Wearable painless needle belt and microfluidic infusion method thereof

Abstract

The invention relates to a wearable painless needle belt and a microfluidic infusion method thereof, and belongs to the technical field of infusion, the wearable painless needle belt comprises an elastic fixing mechanism and a medicine injection mechanism, and the medicine injection mechanism comprises a protective shell and a medicine pushing assembly slidably arranged in the protective shell; the medicine pushing assembly is provided with a needle core piston, a first powerful magnetic plate and a deflation pipe, the protective shell is provided with an injection container matched with the needle core piston, a pressure relief device and a second powerful magnetic plate, and the output end of the injection container is communicated with a painless needle set used for puncturing the skin. The micro-fluidic infusion method comprises the steps of system initialization, flow parameter setting, exhausting, wearing and puncturing, magnetic drive control infusion and recovery and sterilization, and by establishing a relational expression between the movement speed v of a needle core piston and the opening and closing cross section area Av of a pipe valve, the flow speed of medicine is accurately controlled, and personalized and accurate medicine administration is achieved.

Description

Technical Field

[0001] The present invention relates to the field of infusion technology, and in particular to a wearable painless needle belt and a microfluidic infusion method thereof. Background Art

[0002] Since the advent of subcutaneous syringes in the 19th century, traditional drug injection technology has been based on the basic principle of invasive metal needle puncture. Although modern medicine has made progress in reducing puncture resistance, such as improving needle bevel design and surface lubrication technology, it still essentially uses the invasive physical puncture mode.

[0003] Currently, commonly used intramuscular and intravenous injection devices in clinical practice have significant drawbacks. First, the rigid needle, with a diameter of 0.3-3 mm and a length of 8-40 mm, creates a strong visual stimulus, triggering both visual and physiological fear. According to statistics, over 68% of children and 42% of adults experience injection phobia. Second, as the rigid needle penetrates the epidermis and dermis into the muscle layer, it inevitably damages nerve endings and capillary plexus, leading to the release of the pain mediator substance P. Furthermore, traditional syringes must be operated by a professional, and patients must endure the psychological pressure of passive puncture, which undoubtedly increases the patient burden. Although a small number of painless needle studies have been conducted in recent years, most of them are limited to improving the drug delivery channel, still retaining the visible needle structure, and have not addressed the issue of power supply.

[0004] More seriously, existing technology has a needle breakage probability of 0.03‰, posing a risk of residual drug residue in subcutaneous tissue. It can also cause localized accumulation of large-molecule drugs, leading to induration. Manual injections cause flow rate fluctuations, resulting in peak-to-valley differences in blood drug concentrations exceeding 300%. These inherent flaws severely restrict the development of patient-directed drug delivery, creating a significant technical bottleneck for the realization of non-invasive, intelligent drug delivery systems.

[0005] Therefore, it is necessary to provide a wearable painless needle belt and a microfluidic infusion method thereof to solve the above technical problems. Summary of the Invention

[0006] The purpose of the present invention is to provide a wearable painless needle belt and a microfluidic infusion method thereof to solve the above technical problems.

[0007] To achieve the above object, the present invention provides the following technical solutions:

[0008] A wearable painless needle belt, comprising:

[0009] The elastic fixing mechanism includes a central fixing plate of an annular structure and an elastic band. The elastic band is symmetrically fixed to the left and right sides of the central fixing plate. The elastic band is detachably attached to the skin of the human body at the injection site.

[0010] The drug injection mechanism includes a drug pushing component and a protective shell embedded in the inner periphery of the central fixed plate. The drug pushing component is slidably arranged in the inner cavity of the protective shell along the drug pushing direction. The drug pushing component and the protective shell enclose a closed drug pushing chamber. The drug pushing component is fixed with a needle core rod on the side facing the protective shell. A needle core piston is installed at the end of the needle core rod. The drug pushing component is also provided with a first strong magnetic plate and a venting pipe. The venting pipe passes through the drug pushing component and connects the drug pushing chamber with the outside air. The venting pipe is provided at one end away from the drug pushing chamber. Tube valve; the bottom of the inner cavity of the protective shell is fixedly connected to an injection container that cooperates with the needle core piston, the injection container is sleeved on the outside of the needle core piston, and the output end of the injection container is connected to a number of painless needle groups; the outer bottom surface of the protective shell is provided with a second strong magnetic plate, the second strong magnetic plate and the first strong magnetic plate are arranged in alignment along the axial direction of the protective shell to form a magnetic adsorption matching structure, the painless needle groups are equidistant and regularly arranged at the bottom of the second strong magnetic plate, and the second strong magnetic plate protrudes to puncture the skin of the human body at the injection position.

[0011] As a preferred technical solution of the present invention, the bottom of the inner cavity of the protective shell is also provided with several pressure buffers for controlling the sliding speed of the medicine pushing assembly, including a spring and a spring cup. The compression direction of the spring is set parallel to the medicine pushing direction, one end of the spring is fixedly installed on the bottom of the inner cavity of the protective shell, and the other end is sleeved on the inner side of the spring cup. The spring cup is fixed to the bottom of the inner cavity of the protective shell by several fixing ropes, and several of the fixing ropes are evenly distributed in the area around the spring. The length of the spring cup is less than the length of the spring, and the length of the spring cup is the minimum limit height of the medicine pushing chamber.

[0012] As a preferred technical solution of the present invention, the protective shell includes an inner ring, an outer ring having a length greater than that of the inner ring, a first bottom plate, and a second bottom plate. The inner diameter of the outer ring is greater than the outer diameter of the inner ring. The outer ring is coaxially nested on the outer circumference of the inner ring. The top surfaces of the two rings are flush over their entire circumferences and are fixedly connected by an annular cover plate. The bottom surface of the outer ring over its entire circumference is fixedly connected to the second bottom plate, and the bottom surface of the inner ring over its entire circumference is fixedly connected to the first bottom plate. The inner ring, the outer ring, the first bottom plate, and the second bottom plate enclose an indicator chamber having a U-shaped cross-section, and the indicator chamber is used to accommodate an indicator liquid.

[0013] The injection container is mounted on the first bottom plate, which is an elastic plate used to control the liquid level of the indicator liquid by adapting to the magnetic force changes through its own deformation. The second bottom plate is the second strong magnetic plate, and the painless needle group is equidistantly and regularly arranged at the bottom of the second strong magnetic plate.

[0014] As a preferred technical solution of the present invention, the inner ring includes a transparent material area with a width of x1 and an opaque material area with a width of S1-x1 along the circumferential direction, and the outer ring includes a transparent material area with a width of x2 and an opaque material area with a width of S2-x2 along the circumferential direction, wherein S1 and S2 are the circumferences of the inner ring and the outer ring respectively, and the circumferential position of the transparent material area with a width of x1 on the inner ring is aligned with the circumferential position of the transparent material area with a width of x2 on the outer ring to form an observation window, which is used to monitor the drug administration speed and the residual drug amount by the movement of the liquid level of the indicator liquid in the indicator chamber, and the transparent material area with a width of x2 on the outer ring is provided with a scale ruler, and the indicator liquid is one of mercury, glycerin, and silicone oil.

[0015] As a preferred technical solution of the present invention, a wristband and a wristband groove are provided on the top of the medicine pushing assembly. The wristband protrudes from the surface of the medicine pushing assembly, and the wristband groove is provided at a position corresponding to the wristband for accommodating the wristband.

[0016] As a preferred technical solution of the present invention, two elastic bands are provided, the proximal ends of the two elastic bands are fixedly connected to the left and right edges of the central fixing plate respectively, and the distal ends of the two elastic bands are respectively provided with buckles and clips, and the buckles are engaged and locked with each other, so that the elastic band forms a closed loop structure surrounding the limbs.

[0017] As a preferred technical solution of the present invention, the output end of the injection container is provided with a diverter plate, and a plurality of first through holes are opened on the diverter plate. The first through holes are connected to the painless needle group one-to-one through the diverter tube. The number of the first through holes, the diverter tube and the painless needle group is the same. The painless needle group includes a needle bundle fixing plate and a plurality of fine needles. The needle bundle fixing plate is equidistant and regularly provided with a plurality of second through holes which are the same in number as the fine needles. The fine needles are fixedly connected to the second through holes. The outer periphery of the needle bundle fixing plate is sealed with the end face of the diverter tube over its entire circumference to form a fully sealed liquid medicine channel for directionally guiding the medicine in the diverter tube to flow to the fine needle through the needle bundle fixing plate, while blocking lateral leakage.

[0018] As a preferred technical solution of the present invention, a sealing strip is provided at the contact position between the medicine pushing component and the inner wall of the protective shell, and the pipe valve is provided with a multi-speed adjustment table for use therewith, and different speeds of the multi-speed adjustment table correspond to different opening and closing degrees of the pipe valve.

[0019] The present invention provides a microfluidic infusion method for a wearable painless needle band, which is used for the wearable painless needle band. The microfluidic infusion method comprises the following steps:

[0020] S1. System initialization: After injecting the drug into the injection container, align and assemble the drug pushing assembly and the protective shell so that the needle core piston is coaxially inserted into the injection container. The relative position of the drug pushing assembly and the protective shell is adjusted to control the initial insertion depth of the needle core piston and form the initial volume of the drug pushing chamber.

[0021] S2. Flow parameter setting: adjusting the gear position of the tube valve according to the medicinal properties of the drug to control the advancement speed of the needle core piston in the injection container;

[0022] S3, exhaust: invert the drug injection mechanism, and when the drug continuously flows out of the output end of the painless needle set, it indicates that the air in the injection container has been exhausted, and then close the tube valve;

[0023] S4. Wearing and puncture: The wearable painless needle belt is buckled and pressed on the skin of the human body at the injection site, a pre-tightening force is applied to the elastic belt to make the painless needle assembly penetrate the epidermis of the skin, and the drug injection mechanism is pressed to further make the painless needle assembly penetrate the stratum corneum of the skin;

[0024] S5, magnetic drive control infusion: open the tube valve to the set gear, the magnetic adsorption force F generated between the first strong magnetic plate and the second strong magnetic plate m The drug pushing assembly is driven to slide along the drug pushing direction at a set speed v, and the needle core piston is driven to move at a set speed v in the injection container, thereby squeezing the drug in the injection container, pushing the drug into the stratum corneum of the skin, and being absorbed through the subcutaneous capillaries;

[0025] The needle core piston moves at a constant speed in the injection container, that is, the magnetic adsorption force F m The reaction force F of the pressure reducer s , the pressure difference force F between the medicine pushing chamber and the outside air p Balanced, satisfying the following relationship:

[0026] F m =F s +F p

[0027] S6. Recycling and sterilization: After the infusion is completed, the wearable painless needle belt is removed and sterilized with high-temperature steam. The pressure buffer and the medicine pushing component are reset to their initial states to complete the preparation for recycling.

[0028] As a preferred technical solution of the present invention, the magnetic adsorption force F m The following relationship is satisfied:

[0029]

[0030] Where B is the magnetic field strength, A m is the effective area of the first strong magnetic plate and the second strong magnetic plate, μ0 is the magnetic permeability of vacuum, and d is the distance between the first strong magnetic plate and the second strong magnetic plate;

[0031] The reaction force F of the pressure reducer s The following relationship is satisfied:

[0032] F s =k s ·x

[0033] Where k s is the spring constant, and x is the current compression of the spring;

[0034] The pressure difference F between the medicine pushing chamber and the outside air p The following relationship is satisfied:

[0035] F p =ΔP·A p

[0036]

[0037] Wherein, ΔP is the pressure difference between the medicine pushing chamber and the outside air, which is related to the opening and closing degree of the tube valve, and A p is the effective cross-sectional area of the needle core piston, ρ 空气 is the air density, v is the moving speed of the needle piston, C d is the flow coefficient of the opening and closing section of the pipe valve, A v is the opening and closing cross-sectional area of the pipe valve;

[0038] Combining the above relationship, we can get the uniform moving speed v of the needle core piston and the opening and closing cross-sectional area A of the pipe valve: v The relationship:

[0039]

[0040] According to the medicinal properties of different drugs, the infusion speed is divided into multiple gears, that is, by adjusting the opening and closing cross-sectional area A of the tube valve v Set the corresponding gear position of the uniform moving speed v of the needle core piston; based on the uniform moving speed v and the opening and closing cross-sectional area A of the pipe valve v The quantitative relationship formula is used to calibrate the required pipe valve opening and closing cross-sectional area A at each gear v value to realize graded control of infusion speed.

[0041] In summary, compared with the prior art, the present invention has the following beneficial effects:

[0042] This invention integrates various functional components into a compact structure that can be flexibly deployed at various injection sites on the human body, such as the arms, chest, abdomen, legs, or feet. This meets the current requirements for miniaturization, multi-site adaptability, and high portability of wearable medical devices. Furthermore, this invention eliminates the need for doctors or nurses to perform traditional injections. Power is provided by powerful magnetic plates at both ends of the wearable painless needle belt. To use, the drug is simply injected into the injection container, the drug delivery rate is adjusted using a valve, and the wearable painless needle belt is worn to initiate the injection process.

[0043] The present invention replaces the traditional single injection needle with a group of several neatly arranged and evenly distributed painless needles. Through multi-point minimally invasive punctures, the originally concentrated puncture force is effectively dispersed to multiple tiny areas, significantly reducing the stimulation and compression of nerve endings in the puncture area. Each painless needle has a small diameter and short length, thinner than a villus, and only acts on the surface of the skin. The penetration depth is limited and it is almost painless. The patient will not suffer from injuries such as punctured blood vessels or damaged nerves. The user's subjective experience is closer to "application" rather than "puncture", which greatly reduces psychological resistance.

[0044] Furthermore, the painless needles are evenly and regularly spaced at the bottom of the second strong magnetic plate. Even if a single needle breaks, it is drawn out of the skin by the strong magnetic plate, effectively avoiding the risk of the broken needle remaining in the body and ensuring patient safety. This design greatly enhances the safety of the injection process, eliminates patients' concerns about the possibility of broken needles remaining, and improves the reliability of the treatment and patient trust.

[0045] The present invention establishes the relationship between the uniform moving speed v of the needle core piston and the opening and closing cross-sectional area A of the pipe valve based on the closed-loop coupling mechanism of the pipe valve-strong magnetic plate-pressure damper. v The relationship between the two can accurately control the flow rate required for each drug, achieving personalized and precise drug delivery. Users do not need an electronic control system or complex programming, and do not rely on batteries or external energy sources, which improves safety and reduces costs. It is suitable for scenarios such as field first aid, home care, and battlefield infusion. BRIEF DESCRIPTION OF THE DRAWINGS

[0046] Figure 1 A top view of the wearable painless needle belt of the present invention;

[0047] Figure 2 A bottom view of the wearable painless needle belt of the present invention;

[0048] Figure 3 is a cross-sectional view of the wearable painless needle belt of the present invention;

[0049] Figure 4 Schematic diagram of the installation of the protective shell and the elastic fixing mechanism of the present invention;

[0050] Figure 5 is a schematic diagram of a protective shell of the present invention;

[0051] Figure 6 Schematic diagram of the medicine pushing assembly of the present invention;

[0052] Figure 7 Schematic diagram of the pressure buffer of the present invention;

[0053] Figure 8 This is a schematic diagram of the installation of the shunt piece and the painless needle set of the present invention;

[0054] Figure 9 is a schematic diagram of the painless injection set of the present invention;

[0055] Figure 10 This is a flow chart of the microfluidic infusion method of the wearable painless needle belt of the present invention;

[0056] Among them, 1-elastic fixing mechanism, 11-central fixing plate, 12-elastic band, 121-buckle, 122-clip, 2-drug injection mechanism, 21-drug pushing assembly, 211-needle core rod, 212-needle core piston, 213-deflation tube, 214-tube valve, 215-bracelet, 216 bracelet groove, 22-protective shell, 221-inner ring, 222-outer ring, 223-first bottom plate, 224-second bottom plate, 225-annular cover, 226-indicator liquid, 23-injection container, 231-diverter, 232-first through hole, 233-diverter tube, 24-pressure buffer, 241-spring, 242-spring cup, 243-fixing rope, 25-painless needle group, 251-needle bundle fixing plate, 252-fine needle, 253-second through hole, 26-drug pushing chamber. DETAILED DESCRIPTION

[0057] The following is a detailed description of the specific embodiments of the present invention in conjunction with the accompanying drawings. It should be understood that the specific embodiments given here are only used to illustrate and explain the present invention and cannot be used to limit the present invention.

[0058] like Figures 1 to 9 As shown, a wearable painless acupuncture belt of this embodiment includes:

[0059] The elastic fixing mechanism 1 includes a central fixing plate 11 of an annular structure and an elastic band 12. The elastic bands 12 are symmetrically fixed to the left and right sides of the central fixing plate 11. The elastic bands 12 are detachably attached to the skin of the human body at the injection site;

[0060] The drug injection mechanism 2 includes a drug pushing component 21 and a protective shell 22 embedded in the inner periphery of the central fixed plate 11. The drug pushing component 21 is slidably arranged in the inner cavity of the protective shell 22 along the drug pushing direction. The drug pushing component 21 and the protective shell 22 enclose a closed drug pushing chamber 26. A needle core rod 211 is fixed on the side of the drug pushing component 21 facing the protective shell 22. A needle core piston 212 is installed at the end of the needle core rod 211. The drug pushing component 21 is also provided with a first strong magnetic plate and a venting pipe 213. The venting pipe 213 passes through the drug pushing component 21 and connects the drug pushing chamber 26 with the outside air. The venting pipe 213 is away from A tube valve 214 is provided at one end of the medicine pushing chamber 26; an injection container 23 that cooperates with the needle core piston 212 is fixedly connected to the bottom of the inner cavity of the protective shell 22, and the injection container 23 is sleeved on the outside of the needle core piston 212. The output end of the injection container 23 is connected to a number of painless needle groups 25; a second strong magnetic plate is provided on the outer bottom surface of the protective shell 22, and the second strong magnetic plate and the first strong magnetic plate are arranged in alignment along the axial direction of the protective shell 22 to form a magnetic adsorption matching structure. The painless needle group 25 is equidistant and regularly arranged at the bottom of the second strong magnetic plate, and protrudes from the second strong magnetic plate to puncture the skin of the human body at the injection position.

[0061] The wearable painless needle belt of the present invention integrates various functional components into a compact structure, allowing for flexible deployment at various injection sites on the human body, such as the arms, chest, abdomen, legs, or feet. This meets current wearable medical device requirements for miniaturization, multi-site adaptability, and high portability. By replacing the elastic belt 12 with varying lengths and elastic moduli, personalized adjustments and stable fit can be achieved based on the user's body shape and injection site, enhancing wearer comfort and safety, preventing slippage or dislodging during use, and ensuring the accuracy and reliability of the injection process.

[0062] In terms of injection drive, the present invention uses the magnetic attraction between the first and second strong magnetic plates as the power source for drug injection. Compared with traditional injection mechanisms that rely on batteries, motors, or external power supplies, the present invention has a simpler structure, more stable operation, and does not require an external energy supply. It fundamentally avoids safety hazards such as leakage, short circuit, or fire caused by electrical components, thereby improving the safety and reliability of the entire system.

[0063] In terms of injection method, the wearable painless needle belt uses several neatly arranged and evenly distributed painless needle groups 25 to replace the traditional single injection needle. Through multi-point minimally invasive puncture, the originally concentrated puncture force is effectively dispersed to multiple tiny areas, significantly reducing the stimulation and pressure on the nerve endings in the puncture area, and effectively reducing tingling or discomfort. Each painless needle has a small diameter and short length, and is thinner than a villus. It only acts on the surface of the skin, has a limited penetration depth, and is almost painless. The patient will not suffer from injuries such as puncturing blood vessels or damaging nerves. The user's subjective experience is closer to "application" rather than "insertion", and the psychological resistance is lower. It is especially suitable for sensitive groups such as children and the elderly. In addition, the redundant design of multiple needles can significantly improve the injection success rate. Even if individual needles fail to puncture successfully, it will not affect the overall injection effect, avoiding the problems of repeated operation, cross infection and aggravated pain caused by puncture failure of traditional single needles; secondly, the painless needle group 25 is equidistant and regularly arranged at the bottom of the second strong magnetic plate. Even if individual fine needles 252 break, they will be sucked out of the skin by the strong magnetic plate, thereby effectively avoiding the risk of broken needles remaining in the body, ensuring the safety of the patient, greatly enhancing the safety of the injection process, eliminating the patient's concerns about broken needle residues, and improving the reliability of the treatment and the patient's sense of trust.

[0064] The present invention not only achieves a safe, comfortable and efficient personalized injection experience, but also combines the convenience of self-medication at home with the practicality of precise drug delivery in multiple clinical sites. It has a wide range of adaptable scenarios and good promotion and application value.

[0065] The bottom of the inner cavity of the protective shell 22 is also provided with several pressure buffers 24, which are used to control the sliding speed of the medicine pushing assembly 21, including a spring 241 and a spring cup 242. The compression direction of the spring 241 is set parallel to the medicine pushing direction, one end of which is fixedly installed on the bottom of the inner cavity of the protective shell 22, and the other end is sleeved on the inner side of the spring cup 242. The spring cup 242 is fixed to the bottom of the inner cavity of the protective shell 22 by several fixing ropes 243. The several fixing ropes 243 are evenly distributed in the area around the spring 241. The length of the spring cup 242 is less than the length of the spring 241. The length of the spring cup 242 is the minimum limit height of the medicine pushing chamber 26.

[0066] The first strong magnetic plate of the present invention is fixed to the drug pushing component 21, and the second strong magnetic plate is fixed to the bottom of the protective shell 22. The two magnetic plates are arranged relative to each other along the axial direction to generate a stable magnetic attraction, which serves as a continuous driving force for injecting drugs into the human body, pushing the needle core rod 211 and the needle core piston 212 to push the drugs out evenly; the pressure reducer 24 generates an elastic resistance in the opposite direction of the drug pushing direction through the spring 241, and the compression of the spring 241 increases linearly with the drug pushing process. This progressive resistance and the changing trend of the magnetic adsorption force offset each other, ensuring that the movement speed of the drug pushing component 21 remains uniform, avoiding the sudden spray of drugs caused by instantaneous acceleration, achieving flexible start-up and smooth advancement, and effectively controlling the flatness of the advancement curve; the tube valve 214 accurately adjusts the gas discharge rate in the chamber by controllably adjusting the opening and closing cross-sectional area of the tube valve 214, thereby indirectly adjusting the infusion speed, maintaining the pressure balance in the drug pushing chamber 26, and preventing the drug solution from being injected too quickly or too slowly. The strong magnetic plate, the pressure reducer 24 and the tube valve 214 cooperate with the adjustment mechanism to form a stable and uniform injection process, effectively avoiding the problem of the traditional spring 241 drive system with high initial force and low end force, and improving the constant speed and accuracy of the drug delivery process.

[0067] Among them, the spring cup 242 is fixed to the bottom of the inner cavity of the protective shell 22 by multiple fixing ropes 243, and the fixing ropes 243 are evenly distributed around the outer circumference of the spring 241, so that the spring cup 242 can evenly disperse the pressure during operation, preventing the spring 241 from deflecting or twisting during compression or rebound, ensuring that the spring 241 always moves axially, avoiding the drug pushing component 21 from getting stuck or moving poorly, thereby enhancing the stability of the system; in addition, the length of the spring cup 242 is shorter than that of the spring 241. When the spring 241 is compressed to a certain extent, the top of the spring cup 242 will contact the bottom of the inner cavity of the protective shell 22, limiting further compression of the spring 241. The length difference between the spring 241 and the spring cup 242 usually corresponds to the height of the drug liquid level in the injection container 23, ensuring that the compression amount of the spring 241 matches the change in the drug liquid level during the entire infusion process.

[0068] As a preferred embodiment of the present invention, the protective shell 22 includes an inner ring 221, an outer ring 222 having a length greater than that of the inner ring 221, a first bottom plate 223 and a second bottom plate 224. The inner diameter of the outer ring 222 is greater than the outer diameter of the inner ring 221. The outer ring 222 is coaxially nested on the outer circumference of the inner ring 221. The top surfaces of the two rings are flush over their entire circumferences and are fixedly connected by an annular cover plate 225. The bottom surface of the outer ring 222 is fixedly connected to the second bottom plate 224 over its entire circumference, and the bottom surface of the inner ring 221 is fixedly connected to the first bottom plate 223 over its entire circumference. The inner ring 221, the outer ring 222, the first bottom plate 223 and the second bottom plate 224 enclose an indicator chamber having a U-shaped cross-section, which is used to accommodate an indicator liquid 226.

[0069] The injection container 23 is installed on the first bottom plate 223. The first bottom plate 223 is an elastic plate, which is used to control the liquid level of the indicator liquid 226 by adapting to the magnetic force changes through its own deformation. The second bottom plate 224 is a second strong magnetic plate, and the painless needle group 25 is equidistant and regularly arranged at the bottom of the second strong magnetic plate.

[0070] The present invention uses the first bottom plate 223 as an elastic plate, and realizes visual monitoring of the remaining drug amount through elastic deformation and magnetic coupling. A deformable cavity structure is formed between the first bottom plate 223 and the second bottom plate 224. When the drug in the injection container 23 decreases, as the needle core piston 212 is advanced, the distance between the first strong magnetic plate and the second strong magnetic plate is shortened, and the generated magnetic adsorption force is enhanced. The enhanced magnetic adsorption force generates a vertical upward traction force on the first bottom plate 223 through the second bottom plate 224, causing the first bottom plate 223 to be stretched and deformed, resulting in an increase in the gap of the deformable cavity, so that the indicator liquid 226 between the inner ring 221 and the outer ring 222 flows back into the expanded deformable cavity under the action of negative pressure. Accordingly, the liquid level of the indicator liquid 226 becomes lower. According to the scale on the outer ring 222, the change in the liquid level position of the indicator liquid 226 can clearly reflect the remaining amount of drug.

[0071] As a preferred embodiment of the present invention, the inner ring 221 includes a transparent material area with a width of x1 and an opaque material area with a width of S1-x1 along the circumferential direction, and the outer ring 222 includes a transparent material area with a width of x2 and an opaque material area with a width of S2-x2 along the circumferential direction, wherein S1 and S2 are the circumferences of the inner ring 221 and the outer ring 222 respectively, and the circumferential position of the transparent material area with a width of x1 on the inner ring 221 and the transparent material area with a width of x2 on the outer ring 222 are aligned to form an observation window, which is used to monitor the drug administration speed and the residual drug amount by the movement of the liquid surface of the indicator liquid 226 in the indicator chamber. The transparent material area with a width of x2 on the outer ring 222 is provided with a scale, and the indicator liquid 226 is one of mercury, glycerin, and silicone oil.

[0072] The transparent material area on the inner ring 221 and the outer ring 222 forms a clear observation window, which makes it convenient for patients or medical staff to observe the speed of drug administration and the remaining amount of medicine, thereby improving the transparency and monitorability of the drug administration process; the opaque material area prevents patients from feeling uncomfortable due to seeing the syringe and medicine in the painless needle slot, thereby improving the patient's comfort.

[0073] As a preferred embodiment of the present invention, a wristband 215 and a wristband groove 216 are provided on the top of the medicine pushing component 21. The wristband 215 protrudes from the surface of the medicine pushing component 21, and the wristband groove 216 is set at a position corresponding to the wristband 215 for accommodating the wristband 215.

[0074] The design of the wristband 215 and the wristband groove 216 allows the wristband 215 to be stored when not in use, effectively preventing unnecessary collision or interference with other components during normal infusion. If the wristband 215 is pulled, blood backflow may occur; if the wristband 215 is pushed, the infusion speed may suddenly accelerate. Therefore, during normal infusion, it is advisable to store the wristband 215 in the wristband groove 216. This helps maintain the stability of the movement speed and direction of the medicine pushing assembly 21, ensuring the safety and accuracy of the infusion process.

[0075] As a preferred embodiment of the present invention, two elastic bands 12 are provided, and the proximal ends of the two elastic bands 12 are fixedly connected to the left and right edges of the central fixing plate 11 respectively, and the distal ends of the two elastic bands 12 are respectively provided with a buckle 121 and a buckle 122, which are engaged and locked with each other, so that the elastic band 12 forms a closed loop structure surrounding the limb.

[0076] As a preferred embodiment of the present invention, a diverter plate 231 is provided at the output end of the injection container 23, and a plurality of first through holes 232 are opened on the diverter plate 231. The first through holes 232 are connected to the painless needle group 25 one-to-one through the diverter tube 233. The number of the first through holes 232, the diverter tube 233 and the painless needle group 25 is the same. The painless needle group 25 includes a needle bundle fixing plate 251 and a plurality of fine needles 252. A plurality of second through holes 253, the same number as the fine needles 252, are equidistant and regularly opened on the needle bundle fixing plate 251. The fine needles 252 are fixedly inserted into the second through holes 253. The outer periphery of the needle bundle fixing plate 251 is sealed with the end face of the diverter tube 233 around its entire circumference to form a fully sealed liquid medicine channel for directionally guiding the medicine in the diverter tube 233 to flow to the fine needle 252 through the needle bundle fixing plate 251, while blocking lateral leakage.

[0077] like Figure 9 As shown, in this embodiment, there are 16 groups of painless needle groups 25, and each painless needle group 25 includes 8 fine needles 252 that are thinner than villi. The diameter of the fine needles 252 is about 50-100 μm, and the length is about 300-500 μm. The 16 groups of painless needle groups 25 have a total of 128 fine needles 252 that are equidistant and regularly arranged. The drug can be evenly injected over a larger area, reducing the injection pressure per unit area. There will be no harm to the patient such as puncturing blood vessels or damaging nerves, further reducing the patient's pain and improving the patient's comfort.

[0078] As a preferred embodiment of the present invention, a sealing strip is provided at the contact position between the medicine pushing component 21 and the inner wall of the protective shell 22, and a multi-speed adjustment table is provided on the pipe valve 214 for use therewith. Different speeds of the multi-speed adjustment table correspond to different opening and closing degrees of the pipe valve 214.

[0079] Working principle: The present invention uses a first strong magnetic plate provided on the medicine pushing component 21 and a second strong magnetic plate provided on the protective shell 22 as the infusion power source. In the initial state, the tube valve 214 is in a closed state, and the air in the medicine pushing chamber 26 cannot be discharged. Therefore, the distance between the two magnetic plates remains fixed, and each component in the medicine pushing chamber 26 remains stationary; when the tube valve 214 is opened, the air in the medicine pushing chamber 26 is controlled to be discharged at a set rate, resulting in a decrease in the air pressure in the cavity, providing a moving space for the magnetic drive, and the magnetic adsorption force becomes the active driving force, guiding the medicine pushing component 21 to slide along the medicine pushing direction. The needle core piston 212 moves in the injection container 23, squeezing the medicine in the injection container 23. The squeezed medicine flows into the stratum corneum of the skin through the painless needle group 25 and is absorbed by the subcutaneous capillaries. The speed of drug administration and the amount of residual medicine can be observed through the transparent observation window on the protective shell 22. This process will not cause dangers such as distension, swelling, etc. to the patient. During the entire injection process, the magnetic adsorption force and the reaction force of the pressure reducer 24 and the air pressure difference force are always balanced, ensuring that the needle core piston 212 can squeeze the medicine in the injection container 23 at a uniform speed, thereby achieving accurate and safe drug infusion.

[0080] like Figure 10 As shown, a microfluidic infusion method for a wearable painless needle belt in this embodiment is used for the wearable painless needle belt, and the microfluidic infusion method includes the following steps:

[0081] S1. System initialization: After injecting the drug into the injection container 23, align and assemble the drug pushing assembly 21 and the protective shell 22 so that the needle core piston 212 is coaxially inserted into the injection container 23. The relative position of the drug pushing assembly 21 and the protective shell 22 is adjusted to control the initial insertion depth of the needle core piston 212, thereby forming the initial volume of the drug pushing chamber 26.

[0082] S2. Flow parameter setting: adjusting the gear position of the tube valve 214 according to the medicinal properties of the drug to control the advancement speed of the needle core piston 212 in the injection container 23;

[0083] S3, exhaust: invert the drug injection mechanism 2, and wait until the drug continuously flows out of the output end of the painless needle assembly 25, indicating that the air in the injection container 23 is exhausted, and then close the tube valve 214;

[0084] S4. Wearing and puncture: The wearable painless needle belt is buckled and pressed against the skin of the human body at the injection site, and a pre-tightening force is applied to the elastic belt 12 to make the painless needle assembly 25 penetrate the epidermis of the skin. The drug injection mechanism 2 is pressed to further make the painless needle assembly 25 penetrate the stratum corneum of the skin;

[0085] S5, magnetic drive control infusion: open the tube valve 214 to the set gear, the magnetic attraction force F generated between the first strong magnetic plate and the second strong magnetic plate mThe drug pushing assembly 21 is driven to slide along the drug pushing direction at a set speed v, and the needle core piston 212 is driven to move at a set speed v in the injection container 23, thereby squeezing the drug in the injection container 23, pushing the drug into the stratum corneum of the skin and being absorbed through the subcutaneous capillaries;

[0086] The needle core piston 212 moves at a constant speed in the injection container 23, that is, the magnetic attraction force F m The reaction force F of the pressure reducer 24 s , the pressure difference F between the medicine pushing chamber 26 and the outside air p Balanced, satisfying the following relationship:

[0087] F m =F s +Fp

[0088] S6. Recycling and sterilization: After the infusion is completed, the wearable painless needle belt is removed and sterilized with high-temperature steam. The pressure buffer 24 and the medicine pushing component 21 are reset to the initial state to complete the preparation for recycling.

[0089] In this embodiment, different gears of the tube valve 214 are set according to the medicinal properties of the drug. When the drug needs to be slowly advanced, that is, the needle core piston 212 moves slowly within the injection container 23, the opening and closing cross-sectional area of the tube valve 214 should be adjusted to a smaller value. This limits the exhaust rate of the drug pushing chamber 26, causing the air in the drug pushing chamber 26 to flow out slowly, thereby maintaining a higher air pressure in the drug pushing chamber 26, thereby counteracting the magnetic attraction force between the strong magnetic plates. At this time, the pressure difference between the drug pushing chamber 26 and the external atmospheric pressure creates a dynamic resistance in the opposite direction of the magnetic attraction force, inhibiting the accelerated movement of the drug pushing assembly 21, thereby reducing the infusion speed.

[0090] In actual operation, after the medicine is assembled, the medicine injection mechanism 2 is first inverted and the tube valve 214 is opened. The medicine pushing component 21 is manually pushed gently until the medicine continuously flows out of the output end of the painless needle group 25, so as to ensure that the air in the injection container 23 and the painless needle group 25 is completely discharged, and then the tube valve 214 is closed. At this time, the medicine pushing chamber 26 is in a closed state. Since the air in the medicine pushing chamber 26 cannot be discharged, the magnetic adsorption force of the strong magnetic plate is not enough to overcome the reaction force and the maximum pressure difference resistance provided by the pressure buffer 24, and the medicine pushing component 21 is self-locking. At this time, each component in the medicine pushing chamber 26 remains stationary, ensuring that the medicine pushing component 21 remains stationary before the painless needle group 25 pierces the skin, effectively preventing medicine leakage or accidental injection caused by misoperation;

[0091] After the painless needle assembly 25 penetrates the stratum corneum of the skin, the tube valve 214 is opened to the set gear position, the pressure in the medicine pushing chamber 26 is transiently released, and the magnetic attraction force starts to drive the medicine pushing component 21 to start, so that the wearable painless needle belt can infuse at a preset infusion speed. During the entire infusion process, the magnetic attraction force of the strong magnetic plate, the reaction force of the pressure buffer 24, and the pressure difference between the medicine pushing chamber 26 and the outside air are balanced, ensuring that the needle core piston 212 moves at a uniform speed in the injection container 23, thereby squeezing the medicine into the painless needle assembly 25 at a uniform speed;

[0092] The spring 241 in the pressure buffer 24 provides an elastic resistance in the opposite direction of the medicine pushing direction, effectively suppressing the acceleration fluctuation of the medicine pushing component 21. Since the compression direction of the spring 241 in this embodiment is parallel to the medicine pushing direction, the elastic resistance directly acts on the movement axis of the medicine pushing component 21. As the medicine pushing process advances, the compression amount of the spring 241 increases linearly, providing a progressive resistance, which offsets the magnetic adsorption force that gradually increases due to the decrease in the distance between the magnetic plates, thereby ensuring that the infusion process always maintains a uniform speed. When the medicine pushing component 21 moves to the point where the end of the spring cup 242 abuts the medicine pushing chamber 26, a shock-free stop is achieved, avoiding drug reflux or patient discomfort caused by a sudden stop, and completing the entire infusion process.

[0093] After use, the wearable painless needle band is removed and sterilized with high-temperature steam. The pressure reducer 24 and the drug pusher assembly 21 are reset to their initial state, ready for the next use. The present invention achieves adaptive constant-rate infusion without electrical drive through the closed-loop coupling control of the tube valve 214, the strong magnetic plate, and the pressure reducer 24. Its grading mechanism can accurately match the infusion requirements of different viscosity liquids such as insulin and monoclonal antibodies. The axial pressure-relief structure and safety lock design significantly improve the reliability of clinical operation and the safety of patients. It avoids the defects of existing technologies that rely on external power supplies to provide infusion power and rely on input current to adjust the infusion rate, reducing the complexity of the power supply and control system.

[0094] As a preferred embodiment of the present invention, the magnetic adsorption force F m The following relationship is satisfied:

[0095]

[0096] Where B is the magnetic field strength, A m is the effective area of the first strong magnetic plate and the second strong magnetic plate, μ0 is the vacuum magnetic permeability, and d is the distance between the first strong magnetic plate and the second strong magnetic plate;

[0097] The reaction force F of the pressure reducer 24 s The following relationship is satisfied:

[0098] F s =k s·x

[0099] Where k s is the constant of spring 241, and x is the current compression of spring 241;

[0100] The pressure difference F between the medicine pushing chamber 26 and the outside air p The following relationship is satisfied:

[0101] F p =ΔP·A p

[0102]

[0103] Where, ΔP is the pressure difference between the medicine pushing chamber 26 and the outside air, which is related to the opening and closing degree of the tube valve 214. p is the effective cross-sectional area of the needle core piston 212, ρ 空气 is the air density, v is the moving speed of the needle core piston 212, C d A is the flow coefficient of the opening and closing section of the pipe valve 214, v is the opening and closing cross-sectional area of the pipe valve 214;

[0104] Combining the above relationship, we can get the uniform moving speed v of the needle core piston 212 and the opening and closing cross-sectional area A of the tube valve 214. v The relationship:

[0105]

[0106] According to the requirements of the medicinal properties of different drugs, the infusion speed is divided into multiple gears, that is, by adjusting the opening and closing cross-sectional area A of the tube valve 214 v Set the corresponding gear position of the uniform moving speed v of the needle core piston 212; based on the uniform moving speed v and the opening and closing cross-sectional area A of the tube valve 214 v The quantitative relationship formula is used to calibrate the opening and closing cross-sectional area A of the pipe valve 214 required for each gear position. v value to realize graded control of infusion speed.

[0107] The present invention establishes the relationship between the uniform moving speed v of the needle core piston 212 and the opening and closing cross-sectional area A of the pipe valve 214 based on the closed-loop coupling mechanism of the pipe valve 214-strong magnetic plate-pressure damper 24. v The relationship between the two can accurately control the flow rate required for each drug, achieving personalized and precise drug delivery. Users do not need an electronic control system or complex programming, and do not rely on batteries or external energy sources, which improves safety and reduces costs. It is suitable for scenarios such as field first aid, home care, and battlefield infusion. Furthermore, micro sensors and electronically controlled valves can be introduced to expand it into an intelligent, adjustable painless injection device that supports remote control and data recording.

[0108] It should be understood that the above embodiments are one or more embodiments of the present invention. There are many other embodiments and variations thereof based on the present invention. The variations and modifications made by ordinary technicians in this industry through the present invention without making groundbreaking innovations all fall within the scope of protection of the present invention.

Claims

1. A wearable painless needle belt, characterized in that include: The elastic fixing mechanism includes a central fixing plate of an annular structure and an elastic band. The elastic band is symmetrically fixed to the left and right sides of the central fixing plate. The elastic band is detachably attached to the skin of the human body at the injection site. The drug injection mechanism includes a drug pushing component and a protective shell embedded in the inner periphery of the central fixed plate. The drug pushing component is slidably arranged in the inner cavity of the protective shell along the drug pushing direction. The drug pushing component and the protective shell enclose a closed drug pushing chamber. The drug pushing component is fixed with a needle core rod on the side facing the protective shell. A needle core piston is installed at the end of the needle core rod. The drug pushing component is also provided with a first strong magnetic plate and a venting pipe. The venting pipe passes through the drug pushing component and connects the drug pushing chamber with the outside air. The venting pipe is provided at one end away from the drug pushing chamber. Tube valve; the bottom of the inner cavity of the protective shell is fixedly connected to an injection container that cooperates with the needle core piston, the injection container is sleeved on the outside of the needle core piston, and the output end of the injection container is connected to a number of painless needle groups; the outer bottom surface of the protective shell is provided with a second strong magnetic plate, the second strong magnetic plate and the first strong magnetic plate are arranged in alignment along the axial direction of the protective shell to form a magnetic adsorption matching structure, the painless needle groups are equidistant and regularly arranged at the bottom of the second strong magnetic plate, and the second strong magnetic plate protrudes to puncture the skin of the human body at the injection position.

2. The wearable painless needle belt according to claim 1, characterized in that: The bottom of the inner cavity of the protective shell is also provided with several pressure buffers for controlling the sliding speed of the medicine pushing assembly, including a spring and a spring cup. The compression direction of the spring is set parallel to the medicine pushing direction, one end of the spring is fixedly installed on the bottom of the inner cavity of the protective shell, and the other end is sleeved on the inner side of the spring cup. The spring cup is fixed to the bottom of the inner cavity of the protective shell by several fixing ropes, and several of the fixing ropes are evenly distributed in the area around the spring. The length of the spring cup is less than the length of the spring, and the length of the spring cup is the minimum limit height of the medicine pushing chamber.

3. The wearable painless acupuncture belt according to claim 1, characterized in that: The protective shell includes an inner ring, an outer ring longer than the inner ring, a first bottom plate, and a second bottom plate. The inner diameter of the outer ring is larger than the outer diameter of the inner ring. The outer ring is coaxially nested on the outer circumference of the inner ring. The top surfaces of the two rings are flush over their entire circumferences and are fixedly connected via an annular cover plate. The bottom surface of the outer ring over its entire circumference is fixedly connected to the second bottom plate. The bottom surface of the inner ring over its entire circumference is fixedly connected to the first bottom plate. The inner ring, the outer ring, the first bottom plate, and the second bottom plate enclose an indicator chamber with a U-shaped cross-section, and the indicator chamber is used to accommodate an indicator liquid. The injection container is mounted on the first bottom plate, which is an elastic plate used to control the liquid level of the indicator liquid by adapting to the magnetic force changes through its own deformation. The second bottom plate is the second strong magnetic plate, and the painless needle group is equidistantly and regularly arranged at the bottom of the second strong magnetic plate.

4. The wearable painless acupuncture belt according to claim 3, characterized in that: The inner ring includes a transparent material area with a width of x1 and an opaque material area with a width of S1-x1 along the circumferential direction, and the outer ring includes a transparent material area with a width of x2 and an opaque material area with a width of S2-x2 along the circumferential direction, wherein S1 and S2 are the circumferences of the inner ring and the outer ring respectively, and the circumferential position of the transparent material area with a width of x1 on the inner ring is aligned with the circumferential position of the transparent material area with a width of x2 on the outer ring to form an observation window, which is used to monitor the drug administration speed and the residual drug amount by the movement of the liquid level of the indicator liquid in the indicator chamber, and the transparent material area with a width of x2 on the outer ring is provided with a scale, and the indicator liquid is one of mercury, glycerin, and silicone oil.

5. The wearable painless acupuncture belt according to claim 1, characterized in that: A wristband and a wristband groove are provided on the top of the medicine pushing component. The wristband protrudes from the surface of the medicine pushing component, and the wristband groove is provided at a position corresponding to the wristband for receiving the wristband.

6. The wearable painless acupuncture belt according to claim 1, characterized in that: There are two elastic bands, the proximal ends of the two elastic bands are fixedly connected to the left and right edges of the central fixing plate respectively, and the distal ends of the two elastic bands are respectively provided with buckles and clips, and the buckles are engaged and locked with each other, so that the elastic band forms a closed loop structure surrounding the limbs.

7. The wearable painless acupuncture belt according to claim 1, characterized in that: The output end of the injection container is provided with a diverter plate, and a plurality of first through holes are opened on the diverter plate. The first through holes are connected to the painless needle group one-to-one through the diverter tube. The number of the first through holes, the diverter tube and the painless needle group is the same. The painless needle group includes a needle bundle fixing plate and a plurality of fine needles. The needle bundle fixing plate is equidistantly and regularly provided with a plurality of second through holes, the same number as the fine needles, and the fine needles are fixedly inserted into the second through holes. The outer periphery of the needle bundle fixing plate is sealed with the end face of the diverter tube around its entire circumference to form a fully sealed liquid medicine channel for directionally guiding the medicine in the diverter tube to flow to the fine needle through the needle bundle fixing plate, while blocking lateral leakage.

8. The wearable painless acupuncture belt according to claim 1, characterized in that: A sealing strip is provided at the contact position between the medicine pushing component and the inner wall of the protective shell, and a multi-speed adjustment table for use therewith is provided on the pipe valve, and different speeds of the multi-speed adjustment table correspond to different opening and closing degrees of the pipe valve.

9. A microfluidic infusion method with a wearable painless needle belt, characterized in that: For the wearable painless needle belt according to claim 2, the microfluidic infusion method comprises the following steps: S1. System initialization: After injecting the drug into the injection container, align and assemble the drug pushing assembly and the protective shell so that the needle core piston is coaxially inserted into the injection container. The relative position of the drug pushing assembly and the protective shell is adjusted to control the initial insertion depth of the needle core piston and form the initial volume of the drug pushing chamber. S2. Flow parameter setting: adjusting the gear position of the tube valve according to the medicinal properties of the drug to control the advancement speed of the needle core piston in the injection container; S3, exhaust: invert the drug injection mechanism, and when the drug continuously flows out of the output end of the painless needle set, indicating that the air in the injection container is exhausted, close the tube valve at this time; S4. Wearing and puncture: The wearable painless needle belt is buckled and pressed on the skin of the human body at the injection site, a pre-tightening force is applied to the elastic belt to make the painless needle assembly penetrate the epidermis of the skin, and the drug injection mechanism is pressed to further make the painless needle assembly penetrate the stratum corneum of the skin; S5, magnetic drive control infusion: open the tube valve to the set gear, the magnetic adsorption force F generated between the first strong magnetic plate and the second strong magnetic plate m The drug pushing assembly is driven to slide along the drug pushing direction at a set speed v, and the needle core piston is driven to move at a set speed v in the injection container, thereby squeezing the drug in the injection container, pushing the drug into the stratum corneum of the skin, and being absorbed through the subcutaneous capillaries; The needle core piston moves at a constant speed in the injection container, that is, the magnetic adsorption force F m The reaction force F of the pressure reducer s , the pressure difference force F between the medicine pushing chamber and the outside air p Balanced, satisfying the following relationship: F m =F s +F p S6. Recycling and sterilization: After the infusion is completed, the wearable painless needle belt is removed and sterilized with high-temperature steam. The pressure buffer and the medicine pushing component are reset to their initial states to complete the preparation for recycling.

10. The microfluidic infusion method of the wearable painless needle belt according to claim 9, characterized in that: The magnetic adsorption force F m The following relationship is satisfied: Where B is the magnetic field strength, A m is the effective area of the first strong magnetic plate and the second strong magnetic plate, μ0 is the magnetic permeability of vacuum, and d is the distance between the first strong magnetic plate and the second strong magnetic plate; The reaction force F of the pressure reducer s The following relationship is satisfied: F s =k s ·x Where k s is the spring constant, and x is the current compression of the spring; The pressure difference F between the medicine pushing chamber and the outside air p The following relationship is satisfied: F p =ΔP·A p Wherein, ΔP is the pressure difference between the medicine pushing chamber and the outside air, which is related to the opening and closing degree of the tube valve, and A p is the effective cross-sectional area of the needle core piston, ρ 空气 is the air density, v is the moving speed of the needle piston, C d is the flow coefficient of the opening and closing section of the pipe valve, A v is the opening and closing cross-sectional area of the pipe valve; Combining the above relationship, we can get the uniform moving speed v of the needle core piston and the opening and closing cross-sectional area A of the pipe valve: v The relationship: According to the medicinal properties of different drugs, the infusion speed is divided into multiple gears, that is, by adjusting the opening and closing cross-sectional area A of the tube valve v Set the corresponding gear position of the uniform moving speed v of the needle core piston; based on the uniform moving speed v and the opening and closing cross-sectional area A of the pipe valve v The quantitative relationship formula is used to calibrate the required pipe valve opening and closing cross-sectional area A at each gear v value to realize graded control of infusion speed.

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