Microneedle device

Abstract

The invention relates to the technical field of medical apparatus and 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 communicating with the first containing cavity is formed in the microneedle unit, and the microneedle unit is used for puncturing the interior of a to-be-punctured part so that the communicating hole can communicate with the interior of the to-be-punctured part; the wearing unit is connected with the micro-needle unit, and the wearing unit is used for enabling the micro-needle unit to be detachably arranged on a to-be-punctured part. According to the invention, the wearing unit is arranged and is detachably arranged on the surface of the to-be-punctured part, so that the micro-needle unit is fixed on the to-be-punctured part, and further, the micro-needle unit is stably communicated with the to-be-punctured part. Compared with the prior art that the microneedle array is fixed to the to-be-punctured part through medical adhesive tape, the wearing unit does not need to be pasted to the surface of the to-be-punctured part, fixation between the microneedle unit and the to-be-punctured part can also be achieved, the situation that the to-be-punctured part is endowed with the dragging feeling is avoided, and the puncturing efficiency is improved. Therefore, the technical effect of improving the use comfort of the microneedle unit is achieved.

Description

Technical Field

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

[0002] The skin is the largest organ in the human body and is mainly composed of the epidermis, dermis and subcutaneous tissue. The dermis contains abundant interstitial fluid (ISF). ISF is formed by blood filtering through the capillaries of the subcutaneous tissue. Its composition is similar to that of plasma and contains rich biomarkers that can reflect the functional status of the human body, the progression of the disease and the degree of inflammatory response. At the same time, compared with traditional venous or fingertip blood collection methods, ISF extraction has the advantages of minimally invasive, painless and low risk of infection. Therefore, ISF is regarded as a body fluid sample that is expected to replace blood for disease diagnosis, prognosis assessment and drug level monitoring.

[0003] The existing microneedle device includes: a microneedle array, including a base and a plurality of microneedles arranged at micron-level intervals, the plurality of microneedles are fixedly connected to the base, each microneedle is a hollow structure, and the microneedles are inserted into the human skin to perform sampling through the capillary action of the microneedle pores. Specifically, when the existing microneedle array is sampling, when the skin at the sampling location moves, it is easy to cause the microneedle array to fall off, affecting the sampling process. Therefore, it is necessary to fix the microneedle array on the skin of the person to be extracted by medical tape, but when the medical tape is torn off, it is easy to give the skin of the person to be extracted a pulling feeling, reducing the comfort of using the microneedle device. Summary of the invention

[0004] In view of this, the present invention provides a microneedle device to solve the problem that the existing microneedle device requires medical tape to fix the microneedle array on the skin of the extractor, and when the medical tape is torn off, the skin of the extractor feels pulled, which reduces the comfort of using the microneedle device.

[0005] The present invention provides a microneedle device, comprising:

[0006] A microneedle unit, wherein the microneedle unit comprises a first accommodating cavity, and the microneedle unit is provided with a connecting hole connected to the first accommodating cavity, and the microneedle unit is used to pierce the interior of a part to be pierced, so that the connecting hole is connected to the interior of the part to be pierced;

[0007] A wearing unit is connected to the microneedle unit, and the wearing unit is used to detach the microneedle unit from the part to be punctured.

[0008] Beneficial effect: By providing a wearing unit, the wearing unit can be detached from the surface of the part to be punctured, so that the microneedle unit is fixed to the part to be punctured, and further the microneedle unit is stably connected to the part to be punctured. Compared with the related art in which the microneedle array is fixed to the part to be punctured by medical tape, the wearing unit in the present invention does not need to be attached to the surface of the part to be punctured, and can also achieve the fixation between the microneedle unit and the part to be punctured, avoiding giving the part to be punctured a sense of pulling, thereby achieving the technical effect of improving the comfort of using the microneedle unit.

[0009] In an optional embodiment, the wearing unit includes:

[0010] A housing, wherein the housing is provided with a second accommodating cavity, and the microneedle unit is arranged in the second accommodating cavity;

[0011] a first connecting structure, wherein one end of the first connecting structure is connected to one end of the housing, and the other end of the first connecting structure is a first free end;

[0012] A second connecting structure, one end of which is connected to the other end of the shell, the other end of which is a second free end, which is connected to the first free end and is used to be fixed to the part to be pierced.

[0013] Beneficial effect: 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, so that the shell can be fixed on the part to be punctured, that is, the microneedle unit is fixed on the part to be punctured, thereby improving the stability of the microneedle structure in extracting tissue fluid from the part to be punctured.

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

[0015] And / or, the first connecting structure is detachably connected to one end of the housing;

[0016] and / or, the second connection structure is detachably connected to the other end of the housing;

[0017] And / or, the first connecting structure and / or the second connecting structure has elastic force;

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

[0019] And / or, the microneedle unit is detachably connected to the housing;

[0020] And / or, the shell is made of one or more combinations of flexible silicone, thermoplastic polymer materials, ABS engineering plastics, polypropylene, polyvinyl chloride, polyurethane, silicone resin materials, polycarbonate, hard polyethylene and resin.

[0021] Beneficial effect: By setting a detachable connection between the first free end and the second free end, the microneedle unit can be placed directly at the part to be punctured without adjusting the position of the microneedle unit multiple times, thereby achieving the technical effect of improving the convenience of detachable connection between the wearing unit and the part to be punctured.

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

[0023] By limiting the first connection structure and the second connection structure to have elastic force, the first connection structure and the second connection structure can be adapted to the sizes of different parts to be punctured, 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, the length of the first connecting structure and the second connecting structure can be adjusted according to the size of the part to be punctured, thereby achieving the technical effect of improving the convenience of using the microneedle device.

[0025] By detachably connecting the microneedle unit to the housing, when collecting tissue fluid from different people, only the microneedle unit needs to be replaced without replacing the entire microneedle device, thereby achieving the technical effect of reducing the use cost of the microneedle device.

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

[0027] A driving unit is disposed in the second accommodating chamber, and includes a first pipe and a driving structure. The driving structure is connected to one end of the first pipe, and the other end of the first pipe is connected to the first accommodating chamber. The driving unit is used to drive the liquid inside the part to be punctured to flow into the microneedle unit.

[0028] Beneficial effect: The driving structure can provide power for the tissue fluid inside the puncture site to enter the first pipe, so that the tissue fluid can quickly pass through the connecting hole and the first accommodating chamber into the third accommodating chamber and the first pipe, thereby achieving the technical effect of improving the work efficiency of collecting tissue fluid inside the puncture site.

[0029] In an optional implementation, the driving unit includes:

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

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

[0032] A control unit is communicatively connected with the drive structure and is used to control the opening and closing of the drive structure and adjust the working mode of the drive structure.

[0033] Beneficial effect: By providing the second pipeline, the second pipeline can be connected to 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 ease of use of the microneedle device.

[0034] The working mode is automatically controlled by the control unit, thereby improving the intelligence of the drive structure control.

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

[0036] A storage unit is communicated with the other end of the second pipe and is used to store liquid in the area to be punctured or store external liquid.

[0037] Beneficial effect: By providing a storage unit, the holding capacity of the microneedle device can be further increased, thereby achieving the technical effect of increasing the capacity for tissue fluid or external liquid.

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

[0039] The detection unit includes a detection structure and a display structure. The detection structure is connected to the other end of the second pipe and / or the storage unit and is used to detect biomarkers in the liquid in the area to be punctured. The display structure is communicatively connected to the detection structure and is used to display the detection results.

[0040] Beneficial effect: By setting up a detection unit, the biomarkers in the tissue fluid can be detected without other large equipment, thereby achieving the technical effect of improving the simplicity of biomarker detection in the tissue fluid.

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

[0042] A power supply unit is electrically connected to the control unit and / or the drive unit, and is used to supply power to the control unit and / or the drive unit.

[0043] Beneficial effect: There is no need to connect to an external power supply, so that the microneedle device can be used in an environment without a power supply, such as outdoors, to achieve the technical effect of improving the convenience of power supply for the microneedle device.

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

[0045] A base, at least a portion of which is disposed in the second accommodating cavity and connected to the shell;

[0046] A plurality of microneedle structures are arranged at intervals, each of the microneedle structures is connected to the base, and the first accommodating cavity is arranged in the microneedle structure.

[0047] Beneficial effect: By setting a base, the positions of multiple microneedle structures can be fixed. Based on this, when the microneedle structure is fixed to the wearing unit, the fixation between the microneedle structure and the wearing unit can be achieved by fixing the base to the wearing unit, thereby achieving the technical effect of improving the simplicity of connection. By setting multiple microneedle structures, compared with setting only one microneedle structure, multiple microneedle structures can extract a larger amount of tissue fluid at the same time, thereby achieving the technical effect of improving the extraction speed.

[0048] In an optional embodiment, the base includes a third accommodating cavity, and the third accommodating cavity is communicated with the communicating hole.

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

[0050] In order to more clearly illustrate the specific implementation methods of the present invention or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0051] Figure 1 is a front view of the microneedle device of this embodiment;

[0052] Figure 2 is a schematic structural diagram of the microneedle device of this embodiment;

[0053] Figure 3 The structure diagram of the microneedle unit, the driving unit, the control unit, the power supply unit and the charging port in the microneedle device of this embodiment is shown in FIG. Figure 1 ;

[0054] Figure 4The structure diagram of the microneedle unit, the driving unit, the control unit, the power supply unit and the charging port in the microneedle device of this embodiment is shown in FIG. Figure 2 ;

[0055] Figure 5 is a schematic structural diagram of a microneedle unit in the microneedle device of this embodiment;

[0056] Figure 6 The results of the extraction test of the microneedle device of this embodiment in a 1.2% agarose gel skin model;

[0057] Figure 7 Schematic diagram of the microneedle device of this embodiment worn on SD (Sprague-Dawley) rats;

[0058] Figure 8 The figure shows the results of the extraction test of the microneedle device of this example on SD rats.

[0059] Description of reference numerals:

[0060] 1. Microneedle unit; 101. Microneedle structure; 102. Base; 103. Communication hole; 104. Third pipeline;

[0061] 2. wearing unit; 201. housing; 2011. body; 2012. cover;

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

[0063] 203, second connection 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 solution and advantages of the embodiments of the present invention clearer, the technical solution in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative work are within the scope of protection of the present invention.

[0068] Combine the following Figures 1 to 8 , describing an embodiment of the present invention.

[0069] According to an embodiment of the present invention, there is provided a microneedle device, comprising:

[0070] The microneedle unit 1 includes a first accommodating cavity, and a connecting hole 103 communicating with the first accommodating cavity is provided on the microneedle unit 1. The microneedle unit 1 is used to pierce the interior of the part to be pierced, so that the connecting hole 103 is connected with the interior of the part to be pierced;

[0071] The wearing unit 2 is connected to the microneedle unit 1 and is used to detach the microneedle unit 1 from the part to be punctured.

[0072] In the microneedle device of this embodiment, by providing a wearing unit 2, the wearing unit 2 can be detached from the surface of the part to be punctured, so that the microneedle unit 1 is fixed to the part to be punctured, and further the microneedle unit 1 is stably connected to the part to be punctured. Compared with the related art in which the microneedle array is fixed to the part to be punctured by medical tape, the wearing unit 2 in this embodiment does not need to be attached to the surface of the part to be punctured, and can also achieve the fixation between the microneedle unit 1 and the part to be punctured, avoiding giving the part to be punctured a sense of pulling, thereby achieving the technical effect of improving the comfort of using the microneedle unit 1.

[0073] In this embodiment, the microneedle unit 1 can be used to extract tissue fluid under the epidermis of the human body and other organisms. Of course, in other embodiments, the microneedle unit 1 can be used to extract tissue fluid of different organisms, or inject liquid into the human body and other organisms, all within the scope of protection of the present invention.

[0074] In addition, combined Figure 1 and Figure 2 As shown, in this embodiment, the wearing unit 2 includes:

[0075] The housing 201 is provided with a second accommodating cavity, and the microneedle unit 1 is arranged in the second accommodating cavity;

[0076] A first connection structure 202, one end of the first connection structure 202 is connected to one end of the housing 201, and the other end of the first connection structure 202 is a first free end 2021;

[0077] The second connection structure 203 has one end connected to the other end of the housing 201 , and the other end of the second connection structure 203 is a second free end 2031 , which is connected to the first free end 2021 and is used to be fixed to the part to be pierced.

[0078] By setting the first connecting structure 202 and the second connecting structure 203, the first free end 2021 of the first connecting structure 202 and the second free end 2031 of the second connecting structure 203 are connected, so that the shell 201 can be fixed on the part to be punctured, that is, the microneedle unit 1 is fixed on the part to be punctured, thereby improving the stability of the microneedle unit 1 in extracting tissue fluid from the part to be punctured.

[0079] The housing 201 includes a body 2011 and a cover 2012, the body 2011 includes a second accommodating cavity, and the cover 2012 is detachably connected to the body 2011. Specifically, the cover 2012 is detachably connected to the body 2011 by a buckle, and the buckle 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, according to different designs of the microneedle device, the detachable manner between the cover 2012 and the body 2011 can be adjusted.

[0080] Furthermore, the microneedle unit 1 is detachably connected to the housing 201. Based on this, when collecting tissue fluid from 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 collecting tissue fluid from the same person's puncture site, when the microneedle unit 1 is worn out too much, only the microneedle unit 1 can be replaced. As a convertible embodiment, the microneedle unit 1 can also be fixedly connected to the housing 201.

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

[0083] Preferably, the first connection structure 202 and the second connection structure 203 have elastic force, so that the first connection structure 202 and the second connection structure 203 can be adapted to the size of different parts to be punctured, thereby achieving the technical effect of improving the adaptability of the microneedle device. As a convertible embodiment, it is also possible that the first connection structure 202 or the second connection structure 203 has elastic force, or the first connection structure 202 and the second connection structure 203 do not have elastic force.

[0084] Furthermore, in the present 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, and in this case, the wearing unit 2 needs to be sleeved on the part to be punctured, 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 punctured. Compared with other embodiments, in the present embodiment, the microneedle unit 1 can be directly placed at the part to be punctured, and the wearing unit 2 can be detachably connected to the part to be punctured without adjusting the position of the wearing unit 2 multiple times, thereby achieving the technical effect of improving the convenience of detachable connection between the wearing unit 2 and the part to be punctured.

[0085] The first free end 2021 and the second free end 2031 can be detachably connected by a male and female buckle. Specifically, the first free end 2021 is provided with a plurality of male buckles, and the second free end 2031 is provided with a female buckle. A male buckle is selected according to the size of the part to be pierced to be buckled and connected with the female buckle. As a convertible embodiment, the first free end 2021 can be provided with a male buckle, and the second free end 2031 can be provided with a plurality of female buckles.

[0086] Of course, in other embodiments, the detachable connection 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 tied to the site to be punctured by external force to achieve the fixation of the microneedle unit 1 on the site to be punctured.

[0087] In addition, in this embodiment, the first connection structure 202 is detachably connected to one end of the housing 201, and the second connection structure 203 is detachably connected to the other end of the housing 201. A connecting hole 103 is provided between the first connection structure 202 and the housing 201, and between the second connection structure 203 and the housing 201. By passing the spring rod through the connecting hole 103, the detachable connection between the first connection structure 202 and the housing 201, and between the second connection structure and the housing 201 can be achieved. Based on this, the first connection structure 202 and the second connection structure 203 can be replaced as needed, thereby achieving the technical effect of improving the convenience of using the first connection structure 202 and the second connection structure 203.

[0088] Of course, in other embodiments, the detachable connection between the first connection structure 202 and the housing 201 and between the second connection structure 203 and the housing 201 may be adjusted according to different designs of the microneedle device.

[0089] In addition, the lengths of the first connection structure 202 and the second connection structure 203 are adjustable. Based on this, the lengths of the first connection structure 202 and the second connection 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 using the microneedle device. As a convertible embodiment, it is also possible that only the length of the first connection structure 202 or only the second connection structure 203 is adjustable.

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

[0091] Of course, in other embodiments, the length of the first connection structure 202 and the length adjustment method of the second connection structure 203 can be changed according to the different designs of the microneedle device. For example, the first connection structure 202 and the second connection structure 203 are respectively knotted, and the knotting lengths of the first connection structure 202 and the second connection structure 203 are respectively adjusted according to actual needs, thereby achieving the adjustment of the lengths of the first connection structure 202 and the second connection structure 203.

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

[0093] In other embodiments, depending on the design of the microneedle device, only the first free end 2021 and the second free end 2031 may be detachably connected, or only the first connection structure 202 and one end of the shell 201 may be detachably connected, or only the second connection structure 203 and the other end of the shell 201 may be detachably connected, or only the first connection structure 202 may have elasticity, or only the second connection structure 203 may have elasticity, or only the length of the first connection structure 202 may be adjustable, or only the length of the second connection structure 203 may be adjustable, or only the material of the shell 201 may be a combination of one or more of flexible silicone, thermoplastic polymer material, ABS engineering plastic, polypropylene, polyvinyl chloride, polyurethane, silicone resin material, polycarbonate, hard polyethylene and resin, or only the microneedle unit 1 and the shell 201 may be detachably connected.

[0094] In addition, combined Figure 1 , Figures 3 to 5 As shown, in this embodiment, the microneedle unit 1 includes:

[0095] The base 102 is completely disposed in the second accommodating cavity and is connected to the housing 201, that is, connected to the cover 2012, that is, combined with Figure 1 As shown, 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 microneedle structures 101 are arranged at intervals, each of the microneedle structures 101 is connected to a base 102 , and a first accommodating cavity is provided in the microneedle structure 101 .

[0097] By setting 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 to the wearing unit 2, the fixing between the base 102 and the wearing unit 2 can achieve the fixing between the microneedle structure 101 and the wearing unit 2, thereby achieving the technical effect of improving the simplicity of connection. As a convertible embodiment, the base 102 may also be not set.

[0098] Of course, in other embodiments, only one microneedle structure 101 may be provided. Compared with other embodiments, this embodiment provides multiple microneedle structures 101. Based on this, multiple microneedle structures 101 can extract a larger amount of tissue fluid at the same time, thereby achieving the technical effect of increasing the extraction speed.

[0099] As a convertible implementation, part of the shell 201 may be disposed in the second accommodating cavity.

[0100] In addition, in this embodiment, the material of the microneedle structure 101 is a photocurable resin. As a changeable implementation, the material of the housing 201 can also be one of polymers, plastics and inorganic materials, or a combination of multiple materials among photocurable resins, polymers, plastics and inorganic materials.

[0101] Among them, the high molecular polymer includes but is not limited to polydimethylsiloxane, polyvinyl alcohol, polyurethane, polyethylene glycol, light-curable resin, methacrylated gelatin, methacrylated hyaluronic acid and methacrylated polyethylene glycol. Inorganic materials include metals and inorganic non-metals. The light-curable resin can be a biocompatible light-curable resin, and the biocompatible light-curable resin can be prepared by reacting methacrylate oligomers, methacrylate monomers, acrylic monomers and photoinitiators.

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

[0103] In addition, in this embodiment, the base 102 and the microneedle structure 101 are integrally formed. Based on this, there is no need to additionally fix the base 102 and the microneedle structure 101, thereby achieving the technical effect of improving the simplicity of processing the microneedle unit 1, and at the same time, it can also achieve the technical effect of improving the connection stability between the base 102 and the microneedle structure 101. As a convertible implementation method, the base 102 and the microneedle structure 101 can also be separately set and then glued and fixed.

[0104] The base 102 and the microneedle structure 101 can be formed by 3D (three-dimensional) printing. Of course, in other embodiments, the processing method of the microneedle unit 1 is adjusted according to the 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 cone, square cone, pyramid, multiple cones, multiple square cones and multiple pyramids.

[0106] Furthermore, in this embodiment, the shape formed by the multiple microneedle structures 101 can be a rectangle. Of course, in other embodiments, the shape formed by the multiple microneedle structures 101 can be one of a circle, an ellipse, and a polygon, or a combination of multiple shapes of rectangle, circle, ellipse, and polygon, or the shape formed by the multiple microneedle structures 101 can be adjusted according to the design of the microneedle device.

[0107] In addition, in this embodiment, a plurality of microneedle structures 101 form a 2×2 to 20×20 microneedle array, for example, in this embodiment, a 10×10 microneedle array may be formed, that is, 10 microneedle structures 101 are arranged at intervals in the horizontal direction and 10 microneedle structures are arranged at intervals in the vertical direction, and the area formed by the plurality of microneedle structures 101 is located at 0.2 cm 2 ~50cm 2 In the range of, for example, in this embodiment, it can be 4.41cm 2 .

[0108] Furthermore, the distance between adjacent microneedle structures 101 is between 300 μm and 3000 μm, for example, 2000 μm in this embodiment. The length of the microneedle structure 101 is between 200 μm and 2000 μm, for example, 700 μm in this embodiment. The microneedle structure 101 at this length is not sufficient to contact the nerve endings in the dermis, causing little trauma 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 multiple microneedle structures 101, the distance between adjacent microneedle structures 101, and the length of the microneedle structure 101 can be adjusted according to the different designs of the microneedle device.

[0110] In addition, combined Figure 5 As shown, in this embodiment, two connecting holes 103 are provided on the surface of the microneedle structure 101. Of course, in other embodiments, the number of connecting holes 103 can be adjusted according to the design of the microneedle device. The number of connecting holes 103 can be one or more than two, all within the protection scope of the present invention.

[0111] The inner diameter of the connecting hole 103 is in the range of 10 μm to 1000 μm. For example, in this embodiment, the inner diameter of the connecting hole 103 may be 250 μm. Of course, in other embodiments, the inner diameter of the connecting hole 103 may be adjusted according to different designs of the microneedle device.

[0112] In addition, in this embodiment, the base 102 includes a third accommodating cavity, and the third accommodating cavity is connected to the connecting hole 103. Based on this, the third accommodating cavity can increase the space for the microneedle unit 1 to accommodate tissue fluid, thereby achieving the technical effect of improving the ability of the microneedle unit 1 to collect tissue fluid. As a convertible embodiment, the base 102 may also not include the third accommodating cavity.

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

[0114] Furthermore, combined with Figure 4 As shown, in this embodiment, the microneedle device includes:

[0115] The driving unit 3 is arranged in the second accommodating chamber. The driving unit 3 includes a first pipe 301 and a driving structure 302. The driving structure 302 is connected to one end of the first pipe 301, and the other end of the first pipe 301 is connected to the third pipe 104, thereby realizing the connection between the first pipe 301 and the first accommodating chamber. The driving unit 3 is used to drive the tissue fluid inside the part to be punctured to flow into the microneedle unit 1.

[0116] The driving structure 302 can provide power for the tissue fluid inside the puncture site to enter the first pipe 301, so that the tissue fluid can quickly pass through the connecting hole 103 and the first accommodating chamber into the third accommodating chamber and the third pipe 104 in turn, thereby achieving the technical effect of improving the work efficiency of collecting tissue fluid inside the puncture site.

[0117] The driving structure 302 is a peristaltic pump. As a convertible embodiment, the driving structure 302 may 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 may be adjusted according to the design of the microneedle device, without making too many restrictions here.

[0118] Preferably, the driving structure 302 is a micro pump, that is, a pump that can be placed on the part to be punctured and does not press the part to be punctured. For example, the size of the micro pump is 33mm×18mm×10mm and the weight is 6.5g.

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

[0120] In other embodiments, when the microneedle device injects liquid into the human body or other organisms, the liquid can be driven into the first accommodating chamber and the third accommodating chamber by the driving unit 3, and then the microneedle device is inserted into the part to be punctured, and the liquid is driven by the driving unit 3 to flow into the interior of the part to be punctured, thereby completing the injection of the liquid.

[0121] As a convertible embodiment, the third pipe 104 may not be provided at one end of the base 102 .

[0122] In addition, combined Figure 4 As shown, in this embodiment, 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 that are communicatively connected. The control switch can be software built into the host computer. The control circuit board is arranged in the second accommodating cavity and is communicatively connected to the drive structure 302. At this time, the control switch can be used separately from the control circuit board and remotely control the opening and closing of the drive structure 302, thereby achieving the technical effect of improving the convenience of using the microneedle device.

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

[0126] The host computer can be a mobile phone or a computer, or other control structures. At the same time, the Bluetooth module and the WIFI module are mature technologies for communication connection, which will not be described in detail here.

[0127] Specifically, the control circuit board includes a microcontroller unit (MCU), which is responsible for controlling and processing control instructions of the host computer, controlling the work of the driving structure 302, and the like.

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

[0129] Furthermore, the control circuit board includes an antenna unit, which is arranged in the second accommodating cavity and 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 the signal transmitted by the host computer through the wireless communication of the Bluetooth module and the WIFI module, and transmits the signal to the microcontroller unit, so that the microcontroller 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 implementation, the non-working time of the driving structure 302 can also be adjusted according to the design of the microneedle device.

[0131] Furthermore, the control circuit board includes a reset button 401, which is arranged in the second accommodating cavity and on the micro control unit. The reset button 401 is electrically connected to the Bluetooth module and the WIFI module. The shell 201 is provided with a hole 205 at the position corresponding to the reset button 401, so as to facilitate pressing the reset button 401 through the hole 205, thereby avoiding the reset button 401 being exposed to the surface and accidentally touched, thereby achieving the technical effect of improving the reliability of the use of the microneedle device.

[0132] Among them, by driving the reset button 401 with external force, the Bluetooth module and the WIFI module can be reset, and the host computer connected to the microneedle device can be replaced, thereby achieving the technical effect of improving the convenience of using the microneedle device.

[0133] Specifically, there may be two reset buttons 401 , that is, there are two holes 205 , one reset button 401 corresponds to resetting the Bluetooth module, and the other reset button 401 corresponds to resetting the WIFI module.

[0134] In addition, preferably, the micro control unit can control the flow rate of tissue fluid transmitted by the driving unit 3. Specifically, pulse width modulation can be used to adjust the flow rate of tissue fluid. 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, and the control unit 4 includes a control circuit board and a control switch. The control circuit board is arranged in the second accommodating chamber and is communicatively connected to the driving structure 302. One side of the housing 201 is provided with a hole connected to the second accommodating chamber, one end of the control switch is located outside the hole of the second accommodating chamber, and the other end of the control switch is arranged in the second accommodating chamber and is electrically connected to the control circuit board. Among them, when the user drives the control switch to turn on, the control circuit board can control the driving structure 302 to turn on, and the driving structure 302 drives the tissue fluid to flow into the first accommodating chamber and the third accommodating chamber. When the user drives the control switch to turn off, the control circuit board can control the driving structure 302 to turn off. The technical effect of improving the simplicity of control of the driving structure 302 can also be achieved.

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

[0137] As a convertible implementation, the microneedle device may not include the control unit 4. In this case, the driving structure 302 can be turned on and off according to the switch of the driving structure 302 itself, and the working time of the driving structure 302 can be manually controlled to adjust the working mode of the driving structure 302.

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

[0139] A second pipe 303, the driving structure 302 is connected to one end of the second pipe 303, and the other end of the second pipe 303 is connected to the outside;

[0140] The storage unit is connected to the other end of the second pipe 303 and is used to store tissue fluid in the area to be punctured.

[0141] By providing a storage unit, the holding capacity of the microneedle device can be further increased, thereby achieving the technical effect of increasing the capacity for tissue fluid or external liquid.

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

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

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

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

[0146] Of course, in other embodiments, depending on the design of the microneedle device, only the driving unit 3 may include the second pipe 303 , or only the microneedle device may include the control unit 4 .

[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 connected to the storage unit and is used to detect biomarkers in the tissue fluid of the site to be punctured. The display structure 7 is connected to the detection structure and is used to display the detection results. As a convertible embodiment, the detection structure can also be connected only to the second pipe 303, or to the other end of the second pipe 303 and the storage unit at the same time.

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

[0150] Of course, in other embodiments, the microneedle device may not include a detection unit, and the tissue fluid in the first accommodating cavity, the second accommodating cavity and the first pipe 301 are all transferred to the storage unit, so that the tissue fluid in the storage unit is passed through other large detection structures in the outside to detect the biomarkers in the tissue fluid. Compared with other embodiments, this embodiment can directly understand the situation of biomarkers through the microneedle device without other large equipment, thereby achieving the technical effect of improving the simplicity of biomarker detection in tissue fluid.

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

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

[0153] Of course, in other embodiments, the power supply unit 5 may only supply power to the control unit 4, or only to the drive unit 3. As a convertible implementation, the type and voltage of the power supply unit 5 may be adjusted according to the design of the microneedle device. Alternatively, the power supply unit 5 may not be provided, and the control unit 4 and the drive unit 3 may be supplied with power directly from an external power source.

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

[0155] The charging unit includes 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 connected to the outside world and is used to be electrically connected to an external power supply. The other end of the charging port 6 is electrically connected to one end of the charging structure. The charging structure is arranged in the second accommodating cavity, and the other end of the charging structure is electrically connected to 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 and the control circuit board can also be arranged separately.

[0157] The charging unit includes an indicator light, which is arranged on the surface of the housing 201 and is electrically connected to the charging structure to display the power level of the power supply unit 5. At the same time, the indicator light can also be electrically connected to the control circuit board to display the power-on state, power-off 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 is on, and when the charging is completed, the indicator light is off. When the driving structure 302 is in the power-on state, the indicator light is on for 3 seconds and then goes out. When the driving structure 302 is in the power-off state or the sleep state, the indicator light flashes 3 times and then goes out. When the driving structure 302 drives the flow rate of the tissue fluid to change, the indicator light flashes once.

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

[0160] In other embodiments, the microneedle device does not include a charging unit, and by replacing the power supply unit 5, the power supply unit 5 can continuously supply power to the control unit 4 and the driving unit 3. Compared with other embodiments, in this embodiment, there is no need to replace the power supply unit 5, 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 are application examples of the microneedle device of this embodiment:

[0162] Case 1: Skin model extraction test

[0163] 1.2% agarose hydrogel was used to simulate human skin, and the microneedle device of this embodiment was worn on the human skin model, and the microneedle structure 101 was pressed into the interior of the simulated human skin model. The upper computer control unit 4 controlled the opening of the driving structure 302 to drive the tissue fluid from the simulated human skin model through the first accommodating chamber, the first pipeline 301 and the third accommodating chamber into the storage unit. The extraction times were 1 minute, 3 minutes, 5 minutes and 10 minutes respectively, and then the upper computer controlled the closing of the driving structure 302 to stop the extraction and remove the microneedle device. The extraction amount was the mass difference before and after the microneedle device.

[0164] Combination Figure 6 As shown, within a sampling time of 10 minutes, the sampling volume of the microneedle device of the present invention can reach more than 0.65 g (about 650 μL).

[0165] Case 2: Extraction of living tissue fluid from SD (Sprague-Dawley) rats

[0166] Combination Figure 7 As shown, SD rats (about 130g, male) were weighed and fixed, and sodium pentobarbital saline solution was prepared at a dose of 1mL / kg and 3%, and sodium pentobarbital anesthetic was slowly injected along the peritoneal cavity. After confirming that the anesthesia was successful, disinfect with iodine tincture. Depilatory agents were used to remove hair on the back of the rat and wiped clean with saline. The microneedle device was worn on the back of the rat, and the microneedle structure 101 was pressed into the skin on the back of the rat, and the pressing state was maintained for 1 minute, 3 minutes, 5 minutes, 10 minutes, and 15 minutes, respectively, and the amount of tissue fluid extracted was counted.

[0167] Combination Figure 8 As shown, within a sampling time of 15 minutes, the sampling volume of the microneedle device of the present invention can reach more than 15 μL.

[0168] Although the embodiments of the present invention have been described in conjunction with the accompanying drawings, those skilled in the art may make various modifications and variations without departing from the spirit and scope of the present invention, and such modifications and variations are all within the scope defined by the appended claims.

Claims

1. A microneedle device, characterized in that: include: A microneedle unit (1), the microneedle unit (1) comprising a first accommodating cavity, the microneedle unit (1) being provided with a connecting hole (103) communicating with the first accommodating cavity, the microneedle unit (1) being used to pierce the interior of a part to be pierced, so that the connecting hole (103) is communicated with the interior of the part to be pierced; A wearing unit (2) is connected to the microneedle unit (1), and the wearing unit (2) is used to detach the microneedle unit (1) from the part to be punctured.

2. The microneedle device according to claim 1, characterized in that The wearing unit (2) comprises: A housing (201), wherein the housing (201) is provided with a second accommodating cavity, and the microneedle unit (1) is arranged in the second accommodating cavity; A first connection structure (202), one end of the first connection structure (202) being connected to one end of the housing (201), and the other end of the first connection structure (202) being a first free end (2021); A second connecting structure (203), one end of the second connecting structure (203) is connected to the other end of the shell (201), the other end of the second connecting structure (203) is a second free end (2031), the second free end (2031) is connected to the first free end (2021), and is used to be fixed to the part to be pierced.

3. The microneedle device according to claim 2, characterized in that The first free end (2021) and the second free end (2031) are detachably connected; And / or, the first connection structure (202) is detachably connected to one end of the housing (201); And / or, the second connection structure (203) is detachably connected to the other end of the housing (201); and / or, the first connection structure (202) and / or the second connection structure (203) have elastic force; And / or, the length of the first connecting structure (202) and / or the second connecting structure (203) is adjustable; And / or, the microneedle unit (1) is detachably connected to the housing (201); And / or, the material of the shell (201) is a combination of one or more of flexible silicone, thermoplastic polymer material, ABS engineering plastic, polypropylene, polyvinyl chloride, polyurethane, silicone resin material, polycarbonate, hard polyethylene and resin.

4. The microneedle device according to claim 2, characterized in that The microneedle device comprises: A drive unit (3) is arranged in the second accommodating chamber, the drive unit (3) comprising a first pipe (301) and a drive structure (302), the drive structure (302) being connected to one end of the first pipe (301), and the other end of the first pipe (301) being connected to the first accommodating chamber, the drive unit (3) being used to drive the liquid inside the part to be punctured to flow into the microneedle unit (1).

5. The microneedle device according to claim 4, characterized in that The driving unit (3) comprises: A second pipeline (303), wherein the driving structure (302) is in communication with one end of the second pipeline (303), and the other end of the second pipeline (303) is in communication with the outside; And / or, the microneedle device comprises: A control unit (4), the control unit (4) is communicatively connected to the drive structure (302), and is used to control the opening and closing of the drive structure (302), and to adjust the working mode of the drive structure (302).

6. The microneedle device according to claim 5, characterized in that The microneedle device comprises: A storage unit is connected to the other end of the second pipe (303) and is used to store liquid in the area to be punctured, or to store external liquid.

7. The microneedle device according to claim 6, characterized in that The microneedle device comprises: The detection unit comprises a detection structure and a display structure (7), wherein the detection structure is connected to the other end of the second pipe (303) and / or the storage unit and is used to detect the biomarkers in the liquid in the part to be punctured, and the display structure (7) is communicatively connected to the detection structure and is used to display the detection result.

8. The microneedle device according to claim 5, characterized in that The microneedle device comprises: A power supply unit (5) is electrically connected to the control unit (4) and / or the drive unit (3) and is used to supply power to the control unit (4) and / or the drive unit (3).

9. The microneedle device according to any one of claims 2 to 8, characterized in that: The microneedle unit (1) comprises: A base (102), at least a portion of the base (102) is disposed in the second accommodating cavity and connected to the housing (201); A plurality of microneedle structures (101) are arranged at intervals, each of the microneedle structures (101) is connected to the base (102), and the first accommodating cavity is provided in the microneedle structure (101).

10. The microneedle device according to claim 9, characterized in that The base (102) comprises a third accommodating cavity, and the third accommodating cavity is communicated with the communicating hole (103).

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