Micro-needle array clamping and puncturing auxiliary device with adjustable puncturing depth and force and use method of micro-needle array clamping and puncturing auxiliary device

Abstract

The invention discloses a micro-needle array clamping and puncturing auxiliary device with adjustable puncturing depth and force and a use method, and belongs to the technical field of medical instruments, a micro-needle array mounting clamping plate is matched with a lower ejection rod, sheet-shaped micro-needle array substrates and positioning spacers are symmetrically mounted on two side surfaces, and the micro-needle array mounting clamping plate and the sheet-shaped micro-needle array substrates and the positioning spacers are matched with puncturing depth adjusting sheets for use. The piercing depth adjusting sheets are symmetrically mounted on the lower end clamping head and are matched with the microneedle array mounting clamping plate; the lower end clamping head is used for connecting the shell and the piercing depth adjusting sheet and providing a sliding channel for the lower ejection rod; the lower ejection rod penetrates from the lower end clamping head, and the lower ejection rod is sleeved with the limiting spring. A trigger switch reset spring and a trigger switch are placed on the shell, and the upper ejection rod is used in cooperation with the trigger switch, so that graded loading positioning of the loading spring is achieved. The sheet-shaped coplanar microneedle array is simply assembled to form the three-dimensional different-plane microneedle array, regulation and control of the arrangement rule of needle bodies in the microneedle array can be achieved, the needle applying speed and depth can be regulated and controlled, and physical safety protection is provided for the whole process.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of medical devices, and relates to a microneedle array clamping and puncture assisting device with adjustable puncture depth and force, and a use method. BACKGROUND

[0002] A microneedle (MN) is a micro-needle with a needle body diameter of tens of microns to several millimeters and a tip curvature radius of several microns to tens of microns. The microneedle or microneedle array only penetrates the stratum corneum of the skin without touching the deep tissue, forms a micron-level channel on the skin surface, improves the transdermal drug delivery efficiency, and ensures painless and minimally invasive. The microneedle can be used for transdermal delivery of drugs such as insulin, vaccines, and anesthetics, and has broad application prospects.

[0003] Obviously, the biggest advantage of the microneedle over the traditional transdermal drug delivery is minimally invasive and painless. Studies have shown that the pain felt during microneedle puncture is related to the puncture depth, puncture speed, and properties of the puncture object in addition to the properties of the microneedle itself (such as needle height and arrangement). The deeper and slower the puncture, the more obvious the pain. The influence of the puncture object is more complex and is related to the age, gender, and specific site of the puncture object. Therefore, the microneedle and its array must have a corresponding clamping and assisting puncture device during puncture, so as to effectively control the puncture depth, puncture speed, and microneedle array arrangement according to the properties of the drug delivery object, and provide necessary safety protection during puncture to prevent injuries to the puncture object caused by misoperation or structural failure.

[0004] At present, many research teams and institutions are committed to the research of micro-needle clamping and penetration auxiliary devices. For example, a Chinese invention patent (CN119386363A) discloses a micro-needle high-speed implantation device, which uses compressed gas to push the micro-needle to fly at high speed in an acceleration trajectory. The penetration depth can be limited by the base of the micro-needle, and the deformation can be reduced by the hardening phenomenon under high strain rate of the skin. However, this technology is only suitable for single micro-needle independent operation and cannot support needle array operation. In addition, an external gas source is required, and the penetration force is completely determined by the gas source pressure, lacking flexible adjustment mechanism for different skins. A manual micro-needle application tool and method disclosed in a Chinese invention patent (CN119855629A) can make the micro-needle insert along the guide path, and the base guide rail can ensure the vertical insertion angle. However, this technology has the problem of insufficient manual force control accuracy. In summary, the existing micro-needle clamping and penetration auxiliary devices still have the following problems: (1) Most of them adopt integrated structure, that is, the needle applicator and the micro-needle array are designed in an integrated manner. The density and arrangement of the micro-needle array cannot be adjusted after processing, and it is difficult to flexibly adjust according to the demand changes; (2) The penetration depth and speed cannot be independently adjusted, and it is not easy to control the parameters when the needle application object (such as children, the elderly) or the needle application site is different; (3) The needle applicator lacks physical limit, and misoperation may cause excessive penetration and bleeding or infection, and in severe cases, it may even cause the fracture of the micro-needle body. Especially when the micro-needle is made of brittle materials such as silicon, the broken micro-needle fragments may be difficult to remove from the skin, causing pain and safety risks to the needle application object.

[0005] The existence of the above problems seriously restricts the popularization and application of micro-needle technology, and there is an urgent need to develop a micro-needle penetration auxiliary device suitable for various application scenarios. SUMMARY

[0006] In view of the problems in the prior art that the micro-needle array has problems in clamping mode, array density, penetration depth, penetration speed control and safety protection, the present application provides a micro-needle array clamping and penetration auxiliary device with adjustable penetration depth and force (speed) and a use method thereof. Combined with the previous invention of a planar metal micro-needle array (patent number: ZL20190391947.2), the planar metal micro-needle array can be simply assembled to form a three-dimensional micro-needle array, and the arrangement rule, number and density of the micro-needle array can also be effectively controlled to adapt to different operation requirements.

[0007] To achieve the above purpose, the present application provides the following technical solutions:

[0008] The utility model provides a kind of adjustable micro-needle clamping and puncture auxiliary device of depth and force, and the micro-needle clamping and puncture auxiliary device includes micro-needle array installation card plate 1, sheet micro-needle array substrate 2, positioning septum 3, puncture depth adjusting piece 4, lower end clamp 5, trigger switch reset spring 12, trigger switch 13, upper ejection rod sliding guide head 18, force handle 19, shell 10 and the lower ejection rod 6, limiting spring 7, limiting spring compression gasket 8, limiting spring compression bolt 9, loading head 14, loading spring compression gasket 15, loading spring 16, upper ejection rod 17 in the inside of shell 10, and trigger switch installation buckle 11 installed in the outside of shell.

[0009] The upper part of the microneedle array mounting card 1 is matched with the lower ejection rod 6 and is fixed to the lower ejection rod 6; the two side faces of the microneedle array mounting card 1 are sequentially and symmetrically installed with the sheet-shaped microneedle array substrate 2 and the positioning spacer 3 through bolts, wherein the lower edge of the sheet-shaped microneedle array substrate 2 is processed with microneedle bodies 2-2, and after combination, multiple sheet-shaped microneedle arrays become a three-dimensional microneedle array, the spacing distance of the sheet-shaped microneedle array can be adjusted by adjusting the thickness of the positioning spacer 3 or the number of the positioning spacer 3 between two sheet-shaped microneedle array substrates 2, and the spacing distance between each needle body 2-2 on the sheet-shaped microneedle array can be determined during processing, so that the number and arrangement of the needle bodies of the three-dimensional microneedle array can be finally adjusted. The microneedle array mounting card 1 is further provided with a first positioning shoulder 1-3, which is used in cooperation with the penetration depth adjusting sheet 4 to realize physical limiting of the penetration depth of the microneedle. The penetration depth adjusting sheet 4 is provided with two identical structures and is symmetrically installed on the lower end clamp 5 and cooperates with the first positioning shoulder 1-3 of the microneedle array mounting card 1. The lower end clamp 5 is a hollow cylindrical structure as a whole, which is used for connecting the shell 10 and the penetration depth adjusting sheet 4 and also provides a sliding channel for the lower ejection rod 6. The upper end of the lower ejection rod 6 penetrates from the lower end of the lower end clamp 5, the limiting spring 7 is sleeved on the upper end of the lower ejection rod 6, the limiting spring pressing gasket 8 and the limiting spring pressing bolt 9 are sequentially pressed on the limiting spring 7, the limiting spring pressing bolt 9 is matched with the lower ejection rod 6 to complete the installation. The limiting spring 7 axially limits the lower ejection rod 6 and the microneedle array mounting card 1 connected thereto. The shell 10 is provided with two symmetrically arranged blind holes in the middle position of the outer wall, which are used for placing the trigger switch reset spring 12. The trigger switch mounting buckle 11 is provided with two symmetrically placed trigger switches 13 between the two trigger switch mounting buckles 11, and the trigger switch 13 can be smoothly rotated. The upper end of the loading head 14 is matched and connected with the upper ejection rod 17, and the lower end is used for hitting the limiting spring pressing bolt 9. The upper end of the upper ejection rod 17 is connected with the lower end of the force applying handle 19, the upper ejection rod 17 is close to the two side walls of the upper end and is matched with the trigger switch 13 to realize the staged loading and positioning of the loading spring, and the lower end of the upper ejection rod 17 is matched and connected with the upper end of the loading head 14. The upper ejection rod sliding guide head 18 is installed on the shell 10. The force applying handle 19 is matched and connected with the upper ejection rod 17.

[0010] The specific structure of each part is described as follows:

[0011] The microneedle array mounting card plate 1 is prepared from a metal material and has a plate structure, and the upper end has a tapered structure to reduce the volume and weight; the upper part of the microneedle array mounting card plate 1 is provided with an elongated slot 1-1, which is used in cooperation with the fourth positioning hole 6-3 on the bottom flange 6-2 of the lower ejection rod 6 to mount and fix the microneedle array mounting card plate 1 to the lower ejection rod 6, and the elongated slot 1-1 is designed to be elongated to facilitate position adjustment and reduce the position and size precision requirements of the lower ejection rod 6 bottom mounting positioning hole 6-2 and 6-3; the lower part of the microneedle array mounting card plate 1 is provided with four first positioning holes 1-2, which correspond to the second positioning holes 2-1 on the sheet-shaped microneedle array substrate 2 and the third positioning holes 3-1 on the positioning spacer 3, and the sheet-shaped microneedle array substrate 2 and the positioning spacer 3 are fixed to the microneedle array mounting card plate 1 by bolts. Further, the four first positioning through holes 1-2 are arranged symmetrically left and right, and the center connecting line forms an isosceles trapezoid, which can better limit the movement degree of freedom of the sheet-shaped microneedle array substrate 2; the lower end of the microneedle array mounting card plate 1 is provided with first positioning shoulders 1-3 on both sides, which are used in cooperation with the penetration depth adjusting sheet 4 to realize physical limiting of the microneedle penetration depth.

[0012] The sheet-shaped microneedle array substrate 2 is prepared from a metal material and has a rectangular sheet structure, and the middle is provided with four second positioning holes 2-1, which correspond to the four first positioning through holes 1-2 of the microneedle array mounting card plate 1 and the third positioning holes 3-1 on the positioning spacer 3; the lower edge of the sheet-shaped microneedle array substrate 2 is processed with a certain number of microneedle bodies 2-2, and the size, number and arrangement of the microneedle bodies 2-2 can be adjusted flexibly according to needs.

[0013] The positioning spacer 3 can be prepared from a metal material or a polymer material and has a rectangular sheet structure, and the middle is provided with four third positioning holes 3-1, which correspond to the four first positioning through holes 1-2 of the microneedle array mounting card plate 1 and the second positioning holes 2-1 on the sheet-shaped microneedle array substrate 2. The spacing distance of the sheet-shaped microneedle array can be adjusted by adjusting the thickness of the positioning spacer 3 itself or the number of positioning spacers 3 placed between the two sheet-shaped microneedle array substrates 2 to realize the arrangement regulation control of the microneedle array.

[0014] Further, the microneedle array mounting card plate 1, the sheet-shaped microneedle array substrate 2 and the positioning spacer 3 are installed as follows: one microneedle array mounting card plate 1 is placed in the middle, and sheet-shaped microneedle array substrates 2 and positioning spacers 3 are placed in sequence and at intervals on both sides, and after installation, bolts are used to fix the positioning holes to make the sheet-shaped microneedle array become a three-dimensional microneedle array, and the arrangement of the microneedle array such as the number, density and height distribution of the needle bodies can be controlled by adjusting the number of sheet-shaped microneedle array substrates 2 and positioning spacers 3, the thickness of the microneedle array mounting card plate 1 and the height of the needle body in the sheet-shaped microneedle array substrate 2, to realize personalized needle application.

[0015] The two said piercing depth adjusting pieces 4 are made of metal material and have a hook-shaped structure. The upper end long edge strip 4-1 can be inserted into the rectangular through hole 5-3 of the lower end clamping head 5 from both sides to be fixed, and the width of the microneedle array mounting card 1 is adapted by controlling the depth of insertion; the lower end hook-shaped structure is the second positioning shoulder 4-2, which is used in cooperation with the first positioning shoulder 1-3 on the microneedle array mounting card 1 to realize physical limiting of the microneedle piercing depth and ensure safety.

[0016] The lower end clamping head 5 is made of metal material and has a hollow cylindrical shape, which is divided into upper end and lower end along the axial direction of the cylinder. The upper end is provided with an internal thread hole 5-1 for connecting and fixing with the external thread 10-4 at the lower end of the shell 10. The middle position of the internal structure of the lower end is provided with a first square chute 5-2, the side length of which is smaller than the inner diameter of the internal thread hole 5-1, which provides an axial sliding channel for the lower ejection rod 6, and the square design can prevent the lower ejection rod 6 from rotating circumferentially. The lower end structure of the lower end clamping head 5 is provided with a rectangular through hole 5-3 perpendicular to the axis and passing through the axis, and the upper end long edge strip 4-1 of the piercing depth adjusting piece 4 is placed in the rectangular through hole 5-3. The first threaded hole 5-4 is arranged at the edge of the corresponding position of the single side surface of the lower end clamping head 5 and the rectangular through hole 5-3, which is used for fixing the upper end long edge strip 4-1 of the piercing depth adjusting piece 4 by bolts.

[0017] Further, the cooperation between the lower end clamping head 5 and the piercing depth adjusting piece 4 is as follows: the upper end long edge strip 4-1 of a piercing depth adjusting piece 4 is inserted into the rectangular through hole 5-3 on one side of the lower end clamping head 5, the depth of insertion is adjusted according to the width of the microneedle array mounting card 1, the first positioning shoulder 1-3 of the microneedle array mounting card 1 is tightly matched with the second positioning shoulder 4-2 of the piercing depth adjusting piece 4, and then the piercing depth adjusting piece 4 is fixed by using bolts through the first threaded hole 5-4. The other side of the piercing depth adjusting piece 4 is installed and used in the same way.

[0018] Further, the cooperation between the microneedle array mounting card 1 and the piercing depth adjusting piece 4 is as follows: when the microneedle piercing operation is performed, the first positioning shoulder 1-3 can contact the second positioning shoulder 4-2 of the piercing depth adjusting piece 4 to limit the microneedle from continuing to pierce downward, thereby accurately realizing the control of the microneedle piercing depth and the protection of the piercing object. The physical regulation of the piercing depth can be realized by adjusting the height of the first positioning shoulder 1-3 and the thickness of the second positioning shoulder 4-2.

[0019] The lower ejection rod 6 is made of metal material and has a square cross-section long rod. The upper end is provided with a second threaded hole 6-1 for cooperation with the limiting spring compression bolt 9. The lower end part of the material is removed on one side, and the remaining part forms a thin flange 6-2, and a fourth positioning hole 6-3 is arranged on the flange.

[0020] Furthermore, the installation of the lower ejector rod 6 and its related components is as follows: Place the micro-needle array mounting plate 1 inside the flange 6-2 of the lower ejector rod 6, aligning the fourth positioning hole 6-3 with the elongated slot 1-1. After adjusting the position, fix it with bolts. Insert the upper end of the lower ejector rod 6 through the lower end of the lower end clamp 5 along the first square slide 5-2. Then, slide the limiting spring 7 down from the upper end of the lower ejector rod 6. Next, press the limiting spring compression washer 8 and the limiting spring compression bolt 9 onto the limiting spring 7 in sequence. Finally, screw the limiting spring compression bolt 9 into the second threaded hole 6-1 to complete the installation.

[0021] Furthermore, the limiting spring 7 is a metal spring used to axially limit the lower ejector rod 6 and the microneedle array mounting plate 1 connected thereto to a certain extent. The stiffness should not be too large, but it should ensure that when the upper ejector rod 17 is lifted (in the state of charging and waiting to apply needles), there is a certain distance between the microneedle substrate 2 and the second positioning shoulder 4-2 of the insertion depth adjustment plate 4, so as to ensure that the microneedle substrate 2 has downward space to accelerate when the upper ejector rod 17 strikes the lower ejector rod 6 (in the state of applying needles). The inner diameter of the limiting spring 7 should be larger than the cross-sectional size of the lower ejector rod 6 so that the latter can be fitted in, but the outer diameter should be smaller than the cross-sectional size of the lower end of the lower end clamp 5 along the first square slide 5-2 to prevent it from sliding out of the first square slide 5-2.

[0022] Furthermore, the limiting spring clamping washer 8 is made of metal, and its inner diameter is larger than the outer diameter of the limiting spring clamping bolt 9 screw, but smaller than the outer diameter of the limiting spring clamping bolt 9 nut and the inner diameter of the limiting spring 7.

[0023] Furthermore, the limiting spring clamping bolt 9 is made of metal, with a round nut at the upper end and a countersunk hole 9-1 at the end of the nut. This countersunk hole facilitates fastening and installation, and is also used in conjunction with the loading head 14 to ensure that the loading force is as close as possible to the axis of the loading rod. The lower end of the limiting spring clamping bolt 9 is a columnar bolt 9-2, which is used in conjunction with the second threaded hole 6-1 at the upper end of the lower ejector rod 6.

[0024] The main body of the housing 10 is a hollow cylindrical structure made of metal. Its interior is a cylindrical cavity 10-1, within which the lower ejector rod 6, limiting spring 7, limiting spring clamping washer 8, limiting spring clamping bolt 9, loading head 14, loading spring clamping washer 15, loading spring 16, and upper ejector rod 17 are all located. The lower outer wall of the housing 10 is provided with external threads, which cooperate with the internal threaded hole 5-1 of the lower end clamp 5, thereby connecting the lower end clamp 5 to the housing 10. The upper inner wall of the cylindrical cavity 10-1 of the housing 10 is threaded to cooperate with the external thread of the upper ejector rod sliding guide head 18, thereby connecting the upper ejector rod sliding guide head 18 to the housing 10; the outer wall near the upper end of the housing 10 is provided with an annular limiting groove 10-2 for limiting the installation of the trigger switch mounting buckle 11; the housing 10 is provided with two symmetrically arranged limiting blind holes 10-3 at the middle position for placing the trigger switch reset spring 12.

[0025] Furthermore, the housing 10 is inserted from the lower ejection rod 6 and screwed into the lower end clamp 5.

[0026] The trigger switch reset spring 12 is a metal spring, which is used in conjunction with the limiting blind hole 10-3 on the housing 10. The outer diameter of the spring is slightly smaller than the inner diameter of the limiting blind hole 10-3.

[0027] The trigger switch mounting clip 11 is made of metal, and there are two clips used in pairs. The overall structure is a semi-circular ring-shaped structure with fins on both sides. The trigger switch mounting clip 11 has a central arc structure 11-1 and fins 11-2 on both sides, with a fifth positioning hole 11-3 in the middle of the fins. The arc structure 11-1 is used to better mount the trigger switch mounting clip 11 onto the annular limiting groove 10-2 of the housing 10, ensuring axial positioning of the trigger switch mounting clip 11. The fins 11-2 are used to provide the fifth positioning hole 11-3; the fifth positioning hole 11-3 is used to place a clamping bolt, which clamps the fins 11-2 on both sides, pressing the trigger switch mounting clip 11 onto the annular limiting groove 10-2 of the housing 10, thus achieving fixation.

[0028] The trigger switches 13 are made of metal and consist of two units. They are irregularly shaped, resembling a bird in their front view. A sixth positioning hole 13-1 is located in the middle of the "bird's" body, a latch 13-2 is located at the upper "beak," and a third threaded hole 13-3 is located on the side of the lower "tail." The sixth positioning hole 13-1 is for inserting a bolt that presses against the fin 11-2 of the trigger switch mounting clip 11. The outer diameter of this bolt is smaller than the inner diameter of the sixth positioning hole 13-1 to ensure that the trigger switch 13 can rotate freely around the bolt. The thickness of the trigger switch 13 is smaller than the distance between the fin 11-2 of the trigger switch mounting clip 11 and the other fin 11-2 to ensure that the trigger switch 13 can rotate freely around the bolt. The latch 13-2 is used to engage with the seventh limiting hole 17-2 of the upper ejector rod 17 to temporarily limit the upper ejector rod 17. The third threaded hole 13-3 is used to insert a bolt to fix the trigger switch reset spring 12.

[0029] The loading head 14 is made of metal and is a hemispherical nut. Its upper end is a fourth threaded hole 14-1, which is connected to the second threaded post 17-3 of the upper ejector rod 17. The lower end is a hemispherical pressure head 14-2, which is used to strike the limit spring clamping bolt 9.

[0030] The loading spring clamping pad 15 is made of metal and is a hollow circular piece. It is placed between the loading head 14 and the loading spring 16 to improve the stability of the spring force.

[0031] The loading spring 16 is a metal spring, and its stiffness is greater than that of the limiting spring 7.

[0032] The upper ejector rod 17 is made of metal and is a long rod with a square cross-section. The upper end of the upper ejector rod 17 is a first threaded post 17-1, which is used to mate and connect with the lower end internal thread 19-2 of the force application handle 19. Several seventh limiting holes 17-2 are symmetrically arranged on both sides of the upper ejector rod 17 near the upper end, which are used to cooperate with the upper end latch 13-2 of the trigger switch 13 to realize the graded loading and positioning of the loading spring. The lower end of the upper ejector rod 17 is a second threaded post 17-3, which is used to mate and connect with the fourth threaded hole 14-1 at the upper end of the loading head 14.

[0033] Furthermore, the installation of the upper ejector rod 17 and its related components is as follows: the loading spring clamping washer 15 and the loading head 14 are inserted into the second threaded post 17-3 of the upper ejector rod 17 and tightened; the loading spring 16 is sleeved from the upper end of the upper ejector rod 17 and then installed into the housing 10; the upper ejector rod sliding guide head 18 is sleeved from the upper end of the upper ejector rod 17 and then screwed onto the housing 10; finally, the force application handle 19 is screwed into the first threaded post 17-1 of the upper ejector rod 17.

[0034] Furthermore, the upper ejection rod sliding guide head 18 is made of metal material and is an integral nut with a square through hole inside, that is, it is provided with a second square slide 18-1 inside, for the ejection rod 17 to slide and restrict its rotation; it is provided with a thread 18-2 on the outside, which is connected to the thread on the inner wall of the upper end of the cylindrical cavity 10-1 on the housing 10.

[0035] Furthermore, the force-applying handle 19 is made of metal and is T-shaped for applying force. The upper part has a long grip 19-1 for easy hand gripping; the lower end has a fifth threaded hole 19-2 for connecting with the first threaded post 17-1 of the upper ejection rod 17.

[0036] Furthermore, two trigger switch mounting clips 11 are symmetrically placed in the annular limiting groove 10-2 of the housing 10, and then a trigger switch 13 is placed between the fins 11-2 of the two trigger switch mounting clips 11, so that the sixth positioning hole 13-1 is aligned with the fifth positioning hole 11-3 on the two trigger switch mounting clips 11, and connected by bolts, but not completely tightened; the other trigger switch 13 is installed in the same way between the fins 11-2 on the other side of the two trigger switch mounting clips 11.

[0037] Furthermore, after the two trigger switch mounting clips 11 are installed and tightened, the distance between the two fins 11-2 is still greater than the thickness of the trigger switch 13, and the inner diameter of the sixth positioning hole 13-1 on the trigger switch 13 is greater than the inner diameter of the fifth positioning hole 11-3 on the trigger switch mounting clips 11, to ensure that the trigger switch 13 can rotate smoothly.

[0038] Furthermore, insert one of the aforementioned trigger switch reset springs 12 into the limiting blind hole 10-3 on the housing 10, rotate and adjust the trigger switch mounting clip 11 so that the limiting blind hole 10-3 on the housing 10 is aligned with the third threaded hole 13-3 on the trigger switch 13, and screw in the bolt from the outside so that the bolt passes through the third threaded hole 13-3 and is engaged in the trigger switch reset spring 12; install the other trigger switch reset spring 12 in the same way, and then tighten the bolts on the fifth positioning hole 11-3 on both trigger switch mounting clips 11 to fix them, completing the installation and fixation of the trigger switch 13 and the housing 10. This completes the installation of the entire needle application structure.

[0039] A method for using a microneedle array clamping and insertion assist device with adjustable insertion depth and force includes the following steps:

[0040] The first step is to control the size, quantity, and arrangement of the microneedle array;

[0041] Based on parameters such as the target of application, the application site, and the characteristics of the drug, determine the size, number, and arrangement of the microneedles in the microneedle array. Select appropriate microneedle array mounting plates 1, microneedle array substrates 2, and positioning spacers 3, install and fix them, and perform necessary disinfection for later use.

[0042] The second step is to adjust the insertion depth;

[0043] Based on requirements, select a suitable insertion depth adjustment piece 4. Theoretically, the insertion depth is equal to the depth of the first positioning shoulder 1-3 of the microneedle array mounting plate 1 plus the height of the microneedle body 2-2 on the sheet-like microneedle array substrate 2, minus the height of the second positioning shoulder 4-2 of the insertion depth adjustment piece 4. After selection, fix the insertion depth adjustment piece 4 to the rectangular through hole 5-3 of the lower end clamp 5 with bolts. It should be noted that the above theoretical insertion depth value is an upper limit; the actual insertion depth will generally be less than this value.

[0044] The third step is to apply the loading force;

[0045] Fix the housing 10, and then pull the handle 19 upward forcefully, so that the upper ejection rod 17 moves upward along the upper ejection rod sliding guide head 18, and the loading spring 16 is compressed and stored; during the lifting process, the latches 13-2 of the trigger switches 13 on both sides are always pressed against the two side walls of the upper ejection rod 17 under the elastic force of the trigger switch reset spring 12.

[0046] According to the need for needle application, the latch 13-2 of the trigger switch 13 is engaged in the seventh limiting hole 17-2 at the corresponding position on both sides of the upper ejector rod 17. At this time, the force application handle 19 can be released. The latch 13-2 engaged in the seventh limiting hole 17-2 will restrict the downward return movement of the upper ejector rod 17.

[0047] It is important to note that the lower the seventh limiting hole 17-2 is positioned, the more severely the loading spring 16 is compressed, resulting in a greater elastic restoring force and a faster insertion speed of the microneedle array. If the spring restoring force provided by the seventh limiting hole 17-2 at the bottom of the latch 13-2 is still insufficient, a loading spring 16 with greater stiffness can be selected; conversely, if the spring restoring force provided by the seventh limiting hole 17-2 at the top of the latch 13-2 is still too large, a loading spring 16 with less stiffness can be selected.

[0048] The fourth step is to administer acupuncture.

[0049] First, adjust the position and disinfect the acupuncture site as necessary. Then, fix the entire device so that the second positioning shoulder 4-2 of the insertion depth adjustment plate 4 is against the acupuncture site, and make the entire device as perpendicular to the acupuncture site as possible. At this time, the microneedle array mounting plate 1, the microneedle array substrate 2 and the positioning spacer 3 will be in a higher position under the action of the limiting spring 7 and will not come into contact with the acupuncture site.

[0050] Secondly, after the position is adjusted, press the lower end of the trigger switches 13 on both sides at the same time to make the nozzle 13-2 slide out from the seventh limiting hole 17-2. Under the restoring force of the loading spring 16, the upper ejector rod 17 will quickly rebound, causing the loading head 14 to quickly strike the limiting spring clamping bolt 9 and the lower ejector rod 6. Finally, the microneedle array at the lower end will quickly pierce the acupuncture site, forming a micron-level drug delivery channel array on its surface. Then, under the restoring force of the limiting spring 7, it will quickly rise and detach from the skin, completing the operation.

[0051] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0052] (1) The present invention can form a three-dimensional heteroplanar microneedle array by simple assembly of sheet-like coplanar microneedle arrays, without the need for direct processing of heteroplanar microneedle arrays, thus reducing the processing difficulty and cost of microneedle arrays;

[0053] (2) The present invention can adjust the spacing of the substrate of the sheet microneedle array by increasing or decreasing the thickness or number of positioning spacers, thereby realizing the control of the number, density and height arrangement of needles in the microneedle array. It does not require the control of the above parameters through the manufacturing process of the three-dimensional non-planar microneedle array, which enhances the practicality of the technology and reduces the cost.

[0054] (3) Through the synergistic effect of the lower ejector rod, the limiting spring, the upper ejector rod, and the loading spring, the present invention can enable the microneedle to quickly penetrate the skin and then quickly detach from the skin, which can effectively reduce the pain of the acupuncture recipient.

[0055] (4) The present invention can achieve comprehensive control of the microneedle insertion speed by adjusting the spring stiffness and spring compression according to the different target objects;

[0056] (5) The present invention can control the insertion depth by increasing or decreasing the height of the positioning shoulder of the insertion depth adjustment piece, and provides physical safety protection for the needle application process;

[0057] (6) The present invention adopts a modular design, and each component can be easily disassembled and replaced, which improves the convenience of use and maintenance and reduces costs. Attached Figure Description

[0058] Figure 1 This is an exploded view of the structure of the present invention;

[0059] Figure 2 Schematic diagram of a mounting plate for a microneedle array;

[0060] Figure 3 Schematic diagram of a sheet-like microneedle array substrate;

[0061] Figure 4 This is a schematic diagram of the positioning spacer;

[0062] Figure 5 This is a schematic diagram of the insertion depth adjustment piece;

[0063] Figure 6 This is a schematic diagram of the lower end of the clip;

[0064] Figure 7 This is a schematic diagram of the lower ejection lever;

[0065] Figure 8 Schematic diagram of the limit spring clamping bolt;

[0066] Figure 9 This is a schematic diagram of the casing;

[0067] Figure 10 Diagram showing the installation of the clip for the trigger switch;

[0068] Figure 11 This is a schematic diagram of the trigger switch;

[0069] Figure 12 This is a schematic diagram of the loading header;

[0070] Figure 13 This is a schematic diagram of the upper ejection lever;

[0071] Figure 14 This is a schematic diagram of the sliding guide head for the upper ejection rod;

[0072] Figure 15 Diagram of the handle for applying force;

[0073] Figure 16Figure 1 shows the front view (Figure 1a) and cross-sectional view (Figure 1b) of the AA section of the present invention.

[0074] Figure 17 Figure 1 shows the front view (Figure 1a) and cross-sectional view (Figure 1b) of the BB section of the present invention.

[0075] Figure 18 This is a perspective view of the present invention (in an uncharged state);

[0076] Figure 19 This is a three-dimensional view of the present invention (in a state of charging and waiting to apply the needle);

[0077] In the diagram: 1. Microneedle array mounting plate; 2. Sheet-shaped microneedle array substrate; 3. Positioning spacer; 4. Insertion depth adjustment plate; 5. Lower end clamp; 6. Lower ejector rod; 7. Limiting spring; 8. Limiting spring clamping pad; 9. Limiting spring clamping bolt; 10. Housing; 11. Trigger switch mounting buckle; 12. Trigger switch reset spring; 13. Trigger switch; 14. Loading head; 15. Loading spring clamping pad; 16. Loading spring; 17. Upper ejector rod; 18. Upper ejector rod sliding guide head; 19. Force application handle.

[0078] 1-1 Long strip groove; 1-2 First positioning hole; 1-3 First positioning shoulder; 2-1 Second positioning hole; 2-2 Microneedle body; 3-1 Third positioning hole; 4-1 Upper long side strip; 4-2 Second positioning shoulder; 5-1 Internal threaded hole; 5-2 First square slide; 5-3 Rectangular through hole; 5-4 First threaded hole; 6-1 Second threaded hole; 6-2 Flange; 6-3 Fourth positioning hole; 9-1 Socket headstock countersunk hole; 9-2 Columnar bolt; 10-1 Cylindrical cavity; 10-2 Ring 10-3 Limiting blind hole, 10-4 External thread; 11-1 Arc structure, 11-2 Fin, 11-3 Fifth positioning hole; 13-1 Sixth positioning hole, 13-2 Clamp, 13-3 Third threaded hole; 14-1 Fourth threaded hole, 14-2 Hemispherical crown pressure head; 17-1 First threaded post, 17-2 Seventh limiting hole, 17-3 Second threaded post; 18-1 Second square slide, 18-2 External thread; 19-1 Handle, 19-2 Fifth threaded hole. Detailed Implementation

[0079] The embodiments of this invention are only used to illustrate and explain the technical solutions of this invention and are not intended to limit it. Although the invention has been described in detail with reference to preferred embodiments, those skilled in the art should understand that modifications or equivalent substitutions can be made to the technical solutions of the invention without departing from the spirit and scope of the technical solutions of this invention, and all such modifications and substitutions should be covered within the scope of the claims of this invention.

[0080] The present invention provides a microneedle array clamping and insertion assist device with adjustable insertion depth and force, the overall structure of which is shown in the exploded view below. Figure 1 As shown.

[0081] The microneedle array mounting plate 1 has the following shape: Figure 2 As shown, the mounting plate is made of metal materials, specifically stainless steel in this embodiment. The upper end of the mounting plate has a tapered structure to reduce volume and weight. The upper part of the microneedle array mounting plate 1 has a long, narrow slot 1-1, which engages with the fourth positioning hole 6-3 on the bottom flange 6-2 of the lower ejector rod 6 to mount and fix the microneedle array mounting plate 1 onto the lower ejector rod 6. The long, narrow design facilitates position adjustment and reduces the positional and dimensional accuracy requirements of the positioning holes 6-2 and 6-3 at the bottom of the lower ejector rod 6. The lower part of the microneedle array mounting plate 1 has four first positioning holes 1-2, corresponding one-to-one with the second positioning hole 2-1 on the sheet-like microneedle array substrate 2 and the third positioning hole 3-1 on the positioning spacer 3. The sheet-like microneedle array substrate 2 and the positioning spacer 3 are fixed to the microneedle array mounting plate 1 using bolts. The four first positioning through holes 1-2 are arranged symmetrically on the left and right, and the center line forms an isosceles trapezoid, which can better restrict the movement freedom of the sheet-like microneedle array substrate 2; the lower end of the microneedle array mounting plate 1 is provided with first positioning shoulders 1-3 on both sides, which are used in conjunction with the insertion depth adjustment piece 4 to realize the physical limitation of the microneedle insertion depth.

[0082] The sheet-like microneedle array substrate 2 is made of a metallic material; in this embodiment, stainless steel is used. It has an overall rectangular sheet-like structure, such as... Figure 3 As shown, there are four second positioning holes 2-1 in the middle, which correspond one-to-one with the four first positioning through holes 1-2 on the microneedle array mounting plate 1 and the third positioning hole 3-1 on the positioning spacer 3; a certain number of microneedle bodies 2-2 are processed on the lower edge of the sheet-like microneedle array substrate 2 for piercing the skin, and the size, number and arrangement of the microneedle bodies 2-2 can be flexibly adjusted as needed.

[0083] The positioning spacer 3 can be made of metal or polymer materials; in this embodiment, stainless steel is used. The positioning spacer 3 has a rectangular sheet structure overall, such as... Figure 4 As shown, there are four third positioning holes 3-1 in the middle, which correspond one-to-one with the four first positioning through holes 1-2 on the microneedle array mounting plate 1 and the second positioning holes 2-1 on the sheet-like microneedle array substrate 2.

[0084] Furthermore, the microneedle array mounting plate 1, the sheet-like microneedle array substrate 2, and the positioning spacers 3 are installed as follows: a microneedle array mounting plate 1 is placed in the middle, and the sheet-like microneedle array substrate 2 and the positioning spacers 3 are placed alternately on both sides. After installation, bolts are used to fix it through the positioning holes, so that the sheet-like microneedle array becomes a three-dimensional microneedle array. The arrangement pattern of the microneedle array, such as the number of needles, density, and height distribution, can be controlled by adjusting the number of sheet-like microneedle array substrates 2, the thickness of the microneedle array mounting plate 1, the thickness and number of positioning spacers 3, and the height of the needles in the sheet-like microneedle array substrate 2, so as to achieve personalized needle application.

[0085] There are two insertion depth adjustment pieces 4, made of metal material; in this embodiment, stainless steel is used. The overall structure is hook-shaped, as shown... Figure 5 As shown, the upper long strip 4-1 can be inserted from both sides into the rectangular through holes 5-3 of the lower end clip 5 for fixation. The insertion depth is controlled to adapt to the width of the microneedle array mounting plate 1. The lower hook-shaped structure is the second positioning shoulder 4-2, which works in conjunction with the first positioning shoulder 1-3 on the microneedle array mounting plate 1 to achieve physical limitation on the microneedle insertion depth.

[0086] The lower end latch 5 is used to connect the housing 10 and the insertion depth adjustment piece 4, and also provides a sliding channel for the lower ejection rod 6; the lower end latch 5 is made of metal material, and in this embodiment, stainless steel is used. The whole is a hollow cylinder, such as... Figure 6 As shown, the cylinder is divided into an upper and a lower section along its axial direction. The upper section has an internal threaded hole 5-1 for connection and fixation with the external thread 10-4 at the lower end of the housing 10. The lower section has a first square slide 5-2 in the middle of its interior. The side length of the hole is smaller than the inner diameter of the threaded hole 5-1, providing an axial sliding channel for the lower ejector rod 6. The square design also prevents the lower ejector rod 6 from rotating circumferentially. The lower end of the lower end clamp 5 has a rectangular through hole 5-3 perpendicular to the axis and passing through the axis. The upper long side strip 4-1 of the insertion depth adjustment piece 4 is placed in this rectangular through hole. One threaded hole 5-4 is provided on one side of the lower end clamp 5 at a position corresponding to the rectangular through hole 5-3 near the edge, so that the upper long side strip 4-1 of the insertion depth adjustment piece 4 can be fixed with bolts.

[0087] Furthermore, the specific cooperation between the lower end clamp 5 and the insertion depth adjustment piece 4 is as follows: The upper long strip 4-1 of the insertion depth adjustment piece 4 is inserted into the rectangular through hole 5-3 on one side of the lower end clamp 5. The insertion depth is adjusted according to the width of the microneedle array mounting plate 1, ensuring a tight fit between the first positioning shoulder 1-3 of the microneedle array mounting plate 1 and the second positioning shoulder 4-2 of the insertion depth adjustment piece 4. Then, a bolt is used to press and fix the insertion depth adjustment piece 4 through the first threaded hole 5-4. The installation and use method for the other side of the insertion depth adjustment piece 4 is the same.

[0088] Furthermore, the specific cooperation between the microneedle array mounting plate 1 and the insertion depth adjustment plate 4 is as follows: When performing microneedle insertion, the first positioning shoulder 1-3 can contact the second positioning shoulder 4-2 of the insertion depth adjustment plate 4, restricting the microneedle from continuing to insert downwards, thereby accurately controlling the insertion depth of the microneedle and protecting the inserted object. The physical control of the insertion depth can be achieved by adjusting the height of the first positioning shoulder 1-3 and the thickness of the second positioning shoulder 4-2.

[0089] The lower ejection rod 6 is made of metal, specifically stainless steel in this embodiment. The main body is a long rod with a square cross-section, such as... Figure 7 As shown, the upper end has a second threaded hole 6-1 for use with the limit spring clamping bolt 9. The material at the lower end is removed on one side, and the remaining part forms a thinner flange 6-2, on which a fourth positioning hole 6-3 is provided.

[0090] Furthermore, the installation of the lower ejector rod 6 and its related components is as follows: Place the micro-needle array mounting plate 1 inside the flange 6-2 of the lower ejector rod 6, aligning the fourth positioning hole 6-3 with the elongated slot 1-1. After adjusting the position, fix it with bolts. Insert the upper end of the lower ejector rod 6 through the lower end of the lower end clamp 5 along the first square slide 5-2. Then, slide the limiting spring 7 down from the upper end of the lower ejector rod 6. Next, press the limiting spring clamping washer 8 and the limiting spring clamping bolt 9 onto the limiting spring 7 in sequence. Finally, screw the limiting spring clamping bolt 9 into the second threaded hole 6-1 to complete the installation.

[0091] Furthermore, the limiting spring 7 is a metal spring used to axially limit the lower ejector rod 6 and the microneedle array mounting plate 1 connected thereto to a certain extent. The stiffness should not be too large, but it should ensure that when the upper ejector rod 17 is lifted (in the state of charging and waiting to apply needles), there is a certain distance between the microneedle substrate 2 and the second positioning shoulder 4-2 of the insertion depth adjustment plate 4, so as to ensure that the microneedle substrate 2 has downward space to accelerate when the upper ejector rod 17 strikes the lower ejector rod 6 (in the state of applying needles). The inner diameter of the limiting spring 7 should be larger than the cross-sectional size of the lower ejector rod 6 so that the latter can be fitted in, but the outer diameter should be smaller than the cross-sectional size of the lower end of the lower end clamp 5 along the first square slide 5-2 to prevent it from sliding out of the first square slide 5-2.

[0092] Furthermore, the limiting spring clamping washer 8 is made of metal, specifically stainless steel in this embodiment. Its inner diameter is larger than the outer diameter of the limiting spring clamping bolt 9, but smaller than the outer diameter of the limiting spring clamping bolt 9 nut and the inner diameter of the limiting spring 7.

[0093] Furthermore, the limiting spring clamping bolt 9 is made of metal; in this embodiment, stainless steel is used. Its shape and structure are as follows: Figure 8 As shown, the upper end is a round nut, and the end of the nut is provided with an internal hexagon countersunk hole 9-1. In addition to facilitating fastening installation, the internal hexagon countersunk hole is also used in conjunction with the loading head 14 to make the loading force as far along the axis of the loading rod as possible. The lower end of the limiting spring clamping bolt 9 is a columnar bolt 9-2, which is used in conjunction with the second threaded hole 6-1 at the upper end of the lower ejector rod 6.

[0094] The shell 10 is made of metal material, and in this embodiment, stainless steel is used. The main body is a hollow cylindrical structure, such as... Figure 9 As shown, the interior is a cylindrical cavity 10-1. The lower ejector rod 6, limiting spring 7, limiting spring clamping washer 8, limiting spring clamping bolt 9, loading head 14, loading spring clamping washer 15, loading spring 16, and upper ejector rod 17 are all located within the cylindrical cavity 10-1. The lower outer wall of the housing 10 is provided with external threads, which cooperate with the internal threaded hole 5-1 of the lower end clamp 5, thereby connecting the lower end clamp 5 to the housing 10. The cylindrical cavity of the housing 10... The upper inner wall of cavity 10-1 is threaded for use with the external thread of the upper ejector rod sliding guide head 18, thereby connecting the upper ejector rod sliding guide head 18 to the housing 10; the outer wall near the upper end of the housing 10 is provided with an annular limiting groove 10-2 for limiting the installation of the trigger switch mounting buckle 11; the housing 10 is provided with two symmetrically arranged limiting blind holes 10-3 at the middle position for placing the trigger switch reset spring 12.

[0095] Furthermore, the housing 10 is inserted from the lower ejector rod 6 and screwed into the lower end clamp 5.

[0096] The trigger switch mounting clip 11 is made of metal, specifically stainless steel in this embodiment. There are two clips, and the overall structure is a semi-circular ring-shaped band with fins on both sides, as shown below. Figure 10 As shown. The trigger switch mounting buckle 11 has an arc structure 11-1 in the middle, and fins 11-2 on both sides. A fifth positioning hole 11-3 is provided in the middle of the fins.

[0097] The trigger switch reset spring 12 is a metal spring, which is used in conjunction with the limiting blind hole 10-3 on the housing 10. The outer diameter of the spring is slightly smaller than the inner diameter of the limiting blind hole 10-3.

[0098] The trigger switch 13 is made of metal, specifically stainless steel in this embodiment. There are two of them, and their overall shape is irregular; their front view resembles a "bird," as shown below. Figure 11 As shown. The bird has a sixth positioning hole 13-1 in the middle of its body, a locking mouth 13-2 in the upper beak, and a third threaded hole 13-3 on the side of the lower tail.

[0099] The loading head 14 is made of metal material; in this embodiment, stainless steel is used. It is a nut with an overall hemispherical crown shape, such as... Figure 12 As shown, its upper end is the fourth threaded hole 14-1, which is connected to the second threaded post 17-3 of the upper ejector rod 17; the lower end is the hemispherical crown pressure head 14-2, which is used to strike the limit spring clamping bolt 9.

[0100] The loading spring compression pad 15 is made of metal material, and stainless steel is used in this embodiment.

[0101] The loading spring 16 is a metal spring, and its stiffness is greater than that of the limiting spring 7.

[0102] The upper ejection rod 17 is made of metal material, specifically stainless steel in this embodiment. It is a long rod with a square cross-section, as shown below. Figure 13 As shown. The upper end of the upper ejector rod 17 is a first threaded post 17-1, which is used to mate and connect with the lower end internal thread 19-2 of the force application handle 19; several seventh limiting holes 17-2 are symmetrically arranged on both sides of the upper ejector rod 17 near the upper end, which are used to cooperate with the upper end latch 13-2 of the trigger switch 13 to realize the graded loading and positioning of the loading spring; the lower end of the upper ejector rod 17 is a second threaded post 17-3, which is used to mate and connect with the fourth threaded hole 14-1 at the upper end of the loading head 14.

[0103] Furthermore, the installation of the upper ejector rod 17 and its related components is as follows: the loading spring clamping washer 15 and the loading head 14 are inserted into the second threaded post 17-3 of the upper ejector rod 17 and tightened; the loading spring 16 is sleeved from the upper end of the upper ejector rod 17 and then installed into the housing 10; the upper ejector rod sliding guide head 18 is sleeved from the upper end of the upper ejector rod 17 and then screwed onto the housing 10; finally, the force application handle 19 is screwed into the first threaded post 17-1 of the upper ejector rod 17.

[0104] Furthermore, the upper ejection rod sliding guide head 18 is made of metal material and is an integral nut with a square through hole inside, that is, it is provided with a second square slide 18-1 inside, for the ejection rod 17 to slide and restrict its rotation; it is provided with a thread 18-2 on the outside, which is connected to the thread on the inner wall of the upper end of the cylindrical cavity 10-1 on the housing 10.

[0105] Furthermore, the force-applying handle 19 is made of metal and is T-shaped for applying force. The upper part has a long grip 19-1 for easy hand gripping; the lower end has a fifth threaded hole 19-2 for connecting with the first threaded post 17-1 of the upper ejection rod 17.

[0106] The latch 13-2 of the trigger switch 13 is always pressed against the two side walls of the upper ejector rod 17 under the elastic force of the trigger switch reset spring 12. According to the need for needle application, the latch 13-2 of the trigger switch 13 is engaged in the seventh limiting hole 17-2 at the corresponding position on the two side walls of the upper ejector rod 17. At this time, the force application handle 19 can be released, and the latch 13-2 engaged in the seventh limiting hole 17-2 will restrict the downward return movement of the upper ejector rod 17. It should be noted that the lower the engagement position of the seventh limiting hole 17-2, the more severely the loading spring 16 is compressed, the greater the elastic restoring force of the spring, and the faster the insertion speed of the microneedle array. If the spring restoring force provided by the seventh limiting hole 17-2 at the bottom of the latch 13-2 is still insufficient, a loading spring 16 with greater stiffness can be selected; conversely, if the spring restoring force provided by the seventh limiting hole 17-2 at the top of the latch 13-2 is still too large, a loading spring 16 with less stiffness can be selected. In this embodiment, the latch 13-2 is embedded in the fourth seventh limiting hole 17-2 from the top, and the device structure in the applied but unactivated state is as follows. Figure 19 As shown.

[0107] S4: After necessary disinfection of the acupuncture site, hold the entire device with one hand, with the second positioning shoulder 4-2 of the insertion depth adjustment plate 4 against the skin of the acupuncture site, and try to make the entire device perpendicular to the acupuncture site. At this time, the microneedle array mounting plate 1, microneedle array substrate 2 and positioning spacer 3 will be in a higher position under the action of the limiting spring 7 and will not contact the skin. After the position is adjusted, press the lower end of the trigger switch 13 on both sides with the other hand at the same time, so that the latch 13-2 slides out from the seventh limiting hole 17-2. Under the restoring force of the loading spring 16, the upper ejector rod 17 will quickly rebound, so that the loading head 14 will quickly strike the limiting spring clamping bolt 9 and the lower ejector rod 6, and finally make the microneedle array at the lower end quickly pierce the skin, forming a micron-level drug delivery channel array on the skin surface. Then, under the restoring force of the limiting spring 7, it will quickly rise and detach from the skin, completing the acupuncture operation.

[0108] S5: Remove the entire device from the injection site and apply medication to the injection site as needed to achieve transdermal drug delivery.

[0109] It should be noted that the described embodiments are only some, not all, of the embodiments of the present invention. All other embodiments obtained by those skilled in the art based on the described embodiments of the present invention without inventive effort are within the scope of protection of the present invention.

[0110] Unless otherwise defined, the technical or scientific terms used in this disclosure shall have the ordinary meaning understood by one of ordinary skill in the art to which this disclosure pertains. The terms "comprising" or "including," and similar words used in this disclosure, mean that an element or object preceding the word encompasses the elements or objects listed following the word and their equivalents, but do not exclude other elements or objects. Terms such as "upper," "lower," "left," and "right" are used only to indicate relative positional relationships; when the absolute position of the described object changes, the relative positional relationship may also change accordingly.

[0111] The above embodiments are merely illustrative of the implementation methods of the present invention, but should not be construed as limiting the scope of the present invention. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these modifications and improvements all fall within the protection scope of the present invention.

Claims

1. A microneedle array clamping and insertion assist device with adjustable insertion depth and force, characterized in that, The microneedle clamping and insertion auxiliary device includes a microneedle array mounting plate (1), a sheet-like microneedle array substrate (2), a positioning spacer (3), an insertion depth adjustment plate (4), a lower end clamp (5), a trigger switch reset spring (12), a trigger switch (13), an upper ejector rod sliding guide head (18), a force application handle (19), a housing (10), and a lower ejector rod (6), a limiting spring (7), a limiting spring compression pad (8), a limiting spring compression bolt (9), a loading head (14), an upper ejector rod (17), and a trigger switch mounting buckle (11) installed outside the housing; The upper part of the microneedle array mounting plate (1) is fitted with the lower ejector rod (6) and fixed to the lower ejector rod (6); the two sides of the microneedle array mounting plate (1) are symmetrically mounted with sheet-like microneedle array substrates (2) and positioning spacers (3); The microneedle array mounting plate (1) is also provided with a first positioning shoulder (1-3), which is used in conjunction with the insertion depth adjustment piece (4) to realize the physical limitation of the microneedle insertion depth; Two insertion depth adjustment plates (4) are provided, with the same structure, and are symmetrically installed on the lower end clamp (5) and cooperate with the first positioning shoulder (1-3) of the microneedle array mounting plate (1); the lower end clamp (5) is a hollow cylindrical structure, used to connect the housing (10) and the insertion depth adjustment plate (4), and also provides a sliding channel for the lower ejector rod (6); The upper end of the lower ejector rod (6) is inserted through the lower end of the lower end clamp (5), and the limiting spring (7) is sleeved on the upper end of the lower ejector rod (6). The limiting spring clamping washer (8) and the limiting spring clamping bolt (9) are pressed onto the limiting spring (7) in sequence, and the limiting spring clamping bolt (9) is engaged with the lower ejector rod (6) to complete the installation. The lower ejector rod (6) and the micro-needle array mounting plate (1) connected to it are axially limited by the limiting spring (7). The outer wall of the housing (10) has two symmetrically arranged blind holes in the middle position for placing the trigger switch reset spring (12); there are two trigger switch mounting buckles (11), which are symmetrically placed in the annular limiting groove (10-2) of the housing (10); two trigger switches (13) are placed between the two trigger switch mounting buckles (11), and the trigger switches (13) can rotate smoothly; The upper end of the loading head (14) is connected to the upper ejector rod (17), and the lower end is used to strike the limit spring clamping bolt (9); the upper end of the upper ejector rod (17) is connected to the lower end of the force application handle (19), and the upper ejector rod (17) is used in conjunction with the trigger switch (13) near the upper side wall to realize the graded loading and positioning of the loading spring. The lower end of the upper ejector rod (17) is paired with the upper end of the loading head (14); the upper ejector rod sliding guide head (18) is installed on the housing (10); the force application handle (19) is connected to the upper ejector rod (17).

2. The microneedle array clamping and insertion assist device with adjustable insertion depth and force according to claim 1, characterized in that, In the microneedle array clamping and insertion auxiliary device: The microneedle array mounting plate (1) is made of metal and has a plate-like structure with a tapered upper end. The upper part of the microneedle array mounting plate (1) is provided with a long strip groove (1-1), which is used in conjunction with the fourth positioning hole (6-3) on the bottom flange (6-2) of the lower ejector rod (6) to install and fix the microneedle array mounting plate (1) onto the lower ejector rod (6). The lower part of the microneedle array mounting plate (1) is provided with four first positioning holes (1-2), which correspond to the second positioning hole (2-1) on the sheet-like microneedle array substrate (2) and the third positioning hole (3-1) on the positioning spacer (3). The lower ends of the microneedle array mounting plate (1) are provided with first positioning shoulders (1-3), which are used in conjunction with the insertion depth adjustment piece (4) to achieve physical limitation of the microneedle insertion depth. The sheet-like microneedle array substrate (2) is made of metal material and has a rectangular sheet structure with four second positioning holes (2-1) in the middle; a certain number of microneedle bodies (2-2) are processed on the lower edge of the sheet-like microneedle array substrate (2), and their size, number and arrangement can be adjusted as needed; The positioning spacer (3) is made of metal or polymer material and has a rectangular sheet structure with four third positioning holes (3-1) in the middle. The spacing distance of the sheet microneedle array can be adjusted by adjusting the thickness of the positioning spacer (3) or the number of positioning spacers (3) between the two microneedle array substrates (2). Microneedle bodies (2-2) are processed on the lower edge of the sheet-like microneedle array substrate (2). After assembly, multiple sheet-like microneedle arrays become a three-dimensional microneedle array. The spacing distance of the sheet-like microneedle array is controlled by adjusting the thickness of the positioning spacer (3) or the number of positioning spacers (3) between two microneedle array substrates 2. The spacing between each needle body (2-2) on the sheet-like microneedle array is determined during processing, thereby realizing the control of the number and arrangement of needle bodies in the three-dimensional microneedle array.

3. The microneedle array clamping and insertion assist device with adjustable insertion depth and force according to claim 2, characterized in that, In the microneedle array clamping and insertion auxiliary device: There are two insertion depth adjustment plates (4), which are made of metal and have a hook-shaped structure. The upper long strip (4-1) is inserted into the rectangular through hole (5-3) of the lower end clip (5) from both sides for fixation. The insertion depth is controlled to match the width of the microneedle array mounting plate (1). The hook-shaped structure at the lower end is the second positioning shoulder (4-2), which works in conjunction with the first positioning shoulder (1-3) on the microneedle array mounting plate (1) to achieve physical limitation on the insertion depth of the microneedle. The lower end clamp (5) is made of metal and is a hollow cylinder. It is divided into an upper end and a lower end along the axial direction of the cylinder. The upper end is provided with an internal threaded hole (5-1) for connection and fixation with the external thread (10-4) at the lower end of the housing (10). The lower end structure is provided with a first square slide (5-2) in the middle position. The side length of the square slide is smaller than the inner diameter of the internal threaded hole (5-1), which provides an axial sliding channel for the lower ejection rod (6). At the same time, the square design can prevent the lower ejection. The rod (6) rotates circumferentially; the lower end of the lower end of the clamp (5) is perpendicular to the axis and has a rectangular through hole (5-3) through the axis, and the upper long side strip (4-1) of the insertion depth adjustment piece (4) is placed in this rectangular through hole (5-3); the lower end of the clamp (5) is provided with a first threaded hole (5-4) at the position corresponding to the rectangular through hole (5-3) near the edge, for fixing the upper long side strip (4-1) of the insertion depth adjustment piece (4) by bolts; The lower ejection rod (6) is made of metal material. The main body is a long rod with a square cross section. The upper end is provided with a second threaded hole (6-1) for use with the limit spring clamping bolt (9). The material at the lower end is removed on one side, and the remaining part forms a thinner flange (6-2). A fourth positioning hole (6-3) is provided on the flange.

4. The microneedle array clamping and insertion assist device with adjustable insertion depth and force according to claim 3, characterized in that, In the microneedle array clamping and insertion auxiliary device: The limiting spring (7) is a metal spring used to axially limit the lower ejector rod (6) and the micro-needle array mounting plate (1) connected to it; the inner diameter of the limiting spring (7) is larger than the cross-sectional size of the lower ejector rod (6) so that the latter can be fitted in, but the outer diameter is smaller than the cross-sectional size of the lower end of the lower end clamp (5) along the first square slide (5-2) to prevent it from sliding out of the first square slide (5-2); The limiting spring clamping washer (8) is made of metal, and its inner diameter is larger than the outer diameter of the screw of the limiting spring clamping bolt (9), but smaller than the outer diameter of the nut of the limiting spring clamping bolt (9) and the inner diameter of the limiting spring (7); The limiting spring clamping bolt (9) is made of metal. The upper end is a round nut with an internal hexagon countersunk hole (9-1) at the end of the nut for fastening and installation. It is used in conjunction with the loading head (14) to make the loading force along the axis of the loading rod. The lower end of the limiting spring clamping bolt (9) is a columnar bolt (9-2) which is used in conjunction with the second threaded hole (6-1) at the upper end of the lower ejector rod (6).

5. The microneedle array clamping and insertion assist device with adjustable insertion depth and force according to claim 4, characterized in that, In the microneedle array clamping and insertion auxiliary device: The main body of the shell (10) is a hollow cylindrical structure made of metal material. Its interior is a cylindrical cavity (10-1). The lower ejector rod (6), the limiting spring (7), the limiting spring clamping washer (8), the limiting spring clamping bolt (9), the loading head (14), the loading spring clamping washer (15), the loading spring (16), and the upper ejector rod (17) are all located in the cylindrical cavity (10-1). The lower outer wall of the shell (10) is provided with an external thread (10-4), which connects with the inner thread of the lower end clamp (5). The threaded hole (5-1) is used in conjunction with the upper inner wall of the cylindrical cavity (10-1) of the housing (10), which is used to cooperate with the external thread of the upper ejector sliding guide head (18); the outer wall near the upper end of the housing (10) is provided with an annular limiting groove (10-2), which is used to limit the installation of the trigger switch mounting buckle (11); the housing (10) is provided with two symmetrically arranged limiting blind holes (10-3) in the middle position, which are used to place the trigger switch reset spring (12); The trigger switch reset spring (12) is a metal spring, which is used in conjunction with the limiting blind hole (10-3) on the housing (10). The outer diameter of the spring is smaller than the inner diameter of the limiting blind hole (10-3). The trigger switch mounting clip (11) is made of metal material. There are two clips, which are used in pairs. The whole clip is a semi-circular ring-shaped structure with fins on both sides. The trigger switch mounting clip (11) has an arc structure (11-1) in the middle and fins (11-2) on both sides. A fifth positioning hole (11-3) is provided in the middle of the fins. The arc structure (11-1) is used to install the trigger switch mounting clip (11) onto the annular limiting groove (10-2) to ensure that the trigger switch mounting clip (11) is axially limited. The fins (11-2) are used to set the fifth positioning hole (11-3) on them. The fifth positioning hole (11-3) is used to place the clamping bolt. The bolt is used to clamp the fins (11-2) on both sides, so that the trigger switch mounting clip (11) is pressed into the annular limiting groove (10-2) to achieve fixation.

6. The microneedle array clamping and insertion assist device with adjustable insertion depth and force according to claim 5, characterized in that, The trigger switch (13) is made of metal and consists of two units. The overall shape is irregular, resembling a bird in its front view. A sixth positioning hole (13-1) is located in the middle of the bird's body, a latch (13-2) is located on the upper part of the bird's beak, and a third threaded hole (13-3) is located on the side of the lower part of the bird's tail. The sixth positioning hole (13-1) is used for inserting bolts to press against the fins (11-2). The outer diameter of the bolt is smaller than that of the sixth positioning hole (13-1). Inner diameter; the thickness of the trigger switch (13) is less than the distance between the fin (11-2) of the trigger switch mounting buckle (11) and the other fin (11-2), ensuring that the trigger switch (13) can rotate freely around the bolt; the latch (13-2) is used to engage with the seventh limiting hole (17-2) of the upper ejector rod (17) to temporarily limit the upper ejector rod (17); the third threaded hole (13-3) is used to insert the bolt to fix the trigger switch reset spring (12).

7. The microneedle array clamping and insertion assist device with adjustable insertion depth and force according to claim 6, characterized in that, In the microneedle array clamping and insertion auxiliary device: The loading head (14) is made of metal material and is a hemispherical nut. Its upper end is a fourth threaded hole (14-1), which is connected to the second threaded post (17-3) of the upper ejector rod (17). The lower end is a hemispherical pressure head (14-2), which is used to strike the limit spring clamping bolt (9). The loading spring clamping pad (15) is made of metal material and is a hollow circular piece; it is placed between the loading head (14) and the loading spring (16); The loading spring (16) is a metal spring, and its stiffness is greater than that of the limiting spring (7). The upper ejector rod (17) is made of metal and is a long rod with a square cross section. The upper end of the upper ejector rod (17) is a first threaded post (17-1), which is used to match and connect with the lower end internal thread (19-2) of the force application handle (19). Several seventh limiting holes (17-2) are symmetrically arranged on the two side walls near the upper end of the upper ejector rod (17), which are used to cooperate with the upper end latch (13-2) of the trigger switch (13) to realize the graded loading and positioning of the loading spring. The lower end of the upper ejector rod (17) is a second threaded post (17-3), which is used to match and connect with the fourth threaded hole (14-1) at the upper end of the loading head (14). The upper ejection rod sliding guide head (18) is made of metal material and has a second square slide (18-1) inside for the ejection rod 17 to slide and restrict its rotation; it has a thread (18-2) on the outside, which is connected to the thread on the inner wall of the upper end of the cylindrical cavity (10-1) on the housing (10).

8. The microneedle array clamping and insertion assist device with adjustable insertion depth and force according to claim 7, characterized in that, After the two trigger switch mounting clips (11) are installed and tightened, the distance between the two fins (11-2) is greater than the thickness of the trigger switch (13), and the inner diameter of the sixth positioning hole (13-1) on the trigger switch (13) is greater than the inner diameter of the fifth positioning hole (11-3) on the trigger switch mounting clips (11), so as to ensure that the trigger switch (13) can rotate smoothly.

9. A method of using the microneedle array clamping and insertion assist device with adjustable insertion depth and force as described in any one of claims 1-8, characterized in that, Includes the following steps: The first step is to control the size, quantity, and arrangement of the microneedle array; Determine the size, quantity, and arrangement of the microneedles in the microneedle array, select appropriate microneedle array mounting plates (1), microneedle array substrates (2), and positioning spacers (3), install and fix them, and then disinfect them. The second step is to adjust the insertion depth; According to the requirements, select a suitable insertion depth adjustment piece (4). The insertion depth is equal to the depth of the first positioning shoulder (1-3) of the microneedle array mounting plate (1) plus the height of the microneedle body (2-2) on the sheet microneedle array substrate (2) minus the height of the second positioning shoulder (4-2) of the insertion depth adjustment piece (4). After selection, fix the insertion depth adjustment piece (4) in the rectangular through hole (5-3) of the lower end clamp (5). The third step is to apply the loading force; Fix the housing (10), and then pull the handle (19) upward forcefully, so that the upper ejector rod (17) moves upward along the upper ejector rod sliding guide head (18), and the loading spring (16) is compressed and stored; during the lifting process, the latches (13-2) of the trigger switches (13) on both sides are always pressed against the two side walls of the upper ejector rod (17) under the elastic force of the trigger switch reset spring (12); According to the requirements, make the latch (13-2) of the trigger switch (13) engage in the seventh limiting hole (17-2) at the corresponding position on both sides of the upper ejector rod (17). At this time, release the force handle (19), and the latch (13-2) engaged in the seventh limiting hole (17-2) will restrict the downward return movement of the upper ejector rod (17). Step four, operation; First, adjust the position, disinfect the acupuncture site, fix the entire device, and use the second positioning shoulder (4-2) of the insertion depth adjustment piece (4) to hold the operation site, and make the entire device perpendicular to the operation site. Secondly, after the position is adjusted, press the lower end of the trigger switches (13) on both sides at the same time to make the chuck (13-2) slide out from the seventh limiting hole (17-2). Under the restoring force of the loading spring (16), the upper ejector rod (17) rebounds quickly, causing the loading head (14) to quickly hit the limiting spring clamping bolt (9) and the lower ejector rod (6), and finally the microneedle array at the lower end quickly pierces the operating part, forming a micron-level drug delivery channel array on its surface. Then, under the restoring force of the limiting spring (7), it quickly rises and separates from the operating part, completing the operation.

10. The method of using the microneedle array clamping and insertion assist device with adjustable insertion depth and force according to claim 9, characterized in that, In the aforementioned usage method: In the second step, the theoretical value of the penetration depth is the upper limit, and the actual penetration depth is less than this value; In the third step, the lower the position of the seventh limiting hole (17-2) is, the more severely the loading spring (16) is compressed, the greater the elastic restoring force of the spring, and the faster the insertion speed of the microneedle array. If the spring restoring force provided by the seventh limiting hole (17-2) at the bottom of the chuck (13-2) is still insufficient, then a loading spring (16) with greater stiffness is selected. Conversely, if the spring restoring force provided by the seventh limiting hole (17-2) at the top of the chuck (13-2) is still large, then a loading spring (16) with less stiffness is selected.

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