WO2024160192A1

WO2024160192A1 - Microneedle device

Info

Publication number: WO2024160192A1
Application number: PCT/CN2024/074632
Authority: WO
Inventors: 周翔君; 宋雨泽; 房劬; 王思勤; 金磊
Original assignee: 重庆金赛星医疗科技有限公司
Priority date: 2023-01-31
Filing date: 2024-01-30
Publication date: 2024-08-08
Also published as: CN118203751A

Abstract

A microneedle device, comprising: a fluid control module comprising a driving medium storage chamber (1) and a drug flow channel (3), the driving medium storage chamber (1) and the drug flow channel (3) being connected in sequence, and the drug flow channel (3) being provided with first vent channels (4); and a microneedle module comprising a microneedle (5), an inlet end of the microneedle (5) being communicated with an outlet end of the drug flow channel (3). During use, outlets of the first vent channels (4) are opened and a driving medium in the driving medium storage chamber (1) is released, the driving medium pre-stored in the driving medium storage chamber (1) is used for driving a drug pre-stored in the drug flow channel (3), and the drug reaches the interior of the microneedle (5) through the drug flow channel (3) under the action of the driving pressure of the driving medium, thereby achieving drug injection for a user.

Description

Microneedle device

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to Chinese patent application No. 202310048168.9, filed on January 31, 2023, and entitled “Microneedle Device,” which is incorporated herein by reference in its entirety.

Technical Field

The present application relates to the field of medical device technology, and in particular to a microneedle device.

Background Art

At present, injection is one of the main routes of drug administration. However, for drugs that require patients to inject themselves at home, injection faces a series of problems such as the need for professional training, patient fear, safety, cross-infection, etc. Therefore, the optimization of injection routes is a research field that has received widespread attention. Microneedles are a transdermal mechanical device that can penetrate the stratum corneum to form a drug delivery channel without stimulating the subcutaneous pain nerves. Compared with conventional syringe subcutaneous injection, the efficacy of microneedle injection is equal or sometimes even higher. At the same time, it can overcome most of the problems faced by injection, patients have higher compliance, less fear of injections, and relatively higher safety.

In the prior art, some microneedle devices require external energy or substances to start the device and the injection process, which is inconvenient to use and difficult to use anytime and anywhere; some microneedle devices rely on the patient's personal operating ability or accuracy to start the infusion. For example, manual squeezing is used to start the device, which will be affected by the pressing force and angle, which will lead to poor patient compliance and difficulty in continuous use; some microneedle devices use precise mechanical components and electronic components to control the infusion, which have complex structures, high costs, and are difficult to promote; at the same time, the drug injection volume of most existing microneedle drug delivery devices is fixed and cannot be selected, making it difficult to accurately adapt to different populations. That is, the existing microneedle devices have great limitations.

Therefore, there is an urgent need for a microneedle device that can solve the above problems.

Summary of the invention

The present application provides a microneedle device, which has a simple structure and is easy to operate.

The present application provides a microneedle device, comprising:

A fluid control module, the fluid control module comprising a driving medium storage chamber and a drug flow channel, the driving medium storage chamber and the drug flow channel are connected in sequence, and a first exhaust channel is provided on the drug flow channel;

A microneedle module comprises a microneedle, wherein the inlet end of the microneedle is connected to the outlet end of the drug flow channel.

According to the microneedle device provided in the present application, at least one first exhaust channel is provided on the drug flow channel. When a plurality of first exhaust channels are provided on the drug flow channel, the first exhaust channels are spaced apart along the axial direction of the drug flow channel.

According to the microneedle device provided in the present application, when a first exhaust channel is provided on the drug flow channel, a second exhaust channel is provided between the first exhaust channel and the outlet of the drug flow channel;

When a plurality of the first exhaust channels are provided on the drug flow channel, a second exhaust channel is provided between the last of the first exhaust channels and the outlet of the drug flow channel along the direction from the inlet to the outlet of the drug flow channel.

According to the microneedle device provided in the present application, the inner diameters of the first exhaust channel and the second exhaust channel decrease continuously from the inlet to the outlet.

According to the microneedle device provided in the present application, a diameter-changing cut-off point is provided on the first exhaust channel, and the inner diameter from the diameter-changing cut-off point to the outlet end of the first exhaust channel remains unchanged;

The second exhaust passage is provided with a diameter-changing cut-off point, and the inner diameter from the diameter-changing cut-off point to the outlet end of the second exhaust passage remains unchanged.

According to the microneedle device provided in the present application, the first exhaust channel and the second exhaust channel are integrated with the drug flow channel.

According to the microneedle device provided in the present application, the fluid control module also includes a first film layer and a second film layer, the outlet of the first exhaust channel is provided with the first film layer and the second film layer, the second film layer is located on the upper layer of the first film layer, the outlet of the second exhaust channel is provided with the first film layer, the first film layer is used to drive the medium to pass through and prevent the drug from flowing out, and the second film layer is used to seal the outlet of the first exhaust channel.

According to the microneedle device provided by the present application, all of the first film layers are located on the same film layer.

According to the microneedle device provided in the present application, the first film layer is a hydrophobic breathable film, and the second film layer is a sealing film.

According to the microneedle device provided by the present application, the average pore size of the hydrophobic breathable membrane is 0.1 to 100 microns.

According to the microneedle device provided in the present application, the fluid control module further includes a barrier fluid storage portion, and the driving medium storage chamber, the barrier fluid storage portion and the drug flow channel are connected in sequence.

According to the microneedle device provided in the present application, the barrier fluid storage portion and the drug flow channel are integrated.

According to the microneedle device provided in the present application, the microneedle module includes a plurality of microneedles;

It also includes a transfer chamber, which has an inner cavity for accommodating drugs, the transfer chamber is connected to the drug flow channel, and the inlet of the microneedle is connected to the inner cavity of the transfer chamber.

According to the microneedle device provided in the present application, the drug flow channel is an annular spiral or S-shaped.

According to the microneedle device provided in the present application, when the drug flow channel is annular and spiral, the height of the drug flow channel in the Z-axis direction gradually decreases from the inlet to the outlet of the drug flow channel.

According to the microneedle device provided by the present application, the microneedle module further includes a sealing mechanism for sealing the outlet of the microneedle.

According to the microneedle device provided in the present application, the sealing mechanism includes a sealing layer, and the sealing layer covers the outlet end of the microneedle.

The microneedle device provided in the present application, through the combined action of the liquid control module and the microneedle module, when in use, opens the outlet of the first exhaust channel and releases the driving medium in the driving medium storage chamber, and applies a driving action to the drug preset in the drug flow channel through the driving medium preset in the driving medium storage chamber. Under the action of the driving pressure of the driving medium, the drug passes through the drug flow channel to reach the microneedle to inject the drug into the user, and the structure is simple and the operation is easy.

Additional aspects and advantages of the present application will be given in part in the description below, and in part will become apparent from the description below, or will be learned through the practice of the present application.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to more clearly illustrate the technical solutions in the present application or the prior art, a brief introduction will be given below to the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

FIG1 is an isometric view of an embodiment of a microneedle device provided by the present application;

FIG2 is a front view of an embodiment of a microneedle device provided by the present application;

FIG3 is a top view of an embodiment of a microneedle device provided by the present application (the first film layer and the second film layer are hidden);

Fig. 4 is a cross-sectional view of A-A in Fig. 2;

FIG5 is a partial enlarged view of B in FIG4;

FIG6 is a front view of another embodiment of a microneedle device;

FIG7 is a schematic diagram of the internal structure of another embodiment of a microneedle device;

8 is a cross-sectional view of another embodiment of a microneedle device.

Reference numerals:
1. Driving medium storage chamber; 2. Microneedle flow channel; 3. Drug flow channel; 4. First exhaust channel;
5. Microneedle; 6. Second exhaust channel; 7. First film layer; 8. Second film layer; 9. Barrier fluid storage portion; 10. Microneedle fixing seat; 11 Transfer chamber; 12. Sealing layer.

DETAILED DESCRIPTION

In order to make the purpose, technical solutions and advantages of this application clearer, the technical solutions in this application will be clearly and completely described below in conjunction with the drawings in this application. Obviously, the described embodiments are part of the embodiments of this application, not all of them. Based on the embodiments in this application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of this application.

The microneedle device of the present application is described below with reference to FIGS. 1 to 8 .

As shown in Figures 1 to 3, the present application provides a microneedle device, comprising:

A fluid control module, the fluid control module comprises a driving medium storage chamber 1 and a drug flow channel 3, the driving medium storage chamber 1 and the drug flow channel 3 are connected in sequence, and a first exhaust channel 4 is provided on the drug flow channel 3;

The microneedle module comprises a microneedle 5 , and an inlet end of the microneedle 5 is connected to an outlet end of the drug flow channel 3 .

The microneedle device provided by the present application, through the combined action of the fluid control module and the microneedle module, when in use, opens the outlet of the first exhaust channel 4 and releases the driving medium in the driving medium storage chamber 1, and applies a driving action to the drug preset in the drug flow channel 3 through the driving medium preset in the driving medium storage chamber 1, and the drug passes through the drug flow channel 3 under the driving pressure of the driving medium. The channel 3 reaches the microneedle 5 to inject the drug to the user, and the structure is simple and the operation is easy.

It should be noted that the driving medium storage chamber 1 can be a cube, a cuboid, a sphere, an ellipsoid, a cylinder, a cone, a tube, a ring or other irregular shapes. The overall size of the device is suitable for manual operation, between 0.1 and 100 cubic centimeters.

The driving medium storage chamber 1 is used to store high-pressure gas or volatile gas, and the high-pressure gas can be a certain gas or a combination of several gases. Among them, the high-pressure gas can be an inert gas selected from helium, neon, argon, krypton, and xenon; the high-pressure gas can be nitrogen, oxygen, carbon dioxide, sulfur hexafluoride, chlorofluorocarbons, fluorocarbons, nitrous oxide, nitrogen dioxide, propane, n-pentane, etc. The volatile liquid can be a certain liquid or a combination of several liquids. The volatile liquid can be acetic acid, ethyl acetate, alcohol, etc. In the driving medium storage chamber 1, the pressure of the high-pressure gas or volatile liquid is greater than or equal to 1 times the atmospheric pressure, and can be any multiple between 1 and 100 times the standard atmospheric pressure. For example: the pressure of the high-pressure gas or volatile liquid can be 1.05 times, 1.1 times, 1.2 times, 1.3 times, ..., 2 times, 2.1 times, 2.2 times, ..., 9.8 times, 9.9 times, 10 times, ..., 99.9 times, 100 times the standard atmospheric pressure.

The drug is in liquid dosage form, which can be an aqueous solution, non-aqueous solution, suspension, emulsion, gel and cream; the drug can be a small molecule drug or a macromolecule drug. Small molecule drugs can be protac (Proteolysis Targeting Chimeras, protein hydrolysis targeting chimeras) drugs. Macromolecule drugs include peptides, proteins, monoclonal antibodies, bispecific antibodies, ADC drugs (Antibody to drug Conjugate, antibody-coupled drugs). The drug can also be an RNA therapeutic drug, such as mRNA (messenger RNA), RNAi (RNA interference drug), siRNA (short interfering RNA), ASO (antistreptolysin), etc., gene therapy drugs, gene editing drugs. The drug can also be traditional Chinese medicine, Chinese patent medicine, etc. The drug can be a combination of the above multiple drugs. The drug can be growth hormone, insulin, epinephrine, low molecular weight heparin, morphine, vaccine, local anesthetic drug, etc. The drug can also include other excipients, such as preservatives, solubilizers/surfactants, buffers, isotonic regulators, suspending agents, dispersants, wetting agents, etc. The drug can also include other active ingredients. The drug is suitable for administration via intradermal, subcutaneous, or intramuscular injection.

The microneedle 5 may be a metal microneedle, an alloy microneedle, a polymer microneedle, a silk protein microneedle, a ceramic microneedle, a silicon microneedle, a graphene microneedle, etc. The microneedle 5 may be a solid microneedle, a hollow microneedle, a soluble microneedle, etc. In this embodiment, the microneedle 5 is a hollow microneedle as an example.

As shown in FIG3 , in the embodiment of the present application, a plurality of first exhaust channels 4 are provided on the drug flow channel 3, and the plurality of first exhaust channels 4 are arranged at intervals along the axial direction of the drug flow channel 3. By arranging a plurality of first exhaust channels 4 at intervals on the drug flow channel 3, since different first exhaust channels 4 are at different distances from the driving medium storage chamber 1, when the outlets of different first exhaust channels 4 are opened, the corresponding positions of the driving medium in the driving medium storage chamber 1 releasing the pressure are different, and the injection amount of the drug can be controlled by controlling the outlets of the first exhaust channels 4 at different positions, so that different patients can choose according to different usage requirements. Of course, in some embodiments, only one first exhaust channel 4 can be provided on the drug flow channel 3.

It should be noted that the number of the first exhaust channels 4 is set according to actual needs, which is related to the different dosage gradients of the drug for different users, and the number can be 1 to 10, or more than 10. When the number of the first exhaust channels 4 is greater than 1, the spacing between the multiple first exhaust channels 4 on the flow channel is set according to a certain rule.

The rule may be set at a certain distance. For example, assuming that the axial distance from the starting point of the drug flow channel 3 to the first first exhaust channel 4 is L, the axial distance of the drug flow channel 3 between each subsequent first exhaust channel 4 may be any value between L and 10L or any value above 10L, or any value below 0.05L or any value between 0.05L and L;

The rule can also be set according to the volume of a certain drug flow channel 3. For example, assuming that the volume in the flow channel from the starting point of the drug flow channel 3 to the first first exhaust channel 4 is V, the volume in the flow channel between each subsequent first exhaust channel 4 can be any value between V and 10V or any value above 10V, or any value below 0.05V or any value between 0.05V and V.

The above settings are to facilitate different first exhaust channels 4 to correspond to different drug injection volumes, so as to meet the injection needs of different groups of people for drug volumes, especially to meet the different injection needs of people of different weights or different ages for drug volumes. For example, according to the usage of a specific drug in people of different weights, several injection gears of different volumes of drugs are set, and the volume of the injected drug is converted into the volume of the space in the drug flow channel 3, and then several different specific positions of the first exhaust channels 4 can be set for the specific drug. During specific implementation, scale marks can also be set at different first exhaust channels 4 to prompt the user to open the first exhaust channel 4 at that location to correspond to the amount of drug to be injected. Of course, in some embodiments, the gaps between each first exhaust channel 4 are The distance can also be set according to other specific rules. It can meet the needs of quantitatively adjusting different drug injection amounts according to different first exhaust channels 4.

As shown in FIG3 , in an embodiment of the present application, when a plurality of first exhaust channels 4 are provided on the drug flow channel 3, a second exhaust channel 6 is provided between the last first exhaust channel 4 and the outlet of the drug flow channel 3 along the direction from the inlet to the outlet of the drug flow channel 3. When the microneedle 5 penetrates the user's skin, the pressure inside and outside the drug flow channel 3 is unbalanced. When the high-pressure gas (taking this as an example, the same below) moves to the position of the first exhaust channel 4, if the outlet of the first exhaust channel 4 there is opened, the gas will be discharged from the first exhaust channel 4 there, at which time the pressure inside and outside is balanced, and the drug no longer moves forward. In some special cases, for example, when the microneedle 5 penetrates the skin, the pressure inside and outside the flow channel is unbalanced, but at this time, no outlet of the first exhaust channel 4 is opened. At this time, the high-pressure gas will push the drug to flow forward all the time. When the high-pressure gas moves to the position of the second exhaust channel 6 in the flow channel, if the outlet of the second exhaust channel 6 is opened, the high-pressure gas will be passively discharged from the second exhaust channel 6, so that the high-pressure gas will not enter the microneedle module and the human body with the drug, thereby playing a role in safety protection for the user. In some embodiments, when a first exhaust channel 4 is provided on the drug flow channel 3, the second exhaust channel 6 is provided between the first exhaust channel 4 and the drug flow channel 3, which also plays a role in safety protection for the user.

In the embodiment of the present application, the inner diameter of the first exhaust channel 4 and the second exhaust channel 6 is less than or equal to the inner diameter of the flow channel. In specific implementation, the inner diameter range of the first exhaust channel 4 and the second exhaust channel 6 can be any value between 0.05 and 100 mm, for example: it can be 0.1 mm, 0.2 mm, ..., 1.0 mm, 1.1 mm, ..., 4.9 mm, 5 mm, ..., 99.9 mm, 100 mm.

In the embodiment of the present application, the inner diameters of the first exhaust channel 4 and the second exhaust channel 6 are continuously reduced from the inlet to the outlet. During the specific implementation, the specific inner diameters of the inlet and outlet ends of the first exhaust channel 4 and the second exhaust channel 6, as well as the specific changes in the inner diameters between the inlet and outlet ends, should be experimentally explored or calculated and designed in combination with the characteristics of the specific drugs, barrier fluids (see below), high-pressure gases, and drug flow channels 3. When the high-pressure gas is far away from the exhaust channel (referring to the first exhaust channel 4 and the second exhaust channel 6, the same below), under the action of pressure, the exhaust channel has a higher liquid level position. When the high-pressure gas pushes the drug forward gradually, the gas pressure gradually decreases, and the liquid level position gradually decreases; when the high-pressure gas advances to a position close to the exhaust channel, the liquid level in the exhaust channel gradually decreases to a position close to the inlet end of the flow channel. Based on the exhaust channel, the liquid level in the exhaust channel gradually decreases to a position close to the inlet end of the flow channel. The smooth design in which the inner diameter of the channel continuously decreases from the inlet end and the outlet end makes the connection between the exhaust channel and the drug flow channel 3 not a right angle, so that the remaining liquid in the exhaust channel can easily fall back into the drug flow channel 3 and continue to flow forward under the action of the high-pressure gas, rather than continuing to remain in the exhaust channel to block the exhaust channel. When the high-pressure gas reaches the exhaust channel position, it can be discharged smoothly, quickly and completely through the exhaust channel, thereby improving the accuracy of the injected drug dosage.

In the embodiment of the present application, a variable diameter cut-off point is provided on the first exhaust channel 4, and the inner diameter from the variable diameter cut-off point to the outlet end of the first exhaust channel 4 remains unchanged; a variable diameter cut-off point is provided on the second exhaust channel 6, and the inner diameter from the variable diameter cut-off point to the outlet end of the second exhaust channel 6 remains unchanged.

In the embodiment of the present application, the first exhaust channel 4 and the second exhaust channel 6 are integrated with the drug flow channel 3 to facilitate processing and manufacturing.

In the embodiment of the present application, the fluid control module also includes a first film layer 7 and a second film layer 8, and the outlets of all first exhaust channels 4 are provided with the first film layer 7 and the second film layer 8, and the second film layer 8 is located on the upper layer of the first film layer 7, and the outlet of the second exhaust channel 6 is provided with the first film layer 7, and the first film layer 7 is used to drive the medium to pass through and prevent the drug from flowing out, and the second film layer 8 is used to seal the outlet of the first exhaust channel 4. When in use, the second film layer 8 arranged at the outlet end of the first exhaust channel 4 is uncovered, and under the action of the driving medium in the driving medium storage chamber 1, the drug flows in the drug flow channel 3, and when the driving medium flows to the first exhaust channel 4 where the second film layer 8 is uncovered, the driving medium (volatile gas generated by high-pressure air or volatile liquid) is discharged through the first film layer 7 (the drug is blocked in the first film layer 7), and the internal and external pressures are balanced at this time, and the drug that loses the driving force no longer flows forward. In this way, the outlet of the first exhaust channel 4 can be quickly opened by setting the first film layer 7 and the second film layer 8, and the drug can be prevented from flowing out through the first exhaust channel 4 at the same time, and the operation is simple.

In the embodiment of the present application, all first film layers 7 are located on the same film layer for ease of preparation.

In the embodiment of the present application, the first film layer 7 is a hydrophobic breathable film, and the second film layer 8 is a sealing film. The material of the hydrophobic breathable film can be a single polymer material or a composite polymer material, and the polymer material can be polytetrafluoroethylene, fluorinated polyethylene, polyethylene, polypropylene, etc. The average pore size of the hydrophobic breathable film can be any value between 0.1 and 100 microns. The thickness of the hydrophobic breathable film can be any value between 10 and 10,000 microns. The hydrophobic semipermeable membrane is connected to the device by physical and chemical methods such as ultrasonic welding, mechanical connection or bonding. The second film layer 8 can be The sealing film can be a single polymer material or a composite polymer material. For example, the sealing film material can be polyurethane, polysulfide, acrylate, polyvinyl chloride, polymethyl methacrylate, ethylene-vinyl acetate copolymer, etc. The sealing film material can be a metal or alloy, for example, the sealing film material can be aluminum, magnesium, tin, tungsten, gold, silver, etc. The sealing film material can be paper, for example, oil paper, kraft paper, etc. The sealing film material can also be a ceramic material, a metal-ceramic compound material, etc.

In the embodiment of the present application, the average pore size of the hydrophobic breathable membrane is any value between 0.1 and 100 microns, which facilitates the passage of air or volatile gases and prevents the passage of drugs.

As shown in Figure 3, in an embodiment of the present application, the fluid control module also includes a barrier fluid storage portion 9, and the driving medium storage chamber 1, the barrier fluid storage portion 9 and the drug flow channel 3 are connected in sequence. When in use, the barrier fluid storage portion 9 is preset with a barrier fluid and ensures that the barrier fluid and the drug together fill the entire barrier fluid storage portion 9 and the drug flow channel 3. The barrier fluid is preferably a high-viscosity viscous fluid with a viscosity range of 103cP to 106cP at room temperature. For example, the viscous fluid has a viscosity range of 104cP to 5×105cP at room temperature, and the fluid is a non-Newtonian fluid with a viscosity range of 104cP to 2×105cP at room temperature. Non-Newtonian fluids may include one or more polymers exhibiting non-Newtonian properties, and solutions or multiphase mixtures thereof. The polymer may include one or more homopolymers, copolymers, terpolymers, and the like. The polymer may include repeating units derived from one or more polymerizable monomers, including olefins, cycloolefins, dienes, dienes, ethers, esters, amines, carboxylates, acetates, acrylic acid, methacrylic acid, acrylates, methacrylates, vinyl acetate, styrene, vinyl chloride, acrylonitrile, cyanoacrylate, tetrafluoroethylene, etc., and compositions of two or more thereof. A multiphase mixture may include two or more fluids that are immiscible, each of which may be organic, aqueous, or a combination thereof. A multiphase mixture may be an emulsion, and an emulsion may be a mixture of immiscible liquids, such as toothpaste. A multiphase mixture may be an oil-in-water or water-in-oil emulsion, and the oil may include a natural oil, a synthetic oil, or a mixture thereof. The natural oil may include animal oils, vegetable oils, and mineral oils. Animal oils may be lard. Vegetable oils may be saponifiable oils derived from triglycerides, such as castor oil, soybean oil, sesame oil, cottonseed oil, safflower oil, etc. Mineral oils may be aliphatic or paraffinic hydrocarbons, such as vaseline. The synthetic oil may be silicone oil.

In the embodiment of the present application, the barrier fluid storage portion 9 and the drug flow channel 3 are integrated to facilitate manufacturing.

As shown in Figures 4 and 5, in the embodiment of the present application, the microneedle module includes a plurality of microneedles 5; and also includes a transfer chamber 11, the transfer chamber 11 has an inner cavity for accommodating drugs, the transfer chamber 11 is connected to the drug flow channel 3, and the entrance of the microneedle 5 is connected to the inner cavity of the transfer chamber 11. The function of the transfer chamber 11 is mainly to serve as a "transfer station" for drugs, and the drugs flowing out of the outlet of the drug flow channel 3 are distributed here to each microneedle 5. The transfer chamber 11 can be located in the middle of the device, or in the edge area of the device, or at any position in the device. It should be noted that the entrance of the microneedle 5 can be directly connected to the transfer chamber 11, or indirectly connected through a connection mechanism that meets the requirements. Specifically, in this embodiment, a plurality of microneedles 5 are fixed on the same microneedle fixing seat 10, and the transfer chamber 11 is also arranged on the microneedle fixing seat 10. By arranging a plurality of microneedle flow channels 2 connected to the transfer chamber 11 on the microneedle fixing seat 10, the transfer chamber 11 is connected to the microneedle 5 by using the microneedle flow channel 2.

In some embodiments, the drug flow channel 3 and the microneedles 5 can also be connected in the following manner: the drug flow channel 3 includes a plurality of drug flow channel outlets corresponding to the number of microneedles 5, and the microneedles 5 are connected to the drug flow channel outlets in a one-to-one correspondence. In this way, drugs can be injected into the user simultaneously through multiple microneedles 5.

In an embodiment of the present application, the drug flow channel 3 is annular spiral or S-shaped (as shown in Figures 6-8). When the drug flow channel 3 is spiral, the driving medium storage chamber 1 can be set at the periphery of the drug flow channel 3. At this time, the driving medium pushes the drug from the outer ring to the inner ring; the driving medium storage chamber 1 can also be set in the central area of the drug flow channel 3; at this time, the driving medium pushes the drug from the inner ring to the outer ring. When the drug flow channel 3 is S-shaped, the turning point where the drug flow channel 3 changes direction is set as a curve rather than a broken line, which is conducive to the flow of drugs in the drug flow channel 3 and improves the accuracy of the drug injection amount. When the flow channel is linear or S-shaped, the transfer chamber 11 is located at the edge of the device below the flow channel outlet.

It should be noted that the cross section of the drug flow channel 3 can be circular, elliptical, square, rectangular, pentagonal, hexagonal, triangular, etc. In this embodiment, a circular cross section is used as an example. The inner diameter of the drug flow channel 3 can be any value between 0.1 and 100 mm, for example, 0.5 mm, 0.6 mm, ..., 1.1 mm, 1.2 mm, ..., 4.9 mm, 5 mm, ..., 99.9 mm, 100 mm.

In the embodiment of the present application, when the drug flow channel 3 is annular and spiral, the height of the drug flow channel 3 in the Z-axis direction gradually decreases from the inlet to the outlet of the drug flow channel 3. The drug flows in the drug flow channel 3 under the dual effects of air pressure and gravity, thereby improving the accuracy of drug injection amount.

In the embodiment of the present application, the microneedle module further includes a sealing mechanism for sealing the outlet of the microneedle 5, so as to seal the outlet of the microneedle 5 when the device is not in use to prevent the drug from flowing out.

In the embodiment of the present application, the sealing mechanism includes a sealing layer 12, and the sealing layer 12 covers the outlet end of the microneedle 5. It should be noted that the sealing layer 12 can be non-manually removable, such as a gel. When the needle tip of the microneedle 5 pierces the skin, the gel layer is broken under the action of an external force, thereby exposing the needle tip. The protective layer can also be manually removable, such as a protective film, and the needle tip of the microneedle 5 is exposed by manually removing the protective film.

The following is a detailed description of the use of the microneedle device of this embodiment.

During use, a driving medium is preset in the driving medium storage chamber 1, a barrier fluid is preset in the barrier fluid storage part 9, and a drug is preset in the drug flow channel, wherein the barrier fluid is used to separate the driving medium and the drug; the outlet of the microneedle 5 is opened manually or non-manually, and the driving medium pushes the drug to move in the drug flow channel 3 under the action of pressure, and the second film layer 8 arranged at different outlets of the first exhaust channel 4 is uncovered according to different usage requirements. When the driving medium flows to the first exhaust channel 4 where the second film layer 8 is uncovered, the driving medium (volatile gas generated by high-pressure air or volatile liquid) is discharged through the first film layer 7 (the drug is blocked in the first film layer 7). At this time, the internal and external pressures are balanced, and the drug that loses the driving force no longer flows forward, thereby realizing the control of the drug injection amount. It has a simple structure and is easy to operate.

It can be seen from the description of the above embodiments that the microneedle device provided by the present application has the following advantages:

The device as a whole abandons high-cost precision instrument components, electronic sensors, etc., has a simple structure, low cost, and is easy to promote. At the same time, the device can be started by a simple action of tearing the film, which is easy to operate, has good patient compliance, and can be used continuously for a long time. At the same time, by setting up multiple first exhaust channels 4, patients with different infusion volume requirements can be adapted in the same device, which greatly enhances the adaptability and ease of use of the device.

Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present application, rather than to limit them. Although the present application has been described in detail with reference to the above embodiments, ordinary technicians in this field should understand that they can still modify the technical solutions recorded in the above embodiments, or replace some of the technical features therein with equivalents; and these modifications or replacements are The replacement does not make the essence of the corresponding technical solution deviate from the scope of the technical solutions of the embodiments of the present application.

Claims

A microneedle device, comprising:

A fluid control module, the fluid control module comprising a driving medium storage chamber and a drug flow channel, the driving medium storage chamber and the drug flow channel are connected in sequence, and a first exhaust channel is provided on the drug flow channel;

A microneedle module comprises a microneedle, wherein the inlet end of the microneedle is connected to the outlet end of the drug flow channel.
The microneedle device according to claim 1, wherein at least one first exhaust channel is provided on the drug flow channel, and when a plurality of first exhaust channels are provided on the drug flow channel, the first exhaust channels are spaced apart along the axial direction of the drug flow channel.
The microneedle device according to claim 2, wherein when the drug flow channel is provided with a first exhaust channel, a second exhaust channel is provided between the first exhaust channel and the outlet of the drug flow channel;

When a plurality of the first exhaust channels are provided on the drug flow channel, a second exhaust channel is provided between the last of the first exhaust channels and the outlet of the drug flow channel along the direction from the inlet to the outlet of the drug flow channel.
The microneedle device according to claim 3, wherein the inner diameters of the first exhaust channel and the second exhaust channel continuously decrease from the inlet to the outlet.
The microneedle device according to claim 4, wherein a diameter-changing cut-off point is provided on the first exhaust channel, and the inner diameter from the diameter-changing cut-off point to the outlet end of the first exhaust channel remains unchanged;

The second exhaust passage is provided with a diameter-changing cut-off point, and the inner diameter from the diameter-changing cut-off point to the outlet end of the second exhaust passage remains unchanged.
The microneedle device according to claim 3, wherein the first exhaust channel and the second exhaust channel are integrated with the drug flow channel.
The microneedle device according to any one of claims 3 to 6, wherein the fluid control module further comprises a first film layer and a second film layer, the outlet of the first exhaust channel is provided with the first film layer and the second film layer, the second film layer is located on the upper layer of the first film layer, the outlet of the second exhaust channel is provided with the first film layer, the first film layer is used to drive the medium to pass through and prevent the drug from flowing out, and the second film layer is used to seal the outlet of the first exhaust channel.
The microneedle device according to claim 7, wherein all of the first film layers are located on the same film layer.
The microneedle device according to claim 7, wherein the first film layer is a hydrophobic breathable film, and the second film layer is a sealing film.
The microneedle device according to claim 9, wherein the average pore size of the hydrophobic breathable membrane is 0.1 to 100 microns.
The microneedle device according to claim 1, wherein the fluid control module further comprises a barrier fluid storage portion, and the driving medium storage chamber, the barrier fluid storage portion and the drug flow channel are connected in sequence.
The microneedle device according to claim 11, wherein the barrier fluid storage portion and the drug flow channel are integrated.
The microneedle device according to claim 1, wherein the microneedle module comprises a plurality of microneedles;

It also includes a transfer chamber, which has an inner cavity for accommodating drugs, the transfer chamber is connected to the drug flow channel, and the inlet of the microneedle is connected to the inner cavity of the transfer chamber.
The microneedle device according to claim 1, wherein the drug flow channel is an annular spiral or S-shaped.
The microneedle device according to claim 14, wherein, when the drug flow channel is annular and spiral, the height of the drug flow channel in the Z-axis direction gradually decreases from the inlet to the outlet of the drug flow channel.
The microneedle device according to claim 1, wherein the microneedle module further comprises a sealing mechanism for sealing an outlet of the microneedle.
The microneedle device according to claim 16, wherein the sealing mechanism comprises a sealing layer, and the sealing layer covers the outlet end of the microneedle.