Dry eye detection kit and detection method

By designing a dry eye detection kit and using a pipette to dip tears and then drop in diluent, the problems of the existing dry eye detection methods being cumbersome and requiring high professional skills have been solved, thus achieving safe and efficient self-detection.

CN120652090APending Publication Date: 2025-09-16JIANGSU BEIFENG MEDICAL TECH CO LTD
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Patent Information

Application Number
CN202510910474.8
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-07-02
Publication Date
2025-09-16

AI Technical Summary

Technical Problem

Existing dry eye testing methods are cumbersome, difficult, and require high professional skills. Sampling carries the risk of discomfort and potential eye damage, and can only be performed in professional medical institutions.

Method used

A dry eye detection kit is designed, which includes a detection kit body and a liquid sampler. Tears are dipped into a liquid pipette block and a diluent is dripped into the sample adding slot, which simplifies the operation process and realizes self-testing.

Benefits of technology

It achieves safe and efficient tear sampling and testing, is simple and easy to operate, does not require professionals, avoids sampling discomfort and the risk of eye contact, and is suitable for self-testing.

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Abstract

The invention discloses a dry eye detection kit, and relates to the technical field of detection kits.The dry eye detection kit comprises a detection kit body, test paper is fixedly arranged in the detection kit body, a sample adding groove and an observation groove are formed in the positions, corresponding to the test paper, of the top of the detection kit body, and the dry eye detection kit further comprises a liquid sampler rotationally connected to the detection kit body; a dipping part is arranged at the position, corresponding to the sample adding groove, of the liquid sampler, a liquid suction block is fixedly arranged on the side, located in the sample adding groove, of the dipping part, when the liquid sampler and the detection box body are overlapped, the liquid suction block abuts against the test paper, and an observation window matched with the liquid sampler in size is arranged at the position, corresponding to the observation groove, of the liquid sampler. The invention further provides a dry eye detection method. By adopting the structural design that the detection box and the sampler are integrated, on one hand, tears can be safely and efficiently sampled, and on the other hand, self-detection can be completed by adopting a mode of directly dripping a diluent, so that the detection process is simplified, and the operation is simpler and more feasible.
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Description

Technical Field

[0001] The present invention belongs to the technical field of detection kits, and in particular relates to a dry eye detection kit and a detection method. Background Art

[0002] MMP-9 is a non-specific inflammatory marker that has been shown to be elevated in the tears of patients with dry eye. Increased MMP-9 activity in the tears of patients with dry eye (keratoconjunctivitis sicca) may lead to corneal epithelial barrier dysfunction, increased corneal epithelial shedding, and corneal surface irregularities. The normal level of MMP-9 in normal human tears is between 3 and 40 ng / ml. Clinical results have shown that patients with moderate to severe dry eye have increased concentrations of MMP-9 in their tears. When the MMP-9 content in tears is higher than 40 ng / mL, it indicates a risk of dry eye. In order to detect the concentration of MMP-9 in tears, tears need to be collected. There are currently two sampling methods used for dry eye detection kits on the market. The first one is Figure 1 As shown, an L-shaped test strip is used, one end of the L-shaped test strip is inserted between the eyelid and the eyeball, and the test strip is soaked to complete the sampling; the second method is as shown in FIG. Figure 2 As shown, the eye is rinsed with a reagent solution. A reagent bottle is placed under the eye to collect the rinse mixture. Current sampling methods on the market have the following disadvantages: 1. Sampling methods have multiple and cumbersome steps; 2. Sampling is difficult, requiring the sampler to possess certain technical experience or professional training; 3. Sampling can only be performed by professional medical staff in specialized medical institutions; 4. The use of test strips or reagent solutions for rinsing directly contacts the eyeball, posing a risk of unnecessary damage; 5. The use of test strips can cause a foreign body sensation in the eye, resulting in a poor user experience; 6. Sampling is more difficult for those with sensitive or highly reactive eyes; 7. The test strips or reagent solutions contain chemicals other than water, which may cause other complications or post-test complications in individuals susceptible to eye rejection or special testing populations. To this end, we designed and proposed a dry eye detection kit. Summary of the Invention

[0003] The present invention aims to address the shortcomings of the prior art, such as cumbersome and difficult sampling, high professional skill requirements, and discomfort associated with sampling, by providing a dry eye detection kit. The dry eye detection kit enables safe and efficient tear sampling and is simple and easy to operate.

[0004] In order to achieve the above object, the present invention adopts the following technical solutions: A dry eye detection kit is designed, comprising a detection box body, wherein a test strip is fixedly provided in the detection box body, a sample loading slot and an observation slot are provided at the top of the detection box body corresponding to the position of the test strip, and a liquid sampler is also provided. The liquid sampler is rotatably connected to the detection box body, and a dipping portion is provided at a position of the liquid sampler corresponding to the sample loading slot, and a liquid absorption block is fixedly provided on one side of the dipping portion located inside the sample loading slot. When the liquid sampler overlaps with the detection box body, the liquid absorption block rests on the test strip, and an observation window of an adapted size is provided at a position of the liquid sampler corresponding to the observation slot.

[0005] Furthermore, the liquid sampler is adapted to the outer dimensions of the detection box body, so that the liquid sampler is snapped onto the detection box body.

[0006] Furthermore, the liquid sampler is connected to the tail of the detection box body, and shaft holes are provided on both sides of the tail of the detection box body. Rotating shafts are provided on both sides of the tail of the liquid sampler, and the rotating shafts are rotatably connected in the corresponding shaft holes.

[0007] Furthermore, limiting protrusions are provided on both sides of one end of the liquid sampler away from the rotating shaft. When the liquid sampler is buckled on the detection box body, matching limiting holes are provided on both sides of the detection box body corresponding to the positions of the limiting protrusions.

[0008] Furthermore, concave guide grooves are provided on both sides of the detection box body and at the position of the limiting hole. The guide grooves are arc-shaped grooves, and the radius of the arc-shaped grooves is the same as the rotation radius of the limiting protrusions.

[0009] Furthermore, a bending portion is provided at the connection between the dipping portion and the liquid sampler. When the liquid sampler is buckled onto the detection box body, the bending portion enables the dipping portion to extend into the sample loading groove.

[0010] Furthermore, the liquid-absorbing block is an elastic block with a porous structure made of a water-absorbing material.

[0011] In order to solve the above technical problems, the present invention also proposes a dry eye detection method, which uses the dry eye detection kit and includes the following steps: Step 1: After the subject produces tears on their own, pull open the lower eyelid; Step 2: unfold the liquid sampler from the test box body, and gently press the liquid absorbing block on the eyelid to collect tears; Step 3: Close the liquid sampler and the test box body, so that the dipping part enters the sample adding groove; Step 4, dripping the diluent into the sample adding tank; Step 5: Observe the test results through the observation slot.

[0012] The present invention proposes a dry eye detection kit, which has the following beneficial effects: the present invention adopts a structural design that integrates the detection box and the sampler. On the one hand, it can safely and efficiently complete tear sampling. On the other hand, it can complete self-testing by directly dripping a diluent, simplifying the detection process and making the operation simpler and easier. Specifically, when sampling, the eyeball is not touched, and the tear fluid on the lower eyelid is dipped into the liquid collector's liquid block. The liquid block is an elastic block made of a water-absorbing material, which is a material that is biologically guaranteed for daily use and will not be harmful to the human body. The operation method is simple, and sampling and testing can be completed by reading the instructions or familiarizing yourself with the operating procedures. There is no need to go to a professional medical institution for professional medical staff to take samples and test. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] The accompanying drawings are used to provide a further understanding of the present invention and constitute a part of the specification. Together with the embodiments of the present invention, they are used to explain the present invention and do not constitute a limitation of the present invention. In the accompanying drawings: Figure 1 It is a schematic diagram of the existing L-shaped test strip sampling; Figure 2 It is a schematic diagram of the existing method of flushing and sampling with reagent solution; Figure 3 It is a schematic diagram of the three-dimensional structure of the present invention; Figure 4 It is a schematic diagram of the internal structure of the present invention; Figure 5 is a schematic diagram of the deployment process of the liquid sampler in the present invention; Figure 6 It is a structural diagram of the detection box body in the present invention; Figure 7 It is a structural schematic diagram of a liquid sampler in the present invention; Figure 8 It is a schematic diagram of sampling of the present invention; The markings in the figure are: 1. Detection box body; 11. Sample loading slot; 12. Observation slot; 13. Axis hole; 14. Guide slot; 15. Limiting hole; 2. Test paper; 3. Liquid sampler; 31. Dipping part; 32. Bending part; 33. Observation window; 34. Rotating shaft; 35. Limiting protrusion; 4. Liquid absorption block. DETAILED DESCRIPTION

[0014] The technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention; it is obvious that the described embodiments are only part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention.

[0015] In the description of the present invention, it should be noted that the terms "upper", "lower", "inner", "outer", "top / bottom" and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings. They are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation. Therefore, they should not be understood as limiting the present invention.

[0016] In the description of the present invention, it should be noted that, unless otherwise expressly specified or limited, the terms "installed," "provided with," "mounted / connected," and "connected" should be understood in a broad sense. For example, "connected" can mean a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, and it can be internal communication between two components. Those skilled in the art will be able to understand the specific meanings of the above terms in the present invention in specific circumstances.

[0017] The structural features of the present invention will now be described in detail with reference to the accompanying drawings.

[0018] Example 1 See also Figure 3-7 A dry eye detection kit includes a detection box body 1, in which a test strip 2 is fixed. The test strip 2 is used to detect MMP-9 in tears. A sample addition slot 11 and an observation slot 12 are provided at the top of the detection box body 1 corresponding to the position of the test strip 2. The sample addition slot 11 is used for adding diluent and test liquid, and the observation slot 12 is used to observe the test results. A C line and a T line may be provided on one side of the observation slot 12, and the test results include positive, negative or invalid, respectively.

[0019] The liquid sampler 3 is also included. The liquid sampler 3 is adapted to the external dimensions of the detection box body 1 so that the liquid sampler 3 is buckled on the detection box body 1 and the liquid sampler 3 is rotatably connected to the detection box body 1. Specifically, the liquid sampler 3 is connected to the tail of the detection box body 1. The tail of the detection box body 1 is provided with an axis hole 13 on both sides. The tail of the liquid sampler 3 is provided with a rotating shaft 34 on both sides. The rotating shaft 34 is rotatably connected in the corresponding axis hole 13. Under the connection between the axis hole 13 and the rotating shaft 34, the liquid sampler 3 can be rotated and unfolded from the detection box body 1. In order to make the liquid sampler 3 buckled on the detection box body 1 more stable, when the liquid sampler 3 is away from the detection box body 1, the liquid sampler 3 can be rotated and unfolded from the detection box body 1. Limiting protrusions 35 are provided on both sides of one end of the rotating shaft 34, and matching limiting holes 15 are provided on both sides of the detection box body 1 at the positions corresponding to the limiting protrusions 35. When the liquid sampler 3 is buckled on the detection box body 1, the limiting protrusion 35 can be snapped into the limiting hole 15, so that the liquid sampler 3 is temporarily fixed on the detection box body 1. In order to make the limiting protrusion 35 better enter the limiting hole 15, concave guide grooves 14 are provided on both sides of the detection box body 1 and at the position of the limiting hole 15. The guide groove 14 is an arc groove, and the radius of the arc groove is the same as the rotation radius of the limiting protrusion 35. Under the action of the guide groove 14, the limiting protrusion 35 is easier to screw into the limiting hole 15.

[0020] The liquid sampler 3 is provided with a dipping portion 31 at the position corresponding to the sample loading slot 11, and a bending portion 32 is provided at the connection between the dipping portion 31 and the liquid sampler 3. When the liquid sampler 3 is buckled into the detection box body 1, the bending portion 32 allows the dipping portion 31 to extend into the sample loading slot 11. A liquid absorbing block 4 is fixedly provided on one side of the dipping portion 31 located inside the sample loading slot 11. The liquid absorbing block 4 is an elastic block with a porous structure made of a water-absorbing material, such as a sponge block. When the liquid sampler 3 overlaps with the detection box body 1, the liquid absorbing block 4 rests on the test paper 2. When the liquid sampler 3 is buckled into the detection box body 1, in order to be able to observe the observation slot 12, an observation window 33 of a suitable size is provided at the position of the liquid sampler 3 corresponding to the observation slot 12.

[0021] The dry eye detection kit of the present invention is easy to operate. It can safely and efficiently sample tears. Furthermore, it allows for self-testing by directly dripping a diluent during use, simplifying the testing process and making it easier to operate. During sampling, the liquid sampler 3 does not contact the eyeball. Instead, the liquid sampler 3's wicking block 4 is used to collect tears from the lower eyelid. The operation is simple, safe, and discomfort-free. Users only need to read the instructions or familiarize themselves with the operating procedures to complete sampling and testing, eliminating the need to visit a professional medical institution for sampling and testing by professional medical staff.

[0022] Example 2 Reference Figure 8As another preferred embodiment of the present invention, the difference from Example 1 is that this embodiment proposes a dry eye detection method, which uses a dry eye detection kit to perform dry eye detection, and specifically includes the following steps: Step 1: After the subject produces tears on their own, pull open the lower eyelid; Step 2: unfold the liquid sampler 3 from the test box body 1, and gently press the liquid absorbing block 4 on the eyelid to collect tears; Step 3: Close the liquid sampler 3 and the detection box body 1, so that the dipping portion 31 enters the sample loading slot 11; Step 4: Add diluent to the sample adding tank 11; Step 5: Observe the test results of the test paper 2 through the observation slot 12.

[0023] The test results include: ①. Two red lines are visible to the naked eye, one is the C line (quality control line) and the other is the T line (test line). The results should be interpreted as positive. A positive result indicates possible dry eye syndrome, and the color of the T line (test line) in the test area is regardless of the depth; ②. Only one red C line (quality control line) is visible to the naked eye. The result should be interpreted as negative. A negative result indicates a normal level; ③. No red line is visible to the naked eye or only the T line (test line) appears without the C line (quality control line), indicating that the test item is wrong or the test result is invalid. It is recommended to retest with a new test kit.

[0024] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art will be able to modify the technical solutions described in the aforementioned embodiments or replace some of the technical features therein with equivalents. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principles of the present invention shall be included within the scope of protection of the present invention.

Claims

1. A dry eye detection kit, comprising a detection box body (1), wherein a test strip (2) is fixedly provided in the detection box body (1), and a sample addition slot (11) and an observation slot (12) are provided at the top of the detection box body (1) corresponding to the position of the test strip (2), characterized in that: It also includes a liquid sampler (3), the liquid sampler (3) is rotatably connected to the detection box body (1), the liquid sampler (3) is provided with a dipping portion (31) at a position corresponding to the sample loading groove (11), and the dipping portion (31) is located on one side inside the sample loading groove (11) and is fixed with a liquid absorption block (4); When the liquid sampler (3) and the detection box body (1) overlap, the liquid absorption block (4) abuts against the test paper (2); The liquid sampler (3) is provided with an observation window (33) of suitable size at a position corresponding to the observation tank (12).

2. A dry eye detection kit according to claim 1, characterized in that The liquid sampler (3) is adapted to the external dimensions of the detection box body (1), so that the liquid sampler (3) is snapped onto the detection box body (1).

3. A dry eye detection kit according to claim 1, characterized in that: The liquid sampler (3) is connected to the rear of the detection box body (1), and shaft holes (13) are provided on both sides of the rear of the detection box body (1). Rotating shafts (34) are provided on both sides of the rear of the liquid sampler (3), and the rotating shafts (34) are rotatably connected in the corresponding shaft holes (13).

4. A dry eye detection kit according to claim 3, characterized in that: Limiting protrusions (35) are provided on both sides of one end of the liquid sampler (3) away from the rotating shaft (34). When the liquid sampler (3) is buckled onto the detection box body (1), matching limiting holes (15) are provided on both sides of the detection box body (1) at positions corresponding to the limiting protrusions (35).

5. A dry eye detection kit according to claim 4, characterized in that: On both sides of the detection box body (1), and at the position of the limiting hole (15), there are provided inwardly concave guide grooves (14), the guide grooves (14) being arc-shaped grooves, the radius of which is the same as the rotation radius of the limiting protrusion (35).

6. A dry eye detection kit according to claim 1, characterized in that: A bent portion (32) is provided at the connection between the dipping portion (31) and the liquid sampler (3); when the liquid sampler (3) is buckled onto the detection box body (1), the bent portion (32) enables the dipping portion (31) to extend into the sample loading slot (11).

7. A dry eye detection kit according to claim 1, characterized in that: The liquid absorbing block (4) is an elastic block with a porous structure made of a water absorbing material.

8. A dry eye detection method, using the dry eye detection kit according to any one of claims 1 to 7, characterized in that: The steps include: Step 1: After the subject produces tears on their own, pull open the lower eyelid; Step 2: unfold the liquid sampler (3) from the detection box body (1), and gently press the liquid absorbing block (4) on the eyelid to collect tears; Step 3: closing the liquid sampler (3) and the detection box body (1), so that the dipping portion (31) enters the sample adding groove (11); Step 4, dripping the diluent into the sample adding tank (11); Step 5: Observe the result of the test paper (2) through the observation slot (12).