Skin test positive measuring device
Patent Information
- Application Number
- CN202611175098.3
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2026-08-04
- Publication Date
- 2026-11-03
AI Technical Summary
现有的皮试阳性测量器依赖医护人员肉眼观察皮丘的直径和颜色,存在判读偏差,功能单一,未集成比色和判读指南,且未考虑人因工程学,导致误判和操作不便。
A skin test positive measuring device was designed, which integrates a standard scale, color ring, and interpretation guide. It adopts a multi-gradient color ring and precise scale, conforms to ergonomics, is suitable for one-handed operation, and combines scientific optical calibration to ensure accurate interpretation under different lighting conditions. It is integrated into a storage box for easy carrying and use.
It enables rapid and accurate interpretation of skin test results, reduces operational intensity and the risk of misjudgment, improves the repeatability and impartiality of results, is applicable to various skin test types and populations, extends service life, reduces costs and misjudgment rates, and promotes the standardization and quality management of nursing procedures.
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Figure CN123023899A_ABST
Abstract
Description
Technical Field
[0001] This invention relates to the field of medical device technology, and more particularly to a skin test positive measuring device. Background Technology
[0002] A skin test (skin sensitivity test) is a medical examination that detects whether the body is allergic to a specific drug or substance by injecting a small amount of a suspected allergen into the skin and observing whether reactions such as redness, swelling, or induration occur. Its core purpose is to predict possible immediate allergic reactions (such as anaphylactic shock) and thus avoid serious risks. Clinically, skin tests are mainly used for drug allergy testing (such as penicillin and cephalosporins) and as an auxiliary diagnostic tool for certain infectious diseases.25 During the procedure, medical staff will disinfect the skin and inject the test solution intradermally. The result is determined based on the reaction at the injection site after 15-20 minutes. To prevent allergic reactions, especially severe allergic reactions, regulations stipulate that some drugs that are prone to causing allergic reactions require a skin sensitivity test before use. Drugs with a negative skin test can be used by patients, while those with a positive skin test are prohibited from use. These drugs that require a skin test are called skin test drugs; skin testing is an immunological detection method that relies on the reaction of antigens and antibodies in or on the skin. Based on different reaction mechanisms, skin tests can be divided into two main categories: one is the neutralization reaction skin test, which can observe the body's humoral immune status; the other is the hypersensitivity reaction skin test, which is used to detect the body's hypersensitivity reaction and cellular immune status. The Sick test is a skin test used to measure susceptibility or immunity to diphtheria. The method involves injecting a certain amount of diphtheria toxin intradermally into the flexor surface of the subject's forearm. If the subject has no immunity, local skin redness and swelling with a diameter of 1-2 cm will appear within 24-48 hours, indicating a positive reaction. Conversely, if the subject has immunity, their serum contains sufficient antitoxin antibodies to neutralize the injected toxin, and no local redness or swelling will appear, indicating a negative reaction. This test, in addition to determining susceptibility to diphtheria, can also detect whether immunity has been developed after diphtheria vaccination. Its essence is the in vivo neutralization reaction of toxin and antitoxin. Type I hypersensitivity reaction (see hypersensitivity reaction) skin test is a reaction between the allergen and the specific antibody IgE (immunoglobulin E) in the skin. Antigens that cause type I hypersensitivity reactions can induce redness and swelling within 10 to 20 minutes after injection or scratching, such as penicillin skin tests and heterologous animal serum skin tests.
[0003] A skin test positive measuring device is a tool used in medicine to assist in interpreting the results of skin allergy tests. Through standardized measurement, it reduces subjective error and improves the accuracy and efficiency of the assessment. Its core purpose is to help healthcare professionals more accurately identify positive skin test reactions. For example, in cephalosporin skin tests, it can quickly analyze the test data and provide a result within a short time, avoiding misjudgments or omissions that may occur with manual measurement. In the tuberculin skin test (PPD test), it is used to measure the diameter of the induration on the skin 72 hours after injection, a key indicator for determining whether there is a tuberculosis infection.
[0004] Existing skin test positive measuring devices rely on medical staff to visually observe the "redness / induration diameter" of the wheal. However, differences in experience and vision among different operators can lead to interpretation errors. The device is relatively simple in function, only measuring the diameter, and does not integrate functions such as colorimetry and interpretation guidelines. It still relies on human experience. Furthermore, it does not consider ergonomics (such as one-handed operation), and the colorimetric design is not optimized for the optical characteristics of skin redness, making it prone to misinterpretation under different lighting conditions.
[0005] Therefore, how to provide a skin test positive measuring device is a problem that urgently needs to be solved by those skilled in the art. Summary of the Invention
[0006] One object of the present invention is to provide a skin test positive measuring device to solve the problems mentioned in the background art.
[0007] According to an embodiment of the present invention, a skin test positive measuring device includes a storage box, the storage box having multiple storage slots inside, a fixed shaft fixedly installed inside the storage box, a through hole opened inside the fixed shaft, a measuring device body being disposed inside the storage slots, a connecting arm fixedly connected to the outside of the measuring device body, a connecting hole opened at one end of the connecting arm, and a fixed shell fixedly installed on the outside of the storage box.
[0008] As a further preferred embodiment of the present invention: the inner diameter of the storage groove is adapted to the outer diameter of the measuring instrument body, and the measuring instrument body is movably connected to the storage groove.
[0009] As a further preferred embodiment of the present invention: multiple measuring device bodies are provided, and the measuring device bodies are symmetrically distributed vertically inside the storage slot.
[0010] As a further preferred embodiment of the present invention: a groove is provided in the center of the measuring instrument body, a color matching ring is provided on the measuring instrument body, a scale is provided on the measuring instrument body, a limit hole is opened on the outer side of the measuring instrument body, multiple color matching rings are provided, and the distance between the color matching rings is 1cm, and a reading guide number is provided at the interval of the color matching rings.
[0011] As a further preferred embodiment of the present invention: the color matching circle adopts a bold red line, and the color gradient of the color matching circle includes light pink, peach pink and dark red, and the color difference ΔE of each color gradient is ≥15.
[0012] As a further preferred embodiment of the present invention: the bottom of the measuring device body is provided with a base layer, the top of the base layer is provided with a reinforcing layer, the top of the reinforcing layer is provided with a functional printing layer, and the top of the functional printing layer is provided with a protective coating. The base layer is made of silver ion antibacterial modified polypropylene + medical grade polyethylene blend material + glass fiber material, and the reinforcing layer is made of polycarbonate material.
[0013] As a further preferred embodiment of the present invention: the functional printing layer is made of food-grade environmentally friendly ink + ultraviolet curing resin process, and the protective coating is made of medical-grade polyurethane coating + nano silica + fluorocarbon resin material.
[0014] As a further preferred embodiment of the present invention: the inner diameter of the connecting hole is adapted to the outer diameter of the fixed shaft, the connecting arm is sleeved on the fixed shaft through the connecting hole, and the connecting arm is rotatably connected to the storage box through the fixed shaft.
[0015] As a further preferred embodiment of the present invention: the fixed shell is provided with a movable groove, a spring is installed inside the movable groove, one end of the spring is connected to a limit pin, and a toggle block is fixedly connected to one side of the limit pin.
[0016] As a further preferred embodiment of the present invention: multiple limiting pins are provided, and one end of each limiting pin corresponds to the measuring device body. The outer diameter of one end of the limiting pin is adapted to the inner diameter of the limiting hole, and the limiting pin is movably inserted into the limiting hole.
[0017] The beneficial effects of this invention are: 1. This skin test positive measuring device integrates a standard scale, colorimetric ring, and interpretation guide. During operation, simply align the center of the device with the wheal to quickly measure the diameter and compare the results. This transforms the estimation process, which relies on personal experience, into an objective standard comparison process, achieving a three-in-one function of "precise measurement - standard comparison - rapid judgment". Medical staff do not need to carry or switch between multiple tools. The interpretation time for a single skin test is reduced from the traditional 2-3 minutes to within 30 seconds, significantly reducing the intensity of nursing operations. It is especially suitable for scenarios with high demand for skin tests, such as outpatient and emergency departments. It pioneers the "center alignment, ring comparison" interpretation mode, transforming abstract textual standards into a concrete visual ruler. This eliminates interpretation differences between different operators, ensuring high repeatability and fairness of results and promoting the standardization of nursing procedures. The ergonomic layout and single-handed operation are well-suited for operation. Combined with scientifically calibrated colorimetric rings, it ensures that skin wheal alignment, diameter reading, and rosacea comparison can be quickly completed under different lighting conditions. The operation process is intuitive and simple, and novice nurses can master it after simple training, thus lowering the operational threshold.
[0018] 2. This skin test positive measuring device, through its structural design, is not only suitable for the daily interpretation of clinical skin tests, but also serves as a standardized teaching tool for the training and assessment of new nurses. It provides a quantitative evaluation basis for teaching through objective interpretation standards, helping novices quickly master skin test interpretation skills and shortening the training cycle by more than 30%. At the same time, it provides a clear standard reference for internal quality control inspections in medical institutions, facilitating the quantitative assessment of the standardization of nursing operations and building an effective bridge between clinical practice and quality management.
[0019] 3. This skin test positive measuring device integrates multiple different measuring device bodies inside the storage box, making it compatible with common clinical skin tests such as penicillin, PPD, and tetanus antitoxin. Combined with a multi-gradient colorimetric ring and precise scale design, it can meet the interpretation needs of different skin test types and is suitable for clinical applications in different populations, including adults and children, demonstrating strong versatility. It also features a fixed shell structure with a movable groove, spring, and limiting pin inside. A toggle block is fixedly connected to one side of the limiting pin, and the limiting pin movably engages with a limiting hole on the outside of the measuring device body. During use, this design effectively limits and secures the measuring device body stored in the storage groove, preventing it from easily slipping out and facilitating easier carrying and use.
[0020] 4. This skin test positive measuring device uses antibacterial and chemically resistant medical polymer materials. After adding silver ion antibacterial agent, the antibacterial rate is ≥99.9%. The surface is coated with a polyurethane protective coating that is resistant to alcohol and iodine. It can withstand repeated disinfection and daily use. After 500 wipes with 75% alcohol, there is no fading or peeling. Its service life is more than 3 times longer than traditional tools, which not only reduces the cost of tool replacement, but also meets the requirements of hospital infection control.
[0021] 5. This skin test positive measuring device reduces the procurement and maintenance costs of scattered tools through its integrated functional design. Improved single-test reading efficiency lowers healthcare labor costs, and its durable design reduces consumable waste, saving operating costs for medical institutions. Simultaneously, accurate reading reduces the use of expensive alternative drugs due to false positives, lowering patient treatment costs. This invention transforms abstract skin test interpretation standards into standardized tools, promoting a shift in nursing procedures from "experience-based" to "standard-based," aligning with the trend of standardized quality management in the medical industry. It helps improve the quality of nursing services and industry competitiveness in medical institutions and has broad clinical application value. Attached Figure Description
[0022] The accompanying drawings are provided to further illustrate the invention and form part of the specification. They are used in conjunction with embodiments of the invention to explain the invention and do not constitute a limitation thereof. In the drawings: Figure 1 This is a schematic diagram of the overall skin test positive measuring device proposed in this invention.
[0023] Figure 2 This is a schematic diagram showing the storage of the main body of the skin test positive measuring device proposed in this invention.
[0024] Figure 3 This is a side view of the storage box for the skin test positive measuring device proposed in this invention.
[0025] Figure 4 This is a schematic diagram of the main body of the skin test positive measuring device proposed in this invention.
[0026] Figure 5 This is a schematic planar view of the main body of the skin test positive measuring device proposed in this invention.
[0027] Figure 6 This is a cross-sectional schematic diagram of the main body of the skin test positive measuring device proposed in this invention.
[0028] Figure 7 This is a schematic diagram of the fixing shell of the skin test positive measuring device proposed in this invention.
[0029] Figure 8 This is a cross-sectional schematic diagram of the fixed shell of the skin test positive measuring device proposed in this invention.
[0030] The attached diagram shows: 1. Storage box; 2. Storage slot; 3. Fixed shaft; 4. Through hole; 5. Measuring instrument body; 501. Groove; 502. Color matching ring; 503. Scale; 504. Limiting hole; 505. Base layer; 506. Reinforcing layer; 507. Functional printing layer; 508. Protective coating; 6. Connecting arm; 7. Connecting hole; 8. Fixed shell; 801. Movable groove; 802. Spring; 803. Limiting pin; 804. Toggle block. Detailed Implementation
[0031] The present invention will now be described in further detail with reference to the accompanying drawings. These drawings are simplified schematic diagrams, illustrating only the basic structure of the invention, and therefore only show the components relevant to the invention.
[0032] Please see Figures 1 to 8 In this implementation scheme: the skin test positive measuring device includes a storage box 1. The storage box 1 has multiple storage slots 2 inside, which can classify and protect multiple different measuring device bodies 5. A fixed shaft 3 is fixedly installed inside the storage box 1. The fixed shaft 3 has a through hole 4 inside, which is designed to facilitate the connection of a hanging rope, making it easier for medical staff to carry and use. The measuring device body 5 is set inside the storage slot 2, which is convenient for skin test measurement. A connecting arm 6 is fixedly connected to the outside of the measuring device body 5. One end of the connecting arm 6 has a connecting hole 7. The connecting arm 6 can be rotatably connected to the fixed shaft 3 through the connecting hole 7. A fixed shell 8 is fixedly installed on the outside of the storage box 1. The fixed shell 8 can limit and fix the measuring device body 5 stored in the storage slot 2, preventing the measuring device body 5 from easily sliding out of the storage slot 2.
[0033] refer to Figure 1 , Figure 2 , Figure 3 As shown, the inner diameter of the storage slot 2 is adapted to the outer diameter of the measuring instrument body 5. The measuring instrument body 5 is movably connected to the storage slot 2. The storage slot 2 can store and protect the measuring instrument body 5, facilitating better long-term working and use.
[0034] refer to Figure 1 , Figure 2 As shown, there are multiple measuring device bodies 5, which are symmetrically distributed inside the storage slot 2. Each measuring device body 5 is equipped with a colorimetric ring 502 of a different color. The colorimetric ring 502 of the corresponding color gradient can be replaced according to different skin test items (such as penicillin, PPD, tetanus), adapting to multiple skin test scenarios and avoiding the problem of insufficient adaptability of a single colorimetric ring 502.
[0035] refer to Figure 1 , Figure 4 , Figure 5As shown, the measuring instrument body 5 has a groove 501 in the center, a color matching ring 502, a scale 503, and a limiting hole 504 on the outer side. Multiple color matching rings 502 are provided, and the distance between the color matching rings 502 is 1cm. Interpretation guide numbers are provided at the intervals of the color matching rings 502. The measuring instrument body 5 integrates the standard scale, color matching rings 502, and interpretation guide into one unit. During operation, simply align its center with the pituitary gland to quickly measure the diameter and compare the results, transforming the estimation process that relies on personal experience into an objective standard comparison process.
[0036] refer to Figure 1 , Figure 4 , Figure 5 As shown, the color matching circle 502 uses a bold red line. The color gradient of the color matching circle 502 includes light pink corresponding to mild redness, peach pink corresponding to moderate redness, and dark red corresponding to severe redness. The color difference ΔE of each color gradient is ≥15CIEDE2000 color difference value, which can enhance the visual recognition of the positive standard, reduce the risk of overlooking during interpretation, and ensure the differentiation of different degrees of redness, thus solving the problem of color misjudgment under illumination.
[0037] refer to Figure 1 , Figure 6 As shown, the bottom of the measuring instrument body 5 is provided with a base layer 505, the top of the base layer 505 is provided with a reinforcing layer 506, the top of the reinforcing layer 506 is provided with a functional printing layer 507, and the top of the functional printing layer 507 is provided with a protective coating 508. The base layer 505 is made of a blend of silver ion antibacterial modified polypropylene (PP) and medical-grade polyethylene (PE) as a base material and glass fiber reinforcing agent. The reinforcing layer 506 is made of polycarbonate material, which can provide structural support and structural strength, antibacterial properties, and flexibility, and is suitable for repeated clinical use and disinfection.
[0038] refer to Figure 1 , Figure 6 As shown, the functional printing layer 507 is made of food-grade environmentally friendly ink for printing graduations / color rings / judgment guides and UV-cured resin ink fixative. The protective coating 508 is made of medical-grade polyurethane (PU) coating agent, nano-silica anti-scratch additive, and fluorocarbon resin anti-corrosion modifier. The graduations are made using high-resolution plate making with a straightness error of ≤0.05mm. The use of high-resolution plate making and precision printing processes ensures the absolute accuracy of all graduations and color rings 502, laying a reliable technical foundation for accurate measurement. The protective coating 508 gives the product excellent physical strength, allowing it to withstand repeated disinfection and daily use, resulting in a long lifespan and meeting hospital infection control requirements.
[0039] refer to Figure 1 , Figure 2 , Figure 3 , Figure 4 , Figure 5 As shown, the inner diameter of the connecting hole 7 is adapted to the outer diameter of the fixed shaft 3. The connecting arm 6 is sleeved on the fixed shaft 3 through the connecting hole 7. The connecting arm 6 is rotatably connected to the storage box 1 through the fixed shaft 3. By setting the connecting arm 6 to be rotatably connected to the storage box 1 through the fixed shaft 3, the measuring instrument body 5 can be driven to rotate during the rotation of the connecting arm 6, which makes it convenient to take out the measuring instrument body 5 for use or to store the measuring instrument body 5.
[0040] refer to Figure 1 , Figure 2 , Figure 7 , Figure 8 As shown, the fixed housing 8 has a movable groove 801 inside, a spring 802 installed inside the movable groove 801, and a limit pin 803 connected to one end of the spring 802. A toggle block 804 is fixedly connected to one side of the limit pin 803. There are multiple limit pins 803, and one end of each limit pin 803 corresponds to the measuring instrument body 5. The outer diameter of one end of the limit pin 803 is adapted to the inner diameter of the limit hole 504. The limit pin 803 is movably inserted into the limit hole 504. The limiting and movable connector can limit and fix the measuring instrument body 5 when it is stored, preventing the measuring instrument body 5 from easily sliding out of the storage slot 2. When the measuring instrument body 5 needs to be used, by sliding the toggle block 804 to one side, the limiting pin 803 is moved and adjusted so that one end of the limiting pin 803 is separated from the limiting hole 504. Then, by tilting the storage box 1 to one side, the measuring instrument body 5 corresponding to the skin test item (such as penicillin, PPD) will rotate with the connecting arm 6 around the fixed axis 3 and slide out of the storage slot 2, completing the tool retrieval.
[0041] Working principle: When the operator needs to interpret a skin test, they move the actuating block 804 on the fixed housing 8 to one side, causing the limiting pin 803 to compress the spring 802 and disengage from the limiting hole 504 on the outside of the measuring device body 5; then, tilting the storage box 1, the measuring device body 5 corresponding to the skin test item (such as penicillin, PPD) will rotate around the fixed axis 3 with the connecting arm 6 and slide out from the storage slot 2, completing the tool retrieval; the groove 501 in the center of the removed measuring device body 5 is placed against the center of the wheal at the skin test injection site, and the positioning effect of the groove 501 ensures that the measuring device body 5 is coaxial with the wheal, avoiding measurement errors caused by center offset; at the same time, the alignment status can be confirmed by the scale on the measuring device body 5; Diameter measurement: Observe the ring colorimetric circle 502 covering the red / hardened area of the wheal, and read the diameter value with the ruler 503. If the value is ≥1cm (the reading guide number marked at intervals of the colorimetric circle 502), it is preliminarily judged as positive. Redness comparison: The color comparison rings 502 on the measuring instrument, which are light pink (mild), peach pink (medium), and dark red (severe), are matched with the actual redness color of Pichu. The interpretation results are further verified by combining the diameter data to avoid misjudgment based on a single dimension.
[0042] After the reading is completed, the measuring instrument body 5 is rotated around the fixed shaft 3 via the connecting arm 6 and inserted into the corresponding storage slot 2 of the storage box 1; the toggle block 804 is released, the spring 802 is reset and pushes the limit pin 803 into the limit hole 504 of the measuring instrument body 5, thus completing the fixed storage of the measuring instrument body 5 and preventing it from slipping or being damaged.
[0043] The above description is only a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any equivalent substitutions or modifications made by those skilled in the art within the scope of the technology disclosed in the present invention, based on the technical solution and inventive concept of the present invention, should be covered within the scope of protection of the present invention.
Claims
1. A skin test positive measuring device, including a storage box (1), characterized in that: The storage box (1) has multiple storage slots (2) inside. A fixed shaft (3) is fixedly installed inside the storage box (1). A through hole (4) is opened inside the fixed shaft (3). A measuring device body (5) is installed inside the storage slot (2). A connecting arm (6) is fixedly connected to the outside of the measuring device body (5). A connecting hole (7) is opened at one end of the connecting arm (6). A fixed shell (8) is fixedly installed on the outside of the storage box (1).
2. The skin test positive measuring device according to claim 1, characterized in that, The inner diameter of the storage slot (2) is adapted to the outer diameter of the measuring instrument body (5), and the measuring instrument body (5) is movably connected to the storage slot (2).
3. The skin test positive measuring device according to claim 1, characterized in that, Multiple measuring device bodies (5) are provided, and the measuring device bodies (5) are symmetrically distributed inside the storage slot (2).
4. The skin test positive measuring device according to claim 1, characterized in that, The measuring instrument body (5) has a groove (501) at its center, a color matching ring (502) on its body, a scale (503) on its body, a limiting hole (504) on its outer side, multiple color matching rings (502) with a spacing of 1cm between them, and reading guide numbers at the intervals between the color matching rings (502).
5. The skin test positive measuring device according to claim 4, characterized in that, The color matching circle (502) uses a thick red line. The color gradient of the color matching circle (502) includes light pink (corresponding to mild blush), peach pink (corresponding to moderate blush), and dark red (corresponding to severe blush), and the color difference ΔE of each color gradient is ≥15 (CIEDE2000 color difference value).
6. The skin test positive measuring device according to claim 4, characterized in that, The measuring instrument body (5) has a base layer (505) at the bottom, a reinforcing layer (506) at the top of the base layer (505), a functional printing layer (507) at the top of the reinforcing layer (506), and a protective coating (508) at the top of the functional printing layer (507). The base layer (505) is made of silver ion antibacterial modified polypropylene (PP) + medical grade polyethylene (PE) blend material (substrate) + glass fiber (reinforcing agent) material, and the reinforcing layer (506) is made of polycarbonate material.
7. The skin test positive measuring device according to claim 6, characterized in that, The functional printed layer (507) is made of food-grade environmentally friendly ink (scale / color ring / judgment guide printing) + ultraviolet curing resin (ink fixative) process, and the protective coating (508) is made of medical-grade polyurethane (PU) coating (main agent) + nano silica (anti-scratch additive) + fluorocarbon resin (anti-corrosion modifier) material.
8. The skin test positive measuring device according to claim 1, characterized in that, The inner diameter of the connecting hole (7) is adapted to the outer diameter of the fixed shaft (3). The connecting arm (6) is sleeved on the fixed shaft (3) through the connecting hole (7). The connecting arm (6) is rotatably connected to the storage box (1) through the fixed shaft (3).
9. The skin test positive measuring device according to claim 1, characterized in that, The fixed shell (8) is provided with a movable groove (801), a spring (802) is installed inside the movable groove (801), one end of the spring (802) is connected to a limit pin (803), and a toggle block (804) is fixedly connected to one side of the limit pin (803).
10. The skin test positive measuring device according to claim 9, characterized in that, Multiple limit pins (803) are provided, and one end of each limit pin (803) corresponds to the measuring body (5). The outer diameter of one end of the limit pin (803) is adapted to the inner diameter of the limit hole (504), and the limit pin (803) is movably connected to the limit hole (504).
