CN216127597U

CN216127597U - Apparatus for preparing microneedles

Info

Publication number: CN216127597U
Application number: CN202121753612.XU
Authority: CN
Inventors: 陈宾文; 颜平; 黄远; 刘龙; 曲秋羽
Original assignee: Shanghai Yuefuda Biotechnology Co ltd; Suzhou Reveda Medical Biotech Co Ltd
Current assignee: Shanghai Yuefuda Biotechnology Co ltd; Suzhou Reveda Medical Biotech Co Ltd
Priority date: 2021-07-28
Filing date: 2021-07-28
Publication date: 2022-03-25
Anticipated expiration: 2031-07-28

Abstract

The utility model relates to equipment for preparing a microneedle, which comprises a microneedle female die, a vacuum chamber, a filling mechanism and a vacuumizing mechanism, wherein the vacuum chamber comprises a feeding cavity, a filling cavity and a discharging cavity which are mutually and independently arranged; the feeding cavity is used for receiving the microneedle female die in a non-negative pressure state, the vacuumizing mechanism is used for vacuumizing the feeding cavity which has received the microneedle female die, the filling cavity is used for receiving the microneedle female die transferred from the feeding cavity in a negative pressure state, and the discharging cavity is used for receiving the microneedle female die transferred from the filling cavity in the negative pressure state and breaking vacuum after receiving the microneedle female die. The utility model can realize mass production of the micro-needle, improve the preparation efficiency of the micro-needle and ensure the forming quality of the micro-needle.

Description

Apparatus for preparing microneedles

Technical Field

The utility model belongs to the technical field of microneedle preparation, and particularly relates to equipment for preparing microneedles.

Background

Most therapeutic agents are delivered to the body by subcutaneous injection, which is a low cost, rapid and straightforward way of administering the drug. Patients themselves, however, do not have the ability to use syringes with greater ease, and the pain and fear associated with syringes further limit patient compliance. Microneedles (including needles with micron-sized dimensions) are loaded with drugs and administered transdermally, which is one of the solutions to the above-mentioned problems. The microneedle transdermal drug delivery mode can realize drug delivery without pain, and improves the compliance and safety of patients. Meanwhile, the micro-needle can realize quantitative and positioning delivery of medicaments and the like, can realize accurate administration and has good administration effect. In addition to this, microneedles can also be used as a skin pretreatment, with the ability to enhance skin permeability. Therefore, the microneedle has better clinical application prospect.

The polymer micro-needle patch utilizes the polymer micro-needle to puncture the human stratum corneum to form a channel which is beneficial to drug delivery, thereby promoting the transdermal absorption of the drug. The current technical route for manufacturing the polymer micro-needle is as follows: preparing a polymer solution for preparing the microneedles, filling the polymer solution into a microneedle female die with a groove, curing and molding the polymer solution in the microneedle female die, and finally demolding to obtain the soluble microneedles. The method which is commonly adopted in the technical route at present is a method of silicone elastic female die transfer. The method specifically comprises the following steps: firstly, preparing a silica gel elastic female die with a groove in advance (the groove is in a microneedle shape); then coating the prepared polymer solution on the surface of a silica gel elastic female die with a groove, and placing the silica gel elastic female die in a vacuum environment for a certain time; after the polymer solution completely fills the grooves of the silicone elastic female mold, the silicone elastic female mold is placed in the natural environment and is solidified by a certain method (such as drying and crosslinking), and finally the soluble microneedles are formed.

The most critical step of the preparation method is to fill the polymer solution into the silica gel elastic female die with the groove. Because the size of the groove in the silica gel elastic female die is small (partial area is even only a few micrometers), if the silica gel elastic female die is independently filled one by one, the efficiency is low, the requirement on equipment is extremely high, and the silica gel elastic female die is very unfavorable for batch production. And the liquid filling can solve the problem of mass production. If the filling mode is adopted to fill the micro grooves together, after the surface of the silica gel elastic female die is covered by the polymer solution, the gas retained in the grooves below the liquid level can prevent the polymer solution from seeping into the grooves, thereby influencing the forming quality of the soluble microneedles.

In order to solve the technical problems, the prior art proposes that an empty microneedle female die is pretreated, namely, plasma gas is utilized to improve the hydrophilic property of the surface of the die, so as to achieve the purpose of promoting polymer solution to be filled into a microneedle groove. However, the hydrophilic property of the microneedle negative mold pretreated by plasma gas is reduced with time. Therefore, under the influence of the residence time of the pretreated microneedle female die, the difference of the hydrophilic performance between the dies and in different areas in the dies is large, so that the filling of the grooves in the microneedle female die is influenced, the forming consistency and stability of soluble microneedles are further influenced, and the forming quality of the soluble microneedles is difficult to ensure.

The prior art also provides that under negative pressure, cover polymer solution to micropin bed die surface, utilize atmospheric pressure to fill polymer solution in the recess afterwards, can accomplish the even pouring of big plane micropin casting mold fast, realize the high accuracy of micro-nano structure and duplicate fast, however, can't satisfy mass production's requirement, and production efficiency is low, and still be difficult to guarantee the stability of vacuum filling environment, influence the shaping quality of micropin, simultaneously nimble relatively poor, can't be applicable to the micropin mould of not unidimensional, lead to needing dismouting repeatedly, complex operation. In addition, the prior art still has the problem that the homogenization treatment effect is poor to microneedle bed die surface solution, and homogenization treatment can pollute the solution to and can't fully get rid of the interior air of recess during the casting solution, finally be difficult to effectual assurance microneedle shaping quality. In addition, the preparation of soluble microneedles has problems of low automation, low production efficiency, high labor cost, and the like.

SUMMERY OF THE UTILITY MODEL

The utility model aims to provide equipment for preparing microneedles, which can realize mass production of the microneedles, improve the productivity of microneedle preparation, improve the production efficiency and improve the forming quality of the microneedles.

In order to achieve the aim, the utility model provides equipment for preparing microneedles, which comprises a microneedle female die, a vacuum chamber, a filling mechanism and a vacuumizing mechanism; a groove matched with the microneedle body is formed on the surface of the microneedle female die; the filling mechanism is at least partially arranged in the vacuum chamber and is used for releasing the solution for preparing the micro-needle; the vacuumizing mechanism is connected with the vacuum chamber and is used for vacuumizing the vacuum chamber; the vacuum chamber comprises a feeding cavity, a filling cavity and a discharging cavity which are mutually independent;

the feeding cavity is used for receiving the microneedle female die in a non-negative pressure state;

the vacuumizing mechanism is used for vacuumizing the feeding cavity which receives the microneedle female die;

the filling cavity is used for receiving the microneedle female die transferred by the feeding cavity in a negative pressure state;

the discharging cavity is used for receiving the microneedle female die transferred from the filling cavity in the negative pressure state and breaking vacuum after receiving the microneedle female die.

Optionally, the apparatus further comprises a controller and a vacuum breaking valve in communication connection, the vacuum breaking valve comprising a first vacuum breaking valve and a third vacuum breaking valve; the first vacuum breaking valve is arranged on the feeding cavity, and the third vacuum breaking valve is arranged on the discharging cavity;

the controller is used for controlling the first vacuum breaking valve to be opened so as to break vacuum in the feeding cavity, and is also used for controlling the third vacuum breaking valve to be opened so as to break vacuum in the discharging cavity after the microneedle female die in the third state is transferred to the discharging cavity in a negative pressure state.

Optionally, the controller is further in communication connection with the vacuum pumping mechanism; the controller is used for controlling the vacuumizing mechanism to vacuumize the discharging cavity, the filling cavity and the feeding cavity.

Optionally, the device further comprises a sensor assembly communicatively coupled to the controller, the sensor assembly comprising a first sensor, a second sensor, and a third sensor;

the feeding cavity is provided with the first sensor, the filling cavity is provided with the second sensor, the discharging cavity is provided with the third sensor, and the controller is used for controlling the vacuum degree of the corresponding cavity according to the pressure information detected by the first sensor, the second sensor and the third sensor.

Optionally, the apparatus further comprises a homogenizing mechanism, and a pouring station and a homogenizing station are arranged in the filling cavity;

when the filling cavity is in a negative pressure state, the microneedle female die in the filling cavity is used for being arranged at the pouring station, and the filling mechanism is used for pouring the solution to the surface of the microneedle female die;

and the homogenizing mechanism is used for carrying out homogenizing treatment on the microneedle female die after the microneedle female die in the filling cavity is used for pouring the solution, so that the solution is uniformly filled on the surface of the microneedle female die.

Optionally, homogenization mechanism includes snatchs mechanism and actuating mechanism, it includes main shaft subassembly and centre gripping subassembly to snatch the mechanism, actuating mechanism includes servo motor and drive assembly, main shaft subassembly includes main shaft and base, the bottom of main shaft with base fixed connection, the centre gripping subassembly includes at least three jack catch, at least three the jack catch is in around on the base the axis evenly distributed of main shaft is used for the fixed tray of centre gripping, the tray loads the micropin bed die, servo motor is used for through the drive assembly drive the main shaft is rotatory, the axis of main shaft with the axis of recess is parallel.

Optionally, the driving mechanism further comprises a cylinder assembly, an elastic component and a turntable; the turntable is sleeved on the main shaft and can rotate relative to the main shaft, one end of the elastic component is connected with the main shaft, and the other end of the elastic component is connected with the turntable;

when the turntable is driven by the cylinder assembly to rotate towards a first direction, the elastic part stores elastic potential energy and all the clamping jaws move to a release position;

when the acting force of the cylinder assembly is relieved from the rotating disc, the elastic part releases elastic potential energy and drives the rotating disc to rotate towards the second direction, so that all the clamping claws move to the locking position.

Optionally, the homogenizing mechanism further comprises a pressing block fixed on the base and used for pressing against the turntable in the axial direction; the number of the pressing blocks is at least three.

Optionally, the clamping assembly further includes a guide rail, a slider, fixing seats and a limit pin, the guide rail is arranged along the radial direction of the base, the slider is slidably disposed on the guide rail, the fixing seats are fixed on the slider, each of the claws is fixed on a corresponding one of the fixing seats, the limit pin is fixed on the fixing seat, the turntable is provided with an arc-shaped limit groove, the limit pin is movably disposed in the limit groove, and the distance between the arc-shaped two ends of the limit groove and the center of the turntable is different;

when the turntable rotates towards the first direction, the limiting pin moves from the near end to the far end of the arc-shaped limiting groove and drives the clamping jaw to move outwards until the limiting pin abuts against and buckles the far end of the limiting groove;

when the turntable rotates towards the second direction, the limiting pin moves from the near end of the arc-shaped limiting groove to the far end and drives the clamping claw to move inwards until the limiting pin abuts against and is buckled with the near end of the limiting groove.

Optionally, the cylinder assembly includes a push rod, a fixing column is disposed on the turntable, and the push rod is used for pushing the fixing column to drive the turntable to rotate in the first direction.

Optionally, the apparatus further comprises a tray for loading the female microneedle mould and a transfer line for transferring the tray; the homogenizing mechanism is used for driving the tray to move so as to carry out homogenizing treatment on the microneedle female die, and the movement of the tray comprises at least one of horizontal rotation, horizontal movement, shaking and up-and-down swinging.

Optionally, the apparatus further comprises a tray for loading the negative microneedle mould, and the same tray can be loaded with negative microneedle moulds of different sizes.

Optionally, the equipment further comprises a feeding conveying line, a discharging conveying line and a transferring conveying line, wherein the feeding conveying line is arranged in the feeding area, and the discharging conveying line is arranged in the discharging area;

the feeding conveying line is used for conveying the trays to the feeding cavity, and the discharging conveying line is used for receiving the trays from the discharging cavity;

the transfer conveying line is used for receiving the empty pallets from the blanking conveying line and conveying the empty pallets to the loading area.

Optionally, the transfer conveyor line is disposed below the feeding conveyor line and the discharging conveyor line, and the apparatus further includes an automatic transfer mechanism for transferring the empty tray on the discharging conveyor line to the transfer conveyor line and for transferring the empty tray on the transfer conveyor line to the feeding conveyor line.

Optionally, the apparatus further comprises an automatic feeding mechanism and an automatic feeding mechanism arranged in the feeding area, wherein the automatic feeding mechanism is used for conveying the microneedle female die to a feeding station;

the automatic feeding mechanism is also used for taking the microneedle female die away from the feeding station and placing the microneedle female die on the tray on the feeding conveying line.

Optionally, the device further comprises an automatic blanking mechanism and a transfer tray, wherein the automatic blanking mechanism is arranged in the blanking area, and the automatic blanking mechanism is used for taking away the microneedle female die from the tray on the blanking conveying line and placing the microneedle female die on the transfer tray.

Optionally, the feeding cavity, the filling cavity and the discharging cavity are sequentially and adjacently arranged, a first gate is arranged at an inlet of the feeding cavity, an outlet of the feeding cavity and an inlet of the filling cavity share a second gate, an outlet of the filling cavity and an inlet of the discharging cavity share a third gate, and an outlet of the discharging cavity is provided with a fourth gate.

Optionally, the apparatus further comprises a first transfer line, a second transfer line and a third transfer line, the first transfer line being disposed in the feeding chamber, the second transfer line being disposed in the filling chamber, the third transfer line being disposed in the discharging chamber.

Optionally, the filling mechanism is configured to pour the solution onto the surface of the microneedle female mold in the filling cavity in a negative pressure state.

Above-mentioned equipment of preparation micropin is through the feeding chamber that mutual independence set up, filling chamber and ejection of compact chamber, the evacuation of micropin bed die has been realized, the separation of the process of vacuum filling and broken vacuum, make vacuum filling latency can very big reduction, improve whole vacuum filling efficiency, and before vacuum filling, the micropin bed die has had longer evacuation, very big reduction the air in the recess on micropin bed die surface, make solution can fill the recess completely, it is effectual to fill, can effectual assurance micropin's shaping quality, simultaneously still very big improvement beat of production, increase equipment productivity, realize the mass production of micropin.

According to the equipment for preparing the microneedles, the microneedle female die is filled in the vacuum cavity, so that the solution is poured, the air in the groove of the microneedle female die can be fully discharged, the solution is filled in the groove of the microneedle female die after the vacuum is broken, and the microneedle forming quality is ensured.

The equipment for preparing the microneedles carries out homogenization treatment on the solution on the surface of the microneedle female die through the homogenization mechanism, so that the viscous solution on the surface of the microneedle female die can be effectively flattened, the solution is uniformly and flatly paved on the surface of the microneedle female die, and the microneedle forming quality is further ensured. Especially, the homogenization treatment to the micropin bed die is realized through the rotation of homogenization mechanism, wherein the axis of rotation of main shaft and the depth direction (the axial of defining for the recess) parallel arrangement of the recess of micropin bed die, with the stickness solution on the rotatory shakeout micropin bed die that relies on the main shaft, then stickness solution relies on gravity to get into the recess of micropin bed die, the stickness solution on the usable shakeout micropin bed die surface of this mode centrifugal force is effectual, the homogenization is effectual, and direct contact solution not, the pollution to solution has been avoided, microneedle shaping quality has further been guaranteed.

Drawings

It will be appreciated by those skilled in the art that the drawings are provided for a better understanding of the utility model and do not constitute any limitation to the scope of the utility model. Wherein:

fig. 1 is a schematic front view illustrating the structure of an apparatus for preparing microneedles according to a preferred embodiment of the present invention;

FIG. 2 is a schematic top view of the external structure of a vacuum chamber provided in accordance with a preferred embodiment of the present invention;

FIG. 3 is a schematic view of the internal structure of a vacuum chamber according to a preferred embodiment of the present invention;

fig. 4 is a schematic top view of the structure of an apparatus for preparing microneedles according to a preferred embodiment of the present invention;

FIG. 5 is a front view of the homogenizing mechanism of the preferred embodiment of the present invention;

FIG. 6 is a front view of the spindle assembly and clamp assembly of the preferred embodiment of the present invention;

FIG. 7 is a perspective view of the spindle assembly and clamping assembly of the preferred embodiment of the present invention;

FIG. 8 is a top view of the spindle assembly and clamp assembly of the preferred embodiment of the present invention;

FIG. 9 is a schematic view of the ejection of the cylinder assembly with the jaws disengaged in accordance with the preferred embodiment of the present invention;

FIG. 10 is a schematic view of the cylinder assembly of the preferred embodiment of the present invention retracted to allow the jaws to grip under the tension spring;

FIG. 11 is a rotational speed-time graph of the homogenizing mechanism of the preferred embodiment of the present invention in operation.

Detailed Description

The present invention will now be described in more detail with reference to the accompanying schematic drawings, in which preferred embodiments of the utility model are shown, it being understood that one skilled in the art may modify the utility model herein described while still achieving the advantageous effects of the utility model. Accordingly, the following description should be construed as broadly as possible to those skilled in the art and not as limiting the utility model.

In the interest of clarity, not all features of an actual implementation are described. In the following description, well-known functions or constructions are not described in detail since they would obscure the utility model in unnecessary detail. It will of course be appreciated that in the development of any such actual embodiment, numerous implementation-specific details must be set forth in order to achieve the developer's specific goals, such as compliance with system-related and business-related constraints, which will vary from one implementation to another. Moreover, it will be appreciated that such a development effort might be complex and time-consuming, but would nevertheless be a routine undertaking for those of ordinary skill in the art.

The utility model is described in more detail in the following paragraphs by way of example with reference to the accompanying drawings. The advantages and features of the present invention will become more apparent from the following description. It is to be noted that the drawings are in a very simplified form and are not to precise scale, which is merely for the purpose of facilitating and distinctly claiming the embodiments of the present invention.

The utility model is further described below with reference to the following figures and examples.

Fig. 1 is a schematic front view showing a structure of an apparatus for preparing microneedles according to a preferred embodiment of the present invention, fig. 2 is a schematic top view showing an external structure of a vacuum chamber according to a preferred embodiment of the present invention, fig. 3 is a schematic top view showing an internal structure of a vacuum chamber according to a preferred embodiment of the present invention, and fig. 4 is a schematic top view showing a structure of an apparatus for preparing microneedles according to a preferred embodiment of the present invention.

As shown in fig. 1 to 4, the present embodiment provides an apparatus for preparing a microneedle, which can pierce the stratum corneum of a human body to form a channel for facilitating drug delivery, thereby promoting transdermal absorption of a drug. The shape of the microneedle body is not limited in the present application, and includes, but is not limited to, a needle body whose tip portion is a convex structure, and the tip portion may be a convex structure having a sharp shape or a non-sharp convex structure; the needle body includes, but is not limited to, a cone shape, a polygonal pyramid shape, or a fusiform shape. The solution for preparing the microneedles has a certain viscosity, and the solution includes, but is not limited to, a polymer solution, and the kind of the solution is not particularly limited herein.

The equipment for preparing the micro-needle specifically comprises a micro-needle female die 1, a vacuum chamber 2, a filling mechanism 3 and a vacuumizing mechanism 4; a groove (not shown) matched with the microneedle body is formed on the surface of the microneedle female die 1; the filling mechanism 3 is at least partially arranged in the vacuum chamber and is used for releasing the solution for preparing the micro-needle; the vacuum chamber 2 is used for providing a closed environment so as to prepare the micro-needle under the vacuum condition; the vacuum pumping mechanism 4 is connected to the vacuum chamber 2 and is used for pumping vacuum in the vacuum chamber 2.

As shown in fig. 2, the vacuum chamber 2 includes three independent vacuum chambers, namely a feeding chamber 21, a filling chamber 22 and a discharging chamber 23, which are adjacently arranged in sequence. The feeding cavity 21 is used for receiving the microneedle female die 1 in a non-negative pressure state, namely a normal pressure state; herein, it should be understood that the normal pressure is not an absolute standard atmospheric pressure, but the actual atmospheric pressure may not be equal to the standard atmospheric pressure due to different geographic positions, sea wave heights, temperatures, and the like, so that the application has no particular limitation on the pressure value of the normal pressure; the vacuumizing mechanism 4 is used for vacuumizing the feeding cavity 21 after the feeding cavity 21 receives the microneedle female die 1, so that the microneedle female die 1 and the feeding cavity 21 are both in a negative pressure state; the filling cavity 22 is used for receiving the microneedle female die 1 transferred from the feeding cavity 21 in the negative pressure state; the filling mechanism 3 is used for pouring the solution for preparing the microneedles on the surface of the microneedle female die 1 in the filling cavity 22 in the negative pressure state to obtain the microneedle female die 1 after the solution is poured, and further preferably, homogenizing the microneedle female die 1 after the solution is poured so as to uniformly flatten the solution on the surface of the microneedle female die 1; the discharging cavity 23 is used for receiving the microneedle female die 1 of the casting solution transferred from the filling cavity 22 in the negative pressure state, and is used for breaking vacuum after receiving the microneedle female die 1 of the casting solution, so that the discharging cavity 23 is in the non-negative pressure state, and the microneedle female die 1 with the solution is obtained, and at the moment, the microneedle female die 1 with the solution is in the normal pressure state; and (3) further curing and molding the microneedle female die 1 with the solution, and then demolding to obtain the microneedle (integrated microneedle).

The present embodiments also provide a method of preparing a microneedle, the method comprising:

step 11: placing the microneedle female die 1 in a non-negative pressure feeding cavity 21, and then vacuumizing the feeding cavity 21 by using a vacuumizing mechanism 4 so as to enable the feeding cavity 21 and the microneedle female die 1 to be in a negative pressure state;

step 12: transferring the microneedle female die 1 in a negative pressure state from the feeding cavity 21 in the negative pressure state to the filling cavity 22 in the negative pressure state, pouring a solution onto the surface of the microneedle female die 1 in the filling cavity 22 through the filling mechanism 3 in the negative pressure state, and after the solution is poured, preferably homogenizing the microneedle female die 1 in which the solution is poured through the homogenizing mechanism 6 so as to uniformly flatten the solution on the surface of the microneedle female die 1;

step 13: transferring the microneedle female die 1 for casting solution from the filling cavity 22 in a negative pressure state to the discharging cavity 23 in a negative pressure state, and maintaining the negative pressure state of the filling cavity 22; after the microneedle female die 1 for casting the solution is sent out of the filling cavity 22, the filling cavity 22 is closed, so that the filling cavity 22 can still maintain a negative pressure state to prepare for receiving the next microneedle female die 1 for casting the solution;

step 14: after transferring the microneedle female die 1 for casting the solution to the discharge cavity 23 in the negative pressure state, performing vacuum breaking on the discharge cavity 23 in the negative pressure state to enable the discharge cavity 23 to be in the non-negative pressure state, and obtaining the microneedle female die 1 with the solution; it should be understood that the discharging cavity 23 is vacuumized before the microneedle negative mold 1 receiving the casting solution, and when the discharging cavity 23 is vacuumed, the solution fills the groove of the microneedle negative mold 1 by means of self gravity;

step 15: and (3) curing and forming the microneedle female die with the solution, and then demoulding to obtain the microneedle.

After step 14, it is preferable to further include the steps of:

after the discharging cavity 23 is broken to be vacuum, an outlet of the discharging cavity 23 is opened, the microneedle female die 1 loaded with the casting solution is transferred to the outside of the discharging cavity 23, so that the discharging cavity 23 after being broken to be vacuum is in an idle-load state, after the discharging cavity 23 after being broken to be vacuum is idle, the discharging cavity 23 is closed, the discharging cavity 23 starts to be vacuumized until the vacuum degree in the discharging cavity 23 reaches a set value, and then the microneedle female die 1 is stopped to be ready for receiving the next casting solution.

In step 12, after the negative-pressure microneedle negative mold 1 is sent out of the feeding cavity 21, the feeding cavity 21 is closed, and vacuum breaking is started for the feeding cavity 21 until the pressure in the feeding cavity 21 is consistent with the external environment, and then the feeding cavity is stopped to prepare for receiving the next microneedle negative mold 1.

The three independent vacuum cavities are arranged, so that the waiting time during filling operation can be greatly reduced, and the vacuum filling efficiency of microneedle preparation is effectively improved. It should be understood that if a single vacuum chamber is repeatedly vacuumized, vacuumized and vacuumized, the filling time is long, the filling efficiency is low, the energy consumption is high, and the production cost is high. The vacuum chamber of the present invention is composed of three independent vacuum chambers, wherein the filling chamber 22 does not need to repeatedly perform the operations of vacuum pumping, vacuum breaking and vacuum pumping, thereby reducing energy consumption, reducing waiting time during filling, and having high filling efficiency. Therefore, the three independent vacuum chambers can greatly improve the production takt time and increase the equipment capacity, and in doing so, the single machine capacity can be improved to 4 pieces/minute. Especially, before filling, the microneedle female die 1 is vacuumized for a long time, so that the air content in the groove of the microneedle female die 1 is greatly reduced, the quality of the finally formed microneedle is ensured, and the yield of microneedle preparation is improved. And the filling of the solution is carried out under the vacuum condition, so that the air in the groove of the microneedle female die can be sufficiently discharged, the solution is filled in the groove of the microneedle female die after the vacuum of the discharging cavity 23 is broken, and the forming quality of the microneedle is ensured. Particularly, under the vacuum condition, the viscous solution on the surface of the microneedle female die can be effectively flattened by combining the homogenization treatment of the homogenization mechanism 6, so that the solution is uniformly and flatly paved on the surface of the microneedle female die, and the microneedle forming quality is further ensured.

In other embodiments, the solution may be cast in a non-negative pressure state, then homogenized by the homogenizing mechanism 6, and after homogenization, vacuumized, and then broken to fill the solution. Specifically, the present embodiment also provides another method of preparing a microneedle, the method comprising:

step 21: placing the microneedle female die 1 in a filling cavity 22 in a non-negative pressure state, and pouring the solution onto the surface of the microneedle female die 1 through a filling mechanism 3;

step 22: homogenizing the microneedle female die 1 by a homogenizing mechanism 6 so as to uniformly flatten the solution on the surface of the microneedle female die 1;

step 23: vacuumizing the filling cavity 22 through a vacuumizing mechanism 4 so as to enable the filling cavity 22 and the microneedle female die 1 to be in a negative pressure state;

step 24: after the homogenized microneedle female die 1 is transferred to the discharge cavity 23 in a negative pressure state, breaking vacuum in the discharge cavity 23 in the negative pressure state to enable the discharge cavity 23 to be in a non-negative pressure state, and obtaining the microneedle female die 1 with solution;

step 25: and (3) curing and forming the microneedle female die 1 with the solution, and then demoulding.

It is to be understood that the vacuum pressure of each vacuum chamber is set according to the microneedle product to be manufactured. The vacuum pressure of each vacuum cavity needs to meet certain conditions, if the vacuum pressure is insufficient, the microneedle forming quality is influenced, and if the vacuum pressure is too large, the energy consumption is increased, the vacuumizing and vacuum breaking time is prolonged, and the equipment productivity is reduced. In this embodiment, the working pressures of the feeding cavity 21, the filling cavity 22 and the discharging cavity 23 are preferably equal, and the working pressure is preferably-95 Kpa to-80 Kpa, so that under the working pressure, the microneedle forming quality can be ensured, the vacuumizing and vacuum breaking time can be reduced, and the equipment productivity can be improved. Further, the control precision of the working pressure of the feeding cavity 21, the filling cavity 22 and the discharging cavity 23 is +/-1 Kpa. Further preferably, the vacuumizing time of the feeding cavity 21 and the discharging cavity 23 is 10-16 seconds, the vacuum breaking time of the feeding cavity 21 and the discharging cavity 23 is 3-5 seconds, and the filling cavity 22 is always in a negative pressure state during production, so that no special requirement is imposed on the vacuumizing time.

The equipment for preparing the microneedles preferably further comprises a tray 5, wherein the tray 5 is used for loading the microneedle female die 1 to sequentially enter the feeding cavity 21, the filling cavity 22 and the discharging cavity 23, and more preferably, the microneedle female dies 1 with different sizes can be conveyed by the same tray 5.

Further, the preferable use step of the vacuum chamber 5 includes: firstly, conveying a tray 5 loaded with a microneedle female die 1 into a feeding cavity 21 under normal pressure, then closing the feeding cavity 21 to isolate the feeding cavity 21 from other 2 vacuum cavities and an external environment, then vacuumizing the feeding cavity 21 until the vacuum pressure reaches a set value, stopping vacuumizing and maintaining a negative pressure state; then opening the outlet of the feeding cavity 21, transferring the vacuumized microneedle female die 1 together with the tray 5 into the filling cavity 22, and closing the filling cavity 22 to isolate the filling cavity 22 from other 2 vacuum cavities and the external environment, wherein the filling cavity 22 is vacuumized before being filled into the microneedle female die 1; after the micro-needle female die 1 is poured, an outlet of the filling cavity 22 is opened, the micro-needle female die 1 filled with the solution and the tray 5 are conveyed to the discharging cavity 23, the discharging cavity 23 is closed, the discharging cavity 23 is isolated from other 2 vacuum cavities and the external environment, and then the discharging cavity 23 is subjected to vacuum breaking until the pressure in the discharging cavity 23 is consistent with the external environment.

In addition, in step 13, after the microneedle female die 1 finishes pouring the solution, the homogenization treatment is continuously performed in the filling cavity 22, and after the homogenization treatment, the outlet of the filling cavity 22 is opened. That is, the apparatus for preparing microneedles further comprises a homogenizing mechanism 6, and a pouring station and a homogenizing station are preferably disposed in the filling cavity 22; when the filling cavity 22 is in a negative pressure state, transferring the microneedle female die 1 from the tray 5 to the pouring station, and then pouring the solution onto the surface of the microneedle female die 1 in the negative pressure state by using the filling mechanism 3; and after the microneedle female die 1 finishes the solution casting, the microneedle female die 1 is transferred to the homogenizing station through the tray 5, and the homogenizing mechanism 6 is used for homogenizing the microneedle female die 1 after the solution casting so as to uniformly fill the solution on the surface of the microneedle female die 1.

In this embodiment, the homogenizing mechanism 6 mainly drives the tray 5 to move to achieve homogenizing treatment of the microneedle negative mold 1, and the movement of the tray 5 may be at least one of various movements, such as horizontal rotation, horizontal movement, shaking, and up-and-down swinging. In the mode, the homogenizing mechanism 6 is not in contact with the solution for preparing the microneedles, so that the risk of pollution of the solution is reduced, the homogenizing effect is good, and the homogenizing mechanism can be realized through a simpler structure and operation, so that the stability and consistency of the content of the solution filled in each groove are ensured, and the microneedle forming quality is ensured.

In some embodiments, the homogenizing mechanism 6 includes a grabbing mechanism and a driving mechanism, the driving mechanism is used for driving the grabbing mechanism to rotate horizontally around its axis, the grabbing mechanism is used for grabbing the tray 5, and then the driving mechanism drives the tray 5 and the microneedle female die 1 to rotate horizontally together through the grabbing mechanism, so that the solution on the surface of the microneedle female die 1 is spread uniformly by centrifugal force and fills each groove. The homogenizing mechanism 6 and the liquid filling mechanism 3 can be arranged in the same filling cavity 22, or an independent vacuum cavity can be arranged between the filling cavity 22 and the discharging cavity 23 to independently place the homogenizing mechanism 6.

In other embodiments, the homogenizing mechanism 6 includes a grabbing mechanism and a driving mechanism, the driving mechanism is used for driving the grabbing mechanism to swing up and down, the grabbing mechanism is used for grabbing the tray 5, then the driving mechanism drives the tray 5 and the microneedle female die 1 to swing up and down together through the grabbing mechanism, so that the solution on the surface of the microneedle female die 1 is uniformly spread through the up-and-down swing, and all the grooves are filled with the solution. In other embodiments, the gripping mechanism may be eliminated, and the driving mechanism is configured as a motion stage for carrying the tray 5, and the motion stage is used for driving the tray 5 to rotate horizontally or swing up and down or to shake (including vibrate) or move horizontally.

Fig. 5 to 10 show a homogenization mechanism 6 according to a preferred embodiment. The homogenizing mechanism 6 includes a gripping mechanism including a spindle assembly 610 and a clamping assembly 620, and a drive mechanism including a servo motor 630 and a transmission assembly 640. The spindle assembly 610 includes a spindle 611 and a base 612, and a bottom end of the spindle 611 is fixedly connected or detachably connected to the base 612. The clamping assembly 620 includes at least three jaws 621, the at least three jaws 621 being evenly distributed on the base 612 about the axis of the main shaft 611. At least three claws 621 cooperate with each other to clamp and fix the tray 5. Preferably, the number of the claws 621 is four, so that the clamping effect is stable. Each jaw 621 is movable relative to the base 612 to grip or release the tray 5. The servo motor 630 is connected with the main shaft 611 through a transmission assembly 640, so as to drive the main shaft 611 to horizontally rotate around the axis of the main shaft 611 through the transmission assembly 640. The transmission assembly 640 is preferably a belt pulley assembly, and specifically, the transmission assembly 640 includes a driving pulley 641, a belt 642 and a driven pulley 643, the driving pulley 641 is connected to a motor shaft (not labeled) of the servo motor 630, the belt 642 is sleeved on the driving pulley 641 and the driven pulley 643, and the driven pulley 643 is sleeved on a top end of the main shaft 611. Preferably, the servo motor 630 is disposed in parallel with the main shaft 611. The servo motor 630 drives the main shaft 611 and the base 612 to rotate through the belt pulley assembly, so that the tray 5 and the female microneedle mould 1 are driven to rotate together, and the solution is uniformly coated on the surface of the female microneedle mould 1. The main shaft 611 may be secured to a bearing block 615 by a bearing 613 and a nut 614. The bearing block 615 and the servo motor 630 are fixed to the base 650. The base 612 may be of various shapes, preferably circular. It should be understood that the axis of rotation of main shaft 611 is parallel with the depth direction of the recess of micropin bed die, the axis of rotation of main shaft 611 is parallel with the axial direction of recess promptly, thereby rely on the rotatory stickness solution (the solution of preparing the micropin) of flattening the micropin bed die of main shaft 611, then stickness solution relies on gravity to get into the recess of micropin bed die, this mode can effectually flatten the stickness solution on the bed die surface of micropin, the homogenization is effectual, and direct contact solution has not been avoided, the pollution to solution, further guarantee micropin shaping quality.

Further preferably, the driving mechanism further comprises a cylinder assembly 660, an elastic member 670 and a turntable 680. The turntable 680 is sleeved on the main shaft 611 and can rotate relative to the main shaft 611. One end of the elastic member 670 is connected to the main shaft 611, and the other end is connected to the turntable 680. When the rotating disc 680 is driven by the cylinder assembly 660 to rotate towards the first direction, the elastic part 670 stores elastic potential energy and the claws 621 of the clamping assembly 620 move to the release position, so that the clamping of the tray 5 is released or the clamping of the tray 5 is facilitated after the clamping is released; and when the rotating disc 680 is released from the acting force of the cylinder assembly 660, the elastic member 670 releases elastic potential energy and drives the rotating disc 680 to rotate in the second direction, so that the jaws 621 of the clamping assembly 620 move to the locking position, so as to clamp the tray 5 or release the tray 5 to return to the original position. The mode of controlling the loosening and clamping of the clamping jaw 621 by using the air cylinder and the energy storage element does not need to be provided with complex auxiliary equipment such as an air path, a circuit and the like, so that the structure is simple, the reliability is good, the rotating speed of the main shaft 611 can be controlled by the servo motor 630, and a better centrifugal effect is achieved. The elastic member 670 is generally a tension spring 671, one end of the tension spring 671 is fixed on the main shaft 611, and the other end is fixed on the turntable 680. In this embodiment, one end of the tension spring 671 is fixed to the first pin 672, the first pin 672 is fixed to the main shaft 611, the other end of the tension spring 671 is fixed to the second pin 673, and the second pin 673 is fixed to the turntable 680. The first direction is opposite to the second direction.

In order to avoid the up-and-down bouncing of the turntable 680, the homogenization mechanism 6 further comprises an auxiliary part 690, and the auxiliary part 690 can be used for limiting the axial position of the turntable 680. Optionally, the auxiliary member 690 includes pressing pieces 691, the pressing pieces 691 are fixed on the base 612 and are used for pressing against the turntable 680 in the axial direction, and the number of the pressing pieces 691 is at least three and is uniformly arranged on the base 612 in the circumferential direction.

The clamping assembly 620 may include a guide 622, a slider 623, a holder 624, and a restraint pin 625. The guide rail 622 is arranged along the radial direction of the base 612, the slider 623 is slidably disposed on the guide rail 622, the fixing seats 624 are fixed on the slider 623, and each of the claws 621 is fixed on a corresponding one of the fixing seats 624. The spacing pin 625 is fixed on the fixing base 624, the turntable 680 is provided with an arc-shaped spacing groove 681, the spacing pin 625 is movably arranged in the arc-shaped spacing groove 681, and the two ends of the arc-shaped spacing groove 681 are different from the center of the turntable 680. Before clamping, the clamping assembly 620 is in an initial position, at which time the stopper pin 625 abuts against the curved proximal end of the stopper groove 681, and the curved proximal end of the stopper groove 681 is closer to the turntable center than the curved distal end. When the turntable 680 rotates in a first direction, the limit pin 625 moves from the proximal end of the arc-shaped limit groove 681 to the distal end, and drives the claw 621 to move outward until the limit pin 625 abuts against the distal end of the limit groove 681; when the rotating disc 680 rotates in the second direction, the limit pin 625 moves from the proximal end of the arc-shaped limit groove 681 to the distal end, and drives the claw 621 to move inward until the limit pin 625 abuts against the proximal end of the limit groove 681.

Referring to fig. 7 to 8, the cylinder assembly 660 includes a push rod 661, and a fixed post 682 is disposed on the rotating plate 680. As shown in fig. 9, when the claw 621 needs to be released, the air cylinder drives the push rod 661 to extend and abut against the fixed column 682, so as to push the fixed column 682 to rotate the rotating disc 680 in the first direction, and the fixed seat 624 is driven to slide radially outwards along the guide pipe 622 through the limit pin 625, so that the claw 621 releases the tray 5; as shown in fig. 10, after the push rod 661 is removed, the rotating disc 680 is pulled to rotate in the second direction by the elastic force of the tension spring 671, and the fixing seat 624 is driven to slide radially inwards along the guide tube 622 by the limiting pin 625, so as to clamp the tray 5 by the claws 621.

In order to further improve the homogenization effect, the homogenization mechanism 6 of the present embodiment is configured to have different working stages, which are an acceleration stage, a uniform speed stage and a deceleration stage, respectively, and the homogenization mechanism 6 performs acceleration rotation, uniform speed rotation and deceleration rotation in sequence when performing homogenization treatment on the microneedle negative mold 1, so that the solution is uniformly filled on the surface of the microneedle negative mold. Fig. 11 shows a speed-time curve of the homogenizing mechanism 6, with time (in seconds) on the abscissa and speed (in revolutions/minute) on the ordinate. In practical use, the main shaft 611 rotates at an accelerated speed, when the main shaft 611 rotates at a predetermined speed, the main shaft 611 rotates at a constant speed, and after the main shaft 611 rotates at the constant speed for a certain time, the main shaft 611 rotates at a decelerated speed until the homogenization operation is completed. Since the rotation speed and the homogenization time of the main shaft 611 are different according to the viscosity of the solution when the microneedle product is homogenized, the speed and the time of each stage can be set according to the material and the viscosity of the microneedle, which is not limited herein. Further optionally, the rotating speed in the uniform speed stage is 300-1000 rpm, the time in the acceleration stage can be within 2 seconds, the time in the uniform speed stage can be 2-18 seconds, and the time in the deceleration stage can be 18-32 seconds.

Further, the apparatus for preparing microneedles further includes a transfer line for automatically transferring the trays 5 and enabling reuse of the trays 5. The equipment for preparing the microneedles is provided with a feeding area and a discharging area, wherein the feeding area is arranged on one side of the feeding cavity 21, and the discharging area is arranged on one side of the discharging cavity 23. The conveyor line may repeatedly convey the trays 5 of the blanking zone to the feeding zone so as to reuse the trays 5.

As shown in fig. 1, the transfer lines include a feeding line 7, a discharging line 8, and a transfer line 9. A feed conveyor line 7 is provided at the feed zone, i.e. at the inlet of the vacuum chamber 5. A blanking conveyor line 8 is provided at the blanking zone, i.e. at the outlet of the vacuum chamber 5. That is, the vacuum chamber 2 is provided between the feeding line 7 and the discharging line 8.

The transfer conveying line 9 can be directly connected with the feeding conveying line 7 and the blanking conveying line 8 to form a complete continuous circulating conveying line. Transport transfer chain 9 and material loading transfer chain 7 and unloading transfer chain 8 and do not connect and form a discontinuous circulating transfer chain, and at this moment, the automatic transport mechanism of accessible conveys the tray 5 on the unloading transfer chain 8 to transporting transfer chain 9, and the automatic transport mechanism will transport tray 5 on the transfer chain 9 and convey to material loading transfer chain 7 again. Therefore, a production cycle is formed, the automation degree of microneedle preparation is high, the production takt can be greatly improved, and the equipment productivity is increased.

Further, the tray 5 loaded with the microneedle female die 1 in the normal pressure state is conveyed to the feeding cavity 21 through the feeding conveying line 7, and the tray 5 from the discharging cavity 23 is received by the discharging conveying line 8; empty pallets 5 are received from the blanking line 8 via the transfer line 9 and empty pallets 5 are transferred to the loading zone by the transfer line 9. The position of the transfer conveyor line 9 relative to the feeding conveyor line 7 and the discharging conveyor line 8 is not limited. Fig. 1 shows that the transfer conveyor line 9 is arranged below the feeding conveyor line 7 and the discharging conveyor line 8, which saves space. In a matching manner, the apparatus for preparing microneedles further comprises a holder 16 for setting the vacuum chamber 2 and the transfer line.

The apparatus for preparing microneedles preferably further comprises an automatic transfer mechanism, by which empty trays 5 on the blanking transfer line 8 are transferred to the transfer line 9, and the empty trays 5 on the transfer line 9 are transferred to the loading transfer line 7 by the automatic transfer mechanism. The automatic transfer mechanism is preferably a lifting device, the lifting device comprises a feeding lifter 10 and a discharging lifter 11, the feeding lifter 10 is arranged in a feeding area, and the discharging lifter 11 is arranged in a discharging area. At this time, the transfer line 9 is disposed at a different level from the feeding line 7 and the discharging line 8, and for example, fig. 1 shows that the transfer line 9 is disposed below, as just below, the feeding line 7 and the discharging line 8. Transfer chain 9 and material loading transfer chain 7 are transported in the butt joint of material loading lift 10, and transfer chain 9 and unloading transfer chain 8 are transported in the butt joint of unloading lift 11, and material loading lift 10 conveys to material loading transfer chain 7 with transporting unloaded tray 5 on the transfer chain 9 through automatic rising, and unloading lift 11 conveys to transporting transfer chain 9 with unloaded tray 5 on the unloading transfer chain 8 through automatic rising. Of course, the automatic transfer mechanism is not limited to the lifting device, and may be a robot arm, an automated transport vehicle, an automated track, or the like.

Further, an operation step of preparing the microneedle using the apparatus for preparing the microneedle described above includes:

firstly, in a feeding area, placing a microneedle female die 1 on a no-load tray 5 of a feeding conveying line 7 in a manual or mechanical and automatic mode, and conveying the microneedle female die 1 loaded on the tray 5 into a feeding cavity 21 of a vacuum cavity 2 through the feeding conveying line 7; after the microneedle female die 1 finishes the solution casting and homogenization treatment, the microneedle female die is conveyed to the discharging cavity 23 through the tray 5 to break vacuum; after vacuum breaking, the microneedle female die 1 filled with the solution is loaded through the tray 5 and enters the blanking conveying line 8; in the blanking area, taking out the microneedle female die 1 filled with the solution from the tray 5 in a manual or mechanical automatic mode; in the process, the microneedle negative mould 1 is taken out from the tray 5 and then is usually placed on a transfer tray 12, and then the microneedle negative mould 1 filled with the solution is conveyed to the next process (such as a drying process and a drying process) by the transfer tray 12; after the microneedle female die 1 filled with the solution is taken out of the tray 5, the empty tray 5 is conveyed to the transfer conveying line 9 through the blanking lifter 11, the empty tray 5 is conveyed to the loading area through the transfer conveying line 9, and after the empty tray reaches the loading area, the empty tray 5 is conveyed to the loading conveying line 7 through the loading lifter 10, so that the empty tray 5 receives the next die again.

With continued reference to fig. 2, the feed chamber 21 is provided with a first vacuum-pumping valve 211. The first vacuum-pumping valve 211 is communicated with the feeding cavity 21, the first vacuum-pumping valve 211 is connected with the vacuum-pumping mechanism 4, and the vacuum-pumping mechanism 4 pumps vacuum to the feeding cavity 21 through the first vacuum-pumping valve 211 so as to maintain the feeding cavity 21 in a negative pressure state. Further, the apparatus for preparing microneedles further comprises a sensor assembly, the sensor assembly comprises a first sensor 212, the feeding cavity 21 is provided with the first sensor 212, the first sensor 212 is used for detecting the vacuum degree in the feeding cavity 21 in real time, the first sensor 212 is preferably in communication connection with a controller, the first sensor 212 preferably feeds back the vacuum degree to the controller, and the controller controls the pressure in the feeding cavity 21 according to the fed-back vacuum degree. The feeding cavity 21 is provided with a first vacuum breaking valve 213, and the first vacuum breaking valve 213 is used for communicating with the external environment to realize vacuum breaking of the feeding cavity 21. Preferably, the first vacuum breaking valve 213 is connected to a controller in communication, and the controller controls the opening and closing of the first vacuum breaking valve 213. Preferably, the first evacuation valve 211 is communicatively connected to a controller, and the controller controls the opening and closing of the first evacuation valve 211.

Fig. 2 also shows an exemplary embodiment of the filling chamber 22. The filling chamber 22 is provided with a second evacuation valve 221. The second vacuum-pumping valve 221 is communicated with the filling cavity 22, the second vacuum-pumping valve 221 is connected with the vacuum-pumping mechanism 4, and the vacuum-pumping mechanism 4 performs vacuum pumping on the filling cavity 22 through the second vacuum-pumping valve 221 so as to maintain the filling cavity 22 in a negative pressure state. Preferably, the sensor assembly further includes a second sensor 222, the second sensor 222 is disposed on the filling cavity 22, the second sensor 222 is used for detecting the vacuum degree in the filling cavity 22 in real time, the second sensor 222 is preferably in communication connection with the controller, the second sensor 222 preferably feeds the vacuum degree back to the controller, and the controller controls the pressure in the filling cavity 22 according to the fed vacuum degree. The filling cavity 22 is provided with a second vacuum breaking valve 223, and the second vacuum breaking valve 223 is used for being communicated with the external environment so as to realize vacuum breaking of the filling cavity 22. Preferably, the second vacuum breaking valve 223 is in communication with a controller, and the controller controls the opening and closing of the second vacuum breaking valve 223. Preferably, the second evacuation valve 221 is communicatively connected to a controller, and the controller controls the opening and closing of the second evacuation valve 221.

Fig. 2 also shows an exemplary embodiment of the outlet chamber 23. A third vacuum-pumping valve 231 is arranged on the discharging cavity 23. The third vacuum-pumping valve 231 is communicated with the discharging cavity 23, the third vacuum-pumping valve 231 is connected with the vacuum-pumping mechanism 4, and the vacuum-pumping mechanism 4 performs vacuum-pumping on the discharging cavity 23 through the third vacuum-pumping valve 231 so as to maintain the discharging cavity 232 in a negative pressure state. Preferably, the sensor assembly further includes a third sensor 232, the discharging cavity 23 is provided with the third sensor 232, the third sensor 232 is used for detecting the vacuum degree in the discharging cavity 23 in real time, the third sensor 232 is preferably in communication connection with the controller, the third sensor 232 preferably feeds the vacuum degree back to the controller, and the controller controls the pressure in the discharging cavity 23 according to the fed vacuum degree. The discharging cavity 23 is provided with a third vacuum breaking valve 233, and the third vacuum breaking valve 233 is used for communicating with the external environment to realize vacuum breaking of the discharging cavity 23. Preferably, the third vacuum breaking valve 233 is in communication connection with a controller, and the controller controls the opening and closing of the third vacuum breaking valve 233. Preferably, the third vacuum-pumping valve 231 is connected to the controller in communication, and the controller controls the opening and closing of the third vacuum-pumping valve 231.

Fig. 3 shows the internal structure of the vacuum chamber 2 of an exemplary embodiment. The inlet of the feeding cavity 21 is provided with a first gate 241, preferably the outlet of the feeding cavity 21 and the inlet of the filling cavity 22 share a second gate 243, and preferably the outlet of the filling cavity 22 and the inlet of the discharging cavity 23 share a third gate 247, and the outlet of the discharging cavity 23 is provided with a fourth gate 249. The first gate 241 is used for controlling the opening and closing of the inlet of the feeding cavity 21, the second gate 243 is used for controlling the opening and closing of the feeding cavity 21 and the filling cavity 22, the third gate 247 is used for controlling the opening and closing of the filling cavity 22 and the discharging cavity 23, and the fourth gate 249 is used for controlling the opening and closing of the outlet of the discharging cavity 23.

The application steps of the gate can be as follows: when the feeding cavity 21 is in a normal pressure state, the first gate 241 is opened, the tray 5 provided with the microneedle female die 1 is conveyed to the first conveying line 242 of the feeding cavity 21, then the first gate 241 is closed, and the feeding cavity 21 starts to be vacuumized; after the evacuation is completed, the second shutter 243 is opened, and the trays 5 enter the filling chamber 22 through the first transfer line 242 and the second transfer line 244, wherein the second transfer line 244 is disposed inside the filling chamber 22; after the tray 5 reaches the station of the liquid filling mechanism 3, the second gate 243 is closed, the feeding cavity 21 can be subjected to vacuum breaking after the second gate 243 is closed, and after the feeding cavity 21 is subjected to vacuum breaking, the first gate 241 is opened to wait for the next tray 5 to enter; after the tray 5 reaches the station of the liquid filling mechanism 3, the liquid filling mechanism 3 starts to inject a set amount of solution onto the surface of the microneedle female die 1, and after the liquid filling is finished, the tray 5 is conveyed to the station of the homogenizing mechanism 6 by the second conveying line 244; after the tray 5 reaches the homogenization station, the homogenization mechanism 6 carries out homogenization treatment on the microneedle female die 1, so that the solution can quickly, uniformly and completely cover the surface of the microneedle female die 1; after homogenization, the third shutter 247 is opened and the trays 5 are conveyed into the discharge chamber 23 via the second conveyor line 244 and the third conveyor line 248, the third conveyor line 248 being arranged in the discharge chamber 22; after the tray 5 is in place, the third gate 247 is closed, and then the discharging cavity 23 starts to break vacuum until the internal air pressure of the discharging cavity 23 is consistent with the outside; then, the fourth shutter 249 is opened, the tray 5 is sent out of the discharging conveyor line 8 through the third conveyor line 248, then the fourth shutter 249 is closed, and then the discharging chamber 23 starts to be evacuated until the degree of vacuum inside the discharging chamber 23 reaches a set value, and then is stopped.

Preferably, the apparatus for preparing microneedles further comprises a controller, preferably in communication with the vacuum-pumping valve, the vacuum-breaking valve, the vacuum-pumping mechanism 4 and the sensor assembly, for controlling automated operation of these apparatuses. The vacuum pumping mechanism 4 preferably comprises a first vacuum pumping pump, a second vacuum pumping pump and a third vacuum pumping pump, wherein the first vacuum pumping pump is used for vacuumizing the feeding cavity 21 through a first vacuum pumping valve 211; the second vacuum pump is used for vacuumizing the filling cavity 22 through a second vacuum valve 221; the third vacuum pump is used for vacuumizing the discharging cavity 23 through a third vacuum valve 231. The controller is used for controlling the first vacuum breaking valve 213 to open to break vacuum in the feeding cavity 21, controlling the second vacuum breaking valve 223 to open to break vacuum in the pouring cavity 22, and controlling the third vacuum breaking valve 233 to open to break vacuum in the discharging cavity 23. Preferably, the controller is configured to control the vacuum degree of the corresponding chamber according to the information detected by the first sensor 212, the second sensor 222, and the third sensor 232, that is, control the corresponding vacuum pump to pump vacuum according to the information detected by the sensors and control the vacuum degree within a desired vacuum degree. Further, when the microneedle negative die 1 in the fourth state is transferred to the outside from the vacuum-broken discharging cavity 23, the controller controls the third vacuum-pumping pump to vacuum the discharging cavity 23. Further, after the microneedle negative mold 1 in the negative pressure state is transferred to the filling cavity 22 in the negative pressure state, the controller controls the first vacuum breaking valve 213 to open so as to break vacuum in the feeding cavity 21.

As shown in fig. 4, in order to further improve the degree of automation, it is preferable that the apparatus for preparing microneedles further includes an automatic feeding mechanism 13 and an automatic feeding mechanism 14, both of which are disposed at the feeding zone. The automatic feeding of the microneedle female die 1 is completed by the automatic feeding mechanism 13 and the automatic feeding mechanism 14 instead of manual operation.

The automatic feeding mechanism 13 is used for automatically transporting the microneedle female die 1 under normal pressure to a feeding station. The automatic feeding mechanism 14 is used for automatically taking the microneedle female die 1 under the normal pressure from the feeding station and placing the microneedle female die on the tray 5 of the feeding conveying line 7. The structure of the automatic feeding mechanism 13 is not limited in the present application, and for example, the automatic feeding mechanism may be an automatic lifting platform, and the platform may be designed into multiple layers, and each layer may be used for placing one or more microneedle female molds 1 to be filled. The automatic feeding mechanism 14 is preferably a feeding manipulator, which is flexible in movement and convenient to operate and occupies no space.

With continued reference to fig. 5, the apparatus for preparing microneedles preferably further includes an automatic blanking mechanism 15 and a transfer tray 12, which are disposed in the blanking area, wherein the automatic blanking mechanism 15 is configured to take the microneedle negative mold 1 in the fourth state from the tray 5 on the blanking conveying line 8 and place the microneedle negative mold on the transfer tray 12. Therefore, the automatic blanking mechanism 15 replaces manual work to complete the blanking operation of the microneedle female die 1, and further automation of microneedle preparation is realized. Automatic unloading mechanism 15 takes off filled microneedle bed die 1 from tray 5 and places the transportation district at the unloading district automatically, if set up transportation tray 12 in the transportation district, automatic unloading mechanism 15 places the filled microneedle bed die 1 who takes off on transportation tray 12, takes away microneedle bed die 1 from transportation tray 12 by the manual work regularly again. Therefore, an operator can manage a plurality of devices simultaneously, the labor input is greatly reduced, and the labor cost is reduced. The automatic blanking mechanism 12 is typically a blanking robot.

The present application does not specifically limit the structure of the liquid filling mechanism 3. The liquid filling mechanism 3 may include a liquid outlet head for releasing a solution for preparing the microneedles. Preferably go out the liquid head and be a plurality of, a plurality of liquid heads set up side by side, and every is gone out the liquid head and is used for releasing solution, and a plurality of liquid heads release solution simultaneously, and solution pouring is efficient, and solution pouring is effectual.

The type of the Controller is not particularly limited in this embodiment, and the Controller may be hardware for executing Logic operations, such as a single chip, a microprocessor, a Programmable Logic Controller (PLC) or a Field-Programmable Gate Array (FPGA), or a software program, a function module, a function, an Object library (Object Libraries) or a Dynamic Link library (Dynamic-Link Libraries) for implementing the above functions on a hardware basis. Alternatively, a combination of the above two. Those skilled in the art will know how to implement communication between the controller and other devices based on the disclosure of this application. In addition, the controller is a preferable mode of the embodiment, and those skilled in the art may adopt other technical means, such as manual control and mechanical control, to achieve the same technical effect.

The above description is only for the purpose of describing the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention, and any variations and modifications made by those skilled in the art based on the above disclosure are within the scope of the present invention.

Claims

1. The equipment for preparing the microneedle is characterized by comprising a microneedle female die, a vacuum chamber, a filling mechanism and a vacuumizing mechanism; a groove matched with the microneedle body is formed on the surface of the microneedle female die; the filling mechanism is at least partially arranged in the vacuum chamber and is used for releasing the solution for preparing the micro-needle; the vacuumizing mechanism is connected with the vacuum chamber and is used for vacuumizing the vacuum chamber; the vacuum chamber comprises a feeding cavity, a filling cavity and a discharging cavity which are mutually independent;

2. A microneedle device according to claim 1, further comprising a controller and a vacuum breaking valve communicatively connected, said vacuum breaking valve comprising a first vacuum breaking valve and a third vacuum breaking valve; the first vacuum breaking valve is arranged on the feeding cavity, and the third vacuum breaking valve is arranged on the discharging cavity;

the controller is used for controlling the first vacuum breaking valve to be opened so as to break vacuum in the feeding cavity, and is also used for controlling the third vacuum breaking valve to be opened so as to break vacuum in the discharging cavity.

3. A microneedle device according to claim 2, wherein said controller is further in communication with said evacuation mechanism; the controller is used for controlling the vacuumizing mechanism to vacuumize the discharging cavity, the filling cavity and the feeding cavity.

4. An apparatus for microneedle preparation according to claim 3, further comprising a sensor assembly communicatively connected to said controller, said sensor assembly comprising a first sensor, a second sensor and a third sensor;

5. An apparatus for preparing microneedles in claim 1, wherein the apparatus further comprises a homogenizing mechanism, and a pouring station and a homogenizing station are arranged in the filling cavity;

when the filling cavity is in a negative pressure state, the microneedle female die in the filling cavity is arranged at the pouring station, and the filling mechanism is used for pouring the solution to the surface of the microneedle female die;

6. The apparatus for preparing microneedles in claim 5, wherein the homogenizing mechanism comprises a grabbing mechanism and a driving mechanism, the grabbing mechanism comprises a main shaft assembly and a clamping assembly, the driving mechanism comprises a servo motor and a transmission assembly, the main shaft assembly comprises a main shaft and a base, the bottom end of the main shaft is fixedly connected with the base, the clamping assembly comprises at least three clamping jaws, the at least three clamping jaws are uniformly distributed on the base around the axis of the main shaft and are used for clamping and fixing a tray, the tray is loaded with the microneedle female die, the servo motor is used for driving the main shaft to rotate through the transmission assembly, and the axis of the main shaft is parallel to the axis of the groove.

7. An apparatus for preparing microneedles in claim 6, wherein the driving mechanism further comprises a cylinder assembly, an elastic member and a turntable; the turntable is sleeved on the main shaft and can rotate relative to the main shaft, one end of the elastic component is connected with the main shaft, and the other end of the elastic component is connected with the turntable;

8. An apparatus for preparing microneedles in claim 7, wherein the homogenizing mechanism further comprises a pressing block fixed on the base and configured to press against the turntable in an axial direction; the number of the pressing blocks is at least three.

9. The apparatus for preparing microneedles in claim 7, wherein the clamping assembly further comprises a guide rail, a sliding block, fixing seats and a limiting pin, the guide rail is arranged along a radial direction of the base, the sliding block is slidably disposed on the guide rail, the fixing seats are fixed on the sliding block, each of the clamping jaws is fixed on a corresponding one of the fixing seats, the limiting pin is fixed on the fixing seat, the turntable is provided with an arc-shaped limiting groove, the limiting pin is movably disposed in the limiting groove, and two arc-shaped ends of the limiting groove are different from the center of the turntable;

10. The apparatus for preparing microneedles in claim 9, wherein the cylinder assembly comprises a push rod, and the turntable is provided with a fixing column, and the push rod is used for pushing the fixing column to drive the turntable to rotate towards a first direction.

11. An apparatus for preparing microneedles in claim 5, further comprising a tray for loading the microneedle negative molds and a transfer line for transferring the tray; the homogenizing mechanism is used for driving the tray to move so as to carry out homogenizing treatment on the microneedle female die, and the movement of the tray comprises at least one of horizontal rotation, horizontal movement, shaking and up-and-down swinging.

12. An apparatus for preparing microneedles in claim 1, wherein the apparatus further comprises a tray for loading the negative microneedle molds, and the same tray can be loaded with negative microneedle molds of different sizes.

13. The apparatus for preparing microneedles in claim 12, further comprising a loading conveyor line, a discharging conveyor line, and a transferring conveyor line, wherein the loading conveyor line is disposed in the loading area, and the discharging conveyor line is disposed in the discharging area;

14. An apparatus for preparing microneedles in claim 13, wherein the transfer conveyor line is disposed below the loading and unloading conveyor lines, the apparatus further comprising an automatic transfer mechanism for transferring the empty trays on the unloading conveyor line to the transfer conveyor line and for transferring the empty trays on the transfer conveyor line to the loading conveyor line.

15. An apparatus for preparing microneedles in claim 13, further comprising an automatic feeding mechanism and an automatic feeding mechanism arranged in the feeding zone, wherein the automatic feeding mechanism is used for conveying the microneedle negative mould to a feeding station;

16. The apparatus for preparing microneedles in claim 13, further comprising an automatic blanking mechanism and a transfer tray, wherein the automatic blanking mechanism is arranged in the blanking area and used for taking the microneedle female die from the tray on the blanking conveying line and placing the microneedle female die on the transfer tray.

17. The apparatus for preparing microneedles in claim 1, wherein the feeding chamber, the filling chamber and the discharging chamber are arranged adjacent to each other in sequence, a first gate is arranged at an inlet of the feeding chamber, an outlet of the feeding chamber and an inlet of the filling chamber share a second gate, an outlet of the filling chamber and an inlet of the discharging chamber share a third gate, and an outlet of the discharging chamber is provided with a fourth gate.

18. The apparatus for preparing microneedles of claim 17, further comprising a first transfer line disposed within the feed chamber, a second transfer line disposed within the fill chamber, and a third transfer line disposed within the discharge chamber.

19. An apparatus for preparing microneedles in claim 1, wherein the filling mechanism is used to pour the solution to the microneedle negative mold in the filling cavity under negative pressure.