Microneedle device

Abstract

The utility model relates to the technical field of medical instruments, and discloses a microneedle device which comprises a microneedle unit and a wearing unit, the microneedle unit comprises a first containing cavity, a communicating hole communicated with the first containing cavity is formed in the microneedle unit, and the microneedle unit is used for puncturing the interior of a part to be punctured so that the communicating hole can be communicated with the interior of the part to be punctured; the wearing unit is connected with the microneedle unit and used for enabling the microneedle unit to be detachably arranged on a to-be-punctured part. According to the utility model, the wearing unit is arranged and can be detachably arranged on the surface of the to-be-punctured part, so that the microneedle unit is fixed on the to-be-punctured part, and further, the microneedle unit is stably communicated with the to-be-punctured part. Compared with the prior art that the microneedle array is fixed on the to-be-punctured part through a medical adhesive tape, the wearing unit does not need to be pasted on the surface of the to-be-punctured part, fixation between the microneedle unit and the to-be-punctured part can also be achieved, the to-be-punctured part is prevented from being endowed with the dragging feeling, and the puncturing effect of the to-be-punctured part is improved. Therefore, the technical effect of improving the use comfort of the microneedle unit is achieved.

Description

TECHNICAL FIELD

[0001] The utility model relates to medical instrument technical field, concretely relates to micro needle device. BACKGROUND

[0002] Skin is the largest organ of the human body, mainly composed of epidermis, dermis and subcutaneous tissue. There is a rich interstitial fluid (ISF) in the dermis layer. ISF is filtered from blood through the capillaries of subcutaneous tissue, and its composition is similar to plasma, containing rich biomarkers, which can reflect the functional state of the human body, disease development process and inflammatory reaction degree. At the same time, compared with the traditional intravenous or fingertip blood sampling method, ISF extraction has the advantages of minimally invasive, painless and low risk of infection. Therefore, ISF is regarded as a kind of body fluid sample which is expected to replace blood and the like, for disease diagnosis, prognosis evaluation and drug level monitoring.

[0003] The existing micro needle device includes: a micro needle array including a base and a plurality of micro needles arranged at intervals of microns, the plurality of micro needles are fixedly connected with the base, each micro needle is a hollow structure, the micro needle is pierced into the skin of the human body, and sampling is carried out through the capillary action of the micro needle hole. Specifically, when the existing micro needle array is sampling, when the position of the skin at the sampling position moves, the micro needle array is prone to falling, which affects the sampling process. Therefore, the micro needle array needs to be fixed on the skin of the person to be extracted by the medical tape, but when the medical tape is torn, the skin of the person to be extracted is prone to be pulled, which reduces the comfort of using the micro needle device. SUMMARY

[0004] Therefore, the utility model provides a kind of micro needle device to solve the problem that the existing micro needle device needs medical tape to be fixed on the skin of the person to be extracted, and when the medical tape is torn, the skin of the person to be extracted is pulled, which reduces the comfort of using the micro needle device.

[0005] The utility model provides a kind of micro needle device, comprising:

[0006] The micro needle unit includes a first receiving cavity, and a communication hole is provided on the micro needle unit and communicates with the first receiving cavity, and the micro needle unit is used to pierce into the inside of the part to be pierced so that the communication hole communicates with the inside of the part to be pierced.

[0007] The wearing unit is connected with the micro needle unit, and the wearing unit is used to detachably connect the micro needle unit with the part to be pierced.

[0008] Beneficial effects: by setting the wearing unit, the wearing unit is detachable on the surface of the to-be-pierced part, so as to fix the microneedle unit on the to-be-pierced part, and further make the microneedle unit and the to-be-pierced part stably communicate. Compared with the related art that the microneedle array is fixed on the to-be-pierced part by the medical tape, the wearing unit in the utility model does not need to be pasted on the surface of the to-be-pierced part, and can also realize the fixation between the microneedle unit and the to-be-pierced part, avoid giving the to-be-pierced part a pulling feeling, and thus the technical effect of improving the comfort of the microneedle unit is achieved.

[0009] In an alternative embodiment, the wearing unit comprises:

[0010] a shell, the shell being provided with a second accommodating cavity, and the microneedle unit being arranged in the second accommodating cavity;

[0011] a first connecting structure, one end of the first connecting structure being connected with one end of the shell, and the other end of the first connecting structure being a first free end;

[0012] a second connecting structure, one end of the second connecting structure being connected with the other end of the shell, and the other end of the second connecting structure being a second free end, the second free end being connected with the first free end and being used for fixing with the to-be-pierced part.

[0013] Beneficial effects: by setting the first connecting structure and the second connecting structure, the first free end of the first connecting structure and the second free end of the second connecting structure are connected, the shell can be fixed on the to-be-pierced part, that is, the microneedle unit is fixed on the to-be-pierced part, and thus the stability of the microneedle structure in extracting the tissue fluid of the to-be-pierced part is improved.

[0014] In an alternative embodiment, the first free end and the second free end are detachably connected;

[0015] And / or, one end of the first connecting structure and the shell are detachably connected;

[0016] And / or, the other end of the second connecting structure and the shell are detachably connected;

[0017] And / or, the first connecting structure and / or the second connecting structure have elasticity;

[0018] And / or, the length of the first connecting structure and / or the second connecting structure is adjustable;

[0019] And / or, the microneedle unit and the shell are detachably connected;

[0020] And / or, the material of the shell is one or a combination of flexible silica gel, thermoplastic polymer material, ABS engineering plastic, polypropylene, polyvinyl chloride, polyurethane, silicone material, polycarbonate, hard polyethylene and resin.

[0021] Beneficial effect: by setting the detachable connection between the first free end and the second free end, the microneedle unit can be directly placed at the to-be-pierced part without the need for multiple adjustments of the position of the microneedle unit, thereby achieving the technical effect of improving the convenience of detachable connection of the wearing unit with the to-be-pierced part.

[0022] By detachable connection of the first connecting structure with one end of the shell and detachable connection of the second connecting structure with the other end of the shell, the first connecting structure and the second connecting structure can be replaced as needed, thereby achieving the technical effect of improving the convenience of use of the first connecting structure and the second connecting structure.

[0023] By limiting the first connecting structure and the second connecting structure to have elasticity, the first connecting structure and the second connecting structure can be adapted to the size of different to-be-pierced parts, thereby achieving the technical effect of improving the adaptability of the microneedle device.

[0024] By limiting the length of the first connecting structure and the second connecting structure to be adjustable, based on this, the length of the first connecting structure and the second connecting structure can be adjusted according to the size of the to-be-pierced part, thereby achieving the technical effect of improving the convenience of use of the microneedle device.

[0025] By detachable connection of the microneedle unit with the shell, based on this, when collecting the tissue fluid of different people, only the microneedle unit needs to be replaced, without the need to replace the entire microneedle device, thereby achieving the technical effect of reducing the use cost of the microneedle device.

[0026] In an alternative embodiment, the microneedle device comprises:

[0027] The driving unit is arranged in the second accommodating cavity, and the driving unit comprises a first pipeline and a driving structure, the driving structure is in communication with one end of the first pipeline, the other end of the first pipeline is in communication with the first accommodating cavity, and the driving unit is used to drive the liquid inside the to-be-pierced part to flow into the microneedle unit.

[0028] Beneficial effect: by the driving structure, the tissue fluid inside the to-be-pierced part can be given power to enter the first pipeline, so that the tissue fluid can quickly enter the third accommodating cavity and the first pipeline through the communication hole and the first accommodating cavity, thereby achieving the technical effect of improving the work efficiency of collecting the tissue fluid inside the to-be-pierced part.

[0029] In an alternative embodiment, the driving unit comprises:

[0030] a second pipeline, one end of the second pipeline being in communication with the driving structure, the other end of the second pipeline being in communication with the outside world;

[0031] And / or, the microneedle device comprises:

[0032] a control unit, the control unit being in communication connection with the driving structure, for controlling the opening and closing of the driving structure, and adjusting the working mode of the driving structure.

[0033] Beneficial effect: by setting the second pipeline, the second pipeline can be in communication with the outside world, and the tissue fluid can be driven to the outside world through the driving structure as needed, so as to achieve the technical effect of improving the convenience of using the microneedle device.

[0034] Through the automatic control of the working mode by the control unit, the intelligent control of the driving structure is improved.

[0035] In an alternative embodiment, the microneedle device comprises:

[0036] a storage unit, the storage unit being in communication with the other end of the second pipeline, for storing the liquid in the to-be-pierced part or storing the liquid from the outside world.

[0037] Beneficial effect: by setting the storage unit, the capacity of the microneedle device can be further improved, so as to achieve the technical effect of improving the capacity of the tissue fluid or the liquid from the outside world.

[0038] In an alternative embodiment, the microneedle device comprises:

[0039] a detection unit, comprising a detection structure and a display structure, the detection structure being in communication with the other end of the second pipeline and / or the storage unit, for detecting the biomarker of the liquid in the to-be-pierced part, the display structure being in communication connection with the detection structure, for displaying the detection result.

[0040] Beneficial effect: by setting the detection unit, the biomarker in the tissue fluid can be detected without other large equipment, so as to achieve the technical effect of improving the convenience of detecting the biomarker in the tissue fluid.

[0041] In an alternative embodiment, the microneedle device comprises:

[0042] a power supply unit, electrically connected with the control unit and / or the driving unit, for supplying power to the control unit and / or the driving unit.

[0043] Beneficial effects: without connecting external power supply, so that the microneedle device can be used in the environment without power supply, such as outdoor, to achieve the technical effect of improving the convenience of microneedle device power supply.

[0044] In an alternative embodiment, the microneedle unit comprises:

[0045] The base is at least partially disposed in the second accommodating cavity and connected with the shell;

[0046] A plurality of spaced microneedle structures, each of which is connected with the base, and the first accommodating cavity is provided in the microneedle structure.

[0047] Beneficial effects: by setting the base, the position of the plurality of microneedle structures can be fixed. Based on this, when the microneedle structure is fixed with the wearing unit, the fixation between the microneedle structure and the wearing unit can be realized through the fixation between the base and the wearing unit, thereby achieving the technical effect of improving the convenience of connection. By setting a plurality of microneedle structures, compared with only setting one microneedle structure, the extraction amount of tissue fluid of the plurality of microneedle structures is larger at the same time, thereby achieving the technical effect of improving the extraction speed.

[0048] In an alternative embodiment, the base comprises a third accommodating cavity, and the third accommodating cavity is in communication with the communication hole.

[0049] Beneficial effects: the third accommodating cavity can increase the space of the microneedle unit for accommodating tissue fluid, thereby achieving the technical effect of improving the ability of the microneedle unit to collect tissue fluid. BRIEF DESCRIPTION OF DRAWINGS

[0050] In order to more clearly illustrate the specific embodiments of the present application or the technical solutions in the prior art, the following will briefly introduce the drawings needed to be used in the specific embodiments or the prior art description. Obviously, the drawings described below are some embodiments of the present application, and those skilled in the art can also obtain other drawings according to these drawings without creative labor.

[0051] Figure 1 It is the front view of the microneedle device of the present embodiment;

[0052] Figure 2 It is the structure schematic view of the microneedle device of the present embodiment;

[0053] Figure 3 It is the structure schematic view between the microneedle unit, the driving unit, the control unit, the power supply unit and the charging port in the microneedle device of the present embodiment Figure 1 ;

[0054] Figure 4Structure diagram of the microneedle unit in the microneedle device of the embodiment Figure 2 ;

[0055] Figure 5 Structure diagram of the microneedle unit in the microneedle device of the embodiment

[0056] Figure 6 Results of extraction test of the microneedle device of the embodiment on a 1.2% agarose gel skin model

[0057] Figure 7 Structure diagram of the microneedle device of the embodiment worn on an SD (Sprague-Dawley) rat

[0058] Figure 8 Results of extraction test of the microneedle device of the embodiment on an SD rat

[0059] Explanation of reference signs:

[0060] 1, microneedle unit; 101, microneedle structure; 102, base; 103, communication hole; 104, third pipeline

[0061] 2, wearing unit; 201, shell; 2011, body; 2012, cover

[0062] 202, first connecting structure; 2021, first free end

[0063] 203, second connecting structure; 2031, second free end

[0064] 204, hole

[0065] 3, driving unit; 301, first pipeline; 302, driving structure; 303, second pipeline

[0066] 4, control unit; 401, reset button; 5, power supply unit; 6, charging port; 7, display structure DETAILED DESCRIPTION

[0067] In order to make the purpose, technical scheme and advantages of the embodiments of the present application more clear, the technical scheme of the embodiments of the present application will be described clearly and completely below in combination with the drawings in the embodiments of the present application. Obviously, the described embodiments are part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without making creative efforts fall within the scope of protection of the present application.

[0068] The embodiments of the present application will be described below in combination with the drawings Figures 1 to 8The embodiment of the utility model discloses.

[0069] According to the embodiment of the utility model, a microneedle device is provided, comprising:

[0070] The microneedle unit 1 comprises a first accommodating cavity, and the microneedle unit 1 is provided with a communication hole 103 in communication with the first accommodating cavity.

[0071] The wearing unit 2 is connected with the microneedle unit 1, and the wearing unit 2 is used for detachably arranging the microneedle unit 1 on the part to be pricked.

[0072] In the microneedle device of the embodiment, the wearing unit 2 is detachably arranged on the surface of the part to be pricked, so that the microneedle unit 1 is fixed on the part to be pricked, and the microneedle unit 1 is stably communicated with the part to be pricked.

[0073] In the embodiment, the microneedle unit 1 can be used for extracting tissue fluid under the epidermis of human body and other organisms.

[0074] In addition, in combination with Figure 1 and Figure 2 In the embodiment, the wearing unit 2 comprises:

[0075] The shell 201 is provided with a second accommodating cavity, and the second accommodating cavity is provided with the microneedle unit 1.

[0076] The first connecting structure 202 is connected with one end of the shell 201, and the other end of the first connecting structure 202 is a first free end 2021.

[0077] The second connecting structure 203 is connected with the other end of the shell 201, and the other end of the second connecting structure 203 is a second free end 2031.

[0078] By setting the first connecting structure 202 and the second connecting structure 203, connecting between the first free end 2021 of the first connecting structure 202 and the second free end 2031 of the second connecting structure 203, the shell 201 can be fixed on the to-be-pierced part, that is, the microneedle unit 1 is fixed on the to-be-pierced part, so as to improve the stability of the microneedle unit 1 to extract the tissue fluid of the to-be-pierced part.

[0079] The shell 201 includes a body 2011 and a cover 2012, the body 2011 includes a second accommodating cavity, and the cover 2012 is detachably connected with the body 2011. Specifically, the cover 2012 is detachably connected with the body 2011 through buckling, which is a mature technology and will not be described in detail here. Based on this, the structure in the second accommodating cavity can be disassembled and replaced by disassembling the cover 2012 and the body 2011. Of course, in other embodiments, the detachable manner between the cover 2012 and the body 2011 can be adjusted according to the design of the microneedle device.

[0080] Further, the microneedle unit 1 is detachably connected with the shell 201. Based on this, when collecting the tissue fluid of different people, only the microneedle unit 1 needs to be replaced, without replacing the entire microneedle device, thereby achieving the technical effect of reducing the use cost of the microneedle device.

[0081] Of course, according to actual needs, for example, when the wear of the microneedle unit 1 is too large, the microneedle unit 1 can be replaced. As a convertible embodiment, the microneedle unit 1 can be fixedly connected with the shell 201.

[0082] Specifically, the microneedle unit 1 is detachably connected with the shell 201 through buckling, which is a mature technology and will not be described in detail here. Of course, in other embodiments, the detachable connection manner between the microneedle unit 1 and the shell 201 can be adjusted according to the design of the microneedle device.

[0083] Preferably, the first connecting structure 202 and the second connecting structure 203 have elasticity, so that the first connecting structure 202 and the second connecting structure 203 can adapt to the size of different to-be-pierced parts, thereby achieving the technical effect of improving the adaptability of the microneedle device. As a convertible embodiment, the first connecting structure 202 or the second connecting structure 203 can have elasticity, or neither the first connecting structure 202 nor the second connecting structure 203 has elasticity.

[0084] Further, in the embodiment, the first free end 2021 and the second free end 2031 are detachably connected. Of course, in other embodiments, the first free end 2021 and the second free end 2031 can be fixedly connected, at which time the wearing unit 2 needs to be sleeved on the part to be pierced, that is, the position of the wearing unit 2 needs to be adjusted multiple times so that the position of the microneedle unit 1 can correspond to the part to be pierced. Compared with other embodiments, in the embodiment, the microneedle unit 1 can be directly placed at the part to be pierced, without the need to adjust the position of the wearing unit 2 multiple times, that is, the detachable connection of the wearing unit 2 on the part to be pierced can be completed, thereby achieving the technical effect of improving the convenience of detachable connection of the wearing unit 2 on the part to be pierced.

[0085] Among them, the first free end 2021 and the second free end 2031 can be detachably connected through a snap fastener. Specifically, the first free end 2021 is provided with a plurality of snap fasteners, and the second free end 2031 is provided with one female buckle, and one snap fastener is selected to be connected with the female buckle according to the size of the part to be pierced. As a convertible embodiment, the first free end 2021 can be provided with one snap fastener, and the second free end 2031 can be provided with a plurality of female buckles.

[0086] Of course, in other embodiments, the detachable connection mode between the first free end 2021 and the second free end 2031 can be adjusted according to the design of the microneedle device. For example, the first free end 2021 and the second free end 2031 are connected on the part to be pierced through an external force, so as to realize the fixation of the microneedle unit 1 on the part to be pierced.

[0087] In addition, in the embodiment, the first connecting structure 202 is detachably connected with one end of the shell 201, and the second connecting structure 203 is detachably connected with the other end of the shell 201. Among them, the first connecting structure 202 and the shell 201, and the second connecting structure 203 and the shell 201 are both provided with a communication hole 103, and the spring rod passes through the communication hole 103, so as to realize the detachable connection between the first connecting structure 202 and the shell 201, and the second connecting structure and the shell 201. Based on this, the first connecting structure 202 and the second connecting structure 203 can be replaced as needed, thereby achieving the technical effect of improving the convenience of use of the first connecting structure 202 and the second connecting structure 203.

[0088] Of course, in other embodiments, the detachable connection mode between the first connecting structure 202 and the shell 201, and the second connecting structure 203 and the shell 201 can be adjusted according to the design of the microneedle device.

[0089] In addition, the lengths of the first connecting structure 202 and the second connecting structure 203 are adjustable. Based on this, the lengths of the first connecting structure 202 and the second connecting structure 203 can be adjusted according to the size of the part to be pierced, thereby achieving the technical effect of improving the convenience of use of the microneedle device. As a convertible embodiment, only the length of the first connecting structure 202 or only the length of the second connecting structure 203 can be adjustable.

[0090] In this embodiment, the length of the first connecting structure 202 and the length of the second connecting structure 203 are adjusted by the buckle structure, and the buckle structure can be an adjustable buckle of a backpack shoulder strap. This structure is a mature technology and will not be described in detail here.

[0091] Of course, in other embodiments, the length adjustment method of the first connecting structure 202 and the second connecting structure 203 can be changed according to the design of the microneedle device. For example, the first connecting structure 202 and the second connecting structure 203 are knotted respectively, and the knot length of the first connecting structure 202 and the second connecting structure 203 is adjusted according to actual needs, thereby realizing the length adjustment of the first connecting structure 202 and the second connecting structure 203.

[0092] In addition, in this embodiment, the material of the shell 201 is flexible silicone. As a convertible embodiment, the material of the shell 201 can also be one of hard polyethylene, thermoplastic polymer material, ABS (Acrylonitrile-Butadiene-Styrene) engineering plastic, polypropylene, polyvinyl chloride, polyurethane, silicone material, polycarbonate, and resin, or a combination of multiple of them.

[0093] In other embodiments, according to the design of the microneedle device, only the first free end 2021 and the second free end 2031 can be detachably connected, or only the first connecting structure 202 and one end of the shell 201 can be detachably connected, or only the second connecting structure 203 and the other end of the shell 201 can be detachably connected, or only the first connecting structure 202 has elasticity, or only the second connecting structure 203 has elasticity, or only the length of the first connecting structure 202 is adjustable, or only the length of the second connecting structure 203 is adjustable, or only the material of the shell 201 is one or a combination of multiple of flexible silicone, thermoplastic polymer material, ABS engineering plastic, polypropylene, polyvinyl chloride, polyurethane, silicone material, polycarbonate, hard polyethylene, and resin, or only the microneedle unit 1 and the shell 201 are detachably connected.

[0094] In addition, as shown in Figure 1 , Figures 3 to 5 , in the present embodiment, the microneedle unit 1 comprises:

[0095] a base 102, the base 102 is entirely arranged in the second accommodating cavity and is connected with the shell 201, i.e. connected with the cover 2012, i.e. as shown in Figure 1 , at this time, the bottom surface of the base 102 and the bottom surface of the cover 2012 are located on the same horizontal line.

[0096] a plurality of spaced microneedle structures 101, each microneedle structure 101 is connected with the base 102, and the first accommodating cavity is arranged in the microneedle structure 101.

[0097] By arranging the base 102, the positions of the plurality of microneedle structures 101 can be fixed. Based on this, when the microneedle structure 101 is fixed with the wearing unit 2, the fixing between the base 102 and the wearing unit 2 can realize the fixing between the microneedle structure 101 and the wearing unit 2, so as to achieve the technical effect of improving the convenience of connection. As a convertible embodiment, the base 102 can also not be arranged.

[0098] Of course, in other embodiments, only one microneedle structure 101 can be arranged. Compared with other embodiments, the present embodiment arranges a plurality of microneedle structures 101. Based on this, the extraction amount of tissue fluid of the plurality of microneedle structures 101 is larger at the same time, so as to achieve the technical effect of improving the extraction speed.

[0099] As a convertible embodiment, part of the shell 201 can be arranged in the second accommodating cavity.

[0100] In addition, in the present embodiment, the material of the microneedle structure 101 is photocurable resin. As a convertible embodiment, the material of the shell 201 can be one of high polymer, plastic and inorganic material, or a combination of a plurality of materials between photocurable resin, high polymer, plastic and inorganic material.

[0101] Among them, the high polymer includes but is not limited to polydimethylsiloxane, polyvinyl alcohol, polyurethane, polyethylene glycol, photocurable resin, methacrylated gelatin, methacrylated hyaluronic acid and methacrylated polyethylene glycol. The inorganic material includes metal and inorganic non-metal. The photocurable resin can be a biocompatible photocurable resin, and the biocompatible photocurable resin can be prepared by reaction of methacrylate oligomer, methacrylate monomer, acrylic monomer and photoinitiator.

[0102] Of course, in other embodiments, the material of the microneedle structure 101 can be adjusted according to the design of the microneedle device.

[0103] In addition, in the embodiment, the base 102 and the microneedle structure 101 are integrally formed. Based on this, the base 102 and the microneedle structure 101 do not need to be additionally fixed, thereby achieving the technical effect of improving the convenience of processing the microneedle unit 1, and also achieving the technical effect of improving the connection stability between the base 102 and the microneedle structure 101. As a changeable implementation manner, the base 102 and the microneedle structure 101 can also be separately arranged and then fixed by being pasted.

[0104] In the embodiment, the base 102 and the microneedle structure 101 can be formed by 3D (three-dimensional) printing. Of course, in other embodiments, the processing manner of the microneedle unit 1 can be adjusted according to different designs of the microneedle device.

[0105] In addition, the inner wall thickness of the first accommodating cavity can be adjusted as needed. Meanwhile, the shape formed by the plurality of microneedle structures 101 can be one or a combination of multiple of a conical shape, a square conical shape, a pyramid shape, a multiple conical shape, a multiple square conical shape, and a multiple pyramid shape.

[0106] Further, in the embodiment, the shape formed by the plurality of microneedle structures 101 can be a rectangular shape. Of course, in other embodiments, the shape formed by the plurality of microneedle structures 101 can be one or a combination of multiple of a circular shape, an elliptical shape, and a polygonal shape, or the shape formed by the plurality of microneedle structures 101 can be adjusted according to different designs of the microneedle device.

[0107] In addition, in the embodiment, the plurality of microneedle structures 101 form a microneedle array of 2x2-20x20, for example, in the embodiment, the microneedle array can be 10x10, that is, the microneedle structure 101 is arranged at intervals of 10 in the horizontal direction and arranged at intervals of 10 in the vertical direction, and the area formed by the plurality of microneedle structures 101 is within the range of 0.2 cm 2 - 50 cm 2 , for example, in the embodiment, the area can be 4.41 cm 2 .

[0108] Further, the distance between adjacent microneedle structures 101 is within the range of 300 μm-3000 μm, for example, in the embodiment, the distance can be 2000 μm. The length of the microneedle structure 101 is within the range of 200 μm-2000 μm, for example, in the embodiment, the length can be 700 μm. The microneedle structure 101 with the length is insufficient to contact the nerve endings in the dermis, and causes little damage to human skin, thereby achieving the technical effect of reducing pain.

[0109] Of course, in other embodiments, the size and area of the microneedle array formed by the plurality of microneedle structures 101, the distance between adjacent microneedle structures 101, and the length of the microneedle structure 101 can all be adjusted according to the design of the microneedle device.

[0110] In addition, in combination with Figure 5 As shown in the drawings, in the present embodiment, the surface of the microneedle structure 101 is provided with two communication holes 103, and of course, in other embodiments, the number of communication holes 103 can be adjusted according to the design of the microneedle device, and the number of communication holes 103 can be one or more than two, all within the protection scope of the present application.

[0111] Among them, the inner diameter of the communication hole 103 is within the range of 10-1000 μm, for example, the inner diameter of the communication hole 103 in the present embodiment can be 250 μm. Of course, in other embodiments, the inner diameter of the communication hole 103 can be adjusted according to the design of the microneedle device.

[0112] In addition, in the present embodiment, the base 102 includes a third accommodating cavity, and the third accommodating cavity is in communication with the communication hole 103. Based on this, the space of the microneedle unit 1 for accommodating tissue fluid can be increased through the third accommodating cavity, so as to achieve the technical effect of improving the ability of the microneedle unit 1 to collect tissue fluid. As a convertible embodiment, the base 102 can also not include the third accommodating cavity.

[0113] In addition, one end of the base 102 is provided with a third pipeline 104 communicating with the third accommodating cavity.

[0114] Further, in combination with Figure 4 As shown in the drawings, in the present embodiment, the microneedle device includes:

[0115] The driving unit 3 is arranged in the second accommodating cavity, and the driving unit 3 includes a first pipeline 301 and a driving structure 302, the driving structure 302 is in communication with one end of the first pipeline 301, the other end of the first pipeline 301 is in communication with the third pipeline 104, so as to realize the communication of the first pipeline 301 and the first accommodating cavity, and the driving unit 3 is used for driving the tissue fluid inside the part to be punctured to flow into the microneedle unit 1.

[0116] The driving structure 302 can give the tissue fluid inside the part to be punctured to enter the first pipeline 301 with power, so that the tissue fluid quickly passes through the communication hole 103 and the first accommodating cavity into the third accommodating cavity and the third pipeline 104 in turn, thereby achieving the technical effect of improving the working efficiency of collecting the tissue fluid inside the part to be punctured.

[0117] The driving structure 302 is a peristaltic pump. As an alternative, the driving structure 302 can be one of a diaphragm pump, a peristaltic pump, a negative pressure pump, and a vacuum pump, or the type of the driving structure 302 can be adjusted according to the design of the microneedle device, which is not limited herein.

[0118] Preferably, the driving structure 302 is a micro pump, i.e., a pump that can be placed on the injection site and does not compress the injection site. For example, the micro pump has a size of 33mm x 18mm x 10mm and a weight of 6.5g.

[0119] Of course, in other embodiments, the size of the driving structure 302 can be adjusted according to the microneedle device.

[0120] In other embodiments, when the microneedle device injects a liquid into a human body or other organisms, the liquid can be driven into the first and third holding cavities by the driving unit 3, and then the microneedle device is inserted into the injection site, and the liquid is driven into the injection site by the driving unit 3, thereby completing the injection of the liquid.

[0121] As an alternative, one end of the base 102 can also not be provided with the third pipeline 104.

[0122] In addition, in combination with Figure 4 As shown in FIG. 1, the microneedle device includes:

[0123] The control unit 4 is in communication with the driving structure 302 and is used to control the opening and closing of the driving structure 302 and adjust the working mode of the driving structure 302.

[0124] In this embodiment, the control unit 4 includes a control circuit board and a control switch in communication. The control switch can be software built in the host computer. The control circuit board is arranged in the second holding cavity and is in communication with the driving structure 302. At this time, the control switch can be used separately from the control circuit board and remotely controls the opening and closing of the driving structure 302, thereby achieving the technical effect of improving the convenience of using the microneedle device.

[0125] Specifically, the communication connection in the embodiment can be a wireless connection, such as through a Bluetooth module and a WIFI module, to realize the opening and closing of the driving structure 302, and the working mode of the driving structure 302 can be set. The working mode can be to set the opening time, closing time, working time, pause time and cycle number of the driving structure 302. For example, for the cycle number, the driving structure 302 can work continuously for 10 minutes to complete the extraction of interstitial fluid, at which time the cycle number is 1, or the driving structure 302 can work continuously for 15 minutes, pause for 5 minutes, and then extract, with 10 cycles. The working mode is automatically controlled by the control unit 4, thereby improving the intelligent control of the driving structure 302.

[0126] The host computer can be a mobile phone or a computer, or other control structure. Meanwhile, the Bluetooth module and the WIFI module to realize the communication connection are mature technologies, which will not be described in detail here.

[0127] Specifically, the control circuit board includes a micro control unit (Microcontroller Unit; MCU) for controlling, processing control instructions of the host computer, and controlling the working of the driving structure 302.

[0128] Of course, in other embodiments, the working mode of the driving unit 3 can be adjusted according to the design of the microneedle device.

[0129] Further, the control circuit board includes an antenna unit arranged in the second accommodating cavity and arranged on one side of the control unit 4. The antenna unit is used for wireless communication signal transmission of the Bluetooth module and the WIFI module. For example, the antenna unit receives signals transmitted by the host computer through the wireless communication of the Bluetooth module and the WIFI module, and transmits the signals to the micro control unit, so that the micro control unit controls the driving structure 302 according to the signal information.

[0130] When the driving structure 302 is not working for more than 5 minutes, the Bluetooth module and the WIFI module enter a shutdown state or a sleep state. As a convertible embodiment, the non-working time of the driving structure 302 can also be adjusted according to the design of the microneedle device.

[0131] Further, the control circuit board includes a reset button 401 arranged in the second accommodating cavity and arranged on the micro control unit. The reset button 401 is electrically connected with the Bluetooth module and the WIFI module. The shell 201 is provided with a hole 205 corresponding to the position of the reset button 401, so as to press the reset button 401 through the hole 205, avoid the reset button 401 exposed to the surface and misoperation, and improve the reliability of the microneedle device.

[0132] The reset button 401 is driven by an external force to reset the Bluetooth module and the WIFI module, and the host computer connected with the microneedle device can be replaced, so that the technical effect of improving the convenience of using the microneedle device is achieved.

[0133] Specifically, the reset button 401 can be two, and the hole 205 is also two correspondingly. One reset button 401 corresponds to the reset of the Bluetooth module, and the other reset button 401 corresponds to the reset of the WIFI module.

[0134] In addition, preferably, the micro control unit can control the flow of the tissue fluid transmitted by the driving unit 3. Specifically, the pulse width modulation method can be used to adjust the flow of the tissue fluid. The pulse width modulation is a mature technology and will not be described in detail here.

[0135] In other embodiments, the control unit 4 can be arranged on the wearing unit 2. The control unit 4 includes a control circuit board and a control switch. The control circuit board is arranged in the second accommodating cavity and is in communication connection with the driving structure 302. One side of the shell 201 is provided with a hole communicating with the second accommodating cavity. One end of the control switch is located outside the hole of the second accommodating cavity, and the other end of the control switch is arranged in the second accommodating cavity and is electrically connected with the control circuit board. When the user drives the control switch to open, the control circuit board can control the driving structure 302 to open, and the driving structure 302 drives the tissue fluid to flow into the first accommodating cavity and the third accommodating cavity. When the user drives the control switch to close, the control circuit board can control the driving structure 302 to close. The technical effect of improving the convenience of controlling the driving structure 302 is also achieved.

[0136] Of course, in other embodiments, the communication connection can be realized only by the Bluetooth module or only by the WIFI module.

[0137] As a variable implementation, the microneedle device can not include the control unit 4. In this case, the opening and closing of the driving structure 302 can be realized according to the switch of the driving structure 302 itself, and the working time of the driving structure 302 can be manually controlled to realize the adjustment of the working mode of the driving structure 302.

[0138] In addition, in the embodiment, the driving unit 3 includes:

[0139] The second pipeline 303 is in communication with one end of the driving structure 302, and the other end of the second pipeline 303 is in communication with the outside;

[0140] The storage unit is in communication with the other end of the second pipeline 303 and is used for storing the tissue fluid in the part to be pierced.

[0141] By setting the storage unit, the capacity of the microneedle device can be further improved, thereby achieving the technical effect of improving the capacity of the tissue fluid or external liquid.

[0142] In this embodiment, the storage unit can be detachably arranged in the second accommodating cavity. As a convertible embodiment, the storage unit can also be arranged outside the second accommodating cavity.

[0143] When collecting tissue fluid from different people, the second pipeline 303 and the storage unit can be replaced as needed.

[0144] Of course, in other embodiments, the external liquid can also be stored in the storage unit, and the liquid in the storage unit can be input into the interior of the part to be pierced by the driving structure 302.

[0145] As a convertible embodiment, the driving unit 3 does not include the second pipeline 303 and the storage unit.

[0146] Of course, in other embodiments, the driving unit 3 can only include the second pipeline 303, or the microneedle device can only include the control unit 4, according to the design of the microneedle device.

[0147] In addition, in this embodiment, the microneedle device includes:

[0148] The detection unit includes a detection structure and a display structure 7, the detection structure is in communication with the storage unit, and is used to detect the biomarker of the tissue fluid in the part to be pierced, and the display structure 7 is in communication connection with the detection structure, and is used to display the detection result. As a convertible embodiment, the detection structure can only be in communication with the second pipeline 303, or can be in communication with the other end of the second pipeline 303 and the storage unit at the same time.

[0149] The detection unit can be a body fluid sensor, and the type and content of the biomarker can be detected. Of course, in other embodiments, the type of the detection unit can be adjusted according to the design of the microneedle device.

[0150] Of course, in other embodiments, the microneedle device can not include the detection unit, and the tissue fluid in the first accommodating cavity, the second accommodating cavity and the first pipeline 301 can be transmitted to the storage unit, so that the biomarker in the tissue fluid in the storage unit can be detected by other large detection structure of the external liquid. Compared with other embodiments, the biomarker can be directly understood by the microneedle device in this embodiment, without the need for other large equipment, thereby achieving the technical effect of improving the convenience of detecting the biomarker in the tissue fluid.

[0151] In addition, in this embodiment, the microneedle device includes:

[0152] The power supply unit 5 is electrically connected with the control unit 4 and the driving unit 3, that is, arranged on the micro control unit, for supplying power to the control unit 4 and the driving unit 3. Based on this, there is no need to connect external power supply, so that the microneedle device can be used in the environment without power supply such as outdoor, to achieve the technical effect of improving the convenience of microneedle device power supply. Wherein, the power supply unit 5 can be a 3.7V lithium ion battery.

[0153] Of course, in other embodiments, the power supply unit 5 can only supply power to the control unit 4 or only to the driving unit 3. As a convertible implementation, the type and voltage of the power supply unit 5 can also be adjusted according to the design of the microneedle device. It can also be that the power supply unit 5 is not set, and the control unit 4 and the driving unit 3 are directly powered by external power supply.

[0154] In this embodiment, the microneedle device comprises:

[0155] The charging unit comprises a charging port 6 and a charging structure. The charging port 6 is arranged on one side of the wearing unit 2. One end of the charging port 6 is in communication with the outside, for electrically connecting with the external power supply. The other end of the charging port 6 is electrically connected with one end of the charging structure. The charging structure is arranged in the second accommodating cavity. The other end of the charging structure is electrically connected with the power supply unit 5.

[0156] Specifically, the charging structure can be integrally arranged on the control circuit board. As a convertible implementation, the charging structure can also be arranged separately from the control circuit board.

[0157] The charging unit comprises an indicator light. The indicator light is arranged on the surface of the shell 201. The indicator light is electrically connected with the charging structure, for displaying the power of the power supply unit 5. At the same time, the indicator light can also be electrically connected with the control circuit board, for displaying the boot state, shutdown state and sleep state of the driving structure 302.

[0158] Specifically, the indicator light is a red light emitting diode. When the power supply unit 5 is in the charging state, the indicator light emits light. When the charging is completed, the indicator light is extinguished. When the driving structure 302 is in the boot state, the indicator light is lit for 3 seconds and then extinguished. When the driving structure 302 is in the shutdown state or the sleep state, the indicator light flashes 3 times and then extinguishes. When the flow of interstitial fluid driven by the driving structure 302 changes, the indicator light flashes once.

[0159] Of course, in other embodiments, the type of indicator light and the working state of indicator light can be adjusted according to the design of the microneedle device.

[0160] In other embodiments, the microneedle device does not include a charging unit, and the sustainable power supply of the power supply unit 5 to the control unit 4 and the driving unit 3 is realized by replacing the power supply unit 5. Compared with other embodiments, the power supply unit 5 in this embodiment does not need to be replaced, that is, the power supply unit 5 can be a rechargeable structure, thereby achieving the technical effect of saving the cost of using the microneedle device.

[0161] Specifically, the following is an application case of the microneedle device of the present embodiment:

[0162] Case one, skin model extraction test

[0163] The 1.2% agarose hydrogel simulates human skin, the microneedle device of the present embodiment is worn on the human skin model, and the microneedle structure 101 is pressed into the inside of the simulated human skin model. The opening of the driving structure 302 is controlled by the upper computer control unit 4 to drive the tissue fluid from the simulated human skin model into the storage unit through the first containing cavity, the first pipeline 301 and the third containing cavity. The extraction time is 1 minute, 3 minutes, 5 minutes and 10 minutes, respectively. Then the driving structure 302 is closed by the upper computer control to stop extraction, and the microneedle device is taken off. The extraction amount is the difference between the mass before and after the microneedle device.

[0164] As shown in Figure 6 The sampling amount of the microneedle device of the present embodiment can reach more than 0.65g (about 650μL) within 10 minutes of sampling time.

[0165] Case two, SD (Sprague-Dawley) rat live tissue fluid extraction

[0166] As shown in Figure 7 The SD rat (about 130g, male) is weighed and fixed, and the pentobarbital sodium normal saline solution is prepared at a dose of 1mL / kg and 3%. The pentobarbital sodium anesthetic is injected slowly along the abdominal cavity. After confirming the success of the anesthesia, the iodophor is used for disinfection. The depilatory agent is used to depilate the back of the rat, and the physiological saline is used to wipe clean. The microneedle device is worn on the back of the rat, and the microneedle structure 101 is pressed into the skin of the back of the rat. The pressing state is maintained for 1 minute, 3 minutes, 5 minutes, 10 minutes and 15 minutes, respectively, and the extraction amount of the tissue fluid is counted.

[0167] As shown in Figure 8 The sampling amount of the microneedle device of the present embodiment can reach more than 15μL within 15 minutes of sampling time.

[0168] Although the embodiments of the present application are described in conjunction with the drawings, various modifications and changes can be made by those skilled in the art without departing from the spirit and scope of the present application, and such modifications and changes fall within the scope defined by the appended claims.

Claims

1. A microneedle device, characterized by, The micro-needle device comprises: a micro-needle unit (1) comprising a first accommodating cavity, the micro-needle unit (1) being provided with a communication hole (103) in communication with the first accommodating cavity, the micro-needle unit (1) being used for penetrating into the inside of a to-be-penetrated site so as to make the communication hole (103) communicate with the inside of the to-be-penetrated site; a wearing unit (2) connected with the micro-needle unit (1), the wearing unit (2) being used for detachably connecting the micro-needle unit (1) to the to-be-penetrated site.

2. The microneedle device of claim 1, wherein, The wearing unit (2) comprises: a shell (201) provided with a second accommodating cavity, the second accommodating cavity being provided with the micro-needle unit (1) therein; a first connecting structure (202) having one end connected with one end of the shell (201) and the other end being a first free end (2021); a second connecting structure (203) having one end connected with the other end of the shell (201) and the other end being a second free end (2031), the second free end (2031) being connected with the first free end (2021) and being used for being fixed to the to-be-penetrated site.

3. The microneedle device of claim 2, wherein, The first free end (2021) and the second free end (2031) are detachably connected; and / or, one end of the first connecting structure (202) and one end of the shell (201) are detachably connected; and / or, the other end of the second connecting structure (203) and the other end of the shell (201) are detachably connected; and / or, the first connecting structure (202) and / or the second connecting structure (203) have elasticity; and / or, the length of the first connecting structure (202) and / or the second connecting structure (203) is adjustable; and / or, the micro-needle unit (1) and the shell (201) are detachably connected; and / or, the material of the shell (201) is one or a combination of flexible silica gel, thermoplastic polymer material, ABS engineering plastic, polypropylene, polyvinyl chloride, polyurethane, silicone material, polycarbonate, hard polyethylene and resin.

4. The microneedle device of claim 2, wherein, The micro-needle device comprises: a driving unit (3) arranged in the second accommodating cavity, the driving unit (3) comprising a first pipeline (301) and a driving structure (302), the driving structure (302) being in communication with one end of the first pipeline (301), the other end of the first pipeline (301) being in communication with the first accommodating cavity, the driving unit (3) being used for driving the liquid in the inside of the to-be-penetrated site to flow into the micro-needle unit (1).

5. The microneedle device of claim 4, wherein, The driving unit (3) comprises: a second pipeline (303), the driving structure (302) being in communication with one end of the second pipeline (303), the other end of the second pipeline (303) being in communication with the outside; and / or, the micro-needle device comprises: A control unit (4) in communication with the driving structure (302) for controlling the opening and closing of the driving structure (302) and adjusting the working mode of the driving structure (302).

6. The microneedle device of claim 5, wherein, The microneedle device comprises: A storage unit in communication with the other end of the second pipeline (303) for storing the liquid in the puncture site or storing the liquid from the outside.

7. The microneedle device of claim 6, wherein, The microneedle device comprises: A detection unit comprising a detection structure and a display structure (7), the detection structure being in communication with the other end of the second pipeline (303) and / or the storage unit for detecting the biomarker of the liquid in the puncture site, and the display structure (7) being in communication with the detection structure for displaying the detection result.

8. The microneedle device of claim 5, wherein, The microneedle device comprises: A power supply unit (5) electrically connected with the control unit (4) and / or the driving unit (3) for supplying power to the control unit (4) and / or the driving unit (3).

9. The microneedle device of any one of claims 2-8, wherein, The microneedle unit (1) comprises: A base (102) at least partially arranged in the second accommodating cavity and connected with the shell (201); A plurality of spaced microneedle structures (101), each of the microneedle structures (101) being connected with the base (102), and the microneedle structure (101) being provided with the first accommodating cavity.

10. The microneedle device of claim 9, wherein, The base (102) comprises a third accommodating cavity in communication with the communication hole (103).

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