CN118203751A

CN118203751A - Microneedle device

Info

Publication number: CN118203751A
Application number: CN202310048168.9A
Authority: CN
Inventors: 周翔君; 宋雨泽; 房劬; 王思勤; 金磊
Original assignee: Chongqing Jinsaixing Medical Technology Co ltd
Current assignee: Chongqing Jinsaixing Medical Technology Co ltd
Priority date: 2023-01-31
Filing date: 2023-01-31
Publication date: 2024-06-18

Abstract

The present invention provides a microneedle device comprising: the fluid control module comprises a driving medium storage chamber and a medicine flow passage, wherein the driving medium storage chamber and the medicine flow passage are sequentially connected, and a first exhaust passage is arranged on the medicine flow passage; the microneedle module comprises a microneedle, and the inlet end of the microneedle is communicated with the outlet end of the medicine flow channel. According to the microneedle device provided by the invention, through the combined action of the liquid control module and the microneedle module, when the microneedle device is used, the outlet of the first exhaust channel is opened, the driving medium in the driving medium storage chamber is released, the driving action is exerted on the medicine preset in the medicine flow channel through the driving medium preset in the driving medium storage chamber, and the medicine passes through the medicine flow channel under the driving pressure action of the driving medium to reach the microneedle for injecting the medicine to a user.

Description

Microneedle device

Technical Field

The invention relates to the technical field of medical instruments, in particular to a microneedle device.

Background

Currently, injection administration is one of the main routes of administration of drugs. However, for drugs that require home self-injection of patients, injection administration faces a series of problems that patients need professional training, fear of mind, safety, cross infection, etc., and thus, optimization of injection administration routes is a research field that is receiving a great deal of attention. Microneedles are a transdermal mechanical device that can penetrate the stratum corneum to form a drug delivery channel without stimulating the subcutaneous pain nerve. Compared with the conventional syringe subcutaneous injection, the drug effect of the microneedle injection is equal and even sometimes higher, and meanwhile, the problems faced by most injection administration can be overcome, the compliance of patients is higher, the fear of injection is less, and the safety is relatively higher.

In the prior art, some microneedle devices can start the device and injection flow only by external energy or substances, so that the device and the injection flow are inconvenient to use and difficult to use at any time and any place; some micro-needle device infusion opening modes depend on personal operation capability or accuracy of a patient, for example, the micro-needle device infusion opening modes are started by using a manual extrusion mode, and are influenced by pressing force, angles and the like, so that compliance of the patient is poor, and continuous use is difficult; some microneedle devices adopt precise mechanical components and electronic components to control transfusion, have complex structure and high cost, and are difficult to popularize; meanwhile, the medicine injection quantity of most of the existing microneedle drug delivery devices is fixed, cannot be selected, and is difficult to accurately adapt to different crowds. Namely, the existing microneedle devices have a great limitation.

Accordingly, there is a need for a microneedle device that can solve the above-described problems.

Disclosure of Invention

The invention provides a microneedle device which is simple in structure and convenient to operate.

The present invention provides a microneedle device comprising:

The fluid control module comprises a driving medium storage chamber and a medicine flow passage, wherein the driving medium storage chamber and the medicine flow passage are sequentially connected, and a first exhaust passage is arranged on the medicine flow passage;

The microneedle module comprises a microneedle, and the inlet end of the microneedle is communicated with the outlet end of the medicine flow channel.

According to the microneedle device provided by the invention, at least one first exhaust channel is arranged on the drug flow channel, and when a plurality of first exhaust channels are arranged on the drug flow channel, the first exhaust channels are arranged at intervals along the axial direction of the drug flow channel.

According to the microneedle device provided by the invention, when the first exhaust channel is arranged on the drug flow channel, the second exhaust channel is arranged between the first exhaust channel and the outlet of the drug flow channel;

When the medicine flow passage is provided with a plurality of first exhaust passages, a second exhaust passage is arranged between the last first exhaust passage and the outlet of the medicine flow passage along the direction from the inlet to the outlet of the medicine flow passage.

According to the microneedle device provided by the invention, the inner diameters of the first exhaust channel and the second exhaust channel continuously decrease along the inlet-to-outlet direction.

According to the microneedle device provided by the invention, the first exhaust channel is provided with the reducing cutoff point, and the inner diameter from the reducing cutoff point to the outlet end of the first exhaust channel is kept unchanged;

And a reducing cutoff point is arranged on the second exhaust passage, and the inner diameter from the reducing cutoff point to the outlet end of the second exhaust passage is kept unchanged.

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

According to the microneedle device provided by the invention, the fluid control module further comprises a first membrane layer and a second membrane layer, the first membrane layer and the second membrane layer are arranged at the outlet of the first exhaust channel, the second membrane layer is positioned on the upper layer of the first membrane layer, the first membrane layer is arranged at the outlet of the second exhaust channel, the first membrane layer is used for driving a medium to pass through and preventing a drug from flowing out, and the second membrane layer is used for sealing the outlet of the first exhaust channel.

According to the microneedle device provided by the invention, all the first film layers are positioned on the same film layer.

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

According to the microneedle device provided by the invention, the average pore size on the hydrophobic gas-permeable membrane is 0.1 to 100 micrometers.

According to the microneedle device provided by the invention, the fluid control module further comprises a barrier fluid storage part, and the driving medium storage chamber, the barrier fluid storage part and the drug flow channel are sequentially connected.

According to the microneedle device provided by the invention, the barrier fluid reservoir and the drug flow channel are integrally provided.

According to the microneedle device provided by the invention, the microneedle module comprises a plurality of microneedles;

still include the switching storehouse, the switching storehouse possesses the inner chamber that is used for holding the medicine, the switching storehouse with the medicine runner intercommunication, the entry of microneedle with the inner chamber intercommunication of switching storehouse.

According to the microneedle device provided by the invention, the drug flow channel is in a ring-shaped spiral shape or an S-shaped shape.

According to the microneedle device provided by the invention, when the drug flow channel is in the shape of a circular spiral, the height of the drug flow channel in the Z-axis direction is gradually reduced along the direction from the inlet to the outlet of the drug flow channel.

According to the microneedle device provided by the invention, the microneedle module further comprises a sealing mechanism for sealing the outlet of the microneedle.

According to the microneedle device provided by the invention, the sealing mechanism comprises a sealing layer, and the sealing layer covers the outlet end of the microneedle.

According to the microneedle device provided by the invention, through the combined action of the liquid control module and the microneedle module, when the microneedle device is used, the outlet of the first exhaust channel is opened, the driving medium in the driving medium storage chamber is released, the driving action is exerted on the medicine preset in the medicine flow channel through the driving medium preset in the driving medium storage chamber, and the medicine passes through the medicine flow channel under the driving pressure action of the driving medium to reach the microneedle for injecting the medicine to a user.

Additional aspects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention.

Drawings

In order to more clearly illustrate the invention or the technical solutions of the prior art, the following description will briefly explain the drawings used in the embodiments or the description of the prior art, and it is obvious that the drawings in the following description are some embodiments of the invention, and other drawings can be obtained according to the drawings without inventive effort for a person skilled in the art.

FIG. 1 is an isometric view of an embodiment of a microneedle device provided by the present invention;

FIG. 2 is a front view of an embodiment of a microneedle device provided by the present invention;

FIG. 3 is a top view (concealing the first and second film layers) of an embodiment of the microneedle device provided by the present invention;

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

FIG. 5 is an enlarged view of a portion of B in FIG. 4;

FIG. 6 is a front view of another embodiment of a microneedle device;

FIG. 7 is a schematic view of the internal structure of another embodiment of a microneedle device;

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

Reference numerals:

1. a driving medium storage chamber; 2. a microneedle flow channel; 3. a drug flow path; 4. a first exhaust passage; 5. a microneedle; 6. a second exhaust passage; 7. a first film layer; 8. a second film layer; 9. a barrier fluid reservoir; 10. a microneedle holder; 11, switching the bin; 12. and (3) a sealing layer.

Detailed Description

For the purpose of making the objects, technical solutions and advantages of the present invention more apparent, the technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings, and it is apparent that the described embodiments are some embodiments of the present invention, not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.

The microneedle device of the present invention is described below with reference to fig. 1 to 8.

As shown in fig. 1 to 3, the present invention provides a microneedle device comprising:

The fluid control module comprises a driving medium storage chamber 1 and a medicine flow channel 3, wherein the driving medium storage chamber 1 and the medicine flow channel 3 are sequentially connected, and a first exhaust channel 4 is arranged on the medicine flow channel 3;

The microneedle module comprises a microneedle 5, and the inlet end of the microneedle 5 is communicated with the outlet end of the medicine flow channel 3.

According to the microneedle device provided by the invention, through the combined action of the fluid control module and the microneedle module, when the microneedle device is used, the outlet of the first exhaust channel 4 is opened, the driving medium in the driving medium storage chamber 1 is released, the driving action is exerted on the medicine preset in the medicine flow channel 3 through the driving medium preset in the driving medium storage chamber 1, and the medicine passes through the medicine flow channel 3 under the driving pressure of the driving medium to reach the microneedle 5 for injecting the medicine to a user.

The driving medium storage chamber 1 may be square, rectangular, spherical, elliptical, cylindrical, conical, tubular, annular, or other irregular shape. The overall size of the device is between 0.1 and 100 cubic centimeters with a scale suitable for manual operation.

The driving medium storage chamber 1 is used for storing high-pressure gas or volatile gas, and the high-pressure gas can be a certain gas or a combination of several gases. Wherein the high pressure gas may be an inert gas selected from helium, neon, argon, krypton, xenon; the high pressure gas may be nitrogen, oxygen, carbon dioxide, sulfur hexafluoride, chlorofluorocarbon, fluorocarbon, nitrous oxide, nitrogen dioxide, propane, n-pentane, and the like. The volatile liquid may be a certain 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 the volatile liquid in the driving medium storage chamber 1 is 1 times or more of the atmospheric pressure, and can be any multiple of 1 to 100 times of the standard atmospheric pressure. For example: the pressure of the high pressure gas or volatile liquid may be 1.05 times, 1.1 times, 1.2 times, 1.3 times, … 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 medicine is in the form of liquid, such as aqueous solution, non-aqueous solution, suspension, emulsion, gel and cream; the medicine can be a small molecular medicine or a large molecular medicine. The small molecule drug may be protac (Proteolysis TARGETING CHIMERAS, proteolytically targeted chimeric) drug. Macromolecular drugs include polypeptides, proteins, monoclonal antibodies, diabodies, ADC drugs (Antibody-conjugated drugs). The drug may also be an RNA therapeutic drug, such as mRNA (messenger RNA), RNAi (RNA interference drug), siRNA (short interfering RNA), ASO (anti-streptolysin) and the like, a gene therapeutic drug, a gene editing drug. The medicine can also be Chinese medicine, chinese patent medicine, etc. The medicament may be a combination of the above medicaments. The medicine can be growth hormone, insulin, epinephrine, low molecular heparin, morphine, vaccine, local anesthetic, etc. The medicament may also include other adjuvants, such as preserving agents, solubilising agents/surfactants, buffers, isotonicity adjusting agents, suspending agents, dispersing agents, wetting agents and the like. The medicament may also include other active ingredients. The medicine is suitable for intradermal, subcutaneous, intramuscular injection and other administration.

The microneedles 5 may be metal microneedles, alloy microneedles, high polymer microneedles, silk fibroin microneedles, ceramic microneedles, silicon microneedles, graphene microneedles, or the like. The microneedles 5 may be solid microneedles, hollow microneedles, dissolvable microneedles, or the like. In the present embodiment, the microneedle 5 is exemplified as a hollow microneedle.

As shown in fig. 3, in the embodiment of the present invention, the medicine flow path 3 is provided with a plurality of first air discharge passages 4, and the plurality of first air discharge passages 4 are arranged at intervals along the axial direction of the medicine flow path 3. Through setting up a plurality of first exhaust passage 4 on medicine runner 3 interval, because the distance of different first exhaust passage 4 from driving medium apotheca 1 is different, when opening the export of different first exhaust passage 4, the position that driving medium release pressure in the driving medium apotheca 1 corresponds differently, can control the injection volume of medicine through the export control opening the first exhaust passage 4 of different positions to different patients are selected according to different user demands by oneself. Of course, in some embodiments, only one first air exhaust channel 4 may be provided on the medicine flow channel 3.

It should be noted that, the number of the first exhaust passages 4 is set according to actual needs, and the number thereof may be 1 to 10, or more than 10, depending on different usage gradients of the medicine for different users. When the number of the first exhaust passages 4 is greater than 1, the intervals of the plurality of first exhaust passages 4 on the flow passage are set at regular intervals.

The rule may be set at a distance, for example, assuming that the axial distance from the start point of the medicine flow channel 3 to the flow channel at the first exhaust passage 4 is L, the axial distance of the medicine flow channel 3 between the respective first exhaust passages 4 may be any value between L and 10L or any value above 10L, or may be any value below 0.05L or any value between 0.05L and L;

The rule may be set to a certain volume of the medicine flow path 3, for example, assuming that the flow path inner volume from the start point of the medicine flow path 3 to the first exhaust path 4 is V, the flow path inner volume between the first exhaust paths 4 may be any value between V and 10V or any value above 10V, or may be any value below 0.05V or any value between 0.05V and V.

The above arrangement is to facilitate that different first exhaust passages 4 correspond to different injection amounts of the medicine, so as to meet the injection requirements of different people on the medicine amount, especially to meet the different injection requirements of people with different weights or different ages on the medicine amount. For example, according to the usage amount of a specific drug in people with different weights, injection gears of several 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 specific positions of several different first exhaust channels 4 can be set for the specific drug. In specific implementation, scale marks can be further arranged at different positions of the first exhaust channels 4 and used for prompting a user to open the first exhaust channels 4 at the positions corresponding to the injected medicine amount. Of course, in some embodiments, the distance between the respective first exhaust passages 4 may be set according to other specific rules. Can meet the requirement of quantitatively adjusting different medicine injection amounts according to different first exhaust passages 4.

As shown in fig. 3, in the embodiment of the present invention, when a plurality of first air discharge channels 4 are provided on the medicine flow channel 3, a second air discharge channel 6 is provided between the last first air discharge channel 4 and the outlet of the medicine flow channel 3 along the direction from the inlet to the outlet of the medicine flow channel 3. When the microneedle 5 pierces the skin of a user, the pressure inside and outside the drug flow channel 3 is unbalanced, and when the high-pressure gas (for this example, the same applies below) moves to the position of the first gas discharge channel 4, if the outlet of the first gas discharge channel 4 is opened, the gas is discharged from the first gas discharge channel 4, and at this time, the pressure inside and outside is balanced, so that the drug is no longer moved forward. In some special cases, for example, when the micro needle 5 penetrates into the skin, the pressure inside and outside the runner is unbalanced, but the outlet of any first air exhaust channel 4 is not opened at this time, the high-pressure air pushes the medicine to flow forward all the time, when the high-pressure air moves to the position of the second air exhaust channel 6 in the runner, if the outlet of the second air exhaust channel 6 is opened, the high-pressure air is passively discharged from the second air exhaust channel 6, so that the high-pressure air cannot enter the micro needle module and the human body along with the medicine, and thus the safety protection effect is played for the user. In some embodiments, when the medicine flow channel 3 is provided with a first air exhaust channel 4, a second air exhaust channel 6 is arranged between the first air exhaust channel 4 and the medicine flow channel 3, so that the safety protection effect is also provided for a user.

In the embodiment of the present invention, the inner diameters of the first exhaust passage 4 and the second exhaust passage 6 are smaller than or equal to the inner diameter of the flow passage, and in a specific implementation, the inner diameters of the first exhaust passage 4 and the second exhaust passage 6 may be any value between 0.05 and 100 mm, for example: may be 0.1 mm, 0.2 mm, … mm, 1.0 mm, 1.1 mm, …, 4.9 mm, 5 mm, …, 99.9 mm, 100 mm.

In the embodiment of the present invention, the first exhaust passage 4 and the second exhaust passage 6 continuously decrease in inner diameter in the inlet-to-outlet direction. In a specific implementation, the specific inner diameters of the inlet end and the outlet end of the first exhaust passage 4 and the second exhaust passage 6, and the specific variation of the inner diameters between the inlet end and the outlet end should be combined with the characteristics of specific drugs, barrier fluids (see below), high-pressure gas, and drug flow channels 3 to make experimental investigation or computational design. When the high-pressure gas is far away from the exhaust channel (namely the first exhaust channel 4 and the second exhaust channel 6, the same applies below), the exhaust channel is provided with a higher liquid level position under the action of pressure, and when the high-pressure gas pushes the medicine to gradually advance, the pressure of the gas 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 be close to the inlet end of the flow channel, and the connection part between the exhaust channel and the medicine flow channel 3 is not at right angles based on the smooth design that the inner diameter of the exhaust channel continuously decreases from the direction of the inlet end and the direction of the outlet end, so that the residual liquid in the exhaust channel can fall back into the medicine flow channel 3 more easily and continuously flows forwards under the action of the high-pressure gas, and the exhaust channel is not continuously blocked by the residual liquid, so that the high-pressure gas can be smoothly, rapidly and completely discharged through the exhaust channel when reaching the position of the exhaust channel, and the precision of medicine injection quantity is improved.

In the embodiment of the invention, the first exhaust passage 4 is provided with a reducing cut-off point, and the inner diameter from the reducing cut-off point to the outlet end of the first exhaust passage 4 is kept unchanged; the second exhaust passage 6 is provided with a reducing cutoff point, and the inner diameter from the reducing cutoff point to the outlet end of the second exhaust passage 6 is kept unchanged.

In the embodiment of the present invention, the first exhaust passage 4 and the second exhaust passage 6 are provided integrally with the medicine flow path 3. Is convenient for processing and manufacturing.

In the embodiment of the present invention, the fluid control module further includes a first membrane layer 7 and a second membrane layer 8, the outlets of all the first exhaust channels 4 are provided with the first membrane layer 7 and the second membrane layer 8, the second membrane layer 8 is located on the upper layer of the first membrane layer 7, the outlet of the second exhaust channel 6 is provided with the first membrane layer 7, the first membrane layer 7 is used for driving the medium to pass through and preventing the medicine from flowing out, and the second membrane layer 8 is used for sealing the outlet of the first exhaust channel 4. When the medicine flow channel is used, the second membrane layer 8 arranged 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 medicine flows in the medicine flow channel 3, when the driving medium flows to the first exhaust channel 4 with the second membrane layer 8 uncovered, the driving medium (high-pressure air or volatile gas generated by volatile liquid) is discharged through the first membrane layer 7 (the medicine is blocked in the first membrane layer 7), and at the moment, the internal and external pressure is balanced, and the medicine losing the driving force does not flow forwards any more. Therefore, the first membrane layer 7 and the second membrane layer 8 can be used for rapidly opening the outlet of the first exhaust channel 4 and simultaneously preventing the medicine from flowing out through the first exhaust channel 4, so that the operation is simple and convenient.

In the present embodiment, all the first film layers 7 are located on the same film layer. Is convenient for preparation.

In the embodiment of the invention, the first film layer 7 is a hydrophobic and breathable film, and the second film layer 8 is a sealing film. The material of the hydrophobic and breathable film can be a polymer material or a composite polymer material of a single substance, and the polymer material can be polytetrafluoroethylene, fluorinated polyethylene, polypropylene and the like. The average pore size of the hydrophobic breathable film may be anywhere between 0.1 and 100 microns. The thickness of the hydrophobic breathable film may be anywhere between 10 to 10000 microns. The hydrophobic semipermeable membrane is connected with the device by adopting physical and chemical modes such as ultrasonic welding, mechanical connection or bonding and the like. The second film layer 8 may be a sealing film, and the sealing film material may be a polymer material of a single substance or a composite polymer material. For example, the sealing film material may be polyurethane, polysulfide, acrylate, polyvinyl chloride, polymethyl methacrylate, ethylene-vinyl acetate copolymer, or the like. The hermetic film material may be a metal or an alloy, and for example, the hermetic film material may be aluminum, magnesium, tin, tungsten, gold, silver, or the like. The sealing film material may be paper, for example, oiled paper, kraft paper, or the like. The sealing film material may also be a ceramic material, a metal-ceramic compound material, or the like.

In embodiments of the present invention, the average pore size on the hydrophobic breathable film is anywhere between 0.1 and 100 microns. Facilitating the passage of air or volatile gases and preventing the passage of medicaments.

As shown in fig. 3, in the embodiment of the present invention, the fluid control module further includes a barrier fluid reservoir 9, and the driving medium reservoir 1, the barrier fluid reservoir 9, and the medicine flow path 3 are sequentially connected. In use, the barrier fluid is preset in the barrier fluid reservoir 9 and ensures that the barrier fluid and the drug together fill the entire barrier fluid reservoir 9 and the interior of the drug channel 3. The barrier fluid is preferably a high viscosity, viscous fluid having a viscosity in the range of 10 ³ cP to 10 ⁶ cP at room temperature. For example, a viscous fluid has a viscosity in the range of 10 ⁴ cP to 5X 10 ⁵ cP at room temperature, and a non-Newtonian fluid having a viscosity in the range of 10 ⁴ cP to 2X 10 ⁵ cP at room temperature. The non-newtonian fluid can include one or more polymers that exhibit non-newtonian properties, as well as solutions or multiphase mixtures thereof. The polymer may comprise one or more homopolymers, copolymers, terpolymers, etc. The polymer may comprise repeat units derived from one or more polymerizable monomers including olefins, cyclic olefins, dienes, alkadienes, ethers, esters, amines, carboxylic acid esters, acetates, acrylic, methacrylic, vinyl acetate, styrene, vinyl chloride, acrylonitrile, cyanoacrylate, tetrafluoroethylene, and the like, and combinations of two or more thereof. The multiphase mixture may comprise two or more fluids that are immiscible, each of which may be organic, aqueous or a combination thereof. The multiphase mixture may be an emulsion, which may be a mixture of immiscible liquids, such as toothpaste. The multiphase mixture may be a water-in-oil or oil-in-water emulsion, and the oil may comprise a natural oil, a synthetic oil, or a mixture thereof. The natural oil may include animal oil, vegetable oil, and mineral oil. The animal oil may be lard. The vegetable oil may be saponifiable oil derived from triglycerides, such as castor oil, soybean oil, sesame oil, cottonseed oil, safflower oil, and the like. The mineral oil may be an aliphatic or paraffinic hydrocarbon such as petrolatum. The synthetic oil may be a silicone oil.

In the embodiment of the invention, the barrier fluid storage part 9 and the medicine flow channel 3 are integrated, so that the manufacturing is convenient.

As shown in fig. 4 and 5, in an embodiment of the present invention, the microneedle module includes a plurality of microneedles 5; the micro-needle device also comprises a transfer bin 11, wherein the transfer bin 11 is provided with an inner cavity for containing medicines, the transfer bin 11 is communicated with the medicine flow channel 3, and the inlet of the micro-needle 5 is communicated with the inner cavity of the transfer bin 11. The transfer magazine 11 acts primarily as a "transfer station" for one drug, where the drug exiting the outlet of the drug channel 3 is distributed to each microneedle 5. The adaptor chamber 11 may be located in the middle of the device, in the edge region of the device, or in any position within the device. It should be noted that, the inlet of the microneedle 5 may be directly connected to the adaptor housing 11, or may be indirectly connected to the adaptor housing through a connection mechanism according to the requirements. Specifically, in this embodiment, the plurality of microneedles 5 are fixed on the same microneedle fixing base 10, the switching bin 11 is also disposed on the microneedle fixing base 10, and the switching bin 11 is communicated with the microneedles 5 by disposing a plurality of microneedle runners 2 which are communicated with the switching bin 11 on the microneedle fixing base 10, and utilizing the microneedle runners 2.

In some embodiments, the drug channel 3 and the microneedle 5 may be further connected as follows: the medicine flow channel 3 comprises a plurality of medicine flow channel outlets which are in one-to-one correspondence with the number of the micro-needles 5, and the micro-needles 5 are connected with the medicine flow channel outlets in one-to-one correspondence. In this way, the user can be injected with the medicine through the plurality of microneedles 5 at the same time.

In the embodiment of the present invention, the drug flow channel 3 is in a spiral shape or an S-shape (as shown in fig. 6 to 8). When the medicine flow channel 3 is spiral, the driving medium storage chamber 1 can be arranged at the periphery of the medicine flow channel 3, and at the moment, the driving medium pushes the medicine to move from the outer ring to the inner ring; the drive medium reservoir 1 may also be arranged in the central region of the drug flow channel 3; at this point, the driving medium pushes the drug from the inner ring to the outer ring. When the medicine flow channel 3 is S-shaped, the turning position where the direction of the medicine flow channel 3 is changed is set to be a curve instead of a broken line, so that the medicine can flow in the medicine flow channel 3, and the accuracy of the medicine injection dosage is improved. When the flow channel is linear or S-shaped, the switching bin 11 is positioned at the edge of the device below the outlet of the flow channel.

The cross section of the drug flow channel 3 may be circular, oval, square, rectangular, pentagonal, hexagonal, triangular, or the like. In the present embodiment, a circular cross-sectional shape is taken as an example. The inner diameter of the drug flow channel 3 may be any value between 0.1 and 100 mm, for example: may be 0.5 mm, 0.6 mm, … mm, 1.1 mm, 1.2 mm, …, 4.9 mm, 5mm, …, 99.9 mm, 100 mm.

In the embodiment of the present invention, when the medicine flow path 3 is in a spiral shape, the height of the medicine flow path 3in the Z-axis direction is gradually reduced along the direction from the inlet to the outlet of the medicine flow path 3. So as to facilitate the medicine to flow in the medicine flow channel 3 under the dual actions of air pressure and gravity and improve the accuracy of the medicine injection dosage.

In an embodiment of the invention, the microneedle module further comprises a sealing mechanism for sealing the outlet of the microneedles 5. To seal the outlet end of the microneedle 5 from drug outflow when the device is not in use.

In an embodiment of the invention, the sealing mechanism comprises a sealing layer 12, the sealing layer 12 covering the outlet end of the micro needle 5. It should be noted that, the sealing layer 12 may be a non-manually removable type, such as a gel, and when the tips of the microneedles 5 pierce the skin, the gel layer breaks under an external force, thereby exposing the tips. The protective layer may also be manually removed, for example, a protective film, by which the tips of the microneedles 5 are exposed.

The following describes the use of the microneedle device of the present embodiment.

When in 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 medicine is preset in the medicine flow channel, wherein the barrier fluid is used for separating the driving medium and the medicine; the outlet of the microneedle 5 is opened manually or in a non-manual mode, the driving medium pushes the medicine to move in the medicine flow channel 3, the second film layers 8 arranged on the outlets of the different first exhaust channels 4 are uncovered according to different use requirements, when the driving medium flows to the first exhaust channels 4 of the uncovered second film layers 8, the driving medium (high-pressure air or volatile gas generated by volatile liquid) is discharged through the first film layers 7 (the medicine is blocked in the first film layers 7), at the moment, the internal pressure and the external pressure are balanced, the medicine losing the driving force does not flow forwards any more, and therefore the medicine injection quantity is controlled.

As can be seen from the description of the above embodiments, the microneedle device provided by the present invention includes the following advantages:

The device integrally abandons high-cost precise instrument elements, electronic sensors and the like, has simple structure and lower cost, and is easy to popularize. Meanwhile, the device can be started through the simple action of film tearing, the operation is simple and convenient, the compliance of a patient is good, and the device can be continuously used for a long time. Meanwhile, by arranging a plurality of first exhaust channels 4, patients with different transfusion demands can be adapted in the same device, and the adaptability and the use convenience of the device are greatly enhanced.

Finally, it should be noted that: the above embodiments are only for illustrating the technical solution of the present invention, and are not limiting; although the invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical scheme described in the foregoing embodiments can be modified or some technical features thereof can be replaced by equivalents; such modifications and substitutions do not depart from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A microneedle device, comprising:

2. The microneedle device of claim 1, wherein at least one of said first vent channels is provided on said drug channel, and wherein when a plurality of said first vent channels are provided on said drug channel, said first vent channels are disposed at intervals along the axial direction of said drug channel.

3. The microneedle device of claim 2, wherein when one of said first vent channels is provided on said drug channel, a second vent channel is provided between said first vent channel and an outlet of said drug channel;

4. A microneedle device according to claim 3, wherein the first and second exhaust channels decrease in inner diameter continuously in an inlet-to-outlet direction.

5. The microneedle device of claim 4, wherein a tapered cut-off point is provided on the first exhaust channel, the tapered cut-off point having a constant inner diameter to an outlet end of the first exhaust channel;

6. A microneedle device according to claim 3, wherein the first and second vent channels are provided integrally with the drug flow channel.

7. The microneedle device of any one of claims 3-6, wherein said fluid control module further comprises a first membrane layer and a second membrane layer, wherein said first membrane layer and said second membrane layer are disposed at an outlet of said first vent channel, wherein said second membrane layer is disposed at an upper layer of said first membrane layer, wherein said first membrane layer is disposed at an outlet of said second vent channel, wherein said first membrane layer is configured to drive a medium therethrough and to prevent a drug from exiting, and wherein said second membrane layer is configured to seal said outlet of said first vent channel.

8. The microneedle device of claim 7, wherein all of said first film layers are on the same film layer.

9. The microneedle device of claim 7, wherein said first membrane layer is a hydrophobic, breathable membrane and said second membrane layer is a sealing membrane.

10. The microneedle device of claim 9, wherein the average pore size on the hydrophobic gas permeable membrane is 0.1 to 100 microns.

11. The microneedle device of claim 1, wherein said fluid control module further comprises a barrier fluid reservoir, said drive medium reservoir, said barrier fluid reservoir, and said drug flow channel being connected in sequence.

12. The microneedle device of claim 11, wherein said barrier fluid reservoir and said drug flow channel are integrally provided.

13. The microneedle device of claim 1, wherein said microneedle module comprises a plurality of microneedles;

14. The microneedle device of claim 1, wherein the drug flow channel is spiral-shaped or S-shaped.

15. The microneedle device of claim 14, wherein when said drug flow channel is in a circular spiral shape, a height of said drug flow channel in a Z-axis direction is gradually reduced along an inlet-to-outlet direction of said drug flow channel.

16. The microneedle device of claim 1, wherein said microneedle module further comprises a sealing mechanism for sealing an outlet of said microneedle.

17. The microneedle device of claim 16, wherein said sealing mechanism comprises a sealing layer covering an outlet end of said microneedle.