免在皮肤回弹力的作用下将微针12挤出,影响微针贴2的正常使用。
当微针贴2未设有粘性层21时:微针12中含有易溶于水的成分,例如透明质酸钠,微针12立形后即成型为未设置粘性层21的微针贴2。
使用未设置粘性层21的微针贴2时,先将微针12的针尖124朝向皮肤,随后,按压微针贴2,至微针12扎入皮肤中。用纯净水涂抹基底层11,以溶解基底层11以及微针12未进入皮肤的部分,随后,皮肤回弹并封闭微针12穿过皮肤时所形成的通孔,使微针12包覆于皮肤中,实现微针12的溶解给药。由于基底层11中含有透明质酸钠,纯净水溶解基底层11时,基底层11中的透明质酸钠转变为溶液,并在皮肤表面形成保护膜,以减少皮肤表面的水分流失,进而加快微针12在皮肤内部的溶解速度。进而,这种未设置粘性层21的微针贴2还适用于儿童或其他特殊患者、宠物,能够避免儿童或其他特殊患者、宠物在使用微针贴2时抓挠粘性层21导致微针12随粘性层21脱落而无法实现微针12的给药的情况。
微针12上优选设置突起结构128,当微针12受到皮肤施加的挤压回弹力时,微针12上的突起结构128能够二次扎入皮肤中,增大微针12与皮肤间的抓持力,避免皮肤将微针12挤出。更优选的,多个突起结构128交错的设置于第一侧壁121两侧,相较于对称设置在第一侧壁121两侧的突起结构128,交错设置于第一侧壁121两侧的突起结构128能够减小微针的横截面积,以减小微针扎入皮肤时的阻力,进而减小皮肤损伤并减弱疼痛感。
更优选的,在设有突起结构128的微针的第三侧壁123与基底层11的连接处设置易撕口,易撕口为形成于第三侧壁123与基底层11连接处的缺口。在微针贴2使用时,将微针12扎入皮肤后,可以方便的由易撕口处施力撕除基底层11,且由于微针12上设有突起结构128,微针12与皮肤间的抓持力较大,微针12可稳定嵌合入皮肤中,实现基底层11和微针12的快速分离,避免微针贴2在使用时,由于基底层11长时间粘附于皮肤上导致的不适,尤其适合儿童、宠物或者精神病患者使用,且能避免使用者抓挠或舔舐基底层11而导致微针贴2脱落。
实施例3
本实施例在实施例1的基础上,提供一种平面微针的制造设备,其包括底座31、模具32和位于底座31上方的面板33。
参见11-18,底座31的顶部设置用于容纳模具32的凹槽311。模具32的顶部设置多个用于成型微针12的成型槽321。成型槽321包括针尖槽3212、针座槽3214和中部槽3213,中部槽3213连通针尖槽3212和针座槽3214,成型槽321的针尖槽3212朝向针座槽3214的方向为水平方向。面板33上设有用于容纳全部成型槽321的成型孔331,成型孔331用于成型基底层11。模具32的顶部向上突出形成隔离部322,隔离部322围绕成型槽321的成型槽侧壁3216的周向设置。当模具32嵌合于底座31的凹槽311内,面板33压合于底座31和模具32的顶部时,隔离部322的高度至少与面板33的高度一致。
现有技术中的微针制造设备,普遍为采用原料液一次性成型出微针12垂直于基底层11方向延伸的微针贴2,模具32的成型槽321的最大深度和最大长度的比值普遍为2-5。而本实施例中的平面微针制造设备,其用于成型微针12的成型槽321中,成型槽321的针尖槽3212朝向针座槽3214的方向为水平方向,成型槽321的最大深度和最大长度的比值为1:5~1:2。
相较于现有技术,本实施例中的成型槽321能够极大降低成型槽321的深度,以及最大深度和最大长度的比值。由此,本实施例中的平面微针制造设备,一方面能够向成型槽321的针尖槽3212内精确灌注载有药物功效成分的原料液,避免原料液飞溅污染中部槽3213和针座槽3214,成型槽321的中部槽3213和针座槽3214填充不含有药物的原料液,进而使成型出的微针12仅在针尖124处载药,以精确控制微针贴2在使用时的给药量。由于成型槽321的最大深度和最大长度的比值为1:5~1:2,成型槽321深纵比较小,微针12制备时无需借助真空吸附、离心或者高压喷射等工艺即可实现原料液的灌注,以缩短制备工序并降低成本。同时,因成型槽321呈大致水平方向设置,微针12的针尖124和中部125脱模时均不受中部125和/或针座126的形状影响,针尖124的体积可大于中部125和/或针座126的体积,即微针12可设置成箭头型、塔型、葫芦型、或上下设置的半圆锥体和半圆台体的组合体等结构或在微针针尖124成型出突起结构128,从而增强针尖124扎入皮肤后的嵌合稳定性,避免微针12扎入皮肤后由于皮肤的形变而被挤压出来,保证微针12中的载药成分在皮肤中溶解,实现精准给药。
优选的,微针12为箭头型、塔型、葫芦型、或上下设置的半圆锥体和半圆台体的组合体等结构。当微针12为箭头型、塔型、葫芦型、或上下设置的半圆锥体和半圆台体的组合体等结构时,其针尖124和/或中部125构成微针12体积更大的凸起部127,提高微针12与皮肤间的抓持力,微针12扎入皮肤后皮肤受微针12挤压而形变恢复后,微针在皮肤中嵌合的更稳定,微针12对皮肤的抓持力更大。
本实施例中由于降低了成型槽321的深度,能够便于将高粘度原料液、油水混合物原料液等原料液注入成型槽321内,以满足采用高粘度原料液、油水混合物原料液等原料液成型微针12的需求。高粘度原料液液滴体积相对较大,现有微针垂直于基底层而成型的微针制备模具由于成型槽的深纵比大,高粘度原料液液滴注入后成型槽后由于体积大粘度高流动性差,导致原料液无法完整填充微针针尖部从而无法实现产业化或者良品率极低,增加成本;又或者需要在严苛的条件才能填充成型完整微针,极大的增加生产成本,造成资源浪费。油水混合物原料液易形成悬浮液,提高原料液粘度,因此也导致相同问题。本实施例中成型槽321由于深纵比小,成型槽321入口尺寸也较大,且可借助工具刮平填充液等方式使高粘度原料液快速 完整的填充成型槽321,从而实现高良品率的产业化,降低生产成本,满足需求。另一方面本实施例中的平面微针的制造设备能够减小微针12与成型槽321间的脱模阻力,避免微针12断裂,提高微针12的良品率并降低成本。
参照图15,优选地,成型槽321的成型槽底壁3211的下边b的长度小于或等于上边a的长度。成型槽底壁3211的下边b对应成型为微针12的第三边1233,上边a对应成型为微针12的第一边1231。成型槽底壁3211的下边b的长度大于上边a的长度时,成型出的微针12的第三边1233的长度大于第一边1231的长度,脱模时,第三边1233会接触成型槽321,导致微针12脱模的阻力增大,使微针12受损甚至无法脱模。因此,本实施例中成型槽底壁3211的下边b的长度优选为小于或等于上边a的长度,以使成型出的微针12的第三边1233的长度小于或等于第一边1231的长度,以便于微针12脱模,并便于微针12的立形。
进一步,若成型槽底壁3211绕上边a旋转至成型槽底壁3211与模具32的顶壁抵接时,下边b的长度大于下边b与成型槽321的两个交点CD的连线长度,以使成型出的微针12立形后,微针12的第三侧壁123的第三边1233和第二边1232的两个连接点FG的连线长度大于该连线投影于基底通孔112所形成的投影边AB的长度,进而使微针12的第三边1233能够抵靠在基底层11靠近微针12的一侧上。
进一步,沿成型槽321的针尖槽3212朝向针座槽3214的方向,成型槽底壁3211向外延伸形成凸起部形成槽3215,凸起部形成槽3215用于成型微针12的第三侧壁123上的凸起部127。
参照图14,进一步,模具32的顶部向上突出形成隔离部322,隔离部322围绕成型槽321的成型槽侧壁3216的周向。当模具32嵌合于底座31的凹槽311内,面板33位于底座31和模具32顶部时,隔离部322的高度至少与面板33的高度一致。制备平面微针1时,先组合底座31、模具32和面板33,由面板33的成型孔331内注入原料液,原料液进入模具32的成型槽321内。成型孔331内的原料液成型为基底层11,成型槽321内的原料液成型为微针12。而位于模具32顶部的隔离部322阻隔了原料液,以使成型出的基底层11在对应隔离部322的位置处形成缺口,即第一侧壁121与第二侧壁122的连接处和基底层11之间存在间隙111,进而在微针12立形后,微针12能够绕第一边1231旋转并穿过间隙111,由第一侧壁121与基底层11位于同一平面翻转至第三侧壁123与基底层11大致处于同一平面或者部分抵靠基底层11,此时第三侧壁123与基底层11之间的夹角为0°~±10°,完成微针12立形。
优选地,沿成型槽321的宽度方向,隔离部322的两侧向外突出形成第一制突凹槽323,第一制突凹槽323内的原料液用于成型微针12的第一侧壁121两侧的突起结构128。成型槽321的成型槽侧壁3216上设有第二制突凹槽,第二制突凹槽用于成型微针12的周向侧壁上的突起结构128。
实施例4
在实施例1-3的基础上,本实施例还提供一种平面微针的制备方法。具体包括如下步骤:
A1:配置原料液,原料液包括载药原料液和基底原料液。
A2:组装底座31、模具32和面板33,将模具32置于底座31的凹槽311中,面板33的成型孔331位于模具32的上方,且容纳模具32的全部成型槽321。
A3:向针尖槽3212内填充载药原料液,载药原料液干燥为微针12的针尖124。
A4:向成型孔331内填充基底原料液,至布满成型孔331和面板33后,沿面板33的顶部刮平基底原料液。成型孔331内的基底原料液干燥为基底层11,针座槽3214内的基底原料液干燥为针座126,中部槽3213内的基底原料液干燥为中部125。
位于模具32顶部的隔离部322阻隔了基底原料液,成型出的基底层11在对应隔离部322的位置处形成缺口,即在第一侧壁121与第二侧壁122的连接处和基底层11之间形成间隙111。
A5:拆除面板33,将微针12与成型槽321分离。
具体地,步骤A1中具体还包括:
当药物为水溶性药物时:载药原料液中包括透明质酸钠溶液、有效成分和水。透明质酸钠溶液中含5%~50%的分子量为3~30万的透明质酸钠溶液,以及1%~20%的分子量小于等于1万的透明质酸钠溶液。有效成分的占比为载药液的1%~20%。水的占比为载药液的50%~80%。该载药液中固含量为20%~60%。
当药物为油溶性药物时:载药原料液中包括透明质酸钠溶液和油溶性药物活性成分溶液。油溶性药物活性成分溶液的密度大于1且与透明质酸钠溶液的密度相近。由于油溶性药物活性成分溶液与透明质酸钠 溶液的密度相近,油溶性药物活性成分能够稳定悬浮在透明质酸钠溶液中,在载药液干燥过程中不会发生下沉或上浮,保证载药液干燥后,其中的油溶性药物活性成分能够稳定的分布在透明质酸钠中。透明质酸纳也可以替换成其他可溶性微针骨架材料。
当微针12不可溶于水和人体组织液,以用于组织液提取和检测时:载药原料液包括成分液和2%氯化钙乙醇溶液。其中,成分液包括:15%的海藻酸钠、10%的聚乙烯醇和75%的水。使用时,将成分液中的三种成分混合均匀后,于60~65℃温度下加热溶解,保温脱泡备用。2%氯化钙乙醇溶液包括2%的氯化钙和98%的无水乙醇。使用时,将2%氯化钙乙醇溶液中的两种成分搅拌溶解后备用。当平面微针1成型后,将平面微针1置于2%的氯化钙乙醇溶液中浸泡1~2分钟,以使海藻酸钠和氯化钙发生化学反应得到海藻酸钠钙,海藻酸钠钙不溶于水和人体组织液,可用于组织液提取和检测。随后,在35℃的鼓风干燥箱中干燥20~30分钟。
具体地,步骤A4中还包括:
向面板33的成型孔331内注入原料液后,沿模具32的针尖槽3212朝向针座槽1214的方向刮平载药液,由于针尖槽3212朝向针座槽1214的方向其深度逐渐增大,沿此方向刮平载药液时,随着原料液填充成型槽321,成型槽321内的气体内的气体沿着针尖槽3212向针座槽1214方向被排出,避免成型后的微针12中存在气泡,保证微针12的载药量精准和强度符合要求。
或者,向面板33的成型孔331内注入原料液至布满成型孔331,沿面板33的顶部刮平原料液后,置于真空箱中,于-0.2Mpa的真空环境下抽真空2min,以排出成型槽321内原料液中的气体,避免成型后的微针12中存在气泡。且该抽真空过程所需功率较低,时间较短,能够节约能源,并缩短微针12的成型时间,提高生产效率。
或者,向面板33的成型孔331内注入原料液至布满成型孔331,沿面板33的顶部刮平原料液后,置于离心机中,于200r/min的转速下离心1min后,于1000r/min的转速下离心3min,以排出成型槽321内原料液中的气体,避免成型后的微针12中存在气泡。且该抽离心过程所需功率较低,时间较短,能够节约能源,并缩短微针12的成型时间,提高生产效率。
具体地,步骤A4中还包括:
在干燥过程中:
向所述面板33的所述成型孔331内注入原料液后,于25%-30%相对湿度的环境下干燥20-30min,实现第一阶段的快速干燥,再于40%-60%相对湿度的环境下干燥10-30min,实现第二阶段的慢速干燥,由快速干燥和慢速干燥相结合的干燥方式,能够避免平面微针7在干燥过程中发生卷曲或变形,进而保证了平面微针1的成品质量,并能缩短平面微针1的干燥时间,缩短平面微针1的生产周期,提高平面微针1的生产效率并能降低生产成本。
或者,向面板33的成型孔331内注入原料液后,于25%-60%相对湿度的干燥箱中整夜缓慢干燥,以保证平面微针1在干燥过程中不发生卷曲或变形,进而保证平面微针1的成品质量。
具体地,步骤A5中还包括:
原料液干燥后,拆除面板33,采用真空吸附的方式向基底层11施加向上的吸力,以快速将基底层11与模具32分离,从而实现微针12和模具32的成型槽321分离,并成型为平面微针1。
或者,原料液干燥后,拆除面板33,沿微针12的针座126朝向针尖124的方向揭起基底层11,以将微针12和成型槽321分离,并成型为微针贴2。在此过程中,沿微针12的针座126朝向针尖124的方向揭起基底层11,即由微针12的第一侧壁121和第三侧壁123与基底层11的连接处施力带动微针12与成型槽321分离,避免微针12的第一侧壁121和第三侧壁123与基底层11的连接处发生断裂后,导致微针12和基底层11分离出现不良品,以提高平面微针1的良品率并降低平面微针1的生产成本。
综上,上述制备方法操作简单且效率较高。步骤A3和A4中,可借助高压喷射、真空吸入或离心的方式注入载药原料液和基底原料液。
实施例5
参照图18-33,在实施例1-2的基础上,本实施例还提供一种平面微针立形设备,用于向平面微针1的微针12施压,使微针12绕第一边1231翻转并穿过间隙111,并由微针12的第一侧壁121与基底层11位于同一平面翻转至第三侧壁123与基底层11大致处于同一平面或者部分抵靠于基底层11,此时第三侧壁123与基底层 11所在平面间的夹角为0°~±10°,以完成微针12立形,此时,微针12与基底层11的相接处形成基底通孔112。
进一步,平面微针立形设备包括平面微针传送组件41和平面微针翻转组件42。平面微针传送组件41用于将平面微针1传送至平面微针翻转组件42,平面微针翻转组件42用于将微针12立形。
进一步,平面微针传送组件41包括平面微针传送带4111、储料器412和平面微针吸附器413。储料器412用于存储平面微针1,多个平面微针1上下堆叠设置。平面微针传送带4111位于储料器412的下方,平面微针吸附器413设置在平面微针传送带4111上,平面微针吸附器413用于逐个将平面微针1吸附至平面微针传送带4111上,平面微针传送带4111用于将平面微针1传送至平面微针翻转组件42。
参照图33,具体地,储料器412的底部设置用于排出平面微针1的出料口4121。出料口4121具体为:形状与平面微针1相似且面积小于平面微针1,以存储平面微针1。出料口4121与平面微针传送带4111平行设置,且出料口4121与平面微针传送带4111的间距大于平面微针1的厚度。
平面微针吸附器413贯穿平面微针传送带4111设置。平面微针吸附器413可沿其轴向移动,并能够排出脉冲的负压气流,以逐层将平面微针1由出料口4121吸附并平铺至平面微针传送带4111上。当需要吸附平面微针1时,平面微针吸附器413沿其轴向上移并靠近储料器412的底部,并排出脉冲的负压气流。当吸附完成后,平面微针吸附器413沿其轴向下移回复至位于平面微针传送带4111的下方,以将平面微针1转移至平面微针传送带4111上。
优选地,平面微针吸附器413位于储料器412中的平面微针1中心处的下方,以使平面微针吸附器413排出的吸附力作用于平面微针1的中心处,当平面微针1变形并由出料口4121排出时,平面微针1的中心处先贴附于平面微针吸附器413上,随后,该吸附力在平面微针1的边缘处形成拉力,在拉力的作用下,平面微针1的边缘处延展并平铺于平面微针传送带4111上,以实现将平面微针1由储料器412移动并平铺至平面微针传送带4111上。
具体地,平面微针传送带4111的两侧均设置挡板414,当平面微针传送带4111传送平面微针1时,挡板414能够为平面微针1的移动起导向作用。
进一步,平面微针翻转组件42包括翻转机构和微针容纳机构422,翻转机构用于将微针12由微针12的第一侧壁121与基底层11位于同一平面翻转至第三侧壁123与基底层11大致处于同一平面或者部分抵靠于基底层11,以完成微针12立形。微针容纳机构422的顶部设置容纳槽4221,立形后的微针12位于容纳槽4221内。微针容纳机构422顶部的顶壁4225能够支撑基底层11,容纳槽4221的侧壁能够支撑微针12,以避免微针12立形过程中,在翻转机构向平面微针1施压时,基底层11及微针12受损。
翻转机构设置于机架(附图中未示出)上,微针容纳机构422设置于立形传送带4112(附图33中未示出)上,立形传送带4112用于带动微针容纳机构422水平移动。
容纳槽4221的长度大于微针12的针尖124至针座126的高度,以避免微针12立形过程中碰撞容纳槽4221导致受损,进而保证微针12立形后的良品率。容纳槽4221的深度大于微针12的针尖124至针座126的高度,以避免微针12立形后容纳于容纳槽4221内时碰撞容纳槽4221的底部导致受损,进而保证微针12立形后的良品率。由于容纳槽4221的长度和深度均大于微针12的针尖124至针座126的高度,当平面微针1转变为微针贴2后,能够便于将微针12由容纳槽4221内分离。
具体地,容纳槽4221设置多个,多个容纳槽4221间隔设置在微针容纳机构422的顶部,且多个容纳槽4221和平面微针1上的多排微针12一一对应地设置。
进一步,微针容纳机构422优选为弹性材质,例如硅胶和橡胶,以使微针容纳机构422顶部的顶壁4225能够为基底层11提供弹性支撑,容纳槽4221侧壁能够为微针12提供弹性支撑。当翻转机构向平面微针1施压时,微针容纳机构422的顶壁4225与基底层11同时受压,顶壁4225能够提供支撑基底层11的反作用力,且顶壁4225受压时能随基底层11发生弹性形变,避免基底层11受损,容纳槽4221的侧壁能够提供支撑微针12的反作用力,且容纳槽4221的侧壁受压时能随微针12发生弹性形变,避免微针12受损。
进一步,微针容纳机构422远离平面微针传送带4111的一端设置限位板4224,限位板4224能够上下移动,当平面微针1位于微针容纳机构422的顶部时,平面微针1抵靠在限位板4224上,以提高平面微针1的位置精度。
进一步,翻转机构包括压板4211,或者,翻转机构包括第一滚轮4212,或者,翻转机构包括滚轮组件。
参照图18-27,进一步,当翻转机构包括压板4211时:
压板4211为弹性材质,压板4211能够将平面微针1的全部微针12同时翻转至立形,提高了立形效率。
压板4211安装于机架(未示出)上,压板4211沿竖直方向厚度均匀,压板4211可相对于机架沿竖直方向下移至与微针12的第三侧壁123接触并向第三侧壁123施压,使微针12绕第一边1231旋转至第三侧壁123与基底层11大致处于同一平面或者部分抵靠基底层11,即第三侧壁123与基底层11所在平面间的夹角为0°~±10°,完成平面微针1的立形。
或压板4211安装于机架(未示出)上,压板4211远离平面微针1的一侧通过弹簧等弹性机构(未示出)与机架连接,压板4211可沿竖直方向相对于机架移动。压板4211为楔形体,沿竖直方向,压板4211横截面为三角形或梯形。楔形体的压板4211的延伸方向与平面微针1的微针12的针座126指向针尖124的方向一致,即当微针12的第三侧壁123背对平面微针传送带4111设置时,压板4211远离平面微针传送带4111一端的厚度大于其靠近平面微针传送带4111一端的厚度。当压板4211向下移动抵压平面微针1时,微针12在楔形体的压板4211的作用下,微针12的第三侧壁123与楔形体的压板4211的倾斜面接触形成接触点,压板4211给予第三侧壁123一个由接触点指向针尖124的分力,从而使微针12绕第一边1231旋转。随着压板4211继续下压,第三侧壁123受到压板4211沿水平方向的分力和竖直向下的分力,从而使微针12继续绕第一边1231旋转,直至第三侧壁123与基底层11大致处于同一平面或者部分抵靠基底层11,即第三侧壁123与基底层11所在平面间的夹角为0°~±10°,完成平面微针1的立形。由于压板4211远离平面微针1的一侧通过弹簧等弹性机构与机架连接,当楔形体的压板4211下压平面微针1时可通过弹簧机构调节压板4211与平面微针1之间的压力,从而避免平面微针1因受压力过大而导致变形造成不良品。
或压板4211安装于机架(未示出)上,压板4211沿竖直方向的厚度均匀,可相对于机架沿斜向下的方向移动,即压板4211相对于平面微针1从第三侧壁123与压板4211的接触点指向针尖124的方向倾斜向下移动,相对于水平方向,倾斜角30°≤α≤60°。压板4211沿第三侧壁123与压板4211的接触点指向针尖124的方向倾斜向下移动,当压板4211接触第三侧壁123形成接触点并向第三侧壁123施压时,给予第三侧壁123一个由接触点指向针尖124的分力,从而使微针12绕边1231旋转。随着压板4211继续下压,第三侧壁123受到压板4211沿水平方向的分力和竖直向下的分力,从而使微针12继续绕第一边1231旋转,直至第三侧壁123与基底层11大致处于同一平面或者部分抵靠基底层11,即第三侧壁123与基底层11所在平面间的夹角为0°~±10°,完成平面微针1的立形。当α<30°时,压板4211下移至与微针12接触时需要移动较大的距离,若压板4211面积与平面微针1基本一致,则当压板4211完全压接至平面微针1的基底层11表面时,部分微针12位于压板4211外,压板4211无法与该部分微针12接触并向其施压,无法彻底完成立形;若压板4211面积远大于平面微针1,能实现平面微针1上的所有微针12立形,但相同长度流水线放置的平面微针1的数量则相对减少,降低生产效率,间接增加生产成本。当α>60°时,压板4211完全压接于基底层11表面后,先于压板4211接触的基底层11因受力较大,易导致变形而造成坏品,间接增加生产成本。
参照图26-27,优选地,压板4211的底部设置多个施压部42111,施压部42111和容纳槽4221一一对应地设置。施压部42111的纵向截面为向下突出的弧形、V字型或矩形等其他能够向微针12施压的形状。施压部42111的纵向截面优选为向下突出的弧形或V字型,以在施压部42111向微针12施压时,施压部42111的形状和微针12的第三侧壁123受压形变后的形状相匹配,进而使微针12的第三侧壁123均匀受力,避免微针12受损。
当微针12未设置凸起部127时,压板4211的材质和施压部42111的材质优选为弹性材质,例如橡胶或硅胶,以在压板4211或施压部42111向微针12施压时,压板4211或施压部42111能够发生形变并陷入容纳槽4221内,为微针12提供足够的翻转压力,以将微针12由第一侧壁121与基底层11位于同一平面翻转至第三侧壁123倾斜于基底层11靠近微针12的一侧,进而在微针12回弹后,微针12的第三侧壁123能够与基底层11大致处于同一平面或者部分抵靠基底层11,即第三侧壁123与基底层11所在平面间的夹角为0°~±10°,完成微针12立形。
当微针12设置凸起部127时,由于压板4211或施压部42111仅需将微针12翻转至将凸起部127和基底层11远离微针12的一侧齐平,所需的翻转力较小,因此,压板4211或施压部42111的材质不限,可以为刚性材质或弹性材质,减小了压板4211和施压部42111的选材难度。
进一步,压板4211完成微针12立形后需要制备设有粘性层21的微针贴2时,微针容纳机构422优选还包 括多组间隔设置的固定板组件。固定板组件用于防止压板4211复位离开且不再压合平面微针1时,微针12在无外力作用下绕第一边1231沿立形的反方向旋转,导致第三侧壁123与基底层11成一定夹角,粘合粘性层21时第三侧壁123与粘性层21之间的气体无法完全排出而形成褶皱,造成坏品。
每个固定板组件包括第一夹持板4222和第二夹持板4223。第一夹持板4222能够沿平行于基底层11方向向靠近或远离第二夹持板4223移动。第一夹持板4222抵靠在同组固定板组件的第二夹持板4223上时,第一夹持板4222和第二夹持板4223之间形成容纳槽4221。微针12立形后,微针12位于容纳槽4221内时,第一夹持板4222和第二夹持板4223容纳夹持微针12。为更好的描述说明,下文中以第一夹持板4222位于第二夹持板4223的左侧为例进行描述。
参照图18-24,固定板组件的具体工作原理如下:
初始状态时,第一夹持板4222远离同组固定板组件的第二夹持板4223,第一夹持板4222和第二夹持板4223之间形成容纳槽4221,此时容纳槽4221的空间较大,微针12可在容纳槽4221中自由的旋转而不受第一夹持板4222阻挡。平面微针传送带4111将平面微针1传送至微针容纳机构422的顶部,并使平面微针1上的多排微针12和微针容纳机构422的顶部的多个容纳槽4221一一对应地设置。
压板4211向平面微针1上的全部微针12施压,微针12由微针12的第一侧壁121与基底层11位于同一平面翻转至微针12的第三侧壁123与基底层11大致处于同一平面或者部分抵靠基底层11即第三侧壁123与基底层11所在平面间的夹角为0°~±10°,此时,微针12位于容纳槽4221内。随后,多个第一夹持板4222同步右移与第二夹持板4223之间形成空间等于或略大于微针12所占空间的容纳槽4221,使微针12位于容纳槽4221内且受第一夹持板4222阻挡无法绕第一边1231沿立形的反方向旋转。当压板4211复位而离开平面微针1的压合位置时,微针12仍能保持第三侧壁123与基底层11大致处于同一平面或者部分抵靠基底层11即第三侧壁123与基底层11所在平面夹角为0°~±10°的状态,避免微针12粘附粘性层21时发生移位导致粘贴不牢或者粘性层21起皱。
具体地,微针容纳机构422上设置驱动结构,驱动结构用于驱动第一夹持板4222移动。
参照图28-32,进一步,当翻转机构包括第一滚轮4212时,第一滚轮4212压合在平面微针1上,第一滚轮4212用于向微针12施压,以使微针12由微针12的第一侧壁121与基底层11位于同一平面翻转至第三侧壁123与基底层11大致处于同一平面或者部分抵靠基底层11,即第三侧壁123与基底层11所在平面夹角为0°~±10°,完成微针12立形,此时:
第一滚轮4212和微针容纳机构422能够相向移动,具体为:第一滚轮4212绕第一滚轮4212的固定轴转动,微针容纳机构422随立形传送带4112(未示出)沿远离平面微针传送带4111方向移动;或微针容纳机构422固定位置,第一滚轮4212绕第一滚轮4212的支撑轴相对于微针容纳机构422滚动;又或微针容纳机构422随立形传送带4112(未示出)沿远离平面微针传送带4111方向移动,第一滚轮4212绕第一滚轮4212的支撑轴滚动并沿靠近平面微针传送带4111方向水平移动。
优选的,第一滚轮4212绕第一滚轮4212的固定轴滚动,微针容纳机构422随立形传送带(未示出)向远离平面微针传送带4111方向水平移动,减少相对移动的元素,简化设备控制要素,简化工艺。参照图29,第一滚轮4212位于平面微针1的微针12的第三侧壁123相对一侧,微针容纳机构422随立形传送带(未示出)沿远离平面微针传送带4111方向移动,第一滚轮4212沿逆时针方向转动,第一滚轮4212表面压接第三侧壁123,给予第三侧壁123施加沿水平方向朝向平面微针传送带4111的分力及竖直向下的分力,使微针12绕第一边1231旋转,直至第三侧壁123与基底层11大致处于同一平面或者部分抵靠基底层11即第三侧壁123与基底层11所在平面夹角为0°~±10°,完成平面微针1的立形。第一滚轮4212逐排向微针12施压,以使微针12逐排立形。因第一滚轮4212的转动方向与微针12的旋转方向相同,微针12的第三侧壁123受到第一滚轮4212的压合力转化为使微针12旋转的力,从而避免微针12在立形过程中因受力而受损,保证产品的良品率。
进一步,第一滚轮4212完成微针12立形后需要制备设有粘性层21的微针贴2时,翻转机构还包括滚轮组件,滚轮组件设置于机架(未示出)上,滚轮组件包括第二滚轮4213和第三滚轮4214。
第二滚轮4213上绕设粘性层21,第二滚轮4213用于向第一滚轮4212传送粘性层21。粘性层21设有保护膜的一面背离第一滚轮4212、第二滚轮4213的转轴。第一滚轮4212靠近第三滚轮4214一侧设有保护膜剥离结构,保护膜剥离结构用于控制由粘性层21上剥离保护膜的剥离位置,第三滚轮4214用于缠绕并储存由第一滚轮4212上粘性层21撕除得到的保护膜,该保护膜用于避免粘性层21缠绕时相互粘合而无法使用。当粘 性层21保护膜撕除后,具有粘性的一面面向平面微针1的基底层11。第一滚轮4212用于向微针12施压,以使微针12由微针12的第一侧壁121与基底层11位于同一平面翻转至第三侧壁123与基底层11大致处于同一平面或者部分抵靠基底层11即第三侧壁123与基底层11所在平面间的夹角为0°~±10°,完成微针12立形,同时,第一滚轮4212还能将粘性层21粘附于基底层11远离微针12的一侧以及微针12的第三侧壁123或者凸起部127上,以制备为设有粘性层21的微针贴2。
此时,微针容纳机构422能够带动平面微针1向远离平面微针传送带4111的方向移动。
第一滚轮4212和微针容纳机构422能够相向移动,实现微针12逐排立形,并将粘性层21逐排粘附在基底层11远离微针12的一侧以及微针12的第三侧壁123或凸起部127上,以成型为设有粘性层21的微针贴2。在此过程中,粘性层21能够逐排粘附在基底层11以及微针12的第三侧壁123或凸起部127上,以完全排出基底层11和粘性层21、微针12的第三侧壁123或凸起部127与粘性层21之间的空气,避免成型后的微针贴2起皱。同时,微针12的第三侧壁123或者凸起部127粘附于粘性层21后,在基底层11和粘性层21间的粘附力的牵引下,与微针12的第三侧壁123或者凸起部127接触处的粘性层21平整无皱,提高了成型后的微针贴2的良品率。
进一步,第一滚轮4212优选为弹性材质,例如橡胶或硅胶,以在第一滚轮4212向微针12施压时,第一滚轮4212能够发生形变并陷入容纳槽4221内,为微针12提供足够的翻转压力,以将微针12由微针12的第一侧壁121与基底层11位于同一平面翻转至微针12的第三侧壁123倾斜于基底层11靠近微针12的一侧,进而在微针12回弹后,微针12的第三侧壁123与基底层11大致处于同一平面或者部分抵靠基底层11,即第三侧壁123与基底层11所在平面间的夹角为0°~±10°,完成微针12立形。
进一步,当翻转机构包括压板4211,且需要制备设有粘性层21的微针贴2时,或者,翻转机构包括第一滚轮4212,且需要制备设有粘性层21的微针贴2时:本平面微针的立形装置还包括粘性层黏贴机构。
粘性层黏贴机构包括抓取件和视觉识别器。微针12立形后,翻转机构移开,抓取件通过视觉识别器将粘性层21对应贴合于基底层11远离微针12的一侧。随后,翻转机构向粘性层21施压,以将粘性层21稳定粘附于基底层11远离微针12的一侧以及微针12的第三侧壁123或凸起部127上,以成型为设有粘性层21的微针贴2。
抓取件优选为真空吸附抓取装置。
更具体地,粘性层黏贴机构还包括粘性层传送器和暂存台,粘性层传送器用于去除粘性层21上的保护膜,并将粘性层21传送至暂存台,暂存台用于存储粘性层21,并供抓取件逐个抓取。其中,保护膜用于避免粘性层21发生粘贴。
实施例6
参照图35-图43所示,在实施例1-2的基础上,本实施例还提供另一种平面微针立形装置,用于将平面微针1粘附于粘性层21上以成型为微针贴2。平面微针立形装置包括平面微针传送组件41和平面微针翻转组件42。
平面微针传送组件41用于传送平面微针1和粘性层21。平面微针翻转组件42位于平面微针1和粘性层21的连接处。平面微针翻转组件42用于将基底层11粘附于粘性层21上,并将微针12与基底层11位于同一平面的第一侧壁121翻转至第三侧壁123与基底层11大致处于同一平面或者部分抵靠于基底层11,且使第三侧壁123黏附于粘性层21上,以完成微针立形。
平面微针传送组件41包括平面微针传送带4111和立形传送带4112。平面微针传送带4111倾斜设置,用于传送平面微针1。立形传送带4112水平设置,且位于平面微针传送带4111的下端,立形传送带4112用于传送具有粘性的粘性层21,并接受来自平面微针传送带4111的平面微针1。平面微针翻转组件42位于平面微针传送带4111的下端附近。
在立形过程中,倾斜设置的平面微针传送带4111能够将平面微针1以逐步接触立形传送带4112上的粘性层21的方式,将平面微针1传送至该粘性层21上,如此能够确保平面微针1和粘性层21平整粘合,二者间不存在气泡或空鼓起皱现象。平面微针翻转组件42用于将平面微针1的基底层11粘附于粘性层21,并使平面微针1的微针12绕第三侧壁123与基底层11的连接处旋转,由与基底层11位于同一平面的第一侧壁121翻转至第三侧壁123与基底层11大致处于同一平面或者部分抵靠于基底层11,实现微针12立形,随后,微针12的底部粘附于粘性层21上,平面微针1和粘性层21结合为微针贴2。
本平面微针立形装置适用于两步式成型的微针贴2,先通过微针模具32成型为平面微针1,再由平面微针立形装置将平面微针1粘附于粘性层21上,并将微针12调整至第三侧壁123与基底层11大致处于同一平面或者部分抵靠于基底层11,进而粘附于粘性层21上。
进一步,平面微针翻转组件42向平面微针1施加用于使平面微针1粘附于粘性层21的力,该力的方向优选为垂直于立形传送带4112的传送方向。在操作过程中,平面微针翻转组件42向平面微针1施加的力逐排/逐步作用在平面微针1上,以使平面微针1的基底层11逐排粘附于粘性层21上,平面微针1逐步/逐排粘附于粘性层21的过程中,平面微针1上的微针12受到来自粘性层21的反作用力,在该反作用力的作用下,每排微针12能够同时绕第三侧壁123各自与基底层11的连接处旋转,以使与基底层11位于同一平面的第一侧壁121翻转至第三侧壁123与基底层11大致处于同一平面或者部分抵靠于基底层11,且使第三侧壁123黏附于粘性层21上,以完成微针立形。随后,微针12的第三侧壁123粘附于粘性层21,实现平面微针1与粘性层21结合为微针贴2。在此过程中,基底层11和粘性层21间逐排接触以逐步实现基底层11与粘性层21结合的方式,能够完全排出基底层11和粘性层21之间的空气,由于平面微针传送带4111与立形传送带4112具有一定的夹角,微针12第三侧壁123的尺寸与其投影于粘性层21上的尺寸相近,且微针12第三侧壁123与粘性层21逐层粘合,微针12第三侧壁123尺寸L1相对于其在粘性层21上的投影尺寸L2差值较小,且基底层11和粘性层21均具有一定的弹性,故能避免立形时,所有微针12第三侧壁123与粘性层21同时粘合尺寸差余量差值累积,而导致的成型后的微针贴2起皱。同时,微针12旋转至第三侧壁123粘附于粘性层21后,在基底层11和粘性层21间粘附力的牵引下,能够使与微针12的第三侧壁123接触处的粘性层21平整无皱,以提高成型后的微针贴2的良品率。
进一步,沿立形传送带4112的传送方向,平面微针翻转组件42间隔设置至少一个,以在靠近平面微针传送带4111的平面微针翻转组件42将平面微针1粘附于粘性层21上后,其余平面微针翻转组件42能够持续向微针贴2施加力,以使平面微针1和粘性层21之间的结合更加牢固。
进一步,平面微针翻转组件42可以为如下几种类型:
参照图35-图37所示,平面微针翻转组件42可以为真空负压吸附黏合件423。真空负压吸附黏合件423设置在立形传送带4112的下方。真空负压吸附黏合件423用于向平面微针1施加垂直于立形传送带4112传送方向的负压气流,在该负压气流的吸附力作用下,平面微针1粘附于粘性层21以成型为微针贴2。
此时,立形传送带4112和粘性层21上均设置供气流通过的网格状通孔。
参照图38-图40所示,平面微针翻转组件42可以为风压黏合件424。风压黏合件424设置在立形传送带4112的上方。风压黏合件424能够向平面微针1施加垂直于立形传送带4112传送方向的气流,在该气流的粘附压力作用下,平面微针1粘附于粘性层21以成型为微针贴2。
此时,立形传送带4112可以为网状平面或者为无孔平面,粘性层21为无孔平面。
参照图41-图43所示,平面微针翻转组件42可以为滚轮接触压合件425。滚轮接触压合件425包括至少一个间隔设置的滚轮4251,至少一个滚轮4251的轴向垂直于立形传送带4112的传送方向,且每个滚轮4251用于滚动设置在平面微针1的每排微针12中相邻两个微针12之间的基底层11上,以逐步/逐排向基底层11施加压力,并使粘性层21形成用于逐步/逐排向微针12施加的反作用力,进而使平面微针1粘附于粘性层21成型为微针贴2。由于滚轮4251与平面微针1之间的压合面积较小,压强较大,能够使基底层11以及微针12的底部分别与粘性层21间的粘合更加牢固。
滚轮接触压合件425还包括支撑架4252,滚轮4251转动设置在支撑架4252上。
优选地,平面微针传送带4111的延伸方向和立形传送带4112的延伸方向间的夹角为135°-179°。当平面微针传送带4111的延伸方向和立形传送带4112的延伸方向间的夹角小于135°时,容易导致平面微针1粘附于粘性层21时,平面微针1与粘性层21之间的夹角太大,导致真空负压吸附黏合件423和风压黏合件424向平面微针1施加的气流作用于平面微针1上的力分解成平行于粘性层21的水平方向分力增加,而垂直于粘性层21的竖直方向分力减小,造成:无法将平面微针1的基底层11压送至粘性层21表面,基底层11与粘性层21无法贴合粘附,或基底层11与粘性层21之间的粘附力不足,基底层11与粘性层21无法实现完全贴合。因作用在平面微针1上的竖直方向的分力不足,基底层11与粘性层21无法粘附或完全粘附,粘性层21产生用于旋转微针12的反作用力小,使得微针12无法旋转或者无法完全旋 转。滚轮接触压合件425压合立形时,滚轮4251与未传送至立形传送带4112上的平面微针1接触而损伤微针12。当平面微针传送带4111的延伸方向和立形传送带4112的延伸方向间的夹角大于179°时,由于平面微针传送带4111与立形传送带4112几乎平行,微针12在立形时,所有微针12的底部与粘性层21同时粘合,多个微针12第三侧壁尺寸L1与其投影于粘性层21上的尺寸L2的差值L1-L2累积后的数值较大,导致成型后的微针贴2起皱,成为不良品。
进一步,平面微针传送带4111的下端设置用于供平面微针1通过的挡板414,挡板414为平面微针1的传送起导向作用。挡板414包括第一挡板4141和第二挡板4142,第一挡板4141和第二挡板4142相对设置在平面微针传送带4111的两侧。
进一步,本平面微针立形装置还包括储料器412,储料器412位于平面微针传送带4111的上方,且位于平面微针传送带4111的上端,储料器412用于存储上下堆叠设置的平面微针1。
储料器412的底部设置用于排出平面微针1的出料口。出料口具体为:形状与平面微针1相似且面积小于平面微针1,以存储平面微针1。出料口与平面微针传送带4111平行设置,且出料口与平面微针传送带4111的间距大于平面微针1的厚度。
进一步,本平面微针立形装置还包括平面微针吸附器413。平面微针吸附器413贯穿平面微针传送带4111设置,且平面微针吸附器413位于储料器412中的平面微针1中心处的下方。平面微针吸附器413能够排出脉冲的负压气流,以逐层将平面微针1由出料口吸附并平铺至平面微针传送带4111上,平面微针吸附器413可在轴线方向上移动,平面微针吸附器413能够穿过平面微针传送带4111并靠近储料器412底部,以排出脉冲的负压气流,当平面微针1由储料器412吸出至平面微针传送带4111上时,平面微针吸附器413停止排出脉冲的负压气流,并沿轴线方向退回至平面微针传送带4111的下方,具体过程如下:
由于平面微针吸附器413位于储料器412中的平面微针1中心处的下方,平面微针吸附器413向平面微针1施加的吸附力作用于平面微针1的中心处,平面微针1变形后由出料口排出,平面微针1的中心处先贴附于平面微针传送带4111上,随后,吸附力在平面微针1的边缘处形成拉力,在该拉力的作用下,平面微针1的边缘处延展并平铺于平面微针传送带4111上,以实现将平面微针1由储料器412中移送并平铺至平面微针传送带4111上。
本发明的平面微针的立形装置结构简单,便于加工,而且立形方法快捷高效。
在本说明书的描述中,术语“一个实施例”、“一些实施例”、“实施例”、“示例”、“具体示例”或“一些示例”等的描述,是指结合该实施例或示例描述的具体特征、结构、材料或者特点包含于本发明的至少一个实施例或示例中。在本说明书中,对上述术语的示意性表述不必须针对的是相同的实施例或示例。而且,描述的具体特征、结构、材料或者特点可以在任一个或多个实施例或示例中以合适的方式结合。此外,在不相互矛盾的情况下,本领域的技术人员可以将本说明书中描述的不同实施例或示例以及不同实施例或示例的特征进行结合和组合。
尽管上面已经示出和描述了本发明的实施例,可以理解的是,上述实施例是示例性的,不能理解为对本发明的限制,本领域的普通技术人员在本发明的范围内可以对上述实施例进行改动、修改、替换和变型。

Claims (23)

  1. 一种平面微针,其特征在于,包括基底层(11)和可翻转设置在所述基底层(11)上的微针(12),所述微针(12)包括针尖(124)、针座(126)和连接所述针尖(124)和所述针座(126)的中部(125),所述针尖(124)朝向所述针座(126)的方向与所述基底层(11)延伸方向相同;所述平面微针(1)由原料液填充干燥成型。
  2. 根据权利要求1所述的平面微针,其特征在于,所述微针(12)包括第一侧壁(121)、周向侧壁和第三侧壁(123),所述第一侧壁(121)和所述周向侧壁位于所述微针(12)的周向,所述第三侧壁(123)位于所述微针(12)的底部;所述第一侧壁(121)和所述基底层(11)位于同一平面,所述第三侧壁(123)连接所述基底层(11),所述微针(12)能够绕所述第三侧壁(123)与所述基底层(11)的连接处翻转。
  3. 根据权利要求2所述的平面微针,其特征在于,所述第三侧壁(123)包括第一边(1231),所述第一边(1231)连接所述基底层(11)远离第一侧壁(121)一侧;所述微针(12)可绕所述第一边(1231),以所述第三侧壁(123)朝向所述第一侧壁(121)的方向,旋转至所述第三侧壁(123)与基底层(11)所在平面间的夹角为0°~±10°,所述微针(12)与所述基底层(11)的相接处形成基底通孔(112)。
  4. 根据权利要求3所述的平面微针,其特征在于,所述微针(12)可绕所述第一边(1231)旋转至所述第三侧壁(123)部分抵靠在所述基底层(11)靠近所述微针(12)的一侧,第三侧壁(123)包括与所述第一边(1231)连接的活动边,所述活动边与所述基底通孔(112)侧壁间的夹角θ的取值范围为0°<θ≤10°。
  5. 根据权利要求1-4任一所述的平面微针,其特征在于,所述微针(12)沿垂直于所述基底层(11)的最大深度和沿平行于所述基底层(11)的最大长度的比值为1:5~1:2。
  6. 一种微针贴,其特征在于,所述微针贴包括如权利要求1-5任一所述的平面微针(1)。
  7. 根据权利要求6所述的微针贴,其特征在于,所述微针贴还包括粘性层(21);所述微针(12)包括第一侧壁(121)、周向侧壁和第三侧壁(123),所述第一侧壁(121)和所述周向侧壁位于所述微针(12)的周向,所述第三侧壁(123)位于所述微针(12)的底部;所述第一侧壁(121)和所述基底层(11)位于同一平面,所述第三侧壁(123)连接所述基底层(11),所述微针(12)能够绕所述第三侧壁(123)与所述基底层(11)的连接处翻转,使所述微针(12)和所述基底层(11)远离所述微针(12)的一侧均粘附于所述粘性层(21)。
  8. 一种平面微针制造设备,应用于制造如权利要求1-5任一所述的平面微针(1),其特征在于,
    包括底座(31)、模具(32)和位于所述底座(31)上方的面板(33);
    所述底座(31)的顶部设置用于容纳所述模具(32)的凹槽(311);
    所述模具(32)的顶部设置多个内凹用于成型微针(12)的成型槽(321);
    所述成型槽(321)包括针尖槽(3212)、针座槽(3214)和中部槽(3213),所述中部槽(3213)连通所述针尖槽(3212)和所述针座槽(3214),所述针尖槽(3212)朝向所述针座槽(3214)的方向为水平方向;
    所述面板(33)上设有用于容纳所述模具(32)的全部所述成型槽(321)的成型孔(331),所述成型孔(331)用于成型基底层(11);
    所述模具(32)的顶部向上突出形成隔离部(322),所述隔离部(322)围绕所述成型槽(321)的侧壁的周向设置;当所述模具(32)嵌合于所述底座(31)的所述凹槽(311)内,所述面板(33)压合于所述底座(31)和所述模具(32)的顶部时,所述隔离部(322)的高度大于或等于面板(33)的高度。
  9. 根据权利要求8所述的平面微针制造设备,其特征在于,沿所述成型槽(321)的所述针尖槽(3212)朝向针座槽(3214)的方向,所述成型槽(321)底壁向外延伸形成凸起部形成槽(3215),所述凸起部形成槽(3215)用于成型所述微针(12)的第三侧壁(123)上的凸起部(127)。
  10. 根据权利要求8所述的平面微针制造设备,其特征在于,所述成型槽(321)的成型槽底壁(3211)的下边绕所述成型槽底壁(3211)的上边旋转至所述成型槽底壁(3211)抵靠所述模具(32)的顶部时,所述下边的长度大于所述下边与所述成型槽(321)的两个交点的连线长度。
  11. 一种平面微针制备方法,采用如权利要求8-10任一所述的平面微针制造设备,其特征在于,包括如下步骤:
    A1:组装底座(31)、模具(32)和面板(33);
    A2:向所述模具(32)的针尖槽(3212)内注入载药液,干燥为所述微针(12)的所述针尖(124);
    A3:向所述模具(32)的中部槽(3213)、针座槽(3214)和所述面板(33)的成型孔(331)内注入原料液后,沿所述面板(33)的顶部刮平原料液;
    所述成型孔(331)内的原料液干燥为所述基底层(11),所述模具(32)的针座槽(3214)内的原料液干燥为所述微针(12)的所述针座(126),所述模具(32)的中部槽(3213)内的原料液干燥为所述微针(12)的所述中部(125)。
  12. 根据权利要求11所述的平面微针制备方法,其特征在于,步骤A3中还包括:
    向所述面板(33)的所述成型孔(331)内注入原料液后,沿所述模具(32)的所述针尖槽(3212)朝向所述针座槽(3214)的方向刮平所述载药液;
    或者,向所述面板(33)的所述成型孔(331)内注入原料液至布满所述成型孔(331),沿所述面板(33)的顶部刮平原料液后,抽真空;
    或者,向所述面板(33)的所述成型孔(331)内注入原料液至布满所述成型孔(331),沿所述面板(33)的顶部刮平原料液后,离心。
  13. 一种平面微针立形设备,应用于立形如权利要求1-5任一项所述的平面微针,其特征在于,包括平面微针传送组件(41)和平面微针翻转组件(42);
    所述平面微针传送组件(41)包括平面微针传送带(4111),所述平面微针传送带(4111)用于将所述平面微针(1)传送至所述平面微针翻转组件(42);
    所述平面微针翻转组件(42)用于向所述平面微针(1)的微针(12)施压,以将微针(12)绕所述第三侧壁(123)与所述基底层(11)的连接处翻转,以使所述微针由第一侧壁(121)和所述基底层(11)位于同一平面翻转至所述第三侧壁(123)与基底层(11)所在平面间的夹角为0°~±10°,以完成微针(12)立形。
  14. 根据权利要求13所述的平面微针立形设备,其特征在于,所述平面微针翻转组件(42)为真空负压吸附黏合件(423),所述真空负压吸附黏合件(423)用于从微针(12)的下方向微针(12)施加负压气流;
    或者,所述平面微针翻转组件(42)为风压黏合件(424),所述风压黏合件(424)用于从微针(12)的上方向微针(12)施加气流;
    或者,所述平面微针翻转组件(42)为滚轮接触压合件(425),所述滚轮接触压合件(425)用于在所述平面微针(1)上滚动,以对所述微针(12)施加压力。
  15. 根据权利要求13所述的平面微针立形设备,其特征在于,所述平面微针翻转组件(42)包括翻转机构和微针容纳机构(422);所述翻转机构为压板(4211);
    所述翻转机构用于向所述微针(12)施压,以使所述微针(12)绕所述第一边(1231)旋转,至位于所述微针容纳机构(422)顶部的容纳槽(4221)内,以完成所述微针(12)立形。
  16. 根据权利要求15所述的平面微针立形设备,其特征在于,所述压板(4211)的底部设置多个施压部(42111),多个所述施压部(42111)和多个所述容纳槽(4221)一一对应地设置。
  17. 根据权利要求16所述的平面微针立形设备,其特征在于,所述施压部(42111)的纵向截面为向下突出的弧形或V字型。
  18. 根据权利要求14所述的平面微针立形设备,其特征在于,所述平面微针翻转组件(42)包括翻转机构和微针容纳机构(422);所述翻转机构包括第一滚轮(4212),所述第一滚轮(4212)用于向所述微针(12)施压,以使所述微针(12)绕所述第一边(1231)旋转,至位于所述微针容纳机构(422)顶部的容纳槽(4221)内,以完成所述微针(12)立形;
    所述第一滚轮(4212)和所述微针容纳机构(422)能够相向移动。
  19. 根据权利要求18所述的平面微针立形设备,其特征在于,所述翻转机构还包括第二滚轮(4213)和第三滚轮(4214);
    所述第二滚轮(4213)上绕设粘性层(21),所述第二滚轮(4213)用于向所述第一滚轮(4212)传送所述粘性层(21),所述第三滚轮(4214)用于缠绕并储存由所述第一滚轮(4212)上的所述粘性层(21)撕除得到的保护膜,所述第一滚轮(4212)用于向所述微针(12)施压,并将所述粘性层(21)粘附在所述基底层(11)远离所述微针(12)的一侧以及所述微针(12)上。
  20. 根据权利要求19所述的平面微针立形设备,其特征在于,所述第一滚轮(4212)上靠近所述第三滚轮(4214)的一侧设置保护膜剥离结构,所述保护膜剥离结构用于控制由所述粘性基底上剥离所述保护膜的位置。
  21. 根据权利要求15-17任一所述的平面微针立形设备,其特征在于,所述微针容纳机构(422)还包括多组间隔设置的固定板组件;
    所述固定板组件包括第一夹持板(4222)和第二夹持板(4223),所述第一夹持板(4222)能够沿靠近或远离第二 夹持板(4223)方向移动;
    所述第一夹持板(4222)抵靠在所述第二夹持板(4223)上时,所述第一夹持板(4222)和所述第二夹持板(4223)之间形成所述容纳槽(4221);
    所述微针(12)位于所述容纳槽(4221)内时,所述第一夹持板(4222)和所述第二夹持板(4223)夹持所述微针(12)。
  22. 根据所述权利要求15-20任一所述的平面微针立形设备,其特征在于,所述微针容纳机构远离所述平面微针传送组件(41)的一端设置限位板(4224),所述平面微针(1)抵靠在所述限位板(4224)上。
  23. 根据权利要求13-20任一项所述的平面微针立形设备,其特征在于,所述平面微针传送组件(41)还包括立形传送带(4112);所述平面微针传送带(4111)倾斜设置,用于传送所述平面微针(1),所述立形传送带(4112)水平设置,且位于所述平面微针传送带(4111)的下端,所述立形传送带(4112)用于传送具有粘性的粘性层(21)或微针容纳机构(422),并接受来自所述平面微针传送带(4111)的所述平面微针(1);
    所述平面微针传送带(4111)的延伸方向和所述立形传送带(4112)的延伸方向间的夹角为135°-179°。
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