A skin pricking device with a quantitative structure

Abstract

This invention discloses a skin pricking device with a quantitative structure. The method includes: constructing a cap, a quantitative chamber, micropores / capillary channels, a pricking needle, and a triggering mechanism; the cap is a cylindrical / cover-like structure with an open lower end, the lower end of which is used to conform to the skin surface; the quantitative chamber is located inside the cap and is a fixed-volume liquid storage chamber; the micropores / capillary channels connect the quantitative chamber to the lower opening of the cap; the pricking needle is located inside the cap, and the triggering mechanism controls the release of liquid and the extension of the pricking needle. This invention solves the following problems: 1. Difficulty in controlling the amount of liquid added: Operators add liquid based on experience, resulting in significant differences in liquid volume between different operators and different operations, affecting the consistency of results. 2. Reagent waste: Allergen reagents are expensive, and excessive addition causes unnecessary waste. 3. Multiple operation steps: The liquid infusion and pricking are performed in two steps, resulting in low operation efficiency and risks such as liquid drying and contamination.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more specifically, to a skin pricking device with a quantitative structure. Background Technology

[0002] Allergic diseases are prevalent chronic non-communicable diseases worldwide, encompassing various types such as allergic rhinitis, allergic asthma, atopic dermatitis, food allergies, and drug allergies. They severely impact patients' quality of life, and some acute allergic reactions can even be life-threatening. Allergen-specific testing is a core component in the diagnosis, differential diagnosis, etiological identification, and individualized treatment planning of allergic diseases. The accuracy and reliability of the test results directly determine the efficiency of clinical diagnosis and the effectiveness of treatment.

[0003] Among existing allergen detection technologies, the skin prick test has become the preferred in vivo allergen screening method for dermatology, allergy, and respiratory departments in medical institutions at all levels due to its advantages such as ease of operation, rapid detection, minimal invasiveness, moderate sensitivity and specificity, and immediate result reading. The basic principle of this test is as follows: a small amount of standardized allergen prick solution is precisely placed on the patient's skin surface. A special prick needle is used to gently prick the epidermis, allowing the trace allergen to enter the intradermal layer, inducing a local immune response. After a period of time, the size of the wheals, redness, and the degree of itching are observed to determine whether the subject is sensitized to that allergen.

[0004] The current clinical practice of performing skin prick tests still follows a traditional step-by-step approach: First, medical staff use a plastic dropper or disposable microneedle to draw allergen prick solution from a reagent bottle. Then, relying on their experience in hand control, they drop the solution onto the skin surface of pre-designated test sites such as the inner forearm or back. After the solution has been added, the prick needle is replaced, placed vertically in the center of the droplet, and gently pressed to puncture the epidermis, completing the prick test. Although this traditional approach has been used for a long time and is widely adopted, it has revealed several insurmountable technical shortcomings in long-term clinical practice and can no longer meet the needs of modern precision medicine, standardized diagnosis and treatment, and efficient utilization of medical resources.

[0005] Firstly, precise quantitative control of the amount of prick test fluid applied is difficult. Traditional dropper application relies on the operator's hand strength, angle, dropper diameter, and fluid viscosity. Significant differences in operating habits among different healthcare professionals, and even fluctuations in different applications by the same operator, lead to substantial errors in the dosage of a single application. Clinical studies have shown that non-quantitative application results in inconsistent fluid coverage and effective allergen contact at the prick site, directly causing distortions in the size of wheal reactions, frequent false positive / false negative results, and severely reducing the repeatability, comparability, and clinical reference value of test results.

[0006] Secondly, there is significant waste of high-value allergen reagents, resulting in high testing costs. Standardized allergen prick test solutions have complex production processes, scarce raw materials, and generally high unit prices. Traditional dripping methods often lead to over-dose to ensure sufficient solution, with the excess exceeding the effective dose for skin prick testing rapidly evaporating, flowing away, or being excessively absorbed by the skin, failing to participate in an effective immune response and resulting in ineffective reagent consumption. For large-scale allergen screening scenarios, the reagent waste problem is even more pronounced, significantly increasing the economic burden on medical institutions and patients.

[0007] Third, the operation is cumbersome, the detection efficiency is low, and the risk of contamination and failure is high. Traditional methods require three separate actions: aspiration, dripping, and pricking. The operation process is lengthy and time-consuming. In large-scale physical examinations or multi-allergen testing, medical staff are prone to fatigue and errors. At the same time, there is a time interval between dripping and pricking, during which the pricking solution is exposed to air and is prone to drying and concentration, as well as contamination by environmental dust or microorganisms, leading to drift in test results. The step-by-step operation also increases the probability of cross-contamination between the needle and the skin, which does not comply with aseptic operation standards.

[0008] Fourth, the equipment is scattered, making its use and management inconvenient. Traditional prick tests require multiple independent equipment such as droppers, reagent bottles, and prick needles. Preparation before use is cumbersome, and the classification and disposal of medical waste after use is complicated. The cost of using disposable equipment is high, while reusing equipment poses the risk of incomplete disinfection and cross-infection.

[0009] To address the aforementioned issues, the industry urgently needs an integrated, standardized, and quantitatively precise skin prick device that simultaneously achieves quantitative storage, controlled release, and integrated puncture of the prick solution. This would unify operational standards, improve detection accuracy, save reagent costs, and simplify clinical procedures. This invention addresses the pain points of existing technologies by providing a skin prick device with a quantitative structure through structural innovation and functional integration. This overcomes the shortcomings of traditional technologies and meets the needs of high-quality clinical diagnosis and treatment.

[0010] In general, skin prick testing is currently the most common method for allergen detection. In clinical practice, the allergen prick test solution is typically applied to the skin surface using a dropper or needle, followed by puncture with a prick needle. This method has the following problems:

[0011] 1. Difficulty in controlling the amount of liquid added: Operators add liquid based on experience, resulting in significant differences in the amount of liquid used between different operators and between different operations, which affects the consistency of results.

[0012] 2. Reagent waste: Allergen reagents are expensive, and excessive addition causes unnecessary waste.

[0013] 3. Multiple operation steps: The dripping and pricking are performed in two steps, which is inefficient and poses risks such as liquid drying and contamination.

[0014] There is currently no effective solution to the above problems. Summary of the Invention

[0015] This invention provides a skin pricking device with a quantitative structure to at least address the following issues: 1. Difficulty in controlling the amount of liquid added: Operators rely on experience to add liquid, resulting in significant differences in liquid volume between different operators and different operations, affecting the consistency of results. 2. Reagent waste: Allergen reagents are expensive, and excessive addition causes unnecessary waste. 3. Multiple operation steps: The dripping and pricking are performed in two steps, resulting in low operational efficiency and technical problems such as liquid drying and contamination.

[0016] According to one aspect of the present invention, a skin pricking device with a quantitative structure is provided, comprising a cap, a quantitative chamber, a micropore / capillary channel, a pricking needle, and a triggering mechanism; the cap is a cylindrical / cover-shaped structure with an open lower end, the lower end of which is used to conform to the skin surface; the quantitative chamber is disposed inside the cap and is a liquid storage chamber with a fixed volume; the micropore / capillary channel connects the quantitative chamber to the lower opening of the cap; the pricking needle is disposed inside the cap, and the triggering mechanism controls the release of liquid and the extension of the pricking needle.

[0017] Optionally, the quantitative chamber is a preset fixed volume chamber with a volume specification of 5μL, 10μL or 15μL, used to accurately contain the pricking fluid required for a single test.

[0018] Optionally, the micropore / capillary channel has a single-pore or multi-pore structure, and the puncture fluid is quantitatively discharged through surface tension or slight squeezing of the cap.

[0019] Optionally, the puncture needle is located at the central axis of the cap body, with the needle tip initially hidden inside the cap body, and extending out of the lower opening of the cap body to complete the puncture after being triggered.

[0020] Optionally, the triggering mechanism is an elastic pressing structure, which realizes the sequential action of first draining fluid and then pricking.

[0021] Optionally, the metering chamber may be pre-filled with puncture fluid, or the puncture fluid may be metered and filled by negative pressure aspiration.

[0022] Optionally, the lower opening of the cap is a planar annular structure for vertical sealing and fitting against the skin surface.

[0023] Optionally, the puncture needle is a disposable medical stainless steel needle body, which is integrally formed with the cap body or detachably connected.

[0024] Optionally, the elastic pressing structure includes a spring, a pressing cap, and a linkage rod. Pressing the pressing cap drives the linkage rod to complete the drainage and puncture actions in sequence.

[0025] Optionally, the device is an integrated disposable structure, with the metering chamber, micropore / capillary channel, puncture needle and triggering mechanism all integrated inside the cap.

[0026] In this embodiment of the invention, a cap body, a metering chamber, micropores / capillary channels, a needle, and a triggering mechanism are constructed. The cap body is a cylindrical / cover-like structure with an open lower end, which is used to fit the skin surface. The metering chamber is located inside the cap body and is a liquid storage chamber with a fixed volume. The micropores / capillary channels connect the metering chamber to the lower opening of the cap body. The needle is located inside the cap body. The triggering mechanism controls the liquid release and the extension of the needle, thus solving the following problems: 1. Difficulty in controlling the amount of liquid added: Operators add liquid based on experience, resulting in significant differences in the amount of liquid used between different operators and different operations, affecting the consistency of results. 2. Reagent waste: Allergen reagents are expensive, and excessive addition causes unnecessary waste. 3. Multiple operation steps: The dripping and pricking are performed in two steps, resulting in low operation efficiency and risks such as liquid drying and contamination. Attached Figure Description

[0027] The accompanying drawings, which are included to provide a further understanding of the invention and form part of this application, illustrate exemplary embodiments of the invention and, together with their description, serve to explain the invention and do not constitute an undue limitation thereof. In the drawings:

[0028] Figure 1 This is a structural diagram of a skin pricking device with a quantitative structure according to an embodiment of the present invention;

[0029] Figure 2 This is a skin pricking device with a quantitative structure according to an embodiment of the present invention.

[0030] The labels in the diagram are as follows: 1— Cap body; 2— Metering chamber; 3— Micropore / capillary channel; 4— Puncture needle; 5— Triggering mechanism; 51— Press cap; 52— Reset spring; 53— Linkage push rod; 6— Lower end opening; 7— Annular flexible pressing edge. Detailed Implementation

[0031] To enable those skilled in the art to better understand the present invention, the technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings of the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort should fall within the scope of protection of the present invention.

[0032] It should be noted that the terms "first," "second," etc., in the specification, claims, and accompanying drawings of this invention are used to distinguish similar objects and are not necessarily used to describe a specific order or sequence. It should be understood that such data can be interchanged where appropriate so that the embodiments of the invention described herein can be implemented in orders other than those illustrated or described herein. Furthermore, the terms "comprising" and "having," and any variations thereof, are intended to cover a non-exclusive inclusion; for example, a process, method, system, product, or apparatus that comprises a series of steps or units is not necessarily limited to those steps or units explicitly listed, but may include other steps or units not explicitly listed or inherent to such processes, methods, products, or apparatus.

[0033] According to an embodiment of the present invention, a method embodiment of a skin pricking device with a quantitative structure is provided. It should be noted that the steps shown in the flowchart in the accompanying drawings can be executed in a computer system such as a set of computer-executable instructions. Furthermore, although a logical order is shown in the flowchart, in some cases, the steps shown or described may be executed in a different order than that shown here.

[0034] Example 1

[0035] Figure 1 This is a structural diagram of a skin pricking device with a quantitative structure according to an embodiment of the present invention, as shown below. Figure 1 As shown, the method includes a cap body, a metering chamber, a micropore / capillary channel, a puncture needle, and a triggering mechanism; the cap body is a cylindrical / cover-shaped structure with an open lower end, the lower end of which is used to fit the skin surface; the metering chamber is located inside the cap body and is a liquid storage chamber with a fixed volume; the micropore / capillary channel connects the metering chamber to the lower opening of the cap body; the puncture needle is located inside the cap body, and the triggering mechanism controls the liquid release and the extension of the puncture needle.

[0036] Optionally, the quantitative chamber is a preset fixed volume chamber with a volume specification of 5μL, 10μL or 15μL, used to accurately contain the pricking fluid required for a single test.

[0037] Optionally, the micropore / capillary channel has a single-pore or multi-pore structure, and the puncture fluid is quantitatively discharged through surface tension or slight squeezing of the cap.

[0038] Optionally, the puncture needle is located at the central axis of the cap body, with the needle tip initially hidden inside the cap body, and extending out of the lower opening of the cap body to complete the puncture after being triggered.

[0039] Optionally, the triggering mechanism is an elastic pressing structure, which realizes the sequential action of first draining fluid and then pricking.

[0040] Optionally, the metering chamber may be pre-filled with puncture fluid, or the puncture fluid may be metered and filled by negative pressure aspiration.

[0041] Optionally, the lower opening of the cap is a planar annular structure for vertical sealing and fitting against the skin surface.

[0042] Optionally, the puncture needle is a disposable medical stainless steel needle body, which is integrally formed with the cap body or detachably connected.

[0043] Optionally, the elastic pressing structure includes a spring, a pressing cap, and a linkage rod. Pressing the pressing cap drives the linkage rod to complete the drainage and puncture actions in sequence.

[0044] Optionally, the device is an integrated disposable structure, with the metering chamber, micropore / capillary channel, puncture needle and triggering mechanism all integrated inside the cap.

[0045] As shown in Figures 1 and 2, a skin pricking device with a quantitative structure has an overall pen-like cylindrical structure, approximately 40 mm in height and 8 mm in maximum outer diameter, conforming to ergonomic hand-holding habits. The device mainly consists of a cap 1, a quantitative chamber 2, a micropore / capillary channel 3, a pricking needle 4, and a triggering mechanism 5.

[0046] The cap body 1 is injection molded from medical-grade polypropylene (PP), forming a cylindrical structure that is closed at the top and open at the bottom. A ring-shaped anti-slip knurled texture is provided in the center of the outer wall for easy gripping and positioning. The bottom of the cap body 1 has an opening 6 with a diameter of approximately 4mm, and an annular flexible pressure edge 7 is provided on the outer edge. The flexible pressure edge 7 is made of medical-grade soft silicone, 0.5mm thick, for vertically conforming to the skin surface, providing stable support and preventing liquid leakage.

[0047] The metering chamber 2 is located in the upper middle section inside the cap body 1. It is a cylindrical, sealed cavity made of transparent medical-grade polystyrene (PS) for easy observation of the remaining liquid level. In this embodiment, the effective volume of the metering chamber 2 is precisely set to 5 μL, with a tolerance of ≤ ±0.5 μL, fully meeting the single-dose requirements of skin prick test standards. The metering chamber 2 is aseptically filled on the production line, pre-filled with standardized dust mite allergen prick test solution, sealed after filling, and individually aseptically packaged. No on-site liquid aspiration is required during use; it can be used directly after opening the package.

[0048] The micropore / capillary channel 3 is vertically positioned directly below the quantitative chamber 2. It is a single straight-hole channel with an inner diameter of 0.2 mm and a length of 1.5 mm. The upper end connects to the liquid outlet at the bottom of the quantitative chamber 2, and the lower end connects directly to the central area of ​​the lower opening 6 of the cap. The inner wall of the channel is hydrophilically treated. When not in use, the pricking fluid is stably retained in the channel by surface tension and capillary action, without dripping or leaking. When the lower opening 6 is in contact with the skin, the liquid automatically and rapidly spreads in the detection area under the action of skin surface tension, achieving pressureless and precise liquid drainage.

[0049] The puncture needle 4 is precision-machined from medical-grade 304 stainless steel, with a needle diameter of 0.3mm and a needle tip angle of 15°, ensuring sharp puncture and minimal trauma. The puncture needle 4 is coaxially mounted on the central axis of the cap 1. In its initial state, the needle tip retracts and hides above the outlet of the micropore / capillary channel 3, ensuring sterility and safety by not exposing it or contacting the outside. The upper end of the puncture needle 4 is fixedly connected to the lower end of the linkage push rod 53 of the triggering mechanism 5, moving synchronously with the push rod.

[0050] The triggering mechanism 5 is integrated into the upper part of the cap body 1, including a pressing cap 51, a return spring 52, a linkage push rod 53, and an internal limiting groove. The pressing cap 51 is a circular anti-slip top cover with the same diameter as the cap body 1; the return spring 52 is a medical stainless steel compression spring, sleeved on the outside of the linkage push rod 53, with its upper end abutting against the pressing cap 51 and its lower end abutting against the internal stepped surface of the cap body 1; the linkage push rod 53 is a rigid plastic rod, with its upper part connected to the pressing cap 51 and its lower part connected to the puncture needle 4, and a liquid-pressing protrusion in the middle section, corresponding to the upper elastic diaphragm of the metering chamber 2.

[0051] The device operation flow in this embodiment is as follows:

[0052] Unpack the sterile packaging, hold the cap body 1 by the non-slip part, align the lower opening 6 vertically with the inner forearm skin, and gently press to make the ring flexible edge 7 fit tightly against the skin;

[0053] When the thumb gently presses the cap 51, it overcomes the elastic force of the reset spring 52 and moves downward. The linkage push rod 53 moves downward in sync, and the liquid-pressing boss squeezes the elastic membrane on the upper part of the metering chamber 2, so that the 5μL of puncture liquid in the metering chamber 2 is pressurized and quickly discharged through the micropores / capillary channels 3 and evenly spread on the skin surface.

[0054] Continue pressing down until the limit slot is locked, and the linkage push rod 53 drives the puncture needle 4 to extend downward into the lower opening 6, gently puncturing the epidermal layer of the skin to complete the puncture operation;

[0055] After maintaining contact for 1 second, release the pressing cap 51. The reset spring 52 will automatically rebound, pushing the pressing cap 51, the linkage push rod 53, and the puncture needle 4 to reset and retract synchronously.

[0056] The device is removed vertically to complete a single puncture, and the device is disposed of as disposable medical waste.

[0057] The above embodiments address the following issues: 1. Difficulty in controlling the amount of liquid added: Operators rely on experience to add liquid, resulting in significant differences in liquid volume between different operators and different operations, affecting the consistency of results. 2. Reagent waste: Allergen reagents are expensive, and excessive addition causes unnecessary waste. 3. Multiple operation steps: The two-step process of dripping and pricking results in low operational efficiency and poses risks such as liquid drying and contamination.

[0058] Example 2

[0059] The structure of this embodiment is basically the same as that of Embodiment 1, except that: the volume of the quantitative chamber 2 is set to 10μL, which is suitable for allergen detection with high viscosity or requiring a larger coverage area; the quantitative chamber 2 is provided with a closable aspiration port at the upper end, and does not adopt a pre-filling method. In clinical use, it can be directly inserted under the liquid surface of the reagent bottle, and the quantitative liquid is automatically aspirated by negative pressure to complete the quantitative filling; the micropore / capillary channel 3 adopts a three-hole array structure, which makes the liquid drainage more uniform; the diameter of the annular flexible pressing edge 7 is increased to 5mm to improve the adhesion stability.

[0060] The sequence numbers of the above embodiments of the present invention are for descriptive purposes only and do not represent the superiority or inferiority of the embodiments.

[0061] In the above embodiments of the present invention, the descriptions of each embodiment have different focuses. For parts not described in detail in a certain embodiment, please refer to the relevant descriptions of other embodiments.

[0062] In the several embodiments provided in this application, it should be understood that the disclosed technical content can be implemented in other ways. The device embodiments described above are merely illustrative; for example, the division of units can be a logical functional division, and in actual implementation, there may be other division methods. For instance, multiple units or components may be combined or integrated into another system, or some features may be ignored or not executed. Furthermore, the displayed or discussed mutual coupling, direct coupling, or communication connection may be through some interfaces; the indirect coupling or communication connection between units or modules may be electrical or other forms.

[0063] The units described as separate components may or may not be physically separate. The components shown as units may or may not be physical units; that is, they may be located in one place or distributed across multiple units. Some or all of the units can be selected to achieve the purpose of this embodiment according to actual needs.

[0064] In the several embodiments provided in this application, it should be understood that the disclosed technical content can be implemented in other ways. The device embodiments described above are merely illustrative; for example, the division of units can be a logical functional division, and in actual implementation, there may be other division methods. For instance, multiple units or components may be combined or integrated into another system, or some features may be ignored or not executed. Furthermore, the displayed or discussed mutual coupling, direct coupling, or communication connection may be through some interfaces; the indirect coupling or communication connection between units or modules may be electrical or other forms.

[0065] The units described as separate components may or may not be physically separate. The components shown as units may or may not be physical units; that is, they may be located in one place or distributed across multiple units. Some or all of the units can be selected to achieve the purpose of this embodiment according to actual needs.

[0066] Furthermore, the functional units in the various embodiments of the present invention can be integrated into one processing unit, or each unit can exist physically separately, or two or more units can be integrated into one unit. The integrated unit can be implemented in hardware or as a software functional unit.

[0067] If the integrated unit is implemented as a software functional unit and sold or used as an independent product, it can be stored in a computer-readable storage medium. Based on this understanding, the technical solution of the present invention, in essence, or the part that contributes to the prior art, or all or part of the technical solution, can be embodied in the form of a software product. This computer software product is stored in a storage medium and includes several instructions to cause a computer device (which may be a personal computer, server, or network device, etc.) to execute all or part of the steps of the methods described in the various embodiments of the present invention. The aforementioned storage medium includes various media capable of storing program code, such as USB flash drives, read-only memory (ROM), random access memory (RAM), portable hard drives, magnetic disks, or optical disks.

[0068] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A skin pricking device with a quantitative structure, characterized in that, The device includes a cap, a metering chamber, micropores / capillary channels, a puncture needle, and a triggering mechanism. The cap is a cylindrical / cover-shaped structure with an open lower end, which is used to fit the skin surface. The metering chamber is located inside the cap and is a liquid storage chamber with a fixed volume. The micropores / capillary channels connect the metering chamber to the lower opening of the cap. The puncture needle is located inside the cap, and the triggering mechanism controls the release of liquid and the extension of the puncture needle.

2. The method according to claim 1, characterized in that, The quantitative chamber is a preset fixed volume chamber with a volume specification of 5μL, 10μL or 15μL, used to accurately contain the pricking fluid required for a single test.

3. The method according to claim 1, characterized in that, The micropore / capillary channel has a single-pore or multi-pore structure, and the puncture fluid is quantitatively discharged through surface tension or slight squeezing of the cap.

4. The method according to claim 1, characterized in that, The puncture needle is located on the central axis of the cap. The needle tip is initially hidden inside the cap and extends out of the lower opening of the cap after being triggered to complete the puncture.

5. The skin pricking device according to claim 1, characterized in that, The triggering mechanism is an elastic pressing structure that enables the sequential action of first draining fluid and then pricking.

6. The skin pricking device according to claim 1, characterized in that, The metering chamber can be pre-filled with puncture fluid, or metered with puncture fluid via negative pressure aspiration.

7. The skin pricking device according to claim 1, characterized in that, The lower opening of the cap is a planar annular structure, used for vertical sealing and fitting against the skin surface.

8. The skin pricking device according to claim 1, characterized in that, The puncture needle is a disposable medical stainless steel needle body, which is integrally formed with the cap body or can be detachably connected.

9. The skin pricking device according to claim 5, characterized in that, The elastic pressing structure includes a spring, a pressing cap, and a linkage rod. Pressing the pressing cap drives the linkage rod to complete the drainage and puncture actions in sequence.

10. The skin pricking device according to claim 1, characterized in that, The device is an integrated disposable structure, with the quantitative chamber, micropore / capillary channel, puncture needle and triggering mechanism all integrated inside the cap.

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