Blood collector microneedle and device

By optimizing the geometric structure and fixing method of microneedle, the problem of insufficient bleeding and shedding of the microneedle blood collector is solved, and efficient and safe blood collection effect is achieved, which is suitable for peripheral blood collection devices.

CN120458575APending Publication Date: 2025-08-12CHONGQING JUCE LIFE & HEALTH TECHNOLOGY CO LTD
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Patent Information

Application Number
CN202510791059.5
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-06-13
Publication Date
2025-08-12

AI Technical Summary

Technical Problem

The existing microneedle blood collectors have problems such as insufficient bleeding, microneedle shedding and obvious pain during use, especially among the elderly and children, and the prior art is difficult to maintain connection strength during transportation and long-term placement.

Method used

By optimizing the geometric structural parameters of the microneedle, sheet metal needles with a width of 0.5mm and above, thickness of 0.12mm and above, and height of 2.1mm and above, the number is greater than or equal to 15, the material hardness reaches HV370 or above, and it is fixed with the microneedle seat module through various methods, including hot melting, ultrasonic welding, screw connection, injection molding, snapping and inverting, etc., to ensure the connection is stable.

Benefits of technology

Efficient blood collection is achieved, ensuring that the microneedle does not fall off under a large axial force, avoiding the microneedle staying on the skin, improving the efficiency and safety of blood collection, and reducing pain.

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Abstract

The invention provides a blood collector microneedle and a device, and aims to improve the blood collection efficiency and ensure the use safety. A metal plate needle in the blood collector microneedle structure is perpendicular to the base; the width of the metal plate pins is at least 0.5 mm, the thickness of the metal plate pins is at least 0.12 mm, the height of the metal plate pins is at least 2.1 mm, the number of the metal plate pins is at least 15, and the material hardness of the metal plate pins reaches HV370 or above, so that the puncturing The base can be annular or circular and is firmly connected with the microneedle base module in various fixing modes, and the blood collector microneedle device which is reliable in structure, capable of bearing large axial force and high in blood collection efficiency is formed. According to the structural design, the microneedle of the blood collector can efficiently penetrate through the skin during blood collection, a micro channel is formed, sufficient blood collection amount is ensured, meanwhile, the microneedle is tightly connected with the base, large axial force can be borne, the microneedle is prevented from falling off or remaining on the skin in the using process, medical risks are effectively reduced, and blood collection efficiency and safety are improved.
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Description

Technical Field

[0001] The present invention relates to the technical field of medical and health clinical testing, and in particular to a microneedle device of a peripheral blood collection device and a fixing method thereof. Background Art

[0002] In the healthcare sector, peripheral blood collection is a common clinical testing method. Venous blood collection generally uses a vacuum blood collection system. The lancet is inserted into the vein at an angle of 15°-30°. After blood returns, the needle tip is slightly advanced along the vein. A vacuum blood collection tube is inserted into the other end of the lancet. Blood will automatically flow into the tube under the action of negative pressure, and a sufficient amount of blood is collected according to the test item requirements. Arterial blood collection generally uses an arterial lancet with a short and sharp bevel to reduce damage to the arterial wall. The lancet is inserted at a 30°-45° angle to the skin above two fingers. After puncturing the artery, dark red blood can be seen automatically flowing into the syringe or lancet. After collecting a sufficient amount of blood, the needle is quickly removed. Capillary blood collection usually uses a three-edged needle, a blood collection needle or a special blood collection pen. The three-edged needle or blood collection pen pierces the skin at the blood collection site with a depth of 2-3 mm to allow the blood to flow out naturally. If bleeding is not smooth, you can gently massage the surrounding tissue after piercing the skin to promote blood outflow, and collect blood with a capillary blood collection tube or a routine blood test glass tube.

[0003] The aforementioned blood collection procedure is difficult, requiring skilled medical personnel with puncture techniques. Furthermore, due to the limitations of the blood collection device, the patient experiences significant pain, and needle phobias can be stressful, leading to needle and blood phobia. Furthermore, the blood collection process often involves insufficient blood volume, making it insufficient for larger blood sample tests. Furthermore, manual pressure and other procedures are required, creating insurmountable challenges for patients, particularly the elderly and children.

[0004] Microneedle blood collection technology was developed to address the challenges of peripheral blood collection. Microneedle blood collection primarily relies on microneedles penetrating the skin's surface, creating tiny channels for extracting interstitial fluid or capillary blood. Microneedles, approximately 50-1000 microns in length, can penetrate the stratum corneum without penetrating the dermis, avoiding nerve endings and blood vessels, thereby reducing pain. In the late 1990s, a team at Georgia Institute of Technology in the United States first used microneedles in transdermal drug delivery research, laying the foundation for the development of microneedle blood collection technology. From 2000 to 2010, researchers conducted early exploration of microneedle blood collection technology, focusing primarily on microneedle material development, structural design, and animal testing to verify its feasibility. After 2010, microneedle blood collection technology gradually entered the clinical application stage, with the emergence of products such as Seventh Sense's TAP microneedle blood collection system and BGI's Bloomics® disposable peripheral blood collection system. After years of research and development, the applicant has launched the microneedle array blood collection system.

[0005] During the research and development, the applicant discovered that the existing microneedle blood collection devices use two types of microneedle structures, namely: an axe-shaped needle that borrows from the traditional blood collection needle, and a new type of sheet metal needle. The axe-shaped needle needs to be configured on a non-metallic mounting base, and its pain is relatively obvious. In tests on different populations, problems such as unsuccessful blood collection and insufficient bleeding volume often occur. Although the sheet metal needle can greatly reduce the pain, due to structural layout, assembly and other reasons, insufficient bleeding volume often occurs. In addition, due to the adhesive assembly method, the microneedle falls off during use, or the microneedle remains on the skin during use and fails to retract into the blood collection device with the blood collection device's rebound mechanism. Furthermore, due to conditions such as cargo handling, transportation, and long-term storage, the connection strength between the sheet metal needle and the base will also be weak. Even though the applicant has developed a technology that can repeatedly form a vacuum, this is still a remedial technical means to solve the problems of the existing technology. How to ensure that the amount of bleeding is sufficient at one time has become a difficult problem for the microneedle blood collection system. Obviously, extending the puncture depth of the microneedles or increasing the number of microneedles can achieve a more ideal bleeding volume, but for patients with more obvious pain, this is still not the best solution. During the continued research and development, the technicians found that when testing the blood collection device, the microneedles occasionally fell off when pressing the blood collection device button. As the pressure continued, the microneedles were ejected like bullets. In some cases, the microneedles pierced the skin and remained on the skin during the blood collection process.

[0006] In commonly used microneedle array blood collection systems, the outer diameter of the annular base at the bottom of the microneedles is approximately 10mm, and the thickness of the annular base ranges from 0.1 to 0.15mm. Given these size limitations, addressing the issues of insufficient blood flow and the risk of microneedle dislodgement remains a pressing challenge in this technology.

[0007] Therefore, how to provide a microneedle and microneedle device with a reliable structure, capable of withstanding large axial forces and having high blood collection efficiency is an important technical problem that needs to be solved urgently in the current field of medical and health clinical testing technology. Summary of the Invention

[0008] The present invention aims to provide a microneedle and device for a blood collection device. By optimizing the geometric structural parameters of the microneedle, it is ensured that it can efficiently penetrate the skin surface and form a tiny channel suitable for blood outflow during the blood collection process, thereby ensuring that the structure is reliable, can withstand large axial forces, and has high blood collection efficiency.

[0009] A blood collection microneedle comprises an annular base and sheet metal needles surrounding the base, wherein the sheet metal needles are perpendicular to the annular base; the characteristics are: the width of the sheet metal needles is 0.5 mm or more, the thickness of the sheet metal needles is 0.12 mm or more, the height of the sheet metal needles is 2.1 mm or more, the number of the sheet metal needles is greater than or equal to 15, and the material hardness of the sheet metal needles must reach HV370 or above.

[0010] Furthermore, the blade of the sheet metal needle is single-edged or double-edged, and the blade width is 0.05 mm or more.

[0011] Furthermore, a through hole is provided on the annular base.

[0012] A blood collector microneedle device comprises a blood collector microneedle and a needle holder; the needle holder is placed below the blood collector microneedle, and a raised cylinder is provided on the contact interface between the needle holder and the blood collector microneedle. The number of the raised cylinders matches the number of through holes on the annular base of the blood collector microneedle, and the outer diameter of the raised cylinder is adapted to the inner diameter of the through hole on the annular base; the raised cylinder is melted by hot melting to form an inverted fixation.

[0013] Furthermore, the thickness of the undercut is greater than twice the thickness of the annular base.

[0014] Furthermore, the microneedle device of the blood collection device is fixedly connected to the microneedle seat module by screws.

[0015] A blood collector microneedle device comprises a blood collector microneedle, a cover plate and a microneedle seat module; the lower surface of the cover plate is provided with an annular groove and a columnar protrusion; the outer diameter of the annular groove under the cover plate matches the inner diameter of the annular base of the blood collector microneedle; the columnar protrusion matches the mounting groove of the microneedle seat module; the cover plate ultrasonically welds the blood collector microneedle to the microneedle seat module.

[0016] Furthermore, an interference fit column is provided on the lower surface of the cover plate to replace the columnar protrusion, and the interference fit column is connected to the mounting groove of the microneedle seat module in an interference fit manner.

[0017] A blood collector microneedle device comprises a blood collector microneedle, a screw and a microneedle seat module; the screw fixes the blood collector microneedle on the microneedle seat module; the outer diameter of the screw nut is larger than the inner diameter of the annular base of the blood collector microneedle.

[0018] A blood collector microneedle device includes a blood collector microneedle, a transfer piece and a microneedle seat module; the transfer piece fixes the blood collector microneedle on the microneedle seat module; the transfer piece includes a panel and a buckle, the buckle is arranged below the panel, and the buckle passes through the annular base and is clamped on the microneedle seat module.

[0019] Furthermore, convex strips are provided on the contact surface between the transfer member and the annular base.

[0020] A blood collector microneedle device comprises a blood collector microneedle and a microneedle seat module; the blood collector microneedle is directly injection molded onto the microneedle seat module; the connection between the microneedle seat module and the blood collector microneedle is nut-shaped, which fixes the microneedle module and the blood collector microneedle together.

[0021] A blood collector microneedle device comprises a blood collector microneedle, an elastic snap adapter and a microneedle seat module; a snap is provided on the bottom surface of the elastic snap adapter, the blood collector microneedle is injection molded onto the elastic snap adapter by injection molding, and then clamped onto the microneedle seat module by the snap on the elastic snap adapter.

[0022] A blood collector microneedle device includes a blood collector microneedle and a microneedle seat module; the blood collector microneedle includes a circular base and a sheet metal needle surrounding the annular base, and the sheet metal needle is perpendicular to the circular base; a plurality of inverted structures are provided on the circular base in a symmetrical form; the blood collector microneedle is directly snap-fitted with the microneedle seat module by means of an inverted buckle.

[0023] Furthermore, the undercut structure can be cut from the circular base, formed from sheet metal, or the undercut piece can be directly fixed and connected to the circular base.

[0024] Beneficial effects:

[0025] Compared with the prior art, the present invention has the following beneficial effects:

[0026] 1. The micro-needle of the blood collection device can achieve the desired blood collection volume at one time, with high blood collection efficiency;

[0027] 2. The close connection between the microneedle of the blood collection device and the microneedle holder module ensures a tight connection during processing, assembly, handling, transportation and use, and will not fall off. Even when the axial force of the blood collection device is large, the structure is reliable and the microneedle will not remain on the patient's skin during the blood collection process, avoiding potential risks. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 and Figure 2 Schematic diagram of the structure of the microneedle of the blood collection device at different angles in Example 1 of the present invention;

[0029] Figure 3 This is a schematic diagram of the explosion structure of the microneedle device of the blood collection device according to Example 2 of the present invention;

[0030] Figure 4 This is a schematic structural diagram of the needle holder in the microneedle device of the blood collection device according to Example 2 of the present invention;

[0031] Figure 5 This is a schematic diagram of the explosion structure of the microneedle device of the blood collection device according to Example 2 of the present invention;

[0032] Figure 6 This is a schematic diagram of the explosion structure of the microneedle device of the blood collection device according to Example 3 of the present invention;

[0033] Figure 7 for Figure 6 Schematic diagram of the structure of the middle cover;

[0034] Figure 8 This is a schematic diagram of the explosion structure of the microneedle device of the blood collection device according to Example 4 of the present invention;

[0035] Figure 9 This is a schematic diagram of the explosion structure of the microneedle device of the blood collection device according to Example 5 of the present invention;

[0036] Figure 10-11 for Figure 9 Schematic diagram of the structure of the transfer member of Example 5 at different angles;

[0037] Figure 12 This is a schematic diagram of the explosion structure of the microneedle device of the blood collection device according to Example 6 of the present invention;

[0038] Figure 13 Schematic diagram of another alternative installation method of the microneedle device of the blood collection device in Example 3 of the present invention;

[0039] Figure 14 This is a schematic diagram of the explosion structure of the microneedle device of the blood collection device according to Example 7 of the present invention;

[0040] Figure 15 for Figure 14 A schematic diagram of the structure of the elastic snap adapter;

[0041] Figure 16 This is a schematic diagram of the explosion structure of the microneedle device of the blood collection device in Example 8 of the present invention;

[0042] Figure 17 for Figure 16 Schematic diagram of the structure of the microneedle seat module;

[0043] Figure 18-19 for Figure 16 Schematic diagram of the structure of the blood collection device microneedle at different angles. DETAILED DESCRIPTION

[0044] Example 1

[0045] from Figure 1 and Figure 2 As shown, a blood collection microneedle includes an annular base 1 and a sheet metal needle 2 surrounding the periphery of the annular base, wherein the sheet metal needle 2 is perpendicular to the annular base 1; the inner diameter of the annular base 1 is 4.5 mm, and the outer diameter is 7.0 mm; the width of the sheet metal needle 2 is 0.5 mm, the thickness of the sheet metal needle 2 is 0.12 mm and above, the height of the sheet metal needle 2 is 2.1 mm and above, and the number of the sheet metal needles 2 is greater than or equal to 15.

[0046] The sheet metal needle 2 is perpendicular to the annular base 1 and has a width of 0.5 mm or more. This width design helps to ensure the strength of the microneedle while reducing the resistance and pain when piercing the skin; the thickness of the sheet metal needle 2 is 0.12 mm or more, ensuring that the microneedle has sufficient rigidity to penetrate the skin without bending or breaking; the height is 2.1 mm or more, so that the microneedle can penetrate to an appropriate depth in the skin to promote blood outflow; the number is greater than or equal to 15, forming a dense microneedle array to increase the number of blood collection points, thereby improving the overall blood collection volume.

[0047] To ensure effective sheet metal bending and needle strength, the hardness of the sheet metal needle 2 must be at least HV370. Experimental results show that materials with a hardness lower than HV370 can cause microneedles to deform, break, or fail to effectively penetrate the skin during use, thus affecting blood collection efficiency. Using materials with a hardness of HV370 or higher ensures that the microneedles maintain their shape and performance during puncture, effectively penetrating the skin's surface and forming a stable microchannel, thereby improving blood collection efficiency.

[0048] To ensure that the sheet metal needles quickly pierce the skin, the blade of the sheet metal needle 2 can be single-edged or double-edged, with a blade width of 0.05mm or more. The blade of the sheet metal needle 2 can be single-edged or double-edged, with a blade width of 0.05mm or more. This blade design helps the microneedles pierce the skin quickly and accurately, reducing tissue damage and promoting smooth blood flow.

[0049] In order to verify the influence of the above parameters on the blood collection efficiency, the applicant conducted a large number of experiments. The experimental results show that when the width of the sheet metal needle is 0.5mm, the thickness is 0.12mm, the height is 2.1mm, and the number is 15, combined with the material with a hardness of HV370 or above, there is no substandard blood collection. If any of the above parameters is lowered, the blood collection success rate will be lower than 95%, the pain of the experimental subjects will increase, and the amount of blood collected will be significantly insufficient. By adjusting the combination of these parameters, such as increasing the number of microneedles or optimizing the blade design, the blood collection efficiency can be further improved. These experiments fully demonstrate the effectiveness and reliability of the microneedle structural parameters and technical solutions proposed in the present invention. Therefore, the blood collection device microneedles of the present invention can significantly improve the blood collection efficiency through the synergistic effect of the above-mentioned specific structural parameters and material selection, and solve the problems of insufficient blood collection, obvious pain, and loose microneedle connection existing in the prior art.

[0050] Furthermore, the annular base 1 is provided with through holes 3, the number of which is 12 or more, and the inner diameter of which is 0.5 mm or more. Providing through holes in the annular base 1 not only helps reduce the weight of the base, which is very important for the lightweight design of the blood collection device, but also improves the firmness of the blood collection device microneedle when installed with the needle holder or other components, increases the contact surface between the blood collection device microneedle and its fixing, and ensures that the blood collection device microneedle does not fall off during use.

[0051] Example 2

[0052] from Figure 1-Figure 5 As shown, a blood collector microneedle device includes a blood collector microneedle and a needle holder 4, the blood collector microneedle is the blood collector microneedle in Example 1; the needle holder 4 is placed below the blood collector microneedle, and a raised cylinder 5 is provided on the contact interface between the needle holder 4 and the blood collector microneedle, the number of the raised cylinders 5 matches the number of through holes on the annular base of the blood collector microneedle, the outer diameter of the raised cylinder 5 is adapted to the inner diameter of the through hole on the annular base 1, the blood collector microneedle is placed on the needle holder 4, the raised cylinder 5 passes through the through hole 3, and the raised cylinder 5 is melted by hot melting to form an undercut and fixed; considering the need to control the vertical edge height of the sheet metal needle 2, the undercut formed by hot melting cannot be too thick, and the thickness of the undercut can be greater than 2 times the thickness of the annular base.

[0053] Furthermore, the microneedle device of the blood collection device is fixedly connected to the microneedle seat module 7 by screws 6. The microneedle seat module 7 is placed in the blood collection device and drives the microneedle device of the blood collection device to move during the emission and recovery stages of the blood collection process.

[0054] Example 3

[0055] from Figure 6 and Figure 7 As shown, a microneedle device for a blood collector includes a microneedle, a cover plate 8, and a microneedle seat module 9. The microneedle is the microneedle of Example 1. The upper surface of the cover plate 8 is flat, and the lower surface is provided with an annular groove 10 and a cylindrical protrusion 11. The annular groove 10 and the cylindrical protrusion 11 are coaxially arranged. The outer diameter of the annular groove 10 below the cover plate 8 matches the inner diameter of the annular base of the microneedle. The cylindrical protrusion 11 matches the mounting groove of the microneedle seat module 9. The cover plate 8 ultrasonically welds the microneedle to the microneedle seat module 9. The ultrasonic welding utilizes high-frequency vibration energy to melt the plastic at the welding site, thereby achieving a secure connection between the microneedle and the microneedle seat module 9. This structure has low cost and simple process. The ultrasonic welding also forms a strong weld joint, effectively preventing the microneedle from loosening during use and providing high structural reliability.

[0056] In addition to the above ultrasonic welding, Figure 13 As shown, the interference fit column 12 on the lower surface of the cover plate 8 is connected to the mounting groove of the microneedle seat module 13 by an interference fit method; this fixing method is simple, provides better protection for the microneedles of the blood collection device, has low mold opening costs, and is therefore more efficient.

[0057] Example 4

[0058] from Figure 8 As shown, a microneedle device for a blood collection device includes a microneedle, a screw 14, and a microneedle holder module 15. The microneedle is the microneedle described in Example 1. The screw 14 secures the microneedle to the microneedle holder module 15. The outer diameter of the screw cap of the screw 14 is larger than the inner diameter of the annular base of the microneedle. This method has low equipment requirements, is easy to operate and control, is low in cost, and provides reliable fixation. It can withstand large axial forces and effectively prevent the microneedle from being unable to retract after puncture.

[0059] Example 5

[0060] from Figure 9-11 As shown, a blood collection microneedle device includes a blood collection microneedle, a transfer member 16, and a microneedle seat module 17; the blood collection microneedle is the blood collection microneedle in Example 1; the transfer member 16 fixes the blood collection microneedle to the microneedle seat module; the transfer member 16 includes a panel and a buckle 18, the buckle 18 is arranged below the panel, the outer diameter of the panel is larger than the inner diameter of the annular base of the blood collection microneedle, and the buckle 18 passes through the annular base and is clamped to the microneedle seat module 17; this connection method can make the entire fixing structure simple and reliable. At the same time, this fixing method can be combined with machine automated production to improve production efficiency and reduce manual operation costs and error rates.

[0061] Furthermore, in order to ensure that the transfer member is in close contact with the annular base 1 , a ridge 19 is provided on the contact surface between the transfer member 16 and the annular base 1 , and the ridge 19 ensures that the contact surface is in close contact after installation.

[0062] Example 6

[0063] from Figure 12 As shown, a blood collector microneedle device includes a blood collector microneedle and a microneedle seat module; the blood collector microneedle is the blood collector microneedle in Example 1; the blood collector microneedle is directly injection molded on the microneedle seat module; the connection 20 between the microneedle seat module and the blood collector microneedle is in the shape of a nut, which fixes the microneedle module and the blood collector microneedle together; this one-piece fixing method eliminates the intermediate installation steps, reduces the number of parts and assembly processes, has higher stability and reliability, can effectively avoid the problem of microneedle fixation failure caused by loose parts or loose connections, and is also beneficial to improving production efficiency and product quality stability.

[0064] Example 7

[0065] from Figure 14-15 As shown, a microneedle device for a blood collection device includes a blood collection microneedle, an elastic snap adapter 21, and a microneedle holder module 22. The blood collection microneedle is the blood collection microneedle described in Example 1. The elastic snap adapter 21 has a snap on its bottom surface, and the blood collection microneedle is injection molded onto the elastic snap adapter 21. The snap on the elastic snap adapter 21 then snaps onto the microneedle holder module 22. This overall structure is simple and reliable, and can be produced automatically by machine, resulting in high production efficiency.

[0066] Example 8

[0067] from Figure 16-19 As shown, a blood collection microneedle device includes a blood collection microneedle 24 and a microneedle seat module 25; the blood collection microneedle 24 is different from the blood collection microneedle in Example 1; the blood collection microneedle 24 includes a circular base 26 and a sheet metal needle surrounding the periphery of the circular base, and the sheet metal needle is perpendicular to the circular base 26; other parameters are the same as those in Example 1; a plurality of undercut structures 27 are provided on the circular base 26, Figure 16-19The undercut structure 27 is a symmetrical undercut member disposed on the lower surface of the circular base 26. The undercut member can be cut from the circular base, formed from sheet metal, or directly fixed to the circular base. The microneedles of the blood collection device engage directly with the microneedle holder module clip 25 through this undercut mechanism. This overall structure is simple, reliable, and low-cost. It can also be manufactured automatically without the need for excessive parts or complex processes, resulting in high production efficiency and facilitating large-scale production.

[0068] Experimental verification shows that the microneedles of the blood collection device and the microneedle device of the blood collection device in the embodiments of the present invention have excellent bending effect of the sheet metal needles, strong strength, and the one-time bleeding volume meets the requirements, and there is no problem of the microneedles being loosely connected or staying on the skin.

[0069] The above embodiments are only specific descriptions of feasible implementation methods of the present invention and are not intended to limit the scope of patent protection of the present invention. The structures of the blood collector microneedles in the above embodiments 1-7 are the same, but the connection methods of the blood collector microneedles and the microneedle seat module are different. According to the description of the embodiments in the specification, those skilled in the art can clearly and unambiguously know that the microneedle seat module needs to be adapted to the blood collector microneedles and other components, and they are not exactly the same. The core invention of the present invention is not in the specific structure of the microneedle seat module, which can be easily obtained by those skilled in the art based on the description of the blood collector microneedles and other matching components and the embodiments; the structure of the blood collector microneedle in the above embodiment 8 is different from the structure of the blood collector microneedle in embodiment 1. According to the description, those skilled in the art can clearly and unambiguously know that the adjustment of the blood collector microneedle is also to adapt it to the fixation of the microneedle seat module. The core technology that the present invention requests to be protected is the blood collector microneedle and the fixing method of the blood collector microneedle. As long as it involves one of the core inventive concepts of the present invention and the technical means for realizing the inventive concepts, it belongs to the object of protection of this patent.

Claims

1. A microneedle for a blood collection device, comprising an annular base and a sheet metal needle surrounding the base, wherein the sheet metal needle is perpendicular to the annular base; characterized in that: The width of the sheet metal needle is 0.5 mm or more, the thickness of the sheet metal needle is 0.12 mm or more, the height of the sheet metal needle is 2.1 mm or more, the number of the sheet metal needles is greater than or equal to 15, and the material hardness of the sheet metal needle must reach HV370 or more.

2. The microneedle of a blood collection device according to claim 1, characterized in that: A through hole is provided on the annular base.

3. A microneedle device for a blood collection device, comprising the microneedle device for a blood collection device according to any one of claims 1 to 2, characterized in that: It also includes a needle holder; the needle holder is placed below the microneedle of the blood collector, and a raised cylinder is provided on the contact interface between the needle holder and the microneedle of the blood collector, the number of the raised cylinders matches the number of through holes on the annular base of the microneedle of the blood collector, and the outer diameter of the raised cylinder is adapted to the inner diameter of the through hole on the annular base; The raised cylinder is melted by hot melting to form an undercut fixation.

4. A microneedle device for a blood collection device according to claim 3, characterized in that: The thickness of the undercut is greater than twice the thickness of the annular base.

5. A microneedle device for a blood collection device according to any one of claims 3 or 4, characterized in that: The microneedle device of the blood collection device is fixedly connected to the microneedle seat module by screws.

6. A blood collection microneedle device, comprising the blood collection microneedle according to any one of claims 1 to 2, characterized in that: It also includes a cover plate and a microneedle seat module; the lower surface of the cover plate is provided with an annular groove and a columnar protrusion; the outer diameter of the annular groove under the cover plate matches the inner diameter of the annular base of the blood collector microneedle; the columnar protrusion matches the mounting groove of the microneedle seat module; the cover plate ultrasonically welds the blood collector microneedle to the microneedle seat module.

7. The microneedle device for a blood collection device according to claim 6, characterized in that: An interference fit column is provided on the lower surface of the cover plate to replace the columnar protrusion, and the interference fit column is connected to the mounting groove of the microneedle seat module in an interference fit manner.

8. A microneedle device for a blood collection device, comprising the microneedle device for a blood collection device according to any one of claims 1 to 2, characterized in that: It also includes a screw and a microneedle seat module; the screw fixes the blood collection device microneedle on the microneedle seat module; the outer diameter of the screw nut is larger than the inner diameter of the annular base of the blood collection device microneedle.

9. A microneedle device for a blood collection device, comprising the microneedle device for a blood collection device according to any one of claims 1 to 2, characterized in that: It also includes a transfer piece and a microneedle seat module; the transfer piece fixes the blood collection device microneedle on the microneedle seat module; the transfer piece includes a panel and a buckle, the buckle is arranged below the panel, and the buckle passes through the annular base and is clamped on the microneedle seat module.

10. A microneedle device for a blood collection device, comprising the microneedle for a blood collection device according to any one of claims 1 to 2, characterized in that: It also includes a microneedle seat module; the blood collector microneedle is directly injection molded on the microneedle seat module; the connection between the microneedle seat module and the blood collector microneedle is in the shape of a nut, which fixes the microneedle seat module and the blood collector microneedle together.

11. A microneedle device for a blood collection device, comprising the microneedle device for a blood collection device according to any one of claims 1 to 2, characterized in that: It also includes an elastic snap adapter and a microneedle seat module; a snap is set on the bottom surface of the elastic snap adapter, and the sheet metal needle is injection molded on the elastic snap adapter by injection molding, and then clamped on the microneedle seat module through the snap on the elastic snap adapter.

12. A microneedle for a blood collection device, comprising a circular base and a sheet metal needle surrounding the base, wherein the sheet metal needle is perpendicular to the base; characterized in that: The width of the sheet metal needle is 0.5 mm or more, the thickness of the sheet metal needle is 0.12 mm or more, the height of the sheet metal needle is 2.1 mm or more, and the number of the sheet metal needles is greater than or equal to 15; the hardness of the sheet metal needle material must reach HV370 or above; and multiple inverted structures are arranged on the base in a symmetrical form.

13. A blood collection microneedle device, comprising the blood collection microneedle according to claim 12, characterized in that: The microneedle of the blood collection device is directly snap-fitted with the microneedle seat module in an inverted manner.

14. The microneedle device for a blood collection device according to claim 13, wherein: The undercut structure can be cut from the base, formed by sheet metal, or the undercut piece can be directly fixed and connected to the base.