Microneedle device

Abstract

The 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 being connected in sequence, and the drug flow channel being provided with a first exhaust passage; and a microneedle module, the microneedle module comprising microneedles, the inlet end of the microneedles being communicated with the outlet end of the drug flow channel. The microneedle device provided by the application is used by opening the outlet of the first exhaust passage and releasing the driving medium in the driving medium storage chamber, and the driving medium in the driving medium storage chamber is used to drive the drug preset in the drug flow channel, so that the drug reaches the microneedles through the drug flow channel under the driving pressure of the driving medium, and the drug is injected into the user, and the microneedle device has the advantages of simple structure and convenient operation.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a microneedle device. Background Art

[0002] 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, and it can overcome most of the problems faced by injection. Patients have higher compliance, less fear of injection, and relatively higher safety.

[0003] In existing technologies, some microneedle devices require external energy or substances to activate the device and the injection process, making them inconvenient and difficult to use anytime, anywhere. Some microneedle devices rely on the patient's individual operating ability or precision to activate the infusion, such as manual squeezing, which is affected by the pressure strength and angle, resulting in poor patient compliance and difficulty in continuous use. Some microneedle devices use sophisticated mechanical and electronic components to control the infusion, resulting in complex structures, high costs, and difficulty in promotion. 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. In other words, existing microneedle devices have significant limitations.

[0004] Therefore, there is an urgent need for a microneedle device that can solve the above problems. Summary of the Invention

[0005] The present invention provides a microneedle device with a simple structure and easy operation.

[0006] The present invention provides a microneedle device comprising:

[0007] 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 being connected in sequence, and the drug flow channel being provided with a first exhaust channel;

[0008] The microneedle module comprises a microneedle, wherein the inlet end of the microneedle is connected to the outlet end of the drug flow channel.

[0009] According to the microneedle device provided by the present invention, 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.

[0010] According to the microneedle device provided by the present invention, 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;

[0011] When a plurality of first exhaust channels are provided on the drug flow channel, a second exhaust channel is provided between the last first exhaust channel and the outlet of the drug flow channel along the direction from the inlet to the outlet of the drug flow channel.

[0012] According to the microneedle device provided by the present invention, the inner diameters of the first exhaust channel and the second exhaust channel decrease continuously from the inlet to the outlet.

[0013] According to the microneedle device provided by the present invention, 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;

[0014] A diameter-changing cut-off point is provided on the second exhaust channel, and the inner diameter from the diameter-changing cut-off point to the outlet end of the second exhaust channel remains unchanged.

[0015] According to the microneedle device provided by the present invention, the first exhaust channel and the second exhaust channel are integrated with the drug flow channel.

[0016] According to the microneedle device provided by the present invention, 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, and 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.

[0017] According to the microneedle device provided by the present invention, all of the first film layers are located on the same film layer.

[0018] According to the microneedle device provided by the present invention, the first film layer is a hydrophobic breathable film, and the second film layer is a sealing film.

[0019] According to the microneedle device provided by the present invention, the average pore size of the hydrophobic breathable membrane is 0.1 to 100 microns.

[0020] According to the microneedle device provided by the present invention, 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.

[0021] According to the microneedle device provided by the present invention, the barrier fluid storage portion and the drug flow channel are integrated.

[0022] According to the microneedle device provided by the present invention, the microneedle module includes a plurality of microneedles;

[0023] 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.

[0024] According to the microneedle device provided by the present invention, the drug flow channel is annular spiral or S-shaped.

[0025] According to the microneedle device provided by the present invention, 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.

[0026] According to the microneedle device provided by the present invention, the microneedle module further includes a sealing mechanism for sealing the outlet of the microneedle.

[0027] According to the microneedle device provided by the present invention, the sealing mechanism includes a sealing layer, and the sealing layer covers the outlet end of the microneedle.

[0028] The microneedle device provided by the present invention, 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. The driving medium preset in the driving medium storage chamber exerts a driving effect on the drug preset in the drug flow channel. Under the driving pressure of the driving medium, the drug passes through the drug flow channel and reaches the microneedle to inject the drug into the user. It has a simple structure and is easy to operate.

[0029] Additional aspects and advantages of the present invention will be set forth in part in the description which follows and, in part, will be obvious from the description which follows, or may be learned by practice of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] In order to more clearly illustrate the technical solutions in the present invention or the prior art, a brief introduction is 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 invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0031] Figure 1 is an isometric view of an embodiment of a microneedle device provided by the present invention;

[0032] Figure 2is a front view of an embodiment of a microneedle device provided by the present invention;

[0033] Figure 3 1 is a top view of an embodiment of a microneedle device provided by the present invention (the first film layer and the second film layer are hidden);

[0034] Figure 4 yes Figure 2 Middle AA section view;

[0035] Figure 5 yes Figure 4 A partial enlarged view of middle B;

[0036] Figure 6 is a front view of another embodiment of a microneedle device;

[0037] Figure 7 is a schematic diagram of the internal structure of another embodiment of a microneedle device;

[0038] Figure 8 is a cross-sectional view of another embodiment of a microneedle device.

[0039] Reference numerals:

[0040] 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 membrane layer; 8. Second membrane layer; 9. Barrier fluid storage part; 10. Microneedle fixing seat; 11 Transfer chamber; 12. Sealing layer. DETAILED DESCRIPTION

[0041] To make the objectives, technical solutions, and advantages of the present invention more clear, the technical solutions of the present invention will be clearly and completely described below in conjunction with the accompanying drawings. Obviously, the embodiments described are only some of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts shall fall within the scope of protection of the present invention.

[0042] The following combination Figures 1 to 8 The microneedle devices of the present invention are described.

[0043] like Figures 1 to 3 As shown, the present invention provides a microneedle device, comprising:

[0044] The fluid control module includes a driving medium storage chamber 1 and a drug flow channel 3, which are connected in sequence. The drug flow channel 3 is provided with a first exhaust channel 4;

[0045] The microneedle module includes a microneedle 5 , and the inlet end of the microneedle 5 is connected to the outlet end of the drug flow channel 3 .

[0046] The microneedle device provided by the present invention, 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. The driving medium preset in the driving medium storage chamber 1 exerts a driving effect on the drug preset in the drug flow channel 3. Under the driving pressure of the driving medium, the drug passes through the drug flow channel 3 and reaches the microneedle 5 to inject the drug into the user. It has a simple structure and is easy to operate.

[0047] 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 human operation and is between 0.1 and 100 cubic centimeters.

[0048] The driving medium storage chamber 1 is used to store high-pressure gas or volatile gas. The high-pressure gas can be a single gas or a combination of several gases. 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 single liquid or a combination of several liquids. The volatile liquid can be acetic acid, ethyl acetate, alcohol, etc. The pressure of the high-pressure gas or volatile liquid in the driving medium storage chamber 1 is greater than or equal to 1 times the standard 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, 1.1, 1.2, 1.3, ..., 2, 2.1, 2.2, ..., 9.8, 9.9, 10, ..., 99.9, or 100 times the standard atmospheric pressure.

[0049] The drug is in liquid dosage form and 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) drugs. Macromolecule drugs include peptides, proteins, monoclonal antibodies, bispecific antibodies, ADC drugs (Antibody to Drug Conjugate, antibody-drug conjugate). 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 multiple drugs mentioned above. The drug can be growth hormone, insulin, epinephrine, low molecular weight heparin, morphine, vaccine, local anesthetic, etc. The drug can also include other excipients, such as preservatives, solubilizers / surfactants, buffers, isotonicity 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.

[0050] The microneedles 5 can be metal microneedles, alloy microneedles, polymer microneedles, silk fibroin microneedles, ceramic microneedles, silicon microneedles, graphene microneedles, etc. The microneedles 5 can be solid microneedles, hollow microneedles, dissolvable microneedles, etc. In this embodiment, the microneedles 5 are hollow microneedles as an example.

[0051] like Figure 3 As shown, in an embodiment of the present invention, a plurality of first exhaust channels 4 are provided on the drug flow channel 3, and the plurality of first exhaust channels 4 are spaced apart along the axial direction of the drug flow channel 3. By providing 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 pressure release position of the driving medium in the driving medium storage chamber 1 is correspondingly different. By controlling the opening of the outlets of the first exhaust channels 4 at different positions, the injection amount of the drug can be controlled, thereby allowing different patients to choose according to their different usage needs. Of course, in some embodiments, only one first exhaust channel 4 can be provided on the drug flow channel 3.

[0052] It should be noted that the number of first exhaust channels 4 is set according to actual needs and is related to the different dosage gradients of the drug for different users. The number can be 1 to 10, or more than 10. When the number of 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.

[0053] The rule may be set according to 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 greater than 10L, or any value less than 0.05L or any value between 0.05L and L.

[0054] 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.

[0055] The above setting is to facilitate that different first exhaust channels 4 correspond to different drug injection volumes, so as to meet the injection requirements of different groups of people for drug volume, especially to meet the different injection requirements of people of different weights or different ages for drug volume. For example, according to the usage of a specific drug for 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, so that the specific positions of several different first exhaust channels 4 can be set for specific drugs. In 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 distance between each first exhaust channel 4 can also be set according to other specific rules. It is sufficient to be able to meet the needs of quantitatively adjusting different drug injection volumes according to different first exhaust channels 4.

[0056] like Figure 3As shown, in an embodiment of the present invention, 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 at that location is opened, the gas will be discharged from the first exhaust channel 4 at that location. At this time, the internal and external pressures are balanced and the drug no longer moves forward. In certain special circumstances, 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. 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 serves as a safety protection for the user.

[0057] In an embodiment of the present invention, 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.

[0058] In the embodiment of the present invention, the inner diameters of the first exhaust channel 4 and the second exhaust channel 6 decrease continuously from the inlet to the outlet. In practice, 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 variation in inner diameter between the inlet and outlet ends, should be determined through experimental exploration or computational design based on the characteristics of the specific drug, barrier fluid (see below), high-pressure gas, and drug flow channel 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 medicine forward gradually, the pressure of the gas gradually decreases, and the liquid level position gradually drops; when the high-pressure gas advances to a position close to the exhaust channel, the liquid level in the exhaust channel gradually drops to close to the inlet end of the flow channel. Based on the smooth design of the exhaust channel inner diameter continuously decreasing from the inlet end and the outlet end, the connection between the exhaust channel and the drug flow channel 3 is not a right angle, which can make the remaining liquid in the exhaust channel fall back into the drug flow channel 3 more easily, and continue to flow forward under the action of the high-pressure gas, rather than continuing to stay in the exhaust channel to block the exhaust channel, so that the high-pressure gas can be discharged smoothly, quickly and completely through the exhaust channel when it reaches the exhaust channel position, thereby improving the accuracy of the injected drug dosage.

[0059] In an embodiment of the present invention, a reducing cut-off point is provided on the first exhaust channel 4, and the inner diameter from the reducing cut-off point to the outlet end of the first exhaust channel 4 remains unchanged; a reducing cut-off point is provided on the second exhaust channel 6, and the inner diameter from the reducing cut-off point to the outlet end of the second exhaust channel 6 remains unchanged.

[0060] In the embodiment of the present invention, the first exhaust channel 4 and the second exhaust channel 6 are integrated with the drug flow channel 3 to facilitate processing and manufacturing.

[0061] In an embodiment of the present invention, the fluid control module further includes a first film layer 7 and a second film layer 8. The outlets of all first exhaust channels 4 are provided with the first film layer 7 and the second film layer 8, the second film layer 8 being located above the first film layer 7. The outlet of the second exhaust channel 6 is provided with the first film layer 7. The first film layer 7 is used to drive the medium 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 provided at the outlet end of the first exhaust channel 4 is uncovered. Under the action of the driving medium in the driving medium storage chamber 1, the drug flows in the drug flow channel 3. 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, having lost the driving force, no longer flows forward. In this way, the outlet of the first exhaust channel 4 can be quickly opened and the drug can be prevented from flowing out through the first exhaust channel 4 by providing the first film layer 7 and the second film layer 8, which is easy to operate.

[0062] In the embodiment of the present invention, all first film layers 7 are located on the same film layer, which facilitates preparation.

[0063] In an embodiment of the present invention, the first membrane layer 7 is a hydrophobic breathable membrane, and the second membrane layer 8 is a sealing membrane. The hydrophobic breathable membrane can be made of a single polymer or a composite polymer. The polymer can be polytetrafluoroethylene, fluorinated polyethylene, polyethylene, polypropylene, or the like. The average pore size of the hydrophobic breathable membrane can be anywhere between 0.1 and 100 microns. The thickness of the hydrophobic breathable membrane can be anywhere between 10 and 10,000 microns. The hydrophobic semipermeable membrane is connected to the device using physical or chemical methods such as ultrasonic welding, mechanical connection, or bonding. The second membrane layer 8 can be a sealing membrane. The sealing membrane can be made of a single polymer or a composite polymer. For example, the sealing membrane can be made of polyurethane, polysulfide, acrylate, polyvinyl chloride, polymethyl methacrylate, or ethylene-vinyl acetate copolymer. The sealing membrane can be made of a metal or alloy, such as aluminum, magnesium, tin, tungsten, gold, or silver. The sealing membrane can be made of paper, such as oil-proof paper or kraft paper. The sealing film material may also be ceramic material, metal-ceramic compound material, etc.

[0064] In an embodiment of the present invention, 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.

[0065] like Figure 3 As shown, in this embodiment of the present invention, the fluid control module further comprises a barrier fluid storage unit 9, and the driving medium storage chamber 1, the barrier fluid storage unit 9 and the drug flow channel 3 are sequentially connected. When in use, the barrier fluid storage unit 9 is pre-filled with a barrier fluid and the barrier fluid and the drug are combined to fill the entire barrier fluid storage unit 9 and the drug flow channel 3. The barrier fluid is preferably a high-viscosity viscous fluid with a viscosity range of 10 at room temperature. 3 cP to 10 6 cP. For example, a viscous fluid has a viscosity range of 10 at room temperature. 4 cP to 5×10 5 cP, the fluid has a viscosity range of 10 at room temperature 4 cP to 2×10 5Non-Newtonian fluids of the invention. Non-Newtonian fluids can include one or more polymers exhibiting non-Newtonian properties, and solutions or multiphase mixtures thereof. Polymers can include one or more homopolymers, copolymers, terpolymers, etc. The polymer can 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. Multiphase mixtures can include two or more fluids that are immiscible, each fluid can be organic, aqueous, or a combination thereof. Multiphase mixtures can be emulsions, and emulsions can be mixtures of immiscible liquids, such as toothpaste. Multiphase mixtures can be water-in-oil or oil-in-water emulsions, and the oil can include natural oils, synthetic oils, or mixtures thereof. The natural oil can include animal oils, vegetable oils, and mineral oils. The animal oil can be lard. The vegetable oil can be a saponifiable oil derived from triglycerides, such as castor oil, soybean oil, sesame oil, cottonseed oil, safflower oil, etc. The mineral oil can be an aliphatic or paraffinic hydrocarbon, such as petrolatum. The synthetic oil can be a silicone oil.

[0066] In the embodiment of the present invention, the barrier fluid storage portion 9 and the drug flow channel 3 are integrated into one body, which is convenient for manufacturing.

[0067] like Figure 4 and Figure 5 As shown, in an embodiment of the present invention, the microneedle module includes a plurality of microneedles 5 and a transfer chamber 11. The transfer chamber 11 has an inner cavity for accommodating the drug. The transfer chamber 11 is connected to the drug flow channel 3, and the inlet of the microneedle 5 is connected to the inner cavity of the transfer chamber 11. The transfer chamber 11 primarily serves as a "transfer station" for the drug, distributing the drug flowing out of the outlet of the drug flow channel 3 to each microneedle 5. The transfer chamber 11 can be located in the middle of the device, at the edge of the device, or anywhere else within the device. It should be noted that the inlet of the microneedle 5 and the transfer chamber 11 can be connected directly or indirectly via a suitable connection mechanism. Specifically, in this embodiment, the plurality of microneedles 5 are fixed to the same microneedle holder 10, and the transfer chamber 11 is also disposed on the microneedle holder 10. By providing a plurality of microneedle flow channels 2 on the microneedle holder 10 that communicate with the transfer chamber 11, the transfer chamber 11 is connected to the microneedle 5 via the microneedle flow channels 2.

[0068] In some embodiments, the drug flow channel 3 and the microneedles 5 can be connected in the following manner: the drug flow channel 3 includes multiple 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, the drug can be injected into the user simultaneously through multiple microneedles 5.

[0069] In the embodiment of the present invention, the drug flow channel 3 is an annular spiral or S-shaped (eg Figure 6-8 As shown). When the drug flow channel 3 is spiral, the driving medium storage chamber 1 can be set on the periphery of the drug flow channel 3. In this case, 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. In this case, 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 the drug in the drug flow channel 3 and improves the accuracy of the drug injection amount. When the flow channel is straight or S-shaped, the transfer chamber 11 is located at the edge of the device below the flow channel outlet.

[0070] 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, or 100 mm.

[0071] In the embodiment of the present invention, 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. This facilitates the flow of the drug in the drug flow channel 3 under the dual effects of air pressure and gravity, thereby improving the accuracy of the drug injection dosage.

[0072] In an embodiment of the present invention, 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.

[0073] In this embodiment of the present invention, the sealing mechanism includes a sealing layer 12, which 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 microneedle 5 tip pierces the skin, the gel layer breaks under the action of external force, thereby exposing the needle tip. The protective layer can also be manually removable, such as a protective film, which is manually removed to expose the microneedle 5 tip.

[0074] The following is a detailed description of the use of the microneedle device of this embodiment.

[0075] 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. The second film layer 8 arranged on the outlet of different first exhaust channels 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.

[0076] From the description of the above embodiments, it can be seen that the microneedle device provided by the present invention has the following advantages:

[0077] The device as a whole dispenses with expensive precision instrument components and electronic sensors, resulting in a simple structure, low cost, and ease of adoption. The device can be activated simply by tearing off the membrane, making it easy to operate, ensuring good patient compliance, and enabling long-term, continuous use. Furthermore, by providing multiple first exhaust channels 4, the same device can accommodate patients with varying infusion volume requirements, significantly enhancing the device's adaptability and ease of use.

[0078] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or make equivalent replacements for some of the technical features therein. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the various embodiments of the present invention.

Claims

1. A microneedle device, characterized in that include: 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 being connected in sequence, and the drug flow channel being provided with a first exhaust channel; A microneedle module, comprising a microneedle, wherein an inlet end of the microneedle is connected to an outlet end of the drug flow channel; At least one first exhaust channel is provided on the drug flow channel, and a second exhaust channel is provided between the last first exhaust channel and the outlet of the drug flow channel along the direction from the inlet to the outlet of the drug flow channel; The fluid control module further includes a first film layer and a second film layer. The first film layer and the second film layer are provided at the outlet of the first exhaust channel. 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. The second film layer is used to seal the outlet of the first exhaust channel. 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 sequentially connected.

2. The microneedle device according to claim 1, wherein 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.

3. The microneedle device according to claim 1, wherein The inner diameters of the first exhaust passage and the second exhaust passage continuously decrease from the inlet to the outlet.

4. The microneedle device according to claim 3, 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; A diameter-changing cut-off point is provided on the second exhaust channel, and the inner diameter from the diameter-changing cut-off point to the outlet end of the second exhaust channel remains unchanged.

5. The microneedle device according to claim 1, wherein The first exhaust channel and the second exhaust channel are integrated with the drug flow channel.

6. The microneedle device according to claim 1, wherein All of the first film layers are located on the same film layer.

7. The microneedle device according to claim 1, wherein The first film layer is a hydrophobic breathable film, and the second film layer is a sealing film.

8. The microneedle device according to claim 7, wherein The average pore size of the hydrophobic breathable membrane is 0.1 to 100 microns.

9. The microneedle device according to claim 1, wherein The barrier fluid storage portion and the drug flow channel are integrated.

10. The microneedle device according to claim 1, wherein 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.

11. The microneedle device according to claim 1, wherein The drug flow channel is annular spiral or S-shaped.

12. The microneedle device according to claim 11, 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.

13. The microneedle device according to claim 1, wherein The microneedle module further includes a sealing mechanism for sealing the outlet of the microneedle.

14. The microneedle device according to claim 13, wherein The sealing mechanism includes a sealing layer, and the sealing layer covers the outlet end of the microneedle.

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